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Mycoplasma species (spp.) bacteria can infect cell cultures, posing a potential threat to recipients of cell therapy products. Conventional Mycoplasma testing methods are highly sensitive but typically require a minimum of 28 days to produce results. This delay is problematic if rapid results are needed to inform treatment decisions. Nucleic acid amplification technique (NAT) methods have been gaining favor for Mycoplasma testing due to their speed and specificity; however, they must first be qualified as meeting or exceeding the sensitivity of the compendial method. We present herein a NAT method for the detection of Mycoplasma that circumvents the need for live Mycoplasma spp. in the test procedure by instead being qualified using Mycoplasma spp. genomic DNA. We have demonstrated a lower limit of detection that exceeds the regulatory requirements set by Health Canada. This assay is now being used to screen clinical cell therapy products manufactured at our center.

Background. Prior studies have found that residential proximity to upstream oil and gas production is associated with increased risk of adverse health outcomes. Emissions of ambient air pollutants from oil and gas wells in the preproduction and production stages have been proposed as conferring risk of adverse health effects, but the extent of air pollutant emissions and resulting nearby pollution concentrations from wells is not clear.Objectives. We examined the effects of upstream oil and gas preproduction (count of drilling sites) and production (total volume of oil and gas) activities on concentrations of five ambient air pollutants in California.Methods. We obtained data on approximately 1 million daily observations from 314 monitors in the EPA Air Quality System, 2006-2019, including daily concentrations of five routinely monitored ambient air pollutants: PM2.5, CO, NO2, O3, and VOCs. We obtained data on preproduction and production operations from Enverus and the California Geographic Energy Management Division (CalGEM) for all wells in the state. For each monitor and each day, we assessed exposure to upwind preproduction wells and total oil and gas production volume within 10 km. We used a panel regression approach in the analysis and fit adjusted fixed effects linear regression models for each pollutant, controlling for geographic, seasonal, temporal, and meteorological factors.Results. We observed higher concentrations of PM2.5 and CO at monitors within 3 km of preproduction wells, NO2 at monitors at 1-2 km, and O3 at 2-4 km from the wells. Monitors with proximity to increased production volume observed higher concentrations of PM2.5, NO2, and VOCs within 1 km and higher O3 concentrations at 1-2 km. Results were robust to sensitivity analyses.Conclusion. Adjusting for geographic, meteorological, seasonal, and time-trending factors, we observed higher concentrations of ambient air pollutants at air quality monitors in proximity to preproduction wells within 4 km and producing wells within 2 km.

This study aims to describe the demographic profile in terms of age, marital status, annual family income, and educational attainment; to describe the physical, psychological, and social manifestations; to determine and describe coping mechanisms; to determine the goals, aspirations, and needs; and to determine the interaction and impact of the lived experiences on the quality of life of X-linked dystonia-parkinsonism (XDP) patients.This qualitative-phenomenological study was conducted in the island of Panay. Purposive sampling was utilized. The researchers utilized in-depth interviews, observation, and triangulation as part of the data collection methods. The data were transcribed verbatim, kept for content analysis, and coded in their appropriate cell categories after themes were identified.Ten male patients who were residents of Panay and aged 30-65 years old participated in this study. Disease manifestations included limb dystonia, blepharospasm, truncal torsion, oromandibular symptoms, torticollis, and dysphonia, contributing to limitations in performing activities of daily living. Denial was the most common initial reaction after being diagnosed with XDP. Social manifestations were greatly affected by family and community. Money and medications were the primary needs identified by the patients with hopes of a better future for their families. There was an overall deterioration in the quality of life of the patients.XDP greatly affected the physical, psychological, and social aspects of the patients. Coping with the disease and its effects has been thought to play an important role in the perception of one's quality of life.

BACKGROUND Prolonged sitting is an independent risk behavior for the development of chronic disease. With most interventions focusing on physical activity and exercise, there is a separate need for investigation into innovative and accessible interventions to decrease sedentary behavior throughout the day. Twitter is a social media platform with application for health communications and fostering of social support for health behavior change. OBJECTIVE This pilot study aims to test the feasibility, acceptability, and preliminary efficacy of delivering daily behavior change strategies within private Twitter groups to foster peer-to-peer support and decrease sedentary behavior throughout the day in women. The Twitter group was combined with a Fitbit for self-monitoring activity and compared to a Fitbit-only control group. METHODS In a 2-group design, participants were randomized to a Twitter + Fitbit treatment group or a Fitbit-only control group. Participants were recruited via the Stanford Research Repository System, screened for eligibility, and then invited to an orientation session. After providing informed consent, they were randomized. All participants received 13 weeks of tailored weekly step goals and a Fitbit. The treatment group participants, placed in a private Twitter support group, received daily automated behavior change “tweets” informed by theory and regular automated encouragement via text to communicate with the group. Fitbit data were collected daily throughout the treatment and follow-up period. Web-based surveys and accelerometer data were collected at baseline, treatment end (13 weeks), and at 8.5 weeks after the treatment. RESULTS The initial study design funding was obtained from the Women’s Heart Clinic and the Stanford Clayman Institute. Funding to run this pilot study was received from the National Institutes of Health’s National Heart, Lung, and Blood Institute under Award Number K01HL136702. All procedures were approved by Stanford University’s Institutional Review Board, #32127 in 2018, prior to beginning data collection. Recruitment for this study was conducted in May 2019. Of the 858 people screened, 113 met the eligibility criteria, 68 came to an information session, and 45 consented to participate in this pilot study. One participant dropped out of the intervention, and complete follow-up data were obtained from 39 of the 45 participants (87% of the sample). Data were collected over 6 months from June to December 2019. Feasibility, acceptability, and preliminary efficacy results are being analyzed and will be reported in the winter of 2021. CONCLUSIONS This pilot study is assessing the feasibility, acceptability, and preliminary efficacy of delivering behavior change strategies in a Twitter social support group to decrease sedentary behavior in women. These findings will inform a larger evaluation. With an accessible, tailorable, and flexible platform, Twitter-delivered interventions offer potential for many treatment variations and titrations, thereby testing the effects of different behavior change strategies, peer-group makeups, and health behaviors of interest. CLINICALTRIAL ClinicalTrials.gov NCT02958189, https://clinicaltrials.gov/ct2/show/NCT02958189 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/20926

Mycoplasma species (spp.) bacteria can infect cell cultures, posing a potential threat to recipients of cell therapy products. Conventional Mycoplasma testing methods are highly sensitive but typically require a minimum of 28 days to produce results. This delay is problematic if rapid results are needed to inform treatment decisions. Nucleic acid amplification technique (NAT) methods have been gaining favor for Mycoplasma testing due to their speed and specificity; however, they must first be qualified as meeting or exceeding the sensitivity of the compendial method. We present herein a NAT method for the detection of Mycoplasma that circumvents the need for live Mycoplasma spp. in the test procedure by instead being qualified using Mycoplasma spp. genomic DNA. We have demonstrated a lower limit of detection that exceeds the regulatory requirements set by Health Canada. This assay is now being used to screen clinical cell therapy products manufactured at our center.

OBJECTIVES/SPECIFIC AIMS: Engaging patients and consumers in research is a complex process where innovative strategies are needed to effectively translate scientific discoveries into improvements in the public’s health (Wilkins et. al., 2013; Terry et. al., 2013). The Clinical Translational Science Awards (CTSA)—supported by the National Institute of Health (NIH) under the auspices of the National Center for Advancing Translational Sciences (NCATS)—aim to provide resources and support needed to strengthen our nation’s clinical and translational research (CTR) enterprise. In 2008, Stanford University was awarded a CTSA from the NIH, establishing Spectrum (Stanford Center for Clinical and Translational Research and Education) and its Community Engagement (CE) Program aimed at building long-standing community-academic research partnerships for translational research in the local area surrounding Stanford University. To date, the CE Pilot Program has funded 38 pilot projects from the 2009-2017 calendar year. The purpose of this study was to understand, through a unique pilot program, the barriers, challenges, and facilitators to community-engaged research targeting health disparities as well as community-academic partnerships. METHODS/STUDY POPULATION: Investigators conducted a qualitative study of the community engagement pilot program. Previous pilot awardees were recruited via email and phone to participate in a one-hour focus group to discuss their pilot project experience—describing any barriers, challenges, and facilitators to implementing their pilot project. RESULTS/ANTICIPATED RESULTS: The focus group revealed that community engage research through the pilot program was not only appreciated by faculty, but projects were successful, and partnerships developed were sustained after funding. Specifically, the pilot program has seen success in both traditional and capacity building metrics: the initial investment of $652,250.00 to fund 38 projects has led to over $11 million dollars in additional grant funding. In addition, pilot funding has led to peer-reviewed publications, data resources for theses and dissertations, local and national presentations/news articles, programmatic innovation, and community-level impact. Challenges and barriers were mainly related to timing, grant constraints, and university administrative processes. DISCUSSION/SIGNIFICANCE OF IMPACT: The Community Engagement Pilot Program demonstrates an innovative collaborative approach to support community-academic partnerships. This assessment highlights the value and importance of pilot program to increase community engaged research targeting health disparities. Challenges are mainly administrative in nature: pilot awardees mentioned difficulties working on university quarterly timelines, challenges of subcontracting or sharing money with community partners, onerous NIH prior approval process, and limitations to carryover funding. However, pilot grants administered through the program strengthen the capacity to develop larger scale community-based research initiatives.

OBJECTIVES/SPECIFIC AIMS: Helping researchers assess and effectively translate innovations into healthcare improvements is a complex process (Terry et. al., 2013). The Clinical Translational Science Awards (CTSA)—supported by the National Institute of Health (NIH) under the auspices of the National Center for Advancing Translational Sciences (NCATS)— provide the resources and support needed to strengthen our nation’s clinical and translational research (CTR) enterprise. In 2008, Stanford University was awarded a CTSA from the NIH, establishing Spectrum (the Stanford Center for Clinical and Translational Research and Education). Under the Spectrum umbrella, the Byers Center for Biodesign manages the MedTech Pilot Program with the goal of translating discoveries into novel health technologies that address important unmet health needs. The MedTech Pilot Program is an innovative funding mechanism that seeks to (1) stimulate clinical translational research, (2) help promising projects bridge the gap between the bench and the patients’ bedside, and (3) encourage collaborative, transdisciplinary work. Specifically, the Pilot Program offers up to $50,000 to support projects involving medical devices and mobile technologies used for (1) therapeutic applications and (2) device-based patient-specific (or POC) diagnostic applications. This analysis of the MedTech Pilot Program will: 1) describe the Program’s structure and process; 2) highlight the intensive, hands-on mentorship and practical guidance awardees receive that enables them to more efficiently and effectively advance their projects toward patient care; and 3) characterize the progress of the 36 funded projects. METHODS/STUDY POPULATION: Key elements of the Pilot Program’s infrastructure and mentoring processes as they relate to project outcomes were identified. Additionally, outcomes data were collected from two sources: (1) annual survey of Pilot Awardees and (2) publicly available information relevant to the pilot projects. RESULTS/ANTICIPATED RESULTS: The Pilot Program’s framework and infrastructure has supported a diverse group of transdisciplinary projects. These projects were evaluated using both traditional and non-traditional metrics (e.g., patents, startups, publications). The initial investment of $1.5 million to fund 36 projects has led to over $88 million dollars in additional funding. Additionally, taking full advantage of the expertise in Silicon Valley, strong mentorship has helped advance projects along the clinical and translational path. DISCUSSION/SIGNIFICANCE OF IMPACT: The Pilot Program has benefited Stanford innovators and researchers by providing seed funding to help promising projects bridge the gap between the bench and the bedside. The intensive, hands-on mentorship, early pilot funding, and practical guidance pilot awardees receive effectively help translate their technologies into patient care.

(2015). Procedural Fairness in an Information Rights Context. Judicial Review: Vol. 20, No. 1, pp. 26-32.

A SPE-LC-MS/MS method was developed and validated for the determination of three active pharmaceutical ingredients [API A (3-([2-(diaminomethyleneamino)thiazol-4-yl]methylthio)-N′-sulfamoyl propanimid amide, API B 5-[(2 R)-2-[2-(2-ethoxyphenoxy)ethylamino]propyl]-2-methoxybenzenesulfonamide hydrochloride, API C 1-azabicyclo[2.2.2]octan-8-yl (1S)-1-phenyl-3,4-dihydro-1H-isoquinoline-2-carboxylate] in the wastewater of a chemical synthesis production facility. The SPE-LC-MS/MS method was validated in actual influent and effluent samples. Linearity, LOD, LOQ, repeatability, intermediate precision, and recovery were determined. An LOQ of 400 μg · L−1, 1.0 μg · L−1, and 6 μg · L−1, repeatability of 2.5% CV, 14.8% CV, and 11.9% CV, intermediate precision of 7.8% CV, 11.0% CV, and 8.7% CV and SPE recovery of 114%, 103%, and 91% was determined for API A, B, and C, respectively, in influent. An LOQ of 400 μg · L−1, 0.8 μg · L−1, and 6 μg · L−1, repeatability of 2.0% CV, 11.0% CV, and 10.9% CV, intermediate precisi...

In recent years there has been significant growth in the use of video games technologies and game mechanics for teaching and learning. These environments and techniques offer the ability to create complex, highly interactive simulations with solid theoretical underpinnings to present teaching material in new and highly interactive ways. This paper discusses and practically demonstrates how video games mechanics can be used to create highly immersive and engaging user experiences to teach engineering related material. The Circuit Warz project is introduced and demonstrates how a game-based approach, using a competitive format, can be used to create immersive, highly engaging student but pedagogically sound learning experiences.

Legacy applications on the Mainframe platform have been, and will probably continue to be, the backbone to many large scale enterprise systems in banks and insurance companies in NA, EU and other regions across the globe. Since 1980, majority of the development, however, has been on new platforms. Predominantly, distributed systems and Web-enabled applications to support new business lines, for example, Creditor Insurance, Customer Relationship Management, and Mobile Banking, are taking the center stages. Two challenges are fundamental: how we effectively leverage the existing assets in terms of logic and data, and how we sustain the changes. The former is focusing on integration, the latter infrastructural modernization. Service Oriented Architecture (SOA) is taking hold in the industry as the preferred new way of integration and modernization. One big question remains: is SOA hype, like a fad in fashion, which will likely die out as the snow melts, or a new technological innovation alluding to financial derivatives that led to the financial market crush? Our research reveals that it is likely a hype unless a roadmap based on engineering principles is established and implemented. This paper reviews some of the failure and success factors across the industry and proposes a template to develop such a roadmap. What differentiates this paper from others is, however, a set of pressures or pain points, technical and business drivers, proven solutions and enablers (SDEP) that the authors summarized from their in-the-field and on-the-project experiences. Central to the factors is a canonical data model, which we touch on in this paper and will cover in depth in the next paper.