15 research outputs found

    Evidence-Based Medicine and Biostatistics

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    Interaction and Confounding in Clinical Trials.

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    Meningioma Cell Invasion into DuraGen-Derived Dura Mater: A Case Report

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    Background: Dura mater infiltration is the main growth pattern of meningiomas. Local recurrence may occur in any type of meningioma, but it is more likely so in atypical meningiomas. Therefore, a wide resection of tumor cell-invaded dura mater is necessary to avoid recurrence. DuraGen® (an artificial dural substitute) can be used for dural reconstruction in meningiomas. Here, we report a rare case of a patient with atypical meningioma that invaded into the DuraGen®-derived mature dura mater. Case presentation: A 66-year-old female showed a three-time recurrence of atypical meningioma. Simpson grade I resection (en bloc tumor with autologous dura mater and DuraGen®-derived dura mater resection) was achieved at the 3rd recurrence. Collagen fibers running regularly and transversely were observed in the DuraGen®-derived dura mater resembling the autologous meningeal layer. Meningioma cell invasion, displayed by occasional EMA immunostaining, was observed in the DuraGen®-derived dura mater. Conclusions: This case indicates that meningioma cells may invade and survive in the DuraGen®-derived dura mater. Whether or not DuraGen® is not appropriate as a dural substitute remains unanswered. Further experiences are needed to validate these findings in large sample sizes

    Effects of long-term androgen replacement therapy on the physical and mental statuses of aging males with late-onset hypogonadism: a multicenter randomized controlled trial in Japan (EARTH Study)

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    Androgen replacement therapy (ART) efficacy on late-onset hypogonadism (LOH) has been widely investigated in Western countries; however, it remains controversial whether ART can improve health and prolong active lifestyles. We prospectively assessed long-term ART effects on the physical and mental statuses of aging men with LOH in Japan. The primary endpoint was health-related quality of life assessed by questionnaires. Secondary endpoints included glycemic control, lipid parameters, blood pressure, waist circumference, body composition, muscular strength, International Prostate Symptom Scores (IPSS), International Index of Erectile Function-5 (IIEF-5) scores, and serum prostate-specific antigen levels. Of the 1637 eligible volunteers, 334 patients > 40 years with LOH were randomly assigned to either the ART (n = 169) or control groups (n = 165). Fifty-two weeks after the initial treatment, ART significantly affected the role physical subdomain of the short form-36 health survey (SF-36) scale (P = 0.0318). ART was also associated with significant decreases in waist circumstance (P = 0.002) and serum triglyceride (TG) (P = 0.013) and with significant increases in whole-body and leg muscle mass volumes (P = 0.071 and 0.0108, respectively), serum hemoglobin (P < 0.001), IPSS voiding subscore (P = 0.0418), and the second question on IIEF-5 (P = 0.0049). There was no significant difference between the groups in terms of severe adverse events. In conclusion, in patients with LOH, long-term ART exerted beneficial effects on Role Physical subdomain of the SF-36 scale, serum TG, waist circumstance, muscle mass volume, voiding subscore of IPSS, and the second question of IIEF-5. We hope our study will contribute to the future development of this area
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