Search results for: vaccine administration

Authors: Raj Chandran, Saul Datwyler, Jaime Marino, Daniel West, Karla Grasso, Adam Buss, Hina Syed, Zina Al Sahouri, Jennifer Yen, Krista Caudle, Beth McQuiston

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The Alinity i TBI test is Therapeutic Goods Administration (TGA) registered and is a panel of in vitro diagnostic chemiluminescent microparticle immunoassays for the measurement of glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase L1 (UCH-L1) in plasma and serum. The Alinity i TBI performance was evaluated in a multi-center pivotal study to demonstrate the capability to assist in determining the need for a CT scan of the head in adult subjects (age 18+) presenting with suspected mild TBI (traumatic brain injury) with a Glasgow Coma Scale score of 13 to 15. TBI has been recognized as an important cause of death and disability and is a growing public health problem. An estimated 69 million people globally experience a TBI annually1. Blood-based biomarkers such as glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase L1 (UCH-L1) have shown utility to predict acute traumatic intracranial injury on head CT scans after TBI. A pivotal study using prospectively collected archived (frozen) plasma specimens was conducted to establish the clinical performance of the TBI test on the Alinity i system. The specimens were originally collected in a prospective, multi-center clinical study. Testing of the specimens was performed at three clinical sites in the United States. Performance characteristics such as detection limits, imprecision, linearity, measuring interval, expected values, and interferences were established following Clinical and Laboratory Standards Institute (CLSI) guidance. Of the 1899 mild TBI subjects, 120 had positive head CT scan results; 116 of the 120 specimens had a positive TBI interpretation (Sensitivity 96.7%; 95% CI: 91.7%, 98.7%). Of the 1779 subjects with negative CT scan results, 713 had a negative TBI interpretation (Specificity 40.1%; 95% CI: 37.8, 42.4). The negative predictive value (NPV) of the test was 99.4% (713/717, 95% CI: 98.6%, 99.8%). The analytical measuring interval (AMI) extends from the limit of quantitation (LoQ) to the upper LoQ and is determined by the range that demonstrates acceptable performance for linearity, imprecision, and bias. The AMI is 6.1 to 42,000 pg/mL for GFAP and 26.3 to 25,000 pg/mL for UCH-L1. Overall, within-laboratory imprecision (20 day) ranged from 3.7 to 5.9% CV for GFAP and 3.0 to 6.0% CV for UCH-L1, when including lot and instrument variances. The Alinity i TBI clinical performance results demonstrated high sensitivity and high NPV, supporting the utility to assist in determining the need for a head CT scan in subjects presenting to the emergency department with suspected mild TBI. The GFAP and UCH-L1 assays show robust analytical performance across a broad concentration range of GFAP and UCH-L1 and may serve as a valuable tool to help evaluate TBI patients across the spectrum of mild to severe injury.

Keywords: biomarker, diagnostic, neurology, TBI

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Authors: Sharad Kumar Kulshreshtha

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India is a great land of cultural and traditional diversity. Its spectrums create a unique ambiance in all over the country. Specially, fairs and festivals are ancient phenomena in Indian culture. In India, there are thousands of such religious, spiritual, cultural fairs organized on auspicious occasions. These fairs reflect the effective and efficient role of social governance and responsibility of Indian society. In this context a mega event known as ‘Kumbha Mela’ literally mean ‘Kumbha Fair’ which is organize after every twelve years at (Prayaag) Allahabad an ancient city of India, now is in the state of Uttar Pradesh. Kumbh Mela is one of the largest human congregations on the Earth. The Kumbha Mela that is held here is considered to be the largest and holiest city among the four cities where Kubha fair organize. According to the Hindu religious scripture a dip for possessing the holy confluence, known as Triveni Sangam, which is a meeting point of the three sacred rivers of India i.e., –Ganges, Yamuna and Saraswati (mythical). During the Kumbha fair the River Ganges is believed to turn to nectar, bringing great blessing to everyone who bathes in it. Other activities include religious discussions, devotional singings and mass feedings pilgrims and poor. The venue for Kumbh Mela (fair) depends on the position Sun, Moon, and Jupiter which holds in that period in different zodiac signs. More than 120 Millions (12 Crore) people visited in the Kumbha Fair-2013 in Allahabad. A temporary tented city was set up for the pilgrims over an area of 2 hectares of the land along the river of Ganges. As many as 5 power substations, temporary police stations, hospitals, bus terminals, stalls were set up for providing various facilities to the visitors and thousands of volunteers participated for assistance of this event. All efforts made by fair administration to provide facility to visitors, such security and sanitation, medical care and frequent water and power supply. The efficient and timely arrangement at the Kumbha Mela attracted the attention of many government and institutions. The Harvard University of USA conducted research to find out how it was made possible. This paper will focuses on effective and efficient planning and preparation of Kumbha Fair which includes facilitation process, role of various coordinating agencies. risk management crisis management strategies Prevention, Preparedness, Response, and Recovery (PPRR Approach), emergency response plan (ERP), safety and security issues, various environmental aspects along with health hazards and hygiene crowd management, evacuation, monitoring, control and evaluation.

Keywords: event planning and facility arrangement, risk management, crowd management, India

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Authors: Ishan Naidu, Jessica Ryvlin, Devin Videlefsky

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Introduction: Back pain is a leading cause of years lived with disability and economic burden, exceeding over $20 billion in healthcare costs not including indirect costs such as absence from work and caregiving. The multifactorial nature of back pain leads to treatment modalities administered by a variety of specialists, which are often disjointed. Multiple studies have found that patients receiving delayed physical therapy for lower back pain had higher medical-related costs from increased health service utilization as well as a reduced improvement in pain severity compared to early management. Uncoordinated health care delivery can exacerbate the physical and economic toll of the chronic condition, thus improvements in interdisciplinary, shared decision-making may improve outcomes. Objective: To assess whether a multidisciplinary spine clinic (MSC), consisting of orthopedic surgery, neurosurgery, pain medicine, and physiatry, alters interventional and non-interventional planning and treatment compared to a traditional unidisciplinary spine clinic (USC) including only orthopedic surgery. Methods: We conducted a retrospective cohort study with patients initially presenting for spine care to orthopedic surgeons between July 1, 2018 to June 30, 2019. Time to treatment recommendation, time to treatment and rates of treatment recommendations were assessed, including physical therapy, injections and surgery. Treatment rates were compared between MSC and USC using Pearson’s chi-square test logistic regression. Time to treatment recommendation and time to treatment were compared using log-rank test and Cox proportional hazard regression. All analyses were repeated for the propensity score (PS) matched subsample. Results: This study included 1,764 patients, with 692 at MSC and 1,072 at USC. Patients in MSC were more likely to be recommended injection when compared to USC (8.5% vs. 5.4%, p=0.01). When adjusted for confounders, the likelihood of injection recommendation remained greater in MSC than USC (Odds ratio [OR]=2.22, 95% CI: (1.39, 3.53), p=0.001). MSC was also associated with a shorter time to receiving injection recommendation versus USC (median: 21 vs. 32 days, log-rank: p<0.001; hazard ratio [HR]=1.90, 95% CI: (1.25, 2.90), p=0.003). MSC was associated with a higher likelihood of injection treatment (OR=2.27, 95% CI: (1.39, 3.73), p=0.001) and shorter lead time (HR=1.98, 95% CI: (1.27, 3.09), p=0.003). PS-matched analyses yielded similar conclusions. Conclusions: Care delivered at a multidisciplinary spine clinic was associated with a higher likelihood of recommending injection and a shorter lead time to injection administration when compared to a traditional unidisciplinary spine surgery clinic. Multidisciplinary clinics may facilitate coordinated care amongst different specialties resulting in increased utilization of less invasive treatment modalities while also improving care efficiency. The multidisciplinary clinic model is an important advancement in care delivery and communication, which can be used as a powerful method of improving patient outcomes as treatment guidelines evolve.

Keywords: coordinated care, epidural steroid injection, multi-disciplinary, non-invasive

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Authors: Claudia P. Saunderson

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Widening of participation in higher education globally has increased diversity of student populations. However, widening participation is more than mere access. Central to the debate about widening participation are social justice issues of authentic inclusion and appropriate support for success for all students in higher education (HE). Given the recent global campaign for 'Black Lives Matter' as well as the worldwide advocacy for justice in the George Floyd case, the importance of the experiences of Black men, were again poignantly foregrounded. The literature abounds with the negative experiences of Black male students in higher education. Much of this literature emanates from the Global North, with little systematic research on black male students' university experiences originating from the Global South. This research, therefore, explores the psychosocial experiences of Black male students at a historically white South African university. Not only are these students' educational or academic adjustment important, but so is their psychosocial adjustment to the institution. The psychosocial adjustment might include emotional well-being, motivation, as well as the student’s perception of how well he fits in or is made to feel welcome at the institution. The study draws on strands of critical race theory (CRT), co-cultural theory (CCT) as well as defining properties of micro-aggression theory (MAT). In the study, CRT, therefore, served as an overarching theory at the macro level, and it comments on the structural dynamics while MAT and CCT rather focussed on the impact of structural arrangements like racialization, at an individual and micro-level. These theories furthermore provided a coherent analytic framework for this study. Using a case study design, this qualitative study, employing focus groups and individual interviews, drew on the psychosocial experiences of twenty Black male students to explore how they navigate this specific historically white campus. The data were analyzed using thematic analysis that provided a systematic procedure for generating codes and themes from the qualitative data. The study found that the combination of race and gender-based micro-aggressions experienced by students included negative stereotyping, criminalization as well as racial profiling and that these experiences impede participants' ability to thrive at the institution. However, participants also shared positive perspectives about the institution. Some of the positive traits of the institution that the participants mentioned were well-aligned administration, good quality of education, as well as various funding opportunities. This study implies that if any HE institution values transformation, it necessitates the exploration and interrogation of potential aspects that are subtly hidden in the institutional culture and environment that might serve as barriers to the transformation process. This positioning is based on a social justice stance and believes that all students are equal and have the right to racially and culturally equitable and appropriate education and support.

Keywords: critical race theory, higher education transformation, micro-aggression, student experience

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Authors: Nikitha Francis, Anjana Hoode, Vinitha George, Jayashree S. Bhat

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The interaction between cognition and language, referred as cognitive-communication, is very intricate, involving several mental processes such as perception, memory, attention, lexical retrieval, decision making, motor planning, self-monitoring and knowledge. Cognitive-communication disorders are difficulties in communicative competencies that result from underlying cognitive impairments of attention, memory, organization, information processing, problem solving, and executive functions. Traumatic brain injury (TBI) is an acquired, non - progressive condition, resulting in distinct deficits of cognitive communication abilities such as naming, word-finding, self-monitoring, auditory recognition, attention, perception and memory. Cognitive-communication intervention in TBI is individualized, in order to enhance the person’s ability to process and interpret information for better functioning in their family and community life. The present case report illustrates the cognitive-communicative behaviors and the intervention outcomes of an adult with TBI, who was brought to the Department of Audiology and Speech Language Pathology, with cognitive and communicative disturbances, consequent to road traffic accident. On a detailed assessment, she showed naming deficits along with perseverations and had severe difficulty in recalling the details of the accident, her house address, places she had visited earlier, names of people known to her, as well as the activities she did each day, leading to severe breakdowns in her communicative abilities. She had difficulty in initiating, maintaining and following a conversation. She also lacked orientation to time and place. On administration of the Manipal Manual of Cognitive Linguistic Abilities (MMCLA), she exhibited poor performance on tasks related to visual and auditory perception, short term memory, working memory and executive functions. She attended 20 sessions of cognitive-communication intervention which followed a domain-general, adaptive training paradigm, with tasks relevant to everyday cognitive-communication skills. Compensatory strategies such as maintaining a dairy with reminders of her daily routine, names of people, date, time and place was also recommended. MMCLA was re-administered and her performance in the tasks showed significant improvements. Occurrence of perseverations and word retrieval difficulties reduced. She developed interests to initiate her day-to-day activities at home independently, as well as involve herself in conversations with her family members. Though she lacked awareness about her deficits, she actively involved herself in all the therapy activities. Rehabilitation of moderate to severe head injury patients can be done effectively through a holistic cognitive retraining with a focus on different cognitive-linguistic domains. Selection of goals and activities should have relevance to the functional needs of each individual with TBI, as highlighted in the present case report.

Keywords: cognitive-communication, executive functions, memory, traumatic brain injury

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Authors: Alvarez M., Chapela M. J., Balboa E., Rubianes D., Sinde E., Fernandez de Ana C., Rodríguez-Blanco A.

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The gut microbiota plays an important role as gut inflammation could contribute to colorectal cancer development; however, this role is still not fully understood, and tools able to prevent this progression are yet to be developed. The main objective of this study was to monitor the effects of a mushroom extracts formulation in gut microbial community composition of an Azoxymethane (AOM)/Dextran sodium sulfate (DSS) mice model of inflammation-linked carcinogenesis. For the in vivo study, 41 adult male mice of the C57BL / 6 strain were obtained. 36 of them have been induced in a state of colon carcinogenesis by a single intraperitoneal administration of AOM at a dose of 12.5 mg/kg; the control group animals received instead of the same volume of 0.9% saline. DSS is an extremely toxic polysaccharide sulfate that causes chronic inflammation of the colon mucosa, favoring the appearance of severe colitis and the production of tumors induced by AOM. Induction by AOM/DSS is an interesting platform for chemopreventive intervention studies. This time the model was used to monitor gut microbiota changes as a result of supplementation with a specific mushroom extracts formulation previously shown to have prebiotic activity. The animals have been divided into three groups: (i) Cancer + mushroom extracts formulation experimental group: to which the MicoDigest2.0 mushroom extracts formulation developed by Hifas da Terra S.L has been administered dissolved in drinking water at an estimated concentration of 100 mg / ml. (ii) Control group of animals with Cancer: to which normal water has been administered without any type of treatment. (iii) Control group of healthy animals: these are the animals that have not been induced cancer or have not received any treatment in drinking water. This treatment has been maintained for a period of 3 months, after which the animals were sacrificed to obtain tissues that were subsequently analyzed to verify the effects of the mushroom extract formulation. A microbiological analysis has been carried out to compare the microbial communities present in the intestines of the mice belonging to each of the study groups. For this, the methodology of massive sequencing by molecular analysis of the 16S gene has been used (Ion Torrent technology). Initially, DNA extraction and metagenomics libraries were prepared using the 16S Metagenomics kit, always following the manufacturer's instructions. This kit amplifies 7 of the 9 hypervariable regions of the 16S gene that will then be sequenced. Finally, the data obtained will be compared with a database that makes it possible to determine the degree of similarity of the sequences obtained with a wide range of bacterial genomes. Results obtained showed that, similarly to certain natural compounds preventing colorectal tumorigenesis, a mushroom formulation enriched the Firmicutes and Proteobacteria phyla and depleted Bacteroidetes. Therefore, it was demonstrated that the consumption of the mushroom extracts’ formulation developed could promote the recovery of the microbial balance that is disrupted in the mice model of carcinogenesis. More preclinical and clinical studies are needed to validate this promising approach.

Keywords: carcinogenesis, microbiota, mushroom extracts, inflammation

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Authors: Mbonigaba Swale

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Malaria is an infection or disease caused by parasites (Plasmodium Falciparum — causes severe Malaria, plasmodium Vivax, Plasmodium Ovale, and Plasmodium Malariae), transmitted by bites of infected anopheles (female) mosquitoes to humans. These vectors comprise of two types in Africa, particularly in Uganda, i.e. anopheles fenestus and Anopheles gambaie (‘example Anopheles arabiensis,,); feeds on man inside the house mainly at dusk, mid-night and dawn and rests indoors and makes them effective transmitters (vectors) of the disease. People in both urban and rural areas have consistently become prone to repetitive attacks of malaria, causing a lot of deaths and significantly increasing the poverty levels of the rural poor. Malaria is a national problem; it causes a lot of maternal pre-natal and antenatal disorders, anemia in pregnant mothers, low birth weights for the newly born, convulsions and epilepsy among the infants. Cumulatively, it kills about one million children every year in sub-Saharan Africa. It has been estimated to account for 25-35% of all outpatient visits, 20-45% of acute hospital admissions and 15-35% of hospital deaths. Uganda is the leading victim country, for which Rakai and Masaka districts are the most affected. So, it is not clear whether these abhorrent situations and episodes of recurrences and failure to cure from the disease are a result of poor diagnosis, prescription and dosing, treatment habits and compliance of the patients to the drugs or the ethical domain of the stake holders in relation to the main stream methodology of malaria management. The research is aimed at offering an alternative approach to manage and deal absolutely with problem by using a knowledge based software model of Artificial Intelligence (Al) that is capable of performing common-sense and cognitive reasoning so as to take decisions like the human brain would do to provide instantaneous expert solutions so as to avoid speculative simulation of the problem during differential diagnosis in the most accurate and literal inferential aspect. This system will assist physicians in many kinds of medical diagnosis, prescribing treatments and doses, and in monitoring patient responses, basing on the body weight and age group of the patient, it will be able to provide instantaneous and timely information options, alternative ways and approaches to influence decision making during case analysis. The computerized system approach, a new model in Uganda termed as “Software Aided Treatment” (SAT) will try to change the moral and ethical approach and influence conduct so as to improve the skills, experience and values (social and ethical) in the administration and management of the disease and drugs (combination therapy and generics) by both the patient and the health worker.

Keywords: knowledge based software, management, treatment, diagnosis

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Authors: Robert Rorie, Lisa Fern

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The integration of Unmanned Aircraft Systems (UAS) into the National Airspace System (NAS) poses a variety of technical challenges to UAS developers and aviation regulators. In response to growing demand for access to civil airspace in the United States, the Federal Aviation Administration (FAA) has produced a roadmap identifying key areas requiring further research and development. One such technical challenge is the development of a ‘detect and avoid’ system (DAA; previously referred to as ‘sense and avoid’) to replace the ‘see and avoid’ requirement in manned aviation. The purpose of the DAA system is to support the pilot, situated at a ground control station (GCS) rather than in the cockpit of the aircraft, in maintaining ‘well clear’ of nearby aircraft through the use of GCS displays and alerts. In addition to its primary function of aiding the pilot in maintaining well clear, the DAA system must also safely interoperate with existing NAS systems and operations, such as the airspace management procedures of air traffic controllers (ATC) and collision avoidance (CA) systems currently in use by manned aircraft, namely the Traffic alert and Collision Avoidance System (TCAS) II. It is anticipated that many UAS architectures will integrate both a DAA system and a TCAS II. It is therefore necessary to explicitly study the integration of DAA and TCAS II alerting structures and maneuver guidance formats to ensure that pilots understand the appropriate type and urgency of their response to the various alerts. This paper presents a concept of interoperability for the two systems. The concept was developed with the goal of avoiding any negative impact on the performance level of TCAS II (understanding that TCAS II must largely be left as-is) while retaining a DAA system that still effectively enables pilots to maintain well clear, and, as a result, successfully reduces the frequency of collision hazards. The interoperability concept described in the paper focuses primarily on facilitating the transition from a late-stage DAA encounter (where a loss of well clear is imminent) to a TCAS II corrective Resolution Advisory (RA), which requires pilot compliance with the directive RA guidance (e.g., climb, descend) within five seconds of its issuance. The interoperability concept was presented to 10 participants (6 active UAS pilots and 4 active commercial pilots) in a medium-fidelity, human-in-the-loop simulation designed to stress different aspects of the DAA and TCAS II systems. Pilot response times, compliance rates and subjective assessments were recorded. Results indicated that pilots exhibited comprehension of, and appropriate prioritization within, the DAA-TCAS II combined alert structure. Pilots demonstrated a high rate of compliance with TCAS II RAs and were also seen to respond to corrective RAs within the five second requirement established for manned aircraft. The DAA system presented under test was also shown to be effective in supporting pilots’ ability to maintain well clear in the overwhelming majority of cases in which pilots had sufficient time to respond. The paper ends with a discussion of next steps for research on integrating UAS into civil airspace.

Keywords: detect and avoid, interoperability, traffic alert and collision avoidance system (TCAS II), unmanned aircraft systems

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Authors: Azza A. Ali, Mona G. Khalil, Hemat A. Elariny, Shereen S. El Shaer

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Background: Aluminium (Al) is very abundant metal in the earth’s crust. It is a constituent of cooking utensils, medicines, cosmetics, some foods and food additives. Salts of Al are widely used in the treatment of drinking water for purification purposes. Excessive and prolonged exposure to Al causes oxidative stress and impairment of many physiological functions. Its accumulation in liver and kidney causes hepatotoxicity and nephrotoxicity. Social isolation (SI) or Protein malnutrition (PM) also increases oxidative stress and may enhance the toxicity of Al as well as the degeneration in liver and kidney. Epigallocatechin-3-gallate (EGCG) is the most abundant catechin in green tea and has strong antioxidant as well as anti-inflammatory activities and can protect against oxidative stress-induced degenerations. Objective: To study the influence of stress or PM on Al-induced nephrotoxicity and hepatotoxicity in rats, as well as on the potential role of EGCG in providing protection. Methods: Rats received daily AlCl3 (70 mg/kg, IP) for three weeks (Al-toxicity groups) except one normal control group received saline. Al-toxicity groups were divided into four treated and four untreated groups; treated rats received EGCG (10 mg/kg, IP) together with AlCl3. One group of both treated and untreated rats served as control for each of them, and the others were subjected to either stress (mild using isolation or high using electric shock) or to PM (10% casein diet). Specimens of liver and kidney were used for assessment of levels of inflammatory mediators as TNF-α, IL6β, nuclear factor kappa B (NF-κB), oxidative stress (MDA, SOD, TAC, NO), Caspase-3 and for DNA fragmentation as well as for histopathological examinations. Biochemical changes were also measured in the serum as total lipids, cholesterol, triglycerides, glucose, proteins, bilirubin, creatinine and urea as well as the level of Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) and lactate deshydrogenase (LDH). Results: Nephrotoxicity and hepatotoxicity induced by Al were enhanced in rats exposed to stress and to PM. The influence of stress was more pronounced than PM. Al-toxicity was indicated by the increase in liver and kidney MDA, NO, TNF-α, IL-6β, NF-κB, caspase-3, DNA fragmentation and in ALT, AST, ALP, LDH and total lipids, cholesterol, triglycerides, glucose, proteins, bilirubin, creatinine and urea levels, together with the decrease in total proteins, SOD, TAC. EGCG provided protection against hazards of Al as indicated by the decrease in MDA, NO, TNF-α, IL-6β, NF-κB, caspase-3 and DNA fragmentation as well as in levels of ALT, AST, ALP, LDH and total lipids, cholesterol, triglycerides, glucose, proteins, bilirubin, creatinine and urea in liver and kidney, together with the increase in total proteins, SOD, TAC and confirmed by histopathological examinations. It provided more pronounced protection in high stressful conditions than in mild one than in PM. Conclusion: Stress have a bad impact on Al-induced nephrotoxicity and hepatotoxicity more than PM. Thus it can clarify and maximize the role of EGCG in providing protection. Consequently, administration of EGCG is advised with excessive Al-exposure to avoid nephrotoxicity and hepatotoxicity especially in populations more subjected to stress or PM.

Keywords: aluminum, stress, protein malnutrition, nephrotoxicity, hepatotoxicity, epigallocatechin-3-gallate, rats

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Authors: Lucia Liu, Matthew Koziol

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Obsessive-compulsive disorder (OCD), a long-lasting anxiety disorder involving recurrent, intrusive thoughts, affects over 2 million adults in the United States. Transcranial magnetic stimulation (TMS) stands out as a noninvasive, cutting-edge therapy that has been shown to reduce symptoms in patients with treatment-resistant OCD. The Food and Drug Administration (FDA) approved protocol pairs TMS sessions with individualized symptom provocation, aiming to improve the susceptibility of brain circuits to stimulation. However, limited standardization or guidance exists on how to conduct symptom provocation and which methods are most effective. This study aims to compare the effect of internal versus external techniques to induce obsessional stress in a clinical setting during TMS therapy. Two symptom provocation methods, (i) Asking patients thought-provoking questions about their obsessions (internal) and (ii) Requesting patients to perform obsession-related tasks (external), were employed in a crossover design with repeated measurement. Thirty-six treatments of NeuroStar TMS were administered to each of two patients over 8 weeks in an outpatient clinic. Patient One received 18 sessions of internal provocation followed by 18 sessions of external provocation, while Patient Two received 18 sessions of external provocation followed by 18 sessions of internal provocation. The primary outcome was the level of self-reported obsessional stress on a visual analog scale from 1 to 10. The secondary outcome was self-reported OCD severity, collected biweekly in a four-level Likert-scale (1 to 4) of bad, fair, good and excellent. Outcomes were compared and tested between provocation arms through repeated measures ANOVA, accounting for intra-patient correlations. Ages were 42 for Patient One (male, White) and 57 for Patient Two (male, White). Both patients had similar moderate symptoms at baseline, as determined through the Yale-Brown Obsessive Compulsive Scale (YBOCS). When comparing obsessional stress induced across the two arms of internal and external provocation methods, the mean (SD) was 6.03 (1.18) for internal and 4.01 (1.28) for external strategies (P=0.0019); ranges were 3 to 8 for internal and 2 to 8 for external strategies. Internal provocation yielded 5 (31.25%) bad, 6 (33.33%) fair, 3 (18.75%) good, and 2 (12.5%) excellent responses for OCD status, while external provocation yielded 5 (31.25%) bad, 9 (56.25%) fair, 1 (6.25%) good, and 1 (6.25%) excellent responses (P=0.58). Internal symptom provocation tactics had a significantly stronger impact on inducing obsessional stress and led to better OCD status (non-significant). This could be attributed to the fact that answering questions may prompt patients to reflect more on their lived experiences and struggles with OCD. In the future, clinical trials with larger sample sizes are warranted to validate this finding. Results support the increased integration of internal methods into structured provocation protocols, potentially reducing the time required for provocation and achieving greater treatment response to TMS.

Keywords: obsessive-compulsive disorder, transcranial magnetic stimulation, mental health, symptom provocation

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Authors: Nicole Selvi Hill, Archchana Radhakrishnan

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Introduction: Traumatic brain injury (TBI) is a leading cause of mortality among trauma patients. In the management of TBI, the main principle is avoiding cerebral ischemia, as this is a strong determiner of neurological outcomes. The use of vasoactive drugs, such as vasopressin, has an important role in maintaining cerebral perfusion pressure to prevent secondary brain injury. Current guidelines do not suggest a preferred vasoactive drug to administer in the management of TBI, and there is a paucity of information on the therapeutic potential of vasopressin following TBI. Vasopressin is also an endogenous anti-diuretic hormone (AVP), and pathways mediated by AVP play a large role in the underlying pathological processes of TBI. This creates an overlap of discussion regarding the therapeutic potential of vasopressin following TBI. Currently, its popularity lies in vasodilatory and cardiogenic shock in the intensive care setting, with increasing support for its use in haemorrhagic and septic shock. Methodology: This is a review article based on a literature review. An electronic search was conducted via PubMed, Cochrane, EMBASE, and Google Scholar. The aim was to identify clinical studies looking at the therapeutic administration of vasopressin in severe traumatic brain injury. The primary aim was to look at the neurological outcome of patients. The secondary aim was to look at surrogate markers of cerebral perfusion measurements, such as cerebral perfusion pressure, cerebral oxygenation, and cerebral blood flow. Results: Eight papers were included in the final number. Three were animal studies; five were human studies, comprised of three case reports, one retrospective review of data, and one randomised control trial. All animal studies demonstrated the benefits of vasopressors in TBI management. One animal study showed the superiority of vasopressin in reducing intracranial pressure and increasing cerebral oxygenation over a catecholaminergic vasopressor, phenylephrine. All three human case reports were supportive of vasopressin as a rescue therapy in catecholaminergic-resistant hypotension. The retrospective review found vasopressin did not increase cerebral oedema in TBI patients compared to catecholaminergic vasopressors; and demonstrated a significant reduction in the requirements of hyperosmolar therapy in patients that received vasopressin. The randomised control trial results showed no significant differences in primary and secondary outcomes between TBI patients receiving vasopressin versus those receiving catecholaminergic vasopressors. Apart from the randomised control trial, the studies included are of low-level evidence. Conclusion: Studies favour vasopressin within certain parameters of cerebral function compared to control groups. However, the neurological outcomes of patient groups are not known, and animal study results are difficult to extrapolate to humans. It cannot be said with certainty whether vasopressin’s benefits stand above usage of other vasoactive drugs due to the weaknesses of the evidence. Further randomised control trials, which are larger, standardised, and rigorous, are required to improve knowledge in this field.

Keywords: catecholamines, cerebral perfusion pressure, traumatic brain injury, vasopressin, vasopressors

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Authors: Mathula Thangarajh

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Duchenne muscular dystrophy (DMD) is a severe form of X-linked muscular dystrophy caused by mutations in the dystrophin gene resulting in progressive skeletal muscle weakness. Boys with DMD also have significant cognitive disabilities. The intelligence quotient of boys with DMD, compared to peers, is approximately one standard deviation below average. Detailed neuropsychological testing has demonstrated that boys with DMD have a global developmental impairment, with verbal memory and visuospatial skills most significantly affected. Furthermore, the total brain volume and gray matter volume are lower in children with DMD compared to age-matched controls. These results are suggestive of a significant structural and functional compromise to the developing brain as a result of absent dystrophin protein expression. There is also some genetic evidence to suggest that mutations in the 3’ end of the DMD gene are associated with more severe neurocognitive problems. Our working hypothesis is that (i) boys with DMD do not make gains in neurodevelopmental skills compared to typically developing children and (ii) women carriers of DMD mutations may have subclinical cognitive deficits. We also hypothesize that there may be an intergenerational vulnerability of cognition, with boys of DMD-carrier mothers being more affected cognitively than boys of non-DMD-carrier mothers. The objectives of this study are: 1. Assess the neurodevelopment in boys with DMD at 4-time points and perform baseline neuroradiological assessment, 2. Assess cognition in biological mothers of DMD participants at baseline, 3. Assess possible correlation between DMD mutation and cognitive measures. This study also explores functional brain abnormalities in people with DMD by exploring how regional and global connectivity of the brain underlies executive function deficits in DMD. Such research can contribute to a better holistic understanding of the cognition alterations due to DMD and could potentially allow clinicians to create better-tailored treatment plans for the DMD population. There are four study visits for each participant (baseline, 2-4 weeks, 1 year, 18 months). At each visit, the participant completes the NIH Toolbox Cognition Battery, a validated psychometric measure that is recommended by NIH Common Data Elements for use in DMD. Visits 1, 3, and 4 also involve the administration of the BRIEF-2, ABAS-3, PROMIS/NeuroQoL, PedsQL Neuromuscular module 3.0, Draw a Clock Test, and an optional fMRI scan with the N-back matching task. We expect to enroll 52 children with DMD, 52 mothers of children with DMD, and 30 healthy control boys. This study began in 2020 during the height of the COVID-19 pandemic. Due to this, there were subsequent delays in recruitment because of travel restrictions. However, we have persevered and continued to recruit new participants for the study. We partnered with the Muscular Dystrophy Association (MDA) and helped advertise the study to interested families. Since then, we have had families from across the country contact us about their interest in the study. We plan to continue to enroll a diverse population of DMD participants to contribute toward a better understanding of Duchenne Muscular Dystrophy.

Keywords: neurology, Duchenne muscular dystrophy, muscular dystrophy, cognition, neurodevelopment, x-linked disorder, DMD, DMD gene

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Authors: Gabriela Wyszogrodzka, Przemyslaw Dorozynski, Barbara Gil, Maciej Strzempek, Bartosz Marszalek, Piotr Kulinowski, Wladyslaw Piotr Weglarz, Elzbieta Menaszek

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MOFs (Metal-Organic Frameworks) belong to a new group of porous materials with a hybrid organic-inorganic construction. Their structure is a network consisting of metal cations or clusters (acting as metallic centers, nodes) and the organic linkers between nodes. The interest in MOFs is primarily associated with the use of their well-developed surface and large porous. Possibility to build MOFs of biocompatible components let to use them as potential drug carriers. Furthermore, forming MOFs structure from cations possessing paramagnetic properties (e.g. iron cations) allows to use them as MRI (Magnetic Resonance Imaging) contrast agents. The concept of formation of particles that combine the ability to transfer active substance with imaging properties has been called theranostic (from words combination therapy and diagnostics). By building MOF structure from iron cations it is possible to use them as theranostic agents and monitoring the distribution of the active substance after administration in real time. In the study iron-MOF: Fe-MIL-101-NH2 was chosen, consisting of iron cluster in nodes of the structure and amino-terephthalic acid as a linker. The aim of the study was to investigate the possibility of applying Fe-MIL-101-NH2 as inhalable theranostic particulate system for the first-line anti-tuberculosis antibiotic – isoniazid. The drug content incorporated into Fe-MIL-101-NH2 was evaluated by dissolution study using spectrophotometric method. Results showed isoniazid encapsulation efficiency – ca. 12.5% wt. Possibility of Fe-MIL-101-NH2 application as the MRI contrast agent was demonstrated by magnetic resonance tomography. FeMIL-101-NH2 effectively shortening T1 and T2 relaxation times (increasing R1 and R2 relaxation rates) linearly with the concentrations of suspended material. Images obtained using multi-echo magnetic resonance imaging sequence revealed possibility to use FeMIL-101-NH2 as positive and negative contrasts depending on applied repetition time. MOFs micronization via ultrasound was evaluated by XRD, nitrogen adsorption, FTIR, SEM imaging and did not influence their crystal shape and size. Ultrasonication let to break the aggregates and achieve very homogeneously looking SEM images. MOFs cytotoxicity was evaluated in in vitro test with a highly sensitive resazurin based reagent PrestoBlue™ on L929 fibroblast cell line. After 24h no inhibition of cell proliferation was observed. All results proved potential possibility of application of ironMOFs as an isoniazid carrier and as MRI contrast agent in inhalatory treatment of tuberculosis. Acknowledgments: Authors gratefully acknowledge the National Science Center Poland for providing financial support, grant no 2014/15/B/ST5/04498.

Keywords: imaging agents, metal-organic frameworks, theranostics, tuberculosis

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Authors: Tatiana G. Smirnova, Stan G. Benjamin

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Rapid Update Cycle (RUC) land surface model (LSM) was a land-surface component in several generations of operational weather prediction models at the National Center for Environment Prediction (NCEP) at the National Oceanic and Atmospheric Administration (NOAA). It was designed for short-range weather predictions with an emphasis on severe weather and originally was intentionally simple to avoid uncertainties from poorly known parameters. Nevertheless, the RUC LSM, when coupled with the hourly-assimilating atmospheric model, can produce a realistic evolution of time-varying soil moisture and temperature, as well as the evolution of snow cover on the ground surface. This result is possible only if the soil/vegetation/snow component of the coupled weather prediction model has sufficient skill to avoid long-term drift. RUC LSM was first implemented in the operational NCEP Rapid Update Cycle (RUC) weather model in 1998 and later in the Weather Research Forecasting Model (WRF)-based Rapid Refresh (RAP) and High-resolution Rapid Refresh (HRRR). Being available to the international WRF community, it was implemented in operational weather models in Austria, New Zealand, and Switzerland. Based on the feedback from the US weather service offices and the international WRF community and also based on our own validation, RUC LSM has matured over the years. Also, a sea-ice module was added to RUC LSM for surface predictions over the Arctic sea-ice. Other modifications include refinements to the snow model and a more accurate specification of albedo, roughness length, and other surface properties. At present, RUC LSM is being tested in the regional application of the Unified Forecast System (UFS). The next generation UFS-based regional Rapid Refresh FV3 Standalone (RRFS) model will replace operational RAP and HRRR at NCEP. Over time, RUC LSM participated in several international model intercomparison projects to verify its skill using observed atmospheric forcing. The ESM-SnowMIP was the last of these experiments focused on the verification of snow models for open and forested regions. The simulations were performed for ten sites located in different climatic zones of the world forced with observed atmospheric conditions. While most of the 26 participating models have more sophisticated snow parameterizations than in RUC, RUC LSM got a high ranking in simulations of both snow water equivalent and surface temperature. However, ESM-SnowMIP experiment also revealed some issues in the RUC snow model, which will be addressed in this paper. One of them is the treatment of grid cells partially covered with snow. RUC snow module computes energy and moisture budgets of snow-covered and snow-free areas separately by aggregating the solutions at the end of each time step. Such treatment elevates the importance of computing in the model snow cover fraction. Improvements to the original simplistic threshold-based approach have been implemented and tested both offline and in the coupled weather model. The detailed description of changes to the snow cover fraction and other modifications to RUC soil and snow parameterizations will be described in this paper.

Keywords: land-surface models, weather prediction, hydrology, boundary-layer processes

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Authors: Hanan M. Hassan, Laila Abouzeid, Lamya H. Al-Wahaibi, George S. G. Shehatou, Ali A. El-Emam

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Cancer is a major public health problem and the second leading cause of death worldwide. In 2020, cancer diagnosis and treatment have been negatively affected by the coronavirus 2019 (COVID-19) pandemic. During the quarantine, because of the limited access to healthcare and avoiding exposure to COVID-19 as a contagious disease; patients of cancer suffered deferments in follow-up and treatment regimens leading to substantial worsening of disease, death, and increased healthcare costs. Thus, this study is designed to investigate the molecular mechanisms by which adamantne derivatives attenuate hepatocllular carcinoma experimentally and theoretically. There is a close association between increased resistance to anticancer drugs and defective apoptosis that considered a causative factor for oncogenesis. Cancer cells use different molecular pathways to inhibit apoptosis, BAX and Bcl-2 proteins have essential roles in the progression or inhibition of intrinsic apoptotic pathways triggered by mitochondrial dysfunction. Therefore, their balance ratio can promote the cellular apoptotic fate. In this study, the in vitro cytotoxic effects of seven synthetic adamantyl isothiorea derivatives were evaluated against five human tumor cell lines by MTT assay. Compounds 5 and 6 showed the best results, mostly against hepatocellular carcinoma (HCC). Hence, in vivo studies were performed in male Sprague-Dawley (SD) rats in which experimental hepatocellular carcinoma was induced with thioacetamide (TAA) (200 mg/kg, i.p., twice weekly) for 16 weeks. The most promising compounds, 5 and 6, were administered to treat liver cancer rats at a dose of 10 mg/kg/day for an additional two weeks, and the effects were compared with doxorubicin (DR), the anticancer drug. Hepatocellular carcinoma was evidenced by a dramatic increase in liver indices, oxidative stress markers, and immunohistochemical studies that were accompanied by a plethora of inflammatory mediators and alterations in the apoptotic cascade. Our results showed that treatment with adamantane derivatives 5 and 6 significantly suppressed fibrosis, inflammation, and other histopathological insults resulting in the diminished formation of hepatocyte tumorigenesis. Moreover, administration of the tested compounds resulted in amelioration of EGFR protein expression, upregulation of BAX, and lessening down of Bcl-2 levels that prove their role as apoptosis inducers. Also, the docking simulations performed for adamantane showed good fit and binding to the EGFR protein through hydrogen bond formation with conservative amino acids, which gives a shred of strong evidence for its hepatoprotective effect. In most analyses, the effects of compound 6 were more comparable to DR than compound 5. Our findings suggest that adamantane derivatives 5 and 6 are shown to have cytotoxic activity against HCC in vitro and in vivo, by more than one mechanism, possibly by inhibiting the TLR4-MyD88-NF-κB pathway and targeting EGFR signaling.

Keywords: adamantane, EGFR, HCC, apoptosis

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Authors: Yen-Hui Lu

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In the past two decades, in order to increase university visibility and internationalization, English as a medium of instruction (EMI) has become one of the main language policies in higher education institutions where English is not a dominant language. However, given the complex, discipline-embedded nature of academic communication, academic literacy does not come with students’ everyday language experience, and it is a challenge for all students. Particularly, to engage students in the effective learning process of discipline concepts in the EMI classrooms, teachers need to provide explicit academic language instruction to assist students in deep understanding of discipline concepts. To bridge the gap between academic language development and discipline learning in the EMI classrooms, the researcher incorporates academic language strategies and key elements of project-based learning (PBL) into an Academic Language Strategy driven PBL (ALS-PBL) model. With clear steps and strategies, the model helps EMI teachers to scaffold students’ academic language development in the EMI classrooms. ALS-PBL model includes three major stages: preparation, implementation, and assessment. First, in the preparation stage, ALS-PBL teachers need to identify learning goals for both content and language learning and to design PBL topics for investigation. Second, during the implementation stage, ALS-PBL teachers use the model as a guideline to create a lesson structure and class routine. There are five important elements in the implementation stage: (1) academic language preparation, (2) connecting background knowledge, (3) comprehensible input, (4) academic language reinforcement, and (5) sustained inquiry and project presentation. Finally, ALS-PBL teachers use formative assessments such as student learning logs, teachers’ feedback, and peer evaluation to collect detailed information that demonstrates students’ academic language development in the learning process. In this study, ALS-PBL model was implemented in an interdisciplinary course entitled “Science is Everywhere”, which was co-taught by five professors from different discipline backgrounds, English education, civil engineering, business administration, international business, and chemical engineering. The purpose of the course was to cultivate students’ interdisciplinary knowledge as well as English competency in disciplinary areas. This study used a case-study design to systematically investigate students’ learning experiences in the class using ALS-PBL model. The participants of the study were 22 college students with different majors. This course was one of the elective EMI courses in this focal university. The students enrolled in this EMI course to fulfill the school language policy, which requires the students to complete two EMI courses before their graduation. For the credibility, this study used multiple methods to collect data, including classroom observation, teachers’ feedback, peer assessment, student learning log, and student focus-group interviews. Research findings show four major successful aspects of implementing ALS-PBL model in the EMI classroom: (1) clear focus on both content and language learning, (2) meaningful practice in authentic communication, (3) reflective learning in academic language strategies, and (4) collaborative support in content knowledge.This study will be of value to teachers involved in delivering English as well as content lessons to language learners by providing a theoretically-sound practical model for application in the classroom.

Keywords: academic language development, content and language integrated learning, english as a medium of instruction, project-based learning

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Authors: Jaci Marie Mastrandrea, Rosario Haro

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Background: The National Comprehensive Cancer Network (NCCN) recommends that healthcare institutions have established processes for integrating palliative care (PC) into cancer treatment and that all cancer patients be screened for PC needs upon initial diagnosis as well as throughout the entire continuum of care (National Comprehensive Cancer Network, 2021). Early PC screening and intervention is directly associated with improved patient outcomes. The Sky Lakes Cancer Treatment Center (SLCTC) is an institution that has access to PC services yet does not have protocols in place for identifying patients with palliative needs or a standardized referral process. The aim of this quality improvement project was to improve early access to PC services by establishing a standardized screening and referral process for outpatient oncology patients. Method: The sample population included all adult patients with an oncology diagnosis who presented to the SLCTC for treatment during the project timeline. The “Palliative and Supportive Needs Assessment'' (PSNA) screening tool was developed from validated, evidence-based PC referral criteria. The tool was initially implemented using paper forms, and data was collected over a period of eight weeks. Patients were screened by nurses on the SLCTC oncology treatment team. Nurses responsible for screening patients received an educational inservice prior to implementation. Patients with a PSNA score of three or higher received an educational handout on the topic of PC and education about PC and symptom management. A score of five or higher indicates that PC referral is strongly recommended, and the patient’s EHR is flagged for the oncology provider to review orders for PC referral. The PSNA tool was approved by Sky Lakes administration for full integration into Epic-Beacon. The project lead collaborated with the Sky Lakes’ information systems team and representatives from Epic on the tool’s aesthetic and functionality within the Epic system. SLCTC nurses and physicians were educated on how to document the PSNA within Epic and where to view results. Results: Prior to the implementation of the PSNA screening tool, the SLCTC had zero referrals to PC in the past year, excluding referrals to hospice. Data was collected from the completed screening assessments of 100 patients under active treatment at the SLCTC. Seventy-three percent of patients met criteria for PC referral with a score greater than or equal to three. Of those patients who met referral criteria, 53.4% (39 patients) were referred for a palliative and supportive care consultation. Patients that were not referred to PC upon meeting criteria were flagged in EPIC for re-screening within one to three months. Patients with lung cancer, chronic hematologic malignancies, breast cancer, and gastrointestinal malignancy most frequently met the criteria for PC referral and scored highest overall on the scale of 0-12. Conclusion: The implementation of a standardized PC screening tool at the SLCTC significantly increased awareness of PC needs among cancer patients in the outpatient setting. Additionally, data derived from this quality improvement project supports the national recommendation for PC to be an integral component of cancer treatment across the entire continuum of care.

Keywords: oncology, palliative and supportive care, symptom management, outpatient oncology, palliative screening tool

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Authors: Ogunmefun Folorunsho Muyideen, Aluko Tolulope Evelyn

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One of the trending menaces faced in the world today is centered on the porosity of borders and proliferation of illegal weapons among the state members without the state authorizations. The proliferation of weapons along porous borders remains a germane and unsolvable question among developed and developing nations due to crisis degenerated from the menace (loss of lives, properties, traumatization, civil unrest and retrogressive economic development). A mixed method was adopted while the survey method was used for communities’ selection (Oke-Odan, Ajilete, Illaise, Lanlate) at Ipokia Local Government as a sample frame. Multi-stage sampling was employed to break down the site into wards, streets, and different house numbers before randomizing administration of the questionnaires using face to face method, while purposive sampling was used for collecting verbal information through an in-depth interviews method. The population size for the site is 150.398, while 399 was the sample size derived from the use of Yamane sample size formula. After retrieval of structured questionnaires, 346 were found useful, while 10 percent (399) of the quantitative instruments was summed to 30 participants that were interviewed using the in-depth interviews technique. The result of the first hypothesis shows a composite relationship between the variables tested (independents and dependent). The result indicated that the porosity of the border, illegal possession of guns, and limited security staff jointly predispose insecurity among the residents of the selected study site. The result of the second hypothesis deciphers that the illegal gun possession (independent) variable predict business outcome among the residents of the study site because sporadic gun shoot will regress the business activities in the study area. The result of third result indicated that the independent (porosity of borders) variable predict social bonding network because a high level of insecurity will destroy the level of trust in the communication among the residents of the study area. The last questions give comprehensive meaning to one of the recommendations derived using content systematic analysis, which explains that out of 30 participants interviewed, 18 submitted individual involvement in monitoring communities will solve the problem, 7 out of 30 opines that governmental agents are to be trained for effective combat, 3 participants out 30 submits that the fight is for both government and the citizens while 2 participants out of 30 claimed that there must be an agreement between Nigerian and neighbouring countries on border security. International donors must totally control the sales of weapons to unauthorized personalities. Criminal cases must be treated with deterrence measures and target hardened procedures through decoying and blending, stakeout, and sting tactics.

Keywords: human security, illegal weapons, porous borders, development

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Authors: Niina Jallinoja, Anu Moisio

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Focus on adult learning is vital to overcome economic challenges as well as to respond to the demand for new competencies and sustained productivity in the digitalized world economy. Employees of all ages must be able to carry on continuous professional development to remain competitive in the labor market. According to EU policies, countries should offer more flexible opportunities for adult learners who study online and in so-called ‘second chance’ qualification programmes. Traditionally, adult education in Finland has comprised of not only liberal adult education but also the government funding to study for Bachelor, Master's, and Ph.D. degrees in Finnish Universities and Universities of Applied Sciences (UAS). From the beginning of 2021, public funding is allocated not only to degrees but also to courses to achieve new competencies for adult learners in Finland. Consequently, there will be degree students (often younger of age) and adult learners studying in the same evening, online and blended courses. The question is thus: How are combined studies meeting the different needs of degree students and adult learners? Haaga-Helia University of Applied Sciences (UAS), located in the metropolitan area of Finland, is taking up the challenge of continuous learning for adult learners. Haaga-Helia has been reforming the bachelor level education and respective shorter courses from 2019 in the biggest project in its history. By the end of 2023, Haaga-Helia will have a flexible, modular curriculum for the bachelor's degrees of hospitality management, business administration, business information technology, journalism and sports management. Building on the shared key competencies, degree students will have the possibility to build individual study paths more flexibly, thanks to the new modular structure of the curriculum. They will be able to choose courses across all degrees, and thus, build their own unique competence combinations. All modules can also be offered as separate courses or learning paths to non-degree students, both publicly funded and as commercial services for employers. Consequently, there will be shared course implementations for degree studies and adult learners with various competence requirements. The newly designed courses are piloted in parallel of the designing of the curriculum in Haaga-Helia during 2020 and 2021. Semi-structured online surveys are composed among the participants for the key competence courses. The focus of the research is to understand how students in the bachelor programme and adult learners from Open UAE perceive the learning experience in such a diverse learning group. A comparison is also executed between learning methods of in-site teaching, online implementation, blended learning and virtual self-learning courses to understand how the pedagogy is meeting the learning objectives of these two different groups. The new flexible curricula and the study modules are to be designed to fill the most important competence gaps that exist in the Finnish labor markets. The new curriculum will be dynamic and constantly evolving over time according to the future competence needs in the labor market. This type of approach requires constant dialogue between Haaga-Helia and workplaces during and after designing of the shared curriculum.

Keywords: ccompetence development, continuous learning, curriculum, higher education

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Authors: Isabel Latz, Mark Lusk, Josiah Heyman

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The rise of restrictive U.S. immigration policies and their strengthened enforcement has reportedly caused concerns among providers about their inadvertent effects on service utilization among Latinx and immigrant communities. This study presents perceptions on this issue from twenty service providers in health care, mental health, nutrition assistance, legal assistance, and immigrant advocacy in El Paso, Texas. All participants were experienced professionals, with fifteen in CEO, COO, executive director, or equivalent positions, and based at organizations that provide services for immigrant and/or low-income populations in a bi-national border community. Quantitative and qualitative data were collected by two primary investigators via semi-structured telephone interviews with an average length of 20 minutes. A survey script with closed and open-ended questions inquired about participants’ demographic information and perceptions of impacts of immigration enforcement policies under the current federal administration on their work and patient or client populations. Quantitative and qualitative data were analyzed to produce descriptive statistics and identify salient themes, respectively. Nearly all respondents stated that their work has been negatively (N=13) or both positively and negatively (N=5) affected by current immigration enforcement policies. Negative effects were most commonly related to immigration enforcement-related fear and uncertainty among patient or client populations. Positive effects most frequently referred to a sense of increased community organizing and greater cooperation among organizations. Similarly, the majority of service providers either reported an increase (N=8) or decrease (N=6) in service utilization due to changes in immigration enforcement policies. Increased service needs were primarily related to a need for public education about immigration enforcement policy changes, information about how new policies impact individuals’ service eligibility, legal status, and civil rights, as well as a need to correct misinformation. Decreased service utilization was primarily related to fear-related service avoidance. While providers observed changes in service utilization among undocumented immigrants and mixed-immigration status families, in particular, participants also noted ‘spillover’ effects on the larger Latinx community, including legal permanent and temporary residents, refugees or asylum seekers, and U.S. citizens. This study reveals preliminary insights into providers’ widespread concerns about the effects of current immigration enforcement policies on health, social, and legal service utilization among Latinx individuals. Further research is necessary to comprehensively assess impacts of immigration enforcement policies on service utilization in Latinx and immigrant communities. This information is critical to address gaps in service utilization and prevent an exacerbation of health disparities among Latinx, immigrant, and border populations. In a global climate of rising nationalism and xenophobia, it is critical for policymakers to be aware of the consequences of immigration enforcement policies on the utilization of essential services to protect the well-being of minority and immigrant communities.

Keywords: immigration enforcement, immigration policy, provider perceptions, service utilization

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Authors: Bello Gonzalez T. D. J., Setten Van M., Essen Van A., Brouwer M., Veldman K. T.

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Resistance to fluoroquinolones (FQ) has evolved increasingly over the years, posing a significant challenge for the treatment of human infections, particularly gastrointestinal tract infections caused by zoonotic bacteria transmitted through the food chain and environment. In broiler chickens, a relatively high proportion of FQ resistance has been observed in Escherichia coli indicator, Salmonella and Campylobacter isolates. We hypothesize that flumequine (Flu), used as a secondary choice for the treatment of poultry infections, could potentially be associated with a high proportion of FQ resistance. To evaluate this hypothesis, we used an in vitro fermentation chicken caeca model. Two continuous single-stage fermenters were used to simulate in real time the physiological conditions of the chicken caeca microbial content (temperature, pH, caecal content mixing, and anoxic environment). A pool of chicken caecal content containing FQ-resistant E. coli obtained from chickens at slaughter age was used as inoculum along with a spiked FQ-susceptible Campylobacter jejuni strain isolated from broilers. Flu was added to one of the fermenters (Flu-fermenter) every 24 hours for two days to evaluate the selection and maintenance of FQ resistance over time, while the other served as a control (C-Fermenter). The experiment duration was 5 days. Samples were collected at three different time points: before, during and after Flu administration. Serial dilutions were plated on Butzler culture media with and without Flu (8mg/L) and enrofloxacin (4mg/L) and on MacConkey culture media with and without Flu (4mg/L) and enrofloxacin (1mg/L) to determine the proportion of resistant strains over time. Positive cultures were identified by mass spectrometry and matrix-assisted laser desorption/ionization (MALDI). A subset of the obtained isolates were used for Whole Genome Sequencing analysis. Over time, E. coli exhibited positive growth in both fermenters, while C. jejuni growth was detected up to day 3. The proportion of Flu-resistant E. coli strains recovered remained consistent over time after antibiotic selective pressure, while in the C-fermenter, a decrease was observed at day 5; a similar pattern was observed in the enrofloxacin-resistant E. coli strains. This suggests that Flu might play a role in the selection and persistence of enrofloxacin resistance, compared to C-fermenter, where enrofloxacin-resistant E. coli strains appear at a later time. Furthermore, positive growth was detected from both fermenters only on Butzler plates without antibiotics. A subset of C. jejuni strains from the Flu-fermenter revealed that those strains were susceptible to ciprofloxacin (MIC < 0.12 μg/mL). A selection of E. coli strains from both fermenters revealed the presence of plasmid-mediated quinolone resistance (PMQR) (qnr-B19) in only one strain from the C-fermenter belonging to sequence type (ST) 48, and in all from Flu-fermenter belonged to ST189. Our results showed that Flu selective impact on PMQR-positive E. coli strains, while no effect was observed in C. jejuni. Maintenance of Flu-resistance was correlated with antibiotic selective pressure. Further studies into antibiotic resistance gene transfer among commensal and zoonotic bacteria in the chicken caeca content may help to elucidate the resistance spread mechanisms.

Keywords: fluoroquinolone-resistance, escherichia coli, campylobacter jejuni, in vitro model

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Authors: Pauline Calleja, Brooke Alexander

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In 2010 the College of Emergency Nursing Australasia (CENA) undertook sole administration of the Trauma Nursing Program (TNP) across Australia. The original TNP was developed from recommendations by the Review of Trauma and Emergency Services-Victoria. While participant and faculty feedback about the program was positive, issues were identified that were common for industry training programs in Australia. These issues included didactic approaches, with many lectures and little interaction/activity for participants. Participants were not necessarily encouraged to undertake deep learning due to the teaching and learning principles underpinning the course, and thus participants described having to learn by rote, and only gain a surface understanding of principles that were not always applied to their working context. In Australia, a trauma or emergency nurse may work in variable contexts that impact on practice, especially where resources influence scope and capacity of hospitals to provide trauma care. In 2011, a program review was undertaken resulting in major changes to the curriculum, teaching, learning and assessment approaches. The aim was to improve learning including a greater emphasis on pre-program preparation for participants, the learning environment and clinically applicable contextualized outcomes participants experienced. Previously if participants wished to undertake assessment, they were given a take home examination. The assessment had poor uptake and return, and provided no rigor since assessment was not invigilated. A new assessment structure was enacted with an invigilated examination during course hours. These changes were implemented in early 2012 with great improvement in both faculty and participant satisfaction. This presentation reports on a comparison of participant evaluations collected from courses post implementation in 2012 and in 2015 to evaluate if positive changes were sustained. Methods: Descriptive statistics were applied in analyzing evaluations. Since all questions had more than 20% of cells with a count of <5, Fisher’s Exact Test was used to identify significance (p = <0.05) between groups. Results: A total of fourteen group evaluations were included in this analysis, seven CENA TNP groups from 2012 and seven from 2015 (randomly chosen). A total of 173 participant evaluations were collated (n = 81 from 2012 and 92 from 2015). All course evaluations were anonymous, and nine of the original 14 questions were applicable for this evaluation. All questions were rated by participants on a five-point Likert scale. While all items showed improvement from 2012 to 2015, significant improvement was noted in two items. These were in regard to the content being delivered in a way that met participant learning needs and satisfaction with the length and pace of the program. Evaluation of written comments supports these results. Discussion: The aim of redeveloping the CENA TNP was to improve learning and satisfaction for participants. These results demonstrate that initial improvements in 2012 were able to be maintained and in two essential areas significantly improved. Changes that increased participant engagement, support and contextualization of course materials were essential for CENA TNP evolution.

Keywords: emergency nursing education, industry training programs, teaching and learning, trauma education

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Authors: Maria L. G. Lourenço, Keylla H. N. P. Pereira, Viviane Y. Hibaru, Fabiana F. Souza, João C. P. Ferreira, Simone B. Chiacchio, Luiz H. A. Machado

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The neonatal care of cats and dogs represents a challenge to veterinarians due to the small size of the newborns and their physiological particularities. In addition, many Veterinary Medicine colleges around the world do not include neonatology in the curriculum, which makes it less likely for the veterinarian to have basic knowledge regarding neonatal care and worsens the clinical care these patients receive. Therefore, lack of assistance and negligence have become frequent in the field, which contributes towards the high mortality rates. This study aims at describing cases and the main conditions pertaining to the neonatology clinical routine in cats and dogs, highlighting the importance of specialized care in this field of Veterinary Medicine. The study included 808 neonates admitted to the São Paulo State University (UNESP) Veterinary Hospital, Botucatu, São Paulo, Brazil, between January 2018 and November 2019. Of these, 87.3% (705/808) were dogs and 12.7% (103/808) were cats. Among the neonates admitted, 57.3% (463/808) came from emergency c-sections due to dystocia, 8.7% (71/808) cane from vaginal deliveries with obstetric maneuvers due to dystocia, and 34% (274/808) were admitted for clinical care due to neonatal conditions. Among the neonates that came from emergency c-sections and vaginal deliveries, 47.3% (253/534) was born in respiratory distress due to severe hypoxia or persistent apnea and required resuscitation procedure, such as the Jen Chung acupuncture point (VG26), oxygen therapy with mask, pulmonary expansion with resuscitator, heart massages and administration of emergency medication, such as epinephrine. On the other hand, in the neonatal clinical care, the main conditions and alterations observed in the newborns were omphalophlebitis, toxic milk syndrome, neonatal conjunctivitis, swimmer puppy syndrome, neonatal hemorrhagic syndrome, pneumonia, trauma, low weight at birth, prematurity, congenital malformations (cleft palate, cleft lip, hydrocephaly, anasarca, vascular anomalies in the heart, anal atresia, gastroschisis, omphalocele, among others), neonatal sepsis and other local and systemic bacterial infections, viral infections (feline respiratory complex, parvovirus, canine distemper, canine infectious traqueobronchitis), parasitical infections (Toxocara spp., Ancylostoma spp., Strongyloides spp., Cystoisospora spp., Babesia spp. and Giardia spp.) and fungal infections (dermatophytosis by Microsporum canis). The most common clinical presentation observed was the neonatal triad (hypothermia, hypoglycemia and dehydration), affecting 74.6% (603/808) of the patients. The mortality rate among the neonates was 10.5% (85/808). Being knowledgeable about neonatology is essential for veterinarians to provide adequate care for these patients in the clinical routine. Adding neonatology to college curriculums, improving the dissemination of information on the subject, and providing annual training in neonatology for veterinarians and employees are important to improve immediate care and reduce the mortality rates.

Keywords: neonatal care, puppies, neonatal, conditions

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Authors: Kamal Tolani, Sandeep Kumar, Rohit Luthra, Ankit Dadhania, Krishnaprasad K., Ram Gupta, Deepa Joshi

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Background: Post-operative analgesia remains a clinical challenge, with central and peripheral sensitization playing a pivotal role in treatment-related complications and impaired quality of life. Centrally acting opioids offer poor risk benefit profile with increased intensity of gastrointestinal or central side effects and slow onset of clinical analgesia. The objective of this study was to assess the clinical feasibility of induction and maintenance therapy with Tapentadol Nasal Spray (NS) in moderate to severe acute post-operative pain. Methods: Phase III, randomized, active-controlled, non-inferiority clinical trial involving 294 cases who had undergone surgical procedures under general anesthesia or regional anesthesia. Post-surgery patients were randomized to receive either Tapentadol NS 45 mg or Tramadol 100mg IV as a bolus and subsequent 50 mg or 100 mg dose over 2-3 minutes. The frequency of administration of NS was at every 4-6 hours. At the end of 24 hrs, patients in the tramadol group who had a pain intensity score of ≥4 were switched to oral tramadol immediate release 100mg capsule until the pain intensity score reduced to <4. All patients who had achieved pain intensity ≤ 4 were shifted to a lower dose of either Tapentadol NS 22.5 mg or oral Tramadol immediate release 50mg capsule. The statistical analysis plan was envisaged as a non-inferiority trial involving comparison with Tramadol for Pain intensity difference at 60 minutes (PID60min), Sum of Pain intensity difference at 60 minutes (SPID60min), and Physician Global Assessment at 24 hrs (PGA24 hrs). Results: The per-protocol analyses involved 255 hospitalized cases undergoing surgical procedures. The median age of patients was 38.0 years. For the primary efficacy variables, Tapentadol NS was non-inferior to Inj/Oral Tramadol in relief of moderate to severe post-operative pain. On the basis of SPID60min, no clinically significant difference was observed between Tapentadol NS and Tramadol IV (1.73±2.24 vs. 1.64± 1.92, -0.09 [95% CI, -0.43, 0.60]). In the co-primary endpoint PGA24hrs, Tapentadol NS was non–inferior to Tramadol IV (2.12 ± 0.707 vs. 2.02 ±0.704, - 0.11[95% CI, -0.07, 0.28). However, on further assessment at 48hr, 72 hrs, and 120hrs, clinically superior pain relief was observed with the Tapentadol NS formulation that was statistically significant (p <0.05) at each of the time intervals. Secondary efficacy measures, including the onset of clinical analgesia and TOTPAR, showed non-inferiority to Tramadol. The safety profile and need for rescue medication were also similar in both the groups during the treatment period. The most common concomitant medications were anti-bacterial (98.3%). Conclusion: Tapentadol NS is a clinically feasible option for improved compliance as induction and maintenance therapy while offering a sustained and persistent patient response that is clinically meaningful in post-surgical settings.

Keywords: tapentadol nasal spray, acute pain, tramadol, post-operative pain

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Authors: Maria Cristina Tommaso, Maria Das Graças L. Silva, Carlos Jose Pacheco

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Have the advances of the Brazilian legislation reflected or have been consonant with the inclusion of PwD in higher education? In 1990 the World Declaration on Education for All, a document organized by the United Nations Educational, Scientific and Cultural Organization (UNESCO), stated that the basic learning needs of people with disabilities, as they were called, required special attention. Since then, legislation in signatory countries such as Brazil has made considerable progress in guaranteeing, in a gradual and increasing manner, the rights of persons with disabilities to education. Principles, policies, and practices of special educational needs were created and guided action at the regional, national and international levels on the structure of action in Special Education such as administration, recruitment of educators and community involvement. Brazilian Education Law No. 3.284 of 2003 ensures inclusion of people with disabilities in Brazilian higher education institutions and also in 2015 the Law 13,146/2015 - Brazilian Law on the Inclusion of Persons with Disabilities (Statute of the Person with Disabilities) regulates the inclusion of PwD by the guarantee of their rights. This study analyses data related to people with disability inclusion in High Education in the south region of Rio de Janeiro State - Brazil during the period between 2008 and 2018, based in its correlation with the changes in the Brazilian legislation in the last ten years that were subjected by PwD inclusion processes in the Brazilian High Education Systems. The region studied is composed by sixteen cities and this research refers to the largest one, Volta Redonda that represents 25 percent of the total regional population. The PwD reception process had the dicing data at the Volta Redonda University Center with 35 percent of high education students in this territorial area. The research methodology analyzed the changes occurring in the legislation about the inclusion of people with disability in High Education in the last ten years and its impacts on the samples of this study during the period between 2008 and 2018. It was verified an expressive increasing of the number of PwD students, from two in 2008 to 190 PwD students in 2018. The data conclusions are presented in quantitative terms and the aim of this study was to verify the effectiveness of the PwD inclusion in High Education, allowing visibility of this social group. This study verified that the fundamental human rights guarantees have a strong relation to the advances of legislation and the State as a guarantor instance of the rights of the people with disability and must be considered a mean of consolidation of their education opportunities isonomy. The recognition of full rights and the inclusion of people with disabilities requires the efforts of those who have decision-making power. This study aimed to demonstrate that legislative evolution is an effective instrument in the social integration of people with disabilities. The study confirms the fundamental role of the state in guaranteeing human rights and demonstrates that legislation not only protects the interests of vulnerable social groups, but can also, and this is perhaps its main mission, to change behavior patterns and provoke the social transformation necessary to the reduction of inequality of opportunity.

Keywords: high education, inclusion, legislation, people with disability

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Authors: Bhupendra G. Prajapati, Alpesh R. Patel

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The aim of this research work is to develop sustained release multi-particulates dosage form of Dexketoprofen trometamol, which is the pharmacologically active isomer of ketoprofen. The objective is to utilization of active enantiomer with minimal dose and administration frequency, extended release multi-particulates dosage form development for better patience compliance was explored. Drug loaded and sustained release coated pellets were prepared by fluidized bed coating principle by wurster coater. Microcrystalline cellulose as core pellets, povidone as binder and talc as anti-tacking agents were selected during drug loading while Kollicoat SR 30D as sustained release polymer, triethyl citrate as plasticizer and micronized talc as an anti-adherent were used in sustained release coating. Binder optimization trial in drug loading showed that there was increase in process efficiency with increase in the binder concentration. 5 and 7.5%w/w concentration of Povidone K30 with respect to drug amount gave more than 90% process efficiency while higher amount of rejects (agglomerates) were observed for drug layering trial batch taken with 7.5% binder. So for drug loading, optimum Povidone concentration was selected as 5% of drug substance quantity since this trial had good process feasibility and good adhesion of the drug onto the MCC pellets. 2% w/w concentration of talc with respect to total drug layering solid mass shows better anti-tacking property to remove unnecessary static charge as well as agglomeration generation during spraying process. Optimized drug loaded pellets were coated for sustained release coating from 16 to 28% w/w coating to get desired drug release profile and results suggested that 22% w/w coating weight gain is necessary to get the required drug release profile. Three critical process parameters of Wurster coating for sustained release were further statistically optimized for desired quality target product profile attributes like agglomerates formation, process efficiency, and drug release profile using central composite design (CCD) by Minitab software. Results show that derived design space consisting 1.0 to 1.2 bar atomization air pressure, 7.8 to 10.0 gm/min spray rate and 29-34°C product bed temperature gave pre-defined drug product quality attributes. Scanning Image microscopy study results were also dictate that optimized batch pellets had very narrow particle size distribution and smooth surface which were ideal properties for reproducible drug release profile. The study also focused on optimized dexketoprofen trometamol pellets formulation retain its quality attributes while administering with common vehicle, a liquid (water) or semisolid food (apple sauce). Conclusion: Sustained release multi-particulates were successfully developed for dexketoprofen trometamol which may be useful to improve acceptability and palatability of a dosage form for better patient compliance.

Keywords: dexketoprofen trometamol, pellets, fluid bed technology, central composite design

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Authors: Azza A. Ali, Asmaa Abdelaty, Mona G. Khalil, Mona M. Kamal, Karema Abu-Elfotuh

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Background: Aluminium (Al) is known as a neurotoxin environmental pollutant that can cause certain diseases as Dementia, Alzheimer's disease, and Parkinsonism. It is widely used in antacid drugs as well as in food additives and toothpaste. Stresses have been linked to cognitive impairment; Social isolation (SI) may exacerbate memory deficits while protein malnutrition (PM) increases oxidative damage in cortex, hippocampus and cerebellum. The risk of cognitive decline may be lower by maintaining social connections. Epigallocatechin-3-gallate (EGCG) is the most abundant catechin in green tea and has antioxidant, anti-inflammatory and anti-atherogenic effects as well as health-promoting effects in CNS. Objective: To study the influence of different stressful conditions as social isolation, electric shock (EC) and inadequate Nutritional condition as PM on neurotoxicity induced by Al in rats as well as to investigate the possible protective effect of EGCG in these stressful and PM conditions. Methods: Rats were divided into two major groups; protected group which was daily treated during three weeks of the experiment by EGCG (10 mg/kg, IP) or non-treated. Protected and non-protected groups included five subgroups as following: One normal control received saline and four Al toxicity groups injected daily for three weeks by ALCl3 (70 mg/kg, IP). One of them served as Al toxicity model, two groups subjected to different stresses either by isolation as mild stressful condition (SI-associated Al toxicity model) or by electric shock as high stressful condition (EC- associated Al toxicity model). The last was maintained on 10% casein diet (PM -associated Al toxicity model). Isolated rats were housed individually in cages covered with black plastic. Biochemical changes in the brain as acetyl cholinesterase (ACHE), Aβ, brain derived neurotrophic factor (BDNF), inflammatory mediators (TNF-α, IL-1β), oxidative parameters (MDA, SOD, TAC) were estimated for all groups. Histopathological changes in different brain regions were also evaluated. Results: Rats exposed to Al for three weeks showed brain neurotoxicity and neuronal degenerations. Both mild (SI) and high (EC) stressful conditions as well as inadequate nutrition (PM) enhanced Al-induced neurotoxicity and brain neuronal degenerations; the enhancement induced by stresses especially in its higher conditions (ES) was more pronounced than that of inadequate nutritional conditions (PM) as indicated by the significant increase in Aβ, ACHE, MDA, TNF-α, IL-1β together with the significant decrease in SOD, TAC, BDNF. On the other hand, EGCG showed more pronounced protection against hazards of Al in both stressful conditions (SI and EC) rather than in PM .The protective effects of EGCG were indicated by the significant decrease in Aβ, ACHE, MDA, TNF-α, IL-1β together with the increase in SOD, TAC, BDNF and confirmed by brain histopathological examinations. Conclusion: Neurotoxicity and brain neuronal degenerations induced by Al were more severe with stresses than with PM. EGCG can protect against Al-induced brain neuronal degenerations in all conditions. Consequently, administration of EGCG together with socialization as well as adequate protein nutrition is advised especially on excessive Al-exposure to avoid the severity of its neuronal toxicity.

Keywords: environmental pollution, aluminum, social isolation, protein malnutrition, neuronal degeneration, epigallocatechin-3-gallate, rats

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Authors: Nanadcha Sinjindawong

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This article discusses the design process of a community mall called Castle of The Mall-dern. The concept behind this mall is to combine elements of a medieval castle with modern architecture. The author aims to create a building that fits into the surroundings while also providing users with the vibes of the ancient era. The total area used for the mall is 4,000 square meters, with three floors. The first floor is 1,500 square meters, the second floor is 1,750 square meters, and the third floor is 750 square meters. Research Aim: The aim of this research is to design a community mall that sells ancient clothes and accessories, and to combine sustainable architectural design with the ideas of ancient architecture in an urban area with convenient transportation. Methodology: The research utilizes qualitative research methods in architectural design. The process begins with calculating the given area and dividing it into different zones. The author then sketches and draws the plan of each floor, adding the necessary rooms based on the floor areas mentioned earlier. The program "SketchUp" is used to create an online 3D model of the community mall, and a physical model is built for presentation purposes on A1 paper, explaining all the details. Findings: The result of this research is a community mall with various amenities. The first floor includes retail shops, clothing stores, a food center, and a service zone. Additionally, there is an indoor garden with a fountain and a tree for relaxation. The second and third floors feature a void in the middle, with a few stores, cafes, restaurants, and studios on the second floor. The third floor is home to the administration and security control room, as well as a community gathering area designed as a public library with a café inside. Theoretical Importance: This research contributes to the field of sustainable architectural design by combining ancient architectural ideas with modern elements. It showcases the potential for creating buildings that blend historical aesthetics with contemporary functionality. Data Collection and Analysis Procedures: The data for this research is collected through a combination of area calculation, sketching, and building a 3D model. The analysis involves evaluating the design based on the allocated area, zoning, and functional requirements for a community mall. Question Addressed: The research addresses the question of how to design a community mall with a theme of ancient Medieval and Victorian eras. It explores how to combine sustainable architectural design principles with historical aesthetics to create a functional and visually appealing space. Conclusion: In conclusion, this research successfully designs a community mall called “Castle of The Mall-dern” that incorporates elements of Medieval and Victorian architecture. The building encompasses various zones, including retail shops, restaurants, community gathering areas, and service zones. It also features an interior garden and a public library within the mall. The research contributes to the field of sustainable architectural design by showcasing the potential for combining ancient architectural ideas with modern elements in an urban setting.

Keywords: 3D model, community mall, modern architecture, medieval architecture

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Authors: Ruth Goldschmidt, Vyacheslav Kalchenko, Lilah Agemy, Rachel Elmoalem, Avigdor Scherz

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Vascular Targeted Photodynamic therapy (VTP) is a new modality for selective cancer treatment that leads to the complete tumor ablation. A photosensitizer, a bacteriochlorophyll derivative in our case, is first administered to the patient and followed by the illumination of the tumor area, by a near-IR laser for its photoactivation. The photoactivated drug releases reactive oxygen species (ROS) in the circulation, which reacts with blood cells and the endothelium leading to the occlusion of the blood vasculature. If the blood vessels are only partially closed, the tumor may recover, and cancer cells could survive. On the other hand, excessive treatment may lead to toxicity of healthy tissues nearby. Simultaneous VTP monitoring and image processing independent of the photoexcitation laser has not yet been reported, to our knowledge. Here we present a method for blood flow monitoring, using a real-time laser speckle imaging (RTLSI) in the tumor during VTP. We have synthesized over the years a library of bacteriochlorophyll derivatives, among them WST11 and STL-6014. Both are water soluble derivatives that are retained in the blood vasculature through their partial binding to HSA. WST11 has been approved in Mexico for VTP treatment of prostate cancer at a certain drug dose, and time/intensity of illumination. Application to other bacteriochlorophyll derivatives or other cancers may require different treatment parameters (such as light/drug administration). VTP parameters for STL-6014 are still under study. This new derivative mainly differs from WST11 by its lack of the central Palladium, and its conjugation to an Arg-Gly-Asp (RGD) sequence. RGD is a tumor-specific ligand that is used for targeting the necrotic tumor domains through its affinity to αVβ3 integrin receptors. This enables the study of cell-targeted VTP. We developed a special RTLSI module, based on Labview software environment for data processing. The new module enables to acquire raw laser speckle images and calculate the values of the laser temporal statistics of time-integrated speckles in real time, without additional off-line processing. Using RTLSI, we could monitor the tumor’s blood flow following VTP in a CT26 colon carcinoma ear model. VTP with WST11 induced an immediate slow down of the blood flow within the tumor and a complete final flow arrest, after some sporadic reperfusions. If the irradiation continued further, the blood flow stopped also in the blood vessels of the surrounding healthy tissue. This emphasizes the significance of light dose control. Using our RTLSI system, we could prevent any additional healthy tissue damage by controlling the illumination time and restrict blood flow arrest within the tumor only. In addition, we found that VTP with STL-6014 was the most effective when the photoactivation was conducted 4h post-injection, in terms of tumor ablation success in-vivo and blood vessel flow arrest. In conclusion, RTSLI application should allow to optimize VTP efficacy vs. toxicity in both the preclinical and clinical arenas.

Keywords: blood vessel occlusion, cancer treatment, photodynamic therapy, real time imaging

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Authors: Alaa Abdellatif, Gabrièle Breda

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Background. Advanced therapy medicinal products (ATMPs) are innovative therapies that mainly target orphan diseases and high unmet medical needs. ATMP includes gene therapy medicinal products (GTMP), somatic cell therapy medicinal products (CTMP), and tissue-engineered therapies (TEP). Since legislation opened the way in 2007, 25 ATMPs have been approved in the EU, which is about the same amount as the U.S. Food and Drug Administration. However, not all of the ATMPs that have been approved have successfully reached the market and retained their approval. Objectives. We aim to understand all the factors limiting the market access to very promising therapies in a systemic approach, to be able to overcome these problems, in the future, with scientific, regulatory and commercial innovations. Further to recent reviews that focus either on specific countries, products, or dimensions, we will address all the challenges faced by ATMP development today. Methodology. We used mixed methods and a multi-level approach for data collection. First, we performed an updated academic literature review on ATMP development and their scientific and market access challenges (papers published between 2018 and April 2023). Second, we analyzed industry feedback from cell and gene therapy webinars and white papers published by providers and pharmaceutical industries. Finally, we established a comparative analysis of the regulatory guidelines published by EMA and the FDA for ATMP approval. Results: The main challenges in bringing these therapies to market are the high development costs. Developing ATMPs is expensive due to the need for specialized manufacturing processes. Furthermore, the regulatory pathways for ATMPs are often complex and can vary between countries, making it challenging to obtain approval and ensure compliance with different regulations. As a result of the high costs associated with ATMPs, challenges in obtaining reimbursement from healthcare payers lead to limited patient access to these treatments. ATMPs are often developed for orphan diseases, which means that the patient population is limited for clinical trials which can make it challenging to demonstrate their safety and efficacy. In addition, the complex manufacturing processes required for ATMPs can make it challenging to scale up production to meet demand, which can limit their availability and increase costs. Finally, ATMPs face safety and efficacy challenges: dangerous adverse events of these therapies like toxicity related to the use of viral vectors or cell therapy, starting material and donor-related aspects. Conclusion. As a result of our mixed method analysis, we found that ATMPs face a number of challenges in their development, regulatory approval, and commercialization and that addressing these challenges requires collaboration between industry, regulators, healthcare providers, and patient groups. This first analysis will help us to address, for each challenge, proper and innovative solution(s) in order to increase the number of ATMPs approved and reach the patients

Keywords: advanced therapy medicinal products (ATMPs), product development, market access, innovation

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