To compare the incidence and outcomes of congenital and neonatal varicella in Australia in the pre-vaccination (1995-1997) and post-vaccination era (after 2005 to November 2020), active prospective national surveillance for congenital varicella syndrome (CVS) and neonatal varicella infection (NVI) was conducted through the Australian Paediatric Surveillance Unit (APSU). Compared with 1995-1997, there was a 91.5% reduction in the incidence of CVS and a 91.3% reduction in the incidence of NVI in 2009-2020. However, almost half of the mothers in 2009-2020 were born overseas and came from countries without a vaccination program. Although there has been a substantial and sustained decrease in the reported incidence of CVS and NVI in Australia since 2006, congenital and neonatal varicella infections persist. Thus, there is an opportunity for targeted screening of varicella in young migrant, asylum seeker and refugee women at risk of varicella infection and prioritisation for vaccination to prevent CVS and NVI.

UNASSIGNED: The Prehospital Optimal Shock Energy for Defibrillation (POSED) study will assess the feasibility of conducting a cluster randomised controlled study of clinical effectiveness in UK ambulance services to identify the optimal shock energy for defibrillation.
UNASSIGNED: POSED is a pragmatic, allocation concealed, open label, cluster randomised, controlled feasibility study. Defibrillators within a single UK ambulance service will be randomised in an equal ratio to deliver one of three shock strategies 120-150-200 J, 150-200-200 J, 200-200-200 J. Consecutive adults (≥18 years) presenting with out of hospital cardiac arrest requiring defibrillation will be eligible. The study plans to enrol 90 patients (30 in each group). Patients (or their relatives for non-survivors) will be informed about trial participation after the initial emergency has resolved. Survivors will be invited to consent to participate in follow-up (i.e., at 30 days or discharge).The primary feasibility outcome is the proportion of eligible patients who receive the randomised study intervention. Secondary feasibility outcomes will include recruitment rate, adherence to allocated treatment and data completeness. Clinical outcomes will include Return of an Organised Rhythm (ROOR) at 2 minutes post-shock, refibrillation rate, Return of Spontaneous Circulation (ROSC) at hospital handover, survival and neurological outcome at 30 days.
UNASSIGNED: The POSED study will assess the feasibility of a large-scale trial and explore opportunities to optimise the trial protocol.Trial registration: ISRCTN16327029.

UNASSIGNED: We aimed to clarify the clinical features and surgical outcomes of descending necrotizing mediastinitis (DNM) to provide a guide for its surgical treatment, focusing on the type of extension and the deployed procedures.
UNASSIGNED: As a joint study of the Japan Broncho-esophagological Society and the Japanese Association for Chest Surgery (JBES1703/JACS1806 study), the clinical data of consecutive patients with DNM who underwent surgical drainage between 2012 and 2016 were collected from 131 participating institutions. The infection limited to the area superior to the carina level was defined as type I; while spreading to the lower mediastinum (LM) as type II. The LM infection limited to the anterior LM, that spread to both the anterior and posterior LM and that limited the posterior LM (type IIC) were further categorized as type IIA, IIB, and IIC, respectively.
UNASSIGNED: A total of 225 patients were ultimately eligible. One hundred patients (44.4%) were categorized as type I, whereas 125 patients were type II (56.6%); The number of type IIA, IIB, and IIC cases was 20 (16%), 62 (49.6%) and 43 (34.4%), respectively. Patients with type I and IIC infections more commonly underwent cervical drainage than patients with type IIA and IIB infections (34.3% and 13.4%, respectively). A total of 8 patients died within 30 days (3.6%, type I/II: 1/7). The 5-year overall survival rate was 68.6%. Type II infection was associated with the 90-day mortality (odds ratio, 5.18; P = .045).
UNASSIGNED: This study demonstrated a previously unclassified group of lower mediastinal extent that is localized within the posterior mediastinum (type IIC). We proposed a new DNM classification including type IIC mediastinitis.

暂无摘要。

OBJECTIVE: To evaluate neurocognitive performance, daily activity and quality of life (QoL), other than usual oncologic outcomes, among patients with brain metastasis ≥5 (MBM) from solid tumors treated with Stereotactic Brain Irradiation (SBI) or Whole Brain Irradiation (WBI).
METHODS: This multicentric randomized controlled trial will involve the enrollment of 100 patients (50 for each arm) with MBM ≥ 5, age ≥ 18 years, Karnofsky Performance Status (KPS) ≥ 70, life expectancy > 3 months, known primary tumor, with controlled or controllable extracranial disease, baseline Montreal Cognitive Assessment (MoCA) score ≥ 20/30, Barthel Activities of Daily Living score ≥ 90/100, to be submitted to SBI by LINAC with monoisocentric technique and non-coplanar arcs (experimental arm) or to WBI (control arm). The primary endpoints are neurocognitive performance, QoL and autonomy in daily-life activities variations, the first one assessed by MoCa Score and Hopkins Verbal Learning Test-Revised, the second one through the EORTC QLQ-C15-PAL and QLQ-BN-20 questionnaires, the third one through the Barthel Index, respectively. The secondary endpoints are time to intracranial failure, overall survival, retreatment rate, acute and late toxicities, changing of KPS. It will be considered significant a statistical difference of at least 30% between the two arms (statistical power of 80% with a significance level of 95%).
CONCLUSIONS: Several studies debate what is the decisive factor accountable for the development of neurocognitive decay among patients undergoing brain irradiation for MBM: radiation effect on clinically healthy brain tissue or intracranial tumor burden? The answer to this question may come from the recent technological advancement that allows, in a context of a significant time saving, improved patient comfort and minimizing radiation dose to off-target brain, a selective treatment of MBM simultaneously, otherwise attackable only by WBI. The achievement of a local control rate comparable to that obtained with WBI remains the fundamental prerequisite.
BACKGROUND: NCT number: NCT04891471.

UNASSIGNED: Although the prevalence of anaphylaxis is increasing worldwide, the large-scale studies in Asia evaluating anaphylaxis in all age groups are limited. We aimed to collect more precise and standardized data on anaphylaxis in Korea using the first multicenter web-based registry.
UNASSIGNED: Twenty-two departments from 16 hospitals participated from November 2016 to December 2018. A web-based case report form, designed by allergy specialists, was used to collect anaphylaxis data.
UNASSIGNED: Within the 2-year period, 558 anaphylaxis cases were registered. The age of registered patients ranged from 2 months to 84 years, and 60% were aged <18 years. In children and adolescents, foods (84.8%) were the most common cause of anaphylaxis, followed by drugs (7.2%); in adults, drugs (58.3%) were the most common cause, followed by foods (28.3%) and insect venom (8.1%). The onset time was ≤10 min in 37.6% of patients. Among the 351 cases registered via the emergency department (ED) of participating hospitals, epinephrine was administered to 63.8% of patients. Among those receiving epinephrine in the ED, 13.8% required 2 or more epinephrine shots. Severe anaphylaxis accounted for 23.5% cases (38.1% in adults; 13.7% in children); patients with drug and insect venom-induced anaphylaxis had higher rates of severe anaphylaxis.
UNASSIGNED: This multicenter registry provides data on anaphylaxis for all age groups for the first time in Asia. The major causes and severity of anaphylaxis were remarkably different according to age group, and the acute treatment features of anaphylaxis in the EDs were examined in detail.

UNASSIGNED: Pancreatoduodenectomy is the treatment of choice for a range of benign and malignant diseases. The pancreatic head must be separated from its supplying vessels, especially the gastroduodenal artery, during this operation. However, dissection of the gastroduodenal artery can disturb blood supply to the liver and result in liver ischemia. There is currently no well-established algorithm to evaluate and ensure sufficient blood flow in patients with altered hepatic artery blood flow. To address this important issue, this study aims to establish a basis for assessing liver blood supply during pancreatoduodenectomy. Furthermore, factors influencing arterial blood flow and related postoperative complications will be evaluated.
UNASSIGNED: The HEPARFLOW study is a single institutional single-arm prospective exploratory observational clinical trial. All consecutive patients undergoing elective partial or total pancreatoduodenectomy will be screened for inclusion until 100 patients are enrolled. Blood flow in the proper hepatic artery, gastroduodenal artery, portal vein, and additional vessels supplying the liver will be measured during pancreatoduodenectomy using Doppler flowmetry. All patients will be followed up for 90 days after surgery. At each visit, standard clinical data, postoperative complications and mortality will be recorded.
UNASSIGNED: This will be the first study to prospectively assess intraoperative flow rates of the hepatic artery and portal vein to evaluate liver blood supply during pancreatoduodenectomy. The preoperative and intraoperative factors influencing blood flow in the hepatic arteries will be identified. This study may also reveal the hemodynamic and clinical relevance of a compression of the celiac axis during pancreatoduodenectomy.
UNASSIGNED: This study was approved by the Ethics Committee of the University of Heidelberg (S-073/2018). The results will be published in a peer-reviewed journal and will be presented at medical meetings.

BACKGROUND: The incidence of nonalcoholic fatty liver disease (NAFLD) has increased recently and is related to obesity and the associated surge in type 2 diabetes mellitus (DM) and metabolic syndrome diagnoses. We aim to compare the effectiveness of tofogliflozin and pioglitazone treatment on hepatic steatosis in patients with NAFLD with type 2 DM.
METHODS: This is an open label, prospective, randomized exploratory study. Patients who meet the inclusion criteria and do not meet any exclusion criteria will undergo magnetic resonance imaging (MRI)-based proton density fat fraction (MRI-PDFF). Patients with ≥10% liver fat content on MRI-PDFF will be randomly assigned to receive tofogliflozin 20 mg per day (n = 20) or pioglitazone 15-30 mg per day (n = 20). MRI will be performed after 24 weeks following initiation of medication therapy. Then, patients will take tofogliflozin and pioglitazone in combination in both groups for 24 weeks. MRI will be performed again at 48 weeks (24 weeks after initiation medication in combination).
RESULTS: Our study\'s primary endpoint will be change in hepatic steatosis measured by MRI-PDFF at 24 weeks after medication therapy. The secondary endpoint will be change in alanine aminotransferase at 24 weeks of medication therapy and the main exploratory endpoint will be changes in liver fat content and liver sclerosis at 48 weeks of medication.
CONCLUSIONS: We will compare the effectiveness of tofogliflozin and pioglitazone treatment using MRI for improving hepatic steatosis in patients with NAFLD complicated by DM and investigate if the combination of these two medications is effective for treating NAFLD.
BACKGROUND: This trial is registered in the Japan Registry of Clinical Trials (jRCTs031180159).
METHODS: 1.2, 14 December 2018.

UNASSIGNED: Pancreatic resection is the only curative treatment for pancreatic cancer. Due to tumor cachexia most patients present with a weight loss at the time of diagnosis. Postoperatively the weight loss is often intensified. Tumor cachexia has an influence on the post-operative morbidity and mortality and on the overall survival. Complementary nutrition has a benefit on the mentioned issues. Needle catheter jejunostomy (NCJ) offers a well-tolerated and safe way for additional nutrition therapy. Until today, the optimal length of postoperative supplementary nutrition has not been evaluated.
UNASSIGNED: The study is designed as a randomized controlled trial to compare the effect of complementary nutritional support until discharge and until 8-weeks after discharge for patients after pancreaticoduodenectomy (PD). The primary endpoint is the comprehensive complications index assessed 12 weeks postoperatively. The grading of the complications will be performed by a blinded assessor. The secondary endpoints are: quality of life, a nutritional assessment and the assessment of the effect on adjuvant therapies and 5-year survival. Follow-up visits are planned 1-, 3-, 6-, 12- and 60 month postoperatively. A total sample size of 140 patients was determined for the analysis of the primary endpoint. The confirmatory analysis will be performed based on the intention-to-treat principle.
UNASSIGNED: The ethics committee of the University of Bern reviewed and approved this study on 22.08.2016 (KEK BE 322/14). The trial was registered in the German Clinical Trial Register (DRKS00010237) on 25.08 2016. The present trial is the first study comparing short- and long-term complementary nutritional support after PD in randomized controlled study. The results will allow a postoperative nutritional therapy after PD based on high quality data. The results will be presented at relevant surgical conferences and written publications of the short-term results and long-term oncologic results are planned within surgical journals.

BACKGROUND: The combination of a fluoropyrimidine [5-fluorouracil (5-FU), capecitabine, or S-1] with a platinum analog (cisplatin or oxaliplatin) is the most widely accepted first-line chemotherapy regimen for metastatic or recurrent advanced gastric cancer (AGC), based on the results of clinical trials. However, there is little evidence to guide chemotherapy for elderly patients with AGC because of under-representation of this age group in clinical trials. Thus, the aim of this study is to determine the optimal chemotherapy regimen for elderly patients with AGC by comparing the efficacies and safeties of combination therapy versus monotherapy as first-line chemotherapy.
METHODS: This study is a randomized, controlled, multicenter, phase III trial. A total of 246 elderly patients (≥70 years old) with metastatic or recurrent AGC who have not received previous palliative chemotherapy will be randomly allocated to a combination therapy group or a monotherapy group. Patients randomized to the combination therapy group will receive fluoropyrimidine plus platinum combination chemotherapy (capecitabine/cisplatin, S-1/cisplatin, capecitabine/oxaliplatin, or 5-FU/oxaliplatin), and those randomized to the monotherapy group will receive fluoropyrimidine monotherapy (capecitabine, S-1, or 5-FU). The primary outcome is the overall survival of patients in each treatment group. The secondary outcomes include progression-free survival, response rate, quality of life, and safety.
CONCLUSIONS: We are conducting this pragmatic trial to determine whether elderly patients with AGC will obtain the same benefit from chemotherapy as younger patients. We expect that this study will help guide decision-making for the optimal treatment of elderly patients with AGC.