001), general fatigue (p=0.009), physical fatigue (p=0.001), reduce activity (p=0.001), and mental fatigue (p=0.014) higher than that of pregabalin. No difference in (GCI) was seen at six weeks.
 
  This is the first trial aimed at comparing gabapentin with pregabalin in NLBP. Although the results are preliminary, in our pilot study pregabalin was found to be superior in pain reduction, gabapentin demonstrated better effect on anxiety, insomnia and fatigue symptoms. The results are preliminary, studies with a larger sample size are still required.
 This is the first trial aimed at comparing gabapentin with pregabalin in NLBP. Although the results are preliminary, in our pilot study pregabalin was found to be superior in pain reduction, gabapentin demonstrated better effect on anxiety, insomnia and fatigue symptoms. The results are preliminary, studies with a larger sample size are still required.
  Phase 1 studies comprise the first exposure of a promising new chemical entity in healthy volunteers or, when appropriate, in patients. To assure a solid foundation for subsequent drug development, this first step must carefully assess the safety and tolerance of a new compound, and often provide some indication of potential effect, so that a safe dose or dose range can be confidently selected for the initial Phase 2 efficacy study in the target patient population.
 
  This review was based on a literature search using both Google Scholar and PubMed, dated back to 1970, using search terms including "healthy volunteers", "Phase 1", and "normal volunteers" , and also based on the authors' own experience conducting Phase 1 clinical trials. This paper reviews the history of Phase 1 studies of small molecules and their rapid evolution, focusing on the critical single and multiple dose studies, their designs, methodology, use of pharmacokinetic and pharmacodynamic modeling, application of potentially helpful biomar for drug developers and study investigators alike, but which can crucially determine whether a compound can survive to the next step in the drug development process.
 Phase 1 studies can yield critical insights to the pharmacology of a new compound in man and offer perhaps the only development period in which the dose range can be safely and thoroughly explored. Phase 1 studies often contain multiple endpoint objectives, the reconciliation of which can present a dilemma for drug developers and study investigators alike, but which can crucially determine whether a compound can survive to the next step in the drug development process.
  Leaks are the major complication associated with laparoscopic sleeve gastrectomy.
 
  To assess the efficacy and safety of specifically designed large covered metal stents for the management post-laparoscopic sleeve gastrectomy leaks.
 
  Prospectively collected databases from three Italian Endoscopy Units were reviewed. The primary outcome of the study was to evaluate the clinical success of stents placement, defined as complete resolution of clinical and laboratory signs of sepsis with radiological evidence of leak closure. Secondary outcomes were stent-related adverse events and mortality.
 
  Twenty-one patients (67% females, mean age 45 years) were included in the study and a total of 26 stents were placed.  https://www.selleckchem.com/products/cetuximab.html  Technical success of stent placement was achieved in all cases (100%). Clinical success was observed in 85.5% of patients. Stent related adverse events occurred in 9 patients (43%), with stent migration as most frequent complication (33%). Adverse events were more frequently observed in patients who had undergone bariatric surgery prior to laparoscopic sleeve gastrectomy compared to patients without previous surgery (83% vs 27%, p=0.018).
 
  Placement of specifically designed covered metal stents appears to be an effective and safe therapeutic approach for post-laparoscopic sleeve gastrectomy leaks. Stent migration can be a frequent complication.
 Placement of specifically designed covered metal stents appears to be an effective and safe therapeutic approach for post-laparoscopic sleeve gastrectomy leaks. Stent migration can be a frequent complication.Red cell distribution width (RDW) serves as an independent predictor towards the prognosis of coronary artery disease (CAD) in patients undergoing percutaneous coronary intervention (PCI). A systematic search of databases such as PubMed, Embase, Web of Science, and Cochrane library was performed on October 10th, 2019 to elaborate the relationship between RDW and in hospital and long term follow up all-cause and cardiovascular mortality, major adverse cardiac events (MACE) and development of contrast-induced nephropathy (CIN) in patients with CAD undergoing PCI. Twenty-one studies qualified this strict selection criteria (number of patients = 56,425) one study was prospective, and the rest were retrospective cohorts. Our analysis showed that patients undergoing PCI with high RDW had a significantly higher risk of in-hospital all-cause mortality (OR 2.41), long-term all-cause mortality (OR 2.44), cardiac mortality (OR 2.65), MACE (OR 2.16) and odds of developing CIN (OR 1.42) when compared to the patients with low RDW. Therefore, incorporating RDW in the predictive models for the development of CIN, MACE, and mortality can help in triage to improve the outcomes in coronary artery disease patients who undergo PCI.Exosomes as one of the extracellular vesicles' subgroups played an important role in the cell to cell communication. The cargos and surface protein of exosomes have been known to affect the cardiovascular system both positively and negatively in chronic heart failure, ischemic heart disease, and atherosclerosis. There have been several exosomes that emerged as a potential diagnostic and prognostic marker in cardiovascular patients. However, the conditions affecting the patients and the method of isolation should be considered to create a standardized normal value of the exosomes and the components. CPC-derived exosomes, ADSCs-derived exosomes, and telocyte-derived exosomes have been proven to be capable ofacting as a therapeutic agent in myocardial infarction models. Exosomes have the potential to become a diagnostic marker, prognostic marker, and therapeutic agent in cardiovascular diseases.