Search results for: clinical trial optimization

Authors: Mojtaba Barzegar, Alireza Shirazi, Saied Rabi Mahdavi

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Intraoperative radiation therapy (IORT) is an innovative treatment modality that the delivery of a large single dose of radiation to the tumor bed during the surgery. The radiotherapy success depends on the absorbed dose delivered to the tumor. The achievement better accuracy in patient treatment depends upon the measured dose by standard dosimeter such as ionization chamber, but because of the high density of electric charge/pulse produced by the accelerator in the ionization chamber volume, the standard correction factor for ion recombination Ksat calculated with the classic two-voltage method is overestimated so the use of dose/pulse independent dosimeters such as chemical Fricke and ethanol chlorobenzene (ECB) dosimeters have been suggested. Dose measurement is usually calculated and calibrated in the Zmax. Ksat calculated by comparison of ion chamber response and ECB dosimeter at each applicator degree, size, and dose. The relative output factors for IORT applicators have been calculated and compared with experimentally determined values and the results simulated by Monte Carlo software. The absorbed doses have been calculated and measured with statistical uncertainties less than 0.7% and 2.5% consecutively. The relative differences between calculated and measured OF’s were up to 2.5%, for major OF’s the agreement was better. In these conditions, together with the relative absorbed dose calculations, the OF’s could be considered as an indication that the IORT electron beams have been well simulated. These investigations demonstrate the utility of the full Monte Carlo simulation of accelerator head with ECB dosimeter allow us to obtain detailed information of clinical IORT beams.

Keywords: intra operative radiotherapy, ethanol chlorobenzene, ksat, output factor, monte carlo simulation

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Authors: Lelika Lazarus, Reshma Sookrajh, Kapil S. Satyapal

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Reflecting on teaching is commonly cited as a fundamental practice for personal and professional development. Educational research into the scholarship of teaching and learning anatomy includes engaging in discipline specific literature on teaching, reflecting on individual teaching methods and communicating these findings to peers. The aim of this paper is to formally assess the opinions of senior anatomy instructors regarding the state of anatomical knowledge at their respective institutions. The context of the paper derives from ongoing debates about the perceived decline in standards of anatomical knowledge of medical students and postgraduate learners. An open ended questionnaire was devised consisting of eight direct questions seeking opinions on anatomy teaching, knowledge, and potential educational developments and general thoughts on the teaching of anatomy to medical students. These were distributed to senior anatomy Faculty (identified by the author by their affiliation with the Anatomical Society of Southern Africa) based at the eight national medical schools within the country. A number of key themes emerged. Most senior faculty felt that the standard of medical education at their respective institutions was ‘good.’. However, emphasis was also placed on the ‘quality of teaching’ incorporating clinical scenarios. There were also indications that staff are split into those that are keen to do research and those that are happy to provide teaching to medical students as their primary function. Several challenges were also highlighted such as time constraints within the medical curriculum, the lack of cadavers to reinforce knowledge and gain depth perception and lack of appropriately qualified staff. Recommendations included fostering partnerships with both clinicians and medical scientists into the anatomy curriculum thus improving teaching and research.

Keywords: anatomy, education, reflection, teaching

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Authors: Neha Singh, Shristi Singh

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Accidents involving motor vehicles are more likely to cause serious injuries and fatalities. It also has a host of other perpetual issues, such as the regular loss of life and goods in accidents. To solve these issues, appropriate measures must be implemented, such as establishing an autonomous incident detection system that makes use of machine learning and artificial intelligence. In order to reduce traffic accidents, this article examines the overview of artificial intelligence and machine learning in autonomous event detection systems. The paper explores the major issues, prospective solutions, and use of artificial intelligence and machine learning in road transportation systems for minimising traffic accidents. There is a lot of discussion on additional, fresh, and developing approaches that less frequent accidents in the transportation industry. The study structured the following subtopics specifically: traffic management using machine learning and artificial intelligence and an incident detector with these two technologies. The internet of vehicles and vehicle ad hoc networks, as well as the use of wireless communication technologies like 5G wireless networks and the use of machine learning and artificial intelligence for the planning of road transportation systems, are elaborated. In addition, safety is the primary concern of road transportation. Route optimization, cargo volume forecasting, predictive fleet maintenance, real-time vehicle tracking, and traffic management, according to the review's key conclusions, are essential for ensuring the safety of road transportation networks. In addition to highlighting research trends, unanswered problems, and key research conclusions, the study also discusses the difficulties in applying artificial intelligence to road transport systems. Planning and managing the road transportation system might use the work as a resource.

Keywords: artificial intelligence, machine learning, incident detector, road transport systems, traffic management, automatic incident detection, deep learning

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Authors: Anna Słupik, Patryk Wąsowski, Anna Mosiołek, Dariusz Białoszewski

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Introduction: Kinesiology Taping is one of the most popular techniques used for treatment and supporting physiological processes in sports medicine and physiotherapy. Often it is used to sensorimotor skills of lower limbs by athletes. The aim of the study was to determine the effect of the application of muscle Kinesiology Taping to feel the position setting in motion the joint active. Material and methods: The study involved 50 healthy people between 18 and 30 years of age, 30 men and 20 women (mean age 23.24 years). The participants were divided into two groups. The study group was qualified for Kinesiology Taping application (muscle application, type Y, for quadriceps femoris muscle), while the remaining people used the application made of plaster (placebo group). Testing was performed prior to applying taping, with the applied application (after 30 minutes), then 24 hours after wearing, and after removing the tape. Each evaluated joint position sense - Error of Active Reproduction of Joint Position. Results: The survey revealed no significant differences in measurement between the study group and the placebo group (p> 0.05). No significant differences in time taking into account all four measurements in the group with the applied CT application, which was supported by pairs (p> 0.05). Also in the placebo group showed no significant differences over time (p> 0.05). There was no significant difference between the errors committed in the direction of flexion and extension. Conclusions: 1. Application muscle Kinesiology Taping had no significant effect on the knee joint proprioception. Its use in order to improve sensorimotor seems therefore unjustified. 2. There are no differences between applications Kinesiology Taping and placebo indicates that the clinical effect of stretch tape is minimal or absent. 3. The results are the basis for the continuation of prospective, randomized trials of numerous and study group.

Keywords: joint position sense, kinesiology taping, knee joint, proprioception

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Authors: Nigar Sultanova

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Facial morphology is a constant topic of concern for clinicians. When anthropometric methods were introduced into clinical practice to quantify changes in the craniofacial framework, features distinguishing various ethnic group were discovered. Normative data of facial measurements are indispensable to precise determination of the degree of deviations from normal. Establish the reference range of facial proportions in Azerbaijan population by anthropometric measurements of craniofacial complex. The study group consisted of 350 healthy young subjects, 175 males and 175 females, 18 to 25 years of age, from 7 different regions of Azerbaijan. The anthropometric examination was performed according to L.Farkas's method with our modification. In order to determine the morphologic characteristics of seven regions of the craniofacial complex 42 anthropometric measurements were selected. The anthropometric examination. Included the usage of 33 anthropometric landmarks. The 80 indices of the facial proportions, suggested by Farkas and Munro, were calculated: head -10, face - 23, nose - 23, lips - 9, orbits - 11, ears - 4. The date base of the North American white population was used as a reference group. Anthropometric measurements of facial proportions in Azerbaijan population revealed a significant difference between mеn and womеn, according to sexual dimorphism. In comparison with North American whites, considerable differences of facial proportions were observed in the head, face, orbits, labio-oral, nose and ear region. However, in women of the Azerbaijani population, 29 out of 80 proportion indices were similar to the proportions of NAW women. In the men of the Azerbaijani population, 27 out of 80 proportion indices did not reveal a statistically significant difference from the proportions of NAW men. Estimation of the reference range of facial proportions in Azerbaijan population migth be helpful to formulate surgical plan in treatment of congenital or post-traumatic facial deformities successfully.

Keywords: facial morphology, anthropometry, indices of proportion, measurement

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Authors: Efri Mardawati, Ronny Purwadi, Made Tri Ari Penia Kresnowati, Tjandra Setiadi

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EFB are mainly composed of cellulose (≈ 43%), hemicellulose (≈ 23%) and lignin (≈20%). The palm oil empty fruit bunches (EFB) is the lignosellulosic waste from crude palm oil industries mainly compose of (≈ 43%), hemicellulose (≈ 23%) and lignin (≈20%). Xylan, a polymer made of pentose sugar xylose and the most abundant component of hemicellulose in plant cell wall. Further xylose can be used as a raw material for production of a wide variety of chemicals such as xylitol, which is extensively used in food, pharmaceutical and thin coating applications. Currently, xylose is mostly produced from xylan via chemical hydrolysis processes. However, these processes are normally conducted at a high temperature and pressure, which is costly, and the required downstream processes are relatively complex. As an alternative method, enzymatic hydrolysis of xylan to xylose offers an environmentally friendly biotechnological process, which is performed at ambient temperature and pressure with high specificity and at low cost. This process is catalysed by xylanolytic enzymes that can be produced by some fungal species such as Aspergillus niger, Penicillium crysogenum, Tricoderma reseei, etc. Fungal that will be used to produce crude xylanase enzyme in this study is T. Viride ITB CC L.67. It is the purposes of this research to study the influence of pretreatment of EFB for the enzymatic hydrolysis process, optimation of temperature and pH of the hydrolysis process, the influence of substrate and enzyme concentration to the enzymatic hydrolysis process, the dynamics of hydrolysis process and followingly to study the kinetics of this process. Xylose as the product of enzymatic hydrolysis process analyzed by HPLC. The results show that the thermal pretreatment of EFB enhance the enzymatic hydrolysis process. The enzymatic hydrolysis can be well approached by the Michaelis Menten kinetic model, and kinetic parameters are obtained from experimental data.

Keywords: oil palm empty fruit bunches (EFB), xylose, enzymatic hydrolysis, kinetic modelling

Procedia PDF Downloads 387

Authors: Helen Huang, Francisco Javier Quesada Ocet, Blanca Quesada Oce, Javier Jimenez Bello, Victor Palanca Gil, Alba Cervero Rubio, Ana Paya Chaume, Alejandro Herreros-Pomares, Fernando Vidal-Vanaclocha, Rafael Paya Serrano, Aurelio Quesada Dorador, Monica Soliman

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Background: Cancer favors both the pro-inflammatory state and autonomic dysfunction, two important mechanisms in the genesis of AF. Atrial remodeling might be caused as a result of paraneoplastic conditions or the result of direct expression of neoplasia. Here, we hypothesize that cancer, through inflammatory mediators, may favor the appearance of AF and patients with the first episode of AF could have a higher risk of developing cancer. Method: Data was collected from patients who attended the emergency department of our hospital for the first episode of AF, diagnosed electrocardiographically, between 2010-2015 (n = 712). The minimum follow-up was 2 years, recording the appearance of cancer, total mortality, recurrences of AF and other events. Patients who developed cancer and those who did not during the 2 years after the onset of AF were compared, as well as with the incidence of cancer in Spain in 2012. Results: After 2 years, 35 patients (4.91%) were diagnosed with cancer, with an annual incidence of 2.45%. Hematological neoplasms were the most frequent (34.28%). The cancer group was older (76.68 +/-12.75 years vs 74.16 +/-12.71; p <0.05) and had fewer typical symptoms (palpitations) (33.38% vs 14.28% , p <0.05). The incidence of cancer in Spain during 2012 was 0.46%, much lower than our sample. When comparing the incidence by age, these differences were maintained both in those over 65 years of age and in those under 65 years of age (2.17% vs. 0.28%; 0.28% vs. 0.18% respectively). Discussion: Therefore, a high incidence of cancer in patients with the first episode of AF was observed (the annual incidence of 2.45% after the onset of AF is 6.1 times that of the general population). After the evaluation of patients with AF in their first detected episode, surveillance of the appearance of cancer should be considered in clinical practice.

Keywords: cancer, cardiovascular outcomes, atrial fibrillation, inflammation

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Authors: Taleb L., Benarbia M., Boutira F. M., Allam H., Boukerche A.

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Introduction and purpose of the study: Meningiomas are the most common non-glial intracranial tumors in adults, accounting for approximately 30% of all central nervous system tumors. The aim of our study is to determine the epidemiological, clinical, therapeutic, and evolutionary characteristics of a cohort of patients with intracranial meningioma treated with radiotherapy at the Emir Abdelkader Cancer Center in Oran. Material and methods: This is a retrospective study of 44 patients during the period from 2014 to 2020. The overall survival and relapse-free survival curves were calculated using the Kaplan-Meier method. Results and statistical analysis: The median age of the patients was 49 years [21-76 years] with a clear female predominance (sex ratio=2.4). The average diagnostic delay was seven months [2 to 24 months], the circumstances of the discovery of which were dominated by headaches in 54.5% of cases (n=24), visual disturbances in 40.9% (n=18), and motor disorders in 15.9% (n=7). The seat of the tumor was essentially at the level of the base of the skull in 52.3% of patients (n=23), including 29.5% (n=13) at the level of the cavernous sinus, 27.3% (n=12) at the parasagittal level and 20.5% (n=9) at the convexity. The diagnosis was confirmed surgically in 36 patients (81.8%) whose anatomopathological study returned in favor of grades I, II, and III in respectively 40.9%, 29.5%, and 11.4% of the cases. Radiotherapy was indicated postoperatively in 45.5% of patients (n=20), exclusive in 27.3% (n=12) and after tumor recurrence in 27.3% of cases (n=18). The irradiation doses delivered were as follows: 50 Gy (20.5%), 54 Gy (65.9%), and 60 Gy (13.6%). With a median follow-up of 69 months, the probabilities of relapse-free survival and overall survival at three years are 93.2% and 95.4%, respectively, whereas they are 71.2% and 80.7% at five years. Conclusion: Meningiomas are common primary brain tumors. Most often benign but can also progress aggressively. Their treatment is essentially surgical, but radiotherapy retains its place in specific situations, allowing good tumor control and overall survival.

Keywords: diagnosis, meningioma, surgery, radiotherapy, survival

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Authors: Samuel Asrat

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Infusion pumps have become indispensable tools in modern healthcare, allowing for precise and controlled delivery of fluids, medications, and nutrients to patients. This paper provides an overview of the historical development, measurement, and parts of infusion pumps. The historical development of infusion pumps can be traced back to the early 1960s when the first rudimentary models were introduced. These early pumps were large, cumbersome, and often unreliable. However, advancements in technology and engineering over the years have led to the development of smaller, more accurate, and user-friendly infusion pumps. Measurement of infusion pumps involves assessing various parameters such as flow rate, volume delivered, and infusion duration. Flow rate, typically measured in milliliters per hour (mL/hr), is a critical parameter that determines the rate at which fluids or medications are delivered to the patient. Accurate measurement of flow rate is essential to ensure the proper administration of therapy and prevent adverse effects. Infusion pumps consist of several key parts, including the pump mechanism, fluid reservoir, tubing, and control interface. The pump mechanism is responsible for generating the necessary pressure to push fluids through the tubing and into the patient's bloodstream. The fluid reservoir holds the medication or solution to be infused, while the tubing serves as the conduit through which the fluid travels from the reservoir to the patient. The control interface allows healthcare providers to program and adjust the infusion parameters, such as flow rate and volume. In conclusion, infusion pumps have evolved significantly since their inception, offering healthcare providers unprecedented control and precision in delivering fluids and medications to patients. Understanding the historical development, measurement, and parts of infusion pumps is essential for ensuring their safe and effective use in clinical practice.

Keywords: dip, ip, sp, is

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Authors: Guoqiang Yu, Mehrana Mohtasebi, Jinghong Sun, Thomas Pittman

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Malignant glioma (MG) is the most common type of primary malignant brain tumor. Surgical resection of MG remains the cornerstone of therapy, and the extent of resection correlates with patient survival. A limiting factor for resection, however, is the difficulty in differentiating the tumor from normal tissue during surgery. Fluorescence imaging is an emerging technique for real-time intraoperative visualization of MGs and their boundaries. However, most clinical-grade neurosurgical operative microscopes with fluorescence imaging ability are hampered by low adoption rates due to high cost, limited portability, limited operation flexibility, and lack of skilled professionals with technical knowledge. To overcome the limitations, we innovatively integrated miniaturized light sources, flippable filters, and a recording camera to the surgical eye loupes to generate a wearable fluorescence eye loupe (FLoupe) device for intraoperative imaging of fluorescent MGs. Two FLoupe prototypes were constructed for imaging of Fluorescein and 5-aminolevulinic acid (5-ALA), respectively. The wearable FLoupe devices were tested on tumor-simulating phantoms and patients with MGs. Comparable results were observed against the standard neurosurgical operative microscope (PENTERO® 900) with fluorescence kits. The affordable and wearable FLoupe devices enable visualization of both color and fluorescence images with the same quality as the large and expensive stationary operative microscopes. The wearable FLoupe device allows for a greater range of movement, less obstruction, and faster/easier operation. Thus, it reduces surgery time and is more easily adapted to the surgical environment than unwieldy neurosurgical operative microscopes.

Keywords: fluorescence guided surgery, malignant glioma, neurosurgical operative microscope, wearable fluorescence imaging device

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Authors: I. Benhsine, M. Hellou, F. Lominé, Y. Roques

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During the manufacture of fertilizer, it is necessary to add water for granulation purposes. The water content is then removed or reduced using rotary dryers. They are commonly used to dry wet granular materials and they are usually fitted with lifting flights. The transport of granular materials occurs when particles cascade from the lifting flights and fall into the air stream. Each cascade consists of a lifting and a falling cycle. Lifting flights are thus of great importance for the transport of granular materials along the dryer. They also enhance the contact between solid particles and the air stream. Optimization of the drying process needs an understanding of the behavior of granular materials inside a rotary dryer. Different approaches exist to study the movement of granular materials inside the dryer. Most common of them are based on empirical formulations or on study the movement of the bulk material. In the present work, we are interested in the behavior of each particle in the cross section of the dryer using Discrete Element Method (DEM) to understand. In this paper, we focus on studying the hold-up, the cascade patterns, the falling time and the falling length of the particles leaving the flights. We will be using two segment flights. Three different profiles are used: a straight flight (180° between both segments), an angled flight (with an angle of 150°), and a right-angled flight (90°). The profile of the flight affects significantly the movement of the particles in the dryer. Changing the flight angle changes the flight capacity which leads to different discharging profile of the flight, thus affecting the hold-up in the flight. When the angle of the flight is reduced, the range of the discharge angle increases leading to a more uniformed cascade pattern in time. The falling length and the falling time of the particles also increase up to a maximum value then they start decreasing. Moreover, the results show an increase in the falling length and the falling time up to 70% and 50%, respectively, when using a right-angled flight instead of a straight one.

Keywords: discrete element method, granular materials, lifting flight, rotary dryer

Procedia PDF Downloads 324

Authors: Asad Yousuf

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Purpose: The aim of the present study was to audit treatment planning system beam dataset for small field output factors against standard dataset produced by radiological physics center (RPC) from a multicenter study. Such data are crucial for validity of special techniques, i.e., IMRT or stereotactic radiosurgery. Materials/Method: In this study, multiple small field size output factor datasets were measured and calculated for 6 to 18 MV x-ray beams using the RPC recommend methods. These beam datasets were measured at 10 cm depth for 10 × 10 cm2 to 2 × 2 cm2 field sizes, defined by collimator jaws at 100 cm. The measurements were made with a Landauer’s nanoDot OSLDs whose volume is small enough to gather a full ionization reading even for the 1×1 cm2 field size. At our institute the beam data including output factors have been commissioned at 5 cm depth with an SAD setup. For comparison with the RPC data, the output factors were converted to an SSD setup using tissue phantom ratios. SSD setup also enables coverage of the ion chamber in 2×2 cm2 field size. The measured output factors were also compared with those calculated by Eclipse™ treatment planning software. Result: The measured and calculated output factors are in agreement with RPC dataset within 1% and 4% respectively. The large discrepancies in TPS reflect the increased challenge in converting measured data into a commissioned beam model for very small fields. Conclusion: OSLDs are simple, durable, and accurate tool to verify doses that delivered using small photon beam fields down to a 1x1 cm2 field sizes. The study emphasizes that the treatment planning system should always be evaluated for small field out factors for the accurate dose delivery in clinical setting.

Keywords: small field dosimetry, optically stimulated luminescence, audit treatment, radiological physics center

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Authors: Hao Min Chuah, Tatsuya Yamazaki, Ryosui Iwasawa, Tatsumi Suto

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In recent years, with the advancement of digital technology, the movement to introduce so-called ICT (Information and Communication Technology), such as computer technology and network technology, to civil engineering construction sites and construction sites is accelerating. As part of this movement, attempts are being made in various situations to reproduce actual sites inside computers and use them for designing and construction planning, as well as for training inexperienced engineers. The installation of wave-dissipating blocks on coasts, etc., is a type of work that has been carried out by skilled workers based on their years of experience and is one of the tasks that is difficult for inexperienced workers to carry out on site. Wave-dissipating blocks are structures that are designed to protect coasts, beaches, and so on from erosion by reducing the energy of ocean waves. Wave-dissipating blocks usually weigh more than 1 t and are installed by being suspended by a crane, so it would be time-consuming and costly for inexperienced workers to train on-site. In this paper, therefore, a block installation simulator is developed based on Unity 3D, a game development engine. The simulator computes porosity. Porosity is defined as the ratio of the total volume of the wave breaker blocks inside the structure to the final shape of the ideal structure. Using the evaluation of porosity, the simulator can determine how well the user is able to install the blocks. The voxelization technique is used to calculate the porosity of the structure, simplifying the calculations. Other techniques, such as raycasting and box overlapping, are employed for accurate simulation. In the near future, the simulator will install an automatic block installation algorithm based on combinatorial optimization solutions and compare the user-demonstrated block installation and the appropriate installation solved by the algorithm.

Keywords: 3D simulator, porosity, user interface, voxelization, wave-dissipating blocks

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Authors: Mateusz Frydrych

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The construction of diaphragm walls as excavation shoring as well as part of deep foundations is widely used in geotechnical engineering. Today's design challenges lie in the optimal dimensioning of the cross-section, which is demanded by technological considerations. Also in force is the issue of optimization and sustainable use of construction materials, including reduction of carbon footprint, which is currently a relevant challenge for the construction industry. The author presents the concept of an approach to achieving increased efficiency of diaphragm wall excavation shoring by using structural compression technology. The author proposes to implement prestressed tendons in a non-linear manner in the reinforcement cage. As a result bending moment is reduced, which translates into a reduction in the amount of steel needed in the section, a reduction in displacements, and a reduction in the scratching of the casing, including the achievement of better tightness. This task is rarely seen and has not yet been described in a scientific way in the literature. The author has developed a dynamic numerical model that allows the dimensioning of the cross-section of a prestressed shear wall, as well as the study of casing displacements and cross-sectional forces in any defined computational situation. Numerical software from the Sofistik - open source development environment - was used for the study, and models were validated in Plaxis software . This is an interesting idea that allows for optimizing the execution of construction works and reducing the required resources by using fewer materials and saving time. The author presents the possibilities of a prestressed diaphragm wall, among others, using. The example of a diaphragm wall working as a cantilever at the height of two underground floors without additional strutting or stability protection by using ground anchors. This makes the execution of the work more criminal for the contractor and, as a result, cheaper for the investor.

Keywords: prestressed diaphragm wall, Plaxis, Sofistik, innovation, FEM, optimisation

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Authors: Lingxia Li, Frédéric Schnell, Shuzhe Ding, Solène Le Douairon Lahaye

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Background: The risk of sudden cardiac arret/death (SCA/D) in athletes is controversial. There is a lack of meta-analyses assessing the sex differences in the risk of SCA/D in competitive athletes. Purpose: The aim of the present study was to evaluate sex differences in the incidence of SCA/D in competitive athletes using meta-analyses. Methods: The systematic review was registered in the PROSPERO database (registration ID: CRD42023432022) and was conducted according to the PRISMA guidelines. PubMed, Embase, Scopus, SPORT Discus and Cochrane Library were searched up to July 2023. To avoid systematic bias in data pooling, only studies with data for both sexes were included. Results: From the 18 included studies, 2028 cases of SCA/D were observed (males 1821 (89.79%), females 207 (10.21%)). The age ranges from the adolescents (<26 years) to the elderly (>45 years). The incidence in male athletes was 1.32/100,000 AY (95% CI: [0.90, 1.93]) and in females was 0.26/100,000 AY (95% CI: [0.16, 0.43]), the incidence rate ratio (IRR) was 6.43 (95% CI: [4.22, 9.79]). The subgroup synthesis showed a higher incidence in males than in females in both age groups <25 years and ≤35 years, the IRR was 5.86 (95% CI: [4.69, 7.32]) and 5.79 (95% CI: [4.73, 7.09]), respectively. When considering the events, the IRR was 6.73 (95%CI: [3.06, 14.78]) among studies involving both SCA/D events and 7.16 (95% CI: [4.93, 10.40]) among studies including only cases of SCD. The available clinical evidence showed that cardiac events were most frequently seen in long-distance running races (26, 35.1%), marathon (16, 21.6%) and soccer (10, 13.5%). Coronary artery disease (14, 18.9%), hypertrophic cardiomyopathy (8, 10.8%), and arrhythmogenic right ventricular cardiomyopathy (7, 9.5%) are the most common causes of SCA/D in competitive athletes. Conclusion: The meta-analysis provides evidence of sex differences in the incidence of SCA/D in competitive athletes. The incidence of SCA/D in male athletes was 6 to 7 times higher than in females. Identifying the reasons for this difference may have implications for targeted the prevention of fatal evets in athletes.

Keywords: incidence, sudden cardiac arrest, sudden cardiac death, sex difference, athletes

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Authors: Addharu Eri, Ningsih P. Lestari, Setyorini Adheliya, Syaiputri Khaidifah

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Rawa Pening is a lake at the Ambarawa Basin in Central Java, Indonesia. It serves as a source of power (hydroelectricity), irrigation, and flood control. The potential of this lake is getting worse by the presence of aquatic plants (Eichhornia crassipes) that grows wild, and it can make the lake covered by the cumulation of rotten E. crassipes. This cumulation causes the sediment formation which has high organic material composition. Sediment formation will be lead into a shallowing of the lake and affect water’s quality. The deposition of organic material produces methane gas and hydrogen sulfide, which in rain would turn the water muddy and decompose. Decomposition occuring in the water due to microbe activity in lake's water. The shallowing of Rawa Pening Lake not only will physically can reduce water discharge, but it also has ecologically major impact on water organism. The condition of Rawa Pening Lake peats can not be considered as unimportant issue. One of the solutions that can be applied is by using the peats as a compound materials on growing horticultural crops because the organic materials content on the mineral soil is low, particularly on an old soils. The horticultural crops required organic materials for growth promoting. The horticultural crops that use in this research is mustard cabbage (Brassica sp.). Using Rawa Pening's peats as the medium of plants with high organic materials that also can ameliorate soil’s physical properties, and indirectly serves as soil conditioner. Research will be focus on the peat’s contents and mustard cabbage product’s content. The contents that will be examined is the N-available, Ca, Mg, K, P, and C-organic. The analysis of Ca, Mg, and K is use soil base saturation measurement method and extracting soil is use NH4OAC solution. The aim of this study is to use the peats of Rawa Pening Lake as soil conditioner and increase the productivity of Brassica sp.

Keywords: Brassica sp., peats, rawa pening lake, soil conditioner

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Authors: Sumara Khanzada

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This research investigated how much stress is induced by various study-related factors, in undergraduate students belonging to a renowned university in Karachi along with the unhealthy coping strategy the students use to manage the stress. The study related factors considered for the purpose of the study were curriculum and instruction based stress, teacher-student relationship, assessment system and different components related to academic work. A survey in which questionnaires were administered to hundred students was conducted. The data were analyzed quantitatively to determine the percentages of stress induced by the various factors. The study found that student-teacher relationship is the strongest factor that causes stress in the undergraduate students specifically when teachers do not deliver the lectures effectively and give assignments and presentations to students without clear guidelines and instructions. The second important factor that causes stress was the different components of academic life, such as, parental expectations and pressures to achieve one's goals. Assessment system was found to be the third key factor inducing stress and affecting students' cognitive and psychological functioning. The most commonly used unhealthy coping strategy for stress management was procrastination. In light of the findings, it is recommended that importance be given to teacher training to ensure that instruction is proper and healthy teacher student relationship exists. Effective support programs, workshops, seminars, and different awareness programs should be arranged for promoting awareness regarding mental health in educational institutions. Moreover, additional zero credit courses should be offered to teach students how to learn stress management and healthy coping skills. Sumara Khanzada Clinical Psychologist [email protected]

Keywords: Stress, coping stretigies, acadamic stress, relationship

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Authors: A. R. Diniz, P. Borrego, I. Bártolo, N. Taveira

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Cell-to-cell transmission plays a critical role in the spread of HIV-1 infection in vitro and in vivo. Inhibition of HIV-1 cell-associated infection by antiretroviral drugs and neutralizing antibodies (NAbs) is more difficult compared to cell-free infection. Limited data exists on cell-associated infection by HIV-2 and its inhibition. In this work, we determined the ability of entry inhibitors to inhibit HIV-1 and HIV-2 cell-to cell fusion as a proxy to cell-associated infection. We developed a method in which Hela-CD4-cells are first transfected with a Tat expressing plasmid (pcDNA3.1+/Tat101) and infected with recombinant vaccinia viruses expressing either the HIV-1 (vPE16: from isolate HTLV-IIIB, clone BH8, X4 tropism) or HIV-2 (vSC50: from HIV-2SBL/ISY, R5 and X4 tropism) envelope glycoproteins (M.O.I.=1 PFU/cell).These cells are added to TZM-bl cells. When cell-to-cell fusion (syncytia) occurs the Tat protein diffuses to the TZM-bl cells activating the expression of a reporter gene (luciferase). We tested several entry inhibitors including the fusion inhibitors T1249, T20 and P3, the CCR5 antagonists MVC and TAK-779, the CXCR4 antagonist AMD3100 and several HIV-2 neutralizing antibodies (Nabs). All compounds inhibited HIV-1 and HIV-2 cell fusion albeit to different levels. Maximum percentage of HIV-2 inhibition (MPI) was higher for fusion inhibitors (T1249- 99.8%; P3- 95%, T20-90%) followed by co-receptor antagonists (MVC- 63%; TAK-779- 55%; AMD3100- 45%). NAbs from HIV-2 infected patients did not prevent cell fusion up to the tested concentration of 4μg/ml. As for HIV-1, MPI reached 100% with TAK-779 and T1249. For the other antivirals, MPIs were: P3-79%; T20-75%; AMD3100-61%; MVC-65%.These results are consistent with published data. Maraviroc had the lowest IC50 both for HIV-2 and HIV-1 (IC50 HIV-2= 0.06 μM; HIV-1=0.0076μM). Highest IC50 were observed with T20 for HIV-2 (3.86μM) and with TAK-779 for HIV-1 (12.64μM). Overall, our results show that entry inhibitors in clinical use are less effective at preventing Env mediated cell-to-cell-fusion in HIV-2 than in HIV-1 which suggests that cell-associated HIV-2 infection will be more difficult to inhibit compared to HIV-1. The method described here will be useful to screen for new HIV entry inhibitors.

Keywords: cell-to-cell fusion, entry inhibitors, HIV, NAbs, vaccinia virus

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Authors: Shahzad Karim Bhatti

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Background: Ozone is a combination of oxygen and can be used in treatment of low back pain due to herniated disc. It is a minimally invasive procedure using biochemical properties of ozone resulting in reduced volume of disc and inflammation resulting in significant pain relief. Aim: The purpose of this study was to evaluate the effectiveness of ozone therapy in combination with peri-ganglionic injection of local anesthetic and corticosteroid. Material and Methods: This retrospective study was done at the Interventional Radiology Department of Mayo Hospital, Lahore. A total of 49000 patients were included from January 2008 to March 2022. All the patients presented with clinical signs and symptoms of lumber disc herniation, which was confirmed by a MRI scan of the lumbar sacral spine. The pain reduction was calculated using modified MacNab method. All the patients underwent percutaneous injection of ozone at a concentration of 27 micrograms/ml to lumber disc under fluoroscopic guidance with combination of local anesthetic and corticosteroid in peri-ganglionic space. Results were evaluated by two expert observers who were blinded to patient treatment. Results A satisfactory therapeutic outcome was obtained. 55% of the patients showed complete recovery with resolution of symptoms. 20% of the patients complained of occasional episodic pain with no limitation of occupational activity. 15% of cases showed insufficient improvement. 5% of cases had insufficient improvement and went for surgery. 10% of cases never turned up after the first visit. Conclusion Intradiscal ozone for the treatment of herniated discs has revolutionized percutaneous approach to nerve root compression making it safer, economical and easier to repeat without any side effects than treatments currently used in Pakistan.

Keywords: pain, prolapse, Ozone, backpain

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Authors: Peter M. Schneider, Batyr Garlyyev, Sebastian A. Watzele, Aliaksandr S. Bandarenka

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Functional nanostructures such as nanoparticles are a promising class of materials for energy applications due to their unique properties. Bottom-up synthetic routes for nanostructured materials often involve multiple synthesis steps and the use of surfactants, reducing agents, or stabilizers. This results in complex and extensive synthesis protocols. In recent years, a novel top-down synthesis approach to form metal nanoparticles has been established, in which bulk metal wires are immersed in an electrolyte (primarily alkali earth metal based) and subsequently subjected to a high alternating potential. This leads to the generation of nanoparticles dispersed in the electrolyte. The main advantage of this facile top-down approach is that there are no reducing agents, surfactants, or precursor solutions. The complete synthesis can be performed in one pot involving one main step with consequent washing and drying of the nanoparticles. More recent studies investigated the effect of synthesis parameters such as potential amplitude, frequency, electrolyte composition, and concentration on the size and shape of the nanoparticles. Here, we investigate the electrochemical erosion of various metal wires such as Ti, Pt, Pd, and Sn in various electrolyte compositions via this facile top-down technique and its experimental optimization to successfully synthesize nanostructured materials for various energy applications. As an example, for Pt and Pd, homogeneously distributed nanoparticles on carbon support can be obtained. These materials can be used as electrocatalyst materials for the oxygen reduction reaction (ORR) and hydrogen evolution reaction (HER), respectively. In comparison, the top-down erosion of Sn wires leads to the formation of nanoparticles, which have great potential as oxygen evolution reaction (OER) support materials. The application of the technique on Ti wires surprisingly leads to the formation of nanowires, which show a high surface area and demonstrate great potential as an alternative support material to carbon.

Keywords: ORR, electrochemistry, electrocatalyst, synthesis

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Authors: Sameer Gupta, Prant Gupta

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Context: Fractures in the distal humerus are complex and challenging injuries for orthopaedic surgeons that can be effectively treated with open reduction and internal fixation. Aims: The study analyses clinical outcomes in patients with intra-articular distal humerus fractures (AO type 13 C3 excluded) treated using a different method of fixation ( LCPMS). Subject and Methods: A study was performed, and the author's personal experiences were reported. Thirty patients were treated using an intercondylar screw with lateral column plating and percutaneous medial column screw fixation. Detailed analysis was done for functional outcomes (average arc of motion, union rate, and complications). Statistical Analysis Used: SPSS software version 22.0 was used for statistical analysis. Results: In our study, at the end of 6 months, Overall good to excellent results were achieved in 28 patients out of 30 after analysis on the basis of MEP score. The majority of patients regained full arc of motion, achieved fracture union without any major complications, and were able to perform almost all activities of daily living (which required good elbow joint movements and functions). Conclusion: We concluded that this novel method provides adequate stability and anatomical reconstruction with an early union rate observed at the end of 6 months. Excellent functional outcome was observed in almost all the patients because of less operating time and initiation of early physiotherapy, as most of the patients experienced mild nature of pain post-surgery.

Keywords: intra arricular distal humerus fracture, percutaneous medial screw, lateral column plate, arc of motion

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Authors: Louise Moles, Steve Riley, Sarah D. Lichenstein, Marzieh Babaeianjelodar, Robert Kohler, Annie Cheng, Corey Horien Abigail Greene, Wenjing Luo, Jonathan Ahern, Bohan Xu, Yize Zhao, Chun Chieh Fan, R. Todd Constable, Sarah W. Yip

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Background: Risks for depression are myriad and include both genetic and brain-based factors. However, relationships between these systems are poorly understood, limiting understanding of disease etiology, particularly at the developmental level. Methods: We use a data-driven machine learning approach connectome-based predictive modeling (CPM) to identify functional connectivity signatures associated with polygenic risk scores for depression (DEP-PRS) among youth from the Adolescent Brain and Cognitive Development (ABCD) study across diverse brain states, i.e., during resting state, during affective working memory, during response inhibition, during reward processing. Results: Using 10-fold cross-validation with 100 iterations and permutation testing, CPM identified connectivity signatures of DEP-PRS across all examined brain states (rho’s=0.20-0.27, p’s<.001). Across brain states, DEP-PRS was positively predicted by increased connectivity between frontoparietal and salience networks, increased motor-sensory network connectivity, decreased salience to subcortical connectivity, and decreased subcortical to motor-sensory connectivity. Subsampling analyses demonstrated that model accuracies were robust across random subsamples of N’s=1,000, N’s=500, and N’s=250 but became unstable at N’s=100. Conclusions: These data, for the first time, identify neural networks of polygenic depression risk in a large sample of youth before the onset of significant clinical impairment. Identified networks may be considered potential treatment targets or vulnerability markers for depression risk.

Keywords: genetics, functional connectivity, pre-adolescents, depression

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Authors: Gyeongbeom Yi

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The purpose of this study is to introduce the analytic solution for determining the optimal capacity (lot-size) of a multiproduct, multistage production and inventory system to meet the finished product demand. Reasonable decision-making about the capacity of processes and storage units is an important subject for industry. The industrial solution for this subject is to use the classical economic lot sizing method, EOQ/EPQ (Economic Order Quantity/Economic Production Quantity) model, incorporated with practical experience. However, the unrealistic material flow assumption of the EOQ/EPQ model is not suitable for chemical plant design with highly interlinked processes and storage units. This study overcomes the limitation of the classical lot sizing method developed on the basis of the single product and single stage assumption. The superstructure of the plant considered consists of a network of serially and/or parallelly interlinked processes and storage units. The processes involve chemical reactions with multiple feedstock materials and multiple products as well as mixing, splitting or transportation of materials. The objective function for optimization is minimizing the total cost composed of setup and inventory holding costs as well as the capital costs of constructing processes and storage units. A novel production and inventory analysis method, PSW (Periodic Square Wave) model, is applied. The advantage of the PSW model comes from the fact that the model provides a set of simple analytic solutions in spite of a realistic description of the material flow between processes and storage units. The resulting simple analytic solution can greatly enhance the proper and quick investment decision for plant design and operation problem confronted in diverse economic situations.

Keywords: analytic solution, optimal design, process-storage network

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Authors: Daniel Fundi Murithi

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Data from economic, social, clinical, and industrial studies are in some way incomplete or incorrect due to censoring. Such data may have adverse effects if used in the estimation problem. We propose the use of Maximum Likelihood Estimation (MLE) under a progressive type-II censoring scheme to remedy this problem. In particular, maximum likelihood estimates (MLEs) for the location (µ) and scale (λ) parameters of two Parameter Rayleigh distribution are realized under a progressive type-II censoring scheme using the Expectation-Maximization (EM) and the Newton-Raphson (NR) algorithms. These algorithms are used comparatively because they iteratively produce satisfactory results in the estimation problem. The progressively type-II censoring scheme is used because it allows the removal of test units before the termination of the experiment. Approximate asymptotic variances and confidence intervals for the location and scale parameters are derived/constructed. The efficiency of EM and the NR algorithms is compared given root mean squared error (RMSE), bias, and the coverage rate. The simulation study showed that in most sets of simulation cases, the estimates obtained using the Expectation-maximization algorithm had small biases, small variances, narrower/small confidence intervals width, and small root of mean squared error compared to those generated via the Newton-Raphson (NR) algorithm. Further, the analysis of a real-life data set (data from simple experimental trials) showed that the Expectation-Maximization (EM) algorithm performs better compared to Newton-Raphson (NR) algorithm in all simulation cases under the progressive type-II censoring scheme.

Keywords: expectation-maximization algorithm, maximum likelihood estimation, Newton-Raphson method, two-parameter Rayleigh distribution, progressive type-II censoring

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Authors: Ramish, Farhan Khalique Awan

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Kinematic redundancy within the manipulators presents extended dexterity and manipulability to the manipulators. Redundant serial robotic manipulators are very popular in industries due to its competencies to keep away from singularities during normal operation and fault tolerance because of failure of one or more joints. Such fault tolerant manipulators are extraordinarily beneficial in applications where human interference for repair and overhaul is both impossible or tough; like in case of robotic arms for space programs, nuclear applications and so on. The design of this sort of fault tolerant serial 3 DoF manipulator is presented in this paper. This work was the extension of the author’s previous work of designing the simple 3R serial manipulator. This work is the realization of the previous design with optimizing the link lengths for incorporating the feature of fault tolerance. Various measures have been followed by the researchers to quantify the fault tolerance of such redundant manipulators. The fault tolerance in this work has been described in terms of the worst-case measure of relative manipulability that is, in fact, a local measure of optimization that works properly for certain configuration of the manipulators. An optimum fault tolerant Jacobian matrix has been determined first based on prescribed null space properties after which the link parameters have been described to meet the given Jacobian matrix. A solid model of the manipulator was then developed to realize the mathematically rigorous design. Further work was executed on determining the dynamic properties of the fault tolerant design and simulations of the movement for various trajectories have been carried out to evaluate the joint torques. The mathematical model of the system was derived via the Euler-Lagrange approach after which the same has been tested using the RoboAnalyzer© software. The results have been quite in agreement. From the CAD model and dynamic simulation data, the manipulator was fabricated in the workshop and Advanced Machining lab of NED University of Engineering and Technology.

Keywords: fault tolerant, Graham matrix, Jacobian, kinematics, Lagrange-Euler

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Authors: Athulya Jayakumar, M. Manjula

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Though there has been a shift in the understanding of homosexuality from being a sin, crime or pathology in the medical and legal perspectives, the acceptance of homosexuality still remains very scanty in the Indian subcontinent. The present case study is a 24-year-old female who has completed a diploma in polytechnic engineering and residing in the state of Kerala. She initially presented with her husband with complaints of lack of sexual desire and non-cooperation from the index client. After an initial few sessions, the client revealed, in an individual session, about her homosexual orientation which was unknown to her family. She has had multiple short-term relations with females and never had any heterosexual orientation/interest. During her adolescence, she was wondering if she could change herself into a male. However, currently, she accepts her gender. She never wanted a heterosexual marriage; but, had to succumb to the pressure of mother, as a result of a series of unexpected incidents at home and had to agree for the marriage, also with a hope that she may change herself into a bi-sexual. The client was able to bond with the husband emotionally but the multiple attempts at sexual intercourse, at the insistence of the husband, had always been non-pleasurable and induced a sense of disgust. Currently, for several months, there has not been any sexual activity. Also, she actively avoids any chance to have a warm communication with him so that she can avoid chances of him approaching her in a sexual manner. The case study is an attempt to highlight the culture and the struggles of a homosexual individual who comes to therapy for wanting to be a ‘normal wife’ despite having knowledge of legal rights and scenario. There is a scarcity of Indian literature that has systematically investigated issues related to homosexuality. Data on prevalence, emotional problems faced and clinical services available are sparse though it is crucial for increasing understanding of sexual behaviour, orientation and difficulties faced in India.

Keywords: case study, culture, cognitive behavior therapy, female homosexuality

Procedia PDF Downloads 344

Authors: Ningning Liu, Gaoding Jia, Yinshan Wang, Haimei Li, Xinian Zuo, Yufeng Wang, Lu Liu, Qiujin Qian

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Background: There has been speculation that a high IQ may not necessarily provide protection against attention deficit hyperactivity disorder (ADHD), and there may be a U-shaped correlation between IQ and ADHD symptoms. However, this speculation has not been validated in the ADHD population in any study so far. Method: We conducted a study with 5,138 children who have been professionally diagnosed with ADHD and have a wide range of IQ levels. General Linear Models were used to determine the optimal model between IQ and ADHD core symptoms with sex and age as covariates. The ADHD symptoms we looked at included the total scores (TO), inattention (IA) and hyperactivity/impulsivity (HI). Wechsler Intelligence scale were used to assess IQ [Full-Scale IQ (FSIQ), Verbal IQ (VIQ), and Performance IQ (PIQ)]. Furthermore, we examined the correlation between IQ and the execution function [Behavior Rating Inventory of Executive Function (BRIEF)], as well as between IQ and brain surface area, to determine if the associations between IQ and ADHD symptoms are reflected in executive functions and brain structure. Results: Consistent with previous research, the results indicated that FSIQ and VIQ both showed a linear negative correlation with the TO and IA scores of ADHD. However, PIQ showed an inverted U-shaped relationship with the TO and HI scores of ADHD, with 103 as the peak point. These findings were also partially reflected in the relationship between IQ and executive functions, as well as IQ and brain surface area. Conclusion: To sum up, the relationship between IQ and ADHD symptoms is not straightforward. Our study confirms long-standing academic hypotheses and finds that PIQ exhibits an inverted U-shaped relationship with ADHD symptoms. This study enhances our understanding of symptoms and behaviors of ADHD with varying IQ characteristics and provides some evidence for targeted clinical intervention.

Keywords: ADHD, IQ, execution function, brain imaging

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Authors: Eman Ayman, Gehan Nagy

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The learning environment has four main parameters that affect its efficiency which they are: pedagogy, user, technology, and space. According to Morrone, enhancing these parameters to be adaptable for future developments is essential. The educational organization will be in need of developing its learning spaces. Flexibility of design an immersive technology could be used as tools for this development. when flexible design concepts are used, learning spaces that can accommodate a variety of teaching and learning activities are created. To accommodate the various needs and interests of students, these learning spaces are easily reconfigurable and customizable. The immersive learning opportunities offered by technologies like virtual reality, augmented reality, and interactive displays, on the other hand, transcend beyond the confines of the traditional classroom. These technological advancements could improve learning. This thesis highlights the problem of the lack of innovative, flexible learning spaces in educational institutions. It aims to develop guidelines for enhancing the learning environment by the integration of flexible design and immersive technology. This research uses a mixed method approach, both qualitative and quantitative: the qualitative section is related to the literature review theories and case studies analysis. On the other hand, the quantitative section will be identified by the results of the applied studies of the effectiveness of redesigning a learning space from its traditional current state to a flexible technological contemporary space that will be adaptable to many changes and educational needs. Research findings determine the importance of flexibility in learning spaces' internal design as it enhances the space optimization and capability to accommodate the changes and record the significant contribution of immersive technology that assists the process of designing. It will be summarized by the questionnaire results and comparative analysis, which will be the last step of finalizing the guidelines.

Keywords: flexibility, learning space, immersive technology, learning environment, interior design

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Authors: Hatem I. Mokhtar, Randa A. Abd-El-Salam, Ghada M. Hadad

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An improved nano-composite of self-doped polyaniline nanofibers and silica-coated magnetite nanoparticles were prepared and evaluated for suitability to magnetic dispersive micro solid-phase extraction. The work focused on optimization of the composite capacity to extract four fluoroquinolones (FQs) antibiotics, ciprofloxacin, enrofloxacin, danofloxacin, and difloxacin from water and improvement of composite stability towards acid and atmospheric degradation. Self-doped polyaniline nanofibers were prepared by oxidative co-polymerization of aniline with anthranilic acid. Magnetite nanopariticles were prepared by alkaline co-precipitation and coated with silica by silicate hydrolysis on magnetite nanoparticles surface at pH 6.5. The composite was formed by self-assembly by mixing self-doped polyaniline nanofibers with silica-coated magnetite nanoparticles dispersions in ethanol. The composite structure was confirmed by transmission electron microscopy (TEM). Self-doped polyaniline nanofibers and magnetite chemical structures were confirmed by FT-IR while silica coating of the magnetite was confirmed by Energy Dispersion X-ray Spectroscopy (EDS). Improved stability of the composite magnetic component was evidenced by resistance to degrade in 2N HCl solution. The adsorption capacity of self-doped polyaniline nanofibers based composite was higher than previously reported corresponding composite prepared from polyaniline nanofibers instead of self-doped polyaniline nanofibers. Adsorption-pH profile for the studied FQs on the prepared composite revealed that the best pH for adsorption was in range of 6.5 to 7. Best extraction recovery values were obtained at pH 7 using phosphate buffer. The best solvent for FQs desorption was found to be 0.1N HCl in methanol:water (8:2; v/v) mixture. 20 mL of Spiked water sample with studied FQs were preconcentrated using 4.8 mg of composite and resulting extracts were analysed by HPLC-UV method. The prepared composite represented a suitable adsorbent phase for magnetic dispersive micro-solid phase application.

Keywords: fluoroquinolones, magnetic dispersive micro extraction, nano-composite, self-doped polyaniline nanofibers

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Authors: Humraaz Kaja, Kofi Mensah, Frasia Oosthuizen

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Background and Aim: Vilazodone was approved in 2011 as an antidepressant to treat the major depressive disorder. As a relatively new drug, it is not clear if all adverse effects have been identified. The aim of this study was to review the adverse effects reported to the WHO Programme for International Drug Monitoring (PIDM) in order to add to the knowledge about the safety profile and adverse effects caused by vilazodone. Method: Data on adverse effects reported for vilazodone was obtained from the database VigiAccess managed by PIDM. Data was extracted from VigiAccess using Excel® and analyzed using descriptive statistics. The data collected was compared to the patient information leaflet (PIL) of Viibryd® and the FDA documents to determine adverse drug reactions reported post-marketing. Results: A total of 9708 adverse events had been recorded on VigiAccess, of which 6054 were not recorded on the PIL and the FDA approval document. Most of the reports were received from the Americas and were for adult women aged 45-64 years (24%, n=1059). The highest number of adverse events reported were for psychiatric events (19%; n=1889), followed by gastro-intestinal effects (18%; n=1839). Specific psychiatric disorders recorded included anxiety (316), depression (208), hallucination (168) and agitation (142). The systematic review confirmed several psychiatric adverse effects associated with the use of vilazodone. The findings of this study suggested that these common psychiatric adverse effects associated with the use of vilazodone were not known during the time of FDA approval of the drug and is not currently recorded in the patient information leaflet (PIL). Conclusions: In summary, this study found several adverse drug reactions not recorded in documents emanating from clinical trials pre-marketing. This highlights the importance of continued post-marketing surveillance of a drug, as well as the need for further studies on the psychiatric adverse events associated with vilazodone in order to improve the safety profile.

Keywords: adverse drug reactions, pharmacovigilance, post-marketing surveillance, vilazodone

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