Articles: nodular-goiter.
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Randomized Controlled Trial
A phase I/IIa double blind single institute trial of low dose sirolimus for Pendred syndrome/DFNB4.
Pendred syndrome (PDS)/DFNB 4 is a disorder with fluctuating and progressive hearing loss, vertigo, and thyroid goiter. We identified pathophysiology of a neurodegenerative disorder in PDS patient derived cochlear cells that were induced via induced pluripotent stem cells and found sirolimus, an mTOR inhibitor, as an inhibitor of cell death with the minimum effective concentration less than 1/10 of the approved dose for other diseases. Given that there is no rational standard therapy for PDS, we planned a study to examine effects of low dose oral administration of sirolimus for the fluctuating and progressive hearing loss, and the balance disorder of PDS by daily monitor of their audio-vestibular symptoms. ⋯ This is a phase I/IIa double blind parallel-group single institute trial in patient with PDS/DFNB4. Sixteen of outpatients with fluctuating hearing diagnosed as PDS in SLC26A4 genetic testing aged in between 7 and 50 years old at the time of consent are given either placebo or sirolimus tablet (NPC-12T). In NPC-12T placebo arm, placebo will be given for 36 weeks; in active substance arm, placebo will be given for 12 weeks and the NPC-12T for 24 weeks. Primary endpoints are safety and tolerability. The number of occurrences and types of adverse events and of side effects will be sorted by clinical symptoms and by abnormal change of clinical test results. A 2-sided 95% confidence interval of the incidence rate by respective dosing arms will be calculated using the Clopper-Pearson method. Clinical effects on audio-vestibular tests performed daily and precise physiological test at each visit will also be examined as secondary and expiratory endpoints.
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Randomized Controlled Trial Multicenter Study Comparative Study
A randomized trial of hemithyroidectomy versus Dunhill for the surgical management of asymmetrical multinodular goiter.
To assess the immediate and long-term clinical results of 2 different surgical procedures for the treatment of asymmetrical multinodular goiter (AMG). ⋯ DUN appears superior to HMT for the treatment of AMG in terms of early reoperation for missed carcinomas and disease progression. Both procedures have a similarly uneventful postoperative course.
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Randomized Controlled Trial
LigaSure vs clamp-and-tie technique to achieve hemostasis in total thyroidectomy for benign multinodular goiter: a prospective randomized study.
Occurrence of adverse effects and advantages of the LigaSure diathermy system (or LigaSure vessel sealing system) in total thyroidectomy have not been tested in prospective randomized studies comparing its use with that of the time-saving clamp-and-tie technique to ligate and divide thyroid vessels. The effectiveness of LigaSure in achieving vessel division and hemostasis remains dependent on vessel diameter, and the risk of damage to adjacent structures cannot be completely excluded. We tested the hypothesis that use of LigaSure compared with the clamp-and-tie technique can significantly and conveniently reduce operative time without increasing postoperative complications in patients undergoing total thyroidectomy for benign multinodular goiter. ⋯ The use of LigaSure is equally as safe and effective at vessel division and homeostasis as the clamp-and-tie technique, with a statistically significant (although minimal) decrease in mean operative time. Because of this minimal decrease in operative time, use of LigaSure would allow more patients to undergo total thyroidectomy each year, which would eventually help to offset its higher cost.
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Randomized Controlled Trial Comparative Study Clinical Trial
The advantage of total thyroidectomy to avoid reoperation for incidental thyroid cancer in multinodular goiter.
To investigate the impact of total thyroidectomy on the rate of completion thyroidectomy for incidentally found thyroid cancer in euthyroid multinodular goiter. ⋯ We recommend total or near-total thyroidectomy in multinodular goiter to eliminate the necessity for early completion thyroidectomy in case of a final diagnosis of thyroid cancer.