Clinical efficacy and biomarker analysis of dual PD-1/CTLA-4 blockade in recurrent/metastatic EBV-associated nasopharyngeal carcinoma - Nature Communications

. A dose given more than 3 days after the intended dose date was considered a delay. Both drugs were continued until disease progression, unacceptable toxicity, withdrawal of consent, or study end, whichever occurred first. Clinic visits and physical assessments were done every 6 weeks, tumor assessments were done by investigators per RECIST v1.1 every 12 weeks, and responses were confirmed with follow-up imaging within 6 weeks.

Adverse events were assessed at every visit. Severity of adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0. If a patient experienced more than one incidence of an AE during the trial, the worst grade experienced by the patient was reported.At the end of stage 2 of the Simon 2-stage design, 9 of 26 patients met the BOR criteria.

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Effects of ketogenic diet on health outcomes: an umbrella review of meta-analyses of randomized clinical trials - BMC MedicineBackground Systematic reviews and meta-analyses of randomized clinical trials (RCTs) have reported the benefits of ketogenic diets (KD) in various participants such as patients with epilepsy and adults with overweight or obesity. Nevertheless, there has been little synthesis of the strength and quality of this evidence in aggregate. Methods To grade the evidence from published meta-analyses of RCTs that assessed the association of KD, ketogenic low-carbohydrate high-fat diet (K-LCHF), and very low-calorie KD (VLCKD) with health outcomes, PubMed, EMBASE, Epistemonikos, and Cochrane database of systematic reviews were searched up to February 15, 2023. Meta-analyses of RCTs of KD were included. Meta-analyses were re-performed using a random-effects model. The quality of evidence per association provided in meta-analyses was rated by the GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) criteria as high, moderate, low, and very low. Results We included 17 meta-analyses comprising 68 RCTs (median [interquartile range, IQR] sample size of 42 [20–104] participants and follow-up period of 13 [8–36] weeks) and 115 unique associations. There were 51 statistically significant associations (44%) of which four associations were supported by high-quality evidence (reduced triglyceride (n = 2), seizure frequency (n = 1) and increased low-density lipoprotein cholesterol (LDL-C) (n = 1)) and four associations supported by moderate-quality evidence (decrease in body weight, respiratory exchange ratio (RER), hemoglobin A1c, and increased total cholesterol). The remaining associations were supported by very low (26 associations) to low (17 associations) quality evidence. In overweight or obese adults, VLCKD was significantly associated with improvement in anthropometric and cardiometabolic outcomes without worsening muscle mass, LDL-C, and total cholesterol. K-LCHF was associated with reduced body weight and body fat percentage, but also reduced muscle mass i
Source: BioMedCentral - 🏆 22. / 71 Read more »

Personalized hypertension treatment recommendations by a data-driven model - BMC Medical Informatics and Decision MakingBackground Hypertension is a prevalent cardiovascular disease with severe longer-term implications. Conventional management based on clinical guidelines does not facilitate personalized treatment that accounts for a richer set of patient characteristics. Methods Records from 1/1/2012 to 1/1/2020 at the Boston Medical Center were used, selecting patients with either a hypertension diagnosis or meeting diagnostic criteria (≥ 130 mmHg systolic or ≥ 90 mmHg diastolic, n = 42,752). Models were developed to recommend a class of antihypertensive medications for each patient based on their characteristics. Regression immunized against outliers was combined with a nearest neighbor approach to associate with each patient an affinity group of other patients. This group was then used to make predictions of future Systolic Blood Pressure (SBP) under each prescription type. For each patient, we leveraged these predictions to select the class of medication that minimized their future predicted SBP. Results The proposed model, built with a distributionally robust learning procedure, leads to a reduction of 14.28 mmHg in SBP, on average. This reduction is 70.30% larger than the reduction achieved by the standard-of-care and 7.08% better than the corresponding reduction achieved by the 2nd best model which uses ordinary least squares regression. All derived models outperform following the previous prescription or the current ground truth prescription in the record. We randomly sampled and manually reviewed 350 patient records; 87.71% of these model-generated prescription recommendations passed a sanity check by clinicians. Conclusion Our data-driven approach for personalized hypertension treatment yielded significant improvement compared to the standard-of-care. The model implied potential benefits of computationally deprescribing and can support situations with clinical equipoise.
Source: medical_xpress - 🏆 101. / 51 Read more »