Clinical Safety-in-Use Study of a New Tampon Design

Objective: To confirm the safety of a new experimental Tampax(®) tampon and applicator compared with that of a currently marketed Tampax(®) tampon and applicator using comprehensive gynecological and microbiological assessments. Methods: A 2-month, single-blind, randomized, crossover study was conducted in which each subject served as her own control. Safety was evaluated by comparing potential product-related irritation (using colposcopic examination and subject diary data), assessment of vaginal discharge, vaginal pH, and effects on selected microorganisms (yeast, Escherichia coli ,Staphylococcus aureus and group B streptococci) obtained by vaginal swab cultures after normal menstrual use in the experimental and control groups. Results: In total, 110 women completed the study. There were no significant differences between the groups that used either the experimental or control tampon with regard to prevalence or mean cell density for the selected microorganisms. No differences were observed in the incidence or severity of erythema, in abrasion or ulceration of the cervix, vagina, introitus, vulva or perineum, or in mean vaginal pH and discharge assessments. There were equivalent low incidences of reported symptoms such as discomfort during insertion, wear or removal, and a similar low incidence of burning, stinging or itching during use of either the control or experimental tampon. There was a more favorable overall product rating for the experimental tampon (p = 0.003). Conclusions: This approach provides a combination of gynecological, microbiological and self-reported (diary recall) methodologies in order to assess tampon safety during use more thoroughly than has previously been reported, and it supports a comparable safety profile for the experimental tampon and a currently marketed tampon

Significant benefits of AIP testing and clinical screening in familial isolated and young-onset pituitary tumors

Context Germline mutations in the aryl hydrocarbon receptor-interacting protein (AIP) gene are responsible for a subset of familial isolated pituitary adenoma (FIPA) cases and sporadic pituitary neuroendocrine tumors (PitNETs). Objective To compare prospectively diagnosed AIP mutation-positive (AIPmut) PitNET patients with clinically presenting patients and to compare the clinical characteristics of AIPmut and AIPneg PitNET patients. Design 12-year prospective, observational study. Participants & Setting We studied probands and family members of FIPA kindreds and sporadic patients with disease onset ≤18 years or macroadenomas with onset ≤30 years (n = 1477). This was a collaborative study conducted at referral centers for pituitary diseases. Interventions & Outcome AIP testing and clinical screening for pituitary disease. Comparison of characteristics of prospectively diagnosed (n = 22) vs clinically presenting AIPmut PitNET patients (n = 145), and AIPmut (n = 167) vs AIPneg PitNET patients (n = 1310). Results Prospectively diagnosed AIPmut PitNET patients had smaller lesions with less suprasellar extension or cavernous sinus invasion and required fewer treatments with fewer operations and no radiotherapy compared with clinically presenting cases; there were fewer cases with active disease and hypopituitarism at last follow-up. When comparing AIPmut and AIPneg cases, AIPmut patients were more often males, younger, more often had GH excess, pituitary apoplexy, suprasellar extension, and more patients required multimodal therapy, including radiotherapy. AIPmut patients (n = 136) with GH excess were taller than AIPneg counterparts (n = 650). Conclusions Prospectively diagnosed AIPmut patients show better outcomes than clinically presenting cases, demonstrating the benefits of genetic and clinical screening. AIP-related pituitary disease has a wide spectrum ranging from aggressively growing lesions to stable or indolent disease course

Efeito higrotérmico em prepregs de fibra de vidro/epóxi por espectroscopia de luminescência Hygrothermal effect in glass fiber/epoxy by luminescence spectroscopy

O objetivo deste trabalho é o estudo do efeito higrotérmico em pré-impregnados (prepreg) não curados de fibra de vidro-resina epoxídica usando a técnica de espectroscopia eletrônica de luminescência em modo estacionário. O método de fluorescência extrínseca foi empregado utilizando-se a sonda 9- ácido antróico (9-AA), cujo comportamento fotofísico depende fortemente da polaridade do meio. As amostras foram submetidas a umidades relativas de 6 e 84% por meio da utilização de soluções aquosas saturadas de hidróxido de sódio a 34,5 &deg;C e cloreto de potássio a 20,0 &deg;C, em recipientes fechados, pelos períodos de tempo de 1 semana, 15 dias e 1 mês. As amostras submetidas à umidade relativa de 6% apresentaram aumento significativo das intensidades relativas dos espectros de fluorescência em relação à amostra referência. Este comportamento fotofísico foi atribuído à presença da forma protonada do 9-AA no meio devido à reticulação da matriz polimérica. Após 1 mês, o espectro de emissão apresenta uma diminuição da intensidade em seu máximo. Isto ocorreu provavelmente devido ao processo de plastificação da matriz polimérica promovido pela presença de água na matriz, confirmado pela análise gravimétrica. Os espectros de fluorescência extrínseca das amostras submetidas à umidade relativa de 84% apresentaram as seguintes modificações espectrais: a) decaimento da intensidade de emissão das curvas b e d; b) deslocamento da banda de emissão para a região do azul devido ao aumento do teor de água; e c) aparecimento de um ombro na banda de emissão em 424 e 472 nm. Este comportamento fotofísico foi atribuído ao deslocamento do equilíbrio químico da forma protonada para a forma ionizada do 9-AA, promovido pela entrada de umidade no material.<br>The work is aimed at studying hygrothermal effects on uncured glass-epoxy fiber prepreg (F-161 - Hexcel Co.) using luminescence spectroscopy under steady-state conditions. The fluorescence extrinsic method was employed using the 9-anthroic acid probe, whose photophysical behavior is strongly dependent on the polarity of the medium. The samples were submitted to relative humidity of 6 and 84% using saturated aqueous solutions of NaOH at 34.5 &deg;C and KCl at 20.0 &deg;C in closed recipients, for periods of time of 1 week, 15 days and 1 month. The samples submitted to the relative humidity of 6% showed a significant increase in the relative intensity of the fluorescence spectra in relation to the reference sample. This photophysical behavior was attributed to the 9-AA protonated form in the medium due to the polymeric matrix cross-linking process. After 1 month, the emission spectrum showed a decreased maximum intensity, which could be related to the polymeric matrix plasticization caused by water absorption, which was confirmed by gravimetric analysis. The extrinsic fluorescence spectra of the samples submitted to relative humidity of 84% showed the following spectral modifications: a) emission intensity decrease in curves b and d; b) blue shift in the emission band due to the humidity content; e c) appearance of a shoulder in the emission band at 424 and 472 nm. This photophysical behavior was attributed to the chemical equilibrium between protonated and ionized forms of 9-AA in the medium, promoted by absorption of water in the material