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Izolda Heydenrych,1,2 Krishan M Kapoor,3,4 Koenraad De Boulle,5 Greg Goodman,6,7 Arthur Swift,8 Narendra Kumar,9 Eqram Rahman10 1Cape Town Cosmetic Dermatology Centre, Central Park on Esplanade, Century City, Cape Town, South Africa; 2Division of Dermatology, Faculty of Medicine and Health Sciences, Stellenbosch University, Stellenbosch, South Africa; 3Department of Plastic Surgery, Fortis Hospital, Mohali, India; 4AntiClock Clinic, Chandigarh, India; 5Aalst Dermatology Clinic, Aalst, Belgium; 6Department of Primary Heath Care, Monash University, Clayton, Victoria, Australia; 7Skin and Cancer Foundation Inc, Clayton, Victoria, Australia; 8Westmount Institute of Plastic Surgery, Montreal, Canada; 9Faculty of Medical Science, Anglia Ruskin University, Chelmsford, UK; 10Institute of Medical and Biomedical Education, St George’s University of London, London, UK Abstract: The recent rapid growth in dermal filler use, in conjunction with inadequate product and injector control, has heralded a concerning increase in filler complications. The 10-point plan has been developed to minimize complications through careful preconsideration of causative factors, categorized as patient, product, and procedure related. Patient-related factors include history, which involves a preprocedural consultation with careful elucidation of skin conditions, systemic disease, medications, and previous cosmetic procedures. Other exclusion criteria include autoimmune diseases and multiple allergies. The temporal proximity of dental or routine medical procedures is discouraged. Insightful patient assessment, with the consideration of ethnicity, gender, and generational needs, is of paramount importance. Specified informed consent is vital due to the concerning increase in vascular complications, which carry the risk for skin compromise and loss of vision. Informed consent should be signed for both adverse events and their treatment. Product-related factors include reversibility, which is a powerful advantage when using hyaluronic acid (HA) products. Complications from nonreversible or minimally degradable products, especially when layered over vital structures, are more difficult to control. Product characteristics such as HA concentration and proprietary cross-linking should be understood in the context of ideal depth, placement, and expected duration. Product layering over late or minimally degradable fillers is discouraged, while layering of HA of over the same brand, or even across brands, seems to be feasible. Procedural factors such as photographic documentation, procedural planning, aseptic ­technique, and anatomical and technical knowledge are of pivotal importance. A final section is dedicated to algorithms and protocols for the management and treatment of complications such as hypersensitivity, vascular events, infection, and late-onset nodules. The 10-point plan is a systematic, effective strategy aimed at reducing the risk of dermal filler complications. Keywords: assessment, complications, dermal fillers, prevention, treatment

Background: In vitro, animal, and ecological studies suggest that inadequate vitamin D intake could increase prostate cancer risk, but results of biomarker-based longitudinal studies are inconsistent. Methods: Data for this case (n = 1,731) and cohort (n = 3,203) analysis are from the Selenium and Vitamin E Cancer Prevention Trial. Cox proportional hazard models were used to test whether baseline plasma vitamin D (25-hydroxy) concentration, adjusted for season of blood collection, was associated with the risk of total and Gleason score 2-6, 7-10, and 8-10 prostate cancer. Results: There were U-shaped associations of vitamin D with total cancer risk: compared with the first quintile, HRs were 0.83 [95% confidence interval (CI), 0.66-1.03; P = 0.092], 0.74 (95% CI, 0.59-0.92; P = 0.008), 0.86 (95% CI, 0.69-1.07; P = 0.181), and 0.98 (95% CI, 0.78-1.21; P = 0.823), for the second through fifth quintiles, respectively. For Gleason 7-10 cancer, corresponding HRs were 0.63 (95% CI, 0.45-0.90; P = 0.010), 0.66 (95% CI, 0.47-0.92; P = 0.016), 0.79 (95% CI, 0.56-1.10; P = 0.165), and 0.88 (95% CI, 0.63-1.22; P = 0.436). Among African American men (n = 250 cases), higher vitamin D was associated with reduced risk of Gleason 7-10 cancer only: in the a posteriori contrast of quintiles 1-2 versus 3-5, the HR was 0.55 (95% CI, 0.31-0.97; P = 0.037), with no evidence of dose-response or a U-shaped association. Conclusions: Both low and high vitamin D concentrations were associated with increased risk of prostate cancer, and more strongly for high-grade disease. Impact: The optimal range of circulating vitamin D for prostate cancer prevention may be narrow. Supplementation of men with adequate levels may be harmful. © 2014 American Association for Cancer Research.

The Beta-Carotene and Retinol Efficacy Trial tested the effect of the combination of beta-carotene (30 mg) and retinyl palmitate (25,000 units) daily on the incidence of lung cancer in high-risk individuals. In study centers located in Seattle, WA; Portland, OR; and Irvine, CA, we recruited current and recent ex-cigarette smokers, aged 50-69 years. Our primary method of recruitment was by mailing study information and eligibility questionnaires to age-selected health insurance subscribers. A total of 1,216,549 subscriber households were contacted, which resulted in 16,449 enrollments and 12,184 randomizations. Other methods of recruitment yielded 1421 enrollments and 1002 randomizations. Seventy-four % of those participants who enrolled in the 3-month placebo run-in were randomized. The major reasons for nonrandomization once subjects were enrolled were: becoming ineligible (13%), concern about or development of side effects attributed to the study vitamins (18%), loss of interest or being too busy (23%), and not showing up at the appointed time or not willing to come to the study center (23%). Here, we discuss the reasons for nonparticipation and for subjects leaving the trial prior to randomization and possible modifications of trial design and procedures to address these problems. This recruitment approach provided a constant flow of potentially eligible participants, screened out many ineligible and uninterested persons prior to the scheduling of a study center visit, and ensured randomization of committed participants. A major limitation of this study was that the pool of minorities that was reached was small.

Lung cancer and cardiovascular disease are major causes of death in the United States. It has been proposed that carotenoids and retinoids are agents that may prevent these disorders.We conducted a multicenter, randomized, double-blind, placebo-controlled primary prevention trial -- the Beta Carotene and Retinol Efficacy Trial -- involving a total of 18,314 smokers, former smokers, and workers exposed to asbestos. The effects of a combination of 30 mg of beta carotene per day and 25,000 IU of retinol (vitamin A) in the form of retinyl palmitate per day on the primary end point, the incidence of lung cancer, were compared with those of placebo.A total of 388 new cases of lung cancer were diagnosed during the 73,135 person-years of follow-up (mean length of follow-up, 4.0 years). The active-treatment group had a relative risk of lung cancer of 1.28 (95 percent confidence interval, 1.04 to 1.57; P=0.02), as compared with the placebo group. There were no statistically significant differences in the risks of other types of cancer. In the active-treatment group, the relative risk of death from any cause was 1.17 (95 percent confidence interval, 1.03 to 1.33); of death from lung cancer, 1.46 (95 percent confidence interval, 1.07 to 2.00); and of death from cardiovascular disease, 1.26 (95 percent confidence interval, 0.99 to 1.61). On the basis of these findings, the randomized trial was stopped 21 months earlier than planned; follow-up will continue for another 5 years.After an average of four years of supplementation, the combination of beta carotene and vitamin A had no benefit and may have had an adverse effect on the incidence of lung cancer and on the risk of death from lung cancer, cardiovascular disease, and any cause in smokers and workers exposed to asbestos.

CARET is a multicenter, two-armed, double-masked randomized chemoprevention trial in Seattle, Portland, San Francisco, Baltimore, Connecticut, and Irvine, to test whether oral administration of beta-carotene (30 mg/day) plus retinyl palmitate (25,000 IU/day) can decrease the incidence of lung cancer in high risk populations, namely, heavy smokers and asbestos-exposed workers. The intervention combines the antioxidant action of beta-carotene and the tumor suppressor mechanism of vitamin A. As of April 30, 1993, CARET had randomized 1,845 participants in the 1985-1988 pilot phase plus 13,260 "efficacy" participants since 1989; of these, 4,000 are asbestos-exposed males and 11,105 are smokers and former smokers (44% female). Accrual is complete everywhere except Irvine, which was the last center added (1991), and the safety profile of the regimen to date has been excellent. With 14,420 smokers, 4,010 asbestos-exposed participants, and 114,100 person-years through February 1998, we expect CARET to be capable of detecting a 23% reduction in lung cancer incidence in the two populations combined and 27, 49, 32, and 35% reductions in the smokers, female smokers, male smokers, and asbestos-exposed subgroups, respectively. CARET is highly complementary to the alpha-tocopherol-beta-carotene study in Finland and the Harvard Physicians Health Study (beta-carotene alone) in the National Cancer Institute portfolio of major cancer chemoprevention trials.

Background: Pre-exposure prophylaxis (PrEP) is a potent biomedica tool for HIV prevention; however, PrEP is underutilized among African American (AA) women in the Deep South of the United States, despite [...]

Background: HPTN083, a randomized, double-blind international clinical trial of long-acting injectable cabotegravir (CAB-LA) versus daily oral emtricitabine/tenofovir disoproxil fumarate (TDF/FTC) for HIV prevention among cisgender men and transgender women who [...]