Search results for: clinical guidelines

Authors: Sheraz Gul

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The requirements for progressing a compound to clinical trials is well established and relies on the results from in-vitro and in-vivo animal tests to indicate that it is likely to be safe and efficacious when testing in humans. The typical data package required will include demonstrating compound safety, toxicity, bioavailability, pharmacodynamics (potential effects of the compound on body systems) and pharmacokinetics (how the compound is potentially absorbed, distributed, metabolised and eliminated after dosing in humans). If the desired criteria are met and the compound meets the clinical Candidate criteria and is deemed worthy of further development, a submission to regulatory bodies such as the US Food & Drug Administration for an exploratory Investigational New Drug Study can be made. The purpose of this study is to collect data to establish that the compound will not expose humans to unreasonable risks when used in limited, early-stage clinical studies in patients or normal volunteer subjects (Phase I). These studies are also designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on their effectiveness. In order to reach the above goals, we have developed a pre-clinical high throughput Absorption, Distribution, Metabolism and Excretion–Toxicity (ADME–Toxicity) panel of assays to identify compounds that are likely to meet the Lead and Candidate compound acceptance criteria. This panel includes solubility studies in a range of biological fluids, cell viability studies in cancer and primary cell-lines, mitochondrial toxicity, off-target effects (across the kinase, protease, histone deacetylase, phosphodiesterase and GPCR protein families), CYP450 inhibition (5 different CYP450 enzymes), CYP450 induction, cardio-toxicity (hERG) and gene-toxicity. This panel of assays has been applied to multiple compound series developed in a number of projects delivering Lead and clinical Candidates and examples from these will be presented.

Keywords: absorption, distribution, metabolism and excretion–toxicity , drug discovery, food and drug administration , pharmacodynamics

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Authors: Zoe Goldberger, Priscilla S. Briquez, Jeffrey A. Hubbell

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Tumor cells have mutations resulting from genetic instability that the immune system can actively recognize. Immune checkpoint immunotherapy (ICI) is commonly used in the clinic to re-activate immune reactions against mutated proteins, called neoantigens, resulting in tumor remission in cancer patients. However, only around 20% of patients show durable response to ICI. While tumor mutational burden (TMB) has been approved by the Food and Drug Administration (FDA) as a criterion for ICI therapy, the relevance of the subcellular localizations of the mutated proteins within the tumor cell has not been investigated. Here, we hypothesized that localization of mutations impacts the effect of immune responsiveness to ICI. We analyzed publicly available tumor mutation sequencing data of ICI treated patients from 3 independent datasets. We extracted the subcellular localization from the UniProtKB/Swiss-Prot database and quantified the proportion of membrane, cytoplasmic, nuclear, or secreted mutations per patient. We analyzed this information in relation to response to ICI treatment and overall survival of patients showing with 1722 ICI-treated patients that high mutational burden localized at the membrane (mTMB), correlate with ICI responsiveness, and improved overall survival in multiple cancer types. We anticipate that our results will ameliorate predictability of cancer patient response to ICI with potential implications in clinical guidelines to tailor ICI treatment. This would not only increase patient survival for those receiving ICI, but also patients’ quality of life by reducing the number of patients enduring non-effective ICI treatments.

Keywords: cancer, immunotherapy, membrane neoantigens, efficacy prediction, biomarkers

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Authors: Diana Vieira Figueiredo, Rita Ramos Miguel, Maria do Céu Salvador, Luiza Nobre-Lima, Daniel RIjo, Paula Vagos

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Social Anxiety Disorder (SAD) is characterized by a marked and persistent fear of social and/or performance situations in which one may be exposed to the scrutiny of others.  SAD has its usual onset and is highly prevalent during adolescence; if left untreated, it often has a chronic and unremitting course. So, it seems important to understand the psychological processes that might predict the development of SAD. One of these processes may be self-compassion, which has been found to be associated with social anxiety in both adults and adolescents. Self-compassion involves three main components, each with a positive (compassionate behavior) and negative (uncompassionate behavior) pole – self-kindness versus self-judgment, common humanity versus isolation, and mindfulness versus over-identification. The negative indicators of self-compassion (self-judgement, isolation, and over-identification) were found to be more strongly linked to mental health problems than the positive indicators (self-kindness, common humanity, and mindfulness). Additionally, negative associations were found between the positive indicators of self-compassion (self-kindness, common humanity, mindfulness) and psychopathology. The current study aimed to investigate the role of self-kindness, self-judgment, common humanity, isolation, mindfulness, and over-identification in the likelihood of an adolescent presenting SAD by comparing groups of normative and socially anxious adolescents. The sample consisted of 32 adolescents (Mage = 15.88, SD = .833) of which 23 were girls. Adolescents were assessed through a clinical structured interview that led 17 to be assigned to the clinical group (presenting a primary diagnosis of SAD) and 15 to be assigned to the non-clinical group (presenting no clinical diagnosis). Variables under study were measured through the Self-Compassion Scale for adolescents (SCS-A), which assesses the six indicators of self-compassion presented above. Six separate models were tested, each with one of the subscales of the SCS-A as the independent variable and with the group (clinical versus non-clinical) as the dependent variable. The models considering isolation, over-identification, self-judgement, and self-kindness fitted the data and accurately predicted group belonging for between 75% to 84.4% of cases. Results indicated that the log of the odds of an adolescent presenting SAD was positively related to isolation, over-identification, and self-judgement and negatively associated with self-kindness. Findings provide support for the idea that decreased self-compassion may place adolescents at increased risk for experiencing clinical levels of social anxiety: on the one hand, adolescents with higher levels of isolation, over-identification, and self-judgement seem to be more prone to the development of psychopathological levels of social anxiety; on the other hand, self-kindness may play a protective role in the development of SAD in this developmental phase. So, if focusing on social feared consequences and perceiving to be different from others may be distinctive features of SAD, developing self-kindness may be the antidote to promote diminished levels of social anxiety and more.

Keywords: adolescents, social anxiety disorder, self-compassion, diagnosis odds-ration

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Authors: Hongmeng Su, Luyu Zhao, Yanyan Qian, Hong Fan

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Aim: Hepatocellular carcinoma (HCC) is one of the most common malignant tumors that endanger human health seriously. RNA methylation, especially N6-methyladenosine (m⁶A) and 5-methylcytosine (m⁵C), a crucial epigenetic transcriptional regulatory mechanism, plays an important role in tumorigenesis, progression and prognosis. This research aims to systematically evaluate the prognostic value of m⁶A and m⁵C modulators in HCC patients. Methods: Twenty-four modulators of m⁶A and m⁵C were candidates to analyze their expression level and their contribution to predict the prognosis of HCC. Consensus clustering analysis was applied to classify HCC patients. Cox and LASSO regression were used to construct the risk model. According to the risk score, HCC patients were divided into high-risk and low/medium-risk groups. The clinical pathology factors of HCC patients were analyzed by univariate and multivariate Cox regression analysis. Results: The HCC patients were classified into 2 clusters with significant differences in overall survival and clinical characteristics. Nine-gene risk model was constructed including METTL3, VIRMA, YTHDF1, YTHDF2, NOP2, NSUN4, NSUN5, DNMT3A and ALYREF. It was indicated that the risk score could serve as an independent prognostic factor for patients with HCC. Conclusion: This study constructed a Nine-gene risk model by modulators of m⁶A and m⁵C and investigated its effect on the clinical prognosis of HCC. This model may provide important consideration for the therapeutic strategy and prognosis evaluation analysis of patients with HCC.

Keywords: hepatocellular carcinoma, m⁶A, m⁵C, prognosis, RNA methylation

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Authors: Alexandra McKinzie, Lucy Brown, Sarah Komanapalli, Sarah Swiezy, Caitlin Bernard

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Background: While 25% of US women will seek an abortion before age 45, targeted laws have led to a decline in abortion clinics, subsequently leaving 96% of Indiana counties and the 70% of Hoosier women residing in these counties without access to services they desperately need.1,2 Despite the need for a physician workforce that is educated and able to provide full-spectrum reproductive health care, few medical institutions have a standardized family planning and abortion pre-clinical curriculum. Methods: A Qualtrics survey was disseminated to students from Indiana University School of Medicine (IUSM) to evaluate (1) student interest in curriculum reform, (2) self-assessed preparedness to counsel on contraceptive and pregnancy options, and (3) preferred modality of instruction for family planning and abortion topics. Based on the pre-panel survey feedback, a case-based pregnancy options counseling panel will be implemented in the students’ pre-clinical, didactic course Endocrine, Reproductive, Musculoskeletal, Dermatologic Systems (ERMD) in February 2022. A Qualtrics post-panel survey will be disseminated to evaluate students’ perceived efficacy and quality of the panel, as well as their self-assessed preparedness to counsel on pregnancy options. Results: Participants in the pre-panel survey (n=303) were primarily female (61.72%) and White (74.43%). Across all class levels, many (60.80%) students expected to learn about family planning and abortion in their pre-clinical education. While most (84-88%) participants felt prepared to counsel about common, non-controversial pharmacotherapies (e.g. beta-blockers and diuretics), only 20% of students felt prepared to counsel on abortion options. Overall, 85.67% of students believed that IUSM should enhance its reproductive health coverage in pre-clinical, didactic courses. Traditional lectures, panels, and direct clinical exposure were the most popular instructional modalities. Expected Results: The authors predict that following the panel, students will indicate improved confidence in providing pregnancy options counseling. Additionally, students will provide constructive feedback on the structure and content of the panel for incorporation into future years’ curriculum. Conclusions: IUSM students overwhelmingly expressed interest in expanding their pre-clinical curriculum’s coverage of family planning and abortion topics. To specifically improve students’ self-assessed preparedness to provide pregnancy options counseling and address students’ self-cited learning gaps, a case-based provider panel session will be implemented in response to students’ preferred modality feedback.

Keywords: options counseling, family planning, abortion, curriculum reform, case-based panel

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Authors: Junaid Ahmed, Nandita Shenoy

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Maintaining lifelong knowledge and skills is essential for safe clinical practice. Continuing Professional Development (CPD) is an established method that can facilitate lifelong learning. It focuses on maintaining or developing knowledge, skills and relationships to ensure competent practice.To date, relatively little has been done to comprehensively and systematically synthesize evidence to identify subjects of interest among practising dentist. Hence the aim of our study was to identify areas in clinical practice that would be favourable for continuing professional dental education amongst practicing dentists. Participants of this study consisted of the practicing dental surgeons of Mangalore, a city in Dakshina Kannada, Karnataka. 95% of our practitioners felt that regular updating as a one day program once in 3-6 months is required, to keep them abreast in clinical practice. 60% of subjects feel that CPD programs enrich their theoretical knowledge and helps in patient care. 27% of them felt that CPD programs should be related to general dentistry. Most of them felt that CPD programs should not be charged nominally between one to two thousand rupees. The acronym ‘CPD’ should be seen in a broader view in which professionals continuously enhance not only their knowledge and skills, but also their thinking,understanding and maturity; they grow not only as professionals, but also as persons; their development is not restricted to their work roles, but may also extend to new roles and responsibilities.

Keywords: continuing professional development, competent practice, dental education, practising dentist

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Authors: Ida Madieha Abdul Ghani Azmi, Heng Gee Lim, Adlan Abdul Razak, Nasaruddin Abdul Rahman

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The objective of competition law is to maximise consumer welfare through the regulation of anti-competitive behaviour that results in the distortion of the market. Intellectual property law also seeks to enhance consumer welfare in the long run by encouraging the development of useful devices and processes. Nevertheless, in some circumstances, the IP owners behave in such a way that makes it difficult for rival companies to sell substitute products and technology in the market. Intellectual property owners may also reach a dominant position in the market such that they are able to dictate unfair terms and conditions on other market players. Among the two major categories of anti-competitive behavior is the use of horizontal and vertical agreement to constrain effective competition and abuse of dominant position. As a result, many countries have regulated the conduct of the IP owners that are considered as anti-competitive including the US, Canada, and Singapore. This paper visits the proposed IP Guidelines recently drafted by the Malaysian Competition Commission and investigates to what extent it resolves most of the anti-competitive behavior of the IP owners. The paper concludes by suggesting some of the rules that could be prescribed by the Competition Commission in order to maintain the relevancy of competition law as the main check against the abuse of rights by the intellectual property owners.

Keywords: abuse of dominant position, consumer welfare, intellectual property rights, vertical and horizontal agreements

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Authors: Clesse C., Lighezzolo-Alnot J., De Lavergne S.

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Considered as the most common surgical procedure worldwide, episiotomy can be defined as an incision around the vulva performed to enlarge it, in the aim of preventing the traumatic rupture of the perineum during childbirth. Rather mediatized, this practice raises many questions in the field of mental health, relayed by different users and health professionals. Today, is topicality is moderately hectic since many queries about the prophylactic exercise of episiotomy are subject to a relative consensus, particularly since WHO advocated in 1996 that only 10% of childbirths should involve an episiotomy. This indicator appeared after the publication of numerous results from randomized clinical trials. Unfortunately, these papers seem mostly centered about somatic impacts of episiotomy. From the side of psychological studies, they mostly integrate a major clinical methodological bias, especially considering that every primiparous woman is identical to the others face to the experience of parturition. In the aim to fill this lack of knowledge, we developed a longitudinal research starting in the 7th month of pregnancy and ending one year after delivery. We are studying in a comparative way different possible psychological consequences inherent to the use of episiotomy. To do this, we use a standardized methodology which combines semi-structured clinical interviews (IRMAG, IRMAN ...), free clinical interviews, a projective test (Rorschach) and five questionnaires (QIC, EPDS, CPQ WOMBLSQ4, SF36). Therefore, we can comprehend with shrewdness the question of psychic impacts of episiotomy in a qualitative and quantitative way by comparing it to other obstetric interventions. In this paper, we will present the first results obtained about a population of twenty-two primiparous women by focusing on body image, sexuality, quality of life, depressive affects, post-traumatic stress disorder and investment of the maternal role. Finally, we will consider the different implications and perspectives of this research which could improve the public health policies in the field of perinatal care.

Keywords: assessment, episiotomy, mental health, psychical impacts

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Authors: Maggie Hall, Haley O'Neill

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The U.S. faces a severe shortage of abortion providers, exacerbated by the June 2022 Dobbs v. Jackson Women’s Health Organization decision. Midwives, especially certified nurse midwives, are well-positioned to fill this gap in abortion care. However, a lack of clinical education and training prevents midwives from exercising their full scope of practice. National and international organizations that set obstetrics and midwifery education standards, including the International Confederation of Midwives, American College of Obstetricians and Gynecologists, and American Public Health Association, call for expansion of midwifery-managed abortion care through the first trimester. In the U.S., midwifery programs are accredited based on compliance with ACME standards and compliance is a prerequisite for the American Midwifery Certification Board exams. We conducted a literature review of studies in the last five years regarding abortion didactic and clinical education barriers via CINAHL, EBSCO and PubMed database reviews. We gave preference for primary sources within the last five years; however, due to the rapid changes in abortion education and access, we also included literature from 2012-2022. We evaluated ACME-accredited programs in relation to their geography within abortion-protected or restricted states and assessed state-specific barriers to abortion care education and provision as clinical students. There are 43 AMCB-accredited midwifery schools in 28 states across the U.S. Twenty schools (47%) are in the 15 states in which advanced practice clinicians can provide non-surgical abortion care, such as medication abortion and MVA procedures. Twenty-four schools (56%) are in the 16 states in which abortion care provision is restricted to Licensed Physicians and cannot offer in-state clinical training opportunities for midwifery students. Six schools are in the five states in which abortion is completely banned and are geographically concentrated in the southernmost region of the U.S., including Alabama, Kentucky, Louisiana, Tennessee, and Texas. Subsequently, these programs cannot offer in-state clinical training opportunities for midwifery students. Notably, there are seven ACME programs in six states that do not restrict abortion access by gestational age, including Colorado, Connecticut, Washington, D.C., New Jersey, New Mexico, and Oregon. These programs may be uniquely positioned for midwifery involvement in abortion care beyond the first trimester. While the following states don’t house ACME programs, abortion care can be provided by advanced practice clinicians in Rhode Island, Delaware, Hawaii, Maine, Maryland, Montana, New Hampshire, and Vermont, offering clinical placement and/or new ACME program development opportunities. We identify existing barriers to clinical education and training opportunities for midwifery-managed abortion care, which are both geographic and institutional in nature. We recommend expansion and standardization of clinical education and training opportunities for midwifery-managed abortion care in ACME-accredited programs to improve access to abortion care. Midwifery programs and teaching hospitals need to expand education, training, and residency opportunities for midwifery students to strengthen access to midwife-managed abortion care. ACNM and ACME should re-evaluate accreditation criteria and the implications of ACME programs in states where students are not able to learn abortion care in clinical contexts due to state-specific abortion restrictions.

Keywords: midwifery education, abortion, abortion education, abortion access

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Authors: Yaxian Chen, Yeonhee Park

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Driven by evolving FDA recommendations, modern clinical trials demand innovative designs that strike a balance between statistical rigor and ethical considerations. Covariate-adjusted response-adaptive (CARA) designs bridge this gap by utilizing patient attributes and responses to skew treatment allocation in favor of the treatment that is best for an individual patient’s profile. However, existing CARA designs for survival outcomes often hinge on specific parametric models, constraining their applicability in clinical practice. In this article, we address this limitation by introducing a CARA design for survival outcomes (CARAS) based on the Cox model and a variance estimator. This method addresses issues of model misspecification and enhances the flexibility of the design. We also propose a group sequential overlapweighted log-rank test to preserve type I error rate in the context of group sequential trials using extensive simulation studies to demonstrate the clinical benefit, statistical efficiency, and robustness to model misspecification of the proposed method compared to traditional randomized controlled trial designs and response-adaptive randomization designs.

Keywords: cox model, log-rank test, optimal allocation ratio, overlap weight, survival outcome

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Authors: Argyris Karapetsas, Maria Bampou, Andriani Mitropoulou

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The aim of the present work is to study the role of brain function in social awareness processing. Mind controls all the psychosomatic functions. Mind’s functioning enables individual not only to recognize one's own self and propositional attitudes, but also to assign such attitudes to other individuals, and to consider such observed mental states in the elucidation of behavior. Participants and Methods: Twenty (n=20) undergraduate students (mean age 18 years old) were involved in this study. Students participated in a clinical assessment, being conducted in Laboratory of Neuropsychology, at University of Thessaly, in Volos, Greece. Assessment included both electrophysiological (i.e.Event Related Potentials (ERPs) esp.P300 waveform) and neuropsychological tests (Raven's Progressive Matrices (RPM) and Sally-Anne test). Results: Initial assessment’s results confirmed statistically significant differences between the males and females, as well as in score performance to the tests applied. Strong correlations emerged between prefrontal lobe functioning, RPM, Sally-Anne test and P300 latencies. Also, significant dysfunction of mind has been found, regarding its three dimensions (straight, circular and helical). At the end of the assessment, students received consultation and appropriate guidelines in order to improve their intrapersonal and interpersonal skills. Conclusions: Mind and social awareness phenomena play a vital role in human development and may act as determinants of the quality of one’s own life. Meanwhile, brain function is highly correlated with social awareness and it seems that different set of brain structures are involved in social behavior.

Keywords: brain activity, emotions, ERP's, social awareness

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Authors: Ng Yen, Shafii Khamis, Rehir Bin Dahalan

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Cyclotrons in the energy range 10-30 MeV are widely used for the production of clincally relevant radiosiotopes used in positron emission tomography (PET) nuclear imaging. Positron emmision tomography is a powerful nuclear imaging tool that produces high quality 3-dimentional images of functional processes of body. The advantage of PET among all other imaging devices is that it allows the study of an impressive array of discrete biochemical and physiologic processes, within a single imaging session. The number of PET scanner increases every year globally due to high clinical demand. However, not all PET centers can afford a cyclotron, due to the expense associated with operation of an in-house cyclotron. Therefore, current research has also focused on the development of parent/daughter generators that can reliably provide PET nuclides. These generators (68Ge/68Ga generator, 62Zn/62Cu, 82Sr/82Rb, etc) can provide even short-lived radionuclides at any time on demand, without the need of an ‘in-house cyclotron’. The parent isotope is produced at a cyclotron/reactor facility, and can be shipped to remote clinical sites (regionally/overseas), where the daughter isotope is eluted, a model similar to the 99Mo/99mTc generator system. The specific aim for this presentation is to talk about the potential for both of the cyclotron and generator-produced PET radiopharmaceuticals used in clinical imaging.

Keywords: positron emission tomography, radiopharmaceutical, cyclotron, generator

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Authors: Célia Barreto Carvalho, Carolina da Motta, Marina Sousa, Joana Cabral, Ana Luísa Carvalho, Ermelindo Peixoto

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The aim of the current study was to develop and validate a Response to Stressful Situations Scale (RSSS) for the Portuguese population. This scale assesses the degree of stress experienced in scenarios that can constitute positive, negative and more neutral stressors, and also describes the physiological, emotional and behavioral reactions to those events according to their intensity. These scenario include typical stressor scenarios relevant to patients with schizophrenia, which are currently absent from most scale, assessing specific risks that these stressors may bring on subjects, which may prove useful in non-clinical and clinical populations (i.e. patients with mood or anxiety disorders, schizophrenia). Results from Principal Components Analysis and Confirmatory Factor Analysis of on two adult samples from general population allowed to confirm a three-factor model with good fit indices: χ2 (144)= 370.211, p = 0.000; GFI = 0.928; CFI = 0.927; TLI = 0.914, RMSEA = 0.055, P( rmsea ≤ 0.005) = 0.096; PCFI = 0.781. Further data analysis on the scale revealed that RSSS is an adequate assessment tool of stress response in adults to be used in further research and clinical settings, with good psychometric characteristics, adequate divergent and convergent validity, good temporal stability and high internal consistency.

Keywords: assessment, stress events, stress response, stress vulnerability

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Authors: Yutong Wan, John N. Wood

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Introduction: SCN9A encoded Nav1.7 is an ideal therapeutic target with minimal side effects for the pharmaceutical industry because SCN9A variants can cause both human gains of function pain-related mutations and loss of function pain-free mutations. This study reviews the clinical effectiveness of existing Nav1.7 inhibitors, which theoretically should be powerful analgesics. Methods: A systematic review is conducted on the effectiveness of current Nav1.7 blockers undergoing clinical trials. Studies were mainly extracted from PubMed, U.S. National Library of Medicine Clinical Trials, World Health Organization International Clinical Trials Registry, ISRCTN registry platform, and Integrated Research Approval System by NHS. Only studies with full text available and those conducted using double-blinded, placebo controlled, and randomised designs and reporting at least one analgesic measurement were included. Results: Overall, 61 trials were screened, and eight studies covering PF 05089771 (Pfizer), TV 45070 (Teva & Xenon), and BIIB074 (Biogen) met the inclusion criteria. Most studies were excluded because results were not published. All three compounds demonstrated insignificant analgesic effects, and the comparison between PF 05089771 and pregabalin/ibuprofen showed that PF 05089771 was a much weaker analgesic. All three drug candidates only have mild side effects, indicating the potentials for further investigation of Nav1.7 antagonists. Discussion: The failure of current Nav1.7 small molecule inhibitors might attribute to ignorance of the key role of endogenous systems in Nav1.7 null mutants, the lack of selectivity and blocking potency, and central impermeability. The synergistic combination of analgesic drugs, a recent UCL patent, combining a small dose of Nav1.7 blockers and opioids or enkephalinase inhibitors dramatically enhanced the analgesic effects. Conclusion: The current clinical testing Nav1.7 blockers are generally disappointing. However, the newer generation of Nav1.7 targeting analgesics has overcome the major constraints of its predecessors.

Keywords: chronic pain, Nav1.7 blockers, SCN9A, systematic review

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Authors: Sujan Mahamud

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Purpose: A major challenge in radiotherapy treatment is to deliver precise dose of radiation to the tumor with minimum dose to the healthy normal tissues. Recently, gel dosimetry has emerged as a powerful tool to measure three-dimensional (3D) dose distribution for complex delivery verification and quality assurance. These dosimeters act both as a phantom and detector, thus confirming the versatility of dosimetry technique. The aim of the study is to know the application of Gel Dosimeters in Radiotherapy and find out the comparison with 1D and 2D dimensional dosimeters. Methods and Materials: The study is carried out from Gel Dosimeter literatures. Secondary data and images have been collected from different sources such as different guidelines, books, and internet, etc. Result: Analyzing, verifying, and comparing data from treatment planning system (TPS) is determined that gel dosimeter is a very excellent powerful tool to measure three-dimensional (3D) dose distribution. The TPS calculated data were in very good agreement with the dose distribution measured by the ferrous gel. The overall uncertainty in the ferrous-gel dose determination was considerably reduced using an optimized MRI acquisition protocol and a new MRI scanner. The method developed for comparing measuring gel data with calculated treatment plans, the gel dosimetry method, was proven to be a useful for radiation treatment planning verification. In 1D and 2D Film, the depth dose and lateral for RMSD are 1.8% and 2%, and max (Di-Dj) are 2.5% and 8%. Other side 2D+ ( 3D) Film Gel and Plan Gel for RMSDstruct and RMSDstoch are 2.3% & 3.6% and 1% & 1% and system deviation are -0.6% and 2.5%. The study is investigated that the result fined 2D+ (3D) Film Dosimeter is better than the 1D and 2D Dosimeter. Discussion: Gel Dosimeters is quality control and quality assurance tool which will used the future clinical application.

Keywords: gel dosimeters, phantom, rmsd, QC, detector

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Authors: Lesley Metibogun, Regan Potangaroa

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Some existing sustainable public libraries in New Zealand now depend on air conditioning system for cooling. This seems completely contradictory to sustainable building initiatives. A sustainable building should be ‘self- sufficient’ and must aim at optimising the use of natural ventilation, wind and daylight and avoiding too much summer heat penetration into the building, to save energy consumption and enhance occupants’ comfort. This paper demonstrates that with appropriate architectural passive design input public libraries do not require air conditioning. Following a brief outline of how our dependence on air conditioning has spread over the full range of building types and climatic zones, this paper focuses on public libraries in temperate climates where passive cooling should be feasible for long periods of mild outside temperature. It was found that current design policies, regulations and guidelines and current building design practices militate passive cooling strategies. Perceived association with prestige, inflexibility of design process, rigid planning regulations and sustainability rating systems were identified as key factors forcing the need for air conditioning. Recommendations are made on how to further encourage development in this direction from the perspective of architectural design. This paper highlights how architectural passive cooling design strategies should be implemented in government initiated policies and regulations to develop a more sustainable public libraries.

Keywords: public library, sustainable design, temperate climate, passive cooling, air conditioning

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Authors: Mousa Saleh Daoud

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Rickets is a condition that affects the development of bones in children. It causes soft bones, which can become bowed or curved, this bending and curvature is evident in the age of Walking. The most common cause of rickets is dietary deficiency of vitamin D or Lack of exposure to sunlight or both together. The link between vitamin D and rickets has been known for many years and is well understood by doctors and scientists. If a child does not get enough of the vitamin D, the bones cannot form hard outer shells. This is why they become soft and weak. This study was conducted on children who reviewed by our medical clinic between the years 2011-2013. The study included 400 children, aged between one and six years. 11 children had clear clinical manifestations of rickets of varying degrees and all of them due to lack of vitamin D except for one case of rickets resistant to vitamin D. 389 cases ranged between natural and deficiency in vitamin D without clinical manifestations of Rickets.

Keywords: rickts, bone metabolic diseases, vitamin D, child

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Authors: Bhavani Veasuvalingam

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Case-based learning (CBL) is a popular instructional method aimed to bridge theory to clinical practice. This study aims to explore CBL mixed modality curriculum in influencing students’ learning styles and strategies that support learning. An explanatory sequential mixed method study was employed with initial phase, 44-itemed Felderman’s Index of Learning Style (ILS) questionnaire employed across year one medical students (n=142) using convenience sampling to describe the preferred learning styles. The qualitative phase utilised three focus group discussions (FGD) to explore in depth on the multimodal learning style exhibited by the students. Most students preferred combination of learning stylesthat is reflective, sensing, visual and sequential i.e.: RSVISeq style (24.64%) from the ILS analysis. The frequency of learning preference from processing to understanding were well balanced, with sequential-global domain (66.2%); sensing-intuitive (59.86%), active- reflective (57%), and visual-verbal (51.41%). The qualitative data reported three major themes, namely Theme 1: CBL mixed modalities navigates learners’ learning style; Theme 2: Multimodal learners active learning strategies supports learning. Theme 3: CBL modalities facilitating theory into clinical knowledge. Both quantitative and qualitative study strongly reports the multimodal learning style of the year one medical students. Medical students utilise multimodal learning styles to attain the clinical knowledge when learning with CBL mixed modalities. Educators’ awareness of the multimodal learning style is crucial in delivering the CBL mixed modalities effectively, considering strategic pedagogical support students to engage and learn CBL in bridging the theoretical knowledge into clinical practice.

Keywords: case-based learning, learnign style, medical students, learning

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Authors: Raheel Shakoor Siddiqui, Shahbaz Malik, Manikandar Srinivas Cheruvu, Sanjay Narayana Murthy, Livio DiMascio

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Background: elderly traumatic hip fracture patients frequently present to trauma services globally. Rising low energy falls amongst an osteoporotic aging population is the commonest cause for injury. Hip fractures in this population are a major cause for severe pain, morbidity and mortality. The term hip fracture is interchangeable with neck of femur fracture, fractured neck of femur or proximal femur fracture. Hip fracture pain management protocols and guidelines suggest conventional analgesia, nerve block and opioid based treatment as rescue analgesia. There is a current global opioid crisis with overuse, abuse and dependence. Adverse opioid related complications in vulnerable elderly patients further adds to morbidity and mortality. Systematic reviews in literature have evidenced superiority of multimodal analgesia in osteoarthritic primary joint replacements compared to opioids however, this has not yet been conducted for elderly traumatic hip fracture patients. Aims: The primary aim of this systematic review is to provide standardised evidence following Cochrane and PRISMA guidance in determining advantages of perioperative multimodal analgesia over conventional opioid based treatments in elderly traumatic hip fractures. Methods: 5 databases were searched from January 2000-2023 which identified 8 randomised controlled trials and 446 total participants. These trials met defined PICOS eligibility criteria of patient mean age ≥ 65 years presenting with a unilateral traumatic fractured neck of femur for operative intervention. Analgesic intervention with perioperative multimodal analgesia has been compared to conventional opioid based analgesia. Outcomes of interest include, primarily, the change in postoperative opioid consumption within a 0-30 postoperative period and secondarily, the change in postoperative adverse events and complications. A qualitative synthesis has been performed due to clinical heterogenicity and variance amongst trials. Results: GRADE evidence of moderate quality supports perioperative multimodal analgesia leads to a reduction in postoperative opioid consumption however, low quality evidence supports a reduction of adverse effects and complications. Conclusion: Perioperative multimodal analgesia whether used preoperative, intraoperative and/or postoperative leads to a reduction in postoperative opioid consumption for elderly traumatic hip fracture patients. This review recommends the use of perioperative multimodal analgesia as part of hip fracture pain protocols however, caution and clinical judgement should be used as the risk of adverse effects may not be lower.

Keywords: trauma, orthopaedics, hip, fracture, neck of femur fracture, analgesia, multimodal analgesia, opioid

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Authors: Mohamed Aly, Aliaa Rehan Youssef, Emad Sawerees, Mounir Guirgis

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Relevance: Osteoarthritis (OA) is the most common degenerative disease seen in all populations. It causes disability and substantial socioeconomic burden. Evidence supports that exercise are the most effective conservative treatment for patients with OA. Therapists experience and clinical judgment play major role in exercise prescription and scientific evidence for this regard is lacking. The development of clinical prediction rules to identify patients who are most likely benefit from exercise may help solving this dilemma. Purpose: This study investigated whether body mass index and functional ability at baseline can predict patients’ response to a selected exercise program. Approach: Fifty-six patients, aged 35 to 65 years, completed an exercise program consisting of open kinetic chain strengthening and passive stretching exercises. The program was given for 3 sessions per week, 45 minutes per session, for 6 weeks Evaluation: At baseline and post treatment, pain severity was assessed using the numerical pain rating scale, whereas functional ability was being assessed by step test (ST), time up and go test (TUG) and 50 feet time walk test (50 FTW). After completing the program, global rate of change (GROC) score of greater than 4 was used to categorize patients as successful and non-successful. Thirty-eight patients (68%) had successful response to the intervention. Logistic regression showed that BMI and 50 FTW test were the only significant predictors. Based on the results, patients with BMI less than 34.71 kg/m2 and 50 FTW test less than 25.64 sec are 68% to 89% more likely to benefit from the exercise program. Conclusions: Clinicians should consider the described strengthening and flexibility exercise program for patents with BMI less than 34.7 Kg/m2 and 50 FTW faster than 25.6 seconds. The validity of these predictors should be investigated for other exercise.

Keywords: clinical prediction rule, knee osteoarthritis, physical therapy exercises, validity

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Authors: Elad Vashdi

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It is common to find speech deficit among children diagnosed with Autism. It can be found in the clinical field and recently in research. One of the DSM-V criteria suggests a speech delay (Delay in, or total lack of, the development of spoken language), but doesn't explain the cause of it. A common perception among professionals and families is that the inability to talk results from the autism. Autism is a name for a syndrome which just describes a phenomenon and is defined behaviorally. Since it is not based yet on a physiological gold standard, one can not conclude the nature of a deficit based on the name of the syndrome. A wide retrospective research (n=270) which included children with motor speech difficulties was conducted in Israel. The study analyzed entry evaluations in a private clinic during the years 2006-2013. The data was extracted from the reports. High percentage of children diagnosed with Autism (60%) was found. This result demonstrates the high relationship between Autism and motor speech problem. It also supports recent findings in research of Childhood apraxia of speech (CAS) occurrence among children with ASD. Only small percentage of the participants in this research (10%) were diagnosed with CAS even though their verbal deficits well fitted the guidelines for CAS diagnosis set by ASHA in 2007. This fact raises questions regarding the diagnostic procedure in Israel. The understanding that CAS might highly exist within Autism and can have a remarkable influence on the course of early development should be a guiding tool within the diagnosis procedure. CAS can explain the nature of the speech problem among some of the autistic children and guide the treatment in a more accurate way. Calculating the prevalence of CAS which includes the comorbidity with ASD reveals new numbers and suggests treating differently the CAS population.

Keywords: childhood apraxia of speech, Autism, treatment, speech

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Authors: Selam Mulugeta, Barkot Milkias, Mesfin Araya, Abel Worku, Eyasu Mulugeta

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In Ethiopia, there is inadequate information on non-adherence to antidepressant treatment in patients with depressive disorders. Having awareness of the pattern of adherence is important in future prognosis, quality of life, and functionality in these patients. This hospital-based cross-sectional quantitative study was done on a sample of 216 consecutive outpatients with depressive disorders. Data were collected using questionnaires through in-person and phone call interviews. The 8-item Morisky scale was used to assess the pattern of medication adherence. Other specially developed tools were used to obtain sociodemographic and clinical information from electronic medical records and patient interviews. Data were analyzed using the Statistical Package for the Social Sciences Version - 25. Univariate and multivariable analyses were carried out to assess factors associated with non-adherence. 90% of the participants had a primary diagnosis of major depressive disorder. Based on the 8-item Morisky Medication Adherence Scale, the prevalence of non-adherence was found to be 84.7%. Living distance between 11 to 50 km from the hospital (AOR= 11, 95% CI (29,46.6)), post-secondary level of education (AOR= 8.3, 95% CI (1, 64.4)) and taking multiple medications (AOR= 6.1, 95% CI (1, 34.9)) were found to have significantly increased odds of non-adherence. Non-adherence was significantly associated with factors such as increased living distance from the hospital, relatively higher educational level, and polypharmacy. Proper and patient-centered psychoeducation, addressing the communication gap between patients and doctors, adherence to prescribing guidelines, avoiding polypharmacy unless indicated & working on accessibility of treatment is essential to decrease non-adherence.

Keywords: depressive disorders, Ethiopia, medication adherence, Addis Ababa

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Authors: Shu Hwang Ang, Choo Yee Yu, Geik Yong Ang, Yean Yean Chan, Yatimah Binti Alias, And Sook Mei Khor

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With the high prevalence of Type 2 diabetes mellitus across the world, the morbidities and mortalities associated with Type 2 diabetes have significant impact on the production line for a nation. With routine scheduled clinical visits to manage Type 2 diabetes, diabetic patients with hectic lifestyles can have low clinical compliance. Hence, it often decreases the effectiveness of diabetic management personalized for each diabetic patient. Here, we report a useful developed point-of-care (POC) device that detect glycated hemoglobin (HbA1c, biomarker for long-term Type 2 diabetic management). In fact, the established POC devices certified to be used in clinical setting are not only expensive ($ 8 to $10 per test), they also require skillful practitioners to perform sampling and interpretation. As a paper-based biosensor, the developed HbA1c biosensor utilized lateral flow principle to offer an alternative for cost-effective (approximately $2 per test) and end-user friendly device for household testing. Requiring as little as 2 L of finger-picked blood, the test can be performed at the household with just simple dilution and washings. With visual interpretation of numbers of test lines shown on the developed biosensor, it can be interpreted as easy as a urine pregnancy test, aided with scale of intensity provided. In summary, the developed HbA1c immunosensor has been tested to have high selectivity towards HbA1c, and is stable with reasonably good performance in clinical testing. Therefore, our developed HbA1c immunosensor has high potential to be an effective diabetic management tool to increase patient compliance and thus contain the progression of the diabetes.

Keywords: blood, glycated hemoglobin (HbA1c), lateral flow, type 2 diabetes mellitus

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Authors: Abdul Aziz, Muhammad Qamar Masood, Saadia Sattar, Saira Fatima, Najmul Islam

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Introduction: The most common endocrine tumor is thyroid cancer. Follicular Thyroid Carcinoma (FTC) accounts for 5%–10% of all thyroid cancers. Patients with FTC frequently present with more advanced stage diseases and a higher occurrence of distant metastases because of the propensity of vascular invasion. FTC is mainly treated with surgery, while radioactive iodine therapy is the main adjuvant therapy as per ATA guidelines. In many developing countries, surgical facilities and radioactive iodine are in short supply; therefore, understanding follicular thyroid cancer trends may help developing countries plan and use resources more effectively. Methodology: It was a retrospective observational study of FTC patients of age 18 years and above conducted at Aga Khan University Hospital, Karachi, from 1st January 2010 to 31st December 2019. Results: There were 404 patients with thyroid carcinoma, out of which forty (10.1%) were FTC. 50% of the patients were in the 41-60 years age group, and the female to male ratio was 1.5: 1. Twenty-four patients (60%) presented with complain of neck swelling followed by metastasis (20%) and compressive symptoms (20%). The most common site of metastasis was bone (87.5%), followed by lung (12.5%). The pre-operative thyroglobulin level was done in six out of eight metastatic patients (75%) in which it was elevated. This emphasizes the importance of checking thyroglobulin level in unusual presentation (bone pain, fractures) of a patient having neck swelling also to help in establishing the primary source of tumor. There was no complete documentation of ultrasound features of the thyroid gland in all the patients, which is an important investigation done in the initial evaluation of thyroid nodule. On FNAC, 50% (20 patients) had Bethesda category III-IV nodules, while 10% ( 4 patients ) had Bethesda category II. In sixteen patients, FNAC was not done as they presented with compressive symptoms or metastasis. Fifty percent had a total thyroidectomy and 50% had subtotal followed by completion thyroidectomy, plus ten patients had lymph node dissection, out of which seven had histopathological lymph node involvement. On histopathology, twenty-three patients (57.5%) had minimally invasive, while seventeen (42.5%) had widely invasive follicular thyroid carcinoma. The capsular invasion was present in thirty-three patients (82.5%); one patient had no capsular invasion, but there was a vascular invasion. Six patients' histopathology had no record of capsular invasion. In contrast, the lymphovascular invasion was present in twenty-six patients (65%). In this study, 65 % of the patients had clinical stage 1 disease, while 25% had stage 2 and 10% had clinical stage 4. Seventeen patients (42.5%) had received RAI 30-100 mCi, while ten patients (25%) received more than 100 mCi. Conclusion: FTC demographic and clinicopathological presentation are the same in Pakistan as compared to other countries. Surgery followed by RAI is the mainstay of treatment. Thus understanding the trend of FTC and proper planning and utilization of the resources will help the developing countries in effectively treating the FTC.

Keywords: thyroid carcinoma, follicular thyroid carcinoma, clinicopathological features, developing countries

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Authors: Mohammad Raihan Mukhlis, M. Abdur Rahman Bhuiyan

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Bangladesh is a developing country in which a lot of multi-span simply/continuous supported flyovers are being constructed in its major cities. Being situated in a seismically active region, seismic safety evaluation of flyovers is essential for seismic risk reduction. Effects of site amplification on seismic safety evaluation of flyover piers are the main concern of this study. In this regard, failure mode, lateral strength and displacement ductility of piers of a typical multi-span simply supported flyover have been evaluated by Japan Road Association (JRA) recommended guidelines, with and without considering site amplification. Ultimate flexural strengths of piers have been computed using the pushover analysis results. Shear capacity of piers has been calculated using the guidelines of JRA. Lateral strengths have been determined depending on the failure modes of the piers. Displacement ductility of piers has been computed using yield and ultimate displacements of the piers obtained from the pushover analysis results. Selected earthquake time history is used in seismic safety evaluation of the flyover piers. Finally, the ductility design method is used to conduct the seismic safety evaluation of the piers with and without considering site amplification. From the numerical results, it has been revealed that the effects of site amplification on seismic safety evaluation of bridge structures should be carefully taken into account.

Keywords: displacement ductility, flyover pier, lateral strength, safety evaluation, site amplification

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Authors: Fuad Hamsyah

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Since last two decades, major disasters have happened in the Philippines and Indonesia as two countries that are located in the pacific ring of fire territory. While in Southeast Asian countries, the process of psychosocial support provision is facing various constraints such as limited number of mental health professionals and the limited knowledge about the provision of psychosocial support for disaster survivors. Yet after the tsunami disaster in 2004, many Asian countries begin to develop policies about the provision of psychosocial interventions as an effort for future disasters preparedness. In addition, mental health professionals have to consider the local cultural values and beliefs in order to provide people with effective psychosocial support since cultural values and beliefs play a significant role in the diversity of psychological distress that forms symptoms formation, and people’s way to seek for psychological assistance. This study is a critical literature review on 130 relevant selected documents and literatures. IASC MHPSS guideline is used as the research framework in doing critical analysis. The purpose of this study is to conduct a critical analysis on the mental health and psychosocial support provision in the Philippines and Indonesia with three main objectives: 1) To describe strengths, weaknesses, and challenges in the process of psychosocial supports given by public and private organizations in emergency settings of disaster in the Philippines and Indonesia, 2) To compare psychosocial support practices between the Philippines and Indonesia, and to identify the good practices among these countries, 3) To learn how cultural values influence the implementation of psychosocial supports in emergency settings of disaster. This research indicated that almost every function from IASC MHPSS guidelines has been implemented effectively in the Philippines and Indonesia, yet not in every detail of IASC MHPSS guidelines. Several similarities and differences are indicated in this study also based on the IASC MHPSS guidelines as the analysis framework. Further, both countries have some good practices that can be useful as an example of a comprehensive psychosocial support implementation. Apart from the IASC MHPSS guideline, cultural values and beliefs in the Philippines such as kanya-kanya syndrome, pakikipakapwa, utang na loob, bahala na, pagkaya are indicated as several cultural values that have strong influences towards people’s attitude and behavior in disaster situations. While in Indonesia, several cultural values such as sabar and nrimo become two important attitudes to cope disaster situations.

Keywords: disaster, Indonesia, psychosocial support, Philippines

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Authors: Druzhinenko-Silhan Daria, Metz Claire

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In this paper, we introduce the findings of the "Conjugal violence: mothers' parenting and court decisions" (VIC-PADEJ) study, focusing on the motherhood experiences of domestic violence victims. Utilizing a longitudinal research protocol that encompassed clinical interviews, projective methods, and various questionnaires, we detail the outcomes derived from seven clinical interviews with mothers alongside a comprehensive analysis. The findings reveal a pronounced decline in security and an imperative need for structuring both social and internal realities. The convergence of these findings indicates that parenting, post-experiencing domestic violence, may become an unattainable task due to the deficiency of internal resources.

Keywords: domestic violence, parenthood, mothers victims, projective methods, longitudinal research, alceste analysis

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Authors: Milind D. Meshram

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Ascarids are the most frequent worm parasite of dogs and cats. There are two species that commonly infect dogs: Toxocara canis and Toxascaris leonina. Adult roundworms live in the stomach and intestines and can grow to 7 inches (18 cm) long. A female may lay 200,000 eggs in a day. The eggs are protected by a hard shell. They are extremely hardy and can live for months or years in the soil. A dog aged about 6 years, from Satara was referred to Teaching Veterinary Clinical Complex (TVCC) with a complaint of abdominal pain, anorexia, loss of condition and dull body coat with mucous pale membrane. The clinical examination revealed Anaemia, palpation of abdomen revealed enlargement of liver, slimy feel of the intestine loop, diarrhea.

Keywords: therapeutic management, Toxocara canis, induced hepatitis, dogs

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Authors: Araya Yordchim, Rosjana Chandhasa, Suwaree Yordchim

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This research aims to study guidelines on the development of management process for research journals in order to develop Suan Sunandha Rajabhat University to international standards. This research investigated affecting elements ranging from the format of the article, evaluation form for research article quality, the process of creating a scholarly journal, satisfaction level of those with knowledge and competency to conduct research, arisen problems, and solutions. Drawing upon the sample size of 40 persons who had knowledge and competency in conducting research and creating scholarly journal articles at an international level, the data for this research were collected using questionnaires as a tool. Through the usage of computer software, data were analyzed by using the statistics in the forms of frequency, percentage, mean, standard deviation, and multiple regression analysis. The majority of participants were civil servants with a doctorate degree, followed by civil servants with a master's degree. Among them, the suitability of the article format was rated at a good level while the evaluation form for research articles quality was assessed at a good level. Based on participants' viewpoints, the process of creating scholarly journals was at a good level, while the satisfaction of those who had knowledge and competency in conducting research was at a satisfactory level. The problems encountered were the difficulty in accessing the website. The solution to the problem was to develop a website with user-friendly accessibility, including setting up a Google scholar profile for the purpose of references counting and the articles being used for reference in real-time. Research article format influenced the level of satisfaction of those who had the knowledge and competency to conduct research with statistical significance at the 0.01 level. The research article quality assessment form (preface section, research article writing section, preparation for research article manuscripts section, and the original article evaluation form for the author) affected the satisfaction of those with knowledge and competency to conduct research with the statistical significance at the level of 0.01. The process of establishing journals had an impact on the satisfaction of those with knowledge and ability to conduct research with statistical significance at the level of .05

Keywords: guidelines, development of management, research journals, international standards

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Authors: Liane J. Ioannou, Jonathan Serpell, Joanne Dean, Cino Bendinelli, Jenny Gough, Dean Lisewski, Julie Miller, Win Meyer-Rochow, Stan Sidhu, Duncan Topliss, David Walters, John Zalcberg, Susannah Ahern

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Background: The occurrence of thyroid cancer is increasing throughout the developed world, including Australia and New Zealand, and since the 1990s has become the fastest increasing malignancy. Following the success of a number of institutional databases that monitor outcomes after thyroid surgery, the Australian and New Zealand Endocrine Surgeons (ANZES) agreed to auspice the development of a bi-national thyroid cancer registry. Objectives: To establish a bi-national population-based clinical quality registry with the aim of monitoring and improving the quality of care provided to patients diagnosed with thyroid cancer in Australia and New Zealand. Patients and Methods: The Australian and New Zealand Thyroid Cancer Registry (ANZTCR) captures clinical data for all patients, over the age of 18 years, diagnosed with thyroid cancer, confirmed by histopathology report, that have been diagnosed, assessed or treated at a contributing hospital. Data is collected by endocrine surgeons using a web-based interface, REDCap, primarily via direct data entry. Results: A multi-disciplinary Steering Committee was formed, and with operational support from Monash University the ANZTCR was established in early 2017. The pilot phase of the registry is currently operating in Victoria, New South Wales, Queensland, Western Australia and South Australia, with over 30 sites expected to come on board across Australia and New Zealand in 2018. A modified-Delphi process was undertaken to determine the key quality indicators to be reported by the registry, and a minimum dataset was developed comprising information regarding thyroid cancer diagnosis, pathology, surgery, and 30-day follow up. Conclusion: There are very few established thyroid cancer registries internationally, yet clinical quality registries have shown valuable outcomes and patient benefits in other cancers. The establishment of the ANZTCR provides the opportunity for Australia and New Zealand to further understand the current practice in the treatment of thyroid cancer and reasons for variation in outcomes. The engagement of endocrine surgeons in supporting this initiative is crucial. While the pilot registry has a focus on early clinical outcomes, it is anticipated that future collection of longer-term outcome data particularly for patients with the poor prognostic disease will add significant further value to the registry.

Keywords: thyroid cancer, clinical registry, population health, quality improvement

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