Regulatory agencies such as the US Food and Drug Administration and health technology assessment bodies are increasingly using real-world evidence (RWE). The ability of healthcare systems to reliably generate response rate and progression-free survival from real-world data is unknown. We examined the capacity of a single-payer system to provide RWE by evaluating the frequency of computed tomography (CT) imaging during standard first-line metastatic systemic treatment of breast, colorectal, and lung cancer.
 
  A 1-year cohort of patients with metastatic-at-diagnosis breast, colorectal, and lung cancer treated with first-line systemic therapy (excluding hormone therapy) referred to BC Cancer in 2016 was retrospectively reviewed for first-line treatment and CT imaging. Duration of first-line treatment was calculated from the first to the last dose of therapy. CT imaging was counted from the start of therapy to 8 weeks after the last therapy dose.
 
  A cohort of 664 patients was identified from the BC Cancer Regiiding RWE for image-based end points. Alternative end points should be considered to capitalize on the wealth of real-world data.Background Although most women start breastfeeding after delivery, difficulties often arise. One of the main reasons is nipple soreness, which contributes greatly to early cessation of breastfeeding. A soreness evaluation through validated scales, performed by health care professionals during the first few days, can contribute to improve breastfeeding and support for the mothers. Research Aim Knowing the prevalence of nipple soreness during breastfeeding at 48 hours postpartum at the Infanta Cristina University Hospital (Madrid, Spain) through a cross-sectional descriptive study. Materials and Methods The study took place between February and March 2019. A survey of 58 postpartum second day mothers was conducted including the Visual Analogue Scale (VAS) and Lactation Assessment Scale (LATCH) score for breastfeeding assessment. A descriptive analysis of secondary variables and subsequent bivariate inferential was performed for 95% confidence interval (CI). Results The prevalence of nipple soreness observed is 97% (95% CI = 92-100%). It was found, significantly (p = 0.001), that the higher the score on LATCH, the lower the score on VAS and therefore the less pain. We found a relationship between women who were in skin-to-skin contact with their babies for 2 hours without interruption after birth and a higher pain score (p = 0.046). No other associations were found between VAS and other variables such as parity, type of birth, artificial milk supplements for the newborn, or using a pacifier. Conclusions The high percentage of nipple soreness detected highlights that breastfeeding can be unpleasant in the first days after delivery. It is important to include in clinical practice the assessment of nipple soreness and the effectiveness of breastfeeding using validated scales.
  Adoption of prognostic molecular assays for prostate cancer requires evidence of robust performance in different racial groups. Retrospective analysis was conducted to assess the performance of the Oncotype DX
  Genomic Prostate Score
  test in African American and Caucasian American men with surgically treated prostate cancer.
 
  We compared the assay results (scale 0-100) and the 4 gene group scores in biopsy specimens from 201 African American and 1,144 Caucasian American men with clinically localized prostate cancer in 6 cohorts. Adverse pathology was defined as high grade (primary Gleason pattern 4 or any pattern 5) and/or nonorgan-confined disease (≥pT3). Binary logistic regression models were used for adverse pathology. Biochemical recurrence was defined as 2 successive prostate specific antigen levels >0.2 ng/ml or initiation of salvage therapy after radical prostatectomy. Cox proportional hazards models evaluated the association of the assay result or racial group with time to biochemical recurrence.
 
  Each cohort had different clinical risk distributions and percentages of African Americans, although median and interquartile ranges of the assay results and gene group scores were similar between both racial groups. In a multivariable model with the assay and pathological/clinical features including race, the assay was significantly associated with adverse pathology (p ≤0.004) and biochemical recurrence (p <0.001). Race was not a significant predictor of either end point.
 
  The assay is similarly predictive of outcomes in African American and Caucasian American patients, and improves risk stratification in men with newly diagnosed prostate cancer from both racial groups.
 The assay is similarly predictive of outcomes in African American and Caucasian American patients, and improves risk stratification in men with newly diagnosed prostate cancer from both racial groups.Amorphization is a well-established strategy to enhance the dissolution properties of poorly water-soluble drugs. However, the amorphous state is inherently unstable toward recrystallization. Coamorphous systems of a drug and a small-molecule excipient or of two complementary drugs often show an enhanced stability. Diabetes and hypertension are frequently coexistent. In this paper a study on the coamorphization of the poorly water-soluble antidiabetic drug gliclazide (glz) and the antihypertensive drug valsartan (val) is reported. Amorphous glz recrystallized after 1 d under ambient conditions, whereas coamorphous glz-val containing glz and val in a 11 or 12 molar ratio was stable for at least four months at 20 °C and 56% relative humidity. The dissolution rate of glz increased in the order crystalline glz  less then  glz-val_11  less then  glz-val_12.  https://www.selleckchem.com/products/ziritaxestat.html  Furthermore, ternary coamorphous systems of glz, val and an excipient were prepared; glz-val_11_PVP, glz-val_11_HPC, glz-val_11_ALM, glz-val_11_MCC (PVP = polyvinylpyrrolidone, HPC = hydroxypropyl cellulose, ALM = α-lactose monohydrate, MCC = microcrystalline cellulose). MCC and HPC did not affect the stability of the coamorphous system, while ALM promoted the recrystallization of glz in glz-val_11_ALM during storage and freshly prepared glz-val_11_PVP contained small amounts of crystalline glz. Glz-val_11_MCC showed enhanced dissolution properties compared to crystalline glz and glz-val_11 and is a viable fixed-dose formulation.