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PubMed1992

FDA's new drug evaluation process: a general overview.

A general overview of the FDA new-drug evaluation process is presented with special emphasis on the regulatory requirements as outlined in the federal Food, Drug, and Cosmetic Act and the interpretive New Drug Regulations. Included is a description of the administrative/scientific makeup and functions of the new-drug evaluation divisions within the Center for Drug Evaluation and Research. Some specifics relating to the investigative development of anticaries and plaque/gingivitis new drug products are discussed.

Chemical Phenomena↗

PubMed1998

Colony variation in Staphylococcus lugdunensis.

Staphylococcus lugdunensis is being increasingly reported as a pathogen with an outcome resembling that of S. aureus rather than coagulase-negative staphylococci. Recent local isolates exhibited colonial variation that delayed identification and interpretation of clinical significance. Until now previous descriptions have not emphasized colonial variation as an important identifying characteristic of S. lugdunensis.

Down Syndrome↗

PubMed2004

Generalization of features in the assembly neural networks.

The purpose of the paper is an experimental study of the formation of class descriptions, taking place during learning, in assembly neural networks. The assembly neural network is artificially partitioned into several sub-networks according to the number of classes that the network has to recognize. The features extracted from input data are represented in neural column structures of the sub-networks. Hebbian neural assemblies are formed in the column structure of the sub-networks by weight adaptation. A specific class description is formed in each sub-network of the assembly neural network due to intersections between the neural assemblies. The process of formation of class descriptions in the sub-networks is interpreted as feature generalization. A set of special experiments is performed to study this process, on a task of character recognition using the MNIST database.

Algorithms↗

PubMed1993

Restriction to a limited set of EEG-target variables may lead to misinterpretation of pharmaco-EEG results.

The number and types of target variables quantified from the spectrally analyzed EEG used in topographic pharmaco-EEG studies are still being discussed. Drug-induced changes of target variables obtained in the alpha frequency band--four absolute and four relative powers as well as three frequency measures--were utilized to assess the effects of xantinolnicotinate in demented patients using a parallel group design and the effects of buspirone in a double-blind, placebo-controlled crossover design. We conclude that for the proper evaluation of the different drug effects on the alpha activity, all these target variables should be considered. Descriptive p values of multiple comparisons within the framework of descriptive data analyses are important tools in interpreting drug effects.

Adolescent↗

PubMed2005

The validity of DSM-IV dissociative disorders categories in south-west Uganda.

There is little systematic research on the cross-cultural validity of the dissociative disorders, especially in non-western countries. This study evaluates the fit of the DSM-IV classification and concepts of these disorders with local concepts, experiences and local presentations in south-west Uganda. We conducted focus group discussions with medical students, traditional healers, religious leaders, counselors, community members and other health workers (n=48). They were supplemented by key informant interviews with religious people, traditional healers and leaders (n=11). The responses were subjected to thematic analysis. Dissociative amnesia and depersonalization were generally recognized and seen as the result of traumatic experiences and were useful categories in Uganda. However, dissociative fugue did not match local concepts and was confused with spirit possession and other conditions such as alcoholic fugues and dementia. The description of dissociative identity disorder was always interpreted as a possession trance disorder by the local healers. We found only partial support for the validity of the DSM-IV classification of dissociative disorders in Uganda.

Adult↗

PubMedDate not supplied

The stress of dementia: view from the inside.

This descriptive exploratory study used thematic analysis to interpret short videotaped speech samples produced by persons with dementia in response to the question, "How have things been goingforyou lately?" The researchers were able to identify themes in 50 of the 56 interviews with men and women with Mini-Mental State Examination (MMSE) scores that ranged from five to 28. The major themes across all MMSE levels were losses, feelings about losses, and attempts to manage losses. The individuals' choice of themes as well as their verbal and nonverbal expressions suggested that they were experiencing a significant amount of stress, especially related to their relationships with family and friends.

Aged↗

PubMed1996

Outcomes assessment of drug treatment in multiple sclerosis clinical trials.

The purpose of this review is to evaluate the clinical outcomes of drug therapy in the treatment of multiple sclerosis (MS) in those studies which purported to include an assessment of quality of life. Pharmacological management of MS is primarily directed towards control of symptoms and prevention of disease progression or relapse. Although there are many drug and nondrug approaches used in the treatment of MS, this review focuses largely on approaches that incorporate some method of clinical outcome assessment. To aid in the interpretation of the data presented, a short descriptive summary of these assessment methods has been included. Although most studies incorporate at least one clinical outcome measure into the evaluation of efficacy, only one study has examined the economic impact of intervention in MS. The authors of that study demonstrated good correlation between the level of disability assessed using conventional quality-of-life measures and associated healthcare costs. Surprisingly, although many treatment approaches used in MS have significant associated toxicity and only modest benefits in terms of disease control, there is a remarkable paucity of data on the impact of these treatments on patients' quality of life. Studies that incorporate pharmacoeconomic and health-related quality-of-life consequences related to the treatment of MS are required.

Clinical Trials as Topic↗

PubMed1983

Fibroadenoma of the breast: sonomammography correlated with pathology in 122 patients.

During the performance of 2,000 sonomammograms, there were 122 patients with 140 biopsy-confirmed fibroadenomas. Mass lesions or abnormalities were detected on the sonomammograms in 100 of these patients (82%) (118/140 masses), and a retrospective review of the descriptive sonographic criteria tabulated at the initial interpretation of 118 of these masses was undertaken. The most significant sonographic mass features were a round (48%) or oval (37%) shape, a smooth contour (75%), weak internal echoes (80%) in a uniform distribution (88%), and intermediate acoustic attenuation (71%). A pathologist reviewed all the cases, tabulating the gross and microscopic appearance of each specimen. In addition, the average fibrous and epithelial tissue content of 103 tumors (100 fibroadenomas and three adenofibromas) was recorded from a review of five low-power microscopic fields of representative areas of the tumor and correlated with the sonographic features. The sonomammographic features of seven calcified fibroadenomas, five giant fibroadenomas, and one fibroadenoma containing in situ lobular carcinoma and a subgroup having both sonomammograms and radiomammograms are discussed.

Adenofibroma↗

PubMed1997

The interpretation of leukoplakia in laryngeal pathology.

Leukoplakia is only a descriptive clinical term designating a white patch or plaque of the mucosa and must be complemented by histology. On the other hand, keratosis is an exclusively histological term denoting pathological production and accumulation of keratin on the surface of the laryngeal epithelium. Leukoplakia is usually keratosis, but not always. Keratosis can mask various epithelial changes, from simple hyperplasia to invasive squamous carcinoma and is only the superficially visible manifestation of an underlying pathological process. Keratosis means total replacement of superficial epithelial cells by keratin filaments, and dissolution of the nuclei. When nuclei are retained in keratinized cells, the process is termed parakeratosis. Therefore, keratosis can be classified as a separate entity only when histopathological examination reveals superficial keratotic changes accompanying a normal squamous epithelium. To identify the presence of keratosis in various benign laryngeal entities divided according to severity of epithelial abnormalities, and to determine whether keratosis has any prognostic value, we performed a retrospective analysis on bioptic material on 4,291 tissue specimens over a period of 15 years. Our results suggest that keratosis must be considered as only one sign of the disorder within the complex of other pathological changes and not as a distinct pathological entity. For this very reason, keratinization of the epithelial surface was not included among significant parameters used for the grading of epithelial changes into the particular group according to Kambic-Lenart classification.

Epithelium↗

PubMed1981

Binaural interaction of impaired listeners. A review of past research.

This paper reviews past studies of binaural interaction in impaired listeners. The topics covered include localization and lateralization; equal loudness, centering and lateralization adaptation; detection of signals in noise; and discrimination of interaural time delay and interaural amplitude ratio. Comments concerning experimental design and procedures, as well as interpretation of results, are often included with descriptions of the studies.

Auditory Perception↗

PubMed1992

Horner's law. The first step in the history of the understanding of X-linked disorders.

Earlier reports on colour blindness are descriptions which almost always mention the familial occurrence. Horner's publications (1876), however, gave the first scientific analysis of the hereditary transmission of Daltonism. Since this genealogic study was published only in a local bulletin of the City of Zurich it seemed necessary to give a translation of the most important part of the article. 'Horner's law' says that colour-blind fathers have colour-normal daughters; and these colour-normal daughters are the mothers of colour-blind sons. In his first pedigree Horner demonstrates that colour-blindness is transmitted from the grandfather to the grandson. A second pedigree, however, shows the possibility that the transmission is also possible via female carriers through more than one generation. The similarity with the inheritance of haemophilia, published by Lossen (Heidelberg), was mentioned by Horner. In the further progress of genetic research the chromosomes were visualized, at first in tumour-cells 1881, in cells of human tissue. The final point in this development was the description of sex chromosomes, which made the interpretation of Horner's law possible by Wilson (1911), i.e., the localization of the pathologic gene of Daltonism on the X-chromosome.

Color Vision Defects↗

PubMed2006

Toxicology findings in child and adolescent suicides in virginia: 1987-2003.

OBJECTIVE: In a follow-up report of child and adolescent suicides in Virginia, we describe postmortem toxicology findings in a subset of these youths. METHOD: We analyzed "unnatural" deaths from Virginia's Office of the Chief Medical Examiner for 1987 to 2003. There were 2818 unnatural deaths in children and adolescents. We grouped unnatural deaths as accidents, homicides, and suicides. Toxicology records were available for 753 cases, of which 732 were black or white youths. RESULTS: There were no age differences among suicide victims and accident or homicide victims. Whites were more likely than blacks to die by accident and suicide. White females were more likely than black females to commit suicide. Black males were more likely than white males to suffer homicide. For all unexpected deaths, antidepressants were more commonly found among whites than blacks. Suicide by poisoning occurred more commonly among whites. Recreational drugs were more commonly found among blacks than whites. Suicide by gun occurred more commonly among blacks. Antidepressants were found in 39 black and white suicide victims. Anti-depressants (all tricyclic antidepressants) were causally related in 17 cases of suicide by poisoning. No other antidepressants were found in lethal levels in suicide by poisoning. Selective serotonin reuptake inhibitors (SSRIs)/venlafaxine appeared more commonly in the suicides (p < .0001) than in accidents or homicides. For suicides, SSRIs appeared no more commonly in poisoning than in gun or hanging deaths (p = .695). CONCLUSIONS: Antidepressants appeared more commonly among youths committing suicide than those dying by accident or homicide. SSRIs did not appear more commonly among youths committing suicide by poisoning than those committing suicide by gun or hanging. Because our data are descriptive, they are subject to over-interpretation. Cause-effect inferences should not be drawn.

Journal Article↗

PubMed2000

Bacterial thermal death kinetics based on probability distributions: the heat destruction of Clostridium botulinum and Salmonella Bedford.

Despite the long history and excellent record of inactivation models used in thermal processing, there are relatively few approaches that attempt to describe the kinetics commonly observed. There are even fewer examples of models that allow the user to deal with the environmental conditions that influence these kinetics. We describe an approach that assumes a distribution of inactivation times within a population of bacterial cells. The concept allows for alternative interpretations of death kinetics and provides excellent descriptions of data generated with two important foodborne pathogens, Clostridium botulinum and Salmonella Bedford. The Salmonella Bedford data set used is unusual and perhaps unique in that it provides information where more than 50% of the population survival has been measured. These measurements are often overlooked or missed in experimental work but are essential when using a vitalistic approach, enabling calculation of a 50% lethal dose for destruction of bacteria. Use of the normal or Prentice distribution provided better fits to the data than other models commonly used to describe thermal death. There was no obvious bias in the fits even though significant tailing was evident. In addition, the procedure described allows data from all the conditions to be fitted rather than individual independent series. This enables a single equation to be derived that can be judged against the whole domain of the data. Approaches that provide accurate and unbiased descriptions of thermal death are likely to become increasingly important to ensure the safety of more marginal heat processes.

Clostridium botulinum↗

PubMed2005

[Roles of reader's feelings in understanding narratives: forefeel, empathy, and a sense of strangeness].

This study examined the cross-domain, anticipatory, and self-referential roles of affect (Miall, 1989) in reading short mystery novels. In Experiment 1, undergraduate students either read an entire story once or read the same story twice. During the first reading, these participants read only the first part of the story, and during the second reading, they read the entire story. They rated the importance of each sentence. Then they either described a prediction or their impression of the story. Finally, they created a title. In Experiment 2, the first group rated the importance of each sentence. The second group rated the feelings of understanding: forefeel, empathy, and a sense of strangeness. The results of both experiments showed that the relative importance of sentences shifted between first reading and second reading. As they read the end of the story, empathy increased but a sense of strangeness decreased. The results of description showed that the readers updated their interpretations in order to understand the story correctly.

Adult↗

PubMed1993

[Charcot and claudicatio intermittens - a footnote to the history of vascular surgery].

Jean Martin Charcot was the first to give a detailed description of intermittent claudication, and a correct interpretation of the mechanism behind the symptoms. He borrowed the name of the syndrome from the veterinarian literature, where it had been described to occur in horses, and caused by inflammatory changes in aorta at the origin of the large vessels to the extremities. The case presented by Charcot was a man with a traumatic pseudoaneurysm in his common iliac artery. He had in addition an arterio-enteric fistula, a condition which probably had not been described before.

France↗

PubMed2002

Infant mortality statistics from the 2000 period linked birth/infant death data set.

OBJECTIVES: This report presents the 2000 period infant mortality statistics from the linked birth/infant death data set (linked file) by a variety of maternal and infant characteristics. METHODS: Descriptive tabulations of data are presented and interpreted. RESULTS: Infant mortality rates ranged from 3.5 per 1,000 live births for Chinese mothers to 13.5 for black mothers. Among Hispanics, rates ranged from 4.5 for Cuban mothers to 8.2 for Puerto Rican mothers. Infant mortality rates were higher for those infants whose mothers had no prenatal care, were teenagers, had 9-11 years of education, were unmarried, or smoked during pregnancy. Infant mortality was also higher for male infants, multiple births, and infants born preterm or at low birthweight. The three leading causes of infant death--Congenital malformations, low birthweight, and Sudden infant death syndrome (SIDS)--taken together accounted for 45 percent of all infant deaths in the United States in 2000. Cause-specific mortality rates varied considerably by race and Hispanic origin. For infants of black mothers, the infant mortality rate for low birthweight was nearly four times that for white mothers. For infants of black and American Indian mothers, the SIDS rates were 2.4 and 2.3 times that for non-Hispanic white mothers.

Birth Weight↗

PubMed2003

Natural killer resistance of a drug-resistant leukemia cell line, mediated by up-regulation of HLA class I expression.

BACKGROUND AND OBJECTIVES: Drug-resistant leukemia cells may exhibit cross-resistance towards immunological effector mechanisms by alterations of apoptosis pathways. This is particularly relevant in allogeneic bone marrow transplantation for leukemia, where the graft-versus-leukemia effect acts on cells pretreated with cytostatic drugs. Here, we clarify the mechanism underlying cross-resistance of drug-resistant variants of the T-leukemia cell line CEM towards natural killer cells. DESIGN AND METHODS: We determined the sensitivity of different CEM sublines to natural killer (NK) cytotoxicity, and separately analyzed the components of the killing machinery by detection of granzyme B-induced caspase cleavage and HLA class I-dependent recognition mechanisms. Furthermore, we studied regulation of HLA class I expression comparing CEM with other cell lines. RESULTS: We found that CEM cells resistant to cytostatic drugs or CD95 were cross-resistant towards NK cells from a variety of donors. Granzyme B-induced caspase and PARP cleavage in the sensitive and resistant cells were comparable, indicating that downstream apoptosis pathways were not altered in the drug-resistant cells. HLA class I molecules were upregulated in the resistant cells, inhibiting NK cells at the level of killer/target recognition. HLA class I upregulation was not found in other leukemia cell lines. INTERPRETATION AND CONCLUSIONS: This is the first description of HLA class I-mediated NK cross-resistance in drug-resistant cells. This finding may have a clinical impact since it may be considered as a possible reason for resistance to a graft-versus-leukemia approach in allogeneic bone marrow transplantation

Antineoplastic Agents↗

PubMed2003

Infant mortality statistics from the 2001 period linked birth/infant death data set.

OBJECTIVES: This report presents 2001 period infant mortality statistics from the linked birth/infant death data set (linked file) by a variety of maternal and infant characteristics. METHODS: Descriptive tabulations of data are presented and interpreted. RESULTS: Infant mortality rates ranged from 3.2 per 1,000 live births for Chinese mothers to 13.3 for black mothers. Among Hispanics, rates ranged from 4.2 for Cuban mothers to 8.5 for Puerto Rican mothers. Infant mortality rates were higher for those infants whose mothers were born in the 50 States and the District of Columbia, were unmarried, or smoked during pregnancy. Infant mortality was also higher for male infants, multiple births, and infants born preterm or at low birthweight. The three leading causes of infant death--Congenital malformations, low birthweight, and Sudden infant death syndrome (SIDS)--taken together accounted for 44 percent of all infant deaths. Cause-specific mortality rates varied considerably by race and Hispanic origin. For infants of black mothers, the cause-specific infant mortality rate for low birthweight was nearly four times that for infants of white mothers. Between 1995 and 2001, the overall infant mortality rate declined by 10.5 percent; significant declines ranged from 8.2 percent for infants of non-Hispanic black mothers to 14.3 percent for infants of Hispanic mothers. The SIDS rate declined by 11 percent from 2000 to 2001. For infants of black and American Indian mothers, the SIDS rates were 2.2 and 2.8 times that for non-Hispanic white mothers.

Adult↗