Search Results (366)

The designs of clinical trials of drugs for rare diseases are challenged by health technology assessment organisations and payers. Phase II pivotal studies, single-arm or open-label designs, the extensive use of non-final endpoints, and the limited use of patient-reported outcomes (PROs) are the main points of contention. The evidence on the actual design of these trials is limited, but corroborates the concerns of the above. Our aim is to scrutinise whether the design of pivotal studies of drugs for rare diseases to be launched into the Italian market by 2026 present similar issues. The drugs and the relevant pivotal studies were retrieved from Biomedtracker and US and European clinical trial databases. We identified 154 new drugs for rare diseases. Single-arm designs account for 36% of trials. Almost 50% of randomised control trials (RCTs) are designed using an active comparator and 61% are double-blinded. Primary endpoints are mostly (82%) surrogate. A total of 59% of studies include PROs. Our findings were partially expected (e.g., extensive use of surrogate endpoints) and partially not (e.g., RCTs and an active comparator), considering previous studies on the same topic. Having more head-to-head studies may reduce uncertainty concerning evidence at market launch, but different issues persist, including the still limited role of PROs. Full article

This study investigates the influence of monthly income level (low, medium, and high) on consumer behavior regarding a newly launched cream cheese product enriched with berry by-products. A panel of 345 participants was surveyed, and data were analyzed using the Kruskal–Wallis and Mann–Whitney tests. Most consumers were environmentally aware, recognizing the impact of personal food waste and expressing support for food products incorporating by-products. Respondents also favored the use of renewable energy and reducing greenhouse gas emissions in the food industry. Higher income levels were associated with greater health awareness and increased acceptance of cream cheese with berry by-products, with the high-income group showing a greater willingness to pay a premium. Health benefits and the product’s natural character were the main advantages identified. Individuals with lower incomes were more open to trying unfamiliar foods when ingredient details were not provided, while higher-income respondents expressed greater hesitation and distrust toward new products. Willingness to try novel items decreased with income level. Statistically significant differences (p < 0.05) were found between income groups for label reading, support for mountain dairies, and the influence of product origin, health benefits, nutrient diversity, pricing concerns, and consumer confidence in purchasing cream cheese with berry by-products. These findings are important for understanding how income affects consumer perceptions and willingness to consume innovative, sustainable food products like berry-enriched cream cheese, highlighting key areas for targeted marketing and product development. Full article

In an increasingly digitalized marketplace, understanding Generation Z’s (Gen Z) online consumer behavior has become a critical priority, particularly in relation to newly launched technological products. Although online consumer behavior has been widely studied, a gap remains in understanding how the location of the e-shop (domestic vs. international) moderates this behavior. Addressing this gap, the present study adopts a quantitative, cross-sectional design with data from 302 Gen Z participants, using a hybrid sampling method that combines convenience and systematic techniques. A structured questionnaire, grounded in 19 well-established behavioral theories, was employed to examine the influence of six key factors, behavioral and attitudinal traits, social and peer influences, marketing impact, online experience, brand perceptions, and Gen Z characteristics, across various stages of the consumer journey. Moderation analysis revealed that e-shop location significantly affects the strength of relationships between these factors and both purchase intention and post-purchase behavior. Notably, Gen Z’s values and marketing responsiveness were found to be more predictive in the context of international e-shops. These findings highlight the importance of marketing strategies that are both locally relevant and globally informed. For businesses, this research offers actionable insights into how digital engagement and brand messaging can be tailored to meet the unique expectations of Gen Z consumers across diverse e-commerce contexts, thereby enhancing consumer satisfaction, loyalty, and brand advocacy. Full article

Hybrid Propellant Rocket Motors (HPRMs) have been advancing rapidly in recent years. These improvements are finally increasing their competitiveness in the global launch-vehicle market. However, some topics, such as the pre-combustion chamber design, still require more in-depth studies. Few studies have examined this subject. This work proposes a low-computational-cost algorithm that calculates the minimum pre-combustion chamber length, with a vaporization and feed-system coupled instability model. This type of analysis is a key tool for minimizing a vehicle’s size, weight, losses, and costs. Additionally, coupling with internal ballistics codes can be implemented. Furthermore, the results were compared with real HPRMs to verify the algorithm’s reliability. The shortened pre-chamber architecture trimmed the inert mass and reduced the feed-system pressure requirement, boosting overall propulsive energy efficiency by $\approx 8\%$ relative to conventional L*-based designs. These gains can lower stored-gas enthalpy and reduce life-cycle CO and CO₂-equivalent emissions, strengthening the case for lighter and more sustainable access-to-space technologies. Full article

Premium fashion brands are increasingly adopting Generative Artificial Intelligence (GenAI) to reduce costs and enhance creativity. However, consumers have mixed perceptions of clothing with AI-generated patterns (CAGPs) launched by premium fashion brands, especially in online shopping contexts where consumers cannot examine physical products firsthand. This study integrates the Theory of Planned Behavior (TPB) with Customer Perceived Value (CPV) to investigate Chinese Millennials’ attitudes and purchase intentions toward online purchases of CAGPs launched by premium fashion brands. Using a purposive sampling approach, the study collected 471 valid responses from Chinese Millennials. Structural equation modeling (SEM) was then employed to test the proposed model and hypotheses. The results reveal that perceived brand design effort and perceived price value are primary drivers of purchase intention for CAGPs from premium fashion brands, while perceived aesthetic value significantly shapes consumer attitudes. The subjective norm and attitude positively influence purchase intention. This study sheds light on the roles of aesthetic, emotional, monetary and social factors in driving purchase intention, offering practical suggestions for premium brands’ product design and marketing strategies. Full article

This study examined the potential for developing community-based homestays in Nigeria. Community-based homestays are a sustainable form of tourism that has the capacity to promote the Sustainable Development Goals (SDGs). With its abundant natural and cultural resources, Nigeria has not yet fully utilized these potentials for community-based homestays, which could serve as a strategy for the sustainable development of local communities facing livelihood challenges. Stakeholder theory serves as the theoretical foundation for this study, particularly in its application to a nascent concept. We proposed a framework for effective tourism development in Nigeria, focusing on acceptability, feasibility, and potential outcomes. Qualitative research was conducted through focus group discussions (FDGs) with purposively selected tourism stakeholders, including academia, tour operators, NGOs, and local communities, and further analyzed thematically. The study emphasizes that embracing stakeholder theory rather than relying on a top-down approach is crucial for effectively addressing the varied concerns of key participants before launching community-based homestay tourism. This approach seeks to maximize benefits while minimizing challenges. The result shows that developing community-based homestay tourism in Nigeria is achievable if all stakeholders work together to create supportive tourism policies and agree on a collaborative management framework for the initiative. Furthermore, it is essential to consider the needs of residents by including them in the homestay management committee. Local communities should receive sufficient funding, and effective marketing strategies must be put in place to promote the initiative. To ensure acceptance of homestay tourism among local communities, it is vital to communicate its benefits to potential operators, respect local cultures, and guarantee that economic gains are shared fairly. Full article

Allergic rhinitis (AR) is a global health problem on the rise. More and more people are affected, and climate change is exacerbating this health problem in the long term. The quality of life of those affected is often severely compromised, and the financial burden on healthcare systems cannot be disregarded. Therefore, effective and safe medicines are needed to counteract this trend. P. hybridus (butterbur) leaf extract (Ze 339) displays a promising alternative to antihistamines in the treatment of AR symptoms. More than two decades after the first market launch it is now possible to draw a meaningful conclusion on its safety and efficacy. This review summarizes the available preclinical and clinical data, real-world data (RWD) as well as data from post-marketing pharmacovigilance monitoring about the herbal medicinal drug Ze 339. It focusses on the current knowledge about the mode of action as well as the evaluation of its efficacy and safety in the treatment of AR. Given its favourable safety profile and lack of sedative side effects, Ze 339 offers a valuable alternative to antihistamines and should therefore continue to be considered by medical practitioners for the treatment of allergic rhinitis symptoms. Full article

Background: The global space economy has grown remarkably, witnessing a 10-fold increase in active satellites during the last 15 years. This growth was accompanied by both the increase in geopolitical tensions feeding huge investments (the New Space Race), on the one hand, and the transformation, shifting from a domain historically dominated by government-led programs to one partially energized by commercial players and innovative business models (“New Space”), on the other hand. Objective: To assess the space economy’s current state and future prospects by considering its economic and social dimensions. Methods: Over 120 scholarly articles and “grey” literature positions (e.g., industry reports) were reviewed. The review was structured by a modified Structure–Conduct–Performance framework originally developed by industrial organization (IO) scholars. Findings: Outer space creates extremely harsh conditions for placing and operating objects in orbits, which results in high launching costs, steep reliability standards, capital intensity, and risks that are unmatched in most terrestrial industries. One of the main motivations to venture into this harsh domain was, and still is, the desire to dominate or the fear of being subjugated by others. This “original sin”, born of geopolitical rivalries, continues to cast a shadow over the space economy, channeling the majority of public space budgets into military-related programs. Moreover, many space technologies have a dual-use feature. Not surprisingly, governments are still the major source of demand, dominating midstream in the space value chain. This triad—harsh physics, great power rivalry, and a state-centric midstream—produces a specificity of the sector. In the recent two decades, new entrants (called “New Space”) have begun altering market structure, resulting in new conduct patterns focused on pursuits towards serial production, reusability, and lowering costs. Performance outcomes are mixed. While some efficiency gains are unprecedented, some doubts about market power and negative externalities arise. The assessment of the space economy’s performance is a challenge, as such, due to the blurred boundary between political objectives (supplying public goods, mitigating negative externalities) and economic optimization. Such trade-offs are becoming even more complicated considering the potential conflict between national and global perspectives. The paper offers a preliminary, descriptive study of the space economy through the lens of the modified S-C-P framework, laying basic foundations for the future, possibly more rigorous research of the increasingly important space economy. Full article

In the era of digital economy, the open sharing of public data elements has become a key engine driving the digital transformation of enterprises. This article is based on a quasi-natural experiment using government data platforms launched from 2011 to 2022, and it uses the asymptotic difference-in-differences method to empirically test the mechanism and impact of public data elements on enterprise digital transformation. It has been discovered that making data items publicly available dramatically increases the degree of enterprise digital transformation. According to mechanism analysis, corporate digital transformation is primarily impacted by releasing public data elements through two channels: information resource sharing and removing financial restraints. According to heterogeneity analysis, public data elements significantly impact enterprise digital transformation when they are located in regions with high data openness quality, when they are located in regions with substantial levels of digital economic vitality, and when they are available during businesses’ growth and maturity stages. The enabling influence of public data elements on organizational digital transformation was positively mitigated via a fully functional digital infrastructure and cutting-edge digital products. This study has confirmed the driving value of the market-oriented allocation of data elements in the digital transformation of enterprises, providing a theoretical basis for improving the government’s data openness system and unleashing the productivity of data elements. It also provides practical inspiration for enterprises to seize digital opportunities. Full article

Generation Z is emerging as a powerful force in shaping global consumer behavior, particularly in the market of digital and technological products. This study examines how specific branding dimensions, such as online brand experience, engagement, image, trust, loyalty, awareness, behavioral intention, and brand knowledge, influence Gen Z’s purchase intention, emphasizing sustainable consumption. Sustainable consumption, in this context, refers to the preference for tech products that minimize the environmental impact through eco-friendly design, energy efficiency, and responsible sourcing. Using a quantitative approach, this cross-sectional research explores the effects of online brand experience, engagement, image, trust, loyalty, awareness, behavioral intention, and knowledge on purchasing newly launched technological products that align with sustainability. Data were collected from a Gen Z sample using a combination of convenience and systematic sampling, and multiple regression analysis identified the most significant predictors of purchase intention. The results indicate that online brand experience, brand image, brand trust, and brand loyalty play the most crucial roles, having a greater effects on Gen Z’s purchase intention, while brand awareness and knowledge also contribute. However, brand engagement and behavioral intention have weaker effects. These findings suggest that brands targeting Gen Z should prioritize building a strong, trustworthy, and engaging online presence while highlighting their sustainability efforts, and when Gen Z consumers have favorable digital interactions with a brand, perceive its image positively, trust it, and feel loyal to it, they are more likely to consider purchasing its sustainable offerings. This study enhances the understanding of Gen Z’s consumer behavior and offers insights for businesses seeking to foster sustainable consumption by highlighting the importance of developing marketing strategies that strengthen online brand experience, cultivate trust and loyalty, and clearly communicate sustainability values, such as through engaging digital content, transparent messaging, and eco-conscious branding, to effectively foster sustainable consumption among this environmentally conscious and digitally driven generation. Full article

New dual-curing resin cements are constantly launched into the market to improve the bond strength between dentine and indirect restorations when light irradiation is limited by the restoration material. The present study evaluated the microshear bond strength (μSBS) of two dual-cured resin cements, Estecem II Plus (EP) and Variolink Esthetic DC (VAR), when resin composite or dentine substrates were conditioned with their corresponding universal adhesives, Tokuyama Universal Bond II (TUB) and Adhese Universal DC (ADH). The experimental groups (n = 20) were (1) TUB/EP light-cured, (2) TUB/EP self-cured, (3) ADH/VAR light-cured, and (4) ADH/VAR self-cured. A μSBS test was performed after 24 h (T0) or after thermocycling (TC), and failure modes were assessed. Data analysis was performed using three-way ANOVA and Tukey tests (p < 0.05). In composite, TUB/EP self-cured demonstrated the highest μSBS at T0 and TC. After TC, TUB/EP self-cured and ADH/VAR light-cured remained stable (p > 0.05). In dentine, TUB/EP light-cured was statistically superior to TUB/EP self-cured and ADH/VAR self-cured at T0. Thermocycling decreased the μSBS of light-curing groups. TUB/EP achieved optimal μSBS when the manufacturer’s instructions were followed and the adhesive was self-cured, irrespective of the bonding substrate. However, ADH/VAR was more dependent on the type of bonding substrate than on the curing mode of the resin cement. Full article

Recently, in the space market, there has been a rapid reduction in the launch price. The major reason for this is that a few commercial companies began to enter the space market about ten years ago, which has changed the space market from monopolization to competition and accelerated the adoption of commercial efficiency in technology and management. Also, SpaceX made a breakthrough by successfully recovering the first stage of its launch vehicle in 2016, thereby opening the door to reusable launch vehicles. They have declared their intention to significantly reduce satellite launch costs in the future by utilizing the potential of reusable launch vehicles. In this study, we calculate the total launch cost required to place a single satellite into Low Earth Orbit (LEO) and compare the launch costs for three different payload capacity scenarios, investigating how payload capacity affects the cost-effectiveness of reusable launch vehicles. The launch cost is broken down into development costs, production costs, reuse costs, operational costs, fixed costs, and insurance costs, with cost estimation equations utilized based on cost calculation models such as TRANSCOST. Full article

Urban agriculture is considered by many scientists and policymakers as a key strategy to build climate change-resilient communities within cities by strengthening food systems, with positive food security, biodiversity, nutrition and health outcomes. The estimated potential of urban agriculture to provide between 15 and 20% of the global food supply can be enhanced by applying agroecological principles and practices that revitalize urban agriculture cropping systems, thus leading to the design of highly diversified, productive and resilient urban farms on a planet in polycrisis. Two pillars are used in agroecology: (a) restoring spatial and temporal crop combinations that deter pests by enhancing biological control with natural enemies, and (b) increasing soil organic matter through green manures, compost and other organic practices that enhance soil fertility and beneficial microorganisms. In addition to technical and environmental obstacles, there are a series of social, economic and political barriers that limit the scaling-up of urban agriculture. For this reason, it is important to launch policies that establish mechanisms for cities to provide incentives for urban agriculture, including access to land, water, seeds and technical knowledge. The creation of producer–consumer networks around markets with solidarity is critical for local equitable food provision and consumption. Full article

The circular economy is considered the best principle through which sustainable practices may be established. Mineral exhaustion, decarbonisation, and waste elimination can all be addressed through a circular economy. The built environment is one of the largest waste producers and a significant user of materials such as concrete and steel. However, there are considerable barriers to the adoption of a circular economy. The objective of the study was to identify, examine, and comprehend the main challenges that impede the implementation and scaling of circular practices within the built environment. As part of the CircularB network, a questionnaire was launched in 2024 to gather opinions on the technical, political, regulatory, cultural, societal, economic, and market barriers to circular economy from built environment professionals. This paper focuses on the economic and market barriers, which were recognised as the most important according to the insights of 270 respondents. The hurdles investigated include extra costs of building insurance, inadequate collaboration, linear public procurement, unwillingness to take back used components, low awareness of exchange marketplaces, and market disconnection due to significant transport distances. Addressing these barriers plays a crucial role in advancing a circular built environment, and all stakeholders must explore solutions to overcome them. Full article

Tendon defect is one of the common clinical diseases related to the growing population mean age and the number of athletes. Due to an increasing demand for tendon repair surgical interventions, several tendon augmentation products, capable of guaranteeing the necessary biological and visco-elasticity properties and mechanical support, have been developed. In this regard, commercially available products may be grouped into three main categories: (i) natural, (ii) synthetic, and (iii) hybrid biomaterial-based products. Firstly, to better define the research area of this work, common search engines were employed to acquire information from reports or website portfolios of important competitors in the global tendon repair market. Secondly, public registries and bibliographic databases were also employed to analyse data from registered clinical trials and published clinical studies performed to evaluate the safety and efficacy of each product. Ten new products have been launched on the market in the last fifteen years: advantages, disadvantages, and future perspectives regarding their use for tendon augmentation treatment are discussed. Although hybrid biomaterial-based products may be considered as more oriented to the new frontiers of tendon augmentation technology, future improvements, especially focused on both mechanical properties and biocompatibility, are needed. However, scientific innovations must navigate convoluted clinical regulatory paths, which, due to high costs for investors, long development timelines, and funding shortages, hinder the translation of many scientific discoveries into routine clinical practice. Full article