Clinical trials are interventional studies on human beings, designed to test the hypothesis for diagnostic techniques, treatments, and disease preventions. Any novel medical technology should be evaluated for its efficacy and safety by clinical trials. The costs associated with developing drugs have increased dramatically over the past decade, and fewer drugs are obtaining regulatory approval. Because of this, the pharmaceutical industry is continually exploring new ways of improving drug developments, and one area of focus is adaptive clinical trial designs. Adaptive designs, which allow for some types of prospectively planned mid-study changes, can improve the efficiency of a trial and maximize the chance of success without undermining validity and integrity of the trial. However it is felt that in adaptive trials; perhaps by using accrued data the actual patient population after the adaptations could deviate from the originally target patient population and so to overcome this drawback; special methods like Bayesian Statistics, predicted probability are used to deduce data-analysis. Here, in this study, mathematical model of a new adaptive design (shuffling adaptive trial) is suggested which uses real-time data, and because there is no gap between expected and observed data, statistical modifications are not needed. Results are obviously clinically relevant.

Since the invention of electrocardiogram (ECG or EKG), its significance in the diagnosis of acute ischemic disease, chronic ischemic disease, and its contribution to cardiology has been no less than remarkable. The pathophysiology of acute coronary syndromes in most cases correlates with the clinical outcomes, biochemical findings (cardiac biomarkers), and electrocardiographic patterns. Electric activity in the myocardium is registered in the ECG describing positive deflections when the depolarization potential orientates positive charges to the recording electrode (approaches to it) and negative deflections when the depolarization potential orientates negative charges to the recording electrode and gets away from it. The abnormal Q-wave is the cornerstone of the myocardial infarction diagnosis after several days of the ischemic event. Findings in the ECG suggestive of ischemia and necrosis are ST elevation/depression and deep Q-waves, respectively, and the presence of a deep abnormal Q-wave in the ECG is evidence of necrotic areas and an inert myocardium, which is not capable to depolarize. Non-Q-wave myocardial infarction has been defined as acute myocardial infarction without a new-onset deep Q-wave on the ECG after day(s) of evolution, and because of the anatomopathological concept of infarction is usually related to necrosis, it results paradoxical to consider this widely known clinical and biochemical entity as a myocardial infarction when there is no evidence of necrosis in the ECG.

Pasteurella multocida (PM) is gram-negative coccobacillus that is commonly acquired through a cat scratch or bite. The standard antibiotic of choice for treating PM is penicillin. We present a case of PM empyema in a penicillin allergic 56-year-old female who has a history of contact with domestic cats and is known to have chronic obstructive pulmonary disease and a chronic history of smoking. The patient was treated successfully with Levofloxacin as alternative treatment to penicillin.

The incidence of ventilator-associated pneumonia (VAP) is particularly high in trauma patients. Immediate acute inflammation response is one of the hallmarks of multiple trauma. This phenomenon is associated with an immunosuppression state and may increase the risk of VAP. In our study, we aimed to evaluate whether low-dose steroids prevent VAP onset in multiple trauma patients. All adult patients admitted in our intensive care unit (ICU) for multiple trauma with predicted duration of mechanical ventilation over 48 hours were included. We compared 2 different periods: a retrospective cohort of patients who did not receive low-dose steroids for VAP prevention and a prospective cohort of patients who received hydrocortisone with a dose of 100 mg/8 hours for a scheduled period of 7 days. We included 175 patients: 92 in the steroids (-) group and 83 in the steroids (+) group. The incidence of VAP was not different between the 2 studied groups (29.3% and 26.5%; P = 0.676). When predictive factors of VAP onset were studied in multivariate analysis, steroids had no preventive effect on VAP [OR = 1.6; 95% confidence interval, 0.73-3.6; P = 0.234]. We did not find any difference between the 2 groups, neither in terms of ICU length of stay (respectively, 11 ± 9.7 days vs. 12.3 ± 10.7 days; P = 0.372) nor in terms of ICU mortality (29.3% vs 24.1%; P = 0.434).

Valsartan is known to inhibit platelet activity in both in vitro and ex vivo clinical setting, whereas aliskiren in vitro modulates antithrombin-III in plasma. The authors tested how aliskiren and valsartan combination versus aliskiren monotherapy will affect hemostatic biomarkers in mild-to-moderate hypertensive diabetics in the frame of the Aliskiren and Valsartan Impact in Diabetics (AVID) trial. A total of 52 patients with type 2 diabetes and mild-to-moderate hypertension were equally randomized to aliskiren (150-300 mg/d) and valsartan (160 mg/d) versus aliskiren (150-300 mg/d) alone for 4 weeks. A total of 25 biomarkers were serially measured, of which 16 are related to platelet function, 6 to coagulation, and 3 to fibrinolysis. Aliskiren monotherapy has no significant impact on any of the assessed biomarkers. In contrast, valsartan on top of aliskiren provided significant inhibition of ADP-induced platelet aggregation (P = 0.032), decreased shear-induced activation measured with PFA-100 analyzer (P = 0.041), and diminished expression of GP IIb/IIIa activity (P = 0.027) measured by PAC-1 antibody, GP Ib (CD42b, P = 0.033), vitronectin receptor (CD51/61, P = 0.046), P-selectin (CD62p, P = 0.026), lysosome-associated membrane protein (CD107a, P = 0.042), and CD40-ligand (CD154, P = 0.048). In AVID trial, valsartan in combination with aliskiren mildly but significantly inhibited platelets, confirming previous observations. In contrast, aliskiren monotherapy does not enhance antithrombin activity, suggesting that previous data probably represent a laboratory artifact. Importantly, these randomized data were generated on top of low-dose daily aspirin, supporting extra benefit for combination use of angiotensin receptor blockers and renin inhibitors in high-risk diabetic population.

Bupropion is a norepinephrine dopamine-reuptake inhibitor that has been found to be effective in the treatment of nicotine dependence. Although well tolerated, seizures and psychosis have been described to occur with bupropion as severe adverse effects. We report the precipitation of acute psychosis with bupropion prescribed for smoking cessation in an elderly patient.

Ziprasidone is a second-generation antipsychotic with a lower propensity to cause extrapyramidal adverse effects that are seen at higher doses. We report a patient who developed acute dystonia, parkinsonism, and severe akathisia with ziprasidone 80 mg/d. These adverse effects subsided after dose reduction and specific treatment for akathisia and parkinsonism.