An Algorithm for Converting Contours to Elevation Grids.

ERIC Educational Resources Information Center

Reid-Green, Keith S.

Some of the test questions for the National Council of Architectural Registration Boards deal with the site, including drainage, regrading, and the like. Some questions are most easily scored by examining contours, but others, such as water flow questions, are best scored from a grid in which each element is assigned its average elevation. This…

Public Perception of the Burden of Microtia.

PubMed

Byun, Stephanie; Hong, Paul; Bezuhly, Michael

2016-10-01

Microtia is associated with psychosocial burden and stigma. The authors' objective was to determine the potential impact of being born with microtia by using validated health state utility assessment measures. An online utility assessment using visual analogue scale, time tradeoff, and standard gamble was used to determine utilities for microtia with or without ipsilateral deafness, monocular blindness, and binocular blindness from a prospective sample of the general population. Utility scores were compared between health states using Wilcoxon and Kruskal-Wallis tests. Univariate regression was performed using sex, age, race, and education as independent predictors of utility scores. Over a 6-month enrollment period, 104 participants were included in the analysis. Visual analogue scale (median 0.80, interquartile range [0.72-0.85]), time tradeoff (0.88 [0.77-0.91]), and standard gamble (0.91 [0.84-0.97]) scores for microtia with ipsilateral deafness were higher (P <0.01) than those of binocular blindness (visual analogue scale, 0.30 [0.20-0.45]; time tradeoff, 0.42 [0.17-0.67]; and standard gamble, 0.52 [0.36-0.78]). Time trade-off scores for microtia with deafness were not different from monocular blindness (0.83 [0.67-0.91]). Higher level of education was associated with higher time tradeoff and standard gamble scores for microtia with or without deafness (P <0.05). Using objective health state utility scores, the current study demonstrates that the perceived burden of microtia with or without deafness is no different or less than monocular blindness. Given high utility scores for microtia, delaying autologous reconstruction beyond school entrance age may be justified.

Quality of life and visual function in Nigeria: findings from the National Survey of Blindness and Visual Impairment.

PubMed

Tran, Hang My; Mahdi, Abdull M; Sivasubramaniam, Selvaraj; Gudlavalleti, Murthy V S; Gilbert, Clare E; Shah, Shaheen P; Ezelum, C C; Abubakar, Tafida; Bankole, Olufunmilayo O

2011-12-01

To assess associations of visual function (VF) and quality of life (QOL) by visual acuity (VA), causes of blindness and types of cataract procedures in Nigeria. Multi-stage stratified cluster random sampling was used to identify a nationally representative sample of persons aged ≥ 40 years. VF/QOL questionnaires were administered to participants with VA <6/60 in one or both eyes and/or Mehra-Minassian cataract grade 2B or 3 in one or both eyes and a random sample of those with bilateral VA ≥ 6/12. VF/QOL questionnaires were administered to 2076 participants. Spearman's rank correlation showed a strong correlation between decreasing VA and VF/QOL scores (p<0.0001) with greatest impact on social (p<0.0001) and mobility-related activities (p<0.0001). People who were blind due to glaucoma had lower VF and QOL scores than those who were blind due to cataract. Mean VF and QOL scores were lower after couching compared with conventional cataract surgery (mean VF score=51.0 vs 63.0 and mean QOL score=71.3 vs 79.3). Finally, VF and QOL scores were lower among populations with specific characteristics. Populations with the following characteristics should be targeted to improve VF and QOL: people who are blind, older people, women, manual labourers, people living in rural areas, those living in the northern geopolitical zones, those practising Islamic and Traditionalism faith, those not currently married and those who have undergone couching.

Continued Validation of the O-SCORE (Ottawa Surgical Competency Operating Room Evaluation): Use in the Simulated Environment.

PubMed

MacEwan, Matthew J; Dudek, Nancy L; Wood, Timothy J; Gofton, Wade T

2016-01-01

CONSTRUCT: The Ottawa Surgical Competency Operating Room Evaluation (O-SCORE) is a 9-item surgical evaluation tool designed to assess technical competence in surgical trainees using behavioral anchors. The initial development of the O-SCORE produced evidence for valid results. Further work is required to determine if the use of a single surgeon or an unblinded rater introduces bias. In addition, the relationship of the O-SCORE to other currently used technical assessment tools should be explored to provide validity evidence related to the relationship to other measures. We have designed this project to provide continued validity evidence for the O-SCORE related to these two issues. Nineteen residents and 2 staff Orthopedic Surgeons from the University of Ottawa volunteered to participate in a 2-part OSCE style station. Participants completed a written questionnaire followed by a videotaped 10-minute simulated open reduction and internal fixation of a midshaft radius fracture. Videos were rated individually by 2 blinded staff orthopedic surgeons using an Objective Structured Assessment of Technical Skills (OSATS) global rating scale, an OSATS checklist, and the O-SCORE in random order. O-SCORE results appeared sensitive to surgical training level even when raters were blinded. In addition, strong agreement between two independent observers using the O-SCORE suggests that the measure captures a performance easily recognized by surgical observers. Ratings on the O-SCORE also were strongly associated with global ratings on the currently most validated technical evaluation tool (OSATS). Collectively, these results suggest that the O-SCORE generates accurate, reproducible, and meaningful results when used in a randomized and blinded fashion, providing continued validity evidence for using this tool to evaluate surgical trainee competence. The O-SCORE was able to differentiate surgical trainee level using blinded raters providing further evidence of validity for the O-SCORE. There was strong agreement between two independent observers using the O-SCORE. Ratings on the O-SCORE also demonstrated equivalence to scores on the most validated technical evaluation tool (OSATS). These results suggest that the O-SCORE demonstrates accurate and reproducible results when used in a randomized and blinded fashion providing continued validity evidence for this tool in the evaluation of surgical competence in the trainees.

Blind image quality assessment without training on human opinion scores

NASA Astrophysics Data System (ADS)

Mittal, Anish; Soundararajan, Rajiv; Muralidhar, Gautam S.; Bovik, Alan C.; Ghosh, Joydeep

2013-03-01

We propose a family of image quality assessment (IQA) models based on natural scene statistics (NSS), that can predict the subjective quality of a distorted image without reference to a corresponding distortionless image, and without any training results on human opinion scores of distorted images. These `completely blind' models compete well with standard non-blind image quality indices in terms of subjective predictive performance when tested on the large publicly available `LIVE' Image Quality database.

Testing the Efficacy of Global Biodiversity Hotspots for Insect Conservation: The Case of South African Katydids.

PubMed

Bazelet, Corinna S; Thompson, Aileen C; Naskrecki, Piotr

2016-01-01

The use of endemism and vascular plants only for biodiversity hotspot delineation has long been contested. Few studies have focused on the efficacy of global biodiversity hotspots for the conservation of insects, an important, abundant, and often ignored component of biodiversity. We aimed to test five alternative diversity measures for hotspot delineation and examine the efficacy of biodiversity hotspots for conserving a non-typical target organism, South African katydids. Using a 1° fishnet grid, we delineated katydid hotspots in two ways: (1) count-based: grid cells in the top 10% of total, endemic, threatened and/or sensitive species richness; vs. (2) score-based: grid cells with a mean value in the top 10% on a scoring system which scored each species on the basis of its IUCN Red List threat status, distribution, mobility and trophic level. We then compared katydid hotspots with each other and with recognized biodiversity hotspots. Grid cells within biodiversity hotspots had significantly higher count-based and score-based diversity than non-hotspot grid cells. There was a significant association between the three types of hotspots. Of the count-based measures, endemic species richness was the best surrogate for the others. However, the score-based measure out-performed all count-based diversity measures. Species richness was the least successful surrogate of all. The strong performance of the score-based method for hotspot prediction emphasizes the importance of including species' natural history information for conservation decision-making, and is easily adaptable to other organisms. Furthermore, these results add empirical support for the efficacy of biodiversity hotspots in conserving non-target organisms.

Testing the Efficacy of Global Biodiversity Hotspots for Insect Conservation: The Case of South African Katydids

PubMed Central

Bazelet, Corinna S.; Thompson, Aileen C.; Naskrecki, Piotr

2016-01-01

The use of endemism and vascular plants only for biodiversity hotspot delineation has long been contested. Few studies have focused on the efficacy of global biodiversity hotspots for the conservation of insects, an important, abundant, and often ignored component of biodiversity. We aimed to test five alternative diversity measures for hotspot delineation and examine the efficacy of biodiversity hotspots for conserving a non-typical target organism, South African katydids. Using a 1° fishnet grid, we delineated katydid hotspots in two ways: (1) count-based: grid cells in the top 10% of total, endemic, threatened and/or sensitive species richness; vs. (2) score-based: grid cells with a mean value in the top 10% on a scoring system which scored each species on the basis of its IUCN Red List threat status, distribution, mobility and trophic level. We then compared katydid hotspots with each other and with recognized biodiversity hotspots. Grid cells within biodiversity hotspots had significantly higher count-based and score-based diversity than non-hotspot grid cells. There was a significant association between the three types of hotspots. Of the count-based measures, endemic species richness was the best surrogate for the others. However, the score-based measure out-performed all count-based diversity measures. Species richness was the least successful surrogate of all. The strong performance of the score-based method for hotspot prediction emphasizes the importance of including species’ natural history information for conservation decision-making, and is easily adaptable to other organisms. Furthermore, these results add empirical support for the efficacy of biodiversity hotspots in conserving non-target organisms. PMID:27631131

Demonstration Report: Handheld UXO Discriminator, SERDP No. MR-1667

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

Gasperikova, E.

2010-09-01

In 2003, the Defense Science Board observed: 'The problem is that instruments that can detect the buried UXOs also detect numerous scrap metal objects and other artifacts, which leads to an enormous amount of expensive digging. Typically 100 holes may be dug before a real UXO is unearthed! The Task Force assessment is that much of this wasteful digging can be eliminated by the use of more advanced technology instruments that exploit modern digital processing and advanced multi-mode sensors to achieve an improved level of discrimination of scrap from UXOs.' In keeping with these remarks and with prior funding (UX-1225,more » MM-0437, and MM-0838), the LBNL group has successfully designed and built the cart-mounted Berkeley UXO Discriminator (BUD) and demonstrated its performance at various test sites (cf. Gasperikova et al., 2007, 2008, and 2009). Because hand-held systems have the advantage of being lightweight, compact, portable, and deployable under most site conditions, they are particularly useful in areas of dense vegetation or challenging terrain. In heavily wooded areas or areas with steep or uneven terrain, hand-held sensors may be the only suitable device for UXO detection and discrimination because it can be carried through spaces that the operator could walk through or at least approach. Furthermore, it is desirable to find and characterize a metallic object without the need to accurately locate the sensors at multiple positions around the target. The ideal system would thus locate and characterize the target from a single position of the sensor and indicate to the operator where to flag the target for subsequent study. Based on these considerations, we designed and built a sensor package in a shape of a 14-in (0.35 m) cube. This hand-held prototype incorporates the key features of the cart-mounted system - (a) three orthogonal transmitters and ten pairs of receivers, and (b) difference or gradient measurements that significantly reduce the ambient and motion noise, and greatly enhance the sensitivity to the gradients of the target. The system characterizes the target from a single position. Results from a local test site were in a good agreement with theoretical performance calculations of such a device. This survey was designed to demonstrate performance of the system under realistic survey conditions at the Aberdeen Proving Ground (APG) in Aberdeen, MD. The survey was preformed in an area with known items ('Calibration Grid'), and in a seeded blind test area (the 'Blind Test Grid'). The ground truth for the surveys conducted on the Blind Test Grid was withheld from the testers. Only the graded test scores based on target detection and target classification were provided. For more information, see http://aec.army.mil/usaec/technology/uxo01c03.html.« less

Grid-based Molecular Footprint Comparison Method for Docking and De Novo Design: Application to HIVgp41

PubMed Central

Mukherjee, Sudipto; Rizzo, Robert C.

2014-01-01

Scoring functions are a critically important component of computer-aided screening methods for the identification of lead compounds during early stages of drug discovery. Here, we present a new multi-grid implementation of the footprint similarity (FPS) scoring function that was recently developed in our laboratory which has proven useful for identification of compounds which bind to a protein on a per-residue basis in a way that resembles a known reference. The grid-based FPS method is much faster than its Cartesian-space counterpart which makes it computationally tractable for on-the-fly docking, virtual screening, or de novo design. In this work, we establish that: (i) relatively few grids can be used to accurately approximate Cartesian space footprint similarity, (ii) the method yields improved success over the standard DOCK energy function for pose identification across a large test set of experimental co-crystal structures, for crossdocking, and for database enrichment, and (iii) grid-based FPS scoring can be used to tailor construction of new molecules to have specific properties, as demonstrated in a series of test cases targeting the viral protein HIVgp41. The method will be made available in the program DOCK6. PMID:23436713

Performance of Blind Children on Digit-Span Tests.

ERIC Educational Resources Information Center

Hull, T.; Mason, H.

1995-01-01

This article reports the results of digit-span tests administered to 314 children who were visually impaired. Results found that gender, first language, and educational setting had no effect on the children's scores and that the congenitally totally blind children scored higher than did sighted children, whereas those who had had some sight did…

The Impact of Clinical Information on the Assessment of Endoscopic Activity: Characteristics of the Ulcerative Colitis Endoscopic Index Of Severity [UCEIS].

PubMed

Travis, Simon P L; Schnell, Dan; Feagan, Brian G; Abreu, Maria T; Altman, Douglas G; Hanauer, Stephen B; Krzeski, Piotr; Lichtenstein, Gary R; Marteau, Philippe R; Mary, Jean-Yves; Reinisch, Walter; Sands, Bruce E; Schnell, Patrick; Yacyshyn, Bruce R; Colombel, Jean-Frédéric; Bernhardt, Christian A; Sandborn, William J

2015-08-01

To determine whether clinical information influences endoscopic scoring by central readers using the Ulcerative Colitis Endoscopic Index of Severity [UCEIS; comprising 'vascular pattern', 'bleeding', 'erosions and ulcers']. Forty central readers performed 28 evaluations, including 2 repeats, from a library of 44 video sigmoidoscopies stratified by Mayo Clinic Score. Following training, readers were randomised to scoring with ['unblinded', n = 20, including 4 control videos with misleading information] or without ['blinded', n 20] clinical information. A total of 21 virtual Central Reader Groups [CRGs], of three blinded readers, were created. Agreement criteria were pre-specified. Kappa [κ] statistics quantified intra- and inter-reader variability. Mean UCEIS scores did not differ between blinded and unblinded readers for any of the 40 main videos. UCEIS standard deviations [SD] were similar [median blinded 0.94, unblinded 0.93; p = 0.97]. Correlation between UCEIS and visual analogue scale [VAS] assessment of overall severity was high [r blinded = 0.90, unblinded = 0.93; p = 0.02]. Scores for control videos were similar [UCEIS: p ≥ 0.55; VAS: p ≥ 0.07]. Intra- [κ 0.47-0.74] and inter-reader [κ 0.40-0.53] variability for items and full UCEIS was 'moderate'-to-'substantial', with no significant differences except for intra-reader variability for erosions and ulcers [κ blinded: 0.47 vs unblinded: 0.74; p 0.047]. The SD of CRGs was lower than for individual central readers [0.54 vs 0.95; p < 0.001]. Correlation between blinded UCEIS and patient-reported symptoms was high [stool frequency: 0.76; rectal bleeding: 0.82; both: 0.81]. The UCEIS is minimally affected by knowledge of clinical details, strongly correlates with patient-reported symptoms, and is a suitable instrument for trials. CRGs performed better than individuals. © European Crohn’s and Colitis Organisation 2015.

The influence of MCAT and GPA preadmission academic metrics on interview scores.

PubMed

Gay, Steven E; Santen, Sally A; Mangrulkar, Rajesh S; Sisson, Thomas H; Ross, Paula T; Zaidi, Nikki L Bibler

2018-03-01

Medical school admissions interviews are used to assess applicants' nonacademic characteristics as advocated by the Association of American Medical Colleges' Advancing Holistic Review Initiative. The objective of this study is to determine whether academic metrics continue to significantly influence interviewers' scores in holistic processes by blinding interviewers to applicants' undergraduate grade point averages (uGPA) and Medical College Admission Test (MCAT). This study examines academic and demographic predictors of interview scores for two applicant cohorts at the University of Michigan Medical School. In 2012, interviewers were provided applicants' uGPA and MCAT scores; in 2013, these academic metrics were withheld from interviewers' files. Hierarchical regression analysis was conducted to examine the influence of academic and demographic variables on overall cohort interview scores. When interviewers were provided uGPA and MCAT scores, academic metrics explained more variation in interview scores (7.9%) than when interviewers were blinded to these metrics (4.1%). Further analysis showed a statistically significant interaction between cohort and uGPA, indicating that the association between uGPA and interview scores was significantly stronger for the 2012 unblinded cohort compared to the 2013 blinded cohort (β = .573, P < .05). By contrast, MCAT scores had no interactive effects on interviewer scores. While MCAT scores accounted for some variation in interview scores for both cohorts, only access to uGPA significantly influenced interviewers' scores when looking at interaction effects. Withholding academic metrics from interviewers' files may promote assessment of nonacademic characteristics independently from academic metrics.

Comparison of Arthroscopically Guided Suprascapular Nerve Block and Blinded Axillary Nerve Block vs. Blinded Suprascapular Nerve Block in Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial.

PubMed

Ko, Sang Hun; Cho, Sung Do; Lee, Chae Chil; Choi, Jang Kyu; Kim, Han Wook; Park, Seon Jae; Bae, Mun Hee; Cha, Jae Ryong

2017-09-01

The purpose of this study was to compare the results of arthroscopically guided suprascapular nerve block (SSNB) and blinded axillary nerve block with those of blinded SSNB in terms of postoperative pain and satisfaction within the first 48 hours after arthroscopic rotator cuff repair. Forty patients who underwent arthroscopic rotator cuff repair for medium-sized full thickness rotator cuff tears were included in this study. Among them, 20 patients were randomly assigned to group 1 and preemptively underwent blinded SSNB and axillary nerve block of 10 mL 0.25% ropivacaine and received arthroscopically guided SSNB with 10 mL of 0.25% ropivacaine. The other 20 patients were assigned to group 2 and received blinded SSNB with 10 mL of 0.25% ropivacaine. Visual analog scale (VAS) score for pain and patient satisfaction score were assessed 4, 8, 12, 24, 36, and 48 hours postoperatively. The mean VAS score for pain was significantly lower 4, 8, 12, 24, 36, and 48 hours postoperatively in group 1 (group 1 vs. group 2; 5.2 vs. 7.4, 4.1 vs. 6.1, 3.0 vs. 5.1, 2.1 vs. 4.2, 0.9 vs. 3.9, and 1.3 vs. 3.3, respectively). The mean patient satisfaction score was significantly higher at postoperative 4, 8, 12, 24, 36, and 48 hours in group 1 (group 1 vs. group 2; 6.7 vs. 3.9, 7.4 vs. 5.1, 8.8 vs. 5.9, 9.2 vs. 6.7, 9.5 vs. 6.9, and 9.0 vs. 7.2, respectively). Arthroscopically guided SSNB and blinded axillary nerve block in arthroscopic rotator cuff repair for medium-sized rotator cuff tears provided more improvement in VAS for pain and greater patient satisfaction in the first 48 postoperative hours than blinded SSNB.

Change-readiness of the blind: a hospital based study in a coastal town of South India.

PubMed

Shetty, Ramya; Kulkarni, Uma D

2014-01-01

Blindness is a devastating condition with psychosocial and economic effects. The shortcomings result in a burden to the blind person, the family and society. Rehabilitation of the blind can transform their lives. The aim of this study was to assess the "change-readiness" of the blind to undergo a "change-management". The study was a semi-structured pre-tested questionnaire-based study of 50 blind subjects in a medical college hospital. The blind participants were assessed for depression using the Beck Depression Inventory II, for the perceived effect of blindness on family, social life and occupation. The participants were counseled to undergo psychiatric management, vocational training, use blind aids and learn Braille. The willingness of the participants with reasons was assessed using a verbal analogue scale. Pearson Chi-square test, ANOVA and the t-test were used for statistical analysis. Over two-thirds of the subjects were depressed. Family life, social life and occupation were perceived to be affected by 44%, 66% and 74%, respectively. Change-readiness scores were low for low vision and blind aids, vocational training, psychiatric management, change of job and learning Braille. The low score was due to the associated taboo, dependence, lack of skills, embarrassment, etc., The most valuable feature was the family cohesiveness. The results suggest that there is a need to modify health policy to include blind rehabilitation, to improve visibility of blind rehabilitation centers, to include family members and co-professionals while managing the blind so that we treat the "blind person" and not a "pair of blind eyes".

A grid for a precise analysis of daily activities.

PubMed

Wojtasik, V; Olivier, C; Lekeu, F; Quittre, A; Adam, S; Salmon, E

2010-01-01

Assessment of daily living activities is essential in patients with Alzheimer's disease. Most current tools quantitatively assess overall ability but provide little qualitative information on individual difficulties. Only a few tools allow therapists to evaluate stereotyped activities and record different types of errors. We capitalised on the Kitchen Activity Assessment to design a widely applicable analysis grid that provides both qualitative and quantitative data on activity performance. A cooking activity was videotaped in 15 patients with dementia and assessed according to the different steps in the execution of the task. The evaluations obtained with our grid showed good correlations between raters, between versions of the grid and between sessions. Moreover, the degree of independence obtained with our analysis of the task correlated with the Kitchen Activity Assessment score and with a global score of cognitive functioning. We conclude that assessment of a daily living activity with this analysis grid is reproducible and relatively independent of the therapist, and thus provides quantitative and qualitative information useful for both evaluating and caring for demented patients.

Novel grid-based optical Braille conversion: from scanning to wording

NASA Astrophysics Data System (ADS)

Yoosefi Babadi, Majid; Jafari, Shahram

2011-12-01

Grid-based optical Braille conversion (GOBCO) is explained in this article. The grid-fitting technique involves processing scanned images taken from old hard-copy Braille manuscripts, recognising and converting them into English ASCII text documents inside a computer. The resulted words are verified using the relevant dictionary to provide the final output. The algorithms employed in this article can be easily modified to be implemented on other visual pattern recognition systems and text extraction applications. This technique has several advantages including: simplicity of the algorithm, high speed of execution, ability to help visually impaired persons and blind people to work with fax machines and the like, and the ability to help sighted people with no prior knowledge of Braille to understand hard-copy Braille manuscripts.

Front blind spot crashes in Hong Kong.

PubMed

Cheng, Yuk Ki; Wong, Koon Hung; Tao, Chi Hang; Tam, Cheok Ning; Tam, Yiu Yan; Tsang, Cheuk Nam

2016-09-01

In 2012-2014, our laboratory had investigated a total of 9 suspected front blind spot crashes, in which the medium and heavy goods vehicles pulled away from rest and rolled over the pedestrians, who were crossing immediately in front of the vehicles. The drivers alleged that they did not see any pedestrians through the windscreens or the front blind spot mirrors. Forensic assessment of the goods vehicles revealed the existence of front blind spot zones in 3 out of these 9 accident vehicles, which were attributed to the poor mirror adjustments or even the absence of a front blind spot mirror altogether. In view of this, a small survey was devised involving 20 randomly selected volunteers and their goods vehicles and 5 out of these vehicles had blind spots at the front. Additionally, a short questionnaire was conducted on these 20 professional lorry drivers and it was shown that most of them were not aware of the hazards of blind spots immediately in front of their vehicles, and many did not use the front blind spot mirrors properly. A simple procedure for quick measurements of the coverage of front blind spot mirrors using a coloured plastic mat with dimensional grids was also introduced and described in this paper. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Using the Bem and Klein Grid Scores to Predict Health Services Usage by Men

PubMed Central

Reynolds, Grace L.; Fisher, Dennis G.; Dyo, Melissa; Huckabay, Loucine M.

2016-01-01

We examined the association between scores on the Bem Sex Roles Inventory (BSRI), Klein Sexual Orientation Grid (KSOG) and utilization of hospital inpatient services, emergency departments, and outpatient clinic visits in the past 12 months among 53 men (mean age 39 years). The femininity subscale score on the BSRI, ever having had gonorrhea and age were the three variables identified in a multivariate linear regression significantly predicting use of total health services. This supports the hypothesis that sex roles can assist our understanding of men’s use of health services. PMID:27337618

Double-blind evaluation of deanol in tardive dyskinesia.

PubMed

Penovich, P; Morgan, J P; Kerzner, B; Karch, F; Goldblatt, D

1978-05-12

We administered deanol acetamidobenzoate, 2.0 g/day for four weeks, a double-blind, placebo-controlled crossover trial, to 14 patients with tardive dyskineasia. The patient population included both inpatients and outpatients. The response was evaluated by subjective clinical impression and scoring of filmed sequences. Patients' conditions improved significantly from baseline scores while receiving both deanol and placebo, but there was no distinction between the two treatments.

Novel pyrrolopyridinone derivatives as anticancer inhibitors towards Cdc7: QSAR studies based on dockings by solvation score approach.

PubMed

Wu, Xiangxiang; Zeng, Huahui; Zhu, Xin; Ma, Qiujuan; Hou, Yimin; Wu, Xuefen

2013-11-20

A series of pyrrolopyridinone derivatives as specific inhibitors towards the cell division cycle 7 (Cdc7) was taken into account, and the efficacy of these compounds was analyzed by QSAR and docking approaches to gain deeper insights into the interaction mechanism and ligands selectivity for Cdc7. By regression analysis the prediction models based on Grid score and Zou-GB/SA score were found, respectively with good quality of fits (r(2)=0.748, 0.951; r(cv)(2)=0.712, 0.839). The accuracy of the models was validated by test set and the deviation of the predicted values in validation set using Zou-GB/SA score was smaller than that using Grid score, suggesting that the model based on Zou-GB/SA score provides a more effective method for predicting potencies of Cdc7 inhibitors. Copyright © 2013 Elsevier B.V. All rights reserved.

Assessing Option Grid® practicability and feasibility for facilitating shared decision making: An exploratory study.

PubMed

Tsulukidze, Maka; Grande, Stuart W; Gionfriddo, Michael R

2015-07-01

To assess the feasibility of Option Grids(®)for facilitating shared decision making (SDM) in simulated clinical consultations and explore clinicians' views on their practicability. We used mixed methods approach to analyze clinical consultations using the Observer OPTION instrument and thematic analysis for follow-up interviews with clinicians. Clinicians achieved high scores on information sharing and low scores on preference elicitation and integration. Four themes were identified: (1) Barriers affect practicability of Option Grids(®); (2) Option Grids(®) facilitate the SDM process; (3) Clinicians are aware of the gaps in their practice of SDM; (4) Training and ongoing feedback on the optimal use of Option Grids(®) are necessary. Use of Option Grids(®) by clinicians with background knowledge in SDM did not facilitate optimal levels of competency on the SDM core concepts of preference elicitation and integration. Future research must evaluate the impact of training on the use of Option Grids(®), and explore how best to help clinicians bridge the gap between knowledge and action. Clinicians proficiently imparting information in simulations struggled to elicit and integrate patient preferences - understanding this gap and developing strategies to close it are the next steps for implementing SDM into clinical practice. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Change-Readiness of the Blind: A Hospital Based Study in a Coastal Town of South India

PubMed Central

Shetty, Ramya; Kulkarni, Uma D.

2014-01-01

Purpose: Blindness is a devastating condition with psychosocial and economic effects. The shortcomings result in a burden to the blind person, the family and society. Rehabilitation of the blind can transform their lives. The aim of this study was to assess the “change-readiness” of the blind to undergo a “change-management”. Materials and Methods: The study was a semi-structured pre-tested questionnaire-based study of 50 blind subjects in a medical college hospital. The blind participants were assessed for depression using the Beck Depression Inventory II, for the perceived effect of blindness on family, social life and occupation. The participants were counseled to undergo psychiatric management, vocational training, use blind aids and learn Braille. The willingness of the participants with reasons was assessed using a verbal analogue scale. Pearson Chi-square test, ANOVA and the t-test were used for statistical analysis. Results: Over two-thirds of the subjects were depressed. Family life, social life and occupation were perceived to be affected by 44%, 66% and 74%, respectively. Change-readiness scores were low for low vision and blind aids, vocational training, psychiatric management, change of job and learning Braille. The low score was due to the associated taboo, dependence, lack of skills, embarrassment, etc., The most valuable feature was the family cohesiveness. Conclusion: The results suggest that there is a need to modify health policy to include blind rehabilitation, to improve visibility of blind rehabilitation centers, to include family members and co-professionals while managing the blind so that we treat the “blind person” and not a “pair of blind eyes”. PMID:24791108

Optimizing Clinical Drug Product Performance: Applying Biopharmaceutics Risk Assessment Roadmap (BioRAM) and the BioRAM Scoring Grid.

PubMed

Dickinson, Paul A; Kesisoglou, Filippos; Flanagan, Talia; Martinez, Marilyn N; Mistry, Hitesh B; Crison, John R; Polli, James E; Cruañes, Maria T; Serajuddin, Abu T M; Müllertz, Anette; Cook, Jack A; Selen, Arzu

2016-11-01

The aim of Biopharmaceutics Risk Assessment Roadmap (BioRAM) and the BioRAM Scoring Grid is to facilitate optimization of clinical performance of drug products. BioRAM strategy relies on therapy-driven drug delivery and follows an integrated systems approach for formulating and addressing critical questions and decision-making (J Pharm Sci. 2014,103(11): 3777-97). In BioRAM, risk is defined as not achieving the intended in vivo drug product performance, and success is assessed by time to decision-making and action. Emphasis on time to decision-making and time to action highlights the value of well-formulated critical questions and well-designed and conducted integrated studies. This commentary describes and illustrates application of the BioRAM Scoring Grid, a companion to the BioRAM strategy, which guides implementation of such an integrated strategy encompassing 12 critical areas and 6 assessment stages. Application of the BioRAM Scoring Grid is illustrated using published literature. Organizational considerations for implementing BioRAM strategy, including the interactions, function, and skillsets of the BioRAM group members, are also reviewed. As a creative and innovative systems approach, we believe that BioRAM is going to have a broad-reaching impact, influencing drug development and leading to unique collaborations influencing how we learn, and leverage and share knowledge. Published by Elsevier Inc.

[The study of establishment of the " Chinese provincial Blindness prevention technical guidance group performance evaluation system"].

PubMed

Lu, L N; He, X G; Zhu, J F; Xu, X; Zhang, R; Hu, X; Zou, H D

2016-11-11

Objective: To establish an assessment system, including indexes and scoring methods, that can be used for performance evaluation of the provincial blindness prevention technical guidance group properly and effectively . Methods: The indexes and scoring methods were set based on the core content of The " National Plan of Prevention and Treatment of Blindness (2012-2015)" , the specific requirement and target of the World Health Organization (WHO) "For the General Eye Health: Global plan of Action (2014-2019)" , and the current situation of the China's provinces and autonomous regions. These indexes should be of effectiveness, feasibility, comparability, guidance and advancing. Formed by a literature review of candidate indicators, the framework of the system is built by qualitative assessment. With the Delphi method, the system was further revised and improved. Empirical pilot study was then used to prove the feasibility, followed by the final qualitative analysis that establish the " Chinese provincial Blindness prevention technical guidance group performance evaluation system" . Results: Through the literature review and qualitative assessment, a six dimensional system framework was built, including 6 first-level indicators, 16 second-level indicators, and 29 third-level indicators through Delphi method evaluation. With the variation coefficient method, the coeffiences of the first-level index weight were calculated as: Organization and management 0.15, Development and implementation of blindness prevention plans 0.15, Implementation of blindness prevention projects 0.14, Training 0.17, Health education 0.18, and Cooperation and exchanges 0.21. The specific scoring method for this system is confirmed as: data and files check, field interview, and record interview, sampling investigation. Empirical pilot study was conducted in the Jilin, Guizhou and Gansu provinces, and the self-assessment results from local experts were consistent with the scores from the systems. Conclusion: This system established is appropriate at current time, and it can effectively evaluate the performance of the Chinese provincial Blindness prevention technical guidance group. (Chin J Ophthalmol, 2016, 52:814-824) .

Standardized UXO Technology Demonstration Site Blind Grid Record No. 904 (Sky Research, Inc.). EM61 MKII/Towed Array

DTIC Science & Technology

2008-09-01

DEMONSTRATOR’S FIELD PERSONNEL Geophysicist: Craig Hyslop Geophysicist: John Jacobsen Geophysicist: Rob Mehl 3.7 DEMONSTRATOR’S FIELD SURVEYING...Yuma Proving Ground Soil Survey Report, May 2003. 5. Practical Nonparametric Statistics, W.J. Conover, John Wiley & Sons, 1980 , pages 144 through

Standardized Analysis for UXO Demonstration Sites

DTIC Science & Technology

2008-04-01

is a time-domain electromagnetic instrument designed to detect shallow ferrous and nonferrous metallic objects. The applicability of the EM61 for UXO...or spots show EMI field anomalies caused by buried metal objects, both UXO and clutter. Anomaly maps for APG are shown in Figure 5. The Blind Grid

Short-term outcomes of local infiltration anaesthetic in total knee arthroplasty: a randomized controlled double-blinded controlled trial.

PubMed

Mulford, Jonathan S; Watson, Anna; Broe, David; Solomon, Michael; Loefler, Andreas; Harris, Ian

2016-03-01

The primary objective of the study was to determine if local infiltration anaesthetic (LIA) reduced total length of hospital stay in total knee arthroplasty (TKA) patients. The study also examined whether LIA improves early pain management, patient satisfaction and range of motion in TKA patients. We conducted a randomized controlled double-blinded study. Fifty patients undergoing TKA were randomized to receive either placebo or LIA at the time of surgery and on the first day post-operatively. Pain scores, level of satisfaction and range of motion were recorded preoperatively and post-operatively. There was no statistical difference between the groups for length of stay, post-operative pain scores, satisfaction scores or range of motion 6 weeks post-operatively. This randomized double-blinded trial did not demonstrate a decrease in pain or reduction of length of stay due to local infiltration analgesia. © 2015 Royal Australasian College of Surgeons.

A double-blind, placebo-controlled study of edivoxetine as an adjunctive treatment for patients with major depressive disorder who are partial responders to selective serotonin reuptake inhibitor treatment.

PubMed

Ball, Susan; Dellva, Mary Anne; D'Souza, Deborah N; Marangell, Lauren B; Russell, James M; Goldberger, Celine

2014-01-01

This phase 2 study examined the efficacy and tolerability of edivoxetine, a highly selective norepinephrine reuptake inhibitor, as an adjunctive treatment for patients with major depressive disorder (MDD) who have a partial response to selective serotonin reuptake inhibitor (SSRI) treatment. Study design consisted of double-blind, 10-week therapy of adjunctive edivoxetine (6-18 mg once daily) or adjunctive placebo with SSRI. Inclusion/entry criteria included partial response to current SSRI by investigator opinion and a GRID 17-item Hamilton Rating Scale for Depression (HAMD17) total score ≥16. The primary efficacy measure was the Montgomery-Asberg Depression Rating Scale (MADRS). Safety measures included treatment-emergent adverse events (TEAE) and vital signs. For the primary evaluable population (n=63 for adjunctive edivoxetine and n=68 for adjunctive placebo), the treatment groups did not differ significantly on the primary outcome of change from baseline to week 8 in the MADRS total score; the effect size of edivoxetine treatment was 0.26. Significant treatment differences, favoring adjunctive edivoxetine (p≤.05), were shown for improvements in role functioning and the functional impact of fatigue. For the adjunctive edivoxetine randomized group (N=111), the most frequent TEAEs were hyperhidrosis (7.2%), nausea (7.2%), erectile dysfunction (6.3%) and testicular pain (6.3%). Hemodynamic changes were observed in blood pressure and pulse rate between treatment groups. Study was underpowered for an alpha 2-sided 0.05 significance level for the primary outcome. For patients with MDD who had a partial response to SSRIs, adjunctive edivoxetine treatment was not statistically superior to adjunctive placebo on the primary outcome measure. However, pending further study, improved functioning and remission rate suggest a potential role for edivoxetine for patients with depression. Copyright © 2014 Elsevier B.V. All rights reserved.

The effectiveness of dental health education tools for visually impaired students in Bukit Mertajam

NASA Astrophysics Data System (ADS)

Shahabudin, Saadiah; Hashim, Hasnah; Omar, Maizurah

2016-12-01

Oral health is a vital component of overall health. It is important in adults and children alike, however, it is even more crucial for children with special needs as they have limited ability to perform oral health practices. Disabled children deserve the same opportunity for oral health as normal children. Unfortunately, oral health care is the most unattended health needs of the disabled children. This study aimed to assess the effectiveness of dental health education tools for visually impaired students in two schools in Bukit Mertajam, Penang. The project utilized dental health education tools consisting of an oral health module (printed in braille for the blind and in font 18px for the partially blind), an audio narration of the module were prepared and content-validated by an expert panel. Baseline plaque scores of 38 subjects aged 6-17 years were determined by a trained dental staff nurse. The module was then administered to the subjects facilitated by the teachers. Post intervention plaque scores were recorded again after one month. The pre and post intervention data were analyzed using Wilcoxon Signed Ranks Test with a significant p value set at < 0.05. The results showed that there was a reduction in the overall median plaque score in both partially blind (n = 22) and totally blind (n = 16) subjects (2.2 (IQR 0.7) to 1.8 (IQR 0.5) and 2.1 (IQR 0.4) to 2.0 0 (IQR 0.7) respectively). The score difference in the totally blind group was significant (p=0.025). Reductions in plaque scores were also observed in stratified data (based on age); with the partially blind aged 12-17 years showing the greatest reduction. However, the difference was not statistically significant (p=0.067). At younger age, tooth brushing should be supervised by parents as their manual dexterity and cognitive ability is still low. In addition, the younger subjects are less motivated if compared to the older ones. These factors could affect the result of the overall mean OHI-score in this study. In conclusion, the tools appeared to have a positive effect on promoting good oral hygiene among students with visual impairment. We recommend for further studies to be conducted on a bigger sample.

Stealthy false data injection attacks using matrix recovery and independent component analysis in smart grid

NASA Astrophysics Data System (ADS)

JiWei, Tian; BuHong, Wang; FuTe, Shang; Shuaiqi, Liu

2017-05-01

Exact state estimation is vital important to maintain common operations of smart grids. Existing researches demonstrate that state estimation output could be compromised by malicious attacks. However, to construct the attack vectors, a usual presumption in most works is that the attacker has perfect information regarding the topology and so on even such information is difficult to acquire in practice. Recent research shows that Independent Component Analysis (ICA) can be used for inferring topology information which can be used to originate undetectable attacks and even to alter the price of electricity for the profits of attackers. However, we found that the above ICA-based blind attack tactics is merely feasible in the environment with Gaussian noises. If there are outliers (device malfunction and communication errors), the Bad Data Detector will easily detect the attack. Hence, we propose a robust ICA based blind attack strategy that one can use matrix recovery to circumvent the outlier problem and construct stealthy attack vectors. The proposed attack strategies are tested with IEEE representative 14-bus system. Simulations verify the feasibility of the proposed method.

Comparison of aloe vera mouthwash with triamcinolone acetonide 0.1% on oral lichen planus: a randomized double-blinded clinical trial.

PubMed

Mansourian, Arash; Momen-Heravi, Fatemeh; Saheb-Jamee, Mahnaz; Esfehani, Mahsa; Khalilzadeh, Omid; Momen-Beitollahi, Jalil

2011-12-01

Corticosteroids are the mainstay for treatment of oral lichen planus (OLP) and have their own side effects. The aim of this study was to compare the therapeutic effects of aloe vera (AV) mouthwash with triamcinolone acetonide 0.1% (TA) on OLP. A total of 46 patients with OLP were enrolled in this study. The patients were randomly divided into 2 groups. Each group was treated with received AV mouthwash or TA. The treatment period for both groups was 4 weeks. The basement data were recorded for each patient. Patients were evaluated on days 8, 16 and after completing the course of treatment (visit 1-3). The last follow-up was 2 months after the start of treatment (visit 4). Visual analogue scale was used for evaluating pain and burning sensation and Thongprasom index for clinical improvement and healing. In addition, lesion sizes were measured and recorded at each visit using a grid. Baseline characteristics, including pain and burning sensation score, size and clinical characteristics of the lesions according to Thongprasom index, were not different between the 2 treatment groups. Both AV and TA significantly reduced visual analogue scale score, Thongprasom score and size of the lesions after treatment (P < 0.001) and after 2 months of discontinuation of the treatment (P < 0.001). In the AV group, 74% of patients and in the TA group 78% of patients showed some degrees of healing in the last follow-up. AV mouthwash is an effective substitute for TA in the treatment of OLP.

Learning Receptive Fields and Quality Lookups for Blind Quality Assessment of Stereoscopic Images.

PubMed

Shao, Feng; Lin, Weisi; Wang, Shanshan; Jiang, Gangyi; Yu, Mei; Dai, Qionghai

2016-03-01

Blind quality assessment of 3D images encounters more new challenges than its 2D counterparts. In this paper, we propose a blind quality assessment for stereoscopic images by learning the characteristics of receptive fields (RFs) from perspective of dictionary learning, and constructing quality lookups to replace human opinion scores without performance loss. The important feature of the proposed method is that we do not need a large set of samples of distorted stereoscopic images and the corresponding human opinion scores to learn a regression model. To be more specific, in the training phase, we learn local RFs (LRFs) and global RFs (GRFs) from the reference and distorted stereoscopic images, respectively, and construct their corresponding local quality lookups (LQLs) and global quality lookups (GQLs). In the testing phase, blind quality pooling can be easily achieved by searching optimal GRF and LRF indexes from the learnt LQLs and GQLs, and the quality score is obtained by combining the LRF and GRF indexes together. Experimental results on three publicly 3D image quality assessment databases demonstrate that in comparison with the existing methods, the devised algorithm achieves high consistent alignment with subjective assessment.

Are Boys Discriminated in Swedish High Schools?

ERIC Educational Resources Information Center

Hinnerich, Bjorn Tyrefors; Hoglin, Erik; Johannesson, Magnus

2011-01-01

Girls typically have higher grades than boys in school and recent research suggests that part of this gender difference may be due to discrimination of boys in grading. We rigorously test this in a field experiment where a random sample of the same tests in the Swedish language is subject to blind and non-blind grading. The non-blind test score is…

Discrimination against Students with Foreign Backgrounds: Evidence from Grading in Swedish Public High Schools

ERIC Educational Resources Information Center

Hinnerich, Bjorn Tyrefors; Höglin, Erik; Johannesson, Magnus

2015-01-01

We rigorously test for discrimination against students with foreign backgrounds in high school grading in Sweden. We analyse a random sample of national tests in the Swedish language graded both non-blindly by the student's own teacher and blindly without any identifying information. The increase in the test score due to non-blind grading is…

Better early functional outcome after short stem total hip arthroplasty? A prospective blinded randomised controlled multicentre trial comparing the Collum Femoris Preserving stem with a Zweymuller straight cementless stem total hip replacement for the treatment of primary osteoarthritis of the hip

PubMed Central

van Oldenrijk, Jakob; Scholtes, Vanessa A B; van Beers, Loes W A H; Geerdink, Carel H; Niers, Bob B A M; Runne, Wouter; Bhandari, Mohit; Poolman, Rudolf W

2017-01-01

Objectives Primary aim was to compare the functional results at 3 months and 2 years between short and conventional cementless stem total hip arthroplasty (THA). Secondary aim was to determine the feasibility of a double-blind implant-related trial. Design A prospective blinded randomised controlled multicentre trial in patients with osteoarthritis of the hip. All patients, research assistants, clinical assessors, investigators and data analysts were blinded to the type of prosthesis. Population: 150 patients between 18 and 70 years with osteoarthritis of the hip, 75 in the short stem and 75 in the conventional stem group. Mean age: 60 years (SD 7). Interventions: the Collum Femoris Preserving short stem versus the Zweymuller Alloclassic conventional stem. Main outcome measures The Dutch version of the Hip Disability and Osteoarthritis Outcome Score (HOOS). Secondary outcomes measures: Harris Hip Score, the Physical Component Scale of the SF12, the Timed Up and Go test, Pain and the EQ-5D. Feasibility outcomes: continued blinding, protocol adherence and follow-up success rate. Results No significant difference between the two groups. Mean HOOS total score in the short stem group increased 32.7 points from 36.6 (95% CI 32.9 to 40.2) preoperatively to 69.3 (95% CI 66.4 to 72.1) at 3 months follow-up. Mean HOOS total score in the conventional straight stem group increased 36.3 points from 37.1 (95% CI 33.9 to 40.3) preoperatively to 73.4 (95% CI 70.3 to 76.4) at 3 months follow-up. 91.2% of patients remained blinded at 2 years follow-up. Both protocol adherence and follow-up success rate were 98%. Conclusions Functional result at 3 months and 2 years after short stem THA is not superior to conventional cementless THA. There were more perioperative and postoperative complications in the short stem group. Direct comparison of two hip implants in a double-blinded randomised controlled trial is feasible. Trial registration number NTR1560. PMID:29042371

Standardized UXO Technology Demonstration Site, Scoring Record No. 943

DTIC Science & Technology

2014-08-01

COLLERAN ROAD ABERDEEN PROVING GROUND, MARYLAND 21005-5059 Printed on Recycled Paper TEDT-AT-SL-M MEMORANDUM FOR Program Manager – SERDP...equipment. Small munitions grid Contains 300 grid cells . The center of each grid cell contains either munitions, clutter, or nothing with a portion...weather was warm and the field dry throughout the survey period for Battelle. 12 3.3.3 Soil Moisture Three soil probes were placed at various

Using the STROBE statement to assess reporting in blindness prevalence surveys in low and middle income countries.

PubMed

Ramke, Jacqueline; Palagyi, Anna; Jordan, Vanessa; Petkovic, Jennifer; Gilbert, Clare E

2017-01-01

Cross-sectional blindness prevalence surveys are essential to plan and monitor eye care services. Incomplete or inaccurate reporting can prevent effective translation of research findings. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement is a 32 item checklist developed to improve reporting of observational studies. The aim of this study was to assess the completeness of reporting in blindness prevalence surveys in low and middle income countries (LMICs) using STROBE. MEDLINE, EMBASE and Web of Science databases were searched on April 8 2016 to identify cross-sectional blindness prevalence surveys undertaken in LMICs and published after STROBE was published in December 2007. The STROBE tool was applied to all included studies, and each STROBE item was categorized as 'yes' (met criteria), 'no' (did not meet criteria) or 'not applicable'. The 'Completeness of reporting (COR) score' for each manuscript was calculated: COR score = yes / [yes + no]. In journals with included studies the instructions to authors and reviewers were checked for reference to STROBE. The 89 included studies were undertaken in 32 countries and published in 37 journals. The mean COR score was 60.9% (95% confidence interval [CI] 58.1-63.7%; range 30.8-88.9%). The mean COR score did not differ between surveys published in journals with author instructions referring to STROBE (10/37 journals; 61.1%, 95%CI 56.4-65.8%) or in journals where STROBE was not mentioned (60.9%, 95%CI 57.4-64.3%; p = 0.93). While reporting in blindness prevalence surveys is strong in some areas, others need improvement. We recommend that more journals adopt the STROBE checklist and ensure it is used by authors and reviewers.

Effects of kinesiotaping on foot posture in participants with pronated foot: a quasi-randomised, double-blind study.

PubMed

Luque-Suarez, Alejandro; Gijon-Nogueron, Gabriel; Baron-Lopez, Francisco Javier; Labajos-Manzanares, Maria Teresa; Hush, Julia; Hancock, Mark Jonathan

2014-03-01

To investigate whether kinesiotaping improves excessive foot pronation compared with sham kinesiotaping. Quasi-randomised, double-blind study. One primary care centre. One hundred and thirty participants were screened for inclusion. Sixty-eight participants with pronated feet [Foot Posture Index (FPI)≥ 6] were enrolled, and the follow-up rate was 100%. Participants were allocated into one of two groups: an experimental kinesiotaping group (KT1) and a sham taping group (KT2). Measures were collected by a blinded assessor at baseline, and 1 minute, 10 minutes, 60 minutes and 24 hours after taping. The primary outcome was total FPI score, and the secondary outcome was rear-foot FPI score. There were no significant differences in total FPI score between kinesiotaping and sham taping at any time point. Similarly, there were no significant differences in rear-foot FPI score, apart from at 60-minute follow-up when the difference between groups was significant (P=0.04) but the effect size was very small (0.85 points on the rear-foot FPI score between -6 and +6). Kinesiotaping does not correct foot pronation compared with sham kinesiotaping in people with pronated feet. Copyright © 2013 Chartered Society of Physiotherapy. All rights reserved.

Lifestyle in Visually Impaired or Blind Massage Therapists: A Preliminary Study.

PubMed

Hung, Shu-Ling; Chen, Mei-Fang; Lin, Yu-Hua; Kao, Chia-Chan; Chang, Ya-Wen; Chan, Hui-Shan

2017-11-09

Lifestyle is among the most important factors affecting individual health status. Limited access to health information may limit the ability of people with visual impairment or blindness to practice healthy lifestyles. However, no studies have investigated how lifestyle practices affect health specifically in visually impaired and blind populations. The aim of this study was to investigate the lifestyle behaviors of visually impaired and blind massage therapists (VIBMTs) in Taiwan. This exploratory study used a purposive sampling technique to recruit 50 VIBMTs who were employed at massage stations in southern Taiwan. All of the participants completed the Health-Promoting Lifestyle Profile II (HPLP-II) and a survey of demographic characteristics. Descriptive and inferential statistical tests, including the Mann-Whitney U test and the Kruskal-Wallis H test, were used. Statistical significance was defined as p < .05 in two-tailed tests. Fifty participants completed both the HPLP-II and the demographic survey. The mean subscale score for the HPLP-II was 2.52 ± 0.37. The lowest scores were on the physical activity (2.09 ± 0.67) and nutrition (2.35 ± 0.39) subscales, and the highest scores were on the spiritual growth (2.89 ± 0.56) and interpersonal relations (2.79 ± 0.46) subscales. Scores on the stress management and physical activity subscales were significantly higher in men than in women (p < .05). In addition, mean HPLP-II scores were significantly higher in VIBMTs who exercised regularly compared with those who did not (p < .05). Compared with nonsmokers, current smokers had significantly higher scores on the stress management subscale (p < .05). The low physical activity scores in this population may be improved by developing physical activity programs for the home and workplace and by establishing community recreational and exercise facilities for visually impaired populations. The low scores for nutrition may be improved by establishing nutrition education programs that are designed specifically for VIBMTs to increase their consumption of fresh produce and other healthy foods and by requiring food manufacturers to use labels that may be easily read or understood by visually impaired populations.

Tactile drawings, ethics, and a sanctuary: metaphoric devices invented by a blind woman.

PubMed

Kennedy, John M

2013-01-01

Until the last two decades, indications that blind people would understand and create pictures were sparse. EW, a totally blind adult, who began making raised-line drawings in her thirties, created a portfolio of several hundred sketches in nine years. She selects her own topics and invents her treatments of the subjects. What is of special interest here is that two of her drawings, shown in the present paper, depict places but also use devices to indicate one is a sanctuary and the other concerns a tragic era, using metaphor. Lightness of line in a forest drawing indicates it is out of reality, enchanted, and a sanctuary. A tilted grid in a drawing of a Holocaust memorial shows the events at issue were twisted and crooked. The devices are metaphoric and novel. The drawings deal with an ontological category--values--for which metaphorical devices in raised-line depictions have not previously been considered.

Expandable Grids: A User Interface Visualization Technique and a Policy Semantics to Support Fast, Accurate Security and Privacy Policy Authoring

DTIC Science & Technology

2008-07-01

dropout rate amongst Grid participants suggests participants found the Grid more frustrating to use, and subjective satisfaction scores show... learned more than N years of graduate school could ever teach me, and my sister, who was always there for me when my Black Friday letters came. Abstract...greatly affect whether policies match their authors’ intentions ; a bad user interface can lead to policies with many errors, while a good user interface

Oral health status of handicapped primary school pupils in Dar es Salaam, Tanzania.

PubMed

Simon, E N M; Matee, M I; Scheutz, F

2008-03-01

There is hardly any information regarding oral health status of handicapped primary school pupils in Tanzania. Determination of their oral health status could help in planning sustainable intervention programmes for this disadvantaged group. To determine caries and periodontal status and treatment needs of handicapped primary school pupils in Dar es Salaam, Tanzania. A descriptive cross-sectional study. Uhuru Mchanganyiko and Buguruni special schools, Dar es Salaam. The sample consisted of 179 (55.8%) males and 142 (44.2%) females aged between 7 and 22 years. Majority (71%) were deaf followed by blind (17.8%) and mentally retarded (8.7%). Six (1.9%) pupils were both deaf and blind, while one (0.3%) pupil was blind and mentally retarded. Forty one (12.8%) pupils had at least one decayed deciduous tooth, with the mean (dmfs) ranging from 0.25 to 3.24. The deaf had the highest mean decayed surfaces, followed by the mentally retarded and the blind. There was only one (0.3%) pupil who had a filled deciduous tooth. Thirty three (10.3%) pupils had decayed permanent teeth and 31 (9.7%) had missing permanent teeth. None of the decayed permanent teeth were restored. The blind had the lowest mean deciduous surfaces (DS) scores of between 0 and 1.0. In the mentally retarded group the mean DS ranged from 0.25 to 1.75. About 73.5% of the studied group had bleeding of the gums, with the blind having the highest mean bleeding index scores (p < 0.001) and about 82.8% of the pupils had calculus, with highest mean scores mainly among the blind (p = 0.008). The caries prevalence among handicapped primary school pupils was quite low. However, there was relatively high level of gingival bleeding and calculus. Regarding treatment needs, 23% required dental fillings mainly of one and two surface restorations and 82% required scaling and polishing. Despite these treatment needs these pupils had not received any dental attention.

VRT (verbal reasoning test): a new test for assessment of verbal reasoning. Test realization and Italian normative data from a multicentric study.

PubMed

Basagni, Benedetta; Luzzatti, Claudio; Navarrete, Eduardo; Caputo, Marina; Scrocco, Gessica; Damora, Alessio; Giunchi, Laura; Gemignani, Paola; Caiazzo, Annarita; Gambini, Maria Grazia; Avesani, Renato; Mancuso, Mauro; Trojano, Luigi; De Tanti, Antonio

2017-04-01

Verbal reasoning is a complex, multicomponent function, which involves activation of functional processes and neural circuits distributed in both brain hemispheres. Thus, this ability is often impaired after brain injury. The aim of the present study is to describe the construction of a new verbal reasoning test (VRT) for patients with brain injury and to provide normative values in a sample of healthy Italian participants. Three hundred and eighty healthy Italian subjects (193 women and 187 men) of different ages (range 16-75 years) and educational level (primary school to postgraduate degree) underwent the VRT. VRT is composed of seven subtests, investigating seven different domains. Multiple linear regression analysis revealed a significant effect of age and education on the participants' performance in terms of both VRT total score and all seven subtest scores. No gender effect was found. A correction grid for raw scores was built from the linear equation derived from the scores. Inferential cut-off scores were estimated using a non-parametric technique, and equivalent scores were computed. We also provided a grid for the correction of results by z scores.

Rapid Design of Knowledge-Based Scoring Potentials for Enrichment of Near-Native Geometries in Protein-Protein Docking.

PubMed

Sasse, Alexander; de Vries, Sjoerd J; Schindler, Christina E M; de Beauchêne, Isaure Chauvot; Zacharias, Martin

2017-01-01

Protein-protein docking protocols aim to predict the structures of protein-protein complexes based on the structure of individual partners. Docking protocols usually include several steps of sampling, clustering, refinement and re-scoring. The scoring step is one of the bottlenecks in the performance of many state-of-the-art protocols. The performance of scoring functions depends on the quality of the generated structures and its coupling to the sampling algorithm. A tool kit, GRADSCOPT (GRid Accelerated Directly SCoring OPTimizing), was designed to allow rapid development and optimization of different knowledge-based scoring potentials for specific objectives in protein-protein docking. Different atomistic and coarse-grained potentials can be created by a grid-accelerated directly scoring dependent Monte-Carlo annealing or by a linear regression optimization. We demonstrate that the scoring functions generated by our approach are similar to or even outperform state-of-the-art scoring functions for predicting near-native solutions. Of additional importance, we find that potentials specifically trained to identify the native bound complex perform rather poorly on identifying acceptable or medium quality (near-native) solutions. In contrast, atomistic long-range contact potentials can increase the average fraction of near-native poses by up to a factor 2.5 in the best scored 1% decoys (compared to existing scoring), emphasizing the need of specific docking potentials for different steps in the docking protocol.

An Exploration into Self Concept: A Comparative Analysis between the Adolescents Who Are Sighted and Blind in India

ERIC Educational Resources Information Center

Halder, Santoshi; Datta, Poulomee

2012-01-01

The purpose of this study was to explore the self concept of adolescents who are sighted and blind with respect to gender in India. The sample was made up of 160 participants aged 15 to 18 years: of whom 100 were sighted and 60 were blind. The results of the t-tests illustrated that sighted male adolescents scored higher in the overall…

Enhanced perception of pitch changes in speech and music in early blind adults.

PubMed

Arnaud, Laureline; Gracco, Vincent; Ménard, Lucie

2018-06-12

It is well known that congenitally blind adults have enhanced auditory processing for some tasks. For instance, they show supra-normal capacity to perceive accelerated speech. However, only a few studies have investigated basic auditory processing in this population. In this study, we investigated if pitch processing enhancement in the blind is a domain-general or domain-specific phenomenon, and if pitch processing shares the same properties as in the sighted regarding how scores from different domains are associated. Fifteen congenitally blind adults and fifteen sighted adults participated in the study. We first created a set of personalized native and non-native vowel stimuli using an identification and rating task. Then, an adaptive discrimination paradigm was used to determine the frequency difference limen for pitch direction identification of speech (native and non-native vowels) and non-speech stimuli (musical instruments and pure tones). The results show that the blind participants had better discrimination thresholds than controls for native vowels, music stimuli, and pure tones. Whereas within the blind group, the discrimination thresholds were smaller for musical stimuli than speech stimuli, replicating previous findings in sighted participants, we did not find this effect in the current control group. Further analyses indicate that older sighted participants show higher thresholds for instrument sounds compared to speech sounds. This effect of age was not found in the blind group. Moreover, the scores across domains were not associated to the same extent in the blind as they were in the sighted. In conclusion, in addition to providing further evidence of compensatory auditory mechanisms in early blind individuals, our results point to differences in how auditory processing is modulated in this population. Copyright © 2018 Elsevier Ltd. All rights reserved.

Color-Blind Racial Beliefs Among Dental Students and Faculty.

PubMed

Su, Yu; Behar-Horenstein, Linda S

2017-09-01

Providing culturally competent patient care requires an awareness of racial and cultural norms as well as a recognition of racism. Yet, there is a paucity of research devoted to this problem. In dental education, increased attention has focused on eliminating oral health care disparities due to ethnicity and race. Further investigation to determine the relationship between color-blind attitudes (failing to recognize the impact of race and racism on social justice) and dental educators' cultural competence is needed. The aim of this study was to determine dental faculty and student baseline color-blind racial attitudes scale scores, using the color-blind racial attitudes scale (CoBRAS). This 20-item instrument that measures three subscales of color-blind racial attitudes (Unawareness of Racial Privilege, Institutional Discrimination, and Blatant Racial Issues) was administered to student and faculty groups at one U.S. dental school. Out of a total 245 students in three class years, 235 responded to all items, for a response rate of 96%; out of a total 77 faculty members invited to participate, 71 responded to all items, for a response rate of 92%. Underrepresented minority (URM) faculty scored significantly higher on the Institutional Discrimination subscale and lower on Unawareness of Racial Privilege compared to non-URM students. Males scored significantly higher on Institutional Discrimination and Blatant Racial Issues compared to females. Compared to white students, URM students scored lower on all three subscales. The findings were consistent with previous studies indicating that female and URM students were more sensitive to racism compared to male and majority students. The findings that white faculty had higher awareness of racial privilege than white students and that URM faculty were less aware of institutional discrimination than URM students provided new information. These findings suggest that dental faculty members need professional development opportunities that promote becoming color-conscious and understanding privilege and biases, that model instruction on discussing race and racism, and that extend beyond a brief workshop.

Designing for Wide-Area Situation Awareness in Future Power Grid Operations

NASA Astrophysics Data System (ADS)

Tran, Fiona F.

Power grid operation uncertainty and complexity continue to increase with the rise of electricity market deregulation, renewable generation, and interconnectedness between multiple jurisdictions. Human operators need appropriate wide-area visualizations to help them monitor system status to ensure reliable operation of the interconnected power grid. We observed transmission operations at a control centre, conducted critical incident interviews, and led focus group sessions with operators. The results informed a Work Domain Analysis of power grid operations, which in turn informed an Ecological Interface Design concept for wide-area monitoring. I validated design concepts through tabletop discussions and a usability evaluation with operators, earning a mean System Usability Scale score of 77 out of 90. The design concepts aim to support an operator's complete and accurate understanding of the power grid state, which operators increasingly require due to the critical nature of power grid infrastructure and growing sources of system uncertainty.

Visual function and quality of life among visually impaired and cataract operated adults. The Pakistan National Blindness and Visual Impairment Survey.

PubMed

Taylor, Amy E; Shah, Shaheen P; Gilbert, Clare E; Jadoon, Mohammad Z; Bourne, Rupert R A; Dineen, Brendan; Johnson, Gordon J; Khan, Mohammad D

2008-01-01

To assess visual functioning and quality of life in a representative sample of normally sighted, visually impaired and cataract operated individuals aged >or= 30 years in Pakistan. As part of the Pakistan National Blindness and Visual Impairment Survey, visual functioning (VF) and quality of life (QOL) questionnaires were administered to participants with presenting visual acuity less than 6/60 in either eye, aphakes/pseudophakes and a phakic sample with normal acuity (>or= 6/12 both eyes). Of 16,507 adults included in the survey, 2329 questionnaires were administered. There were strong correlations between visual acuity and VF/QOL. Mean VF and median QOL scores in normally sighted phakic individuals were 81.1 and 88.9, respectively, but were only 34.8 and 64.9 in blind unoperated individuals. In the cataract operated population overall mean VF and median QOL scores were 49.3 and 75.0. Both VF and QOL scores were lower in operated individuals than unoperated individuals (p < 0.001). Among operated individuals, rural dwelling and illiteracy were associated with lower VF and QOL scores (p all < 0.02). Although in multivariable analysis bilateral pseudophakes had similar VF scores to bilateral aphakes they had significantly better QOL scores (p = 0.001). Cataract surgery in Pakistan has not led to VF and QOL scores equivalent to those in unoperated individuals with the same levels of visual acuity. The higher proportion of intraocular lens surgery in recent years is likely to improve QOL following cataract surgery. Further focus is needed on rural and illiterate populations, to ensure that they achieve comparable VF/QOL outcomes following surgery.

Dextrose prolotherapy for knee osteoarthritis: a randomized controlled trial.

PubMed

Rabago, David; Patterson, Jeffrey J; Mundt, Marlon; Kijowski, Richard; Grettie, Jessica; Segal, Neil A; Zgierska, Aleksandra

2013-01-01

Knee osteoarthritis is a common, debilitating chronic disease. Prolotherapy is an injection therapy for chronic musculoskeletal pain. We conducted a 3-arm, blinded (injector, assessor, injection group participants), randomized controlled trial to assess the efficacy of prolotherapy for knee osteoarthritis. Ninety adults with at least 3 months of painful knee osteoarthritis were randomized to blinded injection (dextrose prolotherapy or saline) or at-home exercise. Extra- and intra-articular injections were done at 1, 5, and 9 weeks with as-needed additional treatments at weeks 13 and 17. Exercise participants received an exercise manual and in-person instruction. Outcome measures included a composite score on the Western Ontario McMaster University Osteoarthritis Index (WOMAC; 100 points); knee pain scale (KPS; individual knee), post-procedure opioid medication use, and participant satisfaction. Intention-to-treat analysis using analysis of variance was used. No baseline differences existed between groups. All groups reported improved composite WOMAC scores compared with baseline status (P <.01) at 52 weeks. Adjusted for sex, age, and body mass index, WOMAC scores for patients receiving dextrose prolotherapy improved more (P <.05) at 52 weeks than did scores for patients receiving saline and exercise (score change: 15.3 ± 3.5 vs 7.6 ± 3.4, and 8.2 ± 3.3 points, respectively) and exceeded the WOMAC-based minimal clinically important difference. Individual knee pain scores also improved more in the prolotherapy group (P = .05). Use of prescribed postprocedure opioid medication resulted in rapid diminution of injection-related pain. Satisfaction with prolotherapy was high. There were no adverse events. Prolotherapy resulted in clinically meaningful sustained improvement of pain, function, and stiffness scores for knee osteoarthritis compared with blinded saline injections and at-home exercises.

Obsessive-compulsive symptoms in a randomized, double-blind study with olanzapine or risperidone in young patients with early psychosis.

PubMed

van Nimwegen, Lonneke; de Haan, Lieuwe; van Beveren, Nico; Laan, Winfried; van den Brink, Wim; Linszen, Don

2008-04-01

The prevalence of obsessive-compulsive symptoms (OCS) in patients with schizophrenia is relatively high. Antipsychotics have been found to influence OCS. To determine whether induction or severity of OCS differs during treatment with olanzapine or risperidone in young patients with early psychosis. One hundred twenty-two patients with a Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder were randomized in a double-blind design to groups of 6 weeks' treatment with olanzapine (n = 59) or risperidone (n = 63), with a mean dose of 11.3 mg olanzapine and 3.0 mg risperidone at 6 weeks. Primary outcome measures were the mean baseline-to-endpoint change in total score on the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). Treatment with olanzapine was associated with greater decreases in Y-BOCS total score than treatment with risperidone in total group (N = 122: -2.2 vs -0.3, z = -2.651, P < 0.01), in patients with baseline Y-BOCS total score greater than 0 (n = 58: -5.1 vs -0.4, z = -2.717, P < 0.01), and in patients with baseline Y-BOCS total score greater than 10 (n = 29: -7.1 vs -0.6, z = -2.138, P = 0.032). In this randomized, 6-week, double-blind trial, we found a significant and clinically relevant difference in decrease in Y-BOCS scores favoring olanzapine compared with risperidone.

Prospective, multicentre, randomized, double-blind study of the efficacy of escitalopram versus citalopram in outpatient treatment of major depressive disorder.

PubMed

Moore, Nicholas; Verdoux, Hélène; Fantino, Bruno

2005-05-01

Pre-clinical studies, active-control clinical trials and meta-analyses indicate that escitalopram (S-citalopram) might be more effective than citalopram, the racemic mixture of S- and R-citalopram. The present study aimed to confirm the superior efficacy of escitalopram over citalopram. A double-blind, randomized clinical trial was performed in which general practitioners and psychiatrists compared fixed doses of escitalopram (20 mg/day) with citalopram (40 mg/day) over 8 weeks in outpatients with major depressive disorder (MDD) [baseline Montgomery-Asberg Depression Rating Scale (MADRS) score > or =30]. Primary efficacy parameter was change from baseline to last assessment in the MADRS total score. Out of 138 (aged 44.1+/-10.9 years; initial MADRS score 36.3+/-4.8) and 142 (aged 46.2+/-11.1 years; initial MADRS score 35.7+/-4.4) evaluable patients who were randomized to escitalopram and citalopram, respectively, six and 15 withdrew prematurely (P=0.05). The MADRS score decreased more in the escitalopram than in the citalopram arm (-22.4+/-12.9 versus -20.3+/-12.7; P<0.05). There were more treatment responders with escitalopram (76.1%) than with citalopram (61.3%, P<0.01). Adjusted remitter rates were 56.1% and 43.6%, respectively (P<0.05). Tolerability was similar in both groups. This randomized double-blind trial confirms that escitalopram has a superior effect to citalopram in MDD.

Comparison of NTF Experimental Data with CFD Predictions from the Third AIAA CFD Drag Prediction Workshop

NASA Technical Reports Server (NTRS)

Vassberg, John C.; Tinoco, Edward N.; Mani, Mori; Levy, David; Zickuhr, Tom; Mavriplis, Dimitri J.; Wahls, Richard A.; Morrison, Joseph H.; Brodersen, Olaf P.; Eisfeld, Bernhard;

Efficacy and Safety of Paliperidone Palmitate 3-Month Formulation for Patients with Schizophrenia: A Randomized, Multicenter, Double-Blind, Noninferiority Study

PubMed Central

Xu, Haiyan; Gopal, Srihari; Nuamah, Isaac; Ravenstijn, Paulien; Janik, Adam; Schotte, Alain; Hough, David; Fleischhacker, Wolfgang W.

2016-01-01

Background: This double-blind, parallel-group, multicenter, phase-3 study was designed to test the noninferiority of paliperidone palmitate 3-month formulation (PP3M) to the currently marketed 1-month formulation (PP1M) in patients (age 18–70 years) with schizophrenia, previously stabilized on PP1M. Methods: After screening (≤3 weeks) and a 17-week, flexible-dosed, open-label phase (PP1M: day 1 [150mg eq. deltoid], day 8 [100mg eq. deltoid.], weeks 5, 9, and 13 [50, 75, 100, or 150mg eq., deltoid/gluteal]), clinically stable patients were randomized (1:1) to PP3M (fixed-dose, 175, 263, 350, or 525mg eq. deltoid/gluteal) or PP1M (fixed-dose, 50, 75, 100, or 150mg eq. deltoid/gluteal) for a 48-week double-blind phase. Results: Overall, 1016/1429 open-label patients entered the double-blind phase (PP3M: n=504; PP1M: n=512) and 842 completed it (including patients with relapse). PP3M was noninferior to PP1M: relapse rates were similar in both groups (PP3M: n=37, 8%; PP1M: n=45, 9%; difference in relapse-free rate: 1.2% [95% CI:-2.7%; 5.1%]) based on Kaplan-Meier estimates (primary efficacy). Secondary endpoint results (changes from double-blind baseline in positive and negative symptom score total and subscale scores, Clinical Global Impression-Severity, and Personal and Social Performance scores) were consistent with primary endpoint results. No clinically relevant differences were observed in pharmacokinetic exposures between PP3M and PP1M. Both groups had similar tolerability profiles; increased weight was the most common treatment-emergent adverse event (double-blind phase; 21% each). No new safety signals were detected. Conclusion: Taken together, PP3M with its 3-month dosing interval is a unique option for relapse prevention in schizophrenia. PMID:26902950

Dental health status among sensory impaired and blind institutionalized children aged 6 to 20 years.

PubMed

Sanjay, Venkataraam; Shetty, Sumanth M; Shetty, Rashmi G; Managoli, Noopur A; Gugawad, Sachin C; Hitesh, D

2014-02-01

This study was planned to assess the dental caries status among disabled children as dental health is an integral part of general body health and this group is deprived of health care needs. A sample of 310 disabled children was gathered including 195- Hearing impaired, 115 - blind. Of which 226 were males and 84 were females. A study questionnaire was prepared to include demographic information and WHO oral health assessment form (1997) to record dental caries status.Data was analysed using student's test and ANOVA test was used at p≤0.05. The overall mean for DMFT scores for males and females was 2.11 (1.753) and 1.75 (1.275) respectively. Similarly overall mean for dft was 0.31 (0.254) for males and 0.27 (0.143) for females. Mean DMFT of blind students was more as compared to hearing impaired ones as 2.16 (2.005) and 1.80 (1.264) respectively. Age factor showed a significant increase in the mean DMFT scores with advancing age at p ≤ 0.001. Overall mean scores of caries was very high and it increased with increasing age. Blind children experienced more caries then hearing impaired children in permanent, whereas it was opposite in primary dentition. So there is urgent need of both comprehensive and incremental dental care for this subgroup of population. How to cite the article: Sanjay V, Shetty SM, Shetty RG, Managoli NA, Gugawad SC, Hitesh D. Dental health status among sensory impaired and blind institutionalized children aged 6 to 20 years. J Int Oral Health 2014;6(1):55-8.

Dental health status among sensory impaired and blind institutionalized children aged 6 to 20 years

PubMed Central

Sanjay, Venkataraam; Shetty, Sumanth M; Shetty, Rashmi G; Managoli, Noopur A; Gugawad, Sachin C; Hitesh, D

2014-01-01

Background: This study was planned to assess the dental caries status among disabled children as dental health is an integral part of general body health and this group is deprived of health care needs. Materials & Methods: A sample of 310 disabled children was gathered including 195- Hearing impaired, 115 – blind. Of which 226 were males and 84 were females. A study questionnaire was prepared to include demographic information and WHO oral health assessment form (1997) to record dental caries status.Data was analysed using student’s test and ANOVA test was used at p≤0.05. Results: The overall mean for DMFT scores for males and females was 2.11 (1.753) and 1.75 (1.275) respectively. Similarly overall mean for dft was 0.31 (0.254) for males and 0.27 (0.143) for females. Mean DMFT of blind students was more as compared to hearing impaired ones as 2.16 (2.005) and 1.80 (1.264) respectively. Age factor showed a significant increase in the mean DMFT scores with advancing age at p ≤ 0.001. Conclusion: Overall mean scores of caries was very high and it increased with increasing age. Blind children experienced more caries then hearing impaired children in permanent, whereas it was opposite in primary dentition. So there is urgent need of both comprehensive and incremental dental care for this subgroup of population. How to cite the article: Sanjay V, Shetty SM, Shetty RG, Managoli NA, Gugawad SC, Hitesh D. Dental health status among sensory impaired and blind institutionalized children aged 6 to 20 years. J Int Oral Health 2014;6(1):55-8. PMID:24653604

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF ORAL MATRICARIA RECUTITA (CHAMOMILE) EXTRACT THERAPY OF GENERALIZED ANXIETY DISORDER

PubMed Central

Amsterdam, Jay D.; Li, Yimei; Soeller, Irene; Rockwell, Kenneth; Mao, Jun James; Shults, Justine

2013-01-01

Objective We conducted a randomized, double-blind, placebo-controlled efficacy and tolerability trial of Matricaria recutita (chamomile) extract therapy in patients with mild to moderate Generalized Anxiety Disorder (GAD). We hypothesized that chamomile would be superior to placebo in reducing GAD symptoms with a comparable tolerability profile. Materials & Methods 61 outpatients with mild to moderate GAD were enrolled and 57 were randomized to either double blind chamomile extract (n=28) or placebo (n=29) therapy for 8 weeks. The study was powered to detect a statistically significant and clinically meaningful group difference in change over time in total Hamilton Anxiety Rating (HAM-A) scores. Secondary outcomes included change in the Beck Anxiety Inventory score, Psychological Well Being score, Clinical Global Impression Severity score, and the proportion of patients with ≥50% reduction in baseline HAM-A score. Results We observed a significantly greater reduction in mean total HAM-A score during chamomile versus placebo therapy (p=0.047). Although the study was not powered to identify small to moderate differences in secondary outcomes, we observed a positive change in all secondary outcomes in the same direction as the primary outcome measure. One patient in each treatment group discontinued therapy for adverse events. The proportion of patients experiencing 0, 1, 2, or ≥3 adverse events was not significantly different between groups (p=0.417). Conclusion This is the first, controlled clinical trial of chamomile extract for GAD. The results suggest that chamomile may have modest anxiolytic activity in patients with mild to moderate GAD. Future studies are needed to replicate these observations. PMID:19593179

What's Race Got to Do with It? Preservice Teachers and White Racial Identity

ERIC Educational Resources Information Center

Peters, Terri; Margolin, Marcia; Fragnoli, Kristi; Bloom, Diane

2016-01-01

This study examined changes in student teachers' White racial identity and color-blindness (using scores on the WRCDS-R and CoBRAS), as well as their perceptions of working with students of color, following a semester of student teaching in diverse classrooms. Paired samples t-tests demonstrated student teachers were more color-blind about…

Music for Blind and Physically Handicapped Individuals. Fact Sheet.

ERIC Educational Resources Information Center

Library of Congress, Washington, DC. National Library Service for the Blind and Physically Handicapped.

With the cooperation of composers and publishers who grant permission to use copyrighted works, the National Library Service for the Blind and Physically Handicapped (NLS) of the Library of Congress selects and produces music scores in braille and large-print formats, and music magazines and books about music and musicians in large-print, braille,…

Adaptation of Psychological Assessment Tools for Administration by Blind and Visually Impaired Psychologists and Trainees.

ERIC Educational Resources Information Center

Keller, Richard M.

This paper focuses on challenges to psychologists and psychology graduate students who are blind or visually impaired in the administration and scoring of various psychological tests. Organized by specific tests, the paper highlights those aspects of testing which pose particular difficulty to testers with visual impairments and also describes…

Examining the Influence of Campus Diversity Experiences and Color-Blind Racial Ideology on Students' Social Justice Attitudes

ERIC Educational Resources Information Center

Lewis, Jioni A.; Neville, Helen A.; Spanierman, Lisa B.

2012-01-01

This study examined the relationships between color-blind racial ideology (CBRI) and social justice attitudes among a racially diverse sample of first-year college students (N = 431). Results indicated that CBRI scores partially mediated the relation between participation in campus diversity experiences and social justice attitudes for Black,…

The association between social deprivation and the prevalence and severity of dental caries and fluorosis in populations with and without water fluoridation.

PubMed

McGrady, Michael G; Ellwood, Roger P; Maguire, Anne; Goodwin, Michaela; Boothman, Nicola; Pretty, Iain A

2012-12-28

To determine the association between social deprivation and the prevalence of caries (including caries lesions restricted to enamel) and enamel fluorosis in areas that are served by either fluoridated or non-fluoridated drinking water using clinical scoring, remote blinded, photographic scoring for caries and fluorosis. The study also aimed to explore the use of remote, blinded methodologies to minimize the effect of examiner bias. Subjects were male and female lifetime residents aged 11-13 years. Clinical assessments of caries and fluorosis were performed on permanent teeth using ICDAS and blind scoring of standardized photographs of maxillary central incisors using TF Index (with cases for fluorosis defined as TF > 0). Data from 1783 subjects were available (910 Newcastle, 873 Manchester). Levels of material deprivation (Index of Multiple Deprivation) were comparable for both populations (Newcastle mean 35.22, range 2.77-78.85; Manchester mean 37.04, range 1.84-84.02). Subjects in the fluoridated population had significantly less caries experience than the non-fluoridated population when assessed by clinical scores or photographic scores across all quintiles of deprivation for white spot lesions: Newcastle mean DMFT 2.94 (clinical); 2.51 (photo), Manchester mean DMFT 4.48 (clinical); 3.44 (photo) and caries into dentine (Newcastle Mean DMFT 0.65 (clinical); 0.58 (photo), Manchester mean DMFT 1.07 (clinical); 0.98 (photo). The only exception being for the least deprived quintile for caries into dentine where there were no significant differences between the cities: Newcastle mean DMFT 0.38 (clinical); 0.36 (photo), Manchester mean DMFT 0.45 (clinical); 0.39 (photo). The odds ratio for white spot caries experience (or worse) in Manchester was 1.9 relative to Newcastle. The odds ratio for caries into dentine in Manchester was 1.8 relative to Newcastle. The odds ratio for developing fluorosis in Newcastle was 3.3 relative to Manchester. Water fluoridation appears to reduce the social class gradient between deprivation and caries experience when considering caries into dentine. However, this was associated with an increased risk of developing mild fluorosis. The use of intra-oral cameras and remote scoring of photographs for caries demonstrated good potential for blinded scoring.

The association between social deprivation and the prevalence and severity of dental caries and fluorosis in populations with and without water fluoridation

PubMed Central

2012-01-01

Background To determine the association between social deprivation and the prevalence of caries (including caries lesions restricted to enamel) and enamel fluorosis in areas that are served by either fluoridated or non-fluoridated drinking water using clinical scoring, remote blinded, photographic scoring for caries and fluorosis. The study also aimed to explore the use of remote, blinded methodologies to minimize the effect of examiner bias. Methods Subjects were male and female lifetime residents aged 11–13 years. Clinical assessments of caries and fluorosis were performed on permanent teeth using ICDAS and blind scoring of standardized photographs of maxillary central incisors using TF Index (with cases for fluorosis defined as TF > 0). Results Data from 1783 subjects were available (910 Newcastle, 873 Manchester). Levels of material deprivation (Index of Multiple Deprivation) were comparable for both populations (Newcastle mean 35.22, range 2.77-78.85; Manchester mean 37.04, range 1.84-84.02). Subjects in the fluoridated population had significantly less caries experience than the non-fluoridated population when assessed by clinical scores or photographic scores across all quintiles of deprivation for white spot lesions: Newcastle mean DMFT 2.94 (clinical); 2.51 (photo), Manchester mean DMFT 4.48 (clinical); 3.44 (photo) and caries into dentine (Newcastle Mean DMFT 0.65 (clinical); 0.58 (photo), Manchester mean DMFT 1.07 (clinical); 0.98 (photo). The only exception being for the least deprived quintile for caries into dentine where there were no significant differences between the cities: Newcastle mean DMFT 0.38 (clinical); 0.36 (photo), Manchester mean DMFT 0.45 (clinical); 0.39 (photo). The odds ratio for white spot caries experience (or worse) in Manchester was 1.9 relative to Newcastle. The odds ratio for caries into dentine in Manchester was 1.8 relative to Newcastle. The odds ratio for developing fluorosis in Newcastle was 3.3 relative to Manchester. Conclusions Water fluoridation appears to reduce the social class gradient between deprivation and caries experience when considering caries into dentine. However, this was associated with an increased risk of developing mild fluorosis. The use of intra-oral cameras and remote scoring of photographs for caries demonstrated good potential for blinded scoring. PMID:23272895

Validation of a new ENT emergencies course for first-on-call doctors.

PubMed

Swords, C; Smith, M E; Wasson, J D; Qayyum, A; Tysome, J R

2017-02-01

First-on-call ENT cover is often provided by junior doctors with limited ENT experience; yet, they may have to manage life-threatening emergencies. An intensive 1-day simulation course was developed to teach required skills to junior doctors. A prospective, single-blinded design was used. Thirty-seven participants rated their confidence before the course, immediately following the course and after a two-month interval. Blinded assessors scored participant performance in two video-recorded simulated scenarios before and after the course. Participant self-rated confidence was increased in the end-of-course survey (score of 27.5 vs 53.0; p < 0.0001), and this was maintained two to four months after the course (score of 50.5; p < 0.0001). Patient assessment and management in video-recorded emergency scenarios was significantly improved following course completion (score of 9.75 vs 18.75; p = 0.0093). This course represents an effective method of teaching ENT emergency management to junior doctors. ENT induction programmes benefit from the incorporation of a simulation component.

Repetition blindness and homophone blindness in young and older adults.

PubMed

Tyrrell, Caitlin J; James, Lori E; Noble, Paula M

2016-11-01

We tested age effects on repetition blindness (RB), defined as the reduced probability of reporting a target word following presentation of the same word in a rapidly presented list. We also tested age effects on homophone blindness (HB), in which the first word is a homophone of the target word rather than a repeated word. Thirty young and 28 older adults viewed rapidly presented lists of words containing repeated, homophone, or unrepeated word pairs and reported all of the words immediately after each list. Older adults exhibited a greater degree of RB and HB than young adults using a conditional scoring method that provides certainty that blindness has occurred. The existence of RB and HB for both age groups, and increased blindness for older compared to young adults, supports predictions of a binding theory that has successfully accounted for a wide range of phenomena in cognitive aging.

Validity of EuroQOL-5D, time trade-off, and standard gamble for age-related macular degeneration in the Singapore population

PubMed Central

Au Eong, K G; Chan, E W; Luo, N; Wong, S H; Tan, N W H; Lim, T H; Wagle, A M

2012-01-01

Background/aims Utility values of age-related macular degeneration (AMD) in Asian patients are unknown. This study aims to assess utility values and construct validity of the EuroQOL-5D (EQ-5D), time trade-off (TTO), and standard gamble (SG) instruments in the Singapore multi-ethnic AMD population. Methods Cross-sectional, two-centre, institution-based study. Visual acuity (VA), clinical AMD severity, and utility scores on the EQ-5D, TTO, and SG were obtained from 338 AMD patients. VA was analysed in terms of the better-seeing eye (BEVA), worse-seeing eye (WEVA), and weighted average of both eyes (WVA). We evaluated SG on the perfect health-death (SG(death)) and binocular perfect vision-binocular blindness (SG(blindness)) scales. Construct validity was determined by testing a priorihypotheses relating the EQ-5D, TTO, and SG utility scores to VA and clinical AMD severity. Results The mean utilities on the EQ-5D, TTO, SG(death), and SG(blindness) were 0.89, 0.81, 0.86, and 0.90, respectively. EQ-5D scores correlated weakly with BEVA, WEVA, and WVA (Pearson's correlation coefficients −0.291, −0.247, and −0.305 respectively, P<0.001 for all). SG(death) and SG(blindness) demonstrated no correlation with BEVA, WEVA, or WVA (Pearson's correlation coefficients, range −0.06 to −0.125). TTO showed weak association only with WEVA and WVA (correlation coefficients −0.237, −0.228, P<0.0001), but not with BEVA (correlation coefficient −0.161). Clinical AMD severity correlated with EQ-5D and SG(death), but not with TTO and SG(blindness) (P=0.004, 0.002, 0.235, and 0.069, respectively). Conclusions AMD has a negative impact on utilities, although utility scores were high compared with Western cohorts. EQ-5D, TTO, and SG showed suboptimal construct validity, suggesting that health status utilities may not be sufficiently robust for cost-utility analyses in this population. PMID:22222257

Supporting shared decision making using an Option Grid for osteoarthritis of the knee in an interface musculoskeletal clinic: A stepped wedge trial.

PubMed

Elwyn, Glyn; Pickles, Tim; Edwards, Adrian; Kinsey, Katharine; Brain, Kate; Newcombe, Robert G; Firth, Jill; Marrin, Katy; Nye, Alan; Wood, Fiona

2016-04-01

To evaluate whether introducing tools, specifically designed for use in clinical encounters, namely Option Grids, into a clinical practice setting leads to higher levels of shared decision making. A stepped wedge trial design where 6 physiotherapists at an interface clinic in Oldham, UK, were sequentially instructed in how to use an Option Grid for osteoarthritis of the knee. Patients with suspected or confirmed osteoarthritis of the knee were recruited, six per clinician prior to instruction, and six per clinician afterwards. We measured shared decision making, patient knowledge, and readiness to decide. A total of 72 patients were recruited; 36 were allocated to the intervention group. There was an 8.4 point (95% CI 4.4 to 12.2) increase in the Observer OPTION score (range 0-100) in the intervention group. The mean gain in knowledge was 0.9 points (score range 0-5, 95% CI, 0.3 to 1.5). There was no increase in encounter duration. Shared decision making increased when clinicians used the knee osteoarthritis Option Grid. Tools designed to support collaboration and deliberation about treatment options lead to increased levels of shared decision making. Copyright © 2015 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Chromosomal aberrations in Sigmodon hispidus from a Superfund site

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

Bowers, B.; McBee, K.; Lochmiller, R.

1995-12-31

Cotton rats (Sigmodon hispidus) were collected from an EPA Superfund site located on an abandoned oil refinery. Three trapping grids were located on the refinery and three similar grids were located at uncontaminated localities which served as reference sites. Bone marrow metaphase chromosome preparations were examined for chromosomal damage. For each individual, 50 cells were scored for six classes of chromosomal lesions. For the fall 1991 trapping period, mean number of aberrant cells per individual was 2.33, 0.85, and 1.50 for the three Superfund grids., Mean number of aberrant cells per individual was 2.55, 2.55, and 2.12 from the referencemore » grids. Mean number of lesions per cell was 2.77, 0.86, and 1.9 from the Superfund grids, and 3.55, 2.77, and 2.50 from the reference grids. For the spring 1992 trapping period, more damage was observed in animals from both Superfund and reference sites; however, animals from Superfund grids had more damage than animals from reference grids. Mean number of aberrant cells per individual was 3.50, 3.25, and 3.70 from the Superfund grids, and 2.40, 2.11, and 1.40 from the reference grids. Mean number of lesions per cell was 4.80, 4.25, and 5.50 from the Superfund grids, and 2.60, 2.33, and 1.50 from the reference grids. These data suggest animals may be more susceptible to chromosomal damage during winter months, and animals from the Superfund grids appear to be more severely affected than animals from reference grids.« less

Differences between early-blind, late-blind, and blindfolded-sighted people in haptic spatial-configuration learning and resulting memory traces.

PubMed

Postma, Albert; Zuidhoek, Sander; Noordzij, Matthijs L; Kappers, Astrid M L

2007-01-01

The roles of visual and haptic experience in different aspects of haptic processing of objects in peripersonal space are examined. In three trials, early-blind, late-blind, and blindfolded-sighted individuals had to match ten shapes haptically to the cut-outs in a board as fast as possible. Both blind groups were much faster than the sighted in all three trials. All three groups improved considerably from trial to trial. In particular, the sighted group showed a strong improvement from the first to the second trial. While superiority of the blind remained for speeded matching after rotation of the stimulus frame, coordinate positional-memory scores in a non-speeded free-recall trial showed no significant differences between the groups. Moreover, when assessed with a verbal response, categorical spatial-memory appeared strongest in the late-blind group. The role of haptic and visual experience thus appears to depend on the task aspect tested.

Topology and weights in a protein domain interaction network--a novel way to predict protein interactions.

PubMed

Wuchty, Stefan

2006-05-23

While the analysis of unweighted biological webs as diverse as genetic, protein and metabolic networks allowed spectacular insights in the inner workings of a cell, biological networks are not only determined by their static grid of links. In fact, we expect that the heterogeneity in the utilization of connections has a major impact on the organization of cellular activities as well. We consider a web of interactions between protein domains of the Protein Family database (PFAM), which are weighted by a probability score. We apply metrics that combine the static layout and the weights of the underlying interactions. We observe that unweighted measures as well as their weighted counterparts largely share the same trends in the underlying domain interaction network. However, we only find weak signals that weights and the static grid of interactions are connected entities. Therefore assuming that a protein interaction is governed by a single domain interaction, we observe strong and significant correlations of the highest scoring domain interaction and the confidence of protein interactions in the underlying interactions of yeast and fly. Modeling an interaction between proteins if we find a high scoring protein domain interaction we obtain 1, 428 protein interactions among 361 proteins in the human malaria parasite Plasmodium falciparum. Assessing their quality by a logistic regression method we observe that increasing confidence of predicted interactions is accompanied by high scoring domain interactions and elevated levels of functional similarity and evolutionary conservation. Our results indicate that probability scores are randomly distributed, allowing to treat static grid and weights of domain interactions as separate entities. In particular, these finding confirms earlier observations that a protein interaction is a matter of a single interaction event on domain level. As an immediate application, we show a simple way to predict potential protein interactions by utilizing expectation scores of single domain interactions.

ESTCP UXO Discrimination Study. MTADS Demonstration at Camp Sibert Magnetometer / EM61 MkII / GEM-3 Arrays, Gadsden, AL, April 2007

DTIC Science & Technology

2008-08-21

Yuma Proving Ground Open Field ............................................................................... 76 B.3.1 Response Stage... Yuma Proving Ground ZIP (250) Iomega ZIP disk (250 MB version) xv ACKNOWLEDGEMENTS Glenn Harbaugh and Daniel Steinhurst (P.I.) of Nova Research...sites at Aberdeen Proving Ground and Yuma Proving Ground in 2003 and 2004 [6]. At each of the sites, the Calibration Lanes, the Blind Test Grid

Skin texture parameters of the dorsal hand in evaluating skin aging in China.

PubMed

Gao, Qian; Hu, Li-Wen; Wang, Yang; Xu, Wen-Ying; Ouyang, Nan-Ning; Dong, Guo-Qing; Shi, Song-Tian; Liu, Yang

2011-11-01

There are various non-invasive methods in skin morphology for assessing skin aging. The use of digital photography will make it easier and more convenient. In this study, we explored some skin texture parameters for evaluating skin aging using digital image processing. Two hundred and twenty-eight subjects who lived in Sanya, China, were involved. Individual sun exposure history and other factors influencing skin aging were collected by a questionnaire. Meanwhile, we took photos of their dorsal hands. Skin images were graded according to the Beagley-Gibson system. These skin images were also processed using image analysis software. Five skin texture parameters, Angle Num., Angle Max., Angle Diff., Distance and Grids, were produced in reference to the Beagley-Gibson system. All texture parameters were significantly associated with the Beagley-Gibson score. Among the parameters, the distance between primary lines (Distance) and the value of angle formed by intersection textures (Angle Max., Angle Diff.) were positively associated with the Beagley-Gibson score. However, there was a negative correlation between the number of grids (Grids), the number of angle (Angle Num.) and the Beagley-Gibson score. These texture parameters were also correlated with factors influencing skin aging such as sun exposure, age, smoking, drinking and body mass index. In multivariate analysis, Grids and Distance were mainly affected by age. But Angle Max. and Angle Diff. were mainly affected by sun exposure. It seemed that the skin surface morphologic parameters presented in our study reflect skin aging changes to some extent and could be used to describe skin aging using digital image processing. © 2011 John Wiley & Sons A/S.

Do Neurocognitive SCAT3 Baseline Test Scores Differ Between Footballers (Soccer) Living With and Without Disability? A Cross-Sectional Study.

PubMed

Weiler, Richard; van Mechelen, Willem; Fuller, Colin; Ahmed, Osman Hassan; Verhagen, Evert

2018-01-01

To determine if baseline Sport Concussion Assessment Tool, third Edition (SCAT3) scores differ between athletes with and without disability. Cross-sectional comparison of preseason baseline SCAT3 scores for a range of England international footballers. Team doctors and physiotherapists supporting England football teams recorded players' SCAT 3 baseline tests from August 1, 2013 to July 31, 2014. A convenience sample of 249 England footballers, of whom 185 were players without disability (male: 119; female: 66) and 64 were players with disability (male learning disability: 17; male cerebral palsy: 28; male blind: 10; female deaf: 9). Between-group comparisons of median SCAT3 total and section scores were made using nonparametric Mann-Whitney-Wilcoxon ranked-sum test. All footballers with disability scored higher symptom severity scores compared with male players without disability. Male footballers with learning disability demonstrated no significant difference in the total number of symptoms, but recorded significantly lower scores on immediate memory and delayed recall compared with male players without disability. Male blind footballers' scored significantly higher for total concentration and delayed recall, and male footballers with cerebral palsy scored significantly higher on balance testing and immediate memory, when compared with male players without disability. Female footballers with deafness scored significantly higher for total concentration and balance testing than female footballers without disability. This study suggests that significant differences exist between SCAT3 baseline section scores for footballers with and without disability. Concussion consensus guidelines should recognize these differences and produce guidelines that are specific for the growing number of athletes living with disability.

Repeat treatment with rifaximin improves irritable bowel syndrome-related quality of life: a secondary analysis of a randomized, double-blind, placebo-controlled trial.

PubMed

Cash, Brooks D; Pimentel, Mark; Rao, Satish S C; Weinstock, Leonard; Chang, Lin; Heimanson, Zeev; Lembo, Anthony

2017-09-01

Diarrhea-predominant irritable bowel syndrome (IBS-D) impairs patient quality of life (QOL). Rifaximin is an oral, nonsystemic antibiotic indicated for IBS-D. The objective of this secondary analysis was to evaluate rifaximin retreatment on IBS-related QOL in patients with IBS-D. Patients received open-label rifaximin 550 mg three times daily for 2 weeks. Clinical responders [simultaneously meeting weekly response criteria for abdominal pain (⩾30% improvement from baseline in mean weekly pain score) and stool consistency (⩾50% decrease from baseline in number of days/week with Bristol Stool Scale (BSS) type 6 or 7 stools) during ⩾2 of first 4 weeks posttreatment] who relapsed during an up to 18-week treatment-free observation phase were randomly assigned to receive two 2-week courses of double-blind rifaximin or placebo, separated by 10 weeks. A validated 34-item IBS-QOL questionnaire examined patient responses in 8 domains. The 2579 patients receiving open-label rifaximin experienced a mean improvement from baseline in IBS-QOL overall score of 54.9%. Responders to open-label rifaximin ( n = 1074 of 2438 evaluable; 44.1%) had significantly greater improvement from baseline in IBS-QOL overall and all eight subdomain scores, including dysphoria, food avoidance, interference with activity, body image, and sexual function versus nonresponders at 4 weeks posttreatment ( n = 1364; p < 0.001 for all comparisons). A significantly greater percentage of responders to open-label rifaximin achieved the minimally clinically important difference (MCID; ⩾14-point improvement from baseline) in the overall IBS-QOL score versus nonresponders [ n = 561 (52.2%) versus n = 287 (21.0%); p < 0.0001]. Among 636 patients with IBS-D relapse, the MCID in the overall IBS-QOL score was achieved by a significantly greater percentage of patients receiving double-blind rifaximin versus placebo (38.6% versus 29.6%, respectively; p = 0.009). Open-label and blinded retreatment with a short course (2 weeks) of rifaximin improved IBS-QOL in patients with IBS-D [ClinicalTrials.gov identifier: NCT01543178].

Blinded randomized controlled study of a web-based otoscopy simulator in undergraduate medical education.

PubMed

Stepniak, Camilla; Wickens, Brandon; Husein, Murad; Paradis, Josee; Ladak, Hanif M; Fung, Kevin; Agrawal, Sumit K

2017-06-01

OtoTrain is a Web-based otoscopy simulator that has previously been shown to have face and content validity. The objective of this study was to evaluate the effectiveness of this Web-based otoscopy simulator in teaching diagnostic otoscopy to novice learners STUDY DESIGN: Prospective, blinded randomized control trial. Second-year medical students were invited to participate in the study. A pretest consisted of a series of otoscopy videos followed by an open-answer format assessment pertaining to the characteristics and diagnosis of each video. Participants were then randomly divided into a control group and a simulator group. Following the pretest, both groups attended standard otology lectures, but the simulator group was additionally given unlimited access to OtoTrain for 1 week. A post-test was completed using a separate set of otoscopy videos. Tests were graded based on a comprehensive marking scheme. The pretest and post-test were anonymized, and the three evaluators were blinded to student allotment. A total of 41 medical students were enrolled in the study and randomized to the control group (n = 20) and the simulator group (n = 21). There was no significant difference between the two groups on their pretest scores. With the standard otology lectures, the control group had a 31% improvement in their post-test score (mean ± standard error of the mean, 30.4 ± 1.5) compared with their pretest score (23.3 ± 1.8) (P < .001). The simulator group had the addition of OtoTrain to the otology lectures, and their score improved by 71% on their post-test (37.8 ± 1.6) compared to their pretest (22.1 ± 1.9) (P < .001). Comparing the post-test results, the simulator group had a 24% higher score than the control group (P < .002). Inter-rater reliability between the blinded evaluators was excellent (r = 0.953, P < .001). The use of OtoTrain increased the diagnostic otoscopic performance in novice learners. OtoTrain may be an effective teaching adjunct for undergraduate medical students. 1b. Laryngoscope, 127:1306-1311, 2017. © 2016 The American Laryngological, Rhinological and Otological Society, Inc.

Relationships among Testing Medium, Test Performance, and Testing Time of High School Students Who Are Visually Impaired

ERIC Educational Resources Information Center

Erin, Jane N.; Hong, Sunggye; Schoch, Christina; Kuo, YaJu

2006-01-01

This study compared the test scores and time required by high school students who are blind, sighted, or have low vision to complete tests administered in written and oral formats. The quantitative results showed that the blind students performed better on multiple-choice tests in braille and needed more time while taking tests in braille. The…

Use of the Blind Learning Aptitude Test with Children in England and Wales and the United States.

ERIC Educational Resources Information Center

Mason, H. L.

1991-01-01

An 18-month study of the use of the Blind Learning Aptitude Test at schools for visually impaired children in England and Wales found the test to be culturally fair and appropriate for use with children for whom English is a second language. Scores are compared with standardization data for visually impaired children in the United States.…

Effect of Pumpkin Seed Oil on Hair Growth in Men with Androgenetic Alopecia: A Randomized, Double-Blind, Placebo-Controlled Trial

PubMed Central

Jeong, Dong Wook; Choi, Eun Jung; Kim, Yun Jin; Lee, Jeong Gyu; Yi, Yu Hyeon; Cha, Hyeong Soo

2014-01-01

Pumpkin seed oil (PSO) has been shown to block the action of 5-alpha reductase and to have antiandrogenic effects on rats. This randomized, placebo-controlled, double-blind study was designed to investigate the efficacy and tolerability of PSO for treatment of hair growth in male patients with mild to moderate androgenetic alopecia (AGA). 76 male patients with AGA received 400 mg of PSO per day or a placebo for 24 weeks. Change over time in scalp hair growth was evaluated by four outcomes: assessment of standardized clinical photographs by a blinded investigator; patient self-assessment scores; scalp hair thickness; and scalp hair counts. Reports of adverse events were collected throughout the study. After 24 weeks of treatment, self-rated improvement score and self-rated satisfaction scores in the PSO-treated group were higher than in the placebo group (P = 0.013, 0.003). The PSO-treated group had more hair after treatment than at baseline, compared to the placebo group (P < 0.001). Mean hair count increases of 40% were observed in PSO-treated men at 24 weeks, whereas increases of 10% were observed in placebo-treated men (P < 0.001). Adverse effects were not different in the two groups. PMID:24864154

Clinical assessment of patients with recalcitrant psoriasis in a randomized, observer-blind, vehicle-controlled trial using indigo naturalis.

PubMed

Lin, Yin-Ku; Chang, Chee-Jen; Chang, Ya-Ching; Wong, Wen-Rou; Chang, Shu-Chen; Pang, Jong-Hwei Su

2008-11-01

To evaluate the efficacy and safety of treatment with indigo naturalis in patients with recalcitrant plaque-type psoriasis. Randomized, observer-blind, vehicle-controlled, intrapatient comparison study. Ambulatory department of a hospital. Forty-two outpatients with chronic plaque psoriasis were enrolled in the study from May 1, 2004, to April 30, 2005. The patients applied either indigo naturalis ointment or vehicle ointment topically to each of 2 bilaterally symmetrical psoriatic plaque lesions for 12 weeks (depending on the date of enrollment in the study). The outcomes were assessed using the following criteria: the sum of erythema, scaling, and induration scores and the clearing percentage of the target plaque lesion assessed by 2 blinded observers. Significant reductions in the sum of scaling, erythema, and induration scores (P < .001) (mean score, 6.3 after indigo naturalis treatment vs 12.8 in control subjects) and plaque area percentage (P < .001) (mean percentage, 38.5% after indigo naturalis treatment vs 90% in controls) were achieved with topical application of indigo naturalis ointment. Approximately 31 of 42 patients (74%) experienced clearance or near clearance of their psoriasis in the indigo ointment-treated lesion. Topical indigo naturalis ointment was a novel, safe, and effective therapy for plaque-type psoriasis.

BEMER Therapy Combined with Physiotherapy in Patients with Musculoskeletal Diseases: A Randomised, Controlled Double Blind Follow-Up Pilot Study

PubMed Central

Gyulai, Franciska; Rába, Katalin; Baranyai, Ildikó; Berkes, Enikő; Bender, Tamás

2015-01-01

Background. This study evaluates the effect of adjuvant BEMER therapy in patients with knee arthrosis and chronic low back pain in a randomized double blind design. Methods. A total of 50 patients with chronic low back pain and 50 patients with osteoarthritis of knee took part in this study and were randomized into 4 groups. Hospitalized patients received a standardized physiotherapy package for 3 weeks followed by BEMER therapy or placebo. Results. In patients with low back pain, the comparison of the results obtained at the first and second visit showed a significant improvement in resting VAS scores and Fatigue Scale scores. The Oswestry scores and Quality of Life Scale scores showed no change. In patients with knee arthrosis, the comparison of the first and second measurements showed no significant improvement in the abovementioned parameters, while the comparison of the first and third scores revealed a significant improvement in the Fatigue Scale scores and in the vitality test on the Quality of Life Scale. Conclusions. Our study showed that BEMER physical vascular therapy reduced pain and fatigue in the short term in patients with chronic low back pain, while long-term therapy appears to be beneficial in patients with osteoarthritis of knee. PMID:26078768

Ordinal convolutional neural networks for predicting RDoC positive valence psychiatric symptom severity scores.

PubMed

Rios, Anthony; Kavuluru, Ramakanth

2017-11-01

The CEGS N-GRID 2016 Shared Task in Clinical Natural Language Processing (NLP) provided a set of 1000 neuropsychiatric notes to participants as part of a competition to predict psychiatric symptom severity scores. This paper summarizes our methods, results, and experiences based on our participation in the second track of the shared task. Classical methods of text classification usually fall into one of three problem types: binary, multi-class, and multi-label classification. In this effort, we study ordinal regression problems with text data where misclassifications are penalized differently based on how far apart the ground truth and model predictions are on the ordinal scale. Specifically, we present our entries (methods and results) in the N-GRID shared task in predicting research domain criteria (RDoC) positive valence ordinal symptom severity scores (absent, mild, moderate, and severe) from psychiatric notes. We propose a novel convolutional neural network (CNN) model designed to handle ordinal regression tasks on psychiatric notes. Broadly speaking, our model combines an ordinal loss function, a CNN, and conventional feature engineering (wide features) into a single model which is learned end-to-end. Given interpretability is an important concern with nonlinear models, we apply a recent approach called locally interpretable model-agnostic explanation (LIME) to identify important words that lead to instance specific predictions. Our best model entered into the shared task placed third among 24 teams and scored a macro mean absolute error (MMAE) based normalized score (100·(1-MMAE)) of 83.86. Since the competition, we improved our score (using basic ensembling) to 85.55, comparable with the winning shared task entry. Applying LIME to model predictions, we demonstrate the feasibility of instance specific prediction interpretation by identifying words that led to a particular decision. In this paper, we present a method that successfully uses wide features and an ordinal loss function applied to convolutional neural networks for ordinal text classification specifically in predicting psychiatric symptom severity scores. Our approach leads to excellent performance on the N-GRID shared task and is also amenable to interpretability using existing model-agnostic approaches. Copyright © 2017 Elsevier Inc. All rights reserved.

Tumor Cell-Free DNA Copy Number Instability Predicts Therapeutic Response to Immunotherapy.

PubMed

Weiss, Glen J; Beck, Julia; Braun, Donald P; Bornemann-Kolatzki, Kristen; Barilla, Heather; Cubello, Rhiannon; Quan, Walter; Sangal, Ashish; Khemka, Vivek; Waypa, Jordan; Mitchell, William M; Urnovitz, Howard; Schütz, Ekkehard

2017-09-01

Purpose: Chromosomal instability is a fundamental property of cancer, which can be quantified by next-generation sequencing (NGS) from plasma/serum-derived cell-free DNA (cfDNA). We hypothesized that cfDNA could be used as a real-time surrogate for imaging analysis of disease status as a function of response to immunotherapy and as a more reliable tool than tumor biomarkers. Experimental Design: Plasma cfDNA sequences from 56 patients with diverse advanced cancers were prospectively collected and analyzed in a single-blind study for copy number variations, expressed as a quantitative chromosomal number instability (CNI) score versus 126 noncancer controls in a training set of 23 and a blinded validation set of 33. Tumor biomarker concentrations and a surrogate marker for T regulatory cells (Tregs) were comparatively analyzed. Results: Elevated CNI scores were observed in 51 of 56 patients prior to therapy. The blinded validation cohort provided an overall prediction accuracy of 83% (25/30) and a positive predictive value of CNI score for progression of 92% (11/12). The combination of CNI score before cycle (Cy) 2 and 3 yielded a correct prediction for progression in all 13 patients. The CNI score also correctly identified cases of pseudo-tumor progression from hyperprogression. Before Cy2 and Cy3, there was no significant correlation for protein tumor markers, total cfDNA, or surrogate Tregs. Conclusions: Chromosomal instability quantification in plasma cfDNA can serve as an early indicator of response to immunotherapy. The method has the potential to reduce health care costs and disease burden for cancer patients following further validation. Clin Cancer Res; 23(17); 5074-81. ©2017 AACR . ©2017 American Association for Cancer Research.

Validity and reliability of global operative assessment of laparoscopic skills (GOALS) in novice trainees performing a laparoscopic cholecystectomy.

PubMed

Kramp, Kelvin H; van Det, Marc J; Hoff, Christiaan; Lamme, Bas; Veeger, Nic J G M; Pierie, Jean-Pierre E N

2015-01-01

Global Operative Assessment of Laparoscopic Skills (GOALS) assessment has been designed to evaluate skills in laparoscopic surgery. A longitudinal blinded study of randomized video fragments was conducted to estimate the validity and reliability of GOALS in novice trainees. In total, 10 trainees each performed 6 consecutive laparoscopic cholecystectomies. Sixty procedures were recorded on video. Video fragments of (1) opening of the peritoneum; (2) dissection of Calot's triangle and achievement of critical view of safety; and (3) dissection of the gallbladder from the liver bed were blinded, randomized, and rated by 2 consultant surgeons using GOALS. Also, a grade was given for overall competence. The correlation of GOALS with live observation Objective Structured Assessment of Technical Skills (OSATS) scores was calculated. Construct validity was estimated using the Friedman 2-way analysis of variance by ranks and the Wilcoxon signed-rank test. The interrater reliability was calculated using the absolute and consistency agreement 2-way random-effects model intraclass correlation coefficient. A high correlation was found between mean GOALS score (r = 0.879, p = 0.021) and mean OSATS score. The GOALS score increased significantly across the 6 procedures (p = 0.002). The trainees performed significantly better on their sixth when compared with their first cholecystectomy (p = 0.004). The consistency agreement interrater reliability was 0.37 for the mean GOALS score (p = 0.002) and 0.55 for overall competence (p < 0.001) of the 3 video fragments. The validity observed in this randomized blinded longitudinal study supports the existing evidence that GOALS is a valid tool for assessment of novice trainees. A relatively low reliability was found in this study. Copyright © 2014 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

Pain control after primary total knee replacement. A prospective randomised controlled trial of local infiltration versus single shot femoral nerve block.

PubMed

Ashraf, Anam; Raut, Videsh V; Canty, Stephen J; McLauchlan, George J

2013-10-01

We report a prospective blinded randomised trial of local infiltration versus femoral nerve block in patients undergoing primary total knee replacement (TKR), in accordance with the CONSORT statement 2010. Fifty patients in a teaching hospital were consented for the study. The study arms were intraoperative local anaesthesia (150ml 0.2% ropivacaine/1ml 1:1000 adrenaline/30mg ketolorac) and femoral nerve block (30ml 0.2% ropivacaine) with a primary outcome of pain score at 4h post operatively. Secondary outcomes were pain at 2h, pain scores before and after physiotherapy on day one, total opiate administered, time to physiotherapy goals and length of stay. Randomisation was by sealed envelope. The assessor was blinded and the patients partially blinded to the intervention. Ten patients were excluded, eight before randomisation. The trial is complete. Forty patients were analysed for the primary outcome measure. The local infiltration group had significantly lower pain scores at 4h post-operatively; mean [SD] score 2.1 [2.6] versus 6.8 [3.2], p<0.00001 and on post-operative day one prior to physiotherapy; mean score 2.4 [2.3] versus 4.4 [2.3], p<0.05. Total opiate use was also significantly lower in the local infiltration group; mean total 115 [50.3]mg versus 176.5 [103.5]mg, p<0.01. There was no difference in any other outcome. There were no harms as a result of either intervention. Intraoperative local infiltration gives superior pain relief compared to single shot femoral nerve block over the first 24h following primary TKR and minimises post-operative opiate use. Copyright © 2013 Elsevier B.V. All rights reserved.

Analysis of opioid-mediated analgesia in Phase III studies of methylnaltrexone for opioid-induced constipation in patients with chronic noncancer pain

PubMed Central

Webster, Lynn R; Brenner, Darren M; Barrett, Andrew C; Paterson, Craig; Bortey, Enoch; Forbes, William P

2015-01-01

Background Subcutaneous methylnaltrexone is efficacious and well tolerated for opioid-induced constipation (OIC) but may theoretically disrupt opioid-mediated analgesia. Methods Opioid use, pain intensity, and opioid withdrawal (Objective Opioid Withdrawal Scale [OOWS] and Subjective Opiate Withdrawal Scale [SOWS] scores) were reported in a randomized, double-blind trial with an open-label extension (RCT) and an open-label trial (OLT) evaluating safety in adults with chronic noncancer pain. In the RCT, patients taking ≥50 mg of oral morphine equivalents daily with <3 rescue-free bowel movements weekly received methyl naltrexone 12 mg once daily (n=150), every other day (n=148), or placebo (n=162) for 4 weeks, followed by open-label methylnaltrexone 12 mg (as needed [prn]; n=364) for 8 weeks. In the OLT, patients (n=1,034) on stable opioid doses with OIC received methylnaltrexone 12 mg prn for up to 48 weeks. Results Minimal fluctuations of median morphine equivalent dose from baseline (BL) were observed in the RCT double-blind period (BL, 154.8–161.0 mg/d; range, 137.1–168.0 mg/d), RCT open-label period (BL, 156.3–174.6; range, 144.0–180.0) and OLT (BL, 120 mg/d; range, 117.3–121.1 mg/d). No significant change from BL in pain intensity score occurred in any group at weeks 2 or 4 (both P≥0.1) of the RCT double-blind period, and scores remained stable during the open-label period and in the OLT (mean change, −0.2 to 0.1). Changes from BL in OOWS and SOWS scores during the double-blind period were not significantly impacted by methylnaltrexone exposure at weeks 2 or 4 (P>0.05 for all). Conclusion Methylnaltrexone did not affect opioid-mediated analgesia in patients with chronic noncancer pain and OIC. PMID:26586963

Exploration of exposure conditions with a novel wireless detector for bedside digital radiography

NASA Astrophysics Data System (ADS)

Bosmans, Hilde; Nens, Joris; Delzenne, Louis; Marshall, Nicholas; Pauwels, Herman; De Wever, Walter; Oyen, Raymond

2012-03-01

We propose, apply and validate an optimization scheme for a new wireless CsI based DR detector in combination with a regular mobile X-ray system for bedside imaging applications. Three different grids were tested in this combination. Signal-difference-to-noise was investigated in two ways, using a 1mm Cu piece in combination with different thicknesses of PMMA and by means of the CDRAD phantom using 10 images per condition and an automated evaluation method. A Figure of Merit (FOM), namely SDNR2/Imparted Energy, was calculated for a large range of exposure conditions, without and with grid in place. Misalignment of the grids was evaluated via the same FOMs. This optimization study was validated with comparative X-ray acquisitions performed on dead bodies. An experienced radiologist scored the quality of several specific aspects for all these exposures. Signal difference to noise ratios measured with the Cu method correlated well with the threshold contrasts from the CDRAD analysis (R2 > 0.9). The analysis showed optimal FOM with detector air kerma rates as typically used in clinical practice. Lower tube voltages provide higher FOM than the higher values but their practical use depends on the limitations of X-ray tubes, linked to patient motion artefacts. The use of high resolution grids should be encouraged, as the FOM increases with 47% at 75kV. These scores from the Visual grading study confirmed the results obtained with the FOM. The switch to (wireless) DR technology for bedside imaging could benefit from devices to improve grid positioning or any scatter reduction technique.

Antiscatter grid use in pediatric digital tomosynthesis imaging†

PubMed Central

King, Jenna M.; Reed, Martin

2011-01-01

The objective of this study was to assess the effect of antiscatter grid use on tomosynthesis image quality. We performed an observer study that rated the image quality of digital tomosynthesis scout radiographs and slice images of a Leeds TO.20 contrast‐detail test object embedded in acrylic with and without a grid. We considered 10, 15, 20 and 25 cm of acrylic to represent the wide range of patient thicknesses encountered in pediatric imaging. We also acquired and rated images without a grid at an increased patient dose. The readers counted the total number of visible details in each image as a measure of relative image quality. We observed that the antiscatter grid improves tomosynthesis image quality compared to the grid‐out case, which received image quality scores similar to grid‐in radiography. Our results suggest that, in order to achieve the best image quality in exchange for the increase in patient dose, it may often be appropriate to include an antiscatter grid for pediatric tomosynthesis imaging, particularly if the patient thickness is greater than 10 cm. PACS number: 87.57.‐s PMID:22089021

Helping Struggling Students: The Impact of Three Instructional Interventions on College Students' Exam Scores and Exam-Skipping Behavior

ERIC Educational Resources Information Center

Thomas, Nichole Gibbs; Thomas, Antonio Lamar

2018-01-01

Whether instructional-communication feedback sent to struggling students and succeeding students following course exams would significantly increase their exam scores and significantly decrease their exam-skipping behavior relative to students in the control group was investigated. An experimenter-blind study utilizing feedback and the…

Ziprasidone and amisulpride effectively treat negative symptoms of schizophrenia: results of a 12-week, double-blind study.

PubMed

Olié, Jean-Pierre; Spina, Edoardo; Murray, Stephen; Yang, Ruoyong

2006-05-01

We compared the efficacy of ziprasidone and amisulpride in the treatment of negative symptoms and overall psychopathology in subjects who had chronic schizophrenia with predominantly negative symptoms. This multicentre, 12-week, double-blind study randomly assigned subjects with predominantly negative-symptom schizophrenia [i.e. Positive and Negative Syndrome Scale (PANSS) Negative Subscale score >or=6 points greater than Positive Subscale score] to ziprasidone (40-80 mg b.i.d.; n=60) or amisulpride (50-100 mg b.i.d.; n=63). The primary efficacy variable was the change from baseline in PANSS Negative Subscale score. Secondary efficacy variables included change in scores for PANSS Total, Global Assessment of Functioning, Brief Psychiatric Rating Scale derived from PANSS Total and Core, Clinical Global Impression (CGI)-Severity and CGI-Improvement. For the change in PANSS Negative Subscale score, a ratio to assess the equivalence of the treatment groups was calculated from the least squares mean changes from baseline, with equivalence claimed if the lower limit of the 95% confidence interval of the ratio exceeded 0.60. Mean daily dose, adjusted for differential numbers of subjects and differential days between visits, was 118.0 mg for ziprasidone and 144.7 mg for amisulpride. Mean PANSS Negative Subscale scores improved over the 12-week treatment period for intent-to-treat subjects, evaluable subjects (subjects with >or=4 weeks of double-blind treatment and no protocol deviations) and completers in both treatment groups. Ziprasidone demonstrated efficacy comparable to amisulpride in improving negative symptoms and global psychopathology. The groups demonstrated comparable improvements in secondary efficacy variables. Both agents were generally well tolerated, with comparably low incidences of movement disorders. In subjects with negative symptom-prominent schizophrenia, ziprasidone in mean daily doses of 118 mg was equivalent to amisulpride in mean daily doses of 148 mg in ameliorating negative symptoms and comparable in improving overall psychopathology and global illness severity.

A preliminary study of the impact of a handover cognitive aid on clinical reasoning and information transfer.

PubMed

Weiss, Matthew J; Bhanji, Farhan; Fontela, Patricia S; Razack, Saleem I

2013-08-01

To assess the impact of a written cognitive aid on expressed clinical reasoning and quantity and the accuracy of information transfer during resident doctor handover. This study was a randomised controlled trial in an academic paediatric intensive care unit (PICU) of 20 handover events (10 events per group) from residents in their first PICU rotation using a written handover cognitive aid (intervention) or standard practice (control). Before rounds, an investigator generated a reference standard of the handover event by completing a handover aid. Resident handovers were then audio-recorded and transcribed by a blinded research assistant. The content of this transcript was inserted into a blank handover aid. A blinded content expert scored the quantity and accuracy of the information in this aid according to predetermined criteria and these information scores (ISs) were compared with the reference standard. The same expert also blindly scored the transcripts in five domains of clinical reasoning and effectiveness: (i) effective summary of events; (ii) expressed understanding of the care plan; (iii) presentation clarity; (iv) organisation; (v) overall handover effectiveness. Differences between intervention and control groups were assessed using the Mann-Whitney test and multivariate linear regression. The intervention group had total ISs that more closely approximated the reference standard (81% versus 61%; p < 0.01). The intervention group had significantly higher clinical reasoning scores when compared by total score (21.1 versus 15.9 points; p = 0.01) and in each of the five domains. No difference was observed in the duration of handover between groups (7.4 versus 7.7 minutes; p = 0.97). Using a novel scoring system, our simple handover cognitive aid was shown to improve information transfer and resident expression of clinical reasoning without prolonging the handover duration. © 2013 John Wiley & Sons Ltd.

Nonablative Fractional Laser Resurfacing for Acne Scarring in Patients With Fitzpatrick Skin Phototypes IV-VI.

PubMed

Alexis, Andrew F; Coley, Marcelyn K; Nijhawan, Rajiv I; Luke, Janiene D; Shah, Sejal K; Argobi, Yahya A; Nodzenski, Michael; Veledar, Emir; Alam, Murad

2016-03-01

There is a paucity of studies investigating laser resurfacing in Fitzpatrick skin phototypes (SPT) IV to VI. To assess the efficacy and safety of fractional nonablative laser resurfacing in the treatment of acne scarring in patients with SPT IV to VI. The authors conducted a randomized, investigator-blinded and rater-blinded, split-face comparative study of adults with SPT IV to VI and facial acne scars treated with 2 different density settings and the same fluence. Quantitative global scarring grading system (QGSGS) scores were significantly improved from baseline at 16 and 24 weeks (p = .0277). Improvements in QGSGS scores after higher and lower density treatments were statistically similar (p = .96). The live-blinded dermatologist, the blinded dermatologist photoraters, and the patients rated scars as being significantly more improved by visual analog scale at weeks 16 and 24 compared with baseline (p < .001) for both treatment densities. Five of 7 and 3 of 7 patients in the higher and lower density group, respectively, experienced mild or moderate hyperpigmentation as an investigator observed site reaction. The nonablative 1550-nm fractional laser is safe and efficacious in treating acne scaring in Fitzpatrick skin types IV to VI. Self-limited postinflammatory hyperpigmentation was a common occurrence, especially with higher treatment densities.

Analysis of an infinite array of rectangular microstrip patches with idealized probe feeds

NASA Technical Reports Server (NTRS)

Pozar, D. M.; Schaubert, D. H.

1984-01-01

A solution is presented to the problem of an infinite array of microstrip patches fed by idealized current probes. The input reflection coefficient is calculated versus scan angle in an arbitrary scan plane, and the effects of substrate parameters and grid spacing are considered. It is pointed out that even when a Galerkin method is used the impedance matrix is not symmetric due to phasing through a unit cell, as required for scanning. The mechanism by which scan blindness can occur is discussed. Measurement results are presented for the reflection coefficient magnitude variation with angle for E-plane, H-plane, and D-plane scans, for various substrate parameters. Measured results from waveguide simulators are also presented, and the scan blindness phenomenon is observed and discussed in terms of forced surface waves and a modified grating lobe diagram.

Olfactory Performance in a Large Sample of Early-Blind and Late-Blind Individuals.

PubMed

Sorokowska, Agnieszka

2016-10-01

Previous examinations of olfactory sensitivity in blind people have produced contradictory findings. Thus, whether visual impairment is associated with increased olfactory abilities is unclear. In the present investigation, I aimed to resolve the existing questions via a relatively large-scale study comprising early-blind (N = 43), and late-blind (N = 41) and sighted (N = 84) individuals matched in terms of gender and age. To compare the results with those of previous studies, I combined data from a free odor identification test, extensive psychophysical testing (Sniffin' Sticks test), and self-assessed olfactory performance. The analyses revealed no significant effects of sight on olfactory threshold, odor discrimination, cued identification, or free identification scores; neither was the performance of the early-blind and late-blind participants significantly different. Additionally, the self-assessed olfactory abilities of the blind people were no different than those of the sighted people. These results suggest that sensory compensation in visually impaired is not pronounced with regards to olfactory abilities as measured by standardized smell tests. © The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Multiscale image processing and antiscatter grids in digital radiography.

PubMed

Lo, Winnie Y; Hornof, William J; Zwingenberger, Allison L; Robertson, Ian D

2009-01-01

Scatter radiation is a source of noise and results in decreased signal-to-noise ratio and thus decreased image quality in digital radiography. We determined subjectively whether a digitally processed image made without a grid would be of similar quality to an image made with a grid but without image processing. Additionally the effects of exposure dose and of a using a grid with digital radiography on overall image quality were studied. Thoracic and abdominal radiographs of five dogs of various sizes were made. Four acquisition techniques were included (1) with a grid, standard exposure dose, digital image processing; (2) without a grid, standard exposure dose, digital image processing; (3) without a grid, half the exposure dose, digital image processing; and (4) with a grid, standard exposure dose, no digital image processing (to mimic a film-screen radiograph). Full-size radiographs as well as magnified images of specific anatomic regions were generated. Nine reviewers rated the overall image quality subjectively using a five-point scale. All digitally processed radiographs had higher overall scores than nondigitally processed radiographs regardless of patient size, exposure dose, or use of a grid. The images made at half the exposure dose had a slightly lower quality than those made at full dose, but this was only statistically significant in magnified images. Using a grid with digital image processing led to a slight but statistically significant increase in overall quality when compared with digitally processed images made without a grid but whether this increase in quality is clinically significant is unknown.

Macroscopic cartilage repair scoring of defect fill, integration and total points correlate with corresponding items in histological scoring systems - a study in adult sheep.

PubMed

Goebel, L; Orth, P; Cucchiarini, M; Pape, D; Madry, H

2017-04-01

To correlate osteochondral repair assessed by validated macroscopic scoring systems with established semiquantitative histological analyses in an ovine model and to test the hypothesis that important macroscopic individual categories correlate with their corresponding histological counterparts. In the weight-bearing portion of medial femoral condyles (n = 38) of 19 female adult Merino sheep (age 2-4 years; weight 70 ± 20 kg) full-thickness chondral defects were created (size 4 × 8 mm; International Cartilage Repair Society (ICRS) grade 3C) and treated with Pridie drilling. After sacrifice, 1520 blinded macroscopic observations from three observers at 2-3 time points including five different macroscopic scoring systems demonstrating all grades of cartilage repair where correlated with corresponding categories from 418 blinded histological sections. Categories "defect fill" and "total points" of different macroscopic scoring systems correlated well with their histological counterparts from the Wakitani and Sellers scores (all P ≤ 0.001). "Integration" was assessed in both histological scoring systems and in the macroscopic ICRS, Oswestry and Jung scores. Here, a significant relationship always existed (0.020 ≤ P ≤ 0.049), except for Wakitani and Oswestry (P = 0.054). No relationship was observed for the "surface" between histology and macroscopy (all P > 0.05). Major individual morphological categories "defect fill" and "integration", and "total points" of macroscopic scoring systems correlate with their corresponding categories in elementary and complex histological scoring systems. Thus, macroscopy allows to precisely predict key histological aspects of articular cartilage repair, underlining the specific value of macroscopic scoring for examining cartilage repair. Copyright © 2016 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

A randomized trial comparing the efficacy and safety of intravitreal triamcinolone with standard care to treat vision loss associated with macular Edema secondary to branch retinal vein occlusion: the Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) study report 6.

PubMed

Scott, Ingrid U; Ip, Michael S; VanVeldhuisen, Paul C; Oden, Neal L; Blodi, Barbara A; Fisher, Marian; Chan, Clement K; Gonzalez, Victor H; Singerman, Lawrence J; Tolentino, Michael

2009-09-01

To compare the efficacy and safety of 1-mg and 4-mg doses of preservative-free intravitreal triamcinolone with standard care (grid photocoagulation in eyes without dense macular hemorrhage and deferral of photocoagulation until hemorrhage clears in eyes with dense macular hemorrhage) for eyes with vision loss associated with macular edema secondary to branch retinal vein occlusion (BRVO). Multicenter, randomized clinical trial of 411 participants. Main Outcome Measure Gain in visual acuity letter score of 15 or more from baseline to month 12. Twenty-nine percent, 26%, and 27% of participants achieved the primary outcome in the standard care, 1-mg, and 4-mg groups, respectively. None of the pairwise comparisons between the 3 groups was statistically significant at month 12. The rates of elevated intraocular pressure and cataract were similar for the standard care and 1-mg groups, but higher in the 4-mg group. There was no difference identified in visual acuity at 12 months for the standard care group compared with the triamcinolone groups; however, rates of adverse events (particularly elevated intraocular pressure and cataract) were highest in the 4-mg group. Application to Clinical Practice Grid photocoagulation as applied in the SCORE Study remains the standard care for patients with vision loss associated with macular edema secondary to BRVO who have characteristics similar to participants in the SCORE-BRVO trial. Grid photocoagulation should remain the benchmark against which other treatments are compared in clinical trials for eyes with vision loss associated with macular edema secondary to BRVO. Trial Registration clinicaltrials.gov Identifier: NCT00105027.

Antimicrobial liquid formulations: a blind taste comparison of three brands of penicillin VK and three brands of amoxicillin.

PubMed

Chan, D S; Demers, D M; Bass, J W

1996-02-01

To rate the perception of taste, texture, smell and aftertaste of various brands of penicillin VK and amoxicillin. Oral, liquid formulations of three brands of penicillin VK (PenVee K, V-Cillin-K, VeeTids) and three brands of amoxicillin (Amoxil, Trimox, Wymox) were evaluated for smell, texture, taste, and aftertaste by 30 volunteers in a blind study. Each category was scored on a scale of 1 to 5. The order in which the drugs were sampled was randomized for the first three groups of five participants. The order then was reversed for the remaining three groups of participants. A 537-bed US Army teaching hospital. Participants included 30 healthy adult volunteers from the Departments of Pediatrics, Nursing, and Pharmacy. Drugs received cumulative scores in each category, as well as an overall total score ranking. The data were analyzed using one-way ANOVA for repeated measures with a post hoc Duncan's multiple range test to determine significant differences between individual means. Overall, Trimox and Amoxil scored significantly higher than the remaining drugs. Although V-Cillin-K scored highest in the smell category, its score was significantly below those of Trimox and Amoxil in the texture, taste, aftertaste, and overall categories. Overall, the three penicillin VK solutions scored lower than the three amoxicillin suspensions, with PenVee K ranking the lowest. Among the penicillin VK solutions, V-Cillin-K scored significantly higher overall than the other two penicillin VK solutions. Overall, all three amoxicillin oral, liquid suspensions that were studied scored significantly better than the three penicillin VK solutions.

Rotigotine improves restless legs syndrome: a 6-month randomized, double-blind, placebo-controlled trial in the United States.

PubMed

Hening, Wayne A; Allen, Richard P; Ondo, William G; Walters, Arthur S; Winkelman, John W; Becker, Philip; Bogan, Richard; Fry, June M; Kudrow, David B; Lesh, Kurt W; Fichtner, Andreas; Schollmayer, Erwin

2010-08-15

This randomized, double-blinded, placebo-controlled trial (NCT00135993) assessed efficacy and safety of the dopamine agonist rotigotine in the treatment of idiopathic restless legs syndrome (RLS) over a 6-month maintenance period. A total of 505 eligible participants with moderate to severe RLS (IRLS sum score >or= 15) were randomly assigned to five groups to receive either placebo or rotigotine (0.5, 1, 2, or 3 mg/24 hr) delivered by once-daily transdermal patch (fixed-dose regimen). The two co-primary efficacy parameters decreased from baseline to end of maintenance in IRLS sum score and in clinical global impressions (CGI-1) score. On both primary measures, 2 and 3 mg/24 hr rotigotine was superior to placebo (P < 0.001). Adjusted treatment differences to placebo for the IRLS sum score were -4.5 (95% CI: -6.9, -2.2) for 2 mg/24 hr rotigotine, -5.2 (95% CI: -7.5, -2.9) for 3 mg/24 hr rotigotine, and for CGI item 1 -0.65 (95% CI: -1.0, -0.3) and -0.9 (95% CI: -1.3, -0.5) for the 2 and 3 mg/24 hr doses, respectively. Skin reactions (27%) and known dopaminergic side effects such as nausea (18.1%) and headache (11.6%) were mostly mild or moderate in rotigotine subjects. Rotigotine transdermal patches releasing 2 to 3 mg/24 hr significantly reduced the severity of RLS symptoms. Treatment efficacy was maintained throughout the 6-month double-blind period.

Open-label 24-week extension study of edaravone (MCI-186) in amyotrophic lateral sclerosis.

PubMed

2017-10-01

We aimed to explore the longer-term efficacy and safety of edaravone in an active-treatment extension period following the double-blind period of the second phase III study. Patients who met all the following criteria (scores ≥2 points on all 12 items of the revised amyotrophic lateral sclerosis functional rating scale [ALSFRS-R], forced vital capacity ≥80%, definite or probable ALS, and disease duration ≤2 years) were randomised to 60 mg intravenous edaravone or placebo for six cycles in the double-blind period, and then offered the opportunity to proceed to this 24-week open-label extension period. One hundred and twenty-three of 137 patients continued to the extension period: 65 edaravone-edaravone (E-E group) and 58 placebo-edaravone (P-E group). Change (mean ± standard deviation; SD) in the ALSFRS-R score from baseline in the double-blind period was -4.1 ± 3.4 and -6.9 ± 5.1 in the E-E group and P-E group, respectively, while it was -8.0 ± 5.6 in the E-E group and -10.9 ± 6.9 in the P-E group over the whole 48-week period. The ALSFRS-R score changed almost linearly throughout Cycles 1-12 in the E-E group. The most commonly reported adverse events were constipation, dysphagia, and contusion. There was no sudden deterioration in the ALSFRS-R score of the E-E group. No safety concerns related to edaravone were detected.

A randomized, double-blind, placebo-controlled trial of oral Matricaria recutita (chamomile) extract therapy for generalized anxiety disorder.

PubMed

Amsterdam, Jay D; Li, Yimei; Soeller, Irene; Rockwell, Kenneth; Mao, Jun James; Shults, Justine

2009-08-01

We conducted a randomized, double-blind, placebo-controlled efficacy and tolerability trial of Matricaria recutita (chamomile) extract therapy in patients with mild to moderate generalized anxiety disorder (GAD). We hypothesized that chamomile would be superior to placebo in reducing GAD symptoms with a comparable tolerability profile. Sixty-one outpatients with mild to moderate GAD were enrolled, and 57 were randomized to either double-blind chamomile extract (n = 28) or placebo therapy (n = 29) for 8 weeks. The study was powered to detect a statistically significant and clinically meaningful group difference in change over time in total Hamilton Anxiety Rating (HAM-A) scores. Secondary outcomes included change in the Beck Anxiety Inventory, Psychological Well Being, and Clinical Global Impression Severity scores and the proportion of patients with 50% reduction or more in baseline HAM-A score. We observed a significantly greater reduction in mean total HAM-A score during chamomile versus placebo therapy (P = 0.047). Although the study was not powered to identify small to moderate differences in secondary outcomes, we observed a positive change in all secondary outcomes in the same direction as the primary outcome measure. One patient in each treatment group discontinued therapy for adverse events. The proportion of patients experiencing 0, 1, 2, or 3 adverse events or more was not significantly different between groups (P = 0.417). This is the first controlled clinical trial of chamomile extract for GAD. The results suggest that chamomile may have modest anxiolytic activity in patients with mild to moderate GAD. Future studies are needed to replicate these observations.

Memory for environmental sounds in sighted, congenitally blind and late blind adults: evidence for cross-modal compensation.

PubMed

Röder, Brigitte; Rösler, Frank

2003-10-01

Several recent reports suggest compensatory performance changes in blind individuals. It has, however, been argued that the lack of visual input leads to impoverished semantic networks resulting in the use of data-driven rather than conceptual encoding strategies on memory tasks. To test this hypothesis, congenitally blind and sighted participants encoded environmental sounds either physically or semantically. In the recognition phase, both conceptually as well as physically distinct and physically distinct but conceptually highly related lures were intermixed with the environmental sounds encountered during study. Participants indicated whether or not they had heard a sound in the study phase. Congenitally blind adults showed elevated memory both after physical and semantic encoding. After physical encoding blind participants had lower false memory rates than sighted participants, whereas the false memory rates of sighted and blind participants did not differ after semantic encoding. In order to address the question if compensatory changes in memory skills are restricted to critical periods during early childhood, late blind adults were tested with the same paradigm. When matched for age, they showed similarly high memory scores as the congenitally blind. These results demonstrate compensatory performance changes in long-term memory functions due to the loss of a sensory system and provide evidence for high adaptive capabilities of the human cognitive system.

Search for β2 Adrenergic Receptor Ligands by Virtual Screening via Grid Computing and Investigation of Binding Modes by Docking and Molecular Dynamics Simulations

PubMed Central

Bai, Qifeng; Shao, Yonghua; Pan, Dabo; Zhang, Yang; Liu, Huanxiang; Yao, Xiaojun

2014-01-01

We designed a program called MolGridCal that can be used to screen small molecule database in grid computing on basis of JPPF grid environment. Based on MolGridCal program, we proposed an integrated strategy for virtual screening and binding mode investigation by combining molecular docking, molecular dynamics (MD) simulations and free energy calculations. To test the effectiveness of MolGridCal, we screened potential ligands for β2 adrenergic receptor (β2AR) from a database containing 50,000 small molecules. MolGridCal can not only send tasks to the grid server automatically, but also can distribute tasks using the screensaver function. As for the results of virtual screening, the known agonist BI-167107 of β2AR is ranked among the top 2% of the screened candidates, indicating MolGridCal program can give reasonable results. To further study the binding mode and refine the results of MolGridCal, more accurate docking and scoring methods are used to estimate the binding affinity for the top three molecules (agonist BI-167107, neutral antagonist alprenolol and inverse agonist ICI 118,551). The results indicate agonist BI-167107 has the best binding affinity. MD simulation and free energy calculation are employed to investigate the dynamic interaction mechanism between the ligands and β2AR. The results show that the agonist BI-167107 also has the lowest binding free energy. This study can provide a new way to perform virtual screening effectively through integrating molecular docking based on grid computing, MD simulations and free energy calculations. The source codes of MolGridCal are freely available at http://molgridcal.codeplex.com. PMID:25229694

Treatment of Posttraumatic Stress Disorder Using the Traditional Japanese Herbal Medicine Saikokeishikankyoto: A Randomized, Observer-Blinded, Controlled Trial in Survivors of the Great East Japan Earthquake and Tsunami

PubMed Central

GunFan, Shen; Takahashi, Satomi; Monma, Yasutake; Kuroda, Hitoshi; Tanaka, Junichi; Nara, Masayuki; Kagaya, Yutaka; Ishii, Tadashi; Kohzuki, Masahiro; Iwasaki, Koh

2014-01-01

The Great East Japan earthquake and tsunami caused immense damage over a wide area of eastern Japan. Hence, many survivors are at high risk for posttraumatic stress disorder (PTSD). This randomized, observer-blinded, controlled trial examined the efficacy and safety of the traditional Japanese herbal formula saikokeishikankyoto (SKK) in the treatment of PTSD among survivors of this disaster. Forty-three participants with an Impact of Event Scale-Revised (IES-R) score ≥ 25 were randomized into SKK (n = 21) and control (n = 22) groups. The primary endpoint was the change in IES-R scores from baseline till after 2 weeks of treatment. Intergroup statistical comparisons were performed. The magnitude of changes in total IES-R scores differed significantly between the two groups (P < 0.001). Post hoc analysis showed that the total IES-R score improved significantly in the SKK group from 49.6 ± 11.9 to 25.5 ± 17.0 (P < 0.001). Subscale scores improved significantly in the SKK group (avoidance, P = 0.003; hyperarousal, P < 0.001; intrusion, P < 0.001). Two-week treatment with SKK significantly improved IES-R scores among PTSD patients. This traditional medicine may be a valid choice for the treatment of psychological and physical symptoms in PTSD patients. PMID:24790634

Racemic versus l-epinephrine aerosol in the treatment of postextubation laryngeal edema: results from a prospective, randomized, double-blind study.

PubMed

Nutman, J; Brooks, L J; Deakins, K M; Baldesare, K K; Witte, M K; Reed, M D

1994-10-01

To determine whether any advantage exists using racemic epinephrine instead of the more potent and less expensive levo(1)-epinephrine in the treatment of postextubation laryngeal edema. Prospective, double-blind, randomized study. Pediatric intensive care unit in a university teaching hospital. Twenty-eight patients with stridor during the immediate postextubation period. After extubation, patients demonstrating clinically important stridor were randomized in a double-blind fashion to receive an aerosol containing either 2.25% racemic or 1% l-epinephrine. Heart rate, respiratory rate, blood pressure, and stridor score were determined at 20, 40, and 60 mins and 4 and 8 hrs after the initial aerosol administration. Patients in both groups demonstrated significant (p < .01) reductions in stridor score after aerosol administration. No significant differences were observed between treatment groups in improvement in stridor score or the number of subsequent aerosols required. Respiratory rate decreased significantly 40 and 60 mins after l-epinephrine but not after racemic epinephrine. No significant change in heart rate or blood pressure occurred after aerosol administration in either group. These data suggest that aerosolized l-epinephrine is as effective as aerosolized racemic epinephrine in the treatment of postextubation laryngeal edema without additional adverse side effects. When dosed appropriately, l-epinephrine is a less expensive and more widely available alternative to racemic epinephrine for the treatment of postextubation laryngeal edema.

Donepezil for treatment of cognitive dysfunction in children with Down syndrome aged 10-17.

PubMed

Kishnani, Priya S; Heller, James H; Spiridigliozzi, Gail A; Lott, Ira; Escobar, Luis; Richardson, Sharon; Zhang, Richard; McRae, Thomas

2010-12-01

The objective of this 10-week, randomized, double-blind, placebo-controlled multicenter study was to assess the efficacy and safety of donepezil for the treatment of cognitive dysfunction exhibited by children with Down syndrome (DS). Intervention comprised donepezil (2.5-10 mg/day) in children (aged 10-17 years) with DS of mild-to-moderate severity. The primary measures were the Vineland-II Adaptive Behavior Scales (VABS-II) Parent/Caregiver Rating Form (PCRF) the sum of nine subdomain standardized scores and standard safety measures. Secondary measures included the VABS-II/PCRF scores on the following domains and their respective individual subdomains: Communication (receptive, expressive, and written); Daily Living Skills (personal, domestic, and community); Socialization (interpersonal relationships, play and leisure time, and coping skills), and scores on the Test of Verbal Expression and Reasoning, a subject-performance-based measure of expressive language. At baseline, 129 participants were assigned treatment with donepezil or placebo. During the double-blind phase, VABS II/PCRF sum of the nine subdomain standardized scores, called v-scores, improved significantly from baseline in both groups (P < 0.0001), with no significant between-group differences. This trial failed to demonstrate any benefit for donepezil versus placebo in children and adolescents with DS, although donepezil appeared to be well tolerated. © 2010 Wiley-Liss, Inc.

Benchmarking management practices in Australian public healthcare.

PubMed

Agarwal, Renu; Green, Roy; Agarwal, Neeru; Randhawa, Krithika

2016-01-01

The purpose of this paper is to investigate the quality of management practices of public hospitals in the Australian healthcare system, specifically those in the state-managed health systems of Queensland and New South Wales (NSW). Further, the authors assess the management practices of Queensland and NSW public hospitals jointly and globally benchmark against those in the health systems of seven other countries, namely, USA, UK, Sweden, France, Germany, Italy and Canada. In this study, the authors adapt the unique and globally deployed Bloom et al. (2009) survey instrument that uses a "double blind, double scored" methodology and an interview-based scoring grid to measure and internationally benchmark the management practices in Queensland and NSW public hospitals based on 21 management dimensions across four broad areas of management - operations, performance monitoring, targets and people management. The findings reveal the areas of strength and potential areas of improvement in the Queensland and NSW Health hospital management practices when compared with public hospitals in seven countries, namely, USA, UK, Sweden, France, Germany, Italy and Canada. Together, Queensland and NSW Health hospitals perform best in operations management followed by performance monitoring. While target management presents scope for improvement, people management is the sphere where these Australian hospitals lag the most. This paper is of interest to both hospital administrators and health care policy-makers aiming to lift management quality at the hospital level as well as at the institutional level, as a vehicle to consistently deliver sustainable high-quality health services. This study provides the first internationally comparable robust measure of management capability in Australian public hospitals, where hospitals are run independently by the state-run healthcare systems. Additionally, this research study contributes to the empirical evidence base on the quality of management practices in the Australian public healthcare systems of Queensland and NSW.

Oxytocin may be useful to increase trust in others and decrease disruptive behaviours in patients with Prader-Willi syndrome: a randomised placebo-controlled trial in 24 patients

PubMed Central

2011-01-01

Background Prader-Willi syndrome (PWS) is a complex neurodevelopmental genetic disorder with hypothalamic dysfunction, early morbid obesity with hyperphagia, and specific psychiatric phenotypes including cognitive and behavioural problems, particularly disruptive behaviours and frequent temper outbursts that preclude socialization. A deficit in oxytocin (OT)-producing neurons of the hypothalamic paraventricular nucleus has been reported in these patients. Methods In a double-blind, randomised, placebo-controlled study, 24 adult patients with PWS received a single intranasal administration of 24 IU of OT or placebo and were tested 45 min later on social skills. Behaviours were carefully monitored and scored using an in-house grid as follows: over the two days before drug administration, on the half-day following administration, and over the subsequent two days. All patients were in a dedicated PWS centre with more than ten years of experience. Patients are regularly admitted to this controlled environment. Results Patients with PWS who received a single intranasal administration of OT displayed significantly increased trust in others (P = 0.02) and decreased sadness tendencies (P = 0.02) with less disruptive behaviour (P = 0.03) in the two days following administration than did patients who received placebo. In the half-day following administration, we observed a trend towards less conflict with others (p = 0.07) in the OT group compared with the placebo group. Scores in tests assessing social skills were not significantly different between the two groups. Conclusions This study needs to be reproduced and adapted. It nevertheless opens new perspectives for patients with PWS and perhaps other syndromes with behavioural disturbances and obesity. Trial registration number ClinicalTrials.gov: NCT01038570 PMID:21702900

Oxytocin may be useful to increase trust in others and decrease disruptive behaviours in patients with Prader-Willi syndrome: a randomised placebo-controlled trial in 24 patients.

PubMed

Tauber, Maïthe; Mantoulan, Carine; Copet, Pierre; Jauregui, Joseba; Demeer, Genevieve; Diene, Gwenaëlle; Rogé, Bernadette; Laurier, Virginie; Ehlinger, Virginie; Arnaud, Catherine; Molinas, Catherine; Thuilleaux, Denise

2011-06-24

Prader-Willi syndrome (PWS) is a complex neurodevelopmental genetic disorder with hypothalamic dysfunction, early morbid obesity with hyperphagia, and specific psychiatric phenotypes including cognitive and behavioural problems, particularly disruptive behaviours and frequent temper outbursts that preclude socialization. A deficit in oxytocin (OT)-producing neurons of the hypothalamic paraventricular nucleus has been reported in these patients. In a double-blind, randomised, placebo-controlled study, 24 adult patients with PWS received a single intranasal administration of 24 IU of OT or placebo and were tested 45 min later on social skills. Behaviours were carefully monitored and scored using an in-house grid as follows: over the two days before drug administration, on the half-day following administration, and over the subsequent two days. All patients were in a dedicated PWS centre with more than ten years of experience. Patients are regularly admitted to this controlled environment. Patients with PWS who received a single intranasal administration of OT displayed significantly increased trust in others (P = 0.02) and decreased sadness tendencies (P = 0.02) with less disruptive behaviour (P = 0.03) in the two days following administration than did patients who received placebo. In the half-day following administration, we observed a trend towards less conflict with others (p = 0.07) in the OT group compared with the placebo group. Scores in tests assessing social skills were not significantly different between the two groups. This study needs to be reproduced and adapted. It nevertheless opens new perspectives for patients with PWS and perhaps other syndromes with behavioural disturbances and obesity. ClinicalTrials.gov: NCT01038570.

[Comparison of Preferential Hyperacuity Perimeter (PHP) test and Amsler grid test in the diagnosis of different stages of age-related macular degeneration].

PubMed

Kampmeier, J; Zorn, M M; Lang, G K; Botros, Y T; Lang, G E

2006-09-01

Age-related macular degeneration (ARMD) is the leading cause of blindness in people over 65 years of age. A rapid loss of vision occurs especially in cases with choroidal neovascularisation. Early detection of ARMD and timely treatment are mandatory. We have prospectively studied the results of two diagnostic self tests for the early detection of metamorphopsia and scotoma, the PHP test and the Amsler grid test, in different stages of ARMD. Patients with ARMD and best corrected visual acuity of 6/30 or better (Snellen charts) were examined with a standardised protocol, including supervised Amsler grid examination and PHP, a new device for metamorphopsia or scotoma measurement, based on the hyperacuity phenomenon in the central 14 degrees of the visual field. The stages of ARMD were independently graded in a masked fashion by stereoscopic ophthalmoscopy, stereoscopic fundus colour photographs, fluorescein angiography, and OCT. The patients were subdivided into 3 non-neovascular groups [early, late (RPE atrophy > 175 microm) and geographic atrophy], a neovascular group (classic and occult CNV) and an age-matched control group (healthy volunteers). 140 patients, with ages ranging from 50 to 90 years (median 68 years), were included in the study. Best corrected visual acuity ranged from 6/30 to 6/6 with a median of 6/12. 95 patients were diagnosed as non-neovascular ARMD. Thirty eyes had early ARMD (9 were tested positive by the PHP test and 9 by the Amsler grid test), and 50 late ARMD (positive: PHP test 23, Amsler grid test 26). The group with geographic atrophy consisted of 15 eyes (positive: PHP test 13, Amsler grid test 10). Forty-five patients presented with neovascular ARMD (positive: PHP test 38, Amsler grid test 36), 34 volunteers served as control group (positive: PHP test 1, Amsler grid test 5). The PHP and Amsler grid tests revealed comparable results detecting metamorphopsia and scotoma in early ARMD (30 vs. 30 %) and late ARMD (46 vs. 52 %). However, the PHP test more often revealed disease-related functional changes in the groups of geographic atrophy (87 vs. 67 %) and neovascular ARMD (84 vs. 80 %). This implies that the PHP and Amsler grid self tests are useful tools for detection of ARMD and that the PHP test has a greater sensitivity in the groups of geographic atrophy and neovascular AMD.

A Randomized Placebo-Controlled Double-Blind Study Evaluating the Time Course of Response to Methylphenidate Hydrochloride Extended-Release Capsules in Children with Attention-Deficit/Hyperactivity Disorder

PubMed Central

Greenhill, Laurence L.; Nordbrock, Earl; Connor, Daniel F.; Kollins, Scott H.; Adjei, Akwete; Childress, Ann; Stehli, Annamarie; Kupper, Robert J.

2014-01-01

Abstract Objective: The purpose of this study was to assess the time of onset and time course of efficacy over 12.0 hours of extended-release multilayer bead formulation of methylphenidate (MPH-MLR) compared with placebo in children 6–12 years of age with attention-deficit/hyperactivity disorder (ADHD) in a laboratory school setting. Methods: This randomized double-blind placebo-controlled study included children 6–12 years of age with ADHD. Enrolled children went through four study phases: 1) Screening period (≤4 weeks) and a 2 day medication washout period; 2) open-label period with dose initiation of MPH-MLR 15 mg daily and individual dose optimization treatment period (2–4 weeks); 3) double-blind crossover period in which participants were randomized to sequences (1 week each) of placebo and the optimized MPH-MLR dose given daily; and 4) follow-up safety call. Analog classroom time course evaluations were performed at the end of each double-blind week. The primary efficacy end-point was the mean of the on-treatment/postdose Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP)-Total scores over time points collected 1.0–12.0 hours after dosing. End-points were evaluated using a mixed-effects analysis of covariance. Results: The evaluable population included 20 participants. The least-squares mean postdose SKAMP-Total score was higher for placebo than for MPH-MLR (2.18 vs. 1.32, respectively; p=0.0001), indicating fewer symptoms with MPH-MLR therapy than with placebo. No difference in SKAMP-Total score between participants who received sequence 1 or sequence 2 was noted. From each of hours 1.0–12.0, least-squares mean SKAMP-Total score was significantly lower for those receiving MPH-MLR than for those receiving placebo (p≤0.0261). Neither serious adverse events nor new or unexpected safety findings were noted during the study. Conclusions: MPH-MLR showed a significant decrease in SKAMP scores compared with placebo in children with ADHD 6–12 years of age, indicating a decrease in ADHD symptoms. The estimated onset was observed within 1.0 hour, and duration was measured to 12.0 hours postdose. Trial registration: ClinicalTrials.gov Identifier: NCT01269463 PMID:25470572

Blind system identification of two-thermocouple sensor based on cross-relation method.

PubMed

Li, Yanfeng; Zhang, Zhijie; Hao, Xiaojian

2018-03-01

In dynamic temperature measurement, the dynamic characteristics of the sensor affect the accuracy of the measurement results. Thermocouples are widely used for temperature measurement in harsh conditions due to their low cost, robustness, and reliability, but because of the presence of the thermal inertia, there is a dynamic error in the dynamic temperature measurement. In order to eliminate the dynamic error, two-thermocouple sensor was used to measure dynamic gas temperature in constant velocity flow environments in this paper. Blind system identification of two-thermocouple sensor based on a cross-relation method was carried out. Particle swarm optimization algorithm was used to estimate time constants of two thermocouples and compared with the grid based search method. The method was validated on the experimental equipment built by using high temperature furnace, and the input dynamic temperature was reconstructed by using the output data of the thermocouple with small time constant.

Blind system identification of two-thermocouple sensor based on cross-relation method

NASA Astrophysics Data System (ADS)

Li, Yanfeng; Zhang, Zhijie; Hao, Xiaojian

2018-03-01

In dynamic temperature measurement, the dynamic characteristics of the sensor affect the accuracy of the measurement results. Thermocouples are widely used for temperature measurement in harsh conditions due to their low cost, robustness, and reliability, but because of the presence of the thermal inertia, there is a dynamic error in the dynamic temperature measurement. In order to eliminate the dynamic error, two-thermocouple sensor was used to measure dynamic gas temperature in constant velocity flow environments in this paper. Blind system identification of two-thermocouple sensor based on a cross-relation method was carried out. Particle swarm optimization algorithm was used to estimate time constants of two thermocouples and compared with the grid based search method. The method was validated on the experimental equipment built by using high temperature furnace, and the input dynamic temperature was reconstructed by using the output data of the thermocouple with small time constant.

Factors associated with vision-related quality of life among the adult population living in Nagorno Karabagh.

PubMed

Harutyunyan, T; Giloyan, A; Petrosyan, V

2017-12-01

Visual impairment and blindness are major public health problems causing significant suffering, disability, loss of productivity, and diminishing quality of life for millions of people. This study explored the factors associated with the overall vision-related quality of life (VRQoL) and its different domains in the adult population of Nagorno Karabakh and assessed the independent contribution of specific eye diseases to VRQoL. A cross-sectional study. We conducted interviewer-administered survey along with free eye screenings among adult residents of Hadrut and Martuni regions of Nagorno Karabakh (Artsakh) in 2014-2015. The study questionnaire included questions about sociodemographic characteristics, non-communicable diseases, use of eye care services, visual acuity, eye diseases, and VRQoL. National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) was used to assess VRQoL. In total, 531 adults participated in the study. The mean age of participants was 60.1 years (standard deviation [SD] = 13.7), ranging from 18 to 90 years. The majority of participants were female (71.4%). The most frequently diagnosed eye disorder was cataract (33.8%). The prevalence of moderate and severe visual impairment was 7.0% and 0.8%, respectively. Almost 2.8% (15) of participants were blind. The mean global score of VFQ-25 in all study participants was 71.1 ± 19.28 (SD), whereas the mean global scores of VFQ-25 among not visually impaired, visually impaired, and blind participants were 74.0 ± 16.47 (SD), 51.7 ± 21.77 (SD), and 30.9 ± 20.2 (SD), respectively. In the adjusted linear regression model having moderate/severe visual impairment or blindness, age, socio-economic status, and having eye diseases such as glaucoma and cataract were significantly associated with VFQ-25 global score. The subscales of near vision, distance vision, peripheral vision, role difficulties, and mental health had significant associations with severe/moderate visual impairment in the adjusted analysis. After adjusting for visual impairment and demographic variables, participants with cataract and glaucoma were found to have statistically significant lower subscale scores than those without eye disease. Our data suggest that visual impairment was associated with lower scores of VRQoL. The strength of that association correlated with the increase in the level of visual impairment (from moderate/severe impairment to blindness). VRQoL was also shown to be affected by age, socio-economic status, and having eye diseases such as glaucoma and cataract. Further actions of remediation of visual impairment in this population are warranted. Copyright © 2017 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

Scientific Visualization Made Easy for the Scientist

NASA Astrophysics Data System (ADS)

Westerhoff, M.; Henderson, B.

2002-12-01

amirar is an application program used in creating 3D visualizations and geometric models of 3D image data sets from various application areas, e.g. medicine, biology, biochemistry, chemistry, physics, and engineering. It has demonstrated significant adoption in the market place since becoming commercially available in 2000. The rapid adoption has expanded the features being requested by the user base and broadened the scope of the amira product offering. The amira product offering includes amira Standard, amiraDevT, used to extend the product capabilities by users, amiraMolT, used for molecular visualization, amiraDeconvT, used to improve quality of image data, and amiraVRT, used in immersive VR environments. amira allows the user to construct a visualization tailored to his or her needs without requiring any programming knowledge. It also allows 3D objects to be represented as grids suitable for numerical simulations, notably as triangular surfaces and volumetric tetrahedral grids. The amira application also provides methods to generate such grids from voxel data representing an image volume, and it includes a general-purpose interactive 3D viewer. amiraDev provides an application-programming interface (API) that allows the user to add new components by C++ programming. amira supports many import formats including a 'raw' format allowing immediate access to your native uniform data sets. amira uses the power and speed of the OpenGLr and Open InventorT graphics libraries and 3D graphics accelerators to allow you to access over 145 modules, enabling you to process, probe, analyze and visualize your data. The amiraMolT extension adds powerful tools for molecular visualization to the existing amira platform. amiraMolT contains support for standard molecular file formats, tools for visualization and analysis of static molecules as well as molecular trajectories (time series). amiraDeconv adds tools for the deconvolution of 3D microscopic images. Deconvolution is the process of increasing image quality and resolution by computationally compensating artifacts of the recording process. amiraDeconv supports 3D wide field microscopy as well as 3D confocal microscopy. It offers both non-blind and blind image deconvolution algorithms. Non-blind deconvolution uses an individual measured point spread function, while non-blind algorithms work on the basis of only a few recording parameters (like numerical aperture or zoom factor). amiraVR is a specialized and extended version of the amira visualization system which is dedicated for use in immersive installations, such as large-screen stereoscopic projections, CAVEr or Holobenchr systems. Among others, it supports multi-threaded multi-pipe rendering, head-tracking, advanced 3D interaction concepts, and 3D menus allowing interaction with any amira object in the same way as on the desktop. With its unique set of features, amiraVR represents both a VR (Virtual Reality) ready application for scientific and medical visualization in immersive environments, and a development platform that allows building VR applications.

Western Wind Data Set | Grid Modernization | NREL

Science.gov Websites

replicates the stochastic nature of wind power plant output. NREL modeled hysteresis around wind turbine cut where wind speeds are often near wind turbine cut-out (~25 m/s), SCORE output does not replicate the Vestas V90). The hysteresis-corrected SCORE is an attempt to put the wind turbine hysteresis at cut-out

High-dose transdermal nicotine in Parkinson's disease patients: a randomized, open-label, blinded-endpoint evaluation phase 2 study.

PubMed

Villafane, G; Thiriez, C; Audureau, E; Straczek, C; Kerschen, P; Cormier-Dequaire, F; Van Der Gucht, A; Gurruchaga, J-M; Quéré-Carne, M; Evangelista, E; Paul, M; Defer, G; Damier, P; Remy, P; Itti, E; Fénelon, G

2018-01-01

Studies of the effects of nicotine on motor symptoms in Parkinson's disease (PD) brought out discordant results. The aim of the present study was to evaluate the efficacy and safety of high doses of transdermal nicotine on motor symptoms in PD. Forty PD patients were randomly assigned to a treated and untreated arm in an open-label study. Treated patients received increasing doses of nicotine to reach 90 mg/day by 11 weeks. This dosage was maintained for 28 weeks (W39) and then reduced over 6 weeks. Final evaluation was performed 6 weeks after washout. The main outcome measure was the OFF-DOPA Unified Parkinson's Disease Rating Scale (UPDRS) motor score measured on video recordings by raters blinded to the medication status of the patients. There was no significant difference in OFF-DOPA UPDRS motor scores between the nicotine-treated and non-treated groups, neither at W39 (19.4 ± 9.3 vs. 21.5 ± 14.2) nor considering W39 differences from baseline (-1.5 ± 12.1 vs. +0.9 ± 12.1). The 39-item Parkinson's disease questionnaire scores decreased in nicotine-treated patients and increased in non-treated patients, but the difference was not significant. Overall tolerability was acceptable, and 12/20 treated patients reached the maximal dosage. High doses of transdermal nicotine were tolerated, but our study failed to demonstrate significant improvement in UPDRS motor scores. Improvement in unblinded secondary outcomes (UPDRS-II, UPDRS-IV, doses of l-DOPA equivalents) suggest a possible benefit for patients treated with nicotine, which should be confirmed in larger double blind, placebo-controlled studies. © 2017 EAN.

A clinical study to evaluate the efficacy of ELA-Max (4% liposomal lidocaine) as compared with eutectic mixture of local anesthetics cream for pain reduction of venipuncture in children.

PubMed

Eichenfield, Lawrence F; Funk, Ann; Fallon-Friedlander, Sheila; Cunningham, Bari B

2002-06-01

A double-randomized, blinded crossover trial was performed to assess the efficacy of ELA-Max (4% liposomal lidocaine) as compared with eutectic mixture of local anesthetics (EMLA) for pain relief during pediatric venipuncture procedures. Safety was assessed by evaluation for topical or systemic effects and measurement of serum lidocaine concentrations. A total of 120 children who were scheduled for repeat venipuncture for non-study-related reasons at 2 sites participated in the study. Patients were doubly randomized to treatment regimen (study medication application time of either 30 or 60 minutes) and to the order of application of the topical anesthetics for each venipuncture. The primary outcome measures were the child's rating of pain immediately after the venipuncture procedures using a 100-mm visual analog scale (VAS) tool and the parent's and blinded research observer's Observed Behavioral Distress scores. Both ELA-Max and EMLA seemed to alleviate venipuncture pain. There was no clinically or statistically significant difference in the patient VAS scores within the 30-minute or 60-minute treatment groups, and there was no clinical or statistical difference in VAS scores between the 30-minute ELA-Max treatment without occlusion and the 60-minute EMLA treatment with occlusion. There were no clinically or statistically significant differences between treatment with ELA-Max and EMLA in parental or blinded researcher Observed Behavioral Distress scores, the most frequent response at any observation time being "no distress." This study demonstrates that a 30-minute application of ELA-Max without occlusion is as safe and as effective for ameliorating pain associated with venipuncture as a 60-minute application of the prescription product EMLA requiring occlusion.

A comparison of the fascia iliaca block to the lumbar plexus block in providing analgesia following arthroscopic hip surgery: A randomized controlled clinical trial.

PubMed

Badiola, Ignacio; Liu, Jiabin; Huang, Stephanie; Kelly, John D; Elkassabany, Nabil

2018-05-31

This randomized controlled single blinded clinical trial compared the fascia iliaca block (FIB) and the lumbar plexus block (LPB) in patients with moderate to severe pain following hip arthroscopic surgery. Single blinded randomized trial. Postoperative recovery area, postoperative days 0 and 1. Fifty patients undergoing hip arthroscopy were approached in the Post Anesthesia Care Unit (PACU) if they had moderate to severe pain (defined as > or equal 4/10 on the numeric rating scale). Twenty-five patients were allocated to the FIB and twenty-five patients to the LPB. Fascia iliaca block or lumbar plexus block. A blinded observer recorded pain scores just prior to the block, 15 min following the block (primary endpoint), and then every 15 min for 2 h (or until the patient was discharged). Total PACU time and opioid use were recorded. Pain scores and analgesic use on postoperative day (POD) 0, and POD 1 were recorded. At 24 h post block the Quality of Recovery 9 questionnaire was administered. The mean pre-block pain scores were comparable between the two groups (P = 0.689). There was no difference in mean post block pain scores between the two groups at 15 min (P = 0.054). In the PACU patients who underwent a LPB consumed less opioids compared to FIB patients (P = 0.02), however no differences were noted between the two groups in PACU length of stay, or POD 0 or 1 opioid use. A fascia iliaca block is not inferior to a lumbar plexus block in reducing PACU pain scores in patients with moderate to severe pain following hip arthroscopic surgery and is a viable option to help manage postoperative pain following hip arthroscopic surgery. Copyright © 2018. Published by Elsevier Inc.

Association between disease-specific quality-of-life and magnetic resonance imaging outcomes in a clinical trial of prolotherapy for knee osteoarthritis

PubMed Central

Rabago, David; Kijowski, Richard; Woods, Michael; Patterson, Jeffrey J.; Mundt, Marlon; Zgierska, Aleksandra; Grettie, Jessica; Lyftogt, John; Fortney, Luke

2013-01-01

Objective To assess the relationship between knee osteoarthritis (KOA)-specific quality-of-life (QoL) and intra-articular cartilage volume (CV) in participants treated with prolotherapy. KOA is characterized by CV loss and multifactorial pain. Prolotherapy is an injection therapy reported to improve KOA-related QoL compared to blinded saline injections and at-home exercise but the mechanism of action is unknown. Design Two-arm (Prolotherapy, Control), partially blinded, controlled trial. Setting Outpatient. Participants 37 adults with ≥3 months of symptomatic KOA. Intervention Prolotherapy: 5 monthly injection sessions; Control: blinded saline injections or at-home exercise. Outcome Measures Primary: KOA-specific QoL scores (baseline, 5, 9, 12, 26, 52 weeks; Western Ontario McMaster University Osteoarthritis Index, WOMAC). Secondary: KOA-specific pain, stiffness, function (WOMAC subscales), magnetic resonance imaging (MRI)-assessed CV (baseline, 52 weeks). Results Knee-specific QoL improvement among Prolotherapy participants exceeded that of Controls (17.6±3.2 versus 8.6±5.0 points, p=0.05) at 52 weeks. Both groups lost CV over time (p<0.05); no between-group differences were noted (p=0.98). While Prolotherapy participants lost CV at varying rates, those who lost the least CV (“Stable CV”) had the greatest improvement in pain scores. Among Prolotherapy, but not Control participants, the change in CV and the change in pain (but not stiffness or function) scores were correlated; each 1% CV loss was associated with 2.7% less improvement in pain score (p<0.05). Conclusions Prolotherapy resulted in safe, substantial improvement in KOA-specific QoL compared to Control over 52-weeks. Among prolotherapy participants, but not Controls, MRI-assessed CV change (CV stability) predicted pain severity score change, suggesting prolotherapy may have pain-specific disease-modifying effect. Further research is warranted. PMID:23850615

Effect of a Medicinal Agaricus blazei Murill-Based Mushroom Extract, AndoSan™, on Symptoms, Fatigue and Quality of Life in Patients with Ulcerative Colitis in a Randomized Single-Blinded Placebo Controlled Study.

PubMed

Therkelsen, Stig Palm; Hetland, Geir; Lyberg, Torstein; Lygren, Idar; Johnson, Egil

2016-01-01

Ingestion of AndoSan™, based on the mushroom Agaricus blazei Murill, has previously been shown to exhibit anti-inflammatory effects because of reduction of pro-inflammatory cytokines in healthy individuals and patients with ulcerative colitis. In this randomized single-blinded placebo controlled study we examined whether intake of AndoSan™ also resulted in clinical effects. 50 patients with symptomatic ulcerative colitis were block-randomized and blinded for oral daily intake of AndoSan™ or placebo for the 21 days' experimental period. The patients reported scores for symptoms, fatigue and health related quality of life (HRQoL) at days 0, 14 and 21. Fecal calprotectin and general blood parameters were also analyzed. In the AndoSan™ group (n = 24) symptoms improved from baseline (day 0) to days 14 and 21, with respective mean scores (95% CI) of 5.88 (4.92-6.83), 4.71 (3.90-5.52) (p = 0.002) and 4.50 (3.70-5.30) (p = 0.001). Corresponding improved mean scores (±SD) for total fatigue were 16.6 (5.59), 14.1 (4.50) (p = 0.001) and 15.1 (4.09) (p = 0.023). These scores in the placebo group (n = 26) were not improved. When comparing the two study groups using mixed model statistics, we found significant better scores for the AndoSan™-patients. HRQoL for dimensions bodily pain, vitality, social functioning and mental health improved in the AndoSan™ group. There were no alterations in general blood samples and fecal calprotectin. Beneficiary effects on symptoms, fatigue and HRQoL from AndoSan™ consumption were demonstrated in this per-protocol study, supporting its use as a supplement to conventional medication for patients with mild to moderate symptoms from ulcerative colitis. The patients did not report any harms or unintended effects of AndoSan™ in this study. ClinicalTrials.gov NCT01496053.

Effect of omega-3 and ascorbic acid on inflammation markers in depressed shift workers in Shahid Tondgoyan Oil Refinery, Iran: a randomized double-blind placebo-controlled study

PubMed Central

Khajehnasiri, Farahnaz; Mortazavi, Seyed Bagher; Allameh, Abdolamir; Akhondzadeh, Shahin

2013-01-01

The present study aimed to assess the effect of supplementation of omega-3 and/or vitamin C on serum interleukin-6 and high sensitivity C-reactive protein concentration and depression scores among shift workers in Shahid Tondgoyan oil refinery. The study design was randomized, double-blind, placebo-controlled, parallel trial. Totally 136 shift workers with a depression score ≥10 in 21-item Beck Depression Rating Scale were randomly assigned to receive omega-3 (180 mg eicosapentaenoate acid and 120 mg docosahexaenoic acid) or/and vitamin C 250 mg or placebo twice daily (with the same taste and shape as omega-3 and vitamin C) for 60 days in four groups. Depression score, interleukin-6 and high sensitivity C-reactive protein were measured at baseline and after 60 days. This study showed that supplementation of omega-3 plus vitamin C is associated with a decrease in depression score (p<0.05). Supplementation of omega-3 without vitamin C, is associated with a reduction in depression score (p<0.0001) and high sensitivity C-reactive protein concentration (p<0.01). Therefore omega-3 supplementation showed a better effect on reducing depression score and high sensitivity C-reactive protein, but supplementation of vitamin C along with omega-3 did not have significant effect on change in C-reactive protein level compared to omega-3 alone. (Registration number: IRCT201202189056N1) PMID:23874068

Zone calculation as a tool for assessing performance outcome in laparoscopic suturing.

PubMed

Buckley, Christina E; Kavanagh, Dara O; Nugent, Emmeline; Ryan, Donncha; Traynor, Oscar J; Neary, Paul C

2015-06-01

Simulator performance is measured by metrics, which are valued as an objective way of assessing trainees. Certain procedures such as laparoscopic suturing, however, may not be suitable for assessment under traditionally formulated metrics. Our aim was to assess if our new metric is a valid method of assessing laparoscopic suturing. A software program was developed to order to create a new metric, which would calculate the percentage of time spent operating within pre-defined areas called "zones." Twenty-five candidates (medical students N = 10, surgical residents N = 10, and laparoscopic experts N = 5) performed the laparoscopic suturing task on the ProMIS III(®) simulator. New metrics of "in-zone" and "out-zone" scores as well as traditional metrics of time, path length, and smoothness were generated. Performance was also assessed by two blinded observers using the OSATS and FLS rating scales. This novel metric was evaluated by comparing it to both traditional metrics and subjective scores. There was a significant difference in the average in-zone and out-zone scores between all three experience groups (p < 0.05). The new zone metrics scores correlated significantly with the subjective-blinded observer scores of OSATS and FLS (p = 0.0001). The new zone metric scores also correlated significantly with the traditional metrics of path length, time, and smoothness (p < 0.05). The new metric is a valid tool for assessing laparoscopic suturing objectively. This could be incorporated into a competency-based curriculum to monitor resident progression in the simulated setting.

'Benifuuki' green tea containing o-methylated catechin reduces symptoms of Japanese cedar pollinosis: a randomized, double-blind, placebo-controlled trial.

PubMed

Masuda, Sawako; Maeda-Yamamoto, Mari; Usui, Satoko; Fujisawa, Takao

2014-06-01

Methylated catechin, one of the active ingredients in green tea, has been reported to ameliorate allergic reactions. We evaluated the efficacy of 'Benifuuki' green tea, which contains O-methylated epigallocatechin-3-O-[3-O-methyl] gallate (O-methylated EGCG), in alleviating Japanese cedar pollinosis (JCP). The study was a double-blind, randomized, placebo-controlled trial. The subjects with JCP were randomly assigned to drink 700ml of 'Benifuuki' green tea containing O-methylated EGCG or 'Yabukita' green tea (not containing O-methylated EGCG) as a placebo every day from December 2007 through March 2008, which includes the pollen season. The primary outcome was the area under the curve (AUC) of symptom scores during the peak pollen season. Fifty-one adults with JCP participated in the study. Twenty-six subjects were assigned to 'Benifuuki' and 25 to 'Yabukita'. The AUC of symptom score during the peak pollen season in the 'Benifuuki' group was significantly smaller than in the 'Yabukita' group for each of runny nose, itchy eyes, tearing, total nasal symptom score, total ocular symptom score, nasal symptom-medication score and ocular symptom-medication score. The total QOL-related questionnaire score for one week in the peak pollen season was significantly better in the 'Benifuuki' group. Increase in the peripheral eosinophil count in response to pollen exposure was suppressed in the 'Benifuuki' group. No adverse events were reported in either group. 'Benifuuki' green tea containing a large amount of O-methylated EGCG reduced the symptoms of JCP and has potential as a complementary/alternative medicine for treating seasonal allergic rhinitis.

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.

Topical tocopherol for treatment of reticular oral lichen planus: a randomized, double-blind, crossover study.

PubMed

Bacci, C; Vanzo, V; Frigo, A C; Stellini, E; Sbricoli, L; Valente, M

2017-01-01

This randomized, double-blind, placebo-controlled crossover study assessed the efficacy of topical tocopherol acetate compared with placebo in easing oral discomfort in patients with reticular oral lichen planus (ROLP). Thirty-four patients with clinically diagnosed and histologically confirmed ROLP were randomly assigned to two groups, which received first one of two treatments (treatment 1 or 2) for a month, then the other (treatment 2 or 1) for another month, with a two-week washout between them. One treatment contained tocopherol acetate and the other only liquid paraffin. The primary outcome was less discomfort, measured on a visual analog scale (VAS). Secondary outcomes were as follows: length of striae measured and photographed at each follow-up; surface area of lesions; and a modified Thongprasom score. No statistically significant differences emerged between the two treatments (1 vs 2) in terms of VAS scores (P > 0.05; 0.8624) or length of striae (P = 0.0883). Significant differences were seen for surface area of lesions (P < 0.05, P = 0.0045) and modified Thongprasom scores (P = 0.0052). The two treatments differed only in terms of the surface area of the lesions and Thongprasom scores, not in VAS scores for discomfort or the length of patients' striae. Topical tocopherol proved effective in the treatment of ROLP. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Complex antioxidants in a randomized single-blinded study of memory in seniors.

PubMed

Summers, William K; Martin, Roy L; Liu, Yimeng; Peña, Bernice; Marsh, Gary M

2018-04-01

Oxidative injury to the brain and aging are theoretical co-causes of Alzheimer's Disease (AD). Amyloid plaques and tangles are then secondary phenomenon. The preclinical state would then be 'normal' elderly. A potent complex antioxidant (antiOx) was tested against a popular one-a-day multivitamin (mV) in a randomized single blind design in 'normal' senior subjects over 6 months. Memory testing was done at baseline, 1, 3, and 6 months. The generalized estimating equation (GEE) approach was used to compare the change score of NLT 100 and 20 WR between two groups over time. Analysis of the antiOx group (30 subjects) demonstrated significant improvement in declarative memory (change score for NLT 100 at month 6 = 6.36 p < 0.0001) and working memory (change score for 20 WR at month 6 = 3.23, p < 0.0001). A change-score analysis over 6 months suggests possible neurogenesis in the antiOx group. The mV group (33 subjects) had a change score of the NLT 100 and 20WR on the sixth month of 2.20 and 0.32 (p = 0.07, 0.35). A complex antioxidant blend, sold as an over-the-counter (OTC) supplement, can improve memory in elder subjects. Antioxidants may be beneficial in AD and other neurodegerative diseases.

The Combination of Preoperative Bone Marrow Lesions and Partial-Thickness Cartilage Loss Did Not Result in Inferior Outcomes After Medial Unicompartmental Knee Arthroplasty.

PubMed

Berend, Keith R; Lombardi, Adolph V; Jacobs, Cale A

2017-10-01

The purpose of this study is to compare patient-reported outcomes and revision rates between medial unicompartmental knee arthroplasty (UKA) patients based on the presence of medial bone marrow lesions (BMLs) and/or partial- vs full-thickness cartilage loss. BMLs were graded on preoperative magnetic resonance imaging (MRI) findings from 174 UKAs performed between 2009 and 2013 using the MRI Osteoarthritis Knee Score criteria by a single evaluator blinded to the patient's outcome. A second evaluator blinded to the MRI findings and postoperative outcomes assessed medial joint space present on both weight-bearing and valgus stress radiographs. Preoperative and postoperative Knee Society Knee Scores, Pain Scores, and Function Scores were then compared between 4 groups of patients: patients with BML with either partial- or full-thickness cartilage loss, and patients without BML with either partial- or full-thickness cartilage loss. In total, 152 of 174 (87%) patients had minimum 2-year follow-up. One patient in the no BML/full-thickness loss group was converted to total knee arthroplasty secondary to arthrofibrosis; however, there were no statistical differences in revision rate between the 4 groups as no other revisions were performed (P = .61). Similarly, preoperative and postoperative Knee Society Knee Scores, Pain Scores, and Function Scores did not differ between groups, nor did postoperative University of California, Los Angeles activity scores. Medial tibial BMLs were not associated with inferior outcomes, either in patients with partial- or full-thickness cartilage loss. Although the current results do not allow for the presence of preoperative BML to be considered an indication for UKA, these results definitively support that BMLs are not a contraindication for medial UKA. Copyright © 2017 Elsevier Inc. All rights reserved.

Using deconvolution to improve the metrological performance of the grid method

NASA Astrophysics Data System (ADS)

Grédiac, Michel; Sur, Frédéric; Badulescu, Claudiu; Mathias, Jean-Denis

2013-06-01

The use of various deconvolution techniques to enhance strain maps obtained with the grid method is addressed in this study. Since phase derivative maps obtained with the grid method can be approximated by their actual counterparts convolved by the envelope of the kernel used to extract phases and phase derivatives, non-blind restoration techniques can be used to perform deconvolution. Six deconvolution techniques are presented and employed to restore a synthetic phase derivative map, namely direct deconvolution, regularized deconvolution, the Richardson-Lucy algorithm and Wiener filtering, the last two with two variants concerning their practical implementations. Obtained results show that the noise that corrupts the grid images must be thoroughly taken into account to limit its effect on the deconvolved strain maps. The difficulty here is that the noise on the grid image yields a spatially correlated noise on the strain maps. In particular, numerical experiments on synthetic data show that direct and regularized deconvolutions are unstable when noisy data are processed. The same remark holds when Wiener filtering is employed without taking into account noise autocorrelation. On the other hand, the Richardson-Lucy algorithm and Wiener filtering with noise autocorrelation provide deconvolved maps where the impact of noise remains controlled within a certain limit. It is also observed that the last technique outperforms the Richardson-Lucy algorithm. Two short examples of actual strain fields restoration are finally shown. They deal with asphalt and shape memory alloy specimens. The benefits and limitations of deconvolution are presented and discussed in these two cases. The main conclusion is that strain maps are correctly deconvolved when the signal-to-noise ratio is high and that actual noise in the actual strain maps must be more specifically characterized than in the current study to address higher noise levels with Wiener filtering.

Reiki therapy for postoperative oral pain in pediatric patients: pilot data from a double-blind, randomized clinical trial.

PubMed

Kundu, Anjana; Lin, Yuting; Oron, Assaf P; Doorenbos, Ardith Z

2014-02-01

To examine the effects of Reiki as an adjuvant therapy to opioid therapy for postoperative pain control in pediatric patients. This was a double-blind, randomized controlled study of children undergoing dental procedures. Participants were randomly assigned to receive either Reiki therapy or the control therapy (sham Reiki) preoperatively. Postoperative pain scores, opioid requirements, and side effects were assessed. Family members were also asked about perioperative care satisfaction. Multiple linear regressions were used for analysis. Thirty-eight children participated. The blinding procedure was successful. No statistically significant difference was observed between groups on all outcome measures. Our study provides a successful example of a blinding procedure for Reiki therapy among children in the perioperative period. This study does not support the effectiveness of Reiki as an adjuvant therapy to opioid therapy for postoperative pain control in pediatric patients. Copyright © 2013 Elsevier Ltd. All rights reserved.

Reiki therapy for postoperative oral pain in pediatric patients: Pilot data from a double-blind, randomized clinical trial

PubMed Central

Kundu, Anjana; Lin, Yuting; Oron, Assaf P.; Doorenbos, Ardith Z.

2014-01-01

Purpose To examine the effects of Reiki as an adjuvant therapy to opioid therapy for postoperative pain control in pediatric patients. Methods This was a double-blind, randomized controlled study of children undergoing dental procedures. Participants were randomly assigned to receive either Reiki therapy or the control therapy (sham Reiki) preoperatively. Postoperative pain scores, opioid requirements, and side effects were assessed. Family members were also asked about perioperative care satisfaction. Multiple linear regressions were used for analysis. Results Thirty-eight children participated. The blinding procedure was successful. No statistically significant difference was observed between groups on all outcome measures. Implications Our study provides a successful example of a blinding procedure for Reiki therapy among children in the perioperative period. This study does not support the effectiveness of Reiki as an adjuvant therapy to opioid therapy for postoperative pain control in pediatric patients. PMID:24439640

Double-blinded, placebo-controlled study to evaluate an antipruritic shampoo for dogs with allergic pruritus.

PubMed

Schilling, J; Mueller, R S

2012-07-28

Shampoo therapy is frequently used on pruritic dogs. However, there are few double-blinded, placebo-controlled studies of this form of therapy. This randomised, double-blinded, placebo-controlled study evaluated the efficacy of a commercial medicated shampoo (DermaTopic; Almapharm) containing chlorhexidine, lactoferrin, piroctone olamine, chitosan and essential fatty acids in 27 dogs with mild to moderate allergic pruritus without secondary skin infections. All dogs received shampoo therapy with either DermaTopic or a shampoo vehicle as placebo twice weekly for four weeks. The extent of pruritus was evaluated before the study and then on a daily basis by the owners using a visual analogue scale. Before beginning the treatment and after four weeks, the skin lesions were evaluated by an experienced clinician with a validated lesion score (Canine Atopic Dermatitis Extent and Severity Index - CADESI). The pruritus was reduced significantly by both DermaTopic and placebo. However, there was no significant difference between both groups. There was no statistically significant difference in the CADESI scores pre- and post-treatment in either group or between the two types of treatment. This study provides further evidence of the benefit of shampoo therapy for pruritic dogs.

[Computer-assisted education in problem-solving in neurology; a randomized educational study].

PubMed

Weverling, G J; Stam, J; ten Cate, T J; van Crevel, H

1996-02-24

To determine the effect of computer-based medical teaching (CBMT) as a supplementary method to teach clinical problem-solving during the clerkship in neurology. Randomized controlled blinded study. Academic Medical Centre, Amsterdam, the Netherlands. 103 Students were assigned at random to a group with access to CBMT and a control group. CBMT consisted of 20 computer-simulated patients with neurological diseases, and was permanently available during five weeks to students in the CBMT group. The ability to recognize and solve neurological problems was assessed with two free-response tests, scored by two blinded observers. The CBMT students scored significantly better on the test related to the CBMT cases (mean score 7.5 on a zero to 10 point scale; control group 6.2; p < 0.001). There was no significant difference on the control test not related to the problems practised with CBMT. CBMT can be an effective method for teaching clinical problem-solving, when used as a supplementary teaching facility during a clinical clerkship. The increased ability to solve problems learned by CBMT had no demonstrable effect on the performance with other neurological problems.

No Sensory Compensation for Olfactory Memory: Differences between Blind and Sighted People.

PubMed

Sorokowska, Agnieszka; Karwowski, Maciej

2017-01-01

Blindness can be a driving force behind a variety of changes in sensory systems. When vision is missing, other modalities and higher cognitive functions can become hyper-developed through a mechanism called sensory compensation. Overall, previous studies suggest that olfactory memory in blind people can be better than that of the sighted individuals. Better performance of blind individuals in other-sensory modalities was hypothesized to be a result of, among others, intense perceptual training. At the same time, if the superiority of blind people in olfactory abilities indeed results from training, their scores should not decrease with age to such an extent as among the sighted people. Here, this hypothesis was tested in a large sample of 94 blind individuals. Olfactory memory was assessed using the Test for Olfactory Memory, comprising episodic odor recognition (discriminating previously presented odors from new odors) and two forms of semantic memory (cued and free identification of odors). Regarding episodic olfactory memory, we observed an age-related decline in correct hits in blind participants, but an age-related increase in false alarms in sighted participants. Further, age moderated the between-group differences for correct hits, but the direction of the observed effect was contrary to our expectations. The difference between blind and sighted individuals younger than 40 years old was non-significant, but older sighted individuals outperformed their blind counterparts. In conclusion, we found no positive effect of visual impairment on olfactory memory. We suggest that daily perceptual training is not enough to increase olfactory memory function in blind people.

No Sensory Compensation for Olfactory Memory: Differences between Blind and Sighted People

PubMed Central

Sorokowska, Agnieszka; Karwowski, Maciej

2017-01-01

Blindness can be a driving force behind a variety of changes in sensory systems. When vision is missing, other modalities and higher cognitive functions can become hyper-developed through a mechanism called sensory compensation. Overall, previous studies suggest that olfactory memory in blind people can be better than that of the sighted individuals. Better performance of blind individuals in other-sensory modalities was hypothesized to be a result of, among others, intense perceptual training. At the same time, if the superiority of blind people in olfactory abilities indeed results from training, their scores should not decrease with age to such an extent as among the sighted people. Here, this hypothesis was tested in a large sample of 94 blind individuals. Olfactory memory was assessed using the Test for Olfactory Memory, comprising episodic odor recognition (discriminating previously presented odors from new odors) and two forms of semantic memory (cued and free identification of odors). Regarding episodic olfactory memory, we observed an age-related decline in correct hits in blind participants, but an age-related increase in false alarms in sighted participants. Further, age moderated the between-group differences for correct hits, but the direction of the observed effect was contrary to our expectations. The difference between blind and sighted individuals younger than 40 years old was non-significant, but older sighted individuals outperformed their blind counterparts. In conclusion, we found no positive effect of visual impairment on olfactory memory. We suggest that daily perceptual training is not enough to increase olfactory memory function in blind people. PMID:29276494

NBI‐98854, a selective monoamine transport inhibitor for the treatment of tardive dyskinesia: A randomized, double‐blind, placebo‐controlled study

PubMed Central

Jimenez, Roland; Hauser, Robert A.; Factor, Stewart A.; Burke, Joshua; Mandri, Daniel; Castro‐Gayol, Julio C.

2015-01-01

ABSTRACT Background Tardive dyskinesia is a persistent movement disorder induced by chronic neuroleptic exposure. NBI‐98854 is a novel, highly selective, vesicular monoamine transporter 2 inhibitor. We present results of a randomized, 6‐week, double‐blind, placebo‐controlled, dose‐titration study evaluating the safety, tolerability, and efficacy of NBI‐98854 for the treatment of tardive dyskinesia. Methods Male and female adult subjects with moderate or severe tardive dyskinesia were included. NBI‐98854 or placebo was given once per day starting at 25 mg and then escalated by 25 mg to a maximum of 75 mg based on dyskinesia and tolerability assessment. The primary efficacy endpoint was the change in Abnormal Involuntary Movement Scale from baseline at week 6 scored by blinded, central video raters. The secondary endpoint was the Clinical Global Impression of Change—Tardive Dyskinesia score assessed by the blinded investigator. Results Two hundred five potential subjects were screened, and 102 were randomized; 76% of NBI‐98854 subjects and 80% of placebo subjects reached the maximum allowed dose. Abnormal Involuntary Movement Scale scores for NBI‐98854 compared with placebo were significantly reduced (p = 0.0005). Active drug was also superior on the Clinical Global Impression of Change—Tardive Dyskinesia (p < 0.0001). Treatment‐emergent adverse event rates were 49% in the NBI‐98854 and 33% in the placebo subjects. The most common adverse events (active vs. placebo) were fatigue and headache (9.8% vs. 4.1%) and constipation and urinary tract infection (3.9% vs. 6.1%). No clinically relevant changes in safety assessments were noted. Conclusion NBI‐98854 significantly improved tardive dyskinesia and was well tolerated in patients. These results support the phase 3 clinical trials of NBI‐98854 now underway. © 2015 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society. PMID:26346941

NBI-98854, a selective monoamine transport inhibitor for the treatment of tardive dyskinesia: A randomized, double-blind, placebo-controlled study.

PubMed

O'Brien, Christopher F; Jimenez, Roland; Hauser, Robert A; Factor, Stewart A; Burke, Joshua; Mandri, Daniel; Castro-Gayol, Julio C

2015-10-01

Tardive dyskinesia is a persistent movement disorder induced by chronic neuroleptic exposure. NBI-98854 is a novel, highly selective, vesicular monoamine transporter 2 inhibitor. We present results of a randomized, 6-week, double-blind, placebo-controlled, dose-titration study evaluating the safety, tolerability, and efficacy of NBI-98854 for the treatment of tardive dyskinesia. Male and female adult subjects with moderate or severe tardive dyskinesia were included. NBI-98854 or placebo was given once per day starting at 25 mg and then escalated by 25 mg to a maximum of 75 mg based on dyskinesia and tolerability assessment. The primary efficacy endpoint was the change in Abnormal Involuntary Movement Scale from baseline at week 6 scored by blinded, central video raters. The secondary endpoint was the Clinical Global Impression of Change-Tardive Dyskinesia score assessed by the blinded investigator. Two hundred five potential subjects were screened, and 102 were randomized; 76% of NBI-98854 subjects and 80% of placebo subjects reached the maximum allowed dose. Abnormal Involuntary Movement Scale scores for NBI-98854 compared with placebo were significantly reduced (p = 0.0005). Active drug was also superior on the Clinical Global Impression of Change-Tardive Dyskinesia (p < 0.0001). Treatment-emergent adverse event rates were 49% in the NBI-98854 and 33% in the placebo subjects. The most common adverse events (active vs. placebo) were fatigue and headache (9.8% vs. 4.1%) and constipation and urinary tract infection (3.9% vs. 6.1%). No clinically relevant changes in safety assessments were noted. NBI-98854 significantly improved tardive dyskinesia and was well tolerated in patients. These results support the phase 3 clinical trials of NBI-98854 now underway. © 2015 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.

Double-blind, randomized, multicenter study comparing the effect of betahistine and flunarizine on the dizziness handicap in patients with recurrent vestibular vertigo.

PubMed

Albera, Roberto; Ciuffolotti, Roberto; Di Cicco, Maurizio; De Benedittis, Giuseppe; Grazioli, Irene; Melzi, Gabriella; Mira, Eugenio; Pallestrini, Eugenio; Passali, Desiderio; Serra, Agostino; Vicini, Claudio

2003-06-01

The aim of this double-blind, randomized, multicenter study was to compare the efficacy of betahistine dihydrochloride (BH) and flunarizine (FL) using the Dizziness Handicap Inventory (DHI), a validated self-assessment questionnaire that has not previously been used in a clinical trial to evaluate antivertigo drugs. Patients with recurrent vertigo of peripheral vestibular origin and who were severely handicapped by vertigo were randomized to an 8-week course of treatment with oral BH 48 mg daily or oral FL 10 mg daily. The efficacy endpoints were the total DHI score and the physical, functional and emotional subscores. Fifty-two patients completed the study. After 8 weeks of treatment the mean total DHI score and the physical subscore were significantly lower in the BH group compared to the FL group (7.5 and 3.6 points, respectively). The mean total DHI score as well as the three subscores decreased significantly after 4 and 8 weeks in both treatment groups. This study showed that at 8 weeks BH is significantly more effective than FL in terms of improving the total DHI score and the physical subscore. It was also established that the DHI is a useful and reliable method for evaluating the efficacy of antivertigo drugs.

Management options of chronic low back pain. A randomized blinded clinical trial.

PubMed

Nazzal, Mahmoud E; Saadah, Mohammed A; Saadah, Loai M; Al-Omari, Mahmoud A; Al-Oudat, Ziad A; Nazzal, Mohammed S; El-Beshari, Mahfoud Y; Al-Zaabi, Amani A; Alnuaimi, Yousif I

2013-04-01

To compare efficacies of 2 active programs in the management of chronic low back pain (CLBP). This prospective, stratified, randomized single-blinded controlled study was conducted in the Department of Rehabilitation Medicine, King Abdullah University Hospital, Irbid, Jordan, between February and December 2010. A total of 100 patients were randomized to either 6-weeks of multidisciplinary rehabilitation (group A) or therapist-assisted exercise (group B). At baseline and 6 weeks, the visual analogue scale (VAS) pain score was estimated, as a primary outcome measure. McGill pain score, Oswestry Disability Index (ODI), trunk forward flexion and extension, left and right lateral bending, were applied before and after treatment and were employed as secondary outcome measures. All outcome measures significantly improved in group A after treatment, compared with group B. The VAS, McGill, ODI scores, left and right lateral bending decreased significantly, whereas forward and backward bending increased. A significant number of patients returned to work in group A at the end of 6 weeks, compared with group B. These effects were maintained over 12 and 24 weeks of follow-up. Multidisciplinary rehabilitation improved functional indices and pain scale scores in group A compared with B. This would be an effective strategy in CLBP management.

Do cannabis-based medicinal extracts have general or specific effects on symptoms in multiple sclerosis? A double-blind, randomized, placebo-controlled study on 160 patients.

PubMed

Wade, Derick T; Makela, Petra; Robson, Philip; House, Heather; Bateman, Cynthia

2004-08-01

The objective was to determine whether a cannabis-based medicinal extract (CBME) benefits a range of symptoms due to multiple sclerosis (MS). A parallel group, double-blind, randomized, placebo-controlled study was undertaken in three centres, recruiting 160 outpatients with MS experiencing significant problems from at least one of the following: spasticity, spasms, bladder problems, tremor or pain. The interventions were oromucosal sprays of matched placebo, or whole plant CBME containing equal amounts of delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) at a dose of 2.5-120 mg of each daily, in divided doses. The primary outcome measure was a Visual Analogue Scale (VAS) score for each patient's most troublesome symptom. Additional measures included VAS scores of other symptoms, and measures of disability, cognition, mood, sleep and fatigue. Following CBME the primary symptom score reduced from mean (SE) 74.36 (11.1) to 48.89 (22.0) following CBME and from 74.31 (12.5) to 54.79 (26.3) following placebo [ns]. Spasticity VAS scores were significantly reduced by CBME (Sativex) in comparison with placebo (P =0.001). There were no significant adverse effects on cognition or mood and intoxication was generally mild.

Effects of Aloe Sterol Supplementation on Skin Elasticity, Hydration, and Collagen Score: A 12-Week Double-Blind, Randomized, Controlled Trial.

PubMed

Tanaka, Miyuki; Yamamoto, Yuki; Misawa, Eriko; Nabeshima, Kazumi; Saito, Marie; Yamauchi, Koji; Abe, Fumiaki; Furukawa, Fukumi

2016-01-01

Our previous study confirmed that Aloe sterol stimulates collagen and hyaluronic acid production in human dermal fibroblasts. This study aims to investigate whether Aloe sterol intake affects skin conditions. We performed a 12-week, randomized, double-blind, placebo-controlled study to evaluate the effects of oral Aloe sterol supplementation on skin elasticity, hydration, and the collagen score in 64 healthy women (age range 30-59 years; average 44.3 years) who were randomly assigned to receive either a placebo or an Aloe sterol-supplemented yogurt. Skin parameters were measured and ultrasound analysis of the forearm was performed. ANCOVA revealed statistical differences in skin moisture, transepidermal water loss, skin elasticity, and collagen score between the Aloe sterol and placebo groups. The gross elasticity (R2), net elasticity (R5), and biological elasticity (R7) scores of the Aloe sterol group significantly increased with time. In addition, skin fatigue area F3, which is known to decrease with age and fatigue, also increased with Aloe sterol intake. Ultrasound echogenicity revealed that the collagen content in the dermis increased with Aloe sterol intake. The results suggest that continued Aloe sterol ingestion contributes to maintaining healthy skin. © 2017 S. Karger AG, Basel.

Use of honey associated with Ananas comosus (Bromelin) in the treatment of acute irritative cough

PubMed Central

Peixoto, Décio Medeiros; Rizzo, José Angelo; Schor, Deborah; Silva, Almerinda Rêgo; de Oliveira, Dinaldo Cavalcanti; Solé, Dirceu; Sarinho, Emanuel

2016-01-01

Abstract Objective: To evaluate the immediate improvement rate of irritative cough in patients treated with the combination of Ananas comosus extract and honey (Bromelin®) compared with the use of honey alone (placebo group). Methods: Pragmatic, double-blind, randomized, parallel-group study with children aged between 2 and 15 years, with irritative cough for at least 24hours. The double-blind assessment of cough was through the number of observed coughing episodes and intensity score for a period of 10minutes of observation. The decrease of one point in the mean total score was considered as a therapeutic effect. Results: There was a reduction in coughing episodes in both groups, as well as in the cough score after 30minutes of drug or honey administration. The change in clinical score above two points, which could indicate marked improvement, occurred in five patients in the bromelin group and only in one in the placebo group, but without significant difference. There were no adverse events. Conclusions: The immediate improvement rate of irritative cough was similar in patients treated with combination of Ananas comosus extract and honey (Bromelin®) compared with the use of honey alone (placebo group). It is possible that honey has a therapeutic effect on mucus and cough characteristics (Clinical Trials: NCT01356693). PMID:27181342

Vision impairment and major causes of vision loss impacts on vision-specific functioning independent of socioeconomic factors.

PubMed

Chiang, Peggy P C; Zheng, Yingfeng; Wong, Tien Y; Lamoureux, Ecosse L

2013-02-01

To quantify the eye disease-specific impact of unilateral and bilateral vision impairment (VI) on vision-specific functioning (VF). The Singapore Indian Eye population-based study. Ethnic Indians older than 40 years of age living in Singapore. Participants underwent standardized ophthalmic assessments for VI and blindness, defined using presenting visual acuity (United States definition). Sociodemographic data were recorded using a standardized questionnaire. Rasch analysis was used to validate the Visual Function Index 11 and to determine its psychometric properties. The major causes of VI (i.e., cataract, refractive error, age-related macular degeneration, diabetic retinopathy [DR], and glaucoma) were determined by ophthalmologists on examination. Multivariate linear regression analysis was performed to assess the impact of VI on the overall VF Rasch score. Vision-specific functioning. Three thousand three hundred ninety-six persons were analyzed. Participants with VI had a systematic reduction in VF score compared with those with normal vision in both eyes, ranging from -11.2% normal vision in one eye and low vision in the other eye (95% confidence interval [CI], -12.2% to -10.3%; P<0.001), to -12.7% blindness in one eye and normal vision in the other eye (CI, -15.1% to -10.4%; P<0.001), to -19.4% low vision in both eyes (CI, -20.8% to -18.1%; P<0.001), to -52.9% blindness in one eye and low vision in other eye (CI, -55.3% to -50.4%; P<0.001), to -77.2% blindness in both eyes (CI, -82.4% to 72.0%; P<0.001). The impact of VI on VF score varied across different major causes of vision loss, regardless of socioeconomic factors. Vision impairment attributed to cataract in one or both eyes had a significant decrease in VF score by 17.7% and 22.3%, respectively, compared with those with normal vision in both eyes (P<0.001). The impact of unilateral and bilateral VI on VF score was greater in participants with glaucoma (32.2% in unilateral cases and 35.9% in bilateral cases; P<0.001) and DR (29.4% in unilateral cases and 33.3% in bilateral cases; P<0.001). Vision impairment and major age-related eye diseases such as cataract, DR, and glaucoma are associated significantly with worse deterioration in VF, regardless of education level, literacy adequacy, or immigration pattern. Glaucoma and DR seemed to have a greater negative impact on VF score compared with cataract. This study highlights the importance of disease-specific interventions in reducing the adverse impact of VI on daily activities. Copyright © 2013 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Efficacy of Glutamate Modulators in Tic Suppression: A Double-Blind, Randomized Control Trial of D-serine and Riluzole in Tourette Syndrome.

PubMed

Lemmon, Monica E; Grados, Marco; Kline, Tina; Thompson, Carol B; Ali, Syed F; Singer, Harvey S

2015-06-01

It has been hypothesized that glutamatergic transmission may be altered in Tourette syndrome. In this study, we explored the efficacy of a glutamate agonist (D-serine) and antagonist (riluzole) as tic-suppressing agents in children with Tourette syndrome. We performed a parallel three-arm, 8-week, double-blind, randomized placebo-controlled treatment study in children with Tourette syndrome. Each child received 6 weeks of treatment with D-serine (maximum dose 30 mg/kg/day), riluzole (maximum dose 200 mg/day), or placebo, followed by a 2-week taper. The primary outcome measure was effective tic suppression as determined by the differences in the Yale Global Tic Severity Scale score; specifically, the total tic score and the combined score (total tic score + global impairment) between treatment arms after 6 weeks of treatment. Mann-Whitney U tests were performed to analyze differences between each group and the placebo group. Twenty-four patients (males = 21, ages 9-18) enrolled in the study; one patient dropped out before completion. Combined Yale Global Tic Severity Scale score and total tic scores improved in all groups. The 6-week mean percent improvement of the riluzole (n = 10), D-serine (n = 9), and placebo (n = 5) groups in the combined Yale Global Tic Severity Scale score were 43.7, 39.5, and 30.2 and for total tic scores were 38.0, 25.0, and 34.0, respectively. There were no significant differences in Yale Global Tic Severity Scale score or total tic score, respectively, between the riluzole and placebo (P = 0.35, 0.85) or D-serine and placebo (P = 0.50, 0.69) groups. Tics diminished by comparable percentages in the riluzole, D-serine, and placebo groups. These preliminary data suggest that D-serine and riluzole are not effective in tic suppression. Copyright © 2015 Elsevier Inc. All rights reserved.

Intra-articular Autologous Conditioned Plasma Injections Provide Safe and Efficacious Treatment for Knee Osteoarthritis: An FDA-Sanctioned, Randomized, Double-blind, Placebo-controlled Clinical Trial.

PubMed

Smith, Patrick A

2016-04-01

Platelet-rich plasma (PRP) injections have become an intriguing treatment option for osteoarthritis (OA), particularly OA of the knee. Despite the plethora of PRP-related citations, there is a paucity of high-level evidence that is comparable, cohort specific, dose controlled, injection protocol controlled, and double-blinded. To determine the safety and efficacy of leukocyte-poor PRP autologous conditioned plasma (ACP) for knee OA treatment through a feasibility trial regulated by the US Food and Drug Administration (FDA). Randomized controlled trial; Level of evidence, 1. In accordance with FDA protocol, patient selection was based on strict inclusion/exclusion criteria; 114 patients were screened, and 30 were ultimately included in the study. These patients were randomized to receive either ACP (n = 15) or saline placebo (n = 15) for a series of 3 weekly injections. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores served as the primary efficacy outcome measure. Patients were followed for 1 year. No adverse events were reported for ACP administration. Furthermore, the results demonstrated no statistically significant difference in baseline WOMAC scores between the 2 groups. However, in the ACP group, WOMAC scores at 1 week were significantly decreased compared with baseline scores, and the scores for this group remained significantly lower throughout the study duration. At the study conclusion (12 months), subjects in the ACP group had improved their overall WOMAC scores by 78% from their baseline score, compared with 7% for the placebo group. ACP is safe and provides quantifiable benefits for pain relief and functional improvement with regard to knee OA. No adverse events were reported for ACP administration. After 1 year, WOMAC scores for the ACP subjects had improved by 78% from their baseline score, whereas scores for the placebo control group had improved by only 7%. Other joints affected with OA may also benefit from this treatment. © 2016 The Author(s).

Ethnicity and Deprivation are Associated With Blindness Among Adults With Primary Glaucoma in Nigeria: Results From the Nigeria National Blindness and Visual Impairment Survey.

PubMed

Kyari, Fatima; Wormald, Richard; Murthy, Gudlavalleti V S; Evans, Jennifer R; Gilbert, Clare E

2016-10-01

We explored the risk factors for glaucoma blindness among adults aged 40 years and above with primary glaucoma in Nigeria. A total of 13,591 participants aged 40 years and above were examined in the Nigeria Blindness Survey; 682 (5.02%; 95 CI, 4.60%-5.47%) had glaucoma by ISGEO's criteria. This was a case-control study (n=890 eyes of 629 persons): glaucoma blind persons were cases and glaucoma not-blind were controls. Education and occupation were used to determine socioeconomic status scores, which were divided into 3 tertiles (affluent, medium, deprived). We assessed sociodemographic, biophysical, and ocular factors by logistic regression analysis for association with glaucoma blindness. Multinomial regression analysis was also performed with nonglaucoma as the reference category. A total of 119/629 (18.9%; 95% CI, 15.9%-22.4%) persons were blind in both eyes; 510 were controls. There was interethnic variation in odds of blindness; age, male sex, socioeconomic status, prior diagnosis of glaucoma, hypertension, intraocular pressure, and lens opacity were associated with glaucoma blindness. Axial length, mean ocular perfusion pressure, and angle-closure glaucoma were associated with blind glaucoma eyes. In multivariate analysis, Igbo ethnicity (OR=2.79; 95% CI, 1.03-7.57) had higher risk as was being male (OR=4.59; 95% CI, 1.73-12.16) and unmarried (OR=2.50; 95% CI, 1.03-6.07). Deprivation (OR=3.57; 95% CI, 1.46-8.72), prior glaucoma diagnosis (OR=5.89; 95% CI, 1.79-19.40), and intraocular pressure (OR=1.07; 95% CI, 1.04-1.09) were also independent risk factors for glaucoma blindness. Approximately 1 in 5 people with primary glaucoma were blind. Male sex, ethnicity and deprivation were strongly associated with blindness. Services for glaucoma need to improve in Nigeria, focusing on poor communities and men.

Alpha1 LASSO data bundles Lamont, OK

DOE Data Explorer

Gustafson, William Jr; Vogelmann, Andrew; Endo, Satoshi; Toto, Tami; Xiao, Heng; Li, Zhijin; Cheng, Xiaoping; Krishna, Bhargavi (ORCID:000000018828528X)

2016-08-03

A data bundle is a unified package consisting of LASSO LES input and output, observations, evaluation diagnostics, and model skill scores. LES input includes model configuration information and forcing data. LES output includes profile statistics and full domain fields of cloud and environmental variables. Model evaluation data consists of LES output and ARM observations co-registered on the same grid and sampling frequency. Model performance is quantified by skill scores and diagnostics in terms of cloud and environmental variables.

Recovery from sevoflurane anesthesia in horses: comparison to isoflurane and effect of postmedication with xylazine.

PubMed

Matthews, N S; Hartsfield, S M; Mercer, D; Beleau, M H; MacKenthun, A

1998-01-01

To compare recovery from sevoflurane or isoflurane anesthesia in horses. Prospective, randomized cross-over design. Nine Arabian horses (3 mares, 3 geldings, and 3 stallions) weighing 318 to 409 kg, 4 to 20 years old. Horses were anesthetized on three occasions with xylazine (1.1 mg/kg), Diazepam (0.03 mg/kg intravenously [i.v.]), and ketamine (2.2 mg/kg i.v.). After intubation, they were maintained with isoflurane or sevoflurane for 90 minutes. On a third occasion, horses were maintained with sevoflurane and given xylazine (0.1 mg/kg i.v.) when the vaporizer was turned off. Horses were not assisted in recovery and all recoveries were videotaped. Time to extubation, first movement, sternal, and standing were recorded as was the number of attempts required to stand. Recoveries were scored on a 1 to 6 scoring system (1 = best, 6 = worst) by the investigators, and by three evaluators who were blinded to the treatments the horses received. These blinded evaluators assessed the degree of ataxia present at 10 minutes after each horse stood, and recorded the time at which they judged the horse to be ready to leave the recovery stall. Mean times (+/- SD) to extubation, first movement, sternal, and standing were 4.1 (1.7), 6.7 (1.9), 12.6 (4.6), and 17.4 (7.2) minutes with isoflurane; 3.4 (0.8), 6.6 (3.1), 10.3 (3.1), and 13.9 (3.0) minutes with sevoflurane; and 4.0 (1.2), 9.1 (3.3), 13.8 (6.5), and 18.0 (7.1) with sevoflurane followed by xylazine. Horses required a mean number of 4 (2.3), 2 (0.9), and 2 ( 1.6) attempts to stand with isoflurane, sevoflurane, and sevoflurane followed by xylazine respectively. The mean recovery score (SD) for isoflurane was 2.9 (1.2) from investigators and 2.4 (1.1) from blinded evaluators. For sevoflurane, the mean recovery score was 1.7 (0.9) from investigators and 1.9 (1.1) from evaluators, whereas the recoveries from sevoflurane with xylazine treatment were scored as 1.7 (1.2) from investigators and 1.7 (1.0) from blinded evaluators. Recoveries appeared to vary widely from horse to horse, but were significantly shorter with sevoflurane than isoflurane, although sevoflurane followed by xylazine was no different from isoflurane. Under the conditions of the study, recoveries from sevoflurane and sevoflurane followed by xylazine were of better quality than those from isoflurane. Sevoflurane anesthesia in horses may contribute to a shorter, safer recovery from anesthesia.

GPU-based parallel algorithm for blind image restoration using midfrequency-based methods

NASA Astrophysics Data System (ADS)

Xie, Lang; Luo, Yi-han; Bao, Qi-liang

2013-08-01

GPU-based general-purpose computing is a new branch of modern parallel computing, so the study of parallel algorithms specially designed for GPU hardware architecture is of great significance. In order to solve the problem of high computational complexity and poor real-time performance in blind image restoration, the midfrequency-based algorithm for blind image restoration was analyzed and improved in this paper. Furthermore, a midfrequency-based filtering method is also used to restore the image hardly with any recursion or iteration. Combining the algorithm with data intensiveness, data parallel computing and GPU execution model of single instruction and multiple threads, a new parallel midfrequency-based algorithm for blind image restoration is proposed in this paper, which is suitable for stream computing of GPU. In this algorithm, the GPU is utilized to accelerate the estimation of class-G point spread functions and midfrequency-based filtering. Aiming at better management of the GPU threads, the threads in a grid are scheduled according to the decomposition of the filtering data in frequency domain after the optimization of data access and the communication between the host and the device. The kernel parallelism structure is determined by the decomposition of the filtering data to ensure the transmission rate to get around the memory bandwidth limitation. The results show that, with the new algorithm, the operational speed is significantly increased and the real-time performance of image restoration is effectively improved, especially for high-resolution images.

Comparing the effectiveness of ultrasound-guided versus blind steroid injection in the treatment of severe carpal tunnel syndrome

PubMed

Karaahmet, Özgür Zeliha; Gürçay, Eda; Kara, Murat; Serçe, Azize; Kıraç Ünal, Zeynep; Çakcı, Aytül

2017-12-19

Background/aim: This study aimed to compare the effectiveness of ultrasound (US)-guided injection versus blind injection of corticosteroids in the treatment of carpal tunnel syndrome (CTS). Materials and methods: This prospective, randomized clinical trial included patients with severe CTS based on clinical and electrophysiological criteria. The patients were evaluated for clinical and electrophysiological parameters at baseline and 4 weeks after treatment. Symptom severity and hand function were assessed by the Boston questionnaire. The patients underwent blind injection or US-guided injection. Results: When compared with baseline, both groups showed significant improvement in Boston questionnaire scores and all electrophysiological parameters. Significant differences were observed between the groups for clinical parameters (Boston Symptom Severity Scale: P = 0.007; Functional Status Scale: P < 0.001) in favor of the US-guided group. Conclusion: This study demonstrated that both US-guided and blind injections were effective in reducing symptoms and improving hand function. US-guided injections may yield more effective clinical results in the short-term than blind injections in the treatment of patients with severe CTS.

36 CFR 701.6 - Loans of library materials for blind and other physically handicapped persons.

Code of Federal Regulations, 2011 CFR

2011-07-01

... or private schools where handicapped students are enrolled; however, the students in public or... their educational, vocational, and cultural opportunities in the field of music. Such scores, texts, and...

[Crataegus Special Extract WS 1442 in NYHA II heart failure. A placebo controlled randomized double-blind study].

PubMed

Leuchtgens, H

1993-07-20

In 30 patients with stage NYHA II cardiac insufficiency, a placebo-controlled randomized double-blind study was carried out to determine the efficacy of the Crataegus special extract WS 1442. Treatment duration was 8 weeks, and the substance was administered at a dose of 1 capsule taken twice a day. The main target parameters were alteration in the pressure-x-rate product (PRP) under standardised loading on a bicycle ergometer, and a score of subjective improvement of complaints elicited by a questionnaire. Secondary parameters were exercise tolerance and the change in heart rate and arterial blood pressure. The active substance group showed a statistically significant advantage over placebo in terms of changes in PRP (at a load of 50 W) and the score, but also in the secondary parameter heart rate. In both groups, systolic and diastolic blood pressure was mildly reduced. No adverse reactions occurred.

Chinese herbal Pulian ointment in treating psoriasis vulgaris of blood-heat syndrome: a multi-center, double-blind, randomized, placebo-controlled trial.

PubMed

Li, Nuo; Zhao, Wenbin; Xing, Jianmin; Liu, Jianping; Zhang, Guangzhong; Zhang, Yunbi; Li, Yuanwen; Liu, Wali; Shi, Fei; Bai, Yanping

2017-05-15

Traditional Chinese medicine (TCM) has a long history in the treatment of psoriasis vulgaris. We aimed to evaluate the clinical efficacy and safety of Chinese herbal Pulian ointment in treating psoriasis vulgaris of blood-heat syndrome. A multicenter, randomized, double-blind, placebo-controlled trial was conducted. Participants with psoriasis vulgaris of blood-heat syndrome were blinded and randomized to receive Pulian ointment or placebo ointment twice daily for 4 weeks, with follow-up 8 weeks after treatment. Psoriasis Area Severity Index (PASI) scores, severity of each symptom and area of skin lesion and quality of life were assessed at baseline, 2 weeks, and 4 weeks. Adverse events were recorded during the study. SAS 9.4 software and SPSS 17.0 software was applied for data analysis. A total of 300 participants with psoriasis vulgaris of blood-heat syndrome were assessed for eligibility, and 294 were randomly assigned to the Pulian ointment and placebo group from six study centers. Full analysis set (FAS): after 4 weeks of treatment, there were significant differences between groups in PASI score and the separate score of skin lesion area, favoring Pulian ointment group (P < 0.05). However, no significant differences were observed in scores of scaling, erythema and induration/thickness (P > 0.05). Per protocol set (PPS): There was no statistically significant difference in PASI score and separate score of each symptom and area of skin lesion between two groups (P > 0.05). Quality of life measured by Hamilton Anxiety Rating Scale (HAMA) and 36-Item Short Form Health Survey (SF-36) improved after treatment in both groups, but there was no significant difference between the two groups (P > 0.05). After being followed up for 8 weeks, the total relapse rates of the Pulian Ointment group and placebo group were 5.88 and 8.45%, respectively, and the difference was not statistically significant between the two groups (P > 0.05). No adverse event was observed in both groups throughout the study. Pulian Ointment seems effective and well tolerated in improving the PASI score and separate score of skin lesion area for patients with psoriasis vulgaris of blood-heat syndrome. Further research could build on the current study to explore whether other preparation forms and greater intervention intensity are necessary for better therapeutic effects. Chictr.org.cn Identifier ChiCTR-TRC-12002054 .

Effect of Linear Low-Intensity Extracorporeal Shockwave Therapy for Erectile Dysfunction-12-Month Follow-Up of a Randomized, Double-Blinded, Sham-Controlled Study.

PubMed

Fojecki, Grzegorz Lukasz; Tiessen, Stefan; Osther, Palle Jørn Sloth

2018-03-01

Short-term data on the effect of low-intensity extracorporeal shockwave therapy (Li-ESWT) on erectile dysfunction (ED) have been inconsistent. The suggested mechanisms of action of Li-ESWT on ED include stimulation of cell proliferation, tissue regeneration, and angiogenesis, which can be processes with a long generation time. Therefore, long-term data on the effect of Li-ESWT on ED are strongly warranted. To assess the outcome at 6 and 12 months of linear Li-ESWT on ED from a previously published randomized, double-blinded, sham-controlled trial. Subjects with ED (N = 126) who scored lower than 25 points in the erectile function domain of the International Index of Erectile Function (IIEF-EF) were eligible for the study. They were allocated to 1 of 2 groups: 5 weekly sessions of sham treatment (group A) or linear Li-ESWT (group B). After a 4-week break, the 2 groups received active treatment once a week for 5 weeks. At baseline and 6 and 12 months, subjects were evaluated by the IIEF-EF, the Erectile Hardness Scale (EHS), and the Sexual Quality of Life in Men. The primary outcome measure was an increase of at least 5 points in the IIEF-EF (ΔIIEF-EF score). The secondary outcome measure was an increase in the EHS score to at least 3 in men with a score no higher than 2 at baseline. Data were analyzed by linear and logistic regressions. Linear regression of the ΔIIEF-EF score from baseline to 12 months included 95 patients (dropout rate = 25%). Adjusted for the IIEF-EF score at baseline, the difference between groups B and A was -1.30 (95% CI = -4.37 to 1.77, P = .4). The success rate based on the main outcome parameter (ΔIIEF-EF score ≥ 5) was 54% in group A vs 47% in group B (odds ratio = 0.67, P = .28). Improvement based on changes in the EHS score in groups A and B was 34% and 24%, respectively (odds ratio = 0.47, P = .82). Exposure to 2 cycles of linear Li-ESWT for ED is not superior to 1 cycle at 6- and 12-month follow-ups. Fojecki GL, Tiessen S, Osther PJS. Effect of Linear Low-Intensity Extracorporeal Shockwave Therapy for Erectile Dysfunction-12-Month Follow-Up of a Randomized, Double-Blinded, Sham-Controlled Study. Sex Med 2018;6:1-7. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Treatment of Common Cold Patients with the Shi-Cha Capsule: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Dose-Escalation Trial

PubMed Central

Chang, Jing; Dong, Shou-Jin; She, Bin; Zhang, Rui-Ming; Meng, Mao-Bin; Xu, Yan-Ling; Wan, Li-Ling; Shi, Ke-Hua; Pan, Jun-Hun; Mao, Bing

2012-01-01

This study was designed to determine the therapeutic efficacy and safety of the Shi-cha capsule, a Chinese herbal formula, in the treatment of patients with wind-cold type common cold. In our multi-center, prospective, double-blind, randomized, placebo-controlled, dose-escalation trial, patients with wind-cold type common cold received 0.6 g of Shi-cha capsule plus 0.6 g placebo (group A), 1.2 g of Shi-cha capsule (group B), or 1.2 g placebo (group C), three times daily for 3 days and followed up to 10 days. The primary end point was all symptom duration. The secondary end points were main symptom duration, minor symptom duration, the changes in cumulative symptom score, main symptom score, and minor symptom score 4 days after the treatment, as well as adverse events. A total of 377 patients were recruited and 360 met the inclusive criteria; 120 patients constituted each treatment group. Compared with patients in group C, patients in groups A and B had significant improvement in the all symptom duration, main symptom duration, minor symptom duration, as well as change from baseline of cumulative symptom score, main symptom score, and minor symptom score at day 4. The symptom durations and scores showed slight superiority of group B over group A, although these differences were not statistically significant. There were no differences in adverse events. The Shi-cha capsule is efficacious and safe for the treatment of patients with wind-cold type common cold. Larger trials are required to fully assess the benefits and safety of this treatment for common cold. PMID:23346193

Meniscus Induced Cartilaginous Damage and Non-linear Gross Anatomical Progression of Early-stage Osteoarthritis in a Canine Model

PubMed Central

Kahn, David; Mittelstaedt, Daniel; Matyas, John; Qu, Xiangui; Lee, Ji Hyun; Badar, Farid; Les, Clifford; Zhuang, Zhiguo; Xia, Yang

2016-01-01

Background: The predictable outcome of the anterior cruciate ligament transection (ACLT) canine model, and the similarity to naturally occurring osteoarthritis (OA) in humans, provide a translatable method for studying OA. Still, evidence of direct meniscus-induced cartilaginous damage has not been identified, and gross-anatomical blinded scoring of early-stage OA has not been performed. Objective: A gross anatomical observation and statistical analysis of OA progression to determine meniscus induced cartilaginous damage, to measure the macroscopic progression of OA, and to address matters involving arthroscopic and surgical procedures of the knee. Method: Unblinded assessment and blinded scoring of meniscal, tibial, femoral, and patellar damage were performed for control and at four time points following unilateral ACLT: 3-week (N=4), 8-week (N=4), 12-week (N=5), and 25-week (N=4). Mixed-model statistics illustrates damage (score) progression; Wilcoxon rank-sum tests compared time-point scores; and Wilcoxon signed-rank tests compared ACLT and contralateral scores, and meniscus and tibia scores. Result: Damage was manifest first on the posterior aspect of the medial meniscus and subsequently on the tibia and femur, implying meniscal damage can precede, coincide with, and aggravate cartilage damage. Damage extent varied chronologically and was dependent upon the joint component. Meniscal damage was evident at 3 weeks and progressed through 25-weeks. Meniscal loose bodies corresponded to tibial cartilage damage location and extent through 12 weeks, followed by cartilage repair activity after complete meniscal degeneration. Conclusion: This study provides additional information for understanding OA progression, identifying OA biomarkers, and arthroscopic and meniscectomy procedures. PMID:28144379

Effect of Transcranial Direct Current Stimulation on Neurorehabilitation of Task-Specific Dystonia: A Double-Blind, Randomized Clinical Trial.

PubMed

Rosset-Llobet, Jaume; Fàbregas-Molas, Sílvia; Pascual-Leone, Álvaro

2015-09-01

Task-specific focal hand dystonia can disable affected individuals. Although neurorehabilitation techniques such as sensory motor retuning can result in complete recovery in some patients, it requires many months of treatment. Combining transcranial direct current stimulation (tDCS) with neurorehabilitation is a new and promising approach that can help these patients. However, the results in different studies are contradictory. Analyze whether delivering tDCS (cathode over left and anode over right parietal region) during the neurorehabilitation process for musicians with dystonia can increase the effectiveness of therapy. A parallel double-blind randomized design was used to study 30 musicians with right-hand primary focal dystonia. All patients underwent a 2-week course of neurorehabilitation based on sensory motor retuning therapy coupled with either real or sham tDCS for the first 30 minutes of each daily 1-hour therapy session (total 10 sessions). The therapist and patient were blind to the tDCS condition. A dystonia severity score was obtained before and after the 2-week protocol. The therapist also rated the evolution of each patient. Both groups significantly improved their dystonia severity score during the 2 weeks. Score differences were 88.23 (±40.51) and 63.36 (±30.57) for the active and sham groups, respectively. The active group showed a statistically significant greater improvement. Biparietal tDCS with left-sided cathode is a safe technique that does not interfere with the neurorehabilitation procedure and can increase therapy effectiveness in rehabilitation patients with right-hand task-specific focal dystonia.

Norm-Referenced Tests and Race-Blind Admissions: The Case for Eliminating the SAT and ACT at the University of California. Research & Occasional Paper Series: CSHE.15.17

ERIC Educational Resources Information Center

Geiser, Saul

2017-01-01

Of all college admission criteria, scores on nationally normed tests like the SAT and ACT are most affected by the socioeconomic background of the student. The effect of socioeconomic background on test scores has grown substantially at University of California over the past two decades, and tests have become more of a barrier to admission of…

Oral scopolamine augmentation in moderate to severe major depressive disorder: a randomized, double-blind, placebo-controlled study.

PubMed

Khajavi, Danial; Farokhnia, Mehdi; Modabbernia, Amirhossein; Ashrafi, Mandana; Abbasi, Seyed-Hesammedin; Tabrizi, Mina; Akhondzadeh, Shahin

2012-11-01

To evaluate the antidepressant effect of oral scopolamine as an adjunct to citalopram. In this randomized double-blind placebo-controlled study, patients were assessed in the outpatient clinics of 2 large hospitals from November 2011 to January 2012. Forty patients (18-55 years) with major depressive disorder (DSM-IV-TR criteria) and 17-Item Hamilton Depression Rating Scale (HDRS) score ≥ 22 were randomly assigned to scopolamine hydrobromide (1 mg/d) (n = 20) or placebo (n = 20) in addition to citalopram for 6 weeks. HDRS score was measured at baseline and days 4, 7, 14, 28, and 42. The primary outcome measure was HDRS score change from baseline to week 6 in the scopolamine group versus the placebo group. Response was defined as ≥ 50% decrease in HDRS score; remission, as HDRS score ≤ 7. Augmentation with scopolamine was significantly more effective than placebo (F(1,38) = 5.831, P = .021). Patients receiving scopolamine showed higher rates of response (65%, 13/20 at week 4) and remission (65%, 13/20 at week 6) than the placebo group (30%, 6/20 and 20%, 4/20, respectively; P = .027, P = .004, respectively). Patients in the scopolamine group showed higher rates of dry mouth, blurred vision, and dizziness than the placebo group. Oral scopolamine is a safe and effective adjunct for treatment of patients with moderate to severe major depressive disorder. Iranian Registry of Clinical Trials identifier: IRCT201201181556N31. © Copyright 2012 Physicians Postgraduate Press, Inc.

Pimecrolimus cream 1% in the treatment of intertriginous psoriasis: a double-blind, randomized study.

PubMed

Gribetz, Carin; Ling, Mark; Lebwohl, Mark; Pariser, David; Draelos, Zoe; Gottlieb, Alice B; Zaias, Nardo; Chen, Diana M; Parneix-Spake, Anne; Hultsch, Thomas; Menter, Alan

2004-11-01

Inverse psoriasis can be difficult to treat because of the high sensitivity of intertriginous areas to cutaneous side effects, such as irritation and striae. Pimecrolimus, a well-tolerated, nonatrophogenic, skin-selective inflammatory cytokine inhibitor, has been shown to be effective in the treatment of psoriasis when applied topically under occlusion. This study evaluated the efficacy and safety of pimecrolimus cream 1% versus vehicle twice a day in the treatment of inverse psoriasis. Methods This was a double-blind, randomized, vehicle-controlled study in 57 patients with moderate to severe inverse psoriasis. Patients were evaluated using Investigator's Global Assessment of overall severity, Target Area Score, and Patient Self-Assessment. A significant between-group difference was observed early on, with 54% of the pimecrolimus group versus 21% of the vehicle group having an Investigator's Global Assessment score of 0 or 1 (clear or almost clear) at week 2 ( P = .0169). By week 8, 71% of the pimecrolimus group had an Investigator's Global Assessment score of 0 or 1. Change from baseline in Target Area Score was -2.4 (pimecrolimus group) compared with -0.7 (vehicle) at day 3 ( P < .0001). By week 8, 82% of patients using pimecrolimus scored their disease as well or completely controlled versus 41% of the vehicle group ( P = .0007). Adverse events were similar between groups. Pimecrolimus cream 1% is an effective treatment for inverse psoriasis with a rapid onset of action, and is safe and well-tolerated.

Determination of the effect of brand and product identification on consumer palatability ratings of ground beef patties.

PubMed

Wilfong, A K; McKillip, K V; Gonzalez, J M; Houser, T A; Unruh, J A; Boyle, E A E; O'Quinn, T G

2016-11-01

The objective of this study was to determine the effect of brand and product identification on consumer palatability ratings of ground beef patties. Six treatments were used in the study: 90/10 Certified Angus Beef (CAB) ground sirloin, 90/10 ground beef, 80/20 CAB ground chuck, 80/20 ground chuck, 80/20 ground beef, and 73/27 CAB ground beef. Ground beef was processed into 151.2-g patties using a patty former with 2 consecutively formed patties assigned to blind consumer testing and the following 2 assigned to informed testing. Following cooking to 74°C, patties were cut into quarters and served to consumers. Consumers ( = 112) evaluated samples in 2 rounds for tenderness, juiciness, flavor liking, texture liking, and overall liking. Each trait was also rated as either acceptable or unacceptable. In the first round of testing, samples were blind evaluated, with no information about the treatments provided to consumers, but in the second round, product type and brand were disclosed prior to sample evaluation. Additionally, texture profile and shear force analyses were performed on patties from each treatment. Few differences were observed for palatability traits during blind consumer testing; however, during informed testing, 90/10 CAB ground sirloin was rated greatest ( < 0.05) for all palatability traits other than juiciness. Also, 90/10 CAB ground sirloin had increased ( < 0.05; (consumer informed score - consumer blind score)/consumer blind score) ratings for tenderness (17.4%), juiciness (36.5%), flavor liking (23.3%), texture liking (18.2%), and overall liking (24.7%) due to brand disclosure. Increased ( < 0.05) ratings were found for CAB products for multiple traits due to treatment disclosure, whereas the only non-CAB-branded product that received increased ( < 0.05) ratings during informed testing was 90/10 ground beef for tenderness and juiciness. Texture results indicated that decreased fat level increased hardness, cohesiveness, gumminess, and chewiness. These results indicate that when sampling ground beef without brand and product information, few consumers find differences in eating quality among ground beef treatments; however, when consumers are aware of the brand, fat level, and subprimal blend prior to sampling, these factors have a large impact on consumer eating satisfaction.

Effect of a Medicinal Agaricus blazei Murill-Based Mushroom Extract, AndoSan™, on Symptoms, Fatigue and Quality of Life in Patients with Ulcerative Colitis in a Randomized Single-Blinded Placebo Controlled Study

PubMed Central

Therkelsen, Stig Palm; Hetland, Geir; Lyberg, Torstein; Lygren, Idar; Johnson, Egil

2016-01-01

Background Ingestion of AndoSan™, based on the mushroom Agaricus blazei Murill, has previously been shown to exhibit anti-inflammatory effects because of reduction of pro-inflammatory cytokines in healthy individuals and patients with ulcerative colitis. In this randomized single-blinded placebo controlled study we examined whether intake of AndoSan™ also resulted in clinical effects. Methods and Findings 50 patients with symptomatic ulcerative colitis were block-randomized and blinded for oral daily intake of AndoSan™ or placebo for the 21 days’ experimental period. The patients reported scores for symptoms, fatigue and health related quality of life (HRQoL) at days 0, 14 and 21. Fecal calprotectin and general blood parameters were also analyzed. In the AndoSan™ group (n = 24) symptoms improved from baseline (day 0) to days 14 and 21, with respective mean scores (95% CI) of 5.88 (4.92–6.83), 4.71 (3.90–5.52) (p = 0.002) and 4.50 (3.70–5.30) (p = 0.001). Corresponding improved mean scores (±SD) for total fatigue were 16.6 (5.59), 14.1 (4.50) (p = 0.001) and 15.1 (4.09) (p = 0.023). These scores in the placebo group (n = 26) were not improved. When comparing the two study groups using mixed model statistics, we found significant better scores for the AndoSan™-patients. HRQoL for dimensions bodily pain, vitality, social functioning and mental health improved in the AndoSan™ group. There were no alterations in general blood samples and fecal calprotectin. Conclusions Beneficiary effects on symptoms, fatigue and HRQoL from AndoSan™ consumption were demonstrated in this per-protocol study, supporting its use as a supplement to conventional medication for patients with mild to moderate symptoms from ulcerative colitis. The patients did not report any harms or unintended effects of AndoSan™ in this study. Trial Registration ClinicalTrials.gov NCT01496053 PMID:26933886

Lisdexamfetamine dimesylate in adults with attention-deficit/ hyperactivity disorder who report clinically significant impairment in executive function: results from a randomized, double-blind, placebo-controlled study.

PubMed

Adler, Lenard A; Dirks, Bryan; Deas, Patrick F; Raychaudhuri, Aparna; Dauphin, Matthew R; Lasser, Robert A; Weisler, Richard H

2013-07-01

Behavioral rating scales that assess impairments in executive function commonly associated with attention-deficit/hyperactivity disorder (ADHD) may offer advantages over neuropsychological testing. The primary objective of this study was to evaluate the efficacy of lisdexamfetamine dimesylate for executive function deficits in adults with ADHD and clinically significant executive function impairment using self-reported Behavior Rating Inventory of Executive Function-Adult version (BRIEF-A) assessments. This randomized double-blind study, conducted between May 2010 and November 2010, screened at least 1 participant at 35 of 39 registered US clinical research sites. Adults (aged 18-55 years) with a primary ADHD diagnosis (meeting full DSM-IV-TR criteria) and executive function deficits (assessed by baseline BRIEF-A Global Executive Composite [GEC] T-scores of at least 65) were randomized to treatment with optimized lisdexamfetamine dimesylate (30 mg/d, 50 mg/d, or 70 mg/d; n = 80) or placebo (n = 81) during a 10-week double-blind treatment period. Outcome measures included the BRIEF-A scales (GEC, index, and clinical subscales). At week 10 or at early termination, lisdexamfetamine dimesylate was associated with significantly greater reductions from baseline in mean BRIEF-A GEC T-scores than placebo (effect size, 0.74; P < .0001) and significantly greater reductions from baseline in mean T-scores for both BRIEF-A index scales (Behavioral Regulation Index and Metacognition Index) and all 9 clinical subscales (P ≤ .0056 for all). At week 10 or at early termination, mean T-scores for BRIEF-A indexes and clinical subscales were below levels of clinically significant executive function deficits (ie, < 65) with lisdexamfetamine dimesylate treatment. The mean (SD) GEC T-score was 57.2 (14.11) for the lisdexamfetamine dimesylate group and 68.3 (17.12) for the placebo group. The safety profile of lisdexamfetamine dimesylate was consistent with other long-acting psychostimulants. Among adults with ADHD and clinically significant executive function deficits, lisdexamfetamine dimesylate was associated with significant improvements in self-reported executive function ratings. ClinicalTrials.gov identifier: NCT01101022. © Copyright 2013 Physicians Postgraduate Press, Inc.

Monoid sublingual immunotherapy.

PubMed

Palma-Carlos, A G; Santos, A S; Branco-Ferreira, M; Pregal, A L; Palma-Carlos, M L

2006-03-01

Sublingual monoid immunotherapy with monomeric allergoids has been largely used in Europe in the last few years. An open trial of allergoid in tablets has been done in rhinitic patients allergic to house dust mites, grass pollens and Parietaria with clear improvement in clinics and drug consumption scores. In a second phase a double blind placebo controlled trial of grass pollens allergoids have been done in hay fever patients with significant decrease on the scores of rhinorrea, sneezing and conjunctivitis nasal steroid consumption and clinical score after serial nasal challenges. Monomeric allergoids are an efficace and safe immunotherapy in allergic rhinitis.

Machine learning for the New York City power grid.

PubMed

Rudin, Cynthia; Waltz, David; Anderson, Roger N; Boulanger, Albert; Salleb-Aouissi, Ansaf; Chow, Maggie; Dutta, Haimonti; Gross, Philip N; Huang, Bert; Ierome, Steve; Isaac, Delfina F; Kressner, Arthur; Passonneau, Rebecca J; Radeva, Axinia; Wu, Leon

2012-02-01

Power companies can benefit from the use of knowledge discovery methods and statistical machine learning for preventive maintenance. We introduce a general process for transforming historical electrical grid data into models that aim to predict the risk of failures for components and systems. These models can be used directly by power companies to assist with prioritization of maintenance and repair work. Specialized versions of this process are used to produce 1) feeder failure rankings, 2) cable, joint, terminator, and transformer rankings, 3) feeder Mean Time Between Failure (MTBF) estimates, and 4) manhole events vulnerability rankings. The process in its most general form can handle diverse, noisy, sources that are historical (static), semi-real-time, or realtime, incorporates state-of-the-art machine learning algorithms for prioritization (supervised ranking or MTBF), and includes an evaluation of results via cross-validation and blind test. Above and beyond the ranked lists and MTBF estimates are business management interfaces that allow the prediction capability to be integrated directly into corporate planning and decision support; such interfaces rely on several important properties of our general modeling approach: that machine learning features are meaningful to domain experts, that the processing of data is transparent, and that prediction results are accurate enough to support sound decision making. We discuss the challenges in working with historical electrical grid data that were not designed for predictive purposes. The “rawness” of these data contrasts with the accuracy of the statistical models that can be obtained from the process; these models are sufficiently accurate to assist in maintaining New York City’s electrical grid.

Comparison of topical ropivacaine with and without ketamine on post-surgical pain in children undergoing tonsillectomy: a randomized controlled double-blind study.

PubMed

Hong, Boohwi; Lim, Chae Seong; Kim, Yoon-Hee; Lee, Jung Un; Kim, Yong Min; Jung, Choonho; Jo, Yumin

2017-08-01

Tonsillectomy in pediatric patients may cause severe postoperative pain. Topical local anesthetics are an easy and safe way to control post-tonsillectomy pain, but there is no benefit during the early postoperative stage. Topical ketamine shows a good effect on early stage postoperative pain. We compared the effect of topical ropivacaine with and without ketamine on post-tonsillectomy pain. Patients aged 3-7 years undergoing tonsillectomy were selected to participate in the study. Our study was performed in a randomized, placebo-controlled, double-blind manner. Patients were randomly assigned to one of two groups using computer-generated random numbers. The researchers who assessed the pain score, the caregivers, and the patient were blinded to group assignment. One group received topical ropivacaine with saline (RS group) and the other group received topical ropivacaine with 20 mg ketamine (RK group) on the tonsillar bed. Pain scores using the modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS) at 15 min and 30 min, and at 1, 2, 4, 8, 16 and 24 h were recorded. Rescue analgesic requirement and complications were also recorded. A total of 66 patients were randomly assigned to the RS group (n = 33) and the RK group (n = 33). The mCHEOPS scores were significantly lower in the RK group at 15 min (P = 0.046). The mCHEOPS scores of the two groups decreased with time, but there was no intergroup interaction. The RS group received more analgesics until 1 h after surgery and the RK group received more analgesics during 1-24 h after surgery. There were no differences in adverse outcomes. Topical ropivacaine with ketamine can reduce immediate postoperative pain and analgesic requirement better than ropivacaine alone.

Infliximab for chronic cutaneous sarcoidosis: a subset analysis from a double-blind randomized clinical trial.

PubMed

Baughman, Robert P; Judson, Marc A; Lower, Elyse E; Drent, Marjolein; Costabel, Ulrich; Flavin, Susan; Lo, Kim Hung; Barnathan, Elliot S

2016-01-15

Limited evidence exists demonstrating an effective treatment for chronic cutaneous sarcoidosis. To determine infliximab's effectiveness in sarcoidosis. We conducted a subset analysis from a randomized, double-blind, placebo-controlled trial for chronic pulmonary sarcoidosis to determine infliximab's effectiveness. Patients with chronic cutaneous sarcoidosis received infliximab (3 or 5 mg/kg) or placebo over 24 weeks. Of 138 patients, the subset analysis evaluated 17 patients with chronic facial and another 9 patients with nonfacial skin involvement. The SASI evaluated lesions for degree of erythema, desquamation, induration, and percentage of area involved. Facial and nonfacial lesions were scored in a blinded manner. Among 5 placebo-treated and 12 infliximab-treated patients, an improvement was observed with infliximab versus placebo in change from baseline to weeks 12 and 24 in desquamation (P<0.005) and induration (P<0.01) at week 24. Erythema, percentage of area involved and the evaluation of paired photographs did not reveal significant differences. Sample size; more extensive disease in placebo patients; chronic therapy upon enrollment; lung as primary organ of sarcoidosis involvement; limited investigator experience with SASI. Infliximab appears to be a beneficial treatment for chronic cutaneous sarcoidosis. The SASI scoring system demonstrated significant improvement versus placebo in lesion desquamation and induration.

Evaluation model of distribution network development based on ANP and grey correlation analysis

NASA Astrophysics Data System (ADS)

Ma, Kaiqiang; Zhan, Zhihong; Zhou, Ming; Wu, Qiang; Yan, Jun; Chen, Genyong

2018-06-01

The existing distribution network evaluation system cannot scientifically and comprehensively reflect the distribution network development status. Furthermore, the evaluation model is monotonous and it is not suitable for horizontal analysis of many regional power grids. For these reason, this paper constructs a set of universal adaptability evaluation index system and model of distribution network development. Firstly, distribution network evaluation system is set up by power supply capability, power grid structure, technical equipment, intelligent level, efficiency of the power grid and development benefit of power grid. Then the comprehensive weight of indices is calculated by combining the AHP with the grey correlation analysis. Finally, the index scoring function can be obtained by fitting the index evaluation criterion to the curve, and then using the multiply plus operator to get the result of sample evaluation. The example analysis shows that the model can reflect the development of distribution network and find out the advantages and disadvantages of distribution network development. Besides, the model provides suggestions for the development and construction of distribution network.

Comprehensive analysis and evaluation of big data for main transformer equipment based on PCA and Apriority

NASA Astrophysics Data System (ADS)

Guo, Lijuan; Yan, Haijun; Hao, Yongqi; Chen, Yun

2018-01-01

With the power supply level of urban power grid toward high reliability development, it is necessary to adopt appropriate methods for comprehensive evaluation of existing equipment. Considering the wide and multi-dimensional power system data, the method of large data mining is used to explore the potential law and value of power system equipment. Based on the monitoring data of main transformer and the records of defects and faults, this paper integrates the data of power grid equipment environment. Apriori is used as an association identification algorithm to extract the frequent correlation factors of the main transformer, and the potential dependence of the big data is analyzed by the support and confidence. Then, the integrated data is analyzed by PCA, and the integrated quantitative scoring model is constructed. It is proved to be effective by using the test set to validate the evaluation algorithm and scheme. This paper provides a new idea for data fusion of smart grid, and provides a reference for further evaluation of big data of power grid equipment.

[Ecologic evaluation in the cognitive assessment of brain injury patients: generation and execution of script].

PubMed

Baguena, N; Thomas-Antérion, C; Sciessere, K; Truche, A; Extier, C; Guyot, E; Paris, N

2006-06-01

Assessment of executive functions in an everyday life activity, evaluating brain injury subjects with script generation and execution tasks. We compared a script generation task to a script execution task, whereby subjects had to make a cooked dish. Two grids were used for the quotation, qualitative and quantitative, as well as the calculation of an anosognosis score. We checked whether the execution task was more sensitive to a dysexecutive disorder than the script generation task and compared the scores obtained in this evaluation with those from classical frontal tests. Twelve subjects with brain injury 6 years+/-4.79 ago and 12 healthy control subjects were tested. The subjects carried out a script generation task whereby they had to explain the necessary stages to make a chocolate cake. They also had to do a script execution task corresponding to the cake making. The 2 quotation grids were operational and complementary. The quantitative grid is more sensitive to a dysexecutive disorder. The brain injury subjects made more errors in the execution task. It is important to evaluate the executive functions of subjects with brain injury in everyday life tasks, not just in psychometric or script-generation tests. Indeed the ecological realization of a very simple task can reveal executive function difficulties such as the planning or the sequencing of actions, which are under-evaluated in laboratory tests.

Searching for moderators and mediators of pharmacological treatment effects in children and adolescents with anxiety disorders.

PubMed

Walkup, John T; Labellarte, Michael J; Riddle, Mark A; Pine, Daniel; Greenhill, Laurence; Klein, Rachel; Davies, Mark; Sweeney, Michael; Fu, Caifeng; Abikoff, Howard; Hack, Sabine; Klee, Brain; McCracken, James; Bergman, Lindsey; Piacentini, John; March, John; Compton, Scott; Robinson, James; O'Hara, Thomas; Baker, Sheryl; Vitiello, Benedetto; Ritz, Louise; Roper, Margaret

2003-01-01

To examine whether age, gender, ethnicity, type of anxiety disorder, severity of illness, comorbidity, intellectual level, family income, or parental education may function as moderators and whether treatment adherence, medication dose, adverse events, or blinded rater's guess of treatment assignment may function as mediators of pharmacological treatment effect in children and adolescents with anxiety disorders. The database of a recently reported double-blind placebo-controlled trial of fluvoxamine in 128 youths was analyzed. With a mixed-model random-effects regression analysis of the Pediatric Anxiety Rating Scale total score, moderators and mediators were searched by testing for a three-way interaction (strata by treatment by time). A two-way interaction (strata by time) identified predictors of treatment outcome. No significant moderators of efficacy were identified, except for lower baseline depression scores, based on parent's (but not child's) report, being associated with greater improvement (p < .001). Patients with social phobia (p < .05) and greater severity of illness (p < .001) were less likely to improve, independently of treatment assignment. Blinded rater's guess of treatment assignment acted as a possible mediator (p < .001), but improvement was attributed to fluvoxamine, regardless of actual treatment assignment. Treatment adherence tended to be associated (p = .05) with improvement. In this exploratory study, patient demographics, illness characteristics, family income, and parental education did not function as moderators of treatment effect. Social phobia and severity of illness predicted less favorable outcome. Attribution analyses indicated that study blindness remained intact. The presence of concomitant depressive symptoms deserves attention in future treatment studies of anxious children.

A multicenter randomized double-blind study on the efficacy and safety of nicergoline in patients with multi-infarct dementia.

PubMed

Herrmann, W M; Stephan, K; Gaede, K; Apeceche, M

1997-01-01

A 6-month double-blind, randomized, placebo-controlled clinical trial preceded by a 3-week single-blind, washout/run-in placebo phase was performed in male and female patients, 55-85 years of age with a clinical diagnosis of mild to moderate multi-infarct dementia according to DSM-III to evaluate the therapeutic efficacy and safety of nicergoline 30 mg b.i.d. Primary endpoints for efficacy were the changes in the Sandoz Clinical Assessment Geriatric Scale (SCAG) and Mini-Mental State Examination (MMSE) scores at the end of the treatment with respect to baseline. Secondary endpoints were Clinical Global Impression, 3 subtests of the Weschsler Adult Intelligence Scale and Blessed A scale for activities of daily living, and all endpoints in 2-month intervals. A total of 252 patients were screened, 136 patients entered the double-blind phase and were evaluated as intent-to-treat (ITT) patients. Fifteen patients were excluded from the efficacy analyses of valid cases (VC) due to protocol violations or because they dropped out of the study prematurely. Confirmatory efficacy analysis after 6 months of treatment revealed superiority of nicergoline treatment with p < 0.01 for both SCAG and MMSE scores (ITT and VC). Subsequent descriptive efficacy analysis resulted in significant differences in favor of nicergoline, in the majority of cases as early as 2 months after start of treatment. Nicergoline was well tolerated and a similar number of adverse events were observed in both the placebo and the nicergoline group.

Memantine as an Adjuvant Treatment for Obsessive Compulsive Symptoms in Manic Phase of Bipolar Disorder: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

PubMed

Sahraian, Ali; Jahromi, Leila Razeghian; Ghanizadeh, Ahmad; Mowla, Arash

2017-04-01

The aim of this study is to examine the effects of memantine as an adjuvant treatment for obsessive compulsive (OC) symptoms in patients with bipolar disorder (BD) type I, manic phase. In this 16-week double-blind placebo-controlled randomized clinical trial, 58 patients in the manic phase of BD who had OC symptoms were randomly allocated to receive memantine or placebo plus their routine medications (lithium + olanzapine + clonazepam). The Yale Brown Obsessive Compulsive Behavior Scale was used to assess the outcomes. Adverse effects were also recorded. Thirty-eight patients (19 in the memantine group and 19 in the placebo group) completed the trial. Throughout the trial, the mean score decreased from 20.26 ± 5.91 to 9.73 ± 5.44 in the memantine group (P < 0.000) and from 22.89 ± 5.70 to 16.63 ± 4.00 in the placebo group (P < 0.000). At the end of the study, 15 (78.94%) patients in the memantine group and 7 (36.84%) patients in the placebo group demonstrated more than 34% decline in the Yale Brown Obsessive Compulsive Behavior Scale score (P < 0.01). No serious adverse effects were reported. Our double-blind controlled clinical trial showed that memantine is an effective adjuvant agent for reducing OC symptoms in patients with BD. However, it needs to be noted that our study is preliminary, and larger double-blind controlled studies are needed to confirm the results.

36 CFR 701.6 - Loans of library materials for blind and other physically handicapped persons.

Code of Federal Regulations, 2010 CFR

2010-07-01

... their educational, vocational, and cultural opportunities in the field of music. Such scores, texts, and..., instructional texts, and other specialized materials, preference shall be at all times given to the needs of the...

Preliminary effects of oral uridine on the ocular surface in dry eye patients.

PubMed

Chang, Ki Cheol; Oh, Joo Youn; In, Youn Seok; Kim, Mee Kum; Shin, Ki Cheul; Wee, Won Ryang; Lee, Jin Hak; Park, Myung Gyu

2009-08-01

We designed a randomized, double blinded, 3-months controlled prospective clinical study to investigate effects of oral uridine on the ocular surface in dry eye patients. Twenty-seven patients who diagnosed as dry eye with lower than 5 mm of wetting in the Schirmer strip, with corneal epithelial erosion and who completely followed-up till 3 months were enrolled. Corneal-conjunctival fluorescein staining, non-anesthetic Schirmer test, impression cytology, and Ocular Surface Disease Index (OSDI) were evaluated in the experimental and placebo groups at the baseline, 1 and 3 months after start of medication in a double blinded manner. Fluorescein stain score of the cornea was markedly decreased in oral uridine group compared to the placebo group at 3 months after medication (P=0.032, Mann-Whitney U test). The Schirmer wetting score for the oral uridine group was significantly increased (P=0.001, Wilcoxon signed rank test) at 3 months and its difference between two groups was statistically significant (P=0.030, Mann-Whitney U test). OSDI scores were significantly decreased at 1 and 3 months in treatment group. Oral uridine is effective in treatment of dry eyes.

Double-blind crossover study of branched-chain amino acid therapy in patients with spinocerebellar degeneration.

PubMed

Mori, Masatada; Adachi, Yoshiki; Mori, Nozomi; Kurihara, Saiko; Kashiwaya, Yoshihiro; Kusumi, Masayoshi; Takeshima, Takao; Nakashima, Kenji

2002-03-30

To determine whether treatment with branched-chain amino acids (BCAA) can improve the condition of patients with ataxia, a double-blind crossover study of BCAA therapy was performed in 16 patients with spinocerebellar degeneration (SCD). The patients were treated with BCAA in oral doses of 1.5, 3.0, or 6.0 g or with placebo daily for 4 weeks in each study phase. The order of treatment phases (placebo or BCAA) was assigned randomly. An International Cooperative Ataxia Rating Scale (ICARS) was used to quantify the severity of symptoms of SCD. The mean ICARS score improved significantly with BCAA treatment compared with the mean pretreatment score (p<0.01). In addition, the improvement in the mean global ICARS score was significant in the middle-dose group compared with that in the placebo group (p<0.02). The estimated improvement in kinetic functions compared with pretreatment (p<0.01) was significant after treatment with BCAA, 1.5 and 3.0 g. All of the responders manifested predominantly cerebellar symptoms, especially those with spinocerebellar ataxia type 6 (SCA6). Thus, treatment with BCAA may be effective in patients with the cerebellar form of SCD.

Unilateral pedunculopontine stimulation improves falls in Parkinson's disease.

PubMed

Moro, Elena; Hamani, Clement; Poon, Yu-Yan; Al-Khairallah, Thamar; Dostrovsky, Jonathan O; Hutchison, William D; Lozano, Andres M

2010-01-01

Postural instability and falls are a major source of disability in patients with advanced Parkinson's disease. These problems are currently not well addressed by either pharmacotherapy nor by subthalamic nucleus deep-brain stimulation surgery. The neuroanatomical substrates of posture and gait are poorly understood but a number of important observations suggest a major role for the pedunculopontine nucleus and adjacent areas in the brainstem. We conducted a double-blinded evaluation of unilateral pedunculopontine nucleus deep-brain stimulation in a pilot study in six advanced Parkinson's disease patients with significant gait and postural abnormalities. There was no significant difference in the double-blinded on versus off stimulation Unified Parkinson's Disease Rating Scale motor scores after 3 or 12 months of continuous stimulation and no improvements in the Unified Parkinson's Disease Rating Scale part III scores compared to baseline. In contrast, patients reported a significant reduction in falls in the on and off medication states both at 3 and 12 months after pedunculopontine nucleus deep-brain stimulation as captured in the Unified Parkinson's Disease Rating Scale part II scores. Our results suggest that pedunculopontine nucleus deep-brain stimulation may be effective in preventing falls in patients with advanced Parkinson's disease but that further evaluation of this procedure is required.

Transdermal rotigotine in early stage Parkinson's disease: a randomized, double-blind, placebo-controlled trial.

PubMed

Mizuno, Yoshikuni; Nomoto, Masahiro; Kondo, Tomoyoshi; Hasegawa, Kazuko; Murata, Miho; Takeuchi, Masahiro; Ikeda, Junji; Tomida, Takayuki; Hattori, Nobutaka

2013-09-01

We conducted a randomized, double-blind, placebo-controlled trial to determine the safety and efficacy of transdermal rotigotine at doses up to 16 mg/24 hours in patients with early stage Parkinson's disease (PD) in Japan. Patients received once-daily rotigotine 2 to 16 mg/24 hours (mean dose, 12.8 mg/24 hours; n = 82) or placebo (n = 90) for 12 weeks. The primary endpoint was the change in Unified Parkinson's Disease Rating Scale (UPDRS) part II (activities of daily living) and part III (motor function) scores from baseline to the end of treatment. The mean (± standard deviation) changes in UPDRS part II and III scores were -8.4 ± 9.7 in the rotigotine group and -4.1 ± 8.2 in the placebo group and were significantly different (P = 0.002). More patients in the rotigotine group than in the placebo group had a ≥ 20% score reduction. No serious drug-related adverse events were reported. Rotigotine at doses up to 16 mg/24 hours was well tolerated and improved function in patients with early stage PD. © 2013 International Parkinson and Movement Disorder Society.

Comparison of ziprasidone and aripiprazole in acutely ill patients with schizophrenia or schizoaffective disorder: a randomized, double-blind, 4-week study.

PubMed

Zimbroff, Dan; Warrington, Lewis; Loebel, Antony; Yang, Ruoyong; Siu, Cynthia

2007-11-01

We compared the efficacy and safety of ziprasidone and aripiprazole in the treatment of acutely ill patients with schizophrenia. Patients were randomized to receive double-blind treatment with ziprasidone (80-160 mg/day), or aripiprazole (10-30 mg/day) for up to 4 weeks. Primary efficacy measures were the Clinical Global Impression of Severity scale (CGI-S) and Brief Psychiatric Rating Scale (BPRSd) total (derived from the Positive and Negative Syndrome Scale). Noninferiority for ziprasidone (N=125) relative to aripiprazole (N=128) was established for CGI-S score (P=0.007), but was not confirmed for BPRSd total score (P=0.248). Effect sizes for within-group improvement, however, were robust for both ziprasidone and aripiprazole (effect size range 1.0-1.1 for CGI-S; and range 1.1-1.2 for BPRSd total). A mixed model repeated measures analysis of BPRSd total score favored ziprasidone at day 4 compared with aripiprazole (P=0.04), with no significant differences between treatment groups at other visits (P=0.001 for interaction between treatment and visit). No statistically significant difference was found in CGI-S score between groups across all visits. Our findings suggest that ziprasidone and aripiprazole exhibit similar efficacy and tolerability profiles in the treatment of acute schizophrenia. Differences between the two drugs in the onset of therapeutic effect warrant further investigation.

Efficacy of the device combining high-frequency transcutaneous electrical nerve stimulation and thermotherapy for relieving primary dysmenorrhea: a randomized, single-blind, placebo-controlled trial.

PubMed

Lee, Banghyun; Hong, Seung Hwa; Kim, Kidong; Kang, Wee Chang; No, Jae Hong; Lee, Jung Ryeol; Jee, Byung Chul; Yang, Eun Joo; Cha, Eun-Jong; Kim, Yong Beom

2015-11-01

To investigate the efficacy and safety of the combined therapy with high-frequency transcutaneous electrical nerve stimulation (hf-TENS) and thermotherapy in relieving primary dysmenorrheal pain. In this randomized, single-blind, placebo-controlled study, 115 women with moderate or severe primary dysmenorrhea were assigned to the study or control group at a ratio of 1:1. Subjects in the study group used an integrated hf-TENS/thermotherapy device, whereas control subjects used a sham device. A visual analog scale was used to measure pain intensity. Variables related to pain relief, including reduction rate of dysmenorrheal score, were compared between the groups. The dysmenorrheal score was significantly reduced in the study group compared to the control group following the use of the devices. The duration of pain relief was significantly increased in the study group compared to the control group. There were no differences between the groups in the brief pain inventory scores, numbers of ibuprofen tablets taken orally, and World Health Organization quality of life-BREF scores. No adverse events were observed related to the use of the study device. The combination of hf-TENS and thermotherapy was effective in relieving acute pain in women with moderate or severe primary dysmenorrhea. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Misoprostol in the treatment of tinnitus: a double-blind study.

PubMed

Yilmaz, Ismail; Akkuzu, Babür; Cakmak, Ozcan; Ozlüoglu, Levent N

2004-05-01

To test the efficacy of misoprostol as a treatment for tinnitus. A prospective, placebo-controlled, double-blind study. Başkent University Otolaryngology Clinic. Forty adult patients who had had tinnitus for a minimum of 6 months and were free of systemic or otolaryngologic disease. Twenty-eight patients were randomly assigned to the experimental group (group I) and 12 to the control group (group II). The respective groups received active drug and placebo in increasing doses for 4 months. The effect of medications on tinnitus were evaluated by determining improvement rates in tinnitus loudness and subjective tinnitus scoring. In the experimental group, 18 of 28 patients showed improvement in tinnitus loudness, representing an improvement rate of 64%. The improvement rate based on subjective tinnitus scoring was 36% (10 of 28 patients). In the control group, the improvement rate for tinnitus loudness was 33% (n = 4), and the rate for subjective tinnitus scoring was 17% (n = 2). The difference between improvement rate for tinnitus loudness of the experimental group and control group was found to be statistically significant (P = 0.039), but difference between improvement rate based on subjective tinnitus scoring was insignificant (P = 0.119). When results in the experimental group were analyzed according to etiological factors, the improvement rate was highest in the sudden-onset subgroup (77%). Misoprostol provided therapeutic relief for some patients with tinnitus we studied, but further investigation of larger groups is needed.

The effects of alcohol mixed with energy drink (AMED) on subjective intoxication and alertness: results from a double-blind placebo-controlled clinical trial.

PubMed

van de Loo, Aurora J A E; van Andel, Nienke; van Gelder, Charlotte A G H; Janssen, Boris S G; Titulaer, Joep; Jansen, Jimmy; Verster, Joris C

2016-05-01

The purpose of this double blind placebo controlled study was to examine if specific effects on subjective intoxication and alertness-sleepiness ratings could be demonstrated after consuming alcohol mixed with energy drink (AMED) when compared to consuming alcohol only (AO). 56 healthy volunteers rated their subjective intoxication on a scale ranging from 0 (sober) to 10 (highly intoxicated) at baseline, breath alcohol concentration (BAC) of 0%, and at BAC 0.08%, 0.05%, and 0.02%. Alertness-sleepiness was assessed with the Karolinska sleepiness scale. Scores of the AMED and AO condition, at each BAC level, were compared. Subjective intoxication for AMED and AO did not differ significantly from each other at any BAC level, except for BAC 0.02%. A significant increase in sleepiness scores was found in the AO condition, whereas scores remained stable in the AMED condition. Sleepiness scores at BAC0.08% and 0.05% were significantly lower after AMED when compared to AO. However, the observed differences between AMED and AO were small and have no clinical relevance. Mixing alcohol with energy drink had no overall masking effect on subjective intoxication caused by alcohol, nor had a relevant effect on subjective alertness-sleepiness ratings. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Use of honey associated with Ananas comosus (Bromelin) in the treatment of acute irritative cough.

PubMed

Peixoto, Décio Medeiros; Rizzo, José Angelo; Schor, Deborah; Silva, Almerinda Rêgo; Oliveira, Dinaldo Cavalcanti de; Solé, Dirceu; Sarinho, Emanuel

2016-12-01

To evaluate the immediate improvement rate of irritative cough in patients treated with the combination of Ananas comosus extract and honey (Bromelin ® ) compared with the use of honey alone (placebo group). Pragmatic, double-blind, randomized, parallel-group study with children aged between 2 and 15 years, with irritative cough for at least 24hours. The double-blind assessment of cough was through the number of observed coughing episodes and intensity score for a period of 10minutes of observation. The decrease of one point in the mean total score was considered as a therapeutic effect. There was a reduction in coughing episodes in both groups, as well as in the cough score after 30minutes of drug or honey administration. The change in clinical score above two points, which could indicate marked improvement, occurred in five patients in the bromelin group and only in one in the placebo group, but without significant difference. There were no adverse events. The immediate improvement rate of irritative cough was similar in patients treated with combination of Ananas comosus extract and honey (Bromelin ® ) compared with the use of honey alone (placebo group). It is possible that honey has a therapeutic effect on mucus and cough characteristics (Clinical Trials: NCT01356693). Copyright © 2016 Sociedade de Pediatria de São Paulo. Publicado por Elsevier Editora Ltda. All rights reserved.

A double-blind, randomized, placebo-controlled trial of the effect of testosterone cream on the sexual motivation of menopausal hysterectomized women with hypoactive sexual desire disorder.

PubMed

El-Hage, G; Eden, J A; Manga, R Zoa

2007-08-01

To assess the safety and efficacy of 10 mg topical testosterone therapy daily (2 cm Andro-Feme cream) as a treatment for low sexual desire in postmenopausal hysterectomized women who were already on transdermal estrogen. A double-blind, randomized, placebo-controlled, cross-over study (each period being of 3 months' duration) was performed in the research center of a tertiary referral women's hospital. Thirty-six menopausal healthy women were recruited who had undergone a hysterectomy, who were not depressed, were in a stable relationship and who fulfilled diagnostic criteria for low sexual desire, as measured by the Brief Index of Sexual Function for Women (BISF-W). The primary outcome measure was improvement in the sexuality score as measured by a validated tool (BISF-W); secondary measures were sub-scores of the BISF-W, effect on mood and energy, lipids and testosterone levels. Testosterone cream significantly improved sexual desire, frequency of sex, receptivity and initiation as measured by the BISF-W score. It did not change mood, energy, lipids, blood pressure or weight over the study period. Testosterone cream significantly improved sexual scores in menopausal women with low sexual desire. It was effective, easy to use and had no side-effects over the 3-month period of active treatment. It offers a novel and acceptable method of administering testosterone to menopausal women.

Randomized, double-blind, placebo-controlled trial of saw palmetto in men with lower urinary tract symptoms.

PubMed

Gerber, G S; Kuznetsov, D; Johnson, B C; Burstein, J D

2001-12-01

To assess the effects of saw palmetto on urinary symptoms, sexual function, and urinary flow rate in men with lower urinary tract symptoms using a double-blind, randomized, placebo-controlled trial. The eligible patients were 45 years of age or older and had an International Prostate Symptom Score of 8 or greater. After a 1-month placebo run-in period, 85 men were randomized to receive saw palmetto or placebo for 6 months. Patients were evaluated using the International Prostate Symptom Score, a sexual function questionnaire, and by measurement of the urinary flow rate. The mean symptom score decreased from 16.7 to 12.3 in the saw palmetto group compared with 15.8 to 13.6 in the placebo group (P = 0.038). The quality-of-life score improved to a greater degree in the saw palmetto group, but this difference was not statistically significant. No change occurred in the sexual function questionnaire results in either group. The peak flow rate increased by 1.0 mL/s and 1.4 mL/s in the saw palmetto and placebo groups, respectively (P = 0.73). Saw palmetto led to a statistically significant improvement in urinary symptoms in men with lower urinary tract symptoms compared with placebo. Saw palmetto had no measurable effect on the urinary flow rates. The mechanism by which saw palmetto improves urinary symptoms remains unknown.

Comparison of the Diagnostic Image Quality of the Canine Maxillary Dentoalveolar Structures Obtained by Cone Beam Computed Tomography and 64-Multidetector Row Computed Tomography.

PubMed

Soukup, Jason W; Drees, Randi; Koenig, Lisa J; Snyder, Christopher J; Hetzel, Scott; Miles, Chanda R; Schwarz, Tobias

2015-01-01

The objective of this blinded study was to validate the use of cone beam computed tomography (C) for imaging of the canine maxillary dentoalveolar structures by comparing its diagnostic image quality with that of 64-multidetector row CT Sagittal slices of a tooth-bearing segment of the maxilla of a commercially purchased dog skull embedded in methylmethacrylate were obtained along a line parallel with the dental arch using a commercial histology diamond saw. The slice of tooth-bearing bone that best depicted the dentoalveolar structures was chosen and photographed. The maxillary segment was imaged with cone beam CT and 64-multidetector row CT. Four blinded evaluators compared the cone beam CT and 64-multidetector row CT images and image quality was scored as it related to the anatomy of dentoalveolar structures. Trabecular bone, enamel, dentin, pulp cavity, periodontal ligament space, and lamina dura were scored In addition, a score depicting the evaluators overall impression of the image was recorded. Images acquired with cone beam CT were found to be significantly superior in image quality to images acquired with 64-multidetector row CT overall, and in all scored categories. In our study setting cone beam CT was found to be a valid and clinically superior imaging modality for the canine maxillary dentoalveolar structures when compared to 64-multidetector row CT.

Comparison of the Diagnostic Image Quality of the Canine Maxillary Dentoalveolar Structures Obtained by Cone Beam Computed Tomography and 64-Multidetector Row Computed Tomography

PubMed Central

Soukup, Jason W.; Drees, Randi; Koenig, Lisa J.; Snyder, Christopher J.; Hetzel, Scott; Miles, Chanda R.; Schwarz, Tobias

2016-01-01

Summary The objective of this blinded study was to validate the use of cone beam computed tomography (CT) for imaging of the canine maxillary dentoalveolar structures by comparing its diagnostic image quality with that of 64-multidetector row CT. Sagittal slices of a tooth-bearing segment of the maxilla of a commercially purchased dog skull embedded in methyl methacrylate were obtained along a line parallel with the dental arch using a commercial histology diamond saw. The slice of tooth-bearing bone that best depicted the dentoalveolar structures was chosen and photographed. The maxilla segment was imaged with cone beam CT and 64-multidetector row CT. Four blinded evaluators compared the cone beam CT and 64-multidetector row CT images and image quality was scored as it related to the anatomy of dentoalveolar structures. Trabecular bone, enamel, dentin, pulp cavity, periodontal ligament space, and lamina dura were scored. In addition, a score depicting the evaluators overall impression of the image was recorded. Images acquired with cone beam CT were found to be significantly superior in image quality to images acquired with 64-multidetector row CT overall, and in all scored categories. In our study setting, cone beam CT was found to be a valid and clinically superior imaging modality for the canine maxillary dentoalveolar structures when compared to 64-multidetector row CT. PMID:26415384

Medial Entorhinal Grid Cells and Head Direction Cells Rotate with a T-Maze More Often During Less Recently Experienced Rotations

PubMed Central

Gupta, Kishan; Beer, Nathan J.; Keller, Lauren A.; Hasselmo, Michael E.

2014-01-01

Prior studies of head direction (HD) cells indicate strong landmark control over the preferred firing direction of these cells, with few studies exhibiting shifts away from local reference frames over time. We recorded spiking activity of grid and HD cells in the medial entorhinal cortex of rats, testing correlations of local environmental cues with the spatial tuning curves of these cells' firing fields as animals performed continuous spatial alternation on a T-maze that shared the boundaries of an open-field arena. The environment was rotated into configurations the animal had either seen or not seen in the past recording week. Tuning curves of both cell types demonstrated commensurate shifts of tuning with T-maze rotations during less recent rotations, more so than recent rotations. This strongly suggests that animals are shifting their reference frame away from the local environmental cues over time, learning to use a different reference frame more likely reliant on distal or idiothetic cues. In addition, grid fields demonstrated varying levels of “fragmentation” on the T-maze. The propensity for fragmentation does not depend on grid spacing and grid score, nor animal trajectory, indicating the cognitive treatment of environmental subcompartments is likely driven by task demands. PMID:23382518

Long-term efficacy and safety of a combination of sabal and urtica extract for lower urinary tract symptoms--a placebo-controlled, double-blind, multicenter trial.

PubMed

Lopatkin, N; Sivkov, A; Walther, C; Schläfke, S; Medvedev, A; Avdeichuk, J; Golubev, G; Melnik, K; Elenberger, N; Engelmann, U

2005-06-01

The efficacy and tolerability of a fixed combination of 160 mg sabal fruit extract WS 1473 and 120 mg urtica root extract WS 1031 per capsule (PRO 160/120) was investigated in elderly, male patients suffering from lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia in a prospective multicenter trial. A total of 257 patients (129 and 128, respectively) were randomized to treatment with PRO 160/120 or placebo (127 and 126 were evaluable for efficacy). Following a single-blind placebo run-in phase of 2 weeks, the patients received 2 x 1 capsule/day of the study medication under double-blind conditions over a period of 24 weeks. Double-blind treatment was followed by an open control period of 24 weeks during which all patients were administered PRO 160/120. Outcome measures for treatment efficacy included the assessment of the patients' LUTS by means of the I-PSS self-rating questionnaire and a quality of life index as well as uroflow and sonographic parameters. Using the International Prostate Symptom Score (I-PSS), patients treated with PRO 160/120 exhibited a substantially higher total score reduction after 24 weeks of double-blind treatment than patients of the placebo group (6 points vs 4 points; P=0.003, one tailed) with a tendency in the same direction after 16 weeks. This applied to obstructive as well as to irritative symptoms, and to patients with moderate or severe symptoms at baseline. Patients randomized to placebo showed a marked improvement in LUTS (as measured by the I-PSS) after being switched to PRO 160/120 during the control period (P=0.01, one tailed, in comparison to those who had been treated with PRO 160/120 in the double-blind phase). The tolerability of PRO 160/120 was comparable to the placebo. In conclusion, PRO 160/120 was clearly superior to the placebo for the amelioration of LUTS as measured by the I-PSS. PRO 160/120 is advantageous in obstructive and irritative urinary symptoms and in patients with moderate and severe symptoms. The tolerability of the herbal extract was excellent.

l-Carnosine As an Adjunctive Therapy to Risperidone in Children with Autistic Disorder: A Randomized, Double-Blind, Placebo-Controlled Trial.

PubMed

Hajizadeh-Zaker, Reihaneh; Ghajar, Alireza; Mesgarpour, Bita; Afarideh, Mohsen; Mohammadi, Mohammad-Reza; Akhondzadeh, Shahin

2018-02-01

This study aimed at investigating the efficacy and tolerability of l-carnosine as an add-on to risperidone in the management of children with autism. This was a 10-week, randomized, double-blind, placebo-controlled study. Seventy drug-free children aged 4-12 years old with a diagnosis of autism spectrum disorder (ASD), according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition. (DSM-5) who had an Aberrant Behavior Checklist-Community (ABC-C) scale irritability subscale score of ≥12, entered the study. The patients were randomly assigned to l-carnosine (800 mg/day in 2 divided doses) or placebo in addition to risperidone titrated up to 2 mg/day (based on body weight) for 10 weeks. The children were assessed by using ABC-C at baseline and weeks 5 and 10 post-baseline. The primary outcome measure was the mean change in the ABC-C irritability subscale score, and other subscale scores were defined as secondary outcomes. Using the general linear model repeated measures, no significant effect was observed for time × treatment interaction on the irritability subscale scores. However, significant effect was detected on the hyperactivity/noncompliance subscale [F (1.62, 64.96) = 3.53, p-value = 0.044]. No significant improvements were obtained on the lethargy/social withdrawal, stereotypic behavior, and inappropriate speech subscale scores. Significantly greater score reduction in the hyperactivity/noncompliance subscale occurred in the l-carnosine group compared with the placebo group at the end of the trial. Extrapyramidal Symptom Rating Scale Scores and its changes did not differ between the two groups. The frequency of other side effects was not significantly different between the two groups. Although no significant difference was detected on the irritability subscale scores, l-carnosine add-on can improve hyperactivity/noncompliance subscales of the ABC-C rating scale in patients with ASD.

The Surveillance Error Grid

PubMed Central

Lias, Courtney; Vigersky, Robert; Clarke, William; Parkes, Joan Lee; Sacks, David B.; Kirkman, M. Sue; Kovatchev, Boris

2014-01-01

Introduction: Currently used error grids for assessing clinical accuracy of blood glucose monitors are based on out-of-date medical practices. Error grids have not been widely embraced by regulatory agencies for clearance of monitors, but this type of tool could be useful for surveillance of the performance of cleared products. Diabetes Technology Society together with representatives from the Food and Drug Administration, the American Diabetes Association, the Endocrine Society, and the Association for the Advancement of Medical Instrumentation, and representatives of academia, industry, and government, have developed a new error grid, called the surveillance error grid (SEG) as a tool to assess the degree of clinical risk from inaccurate blood glucose (BG) monitors. Methods: A total of 206 diabetes clinicians were surveyed about the clinical risk of errors of measured BG levels by a monitor. The impact of such errors on 4 patient scenarios was surveyed. Each monitor/reference data pair was scored and color-coded on a graph per its average risk rating. Using modeled data representative of the accuracy of contemporary meters, the relationships between clinical risk and monitor error were calculated for the Clarke error grid (CEG), Parkes error grid (PEG), and SEG. Results: SEG action boundaries were consistent across scenarios, regardless of whether the patient was type 1 or type 2 or using insulin or not. No significant differences were noted between responses of adult/pediatric or 4 types of clinicians. Although small specific differences in risk boundaries between US and non-US clinicians were noted, the panel felt they did not justify separate grids for these 2 types of clinicians. The data points of the SEG were classified in 15 zones according to their assigned level of risk, which allowed for comparisons with the classic CEG and PEG. Modeled glucose monitor data with realistic self-monitoring of blood glucose errors derived from meter testing experiments plotted on the SEG when compared to the data plotted on the CEG and PEG produced risk estimates that were more granular and reflective of a continuously increasing risk scale. Discussion: The SEG is a modern metric for clinical risk assessments of BG monitor errors that assigns a unique risk score to each monitor data point when compared to a reference value. The SEG allows the clinical accuracy of a BG monitor to be portrayed in many ways, including as the percentages of data points falling into custom-defined risk zones. For modeled data the SEG, compared with the CEG and PEG, allows greater precision for quantifying risk, especially when the risks are low. This tool will be useful to allow regulators and manufacturers to monitor and evaluate glucose monitor performance in their surveillance programs. PMID:25562886

The surveillance error grid.

PubMed

Klonoff, David C; Lias, Courtney; Vigersky, Robert; Clarke, William; Parkes, Joan Lee; Sacks, David B; Kirkman, M Sue; Kovatchev, Boris

2014-07-01

Currently used error grids for assessing clinical accuracy of blood glucose monitors are based on out-of-date medical practices. Error grids have not been widely embraced by regulatory agencies for clearance of monitors, but this type of tool could be useful for surveillance of the performance of cleared products. Diabetes Technology Society together with representatives from the Food and Drug Administration, the American Diabetes Association, the Endocrine Society, and the Association for the Advancement of Medical Instrumentation, and representatives of academia, industry, and government, have developed a new error grid, called the surveillance error grid (SEG) as a tool to assess the degree of clinical risk from inaccurate blood glucose (BG) monitors. A total of 206 diabetes clinicians were surveyed about the clinical risk of errors of measured BG levels by a monitor. The impact of such errors on 4 patient scenarios was surveyed. Each monitor/reference data pair was scored and color-coded on a graph per its average risk rating. Using modeled data representative of the accuracy of contemporary meters, the relationships between clinical risk and monitor error were calculated for the Clarke error grid (CEG), Parkes error grid (PEG), and SEG. SEG action boundaries were consistent across scenarios, regardless of whether the patient was type 1 or type 2 or using insulin or not. No significant differences were noted between responses of adult/pediatric or 4 types of clinicians. Although small specific differences in risk boundaries between US and non-US clinicians were noted, the panel felt they did not justify separate grids for these 2 types of clinicians. The data points of the SEG were classified in 15 zones according to their assigned level of risk, which allowed for comparisons with the classic CEG and PEG. Modeled glucose monitor data with realistic self-monitoring of blood glucose errors derived from meter testing experiments plotted on the SEG when compared to the data plotted on the CEG and PEG produced risk estimates that were more granular and reflective of a continuously increasing risk scale. The SEG is a modern metric for clinical risk assessments of BG monitor errors that assigns a unique risk score to each monitor data point when compared to a reference value. The SEG allows the clinical accuracy of a BG monitor to be portrayed in many ways, including as the percentages of data points falling into custom-defined risk zones. For modeled data the SEG, compared with the CEG and PEG, allows greater precision for quantifying risk, especially when the risks are low. This tool will be useful to allow regulators and manufacturers to monitor and evaluate glucose monitor performance in their surveillance programs. © 2014 Diabetes Technology Society.

Efficacy of a film-forming medical device containing sunscreen (50+) and piroxicam 0.8% in actinic keratosis and field cancerization: a multicenter, assessor-blinded, 3 month trial.

PubMed

Puviani, Mario; Galloni, Chiara; Marchetti, Silvia; Sergio Pavone, Paolo; Lovati, Silvia; Pistone, Giuseppe; Caputo, Valentina; Tilotta, Giovanna; Scarcella, Giuseppe; Campione, Elena; Diluvio, Laura; Garofalo, Virginia; Bianchi, Luca; Milani, Massimo

2017-07-01

Sunscreen protection in subjects with actinic keratosis (AK) is highly recommended to prevent clinical evolution of this in situ skin cancer condition. Use of topical anti-cyclooxygenase drugs such as diclofenac and piroxicam reduces the number of lesions and improves the cancerization field. A film-forming medical device in a cream formulation containing organic and inorganic sun-filters (50+ SPF) and piroxicam 0.8% (ACTX) has shown in a pilot, single-center, open trial to reduce AK lesions improving the cancerization field. We evaluated in a multicenter, assessor-blinded, 3 month trial the efficacy of ACTX in AK. A total of 70 subjects with at least three AK lesions on the scalp or face were enrolled after written informed consent. Primary outcomes of the study were the clinical evolution of number of AK lesions on a target zone area and the evolution of dermoscopy features of the target lesion, assessing erythema, scaling, pigmentation, and follicular plug, using a 5 point score (from 0 to 4; maximum score: 16). Lesion count and dermoscopy score were evaluated in a blind fashion assessing digital color high definition coded images. A secondary outcome was the Investigator Global Score (IGS) of clinical evolution of the target area using a 7 point scale from -2 (significantly worse) to +4 (completely cured). IGS was evaluated in an open fashion. Subjects were instructed to apply the cream twice daily on the target area, using one finger-tip unit for the treatment of a 35 cm 2 area. All but one subject (40 men and 30 women, mean age 73 years) concluded the study period. At baseline the mean (±SD) number of AK lesions in the target area were 7.0 (5.9) with a median value of 5 and the dermoscopy score of the target lesion was 7.0 (2.3) with a median value of 7.0. ACTX treatment reduced AK lesions to 3.2 (2.9), (p = .0001; Wilcoxon Test), representing a 55% relative reduction. Dermoscopy score was reduced to 3.3 (2.6) (p = .0001) (a reduction of 53%). The IGS after ACTX treatment was +1.9 (1.1), with a median of 2.0. A total of 86% of subjects showed a clinical improvement of IGS (≥1) with a very significant/complete clearance (score +3 or +4) in 42% subjects. No change or a worsening of AK lesions was observed in 14% of the subjects. The product was well tolerated. No serious adverse events were reported during the duration of the trial. In this multicenter, assessor-blinded trial, the use of a film-forming medical device with sun protection and anti-inflammatory actions was effective in reducing AK lesions and improving the dermoscopy aspect of the target lesion in 86% of treated subjects. A head-to-head trial evaluating the efficacy of this medical device in comparison with diclofenac is warranted to establish whether this therapeutic approach could offer additional advantages in term of AK lesion reduction compared to an established topical treatment. (Trial ID: ISRCTN72020277).

Double-blind, placebo-controlled immunotherapy with mixed grass-pollen allergoids. II. Comparison between parameters assessing the efficacy of immunotherapy.

PubMed

Bousquet, J; Maasch, H; Martinot, B; Hejjaoui, A; Wahl, R; Michel, F B

1988-09-01

Specific immunotherapy is effective in alleviating symptoms in grass pollen-induced rhinitis, but there are no clear data demonstrating a correlation between symptom-medication scores and objective parameters. Twenty-five patients taking part in a double-blind, placebo-controlled immunotherapy with mixed grass pollen-formalinized allergoids were studied. All patients had the same investigations. Symptom-medication scores were significantly (p less than 0.005, Mann-Whitney U test) reduced in the treated group by comparison to the placebo-treated patients. Nasal challenges performed with threefold increasing numbers of orchard grass-pollen grains demonstrated that patients treated with allergoid tolerated a significantly (p less than 0.005, Wilcoxon W test) greater number of grains after treatment, whereas there was no mean difference in the placebo-treated patients. There was a significant (p less than 0.005, Spearman rank-correlation) correlation between nasal challenges and symptom scores during the season. The skin prick test end point was significantly (p less than 0.001, Wilcoxon W test) reduced after treatment in the allergoid-treated group and remained unchanged in the placebo-treated group. There was a significant (p less than 0.001) correlation between the skin prick test end point and symptom scores during the season. Serum grass-pollen IgG titrated by a solid-phase radioimmunoassay with Staphylococcus A protein was significantly (p less than 0.01, Wilcoxon W test) increased after treatment with allergoid, but there was no significant correlation between IgG titer and symptom scores during the season. Serum grass-pollen IgE increased (p less than 0.04, Wilcoxon W test) in the treated group but there was no correlation with symptom scores.

Efficacy and safety of Xiangsha Liujunzi granules for functional dyspepsia: A multi-center randomized double-blind placebo-controlled clinical study

PubMed Central

Lv, Lin; Wang, Feng-Yun; Ma, Xiang-Xue; Li, Zhen-Hua; Huang, Sui-Ping; Shi, Zhao-Hong; Ji, Hai-Jie; Bian, Li-Qun; Zhang, Bei-Hua; Chen, Ting; Yin, Xiao-Lan; Tang, Xu-Dong

2017-01-01

AIM To assess the efficacy and safety of a Chinese herbal medicine (CHM), Xiangsha Liujunzi granules, in the treatment of patients with functional dyspepsia (FD). METHODS We performed a randomized, double-blind, placebo-controlled trial with patients from three centers. Two hundred and sixteen subjects diagnosed with FD according to ROME III criteria and confirmed by upper gastrointestinal endoscopy and spleen-deficiency and Qi-stagnation syndrome were selected to receive Xiangsha Liujunzi granules or placebo for 4 wk in a 2:1 ratio by blocked randomization. The subjects also received follow-up after the 4-wk intervention. Herbal or placebo granules were dissolved in 300 mL of water. Participants in both groups were administered 130 mL (45 °C) three times a day. Participants were evaluated prior to and following 4 wk of the intervention in terms of changes in the postprandial discomfort severity scale (PDSS) score, clinical global impression (CGI) scale score, hospital anxiety and depression scale (HADS) score, traditional Chinese medicine symptoms score (SS), scores of various domains of the 36-item short form health survey (SF-36), gastric emptying (GE) and any observed adverse effects. RESULTS Compared with the placebo group, patients in the CHM group showed significant improvements in the scores of PDSS, HADS, SS, SF-36 and CGI scale (P < 0.05 or P < 0.01). They also showed the amelioration in the GE rates of the proximal stomach and distal stomach (P < 0.05 or P < 0.01). CONCLUSION Xiangsha Liujunzi granules offered significant symptomatic improvement in patients with FD. PMID:28852318

The effect of balneotherapy on chronic shoulder pain. A randomized, controlled, single-blind follow-up trial. A pilot study.

PubMed

Tefner, Ildikó Katalin; Kovács, Csaba; Gaál, Ramóna; Koroknai, András; Horváth, Remény; Badruddin, Rakib Mohammed; Borbély, Ildikó; Nagy, Katalin; Bender, Tamás

2015-06-01

The effects of balneotherapy on chronic shoulder pain were studied. In this single-blind, randomized, follow-up study involving 46 patients with chronic shoulder pain, one group of patients received physiotherapy--exercise and transcutaneous electrical nerve stimulation--and the other group received balneotherapy in addition to physiotherapy for 4 weeks on 15 occasions. The following parameters were recorded before treatment (at week 0) and after treatment (at weeks 4, 7, and 13): Shoulder Pain and Disability Index (SPADI), the Short Form (36) Health Survey (SF-36) and EuroQuol-5D (EQ-5D) quality of life questionnaires, pain at rest and on movement on the visual analog scale (VAS), and active and passive range of motion. The SPADI pain, function, and total scores and the VAS scores at rest and on movement significantly improved in both groups after treatments. A greater improvement was observed in the balneotherapy group compared to the control group; regarding some parameters (VAS score on movement and SPADI function score at visit 2; VAS score at rest at visits 3 and 4), the difference between the groups was significant. The improvement of SF-36 and EQ-5D quality of life scores and the active range of motion was more pronounced in the balneotherapy group, the difference between the groups was not significant, except for EQ-5D at visit 2. Improvement of passive range of motion was not significant. Balneotherapy may have a beneficial effect on the clinical parameters and quality of life of patients with chronic shoulder pain. The number of patients should be increased.

Evaluation of the Efficacy, Safety, and Tolerability of BI 409306, a Novel Phosphodiesterase 9 Inhibitor, in Cognitive Impairment in Schizophrenia: A Randomized, Double-Blind, Placebo-Controlled, Phase II Trial.

PubMed

Brown, David; Nakagome, Kazuyuki; Cordes, Joachim; Brenner, Ronald; Gründer, Gerhard; Keefe, Richard S E; Riesenberg, Robert; Walling, David P; Daniels, Kristen; Wang, Lara; McGinniss, Jennifer; Sand, Michael

2018-05-01

Patients with cognitive impairment associated with schizophrenia may benefit from treatments targeting dysfunctional glutamatergic neurotransmission. BI 409306, a potent and selective phosphodiesterase 9 inhibitor, was assessed in patients with schizophrenia using a learn-and-confirm adaptive trial design. This double-blind, parallel-group trial randomized patients 2:1:1:1:1 to once-daily placebo or BI 409306 (10, 25, 50, or 100 mg) for 12 weeks. Stage 1 (learn) assessed change from baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) scores (week 12) to identify ≥1 meaningful endpoints for stage 2 (confirm). If no domains showed efficacy, change from baseline in Measurements and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) composite scores (week 12) was the primary endpoint. The key secondary endpoint was change from baseline in Schizophrenia Cognition Rating Scale (SCoRS) total score. Safety was monitored. Five hundred eighteen patients were randomized. In stage 1, CANTAB did not differentiate between BI 409306 and placebo (n = 120), so the primary endpoint of change from baseline in MCCB composite score was analyzed in 450 patients in stage 2. There was no significant difference between BI 409306 (1.2-2.8) and placebo (2.5) in MCCB composite score change. BI 409306 did not significantly improve change from baseline in SCoRS total score (-3.1 to -2.0) vs placebo (-2.5). Adverse events were dose-dependent, increasing from 33.3% (10 mg) to 53.5% (100 mg), vs 36.4% for placebo. The primary endpoint of cognitive function improvement was not met. BI 409306 was well-tolerated, with an acceptable safety profile.

Combined effects of repeated oral hygiene motivation and type of toothbrush on orthodontic patients: a blind randomized clinical trial.

PubMed

Marini, Ida; Bortolotti, Francesco; Parenti, Serena Incerti; Gatto, Maria Rosaria; Bonetti, Giulio Alessandri

2014-09-01

To investigate the effects on plaque index (PI) scores of manual or electric toothbrush with or without repeated oral hygiene instructions (OHI) and motivation on patients wearing fixed orthodontic appliances. One month after the orthodontic fixed appliance bonding on both arches, 60 patients were randomly assigned to four groups; groups E1 (n  =  15) and E2 (n  =  15) received a powered rotating-oscillating toothbrush, and groups M1 (n  =  15) and M2 (n  =  15) received a manual toothbrush. Groups E1 and M1 received OHI and motivation at baseline (T0) and after 4, 8, 12, 16, and 20 weeks (T4, T8, T12, T16, and T20, respectively) by a Registered Dental Hygienist; groups E2 and M2 received OHI and motivation only at baseline. At each time point a blinded examiner scored plaque of all teeth using the modified Quigley-Hein PI. In all groups the PI score decreased significantly over time, and there were differences among groups at T8, T12, T16, and T20. At T8, PI scores of group E1 were lower than those of group E2, and at T12, T16, and T20, PI scores of groups M1 and E1 were lower compared to those of groups M2 and E2. A linear mixed model showed that the effect of repeated OHI and motivation during time was statistically significant, independently from the use of manual or electric toothbrush. The present results showed that repeated OHI and motivation are crucial in reducing PI score in orthodontic patients, independent of the type of toothbrush used.

Option Grids to facilitate shared decision making for patients with Osteoarthritis of the knee: protocol for a single site, efficacy trial.

PubMed

Marrin, Katy; Wood, Fiona; Firth, Jill; Kinsey, Katharine; Edwards, Adrian; Brain, Kate E; Newcombe, Robert G; Nye, Alan; Pickles, Timothy; Hawthorne, Kamila; Elwyn, Glyn

2014-04-07

Despite policy interest, an ethical imperative, and evidence of the benefits of patient decision support tools, the adoption of shared decision making (SDM) in day-to-day clinical practice remains slow and is inhibited by barriers that include culture and attitudes; resources and time pressures. Patient decision support tools often require high levels of health and computer literacy. Option Grids are one-page evidence-based summaries of the available condition-specific treatment options, listing patients' frequently asked questions. They are designed to be sufficiently brief and accessible enough to support a better dialogue between patients and clinicians during routine consultations. This paper describes a study to assess whether an Option Grid for osteoarthritis of the knee (OA of the knee) facilitates SDM, and explores the use of Option Grids by patients disadvantaged by language or poor health literacy. This will be a stepped wedge exploratory trial involving 72 patients with OA of the knee referred from primary medical care to a specialist musculoskeletal service in Oldham. Six physiotherapists will sequentially join the trial and consult with six patients using usual care procedures. After a period of brief training in using the Option Grid, the same six physiotherapists will consult with six further patients using an Option Grid in the consultation. The primary outcome will be efficacy of the Option Grid in facilitating SDM as measured by observational scores using the OPTION scale. Comparisons will be made between patients who have received the Option Grid and those who received usual care. A Decision Quality Measure (DQM) will assess quality of decision making. The health literacy of patients will be measured using the REALM-R instrument. Consultations will be observed and audio-recorded. Interviews will be conducted with the physiotherapists, patients and any interpreters present to explore their views of using the Option Grid. Option Grids offer a potential solution to the barriers to implementing traditional decision aids into routine clinical practice. The study will assess whether Option Grids can facilitate SDM in day-to-day clinical practice and explore their use with patients disadvantaged by language or poor health literacy. Current Controlled Trials ISRCTN94871417.

Individual differences in fluid intelligence predicts inattentional blindness in a sample of older adults: a preliminary study.

PubMed

O'Shea, Deirdre M; Fieo, Robert A

2015-07-01

Previous research has shown that aging increases susceptibility to inattentional blindness (Graham and Burke, Psychol Aging 26:162, 2011) as well as individual differences in cognitive ability related to working memory and executive functions in separate studies. Therefore, the present study was conducted in an attempt to bridge a gap that involved investigating 'age-sensitive' cognitive abilities that may predict inattentional blindness in a sample of older adults. We investigated whether individual differences in general fluid intelligence and speed of processing would predict inattentional blindness in our sample of older adults. Thirty-six healthy older adults took part in the study. Using the inattentional blindness paradigm developed by Most et al. (Psychol Rev 112:217, 2005), we investigated whether rates of inattentional blindness could be predicted by participant's performance on the Raven's Advanced Progressive Matrices and a choice-reaction time task. A Mann-Whitney U test revealed that a higher score on the Raven's Advanced Progressive Matrices was significantly associated with lower incidences of inattentional blindness. However, a t test revealed that choice-reaction times were not significantly associated with inattentional blindness. Preliminary results from the present study suggest that individual differences in general fluid intelligence are predictive of inattentional blindness in older adults but not speed of processing. Moreover, our findings are consistent with previous studies that have suggested executive attention control may be the source of these individual differences. These findings also highlight the association between attention and general fluid intelligence and how it may impact environmental awareness. Future research would benefit from repeating these analyses in a larger sample and also including a younger comparison group.

A randomized double-blind, placebo-controlled efficacy and safety study of ALO-02 (extended-release oxycodone surrounding sequestered naltrexone) for moderate-to-severe chronic low back pain treatment.

PubMed

Rauck, Richard L; Hale, Martin E; Bass, Almasa; Bramson, Candace; Pixton, Glenn; Wilson, Jacquelyn G; Setnik, Beatrice; Meisner, Paul; Sommerville, Kenneth W; Malhotra, Bimal K; Wolfram, Gernot

2015-09-01

The objective of this multicenter, double-blind, placebo-controlled, randomized withdrawal study was to evaluate the efficacy and safety of ALO-02, an abuse-deterrent formulation containing pellets of extended-release oxycodone hydrochloride (HCl) surrounding sequestered naltrexone HCl, compared with placebo in the treatment of moderate-to-severe chronic low back pain. An open-label titration period in which all patients received ALO-02 was followed by a double-blind treatment period where patients meeting treatment response criteria were randomized to either a fixed dose of ALO-02 or placebo. Daily average low back pain was assessed using an 11-point numeric rating scale (NRS)-Pain. Of the 663 patients screened, 410 received ALO-02 during the open-label conversion and titration period and 281 patients were randomized to the double-blind treatment period (n = 134, placebo; n = 147, ALO-02). Change in the mean NRS-Pain score from randomization baseline to the final 2 weeks of the treatment period was significantly different favoring ALO-02 compared with placebo (P = 0.0114). Forty-four percent of patients treated with placebo and 57.5% of patients treated with ALO-02 reported ≥30% improvement in weekly average NRS-Pain scores from screening to the final 2 weeks of the treatment period (P = 0.0248). In the double-blind treatment period, 56.8% of patients in the ALO-02 group and 56.0% of patients in the placebo group experienced a treatment-emergent adverse event (TEAE). The most common treatment-related TEAEs for ALO-02 during the treatment period were nausea, vomiting, and constipation, consistent with opioid therapy. ALO-02 has been demonstrated to provide significant reduction of pain in patients with chronic low back pain and has a safety profile similar to other opioids.

Progression to Legal Blindness in Patients With Normal Tension Glaucoma: Hospital-Based Study.

PubMed

Sawada, Akira; Rivera, Jonathan A; Takagi, Daisuke; Nishida, Takashi; Yamamoto, Tetsuya

2015-06-01

To determine the probability of an eye with normal tension glaucoma (NTG) progressing to legal blindness under standard ophthalmic care. Patients diagnosed with NTG (n = 382) between 1985 and 2007 at Gifu University Hospital were followed for at least 5 years under standard ophthalmic care. The collected data included the best-corrected visual acuity (BCVA), intraocular pressure (IOP), and visual field status. Blindness was defined as a BCVA of <20/400 or a constriction of the central visual field to <10° according to the World Health Organization criteria. Kaplan-Meier life table analysis was used to estimate the probability of progressing to blindness in one or both eyes. The mean follow-up period after diagnosis was 13.3 ± 5.4 years with a range of 5.0 to 29.1 years. At diagnosis, 18 patients (4.7%) had unilateral blindness due to glaucoma. At final examination, 34 patients had progressed to unilateral blindness and 5 to bilateral blindness. The Kaplan-Meier life table analysis estimate for unilateral blindness was 5.8 ± 1.3% at 10 years and 9.9 ± 1.9% at 20 years. Similarly, that for bilateral blindness was 0.3 ± 0.3% at 10 years and 1.4 ± 0.8% at 20 years. A Cox proportional hazard model analysis showed that a lower initial BCVA (P < 0.001), a worse initial AGIS (Advanced Glaucoma Intervention Study) score (P = 0.002), and the frequency of changing glaucoma medications during the follow-up periods (P < 0.001) were significantly correlated with the development of blindness in at least one eye. The probability of blindness in eyes with NTG is much lower than previously reported in patients with high-tension glaucoma. Nevertheless, special care should be taken to follow NTG patients, and especially those with worse BCVA and more advanced visual field loss at diagnosis.

Executive function in adults with attention-deficit/hyperactivity disorder during treatment with atomoxetine in a randomized, placebo-controlled, withdrawal study.

PubMed

Adler, Lenard; Tanaka, Yoko; Williams, David; Trzepacz, Paula T; Goto, Taro; Allen, Albert J; Escobar, Rodrigo; Upadhyaya, Himanshu P

2014-08-01

We assessed the executive function in adults with attention-deficit/hyperactivity disorder (ADHD) during atomoxetine treatment in a randomized withdrawal trial. Responders (Conners' ADHD Rating Scale-Investigator Rated: Screening Version [adult prompts] ≥30% reduction from baseline and Clinical Global Impression Scale-ADHD Severity score ≤3) to open-label atomoxetine (40-100 mg/d, 12 weeks) entered a 37-week double-blind maintenance period. Patients who maintained response (double-blind atomoxetine for 12 weeks) were randomized 1:1 to atomoxetine (80-100 mg/d, n = 266) or placebo (n = 258) for 25 weeks (total duration, 1 year). Patients and investigators were blinded to response criteria and randomization timing. Change in executive function was assessed with the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Self-Report and Informant T scores from the randomization to the last-observation-carried-forward postrandomization week 25 (after week 17). Of the enrolled patients (n = 2017; mean age, 33.2 years; male, 58.7%), 524 responders were randomized. During open-label atomoxetine, subscales and individual items on both BRIEF-A questionnaires showed significant improvement (P < 0.001). After randomization, the following T scores improved significantly (P ≤ 0.05) with patients in the atomoxetine group versus those in the placebo group: global executive composite, behavioral regulation, and metacognition indices; plan/organize, working memory, inhibit, task monitor and shift (both BRIEF-A questionnaires), emotional control and organization of materials (BRIEF-A Informant), and initiate (BRIEF-A Self-Report). Atomoxetine significantly improved the executive function compared with placebo, which was maintained for 25 weeks or more; the executive function of patients in the placebo group worsened but did not return to baseline levels after randomization.

Interferential and horizontal therapies in chronic low back pain: a randomized, double blind, clinical study.

PubMed

Zambito, A; Bianchini, D; Gatti, D; Viapiana, O; Rossini, M; Adami, S

2006-01-01

Chronic Low Back Pain (CLBP) is one of the most frequent medical problems. Electrical nerve stimulation is frequently used but its efficacy remains controversial. Twenty-six men and 94 women with CLBP associated with either degenerative disk disease or previous multiple vertebral osteoporotic fractures were randomly assigned to either interferential currents (IFT), horizontal therapy (HT) or sham HT administered for 10, 40 and 40 minutes, respectively, daily for 5 days per week for two weeks together with a standard flexion-extension stretching exercise program, Blind efficacy assessment were obtained at baseline and at week 2, 6 and 14 and included a functional questionnaire (Backill), the standard visual analog scale (VAS) and the mean analgesic consumption. At week 2 a significant and similar improvement in both the VAS and Backill score was observed in all three groups. The Backill score continued to improve only in the two active groups with changes significantly greater than those observed in control patients at week 14. The pain VAS score returned to baseline values at week 6 and 14 in the control group while in the IFT and HT groups it continued to improve (p< 0.01 vs controls). The use of analgesic medications significantly improved at week 14 versus pretreatment assessment and over control patients only in the HT group. This randomized double-blind controlled study provides the first evidence that IFT and HT therapy are significantly effective in alleviating both pain and disability in patients with CLBP. The placebo effect is remarkable at the beginning of the treatment but it tends to vanish within a couple of weeks.

Evaluation of a Low Energy, Low Density, Non-Ablative Fractional 1927 nm Wavelength Laser for Facial Skin Resurfacing.

PubMed

Brauer, Jeremy A; Alabdulrazzaq, Hamad; Bae, Yoon-Soo Cindy; Geronemus, Roy G

2015-11-01

We investigated the safety, tolerability and efficacy of a low energy low density, non-ablative fractional 1,927-nm laser in the treatment of facial photodamage, melasma, and post inflammatory hyperpigmentation. Prospective non-randomized trial. Single center, private practice with a dedicated research department. Subjects with clinically diagnosed facial photodamage, melasma, or post inflammatory hyperpigmentation. Subjects received four to six treatments at 14-day intervals (+/- 3 days) with a low energy low density non-ablative fractional 1,927-nm laser (Solta Hayward, CA) with an energy level of 5 mJ, and density coverage of either 5%, 7.5%, or 10%, with a total of up to 8 passes. Blinded assessment of clinical photos for overall improvement at one and three months post final treatment. Investigator improvement scores, and subject pain and satisfaction scores for overall improvement were recorded as well. We enrolled 23 subjects, average age 45.0 years (range, 25-64 years), 22 with Fitzpatrick Skin Types I-IV and 1 with Type VI, with facial photodamage, melasma, or post inflammatory hyperpigmentation. Approximately 55% of subjects reported marked to very significant improvement at one and three months post final treatment. Blinded assessment of photography of 20 subjects revealed an average of moderate improvement at one-month follow up and mild to moderate improvement at three months. Average subject pain score was 3.4/10 during treatment. Favorable outcomes were demonstrated using the low energy low density, non-ablative fractional 1,927-nm laser in facial resurfacing for photodamage, melasma, and post inflammatory hyperpigmentation. Results were maintained at the 3-month follow up, as demonstrated by investigator and subject assessments, as well as blinded evaluations by three independent dermatologists utilizing photographs obtained from a standardized facial imaging device.

TSH-controlled L-thyroxine therapy reduces cholesterol levels and clinical symptoms in subclinical hypothyroidism: a double blind, placebo-controlled trial (Basel Thyroid Study).

PubMed

Meier, C; Staub, J J; Roth, C B; Guglielmetti, M; Kunz, M; Miserez, A R; Drewe, J; Huber, P; Herzog, R; Müller, B

2001-10-01

This study evaluated the effect of physiological, TSH-guided, L-thyroxine treatment on serum lipids and clinical symptoms in patients with subclinical hypothyroidism. Sixty-six women with proven subclinical hypothyroidism (TSH, 11.7 +/- 0.8 mIU/liter) were randomly assigned to receive L-thyroxine or placebo for 48 wk. Individual L-thyroxine replacement (mean dose, 85.5 +/- 4.3 microg/d) was performed based on blinded TSH monitoring, resulting in euthyroid TSH levels (3.1 +/- 0.3 mIU/liter). Lipid concentrations and clinical scores were measured before and after treatment. Sixty-three of 66 patients completed the study. In the L-thyroxine group (n = 31) total cholesterol and low density lipoprotein cholesterol were significantly reduced [-0.24 mmol/liter, 3.8% (P = 0.015) and -0.33 mmol/liter, 8.2% (P = 0.004), respectively]. Low density lipoprotein cholesterol decrease was more pronounced in patients with TSH levels greater than 12 mIU/liter or elevated low density lipoprotein cholesterol levels at baseline. A significant decrease in apolipoprotein B-100 concentrations was observed (P = 0.037), whereas high density lipoprotein cholesterol, triglycerides, apolipoprotein AI, and lipoprotein(a) levels remained unchanged. Two clinical scores assessing symptoms and signs of hypothyroidism (Billewicz and Zulewski scores) improved significantly (P = 0.02). This is the first double blind study to show that physiological L-thyroxine replacement in patients with subclinical hypothyroidism has a beneficial effect on low density lipoprotein cholesterol levels and clinical symptoms of hypothyroidism. An important risk reduction of cardiovascular mortality of 9-31% can be estimated from the observed improvement in low density lipoprotein cholesterol.

Oxytocin efficacy is modulated by dosage and oxytocin receptor genotype in young adults with high-functioning autism: a 24-week randomized clinical trial

PubMed Central

Kosaka, H; Okamoto, Y; Munesue, T; Yamasue, H; Inohara, K; Fujioka, T; Anme, T; Orisaka, M; Ishitobi, M; Jung, M; Fujisawa, T X; Tanaka, S; Arai, S; Asano, M; Saito, D N; Sadato, N; Tomoda, A; Omori, M; Sato, M; Okazawa, H; Higashida, H; Wada, Y

2016-01-01

Recent studies have suggested that long-term oxytocin administration can alleviate the symptoms of autism spectrum disorder (ASD); however, factors influencing its efficacy are still unclear. We conducted a single-center phase 2, pilot, randomized, double-blind, placebo-controlled, parallel-group, clinical trial in young adults with high-functioning ASD, to determine whether oxytocin dosage and genetic background of the oxytocin receptor affects oxytocin efficacy. This trial consisted of double-blind (12 weeks), open-label (12 weeks) and follow-up phases (8 weeks). To examine dose dependency, 60 participants were randomly assigned to high-dose (32 IU per day) or low-dose intranasal oxytocin (16 IU per day), or placebo groups during the double-blind phase. Next, we measured single-nucleotide polymorphisms (SNPs) in the oxytocin receptor gene (OXTR). In the intention-to-treat population, no outcomes were improved after oxytocin administration. However, in male participants, Clinical Global Impression-Improvement (CGI-I) scores in the high-dose group, but not the low-dose group, were significantly higher than in the placebo group. Furthermore, we examined whether oxytocin efficacy, reflected in the CGI-I scores, is influenced by estimated daily dosage and OXTR polymorphisms in male participants. We found that >21 IU per day oxytocin was more effective than ⩽21 IU per day, and that a SNP in OXTR (rs6791619) predicted CGI-I scores for ⩽21 IU per day oxytocin treatment. No severe adverse events occurred. These results suggest that efficacy of long-term oxytocin administration in young men with high-functioning ASD depends on the oxytocin dosage and genetic background of the oxytocin receptor, which contributes to the effectiveness of oxytocin treatment of ASD. PMID:27552585

Oxytocin efficacy is modulated by dosage and oxytocin receptor genotype in young adults with high-functioning autism: a 24-week randomized clinical trial.

PubMed

Kosaka, H; Okamoto, Y; Munesue, T; Yamasue, H; Inohara, K; Fujioka, T; Anme, T; Orisaka, M; Ishitobi, M; Jung, M; Fujisawa, T X; Tanaka, S; Arai, S; Asano, M; Saito, D N; Sadato, N; Tomoda, A; Omori, M; Sato, M; Okazawa, H; Higashida, H; Wada, Y

2016-08-23

Recent studies have suggested that long-term oxytocin administration can alleviate the symptoms of autism spectrum disorder (ASD); however, factors influencing its efficacy are still unclear. We conducted a single-center phase 2, pilot, randomized, double-blind, placebo-controlled, parallel-group, clinical trial in young adults with high-functioning ASD, to determine whether oxytocin dosage and genetic background of the oxytocin receptor affects oxytocin efficacy. This trial consisted of double-blind (12 weeks), open-label (12 weeks) and follow-up phases (8 weeks). To examine dose dependency, 60 participants were randomly assigned to high-dose (32 IU per day) or low-dose intranasal oxytocin (16 IU per day), or placebo groups during the double-blind phase. Next, we measured single-nucleotide polymorphisms (SNPs) in the oxytocin receptor gene (OXTR). In the intention-to-treat population, no outcomes were improved after oxytocin administration. However, in male participants, Clinical Global Impression-Improvement (CGI-I) scores in the high-dose group, but not the low-dose group, were significantly higher than in the placebo group. Furthermore, we examined whether oxytocin efficacy, reflected in the CGI-I scores, is influenced by estimated daily dosage and OXTR polymorphisms in male participants. We found that >21 IU per day oxytocin was more effective than ⩽21 IU per day, and that a SNP in OXTR (rs6791619) predicted CGI-I scores for ⩽21 IU per day oxytocin treatment. No severe adverse events occurred. These results suggest that efficacy of long-term oxytocin administration in young men with high-functioning ASD depends on the oxytocin dosage and genetic background of the oxytocin receptor, which contributes to the effectiveness of oxytocin treatment of ASD.

Ultrasound-guided transversus abdominis plane block for postoperative analgesia in living liver donors: A prospective, randomized, double-blinded clinical trial.

PubMed

Kıtlık, Arzu; Erdogan, Mehmet Ali; Ozgul, Ulku; Aydogan, Mustafa Said; Ucar, Muharrem; Toprak, Huseyin Ilksen; Colak, Cemil; Durmus, Mahmut

2017-02-01

Transversus abdominis plane (TAP) block is a peripheral nerve block that reduces postoperative pain, nausea, vomiting and the need for postoperative opioids following various types of abdominal surgery. The primary aim of the present study was to evaluate the effects of TAP block on postoperative analgesia and opioid consumption in living liver donors in whom a right "J" abdominal incision was used. This prospective, double-blinded, randomized controlled study was conducted with 50 living liver donors, aged 18-65years, who were scheduled to undergo right hepatectomy. Patients who received ultrasonography-guided subcostal TAP block were allocated into Group 1, and patients who did not receive TAP block were allocated into Group 2. The TAP blocks were performed bilaterally at the conclusion of surgery using 1.5mg∗kg -1 bupivacaine diluted with saline to reach a total volume of 40mL. For each patient, morphine consumption, pain scores at rest and movement, sedation scores, nausea, vomiting and the need for antiemetic medication were assessed at 0, 2, 4, 6, 12 and 24h postoperatively by researchers who were blinded to the study groups. Morphine consumption was significantly lower in Group 1 than in Group 2 at the 2nd, 6th and 24th hours (P<0.05). The mean total morphine consumption values after 24h were 40mg and 65mg in Groups 1 and 2, respectively. The TAP block significantly reduced postoperative visual analog scale pain scores both at rest and during movement at 0, 2, 4, 6, and 24h postoperatively (P<0.05). The TAP block reduced 24-h postoperative morphine consumption and contributed to analgesia in living liver donors who underwent upper abdominal wall incisions. Copyright © 2016 Elsevier Inc. All rights reserved.

Efficacy and Safety of Amphetamine Extended-Release Oral Suspension in Children with Attention-Deficit/Hyperactivity Disorder.

PubMed

Childress, Ann C; Wigal, Sharon B; Brams, Matthew N; Turnbow, John M; Pincus, Yulia; Belden, Heidi W; Berry, Sally A

2018-06-01

To determine the efficacy and safety of amphetamine extended-release oral suspension (AMPH EROS) in the treatment of attention-deficit/hyperactivity disorder (ADHD) in a dose-optimized, randomized, double-blind, parallel-group study. Boys and girls aged 6 to 12 years diagnosed with ADHD were enrolled. During a 5-week, open-label, dose-optimization phase, patients began treatment with 2.5 or 5 mg/day of AMPH EROS; doses were titrated until an optimal dose (maximum 20 mg/day) was reached. During the double-blind phase, patients were randomized to receive treatment with either their optimized dose (10-20 mg/day) of AMPH EROS or placebo for 1 week. Efficacy was assessed in a laboratory classroom setting on the final day of double-blind treatment using the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale and Permanent Product Measure of Performance (PERMP) test. Safety was assessed measuring adverse events (AEs) and vital signs. The study was completed by 99 patients. The primary efficacy endpoint (change from predose SKAMP-Combined score at 4 hours postdose) and secondary endpoints (change from predose SKAMP-Combined scores at 1, 2, 6, 8, 10, 12, and 13 hours postdose) were statistically significantly improved with AMPH EROS treatment versus placebo at all time points. Onset of treatment effect was present by 1 hour postdosing, the first time point measured, and duration of efficacy lasted 13 hours postdosing. PERMP data mirrored the SKAMP-Combined score data. AEs (>5%) reported during dose optimization were decreased appetite, insomnia, affect lability, upper abdominal pain, mood swings, and headache. AMPH EROS was effective in reducing symptoms of ADHD and had a rapid onset and extended duration of effect. Reported AEs were consistent with those of other extended-release amphetamine products.

A randomized controlled trial of a middle meatal silastic stent for reducing adhesions and middle turbinate lateralization following endoscopic sinus surgery.

PubMed

Chan, Chun L; Elmiyeh, Behrad; Woods, Charmaine; Ullah, Shahid; Gunawardena, Indunil; Carney, A Simon; Ooi, Eng H

2015-06-01

Endoscopic sinus surgery (ESS) is indicated for patients with recalcitrant chronic rhinosinusitis symptoms. However, surgical revision can be required because of adhesion formation and middle turbinate lateralization. We investigate the efficacy of a middle meatal silastic stent in reducing these complications after ESS. Thirty-six patients were randomized to receive a silastic stent in the middle meatus unilaterally after ESS. The surgeon was blinded to the side receiving the stent until completion of the ESS. The contralateral side, with no stent, was the control side. Patients completed a 7-day, postoperative, visual analog scale symptom diary and were blinded to the stent side until its removal at the first postoperative visit. Patients were followed up after 2, 8, and 24 weeks. Endoscopic video of the sinus cavities were recorded at all visits and 2 blinded, independent ear/nose/throat (ENT) surgeons assessed the videos using a modified Lund-Kennedy scoring system. Thirty-five of 36 patients completed 6-months' follow-up. Middle turbinate lateralization was observed in 13 sides without a stent vs 1 side with a stent. There was a significant reduction in adhesions at weeks 2 and 8 (p < 0.001) and crusting (p < 0.01) in the stent side compared to control. Video scores at 6 months after surgery for stent and control sides remained unchanged from the 8-week visit. There was no difference between sides for symptom scores, edema, or nasal discharge. Middle meatal silastic stents are well tolerated by patients and effective in reducing middle turbinate lateralization, adhesions, and crusting postoperatively in ESS. © 2015 ARS-AAOA, LLC.

MR Enterography of the Ileoanal Pouch: Descriptive Radiologic Analysis With Endoscopic and Pathologic Correlation.

PubMed

Sahi, Kamaldeep Singh; Lee, Karen S; Moss, Alan; Yee, Eric; Allard, Felicia; Brook, Alexander; Mortele, Koenraad J

2015-11-01

The purpose of this study was to describe the MR enterography (MRE) appearance of inflammation of the ileoanal pouch after ileal pouch-anal anastomosis (IPAA) surgery and to correlate it with pouch endoscopic and histopathologic findings. All MRE studies performed between October 1, 2007, and September 30, 2013, for patients who had previously undergone IPAA (n = 54) were retrieved. After review of medical records, the patients who underwent MRE, pouch endoscopy, and biopsy within 90 days (14 men, 14 women; mean age, 42.2 years; range, 24-67 years) were selected for inclusion in the study. Two blinded MRI radiologists in consensus retrospectively evaluated MRE studies for multiple MRI features. Two MRI scores were then calculated: an active and a composite inflammation score. A gastroenterologist retrospectively reviewed the pouch endoscopic images, and a pathologist reviewed the slides; both of these investigators were blinded. Both MRI scores were correlated with the pouch endoscopic and histopathologic findings. The composite MRI score had strong positive correlation with the endoscopic score (r = 0.61; p = 0.0005) but weak positive correlation with the histopathologic score (r = 0.31; p = 0.10, not statistically significant). The active inflammation MRI score had moderate positive correlation with the endoscopic score (r = 0.57; p = 0.0017) and weak positive correlation with the histopathologic score (r = 0.20; p = 0.31, not statistically significant). An MRI score ≥ 4 indicated the best results, with sensitivity of 86%, specificity of 79%, positive predictive value of 80%, negative predictive value of 85%, and accuracy of 82% for pouch inflammation. A positive likelihood ratio of 4.00 and negative likelihood ratio of 0.18 were obtained. In patients who have undergone IPAA surgery, the MRE findings strongly correlate with the pouch endoscopic findings with high sensitivity and positive predictive value for pouch inflammation. Therefore, MRE is a useful noninvasive test performed without ionizing radiation that can be used to evaluate patients with clinical symptoms and possibly alleviate the need for endoscopy in a select patient population.

Effects of pimecrolimus cream 1% in the treatment of patients with atopic dermatitis who demonstrate a clinical insensitivity to topical corticosteroids: a randomized, multicentre vehicle-controlled trial.

PubMed

Leung, D Y M; Hanifin, J M; Pariser, D M; Barber, K A; Langley, R G; Schlievert, P M; Abrams, B; Hultsch, T

2009-08-01

Colonization with Staphylococcus aureus in atopic dermatitis (AD) is often associated with worsening of clinical symptoms. Staphylococcus aureus produces superantigens that contribute to cutaneous inflammation and corticosteroid (CS) resistance. To investigate the relationship between CS insensitivity, S. aureus colonization and superantigen production in AD, and to explore the efficacy of pimecrolimus cream in CS-insensitive AD. This was a randomized, double-blind, vehicle-controlled, multicentre, parallel-group study. Seventy-three patients with AD, aged 2-49 years, who had a documented clinical insensitivity to topical CS, were recruited. The primary efficacy parameters combined laboratory (including S. aureus colonization, superantigens) and clinical assessments [including Eczema Area and Severity Index (EASI), whole body Investigator's Global Assessment (IGA), pruritus assessment score, patient's assessment score of disease control]. An increase in S. aureus counts correlated with worsening of clinical score (week 6 vs. baseline) when assessed by IGA, pruritus severity and patient assessment. The presence of superantigens correlated with this worsening. During the 6-week double-blind phase, disease improvement in the pimecrolimus cream group was demonstrated by decreasing EASI scores compared with vehicle. Mean EASI scores for the head and neck showed greater improvement in the pimecrolimus cream group than in the vehicle group at all observed time points. In a cohort of patients with clinical insensitivity to CS there was a significant positive correlation between S. aureus and disease severity. Results suggest that for some of these patients, treatment with pimecrolimus cream 1% is useful, especially in the head/neck area.

Risperidone in children with autism: randomized, placebo-controlled, double-blind study.

PubMed

Nagaraj, Ravishankar; Singhi, Pratibha; Malhi, Prahbhjot

2006-06-01

Some open-label studies suggest that risperidone can be useful in the treatment of certain target symptoms in children with autism. We aimed to study whether the use of risperidone in comparison with placebo improved functioning in children with autism with regard to behavior (aggressiveness, hyperactivity, irritability), social and emotional responsiveness, and communication skills. We conducted a randomized, double-blind, placebo-controlled trial with 40 consecutive children with autism, whose ages ranged from 2 to 9 years, who were receiving either risperidone or placebo given orally at a dose of 1 mg/day for 6 months. Autism symptoms were monitored periodically. The outcome variables were total scores on the Childhood Autism Rating Scale (CARS) and the Children's Global Assessment Scale (CGAS) after 6 months. Of the 40 children enrolled, 39 completed the trial over a period of 18 months; 19 received risperidone, and 20 received placebo. In the risperidone group, 12 of 19 children showed improvement in the total Childhood Autism Rating Scale score and 17 of 19 children in the Children's Global Assessment Scale score compared with 0 of 20 children for the Childhood Autism Rating Scale score and 2 of 20 children for the Children's Global Assessment Scale score in the placebo group (P < .001 and P = .035, respectively). Risperidone also improved social responsiveness and nonverbal communication and reduced the symptoms of hyperactivity and aggression. Risperidone was associated with increased appetite and a mild weight gain, mild sedation in 20%, and transient dyskinesias in three children. Risperidone improved global functioning and social responsiveness while reducing hyperactivity and aggression in children with autism and was well tolerated.

Assessment of abuse liability of Tramadol among experienced drug users: Double-blind crossover randomized controlled trial.

PubMed

Das, Mrinmay; Jain, Raka; Dhawan, Anju; Kaur, Amandeep

Tramadol is a widely used opioid analgesic. Different preclinical, clinical, and postmarketing surveillance studies show conflicting results regarding abuse potential of this drug. A randomized double-blind complete crossover study was conducted at National Drug Dependence Treatment Centre, All India Institute of Medical Sciences, New Delhi. Total subjects were 10, comprising total 120 observations (each subject assessed at baseline, 5, 45, and 240 minutes). Subjects with history of substance abuse were included after detoxification and informed consent. Assessment was done using modified single dose opiate questionnaire, morphine benzedrine group (MBG), pentobarbital chlorpromazine alcohol group (PCAG), and two bipolar visual analogue scales (VAS) after administration of three drugs-Tramadol (100 mg), Buprenorphine (0.6 mg), and Placebo (Normal Saline) intramuscularly, at 5-day interval. In intra-group analysis, there was statistically significant increase in scores of all four scales from baseline to all three time points after Tramadol and Buprenorphine administration. In inter-group analysis, statistically higher scores were seen for Buprenorphine in comparison to Tramadol at 5, 45, and 240 minutes for MBG scale; the score was significantly higher for Buprenorphine in VAS for pleasurable effect at 45 and 240 minutes, but not at baseline and 5 minutes. There was no significant difference in score at any point of time between Tramadol and Buprenorphine in PCAG scale and VAS for sedative/alertness effect. The scores were statistically insignificant in case of Placebo. All the subjects liked Buprenorphine most and then Tramadol followed by Placebo. Tramadol has abuse potential (even in therapeutic doses) more than Placebo but less than or comparable to Buprenorphine.

Hippocampal MR volumetry

NASA Astrophysics Data System (ADS)

Haller, John W.; Botteron, K.; Brunsden, Barry S.; Sheline, Yvette I.; Walkup, Ronald K.; Black, Kevin J.; Gado, Mokhtar; Vannier, Michael W.

1994-09-01

Goal: To estimate hippocampal volumes from in vivo 3D magnetic resonance (MR) brain images and determine inter-rater and intra- rater repeatability. Objective: The precision and repeatability of hippocampal volume estimates using stereologic measurement methods is sought. Design: Five normal control and five schizophrenic subjects were MR scanned using a MPRAGE protocol. Fixed grid stereologic methods were used to estimate hippocampal volumes on a graphics workstation. The images were preprocessed using histogram analysis to standardize 3D MR image scaling from 16 to 8 bits and image volumes were interpolated to 0.5 mm3 isotropic voxels. The following variables were constant for the repeated stereologic measures: grid size, inter-slice distance (1.5 mm), voxel dimensions (0.5 mm3), number of hippocampi measured (10), total number of measurements per rater (40), and number of raters (5). Two grid sizes were tested to determine the coefficient of error associated with the number of sampled 'hits' (approximately 140 and 280) on the hippocampus. Starting slice and grid position were randomly varied to assure unbiased volume estimates. Raters were blind to subject identity, diagnosis, and side of the brain from which the image volumes were extracted and the order of subject presentation was randomized for each of the raters. Inter- and intra-rater intraclass correlation coefficients (ICC) were determined. Results: The data indicate excellent repeatability of fixed grid stereologic hippocampal volume measures when using an inter-slice distance of 1.5 mm and a 6.25 mm2 grid (inter-rater ICCs equals 0.86 - 0.97, intra- rater ICCs equals 0.85 - 0.97). One major advantage of the current study was the use of 3D MR data which significantly improved visualization of hippocampal boundaries by providing the ability to access simultaneous orthogonal views while counting stereological marks within the hippocampus. Conclusion: Stereological estimates of 3D volumes from 2D MR sections provide an inexpensive, unbiased and efficient way of determining brain structural volumes. The high precision and repeatability demonstrated with stereological MR volumetry suggest that these methods may be efficiently used to measure small volume reductions associated with schizophrenia and other brain disorders.

A study of some psycho-social characteristics of blind and deaf male students in Abha City, Asir region, Saudi Arabia.

PubMed

Abolfotouh, M A; Telmesani, A

1993-07-01

Psychosocial characteristics including depression, attitude towards their handicap, hobbies and problems of living situations have been studied among 152 male students in the Institute for the Blind (n = 44) and in the Institute for the Deaf (n = 108) in Abha City. All students were subjected to a constructed Arabic version of the rating scale 'Children Depression Inventory (CDI)'. They were categorised according to their scores on this CDI, into depressed and non-depressed. Also, an interview questionnaire was administered to collect data related to the handicap, such as age of onset, and its cause and family history of the same handicap. The effect of the handicap upon the attitudes of students in relation to their social tendencies, hobbies and problems in living situations was studied. The mean ages for blind and deaf students were 15.70 and 13.04 years respectively. About 91.% and 75.% of blind and deaf students respectively were born with their handicap. Depression was more prevalent among the blind (14%) than among the deaf (6.5%) students. Difficulty in mobility was the main problem among blind students (44%) while difficulty in communication with people was the main problem among the deaf (52%). Reading was the commonest hobby for the blind (51%), while playing football was the commonest among the deaf (62%). This information should be considered when planning for rehabilitative services for these groups.

Three-dimensional fusion of spaceborne and ground radar reflectivity data using a neural network-based approach

NASA Astrophysics Data System (ADS)

Kou, Leilei; Wang, Zhuihui; Xu, Fen

2018-03-01

The spaceborne precipitation radar onboard the Tropical Rainfall Measuring Mission satellite (TRMM PR) can provide good measurement of the vertical structure of reflectivity, while ground radar (GR) has a relatively high horizontal resolution and greater sensitivity. Fusion of TRMM PR and GR reflectivity data may maximize the advantages from both instruments. In this paper, TRMM PR and GR reflectivity data are fused using a neural network (NN)-based approach. The main steps included are: quality control of TRMM PR and GR reflectivity data; spatiotemporal matchup; GR calibration bias correction; conversion of TRMM PR data from Ku to S band; fusion of TRMM PR and GR reflectivity data with an NN method; interpolation of reflectivity data that are below PR's sensitivity; blind areas compensation with a distance weighting-based merging approach; combination of three types of data: data with the NN method, data below PR's sensitivity and data within compensated blind areas. During the NN fusion step, the TRMM PR data are taken as targets of the training NNs, and gridded GR data after horizontal downsampling at different heights are used as the input. The trained NNs are then used to obtain 3D high-resolution reflectivity from the original GR gridded data. After 3D fusion of the TRMM PR and GR reflectivity data, a more complete and finer-scale 3D radar reflectivity dataset incorporating characteristics from both the TRMM PR and GR observations can be obtained. The fused reflectivity data are evaluated based on a convective precipitation event through comparison with the high resolution TRMM PR and GR data with an interpolation algorithm.

Analgesic effects in dogs of carprofen and pethidine together compared with the effects of either drug alone.

PubMed

Slingsby, L S; Waterman-Pearson, A E

2001-04-07

Thirty bitches undergoing routine neutering were used in an assessor-blinded trial of the postoperative analgesic effects of pethidine and carprofen administered either together or singly. The level of analgesia was assessed by visual analogue scale (VAS) scores for pain and sedation and by nociceptive mechanical threshold testing. The two drugs administered together, and carprofen alone, provided good postoperative analgesia as assessed by VAS scoring. Pethidine alone did not provide postoperative analgesia of sufficient duration.

Magnetic resonance imaging-ultrasound fusion biopsy for prediction of final prostate pathology.

PubMed

Le, Jesse D; Stephenson, Samuel; Brugger, Michelle; Lu, David Y; Lieu, Patricia; Sonn, Geoffrey A; Natarajan, Shyam; Dorey, Frederick J; Huang, Jiaoti; Margolis, Daniel J A; Reiter, Robert E; Marks, Leonard S

2014-11-01

We explored the impact of magnetic resonance imaging-ultrasound fusion prostate biopsy on the prediction of final surgical pathology. A total of 54 consecutive men undergoing radical prostatectomy at UCLA after fusion biopsy were included in this prospective, institutional review board approved pilot study. Using magnetic resonance imaging-ultrasound fusion, tissue was obtained from a 12-point systematic grid (mapping biopsy) and from regions of interest detected by multiparametric magnetic resonance imaging (targeted biopsy). A single radiologist read all magnetic resonance imaging, and a single pathologist independently rereviewed all biopsy and whole mount pathology, blinded to prior interpretation and matched specimen. Gleason score concordance between biopsy and prostatectomy was the primary end point. Mean patient age was 62 years and median prostate specific antigen was 6.2 ng/ml. Final Gleason score at prostatectomy was 6 (13%), 7 (70%) and 8-9 (17%). A tertiary pattern was detected in 17 (31%) men. Of 45 high suspicion (image grade 4-5) magnetic resonance imaging targets 32 (71%) contained prostate cancer. The per core cancer detection rate was 20% by systematic mapping biopsy and 42% by targeted biopsy. The highest Gleason pattern at prostatectomy was detected by systematic mapping biopsy in 54%, targeted biopsy in 54% and a combination in 81% of cases. Overall 17% of cases were upgraded from fusion biopsy to final pathology and 1 (2%) was downgraded. The combination of targeted biopsy and systematic mapping biopsy was needed to obtain the best predictive accuracy. In this pilot study magnetic resonance imaging-ultrasound fusion biopsy allowed for the prediction of final prostate pathology with greater accuracy than that reported previously using conventional methods (81% vs 40% to 65%). If confirmed, these results will have important clinical implications. Copyright © 2014 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Quality of qualitative studies centred on patients in family practice: a systematic review.

PubMed

Cambon, Benoit; Vorilhon, Philippe; Michel, Laurence; Cadwallader, Jean-Sébastien; Aubin-Auger, Isabelle; Pereira, Bruno; Vaillant Roussel, Hélène

2016-12-01

Qualitative research is often used in the field of general medicine. Our objective was to evaluate the quality of published qualitative studies conducted using individual interviews or focus groups centred on patients monitored in general practice. We have undertaken a review of the literature in the PubMed and Embase databases of articles up to February 2014. The selection criteria were qualitative studies conducted using individual interviews or focus groups, centred on patients monitored in general practice. The articles chosen were analysed and evaluated using a score established from the Relevance, Appropriateness, Transparency and Soundness (RATS) grid. The average score of the 52 studies chosen was 28 out of 42. The criteria least often present were the description of the patients who chose not to participate in the study, the justification of the end of data collection, the discussion of the influence of the researchers and the discussion of the confidentiality of the data. The criteria most frequently described were an explicit research question, justified and in relation to existing knowledge, the agreement of the ethical committee and the presence of quotations. The number of studies and the score increased from year-to-year. The score was independent of the impact factor of the journal. Even though the qualitative research was published in reviews with a low impact factor, our results suggest that this research responded to the quality criteria of the RATS grid. The evaluation scored using RATS could be useful for authors or reviewers and for literature reviews. © The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Pilot Study of Droxidopa With Carbidopa in Adults With ADHD.

PubMed

Adler, Lenard A; Gorny, Stephen W

2015-04-23

We conducted a two-period (open-label and double-blind) pilot investigation of droxidopa, with and without carbidopa, for ADHD. Twenty adult ADHD patients received open-label droxidopa titrated from 200 to 600 mg 3 times per day (TID; Weeks 1-3), then open-label droxidopa plus carbidopa titrated from 25 or 50 mg TID (Weeks 4-6). In Weeks 7 to 8, patients were randomized to continued co-treatment or matching placebo substitution. Improvements in mean total Adult ADHD Investigator Symptom Report Scale (AISRS) scores were seen at Week 1 (p < .0001) and Week 3 (p < .0001). Improvements were maintained but not increased with carbidopa. Thirteen of 20 patients completed open-label treatment. In the double-blind period, mean total AISRS scores were similar between the co-treatment (n = 6) and placebo (n = 5) groups. No serious adverse events were reported. These preliminary findings indicate that droxidopa can improve adult ADHD symptoms. Further studies are warranted to examine the efficacy and safety of droxidopa in ADHD. © 2015 SAGE Publications.

A prospective single-blind randomized-controlled trial comparing two surgical techniques for the treatment of snoring: laser palatoplasty versus uvulectomy with punctate palatal diathermy.

PubMed

Uppal, S; Nadig, S; Jones, C; Nicolaides, A R; Coatesworth, A P

2004-06-01

The aim of this study was to compare laser palatoplasty with uvulectomy with punctate palatal diathermy as treatment modalities for snoring. The study design was a prospective, single-blind, randomized-controlled trial. Eighty-three patients entered the trial. After a mean follow-up period of more than 18 months there was no statistically significant difference between the two groups regarding the patient perception of benefit from surgery or the subjective improvement in snoring. However, there was a statistically significant difference in the degree of pain in the immediate postoperative period (mean difference = 22.14, 95% CI = 7.98-36.31, P = 0.003), with the pain being worse in the laser palatoplasty group. Relative risk of complications for laser palatoplasty was 1.42 (95% CI = 0.93-2.17). The snoring scores and Glasgow Benefit Inventory scores decreased with time in both the groups but there was no statistically significant difference between the two groups.

Blind image quality assessment based on aesthetic and statistical quality-aware features

NASA Astrophysics Data System (ADS)

Jenadeleh, Mohsen; Masaeli, Mohammad Masood; Moghaddam, Mohsen Ebrahimi

2017-07-01

The main goal of image quality assessment (IQA) methods is the emulation of human perceptual image quality judgments. Therefore, the correlation between objective scores of these methods with human perceptual scores is considered as their performance metric. Human judgment of the image quality implicitly includes many factors when assessing perceptual image qualities such as aesthetics, semantics, context, and various types of visual distortions. The main idea of this paper is to use a host of features that are commonly employed in image aesthetics assessment in order to improve blind image quality assessment (BIQA) methods accuracy. We propose an approach that enriches the features of BIQA methods by integrating a host of aesthetics image features with the features of natural image statistics derived from multiple domains. The proposed features have been used for augmenting five different state-of-the-art BIQA methods, which use statistical natural scene statistics features. Experiments were performed on seven benchmark image quality databases. The experimental results showed significant improvement of the accuracy of the methods.

Effectiveness of hyaluronic acid in post-tonsillectomy pain relief and wound healing: a prospective, double-blind, controlled clinical study.

PubMed

Hancı, Deniz; Altun, Huseyin

2015-09-01

To find the effectiveness of hyaluronic acid in post-tonsillectomy pain relief and wound healing. Fifty patients were included in this prospective, double-blind, controlled clinical study (20 males, 30 females mean age of 13.56 years). Hyaluronic acid was applied to one side and the other side was used as a control during tonsillectomy. Therefore, the same patient evaluated and scored the post-tonsillectomy pain, excluding individual bias. Results indicated that patients had significantly lower pain scores for hyaluronic acid treated side (p<0.001). At the end of two weeks follow-up period, the wound in the hyaluronic acid side was almost completely healed, indicating that the healing was faster with hyaluronic acid compared to control side (p<0.001). Hyaluronic acid could be recommended as an effective treatment for the management of post-tonsillectomy pain and wound healing. Copyright © 2015. Published by Elsevier Ireland Ltd.

Efficacy of Intravenous Acetaminophen in Periimplantation Pain of Cardiac Electronic Devices: A Randomized Double-Blinded Study.

PubMed

Mollazadeh, Reza; Eftekhari, Mohammad Reza; Eslami, Masoud

2017-06-01

Although intravenous acetaminophen has been administered to reduce postoperative pain, it has not been used during cardiac implantable electronic devices (CIEDs) implantation. This was a randomized double-blinded interventional study. Thirty-two patients who were referred for new CIED implantation during July 2012 until April 2013 randomly received placebo or 1 g of intravenous acetaminophen. All patients were treated with local anesthesia. Pain score during incision, pocket creation, and in the recovery room, and the patients' need for analgesics during the 6 hours after the procedure were recorded in both groups. Seventeen and 15 patients received acetaminophen and placebo, respectively. Pain scores in patients treated with acetaminophen were significantly lower (4.4 vs 2.9, P = .004), and they received less analgesics (17% vs 60%, P = .014). Intravenous administration of acetaminophen is effective for pain relief in patients undergoing CIED implantation and decreases the need for postoperative analgesics. Copyright © 2016 American Society of PeriAnesthesia Nurses. Published by Elsevier Inc. All rights reserved.

Lactobacillus salivarius WB21--containing tablets for the treatment of oral malodor: a double-blind, randomized, placebo-controlled crossover trial.

PubMed

Suzuki, Nao; Yoneda, Masahiro; Tanabe, Kazunari; Fujimoto, Akie; Iha, Kosaku; Seno, Kei; Yamada, Kazuhiko; Iwamoto, Tomoyuki; Masuo, Yosuke; Hirofuji, Takao

2014-04-01

This study evaluated the effect of probiotic intervention using lactobacilli on oral malodor. We conducted a 14-day, double-blind, placebo-controlled, randomized crossover trial of tablets containing Lactobacillus salivarius WB21 (2.0 × 10(9) colony-forming units per day) or placebo taken orally by patients with oral malodor. Organoleptic test scores significantly decreased in both the probiotic and placebo periods compared with the respective baseline scores (P < .001 and P = .002), and no difference was detected between periods. In contrast, the concentration of volatile sulfur compounds (VSCs) (P = .019) and the average probing pocket depth (P = .001) decreased significantly in the probiotic period compared with the placebo period. Bacterial quantitative analysis found significantly lower levels of ubiquitous bacteria (P = .003) and Fusobacterium nucleatum (P = .020) in the probiotic period. These results indicated that daily oral consumption of tablets containing probiotic lactobacilli could help to control oral malodor and malodor-related factors. Copyright © 2014 Elsevier Inc. All rights reserved.

A Selective Nociceptin Receptor Antagonist to Treat Depression: Evidence from Preclinical and Clinical Studies.

PubMed

Post, Anke; Smart, Trevor S; Krikke-Workel, Judith; Dawson, Gerard R; Harmer, Catherine J; Browning, Michael; Jackson, Kimberley; Kakar, Rishi; Mohs, Richard; Statnick, Michael; Wafford, Keith; McCarthy, Andrew; Barth, Vanessa; Witkin, Jeffrey M

2016-06-01

Nociceptin/Orphanin FQ (N/OFQ) is an endogenous ligand of the N/OFQ peptide (NOP) receptor, which is a G protein-coupled receptor in brain regions associated with mood disorders. We used a novel, potent, and selective orally bioavailable antagonist, LY2940094, to test the hypothesis that blockade of NOP receptors would induce antidepressant effects. In this study we demonstrate that targeting NOP receptors with LY2940094 translates to antidepressant-like effects in rodent models and, importantly, to antidepressant efficacy in patients with major depressive disorder (MDD). The proof-of-concept study (POC) was an 8-week, double-blind, placebo-controlled trial that evaluated LY2940094 as a novel oral medication for the treatment of patients with MDD. Once daily oral dosing of LY2940094 at 40 mg for 8 weeks vs placebo provided some evidence for an antidepressant effect based on the change from baseline to week 8 in the GRID-Hamilton Depression Rating Scale-17 item total score, although the predefined POC efficacy criterion (probability of LY2940094 being better than placebo⩾88%) was not met (82.9%). LY2940094 also had an early effect on the processing of emotional stimuli at Week 1 as shown by an increased recognition of positive relative to negative facial expressions in an emotional test battery. LY2940094 was safe and well tolerated. Overall, these are the first human data providing evidence that the blockade of NOP receptor signaling represents a promising strategy for the treatment of MDD.

A Selective Nociceptin Receptor Antagonist to Treat Depression: Evidence from Preclinical and Clinical Studies

PubMed Central

Post, Anke; Smart, Trevor S; Krikke-Workel, Judith; Dawson, Gerard R; Harmer, Catherine J; Browning, Michael; Jackson, Kimberley; Kakar, Rishi; Mohs, Richard; Statnick, Michael; Wafford, Keith; McCarthy, Andrew; Barth, Vanessa; Witkin, Jeffrey M

2016-01-01

Nociceptin/Orphanin FQ (N/OFQ) is an endogenous ligand of the N/OFQ peptide (NOP) receptor, which is a G protein-coupled receptor in brain regions associated with mood disorders. We used a novel, potent, and selective orally bioavailable antagonist, LY2940094, to test the hypothesis that blockade of NOP receptors would induce antidepressant effects. In this study we demonstrate that targeting NOP receptors with LY2940094 translates to antidepressant-like effects in rodent models and, importantly, to antidepressant efficacy in patients with major depressive disorder (MDD). The proof-of-concept study (POC) was an 8-week, double-blind, placebo-controlled trial that evaluated LY2940094 as a novel oral medication for the treatment of patients with MDD. Once daily oral dosing of LY2940094 at 40 mg for 8 weeks vs placebo provided some evidence for an antidepressant effect based on the change from baseline to week 8 in the GRID-Hamilton Depression Rating Scale-17 item total score, although the predefined POC efficacy criterion (probability of LY2940094 being better than placebo⩾88%) was not met (82.9%). LY2940094 also had an early effect on the processing of emotional stimuli at Week 1 as shown by an increased recognition of positive relative to negative facial expressions in an emotional test battery. LY2940094 was safe and well tolerated. Overall, these are the first human data providing evidence that the blockade of NOP receptor signaling represents a promising strategy for the treatment of MDD. PMID:26585287

An efficient grid layout algorithm for biological networks utilizing various biological attributes

PubMed Central

Kojima, Kaname; Nagasaki, Masao; Jeong, Euna; Kato, Mitsuru; Miyano, Satoru

2007-01-01

Background Clearly visualized biopathways provide a great help in understanding biological systems. However, manual drawing of large-scale biopathways is time consuming. We proposed a grid layout algorithm that can handle gene-regulatory networks and signal transduction pathways by considering edge-edge crossing, node-edge crossing, distance measure between nodes, and subcellular localization information from Gene Ontology. Consequently, the layout algorithm succeeded in drastically reducing these crossings in the apoptosis model. However, for larger-scale networks, we encountered three problems: (i) the initial layout is often very far from any local optimum because nodes are initially placed at random, (ii) from a biological viewpoint, human layouts still exceed automatic layouts in understanding because except subcellular localization, it does not fully utilize biological information of pathways, and (iii) it employs a local search strategy in which the neighborhood is obtained by moving one node at each step, and automatic layouts suggest that simultaneous movements of multiple nodes are necessary for better layouts, while such extension may face worsening the time complexity. Results We propose a new grid layout algorithm. To address problem (i), we devised a new force-directed algorithm whose output is suitable as the initial layout. For (ii), we considered that an appropriate alignment of nodes having the same biological attribute is one of the most important factors of the comprehension, and we defined a new score function that gives an advantage to such configurations. For solving problem (iii), we developed a search strategy that considers swapping nodes as well as moving a node, while keeping the order of the time complexity. Though a naïve implementation increases by one order, the time complexity, we solved this difficulty by devising a method that caches differences between scores of a layout and its possible updates. Conclusion Layouts of the new grid layout algorithm are compared with that of the previous algorithm and human layout in an endothelial cell model, three times as large as the apoptosis model. The total cost of the result from the new grid layout algorithm is similar to that of the human layout. In addition, its convergence time is drastically reduced (40% reduction). PMID:17338825

A randomized, double-blind, 24-week study of escitalopram (10 mg/day) versus citalopram (20 mg/day) in primary care patients with major depressive disorder.

PubMed

Colonna, Lucien; Andersen, Henning Friis; Reines, Elin Heldbo

2005-10-01

A randomized, double-blind, 24-week-fixed-dose study comparing the efficacy and safety of escitalopram to that of citalopram was safety was conducted in primary care patients with moderate to severe major depressive disorder (MDD). This was a randomized, double-blind, 24-week fixeddose study. Patients were randomly assigned to treatment with escitalopram 10 mg/day (n = 175) or citalopram 20 mg/day (n = 182). Clinical response was evaluated using the Montgomery-Asberg Depression Rating Scale (MADRS) and Clinical Global Impression-Severity (CGI-S) scale. The prospectively defined primary parameter of antidepressant efficacy was the change from baseline in the mean MADRS total score during the 24 weeks of double-blind treatment, using a repeated measures analysis of variance to compare the treatment groups over all assessment points simultaneously. Based on the primary parameter, escitalopram was at least as efficacious as citalopram. Based on the prospectively defined secondary parameter, mean change from baseline in the CGI-S score, escitalopram was statistically significantly superior to citalopram at Week 24. The importance of long-term treatment could be demonstrated, in that more than half (55% and 51%) of the patients who had not responded by Week 8 achieved remission by Week 24. Both escitalopram and citalopram were safe and well tolerated in acute and long-term treatment, and the overall adverse event profiles for the two drugs were similar. For the intent-to-treat population, there were statistically significantly fewer withdrawals in the escitalopram group than in the citalopram group, particularly after Week 8. Patients with MDD responded well to long-term treatment with either escitalopram or citalopram. This study demonstrated the importance of extending treatment of depression beyond 8 weeks.

Effect of sugar-sweetened beverages on body weight in children: design and baseline characteristics of the Double-blind, Randomized INtervention study in Kids.

PubMed

de Ruyter, Janne Catharine; Olthof, Margreet Renate; Kuijper, Lothar David Jan; Katan, Martijn Bernard

2012-01-01

Intake of sugar-sweetened beverages is associated with overweight in observational studies. A possible explanation is that liquid sugars do not satiate and that their intake is not compensated by reduced caloric intake from other foods. However, evidence from intervention studies for this hypothesis is inconclusive because previous studies were not blinded. Hence results may have been influenced by expectations and behavioral cues rather than by physiological mechanisms. We designed the Double-blind, Randomized INtervention study in Kids (DRINK) to examine the effect on body weight of covertly replacing sugar-sweetened by sugar-free beverages. Children were only eligible if they habitually drank sugar-sweetened beverages. We recruited 642 healthy children (mean age 8.2, range 4.8-11.9). We designed, tested and produced custom-made beverages containing 10% sugar and sugar-free beverages with the same sweet taste and look. Children receive one 250 mL can of study beverage daily for 18 months. We perform body measurements at 0, 6, 12 and 18 months. The primary outcome is the z-score of BMI for age. The maximum predicted difference in this score between groups is 0.72, which corresponds with a difference in body weight of 2.3 kg. The double-blind design eliminates behavioral factors that affect body weight. If children gain less body fat when drinking sugar-free than when drinking sugar-sweetened beverages that would show that liquid sugar indeed bypasses biological satiation mechanisms. It would also suggest that a reduction in liquid sugars could decrease body fat more effectively than reduction of other calorie sources. Copyright © 2011 Elsevier Inc. All rights reserved.

SLO blind data set inversion and classification using physically complete models

NASA Astrophysics Data System (ADS)

Shamatava, I.; Shubitidze, F.; Fernández, J. P.; Barrowes, B. E.; O'Neill, K.; Grzegorczyk, T. M.; Bijamov, A.

2010-04-01

Discrimination studies carried out on TEMTADS and Metal Mapper blind data sets collected at the San Luis Obispo UXO site are presented. The data sets included four types of targets of interest: 2.36" rockets, 60-mm mortar shells, 81-mm projectiles, and 4.2" mortar items. The total parameterized normalized magnetic source (NSMS) amplitudes were used to discriminate TOI from metallic clutter and among the different hazardous UXO. First, in object's frame coordinate, the total NSMS were determined for each TOI along three orthogonal axes from the training data provided by the Strategic Environmental Research and Development Program (SERDP) along with the referred blind data sets. Then the inverted total NSMS were used to extract the time-decay classification features. Once our inversion and classification algorithms were tested on the calibration data sets then we applied the same procedure to all blind data sets. The combined NSMS and differential evolution algorithm is utilized for determine the NSMS strengths for each cell. The obtained total NSMS time-decay curves were used to extract the discrimination features and perform classification using the training data as reference. In addition, for cross validation, the inverted locations and orientations from NSMS-DE algorithm were compared against the inverted data that obtained via the magnetic field, vector and scalar potentials (HAP) method and the combined dipole and Gauss-Newton approach technique. We examined the entire time decay history of the total NSMS case-by-case for classification purposes. Also, we use different multi-class statistical classification algorithms for separating the dangerous objects from non hazardous items. The inverted targets were ranked by target ID and submitted to SERDP for independent scoring. The independent scoring results are presented.

Quality of life of the most severely vision-impaired.

PubMed

Crewe, Julie M; Morlet, Nigel; Morgan, William H; Spilsbury, Katrina; Mukhtar, Aqif; Clark, Antony; Ng, Jonathon Q; Crowley, Margaret; Semmens, James B

2011-01-01

To explore the interaction between vision impairment, perceived quality of life loss and willingness to trade remaining life for vision gain. Community-based cross-sectional study. Legally blind or severely vision-impaired people selected randomly from the Association for the Blind of Western Australia register. Individuals were examined by consultant ophthalmologists and completed the Impact of Vision Impairment profile quality of life assessment and a Time Trade-Off evaluation. Vision-related utility values were calculated. The results were analysed using univariate and multivariate regression methods. IVI Rasch Logits and TTO utility values (TTO UV). 156 people volunteered to contribute to the study. The median age was 80 (19-97) years, and 56% were female. Being legally blind (logMAR > 1) (95% CI 1.1 to 5.2, P = 0.003), clinically depressed (95% CI -11.2 to -1.8, P = 0.007) or more than 40 years of age (95% CI 0.9 to 8.1, P = 0.015) significantly lowered overall impact of vision impairment scores. The emotional domain of impact of vision impairment was associated with willingness to trade part of remaining life. A 5-Logit increase in impact of vision impairment emotional score resulted in a 21% (95% CI 10 to 31) decrease in the odds of being likely to trade life for sight. The Australian definition of blindness compared with World Health Organisation or USA best separates those with perceived loss and appears useful in identifying vision loss-related morbidity. These results suggest that emotional health and lack of depression are important determinants for quality and value of life. © 2011 The Authors. Clinical and Experimental Ophthalmology © 2011 Royal Australian and New Zealand College of Ophthalmologists.

Investigating the use of an antiscatter grid in chest radiography for average adults with a computed radiography imaging system

PubMed Central

Wood, T J; Avery, G; Balcam, S; Needler, L; Smith, A; Saunderson, J R; Beavis, A W

2015-01-01

Objective: The aim of this study was to investigate via simulation a proposed change to clinical practice for chest radiography. The validity of using a scatter rejection grid across the diagnostic energy range (60–125 kVp), in conjunction with appropriate tube current–time product (mAs) for imaging with a computed radiography (CR) system was investigated. Methods: A digitally reconstructed radiograph algorithm was used, which was capable of simulating CR chest radiographs with various tube voltages, receptor doses and scatter rejection methods. Four experienced image evaluators graded images with a grid (n = 80) at tube voltages across the diagnostic energy range and varying detector air kermas. These were scored against corresponding images reconstructed without a grid, as per current clinical protocol. Results: For all patients, diagnostic image quality improved with the use of a grid, without the need to increase tube mAs (and therefore patient dose), irrespective of the tube voltage used. Increasing tube mAs by an amount determined by the Bucky factor made little difference to image quality. Conclusion: A virtual clinical trial has been performed with simulated chest CR images. Results indicate that the use of a grid improves diagnostic image quality for average adults, without the need to increase tube mAs, even at low tube voltages. Advances in knowledge: Validated with images containing realistic anatomical noise, it is possible to improve image quality by utilizing grids for chest radiography with CR systems without increasing patient exposure. Increasing tube mAs by an amount determined by the Bucky factor is not justified. PMID:25571914

Atomoxetine effects on executive function as measured by the BRIEF--a in young adults with ADHD: a randomized, double-blind, placebo-controlled study.

PubMed

Adler, Lenard A; Clemow, David B; Williams, David W; Durell, Todd M

2014-01-01

To evaluate the effect of atomoxetine treatment on executive functions in young adults with attention-deficit/hyperactivity disorder (ADHD). In this Phase 4, multi-center, double-blind, placebo-controlled trial, young adults (18-30 years) with ADHD were randomized to receive atomoxetine (20-50 mg BID, N = 220) or placebo (N = 225) for 12 weeks. The Behavior Rating Inventory of Executive Function-Adult (BRIEF-A) consists of 75 self-report items within 9 nonoverlapping clinical scales measuring various aspects of executive functioning. Mean changes from baseline to 12-week endpoint on the BRIEF-A were analyzed using an ANCOVA model (terms: baseline score, treatment, and investigator). At baseline, there were no significant treatment group differences in the percentage of patients with BRIEF-A composite or index T-scores ≥60 (p>.5), with over 92% of patients having composite scores ≥60 (≥60 deemed clinically meaningful for these analyses). At endpoint, statistically significantly greater mean reductions were seen in the atomoxetine versus placebo group for the BRIEF-A Global Executive Composite (GEC), Behavioral Regulation Index (BRI), and Metacognitive Index (MI) scores, as well as the Inhibit, Self-Monitor, Working Memory, Plan/Organize and Task Monitor subscale scores (p<.05), with decreases in scores signifying improvements in executive functioning. Changes in the BRIEF-A Initiate (p = .051), Organization of Materials (p = .051), Shift (p = .090), and Emotional Control (p = .219) subscale scores were not statistically significant. In addition, the validity scales: Inconsistency (p = .644), Infrequency (p = .097), and Negativity (p = .456) were not statistically significant, showing scale validity. Statistically significantly greater improvement in executive function was observed in young adults with ADHD in the atomoxetine versus placebo group as measured by changes in the BRIEF-A scales. ClinicalTrials.gov NCT00510276.

Atomoxetine Effects on Executive Function as Measured by the BRIEF-A in Young Adults with ADHD: A Randomized, Double-Blind, Placebo-Controlled Study

PubMed Central

Adler, Lenard A.; Clemow, David B.; Williams, David W.; Durell, Todd M.

2014-01-01

Objective To evaluate the effect of atomoxetine treatment on executive functions in young adults with attention-deficit/hyperactivity disorder (ADHD). Methods In this Phase 4, multi-center, double-blind, placebo-controlled trial, young adults (18–30 years) with ADHD were randomized to receive atomoxetine (20–50 mg BID, N = 220) or placebo (N = 225) for 12 weeks. The Behavior Rating Inventory of Executive Function-Adult (BRIEF-A) consists of 75 self-report items within 9 nonoverlapping clinical scales measuring various aspects of executive functioning. Mean changes from baseline to 12-week endpoint on the BRIEF-A were analyzed using an ANCOVA model (terms: baseline score, treatment, and investigator). Results At baseline, there were no significant treatment group differences in the percentage of patients with BRIEF-A composite or index T-scores ≥60 (p>.5), with over 92% of patients having composite scores ≥60 (≥60 deemed clinically meaningful for these analyses). At endpoint, statistically significantly greater mean reductions were seen in the atomoxetine versus placebo group for the BRIEF-A Global Executive Composite (GEC), Behavioral Regulation Index (BRI), and Metacognitive Index (MI) scores, as well as the Inhibit, Self-Monitor, Working Memory, Plan/Organize and Task Monitor subscale scores (p<.05), with decreases in scores signifying improvements in executive functioning. Changes in the BRIEF-A Initiate (p = .051), Organization of Materials (p = .051), Shift (p = .090), and Emotional Control (p = .219) subscale scores were not statistically significant. In addition, the validity scales: Inconsistency (p = .644), Infrequency (p = .097), and Negativity (p = .456) were not statistically significant, showing scale validity. Conclusion Statistically significantly greater improvement in executive function was observed in young adults with ADHD in the atomoxetine versus placebo group as measured by changes in the BRIEF-A scales. Trial Registration ClinicalTrials.gov NCT00510276 PMID:25148243

Randomized double-blinded placebo-controlled intra-individual trial on topical treatment with a 1,25-dihydroxyvitamin D₃ analogue in polymorphic light eruption.

PubMed

Gruber-Wackernagel, A; Bambach, I; Legat, F J; Hofer, A; Byrne, S N; Quehenberger, F; Wolf, P

2011-07-01

Polymorphic light eruption (PLE) is a very frequent photodermatosis whose pathogenesis may involve resistance to ultraviolet (UV)-induced immune suppression. Similar to UV radiation, calcitriol (1,25-dihydroxyvitamin D₃) and its analogues such as calcipotriol have been shown to exhibit immunosuppressive properties. We performed a randomized double-blinded placebo-controlled intraindividual half-body trial (NCT00871052) to investigate the preventive effect of a calcipotriol-containing cream in PLE. Thirteen patients with PLE (10 women, three men; mean age 37 years) pretreated their skin on two symmetrically located test fields with calcipotriol or placebo cream twice daily for 7 days before the start of photoprovocation testing with solar-simulated UV radiation. We established a specific PLE test score [AA + SI + 0·4 P (range 0-12), where AA is affected area score (range 0-4), SI is skin infiltration score (range 0-4) and P is pruritus score on a visual analogue scale (range 0-10)] to quantify PLE severity. Photoprovocation led to PLE lesions in 12/13 (92%) patients. As shown by the PLE test score, compared with placebo calcipotrial pretreatment significantly reduced PLE symptoms in average by 32% (95% confidence interval 21-44%; P = 0·0022, exact Wilcoxon signed-rank test) throughout the observation period starting at 48 h until 144 h after the first photoprovocation exposure. At 48, 72 and 144 h calcipotriol pretreatment resulted in a lower PLE test score in 7 (58%), 9 (75%) and 10 (83%) of the 12 cases, respectively. Considering all time points together, calcipotriol diminished the PLE test score in all 12 photoprovocable patients (P = 0·0005; Wilcoxon signed-rank test). These results suggest a potential therapeutic benefit of topical 1,25-dihydroxyvitamin D₃ analogues as prophylactic treatment in patients with PLE. © 2011 The Authors. BJD © 2011 British Association of Dermatologists 2011.

Association between desloratadine and prednisolone in the treatment of children with acute symptoms of allergic rhinitis: a double-blind, randomized and controlled clinical trial.

PubMed

Wandalsen, Gustavo F; Miranda, Carolina; Ensina, Luis Felipe; Sano, Flavio; Amazonas, Roberto Bleul; Silva, Joyce Macedo da; Solé, Dirceu

A combination of antihistamines and oral corticosteroids is often used to treat acute symptoms of allergic rhinitis. To evaluate safety and efficacy of desloratadine plus prednisolone in the treatment of acute symptoms of children (2-12 years) with allergic rhinitis, and to compare it to dexchlorpheniramine plus betamethasone. Children with moderate/severe persistent allergic rhinitis and symptomatic (nasal symptoms score [0-12]≥6) were allocated in a double-blind, randomized fashion to receive dexchlorpheniramine plus betamethasone (n=105; three daily doses) or desloratadine plus prednisolone (n=105; single dose followed by two of placebo) for 7 days. At the beginning and end of the evaluation, the following were obtained: nasal symptoms score, extra nasal symptoms score, peak nasal inspiratory flow, blood biochemistry, and electrocardiogram. Ninety-six children of the dexchlorpheniramine plus betamethasone group and 98 of the desloratadine plus prednisolone group completed the protocol. The two groups were similar regarding initial and final nasal symptoms scores, extra nasal symptoms scores and peak nasal inspiratory flow. A drop of 76.4% and 79.1% for nasal symptoms score, 86.0% and 79.2% for extra nasal symptoms score, as well as an increase of 25.2% and 24.3% for peak nasal inspiratory flow occurred for those treated with desloratadine plus prednisolone and dexchlorpheniramine plus betamethasone, respectively. There were no significant changes in blood chemistry. Sinus tachycardia was the most frequent electrocardiogram change, but with no clinical significance. Drowsiness was reported significantly more often among those of dexchlorpheniramine plus betamethasone group (17.14%×8.57%, respectively). The desloratadine plus prednisolone combination was able to effectively control acute symptoms of rhinitis in children, improving symptoms and nasal function. Compared to the dexchlorpheniramine plus betamethasone combination, it showed similar clinical action, but with a lower incidence of adverse events and higher dosing convenience. Copyright © 2016. Published by Elsevier Editora Ltda.

Impairment-oriented training or Bobath therapy for severe arm paresis after stroke: a single-blind, multicentre randomized controlled trial.

PubMed

Platz, T; Eickhof, C; van Kaick, S; Engel, U; Pinkowski, C; Kalok, S; Pause, M

2005-10-01

To study the effects of augmented exercise therapy time for arm rehabilitation as either Bobath therapy or the impairment-oriented training (Arm BASIS training) in stroke patients with arm severe paresis. Single blind, multicentre randomized control trial. Three inpatient neurorehabilitation centres. Sixty-two anterior circulation ischaemic stroke patients. Random assignment to three group: (A) no augmented exercise therapy time, (B) augmented exercise therapy time as Bobath therapy and (C) augmented exercise therapy time as Arm BASIS training. Fugl-Meyer arm motor score. Secondary measure: Action Research Arm Test (ARA). Ancillary measures: Fugl-Meyer arm sensation and joint motion/pain scores and the Ashworth Scale (elbow flexors). An overall effect of augmented exercise therapy time on Fugl-Meyer scores after four weeks was not corroborated (mean and 95% confidence interval (CI) of change scores: no augmented exercise therapy time (n=20) 8.8, 5.2-12.3; augmented exercise therapy time (n=40) 9.9, 6.8-13.9; p = 0.2657). The group who received the augmented exercise therapy time as Arm BASIS training (n=20) had, however, higher gains than the group receiving the augmented exercise therapy time as Bobath therapy (n=20) (mean and 95% CI of change scores: Bobath 7.2, 2.6-11.8; BASIS 12.6, 8.4-16.8; p = 0.0432). Passive joint motion/pain deteriorated less in the group who received BASIS training (mean and 95% CI of change scores: Bobath -3.2, -5.2 to -1.1; BASIS 0.1, -1.8-2.0; p = 0.0090). ARA, Fugl-Meyer arm sensation, and Ashworth Scale scores were not differentially affected. The augmented exercise therapy time as Arm BASIS training enhanced selective motor control. Type of training was more relevant for recovery of motor control than therapeutic time spent.

Maternal kisses are not effective in alleviating minor childhood injuries (boo-boos): a randomized, controlled and blinded study.

PubMed

2015-12-01

The practice of maternal kissing of minor injuries of childhood (boo-boos), though widely endorsed and practised, has never been demonstrated to be of benefit to children. To determine the efficacy, if any, of maternal kissing of boo-boos in toddlers. Randomized, controlled and double-blinded study of children with experimentally induced minor injuries. Control arms included both no intervention group and 'sham' (non-maternal) kissing. Children were blinded to the identity of the kisser in both the maternal and sham control groups. Outpatient research clinics in Ottawa, Canada. 943 maternal-toddler pairs recruited from the community. Toddler Discomfort Index (TDI) pre-injury, 1 and 5 minutes post-injury. One-minute and 5-minute TDI scores did not differ significantly between the maternal and sham kiss groups. Both of these groups had significantly higher TDI scores at 5 minutes compared to the no intervention group. Maternal kissing of boo-boos confers no benefit on children with minor traumatic injuries compared to both no intervention and sham kissing. In fact, children in the maternal kissing group were significantly more distressed at 5 minutes than were children in the no intervention group. The practice of maternal kissing of boo-boos is not supported by the evidence and we recommend a moratorium on the practice. © 2015 John Wiley & Sons, Ltd.

2 L PEG plus ascorbic acid versus 4 L PEG plus simethicon for colonoscopy preparation: a randomized single-blind clinical trial.

PubMed

Gentile, Maurizio; De Rosa, Michele; Cestaro, Giovanni; Forestieri, Pietro

2013-06-01

The 2 L polyethylene glycol (PEG) lavage solution has been proved to be similarly safe and effective as 4 L PEG formulations, in spite of the reduced volume. To compare low-volume PEG-based solution combined with ascorbic acid with high-volume PEG-based solution combined with simethicon in terms of efficacy and patient tolerability. This was a single-blind prospective randomized trial. Patients were randomized to receive either 2 L PEG plus ascorbic acid (PEG+Asc) or 4 L PEG plus simethicon (PEG+Sim). The primary endpoint was overall colon cleansing evaluation, assessed by blinded investigators using Aronchick score. Secondary end points included patient compliance and tolerability and adverse events. Sixty patients received PEG+Asc and 60 received PEG+Sim. Overall bowel cleansing score was considered adequate in 81.67% of the PEG+Asc and 80% of the PEG+Sim groups, respectively. Excellent and good ratings were recorded in 11.6% and 38.3% receiving PEG+Asc as compared with 26.6% and 23.3% of patients receiving PEG+Sim. Patient tolerability and safety were similar with both the preparations. According to our data, low-volume PEG+Asc has comparable efficacy, safety, and tolerability as high-volume PEG+Sim; therefore, it can be considered as a good alternative solution for bowel preparation. More improvements are necessary to achieve the target of a perfect preparation.

The efficacy of cetirizine hydrochloride on the pruritus of cats with atopic dermatitis: a randomized, double-blind, placebo-controlled, crossover study.

PubMed

Wildermuth, Kerstin; Zabel, Sonja; Rosychuk, Rod A W

2013-12-01

Various antihistamines have been used in the management of feline atopic dermatitis, with variable reported benefit. To date, there have been no randomized, double-blind, placebo-controlled, crossover clinical trials on the use of this drug class in cats. To evaluate the clinical efficacy of cetirizine hydrochloride for the control of pruritus and dermatitis in cats diagnosed with atopic dermatitis. In this randomized, double-blind, placebo-controlled crossover clinical trial, 21 client-owned cats diagnosed with mild to moderate nonseasonal atopic dermatitis were randomly assigned to two groups. Cats in each group received either 1 mg/kg cetirizine hydrochloride or placebo once daily per os for 28 days followed by a 14 day wash-out period. Treatments were then crossed over, and cats received placebo or cetirizine hydrochloride for another 28 days. Owners marked a pruritus severity scale before inclusion in the study and weekly throughout the entire study period. Lesions were scored by the clinician using a Canine Atopic Dermatitis Extent and Severity Index (CADESI)-03 modified for the cat before enrolment and at day 28 of each treatment. Nineteen cats completed the study. There were no statistically significant differences between treatment with cetirizine hydrochloride and placebo for modified CADESI-03 or pruritus scores. This study suggests that cetirizine hydrochloride cannot be recommended for the management of feline atopic dermatitis. © 2013 ESVD and ACVD.

The effect of benzocaine and ketoprofen gels on pain during fixed orthodontic appliance treatment: a randomised, double-blind, crossover trial.

PubMed

Eslamian, Ladan; Borzabadi-Farahani, Ali; Gholami, Hadi

2016-05-01

To compare the analgesic effect of topical benzocaine (5%) and ketoprofen (1.60 mg/mL) after 2 mm activation of 7 mm long delta loops used for maxillary en-masse orthodontic space closure. Twenty patients (seven males, 13 females, 15-25 years of age, mean age of 19.5 years) participated in a randomised crossover, double-blind trial. After appliance activation, participants were instructed to use analgesic gels and record pain perception at 2, 6, 24 hours and 2, 3 and 7 days (at 18.00 hrs), using a visual analogue scale ruler (VAS, 0-4). Each patient received all three gels (benzocaine, ketoprofen, and a control (placebo)) randomly, but at three different appliance activation visits following a wash-over gap of one month. After the first day, the patients were instructed to repeat gel application twice a day at 10:00 and 18:00 hrs for three days. The recorded pain scores were subjected to non-parametric analysis. The highest pain was recorded at 2 and 6 hours. Pain scores were significantly different between the three groups (Kruskal-Wallis test, p < 0.01). The overall mean (SD) pain scores for the benzocaine 5%, ketoprofen, and control (placebo) groups were 0.89 (0.41), 0.68 (0.34), and 1.15 (0.81), respectively. The pain scores were significantly different between the ketoprofen and control groups (mean difference = 0.47, p = 0.005). All groups demonstrated significant differences in pain scores at the six different time intervals (p < 0.05) and there was no gender difference (p > 0.05). A significant pain reduction was observed following the use of ketoprofen when tested against a control gel (placebo). The highest pain scores were experienced in patients administered the placebo and the lowest scores in patients who applied ketoprofen gel. Benzocaine had an effect mid-way between ketoprofen and the placebo. The highest pain scores were recorded 2 hours following force application, which decreased to the lowest scores after 7 days.

Placebo Effects and the Common Cold: A Randomized Controlled Trial

PubMed Central

Barrett, Bruce; Brown, Roger; Rakel, Dave; Rabago, David; Marchand, Lucille; Scheder, Jo; Mundt, Marlon; Thomas, Gay; Barlow, Shari

2011-01-01

PURPOSE We wanted to determine whether the severity and duration of illness caused by the common cold are influenced by randomized assignment to open-label pills, compared with conventional double-blind allocation to active and placebo pills, compared with no pills at all. METHODS We undertook a randomized controlled trial among a population with new-onset common cold. Study participants were allocated to 4 parallel groups: (1) those receiving no pills, (2) those blinded to placebo, (3) those blinded to echinacea, and (4) those given open-label echinacea. Primary outcomes were illness duration and area-under-the-curve global severity. Secondary outcomes included neutrophil count and interleukin 8 levels from nasal wash at intake and 2 days later. RESULTS Of 719 randomized study participants, 2 were lost and 4 exited early. Participants were 64% female, 88% white, and aged 12 to 80 years. Mean illness duration for each group was 7.03 days for those in the no-pill group, 6.87 days for those blinded to placebo, 6.34 days for those blinded to echinacea, and 6.76 days for those in the open-label echinacea group. Mean global severity scores for the 4 groups were no pills, 286; blinded to placebo, 264; blinded to echinacea, 236; and open-label echinacea, 258. Between-group differences were not statistically significant. Comparing the no-pill with blinded to placebo groups, differences (95% confidence interval [CI]) were −0.16 days (95% CI, −0.90 to 0.58 days) for illness duration and −22 severity points (95% CI, −70 to 26 points) for global severity. Comparing the group blinded to echinacea with the open-label echinacea group, differences were 0.42 days (95% CI, −0.28 to 1.12 days) and 22 severity points (95% CI, −19 to 63 points). Median change in interleukin 8 concentration and neutrophil cell count, respectively by group, were 30 pg/mL and 1 cell for the no-pill group, 39 pg/mL and 1 cell for the group binded to placebo, 58 pg/mL and 2 cells for the group blinded to echinacea, and 70 pg/mL and 1 cell for the group with open-label echinacea, also not statistically significant. Among the 120 participants who at intake rated echinacea’s effectiveness as greater than 50 on a 100-point scale for which 100 is extremely effective, illness duration was 2.58 days shorter (95% CI, −4.47 to −0.68 days) in those blinded to placebo rather than no pill, and mean global severity score was 26% lower but not significantly different (−97.0, 95% CI, −249.8 to 55.8 points). In this subgroup, neither duration nor severity differed significantly between the group blinded to echinacea and the open-label echinacea group. CONCLUSIONS Participants randomized to the no-pill group tended to have longer and more severe illnesses than those who received pills. For the subgroup who believed in echinacea and received pills, illnesses were substantively shorter and less severe, regardless of whether the pills contained echinacea. These findings support the general idea that beliefs and feelings about treatments may be important and perhaps should be taken into consideration when making medical decisions. PMID:21747102

The immediate use of a silicone sheet wound closure device in scar reduction and prevention.

PubMed

Parry, James R; Stupak, Howard D; Johnson, Calvin M

2016-02-01

Silicone has been used successfully postoperatively in the prevention of hypertrophic and other types of adverse scars. The Silicone Suture Plate (SSP) is a new, minimally invasive, sterile wound closure device that is applied intraoperatively to prevent adverse scarring. The SSP device permits immediate application of silicone while concurrently allowing for wound-edge tension redistribution. In this prospective, controlled, single-blinded clinical study, 8 consecutive patients undergoing deep-plane rhytidectomy were selected. SSP devices were placed on the patients' posterior rhytidectomy hairline incision; the mirror-image control site underwent standard suturing techniques. Three blinded, independent raters assessed the treatment and control sides at 6-week and 4-month follow-up visits, using the Objective Scar Assessment Scale (OSAS), a validated scar assessment tool. The 6-week OSAS scores revealed an 18.4% improvement on the side with the SSP device (13.3) when compared to the control side (16.3). The 4-month OSAS scores showed a 27.3% improvement on the treatment side from 12.7 (control) to 9.2 (SSP). These OSAS results were found to be statistically significant when taken as an aggregate of the observers' scores, but not when observers' scores were measured individually (p < 0.05). In our series of patients, we showed promising results with the use of the SSP device. Early silicone application and tissue tension distribution contributed to an overall more aesthetically pleasing scar compared to those seen with standard suturing techniques, although more testing is required.

Botulinum toxin, a new treatment modality for chronic idiopathic constipation in children: long-term follow-up of a double-blind randomized trial.

PubMed

Keshtgar, Alireza S; Ward, Harry C; Sanei, Ahmad; Clayden, Graham S

2007-04-01

Myectomy of the internal anal sphincter (IAS) has been performed on some children after failure of medical treatment to treat idiopathic constipation. The aim of this study was to compare botulinum toxin injection with myectomy of the IAS in the treatment of chronic idiopathic constipation and soiling in children. This was a double-blind randomized trial. Patients between 4 and 16 years old were included in the study if they had failed to respond to laxative treatment and anal dilatation for chronic idiopathic constipation. All study patients had anorectal manometry and anal endosonography under ketamine anesthesia. Outcome was measured using a validated symptom severity (SS) scoring system, with scores ranging from 0 to 65. Of 42 children, 21 were randomized to the botulinum group and 21 were randomized to the myectomy group. At the 3-month follow-up, the median preoperative SS score improved from 34 (range = 19-47) to 20 (range = 2-43) in the botulinum group (P < .001) and from 31 (range = 18-49) to 19 (range = 3-47) in the myectomy group (P < .002). At the 12-month follow-up, the scores were 19 (range = 0-45) and 14.5 (range = 0-41) for the botulinum group and the myectomy group, respectively (P < .0001). There was no complication in both groups. Botulinum toxin is equally effective as and less invasive than myectomy of the IAS for chronic idiopathic constipation and fecal incontinence in children.

Clinical effects of Lactobacillus acidophilus strain L-92 on perennial allergic rhinitis: a double-blind, placebo-controlled study.

PubMed

Ishida, Y; Nakamura, F; Kanzato, H; Sawada, D; Hirata, H; Nishimura, A; Kajimoto, O; Fujiwara, S

2005-02-01

Studies in animals have suggested that lactic acid bacteria alleviate allergic diseases, however, little information is available on their clinical effect on allergy in humans. Thus, we examined the efficacy of orally administered Lactobacillus acidophilus strain L-92 (L-92) on perennial allergic rhinitis. In a randomized, double-blind, placebo-controlled clinical trial, 49 patients with perennial allergic rhinitis were randomized to receive either 100 mL of heat-treated fermented milk containing L-92 (n = 25) or acidified milk without lactic acid bacteria (placebo; n = 24) for 8 wk. The severity of symptoms was evaluated based on the changes in the scores of clinical symptoms. Oral administration of milk fermented with L-92 resulted in a statistically significant improvement of nasal symptom-medication scores. Ocular symptom-medication scores of patients in the L-92 intervention group tended to improve compared with those in the placebo group. In addition, clear decreases of the scores of swelling and color of the nasal mucosa were observed in the L-92 intervention group at 6 and 8 wk after the start of ingestion of fermented milk. There were no significant differences in serum antihouse dust mite immunoglobulin E levels nor in T helper type 1/T helper type 2 ratio between the 2 groups. These results suggest that oral administration of L-92 can alleviate the symptoms of perennial allergic rhinitis, however, statistically significant changes were not shown in blood parameters.

Aural stimulation with capsaicin ointment improved swallowing function in elderly patients with dysphagia: a randomized, placebo-controlled, double-blind, comparative study.

PubMed

Kondo, Eiji; Jinnouchi, Osamu; Nakano, Seiichi; Ohnishi, Hiroki; Kawata, Ikuji; Okamoto, Hidehiko; Takeda, Noriaki

2017-01-01

The aim of this study was to assess whether aural stimulation with ointment containing capsaicin improves swallowing function in elderly patients with dysphagia. A randomized, placebo-controlled, double-blind, comparative study. Secondary hospital. Twenty elderly dysphagic patients with a history of cerebrovascular disorder or Parkinson's disease were randomly divided into two groups: 10 receiving aural stimulation with 0.025% capsaicin ointment and 10 stimulated with placebo. The ointments were applied to the external auditory canal with a cotton swab. Then, swallowing of a bolus of blue-dyed water was recorded using transnasal videoendoscopy, and the swallowing function was evaluated according to both endoscopic swallowing scoring and Sensory-Motor-Reflex-Clearance (SMRC) scale. The sum of endoscopic swallowing scores was significantly decreased 30 and 60 min after a single administration in patients treated with capsaicin, but not with placebo. Reflex score, but not Sensory, Motion and Clearance scores, of the SMRC scale was significantly increased 5, 30 and 60 min after single administration in patients treated with capsaicin, but not with placebo. No patient showed signs of adverse effects. As capsaicin is an agonist of the transient receptor potential vanilloid 1 (TRPV1), these findings suggest that improvement of the swallowing function, especially glottal closure and cough reflexes, in elderly dysphagic patients was due to TRPV1-mediated aural stimulation of vagal Arnold's nerve with capsaicin, but not with a nonspecific mechanical stimulation with a cotton swab.

Ondansetron does not prevent physical dependence in patients taking opioid medications chronically for pain control.

PubMed

Chu, Larry F; Rico, Tom; Cornell, Erika; Obasi, Hannah; Encisco, Ellen M; Vertelney, Haley; Gamble, Jamison G; Crawford, Clayton W; Sun, John; Clemenson, Anna; Erlendson, Matthew J; Okada, Robin; Carroll, Ian; Clark, J David

2018-02-01

In this study, we investigated the co-administration of ondansetron with morphine, and whether it could prevent the development of physical dependence in patients taking opioids for the treatment of chronic pain. A total of 48 chronic back pain patients (N = 48) participated in this double-blinded, placebo-controlled, randomized study. Patients were titrated onto sustained-release oral morphine and randomized to take 8 mg ondansetron or placebo three times daily concurrently with morphine during the 30-day titration. Following titration, patients underwent Naloxone induced opioid withdrawal. Opioid withdrawal signs and symptoms were then assessed by a blinded research assistant (objective opioid withdrawal score: OOWS) and by the research participant (subjective opioid withdrawal score: SOWS). We observed clinically significant signs of naloxone-precipitated opioid withdrawal in all participants (ΔOOWS = 4.3 ± 2.4, p < 0.0001; ΔSOWS = 14.1 ± 11.7, p < 0.0001), however no significant differences in withdrawal scores were detected between treatment groups. We hypothesized that ondansetron would prevent the development of physical dependence in human subjects when co-administered with opioids, but found no difference in naloxone-precipitated opioid withdrawal scores between ondansetron and placebo treatment groups. These results suggest that further studies are needed to determine if 5HT 3 receptor antagonists are useful in preventing opioid physical dependence. Copyright © 2017 Elsevier B.V. All rights reserved.

Efficacy of Tribulus Terrestris for the treatment of premenopausal women with hypoactive sexual desire disorder: a randomized double-blinded, placebo-controlled trial.

PubMed

Vale, Fabiene Bernardes Castro; Zanolla Dias de Souza, Karla; Rezende, Camilla Russi; Geber, Selmo

2018-05-01

Although hypoactive sexual desire disorder (HSDD) is the most common sexual complaint, there is no consensus for the ideal treatment. Our study aimed to evaluate the efficacy of treating premenopausal women with HSDD with Tribulus terrestris and its effect on the serum levels of testosterone. We performed a prospective, randomized, double-blind, placebo-controlled trial, with 40 premenopausal women reporting diminished libido, receiving T. terrestris or placebo. The questionnaires FSFI and the QS-F were used to evaluate sexual dysfunction before and after treatment. Patients treated with T. terrestris experienced improvement in total score of FSFI (p < .001) and domains "desire" (p < .001), "sexual arousal" (p = .005), "lubrication" (p = .001), "orgasm" (p <.001), "pain" (p = .030) and "satisfaction" (p = .001). Treatment with placebo did not improve the scores for the "lubrication" and "pain". QS-F scores showed that patients using T. terrestris had improvements in "desire" (p = .012), "sexual arousal/lubrication" (p = .002), "pain" (p = .031), "orgasm" (p = .004) and "satisfaction" (p = .001). Women treated with placebo did not score improvements. Women receiving T. terrestris had increased levels of free (p = .046) and bioavailable (p < .048) testosterone. T. terrestris might be a safe alternative for the treatment of premenopausal women with HSDD as it was effective in reducing the symptoms, probably due to an increase in the serum levels of free and bioavailable testosterone.

The effect of ondansetron on analgesic efficacy of acetaminophen after hysterectomy: A randomized double blinded placebo controlled trial.

PubMed

Koyuncu, Onur; Leung, Steve; You, Jing; Oksar, Menekse; Turhanoglu, Selim; Akkurt, Cagla; Dolapcioglu, Kenan; Sahin, Hanifi; Sessler, Daniel I; Turan, Alparslan

2017-08-01

To determine that perioperative ondansetron reduces the analgesic efficacy of acetaminophen. Randomized, double-blinded study. 120 patients ASA I-II who underwent abdominal hysterectomy. All the patients were given 1g acetaminophen at skin closure. Patients were divided into two groups; ondansetron HCl (8mg, 2ml IV) (Group I, N=60) and saline (2ml IV) (Group II, N=60) at the skin closure. Postoperative pain scores (VAS) while resting in bed and sitting, total opioid consumption were noted. Patients randomized to ondansetron had significantly worse pain scores upon arrival to the recovery unit [by 1.7 (99.7% CI: 0.75, 2.59) cm] and at 1h [by 1.3 (0.5, 2.1) cm] while resting in bed. Pain scores while sitting were also significantly greater in ondansetron group at arrival in PACU by 0.6 (99.7% CI: 0.1, 1.0) cm. Thereafter, pain scores did not differ significantly. Median total opioid (tramadol) consumption was 441 [Q1, Q3: 280, 578] mg in the ondansetron group and 412 [309, 574] mg in the placebo group, P=0.95. Ondansetron significantly decreased the analgesic effect of acetaminophen during the initial postoperative period. Our results thus confirm that acetaminophen analgesia is partially mediated by serotonin receptors. However, the reduction was of marginal clinical importance and short-lived. Copyright © 2017 Elsevier Inc. All rights reserved.

Radial extracorporeal shock-wave therapy in patients with chronic rotator cuff tendinitis: a prospective randomised double-blind placebo-controlled multicentre trial.

PubMed

Kolk, A; Yang, K G Auw; Tamminga, R; van der Hoeven, H

2013-11-01

The aim of this study was to determine the effect of radial extracorporeal shock-wave therapy (rESWT) on patients with chronic tendinitis of the rotator cuff. This was a randomised controlled trial in which 82 patients (mean age 47 years (24 to 67)) with chronic tendinitis diagnosed clinically were randomly allocated to a treatment group who received low-dose rESWT (three sessions at an interval 10 to 14 days, 2000 pulses, 0.11 mJ/mm(2), 8 Hz) or to a placebo group, with a follow-up of six months. The patients and the treating orthopaedic surgeon, who were both blinded to the treatment, evaluated the results. A total of 44 patients were allocated to the rESWT group and 38 patients to the placebo group. A visual analogue scale (VAS) score for pain, a Constant-Murley (CMS) score and a simple shoulder test (SST) score significantly improved in both groups at three and six months compared with baseline (all p ≤ 0.012). The mean VAS was similar in both groups at three (p = 0.43) and six months (p = 0.262). Also, the mean CMS and SST scores were similar in both groups at six months (p = 0.815 and p = 0.834, respectively). It would thus seem that low-dose rESWT does not reduce pain or improve function in patients chronic rotator cuff tendinitis compared with placebo treatment.

Learning to rank for blind image quality assessment.

PubMed

Gao, Fei; Tao, Dacheng; Gao, Xinbo; Li, Xuelong

2015-10-01

Blind image quality assessment (BIQA) aims to predict perceptual image quality scores without access to reference images. State-of-the-art BIQA methods typically require subjects to score a large number of images to train a robust model. However, subjective quality scores are imprecise, biased, and inconsistent, and it is challenging to obtain a large-scale database, or to extend existing databases, because of the inconvenience of collecting images, training the subjects, conducting subjective experiments, and realigning human quality evaluations. To combat these limitations, this paper explores and exploits preference image pairs (PIPs) such as the quality of image Ia is better than that of image Ib for training a robust BIQA model. The preference label, representing the relative quality of two images, is generally precise and consistent, and is not sensitive to image content, distortion type, or subject identity; such PIPs can be generated at a very low cost. The proposed BIQA method is one of learning to rank. We first formulate the problem of learning the mapping from the image features to the preference label as one of classification. In particular, we investigate the utilization of a multiple kernel learning algorithm based on group lasso to provide a solution. A simple but effective strategy to estimate perceptual image quality scores is then presented. Experiments show that the proposed BIQA method is highly effective and achieves a performance comparable with that of state-of-the-art BIQA algorithms. Moreover, the proposed method can be easily extended to new distortion categories.

Efficacy and safety of rotigotine in Japanese patients with restless legs syndrome: a phase 3, multicenter, randomized, placebo-controlled, double-blind, parallel-group study.

PubMed

Inoue, Yuichi; Shimizu, Tetsuo; Hirata, Koichi; Uchimura, Naohisa; Ishigooka, Jun; Oka, Yasunori; Ikeda, Junji; Tomida, Takayuki; Hattori, Nobutaka

2013-11-01

We aimed to ascertain the efficacy and safety of transdermal rotigotine (2 and 3mg/24h) in Japanese patients with restless legs syndrome (RLS). In our double-blind placebo-controlled study, 284 Japanese patients with idiopathic RLS were randomly assigned to receive rotigotine 2mg/24h or 3mg/24h, or placebo, for 13 weeks. The primary endpoint was the change in International Restless Legs Syndrome Study Group rating scale (IRLS) total score. The placebo-subtracted decreases in IRLS total score for rotigotine 2 mg/24 h and 3 mg/24 h were -2.8±1.3 and -3.1±1.3, respectively, which were significant (P<0.05). The interaction between baseline Pittsburgh Sleep Quality Index (PSQI) and treatment group for the change in IRLS total score was significant, indicating greater improvements in IRLS total score in patients with severe insomnia. Overall, 80.0%, 86.2%, and 51.6% of patients in the rotigotine 2 mg/24 h, 3 mg/24 h, and placebo groups, respectively, experienced adverse events (AEs) including application site reactions in 42.1%, 50.0%, and 7.4% of patients, respectively. None of the AEs were severe. Our results showed that rotigotine was effective without major safety concerns at doses of up to 3 mg/24 h in Japanese patients with RLS. Copyright © 2013 Elsevier B.V. All rights reserved.

Effects of far-infrared irradiation on myofascial neck pain: a randomized, double-blind, placebo-controlled pilot study.

PubMed

Lai, Chien-Hung; Leung, Ting-Kai; Peng, Chih-Wei; Chang, Kwang-Hwa; Lai, Ming-Jun; Lai, Wen-Fu; Chen, Shih-Ching

2014-02-01

The objective of this study was to determine the relative efficacy of irradiation using a device containing a far-infrared emitting ceramic powder (cFIR) for the management of chronic myofascial neck pain compared with a control treatment. This was a randomized, double-blind, placebo-controlled pilot study. The study comprised 48 patients with chronic, myofascial neck pain. Patients were randomly assigned to the experimental group or the control (sham-treatment) group. The patients in the experimental group wore a cFIR neck device for 1 week, and the control group wore an inert neck device for 1 week. Quantitative measurements based on a visual analogue scale (VAS) scoring of pain, a sleep quality assessment, pressure-pain threshold (PPT) testing, muscle tone and compliance analysis, and skin temperature analysis were obtained. Both the experimental and control groups demonstrated significant improvement in pain scores. However, no statistically significant difference in the pain scores was observed between the experimental and control groups. Significant decreases in muscle stiffness in the upper regions of the trapezius muscles were reported in the experimental group after 1 week of treatment. Short-term treatment using the cFIR neck device partly reduced muscle stiffness. Although the differences in the VAS and PPT scores for the experimental and control groups were not statistically significant, the improvement in muscle stiffness in the experimental group warrants further investigation of the long-term effects of cFIR treatment for pain management.

Development and validation of the FRAGIRE tool for assessment an older person's risk for frailty.

PubMed

Vernerey, Dewi; Anota, Amelie; Vandel, Pierre; Paget-Bailly, Sophie; Dion, Michele; Bailly, Vanessa; Bonin, Marie; Pozet, Astrid; Foubert, Audrey; Benetkiewicz, Magdalena; Manckoundia, Patrick; Bonnetain, Franck

2016-11-17

Frailty is highly prevalent in elderly people. While significant progress has been made to understand its pathogenesis process, few validated questionnaire exist to assess the multidimensional concept of frailty and to detect people frail or at risk to become frail. The objectives of this study were to construct and validate a new frailty-screening instrument named Frailty Groupe Iso-Ressource Evaluation (FRAGIRE) that accurately predicts the risk for frailty in older adults. A prospective multicenter recruitment of the elderly patients was undertaken in France. The subjects were classified into financially-helped group (FH, with financial assistance) and non-financially helped group (NFH, without any financial assistance), considering FH subjects are more frail than the NFH group and thus representing an acceptable surrogate population for frailty. Psychometric properties of the FRAGIRE grid were assessed including discrimination between the FH and NFH groups. Items reduction was made according to statistical analyses and experts' point of view. The association between items response and tests with "help requested status" was assessed in univariate and multivariate unconditional logistic regression analyses and a prognostic score to become frail was finally proposed for each subject. Between May 2013 and July 2013, 385 subjects were included: 338 (88%) in the FH group and 47 (12%) in the NFH group. The initial FRAGIRE grid included 65 items. After conducting the item selection, the final grid of the FRAGIRE was reduced to 19 items. The final grid showed fair discrimination ability to predict frailty (area under the curve (AUC) = 0.85) and good calibration (Hosmer-Lemeshow P-value = 0.580), reflecting a good agreement between the prediction by the final model and actual observation. The Cronbach's alpha for the developed tool scored as high as 0.69 (95% Confidence Interval: 0.64 to 0.74). The final prognostic score was excellent, with an AUC of 0.756. Moreover, it facilitated significant separation of patients into individuals requesting for help from others (P-value < 0.0001), with sensitivity of 81%, specificity of 61%, positive predictive value of 93%, negative predictive value of 34%, and a global predictive value of 78%. The FRAGIRE seems to have considerable potential as a reliable and effective tool for identifying frail elderly individuals by a public health social worker without medical training.

Clinical Efficacy of Intravenous Lidocaine for Thyroidectomy: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial.

PubMed

Choi, Geun Joo; Kang, Hyun; Ahn, Eun Jin; Oh, Jong In; Baek, Chong Wha; Jung, Yong Hun; Kim, Jin Yun

2016-12-01

Systemic lidocaine has analgesic and anti-inflammatory effects. The purpose of this prospective, randomized, double-blind study was to evaluate the effects of intravenous lidocaine on pain following thyroidectomy. Fifty-eight adult patients scheduled for total thyroidectomy were randomly allocated to receive a 1.5 mg/kg lidocaine bolus followed by a 2 mg/kg/h infusion during surgery, or the same volume of normal saline (control). After thyroidectomy, we evaluated postoperative pain, nausea, fentanyl consumption, frequency of pushing the button (FPB) for patient-controlled analgesia (PCA), High-sensitivity C-reactive protein (hs-CRP) in serum, and patient satisfaction scores regarding the recovery process. Postoperative pain and nausea scores were significantly lower in the lidocaine group for the first 4 h following thyroidectomy, compared to the control group. Fentanyl consumption and FPB for the PCA were also significantly reduced in the lidocaine group for 4 h following thyroidectomy, and hs-CRP was significantly less in the lidocaine group at postoperative days 1 and 3. Furthermore, satisfaction scores were significantly higher in the lidocaine group compared to the control group. Intravenous lidocaine effectively reduced postoperative pain and nausea following thyroidectomy as well as improved the quality of recovery. Clinicaltrials.gov NCT01608360.

Psychological well-being and social participation assessment in visually impaired subjects playing Torball: a controlled study.

PubMed

Di Cagno, A; Iuliano, E; Aquino, G; Fiorilli, G; Battaglia, C; Giombini, A; Calcagno, G

2013-04-01

The aim of this study was to evaluate the differences in psychological well-being, symptomatic psychological disorders and social participation, between blind Torball players and non-players. Thirty blind male participants were recruited, 17 Torball players (aged 36.27±3.46) and 13 non-players (aged 34.80±2.53), and evaluated for social participation level, psychological well-being and symptomatic psychological disorders, using three validated self-report questionnaires: Participation Scale (PS), Psychological Well-Being Scale (PWBS) and Symptom Checklist 90 R (SCL-90-R) respectively. ANOVA showed significant overall differences between the two groups. The social restriction score in the non-player group was significantly higher (p<0.01) than the player group. The Torball player group showed significant better scores than non-player group in 5 of the 6 dimensions of the PWB Scale (p<0.01) and in 8 of the 10 dimensions of the SCL-90-R (7 dimensions p<0.01; 1 dimension p<0.05) and in the three global scores of the SCL-90-R (p<0.01). The results of this study showed a relationship between psychological well-being and social skills of visually impaired people and their Torball practice. Copyright © 2012 Elsevier Ltd. All rights reserved.

Morinda citrifolia (Noni) as an Anti-Inflammatory Treatment in Women with Primary Dysmenorrhoea: A Randomised Double-Blind Placebo-Controlled Trial.

PubMed

Fletcher, H M; Dawkins, J; Rattray, C; Wharfe, G; Reid, M; Gordon-Strachan, G

2013-01-01

Introduction. Noni (Morinda citrifolia) has been used for many years as an anti-inflammatory agent. We tested the efficacy of Noni in women with dysmenorrhea. Method. We did a prospective randomized double-blind placebo-controlled trial in 100 university students of 18 years and older over three menstrual cycles. Patients were invited to participate and randomly assigned to receive 400 mg Noni capsules or placebo. They were assessed for baseline demographic variables such as age, parity, and BMI. They were also assessed before and after treatment, for pain, menstrual blood loss, and laboratory variables: ESR, hemoglobin, and packed cell volume. Results. Of the 1027 women screened, 100 eligible women were randomized. Of the women completing the study, 42 women were randomized to Noni and 38 to placebo. There were no significant differences in any of the variables at randomization. There were also no significant differences in mean bleeding score or pain score at randomization. Both bleeding and pain scores gradually improved in both groups as the women were observed over three menstrual cycles; however, the improvement was not significantly different in the Noni group when compared to the controls. Conclusion. Noni did not show a reduction in menstrual pain or bleeding when compared to placebo.

Morinda citrifolia (Noni) as an Anti-Inflammatory Treatment in Women with Primary Dysmenorrhoea: A Randomised Double-Blind Placebo-Controlled Trial

PubMed Central

Fletcher, H. M.; Dawkins, J.; Rattray, C.; Wharfe, G.; Reid, M.; Gordon-Strachan, G.

2013-01-01

Introduction. Noni (Morinda citrifolia) has been used for many years as an anti-inflammatory agent. We tested the efficacy of Noni in women with dysmenorrhea. Method. We did a prospective randomized double-blind placebo-controlled trial in 100 university students of 18 years and older over three menstrual cycles. Patients were invited to participate and randomly assigned to receive 400 mg Noni capsules or placebo. They were assessed for baseline demographic variables such as age, parity, and BMI. They were also assessed before and after treatment, for pain, menstrual blood loss, and laboratory variables: ESR, hemoglobin, and packed cell volume. Results. Of the 1027 women screened, 100 eligible women were randomized. Of the women completing the study, 42 women were randomized to Noni and 38 to placebo. There were no significant differences in any of the variables at randomization. There were also no significant differences in mean bleeding score or pain score at randomization. Both bleeding and pain scores gradually improved in both groups as the women were observed over three menstrual cycles; however, the improvement was not significantly different in the Noni group when compared to the controls. Conclusion. Noni did not show a reduction in menstrual pain or bleeding when compared to placebo. PMID:23431314

Intravenous immunoglobulin for chronic residual peripheral neuropathy in eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome): a multicenter, double-blind trial.

PubMed

Koike, Haruki; Akiyama, Kazuo; Saito, Toyokazu; Sobue, Gen

2015-03-01

Eosinophilic granulomatosis with polyangiitis (EGPA), previously called Churg-Strauss syndrome, frequently affects the peripheral nervous system. We conducted a multicenter, double-blind, three-arm treatment period, randomized, pre-post trial to assess the efficacy of intravenous immunoglobulin (IVIg) administration for residual peripheral neuropathy in patients with EGPA that is in remission, indicated by laboratory indices. Twenty-three patients were randomly assigned into three groups, in which the timing of IVIg and placebo administration was different. Each group received one course of intervention and two courses of placebo at 2-week intervals. Treatment effects were assessed every 2 weeks for 8 weeks. The primary outcome measure, the amount of change in the manual muscle testing sum score 2 weeks after IVIg administration, significantly increased (p = 0.002). The results over time suggested that this effect continued until the last assessment was done 8 weeks later. The number of muscles with manual muscle testing scores of three or less (p = 0.004) and the neuropathic pain scores represented by the visual analogue scale (p = 0.005) also improved significantly 2 weeks after IVIg administration. This study indicates that IVIg treatment for EGPA patients with residual peripheral neuropathy should be considered even when laboratory indices suggest remission of the disease.

Ibuprofen and paracetamol for pain relief during medical abortion: a double-blind randomized controlled study.

PubMed

Livshits, Anna; Machtinger, Ronit; David, Liat Ben; Spira, Maya; Moshe-Zahav, Aliza; Seidman, Daniel S

2009-05-01

To determine the efficacy of a nonsteroidal anti-inflammatory drug vs. paracetamol in pain relief during medical abortion and to evaluate whether nonsteroidal anti-inflammatory drugs interfere with the action of misoprostol. A prospective double-blind controlled study. University-affiliated tertiary hospital. One hundred twenty women who underwent first-trimester termination of pregnancy. Patients received 600 mg mifepristone orally, followed by 400 microg of oral misoprostol 2 days later. They were randomized to receive ibuprofen or paracetamol when pain relief was necessary. Patients completed a questionnaire about side effects and pain score and returned for an ultrasound follow-up examination 10-14 days after medical abortion. Success rates, as defined by no surgical intervention, and pain scores were assessed. Ibuprofen was found to be statistically significantly more effective for pain relief after medical abortion compared with paracetamol. There was no difference in the failure rate of medical abortion, and the frequency of surgical intervention was slightly higher in the group that received paracetamol (16.3% vs. 8.5%). Ibuprofen was found to be more effective than paracetamol for pain reduction during medical abortion. A history of surgical or medical abortion was predictive for high pain scores. Despite its anti-prostaglandin effects, ibuprofen use did not interfere with the action of misoprostol.

Enzyme potentiated desensitisation in treatment of seasonal allergic rhinitis: double blind randomised controlled study.

PubMed

Radcliffe, Michael J; Lewith, George T; Turner, Richard G; Prescott, Philip; Church, Martin K; Holgate, Stephen T

2003-08-02

To assess the efficacy of enzyme potentiated desensitisation in the treatment of severe summer hay fever poorly controlled by pharmacotherapy. Double blind randomised placebo controlled parallel group study. Hospital in Hampshire. 183 participants aged between 18 and 64 with a history of severe summer hay fever for at least two years; all were skin prick test positive to timothy grass pollen. 90 randomised to active treatment; 93 randomised to placebo. Active treatment: two injections of enzyme potentiated desensitisation, given between eight and 11 weeks apart, each comprising 200 Fishman units of beta glucuronidase, 50 pg 1,3-cyclohexanediol, 50 ng protamine sulphate, and a mixed inhaled allergen extract (pollen mixes for trees, grasses, and weeds; allergenic fungal spores; cat and dog danders; dust and storage mites) in a total volume of 0.05 ml of buffered saline. Placebo: two injections of 0.05 ml buffered saline solution. Proportion of problem-free days; global rhinoconjunctivitis quality of life scores assessed weekly during pollen season. The active treatment group and the placebo group did not differ in the proportion of problem-free days, quality of life scores, symptom severity scores, change in quantitative skin prick provocation threshold, or change in conjunctival provocation threshold. No clinically significant adverse reactions occurred. Enzyme potentiated desensitisation showed no treatment effect in this study.

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

PubMed

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

2014-04-01

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

Intranasal topical local anesthetic and decongestant for flexible nasendoscopy in children: a randomized, double-blind, placebo-controlled trial.

PubMed

Chadha, Neil K; Lam, Gilbert O A; Ludemann, Jeffrey P; Kozak, Frederick K

2013-12-01

To our knowledge, the present study is the first double-blind, randomized, placebo-controlled trial in children to compare nasal preparation sprays administered before flexible nasendoscopy with placebo. To compare the degree of pain experienced by children undergoing flexible nasendoscopy after 1 of 3 intranasal sprays: placebo, decongestant with topical local anesthetic (TLA), or decongestant without TLA. A randomized placebo-controlled trial with blinding of participants, caregivers, observers, and otolaryngologists was conducted in a tertiary pediatric otolaryngology ambulatory clinic. Participants included a consecutive sample of children aged 3 to 12 years requiring flexible nasendoscopy. Exclusion criteria included concomitant respiratory tract infection, known allergy to a trial agent, or previous flexible nasendoscopy. One hundred fifty-one children were assessed for eligibility; 24 eligible children refused participation and 69 were included and block-randomized. All completed the study, and there were no adverse events. Nasal spray administration of placebo (normal saline); xylometazoline hydrochloride, 0.05% (decongestant); or lidocaine hydrochloride, 1%, with xylometazoline hydrochloride, 0.05% (TLA with decongestant) was performed 10 minutes before flexible nasendoscopy. Primary outcome measure was the child-reported Wong-Baker Faces Pain (WBFP) scale. Secondary outcomes included the caregiver-proxy WBFP scale; the Face, Legs, Activity, Cry, and Consolability (FLACC) scale; and the physician-reported Difficulty of Procedure Visual Analog Scale (DPVAS). Twenty-three children were recruited in each of the intervention arms. Baseline characteristics were comparable between groups. The mean child-rated WBFP scale scores were 2.4, 1.8, and 2.2 for the placebo, decongestant, and TLA with decongestant groups, respectively (P = .45). Although the finding was statistically nonsignificant, decongestant had the lowest mean caregiver-proxy WBFP scale score, lowest observer-rated FLACC scale score, and highest physician-rated DPVAS score. Subgroup analysis did not demonstrate any correlation between the outcomes and age or sex. This study revealed no statistically significant difference in the discomfort experienced by children undergoing flexible nasendoscopy after placebo, decongestant, or TLA with decongestant. Decongestant was associated with the least discomfort (on child, caregiver, and observer-rated pain scale scores) and the lowest rating for difficulty of procedure. With these findings, the study suggests that there is no significant benefit of topical decongestant with or without TLA compared with placebo in reducing pain associated with pediatric flexible nasendoscopy. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01351298.

Pregabalin for painful HIV neuropathy

PubMed Central

Simpson, D. M.; Schifitto, G.; Clifford, D. B.; Murphy, T. K.; Durso-De Cruz, E.; Glue, P.; Whalen, E.; Emir, B.; Scott, G. N.; Freeman, R.

2010-01-01

Objective: Pregabalin is effective in several neuropathic pain syndromes. This trial evaluated its efficacy, safety, and tolerability for treatment of painful HIV-associated neuropathy. Methods: This randomized, double-blind, placebo-controlled, parallel-group trial included a 2-week double-blind dose-adjustment (150–600 mg/day BID) phase, a 12-week double-blind maintenance phase, and an optional 3-month open label extension phase. The primary efficacy measure was the mean Numeric Pain Rating Scale (NPRS) score, an 11-point numeric rating scale. Secondary measures included Patient Global Impression of Change (PGIC) and sleep measurements. Results: Baseline mean NPRS score was 6.93 for patients randomized to pregabalin (n = 151) and 6.72 for those to placebo (n = 151). Pregabalin average daily dosage (SD) was 385.7 (160.3) mg/d. At endpoint, pregabalin and placebo showed substantial reductions in mean NPRS score from baseline: −2.88 vs −2.63, p = 0.3941. Pregabalin had greater improvements in NPRS score relative to placebo at weeks 1 (−1.14 vs −0.69, p = 0.0131) and 2 (−1.92 vs −1.43, p = 0.0393), and at weeks 7 (−3.22 vs −2.53 p = 0.0307) and 8 (−3.33 vs −2.53, p = 0.0156). At all other time points, differences between groups were not significant. Sleep measurements and 7-item PGIC did not differ among treatment groups; however, collapsed PGIC scores showed 82.8% of pregabalin and 66.7% of placebo patients rated themselves in 1 of the 3 “improved” categories (p = 0.0077). Somnolence and dizziness were the most common adverse events with pregabalin. Conclusions: Pregabalin was well-tolerated, but not superior to placebo in the treatment of painful HIV neuropathy. Factors predicting analgesic response in HIV neuropathy warrant additional research. Classification of Evidence: This Class II trial showed that pregabalin is not more effective than placebo in treatment of painful HIV neuropathy. GLOSSARY AE = adverse events; ANCOVA = analysis of covariance; ARF = activity region finder; ARV = antiretroviral; GPS = Gracely Pain Scale; HADS = Hospital Anxiety and Depression Scale; HIV-DSP = HIV-associated distal sensory polyneuropathy; LOCF = last observation carried forward; mBPI-sf = modified Brief Pain Inventory–short form; NPRS = Numeric Pain Rating Scale; NPSI = Neuropathic Pain Symptom Inventory; NRS = Numeric Rating Scale; PGIC = Patient Global Impression of Change; VAS = visual analog scale. PMID:20124207

Effects of conjugated linoleic acid and high oleic acid safflower oil in the treatment of children with HPV-induced laryngeal papillomatosis: a randomized, double-blinded and crossover preliminary study.

PubMed

Louw, Louise

2012-10-12

Surgery is the mainstay therapy for HPV-induced laryngeal papillomatosis (LP) and adjuvant therapies are palliative at best. Research revealed that conjugated-linoleic acid (CLA) may improve the outcome of virally-induced diseases. The effects of Clarinol™ G-80 (CLA) and high oleic safflower oil (HOSF) on children with LP (concomitant with surgery) were evaluated. A randomized, double-blinded, crossover and reference-oil controlled trial was conducted at a South African medical university. Study components included clinical, HPV type/load and lymphocyte/cytokine analyses, according to routine laboratory methods. Overall: ten children enrolled; eight completed the trial; five remained randomized; seven received CLA first; all treatments remained double-blinded. Children (4 to 12 years) received 2.5 ml p/d CLA (8 weeks) and 2.5 ml p/d HOSF (8 weeks) with a washout period (6 weeks) in-between. The one-year trial included a post-treatment period (30 weeks) and afterwards was a one-year follow-up period. Changes in numbers of surgical procedures for improved disease outcome, total/anatomical scores (staging system) for papillomatosis prevention/viral inhibition, and lymphocyte/cytokine counts for immune responses between baselines and each treatment/end of trial were measured. After each treatment all the children were in remission (no surgical procedures); after the trial two had recurrence (surgical procedures in post-treatment period); after the follow-up period three had recurrence (several surgical procedures) and five recovered (four had no surgical procedures). Effects of CLA (and HOSF to a lesser extent) were restricted to mildly/moderately aggressive papillomatosis. Children with low total scores (seven/less) and reduced infections (three/less laryngeal sub-sites) recovered after the trial. No harmful effects were observed. The number of surgical procedures during the trial (n6/available records) was significantly lower [(p 0.03) (95% CI 1.1; 0)]. Changes in scores between baselines and CLA treatments (n8) were significantly lower: total scores [(p 0.02) (95% CI -30.00; 0.00)]; anatomical scores [(p 0.008) (95% CI -33.00: -2.00)]. Immune enhancement could not be demonstrated. These preliminary case and group findings pave the way for further research on the therapeutic potential of adjuvant CLA in the treatment of HPV-induced LP.

A novel high nitrogen nickel-free coronary stents system: evaluation in a porcine model.

PubMed

Zhang, Bin; Chen, Ming; Zheng, Bo; Wang, Xin Gang; Wang, Xi Ting; Fan, Yuan Yuan; Huo, Yong

2014-04-01

To study the safety of the novel high nitrogen nickel-free austenitic stainless steel bare metal stents (BMS) in a recognized porcine coronary model and to select a better grid structure of it. Three types of stents were randomly implanted in different coronary arteries of the same pig: 316 L stainless steel BMS (316 L-BMS) (n=12), novel high nitrogen nickel-free stents Grid A (NF-A-BMS) (n=12) and novel high nitrogen nickel-free stents Grid B (NF-B-BMS) (n=12). In total, eighteen animals underwent successful random placement of 36 oversized stents in the coronary arteries. Coronary angiography was performed after 36 d of stents implantation. Nine animals were respectively sacrificed after 14 d and 36 d for histomorphologic analysis. Quantitative coronary angiography (QCA) showed similar luminal loss (LL) in the three groups: (0.21 ± 0.17) mm for 316 L-BMS, (0.16 ± 0.12) mm for NF-A-BMS, (0.24 ± 0.15) mm for NF-B-BMS (P>0.05). Histomorphomeric analysis after 15 d and 36 d revealed that there was also no significant difference among the three groups in neointimal area (NA) with similar injury scores respectively. High magnification histomorphologic examination showed similar inflammation scores in the three groups, but NF-A-BMS group had poorer endothelialization scores compared with NF-B-BMS group, 2.00 ± 0.63 vs. 2.83 ± 0.41 (P=0.015) at 15 d, which also could be proved by the scanning electron microscope. However, the difference could not been observed at 36 d. The novel NF-BMS showed similar safety as 316 L-BMS during the short-term study. NF-B-BMS had better endothelialization than NF-A-BMS and this may owe to the specific strut units. Copyright © 2014 The Editorial Board of Biomedical and Environmental Sciences. Published by China CDC. All rights reserved.

SU-F-T-513: Dosimetric Validation of Spatially Fractionated Radiotherapy Using Gel Dosimetry

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

Papanikolaou, P; Watts, L; Kirby, N

2016-06-15

Purpose: Spatially fractionated radiation therapy, also known as GRID therapy, is used to treat large solid tumors by irradiating the target to a single dose of 10–20Gy through spatially distributed beamlets. We have investigated the use of a 3D gel for dosimetric characterization of GRID therapy. Methods: GRID therapy is an external beam analog of volumetric brachytherapy, whereby we produce a distribution of hot and cold dose columns inside the tumor volume. Such distribution can be produced with a block or by using a checker-like pattern with MLC. We have studied both types of GRID delivery. A cube shaped acrylicmore » phantom was filled with polymer gel and served as a 3D dosimeter. The phantom was scanned and the CT images were used to produce two plans in Pinnacle, one with the grid block and one with the MLC defined grid. A 6MV beam was used for the plan with a prescription of 1500cGy at dmax. The irradiated phantom was scanned in a 3T MRI scanner. Results: 3D dose maps were derived from the MR scans of the gel dosimeter and were found to be in good agreement with the predicted dose distribution from the RTP system. Gamma analysis showed a passing rate of 93% for 5% dose and 2mm DTA scoring criteria. Both relative and absolute dose profiles are in good agreement, except in the peripheral beamlets where the gel measured slightly higher dose, possibly because of the changing head scatter conditions that the RTP is not fully accounting for. Our results have also been benchmarked against ionization chamber measurements. Conclusion: We have investigated the use of a polymer gel for the 3D dosimetric characterization and evaluation of GRID therapy. Our results demonstrated that the planning system can predict fairly accurately the dose distribution for GRID type therapy.« less

Evaluation of Orientation Performance of Attention Patterns for Blind Person.

PubMed

Fujisawa, Shoichiro; Ishibashi, Tatsuki; Sato, Katsuya; Ito, Sin-Ichi; Sueda, Osamu

2017-01-01

Tactile walking surface indicators (TWSIs) are installed on footpath to support independent travel for the blind. There are two types of TWSIs, attention patterns and guiding patterns. The attention pattern is usually installed at the crosswalk entrances. The direction of the crossing can be acquired by the row of the projection of the attention pattern through the soles of the shoes. In addition, truncated domes or cones of the attention pattern were arranged in a square grid, parallel or diagonal at 45 degrees to the principal direction of travel. However, the international standard organization (ISO) allows a wide-ranging size. In this research, the direction indicating performance was compared at the same intervals for the five diameters specified by the international standard. As a result of the experiment, the diagonal array does not indicate the direction of travel, but the projection row does indicate the direction of travel in the parallel array. When the attention pattern is installed at a crosswalk entrance, a parallel array should be installed in the direction of the crossing.

Transfer of learning on a spatial memory task between the blind and sighted people.

PubMed

Akpinar, Selcuk; Popović, Stevo; Kirazci, Sadettin

2012-12-01

The purpose of this study was to analyze the effect of two different types of feedback on a spatial memory task between the blind and blindfolded-sighted participants. Participants tried to estimate the predetermined distance by using their dominant hands. Both blind and blindfolded-sighted groups were randomly divided into two feedback subgroups as "100% frequency" and "10% bandwidth". The score of the participants was given verbally to the participants as knowledge of results (KR). The target distance was set as 60 cm. Sixty acquisition trials were performed in 4 sets each including 15 repetition afterwards immediate and delayed retention tests were undertaken. Moreover, 24 hours past the delayed retention test, the participants completed 15 no-KR trials as a transfer test (target distance was 30 cm). The results of the statistical analyses revealed no significant differences for both acquisition and retention tests. However, a significant difference was found at transfer test. 100% frequency blind group performed significantly less accurate than all other groups. As a result, it can be concluded that different types of feedback have similar effect on spatial memory task used in this study. However, types of feedback can change the performance of accuracy on transferring this skill among the blind.

A Test of Tactile Concentration and Short-Term Memory.

ERIC Educational Resources Information Center

Kainthola, S. D.; Singh, T. B.

1992-01-01

Twenty students and 45 adults with visual impairments or blindness were administered a test of tactile concentration and short-term memory involving the reproduction of the order of finger stimulation using the Finger Knocking Box. Reliability and validity scores indicated encouraging results with use of the instrument. (JDD)

Single-Dose Adductor Canal Block With Local Infiltrative Analgesia Compared With Local Infiltrate Analgesia After Total Knee Arthroplasty: A Randomized, Double-Blind, Placebo-Controlled Trial.

PubMed

Nader, Antoun; Kendall, Mark C; Manning, David W; Beal, Matthew; Rahangdale, Rohit; Dekker, Robert; De Oliveira, Gildasio S; Kamenetsky, Eric; McCarthy, Robert J

A single-dose adductor canal block can provide postoperative analgesia for patients undergoing total knee arthroplasty (TKA). The purpose of this study was to assess postoperative opioid consumption after ultrasound-guided single-injection bupivacaine compared with saline adductor canal block for patients undergoing TKA. After institutional review board approval, written informed consent was obtained from patients (>18 years old) undergoing elective TKA. Subjects were randomized into 2 groups as follows: adductor canal blockade with 10 mL of bupivacaine 0.25% with epinephrine 1:300,000 or 10 mL of normal saline. All patients received a periarticular infiltration mixture intraoperatively with scheduled and patient requested oral and IV analgesics postoperatively for breakthrough pain. Personnel blinded to group allocation recorded pain scores and opioid consumption every 6 hours. Pain burden, area under the numeric rating score for pain, was calculated for 36 hours. The primary outcome was postoperative IV/IM morphine (mg morEq) consumption at 36 hours after surgery. Forty (28 women/12 men) subjects were studied. Postoperative opioid consumption was reduced in the bupivacaine 48 (39 to 61) mg morEq compared with saline 60 (49 to 85) mg morEq, difference -12 (-33 to -2) mg morEq (P = 0.03). Pain burden at rest was decreased in the bupivacaine 71 (37 to 120) score · hours compared with saline 131 (92 to 161) score · hours, difference -60 (-93 to -14) score · hours (P = 0.009). Adductor canal blockade with bupivacaine 0.25% with epinephrine 1:300,000 effectively reduces pain and opioid requirement in the postoperative period after TKA. Adductor canal blockade is an effective pain management adjunct for patients undergoing TKA.

Ultrasound-Guided Intratendinous Injections With Platelet-Rich Plasma or Autologous Whole Blood for Treatment of Proximal Hamstring Tendinopathy: A Double-Blind Randomized Controlled Trial.

PubMed

Davenport, Kathleen L; Campos, Jose Santiago; Nguyen, Joseph; Saboeiro, Gregory; Adler, Ronald S; Moley, Peter J

2015-08-01

To compare the effects of ultrasound-guided platelet-rich plasma (PRP) and whole blood (WB) injections in patients with chronic hamstring tendinopathy. In a prospective double-blind randomized controlled trial, PRP or WB was injected under ultrasound guidance into the proximal hamstring tendon in a cohort of patients with clinically suspected hamstring tendinosis. Questionnaires were administered before injection and 2, 6, and 12 weeks and 6 months after injection. Pain and function outcomes were measured via the Modified Harris Hip Score (MHHS), Hip Outcome Scores for activities of daily living (ADL) and sport-specific function, and International Hip Outcome Tool 33 (IHOT-33). Diagnostic ultrasound was used to compare preinjection and 6-month postinjection tendon appearances. The WB group showed greater improvements in pain and function over the PRP group before 12 weeks, whereas the PRP group showed improved outcomes over WB at 6 months. None of these between-group outcome measures, except 6-week IHOT-33, showed statistical significance. Comparing preinjection and 6-month scores, the PRP group showed significant improvements in ADL (P = .018) and IHOT-33 (P = .28) scores, whereas the WB group showed no significant improvements from baseline. The WB group showed significantly decreased pain with 15-minute sitting (P= .008) at 6 months. Ultrasound imaging showed no significant differences between PRP and WB group tendon appearances. Both PRP and WB groups showed improvements in all outcome measures at 6 months. The PRP group showed significant improvements in 6-month ADL and IHOT-33 scores. The WB group reached significance in 15-minute sitting pain. No significant between-group differences were observed at any time point. © 2015 by the American Institute of Ultrasound in Medicine.

Correlation of visual in vitro cytotoxicity ratings of biomaterials with quantitative in vitro cell viability measurements.

PubMed

Bhatia, Sujata K; Yetter, Ann B

2008-08-01

Medical devices and implanted biomaterials are often assessed for biological reactivity using visual scores of cell-material interactions. In such testing, biomaterials are assigned cytotoxicity ratings based on visual evidence of morphological cellular changes, including cell lysis, rounding, spreading, and proliferation. For example, ISO 10993 cytotoxicity testing of medical devices allows the use of a visual grading scale. The present study compared visual in vitro cytotoxicity ratings to quantitative in vitro cytotoxicity measurements for biomaterials to determine the level of correlation between visual scoring and a quantitative cell viability assay. Biomaterials representing a spectrum of biological reactivity levels were evaluated, including organo-tin polyvinylchloride (PVC; a known cytotoxic material), ultra-high molecular weight polyethylene (a known non-cytotoxic material), and implantable tissue adhesives. Each material was incubated in direct contact with mouse 3T3 fibroblast cell cultures for 24 h. Visual scores were assigned to the materials using a 5-point rating scale; the scorer was blinded to the material identities. Quantitative measurements of cell viability were performed using a 3-(4,5-dimethylthiozol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) colorimetric assay; again, the assay operator was blinded to material identities. The investigation revealed a high degree of correlation between visual cytotoxicity ratings and quantitative cell viability measurements; a Pearson's correlation gave a correlation coefficient of 0.90 between the visual cytotoxicity score and the percent viable cells. An equation relating the visual cytotoxicity score and the percent viable cells was derived. The results of this study are significant for the design and interpretation of in vitro cytotoxicity studies of novel biomaterials.

Comparative Evaluation of Neem Mouthwash on Plaque and Gingivitis: A Double-blind Crossover Study.

PubMed

Jalaluddin, Md; Rajasekaran, U B; Paul, Sam; Dhanya, R S; Sudeep, C B; Adarsh, V J

2017-07-01

The present study aimed at evaluating the impact of neem-containing mouthwash on plaque and gingivitis. This randomized, double-blinded, crossover clinical trial included 40 participants aged 18 to 35 years with washout period of 1 week between the crossover phases. A total of 20 participants, each randomly allocated into groups I and II, wherein in the first phase, group I was provided with 0.2% chlorhexidine gluconate and group II with 2% neem mouthwash. After the scores were recorded, 1-week time period was given to the participants to carry over the effects of the mouthwashes and then the second phase of the test was performed. The participants were instructed to use the other mouthwash through the second test phase. There was a slight reduction of plaque level in the first phase as well as in the second phase. When comparison was made between the groups, no statistically significant difference was seen. Both the groups showed reduction in the gingival index (GI) scores in the first phase, and there was a statistically significant difference in both groups at baseline and after intervention (0.005 and 0.01 respectively). In the second phase, GI scores were reduced in both groups, but there was a statistically significant difference between the groups only at baseline scores (0.01). In the present study, it has been concluded that neem mouthwash can be used as an alternative to chlorhexidine mouthwash based on the reduced scores in both the groups. Using neem mouthwash in maintaining oral hygiene might have a better impact in prevention as well as pervasiveness of oral diseases as it is cost-effective and easily available.

Efficacy and Safety of Levosulpiride Versus Haloperidol Injection in Patients With Acute Psychosis: A Randomized Double-Blind Study.

PubMed

Lavania, Sagar; Praharaj, Samir Kumar; Bains, Hariender Singh; Sinha, Vishal; Kumar, Abhinav

2016-01-01

Injectable antipsychotics are frequently required for controlling agitation and aggression in acute psychosis. No study has examined the use of injectable levosulpiride for this indication. To compare the efficacy and safety of injectable levosulpiride and haloperidol in patients with acute psychosis. This was a randomized, double-blind, parallel-group study in which 60 drug-naive patients having acute psychosis were randomly assigned to receive either intramuscular haloperidol (10-20 mg/d) or levosulpiride (25-50 mg/d) for 5 days. All patients were rated on Brief Psychiatric Rating Scale (BPRS), Overt Agitation Severity Scale (OASS), Overt Aggression Scale-Modified (OAS-M) scores, Simpson Angus Scale (SAS), and Barnes Akathisia Rating Scale (BARS). Repeated-measures ANOVA for BPRS scores showed significant effect of time (P < 0.001) and a trend toward greater reduction in scores in haloperidol group as shown by group × time interaction (P = 0.076). Repeated-measures ANOVA for OASS showed significant effect of time (P < 0.001) but no group × time interaction. Repeated-measures ANOVA for OAS-M scores showed significant effect of time (P < 0.001) and greater reduction in scores in haloperidol group as shown by group × time interaction (P = 0.032). Lorazepam requirement was much lower in haloperidol group as compared with those receiving levosulpiride (P = 0.022). Higher rates of akathisia and extrapyramidal symptoms were noted in the haloperidol group. Haloperidol was more effective than levosulpiride injection for psychotic symptoms, aggression, and severity of agitation in acute psychosis, but extrapyramidal adverse effects were less frequent with levosulpiride as compared with those receiving haloperidol.

Quality of randomized controlled trials published in the International Urogynecology Journal 2007-2016.

PubMed

Kim, Kyu Shik; Chung, Jae Hoon; Jo, Jung Ki; Kim, Jae Heon; Kim, Seungjun; Cho, Jeoung Man; Cho, Hee Ju; Choi, Hong Yong; Lee, Seung Wook

2018-07-01

Randomized controlled trials (RCTs) provide the best quality clinical evidence. The aim of this study was to assess the quality of RCTs published by the International Urogynecology Journal (IUJ) in 2007-2016. RCTs in original articles were extracted from PubMed and IUJ homepage. Change in RCT quality over time was assessed with Jadad and van Tulder scales and Cochrane Collaboration's risk of bias tool (CCRBT). Jadad scores of 3-5 or van Tulder scores of >5 indicated high-quality RCTs. The effect on RCT quality of including funding source and institutional review board (IRB) approval statements and describing the intervention was assessed. In addition, changes in RCT topics over time were assessed. Annual RCT frequencies did not change significantly (6.7-15.7%): 36.1% and 25.7% described blinding and allocation concealment, respectively. Both tended to increase between 2013 and 2016, particularly 2013 and 2014. Funding statement inclusion (39.1% overall) and intervention description (78.2% overall) tended to increase steadily. IRB statement inclusion (60.4% overall) increased significantly (p < 0.01). Jadad scores and van Tulder rose significantly until 2014 (p < 0.01). Frequencies of high-quality RCTs tended to rise. CCRBT indicated that RCTs with a low risk of bias tended to increase until 2014. However, from 2015, Jadad scores, van Tulder, and CCRBT the low risk tended to decreased. RCTs with funding and IRB approval statements had higher Jadad and van Tulder scores than unfunded RCTs (p < 0.01 and p < 0.01, respectively). Intervention description did not associate with better quality. RCT quality improved over time, but a dip in quality was observed in 2015-2016 because of decreased blinding and allocation concealment.

Dietary Soy Supplement on Fibromyalgia Symptoms: A Randomized, Double-Blind, Placebo-Controlled, Early Phase Trial

PubMed Central

Wahner-Roedler, Dietlind L.; Thompson, Jeffrey M.; Luedtke, Connie A.; King, Susan M.; Cha, Stephen S.; Elkin, Peter L.; Bruce, Barbara K.; Townsend, Cynthia O.; Bergeson, Jody R.; Eickhoff, Andrea L.; Loehrer, Laura L.; Sood, Amit; Bauer, Brent A.

2011-01-01

Most patients with fibromyalgia use complementary and alternative medicine (CAM). Properly designed controlled trials are necessary to assess the effectiveness of these practices. This study was a randomized, double-blind, placebo-controlled, early phase trial. Fifty patients seen at a fibromyalgia outpatient treatment program were randomly assigned to a daily soy or placebo (casein) shake. Outcome measures were scores of the Fibromyalgia Impact Questionnaire (FIQ) and the Center for Epidemiologic Studies Depression Scale (CES-D) at baseline and after 6 weeks of intervention. Analysis was with standard statistics based on the null hypothesis, and separation test for early phase CAM comparative trials. Twenty-eight patients completed the study. Use of standard statistics with intent-to-treat analysis showed that total FIQ scores decreased by 14% in the soy group (P = .02) and by 18% in the placebo group (P < .001). The difference in change in scores between the groups was not significant (P = .16). With the same analysis, CES-D scores decreased in the soy group by 16% (P = .004) and in the placebo group by 15% (P = .05). The change in scores was similar in the groups (P = .83). Results of statistical analysis using the separation test and intent-to-treat analysis revealed no benefit of soy compared with placebo. Shakes that contain soy and shakes that contain casein, when combined with a multidisciplinary fibromyalgia treatment program, provide a decrease in fibromyalgia symptoms. Separation between the effects of soy and casein (control) shakes did not favor the intervention. Therefore, large-sample studies using soy for patients with fibromyalgia are probably not indicated. PMID:18990724

Observing eye movements and the influence of cognition during a symbol search task: a comparison across three age groups.

PubMed

Perrin, Maxine; Robillard, Manon; Roy-Charland, Annie

2017-12-01

This study examined eye movements during a visual search task as well as cognitive abilities within three age groups. The aim was to explore scanning patterns across symbol grids and to better understand the impact of symbol location in AAC displays on speed and accuracy of symbol selection. For the study, 60 students were asked to locate a series of symbols on 16 cell grids. The EyeLink 1000 was used to measure eye movements, accuracy, and response time. Accuracy was high across all cells. Participants had faster response times, longer fixations, and more frequent fixations on symbols located in the middle of the grid. Group comparisons revealed significant differences for accuracy and reaction times. The Leiter-R was used to evaluate cognitive abilities. Sustained attention and cognitive flexibility scores predicted the participants' reaction time and accuracy in symbol selection. Findings suggest that symbol location within AAC devices and individuals' cognitive abilities influence the speed and accuracy of retrieving symbols.

On non-parametric maximum likelihood estimation of the bivariate survivor function.

PubMed

Prentice, R L

The likelihood function for the bivariate survivor function F, under independent censorship, is maximized to obtain a non-parametric maximum likelihood estimator &Fcirc;. &Fcirc; may or may not be unique depending on the configuration of singly- and doubly-censored pairs. The likelihood function can be maximized by placing all mass on the grid formed by the uncensored failure times, or half lines beyond the failure time grid, or in the upper right quadrant beyond the grid. By accumulating the mass along lines (or regions) where the likelihood is flat, one obtains a partially maximized likelihood as a function of parameters that can be uniquely estimated. The score equations corresponding to these point mass parameters are derived, using a Lagrange multiplier technique to ensure unit total mass, and a modified Newton procedure is used to calculate the parameter estimates in some limited simulation studies. Some considerations for the further development of non-parametric bivariate survivor function estimators are briefly described.

The efficacy and tolerability of 5-aminolevulinic acid 5% thermosetting gel photodynamic therapy (PDT) in the treatment of mild-to-moderate acne vulgaris. A two-center, prospective assessor-blinded, proof-of-concept study.

PubMed

Serini, Stefano Maria; Cannizzaro, Maria Vittoria; Dattola, Annunziata; Garofalo, Virginia; Del Duca, Esther; Ventura, Alessandra; Milani, Massimo; Campione, Elena; Bianchi, Luca

2018-05-22

Acne vulgaris is a chronic inflammatory skin disease, commonly treated with topical or systemic drugs, according to the severity of the condition. Retinoids and antibiotic compounds are considered cornerstone approaches in this condition. However, low adherence to the therapy and the issue of bacterial resistance undermine the efficacy in the long term. Photodynamic therapy (PDT) with 20% aminolevulinic acid (ALA) has shown to be effective in the treatment of inflammatory acne. Skin tolerability, however, could be a limiting factor for a widespread use of this approach. A new formulation of 5% ALA in thermosetting gel has been recently available. This formulation allows a more convenient application procedure without occlusion and better and more efficient release of the active compound in comparison with traditional ALA formulations like creams or ointments. To evaluate in a two-center, assessor-blinded, prospective, proof-of-concept study, the efficacy, and tolerability of red-light (630 nm) PDT with a new 5-ALA "low-dose" topical gel formulation (5%) in the treatment of inflammatory mild-to-moderate acne vulgaris (AV). A total of 35 subjects with moderate AV of the face (mean age: 24 ± 8 years, 13 men and 22 women) were enrolled, after their written informed consent. The primary outcome was the evolution of GAG (Global Acne Grade System) score at baseline and after an average of three, 630-nm, 15-minute, PDT sessions, performed every 2 weeks. GAG score was also calculated in a follow-up visit 6 months after the last PDT session. Skin tolerability was assessed during PDT sessions with a patient-reported discomfort level evaluation score from 0 (no discomfort at all) to 3 (severe discomfort). At baseline, the GAG score was 21 ± 6. After the last PDT session, the GAG score evaluated in a blinded fashion (digital photographs) was significantly reduced to 6.5 ± 5.7, representing a 70% reduction (P = .0001, Wilcoxon test; mean difference 14.9; 95% CI of the difference: 12.1-17.6). At the follow-up visit, the GAG score was 6.7 ± 6.8. The 5% ALA thermosetting gel Red-light PDT was in general very well tolerated with a discomfort mean level score of 0.5 ± 1. This proof-of-concept study supports the efficacy of 5% ALA thermosetting gel red-light PDT in inflammatory acne of the face with a relevant clinical improvement of inflammatory lesions with a very good tolerability profile. Clinical improvement was maintained in the medium term (Trial Registration Number: ISRCTN66066651). © 2018 Wiley Periodicals, Inc.

pyDockWEB: a web server for rigid-body protein-protein docking using electrostatics and desolvation scoring.

PubMed

Jiménez-García, Brian; Pons, Carles; Fernández-Recio, Juan

2013-07-01

pyDockWEB is a web server for the rigid-body docking prediction of protein-protein complex structures using a new version of the pyDock scoring algorithm. We use here a new custom parallel FTDock implementation, with adjusted grid size for optimal FFT calculations, and a new version of pyDock, which dramatically speeds up calculations while keeping the same predictive accuracy. Given the 3D coordinates of two interacting proteins, pyDockWEB returns the best docking orientations as scored mainly by electrostatics and desolvation energy. The server does not require registration by the user and is freely accessible for academics at http://life.bsc.es/servlet/pydock. Supplementary data are available at Bioinformatics online.

Automatic measurement of skin textures of the dorsal hand in evaluating skin aging.

PubMed

Gao, Qian; Yu, Jiaming; Wang, Fang; Ge, Tiantian; Hu, Liwen; Liu, Yang

2013-05-01

Changes in skin textures have been used to evaluate skin aging in many studies. In our previous study, we built some skin texture parameters, which can be used to evaluate skin aging of human dorsal hand. However, it will take too much time and need to work arduously to get the information from digital skin image by manual work. So, we want to build a simple and effective method to automatically count some of those skin texture parameters by using digital image-processing technology. A total of 100 subjects aged 30 years and above were involved. Sun exposure history and demographic information were collected by using a questionnaire. The skin image of subjects' dorsal hand was obtained by using a portable skin detector. The number of grids, which is one of skin texture parameters built in our previous study, was measured manually and automatically. Automated image analysis program was developed by using Matlab 7.1 software. The number of grids counted automatically (NGA) was significantly correlated with the number of grids counted manually (NGM) (r = 0.9287, P < 0.0001). And in each age group, there were no significant differences between NGA and NGM. The NGA was negatively correlated with age and lifetime sun exposure, and decreased with increasing Beagley-Gibson score from 3 to 6. In addition, even after adjusting for NGA, the standard deviation of grid areas for each image was positively correlated with age, sun exposure, and Bealey-Gibson score. The method introduced in present study can be used to measure some skin aging parameters automatically and objectively. And it will save much time, reduce labor, and avoid measurement errors of deferent investigators when evaluating a great deal of skin images in a short time. © 2013 John Wiley & Sons A/S. Published by Blackwell Publishing Ltd.

Psychological stress measurement through voice output analysis

NASA Technical Reports Server (NTRS)

Older, H. J.; Jenney, L. L.

1975-01-01

Audio tape recordings of selected Skylab communications were processed by a psychological stress evaluator. Strip chart tracings were read blind and scores were assigned based on characteristics reported by the manufacturer to indicate psychological stress. These scores were analyzed for their empirical relationships with operational variables in Skylab judged to represent varying degrees of situational stress. Although some statistically significant relationships were found, the technique was not judged to be sufficiently predictive to warrant its use in assessing the degree of psychological stress of crew members in future space missions.

Efficacy and safety of milnacipran 100 mg/day in patients with fibromyalgia: results of a randomized, double-blind, placebo-controlled trial.

PubMed

Arnold, Lesley M; Gendreau, R Michael; Palmer, Robert H; Gendreau, Judy F; Wang, Yong

2010-09-01

To assess the efficacy and safety of milnacipran at a dosage of 100 mg/day (50 mg twice daily) for monotherapy treatment of fibromyalgia. A double-blind, placebo-controlled trial was performed to assess 1,025 patients with fibromyalgia who were randomized to receive milnacipran 100 mg/day (n = 516) or placebo (n = 509). Patients underwent 4-6 weeks of flexible dose escalation followed by 12 weeks of stable-dose treatment. Two composite responder definitions were used as primary end points to classify the response to treatment. The 2-measure composite response required achievement of ≥30% improvement from baseline in the pain score and a rating of "very much improved" or "much improved" on the Patient's Global Impression of Change (PGIC) scale. The 3-measure composite response required satisfaction of these same 2 improvement criteria for pain and global status as well as improvement in physical function on the Short Form 36 (SF-36) physical component summary (PCS) score. After 12 weeks of stable-dose treatment, a significantly greater proportion of milnacipran-treated patients compared with placebo-treated patients showed clinically meaningful improvements, as evidenced by the proportion of patients meeting the 2-measure composite responder criteria (P < 0.001 in the baseline observation carried forward [BOCF] analysis) and 3-measure composite responder criteria (P < 0.001 in the BOCF). Milnacipran-treated patients also demonstrated significantly greater improvements from baseline on multiple secondary outcomes, including 24-hour and weekly recall pain score, PGIC score, SF-36 PCS and mental component summary scores, average pain severity score on the Brief Pain Inventory, Fibromyalgia Impact Questionnaire total score (all P < 0.001 versus placebo), and Multidimensional Fatigue Inventory total score (P = 0.036 versus placebo). Milnacipran was well tolerated by most patients, with nausea being the most commonly reported adverse event (placebo-adjusted rate of 15.8%). Milnacipran administered at a dosage of 100 mg/day improved pain, global status, fatigue, and physical and mental function in patients with fibromyalgia.

The Relationship Between the Learning Style Perceptual Preferences of Urban Fourth Grade Children and the Acquisition of Selected Physical Science Concepts Through Learning Cycle Instructional Methodology.

NASA Astrophysics Data System (ADS)

Adams, Kenneth Mark

The purpose of this research was to investigate the relationship between the learning style perceptual preferences of fourth grade urban students and the attainment of selected physical science concepts for three simple machines as taught using learning cycle methodology. The sample included all fourth grade children from one urban elementary school (N = 91). The research design followed a quasi-experimental format with a single group, equivalent teacher demonstration and student investigation materials, and identical learning cycle instructional treatment. All subjects completed the Understanding Simple Machines Test (USMT) prior to instructional treatment, and at the conclusion of treatment to measure student concept attainment related to the pendulum, the lever and fulcrum, and the inclined plane. USMT pre and post-test scores, California Achievement Test (CAT-5) percentile scores, and Learning Style Inventory (LSI) standard scores for four perceptual elements for each subject were held in a double blind until completion of the USMT post-test. The hypothesis tested in this study was: Learning style perceptual preferences of fourth grade students as measured by the Dunn, Dunn, and Price Learning Style Inventory (LSI) are significant predictors of success in the acquisition of physical science concepts taught through use of the learning cycle. Analysis of pre and post USMT scores, 18.18 and 30.20 respectively, yielded a significant mean gain of +12.02. A controlled stepwise regression was employed to identify significant predictors of success on the USMT post-test from among USMT pre-test, four CAT-5 percentile scores, and four LSI perceptual standard scores. The CAT -5 Total Math and Total Reading accounted for 64.06% of the variance in the USMT post-test score. The only perceptual element to act as a significant predictor was the Kinesthetic standard score, accounting for 1.72% of the variance. The study revealed that learning cycle instruction does not appear to be sensitive to different perceptual preferences. Students with different preferences for auditory, visual, and tactile modalities, when learning, seem to benefit equally from learning cycle exposure. Increased use of a double blind for future learning styles research was recommended.

Comparing Correlations between Four-Quadrant and Five-Factor Personality Assessments

ERIC Educational Resources Information Center

Jones, Cathleen S.; Hartley, Nell T.

2013-01-01

For decades,some of the most popular devices used in educating students and employees to the values of diversity are those that are based on a four-grid identification of behavior style. The results from the scoring of the instruments provide individual profiles in terms of a person's assertiveness, responsiveness, and preferred tone of…

M16. Valbenazine (NBI-98854) for the Treatment of Tardive Dyskinesia: Analysis by Underlying Psychiatric Diagnosis in Phase III KINECT 3 Study

PubMed Central

Josiassen, Richard; Kane, John; Burke, Joshua; Jimenez, Roland; Siegert, Scott; Liang, Grace

2017-01-01

Abstract Background: Valbenazine is a novel and highly selective vesicular monoamine transporter 2 (VMAT2) inhibitor that is being evaluated for the treatment of tardive dyskinesia (TD), a persistent movement disorder resulting from exposure to antipsychotics or other dopamine receptor blocking agents (DRBAs). The efficacy of valbenazine in treating TD was demonstrated in a Phase 3 clinical trial (KINECT 3; NCT02274558), which included subjects with underlying schizophrenia/schizoaffective disorder or mood disorder. Further analyses of data from that trial were conducted to explore the efficacy of valbenazine across diagnostic subgroups. Methods: Subjects in this 6-week, double-blind, placebo-controlled trial were randomized 1:1:1 to once-daily valbenazine 80 mg, valbenazine 40 mg, or placebo. The primary endpoint was change from baseline to Week 6 on the Abnormal Involuntary Movement Scale (AIMS) total score (items 1–7) for valbenazine 80 mg vs placebo in the intent-to-treat (ITT) population. AIMs were videotaped and ratings were conducted by central raters blind to study visit and group. Additional outcomes included AIMS total score change (40 mg vs placebo) and Clinical Global Impression of Change-Tardive Dyskinesia (CGI TD) score (80 and 40 mg vs placebo) at Week 6. In addition to being evaluated in the ITT population, these outcomes were analyzed in subgroups categorized by underlying psychiatric diagnosis (schizophrenia/schizoaffective disorder or mood disorder). Results: At Week 6 in the ITT population (N = 225), AIMS score improvement was significantly greater with valbenazine 80 mg than placebo (least squares [LS] mean change from baseline: 80 mg, 3.2; placebo, −0.1; P < .0001). AIMS score change at Week 6 for valbenazine 40 mg (1.9) was also greater than placebo (P = .0021). Statistical testing was not conducted in the subgroups, but the magnitude of AIMS improvement in these patients was comparable to results in the overall ITT population: schizophrenia/schizoaffective disorder (n = 148; mean change from baseline: 80 mg, −3.1; 40 mg, −1.5; placebo, +0.4); mood disorder (n = 77; 80 mg, 3.6; 40 mg, −2.5; placebo, −0.7). CGI-TD scores at Week 6 in the ITT population indicated greater global improvement with valbenazine than placebo, but between-group differences were not statistically significant (LS mean scores: 80 mg, 2.9; 40 mg, 2.9; placebo, 3.2). CGI-TD outcomes in the subgroups were as follows: schizophrenia/schizoaffective disorder (mean scores: 80 mg, 3.0; 40 mg, 2.9; placebo, 3.1); mood disorder (80 mg, 2.7; 40 mg, 2.9; placebo, 3.2). Psychiatric status remained stable during the 6-week double-blind treatment period. Conclusion: Once-daily treatment with valbenazine improved TD regardless of underlying psychiatric diagnosis.

Constitutively reduced sensory capacity promotes better recovery after spinal cord-injury (SCI) in blind rats of the dystrophic RCS strain.

PubMed

Rink, Svenja; Bendella, Habib; Alsolivany, Kurdin; Meyer, Carolin; Woehler, Aliona; Jansen, Ramona; Isik, Zeynep; Stein, Gregor; Wennmachers, Sina; Nakamura, Makoto; Angelov, Doychin N

2018-01-01

We compared functional, electrophysiological and morphological parameters after SCI in two groups of rats Sprague Dawley (SD) rats with normal vision and blind rats from a SD-substrain "Royal College of Surgeons" (SD/RCS) who lose their photoreceptor cells after birth due to a genetic defect in the retinal pigment epithelium. For these animals skin-, intramuscular-, and tendon receptors are major available means to resolve spatial information. The purpose of this study was to check whether increased sensitivity in SD/RCS rats would promote an improved recovery after SCI. All rats were subjected to severe compression of the spinal cord at vertebra Th8, spinal cord segment Th10. Recovery of locomotion was analyzed at 1, 3, 6, 9, and 12 weeks after SCI using video recordings of beam walking and inclined ladder climbing. Five functional parameters were studied: foot-stepping angle (FSA), rump-height index (RHI) estimating paw placement and body weight support, respectively, number of correct ladder steps (CLS) assessing skilled hindlimb movements, the BBB-locomotor score and an established urinary bladder score (BS). Sensitivity tests were followed by electrophysiological measurement of M- and H-wave amplitudes from contractions of the plantar musculature after stimulation of the tibial nerve. The closing morphological measurements included lesion volume and expression of astro- and microglia below the lesion. Numerical assessments of BBB, FSA, BS, lesion volume and GFAP-expression revealed no significant differences between both strains. However, compared to SD-rats, the blind SD/RCS animals significantly improved RHI and CLS by 6 - 12 weeks after SCI. To our surprise the withdrawal latencies in the blind SD/RCS rats were longer and the amplitudes of M- and H-waves lower. The expression of IBA1-immunoreactivity in the lumbar enlargement was lower than in the SD-animals. The longer withdrawal latencies suggest a decreased sensitivity in the blind SD/RCS rats, which promotes better recovery after SCI. In this way our results provide indirect support to earlier work showing, that hypersensitivity and chronic pain after contusive SCI impair the recovery of locomotor function.

Palonosetron and Hydroxyzine Pre-treatment Reduces the Objective Signs of Experimentally-Induced Acute Opioid Withdrawal in Humans: A Double-Blinded, Randomized, Placebo-Controlled Crossover Study

PubMed Central

Erlendson, Matthew; D'Arcy, Nicole; Encisco, Ellen; Yu, Jeff; Rincon-Cruz, Lorena; Peltz, Gary; Clark, J. David

2017-01-01

Background Treatments for reducing opioid withdrawal are limited and prone to problematic side effects. Laboratory studies, clinical observations, and limited human trial data suggest 5-HT3-receptor antagonists and antihistamines may be effective. Objectives This double-blind, crossover, placebo-controlled study employing an acute physical dependence model evaluated whether (i) treatment with a 5-HT3-receptor antagonist (palonosetron) would reduce opioid withdrawal symptoms, and (ii) co-administration of an antihistamine (hydroxyzine) would enhance any treatment effect. Methods At timepoint T=0, healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either a) placebo, b) palonosetron IV (0.75 mg), or c) palonosetron IV (0.75 mg) and hydroxyzine PO (100 mg) in a crossover study design. This was followed at T=30 by intravenous morphine (10mg/70kg). At T=165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T=170, 180, respectively). Baseline measurements were recorded at T=-30 and T=-15. Results Comparison of average baseline OOWS scores with OOWS scores obtained fifteen minutes after naloxone was significant (p=0.0001). Scores from fifteen minutes post-naloxone infusion showed significant differences in OOWS scores between treatment groups: placebo, 3.7 ± 2.4; palonosetron, 1.5± 0.97; and palonosetron with hydroxyzine, 0.2 ± .1333. Conclusions Pretreatment with palonosetron significantly reduced many signs of experimental-induced opioid withdrawal. Co-administration with hydroxyzine further reduced opioid withdrawal severity. These results suggest that 5-HT3 receptor antagonists, alone or in combination with an antihistamine, may be useful in the treatment of opioid withdrawal. PMID:27712113

Safety and efficacy of pregabalin in adolescents with fibromyalgia: a randomized, double-blind, placebo-controlled trial and a 6-month open-label extension study.

PubMed

Arnold, Lesley M; Schikler, Kenneth N; Bateman, Lucinda; Khan, Tahira; Pauer, Lynne; Bhadra-Brown, Pritha; Clair, Andrew; Chew, Marci L; Scavone, Joseph

2016-07-30

Fibromyalgia (FM) is a common pain condition characterized by widespread musculoskeletal pain and tenderness. Pregabalin is an approved treatment for adults in the United States, but there are no approved treatments for adolescents with FM. This was a 15-week, randomized, double-blind, placebo-controlled study and 6-month open-label safety trial of flexible-dose pregabalin (75-450 mg/day) for the treatment of adolescents (12-17 years) with FM. Primary outcome was change in mean pain score at endpoint (scored from 0-10, with 24-h recall). Secondary outcomes included global assessments and measures of pain, sleep, and FM impact. A total of 107 subjects were randomized to treatment (54 pregabalin, 53 placebo) and 80 completed the study (44 pregabalin, 36 placebo). Improvement in mean pain score at endpoint with pregabalin versus placebo was not statistically significant, treatment difference (95 % CI), -0.66 (-1.51, 0.18), P = 0.121. There were significant improvements with pregabalin versus placebo in secondary outcomes of change in pain score by week (P < 0.05 for 10 of 15 weeks); change in pain score at week 15 (1-week recall), treatment difference (95 % CI), -0.87 (-1.68, -0.05), P = 0.037; and patient global impression of change, 53.1 % versus 29.5 % very much or much improved (P = 0.013). Trends toward improvement with pregabalin in other secondary outcomes measuring pain, sleep, and FM impact were not significant. Safety was consistent with the known profile of pregabalin in adults with FM. Pregabalin did not significantly improve the mean pain score in adolescents with FM. There were significant improvements in secondary outcomes measuring pain and impression of change. NCT01020474 ; NCT01020526 .

Randomized controlled trial comparing esophageal dilation to no dilation among adults with esophageal eosinophilia and dysphagia.

PubMed

Kavitt, R T; Ates, F; Slaughter, J C; Higginbotham, T; Shepherd, B D; Sumner, E L; Vaezi, M F

2016-11-01

The role of esophageal dilation in patients with esophageal eosinophilia with dysphagia remains unknown. The practice of dilation is currently based on center preferences and expert opinion. The aim of this study is to determine if, and to what extent, dysphagia improves in response to initial esophageal dilation followed by standard medical therapies. We conducted a randomized, blinded, controlled trial evaluating adult patients with dysphagia and newly diagnosed esophageal eosinophilia from 2008 to 2013. Patients were randomized to dilation or no dilation at time of endoscopy and blinded to dilation status. Endoscopic features were graded as major and minor. Subsequent to randomization and endoscopy, all patients received fluticasone and dexlansoprazole for 2 months. The primary study outcome was reduction in overall dysphagia score, assessed at 30 and 60 days post-intervention. Patients with severe strictures (less than 7-mm esophageal diameter) were excluded from the study. Thirty-one patients were randomized and completed the protocol: 17 randomized to dilation and 14 to no dilation. Both groups were similar with regard to gender, age, eosinophil density, endoscopic score, and baseline dysphagia score. The population exhibited moderate to severe dysphagia and moderate esophageal stricturing at baseline. Overall, there was a significant (P < 0.001) but similar reduction in mean dysphagia score at 30 and 60 days post-randomization compared with baseline in both groups. No significant difference in dysphagia scores between treatment groups after 30 (P = 0.93) or 60 (P = 0.21) days post-intervention was observed. Esophageal dilation did not result in additional improvement in dysphagia score compared with treatment with proton pump inhibitor and fluticasone alone. In patients with symptomatic esophageal eosinophilia without severe stricture, dilation does not appear to be a necessary initial treatment strategy. © 2015 International Society for Diseases of the Esophagus.

The effect of non-weight bearing group-exercising on females with non-specific chronic low back pain: a randomized single blind controlled pilot study.

PubMed

Masharawi, Youssef; Nadaf, Nedal

2013-01-01

The aim of this study was to investigate the effect of active non-weight-bearing (NWB) group exercising on women with non specific chronic low back pain (NSCLBP). Forty females with NSCLBP were assigned in a randomized control longitudinal single blinded pilot study. 20 of them were assigned to a NWB bi-weekly group exercise class and 20 females were included in the control group. The exercises involved the entire lumbo-pelvic spine aimed at improving lumbar mobility/flexibility and stability. Pain intensity (VAS), back specific disability (Rolland Morris questionnaire-RMQ), and lumbar flexion and extension ranges of motion measurements were taken prior to intervention (t(0)), immediately following 4 weeks of intervention (t(1)) and 8 weeks later (t(fu)). Reliability trials were conducted on 10 females. Non-parametric tests were used for statistical significance (p < 0.05). The following significant changes in outcome measures were indicated at t(1) compared with t(0) and control group (p < 0.001): an increase in lumbar flexion and extension (mean difference = 9.26◦ (+54%) for flexion and 5.95◦ for extension(+98%)); reduction in VAS score (mean difference = 2.32 (+58%)) and RMQ score (mean difference = 4.9 (−34%)). All changes remained significant at t(fu). At t(0), lumbar flexion was correlated with extension (r = 0.547) and VAS (r = −0.581),whereas the RMQ score correlated with VAS score (r = 0.599) and negatively with lumbar extension (r = −0.665). At t(1),lumbar flexion correlated with extension (r = 0.664) and negatively with RMQ score (r = −0.54). At t(fu), changes in VAS score were negatively correlated with changes in lumbar flexion (r = −0.522), while changes in lumbar flexion correlated with extension (r = 0.58). A functional program of NWB group exercising improves functional, painful status, lumbar flexion and extension ranges of motion in women suffering from NSCLBP.

Functional outcomes from a head-to-head, randomized, double-blind trial of lisdexamfetamine dimesylate and atomoxetine in children and adolescents with attention-deficit/hyperactivity disorder and an inadequate response to methylphenidate.

PubMed

Nagy, Peter; Häge, Alexander; Coghill, David R; Caballero, Beatriz; Adeyi, Ben; Anderson, Colleen S; Sikirica, Vanja; Cardo, Esther

2016-02-01

Attention-deficit/hyperactivity disorder (ADHD) is associated with functional impairments in multiple domains of patients' lives. A secondary objective of this randomized, active-controlled, head-to-head, double-blind, dose-optimized clinical trial was to compare the effects of lisdexamfetamine dimesylate (LDX) and atomoxetine (ATX) on functional impairment in children and adolescents with ADHD. Patients aged 6-17 years with an ADHD Rating Scale IV total score ≥ 28 and an inadequate response to methylphenidate treatment (judged by investigators) were randomized (1:1) to once-daily LDX or ATX for 9 weeks. Parents/guardians completed the Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P) at baseline and at week 9 or early termination. p values were nominal and not corrected for multiple comparisons. Of 267 randomized patients, 200 completed the study (LDX 99, ATX 101). At baseline, mean WFIRS-P total score in the LDX group was 0.95 [standard deviation (SD) 0.474; 95% confidence interval (CI) 0.87, 1.03] and in the ATX group was 0.91 (0.513; 0.82, 1.00). Scores in all WFIRS-P domains improved from baseline to endpoint in both groups, with least-squares mean changes in total score of -0.35 (95% CI -0.42, -0.29) for LDX and -0.27 (-0.33, -0.20) for ATX. The difference between LDX and ATX was statistically significant (p < 0.05) for the Learning and School (effect size of LDX vs ATX, 0.43) and Social Activities (0.34) domains and for total score (0.27). Both treatments reduced functional impairment in children and adolescents with ADHD; LDX was statistically significantly more effective than ATX in two of six domains and in total score.

Theobromine for the treatment of persistent cough: a randomised, multicentre, double-blind, placebo-controlled clinical trial

PubMed Central

McGarvey, Lorcan; Pavord, Ian D.; Higgins, Bernard; Chung, Kian Fan; Birring, Surinder S.

2017-01-01

Background To investigate the effect of BC1036 on health-related quality of life (QOL) in subjects with persistent cough. The secondary objective was to investigate the effect of BC1036 on subjective cough severity. Methods This was a randomised, multicentre, double-blind, placebo-controlled, parallel-group study in 289 subjects with persistent cough. Subjects received BC1036 or placebo twice daily for 14 days. The primary endpoint comprised cough-related QOL assessed using the validated Leicester Cough Questionnaire (LCQ) at Day 14. Secondary endpoints comprised the LCQ scores at Day 7 and Day 28, cough severity VAS scores at each visit and pulmonary function tests. Results At baseline, mean total LCQ score in the BC1036 group was lower (i.e., worse QOL) than placebo (P<0.001), indicating significant between-group heterogeneity. Mean baseline-adjusted change in LCQ score at Day 14 was greater for BC1036 [mean (SD) 2.4±3.5] compared to placebo [mean (SD) score 2.2±3.0], but did not reach statistical significance (P=0.60). Mean cough severity VAS score decreased to a greater extent in the BC1036 group compared to placebo, but again the results were not statistically significant (−12.2±23.28 in BC1036 group and −11.0±21.34 in placebo group at Day 14, P=0.688). There was no significant change in pulmonary function measurements. The adverse event (AE) profile was similar in both groups. Conclusions This study showed that BC1036 was well tolerated and, although the primary endpoint did not achieve statistical significance, the magnitude of improvement was greater with BC1036 compared to placebo with respect to improving QOL and reducing cough severity. Clinical trial registration ClinicalTrials.gov: NCT01656668. PMID:28839984

Effectiveness of teaching automated external defibrillators use using a traditional classroom instruction versus self-instruction video in non-critical care nurses.

PubMed

Saiboon, Ismail M; Qamruddin, Reza M; Jaafar, Johar M; Bakar, Afliza A; Hamzah, Faizal A; Eng, Ho S; Robertson, Colin E

2016-04-01

To evaluate the effectiveness and retention of learning automated external defibrillator (AED) usage taught through a traditional classroom instruction (TCI) method versus a novel self instructed video (SIV) technique in non-critical care nurses (NCCN). A prospective single-blind randomized study was conducted over 7 months (April-October 2014) at the Universiti Kebangsaan Malaysia Medical Center, Kuala Lampur, Malaysia. Eighty nurses were randomized into either TCI or SIV instructional techniques. We assessed knowledge, skill and confidence level at baseline, immediate and 6-months post-intervention. Knowledge and confidence were assessed via questionnaire; skill was assessed by a calibrated and blinded independent assessor using an objective structured clinical examination (OSCE) method. Pre-test mean scores for knowledge in the TCI group was 10.87 ± 2.34, and for the SIV group was 10.37 ± 1.85 (maximum achievable score 20.00); 4.05 ± 2.87 in the TCI and 3.71 ± 2.66 in the SIV (maximum score 11.00) in the OSCE evaluation and 9.54 ± 3.65 in the TCI and 8.56 ± 3.47 in the SIV (maximum score 25.00) in the individual's personal confidence level. Both methods increased the mean scores significantly during immediate post-intervention (0-month). At 6-months, the TCI group scored lower than the SIV group in all aspects 11.13 ± 2.70 versus 12.95 ± 2.26 (p=0.03) in knowledge, 7.27 ± 1.62 versus 7.68 ± 1.73 (p=0.47) in the OSCE, and 16.40 ± 2.72 versus 18.82 ± 3.40 (p=0.03) in confidence level. In NCCN's, SIV is as good as TCI in providing the knowledge, competency, and confidence in performing AED defibrillation.

Effectiveness of teaching automated external defibrillators use using a traditional classroom instruction versus self-instruction video in non-critical care nurses

PubMed Central

Saiboon, Ismail M.; Qamruddin, Reza M.; BAO, MBBch; Jaafar, Johar M.; Bakar, Afliza A.; Hamzah, Faizal A.; Eng, Ho S.; Robertson, Colin E.

2016-01-01

Objectives: To evaluate the effectiveness and retention of learning automated external defibrillator (AED) usage taught through a traditional classroom instruction (TCI) method versus a novel self instructed video (SIV) technique in non-critical care nurses (NCCN). Methods: A prospective single-blind randomized study was conducted over 7 months (April-October 2014) at the Universiti Kebangsaan Malaysia Medical Center, Kuala Lampur, Malaysia. Eighty nurses were randomized into either TCI or SIV instructional techniques. We assessed knowledge, skill and confidence level at baseline, immediate and 6-months post-intervention. Knowledge and confidence were assessed via questionnaire; skill was assessed by a calibrated and blinded independent assessor using an objective structured clinical examination (OSCE) method. Results: Pre-test mean scores for knowledge in the TCI group was 10.87 ± 2.34, and for the SIV group was 10.37 ± 1.85 (maximum achievable score 20.00); 4.05 ± 2.87 in the TCI and 3.71 ± 2.66 in the SIV (maximum score 11.00) in the OSCE evaluation and 9.54 ± 3.65 in the TCI and 8.56 ± 3.47 in the SIV (maximum score 25.00) in the individual’s personal confidence level. Both methods increased the mean scores significantly during immediate post-intervention (0-month). At 6-months, the TCI group scored lower than the SIV group in all aspects 11.13 ± 2.70 versus 12.95 ± 2.26 (p=0.03) in knowledge, 7.27 ± 1.62 versus 7.68 ± 1.73 (p=0.47) in the OSCE, and 16.40 ± 2.72 versus 18.82 ± 3.40 (p=0.03) in confidence level. Conclusion: In NCCN’s, SIV is as good as TCI in providing the knowledge, competency, and confidence in performing AED defibrillation. PMID:27052286

12 CFR Appendix D-2 to Part 208 - Interagency Guidelines Establishing Information Security Standards

Code of Federal Regulations, 2014 CFR

2014-01-01

.... Design its information security program to control the identified risks, commensurate with the... Directors B. Assess Risk C. Manage and Control Risk D. Oversee Service Provider Arrangements E. Adjust the... score, derived from a group of consumer reports; or (B) Blind data, such as payment history on accounts...

12 CFR Appendix D-2 to Part 208 - Interagency Guidelines Establishing Information Security Standards

Code of Federal Regulations, 2011 CFR

2011-01-01

.... Design its information security program to control the identified risks, commensurate with the... Directors B. Assess Risk C. Manage and Control Risk D. Oversee Service Provider Arrangements E. Adjust the... score, derived from a group of consumer reports; or (B) Blind data, such as payment history on accounts...

Term Paper Quality of Online vs. Traditional Students

ERIC Educational Resources Information Center

Hayward, Stephen; Pjesky, Rex

2012-01-01

This paper uses a blind grading process to test if the performance of online students were different from traditional students using a term paper from an economics graduate course. Consistent with the literature, no significant difference was found between the scores of online students and those of traditional students. Also consistent with the…

Retinoblastoma and Superior Verbal IQ Scores?

ERIC Educational Resources Information Center

Tobin, Michael; Hill, Eileen; Hill, John

2010-01-01

Experienced teachers have long asserted that children blind from retinoblastoma (Rb), a rare cancer of the eye, are of above average intelligence. To test this hypothesis, standardized verbal intelligence tests were administered to a sample of 85 children and adults, all diagnosed with the early infancy form of this condition. For 42 of the Rb…

A semi-blinded study comparing 2 methods of measuring nasal potential difference: Subcutaneous needle versus dermal abrasion.

PubMed

De Wachter, E; De Schutter, I; Meulemans, A; Buyl, R; Malfroot, A

2016-01-01

According to European and US protocols, two nasal potential difference (NPD) measurement methods are considered acceptable, although they have not been formally compared: subcutaneous agar-filled needle with calomel (Ndl) and dermal abrasion with conducting cream and Ag/AgCl electrodes (Abr). We compared both in CF and healthy volunteers (HV), assessing their discriminative value and subject's preference. Twelve classic CF and 17 HV underwent both NPD methods, performed by one operator in random order. A written questionnaire, assessing preference, was completed after each test. Tracings were coded, scored in a semi-blinded fashion and categorised as CF/non-CF. 110 tracings (56 Ndl/54 Abr) were collected: 42/110 scored CF and 68/110 non-CF, showing a good correlation. No significant preference for either method was reported. Both NPD methods are similar in terms of discriminative value and subject's preference, comparing classical CF and HV. For diagnosing CF, the operator's preferred NPD-method may be used. Copyright © 2015 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

Comparison of anti-plaque efficacy between a low and high cost dentifrice: A short term randomized double-blind trial

PubMed Central

Ganavadiya, Rahul; Shekar, B. R. Chandra; Goel, Pankaj; Hongal, Sudheer G.; Jain, Manish; Gupta, Ruchika

2014-01-01

Objective: The aim of this study was to compare the anti-plaque efficacy of a low and high cost commercially available tooth paste among 13-20 years old adolescents in a Residential Home, Bhopal, India. Materials and Methods: The study was randomized double-blind parallel clinical trial conducted in a Residential Home, Bhopal, India. A total of 65 patients with established dental plaque and gingivitis were randomly assigned to either low cost or high cost dentifrice group for 4 weeks. The plaque and gingival scores at baseline and post-intervention were assessed and compared. Statistical analysis was performed using paired t-test and the independent sample t-test. The statistical significance was fixed at 0.05. Results: Results indicated a significant reduction in plaque and gingival scores in both groups post-intervention compared with the baseline. Difference between the groups was not significant. No adverse events were reported and both the dentifrices were well-tolerated. Conclusion: Low cost dentifrice is equally effective to the high cost dentifrice in reducing plaque and gingival inflammation. PMID:25202220

Efficacy of topical chamomile oil for mild and moderate carpal tunnel syndrome: A randomized double-blind placebo-controlled clinical trial.

PubMed

Hashempur, Mohammad Hashem; Ghasemi, Mohammad Sadegh; Daneshfard, Babak; Ghoreishi, Parissa Sadat; Lari, Zeinab Nasiri; Homayouni, Kaynoosh; Zargaran, Arman

2017-02-01

To evaluate the efficacy of topical chamomile oil in patients with mild and moderate carpal tunnel syndrome (CTS). Eighty six patients with electrodiagnostic criteria of mild and moderate CTS were enrolled in this randomized double-blind placebo-controlled clinical trial and received wrist splint plus topical chamomile oil or placebo for 4 weeks. They were evaluated at the baseline and end of the study regarding functional and symptomatic scores, dynamometry, and electrodiagnostic indexes. Dynamometry, functionality, and symptom severity scores of the patients were significantly improved in the chamomile oil group compared with the placebo group (P = 0.040, P = 0.0001, P = 0.017, respectively). Additionally, compound latency of the median nerve in the chamomile oil group significantly decreased (P = 0.035) compared to the placebo group. Other electerodiagnostic measurements did not change significantly. Complementary treatment with topical chamomile oil may have some benefits for patients with mild and moderate CTS, both subjectively and objectively. Copyright © 2016 Elsevier Ltd. All rights reserved.

Effectiveness of Bupivacaine Liposome Injectable Suspension for Postoperative Pain Control in Total Knee Arthroplasty: A Prospective, Randomized, Double Blind, Controlled Study.

PubMed

DeClaire, Jeffrey H; Aiello, Paige M; Warritay, Olayinka K; Freeman, Dwight C

2017-09-01

We compared the effectiveness of liposomal bupivacaine to ropivacaine, each as part of multimodal pain management, in total knee arthroplasty (TKA) postoperative pain control. This prospective, double blind study randomized 96 TKA patients into a control group (periarticular injection of ropivacaine, ketorolac, morphine, and epinephrine in saline; 100cc) or an experimental group (periarticular injection of bupivacaine, ketorolac, morphine, and epinephrine in saline; 80cc plus 1.3% liposomal bupivacaine 20cc; total injection 100cc). The postoperative use of narcotics, visual analog pain scores, hours to ambulate 100 feet, and length of hospital stay were recorded. There was no significant difference between the two groups (control N = 49, experiment N = 47) in mean narcotic use per hour, total narcotic use during hospital stay, time to ambulate 100 feet, length of hospital stay, or visual analog score for pain postoperatively. There is no benefit in the use of liposomal bupivacaine compared with ropivacaine for postoperative pain control in TKA. Copyright © 2017 Elsevier Inc. All rights reserved.

Preemptive carprofen for peri-operative analgesia in dogs undergoing Tibial Plateau Leveling Osteotomy (TPLO): a prospective, randomized, blinded, placebo controlled clinical trial.

PubMed

Bufalari, A; Maggio, C; Cerasoli, I; Morath, U; Adami, C

2012-03-01

Eighteen client-owned dogs undergoing Tibial Plateau Leveling Osteotomy (TPLO) were included in this blinded clinical study and randomly assigned to one of two treatment groups. Group C (carprofen) received intravenous (IV) carprofen, 4 mg/kg, prior to anesthesia, whereas group P (placebo) received IV saline. General anesthesia was maintained with isoflurane in oxygen and a constant rate infusion (CRI) of sufentanyl IV. Intra-operatively, assessment of nociception was based on changes in physiological parameters and on the analgesics requirement, whereas in the post-operative period evaluation of pain was performed by using a Hellyer and Gaynor pain score and by comparing the doses of rescue buprenorphine required by the two treatment groups. Although no statistically significant differences in intra-operative sufentanyl doses were found between treatment groups, group C had superior cardiovascular stability, and lower post-operative pain scores and rescue buprenorphine doses than group P. Our results indicate that administration of carprofen prior to surgery was effective in improving peri-operative analgesia in dogs undergoing TPLO.

Maintenance N-acetyl cysteine treatment for bipolar disorder: a double-blind randomized placebo controlled trial.

PubMed

Berk, Michael; Dean, Olivia M; Cotton, Sue M; Gama, Clarissa S; Kapczinski, Flavio; Fernandes, Brisa; Kohlmann, Kristy; Jeavons, Susan; Hewitt, Karen; Moss, Kirsteen; Allwang, Christine; Schapkaitz, Ian; Cobb, Heidi; Bush, Ashley I; Dodd, Seetal; Malhi, Gin S

2012-08-14

N-acetyl cysteine (NAC) is a glutathione precursor that has been shown to have antidepressant efficacy in a placebo-controlled trial. The current study aimed to investigate the maintenance effects of NAC following eight weeks of open-label treatment for bipolar disorder. The efficacy of a double blind randomized placebo controlled trial of 2 g/day NAC as adjunct maintenance treatment for bipolar disorder was examined. Participants (n = 149) had a Montgomery Asberg Depression Rating Score of ≥12 at trial entry and, after eight weeks of open-label NAC treatment, were randomized to adjunctive NAC or placebo, in addition to treatment as usual. Participants (primarily outpatients) were recruited through public and private services and through newspaper advertisements. Time to intervention for a mood episode was the primary endpoint of the study, and changes in mood symptoms, functionality and quality of life measures were secondary outcomes. There was a substantial decrease in symptoms during the eight-week open-label NAC treatment phase. During the subsequent double-blind phase, there was minimal further change in outcome measures with scores remaining low. Consequently, from this low plateau, between-group differences did not emerge on recurrence, clinical functioning or quality of life measures. There were no significant between-group differences in recurrence or symptomatic outcomes during the maintenance phase of the trial; however, these findings may be confounded by limitations. The trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12607000074493).

Effect of acupuncture anesthesia on acne vulgaris of pricking-bloodletting cupping: a single-blind randomized clinical trail.

PubMed

Xu, Jianfeng; Lin, Ruizhu; Wang, Jing; Wu, Yongli; Wang, Yingxu; Zhang, Yuequan; Xi, Chaolei; Wu, Qiang

2013-12-01

To evaluate the effect on acne vulgaris of pricking-bloodletting cupping at Dazhui (GV 14) under acupuncture anesthesia, and establish whether providing anesthesia to the treatment area by manipulating Hegu (LI 4) and Quchi (LI 11) might have an additional therapeutic benefit. Thirty-eight patients were recruited and randomized into a control group and an intervention group with a single-blind (observer-blind) method. The control group was treated by pricking-bloodletting cupping at Dazhui (GV 14)-and the studied group by pricking-bloodletting cupping at Dazhui (GV 14) under acupuncture anesthesia at Hegu (LI 4) and Quchi (LI 11). Both groups were treated twice weekly for 6 weeks. The analgesic and therapeutic effects of acupuncture were evaluated on a visual analog scale (VAS) and global acne grading system (GAGS), respectively. There were differences in the VAS scores of pain on pricking and in the pricked area, and the duration of pain between the groups. After 12 treatments, there was a significant reduction in GAGS scores from baseline in both groups, but there was no significant difference between the groups. Acupuncture anesthesia at Hegu (LI 4) and Quchi (LI 11) is an effective means of alleviating the pain of pricking-bloodletting cupping and reducing the duration of pain in the treatment area. Pricking-bloodletting cupping at Dazhui (GV 14) improves the skin lesions of patients with moderate acne vulgaris, but acupuncture anesthesia does not appear to have an additional therapeutic effect.

NOTE: MCDE: a new Monte Carlo dose engine for IMRT

NASA Astrophysics Data System (ADS)

Reynaert, N.; DeSmedt, B.; Coghe, M.; Paelinck, L.; Van Duyse, B.; DeGersem, W.; DeWagter, C.; DeNeve, W.; Thierens, H.

2004-07-01

A new accurate Monte Carlo code for IMRT dose computations, MCDE (Monte Carlo dose engine), is introduced. MCDE is based on BEAMnrc/DOSXYZnrc and consequently the accurate EGSnrc electron transport. DOSXYZnrc is reprogrammed as a component module for BEAMnrc. In this way both codes are interconnected elegantly, while maintaining the BEAM structure and only minimal changes to BEAMnrc.mortran are necessary. The treatment head of the Elekta SLiplus linear accelerator is modelled in detail. CT grids consisting of up to 200 slices of 512 × 512 voxels can be introduced and up to 100 beams can be handled simultaneously. The beams and CT data are imported from the treatment planning system GRATIS via a DICOM interface. To enable the handling of up to 50 × 106 voxels the system was programmed in Fortran95 to enable dynamic memory management. All region-dependent arrays (dose, statistics, transport arrays) were redefined. A scoring grid was introduced and superimposed on the geometry grid, to be able to limit the number of scoring voxels. The whole system uses approximately 200 MB of RAM and runs on a PC cluster consisting of 38 1.0 GHz processors. A set of in-house made scripts handle the parallellization and the centralization of the Monte Carlo calculations on a server. As an illustration of MCDE, a clinical example is discussed and compared with collapsed cone convolution calculations. At present, the system is still rather slow and is intended to be a tool for reliable verification of IMRT treatment planning in the case of the presence of tissue inhomogeneities such as air cavities.

Intraoperative Nerve Blocks Fail to Improve Quality of Recovery after Tissue Expander Breast Reconstruction: A Prospective, Double-Blinded, Randomized, Placebo-Controlled Clinical Trial.

PubMed

Lanier, Steven T; Lewis, Kevin C; Kendall, Mark C; Vieira, Brittany L; De Oliveira, Gildasio; Nader, Anthony; Kim, John Y S; Alghoul, Mohammed

2018-03-01

The authors' study represents the first level I evidence to assess whether intraoperative nerve blocks improve the quality of recovery from immediate tissue expander/implant breast reconstruction. A prospective, randomized, double-blinded, placebo-controlled clinical trial was conducted in which patients undergoing immediate tissue expander/implant breast reconstruction were randomized to either (1) intraoperative intercostal and pectoral nerve blocks with 0.25% bupivacaine with 1:200,000 epinephrine and 4 mg of dexamethasone or (2) sham nerve blocks with normal saline. The 40-item Quality of Recovery score, pain score, and opioid use in the postoperative period were compared statistically between groups. Power analysis ensured 80 percent power to detect a 10-point (clinically significant) difference in the 40-item Quality of Recovery score. Forty-seven patients were enrolled. Age, body mass index, laterality, mastectomy type, and lymph node dissection were similar between groups. There were no statistical differences in quality of recovery, pain burden as measured by visual analogue scale, opioid consumption, antiemetic use, or length of hospital stay between groups at 24 hours after surgery. Mean global 40-item Quality of Recovery scores were 169 (range, 155 to 182) for the treatment arm and 165 (range, 143 to 179) for the placebo arm (p = 0.36), indicating a high quality of recovery in both groups. Although intraoperative nerve blocks can be a safe adjunct to a comprehensive postsurgical recovery regimen, the authors' results indicate no effect on overall quality of recovery from tissue expander/implant breast reconstruction. Therapeutic, I.

Therapeutic Effects of Fermented Red Ginseng in Allergic Rhinitis: A Randomized, Double-Blind, Placebo-Controlled Study

PubMed Central

Jung, Jae-Woo; Ji, Geun-Eog; Park, Myeong-Soo; Song, Woo-Jung; Kim, Min-Hye; Kwon, Jae-Woo; Kim, Tae-Whan; Park, Heung-Woo; Cho, Sang-Heon; Min, Kyung-Up

2011-01-01

Purpose Allergic rhinitis is clinically defined as a disorder of the nose induced by IgE mediated inflammation after allergen exposure of the nasal mucosa. Many reports have stated that Panax ginseng and fermented red ginseng have anti-inflammatory effects, especially against Th2-type inflammation. This study was conducted to evaluate the therapeutic effects of fermented red ginseng in allergic rhinitis. Methods In this 4-week, double-blind, placebo-controlled study, 59 patients with persistent perennial allergic rhinitis were randomly divided into two groups: those receiving fermented red ginseng tablets (experimental group) and those receiving placebo (control group). The primary efficacy variable was the total nasal symptom score (TNSS; rhinorrhea, sneezing, itchy nose, and nasal congestion). Secondary efficacy variables were the Rhinitis Quality of Life (RQoL) score and skin reactivity to inhalant allergens, as determined by the skin prick test. Results There was no significant difference in the TNSS score and TNSS duration score between the experimental and placebo groups in weeks 1, 2, 3, or 4. For nasal congestion, fermented red ginseng was significantly effective (P<0.005), while placebo caused no change. The activity and emotion of RQoL improved markedly secondary to treatment with fermented red ginseng (P<0.05), while placebo caused no change. Additionally, fermented red ginseng reduced skin reactivity to sensitized perennial allergens (P<0.05). Fermented red ginseng was well tolerated. Conclusions Fermented red ginseng improved nasal congestion symptoms and RQoL in patients with perennial allergic rhinitis. PMID:21461249

Age-Related Effects of Stimulus Type and Congruency on Inattentional Blindness.

PubMed

Liu, Han-Hui

2018-01-01

Background: Most of the previous inattentional blindness (IB) studies focused on the factors that contributed to the detection of unattended stimuli. The age-related changes on IB have rarely been investigated across all age groups. In the current study, by using the dual-task IB paradigm, we aimed to explore the age-related effects of attended stimuli type and congruency between attended and unattended stimuli on IB. Methods: The current study recruited 111 participants (30 adolescents, 48 young adults, and 33 middle-aged adults) in the baseline recognition experiments and 341 participants (135 adolescents, 135 young adults, and 71 middle-aged adults) in the IB experiment. We applied the superimposed picture and word streams experimental paradigm to explore the age-related effects of attended stimuli type and congruency between attended and unattended stimuli on IB. An ANOVA was performed to analyze the results. Results: Participants across all age groups presented significantly lower recognition scores for both pictures and words in comparison with baseline recognition. Participants presented decreased recognition for unattended pictures or words from adolescents to young adults and middle-aged adults. When the pictures and words are congruent, all the participants showed significantly higher recognition scores for unattended stimuli in comparison with incongruent condition. Adolescents and young adults did not show recognition differences when primary tasks were attending pictures or words. Conclusion: The current findings showed that all participants presented better recognition scores for attended stimuli in comparison with unattended stimuli, and the recognition scores decreased from the adolescents to young and middle-aged adults. The findings partly supported the attention capacity models of IB.

Effect of Hydroxychloroquine Treatment on Dry Eyes in Subjects with Primary Sjögren’s Syndrome: a Double-Blind Randomized Control Study

PubMed Central

2016-01-01

The effect of hydroxychloroquine (HCQ) on dry eye has not been fully determined. This study aimed to compare the 12-week efficacy of HCQ medication with that of a placebo in the management of dry eye in primary Sjögren's syndrome (pSS). A double-blind, randomized control study was conducted in 39 pSS subjects from May 2011 through August 2013. pSS was diagnosed based on the classification criteria of the American-European Consensus Group. Subjects received 300 mg of HCQ or placebo once daily for 12 weeks and were evaluated at baseline, 6, and 12 weeks, with a re-visit at 16 weeks after drug discontinuance. The fluorescein staining score, Schirmer test score, tear film break-up time (TBUT), and ocular surface disease index (OSDI) were measured, and tears and blood were collected for ESR, IL-6, IL-17, B-cell activating factor (BAFF), and Th17 cell analysis. Color testing was performed and the fundus was examined to monitor HCQ complications. Twenty-six subjects completed the follow-up. The fluorescein staining score and Schirmer test score did not differ significantly. The OSDI improved with medication in the HCQ group but was not significantly different between the groups. TBUT, serum IL-6, ESR, serum and tear BAFF, and the proportion of Th17 cells did not change in either group. HCQ at 300 mg daily for 12 weeks has no apparent clinical benefit for dry eye and systemic inflammation in pSS (ClinicalTrials.gov. NCT01601028). PMID:27366013

Protection of Salivary Function by Concomitant Pilocarpine During Radiotherapy: A Double-Blind, Randomized, Placebo-Controlled Study

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

Burlage, Fred R.; Roesink, Judith M.; Kampinga, Harm H.

2008-01-01

Purpose: To investigate the effect of concomitant administration of pilocarpine during radiotherapy for head-and-neck squamous cell carcinoma (HNSCC) on postradiotherapy xerostomia. Methods and Materials: A prospective, double blind, placebo-controlled randomized trial including 170 patients with HNSCC was executed to study the protective effect of pilocarpine on radiotherapy-induced parotid gland dysfunction. The primary objective endpoint was parotid flow rate complication probability (PFCP) scored 6 weeks, 6 months, and 12 months after radiotherapy. Secondary endpoints included Late Effects of Normal Tissue/Somatic Objective Management Analytic scale (LENT SOMA) and patient-rated xerostomia scores. For all parotid glands, dose-volume histograms were assessed because the dosemore » distribution in the parotid glands is considered the most important prognostic factor with regard to radiation-induced salivary dysfunction. Results: Although no significant differences in PFCP were found for the two treatments arms, a significant (p = 0.03) reduced loss of parotid flow 1 year after radiotherapy was observed in those patients who received pilocarpine and a mean parotid dose above 40 Gy. The LENT SOMA and patient-rated xerostomia scores showed similar trends toward less dryness-related complaints for the pilocarpine group. Conclusions: Concomitant administration of pilocarpine during radiotherapy did not improve the PFCP or LENT SOMA and patient-rated xerostomia scores. In a subgroup of patients with a mean dose above 40 Gy, pilocarpine administration resulted in sparing of parotid gland function. Therefore, pilocarpine could be provided to patients in whom sufficient sparing of the parotid is not achievable.« less

Effect of Hydroxychloroquine Treatment on Dry Eyes in Subjects with Primary Sjögren's Syndrome: a Double-Blind Randomized Control Study.

PubMed

Yoon, Chang Ho; Lee, Hyun Ju; Lee, Eun Young; Lee, Eun Bong; Lee, Won-Woo; Kim, Mee Kum; Wee, Won Ryang

2016-07-01

The effect of hydroxychloroquine (HCQ) on dry eye has not been fully determined. This study aimed to compare the 12-week efficacy of HCQ medication with that of a placebo in the management of dry eye in primary Sjögren's syndrome (pSS). A double-blind, randomized control study was conducted in 39 pSS subjects from May 2011 through August 2013. pSS was diagnosed based on the classification criteria of the American-European Consensus Group. Subjects received 300 mg of HCQ or placebo once daily for 12 weeks and were evaluated at baseline, 6, and 12 weeks, with a re-visit at 16 weeks after drug discontinuance. The fluorescein staining score, Schirmer test score, tear film break-up time (TBUT), and ocular surface disease index (OSDI) were measured, and tears and blood were collected for ESR, IL-6, IL-17, B-cell activating factor (BAFF), and Th17 cell analysis. Color testing was performed and the fundus was examined to monitor HCQ complications. Twenty-six subjects completed the follow-up. The fluorescein staining score and Schirmer test score did not differ significantly. The OSDI improved with medication in the HCQ group but was not significantly different between the groups. TBUT, serum IL-6, ESR, serum and tear BAFF, and the proportion of Th17 cells did not change in either group. HCQ at 300 mg daily for 12 weeks has no apparent clinical benefit for dry eye and systemic inflammation in pSS (ClinicalTrials.gov. NCT01601028).

Non-invasive high-intensity focused ultrasound for UV-induced hyperpigmentation in Fitzpatrick skin types III and IV: a prospective, randomized, controlled, evaluator-blinded trial.

PubMed

Vachiramon, Vasanop; Jurairattanaporn, Natthachat; Harnchoowong, Sarawin; Chayavichitsilp, Pamela

2018-02-01

Skin hyperpigmentation is a frequently encountered problem, particularly in darker skin types. Unfortunately, standard treatments for this condition have shown disappointing results. High-intensity focused ultrasound (HIFU) is commonly indicated for skin laxity, but recently was used to treat UV-induced hyperpigmentation in animal models. This study is aimed to evaluate the efficacy and safety of high-intensity focused ultrasound for UVB-induced hyperpigmentation in human subjects. A randomized, evaluator-blinded pilot study was conducted on 20 subjects. Each subject was induced three hyperpigmentary spots by local broadband UVB. After 2 weeks, each spot was randomly allocated to control, low-energy, and high-energy HIFU. Subjects were instructed to follow up weekly for a duration of 1 month. Lightness index measurements, mean improvement scores, subjects' satisfaction, pain scores, and side effects were evaluated. All 20 subjects completed the study. Fourteen subjects had Fitzpatrick (FPT) skin type III and six subjects had FPT skin type IV. Twelve subjects showed greater improvement at control sites while eight subjects showed greater improvement at HIFU-treated sites. In FPT skin type III, HIFU appeared to be inferior to control in both lightness index and mean improvement scores, but in FPT skin type IV, HIFU had greater lightness index improvement and higher improvement scores than control. Side effects were more frequent in high-energy-treated areas. Focused ultrasound may be offered in some patients with hyperpigmentary conditions. More research is needed to determine proper energy settings for optimal outcome.

A randomized clinical trial of an intervention to relieve thirst and dry mouth in intensive care unit patients.

PubMed

Puntillo, Kathleen; Arai, Shoshana R; Cooper, Bruce A; Stotts, Nancy A; Nelson, Judith E

2014-09-01

To test an intervention bundle for thirst intensity, thirst distress, and dry mouth, which are among the most pervasive, intense, distressful, unrecognized, and undertreated symptoms in ICU patients, but for which data-based interventions are lacking. This was a single-blinded randomized clinical trial in three ICUs in a tertiary medical center in urban California. A total of 252 cognitively intact patients reporting thirst intensity (TI) and/or thirst distress (TD) scores ≥3 on 0-10 numeric rating scales (NRS) were randomized to intervention or usual care groups. A research team nurse (RTN#1) obtained patients' pre-procedure TI and TD scores and reports of dry mouth. She then administered a thirst bundle to the intervention group: oral swab wipes, sterile ice-cold water sprays, and a lip moisturizer, or observed patients in the usual care group. RTN#2, blinded to group assignment, obtained post-procedure TI and TD scores. Up to six sessions per patient were conducted across 2 days. Multilevel linear regression determined that the average decreases in TI and TD scores from pre-procedure to post-procedure were significantly greater in the intervention group (2.3 and 1.8 NRS points, respectively) versus the usual care group (0.6 and 0.4 points, respectively) (p < 0.05). The usual care group was 1.9 times more likely than the intervention group to report dry mouth for each additional session on day 1. This simple, inexpensive thirst bundle significantly decreased ICU patients' thirst and dry mouth and can be considered a practice intervention for patients experiencing thirst.

Eight weeks of omeprazole 20 mg significantly reduces both laryngopharyngeal reflux and comorbid chronic rhinosinusitis signs and symptoms: Randomised, double-blind, placebo-controlled trial.

PubMed

Anzić, S A; Turkalj, M; Župan, A; Labor, M; Plavec, D; Baudoin, T

2018-04-01

Gastroesophageal reflux recommended treatment (dose and duration) with proton-pump inhibitor (PPI) compared to placebo significantly reduces the signs and symptoms of laryngopharyngeal reflux (LPR) and comorbid chronic rhinosinusitis (CRS). Double-blind randomised placebo-controlled trial. Eight weeks of treatment with omeprazole 20 mg once daily (OD). Sixty patients (28 women, aged 19-87 years) with diagnosed LPR and comorbid CRS. Significant reduction in signs and symptoms (reflux symptom index (RSI) score as subjective, and reflux finding score (RFS) as objective measure) of LPR after 8 weeks of treatment with omeprazole 20 mg OD when compared to placebo. Secondary objectives were significant reduction in signs and symptoms of comorbid CRS after 8 weeks of treatment with omeprazole 20 mg OD when compared to placebo and the association of the severity of signs and symptoms of LPR with the ones of CRS. RSI and RFS decreased significantly more in the active treatment group after 8 weeks compared to placebo (P < .001 for both). CRS and endoscopy scoring decreased both significantly more in the active group after 8 weeks compared to placebo (P < .001 for both). CRS scoring significantly correlated with RSI (R = 0.312, P = .015) but not with RFS (R = 0.199, P = .127). The results of our trial suggest that omeprazole 20 mg OD for 8 weeks was effective in reducing signs and symptoms of both LPR and CRS, although in most patients still present at the end of the trial. © 2017 John Wiley & Sons Ltd.

Trial of Music, Sucrose, and Combination Therapy for Pain Relief during Heel Prick Procedures in Neonates.

PubMed

Shah, Swapnil R; Kadage, Shahajahan; Sinn, John

2017-11-01

To compare the effectiveness of music, oral sucrose, and combination therapy for pain relief in neonates undergoing a heel prick procedure. This randomized, controlled, blinded crossover clinical trial included stable neonates >32 weeks of postmenstrual age. Each neonate crossed over to all 3 interventions in random order during consecutive heel pricks. A video camera on mute mode recorded facial expressions, starting 2 minutes before until 7 minutes after the heel prick. The videos were later analyzed using the Premature Infant Pain Profile-Revised (PIPP-R) scale once per minute by 2 independent assessors, blinded to the intervention. The PIPP-R scores were compared between treatment groups using Friedman test. For the 35 participants, the postmenstrual age was 35 weeks (SD, 2.3) with an average weight of 2210 g (SD, 710). The overall median PIPP-R scores following heel prick over 6 minutes were 4 (IQR 0-6), 3 (IQR 0-6), and 1 (IQR 0-3) for the music, sucrose, and combination therapy interventions, respectively. The PIPP-R scores were significantly lower at all time points after combination therapy compared with the groups given music or sucrose alone. There was no difference in PIPP-R scores between the music and sucrose groups. In relatively stable and mature neonates, the combination of music therapy with sucrose provided better pain relief during heel prick than when sucrose or music was used alone. Recorded music in isolation had a similar effect to the current gold standard of oral sucrose. www.anzctr.org.au ACTRN12615000271505. Copyright © 2017 Elsevier Inc. All rights reserved.

Warming and humidification of insufflation carbon dioxide in laparoscopic colonic surgery: a double-blinded randomized controlled trial.

PubMed

Sammour, Tarik; Kahokehr, Arman; Hayes, Julian; Hulme-Moir, Mike; Hill, Andrew G

2010-06-01

We aimed to test the hypothesis that warming and humidification of insufflation CO2 would lead to reduced postoperative pain and improved recovery by reducing peritoneal inflammation in laparoscopic colonic surgery. Warming and humidification of insufflation gas is thought be beneficial in laparoscopic surgery, but evidence in prolonged laparoscopic procedures is lacking. We used a multicenter, double-blinded, randomized controlled design. The Study Group received warmed (37 degrees C), humidified (98% RH) insufflation carbon dioxide, and the Control Group received standard gas (19 degrees C, 0% RH). Anesthesia and analgesia were standardized. Intraoperative oesophageal temperature was measured at 15 minutes intervals. At the conclusion of surgery, the primary surgeon was asked to rate camera fogging on a Likert scale. Postoperative opiate usage was determined using Morphine Equivalent Daily Dose (MEDD), and pain was measured using visual analogue scores. Peritoneal and plasma cytokine concentrations were measured at 20 hours postoperatively. Postoperative recovery was measured using defined discharge and complication criteria, and the Surgical Recovery Score. Eighty-two patients were randomized, with 41 in each arm. Groups were well matched at baseline. Intraoperative core temperature was similar in both groups. Median camera fogging score was significantly worse in the Study group (4 vs. 2, P = 0.040). There were marginal differences in pain scores, but no significant differences were detected in MEDD usage, cytokine concentrations, or any recovery parameters measured. Warming and humidification of insufflation CO2 does not attenuate the early inflammatory cytokine response, and confers no clinically significant benefit in laparoscopic colonic surgery.

Subjective Psychological Well-Being in Families with Blind Children: How Can We Improve It?

PubMed Central

Sola-Carmona, Juan J.; Lopez-Liria, Remedios; Padilla-Gongora, David; Daza, María T.; Aguilar-Parra, Jose M.

2016-01-01

The aim of this work was to examine family well-being in a sample of Spanish families with blind children. Sixty-one participants reported their perceived economic status, the level of job satisfaction, and state-anxiety symptoms. The participants of our study scored higher on state-anxiety and lower on material well-being than the normative sample, although these differences did not reach statistical significance. They also scored higher on job satisfaction and family satisfaction than the general population. A negative correlation was found between state-anxiety and material well-being (r = - 0.62, p = 0.001) and between state-anxiety and family satisfaction (r = - 0.57, p = 0.001). A positive correlation was found between material well-being and job satisfaction (r = 0.40, p = 0.001), and between material well-being and family satisfaction (r = 0.41, p = 0.001). Higher levels of material well-being, job satisfaction, and family satisfaction were associated with lower levels of anxiety in these families. However, no statistically significant correlation was found between family satisfaction and job satisfaction. Our results suggest that the family experience of having a disabled child is evolving, and this implies achieving greater job and family satisfaction than the normative samples, although anxiety scores continue to be higher and material well-being scores remain lower. On the whole, our results confirm that it is necessary to provide these families with more economic resources, which would have a positive impact on their subjective psychological well-being, decreasing their state-anxiety, and increasing their satisfaction with life. PMID:27092095

Exploring the use of Option Grid™ patient decision aids in a sample of clinics in Poland.

PubMed

Scalia, Peter; Elwyn, Glyn; Barr, Paul; Song, Julia; Zisman-Ilani, Yaara; Lesniak, Monika; Mullin, Sarah; Kurek, Krzysztof; Bushell, Matt; Durand, Marie-Anne

2018-05-29

Research on the implementation of patient decision aids to facilitate shared decision making in clinical settings has steadily increased across Western countries. A study which implements decision aids and measures their impact on shared decision making has yet to be conducted in the Eastern part of Europe. To study the use of Option Grid TM patient decision aids in a sample of Grupa LUX MED clinics in Warsaw, Poland, and measure their impact on shared decision making. We conducted a pre-post interventional study. Following a three-month period of usual care, clinicians from three Grupa LUX MED clinics received a one-hour training session on how to use three Option Grid TM decision aids and were provided with copies for use for four months. Throughout the study, all eligible patients were asked to complete the three-item CollaboRATE patient-reported measure of shared decision making after their clinical encounter. CollaboRATE enables patients to assess the efforts clinicians make to: (i) inform them about their health issues; (ii) listen to 'what matters most'; (iii) integrate their treatment preference in future plans. A Hierarchical Logistic Regression model was performed to understand which variables had an effect on CollaboRATE. 2,048 patients participated in the baseline phase; 1,889 patients participated in the intervention phase. Five of the thirteen study clinicians had a statistically significant increase in their CollaboRATE scores (p<.05) when comparing baseline phase to intervention phase. All five clinicians were located at the same clinic, the only clinic where an overall increase (non-significant) in the mean CollaboRATE top score percentage occurred from baseline phase (M=60 %, SD=0.49; 95 % CI [57-63 %]) to intervention phase (M=62 %, SD=0.49; 95% CI [59-65%]). Only three of those five clinicians who had a statistically significant increase had a clinically significant difference. The implementation of Option Grid TM helped some clinicians practice shared decision making as reflected in CollaboRATE scores, but most clinicians did not have a significant increase in their scores. Our study indicates that the effect of these interventions may be dependent on clinic contexts and clinician engagement. Copyright © 2018. Published by Elsevier GmbH.

Using Option Grids: steps toward shared decision-making for neonatal circumcision.

PubMed

Fay, Mary; Grande, Stuart W; Donnelly, Kyla; Elwyn, Glyn

2016-02-01

To assess the impact, acceptability and feasibility of a short encounter tool designed to enhance the process of shared decision-making and parental engagement. We analyzed video-recordings of clinical encounters, half undertaken before and half after a brief intervention that trained four clinicians how to use Option Grids, using an observer-based measure of shared decision-making. We also analyzed semi-structured interviews conducted with the clinicians four weeks after their exposure to the intervention. Observer OPTION(5) scores were higher at post-intervention, with a mean of 33.9 (SD=23.5) compared to a mean of 16.1 (SD=7.1) for pre-intervention, a significant difference of 17.8 (95% CI: 2.4, 33.2). Prior to using the intervention, clinicians used a consent document to frame circumcision as a default practice. Encounters with the Option Grid conferred agency to both parents and clinicians, and facilitated shared decision-making. Clinician reported recognizing the tool's positive effect on their communication process. Tools such as Option Grids have the potential to make it easier for clinicians to achieve shared decision-making. Encounter tools have the potential to change practice. More research is needed to test their feasibility in routine practice. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Clinical reinvestigation and linkage analysis in the family with Episkopi blindness (Norrie disease).

PubMed

Wolff, G; Mayerová, A; Wienker, T F; Atalianis, P; Ioannou, P; Warburg, M

1992-11-01

We present the results of a clinical and genetic reinvestigation of the Cypriot family affected by an X chromosomally inherited eye disease originally published by Taylor et al, who coined the term Episkopi blindness. The pedigree was extended to 160 members, including 16 affected males out of 48 males at risk for the disease, most of whom were seen by one of us (PA). Affected males are blind with no associated symptoms and apparently are not mentally retarded. Thirty-nine family members agreed to blood sampling for genetic investigations. RFLP analysis was performed using probes from the region known to be deleted in some Norrie patients and polymorphic markers (DXS77, DXS7, MAOA, DXS255) from the proximal short arm of the X chromosome. There was no deletion for any of the probes in the affected males. Linkage analysis yielded positive lod scores for all informative markers (Z (DXS255, theta = 0) = 6.54, Z (MAOA, theta = 0) = 2.23, Z (DXS7, theta = 0) = 2.13). Thus, the conclusion that Episkopi blindness and Norrie disease (NDP, MIM *310600) are the same entity based on clinical evidence is now reinforced by gene mapping.

Assessment of visual disability using the WHO disability assessment scale (WHO-DAS-II): role of gender.

PubMed

Badr, H E; Mourad, H

2009-10-01

To study the role of gender in coping with disability in young visually impaired students attending two schools for blindness. The WHO Disability Assessment Schedule (WHODAS II), 36-Item Interviewer Administered translated Arabic version was used. It evaluates six domains of everyday living in the last 30 days. These domains are: understanding and communicating, getting around, self care, getting along with people, household activities and participation in society. Face-to-face interviews were conducted with 200 students who represented the target population of the study. Binary logistic regression analysis of the scores of the six domains revealed that in all of the domains except getting along with people and coping with school activities, females significantly faced more difficulties in coping with daily life activities than did their male counterparts. Increasing age significantly increased difficulties in coping with school activities. Genetic causes of blindness were associated with increased difficulties. Females face more difficulties in coping with visual disability. Genetic counselling is needed to decrease the prevalence of visual disability. Girls with blindness need additional inputs to help cope with blindness. Early intervention facilitates dealing with school activities of the visually impaired.

Clinical reinvestigation and linkage analysis in the family with Episkopi blindness (Norrie disease).

PubMed Central

Wolff, G; Mayerová, A; Wienker, T F; Atalianis, P; Ioannou, P; Warburg, M

1992-01-01

We present the results of a clinical and genetic reinvestigation of the Cypriot family affected by an X chromosomally inherited eye disease originally published by Taylor et al, who coined the term Episkopi blindness. The pedigree was extended to 160 members, including 16 affected males out of 48 males at risk for the disease, most of whom were seen by one of us (PA). Affected males are blind with no associated symptoms and apparently are not mentally retarded. Thirty-nine family members agreed to blood sampling for genetic investigations. RFLP analysis was performed using probes from the region known to be deleted in some Norrie patients and polymorphic markers (DXS77, DXS7, MAOA, DXS255) from the proximal short arm of the X chromosome. There was no deletion for any of the probes in the affected males. Linkage analysis yielded positive lod scores for all informative markers (Z (DXS255, theta = 0) = 6.54, Z (MAOA, theta = 0) = 2.23, Z (DXS7, theta = 0) = 2.13). Thus, the conclusion that Episkopi blindness and Norrie disease (NDP, MIM *310600) are the same entity based on clinical evidence is now reinforced by gene mapping. Images PMID:1453434

Methodological reporting of randomized trials in five leading Chinese nursing journals.

PubMed

Shi, Chunhu; Tian, Jinhui; Ren, Dan; Wei, Hongli; Zhang, Lihuan; Wang, Quan; Yang, Kehu

2014-01-01

Randomized controlled trials (RCTs) are not always well reported, especially in terms of their methodological descriptions. This study aimed to investigate the adherence of methodological reporting complying with CONSORT and explore associated trial level variables in the Chinese nursing care field. In June 2012, we identified RCTs published in five leading Chinese nursing journals and included trials with details of randomized methods. The quality of methodological reporting was measured through the methods section of the CONSORT checklist and the overall CONSORT methodological items score was calculated and expressed as a percentage. Meanwhile, we hypothesized that some general and methodological characteristics were associated with reporting quality and conducted a regression with these data to explore the correlation. The descriptive and regression statistics were calculated via SPSS 13.0. In total, 680 RCTs were included. The overall CONSORT methodological items score was 6.34 ± 0.97 (Mean ± SD). No RCT reported descriptions and changes in "trial design," changes in "outcomes" and "implementation," or descriptions of the similarity of interventions for "blinding." Poor reporting was found in detailing the "settings of participants" (13.1%), "type of randomization sequence generation" (1.8%), calculation methods of "sample size" (0.4%), explanation of any interim analyses and stopping guidelines for "sample size" (0.3%), "allocation concealment mechanism" (0.3%), additional analyses in "statistical methods" (2.1%), and targeted subjects and methods of "blinding" (5.9%). More than 50% of trials described randomization sequence generation, the eligibility criteria of "participants," "interventions," and definitions of the "outcomes" and "statistical methods." The regression analysis found that publication year and ITT analysis were weakly associated with CONSORT score. The completeness of methodological reporting of RCTs in the Chinese nursing care field is poor, especially with regard to the reporting of trial design, changes in outcomes, sample size calculation, allocation concealment, blinding, and statistical methods.

The efficacy and resource utilization of remifentanil and fentanyl in fast-track coronary artery bypass graft surgery: a prospective randomized, double-blinded controlled, multi-center trial.

PubMed

Cheng, D C; Newman, M F; Duke, P; Wong, D T; Finegan, B; Howie, M; Fitch, J; Bowdle, T A; Hogue, C; Hillel, Z; Pierce, E; Bukenya, D

2001-05-01

We compared (a) the perioperative complications; (b) times to eligibility for, and actual time of the following: extubation, less intense monitoring, intensive care unit (ICU), and hospital discharge; and (c) resource utilization of nursing ratio for patients receiving either a typical fentanyl/isoflurane/propofol regimen or a remifentanil/isoflurane/propofol regimen for fast-track cardiac anesthesia in 304 adults by using a prospective randomized, double-blinded, double-dummy trial. There were no differences in demographic data, or perioperative mortality and morbidity between the two study groups. The mini-mental status examination at postoperative Days 1 to 3 were similar between the two groups. The eligible and actual times for extubation, less intense monitoring, ICU discharge, and hospital discharge were not significantly different. Further analyses revealed no differences in times for extubation and resource utilization after stratification by preoperative risk scores, age, and country. The nurse/patient ratio was similar between the remifentanil/isoflurane/propofol and fentanyl/isoflu-rane/propofol groups during the initial ICU phase and less intense monitoring phase. Increasing preoperative risk scores and older age (>70 yr) were associated with longer times until extubation (eligible), ICU discharge (eligible and actual), and hospital discharge (eligible and actual). Times until extubation (eligible and actual) and less intense monitoring (eligible) were significantly shorter in Canadian patients than United States' patients. However, there was no difference in hospital length of stay in Canadian and United States' patients. We conclude that both anesthesia techniques permit early and similar times until tracheal extubation, less intense monitoring, ICU and hospital discharge, and reduced resource utilization after coronary artery bypass graft surgery. An ultra-short opioid technique was compared with a standard fast-track small-dose opioid technique in coronary artery bypass graft patients in a prospective randomized, double-blinded controlled study. The postoperative recovery and resource utilization, including stratification of preoperative risk score, age, and country, were analyzed.

One year double blind study of high vs low frequency subcallosal cingulate stimulation for depression.

PubMed

Eitan, Renana; Fontaine, Denys; Benoît, Michel; Giordana, Caroline; Darmon, Nelly; Israel, Zvi; Linesky, Eduard; Arkadir, David; Ben-Naim, Shiri; Iserlles, Moshe; Bergman, Hagai; Hulse, Natasha; Abdelghani, Mohamed; McGuffin, Peter; Farmer, Anne; DeLea, Peichel; Ashkan, Keyoumars; Lerer, Bernard

2018-01-01

Subcallosal Brodmann's Area 25 (Cg25) Deep Brain Stimulation (DBS) is a new promising therapy for treatment resistant major depressive disorder (TR-MDD). While different DBS stimulating parameters may have an impact on the efficacy and safety of the therapy, there is no data to support a protocol for optimal stimulation parameters for depression. Here we present a prospective multi-center double-blind randomized crossed-over 13-month study that evaluated the effects of High (130 Hz) vs Low (20 Hz) frequency Cg25 stimulation for nine patients with TR-MDD. Four out of nine patients achieved response criteria (≥40% reduction of symptom score) compared to mean baseline values at the end of the study. The mean percent change of MADRS score showed a similar improvement in the high and low frequency stimulation groups after 6 months of stimulation (-15.4 ± 21.1 and -14.7 ± 21.1 respectively). The mean effect at the end of the second period (6 months after cross-over) was higher than the first period (first 6 months of stimulation) in all patients (-23.4 ± 19.9 (n = 6 periods) and -13.0 ± 22 (n = 9 periods) respectively). At the end of the second period, the mean percent change of the MADRS scores improved more in the high than low frequency groups (-31.3 ± 19.3 (n = 4 patients) and -7.7 ± 10.9 (n = 2 patients) respectively). Given the small numbers, detailed statistical analysis is challenging. Nonetheless the results of this study suggest that long term high frequency stimulation might confer the best results. Larger scale, randomized double blind trials are needed in order to evaluate the most effective stimulation parameters. Copyright © 2017 Elsevier Ltd. All rights reserved.

The relationship between early changes in the HAMD-17 anxiety/somatization factor items and treatment outcome among depressed outpatients.

PubMed

Farabaugh, Amy; Mischoulon, David; Fava, Maurizio; Wu, Shirley L; Mascarini, Alessandra; Tossani, Eliana; Alpert, Jonathan E

2005-03-01

The 17-item Hamilton Rating Scale for Depression (HAMD-17) Anxiety/Somatization factor includes six items: Anxiety (psychic), Anxiety (somatic), Somatic Symptoms (gastrointestinal), Somatic Symptoms (general), Hypochondriasis and Insight. This study examines the relationship between early changes (defined as those observed between baseline and week 1) in these HAMD-17 Anxiety/Somatization Factor items and treatment outcome among major depressive disorder (MDD) patients who participated in a study comparing the antidepressant efficacy of a standardized extract of hypericum with both placebo and fluoxetine. Following a 1-week, single-blind washout, patients with MDD diagnosed by the Structured Clinical Interview for DSM-IV (SCID) were randomized to 12 weeks of double-blind treatment with hypericum extract (900 mg/day), fluoxetine (20 mg/day) or placebo. The relationship between early changes in HAMD-17 anxiety/somatization factor items and treatment outcome was assessed separately for patients who received study treatment (hypericum or fluoxetine) versus placebo with a logistic regression method. One hundred and thirty-five patients (female 57%, mean age=37.3+/-11.0 years; mean baseline HAMD-17=19.7+/-3.2 years) were randomized to double-blind treatment and were included in the intent-to-treat (ITT) analyses. After adjusting for baseline HAMD-17 scores and for multiple comparisons with the Bonferroni correction, patients who remitted (HAMD-17 score <8) after study treatment had significantly greater early improvement in Somatic Symptoms (General) scores than non-remitters. No other significant differences in early changes were noted for the remaining items between remitters versus non-remitters who received active treatment. For patients treated with placebo, early change was not predictive of remission for any of the items after Bonferroni correction. In conclusion, the presence of early improvement on the HAMD-17 item concerning fatigue and general somatic symptoms is significantly predictive of achieving remission at endpoint with active study treatment but not with placebo.

KINECT 3: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Valbenazine for Tardive Dyskinesia.

PubMed

Hauser, Robert A; Factor, Stewart A; Marder, Stephen R; Knesevich, Mary Ann; Ramirez, Paul M; Jimenez, Roland; Burke, Joshua; Liang, Grace S; O'Brien, Christopher F

2017-05-01

Tardive dyskinesia is a persistent movement disorder induced by dopamine receptor blockers, including antipsychotics. Valbenazine (NBI-98854) is a novel, highly selective vesicular monoamine transporter 2 inhibitor that demonstrated favorable efficacy and tolerability in the treatment of tardive dyskinesia in phase 2 studies. This phase 3 study further evaluated the efficacy, safety, and tolerability of valbenazine as a treatment for tardive dyskinesia. This 6-week, randomized, double-blind, placebo-controlled trial included patients with schizophrenia, schizoaffective disorder, or a mood disorder who had moderate or severe tardive dyskinesia. Participants were randomly assigned in a 1:1:1 ratio to once-daily placebo, valbenazine at 40 mg/day, or valbenazine at 80 mg/day. The primary efficacy endpoint was change from baseline to week 6 in the 80 mg/day group compared with the placebo group on the Abnormal Involuntary Movement Scale (AIMS) dyskinesia score (items 1-7), as assessed by blinded central AIMS video raters. Safety assessments included adverse event monitoring, laboratory tests, ECG, and psychiatric measures. The intent-to-treat population included 225 participants, of whom 205 completed the study. Approximately 65% of participants had schizophrenia or schizoaffective disorder, and 85.5% were receiving concomitant antipsychotics. Least squares mean change from baseline to week 6 in AIMS dyskinesia score was -3.2 for the 80 mg/day group, compared with -0.1 for the placebo group, a significant difference. AIMS dyskinesia score was also reduced in the 40 mg/day group (-1.9 compared with -0.1). The incidence of adverse events was consistent with previous studies. Once-daily valbenazine significantly improved tardive dyskinesia in participants with underlying schizophrenia, schizoaffective disorder, or mood disorder. Valbenazine was generally well tolerated, and psychiatric status remained stable. Longer trials are necessary to understand the long-term effects of valbenazine in patients with tardive dyskinesia.

A double-blind placebo-controlled trial of maca root as treatment for antidepressant-induced sexual dysfunction in women.

PubMed

Dording, Christina M; Schettler, Pamela J; Dalton, Elizabeth D; Parkin, Susannah R; Walker, Rosemary S W; Fehling, Kara B; Fava, Maurizio; Mischoulon, David

2015-01-01

Objective. We sought to demonstrate that maca root may be an effective treatment for antidepressant-induced sexual dysfunction (AISD) in women. Method. We conducted a 12-week, double-blind, placebo-controlled trial of maca root (3.0 g/day) in 45 female outpatients (mean age of 41.5 ± 12.5 years) with SSRI/SNRI-induced sexual dysfunction whose depression remitted. Endpoints were improvement in sexual functioning as per the Arizona Sexual Experience Scale (ASEX) and the Massachusetts General Hospital Sexual Function Questionnaire (MGH-SFQ). Results. 45 of 57 consented females were randomized, and 42 (30 premenopausal and 12 postmenopausal women) were eligible for a modified intent-to-treat analysis based on having had at least one postmedication visit. Remission rates by the end of treatment were higher for the maca than the placebo group, based on attainment of an ASEX total score ≤ 10 (9.5% for maca versus 4.8% for placebo), attaining an MGH-SFQ score ≤ 12 (30.0% for maca versus 20.0% for placebo) and reaching an MGH-SFQ score ≤ 8 (9.5% for maca versus 5.0% for placebo). Higher remission rates for the maca versus placebo group were associated with postmenopausal status. Maca was well tolerated. Conclusion. Maca root may alleviate SSRI-induced sexual dysfunction in postmenopausal women. This trial is registered with NCT00568126.

Reliable assessment of laparoscopic performance in the operating room using videotape analysis.

PubMed

Chang, Lily; Hogle, Nancy J; Moore, Brianna B; Graham, Mark J; Sinanan, Mika N; Bailey, Robert; Fowler, Dennis L

2007-06-01

The Global Operative Assessment of Laparoscopic Skills (GOALS) is a valid assessment tool for objectively evaluating the technical performance of laparoscopic skills in surgery residents. We hypothesized that GOALS would reliably differentiate between an experienced (expert) and an inexperienced (novice) laparoscopic surgeon (construct validity) based on a blinded videotape review of a laparoscopic cholecystectomy procedure. Ten board-certified surgeons actively engaged in the practice and teaching of laparoscopy reviewed and evaluated the videotaped operative performance of one novice and one expert laparoscopic surgeon using GOALS. Each reviewer recorded a score for both the expert and the novice videotape reviews in each of the 5 domains in GOALS (depth perception, bimanual dexterity, efficiency, tissue handling, and overall competence). The scores for the expert and the novice were compared and statistically analyzed using single-factor analysis of variance (ANOVA). The expert scored significantly higher than the novice did in the domains of depth perception (p = .005), bimanual dexterity (p = .001), efficiency (p = .001), and overall competence ( p = .001). Interrater reliability for the reviewers of the novice tape was Cronbach alpha = .93 and the expert tape was Cronbach alpha = .87. There was no difference between the two for tissue handling. The Global Operative Assessment of Laparoscopic Skills is a valid, objective assessment tool for evaluating technical surgical performance when used to blindly evaluate an intraoperative videotape recording of a laparoscopic procedure.

Topical Silymarin Administration for Prevention of Capecitabine-Induced Hand-Foot Syndrome: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial.

PubMed

Elyasi, Sepideh; Shojaee, Farzaneh Sadat Rezazadeh; Allahyari, Abolghasem; Karimi, Gholamreza

2017-09-01

Hand-foot syndrome (HFS) is a frequent dose-limiting adverse reaction of capecitabine in patient with gastrointestinal cancers. Silymarin is a polyphenolic flavonoid extracted from the Silybum marianum that exhibits strong antioxidant and antiinflammatory activities. In this study, we evaluated silymarin efficacy in prevention of capecitabine-induced HFS in patients with gastrointestinal cancers, as the first human study. During this pilot, randomized, double-blinded, placebo-controlled clinical trial, the effect of silymarin gel 1%, which is applied on the palms and soles twice daily starting at the first day of chemotherapy for 9 weeks, on HFS occurrence was assessed. Forty patients fulfilled the inclusion criteria assigned to the silymarin or placebo group. World Health Organization HFS grading scale scores were recorded at baseline and every 3 weeks during these 9 weeks. The median WHO HFS scores were significantly lower in silymarin group at the end of the 9 th week (p < 0.05). The scores increased significantly in both placebo and silymarin groups during chemotherapy, but there was a delay for HFS development and progression in silymarin group. Prophylactic administration of silymarin topical formulation could significantly reduce the severity of capecitabine-induced HFS and delays its occurrence in patients with gastrointestinal cancer after 9 weeks of application. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

A double blind randomised controlled clinical trial on the effect of transcutaneous spinal electroanalgesia (TSE) on low back pain.

PubMed

Thompson, John W; Bower, Susanne; Tyrer, Stephen P

2008-04-01

A double blind randomised controlled clinical trial on the effect of transcutaneous spinal electroanalgesia (TSE) on low back pain was carried out in 58 patients attending a Pain Management Unit. Four TSE instruments, two active and two sham, were used and each patient was assigned randomly to one of these. Low back pain was rated by each patient using a visual analogue scale (VAS) immediately before and immediately after a single 20 min treatment of TSE and also daily for the week prior to, and the week following, the treatment. No significant difference in mean pain score was detected between the active and sham treated groups immediately after treatment or during the subsequent week. The Hospital, Anxiety and Depression scale (HAD) and the General Health Questionnaire (GHQ) were completed by each patient and there was a positive correlation between the scores achieved on these scales and the mean pain scores in both the active and sham treated groups. A post-trial problem was the discovery that the specification of the two active TSE machines differed from the manufacturer's specification. Thus, the output frequencies were either more (+10%) or less (-17%) while the maximum output voltages were both less (-40% and -20%), respectively. However, additional statistical analysis revealed no significant differences between the results obtained with the two active machines.

Enriched Air Nitrox Breathing Reduces Venous Gas Bubbles after Simulated SCUBA Diving: A Double-Blind Cross-Over Randomized Trial.

PubMed

Souday, Vincent; Koning, Nick J; Perez, Bruno; Grelon, Fabien; Mercat, Alain; Boer, Christa; Seegers, Valérie; Radermacher, Peter; Asfar, Pierre

2016-01-01

To test the hypothesis whether enriched air nitrox (EAN) breathing during simulated diving reduces decompression stress when compared to compressed air breathing as assessed by intravascular bubble formation after decompression. Human volunteers underwent a first simulated dive breathing compressed air to include subjects prone to post-decompression venous gas bubbling. Twelve subjects prone to bubbling underwent a double-blind, randomized, cross-over trial including one simulated dive breathing compressed air, and one dive breathing EAN (36% O2) in a hyperbaric chamber, with identical diving profiles (28 msw for 55 minutes). Intravascular bubble formation was assessed after decompression using pulmonary artery pulsed Doppler. Twelve subjects showing high bubble production were included for the cross-over trial, and all completed the experimental protocol. In the randomized protocol, EAN significantly reduced the bubble score at all time points (cumulative bubble scores: 1 [0-3.5] vs. 8 [4.5-10]; P < 0.001). Three decompression incidents, all presenting as cutaneous itching, occurred in the air versus zero in the EAN group (P = 0.217). Weak correlations were observed between bubble scores and age or body mass index, respectively. EAN breathing markedly reduces venous gas bubble emboli after decompression in volunteers selected for susceptibility for intravascular bubble formation. When using similar diving profiles and avoiding oxygen toxicity limits, EAN increases safety of diving as compared to compressed air breathing. ISRCTN 31681480.

A Double-Blind Placebo-Controlled Trial of Maca Root as Treatment for Antidepressant-Induced Sexual Dysfunction in Women

PubMed Central

Dording, Christina M.; Schettler, Pamela J.; Dalton, Elizabeth D.; Parkin, Susannah R.; Walker, Rosemary S. W.; Fehling, Kara B.; Fava, Maurizio

2015-01-01

Objective. We sought to demonstrate that maca root may be an effective treatment for antidepressant-induced sexual dysfunction (AISD) in women. Method. We conducted a 12-week, double-blind, placebo-controlled trial of maca root (3.0 g/day) in 45 female outpatients (mean age of 41.5 ± 12.5 years) with SSRI/SNRI-induced sexual dysfunction whose depression remitted. Endpoints were improvement in sexual functioning as per the Arizona Sexual Experience Scale (ASEX) and the Massachusetts General Hospital Sexual Function Questionnaire (MGH-SFQ). Results. 45 of 57 consented females were randomized, and 42 (30 premenopausal and 12 postmenopausal women) were eligible for a modified intent-to-treat analysis based on having had at least one postmedication visit. Remission rates by the end of treatment were higher for the maca than the placebo group, based on attainment of an ASEX total score ≤ 10 (9.5% for maca versus 4.8% for placebo), attaining an MGH-SFQ score ≤ 12 (30.0% for maca versus 20.0% for placebo) and reaching an MGH-SFQ score ≤ 8 (9.5% for maca versus 5.0% for placebo). Higher remission rates for the maca versus placebo group were associated with postmenopausal status. Maca was well tolerated. Conclusion. Maca root may alleviate SSRI-induced sexual dysfunction in postmenopausal women. This trial is registered with NCT00568126. PMID:25954318

Effects of Saffron on Cognition, Anxiety, and Depression in Patients Undergoing Coronary Artery Bypass Grafting: A Randomized Double-Blind Placebo-Controlled Trial.

PubMed

Moazen-Zadeh, Ehsan; Abbasi, Seyed Hesameddin; Safi-Aghdam, Hamideh; Shahmansouri, Nazila; Arjmandi-Beglar, Akram; Hajhosseinn Talasaz, Azita; Salehiomran, Abbas; Forghani, Saeedeh; Akhondzadeh, Shahin

2018-04-01

Cognitive decline, depression, and anxiety are among the major concerns in patients undergoing coronary artery bypass grafting (CABG). Crocus sativus L. (saffron) seems to be a promising candidate for treatment of these conditions. In this 12-week, randomized, double-blind, placebo-controlled clinical trial, men and women with on-pump CABG, who had Wechsler Memory Scale (WMS) score >70 and age <70 years, received either saffron capsules (15 mg/twice daily) or placebo. Patients were excluded if they had history of treatment with saffron or acetylcholinesterase inhibitors, comorbid neuropsychiatric disorders, serious medical conditions other than cardiovascular diseases, and hypersensitivity to herbal compounds. The primary outcome was defined as the difference in mean total score changes for WMS-Revised from the baseline to week 12 between the saffron and placebo groups. Secondary outcomes included difference in mean score changes from baseline to endpoint between the two treatment groups for Mini Mental Status Examination and subscales of Hospital Anxiety and Depression Scale ( www.irct.ir ; IRCT201408071556N63). No significant difference was detected in primary or secondary outcomes between the saffron and placebo groups. Also, no significant time × treatment interaction effect was found for any of the scales. The results of this trial do not support the hypothesis of potential benefits of saffron in treatment of CABG-related neuropsychiatric conditions.

D3R Grand Challenge 2: blind prediction of protein-ligand poses, affinity rankings, and relative binding free energies

NASA Astrophysics Data System (ADS)

Gaieb, Zied; Liu, Shuai; Gathiaka, Symon; Chiu, Michael; Yang, Huanwang; Shao, Chenghua; Feher, Victoria A.; Walters, W. Patrick; Kuhn, Bernd; Rudolph, Markus G.; Burley, Stephen K.; Gilson, Michael K.; Amaro, Rommie E.

2018-01-01

The Drug Design Data Resource (D3R) ran Grand Challenge 2 (GC2) from September 2016 through February 2017. This challenge was based on a dataset of structures and affinities for the nuclear receptor farnesoid X receptor (FXR), contributed by F. Hoffmann-La Roche. The dataset contained 102 IC50 values, spanning six orders of magnitude, and 36 high-resolution co-crystal structures with representatives of four major ligand classes. Strong global participation was evident, with 49 participants submitting 262 prediction submission packages in total. Procedurally, GC2 mimicked Grand Challenge 2015 (GC2015), with a Stage 1 subchallenge testing ligand pose prediction methods and ranking and scoring methods, and a Stage 2 subchallenge testing only ligand ranking and scoring methods after the release of all blinded co-crystal structures. Two smaller curated sets of 18 and 15 ligands were developed to test alchemical free energy methods. This overview summarizes all aspects of GC2, including the dataset details, challenge procedures, and participant results. We also consider implications for progress in the field, while highlighting methodological areas that merit continued development. Similar to GC2015, the outcome of GC2 underscores the pressing need for methods development in pose prediction, particularly for ligand scaffolds not currently represented in the Protein Data Bank (http://www.pdb.org), and in affinity ranking and scoring of bound ligands.

Evaluation of an ultra-low-dose oral contraceptive for dysmenorrhea: a placebo-controlled, double-blind, randomized trial.

PubMed

Harada, Tasuku; Momoeda, Mikio

2016-12-01

To evaluate the efficacy and safety of an ultra-low-dose oral contraceptive (NPC-01; 0.02 mg ethinyl estradiol and 1 mg norethisterone) in subjects with dysmenorrhea. Placebo-controlled, double-blind, randomized trial. Clinical trial sites. Two hundred fifteen subjects with dysmenorrhea. Subjects were randomly assigned to receive NPC-01, placebo, or IKH-01 (0.035 mg ethinyl estradiol and 1 mg norethisterone) for four cycles. Total dysmenorrhea score (verbal rating scale) assessing pain on the basis of limited ability to work and need for analgesics. The reductions of total dysmenorrhea score and visual analog scale score after the treatment were significantly higher in the NPC-01 group than in the placebo group. Furthermore, the efficacy of NPC-01 was comparable to that of IKH-01. The overall incidence of side effects was significantly higher in the NPC-01 group than in the placebo group. All side effects that occurred in the NPC-01 group were previously reported in patients receiving IKH-01. No serious side effects occurred. The ultra-low-dose contraceptive NPC-01 relieved dysmenorrhea as effectively as IKH-01. Thus, NPC-01 could represent a new option for long-term treatment of dysmenorrhea. NCT01129102. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Using a computer simulation for teaching communication skills: A blinded multisite mixed methods randomized controlled trial.

PubMed

Kron, Frederick W; Fetters, Michael D; Scerbo, Mark W; White, Casey B; Lypson, Monica L; Padilla, Miguel A; Gliva-McConvey, Gayle A; Belfore, Lee A; West, Temple; Wallace, Amelia M; Guetterman, Timothy C; Schleicher, Lauren S; Kennedy, Rebecca A; Mangrulkar, Rajesh S; Cleary, James F; Marsella, Stacy C; Becker, Daniel M

2017-04-01

To assess advanced communication skills among second-year medical students exposed either to a computer simulation (MPathic-VR) featuring virtual humans, or to a multimedia computer-based learning module, and to understand each group's experiences and learning preferences. A single-blinded, mixed methods, randomized, multisite trial compared MPathic-VR (N=210) to computer-based learning (N=211). Primary outcomes: communication scores during repeat interactions with MPathic-VR's intercultural and interprofessional communication scenarios and scores on a subsequent advanced communication skills objective structured clinical examination (OSCE). Multivariate analysis of variance was used to compare outcomes. student attitude surveys and qualitative assessments of their experiences with MPathic-VR or computer-based learning. MPathic-VR-trained students improved their intercultural and interprofessional communication performance between their first and second interactions with each scenario. They also achieved significantly higher composite scores on the OSCE than computer-based learning-trained students. Attitudes and experiences were more positive among students trained with MPathic-VR, who valued its providing immediate feedback, teaching nonverbal communication skills, and preparing them for emotion-charged patient encounters. MPathic-VR was effective in training advanced communication skills and in enabling knowledge transfer into a more realistic clinical situation. MPathic-VR's virtual human simulation offers an effective and engaging means of advanced communication training. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Using a computer simulation for teaching communication skills: A blinded multisite mixed methods randomized controlled trial

PubMed Central

Kron, Frederick W.; Fetters, Michael D.; Scerbo, Mark W.; White, Casey B.; Lypson, Monica L.; Padilla, Miguel A.; Gliva-McConvey, Gayle A.; Belfore, Lee A.; West, Temple; Wallace, Amelia M.; Guetterman, Timothy C.; Schleicher, Lauren S.; Kennedy, Rebecca A.; Mangrulkar, Rajesh S.; Cleary, James F.; Marsella, Stacy C.; Becker, Daniel M.

2016-01-01

Objectives To assess advanced communication skills among second-year medical students exposed either to a computer simulation (MPathic-VR) featuring virtual humans, or to a multimedia computer-based learning module, and to understand each group’s experiences and learning preferences. Methods A single-blinded, mixed methods, randomized, multisite trial compared MPathic-VR (N=210) to computer-based learning (N=211). Primary outcomes: communication scores during repeat interactions with MPathic-VR’s intercultural and interprofessional communication scenarios and scores on a subsequent advanced communication skills objective structured clinical examination (OSCE). Multivariate analysis of variance was used to compare outcomes. Secondary outcomes: student attitude surveys and qualitative assessments of their experiences with MPathic-VR or computer-based learning. Results MPathic-VR-trained students improved their intercultural and interprofessional communication performance between their first and second interactions with each scenario. They also achieved significantly higher composite scores on the OSCE than computer-based learning-trained students. Attitudes and experiences were more positive among students trained with MPathic-VR, who valued its providing immediate feedback, teaching nonverbal communication skills, and preparing them for emotion-charged patient encounters. Conclusions MPathic-VR was effective in training advanced communication skills and in enabling knowledge transfer into a more realistic clinical situation. Practice Implications MPathic-VR’s virtual human simulation offers an effective and engaging means of advanced communication training. PMID:27939846

Enzyme potentiated desensitisation in treatment of seasonal allergic rhinitis: double blind randomised controlled study

PubMed Central

Radcliffe, Michael J; Lewith, George T; Turner, Richard G; Prescott, Philip; Church, Martin K; Holgate, Stephen T

2003-01-01

Objective To assess the efficacy of enzyme potentiated desensitisation in the treatment of severe summer hay fever poorly controlled by pharmacotherapy. Design Double blind randomised placebo controlled parallel group study. Setting Hospital in Hampshire. Participants 183 participants aged between 18 and 64 with a history of severe summer hay fever for at least two years; all were skin prick test positive to timothy grass pollen. 90 randomised to active treatment; 93 randomised to placebo. Interventions Active treatment: two injections of enzyme potentiated desensitisation, given between eight and 11 weeks apart, each comprising 200 Fishman units of β glucuronidase, 50 pg 1,3-cyclohexanediol, 50 ng protamine sulphate, and a mixed inhaled allergen extract (pollen mixes for trees, grasses, and weeds; allergenic fungal spores; cat and dog danders; dust and storage mites) in a total volume of 0.05 ml of buffered saline. Placebo: two injections of 0.05 ml buffered saline solution. Main outcome measures Proportion of problem-free days; global rhinoconjunctivitis quality of life scores assessed weekly during pollen season. Results The active treatment group and the placebo group did not differ in the proportion of problem-free days, quality of life scores, symptom severity scores, change in quantitative skin prick provocation threshold, or change in conjunctival provocation threshold. No clinically significant adverse reactions occurred. Conclusions Enzyme potentiated desensitisation showed no treatment effect in this study. PMID:12896934

High energy focused shock wave therapy accelerates bone healing. A blinded, prospective, randomized canine clinical trial.

PubMed

Kieves, N R; MacKay, C S; Adducci, K; Rao, S; Goh, C; Palmer, R H; Duerr, F M

2015-01-01

To evaluate the influence of shock wave therapy (SWT) on radiographic evidence of bone healing after tibial plateau leveling osteotomy (TPLO). Healthy dogs between two to nine years of age that underwent TPLO were randomly assigned to receive either electro-hydraulic SWT (1,000 shocks) or sham treatment (SHAM). Treatment or SHAM was administered to the osteotomy site immediately postoperatively and two weeks postoperatively. Three blinded radiologists evaluated orthogonal radiographs performed eight weeks postoperatively with both a 5-point and a 10-point bone healing scale. Linear regression analysis was used to compare median healing scores between groups. Forty-two dogs (50 stifles) were included in the statistical analysis. No major complications were observed and all osteotomies healed uneventfully. The median healing scores were significantly higher at eight weeks postoperatively for the SWT group compared to the SHAM group for the 10-point (p <0.0002) and 5-point scoring systems (p <0.0001). Shock wave therapy applied immediately and two weeks postoperatively led to more advanced bone healing at the eight week time point in this study population. The results of this study support the use of electro-hydraulic SWT as a means of accelerating acute bone healing of canine osteotomies. Additional studies are needed to evaluate its use for acceleration of bone healing following fracture, or with delayed union.

Comparison of manual sleep staging with automated neural network-based analysis in clinical practice.

PubMed

Caffarel, Jennifer; Gibson, G John; Harrison, J Phil; Griffiths, Clive J; Drinnan, Michael J

2006-03-01

We have compared sleep staging by an automated neural network (ANN) system, BioSleep (Oxford BioSignals) and a human scorer using the Rechtschaffen and Kales scoring system. Sleep study recordings from 114 patients with suspected obstructed sleep apnoea syndrome (OSA) were analysed by ANN and by a blinded human scorer. We also examined human scorer reliability by calculating the agreement between the index scorer and a second independent blinded scorer for 28 of the 114 studies. For each study, we built contingency tables on an epoch-by-epoch (30 s epochs) comparison basis. From these, we derived kappa (kappa) coefficients for different combinations of sleep stages. The overall agreement of automatic and manual scoring for the 114 studies for the classification {wake / light-sleep / deep-sleep / REM} was poor (median kappa = 0.305) and only a little better (kappa = 0.449) for the crude {wake / sleep} distinction. For the subgroup of 28 randomly selected studies, the overall agreement of automatic and manual scoring was again relatively low (kappa = 0.331 for {wake light-sleep / deep-sleep REM} and kappa = 0.505 for {wake / sleep}), whereas inter-scorer reliability was higher (kappa = -0.641 for {wake / light-sleep / deep-sleep / REM} and kappa = 0.737 for {wake / sleep}). We conclude that such an ANN-based analysis system is not sufficiently accurate for sleep study analyses using the R&K classification system.

An Automatic Networking and Routing Algorithm for Mesh Network in PLC System

NASA Astrophysics Data System (ADS)

Liu, Xiaosheng; Liu, Hao; Liu, Jiasheng; Xu, Dianguo

2017-05-01

Power line communication (PLC) is considered to be one of the best communication technologies in smart grid. However, the topology of low voltage distribution network is complex, meanwhile power line channel has characteristics of time varying and attenuation, which lead to the unreliability of power line communication. In this paper, an automatic networking and routing algorithm is introduced which can be adapted to the "blind state" topology. The results of simulation and test show that the scheme is feasible, the routing overhead is small, and the load balance performance is good, which can achieve the establishment and maintenance of network quickly and effectively. The scheme is of great significance to improve the reliability of PLC.

Prediction of significant conduction disease through noninvasive assessment of cardiac calcification.

PubMed

Mainigi, Sumeet K; Chebrolu, Lakshmi Hima Bindu; Romero-Corral, Abel; Mehta, Vinay; Machado, Rodolfo Rozindo; Konecny, Tomas; Pressman, Gregg S

2012-10-01

Cardiac calcification is associated with coronary artery disease, arrhythmias, conduction disease, and adverse cardiac events. Recently, we have described an echocardiographic-based global cardiac calcification scoring system. The objective of this study was to evaluate the severity of cardiac calcification in patients with permanent pacemakers as based on this scoring system. Patients with a pacemaker implanted within the 2-year study period with a previous echocardiogram were identified and underwent blinded global cardiac calcium scoring. These patients were compared to matched control patients without a pacemaker who also underwent calcium scoring. The study group consisted of 49 patients with pacemaker implantation who were compared to 100 matched control patients. The mean calcium score in the pacemaker group was 3.3 ± 2.9 versus 1.8 ± 2.0 (P = 0.006) in the control group. Univariate and multivariate analysis revealed glomerular filtration rate and calcium scoring to be significant predictors of the presence of a pacemaker. Echocardiographic-based calcium scoring correlates with the presence of severe conduction disease requiring a pacemaker. © 2012, Wiley Periodicals, Inc.

A blind caries and fluorosis prevalence study of school-children in naturally fluoridated and nonfluoridated townships of Morayshire, Scotland.

PubMed

Stephen, Kenneth W; Macpherson, Lorna M D; Gilmour, W Harper; Stuart, Russell A M; Merrett, Martyn C W

2002-02-01

To undertake a blind caries and fluorosis prevalence study of Grade 1 (aged 5/6 yr) and Grade 4-7 (aged 8-12 yr) children from naturally water-fluoridated (1 ppm, since 1985) Burghead, Findhorn & Kinloss (F), and nearby nonfluoridated Buckie & Portessie (N-F), in rural Morayshire, Scotland. A blind clinical (+ 10% repeats) caries study of the above townships' 5/6-yr-old lifetime (15 F; 43 N-F), and 8-12-yr-old lifetime (55 F; 136 N-F)/school-lifetime (31 F; 37 N-F) residents was undertaken following bussing of these children to a common examination site in close-by Elgin Town Hall. Initially, each child was asked about their own perception of the aesthetics of their maxillary front teeth. Fluorosis was assessed clinically using the TF Index, as well as photographically - for later blind scoring (+ 10% repeats for lifetime 8-12-yr-olds) of slides by four dental and two lay 'jurors', alongside a now-established UK 'bench-mark' mildly mottled (TFI = 2), fluorosis comparator slide, judged in previous studies to be aesthetically lay-acceptable. In addition, by parental questionnaire, information was sought concerning their child's fluoride supplement and dentifrice usage histories. For 5/6-yr-olds, mean primary caries scores were 96.0% less in fluoridated than nonfluoridated subjects (P < 0.01). In 8-12-yr-olds, DMFT values favoured water-fluoridated subjects; their caries-free trend was significant (P < 0.001 overall). Clinically, 33% of all lifetime F subjects and 18% of all N-F pupils had fluorosed maxillary anterior teeth (P = 0.045), but no statistically significant difference was found between the 7% F and 3% N-F subjects with TFI scores > 2 (P = 0.25). Photographically, 'jury' mottling assessment (+ 10% repeats) of projected slides resulted in at least 1 : 6 positive scores in 43.6% of F and 30.9% of N-F pupils, albeit they unanimously scored only nine F and five N-F children as having fluorosed teeth (P < 0.01). In no case did all members score TFI > 2. Dental and lay scorers rated TFI = (1/2) in only a further 9.1% and 5.5% of F subjects, respectively, compared to 0.7% and 1.5% respectively of N-F pupils. Again, TFI > 2 was scored unanimously in no child. No differences were found regarding the children's own degree of anterior tooth aesthetic nonacceptability between F (11%) and N-F (12%) prevalence (P = 0.75). Finally, only one F child had taken F supplements and, while 26 N-F had used F drops, no significant relationship was found between their usage and TFI values in the latter group (P = 0.49). Additionally, no relationship was noted between clinical TFI scores and the age at which parents stated fluoridated dentifrice toothbrushing commenced, between 0 and 24 + months of age. Considerable caries benefit has accrued to those Morayshire rural children who have received naturally fluoridated water (at 1 ppm) throughout their lives, as compared to their socioeconomically similar, nonfluoridated rural counterparts. Furthermore, in spite of all but two subjects claiming to have brushed regularly with fluoridated dentifrice (and no evidence of the availability of nonfluoridated toothpaste being purchasable in the five townships), only borderline mild fluorosis disadvantages have been noted clinically, and none by the subjects' own aesthetic perceptions. Finally, no evidence was found to suggest any delay in permanent tooth eruption patterns of the F subjects. It would seem appropriate therefore, that adjustment of Scots' drinking waters' natural fluoride levels to 1 ppm should be pursued to extend similar dental advantages to the vast majority of that population (both young and old) which, it is well documented, has the worst dental health of mainland UK.

Quantification of myocardial fibrosis by digital image analysis and interactive stereology

PubMed Central

2014-01-01

Background Cardiac fibrosis disrupts the normal myocardial structure and has a direct impact on heart function and survival. Despite already available digital methods, the pathologist’s visual score is still widely considered as ground truth and used as a primary method in histomorphometric evaluations. The aim of this study was to compare the accuracy of digital image analysis tools and the pathologist’s visual scoring for evaluating fibrosis in human myocardial biopsies, based on reference data obtained by point counting performed on the same images. Methods Endomyocardial biopsy material from 38 patients diagnosed with inflammatory dilated cardiomyopathy was used. The extent of total cardiac fibrosis was assessed by image analysis on Masson’s trichrome-stained tissue specimens using automated Colocalization and Genie software, by Stereology grid count and manually by Pathologist’s visual score. Results A total of 116 slides were analyzed. The mean results obtained by the Colocalization software (13.72 ± 12.24%) were closest to the reference value of stereology (RVS), while the Genie software and Pathologist score gave a slight underestimation. RVS values correlated strongly with values obtained using the Colocalization and Genie (r > 0.9, p < 0.001) software as well as the pathologist visual score. Differences in fibrosis quantification by Colocalization and RVS were statistically insignificant. However, significant bias was found in the results obtained by using Genie versus RVS and pathologist score versus RVS with mean difference values of: -1.61% and 2.24%. Bland-Altman plots showed a bidirectional bias dependent on the magnitude of the measurement: Colocalization software overestimated the area fraction of fibrosis in the lower end, and underestimated in the higher end of the RVS values. Meanwhile, Genie software as well as the pathologist score showed more uniform results throughout the values, with a slight underestimation in the mid-range for both. Conclusion Both applied digital image analysis methods revealed almost perfect correlation with the criterion standard obtained by stereology grid count and, in terms of accuracy, outperformed the pathologist’s visual score. Genie algorithm proved to be the method of choice with the only drawback of a slight underestimation bias, which is considered acceptable for both clinical and research evaluations. Virtual slides The virtual slide(s) for this article can be found here: http://www.diagnosticpathology.diagnomx.eu/vs/9857909611227193 PMID:24912374

Quantification of myocardial fibrosis by digital image analysis and interactive stereology.

PubMed

Daunoravicius, Dainius; Besusparis, Justinas; Zurauskas, Edvardas; Laurinaviciene, Aida; Bironaite, Daiva; Pankuweit, Sabine; Plancoulaine, Benoit; Herlin, Paulette; Bogomolovas, Julius; Grabauskiene, Virginija; Laurinavicius, Arvydas

2014-06-09

Cardiac fibrosis disrupts the normal myocardial structure and has a direct impact on heart function and survival. Despite already available digital methods, the pathologist's visual score is still widely considered as ground truth and used as a primary method in histomorphometric evaluations. The aim of this study was to compare the accuracy of digital image analysis tools and the pathologist's visual scoring for evaluating fibrosis in human myocardial biopsies, based on reference data obtained by point counting performed on the same images. Endomyocardial biopsy material from 38 patients diagnosed with inflammatory dilated cardiomyopathy was used. The extent of total cardiac fibrosis was assessed by image analysis on Masson's trichrome-stained tissue specimens using automated Colocalization and Genie software, by Stereology grid count and manually by Pathologist's visual score. A total of 116 slides were analyzed. The mean results obtained by the Colocalization software (13.72 ± 12.24%) were closest to the reference value of stereology (RVS), while the Genie software and Pathologist score gave a slight underestimation. RVS values correlated strongly with values obtained using the Colocalization and Genie (r>0.9, p<0.001) software as well as the pathologist visual score. Differences in fibrosis quantification by Colocalization and RVS were statistically insignificant. However, significant bias was found in the results obtained by using Genie versus RVS and pathologist score versus RVS with mean difference values of: -1.61% and 2.24%. Bland-Altman plots showed a bidirectional bias dependent on the magnitude of the measurement: Colocalization software overestimated the area fraction of fibrosis in the lower end, and underestimated in the higher end of the RVS values. Meanwhile, Genie software as well as the pathologist score showed more uniform results throughout the values, with a slight underestimation in the mid-range for both. Both applied digital image analysis methods revealed almost perfect correlation with the criterion standard obtained by stereology grid count and, in terms of accuracy, outperformed the pathologist's visual score. Genie algorithm proved to be the method of choice with the only drawback of a slight underestimation bias, which is considered acceptable for both clinical and research evaluations. The virtual slide(s) for this article can be found here: http://www.diagnosticpathology.diagnomx.eu/vs/9857909611227193.

Changes in vision related quality of life in patients with diabetic macular edema: ranibizumab or laser treatment?

PubMed

Turkoglu, Elif Betul; Celık, Erkan; Aksoy, Nilgun; Bursalı, Ozlem; Ucak, Turgay; Alagoz, Gursoy

2015-01-01

To compare the changes in vision related quality of life (VR-QoL) in patients with diabetic macular edema (DME) undergoing intravitreal ranibizumab (IVR) injection or focal/grid laser. In this prospective study, 70 patients with clinically significant macular edema (CSME) were randomized to undergo IVR injection (n=35) and focal/grid laser (n=35). If necessary, the laser or ranibizumab injections were repeated. Distance and near visual acuities, central retinal thickness (CRT) and The 25-item Visual Function Questionnaire (VFQ-25) were used to measure the effectiveness of treatments and VR-QoL before and after 6 months following IVR or laser treatment. The demographic and clinical findings before the treatments were similar in both main groups. The improvements in distance and near visual acuities were higher in IVR group than the laser group (p<0.01). The reduction in CRT in IVR group was higher than that in laser treatment group (p<0.01). In both groups, the VFQ-25 composite score tended to improve from baseline to 6 months. And at 6th month, the changes in composite score were significantly higher in IVR group than in laser group (p<0.05). The improvements in overall composite scores were 6.3 points for the IVR group compared with 3.0 points in the laser group. Patients treated with IVR and laser had large improvements in composite scores, general vision, near and distance visual acuities in VFQ-25 at 6 months, in comparison with baseline scores, and also mental health subscale in IVR group. Our study revealed that IVR improved not only visual acuity or CRT, but also vision related quality of life more than laser treatment in DME. And these patient-reported outcomes may play an important role in the treatment choice in DME for clinicians. Copyright © 2015 Elsevier Inc. All rights reserved.

Performance of e-ASPECTS software in comparison to that of stroke physicians on assessing CT scans of acute ischemic stroke patients.

PubMed

Herweh, Christian; Ringleb, Peter A; Rauch, Geraldine; Gerry, Steven; Behrens, Lars; Möhlenbruch, Markus; Gottorf, Rebecca; Richter, Daniel; Schieber, Simon; Nagel, Simon

2016-06-01

The Alberta Stroke Program Early CT score (ASPECTS) is an established 10-point quantitative topographic computed tomography scan score to assess early ischemic changes. We compared the performance of the e-ASPECTS software with those of stroke physicians at different professional levels. The baseline computed tomography scans of acute stroke patients, in whom computed tomography and diffusion-weighted imaging scans were obtained less than two hours apart, were retrospectively scored by e-ASPECTS as well as by three stroke experts and three neurology trainees blinded to any clinical information. The ground truth was defined as the ASPECTS on diffusion-weighted imaging scored by another two non-blinded independent experts on consensus basis. Sensitivity and specificity in an ASPECTS region-based and an ASPECTS score-based analysis as well as receiver-operating characteristic curves, Bland-Altman plots with mean score error, and Matthews correlation coefficients were calculated. Comparisons were made between the human scorers and e-ASPECTS with diffusion-weighted imaging being the ground truth. Two methods for clustered data were used to estimate sensitivity and specificity in the region-based analysis. In total, 34 patients were included and 680 (34 × 20) ASPECTS regions were scored. Mean time from onset to computed tomography was 172 ± 135 min and mean time difference between computed tomographyand magnetic resonance imaging was 41 ± 31 min. The region-based sensitivity (46.46% [CI: 30.8;62.1]) of e-ASPECTS was better than three trainees and one expert (p ≤ 0.01) and not statistically different from another two experts. Specificity (94.15% [CI: 91.7;96.6]) was lower than one expert and one trainee (p < 0.01) and not statistically different to the other four physicians. e-ASPECTS had the best Matthews correlation coefficient of 0.44 (experts: 0.38 ± 0.08 and trainees: 0.19 ± 0.05) and the lowest mean score error of 0.56 (experts: 1.44 ± 1.79 and trainees: 1.97 ± 2.12). e-ASPECTS showed a similar performance to that of stroke experts in the assessment of brain computed tomographys of acute ischemic stroke patients with the Alberta Stroke Program Early CT score method. © 2016 World Stroke Organization.

Prevalence of psychiatric morbidity in visually impaired children.

PubMed

Bakhla, Ajay Kumar; Sinha, Vinod Kumar; Verma, Vijay; Sarkhel, Sujit

2011-03-01

This study was done to measure psychiatric morbidity and associated sociodemographic variables among visually impaired children. 92 students of age range 6 to 20 years from four schools for the blind, in Ranchi, were screened with verbal Hindi translation of General Health Questionnaire 60. Diagnostic Interview Schedule Parent version was applied to establish psychiatric diagnosis on primary caretakers of those who scored above cutoff. Fourteen scored above cut off and psychiatric diagnoses of 8 children were established. The prevalence of psychiatric morbidity among visually impaired children was found to be 8.69% No sociodemographic variable was associated with the occurrence of psychiatric illness.

A Paired, Double-Blind, Randomized Comparison of a Moisturizing Durable Barrier Cream to 10% Glycerine Cream in the Prophylactic Management of Postmastectomy Irradiation Skin Care: Trans Tasman Radiation Oncology Group (TROG) 04.01

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

Graham, Peter H., E-mail: peter.graham@sesiahs.health.nsw.gov.au; Plant, Natalie; Graham, Jennifer L.

2013-05-01

Purpose: A previous, unblinded study demonstrated that an alcohol-free barrier film containing an acrylate terpolymer (ATP) was effective in reducing skin reactions compared with a 10% glycerine cream (sorbolene). The different appearances of these products precluded a blinded comparison. To test the acrylate terpolymer principle in a double-blinded manner required the use of an alternative cream formulation, a moisturizing durable barrier cream (MDBC); the study was conducted by the Trans Tasman Radiation Oncology Group (TROG) as protocol 04.01. Methods and Materials: A total of 333 patients were randomized; 1 patient was ineligible and 14 patients withdrew or had less thanmore » 7 weeks' observations, leaving 318 for analysis. The chest wall was divided into medial and lateral compartments, and patients were randomized to have MDBC applied daily to the medial or lateral compartment and sorbolene to the other compartment. Weekly observations, photographs, and symptom scores (pain and pruritus) were collected to week 12 or resolution of skin reactions if earlier. Skin dose was confirmed by centrally calibrated thermoluminescent dosimeters. Results: Rates of medial and lateral compartment Common Toxicity Criteria (CTC), version 3, greater than or equal to grade 3 skin reactions were 23% and 41%, but rates by skin care product were identical at 32%. There was no significant difference between MDBC and sorbolene in the primary endpoint of peak skin reactions or secondary endpoints of area-under-the-curve skin reaction scores. Conclusions: The MDBC did not reduce the peak skin reaction compared to sorbolene. It is possible that this is related to the difference in the formulation of the cream compared with the film formulation. Skin dosimetry verification and double blinding are essential for radiation skin care comparative studies.« less

Shear Wave Elastography (SWE) for Monitoring of Treatment of Tendinopathies: A Double-blinded, Longitudinal Clinical Study.

PubMed

Dirrichs, Timm; Quack, Valentin; Gatz, Matthias; Tingart, Markus; Rath, Björn; Betsch, Marcel; Kuhl, Christiane K; Schrading, Simone

2018-03-01

We aimed to investigate the diagnostic accuracy with which shear wave elastography (SWE) can be used to monitor response to treatment of tendinopathies, and to compare it to conventional ultrasound (US)-imaging methods (B-mode US (B-US) and power Doppler US (PD-US)). A prospective Institutional Review Board-approved longitudinal study on 35 patients with 47 symptomatic tendons (17 Achilles-, 15 patellar-, and 15 humeral-epicondylar) who underwent standardized multimodal US and standardized clinical assessment before and after 6 months of treatment (tailored stretching exercise, sport break, and local Polidocanol) was carried out. All US studies were performed by radiologists blinded to the clinical symptoms on both tendon sides to avoid biased interpretations, by B-US, PD-US, and SWE, conducted in the same order, using a high-resolution linear 15 MHz probe (Aixplorer). Orthopedic surgeons who were in turn blinded to US imaging results used established orthopedic scores (Victorian Institute of Sports Assessment questionnaire for Achilles, Victorian Institute of Sports Assessment questionnaire for patellar tendons, and Disability Arm Shoulder Hand scoring system) to rate presence, degree, and possible resolution of symptoms. We analyzed the diagnostic accuracy with which the different US imaging methods were able to detect symptomatic tendons at baseline as well as treatment effects, with orthopedic scores serving as reference standard. B-US, PD-US, and SWE detected symptomatic tendons with a sensitivity of 66% (31 of 47), 72% (34 of 47), and 87.5% (41 of 47), respectively. Positive predictive value was 0.67 for B-US, 0.87 for PD-US, and 1 for SWE. After treatment, clinical scores improved in 68% (32 of 47) of tendons. Treatment effects were observable by B-US, PD-US, and SWE with a sensitivity of 3.1% (1 of 32), 28.1% (9 of 32), and 81.3% (26 of 32), respectively. B-US was false-positive in 68.8% (20 of 32), PD-US in 46.9% (15 of 32), and SWE in 12.5% (4 of 32) (SWE). Clinical scores and B-US, PD-US, and SWE findings correlated poorly (r = 0.24), moderately (r = 0.59), and strongly (r = 0.80). Unlike B-US or PD-US, SWE is able to depict processes associated with tendon healing and may be a useful tool to monitor treatment effects. Copyright © 2018 The Association of University Radiologists. Published by Elsevier Inc. All rights reserved.

Effects of conjugated linoleic acid and high oleic acid safflower oil in the treatment of children with HPV-induced laryngeal papillomatosis: a randomized, double-blinded and crossover preliminary study

PubMed Central

2012-01-01

Background Surgery is the mainstay therapy for HPV-induced laryngeal papillomatosis (LP) and adjuvant therapies are palliative at best. Research revealed that conjugated-linoleic acid (CLA) may improve the outcome of virally-induced diseases. The effects of Clarinol™ G-80 (CLA) and high oleic safflower oil (HOSF) on children with LP (concomitant with surgery) were evaluated. Design A randomized, double-blinded, crossover and reference-oil controlled trial was conducted at a South African medical university. Study components included clinical, HPV type/load and lymphocyte/cytokine analyses, according to routine laboratory methods. Participants Overall: ten children enrolled; eight completed the trial; five remained randomized; seven received CLA first; all treatments remained double-blinded. Intervention Children (4 to 12 years) received 2.5 ml p/d CLA (8 weeks) and 2.5 ml p/d HOSF (8 weeks) with a washout period (6 weeks) in-between. The one-year trial included a post-treatment period (30 weeks) and afterwards was a one-year follow-up period. Main outcome measures Changes in numbers of surgical procedures for improved disease outcome, total/anatomical scores (staging system) for papillomatosis prevention/viral inhibition, and lymphocyte/cytokine counts for immune responses between baselines and each treatment/end of trial were measured. Findings After each treatment all the children were in remission (no surgical procedures); after the trial two had recurrence (surgical procedures in post-treatment period); after the follow-up period three had recurrence (several surgical procedures) and five recovered (four had no surgical procedures). Effects of CLA (and HOSF to a lesser extent) were restricted to mildly/moderately aggressive papillomatosis. Children with low total scores (seven/less) and reduced infections (three/less laryngeal sub-sites) recovered after the trial. No harmful effects were observed. The number of surgical procedures during the trial (n6/available records) was significantly lower [(p 0.03) (95% CI 1.1; 0)]. Changes in scores between baselines and CLA treatments (n8) were significantly lower: total scores [(p 0.02) (95% CI −30.00; 0.00)]; anatomical scores [(p 0.008) (95% CI −33.00: -2.00)]. Immune enhancement could not be demonstrated. Conclusions These preliminary case and group findings pave the way for further research on the therapeutic potential of adjuvant CLA in the treatment of HPV-induced LP. PMID:23061633

The vasopressin V(1b) receptor antagonist SSR149415 in the treatment of major depressive and generalized anxiety disorders: results from 4 randomized, double-blind, placebo-controlled studies.

PubMed

Griebel, Guy; Beeské, Sandra; Stahl, Stephen M

2012-11-01

These studies were designed to evaluate the efficacy and tolerability of the first nonpeptide vasopressin V(1b) receptor antagonist, SSR149415, in the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD). Studies were randomized 8-week, double-blind, placebo-controlled trials evaluating 100- and 250-mg twice daily doses of SSR149415, placebo, and escitalopram 10 mg/day or paroxetine 20 mg/day, conducted from August 2006 through February 2008. Participants met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision criteria for MDD or GAD. Baseline Montgomery-Asberg Depression Rating Scale (MADRS) and Hamilton Depression Rating Scale (HDRS) total scores were ≥ 24 and 18, respectively, and in the GAD trial baseline Hamilton Anxiety Rating Scale (HARS) score was ≥ 22. Primary efficacy variables included changes from baseline in total score on HDRS or HARS and MADRS, and the secondary variable included changes in the Clinical Global Impressions-Severity of Illness score (CGI-S). A 4-week, double-blind, placebo-controlled study evaluating the effect of 100- and 250-mg twice daily doses of SSR149415 on the hypothalamic-pituitary-adrenal (HPA) axis in MDD patients was also conducted. In the GAD trial, SSR149415 did not separate from placebo on the primary (HARS-100 mg: P = .29; 250 mg: P = .21) and secondary (CGI-S-100 mg: P = .18; 250 mg: P = .24) outcome measures, while paroxetine demonstrated efficacy (HARS: P = .003; CGI-S: P = .01). In 2 MDD trials, SSR149415-treated patients did not show significant improvement from baseline on any outcome measure compared with placebo-treated patients (HDRS-100 mg: P = .21 and .48, respectively; 250 mg: P = .22 and P = .46, respectively; CGI-S-100 mg: P = .64 and P = .82, respectively; 250 mg: P = .33 and P = .08, respectively). In the third MDD study, SSR149415 250 mg (P = .04), but not escitalopram (P = .15), demonstrated significant improvement compared to placebo on the HDRS total score at week 8. SSR149415 had no deleterious effects on the HPA axis. These studies demonstrate that SSR149415 may not be useful for the treatment of GAD and that its antidepressant potential needs to be further evaluated. ClinicalTrials.gov identifiers: NCT00374166 (Sanofi ID number: DFI5880), NCT00361491 (Sanofi ID number: DFI5879), NCT00358631 (Sanofi ID number: DFI5878), NCT01606384 (Sanofi ID number: PDY5467). © Copyright 2012 Physicians Postgraduate Press, Inc.

12 CFR Appendix B to Part 30 - Interagency Guidelines Establishing Information Security Standards

Code of Federal Regulations, 2012 CFR

2012-01-01

... risks. C. Manage and Control Risk. Each bank shall: 1. Design its information security program to... A. Involve the Board of Directors B. Assess Risk C. Manage and Control Risk D. Oversee Service...) Aggregate information, such as the mean credit score, derived from a group of consumer reports; or (B) Blind...

12 CFR Appendix B to Part 30 - Interagency Guidelines Establishing Information Security Standards

Code of Federal Regulations, 2010 CFR

2010-01-01

... risks. C. Manage and Control Risk. Each bank shall: 1. Design its information security program to... A. Involve the Board of Directors B. Assess Risk C. Manage and Control Risk D. Oversee Service...) Aggregate information, such as the mean credit score, derived from a group of consumer reports; or (B) Blind...

Relations among Cognitive Styles and Reading Readiness in Preschoolers.

ERIC Educational Resources Information Center

Demick, Jack; Koerber, Heather J.

This study assessed the relationship between cognitive style and reading readiness, and examined effects of age and gender on measures of cognitive style and reading readiness. Subjects were 33 males and 27 females between 4 and 7 years of age. All subjects scored within the average range of intellectual functioning and were not color blind.…

INCREASED VISUAL BEHAVIOR IN LOW VISION CHILDREN.

ERIC Educational Resources Information Center

BARRAGA, NATALIE

TEN PAIRS OF BLIND CHILDREN AGED SIX TO 13 YEARS WHO HAD SOME VISION WERE MATCHED BY PRETEST SCORES ON A TEST OF VISUAL DISCRIMINATION. A CRITERION GROUP, DESIGNATED THE PRINT COMPARISON GROUP, HAD SLIGHLY HIGHER RECORDED DISTANCE ACUITIES AND USED VISION AS THE PRIMARY MEANS OF LEARNING. PAIRS OF EXPERIMENTAL SUBJECTS DAILY RECEIVED 45 MINUTES OF…

Pre and post-amputation mobility of trans-tibial amputees: correlation to medical problems, age and mortality.

PubMed

Johnson, V J; Kondziela, S; Gottschalk, F

1995-12-01

This retrospective study compares pre and post-amputation mobility and the influence of age and associated medical problems. Data from the charts of 120 male patients who underwent unilateral trans-tibial (below-knee) amputation at the Dallas Veteran's Administration Hospital between June, 1983 and October, 1991, were collected and analyzed. Mobility was assessed with a six level scale developed by Volpicelli et al. (1983). The presence of cardiac disease, pulmonary disease (COPD), peripheral vascular disease (PVD), diabetes mellitus, degenerative joint disease, blindness, cerebral vascular accident (CVA), and age are correlated with changes in mobility after amputation. Older patients had more medical problems and lower post-amputation scores Individual medical problems did not influence mobility scores, but the presence of COPD and PVD lowered pre-amputation mobility scores. Cardiac disease and diabetes mellitus influenced post-amputation mobility scores by lowering them, either together or individually. Regardless of age, however, patients with more medical problems were poor ambulators. The cause of amputation per se did not influence mobility scores.

CFD-RANS prediction of individual exposure from continuous release of hazardous airborne materials in complex urban environments

NASA Astrophysics Data System (ADS)

Efthimiou, G. C.; Andronopoulos, S.; Bartzis, J. G.; Berbekar, E.; Harms, F.; Leitl, B.

2017-02-01

One of the key issues of recent research on the dispersion inside complex urban environments is the ability to predict individual exposure (maximum dosages) of an airborne material which is released continuously from a point source. The present work addresses the question whether the computational fluid dynamics (CFD)-Reynolds-averaged Navier-Stokes (RANS) methodology can be used to predict individual exposure for various exposure times. This is feasible by providing the two RANS concentration moments (mean and variance) and a turbulent time scale to a deterministic model. The whole effort is focused on the prediction of individual exposure inside a complex real urban area. The capabilities of the proposed methodology are validated against wind-tunnel data (CUTE experiment). The present simulations were performed 'blindly', i.e. the modeller had limited information for the inlet boundary conditions and the results were kept unknown until the end of the COST Action ES1006. Thus, a high uncertainty of the results was expected. The general performance of the methodology due to this 'blind' strategy is good. The validation metrics fulfil the acceptance criteria. The effect of the grid and the turbulence model on the model performance is examined.

Haptic Recreation of Elbow Spasticity

PubMed Central

Kim, Jonghyun; Damiano, Diane L.

2013-01-01

The aim of this paper is to develop a haptic device capable of presenting standardized recreation of elbow spasticity. Using the haptic device, clinicians will be able to repeatedly practice the assessment of spasticity without requiring patient involvement, and these practice opportunities will help improve accuracy and reliability of the assessment itself. Haptic elbow spasticity simulator (HESS) was designed and prototyped according to mechanical requirements to recreate the feel of elbow spasticity. Based on the data collected from subjects with elbow spasticity, a mathematical model representing elbow spasticity is proposed. As an attempt to differentiate the feel of each score in Modified Ashworth Scale (MAS), parameters of the model were obtained respectively for three different MAS scores 1, 1+, and 2. The implemented haptic recreation was evaluated by experienced clinicians who were asked to give MAS scores by manipulating the haptic device. The clinicians who participated in the study were blinded to each other’s scores and to the given models. They distinguished the three models and the MAS scores given to the recreated models matched 100% with the original MAS scores from the patients. PMID:22275660

Effect of the Medicinal Agaricus blazei Murill-Based Mushroom Extract, AndoSanTM, on Symptoms, Fatigue and Quality of Life in Patients with Crohn's Disease in a Randomized Single-Blinded Placebo Controlled Study.

PubMed

Therkelsen, Stig Palm; Hetland, Geir; Lyberg, Torstein; Lygren, Idar; Johnson, Egil

2016-01-01

Ingestion of AndoSanTM, based on the mushroom Agaricus blazei Murill, has previously shown an anti-inflammatory effect through reduction of pro-inflammatory cytokines in healthy individuals and patients with Crohn's disease (CD). In this randomized single-blinded placebo-controlled study we examined whether intake of AndoSanTM also resulted in clinical effects. 50 patients with symptomatic CD were randomized for oral daily consumption of AndoSanTM or placebo for a 21-day experimental period, in this per-protocol study. Patients reported validated scores for symptoms, fatigue and health related quality of life (HRQoL) at days 0, 14 and 21. Fecal calprotectin and general blood parameters were also analyzed. In the AndoSanTM group (n = 25) symptoms improved from baseline (day 0) to days 14 and 21, with respective mean scores (95% CI) of 5.52 (4.64-6.40), 4.48 (3.69-5.27) and 4.08 (3.22-4.94) (p<0,001). We found significant improvements in symptom score for both genders in the AndoSanTM group, and no significant changes in the placebo (n = 25) group. There were however no significant differences between the groups (p = 0.106), although a marginal effect in symptom score for men (p = 0.054). There were comparable improvements in physical, mental and total fatigue for both groups. HRQoL versus baseline were at day 21 improved for bodily pain and vitality in the AndoSanTM group and for vitality and social functioning in the placebo group. No crucial changes in general blood samples and fecal calprotectin were detected. The results from this single-blinded randomized clinical trial shows significant improvement on symptoms, for both genders, in the AndoSanTM group, but no significant differences between the study groups. The results on fatigue, HRQoL, fecal calprotectin and blood samples were quite similar compared with placebo. The patients did not report any harms or unintended effects of AndoSanTM. CD patients with mild to moderate symptoms may have beneficiary effects of AndoSanTM as a safe supplement in addition to conventional medication. ClinicalTrials.gov NCT01496053.

Effect of the Medicinal Agaricus blazei Murill-Based Mushroom Extract, AndoSanTM, on Symptoms, Fatigue and Quality of Life in Patients with Crohn’s Disease in a Randomized Single-Blinded Placebo Controlled Study

PubMed Central

Hetland, Geir; Lyberg, Torstein; Lygren, Idar; Johnson, Egil

2016-01-01

Background Ingestion of AndoSanTM, based on the mushroom Agaricus blazei Murill, has previously shown an anti-inflammatory effect through reduction of pro-inflammatory cytokines in healthy individuals and patients with Crohn’s disease (CD). In this randomized single-blinded placebo-controlled study we examined whether intake of AndoSanTM also resulted in clinical effects. Methods and Findings 50 patients with symptomatic CD were randomized for oral daily consumption of AndoSanTM or placebo for a 21-day experimental period, in this per-protocol study. Patients reported validated scores for symptoms, fatigue and health related quality of life (HRQoL) at days 0, 14 and 21. Fecal calprotectin and general blood parameters were also analyzed. In the AndoSanTM group (n = 25) symptoms improved from baseline (day 0) to days 14 and 21, with respective mean scores (95% CI) of 5.52 (4.64–6.40), 4.48 (3.69–5.27) and 4.08 (3.22–4.94) (p<0,001). We found significant improvements in symptom score for both genders in the AndoSanTM group, and no significant changes in the placebo (n = 25) group. There were however no significant differences between the groups (p = 0.106), although a marginal effect in symptom score for men (p = 0.054). There were comparable improvements in physical, mental and total fatigue for both groups. HRQoL versus baseline were at day 21 improved for bodily pain and vitality in the AndoSanTM group and for vitality and social functioning in the placebo group. No crucial changes in general blood samples and fecal calprotectin were detected. Conclusions The results from this single-blinded randomized clinical trial shows significant improvement on symptoms, for both genders, in the AndoSanTM group, but no significant differences between the study groups. The results on fatigue, HRQoL, fecal calprotectin and blood samples were quite similar compared with placebo. The patients did not report any harms or unintended effects of AndoSanTM. CD patients with mild to moderate symptoms may have beneficiary effects of AndoSanTM as a safe supplement in addition to conventional medication. Trial Registration ClinicalTrials.gov NCT01496053 PMID:27415795

Long-Term Effects of Safinamide on Mood Fluctuations in Parkinson's Disease.

PubMed

Cattaneo, Carlo; Müller, Thomas; Bonizzoni, Erminio; Lazzeri, Gabriele; Kottakis, Ioannis; Keywood, Charlotte

2017-01-01

Mood disorders are very frequent in Parkinson's Disease (PD), and their effective treatment is still a major unresolved issue: growing evidence suggests that glutamatergic system dysfunction is directly involved. Safinamide is a drug with an innovative mechanism of action, dopaminergic and non-dopaminergic, that includes the reversible inhibition of the monoamine oxidase-B (MAO-B) enzyme and the modulation of excessive glutamate release through the use- and state-dependent blockade of the sodium channels. To investigate the effects of safinamide on mood over two-year treatment in PD patients with motor fluctuations. This was a post-hoc analysis of the data from studies 016 and 018. The analysis focused on outcomes related to mood, namely: scores of the "Emotional well-being" domain of the Parkinson's Disease Questionnaire (PDQ-39), scores of the GRID Hamilton Rating Scale for Depression (GRID-HAMD) and the proportion of patients reporting depression as an adverse event over the entire treatment period. Safinamide, compared to placebo, significantly improved the PDQ-39 "Emotional well-being" domain after6-months (p = 0.0067) and 2 years (p = 0.0006), as well as the GRID-HAMD (p = 0.0408 after 6 months and p = 0.0027 after 2 years). Significantly fewer patients in the safinamide group, compared to placebo, experienced depression as adverse event (p = 0.0444 after 6 months and p = 0.0057 after 2 years). The favorable effect of safinamide on mood may be explained by the improvement in wearing off and by its modulation of glutamatergic hyperactivity and reversible MAO-B inhibition. Prospective studies are warranted to investigate this potential benefit.

Long-Term Effects of Safinamide on Mood Fluctuations in Parkinson’s Disease

PubMed Central

Cattaneo, Carlo; Müller, Thomas; Bonizzoni, Erminio; Lazzeri, Gabriele; Kottakis, Ioannis; Keywood, Charlotte

2017-01-01

Background: Mood disorders are very frequent in Parkinson’s Disease (PD), and their effective treatment is still a major unresolved issue: growing evidence suggests that glutamatergic system dysfunction is directly involved. Safinamide is a drug with an innovative mechanism of action, dopaminergic and non-dopaminergic, that includes the reversible inhibition of the monoamine oxidase-B (MAO-B) enzyme and the modulation of excessive glutamate release through the use- and state-dependent blockade of the sodium channels. Objective: To investigate the effects of safinamide on mood over two-year treatment in PD patients with motor fluctuations. Methods: This was a post-hoc analysis of the data from studies 016 and 018. The analysis focused on outcomes related to mood, namely: scores of the “Emotional well-being” domain of the Parkinson’s Disease Questionnaire (PDQ-39), scores of the GRID Hamilton Rating Scale for Depression (GRID-HAMD) and the proportion of patients reporting depression as an adverse event over the entire treatment period. Results: Safinamide, compared to placebo, significantly improved the PDQ-39 “Emotional well-being” domain after6-months (p = 0.0067) and 2 years (p = 0.0006), as well as the GRID-HAMD (p = 0.0408 after 6 months and p = 0.0027 after 2 years). Significantly fewer patients in the safinamide group, compared to placebo, experienced depression as adverse event (p = 0.0444 after 6 months and p = 0.0057 after 2 years). Conclusion: The favorable effect of safinamide on mood may be explained by the improvement in wearing off and by its modulation of glutamatergic hyperactivity and reversible MAO-B inhibition. Prospective studies are warranted to investigate this potential benefit. PMID:28777756

Precipitation From a Multiyear Database of Convection-Allowing WRF Simulations

NASA Astrophysics Data System (ADS)

Goines, D. C.; Kennedy, A. D.

2018-03-01

Convection-allowing models (CAMs) have become frequently used for operational forecasting and, more recently, have been utilized for general circulation model downscaling. CAM forecasts have typically been analyzed for a few case studies or over short time periods, but this limits the ability to judge the overall skill of deterministic simulations. Analysis over long time periods can yield a better understanding of systematic model error. Four years of warm season (April-August, 2010-2013)-simulated precipitation has been accumulated from two Weather Research and Forecasting (WRF) models with 4 km grid spacing. The simulations were provided by the National Center for Environmental Prediction (NCEP) and the National Severe Storms Laboratory (NSSL), each with different dynamic cores and parameterization schemes. These simulations are evaluated against the NCEP Stage-IV precipitation data set with similar 4 km grid spacing. The spatial distribution and diurnal cycle of precipitation in the central United States are analyzed using Hovmöller diagrams, grid point correlations, and traditional verification skill scoring (i.e., ETS; Equitable Threat Score). Although NCEP-WRF had a high positive error in total precipitation, spatial characteristics were similar to observations. For example, the spatial distribution of NCEP-WRF precipitation correlated better than NSSL-WRF for the Northern Plains. Hovmöller results exposed a delay in initiation and decay of diurnal precipitation by NCEP-WRF while both models had difficulty in reproducing the timing and location of propagating precipitation. ETS was highest for NSSL-WRF in all domains at all times. ETS was also higher in areas of propagating precipitation compared to areas of unorganized diurnal scattered precipitation. Monthly analysis identified unique differences between the two models in their abilities to correctly simulate the spatial distribution and zonal motion of precipitation through the warm season.

Effectiveness of Riluzole as a pharmacotherapeutic treatment option for early cervical myelopathy: a double-blinded, placebo-controlled randomised controlled trial.

PubMed

Rajasekaran, S; Aiyer, Siddharth N; Shetty, Ajoy Prasad; Kanna, Rishi Mugesh; Maheswaran, Anupama; Shetty, Janardhan Yerram

2016-06-01

To evaluate the effectiveness of Riluzole as a pharmacotherapeutic treatment option for early cervical myelopathy using clinical parameters and DTI analysis. Early cervical myelopathy cases with MJOA scores ≥13, were recruited for the double-blinded, placebo-controlled randomised control trial. Thirty cases with fifteen cases each in the test and placebo group were studied. Analysis was done using diffusion tensor imaging (DTI) and clinical evaluation, pre- and post-institution of sodium channel blocker Riluzole for a period of 1 month (50 mg twice daily). Placebo group was treated with Vitamin B complex tablets. Diffusion co-efficient fractional anisotrophy (FA), apparent diffusion co-efficient (ADC), volume ratio (VR), relative anisotrophy (RA) and Eigen vectors were calculated. Outcomes analysis was based on clinical scores of MJOA, Nurick grading, SF-12, NDI, and statistical analysis of DTI datametrics. The mean MJOA score was 15.6 (13-17) with no significant change in the test and control groups. The mean ADC, FA values were 1533.36 (1238-1779) and 494.36 (364-628) and changed to 1531.57 (1312-2091) and 484.86 (294-597), respectively, in the Riluzole group. However, the changes in the values of ADC, FA, and other co-efficients including VR, RA and eigenvectors in the two groups were not statistically significant. The functional scores in the SF-12 and NDI questionnaires did not change significantly. Our study did not show a significant change in the clinical outcome and DTI Indices with the use of Riluzole as a standalone pharmacotherapeutic agent for early cervical myelopathy. More studies may be needed to confirm the usefulness of Riluzole as a treatment option for cervical myelopathy.

A dual-task home-based rehabilitation programme for improving balance control in patients with acquired brain injury: a single-blind, randomized controlled pilot study.

PubMed

Peirone, Eliana; Goria, Paolo Filiberto; Anselmino, Arianna

2014-04-01

To evaluate the safety, feasibility and effectiveness of a dual-task home-based rehabilitation programme on balance impairments among adult patients with acquired brain injury. Single-blind, randomized controlled pilot study. Single rehabilitation centre. Sixteen participants between 12 and 18 months post-acquired brain injury with balance impairments and a score <10 seconds on the One-Leg Stance Test (eyes open). All participants received 50-minutes individualised traditional physiotherapy sessions three times a week for seven weeks. In addition, the intervention group (N = 8) performed an individualised dual-task home-based programme six days a week for seven weeks. The primary outcome measure was the Balance Evaluation System Test; secondary measures were the Activities-specific Balance Confidence Scale and Goal Attainment Scaling. At the end of the pilot study, the intervention group showed significantly greater improvement in Balance Evaluation System Test scores (17.87, SD 6.05) vs. the control group (5.5, SD 3.53; P = 0.008, r = 0.63). There was no significant difference in improvement in Activities-specific Balance Confidence Scale scores between the intervention group (25.25, SD 25.51) and the control group (7.00, SD 14.73; P = 0.11, r = 0.63). There was no significant improvement in Goal Attainment Scaling scores in the intervention (19.37, SD 9.03) vs. the control group (16.28, SD 6.58; P = 0.093, r = 0.63). This pilot study shows the safety, feasibility and short-term benefit of a dual-task home-based rehabilitation programme to improve balance control in patients with acquired brain injury. A sample size of 26 participants is required for a definitive study.

Anteromedial portal versus transtibial drilling techniques in ACL reconstruction: a blinded cross-sectional study at two- to five-year follow-up

PubMed Central

Alentorn-Geli, Eduard; Samitier, Gonzalo; Álvarez, Pedro; Steinbacher, Gilbert

2010-01-01

Drilling of the femoral tunnel with the transtibial (TT) technique is widely used in bone-patellar tendon-bone (BPTB) anterior cruciate ligament (ACL) reconstruction. Recent studies suggest higher knee stability with the use of the anteromedial portal (AMP). The purpose of this study was to compare functional and clinical outcomes of BPTB ACL reconstruction using the TT or the AMP technique for drilling the femoral tunnel. All ACL reconstructions between January 2003 and April 2006 were approached for eligibility. Forty-seven patients met inclusion criteria (21 TT group and 26 AMP group). Blinded assessments of IKDC score, knee stability and range of motion, one-leg hop test, mid-quadriceps circumference, VAS for satisfaction with surgery, Lysholm and Tegner scores, and SF-12 questionnaire were obtained for both groups. Data on preoperative and postoperative surgical timing were retrospectively reviewed through the charts. The AMP group demonstrated a significantly lower recovery time from surgery to walking without crutches (p < 0.01), to return to normal life (p < 0.03), to return jogging (p < 0.03), to return training (p < 0.03), and to return to play (p < 0.03). Knee stability values measured with KT-1000, Lachman test, pivot-shift sign, and objective IKDC score assessments were significantly better for the AMP compared to TT group (p < 0.002, p < 0.03, p < 0.02, p < 0.015, respectively). No differences were found for VAS for satisfaction with surgery, Lysholm, Tegner, and SF-12 between both groups. The use of the AMP technique significantly improved the anterior-posterior and rotational knee stability, IKDC scores, and recovery time from surgery compared to the TT technique. PMID:20401753

Effect of Perioperative Pregabalin on Postoperative Quality of Recovery in Patients Undergoing Off-Pump Coronary Artery Bypass Grafting (OPCABG): A Prospective, Randomized, Double-Blind Trial.

PubMed

Borde, Deepak Prakash; Futane, Savani Sameer; Asegaonkar, Balaji; Apsingekar, Pramod; Khade, Sujeet; Khodve, Bapu; Puranik, Manish; George, Antony; Joshi, Shreedhar

2017-08-01

Use of pregabalin is increasing in cardiac surgical patients. However, studies using comprehensive scoring systems are lacking on the drug's impact on postoperative recovery. The authors tested the hypothesis that perioperative oral pregabalin improves the postoperative quality of recovery as assessed using the Quality of Recovery (QoR-40) questionnaire in patients undergoing off-pump coronary artery bypass grafting (OPCABG). This was a randomized, double-blind, placebo-controlled study. Tertiary-care hospital. Patients undergoing OPCABG. Patients were assigned randomly to the following 2 groups: the pregabalin group (those who received pregabalin, 150 mg capsule orally, 1 hour before surgery and 2 days postoperatively [75 mg twice a day] starting after extubation; n = 37); and the control group (those who received 2 similar-looking multivitamin capsules at similar times; n = 34). The QoR-40 scores were noted preoperatively and 24 hours after extubation. Both groups were comparable in terms of preoperative patient characteristics and baseline QoR-40 scores. Global scores were significantly improved in the pregabalin group compared with the control group in the postoperative period (177±9 v 170±9; p = 0.002). QoR-40 values in the dimensions of emotional state (p = 0.005), physical comfort (p = 0.04), and pain (p = 0.02) were improved in the pregabalin group. Perioperative pregabalin improved postoperative quality of recovery as assessed using the QoR-40 questionnaire in patients undergoing OPCABG. Perioperative pregabalin offered advantages beyond better pain control, such as improved physical comfort and better emotional state; therefore, the drug's use in the perioperative period is recommended. Copyright © 2017 Elsevier Inc. All rights reserved.

Effect of vitamin D on gastrointestinal symptoms and health-related quality of life in irritable bowel syndrome patients: a randomized double-blind clinical trial.

PubMed

Abbasnezhad, A; Amani, R; Hajiani, E; Alavinejad, P; Cheraghian, B; Ghadiri, A

2016-10-01

Low-grade mucosal inflammation and immune activation are involved in the pathogenesis of irritable bowel syndrome (IBS). Furthermore, IBS symptoms are associated with a significantly higher prevalence of psychological distress, which in itself results into an impaired quality of life (QoL). Vitamin D could ameliorate the symptoms of patients suffering from IBS through its beneficial effects on psychological factors and inflammation. A total of 90 IBS patients participated in this double-blind, randomized, placebo-controlled study. Participants were randomly selected to receive either 50 000 IU vitamin D3 or a placebo fortnightly for a period of 6 months. Patients reported their IBS symptoms at the baseline and monthly during intervention periods. The IBS severity score system (IBSSS) and IBS-specific QoL questionnaires were used at the baseline and postintervention. Over the 6-month intervention period, a significantly greater improvement in IBS symptoms such as abdominal pain and distention, flatulence, rumbling, and overall gastrointestinal (GI) symptoms (except dissatisfaction with bowel habits) was observed in the patients receiving vitamin D as compared to the placebo group. The IBSSS and the IBS-QoL scores in the vitamin D group significantly improved compared to the placebo group postintervention (mean IBSSS score change: -53.82 ± 23.3 vs -16.85 ± 25.01, p < 0.001, respectively; mean IBS-QoL score change: 14.26 ± 3 vs 11 ± 2.34, p < 0.001, respectively). Vitamin D seems to be an effective and safe option to improve QoL and symptoms of IBS. ClinicalTrials.gov (NCT02579902). © 2016 John Wiley & Sons Ltd.

Treatment of erectile dysfunction with sildenafil citrate in renal allograft recipients: a randomized, double-blind, placebo-controlled, crossover trial.

PubMed

Sharma, Raj K; Prasad, Narayan; Gupta, Amit; Kapoor, Rakesh

2006-07-01

Erectile dysfunction (ED) is observed frequently in patients with end-stage renal disease, hemodialysis patients, and renal allograft recipients. There are few studies of sildenafil use in renal allograft recipients. The study is designed as a randomized, double-blind, placebo-controlled, crossover trial. Efficacy was assessed by using the self-administered International Index of Erectile Function (IIEF), a 15-question validated measure of ED, and a global efficacy question (Did the treatment improve your erection?). Thirty-two eligible renal transplant recipients were included in this study. After treatment with sildenafil citrate, patients had significantly better scores in 13 of 15 questions, except for questions 11 (desire frequency; P = 0.39) and 12 (desire level; P = 0.61). Treatment efficacy assessed through questions 3 (penetration ability; P < 0.001) and 4 (maintenance frequency; P < 0.001) was significantly better after sildenafil therapy. There were no significant differences between baseline and post-placebo treatment scores, except for question 13 (relationship satisfaction). Patients treated with sildenafil had significantly better scores in 4 domains compared with baseline, but a difference was not observed in the sexual desire domain (P = 0.32). There were no significant differences in scores between placebo and baseline in any domain. On the global efficacy question, 81.3% of patients showed improvement compared with 18.7% with placebo. There were no differences in areas under the curve and maximum cyclosporine concentrations before and after sildenafil therapy. No patient discontinued the drug because of side effects except for 1 patient with visual hallucination. Treatment with sildenafil in renal transplant recipients is a valid option with an effective response.

Randomised controlled trial of butterbur and cetirizine for treating seasonal allergic rhinitis

PubMed Central

Schapowal, Andreas

2002-01-01

Objectives To compare the efficacy and tolerability of butterbur (Petasites hybridus) with cetirizine in patients with seasonal allergic rhinitis (hay fever). Design Randomised, double blind, parallel group comparison. Setting Four outpatient general medicine and allergy clinics in Switzerland and Germany. Participants 131 patients were screened for seasonal allergic rhinitis and 125 patients were randomised (butterbur 61; cetirizine 64). Interventions Butterbur (carbon dioxide extract tablets, ZE 339) one tablet, four times daily, or cetirizine, one tablet in the evening, both given for two consecutive weeks. Main outcome measures Scores on SF-36 questionnaire and clinical global impression scale. Results Improvement in SF-36 score was similar in the two treatment groups for all items tested hierarchically. Butterbur and cetirizine were also similarly effective with regard to global improvement scores on the clinical global impression scale (median score 3 in both groups). Both treatments were well tolerated. In the cetirizine group, two thirds (8/12) of reported adverse events were associated with sedative effects (drowsiness and fatigue) despite the drug being considered a non-sedating antihistamine. Conclusions The effects of butterbur are similar to those of cetirizine in patients with seasonal allergic rhinitis when evaluated blindly by patients and doctors. Butterbur should be considered for treating seasonal allergic rhinitis when the sedative effects of antihistamines need to be avoided. What is already known on this topicSeasonal allergic rhinitis (hay fever) is common in countries with temperate climates.Most patients have their symptoms treated for short periods, particularly during peaks in atmospheric pollen countWhat this study addsAfter two weeks, the effects of butterbur and cetirizine were comparable in patients with hay feverButterbur produced fewer sedating effects than cetirizineButterbur should be considered when the sedating effects of antihistamines must be avoided PMID:11799030

Gait Parameters and Functional Outcomes After Total Knee Arthroplasty Using Persona Knee System With Cruciate Retaining and Ultracongruent Knee Inserts.

PubMed

Rajgopal, Ashok; Aggarwal, Kalpana; Khurana, Anshika; Rao, Arun; Vasdev, Attique; Pandit, Hemant

2017-01-01

Total knee arthroplasty is a well-established treatment for managing end-stage symptomatic knee osteoarthritis. Currently, different designs of prostheses are available with majority ensuring similar clinical outcomes. Altered surface geometry is introduced to strive toward gaining superior outcomes. We aimed to investigate any differences in functional outcomes between 2 different polyethylene designs namely the Persona CR (cruciate retaining) and Persona UC (ultracongruent) tibial inserts (Zimmer-Biomet, Warsaw, IN). This prospective single blind, single-surgeon randomized controlled trial reports on 105 patients, (66 female and 39 male), who underwent simultaneous bilateral total knee arthroplasty using the Persona knee system (Zimmer-Biomet) UC inserts in one side and CR inserts in the contralateral side. By a blind assessor, at regular time intervals patients were assessed in terms of function and gait. The functional knee scoring scales used were the Western Ontario and McMaster Universities Osteoarthritis Index and Modified Knee Society Score. The gait parameters evaluated were foot pressure and step length. During the study period, no patient was lost to follow-up or underwent revision surgery for any cause. Western Ontario and McMaster Universities Osteoarthritis Index scores, Modified Knee Society Score, and knee range of motion of all 105 patients assessed preoperatively and postoperatively at 6 months, 1 year, and 2 years showed statistically better results (P < .05) for UC inserts. Gait analysis measuring foot pressures and step length, however, did not show any statistically significant differences at 2-year follow-up. Ultracongruent tibial inserts show significantly better functional outcomes as compared to CR inserts during a 2-year follow-up period. However, in this study these findings were not shown to be attributed to differences in gait parameters. Copyright © 2016 Elsevier Inc. All rights reserved.

Sleeping in moderate hypoxia at home for prevention of acute mountain sickness (AMS): a placebo-controlled, randomized double-blind study.

PubMed

Dehnert, Christoph; Böhm, Astrid; Grigoriev, Igor; Menold, Elmar; Bärtsch, Peter

2014-09-01

Acclimatization at natural altitude effectively prevents acute mountain sickness (AMS). It is, however, unknown whether prevention of AMS is also possible by only sleeping in normobaric hypoxia. In a placebo-controlled, double-blind study 76 healthy unacclimatized male subjects, aged 18 to 50 years, slept for 14 consecutive nights at either a fractional inspired oxygen (Fio2) of 0.14 to 0.15 (average target altitude 3043 m; treatment group) or 0.209 (control group). Four days later, AMS scores and incidence of AMS were assessed during a 20-hour exposure in normobaric hypoxia at Fio2 = 0.12 (equivalent to 4500 m). Because of technical problems with the nitrogen generators, target altitude was not achieved in the tents and only 21 of 37 subjects slept at an average altitude considered sufficient for acclimatization (>2200 m; average, 2600 m). Therefore, in a subgroup analysis these subjects were compared with the 21 subjects of the control group with the lowest sleeping altitude. This analysis showed a significantly lower AMS-C score (0.38; 95% CI, 0.21 to 0.54) vs 1.10; 95% CI, 0.57 to 1.62; P = .04) and lower Lake Louise Score (3.1; 95% CI, 2.2 to 4.1 vs 5.1; 95% CI, 3.6 to 6.6; P = .07) for the treatment subgroup. The incidence of AMS defined as an AMS-C score greater than 0.70 was also significantly lower (14% vs 52%; P < .01). Sleeping 14 consecutive nights in normobaric hypoxia (equivalent to 2600 m) reduced symptoms and incidence of AMS 4 days later on exposure to 4500 m. Copyright © 2014 Wilderness Medical Society. Published by Elsevier Inc. All rights reserved.

Droxidopa in patients with neurogenic orthostatic hypotension associated with Parkinson's disease (NOH306A).

PubMed

Hauser, Robert A; Hewitt, L Arthur; Isaacson, Stuart

2014-01-01

Neurogenic orthostatic hypotension (nOH) is common in Parkinson's disease (PD), and represents a failure to generate norepinephrine responses appropriate for postural change. Droxidopa (L-threo-3,4-dihydroxyphenylserine) is an oral norepinephrine prodrug. Interim analyses of the initial patients enrolled in a multicenter, randomized, double-blind, placebo-controlled phase 3 trial of droxidopa for nOH in PD (ClinicalTrials.gov Identifier: NCT01176240). PD patients with documented nOH underwent ≤ 2 weeks of double-blind droxidopa or placebo dosage optimization followed by 8 weeks of maintenance treatment (100-600 mg t.i.d.). The primary efficacy measure was change in Orthostatic Hypotension Questionnaire (OHQ) composite score from baseline to Week 8. Key secondary variables included dizziness/lightheadedness score (OHQ item 1) and patient-reported falls. Among 24 droxidopa and 27 placebo recipients, mean OHQ composite-score change at Week 8 was -2.2 versus -2.1 (p = 0.98); in response to this pre-planned futility analysis, the study was temporarily stopped and all data from these patients were considered exploratory. At Week 1, mean dizziness/lightheadedness score change favored droxidopa by 1.5 units (p = 0.24), with subsequent numerical differences favoring droxidopa throughout the observation period, and at Week 1, mean standing systolic blood-pressure change favored droxidopa by 12.5 mmHg (p = 0.04). Compared with placebo, the droxidopa group exhibited an approximately 50% lower rate of reported falls (p = 0.16) and fall-related injuries (post-hoc analysis). This exploratory analysis of a small dataset failed to show benefit of droxidopa, as compared with placebo by the primary endpoint. Nonetheless, there were signals of potential benefit for nOH, including improvement in dizziness/lightheadedness and reduction in falls, meriting evaluation in further trials.

Cognitive training for technical and non-technical skills in robotic surgery: a randomised controlled trial.

PubMed

Raison, Nicholas; Ahmed, Kamran; Abe, Takashige; Brunckhorst, Oliver; Novara, Giacomo; Buffi, Nicolò; McIlhenny, Craig; van der Poel, Henk; van Hemelrijck, Mieke; Gavazzi, Andrea; Dasgupta, Prokar

2018-05-07

To investigate the effectiveness of motor imagery (MI) for technical skill and non-technical skill (NTS) training in minimally invasive surgery (MIS). A single-blind, parallel-group randomised controlled trial was conducted at the Vattikuti Institute of Robotic Surgery, King's College London. Novice surgeons were recruited by open invitation in 2015. After basic robotic skills training, participants underwent simple randomisation to either MI training or standard training. All participants completed a robotic urethrovesical anastomosis task within a simulated operating room. In addition to the technical task, participants were required to manage three scripted NTS scenarios. Assessment was performed by five blinded expert surgeons and a NTS expert using validated tools for evaluating technical skills [Global Evaluative Assessment of Robotic Skills (GEARS)] and NTS [Non-Technical Skills for Surgeons (NOTSS)]. Quality of MI was assessed using a revised Movement Imagery Questionnaire (MIQ). In all, 33 participants underwent MI training and 29 underwent standard training. Interrater reliability was high, Krippendorff's α = 0.85. After MI training, the mean (sd) GEARS score was significantly higher than after standard training, at 13.1 (3.25) vs 11.4 (2.97) (P = 0.03). There was no difference in mean NOTSS scores, at 25.8 vs 26.4 (P = 0.77). MI training was successful with significantly higher imagery scores than standard training (mean MIQ score 5.1 vs 4.5, P = 0.04). Motor imagery is an effective training tool for improving technical skill in MIS even in novice participants. No beneficial effect for NTS was found. © 2018 The Authors BJU International © 2018 BJU International Published by John Wiley & Sons Ltd.

Effects of sulfur bath on hip osteoarthritis: a randomized, controlled, single-blind, follow-up trial: a pilot study.

PubMed

Kovács, Csaba; Bozsik, Ágnes; Pecze, Mariann; Borbély, Ildikó; Fogarasi, Andrea; Kovács, Lajos; Tefner, Ildikó Katalin; Bender, Tamás

2016-11-01

The effects of balneotherapy were evaluated in patients with osteoarthritis of the hip. This randomized, controlled, investigator-blinded study enrolled outpatients with hip osteoarthritis according to ACR criteria. In addition to home exercise therapy, one patient group received balneotherapy for 3 weeks on 15 occasions. The mineral water used in this study is one of the mineral waters with the highest sulfide ion content (13.2 mg/L) in Hungary. The control group received exercise therapy alone. The WOMAC Likert 3.1 index and the EQ-5D quality of life self-administered questionnaire were completed three times during the study: prior to first treatment, at the end of the 3-week treatment course, and 12 weeks later. The main endpoint was achievement of Minimal Clinically Important Improvement (MCII) at 12 weeks, defined as ≥7.9 points in a normalized WOMAC function score. The intention to treat analysis included 20 controls and 21 balneotherapy patients. At 12 weeks, 17 (81 %) balneotherapy group patients had Minimal Clinically Important Improvement and 6 (30 %) of controls (p = 0.001). Comparing the results of the two groups at the end of treatment, there was a significant difference in the WOMAC stiffness score only, whereas after 12 weeks, the WOMAC pain, stiffness, function, and total scores also showed a significant difference in favor of the balneotherapy group. The difference between the two groups was significant after 12 weeks in point of EQVAS score, too. The results of our study suggest that the combination of balneotherapy and exercise therapy achieves more sustained improvement of joint function and decreases in pain than exercise therapy alone.

Total hip arthroplasty and perioperative oral carbohydrate treatment: a randomised, double-blind, controlled trial.

PubMed

Harsten, Andreas; Hjartarson, Hjörtur; Toksvig-Larsen, Sören

2012-06-01

Perioperative oral carbohydrate intake is beneficial to general surgery patients. Total hip arthroplasty is a common surgical procedure, and even a moderate improvement in patient outcome could have a significant effect on the resources needed for these patients. However, few studies have focused on the effects of carbohydrate intake on orthopaedic patients. The purpose of this study was to investigate if perioperative oral carbohydrate intake alters the postoperative course for patients undergoing total hip arthroplasty. The primary hypothesis was that pain scores would be lower in patients treated with carbohydrate. A randomised, double-blind, controlled trial. This study was carried out between September 2009 and April 2011 at a district Swedish hospital that specialises in orthopaedic surgery. Sixty ASA physical status I-III patients scheduled for elective total hip arthroplasty were included. Exclusion criteria were obesity, diabetes, prior hip surgery to the same hip, ongoing infection, immunological deficiency or age less than 50 or more than 80 years. Patients were given 400 ml of either an oral 12.5% carbohydrate solution or a placebo beverage (flavoured water) 1.5 h before and 2 h after surgery. Visual analogue scales were used to score six discomfort parameters. Immediately prior to surgery, the carbohydrate-treated patients were less hungry (median score 9.5 vs. 22 mm) and experienced less nausea (0 vs. 1.5 mm) (P< 0.05). Postoperatively, patients in the carbohydrate group experienced less pain at 12, 16 and 20 h (median scores 20, 30 and 34 vs. 7, 5 and 0 mm; P<0.05). This study shows that there is limited benefit from administering oral carbohydrate prior to total hip arthroplasty.

Reduced health-related quality of life among Japanese college students with visual impairment.

PubMed

Masaki, Iguchi

2015-01-01

Although previous studies have shown detrimental effects of visual impairment on health-related quality of life (HRQOL), they were primarily conducted on elderly individuals with visual impairment. The objective of this cross-sectional study was to investigate if HRQOL is impaired in young college students with visual impairment and to explore the relationships between HRQOL and other factors. It was hypothesized that visual impairment is not influential enough to lower the HRQOL of young people due to their better physical fitness and more flexible mentality. A total of 21 college students (mean age = 25 years old) with varying degrees of visual impairment completed the short form (SF)-36 health survey and questionnaires on daily physical activities. Subjects were grouped depending on the type of visual impairment: blind (n = 11) or severely impaired (n = 10). In addition, grip strength and single-leg standing balance were assessed. No between-group differences were found in the SF-36 scores. However, compared to the general Japanese standards (50.0 ± 10.0), the Vitality scores of the blind group were lower (41.9 ± 7.2, p = 0.004) and the Physical Function scores of the severely impaired group were higher (55.3 ± 2.4, p = 0.001). In addition, a negative correlation was found between standing balance (variability of foot center of pressure) and the Physical Component Summary score of the SF-36 (r(2) = 0.35, p = 0.005). These findings suggest that even among young people severe visual impairment leads to reductions in some components of HRQOL.

Sono-electro-magnetic therapy for treating chronic pelvic pain syndrome in men: a randomized, placebo-controlled, double-blind trial.

PubMed

Kessler, Thomas M; Mordasini, Livio; Weisstanner, Christian; Jüni, Peter; da Costa, Bruno R; Wiest, Roland; Thalmann, George N

2014-01-01

To assess the efficacy and safety of sono-electro-magnetic therapy compared to placebo in men with refractory CPPS. In a randomized, placebo-controlled, double-blind single center trial, we assessed the effect of sono-electro-magnetic therapy in men with treatment refractory CPPS. Sixty male patients were randomly assigned to treatment with either sono-electro-magnetic (n = 30) or placebo therapy (n = 30) for 12 weeks. The primary outcome was a change in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) from baseline to 12 weeks. The 12-week difference between sono-electro-magnetic and placebo therapy in changes of the NIH-CPSI total score was -3.1 points (95% CI -6.8 to 0.6, p = 0.11). In secondary comparisons of NIH-CPSI sub-scores, we found differences between groups most pronounced for the quality-of-life sub-score (difference at 12 weeks -1.6, 95% CI -2.8 to -0.4, p = 0.015). In stratified analyses, the benefit of sono-electro-magnetic therapy appeared more pronounced among patients who had a symptom duration of 12 months or less (difference in NIH-CPSI total score -8.3, 95% CI -14.5 to 2.6) than in patients with a longer symptom duration (-0.8, 95% CI -4.6 to 3.1; p for interaction = 0.023). Sono-electro-magnetic therapy did not result in a significant improvement of symptoms in the overall cohort of treatment refractory CPPS patients compared to placebo treatment. Subgroup analysis indicates, however, that patients with a symptom-duration of 12 months or less may benefit from sono-electro-magnetic therapy, warranting larger randomized controlled trials in this subpopulation. ClinicalTrials.gov NCT00688506.

Effect of Royal Jelly on premenstrual syndrome among Iranian medical sciences students: a randomized, triple-blind, placebo-controlled study.

PubMed

Taavoni, Simin; Barkhordari, Fatemeh; Goushegir, Ashrafeddin; Haghani, Hamid

2014-08-01

Premenstrual syndrome (PMS) may have negative effects on women's health and sometimes need therapeutic non-pharmacological management. To determine the effect of oral consumption of 1000 mg Royal Jelly capsule on premenstrual syndrome. This is a randomized, triple-blind, placebo-controlled clinical trial, which was conducted in Tehran University of Medical Sciences female dormitories between December 2011 and October 2012. The study population comprised 110 medical sciences student with PMS, whom were randomly assigned to an intervention or a control group. Each participant in the intervention group took one Royal jelly capsule orally per day, starting on the first day of menstruation and continued the same treatment daily throughout two consecutive menstrual cycles, while participants in the intervention group took placebo capsules as same method. The outcome measure in this study was PMS score as obtained through the Premenstrual Profile 2005. The mean of personal characteristics and baseline level of the premenstrual score before intervention did not differ between groups. After two consecutive months consumption of Royal Jelly, PMS score had decreased from 23.17 ± 17.43 to 11.42 ± 14.58 (mean change: 11.75; 95% confidence interval [CI]: 8.31-15.19) and in Placebo, PMS score changed from 21.48 ± 16.39 to 20.27 ± 15.76 (mean change: 1.20; 95% CI: -1.69 to 4.10). Also difference between mean changes was significant (mean difference: 10.54; 95% CI: 6.10-14.98). The results of the study have demonstrated that 2 months consumption of Royal Jelly was effective in reducing PMS. Copyright © 2014. Published by Elsevier Ltd.

Randomized, Double-Blind, Placebo-Controlled Trial of N-Acetylcysteine Augmentation for Treatment-Resistant Obsessive-Compulsive Disorder.

PubMed

Costa, Daniel L C; Diniz, Juliana B; Requena, Guaraci; Joaquim, Marinês A; Pittenger, Christopher; Bloch, Michael H; Miguel, Euripedes C; Shavitt, Roseli G

2017-07-01

To evaluate the efficacy of serotonin reuptake inhibitor (SRI) augmentation with N-acetylcysteine (NAC), a glutamate modulator and antioxidant medication, for treatment-resistant obsessive-compulsive disorder (OCD). We conducted a randomized, double-blind, placebo-controlled, 16-week trial of NAC (3,000 mg daily) in adults (aged 18-65 years) with treatment-resistant OCD, established according to DSM-IV criteria. Forty subjects were recruited at an OCD-specialized outpatient clinic at a tertiary hospital (May 2012-October 2014). The primary outcome measure was the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) scores. To evaluate the variables group, time, and interaction effects for Y-BOCS scores at all time points, we used nonparametric analysis of variance with repeated measures. Secondary outcomes were the severity scores for anxiety, depression, specific OCD symptom dimensions, and insight. Both groups showed a significant reduction of baseline Y-BOCS scores at week 16: the NAC group had a reduction of 4.3 points (25.6 to 21.3), compared with 3.0 points (24.8 to 21.8) for the placebo group. However, there were no significant differences between groups (P = .92). Adding NAC was superior to placebo in reducing anxiety symptoms (P = .02), but not depression severity or specific OCD symptom dimensions. In general, NAC was well tolerated, despite abdominal pain being more frequently reported in the NAC group (n [%]: NAC = 9 [60.0], placebo = 2 [13.3]; P < .01). Our trial did not demonstrate a significant benefit of NAC in reducing OCD severity in treatment-resistant OCD adults. Secondary analysis suggested that NAC might have some benefit in reducing anxiety symptoms in treatment-resistant OCD patients. ClinicalTrials.gov identifier: NCT01555970. © Copyright 2017 Physicians Postgraduate Press, Inc.

Effects of sulfur bath on hip osteoarthritis: a randomized, controlled, single-blind, follow-up trial: a pilot study

NASA Astrophysics Data System (ADS)

Kovács, Csaba; Bozsik, Ágnes; Pecze, Mariann; Borbély, Ildikó; Fogarasi, Andrea; Kovács, Lajos; Tefner, Ildikó Katalin; Bender, Tamás

2016-11-01

The effects of balneotherapy were evaluated in patients with osteoarthritis of the hip. This randomized, controlled, investigator-blinded study enrolled outpatients with hip osteoarthritis according to ACR criteria. In addition to home exercise therapy, one patient group received balneotherapy for 3 weeks on 15 occasions. The mineral water used in this study is one of the mineral waters with the highest sulfide ion content (13.2 mg/L) in Hungary. The control group received exercise therapy alone. The WOMAC Likert 3.1 index and the EQ-5D quality of life self-administered questionnaire were completed three times during the study: prior to first treatment, at the end of the 3-week treatment course, and 12 weeks later. The main endpoint was achievement of Minimal Clinically Important Improvement (MCII) at 12 weeks, defined as ≥7.9 points in a normalized WOMAC function score. The intention to treat analysis included 20 controls and 21 balneotherapy patients. At 12 weeks, 17 (81 %) balneotherapy group patients had Minimal Clinically Important Improvement and 6 (30 %) of controls ( p = 0.001). Comparing the results of the two groups at the end of treatment, there was a significant difference in the WOMAC stiffness score only, whereas after 12 weeks, the WOMAC pain, stiffness, function, and total scores also showed a significant difference in favor of the balneotherapy group. The difference between the two groups was significant after 12 weeks in point of EQVAS score, too. The results of our study suggest that the combination of balneotherapy and exercise therapy achieves more sustained improvement of joint function and decreases in pain than exercise therapy alone.

Does consumption of polyunsaturated fatty acids influence on neurorehabilitation in traumatic spinal cord-injured individuals? A double-blinded clinical trial.

PubMed

Norouzi Javidan, A; Sabour, H; Latifi, S; Abrishamkar, M; Soltani, Z; Shidfar, F; Emami Razavi, H

2014-05-01

A double-blinded randomized clinical trial. The anti-inflammatory and neuroprotective effect of omega-3 fatty acids have been shown so far, but still its influence on clinical measures in spinal cord-injured human models were not known. We tried to investigate changes in disability and dependency scores in chronic traumatic spinal cord-injured patients after 14 months of ω-3 fatty-acid consumption. Main inclusion criteria were: traumatic spinal cord injury (SCI) and post injury duration longer than 1 year. Disability and dependency was assessed using U.K Functional Independence Measure and Functional Assessment Measure (FIM+FAM) scale. MorDHA capsules (435 mg of docosahexaenoic acid and 65 mg of eicosapentaenoic acid) were administered in treatment group, whereas control group received placebo capsules for 14 months. U.K. FIM+FAM scale were estimated before intervention and at the end of the trial. Fifty-four patients in treatment group and 50 patients in placebo group completed the trial. Highest scores were detected in cognitive domain in both groups before and after intervention. Most dependency was observed in locomotion subscale and secondly in sphincter control. Scores of none of these components were changed by ω-3 fatty-acid consumption. Although omega-3 fatty acids have been shown to have neuroprotective effect in acute phase of SCI, it seems that they have no significant influence in chronic inflammatory state of SCI. The positive effect of ω-3 fatty acid in chronic neurorecovery process, if exists, is weaker to exert any significant improvement in UK FIM+FAM scores in spinal cord-injured individuals.

Randomized, single-blind, controlled trial of a specialist behavior therapy team for challenging behavior in adults with intellectual disabilities.

PubMed

Hassiotis, Angela; Robotham, Dan; Canagasabey, Anton; Romeo, Renee; Langridge, Diane; Blizard, Robert; Murad, Shahed; King, Michael

2009-11-01

Community-based specialist behavior therapy teams may be helpful in managing challenging behavior, but evidence of their effectiveness is limited. This study was designed to examine the effectiveness and costs associated with treatment by a specialist behavior therapy team. This was a parallel-group, randomized, single-blind controlled trial carried out in an intellectual disabilities service in England. Participants were 63 male and female service users with mild to severe intellectual disability who presented with challenging behavior. The interventions were standard treatment plus applied behavioral analysis (N=32) and standard treatment only (N=31). The primary outcome measure was challenging behavior, as measured by total and subscale scores on the Aberrant Behavior Checklist 3 and 6 months after randomization. Secondary outcome measures were psychiatric comorbidity assessed at 3 and 6 months using the Psychiatric Assessment Schedule for Adults With a Developmental Disability Checklist (PAS-ADD) and total costs recorded at 6 months. Multilevel modeling was used to compare square root transformations of Aberrant Behavior Checklist scores. Significant differences were found in the transformed total scores on the Aberrant Behavior Checklist (difference=-0.89, 95% CI=-1.74 to -0.04) and transformed lethargy and hyperactivity subscale scores (common intervention effect=-0.56, 95% CI=-0.97 to -0.15). Standard care participants fared worse on the PAS-ADD comorbid organic disorder subscale. There was a clear trend for lower overall costs of the intervention. Use of a specialist behavior therapy team in addition to standard treatment appears to be more effective in improving challenging behavior and may have financial advantages over standard treatment.

Transversus Abdominis Plane Block Versus Surgical Site Infiltration for Pain Management After Open Total Abdominal Hysterectomy.

PubMed

Gasanova, Irina; Alexander, John; Ogunnaike, Babatunde; Hamid, Cherine; Rogers, David; Minhajuddin, Abu; Joshi, Girish P

2015-11-01

Surgical site infiltration and transversus abdominis plane (TAP) blocks are commonly used to improve pain relief after lower abdominal surgery. This randomized, observer-blinded study was designed to compare the analgesic efficacy of TAP blocks with surgical site infiltration in patients undergoing open total abdominal hysterectomy via a Pfannenstiel incision. Patients were randomized to receive either bilateral ultrasound-guided TAP blocks using bupivacaine 0.5% 20 mL on each side (n = 30) or surgical site infiltration with liposomal bupivacaine 266 mg diluted to 60 mL injected in the preperitoneal, subfascial, and subcutaneous planes (n = 30). The remaining aspects of the perioperative care were standardized. An investigator blinded to the group allocation documented pain scores at rest and with coughing, opioid requirements, nausea, vomiting, and rescue antiemetics in the postanesthesia care unit and at 2, 6, 12, 24, and 48 hours postoperatively. The primary outcome measure was pain scores on coughing at 6 hours postoperatively. One patient in each group was excluded from the analysis because of reoperation within 24 hours in the TAP block group and change of incision type in the infiltration group. The pain scores at rest and with coughing were significantly lower in the surgical site infiltration group at all postoperative time points (P < 0.0001) except at rest in the postanesthesia care unit. The opioid requirements between 24 and 48 hours were significantly lower in the infiltration group (P = 0.009). The nausea scores, occurrence of vomiting, and need for rescue antiemetics were similar. Surgical site infiltration provided superior pain relief at rest and on coughing, as well as reduced opioid consumption for up to 48 hours. Future studies need to compare TAP blocks with liposomal bupivacaine with surgical site infiltration with liposomal bupivacaine.

White spot lesion remineralization by sugar-free chewing gum containing bio-available calcium and fluoride: A double-blind randomized controlled trial.

PubMed

Sugiura, Miho; Kitasako, Yuichi; Sadr, Alireza; Shimada, Yasushi; Sumi, Yasunori; Tagami, Junji

2016-11-01

To assess the effect of chewing gum containing phosphoryl oligosaccharides of calcium (POs-Ca) and fluoride on white spot lesion (WSL) remineralization in comparison with POs-Ca or placebo (control) chewing gums, in double- blind, randomized, controlled trial. Thirty-seven healthy subjects, who had at least one WSL, with an ICDAS score of 2 or 1, were recruited for this study. The subjects were randomly divided into three groups (control, POs-Ca, POs-Ca+F) and chewed two slabs of each gum three times every day for 3 months. WSLs were assessed using ICDAS criteria and optical boundary depth (BD) by optical coherence tomography (OCT) system at a monthly recall. Data were analyzed by Wilcoxon rank-sum test and Wilcoxon signed rank test with Bonferroni corrections at 0.05 significance level. Visual score changes from ICDAS score 2 to score 1 over the course of the study were observed; control (30%), POs-Ca (48%) and POs-Ca+F (45%). Unlike the control gum, chewing POs-Ca and POs-Ca+F gums resulted in significant changes in the mean value of BD over the 3 months course of the study (p<0.05). There was a significant difference in mean value of BD after first month between POs-Ca+F and control groups (p<0.05). This study highlighted the importance of calcium and fluoride ion bioavailability in the reinforcement of demineralized enamel lesions by chewing gums. Furthermore, adding fluoride to POs-Ca might speed up the remineralization progress on natural WSL. Copyright © 2016 Elsevier Ltd. All rights reserved.

Ziprasidone Augmentation of Escitalopram for Major Depressive Disorder: Efficacy Results From a Randomized, Double-Blind, Placebo-Controlled Study.

PubMed

Papakostas, George I; Fava, Maurizio; Baer, Lee; Swee, Michaela B; Jaeger, Adrienne; Bobo, William V; Shelton, Richard C

2015-12-01

The authors sought to test the efficacy of adjunctive ziprasidone in adults with nonpsychotic unipolar major depression experiencing persistent symptoms after 8 weeks of open-label treatment with escitalopram. This was an 8-week, randomized, double-blind, parallel-group, placebo-controlled trial conducted at three academic medical centers. Participants were 139 outpatients with persistent symptoms of major depression after an 8-week open-label trial of escitalopram (phase 1), randomly assigned in a 1:1 ratio to receive adjunctive ziprasidone (escitalopram plus ziprasidone, N=71) or adjunctive placebo (escitalopram plus placebo, N=68), with 8 weekly follow-up assessments. The primary outcome measure was clinical response, defined as a reduction of at least 50% in score on the 17-item Hamilton Depression Rating Scale (HAM-D). The Hamilton Anxiety Rating scale (HAM-A) and Visual Analog Scale for Pain were defined a priori as key secondary outcome measures. Rates of clinical response (35.2% compared with 20.5%) and mean improvement in HAM-D total scores (-6.4 [SD=6.4] compared with -3.3 [SD=6.2]) were significantly greater for the escitalopram plus ziprasidone group. Several secondary measures of antidepressant efficacy also favored adjunctive ziprasidone. The escitalopram plus ziprasidone group also showed significantly greater improvement on HAM-A score but not on Visual Analog Scale for Pain score. Ten (14%) patients in the escitalopram plus ziprasidone group discontinued treatment because of intolerance, compared with none in the escitalopram plus placebo group. Ziprasidone as an adjunct to escitalopram demonstrated antidepressant efficacy in adult patients with major depressive disorder experiencing persistent symptoms after 8 weeks of open-label treatment with escitalopram.

Early effect on general interest, and short-term antidepressant efficacy and safety of agomelatine (25-50mg/day) and escitalopram (10-20mg/day) in outpatients with Major Depressive Disorder. A 12-week randomised double-blind comparative study.

PubMed

Udristoiu, T; Dehelean, P; Nuss, Ph; Raba, V; Picarel-Blanchot, F; de Bodinat, C

2016-07-15

A double-blind, randomized, study was conducted in 29 centers in Romania to evaluate the effect of agomelatine 25-50mg/day (n=144 patients) on general interest, overall clinical efficacy, and functionality in comparison with escitalopram 10-20mg/day (n=143 patients) in out-patients diagnosed with moderate to severe Major Depressive Disorder (MDD). The primary endpoint of the study was the score difference between agomelatine and escitalopram were assessed on the item 13 of the Quick Inventory of Depressive Symptomatology (16-Item) Self-Report (QIDS-SR16) over the first week period. Secondary measures include the primary criterion on the 12-week period, the within-group evolution over 12 weeks of the 17-item Hamilton Depression Scale (HAM-D17) total score, CGI severity of illness (CGI-S) and CGI-I scores, and functionality by using the self-rated Sheehan Disability Scale (SDS). After one week, the mean General Interest score showed no statistically significant difference between treatments. Over 12 weeks, patients felt more and more interested in other people and activities than before having taken medication. Both agomelatine and escitalopram improved depressive symptoms and symptom-related functional impairment of patients. Both agomelatine and escitalopram were well-tolerated by patients. The strength of our results would benefit from additional data from trials using a similar design and other active comparators. There was no difference in week 1 changes of interest between agomelatine and escitalopram. The relatively good tolerability of agomelatine and escitalopram is confirmed. Copyright © 2016 Elsevier B.V. All rights reserved.

Individualised Expert Feedback is Not Essential for Improving Basic Clinical Skills Performance in Novice Learners: A Randomized Trial.

PubMed

Phillips, Alexander W; Matthan, Joanna; Bookless, Lucy R; Whitehead, Ian J; Madhavan, Anantha; Rodham, Paul; Porter, Anna L R; Nesbitt, Craig I; Stansby, Gerard

To determine whether unsupervised video feedback (UVF) is as effective as direct expert feedback (DEF) in improving clinical skills performance for medical students learning basic surgical skills-intravenous cannulation, catheterization, and suturing. Feedback is a vital component of the learning process, yet great variation persists in its quality, quantity, and methods of delivery. The use of video technology to assist in the provision of feedback has been adopted increasingly. A prospective, blinded randomized trial comparing DEF, an expert reviewing students' performances with subsequent improvement suggestions, and UVF, students reviewing their own performance with an expert teaching video, was carried out. Medical students received an initial teaching lecture on intravenous cannulation, catheterization, and suturing and were then recorded performing the task. They subsequently received either DEF or UVF before reperforming the task. Students' recordings were additionally scored by 2 blinded experts using a validated proforma. A total of 71 medical students were recruited. Cannulation scores improved 4.3% with DEF and 9.5% with UVF (p = 0.044), catheterization scores improved 8.7% with DEF and 8.9% with UVF (p = 0.96), and suturing improved 15.6% with DEF and 13.2% with UVF (p = 0.54). Improvement from baseline scores was significant in all cases (p < 0.05). Video-assisted feedback allows a significant improvement in clinical skills for novices. No significant additional benefit was demonstrated from DEF, and a similar improvement can be obtained using a generic expert video and allowing students to review their own performance. This could have significant implications for the design and delivery of such training. Copyright © 2017 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

A randomized, single-blind cross-over design evaluating the effectiveness of an individually defined, targeted physical therapy approach in treatment of children with cerebral palsy.

PubMed

Franki, Inge; Van den Broeck, Christine; De Cat, Josse; Tijhuis, Wieke; Molenaers, Guy; Vanderstraeten, Guy; Desloovere, Kaat

2014-10-01

A pilot study to compare the effectiveness of an individual therapy program with the effects of a general physical therapy program. A randomized, single-blind cross-over design. Ten ambulant children with bilateral spastic cerebral palsy, age four to nine years. Participants were randomly assigned into a ten-week individually defined, targeted or a general program, followed by a cross-over. Evaluation was performed using the Gross Motor Function Measure-88 and three-dimensional gait analysis. General outcome parameters were Gross Motor Function Measure-88 scores, time and distance parameters, gait profile score and movement analysis profiles. Individual goal achievement was evaluated using z-scores for gait parameters and Goal Attainment Scale for gross motor function. No significant changes were observed regarding gross motor function. Only after individualized therapy, step- and stride-length increased significantly (p = 0.022; p = 0.017). Change in step-length was higher after the individualized program (p = 0.045). Within-group effects were found for the pelvis in transversal plane after the individualized program (p = 0.047) and in coronal plane after the general program (p = 0.047). Between-program differences were found for changes in the knee in sagittal plane, in the advantage of the individual program (p = 0.047). A median difference in z-score of 0.279 and 0.419 was measured after the general and individualized program, respectively. Functional goal attainment was higher after the individual therapy program compared with the general program (48 to 43.5). The results indicate slightly favorable effects towards the individualized program. To detect clinically significant changes, future studies require a minimal sample size of 72 to 90 participants. © The Author(s) 2014.

Effect of extracorporeal shock wave therapy on scar pain in burn patients: A prospective, randomized, single-blind, placebo-controlled study.

PubMed

Cho, Yoon Soo; Joo, So Young; Cui, Huisong; Cho, Sung-Rae; Yim, Haejun; Seo, Cheong Hoon

2016-08-01

Extracorporeal shock wave therapy (ESWT) has been used to reduce pain in patients with various musculoskeletal diseases and wounds. We investigated the effect of ESWT on scar pain after complete wound epithelialization in burn patients. A prospective, single-blind, placebo-controlled study was conducted from February 2014 to 2015. Forty patients with burn scar pain despite standard therapy (medication, physical therapy, and burn rehabilitation massage therapy) were randomized into ESWT or control (sham ESWT) groups. ESWT was administered at 100 impulses/cm (0.05-0.15 mJ/mm) once per week for 3 weeks. The treatment effects were assessed using the numerical rating scale (NRS), pain threshold, Nirschl pain phase system, and Roles and Maudsley scores. The characteristics of patients between the 2 study groups were balanced (P >0.05) for age, sex, and total burn surface area (%). In both groups, the NRS, pain threshold (Ib/cm), and Nirschl pain phase system values significantly improved (P <0.05) after 3 sessions of ESWT or sham therapy, and there were significant differences between the 2 groups in terms of these 3 variables (P <0.001, P <0.001, P = 0.013, respectively). The Roles and Maudsley scores significantly improved; among 20 patients, 17 reported a score of poor (85%) and 3 reported fair (15%) before ESWT, whereas 3 reported poor (15%), 8 reported fair (40%), 5 reported good (25%), and 4 reported excellent (20%) after ESWT (P = 0.004). The scores did not improve in the control group (P = 0.128). ESWT significantly reduced scar pain in burn patients after wound recovery.

Staphylococcus aureus biofilms: Nemesis of endoscopic sinus surgery.

PubMed

Singhal, Deepti; Foreman, Andrew; Jervis-Bardy, Joshua; Bardy, Josh-Jervis; Wormald, Peter-John

2011-07-01

Chronic rhinosinusitis (CRS) patients with biofilms have persistent postoperative symptoms, ongoing mucosal inflammation, and recurrent infections. Recent evidence suggests that biofilms of differing species confer varying disease profiles in CRS patients. We aimed to prospectively investigate the effects of Staphylococcus aureus, Pseudomonas aeruginosa, Haemophilus influenzae, and fungal biofilms on outcomes following endoscopic sinus surgery (ESS). Prospective blinded study. In this prospective blinded study, 39 patients undergoing ESS for CRS assessed their symptoms preoperatively using internationally accepted standardized symptom scoring systems and quality-of-life measures (10-point visual analog scale, Sino-Nasal Outcome Test-20, global severity of CRS). Their sinonasal mucosa was graded (Lund-Kennedy scale) and extent of radiologic disease on computed tomography scans scored (Lund-McKay scale). Random sinonasal tissue samples were assessed for different bacterial species forming biofilms by using fluorescent in-situ hybridization and confocal laser microscopy. For 12 months after surgery, CRS symptoms, quality of life, and objective evidence of persisting disease were assessed by using the preoperative tools. Different bacterial species combinations were found in 30 of 39 patients; 60% of these 30 biofilms were polymicrobial biofilms and 70% had S aureus biofilms. Preoperative nasendoscopy and radiologic disease severity were significantly worse in patients with multiple biofilms (P = .02 and P = .01, respectively), and they had worse postsurgery mucosal outcomes on endoscopy (P = .01) requiring significantly more postoperative visits (P = .04). Those with S aureus biofilms progressed poorly with their symptom scores and quality-of-life outcomes, with significant differences in nasendoscopy scores (P = .007). S. aureus biofilms play a dominant role in negatively affecting outcomes of ESS with persisting postoperative symptoms, ongoing mucosal inflammation, and infections. Copyright © 2011 The American Laryngological, Rhinological, and Otological Society, Inc.

Randomized double-blind comparison of cognitive and EEG effects of lacosamide and carbamazepine.

PubMed

Meador, Kimford J; Loring, David W; Boyd, Alan; Echauz, Javier; LaRoche, Suzette; Velez-Ruiz, Naymee; Korb, Pearce; Byrnes, William; Dilley, Deanne; Borghs, Simon; De Backer, Marc; Story, Tyler; Dedeken, Peter; Webster, Elizabeth

2016-09-01

Differential effectiveness of antiepileptic drugs (AEDs) is more commonly determined by tolerability than efficacy. Cognitive effects of AEDs can adversely affect tolerability and quality of life. This study evaluated cognitive and EEG effects of lacosamide (LCM) compared with carbamazepine immediate-release (CBZ-IR). A randomized, double-blind, double-dummy, two-period crossover, fixed-dose study in healthy subjects compared neuropsychological and EEG effects of LCM (150mg, b.i.d.) and CBZ-IR (200mg, t.i.d.). Testing was conducted at screening, predrug baseline, the end of each treatment period (3-week titration; 3-week maintenance), and the end of each washout period (4weeks after treatment). A composite Z-score was derived for the primary outcome variable (computerized cognitive tests and traditional neuropsychological measures) and separately for the EEG measures. Other variables included individual computer, neuropsychological, and EEG scores and adverse events (AEs). Subjects included 60 healthy adults (57% female; mean age: 34.4years [SD: 10.5]); 44 completed both treatments; 41 were per protocol subjects. Carbamazepine immediate-release had worse scores compared with LCM for the primary composite neuropsychological outcome (mean difference=0.33 [SD: 1.36], p=0.011) and for the composite EEG score (mean difference=0.92 [SD: 1.77], p=0.003). Secondary analyses across the individual variables revealed that CBZ-IR was statistically worse than LCM on 36% (4/11) of the neuropsychological tests (computerized and noncomputerized) and 0% of the four EEG measures; none favored CBZ-IR. Drug-related AEs occurred more with CBZ-IR (49%) than LCM (22%). Lacosamide had fewer untoward neuropsychological and EEG effects and fewer AEs and AE-related discontinuations than CBZ-IR in healthy subjects. Lacosamide exhibits a favorable cognitive profile. Copyright © 2016 Elsevier Inc. All rights reserved.

A double-blind, randomized, placebo-controlled trial of fluoxetine in patients with intermittent explosive disorder.

PubMed

Coccaro, Emil F; Lee, Royce J; Kavoussi, Richard J

2009-04-21

Intermittent explosive disorder (IED) is a disorder of impulsive aggression that affects as many as 7.3% of the U.S. population during some period of life. Since central serotonergic (5-HT) system dysfunction is related to impulsive aggressive behavior, pharmacologic enhancement of 5-HT activity should reduce impulsive aggressive behavior in individuals with IED. A double-blind, randomized, placebo-controlled trial of the selective 5-HT uptake inhibitor fluoxetine was conducted in 100 individuals with IED (research diagnostic criteria) and current histories of impulsive aggressive behavior. The primary efficacy measure was the aggression score from the Overt Aggression Scale-Modified (OAS-M) for Outpatient Use. Secondary efficacy measures included the irritability score from the OAS-M and the Clinical Global Impressions-Improvement scale (CGI-I) score. The study took place between July 1990 and July 1999. Fluoxetine treatment resulted in a sustained reduction in OAS-M aggression, and OAS-M irritability scores, apparent as early as week 2 (p < .01 for aggression and p < .001 for irritability at endpoint). Fluoxetine was also superior to placebo in the proportion of responders on the CGI-I (p < .001). Closer examination of the data revealed that full or partial remission of impulsive aggressive behaviors, as reflected by the A criteria for IED, occurred in 46% of fluoxetine-treated subjects. Fluoxetine did not exert an antidepressant or antianxiety effect, and its effects on impulsive aggression were not influenced by presence of current symptoms of depression or anxiety. Fluoxetine treatment has a clear antiaggressive effect in impulsive aggressive individuals with IED. However, while fluoxetine's antiaggressive effects appear robust, they lead to full or partial remission of IED in less than 50% of subjects treated with fluoxetine. Copyright 2009 Physicians Postgraduate Press, Inc.

Topical glyceryl trinitrate treatment of chronic patellar tendinopathy: a randomised, double-blind, placebo-controlled clinical trial.

PubMed

Steunebrink, Mirjam; Zwerver, Johannes; Brandsema, Ruben; Groenenboom, Petra; van den Akker-Scheek, Inge; Weir, Adam

2013-01-01

To assess if continuous topical glyceryl trinitrate (GTN) treatment improves outcome in patients with chronic patellar tendinopathy when compared with eccentric training alone. Randomised double-blind, placebo-controlled clinical trial comparing a 12-week programme of using a GTN or placebo patch in combination with eccentric squats on a decline board. Measurements were performed at baseline, 6, 12 and 24 weeks. Primary outcome measure was the Victorian Institute of Sports Assessment-Patella (VISA-P) questionnaire. Secondary outcome measures were patient satisfaction and pain scores during sports. Generalised estimated equation was used to analyse the treatment, time and treatment×time effect. Analyses were performed following the intention-to-treat principle. VISA-P scores for both groups improved over the study period to 75.0±16.2 and 80.7±22.1 at 24 weeks. Results showed a significant effect for time (p<0.01) but no effect for treatment×time (p=0.80). Mean Visual Analogue Scores pain scores during sports for both groups increased over the study period to 6.6±3 and 7.8±3.1. Results showed a significant effect for time (p<0.01) but no effect for treatment×time (p=0.38). Patient satisfaction showed no difference between GTN and placebo groups (p=0.25) after 24 weeks, but did show a significant difference over time (p=0.01). Three patients in the GTN group reported some rash. It seems that continuous topical GTN treatment in addition to an eccentric exercise programme does not improve clinical outcome compared to placebo patches and an eccentric exercise programme in patients with chronic patellar tendinopathy.

Can repair increase the longevity of composite resins? Results of a 10-year clinical trial.

PubMed

Fernández, E; Martín, J; Vildósola, P; Oliveira Junior, O B; Gordan, V; Mjor, I; Bersezio, C; Estay, J; de Andrade, M F; Moncada, G

2015-02-01

The aim of this double-blind clinical trial was to assess the longevity of repairs to localized clinical defects in composite resin restorations that were initially planned to be treated with a restoration replacement. Twenty-eight patients aged 18-80 years old with 50 composite resin restorations (CR) were recruited. The restorations with localized, marginal, anatomical deficiencies and/or secondary caries adjacent to CR that were "clinically judged" to be suitable for repair or replacement according to the USPHS criteria were randomly assigned to Repair (n=25) or Replacement (n=25) groups, and the quality of the restorations was scored according to the modified USPHS criteria. The restorations were blind and two examiners scored them at baseline (Cohen Kappa agreement score 0.74) and at ten years (Cohen Kappa agreement score 0.87) restorations. Wilcoxon tests were performed for comparisons within the same group (95% CI), and Friedman tests were utilized for multiple comparisons between the different years within each group. Over the decade, the two groups behaved similarly on the parameters of marginal adaptation (MA) (p>0.05), secondary caries (SC) (p>0.05), anatomy (A) (p<0.05), and colour (C) (p>0.05). Given that the MA, SC, A and C parameters behaved similarly in both groups, the repair of composite resins should be elected when clinically indicated, because it is a minimally invasive treatment that can consistently increase the longevity of restorations. The repair of defective composite resins as an alternative treatment to increase their longevity proved to be a safe and effective treatment in the long term. Copyright © 2014 Elsevier Ltd. All rights reserved.

Comparison of cosmetic outcomes of absorbable versus nonabsorbable sutures in pediatric facial lacerations.

PubMed

Luck, Raemma; Tredway, Trevor; Gerard, James; Eyal, Dalit; Krug, Lauren; Flood, Robert

2013-06-01

We sought to compare cosmetic outcomes, complication rates, and patient/caregiver satisfaction of absorbable versus nonabsorbable sutures in children. Healthy patients, 1 to 18 years old, with facial lacerations 1 to 5 cm, were randomized to repair with fast-absorbing catgut (FAC) or nylon (NYL) sutures. Patients returned in 4 to 7 days and in 3 to 4 months, at which time photographs and caregiver surveys were completed. Unlike part I, all FAC sutures were permitted to absorb rather than be removed. Using a 100-mm visual analog scale (VAS), a noninferiority (NI) design was applied, with a difference of less than 15 mm considered clinically equivalent. Caregivers and 3 blinded physicians independently rated the scars via photographs. Ninety-eight patients were enrolled, 76 caregiver surveys were completed, and 61 (29 FAC, 32 NYL) had photographs scored by physicians. The mean physician VAS scores for FAC and NYL were 57.6 and 67.6, respectively (difference, -10.0; 95% confidence interval, -19.1 to -0.4); thus, NI could not be established. The mean caregiver VAS scores for the FAC and NYL groups were 93.8 and 86.6, respectively (difference, 7.2; 95% confidence interval, -4.9 to 13.9); thus, NI of FAC was established. There were no significant differences in rates of infection, wound dehiscence, or keloid formation. In terms of future preference, caregivers favored FAC (33/33) over NYL (26/36) (P < 0.01). Caregiver VAS scores showed NI of FAC, which were also preferred by the caregivers. However, NI for FAC could not be demonstrated by blinded physicians with respect to cosmetic outcomes.

Balneotherapy in fibromyalgia: a single blind randomized controlled clinical study.

PubMed

Ozkurt, Seçil; Dönmez, Arif; Zeki Karagülle, M; Uzunoğlu, Emel; Turan, Mustafa; Erdoğan, Nergis

2012-07-01

We aimed to evaluate the effectiveness of balneotherapy in fibromyalgia management. Fifty women with fibromyalgia under pharmacological treatment were randomly assigned to either the balneotherapy (25) or the control (25) group. Four patients from the balneotherapy group and one patient from the control group left the study after randomization. The patients in the balneotherapy group (21) had 2 thermomineral water baths daily for 2 weeks in Tuzla Spa Center. The patients in the control group (24) continued to have their medical treatment and routine daily life. An investigator who was blinded to the study arms assessed the patients. All patients were assessed four times; at the beginning of the study, at the end of the 2nd week, the 1st month, and the 3rd month after balneotherapy. Outcome measures of the study were pain intensity, Fibromyalgia Impact Questionnaire (FIQ), Beck Depression Inventory (BDI), patient's global assessment, investigator's global assessment, SF-36 scores, and tender point count. Balneotherapy was found to be superior at the end of the cure period in terms of pain intensity, FIQ, Beck Depression Inventory, patient's global assessment, investigator's global assessment scores, and tender point count as compared to the control group. The superiority of balneotherapy lasted up to the end of the 3rd month, except for the Beck Depression Inventory score and the investigator's global assessment score. Significant improvements were observed in PF, GH, and MH subscales of SF-36 during the study period in the balneotherapy group; however, no such improvement was observed in the control group. Balneotherapy was superior only in VT subscale at the end of therapy and at the end of the third month after the therapy as compared to the controls. It was concluded that balneotherapy provides beneficial effects in patients with fibromyalgia.

A double-blind, randomized, placebo-controlled, parallel group study of THC/CBD spray in peripheral neuropathic pain treatment.

PubMed

Serpell, M; Ratcliffe, S; Hovorka, J; Schofield, M; Taylor, L; Lauder, H; Ehler, E

2014-08-01

Peripheral neuropathic pain (PNP) associated with allodynia poses a significant clinical challenge. The efficacy of Δ(9) -tetrahydrocannabinol/cannabidiol (THC/CBD) oromucosal spray, a novel cannabinoid formulation, was investigated in this 15-week randomized, double-blind, placebo-controlled parallel group study. In total, 303 patients with PNP associated with allodynia were screened; 128 were randomized to THC/CBD spray and 118 to placebo, in addition to their current analgesic therapy. The co-primary efficacy endpoints were the 30% responder rate in PNP 0-10 numerical rating scale (NRS) score and the mean change from baseline to the end of treatment in this score. Various key secondary measures of pain and functioning were also investigated. At the 30% responder level, there were statistically significant treatment differences in favour of THC/CBD spray in the full analysis (intention-to-treat) dataset [p = 0.034; 95% confidence interval (CI): 1.05-3.70]. There was also a reduction in mean PNP 0-10 NRS scores in both treatment groups that was numerically higher in the THC/CBD spray group, but which failed to reach statistical significance. Secondary measures of sleep quality 0-10 NRS score (p = 0.0072) and Subject Global Impression of Change (SGIC) (p = 0.023) also demonstrated statistically significant treatment differences in favour of THC/CBD spray treatment. These findings demonstrate that, in a meaningful proportion of otherwise treatment-resistant patients, clinically important improvements in pain, sleep quality and SGIC of the severity of their condition are obtained with THC/CBD spray. THC/CBD spray was well tolerated and no new safety concerns were identified. © 2014 European Pain Federation - EFIC®

Therapeutic effects of short-term monochromatic infrared energy therapy on patients with knee osteoarthritis: a double-blind, randomized, placebo-controlled study.

PubMed

Hsieh, Ru-Lan; Lo, Min-Tzu; Lee, Wen-Chung; Liao, Wei-Cheng

2012-11-01

Randomized, double-blind, placebo-controlled study. To examine the short-term therapeutic effects of monochromatic infrared energy (MIRE) on participants with knee osteoarthritis (OA). Patients were assessed according to the International Classification of Functioning, Disability and Health. MIRE is commonly used in therapy for patients with peripheral neuropathies. However, research has not focused intensively on the therapeutic effects of MIRE in patients with knee OA. This study enrolled 73 participants with knee OA. Participants received six 40-minute sessions of active or placebo MIRE treatment (890-nm wavelength; power, 6.24 W; energy density, 2.08 J/cm2/min; total energy, 83.2 J/cm2) over the knee joints for 2 weeks. International Classification of Functioning, Disability and Health-related outcomes were collected weekly over 4 weeks using the Knee injury and Osteoarthritis Outcome Score, Lysholm Knee Scale, Hospital Anxiety and Depression Scale, Multidimensional Fatigue Inventory, Chronic Pain Grade questionnaire, World Health Organization Quality of Life-brief version, and OA Quality of Life Questionnaire. Data were analyzed by repeated-measures analysis of variance. No statistically significant differences were found for the interaction of group by time for Knee injury and Osteoarthritis Outcome Score scores, including pain, other symptoms, function in daily living, function in sport and recreation, and knee-related quality of life. Scores on the Lysholm Knee Scale, Hospital Anxiety and Depression Scale, Multidimensional Fatigue Inventory, Chronic Pain Grade questionnaire, World Health Organization Quality of Life-brief version, and OA Quality of Life Questionnaire also showed no significant differences between the 2 groups at any of the 4 follow-up assessments. Short-term MIRE therapy provided no beneficial effects to body functions, activities, participation, and quality of life in patients with knee OA.

First collaborative experience with thulium laser ablation of localized upper urinary tract urothelial tumors using retrograde intra-renal surgery.

PubMed

Defidio, Lorenzo; De Dominicis, Mauro; Di Gianfrancesco, Luca; Fuchs, Gerhard; Patel, Anup

2011-09-01

Thulium laser ablation (TLA) outcomes with blinded performance evaluation after retrograde intra-renal surgical (RIRS) treatment of upper urinary tract transitional cell carcinomas (UUT-TCC). A UUT-TCC patient cohort undergoing RIRS-TLA by an international endoscopic surgical collaboration in a European center (April 2005-July 2009), underwent outcomes evaluation. All 4 surgeons were blinded and independently scored both TLA and Holmium:YAG laser ablation performance aspects annually using a Likert scoring system (0-10). All patients (n = 59, median age 66 years, 9 with solitary kidney) had complete UUT inspection. Presenting lesion(s) were intra-renal (n = 30, 51%), ureteral (n = 13, 22%), and combined (n = 16, 27%). Single-stage TLA sufficed in 81.4% (tumors < 1.5 cm). Significant recurrence free survival differences occurred according to primary tumor size >/< 1.5 cm and multi-focality, but location made no difference. Median Likert scores were i) fiber-tip stability --5.5/8.75, p = 0.016; ii) reduced bleeding--5/8.5, p = 0.004; iii)fiber-tip precision--5.5/8.5, p = 0.003; iv) mucosal perforation reduction--3.5/7.5, p = 0.001; v) ablation efficiency tumors < 1.5 cm--6/9, p = 0.017; tumors > 1.5 cm--6.75/6.75, p = 1, and vi) overall efficiency--6/7.5, p = 0.09, for Holmium:YAG and TLA, respectively. The Thulium laser delivered non-inferior recurrence free survival to RIRS-UUT-TCC Holmium:YAG laser ablation, but better median parameter performance scores in fiber-tip stability, precision, reduced bleeding and mucosal perforation reduction in expert ratings. Despite improved photothermal coagulation, and endo-visualization for tumors < 1.5 cm, both ablation and overall efficiency remained challenging for larger tumors with both existing laser technologies.

Withdrawal syndrome after the double-blind cessation of caffeine consumption.

PubMed

Silverman, K; Evans, S M; Strain, E C; Griffiths, R R

1992-10-15

People who stop consuming caffeine may have symptoms, but the incidence and severity of caffeine withdrawal are not known. This study was performed to determine the effects in the general population of ending one's dietary intake of caffeine. We studied 62 normal adults whose intake of caffeine was low to moderate (mean amount, 235 mg--the equivalent of 2.5 cups of coffee--per day). They completed questionnaires about symptoms and tests of their mood and performance when consuming their normal diets (base-line period) and at the end of each of two two-day periods during which they consumed caffeine-free diets and under double-blind conditions received capsules containing placebo (placebo period) or caffeine (caffeine period) in amounts equal to their daily caffeine consumption. More subjects had abnormally high Beck Depression Inventory scores (11 percent), high scores on the trait scale of the State-Trait Anxiety Inventory (8 percent), low vigor scores (11 percent) and high fatigue scores (8 percent) on the Profile of Mood States, and moderate or severe headache (52 percent) during the placebo period than during either the base-line period (2, 0, 0, 0, and 2 percent, respectively; P less than 0.05) or the caffeine period (3, 2, 2, 0, and 6 percent; P less than 0.05). More subjects reported unauthorized use of medications during the placebo period (13 percent) than during the caffeine period (2 percent, P = 0.017). Performance of a tapping task was slower during the placebo period than during the base-line and caffeine periods (P less than 0.01). Persons who consume low or moderate amounts of caffeine may have a withdrawal syndrome after their daily consumption of caffeine ceases.

Effect of 0.3% Hydroxypropyl Methylcellulose/Dextran Versus 0.18% Sodium Hyaluronate in the Treatment of Ocular Surface Disease in Glaucoma Patients: A Randomized, Double-Blind, and Controlled Study.

PubMed

Prabhasawat, Pinnita; Ruangvaravate, Ngamkae; Tesavibul, Nattaporn; Thewthong, Maneerat

2015-01-01

To compare the efficacy and safety of 0.3% hydroxypropyl methylcellulose/dextran (HPMC/dextran) and 0.18% sodium hyaluronate (SH) in the treatment of ocular surface disease in patients using antiglaucoma drugs containing preservatives. This was a double-blind, randomized, parallel-group study in 70 glaucoma patients with Ocular Surface Disease Index (OSDI) score greater than 20 points and/or presence of ocular signs. Patients were randomized to receive either preservative-free 0.3% HPMC/dextran (n=35) or preservative-free 0.18% SH (n=35). Treatment was 1 drop in each eye, 4 times a day. Data were collected at baseline, at day 7 and day 28. The groups were homogeneous at baseline. At day 28, both treatments showed significant improvements (P<0.05) in the mean OSDI score, lid skin and lid margin inflammation, conjunctival injection, and expressibility of meibomian glands, corneal staining score, fluorescein tear breakup time (FBUT), and Schirmer I test. However, the mean OSDI score, lid margin inflammation and conjunctival injection showed significant improvements (P<0.05) in the SH group at days 7 and 28, compared to the HPMC/dextran group. FBUT and the Schirmer I test also showed significant improvements (P<0.05) in the SH group compared to the HPMC/dextran group, at day 28. No adverse reactions were observed in either group. Preservative-free artificial tear, 0.3% HPMC/dextran, and 0.18% SH, caused a significant relief of the ocular surface disease in glaucoma patients. However, 0.18% SH led to a greater improvement in ocular signs and symptoms than 0.3% HPMC/dextran.

Validation of a Projection-domain Insertion of Liver Lesions into CT Images

PubMed Central

Chen, Baiyu; Ma, Chi; Leng, Shuai; Fidler, Jeff L.; Sheedy, Shannon P.; McCollough, Cynthia H.; Fletcher, Joel G.; Yu, Lifeng

2016-01-01

Rationale and Objectives The aim of this study was to validate a projection-domain lesion-insertion method with observer studies. Materials and Methods A total of 51 proven liver lesions were segmented from computed tomography images, forward projected, and inserted into patient projection data. The images containing inserted and real lesions were then reconstructed and examined in consensus by two radiologists. First, 102 lesions (51 original, 51 inserted) were viewed in a randomized, blinded fashion and scored from 1 (absolutely inserted) to 10 (absolutely real). Statistical tests were performed to compare the scores for inserted and real lesions. Subsequently, a two-alternative-forced-choice test was conducted, with lesions viewed in pairs (real vs. inserted) in a blinded fashion. The radiologists selected the inserted lesion and provided a confidence level of 1 (no confidence) to 5 (completely certain). The number of lesion pairs that were incorrectly classified was calculated. Results The scores for inserted and proven lesions had the same median (8) and similar interquartile ranges (inserted, 5.5–8; real, 6.5–8). The means scores were not significantly different between real and inserted lesions (P value = 0.17). The receiver operating characteristic curve was nearly diagonal, with an area under the curve of 0.58 ± 0.06. For the two-alternative-forced-choice study, the inserted lesions were incorrectly identified in 49% (25 out of 51) of pairs; radiologists were incorrect in 38% (3 out of 8) of pairs even when they felt very confident in identifying the inserted lesion (confidence level ≥4). Conclusions Radiologists could not distinguish between inserted and real lesions, thereby validating the lesion-insertion technique, which may be useful for conducting virtual clinical trials to optimize image quality and radiation dose. PMID:27432267

Safety and Efficacy of ARA 290 in Sarcoidosis Patients with Symptoms of Small Fiber Neuropathy: A Randomized, Double-Blind Pilot Study

PubMed Central

Heij, Lara; Niesters, Marieke; Swartjes, Maarten; Hoitsma, Elske; Drent, Marjolein; Dunne, Ann; Grutters, Jan C; Vogels, Oscar; Brines, Michael; Cerami, Anthony; Dahan, Albert

2012-01-01

ARA 290 (a peptide designed to activate the innate repair receptor that arrests injury and initiates cytoprotection, antiinflammation and healing) reduces allodynia in preclinical neuropathy models. We studied the safety and efficacy of ARA 290 to reduce symptoms of small fiber neuropathy (SFN) in patients with sarcoidosis. A total of 22 patients diagnosed with sarcoidosis and symptoms of SFN were enrolled in a double-blind, placebo-controlled exploratory trial consisting of three times weekly intravenous dosing of ARA 290 (2 mg; n = 12) or placebo (n = 10) for 4 wks. Inclusion criteria were a diagnosis of neuropathy and a spontaneous pain score of ≥5 (Brief Pain Inventory [BPI]). Endpoints assessed were changes in pain intensity and the small fiber neuropathy screening list (SFNSL) score, quality of life (SF-36), depressive symptoms (Inventory of Depressive Symptomatology [IDS]) and fatigue (Fatigue Assessment Scale [FAS]). No safety concerns were raised by clinical or laboratory assessments. The ARA 290 group showed significant (p < 0.05) improvement at wk 4 in SFNSL score compared with placebo (Δ −11.5 ± 3.04 versus Δ −2.9 ± 3.34 [standard error of the mean]). Additionally, the ARA 290 group showed a significant change from baseline in the pain and physical functioning dimensions of the SF-36 (Δ −23.4 ± 5.5 and Δ −14.6 ± 3.9, respectively). The mean BPI and FAS scores improved significantly but equivalently in both patient groups. No change was observed in the IDS. ARA 290 appears to be safe in patients with sarcoidosis and can reduce neuropathic symptoms. PMID:23168581

Automatic diabetic retinopathy classification

NASA Astrophysics Data System (ADS)

Bravo, María. A.; Arbeláez, Pablo A.

2017-11-01

Diabetic retinopathy (DR) is a disease in which the retina is damaged due to augmentation in the blood pressure of small vessels. DR is the major cause of blindness for diabetics. It has been shown that early diagnosis can play a major role in prevention of visual loss and blindness. This work proposes a computer based approach for the detection of DR in back-of-the-eye images based on the use of convolutional neural networks (CNNs). Our CNN uses deep architectures to classify Back-of-the-eye Retinal Photographs (BRP) in 5 stages of DR. Our method combines several preprocessing images of BRP to obtain an ACA score of 50.5%. Furthermore, we explore subproblems by training a larger CNN of our main classification task.

Maintenance N-acetyl cysteine treatment for bipolar disorder: A double-blind randomized placebo controlled trial

PubMed Central

2012-01-01

Background N-acetyl cysteine (NAC) is a glutathione precursor that has been shown to have antidepressant efficacy in a placebo-controlled trial. The current study aimed to investigate the maintenance effects of NAC following eight weeks of open-label treatment for bipolar disorder. Method The efficacy of a double blind randomized placebo controlled trial of 2 g/day NAC as adjunct maintenance treatment for bipolar disorder was examined. Participants (n = 149) had a Montgomery Asberg Depression Rating Score of ≥12 at trial entry and, after eight weeks of open-label NAC treatment, were randomized to adjunctive NAC or placebo, in addition to treatment as usual. Participants (primarily outpatients) were recruited through public and private services and through newspaper advertisements. Time to intervention for a mood episode was the primary endpoint of the study, and changes in mood symptoms, functionality and quality of life measures were secondary outcomes. Results There was a substantial decrease in symptoms during the eight-week open-label NAC treatment phase. During the subsequent double-blind phase, there was minimal further change in outcome measures with scores remaining low. Consequently, from this low plateau, between-group differences did not emerge on recurrence, clinical functioning or quality of life measures. Conclusions There were no significant between-group differences in recurrence or symptomatic outcomes during the maintenance phase of the trial; however, these findings may be confounded by limitations. Trial Registration The trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12607000074493). PMID:22891797

A pilot single-blind multicentre randomized controlled trial to evaluate the potential benefits of computer-assisted arm rehabilitation gaming technology on the arm function of children with spastic cerebral palsy.

PubMed

Preston, Nick; Weightman, Andrew; Gallagher, Justin; Levesley, Martin; Mon-Williams, Mark; Clarke, Mike; O'Connor, Rory J

2016-10-01

To evaluate the potential benefits of computer-assisted arm rehabilitation gaming technology on arm function of children with spastic cerebral palsy. A single-blind randomized controlled trial design. Power calculations indicated that 58 children would be required to demonstrate a clinically important difference. Intervention was home-based; recruitment took place in regional spasticity clinics. A total of 15 children with cerebral palsy aged five to 12 years were recruited; eight to the device group. Both study groups received 'usual follow-up treatment' following spasticity treatment with botulinum toxin; the intervention group also received a rehabilitation gaming device. ABILHAND-kids and Canadian Occupational Performance Measure were performed by blinded assessors at baseline, six and 12 weeks. An analysis of covariance showed no group differences in mean ABILHAND-kids scores between time points. A non-parametric analysis of variance on Canadian Occupational Performance Measure scores showed a statistically significant improvement across time points (χ 2 (2,15) = 6.778, p = 0.031), but this improvement did not reach minimal clinically important difference. Mean daily device use was seven minutes. Recruitment did not reach target owing to unanticipated staff shortages in clinical services. Feedback from children and their families indicated that the games were not sufficiently engaging to promote sufficient use that was likely to result in functional benefits. This study suggests that computer-assisted arm rehabilitation gaming does not benefit arm function, but a Type II error cannot be ruled out. © The Author(s) 2015.

Emotional wellbeing of blind patients in a pilot trial with subretinal implants.

PubMed

Peters, Tobias; Klingberg, Stefan; Zrenner, Eberhart; Wilhelm, Barbara

2013-06-01

Participation in first human applications of retinal neuroprosthesis may create psychological stress for blind retinitis pigmentosa patients. The aim of this study was to assess the emotional wellbeing of patients undergoing implantation of a subretinal implant. Nine blind patients participating in a pilot trial with subretinal implants were enlisted. The Brief Symptom Inventory (BSI), a short self-report scale of nine primary symptoms, was used to assess reaction to the psychological distress related to study participation. The number and the intensity of symptoms were analysed, and global scores for overall psychological distress (tGSI), severity of reported symptoms (tPDSI), and level number of self-reported symptoms (tPST) were calculated. The questionnaire was administered before implantation, 2-3 times during the trial and before explantation. There were no significant alterations during the trial for the average scores of the nine primary symptoms. One patient, however, showed values higher than the norm, for six subscores before implantation and for eight subscores before explantation. A significant improvement was found in both the overall psychological distress level (tGSI) and the severity of reported symptoms (tPDSI) at the final visit, compared to those at the study start. The number of self-reported symptoms (tPST) was not significantly altered. In the first ongoing pilot trial with an active, cable-bound subretinal implant, we found that trial participation and the implant procedure and subsequent testing did not have any adverse effects on the participants' emotional wellbeing. Their distress generally improved during study participation, rather than showing signs of decreased wellbeing.

Fructan, Rather Than Gluten, Induces Symptoms in Patients With Self-Reported Non-Celiac Gluten Sensitivity.

PubMed

Skodje, Gry I; Sarna, Vikas K; Minelle, Ingunn H; Rolfsen, Kjersti L; Muir, Jane G; Gibson, Peter R; Veierød, Marit B; Henriksen, Christine; Lundin, Knut E A

2018-02-01

Non-celiac gluten sensitivity is characterized by symptom improvement after gluten withdrawal in absence of celiac disease. The mechanisms of non-celiac gluten sensitivity are unclear, and there are no biomarkers for this disorder. Foods with gluten often contain fructans, a type of fermentable oligo-, di-, monosaccharides and polyols. We aimed to investigate the effect of gluten and fructans separately in individuals with self-reported gluten sensitivity. We performed a double-blind crossover challenge of 59 individuals on a self-instituted gluten-free diet, for whom celiac disease had been excluded. The study was performed at Oslo University Hospital in Norway from October 2014 through May 2016. Participants were randomly assigned to groups placed on diets containing gluten (5.7 g), fructans (2.1 g), or placebo, concealed in muesli bars, for 7 days. Following a minimum 7-day washout period (until the symptoms induced by the previous challenge were resolved), participants crossed over into a different group, until they completed all 3 challenges (gluten, fructan, and placebo). Symptoms were measured by Gastrointestinal Symptom Rating Scale Irritable Bowel Syndrome (GSRS-IBS) version. A linear mixed model for analysis was used. Overall GSRS-IBS scores differed significantly during gluten, fructan, and placebo challenges; mean values were 33.1 ± 13.3, 38.6 ± 12.3, and 34.3 ± 13.9, respectively (P = .04). Mean scores for GSRS-IBS bloating were 9.3 ± 3.5, 11.6 ± 3.5, and 10.1 ± 3.7, respectively, during the gluten, fructan, and placebo challenges (P = .004). The overall GSRS-IBS score for participants consuming fructans was significantly higher than for participants consuming gluten (P = .049), as was the GSRS bloating score (P = .003). Thirteen participants had the highest overall GSRS-IBS score after consuming gluten, 24 had the highest score after consuming fructan, and 22 had the highest score after consuming placebo. There was no difference in GSRS-IBS scores between gluten and placebo groups. In a randomized, double-blind, placebo-controlled crossover study of individuals with self-reported non-celiac gluten sensitivity, we found fructans to induce symptoms, measured by the GSRS-IBS. Clinicaltrials.gov no: NCT02464150. Copyright © 2018 AGA Institute. Published by Elsevier Inc. All rights reserved.

Comparison of Glucosamine-Chondroitin Sulfate with and without Methylsulfonylmethane in Grade I-II Knee Osteoarthritis: A Double Blind Randomized Controlled Trial.

PubMed

Lubis, Andri M T; Siagian, Carles; Wonggokusuma, Erick; Marsetyo, Aldo F; Setyohadi, Bambang

2017-04-01

Glucosamine, chondroitinsulfate are frequently used to prevent further joint degeneration in osteoarthritis (OA). Methylsulfonylmethane (MSM) is a supplement containing organic sulphur and also reported to slow anatomical joint progressivity in the knee OA. The MSM is often combined with glucosamine and chondroitin sulfate. However, there are controversies whether glucosamine-chondroitin sulfate or their combination with methylsulfonylmethane could effectively reduce pain in OA. This study is aimed to compare clinical outcome of glucosamine-chondroitin sulfate (GC), glucosamine-chondroitin sulfate-methylsulfonylmethane (GCM), and placeboin patients with knee osteoarthritis (OA) Kellgren-Lawrence grade I-II. a double blind, randomized controlled clinical trial was conducted on 147 patients with knee OA Kellgren-Lawrence grade I-II. Patients were allocated by permuted block randomization into three groups: GC (n=49), GCM (n=50), or placebo (n=48) groups. GC group received 1500 mg of glucosamine + 1200 mg of chondroitin sulfate + 500 mg of saccharumlactis; GCM group received 1500 mg of glucosamine + 1200 mg of chondroitin sulfate + 500 mg of MSM; while placebo group received three matching capsules of saccharumlactis. The drugs were administered once daily for 3 consecutive months VAS and WOMAC scores were measured before treatment, then at 4th, 8th and 12th week after treatment. on statistical analysis it was found that at the 12th week, there are significant difference between three treatment groups on the WOMAC score (p=0.03) and on the VAS score (p=0.004). When analyzed between weeks, GCM treatment group was found statistically significant on WOMAC score (p=0.01) and VAS score (p<0.001). Comparing the score difference between weeks, WOMAC score analysis showed significant difference between GC, GCM, and placebo in week 4 (p=0.049) and week 12 (p=0.01). In addition, VAS score also showed significant difference between groups in week 8 (p=0.006) and week 12 (p<0.001). combination of glucosamine-chondroitinsulfate-methylsulfonylmethane showed clinical benefit for patients with knee OAK ellgren-Lawrence grade I-II compared with GC and placebo. GC did not make clinical improvement in overall groups of patients with knee OA Kellgren Lawrence grade I-II.

The Addenbrooke's Cognitive Examination Revised (ACE-R) and its sub-scores: normative values in an Italian population sample.

PubMed

Siciliano, Mattia; Raimo, Simona; Tufano, Dario; Basile, Giuseppe; Grossi, Dario; Santangelo, Franco; Trojano, Luigi; Santangelo, Gabriella

2016-03-01

The Addenbrooke's Cognitive Examination Revised (ACE-R) is a rapid screening battery, including five sub-scales to explore different cognitive domains: attention/orientation, memory, fluency, language and visuospatial. ACE-R is considered useful in discriminating cognitively normal subjects from patients with mild dementia. The aim of present study was to provide normative values for ACE-R total score and sub-scale scores in a large sample of Italian healthy subjects. Five hundred twenty-six Italian healthy subjects (282 women and 246 men) of different ages (age range 20-93 years) and educational level (from primary school to university) underwent ACE-R and Montreal Cognitive Assessment (MoCA). Multiple linear regression analysis revealed that age and education significantly influenced performance on ACE-R total score and sub-scale scores. A significant effect of gender was found only in sub-scale attention/orientation. From the derived linear equation, a correction grid for raw scores was built. Inferential cut-offs score were estimated using a non-parametric technique and equivalent scores (ES) were computed. Correlation analysis showed a good significant correlation between ACE-R adjusted scores with MoCA adjusted scores (r = 0.612, p < 0.001). The present study provided normative data for the ACE-R in an Italian population useful for both clinical and research purposes.

Sarizotan as a treatment for dyskinesias in Parkinson's disease: a double-blind placebo-controlled trial.

PubMed

Goetz, Christopher G; Damier, Philippe; Hicking, Christine; Laska, Eugene; Müller, Thomas; Olanow, C Warren; Rascol, Olivier; Russ, Hermann

2007-01-15

The objective of this study is to conduct a dose-finding study of sarizotan in Parkinson's disease (PD) patients with dyskinesia to identify a safe dose and to identify a sensitive dyskinesia rating measure. Sarizotan is a novel compound with full 5-HT(1A) agonist properties and additional high affinity for D(3) and D(4) receptors. An open label study documented improvements in PD patients with levodopa-induced dyskinesia. There is no precedent for study designs or outcome measures in pivotal trials of antidyskinesia therapies. The approach used here was a multicenter, randomized, placebo-controlled, double-blind, parallel study. Included were PD patients optimized to levodopa and dopaminergic drugs with moderately disabling dyskinesias present greater than or equal to 25% of the waking day. Interventions included sarizotan 2, 4, or 10 mg/day or matching placebo, given in two doses. There were two outcome measures: the primary measure was change from baseline in diary-based on time without dyskinesia; the secondary measures were change from baseline in scores on the Abnormal Involuntary Movement Scale (AIMS), the composite score of Unified Parkinson's Disease Rating Scale (UPDRS) Items 32+33 (dyskinesia duration and disability) and total UPDRS. A total of 398 subjects were randomized, with 381 included in the intention-to-treat population. No significant changes occurred on sarizotan compared to placebo on any diary-based measure of dyskinesia or the AIMS score. The composite score of UPDRS Items 32+33 was significantly improved with 2 mg/day sarizotan, with a trend at 10 mg/day. Adverse events were not significantly different in sarizotan- and placebo-treated patients, but off time significantly increased with sarizotan 10 mg/day. Sarizotan 2 mg/day is a safe agent in PD patients with dyskinesia. To test its role in abating dyskinesia, future studies should focus on this dose and will use the composite score of UPDRS Items 32+33 as the primary outcome. (c) 2006 Movement Disorder Society.

Osteochondral Biopsy Analysis Demonstrates That BST-CarGel Treatment Improves Structural and Cellular Characteristics of Cartilage Repair Tissue Compared With Microfracture

PubMed Central

Méthot, Stéphane; Changoor, Adele; Tran-Khanh, Nicolas; Hoemann, Caroline D.; Stanish, William D.; Restrepo, Alberto; Shive, Matthew S.; Buschmann, Michael D.

2016-01-01

Objective The efficacy and safety of BST-CarGel, a chitosan-based medical device for cartilage repair, was compared with microfracture alone at 1 year during a multicenter randomized controlled trial (RCT) in the knee. The quality of repair tissue of osteochondral biopsies collected from a subset of patients was compared using blinded histological assessments. Methods The international RCT evaluated repair tissue quantity and quality by 3-dimensional quantitative magnetic resonance imaging as co-primary endpoints at 12 months. At an average of 13 months posttreatment, 21/41 BST-CarGel and 17/39 microfracture patients underwent elective second look arthroscopies as a tertiary endpoint, during which ICRS (International Cartilage Repair Society) macroscopic scoring was carried out, and osteochondral biopsies were collected. Stained histological sections were evaluated by blinded readers using ICRS I and II histological scoring systems. Collagen organization was evaluated using a polarized light microscopy score. Results BST-CarGel treatment resulted in significantly better ICRS macroscopic scores (P = 0.0002) compared with microfracture alone, indicating better filling, integration, and tissue appearance. Histologically, BST-CarGel resulted in a significant improvement of structural parameters—Surface Architecture (P = 0.007) and Surface/Superficial Assessment (P = 0.042)—as well as cellular parameters—Cell Viability (P = 0.006) and Cell Distribution (P = 0.032). No histological parameters were significantly better for the microfracture group. BST-CarGel treatment also resulted in a more organized repair tissue with collagen stratification more similar to native hyaline cartilage, as measured by polarized light microscopy scoring (P = 0.0003). Conclusion Multiple and independent analyses in this biopsy substudy demonstrated that BST-CarGel treatment results in improved structural and cellular characteristics of repair tissue at 1 year posttreatment compared with microfracture alone, supporting previously reported results by quantitative magnetic resonance imaging. PMID:26958314

Granisetron as an add-on to risperidone for treatment of negative symptoms in patients with stable schizophrenia: randomized double-blind placebo-controlled study.

PubMed

Khodaie-Ardakani, Mohammad-Reza; Seddighi, Sahar; Modabbernia, Amirhossein; Rezaei, Farzin; Salehi, Bahman; Ashrafi, Mandana; Shams-Alizadeh, Narges; Mohammad-Karimi, Maryam; Esfandiari, Gholam-Reza; Hajiaghaee, Reza; Akhondzadeh, Shahin

2013-04-01

Some 5-HT3 antagonists such as ondansetron have shown beneficial effects on negative symptoms of patients with schizophrenia. We aimed to evaluate the efficacy of granisetron (another 5-HT3 antagonist) add-on therapy in the treatment of negative symptoms of patients with stable schizophrenia. In a randomized, double-blind, and placebo-controlled study, forty stable patients with schizophrenia (DSM-IV-TR), were randomized to either granisetron (1 mg twice daily) or placebo (twice daily) in addition to risperidone up to 6 mg/day for eight weeks. The patients were assessed using positive and negative syndrome scale (PANSS) and extrapyramidal symptom rating scale (ESRS) at baseline, week 4 and 8. Hamilton depression rating scale (HDRS) was used to assess depression at baseline and week 8. Thirty-eight patients completed the trial. Granisetron group showed a significantly greater improvement on negative subscale than the placebo group at endpoint [t(38) = 6.046, mean difference (±95% CI) = 3.2(1.8-3.7), P < 0.001]. The same effect was observed for total score [t(38) = 4.168, mean difference (95% CI) = 3.2(1.6-4.7), P < 0.001]. However the placebo and granisetron groups did not differ in their reduction of positive and general psychopathology symptoms scores. HDRS scores and its changes did not differ between the two groups. The ESRS score at week 4 was significantly lower in the granisetron than the placebo group while the two groups showed similar ESRS score at week 8. Frequency of other side effects was similar between the two groups. In summary, granisetron add-on can safely and effectively reduce the primary negative symptoms of patients with schizophrenia. Copyright © 2013 Elsevier Ltd. All rights reserved.

Single-injection femoral nerve block. Effects on the independence level in functional activities in the early postoperative period in patients with total knee arthroplasty.

PubMed

Tugay, Nazan; Saricaoglu, Fatma; Satilmis, Tulin; Alpar, Ulku; Akarcali, Inci; Citaker, Seyit; Tugay, Umut; Atilla, Bulent; Tokgozoglu, Mazhar

2006-07-01

To investigate the efficacy of single injection femoral nerve block (FNB) on the independence level in functional activities in the early postoperative period in patients with total knee arthroplasty (TKA). We conducted this prospective, randomized, blinded trial in the Department of Orthopedics and Traumatology, Hacettepe University Hospital Ankara, Turkey, between June 2003 and April 2004. Twenty-three patients scheduled for elective TKA were randomly divided into 3 groups. Group I received preemptive single injection FNB, group II received postoperative single injection FNB, and group III served as a control group. Intravenous morphine patient controlled analgesia (PCA) was used following surgery in all groups. Morphine dose and pain score defined by the visual analog scale (VAS) were recorded postoperatively at the 15th minute, 30th minute, 1st, 4th, 6th, 12th, 24th, and 48th hours. A standard rehabilitation protocol was applied for all patients. The independence level in functional activities was assessed during the first 2 postoperative days and at discharge with the Iowa Level of Assistance Scale (ILAS) and the Iowa Ambulation Speed Scale (IASS). Physical therapists that enrolled in the study were blinded to the groups. Pain scores were significantly different between the groups (p<0.05). The preemptive and postoperative FNB group`s VAS scores were both significantly lower than the control group (p<0.05). However, there was no significant difference in VAS scores between preemptive and postoperative FNB groups (p>0.05). There was no statistically significant difference between the groups in any of the functional scores in the first 2 postoperative days, and at discharge (p>0.05). Single injection FNB provided effective analgesia in patients undergoing TKA. However, the independence level in functional activities in the early postoperative period was not influenced by the analgesia method.

Randomized double-blind trial comparing the cosmetic outcome of cutting diathermy versus scalpel for skin incisions.

PubMed

Aird, L N F; Bristol, S G; Phang, P T; Raval, M J; Brown, C J

2015-04-01

Controversy exists about whether cutting diathermy for skin incisions leads to a cosmetically inferior scar. Cosmetic outcomes were compared between skin incisions created with cutting diathermy versus scalpel. Wound infection rates and postoperative incisional pain were also compared. This was a randomized double-blind trial comparing cutting diathermy and scalpel in patients undergoing bowel resection. Scar cosmesis was assessed at 6 months after surgery by a plastic surgeon and a research associate using the Vancouver Scar Scale (VSS) and the Patient and Observer Scar Assessment Scale (POSAS). Patients also used POSAS to self-evaluate their scars. Wound infections within 30 days were recorded, and incision pain scores were measured on the first 5 days after operation. A total of 66 patients were randomized to cutting diathermy (31) or scalpel (35). At 6 months, there was no significant difference between the diathermy and scalpel groups in mean(s.d.) VSS scores (4·9(2·6) versus 5·0(1·9); P = 0·837), mean POSAS total scores (19·2(8·0) versus 20·0(7·4); P = 0·684) or subjective POSAS total scores (20·2(12·1) versus 21·3(10·4); P = 0·725). Neither were there significant differences in wound infection rates between the groups (5 of 30 versus 5 of 32; P = 1·000). Pain scores on day 1 after operation were significantly lower in the diathermy group (mean 1·68 versus 3·13; P = 0·018), but were not significantly different on days 2-5. Cutting diathermy is a cosmetically acceptable technique for abdominal skin incisions. There is no increased risk of wound infection, and diathermy may convey benefit in terms of early postoperative wound pain. NCT01496404 ( http://www.clinicaltrials.gov). © 2015 BJS Society Ltd Published by John Wiley & Sons Ltd.

Sodium Benzoate, a D-Amino Acid Oxidase Inhibitor, Added to Clozapine for the Treatment of Schizophrenia: A Randomized, Double-Blind, Placebo-Controlled Trial.

PubMed

Lin, Chieh-Hsin; Lin, Ching-Hua; Chang, Yue-Cune; Huang, Yu-Jhen; Chen, Po-Wei; Yang, Hui-Ting; Lane, Hsien-Yuan

2017-12-26

Clozapine is the last-line antipsychotic agent for refractory schizophrenia. To date, there is no convincing evidence for augmentation on clozapine. Activation of N-methyl-D-aspartate receptors, including inhibition of D-amino acid oxidase that may metabolize D-amino acids, has been reported to be beneficial for patients receiving antipsychotics other than clozapine. This study aimed to examine the efficacy and safety of a D-amino acid oxidase inhibitor, sodium benzoate, for schizophrenia patients who had poor response to clozapine. We conducted a randomized, double-blind, placebo-controlled trial. Sixty schizophrenia inpatients that had been stabilized with clozapine were allocated into three groups for 6 weeks' add-on treatment of 1 g/day sodium benzoate, 2 g/day sodium benzoate, or placebo. The primary outcome measures were Positive and Negative Syndrome Scale (PANSS) total score, Scale for the Assessment of Negative Symptoms, Quality of Life Scale, and Global Assessment of Functioning. Side effects and cognitive functions were also measured. Both doses of sodium benzoate produced better improvement than placebo in the Scale for the Assessment of Negative Symptoms. The 2 g/day sodium benzoate also produced better improvement than placebo in PANSS-total score, PANSS-positive score, and Quality of Life Scale. Sodium benzoate was well tolerated without evident side effects. The changes of catalase, an antioxidant, were different among the three groups and correlated with the improvement of PANSS-total score and PANSS-positive score in the sodium benzoate group. Sodium benzoate adjuvant therapy improved symptomatology of patients with clozapine-resistant schizophrenia. Further studies are warranted to elucidate the optimal dose and treatment duration as well as the mechanisms of sodium benzoate for clozapine-resistant schizophrenia. Copyright © 2017 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.

Effects of Febuxostat in Early Gout: A Randomized, Double-Blind, Placebo-Controlled Study.

PubMed

Dalbeth, Nicola; Saag, Kenneth G; Palmer, William E; Choi, Hyon K; Hunt, Barbara; MacDonald, Patricia A; Thienel, Ulrich; Gunawardhana, Lhanoo

2017-12-01

To assess the effect of treatment with febuxostat versus placebo on joint damage in hyperuricemic subjects with early gout (1 or 2 gout flares). In this double-blind, placebo-controlled study, 314 subjects with hyperuricemia (serum uric acid [UA] level of ≥7.0 mg/dl) and early gout were randomized 1:1 to receive once-daily febuxostat 40 mg (increased to 80 mg if the serum UA level was ≥6.0 mg/dl on day 14) or placebo. The primary efficacy end point was the mean change from baseline to month 24 in the modified Sharp/van der Heijde erosion score for the single affected joint. Additional efficacy end points included change from baseline to month 24 in the Rheumatoid Arthritis Magnetic Resonance Imaging Scoring (RAMRIS) scores for synovitis, erosion, and edema in the single affected joint, the incidence of gout flares, and serum UA levels. Safety was assessed throughout the study. Treatment with febuxostat did not lead to any notable changes in joint erosion over 2 years. In both treatment groups, the mean change from baseline to month 24 in the modified Sharp/van der Heijde erosion score for the single affected joint was minimal, with no between-group differences. However, treatment with febuxostat significantly improved the RAMRIS synovitis score at month 24 compared with placebo treatment (change from baseline -0.43 versus -0.07; P <0.001), decreased the overall incidence of gout flares (29.3% versus 41.4%; P < 0.05), and improved serum UA control (62.8% versus 5.7%; P < 0.001). No major safety concerns were reported. Urate-lowering therapy with febuxostat improved magnetic resonance imaging-determined synovitis and reduced the incidence of gout flares in subjects with early gout. © 2017 The Authors. Arthritis & Rheumatology published by Wiley Periodicals, Inc. on behalf of American College of Rheumatology.

Effects of So-cheong-ryong-tang and Yeon-gyo-pae-dok-san on the common cold: randomized, double blind, placebo controlled trial.

PubMed

Byun, Jun-Seop; Yang, Su-Young; Jeong, In-Cheol; Hong, Kwon-Eui; Kang, Weechang; Yeo, Yoon; Park, Yang-Chun

2011-01-27

So-cheong-ryong-tang (SCRT) and Yeon-gyo-pae-dok-san (YPS) extracts are widely used in treatment of the common cold. The purpose of this study is to evaluate the efficacy of SCRT and YPS on the common cold. Four hundred eighty participants with symptoms of the common cold within 48 h were recruited for this randomized, double-blind, placebo-controlled trial. SCRT extract and YPS extract were put in gelatin capsules and orally administered 3 times a day. The pattern of participants was determined according to the Questionnaire for Common Cold Pattern Identification (QCCPI), and the severity of illness was assessed by Wisconsin Upper Respiratory Symptom Survey-21 Korean version (WURSS-21-K) every 7 days. The test and control groups were not significantly different in gender, age, smoking history, and baseline score of WURSS-21-K at the time of enrollment. SCRT treatment significantly decreased the total WURSS-21-K score on the 6th and 7th day (p<0.05) of the enrollment compared with the placebo group. YPS treatment decreased the total WURSS-21-K score on the 5th and 6th day (p<0.05 vs. the placebo group) of the enrollment. In the patients with Wind-cold pattern cold, SCRT significantly decreased the total WURSS-21-K score from 4th to 8th day (p<0.05), and YPS significantly decreased the total WURSS-21-K score from 4th to 6th day (p<0.05). For the Wind-heat pattern cold, neither SCRT nor YPS group showed significant difference from the placebo group. SCRT and YPS did not significantly decrease the time to complete resolution of the cold symptoms. SCRT and YPS have beneficial, albeit limited, effects on common cold patients, especially those with the Wind-cold pattern cold. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

Are blind people more likely to accept free cataract surgery? A study of vision-related quality of life and visual acuity in Kenya.

PubMed

Briesen, Sebastian; Roberts, Helen; Ilako, Dunera; Karimurio, Jefitha; Courtright, Paul

2010-01-01

To determine possible differences in visual acuity, socio-demographic factors and vision-related Quality of Life (QoL) between people accepting and people refusing sponsored cataract surgery. Three hundred and fifty seven local residents with visually impairing cataract, presenting at screening sites in Kwale District, Kenya were clinically assessed and interviewed. The World Health Organization (WHO) QoL-questionnaire WHO/Prevention of Blindness and Deafness Visual Functioning Questionnaire 20 (PBD-VFQ20) was used to determine the vision-related QoL. A standardized questionnaire asked for socio-demographic data and prior cataract surgery in one eye. After interview, patients were offered free surgery. Primary outcome was the mean QoL-score between acceptors and non-acceptors. Secondary outcomes were visual acuity and socio-demographic factors and their contribution to QoL-scores and the decision on acceptance or refusal. Fifty nine people (16.5%) refused and 298 accepted cataract surgery. Vision-related QoL was poorer in people accepting than in those refusing (mean score 51.54 and 43.12 respectively). People with poor visual acuity were only slightly more likely to accept surgery than people with better vision; the strongest predictors of acceptance were the QoL-score and gender. Men were twice as likely to accept compared to women. Of people who accepted surgery, 73.8% had best eye vision of 20/200 or better. In this population, visual acuity was of limited use to predict a person's decision to accept or refuse cataract surgery. QoL-scores provide further insight into which individuals will agree to surgery and it might be useful to adapt the QoL-questions for field use. Gender inequities remain a matter of concern with men being more likely to get sight-restoring surgery.

Comparison of Symptomatic versus Functional Changes in Children and Adolescents with ADHD during Randomized, Double-Blind Treatment with Psychostimulants, Atomoxetine, or Placebo

ERIC Educational Resources Information Center

Buitelaar, Jan K.; Wilens, Timothy E.; Zhang, Shuyu; Ning, Yu; Feldman, Peter D.

2009-01-01

Background: This meta-analysis was designed to determine the relationship between reduction of attention-deficit/hyperactivity disorder (ADHD) symptoms and improvement in functioning by examining short-term changes in functional and symptomatic scores in children and adolescents with ADHD. Methods: Search of atomoxetine's clinical trial database…

When a ''Sloppy Copy'' Is Good Enough: Results of a State Writing Assessment

ERIC Educational Resources Information Center

Crawford, Lindy; Smolkowski, Keith

2008-01-01

Students in grades 5 and 8 completed a state writing assessment, and their first and final drafts on the extended writing portion of the test were copied and scored using the state writing rubric. The rubric consisted of three primary traits: Content and Organization, Style and Fluency, and Language Use. Scorers were blind to the study purpose and…

A Double-Blind, Active-Controlled Clinical Trial of Sodium Bicarbonate and Calcium Gluconate in the Treatment of Bilateral Osteoarthritis of the Knee.

PubMed

Caamaño, María Del Carmen; García-Padilla, Sandra; Duarte-Vázquez, Miguel Ángel; González-Romero, Karla Elena; Rosado, Jorge L

2017-01-01

To evaluate the effect of intra-articular injections of sodium bicarbonate with a single (SBCG1) or double dose (SBCG2) of calcium gluconate administered monthly compared with methylprednisolone (MP) for treatment of knee osteoarthritis. A 3-month, randomized, double-blind clinical trial with patients diagnosed with knee osteoarthritis (OA). The outcome variables were the Western Ontario-McMaster University Osteoarthritis Index (WOMAC) and the Lequesne functional index. After 3 months, all treatments significantly improved in overall WOMAC and Lequesne scores. Mean changes (95% confidence interval) in WOMAC total score and the Lequesne index, respectively, for SBCG1 (-12.5 [-14.3, -10.7]; -9.0 [-11.4, -6.7]) and SBCG2 (-12.3 [-14.3, -10.4]; -8.9 [-10.4, -7.4]) were significantly greater than for MP (-5.0 [-7.2, -2.8]; -3.2 [-4.9, -1.5]) ( P < .001). Intra-articular injections of sodium bicarbonate and calcium gluconate are useful for short-term relief of OA symptoms in patients with bilateral knee osteoarthritis. Both treatments are more effective than MP injections in the reduction of knee OA symptoms. Clinicaltrials.gov NCT00977444.

Systematic review of communication partner training in aphasia: methodological quality.

PubMed

Cherney, Leora R; Simmons-Mackie, Nina; Raymer, Anastasia; Armstrong, Elizabeth; Holland, Audrey

2013-10-01

Twenty-three studies identified from a previous systematic review examining the effects of communication partner training on persons with aphasia and their communication partners were evaluated for methodological quality. Two reviewers rated the studies on defined methodological quality criteria relevant to each study design. There were 11 group studies, seven single-subject participant design studies, and five qualitative studies. Quality scores were derived for each study. The mean inter-rater reliability of scores for each study design ranged from 85-93%, with Cohen's Kappa indicating substantial agreement between raters. Methodological quality of research on communication partner training in aphasia was highly varied. Overall, group studies employed the least rigorous methodology as compared to single subject and qualitative research. Only two of 11 group studies complied with more than half of the quality criteria. No group studies reported therapist blinding and only one group study reported participant blinding. Across all types of studies, the criterion of treatment fidelity was most commonly omitted. Failure to explicitly report certain methodological quality criteria may account for low ratings. Using methodological rating scales specific to the type of study design may help improve the methodological quality of aphasia treatment studies, including those on communication partner training.

[Clinical study of tissue-selecting therapy in the treatment of mixed hemorrhoids: a single-blind randomized controlled trail].

PubMed

He, Hongyan; He, Ping; Liu, Ning

2014-06-01

To evaluate the clinical efficacy and safety of tissue-selecting therapy (TST) in treatment of mixed hemorrhoids. A single-blind randomized study was carried out. A total of 120 patients with mixed hemorrhoids from January to December 2012 were prospectively enrolled in the study and equally divided into two groups, TST group and procedure for prolapse and hemorrhoids(PPH) group. Surgical data, efficacy and postoperative complications were compared between the two groups. As compared to PPH group, patients in TST group had shorter operation time [(15.9±5.18) min vs. (22.6±7.1) min, P<0.05], lower scores of rectal urgency (0.5±0.2 vs. 1.5±1.4, P<0.05), and shorter hospital stay [(11.2±3.7) d vs. (14.8±3.7) d, P<0.05]. No anastomotic stricture case was found in TST group, while 11 cases(18.3%) developed anastomotic stricture in PPH group. There were no significant differences in effective rate and pain score of first defecation between the two groups. TST is reliable and safe for mixed hemorrhoids with the advantage of simple, rapid recovery and less complications.

Comparison of Two brands of Methylphenidate (Stimdate(®) vs. Ritalin(®)) in Children and Adolescents with Attention Deficit Hyperactivity Disorder: A Double-Blind, Randomized Clinical Trial.

PubMed

Khodadust, Naser; Jalali, Amir-Hossein; Ahmadzad-Asl, Masoud; Khademolreza, Noushin; Shirazi, Elham

2012-01-01

To compare the effectiveness and safety of the methylphenidate produced in Iran (Stimdate®) with its original brand (Ritalin®) in children with Attention deficit hyperactivity disorder (ADHD). In this double-blinded randomized clinical trial, 30 patients with ADHD who were 6 to 16 years old, were divided into two groups: 15 in Stimdate® and 15 in Ritalin® group. The two groups were compared for side effects profile, Conner's Parent's Rating Scale-Persion version (CPRS-R), Child Symptom Inventory-4 (CSI-4), Clinical Global Impressions (CGI), and Children's Global Assessment Scale (CGAS), at baseline and at the 4(th) and 6(th) weeks. The subjects showed significant decreases in the CPRS-Rand CSI-4 scores and significant increase of CGAS scores during the follow-up, but there were no significant difference between Stimdate® and Ritalin® group, regarding the pattern of changes observed. The mean therapeutic dose and the number of side effects were not significantly different between the two studied groups. Both Stimdate® and Ritalin® had comparable clinical efficacy and safety in children with ADHD.

Acupuncture in the management of chronic low back pain: a blinded randomized controlled trial.

PubMed

Kerr, Daniel P; Walsh, Deirdre M; Baxter, David

2003-01-01

To assess the efficacy of acupuncture in the treatment of chronic low back pain. Patients (n = 60) with chronic low back pain were recruited and randomly allocated to either Acupuncture therapy or Placebo transcutaneous electrical nerve stimulation (TENS) groups. Patients were treated weekly for 6 weeks, and blinded assessments were carried out pre- and post-treatment using the McGill Pain Questionnaire (MPQ) and visual analog scales (VAS) for pain, the Short-form 36 quality-of-life questionnaire, and a simple range of motion measurement. A total of 46 patients completed the trial and were followed up at 6 months. Analysis of results using t tests showed that in both groups there were significant pre-post improvements for all scores, except for MPQ scores in the Placebo-TENS group. There was no significant difference between the 2 groups for any of the outcome measures at the end of treatment. Results from the 6-month follow-up would suggest that the response was better in the acupuncture group. Further research is necessary to fully assess the efficacy of this treatment in combating chronic low back pain using larger sample sizes or alternative control groups.

Celecoxib for the treatment of mild-to-moderate depression due to acute brucellosis: a double-blind, placebo-controlled, randomized trial.

PubMed

Jafari, S; Ashrafizadeh, S-G; Zeinoddini, A; Rasoulinejad, M; Entezari, P; Seddighi, S; Akhondzadeh, S

2015-08-01

Depression is a debilitating complication of brucellosis and how best to treat this is a matter of debate. Inflammatory processes are involved in the pathogenesis of both brucellosis and depression. Therefore, we hypothesized that celecoxib could be beneficial for the treatment of depression due to brucellosis. Forty outpatients with depression due to brucellosis with a Hamilton Depression Rating Scale score (HDRS) <19 participated in a randomized, double-blind, placebo-controlled trial and underwent 8 weeks of treatment with either celecoxib (200 mg bid) or placebo as an adjunctive to antibiotic therapy. Patients were evaluated using HDRS at baseline and weeks 4 and 8. Repeated-measures analysis demonstrated significant effect for time × treatment interaction on the HDRS score [F (1·43, 57·41) = 37·22, P < 0·001]. Significantly greater response to treatment occurred in the celecoxib group than in the placebo group at the study end [10 patients (50%) vs. no patient (0%), respectively, P < 0·001]. No serious adverse event was observed. Celecoxib is a safe and effective treatment for depression due to brucellosis when compared with placebo. © 2015 John Wiley & Sons Ltd.

Decreased low back pain intensity and differential gene expression following Calmare®: results from a double-blinded randomized sham-controlled study.

PubMed

Starkweather, Angela R; Coyne, Patrick; Lyon, Debra E; Elswick, R K; An, Kyungeh; Sturgill, Jamie

2015-02-01

In this double-blinded, randomized controlled trial we evaluated the effects of Calmare®, a non-invasive neurocutaneous electrical pain intervention, on lower back pain intensity as measured by the "worst" pain score and on pain interference using the Brief Pain Inventory-Short Form, on measures of pain sensitivity assessed by quantitative sensory testing, and on mRNA expression of pain sensitivity genes. Thirty participants were randomized to receive up to 10 sessions of Calmare® treatment (n = 15) or a sham treatment (n = 15) using the same device at a non-therapeutic threshold. At 3 weeks after conclusion of treatment, compared with the sham group, the Calmare® group reported a significant decrease in the "worst" pain and interference scores. There were also significant differences in pain sensitivity and differential mRNA expression of 17 pain genes, suggesting that Calmare® can be effective in reducing pain intensity and interference in individuals with persistent low back pain by altering the mechanisms of enhanced pain sensitivity. Further study of long-term pain outcomes, particularly functional status, analgesic use and health care utilization, is warranted. © 2015 Wiley Periodicals, Inc.

Comparison of chocolate to cacao-free white chocolate in Parkinson's disease: a single-dose, investigator-blinded, placebo-controlled, crossover trial.

PubMed

Wolz, Martin; Schleiffer, Christine; Klingelhöfer, Lisa; Schneider, Christine; Proft, Florian; Schwanebeck, Uta; Reichmann, Heinz; Riederer, Peter; Storch, Alexander

2012-11-01

A previous questionnaire study suggests an increased chocolate consumption in Parkinson's disease (PD). The cacao ingredient contains caffeine analogues and biogenic amines, such as β-phenylethylamine, with assumed antiparkinsonian effects. We thus tested the effects of 200 g of chocolate containing 80 % of cacao on UPDRS motor score after 1 and 3 h in 26 subjects with moderate non-fluctuating PD in a mono-center, single-dose, investigator-blinded crossover study using cacao-free white chocolate as placebo comparator. At 1 h after chocolate intake, mean UPDRS motor scores were mildly decreased compared to baseline in both treatments with significant results only for dark chocolate [-1.3 (95 % CI 0.18-2.52, RMANOVA F = 4.783, p = 0.013¸ Bonferroni p = 0.021 for 1 h values)]. A 2 × 2-cross-over analysis revealed no significant differences between both treatments [-0.54 ± 0.47 (95 % CI -1.50 to 0.42), p = 0.258]. Similar results were obtained at 3 h after intake. β-phenylethylamine blood levels were unaltered. Together, chocolate did not show significant improvement over white cacao-free chocolate in PD motor function.

Comparison of lidocaine spray and paracervical block application for pain relief during first-trimester surgical abortion: A randomised, double-blind, placebo-controlled trial.

PubMed

Aksoy, Huseyin; Aksoy, Ulku; Ozyurt, Sezin; Ozoglu, Nil; Acmaz, Gokhan; Aydın, Turgut; İdem Karadağ, Özge; Tayyar, Ahter Tanay

2016-07-01

Surgical abortion is one of the most frequently performed gynaecological procedures and its associated pain has always been a problem in gynaecology. Here we studied the analgesic efficacy of lidocaine spray and paracervical block (PCB) in patients undergoing first-trimester surgical abortion. A randomised double-blind placebo-controlled study was conducted on 108 women requesting pregnancy termination. The subjects were randomly assigned into four groups: Group 1 (PCB plus lidocaine spray) (n=27), Group 2 (PCB) (n=27), Group 3 (lidocaine spray) (n=27) and Group 4 (placebo) (n=27). Intra-procedural and post-procedural pain scores were measured with a standard visual analogue scale (VAS). The median VAS scores during procedure in placebo, lidocaine spray, PCB plus lidocaine spray and PCB groups were 8 (7-9), 5 (4-8), 4 (3-4) and 5 (3-5), respectively. The most effective method of pain relief during first-trimester abortion can be achieved through a combined use of PCB plus lidocaine spray. Therefore, lidocaine spray is a non-invasive complementary anaesthetic method versus traditional PCB for first-trimester surgical abortion.

Reproducibility of dynamically represented acoustic lung images from healthy individuals

PubMed Central

Maher, T M; Gat, M; Allen, D; Devaraj, A; Wells, A U; Geddes, D M

2008-01-01

Background and aim: Acoustic lung imaging offers a unique method for visualising the lung. This study was designed to demonstrate reproducibility of acoustic lung images recorded from healthy individuals at different time points and to assess intra- and inter-rater agreement in the assessment of dynamically represented acoustic lung images. Methods: Recordings from 29 healthy volunteers were made on three separate occasions using vibration response imaging. Reproducibility was measured using quantitative, computerised assessment of vibration energy. Dynamically represented acoustic lung images were scored by six blinded raters. Results: Quantitative measurement of acoustic recordings was highly reproducible with an intraclass correlation score of 0.86 (very good agreement). Intraclass correlations for inter-rater agreement and reproducibility were 0.61 (good agreement) and 0.86 (very good agreement), respectively. There was no significant difference found between the six raters at any time point. Raters ranged from 88% to 95% in their ability to identically evaluate the different features of the same image presented to them blinded on two separate occasions. Conclusion: Acoustic lung imaging is reproducible in healthy individuals. Graphic representation of lung images can be interpreted with a high degree of accuracy by the same and by different reviewers. PMID:18024534

Efficacy of Trimetazidine Dihydrochloride for Relieving Chronic Tinnitus: A Randomized Double-Blind Study

PubMed Central

Kumral, Tolgar Lütfi; Yıldırım, Güven; Berkiten, Güler; Saltürk, Ziya; Ataç, Enes; Atar, Yavuz; Uyar, Yavuz

2016-01-01

Objectives. To evaluate the efficacy of trimetazidine dihydrochloride as a treatment for chronic tinnitus. Methods. A total of 97 chronic tinnitus patients were evaluated in this randomized, prospective, double-blind, placebo-controlled trial. After assessing for eligibility, 82 patients were randomly assigned into placebo or trimetazidine groups according to the medication. The trimetazidine group received 20×3 mg/day per oral trimetazidine dihydrochloride and the placebo group received 20×3 mg/day per oral placebo for 3 months. Tinnitus handicap inventory (THI), visual analogue scale (VAS) questionnaires and audiometric results were used to determine the effectiveness of trimetazidine treatment. Results. The study group comprised 82 tinnitus subjects, 42 (51%) of whom received trimetazidine dihydrochloride and 40 (49%) who received placebo. There was no significant difference between placebo and trimetazidine groups in THI grade and VAS (both pre- and posttreatment scores) (P>0.05) and no significant improvement was observed in subjective loudness score in either group (P>0.05). Additionally there was no significant difference between groups in pre- and posttreatment pure tone hearing thresholds at all measured frequencies (P>0.05). Conclusion. Trimetazidine dihydrochloride therapy was ineffective for relieving chronic tinnitus. PMID:27230273

A Completely Blind Video Integrity Oracle.

PubMed

Mittal, Anish; Saad, Michele A; Bovik, Alan C

2016-01-01

Considerable progress has been made toward developing still picture perceptual quality analyzers that do not require any reference picture and that are not trained on human opinion scores of distorted images. However, there do not yet exist any such completely blind video quality assessment (VQA) models. Here, we attempt to bridge this gap by developing a new VQA model called the video intrinsic integrity and distortion evaluation oracle (VIIDEO). The new model does not require the use of any additional information other than the video being quality evaluated. VIIDEO embodies models of intrinsic statistical regularities that are observed in natural vidoes, which are used to quantify disturbances introduced due to distortions. An algorithm derived from the VIIDEO model is thereby able to predict the quality of distorted videos without any external knowledge about the pristine source, anticipated distortions, or human judgments of video quality. Even with such a paucity of information, we are able to show that the VIIDEO algorithm performs much better than the legacy full reference quality measure MSE on the LIVE VQA database and delivers performance comparable with a leading human judgment trained blind VQA model. We believe that the VIIDEO algorithm is a significant step toward making real-time monitoring of completely blind video quality possible.

Subjective effects of Lepidium meyenii (Maca) extract on well-being and sexual performances in patients with mild erectile dysfunction: a randomised, double-blind clinical trial.

PubMed

Zenico, T; Cicero, A F G; Valmorri, L; Mercuriali, M; Bercovich, E

2009-04-01

Lepidium meyenii (Maca) is a cultivated root belonging to the brassica family used in the Andean region for its supposed aphrodisiac properties. We carried out a double-blind clinical trial on 50 Caucasian men affected by mild erectile dysfunction (ED), randomised to treatment with Maca dry extract, 2400 mg, or placebo. The treatment effect on ED and subjective well-being was tested administrating before and after 12 weeks the International Index of Erectile Function (IIEF-5) and the Satisfaction Profile (SAT-P). After 12 weeks of treatment, both Maca- and placebo-treated patients experienced a significant increase in IIEF-5 score (P < 0.05 for both). However, patients taking Maca experienced a more significant increase than those taking placebo (1.6 +/- 1.1 versus 0.5 +/- 0.6, P < 0.001). Both Maca- and placebo-treated subjects experienced a significant improvement in psychological performance-related SAT-P score, but the Maca group higher than that of placebo group (+9 +/- 6 versus +6 +/- 5, P < 0.05). However, only Maca-treated patients experienced a significant improvement in physical and social performance-related SAT-P score compared with the baseline (+7 +/- 6 and +7 +/- 6, both P < 0.05). In conclusion, our data support a small but significant effect of Maca supplementation on subjective perception of general and sexual well-being in adult patients with mild ED.

Does hydroxyapatite coating enhance ingrowth and improve longevity of a Zweymuller type stem? A double-blinded randomised RSA trial.

PubMed

Hoornenborg, Daniel; Sierevelt, Inger N; Spuijbroek, Joost A; Cheung, John; van der Vis, Harm M; Beimers, Lijkele; Haverkamp, Daniel

2017-09-11

An ongoing discussion is whether using a hydroxyapatite coating enhances the ingrowth and longevity of a femoral stem in total hip arthroplasty. The best way to predict speed of ingrowth and long-term outcome is by evaluating micromotion by radiostereometric analysis. To study the effect of hydroxyapatite (HA) coating on the migration of the SL-PLUS hip stem, we performed a prospective double blind randomised controlled trial comparing the early migration of the hydroxyapatite (HA)-coated SL-PLUS stem compared to the Standard (non-coated) SL-PLUS stem. 51 patients were randomly assigned to receive either an uncoated or a HA-coated femoral component during total hip replacement. RSA images were obtained direct postoperatively and at 6 weeks, 12 weeks, 6 months, 12 months and 24 months. HOOS scores were obtained preoperative and at final follow-up. RSA evaluation demonstrated significant migration up to 3 months postoperatively in both groups. After initial setting no significant migration was observed. There was no significant difference in migration between the HA-coated group and the uncoated group.Both Harris Hip Score (HHS) and HOOS domain scores (pain and ADL) significantly improved compared to baseline at 24 months after surgery in both treatment groups (p<0.001 for all comparisons). Improvement did not differ significantly between the 2 groups. At 2 years follow-up, the HA-coated and uncoated Zweymuller type, distal fitting stem do not show different migration patterns.

Tolerance of low-frequency ultrasound sonophoresis: a double-blind randomized study on humans.

PubMed

Maruani, Annabel; Vierron, Emilie; Machet, Laurent; Giraudeau, Bruno; Halimi, Jean-Michel; Boucaud, Alain

2012-05-01

Sonophoresis [low-frequency ultrasound (US)] has been used in animals and in vitro to investigate enhanced percutaneous absorption of drugs. No study focused on its clinical human tolerance has been published as yet. We aimed to assess the bioeffects of low-frequency US in vivo on human skin in a double-blind randomized-controlled study. We applied pulse-mode US at 36 kHz for 5 min in a step procedure of increasing dosage, from 1.57 to 3.50 W/cm(2), and placebo. The primary outcome was toxic effects of the procedure, defined as a pain score >40 on a 0-100 mm visual analogue scale or necrosis. Erythema (scored from 0 to 3 in severity) was also evaluated. The secondary outcomes were measurements of skin thickness by high-resolution skin imaging, of skin capacitance and temperature. We included 34 healthy volunteers. We found no pain score >38 and no skin necrosis with either US or placebo. Erythema was systematically observed immediately after US application, but after 1 day, we observed three cases in the knee group. The most frequent adverse effect was tinnitus. We observed no marked increase in temperature or cutaneous thickness after US or placebo. Cutaneous capacitance increased immediately after both applications. Such data demonstrating good tolerance of sonophoresis can be useful before the initiation of a clinical trial of the therapeutic use of low-frequency sonophoresis in humans. © 2011 John Wiley & Sons A/S.

Effect of terazosin on lower urinary tract symptoms and pain due to double-J stent: a double-blind placebo-controlled randomized clinical trial.

PubMed

Mokhtari, Gholamreza; Shakiba, Maryam; Ghodsi, Sara; Farzan, Alireza; Heidari Nejad, Sayeh; Esmaeili, Samaneh

2011-01-01

We evaluated the effect of terazosin in the improvement of lower urinary tract symptoms and flank pain in patients with internal ureteral stents. In this double-blind randomized clinical trial, 73 patients with unilateral ureteral stone and hydroureteronephrosis who underwent insertion of an internal ureteral stent after transureteral lithotripsy (TUL) were randomized into two groups. 37 patients received terazosin 2 mg (once nightly) for 4 weeks and 36 patients received placebo for the same time duration. After 4 weeks, all patients were asked about the incidence of frequency, nocturia and urgency by an International Prostate Symptom Score (IPSS) questionnaire, flank pain and pain during urination by a visual analog scale (VAS) score, and hematuria. The mean VAS score was 2.21 in the terazosin group compared with 4.93 in the control group (p < 0.001). Nearly all the patients in the placebo group reported flank pain during urination but this was only reported in 54.5% of the patients in the terazosin group (p < 0.001). All criteria measured by the IPSS in the terazosin group were significantly lower than those in the placebo group (p = 0.0001). Administration of terazosin for patients with an internal ureteral stent relieved some stent-related symptoms such as flank pain, pain during voiding, frequency, nocturia and urgency, but had no effect on hematuria. Copyright © 2011 S. Karger AG, Basel.

A multicenter, double-blind, placebo-controlled study of sildenafil citrate in Canadian men with erectile dysfunction and untreated symptoms of depression, in the absence of major depressive disorder.

PubMed

Kennedy, Sidney H; Dugré, Hélène; Defoy, Isabelle

2011-05-01

Depression and erectile dysfunction (ED) often co-occur. Phosphodiesterase type 5 inhibitors are effective in men with ED and untreated depression, or ED secondary to antidepressants. This study evaluated sildenafil treatment in Canadian men with clinically diagnosed ED (Sexual Health Inventory for Men score ≤ 21) and mild-to-moderate untreated depressive symptoms [Beck Depression Inventory II (BDI-II) score 14-28], but excluding major depressive disorder. Pretreatment screening using the Sexual Health Inventory for Men and BDI-II showed that men with ED were more likely to have depression than men without ED, and ED severity was a predictor of depression (P=0.0226). Two hundred and two men were randomized to 6 weeks of double-blind treatment with placebo (n=98) or sildenafil (n=104), initial dose of 50 mg, adjustable to 25 or 100 mg. The men were evaluated on all domains of the International Index of Erectile Function and the Sex Effects Questionnaire, Global Efficacy Questions, and Event-log data. Compared with placebo, patients treated with sildenafil had significantly greater changes from baseline in BDI-II scores (P<0.001). All International Index of Erectile Function domains and the Sex Effects Questionnaire components were also significantly improved in sildenafil group (P<0.01). The most common adverse events included headache, dyspepsia, vasodilatation, and respiratory tract infections and were generally mild in intensity. 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins.

Comparative Evaluation of Effect of Nano-hydroxyapatite and 8% Arginine Containing Toothpastes in Managing Dentin Hypersensitivity: Double Blind Randomized Clinical Trial.

PubMed

Anand, Suresh; Rejula, Fathima; Sam, Joseph V G; Christaline, Ramakrishnan; Nair, Mali G; Dinakaran, Shiji

This double blind randomized clinical trial was conducted with the purpose of evaluating the effects of Nano-hydroxyapatite toothpaste as compared to 8% Arginine containing toothpaste in the management of Dentin hypersensitivity (DH). Patients (30 in each group) suffering from DH and eliciting a VAS score higher than 2 in air blast and tactile test were randomly allocated (block randomization) into either a group 1 (arginine toothpaste) or group 2 (nHA toothpaste). The primary outcome evaluated was the reduction of DH as measured by the electrical stimulus reading on the digital pulp tester. Current required for eliciting a VAS score of 2 was recorded before application of dentifrice. 1 cm of toothpaste was then expressed on the tooth surface for two minutes in each group and rinsed off. The electrical stimulus required to elicit a VAS score of 2 was recorded after 5 minutes, 1 week and 4 weeks. The desensitizing paste containing arginine provided a statistically significant reduction in DH and so did the paste containing nHA. Mean increase in amperage value (reduction in DH) was higher for nHA based than the arginine containing dentifrice. This difference was not statistically significant showing that both toothpastes are equally effective. The findings of the present study encourage the use of Nano-hydroxyapatite and arginine containing dentifrice as an effective desensitizing agent providing relief from symptoms 5 minutes after application and after 1 and 4 weeks.

Exploratory double-blind, parallel-group, placebo-controlled extension study of edaravone (MCI-186) in amyotrophic lateral sclerosis.

PubMed

2017-10-01

Following the first phase III study of edaravone for amyotrophic lateral sclerosis (ALS), this extension study was performed to evaluate longer-term efficacy and safety. Patients given edaravone in the first 24-week phase III study (Cycles 1-6) were randomised to edaravone (E-E) or placebo (E-P) in the subsequent 24-week double-blind period (Cycles 7-12). Patients given placebo in phase III were switched to edaravone (P-E). Subsequently, all patients received edaravone for 12 weeks (Cycles 13-15). Efficacy endpoints included revised ALS Functional Rating Scale (ALSFRS-R) score. Analysis populations were the full analysis set (FAS) and the efficacy-expected subpopulation (EESP) defined by post-hoc analysis of the first phase III study. The least-squares mean and standard error of the intergroup difference (E-E vs. E-P) of change in the ALSFRS-R score from Cycles 7-12 was 1.16 ± 0.93 (p = 0.2176) in the FAS, and 1.85 ± 1.14 (p = 0.1127) in the EESP. The ALSFRS-R score changed almost linearly in the E-E group throughout Cycles 1-15 (60 weeks). The incidence of serious adverse events associated with ALS progression was higher in E-E than in E-P. Edaravone might have potential efficacy for up to 15 cycles when used to treat patients in the EESP with careful safety monitoring.

Short-term effects of highly-bioavailable curcumin for treating knee osteoarthritis: a randomized, double-blind, placebo-controlled prospective study.

PubMed

Nakagawa, Yasuaki; Mukai, Shogo; Yamada, Shigeru; Matsuoka, Masayuki; Tarumi, Eri; Hashimoto, Tadashi; Tamura, Chieko; Imaizumi, Atsushi; Nishihira, Jun; Nakamura, Takashi

2014-11-01

We previously developed a surface-controlled water-dispersible form of curcumin and named it Theracurmin(®) (Theracurmin; Theravalues, Tokyo, Japan). The area under the blood concentration-time curve of Theracurmin in humans was 27-fold higher than that of curcumin powder. We determined the clinical effects of orally administered Theracurmin in patients with knee osteoarthritis during 8 weeks of treatment. Fifty patients with knee osteoarthritis of Kellgren-Lawrence grade II or III and who were aged more than 40 years were enrolled in this randomized, double-blind, placebo-controlled, prospective clinical study. Placebo or Theracurmin containing 180 mg/day of curcumin was administered orally every day for 8 weeks. To monitor adverse events, blood biochemistry analyses were performed before and after 8 weeks of each intervention. The patients' knee symptoms were evaluated at 0, 2, 4, 6, and 8 weeks by the Japanese Knee Osteoarthritis Measure, the knee pain visual analog scale (VAS), the knee scoring system of the Japanese Orthopedic Association, and the need for nonsteroidal anti-inflammatory drugs. At 8 weeks after treatment initiation, knee pain VAS scores were significantly lower in the Theracurmin group than in the placebo group, except in the patients with initial VAS scores of 0.15 or less. Theracurmin lowered the celecoxib dependence significantly more than placebo. No major side effects were observed with Theracurmin treatment. Theracurmin shows modest potential for the treatment of human knee osteoarthritis.

Effect of Oral Silymarin Administration on Prevention of Radiotherapy Induced Mucositis: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial.

PubMed

Elyasi, Sepideh; Hosseini, Sare; Niazi Moghadam, Mohammad Reza; Aledavood, Seyed Amir; Karimi, Gholamreza

2016-11-01

Mucositis is a frequent severe complication of radiation therapy in patient with head and neck cancer. Silymarin is a polyphenolic flavonoid extracted from the milk thistle that exhibits strong antioxidant and antiinflammatory activities. In this study, we evaluate silymarin efficacy in prevention of radiotherapy induced mucositis in patients with head and neck cancer, as the first human study. During this pilot, randomized, double-blinded, placebo-controlled clinical trial, the effect of oral silymarin 420 mg daily in three divided doses starting at the first day of radiotherapy for 6 weeks, on oral mucositis occurrence was assessed. Twenty-seven patients fulfilled the inclusion criteria assigned to the silymarin or placebo group. World Health Organization and National Cancer Institute-Common Terminology Criteria oral mucositis grading scale scores were recorded at baseline and weekly during these 6 weeks. The median World Health Organization and National Cancer Institute Common Terminology Criteria scores were significantly lower in silymarin group at the end of the first to sixth week (p < 0.05). The scores increased significantly in both placebo and silymarin groups during radiotherapy, but there was a delay for mucositis development and progression in silymarin group. Prophylactic administration of conventional form of silymarin tablets could significantly reduce the severity of radiotherapy induced mucositis and delay its occurrence in patients with head and neck cancer. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Altering Hirsutism Through Ovulation Induction in Women With Polycystic Ovary Syndrome

PubMed Central

Roth, Lauren W.; Huang, Hao; Legro, Richard S.; Diamond, Michael P.; Coutifaris, Christos; Carson, Sandra A.; Steinkampf, Michael P.; Carr, Bruce R.; McGovern, Peter G.; Cataldo, Nicholas A.; Gosman, Gabriella G.; Nestler, John E.; Myers, Evan R.; Zhang, Heping; Schlaff, William D.

2012-01-01

Objective Many women with polycystic ovary syndrome (PCOS) experience infertility and hirsutism and often seek treatment for both concurrently. We investigated whether women who ovulate in response to treatment with clomiphene citrate), metformin, or both would have greater improvement in hirsutism compared to those who did not ovulate. Methods This is a secondary analysis evaluating the change in Ferriman-Gallwey score for the hirsute women (n = 505, 80.7%) from the Pregnancy in Polycystic Ovary Syndrome 1 study. This was a prospective, randomized, doubled-blind trial of 626 women with PCOS and infertility recruited from 12 university sites. They were treated with clomiphene citrate, metformin, or both (combination) for up to six cycles, and hirsutism evaluators were blinded to group assignment. Results There was a significant decrease in the Ferriman-Gallwey score between baseline and completion of the study in each of the three individual groups (clomiphene citrate, p=0.024; metformin, p=0.005; combination, p<0.001). There was no significant difference in the degree to which the hirsutism score changed when comparing the three groups (p=0.44). The change in hirsutism was not associated with the duration of treatment or with the presence or absence of ovulation. Conclusions In infertile hirsute women with PCOS, treatment with clomiphene citrate, metformin, or both for up to 6 cycles does not alter hirsutism. Clinical Trial Registration ClinicalTrials.gov, www.clinicaltrials.gov, NCT00068861. PMID:22617579

Pulpal response following photo-biomodulation with a 904-nm diode laser: a double-blind clinical study.

PubMed

Liang, Ryan; George, Roy; Walsh, Laurence J

2016-12-01

The aim of this study was to evaluate pulpal responses in healthy human teeth to photo-biomodulation therapy (PBMT) with 904-nm GaAs diode laser. The study followed a double-blind split mouth design, with a randomly selected maxillary first premolar acting as a sham-irradiated control tooth, and the contralateral tooth receiving active laser treatment. Two coded but otherwise identical laser probes (Irradia™, SpectraMedics Ltd., NC, USA) were used to deliver the sham (placebo) and laser radiation, with both the operator and patient unaware of each probe's identity. The selection of teeth for sham or laser irradiation was randomised for each treatment. Pulpal responses were assessed using electric pulp testing (EPT), 2 min prior to exposure, and immediately after laser irradiation (60 s, 30 mW average power, 25 Hz pulse frequency, 3.6 J/cm 2 ). Treatment effects were analysed using the Wilcoxon-signed rank test. A total of 30 participants provided written informed consent. Majority of the participants (66.7 %) demonstrated an analgesic effect following PBMT (elevated EPT scores); however, nine participants (30 %) reported the lower EPT scores than the control. Both the treatment effects (stimulation and analgesia) were significant compared to the placebo. In most individuals, PBMT of healthy teeth with a 904-nm GaAs diode laser can induce analgesia, as witnessed by elevated EPT scores. A converse effect can occur in a minority of subjects.

Study of active controlled monotherapy used for rheumatoid arthritis, an IL-6 inhibitor (SAMURAI): evidence of clinical and radiographic benefit from an x ray reader-blinded randomised controlled trial of tocilizumab.

PubMed

Nishimoto, Norihiro; Hashimoto, Jun; Miyasaka, Nobuyuki; Yamamoto, Kazuhiko; Kawai, Shinichi; Takeuchi, Tsutomu; Murata, Norikazu; van der Heijde, Désirée; Kishimoto, Tadamitsu

2007-09-01

To evaluate the ability of tocilizumab (a humanised anti-IL-6 receptor antibody) monotherapy to inhibit progression of structural joint damage in patients with RA. In a multi-centre, x ray reader-blinded, randomised, controlled trial, 306 patients with active RA of <5 years' duration were allocated to receive either tocilizumab monotherapy at 8 mg/kg intravenously every 4 weeks or conventional disease-modifying antirheumatic drugs (DMARDs) for 52 weeks. Radiographs of hands and forefeet were scored by the van der Heijde modified Sharp method. Patients had a mean disease duration of 2.3 years and a disease activity score in 28 joints of 6.5 at baseline. Mean total modified Sharp score (TSS) was 29.4, which was very high despite the relatively short disease duration. At week 52, the tocilizumab group showed statistically significantly less radiographic change in TSS (mean 2.3; 95% CI 1.5 to 3.2) than the DMARD group (mean 6.1; 95% CI 4.2 to 8.0; p<0.01). Tocilizumab monotherapy also improved signs and symptoms. The overall incidences of AEs were 89% and 82% (serious AEs: 18% and 13%; serious infections: 7.6% and 4.1%) in the tocilizumab and DMARD groups, respectively. Tocilizumab monotherapy was generally well tolerated and provided radiographic benefit in patients with RA.

Depressive symptoms in patients with subclinical hypothyroidism--the effect of treatment with levothyroxine: a double-blind randomized clinical trial.

PubMed

Najafi, Laily; Malek, Mojtaba; Hadian, Ali; Ebrahim Valojerdi, Ameneh; Khamseh, Mohammad E; Aghili, Rokhsareh

2015-01-01

Despite the increasing evidence for relationships between thyroid dysfunction and neuropsychiatric alterations, the effect of treatment of thyroid disease on various clinical psychiatric outcomes is controversial. The purpose of this study was to investigate the effect of levothyroxine treatment on depressive symptoms in subjects with subclinical hypothyroidism. A randomized double-blind placebo-controlled clinical trial was performed. Sixty subjects (51 females and 9 males) with subclinical hypothyroidism were enrolled. Beck Depression Inventory was completed for all participants at the beginning of the study and 12 weeks after enrollment. The intervention and control groups received levothyroxine and placebo, respectively, for 12 weeks. There were no statistical differences in the total depression score and its subscales between the two groups at the beginning of the study. The Beck Depression Inventory score decreased from 16.79 ± 13.25 to 12.37 ± 10.01 (p value = 0.04) in the intervention group. The change in score was not significant for the control group (13.77 ± 11.71 to 11.86 ± 10.71; p value= 0.16). The affective subscale of Beck Depression Inventory did not change after 12 weeks of treatment with levothyroxine, while somatic subscale remarkably improved in the intervention group (p value = 0.02). This study showed the efficacy of treatment of subclinical hypothyroidism in people with levothyroxine in relation to depressive symptoms.

The Influence of Peer Reviewer Expertise on the Evaluation of Research Funding Applications

PubMed Central

Sullivan, Joanne H.; Glisson, Scott R.

2016-01-01

Although the scientific peer review process is crucial to distributing research investments, little has been reported about the decision-making processes used by reviewers. One key attribute likely to be important for decision-making is reviewer expertise. Recent data from an experimental blinded review utilizing a direct measure of expertise has found that closer intellectual distances between applicant and reviewer lead to harsher evaluations, possibly suggesting that information is differentially sampled across subject-matter expertise levels and across information type (e.g. strengths or weaknesses). However, social and professional networks have been suggested to play a role in reviewer scoring. In an effort to test whether this result can be replicated in a real-world unblinded study utilizing self-assessed reviewer expertise, we conducted a retrospective multi-level regression analysis of 1,450 individual unblinded evaluations of 725 biomedical research funding applications by 1,044 reviewers. Despite the large variability in the scoring data, the results are largely confirmatory of work from blinded reviews, by which a linear relationship between reviewer expertise and their evaluations was observed—reviewers with higher levels of self-assessed expertise tended to be harsher in their evaluations. However, we also found that reviewer and applicant seniority could influence this relationship, suggesting social networks could have subtle influences on reviewer scoring. Overall, these results highlight the need to explore how reviewers utilize their expertise to gather and weight information from the application in making their evaluations. PMID:27768760

The healing effects of a topical phytogenic ointment on insect bite hypersensitivity lesions in horses.

PubMed

van den Boom, R; Kempenaars, M; van Oldruitenborgh-Oosterbaan, M M Sloet

2011-01-01

Insect bite hypersensitivity (IBH) is the most common cause of pruritus in horses and is a serious welfare issue for affected animals. In this study, the effect of a topical phytogenic ointment on the healing of cutaneous lesions was investigated in a double-blind trial involving 26 horses with I B H. The number of lesions and their total surface area were recorded on days 0, 7, and 21 in horses treated for 3 weeks with either verum or placebo ointment. After unblinding of treatment assignment, the horses that had been treated with the placebo ointment received the verum preparation for an additional 3 weeks and the number of lesions and their total surface area were again recorded. This part of the study was not blinded. The number of lesions and the total surface area decreased in both treatment groups (no significant difference). Owners also scored the degree of discomfort suffered by their horses as a result of IBH lesions, and at the end of the 3-week period this score was significantly lower in the verum than in the placebo group (P = 0.04). When placebo-treated horses subsequently received the verum ointment, their wound severity score also decreased significantly (P < 0.01). Daily application of an ointment (verum or placebo) does not cure IBH, but use of the phytogenic ointment led to a decrease in the owner-assessed discomfort suffered by horses.

Exploratory double-blind, parallel-group, placebo-controlled study of edaravone (MCI-186) in amyotrophic lateral sclerosis (Japan ALS severity classification: Grade 3, requiring assistance for eating, excretion or ambulation).

PubMed

2017-10-01

Our objective was to explore the efficacy and safety of edaravone in amyotrophic lateral sclerosis (ALS) patients with a Japan ALS severity classification of Grade 3. In a 24-week, double-blind, randomized study, 25 patients who met all of the following criteria were enrolled: Japan ALS severity classification Grade 3; definite, probable, or probable-laboratory supported ALS (El Escorial/revised Airlie House); forced vital capacity (%FVC) ≥60%; duration of disease ≤3 years at consent; and change in the revised ALS functional rating scale (ALSFRS-R) score of -1 to -4 points during the 12-week pre-observation period. Patients received edaravone (n = 13) or placebo (n = 12) for six cycles. The efficacy outcome was change in the ALSFRS-R score. The least-squares mean change in the ALSFRS-R score ± standard error during the 24-week treatment was -6.52 ± 1.78 in the edaravone group and -6.00 ± 1.83 in the placebo group; the difference of -0.52 ± 2.46 was not statistically significant (p = 0.835). Incidence of adverse events was 92.3% (12/13) in the edaravone group and 100.0% (12/12) in the placebo group. There was no intergroup difference in the changes in the ALSFRS-R score. The incidences of adverse events were similar in the two groups.

Treatment of Plantar Fasciitis With Botulinum Toxin.

PubMed

Ahmad, Jamal; Ahmad, Stacy H; Jones, Kennis

2017-01-01

This study examined the effect of botulinum toxin upon plantar fasciitis through a randomized, controlled, and blinded trial. Between 2012 and 2015, 50 patients presented with plantar fasciitis. Twenty-five patients each randomly received an IncobotulinumtoxinA (IBTA) or saline injection of their affected foot. Pre- and postinjection function and pain were graded with the Foot and Ankle Ability Measures (FAAM) and visual analog scale (VAS), respectively. All 50 study patients who randomly received either placebo or IBTA presented at 6 and 12 months after injection. At 6 months, the mean FAAM increased from 35.9 to 40.9 of 100, and the mean pain score decreased from 8.4 to 7.9 of 10 within the placebo group. At 6 months, the mean FAAM increased from 36.3 to 73.8 of 100, and mean pain score decreased from 7.2 to 3.6 of 10 within the IBTA group. These postinjection scores were significantly better than the placebo group ( P = .01). At 12 months after injection, the IBTA group maintained significantly better function and pain than the placebo group ( P < .05). By that time, 0 (0%) and 3 (12%) patients who received IBTA and saline, respectively, underwent surgery for recalcitrant plantar fasciitis ( P < .005). Compared with placebo saline injection, using IBTA to treat plantar fasciitis resulted in significantly better improvement in foot function and pain. IBTA also lessened the need for operative treatment of plantar fasciitis. I, Randomized, double-blinded, placebo-controlled study.

Effect of stretching with and without muscle strengthening exercises for the foot and hip in patients with plantar fasciitis: A randomized controlled single-blind clinical trial.

PubMed

Kamonseki, Danilo H; Gonçalves, Geiseane A; Yi, Liu C; Júnior, Império Lombardi

2016-06-01

To compare the effect of stretching with and without muscle strengthening of the foot alone or foot and hip on pain and function in patients with plantar fasciitis. Single blind randomized controlled trial. Eighty-three patients with plantar fasciitis were allocated to one of three treatment options for an eight-week period: Foot Exercise Group (FEG - extrinsic and intrinsic foot muscles), Foot and Hip Exercise Group (FHEG - abductor and lateral rotator muscles) and Stretching Alone Exercise Group (SAEG). A visual analog scale for pain, the Foot and Ankle Outcome Score and the Star Excursion Balance Test. All evaluations were performed before treatment and after the last treatment session. Improvements were found in all groups regarding the visual analog scale, the pain, activities of daily living, sports and recreation, quality of life (p < 0.001) and other symptoms (p < 0.01) subscales of the Foot and Ankle Outcome Score as well as posterolateral movement, posteromedial movement and composite score (p < 0.001) on the Star Excursion Balance Test. No time-group interactions were found for any of the variables (p > 0.05). All three exercise protocols analyzed led to improvements at eight-week follow-up in pain, function and dynamic lower limb stability in patients with plantar fasciitis. Copyright © 2015 Elsevier Ltd. All rights reserved.

Analgesic effect of ultrasound-guided transversus abdominis plane block after total abdominal hysterectomy: a randomized, double-blind, placebo-controlled trial.

PubMed

Røjskjaer, Jesper O; Gade, Erik; Kiel, Louise B; Lind, Morten N; Pedersen, Lars M; Kristensen, Billy B; Rasmussen, Yvonne H; Foss, Nicolai B

2015-03-01

To assess the effect of bilateral ultrasound-guided transversus abdominis plane block with ropivacaine compared with placebo as part of a multimodal analgesic regimen. A randomized, double-blind, placebo-controlled trial following the CONSORT criteria. Hvidovre University Hospital. Forty-six women scheduled for total abdominal hysterectomy. Women received either ropivacaine 0.75%, 20 mL (n = 24) or 0.9% saline, 20 mL (n = 24) in the transversus abdominis plane on each side. Primary outcome was the 24-h postoperative morphine consumption. Secondary outcomes were pain scores at rest and during coughing, postoperative nausea and vomiting at 1, 2, 4, 6, 8, and 24 h, and time to first mobilization. There was no difference in the mean 24-h postoperative morphine consumption between the two groups (p = 0.733). The ropivacaine group had significantly lower median pain scores at 1 h (p = 0.008) and 2 h (p = 0.027) postoperatively at rest and at 8 h (p = 0.028) during coughing. There was no significant difference in other secondary outcomes. There was no reduction in 24-h morphine consumption when using an ultrasound-guided transversus abdominis plane block in women undergoing total abdominal hysterectomy. As part of a multimodal regimen the transversus abdominis plane block showed some effect on pain scores at rest only in the early postoperative period. © 2014 Nordic Federation of Societies of Obstetrics and Gynecology.

Randomized, double-blind, placebo-controlled trial of fluoxetine treatment for elderly patients with dysthymic disorder.

PubMed

Devanand, D P; Nobler, Mitchell S; Cheng, Jocelyn; Turret, Nancy; Pelton, Gregory H; Roose, Steven P; Sackeim, Harold A

2005-01-01

The authors compared the efficacy and side effects of fluoxetine and placebo in elderly outpatients with dysthymic disorder. Patients were randomly assigned to fluoxetine (20 mg-60 mg/day) or placebo for 12 weeks in a double-blind trial. Of 90 randomized patients, 71 completed the trial. In the intent-to-treat sample, random regression analyses of the Hamilton Rating Scale for Depression (Ham-D; 24-item) and Cornell Dysthymia Rating Scale (CDRS) scores at each visit produced significant time x treatment group interactions favoring the fluoxetine group. Analysis of percentage change in Ham-D scores yielded no effect for treatment group, but a similar analysis of percentage change in CDRS scores yielded a main effect for treatment group, favoring fluoxetine over placebo. In the intent-to-treat sample, response rates were 27.3% for fluoxetine and 19.6% for placebo. In the completer sample, response rates were 37.5% for fluoxetine and 23.1% for placebo. Fluoxetine had limited efficacy in elderly dysthymic patients. The clinical features of elderly dysthymic patients are typically distinct from those of dysthymic disorder in young adults, and the findings suggest that treatments effective for young adult dysthymic patients may not be as useful in elderly dysthymic patients. Further research is needed to identify efficacious treatments for elderly patients with dysthymic disorder, and investigative tools such as electronic/computerized brain scans and neuropsychological testing may help identify the factors that moderate antidepressant treatment response and resistance.

Efficacy of topical Aloe vera in patients with oral lichen planus: a randomized double-blind study.

PubMed

Salazar-Sánchez, N; López-Jornet, P; Camacho-Alonso, F; Sánchez-Siles, M

2010-11-01

  Different treatments have been used in application to symptomatic oral lichen planus (OLP), with variable results, perhaps caused by the refractory nature of the disease. The objective of this study was to evaluate the efficacy of the topical application of aloe vera (AV) in OLP compared with placebo. A total of 64 patients with OLP were randomized in a double-blind study to either AV (32 patients) or placebo (32 patients), at a dose of 0.4 ml (70% concentration) three times a day. A Visual Analog Scale was used for rating pain, with the application of a clinical scale for scoring the lesions, the Oral Health Impact Profile 49 (OHIP-49), and the Hospital Anxiety-Depression (HAD) scale. The patients were evaluated after 6 and 12 weeks. No statistically significant differences were recorded between both groups in relation to pain after 6 and 12 weeks. In the AV group, complete pain remission was achieved in 31.2% of the cases after 6 weeks, and in 61% after 12 weeks. In the placebo group, these percentages were 17.2% and 41.6%, respectively. There were no adverse effects in any of the groups. In relation to quality of life, significant differences were observed between the two groups in the psychological disability domain and total OHIP-49 score. The topical application of AV improves the total quality of life score in patients with OLP. © 2010 John Wiley & Sons A/S.

A Prospective, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating Meniscal Healing, Clinical Outcomes, and Safety in Patients Undergoing Meniscal Repair of Unstable, Complete Vertical Meniscal Tears (Bucket Handle) Augmented with Platelet-Rich Plasma.

PubMed

Kaminski, Rafal; Kulinski, Krzysztof; Kozar-Kaminska, Katarzyna; Wielgus, Monika; Langner, Maciej; Wasko, Marcin K; Kowalczewski, Jacek; Pomianowski, Stanislaw

2018-01-01

The present study aimed to investigate the effectiveness and safety of platelet-rich plasma (PRP) application in arthroscopic repair of complete vertical tear of meniscus located in the red-white zone. This single center, prospective, randomized, double-blind, placebo-controlled, parallel-arm study included 37 patients with complete vertical meniscus tears. Patients received an intrarepair site injection of either PRP or sterile 0.9% saline during an index arthroscopy. The primary endpoint was the rate of meniscus healing in the two groups. The secondary endpoints were changes in the International Knee Documentation Committee (IKDC) score, Knee Injury and Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and analog scale (VAS) in the two groups at 42 months. After 18 weeks, the meniscus healing rate was significantly higher in the PRP-treated group than in the control group (85% versus 47%, P = 0.048). Functional outcomes were significantly better 42 months after treatment than at baseline in both groups. The IKDC score, WOMAC, and KOOS were significantly better in the PRP-treated group than in the control group. No adverse events were reported during the study period. The findings of this study indicate that PRP augmentation in meniscus repair results in improvements in both meniscus healing and functional outcome.

A Prospective, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating Meniscal Healing, Clinical Outcomes, and Safety in Patients Undergoing Meniscal Repair of Unstable, Complete Vertical Meniscal Tears (Bucket Handle) Augmented with Platelet-Rich Plasma

PubMed Central

Kulinski, Krzysztof; Kozar-Kaminska, Katarzyna; Wielgus, Monika; Langner, Maciej; Wasko, Marcin K.; Kowalczewski, Jacek; Pomianowski, Stanislaw

2018-01-01

Objective The present study aimed to investigate the effectiveness and safety of platelet-rich plasma (PRP) application in arthroscopic repair of complete vertical tear of meniscus located in the red-white zone. Methods This single center, prospective, randomized, double-blind, placebo-controlled, parallel-arm study included 37 patients with complete vertical meniscus tears. Patients received an intrarepair site injection of either PRP or sterile 0.9% saline during an index arthroscopy. The primary endpoint was the rate of meniscus healing in the two groups. The secondary endpoints were changes in the International Knee Documentation Committee (IKDC) score, Knee Injury and Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and analog scale (VAS) in the two groups at 42 months. Results After 18 weeks, the meniscus healing rate was significantly higher in the PRP-treated group than in the control group (85% versus 47%, P = 0.048). Functional outcomes were significantly better 42 months after treatment than at baseline in both groups. The IKDC score, WOMAC, and KOOS were significantly better in the PRP-treated group than in the control group. No adverse events were reported during the study period. Conclusions The findings of this study indicate that PRP augmentation in meniscus repair results in improvements in both meniscus healing and functional outcome. PMID:29713647

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

Godfrey, Andrew T.; Collins, Benjamin S.; Gentry, Cole A.

CASL members TVA, Westinghouse, and Oak Ridge National Laboratory have successfully completed a detailed simulation of the initial startup of Watts Bar Nuclear Unit 2 (WBN2) using the advanced reactor simulation tools known as VERA. WBN2 is the first commercial power reactor to join the nation’s electrical grid in over two decades, and the modern core design and availability of data make it an excellent benchmark for CASL. Calculations were performed three months prior to the startup, and in the first blind application of VERA to a new reactor, predicted criticality and physics parameters very close to those later measuredmore » by TVA. Subsequent calculations with the latest version of VERA and using exact measurement conditions improved the results even further.« less

Apply lightweight recognition algorithms in optical music recognition

NASA Astrophysics Data System (ADS)

Pham, Viet-Khoi; Nguyen, Hai-Dang; Nguyen-Khac, Tung-Anh; Tran, Minh-Triet

2015-02-01

The problems of digitalization and transformation of musical scores into machine-readable format are necessary to be solved since they help people to enjoy music, to learn music, to conserve music sheets, and even to assist music composers. However, the results of existing methods still require improvements for higher accuracy. Therefore, the authors propose lightweight algorithms for Optical Music Recognition to help people to recognize and automatically play musical scores. In our proposal, after removing staff lines and extracting symbols, each music symbol is represented as a grid of identical M ∗ N cells, and the features are extracted and classified with multiple lightweight SVM classifiers. Through experiments, the authors find that the size of 10 ∗ 12 cells yields the highest precision value. Experimental results on the dataset consisting of 4929 music symbols taken from 18 modern music sheets in the Synthetic Score Database show that our proposed method is able to classify printed musical scores with accuracy up to 99.56%.

PepArML: A Meta-Search Peptide Identification Platform

PubMed Central

Edwards, Nathan J.

2014-01-01

The PepArML meta-search peptide identification platform provides a unified search interface to seven search engines; a robust cluster, grid, and cloud computing scheduler for large-scale searches; and an unsupervised, model-free, machine-learning-based result combiner, which selects the best peptide identification for each spectrum, estimates false-discovery rates, and outputs pepXML format identifications. The meta-search platform supports Mascot; Tandem with native, k-score, and s-score scoring; OMSSA; MyriMatch; and InsPecT with MS-GF spectral probability scores — reformatting spectral data and constructing search configurations for each search engine on the fly. The combiner selects the best peptide identification for each spectrum based on search engine results and features that model enzymatic digestion, retention time, precursor isotope clusters, mass accuracy, and proteotypic peptide properties, requiring no prior knowledge of feature utility or weighting. The PepArML meta-search peptide identification platform often identifies 2–3 times more spectra than individual search engines at 10% FDR. PMID:25663956

A blind test of nondestructive underground void detection by ground penetrating radar (GPR)

NASA Astrophysics Data System (ADS)

Lai, Wallace W. L.; Chang, Ray K. W.; Sham, Janet F. C.

2018-02-01

Blind test/experiment is widely adopted in various scientific disciplines like medicine drug testing/clinical trials/psychology, but not popular in nondestructive testing and evaluation (NDTE) nor near-surface geophysics (NSG). This paper introduces a blind test of nondestructive underground void detection in highway/pavement using ground penetrating radar (GPR). Purpose of which is to help the Highways Department (HyD) of the Hong Kong Government to evaluate the feasibility of large-scale and nationwide application, and examine the ability of appropriate service providers to carry out such works. In the past failure case of such NDTE/NSG based on lowest bid price, it is not easy to know which part(s) in SWIMS (S - service provider, i.e. people; W - work procedure; I - instrumentation; M - materials in the complex underground; S - specifications by client) fails, and how it/they fail(s). This work attempts to carry out the blind test by burying fit balls (as voids) under a site with reinforced concrete road and paving block by PolyU team A. The blind test about the void centroid, spread and cover depth was then carried out by PolyU team B without prior information given. Then with this baseline, a marking scheme, acceptance criteria and passing mark were set to test six local commercial service providers, determine their scores and evaluate the performance. A pass is a prerequisite of the award of a service contract of similar nature. In this first attempt of the blind test, results were not satisfactory and it is concluded that 'S-service provider' and 'W-work procedure' amongst SWIMS contributed to most part of the unsatisfactory performance.+

Evaluation of the effects of performance dentistry on equine rideability: a randomized, blinded, controlled trial.

PubMed

Moine, Sébastien; Flammer, Shannon Axiak; de Jesus Maia-Nussbaumer, Päivi; Klopfenstein Bregger, Micaël D; Gerber, Vincent

2017-12-01

This study attempted to determine: (1) if degree of dental malocclusion assigned prior to dental treatment was associated with equine rideability, assessed using a standardized score and (2) if performance dentistry improved this score. Thirty-eight Franches-Montagnes stallions. All horses were examined and assigned a dental malocclusion score by a veterinary dentist and randomized into two groups: sham treatment (Group S) and performance dentistry including occlusal equilibration (Group D). The horses were ridden twice before and three times after treatment by a professional dressage rider (unaware of treatment allocation). The horses were assigned a rideability score using a 27-point scale. The malocclusion score was compared to the average of the first two rideability scores using Spearman's coefficient of rank. Change in rideability scores over time was assessed by repeated measures ANOVA. Statistical significance was set at P < 0.05. There was no correlation between dental score and rideability score prior to treatment (r s = 0.06, P = 0.73). In addition, there were no differences in the rideability score between treatment groups or as an interaction of treatment group and time (P = 0.93, P = 0.83, respectively). In conclusion, we were unable to show that performance dentistry improved equine rideability assessed by rider scoring. The addition of more objective measurement tools and a longer assessment period may help to scientifically prove what is anecdotally believed.

Bronchiectasis: correlation of high-resolution CT findings with health-related quality of life.

PubMed

Eshed, I; Minski, I; Katz, R; Jones, P W; Priel, I E

2007-02-01

To evaluate the relationship between the severity of bronchiectatic diseases, as evident on high-resolution computed tomography (HRCT) and the patient's quality of life measured using the St George's Respiratory Questionnaire (SGRQ). Forty-six patients (25 women, 21 men, mean age: 63 years) with bronchiectatic disease as evident on recent HRCT examinations were recruited. Each patient completed the SGRQ and underwent respiratory function tests. HRCT findings were blindly and independently scored by two radiologists, using the modified Bhalla scoring system. The relationships between HRCT scores, SGRQ scores and pulmonary function tests were evaluated. The patients' total CT score did not correlate with the SGRQ scores. However, patients with more advanced disease on HRCT, significantly differed in their SGRQ scores from patients with milder bronchiectatic disease. A significant correlation was found between the CT scores for the middle and distal lung zones and the activity, impacts and total SGRQ scores. No correlation was found between CT scores and respiratory function test indices. However, a significant correlation was found between the SGRQ scores and most of the respiratory function test indices. A correlation between the severity of bronchiectatic disease as expressed in HRCT and the health-related quality of life exists in patients with a more severe bronchiectatic disease but not in patients with mild disease. Such correlation depends on the location of the bronchiectasis in the pulmonary tree.

Burden and depression in the caregivers of blind patients in India.

PubMed

Braich, Puneet S; Lal, Vikram; Hollands, Simon; Almeida, David R

2012-02-01

Several studies have examined the rates of depression in caregivers of patients with debilitating neurologic diseases. This study describes the degree of burden and the prevalence of depression among individuals caring for legally blind patients. To the best of our knowledge, no prior studies in the ophthalmic literature have reported this relationship. Clinic-based, cross-sectional study. We included 522 individuals in Rampur, India, providing care to their close family relatives who were legally blind. Visual acuities varied from 20/200 in the best eye, to no light perception (NLP) in each eye. Several surveys were completed by the caregivers of patients whose sole impairment was visual, allowing us to quantitatively and selectively assess burden and depression among caregivers of blind patients. The Burden Index of Caregivers (BIC) was used to measure care burden and the Center for Epidemiologic Studies Depression scale was applied to determine depression. Caregivers of patients with NLP experience higher burden than caregivers of patients with lesser degrees of blindness. Daily hours spent on close supervision and the intensity of care-giving were the definitive factors linked to high BIC scores (P<0.01). The prevalence of caregiver depression increased with degree of visual impairment from 16% in the 20/200 group to 48% in the NLP cohort (P<0.01). Independently related variables for depression in caregivers were daily hours required for close supervision of the patient, intensity of care-giving, low household income, and the caregiver being the parent of a blind adult child (P<0.01). Severity of blindness in patients directly correlated with burden in caregivers. More severe forms of blindness meant patients require more help with their activities of daily living and additional hours of close supervision per day, both of which increase care burden. The same 2 factors also increase risk of caregiver depression along with low household income and the caregiver being the parent of a blind adult child. Awareness of the extent of burden and depression among caregivers of blind individuals is required by vision health personnel to identify at risk caregivers and implement effective interventions and support strategies. Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Mapping Seabird Sensitivity to Offshore Wind Farms

PubMed Central

Bradbury, Gareth; Trinder, Mark; Furness, Bob; Banks, Alex N.; Caldow, Richard W. G.; Hume, Duncan

2014-01-01

We present a Geographic Information System (GIS) tool, SeaMaST (Seabird Mapping and Sensitivity Tool), to provide evidence on the use of sea areas by seabirds and inshore waterbirds in English territorial waters, mapping their relative sensitivity to offshore wind farms. SeaMaST is a freely available evidence source for use by all connected to the offshore wind industry and will assist statutory agencies in assessing potential risks to seabird populations from planned developments. Data were compiled from offshore boat and aerial observer surveys spanning the period 1979–2012. The data were analysed using distance analysis and Density Surface Modelling to produce predicted bird densities across a grid covering English territorial waters at a resolution of 3 km×3 km. Coefficients of Variation were estimated for each grid cell density, as an indication of confidence in predictions. Offshore wind farm sensitivity scores were compiled for seabird species using English territorial waters. The comparative risks to each species of collision with turbines and displacement from operational turbines were reviewed and scored separately, and the scores were multiplied by the bird density estimates to produce relative sensitivity maps. The sensitivity maps reflected well the amassed distributions of the most sensitive species. SeaMaST is an important new tool for assessing potential impacts on seabird populations from offshore development at a time when multiple large areas of development are proposed which overlap with many seabird species’ ranges. It will inform marine spatial planning as well as identifying priority areas of sea usage by marine birds. Example SeaMaST outputs are presented. PMID:25210739

Oral health status and alveolar bone loss in treated leprosy patients of central India.

PubMed

Rawlani, S M; Rawlani, S; Degwekar, S; Bhowte, R R; Motwani, M

2011-01-01

A descriptive cross sectional study was carried out, in a group of 160 leprosy patients treated with multi drug therapy. The patients with age group of 25 to 60 year were considered. Out of 160 patients 50 patients were selected by simple random sampling technique for radiological assessments. Intra-oral periapical radiographs (6 for each patient) were taken. The paralleling long cone technique was used and radiographs were attached with grids so as to enable measuring the bone height. The grid was spaced in 1 mm marking and placed directly over the film. Clinical examination revealed that Prevalence of dental caries was 76.25% and periodontal disease was 78.75%. Mean DMFT score was 2.26. Mean OHI-S score was 3.50. Score for Gingival index was 1.60 and average loss of gingival attachment was 1.2 mm. Radiographic findings showed mean alveolar bone loss in maxillary anterior region to be 5.05 mm and in maxillary posterior region it was 4.92 mm. Alveolar bone loss in mandibular anterior region was 4.35 mm and in mandibular posterior region was 5.14 mm. Overall Dental Health Status of the leprosy patients was poor and needed more attention for dental care. There was also an increase in the alveolar bone loss, which was generalized. This bone loss could be due to advance stage of the disease or late approach to rehabilitation center, these patients also had peripheral neuropathy leading to hand and feet deformity in the form of claw hand or ulcer on hand, making maintenance of oral hygiene difficult.

Functional redundancy of ventral spinal locomotor pathways.

PubMed

Loy, David N; Magnuson, David S K; Zhang, Y Ping; Onifer, Stephen M; Mills, Michael D; Cao, Qi-lin; Darnall, Jessica B; Fajardo, Lily C; Burke, Darlene A; Whittemore, Scott R

2002-01-01

Identification of long tracts responsible for the initiation of spontaneous locomotion is critical for spinal cord injury (SCI) repair strategies. Pathways derived from the mesencephalic locomotor region and pontomedullary medial reticular formation responsible for fictive locomotion in decerebrate preparations project to the thoracolumbar levels of the spinal cord via reticulospinal axons in the ventrolateral funiculus (VLF). However, white matter regions critical for spontaneous over-ground locomotion remain unclear because cats, monkeys, and humans display varying degrees of locomotor recovery after ventral SCIs. We studied the contributions of myelinated tracts in the VLF and ventral columns (VC) to spontaneous over-ground locomotion in the adult rat using demyelinating lesions. Animals received ethidium bromide plus photon irradiation producing discrete demyelinating lesions sufficient to stop axonal conduction in the VLF, VC, VLF-VC, or complete ventral white matter (CV). Behavior [open-field Basso, Beattie, and Bresnahan (BBB) scores and grid walking] and transcranial magnetic motor-evoked potentials (tcMMEP) were studied at 1, 2, and 4 weeks after lesion. VLF lesions resulted in complete loss or severe attenuation of tcMMEPs, with mean BBB scores of 18.0, and no grid walking deficits. VC lesions produced behavior similar to VLF-lesioned animals but did not significantly affect tcMMEPs. VC-VLF and CV lesions resulted in complete loss of tcMMEP signals with mean BBB scores of 12.7 and 6.5, respectively. Our data support a diffuse arrangement of axons within the ventral white matter that may comprise a system of multiple descending pathways subserving spontaneous over-ground locomotion in the intact animal.

Mapping seabird sensitivity to offshore wind farms.

PubMed

Bradbury, Gareth; Trinder, Mark; Furness, Bob; Banks, Alex N; Caldow, Richard W G; Hume, Duncan

2014-01-01

We present a Geographic Information System (GIS) tool, SeaMaST (Seabird Mapping and Sensitivity Tool), to provide evidence on the use of sea areas by seabirds and inshore waterbirds in English territorial waters, mapping their relative sensitivity to offshore wind farms. SeaMaST is a freely available evidence source for use by all connected to the offshore wind industry and will assist statutory agencies in assessing potential risks to seabird populations from planned developments. Data were compiled from offshore boat and aerial observer surveys spanning the period 1979-2012. The data were analysed using distance analysis and Density Surface Modelling to produce predicted bird densities across a grid covering English territorial waters at a resolution of 3 km×3 km. Coefficients of Variation were estimated for each grid cell density, as an indication of confidence in predictions. Offshore wind farm sensitivity scores were compiled for seabird species using English territorial waters. The comparative risks to each species of collision with turbines and displacement from operational turbines were reviewed and scored separately, and the scores were multiplied by the bird density estimates to produce relative sensitivity maps. The sensitivity maps reflected well the amassed distributions of the most sensitive species. SeaMaST is an important new tool for assessing potential impacts on seabird populations from offshore development at a time when multiple large areas of development are proposed which overlap with many seabird species' ranges. It will inform marine spatial planning as well as identifying priority areas of sea usage by marine birds. Example SeaMaST outputs are presented.

A randomized, double-blind study of the efficacy and tolerability of extended-release quetiapine fumarate (quetiapine XR) monotherapy in patients with major depressive disorder

PubMed Central

Wang, Gang; McIntyre, Alexander; Earley, Willie R; Raines, Shane R; Eriksson, Hans

2014-01-01

Objectives To evaluate the efficacy and tolerability of once-daily extended release quetiapine fumarate (quetiapine XR) monotherapy in patients with major depressive disorder (MDD). Patients and methods This was a 10-week (8-week active treatment/2-week post-treatment) randomized, double-blind, placebo- and active-controlled study (D1448C00004). Patients received quetiapine XR 150 mg/day, escitalopram 10 mg/day, or placebo; patients with an inadequate response (<20% improvement in Montgomery–Åsberg Depression Rating Scale [MADRS] total score) at week two received double-dose treatment. The primary end point was week eight change from randomization in MADRS total score. Secondary end points included MADRS response (≥50% improvement) and remission (score ≤8); Hamilton Rating Scale for Depression total and item 1; Hamilton Rating Scale for Anxiety total, psychic, and somatic; Clinical Global Impressions – Severity of Illness total; Pittsburgh Sleep Quality Index (PSQI) global; and Quality of Life Enjoyment and Satisfaction Questionnaire – Short Form percentage maximum total scores. Tolerability was assessed throughout. Results A total of 471 patients was randomized. No significant improvements in MADRS total score were observed at week eight (last observation carried forward) with either active treatment (quetiapine XR, −17.21 [P=0.174]; escitalopram, −16.73 [P=0.346]) versus placebo (−15.61). There were no significant differences in secondary end points versus placebo, with the exception of week-eight change in PSQI global score (quetiapine XR, −4.96 [P<0.01] versus placebo, −3.37). Mixed-model repeated-measures analysis of observed-case data suggested that the primary analysis may not be robust. Most commonly reported adverse events included dry mouth, somnolence, and dizziness for quetiapine XR, and headache and nausea for escitalopram. Conclusion In this study, neither quetiapine XR (150/300 mg/day) nor escitalopram (10/20 mg/day) showed significant separation from placebo. Both compounds have been shown previously to be effective in the treatment of MDD; possible reasons for this failed study are discussed. Quetiapine XR was generally well tolerated, with a profile similar to that reported previously. PMID:24511235

Effects of enzyme-potentiated desensitization in the treatment of pollinosis: a double-blind placebo-controlled trial.

PubMed

Astarita, C; Scala, G; Sproviero, S; Franzese, A

1996-01-01

Several controlled clinical trials have shown that specific immunotherapy (SIT) using incremental injections of allergens can be effective in the treatment of allergic rhinitis and asthma. Nevertheless, the risk of side effects have led to some recommended limitations of SIT. Enzyme-potentiated desensitization (EPD) is a proposed method for immunotherapy with very low doses of mixed allergens plus beta-glucuronidase enzyme, for which irrelevant or no side effects have been claimed. The aim of this study was to determine the clinical efficacy of EPD in the treatment of pollinosis. A double-blind placebo-controlled trial of EPD among 20 patients sensitive to Parietaria and grass pollen was performed. All patients recorded daily symptom scores for nine months following a single intradermal injection of EPD or buffered saline received in February. Symptoms recorded were nasal itching and obstruction, sneezing, rhinorrhea, itchy eyes and excessive tear production. Moreover, total and specific lgE were measured and CD3+, CD4+ and CD8+ peripheral blood lymphocytes were counted at different times. In the same period, ten additional subjects, with an allergic clinical profile similar to the subjects admitted to the double-blind trial, were studied in an open clinical trial in order to evaluate the effects of EPD without enzyme using a mixture of allergens. Symptom scores were higher in the placebo group (p < 0.001), with a similar level of significance for both global symptom score and for each individual symptom. Active-treated patients had a significant post-treatment increase in the mean percentage of T-CD8+ peripheral blood cells and a significant post-seasonal decrease in the mean percentage of Parietaria specific lgE. On the contrary, placebo-treated patients had a borderline significant post-seasonal decrease in the mean percentage of CD8+ circulating cells and a significant seasonal increase in the mean percentage of Parietaria specific lgE with no significant post-seasonal decrease. Finally, clinical results of the mixture of allergens injection were similar to those of the placebo in the double-blind trial. EPD injection caused only an asymptomatic, local wheal and flare lasting about two hours. Two patients (20%) in the active-treated group experienced a delayed, mild, unusual headache lasting about two days. In conclusion, EPD is clinically effective in the treatment of pollinosis. Some immunological modifications observed in the EPD-treated patients suggest an EPD-induced enhancement of tolerogenic mechanisms like "immune deviation."

Alpha 2 LASSO Data Bundles

DOE Data Explorer

Gustafson, William Jr; Vogelmann, Andrew; Endo, Satoshi; Toto, Tami; Xiao, Heng; Li, Zhijin; Cheng, Xiaoping; Kim, Jinwon; Krishna, Bhargavi

2015-08-31

The Alpha 2 release is the second release from the LASSO Pilot Phase that builds upon the Alpha 1 release. Alpha 2 contains additional diagnostics in the data bundles and focuses on cases from spring-summer 2016. A data bundle is a unified package consisting of LASSO LES input and output, observations, evaluation diagnostics, and model skill scores. LES input include model configuration information and forcing data. LES output includes profile statistics and full domain fields of cloud and environmental variables. Model evaluation data consists of LES output and ARM observations co-registered on the same grid and sampling frequency. Model performance is quantified by skill scores and diagnostics in terms of cloud and environmental variables.

Monthly and seasonally verification of precipitation in Poland

NASA Astrophysics Data System (ADS)

Starosta, K.; Linkowska, J.

2009-04-01

The national meteorological service of Poland - the Institute of Meteorology and Water Management (IMWM) joined COSMO - The Consortium for Small Scale Modelling on July 2004. In Poland, the COSMO _PL model version 3.5 had run till June 2007. Since July 2007, the model version 4.0 has been running. The model runs in an operational mode at 14-km grid spacing, twice a day (00 UTC, 12 UTC). For scientific research also model with 7-km grid spacing is ran. Monthly and seasonally verification for the 24-hours (06 UTC - 06 UTC) accumulated precipitation is presented in this paper. The precipitation field of COSMO_LM had been verified against rain gauges network (308 points). The verification had been made for every month and all seasons from December 2007 to December 2008. The verification was made for three forecast days for selected thresholds: 0.5, 1, 2.5, 5, 10, 20, 25, 30 mm. Following indices from contingency table were calculated: FBI (bias), POD (probability of detection), PON (probability of detection of non event), FAR (False alarm rate), TSS (True sill statistic), HSS (Heidke skill score), ETS (Equitable skill score). Also percentile ranks and ROC-relative operating characteristic are presented. The ROC is a graph of the hit rate (Y-axis) against false alarm rate (X-axis) for different decision thresholds

Monthly and seasonally verification of precipitation in Poland

NASA Astrophysics Data System (ADS)

Starosta, K.; Linkowska, J.

2009-04-01

The national meteorological service of Poland - the Institute of Meteorology and Water Management (IMWM) joined COSMO - The Consortium for Small Scale Modelling on July 2004. In Poland, the COSMO _PL model version 3.5 had run till June 2007. Since July 2007, the model version 4.0 has been running. The model runs in an operational mode at 14-km grid spacing, twice a day (00 UTC, 12 UTC). For scientific research also model with 7-km grid spacing is ran. Monthly and seasonally verification for the 24-hours (06 UTC - 06 UTC) accumulated precipitation is presented in this paper. The precipitation field of COSMO_LM had been verified against rain gauges network (308 points). The verification had been made for every month and all seasons from December 2007 to December 2008. The verification was made for three forecast days for selected thresholds: 0.5, 1, 2.5, 5, 10, 20, 25, 30 mm. Following indices from contingency table were calculated: FBI (bias), POD (probability of detection), PON (probability of detection of non event), FAR (False alarm rate), TSS (True sill statistic), HSS (Heidke skill score), ETS (Equitable skill score). Also percentile ranks and ROC-relative operating characteristic are presented. The ROC is a graph of the hit rate (Y-axis) against false alarm rate (X-axis) for different decision thresholds.