Performance evaluation of a conformal thermal monitoring sheet (TMS) sensor array for measurement of surface temperature distributions during superficial hyperthermia treatments

PubMed Central

Arunachalam, K.; Maccarini, P.; Juang, T.; Gaeta, C.; Stauffer, P. R.

2009-01-01

Purpose This paper presents a novel conformal thermal monitoring sheet sensor array with differential thermal sensitivity for measuring temperature distributions over large surface areas. Performance of the sensor array is evaluated in terms of thermal accuracy, mechanical stability and conformity to contoured surfaces, probe self heating under irradiation from microwave and ultrasound hyperthermia sources, and electromagnetic field perturbation. Materials and Methods A prototype TMS with 4×4 array of fiberoptic sensors embedded between two flexible and thermally conducting polyimide films was developed as an alternative to the standard 1-2 mm diameter plastic catheter based probes used in clinical hyperthermia. Computed tomography images and bending tests were performed to evaluate the conformability and mechanical stability respectively. Irradiation and thermal barrier tests were conducted and thermal response of the prototype was compared with round cross-sectional clinical probes. Results Bending and conformity tests demonstrated higher flexibility, dimensional stability and close conformity to human torso. Minimal perturbation of microwave fields and low probe self heating was observed when irradiated with 915MHz microwave and 3.4MHz ultrasound sources. The transient and steady state thermal responses of the TMS array were superior compared to the clinical probes. Conclusions A conformal TMS sensor array with improved thermal sensitivity and dimensional stability was investigated for real-time skin temperature monitoring. This fixed-geometry, body-conforming array of thermal sensors allows fast and accurate characterization of two-dimensional temperature distributions over large surface areas. The prototype TMS demonstrates significant advantages over clinical probes for characterizing skin temperature distributions during hyperthermia treatments of superficial tissue disease. PMID:18465416

Evaluation of Nucleic Acid Stabilization Products for Ambient Temperature Shipping and Storage of Viral RNA and Antibody in a Dried Whole Blood Format

PubMed Central

Dauner, Allison L.; Gilliland, Theron C.; Mitra, Indrani; Pal, Subhamoy; Morrison, Amy C.; Hontz, Robert D.; Wu, Shuenn-Jue L.

2015-01-01

Loss of sample integrity during specimen transport can lead to false-negative diagnostic results. In an effort to improve upon the status quo, we used dengue as a model RNA virus to evaluate the stabilization of RNA and antibodies in three commercially available sample stabilization products: Whatman FTA Micro Cards (GE Healthcare Life Sciences, Pittsburgh, PA), DNAstāble Blood tubes (Biomātrica, San Diego, CA), and ViveST tubes (ViveBio, Alpharetta, GA). Both contrived and clinical dengue-positive specimens were stored on these products at ambient temperature or 37°C for up to 1 month. Antibody and viral RNA levels were measured by enzyme-linked immunosorbent assay (ELISA) and quantitative reverse transcription polymerase chain reaction (qRT-PCR) assays, respectively, and compared with frozen unloaded controls. We observed reduced RNA and antibody levels between stabilized contrived samples and frozen controls at our earliest time point, and this was particularly pronounced for the FTA cards. However, despite some time and temperature dependent loss, a 94.6–97.3% agreement was observed between stabilized clinical specimens and their frozen controls for all products. Additional considerations such as cost, sample volume, matrix, and ease of use should inform any decision to incorporate sample stabilization products into a diagnostic testing workflow. We conclude that DNAstāble Blood and ViveST tubes are useful alternatives to traditional filter paper for ambient temperature shipment of clinical specimens for downstream molecular and serological testing. PMID:25940193

Stability of conditioned pain modulation in two musculoskeletal pain models: investigating the influence of shoulder pain intensity and gender

PubMed Central

2013-01-01

Background Several chronic pain populations have demonstrated decreased conditioned pain modulation (CPM). However there is still a need to investigate the stability of CPM paradigms before the measure can be recommended for implementation. The purpose of the present study was to assess whether shoulder pain intensity and gender influence CPM stability within and between sessions. Methods This study examined two different musculoskeletal pain models, clinical shoulder pain and an experimental model of shoulder pain induced with eccentric exercise in healthy participants. Patients in the clinical cohort (N = 134) were tested before surgery and reassessed 3 months post-surgery. The healthy cohort (N = 190) was examined before inducing pain at the shoulder, and 48 and 96 hours later. Results Our results provide evidence that 1) stability of inhibition is not related to changes in pain intensity, and 2) there are sex differences for CPM stability within and between days. Conclusions Fluctuation of pain intensity did not significantly influence CPM stability. Overall, the more stable situations for CPM were females from the clinical cohort and males from the healthy cohort. PMID:23758907

Ten year rank-order stability of personality traits and disorders in a clinical sample

PubMed Central

Hopwood, Christopher J.; Morey, Leslie C.; Donnellan, M. Brent; Samuel, Douglas B.; Grilo, Carlos M.; McGlashan, Thomas H.; Shea, M. Tracie; Zanarini, Mary C.; Gunderson, John G.; Skodol, Andrew E.

2012-01-01

Objective To compare the 10-year retest stability of normal traits, pathological traits, and personality disorder dimensions in a clinical sample. Method Ten-year rank order stability estimates for the Revised NEO Personality Inventory, Schedule for Nonadaptive and Adaptive Personality, and Diagnostic Interview for DSM-IV Personality Disorders were evaluated before and after correcting for test-retest dependability and internal consistency in a clinical sample (N = 266). Results Dependability corrected stability estimates were generally in the range of .60–.90 for traits and .25–.65 for personality disorders. Conclusions The relatively lower stability of personality disorder symptoms may indicate important differences between pathological behaviors and relatively more stable self-attributed traits and imply that a full understanding of personality and personality pathology needs to take both traits and symptoms into account. The Five-Factor Theory distinction between basic tendencies and characteristic adaptations provides a theoretical framework for the separation of traits and disorders in terms of stability in which traits reflect basic tendencies that are stable and pervasive across situations, whereas personality disorder symptoms reflect characteristic maladaptations that are a function of both basic tendencies and environmental dynamics. PMID:22812532

Ten-year rank-order stability of personality traits and disorders in a clinical sample.

PubMed

Hopwood, Christopher J; Morey, Leslie C; Donnellan, M Brent; Samuel, Douglas B; Grilo, Carlos M; McGlashan, Thomas H; Shea, M Tracie; Zanarini, Mary C; Gunderson, John G; Skodol, Andrew E

2013-06-01

This study compares the 10-year retest stability of normal traits, pathological traits, and personality disorder dimensions in a clinical sample. Ten-year rank-order stability estimates for the Revised NEO Personality Inventory, Schedule for Nonadaptive and Adaptive Personality, and Diagnostic Interview for DSM-IV Personality Disorders were evaluated before and after correcting for test-retest dependability and internal consistency in a clinical sample (N = 266). Dependability-corrected stability estimates were generally in the range of.60-.90 for traits and.25-.65 for personality disorders. The relatively lower stability of personality disorder symptoms may indicate important differences between pathological behaviors and relatively more stable self-attributed traits and imply that a full understanding of personality and personality pathology needs to take both traits and symptoms into account. The five-factor theory distinction between basic tendencies and characteristic adaptations provides a theoretical framework for the separation of traits and disorders in terms of stability in which traits reflect basic tendencies that are stable and pervasive across situations, whereas personality disorder symptoms reflect characteristic maladaptations that are a function of both basic tendencies and environmental dynamics. © 2012 Wiley Periodicals, Inc.

Role of assessment tests in the stability of intelligence scoring of pre-school children with uneven/delayed cognitive profile.

PubMed

Yang, P; Jong, Y-J; Hsu, H-Y; Lung, F-W

2011-05-01

As part of an ongoing clinical service programme for pre-school children with developmental delay in an Asian developing country, we analysed the effect of three assessment tests, that is, Bayley Scale of Infant Development-II, Leiter International Performance Scale - Revised and Wechsler Preschool and Primary Scale of Intelligence - Revised - Chinese, on the stability of intelligence quotient (IQ) of children from pre-school through early childhood. The participants were 313 Taiwanese pre-school children with uneven or delayed cognitive profile and they were followed through early childhood. IQ stability was explored by different tests and among children of different clinical diagnosis: 168 children with non-autistic intellectual disability, 73 children with autism spectrum disorder, 58 children with mixed receptive-expressive language disorder and 14 children of other heterogeneous diagnoses. Stability of scores was evaluated using the r-squared for Pearson's coefficients to see the correlation between initial IQ (IQ1) and follow-up IQ (IQ2). Multiple linear regressions were also applied to see whether IQ1 had predictive ability for IQ2 and test-test difference in the total 313 children and each diagnostic subgroup. Results revealed that mean IQ1 was 65.8 ± 15.4 while mean IQ2 was 73.2 ± 17.9 for the total 313 children. The IQs were stable across an average follow-up duration of 38.6 ± 22.1 month from pre-school into early childhood. Patterns of positive correlations between IQ1 and IQ2 were noted by all the tests (r-squared = 0.43-0.5, all P < 0.001) and in the majority of diagnostic subgroups. Multiple regressions analysis also revealed that IQ1 could predict IQ2 significantly in all the tests (all P < 0.001). After careful choice of appropriate initial test, stability of IQ in children with developmental delay was noted from pre-school through early childhood. In addition, the translated version of cognitive assessment was valid for the required context of an Asian developing country. With the current emphasis on early identification and intervention for pre-school children with developmental delay, this information bears merit in clinical practice. © 2011 The Authors. Journal of Intellectual Disability Research © 2011 Blackwell Publishing Ltd.

Test-retest reliability of the Clinical Learning Environment, Supervision and Nurse Teacher (CLES + T) scale.

PubMed

Gustafsson, Margareta; Blomberg, Karin; Holmefur, Marie

2015-07-01

The Clinical Learning Environment, Supervision and Nurse Teacher (CLES + T) scale evaluates the student nurses' perception of the learning environment and supervision within the clinical placement. It has never been tested in a replication study. The aim of the present study was to evaluate the test-retest reliability of the CLES + T scale. The CLES + T scale was administered twice to a group of 42 student nurses, with a one-week interval. Test-retest reliability was determined by calculations of Intraclass Correlation Coefficients (ICCs) and weighted Kappa coefficients. Standard Error of Measurements (SEM) and Smallest Detectable Difference (SDD) determined the precision of individual scores. Bland-Altman plots were created for analyses of systematic differences between the test occasions. The results of the study showed that the stability over time was good to excellent (ICC 0.88-0.96) in the sub-dimensions "Supervisory relationship", "Pedagogical atmosphere on the ward" and "Role of the nurse teacher". Measurements of "Premises of nursing on the ward" and "Leadership style of the manager" had lower but still acceptable stability (ICC 0.70-0.75). No systematic differences occurred between the test occasions. This study supports the usefulness of the CLES + T scale as a reliable measure of the student nurses' perception of the learning environment within the clinical placement at a hospital. Copyright © 2015 Elsevier Ltd. All rights reserved.

Characterization of a whole, inactivated influenza (H5N1) vaccine.

PubMed

Tada, Yoshikazu

2008-11-01

Effective vaccines against the highly pathogenic influenza A/H5N1 virus are being developed worldwide. In Japan, two adjuvanted, inactivated, whole-virion influenza vaccines were recently developed and licensed as mock-up, pre-pandemic vaccine formulations by the Ministry of Health and Labor Welfare of Japan. During the vaccine design and development process, various obstacles were overcome and, in this report, we introduce the non clinical production, immunogenicity data in human and development process that was associated with egg-derived adjuvanted, inactivated, whole-virion influenza A (H5N1) vaccine. Pilot lots of H5N1 vaccine were produced using the avirulent H5N1 reference strain A/Vietnam/1194/2004 (H5N1) NIBRG-14 and administered following adsorption with aluminum hydroxide as an adjuvant. Quality control and formulation stability tests were performed before clinical trials were initiated (phase I-III). The research foundation for microbial diseases of Osaka University (BIKEN) carried out vaccine production, quality control, stability testing and the phase I clinical trial in addition to overseeing the licensing of this vaccine. Mitsubishi Chemical Safety Institute Ltd. carried out the non clinical pharmacological toxicity and safety studies and the Japanese medical association carried out the phase II/III trials. Phase I-III trials took place in 2006. The production processes were well controlled by established tests and validations. Vaccine quality was confirmed by quality control, stability and pre-clinical tests, and the vaccine was approved as a mock-up, pre-pandemic vaccine by the Ministry of Health and Labor Welfare of Japan. Numerous safety and efficacy procedures were carried out prior to the approval of the described vaccine formulation. Some of these procedures were of particular importance e.g., vaccine development, validation, and quality control tests that included strict monitoring of the hemagglutinin (HA) content of the vaccine formulations. Improving vaccine productivity, shortening the production period and improving antigen yield of the avirulent vaccine strains were also considered important vaccine development criteria.

The Reliability, Validity, and Evaluation of the Objective Structured Clinical Examination in Podiatry (Chiropody).

ERIC Educational Resources Information Center

Woodburn, Jim; Sutcliffe, Nick

1996-01-01

The Objective Structured Clinical Examination (OSCE), initially developed for undergraduate medical education, has been adapted for assessment of clinical skills in podiatry students. A 12-month pilot study found the test had relatively low levels of reliability, high construct and criterion validity, and good stability of performance over time.…

Diagnostic accuracy of the gravity stress test and clinical signs in cases of isolated supination-external rotation-type lateral malleolar fractures.

PubMed

Nortunen, S; Flinkkilä, T; Lantto, I; Kortekangas, T; Niinimäki, J; Ohtonen, P; Pakarinen, H

2015-08-01

We prospectively assessed the diagnostic accuracy of the gravity stress test and clinical findings to evaluate the stability of the ankle mortise in patients with supination-external rotation-type fractures of the lateral malleolus without widening of the medial clear space. The cohort included 79 patients with a mean age of 44 years (16 to 82). Two surgeons assessed medial tenderness, swelling and ecchymosis and performed the external rotation (ER) stress test (a reference standard). A diagnostic radiographer performed the gravity stress test. For the gravity stress test, the positive likelihood ratio (LR) was 5.80 with a 95% confidence interval (CI) of 2.75 to 12.27, and the negative LR was 0.15 (95% CI 0.07 to 0.35), suggesting a moderate change from the pre-test probability. Medial tenderness, both alone and in combination with swelling and/or ecchymosis, indicated a small change (positive LR, 2.74 to 3.25; negative LR, 0.38 to 0.47), whereas swelling and ecchymosis indicated only minimal changes (positive LR, 1.41 to 1.65; negative LR, 0.38 to 0.47). In conclusion, when gravity stress test results are in agreement with clinical findings, the result is likely to predict stability of the ankle mortise with an accuracy equivalent to ER stress test results. When clinical examination suggests a medial-side injury, however, the gravity stress test may give a false negative result. ©2015 The British Editorial Society of Bone & Joint Surgery.

Improved DNA hybridization parameters by Twisted Intercalating Nucleic Acid (TINA).

PubMed

Schneider, Uffe Vest

2012-01-01

This thesis establishes oligonucleotide design rules and applications of a novel group of DNA stabilizing molecules collectively called Twisted Intercalating Nucleic Acid - TINA. Three peer-reviewed publications form the basis for the thesis. One publication describes an improved and rapid method for determination of DNA melting points and two publications describe the effects of positioning TINA molecules in parallel triplex helix and antiparallel duplex helix forming DNA structures. The third publication establishes that TINA molecules containing oligonucleotides improve an antiparallel duplex hybridization based capture assay's analytical sensitivity compared to conventionel DNA oligonucleotides. Clinical microbiology is traditionally based on pathogenic microorganisms' culture and serological tests. The introduction of DNA target amplification methods like PCR has improved the analytical sensitivity and total turn around time involved in clinical diagnostics of infections. Due to the relatively weak hybridization between the two strands of double stranded DNA, a number of nucleic acid stabilizing molecules have been developed to improve the sensitivity of DNA based diagnostics through superior binding properties. A short introduction is given to Watson-Crick and Hoogsteen based DNA binding and the derived DNA structures. A number of other nucleic acid stabilizing molecules are described. The stabilizing effect of TINA molecules on different DNA structures is discussed and considered in relation to other nucleic acid stabilizing molecules and in relation to future use of TINA containing oligonucleotides in clinical diagnostics and therapy. In conclusion, design of TINA modified oligonucleotides for antiparallel duplex helixes and parallel triplex helixes follows simple purpose dependent rules. TINA molecules are well suited for improving multiplex PCR assays and can be used as part of novel technologies. Future research should test whether combinations of TINA molecules and other nucleic acid stabilizing molecules can increase analytical sensitivity whilst maintaining nucleobase mismatch discrimination in triplex helix based diagnostic assays.

INTRA-RATER RELIABILITY OF THE MULTIPLE SINGLE-LEG HOP-STABILIZATION TEST AND RELATIONSHIPS WITH AGE, LEG DOMINANCE AND TRAINING.

PubMed

Sawle, Leanne; Freeman, Jennifer; Marsden, Jonathan

2017-04-01

Balance is a complex construct, affected by multiple components such as strength and co-ordination. However, whilst assessing an athlete's dynamic balance is an important part of clinical examination, there is no gold standard measure. The multiple single-leg hop-stabilization test is a functional test which may offer a method of evaluating the dynamic attributes of balance, but it needs to show adequate intra-tester reliability. The purpose of this study was to assess the intra-rater reliability of a dynamic balance test, the multiple single-leg hop-stabilization test on the dominant and non-dominant legs. Intra-rater reliability study. Fifteen active participants were tested twice with a 10-minute break between tests. The outcome measure was the multiple single-leg hop-stabilization test score, based on a clinically assessed numerical scoring system. Results were analysed using an Intraclass Correlations Coefficient (ICC 2,1 ) and Bland-Altman plots. Regression analyses explored relationships between test scores, leg dominance, age and training (an alpha level of p = 0.05 was selected). ICCs for intra-rater reliability were 0.85 for the dominant and non-dominant legs (confidence intervals = 0.62-0.95 and 0.61-0.95 respectively). Bland-Altman plots showed scores within two standard deviations. A significant correlation was observed between the dominant and non-dominant leg on balance scores (R 2 =0.49, p<0.05), and better balance was associated with younger participants in their non-dominant leg (R 2 =0.28, p<0.05) and their dominant leg (R 2 =0.39, p<0.05), and a higher number of hours spent training for the non-dominant leg R 2 =0.37, p<0.05). The multiple single-leg hop-stabilisation test demonstrated strong intra-tester reliability with active participants. Younger participants who trained more, have better balance scores. This test may be a useful measure for evaluating the dynamic attributes of balance. 3.

Initial stability of press-fit acetabular components under rotational forces.

PubMed

Fehring, Keith A; Owen, John R; Kurdin, Anton A; Wayne, Jennifer S; Jiranek, William A

2014-05-01

The primary goal of this study was to determine the initial press-fit stability in acetabular components without screw fixation. Mechanical testing was performed with the implantation of press-fit acetabular components in cadaveric specimens. No significant difference was found in load to failure testing between 1 and 2 mm of under-reaming. However, there was significant variability in bending forces required to create 150 μm of micromotion ranging from 49.3 N to 214.4 N. This study shows that cups implanted in a press-fit fashion, which are felt to be clinically stable, have high degrees of variability in resisting load and may be at risk for loosening. There is a need for more objective intra-operative techniques to test cup stability. © 2014.

Effects of youth football on selected clinical measures of neurologic function: a pilot study.

PubMed

Munce, Thayne A; Dorman, Jason C; Odney, Tryg O; Thompson, Paul A; Valentine, Verle D; Bergeron, Michael F

2014-12-01

We assessed 10 youth football players (13.4 ± 0.7 y) immediately before and after their season to explore the effects of football participation on selected clinical measures of neurologic function. Postseason postural stability in a closed-eye condition was improved compared to preseason (P = .017). Neurocognitive testing with the Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) battery revealed that reaction time was significantly faster at postseason (P = .015). There were no significant preseason versus postseason differences in verbal memory (P = .507), visual memory (P = .750), or visual motor speed (P = .087). Oculomotor performance assessed by the King-Devick test was moderately to significantly improved (P = .047-.115). A 12-week season of youth football did not impair the postural stability, neurocognitive function, or oculomotor performance measures of the players evaluated. Though encouraging, continued and more comprehensive investigations of this at-risk population are warranted. © The Author(s) 2013.

The Latent Structure and Test-Retest Stability of Connected Language Measures in the Wisconsin Registry for Alzheimer's Prevention (WRAP).

PubMed

Mueller, Kimberly D; Koscik, Rebecca L; Clark, Lindsay R; Hermann, Bruce P; Johnson, Sterling C; Turkstra, Lyn S

2017-11-24

While it is well known that discourse-related language functions are impaired in the dementia phase of Alzheimer's Disease (AD), the presymptomatic temporal course of discourse dysfunction are not known earlier in the course of AD. To conduct discourse-related studies in this phase of AD, validated psychometric instruments are needed. This study investigates the latent structure, validity, and test-retest stability of discourse measures in a late-middle-aged normative group who are relatively free from sporadic AD risk factors. Using a normative sample of 399 participants (mean age = 61), exploratory factor analyses (EFA) and confirmatory factor analyses (CFA) were conducted on 18 measures of connected language derived from picture descriptions. Factor invariance across sex and family history and longitudinal test-retest stability measures were calculated. The EFA revealed a four-factor solution, consisting of semantic, syntax, fluency, and lexical constructs. The CFA model substantiated the structure, and factors were invariant across sex and parental history of AD status. Test-retest stability measures were within acceptable ranges. Results confirm a factor structure that is invariant across sex and parental AD history. The factor structure could be useful in similar cohorts designed to detect early language decline in investigations of preclinical or clinical AD or as outcome measures in clinical prevention trials. © The Author 2017. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Best Practices in Stability Indicating Method Development and Validation for Non-clinical Dose Formulations.

PubMed

Henry, Teresa R; Penn, Lara D; Conerty, Jason R; Wright, Francesca E; Gorman, Gregory; Pack, Brian W

2016-11-01

Non-clinical dose formulations (also known as pre-clinical or GLP formulations) play a key role in early drug development. These formulations are used to introduce active pharmaceutical ingredients (APIs) into test organisms for both pharmacokinetic and toxicological studies. Since these studies are ultimately used to support dose and safety ranges in human studies, it is important to understand not only the concentration and PK/PD of the active ingredient but also to generate safety data for likely process impurities and degradation products of the active ingredient. As such, many in the industry have chosen to develop and validate methods which can accurately detect and quantify the active ingredient along with impurities and degradation products. Such methods often provide trendable results which are predictive of stability, thus leading to the name; stability indicating methods. This document provides an overview of best practices for those choosing to include development and validation of such methods as part of their non-clinical drug development program. This document is intended to support teams who are either new to stability indicating method development and validation or who are less familiar with the requirements of validation due to their position within the product development life cycle.

The effect of accelerated ageing on colour stability of visible light-cured (VLC) chairside denture liners.

PubMed

Kostoulas, Ioannis; Polyzois, Gregory; Mitsoudis, Anastasios; Kavoura, Victoria; Frangou, Maria

2012-06-01

The purpose of this study was to assess the colour stability of seven visible light-cured (VLC) hard and soft denture liners by an in vitro accelerated ageing test and compare them with two autopolymerised hard and soft liners. Ten specimens of each material were fabricated. The initial colour was measured with a tri-stimulus colorimeter. One set of five specimens was placed in distilled water at 37°C in the dark for 15 days, while the remaining were subjected to UV/visible light-accelerated ageing initially for 24 h and then for 144 h. Colour change (ΔΕ) was calculated. Data were statistically analysed by anova, Tukey and t-tests at α = 0.05. All the liners showed clinically acceptable colour change (ΔΕ ≤ 6.8) in distilled water. The colour changes after ageing for Triad DuaLine, Lightdon U, Ufi Gel H and Light Liner Hard were clinically unacceptable (ΔΕ ≥ 6.8), whereas LightLiner Soft, Astron LC Soft, Triad Resiline and Flexacryl Soft presented slighter and clinically acceptable colour change (ΔΕ ≤ 6.8). Accelerated ageing affected significantly the colour stability of all denture liners tested except Astron LC Soft. Soft VLC denture liners were more colour-stable than hard VLC liners. © 2011 The Gerodontology Society and John Wiley & Sons A/S.

Impact of a new sampling buffer on faecal haemoglobin stability in a colorectal cancer screening programme by the faecal immunochemical test.

PubMed

Grazzini, Grazia; Ventura, Leonardo; Rubeca, Tiziana; Rapi, Stefano; Cellai, Filippo; Di Dia, Pietro P; Mallardi, Beatrice; Mantellini, Paola; Zappa, Marco; Castiglione, Guido

2017-07-01

Haemoglobin (Hb) stability in faecal samples is an important issue in colorectal cancer screening by the faecal immunochemical test (FIT) for Hb. This study evaluated the performance of the FIT-Hb (OC-Sensor Eiken) used in the Florence screening programme by comparing two different formulations of the buffer, both in an analytical and in a clinical setting. In the laboratory simulation, six faecal pools (three in each buffer type) were stored at different temperatures and analysed eight times in 10 replicates over 21 days. In the clinical setting, 7695 screenees returned two samples, using both the old and the new specimen collection device (SCD). In the laboratory simulation, 5 days from sample preparation with the buffer of the old SCD, the Hb concentration decreased by 40% at room temperature (25°C, range 22-28°C) and up to 60% at outside temperature (29°C, range 16-39°C), whereas with the new one, Hb concentration decreased by 10%. In the clinical setting, a higher mean Hb concentration with the new SCD compared with the old one was found (6.3 vs. 5.0 µg Hb/g faeces, respectively, P<0.001); no statistically significant difference was found in the probability of having a positive result in the two SCDs. Better Hb stability was observed with the new buffer under laboratory conditions, but no difference was found in the clinical performance. In our study, only marginal advantages arise from the new buffer. Improvements in sample stability represent a significant target in the screening setting.

Test-retest reliability and stability of N400 effects in a word-pair semantic priming paradigm.

PubMed

Kiang, Michael; Patriciu, Iulia; Roy, Carolyn; Christensen, Bruce K; Zipursky, Robert B

2013-04-01

Elicited by any meaningful stimulus, the N400 event-related potential (ERP) component is reduced when the stimulus is related to a preceding one. This N400 semantic priming effect has been used to probe abnormal semantic relationship processing in clinical disorders, and suggested as a possible biomarker for treatment studies. Validating N400 semantic priming effects as a clinical biomarker requires characterizing their test-retest reliability. We assessed test-retest reliability of N400 semantic priming in 16 healthy adults who viewed the same related and unrelated prime-target word pairs in two sessions one week apart. As expected, N400 amplitudes were smaller for related versus unrelated targets across sessions. N400 priming effects (amplitude differences between unrelated and related targets) were highly correlated across sessions (r=0.85, P<0.0001), but smaller in the second session due to larger N400s to related targets. N400 priming effects have high reliability over a one-week interval. They may decrease with repeat testing, possibly because of motivational changes. Use of N400 priming effects in treatment studies should account for possible magnitude decreases with repeat testing. Further research is needed to delineate N400 priming effects' test-retest reliability and stability in different age and clinical groups, and with different stimulus types. Copyright © 2012 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

Reliability and Construct Validity of Limits of Stability Test in Adolescents Using a Portable Forceplate System.

PubMed

Alsalaheen, Bara; Haines, Jamie; Yorke, Amy; Broglio, Steven P

2015-12-01

To examine the reliability, convergent, and discriminant validity of the limits of stability (LOS) test to assess dynamic postural stability in adolescents using a portable forceplate system. Cross-sectional reliability observational study. School setting. Adolescents (N=36) completed all measures during the first session. To examine the reliability of the LOS test, a subset of 15 participants repeated the LOS test after 1 week. Not applicable. Outcome measurements included the LOS test, Balance Error Scoring System, Instrumented Balance Error Scoring System, and Modified Clinical Test for Sensory Interaction on Balance. A significant relation was observed among LOS composite scores (r=.36-.87, P<.05). However, no relation was observed between LOS and static balance outcome measurements. The reliability of the LOS composite scores ranged from moderate to good (intraclass correlation coefficient model 2,1=.73-.96). The results suggest that the LOS composite scores provide unique information about dynamic postural stability, and the LOS test completed at 100% of the theoretical limit appeared to be a reliable test of dynamic postural stability in adolescents. Clinicians should use dynamic balance measurement as part of their balance assessment and should not use static balance testing (eg, Balance Error Scoring System) to make inferences about dynamic balance, especially when balance assessment is used to determine rehabilitation outcomes, or when making return to play decisions after injury. Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Trunk postural adjustments: Medium-term reliability and correlation with changes of clinical outcomes following an 8-week lumbar stabilization exercise program.

PubMed

Boucher, Jean-Alexandre; Preuss, Richard; Henry, Sharon M; Nugent, Marilee; Larivière, Christian

2018-04-22

Low back pain (LBP) has been previously associated with delayed anticipatory postural adjustments (APAs) determined by trunk muscle activation. Lumbar stabilization exercise programs (LSEP) for patients with LBP may restore the trunk neuromuscular control of the lumbar spine, and normalize APAs. This exploratory study aimed at testing the reliability of EMG and kinematics-based postural adjustment measures over an 8-week interval, assessing their sensitivity to LBP status and treatment and examining their relationship with clinical outcomes. Muscle activation of 10 trunk muscles, using surface electromyography (EMG), and lumbar angular kinematics were recorded during a rapid arm-raising/lowering task. Patients with LBP were tested before and after an 8-week LSEP. Healthy controls receiving no treatment were assessed over the same interval to determine the reliability of the measures and act as a control group at baseline. Muscle activation onsets and reactive range of motion, range of velocities and accelerations were assessed for between group differences at baseline and pre- to post-treatment effects within patients with LBP using t-tests. Correlations between these dependent variables and the change of clinical outcomes (pain, disability) over treatment were also explored. Kinematic-based measures showed comparable reliability to EMG-based measures. Between-group differences were found in lumbar lateral flexion ROM at baseline (patients < controls). In the patients with LBP, lateral flexion velocity and acceleration significantly increased following the LSEP. Correlational analyses revealed that lumbar angular kinematics were more sensitive to changes in pain intensity following the LSEP compared to EMG measures. These findings are interpreted in from the perspective of guarding behaviors and lumbar stability hypotheses. Future clinical trials are needed to target patients with and without delayed APAs at baseline and to explore the sensitivity of different outcome measures related to APAs. Different tasks more challenging to postural stability may need to be explored to more effectively reveal APA dysfunction. Copyright © 2018. Published by Elsevier Ltd.

Internal consistency and stability of the CANTAB neuropsychological test battery in children.

PubMed

Syväoja, Heidi J; Tammelin, Tuija H; Ahonen, Timo; Räsänen, Pekka; Tolvanen, Asko; Kankaanpää, Anna; Kantomaa, Marko T

2015-06-01

The Cambridge Neuropsychological Test Automated Battery (CANTAB) is a computer-assessed test battery widely use in different populations. The internal consistency and 1-year stability of CANTAB tests were examined in school-age children. Two hundred-thirty children (57% girls) from five schools in the Jyväskylä school district in Finland participated in the study in spring 2011. The children completed the following CANTAB tests: (a) visual memory (pattern recognition memory [PRM] and spatial recognition memory [SRM]), (b) executive function (spatial span [SSP], Stockings of Cambridge [SOC], and intra-extra dimensional set shift [IED]), and (c) attention (reaction time [RTI] and rapid visual information processing [RVP]). Seventy-four children participated in the follow-up measurements (64% girls) in spring 2012. Cronbach's alpha reliability coefficient was used to estimate the internal consistency of the nonhampering test, and structural equation models were applied to examine the stability of these tests. The reliability and the stability could not be determined for IED or SSP because of the nature of these tests. The internal consistency was acceptable only in the RTI task. The 1-year stability was moderate-to-good for the PRM, RTI, and RVP. The SSP and IED showed a moderate correlation between the two measurement points. The SRM and the SOC tasks were not reliable or stable measures in this study population. For research purposes, we recommend using structural equation modeling to improve reliability. The results suggest that the reliability and the stability of computer-based test batteries should be confirmed in the target population before using them for clinical or research purposes. (c) 2015 APA, all rights reserved).

Neonatal endocrine emergencies: a primer for the emergency physician.

PubMed

Park, Elizabeth; Pearson, Nadia M; Pillow, M Tyson; Toledo, Alexander

2014-05-01

The resuscitation principles of securing the airway and stabilizing hemodynamics remain the same in any neonatal emergency. However, stabilizing endocrine disorders may prove especially challenging. Several organ systems are affected simultaneously and the clinical presentation can be subtle. Although not all-inclusive, the implementation of newborn screening tests has significantly reduced morbidity and mortality in neonates. Implementing routine screening tests worldwide and improving the accuracy of present tests remains the challenge for healthcare providers. With further study of these disorders and best treatment practices we can provide neonates presenting to the emergency department with the best possible outcomes. Copyright © 2014 Elsevier Inc. All rights reserved.

Press-fit acetabular cup fixation: principles and testing.

PubMed

Macdonald, W; Carlsson, L V; Charnley, G J; Jacobsson, C M

1999-01-01

Pre-clinical testing of the fixation of press-fit acetabular components of total hip prostheses relies on cadaver or synthetic bone, but the properties and geometry of bone models differ from those of physiological bone. Cup designs use varied mechanisms for initial stability in bone; therefore, using different analogues and tests is appropriate. Press-fit cup stability was tested in the following: firstly, polyurethane (PU) foam modelling cancellous support; secondly, glass-fibre reinforced epoxide (GFRE) tubes modelling acetabular cortical support; thirdly, cadaveric acetabula. Three commercial cups [Harris-Galante II (H-G-II), Zimmer; Optifix, Smith & Nephew, Richards; porous coated anatomic (PCA), Howmedica] and an experimental cup with enhanced rim fixation were tested in three modes: direct pull-out, lever-out and axial torque. The fixation stabilities measured in the PU and the GFRE models showed trends consistent with those in cadaver bone, differing in the oversizing and cup geometry. The experimental cup was significantly more secure in most modes than other cups; the H-G II and Optifix cups showed similar stabilities, lower than that of the experimental cup but greater than that of the PCA cup (analysis of variance and Tukey's highly significant test; p < 0.001). The stabilities measured in cadaver bone more closely approximated those in GFRE. The use of several bone analogues enables separation of fixation mechanisms, allowing more accurate prediction of in vivo performance.

ASSOCIATIONS BETWEEN THREE CLINICAL ASSESSMENT TOOLS FOR POSTURAL STABILITY

PubMed Central

Saxion, Casie E.; Cameron, Kenneth L.; Gerber, J. Parry

2010-01-01

Study Design: Clinical Measurement, Correlation, Reliability Objectives: To assess the relationship between the Single Leg Balance (SLB), modified Balance Error Scoring System (mBESS), and modified Star Excursion Balance (mSEBT) tests and secondarily to assess inter-rater and test-retest reliability of these tests. Background: Ankle sprains often result in chronic instability and dysfunction. Several clinical tests assess postural deficits as a potential cause of this dysfunction; however, limited information exists pertaining to the relationship that these tests have with one another. Methods: Two independent examiners measured the performance of 34 healthy participants completing the SLB Test, mBESS test, and mSEBT at two different time periods. The relationship between tests was assessed using the Pearson Correlation and Fisher's Exact Tests. Inter-rater and test-retest reliability were assessed using the intraclass correlation coefficient (ICC) and Kappa statistics. Results: A significant correlation (r = -0.35) was observed between the mSEBT and the mBESS. Fisher's Exact Test showed a significant association between the SLB Test and mBESS (P = .048), but no association between the SLB and mSEBT (P = 1.000). Inter-rater reliability was excellent for the mSEBT and fair for the mBESS (ICCs of .91 and .61 respectively). Excellent agreement was observed between raters for the SLB test (k = 1.00). Test-retest reliability was excellent for the mSEBT (ICC = 0.98) and fair for the mBESS (ICC = 0.74). There was poor test-retest agreement for the SLB test (k = .211). Conclusion: There was a significant relationship observed between the SLB Test, mBESS test, and mSEBT: however; strength of association measures showed limited overlap between these tests. This suggests that these tests are interrelated but may not assess equal components of postural stability. PMID:21589668

Characterization of Femoral Component Initial Stability and Cortical Strain in a Reduced Stem-Length Design.

PubMed

Small, Scott R; Hensley, Sarah E; Cook, Paige L; Stevens, Rebecca A; Rogge, Renee D; Meding, John B; Berend, Michael E

2017-02-01

Short-stemmed femoral components facilitate reduced exposure surgical techniques while preserving native bone. A clinically successful stem should ideally reduce risk for stress shielding while maintaining adequate primary stability for biological fixation. We asked (1) how stem-length changes cortical strain distribution in the proximal femur in a fit-and-fill geometry and (2) if short-stemmed components exhibit primary stability on par with clinically successful designs. Cortical strain was assessed via digital image correlation in composite femurs implanted with long, medium, and short metaphyseal fit-and-fill stem designs in a single-leg stance loading model. Strain was compared to a loaded, unimplanted femur. Bone-implant micromotion was then compared with reduced lateral shoulder short stem and short tapered-wedge designs in cyclic axial and torsional testing. Femurs implanted with short-stemmed components exhibited cortical strain response most closely matching that of the intact femur model, theoretically reducing the potential for proximal stress shielding. In micromotion testing, no difference in primary stability was observed as a function of reduced stem length within the same component design. Our findings demonstrate that within this fit-and-fill stem design, reduction in stem length improved proximal cortical strain distribution and maintained axial and torsional stability on par with other stem designs in a composite femur model. Short-stemmed implants may accommodate less invasive surgical techniques while facilitating more physiological femoral loading without sacrificing primary implant stability. Copyright © 2016 Elsevier Inc. All rights reserved.

SMD 3 post test medical report

NASA Technical Reports Server (NTRS)

Hordinsky, J. R.

1977-01-01

One of several reports that were prepared to document the results of the Spacelab Mission Development Test 3 is presented. This report covers clinical support to the crew as well as assistance and counsel to others in crew selection, health stabilization of the crew and the laboratory animals, and habitability and duty schedules.

A critical analysis of test-retest reliability in instrument validation studies of cancer patients under palliative care: a systematic review

PubMed Central

2014-01-01

Background Patient-reported outcome validation needs to achieve validity and reliability standards. Among reliability analysis parameters, test-retest reliability is an important psychometric property. Retested patients must be in a clinically stable condition. This is particularly problematic in palliative care (PC) settings because advanced cancer patients are prone to a faster rate of clinical deterioration. The aim of this study was to evaluate the methods by which multi-symptom and health-related qualities of life (HRQoL) based on patient-reported outcomes (PROs) have been validated in oncological PC settings with regards to test-retest reliability. Methods A systematic search of PubMed (1966 to June 2013), EMBASE (1980 to June 2013), PsychInfo (1806 to June 2013), CINAHL (1980 to June 2013), and SCIELO (1998 to June 2013), and specific PRO databases was performed. Studies were included if they described a set of validation studies. Studies were included if they described a set of validation studies for an instrument developed to measure multi-symptom or multidimensional HRQoL in advanced cancer patients under PC. The COSMIN checklist was used to rate the methodological quality of the study designs. Results We identified 89 validation studies from 746 potentially relevant articles. From those 89 articles, 31 measured test-retest reliability and were included in this review. Upon critical analysis of the overall quality of the criteria used to determine the test-retest reliability, 6 (19.4%), 17 (54.8%), and 8 (25.8%) of these articles were rated as good, fair, or poor, respectively, and no article was classified as excellent. Multi-symptom instruments were retested over a shortened interval when compared to the HRQoL instruments (median values 24 hours and 168 hours, respectively; p = 0.001). Validation studies that included objective confirmation of clinical stability in their design yielded better results for the test-retest analysis with regard to both pain and global HRQoL scores (p < 0.05). The quality of the statistical analysis and its description were of great concern. Conclusion Test-retest reliability has been infrequently and poorly evaluated. The confirmation of clinical stability was an important factor in our analysis, and we suggest that special attention be focused on clinical stability when designing a PRO validation study that includes advanced cancer patients under PC. PMID:24447633

The current evidence base for the feasibility of 48-hour continuous subcutaneous infusions (CSCIs): A systematically-structured review.

PubMed

Baker, James; Dickman, Andrew; Mason, Stephen; Ellershaw, John

2018-01-01

A continuous subcutaneous infusion (CSCI) is an effective method of multiple drug administration commonly encountered in end of life care when the oral route is compromised. At present, current practice is to limit syringe driver infusion time to a maximum of 24 hours as dictated by available chemical stability data. However, the ability to deliver prescribed medication by a CSCI over 48 hours may have numerous benefits in both patient care and health service resource utilisation. To examine and present the current evidence base for the stability of 48-hour multiple-drug CSCIs in current clinical practice. A systematically-structured review following PRISMA guidelines. Three electronic databases and the grey literature were searched with no time limits. Empirical studies reporting data on the chemical stability of continuous subcutaneous infusions or solutions stored in polypropylene syringes were included. Twenty-one empirical studies were included in this review reporting chemical compatibility and stability of 32 discrete combinations of twenty-four drugs tested at a variety of different drug concentrations. The majority of combinations reported were assessed as being chemically compatible. The greatest risk of clinically significant chemical degradation was observed with midazolam. Only one study reported the microbiological stability of the solution examined. There is currently limited evidence for the physical, chemical and microbiological stability of solutions for continuous subcutaneous infusion over a period of 48 hours. More stability data is required before the use of 48-hour CSCIs can be evaluated for use within clinical practice.

An interactional test of the reformulated helplessness theory of depression in women receiving clinical treatment for eating disorders.

PubMed

Rotenberg, Ken J; Costa, Paula; Trueman, Mark; Lattimore, Paul

2012-08-01

The study tested the Reformulated Helplessness model that individuals who show combined internal locus of control, high stability and high globality attributions for negative life events are prone to depression. Thirty-six women (M=29 years-8 months of age) receiving clinical treatment for eating disorders completed: the Attribution Style Questionnaire, the Beck Depression Inventory, and the Stirling Eating Disorder Scales. An HRA yielded a three-way interaction among the attributional dimensions on depressive symptoms. Plotting of the slopes showed that the attribution of negative life events to the combination of internal locus of control, high stability, and a high globality, was associated with the optimal level of depressive symptoms. The findings supported the Reformulated Helplessness as a model of depression. Copyright © 2012 Elsevier Ltd. All rights reserved.

Formulation, stability testing, and analytical characterization of melatonin-based preparation for clinical trial.

PubMed

Filali, Samira; Bergamelli, Charlotte; Lamine Tall, Mamadou; Salmon, Damien; Laleye, Diane; Dhelens, Carole; Diouf, Elhadji; Pivot, Christine; Pirot, Fabrice

2017-08-01

A new institutional clinical trial assessed the improvement of sleep disorders in 40 children with autism treated by immediate-release melatonin formulation in different regimens (0.5 mg, 2 mg, and 6 mg daily) for one month. The objectives of present study were to (i) prepare low-dose melatonin hard capsules for pediatric use controlled by two complementary methods and (ii) carry out a stability study in order to determine a use-by-date. Validation of preparation process was claimed as ascertained by mass uniformity of hard capsules. Multicomponent analysis by attenuated total reflectance Fourier transformed infrared (ATR-FTIR) of melatonin/microcrystalline cellulose mixture allowed to identify and quantify relative content of active pharmaceutical ingredients and excipients. Absolute melatonin content analysis by high performance liquid chromatography in 0.5 mg and 6 mg melatonin capsules was 93.6%±4.1% and 98.7%±6.9% of theoretical value, respectively. Forced degradation study showed a good separation of melatonin and its degradation products. The capability of the method was 15, confirming a risk of false negative <0.01%. Stability test and dissolution test were compliant over 18 months of storage with European Pharmacopoeia. Preparation of melatonin hard capsules was completed manually and melatonin in hard capsules was stable for 18 months, in spite of low doses of active ingredient. ATR-FTIR offers a real alternative to HPLC for quality control of high-dose melatonin hard capsules before the release of clinical batches.

Biomechanical study of patellofemoral joint instability

NASA Astrophysics Data System (ADS)

Senavongse, Wongwit

2005-04-01

Patellofemoral joint instability is a complex clinical problem. It may be a consequence of pre-existing anatomical abnormality or trauma. The objectives of this study were to use experimental mechanics to measure patellar stability and to quantify the effects of pathological abnormalities on patellar stability in vitro. Eight fresh-frozen cadaver knees were studies. The patellar stability was measured using an Instron material testing machine. A total load of 175N was applied to the quadriceps muscles. Patellar force-displacement was tested at different knee flexion angles as the patella was cyclically displaced 10mm laterally and medially. Three pathological abnormalities were applied; VMO malfunction, flat lateral trochlea, and medial retinacular structure rupturing. For the first time, this study has shown comparative and quantitative influence of pathological abnormalities on patellar stability. It was found that a flat lateral trochlea has greater effect than the medial retinacular rupturing whereas the medial retinacular rupturing has greater effect than VMO malfunction on patellar lateral stability. These results are important for future investigations on the treatment of patellofemoral instability.

3D Optical Investigation of 2 Nail Systems Used in Tibiotalocalcaneal Arthrodesis: A Biomechanical Study.

PubMed

Evers, Julia; Lakemeier, Martin; Wähnert, Dirk; Schulze, Martin; Richter, Martinus; Raschke, Michael J; Ochman, Sabine

2017-05-01

Although retrograde intramedullary nails for tibiotalocalcaneal arthrodesis (TTCA) are an established fixation method, few studies have evaluated the stability of the available nail systems. The purpose of this study was to compare biomechanically the primary stability of 2 nail-systems, A3 (Small Bone Innovations) and HAN (Synthes), in human cadavers and analyze the exact point of instability in TTCA by means of optical measurement. In 6 pairs of lower legs (n = 12) of fresh-frozen human cadavers with osteoporotic bone structure, bone mineral density (BMD) was determined. Pairwise randomized implantation of either an HAN or A3 nail was executed. Performance and stability were measured by quasi-static tests using 3D motion tracking (NDI Optotrak-Certus) followed by cyclic loading tests during dorsi- and plantarflexion. 3D optical analysis in quasi-static tests showed a significantly lower degree of movement for the HAN nail in rotational and dorsi-/plantarflexion, especially in the subtalar joint. Cyclic loading tests were consistent with quasi-static tests. The A3 nail offered lower stability during axial torsion in the ankle and subtalar joints and during plantar- and dorsiflexion in the subtalar joint in osteoporotic bones. This study was the first to examine the primary stability of different arthrodesis nails in TTCA and their bony parts with a 3D motion analysis. The better stability of the locking-only HAN nail in this osteoporotic test setup could lead to more favorable results in comparison to the A3 nail in clinical use.

Vapor Pressure and Predicted Stability of American Contact Dermatitis Society Core Allergens

PubMed Central

Jou, Paul C.; Siegel, Paul D.; Warshaw, Erin M.

2018-01-01

Background Accurate patch testing is reliant on proper preparation of patch test allergens. The stability of patch test allergens is dependent on several factors including vapor pressure (VP). Objective This investigation reviews the VP of American Contact Dermatitis Society Core Allergens and compares stability predictions based on VP with those established through clinical testing. Methods Standard references were accessed for determining VP in millimeters of mercury and associated temperature in degrees celsius. If multiple values were listed, VP at temperatures that most approximate indoor storage conditions (20°C and 25°C) were chosen. For mixes, the individual component with the highest VP was chosen as the overall VP, assuming that the most volatile substance would evaporate first. Antigens were grouped into low (≤0.001 mm Hg), moderate (<1 to >0.001 mm Hg), and high (≥1 mm Hg) volatility using arbitrary cutoff values. Conclusions This review is consistent with previously reported data on formaldehyde, acrylates, and fragrance material instability. Given lack of testing data, VP can be useful in predicting patch test compound stability. Measures such as air-tight multidose reagent containers, sealed single-application dispensers, preparation of patches immediately before application, and storage at lower temperatures may remedy some of these issues. PMID:27427821

Reliability and validity of the closed kinetic chain upper extremity stability test.

PubMed

Lee, Dong-Rour; Kim, Laurentius Jongsoon

2015-04-01

[Purpose] The purpose of this study was to examine the reliability and validity of the Closed Kinetic Chain Upper Extremity Stability (CKCUES) test. [Subjects and Methods] A sample of 40 subjects (20 males, 20 females) with and without pain in the upper limbs was recruited. The subjects were tested twice, three days apart to assess the reliability of the CKCUES test. The CKCUES test was performed four times, and the average was calculated using the data of the last 3 tests. In order to test the validity of the CKCUES test, peak torque of internal/external shoulder rotation was measured using an isokinetic dynamometer, and maximum grip strength was measured using a hand dynamometer, and their Pearson correlation coefficients with the average values of the CKCUES test were calculated. [Results] The reliability of the CKCUES test was very high (ICC=0.97). The correlations between the CKCUES test and maximum grip strength (r=0.78-0.79), and the peak torque of internal/external shoulder rotation (r=0.87-0.94) were high indicating its validity. [Conclusion] The reliability and validity of the CKCUES test were high. The CKCUES test is expected to be used for clinical tests on upper limb stability at low price.

New testing options for diagnosing and grading dry eye disease.

PubMed

Foulks, Gary N; Pflugfelder, Stephen C

2014-06-01

To describe new options for diagnosis and severity grading of dry eye disease. Perspective on technological advancements to identify tear dysfunction and their value in diagnosing and grading dry eye disease. Evidence is presented on new and evolving technologies to measure tear stability, composition, and meniscus height and their role in dry eye diagnosis and therapeutic efficacy grading is assessed. Evolving concepts regarding pathogenesis and new technologies to evaluate the tears and ocular surface have improved the ability to diagnose, classify, and grade the severity of dry eye disease. New technologies include noninvasive imaging of tear stability and tear meniscus height as a measure of tear volume and tear composition (osmolarity, lacrimal factors, inflammatory mediators, growth and differentiation factors). Approved tests, such as tear osmolarity and tear imaging, are being integrated into clinical practice and may eventually supplant certain traditional tests that have greater variability and less sensitivity. Other tests, such as molecular assays of tears and conjunctival cells, are currently being used in studies investigating pathogenesis and therapeutic mechanism of action. They may eventually translate to routine clinical practice. New technologies have emerged that can noninvasively evaluate the tears and measure disease-associated compositional changes. These tests are being integrated into clinical practice and therapeutic trials for diagnosis, classification, and severity grading of dry eye disease. Copyright © 2014 Elsevier Inc. All rights reserved.

Clinical and arthroscopic outcome of single bundle anterior cruciate ligament reconstruction: Comparison of remnant preservation versus conventional technique.

PubMed

Choi, Sungwook; Kim, Myung-Ku; Kwon, Yong Suk; Kang, Hyunseong

2017-10-01

The purpose of this study was to compare the clinical outcomes and second-look arthroscopic findings of remnant preservation technique with those of conventional anterior cruciate ligament (ACL) reconstruction in single bundle ACL reconstructions. One hundred sixty two consecutive patients underwent ACL reconstruction by one surgeon, with 93 patients receiving remnant preservation technique (Group A) and 69 patients receiving conventional ACL reconstruction (Group B). The mean follow-up was 15months. Clinical outcomes were assessed using Lysholm scores and the International Knee Documentation Committee form (IKDC form) evaluation. Post-operative knee stability was evaluated through manual knee laxity evaluation, pivot-shift test, and a Telos device. Differences in post-operative stability (manual knee laxity, pivot shift test and Telos device) were not significant between the groups (p=0.681, p=0.610, p=0.696). And also no significant differences were noted with respect to the IKDC form and the latest Lysholm scores. But in the second-look arthroscopic findings, synovial coverage was confirmed to be excellent in 36% (22/61) of Group A patients and 23% (7/30) of Group B patients. ACL reconstruction with both techniques was found to result in acceptable stability, clinical outcomes and second-look arthroscopic findings. With regard to synovial coverage, the remnant reservation techniques were found to be superior to conventional ACL reconstruction. Level III, retrospective comparative study. Copyright © 2017 Elsevier B.V. All rights reserved.

Balance, mobility and gaze stability deficits remain following surgical removal of vestibular schwannoma (acoustic neuroma): an observational study.

PubMed

Choy, Nancy Low; Johnson, Natalie; Treleaven, Julia; Jull, Gwendolen; Panizza, Benedict; Brown-Rothwell, David

2006-01-01

Are there residual deficits in balance, mobility, and gaze stability after surgical removal of vestibular schwannoma? Observational study. Twelve people with a mean age of 52 years who had undergone surgical removal of vestibular schwannoma at least three months previously and had not undergone vestibular rehabilitation. Twelve age- and gender-matched healthy people who acted as controls. Handicap due to dizziness, balance, mobility, and gaze stability was measured. Handicap due to dizziness was moderate for the clinical group. They swayed significantly more than the controls in comfortable stance: firm surface eyes open and visual conflict (p < 0.05); foam surface eyes closed (p < 0.05) and visual conflict (p < 0.05); and feet together: firm surface, eyes closed (p < 0.05), foam surface, eyes open (p < 0.05) and eyes closed (p < 0.01). They displayed a higher rate of failure for timed stance and gaze stability (p < 0.05) than the controls. Step Test (p < 0.01), Tandem Walk Test (p < 0.05) and Dynamic Gait Index (p < 0.01) scores were also significantly reduced compared with controls. There was a significant correlation between handicap due to dizziness and the inability to maintain balance in single limb and tandem stance (r = 0.68, p = 0.02) and the ability to maintain gaze stability during passive head movement (r = 0.78; p = 0.02). A prospective study is required to evaluate vestibular rehabilitation to ameliorate dizziness and to improve balance, mobility, and gaze stability for this clinical group.

Quantitative psychomotor dysfunction in schizophrenia: a loss of drive, impaired movement execution or both?

PubMed

Docx, Lise; Sabbe, Bernard; Provinciael, Pieter; Merckx, Niel; Morrens, Manuel

2013-01-01

The aim of the present study was to investigate the predictive value of qualitative psychomotor performance levels and subaspects of the negative syndrome for quantitative motor activity levels in patients with schizophrenia. Twenty-seven stabilized patients with schizophrenia and 22 age- and sex-matched healthy controls were included in the study. An extensive battery of psychomotor performance tests (Finger Tapping Test, Purdue Pegboard Test, Line Copying Test, Neurological Evaluation Scale, Salpêtrière Retardation Rating Scale), clinical rating scales (Positive and Negative Syndrome Scale) and 24-hour actigraphy were administered to all participants. Correlational analyses showed that motor activity levels were associated with avolition as well as clinically assessed psychomotor slowing. However, in a regression model, only avolition was found to be a significant predictor for motor activity levels in patients with schizophrenia; none of the psychomotor performance tests nor the severity of emotional expressivity deficits contributed to the model. Qualitative and quantitative psychomotor deficits seem to be independent phenomena in stabilized patients with schizophrenia. The diminishing in motor activity in patients with schizophrenia is related to a loss of drive and not to problems in the quality of movement execution. © 2013 S. Karger AG, Basel.

The Effect of Spinal Tap Test on Different Sensory Modalities of Postural Stability in Idiopathic Normal Pressure Hydrocephalus.

PubMed

Abram, Katrin; Bohne, Silvia; Bublak, Peter; Karvouniari, Panagiota; Klingner, Carsten M; Witte, Otto W; Guntinas-Lichius, Orlando; Axer, Hubertus

2016-01-01

Postural instability in patients with normal pressure hydrocephalus (NPH) is a most crucial symptom leading to falls with secondary complications. The aim of the current study was to evaluate the therapeutic effect of spinal tap on postural stability in these patients. Seventeen patients with clinical symptoms of NPH were examined using gait scale, computerized dynamic posturography (CDP), and neuropsychological assessment. Examinations were done before and after spinal tap test. The gait score showed a significant improvement 24 h after spinal tap test in all subtests and in the sum score (p < 0.003), while neuropsychological assessment did not reveal significant differences 72 h after spinal tap test. CDP showed significant improvements after spinal tap test in the Sensory Organization Tests 2 (p = 0.017), 4 (p = 0.001), and 5 (p = 0.009) and the composite score (p = 0.01). Patients showed best performance in somatosensory and worst performance in vestibular dominated tests. Vestibular dominated tests did not improve significantly after spinal tap test, while somatosensory and visual dominated tests did. Postural stability in NPH is predominantly affected by deficient vestibular functions, which did not improve after spinal tap test. Conditions which improved best were mainly independent from visual control and are based on proprioceptive functions.

MALDI-TOF mass spectrometry and high-consequence bacteria: safety and stability of biothreat bacterial sample testing in clinical diagnostic laboratories.

PubMed

Tracz, Dobryan M; Tober, Ashley D; Antonation, Kym S; Corbett, Cindi R

2018-03-01

We considered the application of MALDI-TOF mass spectrometry for BSL-3 bacterial diagnostics, with a focus on the biosafety of live-culture direct-colony testing and the stability of stored extracts. Biosafety level 2 (BSL-2) bacterial species were used as surrogates for BSL-3 high-consequence pathogens in all live-culture MALDI-TOF experiments. Viable BSL-2 bacteria were isolated from MALDI-TOF mass spectrometry target plates after 'direct-colony' and 'on-plate' extraction testing, suggesting that the matrix chemicals alone cannot be considered sufficient to inactivate bacterial culture and spores in all samples. Sampling of the instrument interior after direct-colony analysis did not recover viable organisms, suggesting that any potential risks to the laboratory technician are associated with preparation of the MALDI-TOF target plate before or after testing. Secondly, a long-term stability study (3 years) of stored MALDI-TOF extracts showed that match scores can decrease below the threshold for reliable species identification (<1.7), which has implications for proficiency test panel item storage and distribution.

Does Repeated Testing Impact Concordance Between Genital and Self-Reported Sexual Arousal in Women?

PubMed

Velten, Julia; Chivers, Meredith L; Brotto, Lori A

2018-04-01

Women show a substantial variability in their genital and subjective responses to sexual stimuli. The level of agreement between these two aspects of response is termed sexual concordance and has been increasingly investigated because of its implications for understanding models of sexual response and as a potential endpoint in clinical trials of treatments to improve women's sexual dysfunction. However, interpreting changes in sexual concordance may be problematic because, to date, it still is unclear how repeated testing itself influences sexual concordance in women. We are aware of only one study that evaluated temporal stability of concordance in women, and it found no evidence of stability. However, time stability would be necessary for arguing that concordance is a stable individual difference. The main goal of this study was to investigate the test-retest reliability of sexual concordance in a sample of 30 women with sexual difficulties. Using hierarchical linear modeling, we found that sexual concordance was not influenced by repeated testing 12 weeks later, but showed test-retest reliability suggesting temporal stability. Our findings support the hypothesis that sexual concordance is a relatively stable individual difference and that changes in sexual concordance after treatment or experimental conditions could, therefore, be attributed to effects of those conditions.

The current evidence base for the feasibility of 48-hour continuous subcutaneous infusions (CSCIs): A systematically-structured review

PubMed Central

Dickman, Andrew; Mason, Stephen; Ellershaw, John

2018-01-01

Background A continuous subcutaneous infusion (CSCI) is an effective method of multiple drug administration commonly encountered in end of life care when the oral route is compromised. At present, current practice is to limit syringe driver infusion time to a maximum of 24 hours as dictated by available chemical stability data. However, the ability to deliver prescribed medication by a CSCI over 48 hours may have numerous benefits in both patient care and health service resource utilisation. Aim To examine and present the current evidence base for the stability of 48-hour multiple-drug CSCIs in current clinical practice. Design A systematically-structured review following PRISMA guidelines. Data sources Three electronic databases and the grey literature were searched with no time limits. Empirical studies reporting data on the chemical stability of continuous subcutaneous infusions or solutions stored in polypropylene syringes were included. Results Twenty-one empirical studies were included in this review reporting chemical compatibility and stability of 32 discrete combinations of twenty-four drugs tested at a variety of different drug concentrations. The majority of combinations reported were assessed as being chemically compatible. The greatest risk of clinically significant chemical degradation was observed with midazolam. Only one study reported the microbiological stability of the solution examined. Conclusions There is currently limited evidence for the physical, chemical and microbiological stability of solutions for continuous subcutaneous infusion over a period of 48 hours. More stability data is required before the use of 48-hour CSCIs can be evaluated for use within clinical practice. PMID:29538455

Stability studies of amphetamine and ephedrine derivatives in urine.

PubMed

Jiménez, C; de la Torre, R; Ventura, M; Segura, J; Ventura, R

2006-10-20

Knowledge of the stability of drugs in biological specimens is a critical consideration for the interpretation of analytical results. Identification of proper storage conditions has been a matter of concern for most toxicology laboratories (both clinical and forensic), and the stability of drugs of abuse has been extensively studied. This concern should be extended to other areas of analytical chemistry like antidoping control. In this work, the stability of ephedrine derivatives (ephedrine, norephedrine, methylephedrine, pseudoephedrine, and norpseudoephedrine), and amphetamine derivatives (amphetamine, methamphetamine, 3,4-methylenedioxyamphetamine (MDA), and 3,4-methylenedioxymethamphetamine (MDMA)) in urine has been studied. Spiked urine samples were prepared for stability testing. Urine samples were quantified by GC/NPD or GC/MS. The homogeneity of each batch of sample was verified before starting the stability study. The stability of analytes was evaluated in sterilized and non-sterilized urine samples at different storage conditions. For long-term stability testing, analyte concentration in urine stored at 4 degrees C and -20 degrees C was determined at different time intervals for 24 months for sterile urine samples, and for 6 months for non-sterile samples. For short-term stability testing, analyte concentration was evaluated in liquid urine stored at 37 degrees C for 7 days. The effect of repeated freezing (at -20 degrees C) and thawing (at room temperature) was also studied in sterile urine for up to three cycles. No significant loss of the analytes under study was observed at any of the investigated conditions. These results show the feasibility of preparing reference materials containing ephedrine and amphetamine derivatives to be used for quality control purposes.

Four-way-leaning test shows larger limits of stability than a circular-leaning test.

PubMed

Thomsen, Mikkel Højgaard; Støttrup, Nicolai; Larsen, Frederik Greve; Pedersen, Ann-Marie Sydow Krogh; Poulsen, Anne Grove; Hirata, Rogerio Pessoto

2017-01-01

Limits of stability (LOS) have extensive clinical and rehabilitational value yet no standard consensus on measuring LOS exists. LOS measured using a leaning or a circling protocol is commonly used in research and clinical settings, however differences in protocols and reliability problems exist. This study measured LOS using a four-way-leaning test and a circular-leaning test to test which showed larger LOS measurements. Furthermore, number of adaptation trials needed for consistent results was assessed. Limits of stability were measured using a force plate (Metitur Good Balance System ® ) sampling at 50Hz. Thirty healthy subjects completed 30 trials assessing LOS alternating between four-way-leaning test and circular-leaning test. A main effect of methods (ANOVA:F(1,28)=45.86, P<0.01) with the four-way-leaning test showing larger values than the circular-leaning test (NK, P<0.01). An interaction between method×directions was found (ANOVA:F(3, 84)=24.87, P<0.01). The four-way-leaning test showed larger LOS in anterior (NK, P<0.05), right (NK, P<0.01) and left direction (NK, P<0.01). Analysis of LOS for the four-way-leaning test showed a difference between trials (ANOVA:F(14,392)=7.81, P<0.01). Differences were found between trial 1 and 7 (NK, P<0.03), trial 6 and 8 (NK, P<0.02) and trial 7 and 15 (NK, P<0.02). Four-way-leaning test showed high correlation (ICC>0.87) between first and second trial for all directions. Four-way-leaning test yields larger LOS in anterior, right and left direction making it more reliable when measuring LOS. A learning effect was found up to the 8th trial, which suggests using 8 adaptation trials before reliable LOS is measured. Copyright © 2016 Elsevier B.V. All rights reserved.

Gaze Stabilization Test Asymmetry Score as an Indicator of Previous Concussion in a Cohort of Collegiate Football Players.

PubMed

Honaker, Julie A; Criter, Robin E; Patterson, Jessie N; Jones, Sherri M

2015-07-01

Vestibular dysfunction may lead to decreased visual acuity with head movements, which may impede athletic performance and result in injury. The purpose of this study was to test the hypothesis that athletes with history of concussion would have differences in gaze stabilization test (GST) as compared with those without a history of concussion. Cross-sectional, descriptive. University Athletic Medicine Facility. Fifteen collegiate football players with a history of concussion, 25 collegiate football players without a history of concussion. Participants completed the dizziness handicap inventory (DHI), static visual acuity, perception time test, active yaw plane GST, stability evaluation test (SET), and a bedside oculomotor examination. Independent samples t test was used to compare GST, SET, and DHI scores per group, with Bonferroni-adjusted alpha at P < 0.01. Receiver operating characteristic curve analysis and area under the curve (AUC) were used to assess the clinical performance of the GST and SET. Athletes with previous concussion had a larger GST asymmetry score [mean (M) = 12.40, SD = 9.09] than those without concussion (M = 4.92, SD = 4.67; t (18.70) = -2.955, P = 0.008, 95% CI, -12.79 to -2.18, d = -1.37). Clinical performance of the GST (AUC = 0.77) was better than the SET (AUC = 0.61). Results suggest peripheral vestibular or vestibular-visual interaction deficits in collegiate athletes with a history of concussion. The results support further research on the use of GST for sport-related concussion evaluation and monitoring. Inclusion of objective vestibular tests in the concussion protocol may reveal the presence of peripheral vestibular or visual-vestibular deficits. Therefore, the GST may add an important perspective on the effects of concussion.

Exploring for the optimal structural design for the 3D-printing technology for cranial reconstruction: a biomechanical and histological study comparison of solid vs. porous structure.

PubMed

Lim, Jun Young; Kim, Namhyun; Park, Jong-Chul; Yoo, Sun K; Shin, Dong Ah; Shim, Kyu-Won

2017-09-01

Cranioplasty for recovering skull defects carries the risk for a number of complications. Various materials are used, including autologous bone graft, metallic materials, and non-metallic materials, each of which has advantages and disadvantages. If the use of autologous bone is not feasible, those artificial materials also have constraints in the case of complex anatomy and/or irregular defects. This study used metal 3D-printing technology to overcome these existing drawbacks and analyze the clinical and mechanical performance requirements. To find an optimal structure that satisfied the structural and mechanical stability requirements, we evaluated biomechanical stability using finite element analysis (FEA) and mechanical testing. To ensure clinical applicability, the model was subjected to histological evaluation. Each specimen was implanted in the femur of a rabbit and was evaluated using histological measurements and push-out test. We believe that our data will provide the basis for future applications of a variety of unit structures and further clinical trials and research, as well as the direction for the study of other patient-specific implants.

Role of the fibula in the stability of diaphyseal tibial fractures fixed by intramedullary nailing.

PubMed

Galbraith, John G; Daly, Charles J; Harty, James A; Dailey, Hannah L

2016-10-01

For tibial fractures, the decision to fix a concomitant fibular fracture is undertaken on a case-by-case basis. To aid in this clinical decision-making process, we investigated whether loss of integrity of the fibula significantly destabilises midshaft tibial fractures, whether fixation of the fibula restores stability to the tibia, and whether removal of the fibula and interosseous membrane for expediency in biomechanical testing significantly influences tibial interfragmentary mechanics. Tibia/fibula pairs were harvested from six cadaveric donors with the interosseous membrane intact. A tibial osteotomy fracture was fixed by reamed intramedullary (IM) nailing. Axial, torsion, bending, and shear tests were completed for four models of fibular involvement: intact fibula, osteotomy fracture, fibular plating, and resected fibula and interosseous membrane. Overall construct stiffness decreased slightly with fibular osteotomy compared to intact bone, but this change was not statistically significant. Under low loads, the influence of the fibula on construct stability was only statistically significant in torsion (large effect size). Fibular plating stiffened the construct slightly, but this change was not statistically significant compared to the fibular osteotomy case. Complete resection of the fibula and interosseous membrane significantly decreased construct torsional stiffness only (large effect size). These results suggest that fixation of the fibula may not contribute significantly to the stability of diaphyseal tibial fractures and should not be undertaken unless otherwise clinically indicated. For testing purposes, load-sharing through the interosseous membrane contributes significantly to overall construct mechanics, especially in torsion, and we recommend preservation of these structures when possible. Copyright © 2016 Elsevier Ltd. All rights reserved.

Long-term reliability of ImPACT in professional ice hockey.

PubMed

Echemendia, Ruben J; Bruce, Jared M; Meeuwisse, Willem; Comper, Paul; Aubry, Mark; Hutchison, Michael

2016-02-01

This study sought to assess the test-retest reliability of Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) across 2-4 year time intervals and evaluate the utility of a newly proposed two-factor (Speed/Memory) model of ImPACT across multiple language versions. Test-retest data were collected from non-concussed National Hockey League (NHL) players across 2-, 3-, and 4-year time intervals. The two-factor model was examined using different language versions (English, French, Czech, Swedish) of the test using a one-year interval, and across 2-4 year intervals using the English version of the test. The two-factor Speed index improved reliability across multiple language versions of ImPACT. The Memory factor also improved but reliability remained below the traditional cutoff of .70 for use in clinical decision-making. ImPACT reliabilities remained low (below .70) regardless of whether the four-composite or the two-factor model was used across 2-, 3-, and 4-year time intervals. The two-factor approach increased ImPACT's one-year reliability over the traditional four-composite model among NHL players. The increased stability in test scores improves the test's ability to detect cognitive changes following injury, which increases the diagnostic utility of the test and allows for better return to play decision-making by reducing the risk of exposing an athlete to additional trauma while the brain may be at a heightened vulnerability to such trauma. Although the Speed Index increases the clinical utility of the test, the stability of the Memory index remains low. Irrespective of whether the two-factor or traditional four-composite approach is used, these data suggest that new baselines should occur on a yearly basis in order to maximize clinical utility.

Stability and local toxicity evaluation of a liposomal prilocaine formulation.

PubMed

Cereda, Cintia M Saia; Tófoli, Giovana R; de Brito Junior, Rui B; de Jesus, Marcelo B; Fraceto, Leonardo F; Groppo, Francisco C; de Araujo, Daniele R; de Paula, Eneida

2008-01-01

This study reports a physicochemical stability evaluation of a previously reported liposomal prilocaine (PLC(LUV)) formulation (Cereda et al. J. Pharm. Pharmaceut. Sci. 7:235, 2004) before and after steam sterilization as well as its local toxicity evaluation. Prilocaine (PLC) was encapsulated into extruded unilamellar liposomes (LUVs) composed by egg phosphatidylcholine:cholesterol:alfa-tocopherol (4:3:0.07, mole %). Laser light-scattering analysis (p > 0.05) and thiobarbituric acid reaction (p > 0.05) were used to evaluate the liposomes physical (size) and chemical (oxidation) stability, respectively. The prilocaine chemical stability was followed by (1)H-nuclear magnetic resonance. These tests detected no differences on the physicochemical stability of PLC or PLC(LUV), sterilized or not, up to 30 days after preparation (p > 0.05). Finally, the paw edema test and histological analysis of rat oral mucosa were used to assess the possible inflammatory effects of PLC(LUV). PLC(LUV) did not evoke rat paw edema (p > 0.05), and no significant differences were found in histological analysis, when compared to the control groups (p > 0.05). The present work shows that PLC(LUV) is stable for a 30-day period and did not induce significant inflammatory effects both in the paw edema test and in histological analysis, giving supporting evidence for its safety and possible clinical use in dentistry.

Biomechanical analysis of intramedullary vs. superior plate fixation of transverse midshaft clavicle fractures.

PubMed

Wilson, David J; Scully, William F; Min, Kyong S; Harmon, Tess A; Eichinger, Josef K; Arrington, Edward D

2016-06-01

Middle-third clavicle fractures represent 2% to 4% of all skeletal trauma in the United States. Treatment options include intramedullary (IM) as well as plate and screw (PS) constructs. The purpose of this study was to analyze the biomechanical stability of a specific IM system compared with nonlocking PS fixation under low-threshold physiologic load. Twenty fourth-generation Sawbones (Pacific Research Laboratories, Vashon, WA, USA) with a simulated middle-third fracture pattern were repaired with either an IM device (n = 10) or superiorly positioned nonlocking PS construct (n = 10). Loads were modeled to simulate physiologic load. Combined axial compression and torsion forces were sequentially increased until failure. Data were analyzed on the basis of loss of rotational stability using 3 criteria: early (10°), clinical (30°), and terminal (120°). No significant difference was noted between constructs in early loss of rotational stability (P > .05). The PS group was significantly more rotationally stable than the IM group on the basis of clinical and terminal criteria (P < .05 for both). All test constructs failed in rotational stability. When tested under physiologic load, fixation failure occurred from loss of rotational stability. No statistical difference was seen between groups under early physiologic loads. However, during load to failure, the PS group was statistically more rotationally stable than the IM group. Given the clavicle's function as a bony strut for the upper extremity and the biomechanical results demonstrated, rotational stability should be carefully considered during surgical planning and postoperative advancement of activity in patients undergoing operative fixation of middle-third clavicle fractures. Basic Science Study; Biomechanics. Published by Elsevier Inc.

Novel implant design improves implant survival in multirooted extraction sites: a preclinical pilot study.

PubMed

Sivan-Gildor, Adi; Machtei, Eli E; Gabay, Eran; Frankenthal, Shai; Levin, Liran; Suzuki, Marcelo; Coelho, Paulo G; Zigdon-Giladi, Hadar

2014-10-01

The primary aim is to evaluate clinical, radiographic, and histologic parameters of novel implants with "three roots" design that were inserted into fresh multirooted extraction sockets. A secondary aim is to compare this new implant to standard root-form dental implants. Immediate implantation of novel or standard design 6 × 6-mm implants was performed bilaterally into multirooted sockets in mandibles of mini-pigs. Twelve weeks later, clinical, radiographic, stability, histomorphometric, and microcomputed tomography (micro-CT) analyses were performed. Survival rates were significantly higher in the test implants compared with control (92.8% versus 33.3%, respectively; P <0.001). Bone loss was greater in the control compared with the test by sounding (mean 3.42 ± 0.68 versus 1.96 ± 0.34 mm) and radiography (mean 3.35 ± 0.62 versus 2.27 ± 0.33 mm). Histologic and micro-CT analyses demonstrated bone fill in the inner part of the test implants. Moreover, bone-to-implant contact was higher in the test implants (55.50% ± 3.68% versus 42.47% ± 9.89%). Contrary to the clinical, radiographic, and histomorphometric results, resonance frequency analysis measurements were greater in the control group (77.74 ± 3.21 implant stability quotient [ISQ]) compared with the test group (31.09 ± 0.28 ISQ), P = 0.008. The novel design implants resulted in significantly greater survival rate in multirooted extraction sites. Further studies will be required to validate these findings.

Clinical variables related to antidepressant-induced mania in bipolar disorder.

PubMed

Mundo, Emanuela; Cattaneo, Elisabetta; Russo, Michela; Altamura, A Carlo

2006-06-01

The development of mania or hypomania during antidepressant treatment is a serious complication of the clinical management of bipolar disorder (BP). The primary aim of this study was to evaluate the clinical variables related to antidepressant-induced mania or hypomania (AIM) in patients with BP. DSM-IV BP-I or BP-II patients who had had at least one depressive episode treated with antidepressants were considered. Patients were subdivided into two groups according to the presence (n = 30) or absence (n = 106) of manic or hypomanic episodes occurring during antidepressant treatment. Possible predictive clinical variables of AIM were considered: gender, diagnostic subtype, age at onset, duration of illness, duration of untreated illness, type of antidepressant administered, number of previous spontaneous hypomanic or manic episodes, number of previous depressive episodes, presence of lifetime suicide attempts, presence of mood stabilizer treatments, presence of psychotic symptoms during spontaneous episodes, family history for psychiatric disorders in first degree relatives. Data were compared between the two groups, with (AIM+) and without (AIM-) antidepressant-induced mania, using Student's t tests and chi-square tests. The lack of mood stabilizer treatments during antidepressant therapy (chi-square = 37.602, df = 1, p < 0.001) and the exposure to tricyclic antidepressants (chi-square = 4.901, df = 1, p < 0.05) resulted significantly associated to the development of AIM. This study was not done under controlled conditions and the relatively small sample studied warrants further replications. These results point out the risk of mania induction associated to the use of tricyclic antidepressants in BP patients, mainly in absence of adequate mood stabilizers.

42 CFR 493.1423 - Standard; Testing personnel qualifications.

Code of Federal Regulations, 2010 CFR

2010-10-01

..., or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical... stability and storage; (F) The skills required to implement the quality control policies and procedures of... HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Personnel for Nonwaived...

Three-dimensional evaluation of postural stability in Parkinson's disease with mobile technology.

PubMed

Ozinga, Sarah J; Koop, Mandy Miller; Linder, Susan M; Machado, Andre G; Dey, Tanujit; Alberts, Jay L

2017-01-01

Postural instability is a hallmark of Parkinson's disease. Objective metrics to characterize postural stability are necessary for the development of treatment algorithms to aid in the clinical setting. The aim of this project was to validate a mobile device platform and resultant three-dimensional balance metric that characterizes postural stability. A mobile Application was developed, in which biomechanical data from inertial sensors within a mobile device were processed to characterize movement of center of mass in the medial-lateral, anterior-posterior and trunk rotation directions. Twenty-seven individuals with Parkinson's disease and 27 age-matched controls completed various balance tasks. A postural stability metric quantifying the amplitude (peak-to-peak) of sway acceleration in each movement direction was compared between groups. The peak-to-peak value in each direction for each individual with Parkinson's disease across all trials was expressed as a normalized value of the control data to identify individuals with severe postural instability, termed Cleveland Clinic-Postural Stability Index. In all conditions, the balance metric for peak-to-peak was significantly greater in Parkinson's disease compared to controls (p < 0.01 for all tests). The balance metric, in conjunction with mobile device sensors, provides a rapid and systematic metric for quantifying postural stability in Parkinson's disease.

A 10-Year Prospective Trial of a Patient Management Algorithm and Screening Examination for Highly Active Individuals with ACL Injury. Part II: Determinants of Dynamic Knee Stability

PubMed Central

Hurd, Wendy J.; Axe, Michael J.; Snyder-Mackler, Lynn

2010-01-01

Objectives To clarify the determinants of dynamic knee stability early after anterior cruciate ligament (ACL) injury. Materials and Methods 345 consecutive patients who were regular participants in IKDC level I/II sports before injury and had an acute isolated ACL injury from the practice of a single orthopaedic surgeon underwent a screening examination including clinical measures, knee laxity, quadriceps strength, hop testing, and patient self-reported knee function an average of 6 weeks after injury when impairments were resolved. Independent t-tests were performed to evaluate differences in quadriceps strength and anterior knee laxity between potential copers and noncopers. Hierarchical regression was performed to determine the influence of quadriceps strength, pre-injury activity level, and anterior knee laxity on hop test performance, as well as the influence of timed hop, cross-over hop, quadriceps strength, pre-injury activity level, and anterior knee laxity on self-assessed global function. Results Neither anterior knee laxity nor quadriceps strength differed between potential copers and non-copers. Quadriceps strength influenced hop test performance more significantly than pre-injury activity level or anterior knee laxity, but the variance accounted for by quadriceps strength was low (Range: 4-8%). Timed hop performance was the only variable that impacted self-assessed global function. Conclusions Traditional surgical decision making based on passive anterior knee laxity and pre-injury activity level is not supported by the results, as neither are good predictors of dynamic knee stability. Clinical tests that capture neuromuscular adaptations, including the timed hop test, may be useful in predicting function and guiding individualized patient management after ACL injury. PMID:17932399

Role of Assessment Tests in the Stability of Intelligence Scoring of Pre-School Children with Uneven/Delayed Cognitive Profile

ERIC Educational Resources Information Center

Yang, P.; Jong, Y-J.; Hsu, H-Y.; Lung, F-W.

2011-01-01

Background: As part of an ongoing clinical service programme for pre-school children with developmental delay in an Asian developing country, we analysed the effect of three assessment tests, that is, Bayley Scale of Infant Development-II, Leiter International Performance Scale-Revised and Wechsler Preschool and Primary Scale of…

Surface microstructure and in vitro analysis of nanostructured akermanite (Ca2MgSi2O7) coating on biodegradable magnesium alloy for biomedical applications.

PubMed

Razavi, Mehdi; Fathi, Mohammadhossein; Savabi, Omid; Hashemi Beni, Batoul; Vashaee, Daryoosh; Tayebi, Lobat

2014-05-01

Magnesium (Mg) alloys, owing to their biodegradability and good mechanical properties, have potential applications as biodegradable orthopedic implants. However, several poor properties including low corrosion resistance, mechanical stability and cytocompatibility have prevented their clinical application, as these properties may result in the sudden failure of the implants during the bone healing. In this research, nanostructured akermanite (Ca2MgSi2O7) powder was coated on the AZ91 Mg alloy through electrophoretic deposition (EPD) assisted micro arc oxidation (MAO) method to modify the properties of the alloy. The surface microstructure of coating, corrosion resistance, mechanical stability and cytocompatibility of the samples were characterized with different techniques including X-ray diffraction (XRD), scanning electron microscopy (SEM), transmission electron microscopy (TEM), electrochemical corrosion test, immersion test, compression test and cell culture test. The results showed that the nanostructured akermanite coating can improve the corrosion resistance, mechanical stability and cytocompatibility of the biodegradable Mg alloy making it a promising material to be used as biodegradable bone implants for orthopedic applications. Published by Elsevier B.V.

Comparative study of a novel application of automated HR HPV assay and stability in a previously untested Preservative media.

PubMed

Morel, Mike E; McBride, Simon E; Gomez, Maria P

2017-12-01

The suitability and stability of cervical cells in Novaprep media (NHQ) for certain HPV assays is unknown. We evaluated the accuracy of an automated HPV assay (Abbott RealTime HR HPV) for cervical cells prepared in NHQ and NHQ with a pre-treatment to mimic a worst case clinical use, compared to the assay manufacturers media; repeatability and reproducibility of HPV results and the stability of detectable HPV in NHQ over time compared to CE marked liquid based cytology preservatives. Cell lines were used to simulate patient samples. Cells stored in NHQ produced accurate, repeatable and reproducible results. Stability in NHQ was comparable to the best performing LBC, with at least 7 months' stability at 18-25°C, 2-8°C, -20°C and -80°C; and at least 3 months' stability at 40°C. Similar results were obtained for pre-treated NHQ except only 3.5 months' stability at 18-25°C. Cell line samples in all media and concentrations tested were detected appropriately by the assay. Based on this first stage validation analytical study, cervical cells stored in NHQ are suitable for the Realtime HPV assay. There should be no reservations for inclusion of NHQ in any further validation and clinical performance evaluation of this assay. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

A novel method to assess primary stability of press-fit acetabular cups.

PubMed

Crosnier, Emilie A; Keogh, Patrick S; Miles, Anthony W

2014-11-01

Initial stability is an essential prerequisite to achieve osseointegration of press-fit acetabular cups in total hip replacements. Most in vitro methods that assess cup stability do not reproduce physiological loading conditions and use simplified acetabular models with a spherical cavity. The aim of this study was to investigate the effect of bone density and acetabular geometry on cup stability using a novel method for measuring acetabular cup micromotion. A press-fit cup was inserted into Sawbones(®) foam blocks having different densities to simulate normal and osteoporotic bone variations and different acetabular geometries. The stability of the cup was assessed in two ways: (a) measurement of micromotion of the cup in 6 degrees of freedom under physiological loading and (b) uniaxial push-out tests. The results indicate that changes in bone substrate density and acetabular geometry affect the stability of press-fit acetabular cups. They also suggest that cups implanted into weaker, for example, osteoporotic, bone are subjected to higher levels of micromotion and are therefore more prone to loosening. The decrease in stability of the cup in the physiological model suggests that using simplified spherical cavities to model the acetabulum over-estimates the initial stability of press-fit cups. This novel testing method should provide the basis for a more representative protocol for future pre-clinical evaluation of new acetabular cup designs. © IMechE 2014.

Influence of Prosthetic Screw Material on Joint Stability in Passive and Non-Passive Implant-Supported Dentures

PubMed Central

Spazzin, Aloísio Oro; Henriques, Guilherme Elias Pessanha; de Arruda Nóbilo, Mauro Antônio; Consani, Rafael Leonardo Xediek; Correr-Sobrinho, Lourenço; Mesquita, Marcelo Ferraz

2009-01-01

Objectives: This study evaluated the influence of prosthetic screw material on joint stability in implantsupported dentures at two levels of fit. Methods: Ten mandibular implant-supported dentures were fabricated. Twenty cast models were fabricated using these dentures. Four groups (n=10) were tested, according to the vertical fit of the dentures [passive and non-passive] and prosthetic screw materials [titanium (Ti) or gold (Au) alloy]. The one-screw test was performed to quantify the vertical misfits using an optic microscope. The loosening torque for the prosthetic screws was measured 24 hours after the tightening torque (10 Ncm) using a digital torque meter. Data were analyzed by two-way ANOVA and Tukey’s test (α=0.05). Results: Overall, dentures with passive fit and Ti screws resulted in significantly higher loosening torque of the prosthetic screws (p<0.05). No significant interaction was found between fit level and screw material (p=0.199). The prosthetic screw material and fit of implant-supported dentures have an influence on screw joint stability. Ti screws presented higher joint stability than Au screws and minimum of misfit should be found clinically to improve the mechanical behavior of the screw joint. PMID:20148135

PET Imaging Stability Measurements During Simultaneous Pulsing of Aggressive MR Sequences on the SIGNA PET/MR System.

PubMed

Deller, Timothy W; Khalighi, Mohammad Mehdi; Jansen, Floris P; Glover, Gary H

2018-01-01

The recent introduction of simultaneous whole-body PET/MR scanners has enabled new research taking advantage of the complementary information obtainable with PET and MRI. One such application is kinetic modeling, which requires high levels of PET quantitative stability. To accomplish the required PET stability levels, the PET subsystem must be sufficiently isolated from the effects of MR activity. Performance measurements have previously been published, demonstrating sufficient PET stability in the presence of MR pulsing for typical clinical use; however, PET stability during radiofrequency (RF)-intensive and gradient-intensive sequences has not previously been evaluated for a clinical whole-body scanner. In this work, PET stability of the GE SIGNA PET/MR was examined during simultaneous scanning of aggressive MR pulse sequences. Methods: PET performance tests were acquired with MR idle and during simultaneous MR pulsing. Recent system improvements mitigating RF interference and gain variation were used. A fast recovery fast spin echo MR sequence was selected for high RF power, and an echo planar imaging sequence was selected for its high heat-inducing gradients. Measurements were performed to determine PET stability under varying MR conditions using the following metrics: sensitivity, scatter fraction, contrast recovery, uniformity, count rate performance, and image quantitation. A final PET quantitative stability assessment for simultaneous PET scanning during functional MRI studies was performed with a spiral in-and-out gradient echo sequence. Results: Quantitation stability of a 68 Ge flood phantom was demonstrated within 0.34%. Normalized sensitivity was stable during simultaneous scanning within 0.3%. Scatter fraction measured with a 68 Ge line source in the scatter phantom was stable within the range of 40.4%-40.6%. Contrast recovery and uniformity were comparable for PET images acquired simultaneously with multiple MR conditions. Peak noise equivalent count rate was 224 kcps at an effective activity concentration of 18.6 kBq/mL, and the count rate curves and scatter fraction curve were consistent for the alternating MR pulsing states. A final test demonstrated quantitative stability during a spiral functional MRI sequence. Conclusion: PET stability metrics demonstrated that PET quantitation was not affected during simultaneous aggressive MRI. This stability enables demanding applications such as kinetic modeling. © 2018 by the Society of Nuclear Medicine and Molecular Imaging.

A thermodynamic assay to test pharmacological chaperones for Fabry disease.

PubMed

Andreotti, Giuseppina; Citro, Valentina; Correra, Antonella; Cubellis, Maria Vittoria

2014-03-01

The majority of the disease-causing mutations affect protein stability, but not functional sites and are amenable, in principle, to be treated with pharmacological chaperones. These drugs enhance the thermodynamic stability of their targets. Fabry disease, a disorder caused by mutations in the gene encoding lysosomal alpha-galactosidase, represents an excellent model system to develop experimental protocols to test the efficiency of such drugs. The stability of lysosomal alpha-galactosidase under different conditions was studied by urea-induced unfolding followed by limited proteolysis and Western blotting. We measured the concentration of urea needed to obtain half-maximal unfolding because this parameter represents an objective indicator of protein stability. Urea-induced unfolding is a versatile technique that can be adapted to cell extracts containing tiny amounts of wild-type or mutant proteins. It allows testing of protein stability as a function of pH, in the presence or in the absence of drugs. Results are not influenced by the method used to express the protein in transfected cells. Scarce and dispersed populations pose a problem for the clinical trial of drugs for rare diseases. This is particularly true for pharmacological chaperones that must be tested on each mutation associated with a given disease. Diverse in vitro tests are needed. We used a method based on chemically induced unfolding as a tool to assess whether a particular Fabry mutation is responsive to pharmacological chaperones, but, by no means is our protocol limited to this disease. Copyright © 2013 The Authors. Published by Elsevier B.V. All rights reserved.

Stability of plasma electrolytes in Barricor and PST II tubes under different storage conditions.

PubMed

Balbás, Luis Alfredo Bautista; Amaro, Marta Segovia; Rioja, Rubén Gómez; Martín, María José Alcaide; Soto, Antonio Buńo

2017-02-15

Sample stability can be influenced by many different factors; evaporation and leakage from residual cells are the most relevant factors for electrolytes. During the analytical phase, samples are usually kept uncapped at room temperature. Once samples are processed, they are usually stored sealed and refrigerated. Long turnaround time and the possibility of "add-on test" need consideration for electrolyte stability. The aim of our study is to examine short-term electrolyte stability in this two-common laboratory working conditions in two different lithium heparin plasma tubes (Barricor and PST II, Becton Dickinson). In 39 plasma samples from voluntary subjects we measured sodium (Na + ), potassium (K + ) and chloride (Cl - ) at 6 time points since centrifugation (0h, 3h, 6h, 9h, 12h and 15h). Maximum allowable bias (clinically significant change) was based in SEQC (Sociedad Espańola de Química Clínica) recommendations; 1% for Cl - , 0.6% for Na + and 4% for K + . In open room temperature tubes, clinically significant changes appeared in Na + and Cl - after 3 hours and in K + after 9 hours in both types of tubes. In refrigerated sealed tubes, all the analytes were clinically stable up to 12 hours in both kinds of plasma tubes. We observed a statistically significant progressive increase in K + levels, which was less pronounced in Barricor tubes. Stability of electrolytes is compromised after 3 hours in open tubes and after 12 hours in sealed tubes.

Two baselines are better than one: Improving the reliability of computerized testing in sports neuropsychology.

PubMed

Bruce, Jared; Echemendia, Ruben; Tangeman, Lindy; Meeuwisse, Willem; Comper, Paul; Hutchison, Michael; Aubry, Mark

2016-01-01

Computerized neuropsychological tests are frequently used to assist in return-to-play decisions following sports concussion. However, due to concerns about test reliability, the Centers for Disease Control and Prevention recommends yearly baseline testing. The standard practice that has developed in baseline/postinjury comparisons is to examine the difference between the most recent baseline test and postconcussion performance. Drawing from classical test theory, the present study investigated whether temporal stability could be improved by taking an alternate approach that uses the aggregate of 2 baselines to more accurately estimate baseline cognitive ability. One hundred fifteen English-speaking professional hockey players with 3 consecutive Immediate Postconcussion Assessment and Testing (ImPACT) baseline tests were extracted from a clinical program evaluation database overseen by the National Hockey League and National Hockey League Players' Association. The temporal stability of ImPACT composite scores was significantly increased by aggregating test performance during Sessions 1 and 2 to predict performance during Session 3. Using this approach, the 2-factor Memory (r = .72) and Speed (r = .79) composites of ImPACT showed acceptable long-term reliability. Using the aggregate of 2 baseline scores significantly improves temporal stability and allows for more accurate predictions of cognitive change following concussion. Clinicians are encouraged to estimate baseline abilities by taking into account all of an athlete's previous baseline scores.

Intelligent walkers for the elderly: performance and safety testing of VA-PAMAID robotic walker.

PubMed

Rentschler, Andrew J; Cooper, Rory A; Blasch, Bruce; Boninger, Michael L

2003-01-01

A walker that could help navigate and avoid collisions with obstacles could help reduce health costs and increase the quality of care and independence of thousands of people. This study evaluated the safety and performance of the Veterans Affairs Personal Adaptive Mobility Aid (VA-PAMAID). We performed engineering tests on the VA-PAMAID to determine safety factors, including stability, energy consumption, fatigue life, and sensor and control malfunctions. The VA-PAMAID traveled 10.9 km on a full charge and avoided obstacles while traveling at a speed of up to 1.2 m/s. No failures occurred during static stability, climatic, or fatigue testing. Some problems were encountered during obstacle climbing and sensor and control testing. The VA-PAMAID has good range, has adequate reaction time, and is structurally sound. Clinical trials are planned to compare the device to other low-technical adaptive mobility devices.

Impaired limb reaction to displacement of center of gravity in rats with unilateral striatal ischemic injury.

PubMed

Nobile, Cameron W; Palmateer, Julie M; Kane, Jackie; Hurn, Patricia D; Schallert, Timothy; Adkins, DeAnna L

2014-10-01

Clinical stroke often results in impaired balance and increased vulnerability to severe injuries due to falling. To evaluate potential preclinical treatments that might target these deficits, it will be important to include tests capable of assessing these impairments chronically in animal models. Previously, we developed a postural instability test (PIT) that revealed chronic, unilateral impairments in postural stability in rat models of hemi-Parkinson's disease (PD) and of unilateral cervical spinal cord injury. Here, we investigated whether this test was also capable of revealing long-term stroke-induced impairments in postural support in rats. Additionally, we examined the ability of more common tests of sensorimotor function to detect chronic impairments. We found that the PIT detected chronic deficits in postural stability/balance enduring for up to 6 weeks post-stroke, outlasting impairments detected in other tests of forelimb sensorimotor function, including asymmetries in upright postural support (cylinder test) and vibrissae-evoked forelimb placing.

Facile synthesis of silver nanoparticles mediated by polyacrylamide-reduction approach to antibacterial application.

PubMed

Salaheldin, Hosam I; Almalki, Meshal H K; Hezma, Abd Elhameed M; Osman, Gamal E H

2017-06-01

The current time increase in the prevalence of antibiotic resistant 'super-bugs' and the risks associated with food safety have become global issues. Therefore, further research is warranted to identify new and effective antimicrobial substances. Silver nanoparticles (Ag-NPs) were synthesized by autoclaving technique using, different concentrations of Ag salt (AgNO 3 ) solution (1, 5, 10, and 25 mM). Their presence was confirmed by a surface plasmon resonance band at ∼435 nm using UV-Vis absorption spectra. The morphology of the synthesized Ag-NPs stabilized by polyacrylamide (PAM) was examined by TEM, SAED, and EDS. TEM images revealed that the synthesized Ag-NPs had an average diameter of 2.98±0.08 nm and SAED and EDS results confirmed the formation of Ag-NPs. In addition, FT-IR spectroscopy revealed that a PAM polymer matrix stabilized the Ag-NPs. The well diffusion method, was used to test, Gram positive and Gram negative bacteria were examined. Also the minimal inhibitory concentration (MIC) and minimal bactericidal concentration (MBC) were studied against Ag-NPs. The Ag-NPs exhibited strong inhibitory activity, MIC and MBC against the tested clinical bacterial isolates. These results suggest that Ag-NPs stabilized in PAM are highly effective against clinical bacterial isolates can be applied in medical fields.

Long-term conservation of HCV RNA at 4 degrees C using a new RNA stabilizing solution.

PubMed

Gonzalez-Perez, Idania; Cayarga, Anny Armas; Hernández, Yenitse Perea; de la Rosa, Iria García; González, Yaimé Josefina González; León, Carlos Silva; Alvarez, René Robaina

2010-09-01

Protecting RNA from degradation, whilst maintaining its biological activity, is essential in molecular biology. However, RNA is very sensitive to degradation by ribonucleases, especially at temperatures above 0 degrees C. The stability of RNA was examined at 4 degrees C and -20 degrees C, in a new stabilizing solution consisting of a low-molarity mixture of chaotropic agents guanidinium and ammonium thiocyanate, a buffer for pH stabilization, phenol, and yeast RNA. Two substrates were tested for storage: RNA in human plasma positive for hepatitis C virus (HCV) and naked RNA (purified from HCV positive human plasma or transcribed in vitro). Stability was followed by viral load estimation, using an in-house competitive RT-PCR assay. Naked RNA purified from human plasma positive for HCV was stable at 4 degrees C for at least 24 months. An RNA standard transcribed in vitro was still viable after 36 months of storage at 4 degrees C. Human plasma dilutions positive for HCV were stable for at least 5 months in this solution when stored at 4 degrees C. It was concluded that the described stabilizing solution ensures long-term stability on naked RNA at 4 degrees C, and ideal for the storage of RNA controls and standards for molecular diagnosis, the solution may be used for preserving clinical samples prior to transport to a clinical laboratory. Copyright 2010 Elsevier B.V. All rights reserved.

Satisfaction in complete denture wearers with and without adhesives: A randomized, crossover, double-blind clinical trial

PubMed Central

Torres-Sánchez, Carlos; Montoya-Salazar, Vanessa; Gutierrez-Pérez, Jose-Luis; Jimenez-Castellanos, Emilio

2018-01-01

Background The purpose of this study was to compare the satisfaction of patients regarding retention, stability and accumulation of particles with a randomized, double-blind crossed method in users with complete dentures with and without adhesive. Material and Methods Seventeen edentulous individuals were randomized and received new upper and lower complete dentures. After a period of adaptation, they participated in some masticatory tests and clinical revisions, after use the protheses with and without the use of two denture adhesives: Adhesive A (Fittydent, Fittydent International GmbH) and adhesive B (Corega, GlaxoSmithKline) at 0, 7 and 14 days. Satisfaction was measured immediately after each test through a survey using a VAS scale (0-10) and data were analyzed with McNemar’s test with Bonferroni correction. Results The results showed significant differences (p<.01) between the study groups with adhesive A - B and the group without adhesive, but no significant differences were found between the two stickers for any of the variables studied. Conclusions Complete denture adhesives significantly improved the satisfaction of patients because a better retention, stability and less accumulation of particles of the food substitute between the denture and the mucosa is obtained compared with non-use of complete denture adhesives. Key words:Complete dentures, patient satisfaction, denture adhesives, clinical trials. PMID:29946414

Long-term Stability and Reliability of Baseline Cognitive Assessments in High School Athletes Using ImPACT at 1-, 2-, and 3-year Test-Retest Intervals.

PubMed

Brett, Benjamin L; Smyk, Nathan; Solomon, Gary; Baughman, Brandon C; Schatz, Philip

2016-08-18

The ImPACT (Immediate Post-Concussion Assessment and Cognitive Testing) neurocognitive testing battery is a widely used tool used for the assessment and management of sports-related concussion. Research on the stability of ImPACT in high school athletes at a 1- and 2-year intervals have been inconsistent, requiring further investigation. We documented 1-, 2-, and 3-year test-retest reliability of repeated ImPACT baseline assessments in a sample of high school athletes, using multiple statistical methods for examining stability. A total of 1,510 high school athletes completed baseline cognitive testing using online ImPACT test battery at three time periods of approximately 1- (N = 250), 2- (N = 1146), and 3-year (N = 114) intervals. No participant sustained a concussion between assessments. Intraclass correlation coefficients (ICCs) ranged in composite scores from 0.36 to 0.90 and showed little change as intervals between assessments increased. Reliable change indices and regression-based measures (RBMs) examining the test-retest stability demonstrated a lack of significant change in composite scores across the various time intervals, with very few cases (0%-6%) falling outside of 95% confidence intervals. The results suggest ImPACT composites scores remain considerably stability across 1-, 2-, and 3-year test-retest intervals in high school athletes, when considering both ICCs and RBM. Annually ascertaining baseline scores continues to be optimal for ensuring accurate and individualized management of injury for concussed athletes. For instances in which more recent baselines are not available (1-2 years), clinicians should seek to utilize more conservative range estimates in determining the presence of clinically meaningful change in cognitive performance. © The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Recovery and Stability of Δ9-Tetrahydrocannabinol Using the Oral-Eze® Oral Fluid Collection System and Intercept® Oral Specimen Collection Device.

PubMed

Samano, Kimberly L; Anne, Lakshmi; Johnson, Ted; Tang, Kenneth; Sample, R H Barry

2015-10-01

Oral fluid (OF) is increasingly used for clinical, forensic and workplace drug testing as an alternative to urine. Uncertainties surrounding OF collection device performance, drug stability and testing reproducibility may be partially responsible for delays in the implementation of OF testing in regulated drug testing programs. Stability of Δ(9)-tetrahydrocannabinol (THC) fortified and authentic specimens was examined after routine collection, transport and laboratory testing. Acceptable recovery and stability were observed when THC-fortified OF (1.5 and 4.5 ng/mL) was applied to Oral-Eze devices. Neat OF samples collected with Oral-Eze, processed per the package insert, and fortified with THC (3 and 6 ng/mL) were stable (±20%) at room temperature (21-25°C), refrigerated (2-8°C) and frozen (-25 to -15°C) conditions up to 1 month, while samples collected with Intercept devices showed decreases at refrigerated and room temperatures. After long-term refrigerated or frozen storage, maximum reductions in THC concentrations were 42% for Oral-Eze and 69% for Intercept. After ≥1 year frozen storage, 80.7% of laboratory specimens positive for THC (3 ng/mL cut-off) by GC-MS were reconfirmed positive (within 25%), with an average THC decrease of 4.2%. Specimens (n = 47) processed with Oral-Eze (diluted) and tested via enzyme immunoassay were concordant with LC-MS-MS results and showed 100% sensitivity and 95% specificity. Paired specimens collected with Oral-Eze and Intercept exhibited 98% overall agreement between the immunoassay test systems. Collectively, these data demonstrate consistent and reproducible recovery and stability of THC in OF after collection, transport and laboratory testing using the Oral-Eze OF Collection System. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Prospective, Head-to-Head Study of Three Computerized Neurocognitive Assessment Tools (CNTs): Reliability and Validity for the Assessment of Sport-Related Concussion.

PubMed

Nelson, Lindsay D; LaRoche, Ashley A; Pfaller, Adam Y; Lerner, E Brooke; Hammeke, Thomas A; Randolph, Christopher; Barr, William B; Guskiewicz, Kevin; McCrea, Michael A

2016-01-01

Limited data exist comparing the performance of computerized neurocognitive tests (CNTs) for assessing sport-related concussion. We evaluated the reliability and validity of three CNTs-ANAM, Axon Sports/Cogstate Sport, and ImPACT-in a common sample. High school and collegiate athletes completed two CNTs each at baseline. Concussed (n=165) and matched non-injured control (n=166) subjects repeated testing within 24 hr and at 8, 15, and 45 days post-injury. Roughly a quarter of each CNT's indices had stability coefficients (M=198 day interval) over .70. Group differences in performance were mostly moderate to large at 24 hr and small by day 8. The sensitivity of reliable change indices (RCIs) was best at 24 hr (67.8%, 60.3%, and 47.6% with one or more significant RCIs for ImPACT, Axon, and ANAM, respectively) but diminished to near the false positive rates thereafter. Across time, the CNTs' sensitivities were highest in those athletes who became asymptomatic within 1 day before neurocognitive testing but was similar to the tests' false positive rates when including athletes who became asymptomatic several days earlier. Test-retest reliability was similar among these three CNTs and below optimal standards for clinical use on many subtests. Analyses of group effect sizes, discrimination, and sensitivity and specificity suggested that the CNTs may add incrementally (beyond symptom scores) to the identification of clinical impairment within 24 hr of injury or within a short time period after symptom resolution but do not add significant value over symptom assessment later. The rapid clinical recovery course from concussion and modest stability probably jointly contribute to limited signal detection capabilities of neurocognitive tests outside a brief post-injury window. (JINS, 2016, 22, 24-37).

Clinical Assessment and Diagnostics of Patients With Hand Disorders: A Case Study Approach.

PubMed

Leow, Mabel Qi He; Lim, Rebecca Qian Ru; Tay, Shian Chao

Clinical assessment of the hand is important for diagnosing underlying hand disorders. Using a case study approach, the clinical assessment for three disorders of the hands is presented: trigger finger (stenosing tenosynovitis), carpal tunnel syndrome, and ulnar-sided wrist injury (styloid impingement). We assess the annular one pulley and finger range of motion for patients with trigger finger. To diagnose for carpal tunnel syndrome, assessment for Tinel's sign, Phalen's sign, abductor pollicis brevis muscle bulk, two-point discrimination, and obtaining a nerve conduction study are performed. Assessment for ulnar-sided wrist injury includes wrist range of motion, assessment of distal radial ulnar joint stability, provocation tests, grip strength, x-ray, and magnetic resonance imaging. This article begins with a description of the hand and wrist anatomy. For each case study, the clinical history is described, followed by a discussion of the pathophysiology, clinical assessments, and diagnostic tests.

Outcomes of Complete Versus Partial Surgical Stabilization of Flail Chest.

PubMed

Nickerson, Terry P; Thiels, Cornelius A; Kim, Brian D; Zielinski, Martin D; Jenkins, Donald H; Schiller, Henry J

2016-01-01

Rib fractures are common after chest wall trauma. For patients with flail chest, surgical stabilization is a promising technique for reducing morbidity. Anatomical difficulties often lead to an inability to completely repair the flail chest; thus, the result is partial flail chest stabilization (PFS). We hypothesized that patients with PFS have outcomes similar to those undergoing complete flail chest stabilization (CFS). A prospectively collected database of all patients who underwent rib fracture stabilization procedures from August 2009 until February 2013 was reviewed. Abstracted data included procedural and complication data, extent of stabilization, and pulmonary function test results. Of 43 patients who underwent operative stabilization of flail chest, 23 (53%) had CFS and 20 (47%) underwent PFS. Anterior location of the fracture was the most common reason for PFS (45%). Age, sex, operative time, pneumonia, intensive care unit and hospital length of stay, and narcotic use were the same in both groups. Total lung capacity was significantly improved in the CFS group at 3 months. No chest wall deformity was appreciated on follow-up, and no patients underwent additional stabilization procedures following PFS. Despite advances in surgical technique, not all fractures are amenable to repair. There was no difference in chest wall deformity, narcotic use, or clinically significant impairment in pulmonary function tests among patients who underwent PFS compared with CFS. Our data suggest that PFS is an acceptable strategy and that extending or creating additional incisions for CFS is unnecessary.

Stability-based classification for ankle fracture management and the syndesmosis injury in ankle fractures due to a supination external rotation mechanism of injury.

PubMed

Pakarinen, Harri

2012-12-01

The aim of this thesis was to confirm the utility of stability-based ankle fracture classification in choosing between non-operative and operative treatment of ankle fractures, to determine how many ankle fractures are amenable to non-operative treatment, to assess the roles of the exploration and anatomical repair of the AITFL in the outcome of patients with SER ankle fractures, to establish the sensitivities, specificities and interobserver reliabilities of the hook and intraoperative stress tests for diagnosing syndesmosis instability in SER ankle fractures, and to determine whether transfixation of unstable syndesmosis is necessary in SER ankle fractures. The utility of stability based fracture classification to choose between non-operative and operative treatment was assessed in a retrospective study (1) of 253 ankle fractures in skeletally mature patients, 160 of whom were included in the study to obtain an epidemiological profile in a population of 130,000. Outcome was assessed after a minimum follow-up of two years. The role of AITFL repairs was assessed in a retrospective study (2) of 288 patients with Lauge-Hansen SE4 ankle fractures; the AITFL was explored and repaired in one group (n=165), and a similar operative method was used but the AITFL was not explored in another group (n=123). Outcome was measured with a minimum follow-up of two years. Interobserver reliability of clinical syndesomosis tests (study 3) and the role of syndesmosis transfixation (study 4) were assessed in a prospective study of 140 patients with Lauge-Hansen SE4 ankle fractures. The stability of the distal tibiofibular joint was evaluated by the hook and ER stress tests. Clinical tests were carried out by the main surgeon and assistant, separately, after which a 7.5-Nm standardized ER stress test for both ankles was performed; if it was positive, the patient was randomized to either syndesmosis transfixation (13 patients) or no fixation (11 patients) treatment groups. The sensitivity and specificity of both clinical tests were calculated using the standard 7.5-Nm external rotation stress test as reference. Outcome was assessed after a minimum of one year of follow-up. Olerud-Molander (OM) scoring system, RAND 36-Item Health Survey, and VAS to measure pain and function were used as outcome measures in all studies. In study 1, 85 (53%) fractures were treated operatively using the stability based fracture classification. Non-operatively treated patients reported less pain and better OM (good or excellent 89% vs. 71%) and VAS functional scores compared to operatively treated patients although they experienced more displacement of the distal fibula (0 mm 30% vs. 69%; 0-2 mm 65% vs. 25%) after treatment. No non-operatively treated patients required operative fracture fixation during follow-up. In study 2, AITFL exploration and suture lead to equal functional outcome (OM mean, 77 vs. 73) to no exploration or fixation. In study 3, the hook test had a sensitivity of 0.25 and a specificity of 0.98. The external rotation stress test had a sensitivity of 0.58 and a specificity of 0.9. Both tests had excellent interobserver reliability; the agreement was 99% for the hook test and 98% for the stress test. There was no statistically significant difference in functional scores (OM mean, 79.6 vs. 83.6) or pain between syndesmosis transfixation and no fixation groups (Study 4). Our results suggest that a simple stability-based fracture classification is useful in choosing between non-operative and operative treatment of ankle fractures; approximately half of the ankle fractures can be treated non-operatively with success. Our observations also suggest that relevant syndesmosis injuries are rare in ankle fractures due to an SER mechanism of injury. According to our research, syndesmotic repair or fixation in SER ankle fracture has no influence on functional outcome or pain after minimum one year compared with no fixation.

Interferences from blood collection tube components on clinical chemistry assays

PubMed Central

Bowen, Raffick A.R.; Remaley, Alan T.

2014-01-01

Improper design or use of blood collection devices can adversely affect the accuracy of laboratory test results. Vascular access devices, such as catheters and needles, exert shear forces during blood flow, which creates a predisposition to cell lysis. Components from blood collection tubes, such as stoppers, lubricants, surfactants, and separator gels, can leach into specimens and/or adsorb analytes from a specimen; special tube additives may also alter analyte stability. Because of these interactions with blood specimens, blood collection devices are a potential source of pre-analytical error in laboratory testing. Accurate laboratory testing requires an understanding of the complex interactions between collection devices and blood specimens. Manufacturers, vendors, and clinical laboratorians must consider the pre-analytical challenges in laboratory testing. Although other authors have described the effects of endogenous substances on clinical assay results, the effects/impact of blood collection tube additives and components have not been well systematically described or explained. This review aims to identify and describe blood collection tube additives and their components and the strategies used to minimize their effects on clinical chemistry assays. PMID:24627713

Gene expression of inflammation and bone healing in peri-implant crevicular fluid after placement and loading of dental implants. A kinetic clinical pilot study using quantitative real-time PCR.

PubMed

Slotte, Christer; Lennerås, Maria; Göthberg, Catharina; Suska, Felicia; Zoric, Neven; Thomsen, Peter; Nannmark, Ulf

2012-10-01

Early detection of healing complications after placement of dental implants is a pressing but elusive goal. This paper proposes a non-invasive diagnostic tool for monitoring healing- and peri-implant disease specific genes, complementary to clinical evaluations. Eighteen partially edentulous patients were recruited to this pilot study. Three Brånemark TiUnite® implants/patient (Nobel Biocare) were placed in a one-stage procedure. Abutments with smooth or rough (TiUnite®) surface were placed. The test group (n = 9) received fixed bridges (immediate loading), whereas the control group (n = 9) implants were loaded 3 months after surgery. In addition to clinical measurements, crevicular fluid was collected using paper strips at the implant abutments 2, 14, 28, and 90 days postoperative. mRNA was extracted, purified, and converted to cDNA. Quantitative PCR assays for IL-1β, TNF-α, Osteocalcin (OC), Alkaline Phosphatase (ALP), Cathepsin K, Tartrate Resistant Acid Phosphatase, and 18S ribosomal RNA were designed and validated. Relative gene expression levels were calculated. One implant was lost in the control group and three in the test group. In one test patient, one implant showed lowered stability after 2 to 4 weeks and was unloaded. Later implant stability improved which allowed for loading after 3 to 4 months. TNF-α and ALP most commonly showed correlation with clinical parameters followed by IL-1β and OC. The strongest correlation was found for TNF-α with clinical complications at 2 and 14 days (p = .01/r = -048, and p = .0004/r = -0.56, respectively; test and control groups together). In some cases, gene expression predicted clinical complications (TNF-α, ALP, CK). This study is based on samples from few individuals; still, some genes showed correlation with clinical findings. Further studies are needed to refine and optimize the sampling process, to find the appropriate panel, and to validate gene expression for monitoring implant healing. © 2010 Wiley Periodicals, Inc.

Does patient-perceived handicap correspond to the modified clinical test for the sensory interaction on balance?

PubMed

Loughran, Sean; Gatehouse, Stuart; Kishore, Ameet; Swan, Iain R C

2006-01-01

To determine whether patient self-reported handicap correlates with scores obtained from the modified Clinical Test for the Sensory Interaction on Balance as assessed by the Neurocom VSR Balance Master platform. Prospective observational. Balance clinic in tertiary referral center. Patients referred with dizziness or imbalance as their primary complaint. The modified Clinical Test for the Sensory Interaction on Balance scores as assessed by the Neurocom VSR Balance Master platform, the Dizziness Handicap Inventory, and the Health Utilities Index Marks 2 and 3. One hundred fifty-nine patients were entered into the study. The mean age of participants was 54.5 years, with a female-to-male ratio of 2.1:1. The scores for the Dizziness Handicap Inventory and Health Utilities Index are similar between sexes, and although the Dizziness Handicap Inventory score did not correlate with age, Health Utilities Index 2 and 3 scores did show a negative correlation with increasing age. There are weak, positive correlations between the Dizziness Handicap Inventory and the firm surface conditions of the modified Clinical Test for the Sensory Interaction on Balance but no useful correlation with the foam conditions. Similar weak negative correlations were found between the Health Utilities Index 2 and 3 and the modified Clinical Test for the Sensory Interaction on Balance scores. Patient-perceived handicap of imbalance appears to correlate poorly with assessment of postural stability using the modified Clinical Test for the Sensory Interaction on Balance.

Characterization of neurophysiologic and neurocognitive biomarkers for use in genomic and clinical outcome studies of schizophrenia.

PubMed

Light, Gregory A; Swerdlow, Neal R; Rissling, Anthony J; Radant, Allen; Sugar, Catherine A; Sprock, Joyce; Pela, Marlena; Geyer, Mark A; Braff, David L

2012-01-01

Endophenotypes are quantitative, laboratory-based measures representing intermediate links in the pathways between genetic variation and the clinical expression of a disorder. Ideal endophenotypes exhibit deficits in patients, are stable over time and across shifts in psychopathology, and are suitable for repeat testing. Unfortunately, many leading candidate endophenotypes in schizophrenia have not been fully characterized simultaneously in large cohorts of patients and controls across these properties. The objectives of this study were to characterize the extent to which widely-used neurophysiological and neurocognitive endophenotypes are: 1) associated with schizophrenia, 2) stable over time, independent of state-related changes, and 3) free of potential practice/maturation or differential attrition effects in schizophrenia patients (SZ) and nonpsychiatric comparison subjects (NCS). Stability of clinical and functional measures was also assessed. Participants (SZ n = 341; NCS n = 205) completed a battery of neurophysiological (MMN, P3a, P50 and N100 indices, PPI, startle habituation, antisaccade), neurocognitive (WRAT-3 Reading, LNS-forward, LNS-reorder, WCST-64, CVLT-II). In addition, patients were rated on clinical symptom severity as well as functional capacity and status measures (GAF, UPSA, SOF). 223 subjects (SZ n = 163; NCS n = 58) returned for retesting after 1 year. Most neurophysiological and neurocognitive measures exhibited medium-to-large deficits in schizophrenia, moderate-to-substantial stability across the retest interval, and were independent of fluctuations in clinical status. Clinical symptoms and functional measures also exhibited substantial stability. A Longitudinal Endophenotype Ranking System (LERS) was created to rank neurophysiological and neurocognitive biomarkers according to their effect sizes across endophenotype criteria. The majority of neurophysiological and neurocognitive measures exhibited deficits in patients, stability over a 1-year interval and did not demonstrate practice or time effects supporting their use as endophenotypes in neural substrate and genomic studies. These measures hold promise for informing the "gene-to-phene gap" in schizophrenia research.

Characterization of Neurophysiologic and Neurocognitive Biomarkers for Use in Genomic and Clinical Outcome Studies of Schizophrenia

PubMed Central

Light, Gregory A.; Swerdlow, Neal R.; Rissling, Anthony J.; Radant, Allen; Sugar, Catherine A.; Sprock, Joyce; Pela, Marlena; Geyer, Mark A.; Braff, David L.

2012-01-01

Background Endophenotypes are quantitative, laboratory-based measures representing intermediate links in the pathways between genetic variation and the clinical expression of a disorder. Ideal endophenotypes exhibit deficits in patients, are stable over time and across shifts in psychopathology, and are suitable for repeat testing. Unfortunately, many leading candidate endophenotypes in schizophrenia have not been fully characterized simultaneously in large cohorts of patients and controls across these properties. The objectives of this study were to characterize the extent to which widely-used neurophysiological and neurocognitive endophenotypes are: 1) associated with schizophrenia, 2) stable over time, independent of state-related changes, and 3) free of potential practice/maturation or differential attrition effects in schizophrenia patients (SZ) and nonpsychiatric comparison subjects (NCS). Stability of clinical and functional measures was also assessed. Methods Participants (SZ n = 341; NCS n = 205) completed a battery of neurophysiological (MMN, P3a, P50 and N100 indices, PPI, startle habituation, antisaccade), neurocognitive (WRAT-3 Reading, LNS-forward, LNS-reorder, WCST-64, CVLT-II). In addition, patients were rated on clinical symptom severity as well as functional capacity and status measures (GAF, UPSA, SOF). 223 subjects (SZ n = 163; NCS n = 58) returned for retesting after 1 year. Results Most neurophysiological and neurocognitive measures exhibited medium-to-large deficits in schizophrenia, moderate-to-substantial stability across the retest interval, and were independent of fluctuations in clinical status. Clinical symptoms and functional measures also exhibited substantial stability. A Longitudinal Endophenotype Ranking System (LERS) was created to rank neurophysiological and neurocognitive biomarkers according to their effect sizes across endophenotype criteria. Conclusions The majority of neurophysiological and neurocognitive measures exhibited deficits in patients, stability over a 1-year interval and did not demonstrate practice or time effects supporting their use as endophenotypes in neural substrate and genomic studies. These measures hold promise for informing the “gene-to-phene gap” in schizophrenia research. PMID:22802938

An investigation into the stability and sterility of citric acid solutions used for cough reflex testing.

PubMed

Falconer, James R; Wu, Zimei; Lau, Hugo; Suen, Joanna; Wang, Lucy; Pottinger, Sarah; Lee, Elaine; Alazawi, Nawar; Kallesen, Molly; Gargiulo, Derryn A; Swift, Simon; Svirskis, Darren

2014-10-01

Citric acid is used in cough reflex testing in clinical and research settings to assess reflexive cough in patients at risk of swallowing disorders. To address a lack of knowledge in this area, this study investigated the stability and sterility of citric acid solutions. Triplicate solutions of citric acid (0.8 M) in isotonic saline were stored at 4 ± 2 °C for up to 28 days and analysed by high-performance liquid chromatography. Microbiological sterility of freshly prepared samples and bulk samples previously used for 2 weeks within the hospital was determined using a pour plate technique. Microbial survival in citric acid was determined by inoculating Staphylococcus aureus, Escherichia coli, or Candida albicans into citric acid solution and monitoring the number of colony-forming units/mL over 40 min. Citric acid solutions remained stable at 4 °C for 28 days (98.4 ± 1.8 % remained). The freshly prepared and clinical samples tested were sterile. However, viability studies revealed that citric acid solution allows for the survival of C. albicans but not for S. aureus or E. coli. The microbial survival study showed that citric acid kills S. aureus and E. coli but has no marked effect on C. albicans after 40 min. Citric acid samples at 0.8 M remained stable over the 4-week testing period, with viable microbial cells absent from samples tested. However, C. albicans has the ability to survive in citric acid solution if inadvertently introduced in practice. For this reason, in clinical and research practice it is suggested to use single-use aliquots prepared aseptically which can be stored for up to 28 days at 4 °C.

Prospective, Head-to-Head Study of Three Computerized Neurocognitive Assessment Tools (CNTs): Reliability and Validity for the Assessment of Sport-Related Concussion

PubMed Central

Nelson, Lindsay D.; LaRoche, Ashley A.; Pfaller, Adam Y.; Lerner, E. Brooke; Hammeke, Thomas A.; Randolph, Christopher; Barr, William B.; Guskiewicz, Kevin; McCrea, Michael A.

2016-01-01

Limited data exist comparing the performance of computerized neurocognitive tests (CNTs) for assessing sport-related concussion. We evaluated the reliability and validity of three CNTs—ANAM, Axon Sports/Cogstate Sport, and ImPACT—in a common sample. High school and collegiate athletes completed two CNTs each at baseline. Concussed (n = 165) and matched non-injured control (n = 166) subjects repeated testing within 24 hr and at 8, 15, and 45 days post-injury. Roughly a quarter of each CNT's indices had stability coefficients (M = 198 day interval) over .70. Group differences in performance were mostly moderate to large at 24 hr and small by day 8. The sensitivity of reliable change indices (RCIs) was best at 24 hr (67.8%, 60.3%, and 47.6% with one or more significant RCIs for ImPACT, Axon, and ANAM, respectively) but diminished to near the false positive rates thereafter. Across time, the CNTs' sensitivities were highest in those athletes who became asymptomatic within 1 day before neurocognitive testing but was similar to the tests' false positive rates when including athletes who became asymptomatic several days earlier. Test–retest reliability was similar among these three CNTs and below optimal standards for clinical use on many subtests. Analyses of group effect sizes, discrimination, and sensitivity and specificity suggested that the CNTs may add incrementally (beyond symptom scores) to the identification of clinical impairment within 24 hr of injury or within a short time period after symptom resolution but do not add significant value over symptom assessment later. The rapid clinical recovery course from concussion and modest stability probably jointly contribute to limited signal detection capabilities of neurocognitive tests outside a brief post-injury window. PMID:26714883

Meniscal material properties are minimally affected by matrix stabilization using glutaraldehyde and glycation with ribose.

PubMed

Hunter, Shawn A; Noyes, Frank R; Haridas, Balakrishna; Levy, Martin S; Butler, David L

2005-05-01

Knee meniscus replacement holds promise, but current allografts are susceptible to biodegradation. Matrix stabilization with glutaraldehyde, a crosslinking agent used clinically to fabricate cardiovascular bioprostheses, or with glycation, a process of crosslinking collagen with sugars such as ribose, is a potential means of rendering tissue resistant to such degradation. However, stabilization should not significantly alter meniscal material properties, which could disturb normal function in the knee. Our objective was to evaluate the effects of glutaraldehyde- and glycation-induced matrix stabilization on the material properties of porcine meniscus. Normal untreated meniscus specimens were tested in confined compression at one of three applied stresses (0.069, 0.208, 0.347 MPa), subjected to either a glutaraldehyde or glycation stabilization treatment, and then re-tested to measure changes in tissue aggregate modulus, permeability, and compressive strain at equilibrium. Changes in these properties significantly increased with glutaraldehyde concentration and exposure time to ribose. One glutaraldehyde and three glycation treatments did not alter aggregate modulus or compressive strain at equilibrium compared to controls (p > 0.10). However, all treatments increased permeability by at least 108% compared to controls (p < 0.001). This study reveals a dose-dependent relationship between meniscal material properties and certain stabilization conditions and identifies treatments that minimally affect these properties. Further research is necessary to determine whether these treatments prevent enzymatic degradation before and after surgical implantation in the knee.

Recommendations for clinical biomarker specimen preservation and stability assessments.

PubMed

Dakappagari, Naveen; Zhang, Hui; Stephen, Laurie; Amaravadi, Lakshmi; Khan, Masood U

2017-04-01

With the wide use of biomarkers to enable critical drug-development decisions, there is a growing concern from scientific community on the need for a 'standardized process' for ensuring biomarker specimen stability and hence, a strong desire to share best practices on preserving the integrity of biomarker specimens in clinical trials and the design of studies to evaluate analyte stability. By leveraging representative industry experience, we have attempted to provide an overview of critical aspects of biomarker specimen stability commonly encountered during clinical development, including: planning of clinical sample collection procedures, clinical site training, selection of sample preservation buffers, shipping logistics, fit-for-purpose stability assessments in the analytical laboratory and presentation of case studies covering widely utilized biomarker specimen types.

Biomechanical comparison of anterior cervical plating and combined anterior/lateral mass plating.

PubMed

Adams, M S; Crawford, N R; Chamberlain, R H; Bse; Sonntag, V K; Dickman, C A

2001-01-01

Previous studies showed anterior plates of older design to be inadequate for stabilizing the cervical spine in all loading directions. No studies have investigated enhancement in stability obtained by combining anterior and posterior plates. To determine which modes of loading are stabilized by anterior plating after a cervical burst fracture and to determine whether adding posterior plating further significantly stabilizes the construct. A repeated-measures in vitro biomechanical flexibility experiment was performed to investigate how surgical destabilization and subsequent addition of hardware components alter spinal stability. Six human cadaveric specimens were studied. Angular range of motion (ROM) and neutral zone (NZ) were quantified during flexion, extension, lateral bending, and axial rotation. Nonconstraining, nondestructive torques were applied while recording three-dimensional motion optoelectronically. Specimens were tested intact, destabilized by simulated burst fracture with posterior distraction, plated anteriorly with a unicortical locking system, and plated with a combined anterior/posterior construct. The anterior plate significantly (p<.05) reduced the ROM relative to normal in all modes of loading and significantly reduced the NZ in flexion and extension. Addition of the posterior plates further significantly reduced the ROM in all modes of loading and reduced the NZ in lateral bending. Anterior plating systems are capable of substantially stabilizing the cervical spine in all modes of loading after a burst fracture. The combined approach adds significant stability over anterior plating alone in treating this injury but may be unnecessary clinically. Further study is needed to assess the added clinical benefits of the combined approach and associated risks.

Dropout revisited: patient- and therapist-initiated discontinuation of psychotherapy as a function of organizational instability.

PubMed

Werbart, Andrzej; Andersson, Håkan; Sandell, Rolf

2014-01-01

To explore the association between the stability or instability of services' organizational structure and patient- and therapist-initiated discontinuation of therapy in routine mental health. Three groups, comprising altogether 750 cases in routine mental health care in eight different clinics, were included: cases with patient-initiated discontinuation, therapist-initiated discontinuation, and patients remaining in treatment. Multilevel multinomial regression was used to estimate three models: An initial, unconditional intercept-only model, another one including patient variables, and a final model with significant patient and therapist variables including the organizational stability of the therapists' clinic. High between-therapist variability was noted. Odds ratios and significance tests indicated a strong association of organizational instability with patient-initiated premature termination in particular. The question of how organizational factors influence the treatment results needs further research. Future studies have to be designed in ways that permit clinically meaningful subdivision of the patients' and the therapists' decisions for premature termination.

Color stability of esthetic restorative materials: a spectrophotometric analysis.

PubMed

Poggio, Claudio; Ceci, Matteo; Beltrami, Riccardo; Mirando, Maria; Wassim, Jaffal; Colombo, Marco

2016-12-01

Objective: The aim of this in vitro study was to evaluate the color stability of different restorative materials (one microfilled composite, one nanofilled composite, one nanohybrid composite and one Ormocer-based composite) after exposure to different staining solutions (coffee, coca-cola and red wine). Material and methods: All materials were polymerized into silicon rings (2 mm ×6 mm ×8 mm) to obtain specimens identical in size. Thirty cylindrical specimens of each material were prepared. They were immersed in staining solutions over a 28-day test period. A colorimetric evaluation according to the CIE L*a*b* system was performed by a blind trained operator at 7, 14, 21, 28 days of the staining process. The Shapiro-Wilk test and Kruskal-Wallis ANOVA were applied to assess significant differences among restorative materials. The paired t -test was applied to test which CIE L*a*b* parameters significantly changed after immersion in staining solutions. Results: All restorative materials showed clinically perceptible color differences after immersion in coffee. L* and b* values showed the highest variability. Coca cola and red wine did not influence the color stability for all restorative materials except for Filtek Supreme XTE. Conclusions: Coffee caused a significant color change in all types of tested composite resins. Filtek Supreme XTE demonstrated alone a staining susceptibility to red wine; no other significant differences among the materials were demonstrated. Long-term exposure to some food dyes (coffee in particular) can significantly affect the color stability of modern esthetic restorative materials regardless of materials' different composition.

EDTA improves stability of whole blood C-peptide and insulin to over 24 hours at room temperature.

PubMed

McDonald, Timothy J; Perry, Mandy H; Peake, Roy W A; Pullan, Nicola J; O'Connor, John; Shields, Beverley M; Knight, Beatrice A; Hattersley, Andrew T

2012-01-01

C-peptide and insulin measurements in blood provide useful information regarding endogenous insulin secretion. Conflicting evidence on sample stability and handling procedures continue to limit the widespread clinical use of these tests. We assessed the factors that altered the stability of insulin and C-peptide in blood. We investigated the impact of preservative type, time to centrifugation, storage conditions and duration of storage on the stability of C-peptide and insulin on three different analytical platforms. C-peptide was stable for at least 24 hours at room temperature in both centrifuged and whole blood collected in K(+)-EDTA and serum gel tubes, with the exception of whole blood serum gel, which decreased to 78% of baseline at 24 hours, (p = 0.008). Insulin was stable at room temperature for 24 hours in both centrifuged and whole blood collected in K(+)-EDTA tubes. In contrast insulin levels decreased in serum gel tubes both centrifuged and whole blood (66% of baseline, p = 0.01 and 76% of baseline p = 0.01, by 24 hours respectively). C-peptide and insulin remained stable after 6 freeze-thaw cycles. The stability of C-peptide and insulin in whole blood K(+)-EDTA tubes negates the need to conform to strict sample handling procedures for these assays, greatly increasing their clinical utility.

In Vitro and In Vivo Evaluations of the Anticalculus Effect of a Novel Stabilized Stannous Fluoride Dentifrice.

PubMed

He, Tao; Anastasia, Mary Kay; Zsiska, Marianne; Farmer, Teresa; Schneiderman, Eva; Milleman, Jeffery L

2017-12-01

To evaluate the effect of a novel stannous fluoride dentifrice with zinc citrate on calculus inhibition using both in vitro and clinical models. Each investigation tested a novel stabilized 0.454% stannous fluoride dentifrice with zinc citrate as an anticalculus agent (Crest® Pro-Health™ smooth formula) compared to a negative control fluoride dentifrice. The in vitro study used the modified Plaque Growth and Mineralization Model (mPGM). Plaque biofilms were prepared and mineralized by alternate immersion of glass rods in human saliva and artificial mineralization solution. Treatments of 25% w/w dentifrice/water slurries were carried out for 60 seconds daily for 6 days, between saliva and mineralization solution immersions. Plaque calcium levels were determined by digestion and inductively coupled plasma optical emission spectroscopy. Student's t-test (p < 0.05) was used for statistical analysis. The clinical study was a parallel group, double-blind, randomized, and controlled trial. Following a dental prophylaxis, subjects entered a two-month run-in phase. At the end, they received a Volpe-Manhold Index (V-MI) calculus examination. Eighty (80) qualified subjects who had formed at least 9 mm of calculus on the linguals of the mandibular anterior teeth were re-prophied and randomly assigned to either the stannous fluoride dentifrice or the negative control. Subjects brushed twice daily, unsupervised, during the three-month test period, returning at Weeks 6 and 12 for safety and V-MI examinations. Statistical analyses were via ANCOVA. In vitro mPGM: The stabilized stannous fluoride dentifrice showed 20% less in vitro tartar formation, measured as calcium accumulation normalized by biofilm mass, versus the negative control (106.95 versus 133.04 µg Ca/mg biofilm, respectively, p < 0.05). Clinical Trial: Seventy-eight (78) subjects completed with fully evaluable data. The stannous fluoride dentifrice group had 15.1% less adjusted mean calculus at Week 6 compared to the negative control group (p = 0.05) and 21.7% less calculus at Week 12 (p < 0.01). Both dentifrices were well-tolerated. The stannous fluoride dentifrice produced significant anticalculus benefits in vitro and in a clinical trial compared to a negative control.

46 CFR 170.085 - Information required before a stability test.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 46 Shipping 7 2012-10-01 2012-10-01 false Information required before a stability test. 170.085... STABILITY STABILITY REQUIREMENTS FOR ALL INSPECTED VESSELS Plan Approval § 170.085 Information required before a stability test. If a stability test is to be performed, a stability test procedure that contains...

46 CFR 170.085 - Information required before a stability test.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 7 2014-10-01 2014-10-01 false Information required before a stability test. 170.085... STABILITY STABILITY REQUIREMENTS FOR ALL INSPECTED VESSELS Plan Approval § 170.085 Information required before a stability test. If a stability test is to be performed, a stability test procedure that contains...

46 CFR 170.085 - Information required before a stability test.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 7 2011-10-01 2011-10-01 false Information required before a stability test. 170.085... STABILITY STABILITY REQUIREMENTS FOR ALL INSPECTED VESSELS Plan Approval § 170.085 Information required before a stability test. If a stability test is to be performed, a stability test procedure that contains...

Development of Stabilimax NZ From Biomechanical Principles.

PubMed

Panjabi, Manohar M; Timm, Jens Peter

2007-01-01

Traditionally, spinal degeneration and injury have been associated with abnormal intervertebral motion; thus, treatment for lowback pain has centered on prevention of motion through spinal fusion. Although the rate of successful spinal fusions is improving, complications such as adjacent-level syndrome emphasize the need to develop alternatives for treating spinal degeneration. In an effort to improve the clinical outcomes associated with such treatment, we hypothesized that spinal stabilization and a consequent reduction in symptoms is achievable without the harsh restrictions to spinal motion imposed by fusion. This idea was based on the principle of the neutral zone and the neutral zone hypothesis of back pain. Performance requirements for a novel device were determined through a series of biomechanical experiments. From these data, the Stabilimax NZ was developed to provide stabilization to a degenerated or surgically destabilized spine while maintaining the maximum possible total range of motion. Applied Spine Technologies Inc has tested 70 bilateral assemblies of the final design of the Stabilimax NZ, and all exceeded the biomechanical, static, fatigue, wear, and histological requirements necessary to initiate clinical investigation. The Stabilimax NZ device has been systematically designed and tested under protocols developed by Applied Spine Technologies in conjunction with Panjabi, Patwardhan, and Goel. The device decreased the neutral zone in destabilized spines while maintaining substantial range of motion. Development testing has been submitted to the US Food and Drug Administration and permission obtained to initiate an investigational device exemption trial to clinically investigate the efficacy of the Stabilimax NZ device.

Factorial structure of the German version of the dimensional assessment of personality pathology-basic questionnaire in clinical and nonclinical samples.

PubMed

Pukrop, R; Gentil, I; Steinbring, I; Steinmeyer, E

2001-10-01

The Dimensional Assessment of Personality Pathology-Basic Questionnaire (DAPP-BQ) assesses 18 traits to provide a systematic representation of the overall domain of personality disorders. We tested the cross-cultural stability of the prediction that four higher-order factors (Emotional Dysregulation, Dissocial Behavior, Inhibitedness, and Compulsivity) underlie the 18 basic traits. A total of 81 patients who were primarily treated for an Axis II personality disorder and N = 166 healthy control patients completed the German version of the DAPP-BQ. Results clearly confirmed cross-cultural stability of the postulated four-factor structure in both samples, accounting for 74.7% (clinical sample), and 65.7% (nonclinical sample) of the total variance. All four higher-order factors showed specific correlational relationships with dimensional assessments of DSM-IV personality disorders.

Initial stability of cementless acetabular cups: press-fit and screw fixation interaction--an in vitro biomechanical study.

PubMed

Tabata, Tomonori; Kaku, Nobuhiro; Hara, Katsutoshi; Tsumura, Hiroshi

2015-04-01

Press-fit and screw fixation are important technical factors to achieve initial stability of a cementless acetabular cup for good clinical results of total hip arthroplasty. However, how these factors affect one another in initial cup fixation remains unclear. Therefore, this study aimed to evaluate the mutual influence between press-fit and screw fixation on initial cup stability. Foam bone was subjected to exact hemispherical-shape machining to diameters of 48, 48.5 and 49 mm. A compressive force was applied to ensure seating of a 48-mm-diameter acetabular cup in the foam bone prior to testing. Screws were inserted in six different conditions and tightened in a radial direction at the same torque strength. Then, the socket was rotated with a twist-testing machine, and the torque value at the start of axial rotation between the socket and the foam bone was measured under each screw condition. The torque values for the 48-mm-diameter reaming were >20 N m higher than those for the 48.5- and 49-mm-diameter reaming in each screw condition, indicating that press-fit fixation is stronger than screw fixation. Meanwhile, torque values for the 48.5- and 49-mm-diameter reaming tended to increase with increasing the number of screws. According to our experiment, press-fit fixation of a cementless acetabular cup achieved rigid stability. Although the supplemental screws increased stability of the implant under good press-fit conditions, they showed little impact on whole-cup stability. In the case of insufficient press-fit fixation, cup stability depends on screw stability and increasing the number of additional screws increases cup stability.

The efficacy of short (6 mm) dental implants with a novel thread design.

PubMed

Bechara, Soheil; Nimčenko, Tatjana; Kubilius, Ričardas

2017-01-01

To assess efficacy of short (6 mm) implants with a novel macrostructure and thread design placed in a compromised bone situations of edentulous posterior regions of maxilla (3-4 mm of bone height under sinus floor) as compared to results of clinical situations treated with simultaneous maxillary sinus grafting and placement of long (≥10 mm) implants of the same company. Clinical cases of conducted clinical study. Patients with compromised bone height in edentulous posterior regions of maxilla were randomly divided into two groups. Short (6mm length) implant treatment conducted in the test group and simultaneous sinus lift with standard length implant placement treatment in the control group. In general implant stability quotient (ISQ) and marginal bone level (MBL) changes values in both groups were comparable. However, significant negative correlation was found between implant's diameter and MBL changes. Implant's length has little if none impact on initial implant anchorage, especially in greatly compromised residual bone situations. Results have confirmed that implant initial stability mainly depends on implant's macro-design and further its development on implant's micro-design: namely, implant diameter rather than length, tapered shape and improved thread design determines primarily acquired mechanical anchorage, while bioactive surface treatment ensures development of biological stability.

Machine Learning methods for Quantitative Radiomic Biomarkers.

PubMed

Parmar, Chintan; Grossmann, Patrick; Bussink, Johan; Lambin, Philippe; Aerts, Hugo J W L

2015-08-17

Radiomics extracts and mines large number of medical imaging features quantifying tumor phenotypic characteristics. Highly accurate and reliable machine-learning approaches can drive the success of radiomic applications in clinical care. In this radiomic study, fourteen feature selection methods and twelve classification methods were examined in terms of their performance and stability for predicting overall survival. A total of 440 radiomic features were extracted from pre-treatment computed tomography (CT) images of 464 lung cancer patients. To ensure the unbiased evaluation of different machine-learning methods, publicly available implementations along with reported parameter configurations were used. Furthermore, we used two independent radiomic cohorts for training (n = 310 patients) and validation (n = 154 patients). We identified that Wilcoxon test based feature selection method WLCX (stability = 0.84 ± 0.05, AUC = 0.65 ± 0.02) and a classification method random forest RF (RSD = 3.52%, AUC = 0.66 ± 0.03) had highest prognostic performance with high stability against data perturbation. Our variability analysis indicated that the choice of classification method is the most dominant source of performance variation (34.21% of total variance). Identification of optimal machine-learning methods for radiomic applications is a crucial step towards stable and clinically relevant radiomic biomarkers, providing a non-invasive way of quantifying and monitoring tumor-phenotypic characteristics in clinical practice.

Trunk muscle exercises as a means of improving postural stability in people with Parkinson's disease: a protocol for a randomised controlled trial.

PubMed

Hubble, Ryan P; Naughton, Geraldine A; Silburn, Peter A; Cole, Michael H

2014-12-31

Exercise has been shown to improve clinical measures of strength, balance and mobility, and in some cases, has improved symptoms of tremor and rigidity in people with Parkinson's disease (PD). However, to date, no research has examined whether improvements in trunk control can remedy deficits in dynamic postural stability in this population. The proposed randomised controlled trial aims to establish whether a 12-week exercise programme aimed at improving dynamic postural stability in people with PD; (1) is more effective than education; (2) is more effective when training frequency is increased; and (3) provides greater long-term benefits than education. Forty-five community-dwelling individuals diagnosed with idiopathic PD with a falls history will be recruited. Participants will complete baseline assessments including tests of cognition, vision, disease severity, fear of falling, mobility and quality of life. Additionally, participants will complete a series of standing balance tasks to evaluate static postural stability, while dynamic postural control will be measured during walking using head and trunk-mounted three-dimensional accelerometers. Following baseline testing, participants will be randomly-assigned to one of three intervention groups, who will receive either exercise once per week, exercise 3 days/week, or education. Participants will repeat the same battery of tests conducted at baseline after the 12-week intervention and again following a further 12-week sustainability period. This study has the potential to show that low-intensity and progressive trunk exercises can provide a non-invasive and effective means for maintaining or improving postural stability for people with PD. Importantly, if the programme is noted to be effective, it could be easily performed by patients within their home environment or under the guidance of available allied health professionals. The protocol for this study is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12613001175763). Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Neuroleptics as therapeutic compounds stabilizing neuromuscular transmission in amyotrophic lateral sclerosis

PubMed Central

Patten, Shunmoogum A.; Aggad, Dina; Martinez, Jose; Tremblay, Elsa; Petrillo, Janet; Armstrong, Gary A.B.; Maios, Claudia; Liao, Meijiang; Ciura, Sorana; Wen, Xiao-Yan; Rafuse, Victor; Ichida, Justin; Zinman, Lorne; Julien, Jean-Pierre; Kabashi, Edor; Robitaille, Richard; Korngut, Lawrence; Parker, J. Alexander

2017-01-01

Amyotrophic lateral sclerosis (ALS) is a rapidly progressing, fatal disorder with no effective treatment. We used simple genetic models of ALS to screen phenotypically for potential therapeutic compounds. We screened libraries of compounds in C. elegans, validated hits in zebrafish, and tested the most potent molecule in mice and in a small clinical trial. We identified a class of neuroleptics that restored motility in C. elegans and in zebrafish, and the most potent was pimozide, which blocked T-type Ca2+ channels in these simple models and stabilized neuromuscular transmission in zebrafish and enhanced it in mice. Finally, a short randomized controlled trial of sporadic ALS subjects demonstrated stabilization of motility and evidence of target engagement at the neuromuscular junction. Simple genetic models are, thus, useful in identifying promising compounds for the treatment of ALS, such as neuroleptics, which may stabilize neuromuscular transmission and prolong survival in this disease. PMID:29202456

Neuroleptics as therapeutic compounds stabilizing neuromuscular transmission in amyotrophic lateral sclerosis.

PubMed

Patten, Shunmoogum A; Aggad, Dina; Martinez, Jose; Tremblay, Elsa; Petrillo, Janet; Armstrong, Gary Ab; La Fontaine, Alexandre; Maios, Claudia; Liao, Meijiang; Ciura, Sorana; Wen, Xiao-Yan; Rafuse, Victor; Ichida, Justin; Zinman, Lorne; Julien, Jean-Pierre; Kabashi, Edor; Robitaille, Richard; Korngut, Lawrence; Parker, J Alexander; Drapeau, Pierre

2017-11-16

Amyotrophic lateral sclerosis (ALS) is a rapidly progressing, fatal disorder with no effective treatment. We used simple genetic models of ALS to screen phenotypically for potential therapeutic compounds. We screened libraries of compounds in C. elegans, validated hits in zebrafish, and tested the most potent molecule in mice and in a small clinical trial. We identified a class of neuroleptics that restored motility in C. elegans and in zebrafish, and the most potent was pimozide, which blocked T-type Ca2+ channels in these simple models and stabilized neuromuscular transmission in zebrafish and enhanced it in mice. Finally, a short randomized controlled trial of sporadic ALS subjects demonstrated stabilization of motility and evidence of target engagement at the neuromuscular junction. Simple genetic models are, thus, useful in identifying promising compounds for the treatment of ALS, such as neuroleptics, which may stabilize neuromuscular transmission and prolong survival in this disease.

Postural Stability of Special Warfare Combatant-Craft Crewmen With Tactical Gear.

PubMed

Morgan, Paul M; Williams, Valerie J; Sell, Timothy C

The US Naval Special Warfare's Special Warfare Combatant-Craft Crewmen (SWCC) operate on small, high-speed boats while wearing tactical gear (TG). The TG increases mission safety and success but may affect postural stability, potentially increasing risk for musculoskeletal injury. Therefore, the purpose of this study was to examine the effects of TG on postural stability during the Sensory Organization Test (SOT). Eight SWCC performed the SOT on NeuroCom's Balance Manager with TG and with no tactical gear (NTG). The status of gear was performed in randomized order. The SOT consisted of six different conditions that challenge sensory systems responsible for postural stability. Each condition was performed for three trials, resulting in a total of 18 trials. Overall performance, each individual condition, and sensory system analysis (somatosensory, visual, vestibular, preference) were scored. Data were not normally distributed therefore Wilcoxon signed-rank tests were used to compare each variable (ρ = .05). No significant differences were found between NTG and TG tests. No statistically significant differences were detected under the two TG conditions. This may be due to low statistical power, or potentially insensitivity of the assessment. Also, the amount and distribution of weight worn during the TG conditions, and the SWCC's unstable occupational platform, may have contributed to the findings. The data from this sample will be used in future research to better understand how TG affects SWCC. The data show that the addition of TG used in our study did not affect postural stability of SWCC during the SOT. Although no statistically significant differences were observed, there are clinical reasons for continued study of the effect of increased load on postural stability, using more challenging conditions, greater surface perturbations, dynamic tasks, and heavier loads. 2016.

Vitamin D and parathyroid hormone are associated with gait instability and poor balance performance in mid-age to older aged women.

PubMed

Bird, Marie-Louise; El Haber, Natalie; Batchelor, Frances; Hill, Keith; Wark, John D

2018-01-01

Vitamin D status and parathyroid hormone (PTH) levels influence the risk of accidental falls in older people, but the mechanisms underlying this effect remain unclear. Investigate the relationship between circulating PTH and 25 hydroxyvitamin D (25-OHD) levels and clinical tests of gait stability and balance as physical fall risk factors. We hypothesized that high levels of PTH and low 25-OHD levels would be significantly associated with gait stability and decreased balance performance. Observational cohort study. Australian community. 119 healthy, ambulatory female twin adults aged 47-80 years residing in Victoria, Australia. Serum PTH and 25-OHD levels with clinical tests of gait stability [double support duration (DSD)] and dynamic balance (Step Test). Associations were investigated by regression analysis and by comparing groups divided by tertiles of PTH (<3.5, 3.5-4.9, >4.9pmol/L) and 25-OHD (<53, 53-75, >75 nmol/L) using analysis of variance. Serum PTH was associated positively with DSD, with an increase of 10.6-15.7% when the mid and highest PTH tertiles were compared to the lowest tertile (p <0.025) when 25-OHD was included in the regression analysis. 25-OHD was significantly associated with DSD (greater by 10.6-11.1% when lowest and mid-tertiles compared with the highest 25-OHD tertile) (p <0.025) and dynamic balance (better performance by 12.6% in the highest compared with the lowest 25OHD tertile) (p <0.025). These findings reveal an important new relationship between parathyroid hormone and gait stability parameters and add to understanding of the role of 25-OHD in motor control of gait and dynamic balance in community-dwelling women across a wide age span. Copyright © 2017 Elsevier B.V. All rights reserved.

Effect of footwear on standing balance in healthy young adult males.

PubMed

Alghadir, Ahmad H; Zafar, Hamayun; Anwer, Shahnawaz

2018-03-01

The present study aimed to evaluate the effect of footwear on standing balance in healthy young adult males. Thirty healthy male participants aged 20-30 years were tested for standing balance on the Balance Master on three occasions, including wearing a sandal, standard shoe, or no footwear (barefoot). The tests of postural stability include; "Modified Clinical Test of Sensory Interaction on Balance" (mCTSIB), "Unilateral Stance" (US), and the "Limits of Stability" (LOS). The balance scores (mCTSIB, US, and LOS) was analyzed. There was a significant effect between footwear conditions for mCTIB with eye closed on a firm surface (p=0.002). There was a significant effect between footwear conditions for the US with eye open and closed (p⟨0.05). There was a significant effect between footwear conditions for LOS reaction time during forward movement (p=0.02). Similarly, there was a significant effect between footwear conditions for LOS reaction time during left side movement (p=0.01). Wearing sandals compared to bare feet significantly increased postural sway and reduced stability in healthy young adult males. However, wearing a standard shoe compared to bare feet did not significantly affect balance scores in standing.

Effects of scapulohumeral rehabilitation protocol on trunk control recovery in patients with subacute stroke: A pilot randomized controlled trial.

PubMed

Dell'Uomo, Daniela; Morone, Giovanni; Centrella, Antonio; Paolucci, Stefano; Caltagirone, Carlo; Grasso, Maria Grazia; Traballesi, Marco; Iosa, Marco

2017-01-01

Despite upper limb rehabilitation is widely investigated in patients with stroke, the effects of scapulohumeral rehabilitation on trunk stabillization are mainly unknown. To test the effects of scapulohumeral rehabilitation protocol on trunk control recovery in patients with subacute stroke. A pilot randomized controlled trial with two groups of 14 patients each one performing 20 minutes per day, 5 days a week, for 6 weeks in add on to standard therapy. Experimental group performed a specific scapulohumeral rehabilitation protocol aiming to improve trunk competencies whereas control group performed conventional arm rehabilitation. Clinical scale tests and accelerometric evaluations were performed pre- and post-treatment. Experimental groups showed better scores at discharge at Trunk impairment Scale (p < 0.001), Barthel Index (p = 0.024), Trunk Control Test (p = 0.002), Sitting Balance Scale (p = 0.002), but neither at Fugl-Meyer Scale (p = 0.194) nor Modified Ashworth Scale (p = 0.114). Accelerometric analysis showed higher stability of trunk for experimental group especially during static and dynamic items. The recovery of scapulohumeral functions also acts on trunk stabilization post-stroke.

Effect of chronic kidney disease on warfarin management in a pharmacist-managed anticoagulation clinic.

PubMed

Kleinow, Megan E; Garwood, Candice L; Clemente, Jennifer L; Whittaker, Peter

2011-09-01

There is growing evidence that kidney disease affects hepatically cleared drugs. Accordingly, we hypothesized that chronic kidney disease (CKD) would disrupt anticoagulation of warfarin-treated patients and thereby increase the amount of management required to maintain appropriate anticoagulation. Specifically, we anticipated that more dose manipulations (both dose changes and transient dose adjustments) and shorter times between scheduled clinic visits would be required for anticoagulation patients with CKD. To determine how CKD affected warfarin maintenance dose, anticoagulation stability, the proportion of clinic visits that necessitated a dose manipulation (either a change in the prescribed weekly dose or a transient dose adjustment), and the length of time between scheduled visits in 2 pharmacist-managed anticoagulation clinics. Our retrospective, cohort chart review investigated warfarin response in anticoagulation clinic patients. From the clinic database of patients with an international normalized ratio (INR) target range of 2.0-3.0, we matched 20 of 24 patients with CKD (estimated creatinine clearance less than 60 mL per minute) to 20 comparison group patients (estimated creatinine clearance greater than 60 mL per minute) based on parameters demonstrated to affect warfarin dose: ethnicity, gender, age, body surface area, and simvastatin use. We calculated the average weekly dose used to maintain target INR (assessment period range=116-1,408 days). To evaluate anticoagulation stability and patient management, we quantified several parameters, including the percentage of total time in therapeutic range, the proportion of clinic visits that required a dose change, and the time between scheduled visits. We compared group means using t-tests, and categorical data were compared using Fisher's exact test. Our population was predominantly female (75%) and of African ancestry (95%); average age 60 years. Patients with CKD required a 24% lower dose than the comparison group (mean [SD]=35.9 [10.7] vs. 47.0 [11.2] mg per week, P=0.003) and spent less time in therapeutic range required increased clinic management versus the comparison group, as indicated by a significantly higher proportion of clinic visits at which dose changes occurred (22% vs. 12%, P<0.001) and a decreased time between scheduled visits (mean [SD] of 16.0 [3.2] days vs. 19.7 [3.4] days, respectively, P=0.001). CKD was associated with both decreased warfarin maintenance dose and decreased anticoagulation stability which, in turn, required more frequent and intensive anticoagulation clinic management.

Stability and alignment do not improve by using patient-specific instrumentation in total knee arthroplasty: a randomized controlled trial.

PubMed

Kosse, Nienke M; Heesterbeek, Petra J C; Schimmel, Janneke J P; van Hellemondt, Gijs G; Wymenga, Ate B; Defoort, Koen C

2018-06-01

The primary aim of the study was to examine stability and alignment after total knee arthroplasty (TKA) using patient-specific instrumentation (PSI) and conventional instrumentation (CI). The hypothesis was that stability and alignment would be better using PSI than CI, 12 months postoperatively. The secondary aim included the evaluation of clinical outcomes after TKA. In this prospective randomized controlled trial, 42 patients with knee osteoarthritis received a Genesis II PS prosthesis with either PSI or CI. Patients visited the hospital preoperatively and postoperatively after 6 weeks and 3 and 12 months. To evaluate stability, varus-valgus laxity was determined in extension and flexion using stress radiographs 12 months postoperatively. Three months postoperatively, a long-leg radiograph and CT scan were obtained to measure hip-knee-ankle (HKA) alignment and component rotation. Furthermore, frontal and sagittal alignment of the components, the Knee Society Score, VAS Pain, VAS Satisfaction, Knee injury and Osteoarthritis Outcome score, Patella score (Kujala), University of California Los Angeles activity score, anterior-posterior laxity, (serious) adverse device-related events, and intraoperative complications were reported. The clinical outcomes were compared using independent t tests or non-parametric alternatives, and repeated measurements ANOVA with a significance level of p < 0.05. No significant differences were found between the two groups regarding stability, HKA angle, and rotational alignment. In four patients, the PSI did not fit correctly on the tibia and/or femur requiring intraoperative modifications. Both groups improved significantly over time on all clinical outcomes, with no significant differences between the groups 12 months postoperatively. The PSI group showed less tibial slope than the patients in the CI group [PSI 2.6° versus CI 4.8° (p = 0.02)]. Finally, the PSI group more frequently received a thinner insert size than the CI group (p = 0.03). Patients operated with PSI did not differ from CI in terms of stability and alignment. However, in the PSI group ligament releases were more often required intraoperatively. Furthermore, the two methods did not show different clinical results. It seems that the preoperative planning for the PSI facilitates more conservative bone cuts than CI, but whether this is clinically relevant should be investigated. Since PSI is more expensive and time consuming than CI, and does not outperform CI with regard to clinical results, we recommend to use CI. I.

[Feasibility Study on Digital Signal Processor and Gear Pump of Uroflowmeter Calibration Device].

PubMed

Yuan, Qing; Ji, Jun; Gao, Jiashuo; Wang, Lixin; Xiao, Hong

2016-08-01

It will cause hidden trouble on clinical application if the uroflowmeter is out of control.This paper introduces a scheme of uroflowmeter calibration device based on digital signal processor(DSP)and gear pump and shows studies of its feasibility.According to the research plan,we analyzed its stability,repeatability and linearity by building a testing system and carried out experiments on it.The flow test system is composed of DSP,gear pump and other components.The test results showed that the system could produce a stable water flow with high precision of repeated measurement and different flow rate.The test system can calibrate the urine flow rate well within the range of 9~50mL/s which has clinical significance,and the flow error is less than 1%,which meets the technical requirements of the calibration apparatus.The research scheme of uroflowmeter calibration device on DSP and gear pump is feasible.

THE DYNAMIC LEAP AND BALANCE TEST (DLBT): A TEST-RETEST RELIABILITY STUDY

PubMed Central

Newman, Thomas M.; Smith, Brent I.; John Miller, Sayers

2017-01-01

Background There is a need for new clinical assessment tools to test dynamic balance during typical functional movements. Common methods for assessing dynamic balance, such as the Star Excursion Balance Test, which requires controlled movement of body segments over an unchanged base of support, may not be an adequate measure for testing typical functional movements that involve controlled movement of body segments along with a change in base of support. Purpose/hypothesis The purpose of this study was to determine the reliability of the Dynamic Leap and Balance Test (DLBT) by assessing its test-retest reliability. It was hypothesized that there would be no statistically significant differences between testing days in time taken to complete the test. Study Design Reliability study Methods Thirty healthy college aged individuals participated in this study. Participants performed a series of leaps in a prescribed sequence, unique to the DLBT test. Time required by the participants to complete the 20-leap task was the dependent variable. Subjects leaped back and forth from peripheral to central targets alternating weight bearing from one leg to the other. Participants landed on the central target with the tested limb and were required to stabilize for two seconds before leaping to the next target. Stability was based upon qualitative measures similar to Balance Error Scoring System. Each assessment was comprised of three trials and performed on two days with a separation of at least six days. Results Two-way mixed ANOVA was used to analyze the differences in time to complete the sequence between the three trial averages of the two testing sessions. Intraclass Correlation Coefficient (ICC3,1) was used to establish between session test-retest reliability of the test trial averages. Significance was set a priori at p ≤ 0.05. No significant differences (p > 0.05) were detected between the two testing sessions. The ICC was 0.93 with a 95% confidence interval from 0.84 to 0.96. Conclusion This test is a cost-effective, easy to administer and clinically relevant novel measure for assessing dynamic balance that has excellent test-retest reliability. Clinical relevance As a new measure of dynamic balance, the DLBT has the potential to be a cost-effective, challenging and functional tool for clinicians. Level of Evidence 2b PMID:28900556

Advances in simultaneous DSC-FTIR microspectroscopy for rapid solid-state chemical stability studies: some dipeptide drugs as examples.

PubMed

Lin, Shan-Yang; Wang, Shun-Li

2012-04-01

The solid-state chemistry of drugs has seen growing importance in the pharmaceutical industry for the development of useful API (active pharmaceutical ingredients) of drugs and stable dosage forms. The stability of drugs in various solid dosage forms is an important issue because solid dosage forms are the most common pharmaceutical formulation in clinical use. In solid-state stability studies of drugs, an ideal accelerated method must not only be selected by different complicated methods, but must also detect the formation of degraded product. In this review article, an analytical technique combining differential scanning calorimetry and Fourier-transform infrared (DSC-FTIR) microspectroscopy simulates the accelerated stability test, and simultaneously detects the decomposed products in real time. The pharmaceutical dipeptides aspartame hemihydrate, lisinopril dihydrate, and enalapril maleate either with or without Eudragit E were used as testing examples. This one-step simultaneous DSC-FTIR technique for real-time detection of diketopiperazine (DKP) directly evidenced the dehydration process and DKP formation as an impurity common in pharmaceutical dipeptides. DKP formation in various dipeptides determined by different analytical methods had been collected and compiled. Although many analytical methods have been applied, the combined DSC-FTIR technique is an easy and fast analytical method which not only can simulate the accelerated drug stability testing but also at the same time enable to explore phase transformation as well as degradation due to thermal-related reactions. This technique offers quick and proper interpretations. Copyright © 2012 Elsevier B.V. All rights reserved.

Reflex-mediated dynamic neuromuscular stabilization in stroke patients: EMG processing and ultrasound imaging.

PubMed

Yoon, Hyun S; You, Joshua Sung H

2017-07-20

Postural core instability is associated with poor dynamic balance and a high risk of serious falls. Both neurodevelopmental treatment (NDT) and dynamic neuromuscular stabilization (DNS) core stabilization exercises have been used to improve core stability, but the outcomes of these treatments remain unclear. This study was undertaken to examine the therapeutic effects of NDT and DNS core stabilization exercises on muscular activity, core stability, and core muscle thickness. Ten participants (5 healthy adults; 5 hemiparetic stroke patients) were recruited. Surface electromyography (EMG) was used to determine core muscle activity of the transversus abdominis/internal oblique (TrA/IO), external oblique (EO), and rectus abdominis (RA) muscles. Ultrasound imaging was used to measure transversus abdominals/internal oblique (TrA/IO) thickness, and a pressure biofeedback unit (PBU) was used to measure core stability during the DNS and NDT core exercise conditions. Data are reported as median and range and were compared using nonparametric Mann - Whitney U test and Wilcoxon signed rank test at p< 0.05. Both healthy and hemiparetic stroke groups showed greater median EMG amplitude in the TrA/IO muscles, core stability, and muscle thickness values during the DNS exercise condition than during the NDT core exercise condition, respectively (p< 0.05). However, the relative changes in the EMG amplitude, core stability, and muscle thickness values were greater during the DNS exercise condition than during the NDT core exercise condition in the hemiparetic stroke patient group (p< 0.05). Our novel results provide the first clinical evidence that DNS is more effective than NDT in both healthy and hemiparetic stroke subjects to provide superior deep core muscle activation, core stabilization, and muscle thickness. Moreover, such advantageous therapeutic benefits of the DNS core stabilization exercise over the NDT exercise were more apparent in the hemiparetis stroke patients than normal controls.

Minimal important difference for 6-minute walk test distances among patients with chronic heart failure.

PubMed

Täger, Tobias; Hanholz, Wiebke; Cebola, Rita; Fröhlich, Hanna; Franke, Jennifer; Doesch, Andreas; Katus, Hugo A; Wians, Frank H; Frankenstein, Lutz

2014-09-01

The 6-minute walk test (6 WT) is an established tool in the assessment of endurance and prognosis in patients with chronic heart failure (CHF). For these patients there is very limited data on biological variation of 6 WT distances. We determined the minimal important difference (MID) for the 6 WT in patients with stable systolic CHF. Two cohorts of patients with stable systolic CHF were included from the outpatients' clinic of the University of Heidelberg. In these cohorts, two 6 WT measurements were performed - in cohort 1 (n=461) 180 days and in cohort 2 (n=512) 365 days apart. Stability was defined as the absence of clinical events (3 months before the first test, between both tests, and 6 months after the second test) and stability of symptoms (NYHA) between tests. Using a standard error of measurement (SEM)-based approach, we determined the MID for both cohorts. The intraclass correlation coefficient was 0.89 at 180 days and 0.88 at 365 days. The results were consistent for groups stratified for age, gender, etiology of CHF, and individual NYHA class. The MID for the 6 WT in stable CHF patients was 35 m and 37 m between presentation and 180 and 365 days, respectively. Submaximal exercise capacity as represented by the 6 WT varies little in stable CHF patients for up to 1-year intervals. The MID for changes in 6 WT values in patients with stable CHF over a period of 6 to 12 months is ~ 36 m. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Colour stability and opacity of resin cements and flowable composites for ceramic veneer luting after accelerated ageing.

PubMed

Archegas, Lucí Regina Panka; Freire, Andrea; Vieira, Sergio; Caldas, Danilo Biazzetto de Menezes; Souza, Evelise Machado

2011-11-01

Colour changes of the luting material can become clinically visible affecting the aesthetic appearance of thin ceramic laminates. The aim of this in vitro study was to evaluate the colour stability and opacity of light- and dual-cured resin cements and flowable composites after accelerated ageing. The luting agents were bonded (0.2 mm thick) to ceramic disks (0.75 mm thick) built with the pressed-ceramic IPS Aesthetic Empress (n=7). Colour measurements were determined using a FTIR spectrophotometer before and after accelerated ageing in a weathering machine with a total energy of 150 kJ. Changes in colour (ΔE) and opacity (ΔO) were obtained using the CIE L*a*b* system. The results were submitted to one-way ANOVA, Tukey HSD test and Student's t test (α=5%). All the materials showed significant changes in colour and opacity. The ΔE of the materials ranged from 0.41 to 2.40. The highest colour changes were attributed to RelyX ARC and AllCem, whilst lower changes were found in Variolink Veneer, Tetric Flow and Filtek Z350 Flow. The opacity of the materials ranged from -0.01 to 1.16 and its variation was not significant only for Opallis Flow and RelyX ARC. The accelerated ageing led to colour changes in all the evaluated materials, although they were considered clinically acceptable (ΔE<3). Amongst the dual-cured resin cements, Variolink II demonstrated the highest colour stability. All the flowable composites showed proper colour stability for the luting of ceramic veneers. After ageing, an increase in opacity was observed for most of the materials. Copyright © 2011 Elsevier Ltd. All rights reserved.

Exceptionally Stable Fluorous Emulsions for the Intravenous Delivery of Volatile General Anesthetics

PubMed Central

Jee, Jun-Pil; Parlato, Maria C.; Perkins, Mark G.; Mecozzi, Sandro; Pearce, Robert A.

2012-01-01

Background Intravenous delivery of volatile fluorinated anesthetics has a number of potential advantages when compared to the current inhalation method of administration. We reported previously that the IV delivery of sevoflurane can be achieved through an emulsion composed of a linear fluorinated diblock copolymer, a stabilizer, and the anesthetic. However, this original emulsion was subject to particle size growth that would limit its potential clinical utility. We hypothesized that the use of bulkier fluorous groups and smaller poly(ethylene glycol) moieties in the polymer design would result in improved emulsion stability while maintaining anesthetic functionality. Methods The authors prepared emulsions incorporating sevoflurane, perfluorooctyl bromide as a stabilizing agent, and combinations of linear fluorinated diblock copolymer and a novel dibranched fluorinated diblock copolymer. Emulsion stability was assessed using dynamic light scattering. The ability of the emulsions to induce anesthesia was tested in vivo by administering them intravenously to fifteen male Sprague-Dawley rats and measuring loss of the forepaw righting reflex. Results 20% (volume/volume) sevoflurane emulsions incorporating mixtures of dibranched- and linear diblock copolymers had improved stability, with those containing an excess of the dibranched polymers displaying stability of particle size for over one year. The ED50s for loss of forepaw righting reflex were all similar, and ranged between 0.55 and 0.60 ml/kg body weight. Conclusions Hemifluorinated dibranched polymers can be used to generate exceptionally stable sevoflurane nanoemulsions, as required of formulations intended for clinical use. Intravenous delivery of the emulsion in rats resulted in induction of anesthesia with rapid onset and smooth and rapid recovery. PMID:22354241

Stability comparison between commercially available mini-implants and a novel design: part 1.

PubMed

Hong, Christine; Lee, Haofu; Webster, Richard; Kwak, Jinny; Wu, Benjamin M; Moon, Won

2011-07-01

To compare mechanical stability among five mini-implant designs--a newly invented design and four commercially available designs that vary by shape and threading; to calculate external surface area of each design using high-resolution micro-computed tomography; and to evaluate the relationship between surface area and stability results. The four commercially available mini-implants--single-threaded and cylindrical (SC), single-threaded and tapered (ST), double-threaded and cylindrical (DC), double-threaded and tapered (DT)--and a new implant that is designed to engage mostly in cortical bone with shorter and wider dimensions (N1) were inserted in simulated bone with cortical and trabecular bone layers. The mechanical study consisted of torque measurements and lateral displacement tests. External surface area was computed using a 25-µm micro-CT. Maximum insertion torque, maximum removal torque, and force levels for displacements were the highest in N1, followed by DT, ST, DC, and SC (α  =  .05). The surface area was largest in DT, followed by N1, ST, DC, and SC. Surface area engaged in cortical bone, however, was the greatest in N1. The surface area of mini-implants had positive correlation with stability. Among commercial designs, both added tapering and double threading improved stability. N1 was the most stable design within this research design. The new design has the potential to be clinically superior; it has enhanced stability and there is diminished risk of endangering nearby anatomic structures during placement and orthodontic treatment, but the design requires refinements to reduce insertion torque to avoid clinical difficulty and patient discomfort.

21 CFR 211.166 - Stability testing.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Stability testing. 211.166 Section 211.166 Food... Stability testing. (a) There shall be a written testing program designed to assess the stability characteristics of drug products. The results of such stability testing shall be used in determining appropriate...

21 CFR 211.166 - Stability testing.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Stability testing. 211.166 Section 211.166 Food... Stability testing. (a) There shall be a written testing program designed to assess the stability characteristics of drug products. The results of such stability testing shall be used in determining appropriate...

21 CFR 211.166 - Stability testing.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Stability testing. 211.166 Section 211.166 Food... Stability testing. (a) There shall be a written testing program designed to assess the stability characteristics of drug products. The results of such stability testing shall be used in determining appropriate...

21 CFR 211.166 - Stability testing.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Stability testing. 211.166 Section 211.166 Food... Stability testing. (a) There shall be a written testing program designed to assess the stability characteristics of drug products. The results of such stability testing shall be used in determining appropriate...

Application of the Actor-Critic Architecture to Functional Electrical Stimulation Control of a Human Arm

PubMed Central

Thomas, Philip; Branicky, Michael; van den Bogert, Antonie; Jagodnik, Kathleen

2010-01-01

Clinical tests have shown that the dynamics of a human arm, controlled using Functional Electrical Stimulation (FES), can vary significantly between and during trials. In this paper, we study the application of the actor-critic architecture, with neural networks for the both the actor and the critic, as a controller that can adapt to these changing dynamics of a human arm. Development and tests were done in simulation using a planar arm model and Hill-based muscle dynamics. We begin by training it using a Proportional Derivative (PD) controller as a supervisor. We then make clinically relevant changes to the dynamics of the arm and test the actor-critic’s ability to adapt without supervision in a reasonable number of episodes. Finally, we devise methods for achieving both rapid learning and long-term stability. PMID:20689654

Application of the Actor-Critic Architecture to Functional Electrical Stimulation Control of a Human Arm.

PubMed

Thomas, Philip; Branicky, Michael; van den Bogert, Antonie; Jagodnik, Kathleen

2009-01-01

Clinical tests have shown that the dynamics of a human arm, controlled using Functional Electrical Stimulation (FES), can vary significantly between and during trials. In this paper, we study the application of the actor-critic architecture, with neural networks for the both the actor and the critic, as a controller that can adapt to these changing dynamics of a human arm. Development and tests were done in simulation using a planar arm model and Hill-based muscle dynamics. We begin by training it using a Proportional Derivative (PD) controller as a supervisor. We then make clinically relevant changes to the dynamics of the arm and test the actor-critic's ability to adapt without supervision in a reasonable number of episodes. Finally, we devise methods for achieving both rapid learning and long-term stability.

Stability of Chronic Hepatitis-Related Parameters in Serum Samples After Long-Term Storage.

PubMed

Yu, Rentao; Dan, Yunjie; Xiang, Xiaomei; Zhou, Yi; Kuang, Xuemei; Yang, Ge; Tang, Yulan; Liu, Mingdong; Kong, Weilong; Tan, Wenting; Deng, Guohong

2017-06-01

Serum samples are widely used in clinical research, but a comprehensive research of the stability of parameters relevant to chronic hepatitis and the effect of a relatively long-term (up to 10 years) storage on the stability have rarely been studied. To investigate the stability of chronic hepatitis-related parameters in serum samples after long-term storage. The storage stability of common clinical parameters such as total bile acid (TBA), total bilirubin (TBIL), potassium, cholesterol, and protein parameters such as alanine aminotransferase (ALT), creatine kinase (CK), γ-glutamyltransferase (GGT), albumin, high-density lipoprotein (HDL) and also hepatitis B virus (HBV) DNA, hepatitis C virus (HCV) RNA, hepatitis B surface antigen (HBsAg), and chemokine (C-X-C motif) ligand 10 (CXCL10) were tested in serum samples after storing at -20°C or -70°C for 1, 2, 3, 7, 8, and 10 years. Levels of TBA, TBIL, and protein parameters such as ALT, CK, GGT, HDL, and HBsAg decreased significantly, but levels of potassium and cholesterol increased significantly after long-term storage, whereas blood glucose and triglycerides were stable during storage. HBV DNA remained stable at -70°C but changed at -20°C, whereas HCV RNA was stable after 1-, 2-, and 3-year storage. CXCL10 was still detectable after 8-year storage. Low temperatures (-70°C/80°C) are necessary for storage of serum samples in chronic hepatitis B research after long-term storage.

Influence of press-fit parameters on the primary stability of uncemented femoral resurfacing implants.

PubMed

Gebert, A; Peters, J; Bishop, N E; Westphal, F; Morlock, M M

2009-01-01

Primary stability is essential to the success of uncemented prostheses. It is strongly influenced by implantation technique, implant design and bone quality. The goal of this study was to investigate the effect of press-fit parameters on the primary stability of uncemented femoral head resurfacing prostheses. An in vitro study with human specimens and prototype implants (nominal radial interference 170 and 420 microm) was used to investigate the effect of interference on primary stability. A finite element model was used to assess the influence of interference, friction between implant and bone, and bone quality. Primary stability was represented by the torque capacity of the implant. The model predicted increasing stability with actual interference, bone quality and friction coefficient; plastic deformation of the bone began at interferences of less than 100 microm. Experimentally, however, stability was not related to interference. This may be due to abrasion or the collapse of trabecular bone structures at higher interferences, which could not be captured by the model. High nominal interferences as tested experimentally appear unlikely to result in improved stability clinically. An implantation force of about 2,500 N was estimated to be sufficient to achieve a torque capacity of about 30 N m with a small interference (70 microm).

Preclinical evaluation of a new, stabilized neurotensin(8--13) pseudopeptide radiolabeled with (99m)tc.

PubMed

García-Garayoa, Elisa; Bläuenstein, Peter; Bruehlmeier, Matthias; Blanc, Alain; Iterbeke, Koen; Conrath, Peter; Tourwé, Dirk; Schubiger, P August

2002-03-01

The rapid degradation of neurotensin (NT) limits its clinical use in cancer imaging and therapy. Thus, a new NT(8--13) pseudopeptide, NT-VIII, was synthesized. Some changes were introduced in the sequence of NT(8--13) to stabilize the molecule against enzymatic degradation: Arg(8) was N-methylated, and Lys and Tle replaced Arg(9) and Ile(12), respectively. Finally, (NalphaHis)Ac was coupled to the N-terminus for (99m)Tc(CO)(3) labeling. This peptide was characterized both in vitro and in vivo. The new analog was labeled with (99m)Tc(CO)(3). Its metabolic stability was analyzed both in human plasma and in HT-29 cells. Binding properties, receptor downregulation, and internalization were tested with HT-29 cells. Biodistribution was evaluated in nude mice with HT-29 xenografts. (99m)Tc(CO)(3)NT-VIII showed a high stability in plasma, where most of the peptide remained intact after 24 h of incubation at 37 degreesC. However, the degradation in HT-29 cells was more rapid (46% of intact (99m)Tc(CO)(3)NT-VIII after 24 h at 37 degreesC). Binding to NT1 receptors (NTR1) was saturable and specific. Scatchard analysis showed a high affinity for (99m)Tc(CO)(3)NT-VIII, with a dissociation constant similar to (125)I-NT (1.8 vs. 1.6 nmol/L). After interacting with NTR1, (99m)Tc(CO)(3)NT-VIII was rapidly internalized, with more than 90% internalized after 30 min. It also distributed and cleared rapidly in nude mice bearing HT-29 xenografts. The highest rates of accumulation were found in kidney and tumor at all time points tested. Tumor uptake was highly specific because it could be blocked by coinjection with a high dose of (NalphaHis)Ac-NT(8--13). Tumors were clearly visualized in scintigraphy images. The changes that were introduced stabilized the molecule against enzymatic degradation without affecting binding properties. Moreover, the increase in stability enhanced tumor uptake, making this derivative a promising candidate for clinical use.

Biochemical phenotypes to discriminate microbial subpopulations and improve outbreak detection.

PubMed

Galar, Alicia; Kulldorff, Martin; Rudnick, Wallis; O'Brien, Thomas F; Stelling, John

2013-01-01

Clinical microbiology laboratories worldwide constitute an invaluable resource for monitoring emerging threats and the spread of antimicrobial resistance. We studied the growing number of biochemical tests routinely performed on clinical isolates to explore their value as epidemiological markers. Microbiology laboratory results from January 2009 through December 2011 from a 793-bed hospital stored in WHONET were examined. Variables included patient location, collection date, organism, and 47 biochemical and 17 antimicrobial susceptibility test results reported by Vitek 2. To identify biochemical tests that were particularly valuable (stable with repeat testing, but good variability across the species) or problematic (inconsistent results with repeat testing), three types of variance analyses were performed on isolates of K. pneumonia: descriptive analysis of discordant biochemical results in same-day isolates, an average within-patient variance index, and generalized linear mixed model variance component analysis. 4,200 isolates of K. pneumoniae were identified from 2,485 patients, 32% of whom had multiple isolates. The first two variance analyses highlighted SUCT, TyrA, GlyA, and GGT as "nuisance" biochemicals for which discordant within-patient test results impacted a high proportion of patient results, while dTAG had relatively good within-patient stability with good heterogeneity across the species. Variance component analyses confirmed the relative stability of dTAG, and identified additional biochemicals such as PHOS with a large between patient to within patient variance ratio. A reduced subset of biochemicals improved the robustness of strain definition for carbapenem-resistant K. pneumoniae. Surveillance analyses suggest that the reduced biochemical profile could improve the timeliness and specificity of outbreak detection algorithms. The statistical approaches explored can improve the robust recognition of microbial subpopulations with routinely available biochemical test results, of value in the timely detection of outbreak clones and evolutionarily important genetic events.

Minimizing Postsampling Degradation of Peptides by a Thermal Benchtop Tissue Stabilization Method

PubMed Central

Segerström, Lova; Gustavsson, Jenny

2016-01-01

Enzymatic degradation is a major concern in peptide analysis. Postmortem metabolism in biological samples entails considerable risk for measurements misrepresentative of true in vivo concentrations. It is therefore vital to find reliable, reproducible, and easy-to-use procedures to inhibit enzymatic activity in fresh tissues before subjecting them to qualitative and quantitative analyses. The aim of this study was to test a benchtop thermal stabilization method to optimize measurement of endogenous opioids in brain tissue. Endogenous opioid peptides are generated from precursor proteins through multiple enzymatic steps that include conversion of one bioactive peptide to another, often with a different function. Ex vivo metabolism may, therefore, lead to erroneous functional interpretations. The efficacy of heat stabilization was systematically evaluated in a number of postmortem handling procedures. Dynorphin B (DYNB), Leu-enkephalin-Arg6 (LARG), and Met-enkephalin-Arg6-Phe7 (MEAP) were measured by radioimmunoassay in rat hypothalamus, striatum (STR), and cingulate cortex (CCX). Also, simplified extraction protocols for stabilized tissue were tested. Stabilization affected all peptide levels to varying degrees compared to those prepared by standard dissection and tissue handling procedures. Stabilization increased DYNB in hypothalamus, but not STR or CCX, whereas LARG generally decreased. MEAP increased in hypothalamus after all stabilization procedures, whereas for STR and CCX, the effect was dependent on the time point for stabilization. The efficacy of stabilization allowed samples to be left for 2 hours in room temperature (20°C) without changes in peptide levels. This study shows that conductive heat transfer is an easy-to-use and efficient procedure for the preservation of the molecular composition in biological samples. Region- and peptide-specific critical steps were identified and stabilization enabled the optimization of tissue handling and opioid peptide analysis. The result is improved diagnostic and research value of the samples with great benefits for basic research and clinical work. PMID:27007059

Stability study of carboplatin infusion solutions in 0.9% sodium chloride in polyvinyl chloride bags.

PubMed

Myers, Alan L; Zhang, Yang-Ping; Kawedia, Jitesh D; Trinh, Van A; Tran, Huyentran; Smith, Judith A; Kramer, Mark A

2016-02-01

Carboplatin is a platinum-containing compound with efficacy against various malignancies. The physico-chemical stability of carboplatin in dextrose 5% water (D5W) has been thoroughly studied; however, there is a paucity of stability data in clinically relevant 0.9% sodium chloride infusion solutions. The manufacturer's limited stability data in sodium chloride solutions hampers the flexibility of carboplatin usage in oncology patients. Hence, the purpose of this study is to determine the physical and chemical stability of carboplatin-sodium chloride intravenous solutions under different storage conditions. The physico-chemical stability of 0.5 mg/mL, 2.0 mg/mL, and 4.0 mg/mL carboplatin-sodium chloride solutions prepared in polyvinyl chloride bags was determined following storage at room temperature under ambient fluorescent light and under refrigeration in the dark. Concentrations of carboplatin were measured at predetermined time points up to seven days using a stability-indicating high-performance liquid chromatography method. All tested solutions were found physically stable for at least seven days. The greatest chemical stability was observed under refrigerated storage conditions. At 4℃, all tested solutions were found chemically stable for at least seven days, with nominal losses of ≤6%. Following storage at room temperature exposed to normal fluorescent light, the chemical stability of 0.5 mg/mL, 2.0 mg/mL, and 4.0 mg/mL solutions was three days, five days, and seven days, respectively. The extended physico-chemical stability of carboplatin prepared in sodium chloride reported herein permits advance preparation of these admixtures, facilitating pharmacy utility and operations. Since no antibacterial preservative is contained within these carboplatin solutions, we recommend storage, when prepared under specified aseptic conditions, no greater than 24 h at room temperature or three days under refrigeration. © The Author(s) 2014.

Assessing the correlation between mutant rhodopsin stability and the severity of retinitis pigmentosa

PubMed Central

McKeone, Richard; Wikstrom, Matthew; Kiel, Christina

2014-01-01

Purpose Following a previous study that demonstrated a correlation between rhodopsin stability and the severity of retinitis pigmentosa (RP), we investigated whether predictions of severity can be improved with a regional analysis of this correlation. The association between changes to the stability of the protein and the relative amount of rhodopsin reaching the plasma membrane was assessed. Methods Crystallography-based estimations of mutant rhodopsin stability were compared with descriptions in the scientific literature of the visual function of mutation carriers to determine the extent of associations between rhodopsin stability and clinical phenotype. To test the findings of this analysis, three residues of a green fluorescent protein (GFP) tagged rhodopsin plasmid were targeted with site-directed random mutagenesis to generate mutant variants with a range of stability changes. These plasmids were transfected into HEK-293 cells, and then flow cytometry was used to measure rhodopsin on the cells’ plasma membrane. The GFP signal was used to measure the ratio between this membrane-bound rhodopsin and total cellular rhodopsin. FoldX stability predictions were then compared with the surface staining data and clinical data from the database to characterize the relationship between rhodopsin stability, the severity of RP, and the expression of rhodopsin at the cell surface. Results There was a strong linear correlation between the scale of the destabilization of mutant variants and the severity of retinal disease. A correlation was also seen in vitro between stability and the amount of rhodopsin at the plasma membrane. Rhodopsin is drastically reduced on the surface of cells transfected with variants that differ in their inherent stability from the wild-type by more than 2 kcal/mol. Below this threshold, surface levels are closer to those of the wild-type. Conclusions There is a correlation between the stability of rhodopsin mutations and disease severity and levels of membrane-bound rhodopsin. Measuring membrane-bound rhodopsin with flow cytometry could improve prognoses for poorly characterized mutations and could provide a platform for measuring the effectiveness of treatments. PMID:24520188

46 CFR 170.085 - Information required before a stability test.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 46 Shipping 7 2013-10-01 2013-10-01 false Information required before a stability test. 170.085 Section 170.085 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) SUBDIVISION AND STABILITY STABILITY REQUIREMENTS FOR ALL INSPECTED VESSELS Plan Approval § 170.085 Information required before a stability test. If a stability test is t...

Next-generation negative symptom assessment for clinical trials: validation of the Brief Negative Symptom Scale.

PubMed

Strauss, Gregory P; Keller, William R; Buchanan, Robert W; Gold, James M; Fischer, Bernard A; McMahon, Robert P; Catalano, Lauren T; Culbreth, Adam J; Carpenter, William T; Kirkpatrick, Brian

2012-12-01

The current study examined the psychometric properties of the Brief Negative Symptom Scale (BNSS), a next-generation rating instrument developed in response to the NIMH sponsored consensus development conference on negative symptoms. Participants included 100 individuals with a DSM-IV diagnosis of schizophrenia or schizoaffective disorder who completed a clinical interview designed to assess negative, positive, disorganized, and general psychiatric symptoms, as well as functional outcome. A battery of anhedonia questionnaires and neuropsychological tests were also administered. Results indicated that the BNSS has excellent internal consistency and temporal stability, as well as good convergent and discriminant validity in its relationships with other symptom rating scales, functional outcome, self-reported anhedonia, and neuropsychological test scores. Given its brevity (13-items, 15-minute interview) and good psychometric characteristics, the BNSS can be considered a promising new instrument for use in clinical trials. Copyright © 2012 Elsevier B.V. All rights reserved.

Impact of syncope on quality of life: validation of a measure in patients undergoing tilt testing.

PubMed

Nave-Leal, Elisabete; Oliveira, Mário; Pais-Ribeiro, José; Santos, Sofia; Oliveira, Eunice; Alves, Teresa; Cruz Ferreira, Rui

2015-03-01

Recurrent syncope has a significant impact on quality of life. The development of measurement scales to assess this impact that are easy to use in clinical settings is crucial. The objective of the present study is a preliminary validation of the Impact of Syncope on Quality of Life questionnaire for the Portuguese population. The instrument underwent a process of translation, validation, analysis of cultural appropriateness and cognitive debriefing. A population of 39 patients with a history of recurrent syncope (>1 year) who underwent tilt testing, aged 52.1 ± 16.4 years (21-83), 43.5% male, most in active employment (n=18) or retired (n=13), constituted a convenience sample. The resulting Portuguese version is similar to the original, with 12 items in a single aggregate score, and underwent statistical validation, with assessment of reliability, validity and stability over time. With regard to reliability, the internal consistency of the scale is 0.9. Assessment of convergent and discriminant validity showed statistically significant results (p<0.01). Regarding stability over time, a test-retest of this instrument at six months after tilt testing with 22 patients of the sample who had not undergone any clinical intervention found no statistically significant changes in quality of life. The results indicate that this instrument is of value for assessing quality of life in patients with recurrent syncope in Portugal. Copyright © 2014 Sociedade Portuguesa de Cardiologia. Published by Elsevier España. All rights reserved.

Poster - Thur Eve - 10: Long term stability of VMAT quality assurance parameters using an EPID.

PubMed

Pekar, J; Diamond, K R

2012-07-01

The rapidly growing use of volumetric modulated arc therapy (VMAT) treatments in radiation therapy calls for a quantitative, automated, and reliable quality assurance (QA) procedure that can be used routinely in the clinical setting. In this work, we present a series VMAT QA procedures used to assess dynamic multi-leaf collimator (MLC) positional accuracy, variable dose-rate accuracy, and MLC leaf speed accuracy. The QA procedures were performed using amorphous silicon electronic portal imaging devices (EPID) to determine the long term stability of the measured parameters on two Varian linear accelerators. The measurements were repeated weekly on both linear accelerators for a period of three months and the EPID images were analyzed using custom Matlab software. The results of the picket fence tests indicate that MLC leaf positions can be identified to within 0.11 mm and 0.15 mm for static gantry delivery and VMAT delivery respectively. In addition, the dose-rate, gantry speed and MLC leaf speed tests both show very good stability over the measurement period. The measurements thus far, suggest that a number of the dosimetry tests may be suitable for quarterly QA for Varian iX and Trilogy linacs. However, additional measurements are required to confirm the frequency with which each test is required for safe and reliable VMAT delivery at our centre. © 2012 American Association of Physicists in Medicine.

A Novel Clinically Translatable Fluorescent Nanoparticle for Targeted Molecular Imaging of Tumors in Living Subjects

PubMed Central

Gao, Jinhao; Chen, Kai; Luong, Richard; Bouley, Donna M.; Mao, Hua; Qiao, Tiecheng; Gambhir, Sanjiv S.; Cheng, Zhen

2011-01-01

The use of quantum dots (QDs) in biomedical research has grown tremendously, yet successful examples of clinical applications are absent due to many clinical concerns. Here, we report on a new type of stable and biocompatible dendron-coated InP/ZnS core/shell QDs as a clinically translatable nanoprobe for molecular imaging applications. The QDs (QD710-Dendron) were demonstrated to hold several significant features: near-infrared (NIR) emission, high stability in biological media, suitable size with possible renal clearance and ability of extravasation. More importantly, a pilot mouse toxicity study confirmed that QD710-Dendron lacks significant toxicity at the doses tested. The acute tumor uptake of QD710-Dendron resulted in good contrast from the surrounding non-tumorous tissues, indicating the possibility of passive targeting of the QDs. The highly specific targeting of QD710-Dendron-RGD2 to integrin αvβ3–positive tumor cells resulted in high tumor uptake and long retention of the nanoprobe at tumor sites. In summary, QD710-Dendron and RGD modified nanoparticles demonstrate small size, high stability, biocompatibility, favorable in vivo pharmacokinetics, and successful tumor imaging properties. These features satisfy the requirements for clinical translation and should promote efforts to further investigate the possibility of using QD710-Dendron based nanoprobes in the clinical setting in the near future. PMID:22172022

A novel clinically translatable fluorescent nanoparticle for targeted molecular imaging of tumors in living subjects.

PubMed

Gao, Jinhao; Chen, Kai; Luong, Richard; Bouley, Donna M; Mao, Hua; Qiao, Tiecheng; Gambhir, Sanjiv S; Cheng, Zhen

2012-01-11

The use of quantum dots (QDs) in biomedical research has grown tremendously, yet successful examples of clinical applications are absent due to many clinical concerns. Here, we report on a new type of stable and biocompatible dendron-coated InP/ZnS core/shell QD as a clinically translatable nanoprobe for molecular imaging applications. The QDs (QD710-Dendron) were demonstrated to hold several significant features: near-infrared (NIR) emission, high stability in biological media, suitable size with possible renal clearance, and ability of extravasation. More importantly, a pilot mouse toxicity study confirmed that QD710-Dendron lacks significant toxicity at the doses tested. The acute tumor uptake of QD710-Dendron resulted in good contrast from the surrounding nontumorous tissues, indicating the possibility of passive targeting of the QDs. The highly specific targeting of QD710-Dendron-RGD(2) to integrin α(v)β(3)-positive tumor cells resulted in high tumor uptake and long retention of the nanoprobe at tumor sites. In summary, QD710-Dendron and RGD-modified nanoparticles demonstrate small size, high stability, biocompatibility, favorable in vivo pharmacokinetics, and successful tumor imaging properties. These features satisfy the requirements for clinical translation and should promote efforts to further investigate the possibility of using QD710-Dendron-based nanoprobes in the clinical setting in the near future. © 2011 American Chemical Society

[Mechanical testing of implant properties of thoracoscopic implantation of ventral spinal stabilizing systems. Comparative study with the ISO/DIS 12189-2 corpectomy model and an improved synthetic model].

PubMed

Grupp, T M; Beisse, R; Potulski, M; Marnay, T; Beger, J; Blömer, W

2002-04-01

A new modular anterior fixation system MACS TL (modular anterior construct system for the thoracic and lumbar spine) has been developed for use in thoracoscopic spondylodesis. This system demonstrates high angular stability and meets the surgical requirements for an endoscopic approach. The objective of the current study was fatigue testing of the MACS TL implant system using a corpectomy model according to ISO/DIS 12189-2 and a synthetic model recently developed by Kotani et al. [6]. The MACS TL system demonstrated good mechanical properties with a high stiffness compared to the published data reviewed. The importance of dynamic testing in a corpectomy model has been demonstrated by comparing the MACS TL plate system with an early prototype, which has not yet been clinically evaluated. The corpectomy model according to Kotani et al. offers an interesting alternative to the ISO/DIS 12189-2 test method for asymmetrically designed and antero-laterally positioned spinal implants due to the unconstrained ball joint.

Molecular markers for colorectal cancer screening

PubMed Central

Dickinson, Brandon T.; Kisiel, John; Ahlquist, David A.; Grady, William M.

2016-01-01

Colorectal cancer (CRC), although a significant cause of morbidity and mortality worldwide, has seen a declining incidence and mortality in countries with programmatic screening. Fecal occult blood testing (FOBT) and endoscopic approaches are the predominant screening methods currently. The discovery of the adenoma→carcinoma sequence and a greater understanding of the genetic and epigenetic changes that drive the formation of CRC have contributed to innovative research to identify molecular markers for highly accurate, non-invasive screening tests for CRC. DNA, proteins, messenger RNA, and micro-RNA have all been evaluated. The observation of tumor cell exfoliation into the mucocellular layer of the colonic epithelium and proven stability of DNA in a harsh stool environment make stool DNA a particularly promising marker. The development of a clinically useful stool DNA test has required numerous technical advances, including optimization in DNA stabilization, the development of assays with high analytical sensitivity, and the identification of specific and broadly informative molecular markers. A multi-target stool DNA (MT-sDNA) test, which combines both mutant and methylated DNA markers and a fecal immunochemical test (FIT), recently performed favorably in a large cross-sectional validation study and has been approved by the US Food and Drug Administration (FDA) for the screening of asymptomatic, average risk individuals. The ultimate way in which molecular marker screening assays will be used in clinical practice will require additional studies to determine optimal screening intervals, factors affecting compliance, management of false positive results, and the use of these assays in high-risk populations, as well as other considerations. PMID:25994221

[Validation of the Cognitive Impairment in Psychiatry (SCIP-S) Screen Scale in Patients with Bipolar Disorder I].

PubMed

Castaño Ramírez, Oscar Mauricio; Martínez Ramírez, Yeferson André; Marulanda Mejía, Felipe; Díaz Cabezas, Ricardo; Valderrama Sánchez, Lenis Alexandra; Varela Cifuentes, Vilma; Aguirre Acevedo, Daniel Camilo

2015-01-01

The Spanish version of the cognitive impairment in psychiatry scale screening scale has been developed as a response to the needs arising in clinical practice during the evaluation of mental illness patients, but the performance is not known in the Colombian population with bipolar disorder I. This paper tries to establish construct validity and stability of the scale in patients with bipolar disorder I in the city of Manizales. Construct validity was estimated by comparing the measurement in two divergent groups, a control group and a group with bipolar disorder I. It was also compared to a Neuropsychological battery measuring the same scale domains. The correlation between each one of the sub-tests of the scale and stability was evaluated through the reliability test-retest in the group with bipolar disorder I. The scale showed discriminatory capacity in cognitive functioning between the control group and the group with bipolar disorder I. The correlation with the neuropsychological battery was estimated by the Spearman test showing results between 0.36 and 0.77, and the correlation between each sub-test of the scale showed correlations between 0.39 and 0.72. Test-retest was measured with the intraclass correlation coefficient (ICC) and their values were between 0.77 and 0.91. The Spanish version of screening scale in the cognitive disorder in psychiatry shows acceptable validity and reliability as a measurement tool in clinical psychiatric practice. Copyright © 2014 Asociación Colombiana de Psiquiatría. Publicado por Elsevier España. All rights reserved.

Biomechanical Analysis of All-Inside, Arthroscopic Suture Repair Versus Extensor Retinaculum Capsulorrhaphy for Triangular Fibrocartilage Complex Tears With Instability.

PubMed

Patel, Amar A; Alhandi, Ali A; Milne, Edward; Dy, Christopher J; Latta, Loren L; Ouellette, E Anne

2016-03-01

To assess ulnocarpal joint stability after treatment of a peripheral triangular fibrocartilage complex (TFCC) injury with all-inside arthroscopic suture repair (SR), extensor retinaculum capsulorrhaphy with the Herbert sling (HS), and a combination of both (SR+HS). Twelve fresh-frozen, age-matched, upper-extremity specimens intact from the distal humerus were prepared. Nondestructive mechanical testing was performed to assess native ulnocarpal joint stability and load-displacement curves were recorded. A peripheral, ulnar-sided TFCC injury was created with arthroscopic assistance, and mechanical testing was performed. Each specimen was treated with SR or HS and testing was repeated. The 6 specimens treated with SR were then treated with HS (SR+HS), and testing was repeated. We used paired Student t tests for statistical analysis within cohorts. For all cohorts, there was an average increase in ulnar translation after the creation of a peripheral TFCC injury and an average decrease after repair. Herbert sling decreased translation by 21%, SR decreased translation by 12%, and SR+HS decreased translation by 26%. Suture repair plus HS and HS reduce ulnar translation the most after a peripheral TFCC injury, followed by SR alone. Ulnocarpal joint stability should be assessed clinically in patients with peripheral TFCC injury, and consideration should be made for using extensor capsulorrhaphy in isolation or as an adjunct to SR as a treatment option. Copyright © 2016 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.

The effectiveness of core stabilization exercise in adolescent idiopathic scoliosis: A randomized controlled trial.

PubMed

Gür, Gözde; Ayhan, Cigdem; Yakut, Yavuz

2017-06-01

Core stabilization training is used to improve postural balance in musculoskeletal problems. The purpose of this study was to investigate the effectiveness of stabilization training in adolescent idiopathic scoliosis. A randomized controlled trial, pretest-posttest design. In total, 25 subjects with adolescent idiopathic scoliosis were randomly divided into two groups: stabilization group ( n = 12) and control group ( n = 13). The stabilization group received core stabilization in addition to traditional rehabilitation, and the control group received traditional rehabilitation for 10 weeks. Assessment included Cobb's angle on radiograph, apical vertebral rotation in Adam's test, trunk asymmetry (Posterior Trunk Symmetry Index), cosmetic trunk deformity (Trunk Appearance Perception Scale), and quality of life (Scoliosis Research Society-22 questionnaire). Inter-group comparisons showed significantly greater improvements in the mean change in lumbar apical vertebral rotation degree and the pain domain of Scoliosis Research Society-22 in the stabilization group than those in the control group ( p < 0.05). No significant differences were observed for other measurements between the groups; however, trends toward greater improvement were observed in the stabilization group. Core stabilization training in addition to traditional exercises was more effective than traditional exercises alone in the correction of vertebral rotation and reduction of pain in adolescent idiopathic scoliosis. Clinical relevance Stabilization exercises are more effective in reducing rotation deformity and pain than traditional exercises in the conservative rehabilitation of adolescent idiopathic scoliosis. These improvements suggest that stabilization training should be added to rehabilitation programs in adolescent idiopathic scoliosis.

Effect of PEG molecular weight on stability, T₂ contrast, cytotoxicity, and cellular uptake of superparamagnetic iron oxide nanoparticles (SPIONs).

PubMed

Park, Yoonjee C; Smith, Jared B; Pham, Tuan; Whitaker, Ragnhild D; Sucato, Christopher A; Hamilton, James A; Bartolak-Suki, Elizabeth; Wong, Joyce Y

2014-07-01

Superparamagnetic iron oxide nanoparticles (SPIONs) are currently unavailable as MRI contrast agents for detecting atherosclerosis in the clinical setting because of either low signal enhancement or safety concerns. Therefore, a new generation of SPIONs with increased circulation time, enhanced image contrast, and less cytotoxicity is essential. In this study, monodisperse SPIONs were synthesized and coated with polyethylene glycol (PEG) of varying molecular weights. The resulting PEGylated SPIONs were characterized, and their interactions with vascular smooth muscle cells (VSMCs) were examined. SPIONs were tested at different concentrations (100 and 500 ppm Fe) for stability, T2 contrast, cytotoxicity, and cellular uptake to determine an optimal formulation for in vivo use. We found that at 100 ppm Fe, the PEG 2K SPIONs showed adequate stability and magnetic contrast, and exhibited the least cytotoxicity and nonspecific cellular uptake. An increase in cell viability was observed when the SPION-treated cells were washed with PBS after 1h incubation compared to 5 and 24h incubation without washing. Our investigation provides insight into the potential safe application of SPIONs in the clinic. Copyright © 2014 Elsevier B.V. All rights reserved.

[The biomechanics of hyperextension injuries of the subaxial cervical spine].

PubMed

Stein, G; Meyer, C; Ingenhoff, L; Bredow, J; Müller, L P; Eysel, P; Schiffer, G

2017-07-01

Hyperextension injuries of the subaxial cervical spine are potentially hazardous due to relevant destabilization. Depending on the clinical condition, neurologic or vascular damage may occur. Therefore an exact knowledge of the factors leading to destabilization is essential. In a biomechanical investigation, 10 fresh human cadaver cervical spine specimens were tested in a spine simulator. The tested segments were C4 to 7. In the first step, physiologic motion was investigated. Afterwards, the three steps of injury were dissection of the anterior longitudinal ligament, removal of the intervertebral disc/posterior longitudinal ligament, and dissection of the interspinous ligaments/ligamentum flavum. After each step, the mobility was determined. Regarding flexion and extension, an increase in motion of 8.36 % after the first step, 90.45 % after the second step, and 121.67 % after the last step was observed. Testing of lateral bending showed an increase of mobility of 7.88 %/27.48 %/33.23 %; axial rotation increased by 2.87 %/31.16 %/45.80 %. Isolated dissection of the anterior longitudinal ligament led to minor destabilization, whereas the intervertebral disc has to be seen as a major stabilizer of the cervical spine. Few finite-element studies showed comparable results. If a transfer to clinical use is undertaken, an isolated rupture of the anterior longitudinal ligament can be treated without surgical stabilization.

[Interface compatibility between tooth-like yttria-stabilized tetragonal zirconia polycrystal by adding rare-earth oxide and Vita VM9 veneering porcelain].

PubMed

Gao, Yan; Zhang, Fu-qiang; He, Fan

2011-10-01

To evaluate the interface compatibility between tooth-like yttria-stabilized tetragonal zirconia polycrystal(Y-TZP) by adding rare-earth oxide and Vita VM9 veneering porcelain. Six kinds(S1,S2,S3,S4,S5,S6) of tooth-like yttria stabilized tetragonal zirconia polycrystal were made by introducing internal colorating technology to detect the thermal shock resistance and interface bonding strength with Vita VM9 Bsaedentin. Statistical analysis was performed using SAS6.12 software package. There was no gap between the layers via hot shocking test.The shear bonding strength between Y-TZP and VitaVM9 was higher and the value was (36.03±3.82) to (37.98±4.89) MPa. By adding rare-earth oxide to yttria-stabilized tetragonal zirconia polycrystal ,better compatibility between the layer (TZP and Vita VM9) can be formed which is of better interface integrate and available for clinical applications.

Can an anti-gravity treadmill improve stability of children with cerebral palsy?

PubMed

Birgani, P M; Ashtiyani, M; Rasooli, A; Shahrokhnia, M; Shahrokhi, A; Mirbagheri, M M

2016-08-01

We aimed to study the effects of an anti-gravity treadmill (AlterG) training on balance and postural stability in children with cerebral palsy (CP). AlterG training was performed 3 days/week for 8 weeks, with up to 45 minutes of training per session. The subject was evaluated before and after the 8-week training. The effects of training on the balance and postural stability was evaluated based on the Romberg test that was performed by using a posturography device. The parameters quantifying Center-of-Pressure (CoP) were calculated using different analytical approaches including power spectral density and principal components analyses. All of the key parameters including the Stabilogram, the Fast Fourier Transform (FFT) Energy, the Eigenvectors, and the Eigenvalues of CoP were modified between 14%-84%. The results indicated that the balance features were improved substantially after training. The clinical implication is that the AlterG has the potential to effectively improve postural stability in children with cerebral palsy.

Stability of Self-Reported Arousal to Sexual Fantasies Involving Children in a Clinical Sample of Pedophiles and Hebephiles.

PubMed

Grundmann, Dorit; Krupp, Jurian; Scherner, Gerold; Amelung, Till; Beier, Klaus M

2016-07-01

In forensic research, there is a controversial discussion concerning the changeability or stability of pedophilia. Seto (2012) conceptualized pedophilia as a sexual age orientation characterized by an early onset, correlations with sexual and romantic behavior, and stability over time. However, empirical data are sparse and are mostly based on samples of detected offenders. The present study examined self-reported arousal to sexual fantasies involving children in a clinical sample of pedo-/hebephiles. In Study 1, retrospective self-reports on the age of onset and duration of sexual interest in minors were examined. In Study 2, the stability and variability of self-reported arousal to sexual fantasies involving children were evaluated prospectively. Non-prosecuted self-identifying pedo-/hebephilic men seeking professional help were recruited within the Berlin Prevention Project Dunkelfeld. Between 2005 and 2013, 494 participants completed the intake assessment. Self-reported data were collected via questionnaire focusing on sexual arousal to fantasies during masturbation involving prepubescent and/or early pubescent minors. Subsequent assessments of sexual arousal were obtained for 121 of the participants. The average time between the first and last assessment was approximately 29 months. Spearman's correlation coefficients examined the between-group rank-order and Wilcoxon signed-rank tests examined the within-individual mean-level stability. The majority of subjects reported an early onset of their pedo-/hebephilic sexual arousal. The rank-order stability was medium to high. Over the investigated period, the majority of subjects showed no or only minimal decrease or increase of self-reported sexual arousal. These results suggested that sexual arousal to fantasies involving prepubescent and/or early pubescent children is stable. Furthermore, the results support the conceptualization of pedo-/hebephilia as a sexual age orientation in men.

Selecting clinical quality indicators for laboratory medicine.

PubMed

Barth, Julian H

2012-05-01

Quality in laboratory medicine is often described as doing the right test at the right time for the right person. Laboratory processes currently operate under the oversight of an accreditation body which gives confidence that the process is good. However, there are aspects of quality that are not measured by these processes. These are largely focused on ensuring that the most clinically appropriate test is performed and interpreted correctly. Clinical quality indicators were selected through a two-phase process. Firstly, a series of focus groups of clinical scientists were held with the aim of developing a list of quality indicators. These were subsequently ranked in order by an expert panel of primary and secondary care physicians. The 10 top indicators included the communication of critical results, comprehensive education to all users and adequate quality assurance for point-of-care testing. Laboratories should ensure their tests are used to national standards, that they have clinical utility, are calibrated to national standards and have long-term stability for chronic disease management. Laboratories should have error logs and demonstrate evidence of measures introduced to reduce chances of similar future errors. Laboratories should make a formal scientific evaluation of analytical quality. This paper describes the process of selection of quality indicators for laboratory medicine that have been validated sequentially by deliverers and users of the service. They now need to be converted into measureable variables related to outcome and validated in practice.

Influence of surface treatment of yttria-stabilized tetragonal zirconia polycrystal with hot isostatic pressing on cyclic fatigue strength.

PubMed

Iijima, Toshihiko; Homma, Shinya; Sekine, Hideshi; Sasaki, Hodaka; Yajima, Yasutomo; Yoshinari, Masao

2013-01-01

Hot isostatic pressing processed yttria-stabilized tetragonal zirconia polycrystal (HIP Y-TZP) has the potential for application to implants due to its high mechanical performance. The aim of this study was to investigate the influence of surface treatment of HIP Y-TZP on cyclic fatigue strength. HIP Y-TZP specimens were subjected to different surface treatments. Biaxial flexural strength was determined by both static and cyclic fatigue testing. In the cyclic fatigue test, the load was applied at a frequency of 10 Hz for 10(6) cycles in distilled water at 37°C. The surface morphology, roughness, and crystal phase of the surfaces were also evaluated. The cyclic fatigue strength (888 MPa) of HIP Y-TZP with sandblasting and acid-etching was more than twice that of Y-TZP as specified in ISO 13356 for surgical implants (320 MPa), indicating the clinical potential of this material.

PFAT5 and the Evolution of Lipid Admixture Stability.

PubMed

Klang, Mark G

2015-09-01

PFAT5 is defined by United States Pharmacopeia Chapter 729 as follows: the "percentage of fat residing in globules larger than 5 µm (PFAT5) for a given lipid injectable emulsion [is] not to exceed 0.05%." The unstable aggregates are trapped in lungs, liver, and the reticuloendothelial system. Large particles will accumulate in pulmonary capillaries, which are between 4 and 9 µm in diameter. Over the years, there has been an evolution of methods to characterize and define intravenous fat emulsion (IVFE) stability when combined as a total nutrient admixture (TNA). Many studies have claimed IVFE stability measuring mean particle size, zeta potential, and visual checks. Interestingly, none of the studies that claimed the TNA as stable identified an unstable one through testing. This report reviews those parameters and shows they were not a valid measure of lipid stability. The PFAT5 parameter has emerged as the only validated measure of lipid stability. There are clinical consequences of using lipids that exceed the PFAT5 limit. This parameter is applicable to both manufactured and compounded lipid preparations. The clinician should be aware of the limitations of much of the literature concerning the lipid stability assessment. More stability studies are needed using PFAT5 to identify the actual limits of TNA compounding. © 2015 American Society for Parenteral and Enteral Nutrition.

46 CFR 170.185 - Stability test preparations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 7 2010-10-01 2010-10-01 false Stability test preparations. 170.185 Section 170.185....185 Stability test preparations. The following preparations must be made before conducting a stability... of the vessel to be tested. (2) Date and location of the test. (3) Inclining weight data. (4...

Extended International Normalized Ratio testing intervals for warfarin-treated patients.

PubMed

Barnes, G D; Kong, X; Cole, D; Haymart, B; Kline-Rogers, E; Almany, S; Dahu, M; Ekola, M; Kaatz, S; Kozlowski, J; Froehlich, J B

2018-05-15

Essentials Warfarin typically requires International Normalized Ratio (INR) testing at least every 4 weeks. We implemented extended INR testing for stable warfarin patients in six anticoagulation clinics. Use of extended INR testing increased from 41.8% to 69.3% over the 3 year study. Use of extended INR testing appeared safe and effective. Background A previous single-center randomized trial suggested that patients with stable International Normalized Ratio (INR) values could safely receive INR testing as infrequently as every 12 weeks. Objective To test the success of implementation of an extended INR testing interval for stable warfarin patients in a practice-based, multicenter collaborative of anticoagulation clinics. Methods At six anticoagulation clinics, patients were identified as being eligible for extended INR testing on the basis of prior INR value stability and minimal warfarin dose changes between 2014 and 2016. We assessed the frequency with which anticoagulation clinic providers recommended an extended INR testing interval (> 5 weeks) to eligible patients. We also explored safety outcomes for eligible patients, including next INR values, bleeding events, and emergency department visits. Results At least one eligible period for extended INR testing was identified in 890 of 3362 (26.5%) warfarin-treated patients. Overall, the use of extended INR testing in eligible patients increased from 41.8% in the first quarter of 2014 to 69.3% in the fourth quarter of 2016. The number of subsequent out-of-range next INR values were similar between eligible patients who did and did not have an extended INR testing interval (27.3% versus 28.4%, respectively). The numbers of major bleeding events were not different between the two groups, but rates of clinically relevant non-major bleeding (0.02 per 100 patient-years versus 0.09 per 100 patient-years) and emergency department visits (0.07 per 100 patient-years versus 0.19 per 100 patient-years) were lower for eligible patients with extended INR testing intervals than for those with non-extended INR testing intervals. Conclusions Extended INR testing for stable warfarin patients can be successfully and safely implemented in diverse, practice-based anticoagulation clinic settings. © 2018 International Society on Thrombosis and Haemostasis.

The use of synthetic ligaments in the design of an enhanced stability total knee joint replacement.

PubMed

Stokes, Michael D; Greene, Brendan C; Pietrykowski, Luke W; Gambon, Taylor M; Bales, Caroline E; DesJardins, John D

2018-03-01

Current total knee replacement designs work to address clinically desired knee stability and range of motion through a balance of retained anatomy and added implant geometry. However, simplified implant geometries such as bearing surfaces, posts, and cams are often used to replace complex ligamentous constraints that are sacrificed during most total knee replacement procedures. This article evaluates a novel total knee replacement design that incorporates synthetic ligaments to enhance the stability of the total knee replacement system. It was hypothesized that by incorporating artificial cruciate ligaments into a total knee replacement design at specific locations and lengths, the stability of the total knee replacement could be significantly altered while maintaining active ranges of motion. The ligament attachment mechanisms used in the design were evaluated using a tensile test, and determined to have a safety factor of three with respect to expected ligamentous loading in vivo. Following initial computational modeling of possible ligament orientations, a physical prototype was constructed to verify the function of the design by performing anterior/posterior drawer tests under physiologic load. Synthetic ligament configurations were found to increase total knee replacement stability up to 94% compared to the no-ligament case, while maintaining total knee replacement flexion range of motion between 0° and 120°, indicating that a total knee replacement that incorporates synthetic ligaments with calibrated location and lengths should be able to significantly enhance and control the kinematic performance of a total knee replacement system.

Drilling the femoral tunnel during ACL reconstruction: transtibial versus anteromedial portal techniques.

PubMed

Tudisco, Cosimo; Bisicchia, Salvatore

2012-08-01

Incorrect bone tunnel position, particularly on the femoral side, is a frequent cause of failed anterior cruciate ligament reconstruction. Several studies have reported that drilling the femoral tunnel through the anteromedial portal allows a more anatomical placement on the lateral femoral condyle and higher knee stability than does transtibial reconstruction.In the current study, the femoral tunnel was drilled with transtibial (n=6) and anteromedial (n=6) portal techniques in 12 cadaveric knees. With appropriate landmarks inserted into bone tunnels, the direction and length of the tunnels were determined on anteroposterior and lateral radiographs. Knee stability was evaluated with a KT1000 arthrometer (MEDmetric Corporation, San Diego, California) and pivot shift test, comparing the pre- and postoperative values of both techniques. Finally, all knees were dissected to enhance vision of the insertion of the reconstructed ligament. The anteromedial portal technique led to better placement of the femoral tunnel in the coronal and sagittal planes, with higher knee stability according to the pivot shift test but not the KT1000 arthrometer. Anatomical and clinical results reported in the literature on transtibial and anteromedial portal techniques are controversial, but most of studies report better results with the anteromedial portal technique, especially regarding rotational stability. The current cadaveric study showed that the anteromedial portal technique provided better tunnel placement on the lateral femoral condyle in the coronal and sagittal planes, with an improvement in the rotational stability of the knee. Copyright 2012, SLACK Incorporated.

Physical and chemical stability of reconstituted and diluted dexrazoxane infusion solutions.

PubMed

Zhang, Yan-Ping; Myers, Alan L; Trinh, Van A; Kawedia, Jitesh D; Kramer, Mark A; Benjamin, Robert S; Tran, Hai T

2014-02-01

Dexrazoxane is used clinically to prevent anthracycline-associated cardiotoxicity. Hydrolysis of dexrazoxane prior to reaching the cardiac membranes severely hampers its mode of action; therefore, degradation during the preparation and administration of intravenous dexrazoxane admixtures demands special attention. Moreover, the ongoing national shortage of one dexrazoxane formulation in the United States has forced pharmacies to dispense other commercially available dexrazoxane products. However, the manufacturers' limited stability data restrict the flexibility of dexrazoxane usage in clinical practice. The aims of this study are to determine the physical and chemical stability of reconstituted and diluted solutions of two commercially available dexrazoxane formulations. The stability of two dexrazoxane products, brand and generic name, in reconstituted and intravenous solutions stored at room temperature without light protection in polyvinyl chloride bags was determined. The concentrations of dexrazoxane were measured at predetermined time points up to 24 h using a validated reversed phase high-performance liquid chromatography with ultraviolet detection assay. Brand (B-) and generic (G-) dexrazoxane products, reconstituted in either sterile water or 0.167 M sodium lactate (final concentration of 10 mg/mL), were found stable for at least to 8 h. Infusion solutions of B-dexrazoxane, prepared according to each manufacturer's directions, were stable for at least 24 h and 8 h at 1 mg/mL and 3 mg/mL, respectively. Infusion solutions of G-dexrazoxane, prepared in either 5% dextrose or 0.9% sodium chloride following the manufacturer's guidelines, were also stable for at least 24 h and 8 h at 1 mg/mL and 3 mg/mL, respectively. All tested solutions were found physically stable up to 24 h at room temperature. The stability of dexrazoxane infusion solutions reported herein permits advance preparation of dexrazoxane intravenous admixtures, facilitating pharmacy workflow and clinical operations. However, due to the potential risks of fluid overload when these intravenous solutions are administered to patients, caution is advised to ensure patient safety.

Biomechanical Comparison of an Intramedullary and Extramedullary Free-Tissue Graft Reconstruction of the Acromioclavicular Joint Complex

PubMed Central

Garg, Rishi; Javidan, Pooya; Lee, Thay Q.

2013-01-01

Background Several different surgical techniques have been described to address the coracoclavicular (CC) ligaments in acromioclavicular (AC) joint injuries. However, very few techniques focus on reconstructing the AC ligaments, despite its importance in providing stability. The purpose of our study was to compare the biomechanical properties of two free-tissue graft techniques that reconstruct both the AC and CC ligaments in cadaveric shoulders, one with an extramedullary AC reconstruction and the other with an intramedullary AC reconstruction. We hypothesized intramedullary AC reconstruction will provide greater anteroposterior translational stability and improved load to failure characteristics than an extramedullary technique. Methods Six matched cadaveric shoulders underwent translational testing at 10 N and 15 N in the anteroposterior and superoinferior directions, under AC joint compression loads of 10 N, 20 N, and 30 N. After the AC and CC ligaments were transected, one of the specimens was randomly assigned the intramedullary free-tissue graft reconstruction while its matched pair received the extramedullary graft reconstruction. Both reconstructed specimens then underwent repeat translational testing, followed by load to failure testing, via superior clavicle distraction, at a rate of 50 mm/min. Results Intramedullary reconstruction provided significantly greater translational stability in the anteroposterior direction than the extramedullary technique for four of six loading conditions (p < 0.05). There were no significant differences in translational stability in the superoinferior direction for any loading condition. The intramedullary reconstructed specimens demonstrated improved load to failure characteristics with the intramedullary reconstruction having a lower deformation at yield and a higher ultimate load than the extramedullary reconstruction (p < 0.05). Conclusions Intramedullary reconstruction of the AC joint provides greater stability in the anteroposterior direction and improved load to failure characteristics than an extramedullary technique. Reconstruction of the injured AC joint with an intramedullary free tissue graft may provide greater strength and stability than other currently used techniques, allowing patients to have improved clinical outcomes. PMID:24340150

Primary stability of a cementless acetabular cup in a cohort of patient-specific finite element models.

PubMed

O'Rourke, Dermot; Al-Dirini, Rami Ma; Taylor, Mark

2018-03-01

The primary stability achieved during total hip arthroplasty determines the long-term success of cementless acetabular cups. Pre-clinical finite element testing of cups typically use a model of a single patient and assume the results can be extrapolated to the general population. This study explored the variability in predicted primary stability of a Pinnacle ® cementless acetabular cup in 103 patient-specific finite element models of the hemipelvis and examined the association between patient-related factors and the observed variability. Cups were inserted by displacement-control into the FE models and then a loading configuration simulating a complete level gait cycle was applied. The cohort showed a range of polar gap of 284-1112 μm and 95th percentile composite peak micromotion (CPM) of 18-624 μm. Regression analysis was not conclusive on the relationship between patient-related factors and primary stability. No relationship was found between polar gap and micromotion. However, when the patient-related factors were categorised into quartile groups, trends suggested higher polar gaps occurred in subjects with small and shallow acetabular geometries and cup motion during gait was affected most by low elastic modulus and high bodyweight. The variation in primary stability in the cohort for an acetabular cup with a proven clinical track record may provide benchmark data when evaluating new cup designs. © 2017 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 36:1012-1023, 2018. © 2017 Orthopaedic Research Society. Published by Wiley Periodicals, Inc.

Benefits of Spine Stabilization with Biodegradable Scaffolds in Spinal Cord Injured Rats

PubMed Central

Silva, Nuno A.; Sousa, Rui A.; Fraga, Joana S.; Fontes, Marco; Leite-Almeida, Hugo; Cerqueira, Rui; Almeida, Armando; Sousa, Nuno; Reis, Rui L.

2013-01-01

Spine stabilization upon spinal cord injury (SCI) is a standard procedure in clinical practice, but rarely employed in experimental models. Moreover, the application of biodegradable biomaterials for this would come as an advantage as it would eliminate the presence of a nondegradable prosthesis within the vertebral bone. Therefore, in the present work, we propose the use of a new biodegradable device specifically developed for spine stabilization in a rat model of SCI. A 3D scaffold based on a blend of starch with polycaprolactone was implanted, replacing delaminated vertebra, in male Wistar rats with a T8-T9 spinal hemisection. The impact of spinal stabilization on the locomotor behavior was then evaluated for a period of 12 weeks. Locomotor evaluation—assessed by Basso, Beatie, and Bresnahan test; rotarod; and open field analysis—revealed that injured rats subjected to spine stabilization significantly improved their motor performance, including higher coordination and rearing activity when compared with SCI rats without stabilization. Histological analysis further revealed that the presence of the scaffolds not only stabilized the area, but also simultaneously prevented the infiltration of the injury site by connective tissue. Overall, these results reveal that SCI stabilization using a biodegradable scaffold at the vertebral bone level leads to an improvement of the motor deficits and is a relevant element for the successful treatment of SCI. PMID:22779715

Home-based pulmonary rehabilitation in patients with chronic obstructive pulmonary disease: a randomized clinical trial

PubMed Central

Dias, Fernanda Dultra; Sampaio, Luciana Maria Malosá; da Silva, Graziela Alves; Gomes, Évelim LF Dantas; do Nascimento, Eloisa Sanches Pereira; Alves, Vera Lucia Santos; Stirbulov, Roberto; Costa, Dirceu

2013-01-01

Introduction Pulmonary rehabilitation (PR) is a multidisciplinary program of care for patients with chronic obstructive pulmonary disease (COPD) with the goal of improving the functional capacity and quality of life, as well as maintaining the clinical stability of COPD sufferers. However, not all patients are available for such a program despite discomfort with their condition. The aim of this study was to evaluate the effects of a home-based PR (HBPR) program on functional ability, quality of life, and respiratory muscle strength and endurance. Patients and methods Patients with COPD according to the Global Initiative of Chronic Obstructive Lung Disease were randomized (double-blind) into two groups. One group performed a protocol at home with aerobic and muscle strength exercises and was called the intervention group; the other group received only instructions to perform breathing and stretching exercises, characterizing it as the control group (CG). We assessed the following variables at baseline and 2 months: exercise tolerance (incremental shuttle walk test and upper limb test), respiratory muscle (strength and endurance test), and health-related quality of life (Airways Questionnaire 20). Results There were no significant changes after the intervention in either of the two groups in exercise tolerance and quality of life. However, the intervention group had improved respiratory endurance compared with the CG, while the CG presented a decrease in the load sustained by the respiratory muscles after the HBPR. Conclusion A program of HBPR with biweekly supervision (although not enough to provide significant improvements in physical capacity or quality of life) played an important role in maintaining the stability of the clinical features of patients with COPD; the patients had no worsening of symptoms during the intervention period according to the daily log. PMID:24235824

Intra-Aortic Balloon Counterpulsation in Patients with Chronic Heart Failure and Cardiogenic Shock: Clinical Response and Predictors of Stabilization

PubMed Central

Sintek, Marc A.; Gdowski, Mark; Lindman, Brian R.; Nassif, Michael; Lavine, Kory J.; Novak, Eric; Bach, Richard G.; Silvestry, Scott C.; Mann, Douglas L.; Joseph, Susan M.

2015-01-01

Objective To characterize the clinical response and identify predictors of clinical stabilization after intra-aortic balloon counterpulsation (IABP) support in patients with chronic systolic heart failure in cardiogenic shock prior to implantation of a left ventricular assist device (LVAD). Background Limited data exist regarding the clinical response to IABP in patients with chronic heart failure in cardiogenic shock. Methods We identified 54 patients supported with IABP prior to LVAD implantation. Criteria for clinical decompensation after IABP insertion and before LVAD included the need for more advanced temporary support, initiation of mechanical ventilation or dialysis, increase in vasopressors/inotropes, refractory ventricular arrhythmias, or worsening acidosis. The absence of these indicated stabilization. Results Clinical decompensation after IABP occurred in 23 (43%) patients. Both patients who decompensated and those who stabilized had similar hemodynamic improvements after IABP support but patients who decompensated required more vasopressors/inotropes. Clinical decompensation after IABP was associated with worse outcomes after LVAD implantation, including a 3-fold longer intensive care unit stay and 5-fold longer time on mechanical ventilation (p<0.01 for both). While baseline characteristics were similar between groups, right and left ventricular cardiac power indices (Cardiac power Index= Cardiac Index × Mean arterial pressure / 451)identified patients who were likely to stabilize (AUC=0.82). Conclusions Among patients with chronic systolic heart failure who develop cardiogenic shock, more than half of patients stabilized with IABP support as a bridge to LVAD. Baseline measures of right and left ventricular cardiac power, both measures of work performed for a given flow and pressure, may allow clinicians to identify patients with sufficient contractile reserve who will be likely to stabilize with an IABP versus those who may need more aggressive ventricular support. PMID:26164215

46 CFR 178.215 - Weight of passengers and crew.

Code of Federal Regulations, 2012 CFR

2012-10-01

..., for which stability information is based on the results of a simplified stability proof test. (b... simplified stability proof test and the number of passengers and crew included in the total test weight... TONS) INTACT STABILITY AND SEAWORTHINESS Stability Instructions for Operating Personnel § 178.215...

46 CFR 178.215 - Weight of passengers and crew.

Code of Federal Regulations, 2014 CFR

2014-10-01

..., for which stability information is based on the results of a simplified stability proof test. (b... simplified stability proof test and the number of passengers and crew included in the total test weight... TONS) INTACT STABILITY AND SEAWORTHINESS Stability Instructions for Operating Personnel § 178.215...

46 CFR 178.215 - Weight of passengers and crew.

Code of Federal Regulations, 2011 CFR

2011-10-01

..., for which stability information is based on the results of a simplified stability proof test. (b... simplified stability proof test and the number of passengers and crew included in the total test weight... TONS) INTACT STABILITY AND SEAWORTHINESS Stability Instructions for Operating Personnel § 178.215...

46 CFR 178.215 - Weight of passengers and crew.

Code of Federal Regulations, 2013 CFR

2013-10-01

..., for which stability information is based on the results of a simplified stability proof test. (b... simplified stability proof test and the number of passengers and crew included in the total test weight... TONS) INTACT STABILITY AND SEAWORTHINESS Stability Instructions for Operating Personnel § 178.215...

Accuracy verification and identification of matrix effects. The College of American Pathologists' Protocol.

PubMed

Eckfeldt, J H; Copeland, K R

1993-04-01

Proficiency testing using stabilized control materials has been used for decades as a means of monitoring and improving performance in the clinical laboratory. Often, the commonly used proficiency testing materials exhibit "matrix effects" that cause them to behave differently from fresh human specimens in certain clinical analytic systems. Because proficiency testing is the primary method in which regulatory agencies have chosen to evaluate clinical laboratory performance, the College of American Pathologists (CAP) has proposed guidelines for investigating the influence of matrix effects on their Survey results. The purpose of this investigation was to determine the feasibility, usefulness, and potential problems associated with this CAP Matrix Effect Analytical Protocol, in which fresh patient specimens and CAP proficiency specimens are analyzed simultaneously by a field method and a definitive, reference, or other comparative method. The optimal outcome would be that both the fresh human and CAP Survey specimens agree closely with the comparative method result. However, this was not always the case. Using several different analytic configurations, we were able to demonstrate matrix and calibration biases for several of the analytes investigated.

Influence of finishing/polishing on color stability and surface roughness of composites submitted to accelerated artificial aging.

PubMed

Pinto, Gustavo Da Col dos Santos; Dias, Kleber Campioni; Cruvinel, Diogo Rodrigues; Garcia, Lucas da Fonseca Roberti; Consani, Simonides; Pires-De-Souza, Fernanda de Carvalho Panzeri

2013-01-01

To assess the influence of finishing/polishing procedure on color stability (ΔE ) and surface roughness (R(a)) of composites (Heliomolar and Tetric - color A2) submitted to accelerated artificial aging (AAA). Sixty test specimens were made of each composite (12 mm × 2 mm) and separated into six groups (n = 10), according to the type of finishing/polishing to which they were submitted: C, control; F, tip 3195 F; FF, tip 3195 FF; FP, tip 3195 F + diamond paste; FFP, tip 3195 FF + diamond paste; SF, Sof-Lex discs. After polishing, controlled by an electromechanical system, initial color (spectrophotometer PCB 6807 BYK GARDNER) and R(a) (roughness meter Surfcorder SE 1700, cut-off 0.25 mm) readings were taken. Next, the test specimens were submitted to the AAA procedure (C-UV Comexim) for 384 hours, and at the end of this period, new color readings and R(a) were taken. Statistical analysis [2-way analysis of variance (ANOVA), Bonferroni, P < 0.05] showed that all composites demonstrated ΔE alteration above the clinically acceptable limits, with the exception of Heliomolar composite in FP. The greatest ΔE alteration occurred for Tetric composite in SF (13.38 ± 2.10) statistically different from F and FF (P < 0.05). For R(a), Group F showed rougher samples than FF with statistically significant difference (P < 0.05). In spite of the surface differences, the different finishing/polishing procedures were not capable of providing color stability within the clinically acceptable limits.

Add-on clinical effects of selective antagonist of 5HT6 receptors AVN-211 (CD-008-0173) in patients with schizophrenia stabilized on antipsychotic treatment: pilot study.

PubMed

Morozova, Margarita A; Lepilkina, Taisiya A; Rupchev, Georgy E; Beniashvily, Allan G; Burminskiy, Denis S; Potanin, Sergey S; Bondarenko, Evgeny V; Kazey, Vasily I; Lavrovsky, Yan; Ivachtchenko, Alexandre V

2014-08-01

The serotoninergic system as a target for add-on treatment seems to be a promising approach in patients with schizophrenia. To clarify if selective 5HT-6 antagonist AVN-211 (CD-008-0173) adds clinical and cognitive effects to stable antipsychotic treatment. A randomized, double-blind, placebo-controlled, add-on, 4r-week trial in 47 schizophrenia patients (21 patients receiving study drug and 26 receiving placebo) who were stabilized on antipsychotic medication was performed. Seventeen patients from the study drug group and 25 patients from the placebo group completed the trial. Treatment effects were measured using clinical rating scales and attention tests. With no differences at baseline, there was a significant difference between the groups in Positive and Negative Syndrome Scale (PANSS) positive subscale score (p = 0.058) in favor of patients in the treatment group at the endpoint. The PANSS positive subscore (p = 0.0068) and Clinical Global Impression-Severity (CGI-S) (p = 0.048) score significantly changed only in the treatment group. Only in the placebo group were significant changes in Calgary Depression Rating Scale (CDRS) total score registered. The indices of attention tests at endpoint did not show differences between the groups, with the exception of the scope of change in the results of the subtest VIII of the Wechsler Adult Intelligence Scale (WAIS), which showed difference between the groups (p = 0.02) and was significantly larger in the treatment group. Only inside the study drug group, significant changes in selectivity and continuous attention were observed regarding total correct responses (p = 0.0038) and reaction time (p = 0.058) in the Continuous Attention Task (CAT) test. Selective 5HT6 antagonist AVN-211 (CD-008-0173) added antipsychotic and some procognitive (attention) effects to antipsychotic medication.

The Pharmacogenomics of Bipolar Disorder study (PGBD): identification of genes for lithium response in a prospective sample.

PubMed

Oedegaard, Ketil J; Alda, Martin; Anand, Anit; Andreassen, Ole A; Balaraman, Yokesh; Berrettini, Wade H; Bhattacharjee, Abesh; Brennand, Kristen J; Burdick, Katherine E; Calabrese, Joseph R; Calkin, Cynthia V; Claasen, Ana; Coryell, William H; Craig, David; DeModena, Anna; Frye, Mark; Gage, Fred H; Gao, Keming; Garnham, Julie; Gershon, Elliot; Jakobsen, Petter; Leckband, Susan G; McCarthy, Michael J; McInnis, Melvin G; Maihofer, Adam X; Mertens, Jerome; Morken, Gunnar; Nievergelt, Caroline M; Nurnberger, John; Pham, Son; Schoeyen, Helle; Shekhtman, Tatyana; Shilling, Paul D; Szelinger, Szabolcs; Tarwater, Bruce; Yao, Jun; Zandi, Peter P; Kelsoe, John R

2016-05-05

Bipolar disorder is a serious and common psychiatric disorder characterized by manic and depressive mood switches and a relapsing and remitting course. The cornerstone of clinical management is stabilization and prophylaxis using mood-stabilizing medications to reduce both manic and depressive symptoms. Lithium remains the gold standard of treatment with the strongest data for both efficacy and suicide prevention. However, many patients do not respond to this medication, and clinically there is a great need for tools to aid the clinician in selecting the correct treatment. Large genome wide association studies (GWAS) investigating retrospectively the effect of lithium response are in the pipeline; however, few large prospective studies on genetic predictors to of lithium response have yet been conducted. The purpose of this project is to identify genes that are associated with lithium response in a large prospective cohort of bipolar patients and to better understand the mechanism of action of lithium and the variation in the genome that influences clinical response. This study is an 11-site prospective non-randomized open trial of lithium designed to ascertain a cohort of 700 subjects with bipolar I disorder who experience protocol-defined relapse prevention as a result of treatment with lithium monotherapy. All patients will be diagnosed using the Diagnostic Interview for Genetic Studies (DIGS) and will then enter a 2-year follow-up period on lithium monotherapy if and when they exhibit a score of 1 (normal, not ill), 2 (minimally ill) or 3 (mildly ill) on the Clinical Global Impressions of Severity Scale for Bipolar Disorder (CGI-S-BP Overall Bipolar Illness) for 4 of the 5 preceding weeks. Lithium will be titrated as clinically appropriate, not to exceed serum levels of 1.2 mEq/L. The sample will be evaluated longitudinally using a wide range of clinical scales, cognitive assessments and laboratory tests. On relapse, patients will be discontinued or crossed-over to treatment with valproic acid (VPA) or treatment as usual (TAU). Relapse is defined as a DSM-IV manic, major depressive or mixed episode or if the treating physician decides a change in medication is clinically necessary. The sample will be genotyped for GWAS. The outcome for lithium response will be analyzed as a time to event, where the event is defined as clinical relapse, using a Cox Proportional Hazards model. Positive single nucleotide polymorphisms (SNPs) from past genetic retrospective studies of lithium response, the Consortium on Lithium Genetics (ConLiGen), will be tested in this prospective study sample; a meta-analysis of these samples will then be performed. Finally, neurons will be derived from pluripotent stem cells from lithium responders and non-responders and tested in vivo for response to lithium by gene expression studies. SNPs in genes identified in these cellular studies will also be tested for association to response. Lithium is an extraordinarily important therapeutic drug in the clinical management of patients suffering from bipolar disorder. However, a significant proportion of patients, 30-40 %, fail to respond, and there is currently no method to identify the good lithium responders before initiation of treatment. Converging evidence suggests that genetic factors play a strong role in the variation of response to lithium, but only a few genes have been tested and the samples have largely been retrospective or quite small. The current study will collect an entirely unique sample of 700 patients with bipolar disorder to be stabilized on lithium monotherapy and followed for up to 2 years. This study will produce useful information to improve the understanding of the mechanism of action of lithium and will add to the development of a method to predict individual response to lithium, thereby accelerating recovery and reducing suffering and cost. ClinicalTrials.gov Identifier: NCT01272531 Registered: January 6, 2011.

Conventional Rapid Latex Agglutination in Estimation of von Willebrand Factor: Method Revisited and Potential Clinical Applications

PubMed Central

Che Hussin, Che Maraina

2014-01-01

Measurement of von Willebrand factor antigen (VWF : Ag) levels is usually performed in a specialised laboratory which limits its application in routine clinical practice. So far, no commercial rapid test kit is available for VWF : Ag estimation. This paper discusses the technical aspect of latex agglutination method which was established to suit the purpose of estimating von Willebrand factor (VWF) levels in the plasma sample. The latex agglutination test can be performed qualitatively and semiquantitatively. Reproducibility, stability, linearity, limit of detection, interference, and method comparison studies were conducted to evaluate the performance of this test. Semiquantitative latex agglutination test was strongly correlated with the reference immunoturbidimetric assay (Spearman's rho = 0.946, P < 0.001, n = 132). A substantial agreement (κ = 0.77) was found between qualitative latex agglutination test and the reference assay. Using the scoring system for the rapid latex test, no agglutination is with 0% VWF : Ag (control negative), 1+ reaction is equivalent to <20% VWF : Ag, and 4+ reaction indicates >150% VWF : Ag (when comparing with immunoturbidimetric assay). The findings from evaluation studies suggest that latex agglutination method is suitable to be used as a rapid test kit for the estimation of VWF : Ag levels in various clinical conditions associated with high levels and low levels of VWF : Ag. PMID:25759835

Double-bundle ACL reconstruction can improve rotational stability.

PubMed

Yagi, Masayoshi; Kuroda, Ryosuke; Nagamune, Kouki; Yoshiya, Shinichi; Kurosaka, Masahiro

2007-01-01

Double-bundle anterior cruciate ligament (ACL) reconstruction reproduces anteromedial and posterolateral bundles, and thus has theoretical advantages over conventional single-bundle reconstruction in controlling rotational torque in vitro. However, its superiority in clinical practice has not been proven. We analyzed rotational stability with three reconstruction techniques in 60 consecutive patients who were randomly divided into three groups (double-bundle, anteromedial single-bundle, posterolateral single-bundle). In the reconstructive procedure, the hamstring tendon was harvested and used as a free tendon graft. Followup examinations were performed 1 year after surgery. Anteroposterior laxity of the knee was examined with a KT-1000 arthrometer, whereas rotatory instability, as elicited by the pivot shift test, was assessed using a new measurement system incorporating three-dimensional electromagnetic sensors. Routine clinical evaluations, including KT examination, demonstrated no differences among the three groups. However, using the new measurement system, patients with double-bundle ACL reconstruction showed better pivot shift control of complex instability than patients with anteromedial and posterolateral single-bundle reconstruction.

Comparison of mechanical and biological properties of zirconia and titanium alloy orthodontic micro-implants.

PubMed

Choi, Hae Won; Park, Young Seok; Chung, Shin Hye; Jung, Min Ho; Moon, Won; Rhee, Sang Hoon

2017-07-01

The aim of this study was to compare the initial stability as insertion and removal torque and the clinical applicability of novel orthodontic zirconia micro-implants made using a powder injection molding (PIM) technique with those parameters in conventional titanium micro-implants. Sixty zirconia and 60 titanium micro-implants of similar design (diameter, 1.6 mm; length, 8.0 mm) were inserted perpendicularly in solid polyurethane foam with varying densities of 20 pounds per cubic foot (pcf), 30 pcf, and 40 pcf. Primary stability was measured as maximum insertion torque (MIT) and maximum removal torque (MRT). To investigate clinical applicability, compressive and tensile forces were recorded at 0.01, 0.02, and 0.03 mm displacement of the implants at angles of 0°, 10°, 20°, 30°, and 40°. The biocompatibility of zirconia micro-implants was assessed via an experimental animal study. There were no statistically significant differences between zirconia micro-implants and titanium alloy implants with regard to MIT, MRT, or the amount of movement in the angulated lateral displacement test. As angulation increased, the mean compressive and tensile forces required to displace both types of micro-implants increased substantially at all distances. The average bone-to-implant contact ratio of prototype zirconia micro-implants was 56.88 ± 6.72%. Zirconia micro-implants showed initial stability and clinical applicability for diverse orthodontic treatments comparable to that of titanium micro-implants under compressive and tensile forces.

Effects of 12-week proprioception training program on postural stability, gait, and balance in older adults: a controlled clinical trial.

PubMed

Martínez-Amat, Antonio; Hita-Contreras, Fidel; Lomas-Vega, Rafael; Caballero-Martínez, Isabel; Alvarez, Pablo J; Martínez-López, Emilio

2013-08-01

The purpose of this study was to evaluate the effect of a 12-week-specific proprioceptive training program on postural stability, gait, balance, and fall prevention in adults older than 65 years. The present study was a controlled clinical trial. Forty-four community dwelling elderly subjects (61-90 years; mean age, 78.07 ± 5.7 years) divided into experimental (n = 20) and control (n = 24) groups. The participants performed the Berg balance test before and after the training program, and we assessed participants' gait, balance, and the risk of falling, using the Tinetti scale. Medial-lateral plane and anterior-posterior plane displacements of the center of pressure, Sway area, length and speed, and the Romberg quotient about surface, speed, and distance were calculated in static posturography analysis (EPS pressure platform) under 2 conditions: eyes open and eyes closed. After a first clinical evaluation, patients were submitted to 12 weeks proprioception training program, 2 sessions of 50 minutes every week. This program includes 6 exercises with the BOSU and Swiss ball as unstable training tools that were designed to program proprioceptive training. The training program improved postural balance of older adults in mediolateral plane with eyes open (p < 0.05) and anterior-posterior plane with eyes closed (p < 0.01). Significant improvements were observed in Romberg quotient about surface (p < 0.05) and speed (p < 0.01) but not about distance (p > 0.05). After proprioception training, gait (Tinetti), and balance (Berg) test scores improved 14.66% and 11.47% respectively. These results show that 12 weeks proprioception training program in older adults is effective in postural stability, static, and dynamic balance and could lead to an improvement in gait and balance capacity, and to a decrease in the risk of falling in adults aged 65 years and older.

Advances in neglected tropical disease vaccines: Developing relative potency and functional assays for the Na-GST-1/Alhydrogel hookworm vaccine.

PubMed

Brelsford, Jill B; Plieskatt, Jordan L; Yakovleva, Anna; Jariwala, Amar; Keegan, Brian P; Peng, Jin; Xia, Pengjun; Li, Guangzhao; Campbell, Doreen; Periago, Maria Victoria; Correa-Oliveira, Rodrigo; Bottazzi, Maria Elena; Hotez, Peter J; Diemert, David; Bethony, Jeffrey M

2017-02-01

A new generation of vaccines for the neglected tropical diseases (NTDs) have now advanced into clinical development, with the Na-GST-1/Alhydrogel Hookworm Vaccine already being tested in Phase 1 studies in healthy adults. The current manuscript focuses on the often overlooked critical aspects of NTD vaccine product development, more specifically, vaccine stability testing programs. A key measure of vaccine stability testing is "relative potency" or the immunogenicity of the vaccine during storage. As with most NTD vaccines, the Na-GST-1/Alhydrogel Hookworm Vaccine was not developed by attenuation or inactivation of the pathogen (Necator americanus), so conventional methods for measuring relative potency are not relevant for this investigational product. Herein, we describe a novel relative potency testing program and report for the first time on the clinical lot of this NTD vaccine during its first 60 months of storage at 2-8°C. We also describe the development of a complementary functional assay that measures the ability of IgG from animals or humans immunized with Na-GST-1/Alhydrogel to neutralize this important hookworm enzyme. While 90% inhibition of the catalytic activity of Na-GST-1 was achieved in animals immunized with Na-GST-1/Alhydrogel, lower levels of inhibition were observed in immunized humans. Moreover, anti-Na-GST-1 antibodies from volunteers in non-hookworm endemic areas were better able to inhibit catalytic activity than anti-Na-GST-1 antibodies from volunteers resident in hookworm endemic areas. The results described herein provide the critical tools for the product development of NTD vaccines.

Circulating Tumor DNA Analysis in Patients With Cancer: American Society of Clinical Oncology and College of American Pathologists Joint Review.

PubMed

Merker, Jason D; Oxnard, Geoffrey R; Compton, Carolyn; Diehn, Maximilian; Hurley, Patricia; Lazar, Alexander J; Lindeman, Neal; Lockwood, Christina M; Rai, Alex J; Schilsky, Richard L; Tsimberidou, Apostolia M; Vasalos, Patricia; Billman, Brooke L; Oliver, Thomas K; Bruinooge, Suanna S; Hayes, Daniel F; Turner, Nicholas C

2018-06-01

Purpose Clinical use of analytical tests to assess genomic variants in circulating tumor DNA (ctDNA) is increasing. This joint review from ASCO and the College of American Pathologists summarizes current information about clinical ctDNA assays and provides a framework for future research. Methods An Expert Panel conducted a literature review on the use of ctDNA assays for solid tumors, including pre-analytical variables, analytical validity, interpretation and reporting, and clinical validity and utility. Results The literature search identified 1,338 references. Of those, 390, plus 31 references supplied by the Expert Panel, were selected for full-text review. There were 77 articles selected for inclusion. Conclusion The evidence indicates that testing for ctDNA is optimally performed on plasma collected in cell stabilization or EDTA tubes, with EDTA tubes processed within 6 hours of collection. Some ctDNA assays have demonstrated clinical validity and utility with certain types of advanced cancer; however, there is insufficient evidence of clinical validity and utility for the majority of ctDNA assays in advanced cancer. Evidence shows discordance between the results of ctDNA assays and genotyping tumor specimens and supports tumor tissue genotyping to confirm undetected results from ctDNA tests. There is no evidence of clinical utility and little evidence of clinical validity of ctDNA assays in early-stage cancer, treatment monitoring, or residual disease detection. There is no evidence of clinical validity and clinical utility to suggest that ctDNA assays are useful for cancer screening, outside of a clinical trial. Given the rapid pace of research, re-evaluation of the literature will shortly be required, along with the development of tools and guidance for clinical practice.

Sensory-Challenge Balance Exercises Improve Multisensory Reweighting in Fall-Prone Older Adults.

PubMed

Allison, Leslie K; Kiemel, Tim; Jeka, John J

2018-04-01

Multisensory reweighting (MSR) deficits in older adults contribute to fall risk. Sensory-challenge balance exercises may have value for addressing the MSR deficits in fall-prone older adults. The purpose of this study was to examine the effect of sensory-challenge balance exercises on MSR and clinical balance measures in fall-prone older adults. We used a quasi-experimental, repeated-measures, within-subjects design. Older adults with a history of falls underwent an 8-week baseline (control) period. This was followed by an 8-week intervention period that included 16 sensory-challenge balance exercise sessions performed with computerized balance training equipment. Measurements, taken twice before and once after intervention, included laboratory measures of MSR (center of mass gain and phase, position, and velocity variability) and clinical tests (Activities-specific Balance Confidence Scale, Berg Balance Scale, Sensory Organization Test, Limits of Stability test, and lower extremity strength and range of motion). Twenty adults 70 years of age and older with a history of falls completed all 16 sessions. Significant improvements were observed in laboratory-based MSR measures of touch gain (P = 0.006) and phase (P = 0.05), Berg Balance Scale (P = 0.002), Sensory Organization Test (P = 0.002), Limits of Stability Test (P = 0.001), and lower extremity strength scores (P = 0.005). Mean values of vision gain increased more than those for touch gain, but did not reach significance. A balance exercise program specifically targeting multisensory integration mechanisms improved MSR, balance, and lower extremity strength in this mechanistic study. These valuable findings provide the scientific rationale for sensory-challenge balance exercise to improve perception of body position and motion in space and potential reduction in fall risk.

Testing the Hip Abductor Muscle Strength of Older Persons Using a Handheld Dynamometer.

PubMed

Awwad, Daniel H; Buckley, Jonathan D; Thomson, Rebecca L; O'Connor, Matthew; Carbone, Tania A; Chehade, Mellick J

2017-09-01

To investigate the reliability of a clinically applicable method of dynamometry to assess and monitor hip abductor muscle strength in older persons. Bilateral isometric hip abductor muscle strength measured with a handheld dynamometer, patients supine with the contralateral hip positioned directly against a wall for stabilization. Reliability determined by comparing intra-assessor and inter-assessor results and comparison to a criterion standard (stabilized dynamometer with patients in the standing position). UniSA Nutritional Physiology Research Centre. Twenty-one patients older than 65 years were recruited from the Royal Adelaide Hospital. Intraclass correlation coefficients (ICCs), bias, and limits of agreement calculated to determine reliability. Intra-assessor and inter-assessor ICCs were high (0.94 and 0.92-0.94, respectively). There was no intra-assessor bias and narrow limits of agreement (±2.4%). There was a small inter-assessor bias but narrow limits of agreement (0.6%-0.9% and ± 2.3%, respectively). There was a wide variation comparing results to the criterion standard (±5.0%-5.2% limits of agreement), highlighting problems attributed to difficulties that the test population had with the standing position used in the criterion standard test. Testing older persons' hip abductor muscle strength while in the supine position with optimal pelvic stabilization using a handheld dynamometer is highly reliable. While further studies must be done to assess patients with specific pathologies, this test has potential application to monitor and evaluate the effects of surgical interventions and/or rehabilitation protocols for a variety of conditions affecting hip abductor function such as hip fractures and arthritis.

Anatomy and physical examination of the knee menisci: a narrative review of the orthopedic literature.

PubMed

Chivers, Michael D; Howitt, Scott D

2009-12-01

The objective of this study was to review the physical examination tests available to a practitioner in order to arrive at a clinical diagnosis or suspicion of a meniscal lesion. The menisci transmit weight bearing forces and increase stability of the knee. The menisci also facilitate nutrition, provide lubrication and shock absorption for the articular cartilage and promote knee proprioception. The combinations of torsional and axial loading appear to be the cause of most meniscal injuries. Diagnosis of acute knee injuries has long been a topic for discussion throughout the orthopedic literature. Many clinical tests and diagnostic studies have been developed to increase the clinician's ability to accurately diagnose these types of disorders of the knee. The accuracy of all diagnostic tests is thought to be dependant upon the skill of the examiner, and the severity and location of the injury. The multitude of tests described to assess meniscal lesions suggests that none are consistently reliable. However, recent research has focused on a composite score to accurately predict meniscus lesions. The combination of a comprehensive history, multiple physical tests and diagnostic imaging for confirmation is typical for a clinical meniscal lesion diagnosis while the gold standard remains the arthroscopic procedure itself.

Analytical validation of a novel multiplex test for detection of advanced adenoma and colorectal cancer in symptomatic patients.

PubMed

Dillon, Roslyn; Croner, Lisa J; Bucci, John; Kairs, Stefanie N; You, Jia; Beasley, Sharon; Blimline, Mark; Carino, Rochele B; Chan, Vicky C; Cuevas, Danissa; Diggs, Jeff; Jennings, Megan; Levy, Jacob; Mina, Ginger; Yee, Alvin; Wilcox, Bruce

2018-05-30

Early detection of colorectal cancer (CRC) is key to reducing associated mortality. Despite the importance of early detection, approximately 40% of individuals in the United States between the ages of 50-75 have never been screened for CRC. The low compliance with colonoscopy and fecal-based screening may be addressed with a non-invasive alternative such as a blood-based test. We describe here the analytical validation of a multiplexed blood-based assay that measures the plasma concentrations of 15 proteins to assess advanced adenoma (AA) and CRC risk in symptomatic patients. The test was developed on an electrochemiluminescent immunoassay platform employing four multi-marker panels, to be implemented in the clinic as a laboratory developed test (LDT). Under the Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP) regulations, a United States-based clinical laboratory utilizing an LDT must establish performance characteristics relating to analytical validity prior to releasing patient test results. This report describes a series of studies demonstrating the precision, accuracy, analytical sensitivity, and analytical specificity for each of the 15 assays, as required by CLIA/CAP. In addition, the report describes studies characterizing each of the assays' dynamic range, parallelism, tolerance to common interfering substances, spike recovery, and stability to sample freeze-thaw cycles. Upon completion of the analytical characterization, a clinical accuracy study was performed to evaluate concordance of AA and CRC classifier model calls using the analytical method intended for use in the clinic. Of 434 symptomatic patient samples tested, the percent agreement with original CRC and AA calls was 87% and 92% respectively. All studies followed CLSI guidelines and met the regulatory requirements for implementation of a new LDT. The results provide the analytical evidence to support the implementation of the novel multi-marker test as a clinical test for evaluating CRC and AA risk in symptomatic individuals. Copyright © 2018 Elsevier B.V. All rights reserved.

Positive and negative affect dimensions in chronic knee osteoarthritis: effects on clinical and laboratory pain.

PubMed

Finan, Patrick H; Quartana, Phillip J; Smith, Michael T

2013-06-01

This study investigated whether daily and laboratory assessed pain differs as a function of the temporal stability and valence of affect in individuals with chronic knee osteoarthritis (KOA). One hundred fifty-one men and women with KOA completed 14 days of electronic diaries assessing positive affect (PA), negative affect (NA), and clinical pain. A subset of participants (n =79) engaged in quantitative sensory testing (QST). State PA and NA were assessed prior to administration of stimuli that induced suprathreshold pain and temporal summation. Multilevel modeling and multiple regression evaluated associations of affect and pain as a function of valence (i.e., positive versus negative) and stability (i.e., stable versus state). In the diary, stable NA (B = -.63, standard error [SE] = .13, p < .001) was a stronger predictor of clinical KOA pain than stable PA (B = -.18, SE = .11, p = .091), and state PA (B = -.09, p < .001) was a stronger predictor of concurrent daily clinical pain than state NA (B = .04, SE = .02, p = .068). In the laboratory, state PA (B = -.05, SE = .02, p = .042), but not state NA (p = .46), predicted diminished temporal summation of mechanical pain. Stable NA is more predictive of clinical pain than stable PA, whereas state PA is more predictive of both clinical and laboratory pain than state NA. The findings suggest that dynamic affect-pain processes in the field may reflect individual differences in central pain facilitation.

Comparing Postural Stability Entropy Analyses to Differentiate Fallers and Non-Fallers

PubMed Central

Fino, Peter C.; Mojdehi, Ahmad R.; Adjerid, Khaled; Habibi, Mohammad; Lockhart, Thurmon E.; Ross, Shane D.

2015-01-01

The health and financial cost of falls has spurred research to differentiate the characteristics of fallers and non-fallers. Postural stability has received much of the attention with recent studies exploring various measures of entropy. This study compared the discriminatory ability of several entropy methods at differentiating two paradigms in the center-of-pressure (COP) of elderly individuals: 1.) eyes open (EO) versus eyes closed (EC) and 2.) fallers (F) versus non-fallers (NF). Methods were compared using the area under the curve (AUC) of the receiver-operating characteristic (ROC) curves developed from logistic regression models. Overall, multiscale entropy (MSE) and composite multiscale entropy (CompMSE) performed the best with AUCs of 0.71 for EO/EC and 0.77 for F/NF. When methods were combined together to maximize the AUC, the entropy classifier had an AUC of for 0.91 the F/NF comparison. These results suggest researchers and clinicians attempting to create clinical tests to identify fallers should consider a combination of every entropy method when creating a classifying test. Additionally, MSE and CompMSE classifiers using polar coordinate data outperformed rectangular coordinate data, encouraging more research into the most appropriate time series for postural stability entropy analysis. PMID:26464267

Comparing Postural Stability Entropy Analyses to Differentiate Fallers and Non-fallers.

PubMed

Fino, Peter C; Mojdehi, Ahmad R; Adjerid, Khaled; Habibi, Mohammad; Lockhart, Thurmon E; Ross, Shane D

2016-05-01

The health and financial cost of falls has spurred research to differentiate the characteristics of fallers and non-fallers. Postural stability has received much of the attention with recent studies exploring various measures of entropy. This study compared the discriminatory ability of several entropy methods at differentiating two paradigms in the center-of-pressure of elderly individuals: (1) eyes open (EO) vs. eyes closed (EC) and (2) fallers (F) vs. non-fallers (NF). Methods were compared using the area under the curve (AUC) of the receiver-operating characteristic curves developed from logistic regression models. Overall, multiscale entropy (MSE) and composite multiscale entropy (CompMSE) performed the best with AUCs of 0.71 for EO/EC and 0.77 for F/NF. When methods were combined together to maximize the AUC, the entropy classifier had an AUC of for 0.91 the F/NF comparison. These results suggest researchers and clinicians attempting to create clinical tests to identify fallers should consider a combination of every entropy method when creating a classifying test. Additionally, MSE and CompMSE classifiers using polar coordinate data outperformed rectangular coordinate data, encouraging more research into the most appropriate time series for postural stability entropy analysis.

The influence of peripheral neuropathy, gender, and obesity on the postural stability of patients with type 2 diabetes mellitus.

PubMed

Herrera-Rangel, Aline; Aranda-Moreno, Catalina; Mantilla-Ochoa, Teresa; Zainos-Saucedo, Lylia; Jáuregui-Renaud, Kathrine

2014-01-01

To assess the influence of peripheral neuropathy, gender, and obesity on the postural stability of patients with type 2 diabetes mellitus. 151 patients with no history of otology, neurology, or orthopaedic or balance disorders accepted to participate in the study. After a clinical interview and neuropathy assessment, postural stability was evaluated by static posturography (eyes open/closed on hard/soft surface) and the "Up & Go" test. During static posturography, on hard surface, the length of sway was related to peripheral neuropathy, gender, age, and obesity; on soft surface, the length of sway was related to peripheral neuropathy, gender, and age, the influence of neuropathy was larger in males than in females, and closing the eyes increased further the difference between genders. The mean time to perform the "Up & Go" test was 11.6 ± 2.2 sec, with influence of peripheral neuropathy, gender, and age. In order to preserve the control of static upright posture during conditions with deficient sensory input, male patients with type 2 diabetes mellitus with no history of balance disorders may be more vulnerable than females, and obesity may decrease the static postural control in both males and females.

Field and laboratory studies on Corridor disease (Theileria parva infection) in cattle population at the livestock/game interface of uPhongolo-Mkuze area, South Africa.

PubMed

Mbizeni, Sikhumbuzo; Potgieter, Fred T; Troskie, Christo; Mans, Ben J; Penzhorn, Barend L; Latif, Abdalla A

2013-04-01

Corridor disease (Theileria parva infection in cattle associated with carrier buffaloes) had not been reported to cause serious outbreaks in South Africa prior to 1994. In recent years, there has been an increase in the introduction of T. parva-infected buffaloes onto private game parks in Northern KwaZulu-Natal (KZN). The objectives of this study were to investigate the number of T. parva outbreaks in cattle at the livestock/wildlife interface and to establish the possible T. parva carrier status in cattle which were diagnosed to have recovered from clinical disease. The occurrence of outbreaks was closely monitored from 2004 to 2009 covering a total of 15 localities. The observations included the number of cattle involved in the outbreaks, clinical signs, parasitological and post-mortem examinations, as well as serological and molecular tests specific for T. parva. Sentinel cattle were introduced to monitor tick transmission and some of these recovered from clinical T. parva infection in the field and confirmed to be positive by PCR, were challenged using lethal T. parva stabilates to ascertain their immune status. Thirty-one Corridor disease outbreaks were recorded during the study period. Of the 846 cattle tested for Corridor disease during the study period, 140 (16.5%) were found positive by the real time PCR and IFA tests. Eighty-two (9.7%) cattle were found positive by the IFA test only. The prevalence of T. parva infection was 26.2%. Adult R. appendiculatus fed as nymphs on 5 bovines which recovered from clinical T. parva infection in the field transmitted only T. taurotragi to susceptible bovines. However, 8 of the field-recovered cattle resisted lethal challenge using T. parva tick stabilate. Though the study could not demonstrate cattle-to-cattle transmission by ticks using 5 previously infected cattle in the field, it is suggested that Corridor disease should be considered a potential emerging disease, and more stringent control methods should be implemented. Copyright © 2013 Elsevier GmbH. All rights reserved.

[Structure and properties of colored dental tetragonal zirconia stabilized by yttrium ceramics].

PubMed

Yi, Yuan-fu; Wang, Chen; Wen, Ning; Lin, Yong-zhao; Tian, Jie-mo

2009-10-01

To investigate the structure, mechanical and low temperature aging properties of colored dental zirconia ceramics. 5 graded colored dental zirconia ceramics were made by adding colorants and their combinations into a 3Y-TZP (tetragonal zirconia stabilized by 3mol% yttrium) powder, the green body were compacted at 200 MPa, pre-sinter at 1,050 degrees C and maintained for 2 h, then densely sintered at 1,500 degrees C for 2 h. Specimens were cut from each of the 5 graded colored blocks. Physical, mechanical properties as well as chemical stability were tested, microstructure were observed, crystalline phase were identified by X-ray diffraction (XRD), aging properties were assessed by measurement of the relative content of monoclinic phase and bending strength testing. The overall density of colored zirconia ceramics was over 99.7%, linear shrinkage was about 20%, while thermal expansion coefficient was about 11 x 10(-6) x degrees C(-1), the crystalline phase was tetragonal, bending strength was over 900 MPa which was slightly lowered than that of the uncolored zirconia, fracture toughness was slightly higher. Good chemical stability in acetic acid was observed. After aging treatment, tetragonal-to-monoclinic phase transformation was detected up to 40%, while bending strength was not significantly degraded. The results showed that colored 3Y-TZP ceramics presented good mechanical properties even after aging treatments, and was suitable for dental clinical use.

Clinical and Molecular Consequences of NF1 Microdeletion

DTIC Science & Technology

2006-05-01

service based on meta -PCR/sequencing, dosage analysis , and loss of heterozygosity analysis . Genet Test 2004;8(4):368-80. 51. Kluwe L, Mautner VF. Mosaicism...neurofibromin in normal centrosome function and in maintaining genome stability. Our detailed analysis of human and chimpanzee genome sequences were...chromosomes and DNA fibers (1). Tandem duplication of the region would have significant impact on many aspects of NF1 research, e.g., mutational analysis

[Definition and stabilization of processes II. Clinical Processes in a Urology Department].

PubMed

Pascual, Carlos; Luján, Marcos; Mora, José Ramón; Diz, Manuel Ramón; Martín, Carlos; López, María Carmen

2015-01-01

New models in clinical management seek a clinical practice based on quality, efficacy and efficiency, avoiding variability and improvisation. In this paper we have developed one of the most frequent clinical processes in our speciality, the process based on DRG 311 or transurethral procedures without complications. Along it we will describe its components: Stabilization form, clinical trajectory, cost calculation, and finally the process flowchart.

Time since injury limits but does not prevent improvement and maintenance of gains in balance in chronic stroke.

PubMed

Llorens, Roberto; Noé, Enrique; Alcañiz, Mariano; Deutsch, Judith E

2018-01-01

To determine the influence of time since injury on the efficacy and maintenance of gains of rehabilitation of balance after stroke. Forty-seven participants were assigned to a least (6-12 months), a moderate (12-24 months), or a most chronic (>24 months) group. Participants trained for 20 one-hour sessions, administered three to five times a week, combining conventional physical therapy and visual feedback-based exercises that trained the ankle and hip strategies. Participants were assessed before, after the intervention, and one month later with a posturography test (Sway Speed and Limits of Stability) and clinical scales. In contrast to other subjects, the most chronic participants failed to improve their sway and to maintain the benefits detected in the Limits of Stability after the intervention. Although all the participants improved in those clinical tests that better matched the trained skills, time since injury limited the improvement, and over all, the maintenance of gains. Time since injury limits but does not prevent improvement in chronic stages post-stroke, and this effect appears to be more pronounced with maintaining gains. These findings support that training duration and intensity as well as type of therapy may need to be adjusted based on time post-stroke.

Influence of light and oxygen on the color stability of five calcium silicate-based materials.

PubMed

Vallés, Marta; Mercadé, Montse; Duran-Sindreu, Fernando; Bourdelande, Jose L; Roig, Miguel

2013-04-01

Difficult handling, long setting time, and potential discoloration are important drawbacks of white mineral trioxide aggregate (WMTA). The development of Biodentine, a recently developed calcium silicate-based material (CSM), has overcome some of these shortcomings; however, there are no available data on its color stability. A previous study showed that WMTA discolors under light irradiation in an oxygen-free environment. The present study evaluated the influence of light irradiation and oxygen on the color stability of 5 CSMs. Fifteen samples of 5 CSMs (ProRoot WMTA, Angelus WMTA, White Portland Cement [PC], PC with bismuth oxide, and Biodentine) were divided into 5 groups. Each group was exposed to different oxygen and light conditions. A spectrophotometer was used to determine the color of each specimen at 0, 120 seconds, and 5 days. Data were analyzed by using analysis of variance and Tukey honestly significant difference test. The materials PC with bismuth oxide, Angelus WMTA, and ProRoot WMTA showed dark discoloration after light irradiation in an oxygen-free environment, which was statistically significantly different from Biodentine and PC. In groups that were exposed to no light irradiation or to an oxygen atmosphere, all materials showed color stability over time, and no significant differences were observed among them. PC and Biodentine maintained color stability in all conditions over time and showed no significant differences. The combination of light and anaerobic conditions (similar to those in clinical situations) results in differences in color of the tested CSMs during a period of 5 days, of which Biodentine and PC demonstrated color stability. Copyright © 2013 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Use of External Quality Control Material for HIV-1 RNA Testing To Assess the Comparability of Data Generated in Separate Laboratories and the Stability of HIV-1 RNA in Samples after Prolonged Storage.

PubMed

Jennings, Cheryl; Wager, Carrie G; Scianna, Salvatore R; Zaccaro, Daniel J; Couzens, Amy; Mellors, John W; Coombs, Robert W; Bremer, James W

2018-06-01

The National Institute of Allergy and Infectious Diseases (NIAID) AIDS Clinical Trials Group (ACTG) stores specimens from its clinical trials in a biorepository and permits the use of these specimens for nonprotocol exploratory studies, once the studies for the original protocol are concluded. We sought to assess the comparability of the data generated from real-time HIV-1 RNA testing during two clinical trials with the data generated from the retesting of different aliquots of the same samples after years of storage at -80°C. Overall, there was 92% agreement in the data generated for 1,570 paired samples (kappa statistic = 0.757; 95% confidence interval [CI], 0.716 to 0.797), where samples were tested in one laboratory using the microwell plate (MWP) version of the Roche HIV-1 Monitor test within 1 to 37 days of collection and retested in another laboratory using the Cobas version of the assay after a median of 6.7 years of storage (range, 5.7 to 8.6 years). Historical external quality control data submitted to the NIAID Virology Quality Assurance program (VQA) by client laboratories using the same two versions of the Monitor assay were used to differentiate between systematic differences in the assays to evaluate the stability of HIV-1 RNA in the stored samples. No significant loss of RNA was noted in samples containing either a low concentration (<50 copies/ml) or a high concentration (≥50 copies/ml) of HIV-1 RNA ( P = 0.10 and P = 0.90, respectively) regardless of the time in storage. These data confirm the quality of the plasma samples in the ACTG biorepository following long-term storage. Copyright © 2018 American Society for Microbiology.

An in vitro characterization of cefditoren, a new oral cephalosporin.

PubMed

Felmingham, D; Robbins, M J; Ghosh, G; Bhogal, H; Mehta, M D; Leakey, A; Clark, S; Dencer, C A; Ridgway, G L; Grüneberg, R N

1994-01-01

Cefditoren (ME 1206) is a new cephalosporin available for oral administration as the pivaloyloxymethyl ester (ME 1207). The effect of medium formulation. pH, cation concentration and inoculum on the in vitro activity of cefditoren was investigated prior to determining its comparative antibacterial potency against a wide range of clinical bacterial isolates, its bactericidal activity against susceptible strains and the duration of its post-antibiotic effect (PAE). Cefditoren was shown to possess a broad-spectrum of cidal antibacterial activity against both Gram-positive and Gram-negative species with stability to many beta-lactamases of clinical importance. Its activity against Gram-positive species was similar to augmentin and cefuroxime, but superior to that of cefaclor and cefixime, while its beta-lactamase stability was similar to that of cefixime and ceftazidine, characterizing it as a third generation cephalosporin. Investigation of the effect of laboratory variables on the in vitro activity of cefditoren indicates that it will present no special problems when tested in the clinical setting against bacterial pathogens. PAE of 0.9 h, or greater, for Staphylococcus spp, Streptococcus pneumoniae and Moraxella catarrhalis may support the use of an extended dose-interval when cefditoren is used for the treatment of respiratory tract infections.

Post-analytical stability of 23 common chemistry and immunochemistry analytes in incurred samples.

PubMed

Nielsen, Betina Klint; Frederiksen, Tina; Friis-Hansen, Lennart; Larsen, Pia Bükmann

2017-12-01

Storage of blood samples after centrifugation, decapping and initial sampling allows ordering of additional blood tests. The pre-analytic stability of biochemistry and immunochemistry analytes has been studied in detail, but little is known about the post-analytical stability in incurred samples. We examined the stability of 23 routine analytes on the Dimension Vista® (Siemens Healthineers, Denmark): 42-60 routine samples in lithium-heparin gel tubes (Vacutainer, BD, USA) were centrifuged at 3000×g for 10min. Immediately after centrifugation, initial concentration of analytes were measured in duplicate (t=0). The tubes were stored decapped at room temperature and re-analyzed after 2, 4, 6, 8 and 10h in singletons. The concentration from reanalysis were normalized to initial concentration (t=0). Internal acceptance criteria for bias and total error were used to determine stability of each analyte. Additionally, evaporation from the decapped blood collection tubes and the residual platelet count in the plasma after centrifugation were quantified. We report a post-analytical stability of most routine analytes of ≥8h and do therefore - with few exceptions - suggest a standard 8hour-time limit for reordering and reanalysis of analytes in incurred samples. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Clinical, biomechanical and morphological assessment of anterior cruciate ligament Kevlar®-based artificial prosthesis in rabbit model.

PubMed

de la Garza-Castro, Santiago; González-Rivera, Carlos E; Vílchez-Cavazos, Félix; Morales-Avalos, Rodolfo; Barrera-Flores, Francisco J; Elizondo-Omaña, Rodrigo E; Soto-Dominguez, Adolfo; Acosta-Olivo, Carlos; Mendoza-Lemus, Oscar F

2017-07-27

The aim of this study was to evaluate the clinical, biomechanical and morphological characteristics of a Kevlar®-based prosthetic ligament as a synthetic graft of the anterior cruciate ligament (ACL) in an experimental animal model in rabbits. A total of 27 knees of rabbits randomly divided into 3 groups (control, ACL excision and ACL replacement with a Kevlar® prosthesis) were analyzed using clinical, biomechanical and morphological tests at 6, 12 and 18 weeks postprocedure. The mean displacement in mechanical testing was 0.73 ± 0.06 mm, 1.58 ± 0.19 mm and 0.94 ± 0.20 mm for the control, ACL excision and ACL replacement with synthetic prosthesis groups, respectively. The results showed an improvement in the stability of the knee with the use of the Kevlar® synthetic prosthesis in the biomechanical testing (p<0.05) compared with rabbits that underwent ACL excision, in addition to displacements that were larger but comparable to that in the control group (p>0.05), between the replacement group and the control group. The histological study revealed a good morphological adaptation of the synthetic material to the knee. This study proposes a new animal model for the placement and evaluation of Kevlar®-based synthetic ACL implants. The studied prosthesis showed promising behavior in the clinical and biomechanical tests and in the histological analysis. This study lays the foundation for further basic and clinical studies of artificial ACL prostheses using this material.

The Effects of Hormonal Contraception on the Voice: History of Its Evolution in the Literature.

PubMed

Rodney, Jennifer P; Sataloff, Robert Thayer

2016-11-01

Women of reproductive age commonly use hormonal contraceptives, the vocal effects of which have been studied. Otolaryngologists should be aware of this relationship to make recommendations on hormonal contraception as it relates to each patient's voice requirements. A comprehensive literature review of PubMed was completed. The terms "contraception," "vocal folds," "vocal cords," and "voice" were searched in various combinations. Articles from 1971 to 2015 that addressed the effects of contraception on the vocal folds were included. In total, 24 articles were available for review. Historically, contraception was believed to affect the voice negatively. However, more recent studies using low-dose oral contraceptive pills (OCPs) show that they stabilize the voice. However, stabilization generally occurs only during sustained vowel production; connected speech appears unaffected. Therefore, singers may be the only population that experiences clinically increased vocal stability as a result of taking hormonal contraceptives. Only combined OCPs have been studied; other forms of hormonal contraception have not been evaluated for effects on the voice. Significant variability exists between studies in the physical attributes of patients and parameters tested. Hormonal contraception likely has no clinically perceptible effects on the speaking voice. Singers may experience increased vocal stability with low-dose, combined OCP use. Other available forms of contraception have not been studied. Greater consistency in methodology is needed in future research, and other forms of hormonal contraception require study. Copyright © 2016 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

Reliability analysis of instrument design of noninvasive bone marrow disease detector

NASA Astrophysics Data System (ADS)

Su, Yu; Li, Ting; Sun, Yunlong

2016-02-01

Bone marrow is an important hematopoietic organ, and bone marrow lesions (BMLs) may cause a variety of complications with high death rate and short survival time. Early detection and follow up care are particularly important. But the current diagnosis methods rely on bone marrow biopsy/puncture, with significant limitations such as invasion, complex operation, high risk, and discontinuous. It is highly in need of a non-invasive, safe, easily operated, and continuous monitoring technology. So we proposed to design a device aimed for detecting bone marrow lesions, which was based on near infrared spectrum technology. Then we fully tested its reliabilities, including the sensitivity, specificity, signal-to-noise ratio (SNR), stability, and etc. Here, we reported this sequence of reliability test experiments, the experimental results, and the following data analysis. This instrument was shown to be very sensitive, with distinguishable concentration less than 0.002 and with good linearity, stability and high SNR. Finally, these reliability-test data supported the promising clinical diagnosis and surgery guidance of our novel instrument in detection of BMLs.

Space shuttle maneuvering engine reusable thrust chamber program. Task 11: Stability analyses and acoustic model testing data dump

NASA Technical Reports Server (NTRS)

Oberg, C. L.

1974-01-01

The combustion stability characteristics of engines applicable to the Space Shuttle Orbit Maneuvering System and the adequacy of acoustic cavities as a means of assuring stability in these engines were investigated. The study comprised full-scale stability rating tests, bench-scale acoustic model tests and analysis. Two series of stability rating tests were made. Acoustic model tests were made to determine the resonance characteristics and effects of acoustic cavities. Analytical studies were done to aid design of the cavity configurations to be tested and, also, to aid evaluation of the effectiveness of acoustic cavities from available test results.

Technical aspects and inter-laboratory variability in native peptide profiling: the CE-MS experience.

PubMed

Mischak, Harald; Vlahou, Antonia; Ioannidis, John P A

2013-04-01

Mass spectrometry platforms have attracted a lot of interest in the last 2 decades as profiling tools for native peptides and proteins with clinical potential. However, limitations associated with reproducibility and analytical robustness, especially pronounced with the initial SELDI systems, hindered the application of such platforms in biomarker qualification and clinical implementation. The scope of this article is to give a short overview on data available on performance and on analytical robustness of the different platforms for peptide profiling. Using the CE-MS platform as a paradigm, data on analytical performance are described including reproducibility (short-term and intermediate repeatability), stability, interference, quantification capabilities (limits of detection), and inter-laboratory variability. We discuss these issues by using as an example our experience with the development of a 273-peptide marker for chronic kidney disease. Finally, we discuss pros and cons and means for improvement and emphasize the need to test in terms of comparative clinical performance and impact, different platforms that pass reasonably well analytical validation tests. Copyright © 2012 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

From preclinical development to clinical application: Kit formulation for radiolabelling the minigastrin analogue CP04 with In-111 for a first-in-human clinical trial.

PubMed

Pawlak, Dariusz; Rangger, Christine; Kolenc Peitl, Petra; Garnuszek, Piotr; Maurin, Michał; Ihli, Laura; Kroselj, Marko; Maina, Theodosia; Maecke, Helmut; Erba, Paola; Kremser, Leopold; Hubalewska-Dydejczyk, Alicja; Mikołajczak, Renata; Decristoforo, Clemens

2016-03-31

A variety of radiolabelled minigastrin analogues targeting the cholecystokinin 2 (CCK2) receptor were developed and compared in a concerted preclinical testing to select the most promising radiotracer for diagnosis and treatment of medullary thyroid carcinoma (MTC). DOTA-DGlu-DGlu-DGlu-DGlu-DGlu-DGlu-Ala-Tyr-Gly-Trp-Met-Asp-Phe-NH2 (CP04) after labelling with (111)In displayed excellent characteristics, such as high stability, receptor affinity, specific and persistent tumour uptake and low kidney retention in animal models. Therefore, it was selected for further clinical evaluation within the ERA-NET project GRAN-T-MTC. Here we report on the development of a pharmaceutical freeze-dried formulation of the precursor CP04 for a first multi-centre clinical trial with (111)In-CP04 in MTC patients. The kit formulation was optimised by adjustment of buffer, additives and radiolabelling conditions. Three clinical grade batches of a final kit formulation with two different amounts of peptide (10 or 50 μg) were prepared and radiolabelled with (111)In. Quality control and stability assays of both the kits and the resulting radiolabelled compound were performed by HPLC analysis. Use of ascorbic acid buffer (pH4.5) allowed freeze-drying of the kit formulation with satisfactory pellet-formation. Addition of methionine and gentisic acid as well as careful selection of radiolabelling temperature was required to avoid extensive oxidation of the Met(11)-residue. Trace metal contamination, in particular Zn, was found to be a major challenge during the pharmaceutical filling process in particular for the 10 μg formulation. The final formulations contained 10 or 50 μg CP04, 25mg ascorbic acid, 0.5mg gentisic acid and 5mg L-methionine. The radiolabelling performed by incubation of 200-250 MBq (111)InCl3 at 90 °C for 15 min resulted in reproducible radiochemical purity (RCP) >94%. Kit-stability was proven for >6 months at +5 °C and at +25 °C. The radiolabelled product was stable for >4h at +25 °C. A kit formulation to prepare (111)In-CP04 for clinical application was developed, showing high stability of the kit as well as high RCP of the final product. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

Effect of Children's Drinks on Color Stability of Different Dental Composites: An in vitro Study.

PubMed

Habib, Ahmed Nour El-Din Ahmed; Abdelmoniem, Soad Abdelmoniem; Mahmoud, Sara Ahmed

To assess the effect of four different children's drinks on color stability of resin dental composites. A total of one hundred and twenty specimens were prepared from Grandio SO, Filtek Z350 XT and Filtek Z250 XT (forty specimens each). Specimens were thermocycled, then each group was further subdivided into four subgroups (n=10) according to the immersion media which were chocolate milk, mango juice, orange fizzy drink, and water (control). The initial color parameters of each specimen were recorded before immersion (baseline) and color change values were recorded three and seven days after immersion in each solution using a digital spectrophotometer. Atomic force microscope was used to measure the surface roughness in randomly selected samples after one week immersion in children's drinks. All the children's drinks produced color changes in the examined resin dental composites, yet there was no statistical significant difference between the effects of tested drinks on the color changes (mean ΔE) of the three different dental composites (P>0.05). All tested children's drinks caused clinically unacceptable color changes of the tested resin dental composites. Immersion in chocolate milk and orange fizzy led to the highest color changes in the tested resin dental composites.

Generator Set Environmental and Stability Testing

DTIC Science & Technology

2015-03-01

UNCLASSIFIED GENERATOR SET ENVIRONMENTAL AND STABILITY TESTING INTERIM REPORT TFLRF No. 460 by Gregory A. Hansen Edwin A...it to the originator. UNCLASSIFIED GENERATOR SET ENVIRONMENTAL AND STABILITY TESTING INTERIM REPORT TFLRF No. 460 by...TITLE AND SUBTITLE Generator Set Environmental and Stability Testing 5a. CONTRACT NUMBER W56HZV-09-C-0100 5b. GRANT NUMBER 5c. PROGRAM

Assessment of Dry Epidermal Electrodes for Long-Term Electromyography Measurements

PubMed Central

Peters, Keshia M.; Milovanovic, Ivana; Kuang, Irene; Yang, Zeyu; Lu, Nanshu; Steele, Katherine M.

2018-01-01

Commercially available electrodes can only provide quality surface electromyography (sEMG) measurements for a limited duration due to user discomfort and signal degradation, but in many applications, collecting sEMG data for a full day or longer is desirable to enhance clinical care. Few studies for long-term sEMG have assessed signal quality of electrodes using clinically relevant tests. The goal of this research was to evaluate flexible, gold-based epidermal sensor system (ESS) electrodes for long-term sEMG recordings. We collected sEMG and impedance data from eight subjects from ESS and standard clinical electrodes on upper extremity muscles during maximum voluntary isometric contraction tests, dynamic range of motion tests, the Jebsen Taylor Hand Function Test, and the Box & Block Test. Four additional subjects were recruited to test the stability of ESS signals over four days. Signals from the ESS and traditional electrodes were strongly correlated across tasks. Measures of signal quality, such as signal-to-noise ratio and signal-to-motion ratio, were also similar for both electrodes. Over the four-day trial, no significant decrease in signal quality was observed in the ESS electrodes, suggesting that thin, flexible electrodes may provide a robust tool that does not inhibit movement or irritate the skin for long-term measurements of muscle activity in rehabilitation and other applications. PMID:29677129

16 CFR Figure 7 to Part 1203 - Typical Test Apparatus for Positional Stability Test

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Typical Test Apparatus for Positional Stability Test 7 Figure 7 to Part 1203 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER...—Typical Test Apparatus for Positional Stability Test ER10MR98.007 ...

16 CFR Figure 7 to Part 1203 - Typical Test Apparatus for Positional Stability Test

Code of Federal Regulations, 2011 CFR

2011-01-01

... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Typical Test Apparatus for Positional Stability Test 7 Figure 7 to Part 1203 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER...—Typical Test Apparatus for Positional Stability Test ER10MR98.007 ...

A PILOT STUDY OF CORE STABILITY AND ATHLETIC PERFORMANCE: IS THERE A RELATIONSHIP?

PubMed Central

Sharrock, Chris; Cropper, Jarrod; Mostad, Joel; Johnson, Matt

2011-01-01

Study Design: Correlation study Objectives: To objectively evaluate the relationship between core stability and athletic performance measures in male and female collegiate athletes. Background: The relationship between core stability and athletic performance has yet to be quantified in the available literature. The current literature does not demonstrate whether or not core strength relates to functional performance. Questions remain regarding the most important components of core stability, the role of sport specificity, and the measurement of core stability in relation to athletic performance. Methods: A sample of 35 volunteer student athletes from Asbury College (NAIA Division II) provided informed consent. Participants performed a series of five tests: double leg lowering (core stability test), the forty yard dash, the T-test, vertical jump, and a medicine ball throw. Participants performed three trials of each test in a randomized order. Results: Correlations between the core stability test and each of the other four performance tests were determined using a General Linear Model. Medicine ball throw negatively correlated to the core stability test (r –0.389, p=0.023). Participants that performed better on the core stability test had a stronger negative correlation to the medicine ball throw (r =–0.527). Gender was the most strongly correlated variable to core strength, males with a mean measurement of double leg lowering of 47.43 degrees compared to females having a mean of 54.75 degrees. Conclusions: There appears to be a link between a core stability test and athletic performance tests; however, more research is needed to provide a definitive answer on the nature of this relationship. Ideally, specific performance tests will be able to better define and to examine relationships to core stability. Future studies should also seek to determine if there are specific sub-categories of core stability which are most important to allow for optimal training and performance for individual sports. PMID:21713228

Top ten challenges when interfacing a laboratory information system to an electronic health record: Experience at a large academic medical center.

PubMed

Petrides, Athena K; Tanasijevic, Milenko J; Goonan, Ellen M; Landman, Adam B; Kantartjis, Michalis; Bates, David W; Melanson, Stacy E F

2017-10-01

Recent U.S. government regulations incentivize implementation of an electronic health record (EHR) with computerized order entry and structured results display. Many institutions have also chosen to interface their EHR to their laboratory information system (LIS). Reported long-term benefits include increased efficiency and improved quality and safety. In order to successfully implement an interfaced EHR-LIS, institutions must plan years in advance and anticipate the impact of an integrated system. It can be challenging to fully understand the technical, workflow and resource aspects and adequately prepare for a potentially protracted system implementation and the subsequent stabilization. We describe the top ten challenges that we encountered in our clinical laboratories following the implementation of an interfaced EHR-LIS and offer suggestions on how to overcome these challenges. This study was performed at a 777-bed, tertiary care center which recently implemented an interfaced EHR-LIS. Challenges were recorded during EHR-LIS implementation and stabilization and the authors describe the top ten. Our top ten challenges were selection and harmonization of test codes, detailed training for providers on test ordering, communication with EHR provider champions during the build process, fluid orders and collections, supporting specialized workflows, sufficient reports and metrics, increased volume of inpatient venipunctures, adequate resources during stabilization, unanticipated changes to laboratory workflow and ordering specimens for anatomic pathology. A few suggestions to overcome these challenges include regular meetings with clinical champions, advanced considerations of reports and metrics that will be needed, adequate training of laboratory staff on new workflows in the EHR and defining all tests including anatomic pathology in the LIS. EHR-LIS implementations have many challenges requiring institutions to adapt and develop new infrastructures. This article should be helpful to other institutions facing or undergoing a similar endeavor. Copyright © 2017 Elsevier B.V. All rights reserved.

Analysis of the postural stability in individuals with or without signs and symptoms of temporomandibular disorder.

PubMed

Ries, Lilian Gerdi Kittel; Bérzin, Fausto

2008-01-01

The objective of this study was to evaluate the stability and the distribution of weight of individuals with TMD (Temporomandibular Disorder) when placed in an orthostatic position. Forty female volunteers, participating in this study, were distributed into a control and a TMD group. Clinical examinations of the craniomandibular system and of the neck were performed. Postural stability was evaluated using a stabilographic platform. Through this system, the sway index (SI), the maximum medial-lateral distance (MMLD), the maximum anterior-posterior distance (MAPD) and the medial-lateral symmetry (MLS) could be determined. Tests were performed in the mandibular rest position and during isometric and isotonic contraction. The variables were analyzed through repeated measures ANOVA. The level of significance was p < 0.05. The results of this study indicate that individuals with TMD present more pain in the cervical region (p < 0.05). The group with TMD showed a significant reduction in SI (p < 0.05), MMLD (p < 0.05) and MLS (p < 0.01). Individuals with TMD presented greater postural asymmetry, and cervical pain demonstrated a potential link with an increase in postural stability.

[Design and experiment of micro biochemical detector based on micro spectrometer].

PubMed

Yu, Qing-hua; Wen, Zhi-yu; Chen, Gang; Dai, Wei-wei; Liu, Nian-ci; Wu, Xin

2012-03-01

According to the requirements of rapid detection of important life parameters for the sick and wounded, a new micro bio-chemical detection configuration was proposed utilizing continuous spectroscopy analysis, which was founded on MOEMS and embedded technology. The configuration was developed as so much research work was carried out on the detecting objects and methods. Important parameters such as stray light, absorbance linearity, absorbance ratability, stability and temperature accuracy of the instrument were tested, which are all in good agreement with the design requirements. Clinic tests show that it can detect multiple life parameters quickly (Na+, GLU, Hb eg.).

Prospective randomized clinical trial of hydrophilic tapered implant placement at maxillary posterior area: 6 weeks and 12 weeks loading

PubMed Central

2016-01-01

PURPOSE Early loading of implant can be determined by excellent primary stability and characteristic of implant surface. The implant system with recently improved surface can have load application 4-6 weeks after installing in maxilla and mandible. This study evaluated the effect of healing period to the stability of hydrophilic tapered-type implant at maxillary posterior area. MATERIALS AND METHODS This study included 30 patients treated by hydrophilic tapered-type implants (total 41 implants at maxilla) and classified by two groups depending on healing period. Group 1 (11 patients, 15 implants) was a control group and the healing period was 12 weeks, and Group 2 (19 patients, 26 implants) was test group and the healing period was 6 weeks. Immediately after implant placement, at the first impression taking, implant stability was measured using Osstell Mentor. The patients also took periapical radiographs after restoration delivery, 12 months after restoration and final followup period. The marginal bone loss around the implants was measured using the periapical radiographs. RESULTS All implants were survived and success rate was 97.56%. The marginal bone loss was less than 1mm after 1 year postoperatively except the one implant. The stabilities of the implants were not correlated with age, healing period until loading, insertion torque (IT), the diameter of fixture and the location of implant. Only the quality of bone in group 2 (6 week) was correlated with the stability of implant. CONCLUSION Healing period of 6 weeks can make the similar clinical prognosis of implants to that of healing period of 12 weeks if bone quality is carefully considered in case of early loading. PMID:27826390

Posturography and risk of recurrent falls in healthy non-institutionalized persons aged over 65.

PubMed

Buatois, Séverine; Gueguen, René; Gauchard, Gérome C; Benetos, Athanase; Perrin, Philippe P

2006-01-01

A poor postural stability in older people is associated with an increased risk of falling. The posturographic tool has widely been used to assess balance control; however, its value in predicting falls remains unclear. The purpose of this prospective study was to determine the predictive value of posturography in the estimation of the risk of recurrent falls, including a comparison with standard clinical balance tests, in healthy non-institutionalized persons aged over 65. Two hundred and six healthy non-institutionalized volunteers aged over 65 were tested. Postural control was evaluated by posturographic tests, performed on static, dynamic and dynamized platforms (static test, slow dynamic test and Sensory Organization Test [SOT]) and clinical balance tests (Timed 'Up & Go' test, One-Leg Balance, Sit-to-Stand-test). Subsequent falls were monitored prospectively with self-questionnaire sent every 4 months for a period of 16 months after the balance testing. Subjects were classified prospectively in three groups of Non-Fallers (0 fall), Single-Fallers (1 fall) and Multi-Fallers (more than 2 falls). Loss of balance during the last trial of the SOT sensory conflicting condition, when visual and somatosensory inputs were distorted, was the best factor to predict the risk of recurrent falls (OR = 3.6, 95% CI = 1.3-10.11). Multi-Fallers showed no postural adaptation during the repetitive trials of this sensory condition, contrary to Non-Fallers and Single-Fallers. The Multi-Fallers showed significantly more sway when visual inputs were occluded. The clinical balance tests, the static test and the slow dynamic test revealed no significant differences between the groups. In a sample of non-institutionalized older persons aged over 65, posturographic evaluation by the SOT, especially with repetition of the same task in sensory conflicting condition, compared to the clinical tests and the static and dynamic posturographic test, appears to be a more sensitive tool to identify those at high-risk of recurrent falls. Copyright (c) 2006 S. Karger AG, Basel.

Validation of Mismatch Negativity and P3a for Use in Multi-Site Studies of Schizophrenia: Characterization of Demographic, Clinical, Cognitive, and Functional Correlates in COGS-2

PubMed Central

Light, Gregory A.; Swerdlow, Neal R.; Thomas, Michael L.; Calkins, Monica E.; Green, Michael F.; Greenwood, Tiffany A.; Gur, Raquel E.; Gur, Ruben C.; Lazzeroni, Laura C.; Nuechterlein, Keith H.; Pela, Marlena; Radant, Allen D.; Seidman, Larry J.; Sharp, Richard F.; Siever, Larry J.; Silverman, Jeremy M.; Sprock, Joyce; Stone, William S.; Sugar, Catherine A.; Tsuang, Debby W.; Tsuang, Ming T.; Braff, David L.; Turetsky, Bruce I.

2014-01-01

Mismatch negativity (MMN) and P3a are auditory event-related potential (ERP) components that show robust deficits in schizophrenia (SZ) patients and exhibit qualities of endophenotypes, including substantial heritability, test-retest reliability, and trait-like stability. These measures also fulfill criteria for use as cognition and function-linked biomarkers in outcome studies, but have not yet been validated for use in large-scale multi-site clinical studies. This study tested the feasibility of adding MMN and P3a to the ongoing Consortium on the Genetics of Schizophrenia (COGS) study. The extent to which demographic, clinical, cognitive, and functional characteristics contribute to variability in MMN and P3a amplitudes was also examined. Participants (HCS n=824, SZ n=966) underwent testing at 5 geographically distributed COGS laboratories. Valid ERP data was obtained from 91% of HCS and 91% of SZ patients. Highly significant MMN (d=0.96) and P3a (d=0.93) amplitude reductions were observed in SZ patients, comparable in magnitude to those observed in single-lab studies with no appreciable differences across laboratories. Demographic characteristics accounted for 26% and 18% of the variance in MMN and P3a amplitudes, respectively. Significant relationships were observed among demographically-adjusted MMN and P3a measures and medication status as well as several clinical, cognitive, and functional characteristics of the SZ patients. This study demonstrates that MMN and P3a ERP biomarkers can be feasibly used in multi-site clinical studies. As with many clinical tests of brain function, demographic factors contribute to MMN and P3a amplitudes and should be carefully considered in future biomarker-informed clinical studies. PMID:25449710

Validation of mismatch negativity and P3a for use in multi-site studies of schizophrenia: characterization of demographic, clinical, cognitive, and functional correlates in COGS-2.

PubMed

Light, Gregory A; Swerdlow, Neal R; Thomas, Michael L; Calkins, Monica E; Green, Michael F; Greenwood, Tiffany A; Gur, Raquel E; Gur, Ruben C; Lazzeroni, Laura C; Nuechterlein, Keith H; Pela, Marlena; Radant, Allen D; Seidman, Larry J; Sharp, Richard F; Siever, Larry J; Silverman, Jeremy M; Sprock, Joyce; Stone, William S; Sugar, Catherine A; Tsuang, Debby W; Tsuang, Ming T; Braff, David L; Turetsky, Bruce I

2015-04-01

Mismatch negativity (MMN) and P3a are auditory event-related potential (ERP) components that show robust deficits in schizophrenia (SZ) patients and exhibit qualities of endophenotypes, including substantial heritability, test-retest reliability, and trait-like stability. These measures also fulfill criteria for use as cognition and function-linked biomarkers in outcome studies, but have not yet been validated for use in large-scale multi-site clinical studies. This study tested the feasibility of adding MMN and P3a to the ongoing Consortium on the Genetics of Schizophrenia (COGS) study. The extent to which demographic, clinical, cognitive, and functional characteristics contribute to variability in MMN and P3a amplitudes was also examined. Participants (HCS n=824, SZ n=966) underwent testing at 5 geographically distributed COGS laboratories. Valid ERP recordings were obtained from 91% of HCS and 91% of SZ patients. Highly significant MMN (d=0.96) and P3a (d=0.93) amplitude reductions were observed in SZ patients, comparable in magnitude to those observed in single-lab studies with no appreciable differences across laboratories. Demographic characteristics accounted for 26% and 18% of the variance in MMN and P3a amplitudes, respectively. Significant relationships were observed among demographically-adjusted MMN and P3a measures and medication status as well as several clinical, cognitive, and functional characteristics of the SZ patients. This study demonstrates that MMN and P3a ERP biomarkers can be feasibly used in multi-site clinical studies. As with many clinical tests of brain function, demographic factors contribute to MMN and P3a amplitudes and should be carefully considered in future biomarker-informed clinical studies. Published by Elsevier B.V.

Biochemical Phenotypes to Discriminate Microbial Subpopulations and Improve Outbreak Detection

PubMed Central

Galar, Alicia; Kulldorff, Martin; Rudnick, Wallis; O'Brien, Thomas F.; Stelling, John

2013-01-01

Background Clinical microbiology laboratories worldwide constitute an invaluable resource for monitoring emerging threats and the spread of antimicrobial resistance. We studied the growing number of biochemical tests routinely performed on clinical isolates to explore their value as epidemiological markers. Methodology/Principal Findings Microbiology laboratory results from January 2009 through December 2011 from a 793-bed hospital stored in WHONET were examined. Variables included patient location, collection date, organism, and 47 biochemical and 17 antimicrobial susceptibility test results reported by Vitek 2. To identify biochemical tests that were particularly valuable (stable with repeat testing, but good variability across the species) or problematic (inconsistent results with repeat testing), three types of variance analyses were performed on isolates of K. pneumonia: descriptive analysis of discordant biochemical results in same-day isolates, an average within-patient variance index, and generalized linear mixed model variance component analysis. Results: 4,200 isolates of K. pneumoniae were identified from 2,485 patients, 32% of whom had multiple isolates. The first two variance analyses highlighted SUCT, TyrA, GlyA, and GGT as “nuisance” biochemicals for which discordant within-patient test results impacted a high proportion of patient results, while dTAG had relatively good within-patient stability with good heterogeneity across the species. Variance component analyses confirmed the relative stability of dTAG, and identified additional biochemicals such as PHOS with a large between patient to within patient variance ratio. A reduced subset of biochemicals improved the robustness of strain definition for carbapenem-resistant K. pneumoniae. Surveillance analyses suggest that the reduced biochemical profile could improve the timeliness and specificity of outbreak detection algorithms. Conclusions The statistical approaches explored can improve the robust recognition of microbial subpopulations with routinely available biochemical test results, of value in the timely detection of outbreak clones and evolutionarily important genetic events. PMID:24391936

Does Anteromedial Portal Drilling Improve Footprint Placement in Anterior Cruciate Ligament Reconstruction?

PubMed

Arno, Sally; Bell, Christopher P; Alaia, Michael J; Singh, Brian C; Jazrawi, Laith M; Walker, Peter S; Bansal, Ankit; Garofolo, Garret; Sherman, Orrin H

2016-07-01

Considerable debate remains over which anterior cruciate ligament (ACL) reconstruction technique can best restore knee stability. Traditionally, femoral tunnel drilling has been done through a previously drilled tibial tunnel; however, potential nonanatomic tunnel placement can produce a vertical graft, which although it would restore sagittal stability, it would not control rotational stability. To address this, some suggest that the femoral tunnel be created independently of the tibial tunnel through the use of an anteromedial (AM) portal, but whether this results in a more anatomic footprint or in stability comparable to that of the intact contralateral knee still remains controversial. (1) Does the AM technique achieve footprints closer to anatomic than the transtibial (TT) technique? (2) Does the AM technique result in stability equivalent to that of the intact contralateral knee? (3) Are there differences in patient-reported outcomes between the two techniques? Twenty male patients who underwent a bone-patellar tendon-bone autograft were recruited for this study, 10 in the TT group and 10 in the AM group. Patients in each group were randomly selected from four surgeons at our institution with both groups demonstrating similar demographics. The type of procedure chosen for each patient was based on the preferred technique of the surgeon. Some surgeons exclusively used the TT technique, whereas other surgeons specifically used the AM technique. Surgeons had no input on which patients were chosen to participate in this study. Mean postoperative time was 13 ± 2.8 and 15 ± 3.2 months for the TT and AM groups, respectively. Patients were identified retrospectively as having either the TT or AM Technique from our institutional database. At followup, clinical outcome scores were gathered as well as the footprint placement and knee stability assessed. To assess the footprint placement and knee stability, three-dimensional surface models of the femur, tibia, and ACL were created from MRI scans. The femoral and tibial footprints of the ACL reconstruction as compared with the intact contralateral ACL were determined. In addition, the AP displacement and rotational displacement of the femur were determined. Lastly, as a secondary measurement of stability, KT-1000 measurements were obtained at the followup visit. An a priori sample size calculation indicated that with 2n = 20 patients, we could detect a difference of 1 mm with 80% power at p < 0.05. A Welch two-sample t-test (p < 0.05) was performed to determine differences in the footprint measurements, AP displacement, rotational displacement, and KT-1000 measurements between the TT and AM groups. We further used the confidence interval approach with 90% confidence intervals on the pairwise mean group differences using a Games-Howell post hoc test to assess equivalence between the TT and AM groups for the previously mentioned measures. The AM and TT techniques were the same in terms of footprint except in the distal-proximal location of the femur. The TT for the femoral footprint (DP%D) was 9% ± 6%, whereas the AM was -1% ± 13% (p = 0.04). The TT technique resulted in a more proximal footprint and therefore a more vertical graft compared with intact ACL. The AP displacement and rotation between groups were the same and clinical outcomes did not demonstrate a difference. Although the AM portal drilling may place the femoral footprint in a more anatomic position, clinical stability and outcomes may be similar as long as attempts are made at creating an anatomic position of the graft. Level III, therapeutic study.

Relative and absolute reliability of the clinical version of the Narrow Path Walking Test (NPWT) under single and dual task conditions.

PubMed

Gimmon, Yoav; Jacob, Grinshpon; Lenoble-Hoskovec, Constanze; Büla, Christophe; Melzer, Itshak

2013-01-01

Decline in gait stability has been associated with increased fall risk in older adults. Reliable and clinically feasible methods of gait instability assessment are needed. This study evaluated the relative and absolute reliability and concurrent validity of the testing procedure of the clinical version of the Narrow Path Walking Test (NPWT) under single task (ST) and dual task (DT) conditions. Thirty independent community-dwelling older adults (65-87 years) were tested twice. Participants were instructed to walk within the 6-m narrow path without stepping out. Trial time, number of steps, trial velocity, number of step errors, and number of cognitive task errors were determined. Intraclass correlation coefficients (ICCs) were calculated as indices of agreement, and a graphic approach called "mountain plot" was applied to help interpret the direction and magnitude of disagreements between testing procedures. Smallest detectable change and smallest real difference (SRD) were computed to determine clinically relevant improvement at group and individual levels, respectively. Concurrent validity was assessed using Performance Oriented Mobility Assessment Tool (POMA) and the Short Physical Performance Battery (SPPB). Test-retest agreement (ICC1,2) varied from 0.77 to 0.92 in ST and from 0.78 to 0.92 in DT conditions, with no apparent systematic differences between testing procedures demonstrated by the mountain plot graphs. Smallest detectable change and smallest real change were small for motor task performance and larger for cognitive errors. Significant correlations were observed for trial velocity and trial time with POMA and SPPB. The present results indicate that the NPWT testing procedure is highly reliable and reproducible. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

The stabilizing potential of anterior, posterior and combined techniques for the reconstruction of a 2-level cervical corpectomy model: biomechanical study and first results of ATPS prototyping.

PubMed

Koller, Heiko; Schmidt, Rene; Mayer, Michael; Hitzl, Wolfgang; Zenner, Juliane; Midderhoff, Stefan; Middendorf, Stefan; Graf, Nicolaus; Gräf, Nicolaus; Resch, H; Wilke, Hans-Joachim; Willke, Hans-Joachim

2010-12-01

Clinical studies reported frequent failure with anterior instrumented multilevel cervical corpectomies. Hence, posterior augmentation was recommended but necessitates a second approach. Thus, an author group evaluated the feasibility, pull-out characteristics, and accuracy of anterior transpedicular screw (ATPS) fixation. Although first success with clinical application of ATPS has already been reported, no data exist on biomechanical characteristics of an ATPS-plate system enabling transpedicular end-level fixation in advanced instabilities. Therefore, we evaluated biomechanical qualities of an ATPS prototype C4-C7 for reduction of range of motion (ROM) and primary stability in a non-destructive setup among five constructs: anterior plate, posterior all-lateral mass screw construct, posterior construct with lateral mass screws C5 + C6 and end-level fixation using pedicle screws unilaterally or bilaterally, and a 360° construct. 12 human spines C3-T1 were divided into two groups. Four constructs were tested in group 1 and three in group 2; the ATPS prototypes were tested in both groups. Specimens were subjected to flexibility test in a spine motion tester at intact state and after 2-level corpectomy C5-C6 with subsequent reconstruction using a distractable cage and one of the osteosynthesis mentioned above. ROM in flexion-extension, axial rotation, and lateral bending was reported as normalized values. All instrumentations but the anterior plate showed significant reduction of ROM for all directions compared to the intact state. The 360° construct outperformed all others in terms of reducing ROM. While there were no significant differences between the 360° and posterior constructs in flexion-extension and lateral bending, the 360° constructs were significantly more stable in axial rotation. Concerning primary stability of ATPS prototypes, there were no significant differences compared to posterior-only constructs in flexion-extension and axial rotation. The 360° construct showed significant differences to the ATPS prototypes in flexion-extension, while no significant differences existed in axial rotation. But in lateral bending, the ATPS prototype and the anterior plate performed significantly worse than the posterior constructs. ATPS was shown to confer increased primary stability compared to the anterior plate in flexion-extension and axial rotation with the latter yielding significance. We showed that primary stability after 2-level corpectomy reconstruction using ATPS prototypes compared favorably to posterior systems and superior to anterior plates. From the biomechanical point, the 360° instrumentation was shown the most efficient for reconstruction of 2-level corpectomies. Further studies will elucidate whether fatigue testing will enhance the benefit of transpedicular anchorage with posterior constructs and ATPS.

Narrowing beam-walking is a clinically feasible approach for assessing balance ability in lower-limb prosthesis users.

PubMed

Sawers, Andrew; Hafner, Brian J

2018-05-08

Challenging clinical balance tests are needed to expose balance deficits in lower-limb prost-hesis users. This study examined whether narrowing beam-walking could overcome conceptual and practical limitations identified in fixed-width beam-walking. Cross-sectional. Unilateral lower-limb prosthesis users. Participants walked 10 times along a low, narrowing beam. Performance was quantified using the normalized distance walked. Heuristic rules were applied to determine whether the narrowing beam task was "too easy," "too hard," or "appropriately challenging" for each participant. Linear regression and Bland-Altman plots were used to determine whether combinations of the first 5 trials could predict participants' stable beam-walking performance. Forty unilateral lower-limb prosthesis users participated. Narrowing beam-walking was appropriately challenging for 98% of participants. Performance stabilized for 93% of participants within 5 trials, while 62% were stable across all trials. The mean of trials 3-5 accurately predicted stable performance. A clinical narrowing beam-walking test is likely to challenge a range of lower-limb prosthesis users, have minimal administrative burden, and exhibit no floor or ceiling effects. Narrowing beam-walking is therefore a clinically viable method to evaluate lower-limb prosthesis users' balance ability, but requires psychometric testing before it is used to assess fall risk.

Color stability of shade guides after autoclave sterilization.

PubMed

Schmeling, Max; Sartori, Neimar; Monteiro, Sylvio; Baratieri, Luiz

2014-01-01

This study evaluated the influence of 120 autoclave sterilization cycles on the color stability of two commercial shade guides (Vita Classical and Vita System 3D-Master). The specimens were evaluated by spectrophotometer before and after the sterilization cycles. The color was described using the three-dimensional CIELab system. The statistical analysis was performed in three chromaticity coordinates, before and after sterilization cycles, using the paired samples t test. All specimens became darker after autoclave sterilization cycles. However, specimens of Vita Classical became redder, while those of the Vita System 3D-Master became more yellow. Repeated cycles of autoclave sterilization caused statistically significant changes in the color coordinates of the two shade guides. However, these differences are considered clinically acceptable.

16 CFR § 1203.15 - Positional stability test (roll-off resistance).

Code of Federal Regulations, 2013 CFR

2013-01-01

... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Positional stability test (roll-off... stability test (roll-off resistance). (a) Test equipment. (1) Headforms. The test headforms shall comply with the dimensions of the full chin ISO reference headforms sizes A, E, J, M, and O. (2) Test fixture...

A Systematic Review of Clinical Functional Outcomes After Medial Stabilized Versus Non-Medial Stabilized Total Knee Joint Replacement

PubMed Central

Young, Tony; Dowsey, Michelle M.; Pandy, Marcus; Choong, Peter F.

2018-01-01

Background Medial stabilized total knee joint replacement (TKJR) construct is designed to closely replicate the kinematics of the knee. Little is known regarding comparison of clinical functional outcomes of patients utilising validated patient reported outcome measures (PROM) after medial stabilized TKJR and other construct designs. Purpose To perform a systematic review of the available literature related to the assessment of clinical functional outcomes following a TKJR employing a medial stabilized construct design. Methods The review was performed with a Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) algorithm. The literature search was performed using variouscombinations of keywords. The statistical analysis was completed using Review Manager (RevMan), Version 5.3. Results In the nineteen unique studies identified, there were 2,448 medial stabilized TKJRs implanted in 2,195 participants, there were 1,777 TKJRs with non-medial stabilized design constructs implanted in 1,734 subjects. The final mean Knee Society Score (KSS) value in the medial stabilized group was 89.92 compared to 90.76 in the non-medial stabilized group, with the final KSS mean value difference between the two groups was statistically significant and favored the non-medial stabilized group (SMD 0.21; 95% CI: 0.01 to 0.41; p = 004). The mean difference in the final WOMAC values between the two groups was also statistically significant and favored the medial stabilized group (SMD: −0.27; 95% CI: −0.47 to −0.07; p = 0.009). Moderate to high values (I2) of heterogeneity were observed during the statistical comparison of these functional outcomes. Conclusion Based on the small number of studies with appropriate statistical analysis, we are unable to reach a clear conclusion in the clinical performance of medial stabilized knee replacement construct. Level of Evidence Level II PMID:29696144

A Systematic Review of Clinical Functional Outcomes After Medial Stabilized Versus Non-Medial Stabilized Total Knee Joint Replacement.

PubMed

Young, Tony; Dowsey, Michelle M; Pandy, Marcus; Choong, Peter F

2018-01-01

Medial stabilized total knee joint replacement (TKJR) construct is designed to closely replicate the kinematics of the knee. Little is known regarding comparison of clinical functional outcomes of patients utilising validated patient reported outcome measures (PROM) after medial stabilized TKJR and other construct designs. To perform a systematic review of the available literature related to the assessment of clinical functional outcomes following a TKJR employing a medial stabilized construct design. The review was performed with a Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) algorithm. The literature search was performed using variouscombinations of keywords. The statistical analysis was completed using Review Manager (RevMan), Version 5.3. In the nineteen unique studies identified, there were 2,448 medial stabilized TKJRs implanted in 2,195 participants, there were 1,777 TKJRs with non-medial stabilized design constructs implanted in 1,734 subjects. The final mean Knee Society Score (KSS) value in the medial stabilized group was 89.92 compared to 90.76 in the non-medial stabilized group, with the final KSS mean value difference between the two groups was statistically significant and favored the non-medial stabilized group (SMD 0.21; 95% CI: 0.01 to 0.41; p = 004). The mean difference in the final WOMAC values between the two groups was also statistically significant and favored the medial stabilized group (SMD: -0.27; 95% CI: -0.47 to -0.07; p = 0.009). Moderate to high values ( I 2 ) of heterogeneity were observed during the statistical comparison of these functional outcomes. Based on the small number of studies with appropriate statistical analysis, we are unable to reach a clear conclusion in the clinical performance of medial stabilized knee replacement construct. Level II.

46 CFR 42.09-10 - Stability, subdivision, and strength.

Code of Federal Regulations, 2012 CFR

2012-10-01

... approval of test results (light ship data) and stability information shall be furnished by the owner. In... a stability test performed under the supervision of the Commandant. Results of such tests, if... 46 Shipping 2 2012-10-01 2012-10-01 false Stability, subdivision, and strength. 42.09-10 Section...

46 CFR 42.09-10 - Stability, subdivision, and strength.

Code of Federal Regulations, 2014 CFR

2014-10-01

... approval of test results (light ship data) and stability information shall be furnished by the owner. In... a stability test performed under the supervision of the Commandant. Results of such tests, if... 46 Shipping 2 2014-10-01 2014-10-01 false Stability, subdivision, and strength. 42.09-10 Section...

46 CFR 42.09-10 - Stability, subdivision, and strength.

Code of Federal Regulations, 2013 CFR

2013-10-01

... approval of test results (light ship data) and stability information shall be furnished by the owner. In... a stability test performed under the supervision of the Commandant. Results of such tests, if... 46 Shipping 2 2013-10-01 2013-10-01 false Stability, subdivision, and strength. 42.09-10 Section...

Guidelines for the practical stability studies of anticancer drugs: a European consensus conference.

PubMed

Bardin, C; Astier, A; Vulto, A; Sewell, G; Vigneron, J; Trittler, R; Daouphars, M; Paul, M; Trojniak, M; Pinguet, F

2011-07-01

Stability studies performed by the pharmaceutical industry are only designed to fulfill licensing requirements. Thus, post-dilution or -reconstitution stability data are frequently limited to 24h only for bacteriological reasons regardless of the true chemical stability which could, in many cases, be longer. In practice, the pharmacy-based centralized preparation may require infusions to be made several days in advance to provide, for example, the filling of ambulatory devices for continuous infusions or batch preparations for dose banding. Furthermore, a non-justified limited stability for expensive products is obviously very costly. Thus, there is a compelling need for additional stability data covering practical uses of anticancer drugs. A European conference consensus was held in France, May 2010, under the auspices of the French Society of Oncology Pharmacy (SFPO) to propose adapted rules on stability in practical situations and guidelines to perform corresponding stability studies. For each anticancer drug, considering their therapeutic index, the pharmacokinetics/pharmacodynamics (PK/PD) variability, specific clinical use and risks related to degradation products, the classical limit of 10% of degradation can be inappropriate. Therefore, acceptance limits must be clinically relevant and should be defined for each drug individually. Design of stability studies has to reflect the different needs of the clinical practice (preparation for the week-ends, outpatient transportations, implantable devices, dose banding…). It is essential to use validated stability-indicating methods, separating degradation products being formed in the practical use of the drug. Sequential temperature designs should be encouraged to replicate problems seen in daily practice such as rupture of the cold-chain or temperature-cycling between refrigerated storage and ambient in-use conditions. Stressed conditions are recommended to evaluate not only the role of classical variables (pH, temperature, light) but also the mechanical stress. Physical stability such as particles' formation should be systematically evaluated. The consensus conference focused on the need to perform more studies on the stability of biotherapies, including a minimum of three complementary separating methods and a careful evaluation of submicron aggregates. The determination of the biological activity of proteins could be also useful. A guideline on the practical stability of anticancer drugs is proposed to cover current clinical and pharmaceutical practice. It should contribute to improved security of use, optimization of centralized handling and reduced costs. Finally, we have attempted to establish a new drug stability paradigm based on practical clinical needs, to complement regulatory guidelines which are essentially orientated to the stability of manufactured drugs. Copyright © 2011 Elsevier Masson SAS. All rights reserved.

Modification of elastic stable intramedullary nailing with a 3rd nail in a femoral spiral fracture model - results of biomechanical testing and a prospective clinical study.

PubMed

Kaiser, Martin M; Stratmann, Christine; Zachert, Gregor; Schulze-Hessing, Maaike; Gros, Nina; Eggert, Rebecca; Rapp, Marion

2014-01-08

Elastic stable intramedullary nailing (ESIN) is the standard treatment for displaced diaphyseal femoral fractures in children. However, high complication rates (10-50%) are reported in complex fractures. This biomechanical study compares the stiffness with a 3rd nail implanted to that in the classical 2C-shaped configuration and presents the application into clinical practice. For each of the 3 configurations of ESIN-osteosynthesis with titanium nails eight composite femoral grafts (Sawbones®) with an identical spiral fracture were used: 2C configuration (2C-shaped nails, 2 × 3.5 mm), 3CM configuration (3rd nail from medial) and 3CL configuration (3rd nail from lateral). Each group underwent biomechanical testing in 4-point bending, internal/external rotation and axial compression. 2C and 3CM configurations showed no significant differences in this spiroid type fracture model. 3CL had a significantly higher stiffness during anterior-posterior bending, internal rotation and 9° compression than 2C, and was stiffer in the lateral-medial direction than 3CM. The 3CL was less stable during p-a bending and external rotation than both the others. As biomechanical testing showed a higher stability for the 3CL configuration in two (a-p corresponding to recurvation and 9° compression to shortening) of three directions associated with the most important clinical problems, we added a 3rd nail in ESIN-osteosynthesis for femoral fractures. 11 boys and 6 girls (2.5-15 years) were treated with modified ESIN of whom 12 were '3CL'; due to the individual character of the fractures 4 patients were treated with '3CM' (third nail from medial) and as an exception 1 adolescent with 4 nails and one boy with plate osteosynthesis. No additional stabilizations or re-operations were necessary. All patients achieved full points in the Harris-Score at follow-up; no limb length discrepancy occurred. The 3CL configuration provided a significantly higher stiffness than 2C and 3CM configurations in this biomechanical model. These results were successfully transmitted into clinical practice. All children, treated by 3CL or 3CM according to the individual character of each fracture, needed no additional stabilization and had no Re-Do operations. As a consequence, at our hospital all children with femoral diaphyseal fractures with open physis are treated with this modified ESIN-technique.

Knee joint kinematics after dynamic intraligamentary stabilization: cadaveric study on a novel anterior cruciate ligament repair technique.

PubMed

Schliemann, Benedikt; Lenschow, Simon; Domnick, Christoph; Herbort, Mirco; Häberli, Janosch; Schulze, Martin; Wähnert, Dirk; Raschke, Michael J; Kösters, Clemens

2017-04-01

Dynamic intraligamentary stabilization (DIS) has been introduced for the repair of acute anterior cruciate ligament (ACL) tears as an alternative to delayed reconstruction. The aim of the present study was to compare knee joint kinematics after DIS to those of the ACL-intact and ACL-deficient knee under simulated Lachman/KT-1000 and pivot-shift tests. We hypothesized that DIS provides knee joint kinematics equivalent to an intact ACL. With the use of a robotic knee simulator, knee kinematics were determined in simulated Lachman/KT-1000 and pivot-shift tests at 0°, 15°, 30°, 60°, and 90° of flexion in eight cadaveric knees under the following conditions: (1) intact ACL, (2) ACL deficiency, (3) DIS with a preload of 60 N, and (4) DIS with a preload of 80 N. Statistical analyses were performed using two-factor repeated-measures analysis of variance. The significance level was set at a p value of <0.05. After DIS with a preload of either 60 N or 80 N, the anterior translation was significantly reduced in the simulated Lachman/KT-1000 and pivot-shift tests when compared to the ACL-deficient knee (p < 0.05). No significant differences were observed between the DIS reconstruction with a preload of 80 N and the intact ACL with regard to anterior laxity in either test. However, DIS with a preload of only 60 N was not able to restore knee joint kinematics to that of an intact knee in all degrees of flexion. DIS with a preload of 80 N restores knee joint kinematics comparable to that of an ACL-intact knee and is therefore capable of providing knee joint stability during ACL healing. DIS therefore provides a new technique for primary ACL repair with superior biomechanical properties in comparison with other techniques that have been described previously, although further clinical studies are required to determine its usefulness in clinical settings.

Investigation of aeroelastic stability phenomena of a helicopter by in-flight shake test

NASA Technical Reports Server (NTRS)

Miao, W. L.; Edwards, T.; Brandt, D. E.

1976-01-01

The analytical capability of the helicopter stability program is discussed. The parameters which are found to be critical to the air resonance characteristics of the soft in-plane hingeless rotor systems are detailed. A summary of two model test programs, a 1/13.8 Froude-scaled BO-105 model and a 1.67 meter (5.5 foot) diameter Froude-scaled YUH-61A model, are presented with emphasis on the selection of the final parameters which were incorporated in the full scale YUH-61A helicopter. Model test data for this configuration are shown. The actual test results of the YUH-61A air resonance in-flight shake test stability are presented. Included are a concise description of the test setup, which employs the Grumman Automated Telemetry System (ATS), the test technique for recording in-flight stability, and the test procedure used to demonstrate favorable stability characteristics with no in-plane damping augmentation (lag damper removed). The data illustrating the stability trend of air resonance with forward speed and the stability trend of ground resonance for percent airborne are presented.

WIDE RANGE ACHIEVEMENT TEST IN AUTISM SPECTRUM DISORDER: TEST-RETEST STABILITY.

PubMed

Jantz, Paul B; Bigler, Erin D; Froehlich, Alyson L; Prigge, Molly B D; Cariello, Annahir N; Travers, Brittany G; Anderson, Jeffrey; Zielinski, Brandon A; Alexander, Andrew L; Lange, Nicholas; Lainhart, Janet E

2015-06-01

The principal goal of this descriptive study was to establish the test-retest stability of the Reading, Spelling, and Arithmetic subtest scores of the Wide Range Achievement Test (WRAT-3) across two administrations in individuals with autism spectrum disorder. Participants (N = 31) were males ages 6-22 years (M = 15.2, SD = 4.0) who were part of a larger ongoing longitudinal study of brain development in children and adults with autism spectrum disorder (N = 185). Test-retest stability for all three subtests remained consistent across administration periods (M = 31.8 mo., SD = 4.1). Age at time of administration, time between administrations, and test form did not significantly influence test-retest stability. Results indicated that for research involving individuals with autism spectrum disorder with a full scale intelligence quotient above 75, the WRAT-3 Spelling and Arithmetic subtests have acceptable test-retest stability over time and the Reading subtest has moderate test-retest stability over time.

Surgical stabilization of shoulder luxation in a pot-bellied pig.

PubMed

Rubio-Martínez, Luis M; Rioja, Eva; Shakespeare, A S

2013-03-15

Case Description-A 4.6-month-old pot-bellied pig was evaluated because of non-weight-bearing lameness (grade 5/5) in the right forelimb of 4 days' duration. Clinical Findings-Clinical and radiographic examination revealed a closed, lateral luxation of the right shoulder joint. Treatment and Outcome-Initial attempts at closed reduction failed to provide adequate stability of the shoulder joint. Open reduction and internal fixation by placement of 2 lateral tension sutures with a system designed for canine cranial cruciate ligament repair provided adequate joint stability and a successful outcome. Conclusions and Clinical Relevance-Stabilization of the shoulder joint with lateral tension sutures after open reduction should be considered for management of lateral shoulder luxation in pot-bellied pigs.

16 CFR 1203.15 - Positional stability test (roll-off resistance).

Code of Federal Regulations, 2014 CFR

2014-01-01

... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Positional stability test (roll-off... SAFETY ACT REGULATIONS SAFETY STANDARD FOR BICYCLE HELMETS The Standard § 1203.15 Positional stability test (roll-off resistance). (a) Test equipment. (1) Headforms. The test headforms shall comply with the...

16 CFR 1203.15 - Positional stability test (roll-off resistance).

Code of Federal Regulations, 2011 CFR

2011-01-01

... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Positional stability test (roll-off... SAFETY ACT REGULATIONS SAFETY STANDARD FOR BICYCLE HELMETS The Standard § 1203.15 Positional stability test (roll-off resistance). (a) Test equipment. (1) Headforms. The test headforms shall comply with the...

16 CFR 1203.15 - Positional stability test (roll-off resistance).

Code of Federal Regulations, 2012 CFR

2012-01-01

... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Positional stability test (roll-off... SAFETY ACT REGULATIONS SAFETY STANDARD FOR BICYCLE HELMETS The Standard § 1203.15 Positional stability test (roll-off resistance). (a) Test equipment. (1) Headforms. The test headforms shall comply with the...

Increased torsional stability by a novel femoral neck locking plate. The role of plate design and pin configuration in a synthetic bone block model.

PubMed

Brattgjerd, Jan Egil; Loferer, Martin; Niratisairak, Sanyalak; Steen, Harald; Strømsøe, Knut

2018-06-01

In undisplaced femoral neck fractures, internal fixation remains the main treatment, with mechanical failure as a frequent complication. As torsional stable fixation promotes femoral neck fracture healing, the Hansson Pinloc® System with a plate interlocking pins, was developed from the original hook pins. Since its effect on torsional stability is undocumented, the novel implant was compared with the original configurations. Forty-two proximal femur models custom made of two blocks of polyurethane foam were tested. The medial block simulated the cancellous head, while the lateral was laminated with a glass fiber filled epoxy sheet simulating trochanteric cortical bone. Two hollow metal cylinders with a circumferential ball bearing in between mimicked the neck, with a perpendicular fracture in the middle. Fractures were fixated by two or three independent pins or by five configurations involving the interlocking plate (two pins with an optional peg in a small plate, or three pins in a small, medium or large plate). Six torsional tests were performed on each configuration to calculate torsional stiffness, torque at failure and failure energy. The novel configurations improved parameters up to an average of 12.0 (stiffness), 19.3 (torque) and 19.9 (energy) times higher than the original two pins (P < 0.001). The plate, its size and its triangular configuration improved all parameters (P = 0.03), the plate being most effective, also preventing permanent failure (P < 0.001). The novel plate design with its pin configuration enhanced torsional stability. To reveal clinical relevance a clinical study is planned. Copyright © 2018 Elsevier Ltd. All rights reserved.

Full-field measurement of micromotion around a cementless femoral stem using micro-CT imaging and radiopaque markers.

PubMed

Malfroy Camine, V; Rüdiger, H A; Pioletti, D P; Terrier, A

2016-12-08

A good primary stability of cementless femoral stems is essential for the long-term success of total hip arthroplasty. Experimental measurement of implant micromotion with linear variable differential transformers is commonly used to assess implant primary stability in pre-clinical testing. But these measurements are often limited to a few distinct points at the interface. New techniques based on micro-computed tomography (micro-CT) have recently been introduced, such as Digital Volume Correlation (DVC) or markers-based approaches. DVC is however limited to measurement around non-metallic implants due to metal-induced imaging artifacts, and markers-based techniques are confined to a small portion of the implant. In this paper, we present a technique based on micro-CT imaging and radiopaque markers to provide the first full-field micromotion measurement at the entire bone-implant interface of a cementless femoral stem implanted in a cadaveric femur. Micromotion was measured during compression and torsion. Over 300 simultaneous measurement points were obtained. Micromotion amplitude ranged from 0 to 24µm in compression and from 0 to 49µm in torsion. Peak micromotion was distal in compression and proximal in torsion. The technique bias was 5.1µm and its repeatability standard deviation was 4µm. The method was thus highly reliable and compared well with results obtained with linear variable differential transformers (LVDTs) reported in the literature. These results indicate that this micro-CT based technique is perfectly relevant to observe local variations in primary stability around metallic implants. Possible applications include pre-clinical testing of implants and validation of patient-specific models for pre-operative planning. Copyright © 2016 Elsevier Ltd. All rights reserved.

Solubilization and Stability of Mitomycin C Solutions Prepared for Intravesical Administration.

PubMed

Myers, Alan L; Zhang, Yan-Ping; Kawedia, Jitesh D; Zhou, Ximin; Sobocinski, Stacey M; Metcalfe, Michael J; Kramer, Mark A; Dinney, Colin P N; Kamat, Ashish M

2017-06-01

Mitomycin C (MMC) is an antitumor agent that is often administered intravesically to treat bladder cancer. Pharmacologically optimized studies have suggested varying methods to optimize delivery, with drug concentration and solution volume being the main drivers. However, these MMC concentrations (e.g. 2.0 mg/mL) supersede its solubility threshold, raising major concerns of inferior drug delivery. In this study, we seek to confirm that the pharmacologically optimized MMC concentrations are achievable in clinical practice through careful modifications of the solution preparation methods. MMC admixtures (1.0 and 2.0 mg/mL) were prepared in normal saline using conventional and alternative compounding methods. Conventional methodology resulted in poorly soluble solutions, with many visible particulates and crystallates. However, special compounding methods, which included incubation of solutions at 50 °C for 50 min followed by storage at 37 °C, were sufficient to solubilize drug. Chemical degradation of MMC solutions was determined over 6 h using high-performance liquid chromatography (HPLC) analytics, while physical stability was tested in parallel. Immediately following the 50 min incubation, both MMC solutions exhibited approximately 5-7% drug degradation. Based on the measured concentrations and linear regression of degradation plots, additional storage of these solutions at 37 °C for 5 h retained chemical stability criterion (< 10% overall drug loss). No physical changes were observed in any solutions at any test time points. We recommend that the described alternative preparation methods may improve intravesicular delivery of MMC in this urological setting, and advise that clinicians employing these changes should closely monitor patients for MMC toxicities and pharmacodynamics (change in clinical outcomes) that result from the potential enhancement of MMC exposure in the bladder.

Evaluation of the BD Vacutainer(®) RST blood collection tube for routine chemistry analytes: clinical significance of differences and stability study.

PubMed

Kocijancic, Marija; Cargonja, Jelena; Delic-Knezevic, Alma

2014-01-01

Preanalytical variables account for most of laboratory errors. There is a wide range of factors that affect the reliability of laboratory report. Most convenient sample type for routine laboratory analysis is serum. BD Vacutainer(®) Rapid Serum Tube (RST) (Becton, Dickinson and Company, Franklin Lakes, NJ, USA) blood collection tube provides rapid clotting time allowing fast serum separation. Our aim was to evaluate the comparability of routine chemistry parameters in BD Vacutainer(®) RST blood collection tube in reference with the BD Vacutainer(®) Serum Separating Tubes II Advance Tube (SST) (Becton, Dickinson and Company, Franklin Lakes, NJ, USA). Blood specimens were collected from 90 participants for evaluation on its results, clotting time and stability study of six routine biochemistry parameters: glucose (Glu), aspartate aminotransferase (AST), alanine aminotransferase (ALT), calcium (Ca), lactate dehidrogenase (LD) and potassium (K) measured with Olympus AU2700 analyzer (Beckman Coulter, Tokyo, Japan). The significance of the differences between samples was assessed by paired t-test or Wilcoxon Matched-Pairs Rank test after checking for normality. Clotting process was significantly shorter in the RSTs compared to SSTs (2.49 min vs. 19.47 min, respectively; P < 0.001). There was a statistically significant difference between the RST and SST II tubes for glucose, calcium and LD (P < 0.001). Differences for glucose and LD were also clinically significant. Analyte stability studies showed that all analytes were stable for 24 h at 4 °C. Most results (except LD and glucose) from RST are comparable with those from SST. In addition, RST tube provides shorter clotting time.

Fully Implantable Deep Brain Stimulation System with Wireless Power Transmission for Long-term Use in Rodent Models of Parkinson's Disease.

PubMed

Heo, Man Seung; Moon, Hyun Seok; Kim, Hee Chan; Park, Hyung Woo; Lim, Young Hoon; Paek, Sun Ha

2015-03-01

The purpose of this study to develop new deep-brain stimulation system for long-term use in animals, in order to develop a variety of neural prostheses. Our system has two distinguished features, which are the fully implanted system having wearable wireless power transfer and ability to change the parameter of stimulus parameter. It is useful for obtaining a variety of data from a long-term experiment. To validate our system, we performed pre-clinical test in Parkinson's disease-rat models for 4 weeks. Through the in vivo test, we observed the possibility of not only long-term implantation and stability, but also free movement of animals. We confirmed that the electrical stimulation neither caused any side effect nor damaged the electrodes. We proved possibility of our system to conduct the long-term pre-clinical test in variety of parameter, which is available for development of neural prostheses.

The Incidence of Adjacent Segment Degeneration after the Use of a Versatile Dynamic Hybrid Stabilization Device in Lumbar Stenosis: Results of a 5–8-Year Follow-up

PubMed Central

Dobran, Mauro; Esposito, Domenico Paolo; Gladi, Maurizio; Scerrati, Massimo; Iacoangeli, Maurizio

2018-01-01

Study Design Retrospective study with long-term follow-up. Purpose To evaluate the long-term incidence of adjacent segment degeneration (ASD) and clinical outcomes in a consecutive series of patients who underwent spinal decompression associated with dynamic or hybrid stabilization with a Flex+TM stabilization system (SpineVision, Antony, France) for lumbar spinal stenosis. Overview of Literature The incidence of ASD and clinical outcomes following dynamic or hybrid stabilization with the Flex+TM system used for lumbar spinal stenosis have not been well investigated. Methods Twenty-one patients with lumbar stenosis and probable post-decompressive spinal instability underwent decompressive laminectomy followed by spinal stabilization using the Flex+TM stabilization system. The indication for a mono-level dynamic stabilization was a preoperative magnetic resonance imaging (MRI) demonstrating evidence of severe disc disease associated with severe spinal stenosis. The hybrid stabilization (rigid-dynamic) system was used for multilevel laminectomies with associated initial degenerative scoliosis, first-grade spondylolisthesis, or rostral pathology. Results The improvement in Visual Analog Scale and Oswestry Disability Index scores at follow-up were statistically significant (p<0.0001 and p<0.0001, respectively). At the 5–8-year follow-up, clinical examination, MRI, and X-ray findings showed an ASD complication with pain and disability in one of 21 patients. The clinical outcomes were similar in patients treated with dynamic or hybrid fixation. Conclusions Patients treated with laminectomy and Flex+TM stabilization presented a satisfactory clinical outcome after 5–8 years of follow-up, and ASD incidence in our series was 4.76% (one patient out of 21). We are aware that this is a small series, but our long-term follow-up may be sufficient to contribute to the expanding body of literature on the development of symptomatic ASD associated with dynamic or hybrid fixation. PMID:29713407

Large-scale manufacturing of GMP-compliant anti-EGFR targeted nanocarriers: production of doxorubicin-loaded anti-EGFR-immunoliposomes for a first-in-man clinical trial.

PubMed

Wicki, Andreas; Ritschard, Reto; Loesch, Uli; Deuster, Stefanie; Rochlitz, Christoph; Mamot, Christoph

2015-04-30

We describe the large-scale, GMP-compliant production process of doxorubicin-loaded and anti-EGFR-coated immunoliposomes (anti-EGFR-ILs-dox) used in a first-in-man, dose escalation clinical trial. 10 batches of this nanoparticle have been produced in clean room facilities. Stability data from the pre-GMP and the GMP batch indicate that the anti-EGFR-ILs-dox nanoparticle was stable for at least 18 months after release. Release criteria included visual inspection, sterility testing, as well as measurements of pH (pH 5.0-7.0), doxorubicin HCl concentration (0.45-0.55 mg/ml), endotoxin concentration (<1.21 IU/ml), leakage (<10%), particle size (Z-average of Caelyx ± 20 nm), and particle uptake (uptake absolute: >0.50 ng doxorubicin/μg protein; uptake relatively to PLD: >5 fold). All batches fulfilled the defined release criteria, indicating a high reproducibility as well as batch-to-batch uniformity of the main physico-chemical features of the nanoparticles in the setting of the large-scale GMP process. In the clinical trial, 29 patients were treated with this nanoparticle between 2007 and 2010. Pharmacokinetic data of anti-EGFR-ILs-dox collected during the clinical study revealed stability of the nanocarrier in vivo. Thus, reliable and GMP-compliant production of anti-EGFR-targeted nanoparticles for clinical application is feasible. Copyright © 2015 Elsevier B.V. All rights reserved.

Immediate versus delayed loading of strategic mini dental implants for the stabilization of partial removable dental prostheses: a patient cluster randomized, parallel-group 3-year trial.

PubMed

Mundt, Torsten; Al Jaghsi, Ahmad; Schwahn, Bernd; Hilgert, Janina; Lucas, Christian; Biffar, Reiner; Schwahn, Christian; Heinemann, Friedhelm

2016-07-30

Acceptable short-term survival rates (>90 %) of mini-implants (diameter < 3.0 mm) are only documented for mandibular overdentures. Sound data for mini-implants as strategic abutments for a better retention of partial removable dental prosthesis (PRDP) are not available. The purpose of this study is to test the hypothesis that immediately loaded mini-implants show more bone loss and less success than strategic mini-implants with delayed loading. In this four-center (one university hospital, three dental practices in Germany), parallel-group, controlled clinical trial, which is cluster randomized on patient level, a total of 80 partially edentulous patients with unfavourable number and distribution of remaining abutment teeth in at least one jaw will receive supplementary min-implants to stabilize their PRDP. The mini-implant are either immediately loaded after implant placement (test group) or delayed after four months (control group). Follow-up of the patients will be performed for 36 months. The primary outcome is the radiographic bone level changes at implants. The secondary outcome is the implant success as a composite variable. Tertiary outcomes include clinical, subjective (quality of life, satisfaction, chewing ability) and dental or technical complications. Strategic implants under an existing PRDP are only documented for standard-diameter implants. Mini-implants could be a minimal invasive and low cost solution for this treatment modality. The trial is registered at Deutsches Register Klinischer Studien (German register of clinical trials) under DRKS-ID: DRKS00007589 ( www.germanctr.de ) on January 13(th), 2015.

Long-term stability of CMV DNA in human breast milk.

PubMed

Sam, Soya S; Ingersoll, Jessica; Racsa, Lori D; Caliendo, Angela M; Racsa, Patrick N; Igwe, Doris; Abdul-Ali, Deborah; Josephson, Cassandra; Kraft, Colleen S

2018-05-01

Human cytomegalovirus (CMV) is the leading cause of intrauterine and perinatal viral infection. The most common route of CMV transmission in newborns is through breastmilk and this can lead to infant morbidity and mortality. Breast milk that has been frozen for an extended period may need to be tested for CMV DNA to determine the source of infection. It has been a challenge for clinical laboratories to ensure the stability of CMV DNA in frozen breast milk for accurate viral load measurement. To evaluate the stability of CMV DNA in breast milk by testing quantitative viral loads over a 28-day period for breast milk stored at 4 °C and a 90-day period for breast milk stored at -20 °C. Baseline viral loads were determined on day 0 and the samples stored at 4 °C underwent extraction and amplification at four time points, up to 28 days. The samples stored at -20 °C underwent extraction and amplification at five time points up to 90 days. Log 10 values were calculated and t-test, Pearson's coefficient, and concordance correlation coefficient were calculated. There was no statistically significant difference between the time points by t-test, and correlation coefficients showed greater than 90% concordance for days 0 and 28 as well as days 0 and 90 at both storage temperatures tested. The concentration of CMV DNA in breast milk was stable for 28 days at 4 °C and 90 days at -20 °C as the concentrations did not differ significantly from the baseline viral loads. Copyright © 2018 Elsevier B.V. All rights reserved.

46 CFR 178.320 - Intact stability requirements-non-sailing vessels.

Code of Federal Regulations, 2012 CFR

2012-10-01

... following vessels may undergo the simplified stability proof test detailed in § 178.330 of this part, in the... this part, a self-propelled pontoon vessel may undergo the pontoon simplified stability proof test... deck cargo, and is otherwise eligible to undergo the simplified stability proof test detailed in § 178...

46 CFR 178.320 - Intact stability requirements-non-sailing vessels.

Code of Federal Regulations, 2014 CFR

2014-10-01

... following vessels may undergo the simplified stability proof test detailed in § 178.330 of this part, in the... this part, a self-propelled pontoon vessel may undergo the pontoon simplified stability proof test... deck cargo, and is otherwise eligible to undergo the simplified stability proof test detailed in § 178...

46 CFR 178.320 - Intact stability requirements-non-sailing vessels.

Code of Federal Regulations, 2013 CFR

2013-10-01

... following vessels may undergo the simplified stability proof test detailed in § 178.330 of this part, in the... this part, a self-propelled pontoon vessel may undergo the pontoon simplified stability proof test... deck cargo, and is otherwise eligible to undergo the simplified stability proof test detailed in § 178...

46 CFR 178.320 - Intact stability requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... stability proof test in accordance with § 178.330 of this part in the presence of a Coast Guard marine inspector. (b) A pontoon vessel operating on protected waters must undergo a simplified stability proof test... cognizant OCMI may dispense with the simplified stability proof test in § 178.330 for a vessel carrying not...

LOX/Hydrocarbon Combustion Instability Investigation

NASA Technical Reports Server (NTRS)

Jensen, R. J.; Dodson, H. C.; Claflin, S. E.

1989-01-01

The LOX/Hydrocarbon Combustion Instability Investigation Program was structured to determine if the use of light hydrocarbon combustion fuels with liquid oxygen (LOX) produces combustion performance and stability behavior similar to the LOX/hydrogen propellant combination. In particular methane was investigated to determine if that fuel can be rated for combustion instability using the same techniques as previously used for LOX/hydrogen. These techniques included fuel temperature ramping and stability bomb tests. The hot fire program probed the combustion behavior of methane from ambient to subambient temperatures. Very interesting results were obtained from this program that have potential importance to future LOX/methane development programs. A very thorough and carefully reasoned documentation of the experimental data obtained is contained. The hot fire test logic and the associated tests are discussed. Subscale performance and stability rating testing was accomplished using 40,000 lb. thrust class hardware. Stability rating tests used both bombs and fuel temperature ramping techniques. The test program was successful in generating data for the evaluation of the methane stability characteristics relative to hydrogen and to anchor stability models. Data correlations, performance analysis, stability analyses, and key stability margin enhancement parameters are discussed.

A Physics-Based Temperature Stabilization Criterion for Thermal Testing

NASA Technical Reports Server (NTRS)

Rickman, Steven L.; Ungar, Eugene K.

2009-01-01

Spacecraft testing specifications differ greatly in the criteria they specify for stability in thermal balance tests. Some specify a required temperature stabilization rate (the change in temperature per unit time, dT/dt), some specify that the final steady-state temperature be approached to within a specified difference, delta T , and some specify a combination of the two. The particular values for temperature stabilization rate and final temperature difference also vary greatly between specification documents. A one-size-fits-all temperature stabilization rate requirement does not yield consistent results for all test configurations because of differences in thermal mass and heat transfer to the environment. Applying a steady-state temperature difference requirement is problematic because the final test temperature is not accurately known a priori, especially for powered configurations. In the present work, a simplified, lumped-mass analysis has been used to explore the applicability of these criteria. A new, user-friendly, physics-based approach is developed that allows the thermal engineer to determine when an acceptable level of temperature stabilization has been achieved. The stabilization criterion can be predicted pre-test but must be refined during test to allow verification that the defined level of temperature stabilization has been achieved.

A clinical study to evaluate denture adhesive use in well-fitting dentures.

PubMed

Munoz, Carlos A; Gendreau, Linda; Shanga, Gilbert; Magnuszewski, Tabetha; Fernandez, Patricia; Durocher, John

2012-02-01

The objective of this study was the assessment of retention and stability and functional benefits of denture adhesive applied to well-fitting and well-made dentures. This was a randomized, crossover study to compare two marketed denture adhesives (test cream, Super Poligrip® Free, and test strip, Super Poligrip® Comfort Seal Strips) and an unmarketed cream adhesive (GlaxoSmith Kline Consumer Healthcare) with no adhesive as the negative control. Thirty-six subjects completed the study. One hour after the application of denture adhesive, retention and stability were measured using the Kapur Index and maxillary incisal bite force. Two hours after application, functional tests were used to assess denture movement and peanut particle migration under the denture. Subjects also rated confidence, comfort, satisfaction with dentures, and denture wobble in conjunction with the functional tests. Denture adhesives significantly (p < 0.05) improved retention and stability of well-fitting dentures. Subjects experienced significantly (p < 0.05) fewer dislodgements while eating an apple after adhesive was applied to dentures. Significant (p < 0.05) increases in subjective ratings of confidence and comfort as well as decreases in denture wobble were associated with the use of adhesive. There was significant (p < 0.05) improvement in satisfaction ratings for cream adhesives. A single application of each denture adhesive was well tolerated. The results of this study provide evidence that use of Super Poligrip® denture adhesives can enhance aspects of performance of complete well-fitting dentures as well as provide increased comfort, confidence, and satisfaction with dentures. © 2011 by the American College of Prosthodontists.

[Aseptic process validation and stability study of an injectable preparation of fructose (5%)-glycerol (10%) as part of a hospital clinical research program on endoscopic curative treatment for early epithelial neoplastic lesions of the gastrointestinal tract].

PubMed

Tall, M L; Salmon, D; Diouf, E; Drai, J; Filali, S; Lépilliez, V; Pioche, M; Laleye, D; Dhelens, C; Ponchon, T; Pivot, C; Pirot, F

2015-03-01

As part of a hospital clinical research program on endoscopic curative treatment for early epithelial neoplastic lesions of the gastrointestinal tract, a new hospital sterile and non-pyrogenic preparation of fructose (5%)-glycerol (10%) was realized. Under pharmaceutical legislation, the provision of this hospital preparation involves of aseptic process validation and achieve a stability study. After the aseptic process validation with Mediafill Test, the preparation was made under aseptic conditions associated with a sterilizing filtration according to the good practices preparation. Prepared flexible bags (100mL of solution) were stored for one year in a climatic chamber (25±2°C). To assess stability, the physicochemical controls (fructose concentration, glycerol concentration, hydroxy-methyl-5 furfural [5-HMF] concentration, sodium concentration, pH measure, osmolality and sub-visible particles count) and microbiological (bioburden, bacterial endotoxin and sterility) were performed at regular intervals for one year. Neither significant decrease of fructose concentration, glycerol concentration and sodium concentration nor pH, 5-HMF, osmolality variations out of specifications were observed for one year. The sub-visible particles count, the bacterial endotoxin and sterility were in accordance with the European pharmacopoeia attesting limpidity, apyrogenicity and sterility of this injectable preparation. The hospital preparation was stable over one year at 25±2°C, ensuring safe administration in humans within the framework of this clinical research. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

Curcumin-loaded self-nanomicellizing solid dispersion system: part I: development, optimization, characterization, and oral bioavailability.

PubMed

Parikh, Ankit; Kathawala, Krishna; Song, Yunmei; Zhou, Xin-Fu; Garg, Sanjay

2018-05-29

Curcumin (CUR) is considered as one of the most bioactive molecules ever discovered from nature due to its proven anti-inflammatory and antioxidant in both preclinical and clinical studies. Despite its proven safety and efficacy, the clinical translation of CUR into a useful therapeutic agent is still limited due to its poor oral bioavailability. To overcome its limitation and enhance oral bioavailability by improving its aqueous solubility, stability, and intestinal permeability, a novel CUR formulation (NCF) was developed using the self-nanomicellizing solid dispersion strategy. From the initial screening of polymers for their potential to improve the solubility and stability, Soluplus (SOL) was selected. The optimized NCF demonstrated over 20,000-fold improvement in aqueous solubility as a result of amorphization, hydrogen bonding interaction, and micellization determined using differential scanning calorimetry, X-ray diffraction, scanning electron microscopy, Fourier transform infrared spectroscopy, nuclear magnetic resonance, dynamic light scattering, and transmission electron microscopy. Moreover, the greater stabilizing effect in alkaline pH and light was observed. Furthermore, significant enhancement of dissolution and permeability of CUR across everted sacs of rat small intestine were noticed. Pharmacokinetic studies demonstrated that the oral bioavailability of CUR was increased 117 and 17-fold in case of NCF and physical mixture of CUR and SOL compared to CUR suspension. These results suggest NCF identified as a promising new approach for repositioning of CUR for pharmaceutical application by enhancing the oral bioavailability of CUR. The findings herein stimulate further in vivo evaluations and clinical tests of NCF.

Advances in neglected tropical disease vaccines: Developing relative potency and functional assays for the Na-GST-1/Alhydrogel hookworm vaccine

PubMed Central

Brelsford, Jill B.; Plieskatt, Jordan L.; Yakovleva, Anna; Jariwala, Amar; Keegan, Brian P.; Peng, Jin; Xia, Pengjun; Li, Guangzhao; Campbell, Doreen; Periago, Maria Victoria; Correa-Oliveira, Rodrigo; Bottazzi, Maria Elena; Hotez, Peter J.

2017-01-01

A new generation of vaccines for the neglected tropical diseases (NTDs) have now advanced into clinical development, with the Na-GST-1/Alhydrogel Hookworm Vaccine already being tested in Phase 1 studies in healthy adults. The current manuscript focuses on the often overlooked critical aspects of NTD vaccine product development, more specifically, vaccine stability testing programs. A key measure of vaccine stability testing is "relative potency" or the immunogenicity of the vaccine during storage. As with most NTD vaccines, the Na-GST-1/Alhydrogel Hookworm Vaccine was not developed by attenuation or inactivation of the pathogen (Necator americanus), so conventional methods for measuring relative potency are not relevant for this investigational product. Herein, we describe a novel relative potency testing program and report for the first time on the clinical lot of this NTD vaccine during its first 60 months of storage at 2–8°C. We also describe the development of a complementary functional assay that measures the ability of IgG from animals or humans immunized with Na-GST-1/Alhydrogel to neutralize this important hookworm enzyme. While 90% inhibition of the catalytic activity of Na-GST-1 was achieved in animals immunized with Na-GST-1/Alhydrogel, lower levels of inhibition were observed in immunized humans. Moreover, anti-Na-GST-1 antibodies from volunteers in non-hookworm endemic areas were better able to inhibit catalytic activity than anti-Na-GST-1 antibodies from volunteers resident in hookworm endemic areas. The results described herein provide the critical tools for the product development of NTD vaccines. PMID:28192438

Evaluations of UltraiQ software for objective ultrasound image quality assessment using images from a commercial scanner.

PubMed

Long, Zaiyang; Tradup, Donald J; Stekel, Scott F; Gorny, Krzysztof R; Hangiandreou, Nicholas J

2018-03-01

We evaluated a commercially available software package that uses B-mode images to semi-automatically measure quantitative metrics of ultrasound image quality, such as contrast response, depth of penetration (DOP), and spatial resolution (lateral, axial, and elevational). Since measurement of elevational resolution is not a part of the software package, we achieved it by acquiring phantom images with transducers tilted at 45 degrees relative to the phantom. Each measurement was assessed in terms of measurement stability, sensitivity, repeatability, and semi-automated measurement success rate. All assessments were performed on a GE Logiq E9 ultrasound system with linear (9L or 11L), curved (C1-5), and sector (S1-5) transducers, using a CIRS model 040GSE phantom. In stability tests, the measurements of contrast, DOP, and spatial resolution remained within a ±10% variation threshold in 90%, 100%, and 69% of cases, respectively. In sensitivity tests, contrast, DOP, and spatial resolution measurements followed the expected behavior in 100%, 100%, and 72% of cases, respectively. In repeatability testing, intra- and inter-individual coefficients of variations were equal to or less than 3.2%, 1.3%, and 4.4% for contrast, DOP, and spatial resolution (lateral and axial), respectively. The coefficients of variation corresponding to the elevational resolution test were all within 9.5%. Overall, in our assessment, the evaluated package performed well for objective and quantitative assessment of the above-mentioned image qualities under well-controlled acquisition conditions. We are finding it to be useful for various clinical ultrasound applications including performance comparison between scanners from different vendors. © 2018 The Authors. Journal of Applied Clinical Medical Physics published by Wiley Periodicals, Inc. on behalf of American Association of Physicists in Medicine.

Validation of the French version of the Burn Specific Health Scale-Brief (BSHS-B) questionnaire.

PubMed

Gandolfi, S; Auquit-Auckbur, I; Panunzi, S; Mici, E; Grolleau, J-L; Chaput, B

2016-11-01

The Burn Specific Health Scale-Brief questionnaire is a widely validated tool for estimating the health related quality of life and for assessing the best multidisciplinary management of burn patients. The aim of this study was to translate the BSHS-B into French and to investigate its reliability and validity. According to the procedure proposed by the Scientific Advisory Committee of the Medical Outcomes Trust, the Burn Specific Health Scale-Brief (BSHS-B) was translated from the English version into French. In order to test the reliability of the French version of the BSHS-B, 53 burn patients French speakers completed the BSHS-B and SF-36 questionnaires from two to four years after burn. Ten of them have been re-tested at 6 months after the first evaluation. To evaluate clinical utility of the BSHS-F, internal consistency, construct validity (using SF-36) and stability in time were assessed using Cronbach's alpha statistic, Spearman rank test, and intra-class correlation coefficient respectively. The French version of the BSHS-B Cronbach's alpha coefficient was 0.93 and was >0.80 for all the sub-domains. French version of the BSHS-B and the SF-36 were positively correlated, all the associations were statistically significant (p<0.01). Intra-class correlation coefficients for test-retest ranged between 0.95 and 0.99 for the sub-domains. The intra-class correlation coefficient (ICC) for the total score was 0.98. The French version of the BSHS-B shows a robust rate of internal consistency, construct validity and stability in time, supporting its application in routine clinical practice as well as in international studies. Copyright © 2016 Elsevier Ltd and ISBI. All rights reserved.

Cost-effectiveness of point-of-care testing for dehydration in the pediatric ED.

PubMed

Whitney, Rachel E; Santucci, Karen; Hsiao, Allen; Chen, Lei

2016-08-01

Acute gastroenteritis (AGE) and subsequent dehydration account for a large proportion of pediatric emergency department (PED) visits. Point-of-care (POC) testing has been used in conjunction with clinical assessment to determine the degree of dehydration. Despite the wide acceptance of POC testing, little formal cost-effective analysis of POC testing in the PED exists. We aim to examine the cost-effectiveness of using POC electrolyte testing vs traditional serum chemistry testing in the PED for children with AGE. This was a cost-effective analysis using data from a randomized control trial of children with AGE. A decision analysis model was constructed to calculate cost-savings from the point of view of the payer and the provider. We used parameters obtained from the trial, including cost of testing, admission rates, cost of admission, and length of stay. Sensitivity analyses were performed to evaluate the stability of our model. Using the data set of 225 subjects, POC testing results in a cost savings of $303.30 per patient compared with traditional serum testing from the point of the view of the payer. From the point-of-view of the provider, POC testing results in consistent mean savings of $36.32 ($8.29-$64.35) per patient. Sensitivity analyses demonstrated the stability of the model and consistent savings. This decision analysis provides evidence that POC testing in children with gastroenteritis-related moderate dehydration results in significant cost savings from the points of view of payers and providers compared to traditional serum chemistry testing. Copyright © 2016 Elsevier Inc. All rights reserved.

Rapid Stabilization/Polymerization of Wet Clay Soils; Literature Review

DTIC Science & Technology

2009-01-15

known as lime, and potassium hydroxide (KOH) were found to increase shear strength, and decrease expansive properties of Diablo clay. The lime...Publication Date: 1991 Purpose of Stabilizer: Control High Swell Potential Stabilizers Tested: Lime, potassium phosphate, potassium chloride...Date: 1988 Purpose of Stabilizer: Stabilizer Stabilizers Tested: Hydroxy-aluminum, hydroxy-aluminum and potassium chloride, hydroxy-aluminum

Postural Stability in Healthy Child and Youth Athletes: The Effect of Age, Sex, and Concussion-Related Factors on Performance.

PubMed

Paniccia, Melissa; Wilson, Katherine E; Hunt, Anne; Keightley, Michelle; Zabjek, Karl; Taha, Tim; Gagnon, Isabelle; Reed, Nick

Postural stability plays a key role in sport performance, especially after concussion. Specific to healthy child and youth athletes, little is known about the influence development and sex may have on postural stability while considering other subjective clinical measures used in baseline/preinjury concussion assessment. This study aims to describe age- and sex-based trends in postural stability in uninjured child and youth athletes at baseline while accounting for concussion-related factors. (1) Postural stability performance will improve with age, (2) females will display better postural stability compared to males, and (3) concussion-like symptoms will affect postural stability performance in healthy children and youth. Cross-sectional study. Level 3. This study comprised 889 healthy/uninjured child and youth athletes (54% female, 46% male) between the ages of 9 and 18 years old. Participants completed preseason baseline testing, which included demographic information (age, sex, concussion history), self-report of concussion-like symptoms (Post-Concussion Symptom Inventory [PCSI]-Child and PCSI-Youth), and measures of postural stability (BioSway; Biodex Medical Systems). Two versions of the PCSI were used (PCSI-C, 9- to 12-year-olds; PCSI-Y, 13- to 18-year-olds). Postural stability was assessed via sway index under 4 sway conditions of increasing difficulty by removing visual and proprioceptive cues. In children aged 9 to 12 years old, there were significant age- ( P < 0.05) and sex-based effects ( P < 0.05) on postural stability. Performance improved with age, and girls performed better than boys. For youth ages 13 to 18 years old, postural stability also improved with age ( P < 0.05). In both child and youth subgroups, postural stability worsened with increasing concussion-like symptoms ( P < 0.05). There are developmental and baseline symptom trends regarding postural stability performance. These findings provide a preliminary foundation for postconcussion comparisons and highlight the need for a multimodal approach in assessing and understanding physical measures such as postural stability.

Clinical Evaluation of the BD FACSPresto™ Near-Patient CD4 Counter in Kenya

PubMed Central

Angira, Francis; Akoth, Benta; Omolo, Paul; Opollo, Valarie; Bornheimer, Scott; Judge, Kevin; Tilahun, Henok; Lu, Beverly; Omana-Zapata, Imelda; Zeh, Clement

2016-01-01

Background The BD FACSPresto™ Near-Patient CD4 Counter was developed to expand HIV/AIDS management in resource-limited settings. It measures absolute CD4 counts (AbsCD4), percent CD4 (%CD4), and hemoglobin (Hb) from a single drop of capillary or venous blood in approximately 23 minutes, with throughput of 10 samples per hour. We assessed the performance of the BD FACSPresto system, evaluating accuracy, stability, linearity, precision, and reference intervals using capillary and venous blood at KEMRI/CDC HIV-research laboratory, Kisumu, Kenya, and precision and linearity at BD Biosciences, California, USA. Methods For accuracy, venous samples were tested using the BD FACSCalibur™ instrument with BD Tritest™ CD3/CD4/CD45 reagent, BD Trucount™ tubes, and BD Multiset™ software for AbsCD4 and %CD4, and the Sysmex™ KX-21N for Hb. Stability studies evaluated duration of staining (18–120-minute incubation), and effects of venous blood storage <6–24 hours post-draw. A normal cohort was tested for reference intervals. Precision covered multiple days, operators, and instruments. Linearity required mixing two pools of samples, to obtain evenly spaced concentrations for AbsCD4, total lymphocytes, and Hb. Results AbsCD4 and %CD4 venous/capillary (N = 189/ N = 162) accuracy results gave Deming regression slopes within 0.97–1.03 and R2 ≥0.96. For Hb, Deming regression results were R2 ≥0.94 and slope ≥0.94 for both venous and capillary samples. Stability varied within 10% 2 hours after staining and for venous blood stored less than 24 hours. Reference intervals results showed that gender—but not age—differences were statistically significant (p<0.05). Precision results had <3.5% coefficient of variation for AbsCD4, %CD4, and Hb, except for low AbsCD4 samples (<6.8%). Linearity was 42–4,897 cells/μL for AbsCD4, 182–11,704 cells/μL for total lymphocytes, and 2–24 g/dL for Hb. Conclusions The BD FACSPresto system provides accurate, precise clinical results for capillary or venous blood samples and is suitable for near-patient CD4 testing. Trial Registration ClinicalTrials.gov NCT02396355 PMID:27483008

Chronotypes in patients with nonseasonal depressive disorder: Distribution, stability and association with clinical variables.

PubMed

Müller, Matthias Johannes; Cabanel, Nicole; Olschinski, Christiane; Jochim, Dorothee; Kundermann, Bernd

2015-01-01

The individual's chronotype is regarded as rather stable trait with substantial heritability and normal distribution of the "morningness-eveningness" dimension in the general population. Eveningness has been related to the risk of developing affective, particularly depressive, disorders. However, age and other sociobiological factors may influence chronotypes. The present study investigated the distribution, stability, and clinical correlates of chronotype and morningness-eveningness in hospitalized patients with affective disorder. Chronotype was assessed with the morningness-eveningness questionnaire (MEQ) in 93 patients with nonseasonal depressive syndrome (85% major depression; 15% depressive adjustment disorder) after admission, and in 19 patients again before discharge. Distribution, stability and correlations of MEQ scores with clinical variables were calculated. Additionally, a literature analysis of chronotype distributions in samples of nondepressed persons and patients with nonseasonal depression was carried out. MEQ scores (mean 49 ± 11, range 23-75, higher scores indicate morningness) in 93 acutely depressed inpatients (age 41 ± 14 years, range 18-75 years; 63% women; hospitalization 48 ± 22 days; BDI-II 32 ± 11) were normally distributed (Shapiro-Wilk test; W = 0.993, p = 0.920) with 59.1% intermediate types, 19.4% evening types, and 21.5% morning types. MEQ change scores from admission to discharge were nonsignificant (-1.3 ± 5.0; paired t-test, t18 = -1.09; p = 0.29) despite significantly improved depression scores (-19.4 ± 7.6; paired t-test, t18 = 11.2, p < 0.001). Age (r = 0.24), and depression scores (r = -0.21) correlated significantly (p < 0.05) with MEQ scores; associations with sex and hospitalization duration were nonsignificant. The present study and literature findings revealed that the frequency of evening types is not clearly elevated in depression, but morning types are less frequent compared to healthy samples (p < 0.001). Morningness-eveningness scores were normally distributed and stable in depressive inpatients. In line with previous findings, but contrary to theoretical assumptions, evening types were not overrepresented in depressed patients. Additionally, relatively less morning types and more intermediate types were found in depressed patients. Future studies should focus on transitions from morning to intermediate types as a tentative risk or correlate of emerging depression.

NIKE: a new clinical tool for establishing levels of indications for cataract surgery.

PubMed

Lundström, Mats; Albrecht, Susanne; Håkansson, Ingemar; Lorefors, Ragnhild; Ohlsson, Sven; Polland, Werner; Schmid, Andrea; Svensson, Göran; Wendel, Eva

2006-08-01

The purpose of this study was to construct a new clinical tool for establishing levels of indications for cataract surgery, and to validate this tool. Teams from nine eye clinics reached an agreement about the need to develop a clinical tool for setting levels of indications for cataract surgery and about the items that should be included in the tool. The tool was to be called 'NIKE' (Nationell Indikationsmodell för Kataraktextraktion). The Canadian Cataract Priority Criteria Tool served as a model for the NIKE tool, which was modified for Swedish conditions. Items included in the tool were visual acuity of both eyes, patients' perceived difficulties in day-to-day life, cataract symptoms, the ability to live independently, and medical/ophthalmic reasons for surgery. The tool was validated and tested in 343 cataract surgery patients. Validity, stability and reliability were tested and the outcome of surgery was studied in relation to the indication setting. Four indication groups (IGs) were suggested. The group with the greatest indications for surgery was named group 1 and that with the lowest, group 4. Validity was proved to be good. Surgery had the greatest impact on the group with the highest indications for surgery. Test-retest reliability test and interexaminer tests of indication settings showed statistically significant intraclass correlations (intraclass correlation coefficients [ICCs] 0.526 and 0.923, respectively). A new clinical tool for indication setting in cataract surgery is presented. This tool, the NIKE, takes into account both visual acuity and the patient's perceived problems in day-to-day life because of cataract. The tool seems to be stable and reliable and neutral towards different examiners.

33 CFR 183.330 - Stability test.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 33 Navigation and Navigable Waters 2 2012-07-01 2012-07-01 false Stability test. 183.330 Section 183.330 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED... of 2 Horsepower or Less Tests § 183.330 Stability test. (a) Flotation standard. When the conditions...

33 CFR 183.330 - Stability test.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false Stability test. 183.330 Section 183.330 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED... of 2 Horsepower or Less Tests § 183.330 Stability test. (a) Flotation standard. When the conditions...

33 CFR 183.330 - Stability test.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 33 Navigation and Navigable Waters 2 2014-07-01 2014-07-01 false Stability test. 183.330 Section 183.330 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED... of 2 Horsepower or Less Tests § 183.330 Stability test. (a) Flotation standard. When the conditions...

33 CFR 183.330 - Stability test.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 33 Navigation and Navigable Waters 2 2013-07-01 2013-07-01 false Stability test. 183.330 Section 183.330 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED... of 2 Horsepower or Less Tests § 183.330 Stability test. (a) Flotation standard. When the conditions...

33 CFR 183.230 - Stability test.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 33 Navigation and Navigable Waters 2 2014-07-01 2014-07-01 false Stability test. 183.230 Section 183.230 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED... of More Than 2 Horsepower Tests § 183.230 Stability test. (a) Flotation standard. When the conditions...

33 CFR 183.230 - Stability test.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false Stability test. 183.230 Section 183.230 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED... of More Than 2 Horsepower Tests § 183.230 Stability test. (a) Flotation standard. When the conditions...

33 CFR 183.230 - Stability test.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 33 Navigation and Navigable Waters 2 2012-07-01 2012-07-01 false Stability test. 183.230 Section 183.230 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED... of More Than 2 Horsepower Tests § 183.230 Stability test. (a) Flotation standard. When the conditions...

33 CFR 183.230 - Stability test.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 33 Navigation and Navigable Waters 2 2013-07-01 2013-07-01 false Stability test. 183.230 Section 183.230 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED... of More Than 2 Horsepower Tests § 183.230 Stability test. (a) Flotation standard. When the conditions...

33 CFR 183.230 - Stability test.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 33 Navigation and Navigable Waters 2 2011-07-01 2011-07-01 false Stability test. 183.230 Section 183.230 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED... of More Than 2 Horsepower Tests § 183.230 Stability test. (a) Flotation standard. When the conditions...

33 CFR 183.330 - Stability test.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 33 Navigation and Navigable Waters 2 2011-07-01 2011-07-01 false Stability test. 183.330 Section 183.330 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED... of 2 Horsepower or Less Tests § 183.330 Stability test. (a) Flotation standard. When the conditions...

Does core stability exercise improve lumbopelvic stability (through endurance tests) more than general exercise in chronic low back pain? A quasi-randomized controlled trial.

PubMed

Shamsi, Mohammad Bagher; Rezaei, Mandana; Zamanlou, Mehdi; Sadeghi, Mehdi; Pourahmadi, Mohammad Reza

2016-01-01

The aim was to compare core stability and general exercises (GEs) in chronic low back pain (LBP) patients based on lumbopelvic stability (LPS) assessment through three endurance core stability tests. There is a controversy about preference of core stability exercise (CSE) over other types of exercise for chronic LBP. Studies which have compared these exercises used other outcomes than those related to LPS. As it is claimed that CSE enhances back stability, endurance tests for LPS were used. A 16-session CSE program and a GE program with the same duration were conducted for two groups of participants. Frequency of interventions for both groups was three times a week. Forty-three people (aged 18-60 years) with chronic non-specific LBP were alternately allocated to core stability (n = 22) or GE group (n = 21) when admitted. The primary outcomes were three endurance core stability tests including: (1) trunk flexor; (2) trunk extensor; and (3) side bridge tests. Secondary outcomes were disability and pain. Measurements were taken at baseline and the end of the intervention. After the intervention, test times increased and disability and pain decreased within groups. There was no significant difference between two groups in increasing test times (p = 0.23 to p = 0.36) or decreasing disability (p = 0.16) and pain (p = 0.73). CSE is not more effective than GE for improving endurance core stability tests and reducing disability and pain in chronic non-specific LBP patients.

Advanced Multi-Axis Spine Testing: Clinical Relevance and Research Recommendations

PubMed Central

Holsgrove, Timothy P.; Nayak, Nikhil R.; Welch, William C.

2015-01-01

Back pain and spinal degeneration affect a large proportion of the general population. The economic burden of spinal degeneration is significant, and the treatment of spinal degeneration represents a large proportion of healthcare costs. However, spinal surgery does not always provide improved clinical outcomes compared to non-surgical alternatives, and modern interventions, such as total disc replacement, may not offer clinically relevant improvements over more established procedures. Although psychological and socioeconomic factors play an important role in the development and response to back pain, the variation in clinical success is also related to the complexity of the spine, and the multi-faceted manner by which spinal degeneration often occurs. The successful surgical treatment of degenerative spinal conditions requires collaboration between surgeons, engineers, and scientists in order to provide a multi-disciplinary approach to managing the complete condition. In this review, we provide relevant background from both the clinical and the basic research perspectives, which is synthesized into several examples and recommendations for consideration in increasing translational research between communities with the goal of providing improved knowledge and care. Current clinical imaging, and multi-axis testing machines, offer great promise for future research by combining invivo kinematics and loading with in-vitro testing in six degrees of freedom to offer more accurate predictions of the performance of new spinal instrumentation. Upon synthesis of the literature, it is recommended that in-vitro tests strive to recreate as many aspects of the in-vivo environment as possible, and that a physiological preload is a critical factor in assessing spinal biomechanics in the laboratory. A greater link between surgical procedures, and the outcomes in all three anatomical planes should be considered in both the in-vivo and in-vitro settings, to provide data relevant to quality of motion, and stability. PMID:26273552

Mass spectrometric characterization of the hypoxia-inducible factor (HIF) stabilizer drug candidate BAY 85-3934 (molidustat) and its glucuronidated metabolite BAY-348, and their implementation into routine doping controls.

PubMed

Dib, Josef; Mongongu, Cynthia; Buisson, Corinne; Molina, Adeline; Schänzer, Wilhelm; Thuss, Uwe; Thevis, Mario

2017-01-01

The development of new therapeutics potentially exhibiting performance-enhancing properties implicates the risk of their misuse by athletes in amateur and elite sports. Such drugs necessitate preventive anti-doping research for consideration in sports drug testing programmes. Hypoxia-inducible factor (HIF) stabilizers represent an emerging class of therapeutics that allows for increasing erythropoiesis in patients. BAY 85-3934 is a novel HIF stabilizer, which is currently undergoing phase-2 clinical trials. Consequently, the comprehensive characterization of BAY 85-3934 and human urinary metabolites as well as the implementation of these analytes into routine doping controls is of great importance. The mass spectrometric behaviour of the HIF stabilizer drug candidate BAY 85-3934 and a glucuronidated metabolite (BAY-348) were characterized by electrospray ionization-(tandem) mass spectrometry (ESI-MS(/MS)) and multiple-stage mass spectrometry (MS n ). Subsequently, two different laboratories established different analytical approaches (one each) enabling urine sample analyses by employing either direct urine injection or solid-phase extraction. The methods were cross-validated for the metabolite BAY-348 that is expected to represent an appropriate target analyte for human urine analysis. Two test methods allowing for the detection of BAY-348 in human urine were applied and cross-validated concerning the validation parameters specificity, linearity, lower limit of detection (LLOD; 1-5 ng/mL), ion suppression/enhancement (up to 78%), intra- and inter-day precision (3-21%), recovery (29-48%), and carryover. By means of ten spiked test urine samples sent blinded to one of the participating laboratories, the fitness-for-purpose of both assays was provided as all specimens were correctly identified applying both testing methods. As no post-administration study samples were available, analyses of authentic urine specimens remain desirable. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Utility of High Throughput Screening Techniques to Predict Stability of Monoclonal Antibody Formulations During Early Stage Development.

PubMed

Goldberg, Deborah S; Lewus, Rachael A; Esfandiary, Reza; Farkas, David C; Mody, Neil; Day, Katrina J; Mallik, Priyanka; Tracka, Malgorzata B; Sealey, Smita K; Samra, Hardeep S

2017-08-01

Selecting optimal formulation conditions for monoclonal antibodies for first time in human clinical trials is challenging due to short timelines and reliance on predictive assays to ensure product quality and adequate long-term stability. Accelerated stability studies are considered to be the gold standard for excipient screening, but they are relatively low throughput and time consuming. High throughput screening (HTS) techniques allow for large amounts of data to be collected quickly and easily, and can be used to screen solution conditions for early formulation development. The utility of using accelerated stability compared to HTS techniques (differential scanning light scattering and differential scanning fluorescence) for early formulation screening was evaluated along with the impact of excipients of various types on aggregation of monoclonal antibodies from multiple IgG subtypes. The excipient rank order using quantitative HTS measures was found to correlate with accelerated stability aggregation rate ranking for only 33% (by differential scanning fluorescence) to 42% (by differential scanning light scattering) of the antibodies tested, due to the high intrinsic stability and minimal impact of excipients on aggregation rates and HTS data. Also explored was a case study of employing a platform formulation instead of broader formulation screening for early formulation development. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Preliminary study of the biomechanical behavior and physical characteristics of tantalum (Ta)-coated prostheses.

PubMed

Duan, Yonghong; Liu, Lie; Wang, Ling; Guo, Fei; Li, Haoping; Shi, Lei; Li, Mao; Yin, Dayu; Jiang, Chi; Zhu, Qingsheng

2012-03-01

Use of Ta biomaterials in medicine started in the middle of the last century. The good biocompatibility and chemical stability, and the unique physical characteristics of Ta metal have resulted in many possible developments of Ta biomaterials. In this study, histopathological observation, histomorphometric analysis, scanning electron microscope (SEM) observation, energy-dispersive X-ray spectroscopy (EDX) analysis, biomechanical testing, and examination of the coating's mechanical strength have been used to evaluate the value of clinical application of Ta-coated prostheses prepared by a plasma-spraying process. Histopathological observation has demonstrated that the periprosthetic new bone tissues tightly and stably adhere to the Ta coating after the implantation, with no signs of loosening. Early after implantation, there is no significant difference in periprosthetic bone volume and ultimate shear strength between Ta-coated and Ti-coated prostheses (P > 0.05). EDX analysis suggests that the ultimate shear stress does not damage Ta coating. Mechanical strength testing shows that the adhesive strength and Vicker's surface hardness (HV) of the Ta coating are significantly higher than those of the Ti coating (P < 0.01). Ta coating has good stability and bone biocompatibility; the extraordinary physical characteristics of Ta coating have great significance in maintaining prosthetic stability and surface porosity after implantation.

Twenty-first century mast cell stabilizers

PubMed Central

Finn, D F; Walsh, J J

2013-01-01

Mast cell stabilizing drugs inhibit the release of allergic mediators from mast cells and are used clinically to prevent allergic reactions to common allergens. Despite the relative success of the most commonly prescribed mast cell stabilizer, disodium cromoglycate, in use for the preventative treatment of bronchial asthma, allergic conjunctivitis and vernal keratoconjunctivitis, there still remains an urgent need to design new substances that are less expensive and require less frequent dosing schedules. In this regard, recent developments towards the discovery of the next generation of mast cell stabilizing drugs has included studies on substances isolated from natural sources, biological, newly synthesized compounds and drugs licensed for other indications. The diversity of natural products evaluated range from simple phenols, alkaloids, terpenes to simple amino acids. While in some cases their precise mode of action remains unknown it has nevertheless sparked interest in the development of synthetic derivatives with improved pharmacological properties. Within the purely synthetic class of inhibitors, particular attention has been devoted to the inhibition of important signalling molecules including spleen TK and JAK3. The statin class of cholesterol-lowering drugs as well as nilotinib, a TK inhibitor, are just some examples of clinically used drugs that have been evaluated for their anti-allergic properties. Here, we examine each approach under investigation, summarize the test data generated and offer suggestions for further preclinical evaluation before their therapeutic potential can be realized. Linked Articles This article is part of a themed issue on Histamine Pharmacology Update. To view the other articles in this issue visit http://dx.doi.org/10.1111/bph.2013.170.issue-1 PMID:23441583

Differentiation of antiinflammatory and antitumorigenic properties of stabilized enantiomers of thalidomide analogs

PubMed Central

Jacques, Vincent; Czarnik, Anthony W.; Judge, Thomas M.; Van der Ploeg, Lex H. T.; DeWitt, Sheila H.

2015-01-01

Therapeutics developed and sold as racemates can exhibit a limited therapeutic index because of side effects resulting from the undesired enantiomer (distomer) and/or its metabolites, which at times, forces researchers to abandon valuable scaffolds. Therefore, most chiral drugs are developed as single enantiomers. Unfortunately, the development of some chirally pure drug molecules is hampered by rapid in vivo racemization. The class of compounds known as immunomodulatory drugs derived from thalidomide is developed and sold as racemates because of racemization at the chiral center of the 3-aminoglutarimide moiety. Herein, we show that replacement of the exchangeable hydrogen at the chiral center with deuterium allows the stabilization and testing of individual enantiomers for two thalidomide analogs, including CC-122, a compound currently in human clinical trials for hematological cancers and solid tumors. Using “deuterium-enabled chiral switching” (DECS), in vitro antiinflammatory differences of up to 20-fold are observed between the deuterium-stabilized enantiomers. In vivo, the exposure is dramatically increased for each enantiomer while they retain similar pharmacokinetics. Furthermore, the single deuterated enantiomers related to CC-122 exhibit profoundly different in vivo responses in an NCI-H929 myeloma xenograft model. The (−)-deuterated enantiomer is antitumorigenic, whereas the (+)-deuterated enantiomer has little to no effect on tumor growth. The ability to stabilize and differentiate enantiomers by DECS opens up a vast window of opportunity to characterize the class effects of thalidomide analogs and improve on the therapeutic promise of other racemic compounds, including the development of safer therapeutics and the discovery of new mechanisms and clinical applications for existing therapeutics. PMID:25775521

Developments in the formulation and delivery of spray dried vaccines.

PubMed

Kanojia, Gaurav; Have, Rimko Ten; Soema, Peter C; Frijlink, Henderik; Amorij, Jean-Pierre; Kersten, Gideon

2017-10-03

Spray drying is a promising method for the stabilization of vaccines, which are usually formulated as liquids. Usually, vaccine stability is improved by spray drying in the presence of a range of excipients. Unlike freeze drying, there is no freezing step involved, thus the damage related to this step is avoided. The edge of spray drying resides in its ability for particles to be engineered to desired requirements, which can be used in various vaccine delivery methods and routes. Although several spray dried vaccines have shown encouraging preclinical results, the number of vaccines that have been tested in clinical trials is limited, indicating a relatively new area of vaccine stabilization and delivery. This article reviews the current status of spray dried vaccine formulations and delivery methods. In particular it discusses the impact of process stresses on vaccine integrity, the application of excipients in spray drying of vaccines, process and formulation optimization strategies based on Design of Experiment approaches as well as opportunities for future application of spray dried vaccine powders for vaccine delivery.

Effects of chemical disinfectant solutions on the stability and accuracy of the dental impression complex.

PubMed

Rios, M P; Morgano, S M; Stein, R S; Rose, L

1996-10-01

Currently available impression materials were not designed for disinfection or sterilization, and it is conceivable that disinfectants may adversely affect impressions. This study evaluated the accuracy and dimensional stability of polyether (Permadyne/Impregum) and polyvinyl siloxane (Express) impression materials retained by their adhesives in two different acrylic resin tray designs (perforated and nonperforated) when the materials were immersed for either 30 or 60 minutes in three high-level disinfectants. Distilled water and no solution served as controls. A stainless steel test analog similar to ADA specification No. 19 was used. A total of 400 impressions were made with all combinations of impression materials, tray designs, disinfectant, and soaking times. Samples were evaluated microscopically before and after immersion and 48 hours after soaking. Results indicated that these two impression materials were dimensionally stable. Because the results emphasized the stability and accuracy of the impression complex under various conditions, dentists can perform disinfection procedures similar to the protocol of this study without concern for clinically significant distortion of the impression.

In vitro simulation of pathological bone conditions to predict clinical outcome of bone tissue engineered materials

NASA Astrophysics Data System (ADS)

Nguyen, Duong Thuy Thi

According to the Centers for Disease Control, the geriatric population of ≥65 years of age will increase to 51.5 million in 2020; 40% of white women and 13% of white men will be at risk for fragility fractures or fractures sustained under normal stress and loading conditions due to bone disease, leading to hospitalization and surgical treatment. Fracture management strategies can be divided into pharmaceutical therapy, surgical intervention, and tissue regeneration for fracture prevention, fracture stabilization, and fracture site regeneration, respectively. However, these strategies fail to accommodate the pathological nature of fragility fractures, leading to unwanted side effects, implant failures, and non-unions. Compromised innate bone healing reactions of patients with bone diseases are exacerbated with protective bone therapy. Once these patients sustain a fracture, bone healing is a challenge, especially when fracture stabilization is unsuccessful. Traditional stabilizing screw and plate systems were designed with emphasis on bone mechanics rather than biology. Bone grafts are often used with fixation devices to provide skeletal continuity at the fracture gap. Current bone grafts include autologous bone tissue and donor bone tissue; however, the quality and quantity demanded by fragility fractures sustained by high-risk geriatric patients and patients with bone diseases are not met. Consequently, bone tissue engineering strategies are advancing towards functionalized bone substitutes to provide fracture reconstruction while effectively mediating bone healing in normal and diseased fracture environments. In order to target fragility fractures, fracture management strategies should be tailored to allow bone regeneration and fracture stabilization with bioactive bone substitutes designed for the pathological environment. The clinical outcome of these materials must be predictable within various disease environments. Initial development of a targeted treatment strategy should focus on simulating, in vitro, a physiological bone environment to predict clinical effectiveness of engineered bone and understand cellular responses due to the proposed agents and bioactive scaffolds. An in vitro test system can be the necessary catalyst to reduce implant failures and non-unions in fragility fractures.

New developments in anti-sickling agents: can drugs directly prevent the polymerization of sickle haemoglobin in vivo?

PubMed

Oder, Esther; Safo, Martin K; Abdulmalik, Osheiza; Kato, Gregory J

2016-10-01

The hallmark of sickle cell disease is the polymerization of sickle haemoglobin due to a point mutation in the β-globin gene (HBB). Under low oxygen saturation, sickle haemoglobin assumes the tense (T-state) deoxygenated conformation that can form polymers, leading to rigid erythrocytes with impaired blood vessel transit, compounded or initiated by adhesion of erythrocytes to endothelium, neutrophils and platelets. This process results in vessel occlusion and ischaemia, with consequent acute pain, chronic organ damage, morbidity and mortality. Pharmacological agents that stabilize the higher oxygen affinity relaxed state (R-state) and/or destabilize the lower oxygen affinity T-state of haemoglobin have the potential to delay the sickling of circulating red cells by slowing polymerization kinetics. Relevant classes of agents include aromatic aldehydes, thiol derivatives, isothiocyanates and acyl salicylates derivatives. The aromatic aldehyde, 5-hydroxymethylfurfural (5-HMF) increases oxygen affinity of sickle haemoglobin and reduces hypoxia-induced sickling in vitro and protects sickle cell mice from effects of hypoxia. It has completed pre-clinical testing and has entered clinical trials as treatment for sickle cell disease. A related molecule, GBT440, has shown R-state stabilization and increased oxygen affinity in preclinical testing. Allosteric modifiers of haemoglobin as direct anti-sickling agents target the fundamental pathophysiological mechanism of sickle cell disease. © 2016 John Wiley & Sons Ltd.

Oral antioxidant therapy for marginal dry eye.

PubMed

Blades, K J; Patel, S; Aidoo, K E

2001-07-01

To assess the efficacy of an orally administered antioxidant dietary supplement for managing marginal dry eye. A prospective, randomised, placebo controlled trial with cross-over. Eye Clinic, Department of Vision Sciences, Glasgow Caledonian University. Forty marginal dry eye sufferers composed of 30 females and 10 males (median age 53 y; range 38-69 y). Baseline assessments were made of tear volume sufficiency (thread test), tear quality (stability), ocular surface status (conjunctival impression cytology) and dry eye symptoms (questionnaire). Each subject was administered courses of active treatment, placebo and no treatment, in random order for 1 month each and results compared to baseline. Tear stability and ocular surface status were significantly improved following active treatment (P<0.05). No changes from baseline were detected following administration of placebo and no treatment (P>0.05). Absolute increase in tear stability correlated with absolute change in goblet cell population density. Tear volume was not improved following any treatment period and dry eye symptom responses were subject to placebo effect. Oral antioxidants improved both tear stability and conjunctival health, although it is not yet understood whether increased ocular surface health mediates increased tear stability or vice versa. This study was supported by a PhD scholarship funded by the Department of Vision Sciences, Glasgow Caledonian University, Scotland. Antioxidant supplements and placebos were kindly donated by Vitabiotics.

Hypoxia-inducible factor stabilizers and other small-molecule erythropoiesis-stimulating agents in current and preventive doping analysis.

PubMed

Beuck, Simon; Schänzer, Wilhelm; Thevis, Mario

2012-11-01

Increasing the blood's capacity for oxygen transport by erythropoiesis-stimulating agents (ESAs) constitutes a prohibited procedure of performance enhancement according to the World Anti-Doping Agency (WADA). The advent of orally bio-available small-molecule ESAs such as hypoxia-inducible factor (HIF) stabilizers in the development of novel anti-anaemia therapies expands the list of potential ESA doping techniques. Here, the erythropoiesis-stimulating properties and doping relevance of experimental HIF-stabilizers, such as cobaltous chloride, 3,4-dihydroxybenzoic acid or GSK360A, amongst others, are discussed. The stage of clinical trials is reviewed for the anti-anaemia drug candidates FG-2216, FG-4592, GSK1278863, AKB-6548, and BAY85-3934. Currently available methods and strategies for the determination of selected HIF stabilizers in sports drug testing are based on liquid chromatography-electrospray ionization-tandem mass spectrometry (LC-ESI-MS/MS). For the support of further analytical assay development, patents claiming distinct compounds for the use in HIF-mediated therapies are evaluated and exemplary molecular structures of HIF stabilizers presented. Moreover, data concerning the erythropoiesis-enhancing effects of the GATA inhibitors K7174 and K11706 as well as the lipidic small-molecule ESA PBI-1402 are elucidated the context of doping analysis. Copyright © 2012 John Wiley & Sons, Ltd.

Biomechanical analysis for primary stability of shoulder arthrodesis in different resection situations.

PubMed

Lerch, Solveig; Keller, Sebastian; Kirsch, Ludger; Berndt, Thomas; Rühmann, Oliver

2013-07-01

Only very few publications dealing with shoulder arthrodesis after bone resection procedures and no biomechanical studies are available. The presented biomechanical analysis should ascertain the type of arthrodesis with the highest primary stability in different bone loss situations. On 24 fresh cadaveric shoulder specimens three different bone loss situations were investigated under the stress of abduction, adduction, anteversion and retroversion without destruction by the use of a material testing machine. In each of the testings a 16-hole reconstruction plate was used and compared to arthrodesis with an additional dorsal 6-hole plate. The primary stability of shoulder arthrodesis with a 16-hole reconstruction plate after humeral head resection could be increased significantly if an additional dorsal plate was used. However, no significant improvement with the additional plate was detected after resection of the acromion. Of all investigated forms, arthrodesis after humeral head resection with additional plate showed the highest and arthrodesis after humeral head resection without additional plate showed the lowest force values. The mean values for forces achieved in abduction and adduction were considerably higher than those in anteversion and retroversion. There are no consistent specifications of arthrodesis techniques after resection situation available, thus the presented biomechanical testings give important information about the most stable form of arthrodesis in different types of bone loss. These findings provide an opportunity to minimize complications such as pseudarthrosis for a satisfying clinical outcome. Copyright © 2013 Elsevier Ltd. All rights reserved.

[Augmentation technique on the proximal humerus].

PubMed

Scola, A; Gebhard, F; Röderer, G

2015-09-01

The treatment of osteoporotic fractures is still a challenge. The advantages of augmentation with respect to primary in vitro stability and the clinical use for the proximal humerus are presented in this article. In this study six paired human humeri were randomized into an augmented and a non-augmented group. Osteosynthesis was performed with a PHILOS plate (Synthes®). In the augmented group the two screws finding purchase in the weakest cancellous bone were augmented. The specimens were tested in a 3-part fracture model in a varus bending test. The augmented PHILOS plates withstood significantly more load cycles until failure. The correlation to bone mineral density (BMD) showed that augmentation could partially compensate for low BMD. The augmentation of the screws in locked plating in a proximal humerus fracture model is effective in improving the primary stability in a cyclic varus bending test. The targeted augmentation of two particular screws in a region of low bone quality within the humeral head was almost as effective as four screws with twice the amount of bone cement. Screw augmentation combined with a knowledge of the local bone quality could be more effective in enhancing the primary stability of a proximal humerus locking plate because the effect of augmentation can be exploited more effectively limiting it to the degree required. The technique of augmentation is simple and can be applied in open and minimally invasive procedures. When the correct procedure is used, complications (cement leakage into the joint) can be avoided.

Stability Testing of Herbal Drugs: Challenges, Regulatory Compliance and Perspectives.

PubMed

Bansal, Gulshan; Suthar, Nancy; Kaur, Jasmeen; Jain, Astha

2016-07-01

Stability testing is an important component of herbal drugs and products (HDPs) development process. Drugs regulatory agencies across the globe have recommended guidelines for the conduct of stability studies on HDPs, which require that stability data should be included in the product registration dossier. From the scientific viewpoint, numerous chemical constituents in an herbal drug are liable to varied chemical reactions under the influence of different conditions during its shelf life. These reactions can lead to altered chemical composition of HDP and consequently altered therapeutic profile. Many reports on stability testing of HDPs have appeared in literature since the last 10 years. A review of these reports reveals that there is wide variability in temperature (-80 to 100 °C), humidity (0-100%) and duration (a few hours-36 months) for stability assessment of HDPs. Of these, only 1% studies are conducted in compliance with the regulatory guidelines for stability testing. The present review is aimed at compiling all stability testing reports, understanding key challenges in stability testing of HDPs and suggesting possible solutions for these. The key challenges are classified as chemical complexity and biochemical composition variability in raw material, selection of marker(s) and influences of enzymes. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Stability of yttria-stabilized zirconia during pyroprocessing tests

NASA Astrophysics Data System (ADS)

Choi, Eun-Young; Lee, Jeong; Lee, Sung-Jai; Kim, Sung-Wook; Jeon, Sang-Chae; Cho, Soo Haeng; Oh, Seung Chul; Jeon, Min Ku; Lee, Sang Kwon; Kang, Hyun Woo; Hur, Jin-Mok

2016-07-01

In this study, the feasibility of yttria-stabilized zirconia (YSZ) was investigated for use as a ceramic material, which can be commonly used for both electrolytic reduction and electrorefining. First, the stability of YSZ in salts for electrolytic reduction and electrorefining was examined. Then, its stability was demonstrated by a series of pyroprocessing tests, such as electrolytic reduction, LiCl distillation, electrorefining, and LiClsbnd KCl distillation, using a single stainless steel wire mesh basket containing fuel and YSZ. A single basket was used by its transportation from one test to subsequent tests without the requirements for unloading.

A clinical evaluation denture adhesives used by patients with xerostomia.

PubMed

Bogucki, Zdzislaw A; Napadlek, Piotr; Dabrowa, Tomasz

2015-02-01

The purpose of study was to analyze the participants' opinions concerning the effectiveness of 6 denture adhesives (DA). The study group included 60 participants. Criteria for selecting the patients were as follows: reduced retention and stabilization of maxillary complete dentures and xerostomia. These features were evaluated on basis of clinical examination and standard sialometry tests (u-SFR). Retention of maxillary dentures was scored by modified Kapur index before application of DA. All participants were divided randomly into 6 groups regarding the use of the 6 DA during a 6-month period. After this time, participants completed an HRQL questionnaire. DA noticeably improved retention and stabilization of maxillary complete dentures. DA in the glue form had the best retention effectiveness in participants with xerostomia. These materials are difficult to clean from the denture base. The data are presented in tables and figures. The results of the study collected positive influence of adhesives on retention of dentures in xerostomia patients. The cleaning dentures and denture bearing tissues was difficult. DA help in the use of prostheses, but it is also necessary for the treatment of the causes and symptoms of xerostomia.

Long term stability of cannabinoids in oral fluid after controlled cannabis administration

PubMed Central

Swortwood, Madeleine J; Sempio, Cristina; Huestis, Marilyn A.

2016-01-01

Cannabinoid stability in oral fluid (OF) is important for assuring accurate results since OF has become a valid alternative matrix of choice for drug testing. We previously published OF cannabinoid stability studies using Quantisal™, Oral-Eze®, and StatSure™ devices stored at room temperature for 1 week, 4°C for up to 4 weeks and in −20°C up to 24 weeks. Extending refrigerated stability up to 3 months would be helpful for clinical and forensic testing, for reanalysis of OF samples and for batching research analyses. Individual authentic OF pools were prepared after controlled smoking of a 6.9% Δ9-tetrahydracannabinol cannabis cigarette; the Quantisal™ device was utilized for OF collection. Fifteen healthy volunteers participated in the Institutional Review Board approved study. Stability for THC, 11-nor-9-carboxy-THC (THCCOOH), Δ9-tetrahydrocannabivarin (THCV), cannabidiol (CBD) and cannabigerol (CBG) were determined after storage at 4°C for 1, 2 and 3 months. Results within ±20% of baseline concentrations were considered stable. All analytes were stable for up to 2 months at 4°C for all participants with positive baseline concentrations. Baseline concentrations were highly variable. In total, THC, THCCOOH, THCV, CBD and CBG were stable for 3 months at 4°C for pooled positive specimens from 14 of 15, 8 of 9, 7 of 8, 8 of 9 and 9 of 10 participants, respectively. In conclusion, Quantisal™ collected OF specimens should be stored at 4°C for no more than 2 months to assure accurate THC, THCCOOH, THCV, CBD and CBG quantitative results; only one participant's OF was unstable at 3 months. PMID:27539096

Disparity between Clinical and Ultrasound Examinations in Neonatal Hip Screening.

PubMed

Kyung, Bong Soo; Lee, Soon Hyuck; Jeong, Woong Kyo; Park, Si Young

2016-06-01

For early detection of developmental dysplasia of the hip (DDH), neonatal hip screening using clinical examination and/or ultrasound has been recommended. Although there have been many studies on the reliability of both screening techniques, there is still controversy in the screening strategies; clinical vs. selective or universal ultrasound screening. To determine the screening strategy, we assessed the agreement among the methods; clinical examination by an experienced pediatric orthopedic surgeon, sonographic morphology, and sonographic stability. From January 2004 to June 2009, a single experienced pediatric orthopedic surgeon performed clinical hip screenings for 2,686 infants in the neonatal unit and 43 infants who were referred due to impressions of hip dysplasia before 3 months of age. Among them, 156 clinically unstable or high-risk babies selectively received bilateral hip ultrasound examinations performed by the same surgeon using the modified Graf method. The results were analyzed statistically to detect any correlations between the clinical and sonographic findings. Although a single experienced orthopedic surgeon conducted all examinations, we detected only a limited relationship between the results of clinical and ultrasound examinations. Ninety-three percent of the clinically subluxatable hips were normal or immature based on static ultrasound examination, and 74% of dislocating hips and 67% of limited abduction hips presented with the morphology below Graf IIa. A total of 80% of clinically subluxatable, 42% of dislocating and 67% of limited abduction hips appeared stable or exhibited minor instability on dynamic ultrasound examination. About 7% of clinically normal hips were abnormal upon ultrasound examination; 5% showed major instability and 3% showed dysplasia above Graf IIc. Clinical stability had small coefficients between ultrasound examinations; 0.39 for sonographic stability and 0.37 for sonographic morphology. Between sonographic stability and morphology, although 71% of hips with major instability showed normal or immature morphology according to static ultrasound examination, the coefficient was as high as 0.64. Discrepancies between clinical and ultrasound examinations were present even if almost all of the exams were performed by a single experienced pediatric orthopedic surgeon. In relation to screening for DDH, it is recommended that both sonographic morphology and stability be checked in addition to clinical examination.

Effect of textured foot orthotics on static and dynamic postural stability in middle-aged females.

PubMed

Wilson, Marjorie L; Rome, Keith; Hodgson, David; Ball, Peter

2008-01-01

Foot orthotics (FO) may be prescribed for a range of lower limb and foot conditions. Prior studies report use of FO in enhancing postural stability in healthy younger adults, and do not control for footwear type. Currently, interest in the effects of FO on postural stability in older adults has increased. Limited reports exist of the effects on postural stability of FO made of combinations of materials, thicknesses and surface textures. In this study 40 healthy females (51.1+/-5.8 years) recruited into a within subject test-retest randomised clinical trial were provided with identical footwear and randomised into four FO conditions (control, grid, dimple and plain, n=10 for each condition). Participants wore the footwear for 4 weeks, a minimum of 6h/day. A Kistler force plate was used to determine postural stability variables (anterior-posterior displacements and medial-lateral displacements) for each participant in a static position, with eyes open and eyes closed. Base of support was evaluated using the GAITRite system. Each outcome measure was measured at baseline and 4 weeks. Postural stability variables demonstrated no significant differences between the four FO conditions. No significant differences were observed with base of support between the four conditions. We have demonstrated no detrimental effects on postural stability in older females after 4 weeks. This is regardless of orthotic texture and is independent of footwear. Biomechanical or sensory effects of FO on postural stability are still to be determined. These may be dependent on the geometry and texture of the orthotic.

Cemented total knee replacement in 24 dogs: surgical technique, clinical results, and complications.

PubMed

Allen, Matthew J; Leone, Kendall A; Lamonte, Kimberly; Townsend, Katy L; Mann, Kenneth A

2009-07-01

To characterize the performance of cemented total knee replacement (TKR) in dogs. Preclinical research study. Skeletally mature, male Hounds (25-30 kg; n=24) with no preexisting joint pathology. Dogs had unilateral cemented TKR and were evaluated at 6, 12, 26, or 52 weeks (6 dogs/time point) by radiography, bone density analysis, visual gait assessment, and direct measurement of thigh circumference and stifle joint range of motion as indicators of functional recovery. At study end, the stability of the cemented tibial component was determined by destructive mechanical testing. Joint stability was excellent in 16 dogs (67%) and good in 8 dogs. None of the tibial components had evidence of migration or periprosthetic osteolysis whereas 1 femoral component was loose at 52 weeks. There was an early and significant decrease in tibial bone density, likely because of disuse of the operated limb. Dogs returned to full activity by 12 weeks. The tibial cement-bone interface maintained its strength over 52 weeks. Cement provides stable fixation of the tibial component in canine TKR. Cemented TKR yields adequate clinical function and stifle joint excursion in the dog. Clinical studies are needed to determine the long-term fate of cemented TKR implants, to assess the influence of implant design on implant fixation and wear, and to obtain objective functional data.

A silicone elastomer vaginal ring for HIV prevention containing two microbicides with different mechanisms of action.

PubMed

Fetherston, Susan M; Boyd, Peter; McCoy, Clare F; McBride, Marcella C; Edwards, Karen-Leigh; Ampofo, Stephen; Malcolm, R Karl

2013-02-14

Vaginal rings are currently being developed for the long-term (at least 30 days) continuous delivery of microbicides against human immunodeficiency virus (HIV). Research to date has mostly focused on devices containing a single antiretroviral compound, exemplified by the 25mg dapivirine ring currently being evaluated in a Phase III clinical study. However, there is a strong clinical rationale for combining antiretrovirals with different mechanisms of action in a bid to increase breadth of protection and limit the emergence of resistant strains. Here we report the development of a combination antiretroviral silicone elastomer matrix-type vaginal ring for simultaneous controlled release of dapivirine, a non-nucleoside reverse transcriptase inhibitor, and maraviroc, a CCR5-targeted HIV-1 entry inhibitor. Vaginal rings loaded with 25mg dapivirine and various quantities of maraviroc (50-400mg) were manufactured and in vitro release assessed. The 25mg dapivirine and 100mg maraviroc formulation was selected for further study. A 24-month pharmaceutical stability evaluation was conducted, indicating good product stability in terms of in vitro release, content assay, mechanical properties and related substances. This combination ring product has now progressed to Phase I clinical testing. Copyright © 2012 Elsevier B.V. All rights reserved.

Field testing of fugitive dust control techniques at a uranium mill tailings pile - 1982 Field Test, Gas Hills, Wyoming.

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

Elmore, M.R.; Hartley, J.N.

A field test was conducted on a uranium tailings pile to evaluate the effectiveness of 15 chemical stabilizers for control of fugitive dust from uranium mill tailings. A tailings pile at the Federal American Partners (FAP) Uranium Mill, Gas Hills, Wyoming, was used for the field test. Preliminary laboratory tests using a wing tunnel were conducted to select the more promising stabilizers for field testing. Fourteen of the chemical stabilizers were applied with a field spray system pulled behind a tractor; one--Hydro Mulch--was applied with a hydroseeder. A portable weather station and data logger were installed to record the weathermore » conditions at the test site. After 1 year of monitoring (including three site visits), all of the stabilizers have degraded to some degree; but those applied at the manufacturers' recommended rate are still somewhat effective in reducing fugitive emissions. The following synthetic polymer emulsions appear to be the more effective stabilizers: Wallpol 40-133 from Reichold Chemicals, SP-400 from Johnson and March Corporation, and CPB-12 from Wen Don Corporation. Installed costs for the test plots ranged from $8400 to $11,300/ha; this range results from differences in stabilizer costs. Large-scale stabilization costs of the test materials are expected to range from $680 to $3600/ha based on FAP experience. Evaluation of the chemical stabilizers will continue for approximately 1 year. 2 references, 33 figures, 22 tables.« less

Evaluation in vitro of the tensile strength of crimpable hooks used for stabilization in orthognathic surgery.

PubMed

Andrade Gomes, Nascimento Leonard Euller; Melo, Pithon Matheus; Lacerda, Santos Rogério; D'Albuquerque, Medeiros Paulo Jose

2012-03-01

The aim of this study was to evaluate the tensile strength of crimpable hooks used for arch stabilization in orthognatic surgery. Ninety stainless steel wire (0.019" × 0.026") segments, each measuring 6 cm long, were used and attached to crimpable hooks of different commercial brands. Six groups were formed (n = 10) denominated as follows: control, in which the wire segments were perpendicularly welded by spot welding machine; and the hooks groups M (Morelli), MS (Morelli with weld), TP (TP Ortho), TPS (TP with weld), TPTg (TP-tungsten), TPTgS (TP-tungsten with weld), AO (American Orthodontics), and AOS (American Orthodontics with weld). The test specimen topography was evaluated by scanning electron microscopy before and after the tensile strength tests. After obtaining the results, the analysis of variance and Kruskal-Wallis multiple-comparison tests were applied. Compared with the control group, the AOS ball hooks and those from TPS required a greater amount of force to be displaced along the rectangular arch. The hooks in group M were significantly easier to displace, followed by those from AO. The best ball hooks for clinical application are those from AOS and TPS. Copyright © 2012 Elsevier Inc. All rights reserved.

Clinical comparison of a novel extracapsular stabilization procedure and tibial plateau leveling osteotomy for treatment of cranial cruciate ligament deficiency in dogs.

PubMed

Cook, James L; Luther, Jill K; Beetem, Jodi; Karnes, Josh; Cook, Cristi R

2010-04-01

To develop and test a novel extracapsular technique, TightRope CCL technique (TR), and compare its 6-month clinical outcomes to tibial plateau leveling osteotomy (TPLO) in dogs with cranial cruciate ligament (CCL) deficiency. Prospective clinical cohort study. Medium, large, and giant breed dogs (n=47) with CCL deficiency. Before clinical use, TR was evaluated by mechanical testing and the surgical technique was developed and evaluated in canine cadavers. For the clinical study, dogs were assigned to either TR (n=24) or TPLO (n=23) groups and the assigned technique performed after arthroscopic assessment and treatment of joint pathology. Postoperative management was standardized for both groups. Outcome measures were performed immediately postoperatively and up to 6 months after surgery and included complication types and rate, subjective measurement of cranial drawer and tibial thrust, subjective assessment of radiographic progression of osteoarthritis (OA), and function using a validated client questionnaire (6 months only). TR with a fiber tape suture had superior mechanical properties for creep, stiffness, yield load, and load at failure. Duration of anesthesia, total surgical time, and stabilization procedure (TR versus TPLO) were all significantly (P<.001) shorter for TR compared with TPLO. Complications requiring further treatment occurred in 12.5% of TR cases and 17.4% of TPLO cases. No significant differences were noted between groups for cranial tibial thrust, but cranial drawer was significantly (P<.05) lower in TR stifles at all postoperative time points. No significant differences were noted between groups for radiographic OA scores. No statistically or clinically significant differences were noted between TR and TPLO for scores for each of the client questionnaire categories. TR resulted in 6-month outcomes that were not different than TPLO in terms of radiographic progression of OA and client-evaluated level of function. TR was associated with shorter anesthesia and surgery times as well as a lower complication rate. The TR technique is safe and effective and can be considered an appropriate surgical option as part of the overall treatment plan for CCL deficiency in dogs.

49 CFR 173.65 - Exceptions for Division 1.4G consumer fireworks.

Code of Federal Regulations, 2014 CFR

2014-10-01

...) The device must pass a thermal stability test. The test must be performed by maintaining the device... thermal stability test; (3) The manufacturer of the Division 1.4G consumer firework applies in writing to... thermal stability test; and (iv) Signed certification declaring that the device for which certification is...

49 CFR 173.65 - Exceptions for Division 1.4G consumer fireworks.

Code of Federal Regulations, 2013 CFR

2013-10-01

...) The device must pass a thermal stability test. The test must be performed by maintaining the device... thermal stability test; (3) The manufacturer of the Division 1.4G consumer firework applies in writing to... thermal stability test; and (iv) Signed certification declaring that the device for which certification is...

HPLC and HPLC/MS/MS Studies on Stress, Accelerated and Intermediate Degradation Tests of Antivirally Active Tricyclic Analog of Acyclovir.

PubMed

Lesniewska, Monika A; Dereziński, Paweł; Klupczyńska, Agnieszka; Kokot, Zenon J; Ostrowski, Tomasz; Zeidler, Joanna; Muszalska, Izabela

2015-01-01

The degradation behavior of a tricyclic analog of acyclovir [6-(4-MeOPh)-TACV] was determined in accordance with International Conference on Harmonization guidelines for good clinical practice under different stress conditions (neutral hydrolysis, strong acid/base degradation, oxidative decomposition, photodegradation, and thermal degradation). Accelerated [40±2°C/75%±5% relative humidity (RH)] and intermediate (30±2°C/65%±5% RH) stability tests were also performed. For observation of the degradation of the tested compound the RP-HPLC was used, whereas for the analysis of its degradation products HPLC/MS/MS was used. Degradation of the tested substance allowed its classification as unstable in neutral environment, acidic/alkaline medium, and in the presence of oxidizing agent. The tested compound was also light sensitive and was classified as photolabile both in solution and in the solid phase. However, the observed photodegradation in the solid phase was at a much lower level than in the case of photodegradation in solution. The study showed that both air temperature and RH had no significant effect on the stability of the tested substance during storage for 1 month at 100°C (dry heat) as well as during accelerated and intermediate tests. Based on the HPLC/MS/MS analysis, it can be concluded that acyclovir was formed as a degradation product of 6-(4-MeOPh)-TACV.

Low-Speed Stability and Control Test of a "Double-Bubble" Transport Configuration

NASA Technical Reports Server (NTRS)

Vicroy, Dan D.

2017-01-01

A test in the Langley 12-Foot Low-Speed Tunnel was conducted as a risk mitigation effort to quickly obtain some low-speed stability and control data on a "double-bubble" or D8 transport configuration. The test also tested some configuration design trades. A 5-percent scale model was tested with stabilizer, elevator, rudder and aileron control deflections. This report summarizes the test results.

Group and individual stability of three parenting dimensions

PubMed Central

2011-01-01

Background The Parental Bonding Instrument, present self-report version, (PBI-PCh) includes three scales, Warmth, Protectiveness and Authoritarianism, which describe three dimensions of current parenting. The purposes of this study were to (1) evaluate the true and observed stability of these parenting dimensions related to older children, (2) explore the distribution of individual-level change across nine months and (3) test potential parental predictors of parenting instability. Methods Questionnaires were distributed to school-based samples of community parents of both genders (n = 150) twice, nine months apart. These questionnaires measured parenting, parental personality and emotional symptoms. Results Based on 1) stability correlations, 2) true stability estimates from structural equation modeling (SEM) and 3) distribution of individual-level change, Warmth appeared rather stable, although not as stable as personality traits. Protectiveness was moderately stable, whereas Authoritarianism was the least stable parenting dimension among community parents. The differences in stability between the three dimensions were consistent in both estimated true stability and observed stability. Most of the instability in Warmth originated from a minority of parents with personality, childhood care characteristics and lower current parenting warmth. For the Protectiveness dimension, instability was associated with higher Protectiveness scores. Conclusions True instability with all three self-reported parenting dimensions can occur across nine months in a community sample related to older children (7-15), but it may occur with varying degrees among dimensions and subpopulations. The highest stability was found for the Warmth parenting dimension, but a subgroup of "unstably cold" parents could be identified. Stability needs to be taken into account when interpreting longitudinal research on parenting and when planning and evaluating parenting interventions in research and clinical practice. PMID:21609442

21 CFR 212.61 - What must I do to ensure the stability of my PET drug products through expiry?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false What must I do to ensure the stability of my PET... the stability of my PET drug products through expiry? (a) Stability testing program. You must... PET drug products. The test methods must be reliable, meaningful, and specific. The samples tested for...

46 CFR 170.190 - Stability test procedure modifications.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 7 2014-10-01 2014-10-01 false Stability test procedure modifications. 170.190 Section 170.190 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) SUBDIVISION AND STABILITY STABILITY REQUIREMENTS FOR ALL INSPECTED VESSELS Determination of Lightweight Displacement and Centers of...

46 CFR 170.190 - Stability test procedure modifications.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 46 Shipping 7 2013-10-01 2013-10-01 false Stability test procedure modifications. 170.190 Section 170.190 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) SUBDIVISION AND STABILITY STABILITY REQUIREMENTS FOR ALL INSPECTED VESSELS Determination of Lightweight Displacement and Centers of...

46 CFR 170.190 - Stability test procedure modifications.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 46 Shipping 7 2012-10-01 2012-10-01 false Stability test procedure modifications. 170.190 Section 170.190 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) SUBDIVISION AND STABILITY STABILITY REQUIREMENTS FOR ALL INSPECTED VESSELS Determination of Lightweight Displacement and Centers of...

46 CFR 170.190 - Stability test procedure modifications.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 7 2010-10-01 2010-10-01 false Stability test procedure modifications. 170.190 Section 170.190 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) SUBDIVISION AND STABILITY STABILITY REQUIREMENTS FOR ALL INSPECTED VESSELS Determination of Lightweight Displacement and Centers of...

46 CFR 170.190 - Stability test procedure modifications.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 7 2011-10-01 2011-10-01 false Stability test procedure modifications. 170.190 Section 170.190 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) SUBDIVISION AND STABILITY STABILITY REQUIREMENTS FOR ALL INSPECTED VESSELS Determination of Lightweight Displacement and Centers of...

Development and Application of a High-Performance Liquid Chromatography Stability-Indicating Assay for Beyond-Use Date Determination of Compounded Topical Gels Containing Multiple Active Drugs.

PubMed

Gorman, Gregory; Sokom, Simara; Coward, Lori; Arnold, John J

2017-01-01

Topical gels compounded by pharmacists are important clinical tools for the management of pain. Nevertheless, there is often a dearth of information about the chemical stability of drugs included in these topical formulations, complicating the assignment of beyond-use dating. The purpose of this study was to develop a high-performance liquid chromatography photodiode array-based stability-indicating assay that could simultaneously resolve six drugs (amitriptyline, baclofen, clonidine, gabapentin, ketoprofen, lidocaine) commonly included in topical gels for pain management and their potential degradation products. Furthermore, this method was applied to the determination of beyond-use dating of combinations of these drugs prepared in commonly utilized bases (Lipobase, Lipoderm, Pluronic organogel). Gabapentin was determined to be the least stable component in all formulations tested. Measured stability ranged between 7 to 49 days depending on the base and other active drugs present in the formulation. In the absence of gabapentin, baclofen was the next least stable component, lasting for 120 days, regardless of the type of formulating base used. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

Conflict Resolution Styles as Mediators of Female Child Sexual Abuse Experience and Heterosexual Couple Relationship Satisfaction and Stability in Adulthood.

PubMed

Knapp, Ashlee E; Knapp, Darin J; Brown, Cameron C; Larson, Jeffry H

2017-01-01

Trauma from female incestuous child sexual abuse may result in negative psychological consequences affecting adult relationships. This study explored relational consequences of incestuous child sexual abuse, focusing on conflict resolution styles, relationship satisfaction, and relationship stability. Using the RELATionship Evaluation dataset, 457 heterosexual couples in which female partners experienced incestuous child sexual abuse were compared to a group of 1,827 couples with no sexual abuse history. Analyses tested differences in the frequencies of reported conflict resolution styles for incestuous child sexual abuse and non-incestuous child sexual abuse groups, the mediating effects of conflict resolution styles on the relationship between incestuous child sexual abuse, and self- and partner-reported relationship satisfaction and stability. Significant differences in the reports of types of conflict resolution styles were found for incestuous child sexual abuse versus non-incestuous child sexual abuse groups. Incestuous child sexual abuse and conflict resolution styles were negatively related to relationship satisfaction and stability and there was a significant indirect effect between female incestuous child sexual abuse, female volatility, and relationship instability. Clinical applications for couple relationships are discussed.

Isolated syndesmosis ankle injury.

PubMed

Valkering, Kars P; Vergroesen, Diederik A; Nolte, Peter A

2012-12-01

Isolated syndesmosis injuries often go unrecognized and are diagnosed as lateral ankle sprains; however, they are more disabling than lateral ankle sprains. The reported incidence of isolated syndesmosis injuries in acute ankle sprains ranges between 1% and 16%. When ankle disability lasts for more than 2 months after an ankle sprain, the incidence increases to 23.6%. Diagnostic workup may include stress radiographs, magnetic resonance imaging, or diagnostic arthroscopy. A simple stress test radiograph may reveal an unstable grade III syndesmosis sprain that may go unrecognized on plain anteroposterior and mortise or lateral radiographs of the ankle. The duration of symptoms in isolated syndesmosis injury is longer and more severe, often leading to chronic symptoms or ankle instability requiring operative stabilization.This article describes the clinical presentation, injury classification, and operative stabilization techniques of isolated syndesmosis injuries. The authors performed their preferred operative stabilization technique for isolated syndesmosis injury-arthroscopic debridement of the ankle with syndesmotic stabilization with a syndesmotic screw-in 4 patients. All patients were evaluated 1 year postoperatively with subjective and objective assessment scales. Three of 4 patients showed good improvement of general subjective ankle symptoms and subjective ankle instability rating and a high Sports Ankle Rating System score after 1 year. Copyright 2012, SLACK Incorporated.

The efficacy of a supervised and a home-based core strengthening programme in adults with poor core stability: a three-arm randomised controlled trial.

PubMed

Chuter, V H; de Jonge, X A K Janse; Thompson, B M; Callister, R

2015-03-01

Poor core stability is linked to a range of musculoskeletal pathologies and core-strengthening programmes are widely used as treatment. Treatment outcomes, however, are highly variable, which may be related to the method of delivery of core strengthening programmes. We investigated the effect of identical 8 week core strengthening programmes delivered as either supervised or home-based on measures of core stability. Participants with poor core stability were randomised into three groups: supervised (n=26), home-based (n=26) or control (n=26). Primary outcomes were the Sahrmann test and the Star Excursion Balance Test (SEBT) for dynamic core stability and three endurance tests (side-bridge, flexor and Sorensen) for static core stability. The exercise programme was devised and supervised by an exercise physiologist. Analysis of covariance on the change from baseline over the 8 weeks showed that the supervised group performed significantly better on all core stability measures than both the home-based and control group. The home-based group produced significant improvements compared to the control group in all static core stability tests, but not in most of the dynamic core stability tests (Sahrmann test and two out of three directions of the SEBT). Our results support the use of a supervised core-strengthening programme over a home-based programme to maximise improvements in core stability, especially in its dynamic aspects. Based on our findings in healthy individuals with low core stability, further research is recommended on potential therapeutic benefits of supervised core-strengthening programmes for pathologies associated with low core stability. ACTRN12613000233729. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

International Council for Standardization in Haematology (ICSH) Recommendations for Laboratory Measurement of Direct Oral Anticoagulants.

PubMed

Gosselin, Robert C; Adcock, Dorothy M; Bates, Shannon M; Douxfils, Jonathan; Favaloro, Emmanuel J; Gouin-Thibault, Isabelle; Guillermo, Cecilia; Kawai, Yohko; Lindhoff-Last, Edelgard; Kitchen, Steve

2018-03-01

This guidance document was prepared on behalf of the International Council for Standardization in Haematology (ICSH) for providing haemostasis-related guidance documents for clinical laboratories. This inaugural coagulation ICSH document was developed by an ad hoc committee, comprised of international clinical and laboratory direct acting oral anticoagulant (DOAC) experts. The committee developed consensus recommendations for laboratory measurement of DOACs (dabigatran, rivaroxaban, apixaban and edoxaban), which would be germane for laboratories assessing DOAC anticoagulation. This guidance document addresses all phases of laboratory DOAC measurements, including pre-analytical (e.g. preferred time sample collection, preferred sample type, sample stability), analytical (gold standard method, screening and quantifying methods) and post analytical (e.g. reporting units, quality assurance). The committee addressed the use and limitations of screening tests such as prothrombin time, activated partial thromboplastin time as well as viscoelastic measurements of clotting blood and point of care methods. Additionally, the committee provided recommendations for the proper validation or verification of performance of laboratory assays prior to implementation for clinical use, and external quality assurance to provide continuous assessment of testing and reporting method. Schattauer GmbH Stuttgart.

Affective temperaments and suicidal ideation and behavior in mood and anxiety disorder patients.

PubMed

Baldessarini, Ross J; Vázquez, Gustavo H; Tondo, Leonardo

2016-07-01

Clinical characteristics proposed to be associated with suicidal risk include affective temperament types. We tested this proposal with two methods in a large sample of subjects with mood and anxiety disorders. We assessed consecutive, consenting subjects clinically for affective temperament types and by TEMPS-A self-ratings for associations of temperament with suicidal ideation and acts, using standard bivariate methods, and multivariate logistic regression models. Among 2561 subjects (major depressive, 1171; bipolar, 919, anxiety disorders, 471), temperament-types and TEMPS-A (39-item Italian version) subscale scores differed by risk of suicidal acts or ideation. Suicidal acts and ideation were most associated with cyclothymic and dysthymic, and less with hyperthymic temperaments. These associations were sustained by multivariate modeling that included diagnosis, age, sex, and diagnosis. Not all subjects completed TEMPS-A self-ratings; clinical assessments of temperaments were not standardized, and long-term stability of temperament assessments was not tested. The findings support and extend associations of cyclothymic-dysthymic temperaments with suicidal acts and ideation, whereas hyperthymic temperament may be protective. Copyright © 2016 Elsevier B.V. All rights reserved.

Comparison of Fecal Collection Methods for Microbiota Studies in Bangladesh

PubMed Central

Chen, Jun; Kibriya, Muhammad G.; Chen, Yu; Islam, Tariqul; Eunes, Mahbubul; Ahmed, Alauddin; Naher, Jabun; Rahman, Anisur; Amir, Amnon; Shi, Jianxin; Abnet, Christian C.; Nelson, Heidi; Knight, Rob; Chia, Nicholas; Ahsan, Habibul; Sinha, Rashmi

2017-01-01

ABSTRACT To our knowledge, fecal microbiota collection methods have not been evaluated in low- and middle-income countries. Therefore, we evaluated five different fecal sample collection methods for technical reproducibility, stability, and accuracy within the Health Effects of Arsenic Longitudinal Study (HEALS) in Bangladesh. Fifty participants from the HEALS provided fecal samples in the clinic which were aliquoted into no solution, 95% ethanol, RNAlater, postdevelopment fecal occult blood test (FOBT) cards, and fecal immunochemical test (FIT) tubes. Half of the aliquots were frozen immediately at −80°C (day 0) and the remaining samples were left at ambient temperature for 96 h and then frozen (day 4). Intraclass correlation coefficients (ICC) were calculated for the relative abundances of the top three phyla, for two alpha diversity measures, and for four beta diversity measures. The duplicate samples had relatively high ICCs for technical reproducibility at day 0 and day 4 (range, 0.79 to 0.99). The FOBT card and samples preserved in RNAlater and 95% ethanol had the highest ICCs for stability over 4 days. The FIT tube had lower stability measures overall. In comparison to the “gold standard” method using immediately frozen fecal samples with no solution, the ICCs for many of the microbial metrics were low, but the rank order appeared to be preserved as seen by the Spearman correlation. The FOBT cards, 95% ethanol, and RNAlater were effective fecal preservatives. These fecal collection methods are optimal for future cohort studies, particularly in low- and middle-income countries. IMPORTANCE The collection of fecal samples in prospective cohort studies is essential to provide the opportunity to study the effect of the human microbiota on numerous health conditions. However, these collection methods have not been adequately tested in low- and middle-income countries. We present estimates of technical reproducibility, stability at ambient temperature for 4 days, and accuracy comparing a “gold standard” for fecal samples in no solution, 95% ethanol, RNAlater, postdevelopment fecal occult blood test cards, and fecal immunochemical test tubes in a study conducted in Bangladesh. Fecal occult blood test cards and fecal samples stored in 95% ethanol or RNAlater adequately preserve fecal samples in this setting. Therefore, new studies in low- and middle-income countries should include collection of fecal samples using fecal occult blood test cards, 95% ethanol, or RNAlater for prospective cohort studies. PMID:28258145

The characterisation of next generation ceramic bearings for orthopaedic hip applications

NASA Astrophysics Data System (ADS)

Insley, Gerard M.

Two zirconia toughened alumina ceramic materials were characterised for application as bearing surfaces for hip joint arthroplasty. Both ceramics were supplied by orthopaedic ceramic suppliers in the form of flat discs, flexural strength bars and finished ball heads and cups. Analysis techniques involved standard and novel test methods in order to gauge the suitability of the ZTA for this application. These included mechanical strength testing, phase composition analysis by x-ray diffraction, accelerated and real time stability testing, friction testing and hip simulator testing under standard and nonstandard conditions. Alumina was used as a control in all testing. The results show the ZTA materials to be 50 to 75% stronger and up to 25% tougher than the alumina. Both materials differ in terms of their processing, microstructure and crystalline phase composition, however both showed no tetragonal to monoclinic degradation after both accelerated and real time ageing. The friction and wear tests show the ZTA to be performing as well as the alumina in normal test conditions. However, when microseparation is introduced into the hip simulator testing the ZTA ceramics wear significantly less than the alumina. Clinical analysis of a series of explanted heads showed that microseparation definitely occurs in the clinical situation with wear scars observed in eleven out of sixteen components. Zirconia toughened alumina is suitable as a fourth generation bearing surface for hip joint arthroplasty.

Optimization of the decision-making process for the selection of therapeutics to undergo clinical testing for spinal cord injury in the North American Clinical Trials Network.

PubMed

Guest, James; Harrop, James S; Aarabi, Bizhan; Grossman, Robert G; Fawcett, James W; Fehlings, Michael G; Tator, Charles H

2012-09-01

The North American Clinical Trials Network (NACTN) includes 9 clinical centers funded by the US Department of Defense and the Christopher Reeve Paralysis Foundation. Its purpose is to accelerate clinical testing of promising therapeutics in spinal cord injury (SCI) through the development of a robust interactive infrastructure. This structure includes key committees that serve to provide longitudinal guidance to the Network. These committees include the Executive, Data Management, and Neurological Outcome Assessments Committees, and the Therapeutic Selection Committee (TSC), which is the subject of this manuscript. The NACTN brings unique elements to the SCI field. The Network's stability is not restricted to a single clinical trial. Network members have diverse expertise and include experts in clinical care, clinical trial design and methodology, pharmacology, preclinical and clinical research, and advanced rehabilitation techniques. Frequent systematic communication is assigned a high value, as is democratic process, fairness and efficiency of decision making, and resource allocation. This article focuses on how decision making occurs within the TSC to rank alternative therapeutics according to 2 main variables: quality of the preclinical data set, and fit with the Network's aims and capabilities. This selection process is important because if the Network's resources are committed to a therapeutic, alternatives cannot be pursued. A proposed methodology includes a multicriteria decision analysis that uses a Multi-Attribute Global Inference of Quality matrix to quantify the process. To rank therapeutics, the TSC uses a series of consensus steps designed to reduce individual and group bias and limit subjectivity. Given the difficulties encountered by industry in completing clinical trials in SCI, stable collaborative not-for-profit consortia, such as the NACTN, may be essential to clinical progress in SCI. The evolution of the NACTN also offers substantial opportunity to refine decision making and group dynamics. Making the best possible decisions concerning therapeutics selection for trial testing is a cornerstone of the Network's function.

Reliability of the "Ten Test" for assessment of discriminative sensation in hand trauma.

PubMed

Berger, Michael J; Regan, William R; Seal, Alex; Bristol, Sean G

2016-10-01

"Ten Test" (TT) is a bedside measure of discriminative sensation, whereby the magnitude of abnormal sensation to moving light touch is normalized to an area of normal sensation on an 11-point Likert scale (0-10). The purposes of this study were to determine reliability parameters of the TT in a cohort of patients presenting to a hand trauma clinic with subjectively altered sensation post-injury and to compare the reliability of TT to that of the Weinstein Enhanced Sensory Test (WEST). Study participants (n = 29, mean age = 37 ± 12) comprised patients presenting to an outpatient hand trauma clinic with recent hand trauma and self reported abnormal sensation. Participants underwent TT and WEST by two separate raters on the same day. Interrater reliability, response stability and responsiveness of each test were determined by the intraclass correlation coefficient (ICC: 2, 1), standard error of measurement (SEM) with 95% confidence intervals (CI) and minimal detectable difference score, with 95% CI (MDD95), respectively. The TT displayed excellent interrater reliability (ICC = 0.95, 95% CI 0.89-0.97) compared to good reliability for WEST (ICC = 0.78, 95% CI 0.58-0.89). The range of true scores expected with 95% confidence based on the SEM (i.e. response stability), was ±1.1 for TT and ±1.1 for WEST. MDD95 scores reflecting test responsiveness were 1.5 and 1.6 for TT and WEST, respectively. The TT displayed excellent reliability parameters in this patient population. Reliability parameters were stronger for TT compared to WEST. These results provide support for the use of TT as a component of the sensory exam in hand trauma. Copyright © 2016 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

Some Static Oscillatory and Free Body Tests of Blunt Bodies at Low Subsonic Speeds

NASA Technical Reports Server (NTRS)

Lichtenstein, Jacob H.; Fisher, Lewis R.; Scher, Stanley H.; Lawrence, George F.

1959-01-01

Some blunt-body shapes considered suitable for entry into the earth's atmosphere were tested by both static and oscillatory methods in the Langley stability tunnel. In addition, free-fall tests of some similar models were made in the Langley 20-foot free-spinning tunnel. The results of the tests show that increasing the flare of the body shape increased the dynamic stability and that for flat-faced shapes increasing the corner radius increased the stability. The test data from the Langley stability tunnel were used to compute the damping factor for the models tested in the langley 20-foot free-spinning tunnel. For these cases in which the damping factor was low, -1/2 or less, the stability was critical and sensitive to disturbance. When the damping factor was about -2, damping was generally obtained.

Laboratory evaluation of the pointing stability of the ASPS Vernier System

NASA Technical Reports Server (NTRS)

1980-01-01

The annular suspension and pointing system (ASPS) is an end-mount experiment pointing system designed for use in the space shuttle. The results of the ASPS Vernier System (AVS) pointing stability tests conducted in a laboratory environment are documented. A simulated zero-G suspension was used to support the test payload in the laboratory. The AVS and the suspension were modelled and incorporated into a simulation of the laboratory test. Error sources were identified and pointing stability sensitivities were determined via simulation. Statistical predictions of laboratory test performance were derived and compared to actual laboratory test results. The predicted mean pointing stability during simulated shuttle disturbances was 1.22 arc seconds; the actual mean laboratory test pointing stability was 1.36 arc seconds. The successful prediction of laboratory test results provides increased confidence in the analytical understanding of the AVS magnetic bearing technology and allows confident prediction of in-flight performance. Computer simulations of ASPS, operating in the shuttle disturbance environment, predict in-flight pointing stability errors less than 0.01 arc seconds.

A Wearable Proprioceptive Stabilizer (Equistasi®) for Rehabilitation of Postural Instability in Parkinson’s Disease: A Phase II Randomized Double-Blind, Double-Dummy, Controlled Study

PubMed Central

Volpe, Daniele; Giantin, Maria Giulia; Fasano, Alfonso

2014-01-01

Background Muscle spindles endings are extremely sensitive to externally applied vibrations, and under such circumstances they convey proprioceptive inflows to the central nervous system that modulate the spinal reflexes excitability or the muscle responses elicited by postural perturbations. The aim of this pilot study is to test the feasibility and effectiveness of a balance training program in association with a wearable proprioceptive stabilizer (Equistasi) that emits focal mechanical vibrations in patients with PD. Methods Forty patients with PD were randomly divided in two groups wearing an active or inactive device. All the patients received a 2-month intensive program of balance training. Assessments were performed at baseline, after the rehabilitation period (T1), and two more months after (T2). Posturographic measures were used as primary endpoint; secondary measures of outcome included the number of falls and several clinical scales for balance and quality of life. Results Both groups improved at the end of the rehabilitation period and we did not find significant between-group differences in any of the principal posturographic measures with the exception of higher sway area and limit of stability on the instrumental functional reach test during visual deprivation at T1 in the Equistasi group. As for the secondary outcome, we found an overall better outcome in patients enrolled in the Equistasi group: 1) significant improvement at T1 on Berg Balance Scale (+45.0%, p = .026), Activities-specific Balance Confidence (+83.7, p = .004), Falls Efficacy Scale (−33.3%, p = .026) and PDQ-39 (−48.8%, p = .004); 2) sustained improvement at T2 in terms of UPDRS-III, Berg Balance Scales, Time Up and Go and PDQ-39; 3) significant and sustained reduction of the falls rate. Conclusions This pilot trial shows that a physiotherapy program for training balance in association with focal mechanical vibration exerted by a wearable proprioceptive stabilizer might be superior than rehabilitation alone in improving patients’ balance. Trial Registration EudraCT 2013-003020-36 and ClinicalTrials.gov (number not assigned) PMID:25401967

Longitudinal stability of the diurnal rhythm of intraocular pressure in subjects with healthy eyes, ocular hypertension and pigment dispersion syndrome.

PubMed

Huchzermeyer, Cord; Reulbach, Udo; Horn, Folkert; Lämmer, Robert; Mardin, Christian Y; Jünemann, Anselm G M

2014-10-15

The diurnal fluctuation of intraocular pressure may be relevant in glaucoma. The aim of this study was to find out whether the timing of diurnal fluctuation is stable over the years. Long-term IOP data from the Erlangen Glaucoma Registry, consisting of several annual extended diurnal IOP profiles for each patient, was retrospectively analyzed. Normal subjects, patients with ocular hypertension and with pigment dispersion syndrome were included because these subjects had not been treated with antiglaucomatous medications at the time of data acquisition. A cosine curve was fitted to the IOP data and the stability of individual rhythms over the years was tested using the Rayleigh test. To compare the peak times among groups, means were calculated only from subjects with a significant Rayleigh test. Of the fifty-two eligible subjects, a total of 364 extended diurnal IOP profiles measured in a sitting position had been collected over a period of 114 ± 39 months. The Rayleigh test indicated intraindividual stability of phase timing only in 19 subjects (36%). In subjects with pigment dispersions syndrome, peak IOP occurred on average two hours and seven minutes later during the day compared with subjects without this condition (p = 0.05). Fitting of cosine curves to the clinical IOP profiles was generally feasible, although careful interpretation is warranted due to lack of measurements in supine position and between midnight and 7 am. The interesting observation of a phase lag in eyes with pigment dispersion syndrome warrants confirmation and exploration in future prospective studies. The analysis of the IOP data showed no stable individual rhythm in the long term in a majority of patients.

Test-Retest Stability of the Task and Ego Orientation Questionnaire

ERIC Educational Resources Information Center

Lane, Andrew M.; Nevill, Alan M.; Bowes, Neal; Fox, Kenneth R.

2005-01-01

Establishing stability, defined as observing minimal measurement error in a test-retest assessment, is vital to validating psychometric tools. Correlational methods, such as Pearson product-moment, intraclass, and kappa are tests of association or consistency, whereas stability or reproducibility (regarded here as synonymous) assesses the…

A functional murine model of hindlimb demand ischemia.

PubMed

Peck, Michael A; Crawford, Robert S; Abularrage, Christopher J; Patel, Virendra I; Conrad, Mark F; Yoo, Jin Hyung; Watkins, Michael T; Albadawi, Hassan

2010-05-01

To date, murine models of treadmill exercise have been used to study general exercise physiology and angiogenesis in ischemic hindlimbs. The purpose of these experiments was to develop a murine model of demand ischemia in an ischemic limb to mimic claudication in humans. The primary goal was to determine whether treadmill exercise reflected a hemodynamic picture which might be consistent with the hyperemic response observed in humans. Aged hypercholesterolemic ApoE null mice (ApoE(-/-), n = 13) were subjected to femoral artery ligation (FAL) and allowed to recover from the acute ischemic response. Peripheral perfusion of the hindlimbs at rest was determined by serial evaluation using laser Doppler imaging (LDI) on days 0, 7, and 14 following FAL. During the experiments, mice were also assessed on an established five-point clinical ischemic score, which assessed the degree of digital amputation, necrosis, and cyanosis compared to the nonischemic contralateral limb. After stabilization of the LDI ratio (ischemic limb flux/contralateral nonischemic limb flux) and clinical ischemic score, mice underwent 2 days of treadmill training (10 min at 10 m/min, incline of 10 degrees ) followed by 60 min of daily treadmill exercise (13 m/min, incline of 10 degrees ) through day 25. An evaluation of preexercise and postexercise perfusion using LDI was performed on two separate occasions following the onset of daily exercise. During the immediate 15 min postexercise evaluation, LDI scanning was obtained in quadruplicate, to allow identification of peak flux ratios. Statistical analysis included unpaired t-tests and analysis of variance. After FAL, the LDI flux ratio reached a nadir between days 1 and 2, then stabilized by day 14 and remained stable through day 25. The clinical ischemic score stabilized at day 7 and remained stable throughout the rest of the experiment. Based on stabilization of both the clinical ischemic score and LDI ratio, exercise training began on day 15. The peak 15 min postexercise LDI ratio increased significantly compared to the preexercise ratio on day 17 (0.48 +/- 0.04 vs. 0.34 +/- 0.04, p < 0.05) and day 25 (0.37 +/- 0.03 vs. 0.27 +/- 0.03, p < 0.01). Within 2 hr of exercise, the LDI ratio returned to preexercise levels on both days 17 and 25. Clinical and hemodynamic stabilization of limb perfusion is evident by 14 days after FAL. FAL followed by demand ischemia results in a reversible relative hyperemic response similar to that observed in exercising human claudicants. A murine model of FAL associated with demand ischemia may be useful to evaluate the metabolic, inflammatory, and flow-related changes associated with claudication in humans. Copyright 2010 Annals of Vascular Surgery Inc. All rights reserved.

Mutagencity Testing of WR238605 Succinate

DTIC Science & Technology

1996-05-03

control article have not been determined by the testing facility. The stability of the test or control article under the test conditions has not been...determined by the testing facility and is not included in the final report. Analyses to determine the uniformity, concentration, or stability of the...fraction. Aliquots of the dosing solutions have been retained by MA. The Sponsor has assumed responsibility for the determination of the stability

Clinical application of the Panjabi neutral zone hypothesis: the Stabilimax NZ posterior lumbar dynamic stabilization system.

PubMed

Yue, James J; Timm, Jens P; Panjabi, Manohar M; Jaramillo-de la Torre, Jorge

2007-01-15

The neutral zone (NZ) is a region of intervertebral motion around the neutral posture where little resistance is offered by the passive spinal column. The NZ appears to be a clinically important measure of spinal stability function. Its size may increase with injury to the spinal column, which in turn may result in spinal instability or low-back pain. Dynamic stabilization systems are designed to support and stabilize the spine while maintaining range of motion (ROM). The Stabilimax NZ device has been designed to reduce the NZ after spinal injury to treat pain while preserving ROM.

Stability of Beriplast P fibrin sealant: storage and reconstitution.

PubMed

Eberhard, Ulrich; Broder, Martin; Witzke, Günther

2006-04-26

This study was performed to investigate the stability of Beriplast P fibrin sealant (FS) across a range of storage conditions, both pre- and post-reconstitution. Storage stability of the FS was evaluated during long-term refrigeration (24 months) with or without interim storage at elevated temperatures (40 degrees C for 1 week and 25 degrees C for 1 and 3 months). Stability of individual FS components was assessed by measuring: fibrinogen content, Factor XIII activity (FXIII), thrombin activity and aprotinin potency. The package integrity of each component was also checked (sterility testing, moisture content and pH). Storage stability was also evaluated by testing the reconstituted product for adhesion (tearing force testing after mixing the solutions) and sterility. Reconstitution stability was evaluated following 3-months' storage, for up to 50 h post-reconstitution using the same tests as for the storage stability investigations. Pre-defined specifications were met for fibrinogen content, Factor XIII activity, and thrombin activity, demonstrating storage stability. Package integrity and the functionality and sterility of the reconstituted product were confirmed throughout. Reconstitution stability was demonstrated for up to 50 h following reconstitution, in terms of both tearing force and sterility tests. In conclusion, the storage stability of Beriplast P was demonstrated over a range of 24-month storage schedules including interim exposure to elevated temperature, and the reconstituted product was stable for up to 50 h.

Duration of untreated illness and suicide in bipolar disorder: a naturalistic study.

PubMed

Altamura, A Carlo; Dell'Osso, Bernardo; Berlin, Heather A; Buoli, Massimiliano; Bassetti, Roberta; Mundo, Emanuela

2010-08-01

The aim of this naturalistic study was to evaluate the potential influence of the duration of untreated illness (DUI)--defined as the time elapsed between the occurrence of the first mood episode and the first adequate pharmacological treatment with mood stabilizers--on the clinical course of bipolar disorder (BD). Three hundred and twenty outpatients (n = 320) with a DSM-IV diagnosis of BD--either Type I or Type II--were interviewed; their clinical features were collected and they were naturalistically followed-up for 5 years. At the end of the follow-up observation, the sample was subdivided into two groups: one group with a DUI < or =2 years (n = 65) and another group with a DUI >2 years (n = 255). The main demographic and clinical variables were analyzed and compared between the two subgroups of patients using chi-square tests for dichotomous variables or Mann-Whitney U tests for continuous variables. Patients with a longer DUI showed a higher frequency of suicide attempts (Z = -2.11, P = 0.035), a higher number of suicide attempters (chi(2) = 4.13, df = 1, P = 0.04), and a longer duration of illness (Z = -6.79, P < 0.0001) when compared to patients with a shorter DUI. Moreover, patients with a longer DUI had a depressive first episode more frequently than patients with a shorter DUI (chi(2) = 11.28, df = 2, P = 0.004). A further analysis performed dividing the total sample into two subgroups on the basis of a DUI of 6 years (corresponding to the median value of the DUI in the study sample) confirmed prior findings. Results indicate a potential association between a longer DUI and a worse outcome in BD, particularly in terms of suicidality, and confirm the clinical relevance of early diagnosis and pharmacological intervention with mood stabilizers in BD.

Reliability of kinetic visual field testing in children with mutation-proven retinal dystrophies: Implications for therapeutic clinical trials.

PubMed

Dedania, Vaidehi S; Liu, Jerry Y; Schlegel, Dana; Andrews, Chris A; Branham, Kari; Khan, Naheed W; Musch, David C; Heckenlively, John R; Jayasundera, K Thiran

2018-01-01

Kinetic visual field testing is used to monitor disease course in retinal dystrophy clinical care and treatment response in treatment trials, which are increasingly recruiting children. This study investigates Goldmann visual field (GVF) changes in young children with mutation-proven retinal dystrophies as they age and with progression of the retinal degeneration. Retrospective review of children ≤ 17 years old with a mutation-proven retinal dystrophy. Objective clinical disease activity was assessed by a retinal degeneration specialist masked to GVF results. Digital quantification of GVF area was performed. Twenty-nine children (58 eyes), ages 5-16, were identified. GVF area increased with age despite progression in 20 children and clinical stability in nine children. Mean ± standard error increase in GVF area/year was 333 ± 130 mm 2 (I4e, p = 0.012), 720 ± 155 mm 2 (III4e, p < 0.001), and 759 ± 167 mm 2 (IV4e, p < 0.001), with greater increases at earlier ages. Repeatability coefficients were 7381 mm 2 (I4e), 9379 mm 2 (III4e), and 10346 mm 2 (IV4e), indicating a large variability. At 2.5 years after the baseline GVF the area increased ≥ 20%, the criterion for positive treatment outcome defined in recent published therapeutic trials, in 38% (I4e), 34% (III4e), and 33% (IV4e) of eyes. In a substantial proportion of children with mutation-proven retinal dystrophies, there is a significant increase in GVF area with age, particularly those < 12 years, despite progression or stability of disease. These findings suggest that change in GVF area in children with retinal dystrophies can be an unreliable measure of response to treatment and on which to base appropriate counseling about visual impairment.

The development and reliability of a simple field based screening tool to assess core stability in athletes.

PubMed

O'Connor, S; McCaffrey, N; Whyte, E; Moran, K

2016-07-01

To adapt the trunk stability test to facilitate further sub-classification of higher levels of core stability in athletes for use as a screening tool. To establish the inter-tester and intra-tester reliability of this adapted core stability test. Reliability study. Collegiate athletic therapy facilities. Fifteen physically active male subjects (19.46 ± 0.63) free from any orthopaedic or neurological disorders were recruited from a convenience sample of collegiate students. The intraclass correlation coefficients (ICC) and 95% Confidence Intervals (CI) were computed to establish inter-tester and intra-tester reliability. Excellent ICC values were observed in the adapted core stability test for inter-tester reliability (0.97) and good to excellent intra-tester reliability (0.73-0.90). While the 95% CI were narrow for inter-tester reliability, Tester A and C 95% CI's were widely distributed compared to Tester B. The adapted core stability test developed in this study is a quick and simple field based test to administer that can further subdivide athletes with high levels of core stability. The test demonstrated high inter-tester and intra-tester reliability. Copyright © 2015 Elsevier Ltd. All rights reserved.

77 FR 58999 - Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-25

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0938] Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug Substances... their complexity, the FDA is considering standardizing stability testing policies by adopting...

Impacts of small vestibular schwannoma on community ambulation, postural, and ocular control.

PubMed

Low Choy, Nancy L; Lucey, Mary-Therese M; Lewandowski, Susan L; Panizza, Benedict J

2017-05-01

To investigate balance, community mobility, gaze instability, and dizziness handicap and assess falls risk in people who are conservatively managed with small vestibular schwannoma (VS). Cross-sectional study with controls. The study involved 18 people (mean age 58.7 ± 12.2 years) diagnosed with VS (<12 mm) and 22 age-matched controls (mean age 56.9 ± 8.0 years). Measures included standing on firm and foam surfaces with feet apart, then together with eyes open and closed, Timed Up and Go (TUG) test and dual TUG test, Dynamic Gait Index, 6-Minute Walk Test, Halmagyi Impulse Test, Dynamic Visual Acuity Test, and the Dizziness Handicap Inventory. The clinical group failed more trials standing feet together on foam with eyes closed (P < .05); had inferior mobility and walked more slowly with divided attention (P < .05); had more difficulty walking with head movement, negotiating obstacles, and using stairs (P < .01); and walked shorter distances (P < .001) than controls. Reduced gaze stability (P < .01) and higher total (P = .007) and subcategory dizziness handicap scores (P < .05) were revealed compared to age-matched controls. Although outcomes for the clinical group are inferior to the control group across all measures and the dizziness impact is higher, the results fall in the low-risk category for falls. Preliminary data (level 4 evidence) support using a suite of clinical measures to monitor people with VS during conservative management. 4 Laryngoscope, 127:1147-1152, 2017. © 2016 The American Laryngological, Rhinological and Otological Society, Inc.

Collateral ligament strains during knee joint laxity evaluation before and after TKA.

PubMed

Delport, Hendrik; Labey, Luc; De Corte, Ronny; Innocenti, Bernardo; Vander Sloten, Jos; Bellemans, Johan

2013-08-01

Passive knee stability is provided by the soft tissue envelope. There is consensus among orthopedic surgeons that good outcome in Total Knee Arthroplasty requires equal tension in the medial/lateral compartment of the knee joint, as well as equal tension in the flexion/extension gap. The purpose of this study was to quantify the ligament laxity in the normal non-arthritic knee before and after Posterior-Stabilized Total Knee Arthroplasty. We hypothesized that the Medial/Lateral Collateral Ligament shows minimal changes in length when measured directly by extensometers in the native human knee during varus/valgus laxity testing. We also hypothesized that due to differences in material properties and surface geometry, native laxity is difficult to reconstruct using a Posterior-Stabilized Total Knee. Six specimens were used to perform this in vitro cadaver test using extensometers to provide numerical values for laxity and varus-valgus tilting in the frontal plane. This study enabled a precise measurement of varus-valgus laxity as compared with the clinical assessment. The strains in both ligaments in the replaced knee were different from those in the native knee. Both ligaments were stretched in extension, in flexion the Medial Collateral Ligament tends to relax and the Lateral Collateral Ligament remains tight. As material properties and surface geometry of the replaced knee add stiffness to the joint, we recommend to avoid overstuffing the joint, when using this type of Posterior-Stabilized Total Knee Arthroplasty, in order to obtain varus/valgus laxity close to the native joint. Copyright © 2013 Elsevier Ltd. All rights reserved.

First external quality assurance program for bloodstream Real-Time PCR monitoring of treatment response in clinical trials of Chagas disease.

PubMed

Ramírez, Juan C; Parrado, Rudy; Sulleiro, Elena; de la Barra, Anabelle; Rodríguez, Marcelo; Villarroel, Sandro; Irazu, Lucía; Alonso-Vega, Cristina; Alves, Fabiana; Curto, María A; García, Lineth; Ortiz, Lourdes; Torrico, Faustino; Gascón, Joaquim; Flevaud, Laurence; Molina, Israel; Ribeiro, Isabela; Schijman, Alejandro G

2017-01-01

Real-Time PCR (qPCR) testing is recommended as both a diagnostic and outcome measurement of etiological treatment in clinical practice and clinical trials of Chagas disease (CD), but no external quality assurance (EQA) program provides performance assessment of the assays in use. We implemented an EQA system to evaluate the performance of molecular biology laboratories involved in qPCR based follow-up in clinical trials of CD. An EQA program was devised for three clinical trials of CD: the E1224 (NCT01489228), a pro-drug of ravuconazole; the Sampling Study (NCT01678599), that used benznidazole, both conducted in Bolivia; and the CHAGASAZOL (NCT01162967), that tested posaconazole, conducted in Spain. Four proficiency testing panels containing negative controls and seronegative blood samples spiked with 1, 10 and 100 parasite equivalents (par. eq.)/mL of four Trypanosoma cruzi stocks, were sent from the Core Lab in Argentina to the participating laboratories located in Bolivia and Spain. Panels were analyzed simultaneously, blinded to sample allocation, at 4-month intervals. In addition, 302 random blood samples from both trials carried out in Bolivia were sent to Core Lab for retesting analysis. The analysis of proficiency testing panels gave 100% of accordance (within laboratory agreement) and concordance (between laboratory agreement) for all T. cruzi stocks at 100 par. eq./mL; whereas their values ranged from 71 to 100% and from 62 to 100% at 1 and 10 par. eq./mL, respectively, depending on the T. cruzi stock. The results obtained after twelve months of preparation confirmed the stability of blood samples in guanidine-EDTA buffer. No significant differences were found between qPCR results from Bolivian laboratory and Core Lab for retested clinical samples. This EQA program for qPCR analysis of CD patient samples may significantly contribute to ensuring the quality of laboratory data generated in clinical trials and molecular diagnostics laboratories of CD.

Development of a socket-type rib coaptation device made of poly-L-lactide fibers: feasibility study in a canine model

PubMed Central

Komatsu, Teruya; Sakaguchi, Yasuto; Muranishi, Yusuke; Yutaka, Yojiro; Date, Hiroshi; Nakamura, Tatsuo

2018-01-01

Background Costal coaptation pins made of poly-L-lactide (PLA) are clinically available for fixing surgically divided ribs. However, the clinical results of such rib fixation have not been completely satisfactory. We aimed to develop a new rib coaptation socket system and explore its clinical applicability. Methods We surgically divided three consecutive ribs of each beagle dog, and rib coaptation sockets were implanted to stabilize each rib. Fifteen 3-dimensional (3D)-printed and 30 PLA fiber knitted sockets were implanted in five and ten dogs, respectively, to stabilize the artificially divided ribs. Mechanical analysis of the sockets and radiographical examination of costal fixation were performed to evaluate the effectiveness of the newly developed socket system for rib stabilization. Results All 15 ribs with 3D-printed sockets had displaced 1 month after the operation. Three ribs in one dog with implanted PLA fiber knitted sockets were displaced radiographically after 1 month, and the grade of displacement remained unchanged after 6 months. The remaining 27 ribs fixed with PLA fiber knitted sockets did not show any displacement. Conclusions The PLA fiber knitted rib coaptation socket system was sufficiently durable for the stabilization of divided ribs with biocompatibility. This promising finding can be applied for clinical stabilization of divided ribs. PMID:29850125

Development of a socket-type rib coaptation device made of poly-L-lactide fibers: feasibility study in a canine model.

PubMed

Komatsu, Teruya; Sato, Toshihiko; Sakaguchi, Yasuto; Muranishi, Yusuke; Yutaka, Yojiro; Date, Hiroshi; Nakamura, Tatsuo

2018-04-01

Costal coaptation pins made of poly-L-lactide (PLA) are clinically available for fixing surgically divided ribs. However, the clinical results of such rib fixation have not been completely satisfactory. We aimed to develop a new rib coaptation socket system and explore its clinical applicability. We surgically divided three consecutive ribs of each beagle dog, and rib coaptation sockets were implanted to stabilize each rib. Fifteen 3-dimensional (3D)-printed and 30 PLA fiber knitted sockets were implanted in five and ten dogs, respectively, to stabilize the artificially divided ribs. Mechanical analysis of the sockets and radiographical examination of costal fixation were performed to evaluate the effectiveness of the newly developed socket system for rib stabilization. All 15 ribs with 3D-printed sockets had displaced 1 month after the operation. Three ribs in one dog with implanted PLA fiber knitted sockets were displaced radiographically after 1 month, and the grade of displacement remained unchanged after 6 months. The remaining 27 ribs fixed with PLA fiber knitted sockets did not show any displacement. The PLA fiber knitted rib coaptation socket system was sufficiently durable for the stabilization of divided ribs with biocompatibility. This promising finding can be applied for clinical stabilization of divided ribs.

Influence of denture adhesives on occlusion and disocclusion times.

PubMed

Abdelnabi, Mohamed Hussein; Swelem, Amal Ali; Al-Dharrab, Ayman A

2016-03-01

The effectiveness of adhesives in enhancing several functional aspects of complete denture performance has been well established. The direct influence of adhesives on occlusal contact simultaneity has not yet been investigated. The purpose of this crossover clinical trial was to evaluate quantitatively the influence of adhesives on occlusal balance by recording timed occlusal contacts; namely occlusion time (OT) and disocclusion time during right (DT-right) and left (DT-left) excursions by using computerized occlusal analysis. A crossover clinical trial was adopted. Assessments were carried out while participants (n=49) wore their dentures first without then with adhesives. Computerized occlusal analysis using the T-Scan III system was conducted to perform baseline computer-guided occlusal adjustment for conventionally fabricated dentures. Retention and stability assessment using the modified Kapur index and recording of OT and DT-right and DT-left values using the T-Scan III were subsequently carried out for all dentures, first without adhesives and then after application of adhesive. All T-Scan procedures were carried out by the same clinician. Wilcoxon signed-rank test was used to analyze the Kapur index scores and occlusal parameters (α=.05). Stability and retention of conventional dentures ranged initially from good to very good. However, adhesive application resulted in significant improvement (P<.001) in stability and retention and a significant decrease in duration of all occlusal parameters (OT [P=.003], DT-right [P=.003], and DT-left [P=.008]). Adhesives significantly decreased OT and DT durations in initially well-fitting complete dentures with fairly well balanced occlusion, and further enhanced denture stability and occlusal contact simultaneity. Copyright © 2016 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

Development of Special Biological Products

DTIC Science & Technology

1981-01-01

Rocky Mountain Spotted Fever (RMSF) 20. Continued B. Tissue Culture / ?Two production lots of FRhL-2 dnd three of MRC-5 were stabilized...104) was potency tested. J. Q Fever Vaccine Storage Stability Potency Testing Q fever vaccine (NDBR 105) was put on potency test. K. Rocky Mountain Spotted Fever (RMSF...Fever Vaccine Storage Stability Potency Testing Two lots of Q fever vaccine (NDBR 105) were put on potency test. K. Rocky Mountain Spotted Fever

[Loss of capture by myocardial ischemia: A case report].

PubMed

Sonou, A; Adjagba, P M; Hounkponou, M; Codjo, L; Houéhanou-Sonou, C; Assani, S; Yessoufou, T; Sacca, J; Houénassi, M

2017-02-01

We report the case of a patient with pacemaker who presented chest pain during exercise followed by fainting. He has a history of arterial hypertension and diabetes. The initial examination was normal; the ventricular stimulation threshold was 1.125 volts (V) and cardiac enzymes were normal. Stress test has reproduced chest pain followed by loss of pacemaker capture and asystole. Coronary angiography showed a tight stenosis of the proximal anterior interventricular artery dilated by a drug-eluting stent. The control of stress test was normal. A stent thrombosis eight days later led to an acute coronary syndrome with recurrent syncope due to the loss of ventricular capture. The ventricular pacing threshold was then 2.25V. After revascularization and stabilization of the patient's clinical status, this threshold returned to 1.125V. This clinic case has confirmed that coronary artery disease could increase pacing threshold. It also highlights the usefulness of automatic capture algorithms in coronary patients. The stress test cannot only help to detect coronary artery disease but also allows the optimization of programming the pacemaker. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Examination of acetabular labral tear: a continued diagnostic challenge.

PubMed

Reiman, Michael P; Mather, Richard C; Hash, Thomas W; Cook, Chad E

2014-02-01

Acetabular labrum tears (ALT) are present in 22-55% of individuals with hip or groin pain. Tears can occur as a result of trauma or degeneration and are markedly associated with femoral acetabular morphological variations. An ALT can lead to biomechanical deficiencies and a loss of stability to the coxafemoral joint due to the labrum serving as a stabilising structure of this joint. The diagnosis of ALT is complex and multidimensional. Although tremendous improvements in diagnostic utility for ALT have occurred in the past 25 years, there are few patient history, clinical examination and special test findings that are unique to the condition. Imaging methods such as MRI, CT and ultrasonography have demonstrated reasonable accuracy, but not at a level that allows use as a stand-alone measure. Outcomes measures that focus on functional limitation or that are used to measure recovery should envelop the complexities of the condition and be captured using both self-report and physical performance measures. Only when patient history, objective testing, clinical examination special testing and imaging are combined can a clinician fully elucidate the multidimensional diagnosis of ALT.

Reliability and criterion-related validity testing (construct) of the Endotracheal Suction Assessment Tool (ESAT©).

PubMed

Davies, Kylie; Bulsara, Max K; Ramelet, Anne-Sylvie; Monterosso, Leanne

2018-05-01

To establish criterion-related construct validity and test-retest reliability for the Endotracheal Suction Assessment Tool© (ESAT©). Endotracheal tube suction performed in children can significantly affect clinical stability. Previously identified clinical indicators for endotracheal tube suction were used as criteria when designing the ESAT©. Content validity was reported previously. The final stages of psychometric testing are presented. Observational testing was used to measure construct validity and determine whether the ESAT© could guide "inexperienced" paediatric intensive care nurses' decision-making regarding endotracheal tube suction. Test-retest reliability of the ESAT© was performed at two time points. The researchers and paediatric intensive care nurse "experts" developed 10 hypothetical clinical scenarios with predetermined endotracheal tube suction outcomes. "Experienced" (n = 12) and "inexperienced" (n = 14) paediatric intensive care nurses were presented with the scenarios and the ESAT© guiding decision-making about whether to perform endotracheal tube suction for each scenario. Outcomes were compared with those predetermined by the "experts" (n = 9). Test-retest reliability of the ESAT© was measured at two consecutive time points (4 weeks apart) with "experienced" and "inexperienced" paediatric intensive care nurses using the same scenarios and tool to guide decision-making. No differences were observed between endotracheal tube suction decisions made by "experts" (n = 9), "inexperienced" (n = 14) and "experienced" (n = 12) nurses confirming the tool's construct validity. No differences were observed between groups for endotracheal tube suction decisions at T1 and T2. Criterion-related construct validity and test-retest reliability of the ESAT© were demonstrated. Further testing is recommended to confirm reliability in the clinical setting with the "inexperienced" nurse to guide decision-making related to endotracheal tube suction. The ESAT© is the first validated tool to systematically guide endotracheal nursing practice for the "inexperienced" nurse. © 2018 John Wiley & Sons Ltd.

Exploratory behavior during stance persists with visual feedback.

PubMed

Murnaghan, C D; Horslen, B C; Inglis, J T; Carpenter, M G

2011-11-10

Recent evidence showing center of pressure (COP) displacements increase following an external stabilization of the center of mass (COM) supports the theory that postural sway may be exploratory and serve as a means of acquiring sensory information. The aim of the current study was to further test this theory and rule out potential confounding effects of sensory illusions or motor drift on prior observations. Participants stood as still as possible in an apparatus which allowed movements of the COM to be stabilized ("locked") without subject awareness, and they were provided real-time visual feedback of their COM or COP throughout the trial. If there was an influence of sensory illusions or motor drift, we hypothesized that the change in COP displacement with locking would be reduced when participants were provided visual confirmation of COM stabilization (COM feedback), or when they were aware of the position of the COP throughout the trial (COP feedback). Confirming our previous results, increases in COP displacement were observed when movements of the COM were stabilized. In addition, our results showed that increases in COP displacement could not be explained by the presence of sensory illusions or motor drift, since increases in COP were observed despite being provided convincing evidence that the COM had been stabilized, and when participants were aware of their COP position throughout the trial. These results provide further support for an exploratory role of postural sway. The theoretical basis of current clinical practices designed to deal with balance control deficits due to age or disease is typically based on the opinion that increases in sway are a consequence of a failing balance control system. Our results suggest that this may not be the case, and if sway is in fact exploratory, a serious re-evaluation of current clinical practices may be warranted. Copyright © 2011 IBRO. Published by Elsevier Ltd. All rights reserved.

Validation of value of actual micromotion as a direct measure of implant micromobility after healing (secondary implant stability). An in vivo histologic and biomechanical study.

PubMed

Trisi, Paolo; Berardini, Marco; Falco, Antonello; Podaliri Vulpiani, Michele

2016-11-01

The osseointegration process replaces the surgically damaged bone with newly formed bone in contact to the implant surface. This involves some loss of primary stability, which will continue until new bone is formed providing a new stability, known as "secondary stability." A direct measurement of secondary implant stability appears fundamental to determine the period and modalities for implant loading. The aim of this study was to validate the measurement of the implant micromotion to test secondary implant stability. Twenty-four 3.8 × 11.5 mm implants (Dynamix, Cortex, Shlomi, Israel) were inserted in sheep iliac crests. The animals were sacrificed after 2 months, and the freshly retrieved bone blocks were immediately fixed on a customized device to calculate the value of actual micromotion (VAM) according to a previously described technique. Implant stability quotient (ISQ) values, reverse torque value (RTV), %bone-to-implant contact (%BIC), bone volume percentage (%BV) and crestal bone loss (CBL) were also calculated for each implant. Statistical correlations between VAM and the other parameters were calculated. Data correlation analysis between the examined parameters showed that VAM significantly correlates (P < 0.05) to RTV, %BIC, ISQ and CBL. As VAM showed to be statistical correlated to the other parameters of osseointegration, it may be used to clinically check the amount of implant osseointegration, secondary stability and CBL. Future studies are needed to confirm these results moreover. An instrument to measure VAM in the oral cavity still needs to be developed. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Microparticles Containing Curcumin Solid Dispersion: Stability, Bioavailability and Anti-Inflammatory Activity.

PubMed

Teixeira, C C C; Mendonça, L M; Bergamaschi, M M; Queiroz, R H C; Souza, G E P; Antunes, L M G; Freitas, L A P

2016-04-01

This work aimed at improving the solubility of curcumin by the preparation of spray-dried ternary solid dispersions containing Gelucire®50/13-Aerosil® and quantifying the resulting in vivo oral bioavailability and anti-inflammatory activity. The solid dispersion containing 40% of curcumin was characterised by calorimetry, infrared spectroscopy and X-ray powder diffraction. The solubility and dissolution rate of curcumin in aqueous HCl or phosphate buffer improved up to 3600- and 7.3-fold, respectively. Accelerated stability test demonstrated that the solid dispersion was stable for 9 months. The pharmacokinetic study showed a 5.5-fold increase in curcumin in rat blood plasma when compared to unprocessed curcumin. The solid dispersion also provided enhanced anti-inflammatory activity in rat paw oedema. Finally, the solid dispersion proposed here is a promising way to enhance curcumin bioavailability at an industrial pharmaceutical perspective, since its preparation applies the spray drying, which is an easy to scale up technique. The findings herein stimulate further in vivo evaluations and clinical tests as a cancer and Alzheimer chemoprevention agent.

Clinical characteristics and long-term response to mood stabilizers in patients with bipolar disorder and different age at onset

PubMed Central

Dell’Osso, Bernardo; Buoli, Massimiliano; Riundi, Riccardo; D’Urso, Nazario; Pozzoli, Sara; Bassetti, Roberta; Mundo, Emanuela; Altamura, A Carlo

2009-01-01

Introduction Bipolar disorder (BD) is a prevalent, comorbid, and impairing condition. Potential predictors of response to pharmacological treatment are object of continuous investigation in patients with BD. The present naturalistic study was aimed to assess clinical features and long-term response to mood stabilizers in a sample of bipolar subjects with different ages at onset. Methods The study sample included 108 euthymic patients, diagnosed as affected by BD, either type I or II, according to the DSM-IV-TR, who were started on mood stabilizer treatment. Patients were followed-up for 24 months and the occurrence of any mood episode collected. At the end of the follow-up, patients were divided in 3 subgroups according to the age at onset (early-onset ≤30 years, middle-onset >30–≤45 years, and late-onset >45 years, respectively) and the long-term response to mood stabilizers was compared between them along with other clinical features. Results The three subgroups showed significant differences in terms of clinical and demographic features and, with respect to long-term response to mood stabilizers, the early-onset subgroup showed a better outcome in terms of reduction of major depressive episodes during the 24-month follow-up compared to the other subgroups (one way ANOVA, F = 3.57, p = 0.032). Conclusions Even though further controlled studies are needed to clarify the relationship between age at onset and outcome in BD, the present follow-up study suggests clinical peculiarities and different patterns of response to mood stabilizers across distinct subgroups of patients with BD and different ages at onset. PMID:19649214

[Prescribed drug use for bipolar disorder type I and II in clinical practice].

PubMed

Persson, Charlotte; Kardell, Mathias; Karanti, Alina; Isgren, Anniella; Annerbrink, Kristina; Landen, Mikael

2017-01-10

Prescribed drug use for bipolar disorder type I and II in clinical practice Practice guidelines based on available evidence and clinical consensus are available for the treatment of bipolar disorder. We surveyed to which extent those guidelines are implemented in clinical practice in Sweden. We analysed pharmacological treatment in patients with bipolar disorder in 2015 using the national quality register for bipolar disorder (BipoläR). We compared bipolar disorder type I (BDI) with type bipolar disorder type II (BDII). The vast majority of patients were prescribed a mood stabilizer either as monotherapy or as a part of combination therapy (BDI 87%, BDII 83%, p<0.001). Whereas lithium was the most common mood stabilizer in type I (BDI 65%, BDII 40%, p<0.001), lamotrigine was the most common mood stabilizer in type II (BDI 18%, BDII 42%, p<0.001). Antidepressants were less common in BDI than BDII (35% vs. 53%, p<0.001). Antipsychotic drugs (first or second generation) were more frequently used in BDI than BDII (49% vs 35%, p<0.001). Central stimulants were rarely used (BDI 3.1%, BDII 6.6%, p<0.001). Combining a mood stabilizer with an antipsychotic drug was more common in BDI than BDII (27% vs. 12%, p<0.001), whereas combining a mood stabilizer with an antidepressant was less common in BDI than BDII (16% vs 28%, p<0.001). We conclude that most patients are prescribed mood stabilizers and that the differences between BDI and BDII are rational given the differences in clinical manifestations. The use of antidepressants is surprisingly high given the long-standing debate about the risk and effectiveness of this class in bipolar disorder.

Stability and Repeatability of the Distress Thermometer (DT) and the Edmonton Symptom Assessment System-Revised (ESAS-r) with Parents of Childhood Cancer Survivors.

PubMed

Leclair, Tatsiana; Carret, Anne-Sophie; Samson, Yvan; Sultan, Serge

2016-01-01

Parents report psychological distress in association with their child's cancer. Reliable tools are needed to screen parental distress over the cancer trajectory. This study aimed to estimate the stability and repeatability of the Distress Thermometer (DT) and the Depression and Anxiety items of the Edmonton Symptom Assessment System-revised (ESAS-r-D; -A) in parents of children diagnosed with cancer. Fifty parents (28 mothers, median age = 44) of clinically stable survivors of childhood solid and brain tumours completed questionnaires about their own distress (DT, ESAS-r-D; -A, Brief Symptom Inventory-18: BSI-18, Patient Health Questionnaire-9: PHQ-9, Generalized Anxiety Disorder-7: GAD-7) and their children's quality of life (QoL; Peds Quality of Life: PedsQL) twice, with a month interval between the two assessments. At retest, parents also evaluated life events that occurred between the two time points. Hierarchical regressions explored moderators for the temporal stability of test measures. Stability estimates were ICC = .78 for the DT, .55 for the ESAS-r-D, and .47 for the ESAS-r-A. Caseness agreement between test and retest was substantial for the DT, fair for the ESAS-r-D, and slight for the ESAS-r-A. Repeatability analyses indicated that the error range for the DT was more than 2 pts below/above actual measurement, whereas it was more than 3 pts for the ESAS-r-A, and 2.5 for the ESAS-r-D. Instability of the DT could be explained by changes in children's physical QoL, but not by other components of QoL or life events. No moderators of stability could be identified for the ESAS-r items. The DT appears to be a fairly stable measure when the respondent's condition is stable yet with a relatively wide error range. Fluctuations in distress-related constructs may affect the temporal stability of the DT. The lower stability of ESAS-r items may result from shorter time-lapse instructions resulting in a greater sensitivity to change. Findings support future research on the DT as a reliable instrument in caregivers.

Stability and Repeatability of the Distress Thermometer (DT) and the Edmonton Symptom Assessment System-Revised (ESAS-r) with Parents of Childhood Cancer Survivors

PubMed Central

Carret, Anne-Sophie; Samson, Yvan; Sultan, Serge

2016-01-01

Objective Parents report psychological distress in association with their child's cancer. Reliable tools are needed to screen parental distress over the cancer trajectory. This study aimed to estimate the stability and repeatability of the Distress Thermometer (DT) and the Depression and Anxiety items of the Edmonton Symptom Assessment System-revised (ESAS-r-D; -A) in parents of children diagnosed with cancer. Methods Fifty parents (28 mothers, median age = 44) of clinically stable survivors of childhood solid and brain tumours completed questionnaires about their own distress (DT, ESAS-r-D; -A, Brief Symptom Inventory-18: BSI-18, Patient Health Questionnaire-9: PHQ-9, Generalized Anxiety Disorder-7: GAD-7) and their children’s quality of life (QoL; Peds Quality of Life: PedsQL) twice, with a month interval between the two assessments. At retest, parents also evaluated life events that occurred between the two time points. Hierarchical regressions explored moderators for the temporal stability of test measures. Results Stability estimates were ICC = .78 for the DT, .55 for the ESAS-r-D, and .47 for the ESAS-r-A. Caseness agreement between test and retest was substantial for the DT, fair for the ESAS-r-D, and slight for the ESAS-r-A. Repeatability analyses indicated that the error range for the DT was more than 2 pts below/above actual measurement, whereas it was more than 3 pts for the ESAS-r-A, and 2.5 for the ESAS-r-D. Instability of the DT could be explained by changes in children’s physical QoL, but not by other components of QoL or life events. No moderators of stability could be identified for the ESAS-r items. Conclusions The DT appears to be a fairly stable measure when the respondent's condition is stable yet with a relatively wide error range. Fluctuations in distress-related constructs may affect the temporal stability of the DT. The lower stability of ESAS-r items may result from shorter time-lapse instructions resulting in a greater sensitivity to change. Findings support future research on the DT as a reliable instrument in caregivers. PMID:27454432

Preliminary Results Obtained from Flight Test of a Rocket Model Having the Tail Only of the Grumman XF10F Airplane Configuration, TED No. NACA DE 354

NASA Technical Reports Server (NTRS)

Gardner, William N.; Edmondson, James L.

1950-01-01

A flight test was made to determine the servoplane effectiveness and stability characteristics of the free-floating horizontal stabilizer to be used on the XF10F airplane. The results of this test indicate that servoplane effectiveness is practically constant through the speed range up to a Mach number of 1.15, and the stabilizer static stability is satisfactory. A loss of damping occurs over a narrow Mach number range near M = 1.0, resulting in dynamic instability of the stabilizer in this narrow range. Above M = 1.0 there is a gradual positive trim change of the stabilizer.

Burnout and use of HIV services among health care workers in Lusaka District, Zambia: a cross-sectional study

PubMed Central

Kruse, Gina R; Chapula, Bushimbwa Tambatamba; Ikeda, Scott; Nkhoma, Mavis; Quiterio, Nicole; Pankratz, Debra; Mataka, Kaluba; Chi, Benjamin H; Bond, Virginia; Reid, Stewart E

2009-01-01

Background Well-documented shortages of health care workers in sub-Saharan Africa are exacerbated by the increased human resource demands of rapidly expanding HIV care and treatment programmes. The successful continuation of existing programmes is threatened by health care worker burnout and HIV-related illness. Methods From March to June 2007, we studied occupational burnout and utilization of HIV services among health providers in the Lusaka public health sector. Providers from 13 public clinics were given a 36-item, self-administered questionnaire and invited for focus group discussions and key-informant interviews. Results Some 483 active clinical staff completed the questionnaire (84% response rate), 50 staff participated in six focus groups, and four individuals gave interviews. Focus group participants described burnout as feeling overworked, stressed and tired. In the survey, 51% reported occupational burnout. Risk factors were having another job (RR 1.4 95% CI 1.2–1.6) and knowing a co-worker who left in the last year (RR 1.6 95% CI 1.3–2.2). Reasons for co-worker attrition included: better pay (40%), feeling overworked or stressed (21%), moving away (16%), death (8%) and illness (5%). When asked about HIV testing, 370 of 456 (81%) reported having tested; 240 (50%) tested in the last year. In contrast, discussion groups perceived low testing rates. Both discussion groups and survey respondents identified confidentiality as the prime reason for not undergoing HIV testing. Conclusion In Lusaka primary care clinics, overwork, illness and death were common reasons for attrition. Programmes to improve access, acceptability and confidentiality of health care services for clinical providers and to reduce workplace stress could substantially affect workforce stability. PMID:19594917

Evaluation of Solvita compost stability and maturity tests for assessment of quality of end-products from mixed latrine style compost toilets

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

Hill, Geoffrey B., E-mail: geoff.hill@geog.ubc.ca; Baldwin, Susan A.; Vinnerås, Bjorn

2013-07-15

Highlights: • Solvita® stability and maturity tests used on composting toilet end-product. • Solvita® ammonia better suited in evaluation of feedstock suitability for vermicomposting. • No clear value of Solvita® stability test due to prevalent inhibition of decomposition by ammonia. - Abstract: It is challenging and expensive to monitor and test decentralized composting toilet systems, yet critical to prevent the mismanagement of potentially harmful and pathogenic end-product. Recent studies indicate that mixed latrine composting toilets can be inhibited by high ammonia content, a product of urea hydrolysis. Urine-diverting vermicomposting toilets are better able to accomplish the goals of remote sitemore » human waste management by facilitating the consumption of fecal matter by earthworms, which are highly sensitive to ammonia. The reliability of Solvita® compost stability and maturity tests were evaluated as a means of determining feedstock suitability for vermicomposting (ammonia) and end-product stability/completeness (carbon dioxide). A significant linear regression between Solvita® ammonia and free ammonia gas was found. Solvita® ranking of maturity did not correspond to ranking assigned by ammonium:nitrate standards. Solvita® ammonia values 4 and 5 contained ammonia levels below earthworm toxicity limits in 80% and 100% of samples respectively indicative of their use in evaluating feedstock suitability for vermicomposting. Solvita® stability tests did not correlate with carbon dioxide evolution tests nor ranking of stability by the same test, presumably due to in situ inhibition of decomposition and microbial respiration by ammonia which were reported by the Solvita® CO{sub 2} test as having high stability values.« less

Automated Portable Test System (APTS) - A performance envelope assessment tool

NASA Technical Reports Server (NTRS)

Kennedy, R. S.; Dunlap, W. P.; Jones, M. B.; Wilkes, R. L.; Bittner, A. C., Jr.

1985-01-01

The reliability and stability of microcomputer-based psychological tests are evaluated. The hardware, test programs, and system control of the Automated Portable Test System, which assesses human performance and subjective status, are described. Subjects were administered 11 pen-and-pencil and microcomputer-based tests for 10 sessions. The data reveal that nine of the 10 tests stabilized by the third administration; inertial correlations were high and consistent. It is noted that the microcomputer-based tests display good psychometric properties in terms of differential stability and reliability.

Structural Stability of Mathematical Models of National Economy

NASA Astrophysics Data System (ADS)

Ashimov, Abdykappar A.; Sultanov, Bahyt T.; Borovskiy, Yuriy V.; Adilov, Zheksenbek M.; Ashimov, Askar A.

2011-12-01

In the paper we test robustness of particular dynamic systems in a compact regions of a plane and a weak structural stability of one dynamic system of high order in a compact region of its phase space. The test was carried out based on the fundamental theory of dynamical systems on a plane and based on the conditions for weak structural stability of high order dynamic systems. A numerical algorithm for testing the weak structural stability of high order dynamic systems has been proposed. Based on this algorithm we assess the weak structural stability of one computable general equilibrium model.

Rapid detection of fungal keratitis with DNA-stabilizing FTA filter paper.

PubMed

Menassa, Nardine; Bosshard, Philipp P; Kaufmann, Claude; Grimm, Christian; Auffarth, Gerd U; Thiel, Michael A

2010-04-01

Purpose. Polymerase chain reaction (PCR) is increasingly important for the rapid detection of fungal keratitis. However, techniques of specimen collection and DNA extraction before PCR may interfere with test sensitivity. The purpose of this study was to investigate the use of DNA-stabilizing FTA filter paper (Indicating FTA filter paper; Whatman International, Ltd., Maidstone, UK) for specimen collection without DNA extraction in a single-step, nonnested PCR for fungal keratitis. Methods. Specimens were collected from ocular surfaces with FTA filter discs, which automatically lyse collected cells and stabilize nucleic acids. Filter discs were directly used in single-step PCR reactions to detect fungal DNA. Test sensitivity was evaluated with serial dilutions of Candida albicans, Fusarium oxysporum, and Aspergillus fumigatus cultures. Test specificity was analyzed by comparing 196 and 155 healthy individuals from Switzerland and Egypt, respectively, with 15 patients with a diagnosis of microbial keratitis. Results. PCR with filter discs detected 3 C. albicans, 25 F. oxysporum, and 125 A. fumigatus organisms. In healthy volunteers, fungal PCR was positive in 1.0% and 8.4% of eyes from Switzerland and Egypt, respectively. Fungal PCR remained negative in 10 cases of culture-proven bacterial keratitis, became positive in 4 cases of fungal keratitis, but missed 1 case of culture-proven A. fumigatus keratitis. Conclusions. FTA filter paper for specimen collection together with direct PCR is a promising method of detecting fungal keratitis. The analytical sensitivity is high without the need for a semi-nested or nested second PCR, the clinical specificity is 91.7% to 99.0%, and the method is rapid and inexpensive.

[Aging of silorane- and methacrylate-based composite resins: effects on color and translucency].

PubMed

Liu, Chang; Pan, Jie; Lin, Hong; Shen, Song

2015-10-01

To evaluate the color stability and translucency of silorane-based low shrinkage composite after in vitro aging procedures of thermal cycling and water storage respectively, and to compare with those of conventional methacrylate-based posterior composite. Three light-cured composite resins, dimethacrylate-based composite A (Filtek™ Z350), B (Filtek™ P60) and silorane-based composite C (Filtek™ P90), were tested in this study. Ten specimens (10 mm in diameter, 1 mm in height) of each composite were prepared. The ten specimens in each group were then divided into two subgroups (n = 5). One subgroup underwent thermal cycling [(5.0 ± 0.5)~(55.0 ± 1.0) °C, 10 000 cycles] and the other was stored in 37 C° distilled water for 180 days. With a spectrophotometer, the CIE L * a * b * parameters of the specimens were tested before and after artificial aging against white, medium grey and black backgrounds, respectively. △E, TP and △TP were calculated and data were analyzed using independent-samples t test and partial analysis (P < 0.05). With regard to color stability, silorane-based composite showed color alteration above the clinically acceptable levels (△E > 3.3), and also showed higher △E with a statistically significant difference in comparison with the other composites (B and C) (P < 0.05) after artificial aging. With regard to translucency, composite C showed more alteration compared with composite B (P < 0.05) after thermal cycling. It may be concluded that the silorane-based composite underwent greater alteration with regard to color stability and translucency.

The effect of prolonged storage and disinfection on the dimensional stability of 5 vinyl polyether silicone impression materials.

PubMed

Nassar, Usama; Flores-Mir, Carlos; Heo, Giseon; Torrealba, Ysidora

2017-06-01

Vinyl polyether silicone (VPES) has a different composition from other elastomeric impression materials as it combines vinyl polysiloxane (VPS) and polyether (PE). Therefore, it is important to study its properties and behavior under different test conditions. This study investigated the dimensional stability of 5 VPES consistencies when stored for up to 2 weeks, with and without using a standard disinfection procedure. 40 discs of each VPES consistency (total 200) were made using a stainless steel die and ring as described by ANSI /ADA specification No. 19. 20 discs of each material were immersed in a 2.5% buffered glutaraldehyde solution for 30 minutes. Dimensional stability measurements were calculated immediately after fabrication and repeated on the same discs after 7 and 14 days of storage. The data was analyzed using two-way ANOVA with a significance level set at α = 0.05. The discs mean contraction was below 0.5% at all test times ranging from 0.200 ± 0.014 to 0.325 ± 0.007. Repeated measures ANOVA showed a statistically significant difference after 2-week storage between the disinfected and non-disinfected groups ( P < .001). Although there was no statistically significant difference between the materials at the time of fabrication, the contraction of the materials increased with storage for 1 and 2 weeks. The dimensional changes of VPES impression discs after disinfection and prolonged storage complied with ANSI/ADA standard. The tested VPES impression materials were dimensionally stable for clinical use after disinfection for 30 minutes in glutaraldehyde and storage for up to 2 weeks.

The impact of laser irradiation on global stability in patients with vertebrobasilar insufficiency: A clinical report

PubMed Central

Lukowicz, Malgorzata; Zalewski, Pawel; Bulatowicz, Irena; Buszko, Katarzyna; Klawe, Jacek J.

2011-01-01

Summary Background The purpose of our experiment was to determine whether laser stimulation can improve microcirculation in the posterior regions of the brain in patients with vertebrobasilar insufficiency (VBI). Material/Methods We studied 25 patients (20 female, 5 male, mean age 64) diagnosed with chronic VBI. All were evaluated using the De Klyn test, followed by qualitative assessment of stability using a Berg Balance Scale and evaluation of global stability using an electronic balance platform. A CTL-1100 low power laser was used with standard parameters. We established a protocol for laser irradiation at 5 points along the vertebral artery in the cervical region bilaterally. Irradiation was performed 10 times over two weeks. Results Significant improvement occurred after therapy in headache (p=0.0005), vertigo (p<0.0000), and tinnitus (p=0.0387). No significant differences were observed in nausea or nystagmus caused by head rotation. The Berg Balance Scale results showed significant differences in almost all features. There was a tendency towards improved stability in all parameters, and statistically significant differences in the total surface of support and the spread surface of support for the left foot. Conclusions Laser stimulation as applied in this study can be useful in the treatment of patients with VBI. The main reason for improvement in global stability, balance, and other VBI symptoms is better blood perfusion. PMID:21873949

Comparative effectiveness of lumbar stabilization, dynamic strengthening, and Pilates on chronic low back pain: randomized clinical trial.

PubMed

Bhadauria, Esha A; Gurudut, Peeyoosha

2017-08-01

The aim of the present study was to compare three different forms of exercises namely lumbar stabilization, dynamic strengthening, and Pilates on chronic low back pain (LBP) in terms of pain, range of motion, core strength and function. In this study, 44 subjects suffering from non-specific LBP for more than 3 months were randomly allocated into the lumbar stabilization group, the dynamic strengthening group, and the Pilates group. Ten sessions of exercises for 3 weeks were prescribed along with interferential current and hot moist pack. Pain was assessed by visual analog scale, functional affection by modified Oswestry Disability Questionnaire, range of motion by assessing lumbar flexion and extension by modified Schober test and core strength was assessed by pressure biofeedback on day 1 and day 10 of the treatment. There was reduction of pain, improvement in range of motion, functional ability and core strength in all the 3 exercise groups. The improvement was significantly greater in the lumbar stabilization group for all the outcome measures, when compared the posttreatment after 10th session. Pairwise comparison showed that there was greater reduction of disability in the Pilates group than the dynamic strengthening group. It was concluded that the lumbar stabilization is more superior compared to the dynamic strengthening and Pilates in chronic nonspecific LBP. However, long-term benefits need to be assessed and compared with prospective follow-up studies.

46 CFR 170.085 - Information required before a stability test.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 7 2010-10-01 2010-10-01 false Information required before a stability test. 170.085... STABILITY STABILITY REQUIREMENTS FOR ALL INSPECTED VESSELS Plan Approval § 170.085 Information required... the information prescribed in § 170.185(g) must be submitted to the Coast Guard Marine Safety Center...

Influence of surface sealing on color stability and roughness of composite submitted to ultraviolet-accelerated aging.

PubMed

Catelan, Anderson; Suzuki, Thaís Yumi Umeda; Becker, Francisco; Briso, André Luiz Fraga; Dos Santos, Paulo Henrique

2017-05-01

In the present study, we evaluated the influence of surface sealing on color stability and surface roughness of a composite resin after accelerated artificial aging. Thirty-two specimens of a composite were prepared. After 24 h, the specimens were polished and divided into four groups (n = 8), according to the surface sealant used, including the control, which had no sealant application. Baseline color was measured according to the CIELab system using a reflection spectrophotometer. Surface roughness was determined using a profilometer with a cut-off of 0.25 mm. After these tests, specimens were aged for 252 h in an ultraviolet (UV)-accelerated aging chamber. Color stability was determined by difference between coordinates obtained before and after the aging procedure. Data of color change and roughness were evaluated by anova and Fisher's exact test (α = 0.05). The results showed that the unsealed group had the highest color change compared to other groups (P = 0.0289), and there was no significant difference between groups sealed with surface sealant (P > 0.05). The artificial aging caused an increase in roughness values independent of the experimental group studied (P = 0.0015). The sealed composites showed lower color change after UV aging, but all groups showed clinically-acceptable color change, and only liquid polish decreased roughness. © 2016 John Wiley & Sons Australia, Ltd.

Comparison of Collection Methods for Fecal Samples in Microbiome Studies

PubMed Central

Vogtmann, Emily; Chen, Jun; Amir, Amnon; Shi, Jianxin; Abnet, Christian C.; Nelson, Heidi; Knight, Rob; Chia, Nicholas; Sinha, Rashmi

2017-01-01

Prospective cohort studies are needed to assess the relationship between the fecal microbiome and human health and disease. To evaluate fecal collection methods, we determined technical reproducibility, stability at ambient temperature, and accuracy of 5 fecal collection methods (no additive, 95% ethanol, RNAlater Stabilization Solution, fecal occult blood test cards, and fecal immunochemical test tubes). Fifty-two healthy volunteers provided fecal samples at the Mayo Clinic in Rochester, Minnesota, in 2014. One set from each sample collection method was frozen immediately, and a second set was incubated at room temperature for 96 hours and then frozen. Intraclass correlation coefficients (ICCs) were calculated for the relative abundance of 3 phyla, 2 alpha diversity metrics, and 4 beta diversity metrics. Technical reproducibility was high, with ICCs for duplicate fecal samples between 0.64 and 1.00. Stability for most methods was generally high, although the ICCs were below 0.60 for 95% ethanol in metrics that were more sensitive to relative abundance. When compared with fecal samples that were frozen immediately, the ICCs were below 0.60 for the metrics that were sensitive to relative abundance; however, the remaining 2 alpha diversity and 3 beta diversity metrics were all relatively accurate, with ICCs above 0.60. In conclusion, all fecal sample collection methods appear relatively reproducible, stable, and accurate. Future studies could use these collection methods for microbiome analyses. PMID:27986704

The Influence of Tactile Perception on Classification of Bone Tissue at Dental Implant Insertion.

PubMed

Linck, Gláucia Kelly Silva Barbosa; Ferreira, Geovane Miranda; De Oliveira, Rubelisa Cândido Gomes; Lindh, Christina; Leles, Cláudio Rodrigues; Ribeiro-Rotta, Rejane Faria

2016-06-01

Various ways of using the Lekholm and Zarb (L&Z) classification have added to the lack of scientific evidence of the effectiveness of this clinical method in the evaluation of implant treatment. The study aims to assess subjective jawbone classifications in patients referred for implant treatment, using L&Z classification with and without surgeon's hand perception at implant insertion. The association between bone type classifications and quantitative parameters of primary implant stability was also assessed. One hundred thirty-five implants were inserted using conventional loading protocol. Three surgeons classified bone quality at implant sites using two methods: one based on periapical and panoramic images (modified L&Z) and one based on the same images associated with the surgeon's tactile perception during drilling (original L&Z). Peak insertion torque and implant stability quotient (ISQ) were recorded. The modified and original L&Z were strongly correlated (rho = 0.79; p < .001); Wilcoxon signed-rank test showed no significant difference in the distribution of bone type classification between pairs using the two methods (p = .538). Spearman correlation tested the association between primary stability parameters and bone type classifications (-0.34 to -0.57 [p < .001]). Tactile surgical perception has a minor influence on rating of subjective bone type for dental implant treatment using the L&Z classification. © 2015 Wiley Periodicals, Inc.

Two-Implant-Supported Mandibular Overdentures: Do Clinical Denture Quality and Inter-Implant Distance Affect Patient Satisfaction?

PubMed

Alfadda, Sara A; Al Amri, Mohammad D; Al-Ohali, Amal; Al-Hakami, Arwa; Al-Madhi, Noura

To investigate the following three null hypotheses in patients rehabilitated with a mandibular overdenture supported by two unsplinted implants: (1) patient satisfaction is not related to the clinical quality of the dentures; (2) inter-implant distance (IID) has no effect on the clinical quality of the dentures; and (3) IID does not influence patient satisfaction. Forty edentulous patients who were rehabilitated with a two-implant-supported mandibular overdenture participated in the study. Independent investigators evaluated the dentures on the basis of five clinical criteria using the validated Denture Quality Evaluation Form, and the patients completed the validated Denture Satisfaction Scale. Irreversible hydrocolloid impressions of the mandible were made and poured immediately in die stone. The IID was measured by adapting an orthodontic wire to the mandibular alveolar ridge crest, extending from the center of one implant to the center of the other. Spearman correlation analyses were used to identify possible correlations, with a significance level set at P < .05. The clinicians' overall mean rating of the clinical quality of the dentures was 91.5% (standard deviation 6.27%). The stability of the mandibular overdenture and of the maxillary conventional complete denture was significantly related to satisfaction (r = 0.389 and r = 0.44, respectively). Significant associations were found between the mandibular stability items and satisfaction with both maxillary and mandibular dentures. The stability of the maxillary denture was significantly associated with patient satisfaction with mandibular denture retention, stability, and comfort. None of the 12 denture satisfaction items were significantly associated with IID. Similarly, IID did not have an effect on the quality of either denture in terms of retention, stability, or occlusion. Denture stability was the feature that had the most influence on patient satisfaction with the mandibular overdenture and with the maxillary conventional denture. IID had no effect on the clinical quality of either denture and did not influence patient satisfaction.

Longitudinal performance of infants with cerebral palsy on the Test of Infant Motor Performance and on the Alberta Infant Motor Scale.

PubMed

Barbosa, Vanessa M; Campbell, Suzann K; Sheftel, David; Singh, Jaidep; Beligere, Nagamani

2003-01-01

Understanding the natural history of development in children with cerebral palsy (CP) is important for studying the consequences of early intervention. The purpose of this paper is to present results on the Test of Infant Motor Performance (TIMP) from 0-4 months of age and on the Alberta Infant Motor Scale (AIMS) from 3 to 12 months of age in a group of infants later diagnosed as having CP. Ages at which infants with CP were first recognized as having delayed motor performance on each instrument and the stability of performance over time are presented. Clinical implications for using both instruments are discussed.

Medical stabilization of adolescents with nutritional insufficiency: a clinical care path.

PubMed

Strandjord, Sarah E; Sieke, Erin H; Richmond, Miranda; Khadilkar, Arjun; Rome, Ellen S

2016-09-01

Nutritional insufficiency (NI) is a potential consequence of restrictive eating disorders. NI patients often require hospitalization for refeeding to restore medical stability and prevent complications such as refeeding syndrome. Limited information is available on the optimal approach to refeeding. In this study, we describe an inpatient NI care path and compare treatment outcomes at an academic medical center and a community hospital. A retrospective chart review was conducted on inpatients treated using a standardized NI care path at either the academic site, from August 2012 to July 2013 (n = 51), or the community site, from August 2013 to July 2014 (n = 39). Demographic information, eating disorder history, and treatment variables were recorded for each patient. Data were compared using the Kruskal-Wallis test and Fisher's exact test. Patients admitted to the community site had shorter hospital stays than patients admitted to the academic site (IQR 2-4 vs. 2-7 days, p = 0.03). All patients were discharged in <14 days with a median stay of 3 days. The median initial calorie prescription was 2200 calories for both groups. No clinical cases of refeeding syndrome occurred, with only one patient developing hypophosphatemia during refeeding. A standardized care path with a higher-calorie intervention allows for short-term hospitalization of NI patients without increasing the risk of refeeding syndrome, regardless of treatment site. This study demonstrates the efficiency and safety of treating NI patients on a regular medical floor at a community hospital.

Effect of denture cleansers on color stability, surface roughness, and hardness of different denture base resins

PubMed Central

Porwal, Anand; Khandelwal, Meenakshi; Punia, Vikas; Sharma, Vivek

2017-01-01

Aim: The purpose of this study was to evaluate the effect of different denture cleansers on the color stability, surface hardness, and roughness of different denture base resins. Materials and Methods: Three denture base resin materials (conventional heat cure resin, high impact resin, and polyamide denture base resin) were immersed for 180 days in commercially available two denture cleansers (sodium perborate and sodium hypochlorite). Color, surface roughness, and hardness were measured for each sample before and after immersion procedure. Statistical Analysis: One-way analysis of variance and Tukey's post hoc honestly significant difference test were used to evaluate color, surface roughness, and hardness data before and after immersion in denture cleanser (α =0.05). Results: All denture base resins tested exhibited a change in color, surface roughness, and hardness to some degree in both denture cleansers. Polyamides resin immersed in sodium perborate showed a maximum change in color after immersion for 180 days. Conventional heat cure resin immersed in sodium hypochlorite showed a maximum change in surface roughness and conventional heat cure immersed in sodium perborate showed a maximum change in hardness. Conclusion: Color changes of all denture base resins were within the clinically accepted range for color difference. Surface roughness change of conventional heat cure resin was not within the clinically accepted range of surface roughness. The choice of denture cleanser for different denture base resins should be based on the chemistry of resin and cleanser, denture cleanser concentration, and duration of immersion. PMID:28216847

Contribution of Jules Froment to the study of parkinsonian rigidity.

PubMed

Broussolle, Emmanuel; Krack, Paul; Thobois, Stéphane; Xie-Brustolin, Jing; Pollak, Pierre; Goetz, Christopher G

2007-05-15

Rigidity is commonly defined as a resistance to passive movement. In Parkinson's disease (PD), two types of rigidity are classically recognized which may coexist, "leadpipe " and "cogwheel". Charcot was the first to investigate parkinsonian rigidity during the second half of the nineteenth century, whereas Negro and Moyer described cogwheel rigidity at the beginning of the twentieth century. Jules Froment, a French neurologist from Lyon, contributed to the study of parkinsonian rigidity during the 1920s. He investigated rigidity of the wrist at rest in a sitting position as well as in stable and unstable standing postures, both clinically and with physiological recordings using a myograph. With Gardère, Froment described enhanced resistance to passive movements of a limb about a joint that can be detected specifically when there is a voluntary action of another contralateral body part. This has been designated in the literature as the "Froment's maneuver " and the activation or facilitation test. In addition, Froment showed that parkinsonian rigidity diminishes, vanishes, or enhances depending on the static posture of the body. He proposed that in PD "maintenance stabilization " of the body is impaired and that "reactive stabilization " becomes the operative mode of muscular tone control. He considered "rigidification " as compensatory against the forces of gravity. Froment also demonstrated that parkinsonian rigidity increases during the Romberg test, gaze deviation, and oriented attention. In their number, breadth, and originality, Froment's contributions to the study of parkinsonian rigidity remain currently relevant to clinical and neurophysiological issues of PD. (c) 2007 Movement Disorder Society.

Stressed Stability Techniques for Adjuvant Formulations.

PubMed

Hasija, Manvi; Sheung, Anthony; Rahman, Nausheen; Ausar, Salvador F

2017-01-01

Stressed stability testing is crucial to the understanding of mechanisms of degradation and the effects of external stress factors on adjuvant stability. These studies vastly help the development of stability indicating tests and the selection of stabilizing conditions for long term storage. In this chapter, we provide detailed protocols for the execution of forced degradation experiments that evaluate the robustness of adjuvant formulations against thermal, mechanical, freeze-thawing, and photo stresses.

Evaluation of local cancellous bone amelioration by poly-L-DL-lactide copolymers to improve primary stability of dental implants: a biomechanical study in sheep.

PubMed

Stübinger, Stefan; Waser, Jasmin; Hefti, Thomas; Drechsler, Anika; Sidler, Michéle; Klein, Karina; von Rechenberg, Brigitte; Schlottig, Falko

2015-05-01

The aim of this study was to evaluate the clinical performance of local cancellous bone amelioration by a 70:30 poly-(L-lactide-co-D,L-Lacide) copolymer with two different implant designs on primary stability and after 4 and 12 weeks of healing time. In six sheep, n = 36 implants (TH) with a conditioned, sandblasted, thermal acid-etched micro-rough surface and n = 36 implants (NB) with a highly crystalline and phosphate-enriched anodized titanium oxide surface were placed in the pelvic bone. Using an ultrasound-based process named Constant Amelioration Process (CAP), half of peri-implant trabecular bone structures were locally tested with 70:30 poly-(L-lactide-co-D,L-Lacide) copolymer in both implant groups, TH and NB. The CAP technology employs ultrasonic energy to liquefy 70:30 poly-(L-lactide-co-D,L-Lacide) which enters the inter-trabecular space, leading to local reinforcement of the cancellous bone structure after solidification of the copolymer. The CAP test group was compared with reference implants placed with the conventional site preparation according to the manufacturers' description. Primary stability was assessed by the measurement of torque-in values and implant stability quotient (ISQ; n = 18 per group). Secondary stability was analyzed by biomechanical removal torque testing after 4 and 12 weeks (n = 9 per group). Insertion torque value (23.3 N cm ± 13.6) of reference TH implants demonstrated a statistically significant (P = 0.00) difference in comparison with test TH implants (41.9 N cm ± 19.5). Reference NB implants revealed a statistically significant (P = 0.03) lower insertion torque value (23.7 N cm ± 13.5) than test NB implants (39.7 N cm ± 18.6). ISQ values increased for all implants from initial implant placement until sacrifice at 12 weeks. Reference TH implants tended to result in an increase in torque values from 4 weeks (181.9 N cm ± 22.8) to 12 weeks (225.7 N cm ± 47.4). This trend could be also proven for implants of test sites (4 week: 176.8 N cm ± 24.1; 12 week: 201.5 N cm ± 53.4). For reference, NB implants a non-significant increase in removal torque values from 4 weeks (146. 7 N cm ± 18.0) to 12 weeks (170.2 N cm ± 40.4) was observed. Removal torque values of test NB implants did not increase from 4 weeks (153.3 N cm ± 21.5) to 12 weeks (146.1 N cm ± 37.5). Biomechanical data proved significantly enhanced primary stability of dental implants after local amelioration without long-term sequelae and irrespective of implant design. After 4- and 12-week healing time, removal torque of locally test implants was as high as for control implants, and osseointegration was therefore not influenced by the CAP process. No correlation between ISQ values and torque values was found. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Diagnostic Stability of ICD/DSM First Episode Psychosis Diagnoses: Meta-analysis

PubMed Central

Fusar-Poli, Paolo; Cappucciati, Marco; Rutigliano, Grazia; Heslin, Margaret; Stahl, Daniel; Brittenden, Zera; Caverzasi, Edgardo; McGuire, Philip; Carpenter, William T.

2016-01-01

Background: Validity of current International Classification of Disease/Diagnostic and Statistical Manual of Mental Disorders (ICD/DSM) first episode psychosis diagnoses is essential in clinical practice, research, training and public health. Method: We provide a meta-analytical estimate of prospective diagnostic stability and instability in ICD-10 or DSM-IV first episode diagnoses of functional psychoses. Independent extraction by multiple observers. Random effect meta-analysis conducted with the “metaprop,” “metaninf,” “metafunnel,” “metabias,” and “metareg” packages of STATA13.1. Moderators were tested with meta-regression analyses. Heterogeneity was assessed with the I 2 index. Sensitivity analyses tested robustness of results. Publication biases were assessed with funnel plots and Egger’s test. Findings: 42 studies and 45 samples were included, for a total of 14 484 first episode patients and an average follow-up of 4.5 years. Prospective diagnostic stability ranked: schizophrenia 0.90 (95% CI 0.85–0.95), affective spectrum psychoses 0.84 (95% CI 0.79–0.89), schizoaffective disorder 0.72 (95% CI 0.61–0.73), substance-induced psychotic disorder 0.66 (95% CI 0.51–0.81), delusional disorder 0.59 (95% CI 0.47–0.71), acute and transient psychotic disorder/brief psychotic disorder 0.56 (95% CI 0.62–0.60), psychosis not otherwise specified 0.36 (95% CI 0.27–0.45, schizophreniform disorder 0.29 (95% CI 0.22–0.38). Diagnostic stability within schizophrenia spectrum psychoses was 0.93 (95% CI 0.89–0.97); changes to affective spectrum psychoses were 0.05 (95% CI 0.01–0.08). About 0.10 (95% CI 0.05–0.15) of affective spectrum psychoses changed to schizophrenia spectrum psychosis. Across the other psychotic diagnoses there was high diagnostic instability, mostly to schizophrenia. Interpretation: There is meta-analytical evidence for high prospective diagnostic stability in schizophrenia spectrum and affective spectrum psychoses, with no significant ICD/DSM differences. These results may inform the development of new treatment guidelines for early psychosis and impact drug licensing from regulatory agencies. PMID:26980142

[Study on the stability of tetrandrine microsphere].

PubMed

Cheng, Guohu; Luo, Jiabo

2005-05-01

To study the stability of Tetrandrine Microsphere. Higher speed test and room temperature test were adopted to investigate the indexes, such as properties of appearance, amount of medicine loaded, seal rate, seepage rate, microbial stability, etc. Through the test of six months, properties of appearance, amount of medicine loaded, seal rate, seepage rate, microbial stability have not obviously change. But after testing for 6 months with higher temperature, the seal rate was reduced, and the seepage rate was increased. Tetrandrine microsphere is steady under the room temperature condition, but is unstable to hot, and ought to keep in conformity with low-temperature.

The Longitudinal Stability of Flying Boats as Determined by Tests of Models in the NACA Tank II : Effect of Variations in Form of Hull on Longitudinal Stability

NASA Technical Reports Server (NTRS)

Olson, Roland E.; Truscott, Starr

1942-01-01

Data taken from tests at constant speed to establish trim limits of stability, tests at accelerated speeds to determine stable limits of center of gravity shift, and tests at decelerated speeds to obtain landing characteristics of several model hull forms were used to establish hull design effect on longitudinal stability of porpoising. Results show a reduction of dead rise angle as being the only investigated factor reducing low trim limit. Various methods of reducing afterbody interference increased upper trim limit

Effect of Temperature and Time on Fecal Hemoglobin Stability in 5 Fecal Immunochemical Test Methods and One Guaiac Method.

PubMed

Catomeris, Peter; Baxter, Nancy N; Boss, Sheila C; Paszat, Lawrence F; Rabeneck, Linda; Randell, Edward; Serenity, Mardie L; Sutradhar, Rinku; Tinmouth, Jill

2018-01-01

- Although promising for colorectal cancer screening, hemoglobin (Hb) stability remains a concern with fecal immunochemical tests. This study implemented a novel, standardized method to compare Hb stability across various fecal immunochemical tests. The method can be used to inform decisions when selecting a kit for use in colorectal cancer screening. In so doing, this work addressed a critical need for standardization in this field. - To compare the stability of Hb across 5 different immunochemical kits and one guaiac kit. - The stability of Hb was analyzed in collection devices inoculated with Hb-spiked feces and (1) stored at various temperatures (frozen, refrigerated, ambient, and elevated) for more than 60 days; (2) after undergoing 3 controlled, freeze-thaw cycles; and (3) after being transported by courier or postal services in uncontrolled temperature conditions from 3 locations in Ontario, Canada, to a central testing center. - The stability of Hb varied with time and temperature and by kit. Lower Hb recoveries occurred with increasing temperature and increasing time from sample collection to testing. Refrigeration provided the best stability, although results varied across kits (eg, from 4.2 days to >60 days before a prespecified threshold [<70% probability of the test results remaining positive] was reached). Freeze-thaw stability varied across kits and cycles (Hb recoveries: NS Plus [Alfresa Pharma, Chuo-ku, Osaka, Japan], 91.7% to 95.4%; OC Diana [Eiken Chemical, Taito-ku, Tokyo, Japan], 57.6% to 74.9%). Agreement regarding Hb levels before and after transportation varied across kits (from 57% to 100%). - Important differences in Hb stability were found across the included fecal immunochemical tests. These findings should inform practice-based and population-based colorectal cancer screening.

Evaluation of warfarin management with international normalized ratio self-testing and online remote monitoring and management plus low-dose vitamin k with genomic considerations: a pilot study.

PubMed

Bussey, Henry I; Bussey, Marie; Bussey-Smith, Kristin L; Frei, Christopher R

2013-11-01

As better international normalized ratio (INR) control and self-testing reduce events in warfarin-treated patients, and vitamin K supplementation may improve INR control, our primary objective was to evaluate the effect of a system combining frequent INR self-testing with online remote monitoring and management (STORM₂) and low-dose vitamin K supplementation on INR control; our secondary objectives were to assess the impact of STORM₂ on clinician time and to evaluate the influence of pharmacogenomics on INR stability and warfarin dose after vitamin K supplementation. Prospective pre- and postintervention study. Freestanding clinical research center. Fifty-five patients treated with long-term warfarin therapy who were referred from four anticoagulation clinics and seven medical practices. All patients performed weekly INR self-testing and received vitamin K 100 µg/day and online anticoagulation management for 1 year. INR control and time required for anticoagulation management were assessed, and an analysis of warfarin dosing and INR stability by genetic polymorphism subgroup (vitamin K epoxide reductase complex 1 [VKORC1] and cytochrome P450 2C9 isoenzyme) was performed; vitamin K product content was also analyzed. The percentage of time that the INR is within the time in therapeutic range (TTR) improved from 56% before the intervention to 81% after the intervention (p<0.0001), and time spent at extreme INR values of lower than 1.5 or higher than 5 was reduced from 3.1% to 0.4% (p=0.01). Clinician time was less than 10 minutes per four patient visits per month. Genetic polymorphisms did not correlate with INR stability or the increase in warfarin dose after vitamin K supplementation. The content of the vitamin K product, however, was only 34-76% of the labeled amount. Patients with the GG VKORC1 genotype required a higher warfarin dose than predicted by the genomic-based dosing chart in the warfarin package insert. The 25% point improvement in TTR with STORM₂ is a greater improvement than reported previously with other efforts to improve TTR. STORM₂ required a minimum amount of clinician time. Pharmacogenomics were not predictive of improved INR control or the magnitude of the warfarin dose after vitamin K supplementation, although the content of the product was unreliable. Patients with the GG VKORC1 genotype required a higher warfarin dose than predicted by the product information. The potential clinical impact of improved INR control with this method warrants comparisons with conventionally managed warfarin and with the new oral anticoagulants. © 2013 Pharmacotherapy Publications, Inc.

High Reynolds Number Thermal Stability Experiments

NASA Technical Reports Server (NTRS)

Emens, Jessica M.; Brown, Sarah P.; Frederick Robert A., Jr.; Wood, A. John

2004-01-01

This work represents preliminary thermal stability results for liquid hydrocarbon fuels. High Reynolds Number Thermal Stability experiments with Jet A and RP-1 resulted in a quantitative measurement of the thermal stability. Each fuel flowed through a heated capillary tube that held the outlet temperature at 290 C. An optical pyrometer measured the surface temperature of the tube at 12 locations as a function of time. The High Reynolds Number Thermal Stability number was then determined using standards published by the American Society for Testing and Materials. The results for Jet A showed lower thermal stability than similar tests conducted at another facility. The RP-1 results are the first reported using this technique. Because the temperature rise on the capillary tube during testing for the RP-1 fuels was not significant, a new standard for the testing conditions should be developed for these types of fuels.

Clinical characteristics and surgical experience of Type III Wagstaffe fractures: Pay attention to concomitant chondral injury of the talus.

PubMed

Zhang, Ming; Chen, Yun-Feng; Wang, Lei; Li, Fan; Wei, Hai-Feng; Shi, Zhong-Min

2017-04-27

The purpose of this study was to investigate clinical characteristics and surgical management of Type III Wagstaffe fracture. From August 2012 to July 2015, 13 patients with Type III Wagstaffe fractures were surgically treated. During operation, the cartilage of joint surface was explored. Wagstaffe fragment was fixed with cannulated screw or suture, Chaput fragment was fixed with cannulated screw or plate, and Cotton test was performed to evaluate the stability of syndesmosis during the operation. All the patients were followed up for 14.3 months in average. Clinical outcome was assessed with Olerud-Molander score and American Orthopedic Foot and Ankle Society (AOFAS) score. The traumatic arthritis was evaluated with osteoarthritis-score (OA-score). During the operation, chondral injury was found on the lateral top of the talus in 8 cases, as "kissing lesion" of Chaput fragment. The fractures healed uneventfully and all the patients recovered satisfactorily except two had moderate restriction in ankle movement. The average Olerud-Molander score and AOFAS score were 82.3 and 86.1, respectively. Type III Wagstaffe is a rare and often missed fracture. 61% are associated with a chondral lesion on the lateral top of the talus. Anatomical reduction and rigid fixation of both fragments are mandatory to obtain ankle stability and good results. Copyright © 2017 European Foot and Ankle Society. Published by Elsevier Ltd. All rights reserved.

Peritoneal drainage does not stabilize extremely low birth weight infants with perforated bowel: data from the NET Trial.

PubMed

Rees, Clare M; Eaton, Simon; Khoo, A Kate; Kiely, Edward M; Pierro, Agostino

2010-02-01

Proponents of peritoneal drainage (PD) hypothesize that it allows stabilization before laparotomy. We examined this hypothesis by comparing clinical status before and after either PD or primary laparotomy (LAP). In an ethically approved, international, prospective randomized controlled trial (2002-2006), extremely low birth weight (<1000 g) infants with pneumoperitoneum received primary PD (n = 35) or LAP (n = 34). Physiologic data were collected prospectively and organ failure scores calculated and compared between preprocedure and day 1 after procedure. Data, expressed as mean +/- SD or median (range), were analyzed using appropriate statistical tests. There was no postprocedure improvement in either PD or LAP group comparing heart rate (PD, P = 1.0; LAP, P = .6), blood pressure (PD, P = .6; LAP, P = .8), inotrope requirement (PD, P = .2; LAP, P = .3), or Arterial partial pressure of oxygen/fraction of inspired oxygen ratio (PD, P = .1; LAP, P = .5). Infants managed with PD had a worsening cardiovascular status (P = .05). There were no differences in total organ failure score in either group (PD, P = .5; LAP, P = 1). Only 4 infants survived with PD alone with no difference between preprocedure and postprocedure organ failure score (P = .4). Peritoneal drainage does not immediately improve clinical status in extremely low birth weight infants with bowel perforation. The use of PD as a stabilizing or temporizing measure is not supported by these results. Copyright 2010 Elsevier Inc. All rights reserved.

Test-retest reliability and responsiveness of gaze stability and dynamic visual acuity in high school and college football players.

PubMed

Kaufman, Denise R; Puckett, Mallory J; Smith, Mitchell J; Wilson, Kyle S; Cheema, Rebecca; Landers, Merrill R

2014-08-01

The purpose of this study was to establish reliability and responsiveness of the dynamic visual acuity test (DVAT) at head speeds of 150-200 degrees per second (deg/s) and the gaze stabilization test (GST) in high school and college football players. Reliability design. Fifty high school and college football athletes completed the DVAT and GST in both the yaw (horizontal) and pitch (vertical) planes twice within two weeks. Test-retest reliability for the DVAT was good in yaw, Intraclass Correlation Coefficient (ICC) = 0.770, and moderate/good in pitch, ICC = 0.725. Minimal detectable change (MDC) was 0.16 logMAR for yaw and 0.21 logMAR for pitch. GST reliability was moderate in yaw, ICC = 0.634, and poor in pitch, ICC = 0.411. MDCs were 73.4 deg/s (yaw) and 81.2 deg/s (pitch). The DVAT is reliable at high head speeds in high school and college football athletes in both yaw and pitch. GST head speeds were higher than previously reported in the literature, but reliability of this tool for this population was poor to moderate. From a clinical perspective, DVAT may be reliably used in the assessment of high school and college football athletes; however, GST requires further evaluation. Copyright © 2013 Elsevier Ltd. All rights reserved.

[Basic Studies on the Stability of Flavored Oral Solutions of Rebamipide].

PubMed

Yajima, Ryo; Imaoka, Futa; Wako, Tetsuya; Kuroda, Yuko; Matsumoto, Kazuaki; Kizu, Junko; Katayama, Shiro

2015-01-01

Stomatitis frequently occurs during chemotherapy and radiotherapy for cancer. Because of its pharmacological properties including anti-inflammatory activity and stimulatory effects on endogenous prostaglandin synthesis, rebamipide has been suggested as a potentially effective treatment against stomatitis. In the present study we tested the stability of oral rebamipide solutions prepared in our hospital pharmacy using sodium alginate as a thickener to increase retention of this agent in the oral cavity, and the addition of different flavoring mixtures intended for use in enteral diets to reduce the bitterness of rebamipide and sodium alginate. Samples of oral rebamipide solution prepared with 13 kinds of flavoring and sodium alginate were evaluated in terms of their appearance, redispersibility, pH, viscosity, and rebamipide content immediately after preparation and 1, 3, 7, and 10 days after storage at room temperature under ambient light or in a cool, dark place. After 10 days of storage, favorable stability was observed in four sample solutions supplemented with green apple, pineapple, yogurt, and tomato flavoring mixtures intended for use in Elental(®) diets. These oral solutions may have potential clinical application.

Stability enhanced, repeatability improved Parylene-C passivated on QCM sensor for aPTT measurement.

PubMed

Yang, Yuchen; Zhang, Wei; Guo, Zhen; Zhang, Zhiqi; Zhu, Hongnan; Yan, Ruhong; Zhou, Lianqun

2017-12-15

Determination of blood clotting time is essential in monitoring therapeutic anticoagulants. In this work, Parylene-C passivated on quartz crystal microbalance (P-QCM) was developed for the activated partial thromboplastin time (aPTT) measurement. Compared with typical QCM, P-QCM possessed a hydrophobic surface and sensitive frequency response to viscoelastic variations on electrode surface. Fibrin could be adsorbed effectively, due to the hydrophobicity of the P-QCM surface. Comparing with typical QCM, the peak-to-peak value (PPV) of P-QCM was increased by 1.94% ± 0.63%, which indicated enhancement of signal-to-noise ratio. For P-QCM, the coefficient of variation (CV) of frequency decrease and aPTT were 2.58% and 1.24% separately, which demonstrated improvement of stability and reproducibility. Moreover, compared with SYSMEX CS 2000i haematology analyzer, clinical coefficient index (R 2 ) was 0.983. In conclusion, P-QCM exhibited potential for improving stability, reproducibility and linearity of piezoelectric sensors, and might be more promising for point of care testing (POCT) applications. Copyright © 2017 Elsevier B.V. All rights reserved.

Control of mediolateral stability during rapid step initiation with preferred and non-preferred leg: is it symmetrical?

PubMed

Yiou, E; Do, M C

2010-05-01

During voluntary stepping initiation, postural stability along the mediolateral direction is controlled via "anticipatory postural adjustment" (APA). This study tested the hypothesis that, in young healthy subjects, the biomechanical features of mediolateral APA depend on the leg that initiates stepping. Subjects (N=10) initiated a rapid single step with the preferred (P condition) and the non-preferred leg (NP condition) on a force-plate. Results showed that mediolateral APA duration (P=0.020) and amplitude were higher (as attested by the increase in maximal center-of-gravity velocity (P=0.003) and displacement (P<0.001) during APA), and that mediolateral stability was better (as attested by the attenuation in center-of-gravity velocity at time of swing-foot contact (P=0.007)) in P than in NP. These results support the view that stepping initiation in healthy subjects involves postural asymmetry. This statement may have relevant implications in clinical evaluation where postural asymmetry is generally considered as reflecting postural impairment. Copyright 2010 Elsevier B.V. All rights reserved.

A propofol microemulsion with low free propofol in the aqueous phase: formulation, physicochemical characterization, stability and pharmacokinetics.

PubMed

Cai, WeiHui; Deng, WanDing; Yang, HuiHui; Chen, XiaoPing; Jin, Fang

2012-10-15

The purpose of this study was to develop a propofol microemulsion with a low concentration of free propofol in the aqueous phase. Propofol microemulsions were prepared based on single-factor experiments and orthogonal design. The optimal microemulsion was evaluated for pH, osmolarity, particle size, zeta potential, morphology, free propofol in the aqueous phase, stability, and pharmacokinetics in beagle dogs, and comparisons made with the commercial emulsion, Diprivan(®). The pH and osmolarity of the microemulsion were similar to those of Diprivan(®). The average particle size was 22.6±0.2 nm, and TEM imaging indicated that the microemulsion particles were spherical in appearance. The concentration of free propofol in the microemulsion was 21.3% lower than that of Diprivan(®). Storage stability tests suggested that the microemulsion was stable long-term under room temperature conditions. The pharmacokinetic profile for the microemulsion showed rapid distribution and elimination compared to Diprivan(®). We conclude that the prepared microemulsion may be clinically useful as a potential carrier for propofol delivery. Copyright © 2012 Elsevier B.V. All rights reserved.

A novel ionic amphiphilic chitosan derivative as a stabilizer of nanoemulsions: Improvement of antimicrobial activity of Cymbopogon citratus essential oil.

PubMed

Bonferoni, Maria Cristina; Sandri, Giuseppina; Rossi, Silvia; Usai, Donatella; Liakos, Ioannis; Garzoni, Alice; Fiamma, Maura; Zanetti, Stefania; Athanassiou, Athanassia; Caramella, Carla; Ferrari, Franca

2017-04-01

Amphiphilic chitosans have been recently proposed to improve delivery of poorly soluble drugs. In the present paper a derivative obtained by ionic interaction between chitosan and oleic acid was for the first time studied to physically stabilize o/w nanoemulsions of an antimicrobial essential oil, Cymbopogon citratus (Lemongrass), in a low energy and mild conditions emulsification process. The novel combination of spontaneous emulsification process with chitosan oleate amphiphilic properties resulted in a stable dispersion of a few hundred nanometer droplets. Positive zeta potential confirmed the presence of a chitosan shell around the oil droplets, which is responsible for the nanoemulsion physical stabilization and for the maintenance of chitosan bioactive properties, such as mucoadhesion. Cytotoxicity test was performed on four different cell lines (HEp-2, Caco-2, WKD and McCoy cells) showing biocompatibility of the system. The maintenance and in some cases even a clear improvement in the essential oil antimicrobial activity towards nine bacterial and ten fungal strains, all of clinical relevance was verified for Lemongrass nanoemulsion. Copyright © 2017. Published by Elsevier B.V.

Developments in the formulation and delivery of spray dried vaccines

PubMed Central

Kanojia, Gaurav; Have, Rimko ten; Soema, Peter C.; Frijlink, Henderik; Amorij, Jean-Pierre; Kersten, Gideon

2017-01-01

ABSTRACT Spray drying is a promising method for the stabilization of vaccines, which are usually formulated as liquids. Usually, vaccine stability is improved by spray drying in the presence of a range of excipients. Unlike freeze drying, there is no freezing step involved, thus the damage related to this step is avoided. The edge of spray drying resides in its ability for particles to be engineered to desired requirements, which can be used in various vaccine delivery methods and routes. Although several spray dried vaccines have shown encouraging preclinical results, the number of vaccines that have been tested in clinical trials is limited, indicating a relatively new area of vaccine stabilization and delivery. This article reviews the current status of spray dried vaccine formulations and delivery methods. In particular it discusses the impact of process stresses on vaccine integrity, the application of excipients in spray drying of vaccines, process and formulation optimization strategies based on Design of Experiment approaches as well as opportunities for future application of spray dried vaccine powders for vaccine delivery. PMID:28925794

Length of stay after reaching clinical stability drives hospital costs associated with adult community-acquired pneumonia.

PubMed

Cortoos, Pieter-Jan; Gilissen, Christa; Laekeman, Gert; Peetermans, Willy E; Leenaers, Hilde; Vandorpe, Luc; Simoens, Steven

2013-03-01

Community-acquired pneumonia (CAP) has a considerable clinical and economic impact. The aim of this study was to identify drivers of hospital costs associated with CAP in 2 Belgian hospitals. Specifically, the influence of patient characteristics, quality indicators, and other treatment aspects on hospital costs was explored. The following were registered for patients admitted with a confirmed diagnosis of CAP in a large university hospital (Universitaire Ziekenhuizen Leuven, UZL) and a medium-sized secondary care hospital (Ziekenhuis Oost-Limburg, ZOL) in Belgium: the pneumonia severity index (PSI), time to clinical stability, length of stay, antibiotic therapy, outcomes, compliance with validated quality indicators, and the different costs (pharmacy, laboratory, and radiology, and total). Regression analysis was used to identify influential variables. Between October 2007 and June 2010, 803 patients were included, with a median total cost of €4794.57. The length of stay after clinical stability and time to clinical stability had the highest influence on the total cost (+6.3% and +4.9% per additional day, respectively; p < 0.0001). Other important drivers of higher costs were total therapy duration, PSI score, age, and admission to intensive care. Patients treated with moxifloxacin had significantly, but limited, lower costs. Quality indicator compliance, including guideline-compliant antibiotic treatment and therapy streamlining, had little influence. The most important driver of hospital costs associated with CAP was the time between clinical stability and actual hospital discharge. In order to substantially decrease the costs of CAP treatment, this period should be rigorously evaluated for possible intervention targets that would allow costs in CAP treatment to be decreased in a substantial manner.

Treatment of medial shoulder joint instability in dogs by extracapsular stabilization with a prosthetic ligament: 39 cases (2008-2013).

PubMed

O'Donnell, Erica M; Canapp, Sherman O; Cook, James L; Pike, Fred

2017-11-01

OBJECTIVE To investigate clinical outcomes for dogs surgically treated for medial shoulder joint instability (MSI) by extracapsular stabilization with a prosthetic ligament. DESIGN Retrospective multicenter case series. ANIMALS 39 client-owned dogs. PROCEDURES Medical records of 3 veterinary medical centers were searched to identify dogs with MSI diagnosed by clinical examination and arthroscopic assessment and treated by extracapsular stabilization with a prosthetic ligament. A minimum 6-month follow-up period was required for study inclusion. Signalment, function or use of the dog, duration of clinical signs, clinical and diagnostic imaging data, MSI grade (1 [mild] to 4 [complete luxation]), follow-up duration, complications, and outcome data were recorded. RESULTS All grades of MSI were represented. Implants were placed successfully in all dogs. Complications (4 major and 2 minor) were recorded for 6 of 39 (15%) dogs; all were treated successfully. Function at the time of last follow-up (6 to 68 months) was deemed full in 30 of 39 (77%) dogs and acceptable in 9 (23%). CONCLUSIONS AND CLINICAL RELEVANCE Surgical treatment of MSI in dogs by extracapsular stabilization with a prosthetic ligament was associated with a complication rate considered acceptable for orthopedic procedures. All patient outcomes were considered successful.

A Wind-Tunnel Parametric Investigation of Tiltrotor Whirl-Flutter Stability Boundaries

NASA Technical Reports Server (NTRS)

Piatak, David J.; Kvaternik, Raymond G.; Nixon, Mark W.; Langston, Chester W.; Singleton, Jeffrey D.; Bennett, Richard L.; Brown, Ross K.

2001-01-01

A wind-tunnel investigation of tiltrotor whirl-flutter stability boundaries has been conducted on a 1/5-size semispan tiltrotor model known as the Wing and Rotor Aeroelastic Test System (WRATS) in the NASA-Langley Transonic Dynamics Tunnel as part of a joint NASA/Army/Bell Helicopter Textron, Inc. (BHTI) research program. The model was first developed by BHTI as part of the JVX (V-22) research and development program in the 1980's and was recently modified to incorporate a hydraulically-actuated swashplate control system for use in active controls research. The modifications have changed the model's pylon mass properties sufficiently to warrant testing to re-establish its baseline stability boundaries. A parametric investigation of the effect of rotor design variables on stability was also conducted. The model was tested in both the on-downstop and off-downstop configurations, at cruise flight and hover rotor rotational speeds, and in both air and heavy gas (R-134a) test mediums. Heavy gas testing was conducted to quantify Mach number compressibility effects on tiltrotor stability. Experimental baseline stability boundaries in air are presented with comparisons to results from parametric variations of rotor pitch-flap coupling and control system stiffness. Increasing the rotor pitch-flap coupling (delta(sub 3) more negative) was found to have a destabilizing effect on stability, while a reduction in control system stiffness was found to have little effect on whirl-flutter stability. Results indicate that testing in R-134a, and thus matching full-scale tip Mach number, has a destabilizing effect, which demonstrates that whirl-flutter stability boundaries in air are unconservative.

[RESEARCH PROGRESS OF BIOMECHANICS OF PROXIMAL ROW CARPAL INSTABILITY].

PubMed

Guo, Jinhai; Huang, Fuguo

2015-01-01

To review the research progress of the biomechanics of proximal row carpal instability (IPRC). The related literature concerning IPRC was extensively reviewed. The biomechanical mechanism of the surrounding soft tissue in maintaining the stability of the proximal row carpal (PRC) was analyzed, and the methods to repair or reconstruct the stability and function of the PRC were summarized from two aspects including basic biomechanics and clinical biomechanics. The muscles and ligaments of the PRC are critical to its stability. Most scholars have reached a consensus about biomechanical mechanism of the PRC, but there are still controversial conclusions on the biomechanics mechanism of the surrounding soft tissue to stability of distal radioulnar joint when the triangular fibrocartilage complex are damaged and the biomechanics mechanism of the scapholunate ligament. At present, there is no unified standard about the methods to repair or reconstruct the stability and function of the PRC. So, it is difficult for clinical practice. Some strides have been made in the basic biomechanical study on muscle and ligament and clinical biomechanical study on the methods to repair or reconstruct the stability and function of PRC, but it will be needed to further study the morphology of carpal articular surface and the adjacent articular surface, the pressure of distal carpals to proximal carpal and so on.

Autism in the Faroe Islands: Diagnostic Stability from Childhood to Early Adult Life

PubMed Central

Kočovská, Eva; Billstedt, Eva; Ellefsen, Asa; Kampmann, Hanna; Gillberg, I. Carina; Biskupstø, Rannvá; Andorsdóttir, Guðrið; Stóra, Tormóður; Minnis, Helen; Gillberg, Christopher

2013-01-01

Childhood autism or autism spectrum disorder (ASD) has been regarded as one of the most stable diagnostic categories applied to young children with psychiatric/developmental disorders. The stability over time of a diagnosis of ASD is theoretically interesting and important for various diagnostic and clinical reasons. We studied the diagnostic stability of ASD from childhood to early adulthood in the Faroe Islands: a total school age population sample (8–17-year-olds) was screened and diagnostically assessed for AD in 2002 and 2009. This paper compares both independent clinical diagnosis and Diagnostic Interview for Social and Communication Disorders (DISCO) algorithm diagnosis at two time points, separated by seven years. The stability of clinical ASD diagnosis was perfect for AD, good for “atypical autism”/PDD-NOS, and less than perfect for Asperger syndrome (AS). Stability of the DISCO algorithm subcategory diagnoses was more variable but still good for AD. Both systems showed excellent stability over the seven-year period for “any ASD” diagnosis, although a number of clear cases had been missed at the original screening in 2002. The findings support the notion that subcategories of ASD should be collapsed into one overarching diagnostic entity with subgrouping achieved on other “non-autism” variables, such as IQ and language levels and overall adaptive functioning. PMID:23476144

Specific muscle stabilizing as home exercises for persistent pelvic girdle pain after pregnancy: a randomized, controlled clinical trial.

PubMed

Gutke, Annelie; Sjödahl, Jenny; Oberg, Birgitta

2010-11-01

To investigate the efficacy of home-based specific stabilizing exercises focusing on the local stabilizing muscles as the only intervention in the treatment of persistent postpartum pelvic girdle pain. A prospective, randomized, single-blinded, clinically controlled study. Eighty-eight women with pelvic girdle pain were recruited 3 months after delivery. The treatment consisted of specific stabilizing exercises targeting the local trunk muscles. The reference group had a single telephone contact with a physiotherapist. Primary outcome was disability measured with Oswestry Disability Index. Secondary outcomes were pain, health-related quality of life (EQ-5D), symptom satisfaction, and muscle function. No significant differences between groups could be found at 3- or 6-month follow-up regarding primary outcome in disability. Within-group comparisons showed some improvement in both groups in terms of disability, pain, symptom satisfaction and muscle function compared with baseline, although the majority still experienced pelvic girdle pain. Treatment with this home-training concept of specific stabilizing exercises targeting the local muscles was no more effective in improving consequences of persistent postpartum pelvic girdle pain than the clinically natural course. Regardless of whether treatment with specific stabilizing exercises was carried out, the majority of women still experienced some back pain almost one year after pregnancy.

Effects of Corrective Taping on Balance and Gait in Patients With Hallux Valgus.

PubMed

Gur, Gozde; Ozkal, Ozden; Dilek, Burcu; Aksoy, Songul; Bek, Nilgun; Yakut, Yavuz

2017-05-01

Taping is an effective temporary therapy for improving hallux valgus (HV) in adults. Although HV has been demonstrated to impair postural balance, there is a lack of information about how corrective taping affects balance and gait patterns in adults with HV deformity. Eighteen middle-aged female patients (average age, 53.5 years) with HV were included. Corrective tape was applied to correct HV angulation. A series of balance and gait stability tests were performed before applying tape and 1 hour after the tape was applied with a Balance Master computerized posturography device. The study involved the following tests: modified clinical test of sensory interaction and balance (mCTSIB), unilateral stance (US), limit of stability (LoS), step up/over (SUO), and walk across (WA) tests. No significant difference was found between the no-tape and taped condition in the static balance mCTSIB and US tests ( P > .05). The taping intervention resulted in significant improvement in the dynamic balance measures for the LoS test's backward reaction time and left maximum excursion ( P < .05), a significantly higher impact index bilaterally in the SUO assessment ( P < .05), and an increase in step width mean and variability in the WA test ( P < .05). Taping for correcting HV angulation had negative acute effects on dynamic balance in the SUO and WA tests and positive effects in the LoS test. Corrective taping, although a form of conservative treatment for hallux valgus, has been insufficiently studied in terms of effects on balance. Our results show that taping, as an acute effect, may impair balance in middle-aged adults when walking or ascending and descending stairs.

A Clinical Evaluation Denture Adhesives Used by Patients With Xerostomia

PubMed Central

Bogucki, Zdzislaw A.; Napadlek, Piotr; Dabrowa, Tomasz

2015-01-01

Abstract The purpose of study was to analyze the participants’ opinions concerning the effectiveness of 6 denture adhesives (DA). The study group included 60 participants. Criteria for selecting the patients were as follows: reduced retention and stabilization of maxillary complete dentures and xerostomia. These features were evaluated on basis of clinical examination and standard sialometry tests (u-SFR). Retention of maxillary dentures was scored by modified Kapur index before application of DA. All participants were divided randomly into 6 groups regarding the use of the 6 DA during a 6-month period. After this time, participants completed an HRQL questionnaire. DA noticeably improved retention and stabilization of maxillary complete dentures. DA in the glue form had the best retention effectiveness in participants with xerostomia. These materials are difficult to clean from the denture base. The data are presented in tables and figures. The results of the study collected positive influence of adhesives on retention of dentures in xerostomia patients. The cleaning dentures and denture bearing tissues was difficult. DA help in the use of prostheses, but it is also necessary for the treatment of the causes and symptoms of xerostomia. PMID:25700320

Physicochemical and biological characterization of 1E10 Anti-Idiotype vaccine

PubMed Central

2011-01-01

Background 1E10 monoclonal antibody is a murine anti-idiotypic antibody that mimics N-glycolyl-GM3 gangliosides. This antibody has been tested as an anti-idiotypic cancer vaccine, adjuvated in Al(OH)3, in several clinical trials for melanoma, breast, and lung cancer. During early clinical development this mAb was obtained in vivo from mice ascites fluid. Currently, the production process of 1E10 is being transferred from the in vivo to a bioreactor-based method. Results Here, we present a comprehensive molecular and immunological characterization of 1E10 produced by the two different production processes in order to determine the impact of the manufacturing process in vaccine performance. We observed differences in glycosylation pattern, charge heterogeneity and structural stability between in vivo-produced 1E10 and bioreactor-obtained 1E10. Interestingly, these modifications had no significant impact on the immune responses elicited in two different animal models. Conclusions Changes in 1E10 primary structure like glycosylation; asparagine deamidation and oxidation affected 1E10 structural stability but did not affect the immune response elicited in mice and chickens when compared to 1E10 produced in mice. PMID:22108317

Development of a personal digital assistant-based wireless application in clinical practice.

PubMed

Chen, Yen-Cheng; Chiu, Hou-Chang; Tsai, Ming-Dar; Chang, Hang; Chong, Chee-Fah

2007-02-01

Our study aims to develop a personal digital assistant (PDA)-based wireless application in medical information processing by using Bluetooth and IEEE 802.11b wireless standards and SyncML codes. In this study, an "integrated database access module" is used to provide a unified integrated access interface while consistency of wireless data transmission is achieved by using the standardized SyncML protocol. A prototype of the system has been developed, implemented, and tested for its mobility, usability, stability, and performance with questionnaire survey. Response time for browsing/searching was usually less than 3s. The average time intervals needed for data transmissions were 68.6+/-8.5s for Bluetooth and 47.0+/-4.8s for 802.11b. The five-point Likert scale (from 1=least to 5=most) questionnaire survey of 30 medical professionals yielded a high degree of satisfaction with the system's mobility (4.18+/-0.89), usability (4.69+/-0.90), stability (3.81+/-0.94), and performance (3.97+/-0.88). The results of our study suggested that PDA applications which exploit wireless communication are convenient and feasible in clinical practice.

Towards frameless maskless SRS through real-time 6DoF robotic motion compensation.

PubMed

Belcher, Andrew H; Liu, Xinmin; Chmura, Steven; Yenice, Kamil; Wiersma, Rodney D

2017-11-13

Stereotactic radiosurgery (SRS) uses precise dose placement to treat conditions of the CNS. Frame-based SRS uses a metal head ring fixed to the patient's skull to provide high treatment accuracy, but patient comfort and clinical workflow may suffer. Frameless SRS, while potentially more convenient, may increase uncertainty of treatment accuracy and be physiologically confining to some patients. By incorporating highly precise robotics and advanced software algorithms into frameless treatments, we present a novel frameless and maskless SRS system where a robot provides real-time 6DoF head motion stabilization allowing positional accuracies to match or exceed those of traditional frame-based SRS. A 6DoF parallel kinematics robot was developed and integrated with a real-time infrared camera in a closed loop configuration. A novel compensation algorithm was developed based on an iterative closest-path correction approach. The robotic SRS system was tested on six volunteers, whose motion was monitored and compensated for in real-time over 15 min simulated treatments. The system's effectiveness in maintaining the target's 6DoF position within preset thresholds was determined by comparing volunteer head motion with and without compensation. Comparing corrected and uncorrected motion, the 6DoF robotic system showed an overall improvement factor of 21 in terms of maintaining target position within 0.5 mm and 0.5 degree thresholds. Although the system's effectiveness varied among the volunteers examined, for all volunteers tested the target position remained within the preset tolerances 99.0% of the time when robotic stabilization was used, compared to 4.7% without robotic stabilization. The pre-clinical robotic SRS compensation system was found to be effective at responding to sub-millimeter and sub-degree cranial motions for all volunteers examined. The system's success with volunteers has demonstrated its capability for implementation with frameless and maskless SRS treatments, potentially able to achieve the same or better treatment accuracies compared to traditional frame-based approaches.

Intraoral radiographs texture analysis for dental implant planning.

PubMed

Mundim, Mayara B V; Dias, Danilo R; Costa, Ronaldo M; Leles, Cláudio R; Azevedo-Marques, Paulo M; Ribeiro-Rotta, Rejane F

2016-11-01

Computer vision extracts features or attributes from images improving diagnosis accuracy and aiding in clinical decisions. This study aims to investigate the feasibility of using texture analysis of periapical radiograph images as a tool for dental implant treatment planning. Periapical radiograph images of 127 jawbone sites were obtained before and after implant placement. From the superimposition of the pre- and post-implant images, four regions of interest (ROI) were delineated on the pre-implant images for each implant site: mesial, distal and apical peri-implant areas and a central area. Each ROI was analysed using Matlab® software and seven image attributes were extracted: mean grey level (MGL), standard deviation of grey levels (SDGL), coefficient of variation (CV), entropy (En), contrast, correlation (Cor) and angular second moment (ASM). Images were grouped by bone types-Lekholm and Zarb classification (1,2,3,4). Peak insertion torque (PIT) and resonance frequency analysis (RFA) were recorded during implant placement. Differences among groups were tested for each image attribute. Agreement between measurements of the peri-implant ROIs and overall ROI (peri-implant + central area) was tested, as well as the association between primary stability measures (PIT and RFA) and texture attributes. Differences among bone type groups were found for MGL (p = 0.035), SDGL (p = 0.024), CV (p < 0.001) and En (p < 0.001). The apical ROI showed a significant difference from the other regions for all attributes, except Cor. Concordance correlation coefficients were all almost perfect (ρ > 0.93), except for ASM (ρ = 0.62). Texture attributes were significantly associated with the implant stability measures. Texture analysis of periapical radiographs may be a reliable non-invasive quantitative method for the assessment of jawbone and prediction of implant stability, with potential clinical applications. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Towards frameless maskless SRS through real-time 6DoF robotic motion compensation

NASA Astrophysics Data System (ADS)

Belcher, Andrew H.; Liu, Xinmin; Chmura, Steven; Yenice, Kamil; Wiersma, Rodney D.

2017-12-01

Stereotactic radiosurgery (SRS) uses precise dose placement to treat conditions of the CNS. Frame-based SRS uses a metal head ring fixed to the patient’s skull to provide high treatment accuracy, but patient comfort and clinical workflow may suffer. Frameless SRS, while potentially more convenient, may increase uncertainty of treatment accuracy and be physiologically confining to some patients. By incorporating highly precise robotics and advanced software algorithms into frameless treatments, we present a novel frameless and maskless SRS system where a robot provides real-time 6DoF head motion stabilization allowing positional accuracies to match or exceed those of traditional frame-based SRS. A 6DoF parallel kinematics robot was developed and integrated with a real-time infrared camera in a closed loop configuration. A novel compensation algorithm was developed based on an iterative closest-path correction approach. The robotic SRS system was tested on six volunteers, whose motion was monitored and compensated for in real-time over 15 min simulated treatments. The system’s effectiveness in maintaining the target’s 6DoF position within preset thresholds was determined by comparing volunteer head motion with and without compensation. Comparing corrected and uncorrected motion, the 6DoF robotic system showed an overall improvement factor of 21 in terms of maintaining target position within 0.5 mm and 0.5 degree thresholds. Although the system’s effectiveness varied among the volunteers examined, for all volunteers tested the target position remained within the preset tolerances 99.0% of the time when robotic stabilization was used, compared to 4.7% without robotic stabilization. The pre-clinical robotic SRS compensation system was found to be effective at responding to sub-millimeter and sub-degree cranial motions for all volunteers examined. The system’s success with volunteers has demonstrated its capability for implementation with frameless and maskless SRS treatments, potentially able to achieve the same or better treatment accuracies compared to traditional frame-based approaches.

Evaluation of accelerated stability test conditions for medicated chewing gums.

PubMed

Maggi, Lauretta; Conte, Ubaldo; Nhamias, Alain; Grenier, Pascal; Vergnault, Guy

2013-10-01

The overall stability of medicated chewing gums is investigated under different storage conditions. Active substances with different chemical stabilities in solid state are chosen as model drugs. The dosage form is a three layer tablet obtained by direct compression. The gum core contains the active ingredient while the external layers are formulated to prevent gum adhesion to the punches of the tableting machine. Two accelerated test conditions (40°C/75% RH and 30°C/65% RH) are performed for 6 months. Furthermore, a long-term stability test at room conditions is conducted to verify the predictability of the results obtained from the stress tests. Some drugs are stable in all the conditions tested, but other drugs, generally considered stable in solid dosage forms, have shown relevant stability problems particularly when stress test conditions are applied to this particular semi-solid dosage forms. For less stable drugs, the stress conditions of 40°C/75% RH are not always predictable of chewing gum stability at room temperature and may produce false negative; intermediate conditions, 30°C/65% RH, are more predictive for this purpose, the results of drug content found after 6 months at intermediate stress conditions and 12 months at room conditions are generally comparable. But the results obtained show that only long-term conditions stability tests gave consistent results. During aging, the semi solid nature of the gum base itself, may also influence the drug delivery rate during chewing and great attention should be given also to the dissolution stability.

Shear Bond Strengths between Three Different Yttria-Stabilized Zirconia Dental Materials and Veneering Ceramic and Their Susceptibility to Autoclave Induced Low-Temperature Degradation.

PubMed

Sehgal, Manoti; Bhargava, Akshay; Gupta, Sharad; Gupta, Prateek

2016-01-01

A study was undertaken to evaluate the effect of artificial aging through steam and thermal treatment as influencing the shear bond strength between three different commercially available zirconia core materials, namely, Upcera, Ziecon, and Cercon, layered with VITA VM9 veneering ceramic using Universal Testing Machine. The mode of failure between zirconia and ceramic was further analyzed as adhesive, cohesive, or mixed using stereomicroscope. X-ray diffraction and SEM (scanning electron microscope) analysis were done to estimate the phase transformation (m-phase fraction) and surface grain size of zirconia particles, respectively. The purpose of this study was to simulate the clinical environment by artificial aging through steam and thermal treatment so as the clinical function and nature of the bond between zirconia and veneering material as in a clinical trial of 15 years could be evaluated.

Initial validation of the Personality Assessment Inventory-Spanish version with clients from Mexican American communities.

PubMed

Rogers, R; Flores, J; Ustad, K; Sewell, K W

1995-04-01

Psychological assessment of Hispanic populations are thwarted by the absence of clinical research on comparability of Spanish translations and the stability of their findings. In this study we examined the potential usefulness of the Spanish Personality Assessment Inventory (PAI; Morey, 1991) for Hispanic clients residing in Mexican American communities. We administered the Spanish version on two occasions to 48 monolingual clients and the Spanish and English versions to 21 bilingual clients. Results indicated that the clinical scales had a moderate to good correspondence for Spanish-English (M r = .72) and good test-retest reliability for Spanish-Spanish (M r = .79). Much more variation was observed for the validity scales and the treatment/interpersonal scales. Also more variability was observed in the convergence of elevations across administrations. Because of these mixed results, we discuss the potential usefulness of the PAI clinical scales to screen for major psychopathology.

Biomechanical comparison of two surgical techniques for press-fit reconstruction of the posterolateral complex of the knee.

PubMed

Panzica, Martin; Janzik, Janne; Bobrowitsch, Evgenij; Krettek, Christian; Hawi, Nael; Hurschler, Christof; Jagodzinski, Michael

2015-11-01

To date, various surgical techniques to treat posterolateral knee instability have been described. Recent studies recommended an anatomical and isometric reconstruction of the posterolateral corner addressing the key structures, such as lateral collateral ligament (LCL), popliteus tendon (POP) and popliteofibular ligament (PFL). Two clinical established autologous respective local reconstruction methods of the posterolateral complex were tested for knot-bone cylinder press-fit fixation to assess efficacy of each reconstruction technique in comparison to the intact knee. The knot-bone cylinder press-fit fixation for both anatomic and isometric reconstruction techniques of the posterolateral complex shows equal biomechanical stability as the intact posterolateral knee structures. This was a controlled laboratory study. Two surgical techniques (Larson: fibula-based semitendinosus autograft for LCL and PFL reconstruction/Kawano: biceps femoris and iliotibial tract autograft for LCL, PFL and POP reconstruction) with press-fit fixation were used for restoration of posterolateral knee stability. Seven cadaveric knees (66 ± 3.4 years) were tested under three conditions: intact knee, sectioned state and reconstructed knee for each surgical technique. Biomechanical stress tests were performed for every state at 30° and 90° knee flexion for anterior-posterior translation (60 N), internal-external and varus-valgus rotation (5 Nm) at 0°, 30° and 90° using a kinemator (Kuka robot). At 30° and 90° knee flexion, no significant differences between the four knee states were registered for anterior-posterior translation loading. Internal-external and varus-valgus rotational loading showed significantly higher instability for the sectioned state than for the intact or reconstructed posterolateral structures (p < 0.05). There were no significant differences between the intact and reconstructed knee states for internal-external rotation, varus-valgus rotation and anterior-posterior translation at any flexion angles (p > 0.05). Comparing both reconstruction techniques, significant higher varus-/valgus stability was registered for the fibula-based Larson technique at 90° knee flexion (p < 0.05). Both PLC reconstructions showed equal biomechanical stability as the intact posterolateral knee structures when using knot-bone cylinder press-fit fixation. We registered restoration of the rotational and varus-valgus stability with both surgical techniques. The anterior-posterior translational stability was not influenced significantly. The Larson technique showed significant higher varus/valgus stability in 90° flexion. The latter is easier to perform and takes half the preparation time, but needs grafting of the semitendinosus tendon. The Kawano reconstruction technique is an interesting alternative in cases of missing autografts.

Stability of local anesthetics in the dental cartridge.

PubMed

Hondrum, S O; Seng, G F; Rebert, N W

1993-01-01

Recent manufacturer recalls of local anesthetics have emphasized the problems with storage stability. This article reviews the principles of drug stability, mechanisms of degradation of commonly used vasoconstrictors, research on the stability of commercially produced local anesthetic preparations, and possible effects of the container-closure system. The review concludes with a list of practical and clinical suggestions on how to minimize storage stability problems with dental local anesthetics.

Techniques for Liquid Rocket Combustion Spontaneous Stability and Rough Combustion Assessments

NASA Technical Reports Server (NTRS)

Kenny, R. J.; Giacomoni, C.; Casiano, M. J.; Fischbach, S. R.

2016-01-01

This work presents techniques for liquid rocket engine combustion stability assessments with respect to spontaneous stability and rough combustion. Techniques covering empirical parameter extraction, which were established in prior works, are applied for three additional programs: the F-1 Gas Generator (F1GG) component test program, the RS-84 preburner component test program, and the Marshall Integrated Test Rig (MITR) program. Stability assessment parameters from these programs are compared against prior established spontaneous stability metrics and updates are identified. Also, a procedure for comparing measured with predicted mode shapes is presented, based on an extension of the Modal Assurance Criterion (MAC).

Failure to account for practice effects leads to clinical misinterpretation of cognitive outcome following carotid endarterectomy.

PubMed

Marley, Christopher J; Sinnott, Andrew; Hall, Judith E; Morris-Stiff, Gareth; Woodsford, Paul V; Lewis, Michael H; Bailey, Damian M

2017-06-01

Carotid endarterectomy (CEA) is a surgical procedure to remove stenotic atherosclerotic plaque from the origin of the carotid artery to reduce the risk of major stroke. Its impact on postoperative cognitive function (POCF) remains controversial; complicated, in part, by a traditional failure to account for practice effects incurred during consecutive psychometric testing. To address this for the first time, we performed psychometric testing (learning and memory, working memory, attention and information processing, and visuomotor coordination) in 15 male patients aged 68  ±  8 years with symptomatic carotid stenosis the day before and 24 h following elective CEA (two consecutive tests, 48 h apart). Multiple baselining was also performed in a separate cohort of 13 educationally, anthropometrically and age-matched controls (63  ±  9 years) not undergoing revascularization at identical time points with additional measures performed over a further 96 h (four consecutive tests, each 48 h apart). A single consecutive test in the control group resulted in progressive improvements in learning and memory, working memory, and attention and information ( P  <   0.05 vs. Test 1), with three tests required before cognitive performance stabilized. Following correction for practice effects in the patient group, CEA was associated with a deterioration rather than an improvement in learning and memory as originally observed ( P  <   0.05). These findings highlight the potential for the clinical misinterpretation of POCF unless practice effects are taken into account and provide practical recommendations for implementation within the clinical setting. © 2017 The Authors. Physiological Reports published by Wiley Periodicals, Inc. on behalf of The Physiological Society and the American Physiological Society.

[Design and validation of a questionnaire to assess the level of general knowledge on eating disorders in students of Health Sciences].

PubMed

Sánchez Socarrás, Violeida; Aguilar Martínez, Alicia; Vaqué Crusellas, Cristina; Milá Villarroel, Raimon; González Rivas, Fabián

2016-01-01

To design and validate a questionnaire to assess the level of knowledge regarding eating disorders in college students. Observational, prospective, and longitudinal study, with the design of the questionnaire based on a conceptual review and validation by a cognitive pre-test and pilot test-retest, with analysis of the psychometric properties in each application. University Foundation of Bages, Barcelona. Marco community care. A total of 140 students from Health Sciences; 53 women and 87 men with a mean age of 21.87 years; 28 participated in the pre-test and 112 in the test-retests, 110 students completed the study. Validity and stability study using Cronbach α and Pearson product-moment correlation coefficient statistics; relationship skills with sex and type of study, non-parametric statistical Mann-Whitney and Kruskal-Wallis tests; for demographic variables, absolute or percentage frequencies, as well as mean, central tendency and standard deviation as measures of dispersion were calculated. The statistical significance level was 95% confidence. The questionnaire was obtained that had 10 questions divided into four dimensions (classification, demographics characteristics of patients, risk factors and clinical manifestations of eating disorders). The scale showed good internal consistency in its final version (Cronbach α=0.724) and adequate stability (Pearson correlation 0.749). The designed tool can be accurately used to assess Health Sciences students' knowledge of eating disorders. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

Effect of footwear on standing balance in healthy young adult males

PubMed Central

Alghadir, Ahmad H.; Zafar, Hamayun; Anwer, Shahnawaz

2018-01-01

Objective: The present study aimed to evaluate the effect of footwear on standing balance in healthy young adult males. Methods: Thirty healthy male participants aged 20-30 years were tested for standing balance on the Balance Master on three occasions, including wearing a sandal, standard shoe, or no footwear (barefoot). The tests of postural stability include; “Modified Clinical Test of Sensory Interaction on Balance” (mCTSIB), “Unilateral Stance” (US), and the “Limits of Stability” (LOS). The balance scores (mCTSIB, US, and LOS) was analyzed. Results: There was a significant effect between footwear conditions for mCTIB with eye closed on a firm surface (p=0.002). There was a significant effect between footwear conditions for the US with eye open and closed (p<0.05). There was a significant effect between footwear conditions for LOS reaction time during forward movement (p=0.02). Similarly, there was a significant effect between footwear conditions for LOS reaction time during left side movement (p=0.01). Conclusions: Wearing sandals compared to bare feet significantly increased postural sway and reduced stability in healthy young adult males. However, wearing a standard shoe compared to bare feet did not significantly affect balance scores in standing. PMID:29504581

Posture and equilibrium in orthopedic and rheumatologic diseases.

PubMed

Missaoui, B; Portero, P; Bendaya, S; Hanktie, O; Thoumie, P

2008-12-01

Posture and balance may be affected in many spine or lower-limb disorders. An extensive evaluation including clinical tests and movement analysis techniques may be necessary to characterize how rheumatologic or orthopedic diseases are related to static or dynamic changes in postural control. In lower limbs, unbalance may be related to a decreased stability following arthrosis or ligament injuries at knee or ankle levels, while hip lesions appear less associated with such troubles. Spinal diseases at cervical level are frequently associated with postural changes and impaired balance control, related to the major role of sensory inputs during stance and gait. At lower levels, changes are noticed in major scoliosis and may be related to pain intensity in patients with chronic low-back pain. Whatever the initial lesion and the affected level, improvement in clinical or instrumental tests following rehabilitation or brace wearing provides argument for a close relationship between rheumatologic or orthopedic diseases and related impairments in posture and balance control.

Development and Testing of a High Stability Engine Control (HISTEC) System

NASA Technical Reports Server (NTRS)

Orme, John S.; DeLaat, John C.; Southwick, Robert D.; Gallops, George W.; Doane, Paul M.

1998-01-01

Flight tests were recently completed to demonstrate an inlet-distortion-tolerant engine control system. These flight tests were part of NASA's High Stability Engine Control (HISTEC) program. The objective of the HISTEC program was to design, develop, and flight demonstrate an advanced integrated engine control system that uses measurement-based, real-time estimates of inlet airflow distortion to enhance engine stability. With improved stability and tolerance of inlet airflow distortion, future engine designs may benefit from a reduction in design stall-margin requirements and enhanced reliability, with a corresponding increase in performance and decrease in fuel consumption. This paper describes the HISTEC methodology, presents an aircraft test bed description (including HISTEC-specific modifications) and verification and validation ground tests. Additionally, flight test safety considerations, test plan and technique design and approach, and flight operations are addressed. Some illustrative results are presented to demonstrate the type of analysis and results produced from the flight test program.

SU-C-BRB-04: Characteristics and Performance Evaluation of the First Commercial MLC for a Robotic Delivery System

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

Fuerweger, C; European Cyberknife Center Munich, Munich, DE; Prins, P

Purpose: To assess characteristics and performance of the “Incise™” MLC (41 leaf pairs, 2.5mm width, FFF linac) mounted on the robotic SRS/SBRT platform “CyberKnife M6™” in a pre-clinical 5 months (11/2014–03/2015) test period. Methods: Beam properties were measured with unshielded diodes and EBT3 film. The CyberKnife workspace for MLC was analyzed by transforming robot node coordinates (cranial / body paths) into Euler geometry. Bayouth tests for leaf / bank position accuracy were performed in standard (A/P) and clinically relevant non-standard positions, before and after exercising the MLC for 10+ minutes. Total system and delivery accuracy were assessed in End-to-End testsmore » and dosimetric verification of exemplary plans. Stability over time was evaluated in Picket-Fence-and adapted Winston-Lutz-tests (AQA) for different collimator angles. Results: Penumbrae (80–20%, with 100%=2*dose at inflection point; SAD 80cm; 10cm depth) parallel / perpendicular to leaf motion were 2.87/2.64mm for the smallest (0×76×0.75cm{sup 2}) and 5.34/4.94mm for the largest (9.76×9.75cm{sup 2}) square field. MLC circular field penumbrae exceeded fixed cones by 10–20% (e.g. 60mm: 4.0 vs. 3.6mm; 20mm: 3.6 vs. 2.9mm). Interleaf leakage was <0.5%. Clinically accessible workspace with MLC covered (non-coplanar) gantry angles of [-113°;+112°] (cranial) and [-108°;+102°] (body), and collimator angles of [-100°;+107°] (cranial) and [-91°;+100°] (body). Average leaf position offsets were ≤0.2mm in 14 standard A/P Bayouth tests and ≤0.6mm in 8 non-standard direction tests. Pre-test MLC exercise increased jaggedness (range ±0.3mm vs. ±0.5mm) and allowed to identify one malfunctioning leaf motor. Total system accuracy with MLC was 0.39±0.06mm in 6 End-to-End tests. Picket-Fence and AQA showed no adverse trends during the test period. Conclusion: The Incise™ MLC for CyberKnife M6™ displayed high accuracy and mechanical stability over the test period. The specific CyberKnife geometry and performance after exercise demand dedicated QA measures. This work is in part funded by a research grant from Accuray Inc, Sunnyvale, USA. Erasmus MC Cancer Institute also has research collaborations with Elekta AB, Stockholm, Sweden. C Fuerweger has previously received speaker honoraria from Accuray Inc, Sunnyvale, USA.« less

Concentrations and stability of methyl methacrylate, glutaraldehyde, formaldehyde and nickel sulfate in commercial patch test allergen preparations.

PubMed

Siegel, Paul D; Fowler, Joseph F; Law, Brandon F; Warshaw, Erin M; Taylor, James S

2014-05-01

Epicutaneous patch tests are used to reproduce allergy and diagnose allergic contact dermatitis. Reliable allergen test preparations are required. The purpose of the present study was to measure the actual concentrations of nickel(II) sulfate hexahydrate (NiSO4 ), methyl methacrylate, formaldehyde, and glutaraldehyde, and to compare them with the labelled concentrations, in commercial patch test allergen preparations found in dermatology clinics where patch testing is routinely performed. The commercial in-date and out-of-date patch test allergen preparations concentrations of NiSO4 , methyl methacrylate, formaldehyde and glutaraldehyde from one to three participating clinics were analysed with chromatographic or wet chemical techniques. NiSO4 and formaldehyde concentrations were at or above the labelled concentrations; however, formaldehyde loss occurred with storage. NiSO4 particulate was uniformly distributed throughout the petrolatum. 'In-use' methyl methacrylate reagent syringes all contained ≤ 56% of the 2% label concentration, with no observable relationship with expiration date. Lower methyl methacrylate cocentrations were consistently measured at the syringe tip end, suggesting loss resulting from methyl methacrylate's volatility. The concentrations of glutaraldehyde patch test allergen preparations ranged from 27% to 45% of the labelled (1% in pet.) concentration, independently of expiration date. Some false-negative methyl methacrylate, formaldehyde or glutaraldehyde patch test results may be attributable to instability of the test preparations. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Stability testing and analysis of a PMAD dc test bed for the Space Station Freedom

NASA Technical Reports Server (NTRS)

Button, Robert M.; Brush, Andrew S.

1992-01-01

The Power Management and Distribution (PMAD) dc Test Bed at the NASA Lewis Research Center is introduced. Its usefulness to the Space Station Freedom Electrical Power (EPS) development and design are discussed in context of verifying system stability. Stability criteria developed by Middlebrook and Cuk are discussed as they apply to constant power dc to dc converters exhibiting negative input impedance at low frequencies. The utility-type Secondary Subsystem is presented and each component is described. The instrumentation used to measure input and output impedance under load is defined. Test results obtained from input and output impedance measurements of test bed components are presented. It is shown that the PMAD dc Test Bed Secondary Subsystem meets the Middlebrook stability criterion for certain loading conditions.

Stability Testing and Analysis of a PMAD DC Test Bed for the Space Station Freedom

NASA Technical Reports Server (NTRS)

Button, Robert M.; Brush, Andrew S.

1992-01-01

The Power Management and Distribution (PMAD) DC Test Bed at the NASA Lewis Research Center is introduced. Its usefulness to the Space Station Freedom Electrical Power (EPS) development and design are discussed in context of verifying system stability. Stability criteria developed by Middlebrook and Cuk are discussed as they apply to constant power DC to DC converters exhibiting negative input impedance at low frequencies. The utility-type Secondary Subsystem is presented and each component is described. The instrumentation used to measure input and output impedance under load is defined. Test results obtained from input and output impedance measurements of test bed components are presented. It is shown that the PMAD DC Test Bed Secondary Subsystem meets the Middlebrook stability criterion for certain loading conditions.

Reliability and Concurrent Validity of Dynamic Rotator Stability Test-A Cross Sectional study.

PubMed

Binoy Mathew, K V; Eapen, Charu; Kumar, P Senthil

2012-01-01

To find intra rater and inter rater reliability of Dynamic Rotator Stability Test (DRST) and to find concurrent validity of Dynamic Rotator Stability Test (DRST) with University of Pennsylvania Shoulder Score (PENN) Scale. 40 subjects of either gender between the age group of 18-70 with painful shoulder conditions of musculoskeletal origin was selected through convenient sampling. Tester 1 and tester 2 administered DRST and PENN scale randomly. In a subgroup of 20 subjects DRST was administered by both the testers to find the inter rater reliability. 180° Standard Universal Goniometer was used to take measurements. For intra-rater reliability, all the test variables were showing highly significant correlation (p=.94 - 1). For inter -rater, with tester 2, test variables like position, ROM, force, direction of abnormal translation, pain during the test, compensatory movement during test were found to be significant (p=.71-1).only some variables of DRST showed significant correlation with PENN scale (P=.320-.450). Dynamic Rotator Stability Test has good intra rater and moderate inter rater reliability. Concurrent validity of Dynamic Rotator Stability Test was found to be poor when compared to PENN Shoulder Score.

What domains of clinical function should be assessed after sport-related concussion? A systematic review.

PubMed

Feddermann-Demont, Nina; Echemendia, Ruben J; Schneider, Kathryn J; Solomon, Gary S; Hayden, K Alix; Turner, Michael; Dvořák, Jiří; Straumann, Dominik; Tarnutzer, Alexander A

2017-06-01

Sport-related concussion (SRC) is a clinical diagnosis made after a sport-related head trauma. Inconsistency exists regarding appropriate methods for assessing SRC, which focus largely on symptom-scores, neurocognitive functioning and postural stability. Systematic literature review. MEDLINE, EMBASE, PsycINFO, Cochrane-DSR, Cochrane CRCT, CINAHL, SPORTDiscus (accessed July 9, 2016). Original (prospective) studies reporting on postinjury assessment in a clinical setting and evaluation of diagnostic tools within 2 weeks after an SRC. Forty-six studies covering 3284 athletes were included out of 2170 articles. Only the prospective studies were considered for final analysis (n=33; 2416 athletes). Concussion diagnosis was typically made on the sideline by an (certified) athletic trainer (55.0%), mainly on the basis of results from a symptom-based questionnaire. Clinical domains affected included cognitive, vestibular and headache/migraine. Headache, fatigue, difficulty concentrating and dizziness were the symptoms most frequently reported. Neurocognitive testing was used in 30/33 studies (90.9%), whereas balance was assessed in 9/33 studies (27.3%). The overall quality of the studies was considered low. The absence of an objective, gold standard criterion makes the accurate diagnosis of SRC challenging. Current approaches tend to emphasise cognition, symptom assessment and postural stability with less of a focus on other domains of functioning. We propose that the clinical assessment of SRC should be symptom based and interdisciplinary. Whenever possible, the SRC assessment should incorporate neurological, vestibular, ocular motor, visual, neurocognitive, psychological and cervical aspects. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Effect of core stabilization exercises versus conventional exercises on pain and functional status in patients with non-specific low back pain: a randomized clinical trial.

PubMed

Inani, Sumit B; Selkar, Sohan P

2013-01-01

Low Back Pain (LBP) results in significant level of disability, producing significant restriction on usual activity such as an inability to work. Nearly two third of the adults are affected by non-specific low back pain at some point in their lives. The purpose of the study was to determine the effect of core stabilization exercises in comparison with conventional exercises on pain, functional status in patients with non-specific LBP. Thirty patients diagnosed with non-specific LBP participated with age group between 20-50 years and divided in to 2 groups, one with core stabilization exercises and other conventional exercises, 15 subjects each. Three months study, pre and post treatment outcome measures used were VAS for pain intensity and Modified Oswestry Low Back Pain Disability Index for functional status (disability). Data were analyzed using student 't' test (paired and unpaired). Whereas both groups improved significantly from the initiation of treatment, a between-group comparison revealed significantly greater (p<0.001) improvements regarding pain and functional status for experimental group compared to control group. Core stabilization exercises were found to be more effective in reducing pain and improving functional status by decreasing disability of patients with non-specific low back pain in comparison with conventional exercises.

Cement kiln dust stabilized test section on I-96/I-75 in Wayne County : construction report : CS 82194 JN 37795 NB I-75 from Vernor Highway to Michigan Avenue, Detroit, Michigan.

DOT National Transportation Integrated Search

2010-05-01

In the summer of 2008 two CKD stabilization test sections were constructed on the I-75/I-96 Gateway roadway : reconstruction project in Detroit near the Ambassador Bridge. : Through observation and testing, CKD adequately stabilized both subgrade tes...

Development and flight test evaluation of a pitch stability augmentation system for a relaxed stability L-1011

NASA Technical Reports Server (NTRS)

Rising, J. J.

1982-01-01

The L-1011 has been flight tested to demonstrate the relaxed static stability concept as a means of obtaining significant drag benefits to achieve a more energy efficient transport. Satisfactory handling qualities were maintained with the design of an active control horizontal tail for stability and control augmentation to allow operation of the L-1011 at centers of gravity close to the neutral point. Prior to flight test, a motion base visual flight simulator program was performed to optimize the augmentation system. The system was successfully demonstrated in a test program totaling forty-eight actual flight hours.

Osteoblastic differentiating potential of dental pulp stem cells in vitro cultured on a chemically modified microrough titanium surface.

PubMed

DE Colli, Marianna; Radunovic, Milena; Zizzari, Vincenzo L; DI Giacomo, Viviana; DI Nisio, Chiara; Piattelli, Adriano; Calvo Guirado, José L; Zavan, Barbara; Cataldi, Amelia; Zara, Susi

2018-03-30

Titanium surface modification is critical for dental implant success. Our aim was to determine surfaces influence on dental pulp stem cells (DPSCs) viability and differentiation. Implants were divided into sandblasted/acid-etched (control) and sandblasted/acid-etched coated with calcium and magnesium ions (CaMg), supplied as composite (test). Proliferation was evaluated by MTT, differentiation checking osteoblastic gene expression, PGE2 secretion and matrix formation, inflammation by Interleukin 6 (IL-6) detection. MTT and IL-6 do not modify on test. A PGE2 increase on test is recorded. BMP2 is higher on test at early experimental points, Osterix and RUNX2 augment later. Alizarin-red S reveals higher matrix production on test. These results suggest that test surface is more osteoinductive, representing a start point for in vivo studies aiming at the construction of more biocompatible dental implants, whose integration and clinical performance are improved and some undesired effects, such as implant stability loss and further surgical procedures, are reduced.

High Stability Engine Control (HISTEC) Flight Test Results

NASA Technical Reports Server (NTRS)

Southwick, Robert D.; Gallops, George W.; Kerr, Laura J.; Kielb, Robert P.; Welsh, Mark G.; DeLaat, John C.; Orme, John S.

1998-01-01

The High Stability Engine Control (HISTEC) Program, managed and funded by the NASA Lewis Research Center, is a cooperative effort between NASA and Pratt & Whitney (P&W). The program objective is to develop and flight demonstrate an advanced high stability integrated engine control system that uses real-time, measurement-based estimation of inlet pressure distortion to enhance engine stability. Flight testing was performed using the NASA Advanced Controls Technologies for Integrated Vehicles (ACTIVE) F-15 aircraft at the NASA Dryden Flight Research Center. The flight test configuration, details of the research objectives, and the flight test matrix to achieve those objectives are presented. Flight test results are discussed that show the design approach can accurately estimate distortion and perform real-time control actions for engine accommodation.

Laboratory manager's financial handbook. The laboratory's importance to the financial stability of a health-care organization.

PubMed

Travers, E M

1996-01-01

From a financial standpoint, one of the most valuable assets in the survival of a health-care organization is the clinical laboratory. Laboratory directors, managers, and supervisors have indicated their overwhelming need to understand finance, especially cost management, to CLMA and to the author at national meetings and workshops, Tremendous financial pressures are being applied in health-care organizations across the country. Two strategic factors in their successful move into the 21st century are more appropriate test utilization and cost control in the laboratory.

The availability of diltiazem: a study on the sorption by intravenous delivery systems and on the stability of the drug.

PubMed

De Vroe, C; De Muynck, C; Remon, J P; Scheldewaert, R; Colardyn, F

1989-04-01

The stability and the sorption by intravenous delivery systems of the calcium antagonist diltiazem dissolved into either 5% dextrose or 0.9% sodium chloride solutions have been investigated, under conditions simulating current clinical practice. Static experiments showed an excellent stability and no sorption after 48 h. Dynamic experiments, at a perfusion rate of 20 mg h-1, showed no sorption of the drug by infusion fluid containers, burettes or administration sets. For end-line filters a temporary decrease of the recovered amount of diltiazem was observed but only with the 0.9% NaCl solution. It is concluded that the stability and the sorption of diltiazem offers no problem with regard to clinical efficacy.

Effect of implant macro-design on primary stability: A prospective clinical study.

PubMed

Lozano-Carrascal, Naroa; Salomó-Coll, Oscar; Gilabert-Cerdà, Marta; Farré-Pagés, Nuria; Gargallo-Albiol, Jordi; Hernández-Alfaro, Federico

2016-03-01

Implant restorations have become a high predictable treatment option. Several caracteristics such as surgical technique and implant design can influence the treatment outcomes. The aim of the present study was to evaluate the influence of implant macro-design on primary stability measured with resonance frequency analysis (RFA) and insertion torque (IT). Material and Mehods: A total of 47 implants divided in two groups: Test group (TI): 22 Tapered MIS® Seven implants; Control group (CI): 25 cylindrical Astra® Osseospeed implants. All implants were inserted following the manufacturers' standard protocols. Implant primary stability was measured at the moment of implant placement by registering insertion torque values (ITv) and ISQ values by means of Osstell™ Mentor (ISQv) (Integration Diagnostic Ltd., Goteborg, Sweden). In the mandible, mean ISQv for tapered implants (TI) was 71.67±5.16 and for cylindrical implants (CI) 57.15±4.83 (p=0.01). Mean insertion torque was 46.67±6.85 Ncm for TI and 35.77±6.72 Ncm for CI (p=0.01). In the maxilla, mean ISQ was 67.2±4.42 for tapered implants and 49.17±15.30 for cylindrical implants (p=0.01). Mean insertion torque for TI was 41.5±6.26 Ncm and for CI 39.17±6.34 Ncm (p>0.05). For tapered implants, no correlation could be found between implant diameter and primary stability. But for cylindrical implants there was a statistically significant correlation between implant diameter and primary stability: ITv (p=0.03); ISQv (p=0.04). Within the limits of the present study, tapered shaped implants achieve higher primary stability measured through ISQ and insertion torque values. Moreover, for cylindrical implants positive correlation has been established between implant diameter and primary stability.

Antioxidants intake and dry eye syndrome: a crossover, placebo-controlled, randomized trial.

PubMed

Drouault-Holowacz, Sophie; Bieuvelet, Séverine; Burckel, André; Rigal, Danièle; Dubray, Claude; Lichon, Jean-Louis; Bringer, Paul; Pilon, Francois; Chiambaretta, Frédéric

2009-01-01

To assess whether an orally administered antioxidant dietary supplement could improve the objective clinical signs and alleviate the subjective symptoms of dry eye syndrome. Twenty-four subjects diagnosed with dry eye syndrome were randomized in a crossover, double-blind, controlled, randomized study to receive a placebo or an antioxidants combination (Oxybiane) for 12 weeks. In all subjects, break-up time (BUT) test, Schirmer test, ocular symptoms (sore eyes, burning, itching, sensation of foreign object in the eye, photophobia, sticky eyes, and redness), visual comfort, and general well-being were evaluated weekly. After 12 weeks of supplementation with Oxybiane, both the BUT scores (27.3%+/-8.4% with Oxybiane versus 3.61%+/-4.3% with the placebo, p=0.017) and the Schirmer scores (26.9%+/-14.2% with Oxybiane versus -4.7%+/-3.4% with the placebo, p=0.037) were significantly increased. A significantly improvement was also observed considering subjective clinical symptoms such as burning (p=0.031), itching (p=0.027), sensation of foreign body in eye (p=0.030), and redness (p=0.043). CONCLUSIONS. Supplementation with oral antioxidants can improve both tear stability and quantity but also subjective clinical signs.

Transoral Decompression and Anterior Stabilization of Atlantoaxial Joint in Patients with Basilar Impression and Chiari Malformation Type I: A Technical Report of 2 Clinical Cases.

PubMed

Shkarubo, Alexey N; Kuleshov, Alexander A; Chernov, Ilia V; Vetrile, Marchel S

2017-06-01

Presentation of clinical cases involving successful anterior stabilization of the C1-C2 segment in patients with invaginated C2 odontoid process and Chiari malformation type I. Clinical case description. Two patients with C2 odontoid processes invagination and Chiari malformation type I were surgically treated using the transoral approach. In both cases, anterior decompression of the upper cervical region was performed, followed by anterior stabilization of the C1-C2 segment. In 1 of the cases, this procedure was performed after posterior decompression, which led to transient regression of neurologic symptoms. In both cases, custom-made cervical plates were used for anterior stabilization of the C1-C2 segment. During the follow-up period of more than 2 years, a persistent regression of both the neurologic symptoms and Chiari malformation was observed. Anterior decompression followed by anterior stabilization of the C1-C2 segment is a novel and promising approach to treating Chiari malformation type I in association with C2 odontoid process invagination. Copyright © 2017 Elsevier Inc. All rights reserved.

Evaluation of the Viabilities and Stabilities of Pathogenic Mold and Yeast Species Using Three Different Preservation Methods Over a 12-Year Period Along with a Review of Published Reports.

PubMed

Karabıçak, Nilgün; Karatuna, Onur; Akyar, Işın

2016-06-01

Serious mycological work requires a reliable source of cultures that are maintained under safe long-term storage. In this study, 1186 clinical fungal isolates consisting of molds (20 species in 11 genera) and yeasts (21 species in seven genera) maintained in water, under mineral oil at room temperature and cryopreserved at -80 °C for periods ranging from 1 to 12 years, were evaluated for their viabilities and stabilities. The strains were subcultured onto either Sabouraud dextrose agar or potato dextrose agar to determine the viabilities and purities. The stabilities of the dermatophytes were investigated using urease test medium, the Trichophyton agar test and morphological examination. The stabilities of yeasts were evaluated by microscopic morphology and by determining the antifungal susceptibilities of random samples of yeasts (n = 120). Additionally, 365 strains (dermatophytes, n = 115; yeasts, n = 250) were further characterized by "matrix-assisted laser desorption/ionization time-of-flight mass spectrometry." After 12 years of preservation, the survival rates with the three different preservation techniques, i.e., in water, under mineral oil and by freezing, were assessed as 94.7, 82.0 and 97.4 %, respectively. Viability was generally unrelated to the duration of storage. More stable and consistent growth was achieved after storage in water and freezing compared with mineral oil preservation. Our results demonstrate that the procedure for maintaining fungal cultures in water is a simple and inexpensive method, next to cryopreservation, and that both can be reliably used for the long-term preservation of most fungal isolates.

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

Stability of ionized calcium measurements at concentrations less than 0.3 mmol/L by point-of-care blood gas instruments: application for postfilter calcium quality control in patients with citrate anticoagulation during extracorporeal circulation.

PubMed

Averina, Maria; Jakobsen, Raymond

2017-05-01

Background Measurements of ionized calcium (Ca 2+ ) at concentrations less than 0.3 mmol/L are required for postfilter control in patients who receive extracorporeal circulation with sodium citrate anticoagulation. This study evaluates the stability of the Ca 2+ measurements at such concentrations. Methods The stability of the Ca 2+ measurements was tested by measuring daily the external standard Qualicheck concentration 3 s7950, Radiometer (0.22-0.25 mmol/L) by blood gas instruments ABL800 and ABL90, Radiometer. Two different Ca 2+ membrane lots were tested for the usual membrane lifetime of 12 weeks at ABL800 instruments. For the ABL90 instrument, the sensor cassette (with Ca 2+ membrane and electrode) was replaced after four weeks as required. Results We observed over 40% Ca 2+ increase within the usual 12 weeks lifetime of the Ca 2+ membrane at the ABL800 instruments. Measurements of Ca 2+ at concentrations less than 0.3 mmol/L were within acceptable limits for both ABL800 and ABL90 instruments when Ca 2+ membrane and sensor cassette were replaced after four weeks. Conclusions For ABL800 instruments, it is necessary to use an extra quality control (<0.3 mmol/L) in addition to the usual quality controls to monitor Ca 2+ measurements below 0.3 mmol/L. The acceptable stability of the Ca 2+ measurements can be achieved by the Ca 2+ membrane and sensor cassette replacement after four weeks. If the usual 12 weeks of Ca 2+ membrane lifetime is maintained, it may result in a clinically significant overestimation of Ca 2+ by ABL800 instruments.

Effects of weight management program on postural stability and neuromuscular function among obese children: study protocol for a randomized controlled trial.

PubMed

Sun, Fenghua; Wang, Li-Juan; Wang, Lin

2015-04-10

Childhood obesity is one of the most critical public health problems in the world. It is associated with low neuromuscular function and postural deformities. Whether weight loss can improve postural stability and neuromuscular control, benefit daily activities, or prevent injury is unknown. Therefore, this study attempts to investigate the effect of a 6 month weight management program on postural stability and neuromuscular control among obese children. We will conduct a prospective, single-blind, randomized controlled trial with 120 prepubescent obese children. Participants will be randomly assigned to a weight management group or a control group. The weight management group will participate in a dietary and exercise program. The control group will receive health education. After the intervention, participants will be followed for 6 months with no active intervention. The primary and secondary outcomes will be assessed at the baseline, and after 6 months and 12 months. Primary outcome measures will include body weight, body height, body mass index, waist circumference, hip circumference, and body fat percentage. Secondary outcome measures will include three-dimensional functional biomechanics in different tasks, proprioception tests of the knee and ankle, neuromuscular response of the leg muscles, and muscle strength tests of the knee and ankle. Furthermore, adverse events will be recorded and analyzed. An intention-to-treat analysis will be performed if any participants withdraw from the trial. The important features of this trial include the randomization procedures and large sample size. This study attempts to estimate the effect of weight loss intervention on outcomes, including daily life function, postural stability, and neuromuscular control in prepubescent obese children. Therefore, our results can be useful for obese children, medical staff, and healthcare decision makers. Chinese Clinical Trial Registry ChiCTR-IOB-15005874.

Imposed Work of Breathing for Flow Meters with In-Line versus Flow-Through Technique during Simulated Neonatal Breathing.

PubMed

Donaldsson, Snorri; Falk, Markus; Jonsson, Baldvin; Drevhammar, Thomas

2015-01-01

The ability to determine airflow during nasal CPAP (NCPAP) treatment without adding dead space or resistance would be useful when investigating the physiologic effects of different NCPAP systems on breathing. The aim of this study was to investigate the effect on pressure stability of different flow measuring devices at the in-line and flow-through position, using simulated neonatal breathing. Six different flow measure devices were evaluated by recording pressure changes and imposed work of breathing for breaths with 16 and 32 ml tidal volumes. The tests were performed initially with the devices in an in line position and with 5 and 10 L/min using flow through technique, without CPAP. The flow meters were then subsequently tested with an Infant Flow CPAP system at 3, 5 and 8 cm H2O pressure using flow through technique. The quality of the recorded signals was compared graphically. The resistance of the measuring devices generated pressure swings and imposed work of breathing. With bias flow, the resistance also generated CPAP pressure. Three of the devices had low resistance and generated no changes in pressure stability or CPAP pressure. The two devices intended for neonatal use had the highest measured resistance. The importance of pressure stability and increased work of breathing during non-invasive respiratory support are insufficiently studied. Clinical trials using flow-through technique have not focused on pressure stability. Our results indicate that a flow-through technique might be a way forward in obtaining a sufficiently high signal quality without the added effects of rebreathing and increased work of breathing. The results should stimulate further research and the development of equipment for dynamic flow measurements in neonates.

Imposed Work of Breathing for Flow Meters with In-Line versus Flow-Through Technique during Simulated Neonatal Breathing

PubMed Central

2015-01-01

Background The ability to determine airflow during nasal CPAP (NCPAP) treatment without adding dead space or resistance would be useful when investigating the physiologic effects of different NCPAP systems on breathing. The aim of this study was to investigate the effect on pressure stability of different flow measuring devices at the in-line and flow-through position, using simulated neonatal breathing. Methods Six different flow measure devices were evaluated by recording pressure changes and imposed work of breathing for breaths with 16 and 32 ml tidal volumes. The tests were performed initially with the devices in an in line position and with 5 and 10 L/min using flow through technique, without CPAP. The flow meters were then subsequently tested with an Infant Flow CPAP system at 3, 5 and 8 cm H2O pressure using flow through technique. The quality of the recorded signals was compared graphically. Results The resistance of the measuring devices generated pressure swings and imposed work of breathing. With bias flow, the resistance also generated CPAP pressure. Three of the devices had low resistance and generated no changes in pressure stability or CPAP pressure. The two devices intended for neonatal use had the highest measured resistance. Conclusion The importance of pressure stability and increased work of breathing during non-invasive respiratory support are insufficiently studied. Clinical trials using flow-through technique have not focused on pressure stability. Our results indicate that a flow-through technique might be a way forward in obtaining a sufficiently high signal quality without the added effects of rebreathing and increased work of breathing. The results should stimulate further research and the development of equipment for dynamic flow measurements in neonates. PMID:26192188

Color stability and marginal integrity of interim crowns: An in vitro study

PubMed Central

Elagra, Marwa I.; Rayyan, Mohammad R.; Alhomaidhi, Maisam M.; Alanaziy, Areej A.; Alnefaie, Mona O.

2017-01-01

Objective: Many commercial dental materials are used to fabricate interim restorations. This study aimed to compare the color stability and the marginal integrity of four different interim crown materials. Materials and Methods: An ivorine right maxillary central incisor was prepared for a full coverage all-ceramic restoration. A total of 36 specimens in the form of crowns were fabricated on the master die using four different materials (n = 9); Polymethyl methacrylate (PMMA) resin (TrimPLUS), PMMA computer-aided design, and computer-aided manufacturing (CAD-CAM) blocks (Ceramill TEMP), cold cure bis-acryl resin (Success CD), and bis-acryl resin dual-cure composite (TempSpan). Color change ΔE for each sample was calculated by measuring its color as Commission Internationale de l’Eclairage L* a* b* with a spectrophotometer before and after immersing in a concentrated tea solution for 7 days. Marginal gap was measured at four reference points using stereomicroscope at ×40. One-way ANOVA and the Tukey multiple comparisons test were used to determine any statistically significant difference between the four groups, (α = 0.05). Results: Success CD showed significantly the greatest color change (7.7) among all the tested materials, while no significant difference was found between the other three materials. TempSpan showed significantly the highest marginal gap formation (430.15 μm), while no significant difference was found between the three other materials. Conclusions: Bis-acryl resin composite materials demonstrated clinically noticeable change in color while PMMA materials demonstrated superior color stability. Dual cure interim materials exhibited significantly higher marginal discrepancy in comparison to PMMA and cold cure bis-acrylic resin materials. CAD-CAM PMMA material exhibited the best color stability and marginal integrity. PMID:28932142

The influence of uncemented femoral stem length and design on its primary stability: a finite element analysis.

PubMed

Reimeringer, M; Nuño, N; Desmarais-Trépanier, C; Lavigne, M; Vendittoli, P A

2013-01-01

One of the crucial factors for short- and long-term clinical success of total hip arthroplasty cementless implants is primary stability. Indeed, motion at the bone-implant interface above 40 μm leads to partial bone ingrowth, while motion exceeding 150 μm completely inhibits bone ingrowth. The aim of this study was to investigate the effect of two cementless femoral stem designs with different lengths on the primary stability. A finite element model of a composite Sawbones(®) fourth generation, implanted with five lengths of the straight prosthesis design and four lengths of the curved prosthesis design, was loaded with hip joint and abductor forces representing two physiological activities: fast walking and stair climbing. We found that reducing the straight stem length from 146 to 54 mm increased the average micromotion from 17 to 52 μm during fast walking, while the peak value increased from 42 to 104 μm. With the curved stem, reducing length from 105 to 54 mm increased the average micromotion from 10 to 29 μm, while the peak value increased from 37 to 101 μm. Similar findings are obtained for stair climbing for both stems. Although the present study showed that femoral stem length as well as stem design directly influences its primary stability, for the two femoral stems tested, length could be reduced substantially without compromising the primary stability. With the aim of minimising surgical invasiveness, newer femoral stem design and currently well performing stems might be used with a reduced length without compromising primary stability and hence, long-term survivorship.

Cardiorespiratory fitness and age-related arterial stiffness in women with systemic lupus erythematosus.

PubMed

Montalbán-Méndez, Cristina; Soriano-Maldonado, Alberto; Vargas-Hitos, José A; Sáez-Urán, Luis M; Rosales-Castillo, Antonio; Morillas-de-Laguno, Pablo; Gavilán-Carrera, Blanca; Jiménez-Alonso, Juan

2018-03-01

The aim of this study was twofold: (i) to examine the association of cardiorespiratory fitness with arterial stiffness in women with systemic lupus erythematosus; (ii) to assess the potential interaction of cardiorespiratory fitness with age on arterial stiffness in this population. A total of 49 women with systemic lupus erythematosus (mean age 41.3 [standard deviation 13.8] years) and clinical stability during the previous 6 months were included in the study. Arterial stiffness was assessed through pulse wave velocity (Mobil-O-Graph® 24 hours pulse wave velocity monitor). Cardiorespiratory fitness was estimated with the Siconolfi step test and the 6-minute walk test. Cardiorespiratory fitness was inversely associated with pulse wave velocity in crude analyses (P < .05), although this relationship was attenuated when age and other cardiovascular risk factors were controlled. There was a cardiorespiratory fitness × age interaction effect on pulse wave velocity, regardless of the test used to estimate cardiorespiratory fitness (P < .001 for the Siconolfi step test; P = .005 for the 6-minute walk test), indicating that higher cardiorespiratory fitness was associated with a lower increase in pulse wave velocity per each year increase in age. The results of this study suggest that cardiorespiratory fitness might attenuate the age-related arterial stiffening in women with systemic lupus erythematosus and might thus contribute to the primary prevention of cardiovascular disease in this population. As the cross-sectional design precludes establishing causal relationships, future clinical trials should confirm or contrast these findings. © 2018 Stichting European Society for Clinical Investigation Journal Foundation.

Stability and maturity of biowaste composts derived by small municipalities: Correlation among physical, chemical and biological indices.

PubMed

Oviedo-Ocaña, E R; Torres-Lozada, P; Marmolejo-Rebellon, L F; Hoyos, L V; Gonzales, S; Barrena, R; Komilis, D; Sanchez, A

2015-10-01

Stability and maturity are important criteria to guarantee the quality of a compost that is applied to agriculture or used as amendment in degraded soils. Although different techniques exist to evaluate stability and maturity, the application of laboratory tests in municipalities in developing countries can be limited due to cost and application complexities. In the composting facilities of such places, some classical low cost on-site tests to monitor the composting process are usually implemented; however, such tests do not necessarily clearly identify conditions of stability and maturity. In this article, we have applied and compared results of stability and maturity tests that can be easily employed on site (i.e. temperature, pH, moisture, electrical conductivity [EC], odor and color), and of tests that require more complex laboratory techniques (volatile solids, C/N ratio, self-heating, respirometric index, germination index [GI]). The evaluation of the above was performed in the field scale using 2 piles of biowaste applied compost. The monitoring period was from day 70 to day 190 of the process. Results showed that the low-cost tests traditionally employed to monitor the composting process on-site, such as temperature, color and moisture, do not provide consistent determinations with the more complex laboratory tests used to assess stability (e.g. respiration index, self-heating, volatile solids). In the case of maturity tests (GI, pH, EC), both the on-site tests (pH, EC) and the laboratory test (GI) provided consistent results. Although, stability was indicated for most of the samples, the maturity tests indicated that products were consistently immature. Thus, a stable product is not necessarily mature. Conclusively, the decision on the quality of the compost in the installations located in developing countries requires the simultaneous use of a combination of tests that are performed both in the laboratory and on-site. Copyright © 2015 Elsevier Ltd. All rights reserved.

Normative Data for the NeuroCom Sensory Organization Test in US Military Special Operations Forces

PubMed Central

Pletcher, Erin R.; Williams, Valerie J.; Abt, John P.; Morgan, Paul M.; Parr, Jeffrey J.; Wohleber, Meleesa F.; Lovalekar, Mita; Sell, Timothy C.

2017-01-01

Context: Postural stability is the ability to control the center of mass in relation to a person's base of support and can be affected by both musculoskeletal injury and traumatic brain injury. The NeuroCom Sensory Organization Test (SOT) can be used to objectively quantify impairments to postural stability. The ability of postural stability to predict injury and be used as an acute injury-evaluation tool makes it essential to the screening and rehabilitation process. To our knowledge, no published normative data for the SOT from a healthy, highly active population are available for use as a reference for clinical decision making. Objective: To present a normative database of SOT scores from a US Military Special Operations population that can be used for future comparison. Design: Cross-sectional study. Setting: Human performance research laboratory. Patients or Other Participants: A total of 542 active military operators from Naval Special Warfare Combatant-Craft Crewmen (n = 149), Naval Special Warfare Command, Sea, Air, and Land (n = 101), US Army Special Operations Command (n = 171), and Air Force Special Operations Command (n = 121). Main Outcome Measure(s): Participants performed each of the 6 SOT conditions 3 times. Scores for each condition, total equilibrium composite score, and ratio scores for the somatosensory, visual, and vestibular systems were recorded. Results: Differences were present across all groups for SOT conditions 1 (P < .001), 2 (P = .001), 4 (P > .001), 5 (P > .001), and 6 (P = .001) and total equilibrium composite (P = .000), visual (P > .001), vestibular (P = .002), and preference (P > .001) NeuroCom scores. Conclusions: Statistical differences were evident in the distribution of postural stability across US Special Operations Forces personnel. This normative database for postural stability, as assessed by the NeuroCom SOT, can provide context when clinicians assess a Special Operations Forces population or any other groups that maintain a high level of conditioning and training. PMID:28140624

Stability of tranexamic acid in 0.9% sodium chloride, stored in type 1 glass vials and ethylene/propylene copolymer plastic containers.

PubMed

McCluskey, Susan V; Sztajnkrycer, Matthew D; Jenkins, Donald A; Zietlow, Scott P; Berns, Kathleen S; Park, Myung S

2014-01-01

Tranexamic acid has recently been demonstrated to decrease all-cause mortality and deaths due to hemorrhage in trauma patients. The optimal administration of tranexamic acid is within one hour of injury, but not more than three hours from the time of injury. To aid with timely administration, a premixed solution of 1 gram tranexamic acid and 0.9% sodium chloride was proposed to be stocked as a medication in both the aeromedical transport helicopters and Emergency Department at Mayo Clinic Hospital--Rochester Saint Marys Campus. Since no published stability data exists for tranexamic acid diluted with 0.9% sodium chloride, this study was undertaken to determine the stability of tranexamic acid diluted with 0.9% sodium chloride while being stored in two types of containers. Stability was determined through the use of a stability-indicating high-performance liquid reverse phase chromatography assay, pH, and visual tests. Tranexamic acid solutions of 1 gram in 0.9% sodium chloride 65 mL were studied at predetermined intervals for 90 days in ethylene/propylene copolymer plastic containers, protected from light, and at both controlled room and refrigerated temperatures. Tranexamic acid solutions of 1 gram in 0.9% sodium chloride 50 mL were studied at predetermined intervals for 180 days in clear Type 1 borosilicate glass vials sealed with intact elastomeric, Flourotec-coated stoppers, stored protected from light at controlled room temperature. Solutions stored in the ethylene/propylene copolymer plastic containers at both storage temperatures maintained at least 98% of initial potency throughout the 90-day study period. Solutions stored in glass vials at controlled room temperature maintained at least 92% of initial potency throughout the 180-day study period. Visual and pH tests revealed stable, clear, colorless, and particulate-free solutions throughout the respective study periods.

Comparative biomechanical investigation of a modular dynamic lumbar stabilization system and the Dynesys system

PubMed Central

Gédet, Philippe; Haschtmann, Daniel; Thistlethwaite, Paul A.

2009-01-01

The goal of non-fusion stabilization is to reduce the mobility of the spine segment to less than that of the intact spine specimen, while retaining some residual motion. Several in vitro studies have been conducted on a dynamic system currently available for clinical use (Dynesys®). Under pure moment loading, a dependency of the biomechanical performance on spacer length has been demonstrated; this variability in implant properties is removed with a modular concept incorporating a discrete flexible element. An in vitro study was performed to compare the kinematic and stabilizing properties of a modular dynamic lumbar stabilization system with those of Dynesys, under the influence of an axial preload. Six human cadaver spine specimens (L1–S1) were tested in a spine loading apparatus. Flexibility measurements were performed by applying pure bending moments of 8 Nm, about each of the three principal anatomical axes, with a simultaneously applied axial preload of 400 N. Specimens were tested intact, and following creation of a defect at L3–L4, with the Dynesys implant, with the modular implant and, after removal of the hardware, the injury state. Segmental range of motion (ROM) was reduced for flexion–extension and lateral bending with both implants. Motion in flexion was reduced to less than 20% of the intact level, in extension to approximately 40% and in lateral bending a motion reduction to less than 40% was measured. In torsion, the total ROM was not significantly different from that of the intact level. The expectations for a flexible posterior stabilizing implant are not fulfilled. The assumption that a device which is particularly compliant in bending allows substantial intersegmental motion cannot be fully supported when one considers that such devices are placed at a location far removed from the natural rotation center of the intervertebral joint. PMID:19565278

Stability of Hydromorphone-Ketamine Solutions in Glass Bottles, Plastic Syringes, and IV Bags for Pediatric Use.

PubMed

Ensom, Mary H H; Decarie, Diane; Leung, Karen; Montgomery, Carolyne

2009-03-01

To evaluate the stability of mixtures of hydromorphone and ketamine in 0.9% sodium chloride (normal saline [NS]) after storage for up to 7 days at room temperature (25°C). The stability of 3 standard mixtures of hydromorphone and ketamine (hydromorphone 0.2 mg/mL + ketamine 0.2 mg/mL, hydromorphone 0.2 mg/mL + ketamine 0.6 mg/mL, and hydromorphone 0.2 mg/mL + ketamine 1.0 mg/mL) in NS was studied. Portions of each mixture were transferred to 3 brown glass bottles (100 mL), 3 plastic syringes (50 mL), and 3 IV bags (50 mL), which were then stored at room temperature (25°C). Physical characteristics, including pH, colour, and precipitation, were evaluated daily. Three 1.5-mL samples were collected from each bottle, syringe, and IV bag at baseline, at 24, 48, and 72 hours, and on day 7. Samples were analyzed in triplicate by a stability-indicating high-performance liquid chromatography method. Solutions were considered stable if they maintained 90% of the initial concentration of each drug. Samples from syringes and IV bags were subjected to standard sterility testing by incubation for 5 days in an enriched culture media. No notable changes in pH or colour were observed, and no precipitation occurred in any of the solutions. All formulations maintained more than 90% of the initial concentration of each drug on day 7. No bacterial growth was observed in any of the samples tested. Mixtures of hydromorphone and ketamine were stable for up 7 days at 25°C, and the sterility of the preparations was maintained. Because stability alone does not guarantee efficacy, it is recommended that clinical studies be conducted to evaluate the pharmacokinetics and pharmacodynamics of these formulations.

Normative Data for the NeuroCom Sensory Organization Test in US Military Special Operations Forces.

PubMed

Pletcher, Erin R; Williams, Valerie J; Abt, John P; Morgan, Paul M; Parr, Jeffrey J; Wohleber, Meleesa F; Lovalekar, Mita; Sell, Timothy C

2017-02-01

Postural stability is the ability to control the center of mass in relation to a person's base of support and can be affected by both musculoskeletal injury and traumatic brain injury. The NeuroCom Sensory Organization Test (SOT) can be used to objectively quantify impairments to postural stability. The ability of postural stability to predict injury and be used as an acute injury-evaluation tool makes it essential to the screening and rehabilitation process. To our knowledge, no published normative data for the SOT from a healthy, highly active population are available for use as a reference for clinical decision making. To present a normative database of SOT scores from a US Military Special Operations population that can be used for future comparison. Cross-sectional study. Human performance research laboratory. A total of 542 active military operators from Naval Special Warfare Combatant-Craft Crewmen (n = 149), Naval Special Warfare Command, Sea, Air, and Land (n = 101), US Army Special Operations Command (n = 171), and Air Force Special Operations Command (n = 121). Participants performed each of the 6 SOT conditions 3 times. Scores for each condition, total equilibrium composite score, and ratio scores for the somatosensory, visual, and vestibular systems were recorded. Differences were present across all groups for SOT conditions 1 (P < .001), 2 (P = .001), 4 (P > .001), 5 (P > .001), and 6 (P = .001) and total equilibrium composite (P = .000), visual (P > .001), vestibular (P = .002), and preference (P > .001) NeuroCom scores. Statistical differences were evident in the distribution of postural stability across US Special Operations Forces personnel. This normative database for postural stability, as assessed by the NeuroCom SOT, can provide context when clinicians assess a Special Operations Forces population or any other groups that maintain a high level of conditioning and training.

Primary stability in reversed-anatomy glenoid components.

PubMed

Hopkins, A R; Hansen, U N

2009-10-01

Reversed-anatomy shoulder replacement is advocated for patients with poor rotator cuff condition, for whom an anatomical reconstruction would provide little or no stability. Modern generations of this concept appear to be performing well in the short-term to midterm clinical follow-up. These designs are almost always non-cemented, requiring a high degree of primary stability to encourage bone on-growth and so to establish long-term fixation. Six different inverse-anatomy glenoid implants, currently on the market and encompassing a broad range of geometrical differences, were compared on the basis of their ability to impart primary stability through the minimization of interface micromotions. Fixing screws were only included in the supero-inferior direction in appropriate implants and were always inclined at the steepest available angle possible during surgery (up to a maximum of 30 degrees). The extent of predicted bony on-growth was, of course, highly dependent on the threshold for interface micromotion. In some instances an additional 30 per cent of the interface was predicted to promote bone on-growth when the threshold was raised from 20 microm to 50 microm. With maximum thresholds of micromotion for bone on-growth set to 30 microm, the Zimmer Anatomical device was found to be the most stable of the series of the six designs tested herein, achieving an additional 3 per cent (by surface area) of bone on-growth above the closest peer product (Biomet Verso). When this threshold was raised to 50 microm, the Biomet Verso design was most stable (3 per cent above the second-most stable design, the Zimmer Anatomical). Peak micromotions were not a good indicator of the predicted area of bone on-growth and could lead to some misinterpretation of the implant's overall performance. All but one of the implants tested herein provided primary stability sufficient to resist motions in excess of 150 microm at the interface.

Cognitive vulnerability to depression during middle childhood: Stability and associations with maternal affective styles and parental depression

PubMed Central

Hayden, Elizabeth P.; Olino, Thomas M.; Mackrell, Sarah V.M.; Jordan, Patricia L.; Desjardins, Jasmine; Katsiroumbas, Patrice

2014-01-01

Theories of cognitive vulnerability to depression (CVD) imply that CVD is early-emerging and trait-like; however, little longitudinal work has tested this premise in middle childhood, or examined theoretically relevant predictors of child CVD. We examined test–retest correlations of self-referent encoding task performance and self-reported attributional styles and their associations with parental characteristics in 205 seven-year-olds. At baseline, child CVD was assessed, structured clinical interviews were conducted with parents, and ratings of observed maternal affective styles were made. Children’s CVD was re-assessed approximately one and two years later. Both measures of children’s CVD were prospectively and concurrently associated with children’s depressive symptoms and showed modest stability. Multilevel modeling indicated that maternal criticism and paternal depression were related to children’s CVD. Findings indicate that even early-emerging CVD is a valid marker of children’s depression risk. PMID:25392596

Effect of extreme data loss on heart rate signals quantified by entropy analysis

NASA Astrophysics Data System (ADS)

Li, Yu; Wang, Jun; Li, Jin; Liu, Dazhao

2015-02-01

The phenomenon of data loss always occurs in the analysis of large databases. Maintaining the stability of analysis results in the event of data loss is very important. In this paper, we used a segmentation approach to generate a synthetic signal that is randomly wiped from data according to the Gaussian distribution and the exponential distribution of the original signal. Then, the logistic map is used as verification. Finally, two methods of measuring entropy-base-scale entropy and approximate entropy-are comparatively analyzed. Our results show the following: (1) Two key parameters-the percentage and the average length of removed data segments-can change the sequence complexity according to logistic map testing. (2) The calculation results have preferable stability for base-scale entropy analysis, which is not sensitive to data loss. (3) The loss percentage of HRV signals should be controlled below the range (p = 30 %), which can provide useful information in clinical applications.

Aristoforin, a novel stable derivative of hyperforin, is a potent anticancer agent.

PubMed

Gartner, Michael; Müller, Thomas; Simon, Jan C; Giannis, Athanassios; Sleeman, Jonathan P

2005-01-01

Hyperforin, a natural product of St. John's wort (Hypericum perforatum L.), has a number of pharmacological activities, including antidepressive and antibacterial properties. Furthermore, hyperforin has pronounced antitumor properties against different tumor cell lines, both in vitro and in vivo. Despite being a promising novel anticancer agent, the poor solubility and stability of hyperforin in aqueous solution limits its potential clinical application. In this study, we present the synthesis of hyperforin derivatives with improved pharmacological activity. The synthesized compounds were tested for their solubility and stability properties. They were also investigated for their antitumor properties, both in vitro and in vivo. One of these hyperforin derivatives, Aristoforin, is more soluble in aqueous solution than hyperforin and is additionally highly stable. Importantly, it retains the antitumor properties of the parental compound without inducing toxicity in experimental animals. These data strongly suggest that Aristoforin has potential as an anticancer drug.

iBEST: intelligent Balance assessment and Stability Training system using smartphone.

PubMed

Wai, Aung Aung Phyo; Duc, Pham Duy; Syin, Chan; Zhang, Haihong

2014-01-01

Patients with postural instability could lead to falls and injuries while walking due to balance disorders. So those patients need regular balance training and evaluation to improve and examine balance deficiencies. But many do not notice such balance issues; resulting lack of timely preventive measures. This shows the needs of affordable and accessible solution for balance training and assessment. So iBEST (intelligent Balance assessment and Stability Training) is proposed enabling to train and assess balance conveniently anywhere anytime. Moreover, therapists can remotely evaluate and manage their recovery progress. These benefits can be realized leveraging sensors from smartphone, cloud-based data analytics and web applications. iBEST employs sensorised automated balance assessment in digitizing Berg Balance Scale (BBS) clinical risk assessment tool. The initial feasibility study showed average accuracy of 90.22% using smartphone in classifying the specified BBS test items.

Application of vibrational spectroscopy, thermal analyses and X-ray diffraction in the rapid evaluation of the stability in solid-state of ranitidine, famotidine and cimetidine.

PubMed

Jamrógiewicz, Marzena; Ciesielski, Aleksander

2015-03-25

This paper reports the study on applicability of Fourier transform infrared (FTIR), near-infrared (NIR) and Raman spectroscopy, differential scanning calorimetry (DSC) and X-ray diffraction (XRD) for the estimation of the chemical stability and photostability of histamine H2-receptor antagonist substances. Ranitidine hydrochloride (RAN), famotidine (FAM) and cimetidine (CIM) were tested and differences in sensitivity were measured via soft independence modeling of class analogies (Simca) model. The low values of variations for FAM and CIM and high variations obtained for RAN using FTIR and NIR techniques indicated that these methods were suitable and applicable to classify the degradation of RAN. Examined methods are recommendable in the first technological stage of drug production, and the preclinical and clinical development of pharmaceuticals or their quality control. Copyright © 2015 Elsevier B.V. All rights reserved.

40 CFR 799.5085 - Chemical testing requirements for certain high production volume chemicals.

Code of Federal Regulations, 2011 CFR

2011-07-01

... diluted in water or tested as a stabilized mixture with an appropriate stabilizer (e.g., D-lactose monohydrate is the stabilizer in PETN, NF which is a mixture of 20% by weight PETN and 80% by weight D-lactose...

21 CFR 212.61 - What must I do to ensure the stability of my PET drug products through expiry?

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false What must I do to ensure the stability of my PET... my PET drug products through expiry? (a) Stability testing program. You must establish, follow, and maintain a written testing program to assess the stability characteristics of your PET drug products. The...

21 CFR 212.61 - What must I do to ensure the stability of my PET drug products through expiry?

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false What must I do to ensure the stability of my PET... my PET drug products through expiry? (a) Stability testing program. You must establish, follow, and maintain a written testing program to assess the stability characteristics of your PET drug products. The...

21 CFR 212.61 - What must I do to ensure the stability of my PET drug products through expiry?

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false What must I do to ensure the stability of my PET... my PET drug products through expiry? (a) Stability testing program. You must establish, follow, and maintain a written testing program to assess the stability characteristics of your PET drug products. The...

21 CFR 212.61 - What must I do to ensure the stability of my PET drug products through expiry?

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false What must I do to ensure the stability of my PET... my PET drug products through expiry? (a) Stability testing program. You must establish, follow, and maintain a written testing program to assess the stability characteristics of your PET drug products. The...

[Definition and stabilization of processes I. Management processes and support in a Urology Department].

PubMed

Pascual, Carlos; Luján, Marcos; Mora, José Ramón; Chiva, Vicente; Gamarra, Manuela

2015-01-01

The implantation of total quality management models in clinical departments can better adapt to the 2009 ISO 9004 model. An essential part of implantation of these models is the establishment of processes and their stabilization. There are four types of processes: key, management, support and operative (clinical). Management processes have four parts: process stabilization form, process procedures form, medical activities cost estimation form and, process flow chart. In this paper we will detail the creation of an essential process in a surgical department, such as the process of management of the surgery waiting list.

Development of cross-resistance by Aspergillus fumigatus to clinical azoles following exposure to prochloraz, an agricultural azole

PubMed Central

2014-01-01

Background The purpose of this study was to unveil whether azole antifungals used in agriculture, similar to the clinical azoles used in humans, can evoke resistance among relevant human pathogens like Aspergillus fumigatus, an ubiquitous agent in nature. Additionally, cross-resistance with clinical azoles was investigated. Antifungal susceptibility testing of environmental and clinical isolates of A. fumigatus was performed according to the CLSI M38-A2 protocol. In vitro induction assays were conducted involving daily incubation of susceptible A. fumigatus isolates, at 35°C and 180 rpm, in fresh GYEP broth medium supplemented with Prochloraz (PCZ), a potent agricultural antifungal, for a period of 30 days. Minimal inhibitory concentrations (MIC) of PCZ and clinical azoles were monitored every ten days. In order to assess the stability of the developed MIC, the strains were afterwards sub-cultured for an additional 30 days in the absence of antifungal. Along the in vitro induction process, microscopic and macroscopic cultural observations were registered. Results MIC of PCZ increased 256 times after the initial exposure; cross-resistance to all tested clinical azoles was observed. The new MIC value of agricultural and of clinical azoles maintained stable in the absence of the selective PCZ pressure. PCZ exposure was also associated to morphological colony changes: macroscopically the colonies became mostly white, losing the typical pigmentation; microscopic examination revealed the absence of conidiation. Conclusions PCZ exposure induced Aspergillus fumigatus morphological changes and an evident increase of MIC value to PCZ as well as the development of cross-resistance with posaconazole, itraconazole and voriconazole. PMID:24920078

A proposal to standardize reporting units for fecal immunochemical tests for hemoglobin.

PubMed

Fraser, Callum G; Allison, James E; Halloran, Stephen P; Young, Graeme P

2012-06-06

Fecal immunochemical tests for hemoglobin are replacing traditional guaiac fecal occult blood tests in population screening programs for many reasons. However, the many available fecal immunochemical test devices use a range of sampling methods, differ with regard to hemoglobin stability, and report hemoglobin concentrations in different ways. The methods for sampling, the mass of feces collected, and the volume and characteristics of the buffer used in the sampling device also vary among fecal immunochemical tests, making comparisons of test performance characteristics difficult. Fecal immunochemical test results may be expressed as the hemoglobin concentration in the sampling device buffer and, sometimes, albeit rarely, as the hemoglobin concentration per mass of feces. The current lack of consistency in units for reporting hemoglobin concentration is particularly problematic because apparently similar hemoglobin concentrations obtained with different devices can lead to very different clinical interpretations. Consistent adoption of an internationally accepted method for reporting results would facilitate comparisons of outcomes from these tests. We propose a simple strategy for reporting fecal hemoglobin concentration that will facilitate the comparison of results between fecal immunochemical test devices and across clinical studies. Such reporting is readily achieved by defining the mass of feces sampled and the volume of sample buffer (with confidence intervals) and expressing results as micrograms of hemoglobin per gram of feces. We propose that manufacturers of fecal immunochemical tests provide this information and that the authors of research articles, guidelines, and policy articles, as well as pathology services and regulatory bodies, adopt this metric when reporting fecal immunochemical test results.

Pre-clinical validation of a new intra-operative "dual beam Doppler" blood flowmeter in an artificial circuit.

PubMed

Cikirikcioglu, Mustafa; Cikirikcioglu, Y Banu; Khabiri, Ebrahim; Djebaili, M Karim; Kalangos, Afksendiyos; Walpoth, Beat H

2006-01-01

Intra-operative flow measurement during coronary or peripheral bypass operations is helpful for ruling out technical failures and for prediction of complication and patency rates. Preclinical validation of the flowmeters is required in order to rely on the intra-operatively measured results. The aim of this study is to evaluate a new "dual beam Doppler" blood flowmeter before clinical application and to compare it with the established "transit time flow measure-ment" technique in an artificial circuit. Measurements were performed in an experimental flow model using pig blood and pig arteries. Three different flowmeters were used: Quantix OR (dual beam doppler flowmeter), CardioMed (transit time flowmeter), and Transonic (transit time flowmeter). Three validation tests were performed to assess correlation, precision, and repeatability of devices. (1) Correlation and agreement analysis was performed with various flow amounts (10-350 mL/min) (n = 160). (2) Device reproducibility and measurement stability were tested with a constant flow (flow amount = 300 mL/min) (n = 30). (3) A user accuracy test (intra- and inter-observer variability) was performed by 5 different observers with a constant flow (flow amount = 205 mL/min) (n = 75). Time collected true flow was used as a reference method in all steps and all tests were performed in a blind manner. Results are shown as mean values +/- standard deviations. Pear-son's correlation and Bland-Altman plot analyses were used to compare measurements. The mean flow was 167 +/- 98 mL/min for true flow and 162 +/- 94 mL/min, 165 +/- 94 mL/min, and 166 +/- 100 mL/min for Quantix OR, CardioMed, and Transonic, respectively. Correlation coefficients between Quantix OR, Medi-Stim, Transonic, and time collected true flow were over 0.98 (P = .01). Most of the measured results ( > 90%) were between +/- 1.96 SD agreement limits in Bland and Altman plot analysis. All devices showed good results in the reproducibility test. During the user accuracy test, larger variance changes were observed between intra- and inter-observer results with the dual beam Doppler flowmeter compared to the 2 used transit time flowmeters when used for single sided vessel access without stabilization device (available from the manufacturer). All 3 tested flowmeters showed an excellent correlation to the true flow in an artificial circuit and the accuracy of the tested devices was within agreement limits. Reproducibility of all devices was good and linear. The new dual beam Doppler flow measurement technique compares favorably to the classic transit time method. Clinical use may depend on operator, location, and condition, thus more studies may be required to ensure uniform results using the currently available blood flow measurement devices.

Effects of Liraglutide on Clinical Stability Among Patients With Advanced Heart Failure and Reduced Ejection Fraction: A Randomized Clinical Trial.

PubMed

Margulies, Kenneth B; Hernandez, Adrian F; Redfield, Margaret M; Givertz, Michael M; Oliveira, Guilherme H; Cole, Robert; Mann, Douglas L; Whellan, David J; Kiernan, Michael S; Felker, G Michael; McNulty, Steven E; Anstrom, Kevin J; Shah, Monica R; Braunwald, Eugene; Cappola, Thomas P

2016-08-02

Abnormal cardiac metabolism contributes to the pathophysiology of advanced heart failure with reduced left ventricular ejection fraction (LVEF). Glucagon-like peptide 1 (GLP-1) agonists have shown cardioprotective effects in early clinical studies of patients with advanced heart failure, irrespective of type 2 diabetes status. To test whether therapy with a GLP-1 agonist improves clinical stability following hospitalization for acute heart failure. Phase 2, double-blind, placebo-controlled randomized clinical trial of patients with established heart failure and reduced LVEF who were recently hospitalized. Patients were enrolled between August 2013 and March 2015 at 24 US sites. The GLP-1 agonist liraglutide (n = 154) or placebo (n = 146) via a daily subcutaneous injection; study drug was advanced to a dosage of 1.8 mg/d during the first 30 days as tolerated and continued for 180 days. The primary end point was a global rank score in which all patients, regardless of treatment assignment, were ranked across 3 hierarchical tiers: time to death, time to rehospitalization for heart failure, and time-averaged proportional change in N-terminal pro-B-type natriuretic peptide level from baseline to 180 days. Higher values indicate better health (stability). Exploratory secondary outcomes included primary end point components, cardiac structure and function, 6-minute walk distance, quality of life, and combined events. Among the 300 patients who were randomized (median age, 61 years [interquartile range {IQR}, 52-68 years]; 64 [21%] women; 178 [59%] with type 2 diabetes; median LVEF of 25% [IQR, 19%-33%]; median N-terminal pro-B-type natriuretic peptide level of 2049 pg/mL [IQR, 1054-4235 pg/mL]), 271 completed the study. Compared with placebo, liraglutide had no significant effect on the primary end point (mean rank of 146 for the liraglutide group vs 156 for the placebo group, P = .31). There were no significant between-group differences in the number of deaths (19 [12%] in the liraglutide group vs 16 [11%] in the placebo group; hazard ratio, 1.10 [95% CI, 0.57-2.14]; P = .78) or rehospitalizations for heart failure (63 [41%] vs 50 [34%], respectively; hazard ratio, 1.30 [95% CI, 0.89-1.88]; P = .17) or for the exploratory secondary end points. Prespecified subgroup analyses in patients with diabetes did not reveal any significant between-group differences. The number of investigator-reported hyperglycemic events was 16 (10%) in the liraglutide group vs 27 (18%) in the placebo group and hypoglycemic events were infrequent (2 [1%] vs 4 [3%], respectively). Among patients recently hospitalized with heart failure and reduced LVEF, the use of liraglutide did not lead to greater posthospitalization clinical stability. These findings do not support the use of liraglutide in this clinical situation. clinicaltrials.gov Identifier: NCT01800968.

Ordering pattern and performance of biochemical tests for diagnosing pheochromocytoma between 2000 and 2008.

PubMed

Yu, Run

2009-01-01

To examine what tests are ordered by physicians for pheochromocytoma diagnosis and how those tests perform in modern clinical practice. In this case series, electronic medical records of patients seen between January 2000 and July 2008 at a large academic hospital in Los Angeles, California, were queried, and patients older than 15 years who underwent any 1 of 5 tests for pheochromocytoma (measurement of plasma catecholamines, plasma fractionated metanephrines, urinary catecholamines, urinary metanephrines, or urinary vanillylmandelic acid) were identified. Because testing was performed in various reference laboratories, test results were classified into 1 of 3 categories: (a) markedly elevated, (b) moderately elevated, or (c) normal. Patient demographics, clinical history, test results, imaging study findings, and pathology records were reviewed. A total of 3980 tests were ordered for 1898 patients. Pretest probability was 2.2% (based on 681 patients in whom pheochromocytoma was confirmed or excluded), and hypertension was the most common indication for testing. The number of patients tested and the number of tests ordered increased over the years. The ordering pattern stabilized since 2006 when urinary metanephrines, urinary catecholamines, and plasma metanephrines were ordered more frequently. Sensitivity was highest for urinary metanephrines and vanillylmandelic acid, specificity was highest for vanillylmandelic acid and urinary catecholamines, and positive likelihood ratio was highest for vanillylmandelic acid. Positive predictive value for markedly elevated test results was 39% to 83%, while that for moderately elevated test results was only 2% to 14%. Ordering pattern and test performance differ significantly from those recommended and reported by large centers. The best testing strategy should incorporate local experience. Categorizing test results as markedly elevated, moderately elevated, and normal is important for result interpretation.

SPECT/CT tracer uptake is influenced by tunnel orientation and position of the femoral and tibial ACL graft insertion site.

PubMed

Hirschmann, Michael T; Mathis, Dominic; Rasch, Helmut; Amsler, Felix; Friederich, Niklaus F; Arnold, Markus P

2013-02-01

SPECT/CT is a hybrid imaging modality, which combines a 3D scintigraphy (SPECT) and a conventional computerised tomography (CT). SPECT/CT allows accurate anatomical localisation of metabolic tracer activity. It allows the correlation of surgical factors such as tunnel position and orientation with mechanical alignment, clinical outcome and biological factors. The purpose of this study was to investigate whether the SPECT/CT tracer uptake (intensity and distribution) correlates with the stability and laxity of the knee joint and the position and orientation of the tibial and femoral tunnels in patients after anterior cruciate ligament (ACL) reconstruction. A consecutive series of knees (n=66), with symptoms of pain and/or instability after ACL reconstruction were prospectively evaluated using clinical examination and 99mTc-HDP-SPECT/CT. Clinical laxity testing was performed using the Rolimeter (Ormed, Freiburg, Germany) including Lachman testing (0-2 mm, 3-5 mm, 6-10 mm, >10 mm), anterior drawer test (0-2 mm, 3-5 mm, 6-10 mm, >10 mm), pivot shift test (positive versus negative) and patient-based subjective instability (yes versus no). For analysis of SPECT/CT tracer uptake a previously validated SPECT/CT localisation scheme consisting of 17 tibial, nine femoral and four patellar regions on standardised axial, coronal, and sagittal slices was used. The tracer activity on SPECT/CT was localised and recorded using a 3D volumetric and quantitative analysis software. Mean, standard deviation, minimum and maximum of grading for each area of the localisation scheme were recorded. The position and orientation of the tibial and femoral tunnel was assessed using a previously published method on 3D-CT. Correlation of instability, pivot shift as well as clinical laxity testing with 99mTc-HDP-SPECT/CT tracer uptake intensity and distribution showed no significant correlation. 99mTc-HDP-SPECT/CT tracer uptake correlated significantly with the position and orientation of the ACL graft. A more horizontal femoral graft position showed significantly increased tracer uptake within the superior and posterior femoral regions. A more posteriorly-placed femoral insertion site showed significantly more tracer uptake within the femoral and tibial tunnel regions. A more vertical or a less medial tibial tunnel orientation showed significant increased uptake within the tibial and femoral tunnel regions. A more anterior tibial tunnel position showed significantly more tracer uptake in the femoral and tibial tunnel regions as well as the entire tibiofemoral joint. SPECT/CT tracer uptake intensity and distribution showed a significant correlation with the femoral and tibial tunnel position and orientation in patients with symptomatic knees after ACL reconstruction. No correlation was found with stability or clinical laxity. SPECT/CT tracer uptake distribution has the potential to give us important information on joint homeostasis and remodelling after ACL reconstruction. It might help to predict ACL graft failure and improve our surgical ACL reconstruction technique in finding the optimal tunnel and graft position and orientation.

Probing the kinetic stabilities of Friedreich's ataxia clinical variants using a solid phase GroEL chaperonin capture platform.

PubMed

Correia, Ana R; Naik, Subhashchandra; Fisher, Mark T; Gomes, Cláudio M

2014-10-20

Numerous human diseases are caused by protein folding defects where the protein may become more susceptible to degradation or aggregation. Aberrant protein folding can affect the kinetic stability of the proteins even if these proteins appear to be soluble in vivo. Experimental discrimination between functional properly folded and misfolded nonfunctional conformers is not always straightforward at near physiological conditions. The differences in the kinetic behavior of two initially folded frataxin clinical variants were examined using a high affinity chaperonin kinetic trap approach at 25 °C. The kinetically stable wild type frataxin (FXN) shows no visible partitioning onto the chaperonin. In contrast, the clinical variants FXN-p.Asp122Tyr and FXN-p.Ile154Phe kinetically populate partial folded forms that tightly bind the GroEL chaperonin platform. The initially soluble FXN-p.Ile154Phe variant partitions onto GroEL more rapidly and is more kinetically liable. These differences in kinetic stability were confirmed using differential scanning fluorimetry. The kinetic and aggregation stability differences of these variants may lead to the distinct functional impairments described in Friedreich's ataxia, the neurodegenerative disease associated to frataxin functional deficiency. This chaperonin platform approach may be useful for identifying small molecule stabilizers since stabilizing ligands to frataxin variants should lead to a concomitant decrease in chaperonin binding.

Influence of freeze-drying and γ-irradiation in preclinical studies of flurbiprofen polymeric nanoparticles for ocular delivery using d-(+)-trehalose and polyethylene glycol

PubMed Central

Ramos Yacasi, Gladys Rosario; García López, María Luisa; Espina García, Marta; Parra Coca, Alexander; Calpena Campmany, Ana Cristina

2016-01-01

This study investigated the suspension of poly(ε-caprolactone) nanoparticles as an ocular delivery system for flurbiprofen (FB-PεCL-NPs) in order to overcome the associated problems, such as stability, sterility, tolerance, and efficacy, with two different FB-PεCL-NP formulations. The formulations were stabilized with poloxamer 188 (1.66% and 3.5%) and submitted individually for freeze-drying and γ-irradiation with polyethylene glycol 3350 (PEG3350) and d-(+)-trehalose (TRE). Both formulations satisfied criteria according to all physicochemical parameters required for ocular pharmaceuticals. The FB-PεCL-NP formulations showed non-Newtonian behavior and sustained drug release. Ex vivo permeation analysis using isolated ocular pig tissues suggested that the presence of PEG3350 results in a reduction of FB transcorneal permeation. Moreover, TRE improved the penetration of FB across the cornea, especially after γ-irradiation. In addition, both formulations did not show a significant affinity in increasing FB transscleral permeation. Both formulations were classified as nonirritating, safe products for ophthalmic administration according to hen’s egg test-chorioallantoic membrane and Draize eye test. Furthermore, an in vivo anti-inflammatory efficacy test showed that irradiated FB-PεCL-NPs prepared with PEG3350 (IR-NPsPEG) have longer anti-inflammatory effects than those presented with irradiated FB-PεCL-NPs prepared with TRE (IR-NPsTRE). IR-NPsPEG showed a suitable physical stability after an aqueous reconstitution over >30 days. This study concludes that both formulations meet the Goldman’s criteria and demonstrate how irradiated nanoparticles, with innovative permeation characteristics, could be used as a feasible alternative to a flurbiprofen solution for ocular application in clinical trials. PMID:27601897

Influence of freeze-drying and γ-irradiation in preclinical studies of flurbiprofen polymeric nanoparticles for ocular delivery using d-(+)-trehalose and polyethylene glycol.

PubMed

Ramos Yacasi, Gladys Rosario; García López, María Luisa; Espina García, Marta; Parra Coca, Alexander; Calpena Campmany, Ana Cristina

This study investigated the suspension of poly(ε-caprolactone) nanoparticles as an ocular delivery system for flurbiprofen (FB-PεCL-NPs) in order to overcome the associated problems, such as stability, sterility, tolerance, and efficacy, with two different FB-PεCL-NP formulations. The formulations were stabilized with poloxamer 188 (1.66% and 3.5%) and submitted individually for freeze-drying and γ-irradiation with polyethylene glycol 3350 (PEG3350) and d-(+)-trehalose (TRE). Both formulations satisfied criteria according to all physicochemical parameters required for ocular pharmaceuticals. The FB-PεCL-NP formulations showed non-Newtonian behavior and sustained drug release. Ex vivo permeation analysis using isolated ocular pig tissues suggested that the presence of PEG3350 results in a reduction of FB transcorneal permeation. Moreover, TRE improved the penetration of FB across the cornea, especially after γ-irradiation. In addition, both formulations did not show a significant affinity in increasing FB transscleral permeation. Both formulations were classified as nonirritating, safe products for ophthalmic administration according to hen's egg test-chorioallantoic membrane and Draize eye test. Furthermore, an in vivo anti-inflammatory efficacy test showed that irradiated FB-PεCL-NPs prepared with PEG3350 (IR-NPsPEG) have longer anti-inflammatory effects than those presented with irradiated FB-PεCL-NPs prepared with TRE (IR-NPsTRE). IR-NPsPEG showed a suitable physical stability after an aqueous reconstitution over >30 days. This study concludes that both formulations meet the Goldman's criteria and demonstrate how irradiated nanoparticles, with innovative permeation characteristics, could be used as a feasible alternative to a flurbiprofen solution for ocular application in clinical trials.

Finite element analysis on the biomechanical stability of open porous titanium scaffolds for large segmental bone defects under physiological load conditions.

PubMed

Wieding, Jan; Souffrant, Robert; Mittelmeier, Wolfram; Bader, Rainer

2013-04-01

Repairing large segmental defects in long bones caused by fracture, tumour or infection is still a challenging problem in orthopaedic surgery. Artificial materials, i.e. titanium and its alloys performed well in clinical applications, are plenary available, and can be manufactured in a wide range of scaffold designs. Although the mechanical properties are determined, studies about the biomechanical behaviour under physiological loading conditions are rare. The goal of our numerical study was to determine the suitability of open-porous titanium scaffolds to act as bone scaffolds. Hence, the mechanical stability of fourteen different scaffold designs was characterized under both axial compression and biomechanical loading within a large segmental distal femoral defect of 30mm. This defect was stabilized with an osteosynthesis plate and physiological hip reaction forces as well as additional muscle forces were implemented to the femoral bone. Material properties of titanium scaffolds were evaluated from experimental testing. Scaffold porosity was varied between 64 and 80%. Furthermore, the amount of material was reduced up to 50%. Uniaxial compression testing revealed a structural modulus for the scaffolds between 3.5GPa and 19.1GPa depending on porosity and material consumption. The biomechanical testing showed defect gap alterations between 0.03mm and 0.22mm for the applied scaffolds and 0.09mm for the intact bone. Our results revealed that minimizing the amount of material of the inner core has a smaller influence than increasing the porosity when the scaffolds are loaded under biomechanical loading. Furthermore, an advanced scaffold design was found acting similar as the intact bone. Copyright © 2012 IPEM. Published by Elsevier Ltd. All rights reserved.

The effect of prolonged storage and disinfection on the dimensional stability of 5 vinyl polyether silicone impression materials

PubMed Central

Flores-Mir, Carlos; Heo, Giseon; Torrealba, Ysidora

2017-01-01

PURPOSE Vinyl polyether silicone (VPES) has a different composition from other elastomeric impression materials as it combines vinyl polysiloxane (VPS) and polyether (PE). Therefore, it is important to study its properties and behavior under different test conditions. This study investigated the dimensional stability of 5 VPES consistencies when stored for up to 2 weeks, with and without using a standard disinfection procedure. MATERIALS AND METHODS 40 discs of each VPES consistency (total 200) were made using a stainless steel die and ring as described by ANSI /ADA specification No. 19. 20 discs of each material were immersed in a 2.5% buffered glutaraldehyde solution for 30 minutes. Dimensional stability measurements were calculated immediately after fabrication and repeated on the same discs after 7 and 14 days of storage. The data was analyzed using two-way ANOVA with a significance level set at α = 0.05. RESULTS The discs mean contraction was below 0.5% at all test times ranging from 0.200 ± 0.014 to 0.325 ± 0.007. Repeated measures ANOVA showed a statistically significant difference after 2-week storage between the disinfected and non-disinfected groups (P < .001). Although there was no statistically significant difference between the materials at the time of fabrication, the contraction of the materials increased with storage for 1 and 2 weeks. CONCLUSION The dimensional changes of VPES impression discs after disinfection and prolonged storage complied with ANSI/ADA standard. The tested VPES impression materials were dimensionally stable for clinical use after disinfection for 30 minutes in glutaraldehyde and storage for up to 2 weeks. PMID:28680549

Fixation parameter test-retest repeatability of the worse eye in central field loss.

PubMed

Samet, Saba; Tarita-Nistor, Luminita; González, Esther G; Mandelcorn, Mark S; Mandelcorn, Efrem D; Steinbach, Martin J

2018-06-01

Patients with bilateral central field loss develop peripheral retinal loci (PRLs) in the functional eccentric retina. PRL characteristics and visual performance in the better-seeing eye (BE) of these patients have previously been reported. In this study, we determined the test-retest repeatability of fixation parameters, including fixation stability, PRL eccentricity, and PRL span in the worse-seeing eye (WE). Retrospective consecutive case series. Thirty-six patients with bilateral central field loss referred from the Toronto Western Hospital Retina Clinic, who had completed 2 consecutive fixation examinations on the same day. Fixation stability was recorded using the Nidek MP-1 microperimeter (Nidek Technologies Srl., Padova, Italy). For each fixation recording, the following parameters were retrieved: (i) 68.2% bivariate contour ellipse area (BCEA), (ii) PRL span (major and minor axes of the BCEA), (iii) PRL meridian (polar angle), and (iv) PRL eccentricity. Test-retest repeatability for each parameter was assessed using Bland-Altman plots to determine 95% limits of agreement. The mean difference between the fixation trial pairs and the 95% limits of agreement for fixation stability, PRL major axis, PRL minor axis, PRL meridian, and PRL eccentricity were 0.06 ± 0.47 log deg 2 , 0.05° ± 1.42°, 0.07° ± 0.63°, -0.44° ± 66.0°, and -0.23° ±1.56°, respectively. The fixation parameters in the WE showed robust repeatability, comparable to that of the BE as determined from previous studies. The WE's fixation repeatability should be considered in the interpretation of fixation outcome measures subsequent to treatment interventions. Crown Copyright © 2018. Published by Elsevier Inc. All rights reserved.

Robot-aided in vitro measurement of patellar stability with consideration to the influence of muscle loading.

PubMed

Lorenz, Andrea; Bobrowitsch, Evgenij; Wünschel, Markus; Walter, Christian; Wülker, Nikolaus; Leichtle, Ulf G

2015-07-23

Anterior knee pain is often associated with patellar maltracking and instability. However, objective measurement of patellar stability under clinical and experimental conditions is difficult, and muscular activity influences the results. In the present study, a new experimental setting for in vitro measurement of patellar stability was developed and the mediolateral force-displacement behavior of the native knee analyzed with special emphasis on patellar tilt and muscle loading. In the new experimental setup, two established testing methods were combined: an upright knee simulator for positioning and loading of the knee specimens, and an industry robot for mediolateral patellar displacement. A minimally invasive coupling and force control mechanism enabled unconstrained motion of the patella as well as measurement of patellar motion in all six degrees of freedom via an external ultrasonic motion-tracking system. Lateral and medial patellar displacement were measured on seven fresh-frozen human knee specimens in six flexion angles with varying muscle force levels, muscle force distributions, and displacement forces. Substantial repeatability was achieved for patellar shift (ICC(3,1) = 0.67) and tilt (ICC(3,1) = 0.75). Patellar lateral and medial shift decreased slightly with increasing flexion angle. Additional measurement of patellar tilt provided interesting insights into the different displacement mechanisms in lateral and medial directions. For lateral displacement, the patella tilted in the same (lateral) direction, and tilted in the opposite direction (again laterally) for medial displacement. With regard to asymmetric muscle loading, a significant influence (p < 0.03, up to 5 mm shift and 8° tilt) was found for lateral displacement and a reasonable relationship between muscle and patellar force, whereas no effect was visible in the medial direction. The developed experimental setup delivered reproducible results and was found to be an excellent testing method for the in vitro analysis of patellar stability and future investigation of surgical techniques for patellar stabilization and total knee arthroplasty. We demonstrated a significant influence of asymmetric quadriceps loading on patellar stability. In particular, increased force application on the vastus lateralis muscle led to a clear increase of lateral patellar displacement.

Stable Versus Unstable Grade II High Ankle Sprains: A Prospective Study Predicting the Need for Surgical Stabilization and Time to Return to Sports.

PubMed

Calder, James D; Bamford, Richard; Petrie, Aviva; McCollum, Graham A

2016-04-01

To investigate grade II syndesmosis injuries in athletes and identify factors important in differentiating stable from dynamically unstable ankle sprains and those associated with a longer time to return to sports. Sixty-four athletes with an isolated syndesmosis injury (without fracture) were prospectively assessed, with a mean follow-up period of 37 months (range, 24 to 66 months). Those with an associated deltoid ligament injury or osteochondral lesion were included. Those whose injuries were considered stable (grade IIa) were treated conservatively with a boot and rehabilitation. Those whose injuries were clinically unstable underwent arthroscopy, and if instability was confirmed (grade IIb), the syndesmosis was stabilized. Clinical and magnetic resonance imaging assessments of injury to individual ligaments were recorded, along with time to return to play. A power analysis estimated that each group would need 28 patients. All athletes returned to the same level of professional sport. The 28 patients with grade IIa injuries returned at a mean of 45 days (range, 23 to 63 days) compared with 64 days (range, 27 to 104 days) for those with grade IIb injuries (P < .0001). There was a highly significant relationship between clinical and magnetic resonance imaging assessments of ligament injury (anterior tibiofibular ligament [ATFL], anterior-inferior tibiofibular ligament [AITFL], and deltoid ligament, P < .0001). Instability was 9.5 times as likely with a positive squeeze test and 11 times as likely with a deltoid injury. Combined injury to the anterior-inferior tibiofibular ligament and deltoid ligament was associated with a delay in return to sports. Concomitant injury to the ATFL indicated a different mechanism of injury-the syndesmosis is less likely to be unstable and is associated with an earlier return to sports. A positive squeeze test and injury to the ATFL and deltoid ligament are important factors in differentiating stable from dynamically unstable grade II injuries and may be used to identify which athletes may benefit from early arthroscopic assessment and stabilization. They may also be important in predicting the time frame for athletes' expected return to play. Level II, prospective comparative study. Copyright © 2016 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Comparative effectiveness of lumbar stabilization, dynamic strengthening, and Pilates on chronic low back pain: randomized clinical trial

PubMed Central

Bhadauria, Esha A.; Gurudut, Peeyoosha

2017-01-01

The aim of the present study was to compare three different forms of exercises namely lumbar stabilization, dynamic strengthening, and Pilates on chronic low back pain (LBP) in terms of pain, range of motion, core strength and function. In this study, 44 subjects suffering from non-specific LBP for more than 3 months were randomly allocated into the lumbar stabilization group, the dynamic strengthening group, and the Pilates group. Ten sessions of exercises for 3 weeks were prescribed along with interferential current and hot moist pack. Pain was assessed by visual analog scale, functional affection by modified Oswestry Disability Questionnaire, range of motion by assessing lumbar flexion and extension by modified Schober test and core strength was assessed by pressure biofeedback on day 1 and day 10 of the treatment. There was reduction of pain, improvement in range of motion, functional ability and core strength in all the 3 exercise groups. The improvement was significantly greater in the lumbar stabilization group for all the outcome measures, when compared the posttreatment after 10th session. Pairwise comparison showed that there was greater reduction of disability in the Pilates group than the dynamic strengthening group. It was concluded that the lumbar stabilization is more superior compared to the dynamic strengthening and Pilates in chronic nonspecific LBP. However, long-term benefits need to be assessed and compared with prospective follow-up studies. PMID:29114516

Reuse of Boron Waste as an Additive in Road Base Material

PubMed Central

Zhang, Yutong; Guo, Qinglin; Li, Lili; Jiang, Ping; Jiao, Yubo; Cheng, Yongchun

2016-01-01

The amount of boron waste increases year by year. There is an urgent demand to manage it in order to reduce the environmental impact. In this paper, boron waste was reused as an additive in road base material. Lime and cement were employed to stabilize the waste mixture. Mechanical performances of stabilized mixture were evaluated by experimental methods. A compaction test, an unconfined compressive test, an indirect tensile test, a modulus test, a drying shrinkage test, and a frost resistance test were carried out. Results indicated that mechanical strengths of lime-stabilized boron waste mixture (LSB) satisfy the requirements of road base when lime content is greater than 8%. LSB can only be applied in non-frozen regions as a result of its poor frost resistance. The lime–cement-stabilized mixture can be used in frozen regions when lime and cement contents are 8% and 5%, respectively. Aggregate reduces the drying shrinkage coefficient effectively. Thus, aggregate is suggested for mixture stabilization properly. This work provides a proposal for the management of boron waste. PMID:28773539

Passive Magnetic Bearing With Ferrofluid Stabilization

NASA Technical Reports Server (NTRS)

Jansen, Ralph; DiRusso, Eliseo

1996-01-01

A new class of magnetic bearings is shown to exist analytically and is demonstrated experimentally. The class of magnetic bearings utilize a ferrofluid/solid magnet interaction to stabilize the axial degree of freedom of a permanent magnet radial bearing. Twenty six permanent magnet bearing designs and twenty two ferrofluid stabilizer designs are evaluated. Two types of radial bearing designs are tested to determine their force and stiffness utilizing two methods. The first method is based on the use of frequency measurements to determine stiffness by utilizing an analytical model. The second method consisted of loading the system and measuring displacement in order to measure stiffness. Two ferrofluid stabilizers are tested and force displacement curves are measured. Two experimental test fixtures are designed and constructed in order to conduct the stiffness testing. Polynomial models of the data are generated and used to design the bearing prototype. The prototype was constructed and tested and shown to be stable. Further testing shows the possibility of using this technology for vibration isolation. The project successfully demonstrated the viability of the passive magnetic bearing with ferrofluid stabilization both experimentally and analytically.

Correlation between plasma homocysteine levels and craving in alcohol dependent stabilized patients.

PubMed

Coppola, Maurizio; Mondola, Raffaella

2018-06-01

Homocysteine is a sulfur amino acid strictly related with alcohol consumption. In alcoholics, hyperhomocysteinemia can increase the risk of various alcohol-related disorders such as: brain atrophy, epileptic seizures during withdrawal, and mood disorders. To evaluate the correlation among serum homocysteine concentrations, craving, hazardous and harmful patterns of alcohol consumption in patients stabilized for withdrawal symptoms. Participants were adult outpatients accessed at the Addiction Treatment Unit. Alcoholism was assessed using the following tools: Mini-International Neuropsychiatric Interview Plus (MINI Plus), Alcohol Use Disorder Identification test (AUDIT), Visual Analogic Scale for craving (VAS). Furthermore, during the first visit a blood sample was taken from all patients to measure the plasma concentration of both homocysteine and Carboxy Deficient Transferrin (CDT). Differences between groups in socio-demographic and clinical characteristics were analyzed using the t-test and the Mann-Whitney's U test for normally and non-normally distributed data, respectively. Correlation between clinical scale scores and plasma concentration of homocysteine and CDT was evaluated using the Pearson's correlation coefficient and the Kendall's Tau-b bivariate correlation coefficient for normally and non-normally distributed data, respectively. Our study included 92 patients. No difference was found in socio-demographic characteristics between groups. The group with high homocysteine had higher prevalence of mood disorders (p < 0.001), plasma CDT percentage (p < 0.001), VAS score (p < 0.001) and AUDIT score (p < 0.001) than group with normal homocysteine. Plasma homocysteine showed a positive correlation with both VAS score (p < 0.001), and AUDIT score (p < 0.05). In our study, plasma homocysteine concentration is associated with craving, hazardous and harmful patterns of alcohol consumption. In particular, homocysteine is correlated with alcoholism in a bidirectional manner because its level appears to be related with alcohol degree, but simultaneously, hyperhomocysteinemia could enhance the alcohol consumption increasing the severity of craving in a circular self reinforcing mechanism. Copyright © 2017 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Acute hepatitis: a rare complication of Epstein-Barr virus (EBV) infection.

PubMed

Uluğ, Mehmet; Celen, Mustafa Kemal; Ayaz, Celal; Geyik, Mehmet Faruk; Hoşoğlu, Salih

2010-10-28

Infectious Mononucleosis (IM), a benign lymphoproliferative disease, is the best known clinical syndrome caused by Epstein-Barr Virus (EBV). It usually resolves over a period of weeks or months without sequelae but may occasionally be complicated by a wide variety of neurologic, hematologic, hepatic, respiratory, and psychological complications. In this report we describe a patient with acute hepatitis following EBV-IM in a previously healthy woman. A 26-year-old woman who presented with fever, generalized weakness, nausea, sore throat, yellowing of skin, and a generalized skin rash was admitted to our clinic. Tonsillar enlargement, pharyngeal erythema, palatal petechiae, lymphadenopathy, and jaundice were noted. Significant atypical lymphocytes ( > 10%) were seen on the peripheral blood smear. Liver function tests such as ALT: 303 U/L, AST: 172 U/L, ALP: 193 U/L and total bilirubin: 7.3 mg/dl were elevated. Serological tests for EBV infection were consistent with acute infection (EBV virus capsid antigen was reactive with IgM and IgG antibodies). The Monospot test was also positive. On the seventh day, liver function tests and bilirubin had risen to peak level and platelets were decreased. The patient was managed supportively and her critical condition improved and was finally stabilized. Although the prognosis for IM is very favorable, a variety of acute complications may occur.

Bon-EV: an improved multiple testing procedure for controlling false discovery rates.

PubMed

Li, Dongmei; Xie, Zidian; Zand, Martin; Fogg, Thomas; Dye, Timothy

2017-01-03

Stability of multiple testing procedures, defined as the standard deviation of total number of discoveries, can be used as an indicator of variability of multiple testing procedures. Improving stability of multiple testing procedures can help to increase the consistency of findings from replicated experiments. Benjamini-Hochberg's and Storey's q-value procedures are two commonly used multiple testing procedures for controlling false discoveries in genomic studies. Storey's q-value procedure has higher power and lower stability than Benjamini-Hochberg's procedure. To improve upon the stability of Storey's q-value procedure and maintain its high power in genomic data analysis, we propose a new multiple testing procedure, named Bon-EV, to control false discovery rate (FDR) based on Bonferroni's approach. Simulation studies show that our proposed Bon-EV procedure can maintain the high power of the Storey's q-value procedure and also result in better FDR control and higher stability than Storey's q-value procedure for samples of large size(30 in each group) and medium size (15 in each group) for either independent, somewhat correlated, or highly correlated test statistics. When sample size is small (5 in each group), our proposed Bon-EV procedure has performance between the Benjamini-Hochberg procedure and the Storey's q-value procedure. Examples using RNA-Seq data show that the Bon-EV procedure has higher stability than the Storey's q-value procedure while maintaining equivalent power, and higher power than the Benjamini-Hochberg's procedure. For medium or large sample sizes, the Bon-EV procedure has improved FDR control and stability compared with the Storey's q-value procedure and improved power compared with the Benjamini-Hochberg procedure. The Bon-EV multiple testing procedure is available as the BonEV package in R for download at https://CRAN.R-project.org/package=BonEV .

78 FR 63019 - Safety Standard for Bassinets and Cradles

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-23

... directly attributable to product stability, the instability of the product, in many incidents, was to blame... stability test procedure, and (2) the addition of new provisions for a segmented mattress flatness test and a removable bed stability requirement. In this document, the Commission is issuing a safety standard...

Test-retest reliability and gender differences in the sexual discounting task among cocaine-dependent individuals.

PubMed

Johnson, Matthew W; Bruner, Natalie R

2013-08-01

The Sexual Discounting Task uses the delay discounting framework to examine sexual HIV risk behavior. Previous research showed task performance to be significantly correlated with self-reported HIV risk behavior in cocaine dependence. Test-retest reliability and gender differences had remained unexamined. The present study examined the test-retest reliability of the Sexual Discounting Task. Cocaine-dependent individuals (18 men, 13 women) completed the task in two laboratory visits ∼7 days apart. Participants selected photographs of individuals with whom they were willing to have casual sex. Among these, participants identified the individual most (and least) likely to have a sexually transmitted infection (STI), and the individual with whom he or she most (and least) wanted to have sex. In reference to these individuals, participants rated their likelihood of having unprotected sex versus waiting to have sex with a condom, at various delays. A money delay discounting task was also completed at the first visit. Significant differences in discounting among partner conditions were shown. Differential stability was demonstrated by significant, positive correlations between test and retest for all four partner conditions. Absolute stability was demonstrated by statistical equivalence tests between test and retest, and also supported by a lack of significant differences between test and retest. Men generally discounted significantly more than women for sexual outcomes but not money. Results suggest the Sexual Discounting Task to be a reliable measure in cocaine-dependent individuals, which supports its use as a repeated measure in clinical research, for example, studies examining acute drug effects on sexual risk and the effects of addiction treatment and HIV prevention interventions on sexual risk. PsycINFO Database Record (c) 2013 APA, all rights reserved

Paclitaxel Albumin-stabilized Nanoparticle Formulation

Cancer.gov

This page contains brief information about paclitaxel albumin-stabilized nanoparticle formulation and a collection of links to more information about the use of this drug, research results, and ongoing clinical trials.

Y balance test has no correlation with the Stability Index of the Biodex Balance System.

PubMed

Almeida, Gabriel Peixoto Leão; Monteiro, Isabel Oliveira; Marizeiro, Débora Fortes; Maia, Laísa Braga; de Paula Lima, Pedro Olavo

2017-02-01

A cross-sectional study design. The Stability Index of the Biodex Balance System (SI-BBS) and Y Balance Test (YBT) has been used in studies assessing postural stability but no studies have verified the association of the YBT with the SI-BBS. To analyze the association of the Y Balance Test (YBT) with the Stability Index of the Biodex Balance System (SI-BBS) to evaluate postural stability. Forty participants who engaged in recreational physical activities, 12 of whom had a history of injury to the lower limbs. Was used the SI-BBS and the anterior, posterolateral, posteromedial, and composite measures of the YBT. The order of execution of the tests and of the lower limbs evaluated was randomized and blind tested by two evaluators. Pearson's correlation coefficient was used to check the strength of the relationship between the distances achieved on the YBT and the SI-BBS. The YBT showed excellent reliability in the anterior, posteromedial, and posterolateral directions. However, the YBT showed no statistically significant correlation with any variables in the SI-BBS, indicating poor validity between YBT and SI-BBS assessments of postural stability in people with and without history of lower limb injuries. The results of this study showed the YBT is not correlated with the SI-BBS as an assessment of postural stability. This finding has implications for researchers and clinicians using YBT results as the only measure of postural stability. Copyright © 2016 Elsevier Ltd. All rights reserved.

Soil-Geosynthetic Interaction Test to Develop Specifications for Geosynthetic-Stabilized Roadways

DOT National Transportation Integrated Search

2018-05-01

soil-geosynthetic composite (KSGC) for a wide range of geosynthetics. The tests were conducted after establishment of test configurations that were found suitable for specification of geosynthetic-stabilized base roadways. Field performance of experi...

Stability of 21 Cocaine, Opioid and Benzodiazepine Drug Analytes in Spiked Meconium at Three Temperatures.

PubMed

Wu, Fang; Marin, Stephanie J; McMillin, Gwendolyn A

2017-04-01

In this study, the stability of 21 cocaine, opioid and benzodiazepine analytes in spiked meconium was investigated at three storage temperatures: 4°C, room temperature (RT), and 37°C (body temperature). The drugs/metabolites included were hydrocodone, hydromorphone, codeine, morphine, 6-acetylmorphine (6-AM), oxycodone, oxymorphone, cocaine, cocaethylene, benzoylecgonine, m-hydroxybenzoylecgonine, diazepam, oxazepam, temazepam, nordiazepam, chlordiazepoxide, lorazepam, alprazolam, alpha-hydroxyalprazolam, clonazepam, 7-aminoclonazepam, midazolam, alpha-hydroxymidazolam and zolpidem. Drug testing was performed using mass spectrometry methods that were validated for clinical use. After 2 weeks of storage, a substantial loss was observed in the concentrations of 7-aminoclonazepam (48.4% at 4°C and 71.5% at RT), and chlordiazepoxide (59.5% at RT). A slight decrease was observed in the concentrations of alprazolam (20.9% at 4°C), clonazepam (24.5% at 4°C), chlordiazepoxide (23.5% at 4°C), midazolam (20.8% at 4°C), nordiazepam (22.8% at RT), and alpha-hydroxyalprazolam (20.7% at 4°C). At 37°C, the concentrations of chlordiazepoxide, 7-aminoclonazepam, lorazepam, oxazepam, nordiazepam and temazepam decreased by 81.4%, 86.8%, 56.5%, 59.9%, 45.4% and 31.7%, respectively, after 2 weeks. 6-AM was observed to be unstable regardless of storage temperatures. For morphine, a 33.3% increase at 4°C and a 23.4% increase at RT were observed after 2 weeks, respectively, possibly due to 6-AM degradation, while no changes ≥20% were observed at 37°C. All other analytes were stable up to 2 weeks at all three storage temperatures (concentration changes <20%). The stability of select drug analytes in authentic clinical meconium specimens was consistent with that observed in spiked meconium. In conclusion, some drugs in meconium may not be stable for long periods of time. Sample storage conditions are an important consideration in the context of detection windows and interpreting drug-testing results in meconium. To the best of our knowledge, this is the first stability study of cocaine, opioids and benzodiazepines in meconium concerning the effects of storage temperatures. © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Synergistic interactions of blood-borne immune cells, fibroblasts and extracellular matrix drive repair in an in vitro peri-implant wound healing model

NASA Astrophysics Data System (ADS)

Burkhardt, Melanie A.; Waser, Jasmin; Milleret, Vincent; Gerber, Isabel; Emmert, Maximilian Y.; Foolen, Jasper; Hoerstrup, Simon P.; Schlottig, Falko; Vogel, Viola

2016-02-01

Low correlations of cell culture data with clinical outcomes pose major medical challenges with costly consequences. While the majority of biomaterials are tested using in vitro cell monocultures, the importance of synergistic interactions between different cell types on paracrine signalling has recently been highlighted. In this proof-of-concept study, we asked whether the first contact of surfaces with whole human blood could steer the tissue healing response. This hypothesis was tested using alkali-treatment of rough titanium (Ti) surfaces since they have clinically been shown to improve early implant integration and stability, yet blood-free in vitro cell cultures poorly correlated with in vivo tissue healing. We show that alkali-treatment, compared to native Ti surfaces, increased blood clot thickness, including platelet adhesion. Strikingly, blood clots with entrapped blood cells in synergistic interactions with fibroblasts, but not fibroblasts alone, upregulated the secretion of major factors associated with fast healing. This includes matrix metalloproteinases (MMPs) to break down extracellular matrix and the growth factor VEGF, known for its angiogenic potential. Consequently, in vitro test platforms, which consider whole blood-implant interactions, might be superior in predicting wound healing in response to biomaterial properties.

Balance and Risk of Fall in Individuals with Bilateral Mild and Moderate Knee Osteoarthritis

PubMed Central

Khalaj, Nafiseh; Abu Osman, Noor Azuan; Mokhtar, Abdul Halim; Mehdikhani, Mahboobeh; Wan Abas, Wan Abu Bakar

2014-01-01

Balance is essential for mobility and performing activities of daily living. People with knee osteoarthritis display impairment in knee joint proprioception. Thus, the aim of this study was to evaluate balance and risk of fall in individuals with bilateral mild and moderate knee osteoarthritis. Sixty subjects aged between 50 and 70 years volunteered in this study. They were categorized into three groups which were healthy (n = 20), mild (n = 20) and moderate (n = 20) bilateral knee osteoarthritis groups. Dynamic and static balance and risk of fall were assessed using Biodex Stability System. In addition, Timed Up and Go test was used as a clinical test for balance. Results of this study illustrated that there were significant differences in balance (dynamic and static) and risk of fall between three groups. In addition, the main (most significant) difference was found to be between healthy group and moderate group. Furthermore, on clinical scoring of balance, the “Timed Up and Go” test, all three groups showed significant difference. In conclusion, bilateral knee osteoarthritis impaired the balance and increased the risk of fall, particularly in people with moderate knee osteoarthritis. PMID:24642715

Balance and risk of fall in individuals with bilateral mild and moderate knee osteoarthritis.

PubMed

Khalaj, Nafiseh; Abu Osman, Noor Azuan; Mokhtar, Abdul Halim; Mehdikhani, Mahboobeh; Wan Abas, Wan Abu Bakar

2014-01-01

Balance is essential for mobility and performing activities of daily living. People with knee osteoarthritis display impairment in knee joint proprioception. Thus, the aim of this study was to evaluate balance and risk of fall in individuals with bilateral mild and moderate knee osteoarthritis. Sixty subjects aged between 50 and 70 years volunteered in this study. They were categorized into three groups which were healthy (n = 20), mild (n = 20) and moderate (n = 20) bilateral knee osteoarthritis groups. Dynamic and static balance and risk of fall were assessed using Biodex Stability System. In addition, Timed Up and Go test was used as a clinical test for balance. Results of this study illustrated that there were significant differences in balance (dynamic and static) and risk of fall between three groups. In addition, the main (most significant) difference was found to be between healthy group and moderate group. Furthermore, on clinical scoring of balance, the "Timed Up and Go" test, all three groups showed significant difference. In conclusion, bilateral knee osteoarthritis impaired the balance and increased the risk of fall, particularly in people with moderate knee osteoarthritis.

Prospective, randomized, controlled comparison of SYSTANE UD eye drops versus VISINE INTENSIV 1% EDO eye drops for the treatment of moderate dry eye.

PubMed

Jacobi, Christina; Kruse, Friedrich E; Cursiefen, Claus

2012-12-01

The aim of this prospective, randomized, clinical, single-center study was to compare the safety and efficacy of 2 ocular surface lubricant eye drops: preservative-free hydroxypropyl (HP)-Guar (SYSTANE UD(®)) eye drops versus preservative-free Tamarindus indica seed polysaccharide (TSP) 1% (VISINE INTENSIV 1% EDO(®)) eye drops. Fifty-six eyes of 28 patients with moderate keratoconjunctivitis sicca (DEWS severity level 2) were enrolled in the trial. Patients were randomized for 2 treatment groups (SYSTANE UD eye drops vs. VISINE INTENSIV 1% EDO eye drops). The eye drops in both groups were applied 5 times per day for 3 months. Statistical analyses were performed using Statistica™ software (Mann-Whitney U-test and Wilcoxon test). P-Values<0.05 were considered significant. After 3 months of treatment the patients of both groups had subjective benefit in the relief of symptoms of dry eye disease evaluated by the Ocular Surface Disease Index (OSDI) questionnaire score. Patients treated with HP-Guar and TSP showed improvements in tear film stability measured by tear break-up time (TBUT), which are statistically significant in the HP-Guar group (P=0.02). The results of this clinical trial show improvements of symptoms and signs in patients with moderate dry eye after the consistent use of preservative-free HP-Guar and TSP lubricant eye drops. Both artificial tear formulations produce amelioration in tear film stability improving eye conditions and patient quality of life. HP-Guar seems to be slightly more effective in improving ocular surface protection by decreasing tear film evaporation.

Postural stability in a population of dancers, healthy non-dancers, and vestibular neuritis patients.

PubMed

Martin-Sanz, Eduardo; Ortega Crespo, Isabel; Esteban-Sanchez, Jonathan; Sanz, Ricardo

2017-09-01

Several studies have indicated better balance control in dancers than in control participants, but some controversy remains. The aim of our study is to evaluate the postural stability in a cohort of dancers, non-dancers, compensated, and non-compensated unilateral vestibular neuritis (VN). This is a prospective study of control subjects, dancers, and VN patients between June 2009 and December 2015. Dancers from the Dance Conservatory of Madrid and VN patients were referred to our department for analysis. After the clinical history, neuro-otological examination, audiogram, and caloric tests, the diagnosis was done. Results from clinical examination were used for the categorization of compensation situation. A computerized dynamic posturography was performed to every subject. Forty dancers and 38 women formed both 'dancer' and 'normal' cohorts. Forty-two compensated and 39 uncompensated patients formed both 'compensated' and 'uncompensated' cohorts. Dancers had significantly greater antero-posterior (AP) body sway than controls during condition 5 and 6 in the Sensory Organization Test (SOT) (p < .05). When we compared the uncompensated cohort with both control and dancers groups, we found significant greater body sway in every SOT studied condition (p < .05). While mean AP body say in SOT 5 and 6, showed greater values in compensated patients than the control group, the mean analysis did not show any statistical difference between the compensated and dancer groups, in such SOT conditions. Dancers demonstrated greater sways than non-dancers when they relied their postural control on vestibular input alone. Compensated patients had a similar posturographic pattern that the dancers cohort, suggesting a similar shift from visual to somatosensory information.

Alzheimer disease-like clinical phenotype in a family with FTDP-17 caused by a MAPT R406W mutation.

PubMed

Lindquist, S G; Holm, I E; Schwartz, M; Law, I; Stokholm, J; Batbayli, M; Waldemar, G; Nielsen, J E

2008-04-01

We report clinical, molecular, neuroimaging and neuropathological features of a Danish family with autosomal dominant inherited dementia, a clinical phenotype resembling Alzheimer's disease and a pathogenic mutation (R406W) in the microtubule associated protein tau (MAPT) gene. Pre-symptomatic and affected family members underwent multidisciplinary (clinical, molecular, neuroimaging and neuropathological) examinations. Treatment with memantine in a family member with early symptoms, based on the clinical phenotype and the lack of specific treatment, appears to stabilize the disease course and increase the glucose metabolism in cortical and subcortical areas, as determined by serial [F(18)]FDG-PET scanning before and after initiation of treatment. Neuropathological examination of a second affected and mutation-positive family member showed moderate atrophy of the temporal lobes including the hippocampi. Microscopy revealed abundant numbers of tau-positive neurofibrillary tangles in all cortical areas and in some brainstem nuclei corresponding to a diagnosis of frontotemporal lobe degeneration on the basis of a MAPT mutation. The clinical and genetic heterogeneity of autosomal dominant inherited dementia must be taken into account in the genetic counselling and genetic testing of families with autosomal dominantly inherited dementia in general.

An In Vitro Robotic Assessment of the Anterolateral Ligament, Part 2: Anterolateral Ligament Reconstruction Combined With Anterior Cruciate Ligament Reconstruction.

PubMed

Nitri, Marco; Rasmussen, Matthew T; Williams, Brady T; Moulton, Samuel G; Cruz, Raphael Serra; Dornan, Grant J; Goldsmith, Mary T; LaPrade, Robert F

2016-03-01

Recent biomechanical studies have demonstrated that an extra-articular lateral knee structure, most recently referred to as the anterolateral ligament (ALL), contributes to overall rotational stability of the knee. However, the effect of anatomic ALL reconstruction (ALLR) in the setting of anterior cruciate ligament (ACL) reconstruction (ACLR) has not been biomechanically investigated or validated. The purpose of this study was to investigate the biomechanical function of anatomic ALLR in the setting of a combined ACL and ALL injury. More specifically, this investigation focused on the effect of ALLR on resultant rotatory stability when performed in combination with concomitant ACLR. It was hypothesized that ALLR would significantly reduce internal rotation and axial plane translation laxity during a simulated pivot-shift test compared with isolated ACLR. Controlled laboratory study. Ten fresh-frozen cadaveric knees were evaluated with a 6 degrees of freedom robotic system. Knee kinematics were evaluated with simulated clinical examinations including a simulated pivot-shift test consisting of coupled 10-N·m valgus and 5-N·m internal rotation torques, a 5-N·m internal rotation torque, and an 88-N anterior tibial load. Kinematic differences between ACLR with an intact ALL, ACLR with ALLR, and ACLR with a deficient ALL were compared with the intact state. Single-bundle ACLR tunnels and ALLR tunnels were placed anatomically according to previous quantitative anatomic attachment descriptions. Combined anatomic ALLR and ACLR significantly improved the rotatory stability of the knee compared with isolated ACLR in the face of a concurrent ALL deficiency. During a simulated pivot-shift test, ALLR significantly reduced internal rotation and axial plane tibial translation when compared with ACLR with an ALL deficiency. Isolated ACLR for the treatment of a combined ACL and ALL injury was not able to restore stability of the knee, resulting in a significant increase in residual internal rotation laxity. ALLR did not affect anterior tibial translation; no significant differences were observed between the varying ALL conditions with ACLR except between ACLR with an intact ALL and ACLR with a deficient ALL at 0° of flexion. In the face of a combined ACL and ALL deficiency, concurrent ACLR and ALLR significantly improved the rotatory stability of the knee compared with solely reconstructing the ACL. Significant increases in residual internal rotation and laxity during the pivot-shift test may exist in both acute and chronic settings of an ACL deficiency and in patients treated with isolated ACLR for a combined ACL and ALL deficiency. For this subset of patients, surgical treatment of the ALL, in addition to ACLR, should be considered to restore knee stability. © 2016 The Author(s).

The clinical effectiveness and cost-effectiveness of the PROGENSA® prostate cancer antigen 3 assay and the Prostate Health Index in the diagnosis of prostate cancer: a systematic review and economic evaluation.

PubMed

Nicholson, Amanda; Mahon, James; Boland, Angela; Beale, Sophie; Dwan, Kerry; Fleeman, Nigel; Hockenhull, Juliet; Dundar, Yenal

2015-10-01

There is no single definitive test to identify prostate cancer in men. Biopsies are commonly used to obtain samples of prostate tissue for histopathological examination. However, this approach frequently misses cases of cancer, meaning that repeat biopsies may be necessary to obtain a diagnosis. The PROGENSA(®) prostate cancer antigen 3 (PCA3) assay (Hologic Gen-Probe, Marlborough, MA, USA) and the Prostate Health Index (phi; Beckman Coulter Inc., Brea, CA, USA) are two new tests (a urine test and a blood test, respectively) that are designed to be used to help clinicians decide whether or not to recommend a repeat biopsy. To evaluate the clinical effectiveness and cost-effectiveness of the PCA3 assay and the phi in the diagnosis of prostate cancer. Multiple publication databases and trial registers were searched in May 2014 (from 2000 to May 2014), including MEDLINE, EMBASE, The Cochrane Library, ISI Web of Science, Medion, Aggressive Research Intelligence Facility database, ClinicalTrials.gov, International Standard Randomised Controlled Trial Number Register and World Health Organization International Clinical Trials Registry Platform. The assessment of clinical effectiveness involved three separate systematic reviews, namely reviews of the analytical validity, the clinical validity of these tests and the clinical utility of these tests. The assessment of cost-effectiveness comprised a systematic review of full economic evaluations and the development of a de novo economic model. The perspective of the evaluation was the NHS in England and Wales. Men suspected of having prostate cancer for whom the results of an initial prostate biopsy were negative or equivocal. The use of the PCA3 score or phi in combination with existing tests (including histopathology results, prostate-specific antigen level and digital rectal examination), multiparametric magnetic resonance imaging and clinical judgement. In addition to documents published by the manufacturers, six studies were identified for inclusion in the analytical validity review. The review identified issues concerning the precision of the PCA3 assay measurements. It also highlighted issues relating to the storage requirements and stability of samples intended for analysis using the phi assay. Fifteen studies met the inclusion criteria for the clinical validity review. These studies reported results for 10 different clinical comparisons. There was insufficient evidence to enable the identification of appropriate test threshold values for use in a clinical setting. In addition, the implications of adding either the PCA3 assay or the phi to clinical assessment were not clear. Furthermore, the addition of the PCA3 assay or the phi to clinical assessment plus magnetic resonance imaging was not found to improve discrimination. No published papers met the inclusion criteria for either the clinical utility review or the cost-effectiveness review. The results from the cost-effectiveness analyses indicated that using either the PCA3 assay or the phi in the NHS was not cost-effective. The main limitations of the systematic review of clinical validity are that the review conclusions are over-reliant on findings from one study, the descriptions of clinical assessment vary widely within reviewed studies and many of the reported results for the clinical validity outcomes do not include either standard errors or confidence intervals. The clinical benefit of using the PCA3 assay or the phi in combination with existing tests, scans and clinical judgement has not yet been confirmed. The results from the cost-effectiveness analyses indicate that the use of these tests in the NHS would not be cost-effective. This study is registered as PROSPERO CRD42014009595. The National Institute for Health Research Health Technology Assessment programme.

Impact of Storage Time on Hepatitis B Virus DNA Stability in Clinical Specimens Determined by Quantitative Real-time PCR.

PubMed

Zhang, Xiaolian; Yang, Dongmei; Lu, Yu; Lao, Xianjun; Qin, Xue; Li, Shan

2016-01-01

Detecting blood levels of hepatitis B virus (HBV) DNA must be accurate and credible. Shipment and storage conditions of clinical samples affect the quality of nucleic acids and can interfere with HBV DNA analysis. The aim of our study was to compare HBV DNA stability in plasma specimens at 4 degrees C for different storage periods. Blood samples from 30 hepatitis B surface antigen (HBsAg) positive patients were collected in tubes containing EDTA-K2. Each sample was divided into eight aliquots, one of which was measured immediately for the initial viral load. The remaining aliquots were then stored at 4 degrees C and assessed after 1, 2, 3, 7, 14, 21, and 30 days of storage. Quantification of HBV DNA was performed by real-time polymerase chain reaction (RT-PCR), and the difference in HBV DNA concentrations between two different time points was analysed with a paired-samples t-test. HBV DNA was measured in a range of 2.00 - 8.00 IU/mL, with low within-run and between-run coefficients of variation (< 10%). Storing plasma for one month at 4 degrees C revealed no significant decrease in HBV DNA level (p = 0.231), and no trend was evident to indicate continued reduction over a 3-week storage period. Based on the results of this study, storing plasma for up to one month at 4 degrees C does not affect the stability of HBV DNA, regardless of the initial viral load.