An Overview of Technology Availability to Support Remote Decentralized Clinical Trials

Developing new medicine and health solutions and improving patient health currently rely on the successful execution of clinical trials, which generate relevant safety and efficacy data. For their success, recruitment and retention of participants are some of the most challenging aspects of protocol adherence. Main barriers include: i) lack of awareness of clinical trials; ii) long distance from the clinical site; iii) the burden on participants, including the duration and number of clinical visits, and iv) high dropout rate. Most of these aspects could be addressed with a new paradigm, namely the Remote Decentralized Clinical Trials (RDCTs). Furthermore, the COVID-19 pandemic has highlighted additional advantages and challenges for RDCTs in practice, allowing participants to join trials from home and not depending on site visits, etc. Nevertheless, RDCTs should follow the process and the quality assurance of conventional clinical trials, which involve several processes. For each part of the trial, the Building Blocks, existing software and technologies were assessed through a systematic search. The technology needed to perform RDCTs is widely available and validated but is yet segmented and developed in silos, as different software solutions address different parts of the trial and at various levels. The current paper is analyzing the availability of technology to perform RDCTs, identifying gaps and providing an overview of Basic Building Blocks and functionalities that need to be covered to support the described processes.

Physicochemical and Thermal Characterization of Starch from Three Different Plantain Cultivars in Puerto Rico

Plantain contains starch as the main component and represents a relevant source of this carbohydrate. Starches from different cultivars of plantain and bananas have been studied for industrialization purposes due to their morphological and thermal characteristics and their influence in food products. This study aimed to characterize the physical, chemical, and thermal properties of starch from three different plantain cultivated in Puerto Rico: Maricongo, Maiden and FHIA 20. Amylose and amylopectin content, color, granular size, morphology, and thermal properties were determined. According to the amylose content in starches, FHIA 20 presented lowest content of the three cultivars studied. In terms of color, Maiden and FHIA 20 starches exhibited significantly higher whiteness indexes compared to Maricongo starch. Starches of the three cultivars had an elongated-ovoid morphology, with a smooth surface and a non-porous appearance. Regardless of similarities in their morphology, FHIA 20 exhibited a lower aspect ratio since its granules tended to be more elongated. Comparison of the thermal properties of starches showed that initial starch gelatinization temperature was similar among cultivars. However, FHIA 20 starch presented a noticeably higher final gelatinization temperature (87.95°C) and transition enthalpy than Maricongo (79.69°C) and Maiden (77.40°C). Despite similarities, starches from plantain cultivars showed differences in their composition and thermal behavior. This represents an opportunity to diversify plantain starch use in food-related applications.

Hematologic Inflammatory Markers and Inflammation-Related Hepatokines in Pediatric Obesity

Obesity in children particularly draws attention, because it may threaten the individual’s future life due to many chronic diseases it may lead to. Most of these diseases including obesity itself altogether are related to inflammation. For this reason, inflammation-related parameters gain importance. Within this context, complete blood cell counts, ratios or indices derived from these counts have recently found some platform to be used as inflammatory markers. So far, mostly adipokines were investigated within the field of obesity. Metabolic inflammation is closely associated with cellular dysfunction. In this study, hematologic inflammatory markers and cytokines produced predominantly by the liver (fibroblast growth factor-21 (FGF-21) and fetuin A) were investigated in pediatric obesity. Two groups were constituted from 76 obese children based on World Health Organization criteria. Group 1 was composed of children, whose age- and sex-adjusted body mass index (BMI) percentiles were between 95 and 99. Group 2 consists of children, who are above 99th percentile. The first and the latter groups were defined as obese (OB) and morbid obese (MO). Anthropometric measurements of the children were performed. Informed consent forms and the approval of the institutional ethics committee were obtained. Blood cell counts and ratios were determined by automated hematology analyzer. The related ratios and indexes were calculated. Statistical evaluation of the data was performed by SPSS program. There was no statistically significant difference in terms of neutrophil-to lymphocyte ratio, monocyte-to-high density lipoprotein cholesterol ratio and platelet-to-lymphocyte ratio between the groups. Mean platelet volume and platelet distribution width values were decreased (p < 0.05), total platelet count, red cell distribution width (RDW) and systemic immune inflammation index values were increased (p < 0.01) in MO group. Both hepatokines were increased in the same group, however increases were not statistically significant. In this group, also a strong correlation was calculated between FGF-21 and RDW when controlled by age, hematocrit, iron and ferritin (r = 0.425; p < 0.01). In conclusion, the association between RDW, a hematologic inflammatory marker, and FGF-21, an inflammation-related hepatokine, found in MO group is an important finding discriminating between OB and MO children. This association is even more powerful when controlled by age and iron-related parameters.

Parameters Influencing Human-Machine Interaction in Hospitals

Handling life-critical systems complexity requires to be equipped with appropriate technology and the right human agents’ functions such as knowledge, experience, and competence in problem’s prevention and solving. Human agents are involved in the management and control of human-machine system’s performance. Documenting human agent’s situation awareness is crucial to support human-machine designers’ decision-making. Knowledge about risks, critical parameters and factors that can impact and threaten automation system’s performance should be collected using preventive and retrospective approaches. This paper aims to document operators’ situation awareness through the analysis of automated organizations’ feedback. The analysis of automated hospital pharmacies feedback helps identify and control critical parameters influencing human machine interaction in order to enhance system’s performance and security. Our human machine system evaluation approach has been deployed in Macon hospital center’s pharmacy which is equipped with automated drug dispensing systems since 2015. Automation’s specifications are related to technical aspects, human-machine interaction, and human aspects. The evaluation of drug delivery automation performance in Macon hospital center has shown that the performance of the automated activity depends on the performance of the automated solution chosen, and also on the control of systemic factors. In fact, 80.95% of automation specification related to the chosen Sinteco’s automated solution is met. The performance of the chosen automated solution is involved in 28.38% of automation specifications performance in Macon hospital center. The remaining systemic parameters involved in automation specifications performance need to be controlled. 

Automated 3D Segmentation System for Detecting Tumor and Its Heterogeneity in Patients with High Grade Ovarian Epithelial Cancer

High grade ovarian epithelial cancer (OEC) is the most fatal gynecological cancer and poor prognosis of this entity is closely related to considerable intratumoral genetic heterogeneity. By examining imaging data, it is possible to assess the heterogeneity of tumorous tissue. This study presents a methodology for aligning, segmenting and finally visualizing information from various magnetic resonance imaging series, in order to construct 3D models of heterogeneity maps from the same tumor in OEC patients. The proposed system may be used as an adjunct digital tool by health professionals for personalized medicine, as it allows for an easy visual assessment of the heterogeneity of the examined tumor.