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At least 1,171 records · Page 65

NASA and NSBRI's Kelly Twins Study: Progress Implementing the First Integrated Omics Pilot Demonstration Study in Space

This opportunity has emerged from NASA's decision to fly veteran NASA astronaut Scott Kelly aboard the International Space Station (ISS) for a period of one year commencing in March 2015, while his identical twin brother, retired NASA astronaut Mark Kelly, remains on Earth. Scott Kelly, a veteran of two Space Shuttle flights as well as a six-month ISS mission, will have a cumulative duration of 540 days in low Earth orbit at the conclusion of the one-year flight, while Mark Kelly, a veteran of four Space Shuttle flights, has a cumulative duration of 54 days ( 2 hours and 4 minutes) in low Earth orbit. This opportunity originated at the initiative of the twin astronauts themselves

Scott, Graham B. I.↗

Lunar Flight Study Series: Volume 8. Earth-Moon Transit Studies Based on Ephemeris Data and Using Best Available Computer Program. Part 3: Analysis of Some Lunar Landing Site Problems Utilizing Two Fundamental Principles

This report presents two fundamental properties of lunar trajectories and makes use of these properties to solve various lunar landing site problems. Not only are various problems treated and solved but the properties and methods are established for use in the solution of other problems. This report presents an analysis of lunar landing site problems utilizing the direct mission mode as well as the orbital mission mode. A particular landing site is then specified and different flight profiles are analyzed for getting an exploration vehicle to that landing site. Rendezvous compatible lunar orbits for various stay-times at the landing site are treated. Launch opportunities are discussed for establishing rendezvous compatible lunar orbits without powered plane changes. Then, the minimum required plane changes for rendezvous in the lunar orbit are discussed for launching from earth on any day. On days that afford rendezvous compatible opportunities, there are no powered plane change requirements in the operations from launch at AMR through the rendezvous in lunar orbit, after the stay at the lunar site.

Tucker, W. B.↗

Advanced Clothing Studies

All human space missions require significant logistical mass and volume that add an unprecedented burden on longduration missions beyond low-Earth orbit. For these missions with limited cleaning resources, a new wardrobe must be developed to reduce this logistical burden by reducing clothing mass and extending clothing wear. The present studies have been undertaken, for the first time, to measure length of wear and to assess the acceptance of such extended wear. Garments in these studies are commercially available exercise T-shirts and shorts, routine-wear T-shirts, and longsleeved pullover shirts. Fabric composition (cotton, polyester, light-weight, superfine Merino wool, modacrylic, cotton/rayon, polyester/Cocona, modacrylic/Xstatic, modacrylic/rayon, modacrylic/lyocell/aramid), construction (open knit, tight knit, open weave, tight weave), and finishing treatment (none, quaternary ammonium salt) are the independent variables. Eleven studies are reported here: five studies of exercise T-shirts, three of exercise shorts, two of routine wear Tshirts, and one of shirts used as sleep-wear. All studies are conducted in a climate-controlled environment, similar to a space vehicle's. For exercise clothing, study participants wear the garments during aerobic exercise. For routine wear clothing, study participants wear the T-shirts daily in an office or laboratory. Daily questionnaires collected data on ordinal preferences of nine sensory elements and on reason for retiring a used garment. Study 1 compares knitted cotton, polyester, and Merino exercise T-shirts (61 participants), study 2, knitted polyester, modacrylic, and polyester/Cocona exercise T-shirts (40 participants), study 3, cotton and polyester exercise shorts, knitted and woven (70 participants), all three using factorial experimental designs with and without a finishing treatment, conducted at the Johnson Space Center, sharing study participants. Study 4 compares knitted polyester and ZQ Merino exercise T-shirts, study 5, knitted ZQ Merino and modacrylic routine-wear T-shirts, with study 6 using only knitted polyester exercise shorts. No finishing treatment is used. Studies 4 and 5 use cross-over experimental designs, and all three studies were conducted aboard the ISS with six crew. Studies 4 and 6 were repeated on the ground with the same participants to learn if perception was affected microgravity. Study 7 is a longer-term, single-blind panel study of knitted routine-wear undershirts with at least 12 participants to assess tolerance to Merino by comparing it with a cotton/rayon blends, using a cross-over design, eliminating carryover effects with wash-out periods between shirts.

Orndoff, Evelyne↗

A Review of Value of Solar Studies In Theory and In Practice

This brief summarizes a collection of state- and utility-commissioned value-of-solar (VoS) studies and related literature, with a focus on who commissioned the study, which value and cost categories were discussed and/or quantified, and the methods used. Our objective is to compile information on prior VoS studies to inform state regulators and other stakeholders that may pursue related studies or integrate findings into rate design. The brief is organized into three parts: 1) an introduction to distributed solar photovoltaic (DPV) compensation; 2) a review of theoretical research on VoS; and 3) a review of VoS studies. The vast majority of VoS studies have served an informational role of quantifying the net benefits of PV. Three studies were commissioned in states or utility service territories that subsequently implemented VoS tariffs in California, New York, and Austin, Texas. When applied as a tariff, VoS aims to compensate PV output as efficiently as possible by doing so at rates that reflect the marginal benefits and costs of PV through value and cost categories that may vary temporally and/or geographically. This could lead to higher compensation in locations and times where more PV output is more valuable and consequently drive adoption in those locations to provide more societal benefits. Value and cost factors can be broadly grouped into five categories: generation, transmission, distribution, other utility, and other social categories. Those conducting VoS studies must weigh various tradeoffs when deciding which categories to include and quantify. Tradeoffs include prioritizing values based on their magnitude of value or cost impact, as well as taking into account the feasibility of data collection and accurate quantification. Values of higher magnitude and estimation feasibility are quantified in the majority of studies, including the earliest of studies conducted in the 2000s and 2010s. Additionally, some values of higher magnitude but low feasibility in the earliest of studies have become quantifiable in recent years. There are some values with low average system-wide levels but very high magnitude in specific locations or hours. The value magnitude in some cases can be tied to DPV penetration with low value in areas with little congestion and/or low penetration and vice versa. In these cases, values that are easier to quantify are often incorporated, while those that are more difficult are often addressed via a placeholder value. The placeholder value is paired with a discussion around data needs and methods to improve future estimates, as well as a conversation about when these value categories may increase in magnitude and necessitate more rigorous quantification. This brief summarizes findings from two meta-analyses of VoS studies that took place between 2005 and 2018, as well as findings from four additional studies published from 2018 to 2023. Table ES-1 summarizes the various value and cost categories included in each respective study and whether they were quantified, discussed, or omitted. Values such as avoided energy, capacity, transmission capacity, line losses, and avoided environmental costs are quantified in every study. Some categories were deemed harder to quantify and less impactful at the time of the study, so they were discussed but not quantified (e.g., ancillary services). Other categories, including many at the distribution level, were very locationally and/or temporally specific and dependent on high DPV penetration. These were sometimes quantified and at other times discussed. Notably, when it came to utility costs, integration costs were discussed in all cases, though they were deemed to have a small impact. Other utility costs were omitted for the most part; however, the utility-commissioned study (by NorthWestern Energy in Montana) included both lost utility revenue and programmatic/administrative cost categories. While there are some similarities across studies, each had fairly unique methods that are detailed in the body of this brief.

14 SOLAR ENERGY↗

Advanced Exploration Systems (AES) Logistics Reduction and Repurposing Project: Advanced Clothing Ground Study Final Report

All human space missions require significant logistical mass and volume that will become an excessive burden for long duration missions beyond low Earth orbit. The goal of the Advanced Exploration Systems (AES) Logistics Reduction & Repurposing (LRR) project is to bring new ideas and technologies that will enable human presence in farther regions of space. The LRR project has five tasks: 1) Advanced Clothing System (ACS) to reduce clothing mass and volume, 2) Logistics to Living (L2L) to repurpose existing cargo, 3) Heat Melt Compactor (HMC) to reprocess materials in space, 4) Trash to Gas (TTG) to extract useful gases from trash, and 5) Systems Engineering and Integration (SE&I) to integrate these logistical components. The current International Space Station (ISS) crew wardrobe has already evolved not only to reduce some of the logistical burden but also to address crew preference. The ACS task is to find ways to further reduce this logistical burden while examining human response to different types of clothes. The ACS task has been broken into a series of studies on length of wear of various garments: 1) three small studies conducted through other NASA projects (MMSEV, DSH, HI-SEAS) focusing on length of wear of garments treated with an antimicrobial finish; 2) a ground study, which is the subject of this report, addressing both length of wear and subject perception of various types of garments worn during aerobic exercise; and 3) an ISS study replicating the ground study, and including every day clothing to collect information on perception in reduced gravity in which humans experience physiological changes. The goal of the ground study is first to measure how long people can wear the same exercise garment, depending on the type of fabric and the presence of antimicrobial treatment, and second to learn why. Human factors considerations included in the study consist of the Institutional Review Board approval, test protocol and participants' training, and a web-based data collection questionnaire. Cardiovascular exercise was chosen as the activity in this experiment for its profuse sweating effect and because it is considered a more severe treatment applied to the clothes than every-day usage. Study garments were exercise T-shirts and shorts purchased from various vendors. Fabric construction, fabric composition, and finishing treatment were defined as the key variables. The study was divided into three balanced experiments: a cotton-polyester-wool (CPW) T-shirts study with 61 participants, a polyester-modacrylic-polyester/cocona (PMC) T-shirts study with 40 participants, and a shorts study with 70 participants. In the CPW study, the T-shirts were made of 100% cotton, or of 100% polyester or of 100% wool, and categorized into open and tight knit constructions. In the PMC study, the T-shirts were made of 100% polyester, or of 82% modacrylic, or of 95% polyester with 5% cocona fiber, without construction distinction. The shorts were made either of 100% cotton or of 100% polyester, and were knitted or woven. Some garments were treated with Bio-Protect 500 antimicrobial finish according to the experimental design. The data collected from the questionnaire included garment identification, level of exertion, duration of exercise session, number of exercise sessions, an ordinal preference scale for nine sensory elements, and reason for retiring a used garment. From the analysis of the combined CPW and PMC shirt studies, there are statistically significant differences among the mean lifetimes of various types of shirts. The exercise shirts with the longest mean lifetimes are untreated wool (600 minutes), treated cotton (526 minutes), and untreated modacrylic (515 minutes). From the combined CPW and PMC shirt studies, the most preferred material was untreated open-knit wool, which is one of the two materials that jointly were worn the longest, untreated wool, both open-knit and tight-knit. For the CP shorts study, there were no statistically significant differences in mean lifetimes of the exercise shorts at the 5% significance level due to the treatment combinations. There was therefore no justification to examine differences among levels of main effects or interactions. The preference for shorts was in this order: untreated woven polyester, untreated knitted polyester, untreated woven cotton, and treated knitted cotton. The nine preference scales were tabulated to determine the preference responses at the end of those exercise periods which were prior to the period when a garment was retired and a new garment was started. The assumption is that an unfavorable assessment of a garment leads to its retirement. The scent scale response was predominantly unfavorable at the end of the exercise period immediately prior to the exercise period when a new garment was started.

Byrne, Vicky↗

Dose-finding studies in drug development for rare genetic diseases

The small patient populations inherent to rare genetic diseases present many challenges to the traditional drug development paradigm. One major challenge is generating sufficient data in early phase studies to inform dose selection for later phase studies and dose optimization for clinical use of the drug. However, optimizing the benefit-risk profile of drugs through appropriate dose selection during drug development is critical for all drugs, including those being developed to treat rare diseases. Recognizing the challenges of conducting dose finding studies in rare disease populations and the importance of dose selection and optimization for successful drug development, we assessed the dose-finding studies and analyses conducted for drugs recently approved for rare genetic diseases. Of the 40 marketing applications for new molecular entity (NME) drugs and biologics approved by the United States Food and Drug Administration for rare genetic diseases from 2015 to 2020, 21 (53%) of the development programs conducted at least one dedicated dose-finding study. In addition, the majority of drug development programs conducted clinical studies in healthy subjects and included population pharmacokinetic and exposure–response analyses; some programs also conducted clinical studies in patient populations other than the disease for which the drug was initially approved. The majority of primary endpoints utilized in dedicated dose-finding studies were biomarkers, and the primary endpoint of the safety and efficacy study matched the primary endpoint used in the dose finding study in 9 of 13 (69%) drug development programs where primary study endpoints were assessed. Our study showed that NME drug development programs for rare genetic diseases utilize multiple data sources for dosing information, including studies in healthy subjects, population pharmacokinetic analyses, and exposure–response analyses. In addition, our results indicate that biomarkers play a key role in dose-finding studies for rare genetic disease drug development programs. Our findings highlight the need to develop study designs and methods to allow adequate dose-finding efforts within rare disease drug development programs that help overcome the challenges presented by low patient prevalence and other factors. Furthermore, the frequent reliance on biomarkers as endpoints for dose-finding studies underscores the importance of biomarker development in rare diseases.

60 APPLIED LIFE SCIENCES↗