Search results for: complementary therapy

Authors: Tso Sheng-Yang, Wang Tien-Ni

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Introduction and Purpose: Previous researchers have documented children with ASD (Autism Spectrum Disorders) prefer to escaping internal privates and external privates when they face tough conditions they can’t control or they don’t like.Especially, when children with ASD need to learn challenging tasks, such us Chinese language, their inappropriate behaviors will occur apparently. Recently, researchers apply positive behavior support strategies for children with ASD to enhance their self-efficacy and therefore to reduce their adverse behaviors. Thus, the purpose of this research was to design a series of lecture based on art therapy and to evaluate its effectiveness on the child’s self-efficacy. Method: This research was the single-case design study that recruited a high school boy with ASD. Whole research can be separated into three conditions. First, baseline condition, before the class started and ended, the researcher collected participant’s competencies of self-efficacy every session. In intervention condition, the research used dramatic conventions to teach the child in Chinese language twice a week.When the data was stable across three documents, the period entered to the maintenance condition. In maintenance condition, the researcher only collected the score of self-efficacynot to do other interventions five times a month to represent the effectiveness of maintenance.The time and frequency of data collection among three conditions are identical. Concerning art therapy, the common approach, e.g., music, drama, or painting is to use art medium as independent variable. Due to visual cues of art medium, the ASD can be easily to gain joint attention with teachers. Besides, the ASD have difficulties in understanding abstract objectives Thus, using the drama convention is helpful for the ASD to construct the environment and understand the context of Classical Chinese. By real operation, it can improve the ASD to understand the context and construct prior knowledge. Result: Bassd on the 10-points Likert scale and research, we product following results. (a) In baseline condition, the average score of self-efficacyis 1.12 points, rangedfrom 1 to 2 points, and the level change is 0 point. (b)In intervention condition, the average score of self-efficacy is 7.66 points rangedfrom 7 to 9 points, and the level change is 1 point. (c)In maintenance condition, the average score of self-efficacy is 6.66 points rangedfrom 6 to 7 points, and the level change is 1 point. Concerning immediacy of change, between baseline and intervention conditions, the difference is 5 points. No overlaps were found between these two conditions. Conclusion: According to the result, we find that it is effective that using dramatic conventions a s teaching strategies to teach children with ASD. The result presents the score of self-efficacyimmediately enhances when the dramatic conventions commences. Thus, we suggest the teacher can use this approach and adjust, based on the student’s trait, to teach the ASD on difficult task.

Keywords: dramatic conventions, autism spectrum disorder, slef-efficacy, teaching strategy

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Authors: Navah Z. Ratzon, Rachel Shichrur

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Background: Many studies have assessed and identified the risk factors of safe driving, but there is relatively little research-based evidence concerning the ability to improve the driving skills of drivers in general and in particular of bus drivers, who are defined as a population at risk. Accidents involving bus drivers can endanger dozens of passengers and cause high direct and indirect damages. Objective: To examine the effectiveness of a metacognitive-functional intervention program for the reduction of risk factors among professional drivers relative to a control group. Methods: The study examined 77 bus drivers working for a large public company in the center of the country, aged 27-69. Twenty-one drivers continued to the intervention stage; four of them dropped out before the end of the intervention. The intervention program we developed was based on previous driving models and the guiding occupational therapy practice framework model in Israel, while adjusting the model to the professional driving in public transportation and its particular risk factors. Treatment focused on raising awareness to safe driving risk factors identified at prescreening (ergonomic, perceptual-cognitive and on-road driving data), with reference to the difficulties that the driver raises and providing coping strategies. The intervention has been customized for each driver and included three sessions of two hours. The effectiveness of the intervention was tested using objective measures: In-Vehicle Data Recorders (IVDR) for monitoring natural driving data, traffic accident data before and after the intervention, and subjective measures (occupational performance questionnaire for bus drivers). Results: Statistical analysis found a significant difference between the degree of change in the rate of IVDR perilous events (t(17)=2.14, p=0.046), before and after the intervention. There was significant difference in the number of accidents per year before and after the intervention in the intervention group (t(17)=2.11, p=0.05), but no significant change in the control group. Subjective ratings of the level of performance and of satisfaction with performance improved in all areas tested following the intervention. The change in the ‘human factors/person’ field, was significant (performance : t=- 2.30, p=0.04; satisfaction with performance : t=-3.18, p=0.009). The change in the ‘driving occupation/tasks’ field, was not significant but showed a tendency toward significance (t=-1.94, p=0.07,). No significant differences were found in driving environment-related variables. Conclusions: The metacognitive-functional intervention significantly improved the objective and subjective measures of safety of bus drivers’ driving. These novel results highlight the potential contribution of occupational therapists, using metacognitive functional treatment, to preventing car accidents among the healthy drivers population and improving the well-being of these drivers. This study also enables familiarity with advanced technologies of IVDR systems and enriches the knowledge of occupational therapists in regards to using a wide variety of driving assessment tools and making the best practice decisions.

Keywords: bus drivers, IVDR, human risk factors, metacognitive-functional intervention

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Authors: Steven M. Sanders, April T. Berry, David W. Hollingsworth

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Previous research has shown that veterans have higher rates of mental health concerns compared to non-veteran populations. A potential risk factor for the development of mental health concerns (i.e., depression & anxiety), particularly in Black veterans, is psychological inflexibility. Psychological inflexibility, a component of Acceptance & Commitment Therapy (ACT), is a process by which behavior is expressed in ways that attempt to control emotional and psychological reactions to uncomfortable stimuli and situations rather than by direct contingencies or personal values. The present study explored the relationship between psychological inflexibility, symptoms of depression, and symptoms of anxiety in a sample of 131 Black veterans. Results demonstrated that Black veterans who endorsed psychological inflexibility also endorsed higher levels of both depression and anxiety symptomology. These findings indicate the deleterious consequences of experiencing psychological inflexibility, which could be treated through ACT.

Keywords: psychological flexibility, veteran, black, psychological distress

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Authors: Andrea L. Arnett, Ann T. Packard, Yolanda I. Garces, Kenneth W. Merrell

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Objective: Pathologic response following neoadjuvant chemoradiation (CRT) has been associated with improved overall survival (OS). Conflicting results have been reported regarding the pathologic predictive value of positron emission tomography (PET) response in patients with stage III lung cancer. The aim of this study was to evaluate the correlation between post-treatment PET response and pathologic response utilizing novel FDG-PET parameters. Methods: This retrospective study included patients with non-metastatic, stage IIIA (N2) NSCLC cancer treated with CRT followed by resection. All patients underwent PET prior to and after neoadjuvant CRT. Univariate analysis was utilized to assess correlations between PET response, nodal clearance, pCR, and near-complete pathologic response (defined as the microscopic residual disease or less). Maximal standard uptake value (SUV), standard uptake ratio (SUR) [normalized independently to the liver (SUR-L) and blood pool (SUR-BP)], metabolic tumor volume (MTV), and total lesion glycolysis (TLG) were measured pre- and post-chemoradiation. Results: A total of 44 patients were included for review. Median age was 61.9 years, and median follow-up was 2.6 years. Histologic subtypes included adenocarcinoma (72.2%) and squamous cell carcinoma (22.7%), and the majority of patients had the T2 disease (59.1%). The rate of pCR and near-complete pathologic response within the primary lesion was 28.9% and 44.4%, respectively. The average reduction in SUVmₐₓ was 9.2 units (range -1.9-32.8), and the majority of patients demonstrated some degree of favorable treatment response. SUR-BP and SUR-L showed a mean reduction of 4.7 units (range -0.1-17.3) and 3.5 units (range –1.7-12.6), respectively. Variation in PET response was not significantly associated with histologic subtype, concurrent chemotherapy type, stage, or radiation dose. No significant correlation was found between pathologic response and absolute change in MTV or TLG. Reduction in SUVmₐₓ and SUR were associated with increased rate of pathologic response (p ≤ 0.02). This correlation was not impacted by normalization of SUR to liver versus mediastinal blood pool. A threshold of > 75% decrease in SUR-L correlated with near-complete response, with a sensitivity of 57.9% and specificity of 85.7%, as well as positive and negative predictive values of 78.6% and 69.2%, respectively (diagnostic odds ratio [DOR]: 5.6, p=0.02). A threshold of >50% decrease in SUR was also significantly associated pathologic response (DOR 12.9, p=0.2), but specificity was substantially lower when utilizing this threshold value. No significant association was found between nodal PET parameters and pathologic nodal clearance. Conclusions: Our results suggest that treatment response to neoadjuvant therapy as assessed on PET imaging can be a predictor of pathologic response when evaluated via SUV and SUR. SUR parameters were associated with higher diagnostic odds ratios, suggesting improved predictive utility compared to SUVmₐₓ. MTV and TLG did not prove to be significant predictors of pathologic response but may warrant further investigation in a larger cohort of patients.

Keywords: lung cancer, positron emission tomography (PET), standard uptake ratio (SUR), standard uptake value (SUV)

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Authors: Beatriz Mella Lira, Karla Yohannessen, Robin Hickman

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The aim of the paper is recognising inequalities through the self-assessment of health-related factors, in the context of daily mobilities in Santiago de Chile. Human capabilities will be used as the theoretical basis for the recognition and assessment of these factors regarding the functioning (what people are currently able to do) and capabilities (what people want to achieve and what is valuable for them), reflecting differences across social groups and among types of transport users. The self-assessment of health-related factors considers perceptions of stress, physical effort, proximity to other transport users, pollution, safety, and comfort. The types of transport users are classified as: private (cars, taxis, colectivos, motos), public (buses and metro) and active (bicycles and walking). The methodology follows a capability-based questionnaire, which was applied in different areas of Santiago de Chile, considering concepts extracted from the human capabilities list. The self-assessment of these health-related factors examines the context of peoples’ mobilities for performing their daily activities, considering socioeconomic differences as income, age, gender, disabilities, residence location and primary mode choice. The paper uses Relative Importance Index (RII) for weighting the relative influence or valuation of the factors. The respondents were asked to rate the importance of each factor on a scale from 1 to 5, in an ascending order of importance. The results suggest that these health-related factors impact not just the perceptions of users, but their well-being and their propensity for achieving their capabilities and the things they value in life. The paper is focused on the development of an applicable approach, measuring factors that should be included in transport project appraisal, as a more comprehensive and complementary method.

Keywords: active transport, health, human capabilities, Santiago de Chile, transport inequalities, transportation planning, urban planning

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Authors: Nazeema Ahmed

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Mental health in higher education has received increasing attention over the past few decades. The high academic demands of the engineering degree, coupled with students’ mental health challenges, have led to higher education institutions offering psychotherapeutic services to students. This paper discusses an evaluation of the psychotherapy service at the University of Cape Town. The aim was to determine (i) the efficacy of the service; and (ii) the impact of race, gender, and language of the therapist on the students’ therapeutic process. An online survey was sent to 109 students who attended psychotherapy. The majority expressed favorable experiences of psychotherapy, with reports of increased capacity to engage with their academic work. Most students did not experience the gender, race, or language of the psychologists to be barriers to their therapy. The findings point to a need for ongoing psychological support for students.

Keywords: psychotherapy, efficacy, engineering, education

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Authors: Faris Elghaish, Sepehr Abrishami, Mark Gaterell, Richard Wise

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The collaboration and integration between all building information management (BIM) processes and tasks are necessary to ensure that all project objectives can be delivered. The literature review has been used to explore the state of the art BIM technologies to manage construction materials as well as the challenges which have faced the construction process using traditional methods. Thus, this paper aims to articulate a framework to integrate traditional material planning methods such as ABC analysis theory (Pareto principle) to analyse and categorise the project materials, as well as using independent material planning methods such as Economic Order Quantity (EOQ) and Fixed Order Point (FOP) into the BIM 4D, and 5D capabilities in order to articulate a dependent material planning cycle into BIM, which relies on the constructability method. Moreover, we build a model to connect between the material planning outputs and the BIM 4D and 5D data to ensure that all project information will be accurately presented throughout integrated and complementary BIM reporting formats. Furthermore, this paper will present a method to integrate between the risk management output and the material management process to ensure that all critical materials are monitored and managed under the all project stages. The paper includes browsers which are proposed to be embedded in any 4D BIM platform in order to predict the EOQ as well as FOP and alarm the user during the construction stage. This enables the planner to check the status of the materials on the site as well as to get alarm when the new order will be requested. Therefore, this will lead to manage all the project information in a single context and avoid missing any information at early design stage. Subsequently, the planner will be capable of building a more reliable 4D schedule by allocating the categorised material with the required EOQ to check the optimum locations for inventory and the temporary construction facilitates.

Keywords: building information management, BIM, economic order quantity, EOQ, fixed order point, FOP, BIM 4D, BIM 5D

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Authors: Shao-Ju Chien, Yi-Chien Wu, Ting-Ying Huang, Li-Tsen Li, You-Jin Chen, Cheng-Nan Chen

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Homocysteine and pro-inflammatory mediators such as cyclooxygenase-2 (COX-2) have been linked to vascular dysfunction and risks of cardiovascular diseases. Fulvic acid (FA) is class of compounds of humic substances and possesses various pharmacological properties. However, the effect of FA on inflammatory responses of the monocytes remains unclear. We investigated the regulatory effect of FA on homocysteine-induced COX-2 expression in human monocytes. Peripheral blood monocytes and U937 cells were kept as controls or pre-treated with FA, and then stimulated with homocysteine. The results show that pretreating monocytes with FA inhibited the homocysteine-induced COX-2 expression in a dose-dependent manner. The inhibitor for nuclear factor-kB (NF-kB) attenuated homocysteine-induced COX-2 expression. Our findings provide a molecular mechanism by which FA inhibit homocysteine-induced COX-2 expression in monocytes, and a basis for using FA in pharmaceutical therapy against inflammation.

Keywords: homocysteine, monocytes, cyclooxygenase-2, fulvic acid, anti-inflammation

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Authors: Laura Cami Vorpsi

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This research paper examines the potential of private law as a means to promote and safeguard human rights while also addressing the associated challenges and limitations of adopting such an approach. Historically, private law mechanisms, namely contract law, tort law, and property law, have been employed to govern and oversee private relationships and transactions. Nevertheless, it is increasingly acknowledged that private law can also assume a significant role in safeguarding and advancing human rights, particularly in circumstances where the safeguards provided by public law are insufficient or inaccessible. This study assesses the benefits associated with the utilization of private law as a complementary measure to public law safeguards. These advantages encompass enhanced efficacy and efficiency of remedies, as well as the capacity to customize solutions to suit the unique requirements and circumstances of individuals. Nevertheless, the present study also considers the constraints associated with private law mechanisms, such as the financial and procedural intricacies of legal proceedings, the possibility of imbalanced negotiation power, and the potential to worsen pre-existing disparities and systemic inequities. The paper posits that the adoption of a private law-based approach to human rights necessitates a meticulous design and implementation process in order to mitigate potential risks and optimize the advantages. In conclusion, this study examines the ramifications of these discoveries on policy and practice, highlighting the necessity for heightened awareness and education regarding the capacity of private law to advance and safeguard human rights. Additionally, it underscores the significance of establishing efficient and easily accessible mechanisms for upholding human rights within the private domain. The paper concludes by providing recommendations for future research in this domain, specifically emphasizing the necessity for additional empirical investigations to assess the efficacy and consequences of private law-oriented strategies in safeguarding human rights.

Keywords: private law, human rights, promoting, protecting, access to justice

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Authors: Tahar Tayachi, Ahlam Alrehaili

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Purpose: The purpose of this paper is to investigate the relationship between the corporate board characteristics and the dividend policy among firms on the Saudi Stock Exchange. Design/Methodology/Approach: This paper uses a sample of 103 nonfinancial firms over a time period of 4 years from 2015 to 2018. To investigate how corporate governance mechanisms such as board independence, the board size, frequency of meetings, and free cash flow impact dividends, the study uses Logit and Tobit models. Findings: This paper finds that board size, board independence, and frequency of board meetings have no influence on a firm’s decision to pay dividends, while board size has a significantly positive impact on the levels of cash dividends paid to investors. This study also finds that the level of free cash flows has a positively significant influence on both the decision to pay dividends and the magnitude of dividend payouts. Research Limitations/Implications: This paper attempts to study the effectiveness of dividend policy among some firms on the Saudi Stock Exchange. Practical Implications: The findings reveal that board characteristics, which represent one of the crucial mechanisms of corporate governance, were found to be complementary to corporate laws and regulations imposed on the Saudi market in 2015. The findings also imply that capital market authorities should revise their corporate regulations and ensure that protection laws are adequate and strong enough to protect the interests of all shareholders. Originality/Value: This paper is among the few studies focusing on dividend policy in Saudi Arabia. Finally, these findings suggest that the improvements in corporate laws in Saudi Arabia led to such an outcome, and it has become prevalent in dividend policy decisions and behaviors of Saudi firms.

Keywords: agency theory, Tobit, corporate governance, dividend payout, Logit

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Authors: Aminu Abdullahi Isyaku

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Semi-arid Bornu basin in northeast Nigeria is characterised with flat topography, thick cover sediments and lack of continuous bedrock outcrops discernible for field geology. This paper presents the methodology for the characterisation of neotectonic surface structures and surface lithology in the north-eastern Bornu basin in northeast Nigeria as an alternative approach to field geological mapping using free multispectral Landsat 7 ETM+, SRTM DEM and ASAR Earth Observation datasets. Spectral lithological mapping herein developed utilised spectral discrimination of the surface features identified on Landsat 7 ETM+ images to infer on the lithology using four steps including; computations of band combination images; band ratio images; supervised image classification and inferences of the lithological compositions. Two complementary approaches to lineament mapping are carried out in this study involving manual digitization and automatic lineament extraction to validate the structural lineaments extracted from the Landsat 7 ETM+ image mosaic covering the study. A comparison between the mapped surface lineaments and lineament zones show good geospatial correlation and identified the predominant NE-SW and NW-SE structural trends in the basin. Topographic profiles across different parts of the Bama Beach Ridge palaeoshorelines in the basin appear to show different elevations across the feature. It is determined that most of the drainage systems in the northeastern Bornu basin are structurally controlled with drainage lines terminating against the paleo-lake border and emptying into the Lake Chad mainly arising from the extensive topographic high-stand Bama Beach Ridge palaeoshoreline.

Keywords: Bornu Basin, lineaments, spectral lithology, tectonics

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Authors: Fahad Alamoudi, Yaser Miaji, Fawzy Jalalah

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The growing popularity of swimming pools and other activities in the water for sport, fitness, therapy or just enjoyable relaxation have led to the increased use of swimming pools and the establishment of a variety of specific-use pools such as spa pools, Waterslides and more recently, hydrotherapy and wave pools. In this research a few simple equipments are used for test, Detect and alert for detection of water cleanness and pollution. YSI Photometer Systems, TDSTestr High model, rio 12HF, and Electrode A1. The researchers used electrolysis as a method of separating bonded elements and compounds by passing an electric current through them. The results which use 41 experiments show the higher the salt concentration, the more efficient the electrode and the smaller the gap between the plates and The lower the electrode voltage. Furthermore, it is proved that the larger the surface area, the lower the cell voltage and the higher current used the more chlorine produced.

Keywords: photometer, electrode, electrolysis, swimming pool chlorination

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Authors: Huang Wei-Yi

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Objective: This article explores the intensive care nursing experience of a lung cancer patient with pulmonary embolism who was placed on ECMO. Following a sudden change in the patient’s condition and a consensus reached during a family meeting, the decision was made to withdraw life-sustaining equipment and collaborate with the palliative care team. Methods: The nursing period was from October 20 to October 27, 2023. The author monitored physiological data, observed, provided direct care, conducted interviews, performed physical assessments, and reviewed medical records. Together with the critical care team and bypass personnel, a comprehensive assessment was conducted using Gordon's Eleven Functional Health Patterns to identify the patient’s health issues, which included pain related to lung cancer and invasive devices, fear of death due to sudden deterioration, and altered tissue perfusion related to hemodynamic instability. Results: The patient was admitted with fever, back pain, and painful urination. During hospitalization, the patient experienced sudden discomfort followed by cardiac arrest, requiring multiple CPR attempts and ECMO placement. A subsequent CT angiogram revealed a pulmonary embolism. The patient's condition was further complicated by severe pain due to compression fractures, and a diagnosis of terminal lung cancer was unexpectedly confirmed, leading to emotional distress and uncertainty about future treatment. Throughout the critical care process, ECMO was removed on October 24, stabilizing the patient’s body temperature between 36.5-37°C and maintaining a mean arterial pressure of 60-80 mmHg. Pain management, including Morphine 8mg in 0.9% N/S 100ml IV drip q6h PRN and Ultracet 37.5 mg/325 mg 1# PO q6h, kept the pain level below 3. The patient was transferred to the ward on October 27 and discharged home on October 30. Conclusion: During the care period, collaboration with the medical team and palliative care professionals was crucial. Adjustments to pain medication, symptom management, and lung cancer-targeted therapy improved the patient’s physical discomfort and pain levels. By applying the unique functions of nursing and the four principles of palliative care, positive encouragement was provided. Family members, along with social workers, clergy, psychologists, and nutritionists, participated in cross-disciplinary care, alleviating anxiety and fear. The consensus to withdraw ECMO and life-sustaining equipment enabled the patient and family to receive high-quality care and maintain autonomy in decision-making. A follow-up call on November 1 confirmed that the patient was emotionally stable, pain-free, and continuing with targeted lung cancer therapy.

Keywords: intensive care, lung cancer, pulmonary embolism, ECMO

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Authors: Mikhail S. Zastrozhin, Valery V. Smirnov, Dmitry A. Sychev, Ludmila M. Savchenko, Evgeny A. Bryun, Mark O. Nechaev

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Cytochrome P-450 isoenzyme 3A4 takes part in the biotransformation of medical drugs. The activity of CYP isoenzymes depends on genetic (polymorphisms of genes which encoded it) and phenotypic factors (a kind of food, a concomitant drug therapy). The aim of the study was to evaluate a carbamazepine effect on the CYP3A4 activity in patients with alcohol addiction. The study included 25 men with alcohol dependence, who received haloperidol during the exacerbation of the addiction. CYP3A4 activity was assessed by urinary 6-beta-hydroxycortisol/cortisol ratios measured by high performance liquid chromatography with mass spectrometry. The study modeled a graph and an equation of the logarithmic regression, that reflects the dependence of CYP3A4 activity on a dose of carbamazepine: y = 5,5 * 9,1 * 10-5 * x2. The study statistically significant demonstrates the effect of carbamazepine on CYP2D6 isozyme activity in patients with alcohol addiction.

Keywords: CYP3A4, biotransformation, carbamazepine, alcohol abuse

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Authors: Temesgen Geremew

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Functionalized nanoparticles have emerged as a revolutionary class of materials with immense potential in various biomedical applications. These engineered nanoparticles possess unique properties tailored to interact with biological systems, offering unprecedented opportunities in drug delivery, imaging, diagnostics, and therapy. This research delves into the design, synthesis, and characterization of functionalized nanoparticles for targeted biomedical applications. The primary focus lies on developing nanoparticles with precisely controlled size, surface chemistry, and biocompatibility for specific medical purposes. The research will also explore the crucial interaction of these nanoparticles with biological systems, encompassing cellular uptake, biodistribution, and potential toxicity evaluation. The successful development of functionalized nanoparticles holds the promise to revolutionize various aspects of healthcare. This research aspires to contribute significantly to this advancement by providing valuable insights into the design and application of these versatile materials within the ever-evolving field of biomedicine.

Keywords: nanoparticles, biomedicals, cancer, biocompatibility

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Authors: Anastasia Papachristou, Anastasia Ntikoudi, Vasileios Saridakis

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The safety and health care needs of refugees have become an increasingly important issue all over the world especially during last few decades. Wars are the primary reason for refugees to leave their countries. Moreover, refugees are frequently exposed to a variety of stressors such as socioeconomic disadvantages, poverty, changes in family structure and functioning, losing social support, difficulty to access education, living in very crowded places, experiencing racism and isolation. This systematic review included research studies published between 2007-2017 from the search databases Medline, Scopus, Cinahl and PubMed, with keywords 'war survivors', 'war trauma', 'psychiatric disorders', 'refugees'. In order to meet the purpose of the systematic review, further research for complementary studies was conducted into the literature references of the research articles included in this study that would meet the criteria. Overall, 14 studies were reviewed and evaluated. The majority of them demonstrated that the most common psychiatric disorders observed among war refugees are post-traumatic stress disorder (PTSD), depression, anxiety and multiple somatic complaints. Moreover, significant relationship was shown between the number of traumatic events experienced by the refugees and sociodemographic features such as gender, age and previous family history of any psychological disorder. War violence is highly traumatic, causing multiple, long-term negative outcomes such as the aforementioned psychiatric disorders. The number of the studies reviewed in this systematic review is not representative of the problem and its significance. The need for care of the survivors and their families is vital. Further research is necessary in order to clarify the role of predictive factors in the development and maintenance of post-traumatic stress and the rest psychiatric disorders following war trauma. In conclusion, it is necessary to have large multicenter studies in the future in order to be able to draw reliable conclusions about the effects of war.

Keywords: psychiatric disorders, refugees, war survivors, war trauma

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Authors: Harveen Kaur Tatla, Parisa Niknejad, Rajender Gupta, Bipro Ranjan Dhar, Mohd. Adana Khan

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Sewage sludge management presents a pressing challenge in the realm of wastewater treatment, calling for sustainable and efficient solutions. This study explores the integration of Hydrothermal Liquefaction (HTL) and Anaerobic Digestion (AD) as a promising approach to address the complexities associated with sewage sludge treatment. The integration of these two processes offers a complementary and synergistic framework, allowing for the mitigation of inherent limitations, thereby enhancing overall efficiency, product quality, and the comprehensive utilization of sewage sludge. In this research, we investigate the optimal sequencing of HTL and AD within the treatment framework, aiming to discern which sequence, whether HTL followed by AD or AD followed by HTL, yields superior results. We explore a range of HTL working temperatures, including 250°C, 300°C, and 350°C, coupled with residence times of 30 and 60 minutes. To evaluate the effectiveness of each sequence, a battery of tests is conducted on the resultant products, encompassing Total Ammonia Nitrogen (TAN), Chemical Oxygen Demand (COD), and Volatile Fatty Acids (VFA). Additionally, elemental analysis is employed to determine which sequence maximizes energy recovery. Our findings illuminate the intricate dynamics of HTL and AD integration for sewage sludge management, shedding light on the temperature-residence time interplay and its impact on treatment efficiency. This study not only contributes to the optimization of sewage sludge treatment but also underscores the potential of integrated processes in sustainable waste management strategies. The insights gleaned from this research hold promise for advancing the field of wastewater treatment and resource recovery, addressing critical environmental and energy challenges.

Keywords: Anaerobic Digestion (AD), aqueous phase, energy recovery, Hydrothermal Liquefaction (HTL), sewage sludge management, sustainability.

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Authors: Premalatha B. S., Shenoy A. M.

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Background: Rehabilitation of swallowing is as vital as speech in surgically treated head and neck cancer patients to maintain nutritional support, enhance wound healing and improve quality of life. Aspiration following supraglottic laryngectomy is very common, and rehabilitation of the same is crucial which requires involvement of speech therapist in close contact with head and neck surgeon. Objectives: To examine the functions of swallowing outcomes after intensive therapy in supraglottic laryngectomy. Materials: Thirty-nine supra glottic laryngectomees were participated in the study. Of them, 36 subjects were males and 3 were females, in the age range of 32-68 years. Eighteen subjects had undergone standard supra glottis laryngectomy (Group1) for supraglottic lesions where as 21 of them for extended supraglottic laryngectomy (Group 2) for base tongue and lateral pharyngeal wall lesion. Prior to surgery visit by speech pathologist was mandatory to assess the sutability for surgery and rehabilitation. Dysphagia rehabilitation started after decannulation of tracheostoma by focusing on orientation about anatomy, physiological variation before and after surgery, which was tailor made for each individual based on their type and extent of surgery. Supraglottic diet - Soft solid with supraglottic swallow method was advocated to prevent aspiration. The success of intervention was documented as number of sessions taken to swallow different food consistency and also percentage of subjects who achieved satisfactory swallow in terms of number of weeks in both the groups. Results: Statistical data was computed in two ways in both the groups 1) to calculate percentage (%) of subjects who swallowed satisfactorily in the time frame of less than 3 weeks to more than 6 weeks, 2) number of sessions taken to swallow without aspiration as far as food consistency was concerned. The study indicated that in group 1 subjects of standard supraglottic laryngectomy, 61% (n=11) of them were successfully rehabilitated but their swallowing normalcy was delayed by an average 29th post operative day (3-6 weeks). Thirty three percentages (33%) (n=6) of the subjects could swallow satisfactorily without aspiration even before 3 weeks and only 5 % (n=1) of the needed more than 6 weeks to achieve normal swallowing ability. Group 2 subjects of extended SGL only 47 %( n=10) of them could achieved satisfactory swallow by 3-6 weeks and 24% (n=5) of them of them achieved normal swallowing ability before 3 weeks. Around 4% (n=1) needed more than 6 weeks and as high as 24 % (n=5) of them continued to be supplemented with naso gastric feeding even after 8-10 months post operative as they exhibited severe aspiration. As far as type of food consistencies were concerned group 1 subject could able to swallow all types without aspiration much earlier than group 2 subjects. Group 1 needed only 8 swallowing therapy sessions for thickened soft solid and 15 sessions for liquids whereas group 2 required 14 sessions for soft solid and 17 sessions for liquids to achieve swallowing normalcy without aspiration. Conclusion: The study highlights the importance of dysphagia intervention in supraglottic laryngectomees by speech pathologist.

Keywords: dysphagia management, supraglotic diet, supraglottic laryngectomy, supraglottic swallow

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Authors: Catarina Belchior, Catarina Martins, Sara Mendes, Ana Rita S. Valente, Elsa Marta Soares

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Introduction: The negative feelings and attitudes that a person who stutters can develop are extremely relevant when considering assessment and intervention in Speech and Language Therapy. This relates to the fact that the person who stutters can experience feelings such as shame, fear and negative beliefs when communicating. Considering the complexity and importance of integrating diverse aspects in stuttering intervention, it is central to identify those emotions as early as possible. Therefore, this research aimed to achieve the translation, adaptation to European Portuguese and to analyze the content validation of the Preschooler Awareness Stuttering Survey (Abbiati, Guitar & Hutchins, 2015), an instrument that allows the assessment of the impact of stuttering on preschool children who stutter considering feelings and attitudes. Methodology: Cross-sectional descriptive qualitative research. The following methodological procedures were followed: translation, back-translation, panel of experts and pilot study. This abstract describes the results of the first three phases of this process. The translation was accomplished by two Speech Language Therapists (SLT). Both professionals have more than five years of experience and are users of English language. One of them has a broad experience in the field of stuttering. Back-translation was conducted by two bilingual individuals without experience in health or any knowledge about the instrument. The panel of experts was composed by 3 different SLT, experts in the field of stuttering. Results and Discussion: In the translation and back-translation process it was possible to verify differences in semantic and idiomatic equivalences of several concepts and expressions, as well as the need to include new information to enhance the understanding of the application of the instrument. The meeting between the two translators and the researchers allowed the achievement of a consensus version that was used in back-translation. Considering adaptation and content validation, the main change made by the experts was the conceptual equivalence of the questions and answers of the instrument's sheets. Considering that in the translated consensus version the questions began with various nouns such as 'is' or 'the cow' and that the answers did not contain the adverb 'much' as in the original instrument, the panel agreed that it would be more appropriate if the questions all started with 'how' and that all the answers should present the adverb 'much'. This decision was made to ensure that the translate instrument would be similar to the original and so that the results obtained could be comparable between the original and the translated instrument. There was also elaborated one semantic equivalence between concepts. The panel of experts found that all other items and specificities of the instrument were adequate, concluding the adequacy of the instrument considering its objectives and its intended target population. Conclusion: This research aspires to diversify the existing validated resources in this scope, adding a new instrument that allows the assessment of preschool children who stutter. Consequently, it is hoped that this instrument will provide a real and reliable assessment that can lead to an appropriate therapeutic intervention according to the characteristics and needs of each child.

Keywords: stuttering, assessment, feelings and attitudes, speech language therapy

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Authors: Ana Lucia Molina

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Introduction: Fine motor skills refer to the use of the hands and coordination of the small muscles that control the fingers. A deficiency in fine motor skills is as important as a change in global movements, as fine motor skills directly affect activities of daily living. Fine movements are involved in some functions, such as motor control of the extremities, sensitivity, strength and tonus of the hands. A growing interest in the effects of non-invasive neuromodulation, such as transcranial stimulation technologies, through transcranial magnetic stimulation (TMS), has been observed in the scientific literature, with promising results in fine motor rehabilitation, as it provides modulation of the corresponding cortical activity in the area primary motor skills of the hands in both hemispheres (according to the International System 10-20, corresponding to C3 and C4). Objectives: to carry out a literature review about the effects of TMS on the cortical motor area corresponding to hand motricity. Methodology: This is a bibliographic survey carried out between October 2022 and March 2023 at Pubmed, Google Scholar, Lillacs and Virtual Health Library (BVS), with a national and international database. Some books on neuromodulation were included. Results: 28 articles and 5 books were initially found, and after reading the abstracts, only 14 articles and 3 books were selected, with publication dates between 2008 and 2022, to compose the literature review since it suited the purpose of this study. Conclusion: TMS has shown promising results in the treatment of fine motor rehabilitation, such as improving coordination, muscle strength and range of motion of the hands, being a complementary technique to existing treatments and thus providing more potent results for manual skills in activities of daily living. It is important to emphasize the need for more specific studies on the application of TMS for the treatment of manual disorders, which describe the uniqueness of each movement.

Keywords: transcranial magnetic stimulation, fine motor skills, motor rehabilitation, non-invasive neuromodulation

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Authors: Krzysztof Plesiewicz, Izabela Plesiewicz, Krzysztof Chiżyński, Marzenna Zielińska

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Background: Obesity is an independent risk factor for cardiovascular diseases. There are several anthropometric parameters proposed to estimate the level of obesity, but until now there is no agreement which one is the best predictor of cardiometabolic risk. Scientists defined metabolically obese normal weight, who suffer from metabolic abnormalities, the same as obese individuals, and defined this syndrome as normal weight obesity (NWO). Aim of the study: The aim of our study was to determine the occurrence of overweight and obesity in a cohort of young, adult women, using standard and complementary methods of obesity assessment and to indicate those, who are at risk of obesity. The second aim of our study was to test additional methods of obesity assessment and proof that body mass index using alone is not sufficient parameter of obesity assessment. Materials and methods: 384 young women, aged 18-32, were enrolled into the study. Standard anthropometric parameters (waist to hips ratio (WTH), waist to height ratio (WTHR)) and two other methods of body fat percentage measurement (BFPM) were used in the study: electrical bioimpendance analysis (BIA) and skinfold measurement test by digital fat body mass clipper (SFM). Results: In the study group 5% and 7% of participants had waist to hips ratio and accordingly waist to height ratio values connected with visceral obesity. According to BMI 14% participants were overweight and obese. Using additional methods of body fat assessment, there were 54% and 43% of obese for BIA and SMF method. In the group of participants with normal BMI and underweight (not overweight, n =340) there were individuals with the level of BFPM above the upper limit, for the BIA 49% (n =164) and for the SFM 36 % (n=125). Statistical analysis revealed strong correlation between BIA and SFM methods. Conclusion: BMI using alone is not a sufficient parameter of obesity assessment. High percentage of young women with normal BMI values seem to be normal weight obese.

Keywords: electrical bioimpedance, normal weight obesity, skin-fold measurement test, women

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Authors: Yohanes Kambaru Windi, Loetfia Dwi Rahariyani, Dyah Wijayanti, Eko Rustamaji

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Surabaya, the second largest city in Indonesia, has been struggling for years with waste production and its management. Nearly 11,000 tons of waste are generated daily by domestic, commercial and industrial areas. It is predicted that approximately 1,300 tons of waste overflew the Benowo Landfill daily in 2013 and projected that the landfill operation will be critical in 2015. The Super Depo Sutorejo (SDS) is a pilot project on waste management launched by the government of Surabaya in March 2013. The project is aimed to reduce the amount of waste dumped in landfill by sorting the recyclable and organic waste for composting by employing waste pickers to sort the waste before transported to landfill. This study is intended to assess the capacity of SDS to process and reduce waste and its complementary benefits. It also overviews the benefits of the project to the waste pickers in term of satisfaction to the job. Waste processing data-sheets were used to assess the difference between input and outputs waste. A survey was distributed to 30 waste pickers and interviews were conducted as a further insight on a particular issue. The analysis showed that SDS enable to reduce waste up to 50% before dumped in the final disposal area. The cost-benefits analysis using cost differential calculation revealed the economic benefit is considerable low, but composting may substitute tangible benefits for maintain the city’s parks. Waste pickers are mostly satisfied with their job (i.e. Salary, health coverage, job security), services and facilities available in SDS and enjoyed rewarding social life within the project. It is concluded that SDS is an effective and efficient model for sustainable waste management and reliable to be developed in developing countries. It is a strategic approach to empower and open up working opportunity for the poor urban community and prolong the operation of landfills.

Keywords: cost-benefits, integration, satisfaction, waste management

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Authors: Chettyparambil Lalchand Thejalakshmi, Sonal Sabu Edattukaran

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Hair loss is one of the main issues that contemporary society is dealing with. It can be attributable to a wide range of factors, listing from one's genetic composition and the anxiety we experience on a daily basis. Telogen effluvium [TE] is a condition that causes temporary hair loss after a stressor that might shock the body and cause the hair follicles to temporarily rest, leading to hair loss. Most frequently, women are the ones who bring up these difficulties. Extreme illness or trauma, an emotional or important life event, rapid weight loss and crash dieting, a severe scalp skin problem, a new medication, or ceasing hormone therapy are examples of potential causes. Men frequently do not notice hair thinning with time, but women with long hair may be easily identified when shedding, which can occasionally result in bias because women tend to be more concerned with aesthetics and beauty standards of the society, and approach frequently with the concerns .The woman, who formerly possessed a full head of hair, is worried about the hair loss from her scalp . There are several cases of hair loss reported every day, and Telogen effluvium is said to be the most prevalent one of them all without any hereditary risk factors. While the patient has loss in hair volume, baldness is not the result of this problem . The exponentially growing Dermatology and Aesthetic medical division has discovered that this problem is the most common and also the easiest to cure since it is feasible for these people to regrow their hair, unlike those who have scarring alopecia, in which the follicle itself is damaged and non-viable. Telogen effluvium comes in two different forms: acute and chronic. Acute TE occurs in all the age groups with a hair loss of less than three months, while chronic TE is more common in those between the ages of 30 and 60 with a hair loss of more than six months . Both kinds are prevalent throughout all age groups, regardless of the predominance. It takes between three and six months for the lost hair to come back, although this condition is readily reversed by eliminating stresses. After shedding their hair, patients frequently describe having noticeable fringes on their forehead. The current medical treatments for this condition include topical corticosteroids, systemic corticosteroids, minoxidil and finasteride, CNDPA (caffeine, niacinamide, panthenol, dimethicone, and an acrylate polymer) .Individual terminal hair growth was increased by 10% as a result of the innovative intervention CNDPA. Botulinum Toxin A, Scalp Micro Needling, Platelet Rich Plasma Therapy [PRP], and sessions with Multivitamin Mesotherapy Injections are some recently enhanced techniques with partially or completely reversible hair loss. Also, it has been shown that supplements like Nutrafol and Biotin are producing effective outcomes. There is virtually little evidence to support the claim that applying sulfur-rich ingredients to the scalp, such as onion juice, can help TE patients' hair regenerate.

Keywords: dermatology, telogen effluvium, hair loss, modern hair loass treatments

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Authors: Vartan Agopian

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Millions of Syrian families have been displaced since the beginning of the Syrian war, and the negative effects of post-war trauma have shown detrimental effects on the mental health of refugee children. While educational strategies have focused on vocational training and academic achievement, little has been done to include music in the school curriculum to help these children improve their mental health. The literature of music education and psychology, on the other hand, shows the positive effects of music on traumatized children, especially when it comes to dealing with stress. This paper presents a brief literature review of trauma, music therapy, and music in the classroom, after having introduced the Syrian war and refugee situation. Furthermore, the paper highlights the benefits of using music with traumatized children from the literature and offers strategies for teachers (such as singing, playing an instrument, songwriting, and others) to include music in their classrooms to help Syrian refugee children deal with post-war trauma.

Keywords: children, music, refugees, Syria, war

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Authors: Dawit Thomas

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Feeding and weaning practices vary from culture to culture and depend on different child-rearing values. The socio-cultural dimensions that influence the acceptable infant feeding practices are varied and complex. Understanding cultural differences in beliefs and practices relating to infant feeding is important to enhance designing programs for delivering successful psychological, social, physiological and economic well-being of mothers and infants. The main purpose of this study was exploring mothers infant feeding practices in the context of Hadiyya culture. After purposively selecting Harche Huyaya Uyaya Kebele eight infant feeding mothers were selected using snowball sampling technique. The study employed interviews and focus group discussion. The study found out early initiation and prolonged breastfeeding and early complementary feeding in some instances immediately after birth. In addition, infants were not forced to wean unless the mothers encounter pressing issues like pregnancy and health related problems. Furthermore, the main weaning techniques were putting unpleasant materials on the tip of nipples and sending infants to grandparents home. The study also found out gender difference in weaning, i.e., early initiation of weaning for girls. This can be indicative of gender-based bias on weaning practice. Finally, health extension workers, office of women and children affairs and Hadiyya Zone Tourism office should organize awareness raising programs to preserve vital infant feeding practices like prolonged breastfeeding and length of weaning. In addition, the offices should raise awareness among communities on negative side effects of sending infant to grandparents home that may weaken infant-mothers attachment and create favorable ground for the development of phobia.

Keywords: feeding, infant, practices, weaning

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Authors: Roger-Claude Liwanga

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This article reflects on the normative aspects of the jurisprudence on the protection of human rights in times of war that the International Court of Justice (ICJ) developed in 2005 in the Case Concerning Armed Activities on the Territory of the Congo (Democratic Republic of Congo v. Uganda). The article focuses on theories raised in connection with the Democratic Republic of Congo (DRC)'s claim of the violation of human rights of its populations by Uganda as opposed to the violation of its territorial integrity claims. The article begins with a re-visitation of the doctrine of state extraterritorial responsibility for violations of human rights by suggesting that a state's accountability for the breach of its international obligations is not territorially confined but rather transcends the State's national borders. The article highlights the criteria of assessing the State's extraterritorial responsibility, including the circumstances: (1) where the concerned State has effective control over the territory of another State in the context of belligerent occupation, and (2) when the unlawful actions committed by the State's organs on the occupied territory can be attributable to that State. The article also analyzes the ICJ's opinions articulated in DRC v. Uganda with reference to the relationship between human rights law and humanitarian law, and it contends that the ICJ had revised the traditional interaction between these two bodies of law to the extent that human rights law can no longer be excluded from applying in times of war as both branches are complementary rather than exclusive. The article correspondingly looks at the issue of reparations for victims of human rights violations. It posits that reparations for victims of human rights violations should be integral (including restitution, compensation, rehabilitation, satisfaction, and guarantees of non-repetition). Yet, the article concludes by emphasizing that reparations for victims were not integral in DRC v. Uganda because: (1) the ICJ failed to set a reasonable timeframe for the negotiations between the DRC and Uganda on the amount of compensation, resulting in Uganda paying no financial reparation to the DRC since 2005; and (2) the ICJ did not request Uganda to domestically prosecute the perpetrators of human rights abuses.

Keywords: human rights law, humanitarian law, civilian protection, extraterritorial responsibility

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Authors: Kylie Mueller, Nijole Bernaitis, Shailendra Anoopkumar-Dukie

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Background: Vitamin K antagonists particularly warfarin is the most frequently used oral medication for deep vein thrombosis (DVT) treatment and prophylaxis. Time in therapeutic range (TITR) of the international normalised ratio (INR) is widely accepted as a measure to assess the quality of warfarin therapy. Multiple factors can affect warfarin control and the subsequent adverse outcomes including thromboembolic and bleeding events. Predictor models have been developed to assess potential contributing factors and measure the individual risk of these adverse events. These predictive models have been validated in atrial fibrillation (AF) patients, however, there is a lack of literature on whether these can be successfully applied to other warfarin users including DVT patients. Therefore, the aim of the study was to assess the ability of these risk models (HAS BLED and CHADS2) to predict haemorrhagic and ischaemic incidences in DVT patients treated with warfarin. Methods: A retrospective analysis of DVT patients receiving warfarin management by a private pathology clinic was conducted. Data was collected from November 2007 to September 2014 and included demographics, medical and drug history, INR targets and test results. Patients receiving continuous warfarin therapy with an INR reference range between 2.0 and 3.0 were included in the study with mean TITR calculated using the Rosendaal method. Bleeding and thromboembolic events were recorded and reported as incidences per patient. The haemorrhagic risk model HAS BLED and ischaemic risk model CHADS2 were applied to the data. Patients were then stratified into either the low, moderate, or high-risk categories. The analysis was conducted to determine if a correlation existed between risk assessment tool and patient outcomes. Data was analysed using GraphPad Instat Version 3 with a p value of <0.05 considered to be statistically significant. Patient characteristics were reported as mean and standard deviation for continuous data and categorical data reported as number and percentage. Results: Of the 533 patients included in the study, there were 268 (50.2%) female and 265 (49.8%) male patients with a mean age of 62.5 years (±16.4). The overall mean TITR was 78.3% (±12.7) with an overall haemorrhagic incidence of 0.41 events per patient. For the HAS BLED model, there was a haemorrhagic incidence of 0.08, 0.53, and 0.54 per patient in the low, moderate and high-risk categories respectively showing a statistically significant increase in incidence with increasing risk category. The CHADS2 model showed an increase in ischaemic events according to risk category with no ischaemic events in the low category, and an ischaemic incidence of 0.03 in the moderate category and 0.47 high-risk categories. Conclusion: An increasing haemorrhagic incidence correlated to an increase in the HAS BLED risk score in DVT patients treated with warfarin. Furthermore, a greater incidence of ischaemic events occurred in patients with an increase in CHADS2 category. In an Australian population of DVT patients, the HAS BLED and CHADS2 accurately predicts incidences of haemorrhage and ischaemic events respectively.

Keywords: anticoagulant agent, deep vein thrombosis, risk assessment, warfarin

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Authors: Seyedeh Faranak Baniahmad, Soroor Yousefi

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Osteoporosis is a bone disease which increases the bone fracture risk, reduces the bone mineral density (BMD) and alters the amount and variety of proteins in bones. Antiresorptive therapy is one the most popular Osteoporosis treatment methods. In this method the bisphosphonates, hormones, calcitonin or the selective estrogen receptor modulators is replaced. In order to reduce undesirable effects and to increase the bioavailability of drug agents, the controlled drug delivery systems have been utilized. In current study, the controlled release of Alendronate from LDH-PCL with (0, 5, 10, 15 % wt. of LDH) was investigated. The results showed that the release of alendronate from the lamellar LDH incorporated into the PCL matrix is much slower than the release of alendronate from the PCL. Therefore such systems are very promising, in which the antiresorptive drug has to remain in the matrix for longer time and can be released in controlled manner.

Keywords: osteoporosis, alendronate, poly (ε–caprolactone), layered double hydroxide

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Authors: Sharon Waichman, Shahaf Froim, Ido Zukerman, Shmuel Barzilai, Shmual Hayun, Avi Raveh

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Boron carbide is a ceramic material with superior properties such as high chemical and thermal stability, high hardness and high wear resistance. Moreover, it has a big cross section for neutron absorption and therefore can be employed in nuclear based applications. However, an efficient attachment of boron carbide to a metal such as aluminum can be very challenging, mainly because of the formation of aluminum-carbon bonds that are unstable in humid environment, the affinity of oxygen to the metal and the different thermal expansion coefficients of the two materials that may cause internal stresses and a subsequent failure of the bond. Here, we aimed to achieving a strong and a durable attachment between the boron carbide coating and the aluminum substrate. For this purpose, we applied Ti as a thin intermediate layer that provides a gradual change in the thermal expansion coefficients of the configured layers. This layer is continuous and therefore prevents the formation of aluminum-carbon bonds. Boron carbide coatings with a thickness of 1-5 µm were deposited on the aluminum substrate by pulse-DC magnetron sputtering. Prior to the deposition of the boron carbide layer, the surface was pretreated by energetic ion plasma followed by deposition of the Ti intermediate adhesive layer in a continuous process. The properties of the Ti intermediate layer were adjusted by the bias applied to the substrate. The boron carbide/aluminum bond was evaluated by various methods and complementary techniques, such as SEM/EDS, XRD, XPS, FTIR spectroscopy and Glow Discharge Spectroscopy (GDS), in order to explore the structure, composition and the properties of the layers and to study the adherence mechanism of the boron carbide/aluminum contact. Based on the interfacial bond characteristics, we propose a desirable solution for improved adhesion of boron carbide to aluminum using a highly efficient intermediate adhesive layer.

Keywords: adhesion, boron carbide coatings, ceramic/metal bond, intermediate layer, pulsed-DC magnetron sputtering

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Authors: Rongrong Liu, Li Wang, Hui Xu, Jianpei Fang, Sixi Liu, Xiaolin Yin, Junbin Liang, Gaohui Yan, Yaoyun Li, Yali Zhou, Xinyu Li, Yue Li, Lei Shi, Yongrong Lai, Junjiu Huang, Xinhua Zhang

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Background: Beta-Thalassemia is caused by reduced (β+) or absent (β0) synthesis of the β-globin chains of hemoglobin. Transfusions and oral iron chelation therapy have improved the quality of life for patients with Transfusion-Dependent thalassemia (TDT). Recent advances in genome editing platforms of CRISPR-Cas9 have paved the way for induction of HbF by reactivating expression of γ-chain.Aims: We performed CRISPR-Cas9-mediated genome editing of hematopoietic stem cells to mutate HBG1/HBG2 promoter sequence, thereby representing a naturally occurring HPFH-liked mutation, producing RM-001. Here, we present an initial assessment of safety and efficacy of RM-001 in patients with TDT. Methods: Patients (6–35 y of age) with TDT receiving packed red blood cell (pRBC) transfusions of ≥100 mL/kg/y or ≥10 units/y in the previous 2 y were eligible. CD34+ cells were edited with CRISPR-Cas9 using a guide RNA specific for the binding site of BCL11A on the HBG1/2 promoter. Prior to RM-001 product infusion (day 0), patients received myeloablative conditioning with Busulfan from day-7 to day-4. Patients were monitored for AEs Hb expression.Results: Data cut as of 28 Feb 2024, 16 TDT patients have been treated with RM-001 and followed ≥3 months. 5 of these 16 patients had finished their 24 months follow up. Eleven patients have β0/β0 genotype and five patients have β0/β+ genotype. In addition to β-thalassemia, two patients had α- deletion with the genotype of --/αα. Efficacy:All patients received a single dose intravenous infusion of RM-001 cells. 5 of them had been followed 24 months or longer. All patients achieved transfusion-independent (TI, total Hb continued ≥ 9g/dL) (Figure1). Patients demonstrated sustained and clinically meaningful increases in HbF levels since 4 month post-RM-001 infusion (Figure.2). Total hemoglobin in all patients was stable at 10-12g/dL during the follow-up period. Safety:The adverse events observed after RM-001 infusion were consistent with those that are typical of Busulfan-based myeloablation. The allelic editing analysis at 6-month visit showed that the on-target allelic editing frequency in bone marrow cells was 73.44% (64.65% to 84.6%, n=13).Summary/Conclusion: This interim analysis, in which all the 19 patients age from 7.9 to 25yo met the success criteria for the trial with respect to transfusion independence, showed that autologous HBG1/2 promoter-modified CD34+ HSPCs gene therapy resulted in an adequate amount of HbF as early as 2 months after infusion led to near-normal hemoglobin levels, remained transfusion-free through the reported period without product related SAE. After RM-001 infusion, high levels of HbF proportion and on-target editing in bone marrow cells were maintained. Submitted on behalf of the RM-001 Investigators.

Keywords: thalassemian, genetherapy, CRISPR/Cas9, HbF

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