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Frost Cramer posted an update 1 day, 11 hours ago
Robotic surgical technology has grown in popularity and applicability, since its conception with emerging uses in general surgery. The robot’s contribution of increased stability and dexterity may be beneficial in technically challenging surgeries, namely, inguinal hernia repair. The aim of this project is to contribute to the growing body of literature on robotic technology for inguinal hernia repair (RIHR) by sharing our experience with RIHR at a large, academic institution. We performed a retrospective chart review spanning from March 2015 to April 2018 on all patients who had undergone RIHR at our university hospital. Extracted data include preoperative demographics, operative features, and postoperative outcomes. Data were analyzed with particular focus on complications, including hernia recurrence. A total of 43 patients were included, 40 of which were male. Mean patient age was 56 (range 18-85 years) and mean patient BMI was 26.4 (range 17.5-42.3). Bilateral hernias were diagnosed in 13 patients. All o discovered during a separate case and was repaired with temporary mesh. The use of the robot is safe and effective and should be considered an acceptable approach to inguinal hernia repair. Future prospective studies will help define which patients will benefit most from this technology.In the USA, the regulatory standard for demonstration of efficacy of a drug is evidence of clinical benefit from adequate and well-controlled clinical trials. Understanding the natural history of disease and how treatment is expected to alter its course, and gathering input from relevant stakeholders, such as patients, caregivers, and clinicians, is essential to understand the best way to measure clinical benefit in a clinical trial. Though pain intensity has been the primary outcome measure in clinical trials for pain, an array of measures assessing clinical outcomes from multiple perspectives can allow for more comprehensive interpretation of how a treatment affects patients’ lives. Careful consideration should be given to how pain affects the feeling and functioning of each distinct patient population and which outcome assessment, or combination of outcome assessments, may be necessary to provide a more comprehensive view of the patient experience. 2-NBDG purchase The early stages of medical product development are an important opportunity to engage with regulatory agencies to discuss potential approaches to clinical trial design and outcome measurement strategies.
Lumbar drainage (LD) is one of the common treatment techniques in neurosurgery. There is a risk of secondary meningitis when using this modality. We aim to predict the probability of the complication by designing a nomogram.
A retrospective study was conducted in a teaching hospital. Data were collected and LD-related meningitis (LDRM) was identified, mainly based on clinical manifestations and cerebrospinal fluid analysis. Univariate analysis was used to screen the risk factors, and binary logistic analysis was performed to build the prediction model, which was furtherly transferred into a nomogram. The prediction performance was evaluated by receiver operating characteristic (ROC) curve, Hosmer-Lemeshow test, and nomogram calibration plot. Internal validation was processed by using ordinary bootstrapping.
A total of 273 patients who match the research criteria were enrolled, in which 37 cases (13.6%) were confirmed to have LDRM. Univariate analysis showed the risk factors included diabetes (p = 0.003), admission on surgical intensive care unit (p = 0.012), duration time (p < 0.001), site leakage (p < 0.001), and craniotomy (p < 0.001). In multivariate analysis, four of the variables were identified as independent risk factors to establish a prediction model, and a graphical nomogram was designed. The area under the ROC curve was 0.837, and the p value in the Hosmer-Lemeshow test was 0.610, with a mean absolute error in the calibration plot calculated as 0.022. The indices in the testing set were in good accordance with the original set when internal validation was performed.
This is the first study to transform the prediction model of LDRM into a nomogram, which can be considered as a tool for clinicians to assess infection risk.
This is the first study to transform the prediction model of LDRM into a nomogram, which can be considered as a tool for clinicians to assess infection risk.Tolvaptan, a vasopressin type-2 receptor antagonist, is indicated for fluid retention. It is considered that the response to tolvaptan reduces as renal function deteriorates, whereas we sometimes experience “non-responders” to tolvaptan despite well-preserved renal function. While the expression of aquaporin-2 might be a key to response to tolvaptan, detailed mechanism of refractoriness to tolvaptan remains unknown. We experienced two patients with congestive heart failure and diabetic nephropathy, in whom the responses to tolvaptan were uniquely opposite. In one case, immunohistochemical staining showed expression of aquaporin-2 in the collecting duct despite severely reduced renal function, followed by the good response to tolvaptan with increased urine output. In another case, immunohistochemical staining showed absence of aquaporin-2 with infiltration of inflammatory cells in the kidney medulla despite relatively preserved renal function, followed by refractoriness to tolvaptan without any increase in urine output. Inactivated aquaporin-2 expression in the collecting duct, which was for example caused by pre-clinical urinary infection as our latter case, might have an association with refractoriness to tolvaptan.
The subcutaneous injection of therapeutic monoclonal antibodies is increasingly used in the treatment of several diseases because of its convenience. Thus, a simple and accurate method of predicting the pharmacokinetics of monoclonal antibodies after a subcutaneous injection in humans would be a valuable tool for preclinical/clinical development. In this study, we investigated whether the pharmacokinetics of monoclonal antibodies after a subcutaneous injection in humans can be predicted using only pharmacokinetic data after a subcutaneous injection in cynomolgus monkeys.
First, we compared the accuracy of three approaches to predict the apparent clearance (CL/F) and apparent volume of distribution (V
/F) for 15 monoclonal antibodies in humans (1) allometric scaling from cynomolgus monkeys; (2) geometric mean of reported values in humans; (3) estimation from a regression line based on CL/F in humans [only V
/F]). Then, using the predicted CL/F and V
/F, and the geometric mean of reported absorption rate constant of mAbs the plasma concentration-time profiles of 13 monoclonal antibodies after subcutaneous injections in humans were simulated.