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BackgroundTraumatic brain injury (TBI) is a major cause of death and disability worldwide. Progesterone has been shown to improve neurologic outcome in multiple experimental models and two early-phase trials involving patients with TBI.MethodsWe conducted a double-blind, multicenter clinical trial in which patients with severe, moderate-to-severe, or moderate acute TBI (Glasgow Coma Scale score of 4 to 12, on a scale from 3 to 15, with lower scores indicating a lower level of consciousness) were randomly assigned to intravenous progesterone or placebo, with the study treatment initiated within 4 hours after injury and administered for a total of 96 hours. Efficacy was defined as an increase of 10 percentage points in the proportion of patients with a favorable outcome, as determined with the use of the stratified dichotomy of the Extended Glasgow Outcome Scale score at 6 months after injury. Secondary outcomes included mortality and the Disability Rating Scale score.ResultsA total of 882 of the planned sample of 1140 patients underwent randomization before the trial was stopped for futility with respect to the primary outcome. The study groups were similar with regard to baseline characteristics; the median age of the patients was 35 years, 73.7% were men, 15.2% were black, and the mean Injury Severity Score was 24.4 (on a scale from 0 to 75, with higher scores indicating greater severity). The most frequent mechanism of injury was a motor vehicle accident. There was no significant difference between the progesterone group and the placebo group in the proportion of patients with a favorable outcome (relative benefit of progesterone, 0.95; 95% confidence interval [CI], 0.85 to 1.06; P=0.35). Phlebitis or thrombophlebitis was more frequent in the progesterone group than in the placebo group (relative risk, 3.03; CI, 1.96 to 4.66). There were no significant differences in the other prespecified safety outcomes.ConclusionsThis clinical trial did not show a benefit of progesterone over placebo in the improvement of outcomes in patients with acute TBI. (Funded by the National Institute of Neurological Disorders and Stroke and others; PROTECT III ClinicalTrials.gov number, NCT00822900.).

Context: Depression is prevalent among Asian Americans (AsA) during the COVID-19 pandemic, and depression often leads to sleep disturbance in this population. The gut microbiota (GM) plays a critical role in mental health and sleep quality, and the composition of the GM is largely unknown among AsA. Objectives: Examine associations of the GM with depressive symptoms and sleep disturbance among Chinese and Korean American immigrants. Methods: Depressive symptoms (PROMIS Short Form-Depression) and sleep quality (Pittsburgh Sleep Quality Index [PSQI]) were collected via surveys. PROMIS measure T-score > 55 indicates positive depressive symptoms, and a total PSQI score > 5 indicates sleep disturbance. 16S rRNA V3-V4 gene regions were sequenced from fecal specimens to measure GM. Permutational multivariate analysis of variance and linear discriminant analysis effect size were applied to examine associations of the GM with symptoms. Results: Among 20 participants, 55% (n = 11) reported depressive symptoms and 35% (n = 7) reported sleep disturbance. A higher α-diversity was marginally associated with lower depressive symptoms: Chao1 (r = −0.39, p = 0.09) and Shannon index (r = −0.41, p = 0.08); β-diversity distinguished participants between categories of depressive symptoms (weighted UniFrac, p =0.04) or sleep disturbance (Jaccard, p =0.05). Those with depressive symptoms showed a higher abundance of Actinobacteria, while those without depressive symptoms had a higher abundance of Bacteroidetes. No significant taxa were identified for sleep disturbance. Conclusions: Gut microbial diversity showed promising associations with depressive symptoms and sleep disturbance among Chinese and Korean immigrants. Specific taxa were identified as associated with depressive symptoms. Future studies with a larger sample size are warranted to confirm our findings. [ABSTRACT FROM AUTHOR]

Our objective was to assess the reproducibility and accuracy of fat and of fruit and vegetable items on a 43-item food frequency questionnaire (FFQ) previously self-administered by students at 16 US medical schools. Five in-person, 24-hour recalls were administered between two FFQ administrations to 88 medical students. Reported fat intake decreased from the first (34.7%) to the second (33.1%) FFQ administration (P<.001); the reproducibility correlation was r=0.63. Fat intake from recalls (28.4%) was lower than that from the FFQ (33.8%, P<.001). The Pearson correlation was r=0.36. Fruit and vegetable servings per day were 3.9 and 3.7 from the first and second FFQ, respectively (P=.5); the reproducibility correlation was r=0.77. Fruit and vegetable servings were marginally higher from recalls (4.3) than from the FFQ (3.8, P=.06). The Pearson correlation for fruit and vegetable servings was r=0.50. This brief FFQ provides acceptably reproducible and valid estimates of fruit and vegetable servings per day among most groups of medical students, but overestimates fat as a percentage of energy intake. J Am Diet Assoc. 2005;105:802-806.

Patients were randomly assigned with transient ischemic attack or stroke caused by angiographically verified 50 to 99 percent stenosis of a major intracranial artery to receive warfarin in a double-blind multicenter clinical trial. Results revealed warfarin to be associated with significantly higher rates of adverse events and also provided no benefit over aspirin in this trial.

Chronic kidney disease of unknown etiology (CKDu) has been well described in farmworkers in Latin America. Agricultural workers in the United States (US) are exposed to similar hot and humid working conditions, but CKDu in the US is under-described. This review aims to better understand the current literature describing the connection between heat stress and kidney function in farmworkers in the United States. Utilizing a scoping review methodology, we searched CINAHL, Embase, PubMed, and Web of Science databases to better understand the current state of the heat stress and kidney function research in farmworkers within the United States. In this review, 229 pieces of literature were screened. Ultimately, 4 articles were chosen to be included in the scoping review. Common themes within the articles were variations in study protocol lengths and type of heat stress measurement. Additionally, the majority of the work completed was quantitative to date, with only one study providing a critical social lens for analysis of CKDu in the United States. We found evidence that more work is needed within the US to understand the relationship between working in the heat and kidney function in agricultural and other workers who experience high heat conditions at work and are susceptible to the deleterious effects of working in said conditions. [ABSTRACT FROM AUTHOR]

Objective: Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease that is incurable and ultimately fatal. Few therapeutic options are available to patients. In this study, we explored differences in microbiome composition associated with ALS. Methods: We compared the gut microbiome and inflammatory marker profiles of ALS patients (n = 10) to those of their spouses (n = 10). Gut microbiome profiles were determined by 16S rRNA gene sequencing. Results: The gut microbial communities of the ALS patients were more diverse and were deficient in Prevotella spp. compared with those of their spouses. In contrast, healthy couples (n = 10 couples of the opposite sex) recruited from the same geographic region as the patient population did not exhibit these differences. Stool and plasma inflammatory markers were similar between ALS patients and their spouses. Predictive analysis of microbial enzymes revealed that ALS patients had decreased activity in several metabolic pathways, including carbon metabolism, butyrate metabolism, and systems involving histidine kinase and response regulators. Conclusions: ALS patients exhibit differences in their gut microbial communities compared with spouse controls. Our findings suggest that modifying the gut microbiome, such as via amelioration of Prevotella spp. deficiency, and/or altering butyrate metabolism may have translational value for ALS treatment. [ABSTRACT FROM AUTHOR]