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For each design of a package for the transport of radioactive material, it is necessary to demonstrate compliance with national and international transport regulations as applicable. It is recommended to combine all information necessary to demonstrate compliance in a package design safety report. The European Technical Guide is intended to assist in the preparation of such a package design safety report for use in all European countries. The development of this guide has been initiated and supported by the European Commission (EC) to improve harmonisation in this field in Europe. Starting from 2005, a draft of the guide has been produced with inputs from Belgium, France, Germany, Spain, UK, the World Nuclear Transport Institute (WNTI) and AREVA. This paper describes the scope, structure and contents of the draft of the Technical Guide. The guide is based on the IAEA TS-R-1 Regulations which are generally consistent with the regulations for the road, rail, sea, inland waterways and air modes of transport, namely, ADR, RID, IMDG code, ADN and ICAO respectively, which have to be applied in European countries. The guide is applicable to all types of packages. It proposes a structure and a minimum contents for the safety report to assist the applicant in the case of a package design subject to competent authority approval, and to assist the package designer in the case of a package not requiring competent authority approval in demonstrating compliance with the provisions of TS-R-1 applicable to the respective package type. The guide also includes a matrix of paragraph numbers of IAEA TS-R-1 and modal regulations applicable to each package type to support demonstration of compliance with all regulatory requirements that have to be addressed for each package type. Further guidance for the scope of the contents of a package design safety report specifically related to each package type is given in annexes to the guide. It is intended in the further development of the guide to provide the results to IAEA to support worldwide harmonisation in this matter. [ABSTRACT FROM AUTHOR]

OBJECTIVE: Some monoclonal antibodies (mAb) to type II collagen (CII) are arthritogenic upon passive transfer to mice. We undertook this study to investigate whether such mAb are pathogenic in the absence of mediators of inflammation. METHODS: The arthritogenic mAb CIIC1 and M2139, and the nonarthritogenic mAb CIIF4, each reactive with a distinct and well-defined conformational epitope on CII, were compared with control mAb GAD6. Bovine chondrocytes were cultured with one of the mAb, and on days 3, 6, and 9, antibody binding by chondrocytes and newly synthesized extracellular matrix (ECM) was examined by immunofluorescence, morphologic effects were studied by electron microscopy, and synthesis of matrix components was determined by metabolic labeling with (3)H-proline for collagen and (35)S-sulfate for proteoglycans. RESULTS: All 3 mAb to CII bound to the matrix. CIIC1 and M2139 adversely affected the cultures, whereas CIIF4 did not. CIIC1 caused disorganization of CII fibrils in the ECM without affecting chondrocyte morphology, and increased matrix synthesis. M2139 caused thickening and aggregation of CII fibrils in the ECM and abnormal chondrocyte morphology but matrix synthesis was unaffected. CONCLUSION: The unique arthritogenic capacity of particular anti-CII mAb upon passive transfer could be explained by their adverse, albeit differing, effects in primary cultures of chondrocytes. Such effects occur independent of inflammation mediators and are related to the epitope specificity of the mAb. Interference with the structural integrity of CII could precede, and even initiate, the inflammatory expression of disease. [ABSTRACT FROM AUTHOR]

Cutaneous hypersensitivity and antibody-producing capacity were assessed in patients with lepromatous leprosy with defective immunity, by immunizing them with monomeric flagellin from Salmonella adelaide. Results were compared with those of controls, matched for age and sex, derived from similar socioeconomic stratum, but without any defect of the immunological system. In contrast to the normal individuals, who showed Jones-Mote type of hypersensitivity, no lepromatous patient could mount any 'delayed-in-lime' cutaneous hypersensitivity reaction against an intradermal challenge of monomeric Hagellin. However, when immunized through the subcutaneous route, both groups could produce adequate amounts of specific scrum antibody. In addition to this unique split tolerance found in all lepromatous patients, some patients showed low levels of 'natural' IgM antibody, reduced formation of specific antibody when immunized through the subcutaneous route, und incomplete maturation of IgG class of anti-flagellin antibody. When immunized by the intradermal route, however, production of both anti-flagellin antibody and maturation of IgG antibody was significantly inhibited in normal adults but not in lepromatous patients. Thus, contrary to the earlier concept of hyperactivity of the humoral immune apparatus in lepromatous leprosy, the present study detected B-cell hypofunction in some patients. [ABSTRACT FROM AUTHOR]

To study the effect of fibromyalgia syndrome (FS) on the expression of systemic lupus erythematosus (SLE) and on the measurement of disease activity, we performed a cross-sectional study of subjects with SLE. Eighty-seven subjects were studied and 22 (25.3%), all female, had FS (Yunus' criteria). Disease activity and organ system involvement were assessed using the systemic lupus activity measure (SLAM) and using 10 cm visual analogue scales (VAS) completed by both physician and patient. No significant difference between FS and non-FS groups in the objective measurement of disease activity was present, median (range) SLAM scores being 5 (0-18) and 6 (0-24), respectively (NS). Similarly, expression of SLE, as measured by the prevalence of specific organ system involvement, was similar in the two groups. In contrast the prevalence of glucocorticoid use, antibodies to DSDNA and fulfilling four ACR criteria was higher in the non-FS group. The rating of SLE disease activity was affected by concomitant FS. Physician and patient disease activity VAS correlated significantly with SLAM scores in non-FS subjects (P < 0.001, Spearman analysis), whereas in FS subjects, neither physician nor patient VAS correlated with SLAM scores. We conclude that FS is prevalent in individuals with SLE and does not affect disease expression but may interfere with the rating of disease activity. [ABSTRACT FROM PUBLISHER]

The clinical and serological features and HLA phenotypes are reported for 11 patients with coexistent features of rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). All patients had a symmetrical small joint polyarthritis and features of SLE such as rash, photosensitivity, oral ulceration, serositis, cytopenia, and biopsy proved lupus nephritis. Eight had hypocomplementaemia. Autoantibodies were characteristic of the two diseases: all patients had rheumatoid factor and antibodies to double stranded DNA, eight (73%) had antibodies to collagen, and five (46%) had antibodies to Ro (SS-A). There was also an overlap of HLA phenotypes. Six patients were DR4 and seven were DR2 or DR3 positive, and of the five patients who were DR4 negative, four shared class I alleles often associated with DR4. If RA and SLE share a common autoimmune dysfunction, those patients who have the two diseases do so because they have genetic determinants of both. [ABSTRACT FROM PUBLISHER]

An improved method is described for growing human T-lymphocyte colonies in agar medium containing phytohaemagglutinin (PHA) and sheep red blood cells (SRBC). Cluster and colony growth was obtained when blood mononuclear cells were plated directly in the agar-medium (one-step procedure) or after incubation of cells in liquid medium with PHA (two-step procedure). In the one-step procedure approximately 1 per 100 cells plated formed a cluster containing four to fifty cells. In the two-step procedure 1 per 20 cells plated formed a cluster or a colony (more than fifty cells). The proliferating cells were shown to be sheep-erythrocyte rosette- forming cells (E-RFC). Optimal proliferation was dependent on the presence of phagocytic cells in the cell suspensions cultured. No growth occurred in cultures depleted of E-RFC. Detailed studies of the cycle, velocity sedimentation, and density of the cells plated showed that the majority of cluster- and colony-forming cells were small non-cycling lymphocytes with a sedimentation velocity of 4 mm/hr, and a density between 1.069 and 1.077 g/cm³. [ABSTRACT FROM AUTHOR]

Examination of fibrous tissue from various sites in the palm reveals the presence of myofibroblasts only in the nodules, underlining their primary role in the production of contracture. [ABSTRACT FROM PUBLISHER]

The article presents a study on the presence of antibodies in the serum of patients with senile dementia. Blood samples of 18 patients with senile dementia at the age range of 72 to 89 years were examined. The study uses two methods namely immunoflourescence and radioimmunoassay. Results of the immunoflourescence procedure showed that no serum reacted specifically with brain tissue. Reaction of two sera to nuclei of brain cells represents nonspecific activity of the two sera. Using radioimmunoassay, it was found that none of the sera showed binding with the iodinated basic protein of myelin. Either method does not detect any antibody specific to brain antigens.