11. BUOY DECK, NEAR PILOT HOUSE SUPERSTRUCTURE, LOOKING TOWARDS HATCH ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

11. BUOY DECK, NEAR PILOT HOUSE SUPERSTRUCTURE, LOOKING TOWARDS HATCH DOOR INTO WINCH ROOM IN THE SUPERSTRUCTURE (LABELED AT PASSAGE & HYDRAULIC MACHINERY ON PLAN). - U.S. Coast Guard Cutter WHITE HEATH, USGS Integrated Support Command Boston, 427 Commercial Street, Boston, Suffolk County, MA

An open-label pilot study to assess the efficacy and safety of virgin coconut oil in reducing visceral adiposity.

PubMed

Liau, Kai Ming; Lee, Yeong Yeh; Chen, Chee Keong; Rasool, Aida Hanum G

2011-01-01

Introduction. This is an open-label pilot study on four weeks of virgin coconut oil (VCO) to investigate its efficacy in weight reduction and its safety of use in 20 obese but healthy Malay volunteers. Methodology. Efficacy was assessed by measuring weight and associated anthropometric parameters and lipid profile one week before and one week after VCO intake. Safety was assessed by comparing organ function tests one week before and one week after intake of VCO. Paired t-test was used to analyse any differences in all the measurable variables. Results. Only waist circumference (WC) was significantly reduced with a mean reduction of 2.86 cm or 0.97% from initial measurement (P = .02). WC reduction was only seen in males (P < .05). There was no change in the lipid profile. There was a small reduction in creatinine and alanine transferase levels. Conclusion. VCO is efficacious for WC reduction especially in males and it is safe for use in humans.

An Open-Label Pilot Study to Assess the Efficacy and Safety of Virgin Coconut Oil in Reducing Visceral Adiposity

PubMed Central

Liau, Kai Ming; Lee, Yeong Yeh; Chen, Chee Keong; Rasool, Aida Hanum G.

2011-01-01

Introduction. This is an open-label pilot study on four weeks of virgin coconut oil (VCO) to investigate its efficacy in weight reduction and its safety of use in 20 obese but healthy Malay volunteers. Methodology. Efficacy was assessed by measuring weight and associated anthropometric parameters and lipid profile one week before and one week after VCO intake. Safety was assessed by comparing organ function tests one week before and one week after intake of VCO. Paired t-test was used to analyse any differences in all the measurable variables. Results. Only waist circumference (WC) was significantly reduced with a mean reduction of 2.86 cm or 0.97% from initial measurement (P = .02). WC reduction was only seen in males (P < .05). There was no change in the lipid profile. There was a small reduction in creatinine and alanine transferase levels. Conclusion. VCO is efficacious for WC reduction especially in males and it is safe for use in humans. PMID:22164340

Protocol for a pilot randomised controlled trial of an intervention to increase the use of traffic light food labelling in UK shoppers (the FLICC trial).

PubMed

Scarborough, Peter; Hodgkins, Charo; Raats, Monique M; Harrington, Richard A; Cowburn, Gill; Dean, Moira; Doherty, Aiden; Foster, Charlie; Juszczak, Edmund; Matthews, Anne; Mizdrak, Anja; Mhurchu, Cliona Ni; Shepherd, Richard; Tiomotijevic, Lada; Winstone, Naomi; Rayner, Mike

2015-01-01

Traffic light labelling of foods-a system that incorporates a colour-coded assessment of the level of total fat, saturated fat, sugar and salt on the front of packaged foods-has been recommended by the UK Government and is currently in use or being phased in by many UK manufacturers and retailers. This paper describes a protocol for a pilot randomised controlled trial of an intervention designed to increase the use of traffic light labelling during real-life food purchase decisions. The objectives of this two-arm randomised controlled pilot trial are to assess recruitment, retention and data completion rates, to generate potential effect size estimates to inform sample size calculations for the main trial and to assess the feasibility of conducting such a trial. Participants will be recruited by email from a loyalty card database of a UK supermarket chain. Eligible participants will be over 18 and regular shoppers who frequently purchase ready meals or pizzas. The intervention is informed by a review of previous interventions encouraging the use of nutrition labelling and the broader behaviour change literature. It is designed to impact on mechanisms affecting belief and behavioural intention formation as well as those associated with planning and goal setting and the adoption and maintenance of the behaviour of interest, namely traffic light label use during purchases of ready meals and pizzas. Data will be collected using electronic sales data via supermarket loyalty cards and web-based questionnaires and will be used to estimate the effect of the intervention on the nutrition profile of purchased ready meals and pizzas and the behavioural mechanisms associated with label use. Data collection will take place over 48 weeks. A process evaluation including semi-structured interviews and web analytics will be conducted to assess feasibility of a full trial. The design of the pilot trial allows for efficient recruitment and data collection. The intervention could be generalised to a wider population if shown to be feasible in the main trial. ISRCTN: ISRCTN19316955.

Off-label and unlicensed drug use in hospitalized newborns in a Saudi tertiary care hospital: a cohort study.

PubMed

Mazhar, Faizan; Akram, Shahzad; Haider, Nafis; Hadi, Muhammad Abdul; Sultana, Jabeen

2018-06-01

Objective To determine the extent of off-label and unlicensed prescribing in hospitalized newborns and to identify patient-related risk factors associated with off-label prescribing. Methods A prospective cohort study was conducted between January and March 2016 at a neonatology department of a tertiary-care hospital in the Eastern province. All consecutive admissions to all neonatal care levels meeting the inclusion and exclusion criteria were eligible for enrollment. All prescriptions were classified as off-label or unlicensed according to drug product monograph. Clinical and prescription data were extracted using a pilot-tested structured data collection sheet. Results During the study period 583 prescriptions were made for 138 newborns, of which 29.7% (173/583) and 12.9% (75/583) were classified as off-label and unlicensed drugs respectively for use in neonates. Thirty-four percent (47/138) of patients received at least one off-label/unlicensed medicine. Mechanical ventilation, admission to the neonatal intensive care unit and length of hospital stay were identified as independent risk factors associated with prescribing of at least one off-label medication. Conclusion Use of off-label and unlicensed drugs in hospitalized newborns seems to be a common practice in this Saudi hospital. Future research should evaluate safety and efficacy of off-label and/or unlicensed use of drugs in neonates.

Parental Involvement in Language and Literacy Acquisition: A Bilingual Journaling Approach

ERIC Educational Resources Information Center

Caesar, Lena G.; Nelson, Nickola Wolf

2014-01-01

This pilot study examined the feasibility of a home-school partnership for improving emergent literacy skills in Spanish-speaking pre-school children of migrant farmworkers. Parents were requested to send labeled drawings of family activities to their children's classroom for supplementing bilingual language and literacy instruction. Participants…

Where have all the pilot studies gone? A follow-up on 30 years of pilot studies in Clinical Rehabilitation

PubMed Central

Kaur, Navaldeep; Figueiredo, Sabrina; Bouchard, Vanessa; Moriello, Carolina; Mayo, Nancy

2017-01-01

Introduction: Pilot studies are meritorious for determining the feasibility of a definitive clinical trial in terms of conduct and potential for efficacy, but their possible applications for planning a future trial are not always fully realized. The purpose of this review was to estimate the extent to which pilot/feasibility studies: (i) addressed needed objectives; (ii) led to definitive trials; and (iii) whether the subsequent undertaking of a definitive trial was influenced by the strength of the evidence of outcome improvement. Methods: Trials published in the journal Clinical Rehabilitation, since its inception, were eligible if the word ‘pilot’ or ‘feasibility’ was specified somewhere in the article. A total of 191 studies were reviewed, results were summarized descriptively, and between-group effect sizes were computed. Results: The specific purposes of piloting were stated in only 58% (n = 110) of the studies. The most frequent purpose was to estimate the potential for efficacy (85%), followed by testing the feasibility of the intervention (60%). Only 12% of the studies were followed by a definitive trial; <4% of studies had a main study underway or a published study protocol. There was no relationship between observed effect size and follow-up of pilot studies, although the confidence intervals were very wide owing to small number of trials that followed on. Discussion: Labelling and reporting of pilot studies needs to be improved to be concordant with the recently issued CONSORT guidelines. Feasibility needs to be fully tested and demonstrated prior to committing considerable human and monetary resources. PMID:28786333

11. BUOY DECK, NEAR PILOT HOUSE SUPERSTRUCTURE, LOOKING TOWARDS HATCH ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

11. BUOY DECK, NEAR PILOT HOUSE SUPERSTRUCTURE, LOOKING TOWARDS HATCH DOOR INTO WINCH ROOM IN THE SUPERSTRUCTURE (LABELED AS FASSAGE & HYDRAULIC MACHINERY ON PLAN), SHOWING UNDERSIDE OF GEARED WHEEL OF BOOM. - U.S. Coast Guard Cutter WHITE LUPINE, U.S. Coast Guard Station Rockland, east end of Tillson Avenue, Rockland, Knox County, ME

Sissies, Mama's Boys, and Tomboys: Is Children's Gender Nonconformity More Acceptable When Nonconforming Traits Are Positive?

PubMed

Coyle, Emily F; Fulcher, Megan; Trübutschek, Darinka

2016-10-01

The evaluation of gender nonconformity in children was examined in two studies. In Study 1, 48 young adults evaluated the positivity of culturally popular labels for gender nonconformity, including "tomboy," "sissy," and two new labels generated in a pilot study, "mama's boy" and "brat." The "mama's boy" was described as a boy who has positive feminine traits (gentle and well-mannered) as opposed to the "sissy" who was described as having negative feminine traits (crying and easily frightened). In Study 2, 161 young adults read descriptions of gender-typical and nonconforming children, evaluating them in several domains. The label "mama's boy" was considered negative in Study 1 but an unlabeled positive nonconforming boy was rated as likable and competent in Study 2. However, participants worried about nonconforming boys, saying they would encourage them to behave differently and describing such children with derogatory sexual orientation slurs. "Tomboy" was generally considered a positive label in Study 1. In Study 2, gender nonconforming girls were considered neither likable nor dislikeable, and neither competent nor incompetent, reflecting ambivalence about girls' nonconformity. It may be that we use gender nonconformity labels as indicators of sexual orientation, even in young children. Therefore, even when an individual displays objectively positive traits, the stigma associated with homosexuality taints judgments about their nonconforming behavior.

Effect of the Probiotic Saccharomyces boulardii on Cholesterol and Lipoprotein Particles in Hypercholesterolemic Adults: A Single-Arm, Open-Label Pilot Study.

PubMed

Ryan, Jennifer Joan; Hanes, Douglas Allen; Schafer, Morgan Beth; Mikolai, Jeremy; Zwickey, Heather

2015-05-01

Elevated blood cholesterol levels are a major risk factor for coronary artery disease, the leading cause of death worldwide. Probiotics have been investigated as potential cholesterol-lowering therapies, but no previous studies have assessed the effect of the probiotic yeast Saccharomyces boulardii on cholesterol levels in human volunteers. The objective of this study was to examine the effect of S. boulardii on serum cholesterol and lipoprotein particles in hypercholesterolemic adults. This study was a single-arm, open-label pilot study. Twelve hypercholesterolemic participants were recruited into the study; one dropped out. Participants took 5.6×10(10) colony forming unit (CFU) encapsulated S. boulardii (Saccharomyces cerevisiae var. boulardii CNCM I-1079) twice daily for an 8-week period. Fasting concentrations of cholesterol (total cholesterol, low-density lipoprotein-cholesterol [LDL-C], high-density lipoprotein-cholesterol [HDL-C], and triglycerides), lipoprotein particles (very-low-density lipoprotein-particle [VLDL-P], remnant lipoprotein particle [RLP-P], total LDL-P, LDL III-P, LDL IV-P, total HDL-P, and HDL 2b-P), and additional cardiovascular biomarkers (apo B-100, lipoprotein [a], high-sensitivity C-reactive protein, homocysteine, fibrinogen, and insulin) were measured at baseline, after 4 weeks, and after 8 weeks. Remnant lipoprotein particles decreased by 15.5% (p=0.03) over the 8-week period. The remaining outcome measures were not significantly altered. In this pilot study, 8 weeks of daily supplementation with S. boulardii lowered remnant lipoprotein, a predictive biomarker and potential therapeutic target in the treatment and prevention of coronary artery disease.

Lacosamide for uncontrolled primary generalized tonic-clonic seizures: An open-label pilot study with 59-week extension.

PubMed

Wechsler, Robert T; Yates, Stephen L; Messenheimer, John; Leroy, Robert; Beller, Cynthia; Doty, Pamela

2017-02-01

Assess the safety of adjunctive lacosamide for the treatment of uncontrolled primary generalized tonic-clonic seizures in patients (16-65 years) with primary generalized (genetic) epilepsy (PGE). An open-label pilot safety study (SP0961; NCT01118949), comprising 12 weeks' historical baseline, 4 weeks' prospective baseline, 3 weeks' titration (target: 400mg/day adjunctive lacosamide) and 6 weeks' maintenance. Patients who continued to the extension study (SP0962; NCT01118962) then received ≤59 weeks of flexible treatment (100-800mg/day lacosamide with flexible dosing of concomitant antiepileptic drugs). The primary outcomes for SP0961 were the mean change (±standard deviation) in absence seizure or myoclonic seizure days per 28days from prospective baseline to maintenance; for SP0962, the incidence of treatment-emergent adverse events (TEAEs) and withdrawals because of TEAEs. Of the 49 patients who enrolled, 40 (82%) completed the pilot study and 9 discontinued (5 because of adverse events). Of the 39 patients who continued to the extension study, 10 discontinued (2 owing to TEAEs) and 29 (74%) completed the study. During the pilot study, patients reported a reduction in mean (±standard deviation) absence and myoclonic seizure days per 28days (-0.37±4.80, -2.19±5.80). Reductions were also observed during the extension study (-2.38±5.54, -2.78±6.43). Five patients in SP0961 and 2 patients in SP0962 experienced TEAEs of new or increased frequency of absence seizures or myoclonic seizures. The most common TEAEs during SP0961 were dizziness (39%) and nausea (27%), and during SP0962 were dizziness (26%) and upper respiratory tract infection (26%). The safety profile of adjunctive lacosamide was similar to that previously published. Adjunctive lacosamide did not systematically worsen absence or myoclonic seizures, and appears to be well tolerated in patients with PGE. Copyright © 2016. Published by Elsevier B.V.

Promoting Healthy Eating and Exercise through Online Messages: A Pilot Study

ERIC Educational Resources Information Center

Nyquist, Helen; Rhee, Yeong; Brunt, Ardith; Garden-Robinson, Julie

2011-01-01

The effectiveness of online messages to change dietary intake and level of physical activity was assessed. Thirty-six volunteers completed a 26-item pre- and post-intervention online survey and received a total of 36 email messages about MyPyramid, food labels, healthier lifestyles, and physical activity. Participants reported increased fiber…

Adapting Web content for low-literacy readers by using lexical elaboration and named entities labeling

NASA Astrophysics Data System (ADS)

Watanabe, W. M.; Candido, A.; Amâncio, M. A.; De Oliveira, M.; Pardo, T. A. S.; Fortes, R. P. M.; Aluísio, S. M.

2010-12-01

This paper presents an approach for assisting low-literacy readers in accessing Web online information. The "Educational FACILITA" tool is a Web content adaptation tool that provides innovative features and follows more intuitive interaction models regarding accessibility concerns. Especially, we propose an interaction model and a Web application that explore the natural language processing tasks of lexical elaboration and named entity labeling for improving Web accessibility. We report on the results obtained from a pilot study on usability analysis carried out with low-literacy users. The preliminary results show that "Educational FACILITA" improves the comprehension of text elements, although the assistance mechanisms might also confuse users when word sense ambiguity is introduced, by gathering, for a complex word, a list of synonyms with multiple meanings. This fact evokes a future solution in which the correct sense for a complex word in a sentence is identified, solving this pervasive characteristic of natural languages. The pilot study also identified that experienced computer users find the tool to be more useful than novice computer users do.

Continuing weight-loss effect after topiramate discontinuation in obese persons with schizophrenia: a pilot open-label study.

PubMed

Liang, C-S; Yang, F-W; Huang, S-Y; Ho, P-S

2014-07-01

Few studies have investigated the likelihood of weight maintenance in obese persons with schizophrenia after their initial successful weight loss. This pilot open-label study examined the efficacy of topiramate in weight loss and the trajectory of weight changes after topiramate discontinuation. This study enrolled 10 obese persons with schizophrenia. A 4-month treatment phase was started, followed by a 12-month discontinuation phase. Body weight was measured as the primary outcome every month. Secondary outcomes included leptin levels, fasting glucose, lipid profiles, and insulin resistance index. After the 4-month addition of topiramate, participants lost 1.79 kg of their body weight (95% CI=-3.03 to -0.56, p=0.005). The maximum weight reduction was 4.32 kg, occurring when topiramate had been discontinued for 12 months (95% CI=-6.41 to -2.24, p<0.001). The continuing weight-loss effect after topiramate discontinuation might have resulted from topiramate's potential to improve leptin functioning. These findings demonstrate that topiramate's weight-loss effect could not only persist during its administration, but also continue to improve after its discontinuation. © Georg Thieme Verlag KG Stuttgart · New York.

Nutrition labeling and value size pricing at fast-food restaurants: a consumer perspective.

PubMed

O'Dougherty, Maureen; Harnack, Lisa J; French, Simone A; Story, Mary; Oakes, J Michael; Jeffery, Robert W

2006-01-01

This pilot study examined nutrition-related attitudes that may affect food choices at fast-food restaurants, including consumer attitudes toward nutrition labeling of fast foods and elimination of value size pricing. A convenience sample of 79 fast-food restaurant patrons aged 16 and above (78.5% white, 55% female, mean age 41.2 [17.1]) selected meals from fast-food restaurant menus that varied as to whether nutrition information was provided and value pricing included and completed a survey and interview on nutrition-related attitudes. Only 57.9% of participants rated nutrition as important when buying fast food. Almost two thirds (62%) supported a law requiring nutrition labeling on restaurant menus. One third (34%) supported a law requiring restaurants to offer lower prices on smaller instead of bigger-sized portions. This convenience sample of fast-food patrons supported nutrition labels on menus. More research is needed with larger samples on whether point-of-purchase nutrition labeling at fast-food restaurants raises perceived importance of nutrition when eating out.

Prospective trial of an herbal formula BYSH and Saw palmetto in patients with hormonal refractory prostate cancer: a pilot study.

PubMed

Ng, Anthony C-F; Cheng, K-F; Leung, P-C

2014-01-01

BYSH, a herbal formula, was evaluated for efficacy and safety in a pilot study for patients with advanced hormone refractory prostate cancer (HRPC). The pilot study was designed as a single-center open-label trial. Patients with HRPC were treated with BYSH for 24 weeks. The primary end point was the changes in serum prostate-specific antigen (PSA) level. Safety parameters such as liver and renal functions were monitored during the study period. Ten patients were eligible for the study. Most of them had stable PSA levels while taking BYSH. However, at the end of the BYSH treatment, the level of PSA increased. The median survival from diagnosis of HRPC was 16.4 months. Liver and renal functions remained normal. BYSH was well tolerated and no patient reported adverse events during the study period. Although it is inappropriate to make a conclusion based on the pilot study results, the trend of improvement is obvious. Further investigations should be conducted to demonstrate its clinical benefits. We have also briefly reviewed some plant products which are patented and also available in market.

Global combined precursor isotopic labeling and isobaric tagging (cPILOT) approach with selective MS(3) acquisition.

PubMed

Evans, Adam R; Robinson, Renã A S

2013-11-01

Recently, we reported a novel proteomics quantitation scheme termed "combined precursor isotopic labeling and isobaric tagging (cPILOT)" that allows for the identification and quantitation of nitrated peptides in as many as 12-16 samples in a single experiment. cPILOT offers enhanced multiplexing and posttranslational modification specificity, however excludes global quantitation for all peptides present in a mixture and underestimates reporter ion ratios similar to other isobaric tagging methods due to precursor co-isolation. Here, we present a novel chemical workflow for cPILOT that can be used for global tagging of all peptides in a mixture. Specifically, through low pH precursor dimethylation of tryptic or LysC peptides followed by high pH tandem mass tags, the same reporter ion can be used twice in a single experiment. Also, to improve triple-stage mass spectrometry (MS(3) ) data acquisition, a selective MS(3) method that focuses on product selection of the y1 fragment of lysine-terminated peptides is incorporated into the workflow. This novel cPILOT workflow has potential for global peptide quantitation that could lead to enhanced sample multiplexing and increase the number of quantifiable spectra obtained from MS(3) acquisition methods. © 2013 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

[Usage of food and beverage labels by supermarket shoppers in Brasilia, Brazil].

PubMed

Monteiro, Renata Alves; Coutinho, Janine Giuberti; Recine, Elisabetta

2005-09-01

To investigate whether adults who shop in supermarkets in one part of Brasilia, the capital city of Brazil, use the information contained in food and beverage labels, as well as to characterize this usage. This study was done in five supermarkets in the Plano Piloto (Pilot Plan) central core area of Brasilia. The research was carried out in two stages: (1) a quantitative stage, based on a cross-sectional study, during which 250 individuals were randomly selected and surveyed in the supermarkets; and (2) a qualitative stage, in which 25 individuals who had participated in the first stage underwent more extensive individual interviews. Of the 250 persons surveyed, 187 of them (74.8%) reported that they usually read food and beverage labels. However, only 25.7% of the consumers who consulted the labels did so for all foods and beverages. Of the persons who read the labels, the majority (59.9%) only read the labels for specific foods, including milk, dairy products, canned foods, sausages, and diet products. The information that shoppers most often wanted to know from the labels was the number of calories and the fat and sodium content. Our study shows the need to utilize our findings in improving the existing educational strategies for promoting healthy eating. We suggest that consumers, food producers, and food distributors all be involved in developing strategies for nutrition education.

Validation of laboratory-scale recycling test method of paper PSA label products

Treesearch

Carl Houtman; Karen Scallon; Richard Oldack

2008-01-01

Starting with test methods and a specification developed by the U.S. Postal Service (USPS) Environmentally Benign Pressure Sensitive Adhesive Postage Stamp Program, a laboratory-scale test method and a specification were developed and validated for pressure-sensitive adhesive labels, By comparing results from this new test method and pilot-scale tests, which have been...

The effect of polycarbophil gel (Replens) on bacterial vaginosis: a pilot study.

PubMed

Wu, Justine P; Fielding, Stephen L; Fiscella, Kevin

2007-01-01

To determine if use of intravaginal polycarbophil gel (Replens) for 1 month will: (1) lower vaginal pH; (2) improve signs of bacterial vaginosis (BV). Seventeen women with BV self-administered polycarbophil gel every third day for 4 weeks in an open-label, prospective pilot study. Primary outcome measures included vaginal pH, presence of amines and Nugent scores. At week 4, there was improvement in Nugent scores, vaginal odor and clue cell count (p<0.05). Eleven women converted from amine positive to negative (73+/-20%). There was no significant change in vaginal pH. Polycarbophil gel is associated with improved signs of BV, although not vaginal pH.

A Pilot Study of Naltrexone and BASICS for Heavy Drinking Young Adults

PubMed Central

Leeman, Robert F.; Palmer, Rebekka S.; Corbin, William R.; Romano, Denise M.; Meandzija, Boris; O’Malley, Stephanie S.

2008-01-01

Heavy drinking young adults often have limited motivation to change their drinking behavior. Adding pharmacotherapy to brief counseling is a novel approach to treating this population. A small open-label pilot study was conducted to assess the feasibility of offering eight weeks of daily and targeted (i.e., taken as needed in anticipation of drinking) naltrexone with BASICS (brief motivational) counseling to heavy drinking young adults; to assess the tolerability of the medication in this population and to obtain preliminary efficacy data. The sample (N = 14) showed strong adherence to study appointments and medication taking, supporting the feasibility of this approach. Overall, the medication was well-tolerated. Significant reductions from baseline were observed in drinks per drinking day and in percent heavy drinking days and these gains were maintained one month after treatment ended. A significant decrease in alcohol-related consequences was also observed. Findings from this small pilot study suggest that naltrexone in combination with BASICS represents a promising strategy to reduce heavy drinking among young adults. PMID:18502591

Teaching the Meaning of Words to Children with Visual Impairments

ERIC Educational Resources Information Center

Vervloed, Mathijs P. J.; Loijens, Nancy E. A.; Waller, Sarah E.

2014-01-01

In the report presented here, the authors describe a pilot intervention study that was intended to teach children with visual impairments the meaning of far-away words, and that used their mothers as mediators. The aim was to teach both labels and deep word knowledge, which is the comprehension of the full meaning of words, illustrated through…

Effect of Aromatherapy Massage on Chemotherapy-Induced Peripheral Neuropathic Pain and Fatigue in Patients Receiving Oxaliplatin: An Open Label Quasi-Randomized Controlled Pilot Study.

PubMed

Izgu, Nur; Ozdemir, Leyla; Bugdayci Basal, Fatma

2017-12-02

Patients receiving oxaliplatin may experience peripheral neuropathic pain and fatigue. Aromatherapy massage, a nonpharmacological method, may help to control these symptoms. The aim of this open-label, parallel-group, quasi-randomized controlled pilot study was to investigate the effect of aromatherapy massage on chemotherapy-induced peripheral neuropathic pain and fatigue in patients receiving oxaliplatin. Stratified randomization was used to allocate 46 patients to 2 groups: intervention (n = 22) and control (n = 24). Between week 1 and week 6, participants in the intervention group (IG) received aromatherapy massage 3 times a week. There was no intervention in weeks 7 and 8. The control group (CG) received routine care. Neuropathic pain was identified using the Douleur Neuropathique 4 Questions; severity of painful paresthesia was assessed with the numerical rating scale; fatigue severity was identified with the Piper Fatigue Scale. At week 6, the rate of neuropathic pain was significantly lower in the IG, when compared with the CG. The severity of painful paresthesia based on numerical rating scale in the IG was significantly lower than that in the CG at weeks 2, 4, and 6. At week 8, fatigue severity in the IG was significantly lower when compared with CG (P < .05). Aromatherapy massage may be useful in the management of chemotherapy-induced peripheral neuropathic pain and fatigue. This pilot study suggests that aromatherapy massage may be useful to relieve neuropathic pain and fatigue. However, there is a need for further clinical trials to validate the results of this study.

Spontaneous labelling and stigma associated with clinical characteristics of peers 'at-risk' for psychosis.

PubMed

Anglin, Deidre M; Greenspoon, Michelle I; Lighty, Quenesha; Corcoran, Cheryl M; Yang, Lawrence H

2014-08-01

The public health benefits of utilizing an 'at-risk for psychosis' designation are tempered by concerns about stigma. It is therefore of interest to examine whether symptoms associated with this designation might spontaneously induce labels associated with a psychotic disorder, other non-psychotic disorders or non-psychiatric labels. This pilot study explored the labels associated with characteristics of 'high risk for psychosis' and the corresponding stigma level. A vignette describing an identical character, followed by a series of questions about stigmatizing attitudes towards the vignette character, was administered in the present investigation. The results indicated that even though most young people (59%) did not spontaneously label the vignette character with psychotic-like diagnostic labels, the single most frequent label provided was 'paranoid/a'. When such labelling, that is, strongly tied to psychosis, occurred, respondents exhibited stronger stigmatizing attributions of fear compared to those indicating non-psychiatric labels (e.g. 'weird'). These results suggest that the majority of respondents did not endorse diagnostic labels spontaneously, thus signaling that stigma in the majority of cases would not naturalistically be elicited. However, a segment of respondents evidenced stigma simply from behavioural changes manifested by individuals exhibiting signs of psychosis, independent of diagnosis. Implications for reducing any stigma associated with an 'at-risk for psychosis' designation are discussed. © 2013 Wiley Publishing Asia Pty Ltd.

AgRISTARS: Foreign commodity production forecasting. The 1980 US corn and soybeans exploratory experiment

NASA Technical Reports Server (NTRS)

Malin, J. T.; Carnes, J. G. (Principal Investigator)

1981-01-01

The U.S. corn and soybeans exploratory experiment is described which consisted of evaluations of two technology components of a production forecasting system: classification procedures (crop labeling and proportion estimation at the level of a sampling unit) and sampling and aggregation procedures. The results from the labeling evaluations indicate that the corn and soybeans labeling procedure works very well in the U.S. corn belt with full season (after tasseling) LANDSAT data. The procedure should be readily adaptable to corn and soybeans labeling required for subsequent exploratory experiments or pilot tests. The machine classification procedures evaluated in this experiment were not effective in improving the proportion estimates. The corn proportions produced by the machine procedures had a large bias when the bias correction was not performed. This bias was caused by the manner in which the machine procedures handled spectrally impure pixels. The simulation test indicated that the weighted aggregation procedure performed quite well. Although further work can be done to improve both the simulation tests and the aggregation procedure, the results of this test show that the procedure should serve as a useful baseline procedure in future exploratory experiments and pilot tests.

Understanding Medication Schedules: Do Pictograms Help?

PubMed

Leong, Madeline; Tam, Vernissia; Xu, Timothy; Peters, Matthew

2018-06-01

Previous studies suggest that pictograms may improve patients' understanding of medication schedules. Understanding a medication schedule is a necessary first step for medication adherence. This study aimed to determine if pictograms improved patients' ability to correctly fill a pillbox. This is a randomized, controlled, crossover pilot study. This study involves 30 patients on the medical wards of an urban, tertiary care center. The PillBox Test required participants to fill a 7-day pillbox with pill-sized colored beads. Participants were randomized to either the control or the experimental condition first. In the control condition, a standard pillbox was used with text instructions on the pill bottles. In the experimental condition, a pictogram pillbox was used with text and pictogram instructions on the pill bottles. There was no significant difference in passing on text or pictogram PillBox Test based on the order of group administration. However, 77% of participants reported that pictograms helped them understand medication instructions, 67% of participants preferred pictograms, and 93% felt pictograms should be used on all medication labels. In this pilot study, the use of pictograms did not significantly improve participants' ability to correctly fill a pillbox. However, most participants preferred pictograms to text labels. Further research is needed to determine the efficacy of pictograms in specific populations.

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.

Hip Hop HEALS: Pilot Study of a Culturally Targeted Calorie Label Intervention to Improve Food Purchases of Children.

PubMed

Williams, Olajide; DeSorbo, Alexandra; Sawyer, Vanessa; Apakama, Donald; Shaffer, Michele; Gerin, William; Noble, James

2016-02-01

We explored the effect of a culturally targeted calorie label intervention on food purchasing behavior of elementary school students. We used a quasi-experimental design with two intervention schools and one control school to assess food purchases of third through fifth graders at standardized school food sales before and after the intervention (immediate and delayed) in schools. The intervention comprised three 1-hour assembly-style hip-hop-themed multimedia classes. A mean total of 225 children participated in two baseline preintervention sales with and without calorie labels; 149 children participated in immediate postintervention food sales, while 133 children participated in the delayed sales. No significant change in purchased calories was observed in response to labels alone before the intervention. However, a mean decline in purchased calories of 20% (p < .01) and unhealthy foods (p < .01) was seen in immediately following the intervention compared to baseline purchases, and this persisted without significant decay after 7 days and 12 days. A 3-hour culturally targeted calorie label intervention may improve food-purchasing behavior of children. © 2015 Society for Public Health Education.

Examining the effectiveness of an intensive, 2-week treatment program for military personnel and veterans with PTSD: Results of a pilot, open-label, prospective cohort trial.

PubMed

Bryan, Craig J; Leifker, Feea R; Rozek, David C; Bryan, AnnaBelle O; Reynolds, Mira L; Oakey, D Nicolas; Roberge, Erika

2018-06-19

This study aimed to examine the effectiveness of cognitive processing therapy (CPT) for posttraumatic stress disorder (PTSD) when administered on a daily basis during a 2-week period of time. In an open-label, prospective cohort pilot trial, 20 U.S. military personnel and veterans diagnosed with PTSD or subthreshold PTSD participated in 12 daily sessions of CPT. Primary outcomes included Clinician Administered PTSD Scale for DSM-5 and PTSD Checklist for DSM-5 scores. Secondary outcomes included Patient Health Questionnaire-8 and Beck Scale for Suicide Ideation (BSSI) scores. Interviews and self-report scales were completed at pretreatment, posttreatment, and 6 months after the treatment. Relative to baseline, PTSD symptom severity and rates of PTSD diagnosis were significantly reduced at posttreatment and 6-month follow-up. Depression symptom severity did not significantly improve, but suicide ideation significantly decreased at 6-month follow-up. Daily administration of CPT is associated with significant reductions in PTSD and suicide ideation. © 2018 Wiley Periodicals, Inc.

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

The Effects of Orally Administered Beta-Glucan on Innate Immune Responses in Humans, a Randomized Open-Label Intervention Pilot-Study

PubMed Central

Leentjens, Jenneke; Quintin, Jessica; Gerretsen, Jelle; Kox, Matthijs; Pickkers, Peter; Netea, Mihai G.

2014-01-01

Rationale To prevent or combat infection, increasing the effectiveness of the immune response is highly desirable, especially in case of compromised immune system function. However, immunostimulatory therapies are scarce, expensive, and often have unwanted side-effects. β-glucans have been shown to exert immunostimulatory effects in vitro and in vivo in experimental animal models. Oral β-glucan is inexpensive and well-tolerated, and therefore may represent a promising immunostimulatory compound for human use. Methods We performed a randomized open-label intervention pilot-study in 15 healthy male volunteers. Subjects were randomized to either the β -glucan (n = 10) or the control group (n = 5). Subjects in the β-glucan group ingested β-glucan 1000 mg once daily for 7 days. Blood was sampled at various time-points to determine β-glucan serum levels, perform ex vivo stimulation of leukocytes, and analyze microbicidal activity. Results β-glucan was barely detectable in serum of volunteers at all time-points. Furthermore, neither cytokine production nor microbicidal activity of leukocytes were affected by orally administered β-glucan. Conclusion The present study does not support the use of oral β-glucan to enhance innate immune responses in humans. Trial Registration ClinicalTrials.gov NCT01727895 PMID:25268806

Evaluating language environment analysis system performance for Chinese: a pilot study in Shanghai.

PubMed

Gilkerson, Jill; Zhang, Yiwen; Xu, Dongxin; Richards, Jeffrey A; Xu, Xiaojuan; Jiang, Fan; Harnsberger, James; Topping, Keith

2015-04-01

The purpose of this study was to evaluate performance of the Language Environment Analysis (LENA) automated language-analysis system for the Chinese Shanghai dialect and Mandarin (SDM) languages. Volunteer parents of 22 children aged 3-23 months were recruited in Shanghai. Families provided daylong in-home audio recordings using LENA. A native speaker listened to 15 min of randomly selected audio samples per family to label speaker regions and provide Chinese character and SDM word counts for adult speakers. LENA segment labeling and counts were compared with rater-based values. LENA demonstrated good sensitivity in identifying adult and child; this sensitivity was comparable to that of American English validation samples. Precision was strong for adults but less so for children. LENA adult word count correlated strongly with both Chinese characters and SDM word counts. LENA conversational turn counts correlated similarly with rater-based counts after the exclusion of three unusual samples. Performance related to some degree to child age. LENA adult word count and conversational turn provided reasonably accurate estimates for SDM over the age range tested. Theoretical and practical considerations regarding LENA performance in non-English languages are discussed. Despite the pilot nature and other limitations of the study, results are promising for broader cross-linguistic applications.

Rotigotine Objectively Improves Sleep in Parkinson's Disease: An Open-Label Pilot Study with Actigraphic Recording.

PubMed

Calandra-Buonaura, Giovanna; Guaraldi, Pietro; Doria, Andrea; Zanigni, Stefano; Nassetti, Stefania; Favoni, Valentina; Cevoli, Sabina; Provini, Federica; Cortelli, Pietro

2016-01-01

Sleep disturbances represent important predictors of poor quality of life (QoL) in Parkinson's disease (PD). This open-label pilot study aimed to objectively assess, by means of actigraphic recording, effect of rotigotine on sleep in PD patients with self-reported sleep complaints. 15 PD patients underwent one-week actigraphic recording before (T0) and during (T1) rotigotine treatment, which was titrated to the dose subjectively improving motor symptoms (4-8 mg/24 h). Sleep disturbances, daytime sleepiness, cognitive performance, QoL, and depression were also evaluated with questionnaires. Actigraphic recordings showed a significant reduction in nocturnal motor activity and mean duration of wake episodes after sleep onset during rotigotine treatment compared to baseline. In 10 patients presenting objective evidence of poor sleep quality at T0 (sleep efficiency ≤ 85%), rotigotine also significantly improved other sleep parameters and further reduced nocturnal motor activity and mean duration of wake episodes. A significant decrease in number and duration of daytime sleep episodes was also observed at T1. Finally we confirmed that rotigotine significantly improves perceived sleep quality and QoL. Our study showed for the first time that rotigotine is associated with an objective improvement of nocturnal and diurnal sleep disturbances in PD patients with self-reported sleep complaints. This study is registered with AIFA-observational study registry number 12021.

Renal blood flow using arterial spin labelling MRI and calculated filtration fraction in healthy adult kidney donors Pre-nephrectomy and post-nephrectomy.

PubMed

Cutajar, Marica; Hilton, Rachel; Olsburgh, Jonathon; Marks, Stephen D; Thomas, David L; Banks, Tina; Clark, Christopher A; Gordon, Isky

2015-08-01

Renal plasma flow (RPF) (derived from renal blood flow, RBF) and glomerular filtration rate (GFR) allow the determination of the filtration fraction (FF), which may have a role as a non-invasive renal biomarker. This is a hypothesis-generating pilot study assessing the effect of nephrectomy on renal function in healthy kidney donors. Eight living kidney donors underwent arterial spin labelling (ASL) magnetic resonance imaging (MRI) and GFR measurement prior to and 1 year after nephrectomy. Chromium-51 labelled ethylenediamine tetraacetic acid ((51)Cr-EDTA) with multi-blood sampling was undertaken and GFR calculated. The RBF and GFR obtained were used to calculate FF. All donors showed an increase in single kidney GFR of 24 - 75 %, and all but two showed an increase in FF (-7 to +52 %) after nephrectomy. The increase in RBF, and hence RPF, post-nephrectomy was not as great as the increase in GFR in seven out of eight donors. As with any pilot study, the small number of donors and their relatively narrow age range are potential limiting factors. The ability to measure RBF, and hence RPF, non-invasively, coupled with GFR measurement, allows calculation of FF, a biomarker that might provide a sensitive indicator of loss of renal reserve in potential donors. • Non-invasive MRI measured renal blood flow and calculated renal plasma flow. • Effect of nephrectomy on blood flow and filtration in donors is presented. • Calculated filtration fraction may be a useful new kidney biomarker.

Dynamic enhancement of drug product labels to support drug safety, efficacy, and effectiveness.

PubMed

Boyce, Richard D; Horn, John R; Hassanzadeh, Oktie; Waard, Anita de; Schneider, Jodi; Luciano, Joanne S; Rastegar-Mojarad, Majid; Liakata, Maria

2013-01-26

Out-of-date or incomplete drug product labeling information may increase the risk of otherwise preventable adverse drug events. In recognition of these concerns, the United States Federal Drug Administration (FDA) requires drug product labels to include specific information. Unfortunately, several studies have found that drug product labeling fails to keep current with the scientific literature. We present a novel approach to addressing this issue. The primary goal of this novel approach is to better meet the information needs of persons who consult the drug product label for information on a drug's efficacy, effectiveness, and safety. Using FDA product label regulations as a guide, the approach links drug claims present in drug information sources available on the Semantic Web with specific product label sections. Here we report on pilot work that establishes the baseline performance characteristics of a proof-of-concept system implementing the novel approach. Claims from three drug information sources were linked to the Clinical Studies, Drug Interactions, and Clinical Pharmacology sections of the labels for drug products that contain one of 29 psychotropic drugs. The resulting Linked Data set maps 409 efficacy/effectiveness study results, 784 drug-drug interactions, and 112 metabolic pathway assertions derived from three clinically-oriented drug information sources (ClinicalTrials.gov, the National Drug File - Reference Terminology, and the Drug Interaction Knowledge Base) to the sections of 1,102 product labels. Proof-of-concept web pages were created for all 1,102 drug product labels that demonstrate one possible approach to presenting information that dynamically enhances drug product labeling. We found that approximately one in five efficacy/effectiveness claims were relevant to the Clinical Studies section of a psychotropic drug product, with most relevant claims providing new information. We also identified several cases where all of the drug-drug interaction claims linked to the Drug Interactions section for a drug were potentially novel. The baseline performance characteristics of the proof-of-concept will enable further technical and user-centered research on robust methods for scaling the approach to the many thousands of product labels currently on the market.

Dynamic enhancement of drug product labels to support drug safety, efficacy, and effectiveness

PubMed Central

2013-01-01

Out-of-date or incomplete drug product labeling information may increase the risk of otherwise preventable adverse drug events. In recognition of these concerns, the United States Federal Drug Administration (FDA) requires drug product labels to include specific information. Unfortunately, several studies have found that drug product labeling fails to keep current with the scientific literature. We present a novel approach to addressing this issue. The primary goal of this novel approach is to better meet the information needs of persons who consult the drug product label for information on a drug’s efficacy, effectiveness, and safety. Using FDA product label regulations as a guide, the approach links drug claims present in drug information sources available on the Semantic Web with specific product label sections. Here we report on pilot work that establishes the baseline performance characteristics of a proof-of-concept system implementing the novel approach. Claims from three drug information sources were linked to the Clinical Studies, Drug Interactions, and Clinical Pharmacology sections of the labels for drug products that contain one of 29 psychotropic drugs. The resulting Linked Data set maps 409 efficacy/effectiveness study results, 784 drug-drug interactions, and 112 metabolic pathway assertions derived from three clinically-oriented drug information sources (ClinicalTrials.gov, the National Drug File – Reference Terminology, and the Drug Interaction Knowledge Base) to the sections of 1,102 product labels. Proof-of-concept web pages were created for all 1,102 drug product labels that demonstrate one possible approach to presenting information that dynamically enhances drug product labeling. We found that approximately one in five efficacy/effectiveness claims were relevant to the Clinical Studies section of a psychotropic drug product, with most relevant claims providing new information. We also identified several cases where all of the drug-drug interaction claims linked to the Drug Interactions section for a drug were potentially novel. The baseline performance characteristics of the proof-of-concept will enable further technical and user-centered research on robust methods for scaling the approach to the many thousands of product labels currently on the market. PMID:23351881

Label-free reflectance hyperspectral imaging for tumor margin assessment: a pilot study on surgical specimens of cancer patients

NASA Astrophysics Data System (ADS)

Fei, Baowei; Lu, Guolan; Wang, Xu; Zhang, Hongzheng; Little, James V.; Patel, Mihir R.; Griffith, Christopher C.; El-Diery, Mark W.; Chen, Amy Y.

2017-08-01

A label-free, hyperspectral imaging (HSI) approach has been proposed for tumor margin assessment. HSI data, i.e., hypercube (x,y,λ), consist of a series of high-resolution images of the same field of view that are acquired at different wavelengths. Every pixel on an HSI image has an optical spectrum. In this pilot clinical study, a pipeline of a machine-learning-based quantification method for HSI data was implemented and evaluated in patient specimens. Spectral features from HSI data were used for the classification of cancer and normal tissue. Surgical tissue specimens were collected from 16 human patients who underwent head and neck (H&N) cancer surgery. HSI, autofluorescence images, and fluorescence images with 2-deoxy-2-[(7-nitro-2,1,3-benzoxadiazol-4-yl)amino]-D-glucose (2-NBDG) and proflavine were acquired from each specimen. Digitized histologic slides were examined by an H&N pathologist. The HSI and classification method were able to distinguish between cancer and normal tissue from the oral cavity with an average accuracy of 90%±8%, sensitivity of 89%±9%, and specificity of 91%±6%. For tissue specimens from the thyroid, the method achieved an average accuracy of 94%±6%, sensitivity of 94%±6%, and specificity of 95%±6%. HSI outperformed autofluorescence imaging or fluorescence imaging with vital dye (2-NBDG or proflavine). This study demonstrated the feasibility of label-free, HSI for tumor margin assessment in surgical tissue specimens of H&N cancer patients. Further development of the HSI technology is warranted for its application in image-guided surgery.

An open-label naturalistic pilot study of acamprosate in youth with autistic disorder.

PubMed

Erickson, Craig A; Early, Maureen; Stigler, Kimberly A; Wink, Logan K; Mullett, Jennifer E; McDougle, Christopher J

2011-12-01

To date, placebo-controlled drug trials targeting the core social impairment of autistic disorder (autism) have had uniformly negative results. Given this, the search for new potentially novel agents targeting the core social impairment of autism continues. Acamprosate is U.S. Food and Drug Administration-approved drug to treat alcohol dependence. The drug likely impacts both gamma-aminobutyric acid and glutamate neurotransmission. This study describes our initial open-label experience with acamprosate targeting social impairment in youth with autism. In this naturalistic report, five of six youth (mean age, 9.5 years) were judged treatment responders to acamprosate (mean dose 1,110 mg/day) over 10 to 30 weeks (mean duration, 20 weeks) of treatment. Acamprosate was well tolerated with only mild gastrointestinal adverse effects noted in three (50%) subjects.

The effect of menu labeling with calories and exercise equivalents on food selection and consumption.

PubMed

Platkin, Charles; Yeh, Ming-Chin; Hirsch, Kimberly; Wiewel, Ellen Weiss; Lin, Chang-Yun; Tung, Ho-Jui; Castellanos, Victoria H

2014-01-01

Better techniques are needed to help consumers make lower calorie food choices. This pilot study examined the effect of menu labeling with caloric information and exercise equivalents (EE) on food selection. Participants, 62 females, ages 18-34, recruited for this study, ordered a fast food meal with menus that contained the names of the food (Lunch 1 (L1), control meal). One week later (Lunch 2 (L2), experiment meal), participants ordered a meal from one of three menus with the same items as the previous week: no calorie information, calorie information only, or calorie information and EE. There were no absolute differences between groups in calories ordered from L1 to L2. However, it is noteworthy that calorie only and calorie plus exercise equivalents ordered about 16% (206 kcal) and 14% (162 kcal) fewer calories from Lunch 1 to Lunch 2, respectively; whereas, the no information group ordered only 2% (25 kcal) fewer. Menu labeling alone may be insufficient to reduce calories; however, further research is needed in finding the most effective ways of presenting the menu labels for general public.

Proton pump inhibitors and vascular function: A prospective cross-over pilot study.

PubMed

Ghebremariam, Yohannes T; Cooke, John P; Khan, Fouzia; Thakker, Rahul N; Chang, Peter; Shah, Nigam H; Nead, Kevin T; Leeper, Nicholas J

2015-08-01

Proton pump inhibitors (PPIs) are commonly used drugs for the treatment of gastric reflux. Recent retrospective cohorts and large database studies have raised concern that the use of PPIs is associated with increased cardiovascular (CV) risk. However, there is no prospective clinical study evaluating whether the use of PPIs directly causes CV harm. We conducted a controlled, open-label, cross-over pilot study among 21 adults aged 18 and older who are healthy (n=11) or have established clinical cardiovascular disease (n=10). Study subjects were assigned to receive a PPI (Prevacid; 30 mg) or a placebo pill once daily for 4 weeks. After a 2-week washout period, participants were crossed over to receive the alternate treatment for the ensuing 4 weeks. Subjects underwent evaluation of vascular function (by the EndoPAT technique) and had plasma levels of asymmetric dimethylarginine (ADMA, an endogenous inhibitor of endothelial function previously implicated in PPI-mediated risk) measured prior to and after each treatment interval. We observed a marginal inverse correlation between the EndoPAT score and plasma levels of ADMA (r = -0.364). Subjects experienced a greater worsening in plasma ADMA levels while on PPI than on placebo, and this trend was more pronounced amongst those subjects with a history of vascular disease. However, these trends did not reach statistical significance, and PPI use was also not associated with an impairment in flow-mediated vasodilation during the course of this study. In conclusion, in this open-label, cross-over pilot study conducted among healthy subjects and coronary disease patients, PPI use did not significantly influence vascular endothelial function. Larger, long-term and blinded trials are needed to mechanistically explain the correlation between PPI use and adverse clinical outcomes, which has recently been reported in retrospective cohort studies. © The Author(s) 2015.

Consistency of the Relations of Cognitive Ability and Personality Traits to Pilot Training Performance

DTIC Science & Technology

2014-08-22

MAB-II scores. The univariate Case II correction ( Thorndike , 1949) was used for the NEO-PI-R scores due to a lack of sufficient data to apply the...pilot training, AFRL-RH-WP-TR-2013-0081. Wright-Patterson AFB, OH: Air Force Research Laboratory, Decision Making Division. Thorndike , R. L...NEO domain scores were corrected using the univariate Case 2 ( Thorndike , 1949) method. Correlations in the column labeled rfc were corrected for both

Alternative Perspectives on Risk: Individual Differences in Problem Structuring

NASA Technical Reports Server (NTRS)

Orasanu, Judith; Fischer, Ute; Connors, Mary M. (Technical Monitor)

1997-01-01

Team decision making involves contributions of multiple players toward a common goal. While much has been written about the importance of developing shared mental models in order for teams to work together effectively, little has been done to determine the value of alternative perspectives on problem solving and decision making. Early studies of expertise contrasted experts with novices and noted that the two groups differ in the way they structure problems and in their selection of information as salient. Little attention has been given to differences among experts who differ in their specializations. A series of experiments was conducted to determine: (1) what dimensions of flight-related problem situations pilots judge to be most important when making flight-relevant decisions; and (2) whether pilots in different crew positions differ in the way they interpret problems relating to flight decisions. A sorting task was used to identify underlying dimensions judged as salient to individual pilots. Captains, first officers, and flight engineers from two major carriers participated in the study. Twenty-two flight scenarios were developed based on ASRS reports. Pilots were required to make judgments about how they would respond in each case and to sort the scenarios on the basis of similarity of decision factors. They were also asked to provide a verbal label that described each of their sorted categories. A second study required a different group of pilots (also captains, first officers and flight engineers) to sort on predetermined bases.

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.

Actigraphy in Patients With Major Depressive Disorder Undergoing Repetitive Transcranial Magnetic Stimulation: An Open Label Pilot Study.

PubMed

Nishida, Masaki; Kikuchi, Senichiro; Nisijima, Koichi; Suda, Shiro

2017-03-01

The effects of repetitive transcranial magnetic stimulation (rTMS) on physical activity and sleep patterns in individuals with major depressive disorder (MDD) remain unclear. We examined the effects of rTMS treatment on the rest-activity cycle and sleep disturbances in MDD. In this open-label pilot study, 14 patients with medication-resistant MDD underwent 10 rTMS sessions over the bilateral dorsolateral prefrontal cortex. In addition to Hamilton Depression Rating Scale and Pittsburgh Sleep Quality Index scores, waist actigraphy was used to evaluate alterations in the rest-activity cycle over the course of rTMS treatments. Actigraphic data were evaluated at baseline and in the first (rTMS sessions 1-3), second (rTMS sessions 4-7), and third (rTMS sessions 8-10) sections. Although Hamilton Depression Rating Scale and Pittsburgh Sleep Quality Index scores were significantly improved by rTMS, sleep variables assessed by actigraphy did not show significant changes. However, post hoc tests indicated a significant increase in mean steps per day between the baseline and first section time points (P = 0.014; t13 = -2.316). Our data indicated that a daytime physical activity response to rTMS occurred in early sessions, whereas subjective symptom improvements were consistent across all sessions. Future double-blind placebo-controlled studies assessing the effects of rTMS on the rest-activity cycle and sleep disturbances in MDD are warranted.

Antiviral therapy in hepatitis B virus-infected children with immune-tolerant characteristics: A pilot open-label randomized study.

PubMed

Zhu, Shishu; Zhang, Hongfei; Dong, Yi; Wang, Limin; Xu, Zhiqiang; Liu, Weiwei; Gan, Yu; Tang, Hongmei; Chen, Dawei; Wang, Fuchuan; Zhao, Pan

2018-06-01

Chronic infection with hepatitis B virus (HBV) in children is a serious health problem worldwide. How to treat children with immune-tolerant chronic hepatitis B infection, commonly characterized by hepatitis B e antigen (HBeAg) positivity, high viral load, normal or mildly elevated alanine aminotransferase and no or minimal inflammation in liver histology, remains unresolved. This trial aims to study the benefits of antiviral therapy in children with these characteristics. This is a pilot open-label randomized controlled study. From May 2014 to April 2015, 69 treatment-naive chronically HBV-infected children, aged 1 to 16 years, who had immune-tolerant characteristics were recruited to this trial and randomly assigned, in a 2:1 ratio, to treatment group and control group. Patients in the treatment group received either interferon-α (IFN) monotherapy or consecutively received IFN monotherapy, combination therapy of IFN and lamivudine (LAM), and LAM therapy alone. All patients were observed until week 96. At baseline, epidemiological, biochemical, serological, virological and histological indices were consistent across the treatment and control groups. Of the 46 patients in the treatment group, 73.91% had undetectable serum HBV DNA, 32.61% achieved HBeAg seroconversion and 21.74% lost hepatitis B surface antigen (HBsAg) at the endpoint. No LAM resistance emerged at week 96. In the control group, only one (4.35%) patient underwent spontaneous HBeAg seroconversion and had undetectable serum HBV DNA during observation, and moreover, none developed HBsAg clearance. For all patients, no serious adverse events were observed. Antiviral treatment with a sequential combination of IFN and LAM resulted in a significant improvement in the rates of undetectable serum HBV DNA, HBeAg seroconversion and HBsAg loss in children with chronic HBV infection and immune-tolerant characteristics. There is a lack of data regarding treatment of immune-tolerant chronic hepatitis B (CHB). It remains unresolved how children with immune-tolerant CHB should be treated. This paper reports the outcomes from a pilot open-label randomized controlled trial on antiviral therapy in children with immune-tolerant characteristics. It shows that a sequential combination of interferon-α and lamivudine was beneficial. Copyright © 2018 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

An open-label pilot trial of alpha-lipoic acid for weight loss in patients with schizophrenia without diabetes.

PubMed

Ratliff, Joseph C; Palmese, Laura B; Reutenauer, Erin L; Tek, Cenk

2015-01-01

A possible mechanism of antipsychotic-induced weight gain is activation of hypothalamic monophosphate-dependent kinase (AMPK) mediated by histamine 1 receptors. Alpha-lipoic acid (ALA), a potent antioxidant, counteracts this effect and may be helpful in reducing weight for patients taking antipsychotics. The objective of this open-label study was to assess the efficacy of ALA (1,200 mg) on twelve non-diabetic schizophrenia patients over ten weeks. Participants lost significant weight during the intervention (-2.2 kg±2.5 kg). ALA was well tolerated and was particularly effective for individuals taking strongly antihistaminic antipsychotics (-2.9 kg±2.6 kg vs. -0.5 kg±1.0 kg). NCT01355952.

Douching with Water Works device for perceived vaginal odor with or without complaints of discharge in women with no infectious cause of vaginitis: a pilot study.

PubMed

Chatwani, Ashwin J; Hassan, Sarmina; Rahimi, Salma; Jeronis, Stacey; Dandolu, Vani

2006-01-01

To determine if douching with Water Works device for 1 month can (1) lower or eliminate perceived vaginal odor by subject; (2) have any effects on vaginal ecosystem. Ten women with perceived vaginal odor with or without discharge, douched every day for 4 weeks in an open-label, nonrandomized pilot study. Primary outcome measures included perceived vaginal odor by subject, lactobacilli score from Nugent slide, and acceptance of the Water Works douching system. Secondary outcome included the safety of using this douching device. At week 4, there was improvement in vaginal odor (P=.0006) and there was no significant change in lactobacilli score. Douching with Water Works device is associated with reduction or elimination of vaginal odor without adversely affecting the vaginal ecosystem.

An Open-Label Naturalistic Pilot Study of Acamprosate in Youth with Autistic Disorder

PubMed Central

Early, Maureen; Stigler, Kimberly A.; Wink, Logan K.; Mullett, Jennifer E.; McDougle, Christopher J.

2011-01-01

Abstract To date, placebo-controlled drug trials targeting the core social impairment of autistic disorder (autism) have had uniformly negative results. Given this, the search for new potentially novel agents targeting the core social impairment of autism continues. Acamprosate is U.S. Food and Drug Administration–approved drug to treat alcohol dependence. The drug likely impacts both gamma-aminobutyric acid and glutamate neurotransmission. This study describes our initial open-label experience with acamprosate targeting social impairment in youth with autism. In this naturalistic report, five of six youth (mean age, 9.5 years) were judged treatment responders to acamprosate (mean dose 1,110 mg/day) over 10 to 30 weeks (mean duration, 20 weeks) of treatment. Acamprosate was well tolerated with only mild gastrointestinal adverse effects noted in three (50%) subjects. PMID:22136091

Preliminary, open-label, pilot study of add-on oral Δ9-tetrahydrocannabinol in chronic post-traumatic stress disorder.

PubMed

Roitman, Pablo; Mechoulam, Raphael; Cooper-Kazaz, Rena; Shalev, Arieh

2014-08-01

Many patients with post-traumatic stress disorder (PTSD) achieve but partial remission with current treatments. Patients with unremitted PTSD show high rates of substance abuse. Marijuana is often used as compassion add-on therapy for treatment-resistant PTSD. This open-label study evaluates the tolerance and safety of orally absorbable Δ(9)-tetrahydrocannabinol (THC) for chronic PTSD. Ten outpatients with chronic PTSD, on stable medication, received 5 mg of Δ(9)-THC twice a day as add-on treatment. There were mild adverse effects in three patients, none of which led to treatment discontinuation. The intervention caused a statistically significant improvement in global symptom severity, sleep quality, frequency of nightmares, and PTSD hyperarousal symptoms. Orally absorbable Δ(9)-THC was safe and well tolerated by patients with chronic PTSD.

Development and evaluation of pictograms on medication labels for patients with limited literacy skills in a culturally diverse multiethnic population.

PubMed

Kheir, Nadir; Awaisu, Ahmed; Radoui, Amina; El Badawi, Aya; Jean, Linda; Dowse, Ros

2014-01-01

Much of the migrant workforce in Qatar is of low literacy level and does not understand Arabic or English, presenting a significant challenge to health care professionals. Medicine labels are typically in Arabic and English and are therefore poorly understood by these migrant workers. To develop pictograms illustrating selected medicine label instructions and to evaluate comprehension of the pictograms or conventional text supported with verbal instructions in foreign workers with low literacy skills. A range of common labeling instructions were identified and pictograms depicting these were developed using visual concepts and ideas from the literature. The process involved a consultative approach with input from the researchers, a local graphic artist, and members of the target population. The final set was evaluated for comprehension in participants who were randomized to one of three study groups: text plus verbal instructions, pictogram-only label, and pictogram with verbal instructions. One-way ANOVA and Chi-square tests were used to assess differences between group variables. Statistical significance was set at P ≤ 0.05. Of 23 label instructions screened, 11 were selected for the study. A total of 123 participants took part in this study. Pictogram plus verbal instructions group achieved better results in interpreting the majority of the label instructions (P ≤ 0.05). The best interpreted pictograms with verbal instructions included: "Take two tablets three times a day," "Take one tablet in the morning and one tablet at night," and "Instill one drop in the eye." The worst interpreted pictograms with verbal instructions were: "Do not take with dairy products" and "Do not use by mouth." Some pictograms were difficult to interpret even when accompanied with verbal instructions, suggesting the need to thoroughly pilot them among users prior to implementation. Medication labels consisting of simple pictorials supported by verbal instructions were better comprehended by individuals with low literacy skills than labels with written plus verbal instructions in a language that the individual did not understand. Further, pictogram-only labels were the least comprehended types of medicine labels among the participants. Copyright © 2014 Elsevier Inc. All rights reserved.

Neurofeedback as a treatment for major depressive disorder--a pilot study.

PubMed

Peeters, Frenk; Oehlen, Mare; Ronner, Jacco; van Os, Jim; Lousberg, Richel

2014-01-01

There is growing interest in neurofeedback as a treatment for major depressive disorder. Reduction of asymmetry of alpha-activity between left and right prefrontal areas with neurofeedback has been postulated as effective in earlier studies. Unfortunately, methodological shortcomings limit conclusions that can be drawn from these studies. In a pilot-study, we investigated the effectiveness of reduction of asymmetry of alpha-activity with neurofeedback in depressed participants with the use of a stringent methodological approach. Nine participants meeting DSM-IV criteria for major depressive disorder were treated with a maximum of 30 neurofeedback-sessions, aimed at reducing asymmetry of alpha-activity, over a 10-week period. No changes in the use of antidepressants were allowed 6 weeks before and during the intervention. Changes in depressive symptomatology were assessed with the Quick Inventory of Depressive Symptoms, self-report version. We observed response in 1 and remission in 4 out of a total of 9 participants. The effectiveness appeared largest in female participants. The mean asymmetry of alpha-activity decreased significantly over sessions in a quadratic fashion. This decrease was associated with clinical response. This pilot study suggests that neurofeedback aimed at a reduction of frontal asymmetry of alpha-activity may be effective as a treatment for depression. However, this was an open label pilot study. Non-specific effects of the procedure and/or a beneficial natural course may have confounded the results. Randomized controlled trials will have to establish the efficacy of neurofeedback for depression. Nederlands Trial Register NTR1629.

[Emotion Recognition in Patients with Peripheral Facial Paralysis - A Pilot Study].

PubMed

Konnerth, V; Mohr, G; von Piekartz, H

2016-02-01

The perception of emotions is an important component in enabling human beings to social interaction in everyday life. Thus, the ability to recognize the emotions of the other one's mime is a key prerequisite for this. The following study aimed at evaluating the ability of subjects with 'peripheral facial paresis' to perceive emotions in healthy individuals. A pilot study was conducted in which 13 people with 'peripheral facial paresis' participated. This assessment included the 'Facially Expressed Emotion Labeling-Test' (FEEL-Test), the 'Facial-Laterality-Recognition Test' (FLR-Test) and the 'Toronto-Alexithymie-Scale 26' (TAS 26). The results were compared with data of healthy people from other studies. In contrast to healthy patients, the subjects with 'facial paresis' show more difficulties in recognizing basic emotions; however the results are not significant. The participants show a significant lower level of speed (right/left: p<0.001) concerning the perception of facial laterality compared to healthy people. With regard to the alexithymia, the tested group reveals significantly higher results (p<0.001) compared to the unimpaired people. The present pilot study does not prove any impact on this specific patient group's ability to recognize emotions and facial laterality. For future studies the research question should be verified in a larger sample size. © Georg Thieme Verlag KG Stuttgart · New York.

Adaptable Constrained Genetic Programming: Extensions and Applications

NASA Technical Reports Server (NTRS)

Janikow, Cezary Z.

2005-01-01

An evolutionary algorithm applies evolution-based principles to problem solving. To solve a problem, the user defines the space of potential solutions, the representation space. Sample solutions are encoded in a chromosome-like structure. The algorithm maintains a population of such samples, which undergo simulated evolution by means of mutation, crossover, and survival of the fittest principles. Genetic Programming (GP) uses tree-like chromosomes, providing very rich representation suitable for many problems of interest. GP has been successfully applied to a number of practical problems such as learning Boolean functions and designing hardware circuits. To apply GP to a problem, the user needs to define the actual representation space, by defining the atomic functions and terminals labeling the actual trees. The sufficiency principle requires that the label set be sufficient to build the desired solution trees. The closure principle allows the labels to mix in any arity-consistent manner. To satisfy both principles, the user is often forced to provide a large label set, with ad hoc interpretations or penalties to deal with undesired local contexts. This unfortunately enlarges the actual representation space, and thus usually slows down the search. In the past few years, three different methodologies have been proposed to allow the user to alleviate the closure principle by providing means to define, and to process, constraints on mixing the labels in the trees. Last summer we proposed a new methodology to further alleviate the problem by discovering local heuristics for building quality solution trees. A pilot system was implemented last summer and tested throughout the year. This summer we have implemented a new revision, and produced a User's Manual so that the pilot system can be made available to other practitioners and researchers. We have also designed, and partly implemented, a larger system capable of dealing with much more powerful heuristics.

Douching With Water Works Device for Perceived Vaginal Odor With or Without Complaints of Discharge in Women With No Infectious Cause of Vaginitis: A Pilot Study

PubMed Central

Chatwani, Ashwin J.; Hassan, Sarmina; Rahimi, Salma; Jeronis, Stacey; Dandolu, Vani

2006-01-01

Objective. To determine if douching with Water Works device for 1 month can (1) lower or eliminate perceived vaginal odor by subject; (2) have any effects on vaginal ecosystem. Methods. Ten women with perceived vaginal odor with or without discharge, douched every day for 4 weeks in an open-label, nonrandomized pilot study. Primary outcome measures included perceived vaginal odor by subject, lactobacilli score from Nugent slide, and acceptance of the Water Works douching system. Secondary outcome included the safety of using this douching device. Results. At week 4, there was improvement in vaginal odor (P = .0006) and there was no significant change in lactobacilli score. Conclusion. Douching with Water Works device is associated with reduction or elimination of vaginal odor without adversely affecting the vaginal ecosystem. PMID:17485816

Development and Preliminary Feasibility Study of a Brief Behavioral Activation Mobile Application (Behavioral Apptivation) to Be Used in Conjunction With Ongoing Therapy.

PubMed

Dahne, Jennifer; Kustanowitz, Jacob; Lejuez, C W

2018-02-01

Depressive symptoms are the most frequently treated psychiatric condition in the United States. Brief behavioral activation treatment for depression (BATD) is a popular, evidence-based psychotherapy with strong research support for the treatment of depression. In this paper, we describe the development and initial pilot feasibility testing of a BATD mobile application (Behavioral Apptivation) to be used by patients and therapists in conjunction with BATD therapy. We present information regarding the app development process as well as results from a small open-label feasibility trial of the app utilized in conjunction with individual BATD. We include a case series from the open-label trial highlighting how Behavioral Apptivation can be utilized in clinical practice.

Prospective, open-label, uncontrolled pilot study to study safety and efficacy of sildenafil in systemic sclerosis-related pulmonary artery hypertension and cutaneous vascular complications.

PubMed

Kumar, Uma; Sankalp, Gokhale; Gokhle, Sankalp S; Sreenivas, V; Kaur, Satbir; Misra, Durgaprasanna

2013-04-01

Pulmonary artery hypertension (PAH) remains the leading cause of morbidity and mortality in systemic sclerosis, while Raynaud's phenomenon and digital ulcers significantly add to the morbidity in systemic sclerosis (SSc). This study was undertaken to evaluate the role of sildenafil in PAH, Raynaud's phenomenon, and digital ulcers in systemic sclerosis patients. A prospective, open-label, uncontrolled pilot study was done at a tertiary care centre in India to study the safety and efficacy of oral sildenafil in PAH, Raynaud's phenomenon, digital infarcts, and ulcers in SSc. Seventeen patients fulfilling ACR classification criteria for scleroderma and having PAH were recruited. Six-minute walk test, WHO class of dyspnoea, severity of Raynaud's phenomenon, and 2D ECHO were performed in all the study subjects at baseline and at 3 months post-treatment. All patients were treated with oral sildenafil 25 mg three times a day for a period of 3 months. The pre- and post-treatment values of mean pulmonary artery pressure (PAP), 6-min walk test, WHO class of dyspnoea, and severity of Raynaud's phenomenon were compared to look for any significant change. Sixteen patients who completed 3-month follow-up had shown statistically significant improvement in 6-min walk test, WHO class of dyspnoea, severity of Raynaud's phenomenon, and mPAP. Also, there was no occurrence of new digital infarcts or ulcers, and existing ulcers showed signs of healing. Sildenafil is highly efficacious cheaper and safe alternative to other available therapies for SSc-associated PAH, Raynaud's phenomenon, and digital infarcts/ulcers.

Rehabilitation of balance disturbances due to chemotherapy-induced peripheral neuropathy: a pilot study.

PubMed

Cammisuli, Sharon; Cavazzi, Enrico; Baldissarro, Eleonora; Leandri, Massimo

2016-08-01

Cancer patients with chemotherapy-induced peripheral neuropathy (CIPN) have sensory and motor deficits leading to inappropriate proprioceptive feedback, impaired postural control, and fall risk. Balance training with computerized force platforms has been successfully used in rehabilitation of balance disturbances, but programs specifically developed for CIPN patients are lacking. This pilot study evaluated a rehabilitation protocol exclusively based on visual computer-feedback balance training (VCFBT) to improve balance in patients with CIPN. Open-label, non-randomized pilot study, 4-week intervention with pre- vs. post-treatment evaluation. Outpatients of the Rehabilitation Institute of the Salvatore Maugeri Foundation, in Genoa, Italy. Seven out-patients with clinical-instrumental diagnosis of CIPN. At admission, patients were administered the Berg Balance Scale (BBS) and underwent static-dynamic posturography using a computerized force platform to objectively quantify their balance impairment. Their performance was compared to values of a normal age-matched population. Patients then underwent 4 weeks of VCFBT (three 60-minute sessions/week). At discharge, BBS and posturography were repeated and the results compared with those at admission. A significant pre- vs. post-treatment improvement was found in balance as measured by static-dynamic posturography (P=0.004) and BBS (P<0.002). Despite caution needed for the low sample size, this pilot study has shown preliminary evidence that intensive rehabilitation, based on VCFBT can produce a significant improvement in balance outcomes. To our knowledge, this is the first report in CIPN patients of a rehabilitation program based exclusively on VCFBT.

Tipepidine in children with attention deficit/hyperactivity disorder: a 4-week, open-label, preliminary study

PubMed Central

Sasaki, Tsuyoshi; Hashimoto, Kenji; Tachibana, Masumi; Kurata, Tsutomu; Okawada, Keiko; Ishikawa, Maki; Kimura, Hiroshi; Komatsu, Hideki; Ishikawa, Masatomo; Hasegawa, Tadashi; Shiina, Akihiro; Hashimoto, Tasuku; Kanahara, Nobuhisa; Shiraishi, Tetsuya; Iyo, Masaomi

2014-01-01

Background Tipepidine (3-[di-2-thienylmethylene]-1-methylpiperidine) has been used solely as a nonnarcotic antitussive in Japan since 1959. The safety of tipepidine in children and adults has already been established. It is reported that tipepidine inhibits G-protein-coupled inwardly rectifying potassium (GIRK)-channel currents. The inhibition of GIRK channels by tipepidine is expected to modulate the level of monoamines in the brain. We put forward the hypothesis that tipepidine can improve attention deficit/hyperactivity disorder (ADHD) symptoms by modulating monoaminergic neurotransmission through the inhibition of GIRK channels. The purpose of this open-label trial was to confirm whether treatment with tipepidine can improve symptoms in pediatric patients with ADHD. Subjects and methods This was a 4-week, open-label, proof-of-efficacy pilot study for pediatric subjects with ADHD. Ten pediatric ADHD subjects (70% male; mean age, 9.9 years; combined [inattentive and hyperactive/impulsive] subtype, n=7; inattentive subtype, n=3; hyperimpulsive subtype, n=0) received tipepidine hibenzate taken orally at 30 mg/day for 4 weeks. All subjects were assessed using the ADHD Rating Scale IV (ADHD-RS), Japanese version, and the Das–Naglieri Cognitive Assessment System (DN-CAS), Japanese version. Results A comparison of baseline scores and 4-week end-point scores showed that all the ADHD-RS scores (total scores, hyperimpulsive subscores, and inattentive subscores) improved significantly (P<0.001). Furthermore, a comparison of baseline DN-CAS total scores and 4-week end-point scores showed a mild trend of improvement (P=0.093). Tipepidine was well tolerated, with no patients discontinuing medication because of side effects. Conclusion Our pilot study suggests that tipepidine therapy may prove to be an effective alternative treatment for pediatric patients with ADHD. Nonetheless, more detailed randomized, double-blind trials are needed to confirm tipepidine’s efficacy. PMID:24493927

WASTE MINIMIZATION ASSESSMENT FOR A MANUFACTURER OF PRINTED LABELS

EPA Science Inventory

The U.S. Environmental Protection Agency (EPA) has funded a pilot project to assist small- and medium-size manufacturers who want to minimize their generation of hazardous waste but lack the expertise to do so. Waste Minimization Assessment Centers (WMACs) were established at sel...

Pediatric microdose study of [(14)C]paracetamol to study drug metabolism using accelerated mass spectrometry: proof of concept.

PubMed

Mooij, Miriam G; van Duijn, Esther; Knibbe, Catherijne A J; Windhorst, Albert D; Hendrikse, N Harry; Vaes, Wouter H J; Spaans, Edwin; Fabriek, Babs O; Sandman, Hugo; Grossouw, Dimitri; Hanff, Lidwien M; Janssen, Paul J J M; Koch, Birgit C P; Tibboel, Dick; de Wildt, Saskia N

2014-11-01

Pediatric drug development is hampered by practical, ethical, and scientific challenges. Microdosing is a promising new method to obtain pharmacokinetic data in children with minimal burden and minimal risk. The use of a labeled oral microdose offers the added benefit to study intestinal and hepatic drug disposition in children already receiving an intravenous therapeutic drug dose for clinical reasons. The objective of this study was to present pilot data of an oral [(14)C]paracetamol [acetaminophen (AAP)] microdosing study as proof of concept to study developmental pharmacokinetics in children. In an open-label microdose pharmacokinetic pilot study, infants (0-6 years of age) received a single oral [(14)C]AAP microdose (3.3 ng/kg, 60 Bq/kg) in addition to intravenous therapeutic doses of AAP (15 mg/kg intravenous every 6 h). Blood samples were taken from an indwelling catheter. AAP blood concentrations were measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS) and [(14)C]AAP and metabolites ([(14)C]AAP-Glu and [(14)C]AAP-4Sul) were measured by accelerator mass spectrometry. Ten infants (aged 0.1-83.1 months) were included; one was excluded as he vomited shortly after administration. In nine patients, [(14)C]AAP and metabolites in blood samples were detectable at expected concentrations: median (range) maximum concentration (C max) [(14)C]AAP 1.68 (0.75-4.76) ng/L, [(14)C]AAP-Glu 0.88 (0.34-1.55) ng/L, and [(14)C]AAP-4Sul 0.81 (0.29-2.10) ng/L. Dose-normalized oral [(14)C]AAP C max approached median intravenous average concentrations (C av): 8.41 mg/L (3.75-23.78 mg/L) and 8.87 mg/L (3.45-12.9 mg/L), respectively. We demonstrate the feasibility of using a [(14)C]labeled microdose to study AAP pharmacokinetics, including metabolite disposition, in young children.

Consumer perception of risk associated with eating genetically engineered soybeans is less in the presence of a perceived consumer benefit.

PubMed

Brown, J Lynne; Ping, Yanchao

2003-02-01

To determine whether perceived benefit alters personal risk perception associated with eating genetically engineered soybeans, consumer desire for labeling, preferred phrase on a label symbol, and desired information in an educational brochure. Comparison of responses of two consumer groups who completed one of two survey versions. One hundred fifty supermarket shoppers, age 21 years and older, for each survey or n=300 total. Focus groups and a pilot test were used to develop the final survey in which consumers read a description of a genetically engineered soybean with either no obvious consumer benefit or an obvious consumer benefit and then completed a set of attitude questions and evaluated a voluntary label design and educational brochure content. Main outcome measures were mean opinion scores of personal risk and desire for labeling and ranking of desired label phrase and brochure topics. Chi;(2) and t Tests were used. Consumers reading about the soybean with obvious consumer benefit were significantly more comfortable eating these than those reading about the soybean with no obvious consumer benefit (2.9+/-1.1 vs 3.4+/-1.0, respectively; P

Improving accuracy of medication identification in an older population using a medication bottle color symbol label system

PubMed Central

2011-01-01

Background The purpose of this pilot study was to evaluate and refine an adjuvant system of color-specific symbols that are added to medication bottles and to assess whether this system would increase the ability of patients 65 years of age or older in matching their medication to the indication for which it was prescribed. Methods This study was conducted in two phases, consisting of three focus groups of patients from a family medicine clinic (n = 25) and a pre-post medication identification test in a second group of patient participants (n = 100). Results of focus group discussions were used to refine the medication label symbols according to themes and messages identified through qualitative triangulation mechanisms and data analysis techniques. A pre-post medication identification test was conducted in the second phase of the study to assess differences between standard labeling alone and the addition of the refined color-specific symbols. The pre-post test examined the impact of the added labels on participants' ability to accurately match their medication to the indication for which it was prescribed when placed in front of participants and then at a distance of two feet. Results Participants appreciated the addition of a visual aid on existing medication labels because it would not be necessary to learn a completely new system of labeling, and generally found the colors and symbols used in the proposed labeling system easy to understand and relevant. Concerns were raised about space constraints on medication bottles, having too much information on the bottle, and having to remember what the colors meant. Symbols and colors were modified if they were found unclear or inappropriate by focus group participants. Pre-post medication identification test results in a second set of participants demonstrated that the addition of the symbol label significantly improved the ability of participants to match their medication to the appropriate medical indication at a distance of two feet (p < 0.001) and approached significant improvement when placed directly in front of participants (p = 0.07). Conclusions The proposed medication symbol label system provides a promising adjunct to national efforts in addressing the issue of medication misuse in the home through the improvement of medication labeling. Further research is necessary to determine the effectiveness of the labeling system in real-world settings. PMID:22206490

Improving accuracy of medication identification in an older population using a medication bottle color symbol label system.

PubMed

Cardarelli, Roberto; Mann, Christopher; Fulda, Kimberly G; Balyakina, Elizabeth; Espinoza, Anna; Lurie, Sue

2011-12-29

The purpose of this pilot study was to evaluate and refine an adjuvant system of color-specific symbols that are added to medication bottles and to assess whether this system would increase the ability of patients 65 years of age or older in matching their medication to the indication for which it was prescribed. This study was conducted in two phases, consisting of three focus groups of patients from a family medicine clinic (n = 25) and a pre-post medication identification test in a second group of patient participants (n = 100). Results of focus group discussions were used to refine the medication label symbols according to themes and messages identified through qualitative triangulation mechanisms and data analysis techniques. A pre-post medication identification test was conducted in the second phase of the study to assess differences between standard labeling alone and the addition of the refined color-specific symbols. The pre-post test examined the impact of the added labels on participants' ability to accurately match their medication to the indication for which it was prescribed when placed in front of participants and then at a distance of two feet. Participants appreciated the addition of a visual aid on existing medication labels because it would not be necessary to learn a completely new system of labeling, and generally found the colors and symbols used in the proposed labeling system easy to understand and relevant. Concerns were raised about space constraints on medication bottles, having too much information on the bottle, and having to remember what the colors meant. Symbols and colors were modified if they were found unclear or inappropriate by focus group participants. Pre-post medication identification test results in a second set of participants demonstrated that the addition of the symbol label significantly improved the ability of participants to match their medication to the appropriate medical indication at a distance of two feet (p < 0.001) and approached significant improvement when placed directly in front of participants (p = 0.07). The proposed medication symbol label system provides a promising adjunct to national efforts in addressing the issue of medication misuse in the home through the improvement of medication labeling. Further research is necessary to determine the effectiveness of the labeling system in real-world settings.

A Review of Pharmacologic Treatment for Compulsive Buying Disorder.

PubMed

Soares, Célia; Fernandes, Natália; Morgado, Pedro

2016-04-01

At present, no treatment recommendations can be made for compulsive buying disorder. Recent studies have found evidence for the efficacy of psychotherapeutic options, but less is known regarding the best pharmacologic treatment. The purpose of this review is to present and analyze the available published evidence on the pharmacological treatment of compulsive buying disorder. To achieve this, we conducted a review of studies focusing on the pharmacological treatment of compulsive buying by searching the PubMed/MEDLINE database. Selection criteria were applied, and 21 studies were identified. Pharmacological classes reported included antidepressants, mood stabilizers, opioid antagonists, second-generation antipsychotics, and N-methyl-D-aspartate receptor antagonists. We found only placebo-controlled trials for fluvoxamine; none showed effectiveness against placebo. Three open-label trials reported clinical improvement with citalopram; one was followed by a double-blind discontinuation. Escitalopram was effective in an open-label trial but did not show efficacy in the double-blind phase. Memantine was identified as effective in a pilot open-label study. Fluoxetine, bupropion, nortriptyline, clomipramine, topiramate and naltrexone were only reported to be effective in clinical cases. According to the available literature, there is no evidence to propose a specific pharmacologic agent for compulsive buying disorder. Future research is required for a better understanding of both pathogenesis and treatment of this disorder.

Levetiracetam versus lorazepam in status epilepticus: a randomized, open labeled pilot study.

PubMed

Misra, U K; Kalita, J; Maurya, P K

2012-04-01

For the management of status epilepticus (SE), lorazepam (LOR) is recommended as the first and phenytoin or fosphenytoin as the second choice. Both these drugs have significant toxicity. Intravenous levetiracetam (LEV) has become available, but its efficacy and safety has not been reported in comparison to LOR. We report a randomized, open labeled pilot study comparing the efficacy and safety of LEV and LOR in SE. Consecutive patients with convulsive or subtle convulsive SE were randomized to LEV 20 mg/kg IV over 15 min or LOR 0.1 mg/kg over 2-4 min. Failure to control SE within 10 min of administration of one study drug was treated by the other study drug. The primary endpoint was clinical seizure cessation and secondary endpoints were 24 h freedom from seizure, hospital mortality, and adverse events. Our results are based on 79 patients. Both LEV and LOR were equally effective. In the first instance, the SE was controlled by LEV in 76.3% (29/38) and by LOR in 75.6% (31/41) of patients. In those resistant to the above regimen, LEV controlled SE in 70.0% (7/10) and LOR in 88.9% (8/9) patients. The 24-h freedom from seizure was also comparable: by LEV in 79.3% (23/29) and LOR in 67.7% (21/31). LOR was associated with significantly higher need of artificial ventilation and insignificantly higher frequency of hypotension. For the treatment of SE, LEV is an alternative to LOR and may be preferred in patients with respiratory compromise and hypotension.

Levocetirizine in persistent allergic rhinitis: continuous or on-demand use? A pilot study.

PubMed

Canonica, Giorgio Walter; Fumagalli, Federica; Guerra, Laura; Baiardini, Ilaria; Compalati, Enrico; Rogkakou, Anthi; Massacane, Pierangela; Gamalero, Cinzia; Riccio, Anna Maria; Scordamaglia, Antonio; Passalacqua, Giovanni

2008-10-01

Allergic rhinitis is a high-prevalence disease that affects quality of life (QOL), sleep quality and productivity of patients. According to the ARIA initiative, it is classified as intermittent and persistent, the latter being the most troublesome. The aim of this randomized, open-label, 6-month, pilot study was to determine whether levocetirizine 5 mg administered continuously once daily in the morning was better than levocetirizine 5 mg on-demand in symptomatic subjects with persistent allergic rhinitis. Total and individual symptom scores were recorded in a diary card throughout the study. QOL, quality of sleep, nasal cytology, rate of drug intake, and safety were also assessed at pre-defined time-points. In all, adult patients (31 in each group) were enrolled, of whom 22 dropped out. Both treatment regimens considerably decreased the total and individual symptoms scores from baseline and achieved similar levels up to week 14. Continuous treatment was generally better than on-demand from week 15 onwards, reaching statistical significance from weeks 17 to 21 (from week 19 to 21 for nasal pruritus). Both regimens substantially improved QOL and sleep quality. Both treatments were well tolerated, although the on-demand group reported more adverse events. The present open label study in 62 patients indicates that levocetirizine 5 mg reliably controls persistent rhinitis over a period of 6 months, and shows a trend to be more effective in controlling the symptoms of rhinitis, improving QOL and decreasing nasal inflammation, when administered as long-term continuous therapy rather than as on-demand therapy.

Rationale, design and pilot feasibility results of a smartphone-assisted, mindfulness-based intervention for smokers with mood disorders: Project mSMART MIND.

PubMed

Minami, Haruka; Brinkman, Hannah R; Nahvi, Shadi; Arnsten, Julia H; Rivera-Mindt, Monica; Wetter, David W; Bloom, Erika Litvin; Price, Lawrence H; Vieira, Carlos; Donnelly, Remington; McClain, Lauren M; Kennedy, Katherine A; D'Aquila, Erica; Fine, Micki; McCarthy, Danielle E; Graham Thomas, J; Hecht, Jacki; Brown, Richard A

2018-03-01

Although individuals with psychiatric disorders are disproportionately affected by cigarette smoking, few outpatient mental health treatment facilities offer smoking cessation services. In this paper, we describe the development of a smartphone-assisted mindfulness smoking cessation intervention with contingency management (SMI-CM), as well as the design and methods of an ongoing pilot randomized controlled trial (RCT) targeting smokers receiving outpatient psychiatric treatment. We also report the results of an open-label pilot feasibility study. In phase 1, we developed and pilot-tested SMI-CM, which includes a smartphone intervention app that prompts participants to practice mindfulness, complete ecological momentary assessment (EMA) reports 5 times per day, and submit carbon monoxide (CO) videos twice per day. Participants earned incentives if submitted videos showed CO≤6ppm. In phase 2, smokers receiving outpatient treatment for mood disorders are randomized to receive SMI-CM or enhanced standard treatment plus non-contingent CM (EST). The results from the pilot feasibility study (N=8) showed that participants practiced mindfulness an average of 3.4times/day (≥3min), completed 72.3% of prompted EMA reports, and submitted 68.0% of requested CO videos. Participants reported that the program was helpful overall (M=4.85/5) and that daily mindfulness practice was helpful for both managing mood and quitting smoking (Ms=4.50/5). The results from the feasibility study indicated high levels of acceptability and satisfaction with SMI-CM. The ongoing RCT will allow evaluation of the efficacy and mechanisms of action underlying SMI-CM for improving cessation rates among smokers with mood disorders. Copyright © 2017 Elsevier Inc. All rights reserved.

Migraine with prolonged aura: phenotype and treatment.

PubMed

Viana, Michele; Afridi, Shazia

2018-01-01

We review the published literature on migraine with prolonged aura (PA), specifically with regards to the phenotype and treatment options. PA is not uncommon. A recent study found that about 17% of migraine auras are prolonged and that 26% of patients with migraine with aura have experienced at least one PA. The characteristics of PA are similar to most typical auras with the exception of a higher number of aura symptoms (in particular sensory and/or dysphasic). There are no well-established treatments at present which target the aura component of migraine. Other than case reports, there have been open-label studies of lamotrigine and greater occipital nerve blocks. The only randomised, blinded, controlled trial to date has been of nasal ketamine showing some reduction in aura severity but not duration. A small open-labelled pilot study of amiloride was also promising. Larger randomised, controlled trials are needed to establish whether any of the existing or novel compounds mentioned are significantly effective and safe.

Pilot study of atomoxetine in patients with Parkinson's disease and dopa-unresponsive Freezing of Gait.

PubMed

Revuelta, Gonzalo J; Embry, Aaron; Elm, Jordan J; Gregory, Chris; Delambo, Amy; Kautz, Steve; Hinson, Vanessa K

2015-01-01

Freezing of gait (FoG) is a common and debilitating condition in Parkinson's disease (PD) associated with executive dysfunction. A subtype of FoG does not respond to dopaminergic therapy and may be related to noradrenergic deficiency. This pilot study explores the effects of atomoxetine on gait in PD patients with dopa-unresponsive FoG using a novel paradigm for objective gait assessment. Ten patients with PD and dopa-unresponsive FoG were enrolled in this eight-week open label pilot study. Assessments included an exploratory gait analysis protocol that quantified spatiotemporal parameters during straight-away walking and turning, while performing a dual task. Clinical, and subjective assessments of gait, quality of life, and safety were also administered. The primary outcome was a validated subjective assessment for FoG (FOG-Q). Atomoxetine was well tolerated, however, no significant change was observed in the primary outcome. The gait analysis protocol correlated well with clinical scales, but not with subjective assessments. DBS patients were more likely to increase gait velocity (p = 0.033), and improved in other clinical assessments. Objective gait analysis protocols assessing gait while dual tasking are feasible and useful for this patient population, and may be superior correlates of FoG severity than subjective measures. These findings can inform future trials in this population.

A pilot study of gene expression analysis in workers with hand-arm vibration syndrome.

PubMed

Maeda, Setsuo; Yu, Xiaozhong; Wang, Rui-Sheng; Sakakibara, Hisataka

2008-04-01

The purpose of this pilot study was to examine differences in gene expressions by cDNA microarray analysis of hand-arm vibration syndrome (HAVS) patients. Vein blood samples were collected and total RNA was extracted. All blood samples were obtained in the morning in one visit after a standard light breakfast. We performed microarray analysis with the labeled cDNA prepared by reverse transcription from RNA samples, using the Human CHIP version 1 (DNA Chip Research Inc, Yokohama, Japan). There are 2,976 genes on the chip, and these genes were selected from a cDNA library prepared with human peripheral white blood cells (WBC). Different gene levels between the HAVS patients and controls, and between groups of HAVS with different levels of symptoms, were indicated by the randomized variance model. The most up-regulated genes were analyzed for their possible functions and association with the occurrence of HAVS. From the results of this pilot study, although the results were obtained a limited number of subjects, it would appear that cDNA microarray analysis of HAVS patients has potential as a new objective method of HAVS diagnosis. Further research is needed to examine the gene expression with increased numbers of patients at different stages of HAVS.

An open-label pilot study of granulocyte colony-stimulating factor for the treatment of severe endoscopic postoperative recurrence in Crohn's disease.

PubMed

Dejaco, Clemens; Lichtenberger, Conny; Miehsler, Wolfgang; Oberhuber, Georg; Herbst, Friedrich; Vogelsang, Harald; Gangl, Alfred; Reinisch, Walter

2003-01-01

Recombinant human granulocyte colony-stimulating factor (rhG-CSF) promoted healing of Crohn's disease (CD)-like intestinal lesions in chronic granulomatous disease and glycogen storage disease Ib, both characterized by defective neutrophil functions. We performed a prospective, open-label pilot study with rhG-CSF for the treatment of CD. Five patients with clinically inactive CD, but with severe endoscopic ileitis within 1 year after intestinal resection and ileocolonic anastomosis, received 300 microg of rhG-CSF (Filgrastim; Neupogen) subcutaneously, three times weekly for a total of 12 weeks. Safety was evaluated by assessment of clinical and laboratory data and disease activity. The primary parameter of efficacy was complete mucosal healing, as defined by the Rutgeerts score. Anti-inflammatory mediators were repeatedly measured during treatment. All patients completed the protocol in clinical remission. In 1 subject transient headache resolved after halving the rhG-CSF dosage. Complete mucosal healing was observed in 2 patients: in 1 patient after 12 weeks of therapy and in 1 patient 9 months after treatment cessation. In a single patient, closure of an anovaginal and of a perianal fistula was noted. Neutrophil counts and interleukin-1 receptor antagonist and soluble tumor necrosis factor receptor p55 and p75 levels were found to be increased during drug administration. rhG-CSF seems to be safe, well tolerated, and might provide efficacy in CD. Copyright 2003 S. Karger AG, Basel

Vitamin D concentrations in fortified foods and dietary supplements intended for infants: Implications for vitamin D intake.

PubMed

Verkaik-Kloosterman, Janneke; Seves, S Marije; Ocké, Marga C

2017-04-15

Due to potential overages to cover losses during shelf life, the actual vitamin D concentration of fortified foods and dietary supplements may deviate from the label. In this pilot study the vitamin D concentrations of fortified foods (n=29; follow-on formula, baby porridge, curd cheese dessert) and dietary supplements (n=15), both specifically intended for infants, were analytically determined. Compared to the declared values, the vitamin D content ranged from 50% to 153% for fortified foods and from 8% to 177% for supplements. In general, both instant follow-on formula and oil-based supplements had a measured vitamin D content similar to or higher than the labelled value. Ready-to-eat baby porridge was the only category in which all measured vitamin D concentrations were below the declared value (74-81%). The use of label information for fortified foods and dietary supplements may result in invalid estimations of vitamin D intake distributions of infants; both under- and overestimation may occur. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

A pilot study on the effect of a symbiotic mixture in irritable bowel syndrome: an open-label, partially controlled, 6-month extension of a previously published trial.

PubMed

Bucci, C; Tremolaterra, F; Gallotta, S; Fortunato, A; Cappello, C; Ciacci, C; Iovino, P

2014-04-01

In recent years, the efficacy of probiotics has received considerable attention in the treatment for irritable bowel syndrome (IBS). In this regard, a symbiotic mixture (Probinul(®)) has shown beneficial effects. The aim of this study was to extend the previously published 4-week randomized, double-blinded, placebo-controlled study of this symbiotic mixture. This is an open-label prospective, partially controlled, 6-month extension period pilot study in which patients continued to receive the symbiotic mixture (Group 1) or were switched from placebo to symbiotic mixture (Group 2) using cyclic administration (last 2 weeks/month). The primary endpoints were the overall satisfactory relief of bloating and flatulence (assessed as proportions of responders). The secondary endpoints were evaluation of the symptom severity scores (bloating, flatulence, pain and urgency) and bowel function scores (frequency, consistency and incomplete evacuation). Twenty-six IBS patients completed the 6-month extension period (13 patients in Group 1 and 13 patients in Group 2). In the per-protocol analysis, the proportions of responders across time were not significantly different in the groups but in Group 2, there was an increased percentage of responders for flatulence (p = 0.07). In addition, the score of flatulence was reduced significantly during the 6-month treatment period in Group 2 (p < 0.05), while no other significant differences were detected. Treatment with this symbiotic mixture was associated with persistence of relief from flatulence or new reduction in flatulence in the present 6-month long extension study. These results need to be more comprehensively assessed in large, long-term, randomized, placebo-controlled studies.

Aquatic therapy versus conventional land-based therapy for Parkinson's disease: an open-label pilot study.

PubMed

Vivas, Jamile; Arias, Pablo; Cudeiro, Javier

2011-08-01

To assess and compare 2 different protocols of physiotherapy (land or water therapy) for people with Parkinson's disease (PD) focused on postural stability and self-movement, and to provide methodological information regarding progression within the program for a future larger trial. Randomized, controlled, open-label pilot trial. Outpatients, Parkinson's disease Center of Ferrol-Galicia (Spain). Individuals (N=11) with idiopathic PD in stages 2 or 3 according to the Hoehn and Yahr Scale completed the investigation (intervention period plus follow-up). After baseline evaluations, participants were randomly assigned to a land-based therapy (active control group) or a water-based therapy (experimental group). Participants underwent individual sessions for 4 weeks, twice a week, for 45 minutes per session. Both interventions were matched in terms of exercise features, which were structured in stages with clear objectives and progression criteria to pass to the next phase. Participants underwent a first baseline assessment, a posttest immediately after 4 weeks of intervention, and a follow-up assessment after 17 days. Evaluations were performed OFF-dose after withholding medication for 12 hours. Functional assessments included the Functional Reach Test (FRT), the Berg Balance Scale (BBS), the UPDRS, the 5-m walk test, and the Timed Up and Go test. A main effect of both therapies was seen for the FRT. Only the aquatic therapy group improved in the BBS and the UPDRS. In this pilot study, physiotherapy protocols produced improvement in postural stability in PD that was significantly larger after aquatic therapy. The intervention protocols are shown to be feasible and seem to be of value in amelioration of postural stability-related impairments in PD. Some of the methodological aspects detailed here can be used to design larger controlled trials. Copyright © 2011 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

N-Acetylcysteine for Nonsuicidal Self-Injurious Behavior in Adolescents: An Open-Label Pilot Study.

PubMed

Cullen, Kathryn R; Klimes-Dougan, Bonnie; Westlund Schreiner, Melinda; Carstedt, Patricia; Marka, Nicholas; Nelson, Katharine; Miller, Michael J; Reigstad, Kristina; Westervelt, Ana; Gunlicks-Stoessel, Meredith; Eberly, Lynn E

2018-03-01

Nonsuicidal self-injury (NSSI) is common in adolescents and young adults, and few evidence-based treatments are available for this significant problem. N-acetylcysteine (NAC) is a widely available nutritional supplement that has been studied in some psychiatric disorders relevant to NSSI including mood and addictive disorders. This pilot study tested the use of NAC as a potential treatment for NSSI in youth. Thirty-five female adolescents and young adults with NSSI aged 13-21 years were enrolled in this study that had an open-label, single-arm study design. All participants were given oral NAC as follows: 600 mg twice daily (weeks 1-2), 1200 mg twice daily (weeks 3-4), and 1800 mg twice daily (weeks 5-8). Patients were seen every 2 weeks throughout the trial, at which time youth reported the frequency of NSSI episodes. Levels of depression, impulsivity, and global psychopathology were measured at baseline and at the end of the trial using the Beck Depression Inventory-II (BDI-II), Barratt Impulsivity Scale, and Symptoms Checklist-90 (SCL-90). About two-thirds of the enrolled female youth completed the trial (24/35). NAC was generally well tolerated in this sample. NAC treatment was associated with a significant decrease in NSSI frequency at visit 6 and visit 8 compared to baseline. We also found that depression scores and global psychopathology scores (but not impulsivity scores) decreased after NAC treatment. Decrease in NSSI was not correlated with decrease in BDI-II or SCL-90 scores, suggesting these might be independent effects. We provide preliminary evidence that NAC may have promise as a potential treatment option for adolescents with NSSI. The current results require follow-up with a randomized, placebo-controlled trial to confirm efficacy.

Chronic migraine headache prevention with noninvasive vagus nerve stimulation: The EVENT study.

PubMed

Silberstein, Stephen D; Calhoun, Anne H; Lipton, Richard B; Grosberg, Brian M; Cady, Roger K; Dorlas, Stefanie; Simmons, Kristy A; Mullin, Chris; Liebler, Eric J; Goadsby, Peter J; Saper, Joel R

2016-08-02

To evaluate the feasibility, safety, and tolerability of noninvasive vagus nerve stimulation (nVNS) for the prevention of chronic migraine (CM) attacks. In this first prospective, multicenter, double-blind, sham-controlled pilot study of nVNS in CM prophylaxis, adults with CM (≥15 headache d/mo) entered the baseline phase (1 month) and were subsequently randomized to nVNS or sham treatment (2 months) before receiving open-label nVNS treatment (6 months). The primary endpoints were safety and tolerability. Efficacy endpoints in the intent-to-treat population included change in the number of headache days per 28 days and acute medication use. Fifty-nine participants (mean age, 39.2 years; mean headache frequency, 21.5 d/mo) were enrolled. During the randomized phase, tolerability was similar for nVNS (n = 30) and sham treatment (n = 29). Most adverse events were mild/moderate and transient. Mean changes in the number of headache days were -1.4 (nVNS) and -0.2 (sham) (Δ = 1.2; p = 0.56). Twenty-seven participants completed the open-label phase. For the 15 completers initially assigned to nVNS, the mean change from baseline in headache days after 8 months of treatment was -7.9 (95% confidence interval -11.9 to -3.8; p < 0.01). Therapy with nVNS was well-tolerated with no safety issues. Persistent prophylactic use may reduce the number of headache days in CM; larger sham-controlled studies are needed. NCT01667250. This study provides Class II evidence that for patients with CM, nVNS is safe, is well-tolerated, and did not significantly change the number of headache days. This pilot study lacked the precision to exclude important safety issues or benefits of nVNS. © 2016 American Academy of Neurology.

Combination Varenicline and Lorcaserin for Tobacco Dependence Treatment and Weight Gain Prevention in Overweight and Obese Smokers: A Pilot Study.

PubMed

Hurt, Ryan T; Croghan, Ivana T; Schroeder, Darrell R; Hays, J Taylor; Choi, Doo-Sup; Ebbert, Jon O

2017-08-01

Post-cessation weight gain (PCWG) is a major barrier to maintaining abstinence, especially in weight-concerned smokers. Varenicline is the most effective medication for smoking cessation but has minimal impact on PCWG. Lorcaserin is an FDA-approved medication for weight management in overweight or obese patients which also provides a noticeable benefit in treating drug dependence. We hypothesized that combining varenicline with lorcaserin may help prevent PCWG. We conducted an open-label, single arm, Phase II clinical pilot study to obtain preliminary data on the safety and effectiveness of combination varenicline and lorcaserin in preventing PCWG in overweight and obese smokers. Twenty overweight or obese (body mass index 27-40 kg/m2) cigarette smokers were enrolled. The primary outcomes were weight and waist circumference (WC) changes at 12 and 26 weeks in smokers meeting criteria for prolonged smoking abstinence. All participants received open-label varenicline (1 mg twice a day) and lorcaserin (10 mg twice a day) for 12 weeks with follow-up at 26 weeks. Ten subjects met criteria for prolonged smoking abstinence at 12 weeks (50%) and 6 at 26 weeks (30%). Among those achieving prolonged smoking abstinence at 12 weeks, WC was +0.2 ± 6.0 cm (90% CI; -2.9, +3.4) and weight gain was +1.1 ± 3.9 kg (90% CI; -0.9, +3.1). Weight gain and WC increases following prolonged smoking abstinence may be reduced among overweight and obese smokers using combination varenicline and lorcaserin. This combinatory treatment warrants further research in the obese and weight-concerned smoking population. This is the first published prospective pilot study to evaluate lorcaserin for use in reducing PCWG in overweight and obese smokers. When combined with varenicline, lorcaserin minimized PCWG and increases in WC. In addition to the benefit on PCWG reduction, lorcaserin may be a potential new pharmacological treatment for smoking cessation and warrants further larger studies. © The Author 2016. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Using Plates and Trays with MyPlate Images to Encourage Healthy Food Choices: A Pilot Study at Military Dining Facilities

DTIC Science & Technology

dairy consumption . Future research should investigate the effectiveness of the MyPlate intervention for improving diet quality and nutrition knowledge in larger military dining facilities at different locations....introduced the new food labeling system. Dietary intake of facility patrons was measured during 12 lunch meals using the food photography method. Repeated...measures ANOVA, one-way ANOVA, paired t-test, and McNemars test were used. Results: Dairy consumption increased from baseline to intervention (0.50.4

Effect of mouth cleaning with hinokitiol-containing gel on oral malodor: a randomized, open-label pilot study.

PubMed

Iha, Kosaku; Suzuki, Nao; Yoneda, Masahiro; Takeshita, Toru; Hirofuji, Takao

2013-10-01

The aim of the study was to evaluate the effect of mouth cleaning with hinokitiol-containing gel on oral malodor. An open-label, randomized, controlled trial was conducted to assess oral malodor and clinical parameters related to oral malodor before and after mouth cleaning with hinokitiol-containing gel (n = 9) or with gel not including hinokitiol (n = 9). Mouth cleaning included the teeth, gingiva, and tongue and was carried out 3 times per day for 4 weeks. Organoleptic test (OLT) scores (P = .021), levels of hydrogen sulfide (P = .008) and methyl mercaptan (P = .020), frequency of bleeding on probing, average probing pocket depth, and plaque index significantly improved in the group using hinokitiol. In contrast, only the OLT score (P = .031) significantly improved in the control group after the treatment regimen. Mouth cleaning with hinokitiol-containing gel may be effective for reduction of oral malodor. Copyright © 2013 Elsevier Inc. All rights reserved.

U.S. EPA, Pesticide Product Label, BROM-O-GAS 0.5%, 04/18/1975

EPA Pesticide Factsheets

2011-04-14

... 1 "II c'1"rlllll!C. • III ""t' "I ,','lIlact \\\\.1,,11 '''"l rlillr"lIl!hl\\ \\11 Iii ,,'ap J::d \\l,il,'1 t'll .11 1e.1" !.:; Illllllllc" Rt'I:?,)\\ __ 'IILtlll':',llc'd :1'>1ilt" Jilt! ... pilot 114hts Jilt! ...

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.

Safety and tolerability of varenicline tartrate (Champix(®)/Chantix(®)) for smoking cessation in HIV-infected subjects: a pilot open-label study.

PubMed

Cui, Qu; Robinson, Linda; Elston, Dawn; Smaill, Fiona; Cohen, Jeffrey; Quan, Corinna; McFarland, Nancy; Thabane, Lehana; McIvor, Andrew; Zeidler, Johannes; Smieja, Marek

2012-01-01

The prevalence of smoking in HIV-infected subjects is high. As a smoking cessation aid, varenicline (Champix(®), Pfizer, Saint-Laurent, QC, Canada or Chantix(®), Pfizer, Mission, KS) has not been previously evaluated in HIV-infected smokers. In this multicenter pilot open label study, varenicline 1.0 mg was used twice daily for 12 weeks with dose titration in the first week. Adverse events (AEs) during the treatment period were recorded. Changes from baseline in laboratory tests, vital signs, daily cigarette consumption, nicotine dependence, and withdrawal were measured through week 24. Self-reported abstinence was validated by serum cotinine at week 12. We enrolled 36 subjects with a mean of 29 pack-years of smoking and a minimum of 4 cigarettes per day. All but 1 were male, 33 (92%) were white. The most frequently reported AEs were nausea (33%), abnormal dreams (31%), affect lability (19%), and insomnia (19%). Six (17%) subjects discontinued varenicline due to AEs. No grade 3/4 laboratory abnormalities or serious AEs occurred during the study. There was no significant change in HIV viral load. CD4 counts increased by 69 cells/mm3 (p = 0.001) at week 24. Serum cotinine-verified 4-week continuous abstinence rate through weeks 9-12 was 42% (95% confidence interval [CI]: 26-58%). AEs and abstinence rates were comparable to those in published randomized controlled trials conducted in generally healthy HIV-negative smokers. Varenicline was safe and appears effective among HIV-infected smokers in this exploratory study, although AEs were common. The most common AE was nausea, with no adverse effect on HIV treatment outcome. Close monitoring of liver enzymes and blood pressure is recommended for HIV-positive smokers taking varenicline.

Safety and Tolerability of Varenicline Tartrate (Champix®/Chantix®) for Smoking Cessation in HIV-Infected Subjects: A Pilot Open-Label Study

PubMed Central

Robinson, Linda; Elston, Dawn; Smaill, Fiona; Cohen, Jeffrey; Quan, Corinna; McFarland, Nancy; Thabane, Lehana; McIvor, Andrew; Zeidler, Johannes; Smieja, Marek

2012-01-01

Abstract The prevalence of smoking in HIV-infected subjects is high. As a smoking cessation aid, varenicline (Champix®, Pfizer, Saint-Laurent, QC, Canada or Chantix®, Pfizer, Mission, KS) has not been previously evaluated in HIV-infected smokers. In this multicenter pilot open label study, varenicline 1.0 mg was used twice daily for 12 weeks with dose titration in the first week. Adverse events (AEs) during the treatment period were recorded. Changes from baseline in laboratory tests, vital signs, daily cigarette consumption, nicotine dependence, and withdrawal were measured through week 24. Self-reported abstinence was validated by serum cotinine at week 12. We enrolled 36 subjects with a mean of 29 pack-years of smoking and a minimum of 4 cigarettes per day. All but 1 were male, 33 (92%) were white. The most frequently reported AEs were nausea (33%), abnormal dreams (31%), affect lability (19%), and insomnia (19%). Six (17%) subjects discontinued varenicline due to AEs. No grade 3/4 laboratory abnormalities or serious AEs occurred during the study. There was no significant change in HIV viral load. CD4 counts increased by 69 cells/mm3 (p=0.001) at week 24. Serum cotinine-verified 4-week continuous abstinence rate through weeks 9–12 was 42% (95% confidence interval [CI]: 26–58%). AEs and abstinence rates were comparable to those in published randomized controlled trials conducted in generally healthy HIV-negative smokers. Varenicline was safe and appears effective among HIV-infected smokers in this exploratory study, although AEs were common. The most common AE was nausea, with no adverse effect on HIV treatment outcome. Close monitoring of liver enzymes and blood pressure is recommended for HIV-positive smokers taking varenicline. PMID:22007690

Forest Soil Respiration: Identifying Sources and Controls

NASA Astrophysics Data System (ADS)

Högberg, P.

2008-12-01

Most of the respiration in forests comes from the soil. This flux is composed of two components, autotrophic and heterotrophic respiration. In a strict sense the former should be plant belowground respiration only, but the term is used here to denote respiration by roots, their mycorrhizal fungal symbionts and other closely associated organisms dependent on recent photosynthate. Heterotrophs are organisms using organic matter, chiefly above- and belowground litters, as substrate (i.e. substrates of in general much higher ecosystem age). Because of the complexity of the plant-soil system, the component fluxes are difficult to study. I will discuss results of different approaches to partition soil respiratory components and to study their controls. The focus will be on northern boreal forests. In these generally strongly nitrogen-limited forests, the autotrophic respiration equals or exceeds the heterotrophic component. The large autotrophic component reflects high plant allocation of C to roots and mycorrhizal fungi in response to the low N supply. A physiological manipulation, girdling, which stops the flow of photosynthates to roots, showed that autotrophic respiration could account for as much as 70% in N-limited forests, but only 40% in fertilized forests. Also using girdling, we could show that a shift to lower summertime temperature leads to a decrease in heterotrophic but not in autotrophic activity, suggesting substrate (photosynthate) limitation of the latter. Physiological manipulations like girdling and trenching cannot be used to reveal the finer details of soil C dynamics. Natural abundance stable isotope (13C) and 14C approaches also have their limitations if a high resolution in terms of time, space and organism is required. A very high resolution can, of course, be obtained in studies of laboratory micro- or mesocosms, but the possibility to extend the interpretation of their results to the field may be questioned. In the CANIFLEX (CArbon NItrogen Forest Labelling Experiment) project, we use a short labelling period and highly enriched 13CO2 to produce a traceable pulse through components of the system directly in the field. Thus, we have labelled 50 m2 plots using 4-5 tall plastic chambers (i.e. 200-250 m3) in a young Scots pine forest. Results of a pilot study in 2006 have been published (Högberg et al. 2008 New Phytol.). The CANIFLEX project has shown that traceable quantities of labelled C peak within a few days in ectomycorrhizal roots, microbial cytoplasm and soil respiratory efflux. In the two latter, the C had a half-life of 280 h and 35 h, respectively. Using higher tracer levels than in the pilot study, we have now successfully conducted stable isotope probing of specific groups of soil organisms at this large scale, finding 13C tracer in PLFA (phospholipid fatty acid) biomarkers for fungi, but not in the majority of markers for bacteria. We are now into our second season of following the effects of additions of N on the belowground C dynamics using a combined 13C (photosynthate) and 15N (labelling of soil N) approach. The physiological and labelling approaches are complementary, but need to be linked through modelling. This is a major challenge.

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

A 52-week pilot study of the effects of exenatide on body weight in patients with hypothalamic obesity.

PubMed

Lomenick, Jefferson P; Buchowski, Maciej S; Shoemaker, Ashley H

2016-06-01

Hypothalamic obesity (HO) is a common complication of hypothalamic tumors, and effective therapies are lacking. The objective of this pilot study was to investigate changes in body weight before and during treatment with exenatide. This was a prospective, open-label, 52-week pilot study of exenatide (10 mcg b.i.d.) in adults with HO. Ten patients enrolled, and eight completed the study. Study measures included indirect calorimetry, body composition, buffet meals, diet recall, actigraphy, and hormone assays. Participants had obesity with a baseline weight of 137.2 ± 37.6 kg. Exenatide therapy was well tolerated. Change in weight with exenatide therapy was not significant (-1.4 ± 4.3 kg [95% CI -4.9 to 2.2], P = 0.40), but six out of eight completers lost weight (-6.2 to -0.2 kg). Participants reported significantly lower intake on food recall during treatment compared with baseline (7837.8 ± 2796.6 vs. 6258.4 ± 1970.7 kJ [95% CI -2915.8 to -242.6], P = 0.027), but there was no change in intake during buffet meals. Significant weight loss was not observed in patients with HO treated with exenatide, but 75% of completers had stable or decreasing weight. Further studies are needed to evaluate weight loss efficacy in patients with HO. © 2016 The Obesity Society.

The Psychedelic Debriefing in Alcohol Dependence Treatment: Illustrating Key Change Phenomena through Qualitative Content Analysis of Clinical Sessions

PubMed Central

Nielson, Elizabeth M.; May, Darrick G.; Forcehimes, Alyssa A.; Bogenschutz, Michael P.

2018-01-01

Research on the clinical applications of psychedelic-assisted psychotherapy has demonstrated promising early results for treatment of alcohol dependence. Detailed description of the content and methods of psychedelic-assisted psychotherapy, as it is conducted in clinical settings, is scarce. Methods: An open-label pilot (proof-of-concept) study of psilocybin-assisted treatment of alcohol dependence (NCT01534494) was conducted to generate data for a phase 2 RCT (NCT02061293) of a similar treatment in a larger population. The present paper presents a qualitative content analysis of the 17 debriefing sessions conducted in the pilot study, which occurred the day after corresponding psilocybin medication sessions. Results: Participants articulated a series of key phenomena related to change in drinking outcomes and acute subjective effects of psilocybin. Discussion: The data illuminate change processes in patients' own words during clinical sessions, shedding light on potential therapeutic mechanisms of change and how participants express effects of psilocybin. This study is unique in analyzing actual clinical sessions, as opposed to interviews of patients conducted separately from treatment. PMID:29515449

Academic-Community Partnership to Develop a Patient-Centered Breast Cancer Risk Reduction Program for Latina Primary Care Patients.

PubMed

Castañeda, Sheila F; Giacinto, Rebeca E; Medeiros, Elizabeth A; Brongiel, Ilana; Cardona, Olga; Perez, Patricia; Talavera, Gregory A

2016-06-01

This collaborative study sought to address Latina breast cancer (BC) disparities by increasing health literacy (HL) in a community health center situated on the US-Mexico border region of San Diego County. An academic-community partnership conducted formative research to develop a culturally tailored promotora-based intervention with 109 individuals. The Spanish language program, entitled Nuestra Cocina: Mesa Buena, Vida Sana (Our Kitchen: Good Table, Healthy Life), included six sessions targeting HL, women's health, BC risk reduction, and patient-provider communication; sessions include cooking demonstrations of recipes with cancer-risk-reducing ingredients. A pilot study with 47 community health center Latina patients was conducted to examine the program's acceptability, feasibility, and ability to impact knowledge and skills. Pre- and post-analyses demonstrated that participants improved their self-reported cancer screening, BC knowledge, daily fruit and vegetable intake, and ability to read a nutrition label (p < 0.05). Results of the pilot study demonstrate the importance of utilizing patient-centered culturally appropriate noninvasive means to educate and empower Latina patients.

Academic-Community Partnership to Develop a Patient-Centered Breast Cancer Risk Reduction Program for Latina Primary Care Patients

PubMed Central

Castañeda, Sheila F.; Giacinto, Rebeca E.; Medeiros, Elizabeth A.; Brongiel, Ilana; Cardona, Olga; Perez, Patricia; Talavera, Gregory A.

2015-01-01

This collaborative study sought to address Latina breast cancer (BC) disparities by increasing health literacy (HL) in a community health center situated on the US-Mexico border region of San Diego County. An academic-community partnership conducted formative research to develop a culturally tailored promotora-based intervention with 109 individuals. The Spanish language program, entitled Nuestra Cocina: Mesa Buena, Vida Sana (Our Kitchen: Good Table, Healthy Life), included six sessions targeting HL, women’s health, BC risk reduction, and patient-provider communication; sessions include cooking demonstrations of recipes with cancer-risk-reducing ingredients. A pilot study with 47 community health center Latina patients was conducted to examine the program’s acceptability, feasibility, and ability to impact knowledge and skills. Pre- and post-analyses demonstrated that participants improved their self-reported cancer screening, BC knowledge, daily fruit and vegetable intake, and ability to read a nutrition label (p<0.05). Results of the pilot study demonstrate the importance of utilizing patient-centered culturally appropriate noninvasive means to educate and empower Latina patients. PMID:27271058

Double-blind optimization of subcallosal cingulate deep brain stimulation for treatment-resistant depression: a pilot study.

PubMed

Ramasubbu, Rajamannar; Anderson, Susan; Haffenden, Angela; Chavda, Swati; Kiss, Zelma H T

2013-09-01

Deep brain stimulation (DBS) of the subcallosal cingulate (SCC) is reported to be a safe and effective new treatment for treatment-resistant depression (TRD). However, the optimal electrical stimulation parameters are unknown and generally selected by trial and error. This pilot study investigated the relationship between stimulus parameters and clinical effects in SCC-DBS treatment for TRD. Four patients with TRD underwent SCC-DBS surgery. In a double-blind stimulus optimization phase, frequency and pulse widths were randomly altered weekly, and corresponding changes in mood and depression were evaluated using a visual analogue scale (VAS) and the 17-item Hamilton Rating Scale for Depression (HAM-D-17). In the open-label postoptimization phase, depressive symptoms were evaluated biweekly for 6 months to determine long-term clinical outcomes. Longer pulse widths (270-450 μs) were associated with reductions in HAM-D-17 scores in 3 patients and maximal happy mood VAS responses in all 4 patients. Only 1 patient showed acute clinical or mood effects from changing the stimulation frequency. After 6 months of open-label therapy, 2 patients responded and 1 patient partially responded. Limitations include small sample size, weekly changes in stimulus parameters, and fixed-order and carry-forward effects. Longer pulse width stimulation may have a role in stimulus optimization for SCC-DBS in TRD. Longer pulse durations produce larger apparent current spread, suggesting that we do not yet know the optimal target or stimulus parameters for this therapy. Investigations using different stimulus parameters are required before embarking on large-scale randomized sham-controlled trials.

An open-label pilot study of aripiprazole for male and female veterans with chronic post-traumatic stress disorder who respond suboptimally to antidepressants.

PubMed

Youssef, Nagy A; Marx, Christine E; Bradford, Daniel W; Zinn, Sandra; Hertzberg, Michael A; Kilts, Jason D; Naylor, Jennifer C; Butterfield, Marian I; Strauss, Jennifer L

2012-07-01

Emerging data suggest that second-generation antipsychotics such as aripiprazole may be effective in the treatment of post-traumatic stress disorder (PTSD). However, few clinical trials have used aripiprazole in PTSD, and data are limited on its use in Veterans with PTSD. The objective of this pilot trial was to investigate the safety and efficacy of aripiprazole in Veterans with PTSD. Ten individuals (five men and five women) meeting the Diagnostic and statistical manual of mental disorders, 4th ed., PTSD criteria participated in this 12-week, open-label, flexibly dosed monotherapy trial. The dose range of aripiprazole was 5-30 mg/day, titrated to tolerability and clinical response. The primary outcome measure was the Clinician-Administered PTSD Scale. Additional outcomes included the Short PTSD Rating Interview, the Treatment Outcome PTSD Scale (Top-8), the Davidson Trauma Scale, the Positive and Negative Syndrome Scale, the Beck Depression Inventory-Fast Screen, and Clinical Global Impressions-Improvement. Eight participants completed the study, and aripiprazole was generally well tolerated and associated with a significant improvement in PTSD symptoms, as measured by the Clinician-Administered PTSD Scale (primary outcome measure) and by the Short PTSD Rating Interview, the Treatment Outcome PTSD Scale, and the Davidson Trauma Scale. An improvement was also observed on all three Positive and Negative Syndrome Scale subscales and the Beck Depression Inventory-Fast Screen, and the average Clinical Global Impressions-Improvement ratings indicated that patients were 'much improved'. These promising initial results merit further investigation in a larger, randomized-controlled trial.

Lumbar spine intervertebral disc gene delivery: a pilot study in lewis rats.

PubMed

Damle, Sheela R; Rawlins, Bernard A; Boachie-Adjei, Oheneba; Crystal, Ronald G; Hidaka, Chisa; Cunningham, Matthew E

2013-02-01

Basic research toward understanding and treating disc pathology in the spine has utilized numerous animal models, with delivery of small molecules, purified factors, and genes of interest. To date, gene delivery to the rat lumbar spine has only been described utilizing genetically programmed cells in a matrix which has required partial disc excision, and expected limitation of treatment diffusion into the disc. This study was designed to develop and describe a surgical technique for lumbar spine exposure and disc space preparation, and use of a matrix-free method for gene delivery. Naïve or genetically programmed isogeneic bone marrow stromal cells were surgically delivered to adolescent male Lewis rat lumbar discs, and utilizing quantitative biochemical and qualitative immunohistological assessments, the implanted cells were detected 3 days post-procedure. Statistically significant differences were noted for recovery of the β-galactosidase marker gene comparing delivery of naïve or labeled cells (10(5) cells per disc) from the site of implantation, and between delivery of 10(5) or 10(6) labeled cells per disc at the site of implantation and the adjacent vertebral body. Immunohistology confirmed that the β-galactosidase marker was detected in the adjacent vertebra bone in the zone of surgical implantation. The model requires further testing in larger cohorts and with biologically active genes of interest, but the observations from the pilot experiments are very encouraging that this will be a useful comparative model for basic spine research involving gene or cell delivery, or other locally delivered therapies to the intervertebral disc or adjacent vertebral bodies in rats.

Simvastatin as an Adjunct to Conventional Therapy of Non-infectious Uveitis: A Randomized, Open-Label Pilot Study.

PubMed

Shirinsky, Ivan V; Biryukova, Anastasia A; Shirinsky, Valery S

2017-12-01

Statins have been shown to reduce ocular inflammation in animal models of uveitis and to prevent development of uveitis in observational studies. There have been no experimental human studies evaluating statins' efficacy and safety in uveitis. In this study, we aimed to investigate efficacy and safety of simvastatin in patients with uveitis. For this single-center, open-label, randomized study, we enrolled patients with acute non-infectious uveitis. The patients were randomized to receive 40 mg simvastatin per day for 2 months in addition to conventional treatment or conventional treatment alone. The studied outcomes were the rate of steroid-sparing control of ocular inflammation, measures of ocular inflammation, intraocular pressure, and visual acuity. Fifty patients were enrolled in the study. Twenty-five patients were randomly assigned to receive simvastatin with conventional treatment and 25 to conventional treatment alone. Simvastatin was associated with significantly higher rates of steroid-sparing ocular inflammation control, decrease in anterior chamber inflammation, and improvement in visual acuity. The treatment was well tolerated, no serious adverse effects were observed. Our findings suggest that statins may have therapeutic potential in uveitis. These results need to be confirmed in double-blind, randomized, controlled studies.

Clustering Analysis of Common Tasks Undertaken by Engineering Technicians in Informatics and Manufacturing in Seven European Countries

ERIC Educational Resources Information Center

Papadourakis, George M.; Natsika, Christina; Magnan, Myrna; Barsics, Joseph

2008-01-01

VALEURTECH is a pilot project under the European Commission's Leonardo II programme. It includes 35 partners from higher education institutions and professional organizations in eight European countries and has the major objectives: of (a) setting up a homogeneous "labelling" process, such as a diploma supplement, based on a common…

Handling Qualities of Large Rotorcraft in Hover and Low Speed

DTIC Science & Technology

2015-03-01

stability derivative terms (e.g., ). These gravitational and inertial Coriolis effects are accounted for separately in the blocks labeled...dynamic effects and output them as part of its linearization routines. Although the analytical process omitted certain effects to make the definition and... Effect of Pilot Longitudinal Position Offset in ACAH ................................................................ 54 Control System Design

Changes in Psychological Parameters in Patients with Tension-type Headache Following Massage Therapy: A Pilot Study

PubMed Central

Moraska, Albert; Chandler, Clint

2009-01-01

Investigations into complementary and alternative medicine (CAM) approaches to address stress, depression, and anxiety of those experiencing chronic pain are rare. The objective of this pilot study was to assess the value of a structured massage therapy program, with a focus on myofascial trigger points, on psychological measures associated with tension-type headache. Participants were enrolled in an open-label trial using a baseline control with four 3-week phases: baseline, massage (two 3-week periods) and a follow-up phase. Eighteen subjects with episodic or chronic tension-type headache were enrolled and evaluated at 3-week intervals using the State-Trait Anxiety Inventory, Beck Depression Inventory, and the Perceived Stress Scale. The Daily Stress Inventory was administered over 7-day periods during baseline and the final week of massage. Twice weekly, 45-minute massage therapy sessions commenced following the baseline phase and continued for 6 weeks. A significant improvement in all psychological measures was detected over the timeframe of the study. Post hoc evaluation indicated improvement over baseline for depression and trait anxiety following 6 weeks of massage, but not 3 weeks. A reduction in the number of events deemed stressful as well as their respective impact was detected. This pilot study provides evidence for reduction of affective distress in a chronic pain population, suggesting the need for more rigorously controlled studies using massage therapy to address psychological measures associated with TTH. PMID:20046550

Counseling to Prevent Obesity Among Preschool Children: Acceptability of a Pilot Urban Primary Care Intervention

PubMed Central

McKee, M. Diane; Maher, Stacia; Deen, Darwin; Blank, Arthur E.

2010-01-01

PURPOSE To help design effective primary care-based interventions, we explored urban parents’ reactions to a pilot and feasibility study designed to address risk behaviors for obesity among preschool children. METHODS We conducted 3 focus groups (2 in English, 1 in Spanish) to evaluate the pilot intervention. Focus group participants explored the acceptability of the pilot intervention components (completion of a new screening tool for risk assessment, discussion of risk behaviors and behavior change goal setting by physicians, and follow-up contacts with a lifestyle counselor) and the fidelity of the pilot intervention delivery. RESULTS Parents expressed a desire to change behaviors to achieve healthier families. They believed that doctors should increase their focus on healthy habits during visits. Parents were more accepting of nutrition discussions than increasing activity (citing a lack of safe outdoor space) or decreasing sedentary behaviors (citing many benefits of television viewing). Contacts with the lifestyle counselor were described as empowering, with parents noting her focus on strategies to achieve change for the whole family while recognizing that many food behaviors relate to cultural heritage. Parents expressed frustration with physicians for offering advice about changing behavior but not how to achieve it, for dismissing concerns about picky eating or undereating, and in some cases for labels of overweight that they believed were inappropriately applied. CONCLUSIONS Parents welcomed efforts to address family lifestyle change in pediatric visits. The model of physician goal setting with referral for behavior change counseling is highly acceptable to families. Future interventions should acknowledge parental concerns about undereating and perceived benefits of television viewing. PMID:20458109

A Randomized Controlled Open-Label Pilot Study of Simvastatin Addition to Whole-Brain Radiation Therapy in Patients With Brain Metastases.

PubMed

El-Hamamsy, Manal; Elwakil, Hesham; Saad, Amr S; Shawki, May A

2016-10-27

Statins have been reported to have a potential radiosensitizing effect that has not been evaluated in clinical trials. The aim of this study was to evaluate the efficacy and safety of simvastatin in addition to whole-brain radiation therapy (WBRT) in patients with brain metastases (BM). A prospective randomized, controlled, open-label pilot study was conducted on 50 Egyptian patients with BM who were randomly assigned to receive 30-Gy WBRT (control group: 25 patients) or 30 Gy WBRT + simvastatin 80 mg/day for the WBRT period (simvastatin group: 25 patients). The primary outcome was radiological response at 4 weeks after WBRT. Secondary outcomes were 1-year progression-free survival (PFS), 1-year overall survival (OS), and health-related quality of life (HRQL) that was assessed using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) and its brain module (BN-20), at baseline, after WBRT, and 4 weeks after WBRT. The addition of simvastatin was tolerated. Twenty-one patients were not evaluated for radiological response because of death (n = 16), noncompliance to follow-up (n = 4), and clinical deterioration (n = 1). Response rates were 60% and 78.6% (p = 0.427), 1-year PFS rates were 5.2% and 17.7% (p = 0.392), and 1-year OS rates were 12% and 8% (p = 0.880) for the control group and simvastatin group, respectively. Nonsignificant differences were found between the two arms regarding HRQL scales. The addition of simvastatin 80 mg/day did not improve the clinical outcomes of patients with BM receiving WBRT.

An Open-Label Pilot Study of Combined Augmentation With Creatine Monohydrate and 5-Hydroxytryptophan for Selective Serotonin Reuptake Inhibitor- or Serotonin-Norepinephrine Reuptake Inhibitor-Resistant Depression in Adult Women.

PubMed

Kious, Brent M; Sabic, Hana; Sung, Young-Hoon; Kondo, Douglas G; Renshaw, Perry

2017-10-01

Many women with major depressive disorder (MDD) respond inadequately to standard treatments. Augmentation of conventional antidepressants with creatine monohydrate and 5-hydroxytryptophan (5-HTP) could correct deficits in serotonin production and brain bioenergetics associated with depression in women, yielding synergistic benefit. We describe an open-label study of 5-HTP and creatine augmentation in women with MDD who had failed selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) monotherapy. Fifteen women who were adequately adherent to an SSRI or SNRI and currently experiencing MDD, with a 17-item Hamilton Depression Rating Scale (HAM-D) score of 16 or higher, were treated with 5 g of creatine monohydrate daily and 100 mg of 5-HTP twice daily for 8 weeks, with 4 weeks of posttreatment follow-up. The primary outcome was change in mean HAM-D scores. Mean HAM-D scores declined from 18.9 (SD, 2.5) at pretreatment visits to 7.5 (SD, 4.4) (P < 0.00001), a decrease of 60%. Participants did not experience any serious treatment-related adverse events. Combination treatment with creatine and 5-HTP may represent an effective augmentation strategy for women with SSRI- or SNRI-resistant depression. Given the limitations of this small, open-label trial, future study in randomized, placebo-controlled trials is warranted.

Music to my ears: Age-related decline in musical and facial emotion recognition.

PubMed

Sutcliffe, Ryan; Rendell, Peter G; Henry, Julie D; Bailey, Phoebe E; Ruffman, Ted

2017-12-01

We investigated young-old differences in emotion recognition using music and face stimuli and tested explanatory hypotheses regarding older adults' typically worse emotion recognition. In Experiment 1, young and older adults labeled emotions in an established set of faces, and in classical piano stimuli that we pilot-tested on other young and older adults. Older adults were worse at detecting anger, sadness, fear, and happiness in music. Performance on the music and face emotion tasks was not correlated for either age group. Because musical expressions of fear were not equated for age groups in the pilot study of Experiment 1, we conducted a second experiment in which we created a novel set of music stimuli that included more accessible musical styles, and which we again pilot-tested on young and older adults. In this pilot study, all musical emotions were identified similarly by young and older adults. In Experiment 2, participants also made age estimations in another set of faces to examine whether potential relations between the face and music emotion tasks would be shared with the age estimation task. Older adults did worse in each of the tasks, and had specific difficulty recognizing happy, sad, peaceful, angry, and fearful music clips. Older adults' difficulties in each of the 3 tasks-music emotion, face emotion, and face age-were not correlated with each other. General cognitive decline did not appear to explain our results as increasing age predicted emotion performance even after fluid IQ was controlled for within the older adult group. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Users manual for the US baseline corn and soybean segment classification procedure

NASA Technical Reports Server (NTRS)

Horvath, R.; Colwell, R. (Principal Investigator); Hay, C.; Metzler, M.; Mykolenko, O.; Odenweller, J.; Rice, D.

1981-01-01

A user's manual for the classification component of the FY-81 U.S. Corn and Soybean Pilot Experiment in the Foreign Commodity Production Forecasting Project of AgRISTARS is presented. This experiment is one of several major experiments in AgRISTARS designed to measure and advance the remote sensing technologies for cropland inventory. The classification procedure discussed is designed to produce segment proportion estimates for corn and soybeans in the U.S. Corn Belt (Iowa, Indiana, and Illinois) using LANDSAT data. The estimates are produced by an integrated Analyst/Machine procedure. The Analyst selects acquisitions, participates in stratification, and assigns crop labels to selected samples. In concert with the Analyst, the machine digitally preprocesses LANDSAT data to remove external effects, stratifies the data into field like units and into spectrally similar groups, statistically samples the data for Analyst labeling, and combines the labeled samples into a final estimate.

Development of cockroach immunotherapy by the Inner-City Asthma Consortium

PubMed Central

Wood, Robert A.; Togias, Alkis; Wildfire, Jeremy; Visness, Cynthia M.; Matsui, Elizabeth C.; Gruchalla, Rebecca; Hershey, Gurjit; Liu, Andrew H.; O’Connor, George T.; Pongracic, Jacqueline A.; Zoratti, Edward; Little, Frederic; Granada, Mark; Kennedy, Suzanne; Durham, Stephen R.; Shamji, Mohamed H.; Busse, William W.

2014-01-01

Background Cockroach allergy is a key contributor to asthma morbidity in children living in urban environments. Objective We sought to document immune responses to cockroach allergen and provide direction for the development of immunotherapy for cockroach allergy. Methods Four pilot studies were conducted: (1) an open-label study to assess the safety of cockroach sublingual immunotherapy (SLIT) in adults and children; (2) a randomized, double-blind biomarker study of cockroach SLIT versus placebo in adults; (3) a randomized, double-blind biomarker study of 2 doses of cockroach SLIT versus placebo in children; and (4) an open-label safety and biomarker study of cockroach subcutaneous immunotherapy (SCIT) in adults. Results The adult SLIT trial (n = 54; age, 18–54 years) found a significantly greater increase in cockroach-specific IgE levels between the active and placebo groups (geometric mean ratio, 1.92; P < .0001) and a trend toward increased cockroach-specific IgG4 levels in actively treated subjects (P = .09) but no evidence of functional blocking antibody response. The pediatric SLIT trial (n = 99; age, 5–17 years) found significant differences in IgE, IgG, and IgG4 responses between both active groups and the placebo group but no consistent differences between the high- and low-dose groups. In the SCIT study the treatment resulted in significant changes from baseline in cockroach IgE, IgG4, and blocking antibody levels. The safety profile of cockroach immunotherapy was reassuring in all studies. Conclusions The administration of cockroach allergen by means of SCIT is immunologically more active than SLIT, especially with regard to IgG4 levels and blocking antibody responses. No safety concerns were raised in any age group. These pilot studies suggest that immunotherapy with cockroach allergen is more likely to be effective with SCIT. PMID:24184147

Biomagnetic Pair Therapy and Typhoid Fever: A Pilot Study.

PubMed

Frank, Bryan L

2017-10-01

Objective: This pilot study examined the laboratory responses of patients with laboratory-documented typhoid fever who were treated with Biomagnetic Pair Therapy (BPT; medical biomagnetism), a specific application of pairs of magnets for various ailments that are infectious and otherwise. Materials and Methods: This study was an assessment of patients' response to treatment with only BPT for Salmonella typhi infections (typhoid fever) using standard conventional laboratory techniques. The research was conducted in an outpatient village clinic in Kenya. There were 52 participants who were evaluated for possible systemic illness, including typhoid fever, from an open-label study. Participants who felt sick and requested testing for possible typhoid fever were tested with a standard Widal test by a certified laboratory technician. Participants who tested positive (13 patients) were then treated with BPT (a "First Aid" approach) only. These participants then returned for follow-up laboratory and clinical evaluations after 2 days. Results: Most of the participants (10 of 13) retested as negative, and all patients reported symptomatic clinical improvement. Conclusions: As a significant majority of participants demonstrated clearing of their S. typhi after BPT, this technique should be studied further in larger trials for its efficacy in treating typhoid fever.

A pilot study of serotonergic modulation after long-term administration of oxytocin in autism spectrum disorder.

PubMed

Hirosawa, Tetsu; Kikuchi, Mitsuru; Ouchi, Yasuomi; Takahashi, Tetsuya; Yoshimura, Yuko; Kosaka, Hirotaka; Furutani, Naoki; Hiraishi, Hirotoshi; Fukai, Mina; Yokokura, Masamichi; Yoshikawa, Etsuji; Bunai, Tomoyasu; Minabe, Yoshio

2017-05-01

Oxytocin (OT) and the serotonergic system putatively play important roles in autism spectrum disorder (ASD) etiology and symptoms, but no direct neurobiological evidence exists for long-term OT administration effects on the brain's serotonergic system. This pilot study examined 10 male participants with ASD who were administered OT intranasally for 8-10 weeks in an open-label, single-arm, nonrandomized, and uncontrolled manner. Positron emission tomography (PET) with a radiotracer ( 11 C)-3-amino-4-(2-[(dimethylamino)methyl]phenylthio)benzonitrile ( 11 C-DASB) was used before and after OT treatment. The binding potential of serotonin transporter ( 11 C-DASB BP ND ) was then estimated. The main outcome measures were changes in 11 C-DASB BP ND and their correlation with changes in symptoms. ASD participants showed significantly elevated 11 C-DASB BP ND in the left inferior frontal gyrus extending to the left middle frontal gyrus. No significant correlation was found between the change in any clinical symptom and the change in 11 C-DASB BP ND . This report of a pilot study is the first describing long-term effects of OT on the brain's serotonin system in ASD. Additional randomized controlled studies must be conducted to confirm whether activation of the serotonergic system contributes to the prosocial effect of OT in people with ASD. Autism Res 2017, 10: 821-828. © 2017 International Society for Autism Research, Wiley Periodicals, Inc. © 2017 International Society for Autism Research, Wiley Periodicals, Inc.

Performance evaluation of multi-material electronic cleansing for ultra-low-dose dual-energy CT colonography

NASA Astrophysics Data System (ADS)

Tachibana, Rie; Kohlhase, Naja; Näppi, Janne J.; Hironaka, Toru; Ota, Junko; Ishida, Takayuki; Regge, Daniele; Yoshida, Hiroyuki

2016-03-01

Accurate electronic cleansing (EC) for CT colonography (CTC) enables the visualization of the entire colonic surface without residual materials. In this study, we evaluated the accuracy of a novel multi-material electronic cleansing (MUMA-EC) scheme for non-cathartic ultra-low-dose dual-energy CTC (DE-CTC). The MUMA-EC performs a wateriodine material decomposition of the DE-CTC images and calculates virtual monochromatic images at multiple energies, after which a random forest classifier is used to label the images into the regions of lumen air, soft tissue, fecal tagging, and two types of partial-volume boundaries based on image-based features. After the labeling, materials other than soft tissue are subtracted from the CTC images. For pilot evaluation, 384 volumes of interest (VOIs), which represented sources of subtraction artifacts observed in current EC schemes, were sampled from 32 ultra-low-dose DE-CTC scans. The voxels in the VOIs were labeled manually to serve as a reference standard. The metric for EC accuracy was the mean overlap ratio between the labels of the reference standard and the labels generated by the MUMA-EC, a dualenergy EC (DE-EC), and a single-energy EC (SE-EC) scheme. Statistically significant differences were observed between the performance of the MUMA/DE-EC and the SE-EC methods (p<0.001). Visual assessment confirmed that the MUMA-EC generated less subtraction artifacts than did DE-EC and SE-EC. Our MUMA-EC scheme yielded superior performance over conventional SE-EC scheme in identifying and minimizing subtraction artifacts on noncathartic ultra-low-dose DE-CTC images.

Use of Bisphenol A-containing baby bottles in Cameroon and Nigeria and possible risk management and mitigation measures: community as milestone for prevention.

PubMed

Pouokam, Guy Bertrand; Ajaezi, Godwin Chukwuebuka; Mantovani, Alberto; Orisakwe, Orish Ebere; Frazzoli, Chiara

2014-05-15

The plasticizer Bisphenol A (BPA) is banned in baby bottles in many industrialized countries due to safety concerns. We provide a pilot view on the potential BPA exposure of bottle-fed children in sub-Saharan Africa through an enquiry on availability, accessibility and affordability of plastic baby bottles, usage pattern, and risk perception. An observational survey was conducted in a randomized group of vending sites (34 pharmacies; 87 shops and markets), in three cities (Yaoundé, Foumbot, Bafoussam) in Cameroon (two regions), and in two cities (Lagos, Port Harcourt) in Nigeria (two states). Interviews in vending sites and group discussions were conducted with 248 mothers. Cameroon and Nigeria showed a largely comparable situation. Plastic baby bottles are largely imported from industrialized countries, where a label indicates the presence/absence of BPA. In pharmacies most plastic baby bottles are labeled as BPA-free, whereas most bottles sold in shops are not BPA-free. BPA-containing bottles are more accessible and affordable, due to sale in common shops and lower costs. The meaning of the label BPA-free is unknown to both vendors and customers: the BPA issue is also largely unknown to policy makers and media and no regulation exists on food contact materials. The wide availability of BPA-containing baby bottles, lack of information and usage patterns (e.g. temperature and duration of heating) suggest a likely widespread exposure of African infants. Possible usage recommendations to mitigate exposure are indicated. Risk communication to policy makers, sellers and citizens is paramount to raise awareness and to oppose possible dumping from countries where BPA-containing materials are banned. Our pilot study points out relevant global health issues such as the capacity building of African communities on informed choices and usage of baby products, and the exploitation of international knowledge by African scientists and risk managers. Copyright © 2014 Elsevier B.V. All rights reserved.

Efficacy and tolerability of bromelain in patients with chronic rhinosinusitis--a pilot study.

PubMed

Büttner, L; Achilles, N; Böhm, M; Shah-Hosseini, K; Mösges, R

2013-01-01

To evaluate the efficacy, tolerability, and impact on quality of life (QoL) of bromelain tablets (500 FIP) in patients with chronic rhinosinusitis (CRS). In this prospective, open-label observational pilot study, 12 patients suffering from CRS with (CRS+NP) or without (CRS-NP) nasal polyps who had undergone prior sinus surgery were treated with bromelain tablets (500 FIP) for three months. Efficacy was evaluated using symptom scores (Total Symptom Scores: TSS); a Total Rhinoscopy Score (TRS) was also determined. QoL was assessed by using the German, adapted version of the Sinonasal Outcome Test 20 (SNOT-20 GAV). Treatment with bromelain tablets (500 FIP) improved TSS, TRS and SNOT-20 GAV on average. This treatment was found to be more effective, however, for CRS-NP than for CRS+NP. The average intake was six tablets, equivalent to a daily dosage of 3000 FIP. No adverse events were observed. Preliminary results indicate good tolerability, symptom control, and improvement in QoL for the treatment of CRS using bromelain tablets (500 FIP).

CINRG pilot trial of coenzyme Q10 in steroid-treated Duchenne muscular dystrophy.

PubMed

Spurney, Christopher F; Rocha, Carolina Tesi; Henricson, Erik; Florence, Julaine; Mayhew, Jill; Gorni, Ksenija; Pasquali, Livia; Pestronk, Alan; Martin, Gerard R; Hu, Fengming; Nie, Lei; Connolly, Anne M; Escolar, Diana M

2011-08-01

Corticosteroid treatment slows disease progression and is the standard of care for Duchenne muscular dystrophy (DMD). Coenzyme Q10 (CoQ10) is a potent antioxidant that may improve function in dystrophin-deficient muscle. We performed an open-label, "add-on" pilot study of CoQ10 in thirteen 5-10-year-old DMD patients on steroids. The primary outcome measure was the total quantitative muscle testing (QMT) score. Twelve of 16 children (mean age 8.03 ± 1.64 years) completed the trial. Target serum levels of CoQ10 (≥2.5 μg/ml) were shown to be subject- and administration-dependent. Nine of 12 subjects showed an increase in total QMT score. Overall, CoQ10 treatment resulted in an 8.5% increase in muscle strength (P = 0.03). Addition of CoQ10 to prednisone therapy in DMD patients resulted in an increase in muscle strength. These results warrant a larger, controlled trial of CoQ10 in DMD. Copyright © 2011 Wiley Periodicals, Inc.

An open-label comparative pilot study of oral voriconazole and itraconazole for long-term treatment of paracoccidioidomycosis.

PubMed

Queiroz-Telles, Flavio; Goldani, Luciano Z; Schlamm, Haran T; Goodrich, James M; Espinel-Ingroff, Ana; Shikanai-Yasuda, Maria A

2007-12-01

In previous studies, itraconazole was revealed to be an effective therapy and was considered to be the gold standard treatment for mild-to-moderate acute and chronic clinical forms of paracoccidioidomycosis. A pilot study was conducted to investigate the efficacy, safety, and tolerability of voriconazole for the long-term treatment of acute or chronic paracoccidioidomycosis, with itraconazole as the control treatment. A randomized, open-label study was conducted at 3 Brazilian tertiary care hospitals. Patients were randomized (at a 2 : 1 ratio) to receive oral therapy with voriconazole or itraconazole for 6 months. Patients receiving >or=1 dose of study drug were evaluated for safety; patients with confirmed paracoccidioidomycosis who completed >or=6 months of therapy (treatment-evaluable patients) were evaluated for treatment efficacy. Satisfactory global response was assessed at the end of treatment. Fifty-three patients were evaluated for treatment safety (35 received voriconazole, and 18 received itraconazole). Both drugs were well tolerated. The most common treatment-related adverse events in the voriconazole group included abnormal vision, chromatopsia, rash, and headache; the most common treatment-related adverse events in the itraconazole group included bradycardia, diarrhea, and headache. Liver function test values were slightly higher in patients receiving voriconazole than in those receiving itraconazole; 2 patients in the voriconazole group were withdrawn from treatment because of increased liver function test values. In the intent-to-treat populations, the satisfactory response rate (i.e., complete or partial global response) was 88.6% among the voriconazole group and 94.4% among the itraconazole group. The response rate among treatment-evaluable patients was 100% for both treatment groups; no relapses were observed after 8 weeks of follow-up. This is, to our knowledge, the first study to demonstrate that voriconazole is as well tolerated and effective as itraconazole for the long-term treatment of paracoccidioidomycosis.

Physical micro-environment interventions for healthier eating in the workplace: protocol for a stepped wedge randomised controlled pilot trial.

PubMed

Vasiljevic, Milica; Cartwright, Emma; Pechey, Rachel; Hollands, Gareth J; Couturier, Dominique-Laurent; Jebb, Susan A; Marteau, Theresa M

2017-01-01

An estimated one third of energy is consumed in the workplace. The workplace is therefore an important context in which to reduce energy consumption to tackle the high rates of overweight and obesity in the general population. Altering environmental cues for food selection and consumption-physical micro-environment or 'choice architecture' interventions-has the potential to reduce energy intake. The first aim of this pilot trial is to estimate the potential impact upon energy purchased of three such environmental cues (size of portions, packages and tableware; availability of healthier vs. less healthy options; and energy labelling) in workplace cafeterias. A second aim of this pilot trial is to examine the feasibility of recruiting eligible worksites, and identify barriers to the feasibility and acceptability of implementing the interventions in preparation for a larger trial. Eighteen worksite cafeterias in England will be assigned to one of three intervention groups to assess the impact on energy purchased of altering (a) portion, package and tableware size ( n  = 6); (b) availability of healthier options ( n  = 6); and (c) energy (calorie) labelling ( n  = 6). Using a stepped wedge design, sites will implement allocated interventions at different time periods, as randomised. This pilot trial will examine the feasibility of recruiting eligible worksites, and the feasibility and acceptability of implementing the interventions in preparation for a larger trial. In addition, a series of linear mixed models will be used to estimate the impact of each intervention on total energy (calories) purchased per time frame of analysis (daily or weekly) controlling for the total sales/transactions adjusted for calendar time and with random effects for worksite. These analyses will allow an estimate of an effect size of each of the three proposed interventions, which will form the basis of the sample size calculations necessary for a larger trial. ISRCTN52923504.

Insulin Secretion Improves in Cystic Fibrosis Following Ivacaftor Correction of CFTR: A Small Pilot Study

PubMed Central

Bellin, Melena D.; Laguna, Theresa; Leschyshyn, Janice; Regelmann, Warren; Dunitz, Jordan; Billings, JoAnne; Moran, Antoinette

2013-01-01

Objective To determine whether the cystic fibrosis transmembrane conductance regulator (CFTR) is involved in human insulin secretion by assessing the metabolic impact of the new CFTR corrector, ivacaftor. Methods This open-label pilot study was conducted in CF patients with the G551D mutation given new prescriptions for ivacaftor. At baseline and 4 weeks after daily ivacaftor therapy, intravenous (IVGTT) and oral glucose (OGTT) tolerance tests were performed. Results Five patients age 6–52 were studied. After 1 month on ivacaftor, the insulin response to oral glucose improved by 66–178% in all subjects except one with long-standing diabetes. OGTT glucose levels were not lower in the two individuals with diabetes or the two with normal glucose tolerance (NGT), but the glucose tolerance category in the subject with impaired glucose tolerance (IGT) improved to NGT after treatment. In response to intravenous glucose, the only patient whose acute insulin secretion did not improve had newly diagnosed, untreated CFRD. The others improved by 51–346%. Acute insulin secretion was partially restored in two subjects with no measurable acute insulin response at baseline, including the one with IGT and the one with long-standing diabetes. Conclusions This small pilot study suggests there is a direct role of CFTR in human insulin secretion. Larger, long-term longitudinal studies are necessary to determine whether early initiation of CFTR correction, particularly in young children with CF who have not yet lost considerable beta-cell mass, will delay or prevent development of diabetes in this high risk population. PMID:23952705

ClereMed: Lessons Learned From a Pilot Study of a Mobile Screening Tool to Identify and Support Adults Who Have Difficulty With Medication Labels

PubMed Central

Gates, Allison; Dolovich, Lisa; Slavcev, Roderick; Drimmie, Rob; Aghaei, Behzad; Poon, Calvin; Khan, Shamrozé; Leat, Susan J

2014-01-01

Background In order to take medications safely and effectively, individuals need to be able to see, read, and understand the medication labels. However, one-half of medication labels are currently misunderstood, often because of low literacy, low vision, and cognitive impairment. We sought to design a mobile tool termed ClereMed that could rapidly screen for adults who have difficulty reading or understanding their medication labels. Objective The aim of this study was to build the ClereMed prototype; to determine the usability of the prototype with adults 55 and over; to assess its accuracy for identifying adults with low-functional reading ability, poor ability on a real-life pill-sorting task, and low cognition; and to assess the acceptability of a touchscreen device with older adults with age-related changes to vision and cognition. Methods This pilot study enrolled adults (≥55 years) who were recruited through pharmacies, retirement residences, and a low-vision optometry clinic. ClereMed is a hypertext markup language (HTML)-5 prototype app that simulates medication taking using an iPad, and also provides information on how to improve the accessibility of prescription labels. A paper-based questionnaire included questions on participant demographics, computer literacy, and the Systems Usability Scale (SUS). Cognition was assessed using the Montreal Cognitive Assessment tool, and functional reading ability was measured using the MNRead Acuity Chart. Simulation results were compared with a real-life, medication-taking exercise using prescription vials, tablets, and pillboxes. Results The 47 participants had a mean age of 76 (SD 11) years and 60% (28/47) were female. Of the participants, 32% (15/47) did not own a computer or touchscreen device. The mean SUS score was 76/100. ClereMed correctly identified 72% (5/7) of participants with functional reading difficulty, and 63% (5/8) who failed a real-life pill-sorting task, but only 21% (6/28) of participants with cognitive impairment. Participants who owned a computer or touchscreen completed ClereMed in a mean time of 26 (SD 16) seconds, compared with 52 (SD 34) seconds for those who do not own a device (P<.001). Those who had difficulty, struggled with screen glare, button activation, and the “drag and drop” function. Conclusions ClereMed was well accepted by older participants, but it was only moderately accurate for reading ability and not for mild cognitive impairment. Future versions may be most useful as part of a larger medication assessment or as a tool to help family members and caregivers identify individuals with impaired functional reading ability. Future research is needed to improve the sensitivity for measuring cognitive impairment and on the feasibility of implementing a mobile app into pharmacy workflow. PMID:25131813

Insidious Harm of Medication Diluents as a Contributor to Cumulative Volume and Hyperchloremia: A Prospective, Open-Label, Sequential Period Pilot Study.

PubMed

Magee, Carolyn A; Bastin, Melissa L Thompson; Laine, Melanie E; Bissell, Brittany D; Howington, Gavin T; Moran, Peter R; McCleary, Emily J; Owen, Gary D; Kane, Lauren E; Higdon, Emily A; Pierce, Cathy A; Morris, Peter E; Flannery, Alexander H

2018-05-04

Although the potential dangers of hyperchloremia from resuscitation fluids continue to emerge, no study to date has considered the contribution of medication diluents to cumulative volume and hyperchloremia. This study compares saline versus dextrose 5% in water as the primary medication diluent and the occurrence of hyperchloremia in critically ill patients. Prospective, open-label, sequential period pilot study. Medical ICU of a large academic medical center. Adult patients admitted to the medical ICU were eligible for inclusion. Patients who were admitted for less than 48 hours, less than 18 years old, pregnant, incarcerated, or who had brain injury were excluded. Saline as the primary medication diluent for 2 months followed by dextrose 5% in water as the primary medication diluent for 2 months. A total of 426 patients were included, 216 in the saline group and 210 in the dextrose 5% in water group. Medication diluents accounted for 63% of the total IV volume over the observation period. In the saline group, 17.9% developed hyperchloremia compared with 10.5% in the dextrose 5% in water group (p = 0.037), which was statistically significant in multivariable analysis (odds ratio, 0.50; 95% CI, 0.26-0.94; p = 0.031). In the saline group, 34.2% developed acute kidney injury versus 24.5% in the dextrose 5% in water group (p = 0.035); however, this was not statistically significant when adjusting for baseline covariates. No other significant differences in dysnatremias, insulin requirements, glucose control, ICU length of stay, or ICU mortality were observed. This study identified that medication diluents contribute substantially to the total IV volume received by critically ill patients. Saline as the primary medication diluent compared with dextrose 5% in water is associated with hyperchloremia, a possible risk factor for acute kidney injury.

A pilot, open-label, 8-week study evaluating the efficacy, safety and tolerability of adjunctive minocycline for the treatment of bipolar I/II depression.

PubMed

Soczynska, Joanna K; Kennedy, Sidney H; Alsuwaidan, Mohammad; Mansur, Rodrigo B; Li, Madeline; McAndrews, Mary Pat; Brietzke, Elisa; Woldeyohannes, Hanna O; Taylor, Valerie H; McIntyre, Roger S

2017-05-01

The objectives of the study were to determine if adjunctive minocycline mitigates depressive symptom severity and improves cognitive function in individuals with bipolar I/II disorder (BD). The study also aimed to determine if changes in depressive and/or cognitive symptoms over the course of treatment were associated with changes in circulating inflammatory cytokine levels. A total of 29 (intention-to-treat: n=27) adults meeting DSM-IV-TR criteria for a major depressive episode as part of bipolar I or II disorder (i.e. Hamilton Depression Rating Scale 17-item [HAMD-17] ≥20) were enrolled in an 8-week, open-label study with adjunctive minocycline (100 mg bid). The primary outcome measure was the Montgomery-Åsberg Depression Rating Scale (MADRS). The HAMD-17, Clinical Global Impression-Severity (CGI-S), cognitive test composite scores and plasma cytokines were secondary outcome measures. Plasma cytokines were measured with the 30 V-Plex Immunoassay from Meso Scale Discovery. Adjunctive minocycline was associated with a reduction in depressive symptom severity from baseline to week 8 on the MADRS (P<.001, d=0.835), HAMD-17 (P<.001, d=0.949) and CGI-S (P<.001, d=1.09). Improvement in psychomotor speed, but not verbal memory or executive function, was observed only amongst individuals exhibiting a reduction in depression severity (P=.007, d=0.826). Levels of interleukin (IL)-12/23p40 (P=.002) were increased, while levels of IL-12p70 (P=.001) and C-C motif chemokine ligand 26 (CCL26) (P<.001) were reduced from baseline to week 8. A reduction in CCL26 levels was associated with a less favourable treatment response (P<.001). Results from the pilot study suggest that adjunctive minocycline may exert antidepressant effects in individuals with bipolar depression, possibly by targeting inflammatory cytokines. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

¹¹¹Indium-labeled ultrafine carbon particles; a novel aerosol for pulmonary deposition and retention studies.

PubMed

Sanchez-Crespo, Alejandro; Klepczynska-Nyström, Anna; Lundin, Anders; Larsson, Britt Marie; Svartengren, Magnus

2011-02-01

Continuous environmental or occupational exposure to airborne particulate pollution is believed to be a major hazard for human health. A technique to characterize their deposition and clearance from the lungs is fundamental to understand the underlying mechanisms behind their negative health effects. In this work, we describe a method for production and follow up of ultrafine carbon particles labeled with radioactive ¹¹¹Indium (¹¹¹In). The physicochemical and biological properties of the aerosol are described in terms of particle size and concentration, agglomeration rate, chemical bonding stability, and human lung deposition and retention. Preliminary in vivo data from a healthy human pilot exposure and 1-week follow up of the aerosol is presented. More than 98% of the generated aerosol was labeled with Indium and with particle sizes log normally distributed around 79  nm count median diameter. The aerosol showed good generation reproducibility and chemical stability, about 5% leaching 7 days after generation. During human inhalation, the particles were deposited in the alveolar space, with no central airways involvement. Seven days after exposure, the cumulative activity retention was 95.3%. Activity leaching tests from blood and urine samples confirmed that the observed clearance was explained by unbound activity, suggesting that there was no significant elimination of ultrafine particles. Compared to previously presented methods based on Technegas, ¹¹¹In-labelled ultrafine carbon particles allow for extended follow-up assessments of particulate pollution retention in healthy and diseased lungs.

STS-5 crewmembers with meal tray assembly on middeck

NASA Technical Reports Server (NTRS)

1982-01-01

Commander Brand (in dark blue shirt), Pilot Overmyer (left), and Mission Specialist (MS) Lenoir (right) conduct microgravity experiments with food containers and meal tray assemblies in front of middeck port side wall and side hatch. Brand prepares to eat as meal tray assembly floats above his chest and Overmeyer and Lenoir look on. Sign on port side wall is labeled STS-5 Message Board.

Aerosol studies with Listeria innocua and Listeria monocytogenes.

PubMed

Zhang, Guodong; Ma, Li; Oyarzabal, Omar A; Doyle, Michael P

2007-08-01

Aerosol studies of Listeria monocytogenes in food processing plants have been limited by lack of a suitable surrogate microorganism. The objective of this study was to investigate the potential of using green fluorescent protein-labeled strains of Listeria innocua as a surrogate for L. monocytogenes for aerosol studies. These studies were conducted in a laboratory bioaerosol chamber and a pilot food-processing facility. Four strains of L. innocua and five strains of L. monocytogenes were used. In the laboratory chamber study, Listeria cells were released into the environment at two different cell numbers and under two airflow conditions. Trypticase soy agar (TSA) plates and oven-roasted breasts of chicken and turkey were placed in the chamber to monitor Listeria cell numbers deposited from aerosols. A similar experimental design was used in the pilot plant study; however, only L. innocua was used. Results showed that L. monocytogenes and L. innocua survived equally well on chicken and turkey breast meats and TSA plates. No-fan and continuous fan applications, which affected airflow, had no significant effect on settling rates of aerosolized L. monocytogenes and L. innocua in the bioaerosol chamber or L. innocua in the pilot plant study. Listeriae cell numbers in the air decreased rapidly during the first 1.5 h following release, with few to no listeriae detected in the air at 3 h. Aerosol particles with diameters of 1 and 2 microM correlated directly with the number of Listeria cells in the aerosol but not with particles that were 0.3, 0.5, and 5 microM in diameter. Results indicate that L. innocua can be used as a surrogate for L. monocytogenes in an aerosol study.

Intermittent granulocyte and monocyte apheresis versus mercaptopurine for maintaining remission of ulcerative colitis: a pilot study.

PubMed

Sakuraba, Atsushi; Sato, Toshiro; Morohoshi, Yuichi; Matsuoka, Katsuyoshi; Okamoto, Susumu; Inoue, Nagamu; Takaishi, Hiromasa; Ogata, Haruhiko; Iwao, Yasushi; Hibi, Toshifumi

2012-06-01

The effect of granulocyte and monocyte adsorption apheresis (GMA) on prevention of relapse of ulcerative colitis (UC) is not clear. This was a pilot open-labeled, prospective, randomized, unblinded study to compare the tolerability and efficacy of intermittent GMA (once every 2 weeks) with mercaptopurine to maintain remission of UC. Twenty-one patients with UC, who had achieved remission by induction therapies were randomly assigned to receive either intermittent GMA (N = 10) or oral mercaptopurine (0.5 mg/kg per day; N = 11). The study period was 24 months. The rate of the patients maintaining remission and the incidences of adverse effects were compared between the two groups. At 24 months, seven of 10 patients (70.0%) on intermittent GMA and seven of 11 patients (63.6%, P = 1.00) on oral mercaptopurine were still in remission. Three patients relapsed in each group. One patient taking mercaptopurine, but none receiving intermittent GMA, dropped out because of adverse effects. Intermittent therapy with GMA was well tolerated and a substantial proportion of patients maintained remission. Intermittent GMA therapy in maintaining remission of UC merits further investigation. © 2012 The Authors. Therapeutic Apheresis and Dialysis © 2012 International Society for Apheresis.

Singing in groups for Parkinson's disease (SING-PD): a pilot study of group singing therapy for PD-related voice/speech disorders.

PubMed

Shih, Ludy C; Piel, Jordan; Warren, Amanda; Kraics, Lauren; Silver, Althea; Vanderhorst, Veronique; Simon, David K; Tarsy, Daniel

2012-06-01

Parkinson's disease related speech and voice impairment have significant impact on quality of life measures. LSVT(®)LOUD voice and speech therapy (Lee Silverman Voice Therapy) has demonstrated scientific efficacy and clinical effectiveness, but musically based voice and speech therapy has been underexplored as a potentially useful method of rehabilitation. We undertook a pilot, open-label study of a group-based singing intervention, consisting of twelve 90-min weekly sessions led by a voice and speech therapist/singing instructor. The primary outcome measure of vocal loudness as measured by sound pressure level (SPL) at 50 cm during connected speech was not significantly different one week after the intervention or at 13 weeks after the intervention. A number of secondary measures reflecting pitch range, phonation time and maximum loudness also were unchanged. Voice related quality of life (VRQOL) and voice handicap index (VHI) also were unchanged. This study suggests that a group singing therapy intervention at this intensity and frequency does not result in significant improvement in objective and subject-rated measures of voice and speech impairment. Copyright © 2012 Elsevier Ltd. All rights reserved.

Modafinil treatment for fatigue in HIV+ patients: a pilot study.

PubMed

Rabkin, Judith G; McElhiney, Martin C; Rabkin, Richard; Ferrando, Stephen J

2004-12-01

Fatigue is widespread among human immunodeficiency virus-positive (HIV+) patients, yet few studies have assessed effective treatments. The authors conducted a pilot study to evaluate the efficacy of modafinil for fatigue in this clinical population. Response was evaluated after a 4-week open-label trial. Data were collected from February 2003 through January 2004. Responders were offered 8 additional weeks of modafinil. Inclusion criteria included written approval from the primary care physician, clinically significant fatigue, current use of anti-retroviral medications, and the absence of treatable medical conditions known to cause fatigue. Exclusion criteria included untreated major depression and current substance abuse. Major outcome measures were the Fatigue Severity Scale, Chalder Fatigue Scale, Hamilton Rating Scale for Depression, Beck Depression Inventory, and neuropsychological tests assessing verbal memory, speed of processing, and executive function. Immunologic and virologic measures were performed at baseline and week 4 to assess safety of treatment. All 30 patients who enrolled completed 4 weeks of treatment; 24 (80%) were rated as responders. Responders showed statistically significant improvement on all measures of fatigue, depressive symptoms, and executive function, while nonresponders did not. Mean values of CD4 cell count and HIV RNA viral load did not change. The most common side effect was headache, followed by irritability and feeling "hyper." This pilot study shows encouraging results for modafinil in alleviation of fatigue in HIV+ patients. In addition, depressive symptoms were substantially reduced. Improvements on measures of verbal memory and executive function were significant, but in the absence of a placebo control, the magnitude of effect due to practice cannot be determined.

Combined Transcranial Direct Current Stimulation and Vision Restoration Training in Subacute Stroke Rehabilitation: A Pilot Study.

PubMed

Alber, Raimund; Moser, Hermann; Gall, Carolin; Sabel, Bernhard A

2017-08-01

Visual field defects after posterior cerebral artery stroke can be improved by vision restoration training (VRT), but when combined with transcranial direct current stimulation (tDCS), which alters brain excitability, vision recovery can be potentiated in the chronic stage. To date, the combination of VRT and tDCS has not been evaluated in postacute stroke rehabilitation. To determine whether combined tDCS and VRT can be effectively implemented in the early recovery phase following stroke, and to explore the feasibility, safety and efficacy of an early intervention. Open-label pilot study including a case series of 7 tDCS/VRT versus a convenience sample of 7 control patients (ClinicalTrials.gov ID: NCT02935413). Rehabilitation center. Patients with homonymous visual field defects following a posterior cerebral artery stroke. Seven homonymous hemianopia patients were prospectively treated with 10 sessions of combined tDCS (2.mA, 10 daily sessions of 20 minutes) and VRT at 66 (±50) days on average poststroke. Visual field recovery was compared with the retrospective data of 7 controls, whose defect sizes and age of lesions were matched to those of the experimental subjects and who had received standard rehabilitation with compensatory eye movement and exploration training. All 7 patients in the treatment group completed the treatment protocol. The safety and acceptance were excellent, and patients reported occasional skin itching beneath the electrodes as the only minor side effect. Irrespective of their treatment, both groups (treatment and control) showed improved visual fields as documented by an increased mean sensitivity threshold in decibels in standard static perimetry. Recovery was significantly greater (P < .05) in the tDCS/VRT patients (36.73% ± 37.0%) than in the controls (10.74% ± 8.86%). In this open-label pilot study, tDCS/VRT in subacute stroke was demonstrated to be safe, with excellent applicability and acceptance of the treatment. Preliminary effectiveness calculations show that tDCS/VRT may be superior to standard vision training procedures. A confirmatory, larger-sample, controlled, randomized, and double-blind trial is now underway to compare real-tDCS- versus sham-tDCS-supported visual field training in the early vision rehabilitation phase. IV. Copyright © 2017 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.

Head-to-Head Comparison of Aripiprazole and Risperidone in the Treatment of ADHD Symptoms in Children with Autistic Spectrum Disorder and ADHD: A Pilot, Open-Label, Randomized Controlled Study.

PubMed

Lamberti, Marco; Siracusano, Rosamaria; Italiano, Domenico; Alosi, Norma; Cucinotta, Francesca; Di Rosa, Gabriella; Germanò, Eva; Spina, Edoardo; Gagliano, Antonella

2016-08-01

Autism spectrum disorder (ASD) and attention-deficit/hyperactivity disorder (ADHD) are frequently overlapping neurodevelopmental disorders. Individuals in whom the disorders are comorbid show more severe impairment because of deficits in the processing of social situations, adaptive functioning, and executive control than individuals with either disorder alone. This open-label pilot study aimed to evaluate and compare the efficacy and tolerability of risperidone and aripiprazole for treating ADHD symptoms in patients with both ASD and ADHD over the course of 24 weeks of treatment. Patients (n = 44) were randomly assigned to start treatment with risperidone (22 patients) or aripiprazole (22 patients). Children were evaluated before starting treatment (T0), and after 12 weeks (T1) and 24 weeks (T2) of treatment. At each visit, specific psychiatric clinical scales were administered to assess the efficacy of the two drugs. The mean age was 8.4 ± 2.9 years in the aripiprazole group and 7.8 ± 2.3 years in the risperidone group. A total of 37 children (29 boys and 8 girls) completed the study (18 in the aripiprazole group and 19 in the risperidone group). Aripiprazole and risperidone appeared to have similar benefits in terms of efficacy and tolerability, although there were slight differences between the two drugs. Both groups showed a significant improvement in ADHD symptoms after 24 weeks of treatment (ADHD Rating Scale, Conners Parent Rating Scale-Hyperactivity, and Clinical Global Improvement-Severity Scale). No significant difference between the two drugs on any parameters at 24 weeks were found. Prolactin levels were decreased in the aripiprazole group. Both drugs were well tolerated, with no serious adverse events detected. Our study confirms the efficacy of both aripiprazole and risperidone in ameliorating ADHD symptoms of children also presenting with ASD.

Brief report: effect of ambrisentan treatment on exercise-induced pulmonary hypertension in systemic sclerosis: a prospective single-center, open-label pilot study.

PubMed

Saggar, Rajeev; Khanna, D; Shapiro, S; Furst, D E; Maranian, P; Clements, P; Abtin, F; Dua, Shiv; Belperio, J; Saggar, Rajan

2012-12-01

Exercise-induced pulmonary hypertension (ePH) may represent an early, clinically relevant phase in the spectrum of pulmonary vascular disease. The purpose of this pilot study was to describe the changes in hemodynamics and exercise capacity in patients with systemic sclerosis (SSc) spectrum-associated ePH treated with open-label daily ambrisentan. Patients were treated with ambrisentan, 5 mg or 10 mg once daily, for 24 weeks. At baseline and 24 weeks, patients with SSc spectrum disorders exercised in a supine position, on a lower extremity cycle ergometer. All patients had normal hemodynamics at rest. We defined baseline ePH as a mean pulmonary artery pressure of >30 mm Hg with maximum exercise and a transpulmonary gradient (TPG) of >15 mm Hg. The primary end point was change in pulmonary vascular resistance (PVR) with exercise. Secondary end points included an improvement from baseline in 6-minute walking distance, health-related quality of life assessments, and cardiopulmonary hemodynamics. Of the 12 enrolled patients, 11 completed the study. At 24 weeks there were improvements in mean exercise PVR (85.8 dynes × second/cm(5) ; P = 0.003) and mean distance covered during 6-minute walk (44.5 meters; P = 0.0007). Improvements were also observed in mean exercise cardiac output (1.4 liters/minute; P = 0.006), mean pulmonary artery pressure (-4.1 mm Hg; P = 0.02), and total pulmonary resistance (-93.0 dynes × seconds/cm(5) ; P = 0.0008). Three patients developed resting pulmonary arterial hypertension during the 24 weeks. Exercise hemodynamics and exercise capacity in patients with SSc spectrum-associated ePH improved over 24 weeks with exposure to ambrisentan. Placebo-controlled studies are needed to confirm whether this is a drug-related effect and to determine optimal therapeutic regimens for patients with ePH. Copyright © 2012 by the American College of Rheumatology.

Post-acute crisis text messaging outreach for suicide prevention: a pilot study.

PubMed

Berrouiguet, Sofian; Gravey, Michel; Le Galudec, Mickaël; Alavi, Zarrin; Walter, Michel

2014-07-30

Several post-suicide prevention strategies such as sending postcards or making phone calls have been used to keep in contact with suicide attempters. The continuity of care has been beneficial to the prevention of post-acute suicidal behaviors. The aim of the study was to evaluate the technical feasibility and acceptability of text messaging outreach in post-acute suicide attempters. Eighteen post-suicidal patients were included in a prospective, monocentric, open-label, 2 months pilot study. The text messages were sent from the intranet program that we specially developed for the study. Technical feasibility of this text message intervention was evaluated by the analysis of text message reports. Acceptability of such intervention was evaluated by a standardized phone interview. Our study showed that receiving text messages sent from an intranet program after a suicide attempt is technically possible. This post-crisis outreach program was accepted by the patients who found it to have a positive preventive impact. Text messaging outreach offers several advantages such as lower cost, and easier utilization compared to current post-acute care strategies. We suggest further randomized controlled trials in a large sample of suicidal patients to assess the efficacy of this novel outreach tool for prevention of post-acute suicide. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Prospective data mining of six products in the US FDA Adverse Event Reporting System: disposition of events identified and impact on product safety profiles.

PubMed

Bailey, Steven; Singh, Ajay; Azadian, Robert; Huber, Peter; Blum, Michael

2010-02-01

The use of data mining has increased among regulators and pharmaceutical companies. The incremental value of data mining as an adjunct to traditional pharmacovigilance methods has yet to be demonstrated. Specifically, the utility in identifying new safety signals and the resources required to do so have not been elucidated. To analyse the number and types of disproportionately reported product-event combinations (DRPECs), as well as the final disposition of each, in order to understand the potential utility and resource implications of routinely conducting data mining in the US FDA Adverse Event Reporting System (AERS). We generated DRPECs from AERS for six of Wyeth's products, prospectively tracked their dispositions and evaluated the appropriate DRPECs in the company's safety database. We chose EB05 (the lower bound of the 90% confidence interval around the Empirical Bayes Geometric Mean) > or =2 as the appropriate metric, employing stratification based on age, sex and year of report. A total of 861 DRPECs were identified - the average number of DRPECs was 144 per product. The proportion of unique preferred terms (PTs) in AERS for each drug with an EB05 > or =2 was similar across the six products (5.1-8.5%). Overall, 64.0% (551) of the DRPECs were closed after the initial screening (44.8% labelled, 14.3% indication related, 4.9% non-interpretable). An additional 9.9% (85) had been reviewed within the prior year and were not further reviewed. The remaining 26.1% (225) required full case review. After review of all pertinent reports and additional data, it was determined which of the DRPECs necessitated a formal review by the company's ongoing Safety Review Team (SRT) process. In total, 3.6% (31/861) of the DRPECs, yielding 16 medical concepts, were reviewed by the SRT, leading to seven labelling changes. These labelling changes involved 1.9% of all DRPECs generated. Four of the six compounds reviewed as part of this pilot had an identified labelling change. The workload required for this pilot, which was driven primarily by those DRPECs requiring review, was extensive, averaging 184 hours per product. The number of DRPECs identified for each drug approximately correlated with the number of unique PTs in the database. Over one-half of DRPECs were either labelled as per the company's reference safety information (RSI) or were under review after identification by traditional pharmacovigilance activities, suggesting that for marketed products these methods do identify adverse events detected by traditional pharmacovigilance methods. Approximately three-quarters of the 861 DRPECs identified were closed without case review after triage. Of the approximately one-quarter of DRPECs that required formal case review, seven resulted in an addition to the RSI for the relevant products. While this pilot does not allow us to comment on the utility of routine data mining for all products, it is significant that several new safety concepts were identified through this prospective exercise.

Pharmacokinetic analysis of 14C-ursodiol in newborn infants using accelerator mass spectrometry.

PubMed

Gordi, Toufigh; Baillie, Rebecca; Vuong, Le T; Abidi, Saira; Dueker, Stephen; Vasquez, Herbert; Pegis, Priscilla; Hopper, Andrew O; Power, Gordon G; Blood, Arlin B

2014-09-01

Pharmacokinetic studies in the neonatal population are often limited by the small volume of blood that can be collected. The high sensitivity of (14) C-accelerator mass spectrometry (AMS) enables pharmacokinetic studies to be conducted with greatly reduced sample volumes. We demonstrated the utility of AMS in infants by studying the plasma pharmacokinetic behavior of nanogram doses of (14) C-ursodiol administered as a non-perturbing microdose or as a microtracer with therapeutic doses of non-labeled ursodiol in infants. Five non-cholestatic infants were administered 3 consecutive oral microdoses of (14) C-ursodiol: 8 ng (1.0 nCi), 26 ng (3.3 nCi), and 80 ng (10 nCi) 48 hours apart. Three additional infants with cholestasis were administered a single 80 ng (10.0 nCi) oral dose of (14) C-ursodiol together with a therapeutic dose of 40 mg/kg of non-labeled ursodiol. A pharmacokinetic model describing ursodiol concentrations was developed using nonlinear mixed-effects modeling. The pharmacokinetics of ursodiol in this pilot study were best described by a two-compartment model with first-order elimination. This study demonstrates the feasibility and utility of microdose and microtrace methodology in pediatric research. © 2014, The American College of Clinical Pharmacology.

Dextromethorphan/Quinidine in Migraine Prophylaxis: An Open-label Observational Clinical Study.

PubMed

Berkovich, Regina R; Sokolov, Alexey Y; Togasaki, Daniel M; Yakupova, Aida A; Cesar, Paul-Henry; Sahai-Srivastava, Soma

This study aimed to assess potential efficacy and safety of dextromethorphan/quinidine (DMQ) in prophylactic treatment of migraine in patients with multiple sclerosis (MS) with superimposed pseudobulbar affect (PBA). Multiple sclerosis patients with superimposed PBA and comorbid migraine were enrolled into this open-label observational study at the University of Southern California Comprehensive MS Center. The baseline characteristics included, among other data, frequency and severity of acute migraine attacks and use of migraine relievers. The DMQ was used exclusively per its primary indication - PBA symptoms control - 20/10 mg orally, twice a day for the mean of 4.5 months (the shortest exposure registered was 3 months and the longest, 6 months). To determine whether treatment caused an effect on migraine frequency and severity, the baseline and posttreatment values were compared using nonparametric sign test. Thirty-three MS subjects with PBA, who also suffered from migraines, were identified. Twenty-nine subjects had improvement in headache frequency, 4 had no change, and none had worsening (P < 0.001 as compared with the baseline). Twenty-eight subjects had improvement in headache severity, 5 had no change, and none had worsening (P < 0.001). Our pilot study results provide evidence that DMQ shows promise as a candidate for larger clinical studies evaluating its efficacy for the prevention of migraine headaches.

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.

A Two-Phase Pilot Study to Evaluate the Safety and Tolerability of an In Situ Polymerizing Collagen.

PubMed

Inglefield, Christopher; Rone-McCrate, Rebecca; Brooks, Robert; Zhu, Jiaxun; Grant, Sheila; DeVore, Dale P

2017-09-01

Demand for collagen-based fillers has declined primarily because of limited long-term clinical benefit and the introduction of hyaluronic acid compositions. In situ polymerizing collagen is a noncrosslinked solution of porcine collagen containing a collagenase shield that undergoes fibrillogenesis on injected into tissues forming a natural matrix. Conduct a prospective, single-center, dual-phase open-label study in 8 subjects to evaluate the safety, tolerability, and efficacy of the porcine collagen composition. In Phase I, potential hypersensitivity of the collagen composition was evaluated after skin testing in the back (men) or forearms of subjects (women). In Phase II, subjects showing no signs of hypersensitivity received collagen injections into the nasolabial area followed by evaluation at 1, 4, 8, and 12 weeks using the Global Aesthetic Improvement Scale. None of the subjects had signs of hypersensitivity and all continued in Phase II. The treating physician(s) reported no post-treatment adverse events. Improvement of the nasolabial fold was observed by the physicians and confirmed by assessment of high-resolution photographs and Global Aesthetic Improvement Scale scores over the 12-week treatment were maintained. In this pilot clinical study in situ polymerizing collagen was shown to be safe and effective throughout the 3-month study period.

Metabolic impact of switching antipsychotic therapy to aripiprazole after weight gain: a pilot study.

PubMed

Kim, Sun H; Ivanova, Oxana; Abbasi, Fahim A; Lamendola, Cindy A; Reaven, Gerald M; Glick, Ira D

2007-08-01

Switching antipsychotic regimen to agents with low weight gain potential has been suggested in patients who gain excessive weight on their antipsychotic therapy. In an open-label pilot study, we evaluated the metabolic and psychiatric efficacy of switching to aripiprazole in 15 (9 men, 6 women) outpatients with schizophrenia who had gained at least 10 kg on their previous antipsychotic regimen. Individuals had evaluation of glucose tolerance, insulin resistance (insulin suppression test), lipid concentrations, and psychiatric status before and after switching to aripiprazole for 4 months. A third of the individuals could not psychiatrically tolerate switching to aripiprazole. In the remaining individuals, psychiatric symptoms significantly improved with decline in Clinical Global Impression Scale (by 26%, P = 0.015) and Positive and Negative Syndrome Scale (by 22%, P = 0.023). Switching to aripiprazole did not alter weight or metabolic outcomes (fasting glucose, insulin resistance, and lipid concentrations) in the patients of whom 73% were insulin resistant and 47% had impaired or diabetic glucose tolerance at baseline. In conclusion, switching to aripiprazole alone does not ameliorate the highly prevalent metabolic abnormalities in the schizophrenia population who have gained weight on other second generation antipsychotic medications.

Mindfulness for adolescent chronic pain: a pilot feasibility study.

PubMed

Lovas, David Adam; Pajer, Kathleen; Chorney, Jill MacLaren; Vo, Dzung X; Howlett, Melissa; Doyle, Ashley; Huber, Adam

2017-09-01

Chronic pain is common in paediatric populations and many patients do not respond to the currently available evidence-based treatments. Mindfulness-based interventions (MBIs) have a growing evidence-base in adults, but evidence is limited in youth with chronic pain. We conducted an open-label pilot study to test the feasibility of an 8-week MBI for this population. Seven adolescents (age range 14-17; median age 15; six female) completed the intervention. There were no dropouts. Median class attendance was seven of eight total sessions (SD = 0.76). Only one (14.3%) participant reported not finding it useful; five (71.4%) reported that they would recommend it to a friend; and the remaining two (28.6%) reported "maybe". There was no worsening of internalizing symptoms. Secondary outcomes included significant reduction of pain intensity, which was maintained at three-month follow-up. Somatic symptoms and functional disability were both non-significantly lower immediately following the intervention; but were significantly improved at three-month follow-up. An eight-week group MBI is a feasible intervention for adolescents with chronic pain, and warrants further investigation as a potential alternative to cognitive behavioural therapy in this population.

Label free cell tracking in 3D tissue engineering constructs with high resolution imaging

NASA Astrophysics Data System (ADS)

Smith, W. A.; Lam, K.-P.; Dempsey, K. P.; Mazzocchi-Jones, D.; Richardson, J. B.; Yang, Y.

2014-02-01

Within the field of tissue engineering there is an emphasis on studying 3-D live tissue structures. Consequently, to investigate and identify cellular activities and phenotypes in a 3-D environment for all in vitro experiments, including shape, migration/proliferation and axon projection, it is necessary to adopt an optical imaging system that enables monitoring 3-D cellular activities and morphology through the thickness of the construct for an extended culture period without cell labeling. This paper describes a new 3-D tracking algorithm developed for Cell-IQ®, an automated cell imaging platform, which has been equipped with an environmental chamber optimized to enable capturing time-lapse sequences of live cell images over a long-term period without cell labeling. As an integral part of the algorithm, a novel auto-focusing procedure was developed for phase contrast microscopy equipped with 20x and 40x objectives, to provide a more accurate estimation of cell growth/trajectories by allowing 3-D voxels to be computed at high spatiotemporal resolution and cell density. A pilot study was carried out in a phantom system consisting of horizontally aligned nanofiber layers (with precise spacing between them), to mimic features well exemplified in cellular activities of neuronal growth in a 3-D environment. This was followed by detailed investigations concerning axonal projections and dendritic circuitry formation in a 3-D tissue engineering construct. Preliminary work on primary animal neuronal cells in response to chemoattractant and topographic cue within the scaffolds has produced encouraging results.

A Pilot Stability Study of Dehydroepiandrosterone Rapid-dissolving Tablets Prepared by Extemporaneous Compounding.

PubMed

Rush, Steven D; Vernak, Charlene; Zhao, Fang

2017-01-01

Dehydroepiandrosterone supplementation is used to treat a variety of conditions. Rapid-dissolving tablets are a relatively novel choice for compounded dehydroepiandrosterone dosage forms. While rapid-dissolving tablets offer ease of administration, there are uncertainties about the physical and chemical stability of the drug and dosage form during preparation and over long-term storage. This study was designed to evaluate the stability of dehydroepiandrosterone rapid-dissolving tablets just after preparation and over six months of storage. The Professional Compounding Centers of America rapid-dissolving tablet mold and base formula were used to prepare 10-mg strength dehydroepiandrosterone rapid-dissolving tablets. The formulation was heated at 100°C to 110°C for 30 minutes, released from the mold, and cooled at room temperature for 30 minutes. The resulting rapid-dissolving tablets were individually packaged in amber blister packs and stored in a stability chamber maintained at 25°C and 60% relative humidity. The stability samples were pulled at pre-determined time points for evaluation, which included visual inspection, tablet weight check, United States Pharmacopeia disintegration test, and stability-indicating high-performance liquid chromatography. The freshly prepared dehydroepiandrosterone rapiddissolving tablets exhibited satisfactory chemical and physical stability. Time 0 samples disintegrated within 40 seconds in water kept at 37°C. The high-performance liquid chromatographic results confirmed that the initial potency was 101.9% of label claim and that there was no chemical degradation from the heating procedure. Over six months of storage, there were no significant changes in visual appearance, physical integrity, or disintegration time for any of the stability samples. The high-performance liquid chromatographic results also indicated that dehydroepiandrosterone rapid-dissolving tablets retained >95% label claim with no detectable degradation products. The dehydroepiandrosterone rapid-dissolving tablets investigated in this pilot study were physically and chemically stable during preparation and over six months of storage at 25°C and 60% relative humidity. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

Exposure to Theory-Driven Text Messages is Associated with HIV Risk Reduction Among Methamphetamine-Using Men Who have Sex with Men.

PubMed

Reback, Cathy J; Fletcher, Jesse B; Shoptaw, Steven; Mansergh, Gordon

2015-06-01

Fifty-two non-treatment-seeking methamphetamine-using men who have sex with men were enrolled in Project Tech Support, an open-label pilot study to evaluate whether exposure to theory-based [social support theory (SST), social cognitive theory (SCT), and health belief model (HBM)] text messages could promote reductions in HIV sexual risk behaviors and/or methamphetamine use. Multivariable analyses revealed that increased relative exposure to HBM or SCT (vs. SST) text messages was associated with significant reductions in the number of HIV serodiscordant unprotected (i.e., without a condom) anal sex partners, engagement in sex for money and/or drugs, and frequency of recent methamphetamine use; additionally, increased relative exposure to HBM (vs. SCT or SST) messages was uniquely associated with reductions in the overall number of non-primary anal sex partners (all p ≤ 0.05, two-tailed). Pilot data demonstrated that text messages based on the principles of HBM and SCT reduced sentinel HIV risk and drug use behaviors in active methamphetamine users.

The Effect of D-Tagatose on Fructose Absorption in a Rat Model.

PubMed

Williams, Jarrod; Spitnale, Michael; Lodder, Robert

D-tagatose is in development as a medication for the treatment of type 2 diabetes. The effect of oral D-tagatose on the absorption of D-fructose was assessed when co-administered in this study. In the pilot study, male Sprague-Dawley rats were fed C14 labeled fructose and glucose concomitantly to establish dose levels for the treatment group of rats fed C14 labeled fructose together with D-tagatose. Rats were administered 0, 600, 2000, 6000, or 12000 mg/kg of D-tagatose along with 2000 mg/kg of fructose. Blood samples were taken over 60 minutes and were assessed using scintillation counting. 600, 2000, and 6000 mg/kg of D-tagatose decreased fructose absorption by 1%, 26%, and 30% respectively (12000 mg/kg group was stopped short of completion due to intolerance) as measured by AUC of scintillation counts. The 600 and 2000 mg/kg of D-tagatose groups showed no difference in plasma glucose concentrations compared to placebo while a rise in glucose was seen in the 6000 mg/kg of D-tagatose groups. The results indicate that D-tagatose may be useful in reducing fructose absorption, which could lead to a beneficial outcome.

The Effect of D-Tagatose on Fructose Absorption in a Rat Model

PubMed Central

Williams, Jarrod; Spitnale, Michael; Lodder, Robert

2014-01-01

D-tagatose is in development as a medication for the treatment of type 2 diabetes. The effect of oral D-tagatose on the absorption of D-fructose was assessed when co-administered in this study. In the pilot study, male Sprague-Dawley rats were fed C14 labeled fructose and glucose concomitantly to establish dose levels for the treatment group of rats fed C14 labeled fructose together with D-tagatose. Rats were administered 0, 600, 2000, 6000, or 12000 mg/kg of D-tagatose along with 2000 mg/kg of fructose. Blood samples were taken over 60 minutes and were assessed using scintillation counting. 600, 2000, and 6000 mg/kg of D-tagatose decreased fructose absorption by 1%, 26%, and 30% respectively (12000 mg/kg group was stopped short of completion due to intolerance) as measured by AUC of scintillation counts. The 600 and 2000 mg/kg of D-tagatose groups showed no difference in plasma glucose concentrations compared to placebo while a rise in glucose was seen in the 6000 mg/kg of D-tagatose groups. The results indicate that D-tagatose may be useful in reducing fructose absorption, which could lead to a beneficial outcome. PMID:25621289

The effect of billboard design specifications on driving: A pilot study.

PubMed

Marciano, Hadas; Setter, Pe'erly

2017-07-01

Decades of research on the effects of advertising billboards on road accident rates, driver performance, and driver visual scanning behavior, has produced no conclusive findings. We suggest that road safety researchers should shift their focus and attempt to identify the billboard characteristics that are most distracting to drivers. This line of research may produce concrete guidelines for permissible billboards that would be likely to reduce the influence of the billboards on road safety. The current study is a first step towards this end. A pool of 161 photos of real advertising billboards was used as stimuli within a triple task paradigm designed to simulate certain components of driving. Each trial consisted of one ongoing tracking task accompanied by two additional concurrent tasks: (1) billboard observation task; and (2) circle color change identification task. Five clusters of billboards, identified by conducting a cluster analysis of their graphic content, were used as a within variable in one-way ANOVAs conducted on performance level data collected from the multiple tasks. Cluster 5, labeled Loaded Billboards, yielded significantly deteriorated performance on the tracking task. Cluster 4, labeled Graphical Billboards, yielded deteriorated performance primarily on the color change identification task. Cluster 3, labeled Minimal Billboards, had no effect on any of these tasks. We strongly recommend that these clusters be systematically explored in experiments involving additional real driving settings, such as driving simulators and field studies. This will enable validation of the current results and help incorporate them into real driving situations. Copyright © 2017. Published by Elsevier Ltd.

Open-Label Milnacipran for Patients With Persistent Knee Pain 1 Year or Longer After Total Knee Arthroplasty: A Pilot Study

PubMed Central

Bolognesi, Michael P.

2013-01-01

Objective: The current study investigates whether milnacipran is effective in reducing pain and improving function in patients with persistent pain ≥ 1 year after total knee arthroplasty. Method: This was a 12-week open-label study of flexibly dosed milnacipran in patients (N = 5) experiencing chronic persistent knee pain ≥ 1 year following total knee arthroplasty in the absence of new injury, infection, or implant failure. Subjects were identified from October 2010 to August 2011 through the Duke University Medical Center orthopedic clinic (Durham, North Carolina), typically during 1-year postoperative follow-up visits, and were referred by their orthopedic surgeon. Results: Milnacipran treatment was associated with reduction in pain according to the primary outcome measure of the visual analog scale (VAS) score for pain (effect size of 1.15) and secondary outcome measures of Knee Society Score (KSS) evaluation subscale score (effect size of 1.37) and Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) bodily pain subscale (effect size of 1.16) at week 12. Secondary outcome measures of functional change were mixed in such that, at week 12, the SF-36 physical functioning subscale showed improvement (effect size of 1.16), but the KSS function subscale score was just below the threshold for meaningful effect size (0.98). Conclusions: Open-label milnacipran demonstrated reduced pain and some evidence of functional improvement in this small sample of patients with chronic persistent pain 1 year or more after total knee arthroplasty such that well-powered studies are warranted. Trial Registration: ClinicalTrials.gov identifier: NCT01780389 PMID:24392250

Process and Formulation Effects on Protein Structure in Lyophilized Solids using Mass Spectrometric Methods

PubMed Central

Iyer, Lavanya K.; Sacha, Gregory A.; Moorthy, Balakrishnan S.; Nail, Steven L.; Topp, Elizabeth M.

2016-01-01

Myoglobin (Mb) was lyophilized in the absence (Mb-A) and presence (Mb-B) of sucrose in a pilot-scale lyophilizer with or without controlled ice nucleation. Cake morphology was characterized using scanning electron microscopy (SEM) and changes in protein structure were monitored using solid-state Fourier-transform infrared spectroscopy (ssFTIR), solid-state hydrogen-deuterium exchange-mass spectrometry (ssHDX-MS) and solid-state photolytic labeling-mass spectrometry (ssPL-MS). The results showed greater variability in nucleation temperature and irregular cake structure for formulations lyophilized without controlled nucleation. Controlled nucleation resulted in nucleation at ~ −5 °C and uniform cake structure. Formulations containing sucrose showed better retention of protein structure by all measures than formulations without sucrose. Samples lyophilized with and without controlled nucleation were similar by most measures of protein structure. However, ssPL-MS showed the greatest pLeu incorporation and more labeled regions for Mb-B lyophilized with controlled nucleation. The data support the use of ssHDX-MS and ssPL-MS to study formulation and process-induced conformational changes in lyophilized proteins. PMID:27044943

South African farm workers' interpretation of risk assessment data expressed as pictograms on pesticide labels

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

Rother, Hanna-Andrea

Pesticide companies and regulators in developing countries use the United Nations Food and Agricultural Organization (FAO) recommended pictograms on pesticide labels to communicate risk information based on toxicological and environmental risk assessment data. The pesticide label not only is often the only access people have to pesticide risk information, but also in many countries is a legally binding document. As a result of the crucial role pesticide labels play in protecting health and the environment and as a legal instrument, pictograms are used to overcome literacy challenges in transmitting pesticide risk information. Yet, this risk communication tool is often pronemore » to misinterpretations of the risk information which results in hazardous exposures to pesticides for farm workers and end-users generally. In this paper, results are presented from a study with 115 farm workers on commercial vineyards in the Western Cape, South Africa, assessing their interpretations of 10 commonly used pictograms. A standardized questionnaire based on four commonly used pesticide labels was administered. Overall, 50% or more of the study farm workers had misleading, incorrect and critically confused interpretations of the label pictograms. Interpretations often reflected farm workers' social and cultural frames of reference rather than the technically intended risk information. For example, the pictogram indicating a pesticide's toxicity requires boots must be worn, evoked interpretations of 'dangerous to pedestrians' and 'don't walk through pesticides'. Furthermore, there was a gender variation in pictogram comprehension whereby males generally had more correct interpretations than females. This is a result both of a lack of training for women who are assumed to not work with pesticides, as well as a lack of pictograms relevant for female exposures. These findings challenge the viability of the United Nations current initiative to globally harmonize pictograms used on all chemical labels under the new Globally Harmonized System for the Classification and Labelling of Chemicals (GHS). Particularly as the GHS pictograms were not piloted prior to adoption of the system and represent complex risk assessment data such as chronic hazards. Public health and pesticide policy, backed by relevant research, need to address developing applicable and effective pesticide risk communication tools, particularly for developing country populations. Merely providing risk assessment derived information in a pictogram does not ensure that an end-user will interpret the message as intended and be able to make risk decisions which mitigate risks from exposures to pesticides or chemicals in general.« less

Once-daily, oral levofloxacin monotherapy for low-risk neutropenic fever in cancer patients: a pilot study in China

PubMed Central

He, Lixian; Zhao, Su; Weng, Heng; Yang, Guowang

2015-01-01

This pilot study assesses the safety and efficacy of once-daily, oral levofloxacin monotherapy in Chinese patients with low-risk febrile neutropenia. In this prospective, single-arm, open-label, multicenter clinical trial, 46 adult Chinese patients with solid tumors and low-risk febrile neutropenia were included. Patients received oral levofloxacin monotherapy (500 mg orally/day) until day 12, followed by 7 days of follow-up (day 19). Body temperature was measured three times per day. On days 2, 3, 5–7, 9, 12, and 19, disease symptoms and vital signs were recorded, adverse drug reactions were assessed, and blood samples were collected to determine the whole-blood cell count and the absolute neutrophil count. Blood cultures and chest radiographs were performed simultaneously until negative results were found. Oral levofloxacin was effective and well tolerated in 97.6% of patients irrespective of the cancer type and cause of fever. Body temperature began to decline in 24.4, 68.3, and 90.2% of patients, respectively, at 12, 24, and 48 h after initiating levofloxacin therapy. On days 5 and 7, 95.1 and 97.6% of the patients had complete defervescence, respectively. The median time for absolute neutrophil count recovery to at least 1500/mm3 after initiation of treatment was 3 days. Only one patient reported mild diarrhea. This pilot study showed that oral levofloxacin quickly and effectively reduced fever, initiated neutrophil recovery, and was well tolerated in Chinese low-risk febrile neutropenic patients with solid tumors. Further study is needed to compare patient data of levofloxacin with the standard amoxicillin/ciprofloxacin protocol in this population for both safety and efficacy. PMID:25486597

Greater than 95% success with 14-day bismuth quadruple anti- Helicobacter pylori therapy: a pilot study in US Hispanics.

PubMed

Salazar, Cesar O; Cardenas, Victor M; Reddy, Rita K; Dominguez, Delfina C; Snyder, Lindsey K; Graham, David Y

2012-10-01

A combination capsule of bismuth, metronidazole, and tetracycline plus omeprazole given as 10-day therapy has an overall effectiveness of 92-93% in per-protocol analysis (Grade B) with eradication of 86-91% of metronidazole-resistant Helicobacter pylori. This study aimed to explore whether extending the duration to 14 days would improve overall effectiveness per protocol to ≥95% (Grade A) in a population in which metronidazole resistance was anticipated to exist. A one-arm, open-label pilot study of H. pylori-infected, asymptomatic/mildly dyspeptic adults, Hispanic residents of El Paso, Texas, received a 14-day course of omeprazole, plus the combination capsule. We cultured and Gram-stained specimens obtained using a minimally invasive orogastric brush. Helicobacter pylori status was determined by (13)C-urea breath test at 4 or more weeks post-therapy. Forty-seven subjects (7 men and 40 women, average age 42 years) were entered. The per-protocol effectiveness was 97.1% (33/34) (95% mid-P CI: 86.3, 99.9); 100% of metronidazole-resistant strains were eradicated. Side effects were mild and self-limited but contributed to nonadherence. Therapy taken for <10 days was more likely to result in eradication failure (p < .001). Office-based orogastric brushing was well tolerated; positive cultures were obtained in 95%. Gram staining showed H. pylori-like forms in all specimens. This pilot study supports the concept that 14-day OBMT therapy is likely to be more efficacious for H. pylori eradication (Grade A, PP basis) than a 10-day course where metronidazole resistance is suspected. If confirmed, 14 days should be recommended in populations where metronidazole resistance is common. © 2012 Blackwell Publishing Ltd.

Therapeutic effect of intranasal evaporative cooling in patients with migraine: a pilot study.

PubMed

Vanderpol, Jitka; Bishop, Barbara; Matharu, Manjit; Glencorse, Mark

2015-01-26

Cryotherapy is the most common non-pharmacological pain-relieving method. The aim of this pilot study was to ascertain whether intranasal evaporative cooling may be an effective intervention in an acute migraine attack. Studies have previously demonstrated effectiveness of a variety of cryotherapy approaches. Intranasal evaporative cooling due to vascular anatomy, allows the transfer of venous blood from nasal and paranasal mucous membranes to the dura mater, thereby providing an excellent anatomical basis for the cooling processes. We conducted a prospective, open-label, observational, pilot study. Twenty-eight patients who satisfied the International Classification of Headache Disorders (ICHD 2) diagnostic criteria for migraine were recruited. A total of 20 treatments were administered in 15 patients. All patients provided pain severity scores and migraine-associated symptoms severity scores (based on a 0-10 visual analogue scale, [VAS]). Out of the 20 treatments, intranasal evaporative cooling rendered patients' pain and symptoms free immediately after treatment, in 8 of the treatments (40%), a further 10 treatments (50%) resulted in partial pain relief (headache reduced from severe or moderate to mild) and partial symptoms relief. At 2 hours, 9 treatments (45%) provided full pain and symptoms relief, with a further 9 treatments (45%) resulting in partial pain and symptoms relief. At 24 hours, 10 treatments (50%) resulted in patients reporting pain and symptom freedom and 3 (15%) provided partial pain relief. In summary 13 patients (87%) had benefit from the treatment within 2 hours that was sustained at 24 hours. Intranasal evaporative cooling gave considerable benefit to patients with migraine, improving headache severity and migraine-associated symptoms. A further randomised, placebo controlled, double blinded, parallel clinical trial is required to further investigate the potential of this application. Clinicaltrials.gov registered trial, ClinicalTrials.gov Identifier: NCT01898455.

A pilot study of oxcarbazepine versus acamprosate in alcohol-dependent patients.

PubMed

Croissant, Bernhard; Diehl, Alexander; Klein, Oliver; Zambrano, Sergio; Nakovics, Helmut; Heinz, Andreas; Mann, Karl

2006-04-01

This pilot study has been designed to collect preliminary data on the use of a new antiepileptic drug in the management of alcoholic patients. Oxcarbazepine (OXC) blocks voltage-sensitive sodium channels. Its metabolite reduces high-voltage-activated calcium currents in striatal and cortical neurons, thus reducing glutamatergic transmission at corticostriatal synapses. This reduction is of interest in the treatment of alcohol dependence, as acamprosate (ACP) modulates NMDA receptors, resulting in an inhibition of glutamatergic transmission. Furthermore, OXC has revealed a mood-stabilizing effect in bipolar affective disorders. We have compared OXC with ACP in relapse prevention in recently withdrawn alcohol-dependent patients. We investigated the efficacy and safety of OXC (vs ACP) by conducting a 24-week randomized, parallel-group, open-label, clinical trial on 30 acutely detoxified alcoholic patients. Survival analyses (Kaplan-Meier) were performed to look for evidence of a longer "survival" of patients receiving OXC. We assessed time to first severe relapse and additional secondary endpoints. After withdrawal, time to severe relapse and time to first consumption of any ethanol by OXC patients were not longer than for ACP patients. Abstinent patients in both study groups showed a significantly lower obsessive compulsive drinking scale-German version (OCDS-G) than relapsed patients. No undesired effects occurred when OXC patients consumed alcohol. Our findings indicate that it could be worthwhile to test relapse prevention using OXC in an adequate sample. While the current sample size clearly limits further conclusions from this pilot study, it is noteworthy that OXC is well tolerated, even when alcohol is on board. Thus, in medication-based relapse prevention, OXC could be a promising alternative for alcoholic patients unable to benefit from ACP or naltrexone or those who have affective liability. OXC certainly merits a larger placebo-controlled trial.

Hidden Markov models reveal complexity in the diving behaviour of short-finned pilot whales

PubMed Central

Quick, Nicola J.; Isojunno, Saana; Sadykova, Dina; Bowers, Matthew; Nowacek, Douglas P.; Read, Andrew J.

2017-01-01

Diving behaviour of short-finned pilot whales is often described by two states; deep foraging and shallow, non-foraging dives. However, this simple classification system ignores much of the variation that occurs during subsurface periods. We used multi-state hidden Markov models (HMM) to characterize states of diving behaviour and the transitions between states in short-finned pilot whales. We used three parameters (number of buzzes, maximum dive depth and duration) measured in 259 dives by digital acoustic recording tags (DTAGs) deployed on 20 individual whales off Cape Hatteras, North Carolina, USA. The HMM identified a four-state model as the best descriptor of diving behaviour. The state-dependent distributions for the diving parameters showed variation between states, indicative of different diving behaviours. Transition probabilities were considerably higher for state persistence than state switching, indicating that dive types occurred in bouts. Our results indicate that subsurface behaviour in short-finned pilot whales is more complex than a simple dichotomy of deep and shallow diving states, and labelling all subsurface behaviour as deep dives or shallow dives discounts a significant amount of important variation. We discuss potential drivers of these patterns, including variation in foraging success, prey availability and selection, bathymetry, physiological constraints and socially mediated behaviour. PMID:28361954

A pilot study: the efficacy of virgin coconut oil as ocular rewetting agent on rabbit eyes.

PubMed

Mutalib, Haliza Abdul; Kaur, Sharanjeet; Ghazali, Ahmad Rohi; Chinn Hooi, Ng; Safie, Nor Hasanah

2015-01-01

Purpose. An open-label pilot study of virgin coconut oil (VCO) was conducted to determine the safety of the agent as ocular rewetting eye drops on rabbits. Methods. Efficacy of the VCO was assessed by measuring NIBUT, anterior eye assessment, corneal staining, pH, and Schirmer value before instillation and at 30 min, 60 min, and two weeks after instillation. Friedman test was used to analyse any changes in all the measurable variables over the period of time. Results. Only conjunctival redness with instillation of saline agent showed significant difference over the period of time (P < 0.05). However, further statistical analysis had shown no significant difference at 30 min, 60 min, and two weeks compared to initial measurement (P > 0.05). There were no changes in the NIBUT, limbal redness, palpebral conjunctiva redness, corneal staining, pH, and Schirmer value over the period of time for each agent (P > 0.05). Conclusion. VCO acts as safe rewetting eye drops as it has shown no significant difference in the measurable parameter compared to commercial brand eye drops and saline. These study data suggest that VCO is safe to be used as ocular rewetting agent on human being.

Effect of Atomoxetine on the Cognitive Functions in Treatment of Attention Deficit Hyperactivity Disorder in Children with Congenital Hypothyroidism: A Pilot Study.

PubMed

Yang, Rongwang; Gao, Weijia; Li, Rong; Zhao, Zhengyan

2015-04-19

With early initiation of thyroxine supplementation, children with congenital hypothyroidism (CH) retain some subtle deficits, such as attention and inhibitory control problems. This study assessed the effects of atomoxetine on cognitive functions in treatment of attention deficit hyperactivity disorder (ADHD) symptoms in children with CH. In a 6-month, open-labeled pilot study, 12 children were recruited and received atomoxetine. The measures of efficacy were scores on the Swanson, Nolan and Pelham Teacher and Parent Rating Scale, version IV (SNAP-IV) and Clinical Global Impression-Severity scale (CGI-S). The cognitive functions were evaluated with the Wechsler Intelligence Scale for Chinese Children, Digit Span, Wisconsin Card Sorting Test, and Stroop test. A statistically significant difference was found between the mean CGI-S and SNAP-IV scores before and after treatment (p < 0.01). All the indicators of cognitive functions at the endpoint were improved compared with those at baseline. No serious adverse events were reported. Atomoxetine appears to be useful in improving ADHD symptoms, as well as cognitive functions, in children with CH. Larger, randomized, double-blinded, clinical trials are required to replicate these results. © The Author 2015. Published by Oxford University Press on behalf of CINP.

A Pilot Study: The Efficacy of Virgin Coconut Oil as Ocular Rewetting Agent on Rabbit Eyes

PubMed Central

Mutalib, Haliza Abdul; Kaur, Sharanjeet; Ghazali, Ahmad Rohi; Chinn Hooi, Ng; Safie, Nor Hasanah

2015-01-01

Purpose. An open-label pilot study of virgin coconut oil (VCO) was conducted to determine the safety of the agent as ocular rewetting eye drops on rabbits. Methods. Efficacy of the VCO was assessed by measuring NIBUT, anterior eye assessment, corneal staining, pH, and Schirmer value before instillation and at 30 min, 60 min, and two weeks after instillation. Friedman test was used to analyse any changes in all the measurable variables over the period of time. Results. Only conjunctival redness with instillation of saline agent showed significant difference over the period of time (P < 0.05). However, further statistical analysis had shown no significant difference at 30 min, 60 min, and two weeks compared to initial measurement (P > 0.05). There were no changes in the NIBUT, limbal redness, palpebral conjunctiva redness, corneal staining, pH, and Schirmer value over the period of time for each agent (P > 0.05). Conclusion. VCO acts as safe rewetting eye drops as it has shown no significant difference in the measurable parameter compared to commercial brand eye drops and saline. These study data suggest that VCO is safe to be used as ocular rewetting agent on human being. PMID:25802534

Clinical Validation of Therapeutic Drug Monitoring of Imipenem in Spent Effluent in Critically Ill Patients Receiving Continuous Renal Replacement Therapy: A Pilot Study.

PubMed

Wen, Aiping; Li, Zhe; Yu, Junxian; Li, Ren; Cheng, Sheng; Duan, Meili; Bai, Jing

2016-01-01

The primary objective of this pilot study was to investigate whether the therapeutic drug monitoring of imipenem could be performed with spent effluent instead of blood sampling collected from critically ill patients under continuous renal replacement therapy. A prospective open-label study was conducted in a real clinical setting. Both blood and effluent samples were collected pairwise before imipenem administration and 0.5, 1, 1.5, 2, 3, 4, 6, and 8 h after imipenem administration. Plasma and effluent imipenem concentrations were determined by reversed-phase high-performance liquid chromatography with ultraviolet detection. Pharmacokinetic and pharmacodynamic parameters of blood and effluent samples were calculated. Eighty-three paired plasma and effluent samples were obtained from 10 patients. The Pearson correlation coefficient of the imipenem concentrations in plasma and effluent was 0.950 (P<0.0001). The average plasma-to-effluent imipenem concentration ratio was 1.044 (95% confidence interval, 0.975 to 1.114) with Bland-Altman analysis. No statistically significant difference was found in the pharmacokinetic and pharmacodynamic parameters tested in paired plasma and effluent samples with Wilcoxon test. Spent effluent of continuous renal replacement therapy could be used for therapeutic drug monitoring of imipenem instead of blood sampling in critically ill patients.

Meta-Analysis of the Prevalence of Unacknowledged Rape.

PubMed

Wilson, Laura C; Miller, Katherine E

2016-04-01

Many sexual violence survivors do not label their experiences as rape but instead use more benign labels, such as "bad sex" or "miscommunication." A meta-analysis was conducted to estimate the mean prevalence of unacknowledged rape and to inform our understanding of methodological factors that influence the detection of this phenomenon. Studies were identified using PsycINFO, PubMED, and PILOTS and were required to report the percentage of unacknowledged rape that had occurred since the age of 14 among female survivors. Moderator variables included mean participant age, recruitment source, rape definition, and unacknowledged rape definition. Twenty-eight studies (30 independent samples) containing 5,917 female rape survivors met the inclusion criteria. Based on a random effects model, the overall weighted mean percentage of unacknowledged rape was 60.4% (95% confidence interval [55.0%, 65.6%]). There was a large amount of heterogeneity, Q(29) = 445.11, p < .001, and inconsistency (I(2) = 93.5%) among included studies. The prevalence was significantly higher among college student participants compared to noncollege participants. The findings supported that over half of all female rape survivors do not acknowledge that they have been raped. The results suggest that screening tools should use behaviorally descriptive items about sexual contact, rather than using terms such as "rape." © The Author(s) 2015.

Clinical Efficacy and Safety of Oral Qing-Dai in Patients with Ulcerative Colitis: A Single-Center Open-Label Prospective Study.

PubMed

Sugimoto, Shinya; Naganuma, Makoto; Kiyohara, Hiroki; Arai, Mari; Ono, Keiko; Mori, Kiyoto; Saigusa, Keiichiro; Nanki, Kosaku; Takeshita, Kozue; Takeshita, Tatsuya; Mutaguchi, Makoto; Mizuno, Shinta; Bessho, Rieko; Nakazato, Yoshihiro; Hisamatsu, Tadakazu; Inoue, Nagamu; Ogata, Haruhiko; Iwao, Yasushi; Kanai, Takanori

2016-01-01

Chinese herbal medicine Qing-Dai (also known as indigo naturalis) has been used to treat various inflammatory conditions. However, not much has been studied about the use of oral Qing-Dai in the treatment for ulcerative colitis (UC) patients. Studies exploring alternative treatments for UC are of considerable interest. In this study, we aimed at prospectively evaluating the safety and efficacy of Qing-Dai for UC patients. The open-label, prospective pilot study was conducted at Keio University Hospital. A total of 20 patients with moderate UC activity were enrolled. Oral Qing-Dai in capsule form was taken twice a day (daily dose, 2 g) for 8 weeks. At week 8, the rates of clinical response, clinical remission, and mucosal healing were 72, 33, and 61%, respectively. The clinical and endoscopic scores, CRP levels, and fecal occult blood results were also significantly improved. We observed 2 patients with mild liver dysfunction; 1 patient discontinued due to infectious colitis and 1 patient discontinued due to mild nausea. This is the first prospective study indicating that oral Qing-Dai is effective for inducing remission in patients with moderate UC activity and can be tolerated. Thus, Qing-Dai may be considered an alternative treatment for patients, although further investigation is warranted. © 2016 S. Karger AG, Basel.

Astronauts Stafford and Slayton visit Soviet Soyuz spacecraft

NASA Technical Reports Server (NTRS)

1975-01-01

Astronauts Thomas P. Stafford, left, NASA ASTP crew commander, and Donald K. Slayton, docking module pilot, visit the Soviet Soyuz spacecraft during the joint phase of the ASTP mission. They hold Soviet containers of borsh (beet soup) over which vodka labels have been pasted. This was the crew's way of toasting each other. The photo was taken in the Orbital Module portion of the Soviet Soyuz spacecraft. The hatch to the Soyuz Descent Vehicle is in center background.

A pilot food store intervention in the Republic of the Marshall Islands.

PubMed

Gittelsohn, Joel; Dyckman, William; Frick, Kevin D; Boggs, Malia K; Haberle, Heather; Alfred, Julia; Vastine, Amy; Palafox, Neal

2007-09-01

To improve diet and reduce risk for obesity and chronic disease, we developed, implemented and evaluated a pilot intervention trial with 23 large and small food stores in the Republic of the Marshall Islands (12 intervention, 11 control). The intervention included both mass media (radio announcements, newspaper ads, video) and in-store (cooking demonstrations, taste tests, shelf labeling) components. Consumer exposure to the mass media components was high (65% had heard half or more of the radio announcements, 74% had seen at least one of the newspaper ads). Consumer exposure to the in-store components of the intervention was moderate (61% attended at least one cooking demonstrations, 59% received at least one recipe card). After adjustment for age, sex and education level, increased exposure to the intervention was associated with higher diabetes knowledge (p<0.05) and label reading knowledge (p<0.05), but not with increased self-efficacy for performing promoted healthy behaviors. The intervention was associated with increased purchasing of certain promoted foods (p<0.005), including oatmeal, turkey chili, fish, canned fruit and local vegetables. It was also associated with improvements in healthiness of cooking methods (p<0.05). Food store centered interventions have great potential for changing cognitive and behavioral factors relating to food choice and preparation, and may contribute to lessening the burden of diet-related chronic disease worldwide.

Use of Earth Observing Satellite Data for the Development of "Learning Exercises" for College-Level Science Courses

NASA Technical Reports Server (NTRS)

Joyce, Armond T.

1998-01-01

This paper is based on experiences being gained through a project entitled "The Mississippi Community College Pilot Project". The project was labeled "pilot" because it is thought that lessons learned during the implementation of this project may aid similar endeavors in other states. The objective of the project is to provide curriculum enrichment and associated faculty enhancement through the use of earth observations data in biological and physical sciences courses. The premise underlying the objective is that information from earth observations from satellite and aircraft platforms provides an effective means of illustrating and explaining science topics/phenomena in a new and/or different perspective. It is also thought that the use of data acquired from space may also serve to captivate the students interest and/or inquisitiveness about the particular science issue.

[Knowledge and use of nutrient labelling of industrialized foods and beverages in Mexico].

PubMed

Tolentino-Mayo, Lizbeth; Rincón-Gallardo Patiño, Sofía; Bahena-Espina, Liliana; Ríos, Víctor; Barquera, Simón

2018-01-01

To keep record of the knowledge and use of information of the different food labels on industrialized products in Mexico. We administered a semi-structured survey-developed by research¬ers free of conflict interestin a subsample of the National Health and Nutrition Survey, 2016. This survey was previously validated and piloted in different populations of varying socio¬economic levels and age and country regions. Data was collected from a total of 8 667 individuals ≥20 years of age. The most frecuent type of label on industrialized foods and beverages was the nutrient table with 41.5% (95%CI 36.9- 46.3) and the least used was the nutrient seal, 4.3% (95%CI 3.1-5.7). It is of critical importance that the regulating authorities and the Ministry of Health, implement criteria that guarantee the compliance of recommendations promulgated in official documents. As well as the standarization of the percentage of recommended sugar intake based on WHO standards or lower considering the epidemiological alert for diabetes that the country is experiencing.

PlenadrEMA: effect of dual-release versus conventional hydrocortisone on fatigue, measured by ecological momentary assessments: a study protocol for an open-label switch pilot study.

PubMed

Boesen, Victor Brun; Christoffersen, Thea; Watt, Torquil; Borresen, Stina Willemoes; Klose, Marianne; Feldt-Rasmussen, Ulla

2018-01-23

Patients with adrenal insufficiency have impaired health-related quality of life (QoL). The dual-release hydrocortisone preparation, Plenadren, has been developed to mimic the physiological cortisol release more closely than conventional hydrocortisone treatment. Plenadren has been shown to improve QoL, in particular fatigue, in patients with primary adrenal insufficiency. However, the effect has not been investigated in patients with secondary adrenal insufficiency; furthermore, no study has taken the diurnal variation of fatigue into account. To assess diurnal variations, it is necessary to use repeated daily measurements, such as ecological momentary assessments (EMAs). This study aims to evaluate EMAs of fatigue as outcome in future large-scale randomised clinical trials. The PlenadrEMA trial is an investigator-initiated open-label switch pilot trial of the effect of Plenadren versus conventional hydrocortisone on fatigue in patients with secondary adrenal insufficiency. The trial will include 30 participants. After 5 weeks on their usual hydrocortisone treatment, patients will be shifted to Plenadren for 16 weeks. Fatigue will be assessed using momentary versions of the Multidimensional Fatigue Inventory (MFI-20). Items will be administered to participants via a smartphone application four times daily during 20 days. Assessments will be performed before treatment shift and repeated after 12.5 weeks on Plenadren. The study will identify the best suited outcome for future randomised clinical trials, and in addition, estimate the variability and difference in fatigue between the two treatments to perform power calculations. The trial will be conducted in accordance with the Declaration of Helsinki and has been approved by the Regional Scientific Ethical Committee in Copenhagen (ID: H-1-2014-073). All patients will receive written and verbal information about the trial and will give informed consent before enrolment. Findings will be published in peer-reviewed journals and presented at international conferences. EudraCT201400203932. © 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.

Catering Gluten-Free When Simultaneously Using Wheat Flour.

PubMed

Miller, Kathryn; McGough, Norma; Urwin, Heidi

2016-02-01

A European law on gluten-free (GF) labeling came into force in 2012, covering foods sold prepacked and in food service establishments, and a similar U.S. Food and Drug Administration (FDA) regulation covers GF labeling from August 2014. Gluten is found in the grains wheat, rye, and barley. A common source of gluten in the kitchen is wheat flour. This research aimed to determine variables that have a significant effect on gluten contamination in commercial kitchens when wheat flour is in use and to establish controls necessary to assure GF production. A pilot study was used to test the following hypotheses: (i) increasing duration of exposure to wheat flour would increase gluten contamination, (ii) increasing distance between the site of preparation and the site of wheat flour would reduce gluten contamination, (iii) the use of a ventilation hood would decrease gluten contamination, and (iv) the use of a barrier segregating the site of preparation of a GF meal and the use of wheat flour would decrease gluten contamination. Petri dishes containing GF rice pudding were placed in three directions at increasing distances (0.5 to 2 m) from a site of wheat flour use. A barrier was in place between a third of samples and the site of wheat flour. After wheat flour was handled for 0.5 and 4.0 h, petri dishes were sealed and the contents were analyzed for gluten. The experiment was duplicated with the ventilation hood on and off. The pilot study revealed that a distance of 2 m from the use of wheat flour was required to control gluten contamination at ≤20 ppm if wheat flour had been in use for 4.0 h. The identified control of distance was tested in five different study sites. In each of the study sites, a test meal was prepared a minimum of 2 m away from the site of wheat flour use. Although kitchens vary and must be considered individually, the established control of a minimum 2 m distance, along with good hygiene practices, was found to be effective in preparing GF meals at all five study sites.

Low-dose rapamycin (sirolimus) effects in autosomal dominant polycystic kidney disease: an open-label randomized controlled pilot study.

PubMed

Braun, William E; Schold, Jesse D; Stephany, Brian R; Spirko, Rita A; Herts, Brian R

2014-05-01

The two largest studies of mammalian target of rapamycin inhibitor treatment of autosomal dominant polycystic kidney disease (ADPKD) demonstrated no clear benefit on the primary endpoint of total kidney volume (TKV) or on eGFR. The present study evaluated two levels of rapamycin on the 12-month change in (125)I-iothalamate GFR (iGFR) as the primary endpoint and TKV secondarily. In a 12-month open-label pilot study, 30 adult patients with ADPKD were randomly assigned to low-dose (LD) rapamycin (rapamycin trough blood level, 2-5 ng/ml) (LD group, n=10), standard-dose (STD) rapamycin trough level (>5-8 ng/ml) (STD group, n=10), or standard care (SC group, n=10). They were evaluated with iGFR and noncontrast computed tomography. Change in iGFR at 12 months was significantly higher in the LD group (7.7±12.5 ml/min per 1.73 m(2); n=9) than in the SC group (-11.2 ± 9.1 ml/min per 1.73 m(2); n=9) (LD versus SC: P<0.01). Change in iGFR at 12 months in the STD group (1.6 ± 12.1 ml/min per 1.73 m(2); n=8) was not significantly greater than that in the SC group (P=0.07), but it was in the combined treatment groups (LD+STD versus SC: P<0.01). Neither eGFR calculated by the CKD-Epidemiology Collaboration equation nor TKV (secondary endpoint) changed significantly from baseline to 12 months in any of the groups. On the basis of results of the mixed model, during the study, patients in the LD group had significantly lower trough blood levels of rapamycin (mean range ± SD, 2.40 ± 0.64 to 2.90 ± 1.20 ng/ml) compared with those in the STD group (3.93 ± 2.27 to 5.77 ± 1.06 ng/ml) (P<0.01). Patients with ADPKD receiving LD rapamycin demonstrated a significant increase in iGFR compared with those receiving standard care, without a significant effect on TKV after 12 months.

Rifaximin in non-alcoholic steatohepatitis: An open-label pilot study.

PubMed

Cobbold, Jeremy F L; Atkinson, Stephen; Marchesi, Julian R; Smith, Ann; Wai, Sann N; Stove, Julie; Shojaee-Moradie, Fariba; Jackson, Nicola; Umpleby, A Margot; Fitzpatrick, Julie; Thomas, E Louise; Bell, Jimmy D; Holmes, Elaine; Taylor-Robinson, Simon D; Goldin, Robert D; Yee, Michael S; Anstee, Quentin M; Thursz, Mark R

2018-01-01

Gut microbial dysbiosis is implicated in the pathogenesis of non-alcoholic steatohepatitis (NASH). We investigated downstream effects of gut microbiota modulation on markers of hepatic inflammation, steatosis, and hepatic and peripheral insulin sensitivity in patients with NASH using rifaximin therapy. Patients with biopsy-proven NASH and elevated aminotransferase values were included in this open-label pilot study, all receiving 6 weeks rifaximin 400 mg twice daily, followed by a 6-week observation period. The primary endpoint was change in alanine aminotransferase (ALT) after 6 weeks of rifaximin. Secondary endpoints were change in hepatic lipid content and insulin sensitivity measured with a hyperinsulinemic-euglycemic clamp. Fifteen patients (13 men and 2 women) with a median (range) age of 46 (32-63) years were included. Seven had diabetes on oral hypoglycemic medications and 8 had no diabetes. After 6 weeks of therapy, no differences were seen in ALT (55 [33-191] vs. 63 [41-218] IU/L, P = 0.41), peripheral glucose uptake (28.9 [19.4-48.3] to 25.5 [17.7-47.9] μmol/kg/min, P = 0.30), hepatic insulin sensitivity (35.2 [15.3-51.7]% vs. 30.0 [10.8-50.5]%, P = 0.47), or hepatic lipid content (21.6 [2.2-46.2]% vs. 24.8 [1.7-59.3]%, P = 0.59) before and after rifaximin treatment. After 12 weeks from baseline, serum ALT increased to 83 (30-217) IU/L, P = 0.02. There was a significant increase in the homeostasis model assessment-estimated insulin resistance index (P = 0.05). The urinary metabolic profile indicated a significant reduction in urinary hippurate with treatment, which reverted to baseline after cessation of rifaximin, although there was no consistent difference in relative abundance of fecal microbiota with treatment. These data do not indicate a beneficial effect of rifaximin in patients with NASH. © 2017 The Japan Society of Hepatology.

Daily subcutaneous parecoxib injection for cancer pain: an open label pilot study.

PubMed

Kenner, David J; Bhagat, Sandeep; Fullerton, Sonia L

2015-04-01

Nonsteroidal anti-inflammatory analgesics (NSAIDs) are useful in cancer pain but the specific use of subcutaneous parecoxib has not been previously reported. This pilot study aimed to establish the efficacy and side effect profile of short-term sequential single daily dose subcutaneous parecoxib sodium in patients with severe cancer bone pain. Nineteen hospitalized patients with advanced cancer and uncontrolled malignant bone pain (9 males, 10 females) received 24 courses of one, two, or three days sequential therapy with 'off-label' daily subcutaneous parecoxib. All patients were receiving opioid therapy; the median baseline daily oral equivalent dose (OED) of morphine was 180 mg. Pain was assessed at baseline, 24 hours, 48 hours, and 72 hours. Pain scores as assessed on an 11-point numeric pain rating scale (NPRS), any side effects including subcutaneous site reactions, as well as patient satisfaction rating with analgesia were recorded. A clinically significant decrease in pain scores was defined as a reduction of two or more points on the NPRS. Median pain score of all patient treatments decreased from 7 to 4.5 at 24 hours (p<0.001) and 4.0 at 48 hours. A response was seen in 17 (71%) of the 24 treatments at 24 hours. There was no difference between median negative change in pain scores in 19 (79%) treatments where pain was either strongly movement related, or in 22 (94%) treatments where local bone tenderness was more pronounced. No major side effects were observed during treatment. One patient died from pulmonary embolism after cessation of concurrent prophylactic low molecular weight heparin prior to staging liver biopsy. Subcutaneous site reactions occurred in 2 (8%) treatments and were mild and self limiting. Short-term daily subcutaneous parecoxib injection was effective for malignant bone pain when added to existing analgesic therapy and was well tolerated. Further research is warranted into the short-term use of parecoxib in hospitalized patients with intractable malignant bone pain.

Home use of binocular dichoptic video content device for treatment of amblyopia: a pilot study.

PubMed

Mezad-Koursh, Daphna; Rosenblatt, Amir; Newman, Hadas; Stolovitch, Chaim

2018-04-01

To evaluate the efficacy of the BinoVision home system as measured by improvement of visual acuity in the patient's amblyopic eye. An open-label prospective pilot-trial of the system was conducted with amblyopic children aged 4-8 years at the pediatric ophthalmology unit, Tel-Aviv Medical Center, January 2014 to October 2015. Participants were assigned to the study or sham group for treatment with BinoVision for 8 or 12 weeks. Patients were instructed to watch animated television shows and videos at home using the BinoVision device for 60 minutes, 6 days a week. The BinoVision program incorporates elements at different contrast and brightness levels for both eyes, weak eye tracking training by superimposed screen images, and weak eye flicker stimuli with alerting sound manipulations. Patients were examined at 4, 8, 12, 24, and 36 weeks. A total of 27 children were recruited (14 boys), with 19 in the treatment group. Median age was 5 years (range, 4-8 years). Mean visual acuity improved by 0.26 logMAR lines in the treatment group from baseline to 12 weeks. Visual acuity was improved compared to baseline during all study and follow-up appointments (P < 0.01), with stabilization of visual acuity after cessation of treatment. The sham group completed 4 weeks of sham protocol with no change in visual acuity (P = 0.285). The average compliance rate was 88% ± 16% (50% to 100%) in treatment group. This pilot trial of 12 weeks of amblyopia treatment with the BinoVision home system demonstrated significant improvement in patients' visual acuity. Copyright © 2018 American Association for Pediatric Ophthalmology and Strabismus. Published by Elsevier Inc. All rights reserved.

A Two-Year Randomized Trial of Interventions to Decrease Stress Hormone Vasopressin Production in Patients with Meniere's Disease-A Pilot Study.

PubMed

Kitahara, Tadashi; Okamoto, Hidehiko; Fukushima, Munehisa; Sakagami, Masaharu; Ito, Taeko; Yamashita, Akinori; Ota, Ichiro; Yamanaka, Toshiaki

2016-01-01

Meniere's disease, a common inner ear condition, has an incidence of 15-50 per 100,000. Because mental/physical stress and subsequent increase in the stress hormone vasopressin supposedly trigger Meniere's disease, we set a pilot study to seek new therapeutic interventions, namely management of vasopressin secretion, to treat this disease. We enrolled 297 definite Meniere's patients from 2010 to 2012 in a randomized-controlled and open-label trial, assigning Group-I (control) traditional oral medication, Group-II abundant water intake, Group-III tympanic ventilation tubes and Group-IV sleeping in darkness. Two hundred sixty-three patients completed the planned 2-year-follow-up, which included assessment of vertigo, hearing, plasma vasopressin concentrations and changes in stress/psychological factors. At 2 years, vertigo was completely controlled in 54.3% of patients in Group-I, 81.4% in Group-II, 84.1% in Group-III, and 80.0% in Group-IV (statistically I < II = III = IV). Hearing was improved in 7.1% of patients in Group-I, 35.7% in Group-II, 34.9% in Group-III, and 31.7% in Group-IV (statistically I < II = III = IV). Plasma vasopressin concentrations decreased more in Groups-II, -III, and -IV than in Groups-I (statistically I < II = III = IV), although patients' stress/psychological factors had not changed. Physicians have focused on stress management for Meniere's disease. However, avoidance of stress is unrealistic for patients who live in demanding social environments. Our findings in this pilot study suggest that interventions to decrease vasopressin secretion by abundant water intake, tympanic ventilation tubes and sleeping in darkness is feasible in treating Meniere's disease, even though these therapies did not alter reported mental/physical stress levels. ClinicalTrials.gov NCT01099046.

A pilot study evaluating the safety and efficacy of modafinal for cancer-related fatigue.

PubMed

Blackhall, Leslie; Petroni, Gina; Shu, Jianfen; Baum, Lora; Farace, Elena

2009-05-01

Fatigue is a common symptom that lowers the quality of life of patients with cancer, affecting between 60% and 90% of patients. Relatively few options are available for the treatment of this debilitating condition. Modafinal, a psychostimulant developed for the treatment of narcolepsy, has been used to treat fatigue in other diseases such as multiple sclerosis, but little data support its use in cancer patients. The primary objective of this open-label pilot study was to evaluate the safety, and efficacy of modafinil in improving cancer-related fatigue (CRF) as measured by the Brief Fatigue Inventory (BFI). The effect of this agent on depression, quality of life, functional status, and cognitive function was also assessed. Modafinal was self-administered at a dose of 100 mg/d during weeks 1-2, and 200 mg during weeks 3-4. Assessments were performed at baseline, 2, and 4 weeks. BFI score was improved in 46% of patients at 2 weeks and 75% at 4 weeks (p = 0.025). Hospital Anxiety and Depression Scale scores declined at 2 and 4 weeks (p < 0.001). Most scales for neurocognitive function were unchanged. Score for all Functional Assessment of Cancer Therapy-Brain (FACT-BR) subscales (measuring quality of life), except social/family well-being, were improved (p < 0.05) at 2 and 4 weeks. Significant changes in Eastern Cooperative Oncology Group (ECOG) performance status were noted, with 40% of patients improving at least one level. Modafinil was well-tolerated with only one patient discontinuing treatment due to drug-related toxicity. In this pilot study modafinil was well-tolerated and effective for fatigue in patients with cancer. Improvements were also seen in mood, quality of life, and functional status.

Exploratory analysis of glyburide as a novel therapy for preventing brain swelling.

PubMed

Sheth, Kevin N; Kimberly, W Taylor; Elm, Jordan J; Kent, Thomas A; Yoo, Albert J; Thomalla, Götz; Campbell, Bruce; Donnan, Geoffrey A; Davis, Stephen M; Albers, Gregory W; Jacobson, Sven; del Zoppo, Gregory; Simard, J Marc; Stern, Barney J; Mandava, Pitchaiah

2014-08-01

Malignant infarction is characterized by the formation of cerebral edema, and medical treatment is limited. Preclinical data suggest that glyburide, an inhibitor of SUR1-TRPM4, is effective in preventing edema. We previously reported feasibility of the GAMES-Pilot study, a two-center prospective, open label, phase IIa trial of 10 subjects at high risk for malignant infarction based on diffusion weighted imaging (DWI) threshold of 82 cm(3) treated with RP-1127 (glyburide for injection). In this secondary analysis, we tested the hypothesis that RP-1127 may be efficacious in preventing poor outcome when compared to controls. Controls suffering large hemispheric infarction were obtained from the EPITHET and MMI-MRI studies. We first screened subjects for controls with the same DWI threshold used for enrollment into GAMES-Pilot, 82 cm(3). Next, to address imbalances, we applied a weighted Euclidean matching. Ninety day mRS 0-4, rate of decompressive craniectomy, and mortality were the primary clinical outcomes of interest. The mean age of the GAMES cohort was 51 years and initial DWI volume was 102 ± 23 cm(3). After Euclidean matching, GAMES subjects showed similar NIHSS, higher DWI volume, younger age and had mRS 0-4-90% versus 50% in controls p = 0.049; with a similar trend in mRS 0-3 (40 vs. 25%; p = 0.43) and trend toward lower mortality (10 vs. 35%; p = 0.21). In this pilot study, RP-1127-treated subjects showed better clinical outcomes when compared to historical controls. An adequately powered and randomized phase II trial of patients at risk for malignant infarction is needed to evaluate the potential efficacy of RP-1127.

Effectiveness of hydrogen rich water on antioxidant status of subjects with potential metabolic syndrome-an open label pilot study.

PubMed

Nakao, Atsunori; Toyoda, Yoshiya; Sharma, Prachi; Evans, Malkanthi; Guthrie, Najla

2010-03-01

Metabolic syndrome is characterized by cardiometabolic risk factors that include obesity, insulin resistance, hypertension and dyslipidemia. Oxidative stress is known to play a major role in the pathogenesis of metabolic syndrome. The objective of this study was to examine the effectiveness of hydrogen rich water (1.5-2 L/day) in an open label, 8-week study on 20 subjects with potential metabolic syndrome. Hydrogen rich water was produced, by placing a metallic magnesium stick into drinking water (hydrogen concentration; 0.55-0.65 mM), by the following chemical reaction; Mg + 2H(2)O --> Mg (OH)(2) + H(2). The consumption of hydrogen rich water for 8 weeks resulted in a 39% increase (p<0.05) in antioxidant enzyme superoxide dismutase (SOD) and a 43% decrease (p<0.05) in thiobarbituric acid reactive substances (TBARS) in urine. Further, subjects demonstrated an 8% increase in high density lipoprotein (HDL)-cholesterol and a 13% decrease in total cholesterol/HDL-cholesterol from baseline to week 4. There was no change in fasting glucose levels during the 8 week study. In conclusion, drinking hydrogen rich water represents a potentially novel therapeutic and preventive strategy for metabolic syndrome. The portable magnesium stick was a safe, easy and effective method of delivering hydrogen rich water for daily consumption by participants in the study.

In vivo fluorescence imaging of an orthotopic rat bladder tumor model indicates differential uptake of intravesically instilled near-infrared labeled 2-deoxyglucose analog by neoplastic urinary bladder tissues

NASA Astrophysics Data System (ADS)

Piao, Daqing; Davis, Carole A.; Hurst, Robert E.; Slaton, Joel W.

2017-02-01

Bladder cancer is one of the most expensive cancers to manage due to frequent recurrences requiring life-long surveillance and treatment. A near-infrared labeled 2-deoxy-d-glucose probe IRDye800CW-DG targeting glucose metabolism pathway has shown to enhance the sensitivity of diagnosing several types of cancers as tested on tumor models not including bladder tumor. This pilot study has explored differential uptake of intravesically administered IRDye800CW-DG in an orthotopic rat bladder tumor model. Twenty-five female Fischer rats were randomly grouped to four conditions: no-tumor-control (n=3), no-tumor-control intravesically instilled with IRDye800CWDG (n=6), rats bearing GFP-labeled AY-27 rat bladder urothelial cell carcinoma cells and washed with saline (n=5), and rats bearing AY-27 tumors and intravesically instilled with IRDye800CW-DG (n=11). Near-infrared fluorescence was measured from the opened bladder wall of anesthetized rat at an excitation wavelength of 750nm and an emission wavelength of 776nm, by using an in-house fluorescence imaging system. There is no statistically significant difference of the peak fluorescence intensity among the no-tumor-control bladders (n=3), the no-tumorcontrol bladders instilled with IRDye800CW-DG (n=6), and the GFP-labeled AY-27 treated bladders washed by saline (n=5). When compared to that of the no-tumor-control bladders instilled with IRDye800CW-DG (n=6), the fluorescence intensity of GFP-labeled AY-27 treated bladders instilled with IRDye800CW-DG and with histology confirmed neoplastic bladder tissue (n=11) was remarkably more intense (3.34 fold of over the former) and was also statistically significant (p<0.0001). The differential uptake of IRDye800CW-DG by the neoplastic urinary bladder tissues suggests the potential for cystoscopy-adaptation to enhance diagnosis and guiding surgical management of flat urinary bladder cancer.

Dexpanthenol enemas in ulcerative colitis: a pilot study.

PubMed

Loftus, E V; Tremaine, W J; Nelson, R A; Shoemaker, J D; Sandborn, W J; Phillips, S F; Hasan, Y

1997-07-01

To test the hypothesis that topical administration of pantothenic acid, a precursor of coenzyme A, might result in increased tissue levels of coenzyme A, improvement of fatty acid oxidation, and amelioration of ulcerative colitis. In an open-label pilot study, three patients with active left-sided ulcerative colitis received nightly enemas that contained 1,000 mg of dexpanthenol for 4 weeks. Before and after the study, patients submitted stool specimens for short-chain fatty acid analysis and urine collections for measurement of pantothenic acid and dicarboxylic acids; they also underwent flexible sigmoidoscopy for procurement of biopsy specimens for histologic examination and measurement of colonic coenzyme A activity. A clinical disease activity index and histologic disease activity index were used to assess response. Despite increases in urinary pantothenic acid, no significant changes were found in colonic tissue coenzyme A concentrations, fecal short-chain fatty acid concentrations, or urinary dicarboxylic acid concentrations. Moreover, no significant changes in clinical or histologic disease activity were noted. Although stool frequency and rectal bleeding remained unchanged, all patients noted increased abdominal cramping, and one patient had an increased extent of disease. Topically administered dexpanthenol seems to be absorbed, but at the dose used in this study, it did not influence concentrations of colonic coenzyme A activity, fecal short-chain fatty acids, or clinical response in patients with active left-sided ulcerative colitis.

Feasibility of a novel remote daily monitoring system for age-related macular degeneration using mobile handheld devices: results of a pilot study.

PubMed

Kaiser, Peter K; Wang, Yi-Zhong; He, Yu-Guang; Weisberger, Annemarie; Wolf, Stephane; Smith, Craig H

2013-10-01

This pilot study evaluated the feasibility of the Health Management Tool (HMT), a novel computing system using mobile handheld devices, to remotely monitor retinal visual function daily in patients with neovascular age-related macular degeneration treated with ranibizumab. Patients with neovascular age-related macular degeneration in at least 1 eye (newly diagnosed or successfully treated < 1 year) and eligible for ranibizumab therapy were enrolled in this 16-week, prospective, open-label, single-arm study. Patients performed a shape discrimination hyperacuity test (myVisionTrack [mVT]) daily on the HMT device (iPhone 3GS) remotely and at all clinic visits. Data entered into HMT devices were collected in the HMT database, which also sent reminders for patients to take mVT. Among 160 patients from 24 U.S. centers enrolled in the study (103 [64%] ≥ 75 years of age), 84.7% on average complied with daily mVT testing and ≈ 98.9% complied with at least weekly mVT testing. The HMT database successfully uploaded more than 17,000 mVT assessment values and sent more than 9,000 reminders. Elderly patients with neovascular age-related macular degeneration were willing and able to comply with daily self-testing of retinal visual function using mobile handheld devices in this novel system of remote vision monitoring.

Tracking of autologous adipose tissue-derived mesenchymal stromal cells with in vivo magnetic resonance imaging and histology after intralesional treatment of artificial equine tendon lesions--a pilot study.

PubMed

Geburek, Florian; Mundle, Kathrin; Conrad, Sabine; Hellige, Maren; Walliser, Ulrich; van Schie, Hans T M; van Weeren, René; Skutella, Thomas; Stadler, Peter M

2016-02-01

Adipose tissue-derived mesenchymal stromal cells (AT-MSCs) are frequently used to treat equine tendinopathies. Up to now, knowledge about the fate of autologous AT-MSCs after intralesional injection into equine superficial digital flexor tendons (SDFTs) is very limited. The purpose of this study was to monitor the presence of intralesionally injected autologous AT-MSCs labelled with superparamagnetic iron oxide (SPIO) nanoparticles and green fluorescent protein (GFP) over a staggered period of 3 to 9 weeks with standing magnetic resonance imaging (MRI) and histology. Four adult warmblood horses received a unilateral injection of 10 × 10(6) autologous AT-MSCs into surgically created front-limb SDFT lesions. Administered AT-MSCs expressed lentivirally transduced reporter genes for GFP and were co-labelled with SPIO particles in three horses. The presence of AT-MSCs in SDFTs was evaluated by repeated examinations with standing low-field MRI in two horses and post-mortem in all horses with Prussian blue staining, fluorescence microscopy and with immunofluorescence and immunohistochemistry using anti-GFP antibodies at 3, 5, 7 and 9 weeks after treatment. AT-MSCs labelled with SPIO particles were detectable in treated SDFTs during each MRI in T2*- and T1-weighted sequences until the end of the observation period. Post-mortem examinations revealed that all treated tendons contained high numbers of SPIO- and GFP-labelled cells. Standing low-field MRI has the potential to track SPIO-labelled AT-MSCs successfully. Histology, fluorescence microscopy, immunofluorescence and immunohistochemistry are efficient tools to detect labelled AT-MSCs after intralesional injection into surgically created equine SDFT lesions. Intralesional injection of 10 × 10(6) AT-MSCs leads to the presence of high numbers of AT-MSCs in and around surgically created tendon lesions for up to 9 weeks. Integration of injected AT-MSCs into healing tendon tissue is an essential pathway after intralesional administration. Injection techniques have to be chosen deliberately to avoid reflux of the cell substrate injected. In vivo low-field MRI may be used as a non-invasive tool to monitor homing and engraftment of AT-MSCs in horses with tendinopathy of the SDFT.

The effect of increasing the dose of hydroxychloroquine (HCQ) in patients with refractory cutaneous lupus erythematosus (CLE): An open-label prospective pilot study.

PubMed

Chasset, François; Arnaud, Laurent; Costedoat-Chalumeau, Nathalie; Zahr, Noel; Bessis, Didier; Francès, Camille

2016-04-01

Up to 30% of patients with cutaneous lupus erythematosus (CLE) fail to respond to hydroxychloroquine (HCQ). We sought to evaluate the efficacy of increased daily doses of HCQ on cutaneous response in refractory CLE. We conducted an open-label prospective study between 2010 and 2014. Patients with CLE and HCQ blood level less than or equal to 750 ng/mL were included. The daily dose of HCQ was increased to reach blood concentrations greater than 750 ng/mL. The primary end point was the number of responders defined by an improvement of CLE Disease Area and Severity Index score (4 points or 20% decrease) in patients with HCQ blood concentration greater than 750 ng/mL. We included 34 patients (26 women; median age 45 [range 28-72] years). Two nonadherent patients were excluded. The median CLE Disease Area and Severity Index score before treatment was significantly improved after treatment (8 [range 2-30] vs 1.5 [range 0-30]), P < .001). The primary response criterion was reached in 26 (81%) of the 32 patients analyzed. A decrease in HCQ doses without further CLE flare (median follow-up 15.8 [range 3.06-77.4] months) was achieved in 15 of the 26 responders. The main limitations of the study are its open-label design and the limited number of patients included. Increasing HCQ doses to reach blood concentrations greater than 750 ng/mL should be considered before addition of other treatments in refractory CLE. Copyright © 2015 American Academy of Dermatology, Inc. Published by 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.

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.

[The 18F-FDG myocardial metabolic imaging in twenty seven pilots with regular aerobic training].

PubMed

Fang, Ting-Zheng; Zhu, Jia-Rui; Chuan, Ling; Zhao, Wen-Rui; Xu, Gen-Xiang; Yang, Min-Fu; He, Zuo-Xiang

2009-02-01

To evaluate the characteristics of myocardial (18)F-FDG imaging in pilots with regular aerobic exercise training. Twenty seven healthy male pilots with regular aerobic exercise training were included in this study. The subjects were divided into fasting (n = 17) or non-fasting group (n = 10). Fluorine-18-labeled deoxyglucose and Tc-99m-sestamibi dual-nuclide myocardial imaging were obtained at rest and at target heart rate during bicycle ergometer test. The exercise and rest myocardial perfusion imaging were analyzed for myocardial ischemia presence. The myocardial metabolism imaging was analyzed with the visual semi-quantitative analyses model of seventeen segments. The secondary-extreme heart rate (195-age) was achieved in all subjects. There was no myocardial ischemia in all perfusion imaging. In the visual qualitative analyses, four myocardial metabolism imaging failed in the fasting group while one failed in the non-fasting group (P > 0.05). In the visual semi-quantitative analyses, myocardial metabolism imaging scores at rest or exercise in all segments were similar between two groups (P > 0.05). In the fasting group, the myocardial metabolism imaging scores during exercise were significantly higher than those at rest in 6 segments (P < 0.05). In the non-fasting group, the scores of 3 exercise myocardial metabolism imaging were significantly higher than those at rest (P < 0.05). Satisfactory high-quality myocardial metabolism imaging could be obtained at fasting and exercise situations in subjects with regular aerobic exercise.

A pilot-study of hypnotherapy as complementary treatment for pain in chronic pancreatitis.

PubMed

Juel, Jacob; Abrahamsen, Randi; Olesen, Søren S; Drewes, Asbjørn M

2018-05-10

BackgroundChronic pain is the hallmark symptom of chronic pancreatitis (CP). Its treatment is complicated, and often the patients have side-effects notwithstanding that pain is not ameliorated in many cases. Hypnotherapy has been shown to improve symptoms of irritable bowel syndrome including abdominal pain and, as such, may serve as a remedy to relive pain. The aim of this open-label pilot-study was to test the effect of hypnotherapy for pain in patients with CP. MethodsFour patients with CP and chronic abdominal pain were included and followed for four consecutive weeks. The primary efficacy parameter was pain relief. After 1 week of baseline patients received a 1-h session of hypnotherapy. This was repeated at day 15 and day 23 and supplemented by self-administered hypnotherapy. ResultsThree of four participants completed the trial and experienced short lasting pain reduction during the trial. The reported pain relief was in the range of 20%-39% compared to baseline. Hypnotherapy improved self-reported sleep, vitality, and social life. ConclusionsThe results suggest that hypnotherapy may reduce pain related to CP. Furthermore, no adverse effects were reported and the majority of participants completed the trial. Further prospective controlled trials are warranted to examine the potential of hypnotherapy.

Evolutionary Engineering in Chemostat Cultures for Improved Maltotriose Fermentation Kinetics in Saccharomyces pastorianus Lager Brewing Yeast

PubMed Central

Brickwedde, Anja; van den Broek, Marcel; Geertman, Jan-Maarten A.; Magalhães, Frederico; Kuijpers, Niels G. A.; Gibson, Brian; Pronk, Jack T.; Daran, Jean-Marc G.

2017-01-01

The lager brewing yeast Saccharomyces pastorianus, an interspecies hybrid of S. eubayanus and S. cerevisiae, ferments maltotriose, maltose, sucrose, glucose and fructose in wort to ethanol and carbon dioxide. Complete and timely conversion (“attenuation”) of maltotriose by industrial S. pastorianus strains is a key requirement for process intensification. This study explores a new evolutionary engineering strategy for improving maltotriose fermentation kinetics. Prolonged carbon-limited, anaerobic chemostat cultivation of the reference strain S. pastorianus CBS1483 on a maltotriose-enriched sugar mixture was used to select for spontaneous mutants with improved affinity for maltotriose. Evolved populations exhibited an up to 5-fold lower residual maltotriose concentration and a higher ethanol concentration than the parental strain. Uptake studies with 14C-labeled sugars revealed an up to 4.75-fold higher transport capacity for maltotriose in evolved strains. In laboratory batch cultures on wort, evolved strains showed improved attenuation and higher ethanol concentrations. These improvements were also observed in pilot fermentations at 1,000-L scale with high-gravity wort. Although the evolved strain exhibited multiple chromosomal copy number changes, analysis of beer made from pilot fermentations showed no negative effects on flavor compound profiles. These results demonstrate the potential of evolutionary engineering for strain improvement of hybrid, alloploid brewing strains. PMID:28943864

Evolutionary Engineering in Chemostat Cultures for Improved Maltotriose Fermentation Kinetics in Saccharomyces pastorianus Lager Brewing Yeast.

PubMed

Brickwedde, Anja; van den Broek, Marcel; Geertman, Jan-Maarten A; Magalhães, Frederico; Kuijpers, Niels G A; Gibson, Brian; Pronk, Jack T; Daran, Jean-Marc G

2017-01-01

The lager brewing yeast Saccharomyces pastorianus , an interspecies hybrid of S. eubayanus and S. cerevisiae , ferments maltotriose, maltose, sucrose, glucose and fructose in wort to ethanol and carbon dioxide. Complete and timely conversion ("attenuation") of maltotriose by industrial S. pastorianus strains is a key requirement for process intensification. This study explores a new evolutionary engineering strategy for improving maltotriose fermentation kinetics. Prolonged carbon-limited, anaerobic chemostat cultivation of the reference strain S. pastorianus CBS1483 on a maltotriose-enriched sugar mixture was used to select for spontaneous mutants with improved affinity for maltotriose. Evolved populations exhibited an up to 5-fold lower residual maltotriose concentration and a higher ethanol concentration than the parental strain. Uptake studies with 14 C-labeled sugars revealed an up to 4.75-fold higher transport capacity for maltotriose in evolved strains. In laboratory batch cultures on wort, evolved strains showed improved attenuation and higher ethanol concentrations. These improvements were also observed in pilot fermentations at 1,000-L scale with high-gravity wort. Although the evolved strain exhibited multiple chromosomal copy number changes, analysis of beer made from pilot fermentations showed no negative effects on flavor compound profiles. These results demonstrate the potential of evolutionary engineering for strain improvement of hybrid, alloploid brewing strains.

Effects of rivastigmine on visual attention in subjects with amnestic mild cognitive impairment: A serial functional MRI activation pilot-study.

PubMed

Bokde, Arun L W; Cavedo, Enrica; Lopez-Bayo, Patricia; Lista, Simone; Meindl, Thomas; Born, Christine; Galluzzi, Samantha; Faltraco, Frank; Dubois, Bruno; Teipel, Stefan J; Reiser, Maximilian; Möller, Hans-Jürgen; Hampel, Harald

2016-03-30

A pilot study to investigate the effects of rivastigmine on the brain activation pattern due to visual attention tasks in a group of amnestic Mild Cognitive Impaired patients (aMCI). The design was an initial three-month double blind period with a rivastigmine and placebo arms, followed by a nine-month open-label period. All patients underwent serial functional magnetic resonance imaging (fMRI) at baseline, and after three and six months of follow-up. Primary endpoint was the effect of rivastigmine on functional brain changes during visual attention (face and location matching) tasks. There were five in the rivastigmine arm and two in the placebo arm. The face matching task showed higher activation of visual areas after three months of treatment but no differences compared to baseline at six months. The location matching task showed a higher activation along the dorsal visual pathway at both three and six months follow ups. Treatment with rivastigmine demonstrates a significant effect on brain activation of the dorsal visual pathway during a location matching task in patients with aMCI. Our data support the potential use of task fMRI to map specific treatment effects of cholinergic drugs during prodromal stages of Alzheimer's disease (AD). Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

IceTrendr: a linear time-series approach to monitoring glacier environments using Landsat

NASA Astrophysics Data System (ADS)

Nelson, P.; Kennedy, R. E.; Nolin, A. W.; Hughes, J. M.; Braaten, J.

2017-12-01

Arctic glaciers in Alaska and Canada have experienced some of the greatest ice mass loss of any region in recent decades. A challenge to understanding these changing ecosystems, however, is developing globally-consistent, multi-decadal monitoring of glacier ice. We present a toolset and approach that captures, labels, and maps glacier change for use in climate science, hydrology, and Earth science education using Landsat Time Series (LTS). The core step is "temporal segmentation," wherein a yearly LTS is cleaned using pre-processing steps, converted to a snow/ice index, and then simplified into the salient shape of the change trajectory ("temporal signature") using linear segmentation. Such signatures can be characterized as simple `stable' or `transition of glacier ice to rock' to more complex multi-year changes like `transition of glacier ice to debris-covered glacier ice to open water to bare rock to vegetation'. This pilot study demonstrates the potential for interactively mapping, visualizing, and labeling glacier changes. What is truly innovative is that IceTrendr not only maps the changes but also uses expert knowledge to label the changes and such labels can be applied to other glaciers exhibiting statistically similar temporal signatures. Our key findings are that the IceTrendr concept and software can provide important functionality for glaciologists and educators interested in studying glacier changes during the Landsat TM timeframe (1984-present). Issues of concern with using dense Landsat time-series approaches for glacier monitoring include many missing images during the period 1984-1995 and that automated cloud mask are challenged and require the user to manually identify cloud-free images. IceTrendr is much more than just a simple "then and now" approach to glacier mapping. This process is a means of integrating the power of computing, remote sensing, and expert knowledge to "tell the story" of glacier changes.

Open-label study evaluating outpatient urethral sphincter injections of onabotulinumtoxinA to treat women with urinary retention due to a primary disorder of sphincter relaxation (Fowler's syndrome).

PubMed

Panicker, Jalesh N; Seth, Jai H; Khan, Shahid; Gonzales, Gwen; Haslam, Collette; Kessler, Thomas M; Fowler, Clare J

2016-05-01

To assess the efficacy (defined as improvements in maximum urinary flow rate [Qmax ] of ≥50%, post-void residual urine volume [PVR] and scores on the International Prostate Symptom Score [IPSS] questionnaire) and safety of urethral sphincter injections of onabotulinumtoxinA in women with a primary disorder of urethral sphincter relaxation, characterised by an elevated urethral pressure profile (UPP) and specific findings at urethral sphincter electromyography (EMG), i.e. Fowler's syndrome. In this open-label pilot Institutional Review Board-approved study, 10 women with a primary disorder of urethral sphincter relaxation (elevated UPP, sphincter volume, and abnormal EMG) presenting with obstructed voiding (five) or in complete urinary retention (five) were recruited from a single tertiary referral centre. Baseline symptoms were assessed using the IPSS, and Qmax and PVR were measured. After 2% lidocaine injection, 100 U of onabotulinumtoxinA was injected into the striated urethral sphincter, divided on either side, under EMG guidance. Patients were reviewed at 1, 4 and 10 weeks after injection, and assessed using the IPSS, Qmax and PVR measurements. The UPP was repeated at week 4. The mean (range) patient age was 40 (25-65) years, and the mean symptom scores on the IPSS improved from 25.6 to 14.1, and the mean 'bother' score reduced from 6.1 to 3.5 at week 10. As compared with a baseline mean Qmax of 8.12 mL/s in the women who could void, the Qmax improved to 15.8 mL/s at week 10. Four of the five women in complete retention could void spontaneously, with a mean Qmax of 14.3 mL/s at week 10. The mean PVR decreased from 260 to 89 mL and the mean static UPP improved from 113 cmH2 O at baseline to 90 cmH2 O. No serious side-effects were reported. Three women with a history of recurrent urinary tract infections developed a urinary tract infection. There were no reports of stress urinary incontinence. Seven of the 10 women opted to return for repeat injections. This pilot study shows an improvement in patient-reported lower urinary tract symptoms, and the objective parameters of Qmax , PVR and UPP, at 10 weeks after urethral sphincter injections of onabotulinumtoxinA. No serious side-effects were reported. This treatment could represent a safe outpatient treatment for young women in retention due to a primary disorder of urethral sphincter relaxation. However, a larger study is required to confirm the findings of this pilot study. © 2015 The Authors BJU International © 2015 BJU International Published by John Wiley & Sons Ltd.

Pilot trials with a fluorescent whitening agent of the bis(triazoly) stilbene-disulfonic acid type in golden orfes.

PubMed

Hamburger, B; Maul, W; Patzschke, K; Theidel, H; Wegner, L A

1975-01-01

Golden orfes were examined for uptake, distribution, and elimination of radioactivity administered in the form of a 14C-labelled fluorescent whitening agent (FWA) of the bis(triazolyl)stilbenedisulfonic acid type. Results of these studies are given below. Pilot trials using FWA concentrations of 10 and 100 ppb and a population density of 1 fish per liter show that an equilibrium between uptake and elimination of the FWA develops in the animals within a period of one week; i.e., the incorporated traces of the FWA are not irreversibly bound. The radioactivity is mainly located in the gall bladder and in the intestinal contents, as well as in the liver, throat, and gills. The muscular system (filet) is virtually free from activity. Approximately 1-2% of the FWA amount administered per animal (corresponding to the concentration factors of 7-14) can be temporarily detected in the fish. Radioactivity is eliminated comparatively quickly. Two days following the transfer of the fish into water free from FWA a concentration factor as low as 1 is reached, i.e. from this time the FWA concentration in the animals decreases to less than 10 resp. 100 ppb.

Enhancing physical activity and reducing obesity through smartcare and financial incentives: A pilot randomized trial.

PubMed

Shin, Dong Wook; Yun, Jae Moon; Shin, Jung-Hyun; Kwon, Hyuktae; Min, Hye Yeon; Joh, Hee-Kyung; Chung, Won Joo; Park, Jin Ho; Jung, Kee-Taig; Cho, BeLong

2017-02-01

A pilot randomized trial assessed the feasibility and effectiveness of an intervention combining Smartcare (activity tracker with a smartphone application) and financial incentives. A three-arm, open-label randomized controlled trial design involving traditional education, Smartcare, and Smartcare with financial incentives was involved in this study. The latter group received financial incentives depending on the achievement of daily physical activity goals (process incentive) and weight loss targets (outcome incentive). Male university students (N = 105) with body mass index of ≥27 were enrolled. The average weight loss in the traditional education, Smartcare, and Smartcare with financial incentives groups was -0.4, -1.1, and -3.1 kg, respectively, with significantly greater weight loss in the third group (both Ps < 0.01). The final weight loss goal was achieved by 0, 2, and 10 participants in the traditional education, Smartcare, and Smartcare with financial incentives groups (odds ratio for the Smartcare with financial incentive vs. Smartcare = 7.27, 95% confidence interval: 1.45-36.47). Levels of physical activity were significantly higher in this group. The addition of financial incentives to Smartcare was effective in increasing physical activity and reducing obesity. © 2017 The Obesity Society.

Clinical Validation of Therapeutic Drug Monitoring of Imipenem in Spent Effluent in Critically Ill Patients Receiving Continuous Renal Replacement Therapy: A Pilot Study

PubMed Central

Wen, Aiping; Li, Zhe; Yu, Junxian; Li, Ren; Cheng, Sheng; Duan, Meili; Bai, Jing

2016-01-01

Objectives The primary objective of this pilot study was to investigate whether the therapeutic drug monitoring of imipenem could be performed with spent effluent instead of blood sampling collected from critically ill patients under continuous renal replacement therapy. Methods A prospective open-label study was conducted in a real clinical setting. Both blood and effluent samples were collected pairwise before imipenem administration and 0.5, 1, 1.5, 2, 3, 4, 6, and 8 h after imipenem administration. Plasma and effluent imipenem concentrations were determined by reversed-phase high-performance liquid chromatography with ultraviolet detection. Pharmacokinetic and pharmacodynamic parameters of blood and effluent samples were calculated. Results Eighty-three paired plasma and effluent samples were obtained from 10 patients. The Pearson correlation coefficient of the imipenem concentrations in plasma and effluent was 0.950 (P<0.0001). The average plasma-to-effluent imipenem concentration ratio was 1.044 (95% confidence interval, 0.975 to 1.114) with Bland-Altman analysis. No statistically significant difference was found in the pharmacokinetic and pharmacodynamic parameters tested in paired plasma and effluent samples with Wilcoxon test. Conclusion Spent effluent of continuous renal replacement therapy could be used for therapeutic drug monitoring of imipenem instead of blood sampling in critically ill patients. PMID:27093294

Efficacy of Atopy Patch Testing in Directed Dietary Therapy of Eosinophilic Esophagitis: A Pilot Study.

PubMed

Eckmann, Jason D; Ravi, Karthik; Katzka, David A; Davis, Dawn R; See, Jacalyn A; Geno, Debra R; Kryzer, Lori A; Alexander, Jeffrey A

2018-03-01

Atopy patch testing (APT) has shown potential for predicting dietary food triggers in studies of children and adolescents with eosinophilic esophagitis (EoE). To assess the efficacy of APT in adults with EoE. We conducted a prospective open-label pilot study of patients ≥ 18 years old with diagnosis of EoE at Mayo Clinic in Rochester, Minnesota, from November 2014 to January 2016. All patients underwent patch testing using intact food products, followed by a six food elimination diet and stepwise food reintroduction. Response to elimination diet was assessed with serial endoscopy with biopsies as well as clinical symptoms. APT results were directly compared to elimination diet results for assessment of efficacy. Correlation between clinical symptoms, endoscopic score, and histology was also qualitatively evaluated. Fifty percent of the patients had a positive APT, while only 16% had an APT result confirmed histologically during food reintroduction. Sensitivity of APT was calculated to be 5.9%, with specificity of 92.0%. Furthermore, we found significant qualitative inter-patient heterogeneity in the correlation between clinical symptoms, EREFS score, and histology. APT does not reliably predict food triggers identified by food elimination diet in adult patients with EoE. As a result, APT does not have a clear role in the evaluation of patients with EoE.

Does adding an emotion component enhance the Triple P-Positive Parenting Program?

PubMed

Salmon, Karen; Dittman, Cassandra; Sanders, Matthew; Burson, Rebecca; Hammington, Josie

2014-04-01

This pilot study aimed to compare the efficacy of a regular offering of the group-delivered Triple P-Positive Parenting Program for child behavior problems with an enhanced version tailored to promote child emotion competence. Families of children between ages 3 and 6 years displaying early-onset conduct problems were randomly assigned to Group Triple P (GTP; final n = 18) or Emotion Enhanced Triple P (EETP; final n = 18), in which parents were encouraged to incorporate emotion labels and causes and to coach emotion competence during discussions of everyday emotional experiences with their child. Compared with parents who received GTP, parents who received EETP increased their discussion of emotion labels and emotion causes in conversations with their child at postintervention, but this advantage was lost by the 4-month follow-up. Parents in the EETP condition also used more emotion coaching postintervention and at follow-up. There were no differences at postintervention or follow-up in children's emotion knowledge skills. Postintervention improvement in disruptive child behavior was greater for GTP, but the groups converged at follow-up. Parents were similarly satisfied with both interventions. Overall, EETP showed little advantage over regular GTP delivery. PsycINFO Database Record (c) 2014 APA, all rights reserved.

Antihypertensive effect of barnidipine 10 mg or amlodipine 5 to 10 mg once daily in treatment-naive patients with essential hypertension: A 24-week, randomized, open-label, pilot study

PubMed Central

Rossetti, Giuseppe; Pizzocri, Samuele; Brasca, Francesco; Pozzi, Marta; Beltrami, Laura M.; Bolla, Giovanni B.; Famiani, Roberta; Caimi, Barbara; Omboni, Stefano; Magrini, Fabio; Carugo, Stefano

2008-01-01

Background: Dihydropyridine calcium antagonists are largely employed for the treatment of hypertension, coronary heart disease, and heart failure. Objective: The aim of our study was to compare the antihypertensive effect of the dihydropyridine calcium antagonists barnidipine and amlodipine. Methods: This was a 24-week, randomized, open-label, pilot study. Consecutive treatment-naive patients with grade I or II essential hypertension (office sitting systolic blood pressure [BP] of 140–179 mm Hg and diastolic BP of 90–109 mm Hg) were enrolled. The primary end points were the effect of treatment with either barnidipine 10 mg or amlodipine 5 mg once daily on office and ambulatory BP, left ventricular mass index (LVMI), and markers of cardiac damage, serum procollagen type I C-terminal propeptide, and plasma amino-terminal pro-B-type natriuretic peptide concentrations. Patients were assessed at enrollment, and 12 and 24 weeks. During each visit, the prevalence of adverse events (AEs) was also monitored using spontaneous reporting, patient interview, and physical examination, the relationship to study drug being determined by the investigators. Compliance with treatment was assessed at each study visit by counting returned tablets. Results: Thirty eligible patients (20 men, 10 women; mean [SD] age, 47 [12] years) were included in the study; all patients completed the 24 weeks of study treatment. Twelve weeks after randomization, 6 patients in the amlodipine group had their dose doubled to 10 mg due to inadequate BP control. Mean BP reductions at study end were not significantly different between the barnidipine and amlodipine groups (office BP, −10.3/−9.4 vs −16.6/−9.1 mm Hg; ambulatory BP, 9.4/6.4 vs 8.1/5.1 mm Hg). Reductions in LVMI and markers of cardiac damage were not significantly different between the 2 groups. Significantly more patients in the amlodipine group reported drug-related AEs compared with those in the barnidipine group (9 [60%] vs 2 [13%]; P < 0.05). Conclusion: In this small sample of treatment-naive hypertensive patients, the antihypertensive effect of barnidipine 10 mg once daily was not significantly different from that of amlodipine 5 to 10 mg once daily. PMID:24692798

Disseminating Childhood Home Injury Risk Reduction Information in Pakistan: Results from a Community-Based Pilot Study

PubMed Central

Chandran, Aruna; Khan, Uzma Rahim; Zia, Nukhba; Feroze, Asher; de Ramirez, Sarah Stewart; Huang, Cheng-Ming; Razzak, Junaid A.; Hyder, Adnan A.

2013-01-01

Background: Most childhood unintentional injuries occur in the home; however, very little home injury prevention information is tailored to developing countries. Utilizing our previously developed information dissemination tools and a hazard assessment checklist tailored to a low-income neighborhood in Pakistan, we pilot tested and compared the effectiveness of two dissemination tools. Methods: Two low-income neighborhoods were mapped, identifying families with a child aged between 12 and 59 months. In June and July 2010, all enrolled households underwent a home hazard assessment at the same time hazard reduction education was being given using an in-home tutorial or a pamphlet. A follow up assessment was conducted 4–5 months later. Results: 503 households were enrolled; 256 received a tutorial and 247 a pamphlet. The two groups differed significantly (p < 0.01) in level of maternal education and relationship of the child to the primary caregiver. However, when controlling for these variables, those receiving an in-home tutorial had a higher odds of hazard reduction than the pamphlet group for uncovered vats of water (OR 2.14, 95% CI: 1.28, 3.58), an open fire within reach of the child (OR 3.55, 95% CI: 1.80, 7.00), and inappropriately labeled cooking fuel containers (OR 1.86, 95% CI: 1.07, 3.25). Conclusions: This pilot project demonstrates the potential utility of using home-visit tutorials to decrease home hazards in a low-income neighborhood in Pakistan. A longer-term randomized study is needed to assess actual effectiveness of the use of allied health workers for home-based injury education and whether this results in decreased home injuries. PMID:23502323

Effects of dual-task balance training on postural performance in patients with Multiple Sclerosis: a double-blind, randomized controlled pilot trial.

PubMed

Monjezi, Saeideh; Negahban, Hossein; Tajali, Shirin; Yadollahpour, Nava; Majdinasab, Nastaran

2017-02-01

To investigate the effects of dual-task balance training on postural performance in patients with multiple sclerosis as compared with single-task balance training. Double-blind, pretest-posttest, randomized controlled pilot trial. Local Multiple Sclerosis Society. A total of 47 patients were randomly assigned to two equal groups labeled as single-task training and dual-task training groups. All patients received supervised balance training sessions, 3 times per week for 4 weeks. The patients in the single-task group performed balance activities, alone. However, patients in dual-task group practiced balance activities while simultaneously performing cognitive tasks. The 10-Meter Walk Test and Timed Up-and-Go under single-task and dual-task conditions, in addition to Activities-specific Balance Confidence, Berg Balance Scale, and Functional Gait Assessment were assessed pre-, and post intervention and also 6-weeks after the end of intervention. Only 38 patients completed the treatment plan. There was no difference in the amount of improvement seen between the two study groups. In both groups there was a significant effect of time for dual-10 Meter Walk Test (F 1, 36 =11.33, p=0.002) and dual-Timed Up-and-Go (F 1, 36 =14.27, p=0.001) but not for their single-tasks. Moreover, there was a significant effect of time for Activities-specific Balance Confidence, Berg Balance Scale, and Functional Gait Assessment ( P<0.01). This pilot study did not show more benefits from undertaking dual-task training than single-task training. A power analysis showed 71 patients per group would be needed to determine whether there was a clinically relevant difference for dual-task gait speed between the groups.

Commercial conspiracy theories: a pilot study

PubMed Central

Furnham, Adrian

2013-01-01

There are many ways to categorise conspiracy theories. In the present study, we examined individual and demographic predictors of beliefs in commercial conspiracy theories among a British sample of over 300 women and men. Results showed many people were cynical and sceptical with regard to advertising tricks, as well as the tactics of organisations like banks and alcohol, drug and tobacco companies. Beliefs sorted into four identifiable clusters, labelled sneakiness, manipulative, change-the-rules and suppression/prevention. The high alpha for the overall scale suggested general beliefs in commercial conspiracy. Regressions suggested that those people who were less religious, more left-wing, more pessimistic, less (self-defined as) wealthy, less Neurotic and less Open-to-Experience believed there was more commercial conspiracy. Overall the individual difference variables explained relatively little of the variance in these beliefs. The implications of these findings for the literature on conspiracy theories are discussed. Limitations of the study are also discussed. PMID:23818886

Label-free characterization of articular cartilage in osteoarthritis model mice by Raman spectroscopy

NASA Astrophysics Data System (ADS)

Oshima, Yusuke; Akehi, Mayu; Kiyomatsu, Hiroshi; Miura, Hiromasa

2017-02-01

Osteoarthritis (OA) is very common joint disease in the aging population. Main symptom of OA is accompanied by degenerative changes of articular cartilage. Cartilage contains mostly type II collagen and proteoglycans, so it is difficult to access the quality and morphology of cartilage tissue in situ by conventional diagnostic tools (X-ray, MRI and echography) directly or indirectly. Raman spectroscopy is a label-free technique which enables to analyze molecular composition in degenerative cartilage. In this study, we generated an animal OA model surgically induced by knee joint instability, and the femurs were harvested at two weeks after the surgery. We performed Raman spectroscopic analysis for the articular cartilage of distal femurs in OA side and unaffected side in each mouse. In the result, there is no gross findings in the surface of the articular cartilage in OA. On the other hand, Raman spectral data of the articular cartilage showed drastic changes in comparison between OA and control side. The major finding of this study is that the relative intensity of phosphate band (960 cm-1) increases in the degenerative cartilage. This may be the result of exposure of subchondral bone due to thinning of the cartilage layer. In conclusion, Raman spectroscopic technique is sufficient to characterize articular cartilage in OA as a pilot study for Raman application in cartilage degeneration and regeneration using animal models and human subjects.

Towards objective and reproducible study of patient-doctor interaction: Automatic text analysis based VR-CoDES annotation of consultation transcripts.

PubMed

Birkett, Charlotte; Arandjelovic, Ognjen; Humphris, Gerald

2017-07-01

While increasingly appreciated for its importance, the interaction between health care professionals (HCP) and patients is notoriously difficult to study, with both methodological and practical challenges. The former has been addressed by the so-called Verona coding definitions of emotional sequences (VR-CoDES) - a system for identifying and coding patient emotions and the corresponding HCP responses - shown to be reliable and informative in a number of independent studies in different health care delivery contexts. In the preset work we focus on the practical challenge of the scalability of this coding system, namely on making it easily usable more widely and on applying it on larger patient cohorts. In particular, VR-CoDES is inherently complex and training is required to ensure consistent annotation of audio recordings or textual transcripts of consultations. Following up on our previous pilot investigation, in the the present paper we describe the first automatic, computer based algorithm capable of providing coarse level coding of textual transcripts. We investigate different representations of patient utterances and classification methodologies, and label each utterance as either containing an explicit expression of emotional distress (a `concern'), an implicit one (a `cue'), or neither. Using a data corpus comprising 200 consultations between radiotherapists and adult female breast cancer patients we demonstrate excellent labelling performance.

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.

Sage tea-thyme-peppermint hydrosol oral rinse reduces chemotherapy-induced oral mucositis: A randomized controlled pilot study.

PubMed

Mutluay Yayla, Ezgi; Izgu, Nur; Ozdemir, Leyla; Aslan Erdem, Sinem; Kartal, Murat

2016-08-01

This pilot study aimed to investigate the preventive effect of sage tea-thyme-peppermint hydrosol oral rinse used in conjunction with basic oral care on chemotherapy-induced oral mucositis. An open-label randomized controlled study. Two oncology hospitals in Ankara, Turkey. Patients receiving 5-fluorouracil-based chemotherapy regimens were divided into the intervention group (N=30) and control group (N=30). Basic oral care was prescribed to the control group, while the intervention group was prescribed sage tea-thyme-peppermint hydrosol in addition to basic oral care. All patients were called to assess their compliance with the study instructions on day 5 and 14. Oral mucositis was evaluated using an inspection method or by assessing oral cavity photos based on the World Health Organization oral toxicity scale on day 5 and 14. Most of the patients in the intervention group did not develop oral mucositis on day 5. In addition, the incidence of grade 1 oral mucositis was statistically lower in the intervention group (10%) than the control group (53.3%) on day 5. By day 14, the majority of patients in both the groups had grade 0 oral mucositis. Sage tea-thyme-peppermint hydrosol oral rinse has promising results in alleviating oral mucositis. This hydrosol can be recommended for clinical use as it is well tolerated and cost-effective. However, further randomized controlled trials are needed to support the study. Copyright © 2016 Elsevier Ltd. All rights reserved.

Efficacy of chess training for the treatment of ADHD: A prospective, open label study.

PubMed

Blasco-Fontecilla, Hilario; Gonzalez-Perez, Marisa; Garcia-Lopez, Raquel; Poza-Cano, Belen; Perez-Moreno, Maria Rosario; de Leon-Martinez, Victoria; Otero-Perez, Jose

2016-01-01

To examine the effectiveness of playing chess as a treatment option for children with ADHD. Parents of 44 children ages 6 to 17 with a primary diagnosis of ADHD consented to take part in the study. Parents completed the Spanish version of the Swanson, Nolan and Pelham Scale for parents (SNAP-IV) and the Abbreviated Conner's Rating Scales for parents (CPRS-HI) prior to an 11-week chess-training program. We used a paired t-test to compare pre- and post-intervention outcomes, and Cohen-d calculations to measure the magnitude of the effect. The statistical significance was set at P<.05. Children with ADHD improved in both the SNAP-IV (t=6.23; degrees of freedom (df)=41; P<.001) and the CPRS-HI (t=5.39; df=33; P<.001). Our results suggest a large effect in decreasing the severity of ADHD as measured by the SNAP-IV (d=0.85) and the CPRS-HI (d=0.85). Furthermore, we found a correlation between intelligence quotient and SNAP-IV improvement (P<.05). The results of our pilot study should be interpreted with caution. This pilot project highlights the importance of carrying out larger studies with a case-control design. If our results are replicated in better designed studies, playing chess could be included within the multimodal treatment of ADHD. Copyright © 2014 SEP y SEPB. Published by Elsevier España. All rights reserved.

Reduction of fatigue in Sjögren syndrome with rituximab: results of a randomised, double-blind, placebo-controlled pilot study.

PubMed

Dass, S; Bowman, S J; Vital, E M; Ikeda, K; Pease, C T; Hamburger, J; Richards, A; Rauz, S; Emery, P

2008-11-01

Primary Sjögren syndrome (pSS) causes significant systemic symptoms including fatigue as well as glandular dysfunction. There are currently no effective systemic therapies; however, open label series have suggested that rituximab may be beneficial for systemic and glandular manifestations. Therefore, we performed a double blind, placebo-controlled, randomised pilot study of the efficacy of rituximab in reducing fatigue in pSS. A total of 17 patients with pSS and a score on fatigue visual analogue scale (VAS) >50 were randomised to receive either 2 infusions of rituximab 1 g or placebo; patients also received oral and intravenous steroids. Outcome measures included: the proportion of patients with >20% reduction in fatigue VAS, changes in pSS related symptoms, health related quality of life and immunological parameters of pSS. These were measured 6 months after therapy. There was significant improvement from baseline in fatigue VAS in the rituximab group (p<0.001) in contrast to the placebo group (p = 0.147). There was a significant difference between the groups at 6 months in the social functioning score of SF-36 (p = 0.01) and a trend to significant difference in the mental health domain score of SF-36 (p = 0.06). There was one episode of serum sickness in the rituximab treated group. This is the first double blind study of rituximab in pSS to show benefit; further studies are justified.

Cell Uptake and Validation of Novel PECs for Biomedical Applications.

PubMed

Palamà, Ilaria E; Musarò, Mariarosaria; Coluccia, Addolorata M L; D'Amone, Stefania; Gigli, Giuseppe

2011-01-01

This pilot study provides the proof of principle for biomedical application of novel polyelectrolyte complexes (PECs) obtained via electrostatic interactions between dextran sulphate (DXS) and poly(allylamine hydrochloride) (PAH). Scanning electron microscopy (SEM) and atomic force microscopy (AFM) showed that DXS/PAH polyelectrolyte complexes were Monodispersed with regular rounded-shape features and average diameters of 250 nm at 2 : 1 weight ratios of DXS/PAH. Fluorescently labelled DXS and fluorescein-isothiocyanate- (FITC-)conjugate DXS were used to follow cell uptake efficiency of PECs and biodegradability of their enzymatically degradable DXS-layers by using confocal laser scanning microscopy (CLSM). Moreover, quantitative MTT and Trypan Blue assays were employed to validate PECs as feasible and safe nanoscaled carriers at single-cell level without adverse effects on metabolism and viability.

Cell Uptake and Validation of Novel PECs for Biomedical Applications

PubMed Central

Palamà, Ilaria E.; Musarò, Mariarosaria; Coluccia, Addolorata M. L.; D'Amone, Stefania; Gigli, Giuseppe

2011-01-01

This pilot study provides the proof of principle for biomedical application of novel polyelectrolyte complexes (PECs) obtained via electrostatic interactions between dextran sulphate (DXS) and poly(allylamine hydrochloride) (PAH). Scanning electron microscopy (SEM) and atomic force microscopy (AFM) showed that DXS/PAH polyelectrolyte complexes were Monodispersed with regular rounded-shape features and average diameters of 250 nm at 2 : 1 weight ratios of DXS/PAH. Fluorescently labelled DXS and fluorescein-isothiocyanate- (FITC-)conjugate DXS were used to follow cell uptake efficiency of PECs and biodegradability of their enzymatically degradable DXS-layers by using confocal laser scanning microscopy (CLSM). Moreover, quantitative MTT and Trypan Blue assays were employed to validate PECs as feasible and safe nanoscaled carriers at single-cell level without adverse effects on metabolism and viability. PMID:21876815

Effects of intravenous secretin on language and behavior of children with autism and gastrointestinal symptoms: a single-blinded, open-label pilot study.

PubMed

Lightdale, J R; Hayer, C; Duer, A; Lind-White, C; Jenkins, S; Siegel, B; Elliott, G R; Heyman, M B

2001-11-01

Autism is a severe developmental disorder with poorly understood etiology. A recently published case series describes 3 autistic children with gastrointestinal symptoms who underwent endoscopy and intravenous administration of secretin and were subsequently noted by their parents to demonstrate improved language skills over a 5-week period. This report sparked tremendous public interest, and investigators at several sites moved quickly to design controlled trials to test the efficacy of secretin as a therapy for autistic children. However, this is the first effort specifically designed to replicate the initial reported findings in terms of patient age, presenting symptoms, and drug administration. To rigorously apply the scientific method by assessing the reproducibility of the reported effects of intravenous secretin on the language of young children with autism and gastrointestinal symptoms. We performed a single-blinded, prospective, open-label trial by conducting formal language testing and blinded behavioral rating both before and repeatedly after a standardized infusion of secretin. We selected autistic children who were similar in age and profile to those described in the published retrospective case review. Inclusion criteria for study participation included age (3-6 years), confirmed diagnosis of autism, and reported gastrointestinal symptoms (16 had chronic diarrhea, 2 had gastroesophageal reflux, and 2 had chronic constipation). Twenty children (18 male) were admitted to the Pediatric Clinical Research Center at the University of California, San Francisco after administration of the Preschool Language Scale-3 (PLS-3). A 3 CU/kg dose of secretin (Secretin-Ferring) was administered intravenously (upper endoscopy was not performed). Behavioral ratings were derived using the Autism Observation Scale applied to a 30-minute time sample of the child's behavior consisting of a videotape of the PLS-3 (structured setting) and a second free play session with a standard set of developmentally appropriate toys. Participants then returned for follow-up evaluations, with readministrations of the PLS-3 at 1, 2, 3, and 5 weeks' postinfusion, and videotaping of each session for later blinded review by 2 independent observers using the Autism Observation Scale, uninformed about week of posttreatment. We also surveyed parents of our study children about their impressions of the effects of secretin using a 5-point Likert scale for parents to rate changes seen in their child. With a total study completion rate across all participants of 96%, repeated measures analyses of variance revealed no significant increases in children's language skills from baseline across all 5 study time periods after a single infusion of secretin. Similarly, neither significant decreases in atypical behaviors nor increases in prosocial behaviors and developmentally appropriate play skills emerged. Furthermore, no relationship was found between parental reports of change and observable improvement in the sample. Despite the objective lack of drug effect, 70% of parents in our study reported moderate to high change in their child's language and behavior. Furthermore, 85% of parents reported that they felt that their child would obtain at least some additional benefits from another infusion of secretin. The results of our pilot study indicate that intravenous secretin had no effects in a 5-week period on the language and behavior of 20 children with autism and gastrointestinal symptoms. The open-label, prospective design of our study with blinded reviews of patients both before and after secretin administration follows the scientific method by seeking to reproduce an observed phenomenon using validating and reliable outcome measures. Pilot studies remain a mandatory step for the design of future randomized, clinical trials investigating potential treatments for children with autism.

Effectiveness of ethinylestradiol/drospirenone for premenstrual symptoms in Japanese patients with dysmenorrhea: Open-label pilot study.

PubMed

Takeda, Takashi; Kondo, Akiko; Koga, Shoko; Hayakawa, Jun; Hayakawa, Kenichi; Hiramatsu, Keizo; Yaegashi, Nobuo

2015-10-01

A combined oral contraceptive containing ethinylestradiol 20 µg plus drospirenone 3 mg (EE20 + DRSP) in a 24/4 regimen has been shown to alleviate the symptoms of premenstrual syndrome and premenstrual dysphoric disorder. This study was conducted to evaluate the efficacy of EE20 + DRSP in Japanese patients with premenstrual symptoms. A multicenter, prospective, open-label, single-arm, phase IV study was performed in Japanese women with dysmenorrhea and premenstrual symptoms. They were treated with EE20 + DRSP to alleviate the symptoms of dysmenorrhea for six treatment cycles. Premenstrual symptoms were evaluated using a Premenstrual Symptoms Questionnaire at baseline and after three and six cycles of EE20 + DRSP. The degree of dysmenorrhea was also evaluated using a visual analog scale at baseline and after one, three, and six cycles of EE20 + DRSP. Forty-eight patients were treated with EE20 + DRSP. Most of the premenstrual symptoms were alleviated significantly by three and six cycles of EE20 + DRSP treatment. EE20 + DRSP treatment significantly improved the severity of premenstrual symptoms. We also confirmed the effectiveness of EE20 + DRSP for the treatment for dysmenorrhea. This study showed that EE20 + DRSP could be a useful treatment strategy for premenstrual symptoms in Japanese women. © 2015 Japan Society of Obstetrics and Gynecology.

The effects of hyperbaric oxygen therapy on oxidative stress, inflammation, and symptoms in children with autism: an open-label pilot study

PubMed Central

Rossignol, Daniel A; Rossignol, Lanier W; James, S Jill; Melnyk, Stepan; Mumper, Elizabeth

2007-01-01

Background Recently, hyperbaric oxygen therapy (HBOT) has increased in popularity as a treatment for autism. Numerous studies document oxidative stress and inflammation in individuals with autism; both of these conditions have demonstrated improvement with HBOT, along with enhancement of neurological function and cognitive performance. In this study, children with autism were treated with HBOT at atmospheric pressures and oxygen concentrations in current use for this condition. Changes in markers of oxidative stress and inflammation were measured. The children were evaluated to determine clinical effects and safety. Methods Eighteen children with autism, ages 3–16 years, underwent 40 hyperbaric sessions of 45 minutes duration each at either 1.5 atmospheres (atm) and 100% oxygen, or at 1.3 atm and 24% oxygen. Measurements of C-reactive protein (CRP) and markers of oxidative stress, including plasma oxidized glutathione (GSSG), were assessed by fasting blood draws collected before and after the 40 treatments. Changes in clinical symptoms, as rated by parents, were also assessed. The children were closely monitored for potential adverse effects. Results At the endpoint of 40 hyperbaric sessions, neither group demonstrated statistically significant changes in mean plasma GSSG levels, indicating intracellular oxidative stress appears unaffected by either regimen. A trend towards improvement in mean CRP was present in both groups; the largest improvements were observed in children with initially higher elevations in CRP. When all 18 children were pooled, a significant improvement in CRP was found (p = 0.021). Pre- and post-parental observations indicated statistically significant improvements in both groups, including motivation, speech, and cognitive awareness (p < 0.05). No major adverse events were observed. Conclusion In this prospective pilot study of children with autism, HBOT at a maximum pressure of 1.5 atm with up to 100% oxygen was safe and well tolerated. HBOT did not appreciably worsen oxidative stress and significantly decreased inflammation as measured by CRP levels. Parental observations support anecdotal accounts of improvement in several domains of autism. However, since this was an open-label study, definitive statements regarding the efficacy of HBOT for the treatment of individuals with autism must await results from double-blind, controlled trials. Trial Registration clinicaltrials.gov NCT00324909 PMID:18005455

Visual analytics for aviation safety: A collaborative approach to sensemaking

NASA Astrophysics Data System (ADS)

Wade, Andrew

Visual analytics, the "science of analytical reasoning facilitated by interactive visual interfaces", is more than just visualization. Understanding the human reasoning process is essential for designing effective visualization tools and providing correct analyses. This thesis describes the evolution, application and evaluation of a new method for studying analytical reasoning that we have labeled paired analysis. Paired analysis combines subject matter experts (SMEs) and tool experts (TE) in an analytic dyad, here used to investigate aircraft maintenance and safety data. The method was developed and evaluated using interviews, pilot studies and analytic sessions during an internship at the Boeing Company. By enabling a collaborative approach to sensemaking that can be captured by researchers, paired analysis yielded rich data on human analytical reasoning that can be used to support analytic tool development and analyst training. Keywords: visual analytics, paired analysis, sensemaking, boeing, collaborative analysis.

Multiplexed MRM-based assays for the quantitation of proteins in mouse plasma and heart tissue.

PubMed

Percy, Andrew J; Michaud, Sarah A; Jardim, Armando; Sinclair, Nicholas J; Zhang, Suping; Mohammed, Yassene; Palmer, Andrea L; Hardie, Darryl B; Yang, Juncong; LeBlanc, Andre M; Borchers, Christoph H

2017-04-01

The mouse is the most commonly used laboratory animal, with more than 14 million mice being used for research each year in North America alone. The number and diversity of mouse models is increasing rapidly through genetic engineering strategies, but detailed characterization of these models is still challenging because most phenotypic information is derived from time-consuming histological and biochemical analyses. To expand the biochemists' toolkit, we generated a set of targeted proteomic assays for mouse plasma and heart tissue, utilizing bottom-up LC/MRM-MS with isotope-labeled peptides as internal standards. Protein quantitation was performed using reverse standard curves, with LC-MS platform and curve performance evaluated by quality control standards. The assays comprising the final panel (101 peptides for 81 proteins in plasma; 227 peptides for 159 proteins in heart tissue) have been rigorously developed under a fit-for-purpose approach and utilize stable-isotope labeled peptides for every analyte to provide high-quality, precise relative quantitation. In addition, the peptides have been tested to be interference-free and the assay is highly multiplexed, with reproducibly determined protein concentrations spanning >4 orders of magnitude. The developed assays have been used in a small pilot study to demonstrate their application to molecular phenotyping or biomarker discovery/verification studies. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Effect of noninvasive vagus nerve stimulation on acute migraine: an open-label pilot study.

PubMed

Goadsby, P J; Grosberg, B M; Mauskop, A; Cady, R; Simmons, K A

2014-10-01

We sought to assess a novel, noninvasive, portable vagal nerve stimulator (nVNS) for acute treatment of migraine. Participants with migraine with or without aura were eligible for an open-label, single-arm, multiple-attack study. Up to four migraine attacks were treated with two 90-second doses, at 15-minute intervals delivered to the right cervical branch of the vagus nerve within a six-week time period. Subjects were asked to self-treat at moderate or severe pain, or after 20 minutes of mild pain. Of 30 enrolled patients (25 females, five males, median age 39), two treated no attacks, and one treated aura only, leaving a Full Analysis Set of 27 treating 80 attacks with pain. An adverse event was reported in 13 patients, notably: neck twitching (n = 1), raspy voice (n = 1) and redness at the device site (n = 1). No unanticipated, serious or severe adverse events were reported. The pain-free rate at two hours was four of 19 (21%) for the first treated attack with a moderate or severe headache at baseline. For all moderate or severe attacks at baseline, the pain-free rate was 12/54 (22%). nVNS may be an effective and well-tolerated acute treatment for migraine in certain patients. © International Headache Society 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

An open label pilot study of citalopram for depression and boredom in ambulatory cancer patients.

PubMed

Theobald, Dale E; Kirsh, Kenneth L; Holtsclaw, Elizabeth; Donaghy, Kathleen; Passik, Steven D

2003-03-01

Significant levels of depressive symptoms are an impediment to adjustment and affect greater than one-third of people with cancer. The clinical diagnosis of major depression is estimated to occur in 25%. Depression is dramatically underrecognized by oncologists and oncology nurses, and as a result, often undertreated. Clinical experience suggests that antidepressants of virtually all types are well tolerated and potentially efficacious. There is, however, a lack of an evidence base for the use of antidepressants in cancer patients. We undertook an open-label pilot study using citalopram in 30 cancer patients who reported a high level of depressive symptoms on the Zung Self-Rating Depression Scale (ZSDS). In addition to the ZSDS, eligible patients completed a series of visual analog scales for pain, depression, and sleep disturbance; the Functional Assessment of Cancer Therapy-General Module; and the Purposelessness, Understimulation, and Boredom Scale developed by the research team. Patients began a 2-month course of therapy with citalopram 20 mg, increasing to 40 mg at the end of the fourth week if the patient was in the same range of depressive symptoms as measured by the ZSDS. Twenty-one of 30 patients completed the protocol. The average age of the sample was 57.32 years (SD = 12.6) and was comprised of 11 women (52.4%) and 10 men (47.6%). Depressive symptoms decreased and quality of life improved during the 8-week treatment period. Of special interest was the rate of improvement in boredom, and using the total boredom score of the PUB, significant improvement compared to baseline was seen in weeks 6 (F = 5.266, p < .05) and 8 (F = 9.248, p < .01). Overall, the positive findings suggest the need for a randomized, double-blind, placebo-controlled trial of citalopram in cancer patients. Regarding the interplay of boredom and depression, the relationship between improvements in depressive symptoms and boredom is complex. This is illustrated by the way in which the different elements respond to antidepressant treatment. Depression began to improve almost immediately upon initiation of treatment whereas improvement in boredom does not become evident until week 6.

A land cover change detection and classification protocol for updating Alaska NLCD 2001 to 2011

USGS Publications Warehouse

Jin, Suming; Yang, Limin; Zhu, Zhe; Homer, Collin G.

2017-01-01

Monitoring and mapping land cover changes are important ways to support evaluation of the status and transition of ecosystems. The Alaska National Land Cover Database (NLCD) 2001 was the first 30-m resolution baseline land cover product of the entire state derived from circa 2001 Landsat imagery and geospatial ancillary data. We developed a comprehensive approach named AKUP11 to update Alaska NLCD from 2001 to 2011 and provide a 10-year cyclical update of the state's land cover and land cover changes. Our method is designed to characterize the main land cover changes associated with different drivers, including the conversion of forests to shrub and grassland primarily as a result of wildland fire and forest harvest, the vegetation successional processes after disturbance, and changes of surface water extent and glacier ice/snow associated with weather and climate changes. For natural vegetated areas, a component named AKUP11-VEG was developed for updating the land cover that involves four major steps: 1) identify the disturbed and successional areas using Landsat images and ancillary datasets; 2) update the land cover status for these areas using a SKILL model (System of Knowledge-based Integrated-trajectory Land cover Labeling); 3) perform decision tree classification; and 4) develop a final land cover and land cover change product through the postprocessing modeling. For water and ice/snow areas, another component named AKUP11-WIS was developed for initial land cover change detection, removal of the terrain shadow effects, and exclusion of ephemeral snow changes using a 3-year MODIS snow extent dataset from 2010 to 2012. The overall approach was tested in three pilot study areas in Alaska, with each area consisting of four Landsat image footprints. The results from the pilot study show that the overall accuracy in detecting change and no-change is 90% and the overall accuracy of the updated land cover label for 2011 is 86%. The method provided a robust, consistent, and efficient means for capturing major disturbance events and updating land cover for Alaska. The method has subsequently been applied to generate the land cover and land cover change products for the entire state of Alaska.

A Feasibility Pilot Trial of Individualized Homeopathic Treatment of Fatigue in Children Receiving Chemotherapy.

PubMed

Brulé, David; Gillmeister, Biljana; Lee, Michelle; Alexander, Sarah; Gassas, Adam; Hendershot, Eleanor; Zupanec, Sue; Dupuis, Lee; Sung, Lillian

2016-12-01

Fatigue is a major problem in children with cancer. The objective was to examine the feasibility of performing a clinical trial of homeopathic treatment for fatigue in children receiving chemotherapy. This was a single-institution, open-label, pilot study. Children 2 to 18 years old, diagnosed with cancer, and receiving chemotherapy were eligible. Participants were given individualized homeopathic treatment for a maximum of 14 days. In-home or clinic assessments were conducted up to 3 times weekly. Feasibility was defined as the ability to recruit and administer homeopathy to 10 participants within 1 year. Fatigue was measured using the Symptom Distress Scale daily and the PedsQL Multidimensional Fatigue Module weekly. Between April 2012 and April 2014, 155 potential participants were identified. There were 45 eligible and contacted patients; 36 declined participation, 30 because they were not interested; 9 agreed to participate, but 1 participant withdrew prior to treatment initiation. Median length of homeopathic treatment was 10.5 (range = 6 to 14) days. All parents found homeopathic treatment to be easy or very easy to follow. Trials of individualized homeopathy for fatigue reduction in pediatric cancer are not feasible in this context; lack of interest was a primary reason. Alternative approaches to evaluating homeopathy efficacy are needed. © The Author(s) 2015.

Implementation of 5S management method for lean healthcare at a health center in Senegal: a qualitative study of staff perception.

PubMed

Kanamori, Shogo; Sow, Seydou; Castro, Marcia C; Matsuno, Rui; Tsuru, Akiko; Jimba, Masamine

2015-01-01

5S is a lean method for workplace organization; it is an abbreviation representing five Japanese words that can be translated as sort, set in order, shine, standardize, and sustain. The 5S management method has been recognized recently as a potential solution for improving the quality of government healthcare services in low- and middle-income countries. To assess how the 5S management method creates changes in the workplace and in the process and outcomes of healthcare services, and how it can be applicable in a resource-poor setting, based on data from a pilot intervention of the 5S program implemented in a health facility in Senegal. In this qualitative study, we interviewed 21 health center staff members 1 year after the pilot intervention. We asked them about their views on the changes brought on by the 5S program in their workplace, daily routines, and services provided. We then transcribed interview records and organized the narrative information by emerging themes using thematic analysis in the coding process. Study participants indicated that, despite resource constraints and other demotivating factors present at the health center, the 5S program created changes in the work environment, including fewer unwanted items, improved orderliness, and improved labeling and directional indicators of service units. These efforts engendered changes in the quality of services (e.g. making services more efficient, patient-centered, and safe), and in the attitude and behavior of staff and patients. The pilot intervention of the 5S management method was perceived to have improved the quality of healthcare services and staff motivation in a resource-poor healthcare facility with a disorderly work environment in Senegal. Quantitative and qualitative research based on a larger-scale intervention would be needed to elaborate and validate these findings and to identify the cost-effectiveness of such intervention in low- and middle-income countries.

The effects of "The Work" meditation (Byron Katie) on psychological symptoms and quality of life--a pilot clinical study.

PubMed

Smernoff, Eric; Mitnik, Inbal; Kolodner, Ken; Lev-Ari, Shahar

2015-01-01

"The Work" is a meditative technique that enables the identification and investigation of thoughts that cause an individual stress and suffering. Its core is comprised of four questions and turnarounds that enable the participant to experience a different interpretation of reality. We assessed the effect of "The Work" meditation on quality of life and psychological symptoms in a non-clinical sample. This study was designed as a single-group pilot clinical trial (open label). Participants (n = 197) enrolled in a nine-day training course ("The School for The Work") and completed a set of self-administered measures on three occasions: before the course (n = 197), after the course (n = 164), and six months after course completion (n = 102). Beck Depression Inventory-II (BDI-II), Subjective Happiness Scale (SHS), Quality of Life Inventory (QOLI), Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR16), Outcome Questionnaire 45.2 (OQ-45.2), State-Trait Anger Expression Inventory-2 (STAXI-2), and State-Trait Anxiety Inventory (STAI). A mixed models analysis revealed significant positive changes between baseline compared to the end of the intervention and six-month follow-up in all measures: BDI-II (t = 10.24, P < .0001), SHS (t = -9.07, P <.0001), QOLI (t = -5.69, P < .0001), QIDS-SR16 (t = 9.35, P < .0001), OQ-45.2 (t = 11.74, P < .0001), STAXI-2 (State) (t = 3.69, P = .0003), STAXI-2 (Trait) (t = 7.8, P < .0001), STAI (State) (t = 11.46, P < .0001), and STAI (Trait) (t = 10.75, P < .0001). The promising results of this pilot study warrant randomized clinical trials to validate "The Work" meditation technique as an effective intervention for improvement in psychological state and quality of life in the general population. Copyright © 2015 Elsevier Inc. All rights reserved.

Implementation of 5S management method for lean healthcare at a health center in Senegal: a qualitative study of staff perception

PubMed Central

Kanamori, Shogo; Sow, Seydou; Castro, Marcia C.; Matsuno, Rui; Tsuru, Akiko; Jimba, Masamine

2015-01-01

Background 5S is a lean method for workplace organization; it is an abbreviation representing five Japanese words that can be translated as sort, set in order, shine, standardize, and sustain. The 5S management method has been recognized recently as a potential solution for improving the quality of government healthcare services in low- and middle-income countries. Objective To assess how the 5S management method creates changes in the workplace and in the process and outcomes of healthcare services, and how it can be applicable in a resource-poor setting, based on data from a pilot intervention of the 5S program implemented in a health facility in Senegal. Design In this qualitative study, we interviewed 21 health center staff members 1 year after the pilot intervention. We asked them about their views on the changes brought on by the 5S program in their workplace, daily routines, and services provided. We then transcribed interview records and organized the narrative information by emerging themes using thematic analysis in the coding process. Results Study participants indicated that, despite resource constraints and other demotivating factors present at the health center, the 5S program created changes in the work environment, including fewer unwanted items, improved orderliness, and improved labeling and directional indicators of service units. These efforts engendered changes in the quality of services (e.g. making services more efficient, patient-centered, and safe), and in the attitude and behavior of staff and patients. Conclusions The pilot intervention of the 5S management method was perceived to have improved the quality of healthcare services and staff motivation in a resource-poor healthcare facility with a disorderly work environment in Senegal. Quantitative and qualitative research based on a larger-scale intervention would be needed to elaborate and validate these findings and to identify the cost-effectiveness of such intervention in low- and middle-income countries. PMID:25854781

The breakdown of coordinated decision making in distributed systems.

PubMed

Bearman, Christopher; Paletz, Susannah B F; Orasanu, Judith; Thomas, Matthew J W

2010-04-01

This article aims to explore the nature and resolution of breakdowns in coordinated decision making in distributed safety-critical systems. In safety-critical domains, people with different roles and responsibilities often must work together to make coordinated decisions while geographically distributed. Although there is likely to be a large degree of overlap in the shared mental models of these people on the basis of procedures and experience, subtle differences may exist. Study 1 involves using Aviation Safety Reporting System reports to explore the ways in which coordinated decision making breaks down between pilots and air traffic controllers and the way in which the breakdowns are resolved. Study 2 replicates and extends those findings with the use of transcripts from the Apollo 13 National Aeronautics and Space Administration space mission. Across both studies, breakdowns were caused in part by different types of lower-level breakdowns (or disconnects), which are labeled as operational, informational, or evaluative. Evaluative disconnects were found to be significantly harder to resolve than other types of disconnects. Considering breakdowns according to the type of disconnect involved appears to capture useful information that should assist accident and incident investigators. The current trend in aviation of shifting responsibilities and providing increasingly more information to pilots may have a hidden cost of increasing evaluative disconnects. The proposed taxonomy facilitates the investigation of breakdowns in coordinated decision making and draws attention to the importance of considering subtle differences between participants' mental models when considering complex distributed systems.

A pilot randomized placebo-controlled trial of adjunctive aripiprazole for chronic PTSD in US military Veterans resistant to antidepressant treatment.

PubMed

Naylor, Jennifer C; Kilts, Jason D; Bradford, Daniel W; Strauss, Jennifer L; Capehart, Bruce P; Szabo, Steven T; Smith, Karen D; Dunn, Charlotte E; Conner, Kathryn M; Davidson, Jonathan R T; Wagner, Henry Ryan; Hamer, Robert M; Marx, Christine E

2015-05-01

Many individuals with post-traumatic stress disorder (PTSD) experience persistent symptoms despite pharmacological treatment with antidepressants. Several open-label monotherapy and adjunctive studies have suggested that aripiprazole (a second-generation antipsychotic) may have clinical utility in PTSD. However, there have been no randomized placebo-controlled trials of aripiprazole use for PTSD. We thus conducted a pilot randomized controlled trial of adjunctive aripiprazole versus placebo among Veterans with chronic PTSD serving in the US military since 11 September 2001 to assess the feasibility, safety, tolerability, and therapeutic potential of aripiprazole. Sixteen Veterans were randomized, and 14 completed at least 4 weeks of the study; 12 completed the entire 8-week trial. Outcome measures included the Clinician-Administered PTSD Scale (CAPS), PTSD Checklist, Beck Depression Inventory, Second Edition, and Positive and Negative Syndrome Scale scores. Aripiprazole was well-tolerated in this cohort, and improvements in CAPS, PTSD Checklist, Beck Depression Inventory, Second Edition, and Positive and Negative Syndrome Scale scores were as hypothesized. Although CAPS change scores did not reach statistical significance, aripiprazole outperformed placebo by 9 points on the CAPS in the last observation carried forward analysis compared with the placebo group (n = 7 per group), and by 20 points in the group randomized to aripiprazole that completed the entire study (n = 5) compared with the placebo group (n = 7). Results suggest promise for aripiprazole as an adjunctive strategy for the treatment of PTSD.

Increasing fruit and vegetable consumption and offerings to Somali children: the FAV-S pilot study.

PubMed

Hearst, Mary O; Kehm, Rebecca; Sherman, Shelley; Lechner, Kate E

2014-04-01

To determine the feasibility, acceptability, and impact of a parent-centered intervention to increase fruit and vegetable servings and consumption among Somali children living in the United States. Pilot intervention that included Somali community health workers who organized groups of 3 or 4 women to participate in 2 initial educational sessions, including topics of health and nutrition, serving size, and label reading. A third session taught interactive cooking to increase skills in preparing fruits and vegetables and increasing the numbers of vegetables included in traditional Somali dishes. The final session was a trip to the grocery store to identify fruits and vegetables, determine ripeness, and explore frozen and canned fruits and vegetables for halal, low-sodium, and low-sugar products. Surveys were completed pre- and post-intervention. Study participants were recruited from a large housing complex in Minneapolis, Minnesota, with a high population of Somali immigrants. Somali women (N = 25) with children aged 3 to 10 years. The intervention was feasible and well accepted. In comparing pre- and post-intervention surveys, mothers reported providing their children significantly more frequent servings of fruits and vegetables at dinner, lunch, snack, and breakfast (vegetable only). There was a statistically significant increase in parent-reported intake of fruits and vegetables for themselves and their children. The FAV-S study was feasible and acceptable, and it demonstrated potential for increasing fruit and vegetable servings and consumption among Somali children. A larger-scale randomized trial is needed to assess the impact of this intervention.

Pilot study assessing the effectiveness of long-lasting permethrin-impregnated clothing for the prevention of tick bites.

PubMed

Vaughn, Meagan F; Meshnick, Steven R

2011-07-01

Tick-borne diseases such as Lyme disease, Rocky Mountain spotted fever, and ehrlichiosis are a significant concern for many thousands of workers who have frequent and unavoidable exposure to tick-infested habitats. Many North Carolina state employees with outdoor occupations report multiple tick bites each year, indicating that existing tick preventive strategies may be underutilized or ineffective. Treatment of clothing with permethrin, a nontoxic chemical with insecticidal, knockdown, and repellent properties, is highly effective against ticks. However, most permethrin products must be reapplied after several washings to maintain insecticidal activity. Recently, a factory-based method for long-lasting permethrin impregnation of clothing has been developed by Insect Shield, Inc., that allows clothing to retain insecticidal activity for over 70 washes. A nonrandomized open label pilot study was conducted to determine the effectiveness of Insect Shield-treated clothing for the prevention of tick bites among 16 outdoor workers from the North Carolina Division of Water Quality under actual field conditions. Participants completed questionnaires at the start of follow-up (March, 2008) and at the end of follow-up (September, 2008), and tick bites and outdoor work hours were reported on weekly tick bite logs for the entire follow-up period. Subjects wearing Insect Shield-treated clothing had a 93% reduction (p < 0.0001) in the total incidence of tick bites compared to subjects using standard tick bite prevention measures. This study provides preliminary evidence that long-lasting permethrin-impregnated clothing may be highly effective against tick bites.

Waste Isolation Pilot Plant Biennial Environmental Compliance Report

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

Washinton TRU Solutions LLC

This Biennial Environmental Compliance Report (BECR) documents environmental regulatory compliance at the Waste Isolation Pilot Plant (WIPP), a facility designed for the safe disposal of transuranic (TRU) radioactive waste, for the reporting period of April 1, 2000, to March 31, 2002. As required by the WIPP Land Withdrawal Act (LWA)(Public Law [Pub. L.] 102-579, as amended by Pub. L. 104-201), the BECR documents U.S. Department of Energy (DOE) Carlsbad Field Office's (CBFO) compliance with applicable environmental protection laws and regulations implemented by agencies of the federal government and the state of New Mexico. In the prior BECR, the CBFO andmore » the management and operating contractor (MOC)committed to discuss resolution of a Letter of Violation that had been issued by the New Mexico Environment Department (NMED) in August 1999, which was during the previous BECR reporting period. This Letter of Violation alleged noncompliance with hazardous waste aisle spacing, labeling, a nd tank requirements. At the time of publication of the prior BECR, resolution of the Letter of Violation was pending. On July 7, 2000, the NMED issued a letter noting that the aisle spacing and labeling concerns had been adequately addressed and that they were rescinding the violation alleging that the Exhaust Shaft Catch Basin failed to comply with the requirements for a hazardous waste tank. During the current reporting period, WIPP received a Notice of Violation and a compliance order alleging the violation of the New Mexico Hazardous Waste Regulations and the WIPP Hazardous Waste Facility Permit (HWFP).« less

Working with grocers to reduce dietary sodium: lessons learned from the Broome County Sodium Reduction in Communities pilot project.

PubMed

Johnston, Yvonne A; McFadden, Mary; Lamphere, Marissa; Buch, Karen; Stark, Beth; Salton, Judith Lynn

2014-01-01

The purpose of this article is to describe implementation of and lessons learned from the Broome County Sodium Reduction in Communities grocery store initiative. This pilot project was conducted in collaboration with a regional supermarket chain and endeavored to develop population-based strategies for reducing sodium intake. Key interventions included marketing strategies, taste test demonstrations, and a public media campaign. Project staff worked closely with corporate registered dietitian nutritionists, a nutrition specialist, and an advertising agency in its development and implementation. A social marketing approach was used to educate consumers about the hidden sources of dietary sodium, to raise awareness of the adverse health effects of excess sodium intake, to encourage consumers to read food labels, and to urge them to purchase food items lower in sodium. The lessons learned from this experience may be of assistance to other communities that seek to implement similar sodium-reduction strategies in the grocery store environment.

Process and Outcomes From a Youth-Led Campaign to Address Healthy Eating in an Urban High School.

PubMed

Frerichs, Leah; Sjolie, Sarah; Curtis, Matthew; Peterson, Melissa; Huang, Terry T-K

2015-12-01

This article describes a pilot youth advocacy initiative for obesity prevention informed by social cognitive theory, social network theory, and theories of community mobilization. With assistance from school and health leaders, adolescent-aged youth led a cafeteria food labeling and social marketing campaign. We implemented an anonymous survey 2 weeks prior to and again at the conclusion of the campaign, and used cafeteria records to track servings of fruits and vegetables. The campaign resulted in a significant increase in youths' confidence to identify healthy foods (OR 1.97, 95 % CI 1.01, 3.84, p = .048), and a significant increase in per person per day servings of fruits (0.02, p = .03) and vegetables (0.01, p = .02). The results of our pilot were promising, and the integration of concepts from multiple theories benefited the implementation process. Obesity prevention initiatives should include strategies that encourage youth to create health promotion community networks and lead changes to their social and physical environments.

A Pilot Study of Safety and Efficacy of Cranial Electrotherapy Stimulation in Treatment of Bipolar II Depression

PubMed Central

McClure, Deimante; Greenman, Samantha C.; Koppolu, Siva Sundeep; Varvara, Maria; Yaseen, Zimri S.; Galynker, Igor I.

2015-01-01

Abstract This double-blind, sham-controlled study sought to investigate the effectiveness of cranial electrotherapy stimulation (CES) for the treatment of bipolar II depression (BD II). After randomization, the active group participants (n = 7) received 2 mA CES treatment for 20 minutes five days a week for 2 weeks, whereas the sham group (n = 9) had the CES device turned on and off. Symptom non-remitters from both groups received an additional 2 weeks of open-label active treatment. Active CES treatment but not sham treatment was associated with a significant decrease in the Beck Depression Inventory (BDI) scores from baseline to the second week (p = 0.003) maintaining significance until week 4 (p = 0.002). There was no difference between the groups in side effects frequency. The results of this small study indicate that CES may be a safe and effective treatment for BD II suggesting that further studies on safety and efficacy of CES may be warranted. PMID:26414234

A Pilot Study of Safety and Efficacy of Cranial Electrotherapy Stimulation in Treatment of Bipolar II Depression.

PubMed

McClure, Deimante; Greenman, Samantha C; Koppolu, Siva Sundeep; Varvara, Maria; Yaseen, Zimri S; Galynker, Igor I

2015-11-01

This double-blind, sham-controlled study sought to investigate the effectiveness of cranial electrotherapy stimulation (CES) for the treatment of bipolar II depression (BD II). After randomization, the active group participants (n = 7) received 2 mA CES treatment for 20 minutes five days a week for 2 weeks, whereas the sham group (n = 9) had the CES device turned on and off. Symptom non-remitters from both groups received an additional 2 weeks of open-label active treatment. Active CES treatment but not sham treatment was associated with a significant decrease in the Beck Depression Inventory (BDI) scores from baseline to the second week (p = 0.003) maintaining significance until week 4 (p = 0.002). There was no difference between the groups in side effects frequency. The results of this small study indicate that CES may be a safe and effective treatment for BD II suggesting that further studies on safety and efficacy of CES may be warranted.

An integrated workflow for multiplex CSF proteomics and peptidomics-identification of candidate cerebrospinal fluid biomarkers of Alzheimer's disease.

PubMed

Hölttä, Mikko; Minthon, Lennart; Hansson, Oskar; Holmén-Larsson, Jessica; Pike, Ian; Ward, Malcolm; Kuhn, Karsten; Rüetschi, Ulla; Zetterberg, Henrik; Blennow, Kaj; Gobom, Johan

2015-02-06

Many disease processes in the brain are reflected in the protein composition of the cerebrospinal fluid (CSF). In addition to proteins, CSF also contains a large number of endogenous peptides whose potential as disease biomarkers largely remains to be explored. We have developed a novel workflow in which multiplex isobaric labeling is used for simultaneous quantification of endogenous CSF peptides and proteins by liquid chromatography coupled with mass spectrometry. After the labeling of CSF samples, endogenous peptides are separated from proteins by ultrafiltration. The proteins retained on the filters are trypsinized, and the tryptic peptides are collected separately. We evaluated this technique in a comparative pilot study of CSF peptide and protein profiles in eight patients with Alzheimer's disease (AD) and eight nondemented controls. We identified several differences between the AD and control group among endogenous peptides derived from proteins known to be associated with AD, including neurosecretory protein VGF (ratios AD/controls 0.45-0.81), integral membrane protein 2B (ratios AD/controls 0.72-0.84), and metallothionein-3 (ratios AD/controls 0.51-0.61). Analysis of tryptic peptides identified several proteins that were altered in the AD group, some of which have previously been reported as changed in AD, for example, VGF (ratio AD/controls 0.70).

Total energy expenditure and body composition of children with developmental disabilities.

PubMed

Polfuss, Michele; Sawin, Kathleen J; Papanek, Paula E; Bandini, Linda; Forseth, Bethany; Moosreiner, Andrea; Zvara, Kimberley; Schoeller, Dale A

2018-07-01

Obesity prevalence is increased in children with developmental disabilities, specifically in children with spina bifida and Down syndrome. Energy expenditure, a critical aspect of weight management, has been extensively studied in the typically developing population, but not adequately studied in children with developmental disabilities. Determine energy expenditure, fat-free mass and body fat percentile and the impact of these findings on recommended caloric intake in children with spina bifida and Down syndrome. This pilot study included 36 children, 18 with spina bifida, 9 with Down syndrome and 9 typically developing children. Half of the children with spina bifida were non-ambulatory. Doubly labeled water was used to measure energy expenditure and body composition. Descriptive statistics described the sample and MANOVA and ANOVA methods were used to evaluate differences between groups. Energy expenditure was significantly less for children with spina bifida who primarily used a wheelchair (p = .001) and children with Down syndrome (p = .041) when compared to children without a disability when adjusted for fat-free mass. However, no significant difference was detected in children with spina bifida who ambulated without assistance (p = .072). Children with spina bifida and Down syndrome have a significantly decreased energy expenditure which directly impacts recommended caloric intake. No significant difference was detected for children with spina bifida who ambulated, although the small sample size of this pilot study may have limited these findings. Validating these results in a larger study is integral to supporting successful weight management of these children. Copyright © 2017 Elsevier Inc. All rights reserved.

"Black cloud" vs. "white cloud" physicians - Myth or reality in apheresis medicine?

PubMed

Pham, Huy P; Raju, Dheeraj; Jiang, Ning; Williams, Lance A

2017-08-01

Many practitioners believe in the phenomenon of either being labeled a "black cloud" or "white cloud" while on-call. A "white-cloud" physician is one who usually gets fewer cases. A "black-cloud" is one who often has more cases. It is unclear if the designation is only superstitious or if there is some merit. Our aim is to objectively assess this phenomenon in apheresis medicine at our center. A one-year prospective study from 12/2014 to 11/2015 was designed to evaluate the number of times apheresis physicians and nurses were involved with emergent apheresis procedures between the hours from 10 PM and 7 AM. Other parameters collected include the names of the physician, apheresis nurse, type of emergent apheresis procedure, day of the week, and season of the year. During the study period, 32 emergent procedures (or "black-cloud" events) occurred. The median time between two consecutive events was 8 days (range: 1-34 days). We found no statistically significant association between the "black-cloud" events and attending physicians, nurses, day of the week, or season of the year by Chi-square and Fisher's analyses. However, exploratory analysis using association rule demonstrated that "black-cloud" events were more likely to happen on Thursday (2.19 times), with attending physician 2 (1.18 times), and during winter (1.15 times). The results of this pilot study may support the common perception that some physicians or nurses are either "black cloud" or "white cloud". A larger, multi-center study population is needed to validate the results of this pilot study. © 2016 Wiley Periodicals, Inc.

Safety and efficacy evaluation of tretinoin cream 0.02% for the reduction of photodamage: a pilot study.

PubMed

Kircik, Leon H

2012-01-01

Clinical studies as well as histologic data maintain that tretinoin improves the appearance of photodamage; however, the long-term benefits of tretinoin 0.02% in moderate to severe photodamage have not been established. We performed independent assessments to demonstrate the long-term safety and efficacy of tretinoin emollient cream 0.02% for moderate to severe facial photodamage. A single-center, open-label, single-group observational study followed 19 patients over 52 weeks. Efficacy assessments consisted of the Glogau Photodamage Classification Scale and severity grading of photodamage signs and symptoms. Facial photography and biopsies were taken from three subjects at baseline and final visits. Tolerability was assessed by the investigator. Twelve patients completed 52 weeks of treatment. Mean change in Glogau photodamage demonstrated statistically significant differences at 3, 6, 9, and 12 months (P<.0005). All patients with moderate to severe photodamage had improved to mild photodamage status by 9 months. Statistically significant improvements (P<.05) were observed at all time points for fine wrinkling, tactile roughness, and mottled hyperpigmentation as well as for lentigines at 6, 9, and 12 months and telangiectasia at 12 months. Biopsy samples revealed microscopic improvement in photodamage. Tretinoin cream 0.02% was generally well-tolerated, with few subjects experiencing adverse events. Our pilot study is limited by lack of control and the small study sample. Tretinoin cream 0.02% was safe and effective for moderate to severe photodamage of facial skin and demonstrated sustainable benefits over an entire year based on the clinically validated Glogau classification system and expert visual grading analysis.

Remote sensing techniques applied to multispectral recognition of the Aranjuez pilot zone

NASA Technical Reports Server (NTRS)

Lemos, G. L.; Salinas, J.; Rebollo, M.

1977-01-01

A rectangular (7 x 14 km) area 40 km S of Madrid was remote-sensed with a three-stage recognition process. Ground truth was established in the first phase, airborne sensing with a multispectral scanner and photographic cameras were used in the second phase, and Landsat satellite data were obtained in the third phase. Agronomic and hydrological photointerpretation problems are discussed. Color, black/white, and labeled areas are displayed for crop recognition in the land-use survey; turbidity, concentrations of pollutants and natural chemicals, and densitometry of the water are considered in the evaluation of water resources.

Changes in Clinical Parameters in Patients with Tension-type Headache Following Massage Therapy: A Pilot Study

PubMed Central

Moraska, Albert; Chandler, Clint

2008-01-01

Complementary and alternative medicine approaches to treatment for tension-type headache are increasingly popular among patients, but evidence supporting its efficacy is limited. The objective of this study was to assess short term changes on primary and secondary headache pain measures in patients with tension-type headache (TTH) receiving a structured massage therapy program with a focus on myofascial trigger point therapy. Participants were enrolled in an open label trial using a baseline control with four 3-week phases: baseline, massage (two 3-week phases) and follow-up. Twice weekly, 45-minute massage sessions commenced following the baseline phase. A daily headache diary was maintained throughout the study in which participants recorded headache incidence, intensity, and duration. The Headache Disability Index was administered upon study entry and at 3-week intervals thereafter. 18 subjects were enrolled with 16 completing all headache diary, evaluation, and massage assignments. Study participants reported a median of 7.5 years with TTH. Headache frequency decreased from 4.7±0.7 episodes per week during baseline to 3.7±0.9 during treatment period 2 (P<0.001); reduction was also noted during the follow-up phase (3.2±1.0). Secondary measures of headache also decreased across the study phases with headache intensity decreasing by 30% (P<0.01) and headache duration from 4.0±1.3 to 2.8±0.5 hours (P<0.05). A corresponding improvement in Headache Disability Index was found with massage (P<0.001). This pilot study provides preliminary evidence for reduction in headache pain and disability with massage therapy that targets myofascial trigger points, suggesting the need for more rigorously controlled studies. PMID:19119396

Female pattern hair loss: a pilot study investigating combination therapy with low-dose oral minoxidil and spironolactone.

PubMed

Sinclair, Rodney D

2018-01-01

Minoxidil and spironolactone are oral antihypertensives known to stimulate hair growth. To report on a case series of women with pattern hair loss (PHL) treated with once daily minoxidil 0.25 mg and spironolactone 25 mg. Women newly diagnosed with a Sinclair stage 2-5 PHL were scored for hair shedding and hair density before and after 12 months of treatment with oral minoxidil 0.25 mg and spironolactone 25 mg. A total of 100 women were included in this observational pilot study. Mean age was 48.44 years (range 18-80). Mean hair loss severity at baseline was Sinclair 2.79 (range 2-5). Mean hair shedding score at baseline was 4.82. Mean duration of diagnosis was 6.5 years (range 0.5-30). Mean reduction in hair loss severity score was 0.85 at 6 months and 1.3 at 12 months. Mean reduction in hair shedding score was 2.3 at 6 months and 2.6 at 12 months. Mean change in blood pressure was -4.52 mmHg systolic and -6.48 mmHg diastolic. Side effects were seen in eight women but were generally mild. No patients developed hyperkalemia or any other blood test abnormality. Six of these women continued treatment, and two women who developed urticaria discontinued treatment. Prospective, uncontrolled, open-label observational study. Once daily capsules containing minoxidil 0.25 mg and spironolactone 25 mg appear to be safe and effective in the treatment of FPHL. Placebo-controlled studies to investigate this further are warranted. © 2017 The International Society of Dermatology.

A first-in-man study of 68Ga-nanocolloid PET-CT sentinel lymph node imaging in prostate cancer demonstrates aberrant lymphatic drainage pathways.

PubMed

Doughton, Jacki A; Hofman, Michael S; Eu, Peter; Hicks, Rodney J; Williams, Scott G

2018-05-04

Purpose: To assess feasibility, safety and utility of a novel 68 Ga-nanocolloid radio-tracer with PET-CT lymphoscintigraphy for identification of sentinel lymph nodes (SLN). Methods: Pilot study of patients from a tertiary cancer hospital who required insertion of gold fiducials for prostate cancer radiation therapy. Participation did not affect cancer management. Ultrasound-guided transperineal intra-prostatic injection of PET tracer (iron oxide nanocolloid labelled with gallium-68) after placement of fiducials. PET-CT lymphoscintigraphy imaging at approximately 45 and 100 minutes after in-jection of tracer. The study was monitored using Bayesian trial design with the as-sumption that at least one sentinel lymph node (SLN) could be identified in at least two-thirds of cases with >80% confidence. Results: SLN identification was successful in all 5 participants, allowing completion of the pilot study as per protocol. No adverse effects were observed. Unexpected po-tential pathways for transit of malignant cells as well as expected regional drainage pathways were discovered. Rapid tracer drainage to pelvic bone, perivesical, mesorec-tal, inguinal and Virchow's nodes was identified. Conclusion: SLN identification using 68 Ga-nanocolloid PET-CT can be successfully performed. Non-traditional pathways of disease spread were identified including drainage to pelvic bone as well as perivesical, mesorectal, inguinal and Virchow's nodes. Prevalence of both aberrant and non-lymphatic pathways of spread should be further investigated with this technique. Copyright © 2018 by the Society of Nuclear Medicine and Molecular Imaging, Inc.

Autologous platelet-rich plasma in the treatment of venous leg ulcers in primary care: a randomised controlled, pilot study.

PubMed

Burgos-Alonso, Natalia; Lobato, Igone; Hernández, Igone; Sebastian, Kepa San; Rodríguez, Begoña; March, Anna Giné; Perez-Salvador, Adriana; Arce, Veronica; Garcia-Alvarez, Arturo; Gomez-Fernandez, Maria Cruz; Grandes, Gonzalo; Andia, Isabel

2018-06-01

To examine the potential efficacy and safety of autologous platelet-rich plasma (PRP) in comparison with the conventional treatment (standard care, SoC) for the treatment of leg ulcers in patients with chronic venous insufficiency, in a primary health-care setting. A Phase I-II, open-label, parallel-group, multicentre, randomised pilot study was conducted. The outcome variables at baseline and at weeks five and nine included reduction in the ulcer area, Chronic Venous Insufficiency Quality of Life Questionnaire score, cost of the treatment for up to nine weeks and average weekly cure rate. A total of eight patients, each with at least a six-month history of venous leg ulcer (VLUs), were included in the study. A total of 12 ulcers were treated with either autologous PRP or standard SoC. Patients treated with PRP required wound care only once per week. In the SoC group, patients required intervention 2-3 times per week. A reduction in the mean ulcer size in the PRP group was 3.9cm 2 compared with the SoC group at 3.2cm 2 , although the sample size was insufficient to reach statistical significance. Improvement in quality of life (QoL) score was observed in the patients in the PRP group. This study offers proof-of-concept of the feasibility and safety of PRP treatment to inform larger clinical trials in patients with VLUs. Our preliminary results suggest that PRP delivers a safe and effective treatment for VLU care that can be implemented in primary health-care settings.

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.

Treatment of molluscum contagiosum with an East Indian sandalwood oil product.

PubMed

Haque, Malika; Coury, Daniel L

2017-11-22

To evaluate the safety and efficacy of an East Indian sandalwood oil (EISO) product as a topical treatment for molluscum contagiosum. Ten subjects ranging in age from 22 months to 29 years were recruited. Subjects were instructed to apply an EISO product to the lesions twice daily. Subjects were monitored every two to three weeks during the study and were questioned regarding local or systemic side effects. Assessment of response was recorded by counting lesions and documented by photographs. Nine of ten subjects (90%) experienced complete resolution of molluscum lesions within the twelve week study period. Response was unrelated to lesion size or number, how long the molluscum rash had been present, or patient age or gender. There were no complaints of side effects, skin irritation, pain, or other adverse events reported in any subjects. In this pilot open label study, an EISO product proved to be an effective treatment for molluscum contagiosum lesions with resolution of lesions typically occurring within twelve weeks of therapy.

Ambroxol for fibromyalgia: one group pretest-posttest open-label pilot study.

PubMed

Martínez-Martínez, Laura-Aline; Pérez, Luis-Fernando; Becerril-Mendoza, Lizbeth-Teresa; Rodríguez-Henriquez, Pedro; Muñoz, Omar-Eloy; Acosta, Gumaro; Silveira, Luis H; Vargas, Angélica; Barrera-Villalpando, María-Isabel; Martínez-Lavín, Manuel

2017-08-01

A consistent line of investigation proposes that fibromyalgia is a sympathetically maintained neuropathic pain syndrome. Dorsal root ganglia sodium channels may play a major role in fibromyalgia pain transmission. Ambroxol is a secretolytic agent used in the treatment of various airway disorders. Recently, it was discovered that this compound is also an efficient sodium channel blocker with potent anti-neuropathic pain properties. We evaluated the add-on effect of ambroxol to the treatment of fibromyalgia. We studied 25 patients with fibromyalgia. Ambroxol was prescribed at the usual clinical dose of 30 mg PO 3 times a day × 1 month. At the beginning and at the end of the study, all participants filled out the Revised Fibromyalgia Impact Questionnaire (FIQ-R) and the 2010 ACR diagnostic criteria including the widespread pain index (WPI). At the end of the study, FIQ-R decreased from a baseline value of 62 ± 15 to 51 ± 19 (p = 0.013). Pain visual analogue scale decreased from 77 ± 14 to 56 ± 30 (p = 0.018). WPI diminished from 14.6 ± 3.1 to 10.4 ± 5.3 (p = 0.001). Side effects were minor. In this pilot study, the use of ambroxol was associated to decreased fibromyalgia pain and improved fibromyalgia symptoms. The open nature of our study does not allow extracting the placebo effect from the positive results. The drug was well tolerated. Ambroxol newly recognized pharmacological properties could theoretically interfere with fibromyalgia pain pathways. Dose escalating-controlled studies seem warranted.

Determining the origin of cells in tissue engineered skin substitutes: a pilot study employing in situ hybridization.

PubMed

Weber, Andreas Daniel; Pontiggia, Luca; Biedermann, Thomas; Schiestl, Clemens; Meuli, Martin; Reichmann, Ernst

2011-03-01

Definitive and high-quality coverage of large and, in particular, massive skin defects remains a significant challenge in burn as well as plastic and reconstructive surgery because of donor site shortage. A novel and promising approach to overcome these problems is tissue engineering of skin. Clearly, before eventual clinical application, engineered skin substitutes of human origin must be grafted and then evaluated in animal models. For the various tests to be conducted it is indispensable to be able to identify human cells as such in culture and also to distinguish between graft and recipient tissue after transplantation. Here we describe a tool to identify human cells in vitro and in vivo. In situ hybridization allows for the detection and localization of specific DNA or RNA sequences in morphologically preserved cells in culture or tissue sections, respectively. We used digoxigenin-labeled DNA probes corresponding to human-specific Alu repeats in order to identify human keratinocytes grown in culture together with rat cells, and also to label split and full thickness skin grafts of human origin after transplantation on immuno-incompetent rats. Digoxigenin-labeled DNA probing resulted in an intensive nuclear staining of human cells, both in culture and after transplantation onto recipient animals, while recipient animal cells (rat cells) did not stain. In situ hybridization using primate-specific Alu probes reliably allows distinguishing between cells of human and non-human origin both in culture as well as in histological sections. This method is an essential tool for those preclinical experiments (performed on non-primate animals) that must be conducted before novel tissue engineered skin substitutes might be introduced into clinical practice.

Effects of supplemental vitamin D and calcium on oxidative DNA damage marker in normal colorectal mucosa: a randomized clinical trial.

PubMed

Fedirko, Veronika; Bostick, Roberd M; Long, Qi; Flanders, W Dana; McCullough, Marjorie L; Sidelnikov, Eduard; Daniel, Carrie R; Rutherford, Robin E; Shaukat, Aasma

2010-01-01

The exact antineoplastic effects of calcium and vitamin D(3) in the human colon are unclear. Animal and in vitro studies show that these two agents reduce oxidative stress; however, these findings have never been investigated in humans. To address this, we conducted a pilot, randomized, double-blind, placebo-controlled, 2 x 2 factorial clinical trial to test the effects of calcium and vitamin D(3) on a marker of oxidative DNA damage, 8-hydroxy-2'-deoxyguanosine (8-OH-dG), in the normal colorectal mucosa. Patients (N = 92) with at least one pathology-confirmed colorectal adenoma were treated with 2 g/d calcium and/or 800 IU/d vitamin D(3) versus placebo over 6 months. Overall labeling and colorectal crypt distribution of 8-OH-dG in biopsies of normal-appearing rectal mucosa were detected by standardized automated immunohistochemistry and quantified by image analysis. After 6 months of treatment, 8-OH-dG labeling along the full lengths of colorectal crypts decreased by 22% (P = 0.15) and 25% (P = 0.10) in the calcium and vitamin D(3) groups, respectively, but not in the calcium plus vitamin D(3) group. The estimated treatment effects were strongest among participants with higher baseline colon crypt vitamin D receptor expression (P = 0.05). Overall, these preliminary results indicate that calcium and vitamin D(3) may decrease oxidative DNA damage in the normal human colorectal mucosa, support the hypothesis that 8-OH-dG labeling in colorectal crypts is a treatable oxidative DNA damage biomarker of risk for colorectal neoplasms, and provide support for further investigation of calcium and vitamin D(3) as chemopreventive agents against colorectal neoplasms.

Treatment of clozapine-associated obesity and diabetes with exenatide (CODEX) in adults with schizophrenia: study protocol for a pilot randomised controlled trial.

PubMed

Mayfield, Karla; Siskind, Dan; Winckel, Karl; Hollingworth, Samantha; Kisely, Steve; Russell, Anthony W

2015-06-01

Clozapine causes significant metabolic disturbances including obesity and type 2 diabetes. Recent evidence that reduced glucagon-like-peptide-1 (GLP-1) may contribute to aetiology of clozapine-associated metabolic dysregulation suggests a potential therapeutic role for GLP-1 agonists. This open-label, pilot randomised controlled trial evaluates the effect of exenatide in clozapine-treated obese adults who have schizophrenia, with or without poorly controlled diabetes. Sixty out-patients will be randomised to once weekly extended release exenatide or treatment as usual for 24 weeks. To evaluate the feasibility of larger studies regarding methodology, acceptability, tolerability and estimate efficacy for glycaemic control or weight loss. Secondary outcomes are psychosis severity and metabolic parameters. This is the first trial investigating GLP-1 agonists for glycaemic control and weight loss in clozapine-treated patients with either diabetes or obesity. Clozapine-associated obesity and diabetes with exenatide (CODEX) will provide proof-of-concept empirical evidence addressing whether this novel treatment is practical and worthy of further investigation. A.W.R. has received speaker honoraria and travel grants from AstraZeneca, BoehringerIngelheim, Eli Lilly, MSD, Novo Nordisk and Sanofi and has participated on advisory panels for MSD and Novo Nordisk. © The Royal College of Psychiatrists 2015. This is an open access article distributed under the terms of the Creative Commons Non-Commercial, No Derivatives (CC BY-NC-ND) licence.

Oral administration of an association of forskolin, rutin and vitamins B1 and B2 potentiates the hypotonising effects of pharmacological treatments in POAG patients.

PubMed

Pescosolido, N; Librando, A

2010-01-01

Control of intraocular pressure is still the main strategy to treat glaucoma patients. Forskolin has already shown an ability to control intraocular pressure after topic administration, whereas rutin is known to improve ocular blood fl ow. Therefore, aim of this pilot study has been to observe whether administration of an association of oral forskolin and rutin to POAG patients under different regimens of medical therapy may contribute to their effects, further decreasing IOP values. Forskolin (a natural compound present in the crude extract of the plant Coleus Forskohlii) and rutin are the main ingredients of a food supplement commercially available in Italy. In an open label pilot study, 16 patients with POAG under treatment with different topical drugs and with stable IOP were given additional treatment with the food supplement for 40 days, and their IOP values measured at enrolment, at the end of treatment and 40 days after treatment interruption. Further addition of forskolin and rutin to topical association treatments resulted in a further decrease of IOP by roughly 20% of the initial value. The effect was reversible upon suspension of the treatment. These data show for the fi rst time that forskolin and rutin given through the oral route appear to reach the ocular district, where they can act in synergy with topical pharmacological treatments, and contribute to the control of intraocular pressure.

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.

'Jago Grahak Jago': A cross-sectional study to assess awareness about food adulteration in an urban slum.

PubMed

Ishwar, Shailesh; Dudeja, Puja; Shankar, Pooja; Swain, Santosh; Mukherji, Sandip

2018-01-01

Food adulteration includes various forms of practices, including mixing, substituting, concealing the quality of food, etc. One of the main causes for rampant adulteration is ignorance of consumer regarding their right and responsibilities resulting in faulty buying practices. Hence, the present study was done to assess the knowledge about adulteration among consumers in an urban slum. A community-based cross-sectional study was done among residents of an urban slum over a period of 2 months. Adults responsible for purchasing groceries for the household were included. A sample size of 100 was taken and pilot-tested questionnaire was administered. All of them were made aware about adulteration. The mean age of the study subjects was 40.2 ± 11.7 years. Only 7% of the study subjects were illiterate. Good practices like checking of Food Safety and Standards Authority of India (FSSAI) logo (90%), Agmark logo (76%) and nutrition label (65%) are lacking among the majority. The most prominent source of knowledge about adulteration is mass media especially television (65%). Almost 40% of the study subjects are unaware about the consumer empowering initiative ' Jago Grahak Jago '. Factors which had a strong positive relationship with good practices like checking of nutrition label, FSSAI logo, Agmark logo, seal and expiry date are age, education status and socio-economic status ( p value ≤ 0.05). Majority of study subjects are unaware about adulteration. ' Jago Grahak Jago ' initiative which empowers the consumers has to be instilled in the minds of consumers. Awareness and motivation will lead to empowerment and end the menace of food adulteration.

Micronutrients supplementation and nutritional status in cognitively impaired elderly persons: a two-month open label pilot study.

PubMed

von Arnim, Christine A F; Dismar, Stephanie; Ott-Renzer, Cornelia S; Noeth, Nathalie; Ludolph, Albert C; Biesalski, Hans K

2013-11-15

Malnutrition is a widespread problem in elderly people and is associated with cognitive decline. However, interventional studies have produced ambiguous results. For this reason, we wanted to determine the effect of micronutrient supplementation on blood and tissue levels and on general nutritional status in persons with mild or moderate cognitive impairment. We performed a 2-month, open-label trial, administering a daily micronutrient supplement to 42 memory clinic patients with mild cognitive deficits. Blood levels of antioxidants, zinc, and B vitamins were determined before and after supplementation. In addition, we assessed metabolic markers for B vitamins and intracellular (buccal mucosa cell [BMC]) antioxidant levels. Nutritional status was assessed by using the Mini Nutritional Assessment (MNA). Blood levels of B vitamins, folic acid, lutein, β-carotene, α-carotene, and α-tocopherol increased significantly. Decreases in homocysteine levels and the thiamine pyrophosphate effect and an increase in holotranscobalamin were observed. We found no increase in intracellular antioxidant levels of BMC. The MNA score in subjects at risk for malnutrition increased significantly, mainly owing to better perception of nutritional and overall health status. Micronutrient supplementation improved serum micronutrient status, with improved metabolic markers for B vitamins but not for intracellular antioxidant status, and was associated with improved self-perception of general health status. Our data underline the necessity of determining micronutrient status and support the use of additional assessments for general health and quality of life in nutritional supplementation trials.

Insights in Public Health

PubMed Central

Donohoe Mather, Carolyn M; McGurk, Meghan D

2014-01-01

Over half of the adults in Hawai‘i are overweight or obese, exposing them to increased risk for chronic diseases and resulting in higher health care expenses. Poor dietary habits and physical inactivity are important contributors to obesity and overweight. Because adults spend most of their waking hours at work, the workplace is an important setting for interventions to solve this growing problem. Changing the nutrition environment to support healthy eating is a recommended practice for worksite wellness interventions. Following this recommendation, the Hawai‘i State Department of Health (DOH) launched the Choose Healthy Now! Healthy Vending Pilot Project to increase access to healthy options in worksites. Choose Healthy Now! utilized an education campaign and a traffic light nutrition coding system (green = go, yellow = slow, red = uh-oh), based on federal nutrition guidelines, to help employees identify the healthier options in their worksite snack shops. Inventory of healthy items was increased and product placement techniques were used to help make the healthy choice the easy choice. DOH partnered with the Department of Human Services' Ho‘opono Vending Program to pilot the project in six government buildings on O‘ahu between May and September of 2014. Vendors added new green (healthy) and yellow (intermediate) options to their snack shop and cafeteria inventories, and labeled their snacks and beverages with green and yellow point-of-decision stickers. The following article outlines background and preliminary findings from the Choose Healthy Now! pilot. PMID:25414808

Long-term Follow-up of Psilocybin-facilitated Smoking Cessation

PubMed Central

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

2017-01-01

Background A recent open-label pilot study (N=15) found that two to three moderate to high doses (20 and 30 mg/70 kg) of the serotonin 2A receptor agonist psilocybin, in combination with cognitive behavioral therapy (CBT) for smoking cessation, resulted in substantially higher 6-month smoking abstinence rates than are typically observed with other medications or CBT alone. Objectives To assess long-term effects of a psilocybin-facilitated smoking cessation program at ≥12 months after psilocybin administration. Methods The present report describes biologically verified smoking abstinence outcomes of the previous pilot study at ≥12 months, and related data on subjective effects of psilocybin. Results All 15 participants completed a 12-month follow-up, and 12 (80%) returned for a long-term (≥16 months) follow-up, with a mean interval of 30 months (range = 16 – 57 months) between target-quit date (i.e., first psilocybin session) and long-term follow-up. At 12-month follow-up, 10 participants (67%) were confirmed as smoking abstinent. At long-term follow-up, nine participants (60%) were confirmed as smoking abstinent. At 12-month follow-up 13 participants (86.7%) rated their psilocybin experiences among the 5 most personally meaningful and spiritually significant experiences of their lives. Conclusion These results suggest that in the context of a structured treatment program, psilocybin holds considerable promise in promoting long-term smoking abstinence. The present study adds to recent and historical evidence suggesting high success rates when using classic psychedelics in the treatment of addiction. Further research investigating psilocybin-facilitated treatment of substance use disorders is warranted. PMID:27441452

Long-term follow-up of psilocybin-facilitated smoking cessation.

PubMed

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

2017-01-01

A recent open-label pilot study (N = 15) found that two to three moderate to high doses (20 and 30 mg/70 kg) of the serotonin 2A receptor agonist, psilocybin, in combination with cognitive behavioral therapy (CBT) for smoking cessation, resulted in substantially higher 6-month smoking abstinence rates than are typically observed with other medications or CBT alone. To assess long-term effects of a psilocybin-facilitated smoking cessation program at ≥12 months after psilocybin administration. The present report describes biologically verified smoking abstinence outcomes of the previous pilot study at ≥12 months, and related data on subjective effects of psilocybin. All 15 participants completed a 12-month follow-up, and 12 (80%) returned for a long-term (≥16 months) follow-up, with a mean interval of 30 months (range = 16-57 months) between target-quit date (i.e., first psilocybin session) and long-term follow-up. At 12-month follow-up, 10 participants (67%) were confirmed as smoking abstinent. At long-term follow-up, nine participants (60%) were confirmed as smoking abstinent. At 12-month follow-up 13 participants (86.7%) rated their psilocybin experiences among the five most personally meaningful and spiritually significant experiences of their lives. These results suggest that in the context of a structured treatment program, psilocybin holds considerable promise in promoting long-term smoking abstinence. The present study adds to recent and historical evidence suggesting high success rates when using classic psychedelics in the treatment of addiction. Further research investigating psilocybin-facilitated treatment of substance use disorders is warranted.

Efficacy and safety of oral alitretinoin in severe oral lichen planus--results of a prospective pilot study.

PubMed

Kunz, M; Urosevic-Maiwald, M; Goldinger, S M; Frauchiger, A L; Dreier, J; Belloni, B; Mangana, J; Jenni, D; Dippel, M; Cozzio, A; Guenova, E; Kamarachev, J; French, L E; Dummer, R

2016-02-01

Patients with severe oral lichen planus refractory to standard topical treatment currently have limited options of therapy suitable for long-term use. Oral alitretinoin (9-cis retinoic acid) was never systematically investigated in clinical trials, although case reports suggest its possible efficacy. To assess the efficacy and safety of oral alitretinoin taken at 30 mg once daily for up to 24 weeks in the treatment of severe oral lichen planus refractory to standard topical therapy. We conducted a prospective open-label single arm pilot study to test the efficacy and safety of 30 mg oral alitretinoin once daily for up to 24 weeks in severe oral lichen planus. Ten patients were included in the study. Primary end point was reduction in signs and symptoms measured by the Escudier severity score. Secondary parameters included pain and quality of life scores. Safety parameters were assessed during a follow-up period of 5 weeks. A substantial response at the end of treatment, i.e. >50% reduction in disease severity measured by the Escudier severity score, was apparent in 40% of patients. Therapy was well tolerated. Adverse events were mild and included headache, mucocutaneous dryness, musculoskeletal pain, increased thyroid-stimulating hormone and dyslipidaemia. Alitretinoin given at 30 mg daily reduced disease severity of severe oral lichen planus in a substantial proportion of patients refractory to standard treatment, was well tolerated and may thus represent one therapeutic option for this special group of patients. © 2015 European Academy of Dermatology and Venereology.

Anodal tDCS of the swallowing motor cortex for treatment of dysphagia in multiple sclerosis: a pilot open-label study.

PubMed

Cosentino, G; Gargano, R; Bonura, G; Realmuto, S; Tocco, E; Ragonese, P; Gangitano, M; Alfonsi, E; Fierro, B; Brighina, F; Salemi, G

2018-05-13

Swallowing difficulties are a common symptom of multiple sclerosis (MS). The early detection and treatment of dysphagia is critical to prevent complications, including poor nutrition, dehydration, and lung infections. Recently, transcranial direct current stimulation (tDCS) has been proven to be effective in ameliorating swallowing problems in stroke patients. In this pilot study, we aimed to assess safety and efficacy of transcranial direct current stimulation (tDCS) in the treatment of dysphagia in MS patients. We screened 30 patients by using the 10-item DYsphagia in MUltiple Sclerosis (DYMUS) questionnaire, and patients at risk for dysphagia underwent a clinical and fiberoptic endoscopic evaluation of swallowing (FEES). Six patients who presented with mild to moderate dysphagia underwent the experimental procedures. These consisted of 5 sessions of anodal tDCS applied in consecutive days over the right swallowing motor cortex. Patients were followed-up at 1 week, 1 month and 3 months after treatment, and changes in the Dysphagia Outcome and Severity Scale (DOSS) score between baseline and post-tDCS were assessed. Our results showed that in all patients, the tDCS treatment determined a mild but significant clinical benefit (one-point improvement in the DOSS score) lasting up to 1 month. In conclusion, our preliminary results show that anodal tDCS has therapeutic potential in the treatment of swallowing problems in patients suffering with MS. However, future double-blind, randomized, and sham-controlled studies are needed to confirm the present findings.

Point-of-purchase nutrition information influences food-purchasing behaviors of college students: a pilot study.

PubMed

Freedman, Marjorie R; Connors, Rachel

2010-08-01

The goal of point-of-purchase (POP) nutrition information is to help consumers make informed, healthful choices. Despite limited evaluation, these population-based approaches are being advocated to replace traditional, more expensive, individual behavior-change strategies. Few studies have examined the effect of POP information on buying patterns of college students, a group with high obesity rates and poor eating habits. This quasi-experimental pilot project sought to determine whether the "Eat Smart" POP program affected food-purchasing habits of multiethnic college students shopping at an on-campus convenience store. Baseline sales data of foods in the cereal, soup, cracker, and bread categories were collected for 6 weeks during Fall 2008. After Winter break, a few food items within each of these food categories were labeled as healthful using a "Fuel Your Life" shelf tag, and sales data were then collected for 5 weeks. In each of the four food categories, nontagged foods were available at the identical price as tagged items. Following intervention, there were increased sales of tagged items (measured as a percentage of total sales) in the cereal, soup, and cracker categories, while sales of bread decreased. Although none of these changes were statistically significant, the intervention resulted in a 3.6%+/-1.6% (P=0.082) increase in the percentage of sales from tagged items. Thus, providing POP nutrition information in a college campus convenience store may promote healthful food choices. A longer study examining the effect of POP on sales of items in other food categories is warranted. 2010 American Dietetic Association. Published by Elsevier Inc. All rights reserved.

Argon plasma coagulation treatment of anal high-grade squamous intraepithelial lesions in men who have sex with men living with HIV: results of a 2-year prospective pilot study.

PubMed

de Pokomandy, A; Rouleau, D; Lalonde, R; Beauvais, C; de Castro, C; Coutlée, F

2018-02-01

Men who have sex with men (MSM) living with HIV are at high risk for anal high-grade squamous intraepithelial lesions (HSILs) and cancer. The best management of anal HSIL remains unclear. Our objective was to assess whether argon plasma coagulation (APC) could be safe, well tolerated and efficient to treat anal HSILs in MSM living with HIV. A prospective phase II, open-label, pilot study was conducted to evaluate APC to treat anal HSILs in 20 HIV-positive MSM. Participants were followed for 2 years after their first treatment. Twenty men with persistent HSILs completed the 2-year study. Their baseline median CD4 count was 490 cells/μL and 85% had undetectable HIV viral loads. Overall, 65% (13/20) of participants were clear of HSILs at their 24-month visit. The initial response rates after the first, second and third APC treatments were 45%, 44% and 67%, respectively, but recurrences were common. The main side effect was pain during and within 1 week after the treatments. There were no long-term side effects, nor serious adverse events related to the procedure. Cost is a drawback. APC can be used to treat anal HSILs in HIV-seropositive MSM, and requires repeated treatment because of a high recurrence rate. As successful treatment of human papillomavirus (HPV) infection or eradication of the anal transitional zone remains impossible, HSIL treatment is challenging and requires long-term follow-up. © 2017 British HIV Association.

Aneurysmal SubArachnoid Hemorrhage—Red Blood Cell Transfusion And Outcome (SAHaRA): a pilot randomised controlled trial protocol

PubMed Central

English, Shane W; Fergusson, D; Chassé, M; Lauzier, F; Griesdale, D; Algird, A; Kramer, A; Tinmouth, A; Lum, C; Sinclair, J; Marshall, S; Dowlatshahi, D; Boutin, A; Pagliarello, G; McIntyre, L A

2016-01-01

Introduction Anaemia is common in aneurysmal subarachnoid haemorrhage (aSAH) and is a potential critical modifiable factor affecting secondary injury. Despite physiological evidence and management guidelines that support maintaining a higher haemoglobin level in patients with aSAH, current practice is one of a more restrictive approach to transfusion. The goal of this multicentre pilot trial is to determine the feasibility of successfully conducting a red blood cell (RBC) transfusion trial in adult patients with acute aSAH and anaemia (Hb ≤100 g/L), comparing a liberal transfusion strategy (Hb ≤100 g/L) with a restrictive strategy (Hb ≤80 g/L) on the combined rate of death and severe disability at 12 months. Methods Design This is a multicentre open-label randomised controlled pilot trial at 5 academic tertiary care centres. Population We are targeting adult aSAH patients within 14 days of their initial bleed and with anaemia (Hb ≤110 g/L). Randomisation Central computer-generated randomisation, stratified by centre, will be undertaken from the host centre. Randomisation into 1 of the 2 treatment arms will occur when the haemoglobin levels of eligible patients fall to ≤100 g/L. Intervention Patients will be randomly assigned to either a liberal (threshold: Hb ≤100 g/L) or a restrictive transfusion strategy (threshold: Hb ≤80 g/L). Outcome Primary: Centre randomisation rate over the study period. Secondary: (1) transfusion threshold adherence; (2) study RBC transfusion protocol adherence; and (3) outcome assessment including vital status at hospital discharge, modified Rankin Score at 6 and 12 months and Functional Independence Measure and EuroQOL Quality of Life Scale scores at 12 months. Outcome measures will be reported in aggregate. Ethics and dissemination The study protocol has been approved by the host centre (OHSN-REB 20150433-01H). This study will determine the feasibility of conducting the large pragmatic RCT comparing 2 RBC transfusion strategies examining the effect of a liberal strategy on 12-month outcome following aSAH. Trial registration number NCT02483351; Pre-results. PMID:27927658

A randomized, open-label pilot of the combination of low-level laser therapy and lorcaserin for weight loss.

PubMed

Croghan, Ivana T; Ebbert, Jon O; Schroeder, Darrell R; Hurt, Ryan T; Hagstrom, Victoria; Clark, Matthew M

2016-01-01

Obesity is a significant public health problem and innovative treatments are needed. The purpose of this pilot study was to assess the preliminary efficacy and safety of a combined treatment of low-level laser therapy (LLLT) and lorcaserin on weight loss, health quality of life (QOL) measures, and cardiovascular risk factors. Forty-five overweight and obese adult participants with a body mass index (BMI) >26.9 and <40 were randomized to receive LLLT, lorcaserin, or a combination of the two therapies. All study participants received treatment for 3 months and were followed for 3 months post-treatment. Participants were recruited from June 2014 through September 2014. The majority of the 44 participants accrued to this study were female (84 %) with an average age of 43.9 years (range 22 to 64 years). Most participants (93 % LLLT alone, 87 % LLLT + lorcaserin) completed at least 80 % of the LLLT treatments. From baseline to end of treatment, significant reductions in waist circumference were noted for each treatment group (-2.3 ± 4.1 cm, -6.0 ± 7.3 cm, and -4.0 ± 5.5 cm for LLLT, lorcaserin and combination respectively); however, the reduction in body weight was only significant in those receiving lorcaserin and combination treatment (-0.4 ± 1.5 kg, -1.3 ± 1.2 kg and -1.3 ± 1.3 kg). No significant differences were noted between the groups. Self-reported satisfaction was higher in the lorcaserin versus the LLLT group. This small pilot demonstrates that when combined with behavioral intervention, Lorcaserin and LLLT may be effective components of a comprehensive approach to the treatment of overweight and obesity in the clinical setting. Further studies with larger sample size and longer duration of treatment and follow-up are needed to further address efficacy. Trial registration: NCT02129608. Registered June 15, 2014.

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.

Surgical outcomes of robot-assisted rectal cancer surgery using the da Vinci Surgical System: a multi-center pilot Phase II study.

PubMed

Tsukamoto, Shunsuke; Nishizawa, Yuji; Ochiai, Hiroki; Tsukada, Yuichiro; Sasaki, Takeshi; Shida, Dai; Ito, Masaaki; Kanemitsu, Yukihide

2017-12-01

We conducted a multi-center pilot Phase II study to examine the safety of robotic rectal cancer surgery performed using the da Vinci Surgical System during the introduction period of robotic rectal surgery at two institutes based on surgical outcomes. This study was conducted with a prospective, multi-center, single-arm, open-label design to assess the safety and feasibility of robotic surgery for rectal cancer (da Vinci Surgical System). The primary endpoint was the rate of adverse events during and after robotic surgery. The secondary endpoint was the completion rate of robotic surgery. Between April 2014 and July 2016, 50 patients were enrolled in this study. Of these, 10 (20%) had rectosigmoid cancer, 17 (34%) had upper rectal cancer, and 23 (46%) had lower rectal cancer; six underwent high anterior resection, 32 underwent low anterior resection, 11 underwent intersphincteric resection, and one underwent abdominoperineal resection. Pathological stages were Stage 0 in 1 patient, Stage I in 28 patients, Stage II in 7 patients and Stage III in 14 patients. Pathologically complete resection was achieved in all patients. There was no intraoperative organ damage or postoperative mortality. Eight (16%) patients developed complications of all grades, of which 2 (4%) were Grade 3 or higher, including anastomotic leakage (2%) and conversion to open surgery (2%). The present study demonstrates the feasibility and safety of robotic rectal cancer surgery, as reflected by low morbidity and low conversion rates, during the introduction period. © The Author 2017. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

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.

Clinical usefulness of 99mTc-EDDA/HYNIC-TOC scintigraphy in oncological diagnostics: a pilot study.

PubMed

Plachcinska, Anna; Mikolajczak, Renata; Maecke, Helmut; Mlodkowska, Ewa; Kunert-Radek, Jolanta; Michalski, Andrzej; Rzeszutek, Katarzyna; Kozak, Jozek; Kusmierek, Jacek

2004-04-01

The clinical usefulness of a new 99mTc-labeled somatostatin analogue has been studied from the standpoint of oncological diagnostics. The group of patients studied included 40 individuals with diagnosed malignant neoplasms (32 primary and 8 metastatic). Among the primary tumors were 7 pituitary adenomas (5 hormonally active and 2 inactive), 1 liposarcoma, 2 carcinoids, 1 breast carcinoma, and 21 cases of lung cancer (2 small cell and 19 non-small cell) were represented. The metastatic tumors consisted of: 3 malignant melanomas, 1 pheochromocytoma, 1 prostatic cancer, 1 leiomyosarcoma, 1 pancreatic carcinoma ectopically secreting ACTH, and 1 carcinoid of the thymus. The radiopharmaceutical, 99mTc-EDDA/HYNIC-octreotide, was i.v. administered at the activity of 740-925 MBq. The imaging was comprized of a whole-body scan and single photon emission computed tomography. Positive scintigrams were obtained in 4 of 5 hormonally active pituitary adenomas, in 1 of 2 cases of carcinoid, in liposarcoma, breast cancer, and all cases of small cell (SCLC) and non-small cell lung cancer (NSCLC). The neoplastic metastases were visualized in 2 of 3 cases of melanoma and in patients with pheochromocytoma, pancreatic carcinoma secreting ACTH, and thymic carcinoid. Scintigrams were negative in both hormonally inactive pituitary adenomas, in one case of metastatic malignant melanoma, leiomyosarcoma, and in cases of metastasis from the prostatic carcinomas. The results of this pilot study indicated that 99mTc-EDDA/HYNIC-TOC is a potentially useful radiopharmaceutical for the imaging of a wide range of primary and metastatic tumors. More detailed indications for the clinical usefulness of the new tracer for the imaging of selected tumor types require studies on much larger groups of patients. Special attention should be paid to the successful imaging of all cases of NSCLC.

Quantification of cefazolin in serum and adipose tissue by ultra high performance liquid chromatography-Tandem mass spectrometry (UHPLC-MS/MS): application to a pilot study of obese women undergoing cesarean delivery.

PubMed

Lillico, Ryan; Sayre, Casey L; Sitar, Daniel S; Davies, Neal M; Baron, Cynthia M; Lakowski, Ted M

2016-09-15

Higher doses of cefazolin are required in obese patients for preoperative antibiotic prophylaxis, owing to its low lipophilicity. An ultra high performance liquid chromatography-tandem mass spectrometry method was developed to quantify cefazolin in serum and adipose tissue from 6 obese patients undergoing cesarean delivery, and using stable-isotope labeled cefazolin as an internal standard. The method has a 2μg/g lower limit of quantitation. The concentration in adipose tissue was 3.4±1.6μg/mL, which is less than half of the reported minimum inhibitory concentration of 8μg/mL for cefazolin. Serum cefazolin concentrations were more than 30-fold higher than in adipose tissue. Copyright © 2016 Elsevier B.V. All rights reserved.

[Comparative results of preimplantation genetic screening by array comparative genomic hybridization and new-generation sequencing].

PubMed

Aleksandrova, N V; Shubina, E S; Ekimov, A N; Kodyleva, T A; Mukosey, I S; Makarova, N P; Kulakova, E V; Levkov, L A; Barkov, I Yu; Trofimov, D Yu; Sukhikh, G T

2017-01-01

Aneuploidies as quantitative chromosome abnormalities are a main cause of failed development of morphologically normal embryos, implantation failures, and early reproductive losses. Preimplantation genetic screening (PGS) allows a preselection of embryos with a normal karyotype, thus increasing the implantation rate and reducing the frequency of early pregnancy loss after IVF. Modern PGS technologies are based on a genome-wide analysis of the embryo. The first pilot study in Russia was performed to assess the possibility of using semiconductor new-generation sequencing (NGS) as a PGS method. NGS data were collected for 38 biopsied embryos and compared with the data from array comparative genomic hybridization (array-CGH). The concordance between the NGS and array-CGH data was 94.8%. Two samples showed the karyotype 47,XXY by array-CGH and a normal karyotype by NGS. The discrepancies may be explained by loss of efficiency of array-CGH amplicon labeling.

Cathodal transcranial direct current stimulation in children with dystonia: a pilot open-label trial.

PubMed

Young, Scott J; Bertucco, Matteo; Sheehan-Stross, Rebecca; Sanger, Terence D

2013-10-01

Studies suggest that dystonia is associated with increased motor cortex excitability. Cathodal transcranial direct current stimulation can temporarily reduce motor cortex excitability. To test whether stimulation of the motor cortex can reduce dystonic symptoms in children, we measured tracking performance and muscle overflow using an electromyogram tracking task before and after stimulation. Of 10 participants, 3 showed a significant reduction in overflow, and a fourth showed a significant reduction in tracking error. Overflow decreased more when the hand contralateral to the cathode performed the task than when the hand ipsilateral to the cathode performed the task. Averaged over all participants, the results did not reach statistical significance. These results suggest that cathodal stimulation may allow a subset of children to control muscles or reduce involuntary overflow activity. Further testing is needed to confirm these results in a blinded trial and identify the subset of children who are likely to respond.

CHISSL: A Human-Machine Collaboration Space for Unsupervised Learning

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

Arendt, Dustin L.; Komurlu, Caner; Blaha, Leslie M.

We developed CHISSL, a human-machine interface that utilizes supervised machine learning in an unsupervised context to help the user group unlabeled instances by her own mental model. The user primarily interacts via correction (moving a misplaced instance into its correct group) or confirmation (accepting that an instance is placed in its correct group). Concurrent with the user's interactions, CHISSL trains a classification model guided by the user's grouping of the data. It then predicts the group of unlabeled instances and arranges some of these alongside the instances manually organized by the user. We hypothesize that this mode of human andmore » machine collaboration is more effective than Active Learning, wherein the machine decides for itself which instances should be labeled by the user. We found supporting evidence for this hypothesis in a pilot study where we applied CHISSL to organize a collection of handwritten digits.« less

The development and initial validation of the cyberchondria severity scale (CSS).

PubMed

McElroy, Eoin; Shevlin, Mark

2014-03-01

Cyberchondria is a form of anxiety characterised by excessive online health research. It may lead to increased levels of psychological distress, worry, and unnecessary medical expenses. The aim of the present study was to develop a psychometrically sound measure of this dimension. A sample of undergraduate students (N = 208; 64% female) completed a pilot version of the cyberchondria severity scale (CSS) along with the short form version of the depression, anxiety and stress scale (DASS-21). Exploratory factor analysis identified a correlated five factor structure that were labelled 'Compulsion', 'Distress', 'Excessiveness', 'Reassurance Seeking' and 'Mistrust of Medical Professional'. The CSS demonstrated good psychometric properties; the subscales had high internal consistency, along with good concurrent and convergent validity. The CSS may prove useful in a wide variety of future research activities. It may also facilitate the development and validation of interventions for cyberchondria. Copyright © 2014 Elsevier Ltd. All rights reserved.

Validation of Arabic and English versions of the ARSMA-II Acculturation Rating Scale.

PubMed

Jadalla, Ahlam; Lee, Jerry

2015-02-01

To translate and adapt the Acculturation Rating Scale of Mexican-Americans II (ARSMA-II) for Arab Americans. A multistage translation process followed by a pilot and a large study. The translated and adapted versions, Acculturation Rating Scale for Arabic Americans-II Arabic and English (ARSAA-IIA, ARSAA-IIE), were validated in a sample of 297 Arab Americans. Factor analyses with principal axis factoring extractions and direct oblimin rotations were used to identify the underlying structure of ARSAA-II. Factor analysis confirmed the underlying structure of ARSAA-II and produced two interpretable factors labeled as 'Attraction to American Culture' (AAmC) and 'Attraction to Arabic Culture' (AArC). The Cronbach's alphas of AAmC and AArC were .89 and .85 respectively. Findings support ARSAA-II A & E to assess acculturation among Arab Americans. The emergent factors of ARSAA-II support the theoretical structure of the original ARSMA-II tool and show high internal consistency.

Potential Therapeutic Effects of Psilocybin.

PubMed

Johnson, Matthew W; Griffiths, Roland R

2017-07-01

Psilocybin and other 5-hydroxytryptamine 2A agonist classic psychedelics have been used for centuries as sacraments within indigenous cultures. In the mid-twentieth century they were a focus within psychiatry as both probes of brain function and experimental therapeutics. By the late 1960s and early 1970s these scientific inquires fell out of favor because classic psychedelics were being used outside of medical research and in association with the emerging counter culture. However, in the twenty-first century, scientific interest in classic psychedelics has returned and grown as a result of several promising studies, validating earlier research. Here, we review therapeutic research on psilocybin, the classic psychedelic that has been the focus of most recent research. For mood and anxiety disorders, three controlled trials have suggested that psilocybin may decrease symptoms of depression and anxiety in the context of cancer-related psychiatric distress for at least 6 months following a single acute administration. A small, open-label study in patients with treatment-resistant depression showed reductions in depression and anxiety symptoms 3 months after two acute doses. For addiction, small, open-label pilot studies have shown promising success rates for both tobacco and alcohol addiction. Safety data from these various trials, which involve careful screening, preparation, monitoring, and follow-up, indicate the absence of severe drug-related adverse reactions. Modest drug-related adverse effects at the time of medication administration are readily managed. US federal funding has yet to support therapeutic psilocybin research, although such support will be important to thoroughly investigate efficacy, safety, and therapeutic mechanisms.

A tutorial on pilot studies: the what, why and how

PubMed Central

2010-01-01

Pilot studies for phase III trials - which are comparative randomized trials designed to provide preliminary evidence on the clinical efficacy of a drug or intervention - are routinely performed in many clinical areas. Also commonly know as "feasibility" or "vanguard" studies, they are designed to assess the safety of treatment or interventions; to assess recruitment potential; to assess the feasibility of international collaboration or coordination for multicentre trials; to increase clinical experience with the study medication or intervention for the phase III trials. They are the best way to assess feasibility of a large, expensive full-scale study, and in fact are an almost essential pre-requisite. Conducting a pilot prior to the main study can enhance the likelihood of success of the main study and potentially help to avoid doomed main studies. The objective of this paper is to provide a detailed examination of the key aspects of pilot studies for phase III trials including: 1) the general reasons for conducting a pilot study; 2) the relationships between pilot studies, proof-of-concept studies, and adaptive designs; 3) the challenges of and misconceptions about pilot studies; 4) the criteria for evaluating the success of a pilot study; 5) frequently asked questions about pilot studies; 7) some ethical aspects related to pilot studies; and 8) some suggestions on how to report the results of pilot investigations using the CONSORT format. PMID:20053272

Immunology in the Clinic Review Series; focus on allergies: immunotherapy for food allergy

PubMed Central

Mousallem, T; Burks, A W

2012-01-01

OTHER THEMES PUBLISHED IN THIS IMMUNOLOGY IN THE CLINIC REVIEW SERIES Metabolic Diseases, Host Responses, Cancer, Autoinflammatory Diseases, Type 1 diabetes and viruses. There is no approved therapy for food allergy. The current standard of care is elimination of the triggering food from the diet and accessibility to epinephrine. Immunotherapy is a promising treatment approach. While desensitization to most foods seems feasible, it remains unclear if a permanent state of tolerance is achievable. The research team at Duke is pioneering immunotherapy for food allergies. Work here has evolved over time from small open-label pilot studies to larger randomized designs. Our data show that immunological changes associated with immunotherapy include reduction in mast cell reactivity, decreased basophil responses, decreased specific-immunoglobulin (Ig)E, increased IgG4 and induction of regulatory T cells. Immunotherapy has generated much excitement in the food allergy community; however, further studies are needed before it is ready for clinical use. PMID:22132881

Transcranial direct current stimulation for the treatment of primary progressive aphasia: An open-label pilot study.

PubMed

Gervits, Felix; Ash, Sharon; Coslett, H Branch; Rascovsky, Katya; Grossman, Murray; Hamilton, Roy

2016-11-01

Primary progressive aphasia (PPA) is a neurodegenerative condition characterized by gradual deterioration of language function. We investigated whether two weeks of daily transcranial direct current stimulation (tDCS) treatment would improve language abilities in six people with a non-fluent form of PPA. tDCS was applied in an unblinded trial at an intensity of 1.5mA for 20min/day over 10days. At the time of stimulation, patients were engaged in narrating one of several children's wordless picture stories. A battery of neuropsychological assessments was administered four times: at baseline, immediately following the 2-week stimulation period, and then 6-weeks and 12-weeks following the end of stimulation. We observed improvement in linguistic performance in the domains of speech production and grammatical comprehension. Our encouraging results indicate that larger, sham-controlled studies of tDCS as a potential intervention for PPA are warranted. Copyright © 2016 Elsevier Inc. All rights reserved.

In vitro terahertz spectroscopy of gelatin-embedded human brain tumors: a pilot study

NASA Astrophysics Data System (ADS)

Chernomyrdin, N. V.; Gavdush, A. A.; Beshplav, S.-I. T.; Malakhov, K. M.; Kucheryavenko, A. S.; Katyba, G. M.; Dolganova, I. N.; Goryaynov, S. A.; Karasik, V. E.; Spektor, I. E.; Kurlov, V. N.; Yurchenko, S. O.; Komandin, G. A.; Potapov, A. A.; Tuchin, V. V.; Zaytsev, K. I.

2018-04-01

We have performed the in vitro terahertz (THz) spectroscopy of human brain tumors. In order to fix tissues for the THz measurements, we have applied the gelatin embedding. It allows for preserving tissues from hydration/dehydration and sustaining their THz response similar to that of the freshly-excised tissues for a long time after resection. We have assembled an experimental setup for the reflection-mode measurements of human brain tissues based on the THz pulsed spectrometer. We have used this setup to study in vitro the refractive index and the amplitude absorption coefficient of 2 samples of malignant glioma (grade IV), 1 sample of meningioma (grade I), and samples of intact tissues. We have observed significant differences between the THz responses of normal and pathological tissues of the brain. The results of this paper highlight the potential of the THz technology in the intraoperative neurodiagnosis of tumors relying on the endogenous labels of tumorous tissues.

Escitalopram treatment of pathological gambling with co-occurring anxiety: an open-label pilot study with double-blind discontinuation.

PubMed

Grant, Jon E; Potenza, Marc N

2006-07-01

Although co-occurring disorders are common in pathological gambling (PG), investigations of the response to pharmacotherapy in individuals with PG and co-occurring psychiatric symptomatology are limited. Thirteen subjects with DSM-IV PG and co-occurring anxiety were treated in a 12-week open-label trial of escitalopram. Subjects were assessed with the Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS; primary outcome measure), the Hamilton Anxiety Rating Scale (HAM-A), the Clinical Global Impressions scale (CGI), and measures of psychosocial functioning and quality of life. Those subjects who 'responded' (defined as a 30% or greater reduction in PG-YBOCS total score at endpoint) were offered inclusion in an 8-week double-blind discontinuation phase. PG-YBOCS scores decreased from a mean of 22.2+/-4.5 at baseline to 11.9+/-10.7 at endpoint (P=0.002) and 61.5% were responders. Scores on the HAM-A decreased by 82.8% over the 12-week period (mean of 15.9+/-3.2 at baseline to a mean of 2.8+/-3.6 at endpoint) (P<0.001). On the CGI, 38.5% of subjects (n=5) were 'very much improved' and 23.1% (n=3) were 'much improved' by study endpoint. The Sheehan Disability Scale, Perceive Stress Scale and Quality of Life Inventory all showed improvement (P< or = 0.001, P=0.002 and P=0.029, respectively). The mean end-of-study dose of escitalopram was 25.4+/-6.6 mg/day. Of three subjects assigned to escitalopram during the discontinuation phase, none reported statistically significant worsening of gambling symptoms. However, one subject assigned to placebo reported that gambling symptoms returned within 4 weeks. Open-label escitalopram treatment was associated with improvements in gambling and anxiety symptoms and measures of psychosocial functioning and quality of life. Larger, longer, placebo-controlled, double-blind studies are needed to evaluate further the safety and tolerability of escitalopram in the treatment of PG and co-occurring anxiety.

Investigation of flow behaviour of coal particles in a pilot-scale fluidized bed gasifier (FBG) using radiotracer technique.

PubMed

Pant, H J; Sharma, V K; Kamudu, M Vidya; Prakash, S G; Krishanamoorthy, S; Anandam, G; Rao, P Seshubabu; Ramani, N V S; Singh, Gursharan; Sonde, R R

2009-09-01

Knowledge of residence time distribution (RTD), mean residence time (MRT) and degree of axial mixing of solid phase is required for efficient operation of coal gasification process. Radiotracer technique was used to measure the RTD of coal particles in a pilot-scale fluidized bed gasifier (FBG). Two different radiotracers i.e. lanthanum-140 and gold-198 labeled coal particles (100 gm) were independently used as radiotracers. The radiotracer was instantaneously injected into the coal feed line and monitored at the ash extraction line at the bottom and gas outlet at the top of the gasifier using collimated scintillation detectors. The measured RTD data were treated and MRTs of coal/ash particles were determined. The treated data were simulated using tanks-in-series model. The simulation of RTD data indicated good degree of mixing with small fraction of the feed material bypassing/short-circuiting from the bottom of the gasifier. The results of the investigation were found useful for optimizing the design and operation of the FBG, and scale-up of the gasification process.

Effects of Açai (Euterpe oleracea Mart.) berry preparation on metabolic parameters in a healthy overweight population: a pilot study.

PubMed

Udani, Jay K; Singh, Betsy B; Singh, Vijay J; Barrett, Marilyn L

2011-05-12

The purpose of this study was to evaluate the effect of açai fruit pulp on risk factors for metabolic disorders in overweight subjects. The açaí palm (Euterpe oleracea Mart.), which is native to South America, produces a small, black-purple fruit which is edible. The fruit has recently become popular as a functional food due to its antioxidant potential. Although several studies have been conducted in vitro and with animals, little is known about the potential health benefits in humans aside from an increase in plasma anti-oxidant capacity. Metabolic syndrome is a condition which is defined by a cluster of risk factors for cardiovascular disease and/or type-2 diabetes. Preliminary studies indicate that a reduction in reactive oxygen species can assist in the normalization of the metabolic pathways involved in this syndrome. This was an open label pilot study conducted with 10 overweight adults (BMI ≥ 25 kg/m² and ≤ 30 kg/m²) who took 100 g açai pulp twice daily for 1 month. The study endpoints included levels of fasting plasma glucose, insulin, cholesterol, triglycerides, exhaled (breath) nitric oxide metabolites (eNO) and plasma levels of high sensitivity C-reactive protein (hs-CRP). The response of blood glucose, blood pressure and eNO to a standardized meal was determined at baseline and following the 30 day treatment. Compared to baseline, there were reductions in fasting glucose and insulin levels following the 30 day treatment (both p < 0.02). There was also a reduction in total cholesterol (p = 0.03), as well as borderline significant reductions in LDL-cholesterol and the ratio of total cholesterol to HDL-cholesterol (both p = 0.051). Compared to baseline, treatment with açai ameliorated the post-prandial increase in plasma glucose following the standardized meal, measured as the area under the curve (p = 0.047). There was no effect on blood pressure, hs-CRP or eNO. In this uncontrolled pilot study, consumption of açai fruit pulp reduced levels of selected markers of metabolic disease risk in overweight adults, indicating that further studies are warranted.

Effects of Açai (Euterpe oleracea Mart.) berry preparation on metabolic parameters in a healthy overweight population: A pilot study

PubMed Central

2011-01-01

Background The purpose of this study was to evaluate the effect of açai fruit pulp on risk factors for metabolic disorders in overweight subjects. The açaí palm (Euterpe oleracea Mart.), which is native to South America, produces a small, black-purple fruit which is edible. The fruit has recently become popular as a functional food due to its antioxidant potential. Although several studies have been conducted in vitro and with animals, little is known about the potential health benefits in humans aside from an increase in plasma anti-oxidant capacity. Metabolic syndrome is a condition which is defined by a cluster of risk factors for cardiovascular disease and/or type-2 diabetes. Preliminary studies indicate that a reduction in reactive oxygen species can assist in the normalization of the metabolic pathways involved in this syndrome. Methods This was an open label pilot study conducted with 10 overweight adults (BMI ≥ 25 kg/m2 and ≤ 30 kg/m2) who took 100 g açai pulp twice daily for 1 month. The study endpoints included levels of fasting plasma glucose, insulin, cholesterol, triglycerides, exhaled (breath) nitric oxide metabolites (eNO) and plasma levels of high sensitivity C-reactive protein (hs-CRP). The response of blood glucose, blood pressure and eNO to a standardized meal was determined at baseline and following the 30 day treatment. Results Compared to baseline, there were reductions in fasting glucose and insulin levels following the 30 day treatment (both p < 0.02). There was also a reduction in total cholesterol (p = 0.03), as well as borderline significant reductions in LDL-cholesterol and the ratio of total cholesterol to HDL-cholesterol (both p = 0.051). Compared to baseline, treatment with açai ameliorated the post-prandial increase in plasma glucose following the standardized meal, measured as the area under the curve (p = 0.047). There was no effect on blood pressure, hs-CRP or eNO. Conclusion In this uncontrolled pilot study, consumption of açai fruit pulp reduced levels of selected markers of metabolic disease risk in overweight adults, indicating that further studies are warranted. PMID:21569436

Status of the Local Enforcement of Energy Efficiency Standards and Labeling Program in China

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

Zhou, Nan; Zheng, Nina; Fino-Chen, Cecilia

2011-09-26

As part of its commitment to promoting and improving the local enforcement of appliance energy efficiency standards and labeling, the China National Institute of Standardization (CNIS) launched the National and Local Enforcement of Energy Efficiency Standards and Labeling project on August 14, 2009. The project’s short-term goal is to expand the effort to improve enforcement of standards and labeling requirements to the entire country within three years, with a long-term goal of perfecting overall enforcement. For this project, Jiangsu, Shandong, Sichuan and Shanghai were selected as pilot locations. This report provides information on the local enforcement project’s recent background, activitiesmore » and results as well as comparison to previous rounds of check-testing in 2006 and 2007. In addition, the report also offers evaluation on the achievement and weaknesses in the local enforcement scheme and recommendations. The results demonstrate both improvement and some backsliding. Enforcement schemes are in place in all target cities and applicable national standards and regulations were followed as the basis for local check testing. Check testing results show in general high labeling compliance across regions with 100% compliance for five products, including full compliance for all three products tested in Jiangsu province and two out of three products tested in Shandong province. Program results also identified key weaknesses in labeling compliance in Sichuan as well as in the efficiency standards compliance levels for small and medium three-phase asynchronous motors and self-ballasted fluorescent lamps. For example, compliance for the same product ranged from as low as 40% to 100% with mixed results for products that had been tested in previous rounds. For refrigerators, in particular, the efficiency standards compliance rate exhibited a wider range of 50% to 100%, and the average rate across all tested models also dropped from 96% in 2007 to 63%, possibly due to the implementation of newly strengthened efficiency standards in 2009. Areas for improvement include: Greater awareness at the local level to ensure that all manufacturers register their products with the label certification project and to minimize their resistance to inspections; improvement of the product sampling methodology to include representative testing of both large and small manufacturers and greater standardization of testing tools and procedures; and continued improvement in local enforcement efforts.« less

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.

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.

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.

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

Open-label pilot study on vitamin D₃ supplementation for antipsychotic-associated metabolic anomalies.

PubMed

Thakurathi, Neelam; Stock, Shannon; Oppenheim, Claire E; Borba, Christina P C; Vincenzi, Brenda; Seidman, Larry J; Stone, William S; Henderson, David C

2013-09-01

Previous studies have linked vitamin D deficiency to hypertension, dyslipidemia, diabetes mellitus, and cardiovascular disease. The aim of this study was to investigate the short-term effects of vitamin D₃ supplementation on weight and glucose and lipid metabolism in antipsychotic-treated patients. A total of 19 schizophrenic or schizoaffective patients (BMI>27 kg/m²) taking atypical antipsychotics were recruited and dispensed a 2000 IU daily dose of vitamin D₃. On comparing baseline with week 8 (study end) results, we found a statistically significant increase in vitamin D₃ and total vitamin D levels but no statistically significant changes in weight, glucose, or lipids measurements. Patients whose vitamin D₃ level at week 8 was 30 ng/ml or more achieved a significantly greater decrease in total cholesterol levels compared with those whose week 8 vitamin D₃ measurement was less than 30 ng/ml. These results suggest that a randomized trial with a longer follow-up period would be helpful in further evaluating the effects of vitamin D₃ on weight, lipid metabolism, and on components of metabolic syndrome in antipsychotic-treated patients.

Pharmacokinetics and Tolerability of Oral Sildenafil in Adults with Cystic Fibrosis Lung Disease

PubMed Central

Taylor-Cousar, JL; Wiley, C; Felton, LA; St Clair, C; Jones, M; Curran-Everett, D; Poch, K; Nichols, DP; Solomon, GM; Saavedra, MT; Accurso, FJ; Nick, JA

2014-01-01

Rationale Airway inflammation is central to cystic fibrosis (CF) pathophysiology. Pre-clinical models have shown that phosphodiesterase inhibitors (PDEi) like sildenafil have anti-inflammatory activity. PDEi have not been studied in CF subjects. Objectives We evaluated the pharmacokinetics, tolerability, and safety of sildenafil in subjects with CF. Sputum biomarkers were used to explore efficacy. Methods An open-label pilot study of oral sildenafil administration was conducted in adults with mild to moderate CF lung disease. Subjects received oral sildenafil 20 or 40 mg p.o. t.i.d. for 6 weeks. Measurements and Main Results Twenty subjects completed the study. Estimated elimination rate constants were statistically different in subjects with CF compared to previously published non-CF subjects. Side effects were generally mild. There were no drug-related serious adverse events. Sputum neutrophil elastase activity decreased. Conclusions Subjects with CF may eliminate sildenafil at a faster rate than non-CF subjects. Sildenafil administration was safe in subjects with CF, and decreased sputum elastase activity. Sildenafil warrants further study as an anti-inflammatory in CF. PMID:25466700

Why undertake a pilot in a qualitative PhD study? Lessons learned to promote success.

PubMed

Wray, Jane; Archibong, Uduak; Walton, Sean

2017-01-23

Background Pilot studies can play an important role in qualitative studies. Methodological and practical issues can be shaped and refined by undertaking pilots. Personal development and researchers' competence are enhanced and lessons learned can inform the development and quality of the main study. However, pilot studies are rarely published, despite their potential to improve knowledge and understanding of the research. Aim To present the main lessons learned from undertaking a pilot in a qualitative PhD study. Discussion This paper draws together lessons learned when undertaking a pilot as part of a qualitative research project. Important methodological and practical issues identified during the pilot study are discussed including access, recruitment, data collection and the personal development of the researcher. The resulting changes to the final study are also highlighted. Conclusion Sharing experiences of and lessons learned in a pilot study enhances personal development, improves researchers' confidence and competence, and contributes to the understanding of research. Implications for practice Pilots can be used effectively in qualitative studies to refine the final design, and provide the researcher with practical experience to enhance confidence and competence.

Evaluating the Impact of Menu Labeling on Food Choices and Intake

PubMed Central

Larsen, Peter D.; Agnew, Henry; Baik, Jenny; Brownell, Kelly D.

2010-01-01

Objectives. We assessed the impact of restaurant menu calorie labels on food choices and intake. Methods. Participants in a study dinner (n = 303) were randomly assigned to either (1) a menu without calorie labels (no calorie labels), (2) a menu with calorie labels (calorie labels), or (3) a menu with calorie labels and a label stating the recommended daily caloric intake for an average adult (calorie labels plus information). Food choices and intake during and after the study dinner were measured. Results. Participants in both calorie label conditions ordered fewer calories than those in the no calorie labels condition. When calorie label conditions were combined, that group consumed 14% fewer calories than the no calorie labels group. Individuals in the calorie labels condition consumed more calories after the study dinner than those in both other conditions. When calories consumed during and after the study dinner were combined, participants in the calorie labels plus information group consumed an average of 250 fewer calories than those in the other groups. Conclusions. Calorie labels on restaurant menus impacted food choices and intake; adding a recommended daily caloric requirement label increased this effect, suggesting menu label legislation should require such a label. Future research should evaluate menu labeling's impact on children's food choices and consumption. PMID:20019307

Glucose sensor-augmented continuous subcutaneous insulin infusion in patients with diabetic gastroparesis: An open-label pilot prospective study

PubMed Central

Pasricha, Pankaj J.; Tonascia, James; Parkman, Henry P.; Hamilton, Frank; Herman, William H.; Basina, Marina; Buckingham, Bruce; Earle, Karen; Kirkeby, Kjersti; Hairston, Kristen; Bright, Tamis; Rothberg, Amy E.; Kraftson, Andrew T.; Siraj, Elias S.; Subauste, Angela; Lee, Linda A.; Abell, Thomas L.; McCallum, Richard W.; Sarosiek, Irene; Nguyen, Linda; Fass, Ronnie; Snape, William J.; Vaughn, Ivana A.; Miriel, Laura A.; Farrugia, Gianrico

2018-01-01

Erratic blood glucose levels can be a cause and consequence of delayed gastric emptying in patients with diabetes. It is unknown if better glycemic control increases risks of hypoglycemia or improves hemoglobin A1c levels and gastrointestinal symptoms in diabetic gastroparesis. This study investigated the safety and potential efficacy of continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) in poorly controlled diabetes with gastroparesis. Forty-five type 1 or 2 patients with diabetes and gastroparesis and hemoglobin A1c >8% from the NIDDK Gastroparesis Consortium enrolled in a 24 week open-label pilot prospective study of CSII plus CGM. The primary safety outcome was combined numbers of mild, moderate, and severe hypoglycemic events at screening and 24 weeks treatment. Secondary outcomes included glycemic excursions on CGM, hemoglobin A1c, gastroparesis symptoms, quality-of-life, and liquid meal tolerance. Combined mild, moderate, and severe hypoglycemic events occurred similarly during the screening/run-in (1.9/week) versus treatment (2.2/week) phases with a relative risk of 1.18 (95% CI 0.85–1.64, P = 0.33). CGM time in hypoglycemia (<70 mg/dL) decreased from 3.9% to 1.8% (P<0.0001), time in euglycemia (70–180 mg/dL) increased from 44.0% to 52.0% (P = 0.02), time in severe hyperglycemia (>300 mg/dL) decreased from 14.2% to 7.0% (P = 0.005), and hemoglobin A1c decreased from 9.4±1.4% to 8.3±1.3% (P = 0.001) on CSII plus CGM. Symptom scores decreased from 29.3±7.1 to 21.9±10.2 with lower nausea/vomiting, fullness/early satiety, and bloating/distention scores (P≤0.001). Quality-of-life scores improved from 2.4±1.1 to 3.1±1.1 (P<0.0001) and volumes of liquid nutrient meals tolerated increased from 420±258 to 487±312 mL (P = 0.05) at 24 weeks. In conclusion, CSII plus CGM appeared to be safe with minimal risks of hypoglycemic events and associated improvements in glycemic control, gastroparesis symptoms, quality-of-life, and meal tolerance in patients with poorly controlled diabetes and gastroparesis. This study supports the safety, feasibility, and potential benefits of improving glycemic control in diabetic gastroparesis. PMID:29652893

Nutritional and Safety Outcomes from an Open-Label Micronutrient Intervention for Pediatric Bipolar Spectrum Disorders

PubMed Central

Gracious, Barbara; Arnold, L. Eugene; Failla, Mark; Chitchumroonchokchai, Chureeporn; Habash, Diane; Fristad, Mary A.

2013-01-01

Abstract Objective The purpose of this study was to report the safety, tolerability, and serum micronutrient concentrations and their correlations with mood changes from an 8 week pilot feasibility study of a 36 ingredient multinutrient supplement, EMPowerplus (EMP+), for pediatric bipolar spectrum disorders (BPSD). Methods Ten children ages 6–12 received EMP+ escalating from one to four capsules t.i.d., with four children increased to the maximum suggested dose, five capsules t.i.d. Outcome measures were micronutrient concentrations in serum and red blood cells, vital signs, body mass index (BMI), dietary intake (Food Frequency Questionnaire and 24 hour dietary recall interview), and mood and global functioning ratings. Results Seven children (70%) completed the study. Three (30%) terminated early for tolerability and compliance issues. Adverse effects were mild and transient, and chiefly consisted of initial insomnia or gastrointestinal (GI) upset. No differences occurred in BMI (p=0.310) or waist–hip ratio (WHR; p=0.674) pre- to postsupplementation. Four of the tested serum vitamin concentrations increased from pre- to postsupplementation: vitamin A-retinol, vitamin B6, vitamin E-α-tocopherol; and folate (all p<0.05). The increase in serum 25-OH vitamin D approached significance (p=0.063). No differences were found in dietary intake pre- to postsupplementation, suggesting that blood nutrient level increases were caused by EMP+. Conclusions In this open prospective study, short-term use of EMP+ in children with BPSD appeared safe and well-tolerated, with a side effect profile preferable to first-line psychotropic drugs for pediatric bipolar spectrum disorders. A double-blind, randomized clinical trial is feasible, appears safe, and is warranted by open-label clinical outcomes and plausible mechanisms of action, combined with documentation of increased serum concentrations of specific micronutrients. PMID:24138009

Efficacy of a standardized herbal preparation (Roidosanal®) in the treatment of hemorrhoids: A randomized, controlled, open-label multicentre study

PubMed Central

Aggrawal, Kapil; Satija, Naveen; Dasgupta, Gita; Dasgupta, Partha; Nain, Parul; Sahu, Aditya R.

2014-01-01

Background: Catechins and epicatechins are monomers of naturally occurring proanthocyanidins, which have been reported with free radical scavenging, antioxidant, antiinflammatory, antiallergic, and vasodilatory properties. Plant parts rich in proanthocyanidins have been used for years in treatment of various ano-rectal diseases. This study compares the efficacy of two herbal preparations, Daflon® 500 mg and Roidosanal®, in ameliorating the signs and symptoms associated with hemorrhoids. Objective: To evaluate the safety and to compare the efficacy of a herbal preparation, Roidosanal® versus Daflon® 500 mg, on signs and symptoms of hemorrhoidal disease. Materials and Methods: In this pilot, active controlled, open-labeled multicentre study, 73 patients with proctoscopy proven hemorrhoids (Grade I to III) were randomly assigned to receive either Roidosanal® (Gr R; n = 37) or Daflon® 500 mg (Gr D; n = 36), for 15 days, at three centers in India. Assessment of hemorrhoidal symptoms was carried out in all patients at different time points. Intent-to-treat analysis was performed for both primary and secondary endpoints. Results: Baseline characteristics were comparable between the two groups. Both products were found to be equally effective in improving the ano-rectal conditions in Grade I and Grade II hemorrhoids; however, Roidosanal® demonstrated better efficacy in patients with Grade III hemorrhoids. Hemorrhoids associated symptoms like bleeding, pain, etc., improved in both groups, although intergroup comparisons were comparable. Conclusion: Both Roidosanal® and Daflon® 500 mg were equally effective in resolving signs and symptoms of hemorrhoids. Roidosanal® can be tried as a safe and effective treatment option for treatment of hemorrhoids. Further randomized, double-blind and large multicentre studies are recommended. PMID:24948863

C2 Nerve Field Stimulation for the Treatment of Fibromyalgia: A Prospective, Double-blind, Randomized, Controlled Cross-over Study.

PubMed

Plazier, Mark; Ost, Jan; Stassijns, Gaëtane; De Ridder, Dirk; Vanneste, Sven

2015-01-01

Fibromyalgia is a condition characterized by widespread chronic pain. Due to the high prevalence and high costs, it has a substantial burden on society. Treatment results are diverse and only help a small subset of patients. C2 nerve field stimulation, aka occipital nerve stimulation, is helpful and a minimally invasive treatment for primary headache syndromes. Small C2 pilot studies seem to be beneficial in fibromyalgia. Forty patients were implanted with a subcutaneous electrode in the C2 dermatoma as part of a prospective, double-blind, randomized, controlled cross-over study followed by an open label follow up period of 6 months. The patients underwent 2 week periods of different doses of stimulation consisting of minimal (.1 mA), subthreshold, and suprathreshold (for paresthesias) in a randomized order. Twenty seven patients received a permanent implant and 25 completed the 6 month open label follow up period. During the 6 week trial phase of the study, patients had an overall decrease of 36% on the fibromyalgia impact questionnaire (FIQ), a decrease of 33% fibromyalgia pain and improvement of 42% on the impact on daily life activities and quality. These results imply an overall improvement in the disease burden, maintained at 6 months follow up, as well as an improvement in life quality of 50%. Seventy six percent of patients were satisfied or very satisfied with their treatment. There seems to be a dose-response curve, with increasing amplitudes leading to better clinical outcomes. Subcutaneous C2 nerve field stimulation seems to offer a safe and effective treatment option for selected medically intractable patients with fibromyalgia. Copyright © 2015 Elsevier Inc. All rights reserved.

Radio-photothermal therapy mediated by a single compartment nanoplatform depletes tumor initiating cells and reduces lung metastasis in the orthotopic 4T1 breast tumor model

NASA Astrophysics Data System (ADS)

Zhou, Min; Zhao, Jun; Tian, Mei; Song, Shaoli; Zhang, Rui; Gupta, Sanjay; Tan, Dongfeng; Shen, Haifa; Ferrari, Mauro; Li, Chun

2015-11-01

Tumor Initiating Cells (TICs) are resistant to radiotherapy and chemotherapy, and are believed to be responsible for tumor recurrence and metastasis. Combination therapies can overcome the limitation of conventional cancer treatments, and have demonstrated promising application in the clinic. Here, we show that dual modality radiotherapy (RT) and photothermal therapy (PTT) mediated by a single compartment nanosystem copper-64-labeled copper sulfide nanoparticles ([64Cu]CuS NPs) could suppress breast tumor metastasis through eradication of TICs. Positron electron tomography (PET) imaging and biodistribution studies showed that more than 90% of [64Cu]CuS NPs was retained in subcutaneously grown BT474 breast tumor 24 h after intratumoral (i.t.) injection, indicating the NPs are suitable for the combination therapy. Combined RT/PTT therapy resulted in significant tumor growth delay in the subcutaneous BT474 breast cancer model. Moreover, RT/PTT treatment significantly prolonged the survival of mice bearing orthotopic 4T1 breast tumors compared to no treatment, RT alone, or PTT alone. The RT/PTT combination therapy significantly reduced the number of tumor nodules in the lung and the formation of tumor mammospheres from treated 4T1 tumors. No obvious side effects of the CuS NPs were noted in the treated mice in a pilot toxicity study. Taken together, our data support the feasibility of a therapeutic approach for the suppression of tumor metastasis through localized RT/PTT therapy.Tumor Initiating Cells (TICs) are resistant to radiotherapy and chemotherapy, and are believed to be responsible for tumor recurrence and metastasis. Combination therapies can overcome the limitation of conventional cancer treatments, and have demonstrated promising application in the clinic. Here, we show that dual modality radiotherapy (RT) and photothermal therapy (PTT) mediated by a single compartment nanosystem copper-64-labeled copper sulfide nanoparticles ([64Cu]CuS NPs) could suppress breast tumor metastasis through eradication of TICs. Positron electron tomography (PET) imaging and biodistribution studies showed that more than 90% of [64Cu]CuS NPs was retained in subcutaneously grown BT474 breast tumor 24 h after intratumoral (i.t.) injection, indicating the NPs are suitable for the combination therapy. Combined RT/PTT therapy resulted in significant tumor growth delay in the subcutaneous BT474 breast cancer model. Moreover, RT/PTT treatment significantly prolonged the survival of mice bearing orthotopic 4T1 breast tumors compared to no treatment, RT alone, or PTT alone. The RT/PTT combination therapy significantly reduced the number of tumor nodules in the lung and the formation of tumor mammospheres from treated 4T1 tumors. No obvious side effects of the CuS NPs were noted in the treated mice in a pilot toxicity study. Taken together, our data support the feasibility of a therapeutic approach for the suppression of tumor metastasis through localized RT/PTT therapy. Electronic supplementary information (ESI) available: Details of methods used for radiolabeling efficiency and stability of 64Cu-labeled CuS NPs. See DOI: 10.1039/c5nr04587h

The Effects of Longitudinal Control-System Dynamics on Pilot Opinion and Response Characteristics as Determined from Flight Tests and from Ground Simulator Studies

NASA Technical Reports Server (NTRS)

Sadoff, Melvin

1958-01-01

The results of a fixed-base simulator study of the effects of variable longitudinal control-system dynamics on pilot opinion are presented and compared with flight-test data. The control-system variables considered in this investigation included stick force per g, time constant, and dead-band, or stabilizer breakout force. In general, the fairly good correlation between flight and simulator results for two pilots demonstrates the validity of fixed-base simulator studies which are designed to complement and supplement flight studies and serve as a guide in control-system preliminary design. However, in the investigation of certain problem areas (e.g., sensitive control-system configurations associated with pilot- induced oscillations in flight), fixed-base simulator results did not predict the occurrence of an instability, although the pilots noted the system was extremely sensitive and unsatisfactory. If it is desired to predict pilot-induced-oscillation tendencies, tests in moving-base simulators may be required. It was found possible to represent the human pilot by a linear pilot analog for the tracking task assumed in the present study. The criterion used to adjust the pilot analog was the root-mean-square tracking error of one of the human pilots on the fixed-base simulator. Matching the tracking error of the pilot analog to that of the human pilot gave an approximation to the variation of human-pilot behavior over a range of control-system dynamics. Results of the pilot-analog study indicated that both for optimized control-system dynamics (for poor airplane dynamics) and for a region of good airplane dynamics, the pilot response characteristics are approximately the same.

76 FR 70152 - Pilot Program for Early Feasibility Study Investigational Device Exemption Applications

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-10

...] Pilot Program for Early Feasibility Study Investigational Device Exemption Applications AGENCY: Food and... feasibility study investigational device exemption (IDE) applications. The pilot program will conform to the... Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies.'' Under the pilot...

Usefulness of skin immunofluorescence for distinguishing SLE from SLE-like renal lesions: a pilot study.

PubMed

L'Erario, Ines; Frezzolini, Alessandra; Ruggiero, Barbara; De Pità, Ornella; Emma, Francesco; Gianviti, Alessandra

2011-01-01

Lupus nephritis (LN) may represent a diagnostic problem, particularly in pediatric patients that present with typical histological lesions but do not fulfill the American Rheumatism Association (ARA) criteria for the diagnosis of systemic lupus erythematosus (SLE). Based on the well-described deposition of immunoglobulins (Ig) and complement at the dermoepithelial junction in SLE, we hypothesized that skin biopsies may help in the diagnosis of LN. To test this hypothesis, we carried out a pilot study, performing a skin biopsy in 22 patients with LN and 13 patients with lupus-like lesions, regardless of the time elapsed from onset of renal disease. The latter group of patients was further divided into a purely renal group, designated as isolated full-house nephropathy (FHN), and a dubious cases group, presenting with additional clinical and biological features consistent with SLE but insufficient for diagnosing SLE. None of the 6 isolated FHN patients had positive skin immunofluorescence. Conversely, 5/7 patients in the dubious cases group (p<0.02) and 13/22 in the LN group (p<0.002) had positive staining for C1q, and 5/7 patients in the dubious cases group (p<0.02) and 16/22 patients in the LN group (p<0.001) had positive staining for IgM. No correlation was observed with the time elapsed from the initial diagnosis. These data suggest that skin biopsies may help distinguishing LN from isolated FHN. In addition, they identify an intermediate group of patients with evidence of systemic involvement despite the absence of a sufficient number of ARA criteria to be labeled as SLE.

Replicating human expertise of mechanical ventilation waveform analysis in detecting patient-ventilator cycling asynchrony using machine learning.

PubMed

Gholami, Behnood; Phan, Timothy S; Haddad, Wassim M; Cason, Andrew; Mullis, Jerry; Price, Levi; Bailey, James M

2018-06-01

- Acute respiratory failure is one of the most common problems encountered in intensive care units (ICU) and mechanical ventilation is the mainstay of supportive therapy for such patients. A mismatch between ventilator delivery and patient demand is referred to as patient-ventilator asynchrony (PVA). An important hurdle in addressing PVA is the lack of a reliable framework for continuously and automatically monitoring the patient and detecting various types of PVA. - The problem of replicating human expertise of waveform analysis for detecting cycling asynchrony (i.e., delayed termination, premature termination, or none) was investigated in a pilot study involving 11 patients in the ICU under invasive mechanical ventilation. A machine learning framework is used to detect cycling asynchrony based on waveform analysis. - A panel of five experts with experience in PVA evaluated a total of 1377 breath cycles from 11 mechanically ventilated critical care patients. The majority vote was used to label each breath cycle according to cycling asynchrony type. The proposed framework accurately detected the presence or absence of cycling asynchrony with sensitivity (specificity) of 89% (99%), 94% (98%), and 97% (93%) for delayed termination, premature termination, and no cycling asynchrony, respectively. The system showed strong agreement with human experts as reflected by the kappa coefficients of 0.90, 0.91, and 0.90 for delayed termination, premature termination, and no cycling asynchrony, respectively. - The pilot study establishes the feasibility of using a machine learning framework to provide waveform analysis equivalent to an expert human. Copyright © 2018 Elsevier Ltd. All rights reserved.

Intermittent therapy with terbinafine and nail abrasion for dermatophyte toe onychomycosis: a pilot study.

PubMed

Succi, Isabella B; Bernardes-Engemann, Andréa R; Orofino-Costa, Rosane

2013-05-01

Onychomycosis constitutes up to 50% of all nail disorders. Toenails are generally affected, mostly due to dermatophytes. Terbinafine is the most potent antifungal agent in vitro against dermatophytes. There are few randomised controlled trials using a non-continuous dose of terbinafine. The aim of this open-label pilot study was to reduce the total drug amount, the collateral effects and, specially, the costs; albeit maintaining the same efficacy of the standard regimens. Compare the outcomes of two different intermittent regimens with the same total amount of the medication (42 tablets in 6 months). Forty-one patients were divided into the following groups: terbinafine 250 mg day(-1) , for 7 days, monthly or terbinafine 500 mg day(-1) , once daily, for 7 days, every 2 months, both plus nail abrasion during 6 months. The efficacy was evaluated at months 6, 12 and 18 using the disease free nail criteria. Total cure = group I: eight patients (44.4%) and group II: eight patients (44.4%). Partial cure = group I: five patients (27.8%) and group II: four patients (22.2%). Treatment failure = group I: five patients (27.8%) and group II: three patients (16.7%). Recurrence = group I: zero patients (0.0%) and group II: three patients (16.7%). Two intermittent dosing regimens of terbinafine plus nail abrasion proved to be an alternative statistically effective, safe and with reduced drug costs for dermatophytes toenail onychomycosis. © 2012 Blackwell Verlag GmbH.

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.

A Study of the Characteristics of Human-Pilot Control Response to Simulated Aircraft Lateral Motions

NASA Technical Reports Server (NTRS)

Cheatham, Donald C

1954-01-01

Report presents the results of studies made in an attempt to provide information on the control operations of the human pilot. These studies included an investigation of the ability of pilots to control simulated unstable yawing oscillations, a study of the basic characteristics of human-pilot control response, and a study to determine whether and to what extent pilot control response can be represented in an analytical form.

[Development and validation of the Korean patient safety culture scale for nursing homes].

PubMed

Yoon, Sook Hee; Kim, Byungsoo; Kim, Se Young

2013-06-01

The purpose of this study was to develop a tool to evaluate patient safety culture in nursing homes and to test its validity and reliability. A preliminary tool was developed through interviews with focus group, content validity tests, and a pilot study. A nationwide survey was conducted from February to April, 2011, using self-report questionnaires. Participants were 982 employees in nursing homes. Data were analyzed using Cronbach's alpha, item analysis, factor analysis, and multitrait/multi-Item analysis. From the results of the analysis, 27 final items were selected from 49 items on the preliminary tool. Items with low correlation with total scale were excluded. The 4 factors sorted by factor analysis contributed 63.4% of the variance in the total scale. The factors were labeled as leadership, organizational system, working attitude, management practice. Cronbach's alpha for internal consistency was .95 and the range for the 4 factors was from .86 to .93. The results of this study indicate that the Korean Patient Safety Culture Scale has reliability and validity and is suitable for evaluation of patient safety culture in Korean nursing homes.

Social Context and Perspectives of Non-Medical Prescription Opioid Use Among Young Adults in Rhode Island: A Qualitative Study

PubMed Central

Yedinak, Jesse L.; Kinnard, Elizabeth N.; Hadland, Scott E.; Green, Traci C.; Clark, Melissa A.; Marshall, Brandon D.L.

2017-01-01

Background and Objectives This pilot study examined the context of nonmedical prescription opioid (NMPO) use and related risk behaviors among young adults in Rhode Island, a New England region with markedly high prevalence of NMPO use and overdose mortality. Methods We conducted semi-structured interviews (n = 13) with young adults (18–29 year-olds) who reported current or recent NMPO use. We also conducted focus groups (two groups, n =14 total) with professional service providers recruited from service organizations. Data were audio-recorded, transcribed, and key themes were analyzed. Results Participants discussed high levels of access to prescription opioids for nonmedical use via prescriptions originally provided to family and friends. The contexts described by participants included social environments such as parties, in which mixing opiates with benzodiazepines, alcohol or other types of drugs, and incidents of unintentional overdose were reported. Participants attributed risk for overdose to individual-level factors (eg, users who “couldn’t handle it”), rather than contextual factors, and described negative reactions to being labeled as an “addict” or “addicted.” Professional service providers had first-hand experience with young adults in treatment settings, yet limited exposure to young adults who were treatment-naïve. Conclusions Young adult NMPO users described social settings where polysubstance use and pill use were common, and highlighted an aversion to being labeled as having a substance use disorder. Scientific Significance To reduce harms of NMPO use among young adults, interventions should address the social context in which drug use and risk behaviors occur. PMID:28051839

Pilot Certification, Age of Pilot, and Drug Use in Fatal Civil Aviation Accidents.

PubMed

Akparibo, Issaka Y; Stolfi, Adrienne

2017-10-01

This study examined the association between mean age of pilot, pilot license, pilot medical certificate and drug use trends in pilots fatally injured in aircraft accidents. The prevalence of prescription drugs, OTC drugs, controlled drugs and drugs that may be potentially impairing was also examined. This study was a descriptive observational study in which the NTSB Aviation Accident Database was searched from the period beginning January 1, 2012 to December 31, 2014. During the study period a total of 706 accidents involving 711 fatalities were investigated by the NTSB. This study included 633 of these accidents, involving 646 fatalities. Of these pilots, 42.1% had drugs in their biological samples. The prevalence of prescription drugs, controlled drugs, OTC drugs, opioids, and potentially impairing drugs in the fatally injured pilot population over the study period was 28.9%, 15.0%, 20.1%, 5.1%, and 25.5%, respectively. Pilots with any drugs in their samples were significantly older than those without drugs. Medical certificate held was associated with drug use; pilots who held third class certificates had the highest prevalence at 54.1%. Pilot license was not associated with drug use. In 3.8% of the accidents, drugs were a contributing factor in the cause. Despite current FAA medical regulations, potentially impairing drugs are frequently found in biological samples of fatally injured pilots in the U.S. More education of airmen by aviation medical examiners is needed on the safety of drug use.Akparibo IY, Stolfi A. Pilot certification, age of pilot, and drug use in fatal civil aviation accidents. Aerosp Med Hum Perform. 2017; 88(10):931-936.

Safety and tolerability of low-dose naltrexone therapy in children with moderate to severe Crohn's disease: a pilot study.

PubMed

Smith, Jill P; Field, Douglas; Bingaman, Sandra I; Evans, Robert; Mauger, David T

2013-04-01

There is an unmet need for safe and effective medicines to treat children with Crohn's disease. Recently, investigations have shown an association between endogenous opioid peptides and inflammatory cells. The aims of this study were to evaluate the safety and tolerability of an opioid antagonist, naltrexone, in children with moderate to severe Crohn's disease. A pilot clinical trial was conducted in children with moderate to severe Crohn's disease. Fourteen subjects with a mean age of 12.3 years (range, 8 to 17 y) were enrolled. Children were randomized to placebo or naltrexone (0.1 mg/kg) orally for 8 weeks followed by open-labeled treatment with 8 additional weeks of naltrexone. Safety and toxicity were monitored by physical examinations and blood chemistries. Clinical activity was assessed by the Pediatric Crohn's Disease Activity Index (PCDAI) and Quality of life was monitored by the Impact III survey. Oral naltrexone was well tolerated without any serious adverse events in children with moderate to severe Crohn's disease. PCDAI scores significantly decreased from pretreatment values (34.2±3.3) with an 8-week course of naltrexone therapy (21.7±3.9) (P=0.005). Twenty-five percent of those treated with naltrexone were considered in remission (score ≤10) and 67% had improved with mild disease activity (decrease in PCDAI score by at least 10 points) at the end of the study. Systemic and social quality of life improved with naltrexone treatment (P=0.035). Naltrexone therapy seems safe with limited toxicity when given to children with Crohn's disease and may reduce disease activity.

SAFETY AND TOLERABILITY OF LOW DOSE NALTREXONE THERAPY IN CHILDREN WITH MODERATE TO SEVERE CROHN’S DISEASE: A PILOT STUDY

PubMed Central

Smith, Jill P.; Field, Douglas; Bingaman, Sandra; Evans, Robert; Mauger, David

2012-01-01

Background There is an unmet need for safe and effective medicines to treat children with Crohn’s disease. Recently, investigations have shown an association between endogenous opioid peptides and inflammatory cells. Aims The aims of this study were to evaluate the safety and tolerability of an opioid antagonist, naltrexone, in children with moderate to severe Crohn’s disease. Methods A pilot clinical trial was conducted in children with moderate to severe Crohn’s disease. Fourteen subjects with a mean age of 12.3 years (8–17, range) were enrolled. Children were randomized to placebo or naltrexone 0.1 mg/kg orally for 8 weeks followed by open-labeled treatment with 8 additional weeks of naltrexone. Safety and toxicity were monitored by physical examinations and blood chemistries. Clinical activity was assessed by the PCDAI (Pediatric Crohn’s Disease Activity Index) and Quality of life was monitored by the Impact III survey. Results Oral naltrexone was well tolerated without any serious adverse events in children with moderate to severe Crohn’s disease. PCDAI scores significantly decreased from pretreatment values (34.2±3.3) with an eight-week course of naltrexone therapy (21.7±3.9) (p=0.005). Twenty-five percent of those treated with naltrexone were considered in remission (score < 10) and 67% had improved with mild disease activity (decrease PCDAI score by at least 10 points) at the end of the study. Systemic and social quality of life improved with naltrexone treatment (p=0.035). Conclusions Naltrexone therapy appears safe with limited toxicity when given to children with Crohn’s disease and may reduce disease activity. PMID:23188075

Esophageal Motility and Rikkunshito Treatment for Proton Pump Inhibitor-Refractory Nonerosive Reflux Disease: A Prospective, Uncontrolled, Open-Label Pilot Study Trial.

PubMed

Odaka, Takeo; Yamato, Shigeru; Yokosuka, Osamu

2017-01-01

Only a few reports focused on esophageal motility in patients with proton pump inhibitor (PPI)-refractory nonerosive reflux disease (NERD) and there has been no established strategy for treatment. To clarify the characteristics of esophageal motility in patients with PPI-refractory NERD, we evaluated esophageal function using combined multichannel intraluminal impedance and esophageal manometry (MII-EM). In addition, we evaluated the efficacy of rikkunshito (RKT), which is a gastrointestinal prokinetic agent. Thirty patients with NERD were enrolled and underwent MII-EM. After 8 weeks of RKT (7.5 g/d) treatment, MII-EM was repeated on patients with PPI-refractory NERD. Symptoms were assessed by the Gastrointestinal Symptom Rating Scale. In patients with PPI-refractory NERD, measures of complete bolus transit, peristaltic contractions, and residual pressure of the lower esophageal sphincter during swallowing deviated from the standard values and esophageal clearance was found to be deteriorated. RKT significantly improved the peristaltic contractions ( P < 0.05), the complete bolus transit ( P < 0.01), and the residual pressure of lower esophageal sphincter ( P < 0.05) in these patients. The overall score ( P < 0.01) and the subscale scores of acid reflux syndrome ( P < 0.05), abdominal pain ( P < 0.05), and indigestion syndrome ( P < 0.01) in the Gastrointestinal Symptom Rating Scale were significantly improved by the 8-week RKT treatment. In the pilot study, patients with PPI-refractory NERD had disorders of esophageal and lower esophageal sphincter motility that were improved by RKT. Further studies examining esophageal motor activity of RKT in PPI-refractory NERD are required. University hospital Medical Information Network (UMIN) Clinical Trial Registry identifier: UMIN000003092.

Beneficial effects of a Coriolus versicolor-based vaginal gel on cervical epithelization, vaginal microbiota and vaginal health: a pilot study in asymptomatic women.

PubMed

Palacios, Santiago; Losa, Fernando; Dexeus, Damián; Cortés, Javier

2017-03-16

To assess the effect of a 12-day treatment using a vaginal gel based on niosomes containing hyaluronic acid, ß-glucan, alpha-glucan oligosaccharide, Coriolus versicolor, Asian centella, Azadirachta indica and Aloe vera on vaginal microbiota, cervical epithelization and vaginal health. Open-label, prospective pilot study conducted in asymptomatic women in daily practice. Cervical epithelization was evaluated by colposcopy using an ectopy epithelization score (from 5: no ectopy to 1: severe ectopy and bleeding), vaginal microbiota using the VaginaStatus-Diagnostic test (Instiüt für Mikroökologie, Herborn, Germany) and further rated by the investigator using a 5-point Liker scale (from 5: normal to 1: very severe deterioration in which all evaluated species were altered), and vaginal health using the Vaginal Health Index. In 21 women, a positive effect to improve epithelization of the cervical mucosa, with a mean score of 4.42 at the final visit as compared to 3.09 at baseline (P < 0.0001) (43% improvement). In 10 women, there was a trend of improving of vaginal microbiota status, with a mean score of 4.0 at the final visit vs. 3.3 at baseline (P = NS) (21.2% improvement). In 11 women, the Vaginal Health Index increased from 19.0 at baseline to 22.3 at the final visit (P = 0.007). The concentration of Lactobacillus spp. increased 54.5% of women and pH decreased from 4.32 to 4.09. These encouraging preliminary results provide the basis for designing a randomized controlled study, and for potential use in human papilloma virus infection. ISRCTN77955077 . Registration date: February 15, 2017. Retrospectively registered.

Point-of-purchase nutrition information influences food-purchasing behaviors of college students: a pilot study.

PubMed

Freedman, Marjorie R; Connors, Rachel

2011-05-01

The goal of point-of-purchase (POP) nutrition information is to help consumers make informed, healthful choices. Despite limited evaluation, these population-based approaches are being advocated to replace traditional, more expensive, individual behavior-change strategies. Few studies have examined the effect of POP information on buying patterns of college students, a group with high obesity rates and poor eating habits. This quasi-experimental pilot project sought to determine whether the "Eat Smart" POP program affected food-purchasing habits of multiethnic college students shopping at an on-campus convenience store. Baseline sales data of foods in the cereal, soup, cracker, and bread categories were collected for 6 weeks during Fall 2008. After Winter break, a few food items within each of these food categories were labeled as healthful using a "Fuel Your Life" shelf tag, and sales data were then collected for 5 weeks. In each of the four food categories, nontagged foods were available at the identical price as tagged items. Following intervention, there were increased sales of tagged items (measured as a percentage of total sales) in the cereal, soup, and cracker categories, while sales of bread decreased. Although none of these changes were statistically significant, the intervention resulted in a 3.6%±1.6% (P=0.082) increase in the percentage of sales from tagged items. Thus, providing POP nutrition information in a college campus convenience store may promote healthful food choices. A longer study examining the effect of POP on sales of items in other food categories is warranted. Copyright © 2011 American Dietetic Association. Published by Elsevier Inc. All rights reserved.

Odon device for instrumental vaginal deliveries: results of a medical device pilot clinical study.

PubMed

Schvartzman, Javier A; Krupitzki, Hugo; Merialdi, Mario; Betrán, Ana Pilar; Requejo, Jennifer; Nguyen, My Huong; Vayena, Effy; Fiorillo, Angel E; Gadow, Enrique C; Vizcaino, Francisco M; von Petery, Felicitas; Marroquin, Victoria; Cafferata, María Luisa; Mazzoni, Agustina; Vannevel, Valerie; Pattinson, Robert C; Gülmezoglu, A Metin; Althabe, Fernando; Bonet, Mercedes

2018-03-12

A prolonged and complicated second stage of labour is associated with serious perinatal complications. The Odon device is an innovation intended to perform instrumental vaginal delivery presently under development. We present an evaluation of the feasibility and safety of delivery with early prototypes of this device from an early terminated clinical study. Hospital-based, multi-phased, open-label, pilot clinical study with no control group in tertiary hospitals in Argentina and South Africa. Multiparous and nulliparous women, with uncomplicated singleton pregnancies, were enrolled during the third trimester of pregnancy. Delivery with Odon device was attempted under non-emergency conditions during the second stage of labour. The feasibility outcome was delivery with the Odon device defined as successful expulsion of the fetal head after one-time application of the device. Of the 49 women enrolled, the Odon device was inserted successfully in 46 (93%), and successful Odon device delivery as defined above was achieved in 35 (71%) women. Vaginal, first and second degree perineal tears occurred in 29 (59%) women. Four women had cervical tears. No third or fourth degree perineal tears were observed. All neonates were born alive and vigorous. No adverse maternal or infant outcomes were observed at 6-weeks follow-up for all dyads, and at 1 year for the first 30 dyads. Delivery using the Odon device is feasible. Observed genital tears could be due to the device or the process of delivery and assessment bias. Evaluating the effectiveness and safety of the further developed prototype of the BD Odon Device™ will require a randomized-controlled trial. ANZCTR ACTRN12613000141741 Registered 06 February 2013. Retrospectively registered.

Efficacy of bolus lukewarm saline and yoga postures as colonoscopy preparation: a pilot study.

PubMed

Arya, Vijaypal; Gupta, Kalpana A; Arya, Swarn V

2010-12-01

Colonoscopy is now the gold standard for colon cancer screening and a vital diagnostic and therapeutic tool in 21st century medical practice. Although advances have been swift since colonoscopy came into wide use a generation ago, its effectiveness can be compromised by patients' ability to adequately prepare for the procedure. Many patients dread this task more than the procedure itself. While no prep regimen can be ideal for all patients, the authors present a novel approach that represents a potential time-saving improvement for younger, healthier patients. It is a modern version of an Indian practice called shankh prakshalana, in which lukewarm saline is used in combination with five yoga postures to cleanse the bowel. The objective of this study was to examine the safety, efficacy, and tolerability of lukewarm saline and yoga (LWS/yoga) as a colonoscopy preparation in comparison with NuLytely(®) (PEG-3350, sodium chloride, sodium bicarbonate, and potassium chloride solution) used according to the manufacturer's instructions. This was a pilot study comprising 54 healthy adults, ages 18-65, equally divided into two groups: Group A preparing with lukewarm saline and yoga postures (LWS/yoga); and Group B preparing with NuLytely(®) as directed on the label. Data were collected on the quality of bowel preparation, patient safety, patient tolerability, and side-effects. The setting was a Joint Commission accredited outpatient endoscopy clinic. Patients performed the series of five yoga postures known as shankh prakshalana, interrupting the exercises at regular intervals to consume 480 mL of lukewarm saline. The solution was prepared by adding 9 g of sodium chloride per liter of lukewarm water (99°F-102°F/37.2°C-38.9°C). The mean total score was significantly better in Group A versus Group B (20.63 ± 5.09 versus 16.48 ± 5.18, p < 0.0007). In Group A, 24/27 (88.9%) of patients had excellent or optimum total scores, compared with 21/27 (77.8%) in Group B (not significant). In our pilot study, LWS/yoga, used under supervision, produced better colon preparation than Nulytely, used as directed. A randomized, endoscopist-blinded study is needed to confirm these results. Shankh prakshalana is effective as a colonoscopy preparation.

Subjective Responses to Emotional Stimuli During Labeling, Reappraisal, and Distraction

PubMed Central

Lieberman, Matthew D.; Inagaki, Tristen K.; Tabibnia, Golnaz; Crockett, Molly J.

2011-01-01

Although multiple neuroimaging studies suggest that affect labeling (i.e., putting feelings into words) can dampen affect-related responses in the amygdala, the consequences of affect labeling have not been examined in other channels of emotional responding. We conducted four studies examining the effect of affect labeling on self-reported emotional experience. In study one, self-reported distress was lower during affect labeling, compared to passive watching, of negative emotional pictures. Studies two and three added reappraisal and distraction conditions, respectively. Affect labeling showed similar effects on self-reported distress as both of these intentional emotion regulation strategies. In each of the first three studies, however, participant predictions about the effects of affect labeling suggest that unlike reappraisal and distraction, people do not believe affect labeling to be an effective emotion regulation strategy. Even after having the experience of affect labels leading to lower distress, participants still predicted that affect labeling would increase distress in the future. Thus, affect labeling is best described as an incidental emotion regulation process. Finally, study four employed positive emotional pictures and here, affect labeling was associated with diminished self-reported pleasure, relative to passive watching. This suggests that affect labeling tends to dampen affective responses in general, rather than specifically alleviating negative affect. PMID:21534661

A nonrandomized, open-label study to evaluate the effect of nasal stimulation on tear production in subjects with dry eye disease.

PubMed

Friedman, Neil J; Butron, Karla; Robledo, Nora; Loudin, James; Baba, Stephanie N; Chayet, Arturo

2016-01-01

Dry eye disease (DED), a chronic disorder affecting the tear film and lacrimal functional unit, is a widely prevalent condition associated with significant burden and unmet treatment needs. Since specific neural circuits play an important role in maintaining ocular surface health, microelectrical stimulation of these pathways could present a promising new approach to treating DED. This study evaluated the efficacy and safety of nasal electrical stimulation in patients with DED. This prospective, open-label, single-arm, nonrandomized pilot study included 40 patients with mild to severe DED. After undergoing two screening visits, enrolled subjects were provided with a nasal stimulation device and instructed to use it at home four times daily (or more often as needed). Follow-up assessments were conducted up to day 180. The primary efficacy endpoint was the difference between unstimulated and stimulated tear production quantified by Schirmer scores. Additional efficacy endpoints included change from baseline in corneal and conjunctival staining, symptoms evaluated on a Visual Analog Scale, and Ocular Surface Disease Index scores. Safety parameters included adverse event (AE) rates, visual acuity, intraocular pressure, slit-lamp biomicroscopy, indirect ophthalmoscopy, and endoscopic nasal examinations. Mean stimulated Schirmer scores were significantly higher than the unstimulated scores at all visits, and corneal and conjunctival staining and symptom scores from baseline to day 180 were significantly reduced. No serious device-related AEs and nine nonserious AEs (three device-related) were reported. Intraocular pressure remained stable and most subjects showed little or no change in visual acuity at days 30 and 180. No significant findings from other clinical examinations were noted. Neurostimulation of the nasolacrimal pathway is a safe and effective means of increasing tear production and reducing symptoms of dry eye in patients with DED.

Impact of acamprosate on behavior and brain-derived neurotrophic factor: an open-label study in youth with fragile X syndrome.

PubMed

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

2013-07-01

Fragile X syndrome (FXS) is an inherited form of developmental disability and a single gene cause of autism. As a disorder with increasingly understood pathophysiology, FXS is a model form of developmental disability for targeted drug development efforts. Preclinical animal model findings have focused targeted drug treatment development in FXS on an imbalance between excessive glutamate and deficient gamma-aminobutyric acid (GABA) neurotransmission. We conducted a prospective open-label 10-week trial of acamprosate in 12 youth aged 6-17 years (mean age: 11.9 years) with FXS. Acamprosate use (mean dose: 1,054  ±  422 mg/day) was associated with treatment response (defined by a Clinical Global Impressions Improvement (CGI-I) scale score of "very much improved" or "much improved") in nine of 12 (75 %) subjects. Improvement was noted in social behavior and inattention/hyperactivity using multiple standard behavioral outcome measures. No significant adverse effects or changes in vital signs, including weight or laboratory measures, occurred during treatment with acamprosate. Additionally, pre- and post-treatment blood biomarker analyses looking at brain-derived neurotrophic factor (BDNF) levels found a significant increase in BDNF with treatment. In our pilot sample, treatment response did not correlate with change in BDNF with treatment. Acamprosate was generally safe and well tolerated and was associated with a significant improvement in social behavior and a reduction in inattention/hyperactivity. The increase in BDNF that occurred with treatment may be a useful pharmacodynamic marker in future acamprosate studies. Given these findings, a double-blind, placebo-controlled study of acamprosate in youth with FXS is warranted.

The Efficacy and Safety of Azelaic Acid 15% Foam in the Treatment of Truncal Acne Vulgaris.

PubMed

Hoffman, Lauren K; Del Rosso, James Q; Kircik, Leon H

2017-06-01

INTRODUCTION: Truncal acne is often associated with facial acne, but there are fewer options for an effective topical treatment on the trunk. Given the advent of foam formulations with enhanced percutaneous absorption and convenient application due to easy spreadability on skin, the previously held idea that effective treatment of truncal acne requires oral treatment is challenged. Azelaic acid cream has been previously approved for acne vulgaris, thus azelaic acid foam may be a viable treatment option for truncal acne.

STUDY DESIGN: A single-center, open label pilot study was conducted to investigate the efficacy and safety of azelaic acid 15% foam as a treatment modality for moderate truncal acne. Use for facial acne was also allowed and monitored during the study.

RESULTS: Twice-daily application of azelaic acid 15% foam to affected areas resulted in a 1-grade reduction in truncal investigator global assessment (IGA) scores in nearly all patients (16/18). Eight out of 18 patients (44%) were rated as Clear or Almost Clear in the trunk by the end of the study. There were also improvements in facial IGA scores; 9 of 18 patients (50%) exhibited a 1-grade improvement in IGA scores and 11 of 18 were Clear or Almost Clear by the end of the study. A significant reduction in lesion counts was found throughout the study and the medication was well tolerated.

CONCUSION: Azelaic acid 15% foam was effective in treating moderate truncal acne and facial acne in this pilot study. Given the efficacy and convenience of the foam vehicle, azelaic acid may be considered as a viable option for treatment of acne vulgaris, including on the trunk. Further studies are suggested in a larger population of patients, including adult females with acne.

J Drugs Dermatol. 2017;16(6):534-538.

Pilot-model analysis and simulation study of effect of control task desired control response

NASA Technical Reports Server (NTRS)

Adams, J. J.; Gera, J.; Jaudon, J. B.

1978-01-01

A pilot model analysis was performed that relates pilot control compensation, pilot aircraft system response, and aircraft response characteristics for longitudinal control. The results show that a higher aircraft short period frequency is required to achieve superior pilot aircraft system response in an altitude control task than is required in an attitude control task. These results were confirmed by a simulation study of target tracking. It was concluded that the pilot model analysis provides a theoretical basis for determining the effect of control task on pilot opinions.

SUPERFUND TREATABILITY CLEARINGHOUSE: SOIL STABILIZATION PILOT STUDY, UNITED CHROME NPL SITE PILOT STUDY AND HEALTH AND SAFETY PROGRAM, UNITED CHROME NPL SITE PILOT STUDY

EPA Science Inventory

This document is a project plan for a pilot study at the United Chrome NPL site, Corvallis, Oregon and includes the health and safety and quality assurance/quality control plans. The plan reports results of a bench-scale study of the treatment process as iieasured by the ...

Review of nutrition labeling formats.

PubMed

Geiger, C J; Wyse, B W; Parent, C R; Hansen, R G

1991-07-01

This article examines nutrition labeling history as well as the findings of nine research studies of nutrition labeling formats. Nutrition labeling regulations were announced in 1973 and have been periodically amended since then. In response to requests from consumers and health care professionals for revision of the labeling system, the Food and Drug Administration initiated a three-phase plan for reform of nutrition labeling in 1990. President Bush signed the Nutrition Labeling and Education Act in November 1990. Literature analysis revealed that only nine studies with an experimental design have focused on nutrition labeling since 1971. Four were conducted before 1975, which was the year that nutrition labeling was officially implemented, two were conducted in 1980, and three were conducted after 1986. Only two of the nine studies supported the traditional label format mandated by the Code of Federal Regulations, and one study partially supported it. Four of the nine studies that evaluated graphic presentations of nutrition information found that consumer comprehension of nutrition information was improved with a graphic format for nutrition labeling: three studies supported the use of bar graphs and one study supported the use of a pie chart. Full disclosure (ie, complete nutrient and ingredient labeling) was preferred by consumers in two of the three studies that examined this variable. The third study supported three types of information disclosure dependent upon socioeconomic class. In those studies that tested graphics, a bar graph format was significantly preferred and showed better consumer comprehension than the traditional format.

The Effect of a Novel form of Extended-Release Gabapentin on Pain and Sleep in Fibromyalgia Subjects: An Open-Label Pilot Study.

PubMed

North, James M; Hong, Kyung-Soo J; Rauck, Richard L

2016-07-01

We assessed the efficacy and safety of extended-release gabapentin in a 15-week, open-label, single-arm, single-center study in patients with fibromyalgia (FM). Subjects with documented diagnosis of FM were allowed to participate in the study. We opened enrollment to those who have tried and failed gabapentinoids such as gabapentin or pregabalin due to side effects. Subjects with autoimmune conditions, and or taking opioids for management of their FM pain, were excluded from the study. Subjects were given an extended-release gabapentin starter pack and treated for total of 12 weeks. The primary study endpoint of pain relief was measured using Numeric Pain Rating System (NPRS) scores, and secondary study endpoints were measured with Fibromyalgia Impact Questionnaire (FIQ), Patient's Global Impression of Change (PGIC), and Medical Outcome Sleep questionnaires (MOS). A total of 34 subjects were enrolled and 29 subjects completed the starter pack (85%). Patients reported significant pain relief on NPRS by end of 4 weeks (P < 0.0001) on NPRS. Subjects also reported similar magnitude of improvements in FM and its impact on daily life by end of 4 weeks on FIQ (P < 0.0001). Survey of MOS showed our subjects reporting improved sleep quantity (on average, 1.2 hours over baseline) with gradual and statistically significant improvement in quality. Improvements in primary and secondary measurements were reflected in PGIC, with significant improvement in patient's impression of FM by week 8. Small sample size, geographical bias, relatively short duration of treatment, and single-arm study without control group. Extended-release gabapentin relieved FM pain symptoms and improved quality-of-life for the FM subjects studied. Subjects reported improvements in both quantity and quality of sleep. © 2015 World Institute of Pain.

Mass Spectrometry Data Collection in Parallel at Multiple Core Facilities Operating TripleTOF 5600 and Orbitrap Elite/Velos Pro/Q Exactive Mass Spectrometers

PubMed Central

Jones, K.; Kim, K.; Patel, B.; Kelsen, S.; Braverman, A.; Swinton, D.; Gafken, P.; Jones, L.; Lane, W.; Neveu, J.; Leung, H.; Shaffer, S.; Leszyk, J.; Stanley, B.; Fox, T.; Stanley, A.; Yeung, Anthony

2013-01-01

Proteomic research can benefit from simultaneous access to multiple cutting-edge mass spectrometers. 18 core facilities responded to our investigators seeking service through the ABRF Discussion Forum. Five of the facilities selected completed four plasma proteomics experiments as routine fee-for-service. Each biological experiment entailed an iTRAQ 4-plex proteome comparison of immunodepleted plasma provided as 30 labeled-peptide fractions. Identical samples were analyzed by two AB SCIEX TripleTOF 5600 and three Thermo Orbitrap (Elite/Velos Pro/Q Exactive) instruments. 480 LC-MS/MS runs delivered >250 GB of data over two months. We compare herein routine service analyses of three peptide fractions of different peptide abundance. Data files from each instrument were studied to develop optimal analysis parameters to compare with default parameters in Mascot Distiller 2.4, ProteinPilot 4.5 beta, AB Sciex MS Data Converter 1.3 beta, and Proteome Discover 1.3. Peak-picking for TripleTOFs was best by ProteinPilot 4.5 beta while Mascot Distiller and Proteome Discoverer were comparable for the Orbitraps. We compared protein identification and quantitation in SwissProt 2012_07 database by Mascot Server 2.4.01 versus ProteinPilot. By all search methods, more proteins, up to two fold, were identified using the Q Exactive than others. Q Exactive excelled also at the number of unique significant peptide ion sequences. However, software-dependent impact on subsequent interpretation, due to peptide modifications, can be critical. These findings may have special implications for iTRAQ plasma proteomics. For the low abundance peptide ions, the slope of the dynamic range drop-off in the plasma proteome is uniquely sharp compared with cell lysates. Our study provides data for testable improvements in the operation of these mass spectrometers. More importantly, we have demonstrated a new affordable expedient workflow for investigators to perform proteomic experiments through the ABRF infrastructure. (We acknowledge John Cottrell for optimizing the peak-picking parameters for Mascot Distiller).

Open-label add-on treatment trial of minocycline in fragile X syndrome.

PubMed

Paribello, Carlo; Tao, Leeping; Folino, Anthony; Berry-Kravis, Elizabeth; Tranfaglia, Michael; Ethell, Iryna M; Ethell, Douglas W

2010-10-11

Fragile X syndrome (FXS) is a disorder characterized by a variety of disabilities, including cognitive deficits, attention-deficit/hyperactivity disorder, autism, and other socio-emotional problems. It is hypothesized that the absence of the fragile X mental retardation protein (FMRP) leads to higher levels of matrix metallo-proteinase-9 activity (MMP-9) in the brain. Minocycline inhibits MMP-9 activity, and alleviates behavioural and synapse abnormalities in fmr1 knockout mice, an established model for FXS. This open-label add-on pilot trial was conducted to evaluate safety and efficacy of minocycline in treating behavioural abnormalities that occur in humans with FXS. Twenty individuals with FXS, ages 13-32, were randomly assigned to receive 100 mg or 200 mg of minocycline daily. Behavioural evaluations were made prior to treatment (baseline) and again 8 weeks after daily minocycline treatment. The primary outcome measure was the Aberrant Behaviour Checklist-Community Edition (ABC-C) Irritability Subscale, and the secondary outcome measures were the other ABC-C subscales, clinical global improvement scale (CGI), and the visual analog scale for behaviour (VAS). Side effects were assessed using an adverse events checklist, a complete blood count (CBC), hepatic and renal function tests, and antinuclear antibody screen (ANA), done at baseline and at 8 weeks. The ABC-C Irritability Subscale scores showed significant improvement (p < 0.001), as did the VAS (p = 0.003) and the CGI (p < 0.001). The only significant treatment-related side effects were minor diarrhea (n = 3) and seroconversion to a positive ANA (n = 2). Results from this study demonstrate that minocycline provides significant functional benefits to FXS patients and that it is well-tolerated. These findings are consistent with the fmr1 knockout mouse model results, suggesting that minocycline modifies underlying neural defects that account for behavioural abnormalities. A placebo-controlled trial of minocycline in FXS is warranted. ClinicalTrials.gov Open-Label Trial NCT00858689.

Deep brain stimulation of the basolateral amygdala for treatment-refractory combat post-traumatic stress disorder (PTSD): study protocol for a pilot randomized controlled trial with blinded, staggered onset of stimulation.

PubMed

Koek, Ralph J; Langevin, Jean-Philippe; Krahl, Scott E; Kosoyan, Hovsep J; Schwartz, Holly N; Chen, James W Y; Melrose, Rebecca; Mandelkern, Mark J; Sultzer, David

2014-09-10

Combat post-traumatic stress disorder (PTSD) involves significant suffering, impairments in social and occupational functioning, substance use and medical comorbidity, and increased mortality from suicide and other causes. Many veterans continue to suffer despite current treatments. Deep brain stimulation (DBS) has shown promise in refractory movement disorders, depression and obsessive-compulsive disorder, with deep brain targets chosen by integration of clinical and neuroimaging literature. The basolateral amygdala (BLn) is an optimal target for high-frequency DBS in PTSD based on neurocircuitry findings from a variety of perspectives. DBS of the BLn was validated in a rat model of PTSD by our group, and limited data from humans support the potential safety and effectiveness of BLn DBS. We describe the protocol design for a first-ever Phase I pilot study of bilateral BLn high-frequency DBS for six severely ill, functionally impaired combat veterans with PTSD refractory to conventional treatments. After implantation, patients are monitored for a month with stimulators off. An electroencephalographic (EEG) telemetry session will test safety of stimulation before randomization to staggered-onset, double-blind sham versus active stimulation for two months. Thereafter, patients will undergo an open-label stimulation for a total of 24 months. Primary efficacy outcome is a 30% decrease in the Clinician Administered PTSD Scale (CAPS) total score. Safety outcomes include extensive assessments of psychiatric and neurologic symptoms, psychosocial function, amygdala-specific and general neuropsychological functions, and EEG changes. The protocol requires the veteran to have a cohabiting significant other who is willing to assist in monitoring safety and effect on social functioning. At baseline and after approximately one year of stimulation, trauma script-provoked 18FDG PET metabolic changes in limbic circuitry will also be evaluated. While the rationale for studying DBS for PTSD is ethically and scientifically justified, the importance of the amygdaloid complex and its connections for a myriad of emotional, perceptual, behavioral, and vegetative functions requires a complex trial design in terms of outcome measures. Knowledge generated from this pilot trial can be used to design future studies to determine the potential of DBS to benefit both veterans and nonveterans suffering from treatment-refractory PTSD. PCC121657, 19 March 2014.

SUPERFUND TREATABILITY CLEARINGHOUSE: PILOT STUDY OF ENCLOSED THERMAL SOIL AERATION FOR REMOVAL OF VOLATILE ORGANIC CONTAMINATION AT THE MCKIN SUPERFUND SITE

EPA Science Inventory

This paper reports on the results of a pilot study that treated vadose zone soil contaminated with VOCs in an enclosed thermal aeration system. The McKin site, an NPL site in Grey, Maine, was the location of the pilot study. The pilot study was chosen to demonstrate the viabili...

Impact of food labelling systems on food choices and eating behaviours: a systematic review and meta-analysis of randomized studies.

PubMed

Cecchini, M; Warin, L

2016-03-01

Food labels are considered a crucial component of strategies tackling unhealthy diets and obesity. This study aims at assessing the effectiveness of food labelling in increasing the selection of healthier products and in reducing calorie intake. In addition, this study compares the relative effectiveness of traffic light schemes, Guideline Daily Amount and other food labelling schemes. A comprehensive set of databases were searched to identify randomized studies. Studies reporting homogeneous outcomes were pooled together and analysed through meta-analyses. Publication bias was evaluated with a funnel plot. Food labelling would increase the amount of people selecting a healthier food product by about 17.95% (confidence interval: +11.24% to +24.66%). Food labelling would also decrease calorie intake/choice by about 3.59% (confidence interval: -8.90% to +1.72%), but results are not statistically significant. Traffic light schemes are marginally more effective in increasing the selection of healthier options. Other food labels and Guideline Daily Amount follow. The available evidence did not allow studying the effects of single labelling schemes on calorie intake/choice. Findings of this study suggest that nutrition labelling may be an effective approach to empowering consumers in choosing healthier products. Interpretive labels, as traffic light labels, may be more effective. © 2015 World Obesity.

Patent foramen ovale and asymptomatic brain lesions in military fighter pilots.

PubMed

Kang, Kyung Wook; Kim, Joon-Tae; Choi, Won-Ho; Park, Won-Ju; Shin, Young Ho; Choi, Kang-Ho

2014-10-01

Previous studies have reported higher incidence of white matter lesions (WMLs) in military pilots. The anti-gravity straining maneuver, which fighter military pilots perform numerously during a flight is identical to the valsalva maneuver. We sought to investigate the prevalence of right-to-left shunt (RLS) associated with WMLs in military pilots. A prospective study was performed involving military pilots who visited the Airomedical Center. The pilots underwent brain magnetic resonance imaging (MRI) scan and transcranial Doppler (TCD) with intravenous injection of agitated saline solution for the detection of RLS. Periventricular WMLs (PVWMLs) on MRI were graded using Fazeka's scale, and deep WMLs (DWMLs) were graded using Scheltens's scale. This study included 81 military pilots. RLS on TCD was observed less frequently in non-fighter pilots than in fighter pilots (35.5% vs. 64.5%, p=0.011). Fighter pilot was an independently associated factor with RLS on the TCD. DWMLs were independently associated with RLSs through a patent foramen ovale (PFO) (OR 3.507, 95% CI 1.223-10.055, p=0.02). The results suggest that DWMLs in military pilots may significantly be associated with RLS via PFO. Additional investigations are warranted. Copyright © 2014 Elsevier B.V. All rights reserved.

Impact of explained v. unexplained front-of-package nutrition labels on parent and child food choices: a randomized trial.

PubMed

Graham, Dan J; Lucas-Thompson, Rachel G; Mueller, Megan P; Jaeb, Melanie; Harnack, Lisa

2017-04-01

The present study investigated whether parent/child pairs would select more healthful foods when: (i) products were labelled with front-of-package (FOP) nutrition labels relative to packages without labels; (ii) products were labelled with colour-coded Multiple Traffic Light (MTL) FOP labels relative to monochromatic Facts up Front (FuF) FOP labels; and (iii) FOP labels were explained via in-aisle signage v. unexplained. Participants were randomly assigned to one of five conditions: (i) FuF labels with in-aisle signs explaining the labels; (ii) FuF labels, no signage; (iii) MTL labels with in-aisle signage; (iv) MTL labels, no signage; (v) control group, no labels/signage. Saturated fat, sodium, sugar and energy (calorie) content were compared across conditions. The study took place in a laboratory grocery aisle. Parent/child pairs (n 153) completed the study. Results did not support the hypothesis that MTL labels would lead to more healthful choices than FuF labels. The presence of FOP labels did little to improve the healthfulness of selected foods, with few exceptions (participants with v. without access to FOP labels selected lower-calorie cereals, participants with access to both FOP labels and in-aisle explanatory signage selected products with less saturated fat v. participants without explanatory signage). Neither MTL nor FuF FOP labels led to food choices with significantly lower saturated fat, sodium or sugar. In-aisle signs explaining the FOP labels were somewhat helpful to consumers in making more healthful dietary decisions. New FOP labelling programmes could benefit from campaigns to increase consumer awareness and understanding of the labels.

Expertise and responsibility effects on pilots' reactions to flight deck alerts in a simulator.

PubMed

Zheng, Yiyuan; Lu, Yanyu; Yang, Zheng; Fu, Shan

2014-11-01

Flight deck alerts provide system malfunction information designed to lead corresponding pilot reactions aimed at guaranteeing flight safety. This study examined the roles of expertise and flight responsibility and their relationship to pilots' reactions to flight deck alerts. There were 17 pilots composing 12 flight crews that were assigned into pairs according to flight hours and responsibilities. The experiment included 9 flight scenarios and was carried out in a CRJ-200 flight simulator. Pilot performance was recorded by a wide angle video camera, and four kinds of reactions to alerts were defined for analysis. Pilots tended to have immediate reactions to uninterrupted cautions, with a turning off rate as high as 75%. However, this rate decreased sharply when pilots encountered interrupted cautions and warnings; they also exhibited many wrong reactions to warnings. Pilots with more expertise had more reactions to uninterrupted cautions than those with less expertise, both as pilot flying and pilot monitoring. Meanwhile, the pilot monitoring, regardless of level of expertise, exhibited more reactions than the pilot flying. In addition, more experienced pilots were more likely to have wrong reactions to warnings while acting as the monitoring pilot. These results suggest that both expertise and flight responsibility influence pilots' reactions to alerts. Considering crew pairing strategy, when a pilot flying is a less experienced pilot, a more experience pilot is suggested to be the monitoring pilot. The results of this study have implications for understanding pilots' behaviors to flight deck alerts, calling for specialized training and design of approach alarms on the flight deck.

Human factors in aviation crashes involving older pilots.

PubMed

Li, Guohua; Baker, Susan P; Lamb, Margaret W; Grabowski, Jurek G; Rebok, George W

2002-02-01

Pilot errors are recognized as a contributing factor in as many as 80% of aviation crashes. Experimental studies using flight simulators indicate that due to decreased working memory capacity, older pilots are outperformed by their younger counterparts in communication tasks and flight summary scores. This study examines age-related differences in crash circumstances and pilot errors in a sample of pilots who flew commuter aircraft or air taxis and who were involved in airplane or helicopter crashes. A historical cohort of 3306 pilots who in 1987 flew commuter aircraft or air taxis and were 45-54 yr of age was constructed using the Federal Aviation Administration's airmen information system. Crash records of the study subjects for the years 1983-1997 were obtained from the National Transportation Safety Board (NTSB) by matching name and date of birth. NTSB's investigation reports were reviewed to identify pilot errors and other contributing factors. Comparisons of crash circumstances and human factors were made between pilots aged 40-49 yr and pilots aged 50-63 yr. A total of 165 crash records were studied, with 52% of these crashes involving pilots aged 50-63 yr. Crash circumstances, such as time and location of crash, type and phase of flight, and weather conditions, were similar between the two age groups. Pilot error was a contributing factor in 73% of the crashes involving younger pilots and in 69% of the crashes involving older pilots (p = 0.50). Age-related differences in the pattern of pilot errors were statistically insignificant. Overall, 23% of pilot errors were attributable to inattentiveness, 20% to flawed decisions, 18% to mishandled aircraft kinetics, and 18% to mishandled wind/runway conditions. Neither crash circumstances nor the prevalence and patterns of pilot errors appear to change significantly as age increases from the 40s to the 50s and early 60s.

Technical specifications for mechanical recycling of agricultural plastic waste

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

Briassoulis, D., E-mail: briassou@aua.gr; Hiskakis, M.; Babou, E.

Highlights: • Technical specifications for agricultural plastic wastes (APWs) recycling proposed. • Specifications are the base for best economical and environmental APW valorisation. • Analysis of APW reveals inherent characteristics and constraints of APW streams. • Thorough survey on mechanical recycling processes and industry as it applies to APW. • Specifications for APW recycling tested, adjusted and verified through pilot trials. - Abstract: Technical specifications appropriate for the recycling of agricultural plastic wastes (APWs), widely accepted by the recycling industry were developed. The specifications establish quality standards to be met by the agricultural plastics producers, users and the agricultural plasticmore » waste management chain. They constitute the base for the best economical and environmental valorisation of the APW. The analysis of the APW streams conducted across Europe in the framework of the European project “LabelAgriWaste” revealed the inherent characteristics of the APW streams and the inherent constraints (technical or economical) of the APW. The APW stream properties related to its recycling potential and measured during pilot trials are presented and a subsequent universally accepted simplified and expanded list of APW recycling technical specifications is proposed and justified. The list includes two sets of specifications, applied to two different quality categories of recyclable APW: one for pellet production process (“Quality I”) and another one for plastic profile production process (“Quality II”). Parameters that are taken into consideration in the specifications include the APW physical characteristics, contamination, composition and degradation. The proposed specifications are focused on polyethylene based APW that represents the vast majority of the APW stream. However, the specifications can be adjusted to cover also APW of different materials (e.g. PP or PVC) that are found in very small quantities in protected cultivations in Europe. The adoption of the proposed specifications could transform this waste stream into a labelled commodity traded freely in the market and will constitute the base for the best economical and environmental valorisation of the APW.« less

The relationship among expressions, labels, and descriptions of contempt.

PubMed

Matsumoto, David; Ekman, Paul

2004-10-01

This article reports 4 studies that demonstrate that the contempt expression is reliably associated with situations that elicit contempt and that the inability to label the contempt expression reflects a problem with its label or concept and not with the relationship between its expression and emotion. In Study I, the labeling of contempt in fixed-choice judgment tasks did not occur because of a process of elimination. In Studies 2 and 3, the contempt expression was associated with situations that elicit contempt, but participants did not label the situations in an open-ended response. In Study 3, participants also more reliably labeled the contempt expression with situations rather than with labels and did not generate contempt situations from labels. In Study 4, participants reported using, hearing, and reading about contempt the least among 7 emotions tested. (c) 2004 APA, all rights reserved

Infants' understanding of false labeling events: the referential roles of words and the speakers who use them.

PubMed

Koenig, Melissa A; Echols, Catharine H

2003-04-01

The four studies reported here examine whether 16-month-old infants' responses to true and false utterances interact with their knowledge of human agents. In Study 1, infants heard repeated instances either of true or false labeling of common objects; labels came from an active human speaker seated next to the infant. In Study 2, infants experienced the same stimuli and procedure; however, we replaced the human speaker of Study 1 with an audio speaker in the same location. In Study 3, labels came from a hidden audio speaker. In Study 4, a human speaker labeled the objects while facing away from them. In Study 1, infants looked significantly longer to the human agent when she falsely labeled than when she truthfully labeled the objects. Infants did not show a similar pattern of attention for the audio speaker of Study 2, the silent human of Study 3 or the facing-backward speaker of Study 4. In fact, infants who experienced truthful labeling looked significantly longer to the facing-backward labeler of Study 4 than to true labelers of the other three contexts. Additionally, infants were more likely to correct false labels when produced by the human labeler of Study 1 than in any of the other contexts. These findings suggest, first, that infants are developing a critical conception of other human speakers as truthful communicators, and second, that infants understand that human speakers may provide uniquely useful information when a word fails to match its referent. These findings are consistent with the view that infants can recognize differences in knowledge and that such differences can be based on differences in the availability of perceptual experience.

Children and adolescent acceptability of a new device system to administer human growth hormone--a pilot study.

PubMed

Kappelgaard, Anne-Marie; Mikkelsen, Søren; Bagger, Claus; Fuchs, Gitte Schøning

2012-01-01

Growth hormone (GH) is used to treat growth failure in children and metabolic impairments in adults with GH deficiency (GHD). Treatment requires daily subcutaneous injections that may affect treatment outcomes, and subsequently efficacy outcomes. To enhance potential adherence, improved GH delivery device systems are being developed. To compare patient acceptability and usability of Norditropin FlexPro/FlexPro PenMate with Norditropin NordiFlex/NordiFlex PenMate for GH administration in children/adolescents with GHD. A multinational, open-label, uncontrolled study. Patients (n = 50; 4-18 years) currently on GH therapy injected test medium into a foam pad. Ease-of-use and patient device preference were recorded by questionnaire. The majority (80%) of patients preferred FlexPro PenMate over NordiFlex PenMate with 96% and 84%, respectively, reporting that they found the FlexPro PenMate system user-friendly and that they were highly confident using it. The FlexPro system was well accepted by patients. This may facilitate greater adherence to treatment and improve patient outcomes.

Aversion to injection limits acceptability of extended-release naltrexone among homeless, alcohol-dependent patients.

PubMed

Friedmann, Peter D; Mello, Dawn; Lonergan, Sean; Bourgault, Claire; O'Toole, Thomas P

2013-01-01

Ending homelessness is a major priority of the Department of Veteran Affairs (VA), and alcohol use can be a barrier to stable housing. Clinical trials suggest that depot extended-release naltrexone (XR-NTX) is efficacious in reducing alcohol consumption among alcohol-dependent subjects. An open-label, randomized pilot study sought to examine the feasibility and effectiveness of XR-NTX versus oral naltrexone to improve alcohol consumption and housing stability among homeless, alcohol-dependent veterans at the Providence Veteran Affairs Medical Center. Of 215 potential candidates approached over a 16-month recruitment period, only 15 agreed to consider study entry and 7 were randomized. The primary reasons given for refusal were not wanting an injection; fear of needles; and not wanting to change drinking habits. Only 1 participant in the XR-NTX group returned after the first injection. Three participants in the oral naltrexone group attended all 7 visits and had good outcomes. Although XR-NTX has demonstrated efficacy in reducing heavy drinking, limited acceptance of the injection might reduce its effectiveness among homeless, alcohol-dependent patients.

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.

Unilateral ultra-brief pulse electroconvulsive therapy for depression in Parkinson's disease.

PubMed

Williams, N R; Bentzley, B S; Sahlem, G L; Pannu, J; Korte, J E; Revuelta, G; Short, E B; George, M S

2017-04-01

Electroconvulsive therapy (ECT) has demonstrated efficacy in treating core symptoms of Parkinson's disease (PD); however, widespread use of ECT in PD has been limited due to concern over cognitive burden. We investigated the use of a newer ECT technology known to have fewer cognitive side effects (right unilateral [RUL] ultra-brief pulse [UBP]) for the treatment of medically refractory psychiatric dysfunction in PD. This open-label pilot study included 6 patients who were assessed in the motoric, cognitive, and neuropsychiatric domains prior to and after RUL UBP ECT. Primary endpoints were changes in total score on the HAM-D-17 and GDS-30 rating scales. Patients were found to improve in motoric and psychiatric domains following RUL UBP ECT without cognitive side effects, both immediately following ECT and at 1-month follow-up. This study demonstrates that RUL UBP ECT is safe, feasible, and potentially efficacious in treating multiple domains of PD, including motor and mood, without clear cognitive side effects. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Canine cancer screening via ultraviolet absorbance and fluorescence spectroscopy of serum proteins

NASA Astrophysics Data System (ADS)

Dickerson, Bryan D.; Geist, Brian L.; Spillman, William B., Jr.; Robertson, John L.

2007-11-01

A cost-effective optical cancer screening and monitoring technique was demonstrated in a pilot study of canine serum samples and was patented for commercialization. Compared to conventional blood chemistry analysis methods, more accurate estimations of the concentrations of albumin, globulins, and hemoglobin in serum were obtained by fitting the near UV absorbance and photoluminescence spectra of diluted serum as a linear combination of component reference spectra. Tracking these serum proteins over the course of treatment helped to monitor patient immune response to carcinoma and therapy. For cancer screening, 70% of dogs with clinical presentation of cancer displayed suppressed serum hemoglobin levels (below 20 mg/dL) in combination with atypical serum protein compositions, that is, albumin levels outside of a safe range (from 4 to 8 g/dL) and globulin levels above or below a more normal range (from 1.7 to 3.7 g/dL). Of the dogs that met these criteria, only 20% were given a false positive label by this cancer screening test.

Protocol for monitoring metals in Ozark National Scenic Riverways, Missouri: Version 1.0

USGS Publications Warehouse

Schmitt, Christopher J.; Brumbaugh, William G.; Besser, John M.; Hinck, Jo Ellen; Bowles, David E.; Morrison, Lloyd W.; Williams, Michael H.

2008-01-01

The National Park Service is developing a monitoring plan for the Ozark National Scenic Riverways in southeastern Missouri. Because of concerns about the release of lead, zinc, and other metals from lead-zinc mining to streams, the monitoring plan will include mining-related metals. After considering a variety of alternatives, the plan will consist of measuring the concentrations of cadmium, cobalt, lead, nickel, and zinc in composite samples of crayfish (Orconectes luteus or alternate species) and Asian clam (Corbicula fluminea) collected periodically from selected sites. This document, which comprises a protocol narrative and supporting standard operating procedures, describes the methods to be employed prior to, during, and after collection of the organisms, along with procedures for their chemical analysis and quality assurance; statistical analysis, interpretation, and reporting of the data; and for modifying the protocol narrative and supporting standard operating procedures. A list of supplies and equipment, data forms, and sample labels are also included. An example based on data from a pilot study is presented.

Interactive iPhone/iPad App for Increased Tympanic Membrane Familiarity.

PubMed

Samra, Sheena; Wu, Andrew; Redleaf, Miriam

2016-12-01

Otology relies on clinical examination to teach anatomy of the ear. The purpose of this report is to introduce the Buckingham Virtual Tympanum iPhone app as an adjuvant educational tool to teach the anatomical details of the tympanic membrane (TM). This app, available free at the Apple Store, was constructed using archival photographs of normal and abnormal TMs, stratified by difficulty. Each image has 4 labeled structures, linked to questions to encourage active learning. Third-year medical students then used the app to familiarize themselves with the TM. The free app was readily accessible and functioned without technical issues. By being interactive, it forced the user into the role of active learner. This pilot study found that students who used the app understood images of the TM better than those who did not use it. We introduce an interactive, iPhone-based smartphone application that we found to be a useful adjunct for teaching TM anatomy. © The Author(s) 2016.

Rotigotine may control drooling in patients with Parkinson's Disease: Preliminary findings.

PubMed

Schirinzi, Tommaso; Imbriani, Paola; D'Elia, Alessio; Di Lazzaro, Giulia; Mercuri, Nicola Biagio; Pisani, Antonio

2017-05-01

To evaluate the efficacy of rotigotine in controlling the drooling of Parkinson's Disease (PD) patients. We assessed 7 PD patients (Hoehn and Yahr scale >2.5) with three different clinical scores (Drooling Severity and Frequency Scale - DSFS, Drooling Rating Scale - DRS and Sialorrhea Clinical Scale for PD - SCS) before and after 4 weeks of therapy. Statistical differences were analyzed with Wilcoxon signed-rank test. We observed that rotigotine significantly improves drooling as measured by the lowering of the three scores (p<0.05). Among non-motor symptoms of PD, drooling is one of the most embarrassing and disabling for patients. Current treatments are unsatisfactory and novel approaches are thus desirable. In this open-label pilot study we demonstrated on a small sample of patients that up to 4mg/24h of rotigotine, a non-ergolinic dopamine agonist with continuous transdermal delivery, may be helpful in the management of drooling in advanced PD. Copyright © 2017 Elsevier B.V. All rights reserved.

The psychophysiological assessment method for pilot's professional reliability.

PubMed

Zhang, L M; Yu, L S; Wang, K N; Jing, B S; Fang, C

1997-05-01

Previous research has shown that a pilot's professional reliability depends on two relative factors: the pilot's functional state and the demands of task workload. The Psychophysiological Reserve Capacity (PRC) is defined as a pilot's ability to accomplish additive tasks without reducing the performance of the primary task (flight task). We hypothesized that the PRC was a mirror of the pilot's functional state. The purpose of this study was to probe the psychophysiological method for evaluating a pilot's professional reliability on a simulator. The PRC Comprehensive Evaluating System (PRCCES) which was used in the experiment included four subsystems: a) quantitative evaluation system for pilot's performance on simulator; b) secondary task display and quantitative estimating system; c) multiphysiological data monitoring and statistical system; and d) comprehensive evaluation system for pilot PRC. Two studies were performed. In study one, 63 healthy and 13 hospitalized pilots participated. Each pilot performed a double 180 degrees circuit flight program with and without secondary task (three digit operation). The operator performance, score of secondary task and cost of physiological effort were measured and compared by PRCCES in the two conditions. Then, each pilot's flight skill in training was subjectively scored by instructor pilot ratings. In study two, 7 healthy pilots volunteered to take part in the experiment on the effects of sleep deprivation on pilot's PRC. Each participant had PRC tested pre- and post-8 h sleep deprivation. The results show that the PRC values of a healthy pilot was positively correlated with abilities of flexibility, operating and correcting deviation, attention distribution, and accuracy of instrument flight in the air (r = 0.27-0.40, p < 0.05), and negatively correlated with emotional anxiety in flight (r = -0.40, p < 0.05). The values of PRC in healthy pilots (0.61 +/- 0.17) were significantly higher than that of hospitalized pilots (0.43 +/- 0.15) (p < 0.05). The PRC value after 8 h sleep loss (0.50 +/- 0.17) was significantly lower than those before sleep loss (0.70 +/- 0.15) (p < 0.05). We conclude that a pilot's PRC, which was closely related to flight ability and functional state, could partly represent the pilot's professional reliability. It is worthwhile to further research using a pilot's PRC as a predictor of mental workload in aircraft design.

Arab-American adolescent tobacco use: four pilot studies.

PubMed

Rice, Virginia Hill; Templin, Thomas; Kulwicki, Anahid

2003-11-01

Four pilot studies were conducted to determine the (1) current tobacco use patterns and predictors among 14- to 18-year-old Arab-American youths; (2) psychometric properties of study measures (English and Arabic); (3) cultural appropriateness of Project Toward No Tobacco (TNT) for intervention; (4) accessible population for a longitudinal study. Three studies were descriptive and one used a pretest-posttest design. From four Pilot Focus groups (N = 28 smokers) key tobacco use themes emerged along with information on study measures and the Project TNT intervention; Pilot Intervention tested the tailored Project TNT intervention with 9 Arab-American teens; Pilot Clinic (N = 44) determined the characteristics of the accessible teen health clinic population; and Pilot School (N = 119) obtained tobacco use data only. From Pilot Focus seven themes (being cool, "nshar ma'a al shabab" [hanging out with the guys], present [time] orientation, smoking feels and tastes good, keeps your mind off trouble, easy to get, and (many) "barriers to quitting") emerged from the data. In the Pilot Intervention a 37.5% cessation rate was found. In the Pilot Clinic study, 24% males and 17% females smoked. The current smoking rate in the Pilot School (N = 119) sample was 17%; 34% admitted to having ever smoked (even a puff). Significant predictors for current tobacco use included poor grades, stress, having many family members and peers who smoke, being exposed to many hours of smoking each day, receiving offers of tobacco products, advertising and mail, and believing that tobacco can help one to make friends. The four pilots contributed unique and essential knowledge for designing a longitudinal clinical trial on tobacco use by Arab-American adolescents.

Superficial dermabrasion versus topical tretinoin on early striae distensae: a randomized, pilot study.

PubMed

Hexsel, Doris; Soirefmann, Mariana; Porto, Manoela D; Schilling-Souza, Juliana; Siega, Carolina; Dal'Forno, Taciana

2014-05-01

Striae distensae (SD) is a common skin condition, with a prevalence ranging from 40% to 90%, depending on the population studied. To evaluate the efficacy of superficial dermabrasion and compare it with that of topical tretinoin cream in the treatment of narrow and early SD. Prospective, single-center, randomized, open-label study. Thirty-two women presenting with early, untreated SD (striae rubra) were included in this study. One group received 16 weekly sessions of superficial and localized dermabrasion, and the other used 0.05% tretinoin cream daily. Striae width and length were measured and compared between groups and over time. Global Aesthetic Improvement Scale scores and subject satisfaction were also assessed. Biopsies were performed for subjects who agreed to undergo this procedure, followed by histologic analyses of the skin samples. Both treatments were efficacious, with significant improvement in early SD from baseline, but there was no significant difference between the two treatments. Histologic assessment showed improvement in epidermal and dermal layers for the dermabrasion treatment group. Both treatments had similar efficacy, but superficial dermabrasion had a lower frequency of side effects and better adherence of the patients. © 2014 by the American Society for Dermatologic Surgery, Inc. Published by Wiley Periodicals, Inc.

Fenticonazole nitrate for treatment of vulvovaginitis: efficacy, safety, and tolerability of 1-gram ovules, administered as ultra-short 2-day regimen.

PubMed

Fernández-Alba, J; Valle-Gay, A; Dibildox, M; Vargas, J A; González, J; García, M; López, L H

2004-04-01

Because of its potential as a low cost first-line monotherapy for the most common vulvovaginal infections, we evaluated fenticonazole nitrate in a prospective, open-label, multicenter pilot study with 101 sexually active women (per-protocol; 16 to 61 years of age) with vulvovaginitis involving single or mixed infections with Candida albicans, Trichomonas vaginalis, and/or Gardnerella vaginalis. Fenticonazole nitrate (1 g) was administered as vaginal ovules, once daily on days 1 and 3. Eradication (direct phase-contrast microscopy of vaginal swabs and/or microbiological culture) on day 8 was 90% (C. albicans, 26/29, p < 0.001), 70% (T. vaginalis, 7/10, p = 0.161), 67% (G. vaginalis, 22/33, p < 0.009), and 45% (mixed infection, 13/29, p = 0.001). After 28 days, relapse was 0% for candidiasis and trichomoniasis, 27% (6/22) for G. vaginalis, and 23% (3/13) for mixed infection. Overall, eradication of all offending pathogens was achieved in 67% of the total per-protocol population, with a relapse rate of only 16%. Score sums for symptoms improved from 7.0 (baseline) to 1.7 (day 8), and 0.71 (day 28), (p < 0.001). Treatment was safe and well tolerated. The results of our pilot study suggest that application of fenticonazole nitrate 1 g intravaginal ovules on 2 alternate days is a suitable first-line treatment of vulvovaginitis with acceptable broad-spectrum efficacy against the most commonly involved pathogens and with a low rate of early relapse, reserving antibiotics for patients with treatment failure or relapse of infection. Our results should encourage further examination of this approach in larger and well controlled clinical trials.

Design and baseline characteristics of participants in the Enhancing Physical Activity and Reducing Obesity through Smartcare and Financial Incentives (EPAROSFI): A pilot randomized controlled trial.

PubMed

Shin, Dong Wook; Joh, Hee-Kyung; Yun, Jae Moon; Kwon, Hyuk Tae; Lee, Hyejin; Min, Hyeyeon; Shin, Jung-Hyun; Chung, Won Joo; Park, Jin Ho; Cho, BeLong

2016-03-01

An activity tracker combined with a smartphone application (smartcare) may help people track and receive feedback on their own activities. However, activity trackers themselves generally fail to drive long-term sustained engagement for a majority of users. One potential strategy for increasing the effectiveness of smartcare is through the use of incentives. The purpose of this pilot randomized trial is to test the feasibility of our intervention and to assess the extent to which smartcare with or without financial incentives can increase physical activity levels and reduce weight over a 12-week period. This study employs a three-arm, open-label randomized controlled trial design: control (standard basic education), smartcare, and smartcare plus financial incentives. Male university students with body mass index ≥ 27 are enrolled. Our primary and secondary endpoints are the amount of weight loss and the level of physical activity respectively. The weight loss goal is 3% of baseline at week 4, 5% at week 8, and 7% at week 12. The daily physical activity goal was individualized according to the participants' weight. Process incentives are accumulated when participants met daily physical activity goals, and outcome incentives are provided when they met weight reduction goals. Given the global increase in physical inactivity and obesity, there is a growing need for effective, scalable, and affordable health promotion strategies. Our proof-of-concept study will provide the evidence for the combination of rising health promotion technology of activity trackers and smartphone applications with the modern concept of behavioral economics using financial incentives. Copyright © 2015. Published by Elsevier Inc.

Comparative Assessment of Lixisenatide, Exenatide, and Liraglutide Pen Devices: A Pilot User-Based Study.

PubMed

Stauder, Udo; Enginee, Diplom; Elton, Hina; Penfornis, Alfred; Edelman, Steve

2014-01-01

Glucagon-like peptide-1 (GLP-1) receptor agonists are a relatively recent addition to the treatment options for type 2 diabetes mellitus (T2DM) and are administered using prefilled pen devices. In this open-label task and interview-based pilot study, 3 GLP-1 receptor agonist pen devices-exenatide (Byetta ® , Bristol-Myers Squibb/AstraZeneca), liraglutide (Victoza ® , Novo Nordisk), and lixisenatide (Lyxumia ® , Sanofi-Aventis)-were comparatively assessed in a randomized order in 30 participants with T2DM for ease of use, using a series of key performance measures (time taken to complete a series of tasks, number of user errors [successful performance], and user satisfaction rating). Linear and logistic regression analysis was conducted for the lixisenatide and liraglutide pens versus the exenatide pen. Participants' mean age was 60 years; 27% and 20% of the participants had visual impairments and reduced manual dexterity, respectively. Tasks were completed faster (P < .001) and with higher successful performance (P = .001) with the lixisenatide pen than with the exenatide pen, whereas the liraglutide pen was not statistically significant versus the exenatide pen on these parameters. Overall, user satisfaction was statistically higher for the lixisenatide and liraglutide pens versus the exenatide pen (P < .001 for both). Lixisenatide and liraglutide pens are associated with higher user satisfaction compared with the exenatide pen. In addition, the lixisenatide pen is faster and results in fewer errors than its comparator (exenatide). The lixisenatide pen may therefore be a suitable choice for patients with T2DM, including older and pen device-naïve patients, and those with visual impairments and reduced manual dexterity. © 2014 Diabetes Technology Society.

Changes in the immune response after treatment with benznidazole versus no treatment in patients with chronic indeterminate Chagas disease.

PubMed

Vallejo, Alejandro; Monge-Maillo, Begoña; Gutiérrez, Carolina; Norman, Francesca F; López-Vélez, Rogelio; Pérez-Molina, José A

2016-12-01

Symptomatic chronic Chagas disease affects up to 40% of patients infected with Trypanosoma cruzi. The lack of reliable early markers of cure after therapy hinders disease management and clinical trials with new drugs. We performed a study with 18 months of follow-up to compare changes in immune parameters and T. cruzi-specific immune responses as surrogate markers of response to therapy between patients treated with benznidazole and untreated patients. This was a pilot, open-label, randomised clinical trial of treatment with benznidazole versus no treatment in patients with indeterminate chronic T. cruzi infection. In both groups we investigated changes in T-cell activation, T-cell subpopulations, regulatory T-cell counts, IL6, and sCD14 levels, and T. cruzi-specific immune responses (Th1, Th2, and Th17 responses). Fourteen patients were included in the study (seven in each group). Median age was 35 years (P 25-75 31-43), 57% were female, and 93% were Bolivian. Benznidazole was administered at 5mg/kg/day for 60days. Three patients discontinued benznidazole owing to adverse reactions and were not evaluated. At the end of the follow-up period, treated patients showed significantly less immune activation and lower regulatory T-cell counts, with an increased Th17 and Th1 response. This randomised pilot clinical trial administering benznidazole to patients with indeterminate chronic Chagas disease brings about changes in the adaptive immunity, leading to a general decrease in inflammatory status. This apparently beneficial response could act as the basis for monitoring new antiparasitic drugs. Copyright © 2016 Elsevier B.V. All rights reserved.

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

Efficacy and Safety of the Traditional Herbal Medicine, Gamiguibi-tang, in Patients With Cancer-Related Sleep Disturbance: A Prospective, Randomized, Wait-List-Controlled, Pilot Study.

PubMed

Lee, Jee Young; Oh, Hye Kyung; Ryu, Han Sung; Yoon, Sung Soo; Eo, Wankyu; Yoon, Seong Woo

2018-06-01

Sleep disturbance is the second most bothersome symptom in patients with cancer, and it can significantly impair their quality of life. The aim of this study was to investigate the efficacy and safety of the traditional herbal medicine Gamiguibi-tang (GGBT) in patients with cancer-related sleep disturbance. We conducted a prospective, randomized, wait-list-controlled, open-label pilot clinical trial on cancer-related sleep disturbance. Patients with cancer experiencing poor sleep quality with a Pittsburgh Sleep Quality Index of at least 6 were randomly assigned to the GGBT and wait-list groups to receive GGBT and conventional care, respectively, for 2 weeks. The primary endpoint was the Insomnia Severity Index (ISI) score. Fatigue, depression, and cognitive impairment were assessed as the secondary endpoints by using the Brief Fatigue Inventory (BFI), Beck Depression Inventory (BDI), and Montreal Cognitive Assessment (MoCA). Thirty participants who met the eligibility criteria were enrolled. Sleep disturbance assessed using the ISI improved significantly more in the GGBT group than in the wait-list group (-5.5 ± 4.4 vs 0.1 ± 1.1, P < .001). Fatigue level determined using the BFI also improved significantly more in the GGBT group than in the wait-list group (-0.8 ± 0.8 vs 0.0 ± 0.3, P = .002). The BDI and MoCA scores showed no significant changes. Adverse events were reported in two patients in the GGBT group and consisted of mild dyspepsia and mild edema. GGBT may be a potential treatment option for cancer-related sleep disturbance. Further research is needed to investigate the efficacy and safety of GGBT.

Rational drug use in Cambodia: study of three pilot health centers in Kampong Thom Province.

PubMed

Chareonkul, Chanin; Khun, Va Luong; Boonshuyar, Chaweewon

2002-06-01

This study obtained baseline information for the design of a strategy to address irrational prescribing practices in three health centers in Kampong Thom Province, Cambodia. Indicators of rational drug use have been measured and compared with Standard Guidelines. Data were collected from patients' registers and by interviewing patients immediately after patient-prescriber and patient-dispenser encounters. Checklists and pre-designed forms were used to collect data regarding the World Health Organization drug use indicators and some additional indices. Of the 330 prescriptions analyzed, the results showed that the average number of drugs per prescription was 2.35 and that a large proportion of the prescriptions contained two or more drugs that could result in adverse drug interactions. Prescribing by generic names (99.8%) was encouraging. The exposure of patients to antibiotics (66% to 100%) was high, and injection use (2.4%) was often unnecessary. Prescribing from the Essential Drugs List (99.7%) was satisfactory. The average consultation and dispensing times were short and not sufficient for patients to get health information. All the prescribed drugs were supplied, but all were inadequately labeled. Some 55% of patients knew the correct dosage of their drugs. The availability of key essential drugs (86.6%) was below the Standard. The percentages of appropriate prescriptions for treating malaria, diarrhea and acute respiratory infection treatment were 68.3%, 3.3%, and 45%, respectively. Inappropriate prescriptions were mostly due to unsuitable dosages, incorrect drugs, and the improper duration of treatment. The results suggest a need for intervention to curb the irrational use of drugs in prescribing at the three pilot health centers. Continuing education of prescribers and healthcare providers, monitoring, supervision, public education would be beneficial.

78 FR 23941 - Pilot Program for Early Feasibility Study Investigational Device Exemption Applications...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-23

...] Pilot Program for Early Feasibility Study Investigational Device Exemption Applications; Extending the... 13343), FDA terminated the acceptance of applications into the program and extended the pilot program for the nine accepted sponsors until May 8, 2013. The pilot program will be further extended for the...

Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework.

PubMed

Eldridge, Sandra M; Lancaster, Gillian A; Campbell, Michael J; Thabane, Lehana; Hopewell, Sally; Coleman, Claire L; Bond, Christine M

2016-01-01

We describe a framework for defining pilot and feasibility studies focusing on studies conducted in preparation for a randomised controlled trial. To develop the framework, we undertook a Delphi survey; ran an open meeting at a trial methodology conference; conducted a review of definitions outside the health research context; consulted experts at an international consensus meeting; and reviewed 27 empirical pilot or feasibility studies. We initially adopted mutually exclusive definitions of pilot and feasibility studies. However, some Delphi survey respondents and the majority of open meeting attendees disagreed with the idea of mutually exclusive definitions. Their viewpoint was supported by definitions outside the health research context, the use of the terms 'pilot' and 'feasibility' in the literature, and participants at the international consensus meeting. In our framework, pilot studies are a subset of feasibility studies, rather than the two being mutually exclusive. A feasibility study asks whether something can be done, should we proceed with it, and if so, how. A pilot study asks the same questions but also has a specific design feature: in a pilot study a future study, or part of a future study, is conducted on a smaller scale. We suggest that to facilitate their identification, these studies should be clearly identified using the terms 'feasibility' or 'pilot' as appropriate. This should include feasibility studies that are largely qualitative; we found these difficult to identify in electronic searches because researchers rarely used the term 'feasibility' in the title or abstract of such studies. Investigators should also report appropriate objectives and methods related to feasibility; and give clear confirmation that their study is in preparation for a future randomised controlled trial designed to assess the effect of an intervention.

Comparison of nicotine oral soluble film and nicotine lozenge on efficacy in relief of smoking cue-provoked acute craving after a single dose of treatment in low dependence smokers.

PubMed

Du, Daniel; Nides, Mitchell; Borders, James; Selmani, Alex; Waverczak, William

2014-11-01

Pilot study results suggested that a new form of nicotine oral soluble film relieved smoking cue-provoked acute craving faster than nicotine lozenge or gum. The new nicotine film may provide smokers another choice to relieve acute craving. This study compared the efficacy of the 2.5 mg nicotine oral soluble film to 2 mg nicotine lozenge for acute relief of smoking cue-provoked craving. A randomized, open label, active comparator controlled, parallel group study was conducted with 322 smokers enrolled. After 4 h of abstinence from smoking, eligible subjects were exposed to smoking cues as provocation. Immediately after the post-provocation baseline craving assessment using a 0-100 mm visual analogue scale (VAS), subjects took a randomized single dose of either the 2.5 mg nicotine film or the 2 mg nicotine lozenge. Craving assessments were completed at 50 s, 3 min, 5 min, 7 min, 15 min, 20 min, 25 min and 30 min after drug administration. Both treatments reduced cue-induced craving and had similar maximum effects on craving relief. However, the 2.5 mg nicotine film relieved cue-induced craving to a greater degree than the 2 mg nicotine lozenge at 50 s (mean difference: -4.9, p = 0.014), 3 min (mean difference: -6.7, p = 0.011), and 5 min (mean difference: -5.6, p = 0.049) post-treatment. The study confirmed the results from the pilot study. The 2.5 mg nicotine film relieved cue-provoked craving much quicker than the 2 mg nicotine lozenge while both having similar maximum effects. Nicotine film could be useful to provide quick craving relief for low dependence smokers.

Less label, more free: approaches in label-free quantitative mass spectrometry.

PubMed

Neilson, Karlie A; Ali, Naveid A; Muralidharan, Sridevi; Mirzaei, Mehdi; Mariani, Michael; Assadourian, Gariné; Lee, Albert; van Sluyter, Steven C; Haynes, Paul A

2011-02-01

In this review we examine techniques, software, and statistical analyses used in label-free quantitative proteomics studies for area under the curve and spectral counting approaches. Recent advances in the field are discussed in an order that reflects a logical workflow design. Examples of studies that follow this design are presented to highlight the requirement for statistical assessment and further experiments to validate results from label-free quantitation. Limitations of label-free approaches are considered, label-free approaches are compared with labelling techniques, and forward-looking applications for label-free quantitative data are presented. We conclude that label-free quantitative proteomics is a reliable, versatile, and cost-effective alternative to labelled quantitation. Copyright © 2011 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

KEY COMPARISON: CCQM-K25: Determination of PCB congeners in sediment

NASA Astrophysics Data System (ADS)

Schantz, Michele; Wise, Stephen

2004-01-01

Polychlorinated biphenyls (PCBs) consist of 209 possible congeners depending on the substitution of the chlorine atoms around the biphenyl molecule. PCBs have been widely used as industrial fluids, flame retardants, diluents, hydraulic fluids, and dielectric fluids for capacitors and transformers. As a class of compounds, they are environmentally stable and tend to bioaccumulate. Of the 209 possible congeners, approximately 150 congeners have been reported in the environment. Congener-specific PCB methods, which are typically based on gas chromatography (GC) with electron capture detection (ECD) or mass spectrometric (MS) detection, are designed to measure selected priority congeners, but the congeners of interest change with the study and sponsoring agency. A pilot study (CCQM-P17) for the determination of PCB congeners in sediment was organized by NIST and NRC-Canada in 2000. Ten laboratories participated in the pilot study. After discussion and critical review of the data, there was agreement that the pilot study should be followed by a Key Comparison and that the Key Comparison Reference Value (KCRV) should be derived from isotope dilution GC/MS (ID-GC/MS) based methods that had been validated in the Pilot Study. The CCQM-K25 Key Comparison study utilized a sediment sample prepared by mixing known quantities of two sediment materials to simulate a moderately contaminated sample with respect to PCBs. Nine laboratories participated in CCQM-K25 and demonstrated a high level of equivalence in capabilities for determining five PCB congeners (congener numbers 28, 101, 105, 153, and 170) in a moderately contaminated sediment using GC/MS-based methods. The amount of substance concentration for the congeners measured ranged from ~10 ng/g to ~35 ng/g. The relative expanded uncertainties of the KCRVs ranged from 2% to 5%, indicating excellent agreement among the participants that used ID-GC/MS. Results from the one laboratory that used GC/MS with a non-labeled PCB congener as internal standard showed no systematic bias from the results of other laboratories. The five PCB congeners measured in CCQM-K25 were selected to be representative of the approximately 150 congeners found in environmental samples and to provide the typical analytical measurement challenges encountered in the measurement of individual congeners such as volatility losses during sample preparation and coelution during chromatographic separation. The abilities demonstrated by the laboratories that provided comparable measurements for all five congeners in this Key Comparison should be indicative of their ability to provide reference measurements for the typical suite of PCB congeners found in moderately contaminated sediments (individual congener amount of substance concentrations >5 ng/g dry basis). Main text. To reach the main text of this paper, click on Final Report. Note that this text is that which appears in Appendix B of the BIPM key comparison database kcdb.bipm.org/. The final report has been peer-reviewed and approved for publication by the CCQM, according to the provisions of the Mutual Recognition Arrangement (MRA).

Comparison of Doxycycline, Minocycline, Doxycycline plus Albendazole and Albendazole Alone in Their Efficacy against Onchocerciasis in a Randomized, Open-Label, Pilot Trial

PubMed Central

Batsa, Linda; Ayisi-Boateng, Nana Kwame; Osei-Mensah, Jubin; Mubarik, Yusif; Konadu, Peter; Ricchiuto, Arcangelo; Fimmers, Rolf; Arriens, Sandra; Dubben, Bettina; Ford, Louise; Taylor, Mark; Hoerauf, Achim

2017-01-01

The search for new macrofilaricidal drugs against onchocerciasis that can be administered in shorter regimens than required for doxycycline (DOX, 200mg/d given for 4–6 weeks), identified minocycline (MIN) with superior efficacy to DOX. Further reduction in the treatment regimen may be achieved with co-administration with standard anti-filarial drugs. Therefore a randomized, open-label, pilot trial was carried out in an area in Ghana endemic for onchocerciasis, comprising 5 different regimens: the standard regimen DOX 200mg/d for 4 weeks (DOX 4w, N = 33), the experimental regimens MIN 200mg/d for 3 weeks (MIN 3w; N = 30), DOX 200mg/d for 3 weeks plus albendazole (ALB) 800mg/d for 3 days (DOX 3w + ALB 3d, N = 32), DOX 200mg/d for 3 weeks (DOX 3w, N = 31) and ALB 800mg for 3 days (ALB 3d, N = 30). Out of 158 randomized participants, 116 (74.4%) were present for the follow-up at 6 months of whom 99 participants (63.5%) followed the treatment per protocol and underwent surgery. Histological analysis of the adult worms in the extirpated nodules revealed absence of Wolbachia in 98.8% (DOX 4w), 81.4% (DOX 3w + ALB 3d), 72.7% (MIN 3w), 64.1% (DOX 3w) and 35.2% (ALB 3d) of the female worms. All 4 treatment regimens showed superiority to ALB 3d (p < 0.001, p < 0.001, p = 0.002, p = 0.008, respectively), which was confirmed by real-time PCR. Additionally, DOX 4w showed superiority to all other treatment arms. Furthermore DOX 4w and DOX 3w + ALB 3d showed a higher amount of female worms with degenerated embryogenesis compared to ALB 3d (p = 0.028, p = 0.042, respectively). These results confirm earlier studies that DOX 4w is sufficient for Wolbachia depletion and the desired parasitological effects. The data further suggest that there is an additive effect of ALB (3 days) on top of that of DOX alone, and that MIN shows a trend for stronger potency than DOX. These latter two results are preliminary and need confirmation in a fully randomized controlled phase 2 trial. Trial Registration: ClinicalTrials.gov #06010453 PMID:28056021

Effects of a structured 20-session slow-cortical-potential-based neurofeedback program on attentional performance in children and adolescents with attention-deficit hyperactivity disorder: retrospective analysis of an open-label pilot-approach and 6-month follow-up.

PubMed

Albrecht, Johanna S; Bubenzer-Busch, Sarah; Gallien, Anne; Knospe, Eva Lotte; Gaber, Tilman J; Zepf, Florian D

2017-01-01

The aim of this approach was to conduct a structured electroencephalography-based neurofeedback training program for children and adolescents with attention-deficit hyperactivity disorder (ADHD) using slow cortical potentials with an intensive first (almost daily sessions) and second phase of training (two sessions per week) and to assess aspects of attentional performance. A total of 24 young patients with ADHD participated in the 20-session training program. During phase I of training (2 weeks, 10 sessions), participants were trained on weekdays. During phase II, neurofeedback training occurred twice per week (5 weeks). The patients' inattention problems were measured at three assessment time points before (pre, T0) and after (post, T1) the training and at a 6-month follow-up (T2); the assessments included neuropsychological tests (Alertness and Divided Attention subtests of the Test for Attentional Performance; Sustained Attention Dots and Shifting Attentional Set subtests of the Amsterdam Neuropsychological Test) and questionnaire data (inattention subscales of the so-called Fremdbeurteilungsbogen für Hyperkinetische Störungen and Child Behavior Checklist/4-18 [CBCL/4-18]). All data were analyzed retrospectively. The mean auditive reaction time in a Divided Attention task decreased significantly from T0 to T1 (medium effect), which was persistent over time and also found for a T0-T2 comparison (larger effects). In the Sustained Attention Dots task, the mean reaction time was reduced from T0-T1 and T1-T2 (small effects), whereas in the Shifting Attentional Set task, patients were able to increase the number of trials from T1-T2 and significantly diminished the number of errors (T1-T2 & T0-T2, large effects). First positive but very small effects and preliminary results regarding different parameters of attentional performance were detected in young individuals with ADHD. The limitations of the obtained preliminary data are the rather small sample size, the lack of a control group/a placebo condition and the open-label approach because of the clinical setting and retrospective analysis. The value of the current approach lies in providing pilot data for future studies involving larger samples.

Study to determine the IFR operational profile and problems of the general aviation single pilot

NASA Technical Reports Server (NTRS)

Weislogel, G. S.

1983-01-01

General aviation single pilot operating under instrument flight rules (GA SPIFR) was studied. The objectives of the study were to (1) develop a GA SPIFR operational profile, (2) identify problems experienced by the GA SPIFR pilot, and (3) identify research tasks which have the potential for eliminating or reducing the severity of the problems. To obtain the information necessary to accomplish these objectives, a mail questionnaire survey of instrument rated pilots was conducted. The general aviation IFR single pilot operational profile and selected data analysis examples are presented.

Piloted studies of Enhanced or Synthetic Vision display parameters

NASA Technical Reports Server (NTRS)

Harris, Randall L., Sr.; Parrish, Russell V.

1992-01-01

This paper summarizes the results of several studies conducted at Langley Research Center over the past few years. The purposes of these studies were to investigate parameters of pictorial displays and imaging sensors that affect pilot approach and landing performance. Pictorial displays have demonstrated exceptional tracking performance and improved the pilots' spatial awareness. Stereopsis cueing improved pilot flight performance and reduced pilot stress. Sensor image parameters such as increased field-of-view. faster image update rate, and aiding symbology improved flare initiation. Finer image resolution and magnification improved attitude control performance parameters.

Low amyloid-β deposition correlates with high education in cognitively normal older adults: a pilot study.

PubMed

Yasuno, Fumihiko; Kazui, Hiroaki; Morita, Naomi; Kajimoto, Katsufumi; Ihara, Masafumi; Taguchi, Akihiko; Yamamoto, Akihide; Matsuoka, Kiwamu; Kosaka, Jun; Kudo, Takashi; Iida, Hidehiro; Kishimoto, Toshifumi

2015-09-01

Several epidemiological studies have found a lower incidence of Alzheimer's disease in highly educated populations, but the protective mechanism of education against the disease is still unclear. Our objective was to investigate the association between education and (11) C-labeled Pittsburgh Compound B (PIB) uptake with positron emission tomography in participants with normal cognitive ability. We performed (11) C-labeled PIB positron emission tomography and neuropsychological testing in 30 cognitively normal older participants. Of the participants, 16 had a period of education less than 12 years (low-education group) and 14 had more than 13 years (high-education group). Amyloid-β deposition was quantified by binding potential (BPND ) in several brain regions and was compared between the groups with different education levels. We found significantly higher cortical PIB-BPND in the cognitively normal participants with low education compared with the ones with high education. None of the brain regions in low-education group showed significantly lower BPND values. This finding was not affected by the inclusion of possible confounding variables such as age, sex, and general intelligence. Our findings indicated a reduced amyloid pathology in highly educated, cognitively normal, participants. Our findings lead to the proposal that early-life education has a negative association with Alzheimer's disease pathology. This proposal is not in opposition to the brain reserve hypothesis. People with more education might be prone to a greater inhibitory effect against amyloid-β deposition before the preclinical stage. At the same time, they have a greater reserve capacity, and greater pathological changes are required for dementia to manifest. Copyright © 2014 John Wiley & Sons, Ltd.

PILOT STUDY: THE TAMPA ASTHMATIC CHILDREN'S STUDY (TACS)

EPA Science Inventory

The Tampa Asthmatic Children's Study (TACS) was a pilot research study that focused on developing and evaluating air pollution exposure assessment methods and participant recruiting tools for children in the age range of 1-5 years old. The pilot study focused on (a) simple, cost-...

Correlates of nutrition label use among college students and young adults: a review.

PubMed

Christoph, Mary J; An, Ruopeng; Ellison, Brenna

2016-08-01

Nutrition labels are an essential source for consumers to obtain nutrition-related information on food products and serve as a population-level intervention with unparalleled reach. The present study systematically reviewed existing evidence on the correlates of nutrition label use among college students and young adults. Keyword and reference searches were conducted in PubMed, EBSCO, PsycInfo, Cochrane Library and Web of Science. Inclusion criteria included: study design (randomized controlled trial, cohort study, pre-post study or cross-sectional study); population (college students and young adults 18-30 years old); main outcome (nutrition label use); article type (peer-reviewed publication); and language (English). College/university. College students and young adults. Sixteen studies based on data from college surveys in four countries (USA, UK, Canada, South Korea) were identified from keyword and reference search. Reported prevalence of nutrition label use varied substantially across studies; a weighted average calculation showed 36·5 % of college students and young adults reported using labels always or often. Females were more likely to use nutrition labels than males. Nutrition label use was found to be associated with attitudes towards healthy diet, beliefs on the importance of nutrition labels in guiding food selection, self-efficacy, and nutrition knowledge and education. The impact of nutrition labelling on food purchase and intake could differ by population subgroups. Nutrition awareness campaigns and education programmes may be important mechanisms for promoting nutrition label use among college students and young adults. Future research is warranted to assess the role of label use on improved dietary decisions.

Field-Scale Evaluation of Monitored Natural Attenuation for Dissolved Chlorinated Solvent Plumes

DTIC Science & Technology

2009-04-01

biological in-situ treatment, an air sparging pilot study, and a phytoremediation study. The innovative technology studies were conducted within the source... phytoremediation (June to September 1997), reductive anaerobic biological in-situ treatment technology (RABITT; 1998), and groundwater recirculation wells...u g / L ) Measured Concentrations in 1381MWS09 Air Sparge Pilot Test (1996/1997) Phytoremediation Pilot Test (1997) RABITT Pilot Test (1998

The Necessity of ASEAN Community in Producing Pilots

ERIC Educational Resources Information Center

Saowaros, Thanoo; Puncreobutr, Vichian

2016-01-01

The main objectives of this study are to identify the reasons for the shortage of pilots; the necessity of producing Pilots and the obstacles and problems faced by ASEAN Community in producing pilots. The study is conducted by official documents, observations, in-depth interview from personnel who are working for Airports Authority of Thailand,…

SPEEDIER Project. Preliminary Report on Social Studies Pilot Projects.

ERIC Educational Resources Information Center

Myers, Charles B.; And Others

This preliminary report describes five social studies pilot programs in the counties of Dauphin, Lancaster, Lebanon, and York, Pennsylvania. It is expected that these pilot endeavors will affect educators in the counties served by SPEEDIER as follows: 1) increase understanding of the newer content, ideas, and strategies in the pilot programs; 2)…

Pilot Study: Foam Wedge Chin Support Static Tolerance Testing

DTIC Science & Technology

2017-10-24

AFRL-SA-WP-SR-2017-0026 Pilot Study : Foam Wedge Chin Support Static Tolerance Testing Austin M. Fischer, BS1; William W...COVERED (From – To) April – October 2017 4. TITLE AND SUBTITLE Pilot Study : Foam Wedge Chin Support Static Tolerance Testing 5a. CONTRACT NUMBER...prototype to mitigate the increase in helmet weight and forward center of gravity. The purpose of this pilot study was to determine the feasibility and

An analytical study of aircraft lateral-directional handling qualities using pilot models

NASA Technical Reports Server (NTRS)

Adams, J. J.; Moore, F. L.

1976-01-01

A procedure for predicting lateral-directional pilot ratings on the basis of the characteristics of the pilot model and the closed-loop system characteristics is demonstrated. A correlation is shown to exist between experimentally obtained pilot ratings and the computed pilot ratings.

[Are depression perceived by the public and depression described by DSM-III the same?].

PubMed

Kovess, V; Murphy, H B; Tousignant, M

1989-12-01

The public usage of the word depression does not correspond to the descriptions of depression proposed by classifications such as the DSM-III. Data from the pilot survey of Santé-Québec covering 3,291 persons distributed in two areas, one rural (D.S.C. of Rimouski) and other urban (D.S.C. of Verdun), allow to compare the use of the term depression between an informant reporting on a family member when this expression is included in a list of chronic illnesses, and an informant reporting on a self-administered questionnaire, symptoms similar to the diagnostics of depression and dysthymia of the DSM-III. Result show a low degree of correspondance between the term of depression as used by lay persons and as applied by medicine (14%); the small overlap mainly concerns the serious cases. Depression in its lay usage is refering less often to the psychic manifestations of the medical depression, i.e. lack of positive experiences, hopelessness, boredom, but it is often applied to persons who are not able any more to achieve social roles. The usage of the lay label varies according to sex and rural-urban origin. It applies more often to urban women under 40, even though these women are not showing the DSM-III signs of depression. On the other hand, rural men are almost never associated with this label even though a certain proportion meet the DSM-III criteria for depression. The discussion offers explanations for the different use of the label in urban and rural areas.

Use of insulin sensitizers for the treatment of major depressive disorder: a pilot study of pioglitazone for major depression accompanied by abdominal obesity.

PubMed

Kemp, David E; Ismail-Beigi, Faramarz; Ganocy, Stephen J; Conroy, Carla; Gao, Keming; Obral, Sarah; Fein, Elizabeth; Findling, Robert L; Calabrese, Joseph R

2012-02-01

This study was conducted to examine the safety and efficacy of pioglitazone, a thiazolidinedione insulin sensitizer, in adult outpatients with major depressive disorder. In a 12-week, open-label, flexible-dose study, 23 patients with major depressive disorder received pioglitazone monotherapy or adjunctive therapy initiated at 15 mg daily. Subjects were required to meet criteria for abdominal obesity (waist circumference>35 in. in women and >40 in. in men) or metabolic syndrome. The primary efficacy measure was the change from baseline to Week 12 on the Inventory of Depressive Symptomatology (IDS) total score. Partial responders (≥25% decrease in IDS total score) were eligible to participate in an optional extension phase for an additional three months. Pioglitazone decreased depression symptom severity from a total IDS score of 40.3±1.8 to 19.2±1.8 at Week 12 (p<.001). Among partial responders (≥25% decrease in IDS total score), an improvement in depressive symptoms was maintained during an additional 3-month extension phase (total duration=24 weeks) according to IDS total scores (p<.001). Patients experienced a reduction in insulin resistance from baseline to Week 12 according to the log homeostasis model assessment (-0.8±0.75; p<.001) and a significant reduction in inflammation as measured by log highly- sensitive C-reactive protein (-0.87±0.72; p<.001). During the current episode, the majority of participants (74%, n=17), had already failed at least one antidepressant trial. The most common side effects were headache and dizziness; no patient discontinued due to side effects. These data are limited by a small sample size and an open-label study design with no placebo control. Although preliminary, pioglitazone appears to reduce depression severity and improve several markers of cardiometabolic risk, including insulin resistance and inflammation. Larger, placebo-controlled studies are indicated. Copyright © 2011 Elsevier B.V. All rights reserved.

Synthesis and animal studies of L-para-(/sup 18/F)-fluorophenyl-alanine as probe for in vivo cerebral protein synthesis

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

Coenen, H.H.; Bodsch, W.; Takahashi, K.

For the quantitation of cerebral protein synthesis in man by dynamic PET studies, fluorine-18 analogues seem superior to carbon-11 labeled substrates with respect to half-life and interference of amino acid metabolism giving rise to reutilization. Therefore, para- and ortho- /sup 18/F- fluorophenylalanine were prepared to study its metabolism in neuronal tissue. A labeling method was developed using direct electrophilic fluorination with (/sup 18/F)-F/sub 2/. Reaction of fluorine with L-phenylalanine in CF/sub 3/CO/sub 2/H at O/sup 0/C yielded 12-15% of ortho- and 6-8% of para-/sup 18/F-flurorophenylalanine. Isolation of the isomers was achieved by means of repeated RP-HPLC. The specific activity wasmore » about 2 Ci/mmole at 100 min after EOB. Both compounds showed a pharmacokinetic behaviour in mice after i.v. injection typical for natural amino acids. The accumulation in mice brain tissue reaches a plateau value after 5 min with 1.7% of the injected dose/g for para (2.5% in gerbils) and 2% for ortho. In a pilot study, about 1 mCi of p-/sup 18/F-phenylalanine was coinjected with 0.3 mCi (100 Ci/mmole) /sup 3/H-phenylalanine into the femoral vein of halothane-anesthetized Mongolian gerbils. The distribution obtained autoradiographyically in 20 ..mu..m sections of the frozen brain of an animal after 45 min revealed a similar pattern for both compounds indicating protein synthesis. In a parallel study 3-/sup 14/C-para-fluorophenylalanine was used to determine the chemical form of radioactivity in brain by means of HPLC. After 45 minutes, 7% of total brain activity was found as free amino acid and 60% was incorporated into proteins.« less

Tocotrienol Treatment in Familial Dysautonomia: Open-Label Pilot Study.

PubMed

Cheishvili, David; Maayan, Channa; Holzer, Naama; Tsenter, Jeanna; Lax, Elad; Petropoulos, Sophie; Razin, Aharon

2016-07-01

Familial dysautonomia (FD) is an autosomal recessive congenital neuropathy, primarily presented in Ashkenazi Jews. The most common mutation in FD patients results from a single base pair substitution of an intronic splice site in the IKBKAP gene which disrupts normal mRNA splicing and leads to tissue-specific reduction of IKBKAP protein (IKAP). To date, treatment of FD patients remains preventative, symptomatic and supportive. Based on previous in vitro evidence that tocotrienols, members of the vitamin E family, upregulate transcription of the IKBKAP gene, we aimed to investigate whether a similar effects was observed in vivo. In the current study, we assessed the effects of tocotrienol treatment on FD patients' symptoms and IKBKAP expression in white blood cells. The initial daily doses of 50 or 100 mg tocotrienol, doubled after 3 months, was administered to 32 FD patients. Twenty-eight FD patients completed the 6-month study. The first 3 months of tocotrienol treatment was associated with a significant increase in IKBKAP expression level in FD patients' blood. Despite doubling the dose after the initial 3 months of treatment, IKBKAP expression level returned to baseline by the end of the 6-month treatment. Clinical improvement was noted in the reported clinical questionnaire (with regard to dizziness, bloching, sweating, number of pneumonia, cough episodes, and walking stability), however, no significant effect was observed in any clinical measurements (weight, height, oxygen saturation, blood pressure, tear production, histamine test, vibration threshold test, nerve conduction, and heart rate variability) following Tocotrienol treatment. In conclusion, tocotrienol treatment appears significantly beneficial by clinical evaluation for some FD patients in a few clinical parameters; however it was not significant by clinical measurements. This open-label study shows the complexity of effect of tocotrienol treatment on FD patients' clinical outcomes and on IKBKAP expression level compared to in vitro results. A longitudinal study with an increased sample size is required in the future to better understand tocotrienol affect on FD patients.

Comparison of a web-based food record tool and a food-frequency questionnaire and objective validation using the doubly labelled water technique in a Swedish middle-aged population.

PubMed

Nybacka, Sanna; Bertéus Forslund, Heléne; Wirfält, Elisabet; Larsson, Ingrid; Ericson, Ulrika; Warensjö Lemming, Eva; Bergström, Göran; Hedblad, Bo; Winkvist, Anna; Lindroos, Anna Karin

2016-01-01

Two web-based dietary assessment tools have been developed for use in large-scale studies: the Riksmaten method (4-d food record) and MiniMeal-Q (food-frequency method). The aim of the present study was to examine the ability of these methods to capture energy intake against objectively measured total energy expenditure (TEE) with the doubly labelled water technique (TEE DLW ), and to compare reported energy and macronutrient intake. This study was conducted within the pilot study of the Swedish CArdioPulmonary bioImage Study (SCAPIS), which included 1111 randomly selected men and women aged 50-64 years from the Gothenburg general population. Of these, 200 were enrolled in the SCAPIS diet substudy. TEE DLW was measured in a subsample ( n 40). Compared with TEE DLW , both methods underestimated energy intake: -2·5 (sd  2·9) MJ with the Riksmaten method; -2·3 (sd 3·6) MJ with MiniMeal-Q. Mean reporting accuracy was 80 and 82 %, respectively. The correlation between reported energy intake and TEE DLW was r 0·4 for the Riksmaten method ( P  < 0·05) and r 0·28 (non-significant) for MiniMeal-Q. Women reported similar average intake of energy and macronutrients in both methods whereas men reported higher intakes with the Riksmaten method. Energy-adjusted correlations ranged from 0·14 (polyunsaturated fat) to 0·77 (alcohol). Bland-Altman plots showed acceptable agreement for energy and energy-adjusted protein and carbohydrate intake, whereas the agreement for fat intake was poorer. According to energy intake data, both methods displayed similar precision on energy intake reporting. However, MiniMeal-Q was less successful in ranking individuals than the Riksmaten method. The development of methods to achieve limited under-reporting is a major challenge for future research.

Dynamic Tunnel Usability Study: Format Recommendations for Synthetic Vision System Primary Flight Displays

NASA Technical Reports Server (NTRS)

Arthur, Jarvis J., III; Prinzel, Lawrence J., III; Kramer, Lynda J.; Bailey, Randall E.

2006-01-01

A usability study evaluating dynamic tunnel concepts has been completed under the Aviation Safety and Security Program, Synthetic Vision Systems Project. The usability study was conducted in the Visual Imaging Simulator for Transport Aircraft Systems (VISTAS) III simulator in the form of questionnaires and pilot-in-the-loop simulation sessions. Twelve commercial pilots participated in the study to determine their preferences via paired comparisons and subjective rankings regarding the color, line thickness and sensitivity of the dynamic tunnel. The results of the study showed that color was not significant in pilot preference paired comparisons or in pilot rankings. Line thickness was significant for both pilot preference paired comparisons and in pilot rankings. The preferred line/halo thickness combination was a line width of 3 pixels and a halo of 4 pixels. Finally, pilots were asked their preference for the current dynamic tunnel compared to a less sensitive dynamic tunnel. The current dynamic tunnel constantly gives feedback to the pilot with regard to path error while the less sensitive tunnel only changes as the path error approaches the edges of the tunnel. The tunnel sensitivity comparison results were not statistically significant.

75 FR 45641 - Guidance for Industry on Label Comprehension Studies for Nonprescription Drug Products; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-03

...] Guidance for Industry on Label Comprehension Studies for Nonprescription Drug Products; Availability AGENCY... announcing the availability of a guidance for industry entitled ``Label Comprehension Studies for Nonprescription Drug Products.'' The guidance provides recommendations on the design of label comprehension...

Effects of alcohol on pilot performance in simulated flight

NASA Technical Reports Server (NTRS)

Billings, C. E.; Demosthenes, T.; White, T. R.; O'Hara, D. B.

1991-01-01

Ethyl alcohol's known ability to produce reliable decrements in pilot performance was used in a study designed to evaluate objective methods for assessing pilot performance. Four air carrier pilot volunteers were studied during eight simulated flights in a B727 simulator. Total errors increased linearly and significantly with increasing blood alcohol. Planning and performance errors, procedural errors and failures of vigilance each increased significantly in one or more pilots and in the group as a whole.

Protein 19F-labeling using transglutaminase for the NMR study of intermolecular interactions.

PubMed

Hattori, Yoshikazu; Heidenreich, David; Ono, Yuki; Sugiki, Toshihiko; Yokoyama, Kei-Ichi; Suzuki, Ei-Ichiro; Fujiwara, Toshimichi; Kojima, Chojiro

2017-08-01

The preparation of stable isotope-labeled proteins is important for NMR studies, however, it is often hampered in the case of eukaryotic proteins which are not readily expressed in Escherichia coli. Such proteins are often conveniently investigated following post-expression chemical isotope tagging. Enzymatic 15 N-labeling of glutamine side chains using transglutaminase (TGase) has been applied to several proteins for NMR studies. 19 F-labeling is useful for interaction studies due to its high NMR sensitivity and susceptibility. Here, 19 F-labeling of glutamine side chains using TGase and 2,2,2-trifluoroethylamine hydrochloride was established for use in an NMR study. This enzymatic 19 F-labeling readily provided NMR detection of protein-drug and protein-protein interactions with complexes of about 100 kDa since the surface residues provided a good substrate for TGase. The 19 F-labeling method was 3.5-fold more sensitive than 15 N-labeling, and could be combined with other chemical modification techniques such as lysine 13 C-methylation. 13 C-dimethylated- 19 F-labeled FKBP12 provided more accurate information concerning the FK506 binding site.

An experimental study of the effect of a pilot flame on technically pre-mixed, self-excited combustion instabilities

NASA Astrophysics Data System (ADS)

O'Meara, Bridget C.

Combustion instabilities are a problem facing the gas turbine industry in the operation of lean, pre-mixed combustors. Secondary flames known as "pilot flames" are a common passive control strategy for eliminating combustion instabilities in industrial gas turbines, but the underlying mechanisms responsible for the pilot flame's stabilizing effect are not well understood. This dissertation presents an experimental study of a pilot flame in a single-nozzle, swirl-stabilized, variable length atmospheric combustion test facility and the effect of the pilot on combustion instabilities. A variable length combustor tuned the acoustics of the system to excite instabilities over a range of operating conditions without a pilot flame. The inlet velocity was varied from 25 -- 50 m/s and the equivalence ratio was varied from 0.525 -- 0.65. This range of operating conditions was determined by the operating range of the combustion test facility. Stability at each operating condition and combustor length was characterized by measurements of pressure oscillations in the combustor. The effect of the pilot flame on the magnitude and frequency of combustor stability was then investigated. The mechanisms responsible for the pilot flame effect were studied using chemiluminescence flame images of both stable and unstable flames. Stable flame structure was investigated using stable flame images of CH* chemiluminescence emission. The effect of the pilot on stable flame metrics such as flame length, flame angle, and flame width was investigated. In addition, a new flame metric, flame base distance, was defined to characterize the effect of the pilot flame on stable flame anchoring of the flame base to the centerbody. The effect of the pilot flame on flame base anchoring was investigated because the improved stability with a pilot flame is usually attributed to improved flame anchoring through the recirculation of hot products from the pilot to the main flame base. Chemiluminescence images of unstable flames were used to identify several instability mechanisms and infer how these mechanisms are affected by the pilot flame. Flame images of cases in which the pilot flame did not eliminate the instability were investigated to understand why the pilot flame is not effective in certain cases. The phase of unstable pilot flame oscillations was investigated to determine how the phase of pilot flame oscillations may affect its ability to interfere with instability mechanisms in the main flame. A forced flame response study was conducted to determine the effect of inlet velocity oscillation amplitude on the pilot flame. The flame response was characterized by measurements of velocity oscillations in the injector and chemiluminescence intensity oscillations determined from flame images. As the forcing amplitude increases, the pilot flame's effect on the flame transfer function magnitude becomes weaker. Flame images show that as the forcing amplitude increases, the pilot flame oscillations increase, leading to an ineffective pilot. The results of the flame response portion of this study highlight the effect of instability amplitude on the ability of a pilot flame to eliminate a combustion instability.

Controlling road rage : a literature review and pilot study

DOT National Transportation Integrated Search

1999-06-01

This report discusses results of a literature review and pilot study on how to prevent aggressive driving and road rage. The study "Controlling Road Rage: A Literature Review and Pilot Study" defines road rage as "an incident in which an angry or imp...

Physiological studies on air tanker pilots flying forest fire retardant missions.

DOT National Transportation Integrated Search

1968-10-01

Pre-flight and post-flight studies were carried out on five air tanker pilots; in-flight studies were carried out on four of these five pilots. Pre- and post-flight studies consisted of a questionnaire and determinations of blood pressure, psychomoto...

Pilot study of once-daily simplification therapy with abacavir/lamivudine/zidovudine and efavirenz for treatment of HIV-1 infection.

PubMed

Ruane, Peter; Lang, Joseph; DeJesus, Edwin; Berger, Daniel S; Dretler, Robin; Rodriguez, Allan; Ward, Douglas J; Lim, Michael L; Liao, Qiming; Reddy, Sunila; Clair, Marty St; Vila, Tania; Shaefer, Mark S

2006-01-01

The purpose of this pilot study was to explore the efficacy and safety of the abacavir/lamivudine/zidovudine fixed-dose combination tablet administered as two tablets once daily (qd) versus one tablet twice daily (bid) in combination with efavirenz (EFV). This was a prospective, randomized, open-label, multicenter study with a 24-week treatment period in 7 outpatient HIV clinics in the United States. Patients currently receiving an initial regimen of abacavir/lamivudine/zidovudine bid plus EFV qd for at least 6 months with HIV-1 RNA <50 copies/mL for at least 3 months and a screening CD4+ cell count > or = 200 cells/mm3 were eligible. Thirty-six patients enrolled, and 35 (97%) completed the study. Participants were randomized to switch to 2 tablets of abacavir/lamivudine/zidovudine qd plus EFV qd (QD arm) or continue current treatment (BID arm) for 24 weeks. Efficacy, safety, and adherence were evaluated. Median baseline CD4+ cell count was 521 cells/mm3. At week 24, HIV-1 RNA <50 copies/mL was achieved for 94% of participants in the QD arm and 89% in the BID arm by intent-to-treat, missing = failure analysis (95% confidence interval for difference: > or = 0.29 to +0.18, p = 1.000). At week 24, median CD4+ cell count change from baseline was +26 cells/mm3 for the QD arm and -39 cells/mm3 for BID arm. One patient randomized to the QD arm met virologic failure criteria (confirmed HIV-1 RNA >120 copies/mL) at week 20 and viral genotype showed M184V. After failure, this patient revealed he never took EFV throughout the entire study after randomization, effectively receiving only abacavir/lamivudine/zidovudine qd alone. Median adherence was slightly higher in the QD arm, although both arms had broad variability and overlapping interquartile ranges. Adverse events were infrequent and occurred with similar frequency between arms; treatment-related adverse events were abdominal pain, flatulence, nausea, headache, and abnormal dreams (1 patient [3%] for each adverse event). No patients withdrew due to adverse events, and no abacavir hypersensitivity reactions were reported. In this pilot study of patients suppressed on abacavir/lamivudine/zidovudine bid plus EFV, 94% of participants switching to abacavir/lamivudine/zidovudine qd plus EFV maintained virologic suppression, compared to 89% of participants continuing abacavir/lamivudine/zidovudine bid plus EFV.

Study protocol of a pragmatic, randomised controlled pilot trial: clinical effectiveness on smoking cessation of traditional and complementary medicine interventions, including acupuncture and aromatherapy, in combination with nicotine replacement therapy

PubMed Central

Jang, Soobin; Park, Sunju; Jang, Bo-Hyoung; Park, Yu Lee; Lee, Ju Ah; Cho, Chung-Sik; Go, Ho-Yeon; Shin, Yong Cheol; Ko, Seong-Gyu

2017-01-01

Introduction Nicotine dependence is a disease, and tobacco use is related to 6 million deaths annually worldwide. Recently, in many countries, there has been growing interest in the use of traditional and complementary medicine (T&CM) methods, especially acupuncture, as therapeutic interventions for smoking cessation. The aim of this pilot study is to investigate the effectiveness of T&CM interventions on smoking cessation. Methods and analysis The STOP (Stop Tobacco Programme using traditional Korean medicine) study is designed to be a pragmatic, open-label, randomised pilot trial. This trial will evaluate whether adding T&CM methods (ie, ear and body acupuncture, aromatherapy) to conventional cessation methods (ie, nicotine replacement therapy (NRT), counselling) increases smoking cessation rates. Forty participants over 19 years old who are capable of communicating in Korean will be recruited. They will be current smokers who meet one of the following criteria: (1) smoke more than 10 cigarettes a day, (2) smoke less than 10 cigarettes a day and previously failed to cease smoking, or (3) smoke fewer than 10 cigarettes a day and have a nicotine dependence score (Fagerstrom Test for Nicotine Dependence) of 4 points or more. The trial will consist of 4 weeks of treatment and a 20 week follow-up period. A statistician will perform the statistical analyses for both the intention-to-treat (all randomly assigned participants) and per-protocol (participants who completed the trial without any protocol deviations) data using SAS 9.1.3. Ethics and dissemination This study has been approved by the Institutional Review Board (IRB) of the Dunsan Korean Medicine Hospital of Daejeon University (IRB reference no: DJDSKH-15-BM-11–1, Protocol No. version 4.1.).The protocol will be reapproved by IRB if it requires amendment. The trial will be conducted according to the Declaration of Helsinki, 7th version (2013). This study is designed to minimise the risk to participants, and the investigators will explain the study to the participants in detail. As an ethical clinical trial, the control group will also be given conventional cessation treatments, including NRT and counselling. Participants will be screened and provided with a registration number to protect their personal information. Informed consent will be obtained from the participants prior to enrolling them in the trial. Participants will be allowed to withdraw at anytime without penalty. Trial registration number ClinicalTrials.gov (NCT02768025); pre-results. PMID:28576892

What is prescription labeling communicating to doctors about hepatotoxic drugs? A study of FDA approved product labeling.

PubMed

Willy, Mary E; Li, Zili

2004-04-01

The objective of this study was to evaluate the informativeness and consistency of product labeling of hepatotoxic drugs marketed in the United States. We searched the Physicians' Desk Reference-2000 for prescription drugs with hepatic failure and/or hepatic necrosis listed in the labeling. We used a six-item checklist to evaluate the 'informativeness' and consistency of the labeling content. An informativeness score equaled the proportion of checklist items present in each drug's labeling. Ninety-five prescription drugs were included in the study. Eleven (12%) of the drugs had information related to hepatic failure in a Black Boxed Warning, 52 (54%) in the Warnings section and 32 (34%) in the Adverse Reactions section of the label. The mean informativeness score was 35%; the score was significantly higher, 61%, when the risk was perceived to be high. The informativeness of labeling was not affected by the time of the labeling, but differed across the Center for Drug Evaluation and Research (CDER) Review Division responsible for the labeling. The information provided in labeling is variable and affected by many factors, including the perceived level of risk and review division strategy. Product labeling may benefit from current FDA initiatives to improve the consistency of risk-related labeling.

Lessons from a One-to-One Laptop Pilot

ERIC Educational Resources Information Center

Peterson, Lana; Scharber, Cassandra

2017-01-01

The purpose of this study was to document the process one district used to design, develop, and implement a one-to-one pilot at its high school as part of its broader commitment to contemporary learning. Specifically, this qualitative case study (a) outlines the process of the laptop pilot, (b) describes the pilot implementation experience for…

Do nutrition labels influence healthier food choices? Analysis of label viewing behaviour and subsequent food purchases in a labelling intervention trial.

PubMed

Ni Mhurchu, Cliona; Eyles, Helen; Jiang, Yannan; Blakely, Tony

2018-02-01

There are few objective data on how nutrition labels are used in real-world shopping situations, or how they affect dietary choices and patterns. The Starlight study was a four-week randomised, controlled trial of the effects of three different types of nutrition labels on consumer food purchases: Traffic Light Labels, Health Star Rating labels, or Nutrition Information Panels (control). Smartphone technology allowed participants to scan barcodes of packaged foods and receive randomly allocated labels on their phone screen, and to record their food purchases. The study app therefore provided objectively recorded data on label viewing behaviour and food purchases over a four-week period. A post-hoc analysis of trial data was undertaken to assess frequency of label use, label use by food group, and association between label use and the healthiness of packaged food products purchased. Over the four-week intervention, study participants (n = 1255) viewed nutrition labels for and/or purchased 66,915 barcoded packaged products. Labels were viewed for 23% of all purchased products, with decreasing frequency over time. Shoppers were most likely to view labels for convenience foods, cereals, snack foods, bread and bakery products, and oils. They were least likely to view labels for sugar and honey products, eggs, fish, fruit and vegetables, and meat. Products for which participants viewed the label and subsequently purchased the product during the same shopping episode were significantly healthier than products where labels were viewed but the product was not subsequently purchased: mean difference in nutrient profile score -0.90 (95% CI -1.54 to -0.26). In a secondary analysis of a nutrition labelling intervention trial, there was a significant association between label use and the healthiness of products purchased. Nutrition label use may therefore lead to healthier food purchases. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

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

Buchholz, Stuart A.

This memorandum documents laboratory thermomechanical triaxial strength testing of Waste Isolation Pilot Plant (WIPP) clean salt. The limited study completed independent, adjunct laboratory tests in the United States to assist in validating similar testing results being provided by the German facilities. The testing protocol consisted of completing confined triaxial, constant strain rate strength tests of intact WIPP clean salt at temperatures of 25°C and 100°C and at multiple confining pressures. The stratigraphy at WIPP also includes salt that has been labeled “argillaceous.” The much larger test matrix conducted in Germany included both the so-called clean and argillaceous salts. When combined,more » the total database of laboratory results will be used to develop input parameters for models, assess adequacy of existing models, and predict material behavior. These laboratory studies are also consistent with the goals of the international salt repository research program. The goal of this study was to complete a subset of a test matrix on clean salt from the WIPP undertaken by German research groups. The work was performed at RESPEC in Rapid City, South Dakota. A rigorous Quality Assurance protocol was applied, such that corroboration provides the potential of qualifying all of the test data gathered by German research groups.« less

Oral administration of a curcumin-phospholipid formulation (Meriva®) for treatment of chronic diabetic macular edema: a pilot study.

PubMed

Mazzolani, F; Togni, S; Giacomelli, L; Eggenhoffner, R; Franceschi, F

2018-06-01

The purpose of this open-label study was to investigate the effect of a curcumin-phospholipid lecithin formulation (Meriva®) on visual acuity and optical coherence tomography (OCT) retinal thickness in patients with chronic diabetic macular edema. Curcumin-phospholipid lecithin formulation (Meriva®, Indena S.p.A, Milan, Italy) was administered as tablets (Norflo®, Eye Pharma, Genoa, Italy) twice a day. Visual acuity and macular edema as measured by OCT before and after curcumin-phospholipid formulation treatment were assessed. The study included 12 eyes from 11 patients who completed at least a 3-month follow-up period. After 3 months of therapy, no eyes showed reduction in visual acuity, 16% showed stabilization, and 84% showed improvement. The improvement was statistically significant (p = 0.0072). After 3 months of therapy, 92% of eyes showed reduction of macula edema, 8% showed stabilization, and 0% showed an increase (p = 0.009). Our results, albeit preliminary, suggest that a curcumin-phospholipid formulation (Meriva®), administered as Norflo® tablets, may be feasible in the improvement of visual acuity and reduction of macular edema in patients with diabetic retinopathy.

Pilot Non-Conformance to Alerting System Commands

NASA Technical Reports Server (NTRS)

Pritchett, Amy R.; Hansman, R. John

1997-01-01

Instances of pilot non-conformance to alerting system commands have been identified in previous studies. Pilot non-conformance changes the final behavior of the system, and therefore may reduce actual performance from that anticipated. A simulator study has examined pilot non-conformance, using the task of collision avoidance during closely spaced parallel approaches as a case study. Consonance between the display and the alerting system was found to significantly improve subject agreement with automatic alerts. Based on these results, a more general discussion of the factors involved in pilot conformance is given, and design guidelines for alerting systems are given.

Pilot error in air carrier accidents: does age matter?

PubMed

Li, Guohua; Grabowski, Jurek G; Baker, Susan P; Rebok, George W

2006-07-01

The relationship between pilot age and safety performance has been the subject of research and controversy since the "Age 60 Rule" became effective in 1960. This study aimed to examine age-related differences in the prevalence and patterns of pilot error in air carrier accidents. Investigation reports from the National Transportation Safety Board for accidents involving Part 121 operations in the United States between 1983 and 2002 were reviewed to identify pilot error and other contributing factors. Accident circumstances and the presence and type of pilot error were analyzed in relation to pilot age using Chi-square tests. Of the 558 air carrier accidents studied, 25% resulted from turbulence, 21% from mechanical failure, 16% from taxiing events, 13% from loss of control at landing or takeoff, and 25% from other causes. Accidents involving older pilots were more likely to be caused by turbulence, whereas accidents involving younger pilots were more likely to be taxiing events. Pilot error was a contributing factor in 34%, 38%, 35%, and 34% of the accidents involving pilots ages 25-34 yr, 35-44 yr, 45-54 yr, and 55-59 yr, respectively (p = 0.87). The patterns of pilot error were similar across age groups. Overall, 26% of the pilot errors identified were inattentiveness, 22% flawed decisions, 22% mishandled aircraft kinetics, and 11% poor crew interactions. The prevalence and patterns of pilot error in air carrier accidents do not seem to change with pilot age. The lack of association between pilot age and error may be due to the "safe worker effect" resulting from the rigorous selection processes and certification standards for professional pilots.

Massage therapy and exercise therapy in patients with multiple sclerosis: a randomized controlled pilot study.

PubMed

Negahban, Hossein; Rezaie, Solmaz; Goharpey, Shahin

2013-12-01

The primary aim was to investigate the comparative effects of massage therapy and exercise therapy on patients with multiple sclerosis. The secondary aim was to investigate whether combination of both massage and exercise has an additive effect. Randomized controlled pilot trial with repeated measurements and blinded assessments. Local Multiple Sclerosis Society. A total of 48 patients with multiple sclerosis were randomly assigned to four equal subgroups labelled as massage therapy, exercise therapy, combined massage-exercise therapy and control group. The treatment group received 15 sessions of supervised intervention for five weeks. The massage therapy group received a standard Swedish massage. The exercise therapy group was given a combined set of strength, stretch, endurance and balance exercises. Patients in the massage-exercise therapy received a combined set of massage and exercise treatments. Patients in the control group were asked to continue their standard medical care. Pain, fatigue, spasticity, balance, gait and quality of life were assessed before and after intervention. Massage therapy resulted in significantly larger improvement in pain reduction (mean change 2.75 points, P = 0.001), dynamic balance (mean change, 3.69 seconds, P = 0.009) and walking speed (mean change, 7.84 seconds, P = 0.007) than exercise therapy. Patients involved in the combined massage-exercise therapy showed significantly larger improvement in pain reduction than those in the exercise therapy (mean change, 1.67 points, P = 0.001). Massage therapy could be more effective than exercise therapy. Moreover, the combination of massage and exercise therapy may be a little more effective than exercise therapy alone.

Optimization and quality assessment of the post-digestion 18O labeling based on urea for protein denaturation by HPLC/ESI-TOF mass spectrometry.

PubMed

Wang, Hongbin; Hu, Gaofei; Zhang, Yongqian; Yuan, Zheng; Zhao, Xuan; Zhu, Yong; Cai, De; Li, Yujuan; Xiao, Shengyuan; Deng, Yulin

2010-07-15

The post-digestion (18)O labeling method decouples protein digestion and peptide labeling. This method allows labeling conditions to be optimized separately and increases labeling efficiency. A common method for protein denaturation in proteomics is the use of urea. Though some previous studies have used urea-based protein denaturation before post-digestion (18)O labeling, the optimal (18)O labeling conditions in this case have not been yet reported. Present study investigated the effects of urea concentration and pH on the labeling efficiency and obtained an optimized protocol. It was demonstrated that urea inhibited (18)O incorporation depending on concentration. However, a urea concentration between 1 and 2M had minimal effects on labeling. It was also demonstrated that the use of FA to quench the digestion reaction severely affected the labeling efficiency. This study revealed the reason why previous studies gave different optimal pH for labeling. They neglect the effects of different digestion conditions on the labeling conditions. Excellent labeling quality was obtained at the optimized conditions using urea 1-2 M and pH 4.5, 98.4+/-1.9% for a standard protein mixture and 97.2+/-6.2% for a complex biological sample. For a 1:1 mixture analysis of the (16)O- and (18)O-labeled peptides from the same protein sample, the average abundance ratios reached 1.05+/-0.31, demonstrating a good quantitation quality at the optimized conditions. This work will benefit other researchers who pair urea-based protein denaturation with a post-digestion (18)O labeling method. 2010 Elsevier B.V. All rights reserved.

An exploratory study of drinkers views of health information and warning labels on alcohol containers.

PubMed

Thomson, Lisa M; Vandenberg, Brian; Fitzgerald, John L

2012-03-01

To identify general and specific features of health information warning labels on alcohol beverage containers that could potentially inform the development and implementation of a new labelling regime in Australia. Mixed methods, including a cross-sectional population survey and a qualitative study of knowledge, attitudes and behaviours regarding alcohol beverage labelling. The population survey used computer-assisted telephone interviews of 1500 persons in Victoria, Australia to gauge the level of support for health information and warning labels. The qualitative study used six focus groups to test the suitability of 12 prototype labels that were placed in situ on a variety of alcohol beverage containers. The telephone survey found 80% to 90% support for a range of information that could potentially be mandated by government authorities for inclusion on labels (nutritional information, alcohol content, health warning, images). Focus group testing of the prototype label designs found that labels should be integrated with other alcohol-related health messages, such as government social advertising campaigns, and specific labels should be matched appropriately to specific consumer groups and beverage types. There are high levels of public support for health information and warning labels on alcohol beverages. This study contributes much needed empirical guidance for developing alcohol beverage labelling strategies in an Australian context. © 2011 Australasian Professional Society on Alcohol and other Drugs.

77 FR 13343 - Pilot Program for Early Feasibility Study Investigational Device Exemption Applications...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-06

...] Pilot Program for Early Feasibility Study Investigational Device Exemption Applications; Termination of... acceptance of nominations for the Early Feasibility Study Investigational Device Exemption (IDE) Applications... technologies to participate in a pilot program for early feasibility study IDE applications. FDA is also...

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.

Pilot study of safety and efficacy of polyprenols in combination with coenzyme Q10 in patients with statin-induced myopathy.

PubMed

Latkovskis, Gustavs; Saripo, Vita; Sokolova, Emma; Upite, Dana; Vanaga, Ilona; Kletnieks, Ugis; Erglis, Andrejs

2016-01-01

Statin-induced myopathy (SIM) has been partially attributed to deficiency of dolichol and coenzyme Q10 (CoQ10). We aimed to test the safety and efficacy of plant polyprenols in combination with CoQ10 for alleviation of SIM. In an open-label, one-center prospective pilot study patients with SIM received conifer-tree needle polyprenols (4mg/day) and CoQ10 (100mg/day) for 8 weeks. Symptoms and safety were evaluated according to symptom severity score (0-10), creatine kinase (CK) levels, exercise test, dynamometry, complete blood count, clinical biochemistry and electrocardiography. Of the 14 patients, 11 completed the study per protocol. Two patients withdrew consent due to travels abroad, and it was discontinued for one patient with stage 3 chronic kidney disease due to asymptomatic elevations of liver enzymes at week 4. No safety parameters changed significantly in per protocol group. Non-significant increase of CK levels was observed (P=0.231). Muscle pain (n=10) and weakness (n=7) scores improved significantly (P<0.001 and P=0.018, respectively). Muscle pain completely disappeared in 2 patients, weakness resolved in 3 patients and cramps disappeared in two patients. Four patients assessed improvement strong enough to consider increase of statin dose. No changes were observed in exercise test or dynamometry. Conifer-tree polyprenols in combination with CoQ10 may be generally safe in patients with SIM, but caution should be exercised in patients with glomerular filtration rate <60mL/min and routine monitoring of the liver enzymes and CK is advocated in all patients. The observed efficacy provides the rationale for a larger, double-blind controlled study with polyprenols. Copyright © 2016 The Lithuanian University of Health Sciences. Production and hosting by Elsevier Urban & Partner Sp. z o.o. All rights reserved.

Effects of Maternal Iodine Nutrition and Thyroid Status on Cognitive Development in Offspring: A Pilot Study.

PubMed

Moleti, Mariacarla; Trimarchi, Francesco; Tortorella, Gaetano; Candia Longo, Alice; Giorgianni, Grazia; Sturniolo, Giacomo; Alibrandi, Angela; Vermiglio, Francesco

2016-02-01

Maternal iodine nutrition and thyroid status may influence neurocognitive development in offspring. This study investigated the effects on the intelligence quotient (IQ) of children born to mothers with different levels of iodine supplementation, with or without the administration of levothyroxine (LT4), prior to and during pregnancy. This pilot, prospective, observational study included four study groups, each comprising 15 mother-child pairs, identified on the basis of maternal histories of iodized salt consumption and LT4 treatment prior to and during pregnancy. The groups were labeled as follows: iodine (I), no iodine (no-I), iodine + LT4 (I + T4), and no iodine + LT4 (no-I + T4). IQ tests were administered to children at 6-12 years of age with the Wechsler Intelligence Scale for Children-3rd Edition (WISC-III), with full-scale IQ (FSIQ), verbal IQ (VIQ), and performance IQ (PIQ) being evaluated. Children of I and I + T4 mothers had similar verbal, performance, and FSIQs, which were 14, 10, and 13 points higher, respectively, than children born to no-I and no-I + T4 mothers. A positive association was found between VIQ and maternal urinary iodine (β = 1.023 [confidence interval (CI) 1.003-1.043]; p = 0.028), but not with maternal free thyroxine concentrations at any stage of pregnancy. Overall, the prevalence of borderline or defective cognitive function was more than threefold higher in the children of mothers not using iodized salt than of those mothers using it (76.9% vs. 23.1%, odds ratio 7.667 [CI 2.365-24.856], χ2 = 12.65; p = 0.0001). Neuro-intellectual outcomes in children appear to be more dependent on their mothers' nutritional iodine status than on maternal thyroid function. These results support the growing body of evidence that prenatal, mild-to-moderate iodine deficiency adversely affects cognitive development later in life, with a seemingly greater impact on verbal abilities.

Two-year results after convective radiofrequency water vapor thermal therapy of symptomatic benign prostatic hyperplasia.

PubMed

Dixon, Christopher M; Cedano, Edwin Rijo; Pacik, Dalibor; Vit, Vítězslav; Varga, Gabriel; Wagrell, Lennart; Larson, Thayne R; Mynderse, Lance A

2016-01-01

The objective of this study was to assess the effectiveness and safety of convective radiofrequency (RF) water vapor thermal therapy in men with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH); a pilot study design with 2-year follow-up evaluations. Men aged ≥45 years with an International Prostate Symptom Score ≥13, a maximum urinary flow rate (Q max ) ≤15 mL/s, and prostate volume 20-120 cc were enrolled in a prospective, open-label pilot study using convective RF water vapor energy with the Rezūm System. Patients were followed up for 2 years after transurethral thermal treatment at 3 international centers in the Dominican Republic, Czech Republic, and Sweden. The transurethral thermal therapy utilizes radiofrequency to generate wet thermal energy in the form of water vapor injected through a rigid endoscope into the lateral lobes and median lobe as needed. Urinary symptom relief, urinary flow, quality of life (QOL) impact, sexual function, and adverse events (AEs) were assessed at 1 week, 1, 3, 6, 12, and 24 months. LUTS, flow rate, and QOL showed significant improvements from baseline; prostate volumes were appreciably reduced. Sexual function was maintained and no de novo erectile dysfunction occurred. The responses evident as early as 1 month after treatment remained consistent and durable over the 24 months of study. Early AEs were typically transient and mild to moderate; most were related to endoscopic instrumentation. No procedure related to late AEs were seen. The Rezūm System convective RF thermal therapy is a minimally invasive treatment for BPH/LUTS which can be performed in the office or as an outpatient procedure with minimal associated perioperative AEs. It has no discernable effect on sexual function and provides significant improvement of LUTS that remain durable at 2 years.

A comparative assessment of the price, brands and pack characteristics of illicitly traded cigarettes in five cities and towns in South Africa

PubMed Central

Wherry, Anna E; McCray, Cheyenne A; Adedeji-Fajobi, Temidayo I; Sibiya, Xolani; Ucko, Peter; Lebina, Limakatso; Golub, Jonathan E; Cohen, Joanna E; Martinson, Neil A

2014-01-01

Objective The prevalence of illicitly traded cigarettes in South Africa has been reported to be 40–50%. However, these estimates do not account for the more nuanced characteristics of the illicit cigarette trade. With the goal of better understanding contraband cigarettes in South Africa, this study piloted three methods for assessing the price, brands, pack features and smoker's views about illicit cigarettes in five cities/towns. Data were collected in June and July 2012. Setting A convenience sample of three South African cities (Johannesburg, Durban and Nelspruit) and two smaller towns (Musina and Ficksburg) were chosen for this study. Outcome measures Three cross-sectional approaches were used to assess the characteristics of contraband cigarettes: (1) a dummy purchase of cigarettes from informal retailers, (2) the collection of discarded cigarette packs and (3) a survey of tobacco smokers. Participants For the purposes of the survey, 40 self-reported smokers were recruited at taxi ranks in each downtown site. Adults who were over the age of 18 were asked to verbally consent to participate in the study and answer a questionnaire administered by a researcher. Results The leading reason for labelling a pack as illicit in each city/town was the absence of an excise stamp (28.6% overall), and the least common reason was an illegal tar or nicotine level (11.1% overall). The overall proportion of informal vendors who sold illicit cigarettes was 41%. Singles and packs of 20 were consistently cheaper at informal vendors. Survey participants’ responses reflected varied perspectives on illicit cigarettes and purchasing preferences. Conclusions Each approach generated an interesting insight into physical aspects of illicit cigarettes. While this pilot study cannot be used to generate generalisable statistics on illicit cigarettes, more systematic surveys of this nature could inform researchers’ and practitioners’ initiatives to combat illicit and legal cigarette sales and usage. PMID:24812192

Two-year results after convective radiofrequency water vapor thermal therapy of symptomatic benign prostatic hyperplasia

PubMed Central

Dixon, Christopher M; Cedano, Edwin Rijo; Pacik, Dalibor; Vit, Vítězslav; Varga, Gabriel; Wagrell, Lennart; Larson, Thayne R; Mynderse, Lance A

2016-01-01

Objective The objective of this study was to assess the effectiveness and safety of convective radiofrequency (RF) water vapor thermal therapy in men with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH); a pilot study design with 2-year follow-up evaluations. Patients and methods Men aged ≥45 years with an International Prostate Symptom Score ≥13, a maximum urinary flow rate (Qmax) ≤15 mL/s, and prostate volume 20–120 cc were enrolled in a prospective, open-label pilot study using convective RF water vapor energy with the Rezūm System. Patients were followed up for 2 years after transurethral thermal treatment at 3 international centers in the Dominican Republic, Czech Republic, and Sweden. The transurethral thermal therapy utilizes radiofrequency to generate wet thermal energy in the form of water vapor injected through a rigid endoscope into the lateral lobes and median lobe as needed. Urinary symptom relief, urinary flow, quality of life (QOL) impact, sexual function, and adverse events (AEs) were assessed at 1 week, 1, 3, 6, 12, and 24 months. Results LUTS, flow rate, and QOL showed significant improvements from baseline; prostate volumes were appreciably reduced. Sexual function was maintained and no de novo erectile dysfunction occurred. The responses evident as early as 1 month after treatment remained consistent and durable over the 24 months of study. Early AEs were typically transient and mild to moderate; most were related to endoscopic instrumentation. No procedure related to late AEs were seen. Conclusion The Rezūm System convective RF thermal therapy is a minimally invasive treatment for BPH/LUTS which can be performed in the office or as an outpatient procedure with minimal associated perioperative AEs. It has no discernable effect on sexual function and provides significant improvement of LUTS that remain durable at 2 years. PMID:27921028

Copper absorption from foods labelled intrinsically and extrinsically with Cu-65 stable isotope.

PubMed

Harvey, L J; Dainty, J R; Beattie, J H; Majsak-Newman, G; Wharf, S G; Reid, M D; Fairweather-Tait, S J

2005-03-01

To determine copper absorption from copper containing foods labelled either intrinsically or extrinsically with a highly enriched Cu-65 stable isotope label. A longitudinal cross-over study. The study was conducted at the Institute of Food Research, Human Nutrition Unit, Norwich, UK. Subjects were recruited locally via advertisements placed around the Norwich Research Park. A total of 10 volunteers (nine female, one male) took part in the study, but not all volunteers completed each of the test meals. A highly enriched Cu-65 stable isotope label was administered to volunteers in the form of a reference dose or in breakfast test meals consisting of red wine, soya beans, mushrooms or sunflower seeds. Faecal monitoring and mass spectrometry techniques were used to estimate the relative quantities of copper absorbed from the different test meals. True copper absorption from the reference dose (54%) was similar to extrinsically labelled red wine (49%) and intrinsically labelled sunflower seeds (52%), but significantly higher than extrinsically labelled mushrooms (35%), intrinsically (29%) and extrinsically (15%) labelled soya beans and extrinsically labelled sunflower seed (32%) test meals. The use of Cu-65 extrinsic labels in copper absorption studies requires validation according to the food being examined; intrinsic and extrinsic labelling produced significantly different results for sunflower seeds.

Autogenic Feedback Training Exercise and pilot performance: enhanced functioning under search-and-rescue flying conditions.

PubMed

Cowings, P S; Kellar, M A; Folen, R A; Toscano, W B; Burge, J D

2001-01-01

Studies have shown that autonomous mode behavior is one cause of aircraft fatalities due to pilot error. In such cases, the pilot is in a high state of psychological and physiological arousal and tends to focus on one problem, while ignoring more critical information. This study examined the effect of training in physiological self-recognition and regulation, as a means of improving crew cockpit performance. Seventeen pilots were assigned to the treatment and control groups matched for accumulated flight hours. The treatment group contained 4 pilots from HC-130 Hercules aircraft and 4 HH-65 Dolphin helicopter pilots; the control group contained 3 pilots of HC-130s and 6 helicopter pilots. During an initial flight, physiological data were recorded on each crewmember and an instructor pilot rated individual crew performance. Eight crewmembers were then taught to regulate their own physiological response levels using Autogenic-Feedback Training Exercise (AFTE). The remaining participants received no training. During a second flight, treatment participants showed significant improvement in performance (rated by the same instructor pilot as in pretests) while controls did not improve. The results indicate that AFTE management of high states of physiological arousal may improve pilot performance during emergency flying conditions.

Autogenic Feedback Training Exercise and pilot performance: enhanced functioning under search-and-rescue flying conditions

NASA Technical Reports Server (NTRS)

Cowings, P. S.; Kellar, M. A.; Folen, R. A.; Toscano, W. B.; Burge, J. D.

2001-01-01

Studies have shown that autonomous mode behavior is one cause of aircraft fatalities due to pilot error. In such cases, the pilot is in a high state of psychological and physiological arousal and tends to focus on one problem, while ignoring more critical information. This study examined the effect of training in physiological self-recognition and regulation, as a means of improving crew cockpit performance. Seventeen pilots were assigned to the treatment and control groups matched for accumulated flight hours. The treatment group contained 4 pilots from HC-130 Hercules aircraft and 4 HH-65 Dolphin helicopter pilots; the control group contained 3 pilots of HC-130s and 6 helicopter pilots. During an initial flight, physiological data were recorded on each crewmember and an instructor pilot rated individual crew performance. Eight crewmembers were then taught to regulate their own physiological response levels using Autogenic-Feedback Training Exercise (AFTE). The remaining participants received no training. During a second flight, treatment participants showed significant improvement in performance (rated by the same instructor pilot as in pretests) while controls did not improve. The results indicate that AFTE management of high states of physiological arousal may improve pilot performance during emergency flying conditions.

EXPOSURE ASSESSMENT METHODS DEVELOPMENT PILOTS FOR THE NATIONAL CHILDREN'S STUDY

EPA Science Inventory

Accurate exposure classification tools are needed to link exposure with health effects. EPA began methods development pilot studies in 2000 to address general questions about exposures and outcome measures. Selected pilot studies are highlighted in this poster. The “Literature Re...

America and the age of genocide: labeling a third-party conflict "genocide" decreases support for intervention among ingroup-glorifying Americans because they down-regulate guilt and perceived responsibility to intervene.

PubMed

Leidner, Bernhard

2015-12-01

Drawing on research on the collapse of compassion and group processes and interrelations, four experiments investigated how labeling a conflict "genocide" affects distant bystanders' support for intervention. The genocide label (compared with no label or the label "not a genocide") weakened Americans' support for intervention in a crisis analogous to Darfur. Ingroup glorification moderated this effect such that the genocide label decreased support at high levels of glorification (Studies 1-3). Ingroup attachment, if anything, moderated such that the genocide label increased support at high levels of attachment (Studies 1 and 3). Importantly, the effects occurred even when controlling for conservatism (Studies 1 and 3), gender, religion, military affiliation, and level of education (Study 2). Decreases in anticipated guilt over possible nonintervention (Studies 1 and 3) among high glorifiers, and a subsequent decrease in perceived obligation to intervene (Study 3), mediated the effect of the genocide label on support for intervention. © 2015 by the Society for Personality and Social Psychology, Inc.

Prevalence of fatigue in a group of airline pilots.

PubMed

Reis, Cátia; Mestre, Catarina; Canhão, Helena

2013-08-01

Fatigue is a common phenomenon in airline pilots that can impair alertness and ability of crewmembers to safely operate an aircraft and perform safety related tasks. Fatigue can increase the risk of an incident or even an accident. This study provides the first prevalence values for clinically significant fatigue in Portuguese airline pilots. The hypothesis that medium/short-haul pilots may currently present different levels of fatigue than long-haul pilots was also tested. A survey was conducted by requesting Portuguese airline pilots to complete questionnaires placed in the pilots' personal lockers from 1 April until 15 May 2012. The questionnaire included the self-response Fatigue Severity Scale (FSS) to measure subjective fatigue and some additional questions concerning perception of fatigue by pilots. The prevalence values for total and mental fatigue achieved in the Portuguese airline pilots were: 89.3% (FSS > or = 4) and 94.1% (FSS > or = 4) when splitting the sample in two subsamples, long- and medium/short-haul pilots. Levels of total and mental fatigue were higher for medium/short-haul pilots. The analysis of fatigue levels in each type of aviator showed that medium/short-haul pilots presented the highest levels of total and mental fatigue. This study produced the first prevalence values of total and mental fatigue among Portuguese airline pilots, which represents a great step to understanding and addressing this critical phenomenon.

76 FR 12367 - Proposed Information Collection; Visibility Valuation Survey Pilot Study

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-07

... Survey Pilot Study AGENCY: National Park Service, U.S. Department of the Interior. ACTION: Notice... Code of Federal Regulations). Updated estimates of visibility benefits are required because the studies... a pilot study to test the survey instrument and implementation procedures prior to the full survey...

Pre-Study Walkthrough with a Commercial Pilot for a Preliminary Single Pilot Operations Experiment

NASA Technical Reports Server (NTRS)

O'Connor-Dreher, Ryan; Roberts, Z.; Ziccardi, J.; Vu, K-P. L.; Strybel, T.; Koteskey, Robert William; Lachter, Joel B.; Vi Dao, Quang; Johnson, Walter W.; Battiste, V.

2013-01-01

The number of crew members in commercial flights has decreased to two members, down from the five-member crew required 50 years ago. One question of interest is whether the crew should be reduced to one pilot. In order to determine the critical factors involved in safely transitioning to a single pilot, research must examine whether any performance deficits arise with the loss of a crew member. With a concrete understanding of the cognitive and behavioral role of a co-pilot, aeronautical technologies and procedures can be developed that make up for the removal of the second aircrew member. The current project describes a pre-study walkthrough process that can be used to help in the development of scenarios for testing future concepts and technologies for single pilot operations. Qualitative information regarding the tasks performed by the pilots can be extracted with this technique and adapted for future investigations of single pilot operations.

Iron and attention deficit/hyperactivity disorder: What is the empirical evidence so far? A systematic review of the literature.

PubMed

Cortese, Samuele; Angriman, Marco; Lecendreux, Michel; Konofal, Eric

2012-10-01

The authors systematically reviewed evidence on iron status, as well as studies of iron supplementation, in individuals with attention deficit/hyperactivity disorder (ADHD). PubMed, Ovid, EMBASE and Web of Knowledge were searched on 4 July 2012. Quantitative appraisal of trials was performed using Jadad's score. Most (n = 20) of the retrieved studies assessed an index of peripheral iron status (i.e., serum ferritin), with overall mixed results - that is, both significant and nonsignificant association between ADHD symptoms and serum ferritin levels. One MRI study reported significantly lower indices of thalamic iron in ADHD versus comparison subjects. Two trials, an open-label and a pilot randomized placebo-controlled study with high Jaded score (4), showed improvement in some but not all measures of ADHD symptoms. Three studies showed that children with ADHD plus sleep disorders, in particular restless legs syndrome, are at risk of iron deficiency. Finally, two studies suggested that iron deficiency might decrease the effectiveness of psychostimulant treatment. The authors discussed how the field could move from initial research mainly focused on serum ferritin towards a more comprehensive and translational investigation of iron in ADHD, with the potential to inform clinical practice in terms of screening and treating iron deficiency in individuals with ADHD.

Pilot Randomized Controlled Trial of Titrated Subcutaneous Ketamine in Older Patients with Treatment-Resistant Depression.

PubMed

George, Duncan; Gálvez, Verònica; Martin, Donel; Kumar, Divya; Leyden, John; Hadzi-Pavlovic, Dusan; Harper, Simon; Brodaty, Henry; Glue, Paul; Taylor, Rohan; Mitchell, Philip B; Loo, Colleen K

2017-11-01

To assess the efficacy and safety of subcutaneous ketamine for geriatric treatment-resistant depression. Secondary aims were to examine if repeated treatments were safe and more effective in inducing or prolonging remission than a single treatment. In this double-blind, controlled, multiple-crossover study with a 6-month follow-up (randomized controlled trial [RCT] phase), 16 participants (≥60 years) with treatment-resistant depression who relapsed after remission or did not remit in the RCT were administered an open-label phase. Up to five subcutaneous doses of ketamine (0.1, 0.2, 0.3, 0.4, and 0.5 mg/kg) were administered in separate sessions (≥1 week apart), with one active control (midazolam) randomly inserted (RCT phase). Twelve ketamine treatments were given in the open-label phase. Mood, hemodynamic, and psychotomimetic outcomes were assessed by blinded raters. Remitters in each phase were followed for 6 months. Seven of 14 RCT-phase completers remitted with ketamine treatment. Five remitted at doses below 0.5 mg/kg. Doses ≥ 0.2 mg/kg were significantly more effective than midazolam. Ketamine was well tolerated. Repeated treatments resulted in higher likelihood of remission or longer time to relapse. Results provide preliminary evidence for the efficacy and safety of ketamine in treating elderly depressed. Dose titration is recommended for optimizing antidepressant and safety outcomes on an individual basis. Subcutaneous injection is a practical method for giving ketamine. Repeated treatments may improve remission rates (clinicaltrials.gov; NCT01441505). Copyright © 2017 American Association for Geriatric Psychiatry. All rights reserved.

Sodium reduction in New Zealand requires major behaviour change.

PubMed

Lofthouse, Catherine; Te Morenga, Lisa; McLean, Rachael

2016-10-01

This pilot study examined the feasibility of adherence to a low sodium diet in a sample of healthy New Zealand adults. It also addressed whether following a low sodium diet was accompanied by changes in intakes of other nutrients that influence cardiovascular risk. Eleven healthy adults provided dietary intake data and a 24-hour urine collection at baseline and follow-up. They then received nutritional counselling based on the World Health Organization recommendation for sodium intake (<2000 mg/day) and received ongoing nutritional support while undertaking a low sodium diet for four weeks. At the end of the four-week period, participants completed a semi-structured interview that elicited participants' opinions on barriers and facilitators to following a low sodium diet and explored changes in participants' dietary habits and behaviours. Thematic analysis revealed that adherence to a low sodium diet required substantial changes to participants' usual food purchasing and preparation habits. Participants reported that lack of control over the sodium content of meals eaten away from the home, the complex and time-consuming nature of interpreting nutrition information labels, and difficulty identifying suitable snacks were barriers to adherence. Detailed meal planning and cooking from scratch, using flavour replacements, reading food labels to identify low sodium foods, receiving support from other people and receiving tailored nutrition advice were facilitators. Mean sodium intake reduced over the period, accompanied by a decrease in mean intake of total fat. These factors suggest that sodium reduction in New Zealand adults was feasible. However, considerable changes to eating behaviours were required. Copyright © 2016 Elsevier Ltd. All rights reserved.

The use of nutritional labels by college students in a food-court setting.

PubMed

Kolodinsky, Jane; Green, Jennifer; Michahelles, Marina; Harvey-Berino, Jean R

2008-01-01

Between January and September 2006, the authors examined when, why, if, and how nutrition labels impact food purchase decisions of college students. Participants were 16 college-aged students at a large northeastern university. As part of a larger study undertaken at a large northeastern university on the effect of nutrition labels in restaurant settings on food purchases, the authors held a focus group to look more deeply at when and why nutrition labeling impacted college student food purchases. Although results of the large study are still being discerned, the focus group results reveal that college women and men were interested in the provision of nutrition labels in the food court-like setting found at the university, and that those exposed to labels over the course of the study noticed these labels and often referred to them when making purchase decisions. Additional findings reveal that price and convenience also play a role in food purchases and that, of those items listed on each label, calories and fat were most important to the study population. Although more research is needed, this qualitative study finds that students want nutrition labels and would use them to make food purchasing decisions.

Improving FHWA's Ability to Assess Highway Infrastructure Health : Pilot Study Report

DOT National Transportation Integrated Search

2012-07-01

This report documents the results of a pilot study conducted as part of a project on improving FHWAs ability to assess highway infrastructure health. As part of the pilot study, a section of Interstate 90 through South Dakota, Minnesota, and Wisco...

Diagnostic labels of NANDA-I in a southern region of Spain

PubMed Central

González-Rodríguez, Rafael; Martelo-Baro, María de los Ángeles; Bas-Sarmiento, Pilar

2017-01-01

ABSTRACT Objective: to determine the incidence of NANDA-I diagnostic labels (North American Nursing Diagnosis Association-International) and to establish the distribution of cases of assistance and the associated labels, according to sociodemographic variables (age and sex). Method: descriptive, cross-sectional epidemiological study of labels of NANDA-I, under ecological design. The distribution of labels was analyzed according to sex and age; the corresponding frequencies were calculated and for each label the incidence were calculated rates with aggregate data from the attended cases. Results: the total number of cases of care under study was 9,928 (41.65% men and 58.35% women). The identified labels were 16,456 (7,084 men and 9,372 women); average of 1.7 labels per case of care; Out of 216 labels proposed by NANDA-I, in its 2012-14 classification, 152 were used, representing 70.4%. The labels with the highest incidence rates per thousand inhabitants were: Anxiety, Willingness to Improve Knowledge and Risk of Infection. Conclusions: the study allowed detecting, through NANDA-I, the answers to the health problems of greater incidence in the users attended. PMID:28614433

Recommendations for Planning Pilot Studies in Clinical and Translational Research

PubMed Central

Moore, Charity G.; Carter, Rickey E.; Nietert, Paul J.; Stewart, Paul W.

2011-01-01

Abstract  Advances in clinical and translation science are facilitated by building on prior knowledge gained through experimentation and observation. In the context of drug development, preclinical studies are followed by a progression of phase I through phase IV clinical trials. At each step, the study design and statistical strategies are framed around research questions that are prerequisites for the next phase. In other types of biomedical research, pilot studies are used for gathering preliminary support for the next research step. However, the phrase “pilot study” is liberally applied to projects with little or no funding, characteristic of studies with poorly developed research proposals, and usually conducted with no detailed thought of the subsequent study. In this article, we present a rigorous definition of a pilot study, offer recommendations for the design, analysis and sample size justification of pilot studies in clinical and translational research, and emphasize the important role that well‐designed pilot studies play in the advancement of science and scientific careers. Clin Trans Sci 2011; Volume 4: 332–337 PMID:22029804

Effect of nutrition labels on dietary quality among college students: a systematic review and meta-analysis.

PubMed

Christoph, Mary J; An, Ruopeng

2018-03-01

College students are at an elevated risk of poor nutrition and eating habits. The aim of this systematic review was to examine and quantify the effect of nutrition labels on diet quality in college students. Literature searches were conducted in 4 electronic databases. Peer-reviewed publications that assessed the effect of nutrition label use on food choice or dietary intake in college students were included. Twenty-two randomized controlled trials, cohort studies, and pre-post studies were identified. Sixteen studies found label exposure to be associated with improved diet. Of the 13 studies reporting calories selected or consumed, 8 found that posting labels at the point of purchase decreased calories, 4 found no effect, and 1 found that calories consumed increased after posting labels. Nine of the 12 studies assessing noncaloric measures found that nutrition labels positively affected diet quality. Meta-analysis of pre-post studies found a decrease of 36 kcal (P < 0.05) with label exposure. Nutrition labels had a moderate but positive effect on dietary intake of college students. © The Author(s) 2018. Published by Oxford University Press on behalf of the International Life Sciences Institute. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Piloted simulation study of an ILS approach of a twin-pusher business/commuter turboprop aircraft configuration

NASA Technical Reports Server (NTRS)

Riley, Donald R.; Brandon, Jay M.; Glaab, Louis J.

1994-01-01

A six-degree-of-freedom nonlinear simulation of a twin-pusher, turboprop business/commuter aircraft configuration representative of the Cessna ATPTB (Advanced turboprop test bed) was developed for use in piloted studies with the Langley General Aviation Simulator. The math models developed are provided, simulation predictions are compared with with Cessna flight-test data for validation purposes, and results of a handling quality study during simulated ILS (instrument landing system) approaches and missed approaches are presented. Simulated flight trajectories, task performance measures, and pilot evaluations are presented for the ILS approach and missed-approach tasks conducted with the vehicle in the presence of moderate turbulence, varying horizontal winds and engine-out conditions. Six test subjects consisting of two research pilots, a Cessna test pilot, and three general aviation pilots participated in the study. This effort was undertaken in cooperation with the Cessna Aircraft Company.

Study to determine the IFR operational profile and problems to the general aviation pilot

NASA Technical Reports Server (NTRS)

Weislogel, S.

1983-01-01

A study of the general aviation single pilot operating under instrument flight rules (GA SPIFR) has been conducted for NASA Langley Research Center. The objectives of the study were to (1) develop a GA SPIFR operational profile, (2) identify problems experienced by the GA SPIFR pilot, and (3) identify research tasks which have the potential for eliminating or reducing the severity of the problems. To obtain the information necessary to accomplish these objectives, a mail questionnaire survey of instrument rated pilots was conducted. Complete questionnaire data is reported in NASA CR-165805, "Statistical Summary: Study to Determine the IFR Operational Profile and Problems of the General Aviation Single Pilot'-Based upon the results of the GA SPIFR survey, this final report presents the general aviation IFR single pilot operational profile, illustrates selected data analysis, examples, identifies the problems which he is experiencing, and recommends further research.

Calorie menu labeling on quick-service restaurant menus: an updated systematic review of the literature.

PubMed

Swartz, Jonas J; Braxton, Danielle; Viera, Anthony J

2011-12-08

Nutrition labels are one strategy being used to combat the increasing prevalence of overweight and obesity in the United States. The Patient Protection and Affordable Care Act of 2010 mandates that calorie labels be added to menu boards of chain restaurants with 20 or more locations. This systematic review includes seven studies published since the last review on the topic in 2008. Authors searched for peer-reviewed studies using PUBMED and Google Scholar. Included studies used an experimental or quasi-experimental design comparing a calorie-labeled menu with a no-calorie menu and were conducted in laboratories, college cafeterias, and fast food restaurants. Two of the included studies were judged to be of good quality, and five of were judged to be of fair quality. Observational studies conducted in cities after implementation of calorie labeling were imprecise in their measure of the isolated effects of calorie labels. Experimental studies conducted in laboratory settings were difficult to generalize to real world behavior. Only two of the seven studies reported a statistically significant reduction in calories purchased among consumers using calorie-labeled menus. The current evidence suggests that calorie labeling does not have the intended effect of decreasing calorie purchasing or consumption.

Systematic Comparison of Label-Free, Metabolic Labeling, and Isobaric Chemical Labeling for Quantitative Proteomics on LTQ Orbitrap Velos

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

Li, Zhou; Adams, Rachel M; Chourey, Karuna

2012-01-01

A variety of quantitative proteomics methods have been developed, including label-free, metabolic labeling, and isobaric chemical labeling using iTRAQ or TMT. Here, these methods were compared in terms of the depth of proteome coverage, quantification accuracy, precision, and reproducibility using a high-performance hybrid mass spectrometer, LTQ Orbitrap Velos. Our results show that (1) the spectral counting method provides the deepest proteome coverage for identification, but its quantification performance is worse than labeling-based approaches, especially the quantification reproducibility; (2) metabolic labeling and isobaric chemical labeling are capable of accurate, precise, and reproducible quantification and provide deep proteome coverage for quantification. Isobaricmore » chemical labeling surpasses metabolic labeling in terms of quantification precision and reproducibility; (3) iTRAQ and TMT perform similarly in all aspects compared in the current study using a CID-HCD dual scan configuration. Based on the unique advantages of each method, we provide guidance for selection of the appropriate method for a quantitative proteomics study.« less

The science on front-of-package food labels.

PubMed

Hawley, Kristy L; Roberto, Christina A; Bragg, Marie A; Liu, Peggy J; Schwartz, Marlene B; Brownell, Kelly D

2013-03-01

The U.S. Food and Drug Administration and Institute of Medicine are currently investigating front-of-package (FOP) food labelling systems to provide science-based guidance to the food industry. The present paper reviews the literature on FOP labelling and supermarket shelf-labelling systems published or under review by February 2011 to inform current investigations and identify areas of future research. A structured search was undertaken of research studies on consumer use, understanding of, preference for, perception of and behaviours relating to FOP/shelf labelling published between January 2004 and February 2011. Twenty-eight studies from a structured search met inclusion criteria. Reviewed studies examined consumer preferences, understanding and use of different labelling systems as well as label impact on purchasing patterns and industry product reformulation. The findings indicate that the Multiple Traffic Light system has most consistently helped consumers identify healthier products; however, additional research on different labelling systems' abilities to influence consumer behaviour is needed.

Reflecting on the Germanwings Disaster: A Systematic Review of Depression and Suicide in Commercial Airline Pilots.

PubMed

Pasha, Terouz; Stokes, Paul R A

2018-01-01

The 2015 Germanwings Flight 9525 disaster, in which 150 people were killed after the co-pilot may have intentionally crashed the plane in a suicide attempt, highlights the importance of better understanding the mental health of commercial airline pilots. However, there have been few systematic reviews investigating the topic of mental health in commercial aviation. This systematic review aims to identify the types and prevalence of mental health disorders that commercial airline pilots experience with a focus on mood disorders and suicide risk. A systematic literature search was performed using PubMed, EMBASE, and PsycINFO databases. Eligible studies were assessed and data was extracted and analyzed. 20 studies were identified. The prevalence of depression experienced by commercial airline pilots in this review ranged from 1.9% to 12.6%. Factors that negatively impacted the mental health of pilots included substance abuse, experiencing verbal or sexual abuse, disruption in sleep circadian rhythms and fatigue. This systematic review identifies that commercial airline pilots may experience depression at least as frequently as the general population. Commercial airline pilots experience occupational stressors, such as disrupted circadian rhythms and fatigue which may increase risks of developing mood disorders. Most studies identified in this review were cross-sectional in nature with substantial limitations. There is a clear need for further higher quality longitudinal studies to better understand the mental health of commercial airline pilots.

A study on aircraft map display location and orientation. [effects of map display location on manual piloting performance

NASA Technical Reports Server (NTRS)

Baty, D. L.; Wempe, T. E.; Huff, E. M.

1973-01-01

Six airline pilots participated in a fixed-base simulator study to determine the effects of two Horizontal Situation Display (HSD/map) panel locations relative to the Vertical Situation Display (VSD), and of three map orientations on manual piloting performance. Pilot comments and opinions were formally obtained. Significant performance differences were found between wind conditions, and among pilots, but not between map locations and orientations. The results also illustrate the potential tracking accuracy of such a display. Recommendations concerning display location and map orientation are made.

78 FR 48715 - Proposed Information Collection; Comment Request: NPS Study of Value of Natural Sounds: A Pilot...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-09

....NS0000] Proposed Information Collection; Comment Request: NPS Study of Value of Natural Sounds: A Pilot Study AGENCY: National Park Service, Interior. ACTION: Notice; request for comments. SUMMARY: We.... This is a new collection. Title: NPS Study of Value of Natural Sounds: A Pilot Study. Type of Request...

Prediction of aircraft handling qualities using analytical models of the human pilot

NASA Technical Reports Server (NTRS)

Hess, R. A.

1982-01-01

The optimal control model (OCM) of the human pilot is applied to the study of aircraft handling qualities. Attention is focused primarily on longitudinal tasks. The modeling technique differs from previous applications of the OCM in that considerable effort is expended in simplifying the pilot/vehicle analysis. After briefly reviewing the OCM, a technique for modeling the pilot controlling higher order systems is introduced. Following this, a simple criterion for determining the susceptibility of an aircraft to pilot-induced oscillations (PIO) is formulated. Finally, a model-based metric for pilot rating prediction is discussed. The resulting modeling procedure provides a relatively simple, yet unified approach to the study of a variety of handling qualities problems.

Prediction of aircraft handling qualities using analytical models of the human pilot

NASA Technical Reports Server (NTRS)

Hess, R. A.

1982-01-01

The optimal control model (OCM) of the human pilot is applied to the study of aircraft handling qualities. Attention is focused primarily on longitudinal tasks. The modeling technique differs from previous applications of the OCM in that considerable effort is expended in simplifying the pilot/vehicle analysis. After briefly reviewing the OCM, a technique for modeling the pilot controlling higher order systems is introduced. Following this, a simple criterion for determining the susceptibility of an aircraft to pilot induced oscillations is formulated. Finally, a model based metric for pilot rating prediction is discussed. The resulting modeling procedure provides a relatively simple, yet unified approach to the study of a variety of handling qualities problems.

An analytical approach for predicting pilot induced oscillations

NASA Technical Reports Server (NTRS)

Hess, R. A.

1981-01-01

The optimal control model (OCM) of the human pilot is applied to the study of aircraft handling qualities. Attention is focused primarily on longitudinal tasks. The modeling technique differs from previous applications of the OCM in that considerable effort is expended in simplifying the pilot/vehicle analysis. After briefly reviewing the OCM, a technique for modeling the pilot controlling higher order systems is introduced. Following this, a simple criterion or determining the susceptability of an aircraft to pilot induced oscillations (PIO) is formulated. Finally, a model-based metric for pilot rating prediction is discussed. The resulting modeling procedure provides a relatively simple, yet unified approach to the study of a variety of handling qualities problems.

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.

Enhancing masculinity by slandering homosexuals: the role of homophobic epithets in heterosexual gender identity.

PubMed

Carnaghi, Andrea; Maass, Anne; Fasoli, Fabio

2011-12-01

The current studies investigate the effects of homophobic labels on the self-perception of heterosexual males, hypothesizing that when exposed to homophobic epithets, they are motivated to underline their masculinity and claim a distinctly heterosexual identity by taking distance from homosexuals and, to a lesser degree, from women. Heterosexual male participants were subliminally (Study 1) and supraliminally (Study 2) primed either by a homophobic epithet or by a category label, and completed the Traditional Beliefs About Gender and Gender Identity scale. Participants stressed their heterosexual identity, but not their gender distinctiveness, when exposed to homophobic epithets, compared to category labels. Study 2 demonstrated that the relation between the homophobic label and the participants' heterosexual identity was mediated by how negatively they reacted to the antigay label. Heterosexual identity was enhanced in reaction to homophobic labels but not to an equally derogatory label referring to regional identity. Results are discussed within an intergroup framework.

Pilot age and error in air taxi crashes.

PubMed

Rebok, George W; Qiang, Yandong; Baker, Susan P; Li, Guohua

2009-07-01

The associations of pilot error with the type of flight operations and basic weather conditions are well documented. The correlation between pilot characteristics and error is less clear. This study aims to examine whether pilot age is associated with the prevalence and patterns of pilot error in air taxi crashes. Investigation reports from the National Transportation Safety Board for crashes involving non-scheduled Part 135 operations (i.e., air taxis) in the United States between 1983 and 2002 were reviewed to identify pilot error and other contributing factors. Crash circumstances and the presence and type of pilot error were analyzed in relation to pilot age using Chi-square tests. Of the 1751 air taxi crashes studied, 28% resulted from mechanical failure, 25% from loss of control at landing or takeoff, 7% from visual flight rule conditions into instrument meteorological conditions, 7% from fuel starvation, 5% from taxiing, and 28% from other causes. Crashes among older pilots were more likely to occur during the daytime rather than at night and off airport than on airport. The patterns of pilot error in air taxi crashes were similar across age groups. Of the errors identified, 27% were flawed decisions, 26% were inattentiveness, 23% mishandled aircraft kinetics, 15% mishandled wind and/or runway conditions, and 11% were others. Pilot age is associated with crash circumstances but not with the prevalence and patterns of pilot error in air taxi crashes. Lack of age-related differences in pilot error may be attributable to the "safe worker effect."

75 FR 80827 - Compliance Policy Guide; Radiofrequency Identification Feasibility Studies and Pilot Programs for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-23

... Identification (RFID) Feasibility Studies and Pilot Programs for Drugs'' to December 31, 2012. FOR FURTHER... Sec. 400.210 entitled ``Radiofrequency Identification (RFID) Feasibility Studies and Pilot Programs... FR 65750, November 23, 2007; 73 FR 78371, December 22, 2008). FDA has identified RFID as a promising...

Autogenic-feedback training improves pilot performance during emergency flying conditions

NASA Technical Reports Server (NTRS)

Kellar, Michael A.; Folen, Raymond A.; Cowings, Patricia S.; Toscano, William B.; Hisert, Glen L.

1994-01-01

Studies have shown that autonomous mode behavior is one cause of aircraft fatalities due to pilot error. In such cases, the pilot is in a high state of psychological and physiological arousal and tends to focus on one problem, while ignoring more critical information. This study examined the effect of training in physiological self-recognition and regulation, as a means of improving crew cockpit performance. Seventeen pilots were assigned to the treatment and control groups matched for accumulated flight hours. The treatment group comprised three pilots of HC-130 Hercules aircraft and four HH-65 Dolphin helicopter pilots; the control group comprised three pilots of HC-130's and six Dolphin helicopter pilots. During an initial flight, physiological data were recorded for each crew member and individual crew performance was rated by an instructor pilot. Eight crewmembers were then taught to regulate their own physiological response levels using Autogenic-Feedback Training (AFT). The remaining subjects received no training. During a second flight, treatment subjects showed significant improvement in performance, while controls did not improve. The results indicate that AFT management of high states of physiological arousal may improve pilot performance during emergency flying conditions.

Challenges of the pharmacological management of benzodiazepine withdrawal, dependence, and discontinuation

PubMed Central

Revadigar, Neelambika; Manobianco, Brittany E.

2018-01-01

Background: Benzodiazepines (BZDs) are among the most prescribed sedative hypnotics and among the most misused and abused medications by patients, in parallel with opioids. It is estimated that more than 100 million Benzodiazepine (BZD) prescriptions were written in the United States in 2009. While medically useful, BZDs are potentially dangerous. The co-occurring abuse of opioids and BZD, as well as increases in BZD abuse, tolerance, dependence, and short- and long-term side effects, have prompted a worldwide discussion about the challenging aspects of medically managing the discontinuation of BZDs. Abrupt cessation can cause death. This paper addresses the challenges of medications suggested for the management of BZD discontinuation, their efficacy, the risks of abuse and associated medical complications. The focus of this review is on the challenges of several medications suggested for the management of BZD discontinuation, their efficacy, the risks of abuse, and associated medical complications. Methods: An electronic search was performed of Medline, Worldwide Science, Directory of Open Access Journals, Embase, Cochrane Library, Google Scholar, PubMed Central, and PubMed from 1990 to 2017. The review includes double-blind, placebo-controlled studies for the most part, open-label pilot studies, and animal studies, in addition to observational research. We expand the search to review articles, naturalistic studies, and to a lesser extent, letters to the editor/case reports. We exclude abstract and poster presentations, books, and book chapters. Results: The efficacy of these medications is not robust. While some of these medicines are relatively safe to use, some of them have a narrow therapeutic index, with severe, life-threatening side effects. Randomized studies have been limited. There is a paucity of comparative research. The review has several limitations. The quality of the documents varies according to whether they are randomized studies, nonrandomized studies, naturalistic studies, pilot studies, letters to the editors, or case reports. Conclusions: The use of medications for the discontinuation of BZDs seems appropriate. It is a challenge that requires further investigation through randomized clinical trials to maximize efficacy and to minimize additional risks and side effects. PMID:29713452

Challenges of the pharmacological management of benzodiazepine withdrawal, dependence, and discontinuation.

PubMed

Fluyau, Dimy; Revadigar, Neelambika; Manobianco, Brittany E

2018-05-01

Benzodiazepines (BZDs) are among the most prescribed sedative hypnotics and among the most misused and abused medications by patients, in parallel with opioids. It is estimated that more than 100 million Benzodiazepine (BZD) prescriptions were written in the United States in 2009. While medically useful, BZDs are potentially dangerous. The co-occurring abuse of opioids and BZD, as well as increases in BZD abuse, tolerance, dependence, and short- and long-term side effects, have prompted a worldwide discussion about the challenging aspects of medically managing the discontinuation of BZDs. Abrupt cessation can cause death. This paper addresses the challenges of medications suggested for the management of BZD discontinuation, their efficacy, the risks of abuse and associated medical complications. The focus of this review is on the challenges of several medications suggested for the management of BZD discontinuation, their efficacy, the risks of abuse, and associated medical complications. An electronic search was performed of Medline, Worldwide Science, Directory of Open Access Journals, Embase, Cochrane Library, Google Scholar, PubMed Central, and PubMed from 1990 to 2017. The review includes double-blind, placebo-controlled studies for the most part, open-label pilot studies, and animal studies, in addition to observational research. We expand the search to review articles, naturalistic studies, and to a lesser extent, letters to the editor/case reports. We exclude abstract and poster presentations, books, and book chapters. The efficacy of these medications is not robust. While some of these medicines are relatively safe to use, some of them have a narrow therapeutic index, with severe, life-threatening side effects. Randomized studies have been limited. There is a paucity of comparative research. The review has several limitations. The quality of the documents varies according to whether they are randomized studies, nonrandomized studies, naturalistic studies, pilot studies, letters to the editors, or case reports. The use of medications for the discontinuation of BZDs seems appropriate. It is a challenge that requires further investigation through randomized clinical trials to maximize efficacy and to minimize additional risks and side effects.

Using Motivational Enhancement Among OIF / OEF Veterans Returning to the Community

DTIC Science & Technology

2014-10-01

than veterans who receive treatment as usual. During this year the pilot study for the project was completed. The purpose of the pilot study group was...pilot group members could not be used. The veterans in the pilot study were notified of the lapse and were re-consented. During the year the team...Veterans must not be currently in counseling to participate in the project. To combat this, one idea proposed is to allow veterans who live outside of

Compensation for time delay in flight simulator visual-display systems

NASA Technical Reports Server (NTRS)

Crane, D. F.

1983-01-01

A piloted aircraft can be viewed as a closed-loop, man-machine control system. When a simulator pilot is performing a precision maneuver, a delay in the visual display of aircraft response to pilot-control input decreases the stability of the pilot-aircraft system. The less stable system is more difficult to control precisely. Pilot dynamic response and performance change as the pilot attempts to compensate for the decrease in system stability, and these changes bias the simulation results by influencing the pilot's rating of the handling qualities of the simulated aircraft. Delay compensation, designed to restore pilot-aircraft system stability, was evaluated in several studies which are reported here. The studies range from single-axis, tracking-task experiments (with sufficient subjects and trials to establish statistical significance of the results) to a brief evaluation of compensation of a computer-generated-imagery (CGI) visual display system in a full six-degree-of-freedom simulation. The compensation was effective - improvements in pilot performance and workload or aircraft handling-qualities rating (HQR) were observed. Results from recent aircraft handling-qualities research literature which support the compensation design approach are also reviewed.

Production of isotopically labeled standards from a uniformly labeled precursor for quantitative volatile metabolomic studies.

PubMed

Gómez-Cortés, Pilar; Brenna, J Thomas; Sacks, Gavin L

2012-06-19

Optimal accuracy and precision in small-molecule profiling by mass spectrometry generally requires isotopically labeled standards chemically representative of all compounds of interest. However, preparation of mixed standards from commercially available pure compounds is often prohibitively expensive and time-consuming, and many labeled compounds are not available in pure form. We used a single-prototype uniformly labeled [U-(13)C]compound to generate [U-(13)C]-labeled volatile standards for use in subsequent experimental profiling studies. [U-(13)C]-α-Linolenic acid (18:3n-3, ALA) was thermally oxidized to produce labeled lipid degradation volatiles which were subsequently characterized qualitatively and quantitatively. Twenty-five [U-(13)C]-labeled volatiles were identified by headspace solid-phase microextraction-gas chromatography/time-of-flight mass spectrometry (HS-SPME-GC/TOF-MS) by comparison of spectra with unlabeled volatiles. Labeled volatiles were quantified by a reverse isotope dilution procedure. Using the [U-(13)C]-labeled standards, limits of detection comparable to or better than those of previous HS-SPME reports were achieved, 0.010-1.04 ng/g. The performance of the [U-(13)C]-labeled volatile standards was evaluated using a commodity soybean oil (CSO) oxidized at 60 °C from 0 to 15 d. Relative responses of n-decane, an unlabeled internal standard otherwise absent from the mixture, and [U-(13)C]-labeled oxidation products changed by up to 8-fold as the CSO matrix was oxidized, demonstrating that reliance on a single standard in volatile profiling studies yields inaccurate results due to changing matrix effects. The [U-(13)C]-labeled standard mixture was used to quantify 25 volatiles in oxidized CSO and low-ALA soybean oil with an average relative standard deviation of 8.5%. Extension of this approach to other labeled substrates, e.g., [U-(13)C]-labeled sugars and amino acids, for profiling studies should be feasible and can dramatically improve quantitative results compared to use of a single standard.

Repurposing a Histamine Detection Platform for High-Throughput Screening of Histidine Decarboxylase.

PubMed

Juang, Yu-Chi; Fradera, Xavier; Han, Yongxin; Partridge, Anthony William

2018-06-01

Histidine decarboxylase (HDC) is the primary enzyme that catalyzes the conversion of histidine to histamine. HDC contributes to many physiological responses as histamine plays important roles in allergic reaction, neurological response, gastric acid secretion, and cell proliferation and differentiation. Small-molecule modulation of HDC represents a potential therapeutic strategy for a range of histamine-associated diseases, including inflammatory disease, neurological disorders, gastric ulcers, and select cancers. High-throughput screening (HTS) methods for measuring HDC activity are currently limited. Here, we report the development of a time-resolved fluorescence resonance energy transfer (TR-FRET) assay for monitoring HDC activity. The assay is based on competition between HDC-generated histamine and fluorophore-labeled histamine for binding to a Europium cryptate (EuK)-labeled anti-histamine antibody. We demonstrated that the assay is highly sensitive and simple to develop. Assay validation experiments were performed using low-volume 384-well plates and resulted in good statistical parameters. A pilot HTS screen gave a Z' score > 0.5 and a hit rate of 1.1%, and led to the identification of a validated hit series. Overall, the presented assay should facilitate the discovery of therapeutic HDC inhibitors by acting as a novel tool suitable for large-scale HTS and subsequent interrogation of compound structure-activity relationships.

Experience with the use of the Codonics Safe Label System(™) to improve labelling compliance of anaesthesia drugs.

PubMed

Ang, S B L; Hing, W C; Tung, S Y; Park, T

2014-07-01

The Codonics Safe Labeling System(™) (http://www.codonics.com/Products/SLS/flash/) is a piece of equipment that is able to barcode scan medications, read aloud the medication and the concentration and print a label of the appropriate concentration in the appropriate colour code. We decided to test this system in our facility to identify risks, benefits and usability. Our project comprised a baseline survey (25 anaesthesia cases during which 212 syringes were prepared from 223 drugs), an observational study (47 cases with 330 syringes prepared) and a user acceptability survey. The baseline compliance with all labelling requirements was 58%. In the observational study the compliance using the Codonics system was 98.6% versus 63.8% with conventional labelling. In the user acceptability survey the majority agreed the Codonics machine was easy to use, more legible and adhered with better security than the conventional preprinted label. However, most were neutral when asked about the likelihood of flexibility and customisation and were dissatisfied with the increased workload. Our findings suggest that the Codonics labelling machine is user-friendly and it improved syringe labelling compliance in our study. However, staff need to be willing to follow proper labelling workflow rather than batch label during preparation. Future syringe labelling equipment developers need to concentrate on user interface issues to reduce human factor and workflow problems. Support logistics are also an important consideration prior to implementation of any new labelling system.

A systematic review of calorie labeling and modified calorie labeling interventions: Impact on consumer and restaurant behavior

PubMed Central

Bleich, Sara N.; Economos, Christina D.; Spiker, Marie L.; Vercammen, Kelsey; VanEpps, Eric M.; Block, Jason P.; Elbel, Brian; Story, Mary; Roberto, Christina A.

2017-01-01

Background Evidence on the effects of restaurant calorie labeling on consumer and restaurant behavior is mixed. This paper examined: 1) consumer responses to calorie information alone or compared to modified calorie information, and 2) changes in restaurant offerings following or in advance of menu labeling implementation. Methods We searched PubMed, Web of Science, Policy File and PAIS International to identify restaurant calorie labeling studies through October 1, 2016, that measured calories ordered, consumed, or available for purchase on restaurant menus. We also searched reference lists of calorie labeling articles. Results Fifty-three studies were included: 18 in real-world restaurants, 9 in cafeterias, and 21 in laboratory or simulation settings. Five examined restaurant offerings. Conclusion Due to a lack of well-powered studies with strong designs, the degree to which menu labeling encourages lower calorie purchases and whether that translates to a healthier population is unclear. Although there is limited evidence that menu labeling affects calories purchased at fast-food restaurants, some evidence demonstrates that it lowers calories purchased at certain types of restaurants and in cafeteria settings. The limited data on modified calorie labels find that such labels can encourage lower-calorie purchases, but may not differ in effects relative to calorie labels alone. PMID:29045080

A Systematic Review of Calorie Labeling and Modified Calorie Labeling Interventions: Impact on Consumer and Restaurant Behavior.

PubMed

Bleich, Sara N; Economos, Christina D; Spiker, Marie L; Vercammen, Kelsey A; VanEpps, Eric M; Block, Jason P; Elbel, Brian; Story, Mary; Roberto, Christina A

2017-12-01

Evidence on the effects of restaurant calorie labeling on consumer and restaurant behavior is mixed. This paper examined: (1) consumer responses to calorie information alone or compared to modified calorie information and (2) changes in restaurant offerings following or in advance of menu labeling implementation. Searches were conducted in PubMed, Web of Science, Policy File, and PAIS International to identify restaurant calorie labeling studies through October 1, 2016, that measured calories ordered, consumed, or available for purchase on restaurant menus. The reference lists of calorie labeling articles were also searched. Fifty-three studies were included: 18 in real-world restaurants, 9 in cafeterias, and 21 in laboratory or simulation settings. Five examined restaurant offerings. Because of a lack of well-powered studies with strong designs, the degree to which menu labeling encourages lower-calorie purchases and whether that translates to a healthier population are unclear. Although there is limited evidence that menu labeling affects calories purchased at fast-food restaurants, some evidence demonstrates that it lowers calories purchased at certain types of restaurants and in cafeteria settings. The limited data on modified calorie labels find that such labels can encourage lower-calorie purchases but may not differ in effects relative to calorie labels alone. © 2017 The Obesity Society.

NORTHWEST ORGEON PILOT STUDY AREA (USA): THE USE OF LANDSCAPE SCIENCE FOR ENVIRONMENTAL ASSESSMENT PILOT STUDY

EPA Science Inventory

The Northwest Oregon Pilot Study Area encompasses approximately 59,167 km2 and varies in elevation from sea level to 3,200 m. Annual precipitation varies with elevation and meridian and ranges from 25 - 460cm. The study area comprises a mixture of federal, state, and privately ow...

Energy and traffic light labelling have no impact on parent and child fast food selection.

PubMed

Dodds, Pennie; Wolfenden, Luke; Chapman, Kathy; Wellard, Lyndal; Hughes, Clare; Wiggers, John

2013-10-25

Labelling of food from fast food restaurants at point-of-purchase has been suggested as one strategy to reduce population energy consumption and contribute to reductions in obesity prevalence. The aim of this study was to examine the effects of energy and single traffic light labelling systems on the energy content of child and adult intended food purchases. The study employed a randomised controlled trial design. English speaking parents of children aged between three and 12 years were recruited from an existing research cohort. Participants were mailed one of three hypothetical fast food menus. Menus differed in their labelling technique- either energy labels, single traffic light labels, or a no-label control. Participants then completed a telephone survey which assessed intended food purchases for both adult and child. The primary trial outcome was total energy of intended food purchase. A total of 329 participants completed the follow-up telephone interview. Eighty-two percent of the energy labelling group and 96% of the single traffic light labelling group reported noticing labelling information on their menu. There were no significant differences in total energy of intended purchases of parents, or intended purchases made by parents for children, between the menu labelling groups, or between menu labelling groups by socio-demographic subgroups. This study provided no evidence to suggest that energy labelling or single traffic light labelling alone were effective in reducing the energy of fast food items selected from hypothetical fast food menus for purchase. Additional complementary public health initiatives promoting the consumption of healthier foods identified by labelling, and which target other key drivers of menu item selection in this setting may be required. Copyright © 2013. Published by Elsevier Ltd.

The effect of energy and traffic light labelling on parent and child fast food selection: a randomised controlled trial.

PubMed

Dodds, Pennie; Wolfenden, Luke; Chapman, Kathy; Wellard, Lyndal; Hughes, Clare; Wiggers, John

2014-02-01

Labelling of food from fast food restaurants at point-of-purchase has been suggested as one strategy to reduce population energy consumption and contribute to reductions in obesity prevalence. The aim of this study was to examine the effects of energy and single traffic light labelling systems on the energy content of child and adult intended food purchases. The study employed a randomised controlled trial design. English speaking parents of children aged between three and 12 years were recruited from an existing research cohort. Participants were mailed one of three hypothetical fast food menus. Menus differed in their labelling technique – either energy labels, single traffic light labels, or a no-label control. Participants then completed a telephone survey which assessed intended food purchases for both adult and child. The primary trial outcome was total energy of intended food purchase. A total of 329 participants completed the follow-up telephone interview. Eighty-two percent of the energy labelling group and 96% of the single traffic light labelling group reported noticing labelling information on their menu. There were no significant differences in total energy of intended purchases of parents, or intended purchases made by parents for children, between the menu labelling groups, or between menu labelling groups by socio-demographic subgroups. This study provided no evidence to suggest that energy labelling or single traffic light labelling alone were effective in reducing the energy of fast food items selected from hypothetical fast food menus for purchase. Additional complementary public health initiatives promoting the consumption of healthier foods identified by labelling, and which target other key drivers of menu item selection in this setting may be required.

The impact of nutritional labels and socioeconomic status on energy intake. An experimental field study.

PubMed

Crockett, Rachel A; Jebb, Susan A; Hankins, Matthew; Marteau, Theresa M

2014-10-01

There is some evidence for paradoxical effects of nutritional labelling on energy intake particularly amongst restrained eaters and those with a higher body mass index (BMI) resulting in greater consumption of energy from foods with a positive health message (e.g. "low-fat") compared with the same foods, unlabelled. This study aimed to investigate, in a UK general population sample, the likelihood of paradoxical effects of nutritional labelling on energy intake. Participants (n = 287) attended a London cinema and were offered a large tub of salted or toffee popcorn. Participants were randomised to receive their selected flavour with one of three labels: a green low-fat label, a red high-fat label or no label. Participants watched two film clips while completing measures of demographic characteristics, emotional state and taste of the popcorn. Following the experiment, popcorn consumption was measured. There were no main effects of nutritional labelling on consumption. Contrary to predictions neither BMI nor weight concern moderated the effect of label on consumption. There was a three-way interaction between low-fat label, weight concern and socioeconomic status (SES) such that weight-concerned participants of higher SES who saw a low-fat label consumed more than weight unconcerned participants of similar SES (t = -2.7, P = .04). By contrast, weight-concerned participants of lower SES seeing either type of label, consumed less than those seeing no label (t = -2.04, P = .04). Nutritional labelling may have different effects in different socioeconomic groups. Further studies are required to understand fully the possible contribution of food labelling to health inequalities. Copyright © 2014 Elsevier Ltd. All rights reserved.

Pilot Comments From the Boeing High Speed Research Aircraft, Cycle 3, Simulation Study of the Effects of Aeroservoelasticity (LaRC.3)

NASA Technical Reports Server (NTRS)

Bailey, Melvin L. (Editor)

2000-01-01

This is a compilation of pilot comments from the Boeing High Speed Research Aircraft, Cycle 3, simulation study (LaRC.3) of the effects of aeroservoelasticity, conducted from October to December 1997 at NASA Langley Research Center. This simulation study was conducted using the Visual Motion Simulator. The comments are from direct tape transcriptions and have been edited for spelling only. These comments were made on tape following the completion of each flight card, immediately after the pilot was satisfied with his practice and data recording runs. Six pilots were used in the evaluation and they are identified as pilots A through F.

The use of total simulator training in transitioning air-carrier pilots: A field evaluation

NASA Technical Reports Server (NTRS)

Randle, R. J., Jr.; Tanner, T. A.; Hamerman, J. A.; Showalter, T. H.

1981-01-01

A field study was conducted in which the performance of air carrier transitioning pilots who had landing training in a landing maneuver approved simulator was compared with the performance of pilots who had landing training in the aircraft. Forty-eight trainees transitioning to the B-727 aircraft and eighty-seven trainees transitioning to the DC-10 were included in the study. The study results in terms of both objectively measured performance indicants and observer and check-pilot ratings did not demonstrate a clear distinction between the two training groups. The results suggest that, for these highly skilled transitioning pilots, a separate training module in the aircraft may be of dubious value.

Evaluation of adverse drug event information in US manufacturer labels.

PubMed

Harrington, Catherine A; Garcia, Angela S; Sircar-Ramsewak, Feroza

2011-02-01

Pharmaceutical manufacturer labels are an important source of adverse drug event (ADE) information. The study objective was to determine the sufficiency of ADE reporting in US drug labels. A sample of 50 labels was evaluated from the top 200 drugs dispensed in the US. Electronic copies of labels were obtained and reviewed by 2 pharmacists for ADE incidence and discontinuation data. ADE incidence data were provided in 86% of labels. However, discontinuation rates due to ADEs and ADE incidence by dose were only reported in 60%. ADE incidence reporting by age (46%) or gender (18%) was also low. ADEs that occurred in less than 2% of the population were rarely reported. Incidence rates were based on small populations (median of 794) and short term studies (median of 84 days for chronic conditions). Labels for 19 drugs used chronically had no long term study data. Methods for collecting ADE data were stated in only 12% of labels. Adverse drug event and drug discontinuation data is under-reported in US labels. More information on adverse events causing discontinuation (especially serious events) and those related to dose, age, and gender is needed in labels to ensure safe prescribing and dispensing of drugs.

Graphic warnings and text warning labels on cigarette packages in Riyadh Kingdom of Saudi Arabia: Awareness and perceptions

PubMed Central

Jradi, Hoda; Saddik, Basema

2018-01-01

BACKGROUND: Graphic warning labels have been shown to be effective in smoking initiation and cessation and were implemented in Saudi Arabia in 2012. To date, no study has assessed the effectiveness of these labels and the Saudi population's perceptions on the effectiveness of cigarette health warning labels. METHODS: We used a cross-sectional qualitative study comprising of nine focus groups among 3 different community group members including health-care workers, adult women and adult men. We conducted in-depth interviews among community leaders. Both focus groups and interviews assessed awareness levels and elicited perceptions about health warning labels on cigarette boxes currently used in the Kingdom of Saudi Arabia. RESULTS: While most participants in the study were aware and supported the use of graphic warning labels on cigarette packages, the awareness of the specific details on the labels was low. Participants perceived the effectiveness of current labels somewhat vague in smoking cessation and advocated for stronger and more aggressive graphics. Community leaders, however, preferred text-only labels and did not support aggressive labels which were deemed culturally and religiously inappropriate. CONCLUSIONS: The study suggests that while graphic warning labels are perceived as necessary on cigarette packages the currently used messages are not clear and therefore do not serve their intended purposes. Measures should be undertaken to ensure that pictorial cigarette labels used in Saudi Arabia are culturally and ethnically appropriate and are rotated on a regular basis to ensure salience among smokers and nonsmokers alike. PMID:29387252

An Investigation of Feasibility and Safety of Bi-Modal Stimulation for the Treatment of Tinnitus: An Open-Label Pilot Study.

PubMed

Hamilton, Caroline; D'Arcy, Shona; Pearlmutter, Barak A; Crispino, Gloria; Lalor, Edmund C; Conlon, Brendan J

2016-12-01

Tinnitus is the perception of sound in the absence of an external auditory stimulus. It is widely believed that tinnitus, in patients with associated hearing loss, is a neurological phenomenon primarily affecting the central auditory structures. However, there is growing evidence for the involvement of the somatosensory system in this form of tinnitus. For this reason it has been suggested that the condition may be amenable to bi-modal stimulation of the auditory and somatosensory systems. We conducted a pilot study to investigate the feasibility and safety of a device that delivers simultaneous auditory and somatosensory stimulation to treat the symptoms of chronic tinnitus. A cohort of 54 patients used the stimulation device for 10 weeks. Auditory stimulation was delivered via headphones and somatosensory stimulation was delivered via electrical stimulation of the tongue. Patient usage, logged by the device, was used to classify patients as compliant or noncompliant. Safety was assessed by reported adverse events and changes in tinnitus outcome measures. Response to treatment was assessed using tinnitus outcome measures: Minimum Masking Level (MML), Tinnitus Loudness Matching (TLM), and Tinnitus Handicap Inventory (THI). The device was well tolerated by patients and no adverse events or serious difficulties using the device were reported. Overall, 68% of patients met the defined compliance threshold. Compliant patients (N = 30) demonstrated statistically significant improvements in mean outcome measures after 10 weeks of treatment: THI (-11.7 pts, p < 0.001), TLM (-7.5dB, p < 0.001), and MML (-9.7dB, p < 0.001). The noncompliant group (N = 14) demonstrated no statistical improvements. This study demonstrates the feasibility and safety of a new bi-modal stimulation device and supports the potential efficacy of this new treatment for tinnitus. © 2016 Neuromod Devices Ltd. Neuromodulation: Technology at the Neural Interface published by Wiley Periodicals, Inc. on behalf of International Neuromodulation Society.

Valganciclovir (VGCV) followed by cytomegalovirus (CMV) hyperimmune globulin compared to VGCV for 200 days in abdominal organ transplant recipients at high risk for CMV infection: A prospective, randomized pilot study.

PubMed

Fleming, James N; Taber, David J; Weimert, Nicole A; Nadig, Satish; McGillicuddy, John W; Bratton, Charles F; Baliga, Prabhakar K; Chavin, Kenneth D

2017-12-01

With the advent of effective antivirals against cytomegalovirus (CMV), use of CMV hyperimmune globulin (HIG) has decreased. Although antiviral prophylaxis in patients at high risk for CMV is effective, many patients still have late infection, never developing antibodies sufficient to achieve immunity. Utilizing a combination of antiviral and CMV HIG may allow patients to achieve immunity and decrease late CMV infections. This was a prospective randomized, open-label, pilot study comparing valganciclovir (VGCV) prophylaxis for 200 days vs VGCV for 100 days followed by CMV HIG in abdominal transplant recipients at high risk for CMV. The primary outcome was a comparison of late CMV disease. Forty patients were randomized to VGCV for 200 days (n = 20) or VGCV for 100 days followed by 3 doses of monthly CMV HIG (n = 20). Numerically, more overall CMV infections occurred in the CMV HIG group (45 vs 20%, P = .09). No differences in overall CMV infections or late CMV disease were seen between groups (20% vs 15%, P = 1.00 and 0 vs 0, P = 1.00). All CMV disease occurred within 200 days, with 63% occurring while patients were on VGCV. No differences were found in toxicities, graft function, or rejection between groups. Patients with CMV infection at any time had a higher body weight than those who did not have an infection (82 vs 95 kg, P = .049). Use of CMV HIG sequentially with prophylaxis may be an effective and affordable prophylactic regimen in abdominal transplant recipients at high risk for CMV, and warrants larger prospective study. Increased monitoring for patients with obesity may be warranted. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Does a 4 diagram manual enable laypersons to operate the Laryngeal Mask Supreme®? A pilot study in the manikin.

PubMed

Schälte, Gereon; Stoppe, Christian; Rossaint, Rolf; Gilles, Laura; Heuser, Maike; Rex, Steffen; Coburn, Mark; Zoremba, Norbert; Rieg, Annette

2012-03-27

Bystander resuscitation plays an important role in lifesaving cardiopulmonary resuscitation (CPR). A significant reduction in the "no-flow-time", quantitatively better chest compressions and an improved quality of ventilation can be demonstrated during CPR using supraglottic airway devices (SADs). Previous studies have demonstrated the ability of inexperienced persons to operate SADs after brief instruction. The aim of this pilot study was to determine whether an instruction manual consisting of four diagrams enables laypersons to operate a Laryngeal Mask Supreme® (LMAS) in the manikin. An instruction manual of four illustrations with speech bubbles displaying the correct use of the LMAS was designed. Laypersons were handed a bag containing a LMAS, a bag mask valve device (BMV), a syringe prefilled with air and the instruction sheet, and were asked to perform and ventilate the manikin as displayed. Time to ventilation was recorded and degree of success evaluated. A total of 150 laypersons took part. Overall 145 participants (96.7%) inserted the LMAS in the manikin in the right direction. The device was inserted inverted or twisted in 13 (8.7%) attempts. Eight (5.3%) individuals recognized this and corrected the position. Within the first 2 minutes 119 (79.3%) applicants were able to insert the LMAS and provide tidal volumes greater than 150 ml (estimated dead space). Time to insertion and first ventilation was 83.2 ± 29 s. No significant difference related to previous BLS training (P = 0.85), technical education (P = 0.07) or gender could be demonstrated (P = 0.25). In manikin laypersons could insert LMAS in the correct direction after onsite instruction by a simple manual with a high success rate. This indicates some basic procedural understanding and intellectual transfer in principle. Operating errors (n = 91) were frequently not recognized and corrected (n = 77). Improvements in labeling and the quality of instructional photographs may reduce individual error and may optimize understanding.

Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial-PROSPECT: a pilot trial.

PubMed

Cook, Deborah J; Johnstone, Jennie; Marshall, John C; Lauzier, Francois; Thabane, Lehana; Mehta, Sangeeta; Dodek, Peter M; McIntyre, Lauralyn; Pagliarello, Joe; Henderson, William; Taylor, Robert W; Cartin-Ceba, Rodrigo; Golan, Eyal; Herridge, Margaret; Wood, Gordon; Ovakim, Daniel; Karachi, Tim; Surette, Michael G; Bowdish, Dawn M E; Lamarche, Daphnee; Verschoor, Chris P; Duan, Erick H; Heels-Ansdell, Diane; Arabi, Yaseen; Meade, Maureen

2016-08-02

Probiotics are live microorganisms that may confer health benefits when ingested. Randomized trials suggest that probiotics significantly decrease the incidence of ventilator-associated pneumonia (VAP) and the overall incidence of infection in critically ill patients. However, these studies are small, largely single-center, and at risk of bias. The aim of the PROSPECT pilot trial was to determine the feasibility of conducting a larger trial of probiotics to prevent VAP in mechanically ventilated patients in the intensive care unit (ICU). In a randomized blinded trial, patients expected to be mechanically ventilated for ≥72 hours were allocated to receive either 1 × 10(10) colony-forming units of Lactobacillus rhamnosus GG or placebo, twice daily. Patients were excluded if they were at increased risk of L. rhamnosus GG infection or had contraindications to enteral medication. Feasibility objectives were: (1) timely recruitment; (2) maximal protocol adherence; (3) minimal contamination; and (4) estimated VAP rate ≥10 %. We also measured other infections, diarrhea, ICU and hospital length of stay, and mortality. Overall, in 14 centers in Canada and the USA, all feasibility goals were met: (1) 150 patients were randomized in 1 year; (2) protocol adherence was 97 %; (3) no patients received open-label probiotics; and (4) the VAP rate was 19 %. Other infections included: bloodstream infection (19.3 %), urinary tract infections (12.7 %), and skin and soft tissue infections (4.0 %). Diarrhea, defined as Bristol type 6 or 7 stools, occurred in 133 (88.7 %) of patients, the median length of stay in ICU was 12 days (quartile 1 to quartile 3, 7-18 days), and in hospital was 26 days (quartile 1 to quartile 3, 14-44 days); 23 patients (15.3 %) died in the ICU. The PROSPECT pilot trial supports the feasibility of a larger trial to investigate the effect of L. rhamnosus GG on VAP and other nosocomial infections in critically ill patients. Clinicaltrials.gov NCT01782755 . Registered on 29 January 2013.

[Academic production on food labeling in Brazil].

PubMed

Câmara, Maria Clara Coelho; Marinho, Carmem Luisa Cabral; Guilam, Maria Cristina; Braga, Ana Maria Cheble Bahia

2008-01-01

To review and discuss academic production (theses and dissertations) on the topic of labeling of prepackaged foods in Brazil. A search of the database maintained by the Coordination for the Development of Higher Education Professionals (CAPES), one of the two Brazilian government research funding and support agencies, was conducted on the following keywords: "rotulagem" (labeling), "rotulagem nutricional" (food labeling) and "rótulo de alimentos" (food labels). The search covered the years 1987 (earliest year available) to 2004. We identified 49 studies on this topic. Content analysis identified three major themes: the extent to which food labels meet specific legal requirements (57.2%); the degree to which consumers understand the information on labels (22.4%); and the labeling of transgenic or genetically-modified foods (20.4%). Food labeling is a frequent topic and is adequately covered by the Brazilian academic production. In most of the studies, ineffective law enforcement appears to be the main factor in the lack of compliance with and disrespect for the food labeling rules and regulations in Brazil.

How do design features influence consumer attention when looking for nutritional information on food labels? Results from an eye-tracking study on pan bread labels.

PubMed

Antúnez, Lucía; Vidal, Leticia; Sapolinski, Alejandra; Giménez, Ana; Maiche, Alejandro; Ares, Gastón

2013-08-01

The aim of this work was to evaluate consumer visual processing of food labels when evaluating the salt content of pan bread labels and to study the influence of label design and nutritional labelling format on consumer attention. A total of 16 pan bread labels, designed according to a full factorial design, were presented to 52 participants, who were asked to decide whether the sodium content of each label was medium or low, while their eye movements were recorded using an eye tracker. Results showed that most participants looked at nutrition labels and the traffic light system to conclude on the salt content of the labels. However, the average percentage of participants who looked at the actual sodium content was much lower. Nutrition information format affected participants' processing of nutrition information. Among other effects, the inclusion of the traffic light system increased participants' attention towards some kind of nutrition information and facilitated its processing, but not its understanding.

Oregon department of transportation small business group twice-monthly payments pilot project : summary report.

DOT National Transportation Integrated Search

2008-07-01

Oregon Department of Transportation (ODOT) recently completed a pilot study on small business payment practices. In the study, three pilot projects were tested where payments to small business contractors were changed from a monthly payment to twice-...

Calorie menu labeling on quick-service restaurant menus: an updated systematic review of the literature

PubMed Central

2011-01-01

Nutrition labels are one strategy being used to combat the increasing prevalence of overweight and obesity in the United States. The Patient Protection and Affordable Care Act of 2010 mandates that calorie labels be added to menu boards of chain restaurants with 20 or more locations. This systematic review includes seven studies published since the last review on the topic in 2008. Authors searched for peer-reviewed studies using PUBMED and Google Scholar. Included studies used an experimental or quasi-experimental design comparing a calorie-labeled menu with a no-calorie menu and were conducted in laboratories, college cafeterias, and fast food restaurants. Two of the included studies were judged to be of good quality, and five of were judged to be of fair quality. Observational studies conducted in cities after implementation of calorie labeling were imprecise in their measure of the isolated effects of calorie labels. Experimental studies conducted in laboratory settings were difficult to generalize to real world behavior. Only two of the seven studies reported a statistically significant reduction in calories purchased among consumers using calorie-labeled menus. The current evidence suggests that calorie labeling does not have the intended effect of decreasing calorie purchasing or consumption. PMID:22152038

Modeling human pilot cue utilization with applications to simulator fidelity assessment.

PubMed

Zeyada, Y; Hess, R A

2000-01-01

An analytical investigation to model the manner in which pilots perceive and utilize visual, proprioceptive, and vestibular cues in a ground-based flight simulator was undertaken. Data from a NASA Ames Research Center vertical motion simulator study of a simple, single-degree-of-freedom rotorcraft bob-up/down maneuver were employed in the investigation. The study was part of a larger research effort that has the creation of a methodology for determining flight simulator fidelity requirements as its ultimate goal. The study utilized a closed-loop feedback structure of the pilot/simulator system that included the pilot, the cockpit inceptor, the dynamics of the simulated vehicle, and the motion system. With the exception of time delays that accrued in visual scene production in the simulator, visual scene effects were not included in this study. Pilot/vehicle analysis and fuzzy-inference identification were employed to study the changes in fidelity that occurred as the characteristics of the motion system were varied over five configurations. The data from three of the five pilots who participated in the experimental study were analyzed in the fuzzy-inference identification. Results indicate that both the analytical pilot/vehicle analysis and the fuzzy-inference identification can be used to identify changes in simulator fidelity for the task examined.

A queueing model of pilot decision making in a multi-task flight management situation

NASA Technical Reports Server (NTRS)

Walden, R. S.; Rouse, W. B.

1977-01-01

Allocation of decision making responsibility between pilot and computer is considered and a flight management task, designed for the study of pilot-computer interaction, is discussed. A queueing theory model of pilot decision making in this multi-task, control and monitoring situation is presented. An experimental investigation of pilot decision making and the resulting model parameters are discussed.

Lunar Analog

NASA Technical Reports Server (NTRS)

Cromwell, Ronita L.

2009-01-01

In this viewgraph presentation, a ground-based lunar analog is developed for the return of manned space flight to the Moon. The contents include: 1) Digital Astronaut; 2) Bed Design; 3) Lunar Analog Feasibility Study; 4) Preliminary Data; 5) Pre-pilot Study; 6) Selection of Stockings; 7) Lunar Analog Pilot Study; 8) Bed Design for Lunar Analog Pilot.

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

Potential Negative Effects of Antimicrobial Allergy Labelling on Patient Care: A Systematic Review.

PubMed

Wu, Julie Hui-Chih; Langford, Bradley J; Schwartz, Kevin L; Zvonar, Rosemary; Raybardhan, Sumit; Leung, Valerie; Garber, Gary

2018-01-01

Antimicrobial allergy labels, either self-reported or placed in a patient's medical record, are common, but in many cases they are not associated with a true immunoglobulin E-mediated allergic response. To assess the impact of antimicrobial allergy labels on antimicrobial prescribing, resource utilization, and clinical outcomes. The MEDLINE, Embase, CINAHL, and Scopus electronic databases were searched for the period 1990 to January 2016. Controlled studies with the objective of assessing antimicrobial prescribing, resource utilization, and/or clinical outcomes associated with antimicrobial allergy labels were included. The search identified 560 unique citations, of which 7 articles met the inclusion criteria. One additional article identified by an expert in the field was also included. Four of the identified papers were limited to penicillin or other β-lactam allergies. Six studies noted differences in antibiotic selection between patients with allergy labels and those without such labels. Broader-spectrum or second-line agents (e.g., vancomycin, clindamycin, and fluoroquinolones) were more commonly prescribed for patients with penicillin allergy labels. Antibiotic therapy costs were significantly higher for patients with allergy labels than for those without. The impact of allergy labels on clinical outcomes was mixed. One study indicated a longer length of hospital stay, 2 studies reported higher readmission rates, and 1 study reported a higher rate of antibiotic-resistant organisms for patients with allergy labels. Most of the available literature is limited to penicillin or β-lactam allergy. The growing body of knowledge supports the concept that β-lactam allergy labels are not benign and that labelling in the absence of a true allergy has a negative effect on patient care. Allergy labelling appears to be associated with suboptimal antibiotic selection, greater treatment costs, prolonged length of stay, greater readmission rates, and higher prevalence of antibiotic-resistant organisms. There is an opportunity for antimicrobial stewardship programs to implement systematic allergy verification to optimize antimicrobial therapy and improve patient care.

A simulator evaluation of an automatic terminal approach system

NASA Technical Reports Server (NTRS)

Hinton, D. A.

1983-01-01

The automatic terminal approach system (ATAS) is a concept for improving the pilot/machine interface with cockpit automation. The ATAS can automatically fly a published instrument approach by using stored instrument approach data to automatically tune airplane avionics, control the airplane's autopilot, and display status information to the pilot. A piloted simulation study was conducted to determine the feasibility of an ATAS, determine pilot acceptance, and examine pilot/ATAS interaction. Seven instrument-rated pilots each flew four instrument approaches with a base-line heading select autopilot mode. The ATAS runs resulted in lower flight technical error, lower pilot workload, and fewer blunders than with the baseline autopilot. The ATAS status display enabled the pilots to maintain situational awareness during the automatic approaches. The system was well accepted by the pilots.

Revised NEO Personality Inventory profiles of male and female U.S. Air Force pilots.

PubMed

Callister, J D; King, R E; Retzlaff, P D; Marsh, R W

1999-12-01

The study of pilot personality characteristics has a long and controversial history. Personality characteristics seem to be fairly poor predictors of training outcome; however, valid personality assessment is essential to clinical psychological evaluations. Therefore, the personality characteristics of pilots must be studied to ensure valid clinical assessment. This paper describes normative personality characteristics of U.S. Air Force pilots based on the Revised NEO Personality Inventory profiles of 1,301 U.S. Air Force student pilots. Compared with male adult norms, male student pilots had higher levels of extraversion and lower levels of agreeableness. Compared with female adult norms, female student pilots had higher levels of extraversion and openness and lower levels of agreeableness. Descriptive statistics and percentile tables for the five domain scores and 30 facet scores are provided for clinical use, and a case vignette is provided as an example of the clinical utility of these U.S. Air Force norms.

Head positioning for high +Gz loads: an analysis of the techniques used by F/A-18 pilots.

PubMed

Newman, D G

1997-08-01

A study was undertaken among Royal Australian Air Force fighter pilots to determine whether, as an occupational group, they had developed any particular protective head positioning strategies in order to minimize their risk of sustaining a +Gz-induced neck injury during air combat maneuvering. There were 42 F/A-18 Hornet pilots who responded to an anonymous questionnaire which asked about head positioning strategies. Of these, 29 pilots reported using a protective strategy. Several pilots reported using several different techniques. The most popular strategy reported was positioning the head prior to the application of +Gz (13 respondents). Eleven pilots reported using aircraft structures to wedge or brace their heads against. The results of this study show that fighter pilots who are regularly exposed to high +Gz forces develop an individualized approach to protecting their cervical spines from +Gz-induced injury.

Alcohol consumers' attention to warning labels and brand information on alcohol packaging: Findings from cross-sectional and experimental studies.

PubMed

Kersbergen, Inge; Field, Matt

2017-01-26

Alcohol warning labels have a limited effect on drinking behavior, potentially because people devote minimal attention to them. We report findings from two studies in which we measured the extent to which alcohol consumers attend to warning labels on alcohol packaging, and aimed to identify if increased attention to warning labels is associated with motivation to change drinking behavior. Study 1 (N = 60) was an exploratory cross-sectional study in which we used eye-tracking to measure visual attention to brand and health information on alcohol and soda containers. In study 2 (N = 120) we manipulated motivation to reduce drinking using an alcohol brief intervention (vs control intervention) and measured heavy drinkers' attention to branding and warning labels with the same eye-tracking paradigm as in study 1. Then, in a separate task we experimentally manipulated attention by drawing a brightly colored border around health (or brand) information before measuring participants' self-reported drinking intentions for the subsequent week. Study 1 showed that participants paid minimal attention to warning labels (7% of viewing time). Participants who were motivated to reduce drinking paid less attention to alcohol branding and alcohol warning labels. Results from study 2 showed that the alcohol brief intervention decreased attention to branding compared to the control condition, but it did not affect attention to warning labels. Furthermore, the experimental manipulation of attention to health or brand information did not influence drinking intentions for the subsequent week. Alcohol consumers allocate minimal attention to warning labels on alcohol packaging and even if their attention is directed to these warning labels, this has no impact on their drinking intentions. The lack of attention to warning labels, even among people who actively want to cut down, suggests that there is room for improvement in the content of health warnings on alcohol packaging.

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.

When zero is greater than one: consumer misinterpretations of nutrition labels.

PubMed

Graham, Dan J; Mohr, Gina S

2014-12-01

Front-of-package (FOP) nutrition labels are increasingly used by food manufacturers. A call to regulate the content and format of these labels resulted in recommendations by the Institute of Medicine (IOM) for standardized FOP labels that clearly communicate packaged foods' healthfulness. It is currently unclear how consumers would interpret and use these proposed labels. This research addresses psychological factors affecting the efficacy of FOP label use. It was hypothesized that IOM's proposed 0- to 3-point rating scale would produce the zero-comparison effect, leading to more favorable evaluations than are warranted for the least healthful products (i.e., those earning zero nutritional points). In two studies (Study 1, n = 68; Study 2, n = 101), participants evaluated products containing FOP labels on the basis of IOM recommendations. Primary outcomes were perceived product healthfulness and purchase intentions. Study 1 demonstrated that less-healthful products were rated by study participants to be equally healthful as more-healthful products. The relationship between FOP rating and purchase intentions was mediated by perceived healthfulness. Biases in product healthfulness ratings were exacerbated for consumers with higher (vs. lower) health concern. Study 2 demonstrated that by changing the rating scale from 0-3 to 1-4, consumers avoid the zero-comparison effect and accurately evaluate products' healthfulness. This research has implications for theory and policy in the domains of nutrition labeling and consumer health. Specifically, FOP labels can help consumers identify healthful options, but products receiving zero nutritional points may be misidentified as healthful; a simple label modification can prevent this confusion.

Pilot Age and Error in Air-Taxi Crashes

PubMed Central

Rebok, George W.; Qiang, Yandong; Baker, Susan P.; Li, Guohua

2010-01-01

Introduction The associations of pilot error with the type of flight operations and basic weather conditions are well documented. The correlation between pilot characteristics and error is less clear. This study aims to examine whether pilot age is associated with the prevalence and patterns of pilot error in air-taxi crashes. Methods Investigation reports from the National Transportation Safety Board for crashes involving non-scheduled Part 135 operations (i.e., air taxis) in the United States between 1983 and 2002 were reviewed to identify pilot error and other contributing factors. Crash circumstances and the presence and type of pilot error were analyzed in relation to pilot age using Chi-square tests. Results Of the 1751 air-taxi crashes studied, 28% resulted from mechanical failure, 25% from loss of control at landing or takeoff, 7% from visual flight rule conditions into instrument meteorological conditions, 7% from fuel starvation, 5% from taxiing, and 28% from other causes. Crashes among older pilots were more likely to occur during the daytime rather than at night and off airport than on airport. The patterns of pilot error in air-taxi crashes were similar across age groups. Of the errors identified, 27% were flawed decisions, 26% were inattentiveness, 23% mishandled aircraft kinetics, 15% mishandled wind and/or runway conditions, and 11% were others. Conclusions Pilot age is associated with crash circumstances but not with the prevalence and patterns of pilot error in air-taxi crashes. Lack of age-related differences in pilot error may be attributable to the “safe worker effect.” PMID:19601508

Human risk factors associated with pilots in runway excursions.

PubMed

Chang, Yu-Hern; Yang, Hui-Hua; Hsiao, Yu-Jung

2016-09-01

A breakdown analysis of civil aviation accidents worldwide indicates that the occurrence of runway excursions represents the largest portion among all aviation occurrence categories. This study examines the human risk factors associated with pilots in runway excursions, by applying a SHELLO model to categorize the human risk factors and to evaluate the importance based on the opinions of 145 airline pilots. This study integrates aviation management level expert opinions on relative weighting and improvement-achievability in order to develop four kinds of priority risk management strategies for airline pilots to reduce runway excursions. The empirical study based on experts' evaluation suggests that the most important dimension is the liveware/pilot's core ability. From the perspective of front-line pilots, the most important risk factors are the environment, wet/containment runways, and weather issues like rain/thunderstorms. Finally, this study develops practical strategies for helping management authorities to improve major operational and managerial weaknesses so as to reduce the human risks related to runway excursions. Copyright © 2016 Elsevier Ltd. All rights reserved.

Study of the use of a nonlinear, rate limited, filter on pilot control signals

NASA Technical Reports Server (NTRS)

Adams, J. J.

1977-01-01

The use of a filter on the pilot's control output could improve the performance of the pilot-aircraft system. What is needed is a filter with a sharp high frequency cut-off, no resonance peak, and a minimum of lag at low frequencies. The present investigation studies the usefulness of a nonlinear, rate limited, filter in performing the needed function. The nonlinear filter is compared with a linear, first order filter, and no filter. An analytical study using pilot models and a simulation study using experienced test pilots was performed. The results showed that the nonlinear filter does promote quick, steady maneuvering. It is shown that the nonlinear filter attenuates the high frequency remnant and adds less phase lag to the low frequency signal than does the linear filter. It is also shown that the rate limit in the nonlinear filter can be set to be too restrictive, causing an unstable pilot-aircraft system response.

Effects of testosterone on visuospatial function and verbal fluency in postmenopausal women: results from a functional magnetic resonance imaging pilot study.

PubMed

Davis, Susan R; Davison, Sonia L; Gavrilescu, Maria; Searle, Karissa; Gogos, Andrea; Rossell, Susan L; Egan, Gary F; Bell, Robin J

2014-04-01

This study aims to investigate the effects of testosterone on cognitive performance during functional magnetic resonance imaging (fMRI) in healthy estrogen-treated postmenopausal women. This was an open-label study in which postmenopausal women on nonoral estrogen therapy were treated with transdermal testosterone for 26 weeks. Women performed tests of verbal fluency (number of words) and mental rotation (reaction time and accuracy) during pretreatment and posttreatment fMRI. Blood oxygen level-dependent (BOLD) signal intensity was measured during fMRI tasks. Nine women with a mean (SD) age of 55.4 (3.8) years completed the study. Twenty-six weeks of testosterone therapy was associated with significant decreases in BOLD intensity during the mental rotation task in the right superior parietal, left inferior parietal, and left precuneus regions, and during the verbal fluency task in the left inferior frontal gyrus, left lingual gyrus, and medial frontal gyrus (all P < 0.05), with no change in task performance, accuracy, or speed. Testosterone therapy is associated with reduced BOLD signal activation in key anatomical areas during fMRI verbal fluency and visuospatial tasks in healthy estrogen-treated postmenopausal women. Our interpretation is that testosterone therapy facilitates preservation of cognitive function with less neuronal recruitment.

Airplane pilot mental health and suicidal thoughts: a cross-sectional descriptive study via anonymous web-based survey.

PubMed

Wu, Alexander C; Donnelly-McLay, Deborah; Weisskopf, Marc G; McNeely, Eileen; Betancourt, Theresa S; Allen, Joseph G

2016-12-15

The Germanwings Flight 9525 crash has brought the sensitive subject of airline pilot mental health to the forefront in aviation. Globally, 350 million people suffer from depression-a common mental disorder. This study provides further information on this important topic regarding mental health especially among female airline pilots. This is the first study to describe airline pilot mental health-with a focus on depression and suicidal thoughts-outside of the information derived from aircraft accident investigations, regulated health examinations, or identifiable self-reports, which are records protected by civil aviation authorities and airline companies. This is a descriptive cross-sectional study via an anonymous web-based survey administered between April and December 2015. Pilots were recruited from unions, airline companies, and airports via convenience sampling. Data analysis included calculating absolute number and prevalence of health characteristics and depression scores. One thousand eight hundred thirty seven (52.7%) of the 3485 surveyed pilots completed the survey, with 1866 (53.5%) completing at least half of the survey. 233 (12.6%) of 1848 airline pilots responding to the Patient Health Questionnaire 9 (PHQ-9), and 193 (13.5%) of 1430 pilots who reported working as an airline pilot in the last seven days at time of survey, met depression threshold-PHQ-9 total score ≥ 10. Seventy-five participants (4.1%) reported having suicidal thoughts within the past two weeks. We found a significant trend in proportions of depression at higher levels of use of sleep-aid medication (trend test z = 6.74, p < 0.001) and among those experiencing sexual harassment (z = 3.18, p = 0.001) or verbal harassment (z = 6.13, p < 0.001). Hundreds of pilots currently flying are managing depressive symptoms perhaps without the possibility of treatment due to the fear of negative career impacts. This study found 233 (12.6%) airline pilots meeting depression threshold and 75 (4.1%) pilots reporting having suicidal thoughts. Although results have limited generalizability, there are a significant number of active pilots suffering from depressive symptoms. We recommend airline organizations increase support for preventative mental health treatment. Future research will evaluate additional risk factors of depression such as sleep and circadian rhythm disturbances.

Self-Relevant Disgust and Self-Harm Urges in Patients with Borderline Personality Disorder and Depression: A Pilot Study with a Newly Designed Psychological Challenge

PubMed Central

Abdul-Hamid, Sawsan; Denman, Chess; Dudas, Robert B.

2014-01-01

Background Borderline personality disorder (BPD) is a common psychiatric condition associated with self-harm. Self-harm is poorly understood and there is currently no treatment for acute presentations with self-harm urges. Objectives By using a new task (Self-relevant Task; SRT), to explore emotions related to one's own person (PERSON task) and body (BODY task), to study the correlations of these emotions, specifically disgust, with self-harm urge level changes, and to test the task's potential to be developed into an experimental model of self-harming for treatment trials. Methods 17 BPD patients, 27 major depressive disorder (MDD) patients, and 25 healthy volunteers performed the SRT. Emotion labels were extracted from task narratives and disgust and self-harm urge level changes measured by visual analogue scales. We used validated rating scales to measure symptom severity. Results The SRT was effective at inducing negative emotions and self-harm urge changes. Self-harm urge changes correlated with borderline symptom severity. Post-task disgust levels on the visual analogue scales were higher in BPD patients than in healthy controls in the PERSON task, and higher than in both control groups in the BODY task. Changes in disgust levels during the task were significantly greater in the patient groups. Post-task disgust levels or changes in disgust were not associated with self-harm urge changes (except the latter in MDD in the PERSON task), but self-harm urge changes and disgust (but no other emotion) narrative labels were on a whole sample level. Conclusion Although associations with the analogue scale measures were not significant, self-disgust reported in the narrative of patients may be associated with a higher probability of self-harm urges. Further research with larger sample sizes is needed to confirm this relationship and to examine whether reducing self-disgust could reduce self-harm urges. The SRT was effective and safe, and could be standardized for experimental studies. PMID:24956153

Extracorporeal adsorption therapy: A Method to improve targeted radiation delivered by radiometal-labeled monoclonal antibodies.

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

Nemecek, Eneida R.; Green, Damian J.; Fisher, Darrell R.

2008-04-01

Many investigators have demonstrated the ability to treat hematologic malignancies with radiolabeled monoclonal antibodies targeting hematopoietic antigens such as anti-CD20 and anti-CD45. [1-5] Although the remission rates achieved with radioimmunotherapy (RIT) are relatively high, many patients subsequently relapse presumably due to suboptimal delivery of enough radiation to eradicate the malignancy. The dose-response of leukemia and lymphoma to radiation has been proven. Substantial amounts of radiation can be delivered by RIT if followed by hematopoietic cell transplantation to rescue the bone marrow from myeloablation.[ref] However, the maximum dose of RIT that can be used is still limited by toxicity to normalmore » tissues affected by nonspecific delivery of radiation. Efforts to improve RIT focus on improving the therapeutic ratios of radiation in target versus non-target tissues by removing the fraction of radioisotope that fails to bind to target tissues and circulates freely in the bloodstream perfusing non-target tissues. Our group and others have explored several alternatives for removal of unbound circulating antibody. [refs] One such method, extracorporeal adsorption therapy (ECAT) consists of removing unbound antibody by a method similar to plasmapheresis after critical circulation time and distribution of antibody into target tissues have been achieved. Preclinical studies of ECAT in murine xenograft models demonstrated significant improvement in therapeutic ratios of radioactivity. Chen and colleagues demonstrated that a 2-hour ECAT procedure could remove 40 to 70% of the radioactivity from liver, lung and spleen. [ref] Although isotope concentration in the tumor was initially unaffected, a 50% decrease was noted approximately 36 hours after the procedure. This approach was also evaluated in a limited phase I pilot study of patients with refractory B-cell lymphoma. [ref] After radiographic confirmation of tumor localization of a test dose of anti-CD20 antibody labeled with indium-111 (111In), seven patients received RIT with anti-CD20 antibody labeled with indium-111 for biokinetics and dosimetry, and therapeutic doses of antibody labeled with yttrium-90 (90Y). Performing the ECAT procedure at a rate that such that one blood volume per hour were circulated for 3 hours, resulted in mean radioactivity depletion of 96% in whole blood, 49% in whole body 49%, 62% in the lungs and 40% in liver and kidneys. There was no sufficient data to determine whether there was an improvement in the relative delivery of radiation to the tumor compared to normal organs by performing ECAT, but pharmacokinetic modeling studies suggested a potential therapeutic advantage using this approach. [refs] To evaluate the potential therapeutic advantages of ECAT, we performed biodistribution studies in nonhuman primates comparing the therapeutic ratios of radiation delivered using this approach to those delivered by conventional RIT alone. In addition, we evaluated lutetium-177 (177Lu) as an alternative isotope to optimize the delivery of RIT by improving the therapeutic index (target to non-target ratio)« less

Unbearable weight: young adult women's experiences of being overweight.

PubMed

Yu-Jen, Chang; Yiing-Mei, Liou; Shuh-Jen, Sheu; Mei-Yen, Chen

2004-06-01

Being overweight is a hazard to health. Overweight people have a very negative image due to the marketing strategies for weight reduction and beauty products. Young women establishing self-image, seeking affirmation of social peers, and looking for potential mates are usually concerned about their weight and figure. To investigate the experience of young women who think they are overweight, how they come to think in this way, and the impact of this thinking, this qualitative pilot study conducted semi-structured interviews with five participants. On the basis of the qualitative method, data was subjected to constant comparison and content analysis. The phenomenon can thus be described in three major categories: (1) Social labeling of the overweight - a slim image is overwhelmingly preferred; (2) Pursuing attractiveness or health - a self-struggling process; (3) Weight reduction and self control - an endless struggle. The result of the study suggests there is a need for a competitive image to counter current obsessions with painfully slender figures in society. To protect the public's mental and physical health, nurses should play an active role in weight education based on a deeper and more dynamic understanding of being overweight.

Rilonacept for the treatment of cryopyrin-associated periodic syndromes (CAPS).

PubMed

Hoffman, Hal M

2009-04-01

Cryopyrin-associated periodic syndromes (CAPS) encompass a group of rare inherited, autoinflammatory disorders that represent a spectrum of one disease with varying degrees of severity. Until recently, there was no effective treatment for CAPS, but identification of the genetic basis of CAPS highlighted the pathogenic role of IL-1beta. Rilonacept is a recently FDA approved biologic therapy for CAPS with high affinity for IL-1beta. Limited pharmacological data has been reported to date. A review of the phamacokinetics and pharmacodynamics data as well as the results of a pilot study and Phase III placebo-controlled trials of rilonacept in CAPS. Unpublished data on an open-label extension study in adult and pediatric subjects is also reviewed. Rilonacept produced rapid and profound improvements in symptoms and also reduced high-sesitivity C-reactive protein levels and normalized elevated serum amyloid A concentrations, an important risk factor for amyloidosis. The primary adverse events were injection- site reactions and upper respiratory tract infections. Rilonacept, the only IL-1 Trap, is the first of many novel IL-1-targeted therapies being developed. In a very short time it has changed the lives of CAPS patients.

Safety and Efficacy of Lysergic Acid Diethylamide-Assisted Psychotherapy for Anxiety Associated With Life-threatening Diseases

PubMed Central

Gasser, Peter; Holstein, Dominique; Michel, Yvonne; Doblin, Rick; Yazar-Klosinski, Berra; Passie, Torsten; Brenneisen, Rudolf

2014-01-01

Abstract A double-blind, randomized, active placebo-controlled pilot study was conducted to examine safety and efficacy of lysergic acid diethylamide (LSD)-assisted psychotherapy in 12 patients with anxiety associated with life-threatening diseases. Treatment included drug-free psychotherapy sessions supplemented by two LSD-assisted psychotherapy sessions 2 to 3 weeks apart. The participants received either 200 μg of LSD (n = 8) or 20 μg of LSD with an open-label crossover to 200 μg of LSD after the initial blinded treatment was unmasked (n = 4). At the 2-month follow-up, positive trends were found via the State-Trait Anxiety Inventory (STAI) in reductions in trait anxiety (p = 0.033) with an effect size of 1.1, and state anxiety was significantly reduced (p = 0.021) with an effect size of 1.2, with no acute or chronic adverse effects persisting beyond 1 day after treatment or treatment-related serious adverse events. STAI reductions were sustained for 12 months. These results indicate that when administered safely in a methodologically rigorous medically supervised psychotherapeutic setting, LSD can reduce anxiety, suggesting that larger controlled studies are warranted. PMID:24594678

Safety and efficacy of lysergic acid diethylamide-assisted psychotherapy for anxiety associated with life-threatening diseases.

PubMed

Gasser, Peter; Holstein, Dominique; Michel, Yvonne; Doblin, Rick; Yazar-Klosinski, Berra; Passie, Torsten; Brenneisen, Rudolf

2014-07-01

A double-blind, randomized, active placebo-controlled pilot study was conducted to examine safety and efficacy of lysergic acid diethylamide (LSD)-assisted psychotherapy in 12 patients with anxiety associated with life-threatening diseases. Treatment included drug-free psychotherapy sessions supplemented by two LSD-assisted psychotherapy sessions 2 to 3 weeks apart. The participants received either 200 μg of LSD (n = 8) or 20 μg of LSD with an open-label crossover to 200 μg of LSD after the initial blinded treatment was unmasked (n = 4). At the 2-month follow-up, positive trends were found via the State-Trait Anxiety Inventory (STAI) in reductions in trait anxiety (p = 0.033) with an effect size of 1.1, and state anxiety was significantly reduced (p = 0.021) with an effect size of 1.2, with no acute or chronic adverse effects persisting beyond 1 day after treatment or treatment-related serious adverse events. STAI reductions were sustained for 12 months. These results indicate that when administered safely in a methodologically rigorous medically supervised psychotherapeutic setting, LSD can reduce anxiety, suggesting that larger controlled studies are warranted.

Pharmaceuticals Safety Practices-A Comparative Pilot Study

PubMed Central

Tawfik, Kamilia A.; Jabeen, Arshia

2013-01-01

Introduction The safety of medicine is essential for the safety of patients. Inappropriate drug storage, expiration dates, sharing prescription drugs, self medication habits and misuse of some drugs are contributing factors affecting medication safety. One or more of these factors may lead to serious health complications and even death. Objectives The purpose of this study was to highlight the common errors and pharmaceutical malpractices that people usually engage in on a daily basis and to correlate these to culture, gender and educational levels. This may spread awareness in an easy and understandable manner and provide certain guidelines to drug consumers ensuring that pharmaceutical preparations are used correctly and safely. Methods Two hundred questionnaires were randomly distributed in two countries; Saudi Arabia and India. The collected data were statistically analyzed. Outcomes and conclusion Results showed that alarming percentages of various participants were using pharmaceuticals inappropriately due to carelessness, unawareness or intentional mistakes. Therefore, active participation by health care professionals is essential for the prevention of drug misuse. Increasing population awareness about self medication, products expiration, pharmaceuticals labels and optimum storage conditions would minimize the adverse effects and may even be life saving. PMID:24533025

Memantine reduces stealing behavior and impulsivity in kleptomania: a pilot study.

PubMed

Grant, Jon E; Odlaug, Brian L; Schreiber, Liana R N; Chamberlain, Samuel R; Won Kim, Suck

2013-03-01

Kleptomania is characterized by repetitive stealing behavior and has been associated with deleterious unwanted outcomes including forensic contact and increased rates of suicidal behavior. Very few trials have been conducted to investigate pharmacological treatment options for this neglected condition. Memantine is an NMDA-receptor antagonist that has shown promising results in the treatment of other behavioral addictions and substance addictions. Twelve individuals with kleptomania received memantine (10 mg/day, titrated to 30 mg/day maximum depending on clinical response and tolerability) over the course of 8 weeks, in an open-label trial. The effects of treatment were quantified using well-validated measures and select neurocognitive tests (last observation carried forward analyses). Kleptomania disease severity scores decreased across all measures considered, and 11 (91.7%) of the participants met the responder criteria (35% improvement on the primary effectiveness measure plus CGI improved/very much improved; significant improvements were also observed in terms of mood, anxiety, and disability scores along with a significant improvement in stop-signal response inhibition. Memantine was generally well tolerated. This study shows the effectiveness of memantine in reducing urges to shoplift and shoplifting behavior along with improving impulsivity, mood, anxiety, and psychosocial functioning.

Pilot Convective Weather Decision Making in En Route Airspace

NASA Technical Reports Server (NTRS)

Wu, Shu-Chieh; Gooding, Cary L.; Shelley, Alexandra E.; Duong, Constance G.; Johnson, Walter W.

2012-01-01

The present research investigates characteristics exhibited in pilot convective weather decision making in en route airspace. In a part-task study, pilots performed weather avoidance under various encounter scenarios. Results showed that the margins of safety that pilots maintain from storms are as fluid as deviation decisions themselves.

A Pilot Study of Creatine as a Novel Treatment for Depression in Methamphetamine Using Females

PubMed Central

Hellem, Tracy L.; Sung, Young-Hoon; Shi, Xian-Feng; Pett, Marjorie A.; Latendresse, Gwen; Morgan, Jubel; Huber, Rebekah S.; Kuykendall, Danielle; Lundberg, Kelly J.; Renshaw, Perry F.

2015-01-01

Objective Depression among methamphetamine users is more prevalent in females than males, but gender specific treatment options for this comorbidity have not been described. Reduced brain phosphocreatine levels have been shown to be lower in female methamphetamine users compared to males, and, of relevance, studies have demonstrated an association between treatment resistant depression and reduced brain phosphocreatine concentrations. The nutritional supplement creatine monohydrate has been reported to reduce symptoms of depression in female adolescents and adults taking antidepressants, as well as to increase brain phosphocreatine in healthy volunteers. Therefore, the purpose of this pilot study was to investigate creatine monohydrate as a treatment for depression in female methamphetamine users. Methods Fourteen females with depression and comorbid methamphetamine dependence were enrolled in an 8 week open label trial of 5 grams of daily creatine monohydrate and of these 14, eleven females completed the study. Depression was measured using the Hamilton Depression Rating Scale (HAMD) and brain phosphocreatine levels were measured using phosphorus magnetic resonance spectroscopy pre- and post-creatine treatment. Secondary outcome measures included anxiety symptoms, measured with the Beck Anxiety Inventory (BAI), as well as methamphetamine use, monitored by twice weekly urine drug screens and self-reported use. Results The results of a linear mixed effects repeated measures model showed significantly reduced HAMD and BAI scores as early as week 2 when compared to baseline scores. This improvement was maintained through study completion. Brain phosphocreatine concentrations were higher at the second phosphorus magnetic resonance spectroscopy scan compared to the baseline scan; Mbaseline = 0.223 (SD = 0.013) vs. Mpost-treatment = 0.233 (SD = 0.009), t(9) = 2.905, p < .01, suggesting that creatine increased phosphocreatine levels. Also, a reduction in methamphetamine positive urine drug screens of greater than 50% was observed by week 6. Finally, creatine was well tolerated and adverse events that were related to gastrointestinal symptoms and muscle cramping were determined as possibly related to creatine. Conclusions The current study suggests that creatine treatment may be a promising therapeutic approach for females with depression and comorbid methamphetamine dependence. Clinical Trial Registration This study is registered on clinicaltrials.gov (NCT01514630). PMID:26457568

Comparison of the effects of energy drink versus caffeine supplementation on indices of 24-hour ambulatory blood pressure.

PubMed

Franks, Amy M; Schmidt, Julia M; McCain, Keith R; Fraer, Mony

2012-02-01

Cardiovascular events associated with energy drink consumption have been reported, but few data exist to delineate the hemodynamic effects of energy drinks. To compare the effects of an energy drink versus caffeine supplementation on blood pressure (BP) indices as measured by 24-hour ambulatory BP monitoring (ABPM). Healthy, nonsmoking, normotensive volunteers (aged 18-45 years) taking no medications were enrolled in a single-center, open-label, 2-period crossover pilot study. During each study period, subjects received either an energy drink (Red Bull Energy Drink, each dose containing 80 mg of caffeine and 1000 mg of taurine in an 8.3-oz serving) or a control (compounded caffeine solution, each dose containing 80 mg of caffeine solution in 8 oz of bottled water) at 0800, 1100, 1500, and 1900 hours and underwent 24-hour ABPM. The study periods were separated by a washout period (4-30 days). Mean 24-hour, daytime, and nighttime systolic (SBP), diastolic (DBP), and mean arterial (MAP) BP; BP load; and percent nocturnal dipping were compared between study periods. Nine subjects (5 females, mean [SD] age 27.7 [5.0] years) completed the study. Mean 24-hour SBP (123.2 vs 117.4 mm Hg, p = 0.04), DBP (73.6 vs 68.2 mm Hg, p = 0.02), and MAP (90.1 vs 84.8 mm Hg, p = 0.03) were significantly higher during energy drink supplementation versus caffeine supplementation. Daytime DBP (77.0 vs 72.0 mm Hg, p = 0.04) also was significantly higher with the energy drink versus caffeine supplementation. Trends in higher daytime SBP (127.0 vs 121.9 mm Hg, p = 0.05) and MAP (93.6 vs 88.6 mm Hg, p = 0.05) were recorded with energy drink supplementation versus caffeine supplementation. Nighttime SBP and DBP loads were significantly higher with the energy drink, but nocturnal dipping did not differ significantly between study periods. Single-day energy drink supplementation increased mean 24-hour and daytime BP compared to caffeine control in this pilot study. Additional research is warranted to better understand the hemodynamic effects of energy drink consumption.

Rationale and design of platelet transfusions in haematopoietic stem cell transplantation: the PATH pilot study.

PubMed

Tay, Jason; Allan, David; Beattie, Sara; Bredeson, Christopher; Fergusson, Dean; Maze, Dawn; Sabloff, Mitchell; Thavorn, Kednapa; Tinmouth, Alan

2016-10-24

In patients with transient thrombocytopenia being treated with high-dose chemotherapy followed by stem cell rescue-haematopoietic stem cell transplantation (HSCT), prophylactic transfusions are standard therapy to prevent bleeding. However, a recent multicentre trial suggests that prophylactic platelet transfusions in HSCT may not be necessary. Additionally, the potential overuse of platelet products places a burden on a scarce healthcare resource. Moreover, the benefit of prophylactic platelet transfusions to prevent clinically relevant haemorrhage is debatable. Current randomised data compare different thresholds for administering prophylactic platelets or prophylactic versus therapeutic platelet transfusions. An alternative strategy involves prescribing prophylactic antifibrinolytic agents such as tranexamic acid to prevent bleeding. This report describes the design of an open-labelled randomised pilot study comparing the prophylactic use of oral tranexamic acid with platelet transfusions in the setting of autologous HSCT. In 3-5 centres, 100 patients undergoing autologous HSCT will be randomly assigned to either a prophylactic tranexamic acid or prophylactic platelets bleeding prevention strategy-based daily platelet values up to 30 days post-transplant. The study will be stratified by centre and type of transplant. The primary goal is to demonstrate study feasibility while collecting clinical outcomes on (1) WHO and Bleeding Severity Measurement Scale (BSMS), (2) transplant-related mortality, (3) quality of life, (4) length of hospital stay, (5) intensive care unit admission rates, (6) Bearman toxicity scores, (7) incidence of infections, (8) transfusion requirements, (9) adverse reactions and (10) economic analyses. This study is funded by a peer-reviewed grant from the Canadian Institutes of Health Research (201 503) and is registered on Clinicaltrials.gov NCT02650791. It has been approved by the Ottawa Health Science Network Research Ethics Board. Study results will presented at national and international conferences. Importantly, the results of this trial will inform the feasibility and conduct of a larger study. NCT02650791; Pre-results. 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/.

The power of putting a label on it: green labels weigh heavier than contradicting product information for consumers' purchase decisions and post-purchase behavior.

PubMed

Hahnel, Ulf J J; Arnold, Oliver; Waschto, Michael; Korcaj, Liridon; Hillmann, Karen; Roser, Damaris; Spada, Hans

2015-01-01

Green products are appealing. Thus, labeling products as environmentally friendly is an effective strategy to increase sales. However, the labels often promise more than the products can actually deliver. In the present research, we examined the expectation that consumers with high ecological motivation have strong preferences for green-labeled products - even when presented product information contradicts the label's image. This unsettling hypothesis is grounded in the labels' potential to create a cognitive match between the labeled product and consumers' motives. For labels indicating environmental friendliness (green product labels), this link should be strongest when consumers' ecological motivation is high. Findings in a series of three experiments support our assumption, showing that consumers with high ecological motivation had strong preferences (i.e., product evaluations, purchase intentions, and simulated purchase decisions) for green-labeled products as compared to consumers with low ecological motivation (Studies 1-3). Crucially, these preferences were robust, despite contradicting environmental product information (Studies 1 and 2). We extended our findings by additionally examining the impact of product labels and motivation on moral self-regulation processes. This was established by assessing participants' pro-social behavior after the purchase task: participants with high ecological motivation acted, consistent with their motives, more pro-socially in post-decision occasions. In accordance with moral cleansing effects, pro-social behavior was intensified after purchasing conventional products (Studies 2 and 3). Green labels protected participants with high ecological motivation from moral threats due to the purchase, thus making pro-social behavior less likely. Findings suggest that highly ecologically motivated consumers are most susceptible to green labels, which may override detailed product information.

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.

Feasibility and Pilot Studies in Palliative Care Research: A Systematic Review.

PubMed

Jones, Terry A; Olds, Timothy S; Currow, David C; Williams, Marie T

2017-07-01

Feasibility and pilot study designs are common in palliative care research. Finding standard guidelines on the structure and reporting of these study types is difficult. In feasibility and pilot studies in palliative care research, to determine 1) how commonly a priori feasibility are criteria reported and whether results are subsequently reported against these criteria? and 2) how commonly are participants' views on acceptability of burden of the study protocol assessed? Four databases (OVID Medline, EMBASE, CINAHL, and PubMed via caresearch.com.au.) were searched. Search terms included palliative care, terminal care, advance care planning, hospice, pilot, feasibility, with a publication date between January 1, 2012 and December 31, 2013. Articles were selected and appraised by two independent reviewers. Fifty-six feasibility and/or pilot studies were included in this review. Only three studies had clear a priori criteria to measure success. Sixteen studies reported participant acceptability or burden with measures. Forty-eight studies concluded feasibility. The terms "feasibility" and "pilot" are used synonymously in palliative care research when describing studies that test for feasibility. Few studies in palliative care research outline clear criteria for success. The assessment of participant acceptability and burden is uncommon. A gold standard for feasibility study design in palliative care research that includes both clear criteria for success and testing of the study protocol for participant acceptability and burden is needed. Such a standard would assist with consistency in the design, conduct and reporting of feasibility and pilot studies. Copyright © 2017 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

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.

Airline Pilot Cosmic Radiation and Circadian Disruption Exposure Assessment from Logbooks and Company Records

PubMed Central

Grajewski, Barbara; Waters, Martha A.; Yong, Lee C.; Tseng, Chih-Yu; Zivkovich, Zachary; Cassinelli II, Rick T.

2011-01-01

Objectives: US commercial airline pilots, like all flight crew, are at increased risk for specific cancers, but the relation of these outcomes to specific air cabin exposures is unclear. Flight time or block (airborne plus taxi) time often substitutes for assessment of exposure to cosmic radiation. Our objectives were to develop methods to estimate exposures to cosmic radiation and circadian disruption for a study of chromosome aberrations in pilots and to describe workplace exposures for these pilots. Methods: Exposures were estimated for cosmic ionizing radiation and circadian disruption between August 1963 and March 2003 for 83 male pilots from a major US airline. Estimates were based on 523 387 individual flight segments in company records and pilot logbooks as well as summary records of hours flown from other sources. Exposure was estimated by calculation or imputation for all but 0.02% of the individual flight segments’ block time. Exposures were estimated from questionnaire data for a comparison group of 51 male university faculty. Results: Pilots flew a median of 7126 flight segments and 14 959 block hours for 27.8 years. In the final study year, a hypothetical pilot incurred an estimated median effective dose of 1.92 mSv (absorbed dose, 0.85 mGy) from cosmic radiation and crossed 362 time zones. This study pilot was possibly exposed to a moderate or large solar particle event a median of 6 times or once every 3.7 years of work. Work at the study airline and military flying were the two highest sources of pilot exposure for all metrics. An index of work during the standard sleep interval (SSI travel) also suggested potential chronic sleep disturbance in some pilots. For study airline flights, median segment radiation doses, time zones crossed, and SSI travel increased markedly from the 1990s to 2003 (Ptrend < 0.0001). Dose metrics were moderately correlated with records-based duration metrics (Spearman’s r = 0.61–0.69). Conclusions: The methods developed provided an exposure profile of this group of US airline pilots, many of whom have been exposed to increasing cosmic radiation and circadian disruption from the 1990s through 2003. This assessment is likely to decrease exposure misclassification in health studies. PMID:21610083

Airline pilot cosmic radiation and circadian disruption exposure assessment from logbooks and company records.

PubMed

Grajewski, Barbara; Waters, Martha A; Yong, Lee C; Tseng, Chih-Yu; Zivkovich, Zachary; Cassinelli, Rick T

2011-06-01

US commercial airline pilots, like all flight crew, are at increased risk for specific cancers, but the relation of these outcomes to specific air cabin exposures is unclear. Flight time or block (airborne plus taxi) time often substitutes for assessment of exposure to cosmic radiation. Our objectives were to develop methods to estimate exposures to cosmic radiation and circadian disruption for a study of chromosome aberrations in pilots and to describe workplace exposures for these pilots. Exposures were estimated for cosmic ionizing radiation and circadian disruption between August 1963 and March 2003 for 83 male pilots from a major US airline. Estimates were based on 523 387 individual flight segments in company records and pilot logbooks as well as summary records of hours flown from other sources. Exposure was estimated by calculation or imputation for all but 0.02% of the individual flight segments' block time. Exposures were estimated from questionnaire data for a comparison group of 51 male university faculty. Pilots flew a median of 7126 flight segments and 14 959 block hours for 27.8 years. In the final study year, a hypothetical pilot incurred an estimated median effective dose of 1.92 mSv (absorbed dose, 0.85 mGy) from cosmic radiation and crossed 362 time zones. This study pilot was possibly exposed to a moderate or large solar particle event a median of 6 times or once every 3.7 years of work. Work at the study airline and military flying were the two highest sources of pilot exposure for all metrics. An index of work during the standard sleep interval (SSI travel) also suggested potential chronic sleep disturbance in some pilots. For study airline flights, median segment radiation doses, time zones crossed, and SSI travel increased markedly from the 1990s to 2003 (P(trend) < 0.0001). Dose metrics were moderately correlated with records-based duration metrics (Spearman's r = 0.61-0.69). The methods developed provided an exposure profile of this group of US airline pilots, many of whom have been exposed to increasing cosmic radiation and circadian disruption from the 1990s through 2003. This assessment is likely to decrease exposure misclassification in health studies.

Cross-Age Peer Tutors in Asynchronous Discussion Groups: Studying the Impact of Tutors Labelling Their Interventions

ERIC Educational Resources Information Center

De Smet, M.; Van Keer, H.; Valcke, M.

2008-01-01

Cross-age tutors were randomly assigned to one of the three tutor training conditions distinguished for the current study: (1) the labelling experimental condition, characterized by requirements to label their tutor interventions, based on the e-moderating model of Salmon; (2) the non-labelling experimental condition, focusing on tutor's acting…

Mindfulness based cognitive therapy may improve emotional processing in bipolar disorder: pilot ERP and HRV study.

PubMed

Howells, Fleur M; Laurie Rauch, H G; Ives-Deliperi, Victoria L; Horn, Neil R; Stein, Dan J

2014-06-01

Emotional processing in bipolar disorder (BD) is impaired. We aimed to measure the effects of mindfulness based cognitive-behavioral therapy (MBCT) in BD on emotional processing, as measured by event related potentials (ERP) and by heart rate variability (HRV). ERP and HRV were recorded during the completion of a visual matching task, which included object matching, affect matching, and affect labeling. Individuals with BD (n = 12) were compared with controls (n = 9) to obtain baseline data prior to the individuals with BD undergoing an 8-week MBCT intervention. ERP and HRV recording was repeated after the MBCT intervention in BD. Participants with BD had exaggerated ERP N170 amplitude and increased HRV HF peak compared to controls, particularly during the affect matching condition. After an 8-week MBCT intervention, participants with BD showed attenuation of ERP N170 amplitude and reduced HRV HF peak. Our findings support findings from the literature emphasizing that emotional processing in BD is altered, and suggesting that MBCT may improve emotional processing in BD.

Cholinergic Dysfunction in Fragile X Syndrome and Potential Intervention

PubMed Central

Kesler, Shelli R; Lightbody, Amy A; Reiss, Allan L

2009-01-01

Males with fragile X syndrome are at risk for significant cognitive and behavioral deficits, particularly those involving executive prefrontal systems. Disruption of the cholinergic system secondary to fragile X mental retardation protein deficiency may contribute to the cognitive-behavioral impairments associated with fragile X. We measured choline in the dorsolateral prefrontal cortex of 9 males with fragile X syndrome and 9 age-matched typically developing controls using 1H magnetic resonance spectroscopy. Right choline/creatine was significantly reduced in the fragile X group compared to controls. In controls, both left and right choline was significantly positively correlated with intelligence and age was significantly negatively correlated with left choline. There were no correlations in the fragile X group. Subjects with fragile X syndrome participating in a pilot open-label trial of donepezil, an acetylcholinesterase inhibitor, demonstrated significantly improved cognitive-behavioral function. Studies utilizing biochemical neuroimaging techniques such as these have the potential to significantly impact the design of treatment strategies for fragile X syndrome and other genetic disorders by helping identify neurochemical targets for intervention as well as serving as metrics for treatment efficacy. PMID:19215057

Influence of resistant starch on the SCFA production and cell counts of butyrate-producing Eubacterium spp. in the human intestine.

PubMed

Schwiertz, A; Lehmann, U; Jacobasch, G; Blaut, M

2002-01-01

The genus Eubacterium, which is the second most common genus in the human intestine, includes several known butyrate producers. We hypothesized that Eubacterium species play a role in the intestinal butyrate production and are inducible by resistant starch. In a human pilot study species-specific and group-specific 16S rRNA-targeted, Cy3 (indocarbocyanine)-labelled oligonucleotide probes were used to quantify butyrogenic species of the genera Eubacterium, Clostridium and Ruminococcus. Following the intake of RS type III a significant increase in faecal butyrate but not in total SCFA was observed. However, increase in butyrate was not accompanied by a proliferation in the targeted bacteria. The tested Eubacterium species have the capacity to produce butyrate but do not appear to play a major role for butyric acid production in the human intestine. In view of the fact that the bacteria responsible for butyrate production are largely unknown, it is still difficult to devise a dietary intervention to stimulate butyrogenic bacteria in a targeted way.

A novel high resolution, high sensitivity SPECT detector for molecular imaging of cardiovascular diseases

NASA Astrophysics Data System (ADS)

Cusanno, F.; Argentieri, A.; Baiocchi, M.; Colilli, S.; Cisbani, E.; De Vincentis, G.; Fratoni, R.; Garibaldi, F.; Giuliani, F.; Gricia, M.; Lucentini, M.; Magliozzi, M. L.; Majewski, S.; Marano, G.; Musico, P.; Musumeci, M.; Santavenere, F.; Torrioli, S.; Tsui, B. M. W.; Vitelli, L.; Wang, Y.

2010-05-01

Cardiovascular diseases are the most common cause of death in western countries. Understanding the rupture of vulnerable atherosclerotic plaques and monitoring the effect of innovative therapies of heart failure is of fundamental importance. A flexible, high resolution, high sensitivity detector system for molecular imaging with radionuclides on small animal models has been designed for this aim. A prototype has been built using tungsten pinhole and LaBr3(Ce) scintillator coupled to Hamamatsu Flat Panel PMTs. Compact individual-channel readout has been designed, built and tested. Measurements with phantoms as well as pilot studies on mice have been performed, the results show that the myocardial perfusion in mice can be determined with sufficient precision. The detector will be improved replacing the Hamamatsu Flat Panel with Silicon Photomultipliers (SiPMs) to allow integration of the system with MRI scanners. Application of LaBr3(Ce) scintillator coupled to photosensor with high photon detection efficiency and excellent energy resolution will allow dual-label imaging to monitor simultaneously the cardiac perfusion and the molecular targets under investigation during the heart therapy.

Generation of miniaturized planar ecombinant antibody arrays using a microcantilever-based printer

NASA Astrophysics Data System (ADS)

Petersson, Linn; Berthet Duroure, Nathalie; Auger, Angèle; Dexlin-Mellby, Linda; Borrebaeck, Carl AK; Ait Ikhlef, Ali; Wingren, Christer

2014-07-01

Miniaturized (Ø 10 μm), multiplexed (>5-plex), and high-density (>100 000 spots cm-2) antibody arrays will play a key role in generating protein expression profiles in health and disease. However, producing such antibody arrays is challenging, and it is the type and range of available spotters which set the stage. This pilot study explored the use of a novel microspotting tool, BioplumeTM—consisting of an array of micromachined silicon cantilevers with integrated microfluidic channels—to produce miniaturized, multiplexed, and high-density planar recombinant antibody arrays for protein expression profiling which targets crude, directly labelled serum. The results demonstrated that 16-plex recombinant antibody arrays could be produced—based on miniaturized spot features (78.5 um2, Ø 10 μm) at a 7-125-times increased spot density (250 000 spots cm-2), interfaced with a fluorescent-based read-out. This prototype platform was found to display adequate reproducibility (spot-to-spot) and an assay sensitivity in the pM range. The feasibility of the array platform for serum protein profiling was outlined.

Early Maladaptive Schemas in a Sample of Airline Pilots seeking Residential Substance Use Treatment: An Initial Investigation

PubMed Central

Shorey, Ryan C.; Brasfield, Hope; Anderson, Scott; Stuart, Gregory L.

2014-01-01

Background Recent research has begun to examine the early maladaptive schemas of substance abusers, as it is believed that targeting these core beliefs in treatment may result in improved substance use outcomes. One special population that has received scant attention in the research literature, despite high levels of substance use, is airline pilots. Aims The current study examined the early maladaptive schemas of a sample of airline pilots (n = 64) who were seeking residential treatment for alcohol dependence and whether they differed in early maladaptive schemas from non-pilot substance abusers who were also seeking residential treatment for alcohol dependence (n = 45). Method Pre-existing medical records from patients of a residential substance abuse treatment facility were reviewed for the current study. Results Of the 18 early maladaptive schemas, results demonstrated that pilots scored higher than non-pilots on the early maladaptive schema of unrelenting standards (high internalized standards of behavior), whereas non-pilots scored higher on insufficient self-control (low frustration tolerance and self-control). Conclusions Early maladaptive schemas may be a relevant treatment target for substance abuse treatment seeking pilots and non-pilots. PMID:24701252