Pedophilia is a disorder of public concern because of its association with child sexual offense and recidivism. Previous neuroimaging studies of potential brain abnormalities underlying pedophilic behavior, either in idiopathic or acquired (i.e., emerging following brain damages) pedophilia, led to inconsistent results. This study sought to explore the neural underpinnings of pedophilic behavior and to determine the extent to which brain alterations may be related to distinct psychopathological features in pedophilia. To this aim, we run a coordinate based meta-analysis on previously published papers reporting whole brain analysis and a lesion network analysis, using brain lesions as seeds in a resting state connectivity analysis. The behavioral profiling approach was applied to link identified regions with the corresponding psychological processes. While no consistent neuroanatomical alterations were identified in idiopathic pedophilia, the current results support that all the lesions causing acquired pedophilia are localized within a shared resting state network that included posterior midlines structures, right inferior temporal gyrus and bilateral orbitofrontal cortex. These regions are associated with action inhibition and social cognition, abilities that are consistently and severely impaired in acquired pedophiles. This study suggests that idiopathic and acquired pedophilia may be two distinct disorders, in line with their distinctive clinical features, including age of onset, reversibility and modus operandi. Understanding the neurobiological underpinnings of pedophilic behavior may contribute to a more comprehensive characterization of these individuals on a clinical ground, a pivotal step forward for the development of more efficient therapeutic rehabilitation strategies. Roux-en-Y gastric bypass (RYGB) has superior long-term diabetes remission outcomes to sleeve gastrectomy (SG). However, in regions with a high prevalence of gastric cancer, RYGB may not be the best option. This study aimed to investigate the anti-diabetic effect of SG with transit bipartition (SG-TB) compared with SG and RYGB. A total of 32 diabetic Sprague-Dawley rat models were assigned to one of four groups SG (n = 8), RYGB (n = 8), SG-TB (n = 8), and SHAM (n = 8). https://www.selleckchem.com/products/fdw028.html Body weight, food intake, blood glucose, and hormonal changes (glucagon-like peptide-1 (GLP-1), insulin, and glucagon) were measured to investigate the effect of surgery in all groups. Oral glucose tolerance test and insulin tolerance test were performed before and 8 weeks after surgery. There were no significant differences in the postoperative changes in body weight and food intake among the SG, RYGB, and SG-TB groups. Postoperatively, the RYGB and SG-TB groups had significantly higher GLP-1 levels and lower insulin levels than the SG group. Further, RYGB and SG-TB had significantly better glucose control improvements than SG. There were no significant differences in GLP-1, insulin, glucagon, and homeostasis model assessment of insulin resistance levels between RYGB and SG-TB. The preoperative and postoperative values of all variables in the SHAM group did not show significant differences. In this study using a diabetes-induced rodent model, we found that the anti-diabetic effect of SG-TB is superior to that of SG and non-inferior to that of RYGB. In this study using a diabetes-induced rodent model, we found that the anti-diabetic effect of SG-TB is superior to that of SG and non-inferior to that of RYGB. In December 2021, U.S. Food & Drug Administration (FDA) will issue guidance on the use of real-world evidence (RWE) to support new indications or expanded product labeling. While difficult to foresee what FDA will require, learnings can be gleaned from previous paradigm shifts at FDA, such as for patient reported outcomes (PROs) in 2006-2009. We contrast published requirements for justifying PROs as fit-for-purpose for a specific labeling claim with a potential approach to justify RWE as fit-for-purpose to support expanded labeling or a new indication. PRO labeling claims require a PRO Evidence Dossier that includes specific wording of claim, clinical trial hypothesis structure and endpoint model, and justification that the PRO is relevant and meaningful to patients in the target population (content validity) with adequate psychometric properties. FDA's 2018 RWE Framework outlined critical considerations for using RWE to support regulatory decisions, including data quality, relevancy, provenance, anand specific study design are fit-for-purpose. Limited abdominal space in congenital diaphragmatic hernia (CDH) might result in abdominal compartment syndrome (ACS) and require delayed abdominal closure (DAC). This study reviewed outcomes in pediatric ACS/DAC after CDH repair. Medline/PubMed, Scopus, Web of Science, Ovid and Lilacs databases were reviewed. Data from studies published in English/Spanish/Portuguese between 1990-2020 was collected. Results are presented as descriptive statistics. Sixteen reports offered 118 children, 112 (94.9%) being neonates. There were six ACS (5.1%) and 112 DAC (94.9%). Regarding ACS, the diagnosis was made clinically (n = 4; 66.7%), using Doppler scans (n = 1; 16.7%) or bladder pressure measurement (n = 1; 16.7%). There was one (16.7%) lethal outcome. The rationale to perform DAC was not clearly stated, and measurement of abdominal pressure was not mentioned in all reports. Silo was the preferred approach in 36 children (32.1%), followed by skin closure only (n = 16; 14.3%), vacuum (n = 10; 8.9%), fascia patch and skin closure (n = 5; 4.5%), fascia patch and vacuum dressing (n = 1; 0.9%), fasciotomy (n = 1; 0.9%); with no DAC technique reported in 43 patients (38.4%). Complications after DAC were reported in nine children (8.1%). One DAC using vacuum dressing that was clinically diagnosed with ACS required silo placement. There were 19 (17%) lethal outcomes. ACS/DAC after CDH repair are reported more frequently in neonates (112/118; 94.9%). There is no clear rationale stated behind the decision to perform DAC, with the silo being the preferred approach. Criteria need to be worked for DAC in CDH with large herniated content and small volume abdomen to prevent ACS. ACS/DAC after CDH repair are reported more frequently in neonates (112/118; 94.9%). There is no clear rationale stated behind the decision to perform DAC, with the silo being the preferred approach. Criteria need to be worked for DAC in CDH with large herniated content and small volume abdomen to prevent ACS.