Central Committee Research Articles

295. SAFETY OF SURVEILLANCE GASTROSCOPY AND ENDOSCOPIC ULTRASONOGRAPHY IN THE OESOPHAGUS AFTER NEOADJUVANT CHEMORADIOTHERAPY: RESULTS FROM THE SANO COHORT

Abstract Background An organ sparing strategy has been proposed for patients with oesophageal cancer and a clinically complete response after neoadjuvant chemoradiotherapy (nCRT). This active surveillance strategy involves (repeated) oesophagogastroduodenoscopy (OGD) with bite-on-bite biopsies and endoscopic ultrasonography (EUS). The preSANO trial and preliminary results of the SANO trial concluded that these procedures are safe to identify those with a clinically complete response. However, the safety of these procedures beyond that timeframe remains unknown. The aim of this study is to assess the safety of endoscopic procedures after nCRT, extending beyond three months. Methods This is a retrospective multicentre cohort study. All patients who participated in the pre-SANO and SANO studies were included. All were treated with CROSS nCRT for oesophageal cancer and underwent (repeated) endoscopic response evaluations (OGD with bite-on-bite biopsies and/or EUS with fine needle aspiration, as indicated). Primary outcome was serious adverse events (SAE) as defined by Central Committee on Research Involving Human Subjects (CCMO) associated with endoscopic procedures which include (but are not limited to) bleeding, infection and perforation. Secondary outcome included mechanical injury. Results A total of 919 patients underwent at least one endoscopic response evaluation. Some 2355 endoscopic procedures (61% OGD with EUS combined, 33% OGD and 6% EUS) were performed. Of these, 819 (35%) were performed more than three months after nCRT. SAEs were reported for five endoscopic procedures (0.2%) and included three cases of gastrointestinal bleeding after OGD with biopsies and two cases with infection secondary to the endoscopic procedures. No significant difference in SAEs was found between the procedures conducted before and more than three months after nCRT (2 vs. 3, OR 2.8, 95% CI, 0.3 – 33.7, P = 0.35). Conclusion OGD with biopsies and EUS are both procedures which can be safely performed after nCRT during an active surveillance strategy.

THE STORY “ZINDAN” BY GAYAZ ISKHAKI IN THE LITERARY CONTEXT OF THE EPOCH

The classic of Tatar literature Gayaz Iskhaki was born in Kutlushkino (Yaushirma) village of Chistopolsky district in the family of a famous mullah who engaged in education and charity. First, he received knowledge, love for books and reading from parents and maternal grandmother and later in the day school of the village. He continued his studies in a famous in the Muslim world of Russia and the countries of the East madrasah of Zakir Kamalov, which not only produced future imams, hazrats, but also teachers for other madrasahs. This period of his life spent in Chistopolsky district laid the foundation for the worldview of the future writer and thinker and played an important role in shaping the personality of G. Ishaki. It was there, in the Chistopolsky prison, that the autobiographical novel "Zindan" was written, which testifies to his passion for revolutionary ideas and reflects the real facts from the life of the Chistopolsky prison. The autobiographical work "Zindan" is based on real events and provided with various historical and cultural facts and details from the literary life of the epoch. The text reflects the perception of current events by the writer who was the witness and an active participant in them. The novel "Zindan" was published in a separate edition in Kazan in 1907. Due to the humanity of the censor N.F. Katanov, the book was not confiscated and criminal prosecution against the author was not initiated. The interest of the Central Committee of Foreign Censorship of St. Petersburg manifested in 1908 in relation to the work of G. Iskhaki led to a thorough examination of the content of "Zindan" by another member of the Kazan Provisional Committee for Press Affairs N.I. Ashmarin in order to search for places with signs of "crimes". His review led to the decision of the Committee to seize Iskhaki's pamphlet "Zindan" because of the illegal content, bringing the author to criminal responsibility under the article 129 of the Criminal Code. The author of the article summarized the material on the period from the biography of G. Iskhaki spent in Chistopolsky district and revealed the great work of the scientific community of Tatarstan to return its literary heritage to the history of Tatar literature of the twentieth century. The interpretation of the story "Zindan" by various literary critics in the historical, cultural and literary context of the epoch showed that the story "Zindan" in the form of a prison chronicle introduced new ideological and thematic tones into Tatar literature and gave impetus to the rapid development of the autobiographical genre in Tatar literature being of high value as a historical source.

On the Historical Lessons of Reform and Opening-Up

The reform and opening-up initiative has left us with many valuable historical lessons. This paper mainly discusses the historical background of reform and opening-up, Deng Xiaoping Theory, historical lessons, and explores the reform and opening-up in the new era, in light of the decisions made at the Third Plenary Session of the 20th CPC Central Committee. Comprehensive deepening of reform in the new era must adhere to the principle of upholding the Party's overall leadership and the people-centered approach. While focusing on promoting economic system reform, it is essential to coordinate and plan reforms in other fields to fully advance the great rejuvenation of the Chinese nation through Chinese-style modernization.

Exploring genesis and praxis of restorative justice in Saskatchewan, Canada

ABSTRACT This study explores the growth and development of restorative justice in Saskatchewan. With key informant interviews and surveys, this study finds that government officials and the community played an important role in the growth of restorative justice (RJ) in Saskatchewan. The data are analyzed with NVivo 10 software. This study finds multiple factors contributing to the growth and development of restorative justice in Saskatchewan. Dissatisfaction with the current criminal justice system, increased awareness of restorative justice, and faith-based organizations such as the Mennonite Central Committee (MCC), Indigenous-led justice organizations and funding support from both provincial and federal governments facilitated the growth of RJ in SK. This study captures a major discussion of government in restorative justice. This study ends with sharing some limitations and areas for future research.

The impact of hygienic living conditions on the differentiation of male body height at the beginning of the twentieth century in the USSR

BackgroundThe positive changes in hygienic living conditions are commonly believed to explain secular changes in body height and the age of maturity. However, it is difficult to estimate the separate impacts of these factors due to the lack of social and economic data and variations in the sources of information.We hypothesized that final male body height could be associated with various socioeconomic indicators, such as the development of the medical care system, the quality of nutrition, and the level of sanitary and hygienic conditions. Moreover, we hypothesized that male body height could be associated with the level of morbidity in the region during the time of conscript childhood (from 1 to 7 years old).Materials and methodsWe used two main sources of information in the analyses. The first is the data from the Statistical Reference Book published by the Central Statistical Committee in 1929. The second is the annual data from the Statistical Reference Book published in the Russian Empire. Since the conscripts were born between 1906 and 1909, we used datasets from 1910 to 1913. To analyze the data, we used a method of analyzing interacting variables called St. Nicolas House Analysis (SNHA).ResultsOur analyses revealed direct associations between the morbidity of some diseases and male body height and other anthropometric parameters.ConclusionsThere are associations between conscript final body height and the morbidity of influenza, dysentery and some venereal diseases, such as chancroid and syphilis. There were no associations between conscript final body height and the level of morbidity during childhood. However, other final parameters, such as BMI, weight, and chest circumference, could be associated with the morbidity of malaria, scabies, scurvy, and scarlet fever during childhood. The prevalence of these diseases could be strongly connected with unfavorable living conditions. The results are similar for both urban and rural areas.

A phase 2 study of mobocertinib as first-line treatment in Japanese patients with non-small cell lung cancer harboring EGFR exon 20 insertion mutations.

Mobocertinib is a novel, synthetic, orally administered tyrosine kinase inhibitor that inhibits many activated forms of epidermal growth factor receptor (EGFR), including those containing exon 20 insertion (ex20ins) mutations. This study aimed to assess the efficacy of mobocertinib in Japanese patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR ex20ins mutations. This was a phase 2, open-label study. Patients with NSCLC harboring EGFR ex20ins mutations who had not had previous systemic treatment received mobocertinib 160 mg once daily. The primary endpoint was the confirmed objective response rate. A planned interim analysis was completed for the first 14 patients with a centrally confirmed EGFR ex20ins mutation, with enrollment stopped if the number of patients with an objective response was five or fewer. In total, 33 patients were enrolled into the study (63.6% women; median age: 66 years). At the interim analysis, the objective response rate evaluated by a central independent review committee was 28.6% (4/14, 90% confidence interval: 10.4-54.0); therefore, enrollment was stopped for futility. In the full analysis set, the objective response rate was 18.2% (6/33, 95% confidence interval: 7.0-35.5); of the six responders, one patient (3.0%) had a complete response and five patients (15.2%) had partial responses. The most common treatment-related adverse events were diarrhea, paronychia, stomatitis, and nausea. Although study enrollment was terminated early owing to futility, our results showed modest activity of mobocertinib in Japanese patients with NSCLC with EGFR ex20ins mutations with no additional safety concerns.

Unwilling allies: the USSR, the Communist Party of Argentina, and the military dictatorship in Argentina, 1976–1983

The author of this article aims to explore the complex and contradictory relationship between the Communist Party of Argentina, the Soviet Union, and the military regime in Argentina between 1976 and 1983. It was a period of right-wing military dictatorship domination in the region, characterised by outright terrorist policies against left-wing forces, mass violations of human rights, which put the International Communist Movement in an ambiguous position due to the USSR’s close cooperation with the Argentine military junta. A unique situation of mutual interest between Soviet foreign policy and the military dictatorship developed in the USSR’s relations with the military regime in Argentina. The most important factor in this contradictory situation was the position of the Communist Party of Argentina, supported by the CPSU, on co-operation with a regime that other communist parties and leftist forces qualified as fascist, ultra-reactionary, and anti-communist. The USSR found moral and political justification for its cooperation with the Argentine regime in the policies of local communists who supported the regime, justifying its repression of leftist radical movements, especially the Montoneros. The Argentine Communist Party justified its policy by referring to the junta’s growing cooperation with the USSR. The article explores the reasons for this policy of the Communist Party, which caused tension in the international communist movement and the subsequent isolation of the Argentinian Communist Party. The specific political interests of the USSR were supported by the Argentine communists, who, in turn, saw in them a guarantee of their interests in the conditions of the harsh right-wing military regime in the country. For the first time in historiography, this paper, drawing on records from the archive of the CPSU Central Committee, documents the complex process of reconciling the USSR’s economic and political interests in Argentina during this difficult period of the Cold War.

CCUS source-sink matching model based on sink well placement optimization

Realizing the dual-carbon target is a major strategic plan made by the Party Central Committee and a solemn commitment to address climate change of global significance. Source-sink matching technology in carbon capture, utilization, and storage (CCUS) technology is crucial to achieving the dual-carbon target. However, most previous studies constructed source-sink matching models based on sink-fixed sequestration potential, making it difficult to accurately assess the potential of sequestration sites and thus affect the source-sink matching scheme. Therefore, a dynamic storage potential assessment model has been established which can quickly assess the injection capacity of sinks under different well deployment schemes and then a source-sink matching model based on the overall optimization of sink deployment schemes has been constructed by combining the dynamic storage potential assessment model. The model considers the source matching problem as a mixed-integer linear programming (MILP) problem and obtains the computational results of the dynamic storage potential assessment model to realize the correct matching and simultaneous optimization of the source-sink pipeline network layout and the sink-well deployment scheme. With the proposed model, source-sink matching cases for national-level and project-level have been analyzed. It has been shown that the dynamic storage potential assessment model and the combined method improve the accuracy of the source-sink matching model in the form of MILP while minimizing the total cost and additional computations.

The Third Plenum of the CCP Central Committee: Factors of Instability and Development Prospects

The Third Plenary Session of the 20th CPC Central Committee (June 15–18) was one of the central events in China's political life in 2024. The delay for more than six months in holding the plenum increased the sense of growing instability in China's development, caused by the slow economic recovery after the pandemic, as well as the high-profile resignations of Foreign Minister Qin Gang and Defense Minister Liu Shangfu. The technical postponement of the plenum disrupted the procedure for making the most important state decisions typical for the Soviet-type republics. The timing and agenda of the plenum reaffirmed the seriousness of the challenges faced by the Communist Party leadership in the economy and on the international arena. The Communist Party's search for a new model and a new theoretical concept of development is complicated by the need to take into account not only the constantly worsening international situation, the economic difficulties and socio-economic problems, but also the emergence of new productive forces and changes in the mode of production caused by the use of artificial intelligence, digital technologies, etc. The process of searching for new theoretical foundations continued at the plenum, the Decision of which formulated the main provisions for the development of China until 2029. Special attention was paid to the development of innovations, fundamental research, and the development of international cooperation in science and education in order to maintain high economic growth rates. Noticeably less attention was paid to solving social problems and social justice. An important direction of intra-party life was the continuing weakening of the role of the military in the leadership of the party and the political system of the PRC.

The Second Session of the 14th National People's Congress: Outcomes of China's Legislative Development in 2023

The regular (second) session of the 14th National People's Congress (NPC), held in March 2024, summarized the key outcomes of China's socio-economic and legislative development in the second year following the 20th CPC National Congress (October 2022). According to established tradition, the third plenum of the 20th Central Committee of the CPC should have been held on the eve of the parliamentary session, with its decisions typically focusing on the country's economic development. In turn, the decisions of the NPC are based on the work of the plenum, often taking the form of laws. However, in 2024, although the plenum did not take place, the NPC session proceeded as scheduled, with no changes to its working agenda. In the report of the State Council’s Premier, it was noted that China's GDP growth reached 5.2 %, one of the highest figures among both developing and developed countries. In the legislative sphere, in 2023, the Chinese parliament, represented by the Standing Committee of the NPC, passed a number of important laws for the country's legal system, and several existing laws were amended. Of particular note are the Law on Foreign Relations, which outlines the key principles of China's foreign policy, and the Law on the Immunity of Foreign States, which replaced the previously existing principle of "absolute immunity" with "limited immunity." In the fight against corruption, significant changes were made through the 12th amendments to the Criminal Law of the PRC. Additionally, legislative decisions focused on developing a mechanism to counter growing challenges and threats to Chinese statehood, finding adequate responses to sanction policies, implementing measures to create a stable financial and banking system, and strengthening the military amid rising tensions in the Taiwan Strait and the South China Sea.

Formation of the Youth Union (Komsomol) in Kyrgyzstan in the 10-20s of the XX Century

On the initiative of the Central Committee of the RCP (b), in July 1918, the Organizing Bureau was created to convene a youth congress. On October 29, 1918, the First Congress of the All-Russian Congress of Workers’ Peasant Youth Unions opened in Moscow. He discussed reports from the field, approved the Charter and the main theses of the Komsomol Program. In the theses, emphasizing the solidarity of the Russian Communist Youth Union (RCYU) and the RCP(b), the congress formulated the goals of the Komsomol: active participation in the propaganda of the idea of ​​communism, the involvement of worker and peasant youth in active Soviet construction; determined the forms and methods of cultural and educational work among young people, etc.

China's Policy in the Field of Artificial Intelligence

Today, China has achieved tremendous success in the field of information technology and is actively promoting the modernization of the country and increasing its competitiveness in the world through progressive digitalization and informatization of all sectors of life and production. With more than a billion registered users of the global information network, actively using the scientific and educational potential of the country, China keeps information policy in the zone of close attention, as evidenced, in particular, by the fact that it was created in 2014. Since its creation, the Central Commission of the CPC Central Committee on Internet Security and Informatization has been personally headed by Xi Jinping. China is aware of the serious risks associated with the development of AI, but also understands the importance of this area for further development and improving the country's competitiveness. In this regard, the political leadership is taking systematic steps and measures for the healthy and safe development of this area in the country and in the world. The information sphere is no less important for Russia, especially in the context of attempts to isolate it and displace it to the global periphery, therefore, in the current conditions, the topic of cooperation with China in the field of information technology is of particular priority for Russia. This is evidenced by its inclusion in the final joint Russian-Chinese statement of May 16, 2024 following the meeting of the heads of state in Beijing. The article examines the general situation of the formation of AI regulatory tools in the world and, above all, in the PRC. A number of documents adopted by the country's top political leadership, as well as expert assessments and opinions, were reviewed.

Changes in the Inter-Korean Policy of the DPRK and the ROK and Prospects for the Development of the Situation on the Peninsula

At the December plenum of the Central Committee of the WPC in 2023 and the January session of the National Assembly of the DPRK in 2024. North Korea has radically changed inter-Korean policy, abandoning the course of "unification of the country." The authorities have disbanded relevant structures and intend to "completely remove from the national history of our Republic the very concept of "unification", "reconciliation" and "compatriots". According to Kim Jong-un, the DPRK and the Republic of Korea have finally become "hostile states" for each other, their relations are no longer determined by belonging to the same people, so the peaceful unification of the Korean peninsula is no longer considered possible. This course testifies to the recognition by the country's leadership of objective reality and does not lead to an increase in the probability of an inter-Korean conflict initiated by Pyongyang. This change of course was largely the result of the processes in the south of the peninsula, where the government of Yoon Seok-Yeol, on the contrary, strengthens the rhetoric of "achieving peace through force". The author considers President Yoon's speech on March 1, 2024, formally dedicated to the 105th anniversary of the March 1, 1919 movement to be a sign of the new course. This speech can be considered as a program of a new inter-Korean policy aimed at eliminating the DPRK by the international community. The changed relations between Seoul and Pyongyang should be perceived as a consequence of changes in the world order and the global security architecture, as the concepts that do not meet the new reality are revised or canceled. At the same time, Russia may be satisfied with the presence of a cold war on the peninsula, if it does not turn into a hot one, as well as with the further rapprochement between Moscow and Pyongyang, united by a common threat.

Examining representation of women in leadership of professional medical associations in India.

Women constitute 70% of the global health workforce but are significantly underrepresented in leadership positions. In India, professional medical associations (PMAs) play a crucial role in shaping policy agenda in the health sector, but very little is known about gender diversity in their leadership. Therefore, we analysed the gender representation of current and past leaderships of Indian PMAs. Data of the current and past national leadership and leadership committees of 46 leading PMAs representing general, specialities, and super-specialities were extracted from their official websites. Gender composition of leadership was analysed using a sequential approach. For Indian Medical Association (IMA), the largest Indian PMA, an analysis of its 32 sub-chapters was also undertaken. The findings revealed that only 9 (19.5%) out of 46 associations are currently led by a woman. Leadership committees of half the associations have less than 20% women, while there were no women in the central committee of nine PMAs. Among past presidents, information was publicly available for 31 associations and all of them have had less than 20% of women presidents till date. Among the 64 individuals currently serving as presidents and secretaries of 32 sub-chapters of IMA, only three (4.6%) are women. Even in associations closely related to women's health, such as obstetrics and gynecology, pediatrics, and neonatology, unequal representation persists, highlighting male dominance. These results demonstrate significant gender disparities in PMA leadership in India, necessitating urgent efforts to promote gender equality. Gender-transformative leadership is crucial to develop gender-sensitive health care policies and practices which can serve as a catalyst for broader societal change.

Predicting radiotherapy response, Toxicities and quality-of-life related functional outcomes in soft tissue sarcoma of the extremities (PredicT) using dose–volume constraints development: a study protocol

IntroductionRadiotherapy improves local tumour control in patients with soft tissue sarcoma of the extremities (STSE) but it also increases the probability of long-term toxicities such as tissue fibrosis, joint stiffness...

Execution of decisions of the Constitutional Court of Ukraine: separate doctrinal approaches

It is indicated that the key problem in the activity of the Constitutional Court of Ukraine is ensuring the implementation of its decisions. Without solving this issue, it is impossible to guarantee the supremacy of the Constitution, the principle of separation of powers and the existence of an independent judicial branch of government as a separate institution. Ignoring the decisions of the constitutional control body undermines the very system of checks and balances, the authority of the Basic Law and the constitutional order in the country in general. These principles underlie the implementation of decisions of constitutional courts, the purpose of which is to ensure constitutional legality. In Ukraine, the mechanism for the implementation of the decisions of the Central Committee of Ukraine has already been developed in general, but there are problems related to the non-implementation of some of its decisions for a long time. Therefore, the task of further improvement of this mechanism and its proper legislative regulation remains relevant. The authors claim that Ukraine has already developed a mechanism for implementing decisions of the Constitutional Court. However, this system is not perfect, which is evidenced by the fact of non-execution of individual court decisions. Therefore, the issue of continuing the work on improving the existing mechanism for implementing decisions of the body of constitutional jurisdiction, securing it properly at the legislative level, remains urgent. At the same time, the problem of the quality of such execution comes to the fore, for the solution of which it is necessary to develop criteria for the effectiveness of the execution of court decisions, which will allow to assess the quality of the legal acts that are introduced and the work of the responsible entities. Both outlined problems definitely need further thorough scientific research. In addition, according to the authors, it should be noted that the issues of the legal nature of the legal positions of the Constitutional Court of Ukraine and the criteria for the effective implementation of its decisions remain interacting categories and, therefore, require thorough scientific study. At the same time, clarifying the legal force of the Court’s legal positions is complicated by the lack of their legislative definition, by a certain difficulty in understanding the role and place of the body of constitutional jurisdiction in the system of state power. At the same time, the legal positions have a normative and mandatory character, reflected in the acts of the KSU. The need to ensure their immutability follows from the principles of legal certainty and stability of the Constitution. However, the possibility of revising some legal positions in connection with the change in the socio-political structure of the state is gaining relevance.

The Present Situation Analysis and Optimization Measures of Kindergarten Labor Education from the Perspective of Returning to Life

This study is guided by the Opinions of the Central Committee of the Communist Party of China and the State Council on Comprehensively Strengthening Labor Education in Primary and Secondary Schools in the New Era, combined with the relevant requirements of the Guidelines for Kindergarten Education (Trial), from the perspective of returning to life. The status quo of kindergarten labor education was analyzed in depth. Through systematic review and practical observation, it is found that there are some problems in the implementation of kindergarten labor education, which are mainly manifested in the lack of policy basis, the lack of professional teachers, the imperfect curriculum system, and the low support of parents. This study believes that labor is an integral part of life. Labor education should return to life, guide children to understand the world with its practicality, foundation, and comprehensiveness, form a positive labor quality, improve aesthetic ability, and lay a good foundation for the connection between preschool children. Based on this, this paper puts forward the strategy of optimizing kindergarten labor education, including integrating kindergarten labor education into life to cultivate childrens labor habits, combining family life to expand childrens labor experience, and connecting community life to enhance labor cognition, so as to provide operable ideas and suggestions for the development of kindergarten labor education.

Costs of non-multidrug-resistant pulmonary tuberculosis and of preventive treatment in Germany – An update

BackgroundOnly 4076 new cases of tuberculosis (TB) were reported in Germany in 2022; of those 184 were multidrug-resistant TB (MDR-/RR-TB). MethodsBased on the current therapy guidelines of the German Central Committee against Tuberculosis and most recent renumeration data of the Statutory Health Insurances (SHI), this study estimates the mean in- and outpatient costs per adult infectious pulmonary non-MDR-TB patient, together with costs arising from Rifampicin (RIF)-based short-course options of tuberculosis preventive treatment (TPT) of their close contacts. ResultsFrom the insurance perspective, the mean inpatient cost (rounded) per adult case was 6138 EUR (SD±2810 EUR) for standard therapy; the cost of primary outpatient treatment only amounted to 1930 EUR and the cost of outpatient treatment post-hospital to 1093 EUR. The mean weighted cost was 6377 EUR (SD±2357 EUR), a drop of 27 % vs. 2019. This is mainly due to a decrease in hospitalizations of 5.6 %, and, given hospital treatment, by a 95 EUR decrease in the per-day reimbursement rate for TB patients who are hospitalized for at least 14 days. In contrast, the mean costs of TPT per person were 466 EUR (RIF solely over 4 months) and 423 EUR (RIF combined with Isoniazid over 3 months). ConclusionWhile costs for active non-MDR-TB treatment in Germany have clearly decreased thanks to increased engagement on the part of the private practice sector and lower reimbursement rates in hospital, the comparatively high costs of short-course TPT have surprisingly significant economic impact. This negative development can be countered through diligent selection of close contacts persons of infectious TB cases before using IGRA testing to detect latent TB, to minimize the number of those persons who are tested falsely determined to be at risk and needlessly undergo TPT.

Ideology and the Constitution: Freedom of National Development of Peoples

The paper examines the provisions of the first Constitution of the USSR, approved in its final version on January 31, 1924, from the point of view of Marxist‑Leninist ideology. The author concludes that the basic law found the necessary balance between centralization, republican autonomy, and the principles of socialist federalism. Many provisions of the document can be called ideological. On the one hand, the law‑maker of the first Soviet years blames the camp of capitalist countries for national hostility or colonial slavery, chauvinism or imperialist atrocities. On the other hand, the Soviet government, which was international in its class nature, was supposed to be entrusted with the high mission of uniting fraternal peoples and restoring the national economy by the forces of a single socialist family under the banner of the proletarian dictatorship. The state aimed to unite the workers of various political and economic systems around the globe under the auspices of the world socialist Soviets. Numerous research publications of prominent Bolsheviks on the problems of the national question, based on the fundamental works by K. Marx, F. Engels, K. Kautsky, acted as the theoretical basis for the declarative provisions of the first Constitution of the USSR. Based on the protocol documents of the Central Committee of the Russian Communist Party (b), the author notes the significant role of Stalin’s personal administrative hobby in the development of historical and legal events. Nevertheless, the General Secretary of the party did not dare to go against the principles of democratic centralism or the International supported by Vladimir Lenin. The development of the terminology of the nation and the advantages of various ways of voluntary unification of peoples, the comparison of models of cultural‑national or regional autonomizations in the works of the Bolsheviks play a great role.

Role of central endpoint adjudication and challenges in trials on neonatal sepsis—a case of ProSPoNS trial

Despite progress in reducing the infant mortality in India, the neonatal mortality decline has been slower, necessitating concerted efforts to achieve Sustainable Development Goal-3. A promising strategy aiming to prevent neonatal sepsis in high-risk, vulnerable, low birth weight neonates through an innovative intervention includes probiotic supplementation. This article communicates the decision by the ProSPoNS trial investigators to establish a Central Endpoint Adjudication Committee (CEAC) as an addendum to the protocol published in Trials in 2021 for the purpose of clarifying the primary outcome. In the published protocol, the study hypothesis and primary objective are based on “sepsis,” the primary outcome has been specified as sepsis/PSBI, whereas the sample size estimation was performed based on the “physician diagnosed sepsis.” To align all the three above, the investigators meeting, held on 17th–18th August 2023, at MGIMS Sevagram, Wardha, deliberated and unanimously agreed that “physician diagnosed sepsis” is the primary study outcome which includes sepsis/PSBI. The CEAC, chaired by an external subject expert and members including trial statistician, a microbiologist, and all site principal investigators will employ four criteria to determine “physician diagnosed sepsis”: (1) blood culture status, (2) sepsis screen status, (3) PSBI/non-PSBI signs and symptoms, and (4) the clinical course for each sickness event. Importantly, this clarification maintains consistency with the approved study protocol (Protocol No. 5/7/915/2012 version 3.1 dated 14 Feb 2020), emphasizing the commitment to methodological transparency and adherence to predefined standards. The decision to utilize the guidance of a CEAC is recommended as the gold standard in multicentric complex clinical trials to achieve consistency and accuracy in assessment of outcomes.Trial registrationClinical Trial Registry of India (CTRI) CTRI/2019/05/019197. Registered on 16 May 2019.