Case report

Human data include information from case reports (e.g., poisonings), clinical examinations, experimental studies in volunteers, experiences from the working environment, epidemiological studies, and meta-analyses. 

In relation to a hazard assessment, the relative lack of sensitivity of human data may cause particular difficulty. Therefore, negative human data cannot be used to override the positive findings in animals, unless it has been demonstrated that the mode of action of a certain toxic response observed in animals is not relevant for humans. In such a case, a full justification is required. 

Case reports describe a particular effect observed in an individual or a group of individuals in which an exposure to a substance has occurred, often accidentally or in suicidal attempts. Information can be obtained from published case reports or from poison information centers. 

Information from case reports is primarily on acute toxic effects and the clinical symptoms can in some cases be rather well described. For some substances, however, effects may be observed only after a latency period and therefore, may not be recognized as being linked to the poisoning incident. 

In poisoning cases, the exposure concentration or dose is often unknown and thus, a dose-effect relationship is difficult to evaluate. Therefore, information from poisoning cases generally has a limited use in the hazard assessment. An exception is identification of acute toxic effects. Furthermore, poisoning cases can also indicate whether a substance can become systemically available  

In the last several decades, there have been several studies in experimental animals, case reports in humans, case studies in humans, and epidemiological studies in humans on the effects of solvents on the kidney, both acutely and chronically. The scope of diis chapter is the clinical chronic effects of solvents on the kidney (chronic nephrotoxicology). 

While the exact mechanism is not known and various mechanisms have been postulated, it is reasonable to accept a mechanistic approach which takes into account genetic, environmental, susceptibility (such as pre-existing diseases including hypertensive kidney disease and diabetes), direct tubular toxicity, permeability changes and immunosuppression. 

The earlier doeumentation of chronic renal disease and hydrocarbon exposure consists of case reports, and this data was summarized by Churchill et al. describing Goodpasture s syndrome in 15 adults, epimembranous glomerulonephritis in 5 adults, and subacute proliferative glomerulonephritis in one adult. The hydrocarbon exposures were for solvents in 12 patients, gasoline in 4, gasoline-based paint in 3, jet fuek mineral turpentine and un- 

Klavis and Drommer 1 Goodpasture s Gasoline-based paint spray 

Kleinknecht, et al. 2 anti-GBM nephritis Organic solvent vapors 

Beime and Brennan 5 1 Goodpasture s RPGN Degreasing and paint Solvents and jet fuel 

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Monographs on rockets and rocket propellants by the National Aeronautics and Space Administration (NASA), Lewis Research Center, Cleveland. These iaclude the foUowiag Solid Propellant Selection and Characteri tion, Report SP-8064,1971 Solid Rocket Motor Peformance, Report SP-8039,1971 Solid Rocket Motor Igniters, Report SP-8051,1971 Solid Rocket Motor Metal Cases, Report SP-8025, 1970, and Captive Eire Testing of Solid Rocket Motors, Report SP-8041,1971. 

In some cases, reported data do not satisfy a consistency check, but these may be the only available data. In that case, it may be possible to smooth the data in order to obtain a set of partial molar quantities that is thermodynamically consistent. The procedure is simply to reconstmct the total molar property by a weighted mole fraction average of the n measured partial molar values and then recalculate normalised partial molar quantities. The new set should always be consistent. 

Use of DMF as a solvent for the oxidation of l-o1efins has been reported by Clement and Selwitz. The method requires only a catalytic amount of PdCl2 and gives satisfactory yields under mild conditions. A small amount of olefin migration product is the only noticeable contaminant in the cases reported. The procedure can be applied satisfactorily to various 1-olefins with other functional groups. This useful synthetic method for the preparation of methyl ketones has been applied extensively in the syntheses of natural products such as steroids,macrolides, dihydrojasmone, and muscone. " A comprehensive review article on the palladium-catalyzed oxidation of olefins has... 

Literature from industrial experience, especially individual case reports showing relationship between exposure to a chemical agent and specific adverse effects... 

Protonation of the a-carbanion (50), which is formed both in the reduction of enones and ketol acetates, probably first affords the neutral enol and is followed by its ketonization. Zimmerman has discussed the stereochemistry of the ketonization of enols and has shown that in eertain cases steric factors may lead to kinetically controlled formation of the thermodynamically less stable ketone isomer. Steroidal unsaturated ketones and ketol acetates that could form epimeric products at the a-carbon atom appear to yield the thermodynamically stable isomers. In most of the cases reported, however, equilibration might have occurred during isolation of the products so that definitive conclusions are not possible. 

Nitration proceeds readily in benzofuroxan, giving first the 4-nitro, then the 4,6-dinitro compound. 6-Nitrobenzofuroxan, according to Drost, is nitrated further in the adjacent 6-position. Bailey and Case reported that the major product is the 4,6-dinitro compound, but they did succeed in isolating a small amount of the 6,6-dinitro derivative from the reaction. 

Isoindolines comprise a group of well-characterized and easily synthesized substances, and being at the next stable reduction state below that of isoindoles, they constitute suitable precursors for synthesis of the latter. In principle, either oxidation or elimination from isoindolines should lead to isoindoles however, in view of the susceptibility of isoindoles to further oxidation, elimination has been preferred, and in all cases reported the leaving group has been placed on nitrogen rather than carbon. 

A number of enantioselective hydrogenation reactions in ionic liquids have also been described. In all cases reported so far, the role of the ionic liquid was mainly to open up a new, facile way to recycle the expensive chiral metal complex used as the hydrogenation catalyst. 

Niobium like tantalum relies for its corrosion resistance on a highly adherent passive oxide film it is however not as resistant as tantalum in the more aggressive media. In no case reported in the literature is niobium inert to corrosives that attack tantalum. Niobium has not therefore been used extensively for corrosion resistant applications and little information is available on its performance in service conditions. It is more susceptible than tantalum to embrittlement by hydrogen and to corrosion by many aqueous corrodants. Although it is possible to prevent hydrogen embrittlement of niobium under some conditions by contacting it with platinum the method does not seem to be broadly effective. Niobium is attacked at room temperature by hydrofluoric acid and at 100°C by concentrated hydrochloric, sulphuric and phosphoric acids. It is embrittled by sodium hydroxide presumably as the result of hydrogen absorption and it is not suited for use with sodium sulphide. 

Anon, Bombs, Aircraft. H.C. 4000 lb Mark 8 (with Aluminum Case). Report of Rough Usage Trials of Bombs Filled with Minol 2 , BritOrdnBoardProc 33292 (April 1946)... 

M.8 In the reaction of hydrogen gas (H,) and oxygen gas (O,) to form water vapor, which is the limiting reactant in each situation What is the maximum quantity of water vapor that can be produced in each case Report your answer using the units in parentheses, (a) 1.0 g of hydrogen gas and 0.25 mol 02(g) (in moles of H,0) (b) 100 H, molecules and 40 02 molecules (in H20 molecules). 

All protocol-required data are recorded at the trial site on Case Report Forms (CRFs), which may be in either electronic or hard-copy format. Data for individual subjects are recorded on separate CRFs. The CRFs are used to transfer trial data to the sponsor for analysis and evaluation. 

Signed protocol and amendments, if any and sample Case Report Form (CRF)... 

The following points are worthy of note in terms of the placement of data. In the case of studies with multiple objectives, reports should be placed in the section corresponding to their primary purpose. Reports of laboratory studies conducted with human materials to investigate pharmacokinetic effects should be placed in Section 5.3.2 of the clinical module, as opposed to the non-clinical module. A US submission requires that the individual case report forms of all trial subjects that died or were dropped from a study due to adverse events are included in Section 5.3.7. 

Case Report Forms and Individual Patient Listings. 5.4 Literature References... 

The investigator s brochure, the case report forms, the confirmation of insurance of subjects and the documents used to obtain informed consent... 

Since the recognition of the role of chlorine in catalytic ozone destruction, increasing effort has been devoted to finding replacements. In most cases reported so far, the replacements are partially halogenated molecules that retain one or more hydrogen atoms (HCFCs and HFC s). The presence of H-atoms gives HO a handle (via H-atom abstractions such as R4) for their tropospheric... 

Marks (1978) reviewed published reports of benzodia2epine dependence in the literature from 1961 to 1977 and estimated that benzodiazepine dependence occurred in one case per 50 million patient-months of use. His assessment of risk has been criticized, however, because published case reports tend to occur less frequently than the phenomenon they describe. Benzodiazepine dependence case reports peaked between 1969 and 1973, about 10 years after the introduction of the drugs (Petursson and Lader 1981a). 

Mannion V Case report adverse effects of taking tricyclic antidepressants and smoking marijuana. Can Earn Physician 45 2683—2684, 1999... 

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