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PubMed2003

Medical devices; designation of special control for eight surgical suture devices. Final rule.

The Food and Drug Administration (FDA) is issuing a final rule to amend the classification regulations for eight surgical suture devices previously reclassified into class II to specify a special control for those devices. The special control is an FDA guidance document entitled "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA" that identifies performance, testing, and labeling recommendations for the devices. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control. FDA is taking these actions on its own initiative because it believes they are necessary to provide reasonable assurance of the safety and effectiveness of surgical suture devices. These actions are being taken under the Federal Food, Drug, and Cosmetic Act (the act).

Device Approval↗
PubMed2003

[The crude drugs of special location of Sichuan as viewed from the tribute drugs in the Tang dynasty].

As an important location for drug production in history, the tribute drugs from Sichuan in the Tang dynasty occupied a very large quotas. Hence, the study on Sichuan tribute drugs is conducive to the understanding of the distribution of crude drugs of special location and its rules of evolution in different historical periods, with rather significance for the exploration and utilization of crude drugs. There is a rich resource of crude drugs in Sichuan, exhibiting a conspicuous and zone distribution. According to historical documents of the Tang dynasty, the characteristics of the Sichuan tribute drugs include rich species, extensive distribution, rich special and valuable drugs, and processed drugs. There are over 40 kinds of crude drugs of special location produced in Sichuan. The tribute drugs of the Tang dynasty reveal the evolution of crude drugs of special location. Occupying an important position of crude drugs in the whole country, the crude drugs produced in Sichuan are not necessarily to be all tribute drugs.

English Abstract↗
PubMed2003

[Functional specialization of the nuclei in tip-growing coenocytic algae Vaucheria sessilis].

The availability of numerous nuclei in coenocytic thalli creates a problem of their activity and division cycle coordination. An apparent random distribution of nuclei in tip-growing cells is regulated by some principles associated with physiological compartmentalization in the absence of true septae. In vegetative thallome of Vaucheria sessilis the nuclei are distributed equally in proximal parts, to be accumulated in a high density cluster in the apical zone. The cluster appears in the course of germination in the late phase as a result of nuclear migration in a forming branch. The treatment with (methyl-3H)-thymidine and (5-3H)-uridine revealed the functional specialization of nuclei. The most active accumulation of thymidine was observed at early phases of germination in the nuclei of aplanospore. Proportionally with the growth of the new branch, the nuclei migrate into it, and the most active DNA replication zone moves to the filament base. At the late phases of morphogenesis, when the apical cluster of nuclei is available, thymidine accumulation is observed only in the proximal parts of a vegetative branch, rather far from the apical zone. The most active uridine accumulation was registered in the base of a forming filament at early morphogenesis, and in aplanospore at late phases. The apical cluster of nuclei is characterized by a low transcription level and the absence of replication. The obtained results have demonstrated that in the course of morphogenesis the equipotent nuclei acquire some specialization depending on their position in the thallome. The nuclei migrating via the cytoplasm toward the basal part of a filament are able to divide and actively transcript their own genome. The nuclei in the aplanospore at early phases of germination may predominantly realize the division cycle. The nuclei in the apical cluster, with a special organization of the cytoskeleton net, lose their ability to divide and migrate, and lack the ability to transcript a proper genome. The space delimination of the growth zone and a zone of division, as well as a functional specialization of nuclei can be considered as some basic characters of the apical growth.

Cell Division↗
PubMed2004

Perinatal mortality in the Special Care Nursery of Moi Teaching and Referral Hospital, Eldoret, Kenya.

OBJECTIVES: To determine the mortality rate and causes of death of all infants admitted to the Special Care Nursery (SCN) of a tertiary referral hospital in rural Kenya. DESIGN: Prospective and Cross-sectional study SETTING: Special Care Nursery, Moi Teaching and Referral Hospital, Eldoret, Kenya. SUBJECTS: All infants admitted to the Special Care Nursing (SCN). MAIN OUTCOME MEASURES: Survival status at seven postnatal days; major causes of mortality and morbidity. RESULTS: Three hundred and thirty five babies were studied between February and September 1999. Out of these 167 (49.9%) were male. There were 50 (15%) preterm and 124 (37.3%) low birth weight babies. There were 198 (76.2%) appropriate for gestational age (AGA), 46 (17.7%) small for gestational age and 16 (6.2%) large for gestational age babies. The seven day mortality rate of infants admitted to the Special Care Nursery was 66 (19.7%). Birth asphyxia and respiratory distress accounted for most deaths. Infants who were admitted primarily because the mother remained under general anesthesia generally did well. Logistic factors, including inadequate training for neonatal resuscitation in ward cadre of staff, unavailability of trained paediatricians and obstetricians, and inadequate operating theatre supplies were all found to delay treatment and likely to increase mortality. CONCLUSION: Morbidity and mortality of infants born at the MTRH remain high. The most common cause of mortality remains birth asphyxia. Some causative factors, such as lack of resources or personnel, are logistic and could be rectified. Antenatal care had a significant positive impact on both morbidity and mortality.

Cause of Death↗
PubMedDate not supplied

Parental perceptions of oral health-related quality of life for children with special needs: impact of oral rehabilitation under general anesthesia.

PURPOSE: The purposes of this study were to: (1) describe the symptoms, daily life problems and parental concerns related to oral health for children with special health care needs; and (2) examine the effectiveness of oral rehabilitation under general anesthesia at improving quality of life (QOL). METHODS: A single-group design measuring change over time was used. Family caregivers of 107 children with special needs, for whom oral rehabilitation under general anesthesia was recommended, completed a QOL survey upon dental examination. RESULTS: Seventy-three children underwent oral rehabilitation, and 50 completed a follow-up survey. The most frequent survey responses before oral rehabilitation were: (1) spontaneous toothache and pain with hot/cold temperatures (oral symptoms); (2) difficulty eating and sleeping (daily life problems); and (3) worrying about eating and nutrition (parental concerns). Severity ratings for oral symptoms, daily life problems, and parental concerns were significantly lower (P<.001), and scores for oral well-being were significantly higher (P<.001) following oral rehabilitation. CONCLUSIONS: Family caregivers of special health care needs patients report a variety of oral symptoms, daily life problems, and concerns attributable to their child's oral health that impact QOL. Oral rehabilitation under general anesthesia is effective at improving QOL for special health care needs children and their families.

Activities of Daily Living↗
PubMed1992

The Special Forces medic: unique training for a unique mission.

The U.S. Army Special Forces Medic, Military Occupational Specialty 18D, is a unique, enlisted, medical asset. The training of the 18D is demanding, lengthy, and selective. The 18D is trained to independently assess, and provide acute and long-term medical care for, a variety of medical conditions in support of the Special Forces mission. This article briefly discusses the general missions of U.S. Army Special Operations and Special Forces. This is followed by an in-depth discussion of the 55-week selection and training program of the 18D.

Emergency Medical Technicians↗
PubMed2000

New opportunities, new approaches: serving children with special health care needs under SCHIP.

OBJECTIVE: To identify models for caring for children with special health care needs (CSHCN) under the State Children's Health insurance Program (SCHIP) and to analyze the strengths and weaknesses of each. DATA SOURCE: Site visits in five study States conducted in late 1999. STUDY DESIGN: Approximately 12 to 15 interviews were conducted in each site with state and local-level policymakers, program administrators, providers, and families. DATA COLLECTION: Standard protocols were used across sites to explore a range of key policy variables including eligibility, enrollment , identification, and referral of CSHCN; benefits; service delivery systems; payment mechanisms; and quality assurance and monitoring strategies. PRINCIPAL FINDINGS. Each of the study States' approaches to serving CSHCN represents one of four models: a mainstream approach , a wrap-around model, a service carve out , or a specialized system of care. Special provisions designed to enhance the coverage and accessibility of services beyond those extended to children generally can help to ensure that CSHCN enrolled in SCHIP receive comprehensive, coordinated care. CONCLUSIONS: The mainstream approach , wh ile aimed at providing comprehensive care for all children , could not identify CSHCN or monitor their care. Wrap-around models, while offering rich benefits to CSHCN, rely on providers to identify eligible children , with few referrals reported to date. Service carve outs preserve long-standing specialty systems of care for CSH CN but create challenges for care coordination . Specialized systems of care present challenges for capitation but appear to offer the most promise for comprehensive, coordinated care to CSHCN.

Attitude of Health Personnel↗
PubMed2005

New models for improving oral health for people with special needs.

The number of people with special needs is increasing dramatically. In this context, people with special needs refer to people who have difficulty having good oral health or accessing oral health services because of a disability or medical condition. Among these groups, the number of people with developmental disabilities and the emerging population of aging "baby boomers with teeth" are demonstrating dramatic growth. People in these groups have significantly more dental disease than the general population. It is already difficult to impossible for many people with special needs to obtain oral health services. Under the current system of care, this situation will only get worse. The characteristics of a new model, which can better address the oral health problems of people with special needs, are described.

Delivery of Health Care↗
PubMed2005

The Minnesota Oral Health Care Solutions Project: implications for people with special needs.

Disparities in oral health status and access to dental care are major problems for people with special needs in Minnesota and across the country. The current delivery system for people with special needs is failing. Patients, community leaders, private dentists, safety net clinics, and state agencies are frustrated with the Medicaid program that funds the current system; and everyone is looking for new solutions. What would an improved oral health care system and Medicaid model look like? This paper describes Minnesota's Oral Health Care Solutions Project that seeks to answer this question and highlights the implications of a new model for people with special needs. The low reimbursements and administrative burdens of Minnesota's Medicaid program have led many dentists to reduce or stop seeing public program patients. As a result, many people with special needs have been unable to obtain routine dental care and therefore seek treatment in emergency rooms.

Delivery of Health Care↗
PubMed2006

Management of trauma in special populations after a disaster.

Special populations are particularly vulnerable to mental health problems in the aftermath of a disaster. Efficient delivery of mental health services, the integrated use of psychosocial services and mental health facilities, and the active intervention of trained community health care workers can offer effective management of the psychosocial problems of special populations. Women, children, adolescents, the poor, the elderly, and individuals with preexisting health problems have been identified as special populations who often suffer psychological morbidity as a result of a catastrophic disaster. Understanding the cultural, ethnic, and socioeconomic factors in a postdisaster situation is crucial to helping special populations overcome debilitating mental illness and declining quality of life. Planning the delivery of mental health services is critical and includes hazard mapping to identify vulnerable geographic and social areas, screening instruments to identify at-risk populations, and education of community leaders and health care workers. An integrated approach using psychosocial and institutionalized interventions can provide better outcomes than either approach alone. A community-based approach with trained grassroots health care workers can provide effective psychosocial support and rehabilitation services.

Adolescent↗
PubMed2006

Specificity and specialization of congeneric monogeneans parasitizing cyprinid fish.

Patterns and likely processes connected with evolution of host specificity in congeneric monogeneans parasitizing fish species of the Cyprinidae were investigated. A total of 51 Dactylogyrus species was included. We investigated (1) the link between host specificity and parasite phylogeny; (2) the morphometric correlates of host specificity, parasite body size, and variables of attachment organs important for host specificity; (3) the evolution of morphological adaptation, that is, attachment organ; (4) the determinants of host specificity following the hypothesis of specialization on more predictable resources considering maximal body size, maximal longevity, and abundance as measures of host predictability; and (5) the potential link between host specificity and parasite diversification. Host specificity, expressed as an index of host specificity including phylogenetic and taxonomic relatedness of hosts, was partially associated with parasite phylogeny, but no significant contribution of host phylogeny was found. The mapping of host specificity into the phylogenetic tree suggests that being specialist is not a derived condition for Dactylogyrus species. The different morphometric traits of the attachment apparatus seem to be selected in connection with specialization of specialist parasites and other traits favored as adaptations in generalist parasites. Parasites widespread on several host species reach higher abundance within hosts, which supports the hypothesis of ecological specialization. When separating specialists and generalists, we confirmed the hypothesis of specialization on a predictable resource; that is, specialists with larger anchors tend to live on fish species with larger body size and greater longevity, which could be also interpreted as a mechanism for optimizing morphological adaptation. We demonstrated that ecology of host species could also be recognized as an important determinant of host specificity. The mapping of morphological characters of the attachment organ onto the parasite phylogenetic tree reveals that morphological evolution of the attachment organ is connected with host specificity in the context of fish relatedness, especially at the level of host subfamilies. Finally, we did not find that host specificity leads to parasite diversification in congeneric monogeneans.

Animals↗
PubMed2005

Laws, causation, and explanation in the special sciences.

There is the general philosophical question concerning the relationship between physics, which is often taken to be our fundamental and all-encompassing science, on one hand and the special sciences, such as biology and psychology, each of which deals with phenomena in some specially restricted domain, on the other. This paper deals with a narrower question: Are there laws in the special sciences, laws like those we find, or expect to find, in basic physics? Three arguments that are intended to show that there are no such laws are presented and examined. The paper ends with brief remarks concerning the implications of these arguments for explanation and causation in the special sciences.

Biological Science Disciplines↗
PubMed2006

[The role in cancer chemotherapy of "a pharmacist specialized in cancer"].

A pharmacist system specialized in cancer has been established to authorize a clinical pharmacist to provide safe and sure support for cancer chemotherapy. A pharmacist specialized in cancer supports a protocol that has became complicated or involves management of anticancer agent side effects from a professional standpoint. The examination certifying a pharmacist specialized in cancer is very difficult, sophisticated (certification by pharmacists society) and requiring first-hand clinical experience of cancer chemotherapy to be eligible necessary for the examination. 41 pharmacists specialized in cancer were qualified in March of 2006.

Education, Pharmacy↗
PubMed2006

[Specialties in dentistry. 4. Post-academic specialization in geriatric dentistry].

In recent years, a specialization in geriatric dentistry has been established and along with it an educational programme. A specialist in geriatric dentistry is a dentist general practitioner with special knowledge and skills for delivering oral care to frail elderly people. The educational programme aims at an increase in dentists serving in geriatric care who are well prepared for delivering care. In the programme attention is paid to the special aspects of care delivery and the special somatic, mental, and social characteristics of frail elderly people. The goal is to formulate an individual oral care programme for every frail elderly person. An individual oral care programme may contain 5 different oral care activities: continuing care, prevention, support, treatments, and evaluation. These activities define the scope of specialists in geriatric dentistry. This scope in turn defines the profile of required knowledge and skills, and the profile is the foundation of the educational objectives of the educational programme. The educational programme contains 7 modules: affinity; somatic and mental disabilities; communicative skills and coping with behavioural disturbances; emergency medical care; history taking, assessment, prevention, treatments and evaluation; organization and legislation; scientific training.

Aged↗
PubMed1990

Children with special needs in The Netherlands: impaired hearing, adolescent pregnancy, and myelomeningocele.

In the Netherlands, treatment and management of children with special needs is characterized by the absence of financial barriers to care and the existence of a number of specialized services. For hearing-impaired children, there are special audiologic centers and special schools. Adolescents at risk of unintended pregnancy are protected through education and a dedicated system of family planning clinics. Children with multiple handicaps, such as those associated with myelomeningocele, face greater difficulties but still have an array of services available to them at little or no cost. Families are sheltered from excessive expense through social insurance.

Adolescent↗
PubMedDate not supplied

[The "legal rights of the elderly"--is it desirable, to institute special legal provisions for the elderly?].

Legal problems of the elderly are, besides social legislation, a rather small topic of interest in the field of law and jurisprudence in the FRG. There are some provisions in the social legislation (old age insurance; health insurance) but no special provisions in tax law for the needs of the elderly. Most of the interesting legal provisions, even if old-age matters prevail, are general, and not specific old-age-related provisions. But we can see that in the legal practice, especially in the courts, interests of the elderly are sometimes taken in consideration, for example ventue law and in penal law at the prosecution level. One may raise the question whether a new field of "Laws for the Elderly" should be created. Such a specialty could comprise all the legal provisions that concern the elderly, particularly as regards their special age-related needs and problems. A law containing special measures prohibiting old-age-discrimination would be problematic in regards to equal treatment of other population groups, because equal treatment is a general constitutional rule. It seems to be on the right track to include old-age needs and problems in general legal provisions that also cover the population groups which are in similar positions. This is not to say that special provisions for the elderly should not be arranged if only those persons are concerned.

Aged↗
PubMed1990

[The need of special services in the future care of the mentally retarded].

A proposal for deinstitutionalization of the mentally retarded in Norway passed the Norwegian Storting in May 1988. The Ministry of Health and Social Affairs has prepared guidelines for planning and implenting this reform. On 1 January 1991 the responsibility for providing the necessary services was transferred to the municipalities. Many problems have to be solved in order to ensure that the life of each mentally retarded person is qualitatively improved after normalization and integration into society. In July 1989 the Ministry of Health and Social Affairs issued a document which assumed that necessary specialists and special services for the mentally retarded already exist, and are being used. Our study has questioned this assumption as being incorrect or incomplete. We interviewed persons in charge of the system of health care in all 19 Norwegian counties. Our conclusions are as follows: The mentally retarded do receive specialist services in various areas of somatic medicine. Their needs as regards psychiatric care are not taken care of by psychiatric specialists in hospitals or at out-patient facilities. Data shows that the system of institutionalized health care for the mentally retarded provides unique services which are best described as systematically applied behaviour analyses. Such special competence is often lacking in the Norwegian health services otherwise. In order to ensure that the mentally retarded will receive the best possible care, this competence must be integrated into the future system of care. It is most importance to consider these problems without delay. This article also discusses organizing special training and treatment for the mentally retarded themselves and special training for the persons providing the care.

Health Planning Guidelines↗
PubMed1989

Agrin-induced specializations contain cytoplasmic, membrane, and extracellular matrix-associated components of the postsynaptic apparatus.

The aims of the studies reported here were to determine the extent to which the specializations induced by agrin on cultured chick myotubes resemble the postsynaptic apparatus and examine how these specializations form. We found that agrin induces the formation of specializations at which at least 6 components of the postsynaptic apparatus are concentrated: one cytoplasmic component [a 43 kDa acetylcholine receptor (AChR)-associated protein], 3 membrane components [AChRs and globular forms of acetylcholinesterase (AChE) and butyrylcholinesterase (BuChE)], and 2 extracellular matrix-associated proteins (A12 asymmetric AChE and a heparan sulfate proteoglycan). The accumulation of AChE and BuChE into agrin-induced aggregates occurred in the absence of any change in the amount, rate of synthesis, accumulation, and release, or molecular forms of either enzyme. Thus, agrin affects primarily the distribution of these components of the postsynaptic apparatus and not their metabolism. Agrin-induced formation of AChR aggregates was not prevented by inhibition of protein synthesis, consistent with our previous results that agrin-induced accumulation of AChRs occurs by lateral migration. The accumulation of components of the extracellular matrix would seem less likely to occur by lateral migration and so might require release of newly synthesized proteins; indeed, formation of aggregates of heparan sulfate proteoglycan was prevented by inhibitors of protein synthesis. Thus, different components of the postsynaptic apparatus accumulate in agrin-induced specializations by different mechanisms.

Acetylcholinesterase↗