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At least 397 records · Page 22

Discordant Clinical and Microbiological Outcomes Are Associated With Late Clinical Relapse in Clinical Trials for Complicated Urinary Tract Infections

Abstract Background Current US Food and Drug Administration guidance recommends that the primary endpoint for complicated urinary tract infection clinical trials be a composite of the clinical and microbiological responses, assessed at a fixed point after therapy. Although some participants meet the criteria for clinical success, they do not meet the criteria for microbiological eradication and are classified as treatment failures. These discordant outcomes have raised questions about the utility of the microbiological endpoint. Methods We analyzed participant data from 13 phase 3 clinical trials submitted to the US Food and Drug Administration (N = 4842). Outcomes were determined at the test of cure (TOC) visit, recommended to occur at least 5 days after therapy and at the late follow-up visit, recommended to occur 21 to 28 days after randomization. Clinical and microbiological success were defined as the resolution of complicated urinary tract infection symptoms present at study entry, with no new symptoms (clinical cure), and a reduction in density of the original pathogen to <103 CFU/mL on urine culture (microbiological eradication). Results Among included participants, 70.7% were concordant successes at the TOC visit, 18.0% were discordant failures (clinical cure/microbiological persistence), and 6.7% were concordant failures (clinical failure/microbiological persistence). Discordant participants were at an increased risk for clinical failure at the late follow-up visit, and the risk of late clinical failure increased with time. Conclusions Discordant clinical and microbiological outcomes at the TOC visit were associated with an increased risk of late clinical failure. Microbiological outcomes appear to be an important component of the endpoint.

Immunology↗

Airline Transport Pilot Preferences for Predictive Information

This experiment assessed certain issues about the usefulness of predictive information: (1) the relative time criticality of failures, (2) the subjective utility of predictive information for different parameters or sensors, and (3) the preferred form and prediction time for displaying predictive information. To address these issues, three separate tasks were administered to 22 airline pilots. As shown by the data, these pilots preferred predictive information on parameters they considered vital to the safety of the flight. These parameters were related to the checklists performed first for alert messages. These pilots also preferred to know whether a parameter was changing abnormally and the time to a certain value being reached. Furthermore, they considered this information most useful during the cruise, the climb, and the descent phases of flight. Lastly, these pilots preferred the information to predict as far ahead as possible.

Trujillo, Anna C.↗

Buckling Testing of a Subscale Composite Cylinder

A subscale solid laminate composite cylinder with a 31.5-in. diameter, a 48.2-in. length, and a [23/0/-23]4S layup was designated NDL-1 and was designed to fail in buckling after a series of subcritical tests. NDL-1 was experimentally loaded in axial compression until buckling at 466.3 kips. Visual inspection of the test article after the test revealed that a shallow area of delamination occurred near the buckling initiation site. After a successful first buckling test, there was an opportunity to test NDL-1 in axial compression to failure a second time despite that the test article was not designed or analyzed for multiple buckling tests. During the second test to failure, NDL-1 reached a peak load of 390.4 kips, 16.3% lower than the first test. Buckling did not initiate in the same location during the second test to failure as the first test to failure. The second buckling event caused a large V-shaped crack that penetrated through the thickness of the barrel. Though buckling initiated at different locations, a similar radial deformation pattern was present just prior to buckling during the both tests. In the end, NDL-1 maintained a significant amount of its structural integrity and a similar prebuckling radial displacement pattern, even after the first buckling test.

Test↗

Refurbishment of a 39 foot thermal vacuum chamber

The 39' thermal vacuum chamber at Space Systems/Loral has been used to test numerous spacecraft including those of the GOES, Intelsat, Insat, Superbird, N-Star, NATO and other programs. Ten years ago, the aluminum LN2 shroud experienced serious fatigue failures in the field welded jumper tubing, effectively shutting down the chamber for vacuum testing. The problem was repaired at the time, but new failures began to reappear a few months ago and are now occurring at a rate that suggests that the shroud may again become inoperable. Consequently, Space Systems/Loral is spending in excess of $6 million to replace the shroud and the existing LN2 equipment with a new, state of the art cryogenic system. In May, 1994, a contract was awarded to remove the existing shroud and LN2 pumping system and replace it with a gravity fed shroud and distribution system. Included in the contract are eight skid mounted gaseous nitrogen pumping systems capable of controlling shroud zone temperatures between +150 C and -180 C. The project is scheduled to be completed in April 1995.

Edwards, Arthur A.↗

Prognostics for Microgrid Components

Prognostics is the science of predicting future performance and potential failures based on targeted condition monitoring. Moving away from the traditional reliability centric view, prognostics aims at detecting and quantifying the time to impending failures. This advance warning provides the opportunity to take actions that can preserve uptime, reduce cost of damage, or extend the life of the component. The talk will focus on the concepts and basics of prognostics from the viewpoint of condition-based systems health management. Differences with other techniques used in systems health management and philosophies of prognostics used in other domains will be shown. Examples relevant to micro grid systems and subsystems will be used to illustrate various types of prediction scenarios and the resources it take to set up a desired prognostic system. Specifically, the implementation results for power storage and power semiconductor components will demonstrate specific solution approaches of prognostics. The role of constituent elements of prognostics, such as model, prediction algorithms, failure threshold, run-to-failure data, requirements and specifications, and post-prognostic reasoning will be explained. A discussion on performance evaluation and performance metrics will conclude the technical discussion followed by general comments on open research problems and challenges in prognostics.

Saxena, Abhinav↗

Managing Risk to Ensure a Successful Cassini/Huygens Saturn Orbit Insertion (SOI)

I. Design: a) S/C designed to be largely single fault tolerant; b) Operate in flight demonstrated envelope, with margin; and c) Strict compliance with requirements & flight rules. II. Test: a) Baseline, fault & stress testing using flight system testbeds (H/W & S/W); b) In-flight checkout & demos to remove first time events. III. Failure Analysis: a) Critical event driven fault tree analysis; b) Risk mitigation & development of contingencies. IV) Residual Risks: a) Accepted pre-launch waivers to Single Point Failures; b) Unavoidable risks (e.g. natural disaster). V) Mission Assurance: a) Strict process for characterization of variances (ISAs, PFRs & Waivers; b) Full time Mission Assurance Manager reports to Program Manager: 1) Independent assessment of compliance with institutional standards; 2) Oversight & risk assessment of ISAs, PFRs & Waivers etc.; and 3) Risk Management Process facilitator.

risk managment↗

Solder Joint Health Monitoring Testbed System

The density and pin count for Field Programmable Gate Arrays (FPGAs) has been increasing, and has exceeded current methods of solder joint inspection, making early detection of failures more problematic. These failures are a concern for both flight safety and maintenance in commercial aviation. Ridgetop Group, Inc. has developed a method for detecting solder joint failures in real time. The NASA Dryden Flight Research Center is developing a set of boards to test this method in ground environmental and accelerated testing as well as flight test on a Dryden F-15 or F-18 research aircraft. In addition to detecting intermittent and total solder joint failures, environmental data on the boards, such as temperature and vibration, will be collected and time-correlated to aircraft state data. This paper details the technical approach involved in the detection process, and describes the design process and products to date for Dryden s FPGA failure detection boards.

Delaney, Michael M.↗

Screening and Qualification of BME Feedthrough Capacitors for a Space Project

Surface mount technology feedthrough ceramic capacitors are gaining popularity in Hi-Rel systems due to small size and great filtering characteristics. In this work, BME feedthrough capacitors compliant with AEC-Q200 requirements have been evaluated, screened and qualified for a space project. Evaluation included analysis of the effect of post-soldering thermal shocks, temperature dependencies of leakage currents, distribution of breakdown voltages, assessments of high-current capability, and thermal resistance of the parts. The parts have been screened and qualified at conditions close to the military requirements for ceramic capacitors. No failures were detected during screening including burning-in, but two samples failed during monitored 2000 hour life testing at 125C and two times rated voltage. Failure analysis revealed manufacturing defects that required additional analysis of screening and qualification test conditions. Highly accelerated life testing (HALT) has been carried out to assess reliability acceleration factors and the probability of failure at the use conditions. An approach to selection of adequate burning-in and life test conditions is discussed.

Alexander Teverovsky↗

Screening and Qualification of BME Feedthrough Capacitors for a Space Project

Surface mount technology feedthrough ceramic capacitors are gaining popularity in Hi-Rel systems due to small size and great filtering characteristics. In this work, BME feedthrough capacitors compliant with AEC-Q200 requirements have been evaluated, screened and qualified for a space project. Evaluation included analysis of the effect of post-soldering thermal shocks, temperature dependencies of leakage currents, distribution of breakdown voltages, assessments of high-current capability, and thermal resistance of the parts. The parts have been screened and qualified at conditions close to the military requirements for ceramic capacitors. No failures were detected during screening including burning-in, but two samples failed during monitored 2000 hour life testing at 125C and two times rated voltage. Failure analysis revealed manufacturing defects that required additional analysis of screening and qualification test conditions. Highly accelerated life testing (HALT) has been carried out to assess reliability acceleration factors and the probability of failure at the use conditions. An approach to selection of adequate burning-in and life test conditions is discussed.

Alexander Teverovsky↗

A Review of the Mechanical Properties of Materials Used in Nb 3 Sn Magnets for Particle Accelerators

Superconducting magnets experience significant thermo-mechanical loads throughout their life cycle. These are introduced by the electro-magnetic forces during powering, but also by the prestress applied in many magnet designs. Further to this, the large thermal excursion that components of different materials experience can generate significant internal forces. The loads are also experienced by the superconducting coils, whose critical current can decrease as a consequence of the applied strain. It is then crucial to predict the overall mechanical behavior and conservatively design a magnet, avoiding failure of the mechanical components and of the superconducting coils. Finite Element Analysis (FEA) is generally used to perform these tasks, but its results rely heavily on the material properties and models used. This is in particular true for the coil composite, which is simplified to allow reasonable model sizes in full magnet models. Here we present the state-of-art knowledge of the mechanical properties of the materials mostly used in superconducting magnet construction. We review elastic and plastic properties at room and cryogenic temperature, thermal contraction, and summarize the state-of-art failure criteria for these materials. Finally, the paper summarizes the present understanding of the mechanical behavior and limits of Nb3Sn coils. For the first time, an orthotropic failure criteria is proposed.

75 CONDENSED MATTER PHYSICS, SUPERCONDUCTIVITY AND↗

Reliable dual-redundant sensor failure detection and identification for the NASA F-8 DFBW aircraft

A technique was developed which provides reliable failure detection and identification (FDI) for a dual redundant subset of the flight control sensors onboard the NASA F-8 digital fly by wire (DFBW) aircraft. The technique was successfully applied to simulated sensor failures on the real time F-8 digital simulator and to sensor failures injected on telemetry data from a test flight of the F-8 DFBW aircraft. For failure identification the technique utilized the analytic redundancy which exists as functional and kinematic relationships among the various quantities being measured by the different control sensor types. The technique can be used not only in a dual redundant sensor system, but also in a more highly redundant system after FDI by conventional voting techniques reduced to two the number of unfailed sensors of a particular type. In addition the technique can be easily extended to the case in which only one sensor of a particular type is available.

Deckert, J. C.↗

James Webb Space Telescope (JWST) Integrated Science Instruments Module (ISIM) Electronics Compartment (IEC) Conformal Shields Composite Bond Structure Qualification Test Method

The JWST IEC conformal shields are mounted onto a composite frame structure that must undergo qualification testing to satisfy mission assurance requirements. The composite frame segments are bonded together at the joints using epoxy, EA 9394. The development of a test method to verify the integrity of the bonded structure at its operating environment introduces challenges in terms of requirements definition and the attainment of success criteria. Even though protoflight thermal requirements were not achieved, the first attempt in exposing the structure to cryogenic operating conditions in a thermal vacuum environment resulted in approximately 1 bonded joints failure during mechanical pull tests performed at 1.25 times the flight loads. Failure analysis concluded that the failure mode was due to adhesive cracks that formed and propagated along stress concentrated fillets as a result of poor bond squeeze-out control during fabrication. Bond repairs were made and the structures successfully re-tested with an improved LN2 immersion test method to achieve protoflight thermal requirements.

Thermal Vacuum Testing Chamber↗

An Automaton Rover Enabling Long Duration In-Situ Science in Extreme Environments

The Automaton Rover for Extreme Environments (AREE) is a NASA Innovative Advanced Concept (NIAC) funded study focused on enabling long duration science on Venus by replacing vulnerable electronics with an entirely mechanical design. By utilizing high temperature alloys, the rover would survive on the surface of Venus for weeks if not months. The rover concept harvests wind energy using a turbine and stores it in a constant force spring. The mobility system would be guided by a mechanical computer and logic system, programed to carry out the mission. It would collect basic science data such as wind speed, temperature, and seismic events. Communicating the data back to Earth is the most challenging aspect of the system design with multiple options being explored in a trade: a simple electronic high temperature transponder, a retroreflector target or inscribing phonograph style records to be launched via a balloon to a high altitude drone capable of transmitting the data back to Earth. AREE is not only a new exciting in-situ rover concept, but also a paradigm shift to conducting in-situ science in extreme environments. Traditional extreme environment vehicles collect as many diverse data points as possible in the short period of time before system failure. AREE breaks that trend by exploring what can be done with only a few basic scientific measurements, but recorded over long periods of time. In addition to Venus, the concept can be useful in other extreme environments in the solar system including Mercury, Jupiter's radiation belts, the interiors of gas giants, the mantle of the Earth and volcanoes throughout the solar system.

Parness, Aaron↗

Study of a unified hardware and software fault-tolerant architecture

A unified architectural concept, called the Fault Tolerant Processor Attached Processor (FTP-AP), that can tolerate hardware as well as software faults is proposed for applications requiring ultrareliable computation capability. An emulation of the FTP-AP architecture, consisting of a breadboard Motorola 68010-based quadruply redundant Fault Tolerant Processor, four VAX 750s as attached processors, and four versions of a transport aircraft yaw damper control law, is used as a testbed in the AIRLAB to examine a number of critical issues. Solutions of several basic problems associated with N-Version software are proposed and implemented on the testbed. This includes a confidence voter to resolve coincident errors in N-Version software. A reliability model of N-Version software that is based upon the recent understanding of software failure mechanisms is also developed. The basic FTP-AP architectural concept appears suitable for hosting N-Version application software while at the same time tolerating hardware failures. Architectural enhancements for greater efficiency, software reliability modeling, and N-Version issues that merit further research are identified.

Lala, Jaynarayan↗

Oxidation behavior of a thermal barrier coating

Thermal barrier coatings, consisting of a plasma sprayed calcium silicate ceramic layer and a CoCrAlY or NiCrAlY bond coat, were applied on B-1900 coupons and cycled hourly in air in a rapid-response furnace to maximum temperatures of 1030, 1100, or 1160 C. Eight specimens were tested for each of the six conditions of bond-coat composition and temperature. Specimens were removed from test at the onset of failure, which was taken to be the formation of a fine surface crack visible at 10X magnification. Specimens were weighed periodically, and plots of weight gain vs time indicate that weight is gained at a parabolic rate after an initial period where weight was gained at a much greater rate. The high initial oxidation rate is thought to arise from the initially high surface area in the porous bond coat. Specimen life (time to first crack) was found to be a strong function of temperature. However, while test lives varied greatly with time, the weight gain at the time of specimen failure was quite insensitive to temperature. This indicates that there is a critical weight gain at which the coating fails when subjected to this test.

Miller, R. A.↗

Failure detection and isolation methods for redundant gimballed inertial measurement units.

Skewed alignment of two redundant conventional inertial measuring units permits nonambiguous detection and isolation of hard and soft failures in real time by an airborne computer. Accelerometer outputs and gimbal readouts are monitored periodically, and attitude rate and velocity error vectors are computed from these data. Magnitudes of these vectors provide failure detection, and projection of these error vectors onto the coordinate axes of the two clusters permits isolation. A detailed Monte Carlo simulation of one version of the mechanization as applied to Space Shuttle boost trajectories demonstrates effectiveness down to very low levels of inertial instrument performance failures. The results indicate that worst case overall navigation performance occurs when accelerometer failures are of the order of 20 sigma and gyro failures are about 100 sigma for conventional state-of-the-art IMU instruments.

Solov, E. G.↗

Skylab program. Earth resources experiment package. Sensor performance report. Volume 7 (S190B): SL2, SL3 and SL4 evaluations

The S190B Earth Terrain Camera (ETC) operated acceptably for all of its scheduled EREP passes throughout the SL2 mission. The crew reported no problems in unstowing the camera, changing filters, installing the ETC window in the SAL, or installing the camera onto the window. The ETC was operated for a total of seven times with no failures. The clock on the ETC was checked on DOY 170 (June 19, 1973) and was found to be 30 min. and 58 sec. slower than GMT. The change in time was expected since a similar circumstance was experienced during ETC qualification testing for launch vibration. A leak existed in the seal of the spare magazine to the camera vacuum interface. For EREP passes 08 and 10, black-and-white film EK 3414 (roll no. 82) was installed in this spare magazine. Since there was an audible hiss, the vacuum hose was not connected to the camera. This caused the vacuum platen to be inoperable, resulting in some degradation in resolution for this roll of film. The vegetation of the South American jungle areas proved to be much darker than vegetation found in the United States, and was consequently about 1/2 stop underexposed in all cases.

Kenney, G. P.↗

Predicting Failures of Composite, Spherical Pressure Vessels

Long-term viscoelastic effects computed to predict bursts. Spherical pressure vessels commonly made of filamentary composites for applications they must light in weight. Program developed for predicting failure of such vessel over long time span. Short-term failure pressures (bursting points) predicted, but long-term structual integrity of laminated vessels studied only now.

Dozier, J. D.↗