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In 2019, Canada introduced legislative changes that made asylum seekers ineligible for protection if they have made a previous refugee claim in a country that Canada shares an information-sharing agreement with. Such agreements are currently in place with the US, Australia, the UK, and New Zealand. This article offers a critical assessment of the new ineligibility ground, arguing that the policy is designed to deter secondary refugee movements, particularly those across the Canada–US border which have considerably intensified since 2017. Based on the ‘first safe country’ rule, the new ineligibility ground enables Canada to exclude some asylum seekers from refugee protection without offering any alternative effective protection in Canada. This article demonstrates that the policy is inconsistent with Canada’s obligations under international refugee law.

Background Eligibility guidelines in research trials are necessary to minimise confounds and reduce bias in the interpretation of potential treatment effects. There is limited extant research investigating how being deemed ineligible for such trials might impact patients’ perceptions of themselves and of research. Better understanding of the impact of patient ineligibility could enhance design and implementation of future research studies. Methods Eight semi-structured telephone interviews were conducted to explore the impact of ineligibility on self-perceptions; perceptions regarding the nature of research; and the likelihood of expressing interest in future research. Data were collected and analysed thematically through inductive, interpretive phenomenological analysis (IPA). Results Five themes emerged regarding the experience of being deemed ineligible: (1) Being deemed ineligible is emotion and reaction evoking; (2) ‘Doing your bit’: Helping others and increasing the value of research; (3) Communication of ineligibility; (4) Appreciation for those who express interest; and (5) Subsequent perceptions and attitudes towards research. Conclusions The results suggest that being deemed ineligible can elicit negative emotional outcomes but is not likely to change perceptions of or attitudes towards research, possibly due to a desire to help similar others. Ineligibility can impact future participation in some cases, thus reducing the recruitment pool for subsequent research studies. Recommendations are provided to help minimise this risk. Advising of ineligibility in a personal way is recommended: with enhanced clarity regarding the reasoning behind the decision; providing opportunities to ask questions; and ensuring that appreciation for the patient’s time and interest are communicated.

This paper examines the proportionality of sanctions in the World Anti-Doping Code 2021 (“Code 2021”). The author argues that Code 2021 improved the proportionality of sanctions compared to the World Anti-Doping Code 2015 (“Code 2015”), but problems persist. Sanctioning framework of Code 2021 introduces several provisions that modify the basic period of ineligibility and the margin of appreciation of hearing panels to reduce, but also aggravate the basic sanction. Since it would be practically impossible to cover all the modifications in one paper, the author analyses four groups of provisions converging in the criterion of fault that he considers the most fundamental novelties in terms of proportionality. The author argues that the new approach towards sanctioning of the ingestion, use or possession of substances of abuse is more suitable and proportionate compared to the one in Code 2015. Moreover, he considers the creation of two new categories of protected persons and recreational athletes and adjustment of their sanctioning a step forward compared to Code 2015 in terms of both suitability and proportionality. On the other hand, the author argues that hearing panels need to consider the difference between cheating and mere knowing to impose a proportionate sanction based on the revised definition of intentional presence, use or attempted use or possession of prohibited substances or methods that abolished the reference to “athletes who cheat”. Moreover, he claims that hearing panels should prefer shorter ineligibility to disqualification of only some competitive results to impose a proportionate punishment in cases involving aggravating circumstances and their combination with the disqualification of results. Overall, the text of Code 2021 is a good start to the race for the proportionality of sanctions. Nevertheless, hearing panels must keep the pace and ensure proportionate punishments in particular cases.

To describe patient characteristics, treatment patterns, and survival among elderly patients (≥66 years) newly diagnosed with acute myeloid leukemia (AML) meeting ≥1 ineligibility criteria for high-intensity chemotherapy (HIC; i.e. age >75 years, cardiac disease/prior anthracycline therapy, or secondary AML), we analyzed 2007-2017 100% Medicare hematologic cancer data. Patients were stratified based on whether they received HIC or low-intensity chemotherapy (LIC) or best supportive care (BSC) within 60 days after AML diagnosis. Of 4,152 patients, 43.2% received chemotherapy, 33.8% BSC, and 23.1% no therapy. Among chemotherapy-treated patients, HIC was more common than LIC (58.8 vs 41.2%), despite targeting patients meeting ≥1 ineligibility criteria for HIC. Poor overall survival was observed for patients receiving chemotherapy and BSC (median overall survival [interquartile range]: HIC, 1.9 [0.8, 6.6] months; LIC, 3.8 [1.4, 9.3] months; BSC, 1.0 [0.4, 2.5] months). Results highlight the need for additional effective and tolerable treatments for this population.

Political rights are fundamental rights. As such, they should be applied to the fullest extent possible. This means that any restriction on political rights must be expressed and take place in accordance with the values contained in the Constitution of the Federative Republic of Brazil. As the hypotheses of ineligibility can only be created by the Federal Constitution and by Complementary Law, Complementary Law 64/90 was published. A hypothesis of ineligibility, however, will be highlighted in this article, that of art. 1?, I, i, of Complementary Law 64/90, on which the question focuses: is this cited hypothesis of restriction on political rights compatible with the Constitution of the Federative Republic of Brazil? Scientific work, through the logical-systematic method and using the analysis of doctrine and jurisprudence. The chapters were divided into an introduction, followed by the discussion about the reconstruction of political rights in the Federal Constitution of 1998, with the constitutional guarantee of the principle of the State of Innocence in the sequence and the deepening of the theme in the fourth chapter entitled unconstitutionality of art. 1?, I, i, of Complementary Law 64/90, in addition to the final considerations. The research concludes pointing to a scenario of unconstitutionality of art. 1?, I, i, of Complementary Law 64/90. Os direitos políticos são direitos fundamentais. Em assim sendo, devem ser aplicados na maior medida possível. Isso significa que qualquer restrição aos direitos políticos deve ser expressa e ocorrer de acordo com os valores contidos na Constituição da República Federativa do Brasil. Como as hipóteses de inelegibilidade só podem ser criadas pela Constituição Federal e por Lei Complementar, foi publicada a Lei Complementar 64/90. Uma hipótese de inelegibilidade, no entanto, será destacada no presente artigo, a do art. 1?, I, i, da Lei Complementar 64/90, sobre a qual incide a questão: é essa hipótese citada de restrição aos direitos políticos compatível com a Constituição da República Federativa do Brasil? O trabalho científico, através do método lógico-sistemático e utilizando-se da análise de doutrina e jurisprudência. Os capítulos foram divididos em introdução, seguido da discussão acerca da reconstrução dos direitos políticos na Constituição Federal de 1998, tendo a garantia constitucional do princípio da Presunção do Estado de Inocência na sequência e o aprofundamento do tema no quarto capítulo intitulado inconstitucionalidade do art. 1?, I, i, da Lei Complementar 64/90, além das considerações finais. A pesquisa conclui sinalizando para um cenário de inconstitucionalidade do art. 1?, I, i, da Lei Complementar 64/90.

Purpose: To evaluate the proportion and reasons for ineligibility to re-register for extended health insurance at 5 years in patients diagnosed with neovascular age-related macular degeneration (AMD) and registered for extended health insurance. Methods: This retrospective study was performed in patients diagnosed with neovascular AMD and registered for extended health insurance with follow-up for at least 5 years. The criteria for re-registration for extended health insurance were determined along with the ineligibility for re-registration. Results: In total, 263 patients were included in the analysis. Of these, 148 (56.3%) did not satisfy the criteria for re-registration. No active treatment was performed in 98 patients during the last 6 months of the study period (no recurrence, 51 patients; additional treatment was not considered beneficial due to retinal damage even without disciform scar formation, 44 patients). Macular disciform scar formation was noted in 50 patients (33.8%). Older age (p = 0.013), poor visual acuity (p = 0.004), and retinal angiomatous proliferation (p < 0.001) were associated with ineligibility for re-registration due to severe retinal damage. Conclusions: Among the patients who were initially registered for extended health insurance, 56.3% failed to satisfy the re-registration criteria. The primary reason was advanced retinal damage. The results of this study provide useful information for patient education and to establish long-term treatment strategies.

Introducción: el uso de sales de platinos en patologías oncológicas es ampliamente usado, una de las preocupaciones de los profesionales de la salud es la presencia de eventos adversos en este grupo de pacientes que suelen ser vulnerables, por lo que es necesario la generación de consensos para realizar una selección óptima de pacientes candidatos a terapias basadas en platinos Objetivo: Realizar un consenso de expertos para la inelegibilidad al uso de platinos de acuerdo a varios criterios para realizar un tratamiento óptimo de acuerdo a la selección y categorización de pacientes Pregunta de salud cubierta por la Guía: ¿Qué pacientes portadores de cáncer de origen otorrinolaringológico no son elegibles para tratamiento con platinos? Población: La población objetivos son pacientes adultos con cáncer otorrinolaringológico. Resultados: Se establecieron consensos para la inelegibilidad al uso de platinos sobre los siguientes criterios: Edad >70 años, ECOG >1, Pérdida involuntaria de peso >20%, función auditiva “borderline”: alteraciones Grado I, Alteraciones neurológicas Grado I, Trastornos de la función renal: CrCL

Objectives In this study we evaluated the clinical characteristics and outcomes of surgically ineligible patients with coronary artery disease (CAD) who underwent multivessel percutaneous coronary intervention (PCI). Background Patients with multivessel CAD who are surgically ineligible and undergo PCI are not well represented in large trials. Methods Out of 1,061 consecutive patients who underwent a non-emergent PCI for unprotected left main or multivessel CAD at the University of Virginia Medical Center, 137 patients were determined to be surgically ineligible for coronary artery bypass graft (CABG) surgery by a heart team. The clinical characteristics and reasons for surgical ineligibility were collected. The coronary angiograms were reviewed and the SYNTAX score calculated. The Society of Thoracic Surgeons (STS) score was calculated. Outcomes were determined at 30 days and 1-year. Results The mean age of the cohort was 71 and 59% were women. Hypertension, hyperlipidemia, tobacco abuse, and diabetes were common comorbidities. The average SYNTAX score was 22. The most commonly cited reasons for surgical ineligibility were advanced age, frailty, severe lung disease, ejection fraction ≤ 30% and STS score ≥ 8%. Outcomes at 30 days were excellent and better than those predicted by STS for surgery. Frailty and STS score predicted one-year outcomes. Conclusions Patients undergoing PCI for multivessel disease who are surgically ineligible have multiple risk factors and comorbidities. Frailty, lung disease, poor left ventricular function, and high STS score represent common reasons for surgical ineligibility. Frailty and the STS score better predict one-year outcomes after PCI compared to the SYNTAX score.

The paper "Mechanisms: Managing Risks of Catastrophic Outcomes" explores a complex system of personal fears that acts as a basic matrix and often a necessary premise for my daily activities. Fear is most often activated by a sentence or a thought What if… The subtitle of the paper also follows from this: "Managing Risks of Catastrophic Outcomes". Through artistic research, three fears were highlighted, to which special attention was paid: fear of death, fear of losing control and fear of failure. Through my artistic work, I explore the complex matrix according to which these fears function, which I present as a spatial installation composed of a total of four mechanisms driven by different electrical devices. Each mechanism individually depicts some of the key themes and concepts related to the aforementioned three fears such as incompatibility, relegation, ineligibility, evasion, isolation, error ...

Objectives: Although the increasing cancer incidence in older patients is widely recognised, older patients remain underrepresented in clinical cancer trials and eHealth studies. The aim of this research is to identify technological and patient-related barriers to inclusion of this population in a clinical eHealth study. Material and Methods: This is a retrospective analysis of a prospective cohort study with older patients (>= 65 years) undergoing cancer-related surgery, who were identified for a perioperative telemonitoring study. Reasons for ineligibility and refusal had been prospectively registered. Characteristics and postoperative outcomes were compared between participants and non-participants. Results: Between May 2018 and March 2020, 151 patients were assessed for eligibility, resulting in 65 participants and 86 non-participants. The main reason for ineligibility was lack of internet access at home (n = 16), while main reasons for refusal were perceived high mental burden (n = 46) and insufficient digital skills (n= 12). Compared with participants, non-participants were significantly older (mean age 75 vs. 73, p = 0.01); more often female (64% vs. 35%, p = 0.00), unmarried (42% vs. 8%, p = 0.01) living alone (38% vs. 19%, p = 0.02); had a higher ASA classification (43% vs. 19%, p = 0.00); often had polypharmacy (67% vs. 43%, p = 0.00); and were more often discharged to skilled nursing facilities (0% vs. 15%, p = 0.00). Conclusion: Our results confirm the underrepresentation of older female patients with little support from a partner and higher comorbidity. We should be aware of technological and patient-related barriers to including older adults with cancer, in order to avoid further dividing patients with low and high digital health literacy. (C) 2020 Elsevier Ltd. All rights reserved.

Submitted by Nadir Basilio (nadirsb@uninove.br) on 2022-06-15T21:06:03Z No. of bitstreams: 1 Cleide Sodré Lourenço.pdf: 999821 bytes, checksum: 97377c98b37180cacd9033e53cd4b17a (MD5) Made available in DSpace on 2022-06-15T21:06:03Z (GMT). No. of bitstreams: 1 Cleide Sodré Lourenço.pdf: 999821 bytes, checksum: 97377c98b37180cacd9033e53cd4b17a (MD5) Previous issue date: 2022-03-24 The study intends to answer the following research problems: Is the TCU accounting process, as it is developed, sufficient to support the adequate judgment of the ineligibility of managers who had their accounts judged irregular by the Electoral Justice? Does the articulation currently existing between the Federal Audit Court and the Electoral Justice, with regard to the decree of ineligibility of managers who had their accounts judged irregular, satisfy the normative parameters of due legal process or does it demand improvement? In light of the constitutional guarantees of the process, the articulated action between these institutions is compatible with the competences of the Courts of Auditors, the competence of the Common Justice to judge actions of improbity and the competence of the Electoral Court to examine the incidence of causes of ineligibility? The hypothesis is that the accounting process system does not seem to allow for the subsidy of sufficient elements for the measurement and determination of the practice of an act of improbity as a requirement for the declaration of ineligibility, even because such an investigation does not seem to be compatible with the constitutional powers of the Courts of Auditors. For that, the deductive methodology was adopted. The purpose of this research is to contribute specifically to the construction of knowledge involving the management accounts process, enabling its improvement with a view to protecting the fundamental rights involved. O estudo pretende responder aos seguintes problemas de pesquisa: O processo de tomada de contas de gestão do TCU, tal como se desenvolve, é suficiente para subsidiar o adequado julgamento da inelegibilidade de gestores que tiveram suas contas julgadas irregulares pela Justiça Eleitoral? A articulação atualmente existente entre o Tribunal de Contas da União e a Justiça Eleitoral, no que respeita à decretação de inelegibilidade de gestores que tiveram suas contas julgadas irregulares, satisfaz os parâmetros normativos do devido processo legal ou demanda aperfeiçoamento? À luz das garantias constitucionais do processo, a atuação articulada entre essas instituições é compatível com as competências próprias das Cortes de Contas, da competência da Justiça Comum para o julgamento de ações de improbidade e da competência da Justiça Eleitoral para o exame da incidência das causas de inelegibilidade? A hipótese é a de que a sistemática do processo de contas parece não dar margem ao subsídio de elementos suficientes para a aferição e apuração da prática de ato de improbidade enquanto requisito para a declaração de inelegibilidade, até porque tal investigação não parece se mostrar compatível com as competências constitucionais dos Tribunais de Contas. Para tanto, adotou- se a metodologia dedutiva. O intuito da presente pesquisa é contribuir especificamente para a construção do conhecimento envolvendo o processo de contas de gestão, possibilitando seu aprimoramento com vistas à proteção dos direitos fundamentais envolvidos, cumprindo o dever de qualificar de forma colaborativa o julgamento da justiça eleitoral.

Purpose Clinical trials are considered the gold standard in evidence-based medicine, yet few patients with cancer ultimately enroll. Here we examine patients screened for thoracic radiation oncology clinical trials to better understand enrollment trends. Methods and Materials A prospective database tracking screening and enrollment for patients referred for thoracic radiation oncology consultation at our institution from 2016 to 2019 was evaluated. Proportional enrollment rates, patient and disease characteristics, self-reported socioeconomic factors, and reasons for ineligibility or nonenrollment across 17 radiation therapy trials were compared. Results Enrollment data on 2372 patients were available for analysis. Of these patients, 40.0% (949) were deemed “not eligible” (NE) for any trial or were unwilling to be further screened. Reasons for ineligibility included stage (44%), histology (13%), radiation therapy not indicated (12%), patient decision (7%), and enrollment in a competing medical or surgical oncology trial (5%). The remaining 60.0% (1423) were “potentially eligible” (PE) for one or more trials. Most had non-small cell lung cancer (71%) or esophageal cancer (16%), and there were significantly fewer stage IV PE (29%) versus NE (49%) patients (P Conclusions Only 12% of patients screened for radiation therapy trials ultimately enrolled, and more than two-thirds had no trial available or were found ineligible. In addition, 19% of potential eligible patients did not enroll because the patient or physician declined. Future trials may benefit from pragmatic designs with more inclusive enrollment criteria and multidisciplinary engagement of referring providers.

In this paper, I argue that hearing panels have the discretion to impose ineligibility for anti-doping rule violations below the limits fixed by Code 2015 or Code 2021, if the otherwise applicable sanction would be excessive and disproportionate in the context of all objective criteria of the case and all subjective elements concerning the athlete or other person. Ideally for legal certainty, WADA should introduce a provision in the Code which would specify conditions of such flexibility to ensure that the pursuit of a proportionate punishment is in balance with other core anti-doping elements. In the absence of such a provision in both Code 2015 and Code 2021, I still believe that hearing panels have the discretion to impose ineligibility below the fixed limits. Code 2015 and Code 2021 limit the sanctioning flexibility of hearing panels by fixing the basic sanctions and their ranges as well as by exhaustive list of options for their elimination, reduction or suspension. Nevertheless, there inevitably were, are and will be cases where the solution contained in Code 2015 or Code 2021 does not work. In such cases, when Code 2015 or Code 2021 do not provide a proportionate sanction, hearing panels should patch such a loophole with general legal principles, including the principle of proportionate punishment. I believe that such sanctioning flexibility of hearing panels does not necessarily compromise the purpose of the Code to fight doping effectively, harmonize sanctions, ensure equality for athletes and other persons, secure legal certainty and other core anti-doping elements. On the contrary, such an approach enables hearing panels to fully adapt sanctions for doping to circumstances of particular cases and to fulfil the internationally recognized general principle of proportionate punishment.

Neoadjuvant chemotherapy has proven clinical benefit in muscle- invasive bladder cancer. Cisplatin is the likely driver of this benefit. Textbook definitions of cisplatin ineligibility may restrict almost 50% of patients from therapy. Checkpoint inhibitors (anti- PD-1 antibodies and anti- CTLA-4 antibodies) are currently in clinical trials for neoadjuvant use. Initial data from these studies appear promising.

The target of this work is on the analysis of the causes of suspension and ineligibility listed by the Complementary Law 135/2010, on its article 26-C, intending to deepen into the concept and the application of the electoral ineligibility of the Brazilian candidates for political positions, manly analyzing the conditions for the terms of office eligibility of the representatives elected by popular vote in our country and its consequences to guarantee the electoral system, through doctrinal and jurisprudential research, especially about the judgment of the Superior Electoral Court - RCAND n. 060090350 - which rejected the candidacy of the former Brazilian President Luis Inacio Lula da Silva in the 2018 Elections, which led to a discussion about the (un)constitutionality of this decision regarding on the application of the Clean Record Law.

O estudo objetiva identificar, a partir da análise do dano ao erário, quais são os fatores ambientais que impactam na probabilidade de gestores municipais serem incluídos na lista de inelegíveis. Para tanto, aplicou-se da técnica de regressão logística em dados de 612 processos de prestação de contas, no período de 2008 a 2016. Os resultados indicaram que os fatores ambientais como distância de um município em relação à Capital e a prestação de contas correspondente ao ano eleitoral impactaram na inelegibilidade de gestores públicos municipais. Desse modo, os municípios localizados em regiões mais distantes da capital, ou seja, menos próximos da sede do Controle Externo, apresentaram maior probabilidade de terem seus gestores incluídos na lista de inelegíveis. Além disso, as prestações de contas de períodos que coincidiram com o ano de realização de eleições municipais evidenciaram ser mais propensas a ter uma maior chance de inelegibilidade dos gestores

Objective The aim: Establish the types of narcological care to be provided at the primary level, develop a functional and organizational model of anti-narcotic activity of general practitioners/ family doctors and an algorithm for its integration at the primary level. Patients and methods Materials and methods: Determination of types of anti-narcotic activity of GPs/family doctors was carried out expertly. The experts were 36 health care providers, doctors and alcohol abusers. The experts evaluated the proposed activities on a 10 point scale: full support - 10 points, and total ineligibility - 0 points. Expert opinion confidentiality saved. The bibliosemantic method and the method of structural-logical analysis were used in the work. The statistical method was used for statistical processing of the obtained results. Results Results: The list of types of medical care is grounded and the functional-organizational model of anti-narcotic activity of general practitioners-family doctors is developed, as well as the algorithm of integration into the primary level of complex anti-narcotic medical care to the population and the motivational mechanisms for the employees of primary level are offered to encourage them to the anti-narcotics activities. Conclusion Conclusions: implementation of the proposed innovations will increase the availability and effectiveness of anti-narcotic activities at the local level.

Objective To estimate the extent of and the reasons for ineligibility in randomized controlled trials (RCTs) of SSc patients included in the EUSTAR database, and to determine the association between patient’s features and generalizability of study results. Methods We searched Clinicaltrials.gov for all records on interventional SSc-RCTs registered from January 2013 to January 2018. Two reviewers selected studies, and information on the main trial features were retrieved. Data from 8046 patients having a visit in the EUSTAR database since 2013 were used to check patient’s eligibility. The proportion of potentially eligible patients per trial, and the risk factors for ineligibility were analysed. Complete-, worst- and best-case analyses were performed. Results Of the 37 RCTs included, 43% were conducted in Europe, 35% were industry-funded, and 87% investigated pharmacological treatments. Ninety-one percent of 8046 patients included could have participated in at least one RCT. In complete-case analysis, the median [range] proportion of eligible patients having the main organ complication targeted by each study was 60% [10–100] in the overall sample of trials, ranging from 50% [32–79] for trials on skin fibrosis to 90% [34–77] for those targeting RP. Among the criteria checked, treatment- and safety-related but not demographic were the main barriers to patient’s recruitment. Older age, absence of RP, and lower mRSS were independently associated with the failure to fulfill criteria for any of the included studies. Conclusions Patient’s representativeness in SSc-RCTs is highly variable and is driven more by treatment- and safety-related rather than demographic criteria.

Dissertation: The Fight against Doping in Sport in Interaction with European Union Law: Proportionality of Ineligibility and Anti-Doping Education Author: JUDr. Jan Exner This dissertation researches the interaction between the fight against doping in sport and the law of the European Union. It particularly analyses whether the World Anti-Doping Agency and other anti-doping organizations respect the proportionality of ineligibility for doping and related role of anti-doping education. The findings of this dissertation demonstrate that anti-doping organizations have crossed the borders of their conditional autonomy and good governance under European Union law through breach of the proportionality of ineligibility in interaction with anti-doping education. In particular, it concludes that they underestimate the role of education as an anti-doping element, which interacts with proportionality of ineligibility. Anti-doping education raises awareness, informs, communicates, instills values, and develops life skills and decision-making capability to prevent intentional and unintentional doping and its consequences, including a potentially disproportionate ineligibility. As such, it also enables the deterrence effect of anti-doping rules and sanctions. On top of that, the level of anti-doping education is...

Background and aims Non-alcoholic fatty liver disease is common and there are a number of treatments in development. Patients with non-alcoholic steatohepatitis (NASH) and significant fibrosis are thought to be the population most in need of treatment. Identification of this group requires liver biopsy. The aim of this study was to identify the proportion of patients screened for phase 2 randomised controlled trials who subsequently entered these studies. Methods Large, multicentre, phase 2 randomised controlled trials of pharmacological therapies for NASH were identified by systematic review. The pooled proportion of potential participants who entered the trials was estimated by meta-analysis. The reasons for trial ineligibility were separately extracted and analysed. Results Thirteen reports of 14 trials were included. Overall, there were 4014 screened individuals included in the quantitative analyses and 53% were subsequently enrolled in a trial. Considering trials in which the entry criteria matched the current paradigm for treatment, that is, the presence of NASH and significant fibrosis, only 35% of screened individuals were eligible for trial entry. More than half of ineligible individuals were excluded on the basis of liver histology most often due to insufficient disease activity with or without insufficient fibrosis. Conclusion The majority of patients considered at risk of NASH and fibrosis sufficient for treatment in randomised controlled trials are ineligible for trial entry. Most often, this is due to ineligible liver histology. These findings have implications for the design of future trials in NASH and for the applicability of treatments after licensing.

Background Antiangiogenic agents have improved the prognosis of non-squamous non-small-cell lung cancers (NSCLCs), even though all the patients are not eligible to receive them because of counterindications linked to the tumor's characteristics or comorbidities. Much less information is available about the eligibility of patients with squamous non-small-cell lung cancers (SQ-NSCLCs) to receive antivascular endothelial growth-factor (VEGF) treatments, even though such molecules are being developed for this histology. This study was undertaken to determine the percentage of advanced SQ-NSCLC patients who would be eligible to receive an antiVEGF agent as second-line systemic therapy. Methods This observational, multicenter, prospective study evaluated advanced SQ-NSCLC patients' criteria for ineligibility to receive an antiVEGF during a multidisciplinary meeting to choose their standard second-line systemic therapy. Results Among the 317 patients included, 53.6% had at least one ineligibility criterion, and ~20% had at least two, with disease extension to large vessels (39.8%), tumor cavitation (20.5%), cardiovascular disease (11%) and/or hemoptysis (7.2%) being the most frequent. Patients with an ECOG performance score of 1/2 had more cardiovascular contraindications that those with scores of 0. Conclusion Almost half of the SQ-NSCLC patients included in this study would have been eligible to receive an antiVEGF agent. The development of these molecules for these indications should be encouraged.

Since the 13th century, there has been a detailed regulation of witness evidence in the legal system. This most certainly arose because of the strong misgivings of the legislator of the time in the light of past experience, when prevailing circumstances forced council authorities to allow all subjective means of evidence to have a greater role. Among these forms of evidence are the testimonies of individuals unconnected to the procedural relationship. What this ultimately demonstrated on many occasions was that their falsehood, a product of a bribe, friendship, enmity, kinship or simple ineptitude, led judges to rule in favour of litigants when in fact they should not have done so

Este estudo tem como objetivo analisar a aplicabilidade da nova redação do artigo 1º, inciso I, alínea “g” dada pela Lei Complementar nº 135/2010 (Lei da Ficha Limpa) à Lei Complementar nº 64/1990 para fins de inelegibilidade por ocasião da rejeição de contas. A pesquisa foi realizada mediante levantamento bibliográfico, legislação e debates suscitados no Supremo Tribunal Federal, onde se ressalta a importância do parecer prévio como instrumento de controle, os pressupostos de inelegibilidade por rejeição de contas e a omissão da Câmara Municipal no julgamento de referidas contas. Conclui-se que o entendimento do Supremo Tribunal Federal atribuindo ao Poder Legislativo Municipal a decisão para fins de inelegibilidade por rejeição de contas mitiga a aplicabilidade do dispositivo sob estudo, já que a Câmara Municipal não possui obrigação de julgar as contas de prefeito. The purpose of this study is to analyze the applicability of the new wording of section 1, bill I, paragraph “g” given by the Complementary Law nº 135/2010 (Clean Record Act) to the Complementary Law nº 64/1990 for ineligibility purposes on occasion of accounts rejection. The research was conducted by means of bibliographic survey, legislation and debates at the Federal Supreme Court, which emphasize the importance of previous opinion as an instrument of control, the assumptions of ineligibility for accounts rejection and omission of the City Council in the judgment of such accounts. It is concluded that the understanding of the Federal Supreme Court attributing to the City Council the decision for the purpose of ineligibility for accounts rejection mitigates the applicability of the studied object, since the City Council has no obligation to judge the mayor’s accounts.

The ultimate goal of COVID-19 vaccination campaigns is to enable the return of societies and economies to a state of normality. While vaccines have been approved for children of age 12 and older, there is an ongoing debate as to whether children should be vaccinated and at what priority, with very different policies being adopted in different countries. In this work, we use mathematical modeling and optimization to study the effect of vaccinating children on the epidemic spread. We consider Pareto-optimal allocations according to competing measures of number of infections and mortality, and systematically study the trade-offs among them. When some weight is given to the number of infections, we find that it is optimal to allocate vaccines to adolescents in age group 10-19, even when they are assumed to be less susceptible than adults. Additionally, we find that in a broad range of scenarios, optimal allocations of vaccines do not include vaccination of age-group 0-9.Author summaryOne of the acute questions public health experts and policymakers currently confront is whether children of age 12 and older, and eventually perhaps younger children, should be vaccinated against COVID-19, and at what priority. Different countries have adopted diverse policies on this issue, while others remain undecided. One of the key considerations in this debate is the impact of children’s vaccination on the epidemic spread. In this work, we use mathematical and computational methods to study this question in a systematic, quantitative way. We compute optimal vaccination allocations, under different criteria for optimality, both including and not including children. To explore tradeoffs among different goals, such as reducing number of infections and reducing mortality, we use the idea of Pareto optimization, which is novel in this field. Our results show that, under a wide range of conditions, optimal vaccine allocations include vaccination of age group 10-19, while the vaccination of age group 0-9 is of lower priority than the vaccination of other age group.

Objective: The democratic principle, the idea of popular sovereignty and the principle of maximum validity of votes are vectors that prevent the voter's expression of will in the ballot box from being completely ignored. Accordingly, votes cast in proportional elections for a candidate who has his candidacy registration rejected must, as a rule, be counted for his party or coalition. This general rule, however, must be adapted so that scams are not encouraged in the electoral process, allowing a well-known candidate who is patently ineligible to run for office only to enable the transfer of votes to the party and the coalition. In order to harmonize the requirement to preserve the voters’ will with the need to prevent fraud in the electoral process, it is necessary that the calculation, for the respective party or coalition, of the votes attributed to the candidate whose registration validity has not been decided on election day, be conditioned to the demonstration of good faith, measured according to objective parameters. In the event that there is no evident ineligibility and the decision to reject the registration issued by an appeals court is made after the deadline for substituting candidates, the voter’s will must be preserved.Methodology: This study is based on the hypothetical-deductive method, by way of research of doctrine, legislation and jurisprudence, through the reading of books, scientific articles and legal diplomas that deal with the topic.Results: The electoral system should work to ensure that the vote given to the candidate who appears in the ballot box is valid. Unfortunately, this is not what has happened in Brazil: voters choose their candidates, but they do not know if their vote will be canceled later due to the definitive recognition of some cause of ineligibility. It is often the complete annulment of votes attributed to candidates – in the proportional election – whose ineligibility (not manifest) was affirmed after the elections. In such cases, the general rule established by the ordinary legislator – which prevents the party from using votes – gives insufficient protection to democratic principles and popular sovereignty.Contributions: The democratic regime imposes a goal (legislative and judicial) of maximum use of the vote, so that its total nullity should be exceptional, applicable as a ultima ratio, only when a situation of fraud to the formation of popular will is configured. This priority of preserving the vote conferred on the party in the proportional system imposes a heavy argumentative burden on the Judiciary in making the decision to completely invalidate the will expressed by the voter. It is necessary to offer very strong reasons to disregard the voter's choice to assign his vote to a given political party in the proportional system. Thus, the general rule of taking advantage of the vote conferred on the political party does not answer, definitively, the question of the destination of the vote received by ineligible candidates in the proportional system. It is necessary to recognize the competence of the electoral justice to weigh the peculiarities of each specific case in order to verify the presence or not of the attempted electoral fraud by submitting a candidacy known to be ineligible in order to distort the formation of the electoral will. Objetivo: El principio democrático, la soberanía popular y el principio de utilización máxima del voto son vectores que impiden que la expresión de voluntad del elector en las urnas sea completamente ignorada. En consecuencia, los votos emitidos en elecciones proporcionales para un candidato cuyo registro de candidatura sea rechazado deben, por regla general, contabilizarse para su partido o coalición. Esta regla general, sin embargo, debe ser adaptada para que no se fomente el fraude en el proceso electoral, permitiendo que un candidato conocido que es claramente inelegible se postule para un cargo solo para permitir la transferencia de votos al partido y la coalición. Para armonizar el requisito de preservar la voluntad del elector con la necesidad de prevenir el fraude en el proceso electoral mediante el lanzamiento de la candidatura de una persona claramente inelegible, es necesario que el cómputo, para el respectivo partido o coalición, de los votos atribuidos al candidato cuya inscripción se encuentre bajo judice el día de las elecciones, estará condicionada a la demostración de buena fe, medida según parámetros objetivos. En el caso de que no exista una inelegibilidad patente y que la decisión de denegar la inscripción otorgada en el segundo grado de jurisdicción se tome fuera de plazo para la sustitución de los candidatos, se debe concluir que se conserva la voluntad del elector.Metodología: El presente estudio se basa en el método hipotético-deductivo, a través de la investigación de doctrina, legislación y jurisprudencia, a través de la lectura de libros, artículos científicos y diplomas jurídicos que abordan el tema.Resultados: El sistema electoral debería funcionar para asegurar que el voto dado al candidato que aparece en las urnas sea válido. Lamentablemente, esto no es lo que ha sucedido en Brasil: los votantes eligen a sus candidatos, pero no saben si su voto será cancelado más adelante por el reconocimiento definitivo de alguna causa de inelegibilidad. Es frecuente la anulación total de los votos atribuidos a candidatos - en la elección proporcional - cuya inelegibilidad (no manifiesta) se afirmó después de las elecciones. En estos casos, la regla general establecida por el legislador ordinario, que impide que el partido utilice los votos, no protege suficientemente los principios democráticos y la soberanía popular.Contribuciones: El régimen democrático impone una meta (legislativa y judicial) de utilización máxima del voto, por lo que su nulidad total debe ser excepcional, aplicable como ultima ratio, solo cuando se configura una situación de fraude a la formación de la voluntad popular. Esta prioridad de preservar el voto conferido al partido en el sistema proporcional impone una pesada carga argumentativa al Poder Judicial para tomar la decisión de invalidar por completo la voluntad expresada por el elector. Es necesario ofrecer razones muy sólidas para ignorar la elección del votante de asignar su voto a un partido político determinado en el sistema proporcional. Así, la regla general de aprovechar el voto otorgado al partido político no responde, de manera definitiva, a la cuestión del destino del voto recibido por los candidatos no elegibles en el sistema proporcional. Es necesario reconocer a la Justicia Electoral la posibilidad de ponderar las peculiaridades de cada caso concreto para verificar la presencia o no de un intento de fraude electoral mediante la presentación de una candidatura conocida como no elegible con el objetivo de desvirtuar la formación de la voluntad electoral. Objetivo: O princípio democrático, a soberania popular e o princípio do máximo aproveitamento do voto são vetores que impedem que a manifestação de vontade do eleitor na urna seja completamente ignorada. Dessa forma, os votos conferidos em eleição proporcional a um candidato que tenha seu registro de candidatura indeferido devem ser, em regra, computados para o seu partido ou coligação. Essa regra geral, porém, deve ser adaptada para que não se estimulem burlas ao processo eleitoral, permitindo-se que “puxador de votos” sabidamente inelegível se candidate a cargo proporcional apenas para viabilizar a transferência de votos para o partido e a coligação. Para harmonizar a exigência de preservação da vontade do eleitor com a necessidade de impedir burlas ao processo eleitoral pelo lançamento de candidatura de pessoa claramente inelegível, é preciso que o cômputo, para o respectivo partido ou coligação, dos votos atribuídos ao candidato cujo registro esteja sub judice no dia da eleição, fique condicionado à demonstração de boa-fé, aferidos de acordo com parâmetros objetivos. Na hipótese de que não haja inelegibilidade patente e de que a decisão de indeferimento do registro proferida em segundo grau de jurisdição se dê após o prazo de substituição das candidaturas, deve-se concluir pela preservação da vontade do eleitor.Metodologia: O presente estudo apoia-se no método hipotético-dedutivo, mediante a pesquisa da doutrina, da legislação e da jurisprudência, por intermédio da leitura de livros, de artigos científicos e dos diplomas legais que tratam sobre o tema.Resultados: O sistema eleitoral deveria funcionar de modo a garantir que o voto dado ao candidato que apareça na urna fosse válido. Infelizmente, não é isso o que tem ocorrido no Brasil: eleitores escolhem seus candidatos, mas não sabem se seu voto será anulado posteriormente em razão do reconhecimento definitivo de alguma causa de inelegibilidade. É frequente a anulação integral de votos atribuídos a candidatos – na eleição proporcional – cuja inelegibilidade (não manifesta) foi afirmada após as eleições. Nesses casos, a regra geral estabelecida pelo legislador ordinário – que impede o aproveitamento dos votos pelo partido – confere proteção insuficiente aos princípios democráticos e à soberania popular.Contribuições: O regime democrático impõe uma meta (legislativa e judicial) de máximo aproveitamento do voto, de modo que a sua anulação integral deverá ser excepcional, aplicável como ultima ratio, apenas quando se configurar situação de fraude à formação da vontade popular. Essa prioridade da preservação do voto conferido ao partido no sistema proporcional impõe ao Poder Judiciário um pesado ônus argumentativo na tomada da decisão de invalidar completamente a vontade manifestada pelo eleitor. É necessário oferecer razões fortíssimas para afastar a escolha do eleitor de atribuir seu voto a determinado partido político no sistema proporcional. Assim, a regra geral de aproveitamento do voto conferido ao partido político não responde, de modo definitivo, à questão do destino do voto recebido por candidatos inelegíveis no sistema proporcional. É preciso reconhecer à Justiça Eleitoral a possibilidade de sopesar as peculiaridades de cada caso concreto a fim de verificar a presença ou não de tentativa de fraude eleitoral pela apresentação de candidatura sabidamente inelegível com objetivo de distorcer a formação da vontade eleitoral.

OBJECTIVES: To examine nutrition benefit under-enrollment in Latinx American immigrant families. METHODS: We administered a survey to 100 adults attending a NY Latinx American community serving organization. We used a logistic regression approach to analyze misinformation impact on enrollment, and examined non-enrollment explanations, among participants in whose families a child or pregnant or breastfeeding woman appeared SNAP- or WIC-eligible. RESULTS: Among households (N=51) with ≥1 SNAP-eligible child, 49% had no child enrolled. Reasons included repercussion fears (e.g. payback obligation, military conscription, college aid ineligibility, child removal, non-citizen family member penalties), and logistical barriers. In multivariable regression models, having heard the rumor that SNAP/WIC participation makes unauthorized status family members vulnerable to being reported to the government was associated with an 85% lower enrollment rate (OR 0.15, CI 0.03, 0.94). CONCLUSIONS: Misinformation impedes nutrition benefit participation. A multi-level intervention is necessary to inform potential applicants and providers regarding eligibility criteria and erroneous rumors, along with an informed discussion of the risks versus benefits of using resources, especially as public charge criteria change.

The process of informed consent in National Institutes of Health randomized, placebo-controlled trials is poorly studied. There are several issues regarding informed consent in emergency neurologic trials, including a shared decision-making process with the patient or a legally authorized representative about overall risks, benefits, and alternative treatments. To evaluate the informed consent process, we collected best and worst informed consent practice information from a National Institutes of Health trial and used this in medical simulation videos to educate investigators at multiple sites to improve the consent process. Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III (CLEAR III) (clinicaltrials.gov, NCT00784134) studied the effect of intraventricular alteplase (n = 251) versus saline (placebo) injections (n = 249) for intraventricular hemorrhage reduction. Reasons for ineligibility (including refusing to consent) for all screen failures were analyzed. The broadcasted presentation outlined best practices for doctor–patient interactions during the consenting process, as well as anecdotal, study-specific reasons for consent refusal. Best and worst consent elements were then incorporated into a simulation video to enhance the informed consent process. This video was disseminated to trial sites as a webinar around the midpoint of the trial to improve the consent process. Pre- and post-intervention consent refusals were compared. During the trial, 10,538 patients were screened for eligibility, of which only three were excluded due to trial timing. Pre-intervention, 77 of 5686 (1.40%) screen eligible patients or their proxies refused consent. Post-intervention, 55 of 4849 (1.10%) refused consent, which was not significantly different from pre-intervention (P = 0.312). The incidence of screen failures was significantly lower post-intervention (P = 0.006), possibly due to several factors for patient exclusion. The informed consent process for prospective randomized trials may be enhanced by studying and refining best practices based on trial-specific plans and patient concerns particular to a study.

BACKGROUND In patients with severe coronary artery disease (CAD) requiring coronary revascularization, the prevalence of surgical ineligibility and its clinical effect on long-term outcomes remain unclear.Methods and Results:Among 15,939 patients with first coronary revascularization in the CREDO-Kyoto percutaneous coronary intervention (PCI)/coronary artery bypass grafting (CABG) registry cohort-2, we identified 3,982 patients with triple-vessel or left main disease (PCI: n=2,188, and CABG: n=1,794). Surgical ineligibility as documented in hospital charts was present in 142 (6.5%) of 2,188 PCI-patients, which was mainly related to comorbidities and advanced age. The cumulative 5-year incidence of the primary outcome measure (all-cause death/myocardial infarction/stroke) was much higher in PCI-patients with surgical ineligibility than in PCI-patients without surgical ineligibility and in CABG-patients (52.5%, 27.6%, and 24.0%, respectively, log-rank P

The present work has focused on relative ineligibility for political positions, after a conviction in the second instance, even without having passed the sentence of condemnation, also considering the principle of presumption of innocence. The hypothetical-deductive method was applied in the elaboration, being based on the doctrinal, jurisprudential and normative construction, as well as bibliographical research through a wide reading of scientific articles, doctrine and jurisprudence. It is concluded at the end that the aforementioned law, although it is a reason for constant discussions in the legal arena, about its constitutionality, it is stated that it is not necessary to speak of unconstitutionality, since our Supreme Court understands that the arrest decreed in court does not violate the principle of the presumption of innocence. Therefore, this rule also applies to political agents, who, after having reaffirmed in second degree the conviction handed down by the court, may be commenced, which in full results in the condition of political ineligibility, implying the victim all negative conditions provided for in Law 135 of 2010.

Data from the National Health and Nutrition Examination Survey (NHANES) have been linked to the Center for Medicare and Medicaid Services' Medicaid Enrollment and Claims Files. As not all survey participants provide sufficient information to be eligible for record linkage, linked data often includes fewer records than the original survey data. This project presents an application of multiple imputation (MI) for handling missing Medicaid/CHIP status due to linkage refusals in linked NHANES-Medicaid data using the linked 1999-2004 NHANES data. By examining multiple outcomes and subgroups among children, the analyses compare the results from a multi-purpose dataset produced from a single MI model to that of individualized MI models. Outcomes examined here include obesity, untreated dental caries, attention deficit hyperactivity disorder (ADHD), and exposure to second hand smoke.

Based on the case study of the Municipality of Valenca do Piaui/PI, this paper aims to analyze the consequences of fictitious female candidacies in a party or coalition. The perspective of the analysis takes into account the difficulty of the case leading case under discussion mainly because it involves the possibility of disqualification of elected candidates, regardless of any involvement in the mentioned fraud. To define consequences for affirmative action that did not come with a control system and whose effectiveness has been built up piecemeal is not an easy task. Far from it. There are countless questions unanswered: i) identified the fraud, what are the consequences of the action? ii) being ineligibility to run, to whom should it be impu- ted? iii) If the term of office of the elected is to be revoked, who shall be removed? iv) If women candidates are elected, considering that they are the recipients of affirma- tive action protection, should their terms be preserved? v) Opting for the disqualification of elected representatives, how should the va- cant seats be fulfilled? By recounting the votes or by holding new elections? The answers to these questions seek to, finally, identify how to make affirmative action effective without opposing more disincentive to the inclusion of women in politics.

People living in Australia on temporary student or work visas are excluded from Medicare access and can face barriers to adequate healthcare, even if they are privately insured. This analysis aimed to quantify this issue in relation to people living with chronic hepatitis B, the majority of whom in Australia were born overseas. The data suggest that an estimated 25 000 people living with chronic hepatitis B in Australia are ineligible for Medicare, 10% of the total number affected, with considerable potential impact in access to effective healthcare and prevention of adverse outcomes.

Background/aim Our study reviewed the results of patients with hepatocellular carcinoma and Child-Pugh score 8-11 cirrhosis treated with stereotactic body radiotherapy when liver transplant was not an option. Patients and methods A retrospective review was performed on 15 patients with Child-Pugh class B and C cirrhosis treated with stereotactic body radiotherapy. The median total dose was 35 Gy in 4-5 fractions. None were listed for a liver transplant due to either being outside of the Milan criteria or to medical contraindications. Results The overall survival was 26.7% at 6 months, with a mean survival of 152 days. The mean survival with and without ascites was 3.3 months and 8.3 months, respectively. Conclusion For hepatocellular carcinoma with cirrhosis of Child-Pugh score 8 or more, prognosis after liver stereotactic body radiotherapy was suboptimal. While irradiation achieved local tumor control, progressive cirrhosis was a common cause of death. Patients without ascites at the time of radiotherapy had the best prognosis.

Objectives Spinal cord stimulation (SCS) is increasingly utilized in the treatment of multiple chronic pain conditions. However, patients will continue to experience other medical issues and the potential for future magnetic resonance imaging (MRI) needs must not be overlooked. SCS devices have device-specific MRI conditional labeling and if impedances are elevated the patient may not be able to obtain an MRI. With 10 kHz SCS devices specifically, an impedance value above 10,000 ohms (Ω) is MRI ineligible. The primary objective of this article was to report the incidence of elevated impedances with a multilumen lead design per electrode, per lead, and to describe the total number of MRI ineligible patients due to elevated impedances using 10 kHz SCS cutoff values. The secondary objective was to determine whether certain patient demographics or surgery characteristics put patients at increased risk of elevated impedances. Materials and methods We performed a retrospective review of 327 patients who were implanted with a 10 kHz SCS device between January 2015 and November 2020. Regression models were fitted to determine associations between MRI ineligibility status with clinical characteristics including age, sex, BMI, lead location, implantable pulse generator (IPG) location, and time since implant. Results We found elevated impedances with subsequent MRI ineligibility in 13 patients (4.0%). Regression analysis did not identify any associations with MRI ineligibility and patient risk factors including age, sex, body mass index, lead location, IPG location, and follow-up time since implant. Conclusion We found the prevalence of elevated impedances above 10,000 Ω to be 4% of implanted patients. This information is important for patients and physicians alike and should be considered when device selection is occurring in the pre-operative visits.

Although the current wide-scale adoption of the HeartMate 3 left ventricular assist device can be attributed to favorable clinical trial outcomes, restrictive clinical trial eligibility criteria may result in lack of generalizability to real-world populations. We assessed the generalizability of left ventricular assist device clinical trial outcomes and evaluated the prognostic value of specific inclusion and exclusion criteria.The Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Therapy With HeartMate 3 (MOMENTUM 3) eligibility criteria were applied to patients identified in The Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) who underwent HeartMate 3 implantation (n = 4610) between August 2017 and March 2020. Patients were categorized as trial-eligible or trial-ineligible and by number of ineligibility criteria. The effect of trial eligibility on mortality was estimated using Cox models.Indications for HeartMate 3 implant included destination therapy (n = 2827, 61%), bridge to candidacy (n = 969, 21%), and bridge to transplant (n = 702, 15%). A total of 1941 recipients (42%) were trial-ineligible, with 1245 (27%) meeting one ineligibility criterion, 470 (10%) meeting two, and 226 (5%) meeting three or more. Estimated 1-year mortality for trial-ineligible recipients was higher than for trial-eligible recipients (17% ± 1% vs 10% ± 1%, P.001). Compared with trial-eligible patients, 1-year mortality was incrementally higher for patients meeting one ineligibility criterion (15% ± 1%), two criteria (16% ± 2%), and three or more criteria (30% ± 3%). Thrombocytopenia and elevated creatinine, bilirubin, and international normalized ratio in trial-ineligible patients were independently associated with increased mortality.Despite differences in mortality, both trial-eligible and trial-ineligible HeartMate 3 recipients had excellent outcomes in real-world practice, suggesting future trial eligibility criteria could be expanded.