Search results for: randomized controlled trials

Authors: Pierce Radecki, Pulkit Malik, Bharath Ramaswamy, Ben Shapiro

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The ability to effectively design and test magnetic nanoparticles for controlled movement has been an elusive goal in the design of these particles. Magnetic nanoparticles of various characteristics have been created for use towards therapeutic effects, however the challenge of designing for controlled movement remains unmet. A step towards design in this aspect is a first principles model that captures and predicts the behaviors of particles in a magnetic field. The model is governed by four forces acting on the particles, the magnetic gradient, the dipole-dipole forces, the steric forces, and the viscous drag force. The particles are multi-core or single core, and incorporate a preferred magnetization axis. Particles exhibit behaviors, such as chaining, in simulations that are similar to those witnessed through experimentation. Currently, experimental results are being compared to the modeling results for verification of the model, through the analysis of chaining behaviors. This modeling system will be used in designing magnetic nanoparticles for specific chaining and movement behaviors.

Keywords: controlled movement, modeling, magnetic nanoparticles, nanoparticle design

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Authors: Amirhossein Chambari

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This article proposes a bi-objective model for the facility location problem subject to congestion (overcrowding). Motivated by implementations to locate servers in internet mirror sites, communication networks, one-server-systems, so on. This model consider for situations in which immobile (or fixed) service facilities are congested (or queued) by stochastic demand to behave as M/M/1/K queues. We consider for this problem two simultaneous perspectives; (1) Customers (desire to limit times of accessing and waiting for service) and (2) Service provider (desire to limit average facility idle-time). A bi-objective model is setup for facility location problem with two objective functions; (1) Minimizing sum of expected total traveling and waiting time (customers) and (2) Minimizing the average facility idle-time percentage (service provider). The proposed model belongs to the class of mixed-integer nonlinear programming models and the class of NP-hard problems. In addition, to solve the model, controlled elitist non-dominated sorting genetic algorithms (Controlled NSGA-II) and controlled elitist non-dominated ranking genetic algorithms (NRGA-I) are proposed. Furthermore, the two proposed metaheuristics algorithms are evaluated by establishing standard multiobjective metrics. Finally, the results are analyzed and some conclusions are given.

Keywords: bi-objective, facility location, queueing, controlled NSGA-II, NRGA-I

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Authors: Joyce K. Anastasi, Bernadette Capili

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Community Engagement Strategies to Assist with the Development of an RCT Among People Living with HIV Our research team focuses on developing and testing protocols to manage chronic symptoms. For many years, our team designed and implemented symptom management studies for people living with HIV (PLWH). We identify symptoms that are not curative and are not adequately controlled by conventional therapies. As an exemplar, we describe how we successfully engaged PLWH in developing and refining our research feasibility protocol for distal sensory peripheral neuropathy (DSP) associated with HIV. With input from PLWH with DSP, our research received National Institutes of Health (NIH) research funding support. Significance: DSP is one of the most common neurologic complications in HIV. It is estimated that DSP affects 21% to 50% of PLWH. The pathogenesis of DSP in HIV is complex and unclear. Proposed mechanisms include cytokine dysregulation, viral protein-produced neurotoxicity, and mitochondrial dysfunction associated with antiretroviral medications. There are no FDA-approved treatments for DSP in HIV. Purpose: Aims: 1) to explore the impact of DSP on the lives of PLWH, 2) to identify patients’ perspectives on successful treatments for DSP, 3) to identify interventions considered feasible and sensitive to the needs of PLWH with DSP, and 4) to obtain participant input for protocol/study design. Description of Process: We conducted a needs assessment with PLWH with DSP. From our needs assessment, we learned from the patients’ perspective detailed descriptions of their symptoms; physical functioning with DSP; self-care remedies tried, and desired interventions. We also asked about protocol scheduling, instrument clarity, study compensation, study-related burdens, and willingness to participate in a randomized controlled trial (RCT) with a placebo and a waitlist group. Implications: We incorporated many of the suggestions learned from the need assessment. We developed and completed a feasibility study that provided us with invaluable information that informed subsequent NIH-funded studies. In addition to our extensive clinical and research experience working with PLWH, learning from the patient perspective helped in developing our protocol and promoting a successful plan for recruitment and retention of study participants.

Keywords: clinical trial development, peripheral neuropathy, traditional medicine, HIV, AIDS

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Authors: Christoph Schuler, Oriana Ponta

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Public Financial Management (PFM) reforms are promoted by various international organizations such as the International Monetary Fund (IMF) or the World Bank, local development banks and the donor country community to strengthen governance and accountability in developing countries across the world. Reform efforts undertaken are often systematically measured against international best practice by the application of standardized analytical instruments such as the Public Expenditure and Financial Accountability Framework (PEFA) or the Poverty Reduction Action Plan (PARP). While those instruments analyze direct achievements of PFM reforms, the long-term benefits of such reforms for society remain untapped. This gives rise to the question why the concept of impact evaluation with its experimental or quasi-experimental settings in the form of randomized control trials has rarely been applied in the context of PFM reforms. To close this gap, this study provides examples where the concept of impact evaluation can be applied to PFM reforms and thereby shifting the focus from outcome towards a long-term impact. As it is a new approach, this study does not attempt to conduct a fully flagged impact evaluation of a certain PFM reform. However, it will outline, as a form of pre-test the applicability of the impact evaluation methodology in this context, for example, by more closely analyzing the commonly used indicators (for example within PEFA or PARP). This would mean to scrutinize these indicators as to how they were designed and how they are related to the long-term impact, they should be producing. The analysis of PFM reform indicators and their relation to long-term impacts should provide practitioners and scholars alike with new insights on how to strengthen the accountability of public service delivery through successful and sustainable PFM reforms.

Keywords: accountability, impact evaluation, PFM reforms, public financial management

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Authors: Mbanzulu Kennedy, Zanga Josue, Wumba Roger

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Malaria and schistosomiasis remain life-threatening public health problems in sub-Saharan Africa. The infection pattern related to age indicates that preschool and school-age children are at the highest risk of malaria and schistosomiasis. Both parasitic infections, separately or combined, may have negative impacts on the haemoglobin concentration levels. The existing data revealed that artemisinin derivatives commonly used to cure malaria present also in antischistosomal activities. The current study investigated the impact of Artesunate-Amodiaquine (AS-AQ) on schistosomiasis when administered to treat malaria in rural area of Lemfu, DRC. A prospective longitudinal study including 171 coinfected children screened for anaemia, Schistosoma mansoni, and Plasmodium falciparum infections. The egg reduction rate and haemoglobin concentration were assessed four weeks after the treatment with AS-AQ, of all coinfected children of this series. One hundred and twenty-five (74.4%) out of 168 coinfected children treated and present during the assessment were found stool negative for S. mansoni eggs. Out of 43 (25.6%) children who remained positives, 37 (22%) showed a partial reduction of eggs amount, and no reduction was noted in 3.6% of coinfected. The mean of haemoglobin concentration and the prevalence of anaemia were, respectively, 10.74±1.5g/dl , 11.2±1.3g/dl, and 64.8%, 51.8%, respectively, before and after treatment, p<0.001. The AS-AQ commonly used against Plasmodium allowed curing S. mansoni in coinfected children and increasing the Hb level. For the future, the randomized and multicentric clinical trials are needed for a better understanding of the effectiveness of AS-AQ against Schistosoma spp. The trial registration number was 3487183.

Keywords: paludisme, schistosomiase, as-aq, enfants lemfu

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Authors: Svetlana Missina, Anatoliy Shipilov, Alexandr Vavaev

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The purpose of the present study was to investigate the relationship between sprint and vertical jump performance in elite female football players. Twenty four professional female football players (age, 18.6±3.1 years; height, 168.3±6.3 cm, body mass 61.6±7.4 kg; mean±SD) were tested for 30-m sprint time, 10-m sprint time and vertical countermovement (CMJ) and squat (SJ) jumps height. Participants performed three countermovement jumps and three squat jumps for maximal height on a force platform. Mean values of three trials were used in statistical analysis. The displacement of center of mass (COM) during flight phase (e.g. jump height) was calculated using the vertical velocity of the COM at the moment of take-off. 30-m and 10-m sprint time were measured using OptoGait optical system. The best of three trials were used for analysis. A significant negative correlation was found between 30-m sprint time and CMJ, SJ height (r = -0.85, r = -0.79 respectively), between 10-m sprint time and CMJ, SJ height (r = -0.73, r = -0.8 respectively), and step frequency was significantly related to CMJ peak power (r = -0.57). Our study indicates that there is strong correlation between sprint and jump performance in elite female football players, thus vertical jump test can be considered as a good sprint and agility predictor in female football.

Keywords: agility, female football players, sprint performance, vertical jump height

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Authors: Sheikh Omar Sillah

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Introduction: Monitoring is an important means of ensuring the smooth implementation and quality of clinical trials. For many years, traditional site monitoring approaches have been critical in detecting data errors but not optimal in identifying fabricated and implanted data as well as non-random data distributions that may significantly invalidate study results. The objective of this paper was to provide recommendations based on best statistical monitoring practices for detecting data-integrity issues suggestive of fabrication and implantation early in the study conduct to allow implementation of meaningful corrective and preventive actions. Methodology: Electronic bibliographic databases (Medline, Embase, PubMed, Scopus, and Web of Science) were used for the literature search, and both qualitative and quantitative studies were sought. Search results were uploaded into Eppi-Reviewer Software, and only publications written in the English language from 2012 were included in the review. Gray literature not considered to present reproducible methods was excluded. Results: A total of 18 peer-reviewed publications were included in the review. The publications demonstrated that traditional site monitoring techniques are not efficient in detecting data anomalies. By specifying project-specific parameters such as laboratory reference range values, visit schedules, etc., with appropriate interactive data monitoring, statistical monitoring can offer early signals of data anomalies to study teams. The review further revealed that statistical monitoring is useful to identify unusual data patterns that might be revealing issues that could impact data integrity or may potentially impact study participants' safety. However, subjective measures may not be good candidates for statistical monitoring. Conclusion: The statistical monitoring approach requires a combination of education, training, and experience sufficient to implement its principles in detecting data anomalies for the statistical aspects of a clinical trial.

Keywords: statistical monitoring, data anomalies, clinical trials, traditional monitoring

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Authors: Mohamed A. Eid, Sobhy M. Aly, Marwa M. Ibrahim, Nadia L. Radwan

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To investigate the interaction effects of vitamin D supplementation combined with aerobic exercises (AE) and conventional physical therapy program (CPTP) on balance and physical performance in children with Down syndrome (DS).Methods: A randomized controlled trial was conducted for 38 children with DS, with ages ranging from 8 to 12 years. They were divided randomly to two groups. The control group (n=19) received the CPTP, while the study group (n=19) received the CPTP, AE, and vitamin D in the form of an oral daily dose of vitamin D3 400 IU (Cholecalciferol). Evaluation of balance by using the Biodex Stability System and physical performance by using the six-minute walk test (6MWT)was performed before and after 12 weeks of the treatment program. Findings: All groups showed a significant improvement in balance and physical performance after treatment (p < 0.05). The study group showed a significant improvement in balance and physical performancecompared with that of the control group (p < 0.05). Conclusion: Vitamin D supplementation combined with AE and CPTP could improve balance and physical performance in children with DS. Therefore, vitamin D and AEshould be considered as adjunctive to the rehabilitation program of these children.

Keywords: aerobic exercises, balance, down syndrome, physical performance, vitamin D

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Authors: Mohammad Java Esmaeily

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Background: We evaluate the effects of tissue and organ perfusion during and after coronary artery bypass graft surgery with either colloid (Voluven) or crystalloid (Lactated ringers) as a prime solution. Materials and Methods: In this prospective randomized-controlled trial study, 70 patients undergoing on-pump coronary artery bypass graft surgery were randomly assigned to receive either colloid (Voluven) or crystalloid (Lactated ringer's) as a prime solution for initiation of cardiopulmonary bypass machine procedure. Tissue and organ perfusion markers, including lactate, troponin I, liver and renal function tests and electrolytes, were measured sequentially before induction (T1) to the second days after surgery (T5). Results: With the exception of chloride and potassium levels, no significant differences were detected in other measurements, and laboratory results were identical entirely in the two groups. Conclusion: Voluven® (hydroxyethyl starch, HES 130/0.4) has a not significant difference in comparison with crystalloid (Lactated ringer's) as priming solution on the basis of organ and tissue perfusion tests assessment.

Keywords: prime, colloid, crystalloid, lactate, troponin, hydroxyethyl starch

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Authors: Ayon Mukherjee

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Covariate-adjusted response-adaptive (CARA) designs use the available responses to skew the treatment allocation in a clinical trial in towards treatment found at an interim stage to be best for a given patient's covariate profile. Extensive research has been done on various aspects of CARA designs with the patient responses assumed to follow a parametric model. However, ranges of application for such designs are limited in real-life clinical trials where the responses infrequently fit a certain parametric form. On the other hand, robust estimates for the covariate-adjusted treatment effects are obtained from the parametric assumption. To balance these two requirements, designs are developed which are free from distributional assumptions about the survival responses, relying only on the assumption of proportional hazards for the two treatment arms. The proposed designs are developed by deriving two types of optimum allocation designs, and also by using a distribution function to link the past allocation, covariate and response histories to the present allocation. The optimal designs are based on biased coin procedures, with a bias towards the better treatment arm. These are the doubly-adaptive biased coin design (DBCD) and the efficient randomized adaptive design (ERADE). The treatment allocation proportions for these designs converge to the expected target values, which are functions of the Cox regression coefficients that are estimated sequentially. These expected target values are derived based on constrained optimization problems and are updated as information accrues with sequential arrival of patients. The design based on the link function is derived using the distribution function of a probit model whose parameters are adjusted based on the covariate profile of the incoming patient. To apply such designs, the treatment allocation probabilities are sequentially modified based on the treatment allocation history, response history, previous patients’ covariates and also the covariates of the incoming patient. Given these information, an expression is obtained for the conditional probability of a patient allocation to a treatment arm. Based on simulation studies, it is found that the ERADE is preferable to the DBCD when the main aim is to minimize the variance of the observed allocation proportion and to maximize the power of the Wald test for a treatment difference. However, the former procedure being discrete tends to be slower in converging towards the expected target allocation proportion. The link function based design achieves the highest skewness of patient allocation to the best treatment arm and thus ethically is the best design. Other comparative merits of the proposed designs have been highlighted and their preferred areas of application are discussed. It is concluded that the proposed CARA designs can be considered as suitable alternatives to the traditional balanced randomization designs in survival trials in terms of the power of the Wald test, provided that response data are available during the recruitment phase of the trial to enable adaptations to the designs. Moreover, the proposed designs enable more patients to get treated with the better treatment during the trial thus making the designs more ethically attractive to the patients. An existing clinical trial has been redesigned using these methods.

Keywords: censored response, Cox regression, efficiency, ethics, optimal allocation, power, variability

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Authors: Alexander Winkler, Jozef Suchý

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This paper investigates simple implicit force control algorithms realizable with industrial robots. A lot of approaches already published are difficult to implement in commercial robot controllers, because the access to the robot joint torques is necessary or the complete dynamic model of the manipulator is used. In the past we already deal with explicit force control of a position controlled robot. Well known schemes of implicit force control are stiffness control, damping control and impedance control. Using such algorithms the contact force cannot be set directly. It is further the result of controller impedance, environment impedance and the commanded robot motion/position. The relationships of these properties are worked out in this paper in detail for the chosen implicit approaches. They have been adapted to be implementable on a position controlled robot. The behaviors of stiffness control and damping control are verified by practical experiments. For this purpose a suitable test bed was configured. Using the full mechanical impedance within the controller structure will not be practical in the case when the robot is in physical contact with the environment. This fact will be verified by simulation.

Keywords: robot force control, stiffness control, damping control, impedance control, stability

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Authors: Kotbia Labiod, Mohamed Mouldi Tlili

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The presence of different mineral salts in natural waters may precipitate and form hard deposits in water distribution systems. In this respect, we have developed numerous works on scaling by Algerian water with a very high hardness of 102 °F. The aim of our work is to study the influence of water dynamics and its composition on mineral salts on the precipitation of calcium carbonate (CaCO3). To achieve this objective, we have adopted two precipitation techniques based on controlled degassing of dissolved CO2. This study will identify the causes and provide answers to this complex phenomenon.

Keywords: calcium carbonate, controlled degassing, precipitation, scaling

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Authors: Ciaran Friel, Jerry Suls, Mark Butler, Patrick Robles, Samantha Gordon, Frank Vicari, Karina W. Davidson

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Physical activity guidelines focus on increasing moderate-intensity activity for older adults, but adherence to recommendations remains low. This is despite the fact that scientific evidence supports that any increase in physical activity is positively correlated with health benefits. Behavior change techniques (BCTs) have demonstrated effectiveness in reducing sedentary behavior and promoting physical activity. This pilot study uses a Personalized Trials (N-of-1) design to evaluate the efficacy of using four BCTs to promote an increase in low-intensity physical activity (2,000 steps of walking per day) in adults aged 45-75 years old. The 4 BCTs tested were goal setting, action planning, feedback, and self-monitoring. BCTs were tested in random order and delivered by text message prompts requiring participant engagement. The study recruited health system employees in the target age range, without mobility restrictions and demonstrating interest in increasing their daily activity by a minimum of 2,000 steps per day for a minimum of five days per week. Participants were sent a Fitbit® fitness tracker with an established study account and password. Participants were recommended to wear the Fitbit device 24/7 but were required to wear it for a minimum of ten hours per day. Baseline physical activity was measured by Fitbit for two weeks. In the 8-week intervention phase of the study, participants received each of the four BCTs, in random order, for a two-week period. Text message prompts were delivered daily each morning at a consistent time. All prompts required participant engagement to acknowledge receipt of the BCT message. Engagement is dependent upon the BCT message and may have included recording that a detailed plan for walking has been made or confirmed a daily step goal (action planning, goal setting). Additionally, participants may have been directed to a study dashboard to view their step counts or compare themselves to their baseline average step count (self-monitoring, feedback). At the end of each two-week testing interval, participants were asked to complete the Self-Efficacy for Walking Scale (SEW_Dur), a validated measure that assesses the participant’s confidence in walking incremental distances, and a survey measuring their satisfaction with the individual BCT that they tested. At the end of their trial, participants received a personalized summary of their step data in response to each individual BCT. The analysis will examine the novel individual-level heterogeneity of treatment effect made possible by N-of-1 design and pool results across participants to efficiently estimate the overall efficacy of the selected behavioral change techniques in increasing low-intensity walking by 2,000 steps, five days per week. Self-efficacy will be explored as the likely mechanism of action prompting behavior change. This study will inform the providers and demonstrate the feasibility of an N-of-1 study design to effectively promote physical activity as a component of healthy aging.

Keywords: aging, exercise, habit, walking

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Authors: Mahboobeh Sadeghi, Zahra Izadi Khah, Mansour Hakim Javadi, Masoud Gholamali Lavasani

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Background: Since there is a relation between psychological and physiological factors, the aim of this study was to examine the effect of Emotion Regulation training on cognitive emotion regulation problem in patients with Multiple Sclerosis(MS) Method: In a randomized clinical trial thirty patients diagnosed with Multiple Sclerosis referred to state welfare organization were selected. The sample group was randomized into either an experimental group or a nonintervention control group. The subjects participated in 75-minute treatment sessions held three times a week for 4weeks (12 sessions). All 30 individuals were administered with Cognitive Emotion Regulation questionnaire (CERQ). Participants completed the questionnaire in pretest and post-test. Data obtained from the questionnaire was analyzed using Mancova. Results: Emotion Regulation significantly decreased the Cognitive Emotion Regulation problems patients with Multiple sclerosis (p < 0.001). Conclusions: Emotion Regulation can be used for the treatment of cognitive-emotion regulation problem in Multiple sclerosis.

Keywords: Multiple Sclerosis, cognitive-emotion regulation, emotion regulation, MS

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Authors: Awais Naeem, Osama Shakeel, Aamir Ali Syed, Shahid Khattak

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Introduction: Laparoscopic right hemicolectomy is an advanced cancer surgery in today's era. The aim of this study was to evaluate the surgical and initial oncological outcomes after curative, laparoscopic resection of right sided colonic tumors. Also to compare our results with those of previous randomized trials. Methods And Procedures: We retrospectively analyzed the medical record files of all the patients who presented to our hospital with the diagnosis of right sided colon carcinoma from January 2012 to December 2017 and underwent laparoscopic right hemicolectomy. Demographics, operative findings and histopathological reports were all recorded on a preformed data sheet. All the analysis was performed on SPSS 20. Results: Total of 48 patients were included. There were 37 male and 11 female patients with mean age of 49.7 (range from 25 – 82). Mean hospital stay was 8.25 ± 3.17 days. Blood loss was 80mls and operative mean time was 240 minutes. Eighteen patients had extended right hemicolectomy. Median length of the specimen retrieved was 31cm (range, 14-59cm). Mean size of tumor was 6.44cm + 2.53. Total number of lymph nodes removed was 20.5 + 8.3. All had R0 resection. Post-operatively 2 patients had pelvic collection and there was no 30 day mortality. In 33 patients there was T3 disease, 5 had T2 and 10 had T4 disease. There was distant recurrence in 4 patients with peritoneal metastasis in 3 and liver metastasis in 1 patient. Forty-six patients are still alive and 44 are disease free. The mean follow-up period was 25.31 (12 to 60) months. Conclusion: Our early experience with Laparascopic Right hemicolectomy as a safe and oncologically feasible surgical option. We attained comparable surgical results with curative intent.

Keywords: right hemicolectomy, right sided colonic tumors, laparoscopic, curative intent

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Authors: Dipali Nagaonkar, Mahendra Rai

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Chitosan, a carbohydrate polymer at nanoscale level has gained considerable momentum in drug delivery applications due to its inherent biocompatibility and non-toxicity. However, conventional synthetic strategies for chitosan nanoparticles mainly rely upon physicochemical techniques, which often yield chitosan microparticles. Hence, there is an emergent need for development of controlled synthetic protocols for chitosan nanoparticles within the nanometer range. In this context, we report the green synthesis of size controlled chitosan nanoparticles by using Pongamia pinnata (L.) leaf extract. Nanoparticle tracking analysis confirmed formation of nanoparticles with mean particle size of 85 nm. The stability of chitosan nanoparticles was investigated by zetasizer analysis, which revealed positive surface charged nanoparticles with zeta potential 20.1 mV. The green synthesized chitosan nanoparticles were further explored for encapsulation and controlled release of antioxidant biomolecule, quercetin. The resulting drug loaded chitosan nanoparticles showed drug entrapment efficiency of 93.50% with drug-loading capacity of 42.44%. The cumulative in vitro drug release up to 15 hrs was achieved suggesting towards efficacy of green synthesized chitosan nanoparticles for drug delivery applications.

Keywords: Chitosan nanoparticles, green synthesis, Pongamia pinnata, quercetin

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Authors: Yee Yan Crystal Kwong

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The essence of rape is the absence of consent to sexual intercourse. Yet, the definition of consent is not absolute and allows for subjectivity. In this case, the accuracy of oral interpretation becomes very important as the narratives of events and situation, as well as the register and style of speakers would influence the juror decision making. This paper first adopts a corpus-based approach to investigate how court interpreters in Hong Kong handle expressions that refer to sexual activities. The data of this study will be based on online corpus :From legislation to translation, from translation to interpretation: The narrative of sexual offences. The corpus comprises the transcription of five separate rape trials and all of these trials were heard with the presence of an interpreter. Since there are plenty of sex-related expressions used by witnesses and defendants in the five cases, emphasis will be put on those which have an impact on the definition of rape. With an in-depth analysis of the interpreted utterances, different interpreting approaches will be identified to observe how interpreters retain the intended meanings. Interviews with experienced court interpreters will also be conducted to revisit the validity of the traditional verbatim standard. At the end of this research, various interpreting approaches will be compared and evaluated. A redefinition of interpreters' institutional role, as well as recommendations for interpreting learners will be provided.

Keywords: court interpreting, interpreters, legal translation, slangs

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Authors: Akane Uda, Ami Tabata, Mi An, Misa Komaki, Ryotaro Ito, Mayumi Inoue, Takehiro Sasai, Yusuke Kusano, Toshihiro Kato

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Early intervention is recommended for children with autism spectrum disorder (ASD), and an increasing number of children have received support and intervention before school age in recent years. In this study, we systematically reviewed preschool interventions focused on repetitive behaviors observed in children with ASD, which are often observed at younger ages. Inclusion criteria were as follows : (1) Child of preschool status (age ≤ 7 years) with a diagnosis of ASD (including autism, Asperger's, and pervasive developmental disorder) or a parent (caregiver) with a preschool child with ASD, (2) Physician-confirmed diagnosis of ASD (autism, Asperger's, and pervasive developmental disorder), (3) Interventional studies for repetitive behaviors, (4) Original articles published within the past 10 years (2012 or later), (5) Written in English and Japanese. Exclusion criteria were as follows: (1) Systematic reviews or meta-analyses, (2) Conference reports or books. We carefully scrutinized databases to remove duplicate references and used a two-step screening process to select papers. The primary screening included close scrutiny of titles and abstracts to exclude articles that did not meet the eligibility criteria. During the secondary screening, we carefully read the complete text to assess eligibility, which was double-checked by six members at the laboratory. Disagreements were resolved through consensus-based discussion. Our search yielded 304 papers, of which nine were included in the study. The level of evidence was as follows: three randomized controlled trials (level 2), four pre-post studies (level 4b), and two case reports (level 5). Seven articles selected for this study described the effectiveness of interventions. Interventions for repetitive behaviors in preschool children with ASD were categorized as five interventions that directly involved the child and four educational programs for caregivers and parents. Studies that directly intervened with children used early intensive intervention based on applied behavior analysis (Early Start Denver Model, Early Intensive Behavioral Intervention, and the Picture Exchange Communication System) and individualized education based on sensory integration. Educational interventions for caregivers included two methods; (a) education regarding combined methods and practices of applied behavior analysis in addition to classification and coping methods for repetitive behaviors, and (b) education regarding evaluation methods and practices based on children’s developmental milestones in play. With regard to the neurophysiological basis of repetitive behaviors, environmental factors are implicated as possible contributors. We assumed that applied behavior analysis was shown to be effective in reducing repetitive behaviors because analysis focused on the interaction between the individual and the environment. Additionally, with regard to educational interventions for caregivers, the intervention was shown to promote behavioral change in children based on the caregivers' understanding of the classification of repetitive behaviors and the children’s developmental milestones in play and adjustment of the person-environment context led to a reduction in repetitive behaviors.

Keywords: autism spectrum disorder, early intervention, repetitive behaviors, systematic review

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Authors: Hadriana Bansi, Elizabeth Wina, Toto Toharmat

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Acacia villosa is thornless shrub legume which contents high crude protein. However, the utilization of A. villosa as ruminant feed is limited by its secondary compounds. The aim of this article is to find out the maximum of substitution A. villosa in sheep ration. The nutritional evaluation consisted of in vitro two stages, in vivo, and in vitro gas production trials. The secondary compounds of A. villosa also were analyzed. Evaluating digestibility of increasing level of substitution A. villosa replacing Pennisetum purpureum was using in vitro two stages. The substitution of 30% A. villosa was compared to 100% P. purpureum by in vitro gas production technique and in vivo digestibility. The results of two stages in vitro showed that total phenol, condensed tannin, and non-protein amino acid (NPAA) were high. Substitution 15% A. villosa reached the highest digestibility for both dry matter (DM) and crude protein (CP) which were 67% and 86% respectively, but it was shown that DM and CP digestibility of substitution 30% of A. villosa was still high which were 61.82% and 75-67% respectively. The pattern of gas production showed that first 8 hours total gas production substitution of 30% A. villosa was higher than 100% P. purpureum and declined after 10 hours incubation. In vivo trials showed that substitution of 30% A. villosa significantly increased CP intake, CP digestibility, and nitrogen retention. It can be concluded that substitution A. villosa until 30% still gave the good impact even though it has high secondary compounds.

Keywords: Acacia villosa, digestibility, gas production, secondary compounds

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Authors: Ali Al Moussaoui

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An experiment was designed to assess the performance of 24 Lebanese adults (mean age 29:5 years) in a lexical decision making (LDM) task to find out how the facilitatory effect of phonological priming (PP) affects the speed of visual word recognition in Arabic as lexicality (wordhood) and phonological overlap positions (POP) vary. The experiment falls in line with previous research on phonological priming in the light of the cohort theory and in relation to visual word recognition. The experiment also departs from the research on the Arabic language in which the importance of the consonantal root as a distinct morphological unit is confirmed. Based on previous research, it is hypothesized that (1) PP has a facilitating effect in LDM with words but not with nonwords and (2) final phonological overlap between the prime and the target is more facilitatory than initial overlap. An LDM task was programmed on PsychoPy application. Participants had to decide if a target (e.g., bayn ‘between’) preceded by a prime (e.g., bayt ‘house’) is a word or not. There were 4 conditions: no PP (NP), nonwords priming nonwords (NN), nonwords priming words (NW), and words priming words (WW). The conditions were simultaneously controlled for word length, wordhood, and POP. The interstimulus interval was 700 ms. Within the PP conditions, POP was controlled for in which there were 3 overlap positions between the primes and the targets: initial (e.g., asad ‘lion’ and asaf ‘sorrow’), final (e.g., kattab ‘cause to write’ 2sg-mas and rattab ‘organize’ 2sg-mas), or two-segmented (e.g., namle ‘ant’ and naħle ‘bee’). There were 96 trials, 24 in each condition, using a within-subject design. The results show that concerning (1), the highest average reaction time (RT) is that in NN, followed firstly by NW and finally by WW. There is statistical significance only between the pairs NN-NW and NN-WW. Regarding (2), the shortest RT is that in the two-segmented overlap condition, followed by the final POP in the first place and the initial POP in the last place. The difference between the two-segmented and the initial overlap is significant, while other pairwise comparisons are not. Based on these results, PP emerges as a facilitatory phenomenon that is highly sensitive to lexicality and POP. While PP can have a facilitating effect under lexicality, it shows no facilitation in its absence, which intersects with several previous findings. Participants are found to be more sensitive to the final phonological overlap than the initial overlap, which also coincides with a body of earlier literature. The results contradict the cohort theory’s stress on the onset overlap position and, instead, give more weight to final overlap, and even heavier weight to the two-segmented one. In conclusion, this study confirms the facilitating effect of PP with words but not when stimuli (at least the primes and at most both the primes and targets) are nonwords. It also shows that the two-segmented priming is the most influential in LDM in Arabic.

Keywords: lexicality, phonological overlap positions, phonological priming, visual word recognition

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Authors: Bijad Alqahtani, Graham Arnold, Weijie Wang

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Background—Tai Chi Chuan (TCC) is a type of traditional Chinese martial art and is considered a benefiting physical fitness. Advanced techniques of motion analysis have been routinely used in the clinical assessment. However, so far, little research has been done on the biomechanical assessment of TCC players in terms of gait and balance using motion analysis. Objectives—The aim of this study was to investigate whether TCC improves the lower limb conditions and balance ability using the state of the art motion analysis technologies, i.e. motion capture system, electromyography and force platform. Methods—Twenty TCC (9 male, 11 female) with age between (42-77) years old and weight (56.2-119 Kg), and eighteen Non-TCC participants (7 male, 11 female), weight (50-110 Kg) with age (43- 78) years old at the matched age as a control group were recruited in this study. Their gait and balance were collected using Vicon Nexus® to obtain the gait parameters, and kinematic parameters of hip, knee, and ankle joints in three planes of both limbs. Participants stood on force platforms to perform a single leg balance test. Then, they were asked to walk along a 10 m walkway at their comfortable speed. Participants performed 5 trials of single-leg balance for the dominant side. Also, the participants performed 3 trials of four square step balance and 10 trials of walking. From the recorded trials, three good ones were analyzed using the Vicon Plug-in-Gait model to obtain gait parameters, e.g. walking speed, cadence, stride length, and joint parameters, e.g. joint angle, force, moments, etc. Result— The temporal-spatial variables of TCC subjects were compared with the Non-TCC subjects, it was found that there was a significant difference (p < 0.05) between the groups. Moreover, it was observed that participants of TCC have significant differences in ankle, hip, and knee joints’ kinematics in the sagittal, coronal, and transverse planes such as ankle angle (19.90±19.54 deg) for TCC while (15.34±6.50 deg) for Non-TCC, and knee angle (14.96±6.40 deg) for TCC while (17.63±5.79 deg) for Non-TCC in the transverse plane. Also, the result showed that there was a significant difference between groups in the single-leg balance test, e.g. maintaining single leg stance time in the TCC participants showed longer duration (20.85±10.53 s) in compared to Non-TCC people group (13.39±8.78 s). While the result showed that there was no significant difference between groups in the four square step balance. Conclusion—Our result showed that there are significant differences between Tai Chi Chuan and Non-Tai Chi Chuan participants in the various aspects of gait analysis and balance test, as a consequence of these findings some of biomechanical parameters such as joints kinematics, gait parameters and single leg stance balance test, the Tai Chi Chuan could improve the lower limb conditions and could reduce a risk of fall for the elderly with ageing.

Keywords: gait analysis, kinematics, single leg stance, Tai Chi Chuan

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Authors: Pramote Thangkratok

Abstract:

The aims of this experimental study were to investigate the effect of Reverse Trendelenburg Position on the Back Pain after Cardiovascular Angiography and Interventions. In addition, to compare bleeding and hematoma occurrences at the Access site between experimental and control groups. The randomized controlled trial (RCT) was conducted in 70 patients who underwent Cardiovascular Angiography and Interventions via the femoral artery and received post procedural care at the intermediate cardiac care unit, Bangkok Heart Hospital. From December 2015 to February 2016. The control group (35 patients) was to get standard care after the intervention, whereas the experimental group (35 patients) was Reverse Trendelenburg Position 30-45 degrees. The groups were not significantly different in terms of demographic characteristics, Age, Gender, BMI, blood pressure, heart rate. While not significantly different from each other, the intensity of back pain control group had a significantly higher pain score than experimental group. Vascular complications in terms of bleeding and hematoma were not significantly different between the control and experimental groups. The findings show that Reverse Trendelenburg Position after Cardiovascular Angiography and Interventions would reduce or prevent the back pain without increasing the chance of bleeding and hematoma.

Keywords: reverse trendelenburg position, back pain, cardiovascular angiography, cardiovascular interventions

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Authors: Panagiotis T. Kanellos, Vaios T. Karathanos, Andriana C. Kaliora

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Introduction: The role of ghrelin and obestatin in appetite regulation has been investigated. However, data on ghrelin and obestatin changes after food ingestion are negligible. Objective: We aimed at assessing the appetite-regulating hormones, ghrelin, and obestatin, and furthermore calculate ghrelin/obestatin ratio in healthy normal-weight subjects after consumption of raisins. This survey is a comparative study of a glucose control with raisins containing fructose and glucose in similar concentrations as well as fibers. Methodology: Ten apparently healthy subjects who reported no history of glucose intolerance, diabetes, gastrointestinal disorders, or recent use of any antibiotics were enrolled in the study. The raisins used (Vitis vinifera) originate in Greece and are distributed worldwide as Corinthian raisins. In a randomized crossover design, all subjects after an overnight fast consumed, either 50g of glucose diluted in 240 mL of water (control) or 74 g of raisins (sugar content 50 g) with a 5-day interval between individual trials. Vein blood samples were collected at baseline and at 60, 120 and 180 min postprandially. In blood samples ghrelin and obestatin were measured applying specific enzyme linked immuno absorbent assays. Results: The subjects were of mean age 26.3 years, with BMI of 21.6 kg/m2, waist circumference of 77.7 cm, normal serum lipidemic parameters and normal HbA1c levels. Ghrelin levels were significantly lower after raisin consumption compared to glucose at 120 and at 180 min post-ingestion (p= 0.011 and p= 0.035, respectively). However, obestatin did not reach statistical significance between the two interventions. The ghrelin/obestatin ratio was found significantly lower (p=0.020) at 120 min after raisin ingestion compared to control. Conclusion: Two isocaloric foods containing equal amounts of sugars, however with a different composition, have different effects on appetite hormones ghrelin and obestatin in normal-weight healthy subjects.

Keywords: appetite, ghrelin, obestatin, raisins

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Authors: Christopher Schwarz, Katrin Riegler, Erwin Zinser

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The management of outsourcing relationships between IT service providers and their customers proofs to be a critical issue that has to be stipulated by means of Service Level Agreements (SLAs). Since service requirements differ from customer to customer, SLA content and language structures vary largely, standardized SLA templates may not be used and an automated processing of SLA content is not possible. Hence, SLA management is usually a time-consuming and inefficient manual process. For overcoming these challenges, this paper presents an innovative and ITIL V3-conform approach for automated SLA design and management using controlled natural language in enterprise collaboration portals. The proposed novel concept is based on a self-developed controlled natural language that follows a subject-predicate-object approach to specify well-defined SLA content structures that act as templates for customized contracts and support automated SLA processing. The derived results eventually enable IT service providers to automate several SLA request, approval and negotiation processes by means of workflows and business rules within an enterprise collaboration portal. The illustrated prototypical realization gives evidence of the practical relevance in service-oriented scenarios as well as the high flexibility and adaptability of the presented model. Thus, the prototype enables the automated creation of well defined, customized SLA documents, providing a knowledge representation that is both human understandable and machine processable.

Keywords: automated processing, controlled natural language, knowledge representation, information technology outsourcing, service level management

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Authors: M. Sepahvand, M. Khorushy

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Gladiolus, being a cormous plant, it is principally propagated by the natural multiplication of new corms and cormels. In order to obtain callus from segmented corm which was obtained from in vitro culture, callus formation media were MS media supplemented with 4 levels of hormones such as 1.0 mg l-1 NAA + 0.5 mg l-1 BAP, 0.5 mg l-1 NAA + 0.25 mg l-1 BAP, 1.0 mg l-1 2, 4-D + 0.5 mg l-1 BAP, and 0.5 mg l-1 2, 4-D + 0.25 mg l-1 BAP. The results showed that the most weight of callus (2.28 g) was produced in MS callus formation media which were supplemented with 1.0 mg l-1 NAA + 0.5 mg l-1 BAP. This experiment was carried out in randomized completely design with 3 replications and each treatment with six jars. In second experiment for regeneration of callus, a factorial experiment in the form of randomized complete design with 12 treatments and 3 replications and each replication with six jars was carried out. The treatments consisted of callus culture media in 4 levels and regeneration culture media in 3 levels [control (no PGRs), MS with 0.2 mg l-1 BAP + 0.1 mg l-1 Kin + 0.01 mg l-1 NAA, and MS with 0.2 mg l-1 BAP + 0.05 mg l-1 Kin + 0.01 mg l-1 NAA]. The results showed that the best regeneration media were MS media which were supplemented with 0.2 mg l-1 BAP + 0.1 mg l-1 Kin. + 0.01 mg l-1 NAA that had the highest number of shoots (7/83 N), and shoot length (7/3 cm).

Keywords: regeneration, Segmented corm explant, callus, in vitro, gladiolus cv. white prosperity

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Authors: Jacqueline Y. Thompson, Sam Watson, Lee Middleton, Karla Hemming

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Introduction: The odds ratio (estimated via logistic regression) is a well-established and common approach for estimating covariate-adjusted binary treatment effects when comparing a treatment and control group with dichotomous outcomes. Its popularity is primarily because of its stability and robustness to model misspecification. However, the situation is different for the relative risk and risk difference, which are arguably easier to interpret and better suited to specific designs such as non-inferiority studies. So far, there is no equivalent, widely acceptable approach to estimate an adjusted relative risk and risk difference when conducting clinical trials. This is partly due to the lack of a comprehensive evaluation of available candidate methods. Methods/Approach: A simulation study is designed to evaluate the performance of relevant candidate methods to estimate relative risks to represent conditional and marginal estimation approaches. We consider the log-binomial, generalised linear models (GLM) with iteratively weighted least-squares (IWLS) and model-based standard errors (SE); log-binomial GLM with convex optimisation and model-based SEs; log-binomial GLM with convex optimisation and permutation tests; modified-Poisson GLM IWLS and robust SEs; log-binomial generalised estimation equations (GEE) and robust SEs; marginal standardisation and delta method SEs; and marginal standardisation and permutation test SEs. Independent and identically distributed datasets are simulated from a randomised controlled trial to evaluate these candidate methods. Simulations are replicated 10000 times for each scenario across all possible combinations of sample sizes (200, 1000, and 5000), outcomes (10%, 50%, and 80%), and covariates (ranging from -0.05 to 0.7) representing weak, moderate or strong relationships. Treatment effects (ranging from 0, -0.5, 1; on the log-scale) will consider null (H0) and alternative (H1) hypotheses to evaluate coverage and power in realistic scenarios. Performance measures (bias, mean square error (MSE), relative efficiency, and convergence rates) are evaluated across scenarios covering a range of sample sizes, event rates, covariate prognostic strength, and model misspecifications. Potential Results, Relevance & Impact: There are several methods for estimating unadjusted and adjusted relative risks. However, it is unclear which method(s) is the most efficient, preserves type-I error rate, is robust to model misspecification, or is the most powerful when adjusting for non-prognostic and prognostic covariates. GEE estimations may be biased when the outcome distributions are not from marginal binary data. Also, it seems that marginal standardisation and convex optimisation may perform better than GLM IWLS log-binomial.

Keywords: binary outcomes, statistical methods, clinical trials, simulation study

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Authors: Meetty Tomy, Arxhana G Thosar

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This paper provides the implementation of optimal control for an armature-controlled DC motor. The selection of error weighted Matrix and control weighted matrix in order to implement optimal control theory for improving the dynamic behavior of DC motor is presented. The closed loop performance of Armature controlled DC motor with derived linear optimal controller is then evaluated for the transient operating condition (starting). The result obtained from MATLAB is compared with that of PID controller and simple closed loop response of the motor.

Keywords: optimal control, DC motor, performance index, MATLAB

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Authors: Wenjin Zhu, Ian E. Jacobs, Henning Sirringhaus

Abstract:

We have demonstrated a model system for the controlled incorporation of tie-chains into semicrystalline conjugated polymers using blends of different molecular weights that leads to a significant increase in electrical conductivity. Through careful assessment of the microstructural evolution upon tie chain incorporation we have demonstrated that no major changes in phase morphology or structural order in the crystalline domains occur and that the observed enhancement in electrical conductivity can only be explained consistently by tie chains facilitating the transport across grain boundaries between the crystalline domains. Here we studied the thermoelectric properties of aligned, ion exchange-doped ribbon phase PBTTT with blends of different molecular weight components. We demonstrate that in blended films higher electrical conductivities (up to 4810.1 S/cm), Seebeck coefficients and thermoelectric power factors of up to 172.6 μW m-1 K-2 can be achieved than in films with single component molecular weights. We investigate the underpinning thermoelectric transport physics, including structural and spectroscopic characterization, to better understand how controlled tie chain incorporation can be used to enhance the thermoelectric performance of aligned conjugated polymers.

Keywords: organic electronics, thermoelectrics, conjugated polymers, tie chain

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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: Hamza I. Isa, Gezina C. H. Ferreira, Jan E. Crafford, Christoffel J. Botha

Abstract:

Moraea pallida Bak. (yellow tulip) poisoning is the most important plant-induced cardiac glycoside toxicosis in South Africa. Cardiac glycoside poisonings collectively account for about 33 and 10 % mortalities due to plants, in large and small stock respectively, in South Africa. The toxic principle is 1α, 2α-epoxyscillirosidine, a bufadienolide. The aim of the study was to investigate the potential to develop a vaccine against epoxyscillirosidine. Epoxyscillirosidine and the related bufadienolides proscillaridin and bufalin, which are commercially available, were conjugated to the carrier proteins [Hen ovalbumin (OVA), bovine serum albumin (BSA) and keyhole limpet haemocyanin (KLH)], rendering them immunogenic. Adult male New Zealand White rabbits were immunized. In Trials 1 and 2, rabbits (n=6) were, each assigned to two groups. Experimental animals (n=3; n=4) were vaccinated with epoxyscillirosidine-OVA conjugate, while the control (n=3; n=2) were vaccinated with OVA, using Freund’s complete and incomplete and Montanide adjuvants, for Trials 1 and 2, respectively. In Trial 3, rabbits (n=15), randomly allocated to 5 equal groups (I, II, III, IV and V), were vaccinated with proscillaridin-BSA, bufalin-BSA, epoxyscillirosidine-KLH, epoxyscillirosidine-BSA conjugates, and BSA respectively, using Montanide as adjuvant. Vaccination was on Days 0, 21 and 42. Additional vaccinations were done on Day 56 and 63 for Trial 1. Vaccination was by intradermal injection of 0.4 ml of the immunogen (4 mg/ml [Trial 1] and 8 mg/ml for Trials 2 and Trial 3, respectively). Blood was collected pre-vaccination and at 3 week intervals following each vaccination. Antibody response was determined using an indirect ELISA. There was poor immune response associated with the dose (0.4 mg per rabbit) and adjuvant used in Trial 1. Antibodies were synthesized against the conjugate administered in Trial 2. For Trail 3, antibodies against the immunogens were successfully raised in rabbits with epoxyscillirosidine-KLH inducing the highest immune response. The antibodies raised against proscillaridin and bufalin cross-reacted with epoxyscillirosidine when used as antigen in the ELISA. The study successfully demonstrated the synthesis of antibodies against the bufadienolide conjugates administered. The cross-reactivity of proscillaridin and bufalin with epoxyscillirosidine could potentially be utilized as alternative to epoxyscillirosidine in future studies to prevent yellow tulp poisoning by vaccination.

Keywords: antibodies , bufadienolides, cross-reactivity, epoxyscillirosidine, Moraea pallida, poisoning

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