Search results for: Pamela Ventola

Authors: Pamela Ventola, Laurel Bales, Sara Florczyk

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Background: Fully remote or hybrid administration of clinical outcome measures in rare neurodevelopmental disorders trials is increasing due to the ongoing pandemic and recognition that remote assessments reduce the burden on families. Many assessments in rare neurodevelopmental disorders trials are complex; however, remote/hybrid trials readily allow for the use of centralized raters to administer and score the scales. The use of centralized raters has many benefits, including reducing site burden; however, a specific impact on data quality has not yet been determined. Purpose: The current study has two aims: a) evaluate differences in data quality between administration of a standardized clinical interview completed by centralized raters compared to those completed by site raters and b) evaluate improvement in accuracy of scoring standardized developmental assessments when scored centrally compared to when scored by site raters. Methods: For aim 1, the Vineland-3, a widely used measure of adaptive functioning, was administered by site raters (n= 52) participating in one of four rare disease trials. The measure was also administered as part of two additional trials that utilized central raters (n=7). Each rater completed a comprehensive training program on the assessment. Following completion of the training, each clinician completed a Vineland-3 with a mock caregiver. Administrations were recorded and reviewed by a neuropsychologist for administration and scoring accuracy. Raters were able to certify for the trials after demonstrating an accurate administration of the scale. For site raters, 25% of each rater’s in-study administrations were reviewed by a neuropsychologist for accuracy of administration and scoring. For central raters, the first two administrations and every 10th administration were reviewed. Aim 2 evaluated the added benefit of centralized scoring on the accuracy of scoring of the Bayley-3, a comprehensive developmental assessment widely used in rare neurodevelopmental disorders trials. Bayley-3 administrations across four rare disease trials were centrally scored. For all administrations, the site rater who administered the Bayley-3 scored the scale, and a centralized rater reviewed the video recordings of the administrations and also scored the scales to confirm accuracy. Results: For aim 1, site raters completed 138 Vineland-3 administrations. Of the138 administrations, 53 administrations were reviewed by a neuropsychologist. Four of the administrations had errors that compromised the validity of the assessment. The central raters completed 180 Vineland-3 administrations, 38 administrations were reviewed, and none had significant errors. For aim 2, 68 administrations of the Bayley-3 were reviewed and scored by both a site rater and a centralized rater. Of these administrations, 25 had errors in scoring that were corrected by the central rater. Conclusion: In rare neurodevelopmental disorders trials, sample sizes are often small, so data quality is critical. The use of central raters inherently decreases site burden, but it also decreases rater variance, as illustrated by the small team of central raters (n=7) needed to conduct all of the assessments (n=180) in these trials compared to the number of site raters (n=53) required for even fewer assessments (n=138). In addition, the use of central raters dramatically improves the quality of scoring the assessments.

Keywords: neurodevelopmental disorders, clinical trials, rare disease, central raters, remote trials, decentralized trials

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Authors: Jerome Blackman, Pamela Franklin, Volha Roshchanka

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The US coal mining sector accounts for 6% of total US Methane emissions (2021). 60% of US coal mining methane emissions come from active underground mine ventilation systems. Abandoned mines contribute about 13% of methane emissions from coal mining. While there are thousands of abandoned underground coal mines in the US, the Environmental Protection Agency (EPA) estimates that fewer than 100 have sufficient methane resources for viable methane recovery and use projects. Many abandoned mines are in remote areas far from potential energy customers and may be flooded, further complicating methane recovery. Because these mines are no longer active, recovery projects can be simpler to implement.

Keywords: abandoned mines, coal mine methane, coal mining, methane emissions, methane mitigation, recovery and use

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Authors: Marco Avila Lopez, Hasnae Ait-Douchi, Silvia De Los Santos, Badr Eddine Lebrouhi, Pamela Ramírez Vidal

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In the context of the energy transition, fuel cell technology has emerged as a solution for harnessing hydrogen energy and mitigating greenhouse gas emissions. An in-depth study was conducted on a PEMFC-type fuel cell, with an initiation of an analysis of its operational principles and constituent components. Subsequently, the modelling of the fuel cell was undertaken using the Python programming language, encompassing both steady-state and transient regimes. In the case of the steady-state regime, the physical and electrochemical phenomena occurring within the fuel cell were modelled, with the assumption of uniform temperature throughout all cell compartments. Parametric identification was carried out, resulting in a remarkable mean error of only 1.62% when the model results were compared to experimental data documented in the literature. The dynamic model that was developed enabled the scrutiny of the fuel cell's response in terms of temperature and voltage under varying current conditions.

Keywords: fuel cell, modelling, dynamic, thermal model, PEMFC

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Authors: Gayus Pratama Polunggu, Pamela Felita Adibrata, Hafidh Fathur Riza

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Opak Fault is a large fault that extends from the northeast to the southwest of Yogyakarta Special Region. Opak Fault allegedly re-active after the 2006 Yogyakarta earthquake, about eleven years ago. Opak Fault is a big fault, therefore the activation will bring up the microstructure around the Opak River. This microstructure will reveal a different direction of force from the Opak Fault because the trigger for the emergence of the microstructure is the reactivation of the Opak Fault. In other words, this microstructure is a potentially severe weak area during a tectonic disaster. This research was conducted to find out the impact from the reactivation of Opak Fault that triggered the emergence of microstructure around Opak River which is very useful for disaster mitigation information around research area. This research used the approach from literature study in the form of the journal of structural geology and field study. The method used is a laboratory analysis in the form of stereographic analysis.

Keywords: Opak fault, reactivation, microstructure, stereographic

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Authors: Nathalia Florencia Barros Azeredo, Josué Martins Gonçalves, Pamela De Oliveira Rossini, Koiti Araki, Lucio Angnes

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This work demonstrates the electroanalysis of uric acid (UA) at very low working potential (0 V vs Ag/AgCl) directly in body fluids such as saliva and sweat using electrodes modified with mixed -Ni0.75Zn0.25(OH)2 nanoparticles exhibiting stable electrocatalytic responses from alkaline down to weakly acidic media (pH 14 to 3 range). These materials were prepared for the first time and fully characterized by TEM, XRD, and spectroscopic techniques. The electrochemical properties of the modified electrodes were evaluated in a fast and simple procedure for uric acid analyses based on cyclic voltammetry and chronoamperometry, pushing down the detection and quantification limits (respectively of 2.3*10-8 and 7.6*10-8 mol L-1) with good repeatability (RSD = 3.2% for 30 successive analyses pH 14). Finally, the possibility of real application was demonstrated upon realization of unexpectedly robust and sensitive modified FTO (fluorine doped tin oxide) glass and screen-printed sensors for measurement of uric acid directly in real saliva and sweat samples, with no significant interference of usual concentrations of ascorbic acid, acetaminophen, lactate and glucose present in those body fluids (Fig. 1).

Keywords: nickel hydroxide, mixed catalyst, uric acid sensors, biofluids

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Authors: Joella Mukashyaka, Rose Mukarubayiza, Emmanuel Habumugisha, Francois-Xavier Sunday, Kellen Muganwa, Valens Mbarushimana, Pamela Meharry

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Background: Breastfeeding in the first hour post-birth can decrease neonatal morbidity and mortality. Disease prevention and health outcomes differ immensely between newborns who receive human milk and those who do not. Rwanda has high breastfeeding rates, though factors associated with early initiation of breastfeeding (EIBF) are unknown. Objective: To assess factors associated with EIBF among mothers in immediate postpartum units at two hospitals. Methods: A cross-sectional study design and a convenience sample of 187 mothers were used. An interviewer-administered questionnaire was used for data collection. A Chi-square test showed the relationship between EIBF and sociodemographic factors. Results: The findings showed less than one quarter (20.5%) breastfed within the first hour after birth. The majority was < 25 years (52.4%), had some primary education (27.7%) employed (66.7%), urban dweller (58.1%), attendance of one ANC visit or more (81.3%), vaginal birth (58.8%), and did not receive EIBF health education (92.0%). The majority (78.5%) was too tired to initiate breastfeeding, and many supplemented (41.9%) due to perceived insufficient breastmilk. Conclusion: Most mothers did not initiate breastfeeding within the first hour after birth. Sociodemographic factors were associated with EIBF. A program to promote, protect, and support EIBF is urgently needed the community.

Keywords: breastfeeding, early initiation, neonates, morbidity, mortality, sub-Saharan Africa

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Authors: Samantha Borja, Vladimir Valle, Pamela Molina

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The development of adhesives from renewable raw materials attracts the attention of the scientific community, due to it promises the reduction of the dependence with materials derived from oil. This work proposes the use of modified 'oca (Oxalis tuberosa)' starch and polyvinyl alcohol (PVA) in the elaboration of adhesives for lignocellulosic substrates. The investigation focused on the formulation of adhesives with 3 different PVA:starch (modified and native) ratios (of 1,0:0,33; 1,0:1,0; 1,0:1,67). The first step to perform it was the chemical modification of starch through acid hydrolysis and a subsequent urea treatment to get carbamate starch. Then, the adhesive obtained was characterized in terms of instantaneous viscosity, Fourier-transform infrared spectroscopy (FTIR) and shear strength. The results showed that viscosity and mechanical tests exhibit data with the same tendency in relation to the native and modified starch concentration. It was observed that the data started to reduce its values to a certain concentration, where the values began to grow. On the other hand, two relevant bands were found in the FTIR spectrogram. The first in 3300 cm⁻¹ of OH group with the same intensity for all the essays and the other one in 2900 cm⁻¹, belonging to the group of alkanes with a different intensity for each adhesive. On the whole, the ratio PVA:starch (1:1) will not favor crosslinking in the adhesive structure and causes the viscosity reduction, whereas, in the others ones, the viscosity is higher. It was also observed that adhesives made with modified starch had better characteristics, but the adhesives with high concentrations of native starch could equal the properties of the adhesives made with low concentrations of modified starch.

Keywords: polyvinyl alcohol, PVA, chemical modification, starch, FTIR, viscosity, shear strength

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Authors: Badr Eddine Lebrouhi, Melissa Lopez Viveros, Silvia De Los Santos, Kolthoum Missaoui, Pamela Ramirez Vidal

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Since the Paris Climate Agreement, numerous countries, including France, have committed to achieving carbon neutrality by 2050 by enhancing renewable energy capacity and decarbonizing various sectors, including aviation. In this way, the Occitanie region aspires to become a renewable energy pioneer and has focused on Toulouse's Blagnac airport—a prominent hub characterized by high-energy demands. As part of a holistic strategy to reduce the airport's energy dependency, green hydrogen has emerged as a promising alternative fuel, offering the potential to significantly enhance aviation's environmental sustainability. This study assesses the technical and economic aspects of green hydrogen production, particularly its potential to replace fossil kerosene in aviation at Toulouse-Blagnac airport. It analyzes future liquid hydrogen fuel demand, calculates energy requirements for electrolysis and liquefaction, considers diverse renewable energy scenarios, and assesses the Levelized Cost of Hydrogen (LCOH) for economic viability. The research also projects LCOH evolution from 2023 to 2050, offering a comprehensive view of green hydrogen's feasibility as a sustainable aviation fuel, aligning with the region's renewable energy and sustainable aviation objectives.

Keywords: Toulouse-Blagnac Airport, green hydrogen, aviation decarbonization, electrolysis, renewable energy, technical-economic feasibility

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Authors: Peijen Pamela Chuang, Tzu-Hua Wang

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To address the notion of educational equity, undergo the global pandemic, a digital learning system was cross-disciplinarily designed by a 15-year-experienced teaching practitioner. A study was performed on students through the use of this pioneering e-learning system, in which Taiwanese students with different learning styles and special needs have a foreign language- English as the target subject. 121 students are particularly selected from an N= 580 sample spread across 20 inclusive and special education schools throughout districts of Taiwan. To bring off equity, the participants are selected from a mix of different socioeconomic statuses. Grouped data, such as classroom observation, individual learning preference, prerequisite knowledge, learning interest, and learning performance of the population, is carefully documented for further analyzation. The paper focuses on documenting the awareness and needs of this pedagogical methodology revolution, data analysis of UX (User Experience), also examination and system assessment of this system. At the time of the pilot run, this newly-developed e-learning system had successfully applied for and received a national patent in Taiwan. This independent research hoped to expand the awareness of the importance of individual differences in SDG4 (Substantial Development Goals 4) as a part of the ripple effect, and serve as a comparison for future scholars in the pedagogical research with an interdisciplinary approach.

Keywords: e-learning, educational equity, foreign language acquisition, inclusive education, individual differences, interdisciplinary innovation, learning preferences, SDG4

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Authors: Ghadeer M Alkusayer, Adelicia Yu, Pamela Orr

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Study objective: To report a case of postpartum pulmonary cryptococcal infection (CCI) in an otherwise healthy 35-year-old woman. Additionally, the cases of pulmonary cryptococcal infections either in the antepartum or the postpartum period with pregnancy outcomes, were systematically reviwed. Methods: A systematic search of Cochrane Library, MEDLINE, and EMBASE was conducted for peer-reviewed studies without date restrictions, published in English and relating to CCI during pregnancy or postpartum period. Conference press, editorials, opinion pieces and letters were excluded. Two authors independently screened citations and full-text articles, extracted data and assessed study quality. Given the heterogeneity of study designs, a narrative synthesis was conducted. Results: The search identified 128 references, of which 22 case reports and series met the inclusion criteria. This is a total of 29 women (including the current case) . The mean age of the women was 28.3 ± 12.3 years. Nine (31.03%) presented and were diagnosed in the postpartum period. Two (6.90%) of the patients were reported as immunocompromised with HIV. Four maternal deaths (13.79%) were found in this case series with one (4.3%) patient with severe neurological deficits. Four (17.4%) infant deaths were reported. Women primary presentation varied with chest pain 13 (44.82%), headache 10 (35.70%), dyspnea 19 (65.51%), or fever 12 (41.38%). Three studies reported placental pathology positive for C. neoformans. Conclusion: This case of pulmonary cryptococcal infection in the postpartum period is an important addition to the literature of this rare infection in pregnancy. The patient is not immunocompromised. The patient was successfully treated with 4 months of Fluconazole 400 mg and continued to breastfeed the healthy baby.

Keywords: pulmonary cryptococcus, pregnancy, cryptococci , postpartum

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Authors: Isaiah Phillip Smith, Sam Erevbenagie Usadolo, Pamela Theresa Tancsik

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This paper is part of ongoing doctoral research that examines the role of Theatre for Development (TfD) in addressing climate change in the Mosuthu community in Reservoir Hills, Durban, South Africa. The context of the research underscores the pressing challenges facing South Africa, including drought, water shortages, deterioration of land, and civil unrest that require innovative approaches to the mitigation of climate change. TfD, described as a dialogical form of theatre that allows communities to express and contribute to development, emerges as a strategic medium for engaging communities in the process. The research problem focused on the unexamined potential of TfD in promoting community involvement and critical awareness of climate change. The study objectives included assessing the community's understanding of climate change, exploring TfD's potential as a participatory tool, examining its role in community mobilization, and developing recommendations for its effective implementation. A review of relevant literature and preliminary investigations in the research community indicates that TfD is an effective medium for promoting societal transformation and engaging marginalized communities. Through culturally resonant narratives, TfD can instill a deeper understanding of environmental challenges, fostering empathy and motivating behavioural changes. By integrating community voices and cultural elements, TfD serves as a powerful catalyst for promoting climate change awareness and inspiring collective action within the South African context. This research contributes to the global discourse on innovative approaches to climate change awareness and action.

Keywords: TfD, climate change, community involvement, societal transformation, culture

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Authors: Glebert C. Dadol, Pamela Mae L. Ucab, Camila Flor Y. Lobarbio, Noel Peter B. Tan

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Water scarcity is a global problem and membrane-based desalination technologies are one of the promising solutions to this problem. In this study, a passive solar-driven membrane distiller was fabricated and tested for its desalination performance. The distiller was composed of a TiNOX plate solar absorber, cellulose-based upper and lower hydrophilic layers, a hydrophobic middle layer, and aluminum heatsinks. The effect of the middle layer material and thickness on the desalination performance was investigated in terms of distillate productivity and salinity. The materials used for the middle layer were a screen mesh (2 mm, 4 mm, 6 mm thickness) to generate an air gap, a PTFE membrane (0.3 mm thickness)), and a combination of the screen mesh and the PTFE membrane (2.3 mm total thickness). Salt water (35 g/L NaCl) was desalinated using the distiller at a rooftop setting at the University of San Carlos, Cebu City, Philippines. The highest distillate productivity of 1.08 L/m2-h was achieved using a 2-mm screen mesh (air gap) but it also resulted in a high distillate salinity of 25.20 g/L. Increasing the thickness of the air gap lowered the distillate salinity but also decreased the distillate productivity. The lowest salinity of 1.07 g/L was achieved using a 6-mm air gap but the productivity was reduced to 0.08 L/m2-h. The use of the hydrophobic PTFE membrane increased the productivity (0.44 L/m2-h) compared to a 6-mm air gap but produced a distillate with high salinity (16.68 g/L). When using a combination of the screen mesh and the PTFE membrane, the productivity was 0.13 L/m2-h and a distillate salinity of 1.61 g/L. The distiller with a thick air gap as the middle layer can deliver a distillate with low salinity and is preferred over a thin hydrophobic PTFE membrane. The use of a combination of the air gap and PTFE membrane slightly increased the productivity with comparable distillate salinity. Modifications and optimizations to the distiller can be done to improve further its performance.

Keywords: desalination, membrane distillation, passive solar-driven membrane distiller, solar distillation

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Authors: Pamela E. Mukaire

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Anemia and chronic energy deficiency are significant manifestations of poor nutritional health. Anaemia and nutritional status screening are practical ways for assessing the prevalence of iron deficiency anemia in the food insecure populations with large groups of childbearing women and children. The objective of the study was to assess anemia prevalence and other clinical manifestations of malnutrition among pairs of mothers and young children in rural Uganda. This community cross-sectional study used consecutive sampling to select 214 mothers and 214 children for the study. Data was generated using structured questionnaire, anthropometric measurements and on site analysis for anemia. Bivariable and multivariable analyses were used to assess the effect of different factors on anaemia. Of the 214 mothers, 54.2% were 25-34 years of age, 76.7% unmarried, 63% low income, and 55% had more than four children. Of the 214 children, 57% were female, 50% between 1 to 3 years of age and 35% under one year, and. Overall, 38% of the households had more 4 children under the age of 12. The prevalence of anemia was 48% for mothers and 72% for children; 20.6% of mothers had moderate to severe chronic energy deficiency, 39% had moderately-severe anaemia (10 to 7.1 g/dL). Among children, 53% had moderately-severe anaemia, and 18.2% had severe anaemia. Parity X2 =20, p < .037, number of children under 12 years living in a household X2 =10, p < .015, and child’s gender X2 =6.5, p < .038, had a significant relationship with maternal anaemia. There was a significant relationship between household income X2 =10, p < .005, marital status X2 =9, p < .011, owing a piece of land X2 =18, p < .000, owing home X2 =7, p < .036, and anaemia in children. The prevalence of anemia was high in both mothers and children. Income, marital status, owing a piece of land, owing home, number of children under age 12 in a household were associated with anaemia. Hence, efforts should be made for early diagnosis and management of anaemia deficiencies with special emphasis on those households with large number of children under age 12.

Keywords: anemia, maternal-child, nutrition, rural population

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Authors: Tettey Afi Pamela, Sotaro Fujii, Hidetoshi Saito, Kawaii Koichiro

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Introduction: Organisms employ adaptive mechanisms when faced with any stressor or risk of being wiped out. This has made it possible for them to survive in harsh environmental conditions such as increasing temperature, low pH, and anoxia. Some of the mechanisms they utilize include the expression of heat shock proteins, synthesis of cryoprotectants, and anhydrobiosis. Heat shock proteins (HSPs) have been widely studied to determine their involvement in stress tolerance among various organism, of which chironomid species have been no exception. We examined the survival and expression of genes encoding five (5) heat shock proteins (HSP70, HSP67, HSP60, HSP27, and HSP23) from Chironomus sulfurosus larvae reared from 1st instar at 25°C, 30°C, 35°C, and 40°C. Results: The highest survival rate was recorded at 30°C, followed by 25°C, then 35°C. Only a small percentage of C. sulfurosus survived at 40°C (14.5%). With regards to HSPs expression, some HSPs responded to an increase in high temperature. The relative expression levels were lowest at 30°C for HSP70, HSP60, HSP27, and HSP23. At 25°C and 40°C, HSP70, HSP67, HSP60, HSP27, and HSP23 had the highest expression. At 35°C, all had the lowest expression. Discussion: The expression of heat shock proteins varies from one species to another. We designated the genes HSP 70, HSP 67, HSP 60, HSP 27, and HSP 23 genes based on transcriptome analysis of C. sulfurosus. Our study can be termed as a long-heat shock study as C. sulfurosus was reared from the first instar to the fourth instar, and this might have led to a continuous induction of HSPs at 25°C. 40°C had the lowest survival but highest HSPs expression as C. sulfurosus larvae had to utilize HSPs for sustenance. These results and future high-throughput studies at both the transcriptome and proteome level will improve the information needed to predict the future geographic distribution of these species within the context of global warming.

Keywords: chironomid, heat shock proteins, high temperature, heat shock protein expression

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Authors: Tamara Jimah, Priscilla Kehoe, Pamela Pimentel, Amir Rahmani, Nikil Dutt, Yuqing Guo

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Ensuring equitable access to maternal health care is critical for public health. Particularly for underserved women, community health workers (CHWs) have been invaluable in providing support through health education and strategies for improved maternal self-care management. Our research aimed to assess the acceptance of technology by CHWs and perinatal women to promote healthy pregnancy and postpartum wellness. This pilot study was conducted at a local community organization in Orange County, California, where CHWs play an important role in supporting low-income women through home visitations. Questionnaires were administered to 14 CHWs and 114 pregnant and postpartum women, literate in English and/or Spanish. CHWs tested two wearable devices (Galaxy watch and Oura ring) and shared their user experience, including potential reception by the perinatal women they served. In addition, perinatal women provided information on access to a smart phone and the internet, as well as their interest in using wearable devices to self-monitor personal health with guidance from a CHW. Over 85% of CHWs agreed that it was useful to track pregnancy with the smart watch and ring. The majority of perinatal women owned a smartphone (97.4%), had access to the internet (80%) and unlimited data plans (78%), expressed interest in using the smart wearable devices to self-monitor health, and were open to receiving guidance from a CHW (87%). Community health workers and perinatal women embraced the use of wearable technology to monitor maternal health. These preliminary findings have formed the basis of an ongoing research study that integrates CHW guidance and technology (i.e., smart watch, smart ring, and a mobile phone app) to promote self-efficacy and self-management among underserved perinatal women.

Keywords: community health workers, health promotion and education, health equity, maternal and child health, technology

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Authors: Wighens Ngoie Ilunga, Pamela J. Welz, Olewaseun O. Oyekola, Daniel Ikhu-Omoregbe

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Currently, most sludge from the wastewater treatment plants of edible oil factories is disposed to landfills, but landfill sites are finite and potential sources of environmental pollution. Production of biodiesel from wastewater sludge can contribute to energy production and waste minimization. However, conventional biodiesel production is energy and waste intensive. Generally, biodiesel is produced from the transesterification reaction of oils with alcohol (i.e., Methanol, ethanol) in the presence of a catalyst. Homogeneously catalysed transesterification is the conventional approach for large-scale production of biodiesel as reaction times are relatively short. Nevertheless, homogenous catalysis presents several challenges such as high probability of soap. The current study aimed to reuse wastewater sludge from the edible oil industry as a novel feedstock for both monounsaturated fats and bioethanol for the production of biodiesel. Preliminary results have shown that the fatty acid profile of the oilseed wastewater sludge is favourable for biodiesel production with 48% (w/w) monounsaturated fats and that the residue left after the extraction of fats from the sludge contains sufficient fermentable sugars after steam explosion followed by an enzymatic hydrolysis for the successful production of bioethanol [29% (w/w)] using a commercial strain of Saccharomyces cerevisiae. A novel nano-magnetic catalyst was synthesised from mineral processing alkaline tailings, mainly containing dolomite originating from cupriferous ores using a modified sol-gel. The catalyst elemental chemical compositions and structural properties were characterised by X-ray diffraction (XRD), scanning electron microscopy (SEM), Fourier transform infra-red (FTIR) and the BET for the surface area with 14.3 m²/g and 34.1 nm average pore diameter. The mass magnetization of the nano-magnetic catalyst was 170 emu/g. Both the catalytic properties and reusability of the catalyst were investigated. A maximum biodiesel yield of 78% was obtained, which dropped to 52% after the fourth transesterification reaction cycle. The proposed approach has the potential to reduce material costs, energy consumption and water usage associated with conventional biodiesel production technologies. It may also mitigate the impact of conventional biodiesel production on food and land security, while simultaneously reducing waste.

Keywords: biodiesel, bioethanol, edible oil wastewater sludge, nano-magnetism

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Authors: Pamela-Zoe Topalli, Niina Junttila, Päivi M. Niemi, Klaus Ranta

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Adolescents’ biased perceptions about their social competence (SC), whether negatively or positively, serve to influence their socioemotional adjustment such as early feelings of social phobia (nowadays referred to as Social Anxiety Disorder-SAD). Despite the importance of biased self-perceptions in adolescents’ psychosocial adjustment, the extent to which discrepancies between self- and others’ evaluations of one’s SC are linked to social phobic symptoms remains unclear in the literature. This study examined the perceptual discrepancy profiles between self- and peers’ as well as between self- and teachers’ evaluations of adolescents’ SC and the interrelations of these profiles with self-reported social phobic symptoms. The participants were 390 3^rd graders (15 years old) of Finnish lower secondary school (50.8% boys, 49.2% girls). In contrast with variable-centered approaches that have mainly been used by previous studies when focusing on this subject, this study used latent profile analysis (LPA), a person-centered approach which can provide information regarding risk profiles by capturing the heterogeneity within a population and classifying individuals into groups. LPA revealed the following five classes of discrepancy profiles: i) extremely negatively biased perceptions of SC, ii) negatively biased perceptions of SC, iii) quite realistic perceptions of SC, iv) positively biased perceptions of SC, and v) extremely positively biased perceptions of SC. Adolescents with extremely negatively biased perceptions and negatively biased perceptions of their own SC reported the highest number of social phobic symptoms. Adolescents with quite realistic, positively biased and extremely positively biased perceptions reported the lowest number of socio-phobic symptoms. The results point out the negatively and the extremely negatively biased perceptions as possible contributors to social phobic symptoms. Moreover, the association of quite realistic perceptions with low number of social phobic symptoms indicates its potential protective power against social phobia. Finally, positively and extremely positively biased perceptions of SC are negatively associated with social phobic symptoms in this study. However, the profile of extremely positively biased perceptions might be linked as well with the existence of externalizing problems such as antisocial behavior (e.g. disruptive impulsivity). The current findings highlight the importance of considering discrepancies between self- and others’ perceptions of one’s SC in clinical and research efforts. Interventions designed to prevent or moderate social phobic symptoms need to take into account individual needs rather than aiming for uniform treatment. Implications and future directions are discussed.

Keywords: adolescence, latent profile analysis, perceptual discrepancies, social competence, social phobia

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Authors: Pamela K. Coke, Heidi Frederiksen, Ann Sebald

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Over the past three years, the researchers have been tracking a rise in the number of teacher education candidates leaving the field before completing their university’s educator preparation program. At their institution, this rise is most pronounced in English Education. The purpose of this qualitative research study is to understand English Education teacher candidates' expectations in becoming prepared educators at each phase of their four phase teacher education program at one institution of higher education in the United States. Research questions include: To what extent do we find differences in teacher candidates' expectations of their teacher training program and student teaching experiences based upon undergraduate and graduate programs? Why do (or do not) teacher candidates persist in their teacher training program and student teaching experiences? How do dispositions develop through the course of the teacher training program? What supports do teacher candidates self-identify as needing at each phase of the teacher training program? Based upon participant interviews at each phase of the teacher education program, the researchers, all teacher educators, examine the extent to which English Education students feel prepared to student teach, focusing on preparation, persistence, and dispositions. The Colorado State University Center for Educator Preparation (CEP) provides students with information about teaching dispositions, or desired professional behaviors, throughout their education program. CEP focuses these dispositions around nine categories: Professional Behaviors, Initiative and Dependability, Tact and Judgment, Ethical Behavior and Integrity, Collegiality and Responsiveness, Effective Communicator, Desire to Improve Own Performance, Culturally Responsive, and Commitment to the Profession. Currently, in the first phase of a four phase study, initial results indicate participants expect their greatest joys will be working with and learning from students. They anticipate their greatest challenges will involve discipline and confidence. They predict they will persist in their program because they believe the country needs well-prepared teachers and they have a commitment to their professional growth. None of the participants thus far could imagine why they would leave the program. With regard to strongest and weakest dispositions, results are mixed. Some participants see Tact and Judgment as their strongest disposition; others see it as their weakest. All participants stated mentoring is a necessary support at every phase of the teacher preparation process. This study informs the way teacher educators train and evaluate teacher candidates, and has implications for the frequency and types of feedback students receive from mentors and supervisors. This research contributes to existing work on teacher retention, candidate persistence, and dispositional development.

Keywords: English education, dispositions, persistence, teacher preparation

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Authors: Pamela R. Jackson, Andrea Hawkins-Daarud, Cassandra R. Rickertsen, Kamala Clark-Swanson, Scott A. Whitmire, Kristin R. Swanson

Abstract:

Glioblastoma Multiforme (GBM), the most common primary brain tumor, often presents with hyperintensity on T2-weighted or T2-weighted fluid attenuated inversion recovery (T2/FLAIR) magnetic resonance imaging (MRI). This hyperintensity corresponds with vasogenic edema, however there are likely many infiltrating tumor cells within the hyperintensity as well. While MRIs do not directly indicate tumor cells, MRIs do reflect the microenvironmental water abnormalities caused by the presence of tumor cells and edema. The inherent heterogeneity and resulting MRI features of GBMs complicate assessing disease response. To understand how hyperintensity on T2/FLAIR MRI may correlate with edema in the extracellular space (ECS), a multi-compartmental MRI signal equation which takes into account tissue compartments and their associated volumes with input coming from a mathematical model of glioma growth that incorporates edema formation was explored. The reasonableness of two possible extracellular space schema was evaluated by varying the T2 of the edema compartment and calculating the possible resulting T2s in tumor and peripheral edema. In the mathematical model, gliomas were comprised of vasculature and three tumor cellular phenotypes: normoxic, hypoxic, and necrotic. Edema was characterized as fluid leaking from abnormal tumor vessels. Spatial maps of tumor cell density and edema for virtual tumors were simulated with different rates of proliferation and invasion and various ECS expansion schemes. These spatial maps were then passed into a multi-compartmental MRI signal model for generating simulated T2/FLAIR MR images. Individual compartments’ T2 values in the signal equation were either from literature or estimated and the T2 for edema specifically was varied over a wide range (200 ms – 9200 ms). T2 maps were calculated from simulated images. T2 values based on simulated images were evaluated for regions of interest (ROIs) in normal appearing white matter, tumor, and peripheral edema. The ROI T2 values were compared to T2 values reported in literature. The expanding scheme of extracellular space is had T2 values similar to the literature calculated values. The static scheme of extracellular space had a much lower T2 values and no matter what T2 was associated with edema, the intensities did not come close to literature values. Expanding the extracellular space is necessary to achieve simulated edema intensities commiserate with acquired MRIs.

Keywords: extracellular space, glioblastoma multiforme, magnetic resonance imaging, mathematical modeling

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Authors: Fredrick Forster, Gareth Ward, Matthew Tubby, Pamela Lithgow, Anne Nortcliffe

Abstract:

This paper presents the results from a research study of random adult participants accessing one of four different commercially available Virtual Reality (VR) Head Mounted Displays (HMDs) and completing a post user experience reflection questionnaire. The research sort to understand how inclusive commercially available VR HMDs are and identify any associated barriers that could impact the widespread adoption of the devices, specifically in Higher Education (HE). In the UK, education providers are legally required under the Equality Act 2010 to ensure all education facilities are inclusive and reasonable adjustments can be applied appropriately. The research specifically aimed to identify the considerations that academics and learning technologists need to make when adopting the use of commercial VR HMDs in HE classrooms, namely cybersickness, user comfort, Interpupillary Distance, inclusiveness, and user perceptions of VR. The research approach was designed to build upon previously published research on user reflections on presence, usability, and overall HMD comfort, using quantitative and qualitative research methods by way of a questionnaire. The quantitative data included the recording of physical characteristics such as the distance between eye pupils, known as Interpupillary Distance (IPD). VR HMDs require each user’s IPD measurement to enable the focusing of the VR HMDs virtual camera output to the right position in front of the eyes of the user. In addition, the questionnaire captured users’ qualitative reflections and evaluations of the broader accessibility characteristics of the VR HMDs. The initial research activity was accomplished by enabling a random sample of visitors, staff, and students at Canterbury Christ Church University, Kent to use a VR HMD for a set period of time and asking them to complete the post user experience questionnaire. The study identified that there is little correlation between users who experience cyber sickness and car sickness. Also, users with a smaller IPD than average (typically associated with females) were able to use the VR HMDs successfully; however, users with a larger than average IPD reported an impeded experience. This indicates that there is reduced inclusiveness for the tested VR HMDs for users with a higher-than-average IPD which is typically associated with males of certain ethnicities. As action education research, these initial findings will be used to refine the research method and conduct further investigations with the aim to provide verification and validation of the accessibility of current commercial VR HMDs. The conference presentation will report on the research results of the initial study and subsequent follow up studies with a larger variety of adult volunteers.

Keywords: virtual reality, education technology, inclusive technology, higher education

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Authors: Pamela Del Rosario, Elisabetta Palumbo, Marzia Traverso

Abstract:

The building sector plays an important role in addressing pressing environmental issues such as climate change and resource scarcity. The energy performance of buildings is considerably affected by the external envelope. In fact, a considerable proportion of the building energy demand is due to energy losses through the windows. Nevertheless, according to literature, to pay attention only to the contribution of windows to the building energy performance, i.e., their influence on energy use during building operation, could result in a partial evaluation. Hence, it is important to consider not only the building energy performance but also the environmental performance of windows, and this not only during the operational stage but along its complete life cycle. Life Cycle Assessment (LCA) according to ISO 14040:2006 and ISO 14044:2006+A1:2018 is one of the most adopted and robust methods to evaluate the environmental performance of products throughout their complete life cycle. This life-cycle based approach avoids the shift of environmental impacts of a life cycle stage to another, allowing to allocate them to the stage in which they originated and to adopt measures that optimize the environmental performance of the product. Moreover, the LCA method is widely implemented in the construction sector to assess whole buildings as well as construction products and materials. LCA is regulated by the European Standards EN 15978:2011, at the building level, and EN 15804:2012+A2:2019, at the level of construction products and materials. In this work, the environmental performance of wooden windows was assessed by implementing the LCA method and adopting primary data. More specifically, the emphasis is given to embedded and operational impacts. Furthermore, correlations are made between these environmental impacts and aspects such as type of wood and window transmittance. In the particular case of the operational impacts, special attention is set on the definition of suitable maintenance scenarios that consider the potential climate influence on the environmental impacts. For this purpose, a literature review was conducted, and expert consultation was carried out. The study underlined the variability of the embedded environmental impacts of wooden windows by considering different wood types and transmittance values. The results also highlighted the need to define appropriate maintenance scenarios for precise assessment results. It was found that both the service life and the window maintenance requirements in terms of treatment and its frequency are highly dependent not only on the wood type and its treatment during the manufacturing process but also on the weather conditions of the place where the window is installed. In particular, it became evident that maintenance-related environmental impacts were the highest for climate regions with the lowest temperatures and the greatest amount of precipitation.

Keywords: embedded impacts, environmental performance, life cycle assessment, LCA, maintenance stage, operational impacts, wooden windows

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Authors: Pamela Aimee Rigor

Abstract:

This study aims to examine the representation of Syrian refugees resettled in Vancouver and the Lower Mainland in local community and major newspapers. While there is strong support for immigration in Canada, public opinion towards refugees and asylum seekers is a bit more varied. Concerns about the legitimacy of refugee claims are among the common concerns of Canadians, and hateful or negative narratives are still present in Canadian media discourse which affects how people view refugees. To counter the narratives, these Syrian refugees must publicly declare how grateful they are because they are resettled in Canada. The dominant media discourse is that these refugees should be grateful as they have been graciously accepted by Canada and Canadians, once again upholding the image of Canada being a generous and humanitarian nation. The study examined the representation of Syrian refugees and the Syrian refugee resettlement in Canadian newspapers from September 2015 to October 2017 – around the time Prime Minister Trudeau came into power up until the present. Using a combination of content and discourse analysis, it aimed to uncover how local community and major newspapers in Vancouver covered the Syrian refugee ‘crisis’ – more particularly, the arrival and resettlement of the refugees in the country. Using the qualitative data analysis software Nvivo 12, the newspapers were analyzed and sorted into themes. Based on the initial findings, the discourse of Canada being a humanitarian country and Canadians being generous, as well as the idea of Syrian refugees having to publicly announce how grateful they are, is still present in the local community newspapers. This seems to be done to counter the hateful narratives of citizens who might view them as people who are abusing help provided by the community or the services provided by the government. However, compared to the major and national newspapers in Canada, many these local community newspapers are very inclusive of Syrian refugee voices. Most of the News and Community articles interview Syrian refugees and ask them their personal stories of plight, survival, resettlement and starting a ‘new life’ in Canada. They are not seen as potential threats nor are they dismissed – the refugees were named and were allowed to share their personal experiences in these news articles. These community newspapers, even though their representations are far from perfect, actually address some aspects of the refugee resettlement issue and respond to their community’s needs. There are quite a number of news articles that announce community meetings and orientations about the Syrian refugee crisis, ways to help in the resettlement process, as well as community fundraising activities to help sponsor refugees or resettle newly arrived refugees. This study aims to promote awareness of how these individuals are socially constructed so we can, in turn, be aware of the certain biases and stereotypes present, and its implications on refugee laws and public response to the issue.

Keywords: forced migration and conflict, media representations, race and multiculturalism, refugee studies

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Authors: Regis Pochon, Nicolas Stefaniak, Veronique Baltazart, Pamela Gobin

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Anxiety is known to have an impact on working memory. In reasoning or memory tasks, individuals with anxiety tend to show longer response times and poorer performance. Furthermore, there is a memory bias for negative information in anxiety. Given the crucial role of working memory in lexical learning, anxious students may encounter more difficulties in learning to read and spell. Anxiety could even affect an earlier learning, that is the activation of phonological representations, which are decisive for the learning of reading and writing. The aim of this study is to compare the access to phonological representations of beginning readers and writers according to their level of anxiety, using an auditory lexical decision task. Eighty students of 6- to 9-years-old completed the French version of the Revised Children's Manifest Anxiety Scale and were then divided into four anxiety groups according to their total score (Low, Median-Low, Median-High and High). Two set of eighty-one stimuli (words and non-words) have been auditory presented to these students by means of a laptop computer. Stimuli words were selected according to their emotional valence (positive, negative, neutral). Students had to decide as quickly and accurately as possible whether the presented stimulus was a real word or not (lexical decision). Response times and accuracy were recorded automatically on each trial. It was anticipated a) longer response times for the Median-High and High anxiety groups in comparison with the two others groups, b) faster response times for negative-valence words in comparison with positive and neutral-valence words only for the Median-High and High anxiety groups, c) lower response accuracy for Median-High and High anxiety groups in comparison with the two others groups, d) better response accuracy for negative-valence words in comparison with positive and neutral-valence words only for the Median-High and High anxiety groups. Concerning the response times, our results showed no difference between the four groups. Furthermore, inside each group, the average response times was very close regardless the emotional valence. Otherwise, group differences appear when considering the error rates. Median-High and High anxiety groups made significantly more errors in lexical decision than Median-Low and Low groups. Better response accuracy, however, is not found for negative-valence words in comparison with positive and neutral-valence words in the Median-High and High anxiety groups. Thus, these results showed a lower response accuracy for above-median anxiety groups than below-median groups but without specificity for the negative-valence words. This study suggests that anxiety can negatively impact the lexical processing in young students. Although the lexical processing speed seems preserved, the accuracy of this processing may be altered in students with moderate or high level of anxiety. This finding has important implication for the prevention of reading and spelling difficulties. Indeed, during these learnings, if anxiety affects the access to phonological representations, anxious students could be disturbed when they have to match phonological representations with new orthographic representations, because of less efficient lexical representations. This study should be continued in order to precise the impact of anxiety on basic school learning.

Keywords: anxiety, emotional valence, childhood, lexical access

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Authors: Pamela Chia, Tay Yoong Chuan

Abstract:

Introduction: Severe pulmonary hypertension (PH) patients requiring non-cardiac surgery risk have increased mortality rates ranging. These patients are plagued with cardiorespiratory failure, dysrhythmias and anticoagulation potentially with concurrent sepsis and renal insufficiency, perioperative morbidity. We present a deaf-mute patient with severe idiopathic PH emergently prepared for ruptured ectopic laparotomy. Case Report: A 20 year-old female, 62kg (BMI 25 kg/m2) with severe idiopathic PH (2DE Ejection Fraction was 41%, Pulmonary Artery Systolic Pressure (PASP) 105 mmHg, Right ventricle strain and hypertrophy) and selective mutism was rushed in for emergency laparotomy after presenting to the emergency department for abdominal pain. The patient had an NYHA Class II with room air SpO2 93-95%. While awaiting lung transplant, the patient takes warfarin, Sildanefil, Macitentan and even Selexipag for rising PASP. At presentation, vital signs: BP 95/63, HR 119 SpO2 88% (room air). Despite decreasing haemoglobin 14 to 10g/dL, INR 2.59 was reversed with prothrombin concentrate, and Vitamin K. ECG revealed Right Bundle Branch Block with right ventricular strain and x-ray showed cardiomegaly, dilated Right Ventricle, Pulmonary Arteries, basal atelectasis. Arterial blood gas showed compensated metabolic acidosis pH 7.4 pCO2 32 pO2 53 HCO3 20 BE -4 SaO2 88%. The cardiothoracic surgeon concluded no role for Extracorporeal Membrane Oxygenation (ECMO). We inserted invasive arterial and central venous lines with blood transfusion via an 18G cannula before the patient underwent a midline laparotomy, haemostasis of ruptured ovarian cyst with 2.4L of clots under general anesthesia and FloTrac cardiac output monitoring. Rapid sequence induction was done with Midazolam/Propofol, remifentanil infusion, and rocuronium. The patient was maintained on Desflurane. Blood products and colloids were transfused for further 1.5L blood loss. Postoperatively, the patient was transferred to the intensive care unit and was extubated uneventfully 7hours later. The patient went home a week later. Discussion: Emergency hemostasis laparotomy in anticoagulated WHO Class I PH patient awaiting lung transplant with no ECMO backup poses tremendous stress on the deaf-mute patient and the anesthesiologist. Balancing hemodynamics avoiding hypotension while awaiting hemostasis in the presence of pulmonary arterial dilators and anticoagulation requires close titration of volatiles, which decreases RV contractility. We review the contraindicated anesthetic agents (ketamine, N2O), choice of vasopressors in hypotension to maintain Aortic-right ventricular pressure gradients and nitric oxide use perioperatively. Conclusion: Interdisciplinary communication with a deaf-mute moribund patient and anesthesia considerations pose many rare challenges worth sharing.

Keywords: pulmonary hypertension, case report, warfarin reversal, emergency surgery

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Authors: Pamela Tancsik

Abstract:

The stage production in 2018, titled ‘From‘Marikana to Mahagonny’, began with a prologue in the form of the award-winning documentary ‘Miners Shot Down' by Rehad Desai, followed by Brecht/Weill’s song play or scenic cantata ‘Mahagonny’, premièred in Baden-Baden 1927. The central directorial concept of the DUT musical production ‘From Marikana to Mahagonny’ was to show a connection between the socio-political alienation of mineworkers in present-day South Africa and Brecht’s alienation effect in his scenic cantata ‘Mahagonny’. Marikana is a mining town about 50 km west of South Africa’s capital Pretoria. Mahagonny is a fantasy name for a utopian mining town in the United States. The characters, setting, and lyrics refer to America with of songs like ‘Benares’ and ‘Moon of Alabama’ and the use of typical American inventions such as dollars, saloons, and the telephone. The six singing characters in ‘Mahagonny’ all have typical American names: Charlie, Billy, Bobby, Jimmy, and the two girls they meet later are called Jessie and Bessie. The four men set off to seek Mahagonny. For them, it is the ultimate dream destination promising the fulfilment of all their desires, such as girls, alcohol, and dollars – in short, materialistic goals. Instead of finding a paradise, they experience how money and the practice of exploitive capitalism, and the lack of any moral and humanity is destroying their lives. In the end, Mahagonny gets demolished by a hurricane, an event which happened in 1926 in the United States. ‘God’ in person arrives disillusioned and bitter, complaining about violent and immoral mankind. In the end, he sends them all to hell. Charlie, Billy, Bobby, and Jimmy reply that this punishment does not mean anything to them because they have already been in hell for a long time – hell on earth is a reality, so the threat of hell after life is meaningless. Human life was also taken during the stand-off between striking mineworkers and the South African police on 16 August 2012. Miners from the Lonmin Platinum Mine went on an illegal strike, equipped with bush knives and spears. They were striking because their living conditions had never improved; they still lived in muddy shacks with no running water and electricity. Wages were as low as R4,000 (South African Rands), equivalent to just over 200 Euro per month. By August 2012, the negotiations between Lonmin management and the mineworkers’ unions, asking for a minimum wage of R12,500 per month, had failed. Police were sent in by the Government, and when the miners did not withdraw, the police shot at them. 34 were killed, some by bullets in their backs while running away and trying to hide behind rocks. In the musical play ‘From Marikana to Mahagonny’ audiences in South Africa are confronted with a documentary about Marikana, followed by Brecht/Weill’s scenic cantata, highlighting the tragic parallels between the Mahagonny story and characters from 1927 America and the Lonmin workers today in South Africa, showing that in 95 years, capitalism has not changed.

Keywords: alienation, brecht/Weill, mahagonny, marikana/South Africa, musical theatre

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Authors: Alok Bapatla, Pamela Lutting, Mariastella Serrano

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Background: Irritable Bowel Syndrome (IBS) is a functional gastrointestinal disorder characterized by abdominal pain associated with altered bowel habits in the absence of an underlying organic cause. Although the exact etiology of IBS is not fully understood, one of the leading theories postulates a pathology within the Brain-Gut Axis that leads to an overall increase in gastrointestinal sensitivity and pejorative changes in gastrointestinal motility. Research and clinical practice have shown that Gut Directed Hypnotherapy (GDH) has a beneficial clinical role in improving Mind-Gut control and thereby comorbid conditions such as anxiety, abdominal pain, constipation, and diarrhea. Aims: This study presents a 17-year old male with underlying anxiety and a one-year history of IBS-Constipation Predominant Subtype (IBS-C), who has demonstrated impressive improvement of symptoms following GDH treatment following refractory trials with medications including bisacodyl, senna, docusate, magnesium citrate, lubiprostone, linaclotide. Method: The patient was referred to a licensed clinical psychologist specializing in clinical hypnosis and cognitive-behavioral therapy (CBT), who implemented “The Standardized Hypnosis Protocol for IBS” developed by Dr. Olafur S. Palsson, Psy.D at the University of North Carolina at Chapel Hill. The hypnotherapy protocol consisted of a total of seven weekly 45-minute sessions supplemented with a 20-minute audio recording to be listened to once daily. Outcome variables included the GAD-7, PHQ-9 and DCI-2, as well as self-ratings (ranging 0-10) for pain (intensity and frequency), emotional distress about IBS symptoms, and overall emotional distress. All variables were measured at intake prior to administration of the hypnosis protocol and at the conclusion of the hypnosis treatment. A retrospective IBS Questionnaire (IBS Severity Scoring System) was also completed at the conclusion of the GDH treatment for pre-and post-test ratings of clinical symptoms. Results: The patient showed improvement in all outcome variables and self-ratings, including abdominal pain intensity, frequency of abdominal pain episodes, emotional distress relating to gut issues, depression, and anxiety. The IBS Questionnaire showed a significant improvement from a severity score of 400 (defined as severe) prior to GDH intervention compared to 55 (defined as complete resolution) at four months after the last session. IBS Questionnaire subset questions that showed a significant score improvement included abdominal pain intensity, days of pain experienced per 10 days, satisfaction with bowel habits, and overall interference of life affected by IBS symptoms. Conclusion: This case supports the existing research literature that GDH has a significantly beneficial role in improving symptoms in patients with IBS. Emphasis is placed on the numerical results of the IBS Questionnaire scoring, which reflects a patient who initially suffered from severe IBS with failed response to multiple medications, who subsequently showed full and sustained resolution

Keywords: pediatrics, constipation, irritable bowel syndrome, hypnotherapy, gut-directed hypnosis

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Authors: Neil Singla, Derek Muse, Karen DiDonato, Pamela Palmer

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Introduction: Pain is the most common reason people visit emergency rooms. Studies indicate however, that Emergency Department (ED) physicians often do not provide adequate analgesia to their patients as a result of gender and age bias, opiophobia and insufficient knowledge of and formal training in acute pain management. Novel classes of analgesics have recently been introduced, but many patients suffer from acute pain in settings where the availability of intravenous (IV) access may be limited, so there remains a clinical need for rapid-acting, potent analgesics that do not require an invasive route of delivery. A sublingual sufentanil tablet (SST), dispensed using a single-dose applicator, is in development for treatment of moderate-to-severe acute pain in a medically-supervised setting. Objective: The primary objective of this study was to demonstrate the repeat-dose efficacy, safety and tolerability of sufentanil 20 mcg and 30 mcg sublingual tablets compared to placebo for the management of acute pain as determined by the time-weighted sum of pain intensity differences (SPID) to baseline over the 12-hour study period (SPID12). Key secondary efficacy variables included SPID over the first hour (SPID1), Total pain relief over the 12-hour study period (TOTPAR12), time to perceived pain relief (PR) and time to meaningful PR. Safety variables consisted of adverse events (AE), vital signs, oxygen saturation and early termination. Methods: In this Phase 2, double-blind, dose-finding study, an equal number of male and female patients were randomly assigned in a 2:2:1 ratio to SST 20 mcg, SS 30 mcg or placebo, respectively, following bunionectomy. Study drug was dosed as needed, but not more frequently than hourly. Rescue medication was available as needed. The primary endpoint was the Summed Pain Intensity Difference to baseline over 12h (SPIDI2). Safety was assessed by continuous oxygen saturation monitoring and adverse event reporting. Results: 101 patients (51 Male/50 Female) were randomized, 100 received study treatment (intent-to-treat [ITT] population), and 91 completed the study. Reasons for early discontinuation were lack of efficacy (6), adverse events (2) and drug-dosing error (1). Mean age was 42.5 years. For the ITT population, SST 30 mcg was superior to placebo (p=0.003) for the SPID12. SPID12 scores in the active groups were superior for both male (ANOVA overall p-value =0.038) and female (ANOVA overall p-value=0.005) patients. Statistically significant differences in favour of sublingual sufentanil were also observed between the SST 30mcg and placebo group for SPID1(p<0.001), TOTPAR12(p=0.002), time to perceived PR (p=0.023) and time to meaningful PR (p=0.010). Nausea, vomiting and somnolence were more frequent in the sufentanil groups but there were no significant differences between treatment arms for the proportion of patients who prematurely terminated due to AE or inadequate analgesia. Conclusions: Sufentanil tablets dispensed sublingually using a single-dose applicator is in development for treatment of patients with moderate-to-severe acute pain in a medically-supervised setting where immediate IV access is limited. When administered sublingually, sufentanil’s pharmacokinetic profile and non-invasive delivery makes it a useful alternative to IM or IV dosing.

Keywords: acute pain, pain management, sublingual, sufentanil

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