Many-to-one comparisons after safety selection in multi-arm clinical trials.

In phase II platform trials, 'many-to-one' comparisons are performed when K experimental treatments are compared with a common control to identify the most promising treatment(s) to be selected for Phase III trials. However, when sample sizes are limited, such as when the disease of interest is rare, only a single Phase II/III trial addressing both treatment selection and confirmatory efficacy testing may be feasible. In this paper, we suggest a two-step safety selection and testing procedure for such seamless trials.

Evidence, eminence and extrapolation.

A full independent drug development programme to demonstrate efficacy may not be ethical and/or feasible in small populations such as paediatric populations or orphan indications. Different levels of extrapolation from a larger population to smaller target populations are widely used for supporting decisions in this situation. There are guidance documents in drug regulation, where a weakening of the statistical rigour for trials in the target population is mentioned to be an option for dealing with this problem.

Surgical specimens, haemodynamics and long-term outcomes after pulmonary endarterectomy.

Background: Chronic thromboembolic pulmonary hypertension is surgically curable by pulmonary endarterectomy (PEA). It is unclear whether PEA impacts primarily steady state right ventricular afterload (ie, pulmonary vascular resistance (PVR)) or pulsatile right ventricular afterload (ie, pulmonary arterial compliance (C(PA))). Our objectives were to (1) quantify PEA specimens and measure the impact of PEA on PVR and C(PA) in a structure/function study and (2) analyse the effects of haemodynamic changes on long-term survival/freedom of lung transplantation in an outcome study.

Modified solid-phase alloantibody detection for improved crossmatch prediction.

Virtual crossmatching based on single-antigen bead (SAB) assays for the detection of donor-specific antibodies (DSA) has limited accuracy of predicting complement-dependent cytotoxicity crossmatch (CDCXM) results. In this study, 672 crossmatch combinations (32 allosensitized patients tested against cells from 21 high resolution-typed individuals) were analyzed to assess the potential of modified SAB tests in predicting T- or B-cell-CDCXM outcomes. Test modifications included measurement of C4d-fixation to detect complement-activating DSA ([C4d]DSA), or addition of dithiotreitol to abrogate the prozone effect ([IgG/DTT]DSA).

Out of hospital cardiac arrest in Vienna: incidence and outcome.

Aim Of The Study: To determine the incidence of out-of-hospital cardiac arrest and the survival rate of those patients who received CPR in the city of Vienna.

Methods: A cohort of patients with out-of-hospital cardiac arrests and who were treated by the Vienna Ambulance Service between January 1, 2009, and December 31, 2010, were followed up until either death or hospital discharge. The associations of survival and neurological outcome with their potential predictors were analysed using simple logistic regression models.

Correlation of serum procalcitonin with the severity of skin and skin structure infections - a pilot study.

Background: Procalcitonin (PCT) is a specific biomarker for early detection of bacterial infections. While the usefulness of procalcitonin in severe conditions such as sepsis is well established, its relevance in the diagnosis and prognosis of localized cutaneous bacterial infections is unknown. Our aim was to initially evaluate if PCT is a useful parameter for predicting the severity of skin and skin structure infections (SSSI).

Anti-alpha-Gal antibody titres remain unaffected by the consumption of fermented milk containing Lactobacillus casei in healthy adults.

Alpha-Gal is a glycoconjugate present on cell membranes of non-primate mammals and bacteria, but not in humans, who display anti-Gal antibodies (ABs) in high titres. Probiotics contain bacterial strains which colonize the intestinal tract. In the present study, we investigated whether intake of fermented milk containing Lactobacillus casei (FML) affects anti-Gal AB titres.

Total body skin examination for skin cancer screening in patients with focused symptoms.

Background: The value of total body skin examination (TBSE) for skin cancer screening is controversial.

Objective: We sought to determine whether TBSE could be helpful in patients with focused skin symptoms who would not otherwise have undergone TBSE.

Methods: In a prospective, multicenter, cross-sectional study consecutive adult patients were recruited during a period of 18 months.

Rapid induction of hypothermia with a small volume aortic flush during cardiac arrest in pigs.

Purpose: The induction of deep cerebral hypothermia (15°C) via large-volume cold (4°C) saline aortic flush during cardiac arrest and resuscitation with cardiopulmonary bypass improves neurologic outcome in pigs. We hypothesized that induction of mild cerebral hypothermia (33°C) via smaller volume and resuscitation without bypass will improve survival and neurologic outcome after 15 minutes of cardiac arrest as compared with conventional resuscitation attempts.

Basic Procedures: Twenty-four pigs (29-38 kg) underwent ventricular fibrillation cardiac arrest for 15 minutes.