Search results for: decentralized trials
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 849

Search results for: decentralized trials

849 An Overview of Technology Availability to Support Remote Decentralized Clinical Trials

Authors: Simone Huber, Bianca Schnalzer, Baptiste Alcalde, Sten Hanke, Lampros Mpaltadoros, Thanos G. Stavropoulos, Spiros Nikolopoulos, Ioannis Kompatsiaris, Lina Pérez- Breva, Vallivana Rodrigo-Casares, Jaime Fons-Martínez, Jeroen de Bruin

Abstract:

Developing new medicine and health solutions and improving patient health currently rely on the successful execution of clinical trials, which generate relevant safety and efficacy data. For their success, recruitment and retention of participants are some of the most challenging aspects of protocol adherence. Main barriers include: i) lack of awareness of clinical trials; ii) long distance from the clinical site; iii) the burden on participants, including the duration and number of clinical visits and iv) high dropout rate. Most of these aspects could be addressed with a new paradigm, namely the Remote Decentralized Clinical Trials (RDCTs). Furthermore, the COVID-19 pandemic has highlighted additional advantages and challenges for RDCTs in practice, allowing participants to join trials from home and not depend on site visits, etc. Nevertheless, RDCTs should follow the process and the quality assurance of conventional clinical trials, which involve several processes. For each part of the trial, the Building Blocks, existing software and technologies were assessed through a systematic search. The technology needed to perform RDCTs is widely available and validated but is yet segmented and developed in silos, as different software solutions address different parts of the trial and at various levels. The current paper is analyzing the availability of technology to perform RDCTs, identifying gaps and providing an overview of Basic Building Blocks and functionalities that need to be covered to support the described processes.

Keywords: architectures and frameworks for health informatics systems, clinical trials, information and communications technology, remote decentralized clinical trials, technology availability

Procedia PDF Downloads 188
848 Leveraging Remote Assessments and Central Raters to Optimize Data Quality in Rare Neurodevelopmental Disorders Clinical Trials

Authors: Pamela Ventola, Laurel Bales, Sara Florczyk

Abstract:

Background: Fully remote or hybrid administration of clinical outcome measures in rare neurodevelopmental disorders trials is increasing due to the ongoing pandemic and recognition that remote assessments reduce the burden on families. Many assessments in rare neurodevelopmental disorders trials are complex; however, remote/hybrid trials readily allow for the use of centralized raters to administer and score the scales. The use of centralized raters has many benefits, including reducing site burden; however, a specific impact on data quality has not yet been determined. Purpose: The current study has two aims: a) evaluate differences in data quality between administration of a standardized clinical interview completed by centralized raters compared to those completed by site raters and b) evaluate improvement in accuracy of scoring standardized developmental assessments when scored centrally compared to when scored by site raters. Methods: For aim 1, the Vineland-3, a widely used measure of adaptive functioning, was administered by site raters (n= 52) participating in one of four rare disease trials. The measure was also administered as part of two additional trials that utilized central raters (n=7). Each rater completed a comprehensive training program on the assessment. Following completion of the training, each clinician completed a Vineland-3 with a mock caregiver. Administrations were recorded and reviewed by a neuropsychologist for administration and scoring accuracy. Raters were able to certify for the trials after demonstrating an accurate administration of the scale. For site raters, 25% of each rater’s in-study administrations were reviewed by a neuropsychologist for accuracy of administration and scoring. For central raters, the first two administrations and every 10th administration were reviewed. Aim 2 evaluated the added benefit of centralized scoring on the accuracy of scoring of the Bayley-3, a comprehensive developmental assessment widely used in rare neurodevelopmental disorders trials. Bayley-3 administrations across four rare disease trials were centrally scored. For all administrations, the site rater who administered the Bayley-3 scored the scale, and a centralized rater reviewed the video recordings of the administrations and also scored the scales to confirm accuracy. Results: For aim 1, site raters completed 138 Vineland-3 administrations. Of the138 administrations, 53 administrations were reviewed by a neuropsychologist. Four of the administrations had errors that compromised the validity of the assessment. The central raters completed 180 Vineland-3 administrations, 38 administrations were reviewed, and none had significant errors. For aim 2, 68 administrations of the Bayley-3 were reviewed and scored by both a site rater and a centralized rater. Of these administrations, 25 had errors in scoring that were corrected by the central rater. Conclusion: In rare neurodevelopmental disorders trials, sample sizes are often small, so data quality is critical. The use of central raters inherently decreases site burden, but it also decreases rater variance, as illustrated by the small team of central raters (n=7) needed to conduct all of the assessments (n=180) in these trials compared to the number of site raters (n=53) required for even fewer assessments (n=138). In addition, the use of central raters dramatically improves the quality of scoring the assessments.

Keywords: neurodevelopmental disorders, clinical trials, rare disease, central raters, remote trials, decentralized trials

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847 Clinical Application of Mesenchymal Stem Cells for Cancer Therapy: A Review of Registered Clinical Trials

Authors: Tuong Thi Van Thuy, Dao Van Toan, Nguyen Duc Phuc

Abstract:

Mesenchymal stem cells (MSCs) were discovered in the 1970s with their unique properties of differentiation, immunomodulation, multiple secreting, and homing factors to injured organs. MSC-based therapies have emerged as a promising strategy for various diseases such as cancer, tissue regeneration, or immunologic/inflammatory-related diseases. This study evaluated the clinical application of MSCs for cancer therapy in trials registered on Clinical Trial as of July 2022. The results showed 40 clinical trials used MSCs in various cancer conditions. 62% of trials used MSCs for therapeutic purposes to minimize the side effects of cancer treatment. Besides, 38% of trials were focused on using MSCs as a therapeutic agent to treat cancer directly. Most trials (38/40) are ongoing phase I/II, and 2 are entering phase III. 84% of trials used allogeneic MSCs compared with 13% using autologous sources and 3% using both. 25/40 trials showed participants received a single dose of MSCs, while the most times were 12 times in a pancreatic cancer treatment trial. Conclusion: MSC-based therapy for cancer in clinical trials should be applied to (1) minimize the side effects of oncological treatments and (2) directly affect the tumor via selectively delivering anti-cancer payloads to tumor cells. Allogeneic MSCs are a priority selected in clinical cancer therapy.

Keywords: mesenchymal stem cells, MSC-based therapy, cancer condition, cancer treatment, clinical trials

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846 A Biomimetic Approach for the Multi-Objective Optimization of Kinetic Façade Design

Authors: Do-Jin Jang, Sung-Ah Kim

Abstract:

A kinetic façade responds to user requirements and environmental conditions.  In designing a kinetic façade, kinetic patterns play a key role in determining its performance. This paper proposes a biomimetic method for the multi-objective optimization for kinetic façade design. The autonomous decentralized control system is combined with flocking algorithm. The flocking agents are autonomously reacting to sensor values and bring about kinetic patterns changing over time. A series of experiments were conducted to verify the potential and limitations of the flocking based decentralized control. As a result, it could show the highest performance balancing multiple objectives such as solar radiation and openness among the comparison group.

Keywords: biomimicry, flocking algorithm, autonomous decentralized control, multi-objective optimization

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845 Blockchain-Based Assignment Management System

Authors: Amogh Katti, J. Sai Asritha, D. Nivedh, M. Kalyan Srinivas, B. Somnath Chakravarthi

Abstract:

Today's modern education system uses Learning Management System (LMS) portals for the scoring and grading of student performances, to maintain student records, and teachers are instructed to accept assignments through online submissions of .pdf,.doc,.ppt, etc. There is a risk of data tampering in the traditional portals; we will apply the Blockchain model instead of this traditional model to avoid data tampering and also provide a decentralized mechanism for overall fairness. Blockchain technology is a better and also recommended model because of the following features: consensus mechanism, decentralized system, cryptographic encryption, smart contracts, Ethereum blockchain. The proposed system ensures data integrity and tamper-proof assignment submission and grading, which will be helpful for both students and also educators.

Keywords: education technology, learning management system, decentralized applications, blockchain

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844 Scalable Blockchain Solutions for NGOs: Enhancing Financial Transactions and Accountability

Authors: Aarnav Singh, Jayesh Ghatate, Tarush Pandey

Abstract:

Non-Governmental Organizations (NGOs) play a crucial role in addressing societal challenges, relying heavily on financial transactions to fund their impactful initiatives. However, traditional financial systems can be cumbersome and lack transparency, hindering the efficiency and trustworthiness of NGO operations. The Ethereum main-net, while pioneering the decentralized finance landscape, grapples with inherent scalability challenges, restricting its transaction throughput to a range of 15-45 transactions per second (TPS). This limitation poses substantial obstacles for NGOs engaging in swift and dynamic financial transactions critical to their operational efficiency. This research is a comprehensive exploration of the intricacies of these scalability challenges and delves into the design and implementation of a purpose-built blockchain system explicitly crafted to surmount these constraints.

Keywords: non-governmental organizations, decentralized system, zero knowledge Ethereum virtual machine, decentralized application

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843 Decentralized Control of Interconnected Systems with Non-Linear Unknown Interconnections

Authors: Haci Mehmet Guzey, Levent Acar

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In this paper, a novel decentralized controller is developed for linear systems with nonlinear unknown interconnections. A model linear decoupled system is assigned for each system. By using the difference actual and model state dynamics, the problem is formulated as inverse problem. Then, the interconnected dynamics are approximated by using Galerkin’s expansion method for inverse problems. Two different sets of orthogonal basis functions are utilized to approximate the interconnected dynamics. Approximated interconnections are utilized in the controller to cancel the interconnections and decouple the systems. Subsequently, the interconnected systems behave as a collection of decoupled systems.

Keywords: decentralized control, inverse problems, large scale systems, nonlinear interconnections, basis functions, system identification

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842 Farmer-Participatory Variety Trials for Tomato and Chili Pepper in East Java

Authors: Hanik Anggraeni, Evy Latifah, Putu Bagus, Joko Mariyono

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This study is to test the adaptation capacity of several selected lines and varieties of chili and tomato in farmers’ lands. Five improved lines and varieties of tomato and chili were selected based on the best performance in previous trials. Two participating farmers managed the trials. Agronomic aspects were used as performance indicators. The results show that several improved lines of tomato and chili performed better than others. However, the performance was dependent on the altitude and season. Lines performed better and high altitude could not do the same in low altitude, and vice versa. This is the same case as different season. Farmers were expected to select the best lines according to the locations.

Keywords: variety trials, tomato and chili, participatory farmers, East Java

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841 Stochastic Control of Decentralized Singularly Perturbed Systems

Authors: Walid S. Alfuhaid, Saud A. Alghamdi, John M. Watkins, M. Edwin Sawan

Abstract:

Designing a controller for stochastic decentralized interconnected large scale systems usually involves a high degree of complexity and computation ability. Noise, observability, and controllability of all system states, connectivity, and channel bandwidth are other constraints to design procedures for distributed large scale systems. The quasi-steady state model investigated in this paper is a reduced order model of the original system using singular perturbation techniques. This paper results in an optimal control synthesis to design an observer based feedback controller by standard stochastic control theory techniques using Linear Quadratic Gaussian (LQG) approach and Kalman filter design with less complexity and computation requirements. Numerical example is given at the end to demonstrate the efficiency of the proposed method.

Keywords: decentralized, optimal control, output, singular perturb

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840 Providing a Secure, Reliable and Decentralized Document Management Solution Using Blockchain by a Virtual Identity Card

Authors: Meet Shah, Ankita Aditya, Dhruv Bindra, V. S. Omkar, Aashruti Seervi

Abstract:

In today's world, we need documents everywhere for a smooth workflow in the identification process or any other security aspects. The current system and techniques which are used for identification need one thing, that is ‘proof of existence’, which involves valid documents, for example, educational, financial, etc. The main issue with the current identity access management system and digital identification process is that the system is centralized in their network, which makes it inefficient. The paper presents the system which resolves all these cited issues. It is based on ‘blockchain’ technology, which is a 'decentralized system'. It allows transactions in a decentralized and immutable manner. The primary notion of the model is to ‘have everything with nothing’. It involves inter-linking required documents of a person with a single identity card so that a person can go anywhere without having the required documents with him/her. The person just needs to be physically present at a place wherein documents are necessary, and using a fingerprint impression and an iris scan print, the rest of the verification will progress. Furthermore, some technical overheads and advancements are listed. This paper also aims to layout its far-vision scenario of blockchain and its impact on future trends.

Keywords: blockchain, decentralized system, fingerprint impression, identity management, iris scan

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839 Decentralized Data Marketplace Framework Using Blockchain-Based Smart Contract

Authors: Meshari Aljohani, Stephan Olariu, Ravi Mukkamala

Abstract:

Data is essential for enhancing the quality of life. Its value creates chances for users to profit from data sales and purchases. Users in data marketplaces, however, must share and trade data in a secure and trusted environment while maintaining their privacy. The first main contribution of this paper is to identify enabling technologies and challenges facing the development of decentralized data marketplaces. The second main contribution is to propose a decentralized data marketplace framework based on blockchain technology. The proposed framework enables sellers and buyers to transact with more confidence. Using a security deposit, the system implements a unique approach for enforcing honesty in data exchange among anonymous individuals. Before the transaction is considered complete, the system has a time frame. As a result, users can submit disputes to the arbitrators which will review them and respond with their decision. Use cases are presented to demonstrate how these technologies help data marketplaces handle issues and challenges.

Keywords: blockchain, data, data marketplace, smart contract, reputation system

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838 Culturally Adapting Videos to Involve Nigerian Patients with Cancer in Clinical Trials

Authors: Abiola Falilat Ibraheem, Akinyimika Sowunmi, Valerie Otti

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Background: Introduction of innovative cancer clinical trials to Nigeria is a critical step in addressing global inequities of cancer burden. Low health and clinical trial literacy among Nigerian patients have been sighted as a significant barrier to ensuring that patients enrolled in clinical trials are truly informed. Video intervention has been shown to be the most proactive method to improving patient’s clinical trial knowledge. In the US, video interventions have been successful at improving education about cancer clinical trials among minority patients. Thus, this study aimed to apply and adapt video interventions addressing attitudinal barriers peculiar to Nigerian patients. Methods: A hospital-based representative mixed-method study was conducted at the Lagos State University Teaching Hospital (LASUTH) from July to December 2020, comprising of cancer patients aged 18 and above. Patients were randomly selected during every clinic day, of which 63 patients volunteered to participate in this study. We first administered a cancer literacy survey to determine patients’ knowledge about clinical trials. For patients who had prior knowledge, a pre-intervention test was administered, after which a 15-minute video (attitudes and intention to enroll in therapeutic clinical trials (AIET)) to improve patients’ knowledge, perception, and attitudes towards clinical trials was played, and then ended by administering a post-intervention test to the patients. For patients who had no prior knowledge, the AIET video was played for them, followed by the post-intervention test. Results: Out of 63 patients sampled, 43 (68.3%) had breast cancer. On average, patients agreed to understand their cancer diagnosis and treatment very well. 84.1% of patients had never heard about cancer clinical trials, and 85.7% did not know what cancer clinical trials were. There was a strong positive relationship (r=0.916) between the pretest and posttest, which means that the intervention improved patients’ knowledge, perception, and attitudes about cancer clinical trials. In the focus groups, patients recommended adapting the video in Nigerian settings and representing all religions in order to address trust in local clinical trialists. Conclusion: Due to the small size of patients, change in clinical trial knowledge was not statistically significant. However, there is a trend suggesting that culturally adapted video interventions can be used to improve knowledge and perception about cancer clinical trials.

Keywords: clinical trials, culturally targeted intervention, patient education, video intervention

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837 Enhancing Robustness in Federated Learning through Decentralized Oracle Consensus and Adaptive Evaluation

Authors: Peiming Li

Abstract:

This paper presents an innovative blockchain-based approach to enhance the reliability and efficiency of federated learning systems. By integrating a decentralized oracle consensus mechanism into the federated learning framework, we address key challenges of data and model integrity. Our approach utilizes a network of redundant oracles, functioning as independent validators within an epoch-based training system in the federated learning model. In federated learning, data is decentralized, residing on various participants' devices. This scenario often leads to concerns about data integrity and model quality. Our solution employs blockchain technology to establish a transparent and tamper-proof environment, ensuring secure data sharing and aggregation. The decentralized oracles, a concept borrowed from blockchain systems, act as unbiased validators. They assess the contributions of each participant using a Hidden Markov Model (HMM), which is crucial for evaluating the consistency of participant inputs and safeguarding against model poisoning and malicious activities. Our methodology's distinct feature is its epoch-based training. An epoch here refers to a specific training phase where data is updated and assessed for quality and relevance. The redundant oracles work in concert to validate data updates during these epochs, enhancing the system's resilience to security threats and data corruption. The effectiveness of this system was tested using the Mnist dataset, a standard in machine learning for benchmarking. Results demonstrate that our blockchain-oriented federated learning approach significantly boosts system resilience, addressing the common challenges of federated environments. This paper aims to make these advanced concepts accessible, even to those with a limited background in blockchain or federated learning. We provide a foundational understanding of how blockchain technology can revolutionize data integrity in decentralized systems and explain the role of oracles in maintaining model accuracy and reliability.

Keywords: federated learning system, block chain, decentralized oracles, hidden markov model

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836 Characteristics of Domestic Sewage in Small Urban Communities

Authors: Shohreh Azizi, Memory Tekere, Wag Nel

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An evaluation of the characteristics of wastewater generated from small communities was carried out in relation to decentralized approach for domestic sewage treatment plant and design of biological nutrient removal system. The study included the survey of the waste from various individual communities such as a hotel, a residential complex, an office premise, and an educational institute. The results indicate that the concentration of organic pollutant in wastewater from the residential complex is higher than the waste from all the other communities with COD 664 mg/l, BOD 370.2 mg/l and TSS 248.8 mg/l. And the waste water from office premise indicates low organic load with COD428 mg/l, BOD 232mg/l and TSS 157mg/l. The wastewater from residential complex was studied under activated sludge process to evaluate this technology for decentralized wastewater treatment. The Activated sludge process was operated at different 12to 4 hrs hydraulic retention times and the optimum 6 hrs HRT was selected, therefore the average reduction of COD (85.92%) and BOD (91.28 %) was achieved. The issue of sludge recycling, maintenance of biomass concentration and high HRT reactor (10 L) volume are making the system non-practical for smaller communities.

Keywords: wastewater, small communities, activated sludge process, decentralized system

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835 The Effect of Sago Supplementation on Physiology and Performance in a Hot and Humid Environment

Authors: Che Jusoh, Mohd Rahimi, Toby Mundel

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This study was designed to investigate the physiological and performance effects of a local Malaysian native starch (Metroxylin sago) on cycling in a hot (30°C) and humid (78% RH) environment. Eight male, non-heat acclimated, well-trained club cyclists (VO2max 65 ± 10 ml kg-1 min-1, peak aerobic power 397 ± 71 W) completed one familiarization and three experimental trials in our laboratory simulating cycling in environmental conditions of heat and humidity. Each trial consisted of 45 minutes at a fixed workload (55% VO2max) followed by a 15 minute time-trial (~75% VO2max). Sago in porridge form was consumed 1h before exercise (Pre), in gel form during exercise (Dur) and compared to a control trial (Con), using a random, cross-over design. Plasma glucose concentration did not differ between trials (P = 0.06) with an increase from 4.1 ± 0.6 to 6.1 ± 1.6 mmol-1 (Con), 4.8 ± 1.7 to 5.7 ± 0.4 mmol-1 (Pre) and 4.7 ± 0.8 to 6.9 ± 1.4 mmol-1 (Dur) from start to end of exercise. Plasma lactate increased (P = 0.02) from 1.6 ± 0.3 to 7.6 ± 2.2 mmol-1 (Con), 1.7 ± 0.5 to 7.3 ± 2.9 mmol-1 (Pre) and 1.6 ± 0.2 to 7.3 ± 1.8 mmol-1 (Dur) with no effect of trial (P = 0.74). No differences were found between trials for RER (P = 0.328) with values of 0.93 ± 0.05 (Con), 0.94 ± 0.04 (Pre) and 0.92 ± 0.04 (Dur). There were no differences between trials in rectal (P = 0.64) and skin (P = 0.56) temperatures; values reaching 39.1 ± 0.5°C (Con), 38.9 ± 0.4°C (Pre) and 39.1 ± 0.4°C (Dur) for rectal and 32.7 ± 1.2°C (Con), 32.8 ± 1.4°C (Pre) and 32.8 ± 1.8°C (Dur) for skin temperature, respectively. Heart rate (P = 0.07) also did not differ between trials but reached maximal values by the end of time-trial for all trials. Performance was unaffected by trial (P = 0.98) with the average work completed in 15 minutes being 221 ± 33 kJ (Con), 222 ± 31 kJ (Pre) and 219 ± 32 kJ (Dur), respectively. Therefore, the results of this investigation do not support consumption of sago, either before or during exercise, in altering the thermoregulatory, metabolic or performance responses in a hot and humid environment.

Keywords: hot and humid, physiology, time trial performance, thermoregulatory

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834 Irrelevant Angry Faces, Compared to Happy Faces, Facilitate the Response Inhibition

Authors: Rashmi Gupta

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It is unclear whether arousal or valence modulates the response inhibition process. It has been suggested that irrelevant positive emotional information (e.g., happy faces) and negative emotional information (e.g., angry faces) interact with attention differently. In the present study, we used arousal-matched irrelevant happy and angry faces. These faces were used as stop-signals in the stop-signal paradigm. There were two kinds of trials: go-trials and stop-trials. Participants were required to discriminate between the letter X or O by pressing the corresponding keys on go-trials. However, a stop signal was occasionally presented on stop trials, where participants were required to withhold their motor response. A significant main effect of emotion on response inhibition was observed. It indicated that the valence of a stop signal modulates inhibitory control. We found that stop-signal reaction time was faster in response to irrelevant angry faces than happy faces, indicating that irrelevant angry faces facilitate the response inhibition process compared to happy faces. These results shed light on the interaction of emotion with cognitive control functions.

Keywords: attention, emotion, response inhibition, inhibitory control

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833 A Review of Methods for Handling Missing Data in the Formof Dropouts in Longitudinal Clinical Trials

Authors: A. Satty, H. Mwambi

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Much clinical trials data-based research are characterized by the unavoidable problem of dropout as a result of missing or erroneous values. This paper aims to review some of the various techniques to address the dropout problems in longitudinal clinical trials. The fundamental concepts of the patterns and mechanisms of dropout are discussed. This study presents five general techniques for handling dropout: (1) Deletion methods; (2) Imputation-based methods; (3) Data augmentation methods; (4) Likelihood-based methods; and (5) MNAR-based methods. Under each technique, several methods that are commonly used to deal with dropout are presented, including a review of the existing literature in which we examine the effectiveness of these methods in the analysis of incomplete data. Two application examples are presented to study the potential strengths or weaknesses of some of the methods under certain dropout mechanisms as well as to assess the sensitivity of the modelling assumptions.

Keywords: incomplete longitudinal clinical trials, missing at random (MAR), imputation, weighting methods, sensitivity analysis

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832 Conjugated Linoleic Acid Effect on Body Weight and Body Composition in Women: Systematic Review and Meta-Analysis

Authors: Hanady Hamdallah, H. Elyse Ireland, John H. H. Williams

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Conjugated linoleic acid (CLA) is a food supplement that is reported to have multiple beneficial health effects, including being anti-carcinogenic, anti-inflammatory and anti-obesity. Animal studies have shown a significant anti-obesity effect of CLA, but results in humans were inconsistent, where some of the studies found an anti-obesity effect while other studies failed to find any decline in obesity markers after CLA supplementation. This meta-analysis aimed to determine if oral CLA supplementation has been shown to reduce obesity related markers in women. Pub Med, Cochrane Library, and Google Scholar were used to identify the eligible trials using two main searching strategies: the first one was to search eligible trials using keywords 'Conjugated linoleic acid', 'CLA', 'Women', and the second strategy was to extract the eligible trials from previously published systematic reviews and meta-analyses. The eligible trials were placebo control trials where women supplemented with CLA mixture in the form of oral capsules for 6 months or less. Also, these trials provided information about body composition expressed as body weight (BW), body mass index (BMI), total body fat (TBF), percentage body fat (BF %), and/ or lean body mass (LBM). The quality of each included study was assessed using both JADAD scale and an adapted CONSERT checklist. Meta-analysis of 8 eligible trials showed that CLA supplementation was significantly associated with reduced BW (Mean ± SD, 1.2 ± 0.26 kg, p < 0.001), BMI (0.6 ± 0.13kg/m², p < 0.001) and TBF (0.76 ± 0.26 kg, p= 0.003) in women, when supplemented over 6-16 weeks. Subgroup meta-analysis demonstrated a significant reduction in BW (1.29 ± 0.31 kg, p < 0.001), BMI (0.60 ± 0.14 kg/m², p < 0.001) and TBF (0.82 ± 0.28 kg, p= 0.003) in the trials that had recruited overweight-obese women. The second subgroup meta-analysis, that considered the menopausal status of the participants, found that CLA was significantly associated with reduced BW (1.35 ± 0.37 kg, p < 0.001; 1.05 ± 0.36 kg, p= 0.003) and BMI (0.50 ± 0.17 kg/m², p= 0.003; 0.75 ± 0.2 kg/m², p < 0.001) in both pre and post-menopausal age women, respectively. A reduction in TBF (1.09 ± 0.37 kg, p= 0.003) was only significant in post-menopausal women. Interestingly, CLA supplementation was associated with a significant reduction in BW (1.05 ± 0.35 kg, p< 0.003), BMI (0.73 ± 0.2 kg/m², p < 0.001) and TBF (1.07 ± 0.36 kg, p= 0.003) in the trials without lifestyle monitoring or interventions. No significant effect of CLA on LBM was detected in this meta-analysis. This meta-analysis suggests a moderate anti-obesity effect of CLA on BW, BMI and TBF reduction in women, when supplemented over 6-16 weeks, particularly in overweight-obese women and post-menopausal women. However, this finding requires careful interpretation due to several issues in the designs of available CLA supplementation trials. More well-designed trials are required to confirm this meta-analysis results.

Keywords: body composition, body mass index, body weight, conjugated linoleic acid

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831 Decentralized Wastewater Treatment in Coastal Touristic Areas Using Standardized Modular Biological Filtration (SMBF)

Authors: Andreas Rüdiger

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The selection of appropriate wastewater treatment technology for decentralized coastal tourist areas is an important engineering challenge. The local situation in coastal tourist cities and villages is characterized by important daily and seasonal fluctuations in hydraulic flow and pollution, high annual temperature variations, scarcity of building area and high housing density. At the same time, coastal zones have to meet stringent effluent limits all over the year and need simple and easy technologies to operate. This article presents the innovative technology of standardized modular aerated up-flow biofiltration SMBF as an adapted solution for decentralized wastewater treatment in sensitive touristic coastal areas. As modular technology with several biofiltration units, the system is able to treat low and high loads with low energy consumption and low demands for operators. The article focuses on the climatic and tourist situation in Croatia. Full-scale plants in Eastern Europe and Croatia have presented as well as dimensioning parameters and outlet concentrations. Energy consumption as a function of load is demonstrated.

Keywords: wastewater treatment, biofiltration, touristic areas, energy saving

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830 Integrated Wastewater Reuse Project of the Faculty of Sciences AinChock, Morocco

Authors: Nihad Chakri, Btissam El Amrani, Faouzi Berrada, Fouad Amraoui

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In Morocco, water scarcity requires the exploitation of non-conventional resources. Rural areas are under-equipped with sanitation infrastructure, unlike urban areas. Decentralized and low-cost solutions could improve the quality of life of the population and the environment. In this context, the Faculty of Sciences Ain Chock "FSAC" has undertaken an integrated project to treat part of its wastewater using a decentralized compact system. The project will propose alternative solutions that are inexpensive and adapted to the context of peri-urban and rural areas in order to treat the wastewater generated and use it for irrigation, watering, and cleaning. For this purpose, several tests were carried out in the laboratory in order to develop a liquid waste treatment system optimized for local conditions. Based on the results obtained at the laboratory scale of the different proposed scenarios, we designed and implemented a prototype of a mini wastewater treatment plant for the Faculty. In this article, we will outline the steps of dimensioning, construction, and monitoring of the mini-station in our Faculty.

Keywords: wastewater, purification, optimization, vertical filter, MBBR process, sizing, decentralized pilot, reuse, irrigation, sustainable development

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829 Competing Risk Analyses in Survival Trials During COVID-19 Pandemic

Authors: Ping Xu, Gregory T. Golm, Guanghan (Frank) Liu

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In the presence of competing events, traditional survival analysis may not be appropriate and can result in biased estimates, as it assumes independence between competing events and the event of interest. Instead, competing risk analysis should be considered to correctly estimate the survival probability of the event of interest and the hazard ratio between treatment groups. The COVID-19 pandemic has provided a potential source of competing risks in clinical trials, as participants in trials may experienceCOVID-related competing events before the occurrence of the event of interest, for instance, death due to COVID-19, which can affect the incidence rate of the event of interest. We have performed simulation studies to compare multiple competing risk analysis models, including the cumulative incidence function, the sub-distribution hazard function, and the cause-specific hazard function, to the traditional survival analysis model under various scenarios. We also provide a general recommendation on conducting competing risk analysis in randomized clinical trials during the era of the COVID-19 pandemic based on the extensive simulation results.

Keywords: competing risk, survival analysis, simulations, randomized clinical trial, COVID-19 pandemic

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828 Epigenetic Drugs for Major Depressive Disorder: A Critical Appraisal of Available Studies

Authors: Aniket Kumar, Jacob Peedicayil

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Major depressive disorder (MDD) is a common and important psychiatric disorder. Several clinical features of MDD suggest an epigenetic basis for its pathogenesis. Since epigenetics (heritable changes in gene expression not involving changes in DNA sequence) may underlie the pathogenesis of MDD, epigenetic drugs such as DNA methyltransferase inhibitors (DNMTi) and histone deactylase inhibitors (HDACi) may be useful for treating MDD. The available literature indexed in Pubmed on preclinical drug trials of epigenetic drugs for the treatment of MDD was investigated. The search terms we used were ‘depression’ or ‘depressive’ and ‘HDACi’ or ‘DNMTi’. Among epigenetic drugs, it was found that there were 3 preclinical trials using HDACi and 3 using DNMTi for the treatment of MDD. All the trials were conducted on rodents (mice or rats). The animal models of depression that were used were: learned helplessness-induced animal model, forced swim test, open field test, and the tail suspension test. One study used a genetic rat model of depression (the Flinders Sensitive Line). The HDACi that were tested were: sodium butyrate, compound 60 (Cpd-60), and valproic acid. The DNMTi that were tested were: 5-azacytidine and decitabine. Among the three preclinical trials using HDACi, all showed an antidepressant effect in animal models of depression. Among the 3 preclinical trials using DNMTi also, all showed an antidepressant effect in animal models of depression. Thus, epigenetic drugs, namely, HDACi and DNMTi, may prove to be useful in the treatment of MDD and merit further investigation for the treatment of this disorder.

Keywords: DNA methylation, drug discovery, epigenetics, major depressive disorder

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827 Odor-Color Association Stroop-Task and the Importance of an Odorant in an Odor-Imagery Task

Authors: Jonathan Ham, Christopher Koch

Abstract:

There are consistently observed associations between certain odors and colors, and there is an association between the ability to imagine vivid visual objects and imagine vivid odors. However, little has been done to investigate how the associations between odors and visual information effect visual processes. This study seeks to understand the relationship between odor imaging, color associations, and visual attention by utilizing a Stroop-task based on common odor-color associations. This Stroop-task was designed using three fruits with distinct odors that are associated with the color of the fruit: lime with green, strawberry with red, and lemon with yellow. Each possible word-color combination was presented in the experimental trials. When the word matched the associated color (lime written in green) it was considered congruent; if it did not, it was considered incongruent (lime written in red or yellow). In experiment I (n = 34) participants were asked to both imagine the odor of the fruit on the screen and identify which fruit it was, and each word-color combination was presented 20 times (a total of 180 trials, with 60 congruent and 120 incongruent instances). Response time and error rate of the participant responses were recorded. There was no significant difference in either measure between the congruent and incongruent trials. In experiment II participants (n = 18) followed the identical procedure as in the previous experiment with the addition of an odorant in the room. The odorant (orange) was not the fruit or color used in the experimental trials. With a fruit-based odorant in the room, the response times (measured in milliseconds) between congruent and incongruent trials were significantly different, with incongruent trials (M = 755.919, SD = 239.854) having significantly longer response times than congruent trials (M = 690.626, SD = 198.822), t (1, 17) = 4.154, p < 0.01. This suggests that odor imagery does affect visual attention to colors, and the ability to inhibit odor-color associations; however, odor imagery is difficult and appears to be facilitated in the presence of a related odorant.

Keywords: odor-color associations, odor imagery, visual attention, inhibition

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826 Building a Blockchain-based Internet of Things

Authors: Rob van den Dam

Abstract:

Today’s Internet of Things (IoT) comprises more than a billion intelligent devices, connected via wired/wireless communications. The expected proliferation of hundreds of billions more places us at the threshold of a transformation sweeping across the communications industry. Yet, we found that the IoT architecture and solutions that currently work for billions of devices won’t necessarily scale to tomorrow’s hundreds of billions of devices because of high cost, lack of privacy, not future-proof, lack of functional value and broken business models. As the IoT scales exponentially, decentralized networks have the potential to reduce infrastructure and maintenance costs to manufacturers. Decentralization also promises increased robustness by removing single points of failure that could exist in traditional centralized networks. By shifting the power in the network from the center to the edges, devices gain greater autonomy and can become points of transactions and economic value creation for owners and users. To validate the underlying technology vision, IBM jointly developed with Samsung Electronics the autonomous decentralized peer-to- peer proof-of-concept (PoC). The primary objective of this PoC was to establish a foundation on which to demonstrate several capabilities that are fundamental to building a decentralized IoT. Though many commercial systems in the future will exist as hybrid centralized-decentralized models, the PoC demonstrated a fully distributed proof. The PoC (a) validated the future vision for decentralized systems to extensively augment today’s centralized solutions, (b) demonstrated foundational IoT tasks without the use of centralized control, (c) proved that empowered devices can engage autonomously in marketplace transactions. The PoC opens the door for the communications and electronics industry to further explore the challenges and opportunities of potential hybrid models that can address the complexity and variety of requirements posed by the internet that continues to scale. Contents: (a) The new approach for an IoT that will be secure and scalable, (b) The three foundational technologies that are key for the future IoT, (c) The related business models and user experiences, (d) How such an IoT will create an 'Economy of Things', (e) The role of users, devices, and industries in the IoT future, (f) The winners in the IoT economy.

Keywords: IoT, internet, wired, wireless

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825 Study of Personality, Fear of Negative Evaluation and Life-Orientation in Convicts and Under-Trials

Authors: Sneh Laller, Kamini C. Tanwar

Abstract:

Human beings are social animals. The scenario is changing and people become angry towards petty things and this may lead to committing a crime. Objective: The aim of the present research is: 1. To find out the difference between convicts and under-trials on different dimensions of Personality, Fear of Negative Evaluation (FNE) and Life-orientation; 2. To find out the difference between male and female jail inmates on different dimensions of Personality, Fear of Negative Evaluation (FNE) and Life-orientation; 3. To find out the relationship between different dimensions of Personality, Fear of Negative Evaluation (FNE) and Life-orientation in convicts and under-trials; 4. To find out the relationship between different dimensions of Personality, Fear of Negative Evaluation (FNE) and Life-orientation in male and female jail inmates. Method: The study was conducted on 100 participants (consisting of 50 convicts- 25 males and 25 females, and 50 under-trials- 25 males and 25 females); age range was 20-60 years. The NEO Five-Factor Inventory-3 by McCrae, Costa (2010), Brief Fear of Negative Evaluation scale- II by Leary (1983) and Life Orientation Test-R by Scheier et al. (1994) was used and purposive sampling technique was done for data collection. The t-test was applied to find out the comparison and Pearson correlation was applied to determine the relationship between personality, FNE and life-orientation in both the groups. Results: There is a significant difference in the dimension of personality that is neuroticism and life-orientation in convicts and under-trials and also, in the dimensions of personality such as neuroticism, extraversion, openness to experience and agreeableness, and FNE in male and female jail inmates. In convicts the dimension of personality, agreeableness shows significant positive correlation with life-orientation (r = 0.430**) whereas, in under-trials the dimension of personality, agreeableness shows significant positive correlation with FNE (r = 0.315*) and another dimension of personality, extraversion shows significant negative correlation with life-orientation (r = -0.409**). In male jail inmates, the dimension of personality, agreeableness shows significant positive correlation with FNE (r = 0.474**) whereas in female jail inmates, the dimension of personality, openness to experience shows significant negative correlation with FNE (r = -0.356*) and significant positive correlation of neuroticism with life-orientation (r = 0.292*). Conclusion: It was found that under-trials are neurotic and life-oriented than convicts, and female jail inmates are also neurotic and exhibit fear of negative evaluation whereas male jail inmates are extravert and agreeable.

Keywords: convicts, fear of negative evaluation, life-orientation, personality, under-trials

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824 Fault Detection and Isolation in Attitude Control Subsystem of Spacecraft Formation Flying Using Extended Kalman Filters

Authors: S. Ghasemi, K. Khorasani

Abstract:

In this paper, the problem of fault detection and isolation in the attitude control subsystem of spacecraft formation flying is considered. In order to design the fault detection method, an extended Kalman filter is utilized which is a nonlinear stochastic state estimation method. Three fault detection architectures, namely, centralized, decentralized, and semi-decentralized are designed based on the extended Kalman filters. Moreover, the residual generation and threshold selection techniques are proposed for these architectures.

Keywords: component, formation flight of satellites, extended Kalman filter, fault detection and isolation, actuator fault

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823 Does Mirror Therapy Improve Motor Recovery After Stroke? A Meta-Analysis of Randomized Controlled Trials

Authors: Hassan Abo Salem, Guo Feng, Xiaolin Huang

Abstract:

The objective of this study is to determine the effectiveness of mirror therapy on motor recovery and functional abilities after stroke. The following databases were searched from inception to May 2014: Cochrane Stroke, Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CINAHL, AMED, PsycINFO, and PEDro. Two reviewers independently screened and selected all randomized controlled trials that evaluate the effect of mirror therapy in stroke rehabilitation.12 randomized controlled trials studies met the inclusion criteria; 10 studies utilized the effect of mirror therapy for the upper limb and 2 studies for the lower limb. Mirror therapy had a positive effect on motor recover and function; however, we found no consistent influence on activity of daily living, Spasticity and balance. This meta-analysis suggests that, Mirror therapy has additional effect on motor recovery but has a small positive effect on functional abilities after stroke. Further high-quality studies with greater statistical power are required in order to accurately determine the effectiveness of mirror therapy following stroke.

Keywords: mirror therapy, motor recovery, stroke, balance

Procedia PDF Downloads 528
822 Together - A Decentralized Application Connects Ideas and Investors

Authors: Chandragiri Nagadeep, M. V. V. S. Durga, Sadu Mahikshith

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Future generation is depended on new ideas and innovations that develops the country economical growth and technology standards so, Startups plays an important role in satisfying above goals. Startups includes support which is given by investing into it by investors but, single digit investors can’t keep supporting one startup and lot of security problems occurs while transferring large funds to startup’s bank account. Targeting security and most supportive funding, TogEther solves these issues by providing a platform where “Crowd Funding” is available in a decentralized way such that funding is done with digital currency called cryptocurrency where transactions are done in a secured way using “Block Chain Technology”. Not only Funding but also Ideas along with their documents can be presented and hosted with help of IPFS (Inter Planetary File System).

Keywords: blockchain, ethereum, web3, reactjs, interplanetary file system, funding

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821 The Effect of Vitamin D Supplementation on Prostate Cancer: A Systematic Review and Meta-Analysis of Clinical Trials

Authors: Simin Shahvazi, Sepideh Soltani, Seyed Mehdi Ahmadi, Russell J. De Souza, Amin Salehi-Abargouei

Abstract:

Background and Objectives: Vitamin D has received attention for its potential to disrupt cancer processes such as attenuating cell proliferation and exacerbating differentiation and apoptosis. However, whether there exists a role for vitamin D in the treatment of prostate cancer specifically remains controversial. We systematically review the literature to assess whether supplementation with vitamin D influences PSA response and overall survival in patients with prostate cancer. Methods: We searched PubMed, Scopus, ISI Web of Science and Google scholar from inception through up to 10 September 2017 for both before-and-after and randomized trials that evaluated the effect of vitamin D supplementation on the prostate specific antigen (PSA) response rate in participants with prostate cancer. The DerSimonian and Laird, inverse-weighted random-effects model was used to pool effect estimates from the studies. Heterogeneity and potential publication bias were evaluated. Subgroup analyses were also performed. Results: Twenty-two studies (16 before-after and 6 randomized controlled trials) were found and included in meta-analysis. The analysis on controlled clinical trials revealed that PSA change from baseline [weighted mean difference (WMD) = -1.66 ng/ml, 95%CI: -0.69, 0.36, P= 0.543)], PSA response (RR=1.18, 95%CI: 0.97, 1.45, P=0.104) and mortality rate (risk ratio (RR) = 1.05, 95% CI: 0.81-1.36; P=0.713) was not significantly different between vitamin D supplementation and placebo groups. Single arm trials revealed that vitamin D supplementation had had a modest effect on PSA response rate: 19% of those enrolled had at least a 50% reduction in PSA by the end of treatment (95% CI: 7% to 31%; p=0.002). Conclusion: We found that vitamin D modestly increases the PSA response rate in single arm studies. No effect on serum PSA levels, PSA response and mortality was seen in randomized controlled clinical trials. It does not seem patients with prostate cancer benefit from vitamin D supplementation.

Keywords: mortality, prostatic neoplasms, PSA response, vitamin D

Procedia PDF Downloads 172
820 Invention of Novel Technique of Process Scale Up by Using Solid Dosage Form

Authors: Shashank Tiwari, S. P. Mahapatra

Abstract:

The aim of this technique is to reduce the steps of process scales up, save time & cost of the industries. This technique will minimise the steps of process scale up. The new steps are, Novel Lab Scale, Novel Lab Scale Trials, Novel Trial Batches, Novel Exhibit Batches, Novel Validation Batches. In these steps, it is not divided to validation batches in three parts but the data of trials batches, Exhibit Batches and Validation batches are use and compile for production and used for validation. It also increases the batch size of the trial, exhibit batches. The new size of trials batches is not less than fifty Thousand, the exhibit batches increase up to two lack and the validation batches up to five lack. After preparing the batches all their data & drugs use for stability & maintain the validation record and compile data for the technology transfer in production department for preparing the marketed size batches.

Keywords: batches, technique, preparation, scale up, validation

Procedia PDF Downloads 333