Search NASA⌕ Search

SEARCH · Search NASA

Results for “clinical development”

Search indexed NASA NTRS and DOE OSTI research on propulsion, heat transfer, battery materials and energy systems. Follow report and document links to the original sources.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 37 records · Page 2
All sourcesNASA NTRSDOE OSTI
NASA NTRS2011

An Integrated Musculoskeletal Countermeasure Battery for Long-Duration Lunar Missions

During extended periods of skeletal unloading, losses in strength and density of the proximal femur will occur. In long-duration spaceflight, resistive exercise is used to replace the normal loads exerted on the spine and hip. At the present time, there is no conclusive evidence that hip bone loss has been prevented in this scenario. Our group has recently developed and clinically evaluated a multifunctional exercise system, the Combined Countermeasure Device (CCD). The CCD comprises a low-footprint Stuart Platform for lower-body resistance exercise and balance training, and a cardiovascular exercise bicycle. A consideration for resistance exercise was targeting of the hip abductor and adductor muscles, which attach directly at the hip and which should subject it to the largest loads. In our training study, we found that CCD exercise increased hip adductor and abductor strength, and modeling results suggest that this exercise exerts forces on the hip of approx. 4-6 body weights at 1g, compared to forces of approx.2.5 body weight y squatting exercise. In our current study, we hypothesize that abductor and adductor exercise will increase the density and strength of the proximal femur.

Lang, T. F.↗
NASA NTRS2012

A Hypothesis on Biological Protection from Space Radiation Through the Use of New Therapeutic Gases as Medical Counter Measures

Radiation exposure to astronauts could be a significant obstacle for long duration manned space exploration because of current uncertainties regarding the extent of biological effects. Furthermore, concepts for protective shielding also pose a technically challenging issue due to the nature of cosmic radiation and current mass and power constraints with modern exploration technology. The concern regarding exposure to cosmic radiation is the biological damage it induces. As damage is associated with increased oxidative stress, it is important and would be enabling to mitigate and/or prevent oxidative stress prior to the development of clinical symptoms and disease. This paper hypothesizes a "systems biology" approach in which a combination of chemical and biological mitigation techniques are used conjunctively. It proposes using new, therapeutic, medical gases as both chemical radioprotectors for radical scavenging and biological signaling molecules for management of the body s response to exposure. From reviewing radiochemistry of water, biological effects of CO, H2, NO, and H2S gas, and mechanisms of radiation biology, it is concluded that this approach may have great therapeutic potential for radiation exposure. Furthermore, it also appears to have similar potential for curtailing the pathogenesis of other diseases in which oxidative stress has been implicated including cardiovascular disease, cancer, chronic inflammatory disease, hypertension, ischemia/reperfusion injury, acute respiratory distress syndrome, Parkinson s and Alzheimer s disease, cataracts, and aging.

Schoenfeld, Michael P.↗
NASA NTRS2011

A Hypothesis on Biological Protection from Space Radiation Through the Use of New Therapeutic Gases

Radiation exposure to astronauts could be a significant obstacle for long duration manned space exploration because of current uncertainties regarding the extent of biological effects. Furthermore, concepts for protective shielding also pose a technically challenging issue due to the nature of cosmic radiation and current mass and power constraints with modern exploration technology. The concern regarding exposure to cosmic radiation is the biological damage it induces. As damage is associated with increased oxidative stress, it is important and would be enabling to mitigate and/or prevent oxidative stress prior to the development of clinical symptoms and disease. This paper hypothesizes a "systems biology" approach in which a combination of chemical and biological mitigation techniques are used conjunctively. It proposes using new, therapeutic, medical gases as both chemical radioprotectors for radical scavenging and biological signaling molecules for management of the body s response to exposure. From reviewing radiochemistry of water, biological effects of CO, H2, NO, and H2S gas, and mechanisms of radiation biology, it is concluded that this approach may have great therapeutic potential for radiation exposure. Furthermore, it also appears to have similar potential for curtailing the pathogenesis of other diseases in which oxidative stress has been implicated including cardiovascular disease, cancer, chronic inflammatory disease, hypertension, ischemia/reperfusion injury, acute respiratory distress syndrome, Parkinson s and Alzheimer s disease, cataracts, and aging.

Schoenfeld, Michael P.↗
NASA NTRS2011

A Hypothesis on Biological Protection from Space Radiation Through the Use of New Therapeutic Gases as Medical Counter Measures

Exposure to astronauts could be a significant obstacle for long duration manned space exploration because of current uncertainties regarding the extent of biological effects. Furthermore, concepts for protective shielding also pose a technically challenging issue due to the nature of cosmic radiation and current mass and power constraints with modern exploration technology. As biological damage from exposure is associated with increased oxidative stress, it would be enabling to mitigate and/or prevent stress prior to the development of clinical symptoms and disease. This paper hypothesizes a "systems biology" approach in which a combination of chemical and biological mitigation techniques are used conjunctively. It proposes using new, therapeutic, medical gases as both chemical radioprotectors for radical scavenging and biological promoters for management of the body s response to exposure. From reviewing radiochemistry of water, biological effects of CO, H2, NO, and H2S gas, and mechanisms of radiation biology, it is concluded that this approach may have great therapeutic potential for exposure. Furthermore, it also appears to have potential for curtailing the pathogenesis of other diseases in which oxidative stress has been implicated including cardiovascular disease, cancer, chronic inflammatory disease, hypertension, ischemia/reperfusion injury, acute respiratory distress syndrome, Parkinson s and Alzheimer s disease, cataracts, and aging.

Schoenfeld, Michael P.↗
NASA NTRS2014

Miniaturized, Portable Sensors Monitor Metabolic Health

In order to measure astronauts' metabolic rates in space, Glenn Research Center partnered with Case Western University and the Cleveland Clinic to develop the Portable Unit for Metabolic Analysis (PUMA). Cleveland-based Orbital Research licensed and then modified PUMA to help the US Navy assess pilot oxygen problems and is now designing a device that can be used in hospitals.

Source record↗
NASA NTRSDate not supplied

Developing Mission Segment-Specific Clinical Data for Impact

Space exploration missions represent a significant future objective for NASA’s human spaceflight operations for the near and long term. By operating missions during longer periods and over further distances, NASA’s mission planning models, hardware systems, and medical capabilities will be stretched beyond their original design constraints. The necessity of medical training and medical supply manifesting for such missions is likely to become incredibly intricate as trade-space analysis is performed over varying mission profiles. For this purpose, IMPACT was created to extend and improve the Integrated Medical Model (IMM) which is used for International Space Station (ISS) medical predications and consists of a probabilistic risk assessment tool that simulates missions to calculate risks given the constraints on crew complement, mission duration and activity (such as Extravehicular Activities), power, communication, mass, volume, and evacuation consideration as well as to predict mission outcomes. Currently, the medical evidence used to support IMPACT remains static, addressing risks of a medical condition and the impacts of the condition during spaceflight only, but is only calculated for a small number of mission parameters. Extended missions will consist of new and varied living environments, changing gravitational loads, and dynamic working requirements. Medical risks are not typically constant but will change depending upon the physical and physiological environment of the body during all phases of a mission. Risks are likely to shift during different mission segments, and understanding how components of a mission profile change risks will assist mission planners to increase chances for mission success.

Christopher Zahner↗
NASA NTRSDate not supplied

Clinical Decision Support - Concepts of Operation

We are entering a new era in space exploration to return to the moon and explore Mars. Crew members operating independently during long duration space exploration missions will require a clinical decision support system (CDSS) to increase autonomy by augmenting their knowledge, skills and abilities in different scenarios. Significant changes to in-flight and habitat medical care due to constraints on mass, volume, power, crew time and medical evacuation capabilities are needed to increase crew autonomy and self-reliance in decision making and task performance. The Exploration Medical Capability (ExMC) Element of the Human Research Program (HRP) pushes the boundary of space medical systems to advance the care of astronauts on future exploration missions beyond low Earth orbit by identifying and testing next-generation medical care and crew health maintenance technologies. Clinical decision support (CDS) presents knowledge and data in a context aware manner to augment a crew members’ knowledge, skills and abilities during the process of observation, orientation, decisions and action. A comprehensive crew health and performance CDSS is required to augment crew capability and will be used in different scenarios for several reasons. In general, the CDSS’s role is to assist the crew in prevention, detection, diagnosis and treatment of crew health and performance related conditions that may arise in exploration spaceflight. For example, CDSS would assist a high acuity scenario such as a heart attack by supplying clear instructions, vital signs and treatment reminders. A lower severity scenario such as kidney stone risk could interface to vehicle systems and display more complex predictive data during a diagnosis. A CDSS needs to contribute to successful missions by maintaining a high performing crew who can potentially exhibit countless medical conditions related to derangements from the space environment (sleep, cognition, nutrition and exercise) as well as conditions intrinsic to humans anywhere. While supporting the crew’s ability to make sound clinical decisions is desirable in any mission, it is essential for exploration missions with significant communication delays, no evacuation capability, and extended exposure to the flight environment. Such missions correspond with medical Level of Care V (LOC V), the highest level specified in NASA-STD-3001. The project focuses on CDS implementation research to derive requirements for LOC V, where the need for increased autonomy results in new practices and the inclusion of non-clinical data, such as vehicle environmental measures and physical exercise results, from other human and vehicle domains and advanced analytics. The CDS project describes how the CDSS is intended to be used by defining concepts of operations (ConOps). The process to derive ConOps focuses on increased autonomy that reduces the likelihood and consequences of accepted medical conditions. These crew health and performance inputs are grouped by common datasets and analysis models. Use cases are derived to research new clinical scenarios, architectural development and workflows. Implementation research is conducted with protypes to inform assumptions and derive requirements. The project also establishes how externally developed analysis and approaches can be added to expand a clinical decision support system and thus highlight how a comprehensive system can be globally developed with collaborators. This presentation will cover example scenarios from the CDS ConOps and the method to derive them. One example scenario will be CDSS alerting an increased kidney stone risk during a mission, with diagnosis and treatment options provided during the intervention.

clinical decision support↗
NASA NTRSDate not supplied

Clinical Decision Support - Concepts of Operation

We are entering a new era in space exploration to return to the moon and explore Mars. Crew members operating independently during long duration space exploration missions will require a clinical decision support system (CDSS) to increase autonomy by augmenting their knowledge, skills and abilities in different scenarios. Significant changes to in-flight and habitat medical care due to constraints on mass, volume, power, crew time and medical evacuation capabilities are needed to increase crew autonomy and self-reliance in decision making and task performance. The Exploration Medical Capability (ExMC) Element of the Human Research Program (HRP) pushes the boundary of space medical systems to advance the care of astronauts on future exploration missions beyond low Earth orbit by identifying and testing next-generation medical care and crew health maintenance technologies. Clinical decision support (CDS) presents knowledge and data in a context aware manner to augment a crew members’ knowledge, skills and abilities during the process of observation, orientation, decisions and action. A comprehensive crew health and performance CDSS is required to augment crew capability and will be used in different scenarios for several reasons. In general, the CDSS’s role is to assist the crew in prevention, detection, diagnosis and treatment of crew health and performance related conditions that may arise in exploration spaceflight. For example, CDSS would assist a high acuity scenario such as a heart attack by supplying clear instructions, vital signs and treatment reminders. A lower severity scenario such as kidney stone risk could interface to vehicle systems and display more complex predictive data during a diagnosis. A CDSS needs to contribute to successful missions by maintaining a high performing crew who can potentially exhibit countless medical conditions related to derangements from the space environment (sleep, cognition, nutrition and exercise) as well as conditions intrinsic to humans anywhere. While supporting the crew’s ability to make sound clinical decisions is desirable in any mission, it is essential for exploration missions with significant communication delays, no evacuation capability, and extended exposure to the flight environment. Such missions correspond with medical Level of Care V (LOC V), the highest level specified in NASA-STD-3001. The project focuses on CDS implementation research to derive requirements for LOC V, where the need for increased autonomy results in new practices and the inclusion of non-clinical data, such as vehicle environmental measures and physical exercise results, from other human and vehicle domains and advanced analytics. The CDS project describes how the CDSS is intended to be used by defining concepts of operations (ConOps). The process to derive ConOps focuses on increased autonomy that reduces the likelihood and consequences of accepted medical conditions. These crew health and performance inputs are grouped by common datasets and analysis models. Use cases are derived to research new clinical scenarios, architectural development and workflows. Implementation research is conducted with protypes to inform assumptions and derive requirements. The project also establishes how externally developed analysis and approaches can be added to expand a clinical decision support system and thus highlight how a comprehensive system can be globally developed with collaborators. This presentation will cover example scenarios from the CDS ConOps and the method to derive them. One example scenario will be CDSS alerting an increased kidney stone risk during a mission, with diagnosis and treatment options provided during the intervention.

clinical decision support↗
NASA NTRS2015

Clinical Outcome Metrics for Optimization of Robust Training

The objective of this research is to develop and use clinical outcome metrics and training tools to quantify the differences in performance of a physician vs non‐physician crew medical officer (CMO) analogues during simulations.

Ebert, Doug↗
NASA NTRS2003

Evaluation of Human Research Facility Ultrasound With the ISS Video System

Most medical equipment on the International Space Station (ISS) is manifested as part of the U.S. or the Russian medical hardware systems. However, certain medical hardware is also available as part of the Human Research Facility. The HRF and the JSC Medical Operations Branch established a Memorandum of Agreement for joint use of certain medical hardware, including the HRF ultrasound system, the only diagnostic imaging device currently manifested to fly on ISS. The outcome of a medical contingency may be changed drastically, or an unnecessary evacuation may be prevented, if clinical decisions are supported by timely and objective diagnostic information. In many higher-probability medical scenarios, diagnostic ultrasound is a first-choice modality or provides significant diagnostic information. Accordingly, the Clinical Care Capability Development Project is evaluating the HRF ultrasound system for its utility in relevant clinical situations on board ISS. For effective management of these ultrasound-supported ISS medical scenarios, the resulting data should be available for viewing and interpretation on the ground, and bidirectional voice communication should be readily available to allow ground experts (sonographers, physicians) to provide guidance to the Crew Medical Officer. It may also be vitally important to have the capability of real-time guidance via video uplink to the CMO-operator during an exam to facilitate the diagnosis in a timely fashion. In this document, we strove to verify that the HRF ultrasound video output is compatible with the ISS video system, identify ISS video system field rates and resolutions that are acceptable for varying clinical scenaiios, and evaluate the HRF ultrasound video with a commercial, off-the-shelf video converter, and compare it with the ISS video system.

Melton, Shannon↗
NASA NTRS2003

Lunar Surface Reference Missions: A Description of Human and Robotic Surface Activities

Most medical equipment to the International Space Station (ISS) is manisfested as part of the U.S. or the Russian medical hardware systems. However, certain medical hardware is also available as part of the Human Research Facility. The HRF and the JSC Medical Operations Branch established a Memorandum of Agreement for joint use of certain medical hardware, including the HRF ultrasound system, the only diagnostic imaging device currently manifested to fly on ISS. The outcome of a medical contingency may be changed drastically, or an unnecessary evacuation may be prevented, if clinical decisions are supported by timely and objective diagnostic information. In many higher-probability medical scenarios, diagnostic ultrasound is a first-choice modality or provides significant diagnostic information. Accordingly, the Clinical Care Capability Development Project is evaluating the HRF ultrasound system for its utility in relevant clinical siruations on board ISS. For effective management of these ultrasound-supported ISS medical scenarios, the resulting data should be available for viewing and interpretation on the ground, and bidirectional voice communication should be readily available to allow ground experts (sonographers, physicians) to provide guidance to the Crew Medical Officer. It may also be vitally important to have the capability of real-time guidance via video uplink to the CMO-opertor during an exam to facilitate the diagnosis in a timely fashion.

Duke, Michael B.↗
NASA NTRS1997

Flow Analysis of the Cleveland Clinic Centrifugal Pump

An implantable ventricular assist rotordynamic blood pump is being developed by the Cleveland Clinic Foundation in cooperation with the NASA Lewis Research Center. At the nominal design condition, the pump provides blood flow at the rate of 5 liters per minute at a pressure rise of 100 mm of mercury and a rotative speed of 3000 RPM. Bench testing of the centrifugal pump in a water/glycerin mixture has provided flow and pressure data at several rotative speeds. A one-dimensional empirical based pump flow analysis computer code developed at NASA Lewis Research Center has been used in the design process to simulate the flow in the primary centrifugal pump stage. The computer model was used to size key impeller and volute geometric parameters that influence pressure rise and flow. Input requirements to the computer model include a simple representation of the pump geometry. The model estimates the flow conditions at the design and at off-design operating conditions at the impeller leading and trailing edges and the volute inlet and exit. The output from the computer model is compared to flow and pressure data obtained from bench testing.

Veres, Joseph P.↗
NASA NTRS1991

Psychiatric diagnoses in a group of astronaut applicants

Between 1959 and 1987, the psychiatric evaluation of astronaut candidates evolved from a 30-h intensive examination evaluating applicants for psychopathology, and studying their performance under stress, to a 2-h clinical interview whose structure and contents were determined by the individual examiner. Evaluations done during these years applied both psychiatric (or, 'select-out') criteria and psychological (or, 'select-in') criteria. In an attempt to more rigorously define the psychiatric, 'select-out' component, a standardized, semistructured clinical interview was developed to identify the presence or history of psychiatric disorders listed in the Diagnostic and Statistical Manual of Mental Disorders, 3rd Ed. ('DSM-III'). A total of 117 astronaut applicants underwent this clinical interview as part of a comprehensive medical evaluation during a recent astronaut selection. Of the 117 applicants, 9 (7.7 percent) met DSM-III criteria for a variety of Axis I and Axis II diagnoses, including V-code diagnoses.

Santy, Patricia A.↗
NASA NTRS1998

Quantification of mitral regurgitation by automated cardiac output measurement: experimental and clinical validation

OBJECTIVES: To develop and validate an automated noninvasive method to quantify mitral regurgitation. BACKGROUND: Automated cardiac output measurement (ACM), which integrates digital color Doppler velocities in space and in time, has been validated for the left ventricular (LV) outflow tract but has not been tested for the LV inflow tract or to assess mitral regurgitation (MR). METHODS: First, to validate ACM against a gold standard (ultrasonic flow meter), 8 dogs were studied at 40 different stages of cardiac output (CO). Second, to compare ACM to the LV outflow (ACMa) and inflow (ACMm) tracts, 50 normal volunteers without MR or aortic regurgitation (44+/-5 years, 31 male) were studied. Third, to compare ACM with the standard pulsed Doppler-two-dimensional echocardiographic (PD-2D) method for quantification of MR, 51 patients (61+/-14 years, 30 male) with MR were studied. RESULTS: In the canine studies, CO by ACM (1.32+/-0.3 liter/min, y) and flow meter (1.35+/-0.3 liter/min, x) showed good correlation (r=0.95, y=0.89x+0.11) and agreement (deltaCO(y-x)=0.03+/-0.08 [mean+/-SD] liter/min). In the normal subjects, CO measured by ACMm agreed with CO by ACMa (r=0.90, p < 0.0001, deltaCO=-0.09+/-0.42 liter/min), PD (r=0.87, p < 0.0001, deltaCO=0.12+/-0.49 liter/min) and 2D (r=0.84, p < 0.0001, deltaCO=-0.16+/-0.48 liter/min). In the patients, mitral regurgitant volume (MRV) by ACMm-ACMa agreed with PD-2D (r= 0.88, y=0.88x+6.6, p < 0.0001, deltaMRV=2.68+/-9.7 ml). CONCLUSIONS: We determined that ACM is a feasible new method for quantifying LV outflow and inflow volume to measure MRV and that ACM automatically performs calculations that are equivalent to more time-consuming Doppler and 2D measurements. Additionally, ACM should improve MR quantification in routine clinical practice.

Non-NASA Center↗
NASA NTRSDate not supplied

Exploration Medical Capability Science and Research Overview and Update

The mission of the Exploration Medical Capability (ExMC) Element is to advance medical system design and risk-informed decision making for exploration beyond Low Earth Orbit to promote human health and performance in space. To accomplish this mission, ExMC focuses on several key areas: • Investigating specific risks that are relevant for human exploration spaceflight, including in-flight medical conditions, degraded or toxic medications, and renal stones • Developing medical probabilistic risk analysis tools that are integrated with systems engineering processes to inform the medical system trade space and support the development of robust requirements • Demonstrating and defining requirements for a prototype clinical decision support system • Developing and demonstrating novel medical technologies that will improve future medical capabilities in space This presentation will focus on selected scientific and technical conceptual drivers for the Element and its current and future research risks and gaps while providing an overview of the Element’s progress in 2021 and areas of focus for 2022.

Benjamin Easter↗
NASA NTRS2009

NASA Biomedical Informatics Capabilities and Needs

To improve on-orbit clinical capabilities by developing and providing operational support for intelligent, robust, reliable, and secure, enterprise-wide and comprehensive health care and biomedical informatics systems with increasing levels of autonomy, for use on Earth, low Earth orbit & exploration class missions. Biomedical Informatics is an emerging discipline that has been defined as the study, invention, and implementation of structures and algorithms to improve communication, understanding and management of medical information. The end objective of biomedical informatics is the coalescing of data, knowledge, and the tools necessary to apply that data and knowledge in the decision-making process, at the time and place that a decision needs to be made.

Johnson-Throop, Kathy A.↗