Preliminary Trial of Intra-articular LMWF-5A for Osteoarthritis of the Knee
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Bibliographic record
Abstract
This study was conducted to investigate the safety and efficacy of 3 intraarticular injections of the low-molecular-weight fraction of 5% human serum albumin (LMWF-5A) administered every 2 weeks for knee pain as a result of osteoarthritis. This single-center, randomized, vehicle-controlled, double-blind, phase II study was designed to ensure the safety of multiple intra-articular injections of LMWF-5A and to explore its efficacy in reducing pain as a result of knee osteoarthritis. Patients were randomized 1:1 to receive 3 biweekly intra-articular knee injections of either 4 mL LMWF-5A or vehicle control (saline), administered at weeks 0 (baseline), 2, and 4. Safety was examined as the incidence and severity of adverse events. Efficacy was assessed by the mean (SD) change between treatment groups in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score from baseline to week 20. A total of 40 patients were randomized and received treatment. No drug-related serious adverse events and no deaths were reported. Adverse events were similar in patients who received saline (18, 90%) and LMWF-5A (19, 95%). Those treated with LMWF-5A had a significant decrease in pain at 20 weeks compared with the saline group (-1.41 [SD, 0.81] vs -0.85 [SD, 0.64], P=.02), corresponding to improvement in pain at week 20 of 64% with LMWF-5A compared with 40% with saline. This preliminary clinical trial showed that repeated intra-articular injections of LMWF-5A are safe when administered at 2-week intervals and are effective in providing relief of the pain of osteoarthritis of the knee at 20 weeks. [Orthopedics. 2017; 40(1):e49-e53.].
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Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
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 it