Phase II Clinical Trial to Establish Efficacy of a Locally Appropriate Bivalent Anti Snake Venom in Pakistan
Bibliographic record
Abstract
Objective: This study was conducted to determine the efficacy of Snake anti-venom Immunoglobulin [IgG] manufactured by Anti-Snake Venom [ASV]/Anti-Rabies [ARV] Serology Laboratory, Health Department, Government of Sindh. Methods: The prospective, observational single arm study was conducted after the approval of IRB. Study included six patients with viper [Echis carinatus sochureki] snakebites referred to the emergency ward of Peoples University of Medical & Health Sciences Hospital, Nawabshah and District Headquarter Hospital Mithi, Sindh, Pakistan with consultation of Clinical and Principal investigator. The study was conducted over a period of three months [August 2015 to November 2015]. All patients were given IV infusion of 10 mL [1 vial] investigational ASV diluted in 100 mL normal saline except one patient who received 5 mL management dose and 5 mL subsequent dose for the recovery of coagulopathy. The efficacy was assessed by Primary and secondary efficacy endpoints, i.e. the dose at which maximum no of patients were treated [permanent restoration of normal blood coagulation tested by 20-minute whole blood clotting test [20-minute WBCT] with minimum toxicity. Results: All patients recovered from coagulopathy after receiving IV infusion of 10 mL investigational ASV diluted in 100 mL normal saline tested by 20-minute WBCT. Mean Recovery time was 9:15 ± 3:25 hours. Conclusion: Safety and efficacy was assessed for the Bivalent Anti venom Immunoglobulin-NQ1 [IgG] manufactured by ASV/ARV Serology Laboratory, Health Department, Government of Sindh.
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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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 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".