Data from: Effect of IV glyburide on adjudicated edema endpoints in the GAMES-RP Trial
Bibliographic record
Abstract
Objective: In this secondary analysis of the GAMES-RP trial, we report the effect of IV glyburide on adjudicated, edema-related endpoints. Methods: Blinded adjudicators assigned designations for hemorrhagic transformation, neurological deterioration, malignant edema and edema-related death to patients from the GAMES-RP Phase II randomized controlled trial of IV glyburide for large hemispheric infarct. Rates of these endpoints were compared between treatment arms in the per-protocol sample. In those participants with malignant edema, the effects of treatment on additional markers of edema and clinical determiration were examined. Results: In the per-protocol sample, 41 patients received glyburide and 36 received placebo. There was no difference in the frequency of hemorrhagic transformation [n=24 (58.5%) in IV glyburide versus n=23 (63.9%) in placebo, p=0.91], or the incidence of malignant edema [n=19 (46%) in IV glyburide versus n=17 (47%) in placebo, p=0.94]. However, treatment with IV glyburide was associated with a reduced proportion of deaths attributed to cerebral edema [n=1 (2.4%) with IV glyburide vs. n=8 (22.2%) with placebo, p=0.01)]. In the subset of patients with malignant edema, those treated with IV glyburide had less midline shift (p<0.01) and reduced MMP-9 levels (p<0.01). The glyburide treatment group had lower rate of NIHSS increase of ≥4 during the infusion period [n=7 (37%) in IV glyburide versus n=12 (71%) in placebo, p=0.043], and of change in level of alertness [NIHSS subscore 1a; n=11 (58%) versus n=15 (94%), p=0.016] . Conclusions: IV glyburide was associated with improvements in midline shift, level of alertness and NIHSS, and there were fewer deaths attributed to edema. Additional studies of IV glyburide in large hemispheric infarction are warranted to corroborate these findings. NCT01794182. Level of Evidence: This study provides Class II evidence that for patients with large hemispheric infarction, IV glyburide improves some edema-related endpoints.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.005 | 0.012 |
| Meta-epidemiology (narrow) | 0.002 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.004 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.018 | 0.002 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".