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At least 109 records · Page 6
All sourcesNASA NTRSDOE OSTI
NASA NTRS1977

Cardiovascular studies using the chimpanzee (Pan troglodytes)

Despite the phylogenetic similarities between chimpanzees and man, there exists a paucity of reliable data on normal cardiovascular function and the physiological responses of the system to standard interventions. Totally implanted biotelemetry systems or hardwire analog techniques were used to examine the maximum number of cardiovascular variables which could be simultaneously monitored without significantly altering the system's performance. This was performed in order to acquire base-line data not previously obtained in this species, to determine cardiovascular response to specific forcing functions such as ventricular pacing, drug infusions, and lower body negative pressure. A cardiovascular function profile protocol was developed in order to adjust independently the three major factors which modify ventricular performance, namely, left ventricular performance, left ventricular preload, afterload, and contractility. Cardiac pacing at three levels above the ambient rate was used to adjust end diastolic volume (preload). Three concentrations of angiotensin were infused continuously to evaluate afterload in a stepwide fashion. A continuous infusion of dobutamine was administered to raise the manifest contractile state of the heart.

Hinds, J. E.↗
NASA NTRS1986

Selection of an appropriate animal model for study of bone loss in weightlessness

Prolonged weightlessness in space flight results in a slow progressive demineralization of bone accompanied by an increased calcium output in the urine resulting in negative calcium balances. This possibly irreversible bone loss may constitute a serious limiting factor to long duration manned space flight. A number of preventative measures have been suggested, i.e., exercise during flight, dietary calcium supplements, use of specific prophylactic drugs. In order to facilitate research in these areas it is necessary to develop appropriate ground-based animal models that simulate the human condition of osteoporsis. An appropriate animal model would permit bone density studies, calcium balance studies, biochemical analyses, ground-based simulation models of weightlessness (bed rest, restraint, immobilization) and the planning of inflight experiments. Several animal models have been proposed in the biomedical research literature, but have inherent deficiencies. The purpose of this project was to evaluate models in the literature and determine which of these most closely simulates the phenomenon of bone loss in humans with regard to growth, bone remodeling, structural, chemical and mineralization similarities to human. This was accomplished by a comprehensive computer assisted literature search and report. Three animal models were examined closely for their relative suitability: the albino rat, monkey, and Beagle.

Wolinsky, I.↗
NASA NTRS2007

Pharmacovigilance in Space: Stability Payload Compliance Procedures

Pharmacovigilance is the science of, and activities relating to the detection, assessment, understanding, and prevention of drug-related problems. Over the lase decade, pharmacovigilance activities have contributed to the development of numerous technological and conventional advances focused on medication safety and regulatory intervention. The topics discussed include: 1) Proactive Pharmacovigilance; 2) A New Frontier; 3) Research Activities; 4) Project Purpose; 5) Methods; 6) Flight Stability Kit Components; 7) Experimental Conditions; 8) Research Project Logistics; 9) Research Plan; 10) Pharmaceutical Stability Research Project Pharmacovigilance Aspects; 11) Security / Control; 12) Packaging/Containment Actions; 13) Shelf-Life Assessments; 14) Stability Assessment Parameters; 15) Chemical Content Analysis; 16) Preliminary Results; 17) Temperature/Humidity; 18) Changes in PHysical and Chemical Assessment Parameters; 19) Observations; and 20) Conclusions.

Daniels, Vernie R.↗
NASA NTRS1972

Technology assessment and the Food and Drug Administration

The statutory standards underlying the activities of the FDA, and the problems the Agency faces in decision making are discussed from a legal point of view. The premarketing clearance of new drugs and of food additives, the two most publicized and criticized areas of FDA activity, are used as illustrations. The importance of statutory standards in technology assessment in a regulatory setting is developed. The difficulties inherent in the formulation of meaningful standards are recognized. For foods, the words of the statute are inadequate, and for drugs, a statutory recognition of the various other objectives would be useful to the regulator and the regulated.

Kaplan, A. H.↗
NASA NTRS2010

Atrial Fibrillation During an Exploration Class Mission

Background: A long-duration exploration class mission is fraught with numerous medical contingency plans. Herein, we explore the challenges of symptomatic atrial fibrillation (AF) occurring during an exploration class mission. The actions and resources required to ameliorate the situation, including the availability of appropriate pharmaceuticals, monitoring devices, treatment modalities, and communication protocols will be investigated. Challenges of Atrial Fibrillation during an Exploration Mission: Numerous etiologies are responsible for the initiation of AF. On Earth, we have the time and medical resources to evaluate and determine the causative situation for most cases of AF and initiate therapy accordingly. During a long-duration exploration class mission resources will be severely restricted. How is one to determine if new onset AF is due to recent myocardial infarction, pulmonary embolism, fluid overload, thyrotoxicosis, cardiac structural abnormalities, or CO poisoning? Which pharmaceutical therapy should be initiated and what potential side effects can be expected? Should anti-coagulation therapy be initiated? How would one monitor the therapeutic treatment of AF in microgravity? What training would medical officers require, and which communication strategies should be developed to enable the best, safest therapeutic options for treatment of AF during a long-duration exploration class mission? Summary: These questions will be investigated with expert opinion on disease elucidation, efficient pharmacology, therapeutic monitoring, telecommunication strategies, and mission cost parameters with emphasis on atrial fibrillation being just one illustration of the tremendous challenges that face a long-duration exploration mission. The limited crew training time, medical hardware, and drugs manifested to deal with such an event predicate that aggressive primary and secondary prevention strategies be developed to protect a multibillion-dollar asset like the International Space Station or a mission to the Moon or Mars. Learning Objectives: The audience will become familiar with the risks and challenges inherent to developing a therapeutic strategy for the treatment of atrial fibrillation during a long-term exploration class mission.

Lipset, Mark A.↗
NASA NTRS1995

IMS R and D program at Canada customs

Over the last few years, Revenue Canada, in collaboration with Barringer Instruments Limited, has been involved in the development of a field-usable ion mobility spectrometer (IMS) for the detection of drugs of abuse. This work has culminated in the manufacturing and commercialization by Barringer of the Ionscan 350 instruments, now in use by various law enforcement agencies worldwide. Although IMS exhibits a very strong and distinctive response toward some nitrogen containing drugs, e.g., cocaine, like all separation techniques it has inherent limitations, namely moderate resolution and low chemical signal to noise ratio which may affect the reliability of IMS-based drug detectors. A program is in place at the Laboratory and Scientific Services Directorate (LSSD) to investigate the applicability of various digital signal processing (DSP) techniques to IMS output signals. The application of neural network techniques to overlapping IMS peaks is presented.

Pilon, Pierre↗
NASA NTRS1993

Study of various NH4+/NO3- mixtures for enhancing growth of potatoes

Two experiments were conducted to determine the effects of various NH4(+)-N/NO3(-)-N percentages on growth and mineral concentrations in potato (Solanum tuberosum L.) plants using a non-recirculating nutrient film system in a controlled environment. The first experiment included six NH4(+)-N/NO3(-)-N percentages at 0/100, 20/80, 40/60, 60/40, 80/20, and 100/0 with the same total N concentration of 4 mM. The second experiment included six NH4(+)-N/NO3(-)-N percentages at 0/100, 4/96, 8/92, 12/88, 16/84, and 20/80 again with the same total N of 4 mM. In each experiment, plants were harvested 35 days after transplanting when tubers had been initiated and started to enlarge. Dry weights of shoots, tubers, and whole plant at the harvest were increased significantly with all mixed nitrogen treatments as compared with single NH4+ or NO3- form. The enhanced growth with mixed nitrogen was greatest at 8% to 20% NH4(+)-N. Also, the concentrations and accumulation of total N in the shoots and roots were greater with mixed nitrogen than with separate NH4+ or NO3- nutrition. With NH4+ present in the solutions, the concentrations of P and Cl in the shoots were increased compared to NO3- alone, whereas the tissue concentrations of Ca and Mg were decreased. It was concluded that nitrogen fertilization provided with combined NH4+ and NO3- forms, even at small proportions of NH4+, can enhance nitrogen uptake and productivity in potato plants.

NASA Program CELSS↗
NASA NTRS2002

Dynamic Light-Scattering Probe Used for the Very Early Detection of Cataracts and to Measure Response to Therapy (or Treatment)

Half of all blindness worldwide is due to cataracts, and 34 million Americans over the age of 65 have cataracts. This figure is expected to rise to 70 million by the year 2030. Currently, no medical treatment is available to prevent or halt the progression of a cataract; nor is there any way to reverse a cataract once it has been detected by conventional methods. The only known treatment is surgical removal of the lens. It is estimated that over $5 billion will be spent this year for the treatment of cataract patients in the United States alone. According to Carl Kupfer, M.D., former Director of the National Eye Institute at the National Institutes of Health, "A delay in cataract formation of about 10 years would reduce the prevalence of visually disabling cataracts by about 45 percent." However, this vision remains a dream because of the lack of objective methods that can be used to detect cataracts very early and, hence, can be used for screening potential anticataract drugs. This is about to change. The National Eye Institute and NASA entered into a formal interagency agreement in late 1996 to develop and test a dynamic light-scattering (DLS) device to detect the earliest changes due to cataract formation. The new DLS probe developed by Dr. Ansari at the NASA Glenn Research Center is several orders of magnitude more sensitive than conventional clinical systems. This ultrahigh sensitivity enables the probe to detect the onset of a cataract before it has any effect on vision and allows researchers to test the effectiveness of anticataract drugs in reversing cataracts. This device (see the following illustration) was originally designed to study transport phenomena in microgravity fluid physics experiments onboard the space shuttle orbiters and space station. It will be very useful in testing anticataract drugs to halt or reverse the progression of cataracts during longitudinal clinical trials.

Ansari,Rafat R.↗
NASA NTRS2012

Wireless Self-Acquistion of 12-Lead ECG via Android Smart Phone

Researchers at NASA s Johnson Space Center and at Orbital Research, Inc. (a NASA SBIR grant recipient) have recently developed a dry-electrode harness that allows for self-acquisition of resting 12-lead ECGs by minimally trained laypersons. When used in conjunction with commercial wireless (e.g., Bluetooth(TM) or 802.11-enabled) 12-lead ECG devices and custom smart phone-based software, the collected 12-lead ECG data can also immediately be forwarded from any geographic location within cellular range to the user s physician(s) of choice. The system can also be used to immediately forward to central receiving stations 12-lead ECG data collected during space flight or during activities in any remote terrestrial location supported by an internet or cellular phone infrastructure. The main novel aspects of the system are first, the dry-electrode 12-lead ECG harness itself, and second, an accompanying Android(TM) smart phone-based wireless 12-lead ECG capability. The ECG harness nominally employs dry electrodes manufactured by Orbital Research, Inc, recently cleared through the Food and Drug Administration (FDA). However, other dry electrodes that are not yet FDA cleared, for example those recently developed by Nanosonic, Inc as part of another NASA SBIR grant, can also be used. The various advantageous features of the harness include: 1) laypersons can be quickly instructed on its correct use, remotely if necessary; 2) all tangled "leadwire spaghetti" is eliminated, as is the common clinical problem of "leadwire reversal"; 3) all adhesives and disposables are also eliminated, the harness being fully reusable; if multiple individuals intend to use use the same harness, then standard antimicrobial wipes can be employed to sterilize the dry electrodes (and harness surface if needed) between users; 5) padded cushions at the lateral sides of the torso function to press the left arm (LA) and right arm (RA) dry electrodes mounted on the cushions against sideward or downward-rested arms of the subject; 6) sufficient distal placement of the arm electrodes achieves good electrode abutment to the arms without the need for adhesives, straps, bands, bracelets, or gloves; 7) padding over the sternum avoids "tenting" in the V1 through V3 (and, when present, the V3R) electrode positions; 8) easy-to-don, one-piece design with an adjustable, front-side single point of connection and an adjustable shoulder strap; and 9) Lund or "modified Lund" placement of the dry electrodes, the results of which more effectively reproduce results from "standard" 12-lead ECG placements than do results from Mason-Likar placements. The main limitation of the harness is that "one size does not fit all", meaning that an appropriately sized harness (small, medium, large, etc) must be chosen on the basis of an individual's size. To facilitate the use of the harness with inexpensive, commodity-grade cell phones and tablet devices, 12-lead ECG software is also being developed to accompany the harness for wireless use with Android. For this part of the project, NASA has teamed with TopCoder, Inc and the Harvard-affiliated NASA Tournament Lab in sponsoring java-based software programming contests through TopCoder. While ECG signals from the harness can already be wirelessly received and thoroughly processed (locally or remotely) by commercial-grade conventional (as well as advanced) 12-lead ECG software running on Microsoft Windows(TM), the Android-based software, once completed, will "cast a wider net" by allowing for a greater percentage of cell phone owners to participate in inexpensive, store-and-forward recordings of 12-lead ECGs worldwide, including for example Android cell phone users in many remote, third-world locations. At the time of writing, the Android 12-lead ECG software platform consists of a basic but expanding graphical user interface and accompanying software that: 1) wirelessly receives the 12-lead ECG data stream from a Bluetooth-based, FDA-cleared 12-leaCG device attached to the harness; 2) locally stores the same data in binary format to the SD card on the Android cell phone; and 3) makes the data stream in available in real time, for now to TopCoder's java programming contestants.

Schlegel, Todd T.↗
NASA NTRSDate not supplied

Decision Framework for Classifying the State of Knowledge for Pharmaceutical Stability in Spaceflight

The currently approved medication formulary for exploration-class spaceflight missions presently exceeds 200pharmaceuticals. However, these medications' physical and chemical stability during long-term exposure to the spaceflight environment remains uncharacterized. A multi-disciplinary team of pharmacy and spaceflight subject matter experts (SMEs) collaborated to develop a decision framework that will prioritize medications for future stability research. This framework prioritizes the physical stability, drug quality, and safety of the active pharmaceutical ingredient of finished drug products selected for specific design reference mission (DRM) drug formularies. The United States Pharmacopeia (USP) defines drug stability as "the extent to which a drug product retains, within specified limits, and throughout its period of storage and use, the same properties and characteristics that it possessed at the time of its manufacture.1"The candidate medication is assessed by applying a sequence of drug agnostic questions to evaluate the limits of stability information pertinent to spaceflight. The answers to these questions ultimately lead to one of three characterizations: green (not prioritized for further research for this DRM), yellow (requires further literature review/additional studies), or red (not suitable for this DRM based on current knowledge). The decision framework will rely on several information resources to inform the ultimate decision, including the ExMC Pharmacy Information Database, published literature, FDA/drug manufacturer monographs, and USP. The results of this framework will be used to classify the state of knowledge for pharmaceutical stability for any specified DRM and guide future research efforts accordingly. This presentation will provide an overview of how this decision framework was developed, detail the challenges and limitations of the pathways, and discuss how researchers can apply the lessons learned from this project to future work

S Kurian↗
NASA NTRS1982

Spinoff from Space Fuel

In 1963, under contract with NASA, Air Products and Chemicals, Inc. built a 32 1/2 ton-a-day plant to meet the soaring demand for liquid hydrogen created by the Apollo missions and J-2 ground testing. Air Product's experience in government research, development and production of liquid hydrogen served as the springboard for a broad variety of practical, Earth-use applications. Today, liquid hydrogen is widely used among many industries including petroleum refineries in gasoline production and chemical and pharmaceutical firms in the manufacturing of fertilizers and drugs. New commercial applications are growing at the rate of about ten percent per year. Input from government research, Air Product's own technology development, and the large space program requirements combined to make the company the prime manufacturer of liquid hydrogen and enabled them to add a new 30-ton plant near New Orleans.

Source record↗
NASA NTRS1986

The effect of antimotion sickness drugs on habituation to motion

The mechanism which allows for increased exposure to motion and accelerates habituation is investigated. The responses of 12 male and female subjects between 18-30 years rotated once a day for 5 days on the Contraves Goerz rotating chair after receiving placebo, 10 mg d-amphetamine, 0.6 mg scopolamine with 5 mg d-amphetamine, and 1.0 mg scopolamine are studied. It is observed that with placebo the subjects performed 48 more head movements than untreated subjects, 118 more movements with d-amphetamine, 176 more with 0.6 mg scopolamine with d-amphetamine, and 186 more with 1.0 scopolamine. The data reveal that exposure to rotation increases tolerance from 88 head movements on day 2 to 159 on day 4 at 17.4 rpm and with placebo; 96 to 186 at 19.9 rpm with 10 mg d-amphetamine; 111 to 273 at 20.2 rpm with scopolamine with d-amphetamine, and 141 to 279 at 22.4 rpm with 1.0 mg scopolamine. It is noted that a combination of cholinergic blocking and norepinephrine activation action is most effective in preventing the development of motion sickness and habituation is due to the greater exposure to vestibular simulation permitted by the drugs.

Wood, C. D.↗
NASA NTRS1988

Balance System

TherEx Inc.'s AT-1 Computerized Ataxiameter precisely evaluates posture and balance disturbances that commonly accompany neurological and musculoskeletal disorders. Complete system includes two-strain gauged footplates, signal conditioning circuitry, a computer monitor, printer and a stand-alone tiltable balance platform. AT-1 serves as assessment tool, treatment monitor, and rehabilitation training device. It allows clinician to document quantitatively the outcome of treatment and analyze data over time to develop outcome standards for several classifications of patients. It can evaluate specifically the effects of surgery, drug treatment, physical therapy or prosthetic devices.

Source record↗
NASA NTRS1981

Compound Separation

Jet Propulsion Laboratory developed a new one-step liquid-liquid extraction technique which cuts processing time, reduces costs and eliminates much of the equipment required. Technique employs disposable extraction columns, originally developed as an aid to the Los Angeles Police Department, which allow more rapid detection of drugs as part of the department's drug abuse program. Applications include medical treatment, pharmaceutical preparation and forensic chemistry. NASA waived title to Caltech, and Analytichem International is producing Extubes under Caltech license.

Source record↗
NASA NTRS2006

Midodrine Exacerbates Promethazine-induced Akathisia

The study of physiological changes during spaceflight, and the pursuit of remedies to counteract those changes, often requires unique research protocols that lead to unexpected findings; some with important clinical implications. In our research into the development of treatments to counteract the detrimental cardiovascular effects of spaceflight, we have discovered an important drug interaction between promethazine and midodrine.

Platts, Steven H.↗
NASA NTRS2002

Development of a New Membrane Casting Apparatus for Studying Macrovoid Defects in Low-G

A new membrane-casting apparatus is developed for studying macrovoid defects in polymeric membranes made by the wet- and dry-casting process in low-gravity. Macrovoids are large (10-50 micron), open cavities interspersed among the smaller pores in the substructure under the gelled skin surface layer of the cast membrane. Although their occurrence is considered endemic to the wet- and dry-casting process since they can lead to compaction or skin rupture in the membrane process, recent studies suggest several useful applications such as transdermal and osmotic drug delivery systems, miniature bioreactors, etc. However, lack of knowledge about the macrovoid formation mechanism is an obstacle to further development of applications using them. An on-going debate is the role of the surface-tension-driven solutocapillary convection during macrovoid formation. The rapid growth of macrovoids within 1-5 seconds and the high polymer concentration in and near macrovoids make it difficult to explain the mechanism of macrovoid growth by diffusion alone, which is the widely accepted hypothesis proposed by Reuvers et al. The hypothesis advanced by our research group can explain this rapid growth via a mechanism that involves diffusion from the casting solution in the meta-stable region to the macrovoid enhanced by solutocapillary convection induced by the steep nonsolvent concentration gradient in the vicinity of the macrovoid. Since macrovoid growth is hypothesized to be the interplay of a solutocapillary-induced driving force counteracted by viscous drag and buoyancy, eliminate the latter provides a means for testing this hypothesis. Moreover, free convection mass transfer in the nonsolvent immersion bath used to cause phase-separation in membrane casting complicates developing a model for both the wet-casting process and macrovoid growth. The low-g environment minimizes gravitationally induced free convection thereby permitting a tractable solution to the ternary diffusion equations that characterize membrane formation. NASA's Parabolic Flight Research Aircraft provides a small window of low-g (approximately 25 s) that can be used to study macrovoid development in both wet- and dry-cast membranes if an appropriate casting apparatus is used. This casting apparatus should be able to cast the membrane in both low- and high-g in a manner so that essential one-dimensional mass transfer conditions are achieved to insure lateral uniformity in the membrane. The apparatus used in previous research on membrane casting in low-gravity was operated with the plunger driven mechanism. The spring-loaded plunger pushes the bottom block containing the polymer casting solution well directly under the absorbent chamber located in the upper stationary block. However, membranes made via this casting apparatus often displayed lateral nonuniformities that precluded obtaining quantitative information on the macrovoid growth process. Thus, it was necessary to determine the reason for these structural irregularities observed in the low-g casting apparatus. Both experimental as well as computer simulation studies of the low-g casting apparatus established that the impulsive action of the plunger caused the undesired structural nonuniformities. The simulation results showed that the width-to-depth aspect ratio of the shallow well that contains the casting solution in this apparatus was not an important factor in minimizing this problem. Even for a 40:1 (width : depth) aspect ratio, any convection induced by the horizontal motion of the interface of the casting solution will be damped out within 6.25x10(exp 4) seconds. However, the experimental studies revealed that the impulsive motion of the plunger caused a 'sloshing' of the casting solution that had to be eliminated. Therefore, the plungerdriven mechanism was changed to a cam-driven mechanism that did not cause any impulsive motion of the casting solution. Other refinements to this new membrane-casting apparatus include provision for removing the membranes from the casting wells in a less destructive manner. This was accomplished by using a slit geometry for the casting well that permitted disassembly for removal of the cast membrane. The materials used in the construction of this casting apparatus were chosen to insure wetting at the side walls and to maintain precise control of the thickness of the polymer solution in the casting well. An additional provision in this new casting apparatus is the ability to carry out both wet- as well as dry-casting. As such, this apparatus permitted the first studies of the wet-casting of polymeric membranes in low-g. Both wet- and dry-casting experiments on NASA's KC-135 research aircraft employing this new membrane-casting apparatus are scheduled in July 2002. The morphology of the resulting membranes will be characterized using an environmental scanning electron microscope (ESEM). The results of these low-g studies will be reported later.

Lee, Hanyong↗
NASA NTRS1991

Optimal sampling theory and population modelling - Application to determination of the influence of the microgravity environment on drug distribution and elimination

The optimal sampling theory is evaluated in applications to studies related to the distribution and elimination of several drugs (including ceftazidime, piperacillin, and ciprofloxacin), using the SAMPLE module of the ADAPT II package of programs developed by D'Argenio and Schumitzky (1979, 1988) and comparing the pharmacokinetic parameter values with results obtained by traditional ten-sample design. The impact of the use of optimal sampling was demonstrated in conjunction with NONMEM (Sheiner et al., 1977) approach, in which the population is taken as the unit of analysis, allowing even fragmentary patient data sets to contribute to population parameter estimates. It is shown that this technique is applicable in both the single-dose and the multiple-dose environments. The ability to study real patients made it possible to show that there was a bimodal distribution in ciprofloxacin nonrenal clearance.

Drusano, George L.↗
NASA NTRS1993

Mass balance approaches for estimating the intestinal absorption and metabolism of peptides and analogues: theoretical development and applications

A theoretical analysis for estimating the extent of intestinal peptide and peptide analogue absorption was developed on the basis of a mass balance approach that incorporates convection, permeability, and reaction. The macroscopic mass balance analysis (MMBA) was extended to include chemical and enzymatic degradation. A microscopic mass balance analysis, a numerical approach, was also developed and the results compared to the MMBA. The mass balance equations for the fraction of a drug absorbed and reacted in the tube were derived from the general steady state mass balance in a tube: [formula: see text] where M is mass, z is the length of the tube, R is the tube radius, Pw is the intestinal wall permeability, kr is the reaction rate constant, C is the concentration of drug in the volume element over which the mass balance is taken, VL is the volume of the tube, and vz is the axial velocity of drug. The theory was first applied to the oral absorption of two tripeptide analogues, cefaclor (CCL) and cefatrizine (CZN), which degrade and dimerize in the intestine. Simulations using the mass balance equations, the experimental absorption parameters, and the literature stability rate constants yielded a mean estimated extent of CCL (250-mg dose) and CZN (1000-mg dose) absorption of 89 and 51%, respectively, which was similar to the mean extent of absorption reported in humans (90 and 50%). It was proposed previously that 15% of the CCL dose spontaneously degraded systematically; however, our simulations suggest that significant CCL degradation occurs (8 to 17%) presystemically in the intestinal lumen.(ABSTRACT TRUNCATED AT 250 WORDS).

Non-NASA Center↗