Effects of Diet on Brain Processing
NCT02835820, Not applicable, Completed, University of Alabama at Birmingham; results first posted 2019-12-16
Trial 12
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effects of Diet on Brain Processing | ClinicalTrials.gov |
| NCT number | NCT02835820 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 17 participants, actual | ClinicalTrials.gov |
| Lead sponsor | University of Alabama at Birmingham | ClinicalTrials.gov |
| Conditions | HIV, Neurocognitive Impairment | ClinicalTrials.gov |
| Interventions | Ketogenic Diet | ClinicalTrials.gov |
| First posted | 2016-07-18 | ClinicalTrials.gov |
| Last updated | 2019-12-16 | ClinicalTrials.gov |
| Results first posted | 2019-12-16 | ClinicalTrials.gov |
| Limitations and caveats | Small sample size (pilot study), limited ability to monitor intervention fidelity, no reassessment until 12 weeks thus it is unclear as to when cognitive benefits emerged in persons randomized to the KD group. | ClinicalTrials.gov |
Registered outcomes 20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Neurocognition: Mean Score of Hopkins Verbal Learning Test (Total) at Baseline | baseline | The Hopkins Verbal Learning Test is used to measure episodic verbal learning and memory. The range of the score for the Hopkins Verbal Learning score is as follows: \> 130 superior; 120-129 high; 110-119 bright, normal; 90-109 average; 85-89 low average; 70-84 borderline mental deficit; 35-49 moderate mental deficit; 20-34 severe mental deficit; 20-25 profound mental deficit. | ClinicalTrials.gov |
| Primary | Neurocognition: Mean Score of Hopkins Verbal Learning Test (Total) at 12 Weeks Post Baseline | baseline to week 12 | The Hopkins Verbal Learning Test is used to measure episodic verbal learning and memory. The range of the score for the Hopkins Verbal Learning score is as follows: \> 130 superior; 120-129 high; 110-119 bright, normal; 90-109 average; 85-89 low average; 70-84 borderline mental deficit; 35-49 moderate mental deficit; 20-34 severe mental deficit; 20-25 profound mental deficit. | ClinicalTrials.gov |
| Primary | Neurocognition: Mean Score of Hopkins Verbal Learning Test at 18 Weeks Post Baseline | baseline to week 18 | The Hopkins Verbal Learning Test is used to measure episodic verbal learning and memory. The range of the score for the Hopkins Verbal Learning score is as follows: \> 130 superior; 120-129 high; 110-119 bright, normal; 90-109 average; 85-89 low average; 70-84 borderline mental deficit; 35-49 moderate mental deficit; 20-34 severe mental deficit; 20-25 profound mental deficit. | ClinicalTrials.gov |
| Primary | Neurocognition: Mean Score of Wechsler Adult Intelligence Scale at Baseline | baseline | The Wechsler Adult Intelligence Scale is an II test to measure intelligence and cognitive ability. The Full Scale scores are: beyond 130 place an individual in the superior or gifted range; scores between 120-129 suggest very bright; scores between 110-119 are bright normal; scores as 90-109 are average; scores of 85-89 suggest average intelligence; score of 70-84 suggests low average intelligence; score of 50 - 69 suggests borderline mental functioning; score of 50 - 69 suggests mild mental retardation; score of 35-49 suggests moderate retardation; 20 - 34 suggests severe retardation; below 20 - 25 suggests profound retardation | ClinicalTrials.gov |
| Primary | Neurocognition: Mean Score of Wechsler Adult Intelligence Scale at 12 Weeks Post Baseline | baseline to 12 weeks | The Wechsler Adult Intelligence Scale is an I! test to measure intelligence and cognitive ability. The Full Scale scores are: beyond 130 place an individual in the superior or gifted range; scores between 120-129 suggest very bright; scores between 110-119 are bright normal; scores as 90-109 are average; scores of 85-89 suggest average intelligence; score of 70-84 suggests low average intelligence; score of 50 - 69 suggests borderline mental functioning; score of 50 - 69 suggests mild mental retardation; score of 35-49 suggests moderate retardation; 20 - 34 suggests severe retardation; below 20 - 25 suggests profound retardation | ClinicalTrials.gov |
| Primary | Neurocognition: Mean Score of Wechsler Adult Intelligence Scale at 18 Weeks Post Baseline | baseline to 18 weeks | The Wechsler Adult Intelligence Scale is an I! test to measure intelligence and cognitive ability. The Full Scale scores are: beyond 130 place an individual in the superior or gifted range; scores between 120-129 suggest very bright; scores between 110-119 are bright normal; scores as 90-109 are average; scores of 85-89 suggest average intelligence; score of 70-84 suggests low average intelligence; score of 50 - 69 suggests borderline mental functioning; score of 50 - 69 suggests mild mental retardation; score of 35-49 suggests moderate retardation; 20 - 34 suggests severe retardation; below 20 - 25 suggests profound retardation | ClinicalTrials.gov |
| Primary | Neurocognition: Mean Score of Trail Making A and B at Baseline | baseline | Trails A (simple) and Trails B (alternative) neuropsychological assessments provide information on cognitive processes such as visual search, scanning, speed of processing, mental flexibility, and executive functions (i.e., memory, problem solving, verbal reasoning). It is sensitive to cognitive impairment associated with dementia. The average score for trail making is 29 seconds. Scores over 78 seconds suggest a deficit. | ClinicalTrials.gov |
| Primary | Neurocognition: Mean Score of Trail Making A and B at 12 Weeks Post Baseline | baseline to 12 weeks | Trails A (simple) and Trails B (alternative) neuropsychological assessments provide information on cognitive processes such as visual search, scanning, speed of processing, mental flexibility, and executive functions (i.e., memory, problem solving, verbal reasoning).It is sensitive to cognitive impairment associated with dementia. The average score for trail making is 29 seconds. Scores over 78 seconds suggest a deficit. | ClinicalTrials.gov |
| Primary | Neurocognition: Mean Score of Trail Making A and B at 18 Weeks Post Baseline | baseline to 18 weeks | Trails A (simple) and Trails B (alternative) neuropsychological assessments provide information on cognitive processes such as visual search, scanning, speed of processing, mental flexibility, and executive functions (i.e., memory, problem solving, verbal reasoning). It is sensitive to cognitive impairment associated with dementia. The average score for trail making is 29 seconds. Scores over 78 seconds suggest a deficit. | ClinicalTrials.gov |
| Primary | Neurocognition: Mean Score of Stroop Test at Baseline | baseline | The score of greater than is considered normal; a score of 40 or less is considered "low" whereas a score greater than 40 is considered "normal". Stroop test is named after the instrument developer, John Stroop. The instrument title is not an acronym. | ClinicalTrials.gov |
| Primary | Neurocognition: Mean Score of Stroop Test at 12 Weeks Post Baseline | Baseline to 12 weeks | The score of greater than is considered normal; a score of 40 or less is considered "low" whereas a score greater than 40 is considered "normal". Stroop test is named after the instrument developer, John Stroop. The instrument title is not an acronym. | ClinicalTrials.gov |
| Primary | Neurocognition: Mean Score of Stroop Test at 18 Weeks Post Baseline | baseline to 18 weeks | The STROOP measures brain damage. The score of greater than is considered normal; a score of 40 or less is considered "low" whereas a score greater than 40 is considered "normal". Stroop test is named after the instrument developer, John Stroop. The instrument title is not an acronym. | ClinicalTrials.gov |
| Primary | Cardiometabolic Markers: Mean Fasting Glucose Measures at Baseline | baseline | A fasting blood sugar level less than 100mg/dl is normal. A fasting blood sugar level of 100- 126mg/dl is considered prediabetic. 126mg/dl or greater suggests diabetes | ClinicalTrials.gov |
| Primary | Cardiometabolic Markers: Mean Fasting Glucose Measures at 12 Weeks Post Baseline | baseline to 12 weeks | A fasting blood sugar level less than 100mg/dl is normal. A fasting blood sugar level of 100- 126mg/dl is considered prediabetic. 126mg/dl or greater suggests diabetes | ClinicalTrials.gov |
| Primary | Cardiometabolic Markers: Mean Markers of Inflammation (C-reactive Protein) Measures at Baseline | baseline | C-reactive protein (CRP) , a protein in the blood, indicates inflammation, specifically in the heart.. CRP levels rise with inflammation. A CRP concentration of below 1.0 mg/L indicates low risk; 1.0 to 3.0 mg/L suggests an average risk. Greater than 3.0 mg/L suggests a high risk. | ClinicalTrials.gov |
| Primary | Cardiometabolic Markers: Mean Markers of Inflammation (C-reactive Protein) Measures at 12 Weeks Post Baseline | baseline to 12 weeks | C-reactive protein (CRP) , a protein in the blood, indicates inflammation, specifically in the heart.. CRP levels rise with inflammation. A CRP concentration of below 1.0 mg/L indicates low risk; 1.0 to 3.0 mg/L suggests an average risk. Greater than 3.0 mg/L suggests a high risk. | ClinicalTrials.gov |
| Primary | Tumor Necrosis Factor Alpha (TNF or TNF-α) | baseline | Tumor Necrosis Factor Alpha (TNF or TNF-α) is a major pro-inflammatory cytokine involved in inflammatory events. Being one of the most important pro-inflammatory cytokines, TNF-α participates in vasodilatation and edema formation, and leukocyte adhesion to epithelium through expression of adhesion molecules; it regulates blood coagulation, and also contributes to oxidative stress in sites of inflammation. | ClinicalTrials.gov |
| Primary | Tumor Necrosis Factor (TNF or TNF-α) | baseline to week 12 | Tumor Necrosis Factor Alpha (TNF or TNF-α) is a major pro-inflammatory cytokine involved in inflammatory events. Being one of the most important pro-inflammatory cytokines, TNF-α participates in vasodilatation and edema formation, and leukocyte adhesion to epithelium through expression of adhesion molecules; it regulates blood coagulation, and also contributes to oxidative stress in sites of inflammation. | ClinicalTrials.gov |
| Secondary | Neural Activity: Presence or Absence of Impaired Bloodflow in the Brain at Baseline as Determined by a Functional MRI | baseline | Functional MRI is used to determine blood flow in the brain. Absence of blood flow impairment will be recorded as '0' and impairment will be recorded as '1' | ClinicalTrials.gov |
| Secondary | Neural Activity: Presence or Absence of Impaired Bloodflow in the Brain at 12 Weeks Post Baseline as Determined by a Functional MRI | Baseline to 12 weeks | Functional MRI is used to determine blood flow in the brain. Absence of blood flow impairment will be recorded as '0' and impairment will be recorded as '1' | ClinicalTrials.gov |
Outcomes 20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Neurocognition: Mean Score of Hopkins Verbal Learning Test (Total) at Baseline | baseline | Three participants from the PCD ineligible due to baseline screen fail. | score on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Neurocognition: Mean Score of Hopkins Verbal Learning Test (Total) at 12 Weeks Post Baseline | baseline to week 12 | Three PCD participants ineligible due to baseline screen fail. | score on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Neurocognition: Mean Score of Hopkins Verbal Learning Test at 18 Weeks Post Baseline | baseline to week 18 | Three PCD participants ineligible due to baseline screen fail. | score on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Neurocognition: Mean Score of Wechsler Adult Intelligence Scale at Baseline | baseline | Three PCD participants ineligible due to baseline screen fail. | score on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Neurocognition: Mean Score of Wechsler Adult Intelligence Scale at 12 Weeks Post Baseline | baseline to 12 weeks | Three PCD participants ineligible due to baseline screen fail. | score on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Neurocognition: Mean Score of Wechsler Adult Intelligence Scale at 18 Weeks Post Baseline | baseline to 18 weeks | Three PCD participants ineligible due to baseline screen fail. | score on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Neurocognition: Mean Score of Trail Making A and B at Baseline | baseline | Three PCD participants ineligible due to baseline screen fail. | Seconds to complete | MEAN | ClinicalTrials.gov |
| PRIMARY | Neurocognition: Mean Score of Trail Making A and B at 12 Weeks Post Baseline | baseline to 12 weeks | Three PCD participants ineligible due to baseline screen fail. | Seconds to complete | MEAN | ClinicalTrials.gov |
| PRIMARY | Neurocognition: Mean Score of Trail Making A and B at 18 Weeks Post Baseline | baseline to 18 weeks | Three PCD participants ineligible due to baseline screen fail. | Seconds to complete | MEAN | ClinicalTrials.gov |
| PRIMARY | Neurocognition: Mean Score of Stroop Test at Baseline | baseline | Three PCD participants ineligible due to baseline screen fail. | Number of correctly identified items | MEAN | ClinicalTrials.gov |
| PRIMARY | Neurocognition: Mean Score of Stroop Test at 12 Weeks Post Baseline | Baseline to 12 weeks | Three PCD participants ineligible due to baseline screen fail. | Number of correctly identified items | MEAN | ClinicalTrials.gov |
| PRIMARY | Neurocognition: Mean Score of Stroop Test at 18 Weeks Post Baseline | baseline to 18 weeks | Three PCD participants ineligible due to baseline screen fail. | Number of correctly identified items | MEAN | ClinicalTrials.gov |
| PRIMARY | Cardiometabolic Markers: Mean Fasting Glucose Measures at Baseline | baseline | Three PCD participants were ineligible due to baseline screen fail. | mg/dL | MEAN | ClinicalTrials.gov |
| PRIMARY | Cardiometabolic Markers: Mean Fasting Glucose Measures at 12 Weeks Post Baseline | baseline to 12 weeks | Three PCD participants were ineligible due to baseline screen fail. | mg/dL | MEAN | ClinicalTrials.gov |
| PRIMARY | Cardiometabolic Markers: Mean Markers of Inflammation (C-reactive Protein) Measures at Baseline | baseline | Three PCD participants were ineligible due to baseline screen fail. | mg/L | MEAN | ClinicalTrials.gov |
| PRIMARY | Cardiometabolic Markers: Mean Markers of Inflammation (C-reactive Protein) Measures at 12 Weeks Post Baseline | baseline to 12 weeks | Three PCD participants were ineligible due to baseline screen fail. | mg/L | MEAN | ClinicalTrials.gov |
| PRIMARY | Tumor Necrosis Factor Alpha (TNF or TNF-α) | baseline | Three PCD participants were ineligible due to baseline screen fail. | pg/mL | MEAN | ClinicalTrials.gov |
| PRIMARY | Tumor Necrosis Factor (TNF or TNF-α) | baseline to week 12 | pg/mL | MEAN | ClinicalTrials.gov | |
| SECONDARY | Neural Activity: Presence or Absence of Impaired Bloodflow in the Brain at Baseline as Determined by a Functional MRI | baseline | Those randomized to intervention group at baseline without MRI contraindications | Participants | COUNT_OF_PARTICIPANTS | ClinicalTrials.gov |
| SECONDARY | Neural Activity: Presence or Absence of Impaired Bloodflow in the Brain at 12 Weeks Post Baseline as Determined by a Functional MRI | Baseline to 12 weeks | Intervention group as randomized. | Participants | COUNT_OF_PARTICIPANTS | ClinicalTrials.gov |
Results by group 40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Neurocognition: Mean Score of Hopkins Verbal Learning Test (Total) at Baseline | Ketogenic Diet Group | 29.4 | Standard Deviation 9.8 | score on a scale | ClinicalTrials.gov | |
| Neurocognition: Mean Score of Hopkins Verbal Learning Test (Total) at Baseline | Participant Choice Diet | 31.1 | Standard Deviation 8.6 | score on a scale | ClinicalTrials.gov | |
| Neurocognition: Mean Score of Hopkins Verbal Learning Test (Total) at 12 Weeks Post Baseline | Ketogenic Diet Group | 35.3 | Standard Deviation 9.6 | score on a scale | ClinicalTrials.gov | |
| Neurocognition: Mean Score of Hopkins Verbal Learning Test (Total) at 12 Weeks Post Baseline | Participant Choice Diet | 34.9 | Standard Deviation 12.6 | score on a scale | ClinicalTrials.gov | |
| Neurocognition: Mean Score of Hopkins Verbal Learning Test at 18 Weeks Post Baseline | Ketogenic Diet Group | 39.6 | Standard Deviation 9.1 | score on a scale | ClinicalTrials.gov | |
| Neurocognition: Mean Score of Hopkins Verbal Learning Test at 18 Weeks Post Baseline | Participant Choice Diet | 36.6 | Standard Deviation 11.7 | score on a scale | ClinicalTrials.gov | |
| Neurocognition: Mean Score of Wechsler Adult Intelligence Scale at Baseline | Ketogenic Diet Group | 46.1 | Standard Deviation 9.3 | score on a scale | ClinicalTrials.gov | |
| Neurocognition: Mean Score of Wechsler Adult Intelligence Scale at Baseline | Participant Choice Diet | 46.0 | Standard Deviation 7.5 | score on a scale | ClinicalTrials.gov | |
| Neurocognition: Mean Score of Wechsler Adult Intelligence Scale at 12 Weeks Post Baseline | Ketogenic Diet Group | 46.7 | Standard Deviation 8.1 | score on a scale | ClinicalTrials.gov | |
| Neurocognition: Mean Score of Wechsler Adult Intelligence Scale at 12 Weeks Post Baseline | Participant Choice Diet | 46.1 | Standard Deviation 9.5 | score on a scale | ClinicalTrials.gov | |
| Neurocognition: Mean Score of Wechsler Adult Intelligence Scale at 18 Weeks Post Baseline | Ketogenic Diet Group | 52.0 | Standard Deviation 10.8 | score on a scale | ClinicalTrials.gov | |
| Neurocognition: Mean Score of Wechsler Adult Intelligence Scale at 18 Weeks Post Baseline | Participant Choice Diet | 44.7 | Standard Deviation 10.2 | score on a scale | ClinicalTrials.gov | |
| Neurocognition: Mean Score of Trail Making A and B at Baseline | Ketogenic Diet Group | 41.6 | Standard Deviation 17.0 | Seconds to complete | ClinicalTrials.gov | |
| Neurocognition: Mean Score of Trail Making A and B at Baseline | Participant Choice Diet | 50.0 | Standard Deviation 7.7 | Seconds to complete | ClinicalTrials.gov | |
| Neurocognition: Mean Score of Trail Making A and B at 12 Weeks Post Baseline | Ketogenic Diet Group | 44.6 | Standard Deviation 17.6 | Seconds to complete | ClinicalTrials.gov | |
| Neurocognition: Mean Score of Trail Making A and B at 12 Weeks Post Baseline | Participant Choice Diet | 44.3 | Standard Deviation 8.3 | Seconds to complete | ClinicalTrials.gov | |
| Neurocognition: Mean Score of Trail Making A and B at 18 Weeks Post Baseline | Ketogenic Diet Group | 40.1 | Standard Deviation 16.2 | Seconds to complete | ClinicalTrials.gov | |
| Neurocognition: Mean Score of Trail Making A and B at 18 Weeks Post Baseline | Participant Choice Diet | 44.1 | Standard Deviation 11.9 | Seconds to complete | ClinicalTrials.gov | |
| Neurocognition: Mean Score of Stroop Test at Baseline | Ketogenic Diet Group | 36.3 | Standard Deviation 6.8 | Number of correctly identified items | ClinicalTrials.gov | |
| Neurocognition: Mean Score of Stroop Test at Baseline | Participant Choice Diet | 36.0 | Standard Deviation 6.0 | Number of correctly identified items | ClinicalTrials.gov |
Participant flow 8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Ketogenic Diet Group | 7 | ClinicalTrials.gov | |
| Overall Study | STARTED | Participant Choice Diet | 10 | ClinicalTrials.gov | |
| Overall Study | Baseline Screen (OGTT) | Ketogenic Diet Group | 7 | ClinicalTrials.gov | |
| Overall Study | Baseline Screen (OGTT) | Participant Choice Diet | 7 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Ketogenic Diet Group | 7 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Participant Choice Diet | 7 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Ketogenic Diet Group | 0 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Participant Choice Diet | 3 | ClinicalTrials.gov |
Adverse events 2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|---|---|---|---|---|---|---|
| other | Hospitalization | Respiratory, thoracic and mediastinal disorders | Ketogenic Diet Group | 1 | 7 | 1 | ClinicalTrials.gov |
| other | Hospitalization | Respiratory, thoracic and mediastinal disorders | Participant Choice Diet | 0 | 7 | 0 | ClinicalTrials.gov |
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Ketogenic Diet Group | 0 | 7 | ClinicalTrials.gov |
| Total, all-cause mortality | Participant Choice Diet | 0 | 7 | ClinicalTrials.gov |
| Total, other adverse events | Ketogenic Diet Group | 1 | 7 | ClinicalTrials.gov |
| Total, other adverse events | Participant Choice Diet | 0 | 7 | ClinicalTrials.gov |
| Total, serious adverse events | Ketogenic Diet Group | 0 | 7 | ClinicalTrials.gov |
| Total, serious adverse events | Participant Choice Diet | 0 | 7 | ClinicalTrials.gov |
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 31725105 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ketogenic Diet Group vs Participant Choice Diet: deaths from any cause | Trial comparisons |
| Ketogenic Diet Group vs Participant Choice Diet: serious adverse events | Trial comparisons |
Tests 4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
| Verbal Learning | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)