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PubMedDate not supplied

A new coincidence model for single particle counters, Part I: Theory and experimental verification.

The prerequisites for estimating the effect of signal coincidence on both particle undercounting and the injection of false counts in the implementation of U.S.P. 788 contaminating particle assays by light extinction particle counters are defined. These include a particle concentration measure that varies with particle size and a new model of the counting process. Both prerequisites have been verified empirically: a single normalized equation describes the coincidence effect in all single particle counters. The single parameter of the normalized equation is the number of effective detector volumes per milliliter. A maximum undercount limit of 5% is proposed based on adequately suspended particles. Using the SVP U.S.P. XXII acceptance limits of 10,000 particles per container or the PMA propose 6,000 particles per container maximum for particles > 10 microns in U.S.P. XXIII, undercount errors are estimated for the smallest container sizes. The large concentration of particles below the controlled 10 microns particle size, that has been documented in injectable solutions, can pose an additional 788 measurement hazard. A Poisson model is used to estimate and control the injection of false particle counts into the mandated measurement through particle coincidence. Acceptable counting accuracy limits with present particle counting systems can be achieved by understanding the capabilities of the particle counter measurement system and using a dilution technique when appropriate. The new model of the counting process and the new particle concentration measures can result in standard, conservative, instrument specifications for use in Pharmacopeial contamination testing and in GLP user evaluation tests. Part I of this paper includes the theory of the coincidence effect on particle counting and the particle size distribution measured. A summary of the experimental verification employed to determine coincidence count loss as a function of particle concentration for single particle counters is reported. Part II of this paper describes a practical protocol for the determination of operating limits to achieve a selected coincidence undercount limit for single particle counters.

Drug Contamination↗
PubMed2000

PROFILE: Using GIS to Identify Functionally Significant Wetlands in the Northeastern United States.

/ Of the several automated wetland assessment methods currently available, none are comprehensive in considering all of the primary functions a wetland can perform. We developed a methodology particularly suited to the Northeastern United States that enumerates spatial predictors of wetland function for three primary wetland functions: flood flow alteration, surface water quality improvement, andwildlife habitat. Predictors were derived from several wetland assessment techniques and directly from the literature on wetland structure and function. The methodology was then automated using a Geographic Information System (GIS). The resulting Automated Assessment Method for Northeastern Wetlands (AMNEW) consists of a suite of eight Arc Macro Language (AML) programs that run in the ARC/INFO GRID module. Using remotely sensed land use information and digital elevation models (DEMs), AMNEW produces three separate grids of wetlands that perform each function. The method was tested on four watersheds in Vermont's Lake Champlain Basin. Results and preliminary verification indicate that the method can successfully identify those wetlands in the Northeastern region that have the potential to be functionally important.

Journal Article↗
PubMed2003

Reconsidering the concept of the aided threshold for nonlinear hearing AIDS.

The aided threshold (and functional gain) has been discussed in the context of linear hearing aids since the early 1960s. The use of nonlinear hearing aids, however, could change the meaningfulness of this verification tool because of their unique characteristics. The interpretation of the aided threshold (and functional gain) as it pertains to linear and nonlinear hearing aids is reviewed. Also discussed are the ideas of an optimal aided threshold, factors that may affect its magnitude, and a comparison between functional gain and insertion gain measures. Finally, how to improve the accuracy of the aided thresholds (and functional gain) through the use of in-situ unaided threshold measurements is discussed.

Journal Article↗
PubMed1996

[Diet and drugs in the therapy of nonorganic dyspepsia: the hypothesis and factual data].

Non-organic dyspepsia, although not frequently reported, is still a disorder which is difficult to classify in nosographic and physiopathological terms, a fact which inevitably influences the indications for its treatment. Non-pharmacological treatment of non-organic dyspepsia includes changes in dietary and behavioural habits which, even if established on empirical grounds, play a far from ancillary role. When considered appropriate, pharmacological treatment must be formulated solely on the basis of controlled clinical trials vs placebo given the well-known significance of the placebo effect in this and other so-called "functional" diseases. The therapeutic strategies which are most subject to verification are based on the one hand on the neutralisation or inhibition of gastric acid secretion and, on the other, on the improvement of gastrointestinal motility. Surprisingly, the widely used antacid drugs are among those which have been less well studied and show the lowest efficacy. Among the anti-secretory drugs, pirenzepine is approximately 25% more effective than placebo. H2-antagonists, the drugs which have been most closely studied both in terms of the number of trials and the size of the sample populations studied, produce contradictory results. However, a meta-analysis of the trials shows an overall 18% improvement in efficacy compared to placebo. The overall results of studies on prokinetic compounds are "good" in meta-analytical terms, with an improved efficacy of 50% compared to placebo. This is not necessarily due to the superiority of prokinetic compared to anti-secretory drugs and can be explained by the reduced placebo effect in trials using prokinetic drugs or a greater presence in the latter of dyspepsia which is physiopathologically correlated to motor discord. Among the future drugs still being studied, it is particularly worth mentioning fedotozine, a specific K opioid receptor agonist which appears to have provided extremely interesting results in preliminary studies. The role of barrier drugs, such as sucralfate and colloidal bismuth, continues to remain unclear and in particular the latter might be of increased use if evidence of a relationship between Helicobacter pylori and non-organic dyspepsia were reinforced; this relationship may in fact not exist in all dyspeptic patients but only in a subgroup. Lastly, the problem of the duration of pharmacological treatment still remains unsolved, as do the questions of whether longterm treatment should be conceived once acute symptoms have disappeared and whether it is possible to hypothesise differentiated pharmacological treatment depending on the clinical variants of functional dyspepsia which have been defined with greater attention over the course of the past decade.

Combined Modality Therapy↗
PubMed2001

Perforation of the tympanic membrane and its effect on the real-ear-to-coupler difference acoustic transform function.

It is not always possible to undertake extensive real-ear measurements, especially in infants and young children. An alternative approach is to estimate the real-ear SPL by use of an acoustic transform function such as the real-ear-to-coupler difference (RECD). This may be used to estimate the real-ear sound pressure level (SPL) obtained from an insert transducer or a hearing instrument. The aim of the present study was to investigate the effects of tympanic membrane perforation on the RECD transform function. Subjects in the study comprised two groups of 12 individuals aged between nine and 65 years. One group of subjects had a tympanic membrane perforation and was recruited to the study before admission for myringoplasty. There was no evidence of middle ear pathology in the remaining subjects who comprised the control group. An RECD transform function for an insert transducer was measured on each subject using the standard clinical protocol on the Audioscan RM500 real-ear measurement system. There was a statistically significant difference between the two groups; mean RECD transform value of the perforation group was 9-12 dB lower than the corresponding value in the control group at audiometric frequencies below 1.5 kHz. This difference is probably due to the perforation acting as a vent and allowing low-frequency acoustic energy to escape into the middle ear cavity. Use of an average RECD transform function to estimate real-ear SPL in subjects with a perforation will overestimate the SPL reaching the tympanic membrane. As a result, the derived real-ear SPL obtained by use of either an insert transducer or a hearing instrument will be overestimated. This has implications for the selection and verification of a hearing instrument. The difference in the mean RECD transform function between the control group and subjects with a tympanic membrane perforation supports the use of individually measured RECD values wherever possible.

Acoustic Impedance Tests↗
PubMedDate not supplied

A digital network for long-distance echocardiographic image and data transmission in clinical trials: the CEDIM (Carnitina, Ecocardiografia Digitalizzata, Infarto Miocardico) study experience.

A special computer network has been specifically designed and realized to connect 36 Italian cardiological institutions to a central core laboratory. This network, which has been created to run the CEDIM Multicenter Trial (effects of L-carnitine on left ventricular function in patients with myocardial infarction assessed by digital echocardiography), enables automatic verification, via computer, 24 hours a day, of patient eligibility criteria, randomization, transmission, and filing of real-time left ventricular echocardiographic examinations. All the investigators participating in the CEDIM trial underwent several training courses as well as dummy run procedures to achieve optimal performance of all the operational procedures required for the network to function smoothly and correctly. This paper describes the aims of this special network, its technical characteristics, and the investigator training and dummy run procedures.

Clinical Trials as Topic↗
PubMed2005

Dysprosodic speech following basal ganglia insult: toward a conceptual framework for the study of the cerebral representation of prosody.

Progress in understanding brain/behavior relationships in adult-acquired dysprosody has led to models of cortical hemispheric representation of prosodic processing based on functional (linguistic vs affective) or physical (timing vs pitch) parameters. These explanatory perspectives have not been reconciled, and also a number of neurobehavior syndromes that include dysprosody among their neurological signs have not yet been integrated. In addition to expanding the functional perspective on prosody, some of these syndromes have implicated a significant role of subcortical nuclei in prosodic competence. In this article, two patients with acquired dysprosodic speech following damage to basal ganglia nuclei were evaluated using behavioral, acoustic, cognitive, and radiographic approaches. Selective quantitative measures were performed on each individual's performance to provide detailed verification and clarification of clinical observations, and to test hypotheses regarding prosodic function. These studies, combined with a review of related clinical research findings, exemplify the value of a broader perspective on the neurobehavioral dysfunction underlying acquired adult dysprosodic speech, and lead to a new, proposed conceptual framework for the cerebral representation of prosody.

Adult↗
PubMed2002

Theory of liquid chromatography of mono- and difunctional macromolecules. I. Studies in the critical interaction mode.

The theory of liquid chromatography of mono- and difunctional polymers based on the model of ideal polymer chain in wide slit-like pores is presented. Analytical equations describing chromatographic behavior of functional macromolecules in both adsorption, exclusion and critical modes are derived and compared with experiments. The focus of this experimental study was on the verification of the theory in chromatography at critical conditions. Chromatographic behavior of low molar mass end-functionalized polyethylene glycols was found to be in a very good qualitative and in a reasonable quantitative agreement with the theory.

Chromatography, Liquid↗
PubMed1997

[First comparisons with laser vibrometry measurements and computer simulation of ear ossicle movements].

The dynamic behavior of the ossicular chain is very complex and is frequency-dependent. To date, this has still not been fully investigated or understood. There remains a lack of measurement procedures to pick up the motion of the ossicles and ear drum simultaneously with sufficient resolution. The presented paper reports simultaneous measurements with laser-Doppler vibrometry at two points of the ossicular chain of cadaver specimens. Motions not observed were derived using mechanical simulation models on a computer and then evaluating appropriate mathematical equations. Using a sound stimulus, the displacement velocities of the umbo and stapes footplate were measured, and the corresponding transfer functions were derived by Fourier transform. Results were used for verification of the computer models. In the current investigations these models were refined and allow for the detailed investigation of the dynamic behavior of the ossicular chain, facilitating the optimal design of passive and active middle-ear implants.

Computer Simulation↗
PubMed1992

Results of the ESA study on psychological selection of astronaut applicants for Columbus Missions I: aptitude testing.

European participation in the Space Station Freedom brought about new challenges for the psychological selection of astronaut candidates, particularly in respect to specific demands of long duration space flights. For this reason existing selection criteria and methods were reassessed. On these grounds a study was undertaken applying a unique composition of aptitude tests to a group of 97 ESA scientists and engineers who are highly comparable to the expected astronaut applicants with respect to age and education. The tests assessed operational aptitudes such as logical reasoning, memory function, perception, spatial orientation, attention, psychomotor function, and multiple task capacity. The study goals were: 1) Verification of psychometric qualities and applicability of tests in a normative group; 2) Search for culture-fair tests by which multi-national groups can be examined; 3) Identification of test methods which consider general and special operational demands of long duration space flights. Based on the empirical findings a test battery was arranged for use in the selection of ESA astronaut applicants. Results showed that 16 out of the 18 employed tests have good psychometric qualities and differentiate reliably in the special group of testees. The meta structure of the test battery as described by a factorial analysis is presented. Applicability of tests was generally high. Tests were culture-fair, however, a relation between English language skills and test results was identified. Since most item material was language-free, this was explained with the importance of English language skills for the understanding of test instructions. Solutions to this effect are suggested.

Adult↗
PubMed2005

Molecular basis of the effects of shear stress on vascular endothelial cells.

Blood vessels are constantly exposed to hemodynamic forces in the form of cyclic stretch and shear stress due to the pulsatile nature of blood pressure and flow. Endothelial cells (ECs) are subjected to the shear stress resulting from blood flow and are able to convert mechanical stimuli into intracellular signals that affect cellular functions, e.g., proliferation, apoptosis, migration, permeability, and remodeling, as well as gene expression. The ECs use multiple sensing mechanisms to detect changes in mechanical forces, leading to the activation of signaling networks. The cytoskeleton provides a structural framework for the EC to transmit mechanical forces between its luminal, abluminal and junctional surfaces and its interior, including the cytoplasm, the nucleus, and focal adhesion sites. Endothelial cells also respond differently to different modes of shear forces, e.g., laminar, disturbed, or oscillatory flows. In vitro studies on cultured ECs in flow channels have been conducted to investigate the molecular mechanisms by which cells convert the mechanical input into biochemical events, which eventually lead to functional responses. The knowledge gained on mechano-transduction, with verifications under in vivo conditions, will advance our understanding of the physiological and pathological processes in vascular remodeling and adaptation in health and disease.

Endothelial Cells↗
PubMed2000

RNA differential display of scarless wound healing in fetal rabbit indicates downregulation of a CCT chaperonin subunit and upregulation of a glycophorin-like gene transcript.

BACKGROUND/PURPOSE: Scars form as wounds heal in adult organisms. In addition to disrupting cosmetic appearance, scar tissue can cause significant morbidity, and even death if it blocks vital organ function. Previous work has established that fetal wounds, especially in early to midgestation, can heal without scarring. Because such inherent physiological mechanisms ultimately are under genetic control, a study was initiated to elucidate the differences in gene expression that produce scarless wound healing in the mammalian fetus but scarring in postnatal wounds. Reverse transcription polymerase chain reaction (RT-PCR) differential display (DD) was used to detect differentially expressed mRNA transcripts in a rabbit model of wound healing. METHODS: Adult and 21-day fetal full-thickness rabbit skin specimens from wounded and unwounded sites were harvested 12 hours postwounding. RNA extracted from the tissue was used as a template in DD reactions using anchoring and random primers to generate tissue-specific gene expression fingerprints. The over 2,000 resulting amplimers (gene transcripts) were screened for differential expression among the 4 types of specimens: fetal control (unwounded), fetal wound, adult control, and adult wound. Selected bands distinctly upregulated or downregulated in fetal wound lanes on the DD gels were excised, and the cDNA was extracted, reamplified, cloned into vectors, and sequenced. DD results were confirmed by limiting-dilution RT-PCR using sequence-specific primers. RESULTS: Differential display (DD) showed 22 amplimers that were significantly upregulated in all fetal wound samples as compared with little or no expression in fetal control, adult control, or adult wound tissues. Conversely, 5 transcripts were downregulated in the fetal wound specimens but highly expressed in the 3 comparison tissues. Reamplification of selected transcripts by PCR, followed by cloning and DNA sequencing, yielded 7 distinct sequences, each representing a gene expressed differently in fetal wound than in the other 3 tissues. A transcript that was downregulated in fetal wound showed very high sequence homology to part of the human gene for the eta subunit of the hetero-oligomeric particle CCT (the chaperonin containing T-complex polypeptide 1 or TCP-1). An upregulated amplimer showed significant DNA sequence homology to glycophorins A and B. One sequence was identified as 28S rRNA. The remaining 4 candidate sequences showed no significant homology to known genes, but 1 had high homology to expressed sequence tags of unknown function. CONCLUSIONS: With careful experimental design and proper controls and verifications, differential display of RNA expression is a potentially powerful method of finding genes that specifically regulate a particular physiological process such as fetal wound healing. No a priori knowledge of what genes might be involved, or why, is necessary. This study indicates that downregulation of a gene that codes for a chaperonin subunit and upregulation of several other genes may be involved in the striking scarless character of wound healing in the mammalian fetus. Results suggest the hypothesis that downregulation of the CCT chaperonin in fetal wound may inhibit the formation of myofibroblasts, a cell type that correlates highly with scarring in postnatal wound healing, by preventing the folding of sufficient alpha-smooth muscle actin to form the stress fibers characteristic of these cells.

Amino Acid Sequence↗
PubMed1991

Graded stress radiography of injured anterior cruciate ligaments.

Fifty-five patients with clinical suspicion of injury to their anterior cruciate ligament (ACL) were examined by graded stress radiography before arthroscopic verification in an effort to determine the loss of ACL function as a result of ligament tearing. Using a commercially available stress device capable of applying varying pressures to the mid-calf, anterior drawers were measured from lateral radiographs at 0-, 7-, 14-, and 21-kiloPascal pressures and used to calculate the equivalent elastic modulus of the remaining ACL fibers. According to viscoelastic theory, this modulus is proportional to the number of elastically active fibers in the ligament. To verify the validity of this concept, the stress-strain relationship of a freshly excised ACL ligament was examined in a tensile testing machine, and the procedure was repeated after the ligament had been partially transsected with a scalpel. Comparison with the elastic modulus of the (intact) ACL of the opposite knee permits an estimate of the percentage of rupture in cases of partial tears. Overstretched ligaments show essentially normal viscoelastic properties once the slack in the ligament has been taken up. Complete tears, on the other hand, show a complete breakdown in the viscoelastic properties of the ACL. The results show that partial tears can be diagnosed by graded stress radiography with a sensitivity of 20% and specificity of 90%. Diagnosis of overstretched ligaments had sensitivity of 50% and specificity of 94%. Complete tears were detected with sensitivity of 88% and specificity of 75% as diagnosed against all other ACL lesions and including normals.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed2000

Identification of the pseudorabies virus promoter required for latency-associated transcript gene expression in the natural host.

Expression of the latency-associated transcript (LAT) gene is a hallmark of alphaherpesvirus latency, and yet its control and function remain an enigma. Resolution of this problem will require verification and subsequent elimination or disabling of elements regulating LAT gene transcription so that the influence of the resultant RNA can be evaluated. Toward this end, we generated a novel pseudorabies virus (PrV) recombinant in which a 282-bp region containing the LAP1 (first latency-active promoter) consensus sequence was replaced by a reporter cassette. Despite this substitution, replication of the recombinant was comparable to that of the parental and rescuant viruses both in cultured mammalian cells and in the natural host, swine. Furthermore, production of the LAT gene-associated 2.0- and 8.0-kb RNAs during an in vitro lytic infection of cultured neuronal cells was unaffected. However, the otherwise constitutively produced and processed 8.4-kb LAT was not detected in porcine trigeminal ganglia latently infected with this novel recombinant, although the viral genome was shown to be present. Therefore, LAP1 is apparently the basal promoter for PrV LAT gene expression during viral latency but is not required for such activity during an in vitro lytic infection of neuronal cells. More importantly, the ability of PrV to persist in a latent state in the absence of LAT suggests that other factors are responsible for this event in the natural host.

Animals↗
PubMed1986

Ketoconazole-induced stimulation of gonadotropin output in men: basis for a potential test of gonadotropin reserve.

The antifungal drug ketoconazole is known to inhibit testosterone biosynthesis and decrease serum testosterone concentrations. To assess whether the ketoconazole-induced reduction in serum testosterone might stimulate LH and FSH output in a manner suitable as a test of pituitary gonadotropin reserve, we gave normal men ketoconazole every 8 h for 1 week in dosages of 300-1200 mg/day. Ketoconazole administration caused a dose-dependent reduction in serum testosterone which correlated inversely with serum ketoconazole (r = -0.82; P less than 0.001). This fall in serum testosterone stimulated increases in serum LH and FSH which were maximal at a ketoconazole dose of 900 mg/day [LH increase, 127 +/- 27% (+/- SEM); FSH increase, 63 +/- 15%]. Ketoconazole tended to blunt the LH and FSH responses to LHRH. Ketoconazole increased serum 17-hydroxyprogesterone, reflecting blockade of 17,20-desmolase by the drug, while having inconsistent effects on serum estradiol. I conclude that ketoconazole administration for 1 week to normal men stimulates LH and FSH output in a fashion that makes it potentially suitable, after additional verification in subjects with normal and abnormal pituitary-testicular function, as a test of pituitary gonadotropin reserve.

17-alpha-Hydroxyprogesterone↗
PubMed1978

[Somatosensory evoked cortical potentials (SSEP) in regenerating nerves following suture (author's transl)].

In 37 patients with sutured median and ulnar nerves 106 SSEP were evaluated. Stimulation of the finger nerves was performed at a rate of 4-6/sec. In the early stage of reinnervation, just when the electrical stimulus was perceived, the second positive component (P2) of the SSEP could be recorded, but the primary part of the SEP (N1/P1) was highly reduced or absent. At this time no peripheral nerve action potential or muscle action potential could be obtained. In a follow-up study the sensory regenerating process expressed in a clinical sensibility index (S1-S4+), corresponded well with latency and amplitude of the primary potential of the SSEP: N1-latency decrease and N1/P1 and especially P2/N3-amplitude increase corresponded with improving sensibility. The abnormally high P2-wave is assumed to be an expression of central adaptation and reintegration. The method seems to be of diagnostic value as a test of peripheral nerve function especially in early and late stages of reinnervation, in verification of collateral reinnervation and in objectifying sensory defects in forensic cases.

Follow-Up Studies↗
PubMed1990

[Early orthodontic treatment].

Early orthodontic treatment has recently become a subject of great interest among orthodontists since it is the result of the closest approach between the American and the European orthodontic trends. The early orthodontic treatment emerged from the better knowledge and deeper study of the philosophy of the functional, orthopedic and removable appliances as well as from the verification of their effectiveness, especially during childhood. An analysis of the term "Early orthodontic treatment" is being done in this study in contrast to the term "Early orthodontic management". Timing of orthodontic management of dentofacial deformities is quoted. The main points of a successful early orthodontic treatment as well as advantages and disadvantages, positive and negative criteria of it are mentioned.

Age Factors↗
PubMed1987

[Program of scientific research in the field of occupational medicine 1986-1990].

Changes in the system of research planning and co-ordination in Poland promoted the development of centrally supervised programs with preferences in financial terms. Of 100 centrally supervised programs, four are related to medical sciences, in this one--to occupational health. The research program, accepted after a profound discussion, has been mainly directed towards: progress in reliable evaluations of work environment in national economy; establishment of interrelationships between work conditions and workers' health in many industrial branches; and development and enforcement of effective preventive measures. Priority is given to the following research trends, the results of which may significantly affect the efficiency of health- and preventive care rendered to workers: development and control of new methods for early diagnosis of health lesions prior to clinical pathology and prior to the occurrence of work disablement, whether temporary or durable; development and enforcement of methods allowing to single out workers susceptible to the effects of particular environmental hazards with the aim of avoiding unforeseeable health effects of occupational exposure. determination and verification of conditions promoting the effectiveness of the primary health care for workers covered by the industrial health service. development and verification, under model conditions, of the principles of organizing and functioning of the primary health care, especially preventive care, for workers of small plants which hitherto have not been covered by the industrial health service. development of a more effective--than the hitherto functioning--system of rehabilitation for disabled people, especially occupational rehabilitation being accomplished at special workplaces. A detailed list of goals planned to be achieved up till 1990 has been attached to the complete version of the paper.

Health Services Research↗