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Authors: Shilpa Murthy, Hazlina Binti Abu Bakar, Juliet Mathew, Chandrashekhar Thummala Hlly Sreerama Reddy, Pathiyil Ravi Shankar

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Simulation is defined as a technique that replaces or expands real experiences with guided experiences that interactively imitate real-world processes or systems. Simulation enables learners to train in a safe and non-threatening environment. For decades, simulation has been considered an integral part of clinical teaching and learning strategy in medical education. The several types of simulation used in medical education and the clinical environment can be applied to several models, including full-body mannequins, task trainers, standardized simulated patients, virtual or computer-generated simulation, or Hybrid simulation that can be used to facilitate learning. Simulation allows healthcare practitioners to acquire skills and experience while taking care of patient safety. The recent COVID pandemic has also led to an increase in simulation use, as there were limitations on medical student placements in hospitals and clinics. The learning is tailored according to the educational needs of students to make the learning experience more valuable. Simulation in the pre-clinical years has challenges with resource constraints, effective curricular integration, student engagement and motivation, and evidence of educational impact, to mention a few. As instructors, we may have more reliance on the use of simulation for pre-clinical students while the students’ confidence levels and perceived competence are to be evaluated. Our research question was whether the implementation of simulation-based learning positively influences preclinical medical students' confidence levels and perceived competence. This study was done to align the teaching activities with the student’s learning experience to introduce more low-fidelity simulation-based teaching sessions for pre-clinical years and to obtain students’ input into the curriculum development as part of inclusivity. The study was carried out at International Medical University, involving pre-clinical year (Medical) students who were started with low-fidelity simulation-based medical education from their first semester and were gradually introduced to medium fidelity, too. The Student Satisfaction and Self-Confidence in Learning Scale questionnaire from the National League of Nursing was employed to collect the responses. The internal consistency reliability for the survey items was tested with Cronbach’s alpha using an Excel file. IBM SPSS for Windows version 28.0 was used to analyze the data. Spearman’s rank correlation was used to analyze the correlation between students’ satisfaction and self-confidence in learning. The significance level was set at p value less than 0.05. The results from this study have prompted the researchers to undertake a larger-scale evaluation, which is currently underway. The current results show that 70% of students agreed that the teaching methods used in the simulation were helpful and effective. The sessions are dependent on the learning materials that are provided and how the facilitators engage the students and make the session more enjoyable. The feedback provided inputs on the following areas to focus on while designing simulations for pre-clinical students. There are quality learning materials, an interactive environment, motivating content, skills and knowledge of the facilitator, and effective feedback.

Keywords: low-fidelity simulation, pre-clinical simulation, students satisfaction, self-confidence

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Authors: Sharon Harel, Rachel Kizony, Yoram Feldman, Gabi Zeilig, Mordechai Shani

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Multiple Sclerosis (MS) is a neurological disease that may cause restriction in participation in daily activities of young adults. Main symptoms include fatigue, weakness and cognitive decline. The appearance of symptoms, their severity and deterioration rate, change between patients. The challenge of health services is to provide long-term rehabilitation services to people with MS. The objective of this presentation is to describe a course of tele-rehabilitation service of a woman with MS. Methods; R is a 48 years-old woman, diagnosed with MS when she was 22. She started to suffer from weakness of her non-dominant left upper extremity about ten years after the diagnosis. She was referred to the tele-rehabilitation service by her rehabilitation team, 16 years after diagnosis. Her goals were to improve ability to use her affected upper extremity in daily activities. On admission her score in the Mini-Mental State Exam was 30/30. Her Fugl-Meyer Assessment (FMA) score of the left upper extremity was 48/60, indicating mild weakness and she had a limitation of her shoulder abduction (90 degrees). In addition, she reported little use of her arm in daily activities as shown in her responses to the Motor Activity Log (MAL) that were equal to 1.25/5 in amount and 1.37 in quality of use. R. received two 30 minutes on-line sessions per week in the tele-rehabilitation service, with the CogniMotion system. These were complemented by self-practice with the system. The CogniMotion system provides a hybrid (synchronous-asynchronous), the home-based tele-rehabilitation program to improve the motor, cognitive and functional status of people with neurological deficits. The system consists of a computer, large monitor, and the Microsoft’s Kinect 3D sensor. This equipment is located in the client’s home and connected to a clinician’s computer setup in a remote clinic via WiFi. The client sits in front of the monitor and uses his body movements to interact with games and tasks presented on the monitor. The system provides feedback in the form of ‘knowledge of results’ (e.g., the success of a game) and ‘knowledge of performance’ (e.g., alerts for compensatory movements) to enhance motor learning. The games and tasks were adapted for R. motor abilities and level of difficulty was gradually increased according to her abilities. The results of her second assessment (after 35 on-line sessions) showed improvement in her FMA score to 52 and shoulder abduction to 140 degrees. Moreover, her responses to the MAL indicated an increased amount (2.4) and quality (2.2) of use of her left upper extremity in daily activities. She reported high level of enjoyment from the treatments (5/5), specifically the combination of cognitive challenges while moving her body. In addition, she found the system easy to use as reflected by her responses to the System Usability Scale (85/100). To-date, R. continues to receive treatments in the tele-rehabilitation service. To conclude, this case report shows the potential of using tele-rehabilitation for people with MS to provide strategies to enhance the use of the upper extremity in daily activities as well as for maintaining motor function.

Keywords: motor function, multiple-sclerosis, tele-rehabilitation, daily activities

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Authors: Lazzat M. Zhamaliyeva, Nurgul A. Abenova, Gauhar S. Dilmagambetova, Ziyash Zh. Tanbetova, Moldir B. Ahmetzhanova, Tatyana P. Ostretcova, Aliya A. Yegemberdiyeva

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Introduction: There are many reasons for the weak training of family doctors in Kazakhstan: the unified national educational program is not focused on competencies, the role of a general practitioner (GP) is not clear, poor funding for the health care and education system, outdated teaching and assessment methods, inefficient management. We highlight two issues in particular. Firstly, academic teachers of family medicine (FM) in Kazakhstan do not practice as family doctors; most of them are narrow specialists (pediatricians, therapists, surgeons, etc.); they usually hold one-time consultations; clinical mentors from practical healthcare (non-academic teachers) do not have the teaching competences, and the vast majority of them are also narrow specialists. Secondly, clinical sites (polyclinics) are unprepared for general practice and do not follow the principles of family medicine; residents do not like to be in primary health care (PHC) settings due to the chaos that is happening there, as well as due to the lack of the necessary equipment for mastering and consolidating practical skills. Aim: We present the concept of the family physicians’ training office (FPTO), which is being created as a friendly learning environment for young general practitioners and for the involvement of academic teachers of family medicine in the practical work and innovative development of PHC. Methodology: In developing the conceptual framework and identifying practical activities, we drew on literature and expert input, and interviews. Results: The goal of the FPTO is to create a favorable educational and clinical environment for the development of the FM residents’ competencies, in which the residents with academic teachers and clinical mentors could understand and accept the principles of family medicine, improve clinical knowledge and skills, and gain experience in improving the quality of their practice in scientific basis. Three main areas of office activity are providing primary care to the patients, improving educational services for FM residents and other medical workers, and promoting research in PHC and innovations. The office arranges for residents to see outpatients at least 50% of the time, and teachers of FM departments at least 1/4 of their working time conduct general medical appointments next to residents. Taking into account the educational and scientific workload, the number of attached population for one GP does not exceed 500 persons. The equipment of the office allows FPTO workers to perform invasive and other manipulations without being sent to other clinics. In the office, training for residents is focused on their needs and aimed at achieving the required level of competence. International methodologies and assessment tools are adapted to local conditions and evaluated for their effectiveness and acceptability. Residents and their faculty actively conduct research in the field of family medicine. Conclusions: We propose to change the learning environment in order to create teams of like-minded people, to unite residents and teachers even more for the development of family medicine. The offices will also invest resources in developing and maintaining young doctors' interest in family medicine.

Keywords: educational environment, family medicine residents, family physicians’ training office, primary care research

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Authors: Asma Ben Hmidene, Mizuho Hanaki, Kazuma Murakami, Kazuhiro Irie, Hiroko Isoda, Hideyuki Shigemori

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Type 2 diabetes mellitus (T2DM) and Alzheimer’s disease (AD) are characterized as a peripheral metabolic disorder and a degenerative disease of the central nervous system, respectively. It is now widely recognized that T2DM and AD share many pathophysiological features including glucose metabolism, increased oxidative stress and amyloid aggregation. Amyloid beta (Aβ) is the components of the amyloid deposits in the AD brain and while the component of the amyloidogenic peptide deposit in the pancreatic islets of Langerhans is identified as human islet amyloid polypeptide (hIAPP). These two proteins are originated from the amyloid precursor protein and have a high sequence similarity. Although the amino acid sequences of amyloidogenic proteins are diverse, they all adopt a similar structure in aggregates called cross-beta-spine. Add at that, extensive studies in the past years have found that like Aβ1-42, IAPP forms early intermediate assemblies as spherical oligomers, implicating that these oligomers possess a common folding pattern or conformation. These similarities can be used in the search for effective pharmacotherapy for DM, since potent therapeutic agents such as antioxidants with a catechol moiety, proved to inhibit Aβ aggregation, may play a key role in the inhibit the aggregation of hIAPP treatment of patients with DM. Tamarix gallica is one of the halophyte species having a powerful antioxidant system. Although it was traditionally used for the treatment of various liver metabolic disorders, there is no report about the use of this plant for the treatment or prevention of T2DM and AD. Therefore, the aim of this work is to investigate their protective effect towards T2DM and AD by isolation and identification of α-glucosidase inhibitors, with antioxidant potential, that play an important role in the glucose metabolism in diabetic patient, as well as, the polymerization of hIAPP and Aβ aggregation inhibitors. Structure-activity relationship study was conducted for both assays. And as for α-glucosidase inhibitors, their mechanism of action and their synergistic potential when applied with a very low concentration of acarbose were also suggesting that they can be used not only as α-glucosidase inhibitors but also be combined with established α-glucosidase inhibitors to reduce their adverse effect. The antioxidant potential of the purified substances was evaluated by DPPH and SOD assays. Th-T assay using 42-mer amyloid β-protein (Aβ42) for AD and hIAPP which is a 37-residue peptide secreted by the pancreatic β –cells for T2DM and Transmission electronic microscopy (TEM) were conducted to evaluate the amyloid aggragation of the actives substances. For α-glucosidase, p-NPG and glucose oxidase assays were performed for determining the inhibition potential and structure-activity relationship study. The Enzyme kinetic protocol was used to study the mechanism of action. From this research, it was concluded that polyphenols playing a role in the glucose metabolism and oxidative stress can also inhibit the amyloid aggregation, and that substances with a catechol and glucuronide moieties inhibiting amyloid-β aggregation, might be used to inhibit the aggregation of hIAPP.

Keywords: α-glucosidase inhibitors, amyloid aggregation inhibition, mechanism of action, polyphenols, structure activity relationship, synergistic potential, tamarix gallica

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Authors: Vitaliy Petrov, Natalia Shusharina, Vitaliy Kasymov, Maksim Patrushev, Evgeny Bogdanov

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The leading worldwide death reasons are ischemic heart disease and other cardiovascular illnesses. Generally, the common symptom is high blood pressure. Long-time blood pressure control is very important for the prophylaxis, correct diagnosis and timely therapy. Non-invasive methods which are based on Korotkoff sounds are impossible to apply often and for a long time. Implantable devices can combine longtime monitoring with high accuracy of measurements. The main purpose of this work is to create a real-time monitoring system for decreasing the death rate from cardiovascular diseases. These days implantable electronic devices began to play an important role in medicine. Usually implantable devices consist of a transmitter, powering which could be wireless with a special made battery and measurement circuit. Common problems in making implantable devices are short lifetime of the battery, big size and biocompatibility. In these work, blood pressure measure will be the focus because it’s one of the main symptoms of cardiovascular diseases. Our device will consist of three parts: the implantable pressure sensor, external transmitter and automated workstation in a hospital. The Implantable part of pressure sensors could be based on piezoresistive or capacitive technologies. Both sensors have some advantages and some limitations. The Developed circuit is based on a small capacitive sensor which is made of the technology of microelectromechanical systems (MEMS). The Capacitive sensor can provide high sensitivity, low power consumption and minimum hysteresis compared to the piezoresistive sensor. For this device, it was selected the oscillator-based circuit where frequency depends from the capacitance of sensor hence from capacitance one can calculate pressure. The external device (transmitter) used for wireless charging and signal transmission. Some implant devices for these applications are passive, the external device sends radio wave signal on internal LC circuit device. The external device gets reflected the signal from the implant and from a change of frequency is possible to calculate changing of capacitance and then blood pressure. However, this method has some disadvantages, such as the patient position dependence and static using. Developed implantable device doesn’t have these disadvantages and sends blood pressure data to the external part in real-time. The external device continuously sends information about blood pressure to hospital cloud service for analysis by a physician. Doctor’s automated workstation at the hospital also acts as a dashboard, which displays actual medical data of patients (which require attention) and stores it in cloud service. Usually, critical heart conditions occur few hours before heart attack but the device is able to send an alarm signal to the hospital for an early action of medical service. The system was tested with wireless charging and data transmission. These results can be used for ASIC design for MEMS pressure sensor.

Keywords: MEMS sensor, RF power, wireless data, oscillator-based circuit

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Authors: Anna Bjällmark, Victoria Persson, Bodil Karlsson, May Bazzi

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Introduction: Interventional radiology (IR) is a continuously growing discipline that allows minimally invasive treatments of various medical conditions. The IR environment is, in several ways, comparable to the complex and accident-prone operation room (OR) environment. This implies that the IR environment may also be associated with various types of risks related to the work process and communication in the team. Patient safety is a central aspect of healthcare and involves the prevention and reduction of adverse events related to patient care. To maintain patient safety, it is crucial to build a safety culture where the staff are encouraged to report events and incidents that may have affected patient safety. It is also important to continuously evaluate the staff´s attitudes to patient safety. Despite the increasing number of IR procedures, research on the staff´s view regarding patients is lacking. Therefore, the main aim of the study was to describe and compare the IR team members' attitudes to patient safety. The secondary aim was to evaluate whether the WHO safety checklist was routinely used for IR procedures. Methods: An electronic survey was distributed to 25 interventional units in Sweden. The target population was the staff working in the IR team, i.e., physicians, radiographers, nurses, and assistant nurses. A modified version of the Safety Attitudes Questionnaire (SAQ) was used. Responses from 19 of 25 IR units (44 radiographers, 18 physicians, 5 assistant nurses, and 1 nurse) were received. The respondents rated their level of agreement for 27 items related to safety culture on a five-point Likert scale ranging from “Disagree strongly” to “Agree strongly.” Data were analyzed statistically using SPSS. The percentage of positive responses (PPR) was calculated by taking the percentage of respondents who got a scale score of 75 or higher. The respondents rated which corresponded to response options “Agree slightly” or “Agree strongly”. Thus, average scores ≥ 75% were classified as “positive” and average scores < 75% were classified as “non-positive”. Findings: The results indicated that the IR team had the highest factor scores and the highest percentages of positive responses in relation to job satisfaction (90/94%), followed by teamwork climate (85/92%). In contrast, stress recognition received the lowest ratings (54/25%). Attitudes related to these factors were relatively consistent between different professions, with only a few significant differences noted (Factor score: p=0.039 for job satisfaction, p=0.050 for working conditions. Percentage of positive responses: p=0.027 for perception of management). Radiographers tended to report slightly lower values compared to other professions for these factors (p<0.05). The respondents reported that the WHO safety checklist was not routinely used at their IR unit but acknowledged its importance for patient safety. Conclusion: This study reported high scores concerning job satisfaction and teamwork climate but lower scores concerning perception of management and stress recognition indicating that the latter are areas of improvement. Attitudes remained relatively consistent among the professions, but the radiographers reported slightly lower values in terms of job satisfaction and perception of the management. The WHO safety checklist was considered important for patient safety.

Keywords: interventional radiology, patient safety, safety attitudes questionnaire, WHO safety checklist

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Authors: Huan Peng, Chenye Zeng, Zhao Wang

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Alzheimer’s disease (AD) is an age-related neurodegenerative disease that is a leading cause of dementia syndromes and has become a huge burden on society and families. The main pathological features of AD involve excessive deposition of β-amyloid (Aβ) and Tau proteins in the brain, resulting in loss of neurons, expansion of neuroinflammation, and cognitive dysfunction in patients. Researchers have found effective drugs to clear the brain of error-accumulating proteins or to slow the loss of neurons, but their direct administration has key bottlenecks such as single-drug limitation, rapid blood clearance rate, impenetrable blood-brain barrier (BBB), and poor ability to target tissues and cells. Therefore, we are committed to seeking a suitable and efficient delivery system. Inspired by the possibility that exosomes may be involved in the secretion and transport mechanism of many signaling molecules or proteins in the brain, exosomes have attracted extensive attention as natural nanoscale drug carriers. We selected exosomes derived from bone marrow mesenchymal stem cells (MSC-EXO) with low immunogenicity and exosomes derived from hippocampal neurons (HT22-EXO) that may have excellent homing ability to overcome the deficiencies of oral or injectable pathways and bypass the BBB through nasal administration and evaluated their delivery ability and effect on AD. First, MSC-EXO and HT22 cells were isolated and cultured, and MSCs were identified by microimaging and flow cytometry. Then MSC-EXO and HT22-EXO were obtained by gradient centrifugation and qEV SEC separation column, and a series of physicochemical characterization were performed by transmission electron microscope, western blot, nanoparticle tracking analysis and dynamic light scattering. Next, exosomes labeled with lipophilic fluorescent dye were administered to WT mice and APP/PS1 mice to obtain fluorescence images of various organs at different times. Finally, APP/PS1 mice were administered intranasally with two exosomes 20 times over 40 days and 20 μL each time. Behavioral analysis and pathological section analysis of the hippocampus were performed after the experiment. The results showed that MSC-EXO and HT22-EXO were successfully isolated and characterized, and they had good biocompatibility. MSC-EXO showed excellent brain enrichment in APP/PS1 mice after intranasal administration, could improve the neuronal damage and reduce inflammation levels in the hippocampus of APP/PS1 mice, and the improvement effect was significantly better than HT22-EXO. However, intranasal administration of the two exosomes did not cause depression and anxious-like phenotypes in APP/PS1 mice, nor significantly improved the short-term or spatial learning and memory ability of APP/PS1 mice, and had no significant effect on the content of Aβ plaques in the hippocampus, which also meant that MSC-EXO could use their own advantages in combination with other drugs to clear Aβ plaques. The possibility of realizing highly effective non-invasive synergistic treatment for AD provides new strategies and ideas for clinical research.

Keywords: Alzheimer’s disease, exosomes derived from mesenchymal stem cell, intranasal administration, therapy-carrier dual roles

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Authors: Kari Björn

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Introduction of games has expanded the application area of computer-aided learning tools to wide variety of age groups of learners. Serious games engage the learners into a real-world -type of simulation and potentially enrich the learning experience. Institutional background of a Bachelor’s level engineering program in Information and Communication Technology is introduced, with detailed focus on one of its majors, Health Technology. As part of a Customer Oriented Software Application thematic semester, one particular course of “eHealth Business and Solutions” is described and reflected in a gamified framework. Learning a consistent view into vast literature of business management, strategies, marketing and finance in a very limited time enforces selection of topics relevant to the industry. Health Technology is a novel and growing industry with a growing sector in consumer wearable devices and homecare applications. The business sector is attracting new entrepreneurs and impatient investor funds. From engineering education point of view the sector is driven by miniaturizing electronics, sensors and wireless applications. However, the market is highly consumer-driven and usability, safety and data integrity requirements are extremely high. When the same technology is used in analysis or treatment of patients, very strict regulatory measures are enforced. The paper introduces a course structure using gamification as a tool to learn the most essential in a new market: customer value proposition design, followed by a market entry game. Students analyze the existing market size and pricing structure of eHealth web-service market and enter the market as a steering group of their company, competing against the legacy players and with each other. The market is growing but has its rules of demand and supply balance. New products can be developed with an R&D-investment, and targeted to market with unique quality- and price-combinations. Product cost structure can be improved by investing to enhanced production capacity. Investments can be funded optionally by foreign capital. Students make management decisions and face the dynamics of the market competition in form of income statement and balance sheet after each decision cycle. The focus of the learning outcome is to understand customer value creation to be the source of cash flow. The benefit of gamification is to enrich the learning experience on structure and meaning of financial statements. The paper describes the gamification approach and discusses outcomes after two course implementations. Along the case description of learning challenges, some unexpected misconceptions are noted. Improvements of the game or the semi-gamified teaching pedagogy are discussed. The case description serves as an additional support to new game coordinator, as well as helps to improve the method. Overall, the gamified approach has helped to engage engineering student to business studies in an energizing way.

Keywords: engineering education, integrated curriculum, learning experience, learning outcomes

Procedia PDF Downloads 239

Authors: K. Power, M. White, B. Dunleavey, E. Comerford, C. Doherty, N. Delanty, R. Corbridge, M. Fitzsimons

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Introduction: Providing people with access to their own healthcare information and engaging them as co-authors of their health record can promote better transparency, trust, and inclusivity in the healthcare system. With the advent of electronic health records, there is a move towards involving patients as partners in their healthcare by providing them with access to their own health data via electronic patient portals (ePortal). For example, a recently developed ePortal to the Irish National Epilepsy Electronic Patient Record (EPR) provides access to summary medical records, tools for Patient Reported Outcomes (PROM), health goal-setting and preparation for clinical appointments. Aim: To determine what people with epilepsy (their families/carers) value about the Irish epilepsy ePortal. Methods: A socio-technical process was employed recruiting 30 families of people with epilepsy who also have an intellectual disability (ID). Family members who are a care partner of the person with epilepsy (PWE) were invited to co-design, develop and implement the ePortal. Family members engaged in usability and utility testing which involved a face to face meeting to learn about the ePortal, register for a user account and evaluate its structure and content. Family members were instructed to login to the portal on at least two separate occasions following the meeting and to complete a self-report evaluation tool during this time. The evaluation tool, based on a Usability Questionnaire (Lewis, 1993), consists of a short assessment of comfort using technology, instructions for using the ePortal and some tasks to complete. Tasks included validating summary record details, assessing ePortal ease of use, evaluation of information presented. Participants were asked for suggestions on how to improve the portal and make it more applicable to PWE who also have an ID. Results: Family members responded positively to the ePortal and valued the ability to share information between clinicians and care partners; use the ePortal as a passport between different healthcare settings (e.g., primary care to hospital). In the context of elderly parents of PWE, the ePortal is valued as a tool for supporting shared care between family members. Participants welcomed the facility to log lists of questions and goals to discuss with the clinician at the next clinical appointment as a means of improving quality of care. Participants also suggested further enhancements to the ePortal such as access to clinic letters which can provide an aide memoir in terms of the careplan agreed with the clinical team. For example, through the ePortal, people could see what investigations or therapies are scheduled. Conclusion: The Epilepsy Patient Portal is accessible via a range of devices such as smartphones and tablets. ePortals have the potential to help personalise care, improve patient involvement in clinical decision making, engage them as quality and safety partners, and help clinicians be more responsive to patient needs. Acknowledgement: The epilepsy ePortal project is part of PISCES, a Lighthouse Project funded by eHealth Ireland and HSE to help build an understanding of the benefits of eHealth technologies in the Irish Healthcare System.

Keywords: electronic patient portal, electronic patient record, epilepsy, intellectual disability, usability testing

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Authors: Ananya Hazare, Ranjit Kamble

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Introduction: Patients with Cleft lip and palate (CL/P) can present with a maxillary retrution after cleft repair. Anterior Maxillary distraction osteogenesis (AMD) is a technique that provides simultaneous skeletal advancement and expansion of the soft tissues related to an anterior segment of the maxilla. This case presented is a case of AMD. The advantage of this technique is that the occlusion in the posterior segment can be maintained, and only the segment in cross bite is advanced for correction of the midfacial deficiency. The other alternative treatment is anterior movement by a Lefort 1 osteotomy. When a Lefort 1 osteotomy is compared with the Distraction osteogenesis or AMD, the disadvantages of the Le Fort 1 include a higher risk of morbidity, requirement of fixation, relapse tendency and unexpected changes in the nasal form. These complications were eliminated by AMD technique. This was followed by placement of the implant in the bone formed after AMD. Hence complete surgical, orthodontic and prosthodontics rehabilitation of the patient was done by an interdisciplinary approach. Methods: Patient presented with repaired UCL/P of the right side with midfacial retrusion. Intro-oral examination revealed a good occlusion in the posterior arch and anterior Crossbite from canine to canine. Patient's both maxillary lateral incisors were missing. The lower arch was well aligned with all teeth present. The study models when scored according to GOSLON yardstick received a score of 4. After pre-surgical orthodontic phase was completed an intraoral distractor was fabricated by modification of HYRAX expansion screw. After surgery, low subapical osteotomy cuts were placed and the distractor was fixed. The latency period of 5 days was observed after which the distraction was started. Distraction was done at a rate of 1 mm/day with a rhythm of 0.5mm in morning and 0.5mm in the evening. The total distraction of 12 mm was done. After a consolidation period, the distractor was removed, and retention by a removable partial denture was given. Radiographic examination confirmed mature bone formation in the distracted segment. Implants were placed and allowed to osseointegrate for approximately 4 months and were then loaded with abutments. Results: Total distraction done was 12mm and after relapse it was 8mm. After consolidation phase the radiographic examination revealed a B2 quality of bone according to the Misch's classification and sufficient height from the maxillary sinus. These findings were indicative for placement of implants in the distracted bone formed in premolar region. Implants were placed and after radiographic evidence of osseointegration was seen they were loaded with abutments. Thus resulting in a complete rehabilitation of a cleft patient by an interdisciplinary approach. Conclusion: Anterior maxillary distraction can be used as an alternative method instead of complete distraction osteogenesis or Lefort 1 advancement of maxilla in cases where the advancement needed is minimum. Use of HYRAX expansion screw modified as intra-oral distractor can be used in such cases, which significantly reduces the cost of treatment, as expensive distractors are not used. This technique is very useful and efficient in countries like India where the patient cannot afford expensive treatment options.

Keywords: cleft lip and palate, distraction osteogenesis, anterior maxillary distraction, orthodontics and dentofacial orthopaedics, hyrax expansion screw modification

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Authors: Kaushikk Iyer, Richard M Hall, David Keeling

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Hardware-in-the-loop (HIL) simulation is an advanced technique for developing and testing complex real-time control systems. This paper presents the benefits of HIL simulation and how it can be implemented and used effectively to develop, test, and validate advanced control algorithms used in a spinal joint Wear simulator for the Tribological testing of spinal disc prostheses. spinal wear simulator is technologically the most advanced machine currently employed For the in-vitro testing of newly developed spinal Discimplants. However, the existing control techniques, such as a simple position control Does not allow the simulator to test non-sinusoidal waveforms. Thus, there is a need for better and advanced control methods that can be developed and tested Rigorouslybut safely before deploying it into the real simulator. A benchtop HILsetupis was created for experimentation, controller verification, and validation purposes, allowing different control strategies to be tested rapidly in a safe environment. The HIL simulation aspect in this setup attempts to replicate similar spinal motion and loading conditions. The spinal joint wear simulator containsa four-Barlinkpowered by electromechanical actuators. LabVIEW software is used to design a kinematic model of the spinal wear Simulator to Validatehow each link contributes towards the final motion of the implant under test. As a result, the implant articulates with an angular motion specified in the international standards, ISO-18192-1, that define fixed, simplified, and sinusoid motion and load profiles for wear testing of cervical disc implants. Using a PID controller, a velocity-based position control algorithm was developed to interface with the benchtop setup that performs HIL simulation. In addition to PID, a fuzzy logic controller (FLC) was also developed that acts as a supervisory controller. FLC provides intelligence to the PID controller by By automatically tuning the controller for profiles that vary in amplitude, shape, and frequency. This combination of the fuzzy-PID controller is novel to the wear testing application for spinal simulators and demonstrated superior performance against PIDwhen tested for a spectrum of frequency. Kaushikk Iyer is a Ph.D. Student at the University of Leeds and an employee at Key Engineering Solutions, Leeds, United Kingdom, (e-mail: [email protected], phone: +44 740 541 5502). Richard M Hall is with the University of Leeds, the United Kingdom as a professor in the Mechanical Engineering Department (e-mail: [email protected]). David Keeling is the managing director of Key Engineering Solutions, Leeds, United Kingdom (e-mail: [email protected]). Results obtained are successfully validated against the load and motion tolerances specified by the ISO18192-1 standard and fall within limits, that is, ±0.5° at the maxima and minima of the motion and ±2 % of the complete cycle for phasing. The simulation results prove the efficacy of the test setup using HIL simulation to verify and validate the accuracy and robustness of the prospective controller before its deployment into the spinal wear simulator. This method of testing controllers enables a wide range of possibilities to test advanced control algorithms that can potentially test even profiles of patients performing various dailyliving activities.

Keywords: Fuzzy-PID controller, hardware-in-the-loop (HIL), real-time simulation, spinal wear simulator

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Authors: Yi H. Wong, Li L. Chan, Chee O. Leong, Stephen Ambu, Joon W. Mak, Priyadashi S. Sahu

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Background: Acanthamoeba is a free-living opportunistic protist which is ubiquitously distributed in the environment. Virulent Acanthamoeba can cause fatal encephalitis in immunocompromised patients and potential blinding keratitis in immunocompetent contact lens wearers. Approximately 24 species have been identified but only the A. castellanii, A. polyphaga and A. culbertsoni are commonly associated with human infections. Until to date, the precise molecular basis for Acanthamoeba pathogenesis remains unclear. Previous studies reported that Acanthamoeba virulence can be diminished through prolonged axenic culture but revived through serial mouse passages. As no clear explanation on this reversible pathogenesis is established, hereby, we postulate that the epigenetic regulators, DNA-methyltransferases (DNMT) and histone-deacetylases (HDAC), could possibly be involved in granting the virulence plasticity of Acanthamoeba spp. Methods: Four rounds of mouse passages were conducted to revive the virulence potential of the virulence-attenuated Acanthamoeba castellanii strain (ATCC 50492). Briefly, each mouse (n=6/group) was inoculated intraperitoneally with Acanthamoebae cells (2x 105 trophozoites/mouse) and incubated for 2 months. Acanthamoebae cells were isolated from infected mouse organs by culture method and subjected to subsequent mouse passage. In vitro cytopathic, encystment and gelatinolytic assays were conducted to evaluate the virulence characteristics of Acanthamoebae isolates for each passage. PCR primers which targeted on the 2 members (DNMT1 and DNMT2) and 5 members (HDAC1 to 5) of the DNMT and HDAC gene families respectively were custom designed. Quantitative real-time PCR (qPCR) was performed to detect and quantify the relative expression of the two gene families in each Acanthamoeba isolates. Beta-tubulin of A. castellanii (Genbank accession no: XP_004353728) was included as housekeeping gene for data normalisation. PCR mixtures were also analyzed by electrophoresis for amplicons detection. All statistical analyses were performed using the paired one-tailed Student’s t test. Results: Our pathogenicity tests showed that the virulence-reactivated Acanthamoeba had a higher degree of cytopathic effect on vero cells, a better resistance to encystment challenge and a higher gelatinolytic activity which was catalysed by serine protease. qPCR assay showed that DNMT1 expression was significantly higher in the virulence-reactivated compared to the virulence-attenuated Acanthamoeba strain (p ≤ 0.01). The specificity of primers which targeted on DNMT1 was confirmed by sequence analysis of PCR amplicons, which showed a 97% similarity to the published DNA-methyltransferase gene of A. castellanii (GenBank accession no: XM_004332804.1). Out of the five primer pairs which targeted on the HDAC family genes, only HDAC4 expression was significantly difference between the two variant strains. In contrast to DNMT1, HDAC4 expression was much higher in the virulence-attenuated Acanthamoeba strain. Conclusion: Our mouse passages had successfully restored the virulence of the attenuated strain. Our findings suggested that DNA-methyltransferase (DNMT1) and histone deacetylase (HDAC4) expressions are associated with virulence potential of Acanthamoeba spp.

Keywords: acanthamoeba, DNA-methyltransferase, histone deacetylase, virulence-associated proteins

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Authors: Inna Kornienko, Svetlana Guryeva, Anatoly Shekhter, Elena Petersen

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Transplantation is an effective treatment option for patients suffering from different end-stage diseases. However, it is plagued by a constant shortage of donor organs and the subsequent need of a lifelong immunosuppressive therapy for the patient. Currently some researchers look towards using of pig organs to replace human organs for transplantation since the matrix derived from porcine organs is a convenient substitute for the human matrix. As an initial step to create a new ex vivo tissue engineered model, optimized protocols have been created to obtain organ-specific acellular matrices and evaluated their potential as tissue engineered scaffolds for culture of normal cells and tumor cell lines. These protocols include decellularization by perfusion in a bioreactor system and immersion-agitation on an orbital shaker with use of various detergents (SDS, Triton X-100) and freezing. Complete decellularization – in terms of residual DNA amount – is an important predictor of probability of immune rejection of materials of natural origin. However, the signs of cellular material may still remain within the matrix even after harsh decellularization protocols. In this regard, the matrices obtained from tissues of low-immunogenic pigs with α3Galactosyl-tranferase gene knock out (GalT-KO) may be a promising alternative to native animal sources. The research included a study of induced effect of frozen and fresh fragments of GalT-KO skin on healing of full-thickness plane wounds in 80 rats. Commercially available wound dressings (Ksenoderm, Hyamatrix and Alloderm) as well as allogenic skin were used as a positive control and untreated wounds were analyzed as a negative control. The results were evaluated on the 4th day after grafting, which corresponds to the time of start of normal wound epithelization. It has been shown that a non-specific immune response in models treated with GalT-Ko pig skin was milder than in all the control groups. Research has been performed to measure technical skin characteristics: stiffness and elasticity properties, corneometry, tevametry, and cutometry. These metrics enabled the evaluation of hydratation level, corneous layer husking level, as well as skin elasticity and micro- and macro-landscape. These preliminary data may contribute to development of personalized transplantable organs from GalT-Ko pigs with significantly limited potential of immune rejection. By applying growth factors to a decellularized skin sample it is possible to achieve various regenerative effects based on the particular situation. In this particular research BMP2 and Heparin-binding EGF-like growth factor have been used. Ideally, a bioengineered organ must be biocompatible, non-immunogenic and support cell growth. Porcine organs are attractive for xenotransplantation if severe immunologic concerns can be bypassed. The results indicate that genetically modified pig tissues with knock-outed α3Galactosyl-tranferase gene may be used for production of low-immunogenic matrix suitable for transplantation.

Keywords: decellularization, low-immunogenic, matrix, scaffolds, transplants

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Authors: Atin Adhikari, Sushma Kurella, Pratik Banerjee, Nabanita Mukherjee, Yamini M. Chandana Gollapudi, Bushra Shah

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Different sharp instruments, drilling machines, and high speed rotary instruments are routinely used in dental clinics during dental cleaning. Therefore, these cleaning procedures release a lot of oral microorganisms including bacteria in clinic air and may cause significant occupational bioaerosol exposure risks for dentists, dental hygienists, patients, and dental clinic employees. Two major goals of this study were to quantify volumetric airborne concentrations of bacteria and to assess overall microbial activity in this type of occupational environment. The study was conducted in several dental clinics of southern Georgia and 15 dental cleaning procedures were targeted for sampling of airborne bacteria and testing of overall microbial activity in settled dusts over clinic floors. For air sampling, a Biostage viable cascade impactor was utilized, which comprises an inlet cone, precision-drilled 400-hole impactor stage, and a base that holds an agar plate (Tryptic soy agar). A high-flow Quick-Take-30 pump connected to this impactor pulls microorganisms in air at 28.3 L/min flow rate through the holes (jets) where they are collected on the agar surface for approx. five minutes. After sampling, agar plates containing the samples were placed in an ice chest with blue ice and plates were incubated at 30±2°C for 24 to 72 h. Colonies were counted and converted to airborne concentrations (CFU/m3) followed by positive hole corrections. Most abundant bacterial colonies (selected by visual screening) were identified by PCR amplicon sequencing of 16S rRNA genes. For understanding overall microbial activity in clinic floors and estimating a general cleanliness of the clinic surfaces during or after dental cleaning procedures, ATP levels were determined in swabbed dust samples collected from 10 cm2 floor surfaces. Concentration of ATP may indicate both the cell viability and the metabolic status of settled microorganisms in this situation. An ATP measuring kit was used, which utilized standard luciferin-luciferase fluorescence reaction and a luminometer, which quantified ATP levels as relative light units (RLU). Three air and dust samples were collected during each cleaning procedure (at the beginning, during cleaning, and immediately after the procedure was completed (n = 45). Concentrations at the beginning, during, and after dental cleaning procedures were 671±525, 917±1203, and 899±823 CFU/m3, respectively for airborne bacteria and 91±101, 243±129, and 139±77 RLU/sample, respectively for ATP levels. The concentrations of bacteria were significantly higher than typical indoor residential environments. Although an increasing trend for airborne bacteria was observed during cleaning, the data collected at three different time points were not significantly different (ANOVA: p = 0.38) probably due to high standard deviations of data. The ATP levels, however, demonstrated a significant difference (ANOVA: p <0.05) in this scenario indicating significant change in microbial activity on floor surfaces during dental cleaning. The most common bacterial genera identified were: Neisseria sp., Streptococcus sp., Chryseobacterium sp., Paenisporosarcina sp., and Vibrio sp. in terms of frequencies of occurrences, respectively. The study concluded that bacterial exposure in dental clinics could be a notable occupational biohazard, and appropriate respiratory protections for the employees are urgently needed.

Keywords: bioaerosols, hospital hygiene, indoor air quality, occupational biohazards

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Authors: Lyndsee Baumann-Birkbeck, Sohil A. Khan, Shailendra Anoopkumar-Dukie, Gary D. Grant

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Technology-enhanced education tools are being rapidly integrated into health programs globally. These tools provide an interactive platform for students and can be used to deliver topics in various modes including games and simulations. Simulations are of particular interest to healthcare education, where they are employed to enhance clinical knowledge and help to bridge the gap between theory and practice. Simulations will often assess competencies for practical tasks, yet limited research examines the effects of simulation on student perceptions of their learning. The aim of this study was to determine the effects of an interactive virtual patient simulation for pharmacology education and clinical practice on student knowledge, skills and confidence. Ethics approval for the study was obtained from Griffith University Research Ethics Committee (PHM/11/14/HREC). The simulation was intended to replicate the pharmacy environment and patient interaction. The content was designed to enhance knowledge of proton-pump inhibitor pharmacology, role in therapeutics and safe supply to patients. The tool was deployed into a third-year clinical pharmacology and therapeutics course. A number of core practice areas were examined including the competency domains of questioning, counselling, referral and product provision. Baseline measures of student self-reported knowledge, skills and confidence were taken prior to the simulation using a specifically designed questionnaire. A more extensive questionnaire was deployed following the virtual patient simulation, which also included measures of student engagement with the activity. A quiz assessing student factual and conceptual knowledge of proton-pump inhibitor pharmacology and related counselling information was also included in both questionnaires. Sixty-one students (response rate >95%) from two cohorts (2014 and 2015) participated in the study. Chi-square analyses were performed and data analysed using Fishers exact test. Results demonstrate that student knowledge, skills and confidence within the competency domains of questioning, counselling, referral and product provision, show improvement following the implementation of the virtual patient simulation. Statistically significant (p<0.05) improvement occurred in ten of the possible twelve self-reported measurement areas. Greatest magnitude of improvement occurred in the area of counselling (student confidence p<0.0001). Student confidence in all domains (questioning, counselling, referral and product provision) showed a marked increase. Student performance in the quiz also improved, demonstrating a 10% improvement overall for pharmacology knowledge and clinical practice following the simulation. Overall, 85% of students reported the simulation to be engaging and 93% of students felt the virtual patient simulation enhanced learning. The data suggests that the interactive virtual patient simulation developed for clinical pharmacology and therapeutics education enhanced students knowledge, skill and confidence, with respect to the competency domains of questioning, counselling, referral and product provision. These self-reported measures appear to translate to learning outcomes, as demonstrated by the improved student performance in the quiz assessment item. Future research of education using virtual simulation should seek to incorporate modern quantitative measures of student learning and engagement, such as eye tracking.

Keywords: clinical simulation, education, pharmacology, simulation, virtual learning

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Authors: Rijnbout-St.James Willem, Lindner Volkhard, Scholand Mary Beth, Ashton M. Tillett, Di Gennaro Michael Jude, Smith Silvia Enrica

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Introduction: Fibrosing lung diseases are characterized by changes in the lung interstitium and are classified based on etiology: 1) environmental/exposure-related, 2) autoimmune-related, 3) sarcoidosis, 4) interstitial pneumonia, and 4) idiopathic. Among interstitial lung diseases (ILD) idiopathic forms, idiopathic pulmonary fibrosis (IPF) is the most severe. Pathogenesis of IPF is characterized by an increased presence of proinflammatory mediators, resulting in alveolar injury, where injury to alveolar epithelium precipitates an increase in collagen deposition, subsequently thickening the alveolar septum and decreasing gas exchange. Identifying biomarkers implicated in the pathogenesis of lung fibrosis is key to developing new therapies and improving the efficacy of existing therapies. The transforming growth factor-beta (TGF-B1), a mediator of tissue repair associated with WNT5A signaling, is partially responsible for fibroblast proliferation in ILD and is the target of Pirfenidone, one of the antifibrotic therapies used for patients with IPF. Canonical TGF-B signaling is mediated by the proteins SMAD 2/3, which are, in turn, indirectly regulated by Collagen Triple Helix Repeat Containing 1 (CTHRC1). In this study, we tested the following hypotheses: 1) CTHRC1 is more elevated in the ILD cohort compared to unaffected controls, and 2) CTHRC1 is differently expressed among ILD types. Material and Methods: CTHRC1 levels were measured by ELISA in 171 plasma samples from the deidentified University of Utah ILD cohort. Data represent a cohort of 131 ILD-affected participants and 40 unaffected controls. CTHRC1 samples were categorized by a pulmonologist based on affectation status and disease subtypes: IPF (n = 45), sarcoidosis (4), nonspecific interstitial pneumonia (16), hypersensitivity pneumonitis (n = 7), interstitial pneumonia (n=13), autoimmune (n = 15), other ILD - a category that includes undifferentiated ILD diagnoses (n = 31), and unaffected controls (n = 40). We conducted a single-factor ANOVA of plasma CTHRC1 levels to test whether CTHRC1 variance among affected and non-affected participants is statistically significantly different. In-silico analysis was performed with Ingenuity Pathway Analysis® to characterize the role of CTHRC1 in the pathway of lung fibrosis. Results: Statistical analyses of CTHRC1 in plasma samples indicate that the average CTHRC1 level is significantly higher in ILD-affected participants than controls, with the autoimmune ILD being higher than other ILD types, thus supporting our hypotheses. In-silico analyses show that CTHRC1 indirectly activates and phosphorylates SMAD3, which in turn cross-regulates TGF-B1. CTHRC1 also may regulate the expression and transcription of TGFB-1 via WNT5A and its regulatory relationship with CTNNB1. Conclusion: In-silico pathway analyses demonstrate that CTHRC1 may be an important biomarker in ILD. Analysis of plasma samples indicates that CTHRC1 expression is positively associated with ILD affectation, with autoimmune ILD having the highest average CTHRC1 values. While characterizing CTHRC1 levels in plasma can help to differentiate among ILD types and predict response to Pirfenidone, the extent to which plasma CTHRC1 level is a function of ILD severity or chronicity is unknown.

Keywords: interstitial lung disease, CTHRC1, idiopathic pulmonary fibrosis, pathway analyses

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Authors: Lewis J. Woollin, Robert I. Davidson, Paul Watson, Philip J. Hyde

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Introduction: In-vitro testing of arthroplasty materials is of paramount importance when ensuring that they can withstand the performance requirements encountered in-vivo. One common machine used for in-vitro testing is a pin-on-plate tribometer, an early stage screening device that generates data on the wear characteristics of arthroplasty bearing materials. These devices test vertically loaded rotating cylindrical pins acting against reciprocating plates, representing the bearing surfaces. In this study, a pin-on-plate machine has been developed that provides several improvements over current technology, thereby progressing arthroplasty bearing research. Historically, pin-on-plate tribometers have been used to investigate the performance of arthroplasty bearing materials under conditions commonly encountered during a standard gait cycle; nominal operating pressures of 2-6 MPa and an operating frequency of 1 Hz are typical. There has been increased interest in using pin-on-plate machines to test more representative in-vivo conditions, due to the drive to test 'beyond compliance', as well as their testing speed and economic advantages over hip simulators. Current pin-on-plate machines do not accommodate the increased performance requirements associated with more extreme kinematic conditions, therefore a next-generation pin-on-plate tribometer has been developed to bridge the gap between current technology and future research requirements. Methodology: The design was driven by several physiologically relevant requirements. Firstly, an increased loading capacity was essential to replicate the peak pressures that occur in the natural hip joint during running and chair-rising, as well as increasing the understanding of wear rates in obese patients. Secondly, the introduction of mid-cycle load variation was of paramount importance, as this allows for an approximation of the loads present in a gait cycle to be applied and to test the fatigue properties of materials. Finally, the rig must be validated against previous-generation pin-on-plate and arthroplasty wear data. Results: The resulting machine is a twelve station device that is split into three sets of four stations, providing an increased testing capacity compared to most current pin-on-plate tribometers. The loading of the pins is generated using a pneumatic system, which can produce contact pressures of up to 201 MPa on a 3.2 mm² round pin face. This greatly exceeds currently achievable contact pressures in literature and opens new research avenues such as testing rim wear of mal-positioned hip implants. Additionally, the contact pressure of each set can be changed independently of the others, allowing multiple loading conditions to be tested simultaneously. Using pneumatics also allows the applied pressure to be switched ON/OFF mid-cycle, another feature not currently reported elsewhere, which allows for investigation into intermittent loading and material fatigue. The device is currently undergoing a series of validation tests using Ultra-High-Molecular-Weight-Polyethylene pins and 316L Stainless Steel Plates (polished to a Ra < 0.05 µm). The operating pressures will be between 2-6 MPa, operating at 1 Hz, allowing for validation of the machine against results reported previously in the literature. The successful production of this next-generation pin-on-plate tribometer will, following its validation, unlock multiple previously unavailable research avenues.

Keywords: arthroplasty, mechanical design, pin-on-plate, total joint replacement, wear testing

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Authors: Aberdam Edith, Sangari Linda, Petit Isabelle, Aberdam Daniel

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Background and Rationale: Transparent avascularised cornea is essential for normal vision and depends on limbal stem cells (LSC) that reside between the cornea and the conjunctiva. Ocular burns or injuries may destroy the limbus, causing limbal stem cell deficiency (LSCD). The cornea becomes vascularised by invaded conjunctival cells, the stroma is scarring, resulting in corneal opacity and loss of vision. Grafted autologous limbus or cultivated autologous LCS can restore the vision, unless the two eyes are affected. Alternative cellular sources have been tested in the last decades, including oral mucosa or hair follicle epithelial cells. However, only partial success has been achieved by the use of these cells since they were not able to uniformly commit into corneal epithelial cells. Human pluripotent stem cells (iPSC) display both unlimited growth capacity and ability to differentiate into any cell type. Our goal was to design a standardized and reproducible protocol to produce transplantable autologous LSC from patients through cell reprogramming technology. Methodology: First, keratinocyte primary culture was established from a small number of plucked hair follicles of healthy donors. The resulting epithelial cells were reprogrammed into induced pluripotent stem cells (iPSCs) and further differentiate into corneal epithelial cells (CEC), according to a robust protocol that recapitulates the main step of corneal embryonic development. qRT-PCR analysis and immunofluorescent staining during the course of differentiation confirm the expression of stage specific markers of corneal embryonic lineage. First appear ectodermal progenitor-specific cytokeratins K8/K18, followed at day 7 by limbal-specific PAX6, TP63 and cytokeratins K5/K14. At day 15, K3/K12+-corneal cells are present. To amplify the iPSC-derived LSC (named COiPSC), intact small epithelial colonies were detached and cultivated in limbal cell-specific medium. In that culture conditions, the COiPSC can be frozen and thaw at any passage, while retaining their corneal characteristics for at least eight passages. To evaluate the potential of COiPSC as an alternative ocular toxicity model, COiPSC were treated at passage P0 to P4 with increasing amounts of SDS and Benzalkonium. Cell proliferation and apoptosis of treated cells was compared to LSC and the SV40-immortalized human corneal epithelial cell line (HCE) routinely used by cosmetological industrials. Of note, HCE are more resistant to toxicity than LSC. At P0, COiPSC were systematically more resistant to chemical toxicity than LSC and even to HCE. Remarkably, this behavior changed with passage since COiPSC at P2 became identical to LSC and thus closer to physiology than HCE. Comparative transcriptome analysis confirmed that COiPSC from P2 are similar to a mixture of LSC and CEC. Finally, by organotypic reconstitution assay, we demonstrated the ability of COiPSC to produce a 3D corneal epithelium on a stromal equivalent made of keratocytes. Conclusion: COiPSC could become valuable for two main applications: (1) an alternative robust tool to perform, in a reproducible and physiological manner, toxicity assays for cosmetic products and pharmacological tests of drugs. (2). COiPSC could become an alternative autologous source for cornea transplantation for LSCD.

Keywords: Limbal stem cell deficiency, iPSC, cornea, limbal stem cells

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Authors: Supriyo Das, Elbir Jove, Ajay Singh, Sophie Corbet, Noel Carr, Martin Deetz

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Water is a critical commodity in the healthcare and medical field. The utility of medical-grade water spans from washing surgical equipment, drug preparation to the key element of life-saving therapy such as hydrotherapy and hemodialysis for patients. A properly treated medical water reduces the bioburden load and mitigates the risk of infection, ensuring patient safety. However, any compromised condition during the production of medical-grade water can create a favorable environment for microbial growth putting patient safety at high risk. Therefore, proper upstream treatment of the medical water is essential before its application in healthcare, pharma and medical space. Reverse Osmosis (RO) is one of the most preferred treatments within healthcare industries and is recommended by all International Pharmacopeias to achieve the quality level demanded by global regulatory bodies. The RO process can remove up to 99.5% of constituents from feed water sources, eliminating bacteria, proteins and particles sizes of 100 Dalton and above. The combination of RO with other downstream water treatment technologies such as Electrodeionization and Ultrafiltration meet the quality requirements of various pharmacopeia monographs to produce highly purified water or water for injection for medical use. In the reverse osmosis process, the water from a liquid with a high concentration of dissolved solids is forced to flow through an especially engineered semi-permeable membrane to the low concentration side, resulting in high-quality grade water. However, these specially engineered RO membranes need to be sanitized either chemically or at high temperatures at regular intervals to keep the bio-burden at the minimum required level. In this paper, we talk about Dupont´s FilmTec Heat Sanitizable Reverse Osmosis membrane (HSRO) for the production of medical-grade water. An HSRO element must be pre-conditioned prior to initial use by exposure to hot water (80°C-85°C) for its stable performance and to meet the manufacturer’s specifications. Without pre-conditioning, the membrane will show variations in feed pressure operations and salt rejection. The paper will discuss the critical variables of pre-conditioning steps that can affect the overall performance of the HSRO membrane and demonstrate the data to support the need for pre-conditioning of HSRO elements. Our preliminary data suggests that there can be up to 35 % reduction in flow due to initial heat treatment, which also positively affects the increase in salt rejection. The paper will go into detail about the fundamental understanding of the performance change of HSRO after the pre-conditioning step and its effect on the quality of medical water produced. The paper will also discuss another critical point, “regular hot water sanitization” of these HSRO membranes. Regular hot water sanitization (at 80°C-85°C) is necessary to keep the membrane bioburden free; however, it can negatively impact the performance of the membrane over time. We will demonstrate several data points on hot water sanitization using FilmTec HSRO elements and challenge its robustness to produce quality medical water. The last part of this paper will discuss the construction details of the FilmTec HSRO membrane and features that make it suitable to pre-condition and sanitize at high temperatures.

Keywords: heat sanitizable reverse osmosis, HSRO, medical water, hemodialysis water, water for Injection, pre-conditioning, heat sanitization

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Authors: Harpa Ragnarsdóttir, Magnús Kjartan Gíslason, Kristín Briem, Guðný Lilja Oddsdóttir

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Introduction: Whiplash-Associated Disorder (WAD) is a health problem characterized by motor, neurological and psychosocial symptoms, stressing the need for a multimodal treatment approach. To achieve individualized multimodal approach, prognostic factors need to be identified early using validated patient-reported and objective outcome measures. The aim of this study is to demonstrate the degree of association between patient-reported and clinical outcome measures of WAD patients in the subacute phase. Methods: Individuals (n=41) with subacute (≥1, ≤3 months) WAD (I-II), medium to high-risk symptoms, or neck pain rating ≥ 4/10 on the Visual Analog Scale (VAS) were examined. Outcome measures included measurements for movement control (Butterfly test) and cervical active range of motion (cAROM) using the NeckSmart system, a computer system using an inertial measurement unit (IMU) that connects to a computer. The IMU sensor is placed on the participant’s head, who receives visual feedback about the movement of the head. Patient-reported neck disability, pain intensity, general health, self-perceived handicap, central sensitization, and difficulties due to dizziness were measured using questionnaires. Excel and R statistical software were used for statistical analyses. Results: Forty-one participants, 15 males (37%), 26 females (63%), mean (SD) age 36.8 (±12.7), underwent data collection. Mean amplitude accuracy (AA) (SD) in the Butterfly test for easy, medium, and difficult paths were 2.4mm (0.9), 4.4mm (1.8), and 6.8mm (2.7), respectively. Mean cAROM (SD) for flexion, extension, left-, and right rotation were 46.3° (18.5), 48.8° (17.8), 58.2° (14.3), and 58.9° (15.0), respectively. Mean scores on the Neck Disability Index (NDI), VAS, Dizziness Handicap Inventory (DHI), Central Sensitization Inventory (CSI), and 36-Item Short Form Survey RAND version (RAND) were 43% (17.4), 7 (1.7), 37 (25.4), 51 (17.5), and 39.2 (17.7) respectively. Females showed significantly greater deviation for AA compared to males for easy and medium Butterfly paths (p<0.05). Statistically significant moderate to strong positive correlation was found between the DHI and easy (r=0.6, p=0.05), medium (r=0.5, p=0.05)) and difficult (r=0.5, p<0.05) Butterfly paths, between the total RAND score and all cAROMs (r between 0.4-0.7, p≤0.05) except flexion (r=0.4, p=0.7), and between the NDI score and CSI (r=0.7, p<0.01), VAS (r=0.5, p<0.01), and DHI (r=0.7, p<0.01) scores respectively. Discussion: All patient-reported and objective measures were found to be outside the reference range. Results suggest females have worse movement control in the neck in the subacute WAD phase. However, no statistical difference based on gender was found in patient-reported measures. Suggesting females might have worse movement control than males in general in this phase. The correlation found between DHI and the Butterfly test can be explained because the DHI measures proprioceptive symptoms like dizziness and eye movement disorders that can affect the outcome of movement control tests. A correlation was found between the total RAND score and cAROM, suggesting that a reduced range of motion affects the quality of life. Significance: The NeckSmart system can detect abnormalities in cAROM, fine movement control, and kinesthesia of the neck. Results suggest females have worse movement control than males. Results show a moderate to a high correlation between several patient-reported and objective measurements.

Keywords: whiplash associated disorders, car-collision, neck, trauma, subacute

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Authors: Majed Al Otaibi, Melissa Lessard-Beaudoin, Amel Loudghi, Raphael Chouinard-Watkins, Melanie Plourde, Frederic Calon, C. Alexandre Castellano, Stephen Cunnane, Helene Payette, Pierrette Gaudreau, Denis Gris, Rona K. Graham

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Introduction: Alzheimer disease (AD) is a chronic disorder that affects millions of individuals worldwide. Symptoms include memory dysfunction, and also alterations in attention, planning, language and overall cognitive function. Olfactory dysfunction is a common symptom of several neurological disorders including AD. Studying the mechanisms underlying the olfactory dysfunction may therefore lead to the discovery of potential biomarkers and/or treatments for neurodegenerative diseases. Objectives: To determine if olfactory dysfunction predicts future cognitive impairment in the aging population and to characterize the olfactory system in a murine model expressing a genetic factor of AD. Method: For the human study, quantitative olfactory tests (UPSIT and OMT) have been done on 93 subjects (aged 80 to 94 years) from the Quebec Longitudinal Study on Nutrition and Successful Aging (NuAge) cohort accepting to participate in the ORCA secondary study. The telephone Modified Mini Mental State examination (t-MMSE) was used to assess cognition levels, and an olfactory self-report was also collected. In a separate cohort, olfactory cortical volume was calculated using MRI results from healthy old adults (n=25) and patients with AD (n=18) using the AAL single-subject atlas and performed with the PNEURO tool (PMOD 3.7). For the murine study, we are using Western blotting, RT-PCR and immunohistochemistry. Result: Human Study: Based on the self-report, 81% of the participants claimed to not suffer from any problem with olfaction. However, based on the UPSIT, 94% of those subjects showed a poor olfactory performance and different forms of microsmia. Moreover, the results confirm that olfactory function declines with age. We also detected a significant decrease in olfactory cortical volume in AD individuals compared to controls. Murine study: Preliminary data demonstrate there is a significant decrease in expression levels of the proform of caspase-3 and the caspase substrate STK3, in the olfactory bulb of mice expressing human APOE4 compared with controls. In addition, there is a significant decrease in the expression level of the caspase-9 proform and caspase-8 active fragment. Analysis of the mature neuron marker, NeuN, shows decreased expression levels of both isoforms. The data also suggest that Iba-1 immunostaining is increased in the olfactory bulb of APOE4 mice compared to wild type mice. Conclusions: The activation of caspase-3 may be the cause of the decreased levels of STK3 through caspase cleavage and may play role in the inflammation observed. In the clinical study, our results suggest that seniors are unaware of their olfactory function status and therefore it is not sufficient to measure olfaction using the self-report in the elderly. Studying olfactory function and cognitive performance in the aging population will help to discover biomarkers in the early stage of the AD.

Keywords: Alzheimer's disease, APOE4, cognition, caspase, brain atrophy, neurodegenerative, olfactory dysfunction

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Authors: A. Newman-Tancredi, R. Depoortère, P. Gruca, E. Litwa, M. Lason, M. Papp

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The N-methyl-D-aspartic acid (NMDA) receptor antagonist, ketamine, can elicit rapid-acting antidepressant (RAAD) effects in treatment-resistant patients, but it requires parenteral co-administration with a classical antidepressant under medical supervision. In addition, ketamine can also produce serious side effects that limit its long-term use, and there is much interest in identifying RAADs based on ketamine’s mechanism of action but with safer profiles. Ketamine elicits GABAergic interneuron inhibition, glutamatergic neuron stimulation, and, notably, activation of serotonin 5-HT1A receptors in the prefrontal cortex (PFC). Direct activation of the latter receptor subpopulation with selective ‘biased agonists’ may therefore be a promising strategy to identify novel RAADs and, consistent with this hypothesis, the prototypical cortical biased agonist, NLX-101, exhibited robust RAAD-like activity in the chronic mild stress model of depression (CMS). The present study compared the effects of a novel, selective 5-HT1A receptor-biased agonist, NLX-204, with those of ketamine and NLX-101. Materials and methods: CMS procedure was conducted on Wistar rats; drugs were administered either intraperitoneally (i.p.) or by bilateral intracortical microinjection. Ketamine: 10 mg/kg i.p. or 10 µg/side in PFC; NLX-204 and NLX-101: 0.08 and 0.16 mg/kg i.p. or 16 µg/side in PFC. In addition, interaction studies were carried out with systemic NLX-204 or NLX-101 (each at 0.16 mg/kg i.p.) in combination with intracortical WAY-100635 (selective 5-HT1A receptor antagonist; 2 µg/side) or muscimol (GABA-A receptor agonist, 12.5 ng/side). Anhedonia was assessed by CMS-induced decrease in sucrose solution consumption; anxiety-like behavior was assessed using the Elevated Plus Maze (EPM), and cognitive impairment was assessed by the Novel Object Recognition (NOR) test. Results: A single administration of NLX-204 was sufficient to reverse the CMS-induced deficit in sucrose consumption, similarly to ketamine and NLX-101. NLX-204 also reduced CMS-induced anxiety in the EPM and abolished CMS-induced NOR deficits. These effects were maintained (EPM and NOR) or enhanced (sucrose consumption) over a subsequent 2-week period of treatment. The anti-anhedonic response of the drugs was also maintained for several weeks Following treatment discontinuation, suggesting that they had sustained effects on neuronal networks. A single PFC administration of NLX-204 reversed deficient sucrose consumption, similarly to ketamine and NLX-101. Moreover, the anti-anhedonic activities of systemic NLX-204 and NLX 101 were abolished by coadministration with intracortical WAY-100635 or muscimol. Conclusions: (i) The antidepressant-like activity of NLX-204 in the rat CMS model was as rapid as that of ketamine or NLX-101, supporting targeting cortical 5-HT1A receptors with selective, biased agonists to achieve RAAD effects. (ii)The anti-anhedonic activity of systemic NLX-204 was mimicked by local administration of the compound in the PFC, confirming the involvement of cortical circuits in its RAAD-like effects. (iii) Notably, the effects of systemic NLX-204 and NLX-101 were abolished by PFC administration of muscimol, indicating that they act by (indirectly) eliciting a reduction in cortical GABAergic neurotransmission. This is consistent with ketamine’s mechanism of action and suggests that there are converging NMDA and 5-HT1A receptor signaling cascades in PFC underlying the RAAD-like activities of ketamine and NLX-204. Acknowledgements: The study was financially supported by NCN grant no. 2019/35/B/NZ7/00787.

Keywords: depression, ketamine, serotonin, 5-HT1A receptor, chronic mild stress

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Authors: Camilo Cerda Sarabia, Fernanda Bravo Cornejo, Diego Santibanez Oyarce, Hugo Osses Prado, Esteban Gómez Terán, Belén Diaz Diaz, Raúl Caulier-Cisterna, Jorge Vergara-Quezada, Ana Moya-Beltrán

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Antimicrobial resistance (AMR) represents a significant and rapidly escalating global health threat. Projections estimate that by 2050, AMR infections could claim up to 10 million lives annually. Respiratory infections, in particular, pose a severe risk not only to individual patients but also to the broader public health system. Despite the alarming rise in resistant respiratory infections, AMR within the lung microbiome (microbial community) remains underexplored and poorly characterized. The lungs, as a complex and dynamic microbial environment, host diverse communities of microorganisms whose interactions and resistance mechanisms are not fully understood. Unlike studies that focus on individual genomes, analyzing the entire microbiome provides a comprehensive perspective on microbial interactions, resistance gene transfer, and community dynamics, which are crucial for understanding AMR. However, this holistic approach introduces significant computational challenges and exposes the limitations of traditional analytical methods such as the difficulty of identifying the AMR. Machine learning has emerged as a powerful tool to overcome these challenges, offering the ability to analyze complex genomic data and uncover novel insights into AMR that might be overlooked by conventional approaches. This study investigates microbial resistance within the lung microbiome using unsupervised machine learning approaches to uncover resistance patterns and potential clinical associations. it downloaded and selected lung microbiome data from HumanMetagenomeDB based on metadata characteristics such as relevant clinical information, patient demographics, environmental factors, and sample collection methods. The metadata was further complemented by details on antibiotic usage, disease status, and other relevant descriptions. The sequencing data underwent stringent quality control, followed by a functional profiling focus on identifying resistance genes through specialized databases like Antibiotic Resistance Database (CARD) which contains sequences of AMR gene sequence and resistance profiles. Subsequent analyses employed unsupervised machine learning techniques to unravel the structure and diversity of resistomes in the microbial community. Some of the methods employed were clustering methods such as K-Means and Hierarchical Clustering enabled the identification of sample groups based on their resistance gene profiles. The work was implemented in python, leveraging a range of libraries such as biopython for biological sequence manipulation, NumPy for numerical operations, Scikit-learn for machine learning, Matplotlib for data visualization and Pandas for data manipulation. The findings from this study provide insights into the distribution and dynamics of antimicrobial resistance within the lung microbiome. By leveraging unsupervised machine learning, we identified novel resistance patterns and potential drivers within the microbial community.

Keywords: antibiotic resistance, microbial community, unsupervised machine learning., sequences of AMR gene

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Authors: Luciano Tarantino

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Gas gangrene is a rare, severe infection with a very high mortality rate caused by Clostridium species. The infection causes a non-suppurative localized producing gas lesion from which harmful toxins that impair the inflammatory response cause vessel damage and multiple organ failure. Gas gangrene of the liver is very rare and develops suddenly, often as a complication of abdominal surgery and liver transplantation. The present paper deals with a case of gas gangrene of the liver that occurred after percutaneous MW ablation of hepatocellular carcinoma, resulting in progressive liver necrosis and multi-organ failure in spite of specific antibiotics administration. The patient was successfully treated with percutaneous Radiofrequency ablation. Case report: Female, 76 years old, Child A class cirrhosis, treated with synchronous insertion of 3 MW antennae for large HCC (5.5 cm) in the VIII segment. 24 hours after treatment, the patient was asymptomatic and left the hospital . 2 days later, she complained of fever, weakness, abdominal swelling, and pain. Abdominal US detected a 2.3 cm in size gas-containing area, eccentric within the large (7 cm) ablated area. The patient was promptly hospitalized with the diagnosis of anaerobic liver abscess and started antibiotic therapy with Imipenem/cilastatine+metronidazole+teicoplanine. On the fourth day, the patient was moved to the ICU because of dyspnea, congestive heart failure, atrial fibrillation, right pleural effusion, ascites, and renal failure. Blood tests demonstrated severe leukopenia and neutropenia, anemia, increased creatinine and blood nitrogen, high-level FDP, and high INR. Blood cultures were negative. At US, unenhanced CT, and CEUS, a progressive enlargement of the infected liver lesion was observed. Percutaneous drainage was attempted, but only drops of non-suppurative brownish material could be obtained. Pleural and peritoneal drainages gave serosanguineous muddy fluid. The Surgeon and the Anesthesiologist excluded any indication of surgical resection because of the high perioperative mortality risk. Therefore, we asked for the informed consent of the patient and her relatives to treat the gangrenous liver lesion by percutaneous Ablation. Under conscious sedation, percutaneous RFA of GG was performed by double insertion of 3 cool-tip needles (Covidien LDT, USA ) into the infected area. The procedure was well tolerated by the patient. A dramatic improvement in the patient's condition was observed in the subsequent 24 hours and thereafter. Fever and dyspnea disappeared. Normalization of blood tests, including creatinine, was observed within 4 days. Heart performance improved, 10 days after the RFA the patient left the hospital and was followed-up with weekly as an outpatient for 2 months and every two months thereafter. At 18 months follow-up, the patient is well compensated (Child-Pugh class B7), without any peritoneal or pleural effusion and without any HCC recurrence at imaging (US every 3 months, CT every 6 months). Percutaneous RFA could be a valuable therapy of focal GG of the liver in patients non-responder to antibiotics and when surgery and liver transplantation are not feasible. A fast and early indication is needed in case of rapid worsening of patient's conditions.

Keywords: liver tumor ablation, interventional ultrasound, liver infection, gas gangrene, radiofrequency ablation

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Authors: A. Bhatt, C. Bassi, H. Farragher, J. Musk

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Background: All medicines placed on the EU market are legally required to be accompanied by labeling and package leaflet, which provide comprehensive information, enabling its safe and appropriate use. Mock-ups with results of assessments using a target patient group must be submitted for a marketing authorisation application. Consumers need confidence in non-prescription, OTC medicines in order to manage their minor ailments and umbrella brands assist purchasing decisions by assisting easy identification within a particular therapeutic area. A number of regulatory agencies have risk management tools and guidelines to assist in developing umbrella brands for OTC medicines, however assessment and decision making is subjective and inconsistent. This study presents an evaluation in the UK following the US FDA warning concerning methaemoglobinaemia following 21 reported cases (11 children under 2 years) caused by OTC oral analgesics containing benzocaine. METHODS: A standard face to face, 25 structured task based user interview testing methodology using a standard questionnaire and rating scale in consumers aged 15-91 years, was conducted independently between June and October 2015 in their homes. Whether individuals could discriminate between the labelling, safety information and warnings on cartons and PILs between 3 different OTC medicines packs with the same umbrella name was evaluated. Each pack was presented with differing information hierarchy using, different coloured cartons, containing the 3 different active ingredients, benzocaine (oromucosal spray) and two lozenges containing 2, 4, dichlorobenzyl alcohol, amylmetacresol and hexylresorcinol respectively (for the symptomatic relief of sore throat pain). The test was designed to determine whether warnings on the carton and leaflet were prominent, accessible to alert users that one product contained benzocaine, risk of methaemoglobinaemia, and refer to the leaflet for the signs of the condition and what to do should this occur. Results: Two consumers did not locate the warnings on the side of the pack, eventually found them on the back and two suggestions to further improve accessibility of the methaemoglobinaemia warning. Using a gold pack design for the oromucosal spray, all consumers could differentiate between the 3 drugs, minimum age particulars, pharmaceutical form and the risk factor methaemoglobinaemia. The warnings for benzocaine were deemed to be clear or very clear; appearance of the 3 packs were either very well differentiated or quite well differentiated. The PIL test passed on all criteria. All consumers could use the product correctly, identify risk factors ensuring the critical information necessary for the safe use was legible and easily accessible so that confusion and errors were minimised. Conclusion: Patients with known methaemoglobinaemia are likely to be vigilant in checking for benzocaine containing products, despite similar umbrella brand names across a range of active ingredients. Despite these findings, the package design and spray format were not deemed to be sufficient to mitigate potential safety risks associated with differences in target populations and contraindications when submitted to the Regulatory Agency. Although risk management tools are increasingly being used by agencies to assist in providing objective assurance of package safety, further transparency, reduction in subjectivity and proportionate risk should be demonstrated.

Keywords: labelling, OTC, risk, user testing

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Authors: Devin Doos, Ashley Hughes, Trang Pham, Paul Barach, Rami Ahmed

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Over 115,000 Health Care Workers (HCWs) have died from COVID-19, and millions have been infected while caring for patients. HCWs have filed thousands of safety complaints surrounding safety concerns due to Personal Protective Equipment (PPE) shortages, which included concerns around inadequate and PPE reuse. Protocols for donning and doffing PPE remain ambiguous, lacking an evidence-base, and often result in wide deviations in practice. PPE donning and doffing protocol deviations commonly result in self-contamination but have not been thoroughly addressed. No evidence-driven protocols provide guidance on protecting HCW during periods of PPE reuse. Objective: The aim of this study was to examine safety-related threats and risks to Health Care Workers (HCWs) due to the reuse of PPE among Emergency Department personnel. Method: We conducted a prospective observational study to examine the risks of reusing PPE. First, ED personnel were asked to don and doff PPE in a simulation lab. Each participant was asked to don and doff PPE five times, according to the maximum reuse recommendation set by the Centers for Disease Control and Prevention (CDC). Each participant was videorecorded; video recordings were reviewed and coded independently by at least 2 of the 3trained coders for safety behaviors and riskiness of actions. A third coder was brought in when the agreement between the 2 coders could not be reached. Agreement between coders was high (81.9%), and all disagreements (100%) were resolved via consensus. A bowtie risk assessment chart was constructed analyzing the factors that contribute to increased risks HCW are faced with due to PPE use and reuse. Agreement amongst content experts in the field of Emergency Medicine, Human Factors, and Anesthesiology was used to select aspects of health care that both contribute and mitigate risks associated with PPE reuse. Findings: Twenty-eight clinician participants completed five rounds of donning/doffing PPE, yielding 140 PPE donning/doffing sequences. Two emerging threats were associated with behaviors in donning, doffing, and re-using PPE: (i) direct exposure to contaminant, and (ii) transmission/spread of contaminant. Protective behaviors included: hand hygiene, not touching the patient-facing surface of PPE, and ensuring a proper fit and closure of all PPE materials. 100% of participants (n= 28) deviated from the CDC recommended order, and most participants (92.85%, n=26) self-contaminated at least once during reuse. Other frequent errors included failure to tie all ties on the PPE (92.85%, n=26) and failure to wash hands after a contamination event occurred (39.28%, n=11). Conclusions: There is wide variation and regular errors in how HCW don and doffPPE while including in reusing PPE that led to self-contamination. Some errors were deemed “recoverable”, such as hand washing after touching a patient-facing surface to remove the contaminant. Other errors, such as using a contaminated mask and accidentally spreading to the neck and face, can lead to compound risks that are unique to repeated PPE use. A more comprehensive understanding of the contributing threats to HCW safety and complete approach to mitigating underlying risks, including visualizing with risk management toolsmay, aid future PPE designand workflow and space solutions.

Keywords: bowtie analysis, health care, PPE reuse, risk management

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Authors: Adriana Haulica

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Powered by Machine Learning, Precise medicine is tailored by now to use genetic and molecular profiling, with the aim of optimizing the therapeutic benefits for cohorts of patients. As the majority of Machine Language algorithms come from heuristics, the outputs have contextual validity. This is not very restrictive in the sense that medicine itself is not an exact science. Meanwhile, the progress made in Molecular Biology, Bioinformatics, Computational Biology, and Precise Medicine, correlated with the huge amount of human biology data and the increase in computational power, opens new healthcare challenges. A more accurate diagnosis is needed along with real-time treatments by processing as much as possible from the available information. The purpose of this paper is to present a deeper vision for the future of Artificial Intelligence in Precise medicine. In fact, actual Machine Learning algorithms use standard mathematical knowledge, mostly Euclidian metrics and standard computation rules. The loss of information arising from the classical methods prevents obtaining 100% evidence on the diagnosis process. To overcome these problems, we introduce MEDICOMPILLS, a new architectural concept tool of information processing in Precise medicine that delivers diagnosis and therapy advice. This tool processes poly-field digital resources: global knowledge related to biomedicine in a direct or indirect manner but also technical databases, Natural Language Processing algorithms, and strong class optimization functions. As the name suggests, the heart of this tool is a compiler. The approach is completely new, tailored for omics and clinical data. Firstly, the intrinsic biological intuition is different from the well-known “a needle in a haystack” approach usually used when Machine Learning algorithms have to process differential genomic or molecular data to find biomarkers. Also, even if the input is seized from various types of data, the working engine inside the MEDICOMPILLS does not search for patterns as an integrative tool. This approach deciphers the biological meaning of input data up to the metabolic and physiologic mechanisms, based on a compiler with grammars issued from bio-algebra-inspired mathematics. It translates input data into bio-semantic units with the help of contextual information iteratively until Bio-Logical operations can be performed on the base of the “common denominator “rule. The rigorousness of MEDICOMPILLS comes from the structure of the contextual information on functions, built to be analogous to mathematical “proofs”. The major impact of this architecture is expressed by the high accuracy of the diagnosis. Detected as a multiple conditions diagnostic, constituted by some main diseases along with unhealthy biological states, this format is highly suitable for therapy proposal and disease prevention. The use of MEDICOMPILLS architecture is highly beneficial for the healthcare industry. The expectation is to generate a strategic trend in Precise medicine, making medicine more like an exact science and reducing the considerable risk of errors in diagnostics and therapies. The tool can be used by pharmaceutical laboratories for the discovery of new cures. It will also contribute to better design of clinical trials and speed them up.

Keywords: bio-semantic units, multiple conditions diagnosis, NLP, omics

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Authors: Adam J. Bowen

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Abstract— Should robots have rights or legal protections. Often debates concerning whether robots and AI should be afforded rights focus on conditions of personhood and the possibility of future advanced forms of AI satisfying particular intrinsic cognitive and moral attributes of rights-holding persons. Such discussions raise compelling questions about machine consciousness, autonomy, and value alignment with human interests. Although these are important theoretical concerns, especially from a future design perspective, they provide limited guidance for addressing the moral and legal standing of current and near-term AI that operate well below the cognitive and moral agency of human persons. Robots and AI are already being pressed into service in a wide range of roles, especially in healthcare and biomedical contexts. The design and large-scale implementation of robots in the context of core societal institutions like healthcare systems continues to rapidly develop. For example, we bring them into our homes, hospitals, and other care facilities to assist in care for the sick, disabled, elderly, children, or otherwise vulnerable persons. We enlist surgical robotic systems in precision tasks, albeit still human-in-the-loop technology controlled by surgeons. We also entrust them with social roles involving companionship and even assisting in intimate caregiving tasks (e.g., bathing, feeding, turning, medicine administration, monitoring, transporting). There have been advances to enable severely disabled persons to use robots to feed themselves or pilot robot avatars to work in service industries. As the applications for near-term AI increase and the roles of robots in restructuring our biomedical practices expand, we face pressing questions about the normative implications of human-robot interactions and collaborations in our collective worldmaking, as well as the moral and legal status of robots. This paper argues that robots operating in public and private spaces be afforded some protections as either moral patients or legal agents to establish prohibitions on robot abuse, misuse, and mistreatment. We already implement robots and embed them in our practices and institutions, which generates a host of human-to-machine and machine-to-machine relationships. As we interact with machines, whether in service contexts, medical assistance, or home health companions, these robots are first encountered in relationship to us and our respective roles in the encounter (e.g., surgeon, physical or occupational therapist, recipient of care, patient’s family, healthcare professional, stakeholder). This proposal aims to outline a framework for establishing limiting factors and determining the extent of moral or legal protections for robots. In doing so, it advocates for a relational approach that emphasizes the priority of mapping the complex contextually sensitive roles played and the relations in which humans and robots stand to guide policy determinations by relevant institutions and authorities. The relational approach must also be technically informed by the intended uses of the biomedical technologies in question, Design History Files, extensive risk assessments and hazard analyses, as well as use case social impact assessments.

Keywords: biomedical robots, robot ethics, robot laws, human-robot interaction

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Authors: Agata Migdalska, Joanna Berczynska, Ewa Bieniek, Jacek Sterna

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Muscle relaxation is considered important during general anesthesia for spine stabilization. In a presented case peripherally acting muscle relaxant was applied during general anesthesia for spine stabilization surgery. The patient was a dog, 11-years old, 26 kg, male, mix breed. Spine fracture was situated between Th13-L1-L2, probably due to the car accident. Preanesthetic physical examination revealed no sign underlying health issues. The dog was premedicated with midazolam 0.2 mg IM and butorphanol 2.4 mg IM. General anesthesia was induced with propofol IV. After the induction, the dog was intubated with an endotracheal tube and connected to an open-ended rebreathing system and maintained with the use of inhalation anesthesia with isoflurane in oxygen. 0,5 mg/ kg of rocuronium was given IV. Use of muscle relaxant was accompanied by an assessment of the degree of neuromuscular blockade by peripheral nerve stimulator. Electrodes were attached to the skin overlying at the peroneal nerve at the lateral cranial tibia. Four electrical pulses were applied to the nerve over a 2 second period. When satisfying nerve block was detected dog was prepared for the surgery. No further monitoring of the effectiveness of blockade was performed during surgery. Mechanical ventilation was kept during anesthesia. During surgery dog maintain stable, and no anesthesiological complication occur. Intraoperatively surgeon claimed that neuromuscular blockade results in a better approach to the spine and easier muscle manipulation which was helpful in order to see the fracture and replace bone fragments. Finally, euthanasia was performed intraoperatively as a result of vast myelomalacia process of the spinal cord. This prevented examination of the recovering process. Neuromuscular blocking agents act at the neuromuscular junction to provide profound muscle relaxation throughout the body. Muscle blocking agents are neither anesthetic nor analgesic; therefore inappropriately used may cause paralysis in fully conscious and feeling pain patient. They cause paralysis of all skeletal muscles, also diaphragm and intercostal muscles when given in higher doses. Intraoperative management includes maintaining stable physiological conditions, which involves adjusting hemodynamic parameters, ensuring proper ventilation, avoiding variations in temperature, maintain normal blood flow to promote proper oxygen exchange. Neuromuscular blocking agent can cause many side effects like residual paralysis, anaphylactic or anaphylactoid reactions, delayed recovery from anesthesia, histamine release, recurarization. Therefore reverse drug like neostigmine (with glikopyrolat) or edrofonium (with atropine) should be used in case of a life-threatening situation. Another useful drug is sugammadex, although the cost of this drug strongly limits its use. Muscle relaxant improves surgical conditions during spinal surgery, especially in heavily muscled individuals. They are also used to facilitate the replacement of dislocated joints as they improve conditions during fracture reduction. It is important to emphasize that in a patient with muscle weakness neuromuscular blocking agents may result in intraoperative and early postoperative cardiovascular and respiratory complications, as well as prolonged recovery from anesthesia. This should not appear in patients with recent spine fracture or luxation. Therefore it is believed that neuromuscular blockers could be useful during spine stabilization procedures.

Keywords: anesthesia, dog, neuromuscular block, spine surgery

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Authors: Islam Sherif, Ahmed Ashour, Ahmed Hassan, Hatem Osman

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Anterior Cruciate Ligament (ACL) injuries are common among athletes and individuals participating in sports with sudden stops, pivots, and changes in direction. Arthroscopic surgery is the gold standard for ACL reconstruction, aiming to restore knee stability and function. Recent years have witnessed significant advancements in arthroscopic surgery techniques, graft materials, and technological innovations, revolutionizing the field of ACL reconstruction. This presentation delves into the latest advancements in arthroscopic surgery techniques for ACL reconstruction and their potential impact on patient outcomes. Traditionally, autografts from the patellar tendon, hamstring tendon, or quadriceps tendon have been commonly used for ACL reconstruction. However, recent studies have explored the use of allografts, synthetic scaffolds, and tissue-engineered grafts as viable alternatives. This abstract evaluates the benefits and potential drawbacks of each graft type, considering factors such as graft incorporation, strength, and risk of graft failure. Moreover, the application of augmented reality (AR) and virtual reality (VR) technologies in surgical planning and intraoperative navigation has gained traction. AR and VR platforms provide surgeons with detailed 3D anatomical reconstructions of the knee joint, enhancing preoperative visualization and aiding in graft tunnel placement during surgery. We discuss the integration of AR and VR in arthroscopic ACL reconstruction procedures, evaluating their accuracy, cost-effectiveness, and overall impact on surgical outcomes. Beyond graft selection and surgical navigation, patient-specific planning has gained attention in recent research. Advanced imaging techniques, such as MRI-based personalized planning, enable surgeons to tailor ACL reconstruction procedures to each patient's unique anatomy. By accounting for individual variations in the femoral and tibial insertion sites, this personalized approach aims to optimize graft placement and potentially improve postoperative knee kinematics and stability. Furthermore, rehabilitation and postoperative care play a crucial role in the success of ACL reconstruction. This abstract explores novel rehabilitation protocols, emphasizing early mobilization, neuromuscular training, and accelerated recovery strategies. Integrating technology, such as wearable sensors and mobile applications, into postoperative care can facilitate remote monitoring and timely intervention, contributing to enhanced rehabilitation outcomes. In conclusion, this presentation provides an overview of the cutting-edge advancements in arthroscopic surgery techniques for ACL reconstruction. By embracing innovative graft materials, augmented reality, patient-specific planning, and technology-driven rehabilitation, orthopedic surgeons and sports medicine specialists can achieve superior outcomes in ACL injury management. These developments hold great promise for improving the functional outcomes and long-term success rates of ACL reconstruction, benefitting athletes and patients alike.

Keywords: arthroscopic surgery, ACL, autograft, allograft, graft materials, ACL reconstruction, synthetic scaffolds, tissue-engineered graft, virtual reality, augmented reality, surgical planning, intra-operative navigation

Procedia PDF Downloads 91