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All sourcesNASA NTRSDOE OSTI
DOE OSTI2021

Effect of dehydroepiandrosterone administration before in vitro fertilization on the live birth rate in poor ovarian responders according to the Bologna criteria: A randomised controlled trial

Abstract Objective To evaluate the effect of dehydroepiandrosterone (DHEA) pre‐treatment before in vitro fertilization and embryo transfer (IVF‐ET) on the live birth rate in infertile women with poor ovarian response (POR) defined according to the Bologna criteria. Design A randomized, double‐blind, placebo‐controlled trial. Setting Nine reproductive medical centers in China. Population A total of 821 participants with POR defined according to the Bologna criteria were enrolled in the study between April 2016 and December 2018. Methods Eligible participants were randomly assigned to receive either DHEA ( n = 410) or placebo ( n = 411) treatments for 4–12 weeks prior to IVF‐ET, in a 1:1 ratio. Main outcome measures Live birth rate after the first embryo transfer. Results Thirty‐six (8.8%) of 410 women in the DHEA group and 37 (9.0%) of 411 women in the placebo group had a live birth, with no significant difference observed between groups (relative risk, 0.98, 95% CI, 0.63–1.51; p = 0.911). There were no significant differences in the number of retrieved oocytes, and the rates of clinical pregnancy, pregnancy loss, and cumulative live births between the two groups. Conclusions DHEA administration prior to IVF‐ET had no beneficial effect on the live birth rate relative to placebo in women with POR defined according to the Bologna criteria. Tweetable Abstract No benefit was found in poor ovarian responders who received DHEA administration prior to IVF.

Wang, Ze↗
DOE OSTI2025

Cognitive behavioural therapy targeting cardiac anxiety post-myocardial infarction: results from two sequential pilot studies

Abstract Aims Cardiac anxiety, which is cardiac-related fear and avoidance behaviours, is common following myocardial infarction (MI) and has been associated with increased risk for cardiovascular events. However, there are currently no treatments specifically designed to target cardiac anxiety. The aim of the two pilot studies was to evaluate an exposure-based cognitive behavioural therapy protocol (MI-CBT) targeting cardiac anxiety following MI, assessing feasibility, acceptability, and the intervention's potential for reducing cardiac anxiety and improving health-related quality of life (QoL). Methods and results A series of two sequential, uncontrolled pilot studies were conducted. In Pilot Study 1 (n = 15), MI-CBT was delivered via face-to-face videoconference, while Pilot Study 2 (n = 23) was delivered online. Patients with a history of MI (≥6 months before assessment, type 1 ST- or non-ST-segment elevation MI, and elevated cardiac anxiety as per clinical interview) were included. The interventions lasted 8 weeks and were therapist-led, with key components including exposure to cardiac-related symptoms and reduction of avoidance behaviours. Participants completed self-rated assessments, including the Cardiac Anxiety Questionnaire (CAQ) and the 12-Item Short Form Health Survey (SF-12), at baseline, post-treatment, and 6-month follow-up. Treatment adherence and satisfaction were high. Cognitive behavioural therapy led to a large reduction in cardiac anxiety, as measured by the CAQ (P < 0.001), and significant improvements in health-related QoL, as measured by the SF-12 (P < 0.001), in both pilot studies. Conclusion These studies suggest that exposure-based CBT is a feasible, acceptable, and promising approach to reduce cardiac anxiety and improve QoL following MI. A randomized controlled trial should be conducted to evaluate the efficacy of the intervention.

Johnsson, Amanda (ORCID:0009000862983934)↗
DOE OSTI2022

Graph-based featurization methods for classifying small molecule compounds

For over a decade, drug-induced liver injury (DILI) has posed significant drawbacks in the synthesis and development of drugs and remains a consequential concern. With finite success within the existing preclinical models, DILI is one of the main causes of drug withdrawal or termination from the market. Particularly, this withdrawal occurs during the late stages of drug development (Kullak-Ublick, 2017). Since DILI is difficult to diagnose and treat, it has become an obstacle in the drug production market that in turn affects clinicians, pharmaceutical companies, and consumers. We propose a method for learning features of DILI-positive drugs based on the graphical relationships and patterns they possess within a network of biological databases. We also train various statistical and machine learning models on these learned features in order to classify the drugs as DILI-positive or negative. Our methods include Random Forest, Neural networks, and logistic regression classification. We utilize labeled DILI-positive and DILI-negative datasets, which were developed by the FDA and the National center for toxicological research, as well as additional literature datasets (Thakkar, 2020) in order to validate our results and assess our featurization and model accuracy.

37 INORGANIC, ORGANIC, PHYSICAL, AND ANALYTICAL CH↗
DOE OSTI2020

Machine learning prediction of incidence of Alzheimer’s disease using large-scale administrative health data

Nationwide population-based cohort provides a new opportunity to build an automated risk prediction model based on individuals’ history of health and healthcare beyond existing risk prediction models. We tested the possibility of machine learning models to predict future incidence of Alzheimer’s disease (AD) using large-scale administrative health data. From the Korean National Health Insurance Service database between 2002 and 2010, we obtained de-identified health data in elders above 65 years (N = 40,736) containing 4,894 unique clinical features including ICD-10 codes, medication codes, laboratory values, history of personal and family illness and socio-demographics. To define incident AD we considered two operational definitions: “definite AD” with diagnostic codes and dementia medication (n = 614) and “probable AD” with only diagnosis (n = 2026). We trained and validated random forest, support vector machine and logistic regression to predict incident AD in 1, 2, 3, and 4 subsequent years. For predicting future incidence of AD in balanced samples (bootstrapping), the machine learning models showed reasonable performance in 1-year prediction with AUC of 0.775 and 0.759, based on “definite AD” and “probable AD” outcomes, respectively; in 2-year, 0.730 and 0.693; in 3-year, 0.677 and 0.644; in 4-year, 0.725 and 0.683. The results were similar when the entire (unbalanced) samples were used. Important clinical features selected in logistic regression included hemoglobin level, age and urine protein level. This study may shed a light on the utility of the data-driven machine learning model based on large-scale administrative health data in AD risk prediction, which may enable better selection of individuals at risk for AD in clinical trials or early detection in clinical settings.

97 MATHEMATICS AND COMPUTING↗
DOE OSTI2022

Exploratory study reveals far reaching systemic and cellular effects of verapamil treatment in subjects with type 1 diabetes

Currently, no oral medications are available for type 1 diabetes (T1D). While our recent randomized placebo-controlled T1D trial revealed that oral verapamil had short-term beneficial effects, their duration and underlying mechanisms remained elusive. Now, our global T1D serum proteomics analysis identified chromogranin A (CHGA), a T1D-autoantigen, as the top protein altered by verapamil and as a potential therapeutic marker and revealed that verapamil normalizes serum CHGA levels and reverses T1D-induced elevations in circulating proinflammatory T-follicular-helper cell markers. RNA-sequencing further confirmed that verapamil regulates the thioredoxin system and promotes an anti-oxidative, anti-apoptotic and immunomodulatory gene expression profile in human islets. Moreover, continuous use of oral verapamil delayed T1D progression, promoted endogenous beta-cell function and lowered insulin requirements and serum CHGA levels for at least 2 years and these benefits were lost upon discontinuation. Thus, the current studies provide crucial mechanistic and clinical insight into the beneficial effects of verapamil in T1D.

60 APPLIED LIFE SCIENCES↗
DOE OSTI2023

A randomised sham-controlled study evaluating rTMS analgesic efficacy for postherpetic neuralgia

Context Postherpetic neuralgia (PHN) is a refractory neuropathic pain condition in which new treatment options are being developed. Repetitive transcranial magnetic stimulation (rTMS) may have the potential to reduce pain sensations in patients with postherpetic neuralgia. Objectives This study investigated the efficacy on postherpetic neuralgia by stimulating two potential targets, the motor cortex (M1) and the dorsolateral prefrontal cortex (DLPFC). Methods This is a double-blind, randomised, sham-controlled study. Potential participants were recruited from Hangzhou First People’s Hospital. Patients were randomly assigned to either the M1, DLPFC or Sham group. Patients received ten daily sessions of 10-Hz rTMS in 2 consecutive weeks. The primary outcome measure was visual analogue scale (VAS) assessed at baseline, first week of treatment (week 1), post-treatment (week 2), 1-week (week 4), 1-month (week 6) and 3-month (week 14) follow-up. Results Of sixty patients enrolled, 51 received treatment and completed all outcome assessments. M1 stimulation resulted in a larger analgesia during and after treatment compared to the Sham (week 2 – week 14, p < 0.005), as well as to the DLPFC stimulation (week 1 – week 14, p < 0.05). In addition to pain, sleep disturbance was significantly improved and relieved by targeting either the M1 or the DLPFC (M1: week 4 – week 14, p < 0.01; DLPFC: week 4 – week 14, p < 0.01). Moreover, pain sensations following M1 stimulation uniquely predicted improvement in sleep quality. Conclusion M1 rTMS is superior to DLPFC stimulation in treating PHN with excellent pain response and long-term analgesia. Meanwhile, M1 and DLPFC stimulation were equally effective in improving sleep quality in PHN. Clinical trial registration https://www.chictr.org.cn/ , identifier ChiCTR2100051963.

Wang, Huan↗
DOE OSTI2020

Effects of Testosterone Supplementation on Ghrelin and Appetite During and After Severe Energy Deficit in Healthy Men

Abstract Background Severe energy deficits cause interrelated reductions in testosterone and fat free mass. Testosterone supplementation may mitigate those decrements, but could also reduce circulating concentrations of the orexigenic hormone ghrelin, thereby exacerbating energy deficit by suppressing appetite. Objective To determine whether testosterone supplementation during severe energy deficit influences fasting and postprandial ghrelin concentrations and appetite. Design and methods Secondary analysis of a randomized, double-blind trial that determined the effects of testosterone supplementation on body composition changes during and following severe energy deficit in nonobese, eugonadal men. Phase 1 (PRE-ED): 14-day run-in; phase 2: 28 days, 55% energy deficit with 200 mg testosterone enanthate weekly (TEST; n = 24) or placebo (PLA; n = 26); phase 3: free-living until body mass recovered (end-of-study; EOS). Fasting and postprandial acyl ghrelin and des-acyl ghrelin concentrations and appetite were secondary outcomes measured during the final week of each phase. Results Fasting acyl ghrelin concentrations, and postprandial acyl and des-acyl ghrelin concentrations increased in PLA during energy deficit then returned to PRE-ED values by EOS, but did not change in TEST (phase-by-group, P < 0.05). Correlations between changes in free testosterone and changes in fasting acyl ghrelin concentrations during energy deficit (ρ = -0.42, P = 0.003) and body mass recovery (ρ = -0.38; P = 0.01) were not mediated by changes in body mass or body composition. Transient increases in appetite during energy deficit were not affected by testosterone treatment. Conclusions Testosterone supplementation during short-term, severe energy deficit in healthy men prevents deficit-induced increases in circulating ghrelin without blunting concomitant increases in appetite. Clinical Trials Registration www.clinicaltrials.gov NCT02734238 (registered 12 April 2016).

Karl, J. Philip↗