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ImportanceMavacamten, a cardiac myosin inhibitor, improved peak oxygen uptake (pVO2) in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM) in the EXPLORER-HCM study. However, the full extent of mavacamten’s effects on exercise performance remains unclear.ObjectiveTo investigate the effect of mavacamten on exercise physiology using cardiopulmonary exercise testing (CPET).Design, Setting, and ParticipantsExploratory analyses of the data from the EXPLORER-HCM study, a randomized, double-blind, placebo-controlled, phase 3 trial that was conducted in 68 cardiovascular centers in 13 countries. In total, 251 patients with symptomatic obstructive HCM were enrolled.InterventionsPatients were randomly assigned in a 1:1 ratio to mavacamten or placebo.Main Outcomes and MeasuresThe following prespecified exploratory cardiovascular and performance parameters were assessed with a standardized treadmill or bicycle ergometer test protocol at baseline and week 30: carbon dioxide output (VCO2), minute ventilation (VE), peak VE/VCO2 ratio, ventilatory efficiency (VE/VCO2 slope), peak respiratory exchange ratio (RER), peak circulatory power, ventilatory power, ventilatory threshold, peak metabolic equivalents (METs), peak exercise time, partial pressure of end-tidal carbon dioxide (PETCO2), and VO2/workload slope.ResultsTwo hundred fifty-one patients were enrolled. The mean (SD) age was 58.5 (11.9) years and 59% of patients were male. There were significant improvements with mavacamten vs placebo in the following peak-exercise CPET parameters: peak VE/VCO2 ratio (least squares [LS] mean difference, −2.2; 95% CI, −3.05 to −1.26; P P P = .001), and peak PETCO2 (LS mean difference, 2.0 mm Hg; 95% CI, 1.12-2.79; P P = .02). There was a significant improvement in nonpeak-exercise CPET parameters, such as VE/VCO2 slope (LS mean difference, −2.6; 95% CI, −3.58 to −1.52; P P Conclusions and RelevanceMavacamten improved a range of CPET parameters beyond pVO2, indicating consistent and broad benefits on maximal exercise capacity. Although improvements in peak-exercise CPET parameters are clinically meaningful, the favorable effects of mavacamten on submaximal exertional tolerance provide further insights into the beneficial impact of mavacamten in patients with obstructive HCM.Trial RegistrationClinicalTrials.gov Identifier: NCT03470545

The subject of the paper is the functioning of Article 79 of the GDPR in the Polish legal system and in other countries. The above provision establishes the right to an effective judicial remedy against a controller or processor, which is to guarantee the protection of personal data in relation to the data subjects. The paper submits to a dogmatic and comparative analysis those regulations that concern the right to an effective legal remedy in the field of personal data protection based on the example of Polish legal regulations, but also with reference to France, Germany and Great Britain to comprehensively study solutions on the issues in question.

Highly specialized methods of selecting participants for clinical trials have been in use for a long time in the medical sciences. An example is offered by oncological pre-profling, which involves the use of genetic biomarkers for a preliminary identification of oncological patients for clinical trials. We should expect further developments in this area, due to the rapid progress being made in e-health technologies and patients’ growing use of mobile applications. Failure to use new technologies in recruitment could even lead to failure in carrying out a clinical trial due to a shortage of participants. This issue is particularly important due to the regulatory framework for profiling adopted under GDPR (the General Data Protection Regulation). GDPR is of crucial importance for the R&D activities pursued by the pharmaceutical industry and in personalized medicine, and one of the biggest challenges is the practical application of its rules in profiling activities. Te same applies to the use of data obtained during clinical trials at the stage when the medical product is about to be launched on the market. The aim of this paper is to present the GDPR rules to facilitate the use of profiling tools for the recruitment of participants for clinical trials. It includes a proposal for the amendment of the EU pharmaceutical law to introduce statutory grounds for profiling.

This research paper analyses legal aspects of the application of modern technologies for practical use in the energy sector in the form of a Smart City. The issue of Smart Environment in the light of renewable energy sources was classified as the main research axis. The main goal of the paper, from the methodological point of view, involves decoding the impact and importance of renewable energy sources for the full implementation of the Smart City concept. First, the article presents introductory remarks regarding the general outline of technical, technological and civilization progress. Then, the essence of the Smart City concept and its pillars have been presented. This permitted the authors to move on to identify the most important legal aspects of the issue discussed in this paper and to search for potential problems and suggest possible solutions. The paper ends with a concise summary containing the authors’ observations on the subject and de lege ferenda postulates.

Tensions related to the presence of religion, its symbols or moral judgments in the public space are noticeable signs in many contemporary societies. Research shows an increasing level of prejudice against believers, which translates into emerging microaggressions. This phenomenon of questioning and hostility towards religion is surprisingly also the case in societies where the majority consists of religious adherents. The aim of this article is to present and analyse the research results on the extent of prejudices and manifestations of hostility towards believers in 2019 in Poland, on a representative sample of respondents. First, the religious situation in Poland will be briefly discussed, in particular the way the Poles experience religious practices. This will be followed by discussion of the most common manifestations of microaggression included in the classification proposed by David R. Hodge, and a legal analysis of the Polish penal system. Finally, we will present a hypothesis regarding the nature of these phenomena and the challenges they represent to religious freedom.

The present studies consider the influence of exclusion on aggressive behavior depending on the target of the aggression and the gender of the aggressor. Previous studies have shown that after exclusion, aggressive behavior occurs toward the excluder as well as toward innocent bystanders. However, there is also evidence that men have a greater tendency toward direct aggression and women have a greater tendency toward displaced aggression. In Studies 1 (N = 89) and 2 (N = 120), participants were ostracized, in Studies 3 (N = 88) and 4 (N = 133), participants were rejected. Then, aggressive behavior toward the excluder or bystander was measured. The results confirmed the gender differences hypothesis, but only in the case of ostracism. After ostracism, more retaliatory aggression was observed in men, and more displaced aggression was noted in women. Rejection resulted in generalized aggressive behavior directed toward the excluder and the bystander in men and women. The results are discussed in light of Sexual Selection Theory.

Titin truncating variants (TTNtv) are known as the leading cause of inherited dilated cardiomyopathy (DCM). Nevertheless, the clinical course is not fully understood and it is unclear whether circulating cardiac biomarkers are helpful in the detection and risk assessment. We sought to assess: 1) early signs of cardiotitinopathy including serum biomarkers: high-sensitivity cardiac troponin T (hs-cTnT) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) in clinically stable patients, and 2) indicators of outcome among TTNtv carriers. Our single-centre cohort included 108 carriers (including 70 DCM patients) from 43 families. Clinical, laboratory and follow-up data were analyzed. The earliest abnormality was left ventricular dysfunction, present in 8, 26 and 47% of patients in the 2nd, 3rd and 4th decade of life, respectively. It was followed by symptoms of heart failure and elevation of NT-proBNP, linked to severe (persistent or transient) left ventricular systolic dysfunction, and later by arrhythmias, preceding both malignant ventricular arrhythmia (MVA) and end-stage heart failure (esHF). Hs-cTnT serum levels were increased in the late stage of the disease only. During the median follow-up of 5.2 years both MVA and esHF occurred in 12% of TTNtv carriers. In multivariable analysis, NT-proBNP level ≥650 pg/ml was the best predictor of both composite endpoint (MVA and esHF), and of MVA alone. We conclude that assessment of circulating cardiac biomarkers is not useful in the detection of cardiotitinopathies but may be helpful in the risk assessment.

Older age and high morbidity of the society contribute to a growing number of patients with cardiac implantable electronic devices (CIEDs) requiring effective cancer treatment, including radiotherapy (RT). The effect of RT on a CIED may vary depending on the type and physical parameters of radiation, location of the treated lesion, indications for electrotherapy, and the type of CIED. In the most dramatic scenarios, it may cause an irreversible damage to the CIED, with serious clinical consequences. The lack of precise guidelines may limit the access to RT for many patients with CIEDs who would otherwise benefit from the therapy or may lead to a therapy without taking the necessary precautions, which may worsen the prognosis. Therefore, clear and unequivocal recommendations for assessing patient eligibility for RT are aimed at ensuring that adequate precautions are taken as well as at providing patients with concomitant cardiovascular and oncologic diseases with access to safe and effective RT.

This paper discusses the judicial dialogue between the European Court of Human Rights and the Court of Justice of the European Union regarding the placing of hyperlinks on the internet. Firstly, the case law of the CJEU in the light of the linkage is analysed. This shows the scope of restrictions created by this judicial authority in the area of copyright. Secondly, the judgment of the ECHR will be cited and analysed as regards the relationship between placing hyperlinks on the internet and freedom of expression. There is a judicial dialogue with the CJEU, which focuses attention on the human rights aspect of hyperlinks. Thirdly, the correlation between the jurisprudence of the CJEU and the ECHR will be analysed, including a functional interpretation. The paper ends with a discussion about the potential of this judicial dialogue for the wider purpose of building an optimal model for European dialogue.

This paper discusses issues relating to the possibility of implementing telemedicine solutions within the framework of the Polish healthcare system financed from public funds. Firstly, as part of introductory remarks, an outline of technical, technological and civilizational progress, as well as its correlation with the law and social behaviours is made. Secondly, due to the lack of a legal definition of e-health, the definitions proposed in literature and created by selected international and non-governmental organizations are recalled. In this way the essence of this concept is revealed. Thirdly, based on relevant international documents, the overall potential of e-health is presented. This shows the various benefits that the use of avant-garde solutions within the healthcare system can bring. Fourthly, a catalogue of the possible barriers to the deployment of e-health solutions is presented. From the presentation, it becomes clear that such processes will not run seamlessly. Fifthly, an outline of the right to healthcare is provided on the basis of instruments of national and international law, indicating the most important elements of the right. Sixthly, a forecast of the demand for telemedicine services in Poland is presented. Seventhly, the sociological concept of the so-called digital exclusion is introduced and the occurrence of this phenomenon in the Polish society is discussed. The paper ends with a brief summary, in which the author considers all the arguments presented and offers his own position and de lege ferenda proposals for the Polish legislator.