Oncotarget
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Randomized Controlled Trial
Randomized clinical trial comparing the effects of sevoflurane and propofol on carbon dioxide embolism during pneumoperitoneum in laparoscopic hepatectomy.
Laparoscopic hepatectomy carries a high risk of gas embolism due to the extensive hepatic transection plane and large hepatic vena cava. Here, we compared the influence of inhaled and intravenous anesthetics on gas embolism during laparoscopic hepatectomy. Fifty patients undergoing laparoscopic hepatectomy were divided into two groups to receive sevoflurane anesthesia (group S, n = 25) or intravenous propofol anesthesia (group p, n = 25). ⋯ At the point of the most severe gas embolism, the PTCO2 was higher in group S than group p (44.00±4.47 vs. 41.36±2.77 mmHg, p < 0.05), while the PO2/FiO2 (450.52±54.08 vs. 503.80±63.18, p < 0.05) and pH values (7.35±0.05 vs. 7.38±0.02, p < 0.05) were lower in group S than group P. Patients with a history of abdominal surgery or liver cirrhosis had higher gas embolism grades. Thus volatile anesthetics may lengthen the duration of embolism episodes and worsen hemodynamics and pulmonary blood gas exchange during surgery.
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Frailty is a syndrome associated with reduced physiological reserves that increases an individual's vulnerability for developing increased morbidity and/or mortality. While most clinical trials have focused on exercise, nutrition, pharmacologic agents, or a multifactorial approach for the prevention and attenuation of frailty, none have studied the use of cell-based therapies. We hypothesize that the application of allogeneic human mesenchymal stem cells (allo-hMSCs) as a therapeutic agent for individuals with frailty is safe and efficacious. ⋯ Subsequently, in the randomized phase, allo-hMSCs or matched placebo will be administered to patients (n=30) randomly allocated in a 1:1:1 ratio to one of two doses of MSCs versus placebo: Group A (n=10, 100 million allo-hMSCs), Group B (n=10, 200 million allo-hMSCs), and Group C (n=10, placebo). Primary and secondary objectives are, respectively, to demonstrate the safety and efficacy of allo-hMSCs administered in frail older individuals. This study will determine the safety of intravenous infusion of stem cells and compare phenotypic outcomes in patients with aging frailty.
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Randomized Controlled Trial Multicenter Study
Biomarker-driven stratification of disease-risk in non-metastatic medulloblastoma: Results from the multi-center HIT-SIOP-PNET4 clinical trial.
To improve stratification of risk-adapted treatment for non-metastatic (M0), standard-risk medulloblastoma patients by prospective evaluation of biomarkers of reported biological or prognostic significance, alongside clinico-pathological variables, within the multi-center HIT-SIOP-PNET4 trial. ⋯ Biomarkers, established previously in disease-wide studies, behave differently in clinically-defined standard-risk disease. Distinct biomarkers are required to assess disease-risk in this group, and define improved risk-stratification models. Routine testing for specific patterns of chromosome 17 imbalance at the cellular level, and MBWNT, provides a strong basis for incorporation into future trials.
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Randomized Controlled Trial Comparative Study
Erlotinib is effective in pancreatic cancer with epidermal growth factor receptor mutations: a randomized, open-label, prospective trial.
To analyze the efficacy of gemcitabine with or without erlotinib for pancreatic cancer, and to determine the predictive role of epidermal growth factor receptor (EGFR) and KRAS mutations in these patients. ⋯ Gemcitabine plus erlotinib is more effective than gemcitabine alone for treating metastatic pancreatic cancer patients, especially those with EGFR mutations. ClinicalTrials.gov number, NCT01608841.