Contemporary clinical trials
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Contemp Clin Trials · Aug 2006
Randomized Controlled TrialRationale and design of the TRANSFACT project phase I: a study to assess the effect of the two different dietary sources of trans fatty acids on cardiovascular risk factors in humans.
Detrimental effects of consumption of industrial trans fatty acids (TFA) from partially hydrogenated vegetable oils (PHVO) on cardiovascular disease (CVD) risk factors are well documented. However, very little information is available on the effect of natural sources of TFA coming from milk fat, dairy products and ruminant meat. In fact, due to the naturally low level of TFA in milk fat, it is almost impossible to conduct a clinical trial with a limited number of subjects (<200). ⋯ We have shown that it is technically feasible to perform a clinical trial on the comparative effects of natural and industrial sources of TFA isomers on CVD risk factors. Results are expected by mid-2006.
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Contemp Clin Trials · Aug 2006
ReviewReview of randomised trials using the post-randomised consent (Zelen's) design.
In 1979, Zelen described a trial method of randomising participants before acquiring consent in order to enhance recruitment to clinical trials. The method has been criticised ethically due to lack of consent and scientifically due to high crossover rates. This paper reviews recent published trials using this method and describes the reasons authors gave for using the method, examines the crossover rates, and looks at the quality of identified trials. ⋯ The most important reason stated by authors for using Zelen's method was to limit bias. Zelen's method, if carefully used, can avoid 'resentful demoralisation' and the Hawthorne effect biasing a trial. Unlike a previous review, we found that crossover was not a problem for most trials.
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Contemp Clin Trials · Aug 2006
Randomized Controlled Trial Multicenter StudyTotal laparoscopic versus open surgery for stage 1 endometrial cancer: the LACE randomized controlled trial.
Endometrial cancer is the most common gynaecological malignancy in Australia and the US. Current standard treatment involves open surgery to remove the uterus, and both tubes and ovaries (TAH). The Laparoscopic Approach to Cancer of the Endometrium (LACE) trial was designed to assess equivalence of performing this in a total laparoscopic approach (TLH). ⋯ The LACE trial will establish the equivalence of a TLH approach for patients with stage 1 endometrial cancer following a two stage protocol to accommodate potential threats to patient recruitment through requests for laparoscopic surgery.