bluuebunny/crossref_metadata_2025_split huggingface dataset:
The Development and Practice of Social Dentistry in Germany
Authors: Nippert R. Peter 
Published: April 2007

AbstractThe traditions of social dentistry in Germany represent early forms of dental public health development. It was promoted in dental care facilities where salaried dentists delivered services to target groups, i.e., schoolchildren and sickness fund members. They enabled larger numbers of patients to receive dental care, especially those of lower class origin who otherwise would have remained untreated because of lack of financial resources or scar‐city of manpower. School dental clinics not only delivered dental treatment, but also distributed oral hygiene and nutritional information to school‐aged children. Social dentistry in the prefluoride era in Germany pursued an egalitarian and social‐class oriented concept of dental care delivery, aiming at compensating the detrimental effects that the private practice‐based, fee‐for‐service financed dental care system had produced in the lower classes of the population. The impact of the Nazi regime nearly abolished the institutions of social dentistry. They never were restored in West Germany after World War II. In East Germany dental care had been organized according to traditions of social dentistry, i.e., delivering services in dental treatment centers. Since the unification of the two German states, the institutions of dental care delivery in former East Germany have been restructured to fit the private practice‐based model of former West Germany, eliminating most of the social dentistry institutions in the country.
Dentists, Drugs, and Decisions: Introduction to Part I‐Therapeutic Drugs
Authors: Kula Katherine 
Published: April 2007

AbstractNumerous dental therapeutic agents or drugs are available over the counter or with prescription for patient use at home or in a professional office. Knowledge of the processes by which these agents are evaluated for safety and efficacy by the FDA and ADA is necessary for dental professionals to make intelligent decisions concerning their use. Several examples of problems with drug/cosmetic evaluations are cited.
FDA's New Drug Evaluation Process: a General Overview
Authors: Walters Philip G. 
Published: April 2007

AbstractA 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.
ADA Dental Product Evaluation: Case History
Authors: Barnett Michsael L. 
Published: April 2007

AbstractThe ADA Acceptance Programs entail a rigorous evaluation of products and offer clear benefits to manufacturers, dental professionals, and consumers alike. This paper outlines the implications of the ADA product‐evaluation programs for each of these three constituencies and concludes that while there may be an occasional downside from the manufacturer's standpoint, their net effect is to provide assurances that products are safe, efficacious, and promoted properly.
How the FDA and the ADA Affect Development of Prescription Drugs for Oral Care
Authors: Cooley William E. 
Published: April 2007

AbstractThe patient‐consumer, the health professional, and the producer are all essential in the world of prescription drugs for oral care. Also essential are the Food and Drug Administration (FDA) and the American Dental Association (ADA). The FDA is charged with reviewing new‐drug applications in the United States and approving those drugs that are proved safe and effective. The FDA also controls prescription‐drug advertising and promotion. The ADA applies professional standards in judging all submitted dental drugs. Those drugs accepted by ADA's Council on Dental Therapeutics may display the ADA seal in labeling and advertising. All advertising for accepted products must be cleared by the ADA. An example of a prescription drug approved by the FDA and accepted by the ADA is 0.12 percent chlorhexidine gluconate oral rinse (Peridex). This drug followed the FDA's investigational‐drug (IND) regulations before final approval as a treatment for gingivitis.
Statistical vs Clinical Significance in Product Testing: Can They Be Designed to Satisfy Equivalence?
Authors: Kingman Albert 
Published: April 2007

AbstractStatistical issues associated with demonstrating significance between treatment groups (efficacy or superiority) and nonsignificance (equivalence) are presented and discussed. Methodologies for demonstrating efficacy of a product are proposed and contrasted, incorporating clinical and statistical criteria, with emphasis on situations in which placebo groups are precluded from the study design. Distinctions are drawn between study designs for demonstrating superiority and those for equivalence, including the determination of sample sizes needed for the different approaches. The “at least as good as” criterion is proposed as a reasonable alternative to that of equivalence in active control equivalence studies for demonstrating that dental product modifications or new products are efficacious.
Effect of Regulatory and Professional Guidelines on the Development and Marketing of a Dental Device: Case History
Authors: Ross Candy B. 
Published: April 2007

AbstractThe FDA encourages organizations such as the ADA to develop voluntary standards for drugs and dental devices. The landmark process of gaining ADA approval of an oral irrigator as the first therapeutic device is described. The process was time consuming and expensive, and obligates the manufacturer to submit all future marketing and advertising claims for ADA review. The ADA should continue to ensure standardized guidelines for all product categories. Education of the dental profession and the consumer concerning the significance of the ADA seal of approval is encouraged.
The View and Responsibility of the Advertising Agency Toward Advertising Claims
Authors: Sweeney Thomas M. 
Published: April 2007

AbstractHealth care advertising agencies must create communication that is simultaneously creative, scientifically accurate, relevant, within fair balance, simple, motivating, within approved labeling, and approvable by the client, the dental profession, and regulatory bodies. The advertising must also stimulate sales of the product being advertised. Subjective decisions concerning these requirements place the agency and its client at risk for financial losses and embarrassment.
Legal Implications of Using Drugs and Devices in the Dental Office
Authors: Wakeen Linda M. 
Published: April 2007

AbstractChoosing dental products that are FDA and/or ADA approved is a wise choice concerning their safety and efficacy for approved uses. However, the dentist must show that the product was indicated by a particular patient's needs. Uses of approved dental products in nonapproved ways or use of nonapproved products may be considered as negligence in some malpractice actions, but allowed under standards of reasonableness in other situations. The dentist must be able to justify decisions on a scientific basis. Legal ramifications of various decisions made in the context of difficult prescription choices are discussed.
A qualitative study of institutional review board members’ experience reviewing research proposals using emergency exception from informed consent
Authors: McClure Katie B , Delorio Nicole M , Schmidt Terri A , Chiodo Gary , Gorman Paul 
Published: April 2007

Background:Emergency exception to informed consent regulation was introduced to provide a venue to perform research on subjects in emergency situations before obtaining informed consent. For a study to proceed, institutional review boards (IRBs) need to determine if the regulations have been met.Aim:To determine IRB members’ experience reviewing research protocols using emergency exception to informed consent.Methods:This qualitative research used semistructured telephone interviews of 10 selected IRB members from around the US in the fall of 2003. IRB members were chosen as little is known about their views of exception to consent, and part of their mandate is the protection of human subjects in research. Interview questions focused on the length of review process, ethical and legal considerations, training provided to IRB members on the regulations, and experience using community consultation and notification. Content analysis was performed on the transcripts of interviews. To ensure validity, data analysis was performed by individuals with varying backgrounds: three emergency physicians, an IRB member and a layperson.Results:Respondents noted that: (1) emergency exception to informed consent studies require lengthy review; (2) community consultation and notification regulations are vague and hard to implement; (3) current regulations, if applied correctly, protect human subjects; (4) legal counsel is an important aspect of reviewing exception to informed-consent protocols; and (5) IRB members have had little or no formal training in these regulations, but are able to access materials needed to review such protocols.Conclusions:This preliminary study suggests that IRB members find emergency exception to informed consent studies take longer to review than other protocols, and that community consultation and community notification are the most difficult aspect of the regulations with which to comply but that they adequately protect human subjects.
Characteristics of deaths occurring in hospitalised children: changing trends
Authors: Ramnarayan Padmanabhan , Craig Finella , Petros Andy , Pierce Christine 
Published: April 2007

Background:Despite a gradual shift in the focus of medical care among terminally ill patients to a palliative model, studies suggest that many children with life-limiting chronic illnesses continue to die in hospital after prolonged periods of inpatient admission and mechanical ventilation.Objectives:To (1) examine the characteristics and location of death among hospitalised children, (2) investigate yearwise trends in these characteristics and (3) test the hypothesis that professional ethical guidance from the UK Royal College of Paediatrics and Child Health (1997) would lead to significant changes in the characteristics of death among hospitalised children.Methods:Routine administrative data from one large tertiary-level UK children’s hospital was examined over a 7-year period (1997–2004) for children aged 0–18 years. Demographic details, location of deaths, source of admission (within hospital vs external), length of stay and final diagnoses (International Classification of Diseases-10 codes) were studied. Statistical significance was tested by the Kruskal–Wallis analysis of ranks and median test (non-parametric variables), χ2test (proportions) and Cochran–Armitage test (linear trends).Results:Of the 1127 deaths occurring in hospital over the 7-year period, the majority (57.7%) were among infants. The main diagnoses at death included congenital malformations (22.2%), perinatal diseases (18.1%), cardiovascular disorders (14.9%) and neoplasms (12.4%). Most deaths occurred in an intensive care unit (ICU) environment (85.7%), with a significant increase over the years (80.1% in 1997 to 90.6% in 2004). There was a clear increase in the proportion of admissions from in-hospital among the ICU cohort (14.8% in 1998 to 24.8% in 2004). Infants with congenital malformations and perinatal conditions were more likely to die in an ICU (OR 2.42, 95% CI 1.65 to 3.55), and older children with malignancy outside the ICU (OR 6.5, 95% CI 4.4 to 9.6). Children stayed for a median of 13 days (interquartile range 4.0–23.25 days) on a hospital ward before being admitted to an ICU where they died.Conclusions:A greater proportion of hospitalised children are dying in an ICU environment. Our experience indicates that professional ethical guidance by itself may be inadequate in reversing the trends observed in this study.
Distribution of late instar Lymantria dispar cadavers killed by Entomophaga maimaiga on trunks of several tree species in southwestern Japan
Authors: Jikumaru Shota , Sano Toshikazu 
Published: April 2007

Attachment of late-instar Lymantria dispar L. (Lepidoptera: Lymantriidae) cadavers killed by Entomophaga maimaiga Humber, Shimazu et Soper (Zygomycetes: Entomophthorales) on trunks of five dominant tree species was determined in a broadleaf forest in southwestern Japan. The highest numbers of cadavers were found attached to the trunk of Pasania glabra (Thunb.) Oerst., while there were moderate numbers of cadavers on the trunks of Quercus glauca Thunb. and Quercus serrata Thunb. and no cadavers were found attached to trunks of Ilex pedunculosa Miq. and Clethra barbinervis Sieb. et Zucc.. All examined cadavers contained E. maimaiga resting spores. The differences in cadaver attachment among tree species may influence density of E. maimaiga resting spores around tree bases, which act as reservoirs for fungal survival during unfavorable periods or over numerous years. Our results provide important information as to where to collect E. maimaiga resting spores for biological control of L. dispar, especially in forests containing many tree species.
The cooler side of mycorrhizas: their occurrence and functioning at low temperatures
Authors: Tibbett Mark , Cairney John W.G. 
Published: April 2007

Mycorrhizal associations occur in a range of habitats in which soils are subject to low temperature (≤15 °C) for a significant part of the year. Despite this, most of our understanding of mycorrhizal fungi and their interactions with their plant hosts is based on physiological investigations conducted in the range 20–37 °C using fungi of temperate origin. Comparatively little consideration has been given to the cold edaphic conditions in which many mycorrhizas survive and prosper, and the physiological and ecological consequences of their low temperature environments. In this review, we consider the distribution and persistence of arbuscular and ectomycorrhizal mycorrhizal associations in cold environments and highlight progress in understanding adaptations to freezing resistance and nutrient acquisition at low temperature in mycorrhizal fungi.
Light- and electron-microscopic observations of Cladosporium sp. growing on basidia of Exobasidum camelliae var. gracilis
Authors: Mims C.W. , Hanlin R.T. , Richardson E.A. 
Published: April 2007

Basidia of the plant-pathogenic fungus Exobasidium camelliae var. gracilis Shirai became exposed on the abaxial side of an infected leaf of Camellia sasanqua Thunb. following the sloughing of the undersurface of the leaf. Basidia were formed in tremendous numbers in a distinct hymenium that appeared as a white, felt-like layer. Subsequently, colonies of another fungus, Cladosporium sp. appeared, initially as tiny dark dots on this white layer, but quickly increased in size to form larger circular colonies that were olive-brown to dark brown in color. Adjacent colonies sometimes merged to form larger growths with irregular margins that often covered much of the hymenium on the underside of an E. camelliae-infected leaf. The hyphae that made up a young Cladosporium sp. colony were primarily confined to the surface of the E. camelliae hymenium, and we found no evidence that hyphae actually penetrated living basidia. However, E. camelliae basidia overrun by Cladosporium sp. eventually showed signs of necrosis and finally collapsed and died, creating a slightly sunken area in the hymenium. Hyphae of Cladosporium sp. grew throughout the remains of the dead basidia, but did not appear to spread into the leaf tissue above the pseudoparenchymatous layer of hyphae that gave rise to the basidia. Based upon our observations, it is clear that Cladosporium sp. is a necrotrophic mycoparasite. More specifically, it qualifies as a contact necrotrophic, since it kills basidia without first penetrating them with its hyphae.
Genomic analysis of human lung fibroblasts exposed to vanadium pentoxide to identify candidate genes for occupational bronchitis
Authors: Ingram Jennifer L , Antao-Menezes Aurita , Turpin Elizabeth A , Wallace Duncan G , Mangum James B , Pluta Linda J , Thomas Russell S , Bonner James C 
Published: April 2007

Abstract

Background
Exposure to vanadium pentoxide (V2O5) is a cause of occupational bronchitis. We evaluated gene expression profiles in cultured human lung fibroblasts exposed to V2O5
in vitro in order to identify candidate genes that could play a role in inflammation, fibrosis, and repair during the pathogenesis of V2O5-induced bronchitis.

Methods
Normal human lung fibroblasts were exposed to V2O5 in a time course experiment. Gene expression was measured at various time points over a 24 hr period using the Affymetrix Human Genome U133A 2.0 Array. Selected genes that were significantly changed in the microarray experiment were validated by RT-PCR.

Results
V2O5 altered more than 1,400 genes, of which ~300 were induced while >1,100 genes were suppressed. Gene ontology categories (GO) categories unique to induced genes included inflammatory response and immune response, while GO catogories unique to suppressed genes included ubiquitin cycle and cell cycle. A dozen genes were validated by RT-PCR, including growth factors (HBEGF, VEGF, CTGF), chemokines (IL8, CXCL9, CXCL10), oxidative stress response genes (SOD2, PIPOX, OXR1), and DNA-binding proteins (GAS1, STAT1).

Conclusion
Our study identified a variety of genes that could play pivotal roles in inflammation, fibrosis and repair during V2O5-induced bronchitis. The induction of genes that mediate inflammation and immune responses, as well as suppression of genes involved in growth arrest appear to be important to the lung fibrotic reaction to V2O5.
Continuous in situ measurements of volcanic gases with a diode-laser-based spectrometer: CO2 and H2O concentration and soil degassing at Vulcano (Aeolian islands: Italy)
Authors: De Rosa Maurizio , Gagliardi Gianluca , Rocco Alessandra , Somma Renato , De Natale Paolo , De Natale Giuseppe 
Published: April 2007

AbstractWe report on a continuous-measurement campaign carried out in Vulcano (Aeolian islands, Sicily), devoted to the simultaneous monitoring of CO2 and H2O concentrations. The measurements were performed with an absorption spectrometer based on a semiconductor laser source emitting around a 2-μm wavelength. The emitted radiation was selectively absorbed by two molecular ro-vibrational transitions specific of the investigated species. Data for CO2 and H2O concentrations, and CO2 soil diffusive flux using an accumulation chamber configuration, were collected at several interesting sampling points on the island (Porto Levante beach- PLB, Fossa Grande Crater – FOG- and Valley of Palizzi, PAL). CO2/H2O values, measured on the ground, are very similar (around 0.019 (± 0.006)) and comparable to the previous discrete detected values of 0.213 (Fumarole F5-La Fossa crater rim) and 0.012 (Fumarole VFS – Baia Levante beach) obtaid during the 1977–1993 heating phase of the crater fumaroles.In this work much more homogeneous values are found in different points of the three sites investigated. The field work, although carried out in a limited time window (25th–28th August 2004), pointed out the new apparatus is suitable for continuous gas monitoring of the two species and their ratios, which are important geochemical indicators of volcanic activity, for which other reliable continuous monitoring systems are not yet available.
Selective prediction of interaction sites in protein structures with THEMATICS
Authors: Wei Ying , Ko Jaeju , Murga Leonel F , Ondrechen Mary Jo 
Published: April 2007

Abstract

Background
Methods are now available for the prediction of interaction sites in protein 3D structures. While many of these methods report high success rates for site prediction, often these predictions are not very selective and have low precision. Precision in site prediction is addressed using Theoretical Microscopic Titration Curves (THEMATICS), a simple computational method for the identification of active sites in enzymes. Recall and precision are measured and compared with other methods for the prediction of catalytic sites.

Results
Using a test set of 169 enzymes from the original Catalytic Residue Dataset (CatRes) it is shown that THEMATICS can deliver precise, localised site predictions. Furthermore, adjustment of the cut-off criteria can improve the recall rates for catalytic residues with only a small sacrifice in precision. Recall rates for CatRes/CSA annotated catalytic residues are 41.1%, 50.4%, and 54.2% for Z score cut-off values of 1.00, 0.99, and 0.98, respectively. The corresponding precision rates are 19.4%, 17.9%, and 16.4%. The success rate for catalytic sites is higher, with correct or partially correct predictions for 77.5%, 85.8%, and 88.2% of the enzymes in the test set, corresponding to the same respective Z score cut-offs, if only the CatRes annotations are used as the reference set. Incorporation of additional literature annotations into the reference set gives total success rates of 89.9%, 92.9%, and 94.1%, again for corresponding cut-off values of 1.00, 0.99, and 0.98. False positive rates for a 75-protein test set are 1.95%, 2.60%, and 3.12% for Z score cut-offs of 1.00, 0.99, and 0.98, respectively.

Conclusion
With a preferred cut-off value of 0.99, THEMATICS achieves a high success rate of interaction site prediction, about 86% correct or partially correct using CatRes/CSA annotations only and about 93% with an expanded reference set. Success rates for catalytic residue prediction are similar to those of other structure-based methods, but with substantially better precision and lower false positive rates. THEMATICS performs well across the spectrum of E.C. classes. The method requires only the structure of the query protein as input. THEMATICS predictions may be obtained via the web from structures in PDB format at: http://pfweb.chem.neu.edu/thematics/submit.html