Search results for: month of pregnancy

Authors: Jiri Nepereny, Vladimir Vrzal

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Staphylococcus intermedius/pseudintermedius bacteria are commonly found on the skin of healthy dogs and can cause pruritic skin diseases under certain circumstances (trauma, allergy, immunodeficiency, ectoparasitosis, endocrinological diseases, glucocorticoid therapy, etc.). These can develop into complicated superficial or deep pyoderma, which represent a large group of problematic skin diseases in dogs. These are predominantly inflammations of a secondary nature, associated with the occurrence of coagulase-positive Staphylococcus spp. A major problem is increased itching, which greatly complicates the healing process. The aim of this work is to verify the efficacy of the developed preparation Bacteriophage SI (Staphylococcus intermedius). The tested preparation contains a lysate of bacterial cells of S. intermedius host culture including culture medium and live virions of specific phage. Sodium Merthiolate is added as a preservative in a safe concentration. Validation of the efficacy of the product was demonstrated by monitoring the therapeutic effect after application to indicated cases from clinical practice. The indication for inclusion of the patient into the trial was an adequate history and clinical examination accompanied by sample collection for bacteriological examination and isolation of the specific causative agent. Isolate identification was performed by API BioMérieux identification system (API ID 32 STAPH) and rep-PCR typing. The suitability of therapy for a specific case was confirmed by in vitro testing of the lytic ability of the bacteriophage to lyse the specific isolate = formation of specific plaques on the culture isolate on the surface of the solid culture medium. So far, a total of 32 dogs of different sexes, ages and breed affiliations with different symptoms of staphylococcal dermatitis have been included in the testing. Their previous therapy consisted of more or less successful systemic or local application of broad-spectrum antibiotics. The presence of S. intermedius/pseudintermedius has been demonstrated in 26 cases. The isolates were identified as a S. pseudintermedius, in all cases. Contaminant bacterial microflora was always present in the examined samples. The test product was applied subcutaneously in gradually increasing doses over a period of 1 month. After improvement in health status, maintenance therapy was followed by application of the product once a week for 3 months. Adverse effects associated with the administration of the product (swelling at the site of application) occurred in only 2 cases. In all cases, there was a significant reduction in clinical signs (healing of skin lesions and reduction of inflammation) after therapy and an improvement in the well-being of the treated animals. A major problem in the treatment of pyoderma is the frequent resistance of the causative agents to antibiotics, especially the increasing frequency of multidrug-resistant and methicillin-resistant S. pseudintermedius (MRSP) strains. Specific phagolysate using for the therapy of these diseases could solve this problem and to some extent replace or reduce the use of antibiotics, whose frequent and widespread application often leads to the emergence of resistance. The advantage of the therapeutic use of bacteriophages is their bactericidal effect, high specificity and safety. This work was supported by Project FV40213 from Ministry of Industry and Trade, Czech Republic.

Keywords: bacteriophage, pyoderma, staphylococcus spp, therapy

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Authors: V. Cesaroni, C. Girometta, A. Bernicchia, M. Brusoni, F. Corana, R. M. Baiguera, C. M. Cusaro, M. L. Guglielminetti, B. Mannucci, H. Kawagishi, C. Perini, A. M. Picco, P. Rossi, E. Salerni, E. Savino

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Fungi of the genus Hericium contain various compounds with antibacterial activity, cytotoxic effect on cancer cells and bioactive molecules. Some of the active metabolites stimulate the synthesis of the Nerve Growth Factor (NGF). Recently, the effect of dietary supplement based on Hericium erinaceus on recognition memory and on hippocampal mossy fiber-CA3 neurotransmission was published. The aim of this study was to investigate the presence of Hericium species on Italian territory in order to isolate the strains for further studies and applications. The first step was to collect Hericium sporophores in Tuscany: H. alpestre Pers., H. coralloides (Scop.) Pers. and H. erinaceus (Bull.) Pers. were the species present. The strains of H. alpestre (H.a.1), H. coralloides (H.c.1) and H. erinaceus (H.e.1 & H.e.2) have been isolated in pure culture and preserved in the collection of the University of Pavia (MicUNIPV). The DNA sequences obtained from the strains were compared to other sequences found in international databases. Therefore, it was possible to construct a phylogenetic tree that highlights the clear separation in clades of the sequences and the molecular identification of our strains with the species of Hericium considered. The second step was to cultivate indoor and outdoor H. erinaceus in order to obtain as many sporophores as possible for further chemical analysis. All the procedures for H. erinaceus cultivation have been followed. Among the available recipes for indoor H. erinaceus cultivation, it was used a substrate formulation contained 70% oak sawdust, 20% rice bran, 10% wheat straw, 1% CaCO3 and 1% sucrose. The bioactive compounds present in the mycelia and in the sporophores of H. erinaceus were chemically analyzed in collaboration with the Centro Grandi Strumenti of the University of Pavia using high-performance liquid chromatography/electrospray ionization tandem mass spectrometry (HPLC/ESI-MS/MS). The materials to be analyzed were previously freeze-dried and then extracted with an alcoholic procedure. Preliminary chromatographic analysis revealed the presence of potentially bioactive and structurally different secondary metabolites such as polysaccharides, erinacins, ericenones, steroids and other terpenoids. Ericenones C and D (in sporophores) and erinacin A (in mycelium) have been identified by comparison with the respective standards. These molecules are known to have effects on the Central Nervous System (CNS) cells, which is the main objective of our studies. Thanks to the high sensitivity in the detection of bioactive compounds of H. erinaceus, it will be possible to use the To obtain lyophilized mycelium and the respective culture broth, 4 small pieces (about 5 mm2) of the respective H.e.1 or H.c.1 strains, taken from the margin of growing cultures (MEA), were inoculated into 1 liter of 2% ME (malt extract, Biokar Diagnostics). The static liquid cultures were kept at 24 °C in the dark chamber and fungi grew for one month. 10 replicates for each strain have been done. The method proposed as an analytical screening protocol to determine the optimal growth conditions of the fungus and to improve the production chain of H. erinaceus. These results encourage to carry out chemical analyzes also on H. alpestre and H. coralloides in order to evaluate the presence of bioactive compounds in these two species.

Keywords: Hericium species, Hercium erinaceus bioactive compounds, medicinal mushrooms, mushroom cultivation

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Authors: Terryann Clark, Kabir Dasgupta, Sonia Lewycka, Gail Pacheco, Alexander Plum

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This paper focused on two main research aims using data from the Growing Up in New Zealand (GUINZ) birth cohort: 1. To examine ethnic differences in life-course trajectories in the use and experience of healthcare services in early childhood years (namely immunisation, dental checks and use of General Practitioners (GPs)) 2. To quantify the contribution of relevant explanatory factors to ethnic differences. Current policy in New Zealand indicates there should be, in terms of associated direct costs, equitable access by ethnicity for healthcare services. However, empirical evidence points to persistent ethnic gaps in several domains. For example, the data highlighted that Māori have the lowest immunisation rates, across a number of time points in early childhood – despite having a higher antenatal intention to immunise relative to NZ European. Further to that, NZ European are much more likely to have their first-choice lead maternity caregiver (LMC) and use child dental services compared to all ethnicities. Method: This research explored the underlying mechanisms behind ethnic differences in the use and experience of child healthcare services. First, a multivariate regression analysis was used to adjust raw ethnic gaps in child health care utilisation by relevant covariates. This included a range of factors, encompassing mobility, socio-economic status, mother and child characteristics, household characteristics and other social aspects. Second, a decomposition analysis was used to assess the proportion of each ethnic gap that can be explained, as well as the main drivers behind the explained component. The analysis for both econometric approaches was repeated for each data time point available, which included antenatal, 9 months, 2 years and 4 years post-birth. Results: The following findings emerged: There is consistent evidence that Asian and Pacific peoples have a higher likelihood of child immunisation relative to NZ Europeans and Māori. This was evident at all time points except one. Pacific peoples had a lower rate relative to NZ European for receiving all first-year immunisations on time. For a number of potential individual and household predictors of healthcare service utilisation, the association is time-variant across early childhood. For example, socio-economic status appears highly relevant for timely immunisations in a child’s first year, but is then insignificant for the 15 month immunisations and those at age 4. Social factors play a key role. This included discouragement or encouragement regarding child immunisation. When broken down by source, discouragement by family has the largest marginal effect, followed by health professionals; whereas for encouragement, medical professionals have the largest positive influence. Perceived ethnically motivated discrimination by a health professional was significant with respect to both reducing the likelihood of achieving first choice LMC, and also satisfaction levels with child’s GP. Some ethnic gaps were largely unexplained, despite the wealth of factors employed as independent variables in our analysis. This included understanding why Pacific mothers are much less likely to achieve their first choice LMC compared to NZ Europeans; and also the ethnic gaps for both Māori and Pacific peoples relative to NZ Europeans concerning dental service use.

Keywords: child health, cohort analysis, ethnic disparities, primary healthcare

Procedia PDF Downloads 128

Authors: M. Trousselard, D. Steiler, C. Drogou, P. van-Beers, G. Lamour, S. N. Crosnier, O. Bouilland, P. Dubost, M. Chennaoui, D. Léger

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According to published data, undersea navigation for long periods (nuclear-powered ballistic missile submarine, SSBN) constitutes an extreme environment in which crews are subjected to multiple stresses, including the absence of natural light, illuminance below 1,000 lux, and watch schedules that do not respect natural chronobiological rhythms, for a period of 60-80 days. These stresses seem clearly detrimental to the submariners’ sleep, with consequences for their affective (seasonal affective disorder-like) and cognitive functioning. In the long term, there are abundant publications regarding the consequences of sleep disruption for the occurrence of organic cardiovascular, metabolic, immunological or malignant diseases. It seems essential to propose countermeasures for the duration of the patrol in order to reduce the negative physiological effects on the sleep and mood of submariners. Light therapy, the preferred treatment for dysfunctions of the internal biological clock and the resulting seasonal depression, cannot be used without data to assist knowledge of submariners’ chronobiology (melatonin secretion curve) during patrols, given the unusual characteristics of their working environment. These data are not available in the literature. The aim of this project was to assess, in the course of two studies, the benefits of two environmental techniques for managing chronobiological stress: techniques for optimizing potential (TOP; study 1)3, an existing programme to help in the psychophysiological regulation of stress and sleep in the armed forces, and dawn and dusk simulators (DDS, study 2). For each experiment, psychological, physiological (sleep) or biological (melatonin secretion) data were collected on D20 and D50 of patrol. In the first experiment, we studied sleep and depressive distress in 19 submariners in an operational setting on board an SSBM during a first patrol, and assessed the impact of TOP on the quality of sleep and depressive distress in these same submariners over the course of a second patrol. The submariners were trained in TOP between the two patrols for a 2-month period, at a rate of 1 h of training per week, and assigned daily informal exercises. Results show moderate disruptions in sleep pattern and duration associated with the intensity of depressive distress. The use of TOP during the following patrol improved sleep and depressive mood only in submariners who regularly practiced the techniques. In light of these limited benefits, we assessed, in a second experiment, the benefits of DDS on chronobiology (daily secretion of melatonin) and depressive distress. Ninety submariners were randomly allocated to two groups, group 1 using DDS daily, and group 2 constituting the control group. Although the placebo effect was not controlled, results showed a beneficial effect on chronobiology and depressive mood for submariners with a morning chronotype. Conclusions: These findings demonstrate the difficulty of practicing the tools of psychophysiological management in real life. They raise the question of the subjects’ autonomy with respect to using aids that involve regular practice. It seems important to study autonomy in future studies, as a cognitive resource resulting from the interaction between internal positive resources and “coping” resources, to gain a better understanding of compliance problems.

Keywords: chronobiology, light therapy, seasonal affective disorder, sleep, stress, stress management, submarine

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Authors: Gail Schofield, Antoine M. Dujon, Nicole Esteban, Rebecca M. Lester, Graeme C. Hays

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Variation in diel movement patterns during migration provides information on the strategies used by animals to maximize energy efficiency and ensure the successful completion of migration. For instance, many flying and land-based terrestrial species stop to rest and refuel at regular intervals along the migratory route, or at transitory ‘stopover’ sites, depending on resource availability. However, in cases where stopping is not possible (such as over–or through deep–open oceans, or over deserts and mountains), non-stop travel is required, with animals needing to develop strategies to rest while actively traveling. Recent advances in biologging technologies have identified mid-flight micro sleeps by swifts in Africa during the 10-month non-breeding period, and the use of lateralized sleep behavior in orca and bottlenose dolphins during migration. Here, highly accurate locations obtained by Argos-linked Fastloc-GPS transmitters of adult green (n=8 turtles, 9487 locations) and loggerhead (n=46 turtles, 47,588 locations) sea turtles migrating around thousand kilometers (over several weeks) from breeding to foraging grounds across the Indian and Mediterranean oceans were used to identify potential resting strategies. Stopovers were only documented for seven turtles, lasting up to 6 days; thus, this strategy was not commonly used, possibly due to the lack of potential ‘shallow’ ( < 100 m seabed depth) sites along routes. However, observations of the day versus night speed of travel indicated that turtles might use other mechanisms to rest. For instance, turtles traveled an average 31% slower at night compared to day during oceanic crossings. Slower travel speeds at night might be explained by turtles swimming in a less direct line at night and/or deeper dives reducing their forward motion, as indicated through studies using Argos-linked transmitters and accelerometers. Furthermore, within the first 24 h of entering waters shallower than 100 m towards the end of migration (the depth at which sea turtles can swim and rest on the seabed), some individuals travelled 72% slower at night, repeating this behavior intermittently (each time for a one-night duration at 3–6-day intervals) until reaching the foraging grounds. If the turtles were, in fact, resting on the seabed at this point, they could be inactive for up to 8-hours, facilitating protracted periods of rest after several weeks of constant swimming. Turtles might not rest every night once within these shallower depths, due to the time constraints of reaching foraging grounds and restoring depleted energetic reserves (as sea turtles are capital breeders, they tend not to feed for several months during migration to and from the breeding grounds and while breeding). In conclusion, access to data-rich, highly accurate Argos-linked Fastloc-GPS provided information about differences in the day versus night activity at different stages of migration, allowing us, for the first time, to compare the strategies used by a marine vertebrate with terrestrial land-based and flying species. However, the question of what resting strategies are used by individuals that remain in oceanic waters to forage, with combinations of highly accurate Argos-linked Fastloc-GPS transmitters and accelerometry or time-depth recorders being required for sufficient numbers of individuals.

Keywords: argos-linked fastloc GPS, data loggers, migration, resting strategy, telemetry

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Authors: Rubaiat S. Ahmed, Jemer Garrido, Sergey M. Motov

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Clinical informatics (CI) enables the transformation of data into a systematic organization that improves the quality of care and the generation of positive health outcomes.Innovative technology through informatics that compiles accurate data on analgesic utilization in the emergency department can enhance pain management in this important clinical setting. We aim to establish a simplified reporting system through CI to examine and assess the analgesic prescribing practices in the EDthrough executing a U.S. federal grant project on opioid reduction initiatives. Queried data points of interest from a level-one trauma ED’s electronic medical records were used to create data sets and develop informational/visual reporting dashboards (on Microsoft Excel and Google Sheets) concerning analgesic usage across several pre-defined parameters and performance metrics using CI. The data was then qualitatively analyzed to evaluate ED analgesic prescribing trends by departmental clinicians and leadership. During a 12-month reporting period (Dec. 1, 2020 – Nov. 30, 2021) for the ongoing project, about 41% of all ED patient visits (N = 91,747) were for pain conditions, of which 81.6% received analgesics in the ED and at discharge (D/C). Of those treated with analgesics, 24.3% received opioids compared to 75.7% receiving opioid alternatives in the ED and at D/C, including non-pharmacological modalities. Demographics showed among patients receiving analgesics, 56.7% were aged between 18-64, 51.8% were male, 51.7% were white, and 66.2% had government funded health insurance. Ninety-one percent of all opioids prescribed were in the ED, with intravenous (IV) morphine, IV fentanyl, and morphine sulfate immediate release (MSIR) tablets accounting for 88.0% of ED dispensed opioids. With 9.3% of all opioids prescribed at D/C, MSIR was dispensed 72.1% of the time. Hydrocodone, oxycodone, and tramadol usage to only 10-15% of the time, and hydromorphone at 0%. Of opioid alternatives, non-steroidal anti-inflammatory drugs were utilized 60.3% of the time, 23.5% with local anesthetics and ultrasound-guided nerve blocks, and 7.9% with acetaminophen as the primary non-opioid drug categories prescribed by ED providers. Non-pharmacological analgesia included virtual reality and other modalities. An average of 18.5 ED opioid orders and 1.9 opioid D/C prescriptions per 102.4 daily ED patient visits was observed for the period. Compared to other specialties within our institution, 2.0% of opioid D/C prescriptions are given by ED providers, compared to the national average of 4.8%. Opioid alternatives accounted for 69.7% and 30.3% usage, versus 90.7% and 9.3% for opioids in the ED and D/C, respectively.There is a pressing need for concise, relevant, and reliable clinical data on analgesic utilization for ED providers and leadership to evaluate prescribing practices and make data-driven decisions. Basic computer software can be used to create effective visual reporting dashboards with indicators that convey relevant and timely information in an easy-to-digest manner. We accurately examined our ED's analgesic prescribing practices using CI through dashboard reporting. Such reporting tools can quickly identify key performance indicators and prioritize data to enhance pain management and promote safe prescribing practices in the emergency setting.

Keywords: clinical informatics, dashboards, emergency department, health informatics, healthcare informatics, medical informatics, opioids, pain management, technology

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Authors: Pedro M. Rodrigues, Claudia Raposo, Denise Schrama, Marco Cerqueira

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Farmed fish welfare is a very recent concept, widely discussed among the scientific community. Consumers’ interest regarding farmed animal welfare standards has significantly increased in the last years posing a huge challenge to producers in order to maintain an equilibrium between good welfare principles and productivity, while simultaneously achieve public acceptance. The major bottleneck of standard aquaculture is to impair considerably fish welfare throughout the production cycle and with this, the quality of fish protein. Welfare assessment in farmed fish is undertaken through the evaluation of fish stress responses. Primary and secondary stress responses include release of cortisol and glucose and lactate to the blood stream, respectively, which are currently the most commonly used indicators of stress exposure. However, the reliability of these indicators is highly dubious, due to a high variability of fish responses to an acute stress and the adaptation of the animal to a repetitive chronic stress. Our objective is to use comparative proteomics to identify and validate a fingerprint of proteins that can present an more reliable alternative to the already established welfare indicators. In this way, the culture conditions will improve and there will be a higher perception of mechanisms and metabolic pathway involved in the produced organism’s welfare. Due to its high economical importance in Portuguese aquaculture Gilthead seabream will be the elected species for this study. Protein extracts from Gilthead Seabream fish muscle, liver and plasma, reared for a 3 month period under optimized culture conditions (control) and induced stress conditions (Handling, high densities, and Hipoxia) are collected and used to identify a putative fish welfare protein markers fingerprint using a proteomics approach. Three tanks per condition and 3 biological replicates per tank are used for each analisys. Briefly, proteins from target tissue/fluid are extracted using standard established protocols. Protein extracts are then separated using 2D-DIGE (Difference gel electrophoresis). Proteins differentially expressed between control and induced stress conditions will be identified by mass spectrometry (LC-Ms/Ms) using NCBInr (taxonomic level - Actinopterygii) databank and Mascot search engine. The statistical analysis is performed using the R software environment, having used a one-tailed Mann-Whitney U-test (p < 0.05) to assess which proteins were differentially expressed in a statistically significant way. Validation of these proteins will be done by comparison of the RT-qPCR (Quantitative reverse transcription polymerase chain reaction) expressed genes pattern with the proteomic profile. Cortisol, glucose, and lactate are also measured in order to confirm or refute the reliability of these indicators. The identified liver proteins under handling and high densities induced stress conditions are responsible and involved in several metabolic pathways like primary metabolism (i.e. glycolysis, gluconeogenesis), ammonia metabolism, cytoskeleton proteins, signalizing proteins, lipid transport. Validition of these proteins as well as identical analysis in muscle and plasma are underway. Proteomics is a promising high-throughput technique that can be successfully applied to identify putative welfare protein biomarkers in farmed fish.

Keywords: aquaculture, fish welfare, proteomics, welfare biomarkers

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Authors: Chia-Pei Chen, Yu-Ju Chen, Yu-Juei Hsu

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The prevalence and incidence of end-stage renal disease in Taiwan ranks the highest in the world. According to the statistical survey of the Ministry of Health and Welfare in 2019, kidney disease is the ninth leading cause of death in Taiwan. It leads to autonomic dysfunction, inflammatory response and symptom distress, and further increases the damage to the structure and function of the kidneys, leading to increased demand for renal replacement therapy and risks of cardiovascular disease, which also has medical costs for the society. If we can intervene in a feasible manual to effectively regulate the autonomic nerve function of CKD patients, reduce the inflammatory response and symptom distress. To prolong the progression of the disease, it will be the main goal of caring for CKD patients. This study aims to test the effect of heart rate variability biofeedback (HRVBF) on improving autonomic nerve function (Heart Rate Variability, HRV), inflammatory response (Interleukin-6 [IL-6], C reaction protein [CRP] ), symptom distress (Piper fatigue scale, Pittsburgh Sleep Quality Index [PSQI], and Beck Depression Inventory-II [BDI-II] ) in patients with chronic kidney disease. This study was experimental research, with a convenience sampling. Participants were recruited from the nephrology clinic at a medical center in northern Taiwan. With signed informed consent, participants were randomly assigned to the HRVBF or control group by using the Excel BINOMDIST function. The HRVBF group received four weekly hospital-based HRVBF training, and 8 weeks of home-based self-practice was done with StressEraser. The control group received usual care. We followed all participants for 3 months, in which we repeatedly measured their autonomic nerve function (HRV), inflammatory response (IL-6, CRP), and symptom distress (Piper fatigue scale, PSQI, and BDI-II) on their first day of study participation (baselines), 1 month, and 3 months after the intervention to test the effects of HRVBF. The results were analyzed by SPSS version 23.0 statistical software. The data of demographics, HRV, IL-6, CRP, Piper fatigue scale, PSQI, and BDI-II were analyzed by descriptive statistics. To test for differences between and within groups in all outcome variables, it was used by paired sample t-test, independent sample t-test, Wilcoxon Signed-Rank test and Mann-Whitney U test. Results: Thirty-four patients with chronic kidney disease were enrolled, but three of them were lost to follow-up. The remaining 31 patients completed the study, including 15 in the HRVBF group and 16 in the control group. The characteristics of the two groups were not significantly different. The four-week hospital-based HRVBF training combined with eight-week home-based self-practice can effectively enhance the parasympathetic nerve performance for patients with chronic kidney disease, which may against the disease-related parasympathetic nerve inhibition. In the inflammatory response, IL-6 and CRP in the HRVBF group could not achieve significant improvement when compared with the control group. Self-reported fatigue and depression significantly decreased in the HRVBF group, but they still failed to achieve a significant difference between the two groups. HRVBF has no significant effect on improving the sleep quality for CKD patients.

Keywords: heart rate variability biofeedback, autonomic nerve function, inflammatory response, symptom distress, chronic kidney disease

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Authors: Nitika Sharma, Yogesh Jain

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Introduction: An efficient Information System helps in improving the service delivery as well provides the foundation for policy and regulation of other building blocks of Health System. Health care organizations require an integrated working of its various sub-systems. An efficient EMR software boosts the teamwork amongst the various sub-systems thereby resulting in improved service delivery. Although there has been a huge impetus to EMR under the Digital India initiative, it has still not been mandated in India. It is generally implemented in huge funded public or private healthcare organizations only. Objective: The study was conducted to understand the factors that lead to the successful adoption of an affordable EMR in the low level healthcare organization. It intended to understand the design of the EMR and address the solutions to the challenges faced in adoption of the EMR. Methodology: The study was conducted in a non-profit registered Healthcare organization that has been providing healthcare facilities to more than 2500 villages including certain areas that are difficult to access. The data was collected with help of field notes, in-depth interviews and participant observation. A total of 16 participants using the EMR from different departments were enrolled via purposive sampling technique. The participants included in the study were working in the organization before the implementation of the EMR system. The study was conducted in one month period from 25 June-20 July 2018. The Ethical approval was taken from the institute along with prior approval of the participants. Data analysis: A word document of more than 4000 words was obtained after transcribing and translating the answers of respondents. It was further analyzed by focused coding, a line by line review of the transcripts, underlining words, phrases or sentences that might suggest themes to do thematic narrative analysis. Results: Based on the answers the results were thematically grouped under four headings: 1. governance of organization, 2. architecture and design of the software, 3. features of the software, 4. challenges faced in adoption and the solutions to address them. It was inferred that the successful implementation was attributed to the easy and comprehensive design of the system which has facilitated not only easy data storage and retrieval but contributes in constructing a decision support system for the staff. Portability has lead to increased acceptance by physicians. The proper division of labor, increased efficiency of staff, incorporation of auto-correction features and facilitation of task shifting has lead to increased acceptance amongst the users of various departments. Geographical inhibitions, low computer literacy and high patient load were the major challenges faced during its implementation. Despite of dual efforts made both by the architects and administrators to combat these challenges, there are still certain ongoing challenges faced by organization. Conclusion: Whenever any new technology is adopted there are certain innovators, early adopters, late adopters and laggards. The same pattern was followed in adoption of this software. He challenges were overcome with joint efforts of organization administrators and users as well. Thereby this case study provides a framework of implementing similar systems in public sector of countries that are struggling for digitizing the healthcare in presence of crunch of human and financial resources.

Keywords: EMR, healthcare technology, e-health, EHR

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Authors: Peregrine James Dalziel, Philip Vu Tran

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Objective / Introduction: Demand for radiology services from Emergency Departments (ED) continues to increase with greater demands placed on radiology staff providing reports for the management of complex cases. Queuing theory indicates that wide variability of process time with the random nature of request arrival increases the probability of significant queues. This can lead to delays in the time-to-availability of radiology reports (TTA-RR) and potentially impaired ED patient flow. In addition, greater “cognitive workload” of greater volume may lead to reduced productivity and increased errors. We sought to quantify the potential ED flow improvements obtainable from increased radiology providers serving 3 public hospitals in Melbourne Australia. We sought to assess the potential productivity gains, quality improvement and the cost-effectiveness of increased labor inputs. Methods & Materials: The Western Health Medical Imaging Department moved from single resident coverage on weekend days 8:30 am-10:30 pm to a limited period of 2 resident coverage 1 pm-6 pm on both weekend days. The TTA-RR for weekend CT scans was calculated from the PACs database for the 8 month period symmetrically around the date of staffing change. A multivariate linear regression model was developed to isolate the improvement in TTA-RR, between the two 4-months periods. Daily and hourly scan volume at the time of each CT scan was calculated to assess the impact of varying department workload. To assess any improvement in report quality/errors a random sample of 200 studies was assessed to compare the average number of clinically significant over-read addendums to reports between the 2 periods. Cost-effectiveness was assessed by comparing the marginal cost of additional staffing against a conservative estimate of the economic benefit of improved ED patient throughput using the Australian national insurance rebate for private ED attendance as a revenue proxy. Results: The primary resident on call and the type of scan accounted for most of the explained variability in time to report availability (R2=0.29). Increasing daily volume and hourly volume was associated with increased TTA-RR (1.5m (p<0.01) and 4.8m (p<0.01) respectively per additional scan ordered within each time frame. Reports were available 25.9 minutes sooner on average in the 4 months post-implementation of double coverage (p<0.01) with additional 23.6 minutes improvement when 2 residents were on-site concomitantly (p<0.01). The aggregate average improvement in TTA-RR was 24.8 hours per weekend day This represents the increased decision-making time available to ED physicians and potential improvement in ED bed utilisation. 5% of reports from the intervention period contained clinically significant addendums vs 7% in the single resident period but this was not statistically significant (p=0.7). The marginal cost was less than the anticipated economic benefit based assuming a 50% capture of improved TTA-RR inpatient disposition and using the lowest available national insurance rebate as a proxy for economic benefit. Conclusion: TTA-RR improved significantly during the period of increased staff availability, both during the specific period of increased staffing and throughout the day. Increased labor utilisation is cost-effective compared with the potential improved productivity for ED cases requiring CT imaging.

Keywords: workflow, quality, administration, CT, staffing

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Authors: Mohammad H. Yarmohammadian, Fatemeh Rezaei

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Introduction: Improving patient safety in health systems is one of the main priorities in healthcare systems, so clinical risk management in organizations has become increasingly significant. Although several tools have been developed for clinical risk management, each has its own limitations. Aims: This study aims to develop a comprehensive tool that can complete the limitations of each risk assessment and management tools with the advantage of other tools. Methods: Procedure was determined in two main stages included development of an initial model during meetings with the professors and literature review, then implementation and verification of final model. Subjects and Methods: This study is a quantitative − qualitative research. In terms of qualitative dimension, method of focus groups with inductive approach is used. To evaluate the results of the qualitative study, quantitative assessment of the two parts of the fourth phase and seven phases of the research was conducted. Purposive and stratification sampling of various responsible teams for the selected process was conducted in the operating room. Final model verified in eight phases through application of activity breakdown structure, failure mode and effects analysis (FMEA), healthcare risk priority number (RPN), root cause analysis (RCA), FT, and Eindhoven Classification model (ECM) tools. This model has been conducted typically on patients admitted in a day-clinic ward of a public hospital for surgery in October 2012 to June. Statistical Analysis Used: Qualitative data analysis was done through content analysis and quantitative analysis done through checklist and edited RPN tables. Results: After verification the final model in eight-step, patient's admission process for surgery was developed by focus discussion group (FDG) members in five main phases. Then with adopted methodology of FMEA, 85 failure modes along with its causes, effects, and preventive capabilities was set in the tables. Developed tables to calculate RPN index contain three criteria for severity, two criteria for probability, and two criteria for preventability. Tree failure modes were above determined significant risk limitation (RPN > 250). After a 3-month period, patient's misidentification incidents were the most frequent reported events. Each RPN criterion of misidentification events compared and found that various RPN number for tree misidentification reported events could be determine against predicted score in previous phase. Identified root causes through fault tree categorized with ECM. Wrong side surgery event was selected by focus discussion group to purpose improvement action. The most important causes were lack of planning for number and priority of surgical procedures. After prioritization of the suggested interventions, computerized registration system in health information system (HIS) was adopted to prepare the action plan in the final phase. Conclusion: Complexity of health care industry requires risk managers to have a multifaceted vision. Therefore, applying only one of retrospective or prospective tools for risk management does not work and each organization must provide conditions for potential application of these methods in its organization. The results of this study showed that the integrated clinical risk management model can be used in hospitals as an efficient tool in order to improve clinical governance.

Keywords: failure modes and effective analysis, risk management, root cause analysis, model

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Authors: Chandranath Chatterjee, Amina Khatun, Bhabagrahi Sahoo

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With the changing climate, precipitation events are intensified in the tropical river basins. Since these river basins are significantly influenced by the monsoonal rainfall pattern, critical impacts are observed on the agricultural practices in the downstream river reaches. This study analyses the crop damage and associated flood risk in terms of net benefit in the paddy-dominated tropical Indian delta of the Mahanadi River. The Mahanadi River basin lies in eastern part of the Indian sub-continent and is greatly affected by the southwest monsoon rainfall extending from the month of June to September. This river delta is highly flood-prone and has suffered from recurring high floods, especially after the 2000s. In this study, the lumped conceptual model, Nedbør Afstrømnings Model (NAM) from the suite of MIKE models, is used for rainfall-runoff modeling. The NAM model is laterally integrated with the MIKE11-Hydrodynamic (HD) model to route the runoffs up to the head of the delta region. To obtain the precipitation-derived future projected discharges at the head of the delta, nine Global Climate Models (GCMs), namely, BCC-CSM1.1(m), GFDL-CM3, GFDL-ESM2G, HadGEM2-AO, IPSL-CM5A-LR, IPSL-CM5A-MR, MIROC5, MIROC-ESM-CHEM and NorESM1-M, available in the Coupled Model Intercomparison Project-Phase 5 (CMIP5) archive are considered. These nine GCMs are previously found to best-capture the Indian Summer Monsoon rainfall. Based on the performance of the nine GCMs in reproducing the historical discharge pattern, three GCMs (HadGEM2-AO, IPSL-CM5A-MR and MIROC-ESM-CHEM) are selected. A higher Taylor Skill Score is considered as the GCM selection criteria. Thereafter, the 10-year return period design flood is estimated using L-moments based flood frequency analysis for the historical and three future projected periods (2010-2039, 2040-2069 and 2070-2099) under Representative Concentration Pathways (RCP) 4.5 and 8.5. A non-dimensional hydrograph analysis is performed to obtain the hydrographs for the historical/projected 10-year return period design floods. These hydrographs are forced into the calibrated and validated coupled 1D-2D hydrodynamic model, MIKE FLOOD, to simulate the flood inundation in the delta region. Historical and projected flood risk is defined based on the information about the flood inundation simulated by the MIKE FLOOD model and the inundation depth-damage-duration relationship of a normal rice variety cultivated in the river delta. In general, flood risk is expected to increase in all the future projected time periods as compared to the historical episode. Further, in comparison to the 2010s (2010-2039), an increased flood risk in the 2040s (2040-2069) is shown by all the three selected GCMs. However, the flood risk then declines in the 2070s as we move towards the end of the century (2070-2099). The methodology adopted herein for flood risk assessment is one of its kind and may be implemented in any world-river basin. The results obtained from this study can help in future flood preparedness by implementing suitable flood adaptation strategies.

Keywords: flood frequency analysis, flood risk, global climate models (GCMs), paddy cultivation

Procedia PDF Downloads 41

Authors: Prem K. Mony, Bharadwaj Amrutur, Prashanth Thankachan, Swarnarekha Bhat, Suman Rao, Maryann Washington, Annamma Thomas, N. Sheela, Hiteshwar Rao, Sumi Antony

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The disease burden among mothers and newborns is caused mostly by a handful of avoidable conditions occurring around the time of childbirth and within the first month following delivery. Real-time monitoring of vital parameters of mothers and neonates offers a potential opportunity to impact access as well as the quality of care in vulnerable populations. We describe the design, development and testing of an innovative wearable device for remote biomonitoring (RBM) of body temperatures in mothers and neonates in a hospital in southern India. The architecture consists of: [1] a low-cost, wearable sensor tag; [2] a gateway device for ‘real-time’ communication link; [3] piggy-backing on a commercial GSM communication network; and [4] an algorithm-based data analytics system. Requirements for the device were: long battery-life upto 28 days (with sampling frequency 5/hr); robustness; IP 68 hermetic sealing; and human-centric design. We undertook pre-clinical laboratory testing followed by clinical trial phases I & IIa for evaluation of safety and efficacy in the following sequence: seven healthy adult volunteers; 18 healthy mothers; and three sets of babies – 3 healthy babies; 10 stable babies in the Neonatal Intensive Care Unit (NICU) and 1 baby with hypoxic ischaemic encephalopathy (HIE). The 3-coin thickness, pebble-design sensor weighing about 8 gms was secured onto the abdomen for the baby and over the upper arm for adults. In the laboratory setting, the response-time of the sensor device to attain thermal equilibrium with the surroundings was 4 minutes vis-a-vis 3 minutes observed with a precision-grade digital thermometer used as a reference standard. The accuracy was ±0.1°C of the reference standard within the temperature range of 25-40°C. The adult volunteers, aged 20 to 45 years, contributed a total of 345 hours of readings over a 7-day period and the postnatal mothers provided a total of 403 paired readings. The mean skin temperatures measured in the adults by the sensor were about 2°C lower than the axillary temperature readings (sensor =34.1 vs digital = 36.1); this difference was statistically significant (t-test=13.8; p<0.001). The healthy neonates provided a total of 39 paired readings; the mean difference in temperature was 0.13°C (sensor =36.9 vs digital = 36.7; p=0.2). The neonates in the NICU provided a total of 130 paired readings. Their mean skin temperature measured by the sensor was 0.6°C lower than that measured by the radiant warmer probe (sensor =35.9 vs warmer probe = 36.5; p < 0.001). The neonate with HIE provided a total of 25 paired readings with the mean sensor reading being not different from the radian warmer probe reading (sensor =33.5 vs warmer probe = 33.5; p=0.8). No major adverse events were noted in both the adults and neonates; four adult volunteers reported mild sweating under the device/arm band and one volunteer developed mild skin allergy. This proof-of-concept study shows that real-time monitoring of temperatures is technically feasible and that this innovation appears to be promising in terms of both safety and accuracy (with appropriate calibration) for improved maternal and neonatal health.

Keywords: public health, remote biomonitoring, temperature surveillance, wearable sensors, mothers and newborns

Procedia PDF Downloads 181

Authors: Aleksandra Chałupnik, Zuzanna Chilimoniuk, Joanna Borowik, Aleksandra Borkowska, Anna Torres

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Background: Precocious puberty is the occurrence of secondary sexual characteristics in girls before the age of 8. The diverse etiology of premature puberty is crucial to determine whether it is true precocious puberty, depending on the activation of the hypothalamic-pituitary-gonadal axis, or pseudo-precocious, which is independent of the activation of this axis. Whatever the cause, premature action of the sex hormones leads to the common symptoms of various forms of puberty. These include the development of sexual characteristics, acne, acceleration of growth rate and acceleration of skeletal maturation. Due to the possible genetic basis of the disorders, an interdisciplinary search for the cause is needed. Case report: The case report concerns a patient of a pediatric gynecology clinic who, at the age of two years, developed advanced thelarhe (M3) and started recurrent vaginal bleeding. In August 2019, gonadotropin suppression initially and after LHRH stimulation and high estradiol levels were reported at the Endocrinology Department. Imaging examinations showed a cyst in the right ovary projection. The bone age was six years. The entire clinical picture indicated pseudo- (peripheral) precocious in the course of ovarian autonomic cyst. In the follow-up ultrasound performed in September, the image of the cyst was stationary and normalization of estradiol levels and clinical symptoms was noted. In December 2019, cyst regression and normal gonadotropin and estradiol concentrations were found. In June 2020, white mucus tinged with blood on the underwear, without any other disturbing symptoms, was observed for several days. Two consecutive USG examinations carried out in the same month confirmed the change in the right ovary, the diameter of which was 25 mm with a very high level of estradiol. Germinal tumor markers were normal. On the Tanner scale, the patient scored M2P1. The labia and hymen had puberty features. The correct vaginal entrance was visible. Another active vaginal bleeding occurred in the first week of July 2020. The considered laparoscopic treatment was abandoned due to the lack of oncological indications. Treatment with Tamoxifen was recommended in July 2020. In the initiating period of treatment, no maturation progression, and even reduction of symptoms, no acceleration of growth and a marked reduction in the size of the cysts were noted. There was no bleeding. After the size of the cyst and hormonal activity increased again, the treatment was changed to Anastrozole, the effect of which led to a reduction in the size of the cyst. Conclusions: The entire clinical picture indicates alleged (peripheral) puberty. Premature puberty in girls, which is manifested as enlarged mammary glands with high levels of estrogens secreted by autonomic ovarian cysts and prepubertal levels of gonadotropins, may indicate McCune-Albright syndrome. Vaginal bleeding may also occur in this syndrome. Cancellation of surgical treatment of the cyst made it impossible to perform a molecular test that would allow to confirm the diagnosis. Taking into account the fact that cysts are often one of the first symptoms of McCune-Albrigt syndrome, it is important to remember about multidisciplinary care for the patient and careful search for skin and bone changes or other hormonal disorders.

Keywords: McCune Albrigth's syndrome, ovarian cyst, pediatric gynaecology, precocious puberty

Procedia PDF Downloads 166

Authors: Annis Lai Chu Fung

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While aggression had high stability throughout developmental stages and across generations, it should be the top priority of researchers and frontline helping professionals to develop prevention and intervention programme for aggressive children and children at risk of developing aggressive behaviours. Although there is a substantial amount of anti-bullying programmes, they gave disappointingly small effect sizes. The neglectful practical significance could be attributed to the overly simplistic categorisation of individuals involved as bullies or victims. In the past three decades, the distinction between reactive and proactive aggression has been well-proved. As children displaying reactively aggressive behaviours have distinct social-information processing pattern with those showing proactively aggressive behaviours, it is critical to identify the unique needs of the two subtypes accordingly when designing an intervention. The onset of reactive aggression and proactive aggression was observed at earliest in 4.4 and 6.8 years old respectively. Such findings called for a differential early intervention targeting these high-risk children. However, to the best of the author’s knowledge, the author was the first to establish an evidence-based intervention programme against reactive and proactive aggression. With the largest samples in the world, the author, in the past 10 years, explored three different approaches and their effectiveness against aggression quantitatively and qualitatively with longitudinal design. The three approaches presented are (a) cognitive-behavioral approach, (b) moral education, with Chinese marital arts and ethics as the medium, and (c) bioneurological measures (omega-3 supplementation). The studies adopted a multi-informant approach with repeated measures before and after the intervention, and follow-up assessment. Participants were recruited from primary and secondary schools in Hong Kong. In the cognitive-behavioral approach, 66 reactive aggressors and 63 proactive aggressors, aged from 11 to 17, were identified from 10,096 secondary-school children with questionnaire and subsequent structured interview. Participants underwent 10 group sessions specifically designed for each subtype of aggressor. Results revealed significant declines in aggression levels from the baseline to the follow-up assessment after 1 year. In moral education through the Chinese martial arts, 315 high-risk aggressive children, aged 6 to 12 years, were selected from 3,511 primary-school children and randomly assigned into four types of 10-session intervention group, namely martial-skills-only, martial-ethics-only, both martial-skills-and-ethics, and physical fitness (placebo). Results showed only the martial-skills-and-ethics group had a significant reduction in aggression after treatment and 6 months after treatment comparing with the placebo group. In the bioneurological approach, 218 children, aged from 8 to 17, were randomly assigned to the omega-3 supplement group and the placebo group. Results revealed that compared with the placebo group, the omega-3 supplement group had significant declines in aggression levels at the 6-month follow-up assessment. All three approaches were effective in reducing proactive and reactive aggression. Traditionally, intervention programmes against aggressive behaviour often adapted the cognitive and/or behavioural approach. However, cognitive-behavioural approach for children was recently challenged by its demanding requirement of cognitive ability. Traditional cognitive interventions may not be as beneficial to an older population as in young children. The present study offered an insightful perspective in aggression reduction measures.

Keywords: intervention, outcome effectiveness, proactive aggression, reactive aggression

Procedia PDF Downloads 205

Authors: Wissam Saliba, Mandy Nicholson

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Secretory carcinoma (SC) is a rare type of salivary gland cancer. It was first realized as a distinct type of malignancy in 2010and wasinitially termed “mammary analogue secretory carcinoma” because of similarities with secretory breast cancer. The name was later changed to SC. Most SCs originate in parotid glands, and most harbour a rare gene mutation: ETV6-NTRK3. This mutation is rare in common cancers and common in rare cancers; it is present in most secretory carcinomas. Disease outcomes for SC are usually described as favourable as many cases of SC are lowgrade (LG), and cancer growth is slow. In early stages, localized therapy is usually indicated (surgery and/or radiation). Despitea favourable prognosis, a sub-set of casescan be much more aggressive.These cases tend to be of high-grade(HG).HG casesare associated with a poorer prognosis.Management of such cases can be challenging due to limited evidence for effective systemic therapy options. This case report describes the clinical management of a 46-year-oldmale patient with a unique case of SC. He was initially diagnosed with a low/intermediate grade carcinoma of the left parotid gland in 2009; he was treated with surgery and adjuvant radiation. Surgical pathology favoured primary salivary adenocarcinoma, and 2 lymph nodes were positive for malignancy. SC was not yet realized as a distinct type of cancerat the time of diagnosis, and the pathology reportvalidated this gap by stating that the specimen lacked features of the defined types of salivary carcinoma.Slow-growing pulmonary nodules were identified in 2017. In 2020, approximately 11 years after the initial diagnosis, the patient presented with malignant pleural effusion. Pathology from a pleural biopsy was consistent with metastatic poorly differentiated cancer of likely parotid origin, likely mammary analogue secretory carcinoma. The specimen was sent for Next Generation Sequencing (NGS); ETV6-NTRK3 gene fusion was confirmed, and systemic therapy was initiated.One cycle ofcarboplatin/paclitaxel was given in June 2020. He was switched to Larotrectinib (NTRK inhibitor (NTRKi)) later that month. Larotrectinib continued for approximately 9 months, with discontinuation in March 2021 due to disease progression. A second-generation NTRKi (Selitrectinib) was accessed and prescribedthrough a single patient study. Selitrectinib was well tolerated. The patient experienced a complete radiological response within~4 months. Disease progression occurred once again in October 2021. Progression was slow, and Selitrectinib continuedwhile the medical team performed a thorough search for additional treatment options. In January 2022, a liver lesion biopsy was performed, and NGS showed an NTRKG623R solvent-front resistance mutation. Various treatment pathways were considered. The patient pursuedanother investigational NTRKi through a clinical trial, and Selitrectinib was discontinued in July 2022. Excellent performance status was maintained throughout the entire course of treatment.It can be concluded that NTRK inhibitors provided satisfactory treatment efficacy and tolerance for this patient with high-grade transformation and NTRK gene fusion cancer. In the future, more clinical research is needed on systemic treatment options for high-grade transformations in NTRK gene fusion SCs.

Keywords: secretory carcinoma, high-grade transformations, NTRK gene fusion, NTRK inhibitor

Procedia PDF Downloads 91

Authors: Viktorya Sargsyan, Arax Hovhannesyan, Karine Abelyan

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Introduction: During the last decade, scientific studies have proven the importance of Early Childhood Development (ECD) interventions. These interventions are shown to create strong foundations for children’s intellectual, emotional and physical well-being, as well as the impact they have on learning and economic outcomes for children as they mature into adulthood. Many children in rural Armenia fail to reach their full development potential due to lack of early brain stimulation (playing, singing, reading, etc.) from their parents, and lack of community tools and services to follow-up children’s neurocognitive development. This is exacerbated by high rates of stunting and anemia among children under 3(CU3). This research study tested the effectiveness of an integrated ECD and Maternal, Newborn and Childhood Health (MNCH) model, called “Go Baby, Go!” (GBG), against the traditional (MNCH) strategy which focuses solely on preventive health and nutrition interventions. The hypothesis of this quasi-experimental study was: Children exposed to GBG will have better neurocognitive and nutrition outcomes compared to those receiving only the MNCH intervention. The secondary objective was to assess the effect of GBG on parental child care and nutrition practices. Methodology: The 14 month long study, targeted all 1,300 children aged 0 to 23 months, living in 43 study communities the in Gavar and Vardenis regions (Gegharkunik province, Armenia). Twenty-three intervention communities, 680 children, received GBG, and 20 control communities, 630 children, received MCHN interventions only. Baseline and evaluation data on child development, nutrition status and parental child care and nutrition practices were collected (caregiver interview, direct child assessment). In the intervention sites, in addition to MNCH (maternity schools, supportive supervision for Health Care Providers (HCP), the trained GBG facilitators conducted six interactive group sessions for mothers (key messages, information, group discussions, role playing, video-watching, toys/books preparation, according to GBG curriculum), and two sessions (condensed GBG) for adult family members (husbands, grandmothers). The trained HCPs received quality supervision for ECD counseling and screening. Findings: The GBG model proved to be effective in improving ECD outcomes. Children in the intervention sites had 83% higher odd of total ECD composite score (cognitive, language, motor) compared to children in the control sites (aOR 1.83; 95 percent CI: 1.08-3.09; p=0.025). Caregivers also demonstrated better child care and nutrition practices (minimum dietary diversity in intervention site is 55 percent higher compared to control (aOR=1.55, 95 percent CI 1.10-2.19, p =0.013); support for learning and disciplining practices (aOR=2.22, 95 percent CI 1.19-4.16, p=0.012)). However, there was no evidence of stunting reduction in either study arm. he effect of the integrated model was more prominent in Vardenis, a community which is characterised by high food insecurity and limited knowledge of positive parenting skills. Conclusion: The GBG model is effective and could be applied in target areas with the greatest economic disadvantages and parenting challenges to improve ECD, care practices and developmental outcomes. Longitudinal studies are needed to view the long-term effects of GBG on learning and school readiness.

Keywords: early childhood development, integrated interventions, parental practices, quasi-experimental study

Procedia PDF Downloads 153

Authors: Chia-Jung Chen, Yu-Chi Hsu, June-Dong Lin, Kun-Chen Chan, Chieh-Tien Wang, Li-Ching Wu, Chung-Feng Liu

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With fast advances in healthcare technology, various total laboratory automation (TLA) processes have been proposed. However, adopting TLA needs quite high funding. This study explores an early adoption experience by Taiwan’s large-scale hospital group, the Chimei Hospital Group (CMG), which owns three branch hospitals (Yongkang, Liouying and Chiali, in order by service scale), based on the five stages of Everett Rogers’ Diffusion Decision Process. 1.Knowledge stage: Over the years, two weaknesses exists in laboratory department of CMG: 1) only a few examination categories (e.g., sugar testing and HbA1c) can now be completed and reported within a day during an outpatient clinical visit; 2) the Yongkang Hospital laboratory space is dispersed across three buildings, resulting in duplicated investment in analysis instruments and inconvenient artificial specimen transportation. Thus, the senior management of the department raised a crucial question, was it time to process the redesign of the laboratory department? 2.Persuasion stage: At the end of 2013, Yongkang Hospital’s new building and restructuring project created a great opportunity for the redesign of the laboratory department. However, not all laboratory colleagues had the consensus for change. Thus, the top managers arranged a series of benchmark visits to stimulate colleagues into being aware of and accepting TLA. Later, the director of the department proposed a formal report to the top management of CMG with the results of the benchmark visits, preliminary feasibility analysis, potential benefits and so on. 3.Decision stage: This TLA suggestion was well-supported by the top management of CMG and, finally, they made a decision to carry out the project with an instrument-leasing strategy. After the announcement of a request for proposal and several vendor briefings, CMG confirmed their laboratory automation architecture and finally completed the contracts. At the same time, a cross-department project team was formed and the laboratory department assigned a section leader to the National Taiwan University Hospital for one month of relevant training. 4.Implementation stage: During the implementation, the project team called for regular meetings to review the results of the operations and to offer an immediate response to the adjustment. The main project tasks included: 1) completion of the preparatory work for beginning the automation procedures; 2) ensuring information security and privacy protection; 3) formulating automated examination process protocols; 4) evaluating the performance of new instruments and the instrument connectivity; 5)ensuring good integration with hospital information systems (HIS)/laboratory information systems (LIS); and 6) ensuring continued compliance with ISO 15189 certification. 5.Confirmation stage: In short, the core process changes include: 1) cancellation of signature seals on the specimen tubes; 2) transfer of daily examination reports to a data warehouse; 3) routine pre-admission blood drawing and formal inpatient morning blood drawing can be incorporated into an automatically-prepared tube mechanism. The study summarizes below the continuous improvement orientations: (1) Flexible reference range set-up for new instruments in LIS. (2) Restructure of the specimen category. (3) Continuous review and improvements to the examination process. (4) Whether installing the tube (specimen) delivery tracks need further evaluation.

Keywords: innovation decision process, total laboratory automation, health care

Procedia PDF Downloads 398

Authors: Shyam Sunder Gupta

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For creation of Universe, theory of Big Bang , from Singularity is most acceptable theory, but has limitations as it does not answer ; how Singularity gets created and what causes Big Bang ?Further , Universe is composed of 95% Dark Energy and Dark Matter and balance 5% is visible part of Universe , but no explanation . Recently, it has been reported that there could be very large number of Universes, but only , a stipulation. This research which is based on Bhagvat Puran, a Vedic Scripture answers all questions. There is a Unique Energy Field which is eternal and infinite. The carrier Particles of Unique Energy are Paramanus; God Particles. Paramanus are Fundamental Particles and combination of these particles create bigger particles from which Universe gets created. For creation to initiate, Unique Energy gets represented in three phases; Positive Male Energy, Neutral Energy(creates Eternal Time)and Negative Female Energy. Positive Male Energy further expands in three forms of Creative Energies (CE1,CE2andCE3)and 16 principles get created, namely, Energy of Activation , Energy of Action, Energy of Darkness, Pradhan ( Equilibrium state of three energies ) , Prakriti(Non-equilibrium state of three energies, creating modes of Activation, Action and Darkness),Mahat-tattva ( consists of three modes , dominant in Mode of Darkness), Time, Energy of Consciousness, Ego Energy(consists of three modes , very strongly dominated by Mode of Darkness),Energy of Intellect, Mind Energy , Sky( creates Space and Sound Energy),Air(creates gaseous substances), Fire( creates different forms of energies like thermal, light, electrical etc.), Water( creates liquid substances)and Earth(creates solid substances). CE1 Energy creates Infinite number of Singularities from seven principles, Pradhan , Mahat-tattva, Sky , Air, Fire, Water and Earth . CE1 Energy gets divided as CE2 and enters along with other 9 principles , in each of Singularity and Primary Big Bang takes and infinite number of Universes get created. Each Universe has seven coverings of 7 principles and each layer is 10 times thicker than previous layer. By Energy CE2 , space in Universe under the coverings is divided in two parts , upper part and lower part. Upper part is occupied by Dark Energy which is created from Mode of Darkness in Ego Energy which keeps getting converted in Dark Matter and forms Invisible part of Universe. In the lower part , process of evolution gets initiated and seeds of 24 elements , Consciousness , Ego, Intellect, Mind, 5 Fundamental Elements( space, Air, Fire, Water Earth, which create non-living matter ),5 senses which receive inputs( eyes, nose, ears, tongue , skin), 5 Working Senses (Smell, Taste, Sight, Touch and Hearing);5 elements of Action( Organs of procreation , excretion, locomotion , speech and acquisition ), get created . In EC2 Energy, Singularity gets created which gets exploded by force of Energy of Action ,and Secondary Big Bang takes place and Visible Universe gets created in the shape of Bud of Flower Lotus . Within the Visible part of Universe, a small part gets created , Phenomenal Universe. Diameter of Sun and planetary system ,at the time of formation ,is 6.4 billion km, which is close to reported value . There are 5 different orbits , with reference to our Solar System. Moon around earth takes one month,, earth around sun one year, sun around Milk way one cosmic year(322.58 million years), Milky way around Universe 4.32 billion years and universe around center of universe 311.04 trillion years. Universe creation is a cyclic process with cycle time of 622.08 trillion years.In summary, Universe consists of 4 parts; covering of 7 layers, Dark Energy and Dark Matter, Visible and Phenomenal universe.

Keywords: big bang, creation, dark energy, dark matter, singularity, universe

Procedia PDF Downloads 57

Authors: Norma Kok, Diemo Masuko, Thandokazi Dlongwana, Komala Pillay

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CONTEXT: While many school principals have been outstanding teachers and have inherent leadership potential, many have not had access to the quality of leadership development or support that empowers them to produce high-quality education outcomes in extremely challenging circumstances. Further, school leaders in under-served communities face formidable challenges arising from insufficient infrastructure, overcrowded classrooms, socio-economic challenges within the community, and insufficient parental involvement, all of which put a strain on principals’ ability to lead their schools effectively. In addition few school leaders have access to other supportive networks, and many do not know how to build and leverage social capital to create opportunities for their schools and learners. Moreover, we know that fostering parental involvement in their children’s learning improves a child’s morale, attitude, and academic achievement across all subject areas, and promotes better behaviour and social adjustment. Citizen Leader Lab facilitates the Partners for Possibility (PfP) programme to provide leadership development and support to school leaders serving under-resourced communities in South Africa to create effective environments of learning. This is done by creating partnerships between school leaders and private-sector business leaders over a 12-month period. (185) OBJECTIVES: To explore school leaders’ perceptions of their leadership capacities and changes at their schools after being exposed to a year-long leadership development training programme. METHODS: School leaders gained new leadership capacities e.g. resilience, improved confidence, communication and conflict resolution skills - catalysing into improved cultures of collaborative decision-making and environments for enhanced teaching and learningprogramme based on the 70:20:10 model whereby: 10% of learning comes from workshops, 20% of learning takes place through peer learning and 70% of learning occurs through experiential learning as partnerships work together to identify and tackle challenges in targeted schools. Participants completed a post-programme questionnaire consisting of structured and unstructured questions and semi-structured interviews were conducted with them and their business leader. The interviews were audio-recorded, transcribed and thematic content analysis was undertaken. The analysis was inductive and emerging themes were identified. A code list was generated after coding was undertaken using computer software (Dedoose). Quantitative data gathered from surveys was aggregated and analysed. RESULTS: School leadership found the programme interesting and rewarding. They gained new leadership capacities such as resilience, improved confidence, communication and conflict resolution skills - catalyzing into improved cultures of collaborative decision-making and environments for enhanced teaching and learning. New networks resulted in tangible outcomes such as upgrades to school infrastructure, water and sanitation, vegetable gardens at schools resulting in nutrition for learners and/or intangible outcomes such as skills for members of school management teams (SMTs). Collaborative leadership led to SMTs being more aligned, efficient, and cohesive; and teachers being more engaged and motivated. Notable positive changes at the school inspired parents and community members to become more actively involved in the school and in their children’s education. CONCLUSION: The PfP programme leads to improved leadership capacities and improved school culture which leads to improved teaching and learning and new resources for schools.

Keywords: collaborative decision-making, collaborative leadership, community involvement, confidence

Procedia PDF Downloads 66

Authors: Vincent Schlageter, Maroua Mestiri, Florian Denzinger, Hugo Raetzo, Michel Demierre

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Precise landslide monitoring with differential global navigation satellite system (GNSS) is well known, but technical or economic reasons limit its application by geotechnical companies. This study demonstrates the reliability and the usefulness of Geomon (Infrasurvey Sàrl, Switzerland), a stand-alone and cost-effective rover network. The system permits deploying up to 15 rovers, plus one reference station for differential GNSS. A dedicated radio communication links all the modules to a base station, where an embedded computer automatically provides all the relative positions (L1 phase, open-source RTKLib software) and populates an Internet server. Each measure also contains information from an internal inclinometer, battery level, and position quality indices. Contrary to standard GNSS survey systems, which suffer from a limited number of beacons that must be placed in areas with good GSM signal, Geomon offers greater flexibility and permits a real overview of the whole landslide with good spatial resolution. Each module is powered with solar panels, ensuring autonomous long-term recordings. In this study, we have tested the system on several sites in the Swiss mountains, setting up to 7 rovers per site, for an 18 month-long survey. The aim was to assess the robustness and the accuracy of the system in different environmental conditions. In one case, we ran forced blind tests (vertical movements of a given amplitude) and compared various session parameters (duration from 10 to 90 minutes). Then the other cases were a survey of real landslides sites using fixed optimized parameters. Sub centimetric-accuracy with few outliers was obtained using the best parameters (session duration of 60 minutes, baseline 1 km or less), with the noise level on the horizontal component half that of the vertical one. The performance (percent of aborting solutions, outliers) was reduced with sessions shorter than 30 minutes. The environment also had a strong influence on the percent of aborting solutions (ambiguity search problem), due to multiple reflections or satellites obstructed by trees and mountains. The length of the baseline (distance reference-rover, single baseline processing) reduced the accuracy above 1 km but had no significant effect below this limit. In critical weather conditions, the system’s robustness was limited: snow, avalanche, and frost-covered some rovers, including the antenna and vertically oriented solar panels, leading to data interruption; and strong wind damaged a reference station. The possibility of changing the sessions’ parameters remotely was very useful. In conclusion, the rover network tested provided the foreseen sub-centimetric-accuracy while providing a dense spatial resolution landslide survey. The ease of implementation and the fully automatic long-term survey were timesaving. Performance strongly depends on surrounding conditions, but short pre-measures should allow moving a rover to a better final placement. The system offers a promising hazard mitigation technique. Improvements could include data post-processing for alerts and automatic modification of the duration and numbers of sessions based on battery level and rover displacement velocity.

Keywords: GNSS, GSM, landslide, long-term, network, solar, spatial resolution, sub-centimeter.

Procedia PDF Downloads 93

Authors: A. Aceranti, L. Moretti, S. Vernocchi, M. Colorato, P. Caristia

Abstract:

Irritable bowel syndrome (IBS) is the association between abdominal pain, abdominal distension and intestinal dysfunction for recurring periods. About 10% of the world's population has IBS at any given time in their life, and about 200 people per 100,000 receive an initial diagnosis of IBS each year. Persistent pain is recognized as one of the most pervasive and challenging problems facing the medical community today. Persistent pain is considered more as a complex pathophysiological, diagnostic and therapeutic situation rather than as a persistent symptom. The low efficiency of conventional drug treatments has led many doctors to become interested in the non-drug alternative treatment of IBS, especially for more severe cases. Patients and providers are often dissatisfied with the available drug remedies and often seek complementary and alternative medicine (CAM), a unique and holistic approach to treatment that is not a typical component of conventional medicine. Osteopathic treatment may be of specific interest in patients with IBS. Osteopathy is a complementary health approach that emphasizes the role of the musculoskeletal system in health and promotes optimal function of the body's tissues using a variety of manual techniques to improve body function. Osteopathy has been defined as a patient-centered health discipline based on the principles of interrelation between body structure and function, the body's innate capacity for self-healing and the adoption of a whole person health approach. mainly by practicing manual processing. Studies reported that osteopathic manual treatment (OMT) reduced IBS symptoms, such as abdominal pain, constipation, diarrhea, and improved general well-being. The focus in the treatment of IBS with osteopathy has gone beyond simple spinal alignment, to directly address the abnormal physiology of the body using a series of direct and indirect techniques. The topic of this study was chosen for different reasons: due to the large number of people involved who suffer from this disorder and for the dysfunction itself, since nowadays there is still little clarity about the best type of treatment and, above all, to its origin. The visceral component in the osteopathic field is still a world to be discovered, although it is related to a large part of patient series, it has contents that affect numerous disciplines and this makes it an enigma yet to be solved. The study originated in the didactic practice where the curiosity of a topic is marked that, even today, no one is able to explain and, above all, cure definitively. The main purpose of this study is to try to create a good basis on the osteopathic discipline for subsequent studies that can be exhaustive in the best possible way, resolving some doubts about which treatment modality can be used with more relevance. The path was decided to structure it in such a way that 3 types of osteopathic treatment are used on 3 groups of people who will be selected after completing a questionnaire, which will deem them suitable for the study. They will, in fact, be divided into three groups where: - the first group was given a visceral osteopathic treatment. - The second group was given a manual osteopathic treatment of neurological stimulation. - The third group received a placebo treatment. At the end of the treatment, questionnaires will be re-proposed respectively one week after the session and one month after the treatment from which any data will be collected that will demonstrate the effectiveness or otherwise of the treatment received. The sample of 50 patients examined underwent an oral interview to evaluate the inclusion and exclusion criteria to participate in the study. Of the 50 patients questioned, 17 people who underwent different osteopathic techniques were eligible for the study. Comparing the data related to the first assessment of tenderness and frequency of symptoms with the data related to the first follow-up shows a significant improvement in the score assigned to the different questions, especially in the neurogenic and visceral groups. We are aware of the fact that it is a study performed on a small sample of patients, and this is a penalizing factor. We remain, however, convinced that having obtained good results in terms of subjective improvement in the quality of life of the subjects, it would be very interesting to re-propose the study on a larger sample and fill the gaps.

Keywords: IBS, osteopathy, colon, intestinal inflammation

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Authors: S. M. A. Ismail, M. I. Ibrahim, H. Masdar, F. M. Effendi, M. F. Suhaimi, A. Suun

Abstract:

Introduction: It is generally known that the rehabilitation process is as important as the reconstruction surgery. Several literature has focused on how early the rehabilitation modalities can be initiated after the surgery to ensure a safe return of patients to sports or at least regaining the pre-injury level of function following an ACL reconstruction. Objectives: The main objective is to study and evaluate the outcome of early balance exercises and agility training in sports rehabilitation for patients post ACL reconstruction. To compare between early balance exercises and agility training as intervention and control. (material or non-material). All of them were recruited for material exercise (balance exercises and agility training with strengthening) and strengthening only rehabilitation protocol (non-material). Followed the prospective intervention trial. Materials and Methods: Post-operative ACL reconstruction patients performed in Selayang and Sg Buloh Hospitals from 2012 to 2014 were selected for this study. They were taken from Malaysian Knee Ligament Registry (MKLR) and all patients had single bundle reconstruction with autograft hamstring tendon (semitendinosus and gracilis). ACL injury from any type of sports were included. Subjects performed various type of physical activity for rehabilitation in every 18 week for a different type of rehab activity. All subject attended all 18 sessions of rehabilitation exercises and evaluation was done during the first, 9th and 18th session. Evaluation format were based on clinical assessment (anterior drawer, Lachmann, pivot shift, laxity with rolimeter, the end point and thigh circumference) and scoring (Lysholm Knee scoring and Tegner Activity Level scale). Rehabilitation protocol initiated from 24 week after the surgery. Evaluation format were based on clinical assessment (anterior drawer, Lachmann, pivot shift, laxity with rolimeter, the end point and thigh circumference) and scoring (Lysholm Knee scoring and Tegner Activity Level scale). Results and Discussion: 100 patients were selected of which 94 patients are male and 6 female. Age range is 18 to 54 year with the average of 28 years old for included 100 patients. All patients are evaluated after 24 week after the surgery. 50 of them were recruited for material exercise (balance exercises and agility training with strengthening) and 50 for strengthening only rehabilitation protocol (non-material). Demographically showed 85% suffering sports injury mainly from futsal and football. 39 % of them have abnormal BMI (26 – 38) and involving of the left knee. 100% of patient had the basic radiographic x-ray of knee and 98% had MRI. All patients had negative anterior drawer’s, Lachman test and Pivot shift test during the post ACL reconstruction after the complete rehabilitation. There was 95 subject sustained grade I injury, 5 of grade II and 0 of grade III with 90% of them had soft end-point. Overall they scored badly on presentation with 53% of Lysholm score (poor) and Tegner activity score level 3/10. After completing 9 weeks of exercises, of material group 90% had grade I laxity, 75% with firm end-point, Lysholm score 71% (fair) and Tegner activity level 5/10 comparing non-material group who had 62% of grade I laxity , 54% of firm end-point, Lyhslom score 62 % (poor) and Tegner activity level 4/10. After completed 18 weeks of exercises, of material group maintained 90% grade I laxity with 100 % with firm end-point, Lysholm score increase 91% (excellent) and Tegner activity level 7/10 comparing non-material group who had 69% of grade I laxity but maintained 54% of firm end-point, Lysholm score 76% (fair) and Tegner activity level 5/10. These showed the improvement were achieved fast on material group who have achieved satisfactory level after 9th cycle of exercises 75% (15/20) comparing non-material group who only achieved 54% (7/13) after completed 18th session. Most of them were grade I. These concepts are consolidated into our approach to prepare patients for return to play including field testing and maintenance training. Conclusions: The basic approach in ACL rehabilitation is to ensure return to sports at post-operative 6 month. Grade I and II laxity has favourable and early satisfactory outcome base on clinical assessment and Lysholm and Tegner scoring point. Reduction of laxity grading indicates satisfactory outcome. Firm end-point showed the adequacy of rehabilitation before starting previous sports game. Material exercise (balance exercises and agility training with strengthening) were beneficial and reliable in order to achieve favourable and early satisfactory outcome comparing strengthening only (non-material).We have identified that rehabilitation protocol varies between different patients. Therefore future post ACL reconstruction rehabilitation guidelines should look into focusing on rehabilitation techniques instead of time.

Keywords: post anterior cruciate ligament (ACL) reconstruction, single bundle, hamstring tendon, sports rehabilitation, balance exercises, agility balance

Procedia PDF Downloads 233

Authors: P. C. Kutschera, Elena C. Tesoro, Mary Grace Talamera-Sandico, Jose Maria G. Pelayo III

Abstract:

Second generation military Filipino Amerasians comprise a formidable contemporary segment of the estimated 250,000-plus biracial Amerasians in the Philippines today. Overall, they are a stigmatized and socioeconomically marginalized diaspora, historically; they were abandoned or estranged by U.S. military personnel fathers assigned during the century-long Colonial, Post-World War II and Cold War Era of permanent military basing (1898-1992). Indeed, U.S. military personnel remain stationed in smaller numbers in the Philippines today. This inquiry is an outgrowth of two recent small sample studies. The first surfaced the impact of the U.S. military prostitution system on formation of the ‘Derivative Amerasian Family Construct’ on first generation Amerasians; a second, qualitative case study suggested the continued effect of the prostitution systems' destructive impetuous on second generation Amerasians. The intent of this current qualitative, multiple-case study was to actively seek out second generation sex industry toilers. The purpose was to focus further on this human phenomenon in the post-basing and post-military prostitution system eras. As background, the former military prostitution apparatus has transformed into a modern dynamic of rampant sex tourism and prostitution nationwide. This is characterized by hotel and resorts offering unrestricted carnal access, urban and provincial brothels (casas), discos, bars and pickup clubs, massage parlors, local barrio karaoke bars and street prostitution. A small case study sample (N = 4) of female and male second generation Amerasians were selected. Sample formation employed a non-probability ‘snowball’ technique drawing respondents from the notorious Angeles, Metro Manila, Olongapo City ‘AMO Amerasian Triangle’ where most former U.S. military installations were sited and modern sex tourism thrives. A six-month study and analysis of in-depth interviews of female and male sex laborers, their families and peers revealed a litany of disturbing, and troublesome experiences. Results showed profiles of debilitating human poverty, history of family disorganization, stigmatization, social marginalization and the ghost of the military prostitution system and its harmful legacy on Amerasian family units. Emerging were testimonials of wayward young people ensnared in a maelstrom of deep economic deprivation, familial dysfunction, psychological desperation and societal indifference. The paper recommends that more study is needed and implications of unstudied psychosocial and socioeconomic experiences of distressed younger generations of military Amerasians require specific research. Heretofore apathetic or disengaged U.S. institutions need to confront the issue and formulate activist and solution-oriented social welfare, human services and immigration easement policies and alternatives. These institutions specifically include academic and social science research agencies, corporate foundations, the U.S. Congress, and Departments of State, Defense and Health and Human Services, and Homeland Security (i.e. Citizen and Immigration Services) It is them who continue to endorse a laissez-faire policy of non-involvement over the entire Filipino Amerasian question. Such apathy, the paper concludes, relegates this consequential but neglected blood progeny to the status of humiliating destitution and exploitation. Amerasians; thus, remain entrapped in their former colonial, and neo-colonial habitat. Ironically, they are unwitting victims of a U.S. American homeland that fancies itself geo-politically as a strong and strategic military treaty ally of the Philippines in the Western Pacific.

Keywords: Asian Americans, diaspora, Filipino Amerasians, military prostitution, stigmatization

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Authors: Ziyad S. Haidar

Abstract:

Background: Saliva plays a major role in maintaining oral, dental, and general health and well-being; where it normally bathes the oral cavity acting as a clearing agent. This becomes more apparent when the amount and quality of saliva are significantly reduced due to medications, salivary gland neoplasms, disorders such as Sjögren’s syndrome, and especially ionizing radiation therapy for tumors of the head and neck, the 5th most common malignancy worldwide, during which the salivary glands are included within the radiation field/zone. Clinically, patients affected by salivary gland dysfunction often opt to terminate their radiotherapy course prematurely as they become malnourished and experience a significant decrease in their QoL. Accordingly, the formulation of a radio-protection/-prevention modality and development of an alternative Rx to restore damaged salivary gland tissue is eagerly awaited and highly desirable. Objectives: Assess the pre-clinical radio-protective effect and reparative/regenerative potential of layer-by-layer self-assembled lipid-polymer-based core-shell nanocapsules designed and fine-tuned for the sequential (ordered) release of dual cytokines, following a single local administration (direct injection) into a murine sub-mandibular salivary gland model of irradiation. Methods: The formulated core-shell nanocapsules were characterized by physical-chemical-mechanically pre-/post-loading with the drugs, followed by optimizing the pharmaco-kinetic profile. Then, nanosuspensions were administered directly into the salivary glands, 24hrs pre-irradiation (PBS, un-loaded nanocapsules, and individual and combined vehicle-free cytokines were injected into the control glands for an in-depth comparative analysis). External irradiation at an elevated dose of 18Gy was exposed to the head-and-neck region of C57BL/6 mice. Salivary flow rate (un-stimulated) and salivary protein content/excretion were regularly assessed using an enzyme-linked immunosorbent assay (3-month period). Histological and histomorphometric evaluation and apoptosis/proliferation analysis followed by local versus systemic bio-distribution and immuno-histochemical assays were then performed on all harvested major organs (at the distinct experimental end-points). Results: Monodisperse, stable, and cytocompatible nanocapsules capable of maintaining the bioactivity of the encapsulant within the different compartments with the core and shell and with controlled/customizable pharmaco-kinetics, resulted, as is illustrated in the graphical abstract (Figure) below. The experimental animals demonstrated a significant increase in salivary flow rates when compared to the controls. Herein, salivary protein content was comparable to the pre-irradiation (baseline) level. Histomorphometry further confirmed the biocompatibility and localization of the nanocapsules, in vivo, into the site of injection. Acinar cells showed fewer vacuoles and nuclear aberration in the experimental group, while the amount of mucin was higher in controls. Overall, fewer apoptotic activities were detected by a Terminal deoxynucleotidyl Transferase (TdT) dUTP Nick-End Labeling (TUNEL) assay and proliferative rates were similar to the controls, suggesting an interesting reparative and regenerative potential of irradiation-damaged/-dysfunctional salivary glands. The Figure below exemplifies some of these findings. Conclusions: Biocompatible, reproducible, and customizable self-assembling layer-by-layer core-shell delivery system is formulated and presented. Our findings suggest that localized sequential bioactive delivery of dual cytokines (in specific dose and order) can prevent irradiation-induced damage via reducing apoptosis and also has the potential to promote in situ proliferation of salivary gland cells; maxSALIVA is scalable (Good Manufacturing Practice or GMP production for human clinical trials) and patent-pending.

Keywords: cancer, head and neck, oncology, drug development, drug delivery systems, nanotechnology, nanoncology

Procedia PDF Downloads 54

Authors: Ziyad S. Haidar

Abstract:

Background: Saliva plays a major role in maintaining oral and dental health (consequently, general health and well-being). Where it normally bathes the oral cavity and acts as a clearing agent. This becomes more apparent when the amount and quality of salivare significantly reduced due to medications, salivary gland neoplasms, disorders such as Sjögren’s syndrome, and especially ionizing radiation therapy for tumors of the head and neck, the fifth most common malignancy worldwide, during which the salivary glands are included within the radiation field or zone. Clinically, patients affected by salivary gland dysfunction often opt to terminate their radiotherapy course prematurely because they become malnourished and experience a significant decrease in their quality of life. Accordingly, the development of an alternative treatment to restore or regenerate damaged salivary gland tissue is eagerly awaited. Likewise, the formulation of a radioprotection modality and early damage prevention strategy is also highly desirable. Objectives: To assess the pre-clinical radio-protective effect as well as the reparative/regenerative potential of layer-by-layer self-assembled lipid-polymer-based core-shell nanocapsules designed and fine-tuned in this experimental work for the sequential (ordered) release of dual cytokines, following a single local administration (direct injection) into a murine sub-mandibular salivary gland model of irradiation. Methods: The formulated core-shell nanocapsules were characterized by physical-chemical-mechanically pre-/post-loading with the drugs (in solution and powder formats), followed by optimizing the pharmaco-kinetic profile. Then, nanosuspensions were administered directly into the salivary glands, 24hrs pre-irradiation (PBS, un-loaded nanocapsules, and individual and combined vehicle-free cytokines were injected into the control glands for an in-depth comparative analysis). External irradiation at an elevated dose of 18Gy (revised from our previous 15Gy model) was exposed to the head-and-neck region of C57BL/6 mice. Salivary flow rate (un-stimulated) and salivary protein content/excretion were regularly assessed using an enzyme-linked immunosorbent assay (3-month period). Histological and histomorphometric evaluation and apoptosis/proliferation analysis followed by local versus systemic bio-distribution and immuno-histochemical assays were then performed on all harvested major organs (at the distinct experimental end-points). Results: Monodisperse, stable, and cytocompatible nanocapsules capable of maintaining the bioactivity of the encapsulant within the different compartments with the core and shell and with controlled/customizable pharmaco-kinetics, resulted, as is illustrated in the graphical abstract (Figure) below. The experimental animals demonstrated a significant increase in salivary flow rates when compared to the controls. Herein, salivary protein content was comparable to the pre-irradiation (baseline) level. Histomorphometry further confirmed the biocompatibility and localization of the nanocapsules, in vivo, into the site of injection. Acinar cells showed fewer vacuoles and nuclear aberration in the experimental group, while the amount of mucin was higher in controls. Overall, fewer apoptotic activities were detected by a Terminal deoxynucleotidyl Transferase (TdT) dUTP Nick-End Labeling (TUNEL) assay and proliferative rates were similar to the controls, suggesting an interesting reparative and regenerative potential of irradiation-damaged/-dysfunctional salivary glands. The Figure below exemplifies some of these findings. Conclusions: Biocompatible, reproducible, and customizable self-assembling layer-by-layer core-shell delivery system is formulated and presented. Our findings suggest that localized sequential bioactive delivery of dual cytokines (in specific dose and order) can prevent irradiation-induced damage via reducing apoptosis and also has the potential to promote in situ proliferation of salivary gland cells; maxSALIVA is scalable (Good Manufacturing Practice or GMP production for human clinical trials) and patent-pending.

Keywords: saliva, head and neck cancer, nanotechnology, controlled drug delivery, xerostomia, mucositis, biopolymers, innovation

Procedia PDF Downloads 62