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Advancing nanomedicines from concept to clinic requires integration of new science with traditional pharmaceutical development. The medical and commercial success of nanomedicines is greatly facilitated when those charged with developing nanomedicines are cognizant of the unique opportunities and technical challenges that these products present. These individuals must also be knowledgeable about the processes of clinical and product development, including regulatory considerations, to maximize the odds for successful product registration. This article outlines these topics with a goal to accelerate the combination of academic innovation with collaborative industrial scientists who understand pharmaceutical development and regulatory approval requirements—only together can they realize the full potential of nanomedicines for patients.  相似文献   
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Purpose

The purpose of this study was to evaluate trends in demographics and outcomes of pediatric breast cancer in a United States population-based cohort.

Methods

The Surveillance, Epidemiology, and End Results (SEER) database was utilized to identify all pediatric patients with malignant breast tumors between 1973 and 2014. Analysis was performed using Stata Statistical Software version 13.1. Associations between categorical variables were made using X2 test. Log-rank test was used for univariate survival analysis. Kaplan–Meier analysis investigated five-year survival rates across several variables. Adjusted analysis was performed using a Cox Proportional-Hazards regression.

Results

134 patients with breast malignancies were identified. Carcinoma was the most prevalent histology (48.5%), followed by fibroepithelial tumors (FETs) (35.1%), and sarcoma (14.2%). FETs were twice as common in black compared to nonblack patients (56.3% vs. 29.0%, p?<?0.01). Analyzing histology by stage revealed that 100% of FETs were early stage disease (p?<?0.0001). 46.7% of the tumors tested were ER/PR negative, more than twice as many compared to the published adult estimate of 20.0%. Unadjusted survival analysis revealed worse survival for patients with adenocarcinoma/sarcomas, advanced stage, and high grade disease, without a survival difference between races.

Conclusion

Breast cancer remains a rare malignancy among pediatric patients. Although black patients were found to have more noncarcinomatous tumors with less advanced disease, this did not confer a survival advantage.

Type of study

Retrospective cohort study.

Level of evidence

Level III.  相似文献   
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Background. It has been reported that gender differences in cardiovascular outcomes found in adults also are present in children who undergo surgical repair for congenital heart disease. Methods. California statewide hospital discharge data 1989–99 were used to study outcomes in children <18 years undergoing cardiac surgery. Hospital discharge data were linked to death registry data to study postdischarge death within 30 days of discharge. We used logistic regression to evaluate the effect of gender on mortality controlling for age, race and ethnicity, type of insurance, household income, date and month of surgery, type of admission, hospital case volume, and various types of procedures. Results. There were 25 402 cardiac surgery cases with 1505 in‐hospital deaths (mortality rate of 5.92%). An additional 37 deaths occurred within 30 days after hospital discharge. Crude mortality rates for males (5.99%) and females (5.84%) were not significantly different. However, fewer neonates were female and females underwent a higher proportion of low‐risk procedures than males. Logistic regression revealed that females, compared with males, had a significantly higher odds ratio (OR) for in‐hospital mortality (OR = 1.18, P < .01) and overall (up to 30 days post discharge) mortality (OR = 1.18, P < .01). The risk‐adjusted length of hospital stay was similar between females and males while charges per hospital day were slightly higher in females than males. The prevalence of Down syndrome, pulmonary hypertension, and failure to thrive were higher in females. Conclusions. Female gender is associated with an 18% higher in‐hospital and 30‐day postdischarge mortality as compared with male gender. There was no difference in length of hospital stay between males and females. The mechanism by which female gender acts as a risk factor requires further investigation.  相似文献   
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Acute effects of cypermethrin, a pesticide used to treat ectoparasite infestations of salmon, were assessed using the calanoid copepod Acartia tonsa. A. tonsa has been widely used for hazard assessment of chemicals in the marine environment using acute toxicity tests, but only with randomly selected adults, assuming a sex ratio of 1:1. The present study assesses the environmental hazard of cypermethrin by exposing nauplii and adult males and females, separately. Our results showed that the naupliar stages were 28 times more sensitive to cypermethrin than adults after 96 h of exposure, with LC50s of 0.005 μg L−1 and 0.142 μg L−1, respectively. Significant differences in sensitivity between sexes were only found during the first 24 h of exposure, with males being approximately twice as sensitive as females. The results of age-related variation in sensitivity are supported by studies with other species of copepods and toxicants, where the increased capacity of the adults for detoxification, the allometric differences in weight and size, and the molting process are given as explanations. Variation in sensitivity between sexes is discussed in terms of faster depuration rates in females through egg production and implications of feeding rate changes after 24 h of exposure. Our results suggested that standard toxicity test methods using A. tonsa are unsatisfactory because the most sensitive life stage is not included and sex-related differences in tolerance are not taken into account. We also found that cypermethrin caused significant mortality in Acartia at exposures concentrations from one to three orders of magnitudes lower than the recommended field treatment concentration for copepodic infestations. Received: 27 April 2001/Accepted: 1 July 2001  相似文献   
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The 8th Conference of the British Psychosocial Oncology Group was held in London on 9–10 December 1991 and attracted over 120 participants. The conference was extended from its usual one day format to one and a half days, to allow more time for both a formal and informal exchange of ideas. Eight invited speakers participated, but proferred papers and posters remained an important focus of the meeting. This is the largest annual conference in Britain for professionals working in psychosocial oncology and an important forum for the presentation of research. As in previous years, the conference attracted a number of newcomers, indicating the continued expansion of this field of research. A number of topical issues were presented in keynote papers by invited speakers. New work in cancer prevention and the associated areas of counselling families at risk and ethical issues, formed one symposium. Communication skills and relevant training needs in paediatric and adult oncology were an important theme of the conference and intervention studies formed the third main topic.  相似文献   
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