Hereditary Pancreatitis Amlodipine Trial
Bibliographic record
Abstract
OBJECTIVES: Hereditary pancreatitis (HP) is a form of recurrent acute pancreatitis (AP) mediated by mutations in cationic trypsinogen (PRSS1). Mutations cluster in the calcium-associated regulator regions of PRSS1. In rats, calcium-channel blockers (CCB) prevent hyperstimulation-associated AP. Because of the potential importance of hyperstimulation in triggering episodes of AP in HP, we designed a pilot study to evaluate the safety and potential benefit of CCB use in HP. METHODS: Subjects 6 years or older had a PRSS1 mutation, recurrent AP, and pain. Total study duration was 16 weeks. Amlodipine was given during weeks 0 to 11. Dose (2.5, 5, or 10 mg) was based on weight (range, 0.08-0.17 mg x kg(-1) x d(-1)). Subjects filled a daily diary including pain (0-10 scale) and blood pressure reading. Clinical assessments occurred at weeks -4, 0, 1, 2, 6, 10, 11, and 12. Subjects filled a Medical Outcomes Study Short-Form Survey version 2 (SF-10 for children <14 years old) at weeks -4, 0, 6, and 10. Data were compared for weeks -4 to 0 and 6 to 10. RESULTS: Nine subjects signed informed consent (4 males; 12-52 years old). Four were excluded during the screening phase. Drug was discontinued in one due to development of unilateral lower-extremity numbness. Four subjects (12-31 years old) completed the study. Mean blood pressure, laboratory tests, physical findings, and daily pain scores did not clinically significantly differ before and during drug therapy, but all reported reduced symptoms. Three reduced analgesic use. Three had improved scores on the Medical Outcomes Study Short-Form Survey version 2. CONCLUSIONS: Amlodipine is generally safe in subjects with HP and does not increase pain or episodes of AP. Further research into the mechanism of CCB on pancreatitis would be important to provide a pathophysiologic basis to support further trials in HP.
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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 | 0.000 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.007 | 0.001 |
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".