Practical considerations of promising zone design for interim sample size Re-estimation: An application to GRAPHITE for graft vs host disease.

Background: Sample size calculation and power estimate are an integral part of clinical trials. With accelerated development to address the unmet medical needs, the fast-paced development may lead to uncertainties in initial planning and assumptions of clinical trials. Promising zone design presents sponsors an opportunity to re-estimate the sample size based on the interim data to mitigate risks, reduce uncertainties, and increase probability of trial success.

Binary classification of users of electronic cigarettes and smokeless tobacco through biomarkers to assess similarity with current and former smokers: machine learning applied to the population assessment of tobacco and health study.

Background: Exposure to harmful and potentially harmful constituents in cigarette smoke is a risk factor for cardiovascular and respiratory diseases. Tobacco products that could reduce exposure to these constituents have been developed. However, the long-term effects of their use on health remain unclear.

Randomized clinical trial: A double-blind, proof-of-concept, phase 2 study evaluating the efficacy and safety of vonoprazan 20 or 40 mg versus esomeprazole 40 mg in patients with symptomatic gastro-esophageal reflux disease and partial response to a healing dose of a proton-pump inhibitor.

Background: Proton-pump inhibitors (PPIs) are cornerstone treatments for gastro-esophageal reflux disease (GERD); however, evidence suggests that most patients exhibit partial response to PPIs, suggesting the need for novel therapies that can provide an improved and sustained increase in gastric pH.

Aims: This study aimed to determine the effect of vonoprazan, a novel, orally active small-molecule potassium-competitive acid blocker, versus esomeprazole, a PPI, in preventing heartburn symptoms over a 4-week treatment period in patients with GERD and a partial response to esomeprazole treatment.

Methods: This randomized, double-blind, proof-of-concept, phase 2 clinical trial was conducted between 2016 and 2018 at 39 sites across Europe and designed to evaluate the efficacy and safety of vonoprazan 20 mg once daily (q.

Impact of red blood cell distribution width and mean platelet volume in patients with ST-segment elevation myocardial infarction.

The complete blood cell count is one of the most frequently ordered laboratory tests, and many parameters, including red blood cell distribution width (RDW) and mean platelet volume (MPV), are available. The purpose of this study was to investigate the usefulness of the combination of RDW and MPV in patients with ST-segment elevation myocardial infarction (STEMI). Patients with STEMI who underwent primary percutaneous coronary intervention were retrospectively enrolled (n = 229).

Evaluation of safety and pharmacokinetics of bismuth-containing quadruple therapy with either vonoprazan or lansoprazole for Helicobacter pylori eradication.

Aims: Helicobacter pylori (Hp) eradication plays a key role in the treatment and prevention of peptic ulcer diseases. Increasing clarithromycin resistance in Hp necessitates more effective treatments for eradication, such as bismuth-containing quadruple therapy. We aimed to compare the safety and pharmacokinetics (PK) of bismuth between vonoprazan- and lansoprazole-containing quadruple therapy in Hp-positive subjects.