Relevant Competent Authorities Research Articles

Assessment of the dynamics of the quality of life of the population of the Kulundinsky district of the Altai Territory

The article deals with the topical issue of the quality of life of the rural population on the example of the Kulundinsky district of the Altai Territory. The methodology of quality of life research is based on structural functionalism and symbolic interactionism. The study of the quality of life was carried out by both qualitative and quantitative methods, and the components of the quality of life themselves were based on both objective and subjective levels. Methods such as a questionnaire survey of the population, an expert survey in the form of an in-depth interview, a focus group, and document analysis were used in the work. This article presents the results of a sociological study in the period from 2022 to 2023, which allows you to track the small dynamics of the quality of life of the rural population, to detect real changes associated with objective and subjective parameters. The novelty of the study lies in a comprehensive assessment of the dynamics of the quality of life of the rural population of a particular municipality, which allows us to study the issues of the quality of life of the population at a deep level, both at the empirical level and at the level of theoretical generalizations. The results of the sociological research showed that a number of objective components of the quality of life have noticeably increased compared to the previous year, as for the subjective component, we can also state some improvement, since the population feels real care about itself in the person of the district administration, village councils and the government of the region. Special attention should be paid to the need to extrapolate the methodology of this sociological study to other areas of the Altai Territory, which allows the relevant competent authority to track point-defined problems and promptly resolve them.

STATE REGISTRY OF HUMAN GENOMIC INFORMATION IN UKRAINE: HOW TO ACHIEVE A BALANCE BETWEEN LAW, MEDICINE AND ETHICS.

The aim: The purpose of this study is to analyze the provisions of the Law of Ukraine "On State Registration of Human Genomic Information" and to make proposals for its improvement taking into account international experience. Materials and methods: The study was conducted on the basis of the analysis of normative material, investigative and judicial practice, decisions of the ECtHR, the position of experts involved in the process of identification of deceased persons, which was expressed during the Second All-Ukrainian Forum of Forensic Experts on June 17, 2022, and a working meeting of the leadership of the KNDISE, DSU "Main Bureau of Forensic Medical Examination of the Ministry of Health of Ukraine" with a representative of the European Training Center for Identification of Victims of Natural Disasters and Forensic Examination in Central Europe (ETAF) (Germany). Conclusions: The Law of Ukraine «On the State Register of Human Genomic Information» is a progressive step towards normalizing the use of DNA analysis as an evidence tool. The detailed regulation of the types of information and subjects subject to DNA testing, taking into account the procedural status of the person, the gravity of the crime or official duties, fully complies with international standards. At the same time, the issue of legal certainty and compliance with the principle of confidentiality requires additional elaboration, since the provision of genomic information obtained in accordance with this law to the authorities of foreign states is possible only if these authorities and the relevant competent authority of Ukraine can establish such a regime of access to infor¬mation that makes it impossible disclosure of information for other purposes or its disclosure in any way, including through unauthorized access. The procedure for selecting, storing, and using genomic information and enshrining it in this law requires unification, as the extensive departmental approach creates risks for the quality of the law, improper use of information, and minimizes the guarantee of its protection.

TACTI-003: A randomized phase IIb study of eftilagimod alpha (soluble LAG-3 protein) and pembrolizumab as first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma.

TPS6099 Background: Eftilagimod alpha (efti) is a soluble LAG-3 protein targeting a subset of MHC class II molecules that mediate antigen presenting cell (APC) and CD8 T-cell activation. Data from a non-randomized, phase II trial of efti plus pembrolizumab (TACTI-002) showed encouraging antitumor activity and manageable safety when given as second-line treatment of patients with recurrent or metastatic head and neck squamous-cell carcinoma (RM-HNSCC). TACTI-003 (NCT04811027) is a multicenter, open label, randomized phase IIb trial to investigate efti plus pembrolizumab in the first-line setting for RM-HNSCC. Methods: A total of 154 patients (pts) are currently being recruited into two cohorts (A+B). In cohort A, pts with tumors that are CPS≥1 will be randomly assigned 1:1 to receive either efti (30 mg subcutaneously Q2W for initial 6 months, thereafter Q3W) plus pembrolizumab (400 mg intravenously Q6W) for up to two years or pembrolizumab alone. Randomization will be stratified by CPS (1-19 vs. ≥ 20) and ECOG PS (0 vs. 1). Pts with tumors that are CPS < 1 will receive efti plus pembrolizumab (cohort B). Imaging will be performed every 9 weeks. The primary endpoint (EP) is objective response rate (ORR) by RECIST1.1. Secondary EPs include overall survival, ORR according to iRECIST, time to and duration of response, disease control rate, progression-free survival, occurrence of anti-efti -specific antibodies, safety, and quality of life. Exploratory endpoints comprise biomarkers. The study has been approved by relevant competent authorities, ethic committees and IRBs. Clinical trial information: NCT04811027.

Problems and Prospects of Cross-Border Cooperation Between Russia and Kazakhstan

The purpose of the article is to analyze the directions of cross-border cooperation between Russia and Kazakhstan, identify problems and prospects for its development. The subject of the research is the socio-economic relations arising in the process of cross-border cooperation between Russia and Kazakhstan. The object of the research was the border regions of Russia and Kazakhstan. The research methodology is based on the application of an institutional approach to the study of cross-border cooperation of the countries under consideration. The information base of the study was made up of data from the Federal State Statistics Service of the Russian Federation and the Bureau of National Statistics of the Agency for Strategic Planning and Reforms of the Republic of Kazakhstan, regional and national regulations characterizing cross-border cooperation of the analyzed countries. The results of the study represent a comprehensive assessment of the development of cross-border cooperation and recommendations for eliminating barriers to the development of cross-border cooperation in general. The scientific value of the work lies in a comprehensive understanding of the existing integration mechanisms in the border areas of Russia and Kazakhstan. The practical value of the work lies in the fact that the conclusions of the study may be of interest to the circle of persons engaged in scientific study of the development of cross-border cooperation between Russia and Kazakhstan, as well as for specialists of the relevant competent authorities of these countries.

CURRENT ISSUES OF THE REPRESENTATION OF THE STATE PROSECUTOR'S INTERESTS IN COURT

The article is devoted to the grounds for representing the interests of the state in court by the prosecutor. Since 2016, as a result of the implementation of constitutional reform in the field of justice, the prosecutor's office represents the interests of the state in the courts in exceptional cases and in the manner prescribed by law. The issue of representation by the prosecutor's office has recently become increasingly important, as both the number of legal disputes and the lack of protection of state interests by the relevant competent authorities are growing. Issues of a practical nature related to the implementation of this constitutional function of the prosecutor's office are becoming more and more acute, including different interpretations of "exceptional cases of representation", "public interest", "authorized subject of power" ", Which are key to establishing the existence of grounds for the prosecutor to represent the interests of the state in court. The analysis of such concepts as "exceptional cases", "inaction" of the competent authority (to protect the interests of the state), "failure to protect", "improper protection". Emphasis is placed on the fact that in case of non-exercise or improper exercise by a state authority, local government or other subject of power, which is responsible for the relevant powers, protection of state interests, as well as signs of administrative or criminal offenses. nature, if there are grounds, the prosecutor must perform the actions provided by law to initiate the relevant proceedings. All this leads to the fact that the possibility of representation of the interests of the state in court by the prosecutor increasingly acquires elements of "exclusive representation of the interests of the state in court by the prosecutor".

440 A Phase II study of eftilagimod alpha (soluble LAG-3 protein) and pembrolizumab in patients unselected for PD-L1 expression in first line metastatic head and neck squamous cell carcinoma (HNSCC)

BackgroundEftilagimod alpha (efti) is a soluble LAG-3 protein targeting a subset of MHC class II molecules, effectively mediating antigen presenting cell (APC) and CD8 T-cell activation. Interim data from a phase II trial of efti plus pembrolizumab (TACTI-002) showed encouraging antitumor activity and manageable safety in patients treated for second line metastatic head and neck squamous cell carcinoma (HNSCC). TACTI-003 (NCT04811027) is the multicenter, open label, randomized phase II trial to investigate efti plus pembrolizumab in the first line setting for HNSCC patients.MethodsA planned total of 154 patients (pts), unselected for PD-L1 expression, will be recruited into two cohorts (figure 1). In cohort A, CPS≥1 pts will be randomly assigned 1:1 to receive either efti (30 mg subcutaneously Q2W for initial 6 months, thereafter Q3W for up to 2 years) plus pembrolizumab (400 mg intravenously Q6W for up to two years) or pembrolizumab alone. CPS will be stratified (1–19 vs. ≥ 20 and ECOG 0 vs. 1). Cohort B will include pts with CPS<1 who will receive efti plus pembrolizumab without randomization. Imaging will be performed every 9 weeks. The primary end point (EP) is objective response rate (ORR) by RECIST1.1. Secondary EPs include overall survival, ORR according to iRECIST, time to and duration of response, disease control rate, progression free survival, occurrence of anti-efti -specific antibodies, safety, and quality of life. Exploratory endpoints comprise biomarkers. The study has been approved by relevant competent authorities, ethic committees and IRBs.Abstarct 440 Figure 1Trial designTrial RegistrationNCT04811027Ethics ApprovalThe study was approved by relevant ethic committees and institutional review boards.

Analysis on the health status of radiation workers in an international airport

Objective: To understand the occupational health status of radiation workers at an international airport, and to provide basis and reference for relevant competent authorities to conduct scientific and effective occupational health monitoring. Methods: From July to August 2019, 246 radiation workers at an international airport were selected as the research subjects (observation group) , and their occupational health examination data were collected. At the same time, 210 radiation workers from a medical institution were selected as the control group. The occupational health examination results of the two groups were compared. And the differences in occupational health examination results of airport radiation workers among difference service age were analyzed. Results: Compared with the control group, the detection rates of ocular lens opacity (1.63%, 4/246) and abnormal blood glucose (4.07%, 10/246) in the observation group were lower, the detection rates of abnormal skin (11.79%, 29/246) , abnormal B-ultrasound of liver, gallbladder and spleen (75.61%, 186/246) and abnormal chest X-ray (5.28%, 13/246) were higher (P<0.05) . There were significant differences in the abnormal detection rates of skin, blood glucose, B-ultrasound of liver, gallbladder and spleen among airport radiation workers with different service age (P<0.05) . Abnormal chromosome of peripheral blood lymphocytes, abnormal chest X-ray were mainly distributed in the service age of ≥20 years. The abnormal rate of B-ultrasound of liver, gallbladder and spleen was higher in different working age groups. Conclusion: Long term low-dose irradiation will have a certain impact on the occupational health of airport radiation workers. The occupational health monitoring of relevant personnel should be strengthened to protect their occupational health.

Build up circular city planning index with EAM

This study is aimed to build up a structure of circular city planning index with Essential Analysis Model (EAM). As countries around the world are engaged in finding solutions against increasingly exhausting resources and energies, the circular city is trending the metro development in future. This mandates a structure for index in circular city planning in future. To ensure the practice of the structure, it is to be based on circular economy and derived by “target oriented” essence logic. This study employs semi-structured exert interview to get professional inputs from more comprehensive population. A hierarchical structure of 18 major and 53 minor indexes is set up with the help of mind map software which may be referenced by government agencies, metro governance, urban and rural planning, and relevant competent authority in their circular city planning endeavor.

Establishing the Criteria for the Quality of Elderly Medical Care From the Multiple Perspectives

In 1993, Taiwan has transformed into an aged society. Compared with general patients, older patients differ considerably in body functionality, mentally, and mobility-wise. The primary customers of medical institutions are adult patients in Taiwan, and the needs of older patients are often ignored; however, older patients visiting the case hospital in this study accounted for nearly 30% of the total number of outpatients. This indicates that the needs of older patients are a matter requiring the serious attention of medical personnel. This is a common issue for all countries that were entered an aging structure of the population. This study investigated the attention paid by supervisors and medical personnel involved with medical decisions to the quality of medical services received by older outpatients. An analytic hierarchy process (AHP) was employed to interview 10 experts in older medical care providing age-friendly medical care at the case hospital, medical staff including senior physicians, nursing department supervisors, administration department supervisors, and certified managers. The results indicate that the supervisors and medical personnel considered the “communication and services” provided to older patients during their medical treatments to be the most crucial factor in their treatment process, rating it twice as important as the next most important criteria, the care process and physical environment. Medical personnel paid great attention to communicate with and servicing older patients; listening to their needs and concerns was deemed the most critical, followed by being able to empathize with them to solve problems. Asking patients about their problems when they visited the hospital was considered the most crucial aspect of the care process; in the physical environment, it was spatial planning and traffic flow design. The results of this study enable other countries' medical institution managers and relevant competent authorities to gain insight into the attention paid by front-line employees in promoting age-friendly medical care. If supervisors and medical personnel involved with medical decisions share a similar attitude toward promoting medical service quality, government authorities and medical institutions can implement and enhance an age-friendly medical treatment environment for older patients, as well as increase quality of patient-centered medical services.

Short-term Prediction of Power Consumption for Large-scale Public Buildings based on Regression Algorithm

Energy consumption monitoring and regulation on large-scale public buildings are always an indispensable part in building energy conservation. With the mounting establishment of the building sub-metering platform, massive amounts of historical power consumption data are provided. In this paper, different building types of six large-scale public buildings in Shanghai are selected, with their sub-metering data deeply analyzed. The concept of CDHs/HDHs (cooling/heating degree hours) is introduced and weekly prediction models of total building power consumption are proposed by the way of multiple linear regression algorithm which is relatively simple and easy to understand. The prediction models are validated to have great accuracy and general applicability in the paper, offering reliable instructions to the building facility manager and relevant competent authorities in terms of decision making and policy implementation.

Summary of: Over-the-counter (OTC) bruxism splints available on the Internet.

Background Some individuals may now be bypassing their dentists for treatment of bruxism. Self-diagnosed, self-adjusted and self-monitored consumers can access over-the-counter (OTC) bruxism splints via the Internet. While some may regard this market as benefiting consumers there are potential pitfalls that need to be highlighted. These include unevidenced claims of efficacy. Objective To survey OTC bruxism splints available to individuals in the UK via the Internet, categorise their characteristics, and determine any web-based claims or safety warnings. Materials and methods An Internet search was made of OTC bruxism splints available in the UK. The following information was recorded for each OTC splint: the name of the manufacturer, name of the device, its UK price and any claims and safety warnings made either on a major UK retail website or via other UK web retail outlets. In addition, a note was made of any web-based mention of 'CE marking', indicating compliance with the EC Medical Devices Directive's requirements for safety, quality and performance. Results Safety information is notable for its paucity and is totally lacking on many Internet sites. However, manufacturers are not obliged to display safety information on the Internet, but it must be provided with the product. A search of the MAUDE database showed a number of potentially serious adverse events associated with these splints including choking hazards, tissue damage and occlusal changes. None of the splint designs assure full occlusal coverage. Conclusions As with any partial coverage appliance, if worn for protracted periods there may be a risk of unwanted tooth movement. Dentists should report or assist patients with reporting suspected adverse events with OTC splints to the relevant competent authority. In the UK this is the Medicines and Healthcare Products Regulatory Agency (MHRA).

Over-the-counter (OTC) bruxism splints available on the Internet

Some individuals may now be bypassing their dentists for treatment of bruxism. Self-diagnosed, self-adjusted and self-monitored consumers can access over-the-counter (OTC) bruxism splints via the Internet. While some may regard this market as benefiting consumers there are potential pitfalls that need to be highlighted. These include unevidenced claims of efficacy. To survey OTC bruxism splints available to individuals in the UK via the Internet, categorise their characteristics, and determine any web-based claims or safety warnings. An Internet search was made of OTC bruxism splints available in the UK. The following information was recorded for each OTC splint: the name of the manufacturer, name of the device, its UK price and any claims and safety warnings made either on a major UK retail website or via other UK web retail outlets. In addition, a note was made of any web-based mention of 'CE marking', indicating compliance with the EC Medical Devices Directive's requirements for safety, quality and performance. Safety information is notable for its paucity and is totally lacking on many Internet sites. However, manufacturers are not obliged to display safety information on the Internet, but it must be provided with the product. A search of the MAUDE database showed a number of potentially serious adverse events associated with these splints including choking hazards, tissue damage and occlusal changes. None of the splint designs assure full occlusal coverage. As with any partial coverage appliance, if worn for protracted periods there may be a risk of unwanted tooth movement. Dentists should report or assist patients with reporting suspected adverse events with OTC splints to the relevant competent authority. In the UK this is the Medicines and Healthcare Products Regulatory Agency (MHRA).

Influenza vaccine strains: Licensing perspectives

Influenza vaccine strains: Licensing perspectives

Key Site Abandonment Steps in CO2 Storage

The European Commission published a set of Guidance Documents to assist countries and stakeholders to implement the EU Directive 2009/31/EC on geological storage of CO2. The main objectives of the CO2CARE project are closely linked to the three high-level requirements of the Directive with regard to post-closure transfer of liability of a storage site to the relevant competent authority: (i) absence of any detectable leakage, (ii) conformity of actual behaviour of the injected CO2 with the modelled behaviour, and (iii) the storage site is evolving towards a situation of long-term stability. Guidelines for regulatory compliance and “Best Practice” for site abandonment are being established by distillation and integration of all research findings into site closure and abandonment protocols. The work is based on 9 key injection sites in Europe and worldwide.

The frail person and his caregiver: cure, care or simultaneous care? A conceptual article

The greatest challenge we face over the next 20 years is the management of chronic diseases in an elderly population. Older adults in poor health are at risk of negative outcomes and are the major consumers of health resources in hospital or in community settings. As a consequence, the medical, social and organizational solutions for frail people with chronic disease must resolve a complex situation. The caregiver is a key to the care of the frail patient with chronic diseases, acting both as point of reference and support giver. The caregiver inside the family is becoming increasingly both the supplier of care as well as the subject of that care with its matrix of important physical, psychological, relational and working consequences. The aim of the present article is to focus on the cultural and organizational pillars of guaranteeing care and assistance as well as to consider as a whole both the frail patient and their caregiver. The chronic patient almost always has some disability because of his or her history of clinical complexity, with several comorbidities and social fragility. Such a patient requires a multidisciplinary approach and at the same time needs an individualized of care in order to optimize his or her physical and clinic condition, quality of life and social involvement. Therefore, the patient’s need is not only clinical but also social and multifaceted. Continuity of care is inevitably the solution for the frail patient. This would be based on an integrated net of services including hospitals for acute admissions, intermediary structures, centers of rehabilitation and long-term admission, homecare and primary care services all working with real dialogue, communication and integration. A general consensus on which follow-up program can be most effective for chronic patients is still lacking. The most important function for good continuity of care is what is technically called “case management”, which is the ability to activate all the necessary resources to deal with the various different needs of the individual patient. Continuity is founded on two poles: on the one hand patient care from local general practitioners and home-care services and on the other hand hospital admission or out-patient services for specific diseases. To ‘network’ means to think of the projects in terms of “Hub and Spokes” with centralized expertise that spreads and branches to the regions. To ‘guarantee continuity’ means to integrate social services in local areas and other relevant competent authorities using methodologies of empowerment and development of expertise. In preparing the guidelines, it is essential to think about the whole process of patient care as a virtuous circle of listening, planning, programming and verification in the field. Guarantee of continuity of care should be a fundamental contractual principle both for the one who pays and for the one who disburses the service. However, it is not enough to only treat the specific illness; there is a need to take into account not only the symptoms of this illness but also the medical complexity of other factors involving the whole person. An organizational answer is not enough to bridge this gap; formative education both in university and school is needed. Indeed, a culture is needed that changes the physicians’ focus on patients as individual person within the population that focuses on his holistic care. The future of chronic and frailty care follow-up systems depends on: (1) human factors, (2) economics and (3) technology. The real “technology” is the human resource available in hospitals, homes and health and social care organizations. New care models need to respond to criteria of equity, simplicity, efficiency, efficacy, safety and patient-centeredness.

Determining the Validity of Arbitration Agreements in China: Towards a New Approach

How to determine the validity of foreign-related arbitration agreements in China remains a hot issue in China in recent years, which covers mainly two topics: who and which law will determine such a question. This article analyses the relevant competent authorities and the conflict rules in determining such a question under the current Chinese legal framework. The author first points out the problems existed in the jurisdiction and conflict rules in determining the validity of arbitration agreements, then examines the deficiencies in the stipulation about the validity of an arbitration agreement in China's Arbitration Law. Based on the analysis, the author suggest that for the sound development of the international commercial arbitration in China, the number and competence of the courts to determine the validity of arbitration agreements be limited; the arbitrail institutions be given priority in determining such an issue when arbitration takes place in China; the conflict rules be drafted in accordance with those contained in the 1958 New York Convention and the opportunity of the application of the lex fori ( the Chinese law) be reduced; when the Chinese law is applicable to the determine the validity of arbitration agreements, the Chinese courts adopt the liberal interpretation instead of the restrictive one. For the long run, the Arbitration Law had better be amended, the competence/competence principle should be completely adopted, the stipulation on the designating of the arbitrail institutions should be deleted, and the party autonomy should be fully respected.

Occupational health legislation and practices related to seafarers on passenger ships focused on communicable diseases: results from a European cross-sectional study (EU SHIPSAN PROJECT)

BackgroundSeafarers play an important role in the transmission of communicable diseases. The aim of the present study is to draw information and identify possible gaps on occupational health practices related to seafarers sailing on ships within the European Union Member States (EU MS) with focus on communicable diseases.MethodsA structured questionnaire was sent to competent authorities from 21 EU MS. The questionnaire included questions about occupational health policies, medical certification of seafarers, communicable diseases reporting and relevant legislation. Descriptive analysis of the data was conducted by the use of Epi Info software: EU MS were categorized in four priority groups (A, B, C, D) based on: number of passenger ships visits, volume of passengers, and number of ports in each country. Moreover, EU MS were categorized to old and new, based on the date of entry in the EU.ResultsAll 21 countries with relevant competent authorities responded to the questionnaire. The existence of specific national legislation/regulation/guidelines related to vaccination of seafarers was reported by three out of the 21 (14%) responding authorities. Surveillance data of communicable diseases related to seafarers are collected and analyzed by 4 (19%) authorities. Five out of 21 of the responding countries (24%) reported that tuberculin test result is required for the issuance of seafarer's medical certificate while a great variety of medical examination is required for the issuance of this certificate among countries.Gaps on occupational health services focused on communicable diseases related to maritime occupation have been reported by 33% of the responding countries.Responding authorities from Group A and B had the highest percentage of reported gaps followed by groups C and D. Old MS reported a higher frequency regarding gaps on occupational health services in comparison to new MS.ConclusionOur results revealed heterogeneity regarding occupational health of maritime employees in EU MS. This work provides some evidence that further work at international and European level could be considered, in order to explore the potential for harmonized initiatives regarding occupational health of seafarers.

Planning and Approval of Large Scale Infrastructure Projects in Germany

AbstractThe planning and approval of large-scale infrastructure projects in Germany follows - in general - the rules and regulations of a planning approval procedure according to the administrative procedure laws and the respective specialised planning law. The planning approval decision is a discretionary decision of the relevant competent authority. It integrates all necessary permits with respect to the project applied for. Therefore, the planning procedure is highly complex and sometimes extremely time-consuming. In exchange, the planning approval decision offers a high degree of legal certainty generally including the right of expropriation.