scholarly journals Adherence to Ketogenic and Mediterranean Study Diets in a Crossover Trial: The Keto–Med Randomized Trial

Nutrients ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 967
Author(s):  
Matthew J. Landry ◽  
Anthony Crimarco ◽  
Dalia Perelman ◽  
Lindsay R. Durand ◽  
Christina Petlura ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Randomized Clinical Trials ◽  
Secondary Analysis ◽  
Critical Factor ◽  
Detailed Examination ◽  
Diet Patterns ◽  
Time Points ◽  
Study Results ◽  
Wide Range ◽  
Diet Pattern

Adherence is a critical factor to consider when interpreting study results from randomized clinical trials (RCTs) comparing one diet to another, but it is frequently not reported by researchers. The purpose of this secondary analysis of the Keto–Med randomized trial was to provide a detailed examination and comparison of the adherence to the two study diets (Well Formulated Ketogenic Diet (WFKD) and Mediterranean Plus (Med-Plus)) under the two conditions: all food being provided (delivered) and all food being obtained by individual participants (self-provided). Diet was assessed at six time points including baseline (x1), week 4 of each phase when participants were receiving food deliveries (x2), week 12 of each phase when participants were preparing and providing food on their own (x2), and 12 weeks after participants completed both diet phases and were free to choose their own diet pattern (x1). The adherence scores for WFKD and Med-Plus were developed specifically for this study. Average adherence to the two diet patterns was very similar during both on-study time points of the intervention. Throughout the study, a wide range of adherence was observed among participants—for both diet types and during both the delivery phase and self-provided phase. Insight from this assessment of adherence may aid other researchers when answering the important question of how to improve behavioral adherence during dietary trials. This study is registered at clinicaltrials.gov NCT03810378.

scholarly journals Meta-analysis of rare adverse events in randomized clinical trials: Bayesian and frequentist methods

2020 ◽  
pp. 174077452096913
Author(s):  
Hwanhee Hong ◽  
Chenguang Wang ◽  
Gary L Rosner
Keyword(s):  
Adverse Events ◽  
Coverage Probability ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Statistical Significance ◽  
Rare Event ◽  
Model Performance ◽  
Study Results ◽  
Wide Range ◽  
Study Heterogeneity

Background/aims: Regulatory approval of a drug or device involves an assessment of not only the benefits but also the risks of adverse events associated with the therapeutic agent. Although randomized controlled trials (RCTs) are the gold standard for evaluating effectiveness, the number of treated patients in a single RCT may not be enough to detect a rare but serious side effect of the treatment. Meta-analysis plays an important role in the evaluation of the safety of medical products and has advantage over analyzing a single RCT when estimating the rate of adverse events. Methods: In this article, we compare 15 widely used meta-analysis models under both Bayesian and frequentist frameworks when outcomes are extremely infrequent or rare. We present extensive simulation study results and then apply these methods to a real meta-analysis that considers RCTs investigating the effect of rosiglitazone on the risks of myocardial infarction and of death from cardiovascular causes. Results: Our simulation studies suggest that the beta hyperprior method modeling treatment group-specific parameters and accounting for heterogeneity performs the best. Most models ignoring between-study heterogeneity give poor coverage probability when such heterogeneity exists. In the data analysis, different methods provide a wide range of log odds ratio estimates between rosiglitazone and control treatments with a mixed conclusion on their statistical significance based on 95% confidence (or credible) intervals. Conclusion: In the rare event setting, treatment effect estimates obtained from traditional meta-analytic methods may be biased and provide poor coverage probability. This trend worsens when the data have large between-study heterogeneity. In general, we recommend methods that first estimate the summaries of treatment-specific risks across studies and then relative treatment effects based on the summaries when appropriate. Furthermore, we recommend fitting various methods, comparing the results and model performance, and investigating any significant discrepancies among them.

The Influence of Barrier and Applied Voltage Parameters on the Impulse Surface Discharge Characteristics

2020 ◽  
Vol 11 (11) ◽  
pp. 17-27
Author(s):  
Vadim V. VOEVODIN ◽  
◽  
Marina V. SOKOLOVA ◽  
Viktor R. SOLOV’YEV ◽  
Nikolay Yu. LYSOV ◽  
...  
Keyword(s):  
Applied Voltage ◽  
Voltage Pulse ◽  
Discharge Zone ◽  
Surface Discharge ◽  
Initial Surface ◽  
Barrier Material ◽  
Dielectric Barrier ◽  
Discharge Ignition ◽  
Study Results ◽  
Wide Range

The results from an experimental study of impulse surface discharge occurring in an electrode system containing a dielectric plate are presented. On one of its sides, the plate had a corona-producing electrode made of 50 mm thick copper foil grounded through a current shunt for measuring the discharge current. On its other side, the plate had a high-voltage electrode, to which the voltage from a pulse generator was applied. The article presents the results from measurements of the initial voltage and the sizes of the surface discharge area in air when applying single voltage pulses with different pulse front steepness in the range 0,1–3,4 kV/ms and amplitude in the range 7–15 kV. The measurements were carried out for different dielectric barrier materials with the e values from 2 to 35. The dielectric barrier thickness was 0,9–1,8 mm. The study results have shown that the initial surface discharge ignition voltage depends essentially on the voltage pulse parameters, whereas the barrier characteristics have a weaker effect on this voltage. It has been determined that the discharge has different discharge zone length and different structure depending on the dielectric barrier properties and applied voltage parameters. The streamer zone sizes decrease with increasing the barrier material e value at the same voltage pulse steepness and increase with increasing the steepness for each barrier material. The data obtained for a wide range of external conditions can be used in numerical modeling of discharge.

CRIMINOLOGICAL FEATURES OF CORRUPTION-RELATED CRIMES IN THE FUEL AND ENERGY COMPLEX

2020 ◽  
pp. 23-27
Author(s):  
Сергей Иванович Вележев ◽  
Антон Михайлович Седогин
Keyword(s):  
Legal Protection ◽  
Criminal Activity ◽  
Criminal Cases ◽  
Law Enforcement Agencies ◽  
Energy Complex ◽  
Significant Damage ◽  
Study Results ◽  
Wide Range ◽  
Illegal Activities ◽  
High Level

В представленной статье авторами рассматриваются вопросы уголовно-правовой охраны топливно-энергетического комплекса Российской Федерации от преступных проявлений, в том числе от коррупционной противоправной деятельности должностных лиц. Такие действия причиняют значительный ущерб нормальному функционированию предприятий топливно-энергетического комплекса. Авторами приводятся результаты исследования некоторых криминологических характеристик должностных лиц, совершивших преступления коррупционного характера. Дан анализ причин и условий, способствующих совершению вышеуказанных противоправных действий. Определена типовая модель преступника для данной категории преступлений и его характеристики: в первую очередь, это высокий уровень компетентности, специальное образование и т. д. Авторами отмечается высокий уровень латентной преступности в данной отрасли. Предложены некоторые пути профилактики данной категории правонарушений. Исследование проводилось на основе анализа конкретных уголовных дел, возбужденных следственными органами по результатам оперативно-розыскной деятельности правоохранительных органов. In the article the authors consider the issues of criminal and legal protection of the fuel and energy complex of the Russian Federation from criminal activity including corrupt illegal practices of officials. The authors cite the results of some criminological characteristics study of the fuel and energy complex staff committed corruption crimes. As a result of these illegal actions significant damage is caused to the normal functioning of the fuel and energy enterprises. Such officials` actions determine not only a wide range of other illegal activities, but also lead to public outcry and discredit the industry as a whole. The analysis of the reasons and conditions contributing to the above illegal actions commission is given. A typical model of a criminal for a given crime category and its characteristics are determined. First of all it is a high level competence, special education, etc. A high level of latent crime in this industry is shown. The study results are presented on the example of specific criminal cases initiated by the investigating authorities based on the results of the operation detection activities of law enforcement agencies. Some ways of preventing this category of offenses are proposed.

scholarly journals Environmental Flow Assessment Considering Inter- and Intra-Annual Streamflow Variability under the Context of Non-Stationarity

Water ◽  
2018 ◽  
Vol 10 (12) ◽  
pp. 1737 ◽  
Author(s):  
Kang Ren ◽  
Shengzhi Huang ◽  
Qiang Huang ◽  
Hao Wang ◽  
Guoyong Leng
Keyword(s):  
Kendall Test ◽  
Environmental Flow ◽  
Mean Value ◽  
Test Method ◽  
Stationary Condition ◽  
Annual Streamflow ◽  
Riverine Ecosystems ◽  
Study Results ◽  
Wide Range ◽  
Streamflow Variability

A key challenge to environmental flow assessment in many rivers is to evaluate how much of the discharge flow should be retained in the river in order to maintain the integrity and valued features of riverine ecosystems. With the increasing impact of climate change and human activities on riverine ecosystems, the natural flow regime paradigm in many rivers has become non-stationary conditions, which is a new challenge to the assessment of environmental flow. This study presents a useful framework to (1) detect change points in runoff time series using two statistical methods (Mann-Kendall test method and heuristic segmentation method), (2) adjust data of the changed period against the original flow series into a stationary condition using a procedure of reconstruction; and (3) incorporate inter- and intra-annual streamflow variability with adjusted streamflow to evaluate environmental flow. The Jialing to Han inter-basin water transfer project was selected as the case study. Results indicate that a change point of 1994 was identified, revealing that the stationarity of annual streamflow series is invalid. The variations of reconstructed streamflow series are roughly consistent with original streamflow series, especially in the maximum/minimum values and rise/fall rates, but the mean value of reconstructed streamflow series is increased. The reconstructed streamflow series would further serve to eliminate the non-stationary of original streamflow, and incorporating the inter- and intra-annual variability would upgrade the ecosystem fitness. Selecting different criteria for the conservation of riverine ecosystems can have significantly different consequences, and we should not focus on the protection of specific objectives that will inevitably affect other aspects. This study provides a useful framework for environmental flow assessment and can be applied to a wide range of instream flow management approaches to protect the riverine ecosystem.

scholarly journals Two-Dimensional Numerical Modeling of Flow in Physical Models of Rock Vane and Bendway Weir Configurations

Water ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 458
Author(s):  
Drew C. Baird ◽  
Benjamin Abban ◽  
S. Michael Scurlock ◽  
Steven B. Abt ◽  
Christopher I. Thornton
Keyword(s):  
Numerical Modeling ◽  
Physical Model ◽  
Numerical Models ◽  
Hydraulic Performance ◽  
Physical Models ◽  
Protection Measures ◽  
Design Engineers ◽  
Model Study ◽  
Study Results ◽  
Wide Range

While there are a wide range of design recommendations for using rock vanes and bendway weirs as streambank protection measures, no comprehensive, standard approach is currently available for design engineers to evaluate their hydraulic performance before construction. This study investigates using 2D numerical modeling as an option for predicting the hydraulic performance of rock vane and bendway weir structure designs for streambank protection. We used the Sedimentation and River Hydraulics (SRH)-2D depth-averaged numerical model to simulate flows around rock vane and bendway weir installations that were previously examined as part of a physical model study and that had water surface elevation and velocity observations. Overall, SRH-2D predicted the same general flow patterns as the physical model, but over- and underpredicted the flow velocity in some areas. These over- and underpredictions could be primarily attributed to the assumption of negligible vertical velocities. Nonetheless, the point differences between the predicted and observed velocities generally ranged from 15 to 25%, with some exceptions. The results showed that 2D numerical models could provide adequate insight into the hydraulic performance of rock vanes and bendway weirs. Accordingly, design guidance and implications of the study results are presented for design engineers.

scholarly journals MOSAIK and FMI-Based Co-Simulation Applied to Transient Stability Analysis of Grid-Forming Converter Modulated Wind Power Plants

2021 ◽  
Vol 11 (5) ◽  
pp. 2410
Author(s):  
Nakisa Farrokhseresht ◽  
Arjen A. van der Meer ◽  
José Rueda Torres ◽  
Mart A. M. M. van der Meijden
Keyword(s):  
Power System ◽  
Time Domain ◽  
Power Plants ◽  
Transient Stability ◽  
Renewable Energy Sources ◽  
Critical Factor ◽  
Primary Control ◽  
Simulation Approach ◽  
Wide Range ◽  
Grid Side

The grid integration of renewable energy sources interfaced through power electronic converters is undergoing a significant acceleration to meet environmental and political targets. The rapid deployment of converters brings new challenges in ensuring robustness, transient stability, among others. In order to enhance transient stability, transmission system operators established network grid code requirements for converter-based generators to support the primary control task during faults. A critical factor in terms of implementing grid codes is the control strategy of the grid-side converters. Grid-forming converters are a promising solution which could perform properly in a weak-grid condition as well as in an islanded operation. In order to ensure grid code compliance, a wide range of transient stability studies is required. Time-domain simulations are common practice for that purpose. However, performing traditional monolithic time domain simulations (single solver, single domain) on a converter-dominated power system is a very complex and computationally intensive task. In this paper, a co-simulation approach using the mosaik framework is applied on a power system with grid-forming converters. A validation workflow is proposed to verify the co-simulation framework. The results of comprehensive simulation studies show a proof of concept for the applicability of this co-simulation approach to evaluate the transient stability of a dominant grid-forming converter-based power system.

scholarly journals Robust Step Detection from Different Waist-Worn Sensor Positions: Implications for Clinical Studies

2020 ◽  
Vol 4 (1) ◽  
pp. 50-58
Author(s):  
Matthias  Tietsch ◽  
Amir Muaremi ◽  
Ieuan Clay ◽  
Felix Kluge ◽  
Holger Hoefling ◽  
...  
Keyword(s):  
Clinical Study ◽  
Clinical Studies ◽  
Neurological Diseases ◽  
Human Gait ◽  
Robust Solution ◽  
Step Detection ◽  
Study Protocols ◽  
Study Results ◽  
Wide Range ◽  
The Impact

Analyzing human gait with inertial sensors provides valuable insights into a wide range of health impairments, including many musculoskeletal and neurological diseases. A representative and reliable assessment of gait requires continuous monitoring over long periods and ideally takes place in the subjects’ habitual environment (real-world). An inconsistent sensor wearing position can affect gait characterization and influence clinical study results, thus clinical study protocols are typically highly proscriptive, instructing all participants to wear the sensor in a uniform manner. This restrictive approach improves data quality but reduces overall adherence. In this work, we analyze the impact of altering the sensor wearing position around the waist on sensor signal and step detection. We demonstrate that an asymmetrically worn sensor leads to additional odd-harmonic frequency components in the frequency spectrum. We propose a robust solution for step detection based on autocorrelation to overcome sensor position variation (sensitivity = 0.99, precision = 0.99). The proposed solution reduces the impact of inconsistent sensor positioning on gait characterization in clinical studies, thus providing more flexibility to protocol implementation and more freedom to participants to wear the sensor in the position most comfortable to them. This work is a first step towards truly position-agnostic gait assessment in clinical settings.

scholarly journals What makes or breaks higher education community engagement in the South African rural school context: A multiple-partner perspective

2017 ◽  
Vol 13 (2) ◽  
pp. 177-196 ◽  
Author(s):  
Eugene Gabriel Machimana ◽  
Maximus Monaheng Sefotho ◽  
Liesel Ebersöhn
Keyword(s):  
Higher Education ◽  
Service Learning ◽  
Community Engagement ◽  
School Context ◽  
Secondary Analysis ◽  
Rural School ◽  
Multiple Partner ◽  
Social Challenges ◽  
Education Community ◽  
Wide Range

The purpose of this study is to inform global citizenship practice as a higher education agenda by comparing the retrospective experiences of a range of community engagement partners and including often silent voices of non-researcher partners. Higher education–community engagement aims to contribute to social justice as it constructs and transfers new knowledge from the perspectives of a wide range of community engagement partners. This qualitative secondary analysis study was framed theoretically by the transformative–emancipatory paradigm. Existing case data, generated on retrospective experiences of community engagement partners in a long-term community engagement partnership, were conveniently sampled to analyse and compare a range of community engagement experiences ( parents of student clients ( n = 12: females 10, males 2), teachers from the partner rural school ( n = 18: females 12, males 6), student-educational psychology clients ( n = 31: females 14, males 17), Academic Service-Learning ( ASL) students ( n = 20: females 17, males 3) and researchers ( n = 12: females 11, males 1). Following thematic in-case and cross-case analysis, it emerged that all higher education–community engagement partners experienced that socio-economic challenges (defined as rural school adversities, include financial, geographic and social challenges) are addressed when an higher education–community engagement partnership exists, but that particular operational challenges (communication barriers, time constraints, workload and unclear scope, inconsistent feedback, as well as conflicting expectations) hamper higher education–community engagement partnership. A significant insight from this study is that a range of community engagement partners experience similar challenges when a university and rural school partner. All community engagement partners experienced that higher education–community engagement is challenged by the structural disparity between the rural context and operational miscommunication.

scholarly journals Foslevodopa/Foscarbidopa Is Well Tolerated and Maintains Stable Levodopa and Carbidopa Exposure Following Subcutaneous Infusion

2021 ◽  
pp. 1-8
Author(s):  
Matthew Rosebraugh ◽  
Wei Liu ◽  
Melina Neenan ◽  
Maurizio F. Facheris
Keyword(s):  
Steady State ◽  
Phase 1 ◽  
The United States ◽  
Therapeutic Window ◽  
Fixed Dose ◽  
Advanced Parkinson’S Disease ◽  
Subcutaneous Infusion ◽  
Study Results ◽  
Wide Range ◽  
Favorable Safety

Background: Foslevodopa/foscarbidopa, formerly known as ABBV-951, is a formulation of levodopa/carbidopa prodrugs with solubility that allows for subcutaneous (SC) infusion and is in development for the treatment of motor complications for patients with advanced Parkinson’s disease (aPD). Objective: The current work characterizes the levodopa (LD) and carbidopa (CD) pharmacokinetics (PK) following SC infusions of foslevodopa/foscarbidopa delivered at four different infusion rates in PD patients. Methods: This was a Phase 1, single ascending dose, single-blind study conducted in 28 adult male and female subjects at seven sites in the United States. Foslevodopa/foscarbidopa was administered via abdominal SC infusion in PD patients over 72 hours. Patients were stratified in 4 groups and received a fixed dose of foslevodopa/foscarbidopa based on their oral daily LD intake. Serial plasma PK samples were collected to assay for LD and CD concentrations. Safety and tolerability were assessed throughout the study. Results: LD exposure quickly reached steady state and remained stable with minimal fluctuations. Foslevodopa/foscarbidopa infusion provides stable LD and CD exposures compared to oral LD/CD dosing with the average steady-state exposure ranging from 747-4660 ng/mL for the different groups. Conclusion: Foslevodopa/foscarbidopa was able to provide stable LD and CD exposures in PD patients over 72 hours via SC route of delivery with very low fluctuation in LD concentration level across a wide range of clinically relevant exposures. Foslevodopa/foscarbidopa had a favorable safety profile. The low PK fluctuation following foslevodopa/foscarbidopa infusion is expected to maintain LD exposure to treat aPD patients within a narrow therapeutic window.

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