Elevation of liver enzymes in multiple dose trials during placebo treatment: are they predictable?

The present study examined the increase in transaminases, especially in ALT in young healthy males during placebo treatment in phase I multiple dose trials. The primary objective was to investigate whether volunteers showing increasing ALT levels also present characteristic patterns of demographic data, laboratory parameters, and vital signs. The secondary objective was to determine whether there is a possibility to predict increases of ALT during a trial by analyzing demographic data and baseline levels of routine safety laboratory parameters and vital signs.

Intravenous thrombolysis with recombinant tissue plasminogen activator for acute hemispheric stroke. The European Cooperative Acute Stroke Study (ECASS).

Objective: To evaluate the efficacy and safety of intravenous thrombolysis using recombinant tissue plasminogen activator (rt-PA) in patients with acute ischemic stroke.

Design: Randomized, prospective, multicenter, double-blind, placebo-controlled clinical trial.

Setting: A total of 75 hospitals in 14 European countries.

[Effect of acarbose on postprandial increase in blood glucose. Additive acute effect of once daily administration in insulin treated diabetes].

Unlabelled: Only few controlled studies have been conducted on the influence of additive treatment with the glucosidase inhibitor acarbose on post-prandial blood sugar levels in insulin-dependent diabetics. To date, the behavior of blood sugar levels under treatment with acarbose has not been studied in insulin-dependent, type II diabetics.

Method: Forty-six diabetics--36 insulin-dependent type II, and 10 type I--were enrolled in a double-blind, placebo-controlled randomized parallel group study with the aim of investigating the influence of acarbose on the primary variable maximum blood glucose increase following a standard breakfast eaten after 7 days of treatment.

[Comparative study of the pharmacokinetics of amitriptyline oxide and trimipramine after single administration in healthy male probands and patients with renal failure].

The pharmacokinetics of the antidepressants amitriptyline oxide and trimipramine and their major metabolites amitriptyline, nor-triptyline and desmethyltrimipramine, were studied in twelve healthy male subjects (aged from 22 to 62 years) and twelve patients (aged from 25 to 73 years) with severe renal impairment (glomerular filtration rate < 10 ml/min). Oral single doses of 60 mg amitriptyline oxide and 50 mg trimipramine, separated by a washout period, were administered to all study participants. Blood and urine samples were collected up to 120 hours after administration.

Suggested isosbestic wavelength calibration in clinical analyses.

I recommend the use of isosbestic points for conveniently checking the wavelength scale of spectrophotometers in the ultraviolet and visible regions. Colorimetric pH indicators, hemoglobin derivatives, and other radiation-absorbing substances that are convertible into stable isomers of different absorption spectra provide a means for calibrating many different wavelengths by comparing the absorptivities of these isomers in equimolar solutions. The method requires no special precautions and results are independent of substance concentration and temperature between 4 and 45 degrees C.