Characterization of mass distribution in a biomimetic aerosol exposure system.

Objective: Lack of biomimicry in geometry and flow conditions of emissions systems for analytical testing and biological exposure has led to fundamental limitations, including a poor understanding of dose delivered to specific airway locations. This work characterizes mass distribution of a JUUL® brand e-cigarette in a Biomimetic Aerosol Exposure System (BAES).

Materials And Methods: A combination of mass balance, direct measurements, and inferences based on direct measurements were used to characterize regional and local dose as a function of system flow path configuration and emissions topography profile.

Safety and immunogenicity of a single dose of Tdap compared to Td in pregnant women in Mali and 3 its effect on infant immune responses: a single-centre, randomised, double-blind, active-controlled phase 2 study.

Background: While maternal pertussis vaccination is a strategy to reduce infant morbidity, safety and immunogenicity data are limited in sub-Saharan Africa. We aimed to evaluate the safety of a single dose of tetanus, diphtheria and acellular pertussis vaccine (Tdap) vaccine compared to tetanus and diphtheria vaccine (Td) vaccine in pregnant women in Bamako, Mali and to assess the pertussis toxin (PT) antibody response at birth.

Methods: In this phase 2, single-centre, randomised, double-blind, active-controlled study, from 23 January 2019 to 10 July 2019, healthy 18-39 year old women in the second trimester of a singleton pregnancy were randomised 2:1 to receive Tdap or Td.

Feasibility of paying people who use drugs cash to distribute naloxone within their networks.

Introduction: Immediate access to naloxone is needed to prevent fatal opioid-related overdoses in the presence of fentanyl analogs saturating the opioid supply. Peer models engage impacted populations who are not accessing naloxone through standard venues, yet compensating peers who utilize syringe service programs with cash stipends to distribute naloxone within networks of people who use drugs is not well described.

Methods: As part of the HEALing Communities Study, syringe service program-based interventions were developed in Holyoke and Gloucester, MA, which paid people who use drugs ("peers") cash to distribute naloxone.

Flow Rate and Wall Shear Stress Characterization of a Biomimetic Aerosol Exposure System.

Current in vitro emissions and exposure systems lack biomimicry, use unrealistic flow conditions, produce unrealistic dose, and provide inaccurate biomechanical cues to cell cultures, limiting ability to correlate in vitro outcomes with in vivo health effects. A biomimetic in vitro system capable of puffing aerosol and clean air inhalation may empower researchers to investigate complex questions related to lung injury and disease. A biomimetic aerosol exposure system (BAES), including an electronic cigarette adapter, oral cavity module (OCM), and bifurcated exposure chamber (BEC) was designed and manufactured.

Effect of third-party components on emissions from a pod style electronic cigarette.

Electronic nicotine delivery systems (ENDS) have been associated with a dramatic increase in youth becoming addicted to nicotine following decades-long decline in cigarette smoking uptake. The United States Food and Drug Administration, Center for Tobacco Products (FDA/CTP) is responsible for regulating devices and consumable materials associated with ENDS. State and federal regulations regarding flavoring compounds in ENDS liquids (e-liquids) may be circumvented when vendors market refillable reservoirs side-by-side with noncompliant e-liquids.

Approach for Non-Intrusive Detection of the Fit of Orthopaedic Devices Based on Vibrational Data.

The soft tissues of residual limb amputees are subject to large volume fluctuations over the course of a day. Volume fluctuations in residual limbs can lead to local pressure marks, causing discomfort, pain and rejection of prostheses. Existing methods for measuring interface stress encounter several limitations.

Safety and Immunogenicity of an Andes Virus DNA Vaccine by Needle-Free Injection: A Randomized, Controlled Phase 1 Study.

Background: Andes virus (ANDV), a rodent-borne hantavirus, causes hantavirus pulmonary syndrome (HPS). The safety and immunogenicity of a novel ANDV DNA vaccine was evaluated.

Methods: Phase 1, double-blind, dose-escalation trial randomly assigned 48 healthy adults to placebo or ANDV DNA vaccine delivered via needle-free jet injection.

Safety and immunogenicity of live, attenuated intranasal Bordetella pertussis vaccine (BPZE1) in healthy adults.

Background: BPZE1 is a live, attenuated pertussis vaccine derived from B. pertussis strain Tohama I modified by genetic removal or inactivation of 3 B. pertussis toxins: pertussis toxin, dermonecrotic toxin, and tracheal cytotoxin.

A proposed cigarette emissions topography protocol reflecting smokers' natural environment use behavior.

Background: The FTC, in 2008, rescinded its 1966 guidance regarding use of the Cambridge Filter Method, noting the yields from the method are relatively poor indicators of tar, nicotine, and carbon monoxide exposure. This article proposes a set of puffing conditions for cigarette emissions testing, with the goal of developing product-specific emissions characterizations which can subsequently be used to realistically model the yield of particulate matter and constituents to the mouth of a smoker, while accounting for the actual puffing behavior of the smoker.

Methods: Synthesis of data was conducted on data collected from a prior one-week observation of 26 adult cigarette smokers, using their usual brand cigarette in each smokers' natural environment including the puff flow rate, duration, volume and time of day of each puff taken were recorded with a cigarette topography monitor.

A general pattern of trade-offs between ecosystem resistance and resilience to tropical cyclones.

Tropical cyclones drive coastal ecosystem dynamics, and their frequency, intensity, and spatial distribution are predicted to shift with climate change. Patterns of resistance and resilience were synthesized for 4138 ecosystem time series from = 26 storms occurring between 1985 and 2018 in the Northern Hemisphere to predict how coastal ecosystems will respond to future disturbance regimes. Data were grouped by ecosystems (fresh water, salt water, terrestrial, and wetland) and response categories (biogeochemistry, hydrography, mobile biota, sedentary fauna, and vascular plants).

Proposed Standard Test Protocols and Outcome Measures for Quantitative Comparison of Emissions from Electronic Nicotine Delivery Systems.

This study introduces and demonstrates a comprehensive, accurate, unbiased approach to robust quantitative comparison of electronic nicotine delivery systems (ENDS) appropriate for establishing substantial equivalence (or lack thereof) between inhaled nicotine products. The approach is demonstrated across a family of thirteen pen- and pod-style ENDS products. Methods employed consist of formulating a robust emissions surface regression model, quantifying the empirical accuracy of the model as applied to each product, evaluating relationships between product design characteristics and maximum emissions characteristics, and presenting results in formats useful to researchers, regulators, and consumers.

A large invasive consumer reduces coastal ecosystem resilience by disabling positive species interactions.

Invasive consumers can cause extensive ecological damage to native communities but effects on ecosystem resilience are less understood. Here, we use drone surveys, manipulative experiments, and mathematical models to show how feral hogs reduce resilience in southeastern US salt marshes by dismantling an essential marsh cordgrass-ribbed mussel mutualism. Mussels usually double plant growth and enhance marsh resilience to extreme drought but, when hogs invade, switch from being essential for plant survival to a liability; hogs selectively forage in mussel-rich areas leading to a 50% reduction in plant biomass and slower post-drought recovery rate.

Feral hogs control brackish marsh plant communities over time.

Feral hogs modify ecosystems by consuming native species and altering habitat structure. These invasions can generate fundamentally different post-invasion habitats when disturbance changes community structure, ecosystem function, or recovery dynamics. Here, we use multiple three-year exclusion experiments to describe how feral hogs affect hyper-productive brackish marshes over time.

Nominal Operating Envelope of Pod and Pen Style Electronic Cigarettes.

Many Electronic Nicotine Delivery Systems (ENDS) employ integrated sensors to detect user puffing behavior and activate the heating coil to initiate aerosol generation. The minimum puff flow rate and duration at which the ENDS device begins to generate aerosol are important parameters in quantifying the viable operating envelope of the device and are essential to formulating a design of experiments for comprehensive emissions characterization. An accurate and unbiased method for quantifying the flow condition operating envelope of ENDS is needed to quantify product characteristics across research laboratories.

Feasibility of Using the Hexoskin Smart Garment for Natural Environment Observation of Respiration Topography.

: Limited research has been done to measure ambulatory respiratory behavior, in particular those associated with tobacco use, in the natural environment due to a lack of monitoring techniques. Respiratory topography parameters provide useful information for modeling particle deposition in the lung and assessing exposure risk and health effects associated with tobacco use. Commercially available Wearable Respiratory Monitors (WRM), such as the Hexoskin Smart Garment, have embedded sensors that measure chest motion and may be adapted for measuring ambulatory lung volume.

Proof of Concept for the Detection of Local Pressure Marks in Prosthesis Sockets Using Structural Dynamics Measurement.

The wear comfort of a prosthesis is of great importance for amputee patients. The wear comfort can be affected by changes in the interface between the residual limb and prosthesis socket, which can be caused by time-dependent volume fluctuations of the tissue, leading to unwanted local pressure marks. The basis to ensure time-independent wear comfort of a prosthesis is to identify these changes.

Effects of Manufacturing Variation in Electronic Cigarette Coil Resistance and Initial Pod Mass on Coil Lifetime and Aerosol Generation.

This work investigated the effects of manufacturing variations, including coil resistance and initial pod mass, on coil lifetime and aerosol generation of Vuse ALTO pods. Random samples of pods were used until failure (where e-liquid was consumed, and coil resistance increased to high value indicating a coil break). Initial coil resistance, initial pod mass, and e-liquid net mass ranged between 0.

Surveillance of U.S. Corporate Filings Provides a Proactive Approach to Inform Tobacco Regulatory Research Strategy.

The popularity of electronic cigarettes in the United States and around the world has led to a startling rise in youth nicotine use. The Juul e-cigarette was introduced in the U.S.

Feasibility Assessment of Wearable Respiratory Monitors for Ambulatory Inhalation Topography.

: Natural environment inhalation topography provides useful information for toxicant exposure, risk assessment and cardiopulmonary performance. Commercially available wearable respiratory monitors (WRMs), which are currently used to measure a variety of physiological parameters such as heart rate and breathing frequency, can be leveraged to obtain inhalation topography, yet little work has been done. This paper assesses the feasibility of adapting these WRMs for measuring inhalation topography.

Method for Quantifying Variation in the Resistance of Electronic Cigarette Coils.

In electronic nicotine delivery systems (ENDS), coil resistance is an important factor in the generation of heat energy used to change e-liquid into vapor. An accurate and unbiased method for testing coil resistance is vital for understanding its effect on emissions and reporting results that are comparable across different types and brands of ENDS and measured in different laboratories. This study proposes a robust, accurate and unbiased method for measuring coil resistance.

Characterization and Validation of the Second-generation wPUM Topography Monitors.

Introduction: Little is known about the natural use behavior of new and emerging tobacco products due to the limited availability of reliable puff topography monitors suitable for ambulatory deployment. An understanding of use behavior is needed to assess the health impact of emerging tobacco products and inform realistic standardized topography profiles for emissions studies. The purpose of this study is to validate four monitors: the wPUM cigalike, vapepen, hookah, and cigarette monitors.

Rewiring coral: Anthropogenic nutrients shift diverse coral-symbiont nutrient and carbon interactions toward symbiotic algal dominance.

Improving coral reef conservation requires heightened understanding of the mechanisms by which coral cope with changing environmental conditions to maintain optimal health. We used a long-term (10 month) in situ experiment with two phylogenetically diverse scleractinians (Acropora palmata and Porites porites) to test how coral-symbiotic algal interactions changed under real-world conditions that were a priori expected to be beneficial (fish-mediated nutrients) and to be harmful, but non-lethal, for coral (fish + anthropogenic nutrients). Analyzing nine response variables of nutrient stoichiometry and stable isotopes per coral fragment, we found that nutrients from fish positively affected coral growth, and moderate doses of anthropogenic nutrients had no additional effects.

A Comparison between Cigarette Topography from a One-Week Natural Environment Study to FTC/ISO, Health Canada, and Massachusetts Department of Public Health Puff Profile Standards.

Standardized topography protocols for testing cigarette emissions include the Federal Trade Commission/International Standard Organization (FTC/ISO), the Massachusetts Department of Health (MDPH), and Health Canada (HC). Data are lacking for how well these protocols represent actual use behavior. This study aims to compare puff protocol standards to actual use topography measured in natural environments across a range of cigarette brands.

Behavior-based yield for electronic cigarette users of different strength eliquids based on natural environment topography.

The extent to which electronic cigarette users will compensate for lower nicotine eliquids has implications on the risk associated with regulating eliquid composition. This article elucidates topography as a compensatory mechanism by investigating the impact of nicotine strength on total particulate matter (TPM) and nicotine consumed per puff. Thirty-three experienced vape pen users were assigned an NJOY™ VapePen and AVAIL™ brand Tobacco Row eliquid with their usual nicotine strength (L = 6 mg/mL, M = 12 mg/mL, H = 18 mg/mL) and vaped through RITs wPUM vape pen monitor to record every puff during 1 week.