Clinical observations INDEX

Beside the clinical observations the patients have been examined for the amount of haemoglobin and erythrocytes, the colour index of the blood, the amount of... 

The improvement was not only clinical, but also bacteriological, reducing the morphological index (percent of viable bacteria) to 0. During the treatment, no side-effects were observed either clinically or by biological tests (24-). Continued treatment over a period of another 6 months confirmed the definite effectiveness of the drug against leprosy. 

In human studies, flaxseed consumption has had positive impacts on carcinogenesis and parallel observations from animal studies. A doubleblind, placebo-controlled, prospective clinical trial involving 39 women, newly diagnosed with breast tumors, was completed to evaluate the effect of flaxseed consumption on tumor growth (Thompson et al., 2000). Subjects given flaxseed (25 g/day) diets had reduced tumor cell proliferation and c-erB-2 expression, and an increased apoptosis index compared with women who ate whole-wheat muffins. 

Based upon these observations and following Phase I safety studies, a Phase II randomized, double-blind, controlled clinical trial was undertaken to treat active ulcerative colitis with escalating doses of ISIS 2302. Based on an intent-to-treat analysis, 59% (13/22) of patients treated daily with 240 mg ISIS 2302 enema over six weeks achieved a positive response, as measured by Disease Activity Index (DAI)... 

Tangier disease is an extremely rare genetic disorder with fewer than 100 cases reported since the index cases in 1961. Clinical signs and symptoms are variable and may depend on the age of the patients. For instance, signs of neuropathy were not observed in T. L. and E. L., in contrast to our 32-year-old patient. Assmann and colleagues (2001) have succinctly compiled the reported findings (Table 15-1), most of which are discussed here. 

The principle of estimating a therapeutic index prior to clinical trials typically involves determining the no observable adverse effect level (NOAEL) and comparing that to the projected human dose. In providing the estimate, the efficacious dose is typically obtained from in vitro data with human cells or tissues and in vivo preclinical pharmacology studies that involve animal disease models. Not infrequently the species used to estimate the toxic level is different from the species used to estimate an efficacious level. Thus the therapeutic index is not a true ratio as the units (species and/or conditions) are often different. On the other hand, if one were to obtain information relating to toxicity as well as efficacy from studies employing animal models of disease, a direct estimate of therapeutic index could be made provided that appropriate models had been characterized or validated in the relevant species. 

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