Total Number Of Trials Research Articles

Exposure to humans and task difficulty levels affect wild raccoons (Procyon lotor) learning.

Cognition helps wildlife exploit novel resources and environments. Raccoons (Procyon lotor) have successfully adapted to human presence, in part due to their cognitive abilities. However, interactions between humans and wildlife can create conflict. A better understanding of the raccoon's behavioral flexibility and learning ability could mitigate some conflicts. Our objective was to evaluate wild raccoons learning in contexts varying in terms of exposure to humans (recreational and preservation zoning within protected areas) and task difficulty. Learning can be evaluated over multiple exposures to a cognitive task. Across three years of experiment, we employed 2 food extraction tasks to gauge the change in problem-solving performance over trials. This assessment considered the success probability (the number of successful trials divided by the total number of trials) and the time taken to solve the puzzles. We also looked at the effects of 2 behavioral traits, exploratory diversity and persistence. We found strong evidence for learning over consecutive trials in terms of improved success probability. Improvement in terms of success probability and solving time was more pronounced with the initially easier task. We detected an increase in success probability over trials only in the recreation zones, and there was no evidence of an effect of behavioral traits. The improved performance attributed to learning was also maintained over consecutive years. We provide additional evidence that raccoons can learn how to solve a problem, resulting in a more effective solution in consecutive trials. Finally, we consider the management implications of dealing with raccoons accessing anthropogenic resources.

Pyrethroid and Chlorpyrifos Pesticide Exposure, General Intellectual Abilities, and Executive Functions of School Children from Montevideo, Uruguay.

Children's developing brains are susceptible to pesticides. Less is known about the effect of exposure to chlorpyrifos and pyrethroids on executive functions (EF). We measured urinary 3,5,6-trichloro-2-pyridinol (TCPy), a metabolite of chlorpyrifos, and urinary 3-phenoxybenzoic acid (3-PBA), a general, nonspecific metabolite of pyrethroids in first-grade children from Montevideo, Uruguay (n = 241, age 80.6 ± 6.4 months, 58.1% boys). EFs were assessed with the Intra-dimensional/Extra-dimensional shift (IED), Spatial Span (SSP), and Stockings of Cambridge (SOC) tests from the Cambridge Neuropsychological Test Automated (CANTAB) Battery. General intellectual ability (GIA) was assessed using the Woodcock-Muñoz Cognitive battery. Median (range) urinary TCPy and 3-PBA levels were 16.7 (1.9, 356.9) ng/mg of creatinine and 3.3 (0.3, 110.6) ng/mg of creatinine, respectively. In multivariable generalized linear models, urinary TCPy was inversely associated with postdimensional errors on the IED task β [95% CI]: -0.11 [-0.17, -0.06]. Urinary 3-PBA was inversely associated with the total number of trials -0.07 [-0.10, -0.04], and the total number of errors -0.12 [-0.18, -0.07] on the IED task. When TCPy and 3-PBA were modeled together, the associations did not differ from single-metabolite models. We found no evidence of effect modification by blood lead level (BLL). Pesticide exposure may affect EF performance in urban children.

Access to unpublished protocols and statistical analysis plans of randomised trials

BackgroundAccess to protocols and statistical analysis plans (SAPs) increases the transparency of randomised trial by allowing readers to identify and interpret unplanned changes to study methods, however they are often not made publicly available. We sought to determine how often study investigators would share unavailable documents upon request.MethodsWe used trials from two previously identified cohorts (cohort 1: 101 trials published in high impact factor journals between January and April of 2018; cohort 2: 100 trials published in June 2018 in journals indexed in PubMed) to determine whether study investigators would share unavailable protocols/SAPs upon request. We emailed corresponding authors of trials with no publicly available protocol or SAP up to four times.ResultsOverall, 96 of 201 trials (48%) across the two cohorts had no publicly available protocol or SAP (11/101 high-impact cohort, 85/100 PubMed cohort). In total, 8/96 authors (8%) shared some trial documentation (protocol only [n = 5]; protocol and SAP [n = 1]; excerpt from protocol [n = 1]; research ethics application form [n = 1]). We received protocols for 6/96 trials (6%), and a SAP for 1/96 trial (1%). Seventy-three authors (76%) did not respond, 7 authors responded (7%) but declined to share a protocol or SAP, and eight email addresses were invalid (8%). A total of 329 emails were sent (an average of 41 emails for every trial which sent documentation). After emailing authors, the total number of trials with an available protocol increased by only 3%, from 52% in to 55%.ConclusionsMost study investigators did not share their unpublished protocols or SAPs upon direct request. Alternative strategies are needed to increase transparency of randomised trials and ensure access to protocols and SAPs.

Quantifying geographical accessibility to cancer clinical trials in different income landscapes

BackgroundClinical trials are increasingly perceived as a therapeutic opportunity for cancer patients. Favoring their concentration in few high-expertise academic centers maximizes quality of data collection but poses an issue of access equality. Analytical tools to quantify trial accessibility are needed to rationalize resources.Materials and methodsWe constructed a distance-based accessibility index (dAI) using publicly available data on demographics, cancer incidence and trials. Multiple strategies were applied to mitigate or quantify clear sources of bias: reporting biases by text mining multiple registries; reliability of simple geographical distance by comparison with high-quality travel cost data for Italy; index inflation due to highly heterogeneous cancer incidence by log-transformation. We studied inequalities by Gini index and time trend significance by Mann–Kendall test. We simulated different resource allocation models in representative countries and identified locations where new studies would maximally improve the national index.ResultsThe dAI approximated well a more realistic but not widely applicable travel cost-based index. Accessibility was unevenly distributed across and within countries (Gini index ∼0.75), with maximal inequalities in high- and upper-middle-income countries (China, United States, Russian Federation). Over time, accessibility increased but less than the total number of trials, most evidently in upper-middle-income countries. Simulations in representative countries (Italy and Serbia) identified ideal locations able to maximally raise the national index.ConclusionsAccess to clinical trials is highly uneven across and within countries and is not mitigated by simple increase in the number of trials; a rational algorithmic approach can be used to mitigate inequalities.

Optimal Learning Under Time Constraints: Empirical and Simulated Trade-offs Between Depth and Breadth of Study.

Learners are often constrained by their available study time, typically having to make a trade-off between depth and breadth of learning. Classic experimental paradigms in memory research treat all items as equally important, but this is unlikely the case in reality. Rather, information varies in importance, and people vary in their ability to distinguish what is more or less important. We test the impact of this trade-off in the study of Graduate Record Examination (GRE)-synonym word pairs. In our empirical Study 1, we split our stimuli set, with some items (focal) being afforded more rounds of retrieval practice than other items (non-focal). All conditions had the same total number of trials (i.e., constant study time), but differed in the number of focal words (breadth) and repetitions (depth). The conditions differed significantly in both mean performance and variance on the day-delayed test. Using this empirical data as a base, we then conducted a simulation (Study 2) modeling depth-breadth trade-offs under various conditions of learner forecasting accuracy and test coverage. In Study 2, we found that a medium-depth medium-breadth strategy was appropriate for most of the learning situations covered by our simulation, but that learners with a well-calibrated understanding of importance may benefit from a more targeted high-depth, low-breadth approach. Our results highlight the complexity of navigating the depth-breadth trade-off. Models of learning strategy optimization will need to account for learner forecasting sensitivity, which itself is likely an interaction between relatively stable individual differences and shifting contextual factors.

Estimation of missing total number of trials in binomial time series analysis by a BDLM process with an illustration of the COVID-19 pandemic data

The criteria used for sample size determination are generally developed based on applying averaging techniques to the possible values a variable can take on. This paper presented new methods for estimation of sample size, in particular for binomial distribution, when an observation on number of successes is available. In this paper, first, the general criteria for the determination of sample size were reviewed. Next, the BDLM process was concisely introduced and fit to the first real-world dataset. Then, based on the model, four new methods for the estimation of the missing total number of trials in binomial time series were developed with the illustrated small dataset, where number of successes at any specific time point was known. In addition, the worst outcome criterion was evaluated based on the highest probability density (HPD) confidence set by using the illustrated data and the results were compared with those of the new methods developed in the present paper. Later, an illustration of COVID-19 trinomial data was presented in which BDLM was fit to the time series of cured cases infected due to COVID-19 disease. Finally, the new methods of estimation of missing total confirmed cases evaluated by the relatively large dataset.

UJI MEKANIKA PAPAN PARTIKEL BERBAHAN DASAR KULIT SERABUT NIPAH (Nyfa fruticans Wurmb) DENGAN PEREKAT RESIN POLYESTER

. In an effort to maximize the increase in economic value nipah plants, it is used to produce sugar, there also needs to be innovations that make nipah plants into high-value products, including the utilization of palm fiber for raw material for making particle boards. The objectives to be achieved in this research are Analyzing the mechanical properties of particle boards from palm oil with polyester resin adhesive. Particle board raw material used for palm fiber, The adhesive used is polyester resin by comparison A = 1:7, B = 1:8, C = 1:9. Static analysis of the data used is a completely randomized design (CRD) with three levels of treatment and three replications so the total number of trials is nine. The resulting density value includes medium density. Value of the resulting density in the treatment A (1:7), B (1:8), C (1:9) successively produce 0,78 gr/cm³, 0,69 gr/cm³, 0,62 gr/cm³. The average value of Modulus of Elasticity (MoE) The resulting effect is not real and does not meet SNI 03-2105-2006 min 20.400 kg/cm² except in the treatment A2, A3, B1, B3 that meets the standards SNI, Modulus of Rupture (MoR) The result has no real effect and the value produced meets SNI 03-2105-2006 for all treatments that require a minimum 82 kg/cm² in all treatments.Keywords: Particle Board; SNI 03-2105-2006; Polyester Resin; MoE; MoR

Tandem gait test performance in healthy, physically active adults: Clinical implications for concussion evaluation

ObjectivesTo identify factors affecting performance on the tandem gait test in healthy, physically active adults. DesignCross-sectional. MethodsParticipants completed the tandem gait test according to Sport Concussion Assessment Tool 3 (SCAT3) guidelines. Dependent variables included time for best trial (initial 3m, turn, final 3m and total) and whether the trial was “pass” or “fail”. Independent variables included sex, concussion history, foot length, height and total number of trials. Results55% (35/64) of participants passed the first trial of the tandem gait test; 19% (12/64) had a best time <14s. Sex and concussion history did not affect performance (p>0.05). There were no differences in turn times for those with and without a history of concussion (t=0.26, p=0.80). The number of trials was not significantly correlated with best time (þ=−0.04, p=0.74). There were low (þ=−0.31) to negligible (þ<0.30) correlations between foot length, height and all portions of the test. There was more variability in times for the turn (COV=27%) than during the straight portions (COV=18%). ConclusionsCurrent recommendations for the tandem gait test led to a high false-positive rate in healthy, physically active adults. Sex, concussion history, number of trials and foot length had little to no influence on scores on the test. Turning times were more variable than times on the straight portions of the test. Clinicians may use these results as a guideline when interpreting performance on the tandem gait test in healthy physically active adults.

Prefrontal Cortex and Amygdala Subregion Morphology Are Associated With Obesity and Dietary Self-control in Children and Adolescents.

A prefrontal control system that is less mature than the limbic reward system in adolescence is thought to impede self-regulatory abilities, which could contribute to poor dietary choices and obesity. We, therefore, aimed to examine whether structural morphology of the prefrontal cortex (PFC; involved in cognitive control) and the amygdala (a key brain region for reward-related processing) are associated with dietary decisions and obesity in children and adolescents. Seventy-one individuals between the ages of 8–22 years (17.35 ± 4.76 years, 51% female, 56% were overweight or obese) participated in this study; each participant completed a computer-based food choice task and a T1- and T2-weighted structural brain scans. Two indices of obesity were assessed, including age- and sex-specific body mass index (BMIz) and waist-to-height ratio (WHtR). The behavioral task included rating 60 food stimuli for tastiness, healthiness, and liking. Based on each participant’s self-ratings, 100 binary food choices were then made utilizing a computer mouse. Dietary “self-control” was calculated as the proportion of trials where the individual chose the healthier food item (vs. the tastier food item) over the total number of trials. Cortical thickness and amygdala subnuclei volumes were quantified using FreeSurfer 6.0 and CIT168 atlas, respectively. We found that WHtR was negatively associated with the thickness of bilateral superior frontal, left superior temporal, right insula, and right inferior temporal regions (p < 0.05, corrected for multiple comparisons). We also found WHtR to be positively associated with the volume of the central nucleus (CEN) region of the amygdala (p = 0.006), after adjusting for the hemisphere, age, sex, and intracranial volumes. A similar data pattern was observed when BMIz was used. Moreover, we found that across all participants, thinner right superior frontal cortex and larger left CEN volumes predicted lower dietary self-control. These results suggest that differential development of the PFC and amygdala relate to obesity and dietary self-control. Further longitudinal studies are merited to determine causal relationships among altered PFC to amygdala neural circuitry, dietary self-control, and obesity.

Evaluation of Ground Reaction Forces and Limb Symmetry Indices Using Ground Reaction Forces Collected with One or Two Plates in Dogs Exhibiting a Stifle Lameness.

The aim of the study was to evaluate the efficiency and consistency in the collection of ground reaction forces using one or two force plates from dogs with stifle lameness. Twenty-two client-owned dogs with unilateral stifle lameness were used. In a prospective study design, data were collected at a single time point using both one- and two-plate collection methods. Ground reaction forces collected included peak vertical force, vertical impulse and associated symmetry indices. Additionally, time required to obtain valid trials and the total number of trials were also recorded for both one-plate and two-plate collections. Linear mixed models were used to analyse differences in peak vertical force, vertical impulse and symmetry indices between the collection methods. A paired-T test was used to compare trial number and time of trial collection. The significance threshold was p < 0.05. It took significantly longer to collect valid trials using one-plate both in time (16.1 ± 8.0 minutes vs, 8.0 ± 4.3 minutes with two plates) and number of trials (33.8 ± 14.8 trials vs. 16.4 ± 8.8 trials with two plates) (p < 0.0001). There was no difference in peak vertical force or vertical impulse data between collection methods. Neither the peak vertical force symmetry indices nor the vertical impulse symmetry indices were significantly different between one- and two-plate collection techniques. The total time and number of trials needed to collect valid trials in dogs with stifle lameness were minimized through the use of two force plates. However, there was no significant difference in the ground reaction force or symmetry index values collected between the two systems.

Exclusion of Pregnant Women from Clinical Trials during the Coronavirus Disease 2019 Pandemic: A Review of International Registries.

Objective Pregnant women have been historically excluded from clinical trials for nonobstetric conditions, even during prior epidemics. The objective of this review is to describe the current state of research for pregnant women during the coronavirus disease 2019 (COVID-19) pandemic. Study Design We conducted a search of international trial registries for trials relating to the novel coronavirus. The eligibility criteria for each trial were reviewed for inclusion/exclusion of pregnant women. Relevant data were extracted and descriptive statistics were calculated for individual and combined data. The total number of trials from each registry were compared, as well as the proportions of pregnancy-related trials within each. Results Among 621,370 trials in the World Health Organization International Clinical Trials Registry, 927 (0.15%) were COVID-19 related. Of those, the majority (52%) explicitly excluded pregnancy or failed to address pregnancy at all (46%) and only 16 (1.7%) were pregnancy specific. When categorized by region, 688 (74.2%) of COVID-19 trials were in Asia, followed by 128 (13.8%) in Europe, and 66 (7.2%) in North America. Of the COVID-19 trials which included pregnant women, only three were randomized-controlled drug trials. Conclusion Approximately 1.7% of current COVID-19 research is pregnancy related and the majority of trials either explicitly exclude or fail to address pregnancy. Only three interventional trials worldwide involved pregnant women. The knowledge gap concerning the safety and efficacy of interventions for COVID-19 created by the exclusion of pregnant women may ultimately harm them. While “ethical” concerns about fetal exposure are often cited, it is in fact unethical to habitually exclude pregnant women from research. Key Points Pregnancy was excluded from past pandemic research.Pregnancy is being excluded from COVID-19 research.Exclusion of pregnant women is potentially harmful.

Cancer drugs for solid tumors approved by the EMA since 2014: an overview of pivotal clinical trials.

The European Medicine Agency (EMA) authorizes the marketing of drugs, with the authorization being full, conditional or issued under exceptional circumstances. Usually the efficacy and safety of drugs must be demonstrated in at least 2 well-controlled trials, but this rule is not always observed. The objective of the trial is to provide an overview of the pivotal trials of cancer drugs authorized for marketing in Europe since 2014. From the technical data sheets of each drug authorized by the EMA between January 1, 2014 and May 31, 2019, we evaluated the relative pivotal trial(s) in terms of the following characteristics: number of patients, masking, trial phase, number of arms, primary endpoint(s), presence of subgroup analysis, quality of life as endpoint, and value of statistical p. The results provided us with the total number of trials, which we then divided into trials for orphan and non-orphan drugs. We considered 38 medicines, 6 of which were classified as orphans, for a total of 96 pivotal trials. Four drugs had conditional authorization, 1 was authorized under exceptional circumstances. Seventeen drugs underwent only 1 pivotal trial to support marketing authorization. Most of the trials were phase 3 and open-label, with 2 arms. Most trials considered the progression-free survival (PFS) as the primary endpoint, less than 30% of trials consider OS as a primary endpoint, and less than 40% of trials reported quality of life. The p values, with very few exceptions, were below 0.05. The rule of 2 well-controlled trials was complied with in just over 50% of the authorized drugs, and even when there was only 1 pivotal trial supporting the authorization, the trial itself may not have been necessarily well-controlled; the authorization was revoked for a drug because the trial did not confirm the benefits expected from confirmatory trials; while for 2 drugs, the evidence of efficacy yielded by the trials was not considered exhaustive. Considering that sometimes clinical authorization trials do not provide complete data on safety and efficacy, it would be perhaps appropriate to gather more pre-marketing evidence or leverage post-marketing data to complete the available information and have greater certainty.

YÜKSEK ATLAMA VE SIRIKLA ATLAMADA YARIŞMA STRATEJİSİ: KAÇ DENEME?

The pole vault and high jump are events named vertical jumps within track and fields. The aim of the vertical jump events is that the athlete runs on the approach way with proper speed, then jumps upwards and passes over the bar where height is previously determined by the athlete, without dropping the bar to the ground. In the vertical jump events, the competition variables which the starting height, the final height, the difference between the starting and final height, the total number of attempting, the amount of valid and invalid jumps were examined measured within the scope of competition tactics. The aim of this study is to show coaches and athletes how to plan the competition variables in order to achieve the aimed performance by putting forth their competition strategy features. In addition, the study is going to determine the similarities and differences between podium athletes and other finalist athletes through the example of European championship finals where elite athletes compete. The research group consisted of 223 high jumpers (male: 105, female: 118) and 216 pole vaulters (male: 109, female: 107) competing in the European Championships (6 indoor and 5 outdoor) between 2009 and 2019. Statistical comparison of the podium athletes and remaining finalist athletes’ groups was carried out using Independent Samples t-Test. Pearson correlation coefficients (r) were used to express the relationships between parameters. Linear regression analysis was used to find coefficients of determination (r 2 ) for the relationships. Significant differences were found in podium athletes in terms of initial height, final height, difference between them, total number of trials and number of successful trials in both events and both genders. Male and female athletes who have won medals in both high jump and pole vaults have performed a total of 4-8 trials. The difference between the initial height and the final height was 12 ± 4 cm in male high jump podium athletes and 14 ± 3 cm in female high jump athletes; It was found that the male pole vaulters were 34 ± 12 cm and the mean 29 ± 8 cm in females. It is clear that the average of the total number of trials in both events and genders has declined significantly in the last 10 years. The total number of trials was found to be higher in high performing athletes. As a result, it was seen that the medallist athletes had higher initial heights than the other finalists, they reached the final heights with more differences after the initial heights, and the total number of trials and successful trials were higher. In the light of these data, it is recommended that the performance components that are examined and found to be important in this study for vertical jumps be examined in detail by the coaches, and that a strategy for competition management is developed according to the current situation of the athletes.

Lesions to the lateral mammillary nuclei disrupt spatial learning in rats.

The head direction (HD) signal is thought to originate in the reciprocal connections between the dorsal tegmental nuclei (DTN) and the lateral mammillary nuclei (LMN) and lesions to these structures disrupt the HD signal in downstream structures. Lesions to the DTN also disrupt performance on spatial tasks where directional heading is thought to be important. In Experiment 1, rats with bilateral electrolytic lesions of the LMN and sham controls were trained on 2 tasks previously shown to be sensitive to DTN damage. Rats were first trained on either a direction or rotation problem in a water T maze. LMN-lesioned rats were impaired relative to sham controls, on both the first block of 8 trials and on the total number of trials taken to reach criterion. In the food-foraging task, rats were trained to leave a home cage at the periphery of a circular table, find food in a food cup at the center of the table, and return to the home cage. Again, LMN-lesioned rats were impaired relative to sham rats, making more errors on the return component of the foraging trip. In Experiment 2, rats with electrolytic LMN lesions were also impaired on a dry land version of the direction and rotation problems and had difficulty discriminating between reinforced and nonreinforced locations on a 12-arm maze. These results build on previous behavioral and cell-recording studies and demonstrate the importance of the direction system to spatial learning. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Calculation of \u03c0 and Classification of Self-avoiding Lattices via DNA Configuration

Numerical simulation (e.g. Monte Carlo simulation) is an efficient computational algorithm establishing an integral part in science to understand complex physical and biological phenomena related with stochastic problems. Aside from the typical numerical simulation applications, studies calculating numerical constants in mathematics, and estimation of growth behavior via a non-conventional self-assembly in connection with DNA nanotechnology, open a novel perspective to DNA related to computational physics. Here, a method to calculate the numerical value of π, and way to evaluate possible paths of self-avoiding walk with the aid of Monte Carlo simulation, are addressed. Additionally, experimentally obtained variation of the π as functions of DNA concentration and the total number of trials, and the behaviour of self-avoiding random DNA lattice growth evaluated through number of growth steps, are discussed. From observing experimental calculations of π (πexp) obtained by double crossover DNA lattices and DNA rings, fluctuation of πexp tends to decrease as either DNA concentration or the number of trials increases. Based upon experimental data of self-avoiding random lattices grown by the three-point star DNA motifs, various lattice configurations are examined and analyzed. This new kind of study inculcates a novel perspective for DNA nanostructures related to computational physics and provides clues to solve analytically intractable problems.

Abstract A100: Seamless phase I/II clinical trials in oncology: retrospective analysis of the last 7 years

Abstract Introduction: Drug development has evolved from the conventional sequence of three-phase clinical trial process to a seamless approach of adding cohorts to first-in-human trials to investigate both safety and efficacy in various cancers. In this retrospective study, we evaluated the prevalence of large early-phase studies in adult cancer patients; described the clinical characteristics, design, and statistical plan of these studies; and identified which investigational drugs using this seamless strategy were included in the accelerated approval program by the Food and Drug Administration (FDA). Methods: All abstracts presented at the American Society of Clinical Oncology (ASCO) annual meetings from 2010 to 2017 were reviewed. Clinical studies conducted in the pediatric population as well as abstracts reporting trials in progress were excluded. Seamless clinical trials were defined as any phase I/II studies with a sample size of 100 or more patients. The Center for Drug Evaluation and Research (CDER) drug approvals report was used to access the list of drugs included in the accelerated approval program by FDA. Results: We identified a total of 1786 early-phase trials enrolling more than 57,500 patients with malignant neoplasms. More frequently these studies included patients with advanced solid tumors (87%) and targeted therapy and immunotherapy agents were investigated in 64% and 15% of the cases, respectively. Of the 1786 trials, 51 were identified as seamless phase I/II with a sample size of 100 or more patients, representing only 3% of the total number of trials (n=1786) but 15% of the total number of patients (n=57,559). These seamless trials had a median number of 3 (1-13) expansion cohorts and a higher fraction (65%) were presented in the last 3 years (2014-2017), compared with 35% of the studies with results presented between 2010-2013. Fifty active investigational new drugs (67% targeted therapy, 18% immunotherapy, 10% antibody-drug conjugate, 2.0% chemotherapy, 3.9% other) were studied as single agents (53%) or in combination with other therapies (47%). Of the 51 identified large seamless phase I/II trials, only 29 (57%) studies had published results. Further, of these 29 studies, a planned statistical analysis for the calculation of the expansion cohorts’ sample-size was not available in 69% of the cases. The overall rate of significant (grade 3-4) adverse events was 49% (range, 0-100%), and at least one toxic death was reported in 5 of these studies. The pooled response rate (CR+PR) per study was 20% (range, 0.9-77). Considering the group of drugs studied in the 51-seamless phase I/II trials identified here, the FDA granted accelerated approval to 8 drugs and 1 other agent was given priority review. Conclusions: Approximately two-thirds of the studies identified were presented after the year 2014, suggesting an increased use of the seamless approach. While the high rate of accelerated approvals granted by the FDA endorses the observed preliminary clinical benefit of these drugs, the absence of a prespecified statistical plan is a weakness of most of the published studies. Citation Format: Pedro Barata, Brian Hobbs, Brian Rini, Channing Paller, Dan Normolle, Elizabeth Garrett-Mayer, Eric Rubin, Gary Rosner, Greg Pond, Jane Perlmutter, Lesley Seymour, Lillian Siu, Nolan Wages, Percy Ivy, Tatiana Prowell, Timothy Yap, David Hong. Seamless phase I/II clinical trials in oncology: retrospective analysis of the last 7 years [abstract]. In: Proceedings of the AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics; 2017 Oct 26-30; Philadelphia, PA. Philadelphia (PA): AACR; Mol Cancer Ther 2018;17(1 Suppl):Abstract nr A100.

PECULIARITIES OF THE MORPHO-FUNCTIONAL STATUS OF YOUNG FEMALE STUDENTS ON THE COMPLIANCE FOR TYPES OF TESTING OF THE COMPLEX «READY FOR LABOR AND DEFENSE» («GOTOV K TRUDU I OBORONE» - GTO, IN RUSSIAN) 2014

Aim of the study. The identification of the variability of morphofunctional status of female students (16-20 years) between surveys in 20 years with the development of ways to optimize medical monitoring and improvement programs improving physical culture in preparation for the implementation of standards of the all-Russian sports complex «Ready for labour and defence» (ARSC GTO) in 2014. Material and methods. The normative results of the various test types and test program, the GTO period 1970-1980-ies «Ready for labor and defense of the USSR» - in 1987 and ARSC GTO - 2014. Results. For analysis and comparison for compliance with the physical health of students in the framework of preparations for civil defense (GTO), the GTO selected two different periods, the period of the USSR 1970-1980-ies that used the all Union physical culture complex «Ready for labour and defence of the USSR» (VFK GTO USSR) - 1987 period TRP in Russia - all-Russian sports complex «Ready for labour and defence» (ARSC GTO) in 2014. In the study, it was found that some kinds of testing under ARSC GTO - 2014 simpler and easier to execute (compared to the requirements of VFK GTO USSR - 1987), for example, running 100 meters, long jump, 500- and 700-gram throwing ball, ski races, cross-country, swimming and shooting. You should pay attention to the fact that the total number of trials of ARSC GTO - 2014 less than in the system VFK GTO USSR - 1987. Conclusion. Standards of performance standards of ARSC GTO - 2014 complete easier and simpler in most tests compared with the Soviet period in the framework of VFK GTO USSR - 1987. A study of anthropometric and morphofunctional characteristics of female students (16-20 years old) showed that our results require careful analysis for compliance with the physical development and health of young people aged 16-20 years with the requirements for the standards system of ARSC GTO - 2014.

QPR: An adaptive partial-report procedure based on Bayesian inference.

Iconic memory is best assessed with the partial report procedure in which an array of letters appears briefly on the screen and a poststimulus cue directs the observer to report the identity of the cued letter(s). Typically, 6–8 cue delays or 600–800 trials are tested to measure the iconic memory decay function. Here we develop a quick partial report, or qPR, procedure based on a Bayesian adaptive framework to estimate the iconic memory decay function with much reduced testing time. The iconic memory decay function is characterized by an exponential function and a joint probability distribution of its three parameters. Starting with a prior of the parameters, the method selects the stimulus to maximize the expected information gain in the next test trial. It then updates the posterior probability distribution of the parameters based on the observer's response using Bayesian inference. The procedure is reiterated until either the total number of trials or the precision of the parameter estimates reaches a certain criterion. Simulation studies showed that only 100 trials were necessary to reach an average absolute bias of 0.026 and a precision of 0.070 (both in terms of probability correct). A psychophysical validation experiment showed that estimates of the iconic memory decay function obtained with 100 qPR trials exhibited good precision (the half width of the 68.2% credible interval = 0.055) and excellent agreement with those obtained with 1,600 trials of the conventional method of constant stimuli procedure (RMSE = 0.063). Quick partial-report relieves the data collection burden in characterizing iconic memory and makes it possible to assess iconic memory in clinical populations.

A Probabilistic Approach to Receptive Field Mapping in the Frontal Eye Fields.

Studies of the neuronal mechanisms of perisaccadic vision often lack the resolution needed to determine important changes in receptive field (RF) structure. Such limited analytical power can lead to inaccurate descriptions of visuomotor processing. To address this issue, we developed a precise, probabilistic technique that uses a generalized linear model (GLM) for mapping the visual RFs of frontal eye field (FEF) neurons during stable fixation (Mayo et al., 2015). We previously found that full-field RF maps could be obtained using 1–8 dot stimuli presented at frame rates of 10–150 ms. FEF responses were generally robust to changes in the number of stimuli presented or the rate of presentation, which allowed us to visualize RFs over a range of spatial and temporal resolutions. Here, we compare the quality of RFs obtained over different stimulus and GLM parameters to facilitate future work on the detailed mapping of FEF RFs. We first evaluate the interactions between the number of stimuli presented per trial, the total number of trials, and the quality of RF mapping. Next, we vary the spatial resolution of our approach to illustrate the tradeoff between visualizing RF sub-structure and sampling at high resolutions. We then evaluate local smoothing as a possible correction for situations where under-sampling occurs. Finally, we provide a preliminary demonstration of the usefulness of a probabilistic approach for visualizing full-field perisaccadic RF shifts. Our results present a powerful, and perhaps necessary, framework for studying perisaccadic vision that is applicable to FEF and possibly other visuomotor regions of the brain.

Evidence of significant central fatigue in patients with cancer-related fatigue during repetitive elbow flexions till perceived exhaustion.

ObjectiveTo investigate whether fatigue induced by an intermittent motor task in patients with cancer-related fatigue (CRF) is more central or peripheral.MethodsTen patients with CRF who were off chemo and radiation therapies and 14 age-matched healthy controls were enrolled. Participants completed a Brief Fatigue Inventory (BFI) and performed a fatigue task consisting of intermittent elbow-flexion contractions at submaximal (40% maximal voluntary contraction) intensity till self-perceived exhaustion. Twitch force was elicited by an electrical stimulation applied to the biceps brachii muscle. The relative degree of peripheral (muscle) vs. central contribution to fatigue induced by the intermittent motor task (IMT) was assessed using twitch force ratio (TFratio) defined as post IMT twitch force to pre IMT twitch force. The total number of trials (intermittent contractions) and total duration of all trials performed by each subject were also quantified.ResultsBFI scores were higher (p<0.001) in CRF than controls, indicating greater feeling of fatigue in CRF patients than controls. A significantly smaller number of trials and shorter total duration of the trials (p<0.05) were observed in CRF than control participants. The TFratio (0.81±0.05) in CRF was higher (p<0.05) compared with that of controls (0.62±0.05), suggesting CRF patients experienced a significantly lower degree of muscle (peripheral) fatigue at the time of perceived exhaustion.ConclusionConsistent with prior findings for fatigue under submaximal sustained contraction, our results indicate that motor fatigue in CRF is more of central than peripheral origin during IMT. Significant central fatigue in CRF patients limits their ability to prolong motor performance.