Cosmic Radiation and Cataracts in Airline Pilots

NASA Astrophysics Data System (ADS)

Rafnsson, V.; Olafsdottir, E.; Hrafnkelsson, J.; de Angelis, G.; Sasaki, H.; Arnarson, A.; Jonasson, F.

Nuclear cataracts have been associated with ionising radiation exposure in previous studies. A population based case-control study on airline pilots has been performed to investigate whether employment as a commercial pilot and consequent exposure to cosmic radiation were associated to lens opacification, when adjusted for known risk factors for cataracts. Cases of opacification of the ocular lens were found in surveys among pilots and a random sample of the Icelandic population. Altogether 445 male subjects underwent a detailed eye examination and answered a questionnaire. Information from the airline company on the 79 pilots employment time, annual hours flown per aircraft type, the timetables and the flight profiles made calculation of individual cumulated radiation dose (mSv) possible. Lens opacification were classified and graded according to WHO simplified cataracts grading system using slit lamp. The odds ratio from logistic regression of nuclear cataracts risk among cases and controls was 3.02 (95% CI 1.44 to 6.35) for pilots compared with non-pilots, adjusted for age, smoking and sunbathing habits, whereas that of cortical cataracts risk among cases and controls was lower than unity (non significant) for pilots compared with non-pilots in a logistic regression analysis adjusted for same factors. Length of employment as a pilot and cumulated radiation dose (mSv) were significantly related to the risk of nuclear cataracts. So the association between radiation exposure of pilots and the risk of nuclear cataracts, adjusted for age, smoking and sunbathing habits, indicates that cosmic radiation may be cause of nuclear cataract among commercial pilots.

Safety and Efficacy of Modified Preoperative Lung Nodule Microcoil Localization Without Pleural Marking: A Pilot Study.

PubMed

Kha, Lan-Chau T; Hanneman, Kate; Donahoe, Laura; Chung, Taebong; Pierre, Andrew F; Yasufuku, Kazuhiro; Keshavjee, Shafique; Mayo, John R; Paul, Narinder S; Nguyen, Elsie T

2016-01-01

The purpose of this pilot study was to evaluate the safety and efficacy of preoperative computed tomography (CT)-guided percutaneous microcoil lung nodule localization without pleural marking compared with the established technique with pleural marking. Sixty-three consecutive patients (66.7% female, mean age 61.6±11.4 y) with 64 lung nodules resected between October 2008 and January 2014 were retrospectively evaluated. Of the nodules, 29.7% (n=19) had microcoil deployment with pleural marking (control group) and 70.3% (n=45) had microcoil deployment without pleural marking (pilot group). Clinical, pathologic, and imaging characteristics, radiation dose, CT procedure and operating room time, and complete resection and complication rates were compared between the pilot and control groups. There was no significant difference in nodule size (P=0.552) or distance from the pleural surface (P=0.222) between the pilot and control groups. However, mean procedure duration (53.6±18.3 vs. 72.8±25.3 min, P=0.001) and total effective radiation dose (5.1±2.6 vs. 7.1±4.9 mSv, P=0.039) were significantly lower in the pilot group compared with the control group. CT procedure-related complications (P=0.483) [including pneumothoraces (P=0.769) and pulmonary hemorrhage (P=1.000)], operating room time (P=0.926), complete resection rates (P=0.520), intraoperative complications (P=0.549), and postoperative complications (P=1.000) were similar between the pilot and control groups. Preoperative CT-guided lung nodule microcoil localization performed without visceral pleural marking appears to decrease the CT procedure time and radiation dose while maintaining equivalent complete resection rates and procedural and surgical complications, when compared with microcoil localization performed with pleural marking.

Pilot validation of an individualised pharmacokinetic algorithm for protamine dosing after systemic heparinisation for cardiopulmonary bypass.

PubMed

Miles, Lachlan F; Marchiori, Paolo; Falter, Florian

2017-09-01

This manuscript represents a pilot study assessing the feasibility of a single-compartment, individualised, pharmacokinetic algorithm for protamine dosing after cardiopulmonary bypass. A pilot cohort study in a specialist NHS cardiothoracic hospital targeting patients undergoing elective cardiac surgery using cardiopulmonary bypass. Patients received protamine doses according to a pharmacokinetic algorithm (n = 30) or using an empirical, fixed-dose model (n = 30). Categorical differences between the groups were evaluated using the Chi-squared test or Fisher's exact test. Continuous data was analysed using a paired Student's t-test for parametric data and the paired samples Wilcoxon test for non-parametric data. Patients who had protamine dosing according to the algorithm demonstrated a lower protamine requirement post-bypass relative to empirical management as measured by absolute dose (243 ± 49mg vs. 305 ± 34.7mg; p<0.001) and the heparin to protamine ratio (0.79 ± 0.12 vs. 1.1 ± 0.15; p<0.001). There was no difference in the pre- to post-bypass activated clotting time (ACT) ratio (1.05 ± 0.12 vs. 1.02 ± 0.15; p=0.9). Patients who received protamine according to the algorithm had no significant difference in transfusion requirement (13.3% vs. 30.0%; p=0.21). This study showed that an individualized pharmacokinetic algorithm for the reversal of heparin after cardiopulmonary bypass is feasible in comparison with a fixed dosing strategy and may reduce the protamine requirement following on-pump cardiac surgery.

Efficacy of a Radiation Absorbing Shield in Reducing Dose to the Interventionalist During Peripheral Endovascular Procedures: A Single Centre Pilot Study

DOE Office of Scientific and Technical Information (OSTI.GOV)

Power, S.; Mirza, M.; Thakorlal, A.

PurposeThis prospective pilot study was undertaken to evaluate the feasibility and effectiveness of using a radiation absorbing shield to reduce operator dose from scatter during lower limb endovascular procedures.Materials and MethodsA commercially available bismuth shield system (RADPAD) was used. Sixty consecutive patients undergoing lower limb angioplasty were included. Thirty procedures were performed without the RADPAD (control group) and thirty with the RADPAD (study group). Two separate methods were used to measure dose to a single operator. Thermoluminescent dosimeter (TLD) badges were used to measure hand, eye, and unshielded body dose. A direct dosimeter with digital readout was also used tomore » measure eye and unshielded body dose. To allow for variation between control and study groups, dose per unit time was calculated.ResultsTLD results demonstrated a significant reduction in median body dose per unit time for the study group compared with controls (p = 0.001), corresponding to a mean dose reduction rate of 65 %. Median eye and hand dose per unit time were also reduced in the study group compared with control group, however, this was not statistically significant (p = 0.081 for eye, p = 0.628 for hand). Direct dosimeter readings also showed statistically significant reduction in median unshielded body dose rate for the study group compared with controls (p = 0.037). Eye dose rate was reduced for the study group but this was not statistically significant (p = 0.142).ConclusionInitial results are encouraging. Use of the shield resulted in a statistically significant reduction in unshielded dose to the operator’s body. Measured dose to the eye and hand of operator were also reduced but did not reach statistical significance in this pilot study.« less

Marijuana and actual driving performance

DOT National Transportation Integrated Search

1993-11-01

This report concerns the effects of marijuana smoking on actual driving performance. It presents the results of one pilot and three actual driving studies. The pilot study's major purpose was to establish the THC dose current marijuana users smoke to...

Assessment of the unattached fraction of indoor radon progeny and its contribution to dose: a pilot study in China.

PubMed

Guo, Qiuju; Zhang, Lei; Guo, Lu

2012-12-01

The unattached fraction of radon progeny (f(p)) is one of the most important factors for accurate evaluation of the effective dose from a unit of radon exposure, and it may vary greatly in different environments. For precise evaluation of the indoor radon exposure dose and the influence of unattached radon progeny, a pilot survey of f(p) in different environments was carried out in China with a portable and integrating monitor. The dose conversion factors for radon progeny are calculated with LUDEP(®) code, and the dose contributions from the unattached and the attached radon progenies were simultaneously evaluated based on the results of field measurements. The results show that even though the concentrations of radon progeny vary significantly among different indoor environments, the variations of f(p) seem relatively small (9.3-16.9%). The dose contribution from unattached radon progeny is generally larger (30.2-46.2%) in an indoor environment.

Cognitive Performance Effects of Bilastine 20 mg During 6 Hours at 8000 ft Cabin Altitude.

PubMed

Valk, Pierre J L; Simons, Ries; Jetten, Andrea M; Valiente, Román; Labeaga, Luis

2016-07-01

Bilastine is a new oral, second generation antihistamine used in the symptomatic treatment of allergic rhinoconjunctivitis and urticaria. It is considered a nonsedating antihistamine and might be recommended for use in pilots, pending research on the effects on flying-related performance under hypobaric conditions that prevail in an airliner. We assessed the effects of a single dose of bilastine 20 mg on alertness and complex task performance of healthy volunteers in a hypobaric chamber at 75.2 kPa (8000 ft/2438 m cabin altitude). In a randomized, double-blind, crossover study, 24 volunteers received a single dose of bilastine 20 mg, hydroxyzine 50 mg (active control), and placebo. Using the Vigilance and Tracking Task, Multi-Attribute Task Battery, and Stanford Sleepiness Scale, assessments were made before and up to 6 h after intake of the study medication. Bilastine 20 mg had no impairing effects on sleepiness levels, vigilance, or complex task performance for up to 6 h post-dose. Hydroxyzine 50 mg (active control) was associated with significant sleepiness and impaired performance across this time period, confirming the sensitivity of the tests. Bilastine 20 mg did not cause sleepiness or impaired performance on tasks related to flying. It is anticipated that a single dose of bilastine 20 mg will not affect flying performance. Bilastine may provide a safe therapeutic alternative for pilots suffering from allergic rhinitis or urticaria. Our findings might also have implications for the treatment of allergic disorders of personnel involved in other safety-sensitive jobs. Valk PJL, Simons R, Jetten AM, Valiente R, Labeaga L. Cognitive performance effects of bilastine 20 mg during 6 hours at 8000 ft cabin altitude. Aerosp Med Hum Perform. 2016; 87(7):622-627.

Final environmental impact statement. Waste Isolation Pilot Plant

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1980-10-01

This volume contains the appendices for the Final Environmental Impact Statement for the Waste Isolation Pilot Plant (WIPP). Alternative geologic environs are considered. Salt, crystalline rock, argillaceous rock, and tuff are discussed. Studies on alternate geologic regions for the siting of WIPP are reviewed. President Carter's message to Congress on the management of radioactive wastes and the findings and recommendations of the interagency review group on nuclear waste management are included. Selection criteria for the WIPP site including geologic, hydrologic, tectonic, physicochemical compatability, and socio-economic factors are presented. A description of the waste types and the waste processing procedures aremore » given. Methods used to calculate radiation doses from radionuclide releases during operation are presented. A complete description of the Los Medanos site, including archaeological and historic aspects is included. Environmental monitoring programs and long-term safety analysis program are described. (DMC)« less

Process evaluation of a tailored mobile health intervention aiming to reduce fatigue in airline pilots.

PubMed

van Drongelen, Alwin; Boot, Cécile R L; Hlobil, Hynek; Smid, Tjabe; van der Beek, Allard J

2016-08-26

MORE Energy is a mobile health intervention which aims to reduce fatigue and improve health in airline pilots. The primary objective of this process evaluation was to assess the reach, dose delivered, compliance, fidelity, barriers and facilitators, and satisfaction of the intervention. The second objective was to investigate the associations of adherence to the intervention with compliance and with participant satisfaction. Thirdly, we investigated differences between the subgroups within the target population. The intervention consisted of a smartphone application, supported by a website. It provided advice on optimal light exposure, sleep, nutrition, and physical activity, tailored to flight and personal characteristics. The reach of the intervention was determined by comparing the intervention group participants and the airline pilots who did not participate. The dose delivered was defined as the total number of participants that was sent an instruction email. Objective compliance was measured through the Control Management System of the application. To determine the fidelity, an extensive log was kept throughout the intervention period. Subjective compliance, satisfaction, barriers, facilitators, and adherence were assessed using online questionnaires. Associations between the extent to which the participants applied the advice in daily life (adherence), compliance, and satisfaction were analysed as well. Finally, outcomes of participants of different age groups and haul types were compared. A total of 2222 pilots were made aware of the study. From this group, 502 pilots met the inclusion criteria and did agree to participate. The reach of the study proved to be 22 % and the dose delivered was 99 %. The included pilots were randomized into the intervention group (n = 251) or the control group (n = 251). Of the intervention group participants, 81 % consulted any advice, while 17 % did this during four weeks or more. Fidelity was 67 %. The participants rated the intervention with a 6.4 (SD 1.6). Adherence was not associated with compliance, but was associated with satisfaction (p ≤ 0.001). Pilots of 35 to 45 year old were significantly more interested in advice regarding physical activity than their colleagues, and short-haul pilots were more interested in advice regarding nutrition compared to long-haul pilots. The MORE Energy intervention was well received, resulting in an adequate reach and a high dose delivered. The compliance and satisfaction scores indicate that engagement and functionality should be enhanced, and the content and applicability of the advices should be improved to appeal all subgroups of the target population. Nederlands Trial Register NTR2722 . Registered 27 January 2011.

Physiological recording from pilots operating an aircraft simulator.

DOT National Transportation Integrated Search

1964-09-01

The questions to be answered were reduced to the following : (1) to determine whether or not theraputic doses of two common drugs, a tranquilizer and an antihistamine, cause decrements in the operating proficiency of pilots, and (2) do those drugs wh...

The effect of grape seed extract on estrogen levels of postmenopausal women: a pilot study.

PubMed

Wahner-Roedler, Dietlind L; Bauer, Brent A; Loehrer, Laura L; Cha, Stephen S; Hoskin, Tanya L; Olson, Janet E

2014-06-01

The role of estrogens in breast cancer (BC) development is widely accepted, leading to the development of selective estrogen receptor modulators and aromatase inhibitors for BC treatment and prevention. However, because of potential adverse effects, healthy women with high risk of BC are hesitant to take them. Preliminary evidence from animal studies shows that grapes may have an aromatase-inhibiting effect, decreasing estrogen synthesis and increasing androgen precursors. We conducted a randomized, double-blind, dose-finding early-phase trial on the effect of grape seed extract (GSE) on estrogen levels. Postmenopausal women who met study inclusion criteria (N = 46) were randomly assigned to daily GSE at a dose of 200, 400, 600, or 800 mg for 12 weeks. Primary outcome was change in plasma levels of estrogen conjugates from baseline to 12 weeks posttreatment. Thirty-nine participants (84.8%) completed the study. GSE in the 4 daily doses did not significantly decrease estrogen or increase androgen precursors.

[Radiation situation prognosis for deep space: reactions of water and living systems to chronic low-dose ionizing irradiation].

PubMed

Ushakov, I B; Tsetlin, V V; Moisa, S S

2013-01-01

The authors review the findings of researches into the effects of low-dose ionizing irradiation on diverse biological objects (embryonic Japanese quails, Aspergillus niger, Spirostomum ambiguum Ehrbg., mesenchymal stem cells from mouse marrow, dry higher plants seeds, blood lymphocytes from pilots and cosmonauts). Model experiments with chronic exposure to ionizing radiation doses comparable with the measurements inside orbital vehicles and estimations for trips through the interplanetary space resulted in morphological disorders (embryonic Japanese quails, Aspergillus niger), radiation hormesis (Aspergillus niger, MSCs from mouse marrow), increase in the seed germination rate, inhibition of Spirostomum spontaneous activity, DNA damages, chromosomal aberrations, and increase of the blood lymphocytes reactivity to additional radiation loading. These facts give grounds to assume that the crucial factor in the radiation outcomes is changes in liquid medium. In other words, during extended orbiting within the magnetosphere region and interplanetary missions ionizing radiation affects primarily liquids of organism and, secondarily, its morphofunctional structures.

Intermittent preventive treatment of malaria during pregnancy in central Mozambique.

PubMed

Brentlinger, Paula E; Dgedge, Martinho; Correia, Maria Ana Chadreque; Rojas, Ana Judith Blanco; Saúte, Francisco; Gimbel-Sherr, Kenneth H; Stubbs, Benjamin A; Mercer, Mary Anne; Gloyd, Stephen

2007-11-01

New WHO strategies for control of malaria in pregnancy (MiP) recommend intermittent preventive treatment (IPTp), bednet use and improved case management. A pilot MiP programme in Mozambique was designed to determine requirements for scale-up. The Ministry of Health worked with a nongovernmental organization and an academic institution to establish and monitor a pilot programme in two impoverished malaria-endemic districts. Implementing the pilot programme required provision of additional sulfadoxine-pyrimethamine (SP), materials for directly observed SP administration, bednets and a modified antenatal card. National-level formulary restrictions on SP needed to be waived. The original protocol required modification because imprecision in estimation of gestational age led to missed SP doses. Multiple incompatibilities with other health initiatives (including programmes for control of syphilis, anaemia and HIV) were discovered and overcome. Key outputs and impacts were measured; 92.5% of 7911 women received at least 1 dose of SP, with the mean number of SP doses received being 2.2. At the second antenatal visit, 13.5% of women used bednets. In subgroups (1167 for laboratory analyses; 2600 births), SP use was significantly associated with higher haemoglobin levels (10.9 g/dL if 3 doses, 10.3 if none), less malaria parasitaemia (prevalence 7.5% if 3 doses, 39.3% if none), and fewer low-birth-weight infants (7.3% if 3 doses, 12.5% if none). National-level scale-up will require attention to staffing, supplies, bednet availability, drug policy, gestational-age estimation and harmonization of vertical initiatives.

Evaluation of the antihyperalgesic effect of tapentadol in two human evoked pain models - the TapCapMentho pilot trial.

PubMed

Förster, M; Helfert, S; Dierschke, R; Großkopf, M; Hüllemann, P; Keller, T; Baron, R; Binder, A

2016-09-01

Tapentadol is effective in the treatment of neuropathic and nociceptive pain and in acute and chronic pain conditions; two mechanisms combining opioid µ-receptor agonism and noradrenergic reuptake inhibition underlie its analgesic effect. With this single-center, placebo-controlled, double-blind, cross-over pilot-study, we investigated the antihyperalgesic effect of a single oral dose of 100 mg immediate-release tapentadol on thermal and mechanical hyperalgesia in two human models (i.e. 0.6 % topical capsaicin and 40% topical menthol) of evoked neuropathic pain signs in healthy volunteers. No significant differences regarding experimentally induced heat or cold and mechanical (pinprick) hyperalgesia, as assessed by quantitative sensory testing, could be observed between a single dose of drug and placebo (thermal pain thresholds p>0.4, mechanical pain sensitivity p>0.1). Only few mild side effects of tapentadol were reported. The discrepancy between pain models using healthy volunteers and drug trials under real acute and chronic pain conditions in patients as well as methodological aspects may have contributed to this result. The impact of these findings questions the general use of pain models as predictors for early decision making during drug development. The study was registered in ClinicalTrials.gov (NCT01615510).

F-18-FDG-PET Confined Radiotherapy of Locally Advanced NSCLC With Concomitant Chemotherapy: Results of the PET-PLAN Pilot Trial

DOE Office of Scientific and Technical Information (OSTI.GOV)

Fleckenstein, Jochen; Hellwig, Dirk; Kremp, Stephanie

2011-11-15

Purpose: The integration of fluoro-deoxy-D-glucose positron emission tomography (FDG-PET) in the process of radiotherapy (RT) planning of locally advanced non-small-cell lung cancer (NSCLC) may improve diagnostic accuracy and minimize interobserver variability compared with target volume definition solely based on computed tomography. Furthermore, irradiating only FDG-PET-positive findings and omitting elective nodal regions may allow dose escalation by treating smaller volumes. The aim of this prospective pilot trial was to evaluate the therapeutic safety of FDG-PET-based RT treatment planning with an autocontour-derived delineation of the primary tumor. Methods and Materials: Eligible patients had Stages II-III inoperable NSCLC, and simultaneous, platinum-based radiochemotherapy wasmore » indicated. FDG-PET and computed tomography acquisitions in RT treatment planning position were coregistered. The clinical target volume (CTV) included the FDG-PET-defined primary tumor, which was autodelineated with a source-to-background algorithm, plus FDG-PET-positive lymph node stations. Limited by dose restrictions for normal tissues, prescribed total doses were in the range of 66.6 to 73.8 Gy. The primary endpoint was the rate of out-of-field isolated nodal recurrences (INR). Results: As per intent to treat, 32 patients received radiochemotherapy. In 15 of these patients, dose escalation above 66.6 Gy was achieved. No Grade 4 toxicities occurred. After a median follow-up time of 27.2 months, the estimated median survival time was 19.3 months. During the observation period, one INR was observed in 23 evaluable patients. Conclusions: FDG-PET-confined target volume definition in radiochemotherapy of NSCLC, based on a contrast-oriented source-to-background algorithm, was associated with a low risk of INR. It might provide improved tumor control because of dose escalation.« less

The Ramazzini Institute 13-week pilot study on glyphosate and Roundup administered at human-equivalent dose to Sprague Dawley rats: effects on the microbiome.

PubMed

Mao, Qixing; Manservisi, Fabiana; Panzacchi, Simona; Mandrioli, Daniele; Menghetti, Ilaria; Vornoli, Andrea; Bua, Luciano; Falcioni, Laura; Lesseur, Corina; Chen, Jia; Belpoggi, Fiorella; Hu, Jianzhong

2018-05-29

Glyphosate-based herbicides (GBHs) are broad-spectrum herbicides that act on the shikimate pathway in bacteria, fungi, and plants. The possible effects of GBHs on human health are the subject of an intense public debate for both its potential carcinogenic and non-carcinogenic effects, including its effects on microbiome. The present pilot study examines whether exposure to GBHs at doses of glyphosate considered to be "safe" (the US Acceptable Daily Intake - ADI - of 1.75 mg/kg bw/day), starting from in utero, may modify the composition of gut microbiome in Sprague Dawley (SD) rats. Glyphosate alone and Roundup, a commercial brand of GBHs, were administered in drinking water at doses comparable to the US glyphosate ADI (1.75 mg/kg bw/day) to F0 dams starting from the gestational day (GD) 6 up to postnatal day (PND) 125. Animal feces were collected at multiple time points from both F0 dams and F1 pups. The gut microbiota of 433 fecal samples were profiled at V3-V4 region of 16S ribosomal RNA gene and further taxonomically assigned and assessed for diversity analysis. We tested the effect of exposure on overall microbiome diversity using PERMANOVA and on individual taxa by LEfSe analysis. Microbiome profiling revealed that low-dose exposure to Roundup and glyphosate resulted in significant and distinctive changes in overall bacterial composition in F1 pups only. Specifically, at PND31, corresponding to pre-pubertal age in humans, relative abundance for Bacteriodetes (Prevotella) was increased while the Firmicutes (Lactobacillus) was reduced in both Roundup and glyphosate exposed F1 pups compared to controls. This study provides initial evidence that exposures to commonly used GBHs, at doses considered safe, are capable of modifying the gut microbiota in early development, particularly before the onset of puberty. These findings warrant future studies on potential health effects of GBHs in early development such as childhood.

Making pharmacogenomic-based prescribing alerts more effective: A scenario-based pilot study with physicians.

PubMed

Overby, Casey Lynnette; Devine, Emily Beth; Abernethy, Neil; McCune, Jeannine S; Tarczy-Hornoch, Peter

2015-06-01

To facilitate personalized drug dosing (PDD), this pilot study explored the communication effectiveness and clinical impact of using a prototype clinical decision support (CDS) system embedded in an electronic health record (EHR) to deliver pharmacogenomic (PGx) information to physicians. We employed a conceptual framework and measurement model to access the impact of physician characteristics (previous experience, awareness, relative advantage, perceived usefulness), technology characteristics (methods of implementation-semi-active/active, actionability-low/high) and a task characteristic (drug prescribed) on communication effectiveness (usefulness, confidence in prescribing decision), and clinical impact (uptake, prescribing intent, change in drug dosing). Physicians performed prescribing tasks using five simulated clinical case scenarios, presented in random order within the prototype PGx-CDS system. Twenty-two physicians completed the study. The proportion of physicians that saw a relative advantage to using PGx-CDS was 83% at the start and 94% at the conclusion of our study. Physicians used semi-active alerts 74-88% of the time. There was no association between previous experience with, awareness of, and belief in a relative advantage of using PGx-CDS and improved uptake. The proportion of physicians reporting confidence in their prescribing decisions decreased significantly after using the prototype PGx-CDS system (p=0.02). Despite decreases in confidence, physicians perceived a relative advantage to using PGx-CDS, viewed semi-active alerts on most occasions, and more frequently changed doses toward doses supported by published evidence. Specifically, sixty-five percent of physicians reduced their dosing, significantly for capecitabine (p=0.002) and mercaptopurine/thioguanine (p=0.03). These findings suggest a need to improve our prototype such that PGx CDS content is more useful and delivered in a way that improves physician's confidence in their prescribing decisions. The greatest increases in communication effectiveness and clinical impact of PGx-CDS are likely to be realized through continued focus on content, content delivery, and tailoring to physician characteristics. Copyright © 2015 Elsevier Inc. All rights reserved.

A Pilot Study of the Impact of Double-Dose Robust Vocabulary Instruction on Children's Vocabulary Growth

ERIC Educational Resources Information Center

Arthur, Ann M.; Davis, Dawn L.

2016-01-01

Double-dose instruction, in which instructional lessons are supplemented to provide additional instructional time, is a mechanism used in some schools for boosting outcomes in certain academic areas. The purpose of this study was to examine the effects of double-dose vocabulary instruction, relative to single-dose and business-as-usual control…

Comparison of the effective dose rate to aircrew members using hybrid computational phantoms in standing and sitting postures.

PubMed

Alves, M C; Galeano, D C; Santos, W S; Lee, Choonsik; Bolch, Wesley E; Hunt, John G; da Silva, A X; Carvalho, A B

2016-12-01

Aircraft crew members are occupationally exposed to considerable levels of cosmic radiation at flight altitudes. Since aircrew (pilots and passengers) are in the sitting posture for most of the time during flight, and up to now there has been no data on the effective dose rate calculated for aircrew dosimetry in flight altitude using a sitting phantom, we therefore calculated the effective dose rate using a phantom in the sitting and standing postures in order to compare the influence of the posture on the radiation protection of aircrew members. We found that although the better description of the posture in which the aircrews are exposed, the results of the effective dose rate calculated with the phantom in the sitting posture were very similar to the results of the phantom in the standing posture. In fact we observed only a 1% difference. These findings indicate the adequacy of the use of dose conversion coefficients for the phantom in the standing posture in aircrew dosimetry. We also validated our results comparing the effective dose rate obtained using the standing phantom with values reported in the literature. It was observed that the results presented in this study are in good agreement with other authors (the differences are below 30%) who have measured and calculated effective dose rates using different phantoms.

Dose rate prediction methodology for remote handled transuranic waste workers at the waste isolation pilot plant.

PubMed

Hayes, Robert

2002-10-01

An approach is described for estimating future dose rates to Waste Isolation Pilot Plant workers processing remote handled transuranic waste. The waste streams will come from the entire U.S. Department of Energy complex and can take on virtually any form found from the processing sequences for defense-related production, radiochemistry, activation and related work. For this reason, the average waste matrix from all generator sites is used to estimate the average radiation fields over the facility lifetime. Innovative new techniques were applied to estimate expected radiation fields. Non-linear curve fitting techniques were used to predict exposure rate profiles from cylindrical sources using closed form equations for lines and disks. This information becomes the basis for Safety Analysis Report dose rate estimates and for present and future ALARA design reviews when attempts are made to reduce worker doses.

Study protocol for a phase II dose evaluation randomized controlled trial of cholecalciferol in critically ill children with vitamin D deficiency (VITdAL-PICU study).

PubMed

McNally, Dayre; Amrein, Karin; O'Hearn, Katharine; Fergusson, Dean; Geier, Pavel; Henderson, Matt; Khamessan, Ali; Lawson, Margaret L; McIntyre, Lauralyn; Redpath, Stephanie; Weiler, Hope A; Menon, Kusum

2017-01-01

Clinical research has recently demonstrated that vitamin D deficiency (VDD) is highly prevalent in the pediatric intensive care unit (PICU) and associated with worse clinical course. Multiple adult ICU trials have suggested that optimization of vitamin D status through high-dose supplementation may reduce mortality and improve other clinically relevant outcomes; however, there have been no trials of rapid normalization in the PICU setting. The objective of this study is to evaluate the safety and efficacy of an enteral weight-based cholecalciferol loading dose regimen in critically ill children with VDD. The VITdAL-PICU pilot study is designed as a multicenter placebo-controlled phase II dose evaluation pilot randomized controlled trial. We aim to randomize 67 VDD critically ill children using a 2:1 randomization schema to receive loading dose enteral cholecalciferol (10,000 IU/kg, maximum of 400,000 IU) or a placebo solution. Participants, caregivers and outcome assessors will be blinded to allocation. Eligibility criteria include ICU patient, aged 37 weeks to 18 years, expected ICU length of stay more than 48 h, anticipated access to bloodwork at 7 days, and VDD (blood total 25 hydroxyvitamin D < 50 nmol/L). The primary objective is to determine whether the dosing protocol normalizes vitamin D status, defined as a blood total 25(OH)D concentration above 75 nmol/L. Secondary objectives include an examination of the safety of the dosing regimen (e.g. hypercalcemia, hypercalciuria, nephrocalcinosis), measures of vitamin D axis function (e.g. calcitriol levels, immune function), and protocol feasibility (eligibility criteria, protocol deviations, blinding). Despite significant observational literature suggesting VDD to be a modifiable risk factor in the PICU setting, there is no robust clinical trial evidence evaluating the benefits of rapid normalization. This phase II clinical trial will evaluate an innovative weight-based dosing regimen intended to rapidly and safely normalize vitamin D levels in critically ill children. Study findings will be used to inform the design of a multicenter phase III trial evaluating the clinical and economic benefits to rapid normalization. Recruitment for this trial was initiated in January 2016 and is expected to continue until November 30, 2017. Clinicaltrials.gov NCT02452762.

Development of an objective dose distribution analysis method for OSL dating and pilot studies for planetary applications

NASA Astrophysics Data System (ADS)

Lepper, Kenneth Errol

Scope and method of study. Part I: In its simplest expression a luminescence age is the natural absorbed radiation dose (De) divided by the in-situ dose rate. The experimental techniques of Optically Stimulated Luminescence (OSL) dating have evolved to the point were hundreds of Des, and therefore depositional ages can be quickly and conveniently determined for a single sediment sample. The first major objective of this research was to develop an objective analysis method for analyzing dose distribution data and selecting an age-representative dose (Dp). The analytical method was developed based on dose data sets collected from 3 eolian and 3 fluvial sediment samples from Central Oklahoma. Findings and conclusions. Part I: An objective method of presenting the dose distribution data, and a mathematically rigorous means of determining the Dp, as well as a statistically meaningful definition of the uncertainty in Dp have been proposed. The concept of experimental error deconvolution was introduced. In addition a set of distribution shape parameters to facilitate comparison among samples have been defined. These analytical techniques hold the potential to greatly enhance the accuracy and utility of OSL dating for young fluvial sediments. Scope and method of study. Part II: The second major objective of this research was to propose the application of luminescence dating to sediments on Mars. A set of fundamental luminescence dating properties was evaluated for a martian surface materials analog and a polar deposit contextual analog. Findings and conclusions. Part II: The luminescence signals measured from the analogs were found to have a wide dynamic dose response range with no unusual or prohibitive short-term instabilities and were readily reset by exposure to sunlight. These properties form a stable base for continued investigations toward the development of luminescence dating instruments and procedures for Mars.

REMOVAL OF CRYPTOSPORIDIUM AND GIARDIA THROUGH CONVENTIONAL WATER TREATMENT AND DIRECT FILTRATION

EPA Science Inventory

Pilot- and full-scale evaluations of Giardia and Cryptosporidium cyst removal through direction filtration and conventional water treatment were conducted by the Utah Department of Environmental Quality. Cysts were seeded continuously in a step dose at a 0.5 gpm pilot plant and i...

Occupational cosmic radiation exposure in Portuguese airline pilots: study of a possible correlation with oxidative biological markers.

PubMed

Silva, Rodrigo; Folgosa, Filipe; Soares, Paulo; Pereira, Alice S; Garcia, Raquel; Gestal-Otero, Juan Jesus; Tavares, Pedro; Gomes da Silva, Marco D R

2013-05-01

Several studies have sought to understand the health effects of occupational exposure to cosmic radiation. However, only few biologic markers or associations with disease outcomes have so far been identified. In the present study, 22 long- and 26 medium-haul male Portuguese airline pilots and 36 factory workers who did not fly regularly were investigated. The two groups were comparable in age and diet, were non-smokers, never treated with ionizing radiation and other factors. Cosmic radiation exposure in pilots was quantified based on direct monitoring of 51 flights within Europe, and from Europe to North and South America, and to Africa. Indirect dose estimates in pilots were performed based on the SIEVERT (Système informatisé d'évaluation par vol de l'exposition au rayonnement cosmique dans les transports aériens) software for 6,039 medium- and 1,366 long-haul flights. Medium-haul pilots had a higher cosmic radiation dose rate than long-haul pilots, that is, 3.3 ± 0.2 μSv/h and 2.7 ± 0.3 μSv/h, respectively. Biological tests for oxidative stress on blood and urine, as appropriate, at two time periods separated by 1 year, included measurements of antioxidant capacity, total protein, ferritin, hemoglobin, creatinine and 8-hydroxy-2-deoxyguanosine (8OHdG). Principal components analysis was used to discriminate between the exposed and unexposed groups based on all the biological tests. According to this analysis, creatinine and 8OHdG levels were different for the pilots and the unexposed group, but no distinctions could be made among the medium- and the long-haul pilots. While hemoglobin levels seem to be comparable between the studied groups, they were directly correlated with ferritin values, which were lower for the airline pilots.

Determination of uranium and thorium using gamma spectrometry: a pilot study

NASA Astrophysics Data System (ADS)

Olivares, D. M. M.; Koch, E. S.; Guevara, M. V. M.; Velasco, F. G.

2018-03-01

This paper presents the results of a pilot experiment aimed at standardizing procedures for the CPqCTR/UESC Gamma Spectrometry Laboratory (LEG) for the quantification of natural radioactive elements in solid environmental samples. The concentrations of 238U, 232Th and 40K in two sediment matrix belonging to the Caetité region were determined, by using the absolute method with uncertainties about 5%. The results were obtained using gamma spectrometry with a high-resolution p-type HPGe detector. As a closure, the absorbed dose, radium equivalent activity and the annual effective dose were calculated.

The atypical excretion profile of meldonium: Comparison of urinary detection windows after single- and multiple-dose application in healthy volunteers.

PubMed

Görgens, Christian; Guddat, Sven; Bosse, Christina; Geyer, Hans; Pop, Valentin; Schänzer, Wilhelm; Thevis, Mario

2017-05-10

Following a one-year monitoring program providing unequivocal analytical evidence for a high prevalence in international elite sports, meldonium has been included in the World Anti-Doping Agency's (WADA) list of prohibited substances that came into effect on 1 January 2016. Despite of the polar and hydrophilic nature of the molecule, an unusual long detection window was observed in pilot elimination studies. Consequently, in the present study, urinary excretion profiles after single-dose (5 volunteers, 1×500mg) and multiple-dose oral application (5 volunteers; 2×500mg/day for 6days) were determined in order to facilitate the result management concerning meldonium findings in doping controls. Particularly the option to differentiate between recent use and tapering concentrations was studied. Urinary meldonium concentrations were determined using an analytical approach based on hydrophilic interaction liquid chromatography and high resolution tandem mass spectrometry. The study corroborates the hypothesis of a non-linear, dose-depended and biphasic excretion profile after oral application of meldonium and demonstrates that urinary detection windows are of considerable extent with up to 65 and 117days (concentrations>LOQ of 10ng/mL) following single- and multiple-dose applications, respectively. Copyright © 2017 Elsevier B.V. All rights reserved.

High thresholds for avoidance of sonar by free-ranging long-finned pilot whales (Globicephala melas).

PubMed

Antunes, R; Kvadsheim, P H; Lam, F P A; Tyack, P L; Thomas, L; Wensveen, P J; Miller, P J O

2014-06-15

The potential effects of exposing marine mammals to military sonar is a current concern. Dose-response relationships are useful for predicting potential environmental impacts of specific operations. To reveal behavioral response thresholds of exposure to sonar, we conducted 18 exposure/control approaches to 6 long-finned pilot whales. Source level and proximity of sonar transmitting one of two frequency bands (1-2 kHz and 6-7 kHz) were increased during exposure sessions. The 2-dimensional movement tracks were analyzed using a changepoint method to identify the avoidance response thresholds which were used to estimate dose-response relationships. No support for an effect of sonar frequency or previous exposures on the probability of response was found. Estimated response thresholds at which 50% of population show avoidance (SPLmax=170 dB re 1 μPa, SELcum=173 dB re 1 μPa(2) s) were higher than previously found for other cetaceans. The US Navy currently uses a generic dose-response relationship to predict the responses of cetaceans to naval active sonar, which has been found to underestimate behavioural impacts on killer whales and beaked whales. The navy curve appears to match more closely our results with long-finned pilot whales, though it might underestimate the probability of avoidance for pilot-whales at long distances from sonar sources. Copyright © 2014 Elsevier Ltd. All rights reserved.

Inhibition of ovulation by administration of estetrol in combination with drospirenone or levonorgestrel: Results of a phase II dose-finding pilot study.

PubMed

Duijkers, Ingrid J M; Klipping, Christine; Zimmerman, Yvette; Appels, Nicole; Jost, Maud; Maillard, Catherine; Mawet, Marie; Foidart, Jean-Michel; Coelingh Bennink, Herjan J T

2015-01-01

The aim of the study was to evaluate the efficacy of different dosages of estetrol (E4) combined with one of two progestins in suppressing the pituitary-ovarian axis and ovulation in healthy premenopausal women. This was an open, parallel, phase II, dose-finding, pilot study performed in healthy women aged 18 to 35 years with a documented ovulatory cycle before treatment. For three consecutive cycles in a 24/4-day regimen, participants received 5 mg or 10 mg E4/3 mg drospirenone (DRSP); 5 mg, 10 mg or 20 mg E4/150 μg levonorgestrel; or 20 μg ethinylestradiol (EE)/3 mg DRSP as comparator. Pituitary-ovarian axis activity and the occurrence of ovulation were evaluated by monitoring follicular size, serum levels of follicle-stimulating hormone, luteinising hormone, estradiol and progesterone during treatment cycles 1 and 3. Endometrial thickness was evaluated throughout the trial, and the return of ovulation was evaluated after the last intake of medication. A total of 109 women were included in the trial. No ovulation occurred in any treatment group. Ovarian activity inhibition seemed proportional to the E4 dosage: the highest suppression was observed in the 20 mg E4 group and was very similar to that observed with EE/DRSP. Endometrial thickness was suppressed to the same extent in all groups. Post-treatment ovulation occurred in all participants between 17 and 21 days after the last active treatment. The study combinations were well tolerated and safe. Combined with a progestin, E4 adequately suppresses ovarian activity, particularly when given at a dosage above 10 mg/day.

Sublingual Buprenorphine/Naloxone for Chronic Pain in At-Risk Patients: Development and Pilot Test of a Clinical Protocol

PubMed Central

Rosenblum, Andrew; Cruciani, Ricardo A.; Strain, Eric C; Cleland, Charles M.; Joseph, Herman; Magura, Stephen; Marsch, Lisa A; McNicholas, Laura F; Savage, Seddon R; Sundaram, Arun; Portenoy, Russell K.

2013-01-01

Objective Sublingual buprenorphine/naloxone (Bup/Nx) is approved for addiction treatment and may be useful for pain management, particularly in opioid-treated pain patients with nonadherence behaviors. The transition of opioid-treated pain patients to buprenorphine carries the risk of precipitated withdrawal and increased pain. This study convened pain and addiction specialists to develop and pilot a clinical protocol for safe transitioning to Bup/Nx. Design The protocol was revised three times based on outside expert review and pilot study observations. The pilot was conducted with a prospective cohort of 12 patients with moderate to severe chronic pain, who were receiving long-term opioid therapy with any full μ-agonist drug, and had exhibited one or more aberrant drug-related behaviors. Patients were followed up for 3 to 6 months with the expectation that they would experience few adverse events and report lower pain severity. Results The three patients on the highest baseline opioid dose (equivalent to 303–450 mg of oral morphine) and the three on the lowest doses (≤20 mg) had early adverse events (AEs) when switched to Bup/Nx and did not complete the trial. Of the remaining six, one withdrew due to AEs; one responded well, then withdrew; and four completed a three-month trial. A mixed effects model controlling for dropouts found that average and worst pain significantly decreased after the switch to Bup/Nx (both p < .01). Conclusion Based on this experience, the protocol recommends Bup/Nx for pain only when baseline opioid doses are within bounds that reduce AEs at transition and incorporates dose flexibility to further reduce risks. This protocol warrants further testing. PMID:23264315

Cholera Vaccination in Urban Haiti

PubMed Central

Rouzier, Vanessa; Severe, Karine; Juste, Marc Antoine Jean; Peck, Mireille; Perodin, Christian; Severe, Patrice; Deschamps, Marie Marcelle; Verdier, Rose Irene; Prince, Sabine; Francois, Jeannot; Cadet, Jean Ronald; Guillaume, Florence D.; Wright, Peter F.; Pape, Jean W.

2013-01-01

Successful and sustained efforts have been made to curtail the major cholera epidemic that occurred in Haiti in 2010 with the promotion of hygiene and sanitation measures, training of health personnel and establishment of treatment centers nationwide. Oral cholera vaccine (OCV) was introduced by the Haitian Ministry of Health as a pilot project in urban and rural areas. This paper reports the successful OCV pilot project led by GHESKIO Centers in the urban slums of Port-au-Prince where 52,357 persons received dose 1 and 90.8% received dose 2; estimated coverage of the at-risk community was 75%. This pilot study demonstrated the effort, community mobilization, and organizational capacity necessary to achieve these results in a challenging setting. The OCV intervention paved the way for the recent launching of a national cholera vaccination program integrated in a long-term ambitious and comprehensive plan to address Haiti's critical need in water security and sanitation. PMID:24106194

New mechanistically based model for predicting reduction of biosolids waste by ozonation of return activated sludge.

PubMed

Isazadeh, Siavash; Feng, Min; Urbina Rivas, Luis Enrique; Frigon, Dominic

2014-04-15

Two pilot-scale activated sludge reactors were operated for 98 days to provide the necessary data to develop and validate a new mathematical model predicting the reduction of biosolids production by ozonation of the return activated sludge (RAS). Three ozone doses were tested during the study. In addition to the pilot-scale study, laboratory-scale experiments were conducted with mixed liquor suspended solids and with pure cultures to parameterize the biomass inactivation process during exposure to ozone. The experiments revealed that biomass inactivation occurred even at the lowest doses, but that it was not associated with extensive COD solubilization. For validation, the model was used to simulate the temporal dynamics of the pilot-scale operational data. Increasing the description accuracy of the inactivation process improved the precision of the model in predicting the operational data. Copyright © 2014 Elsevier B.V. All rights reserved.

Incidence of cancer among Nordic airline pilots over five decades: occupational cohort study

PubMed Central

Pukkala, Eero; Aspholm, Rafael; Auvinen, Anssi; Eliasch, Harald; Gundestrup, Maryanne; Haldorsen, Tor; Hammar, Niklas; Hrafnkelsson, Jón; Kyyrönen, Pentti; Linnersjö, Anette; Rafnsson, Vilhjálmur; Storm, Hans; Tveten, Ulf

2002-01-01

Objective To assess the incidence of cancer among male airline pilots in the Nordic countries, with special reference to risk related to cosmic radiation. Design Retrospective cohort study, with follow up of cancer incidence through the national cancer registries. Setting Denmark, Finland, Iceland, Norway, and Sweden. Participants 10 032 male airline pilots, with an average follow up of 17 years. Main outcome measures Standardised incidence ratios, with expected numbers based on national cancer incidence rates; dose-response analysis using Poisson regression. Results 466 cases of cancer were diagnosed compared with 456 expected. The only significantly increased standardised incidence ratios were for skin cancer: melanoma 2.3 (95% confidence interval 1.7 to 3.0), non-melanoma 2.1 (1.7 to 2.8), basal cell carcinoma 2.5 (1.9 to 3.2). The relative risk of skin cancers increased with the estimated radiation dose. The relative risk of prostate cancer increased with increasing number of flight hours in long distance aircraft. Conclusions This study does not indicate a marked increase in cancer risk attributable to cosmic radiation, although some influence of cosmic radiation on skin cancer cannot be entirely excluded. The suggestion of an association between number of long distance flights (possibly related to circadian hormonal disturbances) and prostate cancer needs to be confirmed. What is already known on this topicAirline pilots are occupationally exposed to cosmic radiation and other potentially carcinogenic elementsIn the studies published so far, dose-response patterns have not been characterisedWhat this study addsNo marked risk of cancer attributable to cosmic radiation is observed in airline pilotsA threefold excess of skin cancers is seen among pilots with longer careers, but the influence of recreational exposure to ultraviolet light cannot be quantifiedA slight increase in risk of prostate cancer with increasing number of long haul flights suggests a need for more studies on the effects of circadian hormonal disturbances PMID:12228131

Progressive Staging of Pilot Studies to Improve Phase III Trials for Motor Interventions

PubMed Central

Dobkin, Bruce H.

2014-01-01

Based on the suboptimal research pathways that finally led to multicenter randomized clinical trials (MRCTs) of treadmill training with partial body weight support and of robotic assistive devices, strategically planned successive stages are proposed for pilot studies of novel rehabilitation interventions Stage 1, consideration-of-concept studies, drawn from animal experiments, theories, and observations, delineate the experimental intervention in a small convenience sample of participants, so the results must be interpreted with caution. Stage 2, development-of-concept pilots, should optimize the components of the intervention, settle on most appropriate outcome measures, and examine dose-response effects. A well-designed study that reveals no efficacy should be published to counterweight the confirmation bias of positive trials. Stage 3, demonstration-of-concept pilots, can build out from what has been learned to test at least 15 participants in each arm, using random assignment and blinded outcome measures. A control group should receive an active practice intervention aimed at the same primary outcome. A third arm could receive a substantially larger dose of the experimental therapy or a combinational intervention. If only 1 site performed this trial, a different investigative group should aim to reproduce positive outcomes based on the optimal dose of motor training. Stage 3 studies ought to suggest an effect size of 0.4 or higher, so that approximately 50 participants in each arm will be the number required to test for efficacy in a stage 4, proof-of-concept MRCT. By developing a consensus around acceptable and necessary practices for each stage, similar to CONSORT recommendations for the publication of phase III clinical trials, better quality pilot studies may move quickly into better designed and more successful MRCTs of experimental interventions. PMID:19240197

Untoward effects of a sympathomimetic amine. [decongestant produced arrhythmia in pilot

NASA Technical Reports Server (NTRS)

Billings, C. E.; Ralston, R. H.; Hare, D. E.

1974-01-01

Presentation and discussion of a clinical report describing asymptomatic multifocal ventricular premature contractions in a professional pilot. He had been taking heavy doses of a systemic decongestant agent, pseudoephedrine, prescribed by a physician. He was taken off the medication, and over the next few days the PVCs became less frequent, then disappeared. It is pointed out that physician's instructions to pilots must be given with the realization that some airmen may follow the instructions too zealously in an attempt to remain on flying status.

Safety and metabolic outcomes of resveratrol supplementation in older adults: results of a twelve-week, placebo-controlled pilot study

PubMed Central

Anton, Stephen D.; Embry, Chelsea; Marsiske, Michael; Lud, Xiaomin; Doss, Hani; Leeuwenburgh, Christiaan; Manini, Todd M.

2014-01-01

Resveratrol has been found to have potent antioxidant, anti-inflammatory, and anticarcinogenic effects. The safety and efficacy of resveratrol supplementation in older adults are currently unknown. We conducted a double-blind, randomized, placebo-controlled trial to examine the safety and metabolic outcomes in 32 overweight, older adults (mean age, 73 ± 7 years). Participants were randomized into one of three treatment groups: (1) placebo, (2) moderate dose resveratrol (300 mg/day), and (3) high dose resveratrol (1000 mg/day). Both resveratrol and placebo were orally ingested in capsule form twice daily for 90 days. Blood chemistry values remained within the normal range, and there were no significant differences in the number of participants reporting adverse events across conditions. Compared to placebo, glucose levels were significantly lower at post-treatment among participants randomized to both resveratrol conditions, with and without adjustment for the corresponding baseline values (ps < 0.05). Glucose values of participants in the treatment groups, however, were not significantly different from baseline levels. These findings suggest that short-term resveratrol supplementation at doses of 300 mg/day and 1000 mg/day does not adversely affect blood chemistries and is well tolerated in overweight, older individuals. These findings support the study of resveratrol for improving cardio-metabolic health in older adults in larger clinical trials. PMID:24866496

Pain as an indication for rib fixation: a bi-institutional pilot study.

PubMed

de Moya, Marc; Bramos, Thanos; Agarwal, Suresh; Fikry, Karim; Janjua, Sumbal; King, David R; Alam, Hasan B; Velmahos, George C; Burke, Peter; Tobler, William

2011-12-01

In trauma patients, open reduction and internal fixation of rib fractures remain controversial. We hypothesized that patients who have open reduction and internal fixation of rib fractures would experience less pain compared with controls and thus require fewer opiates. Further, we hypothesized that improved pain control would result in fewer pulmonary complications and decreased length of stay. This is a retrospective bi-institutional matched case-control study. Cases were matched 1:2 by age, injury severity Score, chest abbreviated injury severity score, head abbreviated injury severity score, pulmonary contusion score, and number of fractured ribs. The daily total doses of analgesic drugs were converted to equianalgesic intravenous morphine doses, and the primary outcome was inpatient narcotic administration. Sixteen patients between July 2005 and June 2009 underwent rib fixation in 5 ± 3 days after injury using an average of 3 (1-5) metallic plates. Morphine requirements decreased from 110 mg ± 98 mg preoperatively to 63 ± 57 mg postoperatively (p = 0.01). There were no significant differences between cases and controls in the mean morphine dose (79 ± 63 vs. 76 ± 55 mg, p = 0.65), hospital stay (18 ± 12 vs. 16 ± 11 days, p = 0.67), intensive care unit stay (9 ± 8 vs. 7 ± 10 days, p = 0.75), ventilation days (7 ± 8 vs. 6 ± 10, p = 0.44), and pneumonia rates (31% vs. 38%, p = 0.76). The need for analgesia was significantly reduced after rib fixation in patients with multiple rib fractures. However, no difference in outcomes was observed when these patients were compared with matched controls in this pilot study. Further study is required to investigate these preliminary findings.

A pilot study: dose adaptation of capecitabine using mobile phone toxicity monitoring - supporting patients in their homes.

PubMed

Weaver, Andrew; Love, Sharon B; Larsen, Mark; Shanyinde, Milensu; Waters, Rachel; Grainger, Lisa; Shearwood, Vanessa; Brooks, Claire; Gibson, Oliver; Young, Annie M; Tarassenko, Lionel

2014-10-01

Real-time symptom monitoring using a mobile phone is potentially advantageous for patients receiving oral chemotherapy. We therefore conducted a pilot study of patient dose adaptation using mobile phone monitoring of specific symptoms to investigate relative dose intensity of capecitabine, level of toxicity and perceived supportive care. Patients with breast or colorectal cancer receiving capecitabine completed a symptom, temperature and dose diary twice a day using a mobile phone application. This information was encrypted and automatically transmitted in real time to a secure server, with moderate levels of toxicity automatically prompting self-care symptom management messages on the screen of the patient's mobile phone or in severe cases, a call from a specialist nurse to advise on care according to an agreed protocol. Patients (n = 26) completed the mobile phone diary on 92.6 % of occasions. Twelve patients had a maximum toxicity grade of 3 (46.2 %). The average dose intensity for all patients as a percentage of standard dose was 90 %. In eight patients, the dose of capecitabine was reduced, and in eight patients, the dose of capecitabine was increased. Patients and healthcare professionals involved felt reassured by the novel monitoring system, in particular, during out of hours. It is possible to optimise the individual dose of oral chemotherapy safely including dose increase and to manage chemotherapy side effects effectively using real-time mobile phone monitoring of toxicity parameters entered by the patient.

TU-FG-201-06: Remote Dosimetric Auditing for Clinical Trials Using EPID Dosimetry: A Pilot Study

DOE Office of Scientific and Technical Information (OSTI.GOV)

Miri, N; Legge, K; Greer, P

2016-06-15

Purpose: To perform a pilot study for remote dosimetric credentialing of intensity modulated radiation therapy (IMRT) based clinical trials. The study introduces a novel, time efficient and inexpensive dosimetry audit method for multi-center credentialing. The method employs electronic portal imaging device (EPID) to reconstruct delivered dose inside a virtual flat/cylindrical water phantom. Methods: Five centers, including different accelerator types and treatment planning systems (TPS), were asked to download two CT data sets of a Head and Neck (H&N) and Postprostatectomy (P-P) patients to produce benchmark plans. These were then transferred to virtual flat and cylindrical phantom data sets that weremore » also provided. In-air EPID images of the plans were then acquired, and the data sent to the central site for analysis. At the central site, these were converted to DICOM format, all images were used to reconstruct 2D and 3D dose distributions inside respectively the flat and cylindrical phantoms using inhouse EPID to dose conversion software. 2D dose was calculated for individual fields and 3D dose for the combined fields. The results were compared to corresponding TPS doses. Three gamma criteria were used, 3%3mm-3%/2mm–2%/2mm with a 10% dose threshold, to compare the calculated and prescribed dose. Results: All centers had a high pass rate for the criteria of 3%/3 mm. For 2D dose, the average of centers mean pass rate was 99.6% (SD: 0.3%) and 99.8% (SD: 0.3%) for respectively H&N and PP patients. For 3D dose, 3D gamma was used to compare the model dose with TPS combined dose. The mean pass rate was 97.7% (SD: 2.8%) and 98.3% (SD: 1.6%). Conclusion: Successful performance of the method for the pilot centers establishes the method for dosimetric multi-center credentialing. The results are promising and show a high level of gamma agreement and, the procedure is efficient, consistent and inexpensive. Funding has been provided from Department of Radiation Oncology, TROG Cancer Research and the University of Newcastle. Narges Miri is a recipient of a University of Newcastle postgraduate scholarship.« less

A mixed methods pilot study to investigate the impact of a hospital-specific iPhone application (iTreat) within a British junior doctor cohort.

PubMed

Payne, Karl Fb; Weeks, Lucy; Dunning, Paul

2014-03-01

We present a pilot study to investigate the impact of introducing a hospital-specific smartphone application into a cohort of British junior doctors. We created the iPhone application 'iTreat' that contained disease management and antibiotic dosing guidelines specific to our hospital, together with a postgraduate education department really simple syndication feed, a contact number phonebook and a favourites section. This intervention was trialled in a group of 39 foundation grade junior doctors, in a UK hospital, for a time period of 4 months. Mixed methods data capture, utilising survey and semi-structured interviews, was used to evaluate application usage patterns and potential barriers to endorsement of smartphone technology in the hospital setting. Sixty eight per cent of participants felt the application saved them time during clinical activities, with a decrease in the frequency of participants not referring to hospital clinical guidelines. The findings from this pilot study point towards the internal hospital environment as having a major impact upon smartphone usage. Participants viewed smartphone use as unprofessional in the ward-based setting, with a perceived negative attitude from other healthcare staff. An understanding of how healthcare staff choose to utilise smartphones in the clinical environment is crucial to enable the successful assimilation of smartphone technology into the hospital setting. This pilot study provides experience and parameters for future substantive studies being carried out by this group.

A PILOT STUDY USING AN ACCELEROMETER TO EVALUATE A CAREGIVER'S INTERPRETATION OF AN INFANT OR TODDLER'S ACTIVITY LEVEL AS RECORDED IN A TIME ACTIVITY DIARY

EPA Science Inventory

Linking a young child's activity pattern data with samples that are collected during an exposure assessment is important in evaluating uptake dose rates associated with environmental contaminant exposures. A pilot study (N=9) was performed to test how well categorical activity-le...

Pilot Study of the 5-HT2AR Agonist Psilocybin in the Treatment of Tobacco Addiction

PubMed Central

Johnson, Matthew W.; Garcia-Romeu, Albert; Cosimano, Mary P.; Griffiths, Roland R.

2014-01-01

Despite suggestive early findings on the therapeutic use of hallucinogens in the treatment of substance use disorders, rigorous follow up has not been conducted. To determine the safety and feasibility of psilocybin as an adjunct to tobacco smoking cessation treatment we conducted an open-label pilot study administering moderate (20mg/70kg) and high (30mg/70kg) doses of psilocybin within a structured 15-week smoking cessation treatment protocol. Participants were 15 psychiatrically healthy nicotine-dependent smokers (10 males; mean age of 51 years), with a mean of 6 previous lifetime quit attempts, and smoking a mean of 19 cigarettes per day for a mean of 31 years at intake. Biomarkers assessing smoking status, and self-report measures of smoking behavior demonstrated that 12 of 15 participants (80%) showed seven-day point prevalence abstinence at 6-month follow-up. The observed smoking cessation rate substantially exceeds rates commonly reported for other behavioral and/or pharmacological therapies (typically <35%). Although the open-label design does not allow for definitive conclusions regarding the efficacy of psilocybin, these findings suggest psilocybin may be a potentially efficacious adjunct to current smoking cessation treatment models. The present study illustrates a framework for future research on the efficacy and mechanisms of hallucinogen-facilitated treatment of addiction. PMID:25213996

Effects of Combining a Brief Cognitive Intervention with Transcranial Direct Current Stimulation on Pain Tolerance: A Randomized Controlled Pilot Study.

PubMed

Powers, Abigail; Madan, Alok; Hilbert, Megan; Reeves, Scott T; George, Mark; Nash, Michael R; Borckardt, Jeffrey J

2018-04-01

Cognitive behavioral therapy has been shown to be effective for treating chronic pain, and a growing literature shows the potential analgesic effects of minimally invasive brain stimulation. However, few studies have systematically investigated the potential benefits associated with combining approaches. The goal of this pilot laboratory study was to investigate the combination of a brief cognitive restructuring intervention and transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex in affecting pain tolerance. Randomized, double-blind, placebo-controlled laboratory pilot. Medical University of South Carolina. A total of 79 healthy adult volunteers. Subjects were randomized into one of six groups: 1) anodal tDCS plus a brief cognitive intervention (BCI); 2) anodal tDCS plus pain education; 3) cathodal tDCS plus BCI; 4) cathodal tDCS plus pain education; 5) sham tDCS plus BCI; and 6) sham tDCS plus pain education. Participants underwent thermal pain tolerance testing pre- and postintervention using the Method of Limits. A significant main effect for time (pre-post intervention) was found, as well as for baseline thermal pain tolerance (covariate) in the model. A significant time × group interaction effect was found on thermal pain tolerance. Each of the five groups that received at least one active intervention outperformed the group receiving sham tDCS and pain education only (i.e., control group), with the exception of the anodal tDCS + education-only group. Cathodal tDCS combined with the BCI produced the largest analgesic effect. Combining cathodal tDCS with BCI yielded the largest analgesic effect of all the conditions tested. Future research might find stronger interactive effects of combined tDCS and a cognitive intervention with larger doses of each intervention. Because this controlled laboratory pilot employed an acute pain analogue and the cognitive intervention did not authentically represent cognitive behavioral therapy per se, the implications of the findings on chronic pain management remain unclear.

ULTRAVIOLET DISINFECTION OF A SECONDARY EFFLUENT: MEASUREMENT OF DOSE AND EFFECTS OF FILTRATION

EPA Science Inventory

Ultraviolet (UV) disinfection of wastewater secondary effluent was investigated in a two-phase study to develop methods for measuring UV dose and to determine the effects of filtration on UV disinfection. The first phase of this study involved a pilot plant study comparing filtra...

Intraoperative Methadone in Same-Day Ambulatory Surgery: A Randomized, Double-Blinded, Dose-Finding Pilot Study.

PubMed

Komen, Helga; Brunt, L Michael; Deych, Elena; Blood, Jane; Kharasch, Evan D

2018-05-25

Approximately 50 million US patients undergo ambulatory surgery annually. Postoperative opioid overprescribing is problematic, yet many patients report inadequate pain relief. In major inpatient surgery, intraoperative single-dose methadone produces better analgesia and reduces opioid use compared with conventional repeated dosing of short-duration opioids. This investigation tested the hypothesis that in same-day ambulatory surgery, intraoperative methadone, compared with short-duration opioids, reduces opioid consumption and pain, and determined an effective intraoperative induction dose of methadone for same-day ambulatory surgery. A double-blind, dose-escalation protocol randomized 60 patients (2:1) to intraoperative single-dose intravenous methadone (initially 0.1 then 0.15 mg/kg ideal body weight) or conventional as-needed dosing of short-duration opioids (eg, fentanyl, hydromorphone; controls). Intraoperative and postoperative opioid consumption, pain, and opioid side effects were assessed before discharge. Patient home diaries recorded pain, opioid use, and opioid side effects daily for 30 days postoperatively. Primary outcome was in-hospital (intraoperative and postoperative) opioid use. Secondary outcomes were 30 days opioid consumption, pain intensity, and opioid side effects. Median (interquartile range) methadone doses were 6 (5-6) and 9 (8-9) mg in the 0.1 and 0.15 mg/kg methadone groups, respectively. Total opioid consumption (morphine equivalents) in the postanesthesia care unit was significantly less compared with controls (9.3 mg, 1.3-11.0) in subjects receiving 0.15 mg/kg methadone (0.1 mg, 0.1-3.3; P < .001) but not 0.1 mg/kg methadone (5.0 mg, 3.3-8.1; P = .60). Dose-escalation ended at 0.15 mg/kg methadone. Total in-hospital nonmethadone opioid use after short-duration opioid, 0.1 mg/kg methadone, and 0.15 mg/kg methadone was 35.3 (25.0-44.0), 7.1 (3.7-10.0), and 3.3 (0.1-5.8) mg morphine equivalents, respectively (P < .001 for both versus control). In-hospital pain scores and side effects were not different between groups. In the 30 days after discharge, patients who received methadone 0.15 mg/kg had less pain at rest (P = .02) and used fewer opioid pills than controls (P < .0001), whereas patients who received 0.1 mg/kg had no difference in pain at rest (P = .69) and opioid use compared to controls (P = .08). In same-day discharge surgery, this pilot study identified a single intraoperative dose of methadone (0.15 mg/kg ideal body weight), which decreased intraoperative and postoperative opioid requirements and postoperative pain, compared with conventional intermittent short-duration opioids, with similar side effects.

A pilot stability study on four-drug fixed-dose combination anti-tuberculosis products.

PubMed

Singh, S; Mohan, B

2003-03-01

A pilot stability study was carried out on four fixed-dose combination anti-tuberculosis products at 40 degrees C and 75% RH. The strip-packed products were stable, while the blister-packed products showed both physical and chemical changes. The products in unpacked conditions showed severe (approximately 60%) decomposition of rifampicin and extensive physical changes. The main decomposition product in the solid state was isonicotinyl hydrazone of 3-formylrifamycin and isoniazid. It is suggested that attention should be paid to the detection and quantitation of this product in the marketed formulations. The packing material used in the manufacture of FDC products should also be of the highest quality.

A Pilot Study of Cerebral and Hemodynamic Changes During Sedation with Low Dose of Thiopental Sodium or Propofol in Patients with Acute Brain Injury.

PubMed

Yaghoobi, Siamak; Khezri, Marzieh Beigom; Alamouti, Azam Mohammadi

2015-08-01

One of the most important therapeutic maneuvers in head injury patients is to maintain Intracranial Pressure (ICP) and Cerebral Perfusion Pressure (CPP) within normal levels. To compare the effects of low dose of thiopental sodium and propofol on reducing ICP and CPP in patients with head injury that scheduled for neurosurgical interventions. Using a randomized, crossover pilot study, we enrolled patients with head injury that scheduled for neurosurgical interventions admitted to ICU unit of a teaching hospital during 2010 to 2011. In this pilot study, patients randomized into two equal groups. The first group received bolus injection of thiopental sodium 2 mg/kg and a maintenance dose of 2 mg/kg/h and the second group was given a bolus dose of propofol 0.5 mg/kg followed by propofol infusion 20 μg/kg/min. All of patients were given dexamethasone 8 mg at time of catheter insertion. ICP measurement catheter was inserted for each patient and ICP, CPP, SPO2 and MAP were recorded hourly for a period of 6 hours. There was no significant difference in sex and age between the two study groups (p>0.05). The mean ICP, CPP, SPO2 and arterial blood pressure were found to be similar with no significant difference between both groups (p>0.05). Both propofol and thiopental sodium were equally effective in monitoring and maintaining CPP and MAP and eventually an ideal SPO2.

Methadone Dose at the Time of Release from Prison Significantly Influences Retention in Treatment: Implications From a Pilot Study of HIV-Infected Prisoners Transitioning to the Community in Malaysia

PubMed Central

Wickersham, Jeffrey A.; Muhsin Zahari, Muhammad; Azar, Marwan M.; Kamarulzaman, Adeeba; Altice, Frederick L.

2013-01-01

Objective To evaluate the impact of methadone dose on post-release retention in treatment among HIV-infected prisoners initiating methadone maintenance treatment (MMT) within prison. Methods Thirty HIV-infected prisoners meeting DSM-IV pre-incarceration criteria for opioid dependence were enrolled in a prison-based, pre-release MMT program in Klang Valley, Malaysia; 3 died before release from prison leaving 27 evaluable participants. Beginning 4 months before release, standardized methadone initiation and dose escalation procedures began with 5mg daily for the first week and 5mg/daily increases weekly until 80 mg/day or craving was satisfied. Participants were followed for 12 months post-release at a MMT clinic within 25 kilometers of the prison. Kaplan-Meier survival analysis was used to evaluate the impact of methadone dose on post-release retention in treatment. Findings Methadone dose ≥80 mg/day at the time of release was significantly associated with retention in treatment. After 12 months of release, only 21.4% of participants on <80mg were retained at 12 months compared to 61.5% of those on ≥80mg (Log Rank χ2=(1,26) 7.6, p <0.01). Conclusions Higher doses of MMT at time of release are associated with greater retention on MMT after release to the community. Important attention should be given to monitoring and optimizing MMT doses to address cravings and side effects prior to community re-entry from prisons. PMID:23414931

[Diabetes and fasting during Ramadan. A observational study among Turkish immigrants in Belgium].

PubMed

Peeters, B; Mehuys, E; Van Tongelen, I; Van Bever, E; Bultereys, L; Avonts, D; Yildiz, G; Remon, J P; Boussery, K

2013-03-01

To investigate (i) Ramadan participation, (ii) provision of Ramadan related advice by healthcare providers (iii) medication use during Ramadan fasting among Turkish migrants with diabetes in Belgium. This pilot observational study was conducted among a convenience sample of 52 Turkish migrants with diabetes in Belgium. Two questionnaires collected information on socio-demographic characteristics, diabetes related characteristics, current hypoglycaemic medication with dosing regimen, participation in the past Ramadan, reasons for (non)participation, use of hypoglycaemic medication during the past Ramadan, advice from their healthcare providers about fasting during Ramadan and follow up of this advice. Sixteen patients (31%) had fasted during the past Ramadan. Main reason for Ramadan participation was reinforcement of faith (12/15), while the main reason for non participation was having diabetes (34/36). About 56% of the study population had received recommendations from their healthcare provider(s) about fasting and diabetes during Ramadan. The most commonly provided advice was not to participate in Ramadan, followed by modification of drug therapy. Only 3 patients ignored the advice of their healthcare professionals. In addition, only 60% of those who actually fasted received recommendations about intake of diabetes medication during the ramadan. Most fasters continued their medication dose unchanged (87% of OHA users and 80% of the insulin users). This pilot study found a low prevalence of Ramadan fasting among Turkish migrants with diabetes in Belgium. We also found that provision of advice by healthcare providers could be improved. Larger scale studies are warranted to confirm these findings.

ASSESSING ASTHMATIC CHILDREN'S EXPOSURES TO TOXIC AIR POLLUTANTS AND THE POTENTIAL INHALED DOSES USING TIME ACTIVITY INFORMATION AND ENERGY EXPENDITURE DATA

EPA Science Inventory

Accurately quantifying human exposures and the potential doses of various populations to environmental pollutants is critical for the U.S. Environmental Protection Agency to assess and manage human health risks. The Tampa Asthmatic Children's Study (TACS) was a pilot research stu...

Principles of Technology. Units 1-10 Pilot Test Findings.

ERIC Educational Resources Information Center

Center for Occupational Research and Development, Inc., Waco, TX.

This document provides the findings of pilot tests of 10 units for an applied science course for high school vocational students. Each of the reports on the pilot tests of the Principles of Technology units contains information on procedures, methodology limitations, sample, the pretest/posttest instrument and results, student attitude results,…

The current status of eye lens dose measurement in interventional cardiology personnel in Thailand.

PubMed

Krisanachinda, Anchali; Srimahachota, Suphot; Matsubara, Kosuke

2017-06-01

Workers involved in interventional cardiology procedures receive high eye lens doses if radiation protection tools are not properly utilized. Currently, there is no suitable method for routine measurement of eye dose. In Thailand, the eye lens equivalent doses in terms of Hp(3) of the interventional cardiologists, nurses, and radiographers participating in interventional cardiology procedures have been measured at 12 centers since 2015 in the pilot study. The optically stimulated luminescence (OSL) dosimeter was used for measurement of the occupational exposure and the eye lens dose of 42 interventional cardiology personnel at King Chulalongkorn Memorial Hospital as one of the pilot centers. For all personnel, it is recommended that a first In Light OSL badge is placed at waist level and under the lead apron for determination of Hp(10); a second badge is placed at the collar for determination of Hp(0.07) and estimation of Hp(3). Nano Dots OSL dosimeter has been used as an eye lens dosimeter for 16 interventional cardiology personnel, both with and without lead-glass eyewear. The mean effective dose at the body, equivalent dose at the collar, and estimated eye lens dose were 0.801, 5.88, and 5.70 mSv per year, respectively. The mean eye lens dose measured by the Nano Dots dosimeter was 8.059 mSv per year on the left eye and 3.552 mSv per year on the right eye. Two of 16 interventional cardiologists received annual eye lens doses on the left side without lead glass that were higher than 20 mSv per year, the new eye lens dose limit as recommended by ICRP with the risk of eye lens opacity and cataract.

Total and free cortisol levels during 1 μg, 25 μg, and 250 μg cosyntropin stimulation tests compared to insulin tolerance test: results of a randomized, prospective, pilot study.

PubMed

Peechakara, Seenia; Bena, James; Clarke, Nigel J; McPhaul, Michael J; Reitz, Richard E; Weil, Robert J; Recinos, Pablo; Kennedy, Laurence; Hamrahian, Amir H

2017-09-01

The appropriate cosyntropin dose during cosyntropin stimulation tests remains uncertain. We conducted a prospective, randomized pilot study to compare 1 μg IV low dose cosyntropin test, 25 μg IM medium dose cosyntropin test, and 250 μg IM standard dose cosyntropin test to evaluate secondary adrenal insufficiency. Insulin tolerance test was used as the gold standard. The study included patients with hypothalamic/pituitary disease (n  = 10) with at least one pituitary axis deficiency other than ACTH deficiency and controls (n  = 12). All tests were done in random order. Sensitivity and specificity were calculated for total cortisol and serum free cortisol cut-off levels during cosyntropin stimulation tests. The median (range) age and F/M sex ratios for patients and controls were 54 years (23-62), 2/8, and 33 years (21-51), 6/6, respectively. The best total cortisol cut-off during low dose cosyntropin test, medium dose cosyntropin test, 30 min and 60 min standard dose cosyntropin test were 14.6 μg/dL (100% sensitivity & specificity), 18.7 μg/dL (100% sensitivity, 88% specificity), 16.1 (100% sensitivity & specificity), and 19.5 μg/dL (100% sensitivity & specificity), respectively. There was no difference in the ROC curve for cortisol values between the cosyntropin stimulation tests (p  > 0.41). Using a cortisol cut-off of 18 μg/dL during cosyntropin stimulation tests, only cortisol level at 30 min during standard dose cosyntropin test provided discrimination similar to insulin tolerance test. The best peak free cortisol cut-off levels were 1 μg/dL for insulin tolerance test, 0.9 μg/dL for low dose cosyntropin test, 0.9 μg/dL for medium dose cosyntropin test, and 0.9 μg/dL and 1.3 μg/dL for 30 min and 60 min standard dose cosyntropin test, respectively. All cosyntropin stimulation tests had excellent correlations with insulin tolerance test, when appropriate cut-offs were used. This pilot study does not suggest an advantage in using 25 μg cosyntropin dose during the cosyntropin stimulation test. A serum free cortisol cut-off of 0.9 μg/dL may be used as pass criterion during low dose cosyntropin test, standard dose cosyntropin test cosyntropin test, and 30 min standard dose cosyntropin test.

Impact of Cannabis Use During Stabilization on Methadone Maintenance Treatment

PubMed Central

Scavone, Jillian L.; Sterling, Robert C.; Weinstein, Stephen P.; Van Bockstaele, Elisabeth J.

2016-01-01

Background and Objectives Illicit drug use, particularly of cannabis, is common among opiate-dependent individuals, and has the potential to impact treatment in a negative manner. Methods To examine this, patterns of cannabis use prior to and during methadone maintenance treatment (MMT) were examined to assess possible cannabis-related effects on MMT, particularly during methadone stabilization. Retrospective chart analysis was used to examine outpatient records of patients undergoing MMT (n=91), focusing specifically on past and present cannabis use and its association with opiate abstinence, methadone dose stabilization, and treatment compliance. Results Objective rates of cannabis use were high during methadone induction, dropping significantly following dose stabilization. History of cannabis use correlated with cannabis use during MMT, but did not negatively impact the methadone induction process. Pilot data also suggested that objective ratings of opiate withdrawal decrease in MMT patients using cannabis during stabilization. Conclusions and Scientific Significance The present findings may point to novel interventions to be employed during treatment for opiate dependence that specifically target cannabinoid-opioid system interactions. PMID:23795873

A clinical trial of injectable testosterone undecanoate as a potential male contraceptive in normal Chinese men.

PubMed

Zhang, G Y; Gu, Y Q; Wang, X H; Cui, Y G; Bremner, W J

1999-10-01

This is a pilot dose-finding study of spermatogenic suppression using testosterone undecanoate (TU) injections alone in normal Chinese men. Thirty-two healthy men were recruited. Volunteers underwent pretreatment evaluation, then a treatment period in which group I (n = 13) received 500 mg TU, group II (n = 12) received 1000 mg TU, and group III (n = 7) received placebo, respectively, at monthly intervals during the treatment period (or until azoospermia was achieved). Thereafter, they underwent a recovery period until all parameters returned to pretreatment levels. Eleven of 12 volunteers in the 500-mg TU group, and all volunteers in the 1000-mg TU group became azoospermic. Faster suppression of spermatogenesis was achieved in the 1000-mg TU group. Serum testosterone increased significantly in the higher dose group at weeks 8 and 12, but remained within the normal range. Mean serum LH and FSH were profoundly suppressed by both doses to undetectable levels at week 16. TU injections did not cause a significant change in high density lipoprotein cholesterol levels. No serious side-effects were found. We conclude that both dosages of TU can effectively, safely, and reversibly suppress spermatogenesis in normal Chinese men.

TLD extrapolation for skin dose determination in vivo.

PubMed

Kron, T; Butson, M; Hunt, F; Denham, J

1996-11-01

Prediction of skin reactions requires knowledge of the dose at various depths in the human skin. Using thermoluminescence dosimeters of three different thicknesses, the dose can be extrapolated to the surface and interpolated between the different depths. A TLD holder was designed for these TLD extrapolation measurements on patients during treatment which allowed measurements of entrance and exit skin dose with a day to day variability of +/-7% (S.D. of mean reading). In a pilot study on 18 patients undergoing breast irradiation, it was found that the angle of incidence of the radiation beam is the most significant factor influencing skin entrance dose. In most of these measurements the beam exit dose contributed 50% more to the surface dose than the entrance dose.

Pilot study investigating the effects of Ayurvedic Abhyanga massage on subjective stress experience.

PubMed

Basler, Annetrin Jytte

2011-05-01

Many providers of Ayurvedic massage treatments make unsubstantiated claims regarding their potential psychologic and physiologic benefits. While these claims are based on ancient traditions of the Indian medical system as well as personal experience, no attempt had yet been made to verify the effect of Ayurvedic oil massage within the Western-scientific context. This pilot study assessed the single-dose effect of Abhyanga, the classic Ayurvedic oil massage, in terms of its impact on subjective stress experience. Ten (10) healthy women (mean [M] 36.4 years, standard deviation [SD] 4.62) and 10 healthy men (M 37.0 years, SD 3.23) underwent a 1-hour Abhyanga massage treatment. The study employed a repeated-measures design for the collection of stress data using a validated and published questionnaire, as well as for the collection of heart rate (HR) and blood pressure (BP) values, immediately pre- and postintervention. Subjects showed high statistically and clinically significant reductions in subjective stress experience. A consequent analysis of physiologic data indicated likewise reductions in HR, while a BP reduction was not recorded for the total sample, but was only found in the prehypertensive subgroup. Findings indicate that Abhyanga massage is promising in reducing subjective stress experience. It may be beneficial in lowering HR in all, and BP in prehypertensive subjects. The results of this pilot study encourage further research with more stringent methodology.

Impact of Methylphenidate Delivery Profiles on Driving Performance of Adolescents with Attention-Deficit/hyperactivity Disorder: A Pilot Study

ERIC Educational Resources Information Center

Cox, Daniel J.; Merkel, R. Lawrence; Penberthy, Jennifer Kim; Kovatchev, Boris; Hankin, Cheryl S.

2004-01-01

Objective: Adolescents with attention-deficit/hyperactivity disorder (ADHD) are at high risk for driving accidents. One dose of methylphenidate (MPH) improves simulator driving performances of ADHD-diagnosed adolescents at 1.5 hours post-dose. However, little is known about the effects of different MPH delivery profiles on driving performance…

Pilot study of the 5-HT2AR agonist psilocybin in the treatment of tobacco addiction.

PubMed

Johnson, Matthew W; Garcia-Romeu, Albert; Cosimano, Mary P; Griffiths, Roland R

2014-11-01

Despite suggestive early findings on the therapeutic use of hallucinogens in the treatment of substance use disorders, rigorous follow-up has not been conducted. To determine the safety and feasibility of psilocybin as an adjunct to tobacco smoking cessation treatment we conducted an open-label pilot study administering moderate (20 mg/70 kg) and high (30 mg/70 kg) doses of psilocybin within a structured 15-week smoking cessation treatment protocol. Participants were 15 psychiatrically healthy nicotine-dependent smokers (10 males; mean age of 51 years), with a mean of six previous lifetime quit attempts, and smoking a mean of 19 cigarettes per day for a mean of 31 years at intake. Biomarkers assessing smoking status, and self-report measures of smoking behavior demonstrated that 12 of 15 participants (80%) showed seven-day point prevalence abstinence at 6-month follow-up. The observed smoking cessation rate substantially exceeds rates commonly reported for other behavioral and/or pharmacological therapies (typically <35%). Although the open-label design does not allow for definitive conclusions regarding the efficacy of psilocybin, these findings suggest psilocybin may be a potentially efficacious adjunct to current smoking cessation treatment models. The present study illustrates a framework for future research on the efficacy and mechanisms of hallucinogen-facilitated treatment of addiction. © The Author(s) 2014.

Findings from the Pilot Teacher Compensation Survey: School Year 2005-06. First Look. NCES 2008-440

ERIC Educational Resources Information Center

Johnson, Frank; Cornman, Stephen

2008-01-01

This report presents findings from the Pilot Teacher Compensation Survey (TCS), which collected data for school year 2005-2006. This pilot collection is a research and development effort to see if it is possible to collect and publish teacher-level data from the administrative records residing in state departments of education. Seven states…

High Dose and Delayed Treatment with Bile Acids Ineffective in RML Prion-Infected Mice.

PubMed

Norman, Grant; Campeau, Jody; Sim, Valerie L

2018-05-21

Prion diseases are a group of neurodegenerative diseases associated with the misfolding of the cellular prion protein (PrP C ) into the infectious form (PrP Sc ). There are currently no treatments for prion disease. Bile acids have the ability to protect hepatocytes from apoptosis and are neuroprotective in animal models of other protein folding neurodegenerative diseases including Huntington's, Parkinson's, and Alzheimer's disease. Importantly, bile acids are approved for clinical use in patients with cirrhosis, and have recently been shown to be safe and possibly effective in pilot trials of patients with amyotrophic lateral sclerosis (ALS). We previously reported that the bile acid, ursodeoxycholic acid (UDCA), given early in disease, prolonged incubation periods in male RML-infected mice. Here we expand on this result to include tauro-ursodeoxycholic acid (TUDCA) treatment trials and delayed UDCA treatment. We demonstrate that, despite a high dose of TUDCA given early in disease, there was no significant difference in incubation periods between treated and untreated cohorts, regardless of sex. In addition, delayed treatment with a high dose of UDCA resulted in a significant shortening of the average survival time for both male and female mice when compared to their sex-matched controls, with evidence of increased BiP, a marker of apoptosis, in treated female mice. Our findings suggest that treatment with high dose TUDCA provides no therapeutic benefit and that delayed treatment with high dose UDCA is ineffective and could potentially worsen outcomes. Copyright © 2018 American Society for Microbiology.

Tertiary treatment using microfiltration and UV disinfection for water reclamation

DOE Office of Scientific and Technical Information (OSTI.GOV)

Jolis, D.; Hirano, R.; Pitt, P.

Microfiltration and UV disinfection are two alternative technologies for water reclamation. The results of a pilot study combining these two processes are presented. In addition to producing filtrate turbidites averaging 0.06 nephelometric turbidity units, microfiltration was an effective barrier to pathogens, demonstrating average log reductions of 4.5 for total coliforms and 2.9 for MS2 bacteriophage. Ultraviolet disinfection following microfiltration reliably met the California Wastewater Reclamation Criteria (Title 22) total coliform standard of 2.2 colony-forming units/100 mL at a UV dose of 450 J/m{sup 2}. The MS2 bacteriophage standard, which requires a 5-log reduction, was achieved by microfiltration and a UVmore » dose of 880 J/m{sup 2}. A model of the kinetics of inactivation of MS2 bacteriophage was used in further analysis of disinfection data. The model indicated that considerable backmixing occurred in the pilot UV disinfection unit, and observed UV doses could be reduced with improved hydraulics.« less

Cosmic radiation increases the risk of nuclear cataract in airline pilots: a population-based case-control study.

PubMed

Rafnsson, Vilhjalmur; Olafsdottir, Eydis; Hrafnkelsson, Jon; Sasaki, Hiroshi; Arnarsson, Arsaell; Jonasson, Fridbert

2005-08-01

Aviation involves exposure to ionizing radiation of cosmic origin. The association between lesions of the ocular lens and ionizing radiation is well-known. To investigate whether employment as a commercial airline pilot and the resulting exposure to cosmic radiation is associated with lens opacification. This is a population-based case-control study of 445 men. Lens opacification was classified into 4 types using the World Health Organization simplified grading system. These 4 types, serving as cases, included 71 persons with nuclear cataracts, 102 with cortical lens opacification, 69 with central optical zone involvement, and 32 with posterior subcapsular lens opacification. Control subjects are those with a different type of lens opacification or without lens opacification. Exposure was assessed based on employment time as pilots, annual number of hours flown on each aircraft type, time tables, flight profiles, and individual cumulative radiation doses (in millisieverts) calculated by a software program. Odds ratios were calculated using logistic regression. The odds ratio for nuclear cataract risk among cases and controls was 3.02 (95% confidence interval, 1.44-6.35) for pilots compared with nonpilots, adjusted for age, smoking status, and sunbathing habits. The odds ratio for nuclear cataract associated with estimation of cumulative radiation dose (in millisieverts) to the age of 40 years was 1.06 (95% confidence interval, 1.02-1.10), adjusted for age, smoking status, and sunbathing habits. The association between the cosmic radiation exposure of pilots and the risk of nuclear cataracts, adjusted for age, smoking status, and sunbathing habits, indicates that cosmic radiation may be a causative factor in nuclear cataracts among commercial airline pilots.

Open-label pilot study of memantine in the treatment of compulsive buying.

PubMed

Grant, Jon E; Odlaug, Brian L; Mooney, Marc; O'Brien, Robert; Kim, Suck Won

2012-05-01

Although compulsive buying (CB) is relatively common, pharmacotherapy research for CB is limited. Memantine, an N-methyl-D-aspartate receptor antagonist, appears to reduce glutamate excitability and improve impulsive behaviors, suggesting it may help individuals with CB. Nine patients (8 females) with CB were enrolled in a 10-week open-label treatment study of memantine (dose ranging from 10 to 30 mg/d). Participants were enrolled from December 2008 until May 2010. The primary outcome measure was change from baseline to study endpoint on the Yale-Brown Obsessive Compulsive Scale-Shopping Version (Y-BOCS-SV). Of the 9 participants, 8 (88.9%) completed the 10-week study. Y-BOCS-SV scores decreased from a mean of 22.0 ± 1.3 at baseline to 11.0 ± 5.3 at endpoint (P < .001). Hours spent shopping per week and money spent shopping both decreased significantly (P < .001). The mean effective dose of memantine was 23.4 ± 8.1 mg/d. Memantine treatment was associated with diminished impulsive buying and improvements on cognitive tasks of impulsivity. In addition, the medication was well-tolerated. These findings suggest that pharmacologic manipulation of the glutamate system may target the impulsive behavior underlying CB. Placebo-controlled, double-blind studies are warranted in order to confirm these preliminary findings in a controlled design.

Tactile massage reduces rescue doses for pain and anxiety: an observational study.

PubMed

Pedersen, Karina; Björkhem-Bergman, Linda

2018-03-01

The aim of this study was to evaluate the effect of tactile massage (TM) on palliative care patients. An observational study at a hospice ward in Sweden was carried out. Forty-one palliative patients were offered TM, at an average of three treatments per patient. Before and after every treatment, self-assessed pain, well-being and anxiety according to the Edmonton Symptom Assessment Scale (0-10) were recorded. In addition, the number of rescue doses for pain and anxiety was monitored 24 hours before and after the treatment and in two consecutive days before the patients were offered TM (control data). TM resulted in improvement of self-assessed pain by 1.7 points (SD 1.6), anxiety by 2.3 points (SD 2.0) and well-being by 2.6 points (SD 1.4). The number of rescue doses for pain was reduced from 1.6 to 0.84 doses/patient (P<0.001) and for anxiety from 0.52 to 0.24 doses/patient (P<0.01). The number of rescue doses was not changed in the same patients in two consecutive days before the patients were offered TM. The effect was evident already after the first treatment and did not increase further with repeated treatments. No patients reported any harmful effects of the treatment. TM reduced the need for administration of rescue doses for pain and anxiety and improved well-being in palliative care patients. Larger randomised studies with parallel control groups are needed to confirm the findings from this observational pilot study. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Effects of the Chemical Defense Antidote Atropine Sulfate on Helicopter Pilot Performance: An In-Flight Study

DTIC Science & Technology

1991-06-01

reported minor hallucinations . Digging ;,rt -,-,7in -e wis degraded overall and number facility was impaired en the aiernoon of the atropine day...at higher doses; 4) loss of coordination with doses higher than 10 mg; and 5) hallucinations with very large doses of atropine. Longo’s (1966) review...diopter of refractive error, possessed normal hearing , and was between the ages of 24 and 32 (mean=29.1). Each one received a complete physical

Evaluation of the School Breakfast Program Pilot Project: Findings from the First Year of Implementation. Nutrition Assistance Program Report Series.

ERIC Educational Resources Information Center

McLaughlin, Joan E.; Bernstein, Lawrence S.; Crepinsek, May Kay; Daft, Lynn M.; Murphy, J. Michael

In 1998, Congress authorized implementation of a 3-year pilot breakfast program involving 4,300 students in elementary schools in 6 school districts representing a range of economic and demographic characteristics. The program began in the 2000-01 school year. This lengthy report presents the findings from the pilot's first year. The study had two…

Anti-Emetic Drug Effects on Pilot Performance, Phase 2: Simulation Test.

DTIC Science & Technology

1996-04-01

The objectives of this study were to evaluate the effects of two anti-emetic drugs, granisetron (2 mg oral dose) and ondansetron (8 mg oral dose), on...and preduce no cognitive, psychomotor or subjective state changes. In this study, there was no evidence of performance degradation caused by either granisetron or ondansetron when tested in a complex military task environment.

Expert scientific judgment and cancer risk assessment: a pilot study of pharmacokinetic data.

PubMed

Hawkins, N C; Graham, J D

1988-12-01

When high-dose tumor data are extrapolated to low doses, it is typically assumed that the dose of a carcinogen delivered to target cells is proportional to the dose administered to test animals, even at exposure levels below the experimental range. Since pharmacokinetic data are becoming available that in some cases question the validity of this assumption, risk assessors must decide whether to maintain the standard assumption. A pilot study of formaldehyde is reported that was undertaken to demonstrate how expert scientific judgment can help guide a controversial risk assessment where pharmacokinetic data are considered inconclusive. Eight experts on pharmacokinetic data were selected by a formal procedure, and each was interviewed personally using a structured interview protocol. The results suggest that expert scientific opinion is polarized in this case, a situation that risk assessors can respond to with a range of risk characterizations considered biologically plausible by the experts. Convergence of expert opinion is likely in this case of several specific research strategies ar executed in a competent fashion. Elicitation of expert scientific judgment is a promising vehicle for evaluating the quality of pharmacokinetic data, expressing uncertainty in risk assessment, and fashioning a research agenda that offers possible forging of scientific consensus.

Former WWII Fighter Pilot Finds New Home Near Family

MedlinePlus

... Navigation Bar Home Current Issue Past Issues Feature: Senior Living Former WWII Fighter Pilot Finds New Home ... in Kalispell, Mont. Advice On a Move to Senior Living: Investigate your new surroundings. Talk to those ...

Key Performance Indicators for the Assessment of Pediatric Pharmacotherapeutic Guidance

PubMed Central

Barrett, Jeffrey S.; Patel, Dimple; Jayaraman, Bhuvana; Narayan, Mahesh; Zuppa, Athena

2008-01-01

Given the paucity of actual guidance provided for managing pediatric drug therapy, prescribing caregivers must be able to draw on the limited published information in pediatrics and/or guidance provided in adults with some account for expected pediatric response. Guidance for managing drug therapy in children is clearly desirable. Our objectives were to construct key performance indicators (KPIs) for pediatric pharmacotherapy guidance to identify drugs where pharmacotherapy guidance would be most beneficial. A pilot survey to assess variation in caregiver appreciation for pediatric dosing guidance has also been constructed to provide a complementary subjective assessment. Three KPI categories, drug utilization (based on hospital admission and billing data collected from 2001 through 2006), medical need, and guidance outcome value along with a KPI composite score have been proposed. Low scores are favored with respect to prioritization for pharmacotherapy guidance. The pilot survey consisted of 15 questions to assess 1) physician knowledge regarding dosing guidance, 2) attitudes toward dose modification and patient individualization, 3) the accessibility, ease of use and appropriateness of existing data stores, and 4) frequency of dosing modification, consultation of dosing compendiums and estimate of success rate in dosing guidance. Pilot results suggest that dosing guidance is generally viewed as important and that the existing resources are insufficient to guide recommendations for all drugs. While the majority of respondents check more than one resource less than 25% of the time, at least 25% of the respondents check more than one resource 25–50% of the time. The majority viewed the relevance of dosing guidance very important to the management of drug therapy. The questionnaire is being extended to the primary care centers, the Kids First Network and specialty care centers. Results will guide the development of decision support systems (DSS) that provide patient-specific pharmacotherapy guidance as part of our pediatric knowledgebase initiative. For the top 25 most utilized agents at our institution over the last 6 years, KPI score ranged from 35 (dexamethasone) to 77 (cefazolin and ampicillin) with an average score of 55. Prototype DSS for tacrolimus and methotrexate are strongly supported by the KPI scoring which ranks their selection in the top 5% of drugs on formulary. KPI metrics provide an objective means of ranking agents for which pediatric pharmacotherapeutic guidance is clearly needed. PMID:23055875

Key performance indicators for the assessment of pediatric pharmacotherapeutic guidance.

PubMed

Barrett, Jeffrey S; Patel, Dimple; Jayaraman, Bhuvana; Narayan, Mahesh; Zuppa, Athena

2008-07-01

Given the paucity of actual guidance provided for managing pediatric drug therapy, prescribing caregivers must be able to draw on the limited published information in pediatrics and/or guidance provided in adults with some account for expected pediatric response. Guidance for managing drug therapy in children is clearly desirable. Our objectives were to construct key performance indicators (KPIs) for pediatric pharmacotherapy guidance to identify drugs where pharmacotherapy guidance would be most beneficial. A pilot survey to assess variation in caregiver appreciation for pediatric dosing guidance has also been constructed to provide a complementary subjective assessment. Three KPI categories, drug utilization (based on hospital admission and billing data collected from 2001 through 2006), medical need, and guidance outcome value along with a KPI composite score have been proposed. Low scores are favored with respect to prioritization for pharmacotherapy guidance. The pilot survey consisted of 15 questions to assess 1) physician knowledge regarding dosing guidance, 2) attitudes toward dose modification and patient individualization, 3) the accessibility, ease of use and appropriateness of existing data stores, and 4) frequency of dosing modification, consultation of dosing compendiums and estimate of success rate in dosing guidance. Pilot results suggest that dosing guidance is generally viewed as important and that the existing resources are insufficient to guide recommendations for all drugs. While the majority of respondents check more than one resource less than 25% of the time, at least 25% of the respondents check more than one resource 25-50% of the time. The majority viewed the relevance of dosing guidance very important to the management of drug therapy. The questionnaire is being extended to the primary care centers, the Kids First Network and specialty care centers. Results will guide the development of decision support systems (DSS) that provide patient-specific pharmacotherapy guidance as part of our pediatric knowledgebase initiative. For the top 25 most utilized agents at our institution over the last 6 years, KPI score ranged from 35 (dexamethasone) to 77 (cefazolin and ampicillin) with an average score of 55. Prototype DSS for tacrolimus and methotrexate are strongly supported by the KPI scoring which ranks their selection in the top 5% of drugs on formulary. KPI metrics provide an objective means of ranking agents for which pediatric pharmacotherapeutic guidance is clearly needed.

Spinal Pain and Occupational Disability: A Cohort Study of British Apache AH Mk1 Pilots

DTIC Science & Technology

2013-09-01

back pain demonstrate a positive association, but a clear dose-response relationship is weak (Lings and Leboeuf-Yde, 2000; Bovenzi and Hulshof , 1999...by aircraft and mode of flight (Kasin et al., 2011; Bongers, Hulshof , Dukstra, and Boshuizen, 1990; Delahaye, Auffret, Metges, Poirier, and Vettes...four-view radiographs of 732 military pilots. Aviation, Space, and Environmental Medicine. 75(2): 154-157. Bongers, P. M., Hulshof , C. T. J

Ramadan fasting and diabetes: an observational study among Turkish migrants in Belgium.

PubMed

Peeters, Bart; Mehuys, Els; Van Tongelen, Inge; Van Bever, Elien; Bultereys, Lore; Avonts, Dirk; Yıldız, Güven; Remon, Jean Paul; Boussery, Koen

2012-12-01

To investigate (i) Ramadan participation, (ii) provision of Ramadan-related advice by healthcare providers, (iii) medication use during Ramadan fasting among Turkish migrants with diabetes in Belgium. This pilot observational study was conducted among a convenience sample of 52 Turkish migrants with diabetes in Belgium. Two questionnaires collected information on socio-demographic characteristics, diabetes-related characteristics, current hypoglycaemic medication with dosing regimen, participation in the past Ramadan, reasons for (non-)participation, use of hypoglycaemic medication during the past Ramadan, advice from their healthcare providers about fasting during Ramadan and follow-up of this advice. Sixteen patients (31%) had fasted during the past Ramadan. Main reason for Ramadan participation was reinforcement of faith (12/15), while the main reason for non-participation was having diabetes (34/36). About 56% of the study population had received recommendations from their healthcare provider(s) about fasting and diabetes during Ramadan. The most commonly provided advice was not to participate in Ramadan, followed by modification of drug therapy. Only 3 patients ignored the advice of their health professionals. In addition, only 60% of those who actually fasted received recommendations about intake of diabetes medication during the Ramadan. Most fasters continued their medication dose unchanged (87% of OHA users and 80% of the insulin users). This pilot study found a low prevalence of Ramadan fasting among Turkish migrants with diabetes in Belgium. We also found that provision of advice by healthcare providers could be improved. Larger scale studies are warranted to confirm these findings. Copyright © 2012 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.

Cost of opioid-treated chronic low back pain: Findings from a pilot randomized controlled trial of mindfulness meditation-based intervention.

PubMed

Zgierska, Aleksandra E; Ircink, James; Burzinski, Cindy A; Mundt, Marlon P

Opioid-treated chronic low back pain (CLBP) is debilitating, costly, and often refractory to existing treatments. This secondary analysis aims to pilot-test the hypothesis that mindfulness meditation (MM) can reduce economic burden related to opioid-treated CLBP. Twenty-six-week unblinded pilot randomized controlled trial, comparing MM, adjunctive to usual-care, to usual care alone. Outpatient. Thirty-five adults with opioid-treated CLBP (≥30 morphine-equivalent mg/day) for 3 + months enrolled; none withdrew. Eight weekly therapist-led MM sessions and at-home practice. Costs related to self-reported healthcare utilization, medication use (direct costs), lost productivity (indirect costs), and total costs (direct + indirect costs) were calculated for 6-month pre-enrollment and postenrollment periods and compared within and between the groups. Participants (21 MM; 14 control) were 20 percent men, age 51.8 ± 9.7 years, with severe disability, opioid dose of 148.3 ± 129.2 morphine-equivalent mg/d, and individual annual income of $18,291 ± $19,345. At baseline, total costs were estimated at $15,497 ± 13,677 (direct: $10,635 ± 9,897; indirect: $4,862 ± 7,298) per participant. Although MM group participants, compared to controls, reduced their pain severity ratings and pain sensitivity to heat stimuli (p < 0.05), no statistically significant within-group changes or between-group differences in direct and indirect costs were noted. Adults with opioid-treated CLBP experience a high burden of disability despite the high costs of treatment. Although this pilot study did not show a statistically significant impact of MM on costs related to opioid-treated CLBP, MM can improve clinical outcomes and should be assessed in a larger trial with long-term follow-up.

Fibromyalgia symptoms are reduced by low-dose naltrexone: a pilot study.

PubMed

Younger, Jarred; Mackey, Sean

2009-01-01

Fibromyalgia is a chronic pain disorder that is characterized by diffuse musculoskeletal pain and sensitivity to mechanical stimulation. In this pilot clinical trial, we tested the effectiveness of low-dose naltrexone in treating the symptoms of fibromyalgia. Participants completed a single-blind, crossover trial with the following time line: baseline (2 weeks), placebo (2 weeks), drug (8 weeks), and washout (2 weeks). Ten women meeting criteria for fibromyalgia and not taking an opioid medication. Naltrexone, in addition to antagonizing opioid receptors on neurons, also inhibits microglia activity in the central nervous system. At low doses (4.5 mg), naltrexone may inhibit the activity of microglia and reverse central and peripheral inflammation. Participants completed reports of symptom severity everyday, using a handheld computer. In addition, participants visited the lab every 2 weeks for tests of mechanical, heat, and cold pain sensitivity. Low-dose naltrexone reduced fibromyalgia symptoms in the entire cohort, with a greater than 30% reduction of symptoms over placebo. In addition, laboratory visits showed that mechanical and heat pain thresholds were improved by the drug. Side effects (including insomnia and vivid dreams) were rare, and described as minor and transient. Baseline erythrocyte sedimentation rate predicted over 80% of the variance in drug response. Individuals with higher sedimentation rates (indicating general inflammatory processes) had the greatest reduction of symptoms in response to low-dose naltrexone. We conclude that low-dose naltrexone may be an effective, highly tolerable, and inexpensive treatment for fibromyalgia.

TLD postal dose intercomparison for megavoltage units in Poland.

PubMed

Izewska, J; Gajewski, R; Gwiazdowska, B; Kania, M; Rostkowska, J

1995-08-01

The aim of the TLD pilot study was to investigate and to reduce the uncertainties involved in the measurements of absorbed dose and to improve the consistency in dose determination in the regional radiotherapy centres in Poland. The intercomparison was organized by the SSDL. It covered absorbed dose measurements under reference conditions for Co-60, high energy X-rays and electron beams. LiF powder type MT-N was used for the irradiations and read with the Harshaw TLD reader model 2000B/2000C. The TLD system was set up and an analysis of the factors influencing the accuracy of absorbed dose measurements with TL-detectors was performed to evaluate and minimize the measurement uncertainty. A fading not exceeding 2% in 12 weeks was found. The relative energy correction factor did not exceed 3% for X-rays in the range 4-15 MV, and 4% for electron beams between 6 and 20 MeV. A total of 34 beams was checked. Deviation of +/- 3.5% stated and evaluated dose was considered acceptable for photons and +/- 5% for electron beams. The results for Co-60, high energy X-rays and electron beams showed that there were two, three and no centres, respectively, beyond acceptance levels. The sources of errors for all deviations out of this range were thoroughly investigated, discussed and corrected, however two deviations remained unexplained. The pilot study resulted in an improvement of the accuracy and consistency of dosimetry in Poland.

Carotid duplex ultrasound and transcranial Doppler findings in commercial divers and pilots.

PubMed

Dormanesh, Banafshe; Vosoughi, Kia; Akhoundi, Fahimeh H; Mehrpour, Masoud; Fereshtehnejad, Seyed-Mohammad; Esmaeili, Setareh; Sabet, Azin Shafiee

2016-12-01

The risky working environments of divers and pilots, and the possible role of extreme ambient pressure in carotid stenosis, make ischemic stroke an important occupational concern among these professionals. In this study, we aimed to evaluate the association of being exposed to hyperbaric or hypobaric conditions with carotid artery stenosis by comparing common carotid intima-media thickness (CCIMT) and blood flow velocities of cerebral arteries in divers and pilots using carotid duplex ultrasound (CDUS) and transcranial Doppler (TCD). CDUS and transtemporal TCD were performed in 29 divers, 36 pilots and 30 control participants. Medical history, blood pressure, lipid profile and blood sugar were recorded to control the previously well-known risk factors of atherosclerosis. Findings of the CDUS and TCD [including: CCIMT and blood flow velocities of internal carotid artery (ICA), common carotid artery (CCA), and middle cerebral artery (MCA)] of divers and pilots were compared with those of the control group using regression analysis models. Both right and left side CCIMT were significantly higher in divers (P < 0.05) and pilots (P < 0.05) in comparison with the control group. Carotid index [peak systolic velocity (PSV) of ICA/PSV of CCA) of divers and pilots were also higher than the control group. TCD findings were not significantly different between divers, pilots, and the control group. Increased CCIMT and carotid index in diver and pilot groups appear to be suggestive of accelerated atherosclerosis of carotid artery in these occupational groups.

Pilots' monitoring strategies and performance on automated flight decks: an empirical study combining behavioral and eye-tracking data.

PubMed

Sarter, Nadine B; Mumaw, Randall J; Wickens, Christopher D

2007-06-01

The objective of the study was to examine pilots' automation monitoring strategies and performance on highly automated commercial flight decks. A considerable body of research and operational experience has documented breakdowns in pilot-automation coordination on modern flight decks. These breakdowns are often considered symptoms of monitoring failures even though, to date, only limited and mostly anecdotal data exist concerning pilots' monitoring strategies and performance. Twenty experienced B-747-400 airline pilots flew a 1-hr scenario involving challenging automation-related events on a full-mission simulator. Behavioral, mental model, and eye-tracking data were collected. The findings from this study confirm that pilots monitor basic flight parameters to a much greater extent than visual indications of the automation configuration. More specifically, they frequently fail to verify manual mode selections or notice automatic mode changes. In other cases, they do not process mode annunciations in sufficient depth to understand their implications for aircraft behavior. Low system observability and gaps in pilots' understanding of complex automation modes were shown to contribute to these problems. Our findings describe and explain shortcomings in pilot's automation monitoring strategies and performance based on converging behavioral, eye-tracking, and mental model data. They confirm that monitoring failures are one major contributor to breakdowns in pilot-automation interaction. The findings from this research can inform the design of improved training programs and automation interfaces that support more effective system monitoring.

Retrospective cross-sectional pilot study of rifaximin dosing for the prevention of recurrent hepatic encephalopathy.

PubMed

Lyon, Kelsey C; Likar, Eric; Martello, Jay L; Regier, Michael

2017-09-01

Standard treatment for hepatic encephalopathy (HE) includes medications that reduce ammonia and bacterial translocation in the gut. Rifaximin can be used off-label for the reduction of overt HE. The study purpose was to determine efficacy of traditional rifaximin dosing (400 mg three times daily) compared with newer dosing (550 mg twice daily) via readmission rates for the prevention of recurrent HE. This was a retrospective, observational, cross-sectional pilot study conducted in a tertiary medical center. A total of 226 patients 18-89 years of age with documentation of HE via ICD-9 code who started rifaximin therapy while inpatient between April 2009 and June 2014 were evaluated. Data collected included rifaximin dosing, other medications used to treat HE, duration of therapy, time to readmission, and various laboratory values. There were no differences in readmission rates at 30 days, 60 days, or 6 months between treatment groups. Additionally, there was no difference in the odds of readmission between the treatment groups (OR = 0.77, 95% CI: [0.201, 4.365], P = 0.718). Patients had a low overall probability of readmission over the observational period. Based on average wholesale price data, the cost for a 9-day supply of rifaximin for the 400-mg dosing regimen is $952.56 versus $605.16 for the 550-mg dosing regimen. The rifaximin 550-mg dosing strategy should be utilized in hospitalized patients for the prevention of recurrent HE as there was no difference in readmission rate or time to readmission between dosing groups. The 550-mg regimen had a lower acquisition cost for a 9-day duration of treatment in the studied institution. © 2017 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.

Dose-Response Effects of Long-Acting Liquid Methylphenidate in Children with Attention Deficit/Hyperactivity Disorder (ADHD) and Autism Spectrum Disorder (ASD): A Pilot Study

ERIC Educational Resources Information Center

Kim, Soo-Jeong; Shonka, Sophia; French, William P.; Strickland, Jennifer; Miller, Lindsey; Stein, Mark A.

2017-01-01

Attention deficit/hyperactivity disorder (ADHD) symptoms are common in youth with autism spectrum disorders (ASD) and are frequently treated with stimulant medications. Twenty-seven children were randomized to different dose titration schedules, and ADHD symptoms, tolerability, and aberrant behaviors were assessed weekly during a 6-week trial with…

Reliability of Current Biokinetic and Dosimetric Models for Radionuclides: A Pilot Study

DOE Office of Scientific and Technical Information (OSTI.GOV)

Leggett, Richard Wayne; Eckerman, Keith F; Meck, Robert A.

2008-10-01

This report describes the results of a pilot study of the reliability of the biokinetic and dosimetric models currently used by the U.S. Nuclear Regulatory Commission (NRC) as predictors of dose per unit internal or external exposure to radionuclides. The study examines the feasibility of critically evaluating the accuracy of these models for a comprehensive set of radionuclides of concern to the NRC. Each critical evaluation would include: identification of discrepancies between the models and current databases; characterization of uncertainties in model predictions of dose per unit intake or unit external exposure; characterization of variability in dose per unit intakemore » or unit external exposure; and evaluation of prospects for development of more accurate models. Uncertainty refers here to the level of knowledge of a central value for a population, and variability refers to quantitative differences between different members of a population. This pilot study provides a critical assessment of models for selected radionuclides representing different levels of knowledge of dose per unit exposure. The main conclusions of this study are as follows: (1) To optimize the use of available NRC resources, the full study should focus on radionuclides most frequently encountered in the workplace or environment. A list of 50 radionuclides is proposed. (2) The reliability of a dose coefficient for inhalation or ingestion of a radionuclide (i.e., an estimate of dose per unit intake) may depend strongly on the specific application. Multiple characterizations of the uncertainty in a dose coefficient for inhalation or ingestion of a radionuclide may be needed for different forms of the radionuclide and different levels of information of that form available to the dose analyst. (3) A meaningful characterization of variability in dose per unit intake of a radionuclide requires detailed information on the biokinetics of the radionuclide and hence is not feasible for many infrequently studied radionuclides. (4) The biokinetics of a radionuclide in the human body typically represents the greatest source of uncertainty or variability in dose per unit intake. (5) Characterization of uncertainty in dose per unit exposure is generally a more straightforward problem for external exposure than for intake of a radionuclide. (6) For many radionuclides the most important outcome of a large-scale critical evaluation of databases and biokinetic models for radionuclides is expected to be the improvement of current models. Many of the current models do not fully or accurately reflect available radiobiological or physiological information, either because the models are outdated or because they were based on selective or uncritical use of data or inadequate model structures. In such cases the models should be replaced with physiologically realistic models that incorporate a wider spectrum of information.« less

Coupled solar photo-Fenton and biological treatment for the degradation of diuron and linuron herbicides at pilot scale.

PubMed

Farré, Maria José; Maldonado, Manuel Ignacio; Gernjak, Wolfgang; Oller, Isabel; Malato, Sixto; Domènech, Xavier; Peral, José

2008-06-01

A coupled solar photo-Fenton (chemical) and biological treatment has been used to remove biorecalcitrant diuron (42 mg l(-1)) and linuron (75 mg l(-1)) herbicides from water at pilot plant scale. The chemical process has been carried out in a 82 l solar pilot plant made up by four compound parabolic collector units, and it was followed by a biological treatment performed in a 40 l sequencing batch reactor. Two Fe(II) doses (2 and 5 mg l(-1)) and sequential additions of H2O2 (20 mg l(-1)) have been used to chemically degrade the initially polluted effluent. Next, biodegradability at different oxidation states has been assessed by means of BOD/COD ratio. A reagent dose of Fe=5 mg l(-1) and H2O2=100 mg l(-1) has been required to obtain a biodegradable effluent after 100 min of irradiation time. Finally, the organic content of the photo-treated solution has been completely assimilated by a biomass consortium in the sequencing batch reactor using a total suspended solids concentration of 0.2 g l(-1) and a hydraulic retention time of 24h. Comparison between the data obtained at pilot plant scale (specially the one corresponding to the chemical step) and previously published data from a similar system performing at laboratory scale, has been carried out.

Assessment of melamine and cyanuric acid toxicity in cats.

PubMed

Puschner, Birgit; Poppenga, Robert H; Lowenstine, Linda J; Filigenzi, Michael S; Pesavento, Patricia A

2007-11-01

The major pet food recall associated with acute renal failure in dogs and cats focused initially on melamine as the suspect toxicant. In the course of the investigation, cyanuric acid was identified in addition to melamine in the offending food. The purpose of this study was to characterize the toxicity potential of melamine, cyanuric acid, and a combination of melamine and cyanuric acid in cats. In this pilot study, melamine was added to the diet of 2 cats at 0.5% and 1%, respectively. Cyanuric acid was added to the diet of 1 cat at increasing doses of 0.2%, 0.5%, and 1% over the course of 10 days. Melamine and cyanuric acid were administered together at 0%, 0.2%, 0.5%, and 1% to 1 cat per dose group. No effect on renal function was observed in cats fed with melamine or cyanuric acid alone. Cats dosed with a combination were euthanized at 48 hours after dosing because of acute renal failure. Urine and touch impressions of kidneys from all cats dosed with the combination revealed the presence of fan-shaped, birefringent crystals. Histopathologic findings were limited to the kidneys and included crystals primarily within tubules of the distal nephron, severe renal interstitial edema, and hemorrhage at the corticomedullary junction. The kidneys contained estimated melamine concentrations of 496 to 734 mg/kg wet weight and estimated cyanuric acid concentrations of 487 to 690 mg/kg wet weight. The results demonstrate that the combination of melamine and cyanuric acid is responsible for acute renal failure in cats.

Brief report: Moving prevention into schools: The impact of a trauma-informed school-based intervention.

PubMed

Mendelson, Tamar; Tandon, S Darius; O'Brennan, Lindsey; Leaf, Philip J; Ialongo, Nicholas S

2015-08-01

Adolescents in disadvantaged communities have high rates of exposure to stress and trauma, which can negatively impact emotion regulation and executive functioning, increasing likelihood of school problems. This pilot study evaluated RAP Club, a 12-session school-based trauma-informed group intervention co-facilitated by a mental health counselor and young adult community member that utilizes evidence-based cognitive-behavioral and mindfulness strategies. Seventh and eighth graders at two urban public schools serving low-income communities were assigned to receive RAP Club (n = 29) or regular school programming (n = 20). RAP Club improved teacher-rated emotion regulation, social and academic competence, classroom behavior, and discipline. Higher program dose predicted improvements in several teacher-rated outcomes. Student self-report outcomes, however, did not vary by study group or dose. Even students with low baseline depression showed improvement in teacher-rated outcomes following program participation, supporting a model of universal program delivery to all students. Findings suggest RAP Club merits further study. Copyright © 2015 The Foundation for Professionals in Services for Adolescents. Published by Elsevier Ltd. All rights reserved.

A comparison between r-LH and urinary supplements containing LH activity in patients undergoing the microdose GnRH agonist flare protocol for in-vitro fertilization: a pilot study.

PubMed

Shavit, Tal; Agdi, Mohammed; Son, Weon Y; Hasson, Josseph; Dahan, Michael H

2016-08-01

The aim of this study was to compare pregnancy rates and stimulation parameters in patients with diminished ovarian reserve, who were treated with recombinant human luteinizing hormone (r-LH) or menopausal gonadotropins (hMG), as part of a microdose flare protocol. A retrospective cohort study was performed. Comparisons between the group that was stimulated with r-LH plus follicle stimulating hormone (FSH) to those treated with hMG and FSH, were performed. Measurements included: medication doses, number of oocyte collected, number of embryos obtained, pregnancy and clinical pregnancy rates. Patients in the r-LH group (N.=40) had significant higher clinical pregnancy rates (33% vs. 14%; P=0.04) and used lower dose of LH (1938 IU vs. 2807 IU; P=0.02) compared to patients that were stimulated with hMG (N.=39). r-LH may offer advantages for the treatment of diminished ovarian reserve when performing a microdose flare protocol when compared to hMG. Both larger and prospective studies should be carried out to confirm these findings.

Evaluation of a New Equation for Calculating the Maximum Wait Time for Pilots That Have Used an Impairing Medication

DTIC Science & Technology

2013-08-01

were treating pre-existing medical conditions using over-the-counter (OTC) medications ( Aspirin ™, Tylenol™, antihistamines, etc.), provided blood...time would decrease to 45 hours for a 150-lb person taking the same dose; a 300 -lb individual taking a 25-mg dose would only need to wait 31 hours...If the 300 -lb person mentioned above had taken a 50- mg dose, the wait time would have been 45 hours, which is approximately the same as the 49

Low-dose aspirin in polycythaemia vera: a pilot study. Gruppo Italiano Studio Policitemia (GISP).

PubMed

1997-05-01

In this pilot study, aimed at exploring the feasibility of a large-scale trial of low-dose aspirin in polycythaemia vera (PV), 112 PV patients (42 females, 70 males. aged 17-80 years) were selected for not having a clear indication for, or contraindication to, aspirin treatment and randomized to receive oral aspirin (40 mg/d) or placebo. Follow-up duration was 16 +/- 6 months. Measurements of thromboxane A2 production during whole blood clotting demonstrated complete inhibition of platelet cyclooxygenase activity in patients receiving aspirin. Aspirin administration was not associated with any bleeding complication. Within the limitations of the small sample size, this study indicates that a biochemically effective regimen of antiplatelet therapy is well tolerated in patients with polycythaemia vera and that a large-scale placebo-controlled trial is feasible.

A comparison of postmortem coronary atherosclerosis findings in general aviation pilot fatalities.

DOT National Transportation Integrated Search

1985-08-01

Autopsy reports of 710 pilots involved in fatal general aviation accidents and received by the FAA for the years 1980-82 were reviewed to appraise the age-specific prevalence of coronary atherosclerosis among the autopsied group and compare findings ...

Postmortem coronary atherosclerosis findings in general aviation accident pilot fatalities : 1975 - 1977.

DOT National Transportation Integrated Search

1980-02-01

Autopsy reports of 710 pilots involved in fatal general aviation accidents and received by the FAA for the years 1980-82 were reviewed to appraise the age-specific prevalence of coronary atherosclerosis among the autopsied group and compare findings ...

[Correction of the functional state of deck aviation pilots by the course of inhalation of therapeutic doses of xenon during long march].

PubMed

Bubeev, Iu A; Kal'manov, A S; Kotrovskaia, T I

2011-01-01

The article deals with efficiency of the course of O2-Xe inhalation for correction of the functional state of deck aviation pilots in a long march. The course was shown to stabilize vagosympathetic balance in organism, to compensate functioning and to retain reserve of the cardiovascular system that resulted in significant psychoemotional animation attested by self-appreciation, amelioration and cheerfulness, and weakening of reactive anxiety. These observations point to applicability of xenon-based gas mixtures to correction of the pilot's functional state in the most intensive periods of service. Guidelines for broad adoption of the method by military medicine have been developed.

Particle effects on ultraviolet disinfection of coliform bacteria in recycled water.

PubMed

Jolis, D; Lam, C; Pitt, P

2001-01-01

Pilot- and bench-scale coliform inactivation tests with UV irradiation were used to show how suspended solids remaining in filtered secondary effluent affect the efficiency of the UV disinfection process. Observed kinetic inactivation rates decreased with increasing suspended particle sizes of 7 microm or larger present in tertiary effluent. First-order inactivation rates estimated from collimated beam dose-response curves for discrete ranges of UV doses were substantially different, which should caution researchers not to compare inactivation data obtained with largely dissimilar UV doses or suspended particle distributions. A dose of approximately 800 J/m2 was identified as the minimum dose that will consistently meet the California wastewater reclamation coliform criterion when applied to in-line filtration effluent.

Achieving Consistent Multiple Daily Low-Dose Bacillus anthracis Spore Inhalation Exposures in the Rabbit Model

PubMed Central

Barnewall, Roy E.; Comer, Jason E.; Miller, Brian D.; Gutting, Bradford W.; Wolfe, Daniel N.; Director-Myska, Alison E.; Nichols, Tonya L.; Taft, Sarah C.

2012-01-01

Repeated low-level exposures to biological agents could occur before or after the remediation of an environmental release. This is especially true for persistent agents such as B. anthracis spores, the causative agent of anthrax. Studies were conducted to examine aerosol methods needed for consistent daily low aerosol concentrations to deliver a low-dose (less than 106 colony forming units (CFU) of B. anthracis spores) and included a pilot feasibility characterization study, acute exposure study, and a multiple 15 day exposure study. This manuscript focuses on the state-of-the-science aerosol methodologies used to generate and aerosolize consistent daily low aerosol concentrations and resultant low inhalation doses to rabbits. The pilot feasibility characterization study determined that the aerosol system was consistent and capable of producing very low aerosol concentrations. In the acute, single day exposure experiment, targeted inhaled doses of 1 × 102, 1 × 103, 1 × 104, and 1 × 105 CFU were used. In the multiple daily exposure experiment, rabbits were exposed multiple days to targeted inhaled doses of 1 × 102, 1 × 103, and 1 × 104 CFU. In all studies, targeted inhaled doses remained consistent from rabbit-to-rabbit and day-to-day. The aerosol system produced aerosolized spores within the optimal mass median aerodynamic diameter particle size range to reach deep lung alveoli. Consistency of the inhaled dose was aided by monitoring and recording respiratory parameters during the exposure with real-time plethysmography. Overall, the presented results show that the animal aerosol system was stable and highly reproducible between different studies and over multiple exposure days. PMID:22919662

SU-E-T-294: Dosimetric Analysis of Planning Phase Using Overlap Volume Histogram for Respiratory Gated Radiotherapy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kang, S; Kim, D; Kim, T

2015-06-15

Purpose: End-of-exhale (EOE) phase is generally preferred for gating window because tumor position is more reproducible. However, other gating windows might be more appropriate for dose distribution perspective. In this pilot study, we proposed to utilize overlap volume histogram (OVH) to search optimized gating window and demonstrated its feasibility. Methods: We acquired 4DCT of 10 phases for 3 lung patients (2 with a target at right middle lobe and 1 at right upper lobe). After structures were defined in every phase, the OVH of each OAR was generated to quantify the three dimensional spatial relationship between the PTV and OARsmore » (bronchus, esophagus, heart and cord etc.) at each phase. OVH tells the overlap volume of an OAR according to outward distance from the PTV. Relative overlap volume at 20 mm outward distance from the PTV (ROV-20) was also defined as a metric for measuring overlap volume and obtained. For dose calculation, 3D CRT plans were made for all phases under the same beam angles and objectives (e.g., 95% of the PTV coverage with at least 100% of the prescription dose of 50 Gy). The gating window phase was ranked according to ROV-20, and the relationship between the OVH and dose distribution at each phase was evaluated by comparing the maximum dose, mean dose, and equivalent uniform dose of OAR. Results: OVHs showed noticeable difference from phase to phase, implying it is possible to find optimal phases for gating window. For 2 out of 3 patients (both with a target at RML), maximum dose, mean dose, and EUD increased as ROV-20 increased. Conclusion: It is demonstrated that optimal phases (in dose distribution perspective) for gating window could exist and OVH can be a useful tool for determining such phases without performing dose optimization calculations in all phases. This work was supported by the Radiation Technology R&D program (No. 2013M2A2A7043498) and the Mid-career Researcher Program (2012-007883) through the National Research Foundation (NRF) funded by the Ministry of Science, ICT & Future Planning (MSIP) of Korea.« less

Successful Proof of Concept of Family Planning and Immunization Integration in Liberia

PubMed Central

Cooper, Chelsea M; Fields, Rebecca; Mazzeo, Corinne I; Taylor, Nyapu; Pfitzer, Anne; Momolu, Mary; Jabbeh-Howe, Cuallau

2015-01-01

ABSTRACT Globally, unmet need for postpartum family planning remains high, while immunization services are among the most wide-reaching and equitable interventions. Given overlapping time frames, integrating these services provides an opportunity to leverage existing health visits to offer women more comprehensive services. From March through November 2012, Liberia's government, with support from the Maternal and Child Health Integrated Program (MCHIP), piloted an integrated family planning and immunization model at 10 health facilities in Bong and Lofa counties. Vaccinators provided mothers bringing infants for routine immunization with targeted family planning and immunization messages and same-day referrals to co-located family planning services. In February 2013, we compared service statistics for family planning and immunization during the pilot against the previous year's statistics. We also conducted in-depth interviews with service providers and other personnel and focus group discussions with clients. Results showed that referral acceptance across the facilities varied from 10% to 45% per month, on average. Over 80% of referral acceptors completed the family planning visit that day, of whom over 90% accepted a contraceptive method that day. The total number of new contraceptive users at participating facilities increased by 73% in Bong and by 90% in Lofa. Women referred from immunization who accepted family planning that day accounted for 44% and 34% of total new contraceptive users in Bong and Lofa, respectively. In Lofa, pilot sites administered 35% more Penta 1 and 21% more Penta 3 doses during the pilot period compared with the same period of the previous year, while Penta 1 and Penta 3 administration decreased in non-pilot facilities. In Bong, there was little difference in the number of Penta 1 and Penta 3 doses administered between pilot and non-pilot facilities. In both counties, Penta 1 to Penta 3 dropout rates increased at pilot sites but not in non-pilot facilities, possibly due to higher than average background dropout rates at pilot sites prior to the intervention in Lofa and the disproportionate effect of data from 1 large facility in Bong. The project provided considerable basic support to assess this proof of concept. However, results suggest that introducing a simple model that is minimally disruptive to existing immunization service delivery can facilitate integration. The model is currently being scaled-up to other counties in Liberia, which could potentially contribute to increased postpartum contraceptive uptake, leading to longer birth intervals and improved health outcomes for children and mothers. PMID:25745121

A randomised controlled pilot trial to evaluate and optimize the use of anti-platelet agents in the perioperative management in patients undergoing general and abdominal surgery--the APAP trial (ISRCTN45810007).

PubMed

Antolovic, D; Rakow, A; Contin, P; Ulrich, A; Rahbari, N N; Büchler, M W; Weitz, J; Koch, M

2012-02-01

Surgeons are increasingly confronted by patients on long-term low-dose acetylsalicylic acid (ASA). However, owing to a lack of evidence-based data, a widely accepted consensus on the perioperative management of these patients in the setting of non-cardiac surgery has not yet been reached. Primary objective was to evaluate the safety of continuous versus discontinuous use of ASA in the perioperative period in elective general or abdominal surgery. Fifty-two patients undergoing elective cholecystectomy, inguinal hernia repair or colonic/colorectal surgery were recruited to this pilot study. According to cardiological evaluation, non-high-risk patients who were on long-term treatment with low-dose ASA were eligible for inclusion. Patients were allocated randomly to continuous use of ASA or discontinuation of ASA intake for 5 days before until 5 days after surgery. The primary outcome was the incidence of major haemorrhagic and thromboembolic complications within 30 days after surgery. A total of 26 patients were allocated to each study group. One patient (3.8%) in the ASA continuation group required re-operation due to post-operative haemorrhage. In neither study group, further bleeding complications occurred. No clinically apparent thromboembolic events were reported in the ASA continuation and the ASA discontinuation group. Furthermore, there were no significant differences between both study groups in the secondary endpoints. Perioperative intake of ASA does not seem to influence the incidence of severe bleeding in non-high-risk patients undergoing elective general or abdominal surgery. Further, adequately powered trials are required to confirm the findings of this study.

Pretreatment with myo-inositol in non polycystic ovary syndrome patients undergoing multiple follicular stimulation for IVF: a pilot study.

PubMed

Lisi, Franco; Carfagna, Piero; Oliva, Mario Montanino; Rago, Rocco; Lisi, Rosella; Poverini, Roberta; Manna, Claudio; Vaquero, Elena; Caserta, Donatella; Raparelli, Valeria; Marci, Roberto; Moscarini, Massimo

2012-07-23

Aim of this pilot study is to examine the effects of myo-inositol administration on ovarian response and oocytes and embryos quality in non PolyCystic Ovary Syndrome (PCOS) patients undergoing multiple follicular stimulation and in vitro insemination by conventional in vitro fertilization or by intracytoplasmic sperm injection. One hundred non-PCOS women aged <40 years and with basal FSH <10 mUI/ml were down-regulated with triptorelin acetate from the mid-luteal phase for 2 weeks, before starting the stimulation protocol for oocytes recovery. All patients received rFSH, at a starting dose of 150 IU for 6 days. The dose was subsequently adjusted according to individual response. Group B (n=50) received myo-inositol and folic acid for 3 months before the stimulation period and then during the stimulation itself. Group A (n-50) received only folic acid as additional treatment in the 3 months before and through treatment. Total length of the stimulation was similar between the two groups. Nevertheless, total amount of gonadotropins used to reach follicular maturation was found significantly lower in group B. In addition, the number of oocytes retrieved was significantly reduced in the group pretreated with myo-inositol. Clinical pregnancy and implantation rate were not significantly different in the two groups. Our findings suggest that the addition of myo-inositol to folic acid in non PCOS-patients undergoing multiple follicular stimulation for in-vitro fertilization may reduce the numbers of mature oocytes and the dosage of rFSH whilst maintaining clinical pregnancy rate. Further, a trend in favor of increased incidence of implantation in the group pretreated with myo-inositol was apparent in this study. Further investigations are warranted to clarify this pharmacological approach, and the benefit it may hold for patients.

Neuroplastic Response After Radiation Therapy for Pediatric Brain Tumors: A Pilot Study

DOE Office of Scientific and Technical Information (OSTI.GOV)

Armstrong, Carol L., E-mail: armstrongc@email.chop.edu; Fisher, Michael J.; Li, Yimei

Purpose: Clinically effective measurement of cognitive toxicity from photon radiation therapy (XRT) should be accurate, sensitive, and specific. This pilot study tested translational findings on phasic changes in children's memory systems that are sensitive and insensitive to toxic XRT effects to identify a possible neuroplastic effect. Methods and Materials: Memory processes were prospectively tested before XRT and at 3 later time points up to 2 years in 35 children with mixed primary brain tumors who had not experienced recurrence. Memory processes were verbal-semantic, visual-semantic, and visual-perceptual, including accuracy, speed to recall, encoding, retrieval, and recognition. The mixed-effects model included time (tomore » estimate slope), covariates (age, tumor locus, XRT field, and medications) as fixed effects, and individual random intercepts. A sensitivity analysis examined the influence of XRT dose to the hippocampi on memory. Results: Retrieval from long-term verbal-semantic memory declined 2 months after completing XRT, as seen in adults, and was lowest at 1 year, which was delayed in comparison with adults. Double dissociation from visual-perceptual memory at baseline and 2 months was found, consistent with adults. Recovery was demonstrated 2 years after XRT. Patterns were unchanged when dose to hippocampus was included in the model. Conclusions: Verbal and semantic long-term retrieval is specifically sensitive to XRT-related cognitive dysfunction, without effect on visual-perceptual memory. Children reached nadir in XRT-sensitive memory 1 year after XRT and recovered by 2 years, which is later than that observed in adults. The protracted period of post-XRT injury may represent the maturation of the human hippocampus and white matter into late adolescence.« less

Combined treatment with memantine/es-citalopram for older depressed patients with cognitive impairment: a pilot study.

PubMed

Pelton, Gregory H; Harper, Oliver L; Roose, Steven P; Marder, Karen; D'Antonio, Kristina; Devanand, D P

2016-06-01

The objective of the study is to assess combined antidepressant and memantine treatment in older patients presenting with depression and cognitive impairment. Thirty-five depressed patients with cognitive impairment participated in this open-label pilot study. We evaluated whether, over a 48-week period, combined antidepressant (primarily es-citalopram) and memantine treatment was effective in the treatment of cognitive impairment and depression. Neuropsychological testing was performed, and antidepressant response monitored at baseline and at the 12, 24, and 48-week time points. Treatment with escitalopram (mean daily dose 18.62 mg, SD 5.15) and memantine (mean daily dose 13.62 mg, SD 6.67) was associated with improvement in Hamilton Depression Rating Scale scores over the 48-week study period. Patients demonstrated significant improvement in the primary outcome of cognitive performance (Selective Reminding Test total immediate recall; SRT-IR) over the 48-week treatment period (p = 0.0147). Significant improvement was also observed in measures of naming and verbal fluency but not in the other cognitive domains. One of the 35 patients (2.9%) converted to Alzheimer's disease over the 48-week treatment period. In the amnestic mild cognitive impairment subsample (n = 22), the conversion rate was 4.5%, a rate lower than in other reports of patients with DEP-CI. In this open-label trial, combined antidepressant and memantine treatment in patients with DEP-CI was associated with improved cognition and a low rate of conversion to dementia compared with published studies in patients with DEP-CI. Although limited by the open-label study design that incorporates practice effects that can improve cognitive test performance, the findings suggest the need for a larger randomized placebo-controlled trial. Copyright © 2015 John Wiley & Sons, Ltd.

The influence of total flight time, recent flight time and age on pilot accident rates

DOT National Transportation Integrated Search

1983-06-30

This paper presents initial finding from a research effort conducted for the Safety Analysis Dvision, Office of Aviation Safety, Federal Aviation Administration (FAA). The analysis considers the influence of recent pilot flight time, total pilot flig...

Agricultural aviation versus other general aviation : toxicological findings in fatal accidents.

DOT National Transportation Integrated Search

1978-09-01

Results from the toxicological study of samples from 174 pilots killed while engaged in aerial application and samples from 2,449 other general aviation pilots are compared. The incidence of alcohol in specimens was similar for ag pilots and other ge...

Dose-Response Effects of Long-Acting Liquid Methylphenidate in Children with Attention Deficit/Hyperactivity Disorder (ADHD) and Autism Spectrum Disorder (ASD): A Pilot Study.

PubMed

Kim, Soo-Jeong; Shonka, Sophia; French, William P; Strickland, Jennifer; Miller, Lindsey; Stein, Mark A

2017-08-01

Attention deficit/hyperactivity disorder (ADHD) symptoms are common in youth with autism spectrum disorders (ASD) and are frequently treated with stimulant medications. Twenty-seven children were randomized to different dose titration schedules, and ADHD symptoms, tolerability, and aberrant behaviors were assessed weekly during a 6-week trial with long-acting liquid methylphenidate (MPH). MPH at low to moderate doses was effective in reducing ADHD symptoms and was well tolerated in young children with ASD and ADHD. Future studies are needed to assess generalization and maintenance of efficacy.

Adjunctive low-dose docosahexaenoic acid (DHA) for major depression: An open-label pilot trial.

PubMed

Smith, Deidre J; Sarris, Jerome; Dowling, Nathan; O'Connor, Manjula; Ng, Chee H

2018-04-01

Whilst the majority of evidence supports the adjunctive use of eicosapentaenoic acid (EPA) in improving mood, to date no study exists using low-dose docosahexaenoic acid (DHA) alone as an adjunctive treatment in patients with mild to moderate major depressive disorder (MDD). A naturalistic 8-week open-label pilot trial of low-dose DHA, (260 mg or 520 mg/day) in 28 patients with MDD who were non-responsive to medication or psychotherapy, with a Hamilton Depression Rating Scale (HAM-D) score of greater than 17, was conducted. Primary outcomes of depression, clinical severity, and daytime sleepiness were measured. After 8 weeks, 54% of patients had a ≥50% reduction on the HAM-D, and 45% were in remission (HAM-D ≤ 7). The eta-squared statistic (0.59) indicated a large effect size for the reduction of depression (equivalent to Cohen's d of 2.4). However confidence in this effect size is tempered due to the lack of a placebo. The mean score for the Clinical Global Impression Severity Scale was significantly improved by 1.28 points (P < 0.05). Despite a significant reduction in the HAM-D score for middle insomnia (P = 0.02), the reduction in excessive daytime somnolence on the total Epworth Sleepiness Scale (ESS) did not reach significance. No significant adverse reactions to DHA were found. Within the major limits of this open-label pilot study, the results suggest that DHA may provide additional adjunctive benefits in patients with mild- to -moderate depression.

Pilot Research as Advocacy: The Case of Sayana Press in Kinshasa, Democratic Republic of the Congo

PubMed Central

Binanga, Arsene; Bertrand, Jane T

2016-01-01

ABSTRACT In the Democratic Republic of the Congo (DRC), the Ministry of Health authorizes only physicians and nurses to give injections, with one exception—medical and nursing students may also give injections if supervised by a clinical instructor. The emergence of the injectable contraceptive Sayana Press in some African countries prompted the DRC to test the acceptability and feasibility of distributing Sayana Press and other contraceptive methods at the community level through medical and nursing students. Sayana Press is similar in formulation to the injectable contraceptive Depo-Provera but contains a lower dose and is administered subcutaneously using a single-use syringe with a short needle called the Uniject system. The Uniject system allows Sayana Press to be administered by community health workers without clinical training or by self-injection. In this pilot, the advocacy objective was to obtain approval from the Ministry of Health to allow medical and nursing students to inject Sayana Press, as a first step toward authorization for community health workers to provide the method. The pilot described in this article documents a process whereby an innovative approach moved from concept to implementation to replication in less than 2 years. It also paved the way for testing additional progressive strategies to increase access to contraception at the community level. Because the pilot project included a research component designed to assess benefits and challenges, it provided the means to introduce the new task-shifting approach, which might not have been approved otherwise. Key pilot activities included: (1) increasing awareness of Sayana Press among family planning stakeholders at a national conference on family planning, (2) enlisting the support of key decision makers in designing the pilot, (3) obtaining marketing authorization to distribute Sayana Press in the DRC, (4) implementing the pilot from July to December 2015, (5) conducting quantitative and qualitative studies to assess acceptability and feasibility, and (6) disseminating the findings to family planning stakeholders. Before the pilot, Sayana Press was relatively unknown in the DRC, and there was no precedent for medical and nursing students providing family planning methods or giving injections at the community level. In less than 12 months, the approach gained legitimacy and acceptance. The key Ministry of Health decision maker orchestrated the closing session of the dissemination meeting on next steps, paving the way for pilot tests of 3 new task-shifting approaches: insertion of Implanon NXT by medical and nursing students, self-injection for Sayana Press with supervision by students, and injection of Sayana Press by community health workers with no formal clinical training. PMID:27979874

Pilot Research as Advocacy: The Case of Sayana Press in Kinshasa, Democratic Republic of the Congo.

PubMed

Binanga, Arsene; Bertrand, Jane T

2016-12-23

In the Democratic Republic of the Congo (DRC), the Ministry of Health authorizes only physicians and nurses to give injections, with one exception-medical and nursing students may also give injections if supervised by a clinical instructor. The emergence of the injectable contraceptive Sayana Press in some African countries prompted the DRC to test the acceptability and feasibility of distributing Sayana Press and other contraceptive methods at the community level through medical and nursing students. Sayana Press is similar in formulation to the injectable contraceptive Depo-Provera but contains a lower dose and is administered subcutaneously using a single-use syringe with a short needle called the Uniject system. The Uniject system allows Sayana Press to be administered by community health workers without clinical training or by self-injection. In this pilot, the advocacy objective was to obtain approval from the Ministry of Health to allow medical and nursing students to inject Sayana Press, as a first step toward authorization for community health workers to provide the method. The pilot described in this article documents a process whereby an innovative approach moved from concept to implementation to replication in less than 2 years. It also paved the way for testing additional progressive strategies to increase access to contraception at the community level. Because the pilot project included a research component designed to assess benefits and challenges, it provided the means to introduce the new task-shifting approach, which might not have been approved otherwise. Key pilot activities included: (1) increasing awareness of Sayana Press among family planning stakeholders at a national conference on family planning, (2) enlisting the support of key decision makers in designing the pilot, (3) obtaining marketing authorization to distribute Sayana Press in the DRC, (4) implementing the pilot from July to December 2015, (5) conducting quantitative and qualitative studies to assess acceptability and feasibility, and (6) disseminating the findings to family planning stakeholders. Before the pilot, Sayana Press was relatively unknown in the DRC, and there was no precedent for medical and nursing students providing family planning methods or giving injections at the community level. In less than 12 months, the approach gained legitimacy and acceptance. The key Ministry of Health decision maker orchestrated the closing session of the dissemination meeting on next steps, paving the way for pilot tests of 3 new task-shifting approaches: insertion of Implanon NXT by medical and nursing students, self-injection for Sayana Press with supervision by students, and injection of Sayana Press by community health workers with no formal clinical training. © Binanga and Bertrand.

Evaluation of a new equation for calculating the maximum wait time for pilots that have used an impairing medication.

DOT National Transportation Integrated Search

2013-08-01

Pilots thatuse an impairing medication to treat a medicalcondition are required to wait an appropriate amount of time after completing the treatment before returning to duty.However, toxicology findings for pilots involved in fatal aviation accidents...

Effect of ketotifen premedication on adverse reactions during peanut oral immunotherapy

PubMed Central

2014-01-01

Background Oral immunotherapy (OIT) has shown promise in inducing desensitization for food allergy. However, there are safety concerns regarding the frequency and severity of adverse events during food OIT. Objective To evaluate the effect of Ketotifen premedication on adverse reactions during peanut OIT. Methods A randomized single blind placebo controlled pilot study was performed. Peanut OIT was performed using a previously published protocol. Ketotifen was up-titrated to 2 mg twice daily over two weeks (week -2 to 0), followed by a peanut OIT initial escalation day (day 1). Ketotifen was administered from week 0–4 of peanut OIT; reactions to peanut OIT doses were recorded by clinic staff and subject diary. Results Six subjects (median age 10 years, peanut IgE >100kUA/L) were enrolled, 4 randomized to Ketotifen, 2 to placebo. The most common side effect of Ketotifen was fatigue (9% during up-titration). The rate of reaction per peanut OIT dose was lower for subjects on ketotifen (K) compared to placebo (P) during initial escalation on day 1 (K: 22% (8/36) vs. P: 67% (12/18)); week 0–4 build-up doses (K: 75% (3/4) vs. P: 100% (2/2)); and week 0–4 home doses (K: 50% (54/108) vs. P: 82% (27/33)). The rate of gastrointestinal symptoms per peanut OIT dose was also lower for subjects on ketotifen during initial escalation on day 1 (K: 17% (6/36) vs. P: 61% (11/18)); week 0–4 build-up doses (K: 75% (3/4) vs P: 100% (2/2)); and week 0–4 home doses (K: 46% (50/108) vs. P: 82% (27/33)). Conclusions Ketotifen premedication is well tolerated and reduces the rate of gastrointestinal symptoms during peanut OIT. These findings require confirmation in a larger study of Ketotifen premedication used throughout peanut OIT. Trial registration Clinical Trials number: NCT0162515 PMID:25031584

Cardiorespiratory assessment of decongestant-antihistamine effects of altitude, +Gz, and fatigue tolerances.

DOT National Transportation Integrated Search

1978-04-01

Decongestants and antihistamines are known to produce effects capable of adversely modifying physiological function and psychomotor task performance. Because of relevance to safe pilot performance, the effects of single doses of two decongestant-anti...

CRYPTOSPORIDIUM INACTIVATION AND REMOVAL RESEARCH

EPA Science Inventory

Bench- and pilot-scale tests were performed to assess the ability of conventional treatment, ozonation and chlorine dioxide to remove and inactivate Cryptosporidium oocysts. The impacts of coagulant type, coagulant dose, raw water quality, filter loading rates and filter media w...

Standard- or high-dose oxytocin for nulliparous women with confirmed delay in labour: quantitative and qualitative results from a pilot randomised controlled trial.

PubMed

Kenyon, S; Armstrong, N; Johnston, T; Walkinshaw, S; Petrou, S; Howman, A; Cheed, V; Markham, C; McNicol, S; Willars, J; Waugh, J

2013-10-01

Evidence suggests that a high dose of oxytocin for nulliparous women at 37-42 weeks of gestation with confirmed delay in labour increases spontaneous vaginal birth. We undertook a pilot study to test the feasibility of this treatment. Pilot double-blind randomised controlled trial. Three teaching hospitals in the UK. A total of 94 consenting nulliparous women at term with confirmed delay in labour were recruited, and 18 were interviewed. Women were assigned to either a standard (2 mU/min, increasing every 30 minutes to 32 mU/minute) or a high-dose regimen (4 mU/minute, increasing every 30 minutes to 64 mU/minutes) oxytocin by computer-generated randomisation. Simple descriptive statistics were used, as the sample size was insufficient to evaluate clinical outcomes. The constant comparative method was used to analyse the interviews. The main outcome measures: number of women eligible; maternal and neonatal birth; safety; maternal psychological outcomes and experiences; health-related quality of life outcomes using validated tools and data on health service resource use; incidence of suspected delay of labour (cervical dilatation of <2 cm after 4 hours, once labour is established); and incidence of confirmed delay of labour (progress of <1 cm on repeat vaginal examination after a period of 2 hours). We successfully developed systems to recruit eligible women in labour and to collect data. Rates of spontaneous vaginal birth (10/47 versus 12/47, RR 1.2, 95% CI 0.6-2.5) and caesarean section (15/47 versus 17/47, RR 1.1, 95% CI 0.6-2.0) were increased, and rates of instrumental birth were reduced (21/47 versus 17/47, RR 0.8, 95% CI 0.5-1.3). No evidence of increased harm for either mother or baby was found. The incidences of suspected delay (14%) and confirmed delay (11%) in labour were less than anticipated. Of those who did not go on to have delayed labour confirmed, all except one woman gave birth vaginally. A pilot trial assessing the efficacy of high-dose oxytocin was feasible, but uncertainty remains, highlighting the need for a large definitive trial. The implementation of national guidance of suspected and confirmed delay in labour is likely to reduce intervention. © 2013 RCOG.

Findings from a Pilot Study into Student Retention beyond Year 10

ERIC Educational Resources Information Center

Cranston, Neil; Allen, Jeanne Maree; Watson, Jane; Hay, Ian; Beswick, Kim

2012-01-01

This paper reports on early findings from a pilot study into student retention beyond Year 10. Located in rural, regional and disadvantaged communities in Tasmania, the research has implications at State, national and international levels. It is being funded by a nationally competitive Australian Research Council Linkage grant and the Tasmanian…

Supporting the Sustainability Journey of Tertiary International Students in Australia

ERIC Educational Resources Information Center

Sidiropoulos, Liz; Wex, Irene; Sibley, Jonathan

2013-01-01

This article reports the findings of a pilot Education for Sustainability (EfS) program implemented in 2011 for international students in a multi-campus distributed learning environment at an Australian university. It outlines the context of the pilot EfS program and reports survey findings of the environmental attitudes and sustainability…

Sub-dissociative dose intranasal ketamine for limb injury pain in children in the emergency department: a pilot study.

PubMed

Yeaman, Fiona; Oakley, Ed; Meek, Robert; Graudins, Andis

2013-04-01

The present study aims to conduct a pilot study examining the effectiveness of intranasal (IN) ketamine as an analgesic for children in the ED. The present study used an observational study on a convenience sample of paediatric ED patients aged 3-13 years, with moderate to severe (≥6/10) pain from isolated limb injury. IN ketamine was administered at enrolment, with a supplementary dose after 15 min, if required. Primary outcome was change in median pain rating at 30 min. Secondary outcomes included change in median pain rating at 60 min, patient/parent satisfaction, need for additional analgesia and adverse events being reported. For the 28 children included in the primary analysis, median age was 9 years (interquartile range [IQR] 6-10). Twenty-three (82.1%) were male. Eighteen (64%) received only one dose of IN ketamine (mean dose 0.84 mg/kg), whereas 10 (36%) required a second dose at 15 min (mean for second dose 0.54 mg/kg). The total mean dose for all patients was 1.0 mg/kg (95% CI: 0.92-1.14). The median pain rating decreased from 74.5 mm (IQR 60-85) to 30 mm (IQR 12-51.5) at 30 min (P < 0.001, Mann-Whitney). For the 24 children who contributed data at 60 min, the median pain rating was 25 mm (IQR 4-44). Twenty (83%) subjects were satisfied with their analgesia. Eight (33%) were given additional opioid analgesia and the 28 reported adverse events were all transient and mild. In this population, an average dose of 1.0 mg/kg IN ketamine provided adequate analgesia by 30 min for most patients. © 2013 The Authors. EMA © 2013 Australasian College for Emergency Medicine and Australasian Society for Emergency Medicine.

Uptake and impact of a new live attenuated influenza vaccine programme in England: early results of a pilot in primary school-age children, 2013/14 influenza season.

PubMed

Pebody, R G; Green, H K; Andrews, N; Zhao, H; Boddington, N; Bawa, Z; Durnall, H; Singh, N; Sunderland, A; Letley, L; Ellis, J; Elliot, A J; Donati, M; Smith, G E; de Lusignan, S; Zambon, M

2014-06-05

As part of the introduction and roll-out of a universal childhood live-attenuated influenza vaccination programme, 4–11 year-olds were vaccinated in seven pilot areas in England in the 2013/14 influenza season. This paper presents the uptake and impact of the programme for a range of disease indicators. End-of-season uptake was defined as the number of children in the target population who received at least one dose of influenza vaccine. Between week 40 2013 and week 15 2014, cumulative disease incidence per 100,000 population (general practitioner consultations for influenza-like illness and laboratory-confirmed influenza hospitalisations), cumulative influenza swab positivity in primary and secondary care and cumulative proportion of emergency department respiratory attendances were calculated. Indicators were compared overall and by age group between pilot and non-pilot areas. Direct impact was defined as reduction in cumulative incidence based on residence in pilot relative to non-pilot areas in 4–11 year-olds. Indirect impact was reduction between pilot and non-pilot areas in <4 year-olds and >11 year-olds. Overall vaccine uptake of 52.5% (104,792/199,475) was achieved. Although influenza activity was low, a consistent, though not statistically significant, decrease in cumulative disease incidence and influenza positivity across different indicators was seen in pilot relative to non-pilot areas in both targeted and non-targeted age groups, except in older age groups, where no difference was observed for secondary care indicators.

Sub-antimicrobial Doxycycline for Periodontitis Reduces Hemoglobin A1c in Subjects with Type 2 Diabetes: a Pilot Study

PubMed Central

Engebretson, Steven P.; Hey-Hadavi, Judith

2011-01-01

In vitro and animal studies suggest a possible role for the tetracycline class of drugs in the inhibition of non-enzymatic protein glycation. We conducted a 3-month, randomized placebo-controlled pilot clinical trial of conventional sub-gingival debridement, (periodontal therapy) combined with either a three month regimen of sub-antimicrobial-dose doxycycline (SDD), a two week regimen of antimicrobial-dose doxycycline (ADD), or placebo in 45 patients with long-standing type 2 diabetes (mean duration 9 years) and untreated chronic periodontitis. Subjects were taking stable doses of oral hypoglycemic medications and/or insulin. Treatment response was assessed by measuring hemoglobin A1c (HbA1c),plasma glucose, and clinical periodontal disease measures. At one-month and three-month follow-up, clinical measures of periodontitis were decreased in all groups(data to be presented elsewhere). At three months, mean HbA1c levels in the SDD group were reduced 0.9% unitsfrom 7.2% units ± 2.2(±SD), to 6.3% units ±1.1, which represents a 12.5% improvement. In contrast, there was no significant change in HbA1c in the ADD (7.5%± 2.0 to 7.8%± 2.1) or placebo (8.5%± 2.0 to 8.5%± 2.6) groups. Mean HbA1c change from baseline was significantly greater in the SDD group compared with the ADD group (p=0.04) but not placebo (p=0.22). Moreover, a larger proportion of subjects in the SDD group experienced improvement (p<0.05) compared to the ADD or placebo groups. Mean plasma glucose levels were not significantly different between or within the groups. The results of this pilot study suggest that the treatment of periodontitis with sub-gingival debridement and 3-months of daily sub-antimicrobial-dose doxycycline may decrease HbA1c in patients with type 2 diabetes taking normally prescribed hypoglycemic agents. PMID:21782948

Preliminary toxicity findings in dogs and rodents given the iron chelator ethylenediamine-N,N'-bis(2-hydroxyphenylacetic acid) (EDHPA).

PubMed

Rosenkrantz, H; Metterville, J J; Fleischman, R W

1986-02-01

Because of a projected pilot study with EDHPA in Cooley's anemia patients, animal studies with emphasis on reversibility of potential toxic signs were performed. Young dogs were treated iv with 6-18 mg/kg or orally with 30-240 mg/kg for 14 days followed by a 16-day recovery period. Drug-induced emesis, elevated BUN changes in kidney, spleen, and thymus weights diminished during recovery. One deceased dog exhibited nephrotoxicity consisting of tubular necrosis and deposition of the iron-EDHPA complex. The latter was observed in the excreta of survivors but kidney damage was not evident. Atrophy of the spleen and thymus in the deceased dog was consistent with less intense organ weight changes in recovered survivors. In the absence of morphologic changes after recovery, the precise effect on the immune system is unknown. The iv LD50 was 53 mg/kg for rats and mice. No rodent deaths occurred at an oral dose of 6000 mg/kg. An elevated BUN and changes in kidney, spleen, and thymus weights were confirmed in rodents given iv doses of 5-20 mg/kg or oral doses of 150-600 mg/kg for 5 days. It is cautioned that during the use of EDHPA derivatives that the functions of the renal and immune systems be monitored.

Achieving Consistent Multiple Daily Low-Dose Bacillus anthracis Spore Inhalation Exposures in the Rabbit Model

DTIC Science & Technology

2012-06-13

plethysmography. Overall, the presented results show that the animal aerosol system was stable and highly reproducible between different studies and over...develop and deliver low-doses of B. anthracis spores via inhalation in a reproducible manner. The pilot feasibility study (see Table 1 for results) enabled...results presented in Figure 3 show that exposures produced by the aerosol system were stable and reproducible from day-to-day. In all testing, the

Linking the Pilot Structural Model and Pilot Workload

NASA Technical Reports Server (NTRS)

Bachelder, Edward; Hess, Ronald; Aponso, Bimal; Godfroy-Cooper, Martine

2018-01-01

Behavioral models are developed that closely reproduced pulsive control response of two pilots using markedly different control techniques while conducting a tracking task. An intriguing find was that the pilots appeared to: 1) produce a continuous, internally-generated stick signal that they integrated in time; 2) integrate the actual stick position; and 3) compare the two integrations to either issue or cease a pulse command. This suggests that the pilots utilized kinesthetic feedback in order to sense and integrate stick position, supporting the hypothesis that pilots can access and employ the proprioceptive inner feedback loop proposed by Hess's pilot Structural Model. A Pilot Cost Index was developed, whose elements include estimated workload, performance, and the degree to which the pilot employs kinesthetic feedback. Preliminary results suggest that a pilot's operating point (parameter values) may be based on control style and index minimization.

Evaluation of empirical process design relationships for ozone disinfection of water and wastewater

DOE Office of Scientific and Technical Information (OSTI.GOV)

Finch, G.R.; Smith, D.W.

A research program was undertaken to examine the dose-response of Escherichia coli ATCC 11775 in ozone demand-free phosphate buffer solution and in a high quality secondary wastewater effluent with a total organic carbon content of 8 mg/L and a chemical oxygen demand of 26 mg/L. The studies were conducted in bench-scale batch reactors for both water types. In addition, studies using secondary effluent also were conducted in a pilot-scale, semi-batch reactor to evaluate scale-up effects. It was found that the ozone dose was the most important design parameter in both types of water. Contact time was of some importance inmore » the ozone demand-free water and had no detectable effect in the secondary effluent. Pilot-scale data confirmed the results obtained at bench-scale for the secondary effluent. Regression analysis of the logarithm of the E. coli response on the logarithm of the utilized ozone dose revealed that there was lack-of-fit using the model form which has been used frequently for the design of wastewater disinfection systems. This occurred as a result of a marked tailing effect of the log-log plot as the ozone dose increased and the kill increased. It was postulated that this was caused by some unknown physiological differences within the E. coli population due to age or another factor.« less

Highly effective reduced toxicity dose-intensive pilot protocol for non-metastatic limb osteogenic sarcoma (SCOS 89).

PubMed

Shkalim-Zemer, Vered; Ash, Shifra; Toledano, Helen; Kollender, Yehuda; Issakov, Josephine; Yaniv, Isaac; Cohen, Ian J

2015-11-01

Aggressive chemotherapy protocols for non-metastatic limb osteosarcoma have improved histological response without affecting prognosis. This study evaluated the toxicity and outcome of a dose-intensive, high-dose 3- to 5-drug pilot protocol, SCOS 89. The cohort included 26 patients (14 male; ages 6.5-22 years) with non-metastatic limb osteosarcoma treated at a tertiary pediatric medical center between 1989 and 2013. Preoperatively, patients received two courses of once-weekly pulses of high-dose methotrexate (12-30 g/m(2)) for 2 weeks; doxorubicin (90 mg/m(2)) with dexrazoxane, combined with cisplatin (200 mg/m(2)), was added in week 3. Following methotrexate, 760 mg/m(2) of folinic acid was administered. Postoperative chemotherapy was continued to a total of 14 courses of methotrexate, doxorubicin (up to a total dose of 360 mg/m(2)), and cisplatin (up to a total dose of 560 mg/m(2)). If toxicity occurred or <90 % tumor necrosis, ifosfamide (12 g/m(2)) plus etoposide (500 mg/m(2)) was substituted for doxorubicin, cisplatin, or methotrexate. Toxicity and death rates were calculated. All patients underwent definitive limb salvage surgery. Six patients died of infection, recurrent disease, or secondary malignancy. Median follow-up was 100 months (range 2-290). Event-free and overall survival rates, respectively, were 88 and 96 % at 2 years, 80 and 87.6 % at 5 years, 80 and 78 % at 10 years. Eleven patients required ifosfamide/etoposide substitution. One patient had a transient decreased left ventricular ejection fraction. Two patients developed acute nephrotoxicity during therapy, but no neurotoxicity. Seven patients had hearing impairment. The SCOS 89 yields a high event-free survival rate with reduced nephro-/neuro-/cardiotoxicity in patients with non-metastatic limb osteosarcoma.

SU-C-202-05: Pilot Study of Online Treatment Evaluation and Adaptive Re-Planning for Laryngeal SBRT

DOE Office of Scientific and Technical Information (OSTI.GOV)

Mao, W; Henry Ford Health System, Detroit, MI; Liu, C

Purpose: We have instigated a phase I trial of 5-fraction stereotactic body radiotherapy (SBRT) for advanced-stage laryngeal cancer. We conducted this pilot dosimetric study to confirm the potential utility of online adaptive re-planning to preserve treatment quality. Methods: Ten cases of larynx cancer were evaluated. Baseline and daily SBRT treatment plans were generated per trial protocol. Daily volumetric images were acquired prior to every fraction of treatment. Reference simulation CT images were deformably registered to daily volumetric images using Eclipse. Planning contours were then deformably propagated to daily images. Reference SBRT plans were directly copied to calculate delivered dose distributionsmore » on deformed reference CT images. In-house software platform has been developed to calculate cumulative dose over a course of treatment in four steps: 1) deforming delivered dose grid to reference CT images using deformation information exported from Eclipse; 2) generating tetrahedrons using deformed dose grid as vertices; 3) resampling dose to a high resolution within every tetrahedron; 4) calculating dose-volume histograms. Our inhouse software was benchmarked with a commercial software, Mirada. Results: In all ten cases including 49 fractions of treatments, delivered daily doses were completely evaluated and treatment could be re-planned within 10 minutes. Prescription dose coverage of PTV was less than intended in 53% of fractions of treatment (mean: 94%, range: 84%–98%) while minimum coverage of CTV and GTV was 94% and 97%, respectively. Maximum bystander point dose limits to arytenoids, parotids, and spinal cord remained respected in all cases, although variances in carotid artery doses were observed in a minority of cases. Conclusion: Although GTV and CTV coverage is preserved by in-room 3D image guidance of larynx SBRT, PTV coverage can vary significantly from intended plans. Online adaptive treatment evaluation and re-planning is potentially necessary and our procedure is clinically applicable to fully preserve treatment quality. This project is supported by CPRIT Individual Investigator Research Award RP150386.« less

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lafata, K; Ren, L; Wu, Q

Purpose: To develop a data-mining methodology based on quantum clustering and machine learning to predict expected dosimetric endpoints for lung SBRT applications based on patient-specific anatomic features. Methods: Ninety-three patients who received lung SBRT at our clinic from 2011–2013 were retrospectively identified. Planning information was acquired for each patient, from which various features were extracted using in-house semi-automatic software. Anatomic features included tumor-to-OAR distances, tumor location, total-lung-volume, GTV and ITV. Dosimetric endpoints were adopted from RTOG-0195 recommendations, and consisted of various OAR-specific partial-volume doses and maximum point-doses. First, PCA analysis and unsupervised quantum-clustering was used to explore the feature-space tomore » identify potentially strong classifiers. Secondly, a multi-class logistic regression algorithm was developed and trained to predict dose-volume endpoints based on patient-specific anatomic features. Classes were defined by discretizing the dose-volume data, and the feature-space was zero-mean normalized. Fitting parameters were determined by minimizing a regularized cost function, and optimization was performed via gradient descent. As a pilot study, the model was tested on two esophageal dosimetric planning endpoints (maximum point-dose, dose-to-5cc), and its generalizability was evaluated with leave-one-out cross-validation. Results: Quantum-Clustering demonstrated a strong separation of feature-space at 15Gy across the first-and-second Principle Components of the data when the dosimetric endpoints were retrospectively identified. Maximum point dose prediction to the esophagus demonstrated a cross-validation accuracy of 87%, and the maximum dose to 5cc demonstrated a respective value of 79%. The largest optimized weighting factor was placed on GTV-to-esophagus distance (a factor of 10 greater than the second largest weighting factor), indicating an intuitively strong correlation between this feature and both endpoints. Conclusion: This pilot study shows that it is feasible to predict dose-volume endpoints based on patient-specific anatomic features. The developed methodology can potentially help to identify patients at risk for higher OAR doses, thus improving the efficiency of treatment planning. R01-184173.« less

Precoagulation-microfiltration for wastewater reuse.

PubMed

Hatt, J W; Germain, E; Judd, S J

2011-12-01

A range of coagulant chemicals and doses, up to 2 mg/L, were trialled on a microfiltration-based indirect potable reuse (IPR) pilot plant to evaluate their impact on membrane reversible and irreversible fouling. Jar tests revealed these doses to have negligible impact on organic matter removal, whilst scoping pilot trials showed them to have a positive impact on fouling rates. Initial trials carried out over a 6-h period suggested that ferric sulphate was the most promising of the coagulants tested with regards to irreversible fouling. Extended five-day trials using ferric sulphate at 0.5 mg/L were conducted at fluxes of 40-50 l/(m(2)h) (LMH). Operation at 50 LMH without coagulant resulted in rapid fouling and a subsequent shortening of the chemical cleaning interval. The addition of the ferric coagulant resulted in a reduction in both reversible and irreversible fouling to those levels experienced at 40 LMH, enabling sustainable operation. The use of low levels of coagulant thus enables the pilot plant to operate at a 25% increased flux, equating to a 20% reduction in membrane area and overall savings of >0.1 p per m(3) for a seven year membrane life. Copyright © 2011 Elsevier Ltd. All rights reserved.

Practical and Scholarly Implications of Information Behaviour Research: A Pilot Study of Research Literature

ERIC Educational Resources Information Center

Koh, Kyungwon; Rubenstein, Ellen; White, Kelvin

2015-01-01

Introduction: This pilot study examined how current information behaviour research addresses the implications and potential impacts of its findings. The goal was to understand what implications and contributions the field has made and how effectively authors communicate implications of their findings. Methods: We conducted a content analysis of 30…

Evidence for oral agmatine sulfate safety--a 95-day high dosage pilot study with rats.

PubMed

Gilad, Gad M; Gilad, Varda H

2013-12-01

Agmatine, decarboxylated arginine, exerts beneficial effects in various experimental disease models. Clinical trials indicate the safety and effectiveness of short-term (up to 21 days) high dose regimens of oral agmatine sulfate, but longer term studies are lacking. This pilot study undertook to assess the safety of a longer term high dosage oral agmatine sulfate in laboratory rats. Adult Wistar rats consumed 5.3 g/l agmatine sulfate in their drinking water for 95 days, a regimen estimated to result in a daily dosage of absorbed agmatine of about 100mg/kg. Animals' body weight, water consumption and blood pressure were periodically measured, and general cage behavior, fur appearance, urination and feces appearance monitored. These parameters were also determined at 20 days after treatment cessation (day 115). On days 95 and 115, animals were euthanized for gross necropsy assessment. Agmatine-treated rats showed slight, but significant reductions in body weight and blood pressure, and reduced water consumption during treatment, which recovered completely within 20 days after treatment cessation. Otherwise, no abnormal behaviors or organ pathologies were observed. These findings are first to suggest apparent safety of sub-chronic high dosage dietary agmatine sulfate in laboratory rats, thus lending further support to the therapeutic applications of agmatine. Copyright © 2013 Elsevier Ltd. All rights reserved.

Promising hypotensive effect of hawthorn extract: a randomized double-blind pilot study of mild, essential hypertension.

PubMed

Walker, Ann F; Marakis, Georgios; Morris, Andrew P; Robinson, Paul A

2002-02-01

This pilot study was aimed at investigating the hypotensive potential of hawthorn extract and magnesium dietary supplements individually and in combination, compared with a placebo. Thirty-six mildly hypertensive subjects completed the study. At baseline, anthropometric and dietary assessment, as well as blood pressure measurements were taken at rest, after exercise and after a computer 'stress' test. Volunteers were then randomly assigned to a daily supplement for 10 weeks of either: (a) 600 mg Mg, (b) 500 mg hawthorn extract, (c) a combination of (a) and (b), (d) placebo. Measurements were repeated at 5 and 10 weeks of intervention. There was a decline in both systolic and diastolic blood pressure in all treatment groups, including placebo, but ANOVA provided no evidence of difference between treatments. However, factorial contrast analysis in ANOVA showed a promising reduction (p = 0.081) in the resting diastolic blood pressure at week 10 in the 19 subjects who were assigned to the hawthorn extract, compared with the other groups. Furthermore, a trend towards a reduction in anxiety (p = 0.094) was also observed in those taking hawthorn compared with the other groups. These findings warrant further study, particularly in view of the low dose of hawthorn extract used. Copyright 2002 John Wiley & Sons, Ltd.

Rasagiline for dysexecutive symptoms during wearing-off in Parkinson's disease: a pilot study.

PubMed

Rinaldi, Domiziana; Assogna, Francesca; Sforza, Michela; Tagliente, Stefania; Pontieri, Francesco E

2018-01-01

Wearing-off refers to the predictable worsening of motor and sometimes non-motor symptoms of Parkinson's disease occurring at the end of levodopa dose that improves with the next drug dose. Here, we investigated the efficacy of rasagiline on executive functions at the end of levodopa dose in patients displaying symptoms of wearing-off. Rasagiline was well-tolerated and produced a significant improvement at the Frontal Assessment Battery, together with improvement of motor symptoms at the end of levodopa dose. These results suggest that treatment of motor symptoms of wearing-off with rasagiline may be accompanied by improvement of executive functions, and further support the need for optimizing dopamine replacement therapy in fluctuating Parkinson's disease patients.

Cost of Opioid-Treated Chronic Low Back Pain: Findings from a Pilot Randomized Controlled Trial of Mindfulness Meditation-Based Intervention

PubMed Central

Ircink, James; Burzinski, Cindy A.; Mundt, Marlon P.

2018-01-01

Objective Opioid-treated chronic low back pain (CLBP) is debilitating, costly and often refractory to existing treatments. This secondary analysis aims to pilot-test the hypothesis that mindfulness meditation (MM) can reduce economic burden related to opioid-treated CLBP. Design 26-week unblinded pilot randomized controlled trial, comparing MM, adjunctive to usual-care, to usual care alone. Setting Outpatient Participants Thirty-five adults with opioid-treated CLBP (≥ 30 morphine-equivalent mg/day) for 3+ months enrolled; none withdrew. Intervention 8 weekly therapist-led MM sessions and at-home practice. Outcome Measures Costs related to self-reported healthcare utilization, medication use (direct costs), lost productivity (indirect costs), and total costs (direct+indirect costs) were calculated for 6-month pre- and post-enrollment periods and compared within and between the groups. Results Participants (21 MM; 14 control) were 20% men, age 51.8 ± 9.7 years, with severe disability, opioid dose of 148.3 ± 129.2 morphine-equivalent mg/day, and individual annual income of $18,291 ± $19,345. At baseline, total costs were estimated at $15,497 ± 13,677 (direct: $10,635 ± 9,897; indirect: $4,862 ± 7,298) per participant. Although MM group participants, compared to controls, reduced their pain severity ratings and pain sensitivity to heat-stimuli (p<0.05), no statistically significant within-group changes or between-group differences in direct and indirect costs were noted. Conclusions Adults with opioid-treated CLBP experience a high burden of disability despite the high costs of treatment. Although this pilot study did not show a statistically significant impact of MM on costs related to opioid-treated CLBP, MM can improve clinical outcomes and should be assessed in a larger trial with long-term follow-up. PMID:28829518

Shockwave treatment for medial tibial stress syndrome: A randomized double blind sham-controlled pilot trial.

PubMed

Newman, Phil; Waddington, Gordon; Adams, Roger

2017-03-01

Up to 35% of runners develop medial tibial stress syndrome (MTSS) which often results in lengthy disruption to training and sometimes affects daily activities. There is currently no high quality evidence to support any particular intervention for MTSS. This study aims to investigate the effect of shockwave therapy for MTSS. A randomized, sham-controlled, pilot trial in a university-based health clinic including 28 active adults with MTSS. Intervention included standard dose shockwave therapy for the experimental group versus sham dose for the control group, delivered during Week 1-3, 5 and 9. Main outcome measures were pain measured during bone and muscle pressure as well as during running using a numerical rating scale (0-10) and running was measured as pain-limited distance (m), at Week 1 (baseline) and Week 10 (post-intervention). Self-perception of change was measured using the Global Rating of Change Scale (-7 to +7) at Week 10 (post-intervention). Pain (palpation) was reduced in the experimental group by 1.1 out of 10.0 (95% CI -2.3 to 0.0) less than the control group. There were no other statistically significant differences between the groups. Standard dose shockwave therapy is not more effective than sham dose at improving pain or running distance in MTSS. However, the sham dose may have had a clinical effect. Further investigation including a no intervention control is warranted to evaluate the effect of shockwave therapy in the management of MTSS. Copyright © 2016 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

76 FR 5237 - Surface Transportation Project Delivery Pilot Program; Caltrans Audit Report

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-28

...] Surface Transportation Project Delivery Pilot Program; Caltrans Audit Report AGENCY: Federal Highway... participating in the Pilot Program, 23 U.S.C. 327(g) mandates semiannual audits during each of the first 2 years of State participation. This final report presents the findings from the fifth FHWA audit of the...

AN ASSESSMENT OF RESEARCH RELEVANT TO PILOT TRAINING.

ERIC Educational Resources Information Center

SMODE, ALFRED F.; AND OTHERS

THIS REPORT PRESENTS A CRITICAL REVIEW AND INTERPRETATION OF THE CONSIDERABLE AMOUNT OF RESEARCH DATA THAT HAVE EITHER DIRECT OR INDIRECT IMPLICATIONS FOR THE TRAINING OF PILOTS. THE PURPOSE IS TO ORGANIZE SYSTEMATICALLY THE RESEARCH FINDINGS FROM THE HUMAN PERFORMANCE AND THE TRAINING RESEARCH LITERATURE THAT ARE PERTINENT TO PILOT TRAINING AND,…

77 FR 26355 - Surface Transportation Project Delivery Pilot Program; Caltrans Audit Report

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-03

...] Surface Transportation Project Delivery Pilot Program; Caltrans Audit Report AGENCY: Federal Highway... participating in the Pilot Program, 23 U.S.C. 327(g) mandates semiannual audits during each of the first 2 years of State participation. This final report presents the findings from the sixth FHWA audit of the...

Strong Results, High Demand: A Four-Year Study of Boston's Pilot High Schools

ERIC Educational Resources Information Center

Tung, Rosann; Ouimette, Monique

2007-01-01

New research from the Center for Collaborative Education finds that students in Boston's Pilot high schools outperform students from other non-exam Boston Public Schools on every standard measure of engagement and performance. This level of achievement holds for every racial, economic, and academic subgroup examined. Pilot high school students…

Pilots using selective serotonin reuptake inhibitors compared to other fatally injured pilots.

PubMed

Rogers, Paul; Hileman, Christy; Salazar, Guillermo; Cliburn, Kacey; Paskoff, Lawrence; Hathaway, William; Gildea, Kevin; Tejera Villalaz, Victor Hugo

2017-10-01

Selective Serotonin Reuptake Inhibitors (SSRI) were a disqualifying medication for U.S. civil pilots before April 5, 2010. After this date, a Federal Aviation Administration policy was created that allowed airmen, on select SSRIs, a pathway to hold a valid medical certificate. The purpose of this study was to provide a detailed look at SSRIs in the U.S. pilot population since the inception of this new policy. We examined the toxicology results from fatally injured airmen in addition to outcomes concerning pilots who are participating in the program. This study examined data from the Civil Aerospace Medical Institute's Bioaeronautical Sciences Research Laboratory in conjunction with the Medical Analysis Tracking Registry and the Document Imaging and Workflow System. A count-based regression model quantified the relationships between positive SSRI findings with additional factors of interest. These factors included pilot rating, ethanol, and first generation antihistamines. There were 1484 fatally injured airmen over the six year study period, of which 44-tested positive for an SSRI. First-generation antihistamines were statistically associated with positive findings of SSRIs. Published by Elsevier Ltd.

The effects of a designer music intervention on patients' anxiety, pain, and experience of colonoscopy: a short report on a pilot study.

PubMed

Martindale, Fiona; Mikocka-Walus, Antonina A; Walus, Bartlomiej P; Keage, Hannah; Andrews, Jane M

2014-01-01

There is a controversy on whether listening to music before or during colonoscopy reduces anxiety and pain and improves satisfaction and compliance with the procedure. This study aimed to establish whether specifically designed music significantly affects anxiety, pain, and experience associated with colonoscopy. In this semirandomized controlled study, 34 patients undergoing a colonoscopy were provided with either muted headphones (n = 17) or headphones playing the investigator-selected music (n = 17) for 10 minutes before and during colonoscopy. Anxiety, pain, sedation dose, and overall experience were measured using quantitative measures and scales. Participants' state anxiety decreased over time (P < .001). However, music did not significantly reduce anxiety (P = .441), pain scores (P = .313), or midazolam (P = .327) or fentanyl doses (P = .295). Despite these findings, 100% of the music group indicated that they would want music if they were to repeat the procedure, as compared with only 50% of those in the nonmusic group wanting to wear muted headphones. Although no significant effects of music on pain, anxiety, and sedation were found, a clear preference for music was expressed, therefore warranting further research on this subject.

Prospective pilot trial of PerMIT versus standard anticoagulation service management of patients initiating oral anticoagulation.

PubMed

Borgman, Mark P; Pendleton, Robert C; McMillin, Gwendolyn A; Reynolds, Kristen K; Vazquez, Sara; Freeman, Andrew; Wilson, Andrew; Valdes, Roland; Linder, Mark W

2012-09-01

We performed a randomised pilot trial of PerMIT, a novel decision support tool for genotype-based warfarin initiation and maintenance dosing, to assess its efficacy for improving warfarin management. We prospectively studied 26 subjects to compare PerMIT-guided management with routine anticoagulation service management. CYP2C9 and VKORC1 genotype results for 13 subjects randomly assigned to the PerMIT arm were recorded within 24 hours of enrolment. To aid in INR interpretation, PerMIT calculates estimated loading and maintenance doses based on a patient's genetic and clinical characteristics and displays calculated S-warfarin plasma concentrations based on planned or administered dosages. In comparison to control subjects, patients in the PerMIT study arm demonstrated a 3.6-day decrease in the time to reach a stabilised INR within the target therapeutic range (4.7 vs. 8.3 days, p = 0.015); a 12.8% increase in time spent within the therapeutic interval over the first 25 days of therapy (64.3% vs. 55.3%, p = 0.180); and a 32.9% decrease in the frequency of warfarin dose adjustments per INR measurement (38.3% vs. 57.1%, p = 0.007). Serial measurements of plasma S-warfarin concentrations were also obtained to prospectively evaluate the accuracy of the pharmacokinetic model during induction therapy. The PerMIT S-warfarin plasma concentration model estimated 62.8% of concentrations within 0.15 mg/l. These pilot data suggest that the PerMIT method and its incorporation of genotype/phenotype information may help practitioners increase the safety, efficacy, and efficiency of warfarin therapeutic management.

Development of a manualized protocol of massage therapy for clinical trials in osteoarthritis.

PubMed

Ali, Ather; Kahn, Janet; Rosenberger, Lisa; Perlman, Adam I

2012-10-04

Clinical trial design of manual therapies may be especially challenging as techniques are often individualized and practitioner-dependent. This paper describes our methods in creating a standardized Swedish massage protocol tailored to subjects with osteoarthritis of the knee while respectful of the individualized nature of massage therapy, as well as implementation of this protocol in two randomized clinical trials. The manualization process involved a collaborative process between methodologic and clinical experts, with the explicit goals of creating a reproducible semi-structured protocol for massage therapy, while allowing some latitude for therapists' clinical judgment and maintaining consistency with a prior pilot study. The manualized protocol addressed identical specified body regions with distinct 30- and 60-min protocols, using standard Swedish strokes. Each protocol specifies the time allocated to each body region. The manualized 30- and 60-min protocols were implemented in a dual-site 24-week randomized dose-finding trial in patients with osteoarthritis of the knee, and is currently being implemented in a three-site 52-week efficacy trial of manualized Swedish massage therapy. In the dose-finding study, therapists adhered to the protocols and significant treatment effects were demonstrated. The massage protocol was manualized, using standard techniques, and made flexible for individual practitioner and subject needs. The protocol has been applied in two randomized clinical trials. This manualized Swedish massage protocol has real-world utility and can be readily utilized both in the research and clinical settings. Clinicaltrials.gov NCT00970008 (18 August 2009).

Supporting Police Community Support Officers to Become Effective School Link Officers: Key Stakeholder Perceptions of a Pilot Professional Development Programme

ERIC Educational Resources Information Center

Thomas, Lorraine; Trotman, Dave

2017-01-01

This article presents the findings of a pilot professional development programme designed to support police community support officers (PCSOs) to become effective school link officers (SLOs) within urban secondary schools in the English West Midlands. Findings are presented via perceptions of key stakeholders: SLOs themselves; school-based mentors…

CCSS Literacy and Math Tools: An Interim Report on Implementation and Sustainability during the Pilot Year

ERIC Educational Resources Information Center

Reumann-Moore, Rebecca; Lawrence, Nancy; Sanders, Felicia; Shaw, Kate; Christman, Jolley Bruce

2011-01-01

This document summarizes the findings from the initial round of research on the development and piloting of two types of instructional tools designed to support teachers' integration of the Common Core State Standards (CCSS) in literacy and math. In this interim report, Research for Action (RFA) presents key findings from the first half of the…

Assessing I-Grid(TM) web-based monitoring for power quality and reliability benchmarking

DOE Office of Scientific and Technical Information (OSTI.GOV)

Divan, Deepak; Brumsickle, William; Eto, Joseph

2003-04-30

This paper presents preliminary findings from DOEs pilot program. The results show how a web-based monitoring system can form the basis for aggregation of data and correlation and benchmarking across broad geographical lines. A longer report describes additional findings from the pilot, including impacts of power quality and reliability on customers operations [Divan, Brumsickle, Eto 2003].

SU-E-T-197: Helical Cranial-Spinal Treatments with a Linear Accelerator

DOE Office of Scientific and Technical Information (OSTI.GOV)

Anderson, J; Bernard, D; Liao, Y

2014-06-01

Purpose: Craniospinal irradiation (CSI) of systemic disease requires a high level of beam intensity modulation to reduce dose to bone marrow and other critical structures. Current helical delivery machines can take 30 minutes or more of beam-on time to complete these treatments. This pilot study aims to test the feasibility of performing helical treatments with a conventional linear accelerator using longitudinal couch travel during multiple gantry revolutions. Methods: The VMAT optimization package of the Eclipse 10.0 treatment planning system was used to optimize pseudo-helical CSI plans of 5 clinical patient scans. Each gantry revolution was divided into three 120° arcsmore » with each isocenter shifted longitudinally. Treatments requiring more than the maximum 10 arcs used multiple plans with each plan after the first being optimized including the dose of the others (Figure 1). The beam pitch was varied between 0.2 and 0.9 (couch speed 5- 20cm/revolution and field width of 22cm) and dose-volume histograms of critical organs were compared to tomotherapy plans. Results: Viable pseudo-helical plans were achieved using Eclipse. Decreasing the pitch from 0.9 to 0.2 lowered the maximum lens dose by 40%, the mean bone marrow dose by 2.1% and the maximum esophagus dose by 17.5%. (Figure 2). Linac-based helical plans showed dose results comparable to tomotherapy delivery for both target coverage and critical organ sparing, with the D50 of bone marrow and esophagus respectively 12% and 31% lower in the helical linear accelerator plan (Figure 3). Total mean beam-on time for the linear accelerator plan was 8.3 minutes, 54% faster than the tomotherapy average for the same plans. Conclusions: This pilot study has demonstrated the feasibility of planning pseudo-helical treatments for CSI targets using a conventional linac and dynamic couch movement, and supports the ongoing development of true helical optimization and delivery.« less

AN EXPERIMENTAL ASSESSMENT OF A GROUND PILOT TRAINER IN GENERAL AVIATION.

ERIC Educational Resources Information Center

CHAPMAN, G. COURTNEY

THREE GROUPS OF SUBJECTS WERE TRAINED TO PRIVATE PILOT PROFICIENCY, USING A GROUND PILOT TRAINER, TO FIND HOW MANY HOURS OF GROUND TRAINING CAN BE SUBSTITUTED FOR AIRCRAFT DUAL INSTRUCTION. TRAINING TIME REQUIRED WAS COMPARED BETWEEN GROUPS AND WITH THAT OF A CONTROL GROUP NOT USING A TRAINER. THE GROUP THAT USED THE TRAINER MOST NEEDED…

[Effect of alcohol intake on the ability to pilot aircraft].

PubMed

Ushakov, I B; Egorov, S V

1996-01-01

During the initial 4 hours after alcohol intake at a dose of 1.9 g/kg aircraft operators displayed disturbances in the psychic processes and functions responsible for each (from information reception and processing up to decision-making and building-up the controlling actions) structural elements in their activity resulting in considerable limitation or a complete failure to pilot aircraft. Main disorders included inability to correctly analyse flight situation and loss of skills to automatically control simulator, a sudden depletion of psychophysiological reserves and deterioration of operator's reliability. Less elaborated professional skills appear to be the most vulnerable.

A pilot scale comparison of advanced oxidation processes for estrogenic hormone removal from municipal wastewater effluent.

PubMed

Pešoutová, Radka; Stříteský, Luboš; Hlavínek, Petr

2014-01-01

This study investigates the oxidation of selected endocrine disrupting compounds (estrone, 17β-estradiol, estriol and 17α-ethinylestradiol) during ozonation and advanced oxidation of biologically treated municipal wastewater effluents in a pilot scale. Selected estrogenic substances were spiked in the treated wastewater at levels ranging from 1.65 to 3.59 μg · L(-1). All estrogens were removed by ozonation by more than 99% at ozone doses ≥1.8 mg · L(-1). At a dose of 4.4 · mg L(-1) ozonation reduced concentrations of estrone, 17β-estradiol, estriol and 17α-ethinylestradiol by 99.8, 99.7, 99.9 and 99.7%, respectively. All tested advanced oxidation processes (AOPs) achieved high removal rates but they were slightly lower compared to ozonation. The lower removal rates for all tested advanced oxidation processes are caused by the presence of naturally occurring hydroxyl radical scavengers - carbonates and bicarbonates.

ENabling Reduction of Low-grade Inflammation in SEniors Pilot Study: Concept, Rationale, and Design.

PubMed

Manini, Todd M; Anton, Stephen D; Beavers, Daniel P; Cauley, Jane A; Espeland, Mark A; Fielding, Roger A; Kritchevsky, Stephen B; Leeuwenburgh, Christiaan; Lewis, Kristina H; Liu, Christine; McDermott, Mary M; Miller, Michael E; Tracy, Russell P; Walston, Jeremy D; Radziszewska, Barbara; Lu, Jane; Stowe, Cindy; Wu, Samuel; Newman, Anne B; Ambrosius, Walter T; Pahor, Marco

2017-09-01

To test two interventions to reduce interleukin (IL)-6 levels, an indicator of low-grade chronic inflammation and an independent risk factor for impaired mobility and slow walking speed in older adults. The ENabling Reduction of low-Grade Inflammation in SEniors (ENRGISE) Pilot Study was a multicenter, double-blind, placebo-controlled randomized pilot trial of two interventions to reduce IL-6 levels. Five university-based research centers. Target enrollment was 300 men and women aged 70 and older with an average plasma IL-6 level between 2.5 and 30 pg/mL measured twice at least 1 week apart. Participants had low to moderate physical function, defined as self-reported difficulty walking one-quarter of a mile or climbing a flight of stairs and usual walk speed of less than 1 m/s on a 4-m usual-pace walk. Participants were randomized to losartan, omega-3 fish oil (ω-3), combined losartan and ω-3, or placebo. Randomization was stratified depending on eligibility for each group. A titration schedule was implemented to reach a dose that was safe and effective for IL-6 reduction. Maximal doses were 100 mg/d for losartan and 2.8 g/d for ω-3. IL-6, walking speed over 400 m, physical function (Short Physical Performance Battery), other inflammatory markers, safety, tolerability, frailty domains, and maximal leg strength were measured. Results from the ENRGISE Pilot Study will provide recruitment yields, feasibility, medication tolerance and adherence, and preliminary data to help justify a sample size for a more definitive randomized trial. The ENRGISE Pilot Study will inform a larger subsequent trial that is expected to have important clinical and public health implications for the growing population of older adults with low-grade chronic inflammation and mobility limitations. © 2017, Copyright the Authors Journal compilation © 2017, The American Geriatrics Society.

Milrinone Pharmacokinetics and Pharmacodynamics in Neonates with Persistent Pulmonary Hypertension of the Newborn.

PubMed

Giaccone, Annie; Zuppa, Athena F; Sood, Beena; Cohen, Meryl S; O'Byrne, Michael L; Moorthy, Ganesh; Mathur, Amit; Kirpalani, Haresh

2017-07-01

Objective  To describe the pharmacokinetics and pharmacodynamics of milrinone in infants with persistent pulmonary hypertension of the newborn (PPHN) and to explore the impact of age on milrinone disposition. Design  Randomized, open label pilot study. Setting  Multicenter; level 3 and level 4 neonatal intensive care units. Patients  Six infants ≥34 weeks' gestational age and < 10 days of life with persistent hypoxemia receiving inhaled nitric oxide. Intervention  Intravenous milrinone lactate in one of two dosing regimens: (1) low dose, 20 mcg/kg bolus followed by 0.2 mcg/kg/minute, and (2) standard dose, 50 mcg/kg bolus followed by 0.5 mcg/kg/minute. Measurements and Main Results  The final structural model was a two-compartment disposition model with interindividual variability estimated on clearance (CL). The estimated value of CL is 7.65 mL/minute/3.4 kg (3.05 mL/minute/kg). The addition of age improved the precision of the CL estimate, and CL increased with chronological age in days. The oxygenation index was highly variable within each participant and improved with time. There were no observed safety concerns in either dosing group. Conclusion  The CL of milrinone in newborns with PPHN is reduced and increases with age. In this pilot study, we did not see significant pharmacodynamic or safety effects associated with drug exposure. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Single-dose safety and pharmacokinetic evaluation of fluorocoxib A: pilot study of novel cyclooxygenase-2-targeted optical imaging agent in a canine model

NASA Astrophysics Data System (ADS)

Cekanova, Maria; Uddin, Md. Jashim; Legendre, Alfred M.; Galyon, Gina; Bartges, Joseph W.; Callens, Amanda; Martin-Jimenez, Tomas; Marnett, Lawrence J.

2012-11-01

We evaluated preclinical single-dose safety, pharmacokinetic properties, and specific uptake of the new optical imaging agent fluorocoxib A in dogs. Fluorocoxib A, N-[(5-carboxy-X-rhodaminyl)but-4-yl]-2-[1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indol-3-yl]acetamide, selectively binds and inhibits the cyclooxygenase-2 (COX-2) enzyme, which is overexpressed in many cancers. Safety pilot studies were performed in research dogs following intravenous (i.v.) administration of 0.1 and 1 mg/kg fluorocoxib A. Blood and urine samples collected three days after administration of each dose of fluorocoxib A revealed no evidence of toxicity, and no clinically relevant adverse events were noted on physical examination of exposed dogs over that time period. Pharmacokinetic parameters were assessed in additional research dogs from plasma collected at several time points after i.v. administration of fluorocoxib A using high-performance liquid chromatography analysis. The pharmacokinetic studies using 1 mg/kg showed a peak of fluorocoxib A (92±28 ng/ml) in plasma collected at 0.5 h. Tumor specific uptake of fluorocoxib A was demonstrated using a dog diagnosed with colorectal cancer expressing COX-2. Our data support the safe single-dose administration and in vivo efficacy of fluorocoxib A, suggesting a high potential for successful translation to clinical use as an imaging agent for improved tumor detection in humans.

Technology and Learning at Home: Findings from the Evaluation of the Home Access Programme Pilot

ERIC Educational Resources Information Center

Jewitt, C.; Parashar, U.

2011-01-01

This paper examines the impact of a UK government initiative, introduced in late 2008 and closed in 2011, to provide a computer and 1 year of Internet connectivity to low-income households with children aged 5-19 years. This paper presents and discusses the findings from the evaluation of the initiative, the Home Access Programme (HAP) pilot study…

A new dose of maximal-intensity interval training in hypoxia to improve body composition and hemoglobin and hematocrit levels: a pilot study.

PubMed

Camacho-Cardenosa, Marta; Camacho-Cardenosa, Alba; Martínez Guardado, Ismael; Marcos-Serrano, Marta; Timon, Rafael; Olcina, Guillermo

2017-01-01

This pilot study had the aim to determine the effects of a new dose of maximal-intensity interval training in hypoxia in active adults. Twenty-four university student volunteers were randomly assigned to three groups: hypoxia group, normoxia group or control group. The eight training sessions consisted of 2 sets of 5 repeated sprints of 10 seconds with a recovery of 20 seconds between sprints and a recovery period of 10 minutes between sets. Body composition was measured following standard procedures. A blood sample was taken for an immediate hematocrit (HCT) and hemoglobin (Hb) concentration assessment. An all-out 3-ute test was performed to evaluate ventilation parameters and power. HCT and Hb were significantly higher for the hypoxia group in Post- and Det- (P=0.01; P=0.03). Fat mass percentage was significantly lower for the hypoxia group in both assessments (P=0.05; P=0.05). The hypoxia group underwent a significant increase in mean power after the recovery period. A new dose of 8 sessions of maximal-intensity interval training in hypoxia is enough to decrease the percentage of fat mass and to improve HCT and Hb parameters and mean muscle power in healthy and active adults.

Pre-Service Teacher Training in Malawi: Findings of a Pilot Study on the Viability of Media Players for Teacher Development

ERIC Educational Resources Information Center

Carrier, Carol; Finholt-Daniel, Matt; Sales, Gregory C.

2012-01-01

As part of the United States Agency for International Development (USAID) funded Malawi Teacher Professional Development Support project, a sub-task was the piloting of an alternative technology that could be used for improving the quality and consistency of teacher continued professional development (CPD). The pilot, which included 26 open and…

The Internet and Some International Regulatory Issues Relating to Content: A Pilot Comparative Study.

ERIC Educational Resources Information Center

Australian Broadcasting Authority.

In December 1996 UNESCO commissioned the Australian Broadcasting Authority to conduct a pilot study which considered a range of online issues; this report outlines the findings of the pilot study, based on data collected between February and May 1997 and updated in July 1997. The objective is to identify the main types of Internet content which…

A Randomized, Placebo-Controlled Pilot Study of Quetiapine-XR Monotherapy or Adjunctive Therapy to Antidepressant in Acute Major Depressive Disorder with Current Generalized Anxiety Disorder.

PubMed

Li, Ranran; Wu, Renrong; Chen, Jun; Kemp, David E; Ren, Ming; Conroy, Carla; Chan, Philip; Serrano, Mary Beth; Ganocy, Stephen J; Calabrese, Joseph R; Gao, Keming

2016-03-01

To pilot efficacy and safety data of quetiapine-XR monotherapy or adjunctive therapy to antidepressant(s) in the acute treatment of MDD with current generalized anxiety disorder (GAD). The Mini International Neuropsychiatric Interview was used to ascertain the diagnosis of DSM-IV Axis I disorders. Eligible patients were randomly assigned to quetiapine-XR or placebo for up to 8 weeks. Changes from baseline to endpoint in Hamilton Depression Rating Scale-17 items (HAMD-17), Hamilton Anxiety Rating Scale (HAM-A), Clinical Global Impression-Severity (CGI-S), Quick Inventory of Depression Symptomatology-16 items Self-Report (QIDS-16-SR) total scores, and other outcome measures were analyzed with the last observation carried forward strategy and/or mixed-effects modeling for repeated measures. Of the 34 patients screened, 23 patients were randomized to receive quetiapine-XR (n = 11) or placebo (n = 12), with 5 and 4 completing the study, respectively. The mean dose of quetiapine-XR was 154 ± 91 mg/d. The change from baseline to endpoint in the total scores of HAMD-17, HAM-A, QIDS-16-SR, and CGI-S were significant in the quetiapine-XR group, but only the change in HAM-A total score was significant in the placebo group. The differences in these changes between the two groups were only significant in CGI-S scores, with the rest of numerical larger in the quetiapine-XR group. The most common side effects from quetiapine-XR were dry mouth, somnolence/sedation, and fatigue. In this pilot study, quetiapine-XR was numerically superior to placebo in reducing depressive and anxiety symptoms in patients with MDD and current GAD. Large sample studies are warranted to support or refute these preliminary findings.

Toxicological findings in 889 fatally injured obese pilots involved in aviation accidents.

PubMed

Chaturvedi, Arvind K; Botch, Sabra R; Ricaurte, Eduard M

2012-03-01

Prevalence of drugs in fatally injured obese pilots involved in aviation accidents has not been evaluated. Therefore, toxicological findings in such pilots (body mass index ≥30 kg/m(2) ) were examined in a data set derived from the Civil Aerospace Medical Institute's (CAMI's) Scientific Information System for 1990-2005. Aeromedical histories of these aviators were retrieved from the CAMI medical certification and toxicology databases, and the cause/factors in the related accidents from the National Transportation Safety Board's database. In 311 of the 889 pilots, carbon monoxide, cyanide, ethanol, and drugs were found, and glucose and hemoglobin A(1c) were elevated. Of the 889 pilots, 107 had an obesity-related medical history. The health and/or medical condition(s) of, and/or the use of ethanol and/or drugs by, pilots were the cause/factors in 55 (18%) of the 311 accidents. Drugs found were primarily for treating obesity-related medical conditions such as depression, hypertension, and coronary heart disease. 2011 American Academy of Forensic Sciences. Published 2011. This article is a U.S. Government work and is in the public domain in the U.S.A.

Pilot Biofeedback Training in the Cognitive Awareness Training Study (CATS)

NASA Technical Reports Server (NTRS)

Uenking, M.

2000-01-01

One of the ongoing problems that pilots face today is a diminished state of awareness such as boredom, sleepiness, or fatigue during cruise conditions that could result in various pilot errors. This study utilized a cognitive training exercise to sharpen the pilot's awareness during simulated flight thereby providing them with a means to overcome these diminished states of awareness. This study utilizes psychophysiological methods in an attempt to assess a pilot's state of awareness more directly. In turn, the pilots will be able to train themselves to recognize these states of awareness and be more mentally sharp during mundane tasks such as those experienced in cruise conditions. The use of these measurement tools may be beneficial for researchers working within the NASA Aviation Safety Program. This paper will provide the reader with some background information concerning the motivation for the study, a brief description of the experimental setup and design matrix, the dependent and independent variables that were employed, and some preliminary findings based on some of the subjective and objective data that was collected. These preliminary findings are of part of an ongoing study being conducted at the NASA Langley Research Center in Hampton, Virginia.

Quiet Pavement Pilot Program : Progress Report 3

DOT National Transportation Integrated Search

2012-09-01

Since 2003, the Arizona Department of Transportation (ADOT) has been conducting a Quiet Pavement : Pilot Program (QPPP) in cooperation with the Federal Highway Administration (FHWA). This report : presents the noise findings of this research through ...

A live-attenuated and an inactivated chimeric porcine circovirus (PCV)1-2 vaccine are both effective at inducing a humoral immune response and reducing PCV2 viremia and intrauterine infection in female swine of breeding age.

PubMed

Hemann, Michelle; Beach, Nathan M; Meng, Xiang-Jin; Wang, Chong; Halbur, Patrick G; Opriessnig, Tanja

2014-01-01

The objective of this pilot study was to determine the efficacy of inactivated (1 or 2 dose) and live-attenuated chimeric porcine circovirus (PCV)1-2 vaccines in sows using the PCV2-spiked semen model. Thirty-five sows were randomly divided into 6 groups: negative and positive controls, 1 dose inactivated PCV1-2 vaccine challenged (1-VAC-PCV2), 2 dose inactivated PCV1-2 vaccine challenged (2-VAC-PCV2), 1 dose live-attenuated PCV1-2 vaccine unchallenged (1-LIVE-VAC), and 1 dose live-attenuated PCV1-2 vaccine challenged (1-LIVE-VAC-PCV2). The inactivated PCV1-2 vaccine induced higher levels of PCV2-specific antibodies in dams. All vaccination strategies provided good protection against PCV2 viremia in dams, whereas the majority of the unvaccinated sows were viremic. Four of the 35 dams became pregnant: a negative control, a positive control, a 2-VAC-PCV2 sow, and a 1-LIVE-VAC-PCV2 sow. The PCV2 DNA was detected in 100%, 67%, and 29% of the fetuses obtained from the positive control, inactivated vaccinated, or live-attenuated vaccinated dams, respectively. The PCV2 antigen in hearts was only detectable in the positive control litter (23% of the fetuses). The PCV1-2 DNA was detected in 29% of the fetuses in the litter from the 1-LIVE-VAC-PCV2 dam. Under the conditions of this pilot study, both vaccines protected against PCV2 viremia in breeding age animals; however, vertical transmission was not prevented.

A live-attenuated and an inactivated chimeric porcine circovirus (PCV)1-2 vaccine are both effective at inducing a humoral immune response and reducing PCV2 viremia and intrauterine infection in female swine of breeding age

PubMed Central

Hemann, Michelle; Beach, Nathan M.; Meng, Xiang-Jin; Wang, Chong; Halbur, Patrick G.; Opriessnig, Tanja

2014-01-01

The objective of this pilot study was to determine the efficacy of inactivated (1 or 2 dose) and live-attenuated chimeric porcine circovirus (PCV)1-2 vaccines in sows using the PCV2-spiked semen model. Thirty-five sows were randomly divided into 6 groups: negative and positive controls, 1 dose inactivated PCV1-2 vaccine challenged (1-VAC-PCV2), 2 dose inactivated PCV1-2 vaccine challenged (2-VAC-PCV2), 1 dose live-attenuated PCV1-2 vaccine unchallenged (1-LIVE-VAC), and 1 dose live-attenuated PCV1-2 vaccine challenged (1-LIVE-VAC-PCV2). The inactivated PCV1-2 vaccine induced higher levels of PCV2-specific antibodies in dams. All vaccination strategies provided good protection against PCV2 viremia in dams, whereas the majority of the unvaccinated sows were viremic. Four of the 35 dams became pregnant: a negative control, a positive control, a 2-VAC-PCV2 sow, and a 1-LIVE-VAC-PCV2 sow. The PCV2 DNA was detected in 100%, 67%, and 29% of the fetuses obtained from the positive control, inactivated vaccinated, or live-attenuated vaccinated dams, respectively. The PCV2 antigen in hearts was only detectable in the positive control litter (23% of the fetuses). The PCV1-2 DNA was detected in 29% of the fetuses in the litter from the 1-LIVE-VAC-PCV2 dam. Under the conditions of this pilot study, both vaccines protected against PCV2 viremia in breeding age animals; however, vertical transmission was not prevented. PMID:24396175

Flight deck disturbance management: a simulator study of diagnosis and recovery from breakdowns in pilot-automation coordination.

PubMed

Nikolic, Mark I; Sarter, Nadine B

2007-08-01

To examine operator strategies for diagnosing and recovering from errors and disturbances as well as the impact of automation design and time pressure on these processes. Considerable efforts have been directed at error prevention through training and design. However, because errors cannot be eliminated completely, their detection, diagnosis, and recovery must also be supported. Research has focused almost exclusively on error detection. Little is known about error diagnosis and recovery, especially in the context of event-driven tasks and domains. With a confederate pilot, 12 airline pilots flew a 1-hr simulator scenario that involved three challenging automation-related tasks and events that were likely to produce erroneous actions or assessments. Behavioral data were compared with a canonical path to examine pilots' error and disturbance management strategies. Debriefings were conducted to probe pilots' system knowledge. Pilots seldom followed the canonical path to cope with the scenario events. Detection of a disturbance was often delayed. Diagnostic episodes were rare because of pilots' knowledge gaps and time criticality. In many cases, generic inefficient recovery strategies were observed, and pilots relied on high levels of automation to manage the consequences of an error. Our findings describe and explain the nature and shortcomings of pilots' error management activities. They highlight the need for improved automation training and design to achieve more timely detection, accurate explanation, and effective recovery from errors and disturbances. Our findings can inform the design of tools and techniques that support disturbance management in various complex, event-driven environments.

Removal of Emerging Contaminants and Estrogenic Activity from Wastewater Treatment Plant Effluent with UV/Chlorine and UV/H2O2 Advanced Oxidation Treatment at Pilot Scale

PubMed Central

Kuch, Bertram; Lange, Claudia; Richter, Philipp; Kugele, Amélie; Minke, Ralf

2018-01-01

Effluent of a municipal wastewater treatment plant (WWTP) was treated on-site with the UV/chlorine (UV/HOCl) advanced oxidation process (AOP) using a pilot plant equipped with a medium pressure UV lamp with an adjustable performance of up to 1 kW. Results obtained from parallel experiments with the same pilot plant, where the state of the art UV/H2O2 AOP was applied, were compared regarding the removal of emerging contaminants (EC) and the formation of adsorbable organohalogens (AOX). Furthermore, the total estrogenic activity was measured in samples treated with the UV/chlorine AOP. At an energy consumption of 0.4 kWh/m3 (0.4 kW, 1 m3/h) and in a range of oxidant concentrations from 1 to 6 mg/L, the UV/chlorine AOP had a significantly higher EC removal yield than the UV/H2O2 AOP. With free available chlorine concentrations (FAC) in the UV chamber influent of at least 5 mg/L (11 mg/L of dosed Cl2), the total estrogenic activity could be reduced by at least 97%. To achieve a certain concentration of FAC in the UV chamber influent, double to triple the amount of dosed Cl2 was needed, resulting in AOX concentrations of up to 520 µg/L. PMID:29735959

Aerobic and Cognitive Exercise (ACE) Pilot Study for Older Adults: Executive Function Improves with Cognitive Challenge While Exergaming.

PubMed

Barcelos, Nicole; Shah, Nikita; Cohen, Katherine; Hogan, Michael J; Mulkerrin, Eamon; Arciero, Paul J; Cohen, Brian D; Kramer, Arthur F; Anderson-Hanley, Cay

2015-11-01

Dementia cases are increasing worldwide; thus, investigators seek to identify interventions that might prevent or ameliorate cognitive decline in later life. Extensive research confirms the benefits of physical exercise for brain health, yet only a fraction of older adults exercise regularly. Interactive mental and physical exercise, as in aerobic exergaming, not only motivates, but has also been found to yield cognitive benefit above and beyond traditional exercise. This pilot study sought to investigate whether greater cognitive challenge while exergaming would yield differential outcomes in executive function and generalize to everyday functioning. Sixty-four community based older adults (mean age=82) were randomly assigned to pedal a stationary bike, while interactively engaging on-screen with: (1) a low cognitive demand task (bike tour), or (2) a high cognitive demand task (video game). Executive function (indices from Trails, Stroop and Digit Span) was assessed before and after a single-bout and 3-month exercise intervention. Significant group × time interactions were found after a single-bout (Color Trails) and after 3 months of exergaming (Stroop; among 20 adherents). Those in the high cognitive demand group performed better than those in the low cognitive dose condition. Everyday function improved across both exercise conditions. Pilot data indicate that for older adults, cognitive benefit while exergaming increased concomitantly with higher doses of interactive mental challenge.

Removal of Emerging Contaminants and Estrogenic Activity from Wastewater Treatment Plant Effluent with UV/Chlorine and UV/H₂O₂ Advanced Oxidation Treatment at Pilot Scale.

PubMed

Rott, Eduard; Kuch, Bertram; Lange, Claudia; Richter, Philipp; Kugele, Amélie; Minke, Ralf

2018-05-07

Effluent of a municipal wastewater treatment plant (WWTP) was treated on-site with the UV/chlorine (UV/HOCl) advanced oxidation process (AOP) using a pilot plant equipped with a medium pressure UV lamp with an adjustable performance of up to 1 kW. Results obtained from parallel experiments with the same pilot plant, where the state of the art UV/H₂O₂ AOP was applied, were compared regarding the removal of emerging contaminants (EC) and the formation of adsorbable organohalogens (AOX). Furthermore, the total estrogenic activity was measured in samples treated with the UV/chlorine AOP. At an energy consumption of 0.4 kWh/m³ (0.4 kW, 1 m³/h) and in a range of oxidant concentrations from 1 to 6 mg/L, the UV/chlorine AOP had a significantly higher EC removal yield than the UV/H₂O₂ AOP. With free available chlorine concentrations (FAC) in the UV chamber influent of at least 5 mg/L (11 mg/L of dosed Cl₂), the total estrogenic activity could be reduced by at least 97%. To achieve a certain concentration of FAC in the UV chamber influent, double to triple the amount of dosed Cl₂ was needed, resulting in AOX concentrations of up to 520 µg/L.

A pilot single arm observational study of sofosbuvir/ledipasvir (200 + 45 mg) in 6- to 12- year old children.

PubMed

El-Shabrawi, M H F; Kamal, N M; El-Khayat, H R; Kamal, E M; AbdElgawad, M M A H; Yakoot, M

2018-04-25

No available data on the use of sofosbuvir/ledipasvir combination in treatment of hepatitis C virus (HCV) infection in children 6- to 12- year old. To assess the safety and efficacy of sofosbuvir plus ledipasvir in children 6- to 12- year old with chronic HCV genotype 4 infection. This is a pilot prospective single arm observational open-label multicentre study. A total of 20 consecutive eligible chronic HCV infected children, aged from 6- to 12- years were included in this study and treated with a fixed sofosbuvir/ledipasvir combination in half the adult dose (200/45 mg) once daily for 12 weeks. Laboratory tests including virological markers were measured at baseline, 2, 4, 8 and 12 weeks (end of treatment [EOT]), and 12 weeks after end of treatment for sustained virological response 12 (SVR12). The intention-to-treat (ITT) SVR12 rate was 19/20 (95%; 95% CI: 76.4%-99.1%). SVR12 was not assessed in one patient who was lost to follow-up after showing viral negativity at the EOT12. All the remaining 19 patients (100%, 95% CI: 83.18%-100%) who completed the full protocol and follow-up visits achieved SVR12 with normal liver, haematological, and renal function tests and no side effects or fatalities. This pilot study demonstrated that the fixed dose sofosbuvir/ledipasvir combination could be safe and effective treatment in children 6- to 12- years with chronic hepatitis C genotype 4 infection. Our pilot results might encourage larger and multicentre studies in this age group. © 2018 John Wiley & Sons Ltd.

Pharmaceutic factors affecting pediatric compliance.

PubMed

Mattar, M E; Markello, J; Yaffe, S J

1975-01-01

Evaluation of treatment given at home was studied in children with otitis media who were seen in an outpatient clinic. Full compliance was present in only 5% of the initial 100 patients (Study A). Practical factors limiting their compliance included inadequate dispensing of medication at drug stores, 15%; incorrect therapy schedule, 36%; early termination, 37%; spilled medicine, 7%; therapy shared, 5%. Because of these findings, a plan was implemented (Study B) in which hospital pharmacy personnel gave patient families verbal and written instructions for administering medications that were dispensed, together with a calibrated measuring device and a calendar to record doses taken. Full compliance was raised to 51% in this pilot group (of 33 patients) as compared with 8.5% in 20 concurrent controls who went to neighborhood drug stores. The importance of detailed therapy instructions is stressed. The potential role of the pharmacist in improving compliance is demonstrated.

Brief report: Pilot single-blind placebo lead-in study of acamprosate in youth with autistic disorder.

PubMed

Erickson, Craig A; Wink, Logan K; Early, Maureen C; Stiegelmeyer, Elizabeth; Mathieu-Frasier, Lauren; Patrick, Vanessa; McDougle, Christopher J

2014-04-01

An excitatory/inhibitory (E:I) imbalance marked by enhanced glutamate and deficient gamma-aminobutyric acid (GABA) neurotransmission may contribute to the pathophysiology of autism spectrum disorders (ASD). We report on the first single-blind placebo lead-in trial of acamprosate, a drug with putative mechanisms restoring E:I imbalance, in twelve youth with ASD. We conducted a 12-week single-blind, placebo lead-in study of acamprosate in youth age 5-17 years with autistic disorder. Six of nine subjects who received active drug treatment were deemed treatment responders (defined by a score at final visit of "very much improved" or "much improved" on the Clinical Global Impressions Improvement scale) and ≥25% improvement on the Aberrant Behavior Checklist Social Withdrawal subscale. Future larger-scale dose finding studies of acamprosate in ASD may be warranted given this preliminary indication of benefit.

Dulaglutide (LY-2189265) for the treatment of type 2 diabetes.

PubMed

Scheen, André J

2016-01-01

Dulaglutide is a new once-weekly glucagon-like peptide-1 receptor agonist for the management of hyperglycemia in adult patients with type 2 diabetes. It stimulates dose-dependent insulin secretion and reduces glucagon secretion, both in a glucose-dependent manner. Efficacy on blood glucose control and safety were demonstrated in the large AWARD program in type 2 diabetic patients treated with diet, metformin, dual oral therapy or insulin lispro with or without metformin, confirming findings of pilot studies in Caucasian patients and data in Japanese patients. Dulaglutide 1.5 mg once weekly was superior to metformin, sitagliptin, insulin glargine and exenatide twice daily, and non-inferior to liraglutide 1.8 mg once daily regarding the reduction in glycated hemoglobin. A modest but significant weight loss was consistently observed. Most frequent adverse events were transient and generally mild gastrointestinal disturbances. Clinical outcomes of dulaglutide will not be known until the large prospective cardiovascular outcome trial REWIND is complete.

Deuterium dilution technique for body composition assessment: resolving methodological issues in children with moderate acute malnutrition.

PubMed

Fabiansen, Christian; Yaméogo, Charles W; Devi, Sarita; Friis, Henrik; Kurpad, Anura; Wells, Jonathan C

2017-08-01

Childhood malnutrition is highly prevalent and associated with high mortality risk. In observational and interventional studies among malnourished children, body composition is increasingly recognised as a key outcome. The deuterium dilution technique has generated high-quality data on body composition in studies of infants and young children in several settings, but its feasibility and accuracy in children suffering from moderate acute malnutrition requires further study. Prior to a large nutritional intervention trial among children with moderate acute malnutrition, we conducted pilot work to develop and adapt the deuterium dilution technique. We refined procedures for administration of isotope doses and collection of saliva. Furthermore, we established that equilibration time in local context is 3 h. These findings and the resulting standard operating procedures are important to improve data quality when using the deuterium dilution technique in malnutrition studies in field conditions, and may encourage a wider use of isotope techniques.

Immunogenicity and safety of the candidate RTS,S/AS01 vaccine in young Nigerian children: a randomized, double-blind, lot-to-lot consistency trial.

PubMed

Umeh, Rich; Oguche, Stephen; Oguonu, Tagbo; Pitmang, Simon; Shu, Elvis; Onyia, Jude-Tony; Daniyam, Comfort A; Shwe, David; Ahmad, Abdullahi; Jongert, Erik; Catteau, Grégory; Lievens, Marc; Ofori-Anyinam, Opokua; Leach, Amanda

2014-11-12

For regulatory approval, consistency in manufacturing of vaccine lots is expected to be demonstrated in confirmatory immunogenicity studies using two-sided equivalence trials. This randomized, double-blind study (NCT01323972) assessed consistency of three RTS,S/AS01 malaria vaccine batches formulated from commercial-scale purified antigen bulk lots in terms of anti-CS-responses induced. Healthy children aged 5-17 months were randomized (1:1:1:1) to receive RTS,S/AS01 at 0-1-2 months from one of three commercial-scale purified antigen bulk lots (1600 litres-fermentation scale; commercial-scale lots), or a comparator vaccine batch made from pilot-scale purified antigen bulk lot (20 litres-fermentation scale; pilot-scale lot). The co-primary objectives were to first demonstrate consistency of antibody responses against circumsporozoite (CS) protein at one month post-dose 3 for the three commercial-scale lots and second demonstrate non-inferiority of anti-CS antibody responses at one month post-dose 3 for the commercial-scale lots compared to the pilot-scale lot. Safety and reactogenicity were evaluated as secondary endpoints. One month post-dose-3, anti-CS antibody geometric mean titres (GMT) for the 3 commercial scale lots were 319.6 EU/ml (95% confidence interval (CI): 268.9-379.8), 241.4 EU/ml (207.6-280.7), and 302.3 EU/ml (259.4-352.3). Consistency for the RTS,S/AS01 commercial-scale lots was demonstrated as the two-sided 95% CI of the anti-CS antibody GMT ratio between each pair of lots was within the range of 0.5-2.0. GMT of the pooled commercial-scale lots (285.8 EU/ml (260.7-313.3)) was non-inferior to the pilot-scale lot (271.7 EU/ml (228.5-323.1)). Each RTS,S/AS01 lot had an acceptable tolerability profile, with infrequent reports of grade 3 solicited symptoms. No safety signals were identified and no serious adverse events were considered related to vaccination. RTS,S/AS01 lots formulated from commercial-scale purified antigen bulk batches induced a consistent anti-CS antibody response, and the anti-CS GMT of pooled commercial-scale lots was non-inferior to that of a lot formulated from a pilot-scale antigen bulk batch. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

PAEDIATRIC CT EXPOSURE PRACTICE IN THE COUNTY OF RIO DE JANEIRO: THE NEED TO ESTABLISH DIAGNOSTIC REFERENCE LEVELS.

PubMed

de Jesus, Fillipe M; Magalhães, Luis A G; Kodlulovich, Simone

2016-11-01

A pilot study of dose indicators in paediatric computed tomography (CT) was conducted to prove the need to establish diagnostic reference levels (DRLs) for the county of Rio de Janeiro. The dose descriptors were estimated from the beam dosimetry by applying the protocols used in each examination. The total patient sample included 279 children. Regarding the comparison of the dose-length product values among the hospitals, the high-resolution chest CT scans were distinguished among the three types of examinations, due to the discrepancies of 1148 % (1-5 y age group) and 2248 % (5-10 y age group) presented in Hospital A's dose-length product values relative to Hospital D's dose-length product values. The results showed that without DRL, the dose variation can be significant between hospitals in the same county for the same age group in the same examination. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Nuclear emulsion measurements of the dose contribution from tissue disintegration stars on the apollo-soyuz mission. Technical report No. 2, Jul 76--Mar 77

DOE Office of Scientific and Technical Information (OSTI.GOV)

Schaefer, H.J.

1977-03-15

Analysis of the prong number distribution of a population of disintegration stars in nuclear emulsion allows a quantitative estimate of the fraction of stars originating in the gelatin matrix and thereby an assessment of the tissue-equivalent dose from stars. 996 stars were prong-counted in two 100 micron llford K.2 emulsions from the dosimeter of the Docking Pilot on Apollo-Soyuz and furnished a tissue star dose of 7.8 millirad or 45 millirem. Since star-produced neutrons do not leave visible prongs in emulsion, their dose contribution is not included. Nuclear theory as well as earlier measurements of galactic radiation in the Earth'smore » atmosphere indicate that the dose equivalent from neutrons is about equal to the one from all ionizing secondaries from stars. This would set the total tissue star dose for Apollo-Soyuz at approximately 90 millirem. (Author)« less

Toxicological findings in fatally injured pilots of 979 amateur-built aircraft accidents.

DOT National Transportation Integrated Search

2011-12-01

"Biological samples collected from fatally injured pilots in aviation accidents involving all types of aircraft, including : amateur-built aircraft, are submitted to the Civil Aerospace Medical Institute (CAMI) for accident investigation. : These sam...

Use of applied theatre in health research dissemination and data validation: a pilot study from South Africa

PubMed Central

Stuttaford, Maria; Bryanston, Claudette; Hundt, Gillian Lewando; Connor, Myles; Thorogood, Margaret; Tollman, Steve

2010-01-01

This article reports on a pilot study of the use of applied theatre in the dissemination of health research findings and validation of data. The study took place in South Africa, as part of the Southern Africa Stroke Prevention Initiative (SASPI) and was based at the University/Medical Research Council Rural Public Health and Health Transitions Research Unit (also known as the Agincourt Unit). The aim of SASPI was to investigate the prevalence of stroke and understand the social context of stroke. It was decided to use an applied theatre approach for validating the data and disseminating findings from the anthropological component of the study. The pilot study found that applied theatre worked better in smaller community groups. It allowed data validation and it elicited ideas for future interventions resulting from the health research findings. Evaluation methods of the impact of applied theatre as a vehicle for the dissemination and communication of research findings require further development. PMID:16322042

Hypothesizing that a Pro-Dopaminergic Regulator (KB220z™ Liquid Variant) can Induce “Dopamine Homeostasis” and Provide Adjunctive Detoxification Benefits in Opiate/Opioid Dependence

PubMed Central

Blum, Kenneth; Whitney, Debra; Fried, Lye; Febo, Marcelo; Waite, Roger L; Braverman, Eric R; Dushaj, Kristina; Li, Mona; Giordano, John; Demetrovics, Zsolt; Badgaiyan, Rajendra D

2017-01-01

In order to explore the initiation of detoxification of addictive patients to opiates/opioids (along with some other anti-withdrawal agents), we developed a protocol to be utilized in treatment centers particularly with heavily dependent opiate/opioid subjects. Out of 17 subjects, only three received Buprenorphine/Naloxone (Bup/nx) along with KB220Z. In this pilot, we first used a dose of KB220Z of 2 oz twice daily before meals along with clonidine and benzodiazepines and other anti-nausea and sleep aids including Gabapentin. The dose of KB220Z was maintained for 6 days in five individuals. In a second scenario, we utilized a higher dose of 4 oz every 6 hours, over a 6-day period. The higher dose was employed in another 12 patients. It is noteworthy that only 3 people have relapsed utilizing these two protocols during the first two weeks of the study, allowing for the remaining 82% to be maintained on KB220Z. The patients have been maintained without any additional Bup/nx for a minimum of 120 days and in one subject, 214 days. We are in the process of testing this hypothesis in multiple treatment centers across the United Sates utilizing data from the Clinical opiate Withdrawal Scale (COWS) pre and post KB220Z. We are in the process of testing this hypothesis in multiple treatment centers across the United Sates. While this does not constitute an acceptable controlled experiment, it does provide some preliminary evidence that agrees with an earlier study. Moreover, because of the utilization of standard detoxifying agents in this detoxification protocol, we cannot make any inference to KB220Z’s effects. However, out of 17 subjects, only three required Bup/nx suggesting an interesting finding. If further confirmed in larger studies, the utilization for opiate/opioid detoxification may provide a novel way to eliminate the need for addictive opioids during withdrawal and detoxification. This paradigm shift may translate to a reduction in utilizing powerful and addictive opioids like buprenorphine and methadone (especially in these patients at high genetic risk for addiction) as not only detoxifying agents, but also maintenance drugs. While extensive research is required, this pilot paves the way for future investigations that could assist in the reduction of addictive opiate/opioid use and mortalities amongst both the young and old in America. PMID:29034323

Analysis of errors detected in external beam audit dosimetry program at Mexican radiotherapy centers

NASA Astrophysics Data System (ADS)

Álvarez-Romero, José T.; Tovar-Muñoz, Víctor M.

2012-10-01

Presented and analyzed are the causes of deviation observed in the pilot postal dosimetry audit program to verify the absorbed dose to water Dw in external beams of teletherapy 60Co and/or linear accelerators in Mexican radiotherapy centers, during the years 2007-2011.

The Impact of Suggestive Maneuver Guidance on UAS Pilots Performing the Detect and Avoid Function

NASA Technical Reports Server (NTRS)

Rorie, Conrad; Fern, Lisa; Shively, Jay

2016-01-01

This presentation discusses the results of a recent UAS Integration into the NAS human-in-the-loop simulation. In the study, 16 active UAS pilots flew a UAS through civil airspace and were tasked with maintaining well clear from other aircraft in the area. Pilots performed the task with four different detect and avoid (DAA) traffic displays, each of which varied in the form of guidance it provided to pilots The present findings focus on how the different displays impacted pilots' measured response to scripted conflicts with their aircraft. Measured response is made up of several components, each of which help inform our understanding of the pilots' role in the overall detect and avoid task.

Does selenium supplementation affect thyroid function? Results from a randomized, controlled, double-blinded trial in a Danish population.

PubMed

Winther, Kristian Hillert; Bonnema, Steen Joop; Cold, Frederik; Debrabant, Birgit; Nybo, Mads; Cold, Søren; Hegedüs, Laszlo

2015-06-01

Selenium is present in the active site of proteins important for thyroid hormone synthesis and metabolism. The objective of this study is to investigate the effect of selenium supplementation in different doses on thyroid function, under conditions of suboptimal dietary selenium intake. The Danish PREvention of Cancer by Intervention with SElenium pilot study (DK-PRECISE) is a randomized, double-blinded, placebo-controlled trial. A total of 491 males and females aged 60-74 years were randomized to 100 μg (n=124), 200 μg (n=122), or 300 μg (n=119) selenium-enriched yeast or matching yeast-based placebo tablets (n=126). A total of 361 participants, equally distributed across treatment groups, completed the 5-year intervention period. Plasma samples were analyzed for selenium and serum samples for TSH, free triiodothyronine (FT3), and free thyroxine (FT4) at baseline, and after 6 months, and 5 years of supplementation. Plasma selenium concentrations increased significantly and dose-dependently in treatment groups receiving selenium (P<0.001). Serum TSH and FT4 concentrations decreased significantly and dose-dependently by 0.066 mIU/l (P=0.010) and 0.11 pmol/l (P=0.015), respectively, per 100 μg/day increase, with insignificant differences between 6 months and 5 years. No significant effects were found for FT3 and FT3:FT4 ratio. In euthyroid subjects, selenium supplementation minutely and dose-dependently affects thyroid function, when compared with placebo, by decreasing serum TSH and FT4 concentrations. Based on these findings, selenium supplementation is not warranted under conditions of marginal selenium deficiency. However, a role for selenium supplementation in the treatment of autoimmune thyroid diseases is still unresolved. © 2015 European Society of Endocrinology.

A Multi-country Study of the Household Willingness-to-Pay for Dengue Vaccines: Household Surveys in Vietnam, Thailand, and Colombia

PubMed Central

Lee, Jung-Seok

2015-01-01

Background The rise in dengue fever cases and the absence of dengue vaccines will likely cause governments to consider various types of effective means for controlling the disease. Given strong public interests in potential dengue vaccines, it is essential to understand the private economic benefits of dengue vaccines for accelerated introduction of vaccines into the public sector program and private markets of high-risk countries. Methodology/Principal Findings A contingent valuation study for a hypothetical dengue vaccine was administered to 400 households in a multi-country setting: Vietnam, Thailand, and Colombia. All respondents received a description of the hypothetical dengue vaccine scenarios of 70% or 95% effectiveness for 10 or 30 years with a three dose series. Five price points were determined after pilot tests in order to reflect different local situations such as household income levels and general perceptions towards dengue fever. We adopted either Poisson or negative binomial regression models to calculate average willingness-to-pay (WTP), as well as median WTP. We found that there is a significant demand for dengue vaccines. The parametric median WTP is $26.4 ($8.8 per dose) in Vietnam, $70.3 ($23.4 per dose) in Thailand, and $23 ($7.7 per dose) in Colombia. Our study also suggests that respondents place more value on vaccinating young children than school age children and adults. Conclusions/Significance Knowing that dengue vaccines are not yet available, our study provides critical information to both public and private sectors. The study results can be used to ensure broad coverage with an affordable price and incorporated into cost benefit analyses, which can inform prioritization of alternative health interventions at the national level. PMID:26030922

The impact of oral probiotics on vaginal Group B Streptococcal colonisation rates in pregnant women: A pilot randomised control study.

PubMed

Olsen, Paula; Williamson, Moira; Traynor, Victoria; Georgiou, Chris

2018-02-01

To perform a pilot project to determine if this research design was appropriate to explore potential causal relationships between oral probiotic use and vaginal Group B Streptococcal (GBS) colonisation rates in pregnant women. Thirty-four GBS-positive women at 36 weeks pregnant were recruited. The participants were randomly allocated to the control group, who received standard antenatal care, or to the intervention group, who received standard antenatal care and a daily oral dose of probiotics for three weeks or until they gave birth. A vaginal GBS swab was collected three weeks post consent or during labour. No significant difference was found in vaginal GBS rates between the control and intervention groups. Only seven of 21 women in the intervention group completed the entire 21days of probiotics. A subgroup analysis, including only those who had completed 14days or more of probiotics (n=16), also showed no significant difference in vaginal GBS when compared to the control. The findings did show significantly more vaginal commensals in the probiotics group (p=0.048). Five possible reasons for the lack of significant results are: the length of the intervention was too short; the dosage of the probiotics was too low; the wrong strains of probiotics were used; the sample size was inadequate; or oral probiotics are ineffective in impacting vaginal GBS. The finding of a significant increase of vaginal commensals in women who completed 14days or more of probiotics supports the potential of probiotics to impact vaginal GBS in pregnancy. Copyright © 2017 Australian College of Midwives. Published by Elsevier Ltd. All rights reserved.

Accuracy of Monte Carlo simulations compared to in-vivo MDCT dosimetry.

PubMed

Bostani, Maryam; Mueller, Jonathon W; McMillan, Kyle; Cody, Dianna D; Cagnon, Chris H; DeMarco, John J; McNitt-Gray, Michael F

2015-02-01

The purpose of this study was to assess the accuracy of a Monte Carlo simulation-based method for estimating radiation dose from multidetector computed tomography (MDCT) by comparing simulated doses in ten patients to in-vivo dose measurements. MD Anderson Cancer Center Institutional Review Board approved the acquisition of in-vivo rectal dose measurements in a pilot study of ten patients undergoing virtual colonoscopy. The dose measurements were obtained by affixing TLD capsules to the inner lumen of rectal catheters. Voxelized patient models were generated from the MDCT images of the ten patients, and the dose to the TLD for all exposures was estimated using Monte Carlo based simulations. The Monte Carlo simulation results were compared to the in-vivo dose measurements to determine accuracy. The calculated mean percent difference between TLD measurements and Monte Carlo simulations was -4.9% with standard deviation of 8.7% and a range of -22.7% to 5.7%. The results of this study demonstrate very good agreement between simulated and measured doses in-vivo. Taken together with previous validation efforts, this work demonstrates that the Monte Carlo simulation methods can provide accurate estimates of radiation dose in patients undergoing CT examinations.

Functional test measures as risk indicators for low back pain among fixed-wing military pilots.

PubMed

Honkanen, Tuomas; Kyröläinen, H; Avela, J; Mäntysaari, M

2017-02-01

The purpose of this study was to find out the risk value of functional fitness test (FFT) results for low back pain (LBP) among fixed-wing military pilots. A total of 104 male military pilots were recruited for this study. The study was conducted with a self-administered questionnaire and FFT. The functional tests were performed in the beginning of study (baseline). The questionnaire was carried out at the baseline and 5 years later. The isometric low back endurance test result was associated with physical activity-related LBP experienced 5 years later. Demographic information was not associated with LBP. The prevalence of overall LBP was 71% and the flight-related LBP prevalence was 31% at the baseline. Our findings show that LBP among military pilots is a common problem but it is also associated with tasks other than flying. The functional test results were not associated with flight-related LBP but adequate isometric back endurance may have protective role in LBP caused in physical activities. When trying to find the pilots with increased risk of flight-related LBP, a more sensitive set of tests should be considered. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Pilot-scale test for electron beam purification of flue gas from coal-combustion boiler

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hashimoto, Shoji; Namba, Hideki; Tokunaga, Okihiro

1995-06-01

Construction of a pilot plant of the treatment capacity of 12,000 m{sup 3}N/h flue gas was completed in November, 1992 in the Shin-Nagoya Thermal Power Station, Nagoya for electron beam purification of flue-gas from coal combustion boiler and the operation had been continued during one year. The results obtained In the tests shows that the target removal efficiency for SO{sub 2} (94 %) and for NO{sub x} (80 %) was achieved with appropriate operation conditions (electron beam dose, temperature, amount of ammonia etc.). The effective collection of powdery by-products was performed by an electrostatic precipitator.

Building a Sustainable Future: A Report on the Environmental Protection Agency's Brownfields Sustainability Pilots

EPA Pesticide Factsheets

This report describes each of the Brownfields Sustainability Pilots and provides findings and recommendations for future projects. It is intended for use by people, communities, organizations, and agencies helping make brownfields more sustainable.

Remote Infrared Audible Signage (RIAS) Pilot Program : evaluation report

DOT National Transportation Integrated Search

2009-09-01

This report presents evaluation findings on the Remote Infrared Audible Signage (RIAS) Pilot Program in the Puget Sound Region of Washington. The installation, demonstration and evaluation of RIAS were required by a provision in the Safe, Accountable...

Mindfulness Meditation and Cognitive Behavioral Therapy Intervention Reduces Pain Severity and Sensitivity in Opioid-Treated Chronic Low Back Pain: Pilot Findings from a Randomized Controlled Trial

PubMed Central

Burzinski, Cindy A.; Cox, Jennifer; Kloke, John; Stegner, Aaron; Cook, Dane B.; Singles, Janice; Mirgain, Shilagh; Coe, Christopher L.; Bačkonja, Miroslav

2016-01-01

Objective. To assess benefits of mindfulness meditation and cognitive behavioral therapy (CBT)-based intervention for opioid-treated chronic low back pain (CLBP). Design. 26-week parallel-arm pilot randomized controlled trial (Intervention and Usual Care versus Usual Care alone). Setting. Outpatient. Subjects. Adults with CLBP, prescribed ≥30 mg/day of morphine-equivalent dose (MED) for at least 3 months. Methods. The intervention comprised eight weekly group sessions (meditation and CLBP-specific CBT components) and 30 minutes/day, 6 days/week of at-home practice. Outcome measures were collected at baseline, 8, and 26 weeks: primary-pain severity (Brief Pain Inventory) and function/disability (Oswestry Disability Index); secondary-pain acceptance, opioid dose, pain sensitivity to thermal stimuli, and serum pain-sensitive biomarkers (Interferon-γ; Tumor Necrosis Factor-α; Interleukins 1ß and 6; C-reactive Protein). Results. Thirty-five (21 experimental, 14 control) participants were enrolled and completed the study. They were 51.8 ± 9.7 years old, 80% female, with severe CLBP-related disability (66.7 ± 11.4), moderate pain severity (5.8 ± 1.4), and taking 148.3 ± 129.2 mg/day of MED. Results of the intention-to-treat analysis showed that, compared with controls, the meditation-CBT group reduced pain severity ratings during the study (P = 0.045), with between-group difference in score change reaching 1 point at 26 weeks (95% Confidence Interval: 0.2,1.9; Cohen’s d = 0.86), and decreased pain sensitivity to thermal stimuli (P < 0.05), without adverse events. Exploratory analyses suggested a relationship between the extent of meditation practice and the magnitude of intervention benefits. Conclusions. Meditation-CBT intervention reduced pain severity and sensitivity to experimental thermal pain stimuli in patients with opioid-treated CLBP. PMID:26968850

The effect of five day dosing with THCV on THC-induced cognitive, psychological and physiological effects in healthy male human volunteers: A placebo-controlled, double-blind, crossover pilot trial.

PubMed

Englund, Amir; Atakan, Zerrin; Kralj, Aleksandra; Tunstall, Nigel; Murray, Robin; Morrison, Paul

2016-02-01

Cannabis is mostly grown under illegal and unregulated circumstances, which seems to favour a product increasingly high in its main cannabinoid ∆-9-tetrahydrocannabinol (THC). ∆-9-tetrahydrocannabivarin (THCV) is a relatively untested cannabinoid which is said to be a cannabinoid receptor neutral antagonist, and may inhibit the effects of THC. To explore the safety and tolerability of repeated THCV administration and its effects on symptoms normally induced by THC in a sample of healthy volunteers. Ten male cannabis users (<25 use occasions) were recruited for this within-subjects, placebo-controlled, double-blind, cross-over pilot study. 10mg oral pure THCV or placebo were administered daily for five days, followed by 1mg intravenous THC on the fifth day. THCV was well tolerated and subjectively indistinguishable from placebo. THC did not significantly increase psychotic symptoms, paranoia or impair short-term memory, while still producing significant intoxicating effects. Delayed verbal recall was impaired by THC and only occurred under placebo condition (Z=-2.201, p=0.028), suggesting a protective effect of THCV. THCV also inhibited THC-induced increased heart rate (Z=-2.193, p=0.028). Nine out of ten participants reported THC under THCV condition (compared to placebo) to be subjectively weaker or less intense (χ(2)=6.4, p=0.011). THCV in combination with THC significantly increased memory intrusions (Z=-2.155, p=0.031). In this first study of THC and THCV, THCV inhibited some of the well-known effects of THC, while potentiating others. These findings need to be interpreted with caution due to a small sample size and lack of THC-induced psychotomimetic and memory-impairing effect, probably owing to the choice of dose. © The Author(s) 2015.

Mindfulness Meditation and Cognitive Behavioral Therapy Intervention Reduces Pain Severity and Sensitivity in Opioid-Treated Chronic Low Back Pain: Pilot Findings from a Randomized Controlled Trial.

PubMed

Zgierska, Aleksandra E; Burzinski, Cindy A; Cox, Jennifer; Kloke, John; Stegner, Aaron; Cook, Dane B; Singles, Janice; Mirgain, Shilagh; Coe, Christopher L; Bačkonja, Miroslav

2016-10-01

To assess benefits of mindfulness meditation and cognitive behavioral therapy (CBT)-based intervention for opioid-treated chronic low back pain (CLBP). 26-week parallel-arm pilot randomized controlled trial (Intervention and Usual Care versus Usual Care alone). Outpatient. Adults with CLBP, prescribed ≥30 mg/day of morphine-equivalent dose (MED) for at least 3 months. The intervention comprised eight weekly group sessions (meditation and CLBP-specific CBT components) and 30 minutes/day, 6 days/week of at-home practice. Outcome measures were collected at baseline, 8, and 26 weeks: primary-pain severity (Brief Pain Inventory) and function/disability (Oswestry Disability Index); secondary-pain acceptance, opioid dose, pain sensitivity to thermal stimuli, and serum pain-sensitive biomarkers (Interferon-γ; Tumor Necrosis Factor-α; Interleukins 1ß and 6; C-reactive Protein). Thirty-five (21 experimental, 14 control) participants were enrolled and completed the study. They were 51.8 ± 9.7 years old, 80% female, with severe CLBP-related disability (66.7 ± 11.4), moderate pain severity (5.8 ± 1.4), and taking 148.3 ± 129.2 mg/day of MED. Results of the intention-to-treat analysis showed that, compared with controls, the meditation-CBT group reduced pain severity ratings during the study (P = 0.045), with between-group difference in score change reaching 1 point at 26 weeks (95% Confidence Interval: 0.2,1.9; Cohen's d = 0.86), and decreased pain sensitivity to thermal stimuli (P < 0.05), without adverse events. Exploratory analyses suggested a relationship between the extent of meditation practice and the magnitude of intervention benefits. Meditation-CBT intervention reduced pain severity and sensitivity to experimental thermal pain stimuli in patients with opioid-treated CLBP. © 2016 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Pretreatment with myo-inositol in non polycystic ovary syndrome patients undergoing multiple follicular stimulation for IVF: a pilot study

PubMed Central

2012-01-01

Background Aim of this pilot study is to examine the effects of myo-inositol administration on ovarian response and oocytes and embryos quality in non PolyCystic Ovary Syndrome (PCOS) patients undergoing multiple follicular stimulation and in vitro insemination by conventional in vitro fertilization or by intracytoplasmic sperm injection. Methods One hundred non-PCOS women aged <40 years and with basal FSH <10 mUI/ml were down-regulated with triptorelin acetate from the mid-luteal phase for 2 weeks, before starting the stimulation protocol for oocytes recovery. All patients received rFSH, at a starting dose of 150 IU for 6 days. The dose was subsequently adjusted according to individual response. Group B (n = 50) received myo-inositol and folic acid for 3 months before the stimulation period and then during the stimulation itself. Group A (n-50) received only folic acid as additional treatment in the 3 months before and through treatment. Results Total length of the stimulation was similar between the two groups. Nevertheless, total amount of gonadotropins used to reach follicular maturation was found significantly lower in group B. In addition, the number of oocytes retrieved was significantly reduced in the group pretreated with myo-inositol. Clinical pregnancy and implantation rate were not significantly different in the two groups. Conclusions Our findings suggest that the addition of myo-inositol to folic acid in non PCOS-patients undergoing multiple follicular stimulation for in-vitro fertilization may reduce the numbers of mature oocytes and the dosage of rFSH whilst maintaining clinical pregnancy rate. Further, a trend in favor of increased incidence of implantation in the group pretreated with myo-inositol was apparent in this study. Further investigations are warranted to clarify this pharmacological approach, and the benefit it may hold for patients. PMID:22823904

Effects of a short duration, high dose contact improvisation dance workshop on Parkinson disease: a pilot study.

PubMed

Marchant, David; Sylvester, Jennifer L; Earhart, Gammon M

2010-10-01

This study explored the feasibility and possible benefits of contact improvisation (CI) as an exercise intervention for individuals with PD. This was an uncontrolled pilot study. Eleven people with PD (H&Y=2.4 ± 0.4) participated in a workshop of 10 1.5-h CI classes over 2 weeks, dancing with previously trained student CI dancers. Measures of disease severity, balance, functional mobility, and gait were compared 1 week before and after the workshop. Participants demonstrated improvements on the Unified Parkinson Disease Rating Scale-Motor Subsection and Berg balance scores, along with increased swing and decreased stance percentages during walking. Backward step length also increased. Participants expressed a high level of enjoyment and interest in taking future CI classes. This pilot study supports the feasibility of CI as an intervention to address mobility limitations associated with PD. Copyright © 2010 Elsevier Ltd. All rights reserved.

Teaching treatment planning for protons with educational open-source software: experience with FoCa and matRad.

PubMed

Sanchez-Parcerisa, Daniel; Udías, Jose

2018-05-12

Open-source, MATLAB-based treatment planning systems FoCa and matRAD were used in a pilot project for training prospective medical physicists and postgraduate physics students in treatment planning and beam modeling techniques for proton therapy. In the four exercises designed, students learnt how proton pencil beams are modeled and how dose is calculated in three-dimensional voxelized geometries, how pencil beam scanning plans (PBS) are constructed, the rationale behind the choice of spot spacing in patient plans, and the dosimetric differences between photon IMRT and proton PBS plans. Sixty students of two courses participated in the pilot project, with over 90% of satisfactory rating from student surveys. The pilot experience will certainly be continued. © 2018 The Authors. Journal of Applied Clinical Medical Physics published by Wiley Periodicals, Inc. on behalf of American Association of Physicists in Medicine.

A pilot study of dose-intensified procarbazine, CCNU, vincristine for poor prognosis brain tumors utilizing fibronectin-assisted, retroviral-mediated modification of CD34+ peripheral blood cells with O6-methylguanine DNA methyltransferase.

PubMed

Cornetta, K; Croop, J; Dropcho, E; Abonour, R; Kieran, M W; Kreissman, S; Reeves, L; Erickson, L C; Williams, D A

2006-09-01

Administration of chemotherapy is often limited by myelosuppression. Expression of drug-resistance genes in hematopoietic cells has been proposed as a means to decrease the toxicity of cytotoxic agents. In this pilot study, we utilized a retroviral vector expressing methylguanine DNA methyltransferase (MGMT) to transduce hematopoietic progenitors, which were subsequently used in the setting of alkylator therapy (procarbazine, CCNU, vincristine (PCV)) for poor prognosis brain tumors. Granulocyte colony-stimulating factor (G-CSF)-mobilized peripheral blood progenitor cells were collected by apheresis and enriched for CD34+ expression. Nine subjects were infused with CD34+-enriched cells treated in a transduction procedure involving a 4-day exposure to cytokines with vector exposure on days 3 and 4. No major adverse event was related to the gene therapy procedure. Importantly, the engraftment kinetics of the treated product was similar to unmanipulated peripheral blood stem cells, suggesting that the ex vivo manipulation did not significantly reduce engrafting progenitor cell function. Gene-transduced cells were detected in all subjects. Although the level and duration was limited, patients receiving cells transduced using fibronectin 'preloaded' with virus supernatant appeared to show improved in vivo marking frequency. These findings demonstrate the feasibility and safety of utilizing MGMT-transduced CD34+ peripheral blood progenitor cells in the setting of chemotherapy.

A pilot study assessing pharmacokinetics and tolerability of oral and intravenous baclofen in healthy adult volunteers.

PubMed

Agarwal, Suresh K; Kriel, Robert L; Cloyd, James C; Coles, Lisa D; Scherkenbach, Lisa A; Tobin, Michael H; Krach, Linda E

2015-01-01

Our objective was to characterize baclofen pharmacokinetics and safety given orally and intravenously. Twelve healthy subjects were enrolled in a randomized, open-label, crossover study and received single doses of baclofen: 3 or 5 mg given intravenously and 5 or 10 mg taken orally with a 48-hour washout. Blood samples for baclofen analysis were collected pre-dose and at regular intervals up to 24 hours post-dose. Clinical response was assessed by sedation scores, ataxia, and nystagmus. Mean absolute bioavailability of oral baclofen was 74%. Dose-adjusted areas under the curve between the oral and intravenous arms were statistically different (P = .0024), whereas area under the curve variability was similar (coefficient of variation: 18%-24%). Adverse effects were mild in severity and not related to either dose or route of administration. Three- and 5-mg intravenous doses of baclofen were well tolerated. Seventy-four percent oral bioavailability indicates that smaller doses of intravenous baclofen are needed to attain comparable total drug exposures. © The Author(s) 2014.

Evaluation of a Pilot Project on Information and Communication Technology for Rural Education Development: A Cofimvaba Case Study on the Educational Use of Tablets

ERIC Educational Resources Information Center

Phiri, Acheson Charles; foko, Thato; Mahwai, Nare

2014-01-01

In an endeavour to find solutions to the country's improving but ailing education system the South African government through some of its departments is attempting to find out if the introduction of technology in the class room has the potential to improve teaching and learning. The paper is based on a pilot study currently underway in Cofimvaba…

Behind the Power Curve: The Regular Air Force Pilots Shortages Effect on Air National Guard Fighter Squadrons

DTIC Science & Technology

2016-04-01

in 2017. Recall from the previous retention section that there is nearly a 50% drop in the total AC fighter pilot inventory available to separate...8 Figure 3. Total Fighter Pilots by Year Group ...................................................................11 Figure 4...important for the Total Force to find an equitable balance and refine the forcing functions to produce, absorb, and sustain the dwindling fighter

Pilot Scale Production and Testing of a Recombinant Staphylococcal Enterotoxin (SEB) Triple Mutant

DTIC Science & Technology

2017-09-01

1 PILOT-SCALE PRODUCTION AND TESTING OF A RECOMBINANT STAPHYLOCOCCAL ENTEROTOXIN (SEB) TRIPLE MUTANT ECBC...Disclaimer The findings in this report are not to be construed as an official Department of the Army position unless so designated by other authorizing...TYPE Final 3. DATES COVERED (From - To) Mar 2010 – Dec 2011 4. TITLE AND SUBTITLE Pilot-Scale Production and Testing of a Recombinant

Dose-Dependent Cannabis Use, Depressive Symptoms, and FAAH Genotype Predict Sleep Quality in Emerging Adults: A Pilot Study

PubMed Central

Maple, Kristin E.; McDaniel, Kymberly A.; Shollenbarger, Skyler G.; Lisdahl, Krista M.

2017-01-01

Background Cannabis has been shown to affect sleep in humans. Findings from animal studies indicate that higher endocannabinoid levels promote sleep, suggesting that chronic use of cannabis, which downregulates endocannabinoid activity, may disrupt sleep. Objectives This study sought to determine if past year cannabis use and genes that regulate endocannabinoid signaling, FAAH rs324420 and CNR1 rs2180619, predicted sleep quality. As depression has been previously associated with both cannabis and sleep, the secondary aim was to determine if depressive symptoms moderated or mediated these relationships. Methods Data were collected from 41 emerging adult (ages 18–25) cannabis users. Exclusion criteria included Axis I disorders (besides SUD) and medical and neurologic disorders. Relationships were tested using multiple regressions, controlling for demographic variables, past year substance use, and length of cannabis abstinence. Results Greater past year cannabis use and FAAH C/C genotype were associated with poorer sleep quality. CNR1 genotype did not significantly predict sleep quality. Depressive symptoms moderated the relationship between cannabis use and sleep at a non-significant trend level, such that participants with the greatest cannabis use and most depressive symptoms reported the most impaired sleep. Depressive symptoms mediated the relationship between FAAH genotype and sleep quality. Conclusions This study demonstrates a dose-dependent relationship between chronic cannabis use and reported sleep quality, independent of abstinence length. Furthermore, it provides novel evidence that depressive symptoms mediate the relationship between FAAH genotype and sleep quality in humans. These findings suggest potential targets to impact sleep disruptions in cannabis users. PMID:27074158

The safety significance of aircraft accident post mortem findings.

DOT National Transportation Integrated Search

1969-10-01

A review of post mortem examinations obtained in 1968 of pilot victims of general aviation aircraft accidents reveals that 51 percent of the pilot victims were studied by pathologists. The post mortem examination population above was taken from 687 p...

Findings of the Canadian vehicle fuel pilot survey

DOT National Transportation Integrated Search

2004-10-01

This report presents the results of a pilot survey conducted by Statistics Canada to measure the fuel consumption of on-road motor vehicles registered in Canada. This study was carried out in connection with the Canadian Vehicle Survey (CVS) which co...

Integrated vehicle-based safety systems (IVBSS) : heavy truck extended pilot test summary report.

DOT National Transportation Integrated Search

2009-05-01

This report describes the findings and recommendations from the heavy-truck (HT) extended pilot test (EPT) conducted by University of Michigan Transportation Research Institute (UMTRI) and its partners under the Integrated Vehicle-Based Safety System...

A simple LC-MS/MS method using HILIC chromatography for the determination of fosfomycin in plasma and urine: application to a pilot pharmacokinetic study in humans.

PubMed

Parker, Suzanne L; Lipman, Jeffrey; Roberts, Jason A; Wallis, Steven C

2015-02-01

A high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) method, using hydrophilic interaction liquid chromatography (HILIC) chromatography for the analysis of fosfomycin in human plasma and urine, has been developed and validated. The plasma method uses a simple protein precipitation using a low volume sample (10 μL) and is suitable for the concentration range of 1 to 2000 μg/mL. The urine method involves a simple dilution of 10 μL of sample and is suitable for a concentration range of 0.1 to 10 mg/mL. The plasma and urine results, reported, respectively, are for recovery (68, 72%), inter-assay precision (≤9.1%, ≤8.1%) and accuracy (range -7.2 to 3.3%, -1.9 to 1.6%), LLOQ precision (4.7%, 3.1%) and accuracy (1.7% and 1.2%), and includes investigations into the linearity, stability and matrix effects. The method was used in a pilot pharmacokinetic study of a critically ill patient receiving i.v. fosfomycin, which measured a maximum and minimum plasma concentration of 222 μg/mL and 172 μg/mL, respectively, after the initial dose, and a maximum and minimum plasma concentration of 868 μg/mL and 591μg/mL, respectively, after the fifth dose. The urine concentration was 2.03 mg/mL after the initial dose and 0.29 mg/mL after the fifth dose. Copyright © 2014 Elsevier B.V. All rights reserved.

A pilot study of discontinuous, insulin-like growth factor 1-dosing growth hormone treatment in young children with FGFR3 N540K-mutated hypochondroplasia.

PubMed

Rothenbuhler, Anya; Linglart, Agnès; Piquard, Catherine; Bougnères, Pierre

2012-05-01

To assess the growth promoting effect of a recombinant growth hormone (rGH) treatment protocol adjusted on insulin-like growth factor 1 (IGF-1) dosing in children affected by the most severe forms of FGFR3 N540K-mutated hypochondroplasia. Midterm results of an open-label, single-center, nonrandomized, 2003-2020 pilot trial to final stature, including 6 children (mean age, 2.6 ± 0.7 years; mean height SDS, -3.0 ± 0.5) with the N540K mutation of FGFR3 gene who received an rGH dosage titrated to an IGF-1 level close to 1.5 SDS of the normal range. rGH therapy was interrupted 1 day per week, 1 month per year, and 6 months every 2 years. The mean height SDS increased by 1.9 during the 6.1 ± 0.9-year study period, reaching -0.8 to -1.3 at age 8.7 ± 1 years. The mean±SDS baseline IGF-1 value was -1.6 ± 0.5 before rGH treatment and 1.4±0.3 during the last year of observation. The average cumulative rGH dose was 0.075 ± 0.018 mg/kg/day (range, 0.059-0.100 mg/kg/day). Trunk/leg disproportion was improved. IGF-1-dosing rGH treatment durably improves growth and reduces body disproportion in children with severe forms of hypochondroplasia. Copyright © 2012. Published by Mosby, Inc.

Impact of Bromocriptine-QR Therapy on Glycemic Control and Daily Insulin Requirement in Type 2 Diabetes Mellitus Subjects Whose Dysglycemia Is Poorly Controlled on High-Dose Insulin: A Pilot Study.

PubMed

Roe, Erin D; Chamarthi, Bindu; Raskin, Philip

2015-01-01

The concurrent use of a postprandial insulin sensitizing agent, such as bromocriptine-QR, a quick release formulation of bromocriptine, a dopamine D2 receptor agonist, may offer a strategy to improve glycemic control and limit/reduce insulin requirement in type 2 diabetes (T2DM) patients on high-dose insulin. This open label pilot study evaluated this potential utility of bromocriptine-QR. Ten T2DM subjects on metformin (1-2 gm/day) and high-dose (TDID ≥ 65 U/day) basal-bolus insulin were enrolled to receive once daily (morning) bromocriptine-QR (1.6-4.8 mg/day) for 24 weeks. Subjects with at least one postbaseline HbA1c measurement (N = 8) were analyzed for change from baseline HbA(1c), TDID, and postprandial glucose area under the curve of a four-hour mixed meal tolerance test (MMTT). Compared to the baseline, average HbA1c decreased 1.76% (9.74 ± 0.56 to 7.98 ± 0.36, P = 0.01), average TDID decreased 27% (199 ± 33 to 147 ± 31, P = 0.009), and MMTT AUC(60-240) decreased 32% (P = 0.04) over the treatment period. The decline in HbA(1c) and TDID was observed at 8 weeks and sustained over the remaining 16-week study duration. In this study, bromocriptine-QR therapy improved glycemic control and meal tolerance while reducing insulin requirement in T2DM subjects poorly controlled on high-dose insulin therapy.

Reduced Pro-Inflammatory Cytokines after Eight Weeks of Low-Dose Naltrexone for Fibromyalgia.

PubMed

Parkitny, Luke; Younger, Jarred

2017-04-18

Fibromyalgia (FM) is a complex, multi-symptom condition that predominantly affects women. The majority of those affected are unlikely to gain significant symptomatic control from the few treatments that are approved for FM. In this 10-week, single-blind, crossover trial we tested the immune effects of eight weeks of oral administration of low-dose naltrexone (LDN). We enrolled eight women with an average age of 46 years, symptom severity of 62 out of 100, and symptom duration of 14 years. We found that LDN was associated with reduced plasma concentrations of interleukin (IL)-1β, IL-1Ra, IL-2, IL-4, IL-5, IL-6, IL-10, IL-12p40, IL-12p70, IL-15, IL-17A, IL-27, interferon (IFN)-α, transforming growth factor (TGF)-α, TGF-β, tumor necrosis factor (TNF)-α, and granulocyte-colony stimulating factor (G-CSF). We also found a 15% reduction of FM-associated pain and an 18% reduction in overall symptoms. The findings of this pilot trial suggest that LDN treatment in fibromyalgia is associated with a reduction of several key pro-inflammatory cytokines and symptoms. The potential role of LDN as an atypical anti-inflammatory medication should be explored further.

Removal of micropollutants with coarse-ground activated carbon for enhanced separation with hydrocyclone classifiers.

PubMed

Otto, N; Platz, S; Fink, T; Wutscherk, M; Menzel, U

2016-01-01

One key technology to eliminate organic micropollutants (OMP) from wastewater effluent is adsorption using powdered activated carbon (PAC). To avoid a discharge of highly loaded PAC particles into natural water bodies a separation stage has to be implemented. Commonly large settling tanks and flocculation filters with the application of coagulants and flocculation aids are used. In this study, a multi-hydrocyclone classifier with a downstream cloth filter has been investigated on a pilot plant as a space-saving alternative with no need for a dosing of chemical additives. To improve the separation, a coarser ground PAC type was compared to a standard PAC type with regard to elimination results of OMP as well as separation performance. With a PAC dosing rate of 20 mg/l an average of 64.7 wt% of the standard PAC and 79.5 wt% of the coarse-ground PAC could be separated in the hydrocyclone classifier. A total average separation efficiency of 93-97 wt% could be reached with a combination of both hydrocyclone classifier and cloth filter. Nonetheless, the OMP elimination of the coarse-ground PAC was not sufficient enough to compete with the standard PAC. Further research and development is necessary to find applicable coarse-grained PAC types with adequate OMP elimination capabilities.

Liver function and DNA integrity in hepatocytes of rats evaluated after treatments with strawberry tree (Arbutus unedo L.) water leaf extract and arbutin.

PubMed

Jurica, Karlo; Benković, Vesna; Sikirić, Sunčana; Kopjar, Nevenka; Brčić Karačonji, Irena

2018-06-07

Due to their beneficial health effects, strawberry tree (Arbutus unedo L.) leaves have for decades been used as herbal remedy in countries of the Mediterranean region. This pilot study is the first to investigate the liver function and DNA integrity in rat hepatocytes evaluated after 14 and 28 day treatments with strawberry tree water leaf extract and arbutin, administered per os to Lewis rats of both genders at a daily dose 200 mg/kg b.w. We focused on two types of biomarkers: enzyme serum markers of liver function (AST, ALT, and LDH), and primary DNA damage in the liver cells, which was estimated using the alkaline comet assay. At the tested dose, strawberry tree water leaf extract showed acceptable biocompatibility with liver tissue both in male and female rats, especially after shorter exposure. Our results also suggest that oral administration of single arbutin to rats was not associated with significant impairments either in the liver function or DNA integrity in hepatocytes. Considering that prolonged exposure to the tested compounds revealed minor changes in the studied biomarkers, future in vivo studies have to further clarify the biological and physiological relevance of these findings.

Increased frequency of chromosome translocations in airline pilots with long-term flying experience

PubMed Central

Yong, L C; Sigurdson, A J; Ward, E M; Waters, M A; Whelan, E A; Petersen, M R; Bhatti, P; Ramsey, M J; Ron, E; Tucker, J D

2008-01-01

Background Chromosome translocations are an established biomarker of cumulative exposure to external ionising radiation. Airline pilots are exposed to cosmic ionising radiation, but few flight crew studies have examined translocations in relation to flight experience. Methods We determined the frequency of translocations in the peripheral blood lymphocytes of 83 airline pilots and 50 comparison subjects (mean age 47 and 46 years, respectively). Translocations were scored in an average of 1039 cell equivalents (CE) per subject using fluorescence in situ hybridisation (FISH) whole chromo-some painting and expressed per 100 CE. Negative binomial regression models were used to assess the relationship between translocation frequency and exposure status and flight years, adjusting for age, diagnostic x ray procedures, and military flying. Results There was no significant difference in the adjusted mean translocation frequency of pilots and comparison subjects (0.37 (SE 0.04) vs 0.38 (SE 0.06) translocations/100 CE, respectively). However, among pilots, the adjusted translocation frequency was significantly associated with flight years (p = 0.01) with rate ratios of 1.06 (95% CI 1.01 to 1.11) and 1.81 (95% CI 1.16 to 2.82) for a 1- and 10-year incremental increase in flight years, respectively. The adjusted rate ratio for pilots in the highest compared to the lowest quartile of flight years was 2.59 (95% CI 1.26 to 5.33). Conclusions This data suggests that pilots with long-term flying experience may be exposed to biologically significant doses of ionising radiation. Epidemiological studies with longer follow-up of larger cohorts of pilots with a wide range of radiation exposure levels are needed to clarify the relationship between cosmic radiation exposure and cancer risk. PMID:19074211

Increased frequency of chromosome translocations in airline pilots with long-term flying experience.

PubMed

Yong, L C; Sigurdson, A J; Ward, E M; Waters, M A; Whelan, E A; Petersen, M R; Bhatti, P; Ramsey, M J; Ron, E; Tucker, J D

2009-01-01

Chromosome translocations are an established biomarker of cumulative exposure to external ionising radiation. Airline pilots are exposed to cosmic ionising radiation, but few flight crew studies have examined translocations in relation to flight experience. We determined the frequency of translocations in the peripheral blood lymphocytes of 83 airline pilots and 50 comparison subjects (mean age 47 and 46 years, respectively). Translocations were scored in an average of 1039 cell equivalents (CE) per subject using fluorescence in situ hybridisation (FISH) whole chromosome painting and expressed per 100 CE. Negative binomial regression models were used to assess the relationship between translocation frequency and exposure status and flight years, adjusting for age, diagnostic x ray procedures, and military flying. There was no significant difference in the adjusted mean translocation frequency of pilots and comparison subjects (0.37 (SE 0.04) vs 0.38 (SE 0.06) translocations/100 CE, respectively). However, among pilots, the adjusted translocation frequency was significantly associated with flight years (p = 0.01) with rate ratios of 1.06 (95% CI 1.01 to 1.11) and 1.81 (95% CI 1.16 to 2.82) for a 1- and 10-year incremental increase in flight years, respectively. The adjusted rate ratio for pilots in the highest compared to the lowest quartile of flight years was 2.59 (95% CI 1.26 to 5.33). Our data suggests that pilots with long-term flying experience may be exposed to biologically significant doses of ionising radiation. Epidemiological studies with longer follow-up of larger cohorts of pilots with a wide range of radiation exposure levels are needed to clarify the relationship between cosmic radiation exposure and cancer risk.

Symptoms of fatigue and coping strategies in maritime pilotage.

PubMed

Chambers, Timothy P; Main, Luana C

2015-01-01

Little is known regarding the symptoms of fatigue that maritime pilots experience during shift work. Moreover, the strategies these individuals use to cope with the onset of fatigue are also unknown. The current study explored the symptoms of fatigue and coping strategies experienced by maritime pilots when on-shift. Fifty maritime pilots were recruited via an advertisement in the national association's quarterly newsletter (Mage = 51.42; SD = 9.81). Participants responded to a modified version of the questionnaire used with aviation pilots that assessed overall fatigue, and the symptoms pilots associated with fatigue on duty. Methods pilots used to cope with fatigue before shift and when on the bridge were also assessed. There were significant effects for pilot vitality on 4 categories of fatigue: cognitive dysfunction; emotional disturbance; mean physical effects; and sleepiness. There were no significant effects for vitality on any of the self-reported coping strategy factors. The findings indicated that maritime pilots experience a variety of physical, behavioural, and cognitive fatigue symptoms when on shift. Some of these symptoms are similar to those reported by aviation pilots. However, unlike aviation pilots, maritime pilots reported utilising self-sufficient coping strategies to deal with the experience of fatigue.

Guidelines for the Clinical Evaluation of Psychoactive Drugs in Infants and Children.

ERIC Educational Resources Information Center

Food and Drug Administration (DHEW), Washington, DC.

These guidelines are intended to help those who design and conduct investigations of psychopharmacologic agents in children. A progression of studies in four phases is advocated. First, early short term studies should establish single and multiple dose safety baselines. Second, early pilot efficacy studies may be initiated jointly with longer…

UV/TiO2 photocatalytic disinfection of carbon-bacteria complexes in activated carbon-filtered water: Laboratory and pilot-scale investigation.

PubMed

Zhao, Jin Hui; Chen, Wei; Zhao, Yaqian; Liu, Cuiyun; Liu, Ranbin

2015-01-01

The occurrence of carbon-bacteria complexes in activated carbon filtered water has posed a public health problem regarding the biological safety of drinking water. The application of combined process of ultraviolet radiation and nanostructure titanium dioxide (UV/TiO2) photocatalysis for the disinfection of carbon-bacteria complexes were assessed in this study. Results showed that a 1.07 Lg disinfection rate can be achieved using a UV dose of 20 mJ cm(-2), while the optimal UV intensity was 0.01 mW cm(-2). Particle sizes ≥8 μm decreased the disinfection efficiency, whereas variation in particle number in activated carbon-filtered water did not significantly affect the disinfection efficiency. Photoreactivation ratio was reduced from 12.07% to 1.69% when the UV dose was increased from 5 mJ cm(-2) to 20 mJ cm(-2). Laboratory and on-site pilot-scale experiments have demonstrated that UV/TiO2 photocatalytic disinfection technology is capable of controlling the risk posed by carbon-bacteria complexes and securing drinking water safety.

Ozone disintegration of excess biomass and application to nitrogen removal.

PubMed

Park, Ki Young; Lee, Jae Woo; Ahn, Kyu-Hong; Maeng, Sung Kyu; Hwang, Jong Hyuk; Song, Kyung-Guen

2004-01-01

A pilot-scale facility integrated with an ozonation unit was built to investigate the feasibility of using ozone-disintegration byproducts of wasted biomass as a carbon source for denitrification. Ozonation of biomass resulted in mass reduction by mineralization as well as by ozone-disintegrated biosolids recycling. Approximately 50% of wasted solids were recovered as available organic matter (ozonolysate), which included nonsettleable microparticles and soluble fractions. Microparticles were observed in abundance at relatively low levels of ozone doses, while soluble fractions became dominant at higher levels of ozone doses in ozone-disintegrated organics. Batch denitrification experiments showed that the ozonolysate could be used as a carbon source with a maximum denitrification rate of 3.66 mg nitrogen (N)/g volatile suspended solids (VSS) x h. Ozonolysate was also proven to enhance total nitrogen removal efficiency in the pilot-scale treatment facility. An optimal chemical oxygen demand (COD)-to-nitrogen ratio for complete denitrification was estimated as 5.13 g COD/g N. The nitrogen-removal performance of the modified intermittently decanted extended aeration process dependent on an external carbon supply could be described as a function of solids retention time.

Successful pharmacogenetics-based optimization of unboosted atazanavir plasma exposure in HIV-positive patients: a randomized, controlled, pilot study (the REYAGEN study).

PubMed

Bonora, S; Rusconi, S; Calcagno, A; Bracchi, M; Viganò, O; Cusato, J; Lanzafame, M; Trentalange, A; Marinaro, L; Siccardi, M; D'Avolio, A; Galli, M; Di Perri, G

2015-11-01

Atazanavir without ritonavir, despite efficacy and tolerability, shows low plasma concentrations that warrant optimization. In a randomized, controlled, pilot trial, stable HIV-positive patients on atazanavir/ritonavir (with tenofovir/emtricitabine) were switched to atazanavir. In the standard-dose arm, atazanavir was administered as 400 mg once daily, while according to patients' genetics (PXR, ABCB1 and SLCO1B1), in the pharmacogenetic arm: patients with unfavourable genotypes received 200 mg of atazanavir twice daily. EudraCT number: 2009-014216-35. Eighty patients were enrolled with balanced baseline characteristics. The average atazanavir exposure was 253 ng/mL (150-542) in the pharmacogenetic arm versus 111 ng/mL (64-190) in the standard-dose arm (P < 0.001); 28 patients in the pharmacogenetic arm (75.7%) had atazanavir exposure >150 ng/mL versus 14 patients (38.9%) in the standard-dose arm (P = 0.001). Immunovirological and laboratory parameters had a favourable outcome throughout the study with non-significant differences between study arms. Atazanavir plasma exposure is higher when the schedule is chosen according to the patient's genetic profile. © The Author 2015. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Use of Fentanyl in Adolescents with Clinically Severe Obesity Undergoing Bariatric Surgery - a Pilot Study

PubMed Central

Vaughns, Janelle D.; Ziesenitz, Victoria C.; Williams, Elaine F.; Mushtaq, Alvina; Bachmann, Ricarda; Skopp, Gisela; Weiss, Johanna; Mikus, Gerd; van den Anker, Johannes N.

2018-01-01

Background The number of obese pediatric patients requiring anesthesia is rapidly increasing. Although fentanyl is a commonly used narcotic during surgery, there is no pharmacokinetic (PK) data available for optimal dosing of fentanyl in adolescents with clinically severe obesity. Materials and Methods An IRB-approved exploratory pilot study was conducted in 6 adolescents aged 14 to 19 years undergoing bariatric surgery. Mean total body weight (TBW) and mean BMI were 137.4 ± 14.3 kg, and 49.6 ± 6.4 kg/m2 (99.5th BMI percentile), respectively. Fentanyl was dosed intravenously for intraoperative analgesia based on ideal body weight per standard of care. PK blood samples were drawn over a 24 hour post-dose period. Fentanyl PK parameters were calculated by non-compartmental analysis. Results Mean fentanyl AUC0–∞ was 1.5 ± 0.5 h*ng/mL. Systemic clearance of fentanyl was 1522 ± 310 mL/min and 11.2 ± 2.6 mL/min*kg TBW. Volume of distribution was 635 ± 282 L and 4.7 ± 2.1 L/kg TBW. While absolute clearance was increased, absolute volume of distribution was comparable to previously established adult values. Conclusions These results suggest that fentanyl clearance is enhanced in adolescents with clinically severe obesity while volume of distribution is comparable to previously published studies. PMID:28238111

Physicians' accounts of frontline tensions when implementing pilot projects to improve primary care.

PubMed

Mansfield, Elizabeth; Bhattacharyya, Onil; Christian, Jennifer; Naglie, Gary; Steriopoulos, Vicky; Webster, Fiona

2018-03-19

Purpose Canada's primary care system has been described as "a culture of pilot projects" with little evidence of converting successful initiatives into funded, permanent programs or sharing project outcomes and insights across jurisdictions. Health services pilot projects are advocated as an effective strategy for identifying promising models of care and building integrated care partnerships in local settings. In the qualitative study reported here, the purpose of this paper is to investigate the strengths and challenges of this approach. Design/methodology/approach Semi-structured interviews were conducted with 34 primary care physicians who discussed their experiences as pilot project leads. Following thematic analysis methods, broad system issues were captured as well as individual project information. Findings While participants often portrayed themselves as advocates for vulnerable patients, mobilizing healthcare organizations and providers to support new models of care was discussed as challenging. Competition between local healthcare providers and initiatives could impact pilot project success. Participants also reported tensions between their clinical, project management and research roles with additional time demands and skill requirements interfering with the work of implementing and evaluating service innovations. Originality/value Study findings highlight the complexity of pilot project implementation, which encompasses physician commitment to addressing care for vulnerable populations through to the need for additional skill set requirements and the impact of local project environments. The current pilot project approach could be strengthened by including more multidisciplinary collaboration and providing infrastructure supports to enhance the design, implementation and evaluation of health services improvement initiatives.

Pilots' Attention Distributions Between Chasing a Moving Target and a Stationary Target.

PubMed

Li, Wen-Chin; Yu, Chung-San; Braithwaite, Graham; Greaves, Matthew

2016-12-01

Attention plays a central role in cognitive processing; ineffective attention may induce accidents in flight operations. The objective of the current research was to examine military pilots' attention distributions between chasing a moving target and a stationary target. In the current research, 37 mission-ready F-16 pilots participated. Subjects' eye movements were collected by a portable head-mounted eye-tracker during tactical training in a flight simulator. The scenarios of chasing a moving target (air-to-air) and a stationary target (air-to-surface) consist of three operational phases: searching, aiming, and lock-on to the targets. The findings demonstrated significant differences in pilots' percentage of fixation during the searching phase between air-to-air (M = 37.57, SD = 5.72) and air-to-surface (M = 33.54, SD = 4.68). Fixation duration can indicate pilots' sustained attention to the trajectory of a dynamic target during air combat maneuvers. Aiming at the stationary target resulted in larger pupil size (M = 27,105, SD = 6565), reflecting higher cognitive loading than aiming at the dynamic target (M = 23,864, SD = 8762). Pilots' visual behavior is not only closely related to attention distribution, but also significantly associated with task characteristics. Military pilots demonstrated various visual scan patterns for searching and aiming at different types of targets based on the research settings of a flight simulator. The findings will facilitate system designers' understanding of military pilots' cognitive processes during tactical operations. They will assist human-centered interface design to improve pilots' situational awareness. The application of an eye-tracking device integrated with a flight simulator is a feasible and cost-effective intervention to improve the efficiency and safety of tactical training.Li W-C, Yu C-S, Braithwaite G, Greaves M. Pilots' attention distributions between chasing a moving target and a stationary target. Aerosp Med Hum Perform. 2016; 87(12):989-995.

Pilot Study on the Safety and Tolerability of Extended Release Niacin for HIV-infected Patients with Hypertriglyceridemia

PubMed Central

Souza, Scott A; Walsh, Erica J; Shippey, Ford; Shikuma, Cecilia

2010-01-01

Background To determine the safety and tolerability of extended release niacin (ERN) in HIV-infected patients. Methods This was a pilot, open-label, 36 week study evaluating the safety and tolerability of ERN in HIV-infected patients with hypertriglyceridemia. Subjects with cardiovascular disease, diabetes or liver disease were excluded. Subjects with persistent elevation of triglyceride (TG) >200 after 8 weeks on American Heart Association Step One and Two Diets were started on ERN 500mg once daily, with continuation of the diet and exercise recommendations until the end of the study. ERN was increased by 500mg every 4 weeks, to a maximum of 1500mg/day, depending on subject tolerability. Safety and tolerability of ERN were assessed. Results Ten subjects enrolled received ERN. Dose titration and maintenance to 1500mg/day were achieved in all 10 subjects. No subject required dose adjustment. Mild flushing was experienced in 8 subjects. Asymptomatic hypophosphotemia was noted in 4 subjects; all resolved with oral phosphate supplementation. Median TG was reduced by 254 mg/dL (p<0.05). Non-significant changes were noted in liver enzymes, HDL, LDL, and total cholesterol. Fasting insulin and glucose levels did not change with treatment. Conclusion In this pilot study, ERN was well-tolerated and resulted in reduction of TG. Although the results of this study are promising, the study is limited in the small number of subjects. Further investigation is warranted. PMID:20533755

Occupational Ocular UV Exposure in Civilian Aircrew.

PubMed

Chorley, Adrian C; Baczynska, Katarzyna A; Benwell, Martin J; Evans, Bruce J W; Higlett, Michael P; Khazova, Marina; O'Hagan, John B

2016-01-01

Ultraviolet radiation (UVR) increases with altitude; however, there are a number of other factors which may influence ocular exposure during flight. The aim of this study was to assess ocular UVR exposure of pilots in airline and off-shore helicopter operations on different aircraft types and to compare with exposure in a typical office environment. In-flight data were captured on equipment including a CCD array spectroradiometer on five return sector European airline flights and one transatlantic flight from London Gatwick in addition to four helicopter flights from Aberdeen Dyce airport. Further data were collected in an office environment from three workstations during summer and winter months. A wide variation in ocular UVA dose was found during flights. The main factor influencing exposure was the UVR transmission of the windshield, which fell into two distinct profile types. In an aircraft with good UVA blocking properties, ocular exposure was found to be equivalent to office exposure and did not exceed international guideline limits regardless of external conditions or flight time. Most aircraft assessed had poor UVA blocking windshields which resulted in an ocular exposure to the unprotected eye in excess of international guideline limits (up to between 4.5 to 6.5 times greater during one flight). No significant UVB dose was found. Pilots should be warned of the potential high UVA exposure during flight and advised on the use of sunglasses. A windshield labeling system would allow the pilot to tailor their eye protection practices to that particular aircraft.

An error-dependent model of instrument-scanning behavior in commercial airline pilots. Ph.D. Thesis - May 1983

NASA Technical Reports Server (NTRS)

Jones, D. H.

1985-01-01

A new flexible model of pilot instrument scanning behavior is presented which assumes that the pilot uses a set of deterministic scanning patterns on the pilot's perception of error in the state of the aircraft, and the pilot's knowledge of the interactive nature of the aircraft's systems. Statistical analyses revealed that a three stage Markov process composed of the pilot's three predicted lookpoints (LP), occurring 1/30, 2/30, and 3/30 of a second prior to each LP, accurately modelled the scanning behavior of 14 commercial airline pilots while flying steep turn maneuvers in a Boeing 737 flight simulator. The modelled scanning data for each pilot were not statistically different from the observed scanning data in comparisons of mean dwell time, entropy, and entropy rate. These findings represent the first direct evidence that pilots are using deterministic scanning patterns during instrument flight. The results are interpreted as direct support for the error dependent model and suggestions are made for further research that could allow for identification of the specific scanning patterns suggested by the model.

Conflict Resolution Automation and Pilot Situation Awareness

NASA Technical Reports Server (NTRS)

Dao, Arik-Quang V.; Brandt, Summer L.; Bacon, Paige; Kraut, Josh; Nguyen, Jimmy; Minakata, Katsumi; Raza, Hamzah; Rozovski, David; Johnson, Walter W.

2010-01-01

This study compared pilot situation awareness across three traffic management concepts. The Concepts varied in terms of the allocation of traffic avoidance responsibility between the pilot on the flight deck, the air traffic controllers, and a conflict resolution automation system. In Concept 1, the flight deck was equipped with conflict resolution tools that enable them to fully handle the responsibility of weather avoidance and maintaining separation between ownship and surrounding traffic. In Concept 2, pilots were not responsible for traffic separation, but were provided tools for weather and traffic avoidance. In Concept 3, flight deck tools allowed pilots to deviate for weather, but conflict detection tools were disabled. In this concept pilots were dependent on ground based automation for conflict detection and resolution. Situation awareness of the pilots was measured using online probes. Results showed that individual situation awareness was highest in Concept 1, where the pilots were most engaged, and lowest in Concept 3, where automation was heavily used. These findings suggest that for conflict resolution tasks, situation awareness is improved when pilots remain in the decision-making loop.

Expanding Access to Injectable Contraception: Results From Pilot Introduction of Subcutaneous Depot Medroxyprogesterone Acetate (DMPA-SC) in 4 African Countries

PubMed Central

Stout, Anna; Wood, Siri; Barigye, George; Kaboré, Alain; Siddo, Daouda; Ndione, Ida

2018-01-01

PATH partnered with the United Nations Population Fund (UNFPA) and country ministries of health (MOHs) to coordinate pilot introductions of subcutaneous depot medroxyprogesterone acetate (subcutaneous DMPA or DMPA-SC, brand name Sayana Press) in Burkina Faso, Niger, Senegal, and Uganda from July 2014 through June 2016 in order to expand the range of methods available to women, particularly in remote locations. The pilot introductions aimed to answer key questions that would inform decisions about future investments in DMPA-SC and scaling up product availability and service-delivery innovations nationally. These questions included the extent to which DMPA-SC would appeal to first-time users of modern contraception, as well as adolescent girls and young women; whether DMPA-SC would add value to family planning programs or simply replace DMPA-IM or other modern methods; and the trends in injectables use when introducing DMPA-SC (or any injectable) at the community level for the first time. We implemented a multicountry monitoring system to track key indicators, including the number of doses administered by category of user (e.g., new users, by client age group) or delivery channel. Providers generally collected these data using their national programs' standard family planning registers. Data were analyzed for cumulative information and to examine trends over time using Microsoft Power Query for Excel and Tableau. Across the 4 countries, nearly half a million DMPA-SC doses were administered and approximately 135,000 first-time users of modern contraception were reached. Furthermore, 44% of the doses administered in 3 of the countries with data were to adolescent girls and young women under age 25. Switching from DMPA-IM to DMPA-SC was not widespread, ranging from 7% in Burkina Faso to 16% in Uganda. Results from these pilot introductions demonstrate that DMPA-SC has the potential to expand community-level access to injectables, maximize task-sharing strategies, and reach young women and new acceptors of family planning. Considered within the context of each country's setting, training approach, and introduction strategy, these results can help stakeholders in other countries make informed decisions about whether and how to include this contraceptive option in their family planning programs. PMID:29602866

Skin photoprotective and antiageing effects of a combination of rosemary (Rosmarinus officinalis) and grapefruit (Citrus paradisi) polyphenols

PubMed Central

Nobile, Vincenzo; Michelotti, Angela; Cestone, Enza; Caturla, Nuria; Castillo, Julián; Benavente-García, Obdulio; Pérez-Sánchez, Almudena; Micol, Vicente

2016-01-01

Background Plant polyphenols have been found to be effective in preventing ultraviolet radiation (UVR)-induced skin alterations. A dietary approach based of these compounds could be a safe and effective method to provide a continuous adjunctive photoprotection measure. In a previous study, a combination of rosemary (Rosmarinus officinalis) and grapefruit (Citrus paradisi) extracts has exhibited potential photoprotective effects both in skin cell model and in a human pilot trial. Objective We investigated the efficacy of a combination of rosemary (R. officinalis) and grapefruit (C. paradisi) in decreasing the individual susceptibility to UVR exposure (redness and lipoperoxides) and in improving skin wrinkledness and elasticity. Design A randomised, parallel group study was carried out on 90 subjects. Furthermore, a pilot, randomised, crossover study was carried out on five subjects. Female subjects having skin phototype from I to III and showing mild to moderate chrono- or photoageing clinical signs were enrolled in both studies. Skin redness (a* value of CIELab colour space) after UVB exposure to 1 minimal erythemal dose (MED) was assessed in the pilot study, while MED, lipoperoxides (malondialdehyde) skin content, wrinkle depth (image analysis), and skin elasticity (suction and elongation method) were measured in the main study. Results Treated subjects showed a decrease of the UVB- and UVA-induced skin alterations (decreased skin redness and lipoperoxides) and an improvement of skin wrinkledness and elasticity. No differences were found between the 100 and 250 mg extracts doses, indicating a plateau effect starting from 100 mg extracts dose. Some of the positive effects were noted as short as 2 weeks of product consumption. Conclusions The long-term oral intake of Nutroxsun™ can be considered to be a complementary nutrition strategy to avoid the negative effects of sun exposure. The putative mechanism for these effects is most likely to take place through the inhibition of UVR-induced reactive oxygen species and the concomitant inflammatory markers (lipoperoxides and cytokines) together with their direct action on intracellular signalling pathways. PMID:27374032

Navigator® and SmartPilot® View are helpful in guiding anesthesia and reducing anesthetic drug dosing.

PubMed

Cirillo, V; Zito Marinosci, G; De Robertis, E; Iacono, C; Romano, G M; Desantis, O; Piazza, O; Servillo, G; Tufano, R

2015-11-01

The recently introduced Navigator® (GE Healthcare, Helsinki, Finland) and SmartPilot® View (Dräger Medical, Lübeck, Germany) show the concentrations and predicted effects of combined anesthetic drugs, and should facilitate more precisely their titration. Our aim was to evaluate if Navigator® or SmartPilot® View guided anesthesia was associated with a good quality of analgesia, depth of hypnosis and may reduce anesthetic requirements. We performed a prospective non-randomized study. Sixty ASA I-II patients undergoing balanced general anesthesia for abdominal and plastic surgery were enrolled. Patients were divided in 4 groups. Group 1 (N. 15) and group 3 (N. 15) were cases in whom anesthesia was performed with standard monitoring plus the aid of Navigator® (Nav) or SmartPilot® View (SPV) display. Group 2 (N. 15) and group 4 (N. 15) were controls in whom anesthesia was performed with standard monitoring (heart rate, NIBP, SpO2, end-tidal CO2, end-expired sevoflurane concentration, train of four, Bispectral Index [Aspect Medical Systems, Natick, MA, USA] or Entropy [GE Healthcare]). Patients' vital parameters and end-expired sevoflurane concentration were recorded during anesthesia. All patients recovered uneventfully and showed hemodynamic stability. End-tidal sevoflurane concentrations values [median (min-max)], during maintenance of anesthesia, were significantly (P<0.05) lower in SPV [1.1% (0.8-1.5)] and Nav [1%(0.8-1.8)] groups compared to SPV-control group [1.5%(1-2.5)] and Nav-control group [1.5%(0.8-2)]. BIS and entropy values were respectively higher in the SPV group [53 (46-57)] compared to the control group [43 (37-51)] (P<0.05) and Nav group [53 (43-60)] compared to the control group [41 (35-51)] (P<0.05). No significant differences in Remifentanil dosing were observed in the four groups. Navigator® and SmartPilot® View may be of clinical use in monitoring adequacy of anesthesia. Both displays can optimize the administration and monitoring of anesthetic drugs during general anesthesia and may reduce the consumption of volatile anesthetic agents.

Nicotinamide riboside is uniquely and orally bioavailable in mice and humans.

PubMed

Trammell, Samuel A J; Schmidt, Mark S; Weidemann, Benjamin J; Redpath, Philip; Jaksch, Frank; Dellinger, Ryan W; Li, Zhonggang; Abel, E Dale; Migaud, Marie E; Brenner, Charles

2016-10-10

Nicotinamide riboside (NR) is in wide use as an NAD + precursor vitamin. Here we determine the time and dose-dependent effects of NR on blood NAD + metabolism in humans. We report that human blood NAD + can rise as much as 2.7-fold with a single oral dose of NR in a pilot study of one individual, and that oral NR elevates mouse hepatic NAD + with distinct and superior pharmacokinetics to those of nicotinic acid and nicotinamide. We further show that single doses of 100, 300 and 1,000 mg of NR produce dose-dependent increases in the blood NAD + metabolome in the first clinical trial of NR pharmacokinetics in humans. We also report that nicotinic acid adenine dinucleotide (NAAD), which was not thought to be en route for the conversion of NR to NAD + , is formed from NR and discover that the rise in NAAD is a highly sensitive biomarker of effective NAD + repletion.

Evaluation of bridge decks using non-destructive evaluation (NDE) at near highway speeds for effective asset management - pilot project.

DOT National Transportation Integrated Search

2016-09-29

This project piloted the findings from an initial research and development project pertaining to the detection, : quantification, and visualization of bridge deck distresses through the use of remote sensing techniques, specifically : combining optic...

Modeling Pilot Pulse Control

NASA Technical Reports Server (NTRS)

Bachelder, Edward; Hess, Ronald; Godfroy-Cooper, Martine; Aponso, Bimal

2017-01-01

In this study, behavioral models are developed that closely reproduced pulsive control response of two pilots from the experimental pool using markedly different control techniques (styles) while conducting a tracking task. An intriguing find was that the pilots appeared to: 1) produce a continuous, internally-generated stick signal that they integrated in time; 2) integrate the actual stick position; and 3) compare the two integrations to issue and cease pulse commands. This suggests that the pilots utilized kinesthetic feedback in order to perceive and integrate stick position, supporting the hypothesis that pilots can access and employ the proprioceptive inner feedback loop proposed by Hess' pilot Structural Model. The Pulse Models used in conjunction with the pilot Structural Model closely recreated the pilot data both in the frequency and time domains during closed-loop simulation. This indicates that for the range of tasks and control styles encountered, the models captured the fundamental mechanisms governing pulsive and control processes. The pilot Pulse Models give important insight for the amount of remnant (stick output uncorrelated with the forcing function) that arises from nonlinear pilot technique, and for the remaining remnant arising from different sources unrelated to tracking control (i.e. neuromuscular tremor, reallocation of cognitive resources, etc.).

Cognitive models of pilot categorization and prioritization of flight-deck information

NASA Technical Reports Server (NTRS)

Jonsson, Jon E.; Ricks, Wendell R.

1995-01-01

In the past decade, automated systems on modern commercial flight decks have increased dramatically. Pilots now regularly interact and share tasks with these systems. This interaction has led human factors research to direct more attention to the pilot's cognitive processing and mental model of the information flow occurring on the flight deck. The experiment reported herein investigated how pilots mentally represent and process information typically available during flight. Fifty-two commercial pilots participated in tasks that required them to provide similarity ratings for pairs of flight-deck information and to prioritize this information under two contextual conditions. Pilots processed the information along three cognitive dimensions. These dimensions included the flight function and the flight action that the information supported and how frequently pilots refer to the information. Pilots classified the information as aviation, navigation, communications, or systems administration information. Prioritization results indicated a high degree of consensus among pilots, while scaling results revealed two dimensions along which information is prioritized. Pilot cognitive workload for flight-deck tasks and the potential for using these findings to operationalize cognitive metrics are evaluated. Such measures may be useful additions for flight-deck human performance evaluation.

Symptom relief in Parkinson disease by safinamide: Biochemical and clinical evidence of efficacy beyond MAO-B inhibition.

PubMed

Stocchi, F; Vacca, L; Grassini, P; De Pandis, M F; Battaglia, G; Cattaneo, C; Fariello, R G

2006-10-10

In an open pilot study, doses of safinamide (100, 150, and 200 mg once a day, higher than previously tested) were administered to 13 parkinsonian patients along with a stable dose of dopamine (DA) agonist, causing a significant progressive improvement in motor performance as evaluated by the Unified Parkinson Disease Rating Scale (UPDRS) part III over an 8-week period (4.2 points; P < 0.001). In association with levodopa, the same doses of safinamide in another group of patients (N = 11) induced a significant decrease in motor fluctuations (UPDRS part IV, 2.1 points; P < 0.001), accompanied by a dose-proportional increase of the levodopa AUC, up to 77% from baseline. Because MAO-B was fully inhibited (95%) at all doses tested, we suggest that these biochemical and symptomatic dose-dependent effects must be related to additional mechanisms of action, such as inhibition of glutamate release, increased dopamine release, or inhibition of dopamine re-uptake. These hypotheses are under investigation and will pursue confirmation in controlled clinical trials.

Comparison of Cognitive Performance Tests for Promethazine Pharmacodynamics in Human Subjects

NASA Technical Reports Server (NTRS)

Vaksman, Z.; Boyd, J. L.; Wang, Z.; Putcha, L.

2005-01-01

The objective of this study is to compare cognitive function tests, Automated Neurological Assessment Metrics (ANAM) based Readiness Evaluation System (ARES(Registered TradeMark)) on a Palm Pilot and Windows based Spaceflight Cognitive Assessment Tool (WinSCAT(Registered TradeMark)) on a personal computer (PC) to assess performance effects of promethazine (PMZ) after administration to human subjects. In a randomized placebo-controlled cross-over design, subjects received 12.5, 25, and 50 mg intramuscular (IM) PMZ or a placebo and completed 14 sessions with WinSCAT(Registered TradeMark) (v. 1.26) and ARES(Registered TradeMark) (v. 1.27) consecutively for 72 h post dose. Maximum plasma concentrations (4.25, 6.25 and 13.33 ng/ml) were linear with dose and were achieved by 0.75, 8, and 24 h after dosing for the three doses, respectively. No significant differences in cognitive function after PMZ dosing were detected using WinSCAT(Registered TradeMark), however, tests from ARES(Registered TradeMark) demonstrated concentration dependent decrements in reaction time associated with PMZ dose.

Case Example of Dose Optimization Using Data From Bortezomib Dose-Finding Clinical Trials

PubMed Central

Backenroth, Daniel; Cheung, Ying Kuen Ken; Hershman, Dawn L.; Vulih, Diana; Anderson, Barry; Ivy, Percy; Minasian, Lori

2016-01-01

Purpose The current dose-finding methodology for estimating the maximum tolerated dose of investigational anticancer agents is based on the cytotoxic chemotherapy paradigm. Molecularly targeted agents (MTAs) have different toxicity profiles, which may lead to more long-lasting mild or moderate toxicities as well as to late-onset and cumulative toxicities. Several approved MTAs have been poorly tolerated during long-term administration, leading to postmarketing dose optimization studies to re-evaluate the optimal treatment dose. Using data from completed bortezomib dose-finding trials, we explore its toxicity profile, optimize its dose, and examine the appropriateness of current designs for identifying an optimal dose. Patients and Methods We classified the toxicities captured from 481 patients in 14 bortezomib dose-finding studies conducted through the National Cancer Institute Cancer Therapy Evaluation Program, computed the incidence of late-onset toxicities, and compared the incidence of dose-limiting toxicities (DLTs) among groups of patients receiving different doses of bortezomib. Results A total of 13,008 toxicities were captured: 46% of patients’ first DLTs and 88% of dose reductions or discontinuations of treatment because of toxicity were observed after the first cycle. Moreover, for the approved dose of 1.3 mg/m2, the estimated cumulative incidence of DLT was > 50%, and the estimated cumulative incidence of dose reduction or treatment discontinuation because of toxicity was nearly 40%. Conclusions When considering the entire course of treatment, the approved bortezomib dose exceeds the conventional ceiling DLT rate of 20% to 33%. Retrospective analysis of trial data provides an opportunity for dose optimization of MTAs. Future dose-finding studies of MTAs should take into account late-onset toxicities to ensure that a tolerable dose is identified for future efficacy and comparative trials. PMID:26926682

Case Example of Dose Optimization Using Data From Bortezomib Dose-Finding Clinical Trials.

PubMed

Lee, Shing M; Backenroth, Daniel; Cheung, Ying Kuen Ken; Hershman, Dawn L; Vulih, Diana; Anderson, Barry; Ivy, Percy; Minasian, Lori

2016-04-20

The current dose-finding methodology for estimating the maximum tolerated dose of investigational anticancer agents is based on the cytotoxic chemotherapy paradigm. Molecularly targeted agents (MTAs) have different toxicity profiles, which may lead to more long-lasting mild or moderate toxicities as well as to late-onset and cumulative toxicities. Several approved MTAs have been poorly tolerated during long-term administration, leading to postmarketing dose optimization studies to re-evaluate the optimal treatment dose. Using data from completed bortezomib dose-finding trials, we explore its toxicity profile, optimize its dose, and examine the appropriateness of current designs for identifying an optimal dose. We classified the toxicities captured from 481 patients in 14 bortezomib dose-finding studies conducted through the National Cancer Institute Cancer Therapy Evaluation Program, computed the incidence of late-onset toxicities, and compared the incidence of dose-limiting toxicities (DLTs) among groups of patients receiving different doses of bortezomib. A total of 13,008 toxicities were captured: 46% of patients' first DLTs and 88% of dose reductions or discontinuations of treatment because of toxicity were observed after the first cycle. Moreover, for the approved dose of 1.3 mg/m(2), the estimated cumulative incidence of DLT was > 50%, and the estimated cumulative incidence of dose reduction or treatment discontinuation because of toxicity was nearly 40%. When considering the entire course of treatment, the approved bortezomib dose exceeds the conventional ceiling DLT rate of 20% to 33%. Retrospective analysis of trial data provides an opportunity for dose optimization of MTAs. Future dose-finding studies of MTAs should take into account late-onset toxicities to ensure that a tolerable dose is identified for future efficacy and comparative trials. © 2016 by American Society of Clinical Oncology.

Effects of low-dose alcohol exposure on simulated merchant ship piloting by maritime cadets.

PubMed

Howland, J; Rohsenow, D J; Cote, J; Gomez, B; Mangione, T W; Laramie, A K

2001-03-01

The US Department of Transportation (DOT) regulates on-the-job alcohol use by operators of certain categories of commercial transport. For aircraft, trains, and commercial vessels, operators are subject to sanctions for having > or = 0.04 g% blood alcohol concentration (BAC). This study examines the effects of alcohol (between 0.04 and 0.05 g% BAC) on simulated merchant ship handling. A two-group randomized factorial design was used to compare beverage alcohol to placebo while controlling for baseline performance on a previous day. The study was conducted in the Maritime Simulation Center at Maine Maritime Academy, Castine, ME. Participants were 38 volunteer deck officer cadets in their junior or senior year, at least 21 years of age, with previous experience on a bridge simulator. Following a baseline trial on Day 1, on Day 2 participants were randomized to receive alcohol (0.6 g/kg for males and 0.5 g/kg for females) or placebo. After allowing time for absorption, participants completed a bridge simulator task. For baseline and performance trials, participants were randomized to one of four bridge simulator scenarios, each representing passage of a fully loaded container vessel through a channel with commercial traffic. The aggregate scenario score given by blinded maritime educators measured performance. A main effect for alcohol was found indicating that performance was significantly impaired by this low dose of alcohol relative to performance in the placebo condition. These findings are consistent with current federal regulations that limit low-dose alcohol exposure for the operators of commercial transport vehicles. Further research is required to determine effects at lower BACs.

Parathion alters incubation behavior of laughing gulls

USGS Publications Warehouse

White, D.H.; Mitchell, C.A.; Hill, E.F.

1983-01-01

One member of each pair of incubating laughing gulls at 9 nests was trapped, orally dosed with either 6 mg/kg parathion in corn oil or corn oil alone, and marked about the neck with red dye. Each nest was marked with a numbered stake and the treatment was recorded. A pilot study with captive laughing gulls had determined the proper dosage of parathion that would significantly inhibit their brain AChE activity (about 50% of normal) without overt signs of poisoning. After dosing, birds were released and the nests were observed for 2 1/2 days from a blind on the nesting island. The activities of the birds at each marked nest were recorded at 10-minute intervals. Results indicated that on the day of treatment there was no difference (P greater than 0.05, Chi-square test) in the proportion of time spent on the nest between treated and control birds. However, birds dosed with 6 mg/kg parathion spent significantly less time incubating on days 2 and 3 than did birds receiving only corn oil. By noon on the third day, sharing of nest duties between pair members in the treated group had approached normal, indicating recovery from parathion intoxication. These findings suggest that sublethal exposure of nesting birds to an organophosphate (OP) insecticide, such as parathion, may result in decreased nest attentiveness, thereby making the clutch more susceptible to predation or egg failure. Behavioral changes caused by sublethal OP exposure could be especially detrimental in avian species where only one pair member incubates or where both members are exposed in species sharing nest duties.

Assessing the elimination of user fees for delivery services in Laos.

PubMed

Boudreaux, Chantelle; Chanthala, Phetdara; Lindelow, Magnus

2014-01-01

A pilot eliminating user fees associated with delivery at the point of services was introduced in two districts of Laos in March 2009. Following two years of implementation, an evaluation was conducted to assess the pilot impact, as well as to document the pilot design and implementation challenges. Study results show that, even in the presence of the substantial access and cultural barriers, user fees associated with delivery at health facilities act as a serious deterrent to care seeking behavior. We find a tripling of facility-based delivery rates in the intervention areas, compared to a 40% increase in the control areas. While findings from the control region suggest that facility-based delivery rates may be on the rise across the country, the substantially higher increase in the pilot areas highlight the impact of financial burden associated with facility-based delivery fees. These fees can play an important role in rapidly increasing the uptake of facility delivery to reach the national targets and, ultimately, to improve maternal and child health outcomes. The pilot achieved important gains while relying heavily on capacity and systems already in place. However, the high cost associated with monitoring and evaluation suggest broad-scale expansion of the pilot activities is likely to necessitate targeted capacity building initiatives, especially in areas with limited district level capacity to manage funds and deliver detailed and timely reports.

The effects of visual scenes on roll and pitch thresholds in pilots versus nonpilots.

PubMed

Otakeno, Shinji; Matthews, Roger S J; Folio, Les; Previc, Fred H; Lessard, Charles S

2002-02-01

Previous studies have indicated that, compared with nonpilots, pilots rely more on vision than "seat-of-the-pants" sensations when presented with visual-vestibular conflict. The objective of this study was to evaluate whether pilots and nonpilots differ in their thresholds for tilt perception while viewing visual scenes depicting simulated flight. This study was conducted in the Advanced Spatial Disorientation Demonstrator (ASDD) at Brooks AFB, TX. There were 14 subjects (7 pilots and 7 nonpilots) who recorded tilt detection thresholds in pitch and roll while exposed to sub-threshold movement in each axis. During each test run, subjects were presented with computer-generated visual scenes depicting accelerating forward flight by day or night, and a blank (control) condition. The only significant effect detected by an analysis of variance (ANOVA) was that all subjects were more sensitive to tilt in roll than in pitch [F (2,24) = 18.96, p < 0.001]. Overall, pilots had marginally higher tilt detection thresholds compared with nonpilots (p = 0.055), but the type of visual scene had no significant effect on thresholds. In this study, pilots did not demonstrate greater visual dominance over vestibular and proprioceptive cues than nonpilots, but appeared to have higher pitch and roll thresholds overall. The finding of significantly lower detection thresholds in the roll axis vs. the pitch axis was an incidental finding for both subject groups.

Accuracy of Monte Carlo simulations compared to in-vivo MDCT dosimetry

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bostani, Maryam, E-mail: mbostani@mednet.ucla.edu; McMillan, Kyle; Cagnon, Chris H.

Purpose: The purpose of this study was to assess the accuracy of a Monte Carlo simulation-based method for estimating radiation dose from multidetector computed tomography (MDCT) by comparing simulated doses in ten patients to in-vivo dose measurements. Methods: MD Anderson Cancer Center Institutional Review Board approved the acquisition of in-vivo rectal dose measurements in a pilot study of ten patients undergoing virtual colonoscopy. The dose measurements were obtained by affixing TLD capsules to the inner lumen of rectal catheters. Voxelized patient models were generated from the MDCT images of the ten patients, and the dose to the TLD for allmore » exposures was estimated using Monte Carlo based simulations. The Monte Carlo simulation results were compared to the in-vivo dose measurements to determine accuracy. Results: The calculated mean percent difference between TLD measurements and Monte Carlo simulations was −4.9% with standard deviation of 8.7% and a range of −22.7% to 5.7%. Conclusions: The results of this study demonstrate very good agreement between simulated and measured doses in-vivo. Taken together with previous validation efforts, this work demonstrates that the Monte Carlo simulation methods can provide accurate estimates of radiation dose in patients undergoing CT examinations.« less

In vivo semiconductor dosimetry as part of routine quality assurance.

PubMed

Millwater, C J; MacLeod, A S; Thwaites, D I

1998-06-01

This paper describes the initial physics testing necessary before diodes can be used for in vivo dosimetry as well as the development of a protocol for clinical use in head and neck treatment and the preliminary results acquired. 50 patients were entered into the pilot study. A total of 300 treatment set-ups were measured (184 entrance doses and 116 exit doses). Wedged and unwedged components of each field were measured separately, making the total number of entrance doses 284 and total number of exit doses 207. There was no significant systematic deviation in the measured entrance dose compared with the expected (mean +0.4%, SD 2.7%). Discrepancies between the observed and expected entrance doses of greater than 5% were recorded in 6% (16/284) of measurements. The mean of the measured exit doses was 2.4% lower than expected (SD 4.8%). Discrepancies between the observed and expected exist doses of greater than 5% were recorded in 32% (67/207) of measurements. Possible causes for these discrepancies are discussed. Overall analysis of the data for individual patients suggest that in one patient out of the 50 there may have been a delivered target volume dose discrepancy of greater than 5% (+6.5%). The significance of the results and the implications for routine use are discussed.

Music Teachers' Everyday Conceptions of Musicality.

ERIC Educational Resources Information Center

Brandstrom, Sture

1999-01-01

Investigates music teachers' everyday conceptions of musicality through (1) a pilot study involving music teachers in higher education and (2) interviews with teachers in music teacher education and in compulsory school. Finds in the pilot the categories of musical achievement, musical experience, and musical communication, while the interviews…

ICT, Professional Learning: Towards Communities of Practice

ERIC Educational Resources Information Center

Webb, Ivan; Robertson, Margaret; Fluck, Andrew

2005-01-01

This article reports on findings from "action research" pilot projects in four Tasmanian primary schools. The projects focused on the provision of professional learning to support the use of information and communication technology (ICT) in teaching and learning. These pilot projects used an approach developed from observations of…

Burnout among pilots: psychosocial factors related to happiness and performance at simulator training.

PubMed

Demerouti, Evangelia; Veldhuis, Wouter; Coombes, Claire; Hunter, Rob

2018-06-18

In this study among airline pilots, we aim to uncover the work characteristics (job demands and resources) and the outcomes (job crafting, happiness and simulator training performance) that are related to burnout for this occupational group. Using a large sample of airline pilots, we showed that 40% of the participating pilots experience high burnout. In line with Job Demands-Resources theory, job demands were detrimental for simulator training performance because they made pilots more exhausted and less able to craft their job, whereas job resources had a favourable effect because they reduced feelings of disengagement and increased job crafting. Moreover, burnout was negatively related to pilots' happiness with life. These findings highlight the importance of psychosocial factors and health for valuable outcomes for both pilots and airlines. Practitioner Summary: Using an online survey among the members of a European pilots' professional association, we examined the relationship between psychosocial factors (work characteristics, burnout) and outcomes (simulator training performance, happiness). Forty per cent of the participating pilots experience high burnout. Job demands were detrimental, whereas job resources were favourable for simulator training performance/happiness. Twitter text: 40% of airline pilots experience burnout and psychosocial work factors and burnout relate to performance at pilots' simulator training.

Population dose near the Semipalatinsk test site.

PubMed

Hille, R; Hill, P; Bouisset, P; Calmet, D; Kluson, J; Seisebaev, A; Smagulov, S

1998-10-01

To determine the consequences of atmospheric atomic bomb tests for the population in the surroundings of the former nuclear weapons test site near Semipalatinsk in Kazakhstan, a pilot study was performed by an international cooperation between Kazakh, French, Czech and German institutions at two villages, Mostik and Maisk. Together with Kazakh scientists, eight experts from Europe carried out a field mission in September 1995 to assess, within the framework of a NATO supported project, the radiological situation as far as external doses, environmental contamination and body burden of man were concerned. A summary of the results obtained is presented. The actual radiological situation near the test site is characterized by fallout contaminations. Cs was found in upper soil layers in concentrations similar to those of the global fallout. Also Sr, Am and Co were observed. The resulting present dose to the population is low. Mean external doses from soil contamination for Maisk and Mostik (0.60-0.63 mSv/year) presently correspond to mean external doses in normal environments. Mean values of the annual internal doses observed in these two villages are below 2 microSv/year for 90Sr. For other radionuclides the internal doses are also negligible.

Numerical and flight simulator test of the flight deterioration concept

NASA Technical Reports Server (NTRS)

Mccarthy, J.; Norviel, V.

1982-01-01

Manned flight simulator response to theoretical wind shear profiles was studied in an effort to calibrate fixed-stick and pilot-in-the-loop numerical models of jet transport aircraft on approach to landing. Results of the study indicate that both fixed-stick and pilot-in-the-loop models overpredict the deleterious effects of aircraft approaches when compared to pilot performance in the manned simulator. Although the pilot-in-the-loop model does a better job than does the fixed-stick model, the study suggests that the pilot-in-the-loop model is suitable for use in meteorological predictions of adverse low-level wind shear along approach and departure courses to identify situations in which pilots may find difficulty. The model should not be used to predict the success or failure of a specific aircraft. It is suggested that the pilot model be used as part of a ground-based Doppler radar low-level wind shear detection and warning system.

Mandibular position influence on pilots' postural balance analyzed under dynamic conditions.

PubMed

Baldini, Alberto; Nota, Alessandro; Cioffi, Clementina; Ballanti, Fabiana; Tecco, Simona

2017-11-01

The aim of this study is to evaluate the influence of the mandibular position on the postural stability in a sample of civilian and military pilots. Twenty military pilots (males, mean age 35.15 ± 3.14 years) and 17 civilian pilots (males, mean 34.91 ± 2.15 years) were enrolled in this study and underwent a Sensory Organization Test (SOT) using the EquiTest® (NeuroCom International Inc., Clackamas, OR, USA) computerized dynamic posturography. The composite parameter was recorded and analyzed. The equilibrium score (ES) recorded in centric occlusion is slightly higher than the ES recorded in mandibular rest position; civilian pilots showed ESs slightly higher than military pilots. The two-way ANOVA analysis shows these differences are not statistically significant. The findings of this study seem to suggest that the composite parameter of the SOT is not sensitive in analyzing the influence of the stomatognathic system on the postural balance of civilian and military pilots.

Increased nature relatedness and decreased authoritarian political views after psilocybin for treatment-resistant depression.

PubMed

Lyons, Taylor; Carhart-Harris, Robin L

2018-01-01

Previous research suggests that classical psychedelic compounds can induce lasting changes in personality traits, attitudes and beliefs in both healthy subjects and patient populations. Here we sought to investigate the effects of psilocybin on nature relatedness and libertarian-authoritarian political perspective in patients with treatment-resistant depression (TRD). This open-label pilot study with a mixed-model design studied the effects of psilocybin on measures of nature relatedness and libertarian-authoritarian political perspective in patients with moderate to severe TRD ( n=7) versus age-matched non-treated healthy control subjects ( n=7). Psilocybin was administered in two oral dosing sessions (10 mg and 25 mg) 1 week apart. Main outcome measures were collected 1 week and 7-12 months after the second dosing session. Nature relatedness and libertarian-authoritarian political perspective were assessed using the Nature Relatedness Scale (NR-6) and Political Perspective Questionnaire (PPQ-5), respectively. Nature relatedness significantly increased ( t(6)=-4.242, p=0.003) and authoritarianism significantly decreased ( t(6)=2.120, p=0.039) for the patients 1 week after the dosing sessions. At 7-12 months post-dosing, nature relatedness remained significantly increased ( t(5)=-2.707, p=0.021) and authoritarianism remained decreased at trend level ( t(5)=-1.811, p=0.065). No differences were found on either measure for the non-treated healthy control subjects. This pilot study suggests that psilocybin with psychological support might produce lasting changes in attitudes and beliefs. Although it would be premature to infer causality from this small study, the possibility of drug-induced changes in belief systems seems sufficiently intriguing and timely to deserve further investigation.

High doses of biotin in chronic progressive multiple sclerosis: a pilot study.

PubMed

Sedel, Frédéric; Papeix, Caroline; Bellanger, Agnès; Touitou, Valérie; Lebrun-Frenay, Christine; Galanaud, Damien; Gout, Olivier; Lyon-Caen, Olivier; Tourbah, Ayman

2015-03-01

No drug has been found to have any impact on progressive multiple sclerosis (MS). Biotin is a vitamin acting as a coenzyme for carboxylases involved in key steps of energy metabolism and fatty acids synthesis. Among others, biotin activates acetylCoA carboxylase, a potentially rate-limiting enzyme in myelin synthesis. The aim of this pilot study is to assess the clinical efficacy and safety of high doses of biotin in patients suffering from progressive MS. Uncontrolled, non-blinded proof of concept study 23 consecutive patients with primary and secondary progressive MS originated from three different French MS reference centers were treated with high doses of biotin (100-300mg/day) from 2 to 36 months (mean=9.2 months). Judgement criteria varied according to clinical presentations and included quantitative and qualitative measures. In four patients with prominent visual impairment related to optic nerve injury, visual acuity improved significantly. Visual evoked potentials in two patients exhibited progressive reappearance of P100 waves, with normalization of latencies in one case. Proton magnetic resonance spectroscopy (H-MRS) in one case showed a progressive normalization of the Choline/Creatine ratio. One patient with left homonymous hemianopia kept on improving from 2 to 16 months following treatment׳s onset. Sixteen patients out of 18 (89%) with prominent spinal cord involvement were considered as improved as confirmed by blinded review of videotaped clinical examination in 9 cases. In all cases improvement was delayed from 2 to 8 months following treatment׳s onset. These preliminary data suggest that high doses of biotin might have an impact on disability and progression in progressive MS. Two double-blind placebo-controlled trials are on going. Copyright © 2015 The Authors. Published by Elsevier B.V. All rights reserved.

A diagnostic microdosing approach to investigate platinum sensitivity in non-small cell lung cancer

DOE PAGES

Wang, Si-Si; Zimmermann, Maike; Zhang, Hongyong; ...

2017-04-24

The platinum-based drugs cisplatin, carboplatin and oxaliplatin are often used for chemotherapy, but drug resistance is common. The prediction of resistance to these drugs via genomics is a challenging problem since hundreds of genes are involved. A possible alternative is to use mass spectrometry to determine the propensity for cells to form drug-DNA adducts—the pharmacodynamic drug-target complex for this class of drugs. In this paper, the feasibility of predictive diagnostic microdosing was assessed in non-small cell lung cancer (NSCLC) cell culture and a pilot clinical trial. Accelerator mass spectrometry (AMS) was used to quantify [ 14C]carboplatin-DNA monoadduct levels in themore » cell lines induced by microdoses and therapeutic doses of carboplatin, followed by correlation with carboplatin IC 50 values for each cell line. The adduct levels in cell culture experiments were linearly proportional to dose (R 2 = 0.95, p < 0.0001) and correlated with IC 50 across all cell lines for microdose and therapeutically relevant carboplatin concentrations (p = 0.02 and p = 0.01, respectively). A pilot microdosing clinical trial was conducted to define protocols and gather preliminary data. Plasma pharmacokinetics (PK) and [ 14C]carboplatin-DNA adducts in white blood cells and tumor tissues from six NSCLC patients were quantified via AMS. The blood plasma half-life of [ 14C]carboplatin administered as a microdose was consistent with the known PK of therapeutic dosing. The optimal [ 14C]carboplatin formulation for the microdose was 10 7 dpm/kg of body weight and 1% of the therapeutic dose for the total mass of carboplatin. No microdose-associated toxicity was observed in the patients. Finally, additional accruals are required to significantly correlate adduct levels with response.« less

A diagnostic microdosing approach to investigate platinum sensitivity in non-small cell lung cancer

DOE Office of Scientific and Technical Information (OSTI.GOV)

Wang, Si-Si; Zimmermann, Maike; Zhang, Hongyong

The platinum-based drugs cisplatin, carboplatin and oxaliplatin are often used for chemotherapy, but drug resistance is common. The prediction of resistance to these drugs via genomics is a challenging problem since hundreds of genes are involved. A possible alternative is to use mass spectrometry to determine the propensity for cells to form drug-DNA adducts—the pharmacodynamic drug-target complex for this class of drugs. In this paper, the feasibility of predictive diagnostic microdosing was assessed in non-small cell lung cancer (NSCLC) cell culture and a pilot clinical trial. Accelerator mass spectrometry (AMS) was used to quantify [ 14C]carboplatin-DNA monoadduct levels in themore » cell lines induced by microdoses and therapeutic doses of carboplatin, followed by correlation with carboplatin IC 50 values for each cell line. The adduct levels in cell culture experiments were linearly proportional to dose (R 2 = 0.95, p < 0.0001) and correlated with IC 50 across all cell lines for microdose and therapeutically relevant carboplatin concentrations (p = 0.02 and p = 0.01, respectively). A pilot microdosing clinical trial was conducted to define protocols and gather preliminary data. Plasma pharmacokinetics (PK) and [ 14C]carboplatin-DNA adducts in white blood cells and tumor tissues from six NSCLC patients were quantified via AMS. The blood plasma half-life of [ 14C]carboplatin administered as a microdose was consistent with the known PK of therapeutic dosing. The optimal [ 14C]carboplatin formulation for the microdose was 10 7 dpm/kg of body weight and 1% of the therapeutic dose for the total mass of carboplatin. No microdose-associated toxicity was observed in the patients. Finally, additional accruals are required to significantly correlate adduct levels with response.« less

Stereotactic body radiation therapy with concurrent full-dose gemcitabine for locally advanced pancreatic cancer: a pilot trial demonstrating safety

PubMed Central

2013-01-01

Background Concurrent chemoradiation is a standard option for locally advanced pancreatic cancer (LAPC). Concurrent conventional radiation with full-dose gemcitabine has significant toxicity. Stereotactic body radiation therapy (SBRT) may provide the opportunity to administer radiation in a shorter time frame with similar efficacy and reduced toxicity. This Pilot study assessed the safety of concurrent full-dose gemcitabine with SBRT for LAPC. Methods Patients received gemcitabine, 1000 mg/m2 for 6 cycles. During week 4 of cycle 1, patients received SBRT (25 Gy delivered in five consecutive daily fractions of 5 Gy prescribed to the 75-83% isodose line). Acute and late toxicities were assessed using NIH CTCAE v3. Tumor response was assessed by RECIST. Patients underwent an esophagogastroduodenoscopy at baseline, 2, and 6 months to assess the duodenal mucosa. Quality of life (QoL) data was collected before and after treatment using the QLQ-C30 and QLQ-PAN26 questionnaires. Results Between September 2009 and February 2011, 11 patients enrolled with one withdrawal during radiation therapy. Patients had grade 1 to 2 gastrointestinal toxicity from the start of SBRT to 2 weeks after treatment. There were no grade 3 or greater radiation-related toxicities or delays for cycle 2 of gemcitabine. On endoscopy, there were no grade 2 or higher mucosal toxicities. Two patients had a partial response. The median progression free and overall survival were 6.8 and 12.2 months, respectively. Global QoL did not change between baseline and immediately after radiation treatment. Conclusions SBRT with concurrent full dose gemcitabine is safe when administered to patients with LAPC. There is no delay in administration of radiation or chemotherapy, and radiation is completed with minimal toxicity. PMID:23452509

Weight-based enoxaparin dosing and deep vein thrombosis in hospitalized trauma patients: A double-blind, randomized, pilot study.

PubMed

Kay, Annika Bickford; Majercik, Sarah; Sorensen, Jeffrey; Woller, Scott C; Stevens, Scott M; White, Thomas W; Morris, David S; Baldwin, Margaret; Bledsoe, Joseph R

2018-04-23

Venous thromboembolism is a cause of morbidity and mortality in trauma patients. Chemoprophylaxis with low-molecular-weight heparin at a standardized dose is recommended. Conventional chemoprophylaxis may be inadequate. We hypothesized that a weight-adjusted enoxaparin prophylaxis regimen would reduce the frequency of venous thromboembolism in hospitalized trauma patients and at 90-day follow-up. This prospective, randomized pilot study enrolled adult patients admitted to a level 1 trauma center between July 2013 and January 2015. Subjects were randomized to receive either standard (30 mg subcutaneously every 12 hours) or weight-based (0.5mg/kg subcutaneously every 12 hours) enoxaparin. Surveillance duplex ultrasound for lower extremity deep vein thrombosis was performed on hospital days 1, 3, and 7, and weekly thereafter. The primary outcome was deep vein thrombosis during hospitalization. Secondary outcomes included venous thromboembolism at 90 days and significant bleeding events. Two hundred thirty-four (124 standard, 110 weight-based) subjects were enrolled. There was no difference between standard and weight-based regarding age, body mass index, percentage female gender, injury severity score, or percentage that had surgery. There was a trend toward less in-hospital deep vein thrombosis in weight-based (12 [9.7%] standard vs 4 [3.6%] weight-based, P = .075). At 90 days, there was no difference in venous thromboembolism (12 [9.7%] standard vs 6 [5.5%] weight-based, P =.34). There was 1 bleeding event, which occurred in a standard subject. Weight-based enoxaparin dosing for venous thromboembolism chemoprophylaxis in trauma patients may provide better protection against venous thromboembolism than standard. A definitive study is necessary to determine whether weight-based dosing is superior to standard. Copyright © 2018 Elsevier Inc. All rights reserved.

A comparative pilot study of second-generation antipsychotics in children and adolescents with schizophrenia-spectrum disorders.

PubMed

Jensen, Jonathan B; Kumra, Sanjiv; Leitten, Willa; Oberstar, Joel; Anjum, Afshan; White, Tonya; Wozniak, Jeffrey; Lee, Susanne S; Schulz, S Charles

2008-08-01

There is a limited evidence base to guide treatment of children and adolescents with nonaffective psychoses because few comparative studies of first-line second-generation antipsychotics (SGAs) have been undertaken. To plan the design of a subsequent randomized controlled trial (RCT), the authors conducted this pilot study to demonstrate the feasibility of the treatment and measurement protocols. Thirty children and adolescents (20 males, 10 females), ages 10-18 years, who met unmodified Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for a schizophrenia-spectrum disorder (schizophrenia, schizoaffective, schizophreniform, psychotic disorder not otherwise specified) were randomized to receive 12 weeks of open-label, flexibly dosed treatment with either risperidone (mean [standard deviation, SD] dose = 3.4 mg [1.5]), olanzapine (mean [SD] dose = 14.0 mg [4.6]) or quetiapine (mean [SD] dose = 611 mg [253.4]). Twenty one (70%) of 30 subjects completed the study. There was no overall statistically significant difference with regard to reduction in Positive and Negative Syndrome Scale (PANSS) total scores in treatment efficacy observed (F((2,24)) = 3.13, p = 0.06). However, the possibility of a large differential treatment effect with regard to change in PANSS total scores favoring risperidone relative to quetiapine (risperidone vs. quetiapine, d = 1.10 [95% confidence interval, CI, 0.09-2.01]) was suggested by the point estimate. These preliminary data, viewed together with the extant literature, suggest that a future larger RCT with only two treatment arms may be warranted to establish whether there is a clinically significant differential treatment effect between risperidone and quetiapine for children and adolescents with nonaffective psychoses. Additional challenges and considerations for mounting a larger RCT are explored.

Exeresis and Brachytherapy as Salvage Treatment for Local Recurrence After Conservative Treatment for Breast Cancer: Results of a Ten-Year Pilot Study

DOE Office of Scientific and Technical Information (OSTI.GOV)

Guix, Benjamin, E-mail: bguix@imor.or; Lejarcegui, Jose Antonio; Tello, Jose Ignacio

2010-11-01

Purpose: To analyze the long-term results of a pilot study assessing excision and brachytherapy as salvage treatment for local recurrence after conservative treatment of breast cancer. Methods and Materials: Between December 1990 and March 2001, 36 patients with breast-only recurrence less than 3 cm in diameter after conservative treatment for Stage I or II breast carcinoma were treated with local excision followed by high-dose rate brachytherapy implants (30 Gy in 12 fractions over a period of 5 days). No patient was lost to follow-up. Special attention was paid to local, regional, or distant recurrences; survival; cosmesis; and early and latemore » side effects. Results: All patients completed treatment. During follow-up (range, 1-13 years), 8 patients presented metastases (2 regional and 6 distant) as their first site of failure, 1 had a differed local recurrence, and 1 died of the disease. Actuarial results at 10 years were as follows: local control, 89.4%; disease-free survival, 64.4%; and survival, 96.7%. Cosmetic results were satisfactory in 90.4%. No patient had Grade 3 or 4 early or late complications. Of the 11 patients followed up for at least 10 years, all but 1 still had their breast in place at the 10-year stage. Conclusions: High-dose rate brachytherapy is a safe, effective treatment for small-size, low-risk local recurrence after local excision in conservatively treated patients. The dose of 30 Gy of high-dose rate brachytherapy (12 fractions over a period of 5 days twice daily) was well tolerated. The excellent results support the use of breast preservation as salvage treatment in selected patients with local recurrence after conservative treatment for breast cancer.« less

Impact of Bromocriptine-QR Therapy on Glycemic Control and Daily Insulin Requirement in Type 2 Diabetes Mellitus Subjects Whose Dysglycemia Is Poorly Controlled on High-Dose Insulin: A Pilot Study

PubMed Central

Roe, Erin D.; Chamarthi, Bindu; Raskin, Philip

2015-01-01

Background. The concurrent use of a postprandial insulin sensitizing agent, such as bromocriptine-QR, a quick release formulation of bromocriptine, a dopamine D2 receptor agonist, may offer a strategy to improve glycemic control and limit/reduce insulin requirement in type 2 diabetes (T2DM) patients on high-dose insulin. This open label pilot study evaluated this potential utility of bromocriptine-QR. Methods. Ten T2DM subjects on metformin (1-2 gm/day) and high-dose (TDID ≥ 65 U/day) basal-bolus insulin were enrolled to receive once daily (morning) bromocriptine-QR (1.6–4.8 mg/day) for 24 weeks. Subjects with at least one postbaseline HbA1c measurement (N = 8) were analyzed for change from baseline HbA1c, TDID, and postprandial glucose area under the curve of a four-hour mixed meal tolerance test (MMTT). Results. Compared to the baseline, average HbA1c decreased 1.76% (9.74 ± 0.56 to 7.98 ± 0.36, P = 0.01), average TDID decreased 27% (199 ± 33 to 147 ± 31, P = 0.009), and MMTT AUC60–240 decreased 32% (P = 0.04) over the treatment period. The decline in HbA1c and TDID was observed at 8 weeks and sustained over the remaining 16-week study duration. Conclusion. In this study, bromocriptine-QR therapy improved glycemic control and meal tolerance while reducing insulin requirement in T2DM subjects poorly controlled on high-dose insulin therapy. PMID:26060825

A Pilot Analysis of the Association Between Types of Monitored Anesthesia Care Drugs and Outcomes in Transfemoral Aortic Valve Replacement Performed Without General Anesthesia.

PubMed

Chen, Eric Y; Sukumar, Nitin; Dai, Feng; Akhtar, Shamsuddin; Schonberger, Robert B

2018-04-01

The types of agents used for monitored anesthesia care (MAC) and their possible differential effects on outcomes have received less study despite increased use over general anesthesia (GA) in transfemoral aortic valve replacements (TAVRs). In this pilot analysis of patients undergoing TAVR using MAC, the authors described the anesthetic agents used and sought to investigate the possible association of anesthetic agent choice with outcomes and the extent to which total weight and time-adjusted doses of anesthetics declined with increasing 10-year age increments. Retrospective observational study. Tertiary teaching hospital. Ninety-three participants scheduled to undergo TAVR, with a primary plan of conscious sedation between November 2014 and June 2016, were included. None. Types of MAC were divided into 4 primary groups, but 2 groups were focused: propofol (n = 39) and dexmedetomidine plus propofol (n = 34). Conversion to GA occurred in 6 participants (6.45%) and was not associated with the type of sedation received. The authors also compared patients who received dexmedetomidine with those who did not in accordance with their a priori analytic plan. There were no associations between the use of dexmedetomidine and postoperative delirium or intensive care unit/hospital length of stay. No significant trends in medication dose adjustments were seen across increasing 10-year age increments. A wide breadth of MAC medications is in use among TAVR patients and does not support differences in outcomes. Despite recommendations to reduce anesthetic drug dosing in the elderly, no significant trends in dose reduction with increasing age were noted. Copyright © 2017 Elsevier Inc. All rights reserved.

Effects of hydration on cognitive function of pilots.

PubMed

Lindseth, Paul D; Lindseth, Glenda N; Petros, Thomas V; Jensen, Warren C; Caspers, Julie

2013-07-01

The objective of this study was to examine the effect of fluid intake and possible dehydration on cognitive flight performance of pilots. A repeated-measures, counterbalanced, mixed study design was used to examine differences in working memory, spatial orientation, and cognitive flight performance of 40 randomly selected healthy pilots after having high and low fluid intakes. Serial weights were also analyzed to determine differences in cognitive flight performance of the dehydrated (1-3% weight loss) and hydrated study participants. Results showed flight performance and spatial cognition test scores were significantly (p < 0.05) poorer for pilots who had low fluid intakes and experienced dehydration in comparison to the hydrated pilots. These findings indicate fluid intake differences resulting in dehydration may have safety implications because peak cognitive performance among pilots is critical for flight safety. Reprint & Copyright © 2013 Association of Military Surgeons of the U.S.

UPPER MISSOURI RIVER ENVIRONMENTAL MONITORING AND ASSESSMENT PROGRAM (EMAP-UMR): 2000 PILOT STUDY FINDINGS AND FURTHER DIRECTION

EPA Science Inventory

The EPA Office of Research and Development's Mid-Continent Ecology Division has undertaken an EMAP study to assess the condition of selected resources of the Upper Missouri River mainstem (riverine) aquatic habitats, riparian habitats, and reservoirs. In 2000, we completed pilot ...

Dementia and Depression in Elders with Mental Retardation: A Pilot Study.

ERIC Educational Resources Information Center

Harper, Dennis C.; Wadsworth, John S.

1990-01-01

This article investigates cognitive decline and depressive symptomatology among older adults with mental retardation. A pilot study of assessment instruments is reported. Findings reveal that decreasing cognitive ability is associated with higher rates of observed depression and reported behavioral problems. Cognitive decline was associated with…

Status of Women at ESO: a Pilot Study on ESO Staff Gender Distribution

NASA Astrophysics Data System (ADS)

Primas, F.

2007-06-01

Equal career opportunities require working conditions that make it possible to reconcile family needs and career development. This article describes the goals and main findings of a pilot investigation that has recently been ­carried out at ESO focusing on gender balance issues.

Human Factors Affecting Pilot Performance in Vertical and Translational Instrument Flight

DTIC Science & Technology

1981-12-01

Creelman , 1955) involving rudimentary visual simulators that provided the student pilot not much more than a crude dynamic perspective view of the runwey he...to find a better terminal procedure. Creelman , J. A. Evaluation of approach training procedures. Pensacola, FL: U.S. Naval School of Aviation Medicine

The intersection of urban form and mileage fees : findings from the Oregon road user fee pilot program

DOT National Transportation Integrated Search

2011-03-01

This report analyzes data from the 2006-2007 Oregon Road User Fee Pilot Program to assess if and how urban form variables correlate with travel behavior changes that participants made in response to the mileage fee program. The study tested the impac...

The Internet as a Source of Academic Research Information: Findings of Two Pilot Studies.

ERIC Educational Resources Information Center

Kibirige, Harry M.; DePalo, Lisa

2000-01-01

Discussion of information available on the Internet focuses on two pilot studies that investigated how academic users perceive search engines and subject-oriented databases as sources of topical information. Highlights include information seeking behavior of academic users; undergraduate users; graduate users; faculty; and implications for…

Estimated radiation exposure of German commercial airline cabin crew in the years 1960-2003 modeled using dose registry data for 2004-2015.

PubMed

Wollschläger, Daniel; Hammer, Gaël Paul; Schafft, Thomas; Dreger, Steffen; Blettner, Maria; Zeeb, Hajo

2018-05-01

Exposure to ionizing radiation of cosmic origin is an occupational risk factor in commercial aircrew. In a historic cohort of 26,774 German aircrew, radiation exposure was previously estimated only for cockpit crew using a job-exposure matrix (JEM). Here, a new method for retrospectively estimating cabin crew dose is developed. The German Federal Radiation Registry (SSR) documents individual monthly effective doses for all aircrew. SSR-provided doses on 12,941 aircrew from 2004 to 2015 were used to model cabin crew dose as a function of age, sex, job category, solar activity, and male pilots' dose; the mean annual effective dose was 2.25 mSv (range 0.01-6.39 mSv). In addition to an inverse association with solar activity, exposure followed age- and sex-dependent patterns related to individual career development and life phases. JEM-derived annual cockpit crew doses agreed with SSR-provided doses for 2004 (correlation 0.90, 0.40 mSv root mean squared error), while the estimated average annual effective dose for cabin crew had a prediction error of 0.16 mSv, equaling 7.2% of average annual dose. Past average annual cabin crew dose can be modeled by exploiting systematic external influences as well as individual behavioral determinants of radiation exposure, thereby enabling future dose-response analyses of the full aircrew cohort including measurement error information.

Classification and prediction of pilot weather encounters: A discriminant function analysis.

PubMed

O'Hare, David; Hunter, David R; Martinussen, Monica; Wiggins, Mark

2011-05-01

Flight into adverse weather continues to be a significant hazard for General Aviation (GA) pilots. Weather-related crashes have a significantly higher fatality rate than other GA crashes. Previous research has identified lack of situational awareness, risk perception, and risk tolerance as possible explanations for why pilots would continue into adverse weather. However, very little is known about the nature of these encounters or the differences between pilots who avoid adverse weather and those who do not. Visitors to a web site described an experience with adverse weather and completed a range of measures of personal characteristics. The resulting data from 364 pilots were carefully screened and subject to a discriminant function analysis. Two significant functions were found. The first, accounting for 69% of the variance, reflected measures of risk awareness and pilot judgment while the second differentiated pilots in terms of their experience levels. The variables measured in this study enabled us to correctly discriminate between the three groups of pilots considerably better (53% correct classifications) than would have been possible by chance (33% correct classifications). The implications of these findings for targeting safety interventions are discussed.

Home Cervical Traction to Reduce Neck Pain in Fighter Pilots.

PubMed

Chumbley, Eric M; O'Hair, Nicole; Stolfi, Adrienne; Lienesch, Christopher; McEachen, James C; Wright, Bruce A

2016-12-01

Most fighter pilots report cervical pain during their careers. Recommendations for remediation lack evidence. We sought to determine whether regular use of a home cervical traction device could decrease reported cervical pain in F-15C pilots. An institutional review board-approved, Health Insurance Portability and Accountability Act-compliant, controlled crossover study was undertaken with 21 male F-15C fighter pilots between February and June 2015. Of the 21 subjects, 12 completed 6 wk each of traction and control, while logging morning, postflying, and post-traction pain. Pain was compared with paired t-tests between the periods, from initial pain scores to postflying, and postflying to post-traction. In the traction phase, initial pain levels increased postflight, from 1.2 (0.7) to 1.6 (1.0) Subsequent post-traction pain levels decreased to 1.3 (0.9), with a corresponding linear decrease in pain relative to pain reported postflight. The difference in pain levels after traction compared to initial levels was not significant, indicating that cervical traction was effective in alleviating flying-related pain. Control pain increased postflight from 1.4 (0.9) to 1.9 (1.3). Daily traction phase pain was lower than the control, but insignificant. To our knowledge, this is the first study of home cervical traction to address fighter pilots' cervical pain. We found a small but meaningful improvement in daily pain rating when using cervical traction after flying. These results help inform countermeasure development for pilots flying high-performance aircraft. Further study should clarify the optimal traction dose and timing in relation to flying.Chumbley EM, O'Hair N, Stolfi A, Lienesch C, McEachen JC, Wright BA. Home cervical traction to reduce neck pain in fighter pilots. Aerosp Med Hum Perform. 2016; 87(12):1010-1015.

Bolus intrathecal injection of ziconotide (Prialt®) to evaluate the option of continuous administration via an implanted intrathecal drug delivery (ITDD) system: a pilot study.

PubMed

Mohammed, Salma I; Eldabe, Sam; Simpson, Karen H; Brookes, Morag; Madzinga, Grace; Gulve, Ashish; Baranidharan, Ganesan; Radford, Helen; Crowther, Tracey; Buchser, Eric; Perruchoud, Christophe; Batterham, Alan Mark

2013-01-01

This study evaluated efficacy and safety of bolus doses of ziconotide (Prialt®, Eisai Limited, Hertfordshire, UK) to assess the option of continuous administration of this drug via an implanted intrathecal drug delivery system. Twenty adults with severe chronic pain who were under consideration for intrathecal (IT) therapy were enrolled in this open label, nonrandomized, pilot study. Informed consent was obtained. Demographics, medical/pain history, pain scores, and concomitant medications were recorded. A physical examination was performed. Creatine kinase was measured. Initial visual analog scale (VAS), blood pressure, heart rate, and respiratory rate were recorded. All patients received an initial bolus dose of 2.5 mcg ziconotide; the dose in the subsequent visits was modified according to response. Subsequent doses were 2.5 mcg, 1.2 mcg, or 3.75 mcg as per protocol. A good response (≥30% reduction in baseline pain VAS) with no side-effects on two occasions was considered a successful trial. Data were analyzed using a generalized estimating equations model, with pain VAS as the outcome and time (seven time points; preinjection and one to six hours postinjection) as the predictor. Generalized estimating equations analysis of summary measures showed a mean reduction of pain VAS of approximately 25% at the group level; of 11 responders, seven underwent pump implantation procedure, two withdrew because of adverse effects, one refused an implant, and one could not have an implant (lack of funding from the Primary Care Trust). Our data demonstrated that mean VAS was reduced by approximately 25% at the group level after IT ziconotide bolus. Treatment efficacy did not vary with sex, center, age, or pain etiology. Ziconotide bolus was generally well tolerated. Larger studies are needed to determine if bolus dosing with ziconotide is a good predictor of response to continuous IT ziconotide via an intrathecal drug delivery system. © 2012 International Neuromodulation Society.

Implementation of protocolized tight control and biological dose optimization in daily clinical practice: results of a pilot study.

PubMed

Lesuis, N; Verhoef, L M; Nieboer, L M; Bruyn, G A; Baudoin, P; van Vollenhoven, R F; Hulscher, Mejl; van den Hoogen, Fhj; den Broeder, A A

2017-03-01

To assess the effects of education, guideline development, and individualized treatment advice on rheumatologist adherence to tight control-based treatment and biological dose optimization in rheumatoid arthritis (RA), psoriatic arthritis (PsA), and spondyloarthropathy (SpA) patients. This pilot study, among two rheumatologists and two specialized nurses in a general hospital, combined education, feedback, local guideline development, and individualized treatment advice. Outcomes (baseline and 1 year post-intervention) were the percentage of patients with a Disease Activity Score in 28 joints (DAS28) or Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) measured during the visit, mean DAS28/BASDAI, and the percentage of patients using a reduced biological dose. DAS28 outcomes only applied to RA and PsA patients, BASDAI outcomes only applied to SpA patients whereas outcomes on biological dose applied to all patients. A total of 232 patients (67% RA, 15% PsA, 18% SpA; 58% female, mean age 56 ± 15 years) were included in the study. The percentage of DAS28 and BASDAI measurements performed increased after the intervention [DAS28 15-51%, odds ratio (OR) 3.3, 95% confidence interval (CI) 2.1-5.5; BASDAI 23-50%, OR 2.2, 95% CI 1.0-5.5], with mean DAS28 and BASDAI scores remaining similar (DAS28: mean difference 0.1, 95% CI -0.3 to 0.5; BASDAI: mean difference 0.03, 95% CI -1.8 to 1.9). Use of a reduced biological dose increased from 10% to 61% (OR 3.9, 95% CI 2.4-6.5). A multicomponent intervention strategy aimed at rheumatologists can lead to improved adherence to tight control-based treatment and a reduction in the use of biologicals in RA, SpA, and PsA patients.

Dose Titration Algorithm Tuning (DTAT) should supersede 'the' Maximum Tolerated Dose (MTD) in oncology dose-finding trials.

PubMed

Norris, David C

2017-01-01

Background . Absent adaptive, individualized dose-finding in early-phase oncology trials, subsequent 'confirmatory' Phase III trials risk suboptimal dosing, with resulting loss of statistical power and reduced probability of technical success for the investigational therapy. While progress has been made toward explicitly adaptive dose-finding and quantitative modeling of dose-response relationships, most such work continues to be organized around a concept of 'the' maximum tolerated dose (MTD). The purpose of this paper is to demonstrate concretely how the aim of early-phase trials might be conceived, not as 'dose-finding', but as dose titration algorithm (DTA) -finding. Methods. A Phase I dosing study is simulated, for a notional cytotoxic chemotherapy drug, with neutropenia constituting the critical dose-limiting toxicity. The drug's population pharmacokinetics and myelosuppression dynamics are simulated using published parameter estimates for docetaxel. The amenability of this model to linearization is explored empirically. The properties of a simple DTA targeting neutrophil nadir of 500 cells/mm 3 using a Newton-Raphson heuristic are explored through simulation in 25 simulated study subjects. Results. Individual-level myelosuppression dynamics in the simulation model approximately linearize under simple transformations of neutrophil concentration and drug dose. The simulated dose titration exhibits largely satisfactory convergence, with great variance in individualized optimal dosing. Some titration courses exhibit overshooting. Conclusions. The large inter-individual variability in simulated optimal dosing underscores the need to replace 'the' MTD with an individualized concept of MTD i . To illustrate this principle, the simplest possible DTA capable of realizing such a concept is demonstrated. Qualitative phenomena observed in this demonstration support discussion of the notion of tuning such algorithms. Although here illustrated specifically in relation to cytotoxic chemotherapy, the DTAT principle appears similarly applicable to Phase I studies of cancer immunotherapy and molecularly targeted agents.

Pilot study of erlotinib in patients with acute myeloid leukemia.

PubMed

Sayar, Hamid; Czader, Magdalena; Amin, Chirag; Cangany, Mary; Konig, Heiko; Cripe, Larry D

2015-02-01

We conducted a pilot study to investigate clinical efficacy of tyrosine kinase inhibitor erlotinib in the treatment of acute myeloid leukemia (AML). A total of 11 patients with de novo AML were treated, including 2 with relapsed and/or refractory disease and 9 older patients with previously untreated AML. Patients with high baseline leukocyte count were excluded. Erlotinib was given orally at 150 mg per day continuously in 28-day cycles. The treatment was tolerated well, and no toxicities were observed. An initial reduction in circulating blasts, followed by disease progression, was observed in 2 patients. Nine other patients did not demonstrate any response in blood or bone marrow. Baseline and post-cycle 1 flow-cytometry were performed on bone marrow blasts to investigate signs of differentiation. No immunophenotypic changes suggestive of differentiation were observed. This pilot study did not demonstrate response to standard doses of erlotinib in patients with AML. Copyright © 2014 Elsevier Ltd. All rights reserved.

Pilot age and expertise predict flight simulator performance: a 3-year longitudinal study.

PubMed

Taylor, Joy L; Kennedy, Quinn; Noda, Art; Yesavage, Jerome A

2007-02-27

Expert knowledge may compensate for age-related declines in basic cognitive and sensory-motor abilities in some skill domains. We investigated the influence of age and aviation expertise (indexed by Federal Aviation Administration pilot ratings) on longitudinal flight simulator performance. Over a 3-year period, 118 general aviation pilots aged 40 to 69 years were tested annually, in which their flight performance was scored in terms of 1) executing air-traffic controller communications; 2) traffic avoidance; 3) scanning cockpit instruments; 4) executing an approach to landing; and 5) a flight summary score. More expert pilots had better flight summary scores at baseline and showed less decline over time. Secondary analyses revealed that expertise effects were most evident in the accuracy of executing aviation communications, the measure on which performance declined most sharply over time. Regarding age, even though older pilots initially performed worse than younger pilots, over time older pilots showed less decline in flight summary scores than younger pilots. Secondary analyses revealed that the oldest pilots did well over time because their traffic avoidance performance improved more vs younger pilots. These longitudinal findings support previous cross-sectional studies in aviation as well as non-aviation domains, which demonstrated the advantageous effect of prior experience and specialized expertise on older adults' skilled cognitive performances.

Pilot age and expertise predict flight simulator performance

PubMed Central

Kennedy, Quinn; Noda, Art; Yesavage, Jerome A.

2010-01-01

Background Expert knowledge may compensate for age-related declines in basic cognitive and sensory-motor abilities in some skill domains. We investigated the influence of age and aviation expertise (indexed by Federal Aviation Administration pilot ratings) on longitudinal flight simulator performance. Methods Over a 3-year period, 118 general aviation pilots aged 40 to 69 years were tested annually, in which their flight performance was scored in terms of 1) executing air-traffic controller communications; 2) traffic avoidance; 3) scanning cockpit instruments; 4) executing an approach to landing; and 5) a flight summary score. Results More expert pilots had better flight summary scores at baseline and showed less decline over time. Secondary analyses revealed that expertise effects were most evident in the accuracy of executing aviation communications, the measure on which performance declined most sharply over time. Regarding age, even though older pilots initially performed worse than younger pilots, over time older pilots showed less decline in flight summary scores than younger pilots. Secondary analyses revealed that the oldest pilots did well over time because their traffic avoidance performance improved more vs younger pilots. Conclusions These longitudinal findings support previous cross-sectional studies in aviation as well as non-aviation domains, which demonstrated the advantageous effect of prior experience and specialized expertise on older adults’ skilled cognitive performances. PMID:17325270

Radiation exposure of German aircraft crews under the impact of solar cycle 23 and airline business factors.

PubMed

Frasch, Gerhard; Kammerer, Lothar; Karofsky, Ralf; Schlosser, Andrea; Stegemann, Ralf

2014-12-01

The exposure of German aircraft crews to cosmic radiation varies both with solar activity and operational factors of airline business. Data come from the German central dose registry and cover monthly exposures of up to 37,000 German aircraft crewmembers that were under official monitoring. During the years 2004 to 2009 of solar cycle 23 (i.e., in the decreasing phase of solar activity), the annual doses of German aircraft crews increased by an average of 20%. Decreasing solar activity allows more galactic radiation to reach the atmosphere, increasing high-altitude doses. The rise results mainly from the less effective protection from the solar wind but also from airline business factors. Both cockpit and cabin personnel differ in age-dependent professional and social status. This status determines substantially the annual effective dose: younger cabin personnel and the elder pilots generally receive higher annual doses than their counterparts. They also receive larger increases in their annual dose when the solar activity decreases. The doses under this combined influence of solar activity and airline business factors result in a maximum of exposure for German aircrews for this solar cycle. With the increasing solar activity of the current solar cycle 24, the doses are expected to decrease again.

Description and pilot results from a novel method for evaluating return of incidental findings from next-generation sequencing technologies.

PubMed

Goddard, Katrina A B; Whitlock, Evelyn P; Berg, Jonathan S; Williams, Marc S; Webber, Elizabeth M; Webster, Jennifer A; Lin, Jennifer S; Schrader, Kasmintan A; Campos-Outcalt, Doug; Offit, Kenneth; Feigelson, Heather Spencer; Hollombe, Celine

2013-09-01

The aim of this study was to develop, operationalize, and pilot test a transparent, reproducible, and evidence-informed method to determine when to report incidental findings from next-generation sequencing technologies. Using evidence-based principles, we proposed a three-stage process. Stage I "rules out" incidental findings below a minimal threshold of evidence and is evaluated using inter-rater agreement and comparison with an expert-based approach. Stage II documents criteria for clinical actionability using a standardized approach to allow experts to consistently consider and recommend whether results should be routinely reported (stage III). We used expert opinion to determine the face validity of stages II and III using three case studies. We evaluated the time and effort for stages I and II. For stage I, we assessed 99 conditions and found high inter-rater agreement (89%), and strong agreement with a separate expert-based method. Case studies for familial adenomatous polyposis, hereditary hemochromatosis, and α1-antitrypsin deficiency were all recommended for routine reporting as incidental findings. The method requires <3 days per topic. We establish an operational definition of clinically actionable incidental findings and provide documentation and pilot testing of a feasible method that is scalable to the whole genome.

Primary and booster vaccination with an inactivated poliovirus vaccine (IPV) is immunogenic and well-tolerated in infants and toddlers in China.

PubMed

Li, Rongcheng; Li, Chang Gui; Li, Yanping; Liu, Youping; Zhao, Hong; Chen, Xiaoling; Kuriyakose, Sherine; Van Der Meeren, Olivier; Hardt, Karin; Hezareh, Marjan; Roy-Ghanta, Sumita

2016-03-14

Replacing live-attenuated oral poliovirus vaccines (OPV) with inactivated poliovirus vaccines (IPV) is part of the global strategy to eradicate poliomyelitis. China was declared polio-free in 2000 but continues to record cases of vaccine-associated-poliomyelitis and vaccine-derived-poliovirus outbreaks. Two pilot safety studies and two larger immunogenicity trials evaluated the non-inferiority of IPV (Poliorix™, GSK Vaccines, Belgium) versus OPV in infants and booster vaccination in toddlers primed with either IPV or OPV in China. In pilot safety studies, 25 infants received 3-dose IPV primary vaccination (Study A, www.clinicaltrial.gov NCT00937404) and 25 received an IPV booster after priming with three OPV doses (Study B, NCT01021293). In the randomised, controlled immunogenicity and safety trial (Study C, NCT00920439), infants received 3-dose primary vaccination with IPV (N=541) or OPV (N=535) at 2,3,4 months of age, and a booster IPV dose at 18-24 months (N=470, Study D, NCT01323647: extension of study C). Blood samples were collected before and one month post-dose-3 and booster. Reactogenicity was assessed using diary cards. Serious adverse events (SAEs) were captured throughout each study. Study A and B showed that IPV priming and IPV boosting (after OPV) was safe. Study C: One month post-dose-3, all IPV and ≥ 98.3% OPV recipients had seroprotective antibody titres towards each poliovirus type. The immune response elicited by IPV was non-inferior to Chinese OPV. Seroprotective antibody titres persisted in ≥ 94.7% IPV and ≥ 96.1% OPV recipients at 18-24 months (Study D). IPV had a clinically acceptable safety profile in all studies. Grade 3 local and systemic reactions were uncommon. No SAEs were related to IPV administration. Trivalent IPV is non-inferior to OPV in terms of seroprotection (in the Chinese vaccination schedule) in infant and toddlers, with a clinically acceptable safety profile. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Memantine shows promise in reducing gambling severity and cognitive inflexibility in pathological gambling: a pilot study

PubMed Central

Chamberlain, Samuel R.; Odlaug, Brian L.; Potenza, Marc N.; Kim, Suck Won

2012-01-01

Rationale Although pathological gambling (PG) is relatively common, pharmacotherapy research for PG is limited. Memantine, an N-methyl d-aspartate receptor antagonist, appears to reduce glutamate excitability and improve impulsive decision making, suggesting it may help individuals with PG. Objective This study sought to examine the safety and efficacy of Memantine in PG. Methods Twenty-nine subjects (18 females) with DSM-IV PG were enrolled in a 10-week open-label treatment study of memantine (dose ranging from 10 to 30 mg/day). Subjects were enrolled from January 2009 until April 2010. Change from baseline to study endpoint on the Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS) was the primary outcome measure. Subjects underwent pre- and post-treatment cognitive assessments using the stop-signal task (assessing response impulsivity) and the intra-dimensional/extra-dimensional (ID/ED) set shift task (assessing cognitive flexibility). Results Twenty-eight of the 29 subjects (96.6%) completed the 10-week study. PG-YBOCS scores decreased from a mean of 21.8±4.3 at baseline to 8.9±7.1 at study endpoint (p<0.001). Hours spent gambling per week and money spent gambling both decreased significantly (p<0.001). Subjects also demonstrated a significant improvement in ID/ED total errors (p=0.037) at study endpoint. The mean effective dose of memantine was 23.4±8.1 mg/day. The medication was well-tolerated. Memantine treatment was associated with diminished gambling and improved cognitive flexibility. Conclusions These findings suggest that pharmacological manipulation of the glutamate system may target both gambling and cognitive deficits in PG. Placebo-controlled, double-blind studies are warranted in order to confirm these preliminary findings in a controlled design. PMID:20721537

A Pilot Study of the Usefulness of a Single Olanzapine Plasma Concentration as an Indicator of Early Drug Effect in a Small Sample of First-Episode Psychosis Patients

PubMed Central

Zabala, Arantzazu; Bustillo, Mariana; Querejeta, Imanol; Alonso, Marta; Mentxaka, Oiane; González-Pinto, Ana; Ugarte, Amaia; Meana, J. Javier; Gutiérrez, Miguel; Segarra, Rafael

2017-01-01

Abstract Purpose/Background Studies analyzing concentration-effect relationships in second-generation antipsychotics have reported contradictory results in chronic schizophrenia. No data are available for the early stages of the disease. The present study aims to evaluate the association between a single olanzapine plasma concentration, clinical response, and severity of adverse effects in first-episode psychosis (FEP); to test the utility of various plasma breakpoints as markers of early response to treatment; and to identify variables affecting olanzapine concentrations. Methods Data from 23 compliant FEP patients receiving olanzapine monotherapy (5–30 mg/d) were evaluated 2 months after beginning treatment. Clinical symptoms were assessed using the Positive and Negative Syndrome Scale and the Montgomery-Åsberg Depression Rating Scale. Adverse effects were rated using the Udvalg for Kliniske Undersøgelser scale. Plasma samples were drawn at 11 (SD, 1) hours after dosing and analyzed with high-performance liquid chromatography/tandem mass spectrometry. Findings Consistent with findings on chronic disease, dose, age, sex, weight, and cigarettes/day accounted for some of the variability in olanzapine concentrations. While no relationship was found between olanzapine concentrations and adverse effects or improvement of depressive symptoms, response of psychotic symptoms was associated with concentrations between 22.56 and 77.92 ng/mL. Plasma breakpoints did not show sufficiently high specificity, resulting in a large number of false-positive results. Implications Although olanzapine concentrations do not seem to be reliable indicators of early drug effect in FEP, they may still prove useful for detecting noncompliance, as well as pharmacokinetically relevant comorbidities or genetic particularities in drug metabolism. PMID:28796022

Metabolic outcomes of bergamot polyphenolic fraction administration in patients treated with second-generation antipsychotics: a pilot study.

PubMed

Bruno, Antonio; Pandolfo, Gianluca; Crucitti, Manuela; Maisano, Antonino; Zoccali, Rocco A; Muscatello, Maria Rosaria Anna

2017-02-01

Second-generation antipsychotics (SGAs) are notoriously associated with a marked increase in body weight and with a wide range of metabolic adverse effects, and their chronic use is related with an increased risk for the development of metabolic syndrome (MS). Different adjunctive treatments have been proposed to reduce SGAs-induced weight gain and/or metabolic abnormalities with inconsistent or too limited evidence to support their regular clinical use, thus suggesting the need to find new possible treatments. Bergamot polyphenolic fraction (BPF) has been proven effective in patients with MS, as demonstrated by a concomitant improvement in lipemic and glycemic profiles. The present study was aimed to explore the efficacy and safety of BPF treatment on metabolic parameters in a sample of subjects receiving atypical antipsychotics. Fifteen outpatients treated with SGAs assumed BPF at the oral daily dose of 1000 mg/day for 30 days. Fasting levels of glucose, glycated hemoglobin, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol and triglycerides were determined. BPF administration resulted in a statistically significant reduction of body weight (P=.004) and in a trend for body mass index decrease (P=.005). No significant differences in other and metabolic parameters were observed. Our findings suggest that BPF, at the daily dose of 1000 mg for 30 days, could be an effective and safe agent to prevent weight gain associated with atypical antipsychotic use. However, further clinical trials with adequately powered and well-designed methodology are needed to better explore the BPF effectiveness on the SGAs-induced weight gain and metabolic side effects. Copyright © 2016 Elsevier Inc. All rights reserved.

Improvements in Irritability with Open-Label Methylphenidate Treatment in Youth with Comorbid Attention Deficit/Hyperactivity Disorder and Disruptive Mood Dysregulation Disorder.

PubMed

Winters, Drew E; Fukui, Sadaaki; Leibenluft, Ellen; Hulvershorn, Leslie A

2018-06-01

The purpose of this open-label study was to examine the effects of long-acting methylphenidate (MPH) treatment on irritability and related emotional symptoms associated with disruptive mood dysregulation disorder (DMDD) in youth with comorbid attention-deficit/hyperactivity disorder (ADHD). The sample included 22 medication-free male and female subjects (ages 9-15) who met criteria for both DMDD and ADHD. Participants underwent a 4-week trial of long-acting MPH treatment (Concerta ® ), with weekly dosing increases until a therapeutic dose was reached. Repeated measures t-tests were used to compare pre- and posttreatment ratings of primary and secondary measures. The primary outcome was self-report irritability. Secondary outcomes included parent and child ratings of emotional frequency, emotional lability, and negative affect (NA). Multiple regression was used to examine the impact baseline hyperactivity, age, gender, race, socioeconomic status, or comorbid diagnosis had on treatment outcomes. Significant improvements (medium to large effect sizes) in child-rated irritability as well as parent and child ratings of emotional lability, NA, and anger were found. As anticipated, ADHD symptoms also improved. While a majority of the sample saw improvement in child-rated irritability (71%), symptoms worsened a small proportion (19%), and an even smaller portion experienced no change (10%). No demographics, psychiatric comorbidities, or severity of ADHD symptoms influenced treatment outcomes. Study findings suggest that MPH treatment significantly improved mood and emotional symptoms associated with DMDD comorbid with ADHD. These findings, coupled with good tolerability in this open-label pilot study supports further research into the use of MPH as a first-line treatment for DMDD. Future work examining MPH treatment of youth with DMDD with and without comorbid ADHD is needed.

Memantine shows promise in reducing gambling severity and cognitive inflexibility in pathological gambling: a pilot study.

PubMed

Grant, Jon E; Chamberlain, Samuel R; Odlaug, Brian L; Potenza, Marc N; Kim, Suck Won

2010-12-01

Although pathological gambling (PG) is relatively common, pharmacotherapy research for PG is limited. Memantine, an N-methyl D-aspartate receptor antagonist, appears to reduce glutamate excitability and improve impulsive decision making, suggesting it may help individuals with PG. This study sought to examine the safety and efficacy of Memantine in PG. Twenty-nine subjects (18 females) with DSM-IV PG were enrolled in a 10-week open-label treatment study of memantine (dose ranging from 10 to 30 mg/day). Subjects were enrolled from January 2009 until April 2010. Change from baseline to study endpoint on the Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS) was the primary outcome measure. Subjects underwent pre- and post-treatment cognitive assessments using the stop-signal task (assessing response impulsivity) and the intra-dimensional/extra-dimensional (ID/ED) set shift task (assessing cognitive flexibility). Twenty-eight of the 29 subjects (96.6%) completed the 10-week study. PG-YBOCS scores decreased from a mean of 21.8 ± 4.3 at baseline to 8.9 ± 7.1 at study endpoint (p < 0.001). Hours spent gambling per week and money spent gambling both decreased significantly (p < 0.001). Subjects also demonstrated a significant improvement in ID/ED total errors (p = 0.037) at study endpoint. The mean effective dose of memantine was 23.4 ± 8.1 mg/day. The medication was well-tolerated. Memantine treatment was associated with diminished gambling and improved cognitive flexibility. These findings suggest that pharmacological manipulation of the glutamate system may target both gambling and cognitive deficits in PG. Placebo-controlled, double-blind studies are warranted in order to confirm these preliminary findings in a controlled design.

Ambroxol chaperone therapy for neuronopathic Gaucher disease: A pilot study.

PubMed

Narita, Aya; Shirai, Kentarou; Itamura, Shinji; Matsuda, Atsue; Ishihara, Akiko; Matsushita, Kumi; Fukuda, Chisako; Kubota, Norika; Takayama, Rumiko; Shigematsu, Hideo; Hayashi, Anri; Kumada, Tomohiro; Yuge, Kotaro; Watanabe, Yoriko; Kosugi, Saori; Nishida, Hiroshi; Kimura, Yukiko; Endo, Yusuke; Higaki, Katsumi; Nanba, Eiji; Nishimura, Yoko; Tamasaki, Akiko; Togawa, Masami; Saito, Yoshiaki; Maegaki, Yoshihiro; Ohno, Kousaku; Suzuki, Yoshiyuki

2016-03-01

Gaucher disease (GD) is a lysosomal storage disease characterized by a deficiency of glucocerebrosidase. Although enzyme-replacement and substrate-reduction therapies are available, their efficacies in treating the neurological manifestations of GD are negligible. Pharmacological chaperone therapy is hypothesized to offer a new strategy for treating the neurological manifestations of this disease. Specifically, ambroxol, a commonly used expectorant, has been proposed as a candidate pharmacological chaperone. The purpose of this study was to evaluate the safety, tolerability, and neurological efficacy of ambroxol in patients with neuronopathic GD. This open-label pilot study included five patients who received high-dose oral ambroxol in combination with enzyme replacement therapy. Safety was assessed by adverse event query, physical examination, electrocardiography, laboratory studies, and drug concentration. Biochemical efficacy was assessed through evidence of glucocerebrosidase activity in the lymphocytes and glucosylsphingosine levels in the cerebrospinal fluid. Neurological efficacy was evaluated using the Unified Myoclonus Rating Scale, Gross Motor Function Measure, Functional Independence Measure, seizure frequency, pupillary light reflex, horizontal saccadic latency, and electrophysiologic studies. High-dose oral ambroxol had good safety and tolerability, significantly increased lymphocyte glucocerebrosidase activity, permeated the blood-brain barrier, and decreased glucosylsphingosine levels in the cerebrospinal fluid. Myoclonus, seizures, and pupillary light reflex dysfunction markedly improved in all patients. Relief from myoclonus led to impressive recovery of gross motor function in two patients, allowing them to walk again. Pharmacological chaperone therapy with high-dose oral ambroxol shows promise in treating neuronopathic GD, necessitating further clinical trials.

Normal tissue complication probability (NTCP) parameters for breast fibrosis: pooled results from two randomised trials.

PubMed

Mukesh, Mukesh B; Harris, Emma; Collette, Sandra; Coles, Charlotte E; Bartelink, Harry; Wilkinson, Jenny; Evans, Philip M; Graham, Peter; Haviland, Jo; Poortmans, Philip; Yarnold, John; Jena, Raj

2013-08-01

The dose-volume effect of radiation therapy on breast tissue is poorly understood. We estimate NTCP parameters for breast fibrosis after external beam radiotherapy. We pooled individual patient data of 5856 patients from 2 trials including whole breast irradiation followed with or without a boost. A two-compartment dose volume histogram model was used with boost volume as the first compartment and the remaining breast volume as second compartment. Results from START-pilot trial (n=1410) were used to test the predicted models. 26.8% patients in the Cambridge trial (5 years) and 20.7% patients in the EORTC trial (10 years) developed moderate-severe breast fibrosis. The best fit NTCP parameters were BEUD3(50)=136.4 Gy, γ50=0.9 and n=0.011 for the Niemierko model and BEUD3(50)=132 Gy, m=0.35 and n=0.012 for the Lyman Kutcher Burman model. The observed rates of fibrosis in the START-pilot trial agreed well with the predicted rates. This large multi-centre pooled study suggests that the effect of volume parameter is small and the maximum RT dose is the most important parameter to influence breast fibrosis. A small value of volume parameter 'n' does not fit with the hypothesis that breast tissue is a parallel organ. However, this may reflect limitations in our current scoring system of fibrosis. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Optimisation of biocide dose as a function of residual biocide in a heat exchanger pilot plant effluent.

PubMed

Eguía, Emilio; Trueba, Alfredo; Girón, Alfredo; Río-Calonge, Belén; Otero, Félix; Bielva, Carlos

2007-01-01

Biofouling is one of the most serious problems facing numerous industrial processes. In the case of a heat exchanger unit, biological deposits adhering to the inside surface of its tubes reduce heat transfer and, thus, the thermal performance of the cycle. Control of this phenomenon is proving fundamental for both land and marine equipment to operate in optimum working conditions. Hence, it is necessary to apply antifouling methods capable of keeping surfaces free of any kind of biofouling. This paper reports on the behaviour resulting from use of the flow inversion method vs that obtained by using various chemical treatments. The study compares the effectiveness of certain chemical treatments (Na hypochlorite, peracetic acid and a compound formed by Na bromide + Na hypochlorite) for removing a biofouling film that has already formed on the inside surfaces of tubes in a heat exchanger pilot plant. The paper also addresses the issue of optimising the concentration of biocide dose as a function of the residual biocide in order minimise the environmental impact caused by effluent from industrial plants. The results indicate that it is possible to eliminate a biofilm formed on the inside surfaces of tubes by the use of intermittent doses of chemical treatments at low concentrations and over long application times. Furthermore, once the stabilisation phase is reached 6 d after starting the treatment, it is possible to maintain the conditions achieved using only 20% of the initial dosage.

Health Technology-Enabled Interventions for Adherence Support and Retention in Care Among US HIV-Infected Adolescents and Young Adults: An Integrative Review.

PubMed

Navarra, Ann-Margaret Dunn; Gwadz, Marya Viorst; Whittemore, Robin; Bakken, Suzanne R; Cleland, Charles M; Burleson, Winslow; Jacobs, Susan Kaplan; Melkus, Gail D'Eramo

2017-11-01

The objective of this integrative review was to describe current US trends for health technology-enabled adherence interventions among behaviorally HIV-infected youth (ages 13-29 years), and present the feasibility and efficacy of identified interventions. A comprehensive search was executed across five electronic databases (January 2005-March 2016). Of the 1911 identified studies, nine met the inclusion criteria of quantitative or mixed methods design, technology-enabled adherence and or retention intervention for US HIV-infected youth. The majority were small pilots. Intervention dose varied between studies applying similar technology platforms with more than half not informed by a theoretical framework. Retention in care was not a reported outcome, and operationalization of adherence was heterogeneous across studies. Despite these limitations, synthesized findings from this review demonstrate feasibility of computer-based interventions, and initial efficacy of SMS texting for adherence support among HIV-infected youth. Moving forward, there is a pressing need for the expansion of this evidence base.

The effects of oxytocin on eating behaviour and metabolism in humans.

PubMed

Lawson, Elizabeth A

2017-12-01

Oxytocin, a hypothalamic hormone that is secreted directly into the brain and enters the peripheral circulation through the posterior pituitary gland, regulates a range of physiologic processes, including eating behaviour and metabolism. In rodents and nonhuman primates, chronic oxytocin administration leads to sustained weight reduction by reducing food intake, increasing energy expenditure and inducing lipolysis. Oxytocin might improve glucose homeostasis, independently of its effects on weight. Clinical studies are beginning to translate these important preclinical findings to humans. This Review describes key data linking oxytocin to eating behaviour and metabolism in humans. For example, a single intranasal dose of oxytocin can reduce caloric intake, increase fat oxidation and improve insulin sensitivity in men. Furthermore, a pilot study of 8 weeks of oxytocin treatment in adults with obesity or overweight led to substantial weight loss. Together, these data support further investigation of interventions that target pathways involving oxytocin as potential therapeutics in metabolic disorders, including obesity and diabetes mellitus. Therapeutic considerations and areas for further research are also discussed.

Tumor promotion by exposure to radiofrequency electromagnetic fields below exposure limits for humans.

PubMed

Lerchl, Alexander; Klose, Melanie; Grote, Karen; Wilhelm, Adalbert F X; Spathmann, Oliver; Fiedler, Thomas; Streckert, Joachim; Hansen, Volkert; Clemens, Markus

2015-04-17

The vast majority of in vitro and in vivo studies did not find cancerogenic effects of exposure to electromagnetic fields (RF-EMF), i.e. emitted by mobile phones and base stations. Previously published results from a pilot study with carcinogen-treated mice, however, suggested tumor-promoting effects of RF-EMF (Tillmann et al., 2010). We have performed a replication study using higher numbers of animals per group and including two additional exposure levels (0 (sham), 0.04, 0.4 and 2 W/kg SAR). We could confirm and extend the originally reported findings. Numbers of tumors of the lungs and livers in exposed animals were significantly higher than in sham-exposed controls. In addition, lymphomas were also found to be significantly elevated by exposure. A clear dose-response effect is absent. We hypothesize that these tumor-promoting effects may be caused by metabolic changes due to exposure. Since many of the tumor-promoting effects in our study were seen at low to moderate exposure levels (0.04 and 0.4 W/kg SAR), thus well below exposure limits for the users of mobile phones, further studies are warranted to investigate the underlying mechanisms. Our findings may help to understand the repeatedly reported increased incidences of brain tumors in heavy users of mobile phones. Copyright © 2015 Elsevier Inc. All rights reserved.

Engagement for Enhancement: Report of a UK Survey Pilot

ERIC Educational Resources Information Center

Buckley, Alex

2013-01-01

This report presents the findings from a United Kingdom pilot of selected questions from the National Survey of Student Engagement (NSSE). 8,582 responses were gathered from nine institutions in Spring/Summer 2013. Also available to download are a full report of the cognitive testing by researchers from King's College London, a set of…

Providing Simulated Online and Mobile Learning Experiences in a Prison Education Setting: Lessons Learned from the PLEIADES Pilot Project

ERIC Educational Resources Information Center

Farley, Helen; Murphy, Angela; Bedford, Tasman

2014-01-01

This article reports on the preliminary findings, design criteria and lessons learned while developing and piloting an alternative to traditional print-based education delivery within a prison environment. PLEIADES (Portable Learning Environments for Incarcerated Distance Education Students), was designed to provide incarcerated students with…

EPA Region 10 Climate Change and TMDL Pilot – South Fork Nooksack River, Washington Final Report

EPA Science Inventory

This final report provides an overarching summary of the pilot research project, including the methods used in and the findings of the quantitative and qualitative assessments. It is written to appeal to a wide audience of policy makers, managers, agency staff and the general pub...

Illuminating the "Boy Problem" from Children's and Teachers' Perspectives: A Pilot Study

ERIC Educational Resources Information Center

Hamilton, Paula Louise; Jones, Louise

2016-01-01

The apparent educational underperformance of boys has received phenomenal attention worldwide for many years. In the UK, it has led to various government reports and policies aimed at raising boys' achievement. This small-scale qualitative-interpretive pilot study, undertaken in one urban primary school in North Wales, reports the findings from…

Design and Outcomes of a "Mothers In Motion" Behavioral Intervention Pilot Study

ERIC Educational Resources Information Center

Chang, Mei-Wei; Nitzke, Susan; Brown, Roger

2010-01-01

Objective: This paper describes the design and findings of a pilot "Mothers In Motion" (P-"MIM") program. Design: A randomized controlled trial that collected data via telephone interviews and finger stick at 3 time points: baseline and 2 and 8 months post-intervention. Setting: Three Special Supplemental Nutrition Program for…

Mobile Learning and Teacher Education: Researching MLEARN Pilot Development

ERIC Educational Resources Information Center

Passey, Don; Zozimo, Joana

2015-01-01

MLEARN, a European Union (EU)-funded project, is exploring and promoting teacher development of mobile learning practices in four member states--the Netherlands, the United Kingdom (UK) (England), Greece and Italy. This paper details the ways research findings have both fed into and been elicited from this pilot, supporting development and…

Online Activities of Urban Malaysian Adolescents: Report of a Pilot Study

ERIC Educational Resources Information Center

Tan, Kok Eng; Yen Abdullah, Melissa Ng Lee; Guan Saw, Kim

2012-01-01

The literacy practices of many communities today show new ways of meaning making in the contemporary, technological and digital culture. A number of Malaysian adolescents belong to this culture. This pilot study reports the preliminary findings of a larger study aimed at describing the online activities of Malaysian adolescents. Fifty-four…

Pilot Test of Standup, an Online School-Based Bullying Prevention Program

ERIC Educational Resources Information Center

Timmons-Mitchell, Jane; Levesque, Deborah A.; Harris, Leon A., III.; Flannery, Daniel J.; Falcone, Tatiana

2016-01-01

Bullying is a significant public health problem for students in schools. Prevention programs have addressed targets with some success; however, meta-analyses find small effects among older youths. A pilot study was conducted with high school students to evaluate the potential efficacy of StandUp, a three-session online program that delivers…

Pilot Study and Evaluation of Postgraduate Course on "The Interface Between Spirituality, Religion and Psychiatry"

ERIC Educational Resources Information Center

Grabovac, Andrea; Clark, Nancy; McKenna, Mario

2008-01-01

Objectives: Understanding the role of religion and spirituality is significant for psychiatric practice. Implementation of formal education and training on religious and spiritual issues, however, is lacking. Few psychiatric residencies offer mandatory courses or evaluation of course utility. The authors present findings from a pilot study of a…

A Glimpse beyond State Lines: Student Outcomes from WICHE's Multistate Longitudinal Data Exchange Pilot Project

ERIC Educational Resources Information Center

Bransberger, Peace

2014-01-01

This report presents findings from Western Interstate Commission for Higher Education's (WICHE) "Multistate Longitudinal Data Exchange Pilot" ("MLDE" or "Exchange"), which includes an array of analyses of the combined dataset covering 192,689 students from the four states (Hawai'i, Idaho, Oregon, and Washington) that…

An Investigation of Possible Correlations Between Individual Pilot Performance and Neurological Functions.

DTIC Science & Technology

1977-05-23

ed these findings with tests on peptic ulcer patients.1’ In 1949, Sau l , using a psychoanalytic approach in searching for correlates of personality...this area : PILOT PERFOR MANCE ANA L YSIS 1) With respect to the system developed and used for this study, research should be conducted to determine

Fighter pilots' heart rate, heart rate variation and performance during instrument approaches.

PubMed

Mansikka, Heikki; Simola, Petteri; Virtanen, Kai; Harris, Don; Oksama, Lauri

2016-10-01

Fighter pilots' heart rate (HR), heart rate variation (HRV) and performance during instrument approaches were examined. The subjects were required to fly instrument approaches in a high-fidelity simulator under various levels of task demand. The task demand was manipulated by increasing the load on the subjects by reducing the range at which they commenced the approach. HR and the time domain components of HRV were used as measures of pilot mental workload (PMWL). The findings of this study indicate that HR and HRV are sensitive to varying task demands. HR and HRV were able to distinguish the level of PMWL after which the subjects were no longer able to cope with the increasing task demands and their instrument landing system performance fell to a sub-standard level. The major finding was the HR/HRV's ability to differentiate the sub-standard performance approaches from the high-performance approaches. Practitioner Summary: This paper examined if HR and HRV were sensitive to varying task demands in a fighter aviation environment and if these measures were related to variations in pilot's performance.

High School-Based Treatment for Adolescents with Attention-Deficit/Hyperactivity Disorder: Results from a Pilot Study Examining Outcomes and Dosage

ERIC Educational Resources Information Center

Evans, Steven W.; Schultz, Brandon K.; DeMars, Christine E.

2014-01-01

The purpose of this study was to examine the efficacy and dose-response relationship of a school-based treatment program for high school students with attention-deficit/hyperactivity disorder (ADHD). Two paraprofessionals provided interventions to 24 students with ADHD randomly assigned to the treatment condition at two public high schools. They…

High-dose citalopram for cocaine dependence in veteran population-a pilot project.

PubMed

Vayalapalli, Sreedevi; Vaughn, Michael; Salles-Shahid, Khadijeh; Byrd-Sellers, Johnita; Drexler, Karen

2011-01-01

Cocaine dependence continues to be a highly prevalent disorder, which is associated with significant morbidity and mortality. Numerous medications have been investigated as potential adjunctive therapeutic measures, but with minimal success. None have been given Food and Drug Administration approval for treatment of cocaine dependence. (Am J Addict 2011;00:1-2). © American Academy of Addiction Psychiatry.

VITAMIN B-12 SUPPLEMENTATION OF DEFICIENT LACTATING GUATEMALAN WOMEN IMPROVES MATERNAL BUT NOT INFANT STATUS

USDA-ARS?s Scientific Manuscript database

Vitamin B-12 deficiency is common in mothers and infants where maternal intake of animals source foods is low. The first six months post-partum is a critical period of neurological development requiring vitamin B-12. A pilot study was designed to determine the dose of B-12 to the mothers that would ...

Quercetin decrease somatic cells count in mastitis of dairy cows.

PubMed

Burmańczuk, Artur; Hola, Piotr; Milczak, Andrzej; Piech, Tomasz; Kowalski, Cezary; Wojciechowska, Beata; Grabowski, Tomasz

2018-04-01

Quercetin is a dietary flavonoid which has an effect on inflammation, angiogenesis and vascular inflammation. In several other flavonoids (e.g. kaempferol, astragalin, alpinetin, baicalein, indirubin), anti-inflammatory mechanism was proven by using mice mastitis model. The aim of the current study was pilot analysis of quercetin tolerability and its impact on somatic cells count (SCC) after multiple intramammary treatment on dairy cows with clinical mastitis. Based on SCC and clinical investigation, 9 dairy cows with clinical mastitis of one quarter were selected for the pilot study. Baseline analysis (hematology, TNFα, SCC) was performed every 24h among all cows three days before the first dose (B1-B3). After the baseline monitoring (B1-B3) eight days treatment (D1-D8) was performed with a high and low dose. Selected blood parameters were analyzed. Starting from D1 to D8, a decrease of SCC in relation to baseline was characterized by declining trend. The presented results allowed the confirmation of the significant influence of quercetin on the reduction of SCC in mastitis in dairy cows after 8days of therapy. Copyright © 2018. Published by Elsevier Ltd.

UK Lung Cancer RCT Pilot Screening Trial: baseline findings from the screening arm provide evidence for the potential implementation of lung cancer screening

PubMed Central

Field, J K; Duffy, S W; Baldwin, D R; Whynes, D K; Devaraj, A; Brain, K E; Eisen, T; Gosney, J; Green, B A; Holemans, J A; Kavanagh, T; Kerr, K M; Ledson, M; Lifford, K J; McRonald, F E; Nair, A; Page, R D; Parmar, M K B; Rassl, D M; Rintoul, R C; Screaton, N J; Wald, N J; Weller, D; Williamson, P R; Yadegarfar, G; Hansell, D M

2016-01-01

Background Lung cancer screening using low-dose CT (LDCT) was shown to reduce lung cancer mortality by 20% in the National Lung Screening Trial. Methods The pilot UK Lung Cancer Screening (UKLS) is a randomised controlled trial of LDCT screening for lung cancer versus usual care. A population-based questionnaire was used to identify high-risk individuals. CT screen-detected nodules were managed by a pre-specified protocol. Cost effectiveness was modelled with reference to the National Lung Cancer Screening Trial mortality reduction. Results 247 354 individuals aged 50–75 years were approached; 30.7% expressed an interest, 8729 (11.5%) were eligible and 4055 were randomised, 2028 into the CT arm (1994 underwent a CT). Forty-two participants (2.1%) had confirmed lung cancer, 34 (1.7%) at baseline and 8 (0.4%) at the 12-month scan. 28/42 (66.7%) had stage I disease, 36/42 (85.7%) had stage I or II disease. 35/42 (83.3%) had surgical resection. 536 subjects had nodules greater than 50 mm3 or 5 mm diameter and 41/536 were found to have lung cancer. One further cancer was detected by follow-up of nodules between 15 and 50 mm3 at 12 months. The baseline estimate for the incremental cost-effectiveness ratio of once-only CT screening, under the UKLS protocol, was £8466 per quality adjusted life year gained (CI £5542 to £12 569). Conclusions The UKLS pilot trial demonstrated that it is possible to detect lung cancer at an early stage and deliver potentially curative treatment in over 80% of cases. Health economic analysis suggests that the intervention would be cost effective—this needs to be confirmed using data on observed lung cancer mortality reduction. Trial registration ISRCTN 78513845. PMID:26645413

A Randomized, Placebo-Controlled Pilot Study of Quetiapine-XR Monotherapy or Adjunctive Therapy to Antidepressant in Acute Major Depressive Disorder with Current Generalized Anxiety Disorder

PubMed Central

Li, Ranran; Wu, Renrong; Chen, Jun; Kemp, David E.; Ren, Ming; Conroy, Carla; Chan, Philip; Serrano, Mary Beth; Ganocy, Stephen J.; Calabrese, Joseph R.; Gao, Keming

2016-01-01

Objectives To pilot efficacy and safety data of quetiapine-XR monotherapy or adjunctive therapy to antidepressant(s) in the acute treatment of MDD with current generalized anxiety disorder (GAD). Methods The Mini International Neuropsychiatric Interview was used to ascertain the diagnosis of DSM-IV Axis I disorders. Eligible patients were randomly assigned to quetiapine-XR or placebo for up to 8 weeks. Changes from baseline to endpoint in Hamilton Depression Rating Scale-17 items (HAMD-17), Hamilton Anxiety Rating Scale (HAM-A), Clinical Global Impression-Severity (CGI-S), Quick Inventory of Depression Symptomatology-16 items Self-Report (QIDS-16-SR) total scores, and other outcome measures were analyzed with the last observation carried forward strategy and/or mixed-effects modeling for repeated measures. Results Of the 34 patients screened, 23 patients were randomized to receive quetiapine-XR (n = 11) or placebo (n = 12), with 5 and 4 completing the study, respectively. The mean dose of quetiapine-XR was 154 ± 91 mg/d. The change from baseline to endpoint in the total scores of HAMD-17, HAM-A, QIDS-16-SR, and CGI-S were significant in the quetiapine-XR group, but only the change in HAM-A total score was significant in the placebo group. The differences in these changes between the two groups were only significant in CGI-S scores, with the rest of numerical larger in the quetiapine-XR group. The most common side effects from quetiapine-XR were dry mouth, somnolence/sedation, and fatigue. Conclusions In this pilot study, quetiapine-XR was numerically superior to placebo in reducing depressive and anxiety symptoms in patients with MDD and current GAD. Large sample studies are warranted to support or refute these preliminary findings. PMID:27738370

Pharmacotherapy of Apnea by Cannabimimetic Enhancement, the PACE Clinical Trial: Effects of Dronabinol in Obstructive Sleep Apnea.

PubMed

Carley, David W; Prasad, Bharati; Reid, Kathryn J; Malkani, Roneil; Attarian, Hryar; Abbott, Sabra M; Vern, Boris; Xie, Hui; Yuan, Chengbo; Zee, Phyllis C

2018-01-01

There remains an important and unmet need for fully effective and acceptable treatments in obstructive sleep apnea (OSA). At present, there are no approved drug treatments. Dronabinol has shown promise for OSA pharmacotherapy in a small dose-escalation pilot study. Here, we present initial findings of the Phase II PACE (Pharmacotherapy of Apnea by Cannabimimetic Enhancement) trial, a fully blinded parallel groups, placebo-controlled randomized trial of dronabinol in people with moderate or severe OSA. By random assignment, 73 adults with moderate or severe OSA received either placebo (N = 25), 2.5 mg dronabinol (N = 21), or 10 mg dronabinol (N = 27) daily, 1 hour before bedtime for up to 6 weeks. At baseline, overall apnea-hypopnea index (AHI) was 25.9 ± 11.3, Epworth Sleepiness Scale (ESS) score was 11.45 ± 3.8, maintenance of wakefulness test (MWT) mean latency was 19.2 ± 11.8 minutes, body mass index was 33.4 ± 5.4 kg/m2, and age was 53.6 ± 9.0 years. The number and severity of adverse events, and treatment adherence (0.3 ± 0.6 missed doses/week) were equivalent among all treatment groups. Participants receiving 10 mg/day of dronabinol expressed the highest overall satisfaction with treatment (p = .04). In comparison to placebo, dronabinol dose-dependently reduced AHI by 10.7 ± 4.4 (p = .02) and 12.9 ± 4.3 (p = .003) events/hour at doses of 2.5 and 10 mg/day, respectively. Dronabinol at 10 mg/day reduced ESS score by -3.8 ± 0.8 points from baseline (p < .0001) and by -2.3 ± 1.2 points in comparison to placebo (p = .05). MWT sleep latencies, gross sleep architecture, and overnight oxygenation parameters were unchanged from baseline in any treatment group. These findings support the therapeutic potential of cannabinoids in people with OSA. In comparison to placebo, dronabinol was associated with lower AHI, improved self-reported sleepiness, and greater overall treatment satisfaction. Larger scale clinical trials will be necessary to clarify the best potential approach(es) to cannabinoid therapy in OSA. © Sleep Research Society 2017. Published by Oxford University Press on behalf of the Sleep Research Society. All rights reserved. For permissions, please e-mail journals.permissions@oup.com.

The RTS,S/AS01 malaria vaccine in children 5 to 17 months of age at first vaccination.

PubMed

Vandoolaeghe, Pascale; Schuerman, Lode

2016-12-01

The RTS,S/AS01 malaria vaccine received a positive scientific opinion from the European Medicines Agency in July 2015. The World Health Organization recommended pilot implementation of the vaccine in children at least 5 months of age according to an initial 3-dose schedule given at least 1 month apart, and a 4th dose 15-18 months post-dose 3. Clinical trials and mathematical modeling demonstrated that the partial protection provided by RTS,S/AS01 against malaria has the potential to provide substantial public health benefit when used in parallel with other malaria interventions, especially in highly endemic regions. The highest impact was seen with 4 vaccine doses in children aged 5 months or older. The vaccine will be evaluated in real-life settings to further assess its impact on mortality, vaccine safety in the context of routine immunization, and programmatic feasibility of delivering a 4-dose vaccination schedule requiring new immunization contacts. If successful, this will pave the way for larger-scale implementation.

Nuclear emulsion measurements of the dose contribution from tissue disintegration stars on the Apollo-Soyuz mission

NASA Technical Reports Server (NTRS)

Schaefer, H. J.

1977-01-01

A total of 996 disintegration stars were prong-counted in two 100 micron llford K.2 emulsions from the dosimeter of the Docking Pilot on Apollo-Soyuz. The change of slope of the distribution at a prong number of about 6 or 7 indicates 219 stars as originating in gelatin. Applying the QF values set forth in official regulations to the energy spectra of the proton and a alpha prongs of the gelatin stars leads to a tissue star dose of 7.8 millirad or 45 millirem. The quoted values do not include the dose contribution from star-produced neutrons since neutrons do not leave visible prongs in emulsion. Nuclear theory, in good agreement with measurements of galactic radiation in the earth's atmosphere, indicates that the dose equivalent from neutrons is about equal to the one from all ionizing secondaries of stars. Application of this proposition to the star prong spectrum found on Apollo-Soyuz would set the total tissue star dose for the mission at approximately 90 millirem.

Pilot Mental Health, Negative Life Events, and Improving Safety with Peer Support and a Just Culture.

PubMed

Mulder, Sanne; de Rooy, Diederik

2018-01-01

In the last 35 yr, 17 commercial aviation accidents and incidents, with 576 fatalities, could likely have been attributed to mental disease of a pilot. Screening tools for mental health risks in airline pilots are needed. There is growing interest in pilot peer-support programs and how to incorporate them in a just culture, meaning that pilots can report mental health complaints without a risk of job or income loss. We combined findings from aviation accidents and incidents with a search of scientific literature to provide data-based recommendations for screening, peer-support, and a just culture approach to mental health problems. Commercial aviation accidents and incidents in which a mental disorder of a pilot was thought to play a role were reviewed. Subsequently, PubMed and PsychInfo literature searches were performed on peer-support programs, just culture human resource management, and the risk of negative life events on developing suicidal ideation and behavior in comparable professional groups. Lethal accidents were mostly related to impaired coping with negative life events. Negative life events are clearly related to suicidal thoughts, attempts, and completed suicide. A protective effect of peer-support programs on mental health problems has not been established, although peer-support programs are generally appreciated by those involved. We did not find relevant literature on just culture. Negative life events are likely a useful screening tool for mental health risks. There is still a lack of evidence on how peer-support groups should be designed and how management of mental health risks can be implemented in a just culture.Mulder S, de Rooy D. Pilot mental health, negative life events, and improving safety with peer support and a just culture. Aerosp Med Hum Perform. 2018; 89(1):41-51.

Pilot performance

NASA Technical Reports Server (NTRS)

Nicholls, Jennifer

1988-01-01

For many years, the emphasis has been placed on the performance of the aircraft, rather than on those who fly the aircraft. This is largely due to the relative safety of flying. Just in the last few years there have been several major accidents that have shown that flying is not quite as safe as it was thought to be. Sixty-five percent of these accidents are a result of pilot performance decrements, and so it is obvious that there is a need to reduce that figure. A study has been mandated to evaluate the performance of pilots. This includes workload, circadium rhythms, jet lag, and any other factors which might affect a pilot's performance in the cockpit. The purpose of this study is to find out when and why the decrement in a pilot's performance occur and how to remedy the situation.

Safety and immunogenicity of pneumococcal protein vaccine candidates: monovalent choline-binding protein A (PcpA) vaccine and bivalent PcpA-pneumococcal histidine triad protein D vaccine.

PubMed

Bologa, Monica; Kamtchoua, Thierry; Hopfer, Robert; Sheng, Xiaohua; Hicks, Bryony; Bixler, Garvin; Hou, Victor; Pehlic, Vildana; Yuan, Tao; Gurunathan, Sanjay

2012-12-14

Pneumococcal vaccines based on protein antigens may provide expanded protection against Streptococcus pneumoniae. To evaluate safety and immunogenicity in adults of pneumococcal vaccine candidates comprising S. pneumoniae pneumococcal histidine triad protein D (PhtD) and pneumococcal choline-binding protein A (PcpA) in monovalent and bivalent formulations. This was a phase I, randomized, observer-blinded, placebo-controlled, step-wise dose-escalation study. Following a pilot safety study in which participants received one intramuscular injection of either aluminum hydroxide (AH)-adjuvanted PcpA (25 μg) or PhtD-PcpA (10 μg each), participants in the main study received AH-adjuvanted PcpA (25 μg), AH-adjuvanted PhtD-PcpA (10, 25, or 50 μg each), unadjuvanted PhtD-PcpA (25 μg each), or placebo as 2 injections 30 days apart. Assignment of successive dose cohorts was made after blinded safety reviews after each dose level. Safety endpoints included rates of solicited injection site and systemic reactions, unsolicited adverse events (AEs), serious AEs (SAEs), and safety laboratory tests. Immunogenicity endpoints included levels of anti-PhtD and anti-PcpA antibodies (ELISA). Six adults 18-50 years of age were included in the pilot study and 125 in the main study. No obvious increases in solicited reactions or unsolicited AEs were reported with escalating doses (adjuvanted vaccine) after either injection, or with repeated administration. Adjuvanted vaccine candidates were associated with a higher incidence of solicited reactions (particularly injection site reactions) than unadjuvanted vaccine candidates. However, no SAE or discontinuation due to an AE occurred. Geometric mean concentrations of anti-PhtD IgG and anti-PcpA IgG increased significantly after injection 2 compared with injection 1 at each dose level. No enhancement of immune responses was shown with adjuvanted vaccine candidates compared with the unadjuvanted vaccine candidate. In the dose-escalating comparison, a plateau effect at the 25 μg dose was observed as measured by geometric mean concentrations and by fold increases. Promising safety profiles and immunogenicity of these monovalent and bivalent protein vaccine candidates were demonstrated in an adult population (ClinicalTrials.gov registry no. NCT01444339). Copyright © 2012 Elsevier Ltd. All rights reserved.

Modeling adverse event counts in phase I clinical trials of a cytotoxic agent.

PubMed

Muenz, Daniel G; Braun, Thomas M; Taylor, Jeremy Mg

2018-05-01

Background/Aims The goal of phase I clinical trials for cytotoxic agents is to find the maximum dose with an acceptable risk of severe toxicity. The most common designs for these dose-finding trials use a binary outcome indicating whether a patient had a dose-limiting toxicity. However, a patient may experience multiple toxicities, with each toxicity assigned an ordinal severity score. The binary response is then obtained by dichotomizing a patient's richer set of data. We contribute to the growing literature on new models to exploit this richer toxicity data, with the goal of improving the efficiency in estimating the maximum tolerated dose. Methods We develop three new, related models that make use of the total number of dose-limiting and low-level toxicities a patient experiences. We use these models to estimate the probability of having at least one dose-limiting toxicity as a function of dose. In a simulation study, we evaluate how often our models select the true maximum tolerated dose, and we compare our models with the continual reassessment method, which uses binary data. Results Across a variety of simulation settings, we find that our models compare well against the continual reassessment method in terms of selecting the true optimal dose. In particular, one of our models which uses dose-limiting and low-level toxicity counts beats or ties the other models, including the continual reassessment method, in all scenarios except the one in which the true optimal dose is the highest dose available. We also find that our models, when not selecting the true optimal dose, tend to err by picking lower, safer doses, while the continual reassessment method errs more toward toxic doses. Conclusion Using dose-limiting and low-level toxicity counts, which are easily obtained from data already routinely collected, is a promising way to improve the efficiency in finding the true maximum tolerated dose in phase I trials.

Isotonic designs for phase I trials in partially ordered groups.

PubMed

Conaway, Mark

2017-10-01

Dose-finding trials can be conducted such that patients are first stratified into multiple risk groups before doses are allocated. The risk groups are often completely ordered in that, for a fixed dose, the probability of toxicity is monotonically increasing across groups. In some trials, the groups are only partially ordered. For example, one of several groups in a trial may be known to have the least risk of toxicity for a given dose, but the ordering of the risk among the remaining groups may not be known. The aim of the article is to introduce a method for designing dose-finding trials of cytotoxic agents in completely or partially ordered groups of patients. This article presents a method for dose-finding that combines previously proposed mathematical models, augmented with results using order restricted inference. The resulting method is computationally convenient and allows for dose-finding in trials with completely or partially ordered groups. Extensive simulations are done to evaluate the performance of the method, using randomly generated dose-toxicity curves where, within each group, the risk of toxicity is an increasing function of dose. Our simulations show that the hybrid method, in which order-restricted estimation is applied to parameters of a parsimonious mathematical model, gives results that are similar to previously proposed methods for completely ordered groups. Our method generalizes to a wide range of partial orders among the groups. The problem of dose-finding in partially ordered groups has not been extensively studied in the statistical literature. The proposed method is computationally feasible, and provides a potential solution to the design of dose-finding studies in completely or partially ordered groups.

Idiopathic Syringomyelia in a Military Helicopter Pilot.

PubMed

Schiemer, Anthony

2017-10-01

A syrinx is a fluid-filled cavity within the spinal cord. They can lead to a variety of symptoms, including limb weakness and back pain. Incidental finding of syringomyelia provides a challenge for clinicians due to the wide variety of possible symptoms. In military aviation, neurological findings in pilots can result in extensive investigation that can lead to potentially invasive management. Conversely, the potential for chronic progression of a spinal syrinx and subsequent neurological deterioration makes early identification critical. Ultimately, the discovery of a lesion may have implications for flying status and operational capability. A 25-yr-old man working as a navy Seahawk helicopter pilot presented with episodes of right arm paraesthesia and pain between the scapulae. On at least one occasion, these symptoms woke him at night. Upon magnetic resonance imaging, dilatation of the central canal in a syrinx-like pattern in the lower cervical region was noted. Neurology review suggested the finding was persistent and unlikely to be responsible for his symptoms. No surgical input was recommended. His symptoms were attributed to mild cervical spondylosis, which resolved with ongoing physiotherapy, and he was returned to flying status. This case highlights several issues involved with the incidental finding of a syringomyelia. Surgical intervention has been known to worsen symptoms. Conversely, studies have identified minimal radiological progression in cases of idiopathic syringomyelia, with fewer individuals displaying neurological deterioration. For aircrew, potentially unnecessary neurosurgical intervention poses risks to a flying career and overall operational capability.Schiemer A. Idiopathic syringomyelia in a military helicopter pilot. Aerosp Med Hum Perform. 2017; 88(10):962-965.

Dementia buddying as a vehicle for person-centred care? The performance of a volunteer-led pilot on two hospital wards.

PubMed

Preston, Claire; Burch, Sarah

2018-01-01

Objectives To understand and explain whether a dementia buddies pilot introduced into two adjacent mental health hospital wards in England was achieving its aim of enhancing person-centred care. Methods The research used a cultural lens to evaluate the dementia buddies pilot. It comprised 20 in-depth semi-structured interviews with staff, volunteers and carers in the two wards where the pilot was introduced. Results The pilot's ability to deliver positive outcomes depended on its compatibility with the culture of the ward and it performed better in the ward where a person-centred culture of care already existed. In this ward, the pilot became a catalyst for improved experience among patients, carers and staff, whereas in the second ward, the pilot faced resistance from staff and achieved less. Conclusions This finding underlines the benefit of focusing on workplace culture to understand the performance of volunteer-led initiatives. It also shows that existing ward culture is a determining factor in the capacity for dementia buddy schemes to act as vehicles for culture change.

Twice-daily dosing of temozolomide in combination with fotemustine for the treatment of patients with refractory glioblastoma.

PubMed

Santoni, M; Paccapelo, A; Burattini, L; Onofri, A; Cascinu, S

2012-03-01

Alkylating agents, such as temozolomide (TMZ) and fotemustine (FTM) are widely used in recurrent glioblastoma (GBM) regimes. Several strategies have been proposed to prevent resistance to these agents, by combining or sequencing them. We report the results of a pilot study of patients with refractory GBM receiving a regime of twice-daily dosing of temozolomide administered on day 1, (with an initial oral dose of 200 mg/m(2) and a second oral dose of 75 mg/m(2) 12 h later), followed by fotemustine in a single i.v. infusion at 75 mg/m(2) on day 2, repeated every four weeks. Enrolment was stopped at 15 patients due to lack of effectiveness of this schedule for patients with GBM. Toxicity was mild, with no grade 4 side effects reported. Results indicate that our temozolomide -FTM combined schedule is not effective, although well tolerated, in non responsive patients with GBM. Further strategies are required to improve the outcome of these patients.

Human adipose-derived mesenchymal stem cells for osteoarthritis: a pilot study with long-term follow-up and repeated injections.

PubMed

Song, Yang; Du, Hui; Dai, Chengxiang; Zhang, Li; Li, Suke; Hunter, David J; Lu, Liangjing; Bao, Chunde

2018-04-01

This study aimed to evaluate the safety and therapeutic potential of autologous human adipose-derived mesenchymal stem cells (haMSCs) in patients with osteoarthritis. Safety and efficacy of haMSCs were preclinically assessed in vitro and in BALB/c-nu nude mice. 18 patients were enrolled and divided into three dose groups: the low-dose, mid-dose and high-dose group (1 × 10 7 , 2 × 10 7 and 5 × 10 7 cells, respectively), provided three injections and followed up for 96 weeks. The preclinical study established the safety and efficacy of haMSCs. Intra-articular injections of haMSCs were safe and improved pain, function and cartilage volume of the knee joint, rendering them a promising novel treatment for knee osteoarthritis. The dosage of 5 × 10 7 haMSCs exhibited the highest improvement (ClinicalTrials.gov Identifier: NCT01809769).

Long-term effects of exercise programs among helicopter pilots with flying related LBP

PubMed Central

Andersen, Knut; Baardsen, Roald; Dalen, Ingvild; Larsen, Jan Petter

2017-01-01

BACKGROUND: Flying related transient Low Back Pain (LBP) among helicopter pilots is considered an occupational distress. OBJECTIVE: To examine if exercise programs can alleviate transient LBP. METHODS: Sixty-five helicopter pilots (92% males), all reporting flying related LBP, responded to an epidemiological survey and a long-term follow-up, 44.8 months later, comprising questions regarding transient LBP and number of sick leaves. Data from 37 pilots participating in two exercise programs, A; general for LBP, B; focused for lumbar trunk (LT), included information from clinical examinations and muscular endurance tests of the LT before and after intervention. Twenty-eight pilots did not participate in any intervention. RESULTS: At long-term follow-up 42% of the pilots still reported flying related transient LBP. Among participants in program B 26% had persistent pain, 70% in program A and 46% among pilots without intervention. Sick-leave reduction was only observed among participants in program B (30% to 4%). Upon re-occurrence of LBP symptoms, half of the pilots in program B again performed exercises to improve their pain. CONCLUSION: This study indicates that exercise programs focused towards lumbar trunk muscular endurance reduces flying related transient LBP and sick-leave among helicopter pilots. These findings may have implications for the pilots’ working conditions. PMID:29278872

Les annees de transition: une epoque de changement. Reveu et analyse des projets pilotes sur les questions relatives aux annees de Transition. Volume 1: Resume (Year of Transition: Times for Change. A Review and Analysis of Pilot Projects Investigating Issues in the Transition Years. Volume 1: Summary).

ERIC Educational Resources Information Center

Hargreaves, Andy; And Others

In 1990, the Ontario (Canada) Ministry of Education implemented the Transition Years project, an initiative for restructuring middle-grades education. This French-language document presents findings of a study that identified effective policies and practices used by the pilot schools. Data were derived from: (1) surveys completed by staffs in…

A recommended epidemiological study design for examining the adverse health effects among emergency workers who experienced the TEPCO fukushima daiichi NPP accident in 2011.

PubMed

Yasui, Shojiro

2016-01-01

Results from medical examinations conducted in 2012 of workers who were engaged in radiation work in 2012 as a result of the 2011 Fukushima Daiichi Nuclear Power Plant (NPP) accident showed that the prevalence of abnormal findings was 4.21%, 3.23 points higher than the 0.98% that was found prior to the accident in the jurisdiction area of the labor inspection office which holds jurisdiction over the NPP. The Ministry of Health, Labour and Welfare (MHLW) concluded that the 2010 and 2012 data cannot be easily compared because 70% of the enterprises within the jurisdiction of the office that reported the 2012 results were different from those that did so in 2010. In addition, although the radiation workers' estimated average dose weighted by number of workers was 3.66 times higher than decontamination workers' dose, the prevalence among radiation workers was only 1.14 times higher than that among decontamination workers. Based on the results of the medical examinations, however, the MHLW decided to implement an epidemiological study on the health effects of radiation exposure on all emergency workers. This article explains key issues of the basic design of the study recommended by the expert meeting established in the MHLW and also identifies challenges that could not be resolved and thus required further consideration by the study researchers. The major issues included: (a) study methods and target group; (b) evaluation of cumulative doses; (c) health effects (end points); (d) control of confounding factors; and (e) study implementation framework. Identified key challenges that required further deliberation were: (a) preventing arbitrary partisan analysis; (b) ensuring a high participation rate; (c) inquiry about the medical radiation doses; and (d) the preparedness of new analytical technology. The study team formulated and implemented the pilot study in 2014 and started the full-scale study in April 2015 with funding from a research grant from the MHLW.

Cervical and lumbar pain and radiological degeneration among fighter pilots: a systematic review and meta-analysis.

PubMed

Shiri, Rahman; Frilander, Heikki; Sainio, Markku; Karvala, Kirsi; Sovelius, Roope; Vehmas, Tapio; Viikari-Juntura, Eira

2015-02-01

To assess the associations of acceleration force indicators (aircraft type and flight hours) with cervical and lumbar pain and radiological degeneration among fighter pilots. The PubMed, Embase, Scopus and Web of Science databases were searched until October 2013. Twenty-seven studies were included in the review and 20 in the meta-analysis. There were no differences in the prevalence of neck pain (pooled OR=1.07, 95% CI 0.87 to 1.33), cervical disc degeneration (OR=1.26, CI 0.81 to 1.96), low back pain (OR=0.80, CI 0.47 to 1.38) or lumbar disc degeneration (OR=0.87, CI 0.67 to 1.13) between fighter pilots and helicopter or transport/cargo pilots. Moreover, the prevalence of cervical (OR=1.14, CI 0.61 to 2.16) or lumbar (OR=1.05, CI 0.49 to 2.26) disc degeneration did not differ between fighter pilots and non-flying personnel. Most studies did not control their estimates for age and other potential confounders. Among high-performance aircraft pilots, exposure to the highest G-forces was associated with a higher prevalence of neck pain compared with exposure to lower G-forces (pooled OR=3.12, CI 2.08 to 4.67). The studies on the association between flight hours and neck pain reported inconsistent findings. Moreover, looking back over the shoulder (check six) was the most common posture associated with neck pain. Fighter pilots exposed to high G-forces may be at a greater risk for neck pain than those exposed to low G-forces. This finding should be confirmed with better control for confounding. Awkward neck posture may be an important factor in neck pain among fighter pilots. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

An assessment of predominant causal factors of pilot deviations that contribute to runway incursions

NASA Astrophysics Data System (ADS)

Campbell, Denado M.

The aim of this study was to identify predominant causal factors of pilot deviations in runway incursions over a two-year period. Runway incursion reports were obtained from NASA's Aviation Safety Reporting System (ASRS), and a qualitative method was used by classifying and coding each report to a specific causal factor(s). The causal factors that were used were substantiated by research from the Aircraft Owner's and Pilot's Association that found that these causal factors were the most common in runway incursion incidents and accidents. An additional causal factor was also utilized to determine the significance of pilot training in relation to runway incursions. From the reports examined, it was found that miscommunication and situational awareness have the greatest impact on pilots and are most often the major causes of runway incursions. This data can be used to assist airports, airlines, and the FAA to understand trends in pilot deviations, and to find solutions for specific problem areas in runway incursion incidents.

Winged Auxiliaries: Women Pilots in the UK and US during World War Two

NASA Astrophysics Data System (ADS)

Schrader, Helena P.

2006-05-01

During World War II women in the US and the UK were given the then unprecedented opportunity to fly military aircraft. Yet while the women flying in the UK soon gained the privileges and status enjoyed by their male colleagues, the American women pilots were expressly denied the same status, rank, pay, and benefits as USAAF pilots. In fact, after an ugly slander campaign against the women pilots' organisation, the US programme was discontinued and the women were sent home before their job was done. The American women pilots were not less dedicated or inherently less capable than the women flying in Britain. Rather, key environmental and organisational differences and above all a failure of leadership accounts for their fate. This paper summarises the differences and their impact. The complete findings of the comparative research on the experiences of women pilots in the US and the UK during WWII will be published by Pen & Sword Books Inc early in 2006 under the title Sisters in Arms.

Revisiting Dosing Regimen Using Pharmacokinetic/Pharmacodynamic Mathematical Modeling: Densification and Intensification of Combination Cancer Therapy.

PubMed

Meille, Christophe; Barbolosi, Dominique; Ciccolini, Joseph; Freyer, Gilles; Iliadis, Athanassios

2016-08-01

Controlling effects of drugs administered in combination is particularly challenging with a densified regimen because of life-threatening hematological toxicities. We have developed a mathematical model to optimize drug dosing regimens and to redesign the dose intensification-dose escalation process, using densified cycles of combined anticancer drugs. A generic mathematical model was developed to describe the main components of the real process, including pharmacokinetics, safety and efficacy pharmacodynamics, and non-hematological toxicity risk. This model allowed for computing the distribution of the total drug amount of each drug in combination, for each escalation dose level, in order to minimize the average tumor mass for each cycle. This was achieved while complying with absolute neutrophil count clinical constraints and without exceeding a fixed risk of non-hematological dose-limiting toxicity. The innovative part of this work was the development of densifying and intensifying designs in a unified procedure. This model enabled us to determine the appropriate regimen in a pilot phase I/II study in metastatic breast patients for a 2-week-cycle treatment of docetaxel plus epirubicin doublet, and to propose a new dose-ranging process. In addition to the present application, this method can be further used to achieve optimization of any combination therapy, thus improving the efficacy versus toxicity balance of such a regimen.

[Comparative study on the tolerance and efficacy of high doses of metoclopramide and clebopride in vomiting induced by cisplatin].

PubMed

Martín, M; Díaz-Rubio, E

1989-06-10

Forty-one patients treated with cisplatin (100-120 mg/m2), alone or associated with vindesine (3 mg/m2), were included in a randomized crossover pilot study which compared 3 different doses of intravenous clebopride with intravenous metoclopramide. The patients were randomly assigned to receive clebopride in the first chemotherapy course in one of the three dose levels used (0.5 mg/kg, 21 patients; 0.75 mg/kg, 11 patients; 1 mg/kg, 10 patients) or metoclopramide (10 mg/kg). In the second course of the same chemotherapy the patients received the alternative antiemetic, and thus each patient was his own control. The total dose of both antiemetic drugs was infused in 5 intravenous fractions given every 2 hours. The antiemetic activity of clebopride was moderately lower to that of metoclopramide with the first two tested doses (overall doses of 0.5 and 0.75 mg/kg) and similar with the last dose (1 mg/kg). Clebopride was reasonably well tolerated at the used dosages, inducing sedation in 20% of cases (versus 24% with metoclopramide) and diarrhea in 37% (versus 20% with metoclopramide). Extrapyramidal reactions developed in 17% of the courses which included metoclopramide and in none including clebopride. This difference was statistically significant.

Pilot Evaluation of a Web-Based Intervention Targeting Sexual Health Service Access

ERIC Educational Resources Information Center

Brown, K. E.; Newby, K.; Caley, M.; Danahay, A.; Kehal, I.

2016-01-01

Sexual health service access is fundamental to good sexual health, yet interventions designed to address this have rarely been implemented or evaluated. In this article, pilot evaluation findings for a targeted public health behavior change intervention, delivered via a website and web-app, aiming to increase uptake of sexual health services among…

A Report on Student Achievement in a Pilot Program for Developmental Students.

ERIC Educational Resources Information Center

Best, Linda; Fung, Terry Y.

2001-01-01

Reports on the first phase of a two-year pilot study of a university-level mathematics requirement that accommodates the needs of developmental students. Finds that the 84% pass rate for this new class format is substantially higher than the 43% pass rate for traditional developmental mathematics courses offered during the same semester. (Contains…

Evaluation of the Texas Technology Immersion Pilot: Findings from the Second Year

ERIC Educational Resources Information Center

Shapley, Kelly; Sheehan, Daniel; Maloney, Catherine; Caranikas-Walker, Fanny; Huntsberger, Briana; Sturges, Keith

2007-01-01

The Technology Immersion Pilot (TIP) sets forth a vision for technology immersion in Texas public schools. The Texas Education Agency (TEA) originally directed more than $14.5 million in federal Title II, Part D monies toward funding a wireless learning environment for high-need middle schools through a competitive grant process. A concurrent…

Career Education Pilot Project K-14. Orange County Consortium. Needs Assessment.

ERIC Educational Resources Information Center

Schrodi, Tom; And Others

Summarized are the outcomes of a needs assessment of the Career Education Pilot Project for grades K-14 conducted in the Orange County (California) Consortium. Interviews and questionnaires were used to obtain data from teachers, students, and parents on the target area as well as from 150 service agencies in the communities. Findings include: (1)…

Connecting Students to Mental Health Care: Pilot Findings from an Engagement Program for School Nurses

ERIC Educational Resources Information Center

Kim, Rachel E.; Becker, Kimberly D.; Stephan, Sharon H.; Hakimian, Serop; Apocada, Dee; Escudero, Pia V.; Chorpita, Bruce F.

2015-01-01

Schools function as the major provider of mental health services (MHS) for youth, but can struggle with engaging them in services. School nurses are well-positioned to facilitate referrals for MHS. This pilot study examined the feasibility, acceptability, and preliminary efficacy of an engagement protocol (EP) designed to enhance school nurses'…

Self-Insurance: A Solution for Faculty and Staff Health Promotion? Pilot Study Findings

ERIC Educational Resources Information Center

Giebert, Megan C. H.; Wilson, Kelly L.; Ward, Susan E.

2014-01-01

Faculty and staff health promotion is a cost-saving component of coordinated school health, but little is known about the comprehensiveness of these programs. Self-insured school districts require employees to contribute directly to the district's health insurance pool. The purpose of this pilot study was to identify the prevalence of…

Job Strategies for Urban Youth. Sixteen Pilot Programs for Action.

ERIC Educational Resources Information Center

Work in America Inst., Scarsdale, NY.

Developed by a study concerned with urban youth unemployment, this report provides descriptions of sixteen pilot projects intended to find or create unsubsidized jobs for youth, help them prepare for these jobs, and bring youth and jobs together. Based on the theme that unemployment results not from lack of will to work but from lack of…

Summer School Pilot 1983: Second Report to the Texas Education Agency.

ERIC Educational Resources Information Center

Austin Independent School District, TX. Office of Research and Evaluation.

The Austin (TX) Independent School District presents its second report to the Texas Education Agency concerning the Summer School Pilot 1983. It contains a final report summary, a teacher checklist, and an observation followup. The report summary includes the following major findings: (1) retainees who attended summer school and those who did not…

Income Verification Pilot Project (Phase II): Results of Quality Assurance Evaluation, 1982-83 School Year.

ERIC Educational Resources Information Center

Applied Management Sciences, Inc., Silver Spring, MD.

Presented in this report are selected findings of the Income Verification Pilot Project (IVPP), an investigation examining misreporting of applicant income and family size on applications for government-sponsored school meal benefits. As reported here, Phase II of the project provided for a comprehensive assessment of specific quality assurance…

Measuring the Impact of a Pilot Geospatial Technology Apprenticeship Program for the Department of Labor

ERIC Educational Resources Information Center

Gaudet, Cyndi; Annulis, Heather; Kmiec, John

2010-01-01

The Geospatial Technology Apprenticeship Program (GTAP) pilot was designed as a replicable and sustainable program to enhance workforce skills in geospatial technologies to best leverage a $30 billion market potential. The purpose of evaluating GTAP was to ensure that investment in this high-growth industry was adding value. Findings from this…

Shaken and Stirred: A Pilot Project in Arts and Special Education

ERIC Educational Resources Information Center

Ponder, Carol; Kissinger, Lori

2009-01-01

In this article, the authors describe VSA arts Tennessee's pilot arts in education project and the many good questions that have arisen from it. From VSA's inception in 2002, Lori Kissinger, Executive Director of VSA Tennessee, planned to find a way to partner with the Tennessee Department of Education based on other state models. VSA arts…

Mentoring in the Juvenile Justice System: Findings from Two Pilot Programs.

ERIC Educational Resources Information Center

Mecartney, Crystal A.; And Others

This study examined two pilot mentoring programs which were designed to provide information on the feasibility of integrating mentoring relationships into the juvenile justice system. Each program, one in St. Louis, Missouri and one in Atlanta, Georgia, sought to recruit, train, and match 100 adult volunteers (half over the age of 55) with 100…

Characteristics of Difficult-to-Place Youth in State Custody: A Profile of the Exceptional Care Pilot Project Population

ERIC Educational Resources Information Center

Armour, Marilyn P.; Schwab, James

2007-01-01

This study examines the characteristics of Texas youth designated as "most difficult to place" recipients of service under the "Exceptional Care Pilot Project" (N = 46). Findings include, among others, high levels of comorbid psychiatric disturbance (greater than 3 diagnostic groupings), physical (78.3%) and sexual (88%)…

Pilot Study for the Active TV Viewer Scholar Education. Final Report. Years 1984-1985.

ERIC Educational Resources Information Center

Torres, Miguel Reyes

The purposes of the "Pilot Study for the Active TV Viewer Scholar Education" project were to find low cost teaching methods that developed critical television viewing skills among elementary and secondary students, and to develop a parallel program of family education in an effort to modify family viewing practices to encourage critical…

Eco-School in Kindergartens: The Effects, Interpretation, and Implementation of a Pilot Program

ERIC Educational Resources Information Center

Cincera, Jan; Kroufek, Roman; Simonova, Petra; Broukalova, Lenka; Broukal, Vaclav; Skalík, Jan

2017-01-01

This study presents an analysis of a Czech pilot project in implementing the Eco-School program in kindergartens. The evaluation applied a mixed design that included pre/post testing of children using picture-based questionnaires, and interviews with the teachers responsible for conducting the program. The findings revealed a significant increase…

Withaferin A effectively targets soluble vimentin in the glaucoma filtration surgical model of fibrosis.

PubMed

Bargagna-Mohan, Paola; Deokule, Sunil P; Thompson, Kyle; Wizeman, John; Srinivasan, Cidambi; Vooturi, Sunil; Kompella, Uday B; Mohan, Royce

2013-01-01

Withaferin A (WFA) is a natural product that binds to soluble forms of the type III intermediate filament (IF) vimentin. Currently, it is unknown under what pathophysiological contexts vimentin is druggable, as cytoskeltal vimentin-IFs are abundantly expressed. To investigate druggability of vimentin, we exploited rabbit Tenon's capsule fibroblast (RbTCF) cell cultures and the rabbit glaucoma filtration surgical (GFS) model of fibrosis. WFA potently caused G₀/G₁ cell cycle inhibition (IC₅₀ 25 nM) in RbTCFs, downregulating ubiquitin E3 ligase skp2 and inducing p27(Kip1) expression. Transforming growth factor (TGF)-ß-induced myofibroblast transformation caused development of cell spheroids with numerous elongated invadopodia, which WFA blocked potently by downregulating soluble vimentin and α-smooth muscle actin (SMA) expression. In the pilot proof-of-concept study using the GFS model, subconjunctival injections of a low WFA dose reduced skp2 expression in Tenon's capsule and increased p27(Kip1) expression without significant alteration to vimentin-IFs. This treatment maintains significant nanomolar WFA concentrations in anterior segment tissues that correspond to WFA's cell cycle targeting activity. A ten-fold higher WFA dose caused potent downregulation of soluble vimentin and skp2 expression, but as found in cell cultures, no further increase in p27(Kip1) expression was observed. Instead, this high WFA dose potently induced vimentin-IF disruption and downregulated α-SMA expression that mimicked WFA activity in TGF-ß-treated RbTCFs that blocked cell contractile activity at submicromolar concentrations. These findings illuminate that localized WFA injection to ocular tissues exerts pharmacological control over the skp2-p27(Kip1) pathway by targeting of soluble vimentin in a model of surgical fibrosis.

Exercise Among Women With Ovarian Cancer: A Feasibility and Pre-/Post-Test Exploratory Pilot Study.

PubMed

Zhang, Xiaochen; McClean, Daniel; Ko, Emily; Morgan, Mark A; Schmitz, Kathryn

2017-05-01

To establish the feasibility and acceptability of completing a higher dose of the planned physical activity volume among women with ovarian cancer, including those undergoing active treatment. 
. A pre-/post-test exercise intervention. All participants were asked to complete 225 minutes per week of physical activity for 26 weeks. Multiple supports were provided, including exercise DVDs, self-reported logs, and an objective physical activity tracker (Fitbit®).
. Home-based exercise intervention with in-person training and telephone follow-ups.
. 10 women with ovarian cancer who were treated within Penn Medicine in Philadelphia, Pennsylvania.
. Home-based, in-person exercise counseling was provided by an exercise trainer weekly for the first six weeks and then monthly for a total of 26 weeks. Weekly follow-up telephone calls were used to assess exercise adherence and barriers to completing exercise, review symptom changes, and provide behavioral support. 
. Feasibility and acceptability.
. Eight participants completed the study and achieved at least 80% of the prescribed exercise dose. Five participants were undergoing chemotherapy simultaneously. Participants experienced no adverse events during the 26-week intervention. Compared to baseline, average steps increased by 1,593 per day and moderate-intensity physical activity increased by 15 minutes per day. 
. A 225-minutes-per-week exercise program is feasible and acceptable in a population of patients with ovarian cancer. Participants significantly improved their physical activity during the 26-week intervention.
. The findings suggest that nursing professionals could recommend that women with ovarian cancer exercise 225 minutes per week regardless of cancer and/or treatment trajectory. For those experiencing aches and pains, behavioral supports and suggestions of a lower exercise dose are needed to maintain physical activity.

Comparison of Prasugrel and Ticagrelor Antiplatelet Effects in Korean Patients Presenting With ST-Segment Elevation Myocardial Infarction.

PubMed

Lee, Young Seok; Jin, Cai De; Kim, Moo Hyun; Guo, Long Zhe; Cho, Young-Rak; Park, Kyungil; Park, Jong Sung; Park, Tae-Ho; Kim, Young Dae

2015-01-01

There is insufficient data on the efficacy of prasugrel and ticagrelor in Korean patients with ST-segment elevation myocardial infarction (STEMI). I n the current double-blind, prospective pilot study, 39 patients with STEMI undergoing primary percutaneous coronary intervention were randomized to receive prasugrel 60 mg loading dose (LD) followed by 10 mg daily maintenance dose (n=19), or ticagrelor 180 mg LD followed by 90 mg twice daily maintenance dose (n=20). We assessed platelet reactivity with the VerifyNow and Vasodilator-Stimulated Phosphoprotein (VASP) P2Y12 assays. Compared to baseline platelet reactivity, both prasugrel and ticagrelor groups achieved similar and significantly lower P2Y12 reaction units (PRU) (259 [IQR: 230 to 281] vs. 28 [12 to 55] for prasugrel; 261 [196 to 286] vs. 43 [11 to 61] for ticagrelor), and platelet reactivity indexes (PRI) (51.2% [39.3 to 61.3] vs. 8.1% [6.1 to 14.7] for prasugrel; 47.5% [38.4 to 50.4] vs. 11.2% [7.1 to 15.5] for ticagrelor, all P values <0.001) at 48 h post-LD. Most patients had low platelet reactivity with 95% PRU values <85 and 82% with PRI <16%. Both prasugrel and ticagrelor were effective for platelet inhibition in Korean STEMI patients with almost no patients exhibiting high platelet reactivity at 48 h after the LD. Our finding of a high number of patients with very low platelet reactivity deserves further studies to assess the safety of the drugs (Prasugrel and Ticagrelor in ST-segment Elevation Myocardial Infarction Study, NCT02075125).

White Matter Integrity in High-Altitude Pilots Exposed to Hypobaria

PubMed Central

McGuire, Stephen A.; Boone, Goldie R.E.; Sherman, Paul M.; Tate, David F.; Wood, Joe D.; Patel, Beenish; Eskandar, George; Wijtenburg, S. Andrea; Rowland, Laura M.; Clarke, Geoffrey D.; Grogan, Patrick M.; Sladky, John H.; Kochunov, Peter V.

2017-01-01

Introduction Nonhypoxic hypobaric (low atmospheric pressure) occupational exposure, such as experienced by U.S. Air Force U-2 pilots and safety personnel operating inside altitude chambers, is associated with increased subcortical white matter hyperintensity (WMH) burden. The pathophysiological mechanisms underlying this discrete WMH change remain unknown. The objectives of this study were to demonstrate that occupational exposure to nonhypoxic hypobaria is associated with altered white matter integrity as quantified by fractional anisotropy (FA) measured using diffusion tensor imaging and relate these findings to WMH burden and neurocognitive ability. Methods There were 102 U-2 pilots and 114 age- and gender-controlled, health-matched controls who underwent magnetic resonance imaging. All pilots performed neurocognitive assessment. Whole-brain and tract-wise average FA values were compared between pilots and controls, followed by comparison within pilots separated into high and low WMH burden groups. Neurocognitive measurements were used to help interpret group difference in FA values. Results Pilots had significantly lower average FA values than controls (0.489/0.500, respectively). Regionally, pilots had higher FA values in the fronto-occipital tract where FA values positively correlated with visual-spatial performance scores (0.603/0.586, respectively). There was a trend for high burden pilots to have lower FA values than low burden pilots. Discussion Nonhypoxic hypobaric exposure is associated with significantly lower average FA in young, healthy U-2 pilots. This suggests that recurrent hypobaric exposure causes diffuse axonal injury in addition to focal white matter changes. PMID:28323582

Assessing five pilot carbon trading programs in China from a perspective of efficiency analysis

NASA Astrophysics Data System (ADS)

Yu, Xianyu; Shi, Guo; Wang, Jinghan

2018-02-01

In order to overcome the challenge of growing carbon emissions in China, the pilot carbon emissions trading systems (ETSs) serve as precursors of the national carbon ETS. Five province-level pilot ETSs in Beijing, Tianjin, Shanghai, Guangdong and Hubei are assessed from the view of carbon emission efficiency analysis in this study. Firstly, both the environmental production technology and the Malmquist index are adopted to evaluate the carbon emission efficiency of 28 provinces in China. Then, the regression significance analysis of carbon emission efficiency and the operational information evaluation for pilot ETSs are combined to develop an integrated approach for assessing five considered pilot ETSs. The Efficiency analysis of carbon emissions indicate that the effect of ETS in Beijing is significant, the effect of ETS in Tianjin is weak significant, and those of the other three pilot ETSs are not significant. Based on the operational information for pilot ETSs, the evaluating results of pilot ETSs in Beijing and Hubei are better than those of other pilot ETSs. This study highlights two main findings. First, the pilot ETS in Beijing has better performance than the other considered pilot ETSs, and its operational experience should be promoted throughout the country to improve the construction of national carbon ETS. Second, the successful cooperation between the ETSs in Beijing and Tianjin implies that the regional cooperation among neighbouring ETSs should be encouraged and further implemented to enhance the overall performance of the regional ETSs.

A Bayesian Dose-finding Design for Oncology Clinical Trials of Combinational Biological Agents

PubMed Central

Cai, Chunyan; Yuan, Ying; Ji, Yuan

2013-01-01

Treating patients with novel biological agents is becoming a leading trend in oncology. Unlike cytotoxic agents, for which efficacy and toxicity monotonically increase with dose, biological agents may exhibit non-monotonic patterns in their dose-response relationships. Using a trial with two biological agents as an example, we propose a dose-finding design to identify the biologically optimal dose combination (BODC), which is defined as the dose combination of the two agents with the highest efficacy and tolerable toxicity. A change-point model is used to reflect the fact that the dose-toxicity surface of the combinational agents may plateau at higher dose levels, and a flexible logistic model is proposed to accommodate the possible non-monotonic pattern for the dose-efficacy relationship. During the trial, we continuously update the posterior estimates of toxicity and efficacy and assign patients to the most appropriate dose combination. We propose a novel dose-finding algorithm to encourage sufficient exploration of untried dose combinations in the two-dimensional space. Extensive simulation studies show that the proposed design has desirable operating characteristics in identifying the BODC under various patterns of dose-toxicity and dose-efficacy relationships. PMID:24511160

Pilot Study on Folate Bioavailability from a Camembert Cheese Reveals Contradictory Findings to Recent Results from a Human Short-term Study.

PubMed

Mönch, Sabine; Netzel, Michael; Netzel, Gabriele; Ott, Undine; Frank, Thomas; Rychlik, Michael

2016-01-01

Different dietary sources of folate have differing bioavailabilities, which may affect their nutritional "value." In order to examine if these differences also occur within the same food products, a short-term human pilot study was undertaken as a follow-up study to a previously published human trial to evaluate the relative native folate bioavailabilities from low-fat Camembert cheese compared to pteroylmonoglutamic acid as the reference dose. Two healthy human subjects received the test foods in a randomized cross-over design separated by a 14-day equilibrium phase. Folate body pools were saturated with a pteroylmonoglutamic acid supplement before the first testing and between the testings. Folates in test foods and blood plasma were analyzed by stable isotope dilution assays. The biokinetic parameters C max, t max, and area under the curve (AUC) were determined in plasma within the interval of 0-12 h. When comparing the ratio estimates of AUC and C max for the different Camembert cheeses, a higher bioavailability was found for the low-fat Camembert assessed in the present study (≥64%) compared to a different brand in our previous investigation (8.8%). It is suggested that these differences may arise from the different folate distribution in the soft dough and firm rind as well as differing individual folate vitamer proportions. The results clearly underline the importance of the food matrix, even within the same type of food product, in terms of folate bioavailability. Moreover, our findings add to the increasing number of studies questioning the general assumption of 50% bioavailability as the rationale behind the definition of folate equivalents. However, more research is needed to better understand the interactions between individual folate vitamers and other food components and the potential impact on folate bioavailability and metabolism.

Pilot Study on Folate Bioavailability from a Camembert Cheese Reveals Contradictory Findings to Recent Results from a Human Short-term Study

PubMed Central

Mönch, Sabine; Netzel, Michael; Netzel, Gabriele; Ott, Undine; Frank, Thomas; Rychlik, Michael

2016-01-01

Different dietary sources of folate have differing bioavailabilities, which may affect their nutritional “value.” In order to examine if these differences also occur within the same food products, a short-term human pilot study was undertaken as a follow-up study to a previously published human trial to evaluate the relative native folate bioavailabilities from low-fat Camembert cheese compared to pteroylmonoglutamic acid as the reference dose. Two healthy human subjects received the test foods in a randomized cross-over design separated by a 14-day equilibrium phase. Folate body pools were saturated with a pteroylmonoglutamic acid supplement before the first testing and between the testings. Folates in test foods and blood plasma were analyzed by stable isotope dilution assays. The biokinetic parameters Cmax, tmax, and area under the curve (AUC) were determined in plasma within the interval of 0–12 h. When comparing the ratio estimates of AUC and Cmax for the different Camembert cheeses, a higher bioavailability was found for the low-fat Camembert assessed in the present study (≥64%) compared to a different brand in our previous investigation (8.8%). It is suggested that these differences may arise from the different folate distribution in the soft dough and firm rind as well as differing individual folate vitamer proportions. The results clearly underline the importance of the food matrix, even within the same type of food product, in terms of folate bioavailability. Moreover, our findings add to the increasing number of studies questioning the general assumption of 50% bioavailability as the rationale behind the definition of folate equivalents. However, more research is needed to better understand the interactions between individual folate vitamers and other food components and the potential impact on folate bioavailability and metabolism. PMID:27092303

Divalproex Sodium for the Treatment of PTSD and Conduct Disordered Youth: A Pilot Randomized Controlled Clinical Trial

ERIC Educational Resources Information Center

Steiner, Hans; Saxena, Kirti S.; Carrion, Victor; Khanzode, Leena A.; Silverman, Melissa; Chang, Kiki

2007-01-01

We examined the efficacy of divalproex sodium (DVP) for the treatment of PTSD in conduct disorder, utilizing a previous study in which 71 youth were enrolled in a randomized controlled clinical trial. Twelve had PTSD. Subjects (all males, mean age 16, SD 1.0) were randomized into high and low dose conditions. Clinical Global Impression (CGI)…

Discussion of "Polybrominated diphenyl ethers in aircraft cabins--a source of human exposure?" by Anna Christiansson et al. [Chemosphere 73(10) (2008) 1654-1660].

PubMed

Schecter, Arnold; Colacino, Justin; Haffner, Darrah; Patel, Keyur; Opel, Matthias; Päpke, Olaf

2010-01-01

This paper presents new data on the levels of polybrominated diphenyl ethers (PBDEs) in American airline workers. This pilot study did not find elevated total PBDEs in the blood of nine flight attendants and one aircraft pilot who have worked in airplanes for at least the past 5 years. These findings are not consistent with the findings of elevated blood levels of PBDEs from the 2008 Christiansson et al. publication "Polybrominated diphenyl ethers in aircraft cabins - A source of human exposure?" We agree that more research needs to be done on larger, more representative samples of airline workers to better characterize exposure of airline workers and other frequent flyers to PBDEs.

Brief report: Bereaved parents informing research design: The place of a pilot study.

PubMed

Donovan, L A; Wakefield, C E; Russell, V; Hetherington, Kate; Cohn, R J

2018-02-23

Risk minimization in research with bereaved parents is important. However, little is known about which research methods balance the sensitivity required for bereaved research participants and the need for generalizable results. To explore parental experiences of participating in mixed method bereavement research via a pilot study. A convergent parallel mixed method design assessing bereaved parents' experience of research participation. Eleven parents whose child was treated for cancer at The Royal Children's Hospital, Brisbane completed the questionnaire/interview being piloted (n = 8 mothers; n = 3 fathers; >6 months and <6 years bereaved). Of these, eight parents completed the pilot study evaluation questionnaire, providing feedback on their experience of participation. Participants acknowledged the importance of bereaved parents being central to research design and the development of bereavement programs. Sixty-three per cent (n = 5/8) of parents described completion of the questionnaire as 'not at all/a little bit' of a burden. Seventy-five per cent (n = 6/8) of parents opting into the telephone interview described participation as 'not at all/a little bit' of a burden. When considering the latest timeframes for participation in bereavement research 63% (n = 5/8) of parents indicated 'no endpoint.' Findings from the pilot study enabled important adjustments to be made to a large-scale future study. As a research method, pilot studies may be utilized to minimize harm and maximize the potential benefits for vulnerable research participants. A mixed method approach allows researchers to generalize findings to a broader population while also drawing on the depth of the lived experience.

Investigating gender differences under conditions of fatigue in a simulated high G aerial combat environment.

PubMed

Chelette, T L

1997-06-01

Advances in technology have equipped high-performance combat aircraft with the capability of delivering higher and higher sustained acceleration or G-forces on the pilots flying them. While the physiological effects of increased g-forces on the human body continue to be investigated, studies examining the effects of acceleration on the cognitive abilities of high-performance aircraft pilots remain sparse. Additionally, as higher technology is making its way into the cockpit, so are female pilots. With even fewer studies investigating women's physiological and cognitive tolerances to the stressors in the high-performance cockpit and flight environment, Dr. Chelette's study aimed to investigate these issues. Examining pilot workload, flight task abilities, and the effects of sleeplessness on both male and female pilots, Dr. Chelette's results revealed findings that will make their way into the high-performance cockpit of the future.

Reviewing and piloting methods for decreasing discount rates; someone, somewhere in time.

PubMed

Parouty, Mehraj B Y; Krooshof, Daan G M; Westra, Tjalke A; Pechlivanoglou, Petros; Postma, Maarten J

2013-08-01

There has been substantial debate on the need for decreasing discounting for monetary and health gains in economic evaluations. Next to the discussion on differential discounting, a way to identify the need for such discounting strategies is through eliciting the time preferences for monetary and health outcomes. In this article, the authors investigate the perceived time preference for money and health gains through a pilot survey on Dutch university students using methods on functional forms previously suggested. Formal objectives of the study were to review such existing methods and to pilot them on a convenience sample using a questionnaire designed for this specific purpose. Indeed, a negative relation between the time of delay and the variance of the discounting rate for all models was observed. This study was intended as a pilot for a large-scale population-based investigation using the findings from this pilot on wording of the questionnaire, interpretation, scope and analytic framework.

Magnitude of visual accommodation to a head-up display

NASA Technical Reports Server (NTRS)

Leitner, E. F.; Haines, R. F.

1981-01-01

The virtual image symbology of head-up displays (HUDs) is presented at optical infinity to the pilot. This design feature is intended to help pilots maintain visual focus distance at optical infinity. However, the accommodation response could be nearer than optical infinity, due to an individual's dark focus response. Accommodation responses were measured of two age groups of airline pilots to: (1) static symbology on a HUD; (2) a landing site background at optical infinity; (3) the combination of the HUD symbology and the landing site background; and (4) complete darkness. Results indicate that magnitude of accommodation to HUD symbology, with and without the background, is not significantly different from an infinity focus response for either age group. The dark focus response is significantly closer than optical infinity for the younger pilots, but not the older pilots, a finding consistent with previous research.

Physiological Indices of Pilots' Abilities Under Varying Task Demands.

PubMed

Wang, Zhen; Zheng, Lingxiao; Lu, Yanyu; Fu, Shan

2016-04-01

This study investigated pilots' ability by examining the effects of flight experience and task demand on physiological reactions, and analyzing the diagnostic meanings underlying correlated parameters. A total of 12 experienced pilots and 12 less experienced pilots performed 4 simulated flight tasks, including normal and emergency situations. Fixation duration (FD), saccade rate (SR), blink rate (BR), heart rate (HR), respiration rate (RR), and respiration amplitude (RA) were measured during the tasks. More experienced pilots adapted their SR flexibly to changing task demands and had significantly lower SR than less experienced pilots during emergency tasks (29.6 ± 20.0 vs. 70.1 ± 67.1 saccades/min). BR, HR, and RR were affected by pilot experience but not by task demand. More experienced pilots had lower BR, HR, and RR than less experienced pilots during both normal tasks (BR: 14.3 ± 13.0 vs. 32.9 ± 25.8 blinks/min; HR: 72.7 ± 7.9 vs. 83.2 ± 7.2 bpm; RR: 15.4 ± 2.1 vs. 19.5 ± 5.2 breaths/min) and emergency tasks (BR: 10.2 ± 5.0 vs. 32.3 ± 20.8 blinks/min; HR: 73.3 ± 7.3 vs. 82.2 ± 11.6 bpm; RR: 15.6 ± 1.9 vs. 18.0 ± 3.2 breaths/min). FD and RA were not sensitive to either flight experience or task demand. Physiological reactions have the potential to reflect pilots' ability from different aspects. SR and BR could indicate pilots' differences in information access strategy. HR and RR could reflect a pilot's physical fitness. These findings are useful for understanding a pilot's ability.

Thoughts in flight: automation use and pilots' task-related and task-unrelated thought.

PubMed

Casner, Stephen M; Schooler, Jonathan W

2014-05-01

The objective was to examine the relationship between cockpit automation use and task-related and task-unrelated thought among airline pilots. Studies find that cockpit automation can sometimes relieve pilots of tedious control tasks and afford them more time to think ahead. Paradoxically, automation has also been shown to lead to lesser awareness. These results prompt the question of what pilots think about while using automation. A total of 18 airline pilots flew a Boeing 747-400 simulator while we recorded which of two levels of automation they used. As they worked, pilots were verbally probed about what they were thinking. Pilots were asked to categorize their thoughts as pertaining to (a) a specific task at hand, (b) higher-level flight-related thoughts (e.g.,planning ahead), or (c) thoughts unrelated to the flight. Pilots' performance was also measured. Pilots reported a smaller percentage of task-at-hand thoughts (27% vs. 50%) and a greater percentage of higher-level flight-related thoughts (56% vs. 29%) when using the higher level of automation. However, when all was going according to plan, using either level of automation, pilots also reported a higher percentage of task-unrelated thoughts (21%) than they did when in the midst of an unsuccessful performance (7%). Task-unrelated thoughts peaked at 25% when pilots were not interacting with the automation. Although cockpit automation may provide pilots with more time to think, it may encourage pilots to reinvest only some of this mental free time in thinking flight-related thoughts. This research informs the design of human-automation systems that more meaningfully engage the human operator.

A rule-based, dose-finding design for use in stroke rehabilitation research: methodological development.

PubMed

Colucci, E; Clark, A; Lang, C E; Pomeroy, V M

2017-12-01

Dose-optimisation studies as precursors to clinical trials are rare in stroke rehabilitation. To develop a rule-based, dose-finding design for stroke rehabilitation research. 3+3 rule-based, dose-finding study. Dose escalation/de-escalation was undertaken according to preset rules and a mathematical sequence (modified Fibonacci sequence). The target starting daily dose was 50 repetitions for the first cohort. Adherence was recorded by an electronic counter. At the end of the 2-week training period, the adherence record indicated dose tolerability (adherence to target dose) and the outcome measure indicated dose benefit (10% increase in motor function). The preset increment/decrease and checking rules were then applied to set the dose for the subsequent cohort. The process was repeated until preset stopping rules were met. Participants had a mean age of 68 (range 48 to 81) years, and were a mean of 70 (range 9 to 289) months post stroke with moderate upper limb paresis. A custom-built model of exercise-based training to enhance ability to open the paretic hand. Repetitions per minute of extension/flexion of paretic digits against resistance. Usability of the preset rules and whether the maximally tolerated dose was identifiable. Five cohorts of three participants were involved. Discernibly different doses were set for each subsequent cohort (i.e. 50, 100, 167, 251 and 209 repetitions/day). The maximally tolerated dose for the model training task was 209 repetitions/day. This dose-finding design is a feasible method for use in stroke rehabilitation research. Copyright © 2017 Chartered Society of Physiotherapy. All rights reserved.

Effect of the Affordable Medicines Facility--malaria (AMFm) on the availability, price, and market share of quality-assured artemisinin-based combination therapies in seven countries: a before-and-after analysis of outlet survey data.

PubMed

Tougher, Sarah; Ye, Yazoume; Amuasi, John H; Kourgueni, Idrissa A; Thomson, Rebecca; Goodman, Catherine; Mann, Andrea G; Ren, Ruilin; Willey, Barbara A; Adegoke, Catherine A; Amin, Abdinasir; Ansong, Daniel; Bruxvoort, Katia; Diallo, Diadier A; Diap, Graciela; Festo, Charles; Johanes, Boniface; Juma, Elizabeth; Kalolella, Admirabilis; Malam, Oumarou; Mberu, Blessing; Ndiaye, Salif; Nguah, Samuel B; Seydou, Moctar; Taylor, Mark; Rueda, Sergio Torres; Wamukoya, Marilyn; Arnold, Fred; Hanson, Kara

2012-12-01

Malaria is one of the greatest causes of mortality worldwide. Use of the most effective treatments for malaria remains inadequate for those in need, and there is concern over the emergence of resistance to these treatments. In 2010, the Global Fund launched the Affordable Medicines Facility--malaria (AMFm), a series of national-scale pilot programmes designed to increase the access and use of quality-assured artemisinin based combination therapies (QAACTs) and reduce that of artemisinin monotherapies for treatment of malaria. AMFm involves manufacturer price negotiations, subsidies on the manufacturer price of each treatment purchased, and supporting interventions such as communications campaigns. We present findings on the effect of AMFm on QAACT price, availability, and market share, 6-15 months after the delivery of subsidised ACTs in Ghana, Kenya, Madagascar, Niger, Nigeria, Uganda, and Tanzania (including Zanzibar). We did nationally representative baseline and endpoint surveys of public and private sector outlets that stock antimalarial treatments. QAACTs were identified on the basis of the Global Fund's quality assurance policy. Changes in availability, price, and market share were assessed against specified success benchmarks for 1 year of AMFm implementation. Key informant interviews and document reviews recorded contextual factors and the implementation process. In all pilots except Niger and Madagascar, there were large increases in QAACT availability (25·8-51·9 percentage points), and market share (15·9-40·3 percentage points), driven mainly by changes in the private for-profit sector. Large falls in median price for QAACTs per adult equivalent dose were seen in the private for-profit sector in six pilots, ranging from US$1·28 to $4·82. The market share of oral artemisinin monotherapies decreased in Nigeria and Zanzibar, the two pilots where it was more than 5% at baseline. Subsidies combined with supporting interventions can be effective in rapidly improving availability, price, and market share of QAACTs, particularly in the private for-profit sector. Decisions about the future of AMFm should also consider the effect on use in vulnerable populations, access to malaria diagnostics, and cost-effectiveness. The Global Fund to Fight AIDS, Tuberculosis and Malaria, and the Bill & Melinda Gates Foundation. Copyright © 2012 Elsevier Ltd. All rights reserved.

Peracetic acid (PAA) disinfection of primary, secondary and tertiary treated municipal wastewaters.

PubMed

Koivunen, J; Heinonen-Tanski, H

2005-11-01

The efficiency of peracetic acid (PAA) disinfection against enteric bacteria and viruses in municipal wastewaters was studied in pilot-scale. Disinfection pilot-plant was fed with the primary or secondary effluent of Kuopio municipal wastewater treatment plant or tertiary effluent from the pilot-scale dissolved air flotation (DAF) unit. Disinfectant doses ranged from 2 to 7 mg/l PAA in the secondary and tertiary effluents, and from 5 to 15 mg/l PAA in the primary effluents. Disinfection contact times were 4-27 min. Disinfection of secondary and tertiary effluents with 2-7 mg/l PAA and 27 min contact time achieved around 3 log reductions of total coliforms (TC) and enterococci (EC). PAA disinfection also significantly improved the hygienic quality of the primary effluents: 10-15 mg/l PAA achieved 3-4 log reductions of TC and EC, 5 mg/l PAA resulting in below 2 log reductions. F-RNA coliphages were more resistant against the PAA disinfection and around 1 log reductions of these enteric viruses were typically achieved in the disinfection treatments of the primary, secondary and tertiary effluents. Most of the microbial reductions occurred during the first 4-18 min of contact time, depending on the PAA dose and microorganism. The PAA disinfection efficiency remained relatively constant in the secondary and tertiary effluents, despite of small changes of wastewater quality (COD, SS, turbidity, 253.7 nm transmittance) or temperature. The disinfection efficiency clearly decreased in the primary effluents with substantially higher microbial, organic matter and suspended solids concentrations. The results demonstrated that PAA could be a good alternative disinfection method for elimination of enteric microbes from different wastewaters.

Accelerated Titration of Oxytocin in Nulliparous Women with Labour Dystocia: Results of the ACTION Pilot Randomized Controlled Trial.

PubMed

Dy, Jessica; Rainey, Jenna; Walker, Mark C; Fraser, William; Smith, Graeme N; White, Ruth Rennicks; Waddell, Patti; Janoudi, Ghayath; Corsi, Daniel J; Wei, Shu Qin

2018-06-01

The primary objective was to determine the feasibility of a large RCT assessing the effectiveness of an accelerated oxytocin titration (AOT) protocol compared with a standard gradual oxytocin titration (GOT) in reducing the risk of CS in nulliparous women diagnosed with dystocia in the first stage of labour. The secondary objective was to obtain preliminary data on the safety and efficacy of the foregoing AOT protocol. This was a multicentre, double-masked, parallel-group pilot RCT. This study was conducted in three Canadian birthing centres. A total of 79 term nulliparous women carrying a singleton pregnancy in spontaneous labour, with a diagnosis of labour dystocia, were randomized to receive either GOT (initial dose 2 mU/min with increments of 2 mU/min) or AOT (initial dose 4 mU/min with increments of 4 mU/min), in a 1:1 ratio. An intention-to-treat analysis was applied. A total of 252 women were screened and approached, 137 (54.4%) consented, and 79 (31.3%) were randomized. Overall protocol adherence was 76 of 79 (96.2%). Of the women randomized, 10 (25.6%) allocated to GOT had a CS compared with six (15.0%) allocated to AOT (Fisher exact test P = 0.27). This pilot study demonstrated that a large, multicentre RCT is not only feasible, but also necessary to assess the effectiveness and safety of an AOT protocol for labour augmentation with regard to CS rate and indicators of maternal and perinatal morbidities. Copyright © 2018 Society of Obstetricians and Gynaecologists of Canada. Published by Elsevier Inc. All rights reserved.

A hybrid froth flotation-filtration system as a pretreatment for oil sands tailings pond recycle water management: Bench- and pilot-scale studies.

PubMed

Loganathan, Kavithaa; Bromley, David; Chelme-Ayala, Pamela; Gamal El-Din, Mohamed

2015-09-15

Through sustainable water management, oil sands companies are working to reduce their reliance on fresh water by minimizing the amount of water required for their operations and by recycling water from tailings ponds. This study was the first pilot-scale testing of a hybrid technology consisting of froth flotation combined with filtration through precoated submerged stainless steel membranes used to treat recycle water from an oil sands facility. The results indicated that the most important factor affecting the performance of the hybrid system was the influent water quality. Any rise in the levels of suspended solids or total organic carbon of the feed water resulted in changes of chemical consumption rates, flux rates, and operating cycle durations. The selections of chemical type and dosing rates were critical in achieving optimal performance. In particular, the froth application rate heavily affected the overall recovery of the hybrid system as well as the performance of the flotation process. Optimum surfactant usage to generate froth (per liter of treated water) was 0.25 mL/L at approximately 2000 NTU of influent turbidity and 0.015 mL/L at approximately 200 NTU of influent turbidity. At the tested conditions, the optimal coagulant dose was 80 mg/L (as Al) at approximately 2000 NTU of influent turbidity and <40 mg/L (as Al) at approximately 200 NTU of influent turbidity. Precoat loading per unit membrane surface area tested during the pilot study was approximately 30 g/m(2). The results of this study indicated that this hybrid technology can potentially be considered as a pre-treatment step for reverse osmosis treatment of recycle water. Copyright © 2015 Elsevier Ltd. All rights reserved.

Ultra-low-dose computed tomographic angiography with model-based iterative reconstruction compared with standard-dose imaging after endovascular aneurysm repair: a prospective pilot study.

PubMed

Naidu, Sailen G; Kriegshauser, J Scott; Paden, Robert G; He, Miao; Wu, Qing; Hara, Amy K

2014-12-01

An ultra-low-dose radiation protocol reconstructed with model-based iterative reconstruction was compared with our standard-dose protocol. This prospective study evaluated 20 men undergoing surveillance-enhanced computed tomography after endovascular aneurysm repair. All patients underwent standard-dose and ultra-low-dose venous phase imaging; images were compared after reconstruction with filtered back projection, adaptive statistical iterative reconstruction, and model-based iterative reconstruction. Objective measures of aortic contrast attenuation and image noise were averaged. Images were subjectively assessed (1 = worst, 5 = best) for diagnostic confidence, image noise, and vessel sharpness. Aneurysm sac diameter and endoleak detection were compared. Quantitative image noise was 26% less with ultra-low-dose model-based iterative reconstruction than with standard-dose adaptive statistical iterative reconstruction and 58% less than with ultra-low-dose adaptive statistical iterative reconstruction. Average subjective noise scores were not different between ultra-low-dose model-based iterative reconstruction and standard-dose adaptive statistical iterative reconstruction (3.8 vs. 4.0, P = .25). Subjective scores for diagnostic confidence were better with standard-dose adaptive statistical iterative reconstruction than with ultra-low-dose model-based iterative reconstruction (4.4 vs. 4.0, P = .002). Vessel sharpness was decreased with ultra-low-dose model-based iterative reconstruction compared with standard-dose adaptive statistical iterative reconstruction (3.3 vs. 4.1, P < .0001). Ultra-low-dose model-based iterative reconstruction and standard-dose adaptive statistical iterative reconstruction aneurysm sac diameters were not significantly different (4.9 vs. 4.9 cm); concordance for the presence of endoleak was 100% (P < .001). Compared with a standard-dose technique, an ultra-low-dose model-based iterative reconstruction protocol provides comparable image quality and diagnostic assessment at a 73% lower radiation dose.

A Preliminary Analysis of Keystroke Log Data from a Timed Writing Task. Research Report. ETS RR-12-23

ERIC Educational Resources Information Center

Almond, Russell; Deane, Paul; Quinlan, Thomas; Wagner, Michael; Sydorenko, Tetyana

2012-01-01

The Fall 2007 and Spring 2008 pilot tests for the "CBAL"™ Writing assessment included experimental keystroke logging capabilities. This report documents the approaches used to capture the keystroke logs and the algorithms used to process the outputs. It also includes some preliminary findings based on the pilot data. In particular, it…

A Pilot Intervention to Improve the Structural Quality of Exam Essay Writing in UK Undergraduate Psychology Students

ERIC Educational Resources Information Center

Connelly, Vincent; Dockrell, Julie E.; Barnett, Jo

2006-01-01

Psychology undergraduates need to produce good quality essays in order to succeed at university. Students find the transition to university writing difficult. Using a rubric, a profile of student weakness in psychology essay writing was described. The students were generally poor at the structural organisation of their essays. A pilot intervention…

Improving Dementia Health Literacy Using the FLOW Mnemonic: Pilot Findings from the Old SCHOOL Hip-Hop Program

ERIC Educational Resources Information Center

Noble, James M.; Hedmann, Monique G.; Williams, Olajide

2015-01-01

Background: Dementia health literacy is low among the public and likely poses a significant barrier to Alzheimer's disease (AD) symptom recognition and treatment, particularly among minority populations already facing higher AD burden. We evaluated the pilot phase of a novel AD health education program, Old SCHOOL (Seniors Can Have Optimal…

Is There a Causal Effect of High School Math on Labor Market Outcomes?

ERIC Educational Resources Information Center

Joensen, Juanna Schroter; Nielsen, Helena Skyt

2009-01-01

In this paper, we exploit a high school pilot scheme to identify the causal effect of advanced high school math on labor market outcomes. The pilot scheme reduced the costs of choosing advanced math because it allowed for a more flexible combination of math with other courses. We find clear evidence of a causal relationship between math and…

A Portrait of Non-Tenure-Track Faculty in Technical and Professional Communication: Results of a Pilot Study

ERIC Educational Resources Information Center

Meloncon, Lisa; England, Peter; Ilyasova, Alex

2016-01-01

We report the results of a pilot study that offers the field of technical and professional communication its first look at material working conditions of contingent faculty, such as course loads, compensation, and professional support. Findings include that contingent faculty are more enduring with stable full-time, multi-year contracts; they…

Need for Achievement, Curiosity and Sense of Control: Pilot Study for a Large-Scale Investigation.

ERIC Educational Resources Information Center

Greenberger, Ellen; Entwisle, Doris R.

The introduction reviews a number of findings and problems in the measurement of achievement motivation and raises some questions concerning the possible friction between motivation to achieve and curiosity. Subjects for the two pilot studies es were ninth graders of average (95-113) and high IQ (128 +) from a predominantly upper middle-class…

A Pilot Study of Service-Learning in a Spanish Heritage Speaker Course: Community Engagement, Identity, and Language in the Chicago Area

ERIC Educational Resources Information Center

Petrov, Lisa Amor

2013-01-01

This article presents research findings from a pilot study of the use of service-learning in an intermediate-high class ("Spanish Language and Culture for Heritage Speakers") in the fall semesters of 2010 and 2011. Students reported gains in the areas of communication skills, dispositional learning, language, identity formation, and…

Development of a Parenting Support Program to Prevent Abuse of Adolescents in South Africa: Findings from a Pilot Pre-Post Study

ERIC Educational Resources Information Center

Cluver, Lucie D.; Lachman, Jamie M.; Ward, Catherine L.; Gardner, Frances; Peterson, Tshiamo; Hutchings, Judy M.; Mikton, Christopher; Meinck, Franziska; Tsoanyane, Sibongile; Doubt, Jenny; Boyes, Mark; Redfern, Alice A.

2017-01-01

Purpose: Violence against children increases in adolescence, but there is a research and practice gap in research-supported child abuse prevention for the adolescent years. A pilot program for low-resource settings was developed in collaboration with nongovernmental organizations, government, and academics in South Africa, using research-supported…

Application of Adaptive DP-optimality to Design a Pilot Study for a Clotting Time Test for Enoxaparin.

PubMed

Gulati, Abhishek; Faed, James M; Isbister, Geoffrey K; Duffull, Stephen B

2015-10-01

Dosing of enoxaparin, like other anticoagulants, may result in bleeding following excessive doses and clot formation if the dose is too low. We recently showed that a factor Xa based clotting time test could potentially assess the effect of enoxaparin on the clotting system. However, the test did not perform well in subsequent individuals and effectiveness of an exogenous phospholipid, Actin FS, in reducing the variability in the clotting time was assessed. The aim of this work was to conduct an adaptive pilot study to determine the range of concentrations of Xa and Actin FS to take forward into a proof-of-concept study. A nonlinear parametric function was developed to describe the response surface over the factors of interest. An adaptive method was used to estimate the parameters using a D-optimal design criterion. In order to provide a reasonable probability of observing a success of the clotting time test, a P-optimal design criterion was incorporated using a loss function to describe the hybrid DP-optimality. The use of adaptive DP-optimality method resulted in an efficient estimation of model parameters using data from only 6 healthy volunteers. The use of response surface modelling identified a range of sets of Xa and Actin FS concentrations, any of which could be used for the proof-of-concept study. This study shows that parsimonious adaptive DP-optimal designs may provide both precise parameter estimates for response surface modelling as well as clinical confidence in the potential benefits of the study.

Empowerment of diabetic patients through mHealth technologies and education: development of a pilot self-management application

NASA Astrophysics Data System (ADS)

Gustin, G.; Macq, B.; Gruson, D.; Kieffer, S.

2017-11-01

Diabetes is a major, global and increasing condition that occurs when the insulin-glucagon regulatory mechanism is affected, leading to uncontrolled hyper- and hypoglycaemia events that may be life-threatening. However, it has been shown that through daily monitoring, appropriate patient-specific empowerment, lifestyle behavior of diabetics can be positively influenced and the associated and costly diabetes complications significantly reduced. As personal face-to-face coaching is costly and hard to scale, mobile applications and services have now become a key driver of mobile Health (mHealth) deployment, especially as a helpful way for self-management. Despite the huge mHealth market, a major limitation of many diabetes apps is that they do not use inputted data to help patients determine their daily insulin doses. On the other hand, the majority of existing insulin dose calculator apps provide no protection against - or even may actively contribute to - incorrect or inappropriate dose recommendations that put users at risk. Besides, there is clear evidence that lack of education on insulinotherapy and carbohydrate counting is associated with higher blood glucose variability with type 1 diabetes. Hence, there is a need for an accurate modelling of glucose-insulin dynamics together as well as providing adequate educational support. The aims of this paper are: a) to highlight the usefulness of mHealth technologies in chronic disease management; b) to describe and discuss the development of an insulin bolus calculator integrated into a pilot mHealth app; c) to underline the importance of diabetes self-management education.

[Low-dose rate brachytherapy with locally integrated beta emitters after internal urethrotomy. A pilot project using an animal model].

PubMed

Weidlich, P; Adam, C; Sroka, R; Lanzl, I; Assmann, W; Stief, C

2007-09-01

The treatment of urethral strictures represents an unsolved urological problem. The effect of a (32)P-coated urethral catheter in the sense of low-dose rate brachytherapy to modulate wound healing will be analyzed in an animal experiment. Unfortunately it is not possible to present any results because this is being studied for the first time and there are no experiences with low-dose rate brachytherapy and this form of application in the lower urinary tract. Furthermore the animal experiment will only start in the near future. Both decade-long experiences with radiotherapy to treat benign diseases and our own results of previous studies in otolaryngology and ophthalmology let us expect a significantly lower formation of urethral strictures after internal urethrotomy. This study will contribute to improving the treatment of urethral strictures as demanded in previous papers.

Air Traffic Controller Performance and Acceptability of Multiple UAS in a Simulated NAS Environment

NASA Technical Reports Server (NTRS)

Vu, Kim-Phuong L.; Strybel, Thomas; Chiappe, Dan; Morales, Greg; Battiste, Vernol; Shively, Robert Jay

2014-01-01

Previously, we showed that air traffic controllers (ATCos) rated UAS pilot verbal response latencies as acceptable when a 1.5 s delay was added to the UAS pilot responses, but a 5 s delay was rated as mostly unacceptable. In the present study we determined whether a 1.5 s added delay in the UAS pilots' verbal communications would affect ATCos interactions with UAS and other conventional aircraft when the number and speed of the UAS were manipulated. Eight radar-certified ATCos participated in this simulation. The ATCos managed a medium altitude sector containing arrival aircraft, en route aircraft, and one to four UAS. The UAS were conducting a surveillance mission and flew at either a "slow" or "fast" speed. We measured both UAS and conventional pilots' verbal communication latencies, and obtained ATCos' acceptability ratings for these latencies. Although the UAS pilot response latencies were longer than those of conventional pilots, the ATCos rated UAS pilot verbal communication latencies to be as acceptable as those of conventional pilots. Because the overall traffic load within the sector was held constant, ATCos only performed slightly worse when multiple UAS were in their sector compared to when only one UAS was in the sector. Implications of these findings for UAS integration in the NAS are discussed.

Pilot Domain Task Experience in Night Fatal Helicopter Emergency Medical Service Accidents.

PubMed

Aherne, Bryan B; Zhang, Chrystal; Newman, David G

2016-06-01

In the United States, accident and fatality rates in helicopter emergency medical service (HEMS) operations increase significantly under nighttime environmentally hazardous operational conditions. Other studies have found pilots' total flight hours unrelated to HEMS accident outcomes. Many factors affect pilots' decision making, including their experience. This study seeks to investigate whether pilot domain task experience (DTE) in HEMS plays a role against likelihood of accidents at night when hazardous operational conditions are entered. There were 32 flights with single pilot nighttime fatal HEMS accidents between 1995 and 2013 with findings of controlled flight into terrain (CFIT) and loss of control (LCTRL) due to spatial disorientation (SD) identified. The HEMS DTE of the pilots were compared with industry survey data. Of the pilots, 56% had ≤2 yr of HEMS experience and 9% had >10 yr of HEMS experience. There were 21 (66%) accidents that occurred in non-visual flight rules (VFR) conditions despite all flights being required to be conducted under VFR. There was a statistically significant increase in accident rates in pilots with <2 and <4 yr HEMS DTE and a statistically significant decrease in accident rates in pilots with >10 yr HEMS DTE. HEMS DTE plays a preventive role against the likelihood of a night operational accident. Pilots with limited HEMS DTE are more likely to make a poor assessment of hazardous conditions at night, and this will place HEMS flight crew at high risk in the VFR night domain.

Case studies of energy efficiency financing in the original five pilot states, 1993-1996

DOE Office of Scientific and Technical Information (OSTI.GOV)

Farhar, B C; Collins, N E; Walsh, R W

1997-05-01

The purpose of this report is to document progress in state-level programs in energy efficiency financing programs that are linked with home energy rating systems. Case studies are presented of programs in five states using a federal pilot program to amortize the costs of home energy improvements. The case studies present background information, describe the states` program, list preliminary evaluation data and findings, and discuss problems and solution encountered in the programs. A comparison of experiences in pilot states will be used to provide guidelines for program implementers, federal agencies, and Congress. 5 refs.

Weight and Balance for the Airmass Incorporated Sunburst Model C Ultralight

NASA Technical Reports Server (NTRS)

1983-01-01

The results of the weight and balance determination done for an ultralight aircraft are presented. The weight and balance determination encompassed finding weight and center of gravity of each component, determining the center of gravity of the ultralight in an X, Y, Z reference plane, and calculating the mass moments and products of inertia. The relations were calculated for various pilot weights and fuel loadings. The fuel varied from empty to five gallons (31.05 lbs), and the pilots ranged from 90 to 260 pounds. The weighings of components total 277.48 lbs (no pilot and no fuel).

Higher landing accuracy in expert pilots is associated with lower activity in the caudate nucleus.

PubMed

Adamson, Maheen M; Taylor, Joy L; Heraldez, Daniel; Khorasani, Allen; Noda, Art; Hernandez, Beatriz; Yesavage, Jerome A

2014-01-01

The most common lethal accidents in General Aviation are caused by improperly executed landing approaches in which a pilot descends below the minimum safe altitude without proper visual references. To understand how expertise might reduce such erroneous decision-making, we examined relevant neural processes in pilots performing a simulated landing approach inside a functional MRI scanner. Pilots (aged 20-66) were asked to "fly" a series of simulated "cockpit view" instrument landing scenarios in an MRI scanner. The scenarios were either high risk (heavy fog-legally unsafe to land) or low risk (medium fog-legally safe to land). Pilots with one of two levels of expertise participated: Moderate Expertise (Instrument Flight Rules pilots, n = 8) or High Expertise (Certified Instrument Flight Instructors or Air-Transport Pilots, n = 12). High Expertise pilots were more accurate than Moderate Expertise pilots in making a "land" versus "do not land" decision (CFII: d' = 3.62 ± 2.52; IFR: d' = 0.98 ± 1.04; p<.01). Brain activity in bilateral caudate nucleus was examined for main effects of expertise during a "land" versus "do not land" decision with the no-decision control condition modeled as baseline. In making landing decisions, High Expertise pilots showed lower activation in the bilateral caudate nucleus (0.97 ± 0.80) compared to Moderate Expertise pilots (1.91 ± 1.16) (p<.05). These findings provide evidence for increased "neural efficiency" in High Expertise pilots relative to Moderate Expertise pilots. During an instrument approach the pilot is engaged in detailed examination of flight instruments while monitoring certain visual references for making landing decisions. The caudate nucleus regulates saccade eye control of gaze, the brain area where the "expertise" effect was observed. These data provide evidence that performing "real world" aviation tasks in an fMRI provide objective data regarding the relative expertise of pilots and brain regions involved in it.

Long-chain omega-3 fatty acids in aneurysmal subarachnoid hemorrhage: A randomized pilot trial of pharmaconutrition.

PubMed

Saito, Geisi; Zapata, Rodrigo; Rivera, Rodrigo; Zambrano, Héctor; Rojas, David; Acevedo, Hernán; Ravera, Franco; Mosquera, John; Vásquez, Juan E; Mura, Jorge

2017-01-01

Functional recovery after aneurysmal subarachnoid hemorrhage (SAH) remains a significant problem. We tested a novel therapeutic approach with long-chain omega-3 polyunsaturated fatty acids (n-3 PUFAs) to assess the safety and feasibility of an effectiveness trial. We conducted a multicentre, parallel, randomized, open-label pilot trial. Patients admitted within 72 hours after SAH with modified Fisher scale scores of 3 or 4 who were selected for scheduled aneurysm clipping were allocated to receive either n-3 PUFA treatment (parenteral perioperative: 5 days; oral: 8 weeks) plus usual care or usual care alone. Exploratory outcome measures included major postoperative intracranial bleeding complications (PIBCs), cerebral infarction caused by delayed cerebral ischemia, shunt-dependent hydrocephalus, and consent rate. The computed tomography evaluator was blinded to the group assignment. Forty-one patients were randomized, but one patient had to be excluded after allocation. Twenty patients remained for intention to treat analysis in each trial arm. No PIBs (95% confidence interval [CI]: 0.00 to 0.16) or other unexpected harm were observed in the intervention group (IG). No patient suspended the intervention due to side effects. There was a trend towards improvements in all benefit-related outcomes in the IG. The overall consent rate was 0.91 (95% CI: 0.78 to 0.96), and there was no consent withdrawal. Although the balance between the benefit and harm of the intervention appears highly favourable, further testing on SAH patients is required. We recommend proceeding with amendments in a dose-finding trial to determine the optimal duration of parenteral treatment.

HPV vaccination: Pilot study assessing characteristics of high and low performing primary care offices.

PubMed

Lollier, Allison; Rodriguez, Elisa M; Saad-Harfouche, Frances G; Widman, Christy A; Mahoney, Martin C

2018-06-01

This pilot study was undertaken to identify characteristics and approaches (e.g., social, behavioral, and/or systems factors) which differentiate primary care medical offices achieving higher rates of HPV vaccination. Eligible primary care practice sites providing care to adolescent patients were recruited within an eight county region of western New York State between June 2016 and July 2016. Practice sites were categorized as higher (n = 3) or lower performing (n = 2) based on three dose series completion rates for HPV vaccinations among females aged 13-17 years. Interviewer administered surveys were completed with office staff (n = 37) and focused on understanding approaches to adolescent vaccination. Results were summarized using basic descriptive statistics. Higher performing offices reported more full-time clinical staff (median = 25 vs. 9.5 in lower performing clinics), larger panels of patients ages 11-17 years (median = 3541 vs. 925) and completion of NYSIIS data entry within two weeks of vaccination. (less than a month vs. two). Staff in higher performing offices reviewed medical charts prior to scheduled visits (100% vs. 50) and identified their office vaccine champion as a physician and/or a nurse manager (75% vs. 22%). Also, staffs from higher performing offices were more likely to report the combination of having an office vaccine champion, previewing charts and using standing orders. These preliminary findings support future research examining implementation of organizational processes including identifying a vaccine champion, using standing orders and previewing medical charts prior to office visits as strategies to increase rates of HPV vaccination in primary care offices.

Modeling Immunization To Infliximab in Children With Crohn's Disease Using Population Pharmacokinetics: A Pilot Study.

PubMed

Petitcollin, Antoine; Leuret, Oriane; Tron, Camille; Lemaitre, Florian; Verdier, Marie-Clémence; Paintaud, Gilles; Bouguen, Guillaume; Willot, Stéphanie; Bellissant, Eric; Ternant, David

2018-05-18

Antidrug antibodies (ADAs) dramatically increase infliximab clearance and are responsible for underexposure to the drug, leading to treatment failure. This pilot study aimed at developing a population pharmacokinetic model to detect and describe an early increase in infliximab clearance due to ADA. Twenty children with Crohn's disease (CD) were followed for 1 year or until treatment failure. Infliximab trough concentration, ADA, C-reactive protein (CRP), and Paediatric Crohn's Disease Activity Index (PCDAI) were recorded at each visit. A time-varying clearance population pharmacokinetic model was built to detect and describe an increase in infliximab clearance, independent from ADA testing. Factors associated with clearance variation and the relationships between infliximab concentrations, clearance variation, and clinical response were investigated. The model detected important increases in clearance in 4 patients. These patients had suboptimal early response, with higher mean PCDAI (P = 0.0086) and CRP (P = 0.028) compared with other patients. Two of them had detectable ADA. Clearance increase as described by the model and lower infliximab trough concentration at week 2 were associated with poorer outcomes in a multivariate Cox model (P = 0.001 and P = 0.0048, respectively). Being able to detect an increase in infliximab clearance, this model could allow the early detection of immunization to infliximab and therefore could help with dose adjustment in patients with CD. Moreover, the results suggest that clearance variations could be used as a predictive marker of clinical response. These findings need to be confirmed in a larger cohort, however, and predictive factors of clearance increase have to be investigated.

Increase in PAS-induced neuroplasticity after a treatment course of intranasal ketamine for depression. Report of three cases from a placebo-controlled trial.

PubMed

Gálvez, Verònica; Nikolin, Stevan; Ho, Kerrie-Anne; Alonzo, Angelo; Somogyi, Andrew A; Loo, Colleen K

2017-02-01

Animal studies suggest that neural plasticity may play a role in the antidepressant effects of a single ketamine dose. However, the potential effects of repeated ketamine treatments on human neuroplasticity are unknown. This pilot RCT study measured plasticity-induced changes before and after a ketamine course, in three treatment-resistant depressed subjects, who were randomized to receive 8 intranasal treatments of 100mg ketamine or 4.5mg midazolam. Mood ratings were performed by a trained blinded rater at baseline and 24h-48h after the ketamine course, using the Montgomery Asberg Depression Rating Scale (MADRS). Neuroplasticity was assessed in the motor cortex using a paired associative stimulation (PAS) paradigm at baseline and 24h-48h after the treatment course. No changes in current psychotropic medication or dosage were permitted for 4weeks prior to trial entry and throughout the trial. The subject receiving ketamine, but not those receiving midazolam, presented a marked increase in neural plasticity after the treatment course. However, mood changes were not associated with changes in neural plasticity. Pilot study with small sample size. Concomitant antidepressant medications taken. Plasticity was tested in the motor cortex only, thus the generalizability of these findings to other brain areas cannot be assumed. These results suggest that a course of intranasal ketamine may enhance synaptic plasticity in subjects with depression, but this was not associated with antidepressant effects. Further research on this topic is warranted. Copyright © 2016 Elsevier Inc. All rights reserved.

Plasma metabolomics in adults with cystic fibrosis during a pulmonary exacerbation: a pilot randomized study of high-dose vitamin D3 administration

PubMed Central

Alvarez, Jessica A.; Chong, Elizabeth Y.; Walker, Douglas I.; Chandler, Joshua D.; Michalski, Ellen S.; Grossmann, Ruth E.; Uppal, Karan; Li, Shuzhao; Frediani, Jennifer K.; Tirouvanziam, Rabindra; Tran, ViLinh T.; Tangpricha, Vin; Jones, Dean P.; Ziegler, Thomas R.

2017-01-01

Background Cystic fibrosis (CF) is a chronic catabolic disease often requiring hospitalization for acute episodes of worsening pulmonary exacerbations. Limited data suggest that vitamin D may have beneficial clinical effects, but the impact of vitamin D on systemic metabolism in this setting is unknown. Objective We used high-resolution metabolomics (HRM) to assess the impact of baseline vitamin D status and high-dose vitamin D3 administration on systemic metabolism in adults with CF with an acute pulmonary exacerbation. Design Twenty-five hospitalized adults with CF were enrolled in a randomized trial of high-dose vitamin D3 (250,000 IU vitamin D3 bolus) versus placebo. Age-matched healthy subjects served as a reference group for baseline comparisons. Plasma was analyzed with liquid chromatography/ultra-high resolution mass spectrometry. Using recent HRM bioinformatics and metabolic pathway enrichment methods, we examined associations with baseline vitamin D status (sufficient vs deficient per serum 25-hydroxyvitamin D concentrations) and the 7-day response to vitamin D3 supplementation. Results Several amino acids and lipid metabolites differed between CF and healthy control subjects, indicative of an overall catabolic state. In CF subjects, 343 metabolites differed (P<0.05) by baseline vitamin D status and were enriched within 7 metabolic pathways including fatty acid, amino acid, and carbohydrate metabolism. A total of 316 metabolites, which showed enrichment for 15 metabolic pathways--predominantly representing amino acid pathways-- differed between the vitamin D3- and placebo-treated CF subjects over time (P<0.05). In the placebo group, several tricarboxylic acid cycle intermediates increased while several amino acid-related metabolites decreased; in contrast, little change in these metabolites occurred with vitamin D3 treatment. Conclusions Numerous metabolic pathways detected by HRM varied in association with vitamin D status and high-dose vitamin D3 supplementation in adults with CF experiencing a pulmonary exacerbation. Overall, these pilot data suggest an anti-catabolic effect of high-dose vitamin D3 in this clinical setting. PMID:28403943

Novel System for Testing Dermal and Epidermal Toxicity in Vitro

DTIC Science & Technology

1990-02-15

of sodium dodecyl sulfate (SDS) were performed to set standard dose curves. The following procedure resulted frcm this pilot study: MODIFIED TOTAL...Detergent Association (SDA), commercial shampoos and household agents. These results were reproducible and could be correlated, in general, with in vivo...Detergents 2. Common household products and shampoos 3. Alcohols Page 24 4. Petrochemicals 5. Preservatives The substrate was also adapted for use in

Studies of Pilot Control During Launching and Reentry of Space Vehicles, Utilizing the Human Centrifuge

NASA Technical Reports Server (NTRS)

Clark, Carl C.; Woodling, C. H.

1959-01-01

With the ever increasing complexity of airplanes and the nearness to reality of manned space vehicles the use of pilot-controlled flight simulators has become imperative. The state of the art in flight simulation has progressed well with the demand. Pilot-controlled flight simulators are finding increasing uses in aeromedical research, airplane and airplane systems design, and preflight training. At the present many flight simulators are in existence with various degrees of sophistication and sundry purposes. These vary from fixed base simulators where the pilot applies control inputs according to visual cues presented to him on an instrument display to moving base simulators where various combinations of angular and linear motions are added in an attempt to improve the flight simulation.

Bioeconomic analysis of child-targeted subsidies for artemisinin combination therapies: a cost-effectiveness analysis

PubMed Central

Klein, Eili Y.; Smith, David L.; Cohen, Justin M.; Laxminarayan, Ramanan

2015-01-01

The Affordable Medicines Facility for malaria (AMFm) was conceived as a global market-based mechanism to increase access to effective malaria treatment and prolong effectiveness of artemisinin. Although results from a pilot implementation suggested that the subsidy was effective in increasing access to high-quality artemisinin combination therapies (ACTs), the Global Fund has converted AMFm into a country-driven mechanism whereby individual countries could choose to fund the subsidy from within their country envelopes. Because the initial costs of the subsidy in the pilot countries was higher than expected, countries are also exploring alternatives to a universal subsidy, such as subsidizing only child doses. We examined the incremental cost-effectiveness of a child-targeted policy using an age-structured bioeconomic model of malaria from the provider perspective. Because the vast majority of malaria deaths occur in children, targeting children could potentially improve the cost-effectiveness of the subsidy, though it would avert significantly fewer deaths. However, the benefits of a child-targeted subsidy (i.e. deaths averted) are eroded as leakage (i.e. older individuals taking young child-targeted doses) increases, with few of the benefits of a universal subsidy gained (i.e. reductions in overall prevalence). Although potentially more cost-effective, a child-targeted subsidy must contain measures to reduce the possibility of leakage. PMID:25994293

Dual modality imaging of a novel rat model of ovarian carcinogenesis

NASA Astrophysics Data System (ADS)

Kanter, Elizabeth; Walker, Ross; Marion, Sam; Brewer, Molly A.; Hoyer, Patricia B.; Barton, Jennifer K.

2006-07-01

Ovarian cancer is the fifth leading cause of cancer death in women, in part because of the limited knowledge about early stage disease. We develop a novel rat model of ovarian cancer and perform a pilot study to examine the harvested ovaries with complementary optical imaging modalities. Rats are exposed to repeated daily dosing (20 days) with 4-vinylcyclohexene diepoxide (VCD) to cause early ovarian failure (model for postmenopause), and ovaries are directly exposed to 7,12-dimethylbenz(a)anthracene (DMBA) to cause abnormal ovarian proliferation and neoplasia. Harvested ovaries are examined with optical coherence tomography (OCT) and light-induced fluorescence (LIF) at one, three, and five months post-DMBA treatment. VCD causes complete ovarian follicle depletion within 8 months after onset of dosing. DMBA induces abnormal size, cysts, and neoplastic changes. OCT successfully visualizes normal and abnormal structures (e.g., cysts, bursa, follicular remnant degeneration) and the LIF spectra show statistically significant changes in the ratio of average emission intensity at 390:450 nm between VCD-treated ovaries and both normal cycling and neoplastic DMBA-treated ovaries. Overall, this pilot study demonstrates the feasibility of both the novel animal model for ovarian cancer and the ability of optical imaging techniques to visualize ovarian function and health.

Factors that determine the optimum dose for sub-20nm resist systems: DUV, EUV, and e-beam options

NASA Astrophysics Data System (ADS)

Preil, Moshe

2012-03-01

As EUV and e-beam direct write (EBDW) technologies move closer to insertion into pilot production, questions regarding cost effectiveness take on increasing importance. One of the most critical questions is determining the optimum dose which balances the requirements for cost-effective throughput vs. imaging performance. To date most of the dose requirements have been dictated by the hardware side of the industry. The exposure tool manufacturers have a vested interest in specifying the fastest resists possible in order to maximize the throughput even if it comes at the expense of optimum resist performance. This is especially true for both EUV and EBDW where source power is severely limited. We will explore the cost-benefit tradeoffs which drive the equipment side of the industry, and show how these considerations lead to the current throughput and dose requirements for volume production tools. We will then show how the resulting low doses may lead to shot noise problems and a resulting penalty in resist performance. By comparison to the history of 248 nm DUV resist development we will illustrate how setting unrealistic initial targets for resist dose may lead to unacceptable tradeoffs in resist performance and subsequently long delays in the development of production worthy resists.

A flight investigation of simulated data-link communications during single-pilot IFR flight. Volume 2: Flight evaluations

NASA Technical Reports Server (NTRS)

Parker, J. F., Jr.; Duffy, J. W.

1982-01-01

Key problems in single pilot instrument flight operations are in the management of flight data and the processing of cockpit information during conditions of heavy workload. A flight data console was developed to allow simulation of a digital data link to replace the current voice communications stem used in air traffic control. This is a human factors evaluation of a data link communications system to determine how such a system might reduce cockpit workload, improve flight proficiency, and be accepted by general aviation pilots. The need for a voice channel as backup to a digital link is examined. The evaluations cover both airport terminal area operations and full mission instrument flight. Results show that general aviation pilots operate well with a digital data link communications system. The findings indicate that a data link system for pilot/ATC communications, with a backup voice channel, is well accepted by general aviation pilots and is considered to be safer, more efficient, and result in less workload than the current voice system.

Hyperintense white matter lesions in 50 high-altitude pilots with neurologic decompression sickness.

PubMed

McGuire, Stephen A; Sherman, Paul M; Brown, Anthony C; Robinson, Andrew Y; Tate, David F; Fox, Peter T; Kochunov, Peter V

2012-12-01

Neurologic decompression sickness (NDCS) can affect high-altitude pilots, causing variable central nervous system symptoms. Five recent severe episodes prompted further investigation. We report the hyperintense white matter (HWM) lesion imaging findings in 50 U-2 pilot volunteers, and compare 12 U-2 pilots who experienced clinical NDCS to 38 U-2 pilots who did not. The imaging data were collected using a 3T magnetic resonance imaging scanner and high-resolution (1-mm isotropic) three-dimensional fluid-attenuated inversion recovery sequence. Whole-brain and regional lesion volume and number were compared between groups. The NDCS group had significantly increased whole brain and insular volumes of HWM lesions. The intergroup difference in lesion numbers was not significant. A clinical episode of NDCS was associated with a significant increase in HWM lesion volume, especially in the insula. We postulate this to be due to hypobaric exposure rather than hypoxia since all pilots were maintained on 100% oxygen throughout the flight. Further studies will be necessary to better understand the pathophysiology underlying these lesions.

Hyperintense White Matter Lesions in 50 High-Altitude Pilots With Neurologic Decompression Sickness

PubMed Central

McGuire, Stephen A.; Sherman, Paul M.; Brown, Anthony C.; Robinson, Andrew Y.; Tate, David F.; Fox, Peter T.; Kochunov, Peter V.

2013-01-01

Introduction Neurologic decompression sickness (NDCS) can affect high-altitude pilots, causing variable central nervous system symptoms. Five recent severe episodes prompted further investigation. Methods We report the hyperintense white matter (HWM) lesion imaging findings in 50 U-2 pilot volunteers, and compare 12 U-2 pilots who experienced clinical NDCS to 38 U-2 pilots who did not. The imaging data were collected using a 3T magnetic resonance imaging scanner and high-resolution (1-mm isotropic) three-dimensional fluid-attenuated inversion recovery sequence. Whole-brain and regional lesion volume and number were compared between groups. Results The NDCS group had significantly increased whole brain and insular volumes of HWM lesions. The intergroup difference in lesion numbers was not significant. Conclusion A clinical episode of NDCS was associated with a significant increase in HWM lesion volume, especially in the insula. We postulate this to be due to hypobaric exposure rather than hypoxia since all pilots were maintained on 100% oxygen throughout the flight. Further studies will be necessary to better understand the pathophysiology underlying these lesions. PMID:23316539

Oral ketamine for children with chronic pain: a pilot phase 1 study

PubMed Central

Bredlau, Amy-Lee; McDermott, Michael P.; Adams, Heather; Dworkin, Robert H; Venuto, Charles; Fisher, Susan; Dolan, James G; Korones, David N

2013-01-01

Objective To assess whether oral ketamine aids is is safe at higher dosages for sedating children and whether it may be an option for control of chronic pain in children. Study design A prospective study was performed on 12 children with chronic pain to identify the maximum tolerated dosage of oral ketamine. Participants were given 14 days of oral ketamine, three times daily, at dosages ranging from 0.25–1.5 mg/kg/dose. Participants were assessed for toxicity and for pain severity at baseline and on day 14 of treatment. Results Two participants, both treated at 1.5 mg/kg/dose, experienced dose-limiting toxicities (sedation and anorexia). One participant, treated at 1 mg/kg/dose, opted to stop ketamine treatment due to new pain on treatment. Nine participants completed their course of ketamine treatment. Of these 12 children, 5 experienced improvement in their pain scores, two with complete resolution of pain, lasting for more than 4 weeks off ketamine treatment. Conclusion Oral ketamine at dosages of 0.25–1 mg/kg/dose appears to be safe when given for 14 days to children with chronic pain. PMID:23403253

Development of phantom and methodology for 3D and 4D dose intercomparisons for advanced lung radiotherapy

NASA Astrophysics Data System (ADS)

Caloz, Misael; Kafrouni, Marilyne; Leturgie, Quentin; Corde, Stéphanie; Downes, Simon; Lehmann, Joerg; Thwaites, David

2015-01-01

There are few reported intercomparisons or audits of combinations of advanced radiotherapy methods, particularly for 4D treatments. As part of an evaluation of the implementation of advanced radiotherapy technology, a phantom and associated methods, initially developed for in-house commissioning and QA of 4D lung treatments, has been developed further with the aim of using it for end-to-end dose intercomparison of 4D treatment planning and delivery. The respiratory thorax phantom can house moving inserts with variable speed (breathing rate) and motion amplitude. In one set-up mode it contains a small ion chamber for point dose measurements, or alternatively it can hold strips of radiochromic film to measure dose distributions. Initial pilot and feasibility measurements have been carried out in one hospital to thoroughly test the methods and procedures before using it more widely across a range of hospitals and treatment systems. Overall, the results show good agreement between measured and calculated doses and distributions, supporting the use of the phantom and methodology for multi-centre intercomparisons. However, before wider use, refinements of the method and analysis are currently underway particularly for the film measurements.

High-Dose Selenium for the Mitigation of Radiation Injury: A Pilot Study in a Rat Model

PubMed Central

Sieber, Fritz; Muir, Sarah A.; Cohen, Eric P.; North, Paula E.; Fish, Brian L.; Irving, Amy A.; Mäder, Marylou; Moulder, John E.

2009-01-01

The purpose of this study was to evaluate in an animal model the safety and efficacy of dietary supplementation with high doses of selenium for the mitigation of the type of radiation injury that might be sustained during a nuclear accident or an act of radiological terrorism. Age-matched male rats were exposed to 10 Gy (single dose) of total-body irradiation (TBI) followed by a syngeneic bone marrow transplant, then randomized to standard drinking water or drinking water supplemented with sodium selenite or seleno-L-methionine. At 21 weeks after TBI, most rats on standard drinking water had severe renal failure with a mean blood urea nitrogen (BUN) level of 124 ± 29 mg/dl (geometric mean ± SE) whereas rats on selenium-supplemented drinking water (100 μg/day) had a mean BUN level of 67 ± 12 mg/dl. The mitigating effect of selenium was confirmed by histopathological analyses. None of the animals on high-dose selenium showed signs of selenium toxicity. Our results suggest that dietary supplementation with high-dose selenium may provide a safe, effective and practical way to mitigate radiation injury to kidneys. PMID:19267564

Substance P-induced skin inflammation is not modulated by a single dose of sitagliptin in human volunteers.

PubMed

Grouzmann, Eric; Bigliardi, Paul; Appenzeller, Monique; Pannatier, André; Buclin, Thierry

2011-03-01

Substance P (SP), an undecapeptide belonging to the tachykinin family, is released during the activation of sensory nerves, and causes vasodilation, edema and pain through activation of tissular Neurokinin 1 receptors. SP proinflammatory effects are terminated by angiotensin converting enzyme (ACE) and neutral endopeptidase (NEP), while the aminopeptidase dipeptidylpeptidase IV (DPPIV) can also play a role. The aim of this randomized, crossover, double-blind study was to assess the cutaneous vasoreactivity (flare and wheal reaction, burning pain sensation) to intradermal injection of ascending doses of SP in six volunteers receiving a single therapeutic dose of the DPPIV inhibitor sitagliptin or a matching placebo. Cutaneous SP challenges produced the expected, dose-dependent flare and wheal response, while eliciting mild to moderate local pain sensation with little dose dependency. However, no differences were shown in the responses observed under sitagliptin compared with placebo, while the study would have been sufficiently powered to detect a clinically relevant increase in sensitivity to SP. The results of this pilot study are in line with proteolytic cleavage of SP by ACE and NEP compensating the blockade of DPPIV to prevent an augmentation of its proinflammatory action.

Human papillomavirus vaccination coverage among females and males, National Health and Nutrition Examination Survey, United States, 2007-2016.

PubMed

Lewis, Rayleen M; Markowitz, Lauri E

2018-05-03

Human papillomavirus (HPV) vaccination has been routinely recommended at age 11-12 years in the United States for females since 2006 and males since 2011. Coverage can be estimated using self/parent-reported HPV vaccination collected in the National Health and Nutrition Examination Survey (NHANES) for a wider age range than other national surveys. We assessed vaccination coverage in 2015-2016, temporal trends by age, and the validity of self/parent-reported vaccination status. Participants aged 9-59 years completed an interview collecting demographic and vaccination information. Weighted coverage was estimated for two-year NHANES cycles by age group for 2007-2008 to 2015-2016 for females (N = 14318) and 2011-2012 to 2015-2016 for males (N = 7847). Temporal trends in coverage were assessed from 2007-2008 to 2011-2012 for females and from 2011-2012 to 2015-2016 for both sexes. Sensitivity and specificity of self/parent-reported vaccination were assessed using provider-verified vaccination records from a pilot study in 14-29 year-olds. In 2015-2016, ≥1 dose coverage among females was highest in 14-19 (54.7%) and 20-24 (56.0%) year-olds and lower in successively older age groups. Among males, ≥1 dose coverage was highest in 14-19 year-olds (39.5%) and lower at older ages. Coverage was similar in 9-13 year-old females and males. Between 2007-2008 and 2011-2012, there were increases among females younger than 30 years. Between 2011-2012 and 2015-2016, there were increases among female age groups including 20-39 year-olds; male coverage increased among ages 9-13, 14-19, and 20-24 years. Self/parent-reported receipt of ≥1 dose had a sensitivity and specificity of 87.0% and 83.3%. Performance was lower for 3 doses. While overall HPV vaccination coverage remains low, it is higher in females than males, except in 9-13 year-olds. There have been increases in coverage among many age groups, but coverage has stalled in younger females. Adequate validity was demonstrated for self/parent-reported vaccination of ≥1 dose, but not 3 doses, in a pilot study. Copyright © 2018 Elsevier Ltd. All rights reserved.

Whole-body biodistribution and brain PET imaging with [18F]AV-45, a novel amyloid imaging agent--a pilot study.

PubMed

Lin, Kun-Ju; Hsu, Wen-Chuin; Hsiao, Ing-Tsung; Wey, Shiaw-Pyng; Jin, Lee-Way; Skovronsky, Daniel; Wai, Yau-Yau; Chang, Hsiu-Ping; Lo, Chuan-Wei; Yao, Cheng Hsiang; Yen, Tzu-Chen; Kung, Mei-Ping

2010-05-01

The compound (E)-4-(2-(6-(2-(2-(2-(18)F-fluoroethoxy)ethoxy)ethoxy) pyridin-3-yl)vinyl)-N-methylbenzenamine ([(18)F]AV-45) is a novel radiopharmaceutical capable of selectively binding to beta-amyloid (A beta) plaques. This pilot study reports the safety, biodistribution, and radiation dosimetry of [(18)F]AV-45 in human subjects. In vitro autoradiography and fluorescent staining of postmortem brain tissue from patients with Alzheimer's disease (AD) and cognitively healthy subjects were performed to assess the specificity of the tracer. Biodistribution was assessed in three healthy elderly subjects (mean age: 60.0+/-5.2 years) who underwent 3-h whole-body positron emission tomography (PET)/computed tomographic (CT) scans after a bolus injection of 381.9+/-13.9 MBq of [(18)F]AV-45. Another six subjects (three AD patients and three healthy controls, mean age: 67.7+/-13.6 years) underwent brain PET studies. Source organs were delineated on PET/CT. All subjects underwent magnetic resonance imaging (MRI) for obtaining structural information. In vitro autoradiography revealed exquisitely high specific binding of [(18)F]AV-45 to postmortem AD brain sections, but not to the control sections. There were no serious adverse events throughout the study period. The peak uptake of the tracer in the brain was 5.12+/-0.41% of the injected dose. The highest absorbed organ dose was to the gallbladder wall (184.7+/-78.6 microGy/MBq, 4.8 h voiding interval). The effective dose equivalent and effective dose values for [(18)F]AV-45 were 33.8+/-3.4 microSv/MBq and 19.3+/-1.3 microSv/MBq, respectively. [(18)F]AV-45 binds specifically to A beta in vitro, and is a safe PET tracer for studying A beta distribution in human brain. The dosimetry is suitable for clinical and research application. (c) 2010 Elsevier Inc. All rights reserved.

Pharmacokinetics and Magnetic Resonance Imaging of Biodegradable Macromolecular Blood-Pool Contrast Agent PG-Gd in Non-Human Primates: A Pilot Study

PubMed Central

Tian, Mei; Wen, Xiaoxia; Jackson, Edward F.; Ng, Chaan; Uthamanthil, Rajesh; Liang, Dong; Gelovani, Juri G.; Li, Chun

2012-01-01

The purpose of this study was to evaluate poly(L-glutamic acid)-benzyl-DTPA-Gd (PG-Gd), a new biodegradable macromolecular magnetic resonance imaging contrast agent, for its pharmacokinetics and MRI enhancement in nonhuman primates. Studies were performed in rhesus monkeys at intravenous doses of 0.01, 0.02, and 0.08 mmol Gd/kg. T1-weighted MR images were acquired at 1.5T using fast spoiled gradient recalled echo and fast spin echo imaging protocols. The small-molecule contrast agent Magnevist was used as a control. PG-Gd in the monkey showed a bi-exponential disposition. The initial blood concentrations within 2 hours of PG-Gd administration were much higher than for those of Magnevist. The high blood concentration of PG-Gd was consistent with the MR imaging data, which showed prolonged circulation of PG-Gd in the blood pool. Enhancement of blood vessels and organs with a high blood perfusion (heart, liver, and kidney) was clearly visualized at 2 hours after contrast injection at the three doses used. A greater than proportional increase of the area under the blood concentration-time curve was observed when the administered single dose was increased from 0.01 mmol/kg to 0.08 mmol/kg. By 2 days after PG-Gd injection, the contrast agent was mostly cleared from all major organs, including kidney. The mean residence time was 15 hours at the 0.08 mmol/kg dose. A similar pharmacokinetic profile was observed in mice, with a mean residence time of 5.4 hours and a volume of distribution at steady-state of 85.5 mL/kg, indicating that the drug was mainly distributed in the blood compartment. Based on this pilot study, further investigations on potential systemic toxicity of PG-Gd in both rodents and large animals are needed before testing this agent in humans. PMID:21861289

Embracing model-based designs for dose-finding trials

PubMed Central

Love, Sharon B; Brown, Sarah; Weir, Christopher J; Harbron, Chris; Yap, Christina; Gaschler-Markefski, Birgit; Matcham, James; Caffrey, Louise; McKevitt, Christopher; Clive, Sally; Craddock, Charlie; Spicer, James; Cornelius, Victoria

2017-01-01

Background: Dose-finding trials are essential to drug development as they establish recommended doses for later-phase testing. We aim to motivate wider use of model-based designs for dose finding, such as the continual reassessment method (CRM). Methods: We carried out a literature review of dose-finding designs and conducted a survey to identify perceived barriers to their implementation. Results: We describe the benefits of model-based designs (flexibility, superior operating characteristics, extended scope), their current uptake, and existing resources. The most prominent barriers to implementation of a model-based design were lack of suitable training, chief investigators’ preference for algorithm-based designs (e.g., 3+3), and limited resources for study design before funding. We use a real-world example to illustrate how these barriers can be overcome. Conclusions: There is overwhelming evidence for the benefits of CRM. Many leading pharmaceutical companies routinely implement model-based designs. Our analysis identified barriers for academic statisticians and clinical academics in mirroring the progress industry has made in trial design. Unified support from funders, regulators, and journal editors could result in more accurate doses for later-phase testing, and increase the efficiency and success of clinical drug development. We give recommendations for increasing the uptake of model-based designs for dose-finding trials in academia. PMID:28664918

Diagnostic accuracy at several reduced radiation dose levels for CT imaging in the diagnosis of appendicitis

NASA Astrophysics Data System (ADS)

Zhang, Di; Khatonabadi, Maryam; Kim, Hyun; Jude, Matilda; Zaragoza, Edward; Lee, Margaret; Patel, Maitraya; Poon, Cheryce; Douek, Michael; Andrews-Tang, Denise; Doepke, Laura; McNitt-Gray, Shawn; Cagnon, Chris; DeMarco, John; McNitt-Gray, Michael

2012-03-01

Purpose: While several studies have investigated the tradeoffs between radiation dose and image quality (noise) in CT imaging, the purpose of this study was to take this analysis a step further by investigating the tradeoffs between patient radiation dose (including organ dose) and diagnostic accuracy in diagnosis of appendicitis using CT. Methods: This study was IRB approved and utilized data from 20 patients who underwent clinical CT exams for indications of appendicitis. Medical record review established true diagnosis of appendicitis, with 10 positives and 10 negatives. A validated software tool used raw projection data from each scan to create simulated images at lower dose levels (70%, 50%, 30%, 20% of original). An observer study was performed with 6 radiologists reviewing each case at each dose level in random order over several sessions. Readers assessed image quality and provided confidence in their diagnosis of appendicitis, each on a 5 point scale. Liver doses at each case and each dose level were estimated using Monte Carlo simulation based methods. Results: Overall diagnostic accuracy varies across dose levels: 92%, 93%, 91%, 90% and 90% across the 100%, 70%, 50%, 30% and 20% dose levels respectively. And it is 93%, 95%, 88%, 90% and 90% across the 13.5-22mGy, 9.6-13.5mGy, 6.4-9.6mGy, 4-6.4mGy, and 2-4mGy liver dose ranges respectively. Only 4 out of 600 observations were rated "unacceptable" for image quality. Conclusion: The results from this pilot study indicate that the diagnostic accuracy does not change dramatically even at significantly reduced radiation dose.

Removing guns from batterers: findings from a pilot survey of domestic violence restraining order recipients in California.

PubMed

Vittes, Katherine A; Webster, Daniel W; Frattaroli, Shannon; Claire, Barbara E; Wintemute, Garen J

2013-05-01

Persons under certain domestic violence restraining orders in California are required to surrender any firearms in their possession within 24 hours of service. The California Department of Justice funded a pilot program in which Sheriff's Offices in two counties developed a system for better enforcing the firearm surrender requirement. As part of a larger process evaluation, 17 restraining order recipients were interviewed about their experiences with and feelings about the removal of firearms from their abusers. Most women surveyed wanted firearms removed and felt safer as a result of their removal. Implications of the findings are discussed.

Ecological Assessment of Substance-abuse Experiences (EASE): findings from a new instrument development pilot study.

PubMed

Matto, Holly C; Miller, Keith; Spera, Christopher

2005-08-01

A newly developed instrument that assesses a client's orientation to addiction or recovery communities using social context referents was pilot tested with a sample of 103 adults seeking treatment for substance abuse at outpatient and residential treatment facilities on the East Coast. Preliminary findings show promising subscale reliabilities, and suggest that drug- and recovery-related social identities are related to drug-use severity and drug-use concern; and drug-related attitudinal congruence between the treatment-seeker and family and treatment-seeker and other significant persons are related to intention to make behavioral changes in reducing substance abuse.

Impact of social challenges on gaining employment for veterans with posttraumatic stress disorder: an exploratory moderator analysis.

PubMed

Davis, Lori L; Pilkinton, Patricia; Poddar, Swati; Blansett, Catherine; Toscano, Richard; Parker, Pamela E

2014-06-01

To explore whether psychosocial challenges impact effects of vocational rehabilitation in Veterans with Posttraumatic Stress Disorder (PTSD). A post hoc exploratory analysis of possible moderators of treatment was conducted on outcomes from a randomized, controlled trial of Individual Placement and Support in Veterans with PTSD. When examining groups within each moderator, there was a greater IPS supportive employment benefit in gaining competitive employment for those with inadequate transportation (number needed to treat [NNT] = 1.5) and inadequate housing (NNT = 1.5) compared with the main finding of the pilot study (NNT = 2.07). Compared with the main finding of the pilot study, there was no greater advantage of IPS for those with adequate transportation (NNT = 2.4) or adequate housing (NNT = 2.4). Compared with the main finding in the pilot study, those without a family care burden had a greater benefit from IPS (NNT = 1.4) and those with family care burden had a reduced treatment effect (NNT = 3.3). These results are exploratory and are not intended to guide clinical decision-making, but rather offer a potentially useful strategy in the design of larger trials of IPS.

Direct Measurement of Perchlorate Exposure Biomarkers in a Highly Exposed Population: A Pilot Study

PubMed Central

Wong, Michelle; Copan, Lori; Olmedo, Luis; Patton, Sharyle; Haas, Robert; Atencio, Ryan; Xu, Juhua; Valentin-Blasini, Liza

2011-01-01

Exposure to perchlorate is ubiquitous in the United States and has been found to be widespread in food and drinking water. People living in the lower Colorado River region may have perchlorate exposure because of perchlorate in ground water and locally-grown produce. Relatively high doses of perchlorate can inhibit iodine uptake and impair thyroid function, and thus could impair neurological development in utero. We examined human exposures to perchlorate in the Imperial Valley among individuals consuming locally grown produce and compared perchlorate exposure doses to state and federal reference doses. We collected 24-hour urine specimen from a convenience sample of 31 individuals and measured urinary excretion rates of perchlorate, thiocyanate, nitrate, and iodide. In addition, drinking water and local produce were also sampled for perchlorate. All but two of the water samples tested negative for perchlorate. Perchlorate levels in 79 produce samples ranged from non-detect to 1816 ppb. Estimated perchlorate doses ranged from 0.02 to 0.51 µg/kg of body weight/day. Perchlorate dose increased with the number of servings of dairy products consumed and with estimated perchlorate levels in produce consumed. The geometric mean perchlorate dose was 70% higher than for the NHANES reference population. Our sample of 31 Imperial Valley residents had higher perchlorate dose levels compared with national reference ranges. Although none of our exposure estimates exceeded the U. S. EPA reference dose, three participants exceeded the acceptable daily dose as defined by bench mark dose methods used by the California Office of Environmental Health Hazard Assessment. PMID:21394205

A Pilot Study: Cardiac Parameters in Children Receiving New-Generation Antidepressants.

PubMed

Uchida, Mai; Spencer, Andrea E; Kenworthy, Tara; Chan, James; Fitzgerald, Maura; Rosales, Ana Maria; Kagan, Elana; Saunders, Alexandra; Biederman, Joseph

2017-06-01

Because of concerns about potential associations between high doses of citalopram and QTc prolongation in adults, this study examined whether such associations are operant in children. We hypothesized that therapeutic doses of nontricyclic antidepressant medications (non-TCAs) prescribed to children would be cardiovascularly safe. The sample consisted of 49 psychiatrically referred children and adolescents 6 to 17 years old of both sexes treated with a non-TCA (citalopram, escitalopram, fluoxetine, paroxetine, sertraline, bupropion, duloxetine, venlafaxine, mirtazapine). To standardize the doses of different antidepressants, we converted doses of individual medicines into "citalopram equivalent doses" (CEDs) based on dosing recommendation for individual antidepressants. Correlation analysis was carried out to compare the continuous and weight-based CED to variables of interest. A QTc grouping was defined as normal, borderline, or abnormal, and CED was compared across QTc groupings using linear regression. An antidepressant dosage group was defined as low or high dose, and a t test compared variables of interest across dosage groups. No significant associations were found between total or weight-corrected CEDs of any antidepressant examined and QTc or any other electrocardiogram or blood pressure parameters. In patients taking citalopram or escitalopram, a significant correlation was found between PR interval and total daily dose, which disappeared when weight-based doses were used or when corrected by age. Although limited by a relatively small sample size, these results suggest that therapeutic doses of non-TCA antidepressants when used in children do not seem to be associated with prolonged QTc interval or other adverse cardiovascular effects.

A Pilot Study of Using Jazz Warm Up Exercises in Primary School Choir in Hong Kong

ERIC Educational Resources Information Center

Chen, Jason Chi Wai; Lee, Han Wai

2013-01-01

This pilot study is to examine whether it is valuable to implement jazz choral practice in Hong Kong primary school setting. The findings can serve as a reference to explore the possibilities of promoting jazz education in Asian countries or in China. The participants were 70 public primary school students from grade 2 to 5 in Hong Kong. All…

Reintegrating Children into the System of Substitute Care: Evaluation of the Exceptional Care Pilot Project

ERIC Educational Resources Information Center

Armour, Marilyn P.; Schwab, James

2005-01-01

This pilot study presents findings from a project to evaluate a program initiated by a state child welfare agency for its most hard-to-serve youth (N = 46). This emerging population is so dangerous and unmanageable that they are difficult, if not impossible, to place or treat. One state responded to this challenge by providing exceptional care…

The energy expenditure of helicopter pilots.

PubMed

Thornton, R; Brown, G A; Higenbottam, C

1984-08-01

The energy expenditure of Army Air Corps and Royal Air Force pilots has been measured during flight in Gazelle and Puma helicopters respectively. Heart rates were also recorded. The results were compared with resting values obtained in the crewroom before flight, and confirmed the findings of other authors that the energy cost of flying helicopters in level flight is about 50% higher than that of sitting at rest.

Developing Metacognitive and Discursive Activities in the Indonesian Mathematics Education. Results of a Feasibility Study

ERIC Educational Resources Information Center

Kaune, Christa; Cohors-Fresenborg, Elmar; Nowinska, Edyta; Marpaung, Yansen; Handayani, Novi

2012-01-01

This article reports on the findings of a German-Indonesian feasibility study, which has been conducted to examine whether a more extensive pilot study could be successful. The objective of the pilot study is to enhance the mathematical skills of Indonesian students in the 7th class by increasing the number of students who can really understand…

For the Record: The Lived Experience of Parents with a Learning Disability--A Pilot Study Examining the Scottish Perspective

ERIC Educational Resources Information Center

MacIntyre, Gillian; Stewart, Ailsa

2012-01-01

There are increasing numbers of parents with a learning disability living in the community although the exact numbers are unknown. Existing research suggests that this group of parents faces disadvantage and discrimination on a number of levels. This study reports on the findings of a small pilot study that examined the lived experience of five…

Forecasting Demand for Civilian Pilots: A Cost Savings Approach to Managing Air Force Pilot Resources

DTIC Science & Technology

2007-03-01

terror attacks led people to believe that flying was unsafe. The Breusch - Pagan /Cook-Weisberg test for heteroskedasticity was performed to find...would yield an increase of 13.8 million revenue passenger miles. As with the previous model, the Breusch - Pagan /Cook-Weisberg test for...Appendix A. Data Set of Variables Studied ............................................................ 31 Appendix B. Stationarity Tests

An Evaluation of the Teacher Learning Academy: Phases 1 and 2. Final Report (Summary Report and Full Report)

ERIC Educational Resources Information Center

Moor, Helen; Lamont, Emily; Lord, Pippa; Gulliver, Caroline

2006-01-01

This research sets out key findings from an evaluation of Phases 1 and 2 of the pilot Teacher Learning Academy (TLA). The pilot TLA was established by the General Teaching Council for England (GTC) to provide professional and public recognition for teacher learning and development work. The Academy offers the opportunity for the learning that…

Preparation and evaluation of unitary doses of propafenone used in children with supraventricular tachycardia: a pilot study.

PubMed

Flores Pérez, J; Ramírez Mendiola, B; Flores Pérez, C; García Álvarez, R; Juárez Olguín, H

2013-01-01

The aim was to prepare and evaluate unitary doses of propafenone (UDP) used in children with supraventricular tachycardia. UDP were prepared from four brands of tablets at doses of propafenone, 11, 25 and 90 mg, used in the Cardiology Service of this Institute. The stability of doses was determined at 20±5°C and 40°C for up to day 30. Besides, a weight variation test was performed. Plasma levels of propafenone were determined at steady state in 3 children diagnosed with supraventricular tachycardia under treatment with UDP. Concentrations of drug in blood were measured using a high pressure liquid chromatography method, previously validated. The stability of UDP, showed no significant statistical differences (p > 0.05) between doses or brands up to day 30, at both temperatures. The coefficient of variation from the weight variation was less than 6%. The plasma levels of propafenone at steady state were: patient 1, 31.57 ng/ml; patient 2, 226.46 ng/ml; and patient 3, 221.29 ng/ml. The actual administered dose for the patients could vary up to 6%, and doses prepared from different brands of tablets remain stables for up to day 30 at both temperatures. UDP is a temporal, safe and alternative option when pediatrics formulation of this drug is lacking.

Design and implementation of a film dosimetry audit tool for comparison of planned and delivered dose distributions in high dose rate (HDR) brachytherapy

NASA Astrophysics Data System (ADS)

Palmer, Antony L.; Lee, Chris; Ratcliffe, Ailsa J.; Bradley, David; Nisbet, Andrew

2013-10-01

A novel phantom is presented for ‘full system’ dosimetric audit comparing planned and delivered dose distributions in HDR gynaecological brachytherapy, using clinical treatment applicators. The brachytherapy applicator dosimetry test object consists of a near full-scatter water tank with applicator and film supports constructed of Solid Water, accommodating any typical cervix applicator. Film dosimeters are precisely held in four orthogonal planes bisecting the intrauterine tube, sampling dose distributions in the high risk clinical target volume, points A and B, bladder, rectum and sigmoid. The applicator position is fixed prior to CT scanning and through treatment planning and irradiation. The CT data is acquired with the applicator in a near clinical orientation to include applicator reconstruction in the system test. Gamma analysis is used to compare treatment planning system exported RTDose grid with measured multi-channel film dose maps. Results from two pilot audits are presented, using Ir-192 and Co-60 HDR sources, with a mean gamma passing rate of 98.6% using criteria of 3% local normalization and 3 mm distance to agreement (DTA). The mean DTA between prescribed dose and measured film dose at point A was 1.2 mm. The phantom was funded by IPEM and will be used for a UK national brachytherapy dosimetry audit.

Design and implementation of a film dosimetry audit tool for comparison of planned and delivered dose distributions in high dose rate (HDR) brachytherapy.

PubMed

Palmer, Antony L; Lee, Chris; Ratcliffe, Ailsa J; Bradley, David; Nisbet, Andrew

2013-10-07

A novel phantom is presented for 'full system' dosimetric audit comparing planned and delivered dose distributions in HDR gynaecological brachytherapy, using clinical treatment applicators. The brachytherapy applicator dosimetry test object consists of a near full-scatter water tank with applicator and film supports constructed of Solid Water, accommodating any typical cervix applicator. Film dosimeters are precisely held in four orthogonal planes bisecting the intrauterine tube, sampling dose distributions in the high risk clinical target volume, points A and B, bladder, rectum and sigmoid. The applicator position is fixed prior to CT scanning and through treatment planning and irradiation. The CT data is acquired with the applicator in a near clinical orientation to include applicator reconstruction in the system test. Gamma analysis is used to compare treatment planning system exported RTDose grid with measured multi-channel film dose maps. Results from two pilot audits are presented, using Ir-192 and Co-60 HDR sources, with a mean gamma passing rate of 98.6% using criteria of 3% local normalization and 3 mm distance to agreement (DTA). The mean DTA between prescribed dose and measured film dose at point A was 1.2 mm. The phantom was funded by IPEM and will be used for a UK national brachytherapy dosimetry audit.

The Effect of Ezetimibe/Statin Combination and High-Dose Statin Therapy on Thyroid Autoimmunity in Women with Hashimoto's Thyroiditis and Cardiovascular Disease: A Pilot Study.

PubMed

Krysiak, R; Szkróbka, W; Okopień, B

2016-10-01

Background: Intensive statin therapy was found to reduce thyroid autoimmunity in women with Hashimoto's thyroiditis. No similar data are available for other hypolipidemic agents. Methods: The participants of the study were 16 women with Hashimoto's thyroiditis and coronary artery disease. On the basis of statin tolerance, they were divided into 2 groups. 8 patients who did not tolerate high-dose statin therapy were treated with a statin, the dose of which was reduced by half, together with ezetimibe. The remaining 8 patients tolerating the treatment continued high-dose statin therapy. Plasma lipids, serum levels of thyrotropin, free thyroxine and free triiodothyronine, as well as titers of thyroid peroxidase and thyroglobulin antibodies were measured at the beginning of the study and 6 months later. Results: Replacing high-dose statin therapy with ezetimibe/statin combination therapy increased serum titers of thyroid peroxidase as well as led to an insignificant increase in serum titers of thyroglobulin antibodies. At the end of the study, thyroid peroxidase and thyroglobulin antibody titers were higher in patients receiving the combination therapy than in those treated only with high-dose statin. Conclusions: Our study shows that high-dose statin therapy produces a stronger effect on thyroid autoimmunity than ezetimibe/statin combination therapy. © Georg Thieme Verlag KG Stuttgart · New York.

Physiological Effects of Acceleration Observed During a Centrifuge Study of Pilot Performance

NASA Technical Reports Server (NTRS)

Smedal, Harald A.; Creer, Brent Y.; Wingrove, Rodney C.

1960-01-01

An investigation was conducted by the National Aeronautics and Space Administration, Ames Research Center, and the Naval Air Development Center, Aviation Medical Acceleration Laboratory, to study the effects of acceleration on pilot performance and to obtain some meaningful data for use in establishing tolerance to acceleration levels. The flight simulator used in the study was the Johnsville centrifuge operated as a closed loop system. The pilot was required to perform a control task in various sustained acceleration fields typical of those that Might be encountered by a pilot flying an entry vehicle in which he is seated in a forward-facing position. A special restraint system was developed and designed to increase the pilot's tolerance to these accelerations. The results of this study demonstrated that a well-trained subject, such as a test pilot, can adequately carry out a control task during moderately high accelerations for prolonged periods of time. The maximum levels of acceleration tolerated were approximately 6 times that of gravity for approximately 6 minutes, and varied slightly with the acceleration direction. The tolerance runs were in each case terminated by the subject. In all but two instances, the cause was extreme fatigue. On two occasions the subject terminated the run when he "grayed out." Although there were subjective and objective findings involving the visual and cardiovascular systems, the respiratory system yielded the more critical limiting factors. It would appear that these limiting factors were less severe during the "eyeballs-out" accelerations when compared with the "eyeballs-in" accelerations. These findings are explained on the basis of the influence that the inertial forces of acceleration have on the mechanics of respiration. A condensed version of this report was presented at the Annual Meeting of the Aerospace Medical Association, Miami Beach, May 5-11, 1960, in a paper entitled "Ability of Pilots to Perform a Control Task in Various Sustained Acceleration Fields."

The overall program effects of California's 3-Tier Assessment System pilot on crashes and mobility among senior drivers.

PubMed

Camp, Bayliss J

2013-12-01

In 2007, the California Department of Motor Vehicles (DMV) undertook a pilot study of the 3-Tier Assessment System, the purpose of which was to examine, in a large-scale real-time public agency setting, the effectiveness of this method for both reducing the crash risk of individual drivers and for extending the safe driving years of Californian drivers of all ages. The 3-Tier Assessment System consisted of tiered series of screening tools incorporated into the in-office driver's license renewal process. These screening tools identified drivers with various kinds of functional limitations (physical, visual, and cognitive/perceptual), that might impact safe driving. Paired with the screening tools were educational materials designed to improve drivers' knowledge of their own limitations, including compensating techniques. The present study is a population-based evaluation of the effects of the pilot on subsequent crash risk and mobility outcomes (including delicensure) of participating drivers age 70 and older. Pilot participants were compared with two control groups processed according to standard California DMV license renewal procedures. Because the 3-Tier Assessment System was designed to identify limitations normally associated with aging, the present analyses focus on drivers age 70 and older. However, it should be emphasized that during the 3-Tier pilot the screening tools were applied to drivers of all ages. There were two main findings. First, there were no consistent, statistically significant differences between the pilot and control groups in crash risk in the two years following screening. Second, pilot participants experienced statistically significant effects on mobility. These effects included delays in time to complete their license renewal, an increase in the number of assigned license restrictions, and an increase in the number of customers failing to renew their driving privilege. Based on these findings, suggestions for further research are made. None. © 2013.

Experiences with an adaptive design for a dose-finding study in patients with osteoarthritis.

PubMed

Miller, Frank; Björnsson, Marcus; Svensson, Ola; Karlsten, Rolf

2014-03-01

Dose-finding studies in non-oncology areas are usually conducted in Phase II of the development process of a new potential medicine and it is key to choose a good design for such a study, as the results will decide if and how to proceed to Phase III. The present article has focus on the design of a dose-finding study for pain in osteoarthritis patients treated with the TRPV1 antagonist AZD1386. We describe different design alternatives in the planning of this study, the reasoning for choosing the adaptive design and experiences with conduct and interim analysis. Three alternatives were proposed: one single dose-finding study with parallel design, a programme with a smaller Phase IIa study followed by a Phase IIb dose-finding study, and an adaptive dose-finding study. We describe these alternatives in detail and explain why the adaptive design was chosen for the study. We give insights in design aspects of the adaptive study, which need to be pre-planned, like interim decision criteria, statistical analysis method and setup of a Data Monitoring Committee. Based on the interim analysis it was recommended to stop the study for futility since AZD1386 showed no significant pain decrease based on the primary variable. We discuss results and experiences from the conduct of the study with the novel design approach. Huge cost savings have been done compared to if the option with one dose-finding design for Phase II had been chosen. However, we point out several challenges with this approach. Copyright © 2014 Elsevier Inc. All rights reserved.

High-dose ifosfamide by infusion with Mesna in advanced refractory sarcomas.

PubMed

Güllü, I; Yalçin, S; Tekuzman, G; Barişta, I; Alkiş, N; Celik, I; Zengin, N; Güler, N; Kars, A; Baltali, E

1996-01-01

Twenty patients with advanced sarcomas entered a pilot study with ifosfamide (IF) and mercaptoethane sulfonate sodium (Mesna) as a second-line treatment for six planned cycles. All patients had received prior doxorubicin- and cyclophosphamide-based chemotherapies. IF was administered at a dose of 3 g/m2 given as continuous intravenous infusion for 24 hr on day 1-5 with Mesna. In the absence of disease progression, chemotherapy was planned to be repeated every 4 weeks for six consecutive cycles. Following chemotherapy, only 2 patients (11%) achieved partial response with response durations of 6 and 9 months. There was no complete response. When considered for only high-grade tumors, the response rate reached up to 22%. Toxicity was reported for 48 cycles and the dose-limiting toxicities were myelosuppression (22%) and encephalopathy (17%). Chemotherapy protocol was changed after two or three courses in 16 patients with stable or progressive disease. IF/Mesna chemotherapy at this dose and schedule was not found to be very promising in refractory sarcomas as a second-line chemotherapy.

Dose dense cyclophosphamide, methotrexate, fluorouracil is feasible at 14-day intervals: a pilot study of every-14-day dosing as adjuvant therapy for breast cancer.

PubMed

Drullinsky, Pamela; Sugarman, Steven M; Fornier, Monica N; D'Andrea, Gabriella; Gilewski, Teresa; Lake, Diana; Traina, Tiffany; Wasserheit-Lieblich, Carolyn; Sklarin, Nancy; Atieh-Graham, Deena; Mills, Nancy; Troso-Sandoval, Tiffany; Seidman, Andrew D; Yuan, Jeffrey; Patel, Hamangi; Patil, Sujata; Norton, Larry; Hudis, Clifford

2010-12-01

Cyclophosphamide/methotrexate/fluorouracil (CMF) is a proven adjuvant option for patients with early-stage breast cancer. Randomized trials with other regimens demonstrate that dose-dense (DD) scheduling can offer greater efficacy. We investigated the feasibility of administering CMF using a DD schedule. Thirty-eight patients with early-stage breast cancer were accrued from March 2008 through June 2008. They were treated every 14 days with C 600, M 40, F 600 (all mg/m2) with PEG-filgrastim (Neulasta®) support on day 2 of each cycle. The primary endpoint was tolerability using a Simon's 2-stage optimal design. The design would effectively discriminate between true tolerability (as protocol-defined) rates of ≤ 60% and ≥ 80%. The median age was 52-years-old (range, 38-78 years of age). Twenty-nine of the 38 patients completed 8 cycles of CMF at 14-day intervals. Dose-dense adjuvant CMF is tolerable and feasible at 14-day intervals with PEG-filgrastim support.

Dose Titration Algorithm Tuning (DTAT) should supersede ‘the’ Maximum Tolerated Dose (MTD) in oncology dose-finding trials

PubMed Central

Norris, David C.

2017-01-01

Background. Absent adaptive, individualized dose-finding in early-phase oncology trials, subsequent ‘confirmatory’ Phase III trials risk suboptimal dosing, with resulting loss of statistical power and reduced probability of technical success for the investigational therapy. While progress has been made toward explicitly adaptive dose-finding and quantitative modeling of dose-response relationships, most such work continues to be organized around a concept of ‘the’ maximum tolerated dose (MTD). The purpose of this paper is to demonstrate concretely how the aim of early-phase trials might be conceived, not as ‘dose-finding’, but as dose titration algorithm (DTA)-finding. Methods. A Phase I dosing study is simulated, for a notional cytotoxic chemotherapy drug, with neutropenia constituting the critical dose-limiting toxicity. The drug’s population pharmacokinetics and myelosuppression dynamics are simulated using published parameter estimates for docetaxel. The amenability of this model to linearization is explored empirically. The properties of a simple DTA targeting neutrophil nadir of 500 cells/mm 3 using a Newton-Raphson heuristic are explored through simulation in 25 simulated study subjects. Results. Individual-level myelosuppression dynamics in the simulation model approximately linearize under simple transformations of neutrophil concentration and drug dose. The simulated dose titration exhibits largely satisfactory convergence, with great variance in individualized optimal dosing. Some titration courses exhibit overshooting. Conclusions. The large inter-individual variability in simulated optimal dosing underscores the need to replace ‘the’ MTD with an individualized concept of MTD i . To illustrate this principle, the simplest possible DTA capable of realizing such a concept is demonstrated. Qualitative phenomena observed in this demonstration support discussion of the notion of tuning such algorithms. Although here illustrated specifically in relation to cytotoxic chemotherapy, the DTAT principle appears similarly applicable to Phase I studies of cancer immunotherapy and molecularly targeted agents. PMID:28663782

A study of the effects of therapeutic doses of ionizing radiation in vitro on Lactobacillus isolates originating from the vagina - a pilot study.

PubMed

Gosiewski, Tomasz; Mróz, Tomasz; Ochońska, Dorota; Pabian, Wojciech; Bulanda, Malgorzata; Brzychczy-Wloch, Monika

2016-05-31

Ionizing radiation is used as a therapeutic option in the treatment of certain neoplastic lesions located, among others, in the pelvic region. The therapeutic doses of radiation employed often result in adverse effects manifesting themselves primarily in the form of genital tract infections in patients or diarrhea. The data available in the literature indicate disorders in the microbial ecosystem caused by ionizing radiation, which leads to the problems mentioned above. In the present study, we examined the influence of ionizing radiation on 52 selected strains of bacteria: Lactobacillus crispatus, L. fermentum, L. plantarum, L. reuteri, L. acidophilus L. amylovorus, L. casei, L. helveticus, L. paracasei, L. rhamnosus, L. salivarius and L. gasseri. This collection of Lactobacillus bacteria isolates of various species, obtained from the genital tract and gastrointestinal tract of healthy women, was tested for resistance to therapeutic doses of ionizing radiation. The species studied, were isolated from the genital tract (n = 30) and from the anus (n = 22) of healthy pregnant women. Three doses of 3 Gy (fractionated dose) and 50 Gy (total dose of the whole radiotherapy cycle) were applied. The greatest differences in survival of the tested strains in comparison to the control group (not subjected to radiation) were observed at the dose of 50 Gy. However, the results were not statistically significant. Survival decrease to zero was not demonstrated for any of the tested strains. Therapeutic doses of radiation do not affect the Lactobacillus bacteria significantly.

The impact of transition training on adapting to Technically Advanced Aircraft at regional airlines: Perceptions of pilots and instructor pilots

NASA Astrophysics Data System (ADS)

di Renzo, John Carl, Jr.

Scope and method of study. The purpose of this study was to test a hypothesis about pilot and instructor pilot perceptions of how effectively pilots learn and use new technology, found in Technically Advanced Aircraft (TAA), given initial type of instrumentation training. New aviation technologies such as Glass Cockpits in technically advanced aircraft are complex and can be difficult to learn and use. The research questions focused on the type of initial instrumentation training to determine the differences among pilots trained using various types of instrumentation ranging from aircraft equipped with traditional analog instrumentation to aircraft equipped with glass cockpits. A convenience sample of Pilots in Training (PT) and Instructor Pilots (IP) was selected from a regional airline. The research design used a mixed methodology. Pilots in training completed a thirty-two question quantitative questionnaire and instructor pilots completed a five question qualitative questionnaire. Findings and conclusions. This investigation failed to disprove the null hypothesis. The type of instrumentation training has no significant effect on newly trained regional airline pilot perceived ability to adapt to advanced technology cockpits. Therefore, no evidence exists from this investigation to support the early introduction and training of TAA. While the results of this investigation were surprising, they are nonetheless, instructive. Even though it would seem that there would be a relationship between exposure to and use of technically advanced instrumentation, apparently there was no perceived relationship for this group of airline transport pilots. However, a point of interest is that these pilots were almost evenly divided in their opinion of whether or not their previous training had prepared them for transition to TAA. The majority also believed that the type of initial instrumentation training received does make a difference when transitioning to TAA. Pilots believed that TAA made them safer pilots, but were not convinced it made them better pilots. The results of this investigation raise many new questions and provide a number of ideas for future research projects.

Optimization of the inter-tablet coating uniformity for an active coating process at lab and pilot scale.

PubMed

Just, Sarah; Toschkoff, Gregor; Funke, Adrian; Djuric, Dejan; Scharrer, Georg; Khinast, Johannes; Knop, Klaus; Kleinebudde, Peter

2013-11-30

The objective of this study was to enhance the inter-tablet coating uniformity in an active coating process at lab and pilot scale by statistical design of experiments. The API candesartan cilexetil was applied onto gastrointestinal therapeutic systems containing the API nifedipine to obtain fixed dose combinations of these two drugs with different release profiles. At lab scale, the parameters pan load, pan speed, spray rate and number of spray nozzles were examined. At pilot scale, the parameters pan load, pan speed, spray rate, spray time, and spray pressure were investigated. A low spray rate and a high pan speed improved the coating uniformity at both scales. The number of spray nozzles was identified as the most influential variable at lab scale. With four spray nozzles, the highest CV value was equal to 6.4%, compared to 13.4% obtained with two spray nozzles. The lowest CV of 4.5% obtained with two spray nozzles was further reduced to 2.3% when using four spray nozzles. At pilot scale, CV values between 2.7% and 11.1% were achieved. Since the test of uniformity of dosage units accepts CV values of up to 6.25%, this active coating process is well suited to comply with the pharmacopoeial requirements. Copyright © 2013 Elsevier B.V. All rights reserved.

Study of occupational stress among railway engine pilots

PubMed Central

Kumar, Devesh; Singh, Jai Vir; Kharwar, Poonam S.

2011-01-01

Background: Traffic volume and speed is going to be increased in Indian Railways successively, leading to higher stress in staff connected with train operations. The jobs of railway engine pilots come under the category of high-strain jobs, necessitating a need to conduct multicentric study to unfold the factors associated with occupational stress and organizational strategies. Materials and Methods: Present study covered 185 railway engine pilots and office clerks working in various railway zones by incidental method. Occupational Stress Index (OSI) test developed by Srivastva and Singh, questionnaire of specific stressors constructed by authors and laboratory test battery for psychological screening of high-speed train pilots were used as tools. Results: Means of OSI and all the 12 occupational stressors of railway engine pilots were found significantly higher to that of office clerks. Means of OSI and occupational stressors of goods train pilots were significantly higher in comparison to high-speed train pilots and passenger train pilots. Study revealed positive correlation of speed perception and complex reaction time tests and negative correlation of other constituent tests of laboratory test battery to OSI test. Highest subgroup of stressor observedwas role overload followed by role conflict. Conclusions: These findings provide a prima facie evidence of higher occupational stress among railway engine pilots because of identified specific stressors prevalent in their job and explore the possible intervention strategies for its reduction. Significant correlation is noticed between OSI and laboratory test results, indicating its relevant utility in preliminary psychological screening. PMID:21808497

Organizational pressures and mitigating strategies in small commercial aviation: findings from Alaska.

PubMed

Bearman, Chris; Paletz, Susannah B F; Orasanu, Judith; Brooks, Benjamin P

2009-12-01

Recent attention has focused on the way in which organizational factors can erode safety in aviation, particularly in regions that have a high accident rate, such as Alaska. The present study builds on this work by examining the direct and indirect pressures that can be exerted on pilots by Alaskan operators. In addition, the paper examines ways in which organizations and individuals manage the effects of pressure. Using the critical incident method to uncover situations where the pilot's skills had been challenged, 28 pilots who flew in Alaska were interviewed. A bottom-up qualitative analysis revealed a range of organizational pressures and mitigating strategies. Pilots in Alaska encountered both implicit and explicit norms and expectations to fly in marginal conditions. Pressure also arose from pilots' awareness of the need for their company to make money and from perceived job competition. Some Alaskan operators were able to mitigate the effects of pressure on their pilots and some pilots reported mitigating pressure to fly by managing their employer's expectations and re-emphasizing safety. Organizational factors were found to be an important source of pressure for pilots and are likely to contribute to the high accident rate in Alaska. Balancing the competing demands of safety and productivity may be extremely difficult for many small operators, which places a heavy reliance on the decision making of individuals. Both the subtle pressures on individual pilots and strategies for mitigating those pressures are, therefore, extremely important to safety and productivity in small-scale commercial aviation.

Let's talk about sex work in humanitarian settings: piloting a rights-based approach to working with refugee women selling sex in Kampala.

PubMed

Rosenberg, Jennifer S; Bakomeza, Denis

2017-11-01

Although it is well known that refugees engage in sex work as a form of livelihood, stigma and silence around this issue persist within humanitarian circles. As a result, these refugees' sexual and reproductive health and rights, and related vulnerabilities, remain overlooked. Their protection and health needs, which are significant, often go unmet at the field level. In 2016, the Women's Refugee Commission and Reproductive Health Uganda partnered to pilot a peer-education intervention tailored to meet the needs of refugee women engaged in sex work in Kampala. Findings from the pilot project suggest the feasibility of adapting existing rights-based and evidence-informed interventions with sex workers to humanitarian contexts. Findings further demonstrate how taking a community empowerment approach can facilitate these refugees' access to a range of critical information, services and support options - from information on how to use contraceptives, to referrals for friendly HIV testing and treatment, to peer counselling and protective peer networks.

Single- and Repeat-dose Oral Toxicity Studies of Lithospermum erythrorhizon Extract in Dogs

PubMed Central

Hwang, Jae-Sik; Kim, Myoung-Jun; Choi, Young Whan; Han, Kyoung-Goo; Kang, Jong-Koo

2015-01-01

Lithospermum erythrorhizon has long been used in traditional Asian medicine for the treatment of diseases, including skin cancer. The oral toxicity of a hexane extract of Lithospermum erythrorhizon root (LEH) was investigated in Beagle dogs by using single escalating doses, two-week dose range-finding, and 4-week oral repeat dosing. In the single dose-escalating oral toxicity study, no animal died, showed adverse clinical signs, or changes in body weight gain at LEH doses of up to 2,000 mg/kg. In a 2 week dose range-finding study, no treatment-related adverse effects were detected by urinalysis, hematology, blood biochemistry, organ weights, or gross and histopathological examinations at doses of up to 500 mg LEH/kg/day. In the 4 week repeat-dose toxicity study, a weight loss or decreased weight gain was observed at 300 mg/kg/day. Although levels of serum triglyceride and total bilirubin were increased in a dose dependent manner, there were no related morphological changes. Based on these findings, the sub-acute no observable adverse effect level for 4-week oral administration of LEH in Beagles was 100 mg/kg/day. PMID:25874036

Single- and Repeat-dose Oral Toxicity Studies of Lithospermum erythrorhizon Extract in Dogs.

PubMed

Nam, Chunja; Hwang, Jae-Sik; Kim, Myoung-Jun; Choi, Young Whan; Han, Kyoung-Goo; Kang, Jong-Koo

2015-03-01

Lithospermum erythrorhizon has long been used in traditional Asian medicine for the treatment of diseases, including skin cancer. The oral toxicity of a hexane extract of Lithospermum erythrorhizon root (LEH) was investigated in Beagle dogs by using single escalating doses, two-week dose range-finding, and 4-week oral repeat dosing. In the single dose-escalating oral toxicity study, no animal died, showed adverse clinical signs, or changes in body weight gain at LEH doses of up to 2,000 mg/kg. In a 2 week dose range-finding study, no treatment-related adverse effects were detected by urinalysis, hematology, blood biochemistry, organ weights, or gross and histopathological examinations at doses of up to 500 mg LEH/kg/day. In the 4 week repeat-dose toxicity study, a weight loss or decreased weight gain was observed at 300 mg/kg/day. Although levels of serum triglyceride and total bilirubin were increased in a dose dependent manner, there were no related morphological changes. Based on these findings, the sub-acute no observable adverse effect level for 4-week oral administration of LEH in Beagles was 100 mg/kg/day.

Prospective memory failures in aviation: effects of cue salience, workload, and individual differences.

PubMed

Van Benthem, Kathleen D; Herdman, Chris M; Tolton, Rani G; LeFevre, Jo-Anne

2015-04-01

Prospective memory allows people to complete intended tasks in the future. Prospective memory failures, such as pilots forgetting to inform pattern traffic of their locations, can have fatal consequences. The present research examined the impact of system factors (memory cue salience and workload) and individual differences (pilot age, cognitive health, and expertise) on prospective memory for communication tasks in the cockpit. Pilots (N = 101) flew a Cessna 172 simulator at a non-towered aerodrome while maintaining communication with traffic and attending to flight parameters. Memory cue salience (the prominence of cues that signal an intended action) and workload were manipulated. Prospective memory was measured as radio call completion rates. Pilots' prospective memory was adversely affected by low-salience cues and high workload. An interaction of cue salience, pilots' age, and cognitive health reflected the effects of system and individual difference factors on prospective memory failures. For example, younger pilots with low levels of cognitive health completed 78% of the radio calls associated with low-salience memory cues, whereas older pilots with low cognitive health scores completed just 61% of similar radio calls. Our findings suggest that technologies designed to signal intended future tasks should target those tasks with inherently low-salience memory cues. In addition, increasing the salience of memory cues is most likely to benefit pilots with lower levels of cognitive health in high-workload conditions.

The application of artificial intelligence techniques to large distributed networks

NASA Technical Reports Server (NTRS)

Dubyah, R.; Smith, T. R.; Star, J. L.

1985-01-01

Data accessibility and transfer of information, including the land resources information system pilot, are structured as large computer information networks. These pilot efforts include the reduction of the difficulty to find and use data, reducing processing costs, and minimize incompatibility between data sources. Artificial Intelligence (AI) techniques were suggested to achieve these goals. The applicability of certain AI techniques are explored in the context of distributed problem solving systems and the pilot land data system (PLDS). The topics discussed include: PLDS and its data processing requirements, expert systems and PLDS, distributed problem solving systems, AI problem solving paradigms, query processing, and distributed data bases.

Conducting pilot and feasibility studies.

PubMed

Cope, Diane G

2015-03-01

Planning a well-designed research study can be tedious and laborious work. However, this process is critical and ultimately can produce valid, reliable study findings. Designing a large-scale randomized, controlled trial (RCT)-the gold standard in quantitative research-can be even more challenging. Even the most well-planned study potentially can result in issues with research procedures and design, such as recruitment, retention, or methodology. One strategy that may facilitate sound study design is the completion of a pilot or feasibility study prior to the initiation of a larger-scale trial. This article will discuss pilot and feasibility studies, their advantages and disadvantages, and implications for oncology nursing research. 
.

Application of multi-enzymatic hydrolysis for improving the efficiency of the biogas production in solid waste fermentation process in Ostróda WWTP

NASA Astrophysics Data System (ADS)

Lipiński, Kamil; Umiejewska, Katarzyna

2017-11-01

Biomass fermentation is one of the important sources of renewable energy in EU. Application of multi-enzymatic hydrolysis process enables a significant increase in efficiency of biogas production. The main goal of the paper is to present the results of the pilot scale research performed in WWTP in óstroda. The fixed combination of three enzymes was continiously introduced: amylase, lipase and protease. Research aimed at verifying the impact of enzyme dose on sludge digestion process and on the amount of biogas produced. Statistical analysis of the research results allows to determine the influence of dosing the enzymes in mesophilic digestion on the biogas production.

Preliminary results for avelumab plus axitinib as first-line therapy in patients with advanced clear-cell renal-cell carcinoma (JAVELIN Renal 100): an open-label, dose-finding and dose-expansion, phase 1b trial.

PubMed

Choueiri, Toni K; Larkin, James; Oya, Mototsugu; Thistlethwaite, Fiona; Martignoni, Marcella; Nathan, Paul; Powles, Thomas; McDermott, David; Robbins, Paul B; Chism, David D; Cho, Daniel; Atkins, Michael B; Gordon, Michael S; Gupta, Sumati; Uemura, Hirotsugu; Tomita, Yoshihiko; Compagnoni, Anna; Fowst, Camilla; di Pietro, Alessandra; Rini, Brian I

2018-04-01

The combination of an immune checkpoint inhibitor and a VEGF pathway inhibitor to treat patients with advanced renal-cell carcinoma might increase the clinical benefit of these drugs compared with their use alone. Here, we report preliminary results for the combination of avelumab, an IgG1 monoclonal antibody against the programmed cell death protein ligand PD-L1, and axitinib, a VEGF receptor inhibitor approved for second-line treatment of advanced renal-cell carcinoma, in treatment-naive patients with advanced renal-cell carcinoma. The JAVELIN Renal 100 study is an ongoing open-label, multicentre, dose-finding, and dose-expansion, phase 1b study, done in 14 centres in the USA, UK, and Japan. Eligible patients were aged 18 years or older (≥20 years in Japan) and had histologically or cytologically confirmed advanced renal-cell carcinoma with clear-cell component, life expectancy of at least 3 months, an Eastern Cooperative Oncology Group performance status of 1 or less, received no previous systemic treatment for advanced renal cell carcinoma, and had a resected primary tumour. Patients enrolled into the dose-finding phase received 5 mg axitinib orally twice daily for 7 days, followed by combination therapy with 10 mg/kg avelumab intravenously every 2 weeks and 5 mg axitinib orally twice daily. Based on the pharmacokinetic data from the dose-finding phase, ten additional patients were enrolled into the dose-expansion phase and assigned to this regimen. The other patients in the dose-expansion phase started taking combination therapy directly. The primary endpoint was dose-limiting toxicities in the first 4 weeks (two cycles) of treatment with avelumab plus axitinib. Safety and antitumour activity analyses were done in all patients who received at least one dose of avelumab or axitinib. This trial is registered with ClinicalTrials.gov, number NCT02493751. Between Oct 30, 2015, and Sept 30, 2016, we enrolled six patients into the dose-finding phase and 49 into the dose-expansion phase of the study. One dose-limiting toxicity of grade 3 proteinuria due to axitinib was reported among the six patients treated during the dose-finding phase. At the cutoff date (April 13, 2017), six (100%, 95% CI 54-100) of six patients in the dose-finding phase and 26 (53%, 38-68) of 49 patients in the dose-expansion phase had confirmed objective responses (32 [58%, 44-71] of all 55 patients). 32 (58%) of 55 patients had grade 3 or worse treatment-related adverse events, the most frequent being hypertension in 16 (29%) patients and increased concentrations of alanine aminotransferase, amylase, and lipase, and palmar-plantar erythrodysaesthesia syndrome in four (7%) patients each. Six (11%) of 55 patients died before data cutoff, five (9%) due to disease progression and one (2%) due to treatment-related autoimmune myocarditis. At the end of the dose-finding phase, the maximum tolerated dose established for the combination was avelumab 10 mg/kg every 2 weeks and axitinib 5 mg twice daily. The safety profile of the combination avelumab plus axitinib in treatment-naive patients with advanced renal-cell carcinoma seemed to be manageable and consistent with that of each drug alone, and the preliminary data on antitumour activity are encouraging. A phase 3 trial is assessing avelumab and axitinib compared with sunitinib monotherapy. Pfizer and Merck. Copyright © 2018 Elsevier Ltd. All rights reserved.

An Overnight Success?: Usage Patterns and Demographics of Academic Library Patrons during the Overnight Period from 11 p.m.-8 a.m.

ERIC Educational Resources Information Center

Sanders, Mark; Hodges, Chris

2014-01-01

During the Fall 2013 semester East Carolina University's main library piloted 24/5 hours of operation by opening on Sunday morning and not closing until Friday night. This article details the planning and execution of the pilot program, as well the findings from the data collected during the overnight period by people-counting cameras and a…

Parental Influence on Children with Attention-Deficit/Hyperactivity Disorder: II. Results of a Pilot Intervention Training Parents as Friendship Coaches for Children

ERIC Educational Resources Information Center

Mikami, Amori Yee; Lerner, Matthew D.; Griggs, Marissa Swaim; McGrath, Alison; Calhoun, Casey D.

2010-01-01

We report findings from a pilot intervention that trained parents to be "friendship coaches" for their children with Attention-Deficit/Hyperactivity Disorder (ADHD). Parents of 62 children with ADHD (ages 6-10; 68% male) were randomly assigned to receive the parental friendship coaching (PFC) intervention, or to be in a no-treatment control group.…

Aeromedical Aspects of Findings from Aircraft-Assisted Pilot Suicides in the United States, 1993-2002

DTIC Science & Technology

2006-03-01

s us pe ct o f a rs on 10 - - - - - - U nd et er m in ed 11 Y - - - - - R es tra...assessment process. The most prevalent avenue for the treatment of depression is the use of Selective Serotonin Reuptake-Inhibitors ( SSRIs ...Aeromedical Aspects of Aircraft-Assisted Pilot Suicides in the United States, 1993-2002 7. Author( s ) 8. Performing Organization Report No. Johnson

A CBPR Partnership Increases HIV Testing among Men Who Have Sex with Men (MSM): Outcome Findings from a Pilot Test of the "CyBER/Testing" Internet Intervention

ERIC Educational Resources Information Center

Rhodes, Scott D.; Vissman, Aaron T.; Stowers, Jason; Miller, Cindy; McCoy, Thomas P.; Hergenrather, Kenneth C.; Wilkin, Aimee M.; Reece, Michael; Bachmann, Laura H.; Ore, Addison; Ross, Michael W.; Hendrix, Ellen; Eng, Eugenia

2011-01-01

The Internet has emerged as an important tool for the delivery of health promotion and disease prevention interventions. Our community-based participatory research (CBPR) partnership developed and piloted "CyBER/testing", a culturally congruent intervention designed to promote HIV testing among men who have sex with men (MSM) within existing…

Improving a web-based employability intervention for work-disabled employees: results of a pilot economic evaluation.

PubMed

Noben, Cindy; Evers, Silvia; Genabeek, Joost van; Nijhuis, Frans; de Rijk, Angelique

2017-04-01

Purpose The purpose of this study is to improve web-based employability interventions for employees with work-related health problems for both intervention content and study design by means of a pilot economic evaluation. Methods Uptake rate analysis for the intervention elements, cost effectiveness, cost utility and subgroup analyses were conducted to identify potential content-related intervention improvements. Differences in work ability and quality-adjusted life years and overall contribution of resource items to the total costs were assessed. These were used to guide study design improvements. Results Sixty-three participants were a-select allocated to either the intervention (n = 29) or the control (n = 34) group. Uptake regarding the intervention elements ranged between 3% and 70%. Cost-effectiveness and cost-utility analyses resulted in negative effects although higher total costs. Incremental effects were marginal (work ability -0.51; QALY -0.01). Conclusions The web-based tool to enhance employability among work disabled employees requires improvements regarding targeting and intensity; outcome measures selected and collection of cost data. With respect to the studies of disability and rehabilitation, the findings and methods presented in this pilot economic evaluation could guide the assessment of future assistive "e-health" technologies. IMPLICATIONS FOR REHABILITATION The methods presented in this pilot economic evaluation have large potentials to guide the assessment of future assistive e-health technologies addressing work-disabilities. The findings show that the web-based tool requires content related improvements with respect to targeting and intensity to enhance employability among work disabled employees. The findings show that the web-based tool would benefit from improvements related to the study design by more adequately selecting and collecting both outcome measures and cost data. The burden attributable to large-scale studies and implementation issues were prevented as the outcomes of the pilot economic evaluation did not support the implementation of the web-based tool.

The role of situation assessment and flight experience in pilots' decisions to continue visual flight rules flight into adverse weather.

PubMed

Wiegmann, Douglas A; Goh, Juliana; O'Hare, David

2002-01-01

Visual flight rules (VFR) flight into instrument meteorological conditions (IMC) is a major safety hazard in general aviation. In this study we examined pilots' decisions to continue or divert from a VFR flight into IMC during a dynamic simulation of a cross-country flight. Pilots encountered IMC either early or later into the flight, and the amount of time and distance pilots flew into the adverse weather prior to diverting was recorded. Results revealed that pilots who encountered the deteriorating weather earlier in the flight flew longer into the weather prior to diverting and had more optimistic estimates of weather conditions than did pilots who encountered the deteriorating weather later in the flight. Both the time and distance traveled into the weather prior to diverting were negatively correlated with pilots' previous flight experience. These findings suggest that VFR flight into IMC may be attributable, at least in part, to poor situation assessment and experience rather than to motivational judgment that induces risk-taking behavior as more time and effort are invested in a flight. Actual or potential applications of this research include the design of interventions that focus on improving weather evaluation skills in addition to addressing risk-taking attitudes.

The effects of workload on respiratory variables in simulated flight: a preliminary study.

PubMed

Karavidas, Maria Katsamanis; Lehrer, Paul M; Lu, Shou-En; Vaschillo, Evgeny; Vaschillo, Bronya; Cheng, Andrew

2010-04-01

In this pilot study, we investigated respiratory activity and end-tidal carbon dioxide (P(et)CO(2)) during exposure to varying levels of work load in a simulated flight environment. Seven pilots (age: 34-60) participated in a one-session test on the Boeing 737-800 simulator. Physiological data were collected while pilots wore an ambulatory multi-channel recording device. Respiratory variables, including inductance plethysmography (respiratory pattern) and pressure of end-tidal carbon dioxide (P(et)CO(2)), were collected demonstrating change in CO(2) levels proportional to changes in flight task workload. Pilots performed a set of simulation flight tasks. Pilot performance was rated for each task by a test pilot; and self-report of workload was taken using the NASA-TLX scale. Mixed model analysis revealed that respiration rate and minute ventilation are significantly associated with workload levels and evaluator scores controlling for "vanilla baseline" condition. Hypocapnia exclusively occurred in tasks where pilots performed more poorly. This study was designed as a preliminary investigation in order to develop a psychophysiological assessment methodology, rather than to offer conclusive findings. The results show that the respiratory system is very reactive to high workload conditions in aviation and suggest that hypocapnia may pose a flight safety risk under some circumstances. Copyright © 2010 Elsevier B.V. All rights reserved.

Use of a Data-Linked Weather Information Display and Effects on Pilot Navigation Decision Making in a Piloted Simulation Study

NASA Technical Reports Server (NTRS)

Yuchnovicz, Daniel E.; Novacek, Paul F.; Burgess, Malcolm A.; Heck, Michael L.; Stokes, Alan F.

2001-01-01

This study provides recommendations to the FAA and to prospective manufacturers based on an exploration of the effects of data link weather displays upon pilot decision performance. An experiment was conducted with twenty-four current instrument rated pilots who were divided into two equal groups and presented with a challenging but realistic flight scenario involving weather containing significant embedded convective activity. All flights were flown in a full-mission simulation facility within instrument meteorological conditions. The inflight weather display depicted NexRad images, graphical METARs and textual METARs. The objective was to investigate the potential for misuse of a weather display, and incorporate recommendations for the design and use of these displays. The primary conclusion of the study found that the inflight weather display did not improve weather avoidance decision making. Some of the reasons to support this finding include: the pilot's inability to easily perceive their proximity to the storms, increased workload and difficulty in deciphering METAR textual data. The compelling nature of a graphical weather display caused many pilots to reduce their reliance on corroborating weather information from other sources. Minor changes to the weather display could improve the ability of a pilot to make better decisions on hazard avoidance.

The Effects of Atropine Sulfate on Aviator Performance

DTIC Science & Technology

1989-09-01

Bozzetti, L. P. (1976). Simulated flying performance after marihuana intoxication. Aviation, Space, and Environmental Medicine , 47(2), 124-128. 14. Taylor... Medicine , 46(3), 304-308. 8. Asknes, E. G. (1954). Effects of small doses of alcohol upon performance in a Link trainer. Journal of Aviation Medicine ...assessed by two Link trainer tasks using experienced pilots. Aerospace Medicine , 45(10), 1180-1189. 10. Henry, P. H., Flueck, J. A., Sanford, J. F

Radiation Protection Methods for the Interventionalist’s Hands: Use of an Extension Tube

DOE Office of Scientific and Technical Information (OSTI.GOV)

Dixon, Shaheen, E-mail: shaheen7noorani@gmail.com; Schick, Daniel, E-mail: Daniel.Schick@health.qld.gov.au; Harper, John, E-mail: John-Harper@health.qld.gov.au

2015-04-15

PurposeCumulative radiation exposure to the hands during certain interventional procedures may be high. It is important to decrease the amount of radiation to the operator due to the possibility of deterministic effects. We performed a pilot study to demonstrate a significant decrease in operator dose when using extension tubing (ET) in combination with shielding and collimation during a simulated percutaneous transhepatic cholangiogram (PTC) procedure.MethodsA whole body, anthropomorphic phantom was used to simulate the patient. A Unfors-Xi Survey detector (to measure scatter) supported by a retort stand and trolley was placed in various positions to simulate the position of hands andmore » eyes/thyroid of an interventionalist. Radiation dose was measured simulating left and right-sided PTC punctures with and without a lead shield, and with and without ET.ResultsRegarding the radiation dose to the hands; the use of an ET reduces dose by 54 % in right-sided PTC punctures without a shield and by 91 % if used in combination with a shield. For left-sided PTC punctures, ET reduces hand dose by 75 %. The use of collimation decreases hand dose by approximately 60 %. The use of shielding reduces dose to the eyes/thyroid by 98 %.ConclusionsThe dose to the hands can be significantly reduced with the appropriate use of a shield, ET, and tight collimation. The use of a shield is paramount to reduce dose to the eyes/thyroid. It is important for interventionalists to adhere to radiation protective practice considering the potential deterministic effects during a lifelong career.« less

Phase I Design for Completely or Partially Ordered Treatment Schedules

PubMed Central

Wages, Nolan A.; O’Quigley, John; Conaway, Mark R.

2013-01-01

The majority of methods for the design of Phase I trials in oncology are based upon a single course of therapy, yet in actual practice it may be the case that there is more than one treatment schedule for any given dose. Therefore, the probability of observing a dose-limiting toxicity (DLT) may depend upon both the total amount of the dose given, as well as the frequency with which it is administered. The objective of the study then becomes to find an acceptable combination of both dose and schedule. Past literature on designing these trials has entailed the assumption that toxicity increases monotonically with both dose and schedule. In this article, we relax this assumption for schedules and present a dose-schedule finding design that can be generalized to situations in which we know the ordering between all schedules and those in which we do not. We present simulation results that compare our method to other suggested dose-schedule finding methodology. PMID:24114957

Higher Landing Accuracy in Expert Pilots is Associated with Lower Activity in the Caudate Nucleus

PubMed Central

Adamson, Maheen M.; Taylor, Joy L.; Heraldez, Daniel; Khorasani, Allen; Noda, Art; Hernandez, Beatriz; Yesavage, Jerome A.

2014-01-01

The most common lethal accidents in General Aviation are caused by improperly executed landing approaches in which a pilot descends below the minimum safe altitude without proper visual references. To understand how expertise might reduce such erroneous decision-making, we examined relevant neural processes in pilots performing a simulated landing approach inside a functional MRI scanner. Pilots (aged 20–66) were asked to “fly” a series of simulated “cockpit view” instrument landing scenarios in an MRI scanner. The scenarios were either high risk (heavy fog–legally unsafe to land) or low risk (medium fog–legally safe to land). Pilots with one of two levels of expertise participated: Moderate Expertise (Instrument Flight Rules pilots, n = 8) or High Expertise (Certified Instrument Flight Instructors or Air-Transport Pilots, n = 12). High Expertise pilots were more accurate than Moderate Expertise pilots in making a “land” versus “do not land” decision (CFII: d′ = 3.62±2.52; IFR: d′ = 0.98±1.04; p<.01). Brain activity in bilateral caudate nucleus was examined for main effects of expertise during a “land” versus “do not land” decision with the no-decision control condition modeled as baseline. In making landing decisions, High Expertise pilots showed lower activation in the bilateral caudate nucleus (0.97±0.80) compared to Moderate Expertise pilots (1.91±1.16) (p<.05). These findings provide evidence for increased “neural efficiency” in High Expertise pilots relative to Moderate Expertise pilots. During an instrument approach the pilot is engaged in detailed examination of flight instruments while monitoring certain visual references for making landing decisions. The caudate nucleus regulates saccade eye control of gaze, the brain area where the “expertise” effect was observed. These data provide evidence that performing “real world” aviation tasks in an fMRI provide objective data regarding the relative expertise of pilots and brain regions involved in it. PMID:25426935

Assessment of potential doses to workers during postulated accident conditions at the Waste Isolation Pilot Plant

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hoover, M.D.; Farrell, R.F.; Newton, G.J.

1995-12-01

The recent 1995 WIPP Safety Analysis Report (SAR) Update provided detailed analyses of potential radiation doses to members of the public at the site boundary during postulated accident scenarios at the U.S. Department of Energy`s Waste Isolation Pilot Plant (WIPP). The SAR Update addressed the complete spectrum of potential accidents associated with handling and emplacing transuranic waste at WIPP, including damage to waste drums from fires, punctures, drops, and other disruptions. The report focused on the adequacy of the multiple layers of safety practice ({open_quotes}defense-in-depth{close_quotes}) at WIPP, which are designed to (1) reduce the likelihood of accidents and (2) limitmore » the consequences of those accidents. The safeguards which contribute to defense-in-depth at WIPP include a substantial array of inherent design features, engineered controls, and administrative procedures. The SAR Update confirmed that the defense-in-depth at WIPP is adequate to assure the protection of the public and environment. As a supplement to the 1995 SAR Update, we have conducted additional analyses to confirm that these controls will also provide adequate protection to workers at the WIPP. The approaches and results of the worker dose assessment are summarized here. In conformance with the guidance of DOE Standard 3009-94, we emphasize that use of these evaluation guidelines is not intended to imply that these numbers constitute acceptable limits for worker exposures under accident conditions. However, in conjunction with the extensive safety assessment in the 1995 SAR Update, these results indicate that the Carlsbad Area Office strategy for the assessment of hazards and accidents assures the protection of workers, members of the public, and the environment.« less

A prospective pilot study on early toxicity from a simultaneously integrated boost technique for canine sinonasal tumours using image-guided intensity-modulated radiation therapy.

PubMed

Soukup, A; Meier, V; Pot, S; Voelter, K; Rohrer Bley, C

2018-05-14

In order to overcome the common local treatment failure of canine sinonasal tumours, integrated boost techniques were tried in the cobalt/orthovoltage era, but dismissed because of unacceptable early (acute) toxicity. Intriguingly, a recent calculation study of a simultaneously integrated boost (SIB) technique for sinonasal irradiation using intensity-modulated radiation therapy (IMRT) predicted theoretical feasibility. In this prospective pilot study we applied a commonly used protocol of 10 × 4.2 Gy to the planning target volume (PTV) with a 20%-SIB dose to the gross tumour volume (GTV). Our hypothesis expected this dose escalation to be clinically tolerable if applied with image-guided IMRT. We included 9 dogs diagnosed with sinonasal tumours without local/distant metastases. For treatment planning, organs at risk were contoured according to strict anatomical guidelines. Planning volume extensions (GTV/CTV/PTV) were standardized to minimize interplanner variability. Treatments were applied with rigid patient positioning and verified daily with image guidance. After radiation therapy, we set focus on early ophthalmologic complications as well as mucosal and cutaneous toxicity. Early toxicity was evaluated at week 1, 2, 3, 8 and 12 after radiotherapy. Only mild ophthalmologic complications were found. Three patients (33%) had self-limiting moderate to severe early toxicity (grade 3 mucositis) which was managed medically. No patient developed ulcerations/haemorrhage/necrosis of skin/mucosa. The SIB protocol applied with image-guided IMRT to treat canine sinonasal tumours led to clinically acceptable side effects. The suspected increased tumour control probability and the risk of late toxicity with the used dose escalation of 20% has to be further investigated. © 2018 John Wiley & Sons Ltd.

An investigation of a hypothermic to ischemic ratio in patients following out-of-hospital cardiac arrest presenting with a shockable rhythm.

PubMed

Sawyer, Kelly N; Kurz, Michael C; Elswick, R K

2014-06-01

Targeted temperature management (TTM) improves outcome after out-of-hospital cardiac arrest (OHCA). We hypothesized that there may be a significant relationship between the dose of hypothermia, the time to return of spontaneous circulation (ROSC), and survival to discharge. Retrospective pilot investigation on 99 consecutive OHCA patients with initial shockable rhythm, surviving to admission, and undergoing TTM between 2008 and 2011. Dose of hypothermia was defined as the sum of the induction interval (time to target temperature [from ROSC to 33°C]); the controlled hypothermia interval (from reaching 33°C until rewarming); and the rewarming interval (from 33°C to 37°C). Time to ROSC was measured from pulselessness or 911 call time to ROSC. The ratio between the two was termed the hypothermic to ischemic ratio. Purposeful variable selection for logistic regression modeling was used to assess the influence of the hypothermic/ischemic ratio on survival. Odds ratios (OR) were used to examine the effects of predictor variables on survival. Of 99 patients, eight were excluded for deviation from protocol, death during protocol, or missing data. From the univariate models, survivors were more likely to be younger, have a shorter time to ROSC, and have a larger hypothermic/ischemic ratio. Survivors also had a nonsignificant trend toward a longer time to target temperature. In multivariable modeling, the hypothermic/ischemic ratio was the most significant predictor for survival (OR 2.161 [95% confidence interval 1.371, 3.404]). In this pilot study, the hypothermic to ischemic ratio was significantly associated with survival to discharge for patients with an initial shockable rhythm. Further investigation of the relationship between the dose of hypothermia and time to ROSC for postresuscitation TTM is needed.

Pilot trial of CRLX101 in patients with advanced, chemotherapy-refractory gastroesophageal cancer.

PubMed

Chao, Joseph; Lin, James; Frankel, Paul; Clark, Andrew J; Wiley, Devin T; Garmey, Edward; Fakih, Marwan; Lim, Dean; Chung, Vincent; Luevanos, Eloise; Eliasof, Scott; Davis, Mark E; Yen, Yun

2017-12-01

CRLX101 is an investigational nanoparticle-drug conjugate with a camptothecin payload. Preclinical evidence indicated preferential uptake in tumors, and tumor xenograft models demonstrate superiority of CRLX101 over irinotecan. A pilot trial was conducted at recommended phase 2 dosing (RP2D) using the bimonthly schedule to assess preferential uptake of CRLX101 in tumor vs . adjacent normal tissue in endoscopically accessible tumors in chemotherapy-refractory gastroesophageal cancer. Results from the biopsies were previously reported and herein we present the clinical outcomes. Patients initiated CRLX101 dosed at RP2D (15 mg/m 2 ) on days 1 and 15 of a 28-day cycle. Detection of preferential CRLX101 tumor uptake was the primary endpoint and objective response rate (ORR) was a secondary endpoint. With a sample size of ten patients, the study had 90% power to detect ≥1 responder if the true response rate is ≥21%. Between Dec. 2012 and Dec. 2014, ten patients with chemotherapy-refractory (median 2 prior lines of therapy, range 1-4) gastric adenocarcinoma were enrolled. The median time-to-progression was 1.7 months. Best response was seen in one patient with stable disease (SD) for 8 cycles. Only ≥ grade 3 drug-related toxicity occurred in one patient with grade 3 cardiac chest pain who was able to resume therapy after CRLX101 was reduced to 12 mg/m 2 . Bimonthly CRLX101 demonstrated minimal activity with SD as best response in this heavily pretreated population. Future efforts with CRLX101 in gastric cancer should focus on combination and more dose-intensive strategies given its favorable toxicity profile and evidence of preferential tumor uptake.

Effect of rivastigmine on mobility of patients with higher-level gait disorder: a pilot exploratory study.

PubMed

Gurevich, Tanya; Balash, Yacov; Merims, Doron; Peretz, Chava; Herman, Talia; Hausdorff, Jeffrey M; Giladi, Nir

2014-06-01

Higher-level gait disorder (HLGD) in older adults is characterized by postural instability, stepping dysrhythmicity, recurrent falls and progressive immobility. Cognitive impairments are frequently associated with HLGD. The aim of this study was to compare gait and cognitive performance before and after the use of rivastigmine in patients with HLGD, free from cognitive impairment or Parkinsonism. Fifteen non-demented patients with HLGD (age 79.2 ± 5.9 years; 11 women; Mini-Mental State Examination [MMSE] 28.3 ± 1.4) received escalating doses of rivastigmine for 12 weeks in an open-label, pilot study. They were assessed before and after treatment (week 0 and week 12), and after a 4-week washout period (week 16). Assessments included the Mindstreams computerized neuropsychological battery, Activities-specific Balance Confidence Scale, State-Trait Anxiety Inventory, Geriatric Depression Scale, Timed Up and Go (TUG) test, gait speed and stride time variability. One-way multiple analysis of variance tests for repeated measures were used, and Pillai's trace test was considered as robust to investigate significant differences. The mean dose of rivastigmine during the 8-12 week period was 5.1 ± 2.3 mg/day. A positive effect was observed on the Mindstreams memory subscale and anxiety scores [Pillai's trace: F(6,724) = 0.508, p = 0.010; and F(7,792) = 0.545, p = 0.006, respectively, over the course of the study] as well as on mobility (TUG test) [Pillai's trace: F(4,863) = 0.448; p = 0.028], whereas gait speed and stride time variability did not change. The use of relatively low-dose rivastigmine did not affect gait speed and stride time variability; however, the general mobility and anxiety were improved. These preliminary results warrant a larger, randomized, placebo-controlled study.

Riluzole for relapse prevention following intravenous ketamine in treatment-resistant depression: a pilot randomized, placebo-controlled continuation trial

PubMed Central

Mathew, Sanjay J.; Murrough, James W.; Rot, Marije aan het; Collins, Katherine A.; Reich, David L.; Charney, Dennis S.

2013-01-01

The N-methyl-d-aspartate (NMDA) glutamate receptor antagonist ketamine may have rapid, albeit transient, antidepressant properties. This study in patients with treatment-resistant major depression (TRD) aimed to (1) replicate the acute efficacy of single-dose intravenous (i.v.) ketamine; (2) test the efficacy of the glutamate-modulating agent riluzole in preventing post-ketamine relapse ; and (3) examine whether pretreatment with lamotrigine would attenuate ketamine’s psychotomimetic effects and enhance its antidepressant activity. Twenty-six medication-free patients received open-label i.v. ketamine (0.5 mg/kg over 40 min). Two hours prior to infusion, patients were randomized to lamotrigine (300 mg) or placebo. Seventeen patients (65%) met response criterion (≥50% reduction from baseline on the Montgomery–Asberg Depression Rating Scale) 24 h following ketamine. Lamotrigine failed to attenuate the mild, transient side-effects associated with ketamine and did not enhance its antidepressant effects. Fourteen patients (54%) met response criterion 72 h following ketamine and proceeded to participate in a 32-d, randomized, double-blind, placebo-controlled, flexible-dose continuation trial of riluzole (100–200 mg/d). The main outcome measure was time-to-relapse. An interim analysis found no significant differences in time-to-relapse between riluzole and placebo groups [log-rank χ2 = 0.17, d.f. = 1, p = 0.68], with 80% of patients relapsing on riluzole vs. 50% on placebo. The trial was thus stopped for futility. This pilot study showed that a sub-anaesthetic dose of i.v. ketamine is well-tolerated in TRD, and may have rapid and sustained antidepressant properties. Riluzole did not prevent relapse in the first month following ketamine. Further investigation of relapse prevention strategies post-ketamine is necessary. PMID:19288975

Kappa Agonists as a Novel Therapy for Menopausal Hot Flashes

PubMed Central

Oakley, Amy E.; Steiner, Robert A.; Chavkin, Charles; Clifton, Donald K.; Ferrara, Laura K.; Reed, Susan D.

2015-01-01

Objective Postmenopausal hot flash etiology is poorly understood, making it difficult to develop and target ideal therapies. A network of hypothalamic estrogen-sensitive neurons producing Kisspeptin, Neurokinin B, and Dynorphin (KNDy neurons), located adjacent to the thermoregulatory center, regulate pulsatile secretion of GnRH and LH. Dynorphin may inhibit this system by binding kappa opioid receptors within the vicinity of KNDy neurons. We hypothesize that hot flashes are reduced by KNDy neuron manipulation. Methods A double-blind, cross-over, placebo-controlled pilot study evaluated the effect of a kappa agonist (KA).Hot flash frequency was the primary outcome. Twelve healthy postmenopausal women with moderate-severe hot flashes, ages 48-60 years, were randomized. Eight women with sufficient baseline hot flashes for statistical analysis completed all 3 interventions: placebo, standard Pentazocine/Naloxone (50/0.5 mg) or low-dose Pentazocine/Naloxone (25/0.25 mg). In an inpatient research setting, each participant received the 3 interventions, in randomized order, on 3 separate days. On each day, an intravenous catheter was inserted for luteinizing hormone (LH) blood sampling, and skin conductance and Holter monitors were placed. Subjective hot flash frequency and severity were recorded. Results Mean hot flash frequency 2-7 hours following therapy initiation was lower than that for placebo (KA standard-dose: 4.75 ± 0.67; KA low-dose: 4.50 ± 0.57; and placebo: 5.94 ± 0.78 hot flashes/5 hours; p =0.025). Hot flash intensity did not vary between interventions. LH pulsatility mirrored objective hot flashes in some, but not all women. Conclusions This pilot suggests that kappa agonists may affect menopausal vasomotor symptoms. PMID:25988798

A pilot study of an autologous tumor-derived autophagosome vaccine with docetaxel in patients with stage IV non-small cell lung cancer.

PubMed

Sanborn, Rachel E; Ross, Helen J; Aung, Sandra; Acheson, Anupama; Moudgil, Tarsem; Puri, Sachin; Hilton, Traci; Fisher, Brenda; Coffey, Todd; Paustian, Christopher; Neuberger, Michael; Walker, Edwin; Hu, Hong-Ming; Urba, Walter J; Fox, Bernard A

2017-12-19

Tumor-derived autophagosome vaccines (DRibbles) have the potential to broaden immune response to poorly immunogenic tumors. Autologous vaccine generated from tumor cells harvested from pleural effusions was administered to patients with advanced NSCLC with the objectives of assessing safety and immune response. Four patients were vaccinated and evaluable for immune response; each received two to four doses of vaccine. Study therapy included two cycles of docetaxel 75 mg/m 2 on days 1 and 29 to treat the tumor, release hidden antigens and produce lymphopenia. DRibbles were to be administered intradermally on days 14, 43, 57, 71, and 85, together with GM-CSF (50 μg/d x 6d, administered via SQ mini pump). Peripheral blood was tested for immune parameters at baseline and at each vaccination. Three of four patients had tumor cells available for testing. Autologous tumor-specific immune response was seen in two of the three, manifested by IL-5 (1 patient after 3 doses), and IFN-γ, TNF-α, IL-5, IL-10 (after 4 doses in one patient). All 4 patients had evidence of specific antibody responses against potential tumor antigens. All patients came off study after 4 or fewer vaccine treatments due to progression of disease. No significant immune toxicities were seen during the course of the study. DRibble vaccine given with GM-CSF appeared safe and capable of inducing an immune response against tumor cells in this small, pilot study. There was no evidence of efficacy in this small poor-prognosis patient population, with treatment not feasible. Trial registration NCT00850785, initial registration date February 23, 2009.

Impact of bisphosphonate drug burden in alveolar bone during orthodontic tooth movement in a rat model: a pilot study.

PubMed

Kaipatur, Neelambar R; Wu, Yuchin; Adeeb, Samer; Stevenson, Thomas R; Major, Paul W; Doschak, Michael R

2013-10-01

The aim of this pilot study was to investigate the effect of long-term bisphosphonate drug use (bone burden) on orthodontic tooth movement in a rat model. Sprague Dawley rats were used for orthodontic protraction of the maxillary first molars with nickel-titanium coil springs and temporary anchorage devices as anchorage. Four groups of 5 rats each were included in the study; the first 2 groups were dosed with alendronate or a vehicle during concurrent orthodontic tooth movement. The third and fourth groups were pretreated for 3 months with alendronate or vehicle injections, and bisphosphonate drug treatment was discontinued before orthodontic tooth movement. Tooth movement measurements were obtained at 0, 4, and 8 weeks using high-resolution in-vivo microcomputed tomography, and the tissues were analyzed with histology and dynamic labeling of bone turnover. Appreciable tooth movement was achieved during the 8-week duration of this study with nickel-titanium coil springs and temporary anchorage devices. Both bisphosphonate treatment groups exhibited reduced tooth movement compared with the vehicle-dosed controls with a tendency toward more severe reduction in the bisphosphonate predosed group. Concurrent dosing of the bisphosphonate drug resulted in 56% and 65% reductions in tooth protraction at the 4-week and 8-week times, respectively. The impact of bisphosphonate bone burden in retarding tooth movement was even greater, with 77% and 86% reductions in tooth movement at 4 and 8 weeks, respectively. In this study, we used a robust rat model of orthodontic tooth movement with temporary anchorage devices. It has provided evidence that the bone burden of previous bisphosphonate use will significantly inhibit orthodontic tooth movement. Copyright © 2013 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.

Perceptions About Hospice From a Community-Based Pilot Study: Lessons and Findings

PubMed Central

Van Dussen, Daniel; Culler, Krystal L.; Cagle, John G.

2016-01-01

Research investigating the knowledge and attitudes of diverse older adults about hospice care and end-of-life issues is needed to expand service utilization. This pilot study explored an urban area’s perceptions and awareness of hospice through local churches. The sample consisted of 148 adults age 43 and older. Although recruitment efforts resulted in a relatively homogenous sample, findings suggest a lack of knowledge about whether hospice is covered by Medicare, Medicaid, or private insurance. Perceptions of the expense of hospice, however, were not associated with knowledge of coverage. Respondents generally agreed that hospice is important and would recommend its services for their family members. PMID:21208898

Introducing the health coach at a primary care practice: a pilot study (part 2).

PubMed

Lanese, Bethany Sneed; Dey, Asoke; Srivastava, Prashant; Figler, Robert

2011-01-01

It is well known that the cost of healthcare in the United States is a poor value proposition. One of the primary goals of the healthcare reform act is to reduce cost while improving healthcare quality. The authors believe that adding a health coach helps to achieve this goal. In part I, the authors discuss the role of a health coach in the healthcare field. They present the findings from a pilot study at a primary care practice managing diabetes of patients using a health coach. The findings from the study suggest that adding a health coach helps in cost savings as well as improved health for the patients.

Training monitoring skills in helicopter pilots.

PubMed

Potter, Brian A; Blickensderfer, Elizabeth L; Boquet, Albert J

2014-05-01

Prior research has indicated that ineffective pilot monitoring has been associated with aircraft accidents. Despite this finding, empirical research concerning pilot monitoring skill training programs is nearly nonexistent. E-learning may prove to be an effective method to foster nontechnical flight skills, including monitoring. This study examined the effect of using e-learning to enhance helicopter aircrew monitoring skill performance. The design was a posttest only field study. Forty-four helicopter pilots completed either an e-learning training module or a control activity and then flew two scenarios in a high-fidelity flight simulator. Learner reactions and knowledge gained were assessed immediately following the e-learning module. Two observer raters assessed behaviors and performance outcomes using recordings of the simulation flights. Subjects who completed the e-learning training module scored almost twice as high as did the control group on the administered knowledge test (experimental group, mean = 92.8%; control group, mean = 47.7%) and demonstrated up to 150% more monitoring behaviors during the simulated flights than the control subjects. In addition, the participating pilots rated the course highly. The results supported the hypothesis that a relatively inexpensive and brief training course implemented through e-learning can foster monitoring skill development among helicopter pilots.

Substance Use Recovery Outcomes among a Cohort of Youth Participating in a Mobile-Based Texting Aftercare Pilot Program

PubMed Central

Gonzales, Rachel; Ang, Alfonso; Murphy, Debra A.; Glik, Deborah C.; Anglin, M. Douglas

2014-01-01

Project ESQYIR (Educating & Supporting inquisitive Youth in Recovery) is a pilot study examining the feasibility of a 12-week mobile-based aftercare intervention for youth (ages 12 to 24) transitioning out of community-based substance abuse treatment programs. From January 2012 through July 2013, a total of 80 youth were recruited from outpatient and residential treatment programs, geographically dispersed throughout Los Angeles County, California. Results revealed that youth who participated in the texting mobile pilot intervention were significantly less likely to relapse to their primary compared to the aftercare as usual control condition (OR = 0.52, p = 0.002) over time (from baseline throughout the 12-week aftercare pilot program to a 90-day follow-up). Participants in the texting aftercare pilot program also reported significantly less substance use problem severity (β = −0.46, p = .03) and were more likely to participate in extracurricular recovery behaviors (β = 1.63, p = .03) compared to participants in the standard aftercare group. Collectively, findings from this pilot aftercare study suggest that mobile texting could provide a feasible way to engage youth in recovery after substance abuse treatment to aid with reducing relapse and promoting lifestyle behavior change. PMID:24629885

Photogrammetry on the identification of postural asymmetries in cadets and pilots of the Brazilian air force academy.

PubMed

Figueiredo, Rodrigo V; Amaral, Artur C; Shimano, Antônio C

2012-01-01

To identify whether flight training activities cause postural changes in cadets and pilots of the Brazilian Air Force Academy (AFA). Eighty subjects were assessed through photographic images in anterior and right side views. Four groups of cadets (n=20 per group) divided according to the year since enlistment and a fifth group of fifteen pilots from the Air Demonstration Squadron (ADS) were included. Pictures were analyzed using the Postural Analysis Program (SAPO) and angles related to head vertical alignment (HVA), head horizontal alignment (HHA), acromion horizontal alignment (AHA) and anterior-superior iliac spine horizontal alignment (HAS) were plotted. We did not find statistical significant differences in the angles: HVA, HHA and AHA. However, a significant difference was found for the HAS angle with pilots having lower values than cadets, suggesting greater postural stability for this variable in pilots. The horizontal alignment of the anterior-superior iliac spine was the only measure that showed significant difference in the comparison between pilots and cadets. The remaining alignments were not different, possibility because of the strict criteria used for admission of cadets at the AFA and the efficiency of the physical training that is performed periodically.

Airborne Use of Traffic Intent Information in a Distributed Air-Ground Traffic Management Concept: Experiment Design and Preliminary Results

NASA Technical Reports Server (NTRS)

Wing, David J.; Adams, Richard J.; Duley, Jacqueline A.; Legan, Brian M.; Barmore, Bryan E.; Moses, Donald

2001-01-01

A predominant research focus in the free flight community has been on the type of information required on the flight deck to enable pilots to "autonomously" maintain separation from other aircraft. At issue are the relative utility and requirement for information exchange between aircraft regarding the current "state" and/or the "intent" of each aircraft. This paper presents the experimental design and some initial findings of an experimental research study designed to provide insight into the issue of intent information exchange in constrained en-route operations and its effect on pilot decision making and flight performance. Two operational modes for autonomous operations were compared in a piloted simulation. The tactical mode was characterized primarily by the use of state information for conflict detection and resolution and an open-loop means for the pilot to meet operational constraints. The strategic mode involved the combined use of state and intent information, provided the pilot an additional level of alerting, and allowed a closed-loop approach to meeting operational constraints. Potential operational benefits of both modes are illustrated through several scenario case studies. Subjective data results are presented that generally indicate pilot consensus in favor of the strategic mode.

Ultra-Low-Dose Fetal CT With Model-Based Iterative Reconstruction: A Prospective Pilot Study.

PubMed

Imai, Rumi; Miyazaki, Osamu; Horiuchi, Tetsuya; Asano, Keisuke; Nishimura, Gen; Sago, Haruhiko; Nosaka, Shunsuke

2017-06-01

Prenatal diagnosis of skeletal dysplasia by means of 3D skeletal CT examination is highly accurate. However, it carries a risk of fetal exposure to radiation. Model-based iterative reconstruction (MBIR) technology can reduce radiation exposure; however, to our knowledge, the lower limit of an optimal dose is currently unknown. The objectives of this study are to establish ultra-low-dose fetal CT as a method for prenatal diagnosis of skeletal dysplasia and to evaluate the appropriate radiation dose for ultra-low-dose fetal CT. Relationships between tube current and image noise in adaptive statistical iterative reconstruction and MBIR were examined using a 32-cm CT dose index (CTDI) phantom. On the basis of the results of this examination and the recommended methods for the MBIR option and the known relationship between noise and tube current for filtered back projection, as represented by the expression SD = (milliamperes) -0.5 , the lower limit of the optimal dose in ultra-low-dose fetal CT with MBIR was set. The diagnostic power of the CT images obtained using the aforementioned scanning conditions was evaluated, and the radiation exposure associated with ultra-low-dose fetal CT was compared with that noted in previous reports. Noise increased in nearly inverse proportion to the square root of the dose in adaptive statistical iterative reconstruction and in inverse proportion to the fourth root of the dose in MBIR. Ultra-low-dose fetal CT was found to have a volume CTDI of 0.5 mGy. Prenatal diagnosis was accurately performed on the basis of ultra-low-dose fetal CT images that were obtained using this protocol. The level of fetal exposure to radiation was 0.7 mSv. The use of ultra-low-dose fetal CT with MBIR led to a substantial reduction in radiation exposure, compared with the CT imaging method currently used at our institution, but it still enabled diagnosis of skeletal dysplasia without reducing diagnostic power.

SU-D-BRC-05: Effects of Motion and Variable RBE in a Lung Patient Treated with Passively Scattered Protons

DOE Office of Scientific and Technical Information (OSTI.GOV)

Mirkovic, D; Titt, U; Mohan, R

2016-06-15

Purpose: To evaluate effects of motion and variable relative biological effectiveness (RBE) in a lung cancer patient treated with passively scattered proton therapy using dose volume histograms associated with patient dose computed using three different methods. Methods: A proton treatment plan of a lung cancer patient optimized using clinical treatment planning system (TPS) was used to construct a detailed Monte Carlo (MC) model of the beam delivery system and the patient specific aperture and compensator. A phase space file containing all particles transported through the beam line was collected at the distal surface of the range compensator and subsequently transportedmore » through two different patient models. The first model was based on the average CT used by the TPS and the second model included all 10 phases of the corresponding 4DCT. The physical dose and proton linear energy transfer (LET) were computed in each voxel of two models and used to compute constant and variable RBE MC dose on average CT and 4D CT. The MC computed doses were compared to the TPS dose using dose volume histograms for relevant structures. Results: The results show significant differences in doses to the target and critical structures suggesting the need for more accurate proton dose computation methods. In particular, the 4D dose shows reduced coverage of the target and higher dose to the spinal cord, while variable RBE dose shows higher lung dose. Conclusion: The methodology developed in this pilot study is currently used for the analysis of a cohort of ∼90 lung patients from a clinical trial comparing proton and photon therapy for lung cancer. The results from this study will help us in determining the clinical significance of more accurate dose computation models in proton therapy.« less

Single oral doses of netazepide (YF476), a gastrin receptor antagonist, cause dose-dependent, sustained increases in gastric pH compared with placebo and ranitidine in healthy subjects.

PubMed

Boyce, M; David, O; Darwin, K; Mitchell, T; Johnston, A; Warrington, S

2012-07-01

Nonclinical studies have shown netazepide (YF476) to be a potent, selective, competitive and orally active gastrin receptor antagonist. To administer to humans for the first time single oral doses of netazepide, to assess their tolerability, safety, pharmacokinetics and effect on 24-h gastric pH. We did two randomised double-blind single-dose studies in healthy subjects. The first (n = 12) was a six-way incomplete crossover pilot study of rising doses of netazepide (range 0.5-100 mg) and placebo. The second (n = 20) was a five-way complete crossover study of netazepide 5, 25 and 100 mg, ranitidine 150 mg and placebo. In both trials we collected frequent blood samples, measured plasma netazepide and calculated pharmacokinetic parameters. In the comparative trial we measured gastric pH continuously for 24 h and compared treatments by percentage time gastric pH ≥4. Netazepide was well tolerated. Median t (max) and t (½) for the 100 mg dose were about 1 and 7 h, respectively, and the pharmacokinetics were dose-proportional. Netazepide and ranitidine each increased gastric pH. Onset of activity was similarly rapid for both. All netazepide doses were more effective than placebo (P ≤ 0.023). Compared with ranitidine, netazepide 5 mg was as effective, and netazepide 25 and 100 mg were much more effective (P ≤ 0.010), over the 24 h after dosing. Activity of ranitidine lasted about 12 h, whereas that of netazepide exceeded 24 h. In human: netazepide is an orally active gastrin antagonist, and gastrin has a major role in controlling gastric acidity. Repeated-dose studies are justified. NCT01538784 and NCT01538797. © 2012 Blackwell Publishing Ltd.

Cross-sectional study of neck pain and cervical sagittal alignment in air force pilots.

PubMed

Moon, Bong Ju; Choi, Kyong Ho; Yun, Chul; Ha, Yoon

2015-05-01

There is a high prevalence of neck pain in air force pilots; however, the causes are not clear and are considered work-related. Kyphotic changes in the cervical spine have been known to cause neck pain. In this study, we investigated the association between neck pain and cervical kyphosis in air force pilots. This is a cross-sectional study of 63 Republic of South Korea Air Force pilots. We examined the C2-7 absolute rotation angle (ARA) using the posterior tangent method and other radiologic parameters on whole spine lateral radiographs. We divided the participants into a neck pain group (N = 32) and no neck pain group (N = 31), and subsequently analyzed the difference in radiographic parameters and clinical data between the two groups. There were no significant differences found in age, body mass index, total flight time, or aerobic or anaerobic exercise between the neck pain and control groups. The fighter pilots had higher 1-yr prevalence of neck pain than nonfighter pilots (84.4% vs. 15.6%). The lower C2-7 ARA (OR = 0.91, 95% CI 0.846, 0.979) and fighter type aircrafts (OR = 3.93, 95% CI 1.104, 13.989) were associated with neck pain. Fighter pilots experienced neck pain more frequently than the nonfighter pilots. Those fighter pilots suffering from neck pain were shown to have more kyphotic changes in the cervical spine than control pilots through evaluation of whole spine lateral radiographs using the posterior tangent method. These key findings suggest that the forces involved in flying a fighter type aircraft may affect cervical alignment and neck pain.

Variations in Party Line Information Requirements for Flight Crew Situation Awareness in the Datalink Environment

NASA Technical Reports Server (NTRS)

Pritchett, Amy R.; Hansman, R. John

1994-01-01

Current Air Traffic Control communications use shared very high frequency (VHF) voice frequencies from which pilots can obtain 'Party Line' Information (PLI) by overhearing communications addressed to other aircraft. A prior study has shown pilots perceive this PLI to be important. There is concern that some critical PLI may be lost in the proposed datalink environment where communications will be discretely addressed. Different types of flight operations will be, equipped with datalink equipment at different times, generating a 'mixed environment' where some pilots may rely on PLI while others will receive their information by datalink. To research the importance, availability and accuracy of PLI and to query pilots on the information they feel is necessary, a survey was distributed to pilots. The pilots were selected from four flight operation groups to study the variations in PLI requirements in the mixed datalink environment. Pilots perceived PLI to be important overall. Specific information elements pertaining to traffic and weather information were identified as Critical. Most PLI elements followed a pattern of higher perceived importance during terminal area operations, final approach and landing. Pilots from the different flight operation groups identified some elements as particularly important. Pilots perceived PLI to be only moderately available and accurate overall. Several PLI elements received very low availability and accuracy ratings but are perceived as important. In a free response question designed to find the information requirements for global situation awareness, pilots frequently indicated a need for traffic and weather information. These elements were also frequently cited by them as information that could be presented by a datalink system. The results of this survey identify specific concerns to be addressed when implementing datalink communications.

Finding safety: a pilot study of managed alcohol program participants' perceptions of housing and quality of life.

PubMed

Pauly, Bernadette Bernie; Gray, Erin; Perkin, Kathleen; Chow, Clifton; Vallance, Kate; Krysowaty, Bonnie; Stockwell, Timothy

2016-05-09

There is a higher prevalence of alcohol use and severe alcohol dependence among homeless populations. The combination of alcohol use and lack of housing contributes to increased vulnerability to the harms of substance use including stigma, injury, illness, and death. Managed alcohol programs (MAPs) administer prescribed doses of alcohol at regular intervals to people with severe and chronic alcohol dependence and homelessness. As a pilot for a larger national study of MAPs, we conducted an in-depth evaluation of one program in Ontario, Canada. In this paper, we report on housing and quality of life outcomes and experiences of the MAP participants and staff. We conducted a pilot study using mixed methods. The sample consisted of 38 people enrolled in or eligible for entry into a MAP who completed a structured quantitative survey that included measures related to their housing and quality of life. All of the participants self-identified as Indigenous. In addition, we conducted 11 in-depth qualitative interviews with seven MAP residents and four program staff and analyzed the interviews using constant comparative analysis. The qualitative analysis was informed by Rhodes' risk environment framework. When compared to controls, MAP participants were more likely to retain their housing and experienced increased safety and improved quality of life compared to life on the streets, in jails, shelters, or hospitals. They described the MAP as a safe place characterized by caring, respect, trust and a nonjudgmental approach with a sense of family and home as well as opportunities to reconnect with family members. The MAP was, as described by participants, a safer environment and a home with feelings of family and a sense of community that countered stigma, loss, and dislocation with potential for healing and recovery. The MAP environment characterized by caring, respect, trust, a sense of home, "feeling like family", and the opportunities for family and cultural reconnections is consistent with First Nations principles for healing and recovery and principles of harm reduction.

Civilian Health Insurance Options of Military Retirees: Findings from a Pilot Survey

DTIC Science & Technology

2007-01-01

while providing important information, was a pilot study with a small sample size. Understanding the potential impact of an increase in TRICARE...that relies on TRICARE—even if they do not currently use TRICARE—is relevant from an actuarial standpoint. Nonusers who view TRICARE as their...primary source of health insurance coverage will pose an actuarial risk if they become unhealthy in the future. Purpose of This Report This report

Pharmacodynamic comparison of two formulations of Acarbose 100-mg tablets.

PubMed

Lee, S; Chung, J Y; Hong, K S; Yang, S-H; Byun, S-Y; Lim, H-S; Shin, S-G; Jang, I-J; Yu, K-S

2012-10-01

Acarbose, an α-glycosidase inhibitor, is used to treat diabetic patients. Pharmacokinetic evaluation of acarbose is difficult because <2% is absorbed systemically. The current investigation evaluated the bioequivalence of two formulations of acarbose through pharmacodynamic comparison. This investigation consisted of a pilot study and a main study. The pilot study had an open, single-dose, single-sequence design. Subjects received placebo and then two tablets of reference formulation (Glucobay(®) 100 mg tablet; Bayer Healthcare) on two consecutive days with sucrose. The main study was an open, randomized, two-period, two-sequence crossover study. Subjects randomly received placebo and two tablets of either test formulation (generic acarbose 100-mg tablet) or reference formulation with sucrose on two consecutive days in the first period. In the second period, placebo and alternative formulation were administered. Serial blood samples for pharmacodynamic assessment were taken after each administration. The maximum serum glucose concentration (G(max)) and the area under the serum glucose concentration-time profile (AUC(gluc)) were determined and compared. Five subjects completed the pilot study. The AUC(gluc) from dosing until 1 h post-dose (AUC(gluc,1 h)) was significantly different between the placebo and acarbose. A total of 33 subjects completed the main study. The mean differences in G(max) (ΔG(max)) and AUC(gluc,1 h) (ΔAUC(gluc,1 h)) for the reference formulation compared with placebo were 22·0 ± 18·3 mg/dL and 928·2 ± 756·0 mg min/dL, respectively. The corresponding values for the test formulation were 23·3 ± 21·2 mg/dL and 923·0 ± 991·4 0 mg min/dL, respectively. The geometric mean ratios (GMRs) of the test formulation to the reference formulation for ΔG(max) and ΔAUC(gluc, 1 h) were 1·06 and 1·00, respectively, and the 90% confidence intervals (CIs) corresponding values were 0·79-1·39 and 0·64-1·36, respectively. The 90% CIs of GMRs for the pharmacodynamic parameters chosen for bioequivalence evaluation of two formulations of acarbose did not meet the commonly accepted regulatory criteria for bioequivalence (0·80-1·25). © 2012 Blackwell Publishing Ltd.

Increasing upper limb training intensity in chronic stroke using embodied virtual reality: a pilot study.

PubMed

Perez-Marcos, Daniel; Chevalley, Odile; Schmidlin, Thomas; Garipelli, Gangadhar; Serino, Andrea; Vuadens, Philippe; Tadi, Tej; Blanke, Olaf; Millán, José D R

2017-11-17

Technology-mediated neurorehabilitation is suggested to enhance training intensity and therefore functional gains. Here, we used a novel virtual reality (VR) system for task-specific upper extremity training after stroke. The system offers interactive exercises integrating motor priming techniques and embodied visuomotor feedback. In this pilot study, we examined (i) rehabilitation dose and training intensity, (ii) functional improvements, and (iii) safety and tolerance when exposed to intensive VR rehabilitation. Ten outpatient stroke survivors with chronic (>6 months) upper extremity paresis participated in a ten-session VR-based upper limb rehabilitation program (2 sessions/week). All participants completed all sessions of the treatment. In total, they received a median of 403 min of upper limb therapy, with 290 min of effective training. Within that time, participants performed a median of 4713 goal-directed movements. Importantly, training intensity increased progressively across sessions from 13.2 to 17.3 movements per minute. Clinical measures show that despite being in the chronic phase, where recovery potential is thought to be limited, participants showed a median improvement rate of 5.3% in motor function (Fugl-Meyer Assessment for Upper Extremity; FMA-UE) post intervention compared to baseline, and of 15.4% at one-month follow-up. For three of them, this improvement was clinically significant. A significant improvement in shoulder active range of motion (AROM) was also observed at follow-up. Participants reported very low levels of pain, stress and fatigue following each session of training, indicating that the intensive VR intervention was well tolerated. No severe adverse events were reported. All participants expressed their interest in continuing the intervention at the hospital or even at home, suggesting high levels of adherence and motivation for the provided intervention. This pilot study showed how a dedicated VR system could deliver high rehabilitation doses and, importantly, intensive training in chronic stroke survivors. FMA-UE and AROM results suggest that task-specific VR training may be beneficial for further functional recovery both in the chronic stage of stroke. Longitudinal studies with higher doses and sample sizes are required to confirm the therapy effectiveness. This trial was retrospectively registered at ClinicalTrials.gov database (registration number NCT03094650 ) on 14 March 2017.

Personalized technologist dose audit feedback for reducing patient radiation exposure from CT.

PubMed

Miglioretti, Diana L; Zhang, Yue; Johnson, Eric; Lee, Choonsik; Morin, Richard L; Vanneman, Nicholas; Smith-Bindman, Rebecca

2014-03-01

The aim of this study was to determine whether providing radiologic technologists with audit feedback on doses from CT examinations they conduct and education on dose-reduction strategies reduces patients' radiation exposure. This prospective, controlled pilot study was conducted within an integrated health care system from November 2010 to October 2011. Ten technologists at 2 facilities received personalized dose audit reports and education on dose-reduction strategies; 9 technologists at a control facility received no intervention. Radiation exposure was measured by the dose-length product (DLP) from CT scans performed before (n = 1,630) and after (n = 1,499) the intervention and compared using quantile regression. Technologists were surveyed before and after the intervention. For abdominal CT, DLPs decreased by 3% to 12% at intervention facilities but not at the control facility. For brain CT, DLPs significantly decreased by 7% to 12% at one intervention facility; did not change at the second intervention facility, which had the lowest preintervention DLPs; and increased at the control facility. Technologists were more likely to report always thinking about radiation exposure and associated cancer risk and optimizing settings to reduce exposure after the intervention. Personalized audit feedback and education can change technologists' attitudes about, and awareness of, radiation and can lower patient radiation exposure from CT imaging. Copyright © 2014 American College of Radiology. All rights reserved.

Feasibility and usability of a text message-based program for diabetes self-management in an urban African-American population.

PubMed

Dick, Jonathan J; Nundy, Shantanu; Solomon, Marla C; Bishop, Keisha N; Chin, Marshall H; Peek, Monica E

2011-09-01

We pilot-tested a text message-based diabetes care program in an urban African-American population in which automated text messages were sent to participants with personalized medication, foot care, and appointment reminders and text messages were received from participants on adherence. Eighteen patients participated in a 4-week pilot study. Baseline surveys collected data about demographics, historical cell phone usage, and adherence to core diabetes care measures. Exit interview surveys (using close-coded and open-ended questions) were administered to patients at the end of the program. A 1-month follow-up interview was conducted surveying patients on perceived self-efficacy. Wilcoxon signed-rank tests were used to compare baseline survey responses about self-management activities to those at the pilot's end and at 1-month follow-up. Eighteen urban African-American participants completed the pilot study. The average age was 55 and the average number of years with diabetes was 8. Half the participants were initially uncomfortable with text messaging. Example messages include "Did you take your diabetes medications today" and "How many times did you check your feet for wounds this week?" Participants averaged 220 text messages with the system, responded to messages 80% of the time, and on average responded within 6 minutes. Participants strongly agreed that text messaging was easy to perform and helped with diabetes self-care. Missed medication doses decreased from 1.6 per week to 0.6 (p = .003). Patient confidence in diabetes self-management was significantly increased during and 1 month after the pilot (p = .002, p = .008). Text messaging may be a feasible and useful approach to improve diabetes self-management in urban African Americans. © 2011 Diabetes Technology Society.

Evaluation of radiation exposure with Tru-Align intraoral rectangular collimation system using OSL dosimeters.

PubMed

Goren, Arthur D; Bonvento, Michael J; Fernandez, Thomas J; Abramovitch, Kenneth; Zhang, Wenjian; Roe, Nadine; Seltzer, Jared; Steinberg, Mitchell; Colosi, Dan C

2011-03-01

A pilot study to compare radiation exposure with the Tru-Align rectangular collimation system to round collimation exposures was undertaken. Radiation exposure at various points within the cross sections of the collimators and entrance, intraoral and exit dose measurements were measured using InLight OSL dosimeters. Overall dose reduction with the use of the rectangular collimation system was estimated by taking into account the ratios of collimator openings and the average radiation exposure at the measurement points. Use of the Tru-Align system resulted in an average radiation exposure within the perimeter of the projected outline of the rectangular collimator of 36.1 mR, compared to 148.5 mR with the round collimator. Our calculations indicate a dose reduction by a factor of approximately 3.2 in the case of the Tru-Align system compared to round collimation. The Tru-Align system was easy to use, but in some situations failed to allow Xray coverage of the entire surface of the image receptor, leading to cone cuts.

NASA's Single-Pilot Operations Technical Interchange Meeting: Proceedings and Findings

NASA Technical Reports Server (NTRS)

Comerford, Doreen; Brandt, Summer L.; Lachter, Joel B.; Wu, Shu-Chieh; Mogford, Richard H.; Battiste, Vernol; Johnson, Walter W.

2013-01-01

Researchers at the National Aeronautics and Space Administration (NASA) Ames Research Center and Langley Research Center are jointly investigating issues associated with potential concepts, or configurations, in which a single pilot might operate under conditions that are currently reserved for a minimum of two pilots. As part of early efforts, NASA Ames Research Center hosted a technical interchange meeting in order to gain insight from members of the aviation community regarding single-pilot operations (SPO). The meeting was held on April 10-12, 2012 at NASA Ames Research Center. Professionals in the aviation domain were invited because their areas of expertise were deemed to be directly related to an exploration of SPO. NASA, in selecting prospective participants, attempted to represent various relevant sectors within the aviation domain. Approximately 70 people representing government, academia, and industry attended. A primary focus of this gathering was to consider how tasks and responsibilities might be re-allocated to allow for SPO.

PRACA Enhancement Pilot Study Report: Engineering for Complex Systems Program (formerly Design for Safety), DFS-IC-0006

NASA Technical Reports Server (NTRS)

Korsmeyer, David; Schreiner, John

2002-01-01

This technology evaluation report documents the findings and recommendations of the Engineering for Complex Systems Program (formerly Design for Safety) PRACA Enhancement Pilot Study of the Space Shuttle Program's (SSP's) Problem Reporting and Corrective Action (PRACA) System. A team at NASA Ames Research Center (ARC) performed this Study. This Study was initiated as a follow-on to the NASA chartered Shuttle Independent Assessment Team (SIAT) review (performed in the Fall of 1999) which identified deficiencies in the current PRACA implementation. The Pilot Study was launched with an initial qualitative assessment and technical review performed during January 2000 with the quantitative formal Study (the subject of this report) started in March 2000. The goal of the PRACA Enhancement Pilot Study is to evaluate and quantify the technical aspects of the SSP PRACA systems and recommend enhancements to address deficiencies and in preparation for future system upgrades.

Quantifying Pilot Visual Attention in Low Visibility Terminal Operations

NASA Technical Reports Server (NTRS)

Ellis, Kyle K.; Arthur, J. J.; Latorella, Kara A.; Kramer, Lynda J.; Shelton, Kevin J.; Norman, Robert M.; Prinzel, Lawrence J.

2012-01-01

Quantifying pilot visual behavior allows researchers to determine not only where a pilot is looking and when, but holds implications for specific behavioral tracking when these data are coupled with flight technical performance. Remote eye tracking systems have been integrated into simulators at NASA Langley with effectively no impact on the pilot environment. This paper discusses the installation and use of a remote eye tracking system. The data collection techniques from a complex human-in-the-loop (HITL) research experiment are discussed; especially, the data reduction algorithms and logic to transform raw eye tracking data into quantified visual behavior metrics, and analysis methods to interpret visual behavior. The findings suggest superior performance for Head-Up Display (HUD) and improved attentional behavior for Head-Down Display (HDD) implementations of Synthetic Vision System (SVS) technologies for low visibility terminal area operations. Keywords: eye tracking, flight deck, NextGen, human machine interface, aviation

An Investigation of Large Tilt-Rotor Short-Term Attitude Response Handling Qualities Requirements in Hover

NASA Technical Reports Server (NTRS)

Malcipa, Carlos; Decker, William A.; Theodore, Colin R.; Blanken, Christopher L.; Berger, Tom

2010-01-01

A piloted simulation investigation was conducted using the NASA Ames Vertical Motion Simulator to study the impact of pitch, roll and yaw attitude bandwidth and phase delay on handling qualities of large tilt-rotor aircraft. Multiple bandwidth and phase delay pairs were investigated for each axis. The simulation also investigated the effect that the pilot offset from the center of gravity has on handling qualities. While pilot offset does not change the dynamics of the vehicle, it does affect the proprioceptive and visual cues and it can have an impact on handling qualities. The experiment concentrated on two primary evaluation tasks: a precision hover task and a simple hover pedal turn. Six pilots flew over 1400 data runs with evaluation comments and objective performance data recorded. The paper will describe the experiment design and methodology, discuss the results of the experiment and summarize the findings.

Occupational exposure to noise and hypertension in pilots.

PubMed

Tomei, Francesco; De Sio, Simone; Tomao, Enrico; Anzelmo, Vincenza; Baccolo, Tiziana Paola; Ciarrocca, Manuela; Cherubini, Emilia; Valentini, Valentina; Capozzella, Assunta; Rosati, Maria Valeria

2005-04-01

The role of occupational exposure to noise as a hypertension risk factor has not been established sufficiently. The aim of the study is to evaluate whether chronic exposure to different levels of noise in two groups of pilots, operating with two types of aircraft, could be a risk for hypertension, what relevance the parameters (intensity, duration and type) of exposure can have and, lastly, whether there are any links between hearing impairment and hypertension. After excluding pilots with confounding factors, a study was made of 77 male pilots of turboprop planes (group A) and 224 male pilots of jet aircraft (group B), matched by age and working life. Blood pressure (supine and standing positions) and heart rate were measured. Electrocardiogram, stress tests on a cycle ergometer, sound-level measurement and audiometric tests were also done. Pilots of group A were exposed to Leq of 93 dBA while pilots of group B were exposed to the Leq of 79 dBA. Significant results in group A compared to group B were found between heart rate, blood pressure, drop in blood pressure, parameters (intensity, duration and type) of exposure to noise and between hearing damage and hypertension. The findings suggest that chronic exposure to noise is a risk factor for blood hypertension in pilots exposed to high noise levels, and that the drop in blood pressure may be a sign of more sensitive effect of noise on blood pressure, according to other studies in literature.

Dealing With Unexpected Events on the Flight Deck: A Conceptual Model of Startle and Surprise.

PubMed

Landman, Annemarie; Groen, Eric L; van Paassen, M M René; Bronkhorst, Adelbert W; Mulder, Max

2017-12-01

A conceptual model is proposed in order to explain pilot performance in surprising and startling situations. Today's debate around loss of control following in-flight events and the implementation of upset prevention and recovery training has highlighted the importance of pilots' ability to deal with unexpected events. Unexpected events, such as technical malfunctions or automation surprises, potentially induce a "startle factor" that may significantly impair performance. Literature on surprise, startle, resilience, and decision making is reviewed, and findings are combined into a conceptual model. A number of recent flight incident and accident cases are then used to illustrate elements of the model. Pilot perception and actions are conceptualized as being guided by "frames," or mental knowledge structures that were previously learned. Performance issues in unexpected situations can often be traced back to insufficient adaptation of one's frame to the situation. It is argued that such sensemaking or reframing processes are especially vulnerable to issues caused by startle or acute stress. Interventions should focus on (a) increasing the supply and quality of pilot frames (e.g., though practicing a variety of situations), (b) increasing pilot reframing skills (e.g., through the use of unpredictability in training scenarios), and (c) improving pilot metacognitive skills, so that inappropriate automatic responses to startle and surprise can be avoided. The model can be used to explain pilot behavior in accident cases, to design experiments and training simulations, to teach pilots metacognitive skills, and to identify intervention methods.

Pharmacokinetics and pharmacodynamics of MD1003 (high-dose biotin) in the treatment of progressive multiple sclerosis.

PubMed

Peyro Saint Paul, Laure; Debruyne, Danièle; Bernard, Delphine; Mock, Donald M; Defer, Gilles L

2016-01-01

Multiple sclerosis (MS) is a chronic, potentially highly disabling neurological disorder. No disease-modifying treatments are approved in the progressive and not active forms of the disease. High doses of biotin were tested in an open-label pilot study involving 23 patients with progressive MS and reported positive results. A randomized, double-blind, placebo-controlled trial in 154 progressive MS patients confirmed the beneficial effect of MD1003 (high-dose biotin) on reversing or stabilizing disability progression, with a good safety profile. It is proposed that MD1003 in progressive MS 1) increases energy production in demyelinated axons and/or 2) enhances myelin synthesis in oligodendrocytes. Biotin is highly bioavailable; absorption and excretion are rapid. The major route of elimination is urinary excretion. A high oral dose of biotin seems generally well tolerated but a few important safety concerns were identified: 1) teratogenicity in one species and 2) interference with some biotin-based laboratory immunoassays. The animal toxicity data are limited at such high doses. Further preclinical studies would be useful to address the mechanism of action of MD1003. Assessment of clinical benefit duration in responders will be also very important to set. Results of randomized, placebo-controlled trial are reassuring and provide hope for the treatment of progressive MS.

Uptake of all-trans retinoic acid–containing aerosol by inhalation to lungs in a guinea pig model system—A pilot study

PubMed Central

Schäffer, Michael W.; Roy, Somdutta Sinha; Mukherjee, Shyamali; Ong, David E.; Das, Salil K.

2010-01-01

Systemic therapies with retinoic acid (RA) can result in toxic side effects without yielding biologically effective levels in target tissues such as lung. The authors adapted a PARI LC Star nebulizer to create a tubular system for short-term inhalation treatment of guinea pigs using a water-miscible formulation of all-trans RA (ATRA) or vehicle. Based on the initial average weight, animals received an estimated average ATRA doses of either 0.32 mg·kg−1 (low dose, 1.4 mM), or 0.62 mg·kg−1 (medium dose, 2.8 mM), or 1.26 mg·kg−1 (high dose, 5.6 mM) 20 minutes per day for 6 consecutive days. This system led to a rise of ATRA levels in lung, but not liver or plasma. Cellular lung levels of retinol, retinyl palmitate, and retinyl stearate also appeared to be unaffected (245.6 ± 10.7, 47.4 ± 3.4, and 132.8 ± 7.7 ng·g−1 wet weight, respectively). The application of this aerosolized ATRA also induced a dose-dependent protein expression of the cellular retinol-binding protein 1 (CRBP-1) in lung, without apparent harmful side effects. PMID:21043991

The diuretic effect in human subjects of an extract of Taraxacum officinale folium over a single day.

PubMed

Clare, Bevin A; Conroy, Richard S; Spelman, Kevin

2009-08-01

Taraxacum officinale (L.) Weber (Asteraceae) has been extensively employed as a diuretic in traditional folk medicine and in modern phytotherapy in Europe, Asia, and the Americas without prior clinical trial substantiation. In this pilot study, a high-quality fresh leaf hydroethanolic extract of the medicinal plant T. officinale (dandelion) was ingested by volunteers to investigate whether an increased urinary frequency and volume would result. Volume of urinary output and fluid intake were recorded by subjects. Baseline values for urinary frequency and excretion ratio (urination volume:fluid intake) were established 2 days prior to dandelion dosing (8 mL TID) and monitored throughout a 1-day dosing period and 24 hours postdosing. For the entire population (n = 17) there was a significant (p < 0.05) increase in the frequency of urination in the 5-hour period after the first dose. There was also a significant (p < 0.001) increase in the excretion ratio in the 5-hour period after the second dose of extract. The third dose failed to change any of the measured parameters. Based on these first human data, T. officinale ethanolic extract shows promise as a diuretic in humans. Further studies are needed to establish the value of this herb for induction of diuresis in human subjects.

A Practical Bayesian Design to Identify the Maximum Tolerated Dose Contour for Drug Combination Trials

PubMed Central

Zhang, Liangcai; Yuan, Ying

2016-01-01

Drug combination therapy has become the mainstream approach to cancer treatment. One fundamental feature that makes combination trials different from single-agent trials is the existence of the maximum tolerated dose (MTD) contour, i.e., multiple MTDs. As a result, unlike single-agent phase I trials, which aim to find a single MTD, it is often of interest to find the MTD contour for combination trials. We propose a new dose-finding design, the waterfall design, to find the MTD contour for drug combination trials. Taking the divide-and-conquer strategy, the waterfall design divides the task of finding the MTD contour into a sequence of one-dimensional dose-finding processes, known as subtrials. The subtrials are conducted sequentially in a certain order, such that the results of each subtrial will be used to inform the design of subsequent subtrials. Such information borrowing allows the waterfall design to explore the two-dimensional dose space efficiently using a limited sample size, and decreases the chance of overdosing and underdosing patients. To accommodate the consideration that doses on the MTD contour may have very different efficacy or synergistic effects due to drug-drug interaction, we further extend our approach to a phase I/II design with the goal of finding the MTD with the highest efficacy. Simulation studies show that the waterfall design is safer and has higher probability of identifying the true MTD contour than some existing designs. The R package “BOIN” to implement the waterfall design is freely available from CRAN. PMID:27580928

Intelligent Pilot Aids for Flight Re-Planning in Emergencies

NASA Technical Reports Server (NTRS)

Pritchett, Amy R.; Ockerman, Jennifer

2005-01-01

Effective and safe control of an aircraft may be difficult or nearly impossible for a pilot following an unexpected system failure. Without prior training, the pilot must ascertain on the fly those changes in both manual control technique and procedures that will lead to a safe landing of the aircraft. Sophisticated techniques for determining the required control techniques are now available. Likewise, a body of literature on pilot decision making provides formalisms for examining how pilots approach discrete decisions framed as the selection between options. However, other aspects of behavior, such as the task of route planning and guidance, are not as well studied. Not only is the pilot faced with possible performance changes to the aircraft dynamics, but he or she is also tasked to create a plan of actions that will effectively take the aircraft down to a safe landing. In this plan, the many actions that the pilot can perform are closely intertwined with the trajectory of the aircraft, making it difficult to accurately predict the final outcome. Coupled with the vast number of potential actions to be taken, this problem may seem intractable. This is reflected in the lack of a pre-specified procedure capable of giving pilots the ability to find a resolution for this task. This report summarizes a multi-year effort to examine methods to aid pilots in planning an approach and arrival to an airport following an aircraft systems failure. Ultimately, we hypothesize that automatic assistance to pilots can be provided in real-time in the form of improving pilot control of a damaged aircraft and providing pilots with procedural directives suitable for critical flight conditions; such systems may also benefit pilot training and procedure design. To achieve this result, a systematic, comprehensive research program was followed, building on prior research. This approach included a pencil-and-paper study with airline pilots examining methods of representing a flight route in an immediately understandable manner, and in a manner that would allow the pilot to modify an automatically-generated route and/or detect any inappropriate elements in an automatically-generated route. Likewise, a flight simulator study examined different cockpit systems for the relative merits of providing pilots with any of a variety of automated functions for emergency flight planning. The results provide specific guidance for the design of such systems.

SU-F-T-117: A Pilot Study of Organ Dose Reconstruction for Wilms Tumor Patients Treated with Radiation Therapy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Makkia, R; Pelletier, C; Jung, J

Purpose: To reconstruct major organ doses for the Wilms tumor pediatric patients treated with radiation therapy using pediatric computational phantoms, treatment planning system (TPS), and Monte Carlo (MC) dose calculation methods. Methods: A total of ten female and male pediatric patients (15–88 months old) were selected from the National Wilms Tumor Study cohort and ten pediatric computational phantoms corresponding to the patient’s height and weight were selected for the organ dose reconstruction. Treatment plans were reconstructed on the computational phantoms in a Pinnacle TPS (v9.10) referring to treatment records and exported into DICOM-RT files, which were then used to generatemore » the input files for XVMC MC code. The mean doses to major organs and the dose received by 50% of the heart were calculated and compared between TPS and MC calculations. The same calculations were conducted by replacing the computational human phantoms with a series of diagnostic patient CT images selected by matching the height and weight of the patients to validate the anatomical accuracy of the computational phantoms. Results: Dose to organs located within the treatment fields from the computational phantoms and the diagnostic patient CT images agreed within 2% for all cases for both TPS and MC calculations. The maximum difference of organ doses was 55.9 % (thyroid), but the absolute dose difference in this case was 0.33 Gy which was 0.96% of the prescription dose. The doses to ovaries and testes from MC in out-of-field provided more discrepancy (the maximum difference of 13.2% and 50.8%, respectively). The maximum difference of the 50% heart volume dose between the phantoms and the patient CT images was 40.0%. Conclusion: This study showed the pediatric computational phantoms are applicable to organ doses reconstruction for the radiotherapy patients whose three-dimensional radiological images are not available.« less

The Effects of Atropine Sulfate on Aviator Performance

DTIC Science & Technology

1985-03-01

and Environmental Medicine , !_6(3), 30*4-308. 8. Asknes, 3. 0. (195*4). Effects of small doses of alcohol upon performance in a Link trainer. Journal...of Aviation Medicine , 25, 680-688. 9.- Henry, P. H., Davis, To Q., Engelken, 3. J.p Triebvasserg Jo H., &Lancaster, M. C. (1974). Alcohol-induced...performance decrements assessed by two Link trainer tasks using experienced pilots. Aerospace Medicine , *45(10), 1180-1189. 10. Henry, P. H., Flueok, J. A

Achieving HIV risk reduction through HealthMpowerment.org, a user-driven eHealth intervention for young Black men who have sex with men and transgender women who have sex with men

PubMed Central

Muessig, Kathryn E.; Baltierra, Nina B.; Pike, Emily C.; LeGrand, Sara; Hightow-Weidman, Lisa B.

2014-01-01

Young, Black men who have sex with men and transgender women who have sex with men (YBMSM/TW) are at disproportionate risk for HIV and other sexually transmitted infections (HIV/STI). HealthMpowerment.org (HMP) is a mobile phone optimised online intervention that utilises behaviour change and gaming theories to reduce risky sexual behaviours and build community among HIV-positive and negative YBMSM/TW. The intervention is user-driven, provides social support, and utilises a point reward system. A four-week pilot trial was conducted with a diverse group of 15 YBMSM/TW. During exit interviews, participants described how HMP components led to behaviour changes such as asking partners' sexual history, increased condom use, and HIV/STI testing. The user-driven structure, interactivity, and rewards appeared to facilitate sustained user engagement and the mobile platform provided relevant information in real-time. Participants described the reward elements of exceeding their previous scores and earning points toward prizes as highly motivating. HMP showed promise for being able to deliver a sufficient intervention dose and we found a trend toward higher dose received and more advanced stages of behaviour change. In this pilot trial, HMP was well accepted and demonstrates promise for translating virtual intervention engagement into actual behaviour change to reduce HIV risk behaviours. PMID:25593616