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PubMed2003

The EAMG position on the regulation of existing products for treatment with special reference to named patient products (NPPs).

Allergen products have a long history in both diagnosis and management of allergic disease. It is emphasized that the availability of named patient products presents a valuable and indispensable option for the effective and safe treatment of patients suffering from IgE-mediated allergic diseases. A regulatory climate should be achieved in which these products can survive until a safe and effective alternative is borne out. Within the context of the paper the following definition is used: A named patient product or NPP is an allergen product, prepared with a specific reference number in accordance with a prescription for an individual patient, identified by the name of this patient and the reference number, and delivered after control of consistency with previous treatments. It is stressed that the standards of quality that hold for registered products are also applicable for named patient preparations which, for various reasons, can not be filed for registration. The paper frequently refers to a Position Paper that has recently been adopted by the European Allergen Manufacturers Group, the EAMG. The presentation breaks a lance for a concerted approach of the NPP-concept by striving at harmonization of legal, regulatory, manufacturing, and distribution conditions.

Allergens↗
PubMedDate not supplied

[Performance of carriers and non-carriers of the E280A mutation for familial Alzheimer's disease in a naming test].

INTRODUCTION: Early preclinical diagnosis is the greatest challenge faced by researchers into dementia. Cognitive, neuroanatomical, neurophysiological and genetic markers have been reported. One of the preclinical cognitive markers is anomia and it is often assessed using visual naming tests. AIMS: The aim of this study was to analyse the type of mistakes made in a visual naming test in a group of carriers and non-carriers of the E280A PS1 mutation. PATIENTS AND METHODS: The sample was made up of 91 participants who were genotyped for the E280A PS1 mutation and divided into three groups: non-carriers (n = 30), asymptomatic carriers (n = 39) and sick carriers (n = 22). Selection was performed using the Minimental and the Fast and EDG scales and mistakes in the CERAD naming test were classified. The types of mistakes taken into account were: no answer, visual, semantic, phonological, the whole for the part, and not related. RESULTS: There is a significant difference in the number of semantic errors between non-carriers and asymptomatic carriers; on comparing the three groups, no statistically significant differences were found in visual mistakes. CONCLUSIONS: Visual mistakes are a general characteristic, even in healthy subjects and, therefore, these errors did not provide any information that could be used to classify patients with or without dementia. Semantic mistakes can be considered as being a preclinical sign in familial Alzheimer's disease (FAD). Both visual and auditory naming tests must be applied when evaluating patients with FAD.

Adult↗
PubMed2004

Trends in manufacturer prices of brand name prescription drugs used by older Americans--first quarter 2004 update.

This Issue Brief reports on changes in manufacturers' prescription drug prices during the first three months of 2004 (January through March) for the brand name prescription drugs most widely used by Americans age 50 and over. This report is the first quarterly update in an ongoing study of changes in drug manufacturer prices-that is, manufacturers' prices charged for drugs they sold to wholesalers. A baseline study published in May 2004 by the AARP Public Policy Institute identified steady increases in the average annual manufacturer price from calendar year 2000 through calendar year 2003. This report's focus is on changes in the prices that brand name drug manufacturers charge to wholesalers for sales to retail pharmacies. The manufacturer's charge to wholesalers is the most substantial component of a prescription drug's retail price. When there is an increase in the manufacturer price to wholesalers for a brand name drug, this added cost is generally passed on as a similar percent change in the retail price to most prescription purchasers. The report presents three measures of price change (see methodological appendix). The first set of findings are annual rates of change in manufacturers' prices for widely used brand name drugs, using both rolling average and point-to-point estimates; information is presented on percentage change in manufacturer price and on potential dollar changes in consumer spending. The second set of findings are three-month percentage changes in prices (i.e., changes from December 31, 2003 through March 31, 2004); the distribution of percentage price changes is shown, as well as differences in average percentage price changes by manufacturer and by therapeutic category.

Aged↗
PubMedDate not supplied

[Crepidulospora--nomen novum for the junior generic homonym (preoccupied generic name) Crepidula].

Crepidulospora nom. nov. is a replacement generic name for the genus Crepidula Simakova, Pankova et Issi, 2003 based on the type species Crepidula beklemishevi Simakova, Pankova et Issi, 2003 (Microsporida) from Anopheles beklemishevi. The name proposed by Simakova et al., 2003 is a preoccupied name, because it was already used for the gastropode Crepidula Lamarque 1899 (Echinospirida, Calibraeidae), a parasite of Mytilus. A valid name of the type species of the genus is now Crepidulospora beklemishevi (Simakova, Pankova, Issi, 2003) comb. n. Crepidulospora Simakova, Pankova et Issi nom. non. Type species: Crepidula beklemishevi Simakova, Pankova, Issi, 2003. Diagnosis. Sporogony is octosporoblastic. Sporogonal stages are in direct contact with host cell cytoplasm. 8 uninucleate spores, 4.2 x 2.2 mkm, are sandals-like. Polar tube is anisofilar, with 6-7 coils (2 + 4-5). Polaroplast is three-partite, with broad vesicular, vesicular and lamellar compartments. Microsporidia ilnfects larval adipose tissues. Type host: Anopheles beklemishevi (Diptera, Culicidae).

Animals↗
PubMed2006

Naming, blaming and shaming?

Few doctors at the centre of complaints or disciplinary proceedings wish to be publicly named. Publication of a doctor's name can adversely affect his or her reputation, patients, and family members, even if the allegation is ultimately not upheld. Yet, there is a strong public interest in freedom of speech and transparency of complaints and disciplinary processes. In determining whether to grant name suppression, complaints agencies and disciplinary tribunals are required to balance competing public and private interests. In New Zealand, the Health and Disability Commissioner has responsibility for investigating complaints about the quality of medical care. The Commissioner's current practice is not to publicly name doctors under investigation, or even those who are found to have breached a patient's rights. This approach fits well the non-punitive, rehabilitative focus of New Zealand's medical regulatory system. In the rare cases where a matter reaches the threshold for disciplinary action, the balance tips in favour of disclosure.

Humans↗
PubMedDate not supplied

[Language and cognitive impairment: a semiological study into visual naming].

INTRODUCTION: The presence of anomia and/or paraphasias in patients with cognitive impairment suggests an associated deterioration of their language. Visual naming makes it possible to examine these signs in a controlled manner as the target word is already known. AIM. To conduct a semiological study of naming in normal aging, cognitive impairment and language impairment conditions. SUBJECTS AND METHODS: The study consisted in an analysis of nine types of signs (correct response, increased latencies, circumlocutions, absence of response, semantic verbal paraphasias, verbal paraphasias with a similar form, unrelated verbal paraphasias, phonemic paraphasias and neologisms) in a visual naming task (6 items), in two groups with normal language--controls > 70 years and patients with Alzheimer's disease (AD) with onset of amnesia--and two groups with language impairment--vascular aphasia and anomic AD-. RESULTS: Patients failed to perform naming correctly in 4.2% of the responses in controls, 10% in patients with amnesic AD, 30% in patients with vascular aphasia and 50% in patients with anomic AD. Semantic paraphasias were observed in the two groups with normal language abilities (controls and amnesic AD), although frequencies were low. Signs that suggest difficulties in accessing/retrieving lexical items were more frequent in patients with AD and ran parallel to the degree of anomia. One notable finding was the absence of signs of phonological dysfunction in the two groups with AD, regardless of the degree of anomia. CONCLUSIONS: Semiological quantification makes it possible to distinguish differences in the degree of anomia and in the pattern of errors both in controls and in patients with amnesic onset AD and among patients with vascular aphasia and neurodegenerative anomia.

Aged↗
PubMed1987

Are generic formulations equivalent to trade name topical glucocorticoids?

Trade name glucocorticoid formulations triamcinolone acetonide, fluocinolone acetonide, and betamethasone valerate were compared with their generic equivalents because of increasing substitution of generic formulations for trade name formulations. The vasoconstrictor assay was the method used for these comparisons. Large differences were found between generic and trade name formulations containing the same steroid in the same concentration in both cream and ointment vehicles. If generic substitutions are to be used for trade name formulations, the physician must be aware that significant differences in therapeutic effectiveness may be expected.

Administration, Topical↗
PubMed1985

Aspects of digit-span performance: naming time and order memory.

Individual differences in digit span, as in any memory span task, can be attributed to item-identification speed (naming time) and memory for order. The relationship between the two was examined in an experiment with 40 EMR and 40 nonretarded children. Order memory and digit span had significant correlations for both groups. Naming time was found to correlate with span only for EMR subjects; span was a linear function of the number of digits named in 2.89 seconds. For nonretarded subjects no relationship between the two was observed. The results for EMR subjects, although interpretable in terms of limited capacity in working memory, were discussed in the context of the substantial correlation between order memory and naming time.

Child↗
PubMed1983

Learning to associate names and faces. Impaired acquisition on an ecologically relevant memory task by male alcoholics.

The performance of a group of detoxified male chronic alcoholics was compared with that of age-matched nonalcoholic controls on a memory task which at face value seemed relevant to daily life--i.e., learning to associate people's names with their faces. The alcoholics not only made more errors while learning the face-name associations than did the controls, but fewer of them were able to reach the learning criterion. However, 1 hour later, the alcoholics were nevertheless able to recognize all of the faces and names used during acquisition. The savings scores for the alcoholics, an index of the relative number of face-name associations retained during the 1-hour interval, did not differ significantly from those of the controls. These results demonstrate that the alcoholics' paired-associate learning deficit on this ecologically relevant task is related to their failure to form associations rather than to deficiencies in recognition memory or perceptual processes.

Age Factors↗
PubMed1980

Investigation of a visual imagery mnemonic device for acquiring face--name associations.

Two studies were conducted on a face--name mnemonic containing several components: a prominent facial feature; a concrete, high imagery transformation of the person's name (e.g., "Bryant" became "bride ant"); and an interactive visual image of these two components. In the first experiment subjects were given one of six strategies for learning face--name associations; the strategies differed with respect to which of the three or combination of the three components were incorporated. Results indicated that all three components of the face--name mnemonic were essential for its effectiveness. The second experiment showed that the cue effectiveness of a facial feature decreased with the frequency of its usage and varied directly with the feature's distinctiveness among all faces in the list.

Discrimination Learning↗
PubMed1980

Potency of brand name and generic levothyroxine.

The tablet thyroxine content of a brand name and two generic products were studied. The mean thyroxine content was significantly different in the generic tablets when compared with that in the brand name product. The coefficient of variation of tablet thyroxine was lowest in the brand name, although this product had only 78% of expected potency. When these products were tested in three hypothyroid patients, two serum free thyroxine indexes were well outside the normal range when the most potent generic product was substituted for the brand name drug. Manufacturers should be required to measure the thyroxine content of their tablets. Until such time that levothyroxine products become more uniform, physicians, pharmacists, and legislators should not encourage product switching.

Humans↗
PubMed1996

Effect of dipyrone, L-NAME and L-arginine on endotoxin-induced rat paw edema.

Paw edema was induced in male Wistar rats (200-250 g) by intraplantar (ipl) administration of 2.5 micrograms endotoxin (Etx). Etx, like carrageenin, produced two distinct edema formation phases, an early phase (75 min) followed by a late phase (7 h). We showed that the edema formation in the early phase was antagonized by dipyrone (80 mg/kg, i.p.) and indomethacin (1 mg/kg, i.p.) by 52% and 55%, respectively, and that the late phase was resistant to these drugs. These results suggest that in the early phase prostaglandins appear to be involved in the process. However, the activation of the kinin cascade leading to the release of other mediators may be involved in the increase of edema in the late phase. To test this hypothesis, we investigated whether the release of nitric oxide (NO) is involved in the mechanism of endotoxin-induced rat paw edema during the late phase, using N omega-nitro-L-arginine methyl ester (L-NAME) (50 micrograms, ipl) as inhibitor of NO synthase and L-arginine (1 mg, ipl) as substrate of NO synthase. The paw edema induced by Etx was inhibited by L-NAME by 56% and increased by L-arginine by 81%. Furthermore, L-arginine given in combination with L-NAME completely reversed the inhibition of Etx-induced edema produced by L-NAME. These results support the hypothesis that in the late phase NO production is associated with the edema evoked by Etx.

Animals↗
PubMed1998

Evaluation of HIV case surveillance through the use of non-name unique identifiers--Maryland and Texas, 1994-1996.

Notifiable disease reporting laws or regulations in states and territories require reporting of acquired immunodeficiency syndrome (AIDS) cases, including patient and physician names, to state or local health authorities. As of January 1, 1998, a total of 31 states were conducting name-based human immunodeficiency virus (HIV) case surveillance by using the same methods as surveillance for AIDS. However, because of concerns about name-based HIV surveillance, Maryland and Texas implemented HIV surveillance using non-name unique identifiers (UI). This report summarizes a 3-year collaboration by CDC and these states to evaluate UI surveillance for HIV infection; the findings indicate some limitations to the use of a Social Security number-based UI for HIV surveillance.

Community Health Services↗
PubMed1998

Effects of sulfated cholecystokinin octapeptide and cholecystokinin tetrapeptide in rat behavior after blockade of nitric oxide synthase by L-NAME.

This study was conducted to determine what, if any, role L-NAME (inhibitor of nitric oxide synthase) plays in the behavioral effects induced by sulfated cholecystokinin octapeptide CCK-8) and cholecystokinin tetrapeptide (CCK-4) in adult male rats. The motility, stereotypy, anxiety, extinction of conditioned avoidance responses and recall of passive avoidance behavior were estimated. CCK-8 (but not CCK-4) injected intracerebroventricularly (icv) at the dose 0.1 nmole decreased of locomotor activity in the "open field" test. Administration of CCK-8 intensified stereotypy evoked by apomorphine (1 mg/kg, i.p.). The CCK-4 was ineffective in this test. Both, CCK-8 and CCK-4 did not make any significant differences in passive avoidance behavior. Examine the influence of CCK-8 and CCK-4 on the extinction of conditioned avoidance responses (CAR) proved that both peptide tended to facilitate extinction of CAR's. CCK-8 and CCK-4 induced anxiogenic-like effect in the elevated 'plus' maze behavior. Application of L-NAME alone (50 nmole,-icv) decreased of motility and stereotypy behavior in control rats. It was ineffective in a passive avoidance behavior and extinction of CAR's. In elevated 'plus' maze behavior injection of L-NAME, similarly to cholecystokinin, induced anxiogenic-like effect. L-NAME induced of motility decreases in the "open field" test were blocked by injection of CCK-8 and CCK-4. Our results indicate that observed behavioral activity of CCK-8 and CCK-4 (except of influence on motility) is probably independent of NO concentration in the brain.

Analysis of Variance↗
PubMed1991

Application of exact ODDS for partial agreements of names in record linkage.

Automated methods for linking records pertaining to the same individuals have in the past made only crude use of the name information. A perceptive filing clerk is more sophisticated because humans retain a lifetime memory of instances in which variant forms of names were employed interchangeably, and of synonyms that sometimes did not even resemble one another. This limitation of the machine can be rectified, but the body of knowledge required to serve as its memory must be large. The needed data have now been brought together on a suitable scale, from many past searches of Canada's Mortality Data Base. Described here are the development and use of the resulting tables of essentially exact discriminating powers (or ODDS) to do with comparisons of male given names. The aim is to reduce the proportion of ambiguously linked pairs of records requiring labor intensive clerical resolution. The tables are intended for general use in this country, and as a model for similar facilities appropriate to other populations.

Canada↗
PubMed2006

Evaluation of techniques for increasing recall in a dictionary approach to gene and protein name identification.

Gene and protein name identification in text requires a dictionary approach to relate synonyms to the same gene or protein, and to link names to external databases. However, existing dictionaries are incomplete. We investigate two complementary methods for automatic generation of a comprehensive dictionary: combination of information from existing gene and protein databases and rule-based generation of spelling variations. Both methods have been reported in literature before, but have hitherto not been combined and evaluated systematically. We combined gene and protein names from several existing databases of four different organisms. The combined dictionaries showed a substantial increase in recall on three different test sets, as compared to any single database. Application of 23 spelling variation rules to the combined dictionaries further increased recall. However, many rules appeared to have no effect and some appear to have a detrimental effect on precision.

Abstracting and Indexing↗
PubMed2005

Hippocampal functional magnetic resonance imaging during a face-name learning task in adolescents with antecedents of prematurity.

Functional magnetic resonance imaging (fMRI) was used to map hippocampal activation during a declarative memory task in a sample of 14 adolescents with antecedents of prematurity (AP). The sample with AP was matched by age, sex and handedness with 14 full-term controls with no history of neurological or psychiatric illness. The target task consisted in learning 16 novel face-name pairs, and the control task involved the examination of two repeated face-name pairs. Stereological methods were also used to quantify hippocampal volumes. In both groups, we observed increased activation in the learning condition compared to the control task in the right fusiform gyrus and the left inferior occipital gyrus, but only premature subjects activated the hippocampus. Group comparison of the activation versus control conditions showed that prematures had greater activity in the right hippocampus than controls during the encoding of the word-face association. Volumetric analyses showed a significant left hippocampal volume loss in adolescents with AP. In addition, we found a significant positive correlation in the premature group between right hippocampal activation and face-name recognition. Functional MRI data also correlated with structural MRI data: right hippocampal activation correlated positively with right hippocampal volume. Our findings are consistent with previous studies of brain plasticity after focal lesions. Left hippocampal tissue loss may be related to an increase in contralateral brain activity, probably reflecting a compensatory mechanism. Our data also suggest that this plasticity is not enough to achieve normal performance.

Adolescent↗
PubMed2004

The semantic organisation of proper nouns: the case of people and brand names.

We describe the performance of a patient (AZ) with a semantic refractory access disorder on a series of experiments probing comprehension of two broad proper noun categories, namely person names and brand names. By inducing and manipulating the semantic relatedness effects which are commonly observed in semantic refractory access patients, we demonstrate that famous person knowledge is primarily organised by occupation, whilst knowledge of brands is organised by product type. For instance, we show that AZ has significantly greater difficulty identifying a famous person from among distractor personalities who have the same occupation (e.g. composers: Beethoven, Mozart, Handel, and Bach) than those who have different occupations (e.g. Beethoven, Picasso, Shakespeare, and Jefferson). We also show that such semantic relatedness effects do not occur when stimuli are grouped by another variable such as nationality. We argue that these semantic distance effects reflect the greater build-up of refractoriness among concepts which are supported by shared neural circuitry. In psychological space, it seems natural that these individuals should be classified in this way. The strength of our findings lie in the fact that this organisation of psychological space is mirrored by neural organisation. Thus, we report a previously undocumented degree of fine-grain organisation within conceptual knowledge of these classes of proper nouns. We also interpret our data as providing the strongest empirical support to date for the semantic module of cognitive models of person recognition.

Aged↗