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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01NS094257-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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Forty-five subjects receiving no dietary therapy with a proven G1D diagnosis will be enrolled. To evaluate the effect of C7 supplementation of a regular diet on a EEG activity in addition to IQ, language, working memory, processing speed, emotional and behavioral functioning, ataxia, and other neuropsychological and neurological performance indices in children and adults genetically diagnosed with G1D receiving a regular diet at enrollment.
This is an open-label, single arm trial of orally-administered C7 in G1D. Subjects will replace a fixed percentage of their daily caloric intake (based on the results of Protocol 1) with C7 for 6 months, undergo full evaluation and discontinuation of treatment at a 6 month visit, and return for an off-treatment follow up visit 3 months after C7 oil discontinuation, for total duration of participation of 9 months. Subjects will undergo treatment initiation on a 24-hour inpatient basis. During that 24-hr inpatient treatment initiation, subjects will have continuous EEG both to monitor for real-time seizure activity (for safety) and to determine EEG changes (secondary outcome) before, during, and after treatment initiation. Subjects will undergo clinical evaluation, comprehensive blood work, ataxia scale rating, EEG, and neuropsychological testing at baseline, 6 months, and 9 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triheptanoin | Experimental | This is a single arm study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triheptanoin | Drug | . Triheptanoin will be taken 4 times per day (approximately every 6 hours: prior to breakfast, lunch and dinner and a mid-afternoon snack) by mouth. It is dosed 4 times per day, divided evenly. |
| Measure | Description | Time Frame |
|---|---|---|
| Neuropsychological Score of Sustained Attention | Sustained attention was evaluated using a subtest of Conners' Kiddie Continuous Performance Test Second Edition (K-CPT 2): CPT-Hit Reaction Time Block Change. CPT HRT BC indicates the change in mean response speed as the administration of the test progresses in blocks. A decrease in CPT HRT BC indicates a decrease in reaction time, which means the participant's information processing efficiency increases, and an improvement in sustained attention is noted. The number of participants that showed a decrease in the CPT HRT BC score after 6 months of treatment as compared to baseline is noted here. | Change post 6 months of treatment |
| Neuropsychological Score of Sustained Attention | Sustained attention was evaluated using a subtest of Conners' Kiddie Continuous Performance Test Second Edition (K-CPT 2): CPT-Hit Reaction Time Block Change. CPT HRT BC indicates the change in mean response speed as the administration of the test progresses in blocks. A decrease in CPT HRT BC indicates a decrease in reaction time, which means the participant's information processing efficiency increases, and an improvement in sustained attention is noted. The off-treatment period of 3 months was implemented to study whether the impact of treatment persists or goes back to baseline. The number of patients that displayed an increase in CPT HRT BC score (towards baseline) after 3 months off treatment as compared to 6 months on treatment is noted here. | Change after 3 months off treatment |
| Neuropsychological Score of Working Memory Index Scale (WMI) | Subjects were administered the Working Memory Index Scale (WMI) from either the Wechsler Primary and Preschool Scale of Intelligence, 4th Edition (WPPSI-IV), Wechsler Intelligence Scale for Children, 5th Edition (WISC-V), or the Wechsler Adult Intelligence Scale, 4th Edition (WAIS-IV) according to the age of subject. An increase WMI score would indicate an improvement in the cognitive ability of identifying, reorganizing and retaining information for a brief period of time. The number of participants that showed an increase in the WMI score after 6 months of treatment is noted here. | Change post 6 months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| EEG Changes: Generalized Spike Wave Activity and Burst | The number of generalized spike wave (GSW) activity and bursts were extracted from the patient EEGs. GSW and bursts per hour was calculated. A decrease in the spike wave and burst indicated an improvement. The number of patients that displayed a decrease in GSW and burst per hour after 6 months of treatment in noted here. | Change post 6 months of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan Pascual, MD | Study Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26341673 | Background | Pascual JM, Ronen GM. Glucose Transporter Type I Deficiency (G1D) at 25 (1990-2015): Presumptions, Facts, and the Lives of Persons With This Rare Disease. Pediatr Neurol. 2015 Nov;53(5):379-93. doi: 10.1016/j.pediatrneurol.2015.08.001. Epub 2015 Aug 10. | |
| 28437535 | Background | Hao J, Kelly DI, Su J, Pascual JM. Clinical Aspects of Glucose Transporter Type 1 Deficiency: Information From a Global Registry. JAMA Neurol. 2017 Jun 1;74(6):727-732. doi: 10.1001/jamaneurol.2017.0298. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Triheptanoin | This is a single arm study. Patients diagnosed with G1D were enrolled in the study. They received the triheptanoin oil treatment dosed at 45% of the participant's daily caloric intake, divided into 4 doses per day. This intervention was administered for 6 months followed by a 3 month off intervention period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| 6 Months on Treatment |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 22, 2021 |
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All subjects will receive supplementation at the maximum tolerated dose.
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| Neuropsychological Score of Working Memory Index Scale (WMI) | Subjects were administered the Working Memory Index Scale (WMI) from either the Wechsler Primary and Preschool Scale of Intelligence, 4th Edition (WPPSI-IV), Wechsler Intelligence Scale for Children, 5th Edition (WISC-V), or the Wechsler Adult Intelligence Scale, 4th Edition (WAIS-IV) according to the age of subject. An increase WMI score would indicate an improvement in the cognitive ability of identifying, reorganizing and retaining information for a brief period of time. The 3 months off-treatment period was designed to study whether the impact of treatment persists or goes back to baseline. The number of participants that showed a decrease in the WMI score after 3 months off treatment as compared to 6 months on treatment was calculated. | Change after 3 months off-treatment |
| Neuropsychological Score of Processing Speed Index (PSI) | Subjects were administered the Processing Speed Index Scale (PSI) from either the Wechsler Primary and Preschool Scale of Intelligence, 4th Edition (WPPSI-IV), Wechsler Intelligence Scale for Children, 5th Edition (WISC-V) or the Wechsler Adult Intelligence Scale, 4th Edition (WAIS-IV) according to the age of subject. An increase PSI score would indicate an improvement in the motor-based estimate of the subject's cognitive processing speed. The number of participants that showed an increase in the PSI score after 6 months of treatment as compared to baseline is noted here. | Change post 6 months of treatment |
| Neuropsychological Score of Processing Speed Index (PSI) | Subjects were administered the Processing Speed Index Scale (PSI) from either the Wechsler Primary and Preschool Scale of Intelligence, 4th Edition (WPPSI-IV), Wechsler Intelligence Scale for Children, 5th Edition (WISC-V) or the Wechsler Adult Intelligence Scale, 4th Edition (WAIS-IV) according to the age of subject. An increase PSI score would indicate an improvement in the motor-based estimate of the subject's cognitive processing speed. The 3 months off-treatment period was designed to study whether the impact of treatment persists or goes back to baseline. The number of participants that showed a decrease in the WMI score after 3 months off treatment as compared to 6 months on treatment was calculated. | Change after 3 months off-treatment |
| EEG Changes: Generalized Spike Wave Activity and Burst | The number of generalized spike wave (GSW) activity and bursts were extracted from the patient EEGs. GSW and bursts per hour was calculated. A decrease in the spike wave and burst indicated an improvement. The off-treatment period of 3 months was implemented to study whether the impact of treatment persists or goes back to baseline. The number of patients that displayed an increase in GSW and burst per hour (towards baseline) after 3 months off treatment as compared to 6 months on treatment is noted here. | Change after 3 months off-treatment |
| Brief Ataxia Rating Scale | Ataxia is scored as per the Brief ataxia rating scale (BARS) - a modified form of the International Cooperative Ataxia Rating Scale (ICARS). The possible range for the scores is from 0 (normal, no ataxia) to 30 (severe ataxia). A decrease in the BARS score indicates an improvement in the ataxia symptoms. The number of participants that showed a decrease in BARS score after 6 months of intervention is reported here. | Change post 6 months of treatment |
| Brief Ataxia Rating Scale | Ataxia is scored as per the Brief ataxia rating scale (BARS) - a modified form of the International Cooperative Ataxia Rating Scale (ICARS). The possible range for the scores is from 0 (normal, no ataxia) to 30 (severe ataxia). A decrease in the BARS score indicates an improvement in the ataxia symptoms. The off-treatment period of 3 months was implemented to study whether the impact of treatment persists or goes back to baseline. The number of participants that showed a subsequent increase in BARS score (towards baseline) after the of 3 months of no treatment as compared to 6 months on treatment are recorded here. | Change after 3 months off treatment |
| Clinical Global Impression Severity Scale | The Clinical global impression - Severity (CGI-S) scale is used to evaluate the illness severity where the scores range from 1 (very much improved) through to 7 (very much worse). A decrease in the CGI-S score indicates a decrease in illness severity. The number of participants that showed a decrease in CGI-S score after 6 months of intervention as compared to baseline is reported here. | Change post 6 months of treatment |
| Clinical Global Impression Severity Scale | The Clinical global impression - Severity (CGI-S) scale is used to evaluate the illness severity where the scores range from 1 (very much improved) through to 7 (very much worse). A decrease in the CGI-S score indicates a decrease in illness severity. The off-treatment period of 3 months was designed to study whether the impact of treatment persists or goes back to baseline. The number of participants that showed an increase in CGI-S score (towards baseline) after 3 months off treatment as compared to 6 months on treatment is reported | Change after 3 months off-treatment |
| 25110966 | Background | Pascual JM, Liu P, Mao D, Kelly DI, Hernandez A, Sheng M, Good LB, Ma Q, Marin-Valencia I, Zhang X, Park JY, Hynan LS, Stavinoha P, Roe CR, Lu H. Triheptanoin for glucose transporter type I deficiency (G1D): modulation of human ictogenesis, cerebral metabolic rate, and cognitive indices by a food supplement. JAMA Neurol. 2014 Oct;71(10):1255-65. doi: 10.1001/jamaneurol.2014.1584. |
| COMPLETED |
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| NOT COMPLETED |
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| 3 Months Off-treatment |
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| ID | Title | Description |
|---|---|---|
| BG000 | Triheptanoin | This is a single arm study. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Neuropsychological Score of Sustained Attention | Sustained attention was evaluated using a subtest of Conners' Kiddie Continuous Performance Test Second Edition (K-CPT 2): CPT-Hit Reaction Time Block Change. CPT HRT BC indicates the change in mean response speed as the administration of the test progresses in blocks. A decrease in CPT HRT BC indicates a decrease in reaction time, which means the participant's information processing efficiency increases, and an improvement in sustained attention is noted. The number of participants that showed a decrease in the CPT HRT BC score after 6 months of treatment as compared to baseline is noted here. | Although 29 patients completed the 6-month treatment phase, some patients were unable to perform the test due to cognitive or physical impairment. The analysis population comprises of participants who were present at the time of testing and were able to comprehend and perform the test. | Posted | Count of Participants | Participants | Change post 6 months of treatment |
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| Primary | Neuropsychological Score of Sustained Attention | Sustained attention was evaluated using a subtest of Conners' Kiddie Continuous Performance Test Second Edition (K-CPT 2): CPT-Hit Reaction Time Block Change. CPT HRT BC indicates the change in mean response speed as the administration of the test progresses in blocks. A decrease in CPT HRT BC indicates a decrease in reaction time, which means the participant's information processing efficiency increases, and an improvement in sustained attention is noted. The off-treatment period of 3 months was implemented to study whether the impact of treatment persists or goes back to baseline. The number of patients that displayed an increase in CPT HRT BC score (towards baseline) after 3 months off treatment as compared to 6 months on treatment is noted here. | Although 28 patients completed the 3-month treatment phase, some patients were unable to perform the test due to cognitive or physical impairment. The analysis population comprises of participants who were present at the time of testing and were able to comprehend and perform the test. | Posted | Count of Participants | Participants | Change after 3 months off treatment |
| ||||||||||||||||||||||||||||
| Primary | Neuropsychological Score of Working Memory Index Scale (WMI) | Subjects were administered the Working Memory Index Scale (WMI) from either the Wechsler Primary and Preschool Scale of Intelligence, 4th Edition (WPPSI-IV), Wechsler Intelligence Scale for Children, 5th Edition (WISC-V), or the Wechsler Adult Intelligence Scale, 4th Edition (WAIS-IV) according to the age of subject. An increase WMI score would indicate an improvement in the cognitive ability of identifying, reorganizing and retaining information for a brief period of time. The number of participants that showed an increase in the WMI score after 6 months of treatment is noted here. | Some patients were unable to perform the test due to cognitive, physical impairment or underdeveloped vocabulary skills. The analysis population comprises of participants who were present at the time of testing and were able to comprehend and perform the test. | Posted | Count of Participants | Participants | Change post 6 months of treatment |
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| Primary | Neuropsychological Score of Working Memory Index Scale (WMI) | Subjects were administered the Working Memory Index Scale (WMI) from either the Wechsler Primary and Preschool Scale of Intelligence, 4th Edition (WPPSI-IV), Wechsler Intelligence Scale for Children, 5th Edition (WISC-V), or the Wechsler Adult Intelligence Scale, 4th Edition (WAIS-IV) according to the age of subject. An increase WMI score would indicate an improvement in the cognitive ability of identifying, reorganizing and retaining information for a brief period of time. The 3 months off-treatment period was designed to study whether the impact of treatment persists or goes back to baseline. The number of participants that showed a decrease in the WMI score after 3 months off treatment as compared to 6 months on treatment was calculated. | Some patients were unable to perform the test due to cognitive, physical impairment or underdeveloped vocabulary skills. The analysis population comprises of participants who were present at the time of testing and were able to comprehend and perform the test. | Posted | Count of Participants | Participants | Change after 3 months off-treatment |
| ||||||||||||||||||||||||||||
| Primary | Neuropsychological Score of Processing Speed Index (PSI) | Subjects were administered the Processing Speed Index Scale (PSI) from either the Wechsler Primary and Preschool Scale of Intelligence, 4th Edition (WPPSI-IV), Wechsler Intelligence Scale for Children, 5th Edition (WISC-V) or the Wechsler Adult Intelligence Scale, 4th Edition (WAIS-IV) according to the age of subject. An increase PSI score would indicate an improvement in the motor-based estimate of the subject's cognitive processing speed. The number of participants that showed an increase in the PSI score after 6 months of treatment as compared to baseline is noted here. | Some patients were cognitively unable to perform or comprehend the test. The analysis population comprises of participants who were present at the time of testing and were able to comprehend and perform the test. | Posted | Count of Participants | Participants | Change post 6 months of treatment |
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| Primary | Neuropsychological Score of Processing Speed Index (PSI) | Subjects were administered the Processing Speed Index Scale (PSI) from either the Wechsler Primary and Preschool Scale of Intelligence, 4th Edition (WPPSI-IV), Wechsler Intelligence Scale for Children, 5th Edition (WISC-V) or the Wechsler Adult Intelligence Scale, 4th Edition (WAIS-IV) according to the age of subject. An increase PSI score would indicate an improvement in the motor-based estimate of the subject's cognitive processing speed. The 3 months off-treatment period was designed to study whether the impact of treatment persists or goes back to baseline. The number of participants that showed a decrease in the WMI score after 3 months off treatment as compared to 6 months on treatment was calculated. | Some patients were cognitively unable to perform or comprehend the test. The analysis population comprises of participants who were present at the time of testing and were able to comprehend and perform the test. | Posted | Count of Participants | Participants | Change after 3 months off-treatment |
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| Secondary | EEG Changes: Generalized Spike Wave Activity and Burst | The number of generalized spike wave (GSW) activity and bursts were extracted from the patient EEGs. GSW and bursts per hour was calculated. A decrease in the spike wave and burst indicated an improvement. The number of patients that displayed a decrease in GSW and burst per hour after 6 months of treatment in noted here. | Out of 45 enrolled, 29 patients completed the 6 month treatment period | Posted | Count of Participants | Participants | Change post 6 months of treatment |
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| Secondary | EEG Changes: Generalized Spike Wave Activity and Burst | The number of generalized spike wave (GSW) activity and bursts were extracted from the patient EEGs. GSW and bursts per hour was calculated. A decrease in the spike wave and burst indicated an improvement. The off-treatment period of 3 months was implemented to study whether the impact of treatment persists or goes back to baseline. The number of patients that displayed an increase in GSW and burst per hour (towards baseline) after 3 months off treatment as compared to 6 months on treatment is noted here. | Out of 29 patients who completed the treatment period, 28 returned for the 3 month off-treatment visit. | Posted | Count of Participants | Participants | Change after 3 months off-treatment |
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| Secondary | Brief Ataxia Rating Scale | Ataxia is scored as per the Brief ataxia rating scale (BARS) - a modified form of the International Cooperative Ataxia Rating Scale (ICARS). The possible range for the scores is from 0 (normal, no ataxia) to 30 (severe ataxia). A decrease in the BARS score indicates an improvement in the ataxia symptoms. The number of participants that showed a decrease in BARS score after 6 months of intervention is reported here. | Although 29 patients completed the study, some patients were unable to perform the test due to physical impairment and inability to comprehend the task. Here, the number of participants analyzed reflects the total number of patients that were present at the test and were able to complete it. | Posted | Count of Participants | Participants | Change post 6 months of treatment |
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| Secondary | Brief Ataxia Rating Scale | Ataxia is scored as per the Brief ataxia rating scale (BARS) - a modified form of the International Cooperative Ataxia Rating Scale (ICARS). The possible range for the scores is from 0 (normal, no ataxia) to 30 (severe ataxia). A decrease in the BARS score indicates an improvement in the ataxia symptoms. The off-treatment period of 3 months was implemented to study whether the impact of treatment persists or goes back to baseline. The number of participants that showed a subsequent increase in BARS score (towards baseline) after the of 3 months of no treatment as compared to 6 months on treatment are recorded here. | Although 28 patients completed the off-treatment phase of study, some patients were unable to perform the test due to physical impairment and inability to comprehend the task. Here, the number of participants analyzed reflects the total number of patients that were present at the test and were able to comprehend it. | Posted | Count of Participants | Participants | Change after 3 months off treatment |
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| Secondary | Clinical Global Impression Severity Scale | The Clinical global impression - Severity (CGI-S) scale is used to evaluate the illness severity where the scores range from 1 (very much improved) through to 7 (very much worse). A decrease in the CGI-S score indicates a decrease in illness severity. The number of participants that showed a decrease in CGI-S score after 6 months of intervention as compared to baseline is reported here. | Out of the 45 patients enrolled, 29 completed the 6 month treatment phase. | Posted | Count of Participants | Participants | Change post 6 months of treatment |
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| Secondary | Clinical Global Impression Severity Scale | The Clinical global impression - Severity (CGI-S) scale is used to evaluate the illness severity where the scores range from 1 (very much improved) through to 7 (very much worse). A decrease in the CGI-S score indicates a decrease in illness severity. The off-treatment period of 3 months was designed to study whether the impact of treatment persists or goes back to baseline. The number of participants that showed an increase in CGI-S score (towards baseline) after 3 months off treatment as compared to 6 months on treatment is reported | Out of the 29 patients that completed the treatment phase, 28 completed the following 3 month off-treatment phase. The assessment was incomplete for one patient due to inability to report symptoms. | Posted | Count of Participants | Participants | Change after 3 months off-treatment |
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9 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Triheptanoin | This is a single arm study. Patients diagnosed with G1D were enrolled in the study. They received the triheptanoin oil treatment dosed at 45% of the participant's daily caloric intake, divided into 4 doses per day. This intervention was administered for 6 months followed by a 3 month off intervention period. | 0 | 45 | 0 | 45 | 41 | 45 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild nausea | Gastrointestinal disorders | Systematic Assessment |
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| Mild vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Upset stomach | Gastrointestinal disorders | Systematic Assessment |
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| Stomach pain or cramping | General disorders | Systematic Assessment |
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| Acid reflux | Gastrointestinal disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Seizure | Nervous system disorders | Systematic Assessment |
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| Hypoglycemia | General disorders | Systematic Assessment |
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| Loss of appetite | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Juan Pascual | Weill Cornell Medicine | (212) 746-3278 | jup9003@med.cornell.edu |
| Feb 21, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 22, 2021 | Feb 21, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D044882 | Glucose Metabolism Disorders |
| C562806 | Glycogen Storage Disease Id |
| C536830 | Glut1 Deficiency Syndrome |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C531010 | triheptanoin |
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| Unknown or Not Reported |
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