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PubMed1988

Organization, review, and administration of cooperative studies (Greenberg Report): a report from the Heart Special Project Committee to the National Advisory Heart Council, May 1967.

Cooperative studies have been designed as a means of obtaining definite answers to significant questions not readily answerable by other means. Such studies should be initiated only if an important problem needs a rapid solution, the study is feasible and likely to answer the problem, and strong and stable leadership are assured. Protocol and operating procedures must be kept as simple as possible. Control of performance at all levels must be built into the structure. Organizational components should include: (a) a Policy or Advisory Board, (b) an Executive or Steering Committee, (c) a Coordinating Center, and (d) data-contributing participants. All of these components must interrelate with each other and with National Heart Institute staff and, through the staff, with scientific review groups and the National Advisory Heart Council. A chart of organization is shown in Figure 1. The most important position is that of Chairman of the Steering Committee; the key component is the Coordinating Center. The performance of the Coordinating Center is continuously dependent on full-time, highly disciplined leadership that must continually maintain active lines of communication with all participants. Failure to achieve this seriously undermines the effectiveness and value of the study. Participation in a cooperative study, with required adherence to a common protocol, can divert some scientists from original research. Conversely, others may be introduced to research methodology through participation. The benefits that can be achieved only through cooperative efforts must be carefully balanced against any adverse effects of encouraging large numbers of investigators to work in cooperative studies. Exceedingly complex value judgments are required of reviewers, who must constantly keep in mind the need to maintain a reasonable balance within the funds appropriated for research. Their deliberations should include an evaluation of technical approaches, organization, biostatistical aspects, duration, and budget. Comprehensive annual progress reports and recall of former consultants could facilitate continuity of review. Free communication between the National Advisory Heart Council and the initial review groups is essential to enhance working relationships and understanding between these two levels of review. Approval of a preliminary study should carry with it a degree of commitment to a major study if feasibility can be demonstrated and adequate methodology developed.(ABSTRACT TRUNCATED AT 400 WORDS)

Clinical Protocols↗
PubMed2002

Distribution of nickel, zinc, and copper in rat organs after oral administration of nickel(II) chloride.

The distribution of Ni administered as NiCl2 x 6H2O in the drinking water (300 and 1200 ppm Ni for 90 d) was studied using male Wistar rats. Next, the effect of Ni on the concentration of zinc (Zn) and copper (Cu) in selected organs and serum was measured. The metals were analyzed in the liver, kidney, lung, spleen, brain, and serum by electrothermal (Ni) or flame (Zn, Cu) atomic absorption spectrophotometry. The results indicate that exposed rats drank less nickel solutions than the volume of water drunk by controls, but there was no mortality of animals. In comparison to control animals, a very high increase in Ni levels was found in the kidney and then lung and serum of all exposed rats. In the liver, spleen, and brain, the metal accumulation was lower. A directly proportional relation between the nickel intake and its deposition was observed in the collected organs and in the serum. The metal level did not change significantly in the course of exposure (the first analysis was after 30 d). The administration of 300 ppm Ni did not affect the zinc and copper concentration in studied organs, except the serum, where zinc content was significantly reduced. At a dose of 1200 ppm Ni, these metals were found to be depressed in the liver, kidney, serum (zinc), and copper in the kidney.

Administration, Oral↗
PubMed1980

[Effect of raw and extracted-aged garlic juice on growth of young rats and their organs after peroral administration (author's transl)].

The effects of peroral administration of raw garlic juice and extracted-aged garlic juice (garlic extract) were studied with female Wistar strain rats. For the examination, 5, 5 and 10 rats were sacrificed after 3, 8 and 21 days respectively. In the group to which raw garlic juice (5 ml/kg) was administered 5 rats died of the serious stomach injury in 21 days and body weight of still living rats was down at the beginning as food and water intake were decreased. The growth of rats to which raw garlic juice administered group was retarded. The retardation of growth was thought to be caused by the stomach injury due to raw garlic, which limited in fundus. The injured section of stomach was not far gone by the longer administration, however, the mucous secretion of the surface and neck area were stimulated. Swelling of the liver, hypertrophy of the spleen and adrenal glands, and the decrease of erythrocytes with various morphological changes were clearly observed after 3 and 8 days on the group dosed high raw garlic juice, but almost these changes were not observed at any time on extracted-aged garlic juice administration.

Administration, Oral↗
PubMed1978

[Morphological changes in the digestive organs on the administration of the antineoplastic antibiotics, rubomycin and carminomycin].

The effect of antitumour antibiotics, such as rubomycin and karminomycin on the digestive tract as one of the most vulnerable systems during chemotherapy was studied. Investigation of the tongue, oesophagus, stomach, small and large intestine of mice with the current morphological and some histochemical methods showed that the most pronounced changes in the above organs occurred during the first 10 days after the drug administration. The damages were of the same type, i.e. dystrophic changes in the tegmental and granular epithelium with edema and infiltration of the mucosa and tunica submucosa. The drugs induced a decrease in the levels of the nucleic acids, protein and hydrolytic enzymes and impairement of the distribution pattern of these substances in the cells. Karminomycin had a more pronounced effect and its damaging effect was more stable as compared to rubomycin.

Animals↗