Registration Phase Research Articles

BSIF: Blockchain-Based Secure, Interactive, and Fair Mobile Crowdsensing

Given the explosive growth of portable devices, mobile crowdsensing (MCS) is becoming an essential approach that fully utilizes pervasive idle resources to accomplish sensing tasks. The traditional MCS relies on the centralized server for task handle is susceptible to a single point of failure. Targeting this security issue, researchers have proposed a series of blockchain-based MCS. However, nodes in the blockchain suffer from high computation cost for data processing. Simultaneously, most blockchain-based MCS systems lack an efficient incentive mechanism for service requesters and workers. In this work, we integrate the smart contract and mobile devices to establish a secure, interactive, and fair blockchain-based MCS system called BSIF. To prevent illegitimate participants, BSIF requests all users to verify their identities using private keys from the registration phase. In the case of worker location privacy leakage, the location-based symmetric key generator is adopted to coordinate a session key for target range worker selection. Besides, we transfer the data evaluation process to the requester side (e.g., a personal computer), reducing computation cost in the blockchain nodes. Due to the homomorphic feature of the Paillier Cryptosystem and common interest, the requester cannot violate the directives from the blockchain. Subsequently, the Stackelberg game is adopted to investigate the participation level of the workers and the fair reward mechanism for the requesters to achieve a dynamic balance. Finally, the security analysis and performance evaluation demonstrate that our BSIF can defend against possible adversaries while significantly cutting overhead and giving participants the utmost incentive.

62MO Naxitamab pivotal clinical trial planned interim analysis of PFS and OS in patients with relapsed or refractory high-risk neuroblastoma

Naxitamab (NAX) is a humanized GD2-binding monoclonal antibody approved in the US with granulocyte-macrophage colony-stimulating factor (GM-CSF) under accelerated approval based in part on ad hoc analysis of data from the registrational phase II 201 trial (NCT03363373). We report progression free (PFS) and overall survival (OS) results of prespecified interim analyses.

Polatuzumab- Rituximab with or without Bendamustine As Second-Line Therapy for Relapsed Refractory Large B-Cell Lymphomas: Single Center Experience

Introduction: Polatuzumab-vedotin, a CD79 antibody drug conjugate, is approved in combination with bendamustine and rituximab (Pola-BR) in patients with relapsed or refractory (R/R) Large B-cell Lymphoma (LBCL) who have received at least 2 prior lines of therapy. However, the registrational phase Ib/II study by Dr. Sehn and colleagues (Sehn et al. J Clin Oncol 2019) included 11 patients treated with this regimen as second line (2L) therapy. Given these data, real world applications have included the use of 2L polatuzumab rituximab (Pola-R) combination, with or without bendamustine, either as stand-alone treatment or as a bridge to cellular therapy. Here, we sought to analyze institutional outcomes of LBCL patients treated with this regimen and to determine whether the pattern of failure to frontline chemoimmunotherapy (1L CIT) was associated with subsequent response to polatuzumab containing regimen. Methods: We retrospectively reviewed data on 22 patients who received Pola-R with or without bendamustine as 2L therapy for LBCL at Miami Cancer Institute as of January 31st, 2022. Response was assessed by investigators using the Lugano criteria (Cheson et al. J Clin Oncol 2014). Objective response rate (ORR) and complete response (CR) rates were compared between primary refractory (no CR to 1L CIT) and relapsed LBCL patients. Progression free survival (PFS) and overall survival (OS) were estimated using the Kaplan-Meier method. Results: Baseline characteristics are summarized in Table 1. The median age was 73 years (range, 57 to 92). Seven (32%) patients were ≥80 years old. The majority of patients (54%) had de novo DLBCL and non-GCB (59%) cell of origin by Hans algorithm. The median number of polatuzumab cycles was 4 (range, 1 to 7 cycles). Pola-BR was initiated with full dose bendamustine for 14 (64%) patients. Bendamustine was omitted for 6 (27%) patients and 2 (9%) patients received both Pola-R and Pola-BR cycles. The investigator-assessed best ORR was 68% (95% confidence interval [CI], 48.7% to 87.6%). Fourteen (64%) patients achieved a CR. Of the 6 patients who received Pola-R, 67% achieved a CR. The ORR was 90% for patients with relapsed disease, and 40% for those with primary refractory disease (p=0.057). CR rates were significantly lower in patients with disease refractory to 1L CIT (p=0.019). Median follow-up was 11 months. Nine (41%) patients received cellular therapy after polatuzumab containing regimen. Of these, 4 patients received CD19 targeted CAR T-cell therapy, and 5 patients received high dose chemotherapy followed by autologous stem cell transplant (ASCT). Other subsequent therapies after polatuzumab were: tafasitamab plus lenalidomide (n=1), loncastuximab tesirine (n=1) and conventional salvage CIT (n=3). Median PFS and OS were not reached. The 1-year PFS and OS were 54.5% (95% CI, 32.1% to 76.9%) and 70.5% (95% CI, 47.6% to 93.4%), respectively. Progression free survival and overall survival estimates are shown in Figure 1. Conclusions: Polatuzumab-Rituximab with or without bendamustine is an effective salvage option for R/R LBCL patients in the second-line setting. Refractoriness to frontline CIT was associated with lower response to subsequent polatuzumab treatment. Patients treated with this regimen can be successfully bridged to cellular approaches as definitive therapy. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

An improved biometric based user authentication and key agreement scheme for intelligent sensor based wireless communication

The new communication technologies have changed the traditional networks processes and provides more feasible, and convenient services for healthcare, agriculture, and transportation. Ad hoc networks devices have limited resources for energy, storage and processing. The conventional and traditional security solutions are not suitable for small and tiny sensor nodes. The symmetric cryptography method consumes more energy than public key cryptography method, whereas the public key cryptography method is a resource-intensive and not suitable for wireless networks. The symmetric cryptosystems have key management issues. Different authentication mechanisms have been designed but almost all of them are either complex or insecure. Improving network security with less resources consumption, there is a need to design and develop more advance and lightweight solution. This paper proposed a Biometric based User Authentication and Key Agreement Protocol (BUAKA) that uses a fuzzy extractor and one-way hash functions for sensor nodes authentication. The proposed scheme has four phases: initialization, registration, authentication, and password renewal phase. The proposed scheme resolves the complexities issues by providing a secure authentication mechanism and provide great resilience against a number of attacks. Finally, the proposed scheme is evaluated using several parameters such as security attacks, computational cost, and communication overhead to measure the effectiveness of proposed scheme.

Probability of Study Success (PrSS) Evaluation Based on Multiple Endpoints in Late Phase Oncology Drug Development

Phase 2 Oncology clinical trials are increasingly designed with multiple primary endpoints, such as progression-free survival (PFS) and overall survival (OS). While this gives a clearer picture of treatment benefit than trials with a single endpoint, it complicates the decision to begin a registration (phase 3) trial following a phase 2 trial. Methods for calculating the probability of study success (PrSS) assume the distribution of OS is well understood, but rarely consider the case of multiple primary endpoints. We introduce the BAMBOO method (BAyesian Model that Brings phase 2 cOmposite endpOints) to address this gap. We propose modeling the phase 2 log hazard ratios for PFS and OS as a bivariate normal random variable, with the unknown correlation parameter estimated with a meta-analysis or via simulation. The PrSS of a phase 3 study with multiple primary endpoints study can then be obtained using the posterior predictive distribution of this bivariate normal random variable. We provide methods to include additional surrogate endpoints, such as objective response rate, by extending the model to a multivariate normal of arbitrary dimension. Simulation results suggest the proposed method can better address the known prior-data conflict issue comparing to existing approaches, while borrowing historical data with caution is generally recommended under high discrepancy and small sample size. Finally, we provide an example of how BAMBOO can aid in planning a phase 3 trial.

209 (PB089) - Update from the ongoing phase 1/2 registrational trial of repotrectinib: results in TKI-naïve and TKI-pretreated patients with NTRK fusion-positive advanced solid tumors (TRIDENT-1)

Background: Repotrectinib is a selective, highly potent, next-generation ROS1 and TRK inhibitor that is currently under evaluation in the global registrational phase 1/2 TRIDENT-1 trial. Early clinical data from the TRIDENT-1 trial was presented in a plenary session at the 2021 AACR-NCI-EORTC conference. Repotrectinib was generally well tolerated. In NTRK fusion-positive tyrosine kinase inhibitor (TKI)-naïve (expansion cohort [EXP]-5) and TRK TKI-pretreated (EXP-6) patients with advanced solid tumors, confirmed overall response rates (cORR) per investigator assessment were 41% (95% CI: 18–67) and 48% (95% CI: 27–69), respectively.

891P Naxitamab treatment for relapsed or refractory high-risk neuroblastoma: Outcomes from the first prespecified analyses of the Pivotal 201 Trial

Naxitamab is a humanized GD2-binding monoclonal antibody approved in the US with GM-CSF for the treatment of relapsed/refractory high-risk neuroblastoma (HR-NB) in the bone/bone marrow (BM). This accelerated approval was based in part on an ad hoc analysis of data from the registrational phase II 201 trial (NCT03363373). Here we report the first results of a prespecified analysis from this same trial. Trial 201 is an ongoing phase II trial evaluating naxitamab+GM-CSF in patients with relapsed/refractory HR-NB with residual disease limited to bone/BM. Patients with progressive or residual soft tissue disease were not eligible. Naxitamab was administered over 30-60 min in the outpatient setting on Days 1/3/5 with GM-CSF on Days –4 to 5; cycles were 28 days. Efficacy was evaluated by independent pathology and radiology review per revised International Neuroblastoma Response Criteria. Assuming an actual overall response rate (ORR; complete response [CR] + partial response [PR]) of 45%, a sample size of 37 patients was considered sufficient to ensure ≥90% power to exclude an overall response rate of ≤20% at an α-level of 0.05. At data cutoff (Dec 31, 2021) there were 52 patients in the efficacy population and 74 in safety. The ORR was 50.0% (26/52; 95% CI 36-64%) with a CR rate of 38.5% (95% CI 25-53%). The trial met the primary endpoint for the prespecified analysis as the lower 95% CI for ORR was >20%. Disease control rate (CR+PR+minor response+stable disease) was 78.8% (41/52; 95% CI 65-89%) The adverse event (AE) profile was like previous reports with most being infusion-related reactions including hypotension and pain. 44.6% (33/74) of patients experienced ≥1 treatment-emergent serious AE; 6.8% (5/74) patients discontinued naxitamab due to treatment-emergent AEs. There were no deaths related to naxitamab. Based on this prespecified analysis, naxitamab provides a significant and clinically relevant response in patients with relapsed/refractory HR-NB limited to bone/BM – frequent sites of residual disease. These efficacy results combined with a manageable safety profile demonstrate that naxitamab addresses a significant unmet medical need.

Monitoring lipid phase transition temperatures using fluorescent probes and temperature-dependent fluorescence spectroscopy

The response of fluorescent dyes incorporated in multilamellar liposomes was evaluated for their applicability in monitoring thermal-induced changes in liposomes. Five fluorescent probes, diverse in polarity, lipophilicity, and consequently their position within the lipid multibilayers constituted from 1,2-dipalmitoyl-sn-glycero-3-phosphocholine (DPPC), were used to record temperature-dependent fluorescence spectra of the liposomal suspensions. The responses of the dyes were analysed in a multivariate fashion to determine pre- and main phase transition temperatures of DPPC. Laurdan® and 1-chloro-9,10-bis(phenylethynyl)anthracene register both phase transitions, while 9,10-diphenylanthracene and 9,10-bis(phenylethynyl)anthracene report only pretransition. According to the differential scanning calorimetry (DSC) measurements, all suspensions display both phase transitions that resemble DSC curve of pure DPPC. The positions of the dyes within the bilayers were determined by molecular dynamics simulations.

Next Step in Incretin-Based Therapy: From Single to Dual Agonism

The twin epidemics of Type 2 diabetes (T2D) and obesity will continue to bring significant health challenges in the coming decades. Randomised controlled trials of glucagon-like peptide 1 (GLP-1)-based therapies showed high glycaemic efficacy with clinically meaningful weight loss, and have been considered as game-changers in the diabesity population. Emerging evidence has demonstrated that co-administration of glucose-dependent insulinotropic peptide (GIP) and GLP-1 results in enhanced insulinotropic effect in an additive way with significant glucagonostatic response, compared with the administration of each hormone separately. These findings have driven the choice to pursue incretin-based dual agonist therapies, known as ‘twincretin’. Observations from the global registration Phase III trials suggest that tirzepatide (a novel dual GIP/GLP-1 receptor agonist) represent advancement over current GLP-1 analogues, providing enhanced glycaemic and weight benefits with similar gastrointestinal tolerability. However, data are limited from patients with a range of ethnicities, and several questions remain unanswered.

IBE-Signal: Reshaping Signal into a MITM-Attack-Resistant Protocol

The Signal Protocol is one of the most popular privacy protocols today for protecting Internet chats and supports end-to-end encryption. Nevertheless, despite its many advantages, the Signal Protocol is not resistant to Man-In-The-Middle (MITM) attacks because a malicious server can distribute the forged identity-based public keys during the user registration phase. To address this problem, we proposed the IBE-Signal scheme that replaced the Extended Triple Diffie–Hellman (X3DH) key agreement protocol with enhanced Identity-Based Encryption (IBE). Specifically, the adoption of verifiable parameter initialization ensures the authenticity of system parameters. At the same time, the Identity-Based Signature (IBS) enables our scheme to support mutual authentication. Moreover, we proposed a distributed key generation mechanism that served as a risk decentralization to mitigate IBE’s key escrow problem. Besides, the proposed revocable IBE scheme is used for the revocation problem. Notably, the IND-ID-CPA security of the IBE-Signal scheme is proven under the random oracle model. Compared with the existing schemes, our scheme provided new security features of mutual authentication, perfect forward secrecy, post-compromise security, and key revocation. Experiments showed that the computational overhead is lower than that of other schemes when the Cloud Privacy Centers (CPCs) number is less than 8.

Adagrasib in Non–Small-Cell Lung Cancer Harboring a KRASG12C Mutation

BackgroundAdagrasib, a KRASG12C inhibitor, irreversibly and selectively binds KRASG12C, locking it in its inactive state. Adagrasib showed clinical activity and had an acceptable adverse-event profile in the phase 1–1b part of the KRYSTAL-1 phase 1–2 study.MethodsIn a registrational phase 2 cohort, we evaluated adagrasib (600 mg orally twice daily) in patients with KRASG12C-mutated non–small-cell lung cancer (NSCLC) previously treated with platinum-based chemotherapy and anti–programmed death 1 or programmed death ligand 1 therapy. The primary end point was objective response assessed by blinded independent central review. Secondary end points included the duration of response, progression-free survival, overall survival, and safety.ResultsAs of October 15, 2021, a total of 116 patients with KRASG12C-mutated NSCLC had been treated (median follow-up, 12.9 months); 98.3% had previously received both chemotherapy and immunotherapy. Of 112 patients with measurable disease at baseline, 48 (42.9%) had a confirmed objective response. The median duration of response was 8.5 months (95% confidence interval [CI], 6.2 to 13.8), and the median progression-free survival was 6.5 months (95% CI, 4.7 to 8.4). As of January 15, 2022 (median follow-up, 15.6 months), the median overall survival was 12.6 months (95% CI, 9.2 to 19.2). Among 33 patients with previously treated, stable central nervous system metastases, the intracranial confirmed objective response rate was 33.3% (95% CI, 18.0 to 51.8). Treatment-related adverse events occurred in 97.4% of the patients — grade 1 or 2 in 52.6% and grade 3 or higher in 44.8% (including two grade 5 events) — and resulted in drug discontinuation in 6.9% of patients.ConclusionsIn patients with previously treated KRASG12C-mutated NSCLC, adagrasib showed clinical efficacy without new safety signals. (Funded by Mirati Therapeutics; ClinicalTrials.gov number, NCT03785249.)

Augmented Reality in Surgery: A Scoping Review

Augmented reality (AR) is an innovative system that enhances the real world by superimposing virtual objects on reality. The aim of this study was to analyze the application of AR in medicine and which of its technical solutions are the most used. We carried out a scoping review of the articles published between 2019 and February 2022. The initial search yielded a total of 2649 articles. After applying filters, removing duplicates and screening, we included 34 articles in our analysis. The analysis of the articles highlighted that AR has been traditionally and mainly used in orthopedics in addition to maxillofacial surgery and oncology. Regarding the display application in AR, the Microsoft HoloLens Optical Viewer is the most used method. Moreover, for the tracking and registration phases, the marker-based method with a rigid registration remains the most used system. Overall, the results of this study suggested that AR is an innovative technology with numerous advantages, finding applications in several new surgery domains. Considering the available data, it is not possible to clearly identify all the fields of application and the best technologies regarding AR.

Learning curve for robotic assisted total knee arthroplasty: our experience with imageless hand-held Navio system.

The main purpose of this study was to determine the learning curve of Robotic assisted Total Knee Arthroplasty surgery through assessment of operative time and comparison with that of conventional jig based Total Knee Arthroplasty. The study included our first 75 Robotic assisted Total Knee Arthroplasty and 25 randomly selected conventional jig-based Total knee arthroplasty from June 2017 to December 2017. The 75 cases were divided into 3 groups of 25 consecutive cases. The mean of operative time for each phase and total time was compared between the 3 groups and with the mean of total time for conventional jig based group. In our experience, Robotic assisted Total Knee arthroplasty was associated with a learning curve of approximately 25 cases. The mean for Registration phase of Group A (1st set of 25 cases) was 6.12min (SD 1.8min), group B (2nd set of 25 cases) was 4.46min (SD 0.79min) and group C (3rd set of 25 cases) was 4.17min (SD 0.59min). The mean for Planning phase of group A was 5.08min (SD 1.01min), group B was 4.04min (SD 0.37min) and group C was 4.01min (SD 0.35min). The mean for Cutting Phase of group A was 28.22min (SD 6.24min), group B was 22.49min (SD 0.79min) and group C was 22.36min (SD 0.88min). The mean for total time of group A was 39.42min (SD 8.02), group B was 31min (SD 1.22min), group C was 30.53min (SD 1.14min) and conventional group was 30.54min (SD 1.14min). On comparing the Registration phase (Group A vs B, p < 0.001; Group B vs C, p 0.14; Group A vs C, p < 0.001), Planning phase (Group A vs B, p < 0.001; Group B vs C, p 0.75; Group A vs C, p < 0.001), Cutting phase (Group A vs B, p < 0.001; Group B vs C, p 0.58; Group A vs C, p < 0.001) and Total time (Group A vs B, p < 0.001; Group B vs C, p 0.74; Group A vs C, p < 0.001; Group A vs Conventional, p < 0.001; Group B vs Conventional, p 0.17, Group C vs Conventional, p 0.99), the results showed that the inflection point for learning curve in our hands was 25 cases. The learning curve and increased operation theatre time are likely to be major barrier in widespread acceptance of robotic technology amongst arthroplasty surgeons. We, in our experience can say that the learning curve was approximately 25 cases. The results of this study will help the arthroplasty surgeons in accepting this technology and achieve better outcomes.

Phase IB trial of pegylated arginine deiminase (ADI-PEG 20) plus radiotherapy and temozolomide in patients with newly diagnosed glioblastoma.

2057 Background: ADI-PEG 20 exploits the different metabolic ability for synthesizing arginine (Arg) between normal and neoplastic cells to reduce tumor cell growth. Preclinical and clinical studies have shown that cancers which are either Arg auxotrophic, with silencing of argininosuccinate synthetase ( ASS1), or Arg non-auxotrophic, respond to ADI-PEG 20 monotherapy or ADI-PEG 20 combined with various chemotherapies, respectively. ADI-PEG 20 has shown efficacy as monotherapy in ASS1 negative mouse glioblastoma (GBM) models and the combination of ADI-PEG 20 with temozolomide (TMZ) and with radiation (RT) in both ASS1 negative and ASS1 positive mouse GBM models. Based on these rationales, ADI-PEG 20 was added to standard RT + TMZ in patients with newly diagnosed GBM. This is the first clinical trial combining ADI-PEG 20 with RT. Methods: This phase IB, open-label, single-arm, standard 3+3 dose escalation with a recommended phase 2 dose (RP2D) expansion study (NCT04587830) was initiated in June 2020. Weekly ADI-PEG 20 is added to concurrent RT + TMZ and to 6 cycles of adjuvant TMZ (Stupp protocol). ADI-PEG 20 could be continued for up to 2 years. RANO criteria are used to determine response by evaluating MRI at 1, 3 and 6 months after RT, and every 3 months thereafter. Major eligibility criteria are age 20-75 years with newly diagnosed, histologically confirmed GBM with Karnofsky performance status ≥ 60. Endpoints include safety, pharmacodynamics, immunogenicity, progression free survival (PFS) and overall survival (OS). Results: Cohorts 1 (18 mg/m2) and 2 (36 mg/m2) were completed without dose limiting toxicity (DLT). Enrollment to cohort 3 (RP2D phase, 36 mg/m2) is ongoing with 23/26 patients. The major adverse events (AEs) were fatigue (52%), constipation (39%) and neutrophil decrease (39%). Dermatologic or allergic reactions occurred in 12/23 (52%), and all were grade 1-2 except for anaphylactic shock in 1 and vasculitis/rash in 1. 22/23 are alive, with median PFS = 9.5 months. The first 6 study patients are all alive for at least 11 months, with the longest at 1.5 years. 10 are off treatment due to progressive disease in 6, severe AE in 2, consent withdrawal in 1, and medical decision in 1. Mean peripheral blood Arg levels were suppressed ( &lt; 10uM) for 4-6 weeks in most subjects, with a reciprocal elevation of citrulline levels. Anti-ADI-PEG 20 antibodies tended to increase as peripheral Arg levels increased. Conclusions: The addition of ADI-PEG 20 to RT + TMX was safe, and no DLT was observed. The RP2D of ADI-PEG 20 was determined to be 36mg/m2. AEs were those typically seen with RT + TMZ, with perhaps an increase in rash reported with the addition of ADI-PEG 20. Anaphylaxis and vasculitis were seen (1 subject with each), and have been observed previously with ADI-PEG 20. The preliminary OS data are encouraging. A registration phase 2/3 trial of this triplet is being considered. Clinical trial information: NCT04587830.

Naxitamab (NAX) treatment for refractory/relapsed (R/R) high-risk neuroblastoma (HR-NB): Response data and efficacy in patient (pt) subgroups.

e22019 Background: Almost half of pts with NB present with high-risk disease, most of whom experience persistence of disease or disease progression. Further, residual disease in the bone/bone marrow (BM) can drive relapse. NAX is a humanized GD2-binding monoclonal antibody indicated under accelerated approval in the US with GM-CSF for the treatment of R/R HR-NB in the bone/BM in pts ≥1 year of age with a partial response (PR), minor response (MR), or stable disease (SD) to prior therapy. Here we characterize the response data of NAX overall and efficacy in pt subgroups. Methods: Trial 201 is an ongoing registrational phase II trial evaluating NAX in pts with R/R HR-NB. Pts with progressive or residual soft tissue disease were excluded. NAX was administered over 30-60 min in the outpatient setting on Days 1/3/5 at 3 mg/kg/day with GM-CSF at 250 µg/m2/day on Days –4 to 0 and 500 µg/m2/day on Days 1 to 5; cycles were every 4 wks. Efficacy was evaluated by independent pathology and radiology review per revised International Neuroblastoma Response Criteria. Results: Results presented here are from an ad hoc interim analysis (Aug 5, 2020) of 48 pts (safety population) and 36 (efficacy population). Pts in the efficacy population received a median of 7 cycles (range 1–11). Overall response rate (ORR; complete response [CR] + PR) was 58% (44% CR; Table). Of the 9 responders who had PR initially, 4 improved to CR. Median number of cycles before onset of response (CR or PR) was 2 (range 2–8) and median time to onset of response (CR or PR) was 7.3 wks (95% CI 6–17). Median duration of response was 24.9 wks (95% CI 25–not estimable). The most common adverse events (CTCAE graded) were infusion-related reactions including hypotension and pain, which occurred in 98% and 96% of pts, respectively. Adverse events were managed with established guidelines. Conclusions: NAX provided a clinically meaningful response in pts with R/R HR-NB limited to bone/BM – frequent sites of residual disease. Response rates were generally consistent across subgroups. These efficacy results combined with a manageable safety profile and use in the outpatient setting demonstrate that NAX addresses a significant unmet medical need. Clinical trial information: NCT03363373. [Table: see text]

An efficient multilevel security architecture for blockchain-based IoT networks using principles of cellular automata.

The tremendous increase in the use of Internet of Things (IoT) has made an impact worldwide by changing the mode of day-to-day life. Like any other application, IoT based networks also have to be protected since the data produced consist of sensitive information. Existing algorithms for providing security in such networks do not consider all the security objectives. Starting from the sensing of data from IoT environment, the data have to be protected from several types of attacks. Also, the authentication of involved entities, integrity of data, access control and confidentiality are to be achieved. This work proposes a novel security architecture for IoT based distributed applications. The architecture uses the best known lightweight cipher ChaCha20. Principles of cellular automata are applied for random number generation to attain more security and randomness. Double encryption ensures multilevel protection of data during the data uploading and storing phases. Providing encryption based on dynamic session keys guarantees the security of the method. It also ensures secure data sharing, mutual authentication between communicating entities, fast execution, user authentication and message integrity. The IoT device connected to a gateway node has to complete registration phase successfully. Subsequently, each time a data transfer between the device and gateway node takes place, mutual authentication phase is executed. Blockchain network used at the edge level ensures authentication of participating nodes and hence, unintended modification of data is prevented. The proposed architecture proves to be efficient in terms of throughput, execution time and resistance to various security attacks.

Development of a Mobile-Healthcare Application for Safety and Prevention in Emergency Assistance at Marathon Events: A Case Study in CMU Marathon

The majority of marathon deaths are caused by sudden cardia arrest which occurs in approximately 1 in 100,000 runners around the world. In such cases, sudden resuscitation of first aid, including an early use of automated external defibrillator (AED) on runners by medical staff is immediately necessary. However, in some cases patient information of the runner is required to support the clinical decision-making of the medical staff, including the admission to hospital with certain symptoms. To make marathon events safer, we developed a mobile-healthcare emergency assistance application for safety and prevention in marathon events. Our project covers three phases: registration, data analytics and running phases. In the registration phase, we designed and developed a form containing the runner’s electronic personal health record filled in during the registration of the runner at the event. For the analytics and running phases, we analyze the data from the registration phase in order to prepare the capacity of resource and medical staff necessary to prevent and treat injuries and accidents including a sufficient number of AED devices. Finally, for the running phase, we developed a mobile application Medic and Track based on the qr code scanning in BIB for patient information that allows to locate the runner's emergency aid point and bring the patient to that rescue point or hospital. We also tested the application on a large number of runners participating in the CMU marathon 2020 with 9721 runners. The results of this study suggest that the purpose of our application can be generally accepted for the medical staff, and it also proved to be a suitable technology to prevent serious accidents in future marathon events.

A Hybrid Graphical Password Technique for Mobile Data Security Based on Direction

Mobile Security has exponentially increased data sensitivitydue to the users upsurge in mobile devices. People are utilizing smartphones as the substitute for desktop or laptop systems, from which they access, download, upload, modify, create, and share their files. Every data has become crucial as and when exposed to other platforms via smartphone. Therefore, all smartphones require security from malicious users. Forthcoming mobile devices will have hybrid graphical passwords as prospects for customer authentication. Users can easily interact with their devices through mixed authentication techniques on mobiles by safely entering the graphical passwords. This paper focuses on Character Set and Direction (CSD) technique developed on the android application for mobiles, which takes a character set and a unique direction as a graphical password for its input method. The significant advantage of the proposed technique is that; it is user-friendly, lightweight, has an extraordinary input/output modality, and has a custom-built mobile application prototype for the Registration and Login Phase. Developed a mobile application for Character set and Direction with four standard directions to construct a unique password scheme and investigate its security, memorability, and graphical user interface. The results are highly encouraging as this technique can be a highly secured authentication technique and high user memorability, and increased usability.

A blockchain-based lightweight identity authentication scheme for the IEDs of security and stability control system

As an important part of the second defense line of the power system, the Security and Stability Control System (SSCS) is of great significance to ensure the reliable operation of the power system. However, SSCS still lacks an effective security mechanism and is easily accessed by attackers, thus posing a threat to the stable and reliable operation of the power system. To tackle this issue, we propose a blockchain-based identity authentication scheme for Intelligent Electronic Devices (IEDs) of SSCS. We first propose an identity authentication system model for IEDs and design the deployment of consortium chain nodes on IEDs, with architectural characteristics of SSCS and the working scenario of IEDs taken into consideration. The consortium chain is used to store credentials required for authentication, ensuring that they are tamper-proof. We combine IP address, port number and physical ID, and propose the unique identification of IEDs, with a data structure designed for the identification. We also propose a lightweight identity authentication method based on renewable hash chains, with hash chains used as one-time authentication passwords, and introduce a renewal mechanism of hash chains. Further, the detailed processes of registration and authentication phase are designed. Finally, the security analysis shows that our identity authentication scheme can resist various attacks, and the feasibility of our scheme is verified by experiments.

Improvement in parasympathetic regulation is associated with engagement in classroom activity in primary school children experiencing poor classroom climate.

Self-regulation promotes engagement within the classroom. At a physiological level, a good indicator of the ability of the system to self-regulate is cardiac vagal tone (CVT). The present study aims to assess children's change over time (1year) in their parasympathetic regulation (by way of CVT) in response to a social and cognitive stressor. Moreover, it addresses whether, if present, this change over time in regulation influences students' engagement in classroom activities while also accounting for classroom climate. Forty-nine second graders were assessed at two time points: November 2018 (T1) and 1year later in 2019 (T2). Children's CVT was registered at rest and while performing a stressful task during which they were asked to cognitively perform while being socially evaluated. Children were also interviewed on how much they feel engaged in classroom activities and their perceptions of classroom climate. A repeated measures analysis of variance including 2Time Points ×2 Phases of CVT Registration (baseline and during the stressful task) revealed a significant decrease in cardiac vagal activity from baseline to the task at T1, indicating that initially most children were not able to self-regulate and gave way to a stress response when facing the stressful task. The pattern changed at T2 when an active regulation took place signalled by an increase in CVT from baseline to the stressful task. Data analysis also revealed that among children who perceived a poorer classroom climate, the display of greater parasympathetic regulation over time was linked with higher active engagement in classroom activities. Growth in physiological regulation in response to a challenging task is associated with better engagement in classroom activities. Interventions and educational practice promoting the development of self-regulation strategies are recommended.