Minocycline for the Treatment of Decreased Mental Function in HIV-Infected Adults
NCT00361257, Phase 2, Terminated, Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections; results first posted 2011-07-26
Trial 12
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Minocycline for the Treatment of Decreased Mental Function in HIV-Infected Adults | ClinicalTrials.gov |
| NCT number | NCT00361257 | ClinicalTrials.gov |
| Status | Terminated | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 107 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections | ClinicalTrials.gov |
| Conditions | HIV Infections | ClinicalTrials.gov |
| Interventions | Minocycline, Placebo (Tetracycline) | ClinicalTrials.gov |
| First posted | 2006-08-08 | ClinicalTrials.gov |
| Last updated | 2016-02-05 | ClinicalTrials.gov |
| Results first posted | 2011-07-26 | ClinicalTrials.gov |
| Limitations and caveats | Originally, 100 participants were expected to enroll. As of the early termination notice, 107 participants were randomized, yet not all subjects could complete the 24 week assessment. | ClinicalTrials.gov |
Registered outcomes 24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Cognitive Performance Compared to Baseline | At baseline and week 24 | Th cognitive performance is measured by NPZ-8. NPZ-8 is defined as the average of age and education adjusted z-scores of eight neuropsychological tests subcomponents in the neuropsychological test battery. These eight tests are: 1. Grooved Pegboard Dominant Hand (GPD) 2. Grooved Pegboard Non-dominant hand (GPN) 3. Choice Reaction Time (CRT) 4. Sequential Reaction Time (QRT) 5. Timed Gait (TIG) 6. Trail Making Part A (TMA) 7. Trail Making Part B (TMB) 8. Symbol Digit (SYD) The primary outcome is NPZ-8 score at week24 - NPZ-8 score at baseline. | ClinicalTrials.gov |
| Secondary | Change in Global Deficit Z-Score (GDS) | At baseline and week 24 | GDS on the test battery is the simple average of all 14 individual deficit scores in the test battery, including Time Gait, Grooved Pegboard Test for the dominant and non-dominant hands, Trail Making Test parts A and B, Symbol Digit Test, simple and sequential reaction time - CalCAP, Hopkins Verbal Learning Test (Revised)- Learning, Delayed Recall and Recognition trials, and Stroop Color Interference Test-color, word, and interference tasks. The outcome is the 24 week change of GDS Z-score (24 week-baseline). | ClinicalTrials.gov |
| Secondary | Change in Investigator's Clinical Global Impression Score (ICGIS) | At week 24 | Clinicians were asked to rate their overall impression about the clinical improvement or worsening of his/her study participants. They can choose from the following 7 levels: (0) No Change, (1) Mild Improvement, (2) Moderate Improvement, (3) Marked Improvement, (4) Mild Worsening, (5) Moderate Worsening, and (6) Marked Worsening. For the analysis, we simplified the outcome into the following 3 levels: (0) worsened, (1) No Change, and (2) Improved. | ClinicalTrials.gov |
| Secondary | Change in Cognitive Gross Motor Function Domain Z-Score | At baseline and week 24 | The cognitive gross motor function is a age and education adjusted z score of Timed Gait (TIG). The outcome is the 24 week change of cognitive gross motor function domain z-scores (week 24-baseline). | ClinicalTrials.gov |
| Secondary | Change in Fine Motor Function Domain Z-Score | At baseline and week 24 | The fine motor function domain score is an average of age, sex, education, and African-American ethnicity adjusted z scores of Grooved Pegboard Dominant Hand (GPD) and Grooved Pegboard Non-dominant hand (GPN). The outcome is a 24 week change of the fine motor function domain z-score (week 24-baseline). | ClinicalTrials.gov |
| Secondary | Change in Psychomotor Function Domain Z-Score | At baseline and week 24 | The psychomotor function domain score us the average of age, sex, education, and African-American ethnicity adjusted z scores of Trail Making Part A (TMA) and Trail Making Part B (TMB). The outcome is the 24 week change of psychomotor function domain z-scores (week24-baseline). | ClinicalTrials.gov |
| Secondary | Change in Fine Motor/Nonverbal Function Domain Z-Score | At baseline and week 24 | The fine motor/nonverbal function domain score is a age and education adjusted z score of Symbol Digit Test (SYD) The outcome is the 24 change of fine motor/nonverbal function domain z-score (week 24-baseline). | ClinicalTrials.gov |
| Secondary | Change in Information Processing Function Domain Z-Score | At baseline and week 24 | The information processing function domain score is the average of age and education adjusted z scores of simple and sequential reaction time - CalCAP. The outcome is the 24 week change of information processing function domain z-scores (week 24-baseline). | ClinicalTrials.gov |
| Secondary | Change in Verbal Memory Domain Z-Score | At baseline and week 24 | The verbal memory domain score is the average of age and education adjusted z scores of Hopkins Verbal Learning Test- Revised, Learning and Delayed Recall. The outcome is the 24 week change of verbal memory domain z-scores (week 24-baseline). | ClinicalTrials.gov |
| Secondary | Change in Frontal Systems Function Domain Z-Score | At baseline and week 24 | The frontal systems function domain score is the average of age and education adjusted z scores of Stroop Color Interference Test (CTP) and interference task (STP). The outcome is the 24 week change of frontal systems function domain z-score (week 24-baseline). | ClinicalTrials.gov |
| Secondary | Change in Karnofsky Performance Score | At baseline and week 24 | The original Karnofsky performance score is 11 level score which ranges between 0 to 100. The score 100 means normal and 0 means death; therefore, higher score means higher ability to perform daily tasks. For the analysis, a new dichotomous variable (no change/worse vs. better at 24 weeks compared to baseline) was created. | ClinicalTrials.gov |
| Secondary | Changes in Cluster of Differentiation 4 (CD4) Cell Counts (24 Weeks) | At baseline and weeks 24 | The outcome was the 24 week change in CD4 cell count (week 24-baseline). | ClinicalTrials.gov |
| Secondary | Changes in Cluster of Differentiation 8 (CD8) Cell Counts (24 Weeks) | At baseline and week 24 | The outcome was the 24 week change of CD8 cell counts (week 24-baseline). | ClinicalTrials.gov |
| Secondary | Number of Participants With Grade 2 or Higher Toxicity and/or Signs and Symptoms | Throughout study up to week 48 | Grade or higher means that adverse events were moderate, severe, or life-threatening, or death. Grade 2 or higher adverse events are lised in the Adverse Event section. | ClinicalTrials.gov |
| Secondary | Change of HIV Plasma RiboNucleic Acid (RNA) Viral Load | At baseline and week 24 | The original scale of HIV RNA viral load is between 30 copies/mL to infinitive. The minimum score of 30 is the lowest detectable value. The summary table categorized this continuous value to a dichotomous variable (\<30 copies/mL and \>= 30 copies/mL). | ClinicalTrials.gov |
| Secondary | Changes in Instrumental Activities of Daily Living Questionnaire | At baseline and week 24 | The Instrumental Activities of Daily Living (IADL) questionnaire is designed to learn more about how subjects are able to perform common tasks. There are 16 common tasks. For each task, if the score at the time of evaluation is worse than the best in the past, an indicator of 1 is given. Otherwise, the indicator is 0. The overall IADL score is a sum of 16 indicators divided by 16; therefore, the range is between 0 and 1 and the lower score is better. The 24-week change of IADL score was changed into a categorical variable (no change/worse vs. better) at week 24 compare to baseline. | ClinicalTrials.gov |
| Secondary | Changes in Medication Management Test (Modified) | At baseline and weeks 24 | The medication management test (modified) is designed to assess participants' medication management ability and their own medications and management. It's the number of how many times participants correctly answered 16 questions. The score ranges between 0 and 16, and higher score indicates better medication management. | ClinicalTrials.gov |
| Secondary | Changes in Protein Markers of Oxidative Stress (Unit = Counts Per Second Only) | At pre-entry and Week 24 | Protein marker of oxidative stress (Ceramides, Monohexosylceramides, Dihydro Glycosyl Galceramides, and Dihexosylceramides). For all markers, the outcome is the 24 week change (week 24-baseline). | ClinicalTrials.gov |
| Secondary | Changes in Markers of Oxidative Stress and Immune Activation (Unit=pg/mL Only) | At pre-entry and Week 24 | Protein markers of oxidative stress (Protein carbonyls) and markers of immune activation (TNF-a, IL-6,CXCL8, Hepatocyte growth factor, Osteopontin, sFAS, sFAS ligand, and CXCL12). For all markers, the outcome is the 24 week change (week 24-baseline). | ClinicalTrials.gov |
| Secondary | Changes in Markers of Oxidative Stress (Unit = Pixels/mm2 Only) | At pre-entry and Week 24 | Protein marker of oxidative stress (Neurofilament heavy polypeptide). The outcome is the 24 week change (week 24-baseline). | ClinicalTrials.gov |
Outcomes 24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Change in Cognitive Performance Compared to Baseline | At baseline and week 24 | The descriptive statistics above were based on the observed data; however, the statistical analysis was conducted by the ITT analysis and the missing outcomes at week 24 were imputed based on multiple regression imputations. | z-score | MEAN | ClinicalTrials.gov |
| SECONDARY | Change in Global Deficit Z-Score (GDS) | At baseline and week 24 | The analysis was based on the observed data. | z-score | MEAN | ClinicalTrials.gov |
| SECONDARY | Change in Investigator's Clinical Global Impression Score (ICGIS) | At week 24 | The analysis was based on observed data. | participants | NUMBER | ClinicalTrials.gov |
| SECONDARY | Change in Cognitive Gross Motor Function Domain Z-Score | At baseline and week 24 | The analysis was based on the observed data. | z-score | MEAN | ClinicalTrials.gov |
| SECONDARY | Change in Fine Motor Function Domain Z-Score | At baseline and week 24 | The analysis was based on observed data. | z-score | MEAN | ClinicalTrials.gov |
| SECONDARY | Change in Psychomotor Function Domain Z-Score | At baseline and week 24 | The analysis was based on observed data. | z-score | MEAN | ClinicalTrials.gov |
| SECONDARY | Change in Fine Motor/Nonverbal Function Domain Z-Score | At baseline and week 24 | The analysis was based on observed data. | z-score | MEAN | ClinicalTrials.gov |
| SECONDARY | Change in Information Processing Function Domain Z-Score | At baseline and week 24 | The analysis was based on observed data. | z-score | MEAN | ClinicalTrials.gov |
| SECONDARY | Change in Verbal Memory Domain Z-Score | At baseline and week 24 | The analysis was based on observed data. | z-score | MEAN | ClinicalTrials.gov |
| SECONDARY | Change in Frontal Systems Function Domain Z-Score | At baseline and week 24 | The analysis was based on observed data. | z-score | MEAN | ClinicalTrials.gov |
| SECONDARY | Change in Karnofsky Performance Score | At baseline and week 24 | The analysis was based on observed data. | participants | NUMBER | ClinicalTrials.gov |
| SECONDARY | Changes in Cluster of Differentiation 4 (CD4) Cell Counts (24 Weeks) | At baseline and weeks 24 | The analysis was based on observed data. | cells/mm^3 | MEAN | ClinicalTrials.gov |
| SECONDARY | Changes in Cluster of Differentiation 8 (CD8) Cell Counts (24 Weeks) | At baseline and week 24 | The analysis was based on observed data. | cells/mm^3 | MEAN | ClinicalTrials.gov |
| SECONDARY | Number of Participants With Grade 2 or Higher Toxicity and/or Signs and Symptoms | Throughout study up to week 48 | The analysis includes all randomized participants. A total of 37 minocycline and 38 placebo participants reported Grade 2 or higher toxicity and/or signs and symptoms during 48 weeks. | participants with an event | NUMBER | ClinicalTrials.gov |
| SECONDARY | Change of HIV Plasma RiboNucleic Acid (RNA) Viral Load | At baseline and week 24 | The summary statistics were based on observed data. No statistical analysis was conducted. | participants | NUMBER | ClinicalTrials.gov |
| SECONDARY | Changes in Instrumental Activities of Daily Living Questionnaire | At baseline and week 24 | The analysis was based on observed data. | participants | NUMBER | ClinicalTrials.gov |
| SECONDARY | Changes in Medication Management Test (Modified) | At baseline and weeks 24 | The analysis was based on observed data. | scores on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Changes in Protein Markers of Oxidative Stress (Unit = Counts Per Second Only) | At pre-entry and Week 24 | Participants who were willing to receive the lumber punctures at week 0 and 24. | counts per second | MEDIAN | ClinicalTrials.gov |
| SECONDARY | Changes in Markers of Oxidative Stress and Immune Activation (Unit=pg/mL Only) | At pre-entry and Week 24 | Participants who were willing to receive the lumber punctures at week 0 and 24. | pg/mL | MEDIAN | ClinicalTrials.gov |
| SECONDARY | Changes in Markers of Oxidative Stress (Unit = Pixels/mm2 Only) | At pre-entry and Week 24 | Participants who were willing to receive the lumber punctures at week 0 and 24. | Pixels/mm^2 | MEDIAN | ClinicalTrials.gov |
Results by group 100
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Change in Cognitive Performance Compared to Baseline | Minocycline | 0.12 | Standard Deviation 0.71 | z-score | ClinicalTrials.gov | |
| Change in Cognitive Performance Compared to Baseline | Matching Placebo | 0.17 | Standard Deviation 0.67 | z-score | ClinicalTrials.gov | |
| Change in Global Deficit Z-Score (GDS) | Minocycline | 0.11 | Standard Deviation 0.58 | z-score | ClinicalTrials.gov | |
| Change in Global Deficit Z-Score (GDS) | Matching Placebo | 0.09 | Standard Deviation 0.51 | z-score | ClinicalTrials.gov | |
| Change in Investigator's Clinical Global Impression Score (ICGIS) | Minocycline | Worsened | 4 | participants | ClinicalTrials.gov | |
| Change in Investigator's Clinical Global Impression Score (ICGIS) | Matching Placebo | Worsened | 2 | participants | ClinicalTrials.gov | |
| Change in Investigator's Clinical Global Impression Score (ICGIS) | Minocycline | No Change | 28 | participants | ClinicalTrials.gov | |
| Change in Investigator's Clinical Global Impression Score (ICGIS) | Matching Placebo | No Change | 31 | participants | ClinicalTrials.gov | |
| Change in Investigator's Clinical Global Impression Score (ICGIS) | Minocycline | Improved | 9 | participants | ClinicalTrials.gov | |
| Change in Investigator's Clinical Global Impression Score (ICGIS) | Matching Placebo | Improved | 12 | participants | ClinicalTrials.gov | |
| Change in Cognitive Gross Motor Function Domain Z-Score | Minocycline | 0.22 | Standard Deviation 1.61 | z-score | ClinicalTrials.gov | |
| Change in Cognitive Gross Motor Function Domain Z-Score | Matching Placebo | 0.08 | Standard Deviation 2.68 | z-score | ClinicalTrials.gov | |
| Change in Fine Motor Function Domain Z-Score | Minocycline | 0.27 | Standard Deviation 0.84 | z-score | ClinicalTrials.gov | |
| Change in Fine Motor Function Domain Z-Score | Matching Placebo | 0.05 | Standard Deviation 0.61 | z-score | ClinicalTrials.gov | |
| Change in Psychomotor Function Domain Z-Score | Minocycline | 0.07 | Standard Deviation 0.66 | z-score | ClinicalTrials.gov | |
| Change in Psychomotor Function Domain Z-Score | Matching Placebo | 0.15 | Standard Deviation 0.88 | z-score | ClinicalTrials.gov | |
| Change in Fine Motor/Nonverbal Function Domain Z-Score | Minocycline | -0.15 | Standard Deviation 0.76 | z-score | ClinicalTrials.gov | |
| Change in Fine Motor/Nonverbal Function Domain Z-Score | Matching Placebo | -0.07 | Standard Deviation 0.92 | z-score | ClinicalTrials.gov | |
| Change in Information Processing Function Domain Z-Score | Minocycline | 0.14 | Standard Deviation 1.65 | z-score | ClinicalTrials.gov | |
| Change in Information Processing Function Domain Z-Score | Matching Placebo | 0.20 | Standard Deviation 1.14 | z-score | ClinicalTrials.gov |
Participant flow 12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Step 1: Minocycline vs. Placebo | STARTED | Minocycline | 52 | ClinicalTrials.gov | |
| Step 1: Minocycline vs. Placebo | STARTED | Matching Placebo | 55 | ClinicalTrials.gov | |
| Step 1: Minocycline vs. Placebo | COMPLETED | Minocycline | 40 | ClinicalTrials.gov | |
| Step 1: Minocycline vs. Placebo | COMPLETED | Matching Placebo | 43 | ClinicalTrials.gov | |
| Step 1: Minocycline vs. Placebo | NOT COMPLETED | Minocycline | 12 | ClinicalTrials.gov | |
| Step 1: Minocycline vs. Placebo | NOT COMPLETED | Matching Placebo | 12 | ClinicalTrials.gov | |
| Step 2: Minocycline(Open Label) for All | STARTED | Minocycline | 28 | ClinicalTrials.gov | |
| Step 2: Minocycline(Open Label) for All | STARTED | Matching Placebo | 34 | ClinicalTrials.gov | |
| Step 2: Minocycline(Open Label) for All | COMPLETED | Minocycline | 13 | ClinicalTrials.gov | |
| Step 2: Minocycline(Open Label) for All | COMPLETED | Matching Placebo | 19 | ClinicalTrials.gov | |
| Step 2: Minocycline(Open Label) for All | NOT COMPLETED | Minocycline | 15 | ClinicalTrials.gov | |
| Step 2: Minocycline(Open Label) for All | NOT COMPLETED | Matching Placebo | 15 | ClinicalTrials.gov |
Adverse events 34
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 | Fatigue | General disorders | Minocycline | 4 | 52 | 4 | ClinicalTrials.gov |
| other | Fatigue | General disorders | Matching Placebo | 3 | 55 | 3 | ClinicalTrials.gov |
| other | Pain | General disorders | Minocycline | 5 | 52 | 9 | ClinicalTrials.gov |
| other | Pain | General disorders | Matching Placebo | 9 | 55 | 9 | ClinicalTrials.gov |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Minocycline | 2 | 52 | 2 | ClinicalTrials.gov |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Matching Placebo | 4 | 55 | 4 | ClinicalTrials.gov |
| other | Sob | General disorders | Minocycline | 0 | 52 | 0 | ClinicalTrials.gov |
| other | Sob | General disorders | Matching Placebo | 4 | 55 | 4 | ClinicalTrials.gov |
| other | Diarrhea/Loose | Gastrointestinal disorders | Minocycline | 5 | 52 | 5 | ClinicalTrials.gov |
| other | Diarrhea/Loose | Gastrointestinal disorders | Matching Placebo | 3 | 55 | 3 | ClinicalTrials.gov |
| other | Nausea | Gastrointestinal disorders | Minocycline | 2 | 52 | 2 | ClinicalTrials.gov |
| other | Nausea | Gastrointestinal disorders | Matching Placebo | 4 | 55 | 4 | ClinicalTrials.gov |
| other | Headache | General disorders | Minocycline | 1 | 52 | 1 | ClinicalTrials.gov |
| other | Headache | General disorders | Matching Placebo | 7 | 55 | 7 | ClinicalTrials.gov |
| serious | Blood amylase increased | Blood and lymphatic system disorders | Minocycline | 1 | 52 | 1 | ClinicalTrials.gov |
| serious | Blood amylase increased | Blood and lymphatic system disorders | Matching Placebo | 0 | 55 | 0 | ClinicalTrials.gov |
| serious | Vocal cord paralysis | Nervous system disorders | Minocycline | 1 | 52 | 1 | ClinicalTrials.gov |
| serious | Vocal cord paralysis | Nervous system disorders | Matching Placebo | 0 | 55 | 0 | ClinicalTrials.gov |
| serious | Renal failure | Renal and urinary disorders | Minocycline | 0 | 52 | 0 | ClinicalTrials.gov |
| serious | Renal failure | Renal and urinary disorders | Matching Placebo | 1 | 55 | 1 | ClinicalTrials.gov |
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Minocycline | ClinicalTrials.gov | ||
| Total, all-cause mortality | Matching Placebo | ClinicalTrials.gov | ||
| Total, other adverse events | Minocycline | 18 | 52 | ClinicalTrials.gov |
| Total, other adverse events | Matching Placebo | 34 | 55 | ClinicalTrials.gov |
| Total, serious adverse events | Minocycline | 7 | 52 | ClinicalTrials.gov |
| Total, serious adverse events | Matching Placebo | 3 | 55 | ClinicalTrials.gov |
Papers 5
The papers the trial lists on ClinicalTrials.gov.
Grants 1
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 |
|---|---|---|---|---|---|---|
| U01AI068636 | AIDS Clinical Trials Group Network | KURITZKES, DANIEL R. | SOCIAL AND SCIENTIFIC SYSTEMS, INC. | NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES | 2006 to 2010 | NIH RePORTER |
Trial comparisons 1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Minocycline vs Matching Placebo: serious adverse events | Trial comparisons |
Tests 6
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 |
|---|---|---|
| Choice Reaction Time | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary 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)