A Clinical Trial of Nitrosense patch for the treatment of patients with painful diabetic neuropathy.
Bibliographic record
Abstract
AIMS: Impaired nitric oxide synthesis has been implicated as one of the underlying causes of diabetic painful neuropathy (DPN). Hence, effects of a cutaneous, nitric oxide releasing patch (NitroSense Derma Protect) were evaluated in subjects with DPN. METHODS: Fifty diabetics were randomised to active/placebo arms after a 2 wk wash-out period. Patients received 24 mg patches (each patch releases around 9 nmol/cm2/min of nitric oxide) for 3 hrs, every other day during a 3 wks period, or indistinguishable placebo patches. The extent of pain was recorded at start, at each visit and following completion of the study. Changes in pain from baseline were measured using the 11 point lickert scale (PLS), visual analogue scale (VAS), short form mcgill, pain questionnaire (SF-MPQ), present pain intensity (PPI) scale. RESULTS: Subjects treated with patch experienced a statistically significant reduction in pain from baseline when compared to placebo (PLS scale; p = 0.05). Defining responders as subjects with a > 50% reduction in PLS score from baseline, the number needed to treat (NNT) was calculated as 3.0. A significant post-treatment decrease (p = 0.009) in vibration perception threshold (VPT) for left foot after active treatment was observed. CONCLUSIONS: Present results highlight utility of NitroSense Derma Protect as controllable nitric oxide source for patients with DPN.
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How this classification was reachedexpand
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 | 0.001 | 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 itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, 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".