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Clinical overall score: outcome evaluation after lumbar disc surgery, assessments of reliability and validity.

In previous studies assessing prognostic factors for the outcome of lumbar disc surgery, a Clinical Overall Score (COS) based on four subsets-pain intensity (VAS), physical signs, functional status (Oswestry) and analgesics--was used as the main outcome criterion. Both the patient's and the examiner's opinions of outcome and return to work were registered. In this paper, assessments are made of reliability and validity regarding the COS. The COS was found sensitive to changes, and internal consistency, assessed using Cronbach's alpha, Pearson's correlation analyses and factor analysis, was good. An interrater reliability study of the assessments of the physical signs, using weighted Kappa statistics, demonstrated fair to good levels of agreement for most of the signs. The concurrent validity of the COS was satisfactory; COS compared favourably with the patient's and with the examiner's opinion of outcome and return to work.

Adult↗

Compositional analysis of commercial PVC bottles and studies of aspects of specific and overall migration into foods and stimulants.

Plastics additives and processing aids present severe difficulties for the legislator attempting to establish meaningful controls. In many cases information both on the substances added to the plastic and on the species migrating into food, which may well be different, are lacking. In the studies reported, information has been sought on the actual components employed in two typical commercial plastics. Analysis has been carried out of both the composition and trace constituents of the ingredients of commercial PVC formulations used for manufacturing bottles for orange squash and cooking oil applications. Assessment of maximum leachable material was made by solvent extraction of the individual additives, which was compared with overall migration from the PVC bottles into food stimulants using proposed EEC Statutory Methods. Additionally, specific migration measurements of epoxidized soyabean oil, tris(nonylphenyl) phosphite, nonylphenol, pentaerythritol, and BHT antioxidant were carried out in food stimulants and where possible also in foods.

Chemical Phenomena↗

Overall migration and specific migration of bisphenol A diglycidyl ether monomer and m-xylylenediamine hardener from an optimized epoxy-amine formulation into water-based food simulants.

The overall and specific migrations of BADGE n = 0 monomer and m-XDA hardener from a BEPOX LAB 889 (Gairesa internal code), epoxy system cured at room temperature, into three water-based food simulants are studied. Hydrolysis of BADGE n = 0 was observed in all of these simulants, giving more polar products. We thus propose changing the EEC Directives, which at present only legislate for levels of BADGE n = 0 monomer in the simulants, to include the hydrolysis products of BADGE monomers. Another alternative would be to express all the migration levels due to BADGE and its derived products in terms of BADGE itself.

Benzhydryl Compounds↗

Spontaneous subarachnoid haemorrhage in the era of transition from surgery to embolization. A study of the overall outcome.

The aim of the investigation was to evaluate the outcome of spontaneous subarachnoid haemorrhage, in the era of new techniques, patient centralization and subspecialization, by taking into account the local conditions in Greece. A prospective observational study was conducted during a 4-year period. All patients with a first-ever spontaneous subarachnoid haemorrhage were enrolled. Clinical, management and outcome data were recorded. Two-hundred-and-eighteen consecutive patients with an 81% good, medium clinical grade (Hunt & Hess I-III) were identified. Rebleed and rebleed leading to death rates were 22 and 11%, respectively. Permanent deficit or death from vasospasm was 15%. Twenty-eight per cent of the study population died early, were unsuitable for further management (poor clinical status, advanced age) or declined angiography or treatment, and another 22% had a negative angiogram. The remaining 50% underwent intervention (neurosurgical/endovascular), for obliteration of an aneurysm. The overall favourable 6-month outcome was 59%, whereas the favourable outcome of the intervention group was 70%. Our results confirm the findings of previous series. The relatively worse results are due to delayed referral, and lack of availability of surgical or endovascular management in the early post-haemorrhage period (28% of the patients), particularly in potentially salvageable cases. On the basis of these observations, we recommend early intervention (surgery or embolization) and centralization/subspecialization, in order to improve the outcome.

Adolescent↗

The Swedish National Care Programme for Anal Carcinoma--implementation and overall results.

The Swedish National Care Programme for Anal Carcinoma (SNCPAC) was instituted in order to create a uniform handling policy for anal cancer and thus to accrue a population-based material allowing unbiased analyses. This study evaluates the degree of implementation of the SNCPAC guidelines, and presents overall treatment results in a total of 356 patients with epidermoid cancer of the anus and the perianal region diagnosed in Sweden between 1985 and 1989. Primary treatment according to the guidelines was irradiation up to 40 Gy, Bleomycin was administered intramuscularly before the first 18 fractions. After a 3-week pause, radiotherapy was to be continued up to a dose of 60-64 Gy, if at least an almost complete response was achieved. Otherwise, the patient was recommended surgery within a week. The guidelines were applied in 90%, of cases where such treatment was possible. The 5-year tumour-specific survival rate was 72%. The survival rate was more favourable in perianal tumours (90%) than in anal canal tumours (68%, p < 0.01). The 5-year probability of having a preserved anus was 64% (anal canal/perianal 58%/91%, p < 0.001). Bleomycin did not appear to have any effect on treatment results. The care programme has had a rapid and almost complete nation-wide penetration, and h as created the desired uniformity allowing proper analyses. The treatment results also appear comparable with specialised referral centres.

Adult↗

Pitfalls in estimating the influence of overall treatment time on local tumor control.

Variations in the overall treatment time of human tumors occur for a number of reasons: differences in standard treatment schedules among centers, occurrence of public holidays during treatment, machine maintenance or breakdown, and decisions made by physicians to change treatment for individual patients based on patient or tumor response. It is now widely accepted that tumor proliferation can occur during treatment, and many efforts have been made to quantify the effects of varying the treatment time. Some of the many problems associated with obtaining quantitative estimates of the time factor are discussed. The aim of this paper is to illustrate that estimates of the time factor for tumor repopulation should be regarded with skepticism and used with extreme caution.

Appointments and Schedules↗

Internal dynamics and overall motion of lysozyme studied by fluorescence depolarization of the eosin lysozyme complex.

Time-resolved fluorescence depolarization on the nanosecond and sub-nanosecond time scales is a powerful technique for the study of rapid motions in the condensed phase. We apply this technique to measure the motions of proteins using both extrinsic and intrinsic probes. Eosin, which absorbs and fluoresces in the visible, forms a one-to-one complex with lysozyme binding in the hydrophobic box region and is used as an extrinsic probe of lysozyme motion. The long-time anisotropy of bound eosin is used to measure the overall rotation time of lysozyme for which refined values are presented. In addition, our measurements show a rapid restricted motion of the eosin molecule on the time scale of approximately 100 ps. The order parameter, a model independent measure of the extent of the restriction of the rapid motions, decreases with increasing temperature, indicating that the motion of the eosin is less hindered as temperature increases. We compare our results with the crystallographic measurements of least square displacements for the hydrophobic box region. Our measurements provide direct time resolved confirmation that the displacements observed in this region correspond to rapid motion.

Binding Sites↗

Overall false positive rates in tests for linear trend in tumor incidence in animal carcinogenicity studies of new drugs.

Based on results of simulation and empirical studies conducted within the Divisions of Biometrics, Center for Drug Evaluation and Research, Food and Drug Administration, and in collaboration with the National Toxicology Program, the Center has recently changed the significance levels for testing positive linear trend in incidence rate for common and rare tumors, respectively, from 0.01 and 0.05 to 0.005 and 0.025. The overall false positive rate resulting from the use of this new rule in the tests for linear trend in a two-species-two-sex study is about 10%, the rate that is judged as the most appropriate in a regulatory setting by the Center. This paper describes two of the studies.

Animals↗

Endometrial safety, overall safety and tolerability of transdermal continuous combined hormone replacement therapy over 96 weeks: a randomized open-label study.

OBJECTIVES: To establish whether transdermal continuous hormone replacement therapy (HRT) with estrogen/progestogen provides adequate long-term endometrial protection in postmenopausal women over a period of 96 weeks. METHODS: This multicenter, randomized, open-label, parallel-group study evaluated the endometrial effects and overall safety and tolerability of a transdermal matrix patch delivering estradiol (E2) 50 microg/day and norethisterone acetate (NETA) 140 microg/day (Estalis; patches applied twice weekly without intermediate breaks) and a once-daily oral comparator (Kliogest; one tablet containing E2 2 mg/NETA 1 mg) in postmenopausal women. A total of 406 women with an intact uterus, aged 44-69 years, were randomized in the 48-week core phase of the study, and 239 continued into the 48-week extension phase. Subjects were randomized in the ratio 3 : 1 to transdermal or oral E2/NETA treatment. RESULTS: No cases of endometrial hyperplasia or endometrial cancer were reported with either treatment during the core or extension phase. Both treatments were generally well tolerated, with most adverse events (>90%) being mild to moderate, although minor differences in the tolerability profile were observed between treatments. CONCLUSIONS: Continuous combined transdermal HRT with E2/NETA shows no evidence of an increased endometrial hyperplasia or endometrial cancer risk over a 96-week period.

Administration, Cutaneous↗

Comparison of the overall intelligibility, articulation, resonance, and voice characteristics between children using cochlear implants and those using bilateral hearing aids: a pilot study.

The purpose of this study was to determine and to compare the overall intelligibility, articulation, resonance, and voice characteristics in children using cochlear implants (CI) and children using conventional hearing aids (HA). Nine prelingually deaf children using CI and six children with a prelingual severe hearing loss using HA, were selected to participate. Objective (DSI, nasalance scores) as well as subjective assessment techniques (perceptual evaluations) were used. Both the CI and HA children demonstrated normal vocal quality and resonance but showed the presence of articulation disorders. In the CI children, intelligibility was significantly better compared to the HA children. Significantly more phonetic and phonological disorders were present in the HA children. The results of this study show a poorer intelligibility of the HA children in comparison with the CI children which is probably due to the occurrence of significantly more phonetic and phonological disorders. Future detailed analysis in a larger sample of CI and HA children may help further clarify the issue of speech and voice characteristics and may demonstrate an important prognostic value.

Adolescent↗

The influence of humidity on the overall mass transfer coefficient of the Wheeler-Jonas equation.

The Wheeler-Jonas model is well known for its good prediction of breakthrough times for organic vapors on activated carbon beds. However, it is valid only in dry conditions: no prewetting of the filter and no humidity in the ambient air during use. One of the parameters that is likely to be influenced is the overall mass transfer coefficient kv. By measuring over 200 breakthrough times, with 7 different vapors on 4 different types of activated carbon, a simple but satisfactory model for the influence of moisture on kv was established. The only items of information needed, compared with the application of the Wheeler-Jonas equation under dry circumstances, are the water isotherm and the total pore volume of the activated carbon.

Adsorption↗

Estimating the overall mass transfer coefficient k(v) of the Wheeler-Jonas equation: a new and simple model.

The modified Wheeler-Jonas model is well known for its good prediction of breakthrough times for organic vapors on activated carbon beds. To use this model adequately one must estimate the overall adsorption rate coefficient kv. In this work a new equation is proposed to calculate kv. The relevant parameters of this equation are the airstream velocity, the affinity constant beta of the organic vapor, and the mean diameter of the carbon particles. Very accurate predictions were obtained for breakthrough times on a wide range of carbons using the calculated values of kv. Compared with other models, this model shows a higher accuracy and a lower degree of uncertainty.

Adsorption↗

The design of child restraint system (CRS) labels and warnings affects overall CRS usability.

A study was conducted that assessed the effectiveness of different child restraint system (CRS) label/warning designs on users' installation performance. Forty-eight paid participants installed a convertible CRS in a vehicle, and two child test dummies in a CRS, using one of four label conditions. The label conditions were: (1) no labels, (2) the manufacturer's labels that were already affixed to the CRS ("Current"), (3) labels that were designed according to a combination of the current U.S. regulations concerning CRS labels and recently proposed changes to these regulations ("Proposed"), and (4) labels that were designed according to human factors principles and guidelines, and that were based on a hierarchical behavioral task analysis ("Optimal"). Results demonstrated that, overall, the Optimal labels resulted in higher usability ratings and better task performance. This indicates that labels designed using human factors and task analyses that identify critical task information requirements for label features will result in increased user compliance with instructions, higher usability, and improved task performance. Surprisingly, having no labels on the CRS resulted in better installation performance than when either the Current or the Proposed label conditions were used. This indicates that label design can decrease task performance; the actual physical design of a CRS may be just as critical as label content in the installation choices provided to the user. Collectively, results suggest that implementation of the proposed changes to the U.S. regulations concerning CRS labeling would likely not result in increased performance or usability compared to existing manufacturer labels that follow the current guidelines. In order to achieve significantly better ease-of-use and task performance, it would be necessary to implement features of the Optimal label condition.

Adult↗

Requirements of Kettin, a giant muscle protein highly conserved in overall structure in evolution, for normal muscle function, viability, and flight activity of Drosophila.

Kettin is a giant muscle protein originally identified in insect flight muscle Z-discs. Here, we determined the entire nucleotide sequence of Drosophila melanogaster kettin, deduced the amino acid sequence of its protein product (540 kD) along with that of the Caenorhabditis elegans counterpart, and found that the overall primary structure of Kettin has been highly conserved in evolution. The main body of Drosophila Kettin consists of 35 immunoglobulin C2 domains separated by spacers. The central two thirds of spacers are constant in length and share in common two conserved motifs, putative actin binding sites. Neither fibronectin type III nor kinase domains were found. Kettin is present at the Z-disc in several muscle types. Genetic analysis showed that kettin is essential for the formation and maintenance of normal sarcomere structure of muscles and muscle tendons. Accordingly, embryos lacking kettin activity cannot hatch nor can adult flies heterozygous for the kettin mutation fly.

Amino Acid Sequence↗

Mutation rates in humans. I. Overall and sex-specific rates obtained from a population study of hemophilia B.

A population-based study of hemophilia B mutations was conducted in the United Kingdom in order to construct a national confidential database of mutations and pedigrees to be used for the provision of carrier and prenatal diagnoses based on mutation detection. This allowed the direct estimate of overall (micro), male (v), and female (u) mutation rates for hemophilia B. The values obtained per gamete per generation and the 95% confidence intervals are micro;=7.73 (6. 29-9.12&parr0;x10-6; v=18.8 (14.5-22.9&parr0;x10-6; and u=2.18 (1. 44-3.16&parr0;x10-6. The ratio of male-to-female mutation rates is 8. 64, with a 95% confidence interval of 5.46-14.5. The higher male rate was not caused by a much higher rate of transition at CpG sites in the male. Attempts to detect evidence of gonadal mosaicism for hemophilia B mutation in suitable families did not detect any instances of ovarian mosaicism in any of 47 available opportunities. This suggests that the risk of a noncarrier mother manifesting as a gonadal mosaic by transmitting the mutation to a second child should be <0.062.

CpG Islands↗

Influence of angle between the nozzle and skin surface on the heat flux and overall heat extraction during cryogen spray cooling.

High speed video imaging and an inverse heat conduction problem algorithm were used to observe and measure the effect of the angle between the nozzle and surface of a skin phantom on: (a) surface temperature; (b) heat flux q; and (c) overall heat extraction Q during cryogen spray cooling (CSC). A skin phantom containing a fast-response temperature sensor was sprayed with 50 ms cryogen spurts from a commercial nozzle placed 30 mm from the surface. The nozzle was systematically positioned at angles ranging from 5 to 90 degrees (perpendicular) with respect to the phantom surface. It is shown that angles as low as 15 have an insignificant impact on the surface temperature, q and Q. Only exaggerated angles of 5 show up to 10% lower q and 30% lower Q with respect to the maximal values measured when nozzles are aimed perpendicularly. This study proves that the slight angle that many commercial nozzles have does not affect significantly the CSC efficiency.

Algorithms↗

Divalproex sodium reduces overall aggression in youth at high risk for bipolar disorder.

INTRODUCTION: The psychopharmacology of aggression in youth is relatively unexplored, even though such maladaptive aggression manifests across many different diagnoses. METHODS: This study was a 12-week, open-label trial with divalproex sodium (DVPX) in 24 bipolar offspring 6-18 years of age (mean age = 11.3 years; 17 boys) with mixed diagnoses of major depression, cyclothymia, attention-deficit/hyperactivity disorder (ADHD), and oppositional defiant disorder (ODD). The Overt Aggression Scale (OAS) was used to measure aggression in 4-week intervals. We measured serum gamma-butyric acid (GABA) and glutamate levels at baseline and week 12. RESULTS: Seventy-one percent of evaluable subjects were considered responders to DVPX treatment by the OAS. There was a significant correlation between the Young Mania Rating Scale (YMRS) and OAS scores at week 0 (p = 0.036) and week 12 (p = 0.025). Serum DVPX level did not correlate with treatment response. CONCLUSIONS: These youths who are at high risk for bipolar disorder experienced an overall decrease in aggressive behavior in response to DVPX. Age or gender did not predict a positive response to DVPX. This study is the first report of treatment efficacy of a mood stabilizer for aggression in youth at high risk for bipolar disorder.

Adolescent↗

Overall protein content and induced enzyme components of the periplasm of Bacillus subtilis.

Estimates for the overall protein content of the periplasm of Escherichia coli range from 4 to 16% of cellular protein. A cursory examination of known sources of contamination inherent to the methods employed for measurement leads to the conclusion that even the lower value may represent an overestimate of the periplasmic protein in E. coli. The protoplast supernatant fraction (PSF) of Bacillus subtilis defines operationally a potential periplasm, which, after correction for cytoplasmic contamination, yielded, in B. subtilis strains 168 and W23, calculated values of 9 and 3%, respectively, of cell protein as being periplasmic. 26 Among enzymes typically periplasmic in E. coli, at least two, RNases and a 5'-nucleotidase, were located in the B. subtilis periplasm. Compared to other cell fractions, RNase activity in the periplasm was associated with several protein bands forming a unique profile. Samples from all growth phases of cells cultured under phosphate-limitation and phosphate-excess revealed that a major part of both investigated activities was induced by phosphate depletion and located outside the plasma membrane. The current belief that a periplasm containing soluble enzymes does not exist in gram-positive bacteria is examined in light of the absence of an outer membrane permeability barrier, and of a clearly defined electron-transparent zone located between the plasma membrane and the cell wall of B. subtilis. Previous results of studies of protein secretion, and cell wall permeability, are reinterpreted by assuming that the thick charged cell wall of gram-positive bacteria can act as the outer permeability barrier, and as such be the functional equivalent of the outer membrane of gram-negative organisms.

Bacillus subtilis↗