Purpose: Radiotherapy is used to reduce the risk of breast cancer recurrence after surgery, but it is a potential cause of secondary cancer. We validated the risk of secondary cancer in primary breast cancer who received radiotherapy compared with those who did not from a matched cohort using a large-scale observational study of the Observational Health Data Sciences and Informatics (OHDSI) data network. Materials and Methods: A retrospective comparative cohort study using propensity score-matched cohorts was performed using two Observational Medical Outcome Partnership common data model databases, from tertiary general hospitals in South Korea. Among female patients who underwent surgery after the diagnosis of breast cancer, the risk of secondary primary malignant occurrence after 1:1 matching was analyzed. Results: Among 27,078 patients with breast cancer, there was no significant difference in the risk of secondary cancer following radiotherapy in 4,426 patients after 1:1 propensity-score matching. Further, there were no significant differences in the sensitivity analysis according to age, latency period, and number of radiation treatments. Conclusion There was no difference in the risk of secondary cancer in the patients diagnosed with breast cancer depending on whether or not radiotherapy was performed after surgery. In the future, it is necessary to analyze including data generated during cancer treatment.

Objective: Low-intensity transcranial focused ultrasound (tFUS) has emerged as a promising non-invasive brain stimulation modality with high spatial selectivity and the ability to reach deep brain areas. The present study aimed to investigate the safety and effectiveness of low-intensity tFUS in treating major depressive disorder. Methods: Participants were recruited in an outpatient clinic and randomly assigned to either the verum tFUS or sham stimulation group. The intervention group received six sessions of tFUS stimulation to the left dorsolateral prefrontal cortex over two weeks. Neuropsychological assessments were conducted before and after the sessions. Resting-state functional magnetic resonance imaging (rsfMRI) was also performed to evaluate changes in functional connectivity (FC). The primary outcome measure was the change in depressive symptoms, assessed with the Montgomery–Åsberg Depression Rating Scale (MADRS). Results: The tFUS stimulation sessions were well tolerated without any undesirable side effects. The analysis revealed a significant main effect of session sequence on the MADRS scores and significant interactions between the session sequences and groups. The rsfMRI analysis showed a higher FC correlation between the right superior part of the subgenual anterior cingulate cortex (sgACC) and several other brain regions in the verum group compared with the sham group. Conclusion Our results reveal that tFUS stimulation clinically improved MADRS scores with network-level modulation of a sgACC subregion. This randomized, sham-controlled clinical trial, the first study of its kind, demonstrated the safety and probable efficacy of tFUS stimulation for the treatment of depression.

Purpose: Intraoperative frozen section biopsy is used to reduce the margin positive rate and re-excision rate and has been reported to have high diagnostic accuracy. A majority of breast surgeons in the Republic of Korea routinely perform frozen section biopsy to assess margins intraoperatively, despite its long turnaround time and high resource requirements. This study aims to determine whether omitting frozen section biopsy for intraoperative margin evaluation in selected patients is non-inferior to performing frozen section biopsy in terms of resection margin positivity rate. Methods This study is a phase III, randomized controlled, parallel-group, multicenter non-inferiority clinical trial. Patients meeting the inclusion criteria and providing written informed consent will be randomized to the “frozen section biopsy” or “frozen section biopsy omission” group after lumpectomy. Patients with clinical stage T1–T3 disease who are diagnosed with invasive breast cancer by core-needle biopsy and plan to undergo breast-conserving surgery will be included in this study. If a daughter nodule, non-mass enhancement, or microcalcification is identified on preoperative imaging, these features must be within 1 cm of the main mass for inclusion in the trial. The target sample size is 646 patients per arm. The primary endpoint will be the resection margin positive rate, and the secondary endpoints include the reoperation rate, operating time, residual cancer after reoperation, residual cancer after re-excision according to the frozen section biopsy result, resection volume, patient quality of life, and cost-effectiveness.Discussion: This is the first randomized clinical trial utilizing frozen section biopsy for intraoperative margin evaluation and aims to determine the non-inferiority of omitting frozen section biopsy in selected patients compared to performing frozen section biopsy.We expect that this trial will help surgeons perform the procedure more efficiently while ensuring patient safety.

No abstract available.
Humans ; Leukemia, Myeloid, Acute

Transplantation of islet cells into diabetic patients is a promising therapy, provided that the islet cells are able to evade host immune rejection. With improved islet viability, this strategy may effectively reverse diabetes. We applied 2% calcium alginate to generate small and large capsules to encapsulate porcine neonatal pancreatic cell clusters (NPCCs) using an air-driven encapsulator. After encapsulation, the viability was assessed at 1, 4, 7, 14 and 28 days and secretion of functional insulin in response to glucose stimulation were tested at days 14 and 28. Selective permeability of the small alginate capsules was confirmed using various sizes of isothiocyanate-labeled dextran (FITC-dextran). Encapsulation of NPCCs was performed without islet protrusion in the small and large capsules. The viability of NPCCs in all experimental groups was greater than 90% at day 1 and then gradually decreased after day 7. The NPCCs encapsulated in large capsules showed significantly lower viability (79.50 +/- 2.88%) than that of naive NPCCs and NPCCs in small capsule (86.83 +/- 2.32%, 87.67 +/- 2.07%, respectively) at day 7. The viability of naive NPCCs decreased rapidly at day 14 (75.67 +/- 1.75%), whereas the NPCCs encapsulated in small capsules maintained (82.0 +/- 2.19%). After 14 and 28 days NPCCs' function in small capsules (2.67 +/- 0.09 and 2.13 +/- 0.09) was conserved better compared to that of naive NPCCs (2.04 +/- 0.25 and 1.53 +/- 0.32, respectively) and NPCCs in large capsules (2.04 +/- 0.34 and 1.13 +/- 0.10, respectively), as assessed by a stimulation index. The small capsules also demonstrated selective permeability. With this encapsulation technique, small capsules improved the viability and insulin secretion of NPCCs without islet protrusion.
Alginates/chemistry/metabolism ; Animals ; Animals, Newborn ; Capsules/chemistry ; Cell Survival ; Diabetes Mellitus/pathology/*therapy ; Disease Models, Animal ; Glucuronic Acid/chemistry/metabolism ; Graft Rejection/etiology/*prevention & control ; Hexuronic Acids/chemistry/metabolism ; Humans ; Insulin/secretion ; Islets of Langerhans/*metabolism/pathology ; Islets of Langerhans Transplantation/*methods ; Postoperative Complications/etiology/*prevention & control ; *Swine

OBJECTIVE: Arterial compliance (AC) reflects the buffering function of the vessel. Low AC caused by arterial stiffness increases pulse pressure amplitude. Therefore, Low AC must be correlated with high cardiovascular mobidity and mortality in HD patients. Dialysate calcium concentration is potentially a main determinant of serum ionized calcium level and the vasoconstriction is associated with high calcium concentration. Therefore, We conducted a study for evaluation of the interdialytic effects of treatment with a low dialysate calcium (LdCa) concentration and high dialysate calcium (HdCa) concentration on the changes of AC, BP, biochemical parameters. METHODS: Eight HD patient (mean age 45.5, sex ratio 1 : 1) were studied. The mean HD period was 3 years. Arterial Compliance, stroke Volume, SBP, DBP, PP, MAP, Ionized Ca, T-CO2, P and CaxP product were compared after treatment with a LdCa and HdCa concentration for each 10 sessions. RESULTS: AC were 0.143+/-0.076 mm2/kPa in baseline, 0.166+/-0.097 mm2/kPa in LdCa (1.25 mmol/L) dialysate, 0.142+/-0.082 mm2/kPa in HdCa (1.75 mmol/L) dialysate. SBP, DBP, MAP and PP were 157.75+/-15.97, 94.25+/-9.48, 114.12+/-10.56, 63.50+/-10.87 mmHg in baseline and 135.25+/-13.00, 78.75+/-11.24, 98.37+/-15.14, 56.50+/-5.95 mmHg in LdCa dialysate and 160.50+/-15.36, 94.05+/-10.34, 115.75+/-9.64, 62.00+/-15.71 mmHg in HdCa dialysate. Ionized Ca were 4.66+/-0.40 mg/dL in baseline, 4.45+/-0.28 mg/dL in LdCa dialysate and 4.65+/-0.43 mg/dL in HdCa dialysate. However, there were no changes of other biochemical parameters. CONCLUSION: Treatment with LdCa dialysis, by minimizing the risk for LdCa-induced hypocalcemia, may have a beneficial role in the prevention of the ongoing reduction of arterial compliance in HD patients and thus improve cardiovascular prognosis.
Blood Pressure ; Calcium* ; Compliance ; Dialysis ; Humans ; Hypocalcemia ; Mortality ; Prognosis ; Renal Dialysis* ; Sex Ratio ; Stroke Volume ; Vascular Stiffness ; Vasoconstriction