Do cancer patients fully understand clinical trial participation? A pilot study to assess informed consent and patient expectations

Background. Accepted practices of informed consent often result in suboptimal patient understanding of research studies.Methods. This pilot study aimed to assess trial-specific tailored materials, compared to a widely used generic booklet about clinical trials, randomly assigned to 118 candidates for cancer clinical trials. Study outcomes were: satisfaction with decision-making; satisfaction with materials; and subjective understanding of the clinical trial.Results. There were no major differences between groups. Participants rated tailored materials higher as a useful reference.Conclusions. Trial-specific materials hold utility for reference during clinical trials. Studies of informed consent are feasible, although important factors limit research.     

Cytomorphometric analysis of vaginal cells during normal cycle, under oral contraceptive therapy or in-vitro fertilization stimulation protocol

A cytomorphometric analysis of superficial vaginal cells inwomen in three groups of different types of hormonal concentrationwas made. There were 15 women in each group. Group I was studiedduring a natural cycle, group II under oral contraceptive therapyand group III during an in-vitro fertilization (IVF) stimulationprotocol. Morphometric parameters were measured on an imageanalyser. The area, perimeter and several form factors weremeasured separately for nuclei and cytoplasm. The nucleus:cytoplasmicratio was also determined. The cytoplasmic area was significantlyreduced in group II and was associated with a statisticallysignificant reduction of the nuclear area. The nucleus:cytoplasmicratio appeared significantly increased in group II and reducedin group III. Low oestradiol impregnation obtained with an oralminidosed contraceptive interfered with vaginal cell maturation.High oestradiol concentrations obtained during IVF protocolsinduced marked nuclear pycnosis but did not induce supra-physiologicalcell enlargement. Maximal cell size is genetically regulatedaccording to Driesch's law of volume invariance and hormonalover-stimulation has no effect on cell size. The nucleus:cytoplasmicratio appears to be a powerful parameter reflecting the oppositeeffects of hormones on cell compartments.     

Effects of scopolamine,trimipramine and diazepam on explicit memory and repetition priming in healthy volunteers

The effects of scopolamine, an anticholinergic drug, of trimipramine, a tricyclic antidepressant with both anticholinergic and sedative properties, of diazepam and a placebo, on explicit memory and repetition priming were assessed using a free-recall task and a word-stem completion task. Forty-eight healthy volunteers took part in this double-blind study. Diazepam provoked a dissociation between free recall, which was profoundly impaired, and word completion, which was spared. No significant changes in memory performances were observed in the scopolamine group; however, a significant correlation between explicit and implicit memory performances was observed in this group. At the low dose used, the effects of trimipramine on memory were mild. The results suggest that the cholinergic system is involved in the priming effect.     

A Comparison of Oral and Rectal Absorption of L-Dopa Esters in Rats and Mice

Short-chain alkyl esters of L-dopa were administered to rats and mice via oral and rectal routes. Plasma L-dopa esters and L-dopa were determined in the systemic and portal circulation by HPLC. A comparison of isopropyl, butyl, and 4-hydroxybutyl esters of L-dopa demonstrated significantly higher levels of the esters in both systemic and portal blood samples following rectal administration than following oral administration. In most cases, oral administration resulted in nondetectable (<0.01 µg/ml) levels of the esters in plasma. Correspondingly, the plasma levels of L-dopa itself were consistently higher following rectal administration. At very high oral doses (500 mg L-dopa equivalents/kg body weight), systemic plasma levels of the butyl ester could be detected (1.25 µg/ml at 10 min), which might indicate saturation of the esterase activity of the small intestine. These studies indicate that the systemic availability of L-dopa from short-chain alkyl esters of L-dopa may be best optimized by rectal administration, which avoids the relatively high esterase activity characteristic of the small intestine.     

Perceived Risk of Fighting and Actual Fighting Behavior Among Middle School Students

ABSTRACT: This study evaluated the association between perceived risk of fighting and actual fighting behavior among middle school students and determined if that relationship was modified by race, gender, or grade level. Survey data were obtained from a stratified random sample of 517 Black and White students in a county school district in Maryland. Most students (72%) perceived fighting to be high-risk, but 20% reported fighting on a regular basis. The effect of risk perception (RP) on fighting behavior varied by race. Independent of grade and gender effects, students who believed fighting to be low-risk were more likely to fight on a regular basis than those with high RP (odds ratio for Blacks = 3.1; odds ratio for Whites = 5.4). School violence prevention education must include an emphasis on the health risks of fighting and attention to cultural differences in risk perception.     

On language laterality in normal dextrals and sinistrals: Results from the Bilateral Object Naming Latency Task

Rasmussen and Milner [N.Y. Acad. Sci. Vol. 299, pp. 355–379, 1977] published data on late-lesioned (after age 6) epileptic patients who had suffered left hemisphere lesions. They estimated that left hemisphere dominance occurred in 96% of dextrals and 70% of sinistrals. These figures have been regarded as valid estimates for normal dextrals and sinistrals. We administered the Bilateral Object Naming Latency Task, a verbal tachistoscopic task with very good psychometric properties, to 188 dextral and 72 sinistral normals. Results showed that 93.6% of the dextrals and 80.3% of the sinistrals were left hemisphere dominant. A consideration of results from a number of carefully conducted dichotic listening studies suggests, as do present results, that the 70% left-dominance estimate of Rasmussen and Milner for normal sinistrals may be too low by about 10%. It is suggested that ‘bilateral dominance’, present in 15% of the epileptic sinistrals of Rasmussen and Milner, may be much less common in normal sinistrals.