Background: This study aimed to determine whether a shorter high-dose rifampicin regimen is non-inferior to the standard 6-month tuberculosis regimen. Methods: This multicenter, randomized, open-label, non-inferiority trial enrolled participants with respiratory specimen positivity by Xpert MTB/RIF assay or Mycobacterium tuberculosis culture without rifampicin-resistance. Participants were randomized at 1:1 to the investigational or control group. The investigational group received high-dose rifampicin (30 mg/kg/day), isoniazid, and pyrazinamide until culture conversion, followed by high-dose rifampicin and isoniazid for 12 weeks. The control group received the standard 6-month regimen. The primary outcome was the rate of unfavorable outcomes at 18 months post-randomization. The non-inferiority margin was set at <6% difference in unfavorable outcomes rates. The study is registered with ClinicalTrials.gov (NCT04485156) Results: Between 4 November 2020 and 3 January 2022, 76 participants were enrolled. Of these, 58 were included in the modified intention-to-treat analysis. Unfavorable outcomes occurred in 10 (31.3%) of 32 in the control group and 10 (38.5%) of 26 in the investigational group. The difference was 7.2% (95% confidence interval, ∞ to 31.9%), failing to prove non-inferiority. Serious adverse events and grade 3 or higher adverse events did not differ between the groups. Conclusion The shorter high-dose rifampicin regimen failed to demonstrate non-inferiority but had an acceptable safety profile.

Background: This study aimed to determine whether a shorter high-dose rifampicin regimen is non-inferior to the standard 6-month tuberculosis regimen. Methods: This multicenter, randomized, open-label, non-inferiority trial enrolled participants with respiratory specimen positivity by Xpert MTB/RIF assay or Mycobacterium tuberculosis culture without rifampicin-resistance. Participants were randomized at 1:1 to the investigational or control group. The investigational group received high-dose rifampicin (30 mg/kg/day), isoniazid, and pyrazinamide until culture conversion, followed by high-dose rifampicin and isoniazid for 12 weeks. The control group received the standard 6-month regimen. The primary outcome was the rate of unfavorable outcomes at 18 months post-randomization. The non-inferiority margin was set at <6% difference in unfavorable outcomes rates. The study is registered with ClinicalTrials.gov (NCT04485156) Results: Between 4 November 2020 and 3 January 2022, 76 participants were enrolled. Of these, 58 were included in the modified intention-to-treat analysis. Unfavorable outcomes occurred in 10 (31.3%) of 32 in the control group and 10 (38.5%) of 26 in the investigational group. The difference was 7.2% (95% confidence interval, ∞ to 31.9%), failing to prove non-inferiority. Serious adverse events and grade 3 or higher adverse events did not differ between the groups. Conclusion The shorter high-dose rifampicin regimen failed to demonstrate non-inferiority but had an acceptable safety profile.

Background: This study aimed to determine whether a shorter high-dose rifampicin regimen is non-inferior to the standard 6-month tuberculosis regimen. Methods: This multicenter, randomized, open-label, non-inferiority trial enrolled participants with respiratory specimen positivity by Xpert MTB/RIF assay or Mycobacterium tuberculosis culture without rifampicin-resistance. Participants were randomized at 1:1 to the investigational or control group. The investigational group received high-dose rifampicin (30 mg/kg/day), isoniazid, and pyrazinamide until culture conversion, followed by high-dose rifampicin and isoniazid for 12 weeks. The control group received the standard 6-month regimen. The primary outcome was the rate of unfavorable outcomes at 18 months post-randomization. The non-inferiority margin was set at <6% difference in unfavorable outcomes rates. The study is registered with ClinicalTrials.gov (NCT04485156) Results: Between 4 November 2020 and 3 January 2022, 76 participants were enrolled. Of these, 58 were included in the modified intention-to-treat analysis. Unfavorable outcomes occurred in 10 (31.3%) of 32 in the control group and 10 (38.5%) of 26 in the investigational group. The difference was 7.2% (95% confidence interval, ∞ to 31.9%), failing to prove non-inferiority. Serious adverse events and grade 3 or higher adverse events did not differ between the groups. Conclusion The shorter high-dose rifampicin regimen failed to demonstrate non-inferiority but had an acceptable safety profile.

Background: This study aimed to determine whether a shorter high-dose rifampicin regimen is non-inferior to the standard 6-month tuberculosis regimen. Methods: This multicenter, randomized, open-label, non-inferiority trial enrolled participants with respiratory specimen positivity by Xpert MTB/RIF assay or Mycobacterium tuberculosis culture without rifampicin-resistance. Participants were randomized at 1:1 to the investigational or control group. The investigational group received high-dose rifampicin (30 mg/kg/day), isoniazid, and pyrazinamide until culture conversion, followed by high-dose rifampicin and isoniazid for 12 weeks. The control group received the standard 6-month regimen. The primary outcome was the rate of unfavorable outcomes at 18 months post-randomization. The non-inferiority margin was set at <6% difference in unfavorable outcomes rates. The study is registered with ClinicalTrials.gov (NCT04485156) Results: Between 4 November 2020 and 3 January 2022, 76 participants were enrolled. Of these, 58 were included in the modified intention-to-treat analysis. Unfavorable outcomes occurred in 10 (31.3%) of 32 in the control group and 10 (38.5%) of 26 in the investigational group. The difference was 7.2% (95% confidence interval, ∞ to 31.9%), failing to prove non-inferiority. Serious adverse events and grade 3 or higher adverse events did not differ between the groups. Conclusion The shorter high-dose rifampicin regimen failed to demonstrate non-inferiority but had an acceptable safety profile.

Background: This study aimed to determine whether a shorter high-dose rifampicin regimen is non-inferior to the standard 6-month tuberculosis regimen. Methods: This multicenter, randomized, open-label, non-inferiority trial enrolled participants with respiratory specimen positivity by Xpert MTB/RIF assay or Mycobacterium tuberculosis culture without rifampicin-resistance. Participants were randomized at 1:1 to the investigational or control group. The investigational group received high-dose rifampicin (30 mg/kg/day), isoniazid, and pyrazinamide until culture conversion, followed by high-dose rifampicin and isoniazid for 12 weeks. The control group received the standard 6-month regimen. The primary outcome was the rate of unfavorable outcomes at 18 months post-randomization. The non-inferiority margin was set at <6% difference in unfavorable outcomes rates. The study is registered with ClinicalTrials.gov (NCT04485156) Results: Between 4 November 2020 and 3 January 2022, 76 participants were enrolled. Of these, 58 were included in the modified intention-to-treat analysis. Unfavorable outcomes occurred in 10 (31.3%) of 32 in the control group and 10 (38.5%) of 26 in the investigational group. The difference was 7.2% (95% confidence interval, ∞ to 31.9%), failing to prove non-inferiority. Serious adverse events and grade 3 or higher adverse events did not differ between the groups. Conclusion The shorter high-dose rifampicin regimen failed to demonstrate non-inferiority but had an acceptable safety profile.

Objective: To evaluate the feasibility of single-shot whole thoracic time-resolved MR angiography (TR-MRA) to identify the feeding arteries of pulmonary arteriovenous malformations (PAVMs) and reperfusion of the lesion after embolization in patients with multiple PAVMs. Materials and Methods: Nine patients (8 females and 1 male; age range, 23–65 years) with a total of 62 PAVMs who underwent percutaneous embolization for multiple PAVMs and were subsequently followed up using TR-MRA and CT obtained within 6 months from each other were retrospectively reviewed. All imaging analyses were performed by two independent readers blinded to clinical information. The visibility of the feeding arteries on maximum intensity projection (MIP) reconstruction and multiplanar reconstruction (MPR) TR-MRA images was evaluated by comparing them to CT as a reference. The accuracy of TR-MRA for diagnosing reperfusion of the PAVM after embolization was assessed in a subgroup with angiographic confirmation. The reliability between the readers in interpreting the TR-MRA results was analyzed using kappa (κ) statistics. Results: Feeding arteries were visible on the original MIP images of TR-MRA in 82.3% (51/62) and 85.5% (53/62) of readers 1 and 2, respectively. Using the MPR, the rates increased to 93.5% (58/62) and 95.2% (59/62), respectively (κ = 0.760 and 0.792, respectively). Factors for invisibility were the course of feeding arteries in the anteroposterior plane, proximity to large enhancing vessels, adjacency to the chest wall, pulsation of the heart, and small feeding arteries. Thirty-seven PAVMs in five patients had angiographic confirmation of reperfusion status after embolization (32 occlusions and 5 reperfusions).TR-MRA showed 100% (5/5) sensitivity and 100% (32/32, including three cases in which the feeding arteries were not visible on TR-MRA) specificity for both readers. Conclusion Single-shot whole thoracic TR-MRA with MPR showed good visibility of the feeding arteries of PAVMs and high accuracy in diagnosing reperfusion after embolization. Single-shot whole thoracic TR-MRA may be a feasible method for the follow-up of patients with multiple PAVMs.

Background and Objectives: The clinical implications of the BRAF V600E mutation in papillary thyroid microcarcinoma (PTMC), defined as ≤1.0 cm of tumor size, remain controversial. We investigated the association between the BRAFV600E mutation and PTMC recurrence in a retrospective cohort of patients with thyroid cancer. Materials and Methods: This study included 2319 patients with PTMC (median age, 50 years [interquartile range (IQR), 41-57 years]) who underwent thyroid surgery from 2010 to 2019 at a single tertiary medical center. The median follow-up time was 75 months (IQR, 30-98 months). Tumor recurrence was confirmed by histological, cytological, radiographic, and biochemical criteria, combined with persistent and recurrent disease. Results: A total of 60.2% (1395/2319) patients with PTMC had the BRAF V600E mutation. The tumor recurrence rate was 2.1% (19/924) in BRAF mutation-negative patients and 2.9% (41/1395) in BRAF mutation-positive patients, with a hazard ratio (HR) of 1.05 (95% confidence interval [CI], 0.61-1.84) after adjusting for clinicopathological risk factors. Similar results were found in patients with high-risk PTMC (adjusted HR, 1.09; 95% CI, 0.56-2.11) who had lymph node metastasis (LNM), extrathyroidal extension (ETE), or distant metastasis (DM) at diagnosis and in patients with low-risk PTMC (adjusted HR, 1.00; 95% CI, 0.35-2.83) who had no LNM, ETE, or DM. Conclusion The finding that the BRAF V600E mutation was not associated with tumor recurrence in our cohort of Korean patients with PTMC, especially in patients with low-risk PTMC, suggests that its value in the prediction of disease progression is limited.

The purpose of this study is to correlate the material properties of TiZr alloy material (Roxolid) and the mechanical strength of the implant fixture (BLT) through the maximum compressive load test and the fatigue test. Implant samples were purchased with BLT (Roxolid, Straumann, Switzerland) and Octa1 (cold-worked, Megagen Implant, Korea) fixtures made of two materials (TiZr and cold-worked Ti Grade 4). After the maximum compressive load test, the test specimens were analyzed with a optical microscope to confirm the fracture pattern. After the fatigue test, the samples that passed 5 million cycles were analyzed for the precision fit using a scanning electron microscope. Data were analyzed using Student's t-test (α=0.05). In the compressive load test, the small diameter (3.3 mm) implants with the same length and the common diameter (4.1 mm) implants had fracture or bending regardless of the material in both the test and control groups. The fatigue load showed the same results without significance and the gap between the fixture and abutment interface was within 10 µm in both the test and control groups in the precision fit test. There was no statistically significant difference in the maximum compressive load and fatigue test for the comparison of mechanical strength between two systems (BLT vs. Octa1) with same diameter and length, similar shapes and connections.
Alloys ; Fatigue

BACKGROUND: The purpose of this study was to evaluate the clinical outcomes and complications of hook plate fixation in acromioclavicular (AC) joint dislocations and distal clavicle fractures. METHODS: We retrospectively reviewed a series of 60 consecutive patients with hook plate fixation for AC joint dislocation (group I) and distal clavicle fracture (group II). Groups I and II had 39 and 21 patients, respectively. Clinical results were evaluated using the pain visual analogue scale (VAS), simple shoulder test, and Constant-Murley scores. In addition, subacromial erosion and stiffness were evaluated as complications. RESULTS: At the removal, the pain VAS was 2.69 ± 1.30 and 4.10 ± 2.14 in groups I and II, respectively, which were significantly different (p=0.003). The simple shoulder test score was 9.59 ± 1.60 and 7.81 ± 2.67 in groups I and II, respectively, which were also significantly different (p=0.002). Subacromial erosion was significantly more frequent in group II (14/21 patients, 66.7%) than in group I (15/39 patients, 38.5%) (p=0.037), and stiffness was also higher in group II (17/21 patients, 81.0%) than in group I (22/39 patients, 56.4%), but it was not significant. CONCLUSIONS: Hook plate fixation showed good clinical and functional results for the treatment of acute unstable AC joint dislocation and distal clavicle fracture. But, in distal clavicle fractures, there are more subacromial erosion and stiffness compare with acute unstable AC joint dislocation.
Acromioclavicular Joint ; Clavicle ; Dislocations ; Humans ; Joints ; Retrospective Studies ; Shoulder

PURPOSE: The lymph node ratio (LNR) is an important prognostic factor in papillary thyroid carcinoma (PTC), but micrometastases in cervical lymph nodes (LNs) are not of great clinical importance. In this study, we analyzed the accuracy of prediction of the prognosis depending on whether micrometastases were included in the number of metastatic LNs when calculating LNR. METHODS: The study included 353 PTC patients who underwent total thyroidectomy with neck LN dissection, and calculated LNR by 2 methods according to whether micrometastases were included in the number of metastatic LNs: Method 1 did not and method 2 did include. To compare the predictive values of LNR by the 2 methods, correlation coefficients and receiver operating characteristic (ROC) curves were analyzed. RESULTS: Positive correlations were found between LNR and preablation stimulated thyroglobulin (sTg) levels in both methods, but the correlation between method 1 LNR and preablation sTg level was significantly stronger than that for method 2 (Fisher z = 1.7, P = 0.045). The areas under these 2 independent ROC curves were analyzed; the prognostic efficacy of method 1 LNR was more accurate than that of method 2 LNR, and the difference was statistically significant (P = 0.0001). CONCLUSION: Regional recurrence of PTC can be predicted more accurately by not including micrometastases in the number of metastatic LNs when calculating LNR.
Humans ; Lymph Nodes* ; Methods ; Neck ; Neoplasm Micrometastasis* ; Prognosis ; Recurrence ; ROC Curve ; Thyroglobulin ; Thyroid Gland* ; Thyroid Neoplasms* ; Thyroidectomy