bluuebunny/crossref_metadata_2025_split huggingface dataset:
Pitfall in the Design and Analysis of Comparative Oncology Trials With a Time-to-Event Endpoint and Recommendations
Authors: McCaw Zachary R , Kim Dae Hyun , Wei Lee-Jen 
Published: January 2022

Abstract
When designing a comparative oncology trial for an overall or progression-free survival endpoint, investigators often quantify the treatment effect using a difference in median survival times. However, rather than directly designing the study to estimate this difference, it is almost always converted to a hazard ratio (HR) to determine the study size. At the analysis stage, the hazard ratio is utilized for formal analysis, yet because it may be difficult to interpret clinically, especially when the proportional hazards assumption is not met, the observed medians are also reported descriptively. The hazard ratio and median difference contrast different aspects of the survival curves. Whereas the hazard ratio places greater emphasis on late-occurring separation, the median difference focuses locally on the centers of the distributions and cannot capture either short- or long-term differences. Having 2 sets of summaries (a hazard ratio and the medians) may lead to incoherent conclusions regarding the treatment effect. For instance, the hazard ratio may suggest a treatment difference whereas the medians do not, or vice versa. In this commentary, we illustrate these commonly encountered issues using examples from recent oncology trials. We present a coherent alternative strategy that, unlike relying on the hazard ratio, does not require modeling assumptions and always results in clinically interpretable summaries of the treatment effect.
Cancer Health Economics Research: The Future Is Now
Authors: Halpern Michael T , Lipscomb Joseph , Yabroff K Robin 
Published: January 2022

Abstract
The goals of the “Future of Cancer Health Economics Research” virtual conference were to identify challenges, gaps, and unmet needs for conducting cancer health economics research; and develop suggestions and ideas to address these challenges and to support the development of this field. The conference involved multiple presentations and panels featuring several key themes, including data limitations and fragmentation; improving research methods; role and impacts of structural and policy factors; and the transdisciplinary nature of this field. The conference also highlighted emerging areas such as communicating results with nonresearchers; balancing data accessibility and data security; emphasizing the needs of trainees; and including health equity as a focus in cancer health economics research. From this conference, it is clear that cancer health economics research can have substantial impacts on how cancer care is delivered and how related health-care policies are developed and implemented. To support further growth and development, this field should continue to welcome individuals from multiple disciplines and enhance opportunities for training in economics and in analytic methods and perspectives from across the social and clinical sciences. Researchers should continue to engage with diverse stakeholders throughout the cancer community, building collaborations and focusing on the goal of improving health and well-being.
Jejunal intussusception due to an atypical lipomatous tumor: a rare case report
Authors: Karampa Anastasia , Stefanou Christos K , Stefanou Stefanos K , Tepelenis Kostas , Tsoumanis Periklis , Ntalapa Konstantina M , Giannouli Paraskeui , Pappas-Gogos George , Vlachos Konstantinos 
Published: January 2022

Abstract
Intussusception in adults is rare, and the clinical symptoms of intussusception are subtle, making the diagnosis quite challenging. Gastrointestinal lipomas are rare benign tumors and are essentially adipose growths, most frequently found within the small intestine wall or mesentery. Limited up-to-date evidence exists regarding such lipomas. Intussusception due to a gastrointestinal lipoma constitutes an infrequent clinical entity, and the diagnosis of duodenal lipoma mainly depends on endoscopy examination, supplemented by computed tomography and magnetic resonance imaging. The present report describes a case of jejunal intussusception in an adult with a history of intermittent colicky abdominal pain located in the left upper quadrant over the last month. Contrast-enhanced computed tomography of the abdomen showed the typical target sign of a small intestinal intussusception along the left upper quadrant and a well-defined, low-density tumor in the intussusception. Exploratory laparotomy revealed jejuno-jejunal intussusception secondary to a lipoma, which was successfully treated with segmental intestinal resection.
Increasing Participation in a Mobile App Study: The Effects of a Sequential Mixed-Mode Design and In-Interview Invitation
Authors: Jäckle Annette , Wenz Alexander , Burton Jonathan , Couper Mick P 
Published: January 2022

Abstract
Mobile apps are an attractive and versatile method of collecting data in the social and behavioral sciences. In samples of the general population, however, participation in app-based data collection is still rather low. In this article, we examine two potential ways of increasing participation and potentially reducing participation bias in app-based data collection: (1) inviting sample members to a mobile app study within an interview rather than by post and (2) offering a browser-based follow-up to the mobile app. We use experimental data from Spending Study 2, collected on the Understanding Society Innovation Panel and on the Lightspeed UK online access panel. Sample members were invited to download a spending diary app on their smartphone or use a browser-based online diary to report all their purchases for one month. The results suggest that inviting sample members to an app study within a face-to-face interview increases participation rates but does not bring in different types of participants. In contrast, the browser-based alternative can both increase participation rates and reduce biases in who participates if offered immediately once the app had been declined. We find that the success of using mobile apps for data collection hinges on the protocols used to implement the app.
The Role of National Competition Authorities
Authors: Pablo Alfonso Lamadrid de , Sinclair Ailsa 
Published: January 2022

Abstract
This chapter examines the role of national competition authorities (NCAs). Under Regulation 1/2003, it is not only the European Commission but also the NCAs that are responsible for enforcing the EU competition rules. Regulation 1/2003 created a system of parallel competences in which the competition rules are enforced by a network of competition authorities as well as by the national courts. Provided trade between Member States is affected, Regulation 1/2003 allows NCAs to apply Articles 101 and 102 TFEU but leaves the Member State free to determine which body will enforce the rules and which mechanism for investigating infringements and enforcing decisions will apply. Article 11(6) of Regulation 1/2003 provides that if the Commission initiates proceedings for the adoption of a decision, the NCAs no longer have jurisdiction to apply Articles 101 and 102 TFEU. Yet a central feature of Regulation 1/2003 is that NCAs may apply Articles 101 and 102 TFEU in individual cases. The chapter then considers the cooperation between the Commission and the NCAs, as well as the principles and procedures for cooperation with third countries. It also studies the ECN+ Directive, which empowers the competition authorities of the Member States to be more effective enforcers.
Opening of the File
Authors: Jörgens Konstantin , Blanco Luis Ortiz 
Published: January 2022

Abstract
This chapter looks at the opening of the file and of proceedings concerning infringements. Instead of spending its time processing notifications of largely benign agreements, the objective of Regulation 1/2003 was to enable the Commission to use its limited resources to crack down on serious infringements, such as cartels. The widening of the Commission's investigatory powers was precisely aimed at enhancing methods of discovering cartel activity at all levels of enforcement. However, in so doing, it is dependent on receiving information from third parties, either informally or through formal complaints. In essence, cartels and other anticompetitive practices can come to light either directly, through whistle-blowers and complaints by third parties, or indirectly, through other regulatory activities, such as sector inquiries or merger investigations. The Commission strongly encourages citizens and undertakings to inform public enforcers about suspected infringements of the competition rules as complainants. Proceedings conducted by the Commission in competition matters may be commenced by the Commission on its own initiative or in response to a complaint. Throughout the procedure, the Commission has indicated that, on its own initiative or upon request, it endeavours to give parties subject to the proceedings ample opportunity for open and frank discussions, taking into account the stage of the investigation, and to make their points of view known.
Investigation of Cases (I)
Authors: Hödlmayr Corneliu , Blanco Luis Ortiz 
Published: January 2022

Abstract
This chapter assesses the leniency policy. Since the 1990s, competition authorities around the world encourage companies to report their own antitrust violations in exchange for ‘amnesty’ or ‘leniency’ from fines. Simply put, leniency programmes offer companies incentives to ‘blow the whistle’ on cartels, making cartel participation riskier and creating a ‘race to confess’ in order to obtain full immunity. Such a policy is based on the recognition that while cartels rank among the most serious violations of competition rules, the collection of evidence to prosecute them is increasingly difficult. In 1996, the European Commission adopted the Notice on the non-imposition or reduction of fines in cartel cases (the 1996 Notice). Under the 1996 Notice, the first company to provide ‘decisive evidence’ of a cartel could gain between a 75 per cent reduction to full immunity from fines. The 1996 Notice was replaced in February 2002 by the ‘2002 Notice’ that changed the earlier system and was largely modelled on the US ‘amnesty’ programme. In December 2006, the leniency regime was again updated by the ‘2006 Notice’. Finally, in March 2019, the Commission launched e-Leniency, a new online IT tool designed to facilitate the filing of statements and submissions by undertakings in the context of leniency applications.
Procedures to Establish the Existence of an Infringement
Authors: Kellerbauer Manuel , Centella Marisa Tierno , Lamadrid Alfonso 
Published: January 2022

Abstract
This chapter studies the procedures to establish the existence of an infringement. The administrative procedure under Regulation 1/2003, which takes place before the European Commission, is divided into two distinct and successive stages, namely a preliminary investigation stage and an inter partes stage. The preliminary investigation stage covers the period up until the notification of the statement of objections. It is intended to enable the Commission, with the help of the powers of investigation provided for in Regulation 1/2003, to gather all the relevant information tending to prove or disprove the existence of an infringement of the competition rules and to adopt an initial position on the course of the procedure and how it is to proceed. By contrast, the inter partes stage, which covers the period from the notification of the statement of objections to the adoption of the final decision, must enable the Commission to reach a final decision on the potential infringement concerned. The inter partes stage involves frequent contacts with the companies subject to investigation and this is also with a view to ensuring that they have ample opportunity to comment on all elements of fact and of law which the Commission may take into account when adopting the final decision.
General Questions on Procedure
Authors: Keppenne Jean Paul , Caviedes Carlos Urraca 
Published: January 2022

Abstract
This chapter discusses the procedure for the control of State aid. Article 108 of the Treaty on the Functioning of the European Union (TFEU) provides for a special control system to check on the compatibility of aid. This comes largely under the control of the European Commission, which not only decides beforehand on the compatibility of new aid, but also permanently reviews existing aid schemes. As part of this latter role, the Commission, in cooperation with Member States, decides whether or not the smooth running of the internal market calls for these schemes to be altered or abolished. If so, the Commission has to follow the procedure laid down in paragraphs 1 and 2 of Article 108 TFEU when ordering the Member State(s) concerned to alter or abolish their schemes, with future effect. As regards new aid, the Commission is empowered to rule directly on its compatibility. To enable the Commission to carry out this task, Member States are bound to notify it of their aid plans before putting them into effect. Aid declared to be incompatible with the internal market by the Commission cannot be granted; if it has already been paid unlawfully, the Commission will ask the Member State in question to recover it from the undertaking that has benefited from it. National courts, moreover, have the power to enforce the obligation to notify new aid.
Control of Existing Aid Schemes
Authors: Keppenne Jean Paul , Caviedes Carlos Urraca 
Published: January 2022

Abstract
This chapter looks at existing aid schemes. The category of existing aid takes in the whole set of aid that can be or has been granted by Member States. The notion of existing aid aims to ensure legal certainty for Member States and recipient undertakings by guaranteeing the legality of the aid concerned. Existing aid can therefore continue to be paid as long as the European Commission has not found it to be incompatible with the internal market. The existing aid schemes in the various Member States are permanently reviewed by the Commission under Article 108(1) of the Treaty on the Functioning of the European Union (TFEU). It can propose or demand that these schemes be altered or abolished when it considers that their compatibility with the internal market is not clear. The chapter then details the procedural arrangements for the permanent review system exercised by the Commission in cooperation with Member States.
The Scope of the Crowdfunding Regulation and the Impact of Brexit
Authors: Ivanova Petja 
Published: January 2022

Abstract
This chapter clarifies the scope of application of the Crowdfunding Regulation. It also discusses the impact of Brexit on the application of the crowdfunding legal framework and the further development of the crowdfunding market. According to Article 1(1), the uniform requirements of the Crowdfunding Regulation apply to crowdfunding service providers (CSPs), including their organisation, authorization, and supervision and the operation of crowdfunding platforms, and to the provision of crowdfunding services and transparency and marketing communications. Yet, the provisions of the Crowdfunding Regulation either remain inapplicable to particular forms of crowdfunding, or result in an interdependence with other existing EU instruments. Despite the obstacles still existing and within the limits of the Crowdfunding Regulation, cross-border operations of CSPs throughout the Union are significantly facilitated.
Principles of International Investment Law
Authors: Kriebaum Ursula , Schreuer Christoph , Dolzer Rudolf 
Published: January 2022

Abstract
This book outlines the principles behind the international law of foreign investment, focussing on the law governed by bilateral and multilateral investment treaties. The book traces the purpose, context, and evolution of the clauses and provisions characteristic of contemporary investment treaties, and analyses the case law, interpreting the issues raised by standard clauses. Particular consideration is given to broad treaty rules whose understanding in practice has mainly been shaped by their interpretation and application by international tribunals. In addition, the book describes the dispute settlement mechanisms for enforcing investment law, outlining the operation of Investor v State arbitration. This third edition has been fully updated to reflect the evolution of treaty practice, jurisprudence, and doctrinal opinion, covering new treaties such as the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP), United States–Mexico–Canada Agreement (USMCA), and the Comprehensive Economic and Trade Agreement (CETA). Each chapter is introduced by a bibliography of recent publications. Combining a systematic analytical study of the texts and principles underlying investment law with a jurisprudential analysis of the case law arising in international tribunals, the book offers an ideal introduction to the principles of international investment law and arbitration, for students and practitioners alike.
Investment Contracts
Authors: Dolzer Rudolf 
Published: January 2022

Abstract
This chapter focuses on investment contracts. Since large-scale investments involve interests of the investor as well as public interests of the host State, general legislation of the host country may not sufficiently address the nature of the project and the kind of interests concerned. The legal setting of an investment may need to be adjusted to its specifics and complexities by way of an investment contract. The investment contract will reflect the bargaining power of both sides under the circumstances of the individual project. Depending upon the bargaining power and the negotiating skill of the parties, a number of possible choices have emerged for the law applicable to the contract and the agreement on dispute resolution. These range from a choice of the law of the host State to an exclusive choice of international law. The matter will also be determined by the position of international law in the domestic order of the host State. The chapter then looks at stabilization and renegotiation clauses and considers the relationship of investment contracts with investment treaties.
Admission and Establishment
Authors: Dolzer Rudolf 
Published: January 2022

Abstract
This chapter assesses the admission and establishment of foreign investors. Admission concerns the right of entry of the investment in principle, whereas establishment pertains to the conditions under which the investor is allowed to carry out its business during the period of the investment. From the perspective of general international law, States are in no way compelled to admit foreign investments. The economic dimension of territorial sovereignty leaves it to each government to decide whether to close the national economy to foreign investors or to open it up, fully or with respect to certain sectors. This includes the right to determine the modalities for the admission and establishment of foreign investors. Views differ on whether it is useful to conclude treaties providing for guarantees towards liberalization or whether the flexibility inherent in domestic legislation subject to continuous review provides more benefits for the host State's national economy. The policy decision of the host State whether to grant a right of admission is fundamental for all parties to investment treaties. The chapter also looks at the provisions on investment promotion and performance requirements.
Expropriation
Authors: Dolzer Rudolf 
Published: January 2022

Abstract
This chapter addresses the rules of international law governing the expropriation of alien property. Consistent with the notion of territorial sovereignty, the classical rules of international law have accepted the host State’s right to expropriate alien property. Customary international law placed certain limitations on the host State’s right to take alien property, but even modern investment treaties respect the right to expropriate in principle. Treaty law typically addresses only the conditions and consequences of an expropriation, leaving the right to expropriate as such unaffected. The legality of an expropriation depends on whether these conditions have been met. Practice shows that claims for expropriations relate to a variety of assets, tangible and intangible, and even to arbitral awards. Among intangible assets, the expropriation of contract rights has played an important role in practice. The chapter then looks at how indirect expropriations have gained in importance. An indirect expropriation leaves the title untouched but deprives the investor of the possibility to utilize the investment in a meaningful way. A typical feature of an indirect expropriation is that the State will deny the existence of an expropriation and will not contemplate the payment of compensation.
Standards of Protection
Authors: Dolzer Rudolf 
Published: January 2022

Abstract
This chapter describes the standards of protection under international investment law. Most bilateral investment treaties (BITs) and other investment treaties provide for fair and equitable treatment (FET) of foreign investments. Thus, this concept is the most frequently invoked standard in investment disputes. It is also the standard with the highest practical relevance: a major part of successful claims pursued in international arbitration are based on a violation of the FET standard. The chapter then considers the notion of full protection and security (FPS); arbitrary or discriminatory measures; clauses on national treatment; most-favoured-nation (MFN) clauses; and ‘umbrella clauses’. It also looks at the explicit obligation to provide effective means to assert claims and enforce rights, and the conditions for the transfer of funds by investors into the host State and out of the host State.
Emergency Situations and Armed Conflicts
Authors: Dolzer Rudolf 
Published: January 2022

Abstract
This chapter explores the legal rules applicable to extraordinary events and periods of economic and social disorder. The relevant international rules are contained in customary international law codified by the International Law Commission (ILC). Situations beyond the host State’s control are addressed in the ILC's Articles on Responsibility of States for Internationally Wrongful Acts (ARSIWA) under the headings ‘force majeure’ (Article 23), ‘distress’ (Article 24), and ‘necessity’ (Article 25). In addition, treaties for the protection of foreign investments contain relevant provisions. The Vienna Convention on the Law of Treaties (VCLT) offers the doctrines of supervening impossibility of performance (Article 61) and of fundamental change of circumstances (Article 62) to deal with extraordinary developments such as emergencies and armed conflict. To the extent that the ILC Draft Articles represent the law governing the effects of armed conflict on treaties, they tend to support the principle of the continued applicability of investment treaties.