Trial · NCT07904533
Registered outcomes34
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 34
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of participants with favorable neurological outcomes at 6 months | At 6 months post-treatment | Unit of measure: Percentage (%). A favorable neurological outcome is defined as meeting both of the following criteria: (1) a modified Rankin Scale score of 0 to 2, AND (2) at least one of the following: an improvement in the Mini-Mental State Examination score of ≥2 points from baseline, or a Mini-Mental State Examination score of \>26. The Mini-Mental State Examination score ranges from 0 to 30, with higher scores indicating better cognitive function. The modified Rankin Scale score ranges from 0 to 6, with higher scores indicating worse disability. |
| Secondary | Proportion of participants with normal cerebrospinal fluid (CSF) white blood cell counts | At 6 months post-treatment | Unit of measure: Percentage (%). The proportion of participants with normal cerebrospinal fluid (CSF) white blood cell counts (≤5 cells/μL; or ≤20 cells/μL for participants with HIV) at 6 months, as measured by CSF analysis. |
| Secondary | Proportion of participants with normal cerebrospinal fluid (CSF) protein levels | At 6 months post-treatment | Unit of measure: Percentage (%). The proportion of participants with normal cerebrospinal fluid (CSF) protein levels (\<500 mg/L) at 6 months post-treatment, as measured by CSF biochemical analysis. |
| Secondary | Proportion of participants with a ≥4-fold decline or seroreversion in cerebrospinal fluid (CSF) non-treponemal antibody titers | At 6 months post-treatment | Unit of measure: Percentage (%). The proportion of participants with a ≥4-fold decline or seroreversion in cerebrospinal fluid (CSF) non-treponemal antibody titers. Titers are measured by Venereal Disease Research Laboratory (VDRL), toluidine red unheated serum test (TRUST), or rapid plasma reagin (RPR) tests on CSF samples. Notably, titer assessments must use the same assay method as the baseline measurement; results from different methods are not comparable. |
| Secondary | Proportion of participants with a ≥4-fold decline or seroreversion in serum non-treponemal antibody titers | At 6 months post-treatment | Unit of measure: Percentage (%). The proportion of participants with a ≥4-fold decline or seroreversion in serum non-treponemal antibody titers, measured by toluidine red unheated serum test (TRUST) or rapid plasma reagin (RPR) tests on serum samples. Notably, titer assessments must use the same assay method as the baseline measurement; results from different methods are not comparable. |
| Secondary | Proportion of participants with a modified Rankin Scale (mRS) score of 0 to 2 | At 6 months post-treatment | Unit of measure: Percentage (%). The proportion of participants with a modified Rankin Scale (mRS) score of 0 to 2 at 6 months post-treatment. The mRS is a 7-point scale ranging from 0 to 6, where a score of 0 indicates no symptoms and a score of 6 indicates death. A score of 0 to 2 indicates functional independence (a favorable outcome). Higher scores indicate worse disability. |
| Secondary | Proportion of participants with a ≥2-point improvement or a score >26 in the Mini-Mental State Examination | At 6 months post-treatment | Unit of measure: Percentage (%). The proportion of participants meeting at least one of the following criteria at 6 months: (1) an improvement of ≥2 points from baseline in the Mini-Mental State Examination (MMSE) score, or (2) an MMSE score of \>26. The MMSE is a 30-point questionnaire ranging from 0 to 30, where higher scores indicate better cognitive function. |
| Secondary | Change from baseline in the modified Rankin Scale (mRS) score at 6 months | At 6 months post-treatment | Unit of measure: Points. The change in the modified Rankin Scale (mRS) score from baseline to 6 months post-treatment (calculated as the 6-month score minus the baseline score). The mRS is a 7-point scale ranging from 0 to 6, where a score of 0 indicates no symptoms and 6 indicates death. Higher scores indicate worse disability. A negative value indicates an improvement (reduction in disability) from baseline. |
| Secondary | Change from baseline in the Mini-Mental State Examination (MMSE) score at 6 months | At 6 months post-treatment | Unit of measure: Points. The change in the MMSE score from baseline to 6 months post-treatment (calculated as the 6-month score minus the baseline score). The MMSE ranges from 0 to 30, with higher scores indicating better cognitive function. A negative value indicates cognitive decline. |
| Secondary | Change from baseline in the Montreal Cognitive Assessment (MoCA) Beijing version score at 6 months | At 6 months post-treatment | Unit of measure: Points. The change in the Montreal Cognitive Assessment (MoCA) Beijing version score from baseline to 6 months post-treatment (calculated as the 6-month score minus the baseline score). The MoCA Beijing version ranges from 0 to 30, with higher scores indicating better cognitive function. A negative value indicates cognitive decline. |
| Secondary | Change from baseline in the National Institutes of Health Stroke Scale (NIHSS) score at 6 months | At 6 months post-treatment | Unit of measure: Points. The change in the NIHSS score from baseline to 6 months post-treatment (calculated as the 6-month score minus the baseline score). The NIHSS ranges from 0 to 42, with higher scores indicating more severe neurological deficits. A negative value indicates neurological improvement. |
| Secondary | Change from baseline in the Lawton Activities of Daily Living Scale (Chinese 14-item revised version) score at 6 months | At 6 months post-treatment | Unit of measure: Points. The change in the Lawton Activities of Daily Living Scale score from baseline to 6 months post-treatment (calculated as the 6-month score minus the baseline score). Based on the framework of Lawton \& Brody (1969), this 14-item Chinese revised version includes 6 basic ADL and 8 instrumental ADL items. Each item is scored from 1 to 4, yielding a total score ranging from 14 to 56, with higher scores indicating worse function. A negative value indicates an improvement in daily function. |
| Secondary | Change from baseline in the Beck Depression Inventory-II (BDI-II) score at 6 months | At 6 months post-treatment | Unit of measure: Points. The change in the BDI-II score from baseline to 6 months post-treatment (calculated as the 6-month score minus the baseline score). The BDI-II ranges from 0 to 63, with higher scores indicating more severe depressive symptoms. A negative value indicates an improvement in depressive symptoms. |
| Secondary | Change from baseline in the Neuropsychiatric Inventory (NPI) score at 6 months | At 6 months post-treatment | Unit of measure: Points. The change in the NPI score from baseline to 6 months post-treatment (calculated as the 6-month score minus the baseline score). The NPI total score ranges from 0 to 144, with higher scores indicating more severe neuropsychiatric symptoms. A negative value indicates an improvement in neuropsychiatric symptoms. |
| Secondary | Change from baseline in the Global Cortical Atrophy (GCA) total score at 6 months | At 6 months post-treatment | Unit of measure: Points. The change in the Global Cortical Atrophy (GCA) total score from baseline to 6 months post-treatment (calculated as the 6-month score minus the baseline score). The GCA scale assesses cortical atrophy on cranial MRI by evaluating three regions: the frontal, parietal, and temporal lobes. Each of the three regions is scored from 0 to 3 (where 0 = no atrophy and 3 = severe atrophy). The total GCA score is the sum of the scores for these three regions, ranging from 0 to 9, with higher scores indicating more severe brain atrophy. A positive value indicates progression of brain atrophy. |
| Secondary | Change from baseline in total brain lesion volume on Magnetic Resonance Imaging (MRI) at 6 months | At 6 months post-treatment | Unit of measure: Cubic millimeters (mm³). The change in the total volume of brain lesions from baseline to 6 months post-treatment (calculated as the 6-month volume minus the baseline volume). The lesion volume is measured using T2-weighted or FLAIR sequences on cranial MRI. A positive value indicates an increase in lesion volume (worsening). |
| Secondary | All-cause mortality at 6 months | Up to 6 months post-treatment | Unit of measure: Count (number of participants). The number of participants who died from any cause during the 6-month period post-treatment. |
| Secondary | Number of participants with adverse events (AEs) at 6 months | Up to 6 months post-treatment | Unit of measure: Count (number of participants). The number of participants who experienced at least one adverse event (AE) from baseline to 6 months post-treatment. Adverse events are assessed and graded according to standard clinical safety criteria. |
| Secondary | Number of participants with serious adverse events (SAEs) at 6 months | Up to 6 months post-treatment | Unit of measure: Count (number of participants). The number of participants who experienced at least one serious adverse event (SAE) from baseline to 6 months post-treatment. SAEs are assessed and graded according to standard clinical safety criteria. |
| Other | Change from baseline in the modified Rankin Scale (mRS) score at the end of intravenous penicillin treatment | At the end of intravenous penicillin treatment (Day 12 ± 2 days) | Unit of measure: Points. The change in the mRS score from baseline to the end of intravenous penicillin treatment (calculated as the end-of-treatment score minus the baseline score). The mRS is a 7-point scale ranging from 0 to 6, with higher scores indicating worse disability. A negative value indicates an improvement in neurological function. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07904533/registered