Treatment comparators

Fig. 21. Wedge test results for grit blast/silanc surface treatment compared to PAA. Both surfaces were primed with BR127. Note the expanded crack length scale compared to other figures. Data are from Ref [89].

Edgell ET, Hamilton SH, Revicki DA, et al (1998). Costs of olanzapine treatment compared with haloperidol for schizophrenia results from a randomized clinical trial. Poster presented at the 21st CINP Congress, Glasgow, July 1998. 

For any intervention intended to impact favorably upon human health, it is important to evaluate its safety and efficacy in order to demonstrate that it does not cause harm and it does provide the expected benefit. The gold standard method for evaluating any intervention, whether it be a botanical product, dietary supplement, drug, medical device or medical procedure, is the randomized, clinical trial (RCT). A clinical trial is a type of experiment conducted in human subjects where the effects of at least two interventions are compared. Often, the clinical trial takes the form of an active treatment compared to an inactive control or placebo. 

For cell cycle analysis, HOS cells (1 x 106) were treated with the indicated concentrations (see Table 13.2) of MTX or MTX-LDH for 20h, harvested by trypsin treatment, washed with PBS, and then fixed with cold 70 % ethanol on ice overnight. The fixed cells were incubated with propidium iodide and flow cytometric measurement was carried out. Over 20 h, an increase in the number of cells in the Gl phase resulted from MTX and MTX-LDH treatment compared to untreated cells, indicating arrest at the Gl/S boundary. It is worth noting that the inhibition of the Gl/S transition was more evident in the cells treated with MTX-LDH than in those treated with free MTX (85.59% versus 66.62% at 320pM/ml). This is consistent with... 

For regeneration to be technically viable, it must be able to remove deposited vanadium and nickel quantitatively as well as the carbonaceous coke which was co-deposited. The catalyti-cally active metals should remain unaffected in amount, chemistry, and state of dispersion. The alumina support should remain intact, with the surface area, pore-size distribution and crush strength after treatment comparable to that of the original. To be economically viable, the process should be accomplished in a minimum of steps at nearly ambient temperatures and preferably in aqueous solution. The ultimate proof of any such scheme is for the catalytic activity of the regenerated catalyst to be equal to that of a fresh one. 

This means an increase of the flux (J) and water selectivity (P) for the modified membrane - due to the surface properties modification by plasma treatment - comparing to the untreated membrane. 

This major discrepancy almost certainly results from the failure in the assumptions involved in the treatment. In particular, the observed sensitivities of activation energies to small changes in bond length, in this and in many other systems where the sensitivity parameter has been measured, are far greater than can be accounted for by this treatment. (Compare the slopes of the solid and broken lines of Fig. 28 in the region of the data points.)... 

Thermophilic treatment at 50°C left a higher residual supernatant BOD5 than that from similar mean treatment times but lower reaction temperatures (15). However, odour panel assessments of samples from a thermophilic reactor showed a similar relationship between odour and mean treatment time to that provided by equation 9, despite the slightly higher supernatant BOD5, (unpublished). This apparent contradiction is probably due to the logarithmic nature of the relationship and the small number of samples from thermophilic treatment, compared with the number from lower temperature treatment. 

Such applications of NN as a predictive method make the artificial neural networks another technique of data treatment, comparable to parametric empirical modeling by, for example, numerical regression methods [e.g., 10,11] briefly mentioned in section 16.1. The main advantage of NN is that the network needs not be programmed because it learns from sets of experimental data, which results in the possibility of representing even the most complex implicit functions, and also in better modeling without prescribing a functional form of the actual relationship. Another field of... 

Oronasal application of bull urine accelerated puberty in beef heifers 67% of the animals reached puberty within 8 weeks of treatment, compared with 32% in water-treated controls. Urine-treatedheifers that reached puberty during the experiment calved earlier than water-treated heifers. The calving season also was shorter for urine-treated animals (Izard and Vandenbergh, 1982a). Puberty in female pigs can be accelerated by 1 month if a boar is present (Pearce and Paterson, 1992). 

Alkylation Studies. Several preliminary experiments were completed to compare the extent of alkylation obtained with our coal pretreatment method to that obtained with Sternberg and Liotta alkylation. Results for Wyodak coal are summarized in Table III. Clearly, our procedure provides a very mild alkylation treatment compared with the other two methods and does not appear to be sensitive to differences in alkyl chain length (methyl vs. propyl). The increase in THF solubiliw was also small this result again suggests only a small extent of alkylation and in addition, shows that only minimal ion exchange (for example Ca by H ) occurred in the coal mineral matter. The effect of each pretreatment method on low severity liquefaction reactivity is discussed in the next section. 

Multiple endpoints - in which two treatments compared with many endpoints. 

Conventionally this is interpreted as meaning that if NNT patients are treated with each treatment, one additional patient will benefit from being treated with the new treatment compared to the control. Applying this definition to the mortality data from the Hindle et al. study gives an NNTofl/(0.161—0.063) = 10.83. Conventionally this is interpreted as meaning that approximately 11 patients need to be treated intrathecally to save one life. 

S.5.5.2.3 Historical controls Since many clinical trials are conducted in the same diseases, with the same control treatments there is an obvious desire to make the most use of this potentially valuable information. Can we compare the results of a new treatment in a group of patients with a group of control patients extracted from a historical database For example, suppose we are testing a new treatment for migraine headache and 60% of patients improve in the first 2 h post-treatment, compared to 30% in a group of historical control patients treated who had been treated with the current gold standard. Are we able to conclude that the new treatment is preferable to the gold standard ... 

With appropriate attention to patient preparation, FDG PET in diabetics for assessing viability reportedly has high sensitivity (92%) and specificity (85%) [96]. A perfusion FDG mismatch on PET in diabetic patients reliably identifies high risk for cardiac death with medical treatment compared to revascularization [97]. 

Selection of appropriate treatment alternatives in a clinical smdy is essential for a useful economic evaluation of a pharmaceutical therapy. This issue is both a clinical and an economic one. Comparators can be the most common alternative therapies for a condition or the lowest possible cost alternatives, even when not frequently used. However, in pharmacoeconomic studies, treatment comparators may be inappropriately selected as much for their relatively high price as for their likely effectiveness. Phase III smdies have special limitations in this regard, because agents will be compared against the... 

In the RCT in which participants received memantine and donepezil in combination, less deterioration in cognitive function was recorded in participants receiving combined treatment compared with donepezil alone, as measured by the SIB (mean change from baseline at end point for memantine plus donepezil and donepezil alone was 0.9 and —2.5, respectively, p < 0.001). Memantine also improves behavioural symptoms. 

Certain tissues of the female reproductive tract, which are subject to the trophic action of hormones, exhibit a high frequency of neoplasia. Cancer of the breast, the second most common form of cancer in American women, and the rarer endometrial cancer in women, are often responsive to treatments with estrogens or progestins. The toxicity of these hormonal treatments compared with standard cancer chemotherapy is low. 

A significant p-value coming out of this test is indicative of a shift or trend in one direction across these categories for one treatment compared to the other. In the example it is illustrative to look at the percentages in the various categories as... 

Interim analyses arise when we want to look at the data as it accumulates with the possibility of stopping the trial at the interim stage if the data suggests, for example, overwhelming efficacy of the test treatment compared to placebo. If we were to introduce, for example, two interim looks in additional to the final... 

As mentioned in Section 1.10, there are essentially two areas where we would want to conduct non-inferiority trials firstly where inclusion of a placebo for either practical or ethical issues is not possible and we are therefore looking to demonstrate the efficacy of the new treatment indirectly by showing similarity to an established active treatment and secondly where it is necessary to show that there is no important loss of efficacy for a new treatment compared to an existing treatment. 

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