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Siyoto, Sandu. "Visual Schedule towards the Decline of Behavioral Problems in Feeding Activities and Defecation in Children with Autism." Jurnal NERS 10, no. 2 (October 15, 2015): 250. http://dx.doi.org/10.20473/jn.v10i22015.250-255.
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Introduction: Autism is a pervasive developmental disorder in children that is characterized by the disruption and delays in cognitive, language, behavior, communication and social interaction. One of the ways for children with autism is the visual schedule. Visual schedule is a learning method in the form of information in a visual form that communicates a series of activities. This study aimed to determine the effects of a visual schedule to decrease problem behaviors when feeding activity and defecation in children with autism in the Foundation Board of Christian Education Wetan Jawi (YBPK) Kediri. Method: Research design was One Group Pre Post Test Design, with a population of 30 respondents, used the purposive sampling technique obtained a sample of 16 respondents. When the reseachon April 16 Until Mei 17, 2014. Results: The results showed obtained Asymp significant p = 0.011 <0.05 with Wilcoxon statistical test, which means that HO was rejected and H1 accepted schedule. It means there were visual effects on reducing behavioral problems in feeding activity and defecation in children with autism in the Foundation Board of Christian Education Wetan Jawi (YBPK) Kediri in 2014. Discussion: The Visual schedules can be applied in the treatment of autistic children who have behavior problems, because these techniques can provide influence on autistic children to be able to decrease behavior problems. Keywords: Visual Schedule, decline in behavior problems, children with autism
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Liu, Zheng, and Barry J. Richmond. "Response Differences in Monkey TE and Perirhinal Cortex: Stimulus Association Related to Reward Schedules." Journal of Neurophysiology 83, no. 3 (March 1, 2000): 1677–92. http://dx.doi.org/10.1152/jn.2000.83.3.1677.
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Anatomic and behavioral evidence shows that TE and perirhinal cortices are two directly connected but distinct inferior temporal areas. Despite this distinctness, physiological properties of neurons in these two areas generally have been similar with neurons in both areas showing selectivity for complex visual patterns and showing response modulations related to behavioral context in the sequential delayed match-to-sample (DMS) trials, attention, and stimulus familiarity. Here we identify physiological differences in the neuronal activity of these two areas. We recorded single neurons from area TE and perirhinal cortex while the monkeys performed a simple behavioral task using randomly interleaved visually cued reward schedules of one, two, or three DMS trials. The monkeys used the cue's relation to the reward schedule (indicated by the brightness) to adjust their behavioral performance. They performed most quickly and most accurately in trials in which reward was immediately forthcoming and progressively less well as more intermediate trials remained. Thus the monkeys appeared more motivated as they progressed through the trial schedule. Neurons in both TE and perirhinal cortex responded to both the visual cues related to the reward schedules and the stimulus patterns used in the DMS trials. As expected, neurons in both areas showed response selectivity to the DMS patterns, and significant, but small, modulations related to the behavioral context in the DMS trial. However, TE and perirhinal neurons showed strikingly different response properties. The latency distribution of perirhinal responses was centered 66 ms later than the distribution of TE responses, a larger difference than the 10–15 ms usually found in sequentially connected visual cortical areas. In TE, cue-related responses were related to the cue's brightness. In perirhinal cortex, cue-related responses were related to the trial schedules independently of the cue's brightness. For example, some perirhinal neurons responded in the first trial of any reward schedule including the one trial schedule, whereas other neurons failed to respond in the first trial but respond in the last trial of any schedule. The majority of perirhinal neurons had more complicated relations to the schedule. The cue-related activity of TE neurons is interpreted most parsimoniously as a response to the stimulus brightness, whereas the cue-related activity of perirhinal neurons is interpreted most parsimoniously as carrying associative information about the animal's progress through the reward schedule. Perirhinal cortex may be part of a system gauging the relation between work schedules and rewards.
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Ma, Guofeng, and Xiaoye Liu. "Model and Algorithm for Dependent Activity Schedule Optimization Combining with BIM." Advances in Civil Engineering 2020 (August 30, 2020): 1–14. http://dx.doi.org/10.1155/2020/9727256.
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The project duration can be shortened by overlapping construction activities. However, the continuous changing of the environment tends to cause problems such as rework and the failure of the overlapping plan. In order to solve these problems, communication strategies for the overlapping of dependent activities are first introduced and optimized from a revenue perspective. We first consider the different maturities of upstream activity before and after the overlapping, the downstream sensitivity which is decided by involving communication strategies, and the learning and error-correcting ability of workers. Then, the overlap and communication strategies are decided by calculating the maximum revenue using Monte Carlo simulation and MATLAB based on overlap cost, communication cost, rework cost, and reward amount. Finally, the algorithm and BIM are combined to provide a visual overlap plan and dynamic control platform framework. This research is valuable for practitioners as it provides a dynamic overlap plan which can maximize the revenue in changing the environment and ensure the duration of the project. This research also provides researchers a new insight into combining overlap problems and BIM technology.
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Breslin, Casey M., and Mary E. Rudisill. "The Effect of Visual Supports on Performance of the TGMD-2 for Children With Autism Spectrum Disorder." Adapted Physical Activity Quarterly 28, no. 4 (October 2011): 342–53. http://dx.doi.org/10.1123/apaq.28.4.342.
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The purpose of this study was to examine the effects of visual supports on the performance of the Test of Gross Motor Development (TGMD-2) for children with autism spectrum disorder (ASD). Participants (N = 22) performed the TGMD-2 under three different protocols (traditional protocol, picture task card protocol, and picture activity schedule protocol). Gross motor quotient scores on the TGMD-2 were measured and statistically analyzed using a within-subjects repeated-measures ANOVA. Results indicated statistically significant differences between protocols, while post hoc tests indicated that the picture task card condition produced significantly higher gross motor quotient scores than the traditional protocol and the picture activity schedule. The results suggest that more accurate gross motor quotient scores on the TGMD-2 by children with ASD can be elicited using the picture task card protocol.
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Rothacker, Andrew, Chad W. Cummings, Katherine Tullio, Alison Ibsen, Emily Elizabeth Monteleone, and Rebecca Bottles. "Decreasing time to treat using visual management tools." Journal of Clinical Oncology 36, no. 30_suppl (October 20, 2018): 277. http://dx.doi.org/10.1200/jco.2018.36.30_suppl.277.
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277 Background: Time between positive cancer diagnosis and first treatment (TTT) has lengthened significantly nationwide over the last decade. Decreased TTT has been shown to positively impact patient outcomes such as anxiety and stress, and in some situations, overall survival (OS). As such, TTT (measured in median days) is a major initiative for disease programs at our large academic medical center. Impacting TTT is challenging given the usual sources of data, which are retrospective. Further, engaging the teams around the data was difficult. The need to illustrate patient delays in real-time was identified. Methods: A patient database was created, along with a dashboard, using a visual software package to track patient activity. Information is extracted from the database into a dashboard, including the patient’s appointments, treatments, and barriers to care. The dashboard was constructed with graphics of historical TTT by month, TTT distribution by treatment type, TTT by provider, and a graphic of the most common barriers to treatment. Additionally, the dashboard identified patients who were not scheduled for treatment, and were represented by a symbol on an x/y-axis graph. The x-axis represents the unique patient, while the y-access represents the days from diagnosis, with the symbol incrementing each day the treatment is not scheduled. Results: The dashboard is used weekly to huddle with clinical and non-clinical teams. Patients with no scheduled treatment are easily identifiable on the dashboard, with a focus on minimizing all patient’s TTT. Patients with extended schedule are actively engaged to reschedule and reduce their TTT. The breast cancer program began using the dashboard in July 2017. The surgical TTT was 30 days (n = 34). Post-implementation of the dashboard and multi-disciplinary huddles, it was found in April 2018 the TTT was 26 days (n = 36). Conclusions: Combining real-time data with simple data visualization tools allows teams to identify barriers to care easily. The visual tools identify outliers and allow teams to communicate on scheduling challenges of each patient. In conjunction with the multi-disciplinary huddles, the dashboard allows teams to track progress of each patient to ensure timely scheduling and coordination.
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Bouret, Sebastien, and Barry J. Richmond. "Relation of Locus Coeruleus Neurons in Monkeys to Pavlovian and Operant Behaviors." Journal of Neurophysiology 101, no. 2 (February 2009): 898–911. http://dx.doi.org/10.1152/jn.91048.2008.
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Noradrenaline is released throughout the forebrain from locus coeruleus (LC) projections in close temporal proximity to emotional and goal-directed events. To examine interactive influences of these processes on LC neuronal activity, we used a task where Pavlovian and operant processes vary and can be easily identified. We recorded 69 single LC neurons from two monkeys performing a task where cues indicate the progression through schedules of one, two, or three operant trials. Pavlovian responses and phasic LC activations occur following the appearance of conditioned visual cues (54/69 neurons), especially those at the beginning of new schedules, whether the current trial will be rewarded (single trial schedule) or not (2 or 3 trial schedules), and after visual imperative signals eliciting the operant response (64/69 neurons), whether the current trial will be rewarded or not. The modulation of LC responses seems to be relatively independent of attention or motivation, because the responses do not covary with operant performance in the task. The magnitude of LC responses across the schedules varied in close relation to the intensity of Pavlovian behavior but these responses were also modulated by operant processes. Our conclusion is that LC activation occurs when task-relevant stimuli evoke a conditioned instinctive (Pavlovian) response, with the strength of the activation also being modulated by goal-directed processes. Thus locus coeruleus neurons broadcast information about stimulus-elicited primitive and goal-directed behaviors to forebrain structures important for executive functions and emotions.
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Mizuhiki, Takashi, Barry J. Richmond, and Munetaka Shidara. "Encoding of reward expectation by monkey anterior insular neurons." Journal of Neurophysiology 107, no. 11 (June 1, 2012): 2996–3007. http://dx.doi.org/10.1152/jn.00282.2011.
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The insula, a cortical brain region that is known to encode information about autonomic, visceral, and olfactory functions, has recently been shown to encode information during reward-seeking tasks in both single neuronal recording and functional magnetic resonance imaging studies. To examine the reward-related activation, we recorded from 170 single neurons in anterior insula of 2 monkeys during a multitrial reward schedule task, where the monkeys had to complete a schedule of 1, 2, 3, or 4 trials to earn a reward. In one block of trials a visual cue indicated whether a reward would or would not be delivered in the current trial after the monkey successfully detected that a red spot turned green, and in other blocks the visual cue was random with respect to reward delivery. Over one-quarter of 131 responsive neurons were activated when the current trial would (certain or uncertain) be rewarded if performed correctly. These same neurons failed to respond in trials that were certain, as indicated by the cue, to be unrewarded. Another group of neurons responded when the reward was delivered, similar to results reported previously. The dynamics of population activity in anterior insula also showed strong signals related to knowing when a reward is coming. The most parsimonious explanation is that this activity codes for a type of expected outcome, where the expectation encompasses both certain and uncertain rewards.
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Bowman, E. M., T. G. Aigner, and B. J. Richmond. "Neural signals in the monkey ventral striatum related to motivation for juice and cocaine rewards." Journal of Neurophysiology 75, no. 3 (March 1, 1996): 1061–73. http://dx.doi.org/10.1152/jn.1996.75.3.1061.
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1. The results of neuropsychological, neuropharmacological, and neurophysiological experiments have implicated the ventral striatum in reward-related processes. We designed a task to allow us to separate the effects of sensory, motor, and internal signals so that we could study the correlation between the activity of neurons in the ventral striatum and different motivational states. In this task, a visual stimulus was used to cue the monkeys as to their progress toward earning a reward. The monkeys performed more quickly and with fewer mistakes in the rewarded trials. After analyzing the behavioral results from three monkeys, we recorded from 143 neurons from two of the monkeys while they performed the task with either juice or cocaine reward. 2. In this task the monkey was required to release its grip on a bar when a small visual response cue changed colors from red (the wait signal) to green (the go signal). The duration of the wait signal was varied randomly. The cue became blue whenever the monkey successfully responded to the go signal within 1 s of its appearance. A reward was delivered after the monkey successfully completed one, two, or three trials. The schedules were randomly interleaved. A second visual stimulus that progressively brightened or dimmed signaled to the monkeys their progress toward earning a reward. This discriminative cue allowed the monkeys to judge the proportion of work remaining in the current ratio schedule of reinforcement. Data were collected from three monkeys while they performed this task. 3. The average reaction times became faster and error rates declined as the monkeys progressed toward completing the current schedule of reinforcement and thereby earning a reward, whereas the modal reaction time did not change. As the duration of the wait period before the go signal increased, the monkeys reacted more quickly but their error rates scarcely changed. From these results we infer that the effects of motivation and motor readiness in this task are generated by separate mechanisms rather than by a single mechanism subserving generalized arousal. 4. The activity of 138 ventral striatal neurons was sampled in two monkeys while they performed the task to earn juice reward. We saw tonic changes in activity throughout the trials, and we saw phasic activity following the reward. The activity of these neurons was markedly different during juice-rewarded trials than during correctly performed trials when no reward was forthcoming (or expected). The responses also were weakly, but significantly, related to the proximity of the reward in the schedules requiring more than one trial. 5. The monkeys worked to obtain intravenous cocaine while we recorded 62 neurons. For 57 of the neurons, we recorded activity while the monkeys worked in blocks of trials during which they self-administered cocaine after blocks during which they worked for juice. Although fewer neurons responded to cocaine than to juice reward (19 vs. 33%), this difference was not significant. The neuronal response properties to cocaine and juice rewards were independent; that is, the responses when one was the reward one failed to predict the response when the other was the reward. In addition, the neuronal activity lost most of its selectivity for rewarded trials, i.e, the activity did not distinguish nearly as well between cocaine and sham rewards as between juice and sham rewards. 6. Our results show that mechanisms by which cocaine acts do not appear to be the same as the ones activated when the monkeys were presented with an oral juice reward. This finding raises the intriguing possibility that the effects of cocaine could be reduced selectively without blocking the effects of many natural rewards.
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Ulfa, Maria. "Pembelajaran PAKEM Berbasis Media Audio Visual Gerak dalam Melatih Konsentrasi Belajar Anak di TPA Sahabat Hati Pontianak." AL-ATHFAL : JURNAL PENDIDIKAN ANAK 5, no. 1 (June 27, 2019): 53–68. http://dx.doi.org/10.14421/al-athfal.2019.51-04.
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Early age is an important age to influence subsequent developments. Early childhood is a period of play as a way of learning children. One model of learning in early childhood is PAKEM learning (Active, Creative, Effective and Enjoyable Learning). The purpose of this study is to present PAKEM learning based on audio-visual motion media in training children's learning concentration. The method used is qualitative descriptive with data collection techniques in the form of interviews, observation and documentation. In analyzing the data, it used the Miles and Huberman model. The validity test of the data used source and technique triangulation. The results showed that PAKEM learning based on audio visual motion in the TPA Sahabat Hati was carried out through several stages, namely, planning, implementation and evaluation. The implementation is an initial activity, core and closing. Audio visual motion is displayed via television which is arranged according to the learning schedule. Children then are active to see, hear and follow their movements directly. Thus, PAKEM learning based on audio-visual motion media at the TPA Sahabat Hati is effective in training children's learning concentration.
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Rohani, Mohammad, Gholamali Shafabakhsh, Abdolhosein Haddad, and Ehsan Asnaashari. "Strategy management of construction workspaces by conflict resolution algorithm and visualization model." Engineering, Construction and Architectural Management 25, no. 8 (September 17, 2018): 1053–74. http://dx.doi.org/10.1108/ecam-08-2016-0183.
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Purpose The spatial conflicts and congestion of construction resources are challenges that lead to the reduction in efficiency. The purpose of this paper is to enable users to detect and resolve workspace conflicts by implementing four resolution strategies in a five-dimensional (5D) CAD model. In addition to resolving conflicts, the model should be able to optimize time and cost of the projects. In other words, three variables of spatial conflicts, time and cost of project are considered simultaneously in the proposed model to find the optimum solution. Design/methodology/approach In the first step, a 5D simulation model is developed that includes time, cost and geometrical information of a project. Then, time-cost trade-off analysis was carried out to distinguish optimum schedule. The schedule was imported to the 5D CAD model to detect spatial conflicts. Finally, a novel algorithm was implemented to solve identified conflicts while imposing minimum project’s time and cost. Several iterations are performed to resolve all clashes using conflict resolution algorithm and visual simulation model. Findings The proposed methodology in this research was applied to a real case. Results showed that in comparison to the normal and initial schedule with 19 conflicts, the finalized schedule has no conflict, while time and cost of the project are both reduced. Research limitations/implications Implementing the proposed methodology in construction projects requires proper technical basis in this field. In this regard, the executive user should have a proper understanding of the principles, concepts and tools of building information modeling and have project management knowledge. Also, the implementation conditions of the basic model requires the determination of the construction methods, estimated volumes of working items, scheduling and technical specification. The designed methodology also has two limitations regarding to its implementation. The first is the fact that strategies should be applied manually to the schedule. The other one pertains to the number of strategies used in the research. Four strategies have been used in the conflict resolution algorithm directly and the two others (spatial divisibility and activities breakdown strategies) have been used as default strategies in the visual simulation model. Since the unused strategies including the changing of construction method and the activity resources are subjective and depend upon the planner and project manager’s personal opinion, the authors have avoided using them in this research. Practical implications The method proposed in this research contributes the coordination of the working teams at the planning and execution phases of the project. In fact, the best location and work direction for each working team is presented as a schedule, so that the space conflict may not come about and the cost can be minimized. This visual simulation not only deepens the planners’ views about the executive barriers and the spatial conditions of the worksite, it also makes the construction engineers familiar on a daily basis with their executive scope. Therefore, it considerably improves the interactions and communication of the planning and construction teams. Another advantage and application of this methodology is the use of initial and available projects’ documents including the schedule and two-dimensional drawings. The integration of these basic documents in this methodology helps identify the spatial conflicts efficiently. To achieve this, the use of the existing and widely-used construction tools has facilitated the implementation of the methodology. Using this system, planners have applied the strategies in an order of priority and can observe the results of each strategy visually and numerically in terms of time, cost and conflicts. This methodology by providing the effective resolution strategies guides the practitioner to remove conflicts while optimum time and cost are imposed to project. Originality/value Contrary to the previous models that ignore cost, the proposed model is a 5D visual simulation model, which considers the variable of cost as a main factor for conflict identification and resolution. Moreover, a forward-pass approach is introduced to implement resolution strategies that are novel compared to other investigations.
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Yanagitani, Noriko, Atsushi Horiike, Satoru Kitazono, Fumiyoshi Ohyanagi, Shunsuke Kondo, Akihiko Shimomura, Yutaka Fujiwara, et al. "First-in-human phase I study of an oral HSP90 inhibitor, TAS-116, in advanced solid tumors." Journal of Clinical Oncology 35, no. 15_suppl (May 20, 2017): 2546. http://dx.doi.org/10.1200/jco.2017.35.15_suppl.2546.
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2546 Background: TAS-116 is an oral non-ansamycin, non-purine, and non-resorcinol highly selective inhibitor of HSP90α/β. The objective of this FIH study was to determine the MTD and investigate the safety, tolerability, PK, PD (HSP70 protein levels in PBMCs), and antitumor activity of TAS-116. Methods: The study is being conducted in Japan and the UK. Patients with advanced solid tumors received escalating doses of TAS-116 once daily (QD) with an accelerated titration design. After the MTD was determined, safety and tolerability of 5 days on / 2 days off per week administration (QDx5) at the MTD in QD was explored. In parallel, the MTD with every other day administration (QOD) was evaluated by using a 3 + 3 design. Results: As of 20 September 2016, 52 patients were enrolled. TAS-116 was evaluated at doses of 4.8 to 150.5 mg/m2/day in the QD schedule and doses of 107.5 to 295.0 mg/m2/day in the QOD schedule. The MTD was 107.5 mg/m2/day with QD and 210.7 mg/m2/day with QOD. QDx5 at the MTD in QD using a flat dose of 160 mg was evaluated. The most common adverse events in all regimens were gastrointestinal disorders and increased creatinine. DLTs were observed in 4 patients in QD (night blindness, visual disorder, AST/ ALT/gamma-GTP elevations, and anorexia) and in 2 patients in QOD (platelet count decreased, febrile neutropenia, pneumonia, respiratory failure, and septic shock). Reversible eye disorders were observed in all schedules, but those observed in QDx5 were limited to grade 1. The PK level demonstrated dose proportionality without unexpected accumulation under repeated administration. Dose-related HSP70 induction of PBMCs was observed. As of 20 September 2016, three confirmed durable PRs by RECIST were observed (239 days in GIST and 173 days in NSCLC with QD; 293 + days in NSCLC with QOD). PR and SD ≥ 12 weeks were observed in 15 out of 47 patients. Conclusions: TAS-116 had an acceptable safety profile under all schedules, especially QDx5. Preliminary antitumor activity was demonstrated with evidence of target engagement. Dose expansion at the MTD in this phase 1 study and the phase 2 study in patients with GIST are ongoing. Parts of this study will be expanded to the US with an amended study protocol. Clinical trial information: NCT02965885.
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Nasution, Dewi Sahara, and Faiz Rafdhi. "Sistem Informasi Kegiatan Penunjang Akademik Mahasiswa Berbasis Desktop." Jurnal CoSciTech (Computer Science and Information Technology) 1, no. 2 (October 31, 2020): 65–75. http://dx.doi.org/10.37859/coscitech.v1i2.2192.
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As science and technology have grown, the role and use of information technology has become important. In creation of the book activities on the campus of the Jakarta high school administration of information and computers that have been carried out each year, there are some problems with the data of the activities being carried out and the list of students who have followed the activities that have been carried out, so the certificates and schedule of the activities are ineffective and efficient. In constructing student information-support information system at the Jakarta high school for information management and computers muhammadiyah using Visual Basic (vb.net) as the language oh this program and mysql as database. The system development uses the waterfall model with the step-by-step analysis, design system, coding and testing, implementation and maintenance. The study produced a student’a educational information system that could facilitate the activity data input processstudents can be done quickly, accurately and efficiently. The built system may show student’s overall data, which consists of a list of activities, activity activity times, and activities that have been followed.
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Obrusnikova, Iva, Albert R. Cavalier, Haley M. Novak, Ashleigh E. Blair-McKinsey, and Rick R. Suminski. "Effects of a Community-Based Familiarization Intervention on Independent Performance of Resistance-Training Exercise Tasks by Adults With Intellectual Disability." Intellectual and Developmental Disabilities 59, no. 3 (May 24, 2021): 239–55. http://dx.doi.org/10.1352/1934-9556-59.3.239.
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Abstract Adults with intellectual disability (ID) have significantly lower levels of fitness compared to the general population. The study examined the effects of a multicomponent familiarization intervention, consisting of a visual activity schedule and a video-enhanced system of least-to-most prompting, both displayed via an iPad, on the acquisition of resistance-training exercise tasks by adults with ID, aged 18–44 years, in a community fitness center. Twelve participants were randomly allocated to an experimental group (EG) and 12 to an active control group (CG). ANOVA revealed EG correctly and independently performed a significantly greater number of steps of four resistance-training exercise tasks compared with CG, relative to preintervention levels (p < .01). The intervention was effective in promoting functional performance of resistance-training exercise tasks among adults with ID.
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Premereur, Elsie, Wim Vanduffel, and Peter Janssen. "Local Field Potential Activity Associated with Temporal Expectations in the Macaque Lateral Intraparietal Area." Journal of Cognitive Neuroscience 24, no. 6 (June 2012): 1314–30. http://dx.doi.org/10.1162/jocn_a_00221.
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Oscillatory brain activity is attracting increasing interest in cognitive neuroscience. Numerous EEG (magnetoencephalography) and local field potential (LFP) measurements have related cognitive functions to different types of brain oscillations, but the functional significance of these rhythms remains poorly understood. Despite its proven value, LFP activity has not been extensively tested in the macaque lateral intraparietal area (LIP), which has been implicated in a wide variety of cognitive control processes. We recorded action potentials and LFPs in area LIP during delayed eye movement tasks and during a passive fixation task, in which the time schedule was fixed so that temporal expectations about task-relevant cues could be formed. LFP responses in the gamma band discriminated reliably between saccade targets and distractors inside the receptive field (RF). Alpha and beta responses were much less strongly affected by the presence of a saccade target, however, but rose sharply in the waiting period before the go signal. Surprisingly, conditions without visual stimulation of the LIP-RF-evoked robust LFP responses in every frequency band—most prominently in those below 50 Hz—precisely time-locked to the expected time of stimulus onset in the RF. These results indicate that in area LIP, oscillations in the LFP, which reflect synaptic input and local network activity, are tightly coupled to the temporal expectation of task-relevant cues.
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Handajani, Rinawati Pudji, and Rizky H. Pramesti. "Mapping the Motion Space of Children in Autism Treatment Center of Malang City with TEACCH Approach (Treatment and Education of Autistic and Related Communication Handicapped Children)." Review of Urbanism and Architectural Studies 18, no. 1 (June 30, 2020): 64–72. http://dx.doi.org/10.21776/ub.ruas.2020.018.01.6.
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The Autism Treatment Center in Malang City applies structured teaching-learning methods, namely the TEACCH approach (Treatment and Education of Autistic and Related Communication Handicapped Children) with four essential components: physical structure, schedule, work system, and visual structure. The four components are interrelated with each other so that the goal of helping the development of autistic children can be achieved. The physical structure is the first step to encourage the interest of autistic children. An excellent physical arrangement of space can minimize the tantrum effect of autistic children. Thus, this paper aims to research the space for autistic children with the TEACCH approach. This study used behavioral mapping in the form of person-centered mapping, place centered mapping, and physical trace that aims to determine the pattern of activity, furniture layout, and trace activities of autistic children during therapy activities. The results show the motion space mapping of autistic children.
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Brockington, IF, A. Roper, M. Buckley, J. Copas, C. Andrade, P. Wigg, A. Farmer, C. Kaufman, R. Hawley, and HY Meltzer. "Bipolar disorder, cycloid psychosis and schizophrenia: a study using “lifetime” psychopathology ratings, factor analysis and canonical variate analysis." European Psychiatry 6, no. 5 (1991): 223–36. http://dx.doi.org/10.1017/s0924933800003850.
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SummaryIn an empirical study on the classification of the psychoses, 302 patients were rated using the Longitudinal Psychopathology Schedule. The data were condensed by factor analysis, which yielded 10 factors - mania and schizomania, depression and suicidal activity, and 6 factors concerned with psychotic symptoms (verbal hallucinosis/passivity, delusion formation, defect symptoms, social decline, cycloid symptomatology and a factor loading depressive auditory hallucinations and visual hallucinations). Provisional diagnostic groups were obtained using DSM III. Discriminant function analyses showed that the only clearly distinct diagnostic group was bipolar disorder, and this was true for various definitions. Canonical variate analyses were performed using 3- and 4-criterion groups. These showed that a group corresponding approximately to cycloid psychosis also met criteria for being a distinct group. The most detailed examination pf the data, using 4-criterion groups and serial reclassification, suggested that the psychoses might fall into 5 groups - bipolar disorder, cycloid psychosis, depression, defect states and schizoaffective depression.
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Advani, Ranjana, Andres Forero-Torres, Richard R. Furman, Joseph D. Rosenblatt, Anas Younes, Brooke Shankles, Kate Harrop, and Jonathan G. Drachman. "SGN-40 (Anti-huCD40 mAb) Monotherapy Induces Durable Objective Responses in Patients with Relapsed Aggressive Non-Hodgkin’s Lymphoma: Evidence of Antitumor Activity from a Phase I Study." Blood 108, no. 11 (November 16, 2006): 695. http://dx.doi.org/10.1182/blood.v108.11.695.695.
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Abstract CD40 is a member of the TNF receptor family and is widely expressed on B-cell malignancies. SGN-40 is a humanized antibody against CD40 with effector cell function and partial agonistic activity. Based on potent in vitro and in vivo preclinical activity, a multi-institutional, multi-dose phase I study was conducted to test the safety, pharmacokinetic properties, immunogenicity, and antitumor activity of intravenous SGN-40 in patients with relapsed NHL. Patients with multiple histologic subtypes of NHL were enrolled on this study, including diffuse large B-cell (DLBCL; 14), follicular (FCL; 9), mantle cell (MCL; 9), marginal zone (MZL; 2) and small lymphocytic (SLL; 1). After dose-dependent inflammatory symptoms were identified following the first infusion of SGN-40 in a separate phase I study (i.e. cytokine release syndrome, including headache, fever, muscle aches), this study was modified such that patients were treated with a dose-loading schedule: 1 mg/kg of SGN-40 on day 1 and day 4 and subsequent intra-patient dose-escalation during weeks 2–5 to a maximum dose of 3, 4, 6, or 8 mg/kg over four cohorts. Subsequently, a rapid dose-loading schedule was tested in one cohort (40% increase in total SGN-40 administered during cycle 1). Responding patients or those with stable disease were eligible for a second cycle, consisting of four consecutive weekly infusions at the cohort-specific maximum dose of SGN-40. Most adverse events were grade 1 or 2 and included fatigue (31%), headache (26%), chills (17%), pyrexia (17%), elevated hepatic transaminases (11%), and hypotension (11%). Transient drug-related grade 3 adverse events included conjunctivitis and unilateral loss of visual acuity, anemia, and elevated hepatic transaminases, each in a single patient. There was no difference in the incidence or severity of adverse events at higher doses of SGN-40 nor was there a difference in the safety profiles of the gradual vs. rapid dose-loading schedules. Ten of 35 enrolled patients received a second cycle of treatment without any evidence of cumulative toxicity. No immune responses against SGN-40 have been detected among 16 NHL patients tested to date. Preliminary pharmacokinetic parameters are similar to those seen in preclinical toxicity studies. Durable objective responses have been observed in heavily pre-treated patients. Eight patients with DLBCL completed cycle 1 and received a maximum dose of at least 3 mg/kg SGN-40 with an objective response rate of 37.5% (i.e. 1 CR and 2 PR) and 2 SD. Additional objective responses were seen in one patient with MCL (CR) and one patient with MZL (PR). The median duration of response for these 5 patients has not yet been reached (range 8–37 weeks). Analyses are ongoing to evaluate the role of CD40 expression levels and the relationship of FcγR polymorphisms to response. In conclusion, SGN-40 has favorable safety data and encouraging antitumor activity. A phase II study of single-agent SGN-40 in patients with relapsed DLBCL is planned.
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GOLDER, JOHN. "Molière and the Circumstances of Late Seventeenth-Century Rehearsal Practice." Theatre Research International 33, no. 3 (October 2008): 250–62. http://dx.doi.org/10.1017/s0307883308003957.
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There is precious little documentary evidence regarding the way in which Molière and his company went about preparing themselves for performance in seventeenth-century Paris. After all, rehearsal has always been by definition an intensely private activity. However, in respect of his last play, Le Malade imaginaire, we are more fortunate, for a number of documents exist to illuminate for us if not the rehearsals themselves, at least their circumstances. They are, mostly, mémoires submitted by company suppliers, for lighting and heating and the like. Together with La Grange's Registre, a daily performance calendar, these give us some idea of the complex logistical operation that was the preparation of a comédie-ballet. Comparison of Molière's schedule with that of Préville, his comic counterpart a century later, suggests that – at least as an actor – his time for both study and group preparation was considerably less intense than for the actors of the Comédie-Française a hundred years later.
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Forero-Torres, A., R. R. Furman, J. D. Rosenblatt, A. Younes, K. Harrop, J. G. Drachman, and R. Advani. "A humanized antibody against CD40 (SGN-40) is well tolerated and active in non-Hodgkin’s lymphoma (NHL): Results of a phase I study." Journal of Clinical Oncology 24, no. 18_suppl (June 20, 2006): 7534. http://dx.doi.org/10.1200/jco.2006.24.18_suppl.7534.
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7534 Background: CD40 is a member of the TNF receptor family and is widely expressed on hematologic malignancies of B-cell origin. SGN-40 is a humanized antibody against CD40 with effector cell function and mild agonistic activity. Preclinical toxicity studies and efficacy data supported initiation of a multi-institutional phase I study to test the safety, pharmacokinetics, immunogenicity, and efficacy of SGN-40 in patients with relapsed NHL. Methods: Cohorts of 3–6 pts were treated weekly with a maximum dose of 2, 3, or 4 mg/kg/wk SGN-40. A dose escalation schedule is used such that patients receive 1 mg/kg on D1 and D4, 2 mg/kg on D8, and higher doses on weeks 3–5. Responding patients may receive a second cycle. Further dose escalation up to 8 mg/kg is planned. Results: 16 pts have been treated with multiple histologic subtypes: follicular (1), marginal zone (MZL; 1), mantle cell (4), and diffuse large B-cell (DLBCL; 10). One patient (2 mg/kg) developed a reversible Grade 3 unilateral conjunctivitis and ipsilateral loss of visual acuity. No other dose limiting toxicity has been observed up to 4 mg/kg. Preliminary pharmacokinetic data suggest that the antibody has a relatively short half-life, perhaps reflecting a route of elimination or binding that is not saturated at current doses. Two partial responses have been observed at 3 mg/kg (1 MZL, 1 DLBCL) and one partial response has been observed at 4 mg/kg dose (DLBCL relapsed after autologous stem cell transplant with small volume tumor). Conclusions: Using an intra-patient dose escalation schedule, SGN-40 has been well-tolerated at doses up to 4 mg/kg/wk. Further dose-escalation is ongoing to determine the maximum tolerated dose. Three objective responses have been seen, including two in patients with extensively treated aggressive disease. Correlative studies are underway measuring soluble CD40, cytokine release, effect of FcR polymorphisms, and SGN-40-induced immunogenicity. Given the favorable tolerability and activity, phase II studies in NHL are planned. [Table: see text]
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Johnson ; Roni Sugiarto, Javier. "DYNAMICS CONNECTION OF SOUNDSCAPE WITH ARCHITECTURAL ELEMENTS CASE STUDY: THE SEVEN SORROWS OF VIRGIN SAINT MARY CHURCH." Riset Arsitektur (RISA) 3, no. 03 (July 5, 2019): 240–57. http://dx.doi.org/10.26593/risa.v3i03.3334.240-257.
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Abstract- Nowadays, spatial experience still plays important role in the making of the good quality of architectural spaces. The experience of the space is a multi-sensory experience, so architecture should emphasize its attention not only to visual experience but also other experience like auditory experience. The study was conducted to determine the dynamics connection of soundscape experience and The Seven Sorrows of Virgin Saint Mary Church, Pandu Street, Bandung.The research method is qualitative and descriptive analysis. The analysis is done through questionnaire distribution, field observation, analysis, and by relating it with the study of theories about church architecture, soundscape, sense of place, intention of architecture, and perception theory.In The Seven Sorrows Of Virgin Saint Mary Church are found quite a lot of source of noise which are considered as sounds that decline the quality of the people spatial experience. The noise sounds that are found there are the sound of airplane, motor vehicle, and many more. Those noises can disturb the praying activity. This indicates that there are some architectural elements that have not been able to work optimally. It can be the material, activity settings, building and site shape or character. Furthermore, relation between activity schedule and noises climax will be analized.Through design that concern in the multi-sensory aspects of experience, especially in auditory experience, the experience of space can be felt thoroughly and the quality of a public space can be increased. Key Words: Soundscape, Architectural Elements, Church, The Seven Sorrows of Virgin Saint Mary Church
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Aleksander, Igor. "Artificial intelligence for production engineering: a historical approach." Robotica 5, no. 2 (April 1987): 99–110. http://dx.doi.org/10.1017/s026357470001506x.
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SUMMARYThis paper describes the principles of the advanced programming techniques often dubbed Artificial Intelligence involved in decision making as may be of some value in matters related to production engineering. Automated decision making in the context of production can adopt many aspects. At the most obvious level, a robot may have to plan a sequence of actions on the basis of signals obtained from changing conditions in its environment. These signals may, indeed, be quite complex, for example the input of visual information from a television camera.At another level, automated planning may be required to schedule the entire work cycle of a plant that includes many robots as well as other types of automated machinery. The often-quoted dark factory is an example of this, where not only some of the operations (such as welding) are done by robots, but also the transport of part-completed assemblies is automatically scheduled as a set of actions for autonomic transporters and cranes. It is common practice for this activity to be preprogrammed to the greatest detail. Automated decision making is aimed at adding flexibility to the process so that it can absolve the system designer from having to forsee every eventuality at the design stage.Frequent reference is made in this context to artificial intelligence (AI), knowledge-based and expert systems. Although these topics are more readily associated with computer science, it is the automated factory, in general, and the robot, in particular, that will benefit from success in these fields. In this part of the paper we try to sharpen up this perspective, while in part II we aim to discuss the history of artificial intelligence in this context. In part III we discuss the industrial prospects for the field.
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Westhovens, René, Kristien Van der Elst, Ann Matthys, Michelle Tran, and Isabelle Gilloteau. "Sleep Problems in Patients with Rheumatoid Arthritis." Journal of Rheumatology 41, no. 1 (December 1, 2013): 31–40. http://dx.doi.org/10.3899/jrheum.130430.
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Objective.To investigate sleep problems, and the relationship between sleep and disease activity, in Belgian patients with established rheumatoid arthritis (RA).Methods.This cross-sectional, observational, multicenter study assessed sleep quality using the Athens Insomnia Scale (AIS) and Pittsburgh Sleep Quality Index (PSQI), and daytime sleepiness using the Epworth Sleepiness Scale (ESS). Additional patient-reported outcomes included visual analog scales (VAS) for fatigue and pain, the Medical Outcomes Study Short Form-36 Health Survey, the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the Positive and Negative Affect Schedule. Multivariate regression and structural equation modeling identified factors associated with sleep quality, with the 28-joint Disease Activity Score [DAS28-C-reactive protein (CRP)] as a continuous or categorical variable. Analyses were performed on the total population and on patients stratified by disease activity status: remission/low (DAS28-CRP ≤ 3.2) or moderate to high (DAS28-CRP > 3.2).Results.Among 305 patients, mean (SD) age was 57.00 (12.38) years and mean (SD) disease duration was 11.77 (9.94) years. Mean (SD) AIS, PSQI, and ESS scores were 6.8 (4.79), 7.8 (4.30), and 7.3 (4.67), respectively. Mean (SD) VAS fatigue, VAS pain, and HAQ-DI were 45.22 (26.29), 39.04 (26.21), and 1.08 (0.75), respectively. There were significant positive relationships between DAS28-CRP and AIS/PSQI, but a significant negative relationship between DAS28-CRP and ESS. Several potentially confounding factors were identified.Conclusions.Poor control of RA is associated with a reduction in sleep quality and decreased daytime sleepiness, which is likely explained by pain-related alertness. Future prospective studies are needed to confirm potential relationships between sleep quality, sleepiness, and RA treatment.
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Mould, Diane R., Kevin Sweeney, Stephen Duffull, Ellen Neylon, and Owen A. O’Connor. "A Population Pharmacokinetic and Pharmacodynamic Evaluation of Pralatrexate in Patients with Hematologic Malignancies." Blood 110, no. 11 (November 16, 2007): 1370. http://dx.doi.org/10.1182/blood.v110.11.1370.1370.
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Abstract Pralatrexate is a novel antifol designed to have high affinity for the reduced folate carrier, exhibiting improved internalization over other analogues. Phase 2 and subsequent Phase 1 studies revealed that patients with lymphoma exhibited a higher incidence of mucositis, compared to that reported in patients with solid tumors. The initial Phase 2 experiences employed dose escalation on an every other week schedule (135 to 240 mg/m2 QOW) while the follow-on Phase 1 and 2 studies employed a weekly dosing schedule (30 to 45 mg/m2 weekly for 6 of 7 weeks). The maximum tolerated dose (MTD) was 30 mg/m2 weekly for 6 of 7 weeks in lymphoma patients. Preliminary population pharmacokinetic (PK) and adverse event (AE) evaluations suggested that pralatrexate exposure could be controlled with weight or body size based dosing, and that pretreatment with folic acid and vitamin B12 could abrogate the mucositis. PK and AE data from 47 patients were evaluated using NONMEM Version V level 1.1. Model building followed standard approaches. The best PK model was a three compartment linear model, fitted to the natural log-transformed concentration versus time data. Patient weight and methylmalonic acid (MMA) were found to be predictive of inter-patient PK variability, supporting weight or body surface area (BSA) based dosing. There are observations of an apparent association between MMA concentrations and PDX PK which need to be further explored. The PK model was evaluated using bootstrapping and a visual predictive check. An ordered categorical logistic regression was conducted to evaluate the relationship between pralatrexate exposure and grade of mucositis. In this evaluation, pralatrexate area under the curve (AUC) and MMA were found to be predictive of toxicity, where patients with higher MMA or AUC had a higher probability of mucositis. Individualized dosing combined with vitamin pretreatment significantly improved the toxicity profile, allowing for a shift in the dose-limiting toxicity (DLT) from mucositis to thrombocytopenia. Although the data from the present study were limited, the covariates identified in the population PK and adverse event evaluations were comparable with those identified for other anti-folate agents. MMA is a sensitive indicator of vitamin B12 deficiency and its impact on toxicity is commonly reported for this class of agents. The rationale behind the influence of MMA on clearance is less clear and may be correlated with other aspects of patient health. Pralatrexate has exhibited promising activity in patients with chemotherapy refractory peripheral T-cell lymphoma, leading now to an international multi-center Phase 2 study in peripheral T-cell lymphoma. The application of a population PK model based analysis was a critical component in the development of this agent. Model-based evaluations allowed the identification of the safest schedules and supported the need for vitamin supplementation for the safe administration.
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Aziz Ismail, Nemat Ismail Abdel, and Wafaa Taha Ibrahim Elgzar. "The Effect of Progressive Muscle Relaxation on Post Cesarean Section Pain, Quality of Sleep and Physical Activities Limitation." International Journal of Studies in Nursing 3, no. 3 (July 30, 2018): 14. http://dx.doi.org/10.20849/ijsn.v3i3.461.
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Background: Pain, sleep disturbances, and physical activity limitation are the most tiresome complains of the women post caesarian section (Cs). Progressive muscle relaxation is a promising intervention for these complains. This study aimed to determine the effect of progressive muscle relaxation technique on post-cesarean section pain, quality of sleep and physical activities limitation. Research design: Randomized controlled clinical trial. Setting: post-partum unit at Damanhour National Medical Institute. Sample: A purposive sample of 80 women undergoing Cs was recruited. Randomization block was done to randomly assign 40 women for the study group and 40 for the control group. Tools: Four tools were used for data collection: structured interview schedule, short-form McGill Pain Questionnaire, Physical activities limitation Questionnaire and Groningen Sleep Quality Scale. Results: After the intervention, PMR significantly decreased pain severity among study group in Pain Rating Index scale, Visual analogue pain scale, and Present Pain Intensity scale compared to the control group. The severe physical activities limitation significantly absent from the entire study group, while it was significantly present among 70% of the control group. About two-thirds (62.5%) of the study group had a good quality of sleep compared to 5% of the control group. Conclusion: PMR significantly decreased pain, improved physical activities and quality of sleep among women after Cs. Recommendation: PMR should be incorporated in the nursing intervention protocols post-Cs.
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Rowles, Susannah V., L. Prieto, X. Badia, Steven M. Shalet, Susan M. Webb, and Peter J. Trainer. "Quality of Life (QOL) in Patients with Acromegaly Is Severely Impaired: Use of a Novel Measure of QOL: Acromegaly Quality of Life Questionnaire." Journal of Clinical Endocrinology & Metabolism 90, no. 6 (June 1, 2005): 3337–41. http://dx.doi.org/10.1210/jc.2004-1565.
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Acromegaly Quality of Life Questionnaire (AcroQoL) is a new disease-generated quality of life (QOL) questionnaire comprising 22 questions covering physical and psychological aspects of acromegaly and subdivided into “appearance” and “personal relations” categories. We have performed a cross-sectional study of QOL in 80 patients [43 male (mean age, 54.2 yr; range, 20–84); median GH, 0.93ng/ml (range, <0.3 to 23.7); IGF-I, 333.1 ng/ml (range, 47.7–899)] with acromegaly. In addition to AcroQoL, patients completed three generic QOL questionnaires: Psychological General Well-Being Schedule (PGWBS), EuroQol, and a signs and symptoms score (SSS). All three generic questionnaires confirmed impairment in QOL [mean scores: PGWBS, 69.6; EuroQol, visual analog scale, 66.4 (range, 20–100) and utility index, 0.7 (range, −0.07 to 0.92); and SSS, 12 (range, 0–27)]. There was no correlation between biochemical control and any measure of QOL. AcroQoL (57.3%; range, 18.2–93.2) correlated with PGWBS (r = 0.73; P < 0.0001); and in patients with active disease, AcroQoL-physical dimension correlated with SSS (r = −0.67; P < 0.0003). In all questionnaires, prior radiotherapy was associated with impaired QOL. In conclusion, these data underline the marked impact that acromegaly has on patients’ QOL and provide the first evidence validating AcroQoL against well-authenticated measures of QOL. This indicates the potential of AcroQoL as a patient-friendly measure of disease activity.
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Kasina, I. V., S. A. Alekseeva, and T. I. Nemirovskaya. "Theoretical and Experimental Substantiation of Alternative Methods for Quality Control of Live Anthrax Vaccine." BIOpreparations. Prevention, Diagnosis, Treatment 20, no. 4 (December 14, 2020): 277–84. http://dx.doi.org/10.30895/2221-996x-2020-20-4-277-284.
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Preventive immunisation against anthrax is carried out in accordance with the national Immunisation Schedule for Epidemic Settings. The vaccination is performed using a live vaccine—a freeze-dried suspension of Bacillus anthracis STI-1 vaccine strain spores in a stabilizing media. Improvement of the quality control of immunobiological medicines is a pressing issue and an integral part of the quality management system.The aim of study was to streamline quality control of live anthrax vaccine in terms of the following test parameters: identification and specific activity (total spore concentration).Materials and methods: identification and specific activity (total spore concentration) tests were performed for samples of live anthrax vaccine, batch 266, produced by the 48 Central Scientific Research Institute. The identification test was performed using the B. anthracis immunochromatography test kit for express detection and identification of anthrax pathogen spores produced by the State Research Center for Applied Microbiology and Biotechnology (Obolensk). The specific activity (total spore concentration) was assessed by the visual method and calculated in the Goryaev chamber using the industry reference standard of bacterial suspension turbidity equivalent to 10 IU—OSO 42-28-85 (by the Scientific Centre for Expert Evaluation of Medicinal Products). The number of live spores in live anthrax vaccine was determined by the microbiological method (by inoculating media). The statistical processing of the results was performed using Excel and Statistica 10.0.Results: the authors provided theoretical and experimental substantiation to support the feasibility of using immunochromatography as an alternative identification test method for live anthrax vaccine. Test samples dilutions of 108 microbial cells per millilitre and 109 microbial cells per millilitre are used in the test. The authors developed a test procedure for determination of the total spore concentration (specific activity) in live anthrax vaccine using an industry reference standard of turbidity equivalent to 10 IU, and proposed a formula for calculation of the total spore concentration.Conclusions: the developed test procedures could be recommended for inclusion in the live anthrax vaccine specification files as alternative methods of quality control.
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AbouRizk, Simaan M., and Anil Sawhney. "Subjective and interactive duration estimation." Canadian Journal of Civil Engineering 20, no. 3 (June 1, 1993): 457–70. http://dx.doi.org/10.1139/l93-060.
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Scheduling of construction projects with an uncertainty content requires that the scheduler's subjective knowledge of various factors that might influence the duration of the activities comprising the project is incorporated. Depending on the participating factors and their significance, a different duration outcome is often observed for each activity. To include this uncertainty in the schedule, a statistical distribution is frequently used. This paper presents a system based on the premise that part of the information available, when duration distribution is being estimated, exists in a subjective form. We present an automated system that requires the modeler to specify the activity's minimum and maximum times and a set of linguistic descriptors of the external factors that are suspect of influencing the duration. The lower and upper end point estimates are often available from familiarity with the technology used, physical and logical constraints, or a combination of these situations. The subjective information collected by the modeler is modeled as fuzzy parameters and is quantified using fuzzy set theory. The result of the fuzzy set analysis is a sample of activity durations from the underlying distribution, which is then used to characterize the first two moments of that distribution. Since earlier research has shown that the beta distribution provides an adequate representation for construction durations, the end points specified by the user and the two moments resulting from the fuzzy set analysis are used to fit a beta distribution. The system then allows the user to visually assess the quality of the fit and modify the shape of the beta density using the visual interactive beta estimation system. The paper also presents a practical construction scheduling application to demonstrate the use of the developed system. Key words: construction management, scheduling, fuzzy sets, subjective duration estimation, beta distribution, linguistic variables.
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Ramón, Fidel, Oscar H. Hernández, and Theodore H. Bullock. "Event-related potentials in an invertebrate: crayfish emit ‘omitted stimulus potentials’." Journal of Experimental Biology 204, no. 24 (December 15, 2001): 4291–300. http://dx.doi.org/10.1242/jeb.204.24.4291.
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SUMMARY Electrical signs of neural activity correlated with stimuli or states include a subclass called event-related potentials. These overlap with, but can often be distinguished from, simple stimulus-bound evoked potentials by their greater dependence on endogenous (internal state) factors. Studied mainly in humans, where they are commonly associated with cognition, they are considered to represent objective signs of moderately high-level brain processing. We tested the hypothesis that invertebrates lack such signs by looking in the crayfish Procambarus clarkii for a class of OFF-effects shown in humans to index expectancy. Disproving the hypothesis, we find, using chronic, implanted preparations, that a good omitted stimulus potential is reliably present. The system learns in a few cycles of a regularly repeated light flash to expect one on schedule. Omitted stimulus potentials are found in the protocerebrum, the circumesophageal connective and in the optic tract – perhaps arising in the retina, as in vertebrates. These potentials can be very local and can include loci with and without direct visual evoked potentials in response to each flash. In some loci, the omitted stimulus potential has a slow wave component, in others only a spike burst. Omitted stimulus potentials are more endogenous than visual evoked potentials, with little dependence on flash or ambient light intensity or on train duration. They vary little in size at different times of the day, but abruptly fail to appear if the ambient light is cut off. They can occur during walking, eating or the maintained defense posture but are diminished by ‘distraction’ and are often absent from an inert crayfish until it is aroused. We consider this form of apparent expectation of a learned rhythm (a property that makes it ‘cognitive’ in current usage), to be one of low level, even though some properties suggest endogenous factors. The flashes in a train have an inhibitory effect on a circuit that quickly ‘learns’ the stimulus interval so that the omitted stimulus potential, ready to happen after the learned interval, is prevented by each flash, until released by a missing stimulus.
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Kasina, I. V., S. A. Alekseeva, and T. I. Nemirovskaya. "Prospects for Improving Quality Evaluation of the Live Brucellosis Vaccine in Terms of Specific Activity." BIOpreparations. Prevention, Diagnosis, Treatment 20, no. 2 (June 26, 2020): 126–35. http://dx.doi.org/10.30895/2221-996x-2020-20-2-126-135.
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Prophylactic immunisation against brucellosis is part of the National Immunisation Schedule for Epidemic Settings. The immunisation is performed with a live vaccine—a lyophilized suspension of the Brucella abortus strain 19 BА in a stabilizing medium. The paper presents the results of quality evaluation of 9 batches of live brucellosis vaccine that were submitted to the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality of the Federal State Budgetary Institution “Scientific Centre for Expert Evaluation of Medicinal Products” of the Ministry of Health of the Russian Federation for assessment of the product’s compliance with the established specifications. The paper also presents the results of evaluation of the passport information provided by the manufacturer for these batches. There is no doubt about the need for objective quality evaluation of brucellosis vaccines as well as about the significance of its improvement.The aim of study was to assess the prospects for improving quality evaluation of live brucellosis vaccines in terms of Specific activity (concentration of microbial cells, number of living microbial cells, number of cutaneous doses).Materials and methods: specific activity (concentration of microbial cells and number of living microbial cells) was determined by visual and microbiological methods using the industrial reference standard of brucellosis vaccine OSO 42-28-396-2018, batch 6 and the bacterial suspension of the Brucella abortus strain 19 BА acquired from the joint stock company Scientific and Production Association “Microgen” in 2016. The number of cutaneous doses in the brusellosis vaccine was determined by the calculation method. Statistical processing of the results was performed using Microsoft Excel.Results: there was a mismatch between the brucella concentration coefficient of 1.7×109 microbial cells/mL determined by comparison with the industrial reference standard of bacterial suspension turbidity, 10 IU and the actual concentration of microbial cells obtained in the study. According to preliminary results, the brucella concentration coefficient corresponding to the industrial reference standard of bacterial suspension turbidity, 10 IU can reach 3.0×109 microbial cells/mL.Conclusions: the obtained results can serve as a basis for amending the data on the brucella concentration coefficient in the Passport and the Instructions for use of the industrial reference standard of bacterial suspension turbidity, 10 IU, as well as the Specific activity section (concentration of microbial cells, number of living microbial cells, number of cutaneous doses) of the established specifications for the brucellosis vaccine. Before amending the information on the brucella concentration corresponding to 10 IU in the Passport and the Instructions for use of the reference standard of bacterial suspension turbidity (OSO 42-28-85P), additional studies should be performed with other types of brucella.
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Aamodt, Sandra M., Jian Shi, Matthew T. Colonnese, Wellington Veras, and Martha Constantine-Paton. "Chronic NMDA Exposure Accelerates Development of GABAergic Inhibition in the Superior Colliculus." Journal of Neurophysiology 83, no. 3 (March 1, 2000): 1580–91. http://dx.doi.org/10.1152/jn.2000.83.3.1580.
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Maturation of excitatory synaptic connections depends on the amount and pattern of their activity, and activity can affect development of inhibitory synapses as well. In the superficial visual layers of the superior colliculus (sSC), developmental increases in the effectiveness of γ-aminobutyric acid (GABAA) receptor–mediated inhibition may be driven by the maturation of visual inputs. In the rat sSC, GABAAreceptor currents significantly jump in amplitude between postnatal days 17 and 18( P17 and P18), approximately when the effects of cortical inputs are first detected in collicular neurons. We manipulated the development of these currents in vivo by implanting a drug-infused slice of the ethylene-vinyl acetate copolymer Elvax over the superior colliculus of P8 rats to chronically release from this plastic low levels of N-methyl-d-aspartate (NMDA). Sham-treated control animals received a similar implant containing only the solvent for NMDA. To examine the effects of this treatment on the development of GABA-mediated neurotransmission, we used whole cell voltage-clamp recording of spontaneous synaptic currents (sPSCs) from sSC neurons in untreated, NMDA-treated, and sham-treated superior colliculus slices ranging in age from 10 to 20 days postnatal. Both amplitude and frequency of sPSCs were studied at holding potentials of +50 mV in the presence and absence of the GABAA receptor antagonist, bicuculline methiodide (BMI). The normal developmental increase in GABAA receptor currents occurred on schedule ( P18) in sham-treated sSC, but NMDA treatment caused premature up-regulation ( P12). The average sPSCs in early NMDA-treated neurons were significantly larger than in age-matched sham controls or in age-matched, untreated neurons. No differences in average sPSC amplitudes across treatments or ages were present in BMI-insensitive, predominantly glutamatergic synaptic currents of the same neurons. NMDA treatment also significantly increased levels of glutamate decarboxylase (GAD), measured by quantitative western blotting with staining at P13 and P19. Cell counting using the dissector method for MAP 2 and GAD67 at P13 and P19indicated that the differences in GABAergic transmission were not due to increases in the proportion of inhibitory to excitatory neurons after NMDA treatment. However, chronic treatments begun at P8 with Elvax containing both NMDA and BMI significantly decreased total neuron density at P19 (∼15%), suggesting that the NMDA-induced increase in GABAA receptor currents may protect against excitotoxicity.
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Heist, Rebecca Suk, Leena Gandhi, Geoffrey Shapiro, Naiyer A. Rizvi, Howard A. Burris, Johanna C. Bendell, Jose Baselga, et al. "Combination of a MEK inhibitor, pimasertib (MSC1936369B), and a PI3K/mTOR inhibitor, SAR245409, in patients with advanced solid tumors: Results of a phase Ib dose-escalation trial." Journal of Clinical Oncology 31, no. 15_suppl (May 20, 2013): 2530. http://dx.doi.org/10.1200/jco.2013.31.15_suppl.2530.
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2530 Background: PI3K/mTOR and MAPK signaling pathways are often deregulated in tumors. Simultaneous inhibition of these pathways with the MEK1/2 inhibitor, pimasertib, plus the dual PI3K/mTOR inhibitor, SAR245409, (ClinicalTrials.gov NCT01390818) was investigated. Methods: This was a phase Ib, modified 3+3, dose-escalation trial in patients (pts) with advanced solid tumors. Pts received pimasertib and SAR245409 at the following dose levels (DLs): DL1, 15/30; DL2a, 30/30; DL2b, 15/50; DL3, 30/50; DL4a, 60/50; DL4b, 30/70; DL5, 60/70; DL6a, 90/70; DL6b 60/90 and DL7, 90/90 mg (once-daily, qd). After the qd maximum tolerated dose (MTD) was established, twice-daily (bid) dosing was tested: DL1a, 60/30; DL1b, 45/50 and DL2 60/50 mg bid. A recommended phase II dose (RP2D) was determined. Enrollment continued at the RP2D in four expansion cohorts (18 pts each): dual KRAS/PIK3CA mutated (mt) colorectal cancer (CRC), triple-negative breast cancer, KRAS mt non-small cell lung cancer (NSCLC) and BRAFmt melanoma. Results: 53 pts were treated qd and 7 pts bid. The most common tumors were CRC (n=16), NSCLC (n=8), ovarian and pancreatic (n=7, each). At DL6b 2/3 pts had dose-limiting toxicities (DLTs; both grade [Gr] 3 nausea/vomiting). DL6a was confirmed as the MTD for the qd schedule. At bid DL1a 2/4 pts (both Gr 3 skin rash) and at DL1b 2/3 pts (Gr 3 skin rash and Gr 3 asthenia) had DLTs. DL5 was the RP2D based on tolerability after prolonged exposure. The most common adverse events in qd schedule were: rash (62%, 13% Gr 3), diarrhea (56%, 4% Gr 3), fatigue (51%, 2% Gr 3), nausea (49%, 2% Gr 3), vomiting (45%, 2% Gr 3), peripheral edema and pyrexia (34%, each) and visual impairment with underlying serous retinal detachment (21%). Preliminary pharmacokinetic results suggest no drug-drug interaction. There were 4 partial responses: KRAS mt CRC (n=1) and low-grade ovarian cancer (n=3, 1 KRAS mt/PIK3CA mt and 2 wild-type). Enrollment in expansion cohorts at DL5 is ongoing. Conclusions: Continuousqd dosing of pimasertib and SAR245409 is tolerated and has shown signs of activity. Phase II trials are being planned. Clinical trial information: NCT01390818.
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Zimmerman, Kathleen N., Jennifer R. Ledford, and Erin E. Barton. "Using Visual Activity Schedules for Young Children With Challenging Behavior." Journal of Early Intervention 39, no. 4 (August 14, 2017): 339–58. http://dx.doi.org/10.1177/1053815117725693.
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Jakacki, Regina I., Bruce H. Cohen, Cheryl Jamison, Vincent P. Mathews, Edward Arenson, Darryl C. Longee, Joanne Hilden, et al. "Phase II evaluation of interferon α-2a for progressive or recurrent craniopharyngiomas." Journal of Neurosurgery 92, no. 2 (February 2000): 255–60. http://dx.doi.org/10.3171/jns.2000.92.2.0255.
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Object. Craniopharyngiomas originate from the same cells as squamous cell skin carcinoma, which can be treated successfully with interferon-α (IFNα)-2a. The authors evaluated the activity and toxicity of systemic IFN in young patients with craniopharyngiomas.Methods. Fifteen patients between the ages of 4.2 and 19.8 years who had progressive or recurrent craniopharyngiomas were enrolled in this study. Nine of these patients had never received external-beam radiation therapy. Therapy consisted of 8,000,000 U/m2 IFNα-2a administered daily for 16 weeks (induction phase) followed by the same dose three times per week for an additional 32 weeks (maintenance phase). Of the 12 patients who could be evaluated, radiological studies demonstrated a response to treatment in three with predominantly cystic tumors (one minor response, one partial response, and one complete response); one of these patients also showed improvement in visual fields. The size of the cystic component of the tumors often increased temporarily during the first several months of therapy. Three patients met the criteria for progressive disease during therapy. The median time to progression was 25 months. The need for radiation therapy in patients treated with IFN was delayed for 18 to 35 months (median 25 months) in six patients. All patients developed transient flulike symptoms shortly after receiving the first dose of IFN. Other toxicities (predominantly hepatic, neurological, and cutaneous) were seen in nine (60%) of the 15 patients during the first 8 weeks of treatment but resolved after temporary discontinuation and/or dose reduction.Conclusions. Interferon-α-2a is active against some childhood craniopharyngiomas; its toxicity precludes administration of high daily doses, and the optimum dose level and schedule remain to be defined.
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Moniruzzaman, Mahammed, Kazi Nurul Hasan, and Saumen Kumar Maitra. "Melatonin actions on ovaprim (synthetic GnRH and domperidone)-induced oocyte maturation in carp." REPRODUCTION 151, no. 4 (April 2016): 285–96. http://dx.doi.org/10.1530/rep-15-0391.
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The major objective of the present study was to demonstrate the actions of exogenous melatonin on ovaprim (synthetic GnRH and domperidone)-induced final oocyte maturation focusing on the oxidative status of pre-ovulatory follicles in the carpCatla catla. Accordingly, gravid carp during the early spawning phase of the reproductive cycle were injected with melatonin and/or ovaprim at different time intervals or luzindole (a pharmacological blocker of melatonin receptors) before their administration. We studied their effects on the latency period, the rate of germinal vesicle breakdown (GVBD; a visual marker of final oocyte maturation) in oocytes, and the levels of maturation-promoting factor (MPF), as well as oxidative stress, different antioxidants, melatonin and MT1 melatonin receptor protein in the extracts of pre-ovulatory follicles. Notably, melatonin treatment 2 h before the injection of ovaprim resulted in the shortest latency period as well as the highest rate of GVBD and MPF formation. Exogenous melatonin, irrespective of the injection schedule, caused a significant reduction in intra-follicular oxidative stress and an increase in the levels of both enzymatic and non-enzymatic antioxidants, melatonin and its receptor protein. Concentrations of ovarian melatonin in each fish exhibited a significant negative correlation with the level of oxidative stress, but a positive correlation with the rate of GVBD and the activity/level of different antioxidants. However, no significant effects of melatonin and/or ovaprim were detected in luzindole-pretreated carp. Collectively, the present study provides the first evidence that melatonin pretreatment in carp ameliorates ovaprim actions on the process of final oocyte maturation by the formation of MPF and alleviates oxidative stress in pre-ovulatory follicles by stimulating different antioxidants.
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Qu, Liang, Shunnan Ge, Nan Li, Wei Wang, Kaijun Yang, Ping Wu, Xuelian Wang, and Jie Shi. "Clinical evaluation of deep brain stimulation of nucleus accumbens/anterior limb of internal capsule for opioid relapse prevention: protocol of a multicentre, prospective and double-blinded study." BMJ Open 9, no. 2 (February 2019): e023516. http://dx.doi.org/10.1136/bmjopen-2018-023516.
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IntroductionDeep brain stimulation (DBS) is a new potential surgical treatment for opioid dependence. However, the implement of DBS treatment in addicted patients is currently controversial due to the significant associated risks. The aim of this study was mainly to investigate the therapeutic efficacy and safety of bilateral DBS of nucleus accumbens and the anterior limb of the internal capsule (NAc/ALIC-DBS) in patients with refractory opioid dependence (ROD).Methods and analysis60 patients with ROD will be enrolled in this multicentre, prospective, double-blinded study, and will be followed up for 25 weeks (6 months) after surgery. Patients with ROD (semisynthetic opioids) who meet the criteria for NAc/ALIC-DBS surgery will be allocated to either the early stimulation group or the late stimulation group (control group) based on the randomised ID number. The primary outcome was defined as the abstinence rate at 25 weeks after DBS stimulation on, which will be confirmed by an opiate urine tests. The secondary outcomes include changes in the Visual Analogue Scale (VAS) score for craving for opioid drugs, body weight, as well as psychological evaluation measured using the 17-item Hamilton Depression Rating Scale, the Hamilton Anxiety Rating Scale, the Pittsburgh Sleep Quality Index, Fagerstrom test for nicotine dependence assessment, social disability screening schedule, the Activity of Daily Living Scale, the 36-item Short Form-Health Survey and safety profiles of both groups.Ethics and disseminationThe study received ethical approval from the medical ethical committee of Tangdu Hospital, The Fourth Military Medical University, Xi’an, China. The results of this study will be published in a peer-reviewed journal and presented at international conferences.Trial registration numberNCT03424616; Pre-results.
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Spriggs, Amy D., Victoria Knight, and Lauren Sherrow. "Talking Picture Schedules: Embedding Video Models into Visual Activity Schedules to Increase Independence for Students with ASD." Journal of Autism and Developmental Disorders 45, no. 12 (November 21, 2014): 3846–61. http://dx.doi.org/10.1007/s10803-014-2315-3.
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Dang, Nam H., Peter McLaughlin, Luis Fayad, Jorge Romaguera, Fredrick Hagemeister, Anas Younes, Sattva Neelapu, et al. "Interim Analysis of a Phase II Study of the Combination of Denileukin Diftitox (Ontak) and Rituximab for Relapsed/Refractory B-Cell Non-Hodgkin’s Lymphoma." Blood 106, no. 11 (November 16, 2005): 3349. http://dx.doi.org/10.1182/blood.v106.11.3349.3349.
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Abstract Denileukin diftitox (ONTAK, Ligand Pharmaceuticals) is a genetically engineered fusion protein comprising the enzymatically active domain of diphtheria toxin and the full length sequence of interleukin-2 (IL-2) that targets malignancies expressing the IL-2 receptor. The drug has established efficacy in cutaneous T-cell lymphoma and we have previously reported its clinical activity in patients with recurrent B-cell Non-Hodgkin’s Lymphomas (B-NHL) (Dang et al. J Clin Oncol22:4095–4102, 2004). Given the significant activity of rituximab and the non-cross-resistant mechanism of action, we initiated a phase II study at MD Anderson Cancer Center to evaluate the efficacy of the combination of denileukin diftitox and rituximab in relapsed/refractory B-NHL. Patients were required to have prior exposure to rituximab, absolute neutrophil count ≥ 1000/uL, platelets ≥ 40,000/uL, serum creatinine ≤ 1.5 mg/dL, serum albumin ≥ 3.0 g/dL. Rituximab was given as an IV infusion at a dose of 375 mg/m2 on day one of each cycle. Denileukin diftitox was given at a dose schedule of 18 mcg/kg/day by IV infusion once daily for 5 days on days 2–6 of each cycle. Cycles were repeated every 3 weeks. Restaging evaluation of response was performed after every 2 cycles. Patients with stable disease or objective response were allowed to continue until a maximum of 8 cycles. Premedications (corticosteroids, antihistamines and fluids) were given prior to each drug infusion to decrease the risk and severity of acute hypersensitivity reactions. Thirty-three patients have been entered to date, with 30 being evaluable for toxicity and 28 for response. Median age was 67 (range 47–82), and median number of previous treatment was 4 (range 1–9). Among patients evaluable for response, there were 10 cases of diffuse large cell lymphoma (DLCL), 9 cases of follicular lymphoma (FL), 3 cases of transformed lymphoma from FL (T-FL), 3 cases of mantle cell lymphoma (MCL), 2 cases of small lymphocytic lymphoma (SLL), and 1 case of marginal zone lymphoma (MZL). Twenty patients (71%) were refractory to prior treatment with rituximab. The overall response rate was 32% with 3 CR (11%, 2 FL, 1 T-FL) and 6 PR (21%, 3 FL, 1 T-FL, 1 MCL, 1 SLL). Eight patients (29%) had stable disease. All responders but one had disease refractory to previous rituximab treatment and one CR occurred in a patient who had failed 4 prior treatments that included autologous transplantation. Five of the 9 responders had CD25 + histologies. Median time to progression for responders was 6 months, with the 3 CRs still ongoing at 14+, 10+ and 8+ months. Grade 3–4 toxicities were uncommon and included fatigue 9%, fever 6% and infection 6%. Two patients experienced visual changes; one patient had transient changes and has fully recovered, and the other has residual effects. The patient left with residual effects completed 8 cycles and obtained a CR The etiology of these visual changes is unknown. We conclude that the novel combination of denileukin diftitox and rituximab has significant clinical activity in this heavily pretreated population, with toxicities that can be managed with premedications and close monitoring. Accrual is ongoing.
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Narendra, Ajay, Samuel F. Reid, Birgit Greiner, Richard A. Peters, Jan M. Hemmi, Willi A. Ribi, and Jochen Zeil. "Caste-specific visual adaptations to distinct daily activity schedules in Australian Myrmecia ants." Proceedings of the Royal Society B: Biological Sciences 278, no. 1709 (October 6, 2010): 1141–49. http://dx.doi.org/10.1098/rspb.2010.1378.
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Animals are active at different times of the day and their activity schedules are shaped by competition, time-limited food resources and predators. Different temporal niches provide different light conditions, which affect the quality of visual information available to animals, in particular for navigation. We analysed caste-specific differences in compound eyes and ocelli in four congeneric sympatric species of Myrmecia ants, with emphasis on within-species adaptive flexibility and daily activity rhythms. Each caste has its own lifestyle: workers are exclusively pedestrian; alate females lead a brief life on the wing before becoming pedestrian; alate males lead a life exclusively on the wing. While workers of the four species range from diurnal, diurnal-crepuscular, crepuscular-nocturnal to nocturnal, the activity times of conspecific alates do not match in all cases. Even within a single species, we found eye area, facet numbers, facet sizes, rhabdom diameters and ocelli size to be tuned to the distinct temporal niche each caste occupies. We discuss these visual adaptations in relation to ambient light levels, visual tasks and mode of locomotion.
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Patnaik, Amita, Patricia LoRusso, Howard A. Ball, Erkut Bahceci, Geoffrey Yuen, Kyriakos P. Papadopoulos, Muaiad Kittaneh, and Anthony W. Tolcher. "Pharmacokinetics and safety of an oral ALK inhibitor, ASP3026, observed in a phase I dose escalation trial." Journal of Clinical Oncology 31, no. 15_suppl (May 20, 2013): 2602. http://dx.doi.org/10.1200/jco.2013.31.15_suppl.2602.
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2602 Background: ASP3026 (3026) is a selective, potent, ATP-competitive, small molecule oral inhibitor of ALK receptor tyrosine kinase that has not previously been tested in humans. A Phase 1 dose-escalation trial, using a 3+3 design, evaluating 3026 as an oral single agent was conducted to investigate PK (Day 1 and Day 28), safety and clinical activity in patients (pts) with advanced malignancies (excluding leukemias) of ECOG PS 2 or less. Methods: 3026 was administered under fasting conditions on a continuous schedule to pts in successive dose-escalating cohorts at doses ranging from 25 mg QD to 800 mg QD. Results: Thirty pts were enrolled into the dose escalation part of the study. The MTD was determined based on DLT data from cycle 1. Three DLTs were observed: grade 2 nausea and vomiting leading to dose reduction at 525 mg QD; grade 3 rash leading to dose reduction, and grade 3 ALT/AST increase leading to study withdrawal at 800 mg QD. The most common AEs were constipation, vomiting, diarrhea, nausea and abdominal pain, and all AEs were manageable and reversible. Median AUC and Cmax increased proportionally with dose from 25 mg QD to 800 mg QD. There was no evidence of non-linear PK at ASP3026 doses >25 mg QD. The median terminal half-life was approximately 10 - 41 hours. Overall, A3026 appears well absorbed with median Tmax around 3 hours for both Day 1 and Day 28. Terminal T1/2 appears adequate for one daily dosing with median values ranging from approximately 18 to 34 hours. Based on visual inspection of pre-dose (trough) values from Days 8, 15, 22, and 28 it appears that steady-state conditions are achieved by day 28. Conclusions: The MTD of 3026 is 525 mg QD. Treatment with 3026 resulted in a promising safety and PK profile in pts with advanced malignancies. Further evaluation of 3026 in pts with tumors harboring gene mutation or ALK fusion genes in the cohort expansion phase at the MTD is ongoing. Clinical trial information: NCT01401504.
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Motamed, Hassan, Meisam Moezi, and Mohamadreza Dadkhah. "Intravenous Sodium Valproate Versus Dexamethasone Evaluation for Migraine Headache Pain Control in Acute Setting: A Randomized, Controlled, Double-Blind Study." Pakistan Journal of Medical and Health Sciences 15, no. 6 (June 30, 2021): 1800–1806. http://dx.doi.org/10.53350/pjmhs211561800.
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Introduction: Migraine is a common disease in the emergency department (ED), which is capable of imposing limitations on people’s activity and imposing a high cost on the government. There are a lot of common treatments for migraine. In numerous studies, sodium valproate is included, among other treatments. This Study designed for efficacy evaluation of Sodium Valproate versus Dexamethasone in acute migraine headache pain control. Method: A controlled clinical trial has been established for ED patients with compliant of acute migraine headaches. 108 patients were included and categorized into two groups based on a randomized schedule: one with 1200 mg sodium valproate and another with 8 mg dexamethasone in 150 mL normal saline, which was IV infused in 10 minutes. As a primary outcome, pain visual analog scale (VAS) score was determined and compared on arrival and minutes 30, 60 and 120 after intervention, and as a secondary outcome, the percentage of rescue from headache through medication and sustainability of freedom and relief from headache were determined and compared between the two groups. Results: The mean decline of pain VAS score (0–10) in the sodium valproate group was 2.33 SD (1.74) and 3.49 SD (2.56), and in the dexamethasone group, it was 2.20 SD (1.86) and 3.30 SD (2.45) in the first and second hours after intervention, respectively. In each group, they are statistically significant (P < 0.05), even though there was no statistically significant difference between the two groups of study (P > 0.05). In terms of need for rescue medication, in the sodium valproate group, 30/54 (55.6%) people and in the dexamethasone group, 33/54 (61.1%) people used the medication; however, there were no statistically significant differences found between the two groups (P > 0.05). Conclusion: Probably it can be concluded that there is no statistically significant difference between the efficacy of 1200 mg IV sodium valproate compared and 8 mg IV dexamethasone in reducing acute migraine headache Keywords: Sodium valproate, dexamethasone, acute migraine, pain control.
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Pierce, Janelle M., Amy D. Spriggs, David L. Gast, and Deanna Luscre. "Effects of Visual Activity Schedules on Independent Classroom Transitions for Students with Autism." International Journal of Disability, Development and Education 60, no. 3 (September 2013): 253–69. http://dx.doi.org/10.1080/1034912x.2013.812191.
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van Dijk, Wilhelmina, and Nicholas A. Gage. "The effectiveness of visual activity schedules for individuals with intellectual disabilities: A meta-analysis." Journal of Intellectual & Developmental Disability 44, no. 4 (March 7, 2018): 384–95. http://dx.doi.org/10.3109/13668250.2018.1431761.
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Knight, Victoria, Emily Sartini, and Amy D. Spriggs. "Evaluating Visual Activity Schedules as Evidence-Based Practice for Individuals with Autism Spectrum Disorders." Journal of Autism and Developmental Disorders 45, no. 1 (August 1, 2014): 157–78. http://dx.doi.org/10.1007/s10803-014-2201-z.
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Lim, Elgene, Komal L. Jhaveri, Jose Alejandro Perez-Fidalgo, Meritxell Bellet, Valentina Boni, Jose Manuel Perez Garcia, Laura Estevez, et al. "A phase Ib study to evaluate the oral selective estrogen receptor degrader GDC-9545 alone or combined with palbociclib in metastatic ER-positive HER2-negative breast cancer." Journal of Clinical Oncology 38, no. 15_suppl (May 20, 2020): 1023. http://dx.doi.org/10.1200/jco.2020.38.15_suppl.1023.
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1023 Background: GDC-9545 is a potent, orally available, selective estrogen receptor degrader developed for the treatment of ER-positive (ER+) breast cancer alone or combined with CDK4/6 inhibitors. A first-in-human study evaluated 10-250 mg GDC-9545; tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and clinical results support expansion cohorts at ≥30 mg (Jhaveri et al., 2019). Methods: This study evaluated PK, PD, and efficacy of GDC-9545 alone and combined with palbociclib, ± LHRH agonist. Eligible patients (pts) had ER+ (HER2-) metastatic breast cancer (MBC) with ≤ 2 prior therapies in the advanced or metastatic setting. No prior treatment with CDK4/6 inhibitor was allowed in pts receiving palbociclib. Results: Eight-five pts were enrolled in 2 cohorts: GDC-9545 100 mg given once daily ± LHRH agonist (Cohort A), and GDC-9545 100 mg +125 mg palbociclib on a 21 day on/7 day off schedule ± LHRH agonist (Cohort B). Of the 39 pts in Cohort A, adverse events (AE) occurring in ≥10% of pts were fatigue, cough, back pain, pain in extremity, and arthralgia. Related AEs were generally Grade (G) 1-2; there were 3 related G3 AEs of fatigue, transaminase increased, and diarrhea. Two pts had GDC-9545 reduced, one due to G3 diarrhea and another due to G3 transaminitis. Of the 46 pts in Cohort B, AEs in ≥10% of pts were neutropenia, fatigue, bradycardia, diarrhea, constipation, dizziness, nausea, anemia, asthenia, thrombocytopenia, pruritus, and visual impairment. Twenty-six (57%) pts had G≥3 AEs. G≥3 neutropenia was reported in 23 (50%) pts. One pt had palbociclib reduced due to G3 febrile neutropenia. Eleven (13%) of 85 pts had G1 asymptomatic bradycardia considered related to GDC-9545. No pts in either cohort discontinued study treatment due to AEs. PK analysis and clinical data demonstrate no clinically relevant drug-drug interactions between GDC-9545 and palbociclib. Reduced ER, PR, and Ki67 levels, and an ER activity signature, were observed in paired pre- and on-treatment biopsies (n = 12). Eighteen of 33 pts in Cohort A had either confirmed partial responses or were on study 24 weeks (clinical benefit rate 55%). Clinical benefit was observed in pts with prior fulvestrant treatment and with detectable ESR1 mutations at enrollment. Clinical benefit data for both cohorts are anticipated to be mature in April 2020. Conclusions: GDC-9545 was well-tolerated as a single agent and in combination with palbociclib with encouraging PK, PD, and anti-tumor activity in ER+ MBC to support Phase III development. Clinical trial information: NCT03332797 .
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Spriggs, Amy D., Pamela J. Mims, Wilhelmina van Dijk, and Victoria F. Knight. "Examination of the Evidence Base for Using Visual Activity Schedules With Students With Intellectual Disability." Journal of Special Education 51, no. 1 (July 18, 2016): 14–26. http://dx.doi.org/10.1177/0022466916658483.
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We conducted a comprehensive review of the literature to establish the evidence base for using visual activity schedules (VAS) with individuals with intellectual disability. Literature published after 2005 was evaluated for quality using the criteria developed by Horner et al.; a total of 14 studies were included as acceptable. Findings suggest that VAS is an evidence-based practice for teaching a variety of daily living, navigation, vocational, recreation, and academic skills to adolescents and adults with intellectual disability. Results also show increases in independence and on-task behaviors. We conclude the article by discussing limitations and recommendations for future research.
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Zhang, Ying, Tharin Limsakun, Debra M. Bensen-Kennedy, Alex Veldman, and Zhenling Yao. "Population Pharmacokinetic Modeling and Simulation of Recombinant Single-Chain Factor VIII (r VIII-SingleChain) in Patients with Hemophilia a." Blood 124, no. 21 (December 6, 2014): 2814. http://dx.doi.org/10.1182/blood.v124.21.2814.2814.
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Abstract Introduction: Hemophilia A is a rare but serious X-linked recessive bleeding disorder that affects males and is characterized by a deficiency in the plasma protein known as coagulation Factor VIII. rVIII-SingleChain is a proprietary, lyophilized formulation of clotting factor VIII (FVIII) produced by recombinant technology. As part of the clinical development of rVIII-SingleChain, a population pharmacokinetic (PK) analysis was undertaken, utilizing data from Study CSL627_1001 in subjects with hemophilia A, with the objectives of (a) characterizing the PK of rVIII-SingleChain at a population level, (b) assessing the ability of various patient characteristics (e.g., von Willebrand factor, VWF) to describe variability in the PK parameters, and (c) enable population-based simulations of rVIII-SingleChain dosing regimens that may provide improved prophylaxis coverage compared with octocog alfa (Advate®). Methods: Twenty-seven male subjects (aged 19-60 years) enrolled in Study CSL627_1001 (Part 1) received a single 50 IU/kg IV infusion of Advate®, followed by a single 50 IU/kg IV infusion of rVIII-SingleChain, with a minimum 4-day washout period. Plasma PK samples (for the determination of FVIII activity) were collected over 72 hours for both Advate® and rVIII-SingleChain (at pre-specified time points) and were measured by a validated chromogenic assay. Population PK models were developed separately for rVIII-SingleChain and Advate®, using the NONMEM 7 with FOCEI method. Various covariates, including VWF, body weight, and effect of age on clearance (CL) and volume of distribution were tested. Bootstrap and visual predictive check (VPC) were used for model evaluation. Simulations of different dosing regimens were performed to evaluate the FVIII activity plasma exposure profiles that may provide improved prophylaxis coverage. Results: A two-compartmental model with first-order elimination was developed to describe FVIII plasma activity data for both rVIII-SingleChain and Advate®. VWF was found to be a significant covariate influence on FVIII plasma activity CL, whilst body weight influenced both CL and volume of distribution in the central compartment. Population parameter estimates indicated a lower CL (2.02 vs 2.49 dL/h) and longer half-life (13.1 vs 9.3 h) for rVIII-SingleChain compared with Advate®. The results of bootstrap and VPC implied that the model was stable, and the parameters were estimated with good precision. PK simulations indicated that rVIII-SingleChain, at the same doses and frequencies, resulted in higher FVIII plasma activities throughout the dosing period, as reflected in higher area-under-the-curve (AUC). The dosing regimens for the simulations were designed based on the dosing recommendations of the Advate® label and rVIII-SingleChain phase III study. The results showed that rVIII-SingleChain provided a higher percentage of subjects with trough levels of at least 1% FVIII plasma activity, compared with Advate® at the same dosing regimen. Every 3 days dosing at 40-50 IU/kg rVIII-SingleChain was predicted to achieve similar prophylaxis protection compared with Advate® every 2 days (i.e., about 90% of subjects with trough levels of at least 1% FVIII plasma activity). In addition, 73-90% of subjects were predicted to achieve trough levels of at least 1% FVIII plasma activity with twice weekly dosing (4- and 3-day schedule) at 50 IU/kg rVIII-SingleChain, compared with 65-80% of subjects dosed with Advate® using the same regimen. Conclusion: The population model shows that rVIII-SingleChain has a longer half-life, lower CL and higher AUC compared with Advate®. Simulations demonstrated that rVIII-SingleChain resulted in higher trough concentrations when compared with Advate®, indicating the possibility of greater prophylaxis coverage. Disclosures Zhang: CSL Behring: Employment. Limsakun:CSL Behring: Employment. Bensen-Kennedy:CSL Behring: Employment. Veldman:CSL Behring GmbH: Employment. Yao:CSL Behring: Employment.
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Bertrand, D., N. Pype, T. Conings, D. De Cock, S. Pazmino, M. Doumen, J. Joly, B. Neerinckx, R. Westhovens, and P. Verschueren. "POS0616 LONG-TERM EFFECTIVENESS AFTER MULTIPLE CYCLES WITH RITUXIMAB FOLLOWING AN ON-FLARE RETREATMENT STRATEGY IN PATIENTS WITH RHEUMATOID ARTHRITIS." Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 545–46. http://dx.doi.org/10.1136/annrheumdis-2021-eular.1783.
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Background:Rituximab is known as an efficacious drug for the treatment of Rheumatoid Arthritis (RA). The recommended administration schedule consist of 2 infusions of 1000 mg with a 2-week interval. In Belgium an on-flare retreatment strategy is followed, making evaluation of effectiveness over time challenging. Moreover the patient’s view on this strategy is unclear.Objectives:To explore long-term effectiveness and safety of rituximab in daily clinical practice in patients with RA.Methods:Data of patients diagnosed with RA and treated with rituximab in a tertiary university hospital were retrospectively collected. For every cycle, clinical data were recorded at the time of the first and second infusion, the 16-week visit and the visit on which the treating rheumatologist decided to prescribe a new cycle. Data on demographics, previous RA treatment, disease activity, patient-reported outcomes, adverse events related to rituximab, dose and number of cycles were collected from 01/01/2006 until 01/12/2019 or until discontinuation of rituximab. The visit on which rituximab was prescribed for the first time was considered as the baseline visit. The data were analysed descriptively.Results:Data of 66 patients with RA were collected. The median (IQR) age was 57.0 (47.0-65.0) years at baseline and 56% (37/66) were female. Most patients were seropositive (RF 91% and ACPA 92%), and had erosive (71%) or nodular disease (53%). The median (IQR) disease duration was 12.5 (4.0-18.3) years. In total, 94% of the patients had failed at least one other biological Disease-modifying Antirheumatic Drug (bDMARD) before starting rituximab. Overall, patients received a median (IQR) of 3 (2-7) cycles of rituximab. Seven of the 66 patients (11%) discontinued rituximab and changed to another bDMARD after a median (IQR) of 1 (1-6) cycles and 11% were treated with a lower dose than 2x1000mg. The median (IQR) interval between the first 2 cycles was 7.0 (6.0-10.0) months, after which this increased to up to one year (interval between cycle 2-3: 10.0 (7.0-13.0) months, cycle 3-4: 12.0 (7.3-15.5) months). The overall median (IQR) follow-up time was 45.5 (14.8-82.3) months. The efficacy of rituximab remained after repeated cycles: after every treatment with rituximab, a reduction in disease activity based on the disease activity score in 28 joints (DAS28) could be noticed (figure 1A). The evolution in patients’ (PaGH) and physicians’ global health (PhGH) assessment followed the same pattern as the DAS28-score (Figure 1B). High PaGH-scores could be noticed at every start of a new rituximab cycle. The proportion of patients with a PaGH-score above 20 ranged from 84% - 100%, 74% - 100% and 66% - 86% at the first infusion, second infusion and week 16 visits, respectively. Rituximab was considered to be well-tolerated. In total, 23 adverse events in 12 patients were recorded and none of them were serious.Conclusion:Rituximab can be considered a highly efficacious drug for RA treatment in daily practice. There were no major side effects and there was an increasing treatment interval over time. However, a healthy survivor effect should be kept in mind when interpreting the results. It should be noted that with the on-flare retreatment strategy, every new rituximab cycle was preceded by a rise in PaGH-scores, which reflects a state of impaired wellbeing reported by patients. This should be further studied with qualitative methods and in a randomized trial setting comparing on-flare with fixed-interval retreatment to evaluate optimal effectiveness.Figure 1.Evolution in median - interquartile range disease activity (DAS28CRP) (A) and patients’ (PaGH) and physicians’ global health (PhGH) (B) over the different rituximab cycles. The disease activity, PaGH and PhGH were measured at baseline, the time of the first and second infusion, W16 and the visit on which a new rituximab cycle was prescribed. The dotted lines represent a DAS28CRP-score of 2.6 (remission cut-off) and 3.2 (low disease activity cut-off). C: cycle; W: week; VAS: visual analogue scale.Disclosure of Interests:None declared
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Knurowski, Tomasz, Karen Clegg, Nigel Brooks, Fay Ashby, Neil A. Pegg, William West, Harriet S. Walter, Tim CP Somervaille, Steven Knapper, and Andrew Davies. "An Open-Label Phase I/IIa Study to Evaluate the Safety and Efficacy of CCS1477, a First in Clinic Inhibitor of the p300/CPB Bromodomains, As Monotherapy in Patients with Advanced Haematological Malignancies." Blood 134, Supplement_1 (November 13, 2019): 1266. http://dx.doi.org/10.1182/blood-2019-124797.
Full textAbstract:
Background CCS1477 is a first in class potent, selective and orally bioavailable inhibitor of the bromodomains of p300 and CBP, two closely related histone acetyl transferases with oncogenic roles in haematological malignancies. In pre-clinical studies, CCS1477 was found to be a potent inhibitor of cell proliferation in acute myeloid leukaemia (AML) multiple myeloma (MM) and non-Hodgkin lymphoma (NHL) cell lines. In primary patient AML blast cells CCS1477 inhibited proliferation through a combination of cell cycle arrest at the G1/S transition and an induction of differentiation (up-regulation of CD11b and CD86). CCS1477 has significant anti-tumour activity, inducing tumour regressions in xenograft models of AML and MM. These effects were accompanied by significant reductions in tumour MYC and IRF4 expression. Additionally, there are molecular features of certain haematological malignancies that are likely to increase the sensitivity to p300/CBP inhibition with CCS1477. For example, in B-cell lymphomas there are frequent loss of function mutations in CBP that are associated with heightened sensitivity to pre-clinical inhibition of corresponding non-mutated p300. CCS1477 represents a novel and differentiated approach to inhibiting cell proliferation and survival and offers a potential new therapeutic option for patients who have relapsed or are refractory to current standard of care therapies in AML, MM or NHL. Study Design and Methods This study is the first time that CCS1477 is being dosed in patients with haematological malignancies. The Phase I/IIa study aims to determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) and schedule(s) of CCS1477 and investigate clinical activity of CCS1477 monotherapy in patients with haematological malignancies. This study will also characterise the pharmacokinetics (PK) of CCS1477 and explore potential biological activity by assessing pharmacodynamic and exploratory biomarkers. The trial aims to enrol approximately 90 patients and is currently recruiting in the UK with plans to open additional sites in the USA. Key inclusion criteria include patients with confirmed (per standard disease specific diagnostic criteria), relapsed or refractory haematological malignancies (AML, MM and NHL). Patients must have received standard therapy which for the majority of therapeutic indications is at least 2 prior lines of therapy. Single dose and steady state pharmacokinetics will be determined in all patients. AML response will be measured in bone marrow samples. Myeloma response will be evaluated according to the 'International Myeloma Working Group Response Criteria' based on changes in M protein in blood and/or urine, changes in serum free light chains if measurable, and changes on imaging and/or bone marrow if applicable and according to the guidelines. In NHL patients, tumour assessments will be done for measurable disease, non-measurable disease, and new lesions on CT (or magnetic resonance imaging [MRI]) and/or combined with visual assessment of [18F]2-fluoro-2-deoxy-D-glucose-positron emission tomography (FDG-PET) for response assessment per recent International Working Group consensus criteria (RECIL 2017), until progression The study will begin with two parallel monotherapy dose-escalation arms; Arm 1: Relapsed or refractory NHL and MM; Arm2: Relapsed or refractory AML/high-risk MDS. Once a recommended phase 2 dose/schedule is reached, three monotherapy expansion arms will be opened in AML/high-risk MDS (15 patients), MM (15 patients) and NHL (30 patients). Blood samples along with bone marrow biopsies and aspirates will be collected for exploratory biomarker analysis to understand mechanisms of response to treatment or disease progression. This will include the analysis of tumour-specific and circulating biomarkers, such as tumour DNA, mRNA, proteins or metabolites. In NHL patients, analysis of CBP (and p300) mutations will be undertaken to allow retrospective correlation with tumour response and to determine if loss of function mutations in the genes for either proteins can be utilised as response predictive biomarkers in future studies. Disclosures Clegg: CellCentric Ltd: Employment, Equity Ownership. Brooks:CellCentric Ltd: Employment, Equity Ownership. Ashby:CellCentric Ltd: Employment, Equity Ownership. Pegg:CellCentric Ltd: Employment, Equity Ownership. West:CellCentric Ltd: Employment, Equity Ownership. Somervaille:Novartis: Consultancy. Knapper:Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Daiichi Sankyo: Honoraria; Jazz: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Tolero: Membership on an entity's Board of Directors or advisory committees; Pfizer: Membership on an entity's Board of Directors or advisory committees. Davies:ADCT Therapeutics: Honoraria, Research Funding; MorphoSys AG: Honoraria, Membership on an entity's Board of Directors or advisory committees; BioInvent: Research Funding; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Kite Pharma: Membership on an entity's Board of Directors or advisory committees; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Bayer: Research Funding; Karyopharma: Membership on an entity's Board of Directors or advisory committees, Research Funding; Acerta Pharma: Honoraria, Research Funding; GSK: Research Funding; Pfizer: Honoraria, Research Funding; Roche: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen: Honoraria, Research Funding; Gilead: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding.
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Roca, Meritxell, Daniel Aranda, and Jordi Sánchez-Navarro. "Television and the Internet: The Role Digital Technologies Play in Adolescents’ Audio-Visual Media Consumption. Young Television Audiences in Catalonia (Spain)." Journal of Youth Development 9, no. 1 (March 1, 2014): 71–85. http://dx.doi.org/10.5195/jyd.2014.73.
Full textAbstract:
The aim of this reported study was to investigate adolescents TV consumption habits and perceptions. Although there appears to be no general consensus on how the Internet affects TV consumption by teenagers, and data vary depending on the country, according to our study, Spanish adolescents perceive television as a habit “of the past” and find the computer a device more suited to their recreational and audio-visual consumption needs. The data obtained from eight focus groups of teenagers aged between 12 and 18 and an online survey sent to their parents show that watching TV is an activity usually linked to the home’s communal spaces. On the contrary, online audio-visual consumption (understood as a wider term not limited to just TV shows) is perceived by adolescents as a more convenient activity as it adapts to their own schedules and needs.
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Arruabarrena, Carolina, Mario Damiano Toro, Mehmet Onen, Boris E. Malyugin, Robert Rejdak, Danielle Tognetto, Sandrine Zweifel, Rosa Giglio, and Miguel A. Teus. "Impact on Visual Acuity in Neovascular Age Related Macular Degeneration (nAMD) in Europe Due to COVID-19 Pandemic Lockdown." Journal of Clinical Medicine 10, no. 15 (July 25, 2021): 3281. http://dx.doi.org/10.3390/jcm10153281.
Full textAbstract:
This is a retrospective, multicenter study of consecutive patients with nAMD scheduled for a visit and/or a treatment with an intravitreal injection (IVI) during the 3 months before lockdown in the Ophthalmology Departments of six centers of Europe.The study was conducted on 546 patients, of which 55.13% were females, almost 100% of the patients were White/Caucasian race, and 71.53% of the patients presented a type 1 macular neovascularization (NVM). A total of 62.82% of patients (343 patients) that were on scheduled clinic visits and/or intravitreal injection treatment during the 3 months before the quarantine did not attend either to visit or for treatment during the lockdown. The mean number of injections during the lockdown was significantly reduced. This was followed by a significant reduction in the mean best-corrected visual acuity (BCVA) between the 3 months before the lockdown (mean BCVA of 60.68 ± 19.77 letters) and 6 months after lockdown (mean BCVA of 56.98 ± 22.59 letters). Patients with better BCVA before the lockdown and the ones showing neovascular activity were more likely to attend their scheduled visits and/or IVI treatments. The COVID-19 pandemic and the lockdown have led to a decrease in the number of IVI treatments in patients with nAMD, evidencing a significant vision loss at 6 months.