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OBJECTIVES: To study the potential association between increases in daily mean air temperature and time below range (TBR <54 mg/dl) and time above range (TAR >250 mg/dl) in children and adolescents with type 1 diabetes. RESEARCH DESIGN AND METHODS: Individuals with type 1 diabetes <21 years with information on daily glucose profiles from the diabetes prospective follow-up study (DPV) were included (n = 2582). Further inclusion criteria were age at least 6 months at diabetes onset, diabetes duration for at least one year and treatment years 2020-2021. Mean daily air temperature and other meteorological parameters from 78 measurement stations in Germany were linked to the individual glucose sensor profile via the five-digit postcode areas of residency. We used multivariable repeated measures fractional logistic regression models with a compound symmetry covariance structure to study the association between a 1 °C increase in daily mean temperature and time in specific glucose ranges. RESULTS: A 1 °C increase in daily mean temperature was associated with an acute (Odds Ratio (OR) 1.009 (95%-CI 1.007, 1.011)) and up to 7 days delayed (OR 1.003 (1.001, 1.005)) increase in TBR <54 mg/dl. Moreover, an acute decrease in TAR >250 mg/dl (OR 0.997 (0.996, 0.997)) was found. CONCLUSIONS: Results of the DPV registry showed small, but statistically significant changes in TBR and TAR in association with a short-term temperature increase. Higher blood flow and faster insulin absorption might be one possible mechanism. In times of increasing temperature fluctuations meteorological impacts on time in range could become even more relevant.

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Objective: To record and characterize features of levator ani muscles (LAM) activity in pregnancy and postpartum using non-invasive and novel Magnetomyography (MMG) technique with amplitude and spectral parameters. Methods: Nulliparous women with uncomplicated pregnancies participated in the MMG data collection during rest and voluntary LAM contractions (Kegels) with modulated intensity in third trimester and approximately 2 months postpartum (PP). Simultaneous surface electromyography was recorded to document the recruitment of accessory muscles. Moderate strength Kegel (MK) MMG trials were analyzed. Amplitude and spectral parameters including root-mean square (RMS) amplitude, power spectrum density (PSD) and normalized PSD (rPSD) in three frequency bands (low, middle, high) were computed on MK epochs. Statistical comparisons between pregnancy and postpartum were calculated. Results: MMG recordings were measured from 10 pregnant women. Results showed decreased RMS and power between third trimester and postpartum, trending towards significance. rPSD values in the low frequency band decreased significantly (p = 0.028) from third trimester to postpartum, while significant increase was observed in the middle frequency band (p = 0.018). Conclusions: This study shows that MMG as non-invasive tool has the ability to detect and characterize changes of LAM activity with amplitude and spectral parameters during pregnancy and postpartum.

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Construct validity of novel tablet-based neurocognitive tests (in the NeuroScreen app) measuring processing speed, working memory, and executive functioning in adolescents and young adults (AYA) living with perinatally-acquired HIV (PHIV) and perinatal HIV-exposure without infection (PHEU) was examined. Sixty-two AYA (33 PHIV, 29 PHEU) were recruited from an ongoing longitudinal study (CASAH) in New York City. Medium to large and statistically significant correlations were found between NeuroScreen and gold standard, paper-and-pencil tests of processing speed, working memory, and executive functioning. Results provide partial support for NeuroScreen as an alternative to cumbersome paper-and-pencil tests for assessing neurocognition among HIV-affected AYA.

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Recent studies have shown that occasional short term coupling between fetal and maternal cardiac systems occurs. Fetal magnetocardiography (fMCG) is a non-invasive technique that records the magnetic fields associated with the electrical activity of the fetal heart through sensors placed over the maternal abdomen. The fMCG allows accurate estimation of fetal heart rates (fHR) due to its high signal-to-noise ratio (SNR) and temporal resolution. In this study, we analyzed couplingbetween fHR and maternal heart rates (mHR) using Transfer Entropy (TE). TE determines coupling between two variables by quantifying the information transferred between them in both directions. In this work, we used 74 fMCG recordings to compute TE in both directions over 1-minute disjoint time windows (TW). We examined the effect of fetal movement (FM) as a factor of influence on the TE analysis. We identified 21 subjects with FM during the recording and separated them into two gestational age (GA) groups (GA1<32 and GA2≥32 weeks). Next, TE values were compared between TWs containing non- FM with TWs containing FM using Wilcoxon Signed-Rank test. In addition, we compared TE calculations for non-FM segments obtained from the 74 subjects using Rank-Sum test in the two GA groups. Our results showed that TE values from TWs containing FM are not significantly different than those computed for TWs of non-FM. In both directions, we found that TE values obtained from the 74 subjects did not show any significant difference between GA1 and GA2 which is consistent with previous studies. Our study suggests that FM does not affect the TE computations.

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BACKGROUND: To evaluate the feasibility of using quantitative texture features computed from high frequency ultrasound and ultrasound elastography (USE) images in the discrimination of benign from malignant skin lesions. METHODS: A commercial ultrasound system with a 14 MHz transducer was used to visualize skin lesions requiring biopsy on clinical evaluation. Patients were enrolled over a 6-month period and imaged prospectively by operators blind to the histopathologic diagnosis. Anatomic ultrasound and USE imaging of the skin lesions was performed using a 2-4 mm gel standoff pad before biopsy and histopathologic evaluation. The ElastoAnalysis software developed for the texture analysis of USE images was provided by Hitachi. The software computes thirteen texture features within a region of interest (ROI), which have demonstrated promise in diagnostic characterization of liver fibrosis staging and in quantitative elastography of breast cancer. This approach has not yet been studied in the quantitative assessment of skin cancer. Results were retrospectively compared to the histopathologic diagnosis and a diagnostic criteria with the goal of maximizing sensitivity was evaluated for each textural feature. RESULTS: Of the 37 lesions included, among 30 patients who participated, 12 lesions were malignant and 25 were benign. Eleven out of thirteen textural metrics computed by the software were useful in differentiating benign from malignant lesions with 100% sensitivity and specificities ranging from 28% to 85%. CONCLUSIONS: This feasibility study demonstrated that feature analysis of USE may be useful in quantitatively differentiating cancerous from benign primary solitary skin lesions prior to biopsy.

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OBJECTIVE: Oral diseases and conditions are prevalent among older people with dementia and cognitive impairment. While many interventions have been advocated for use in this population, evidence for their effectiveness is unclear. Our objective was to review systematically the content and effectiveness of interventions and implementation strategies used to improve or maintain the oral health of people with dementia or cognitive impairment. METHODS: Original studies published in English at any time until January 2015 were identified through electronic searches of the Medline, Embase, CINAHL, Scopus and Cochrane databases and hand searches of eligible studies and relevant reviews. Two investigators independently abstracted study characteristics and assessed the methodological quality of eligible studies. Results were presented as a narrative review because significant heterogeneity among included studies precluded a meta-analysis. RESULTS: The 18 included studies varied considerably in terms of size, scope and focus. Only two studies were identified that had been designed specifically for and examined exclusively in people with dementia or cognitive impairment. All studies were in residential care; none was population-based. While several studies reported positive effects, a number of methodological weaknesses were identified and the overall quality of included studies was poor. The specific outcomes targeted varied across studies but most studies focused almost exclusively on proximal clinical oral health outcomes such as levels of dental or denture plaque. Attempts to measure intervention integrity were limited and there was usually little or no effort to evaluate intervention effects over a sustained period. CONCLUSION: There is a lack of high quality evidence to support the effectiveness of oral health interventions and implementation strategies for older people with dementia or cognitive impairment. More rigorous, large scale research is needed in this area. Recommendations are provided to improve the overall quality of evaluation in this area. Emphasis must be placed on developing evidence-based, achievable and sustainable oral health strategies if the needs of people with dementia and cognitive impairment are to be met into the future.

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OBJECTIVE: We propose a method that uses minimal redundancy and maximal relevance (mRMR) based on mutual information as criteria to automatically select references for the frequency-dependent subtraction (SUBTR) method to attenuate maternal (mMCG) and fetal (fMCG) magnetocardiograms of fetal magnetoencephalography recordings. METHODS: mRMR is calculated between all channels and mMCG/fMCG target channels and the most promising sensors are used as references to perform SUBTR. We measured the performance of SUBTR at removing interferences in two steps for different number of references in 38 real datasets. The evaluation was based on the MCG amplitude reduction. We compared the performance of the mRMR approach with random selection of references. RESULTS: Significant differences in interference removal were found when a distinct number of references were chosen by mRMR compared to random selection. CONCLUSION: mRMR provides an effective tool to automatically select a set of featured references. SIGNIFICANCE: Although we show the utility of the mRMR method to biomagnetic signals, the approach can easily be adapted to sensor array data from other applications.

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OBJECTIVE: To test the hypothesis that fetuses exposed to maternal preeclampsia or chronic hypertension have deranged development of cardiac time intervals. STUDY DESIGN: Pregnancies were divided into three groups: Intrauterine Growth Restricted (IUGR), Hypertensive, and Normal. Each group's mean fetal cardiac time intervals (P, PR, QRS and RR) derived by magnetocardiography were calculated using an analysis of covariance model's regression-adjusted estimates for a gestational age of 35 weeks. RESULTS: We reviewed 141 recordings from 21 IUGR, 46 Hypertensive and 74 Normal patients. The IUGR, Hypertensive and Normal groups, respectively, had adjusted mean intervals in milliseconds of 66.4, 66.8 and 76.2 for P (P=0.001), 95.9, 101.6 and 109.6 for PR (P=0.002), 77.2, 78.7 and 78.7 for QRS (P=0.81) and 429.8, 429.2 and 428.5 for RR (P=0.97). CONCLUSION: P and PR intervals are abbreviated in normotrophic fetuses exposed to maternal hypertension, suggesting shortened atrioventricular conduction times.

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Effects of diabetes treatment are strongly connected to individual factors, but the relevant role of gender has not been addressed so far. This observational study evaluates whether monotherapy with lifestyle, metformin or sulfonylurea has gender-specific effects on glycemic control and/or body weight. Data of 9 108 patients with type 2 diabetes from 129 German diabetes centers were assessed by a standardized, prospective, computer-based diabetes care and outcome documentation system (DPV-Wiss-database; age 63.1±12.8 years, diabetes duration 5.7±7.4 years, HbA1c 55±17.7 mmol/mol [7.2±1.6%], BMI 30.6±6.1 kg/m(2), 49.3% female patients). Antidiabetic concepts included lifestyle intervention (n=5,787), metformin (n=2,180), sulfonylurea (n=943) or other antidiabetic drugs (n=198), respectively. HbA1c and body weight were compared before and after a stable monotherapeutical period of 0.8±0.4 years. Women had a significantly higher reduction of body weight after treatment with lifestyle (women-0.8±0.1 vs. men-0.2±0.1 kg; p<0.05), metformin (women-1.8±0.2 vs. men-1.2±0.2 kg; p<0.05) or sulfonylurea drugs (women-0.9±0.2 vs. men - 0.1±0.2 kg; p<0.05), whereas men displayed significantly higher HbA1c-reductions after treatment with lifestyle (women-6.9±0.2 mmol/mol [- 0.6±0.02%] vs. men-7.5±0.2 mmol/mol [0.7±0.02%]; p<0.05) and metformin only (women-6.3±0.3 mmol/mol [- 0.6±0.03%] vs. men - 7.4±0.3 mmol/mol [- 0.7±0.03%]; p<0.05). No differences were seen for sulfonylurea monotherapy concerning the HbA1c-reduction (women - 5.6±0.5 mmol/mol [- 0.5±0.05%] vs. men-6.4±0.4 mmol/mol [- 0.6±0.04%]; p=0.196). In summary, antidiabetic treatment concepts might result in gender-specific effects on body weight and HbA1c. Gender might therefore represent another important factor in the context of an individualized treatment management of type 2 diabetes.

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BACKGROUND: The prevalence of diabetes mellitus type 2 in the adult population is > 7 %. Despite new therapy options and modern insulins, the therapy remains a challenge. Especially in patients with obesity or high insulin resistance it is often difficult to achieve the necessary target values. In most cases the disease is initially asymptomatic so that the aim is the early recognition and avoidance of complications. MATERIAL AND METHODS: This article provides an update on the approach options of modern therapy forms in diabetes management. RESULTS: The foundations of every treatment program are lifestyle interventions, including diabetes schooling. When these fail a pharmaceutical therapy must be initiated which among others is oriented to hemoglobin A1c (HbA1c). The HbA1c target value should take patient-specific circumstances into consideration and should be determined together with the patient. If no contraindications or intolerances are present, metformin is the medication of choice. Apart from metformin, the available data which can be used for guidance are limited. A combination therapy with one or two other oral or injectable medications is suitable to keep the side effects as low as possible. The advantages of other substances in individual cases could be a lower risk of hypoglycemia, reduced weight increase, oral administration and compatibility with renal insufficiency. Ultimately, insulin therapy will be necessary for many patients, either as monotherapy or in combination with other substances. Therapy decisions should be made together with the patient, taking personal preferences into consideration and should include age, body weight, comorbidities, occupational situation and compliance. CONCLUSION: The Reorganization of the Pharmaceutical Market Act represents a momentarily perceived clear barrier. In the interests of an individualized therapy and personalized disease management, a target-aimed flexibility in diabetes management should be possible in the future.

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PURPOSE: To investigate the possibility of increasing elution of fosfomycin, gentamicin, clindamycin, and vancomycin by the addition of dextran fluid during the cement-mixing phase. METHODS: In 12 test series, we produced standardized, antibiotic-loaded test specimens of cement, with and without addition of dextran, and determined their effectiveness against three reference pathogens in agar diffusion and elution tests. RESULTS: In the test series using combined agents, Refobacin(®)-Palacos(®)R plus fosfomycin continuously produced the largest zone of inhibition, both against methicillin-sensitive Staphylococcus aureus (p = 0.009) and against methicillin-resistant Staphylococcus aureus (p = 0.009). The addition of dextran to the various test series had no useful effect on the size of the zone of inhibition for any of the antibiotics tested. CONCLUSIONS: Dextran supplementation in Refobacin(®)-Palacos(®)R bone cement did not have the hope for positive effect on the elution rate of bound antibiotics.

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The role of infection in the etiology of bisphosphonate-related osteonecrosis of the jaw (BRONJ) is poorly understood. Large-scale epidemiological descriptions of the histology and microbiology of BRONJ are not found in the literature. Herein, we present a systematic review of BRONJ histology and microbiology (including demographics, immunocompromised associations, clinical signs and symptoms, disease severity, antibiotic and surgical treatments, and recovery status) validating that infection should still be considered a prime component in the multifactorial disease.

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AIMS: To examine how fasting glucose and glucose tolerance are related to magnetic resonance imaging-assessed indicators of subclinical cerebrovascular disease and brain atrophy and their variation according to age, sex and education. METHODS: Participants in the present study were 172 healthy, community-dwelling older adults. An oral glucose tolerance test was administered and magnetic resonance imaging performed. Fasting, 2-h, and 2-h area-under-the-curve glucose levels, their associations with subclinical cerebrovascular disease and brain atrophy, and their respective interactions with age, sex and education were examined. RESULTS: A positive association between fasting glucose and subclinical cerebrovascular disease (but not brain atrophy) emerged; this association was more pronounced for participants with < 12 years of education; however, glucose tolerance was not related to subclinical cerebrovascular disease or brain atrophy. CONCLUSIONS: Findings revealed a potential link between fasting glucose levels and the presence of subclinical cerebrovascular disease indicators - white matter hyperintensities and silent brain infarction - in older adults without diabetes and with an education level below high school. Additional research is needed to confirm these associations and to determine the need for interventions aimed at closely monitoring and preventing elevated glucose levels in this population to reduce the prevalence of subclinical cerebrovascular disease.

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BACKGROUND: We studied the genetic fingerprints of ovarian cancer and validated the potential of Mammaglobin b (SCGB2A1), one of the top differentially expressed genes found in our analysis, as a novel ovarian tumour rejection antigen. METHODS: We profiled 70 ovarian carcinomas including 24 serous (OSPC), 15 clear-cell (CC), 24 endometrioid (EAC) and 7 poorly differentiated tumours, and 14 normal human ovarian surface epithelial (HOSE) control cell lines using the Human HG-U133 Plus 2.0 chip (Affymetrix). Quantitative real-time PCR and immunohistochemistry staining techniques were used to validate microarray data at RNA and protein levels for SCGB2A1. Full-length human-recombinant SCGB2A1 was used to pulse monocyte-derived dendritic cells (DCs) to stimulate autologous SCGB2A1-specific cytotoxic T-lymphocyte (CTL) responses against chemo-naive and chemo-resistant autologous ovarian tumours. RESULTS: Gene expression profiling identified SCGB2A1 as a top differentially expressed gene in all histological ovarian cancer types tested. The CD8+ CTL populations generated against SCGB2A1 were able to consistently induce lysis of autologous primary (chemo-naive) and metastatic/recurrent (chemo-resistant) target tumour cells expressing SCGB2A1, whereas autologous HLA-identical noncancerous cells were not lysed. Cytotoxicity against autologous tumour cells was significantly inhibited by anti-HLA-class I (W6/32) monoclonal antibody. Intracellular cytokine expression measured by flow cytometry showed a striking type 1 cytokine profile (i.e., high IFN-γ secretion) in SCGB2A1-specific CTLs. CONCLUSION: SCGB2A1 is a top differentially expressed gene in all major histological types of ovarian cancers and may represent a novel and attractive target for the immunotherapy of patients harbouring recurrent disease resistant to chemotherapy.

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OBJECTIVE: In clinical practice Body Mass Index is generally used to evaluate overweight status in adults. The present multicenter study examines whether Body Mass Index (BMI), age- and gender-adjusted Body Mass Index Standard Deviation Score, or calculated %body fat is a better predictor for cardiovascular disease risk factors, specifically hypertension and dyslipidemia, in a high-risk population. METHODS: Data of 42 048 adult type 2 diabetic patients (median age: 67.1 years) from 161 centers in Germany (n=158) and Austria (n=3) registered in a standardized, prospective, computer-based documentation program, were included in the study. For each patient body weight, height, blood pressure and blood lipids were documented. Spearman correlation analyses as well as multivariable logistic regression models were used to examine the relationship between anthropometric measurements and cardiovascular disease risk factors. RESULTS: Correlation and regression analyses revealed minor, non significant differences between the 3 anthropometric measurements (all p>0.05). In both genders, relationships between anthropometric measurements and hypertension or reduced HDL-cholesterol were nearly identical. Only for increased triglycerides, the relations with the 3 anthropometric measurements were significantly stronger in males than in females (p<0.0001, respectively). With increasing age, associations between anthropometric measurements and hypertension, reduced HDL-cholesterol or increased triglycerides became weaker. Spearman correlation coefficients for total cholesterol and LDL-cholesterol revealed weak associations with the 3 anthropometric measurements. CONCLUSION: Compared to Body Mass Index, age- and gender-adjusted Body Mass Index Standard Deviation Score, or calculation of %body fat, has no further benefit to predict cardiovascular disease risk factors in adult type 2 diabetic patients.

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IgG4-related disease has gained increased attention worldwide. While the initial focus was on autoimmune pancreatitis which was first described in Asian populations and turned out to be of relevance in Western populations too, the scope has recently broadened towards a notion of a multi-systemic disease with very diverse manifestations such as autoimmune pancreatitis, IgG4-related sclerosing cholangitis (IgG4-SC), retroperitoneal fibrosis and tubulointerstitial nephritis. IgG4-SC (also known as IgG4-associated cholangitis, IAC) represents a rare but clinically challenging differential diagnosis in patients with obstructive jaundice and proximal extra- or intrahepatic biliary strictures which can be mistaken for cholangiocarcinoma (CC). We present the case of a 79-year-old male patient who presented with obstructive jaundice and biliary strictures at the hepatic duct bifurcation without any evidence for autoimmune pancreatitis and without elevation of serum IgG4-concentrations who underwent hemihepatectomy for suspected CC. However, on histological examination of the resection specimen CC could not be confirmed. It was only after several episodes of obstructive jaundice had reoccurred that the diagnosis of IgG4-SC could be established by reexamination of the surgical specimen which showed extensive infiltration with IgG4-positive plasma cells. Appropriate medical treatment with steroids and azathioprine led to complete remission of the disease. Early recognition of IgG4-SC can save patients from potential harmful and unnecessary surgical interventions. Here we describe the clinical features of this rare case of IgG4-SC with extensive liver tissue infiltration with IgG4-positive cells but without elevated serum IgG4 concentration or evidence of autoimmune pancreatitis. We describe diagnostic criteria for IgG4-SC and review recent insights in pathophysiology and treatment options.

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BACKGROUND/OBJECTIVE: To assess the effects of micronutrient supplementation on head circumference of rural Nepali infants and children. SUBJECTS/METHODS: We used a randomized controlled trial to assess the effects of micronutrient supplementation on head circumference in 569 rural Nepali infants and children aged 4-17 months. Children were randomized to: (1) zinc, (2) iron-folic acid, (3) zinc plus iron-folic acid or (4) a placebo group. Data on head circumference were collected during five visits at ∼3 month intervals over the course of a year. We calculated change in head circumference in treatment groups receiving zinc and iron comparing the first and fifth visits as well as used generalized estimating equations (GEE) to take advantage of data from all points in time. Models were adjusted for covariates unbalanced in the randomization and for baseline head circumference. RESULTS: Estimating differences in head circumference between baseline and visit 5, children in the zinc treatment group showed smaller decreases in head circumference z-score compared with placebo (adjusted ß=0.13, 95% confidence interval (CI): 0.03 to 0.23). Using GEE, zinc treatment was associated with 0.11 (95% CI: 0.05 to 0.17) decrease in the rate of decline in head circumference z-score across visits as compared with placebo. Iron-folic acid supplementation was not associated with head circumference z-scores when comparing visits 1 with 5 or including data across all visits in adjusted models. CONCLUSION: Our results suggest that zinc supplementation confers a beneficial effect on the rate of head growth in Nepali infants.

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HISTORY AND ADMISSION FINDINGS: An 81-year-old man presented with jaundice and a pancreatic tumor. 6 years ago transperitoneal nephrectomy had been performed because of a clear cell renal cancer (pT3b pN0 pM0). INVESTIGATIONS: Laboratory tests showed normocytic anemia and signs of cholestasis. Abdominal ultrasonography revealed a well-defined mass of the head of the pancreas with a diameter of about 4 cm, and a previously diagnosed adrenal mass which had slightly increased in size. Contrast-enhanced ultrasound demonstrated a hyperenhancing of the pancreatic mass, untypical for primary adenocarcinoma of the pancreas. Endoscopic ultrasound-guided fine-needle aspiration disclosed a metastasis of the previously resected renal cancer. TREATMENT AND COURSE: Bilary spincterotomy and stent insertion were performed. Because of proven pancreatic metastasis and suspected adrenal metastasis of renal cancer palliative treatment with multi-targeted receptor tyrosine kinase inhibitor sunitinib was initiated. CONCLUSION: Renal cell carcinomas are the most common primary tumors leading to pancreatic metastasis. In contrast to ductal adenocarcinoma pancreatic metastasis shows hyperenhancement when examined by using contrast-enhanced ultrasonography. Endoscopic ultrasound-guided fine-needle aspiration helps to confirm the suspected diagnosis.

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