P.048 Monitoring and managing gastrointestinal events with sodium phenylbutyrate and ursodoxicoltaurine for the treatment of Amyotrophic Lateral Sclerosis
Bibliographic record
Abstract
Background: Sodium phenylbutyrate and ursodoxicoltaurine/taurursodiol (PB&TURSO) is indicated for the treatment of amyotrophic lateral sclerosis (ALS) in Canada and the U.S. In the CENTAUR trial, a phase 2 U.S. multicenter trial in ALS, PB&TURSO was generally well-tolerated. The most common adverse reactions were gastrointestinal (GI) and occurred most often during the first three weeks of therapy. Although the occurrence of GI events in people living with ALS (PLWALS) and treated with PB&TURSO are recognisable and generally manageable, many of the symptoms are often not managed proactively. We sought to develop an evidence-based tool to help guide clinicians on managing diarrhea and abdominal pain in PLWALS and treated with PB&TURSO. Methods: Three ALS specialized neurologists and one gastroenterologist combined their clinical experience, research, and each Medications respective product monograph, to develop a patient-centric GI tool. Results: A guide to monitoring and managing potential GI events with PB&TURSO was developed. The tool provides clinicians a proactive, step-by-step guide to help manage diarrhea and abdominal pain in PLWALS treated with PB&TURSO. Conclusions: The GI tool has the potential to improve monitoring, recognition, and treatment of GI events in PLWALS treated with PB&TURSO. Proactively managing GI events may aid medication adherence and improve patient quality of life.
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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 | 0.003 | 0.009 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.015 | 0.008 |
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".