CDE Detailed Report

Disease: system
Subdomain Name: Other Clinical Data
CRF: files

Displaying 1 - 50 of 175
CDE ID CDE Name Variable Name Definition Short Description Question Text Permissible Values Description Data Type Disease Specific Instructions Disease Specific Reference Population Classification (e.g., Core) Version Number Version Date CRF Name (CRF Module / Guidance) Subdomain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C08171 Diffuse plaques density category DiffusePlaqDenstyCat Density of diffuse plaques (plaques with non-compact amyloid and no apparent dystrophic neurites) Density of diffuse plaques (plaques with non-compact amyloid and no apparent dystrophic neurites) Immatue and diffuse type plaques (are plaques without the dense core of the neuritic plaques and are either with [immature] or without [diffuse] dystrophic neurites) No plaques;Sparse plaques;Moderate plaques;Frequent plaques;Not assessed;Unknown No plaques;Sparse plaques;Moderate plaques;Frequent plaques;Not assessed;Unknown Alphanumeric

Amyloid plaques

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Single Pre-Defined Value Selected

C18153 Data unknown text DataUnknwnTxt The free-text field to Mark an "X" in to record if data are unknown or not available The free-text field to Mark an "X" in to record if data are unknown or not availabl CAG repeat HD-IT 15 CAG repeat expansion unknown Alphanumeric

If the size of the HD-IT 15 CAG expansion is unknown, record as Not Known in the next data element.

Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Neuropathology Data Form Other Clinical Data Assessments and Examinations 20

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C15085 Silver staining methods type SilverStainMethdsTyp Silver staining methods used for identifying Alzheimer disease type changes Silver staining methods used for identifying Alzheimer disease type changes Silver methods Bielschowsky;Other, specify;Not assessed;Missing/Unknown Bielschowsky;Other, specify;Not assessed;Missing/Unknown Alphanumeric

Answer for each type of microscopic brain abnormality

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C15021 Brain atrophy substantia nigra appearance grade BrAtSubstantiaNigraAppGrade Grade of pigmentation of the substantia nigra Grade of pigmentation of the substantia nigra Substantia nigra Well pigmented;Darker 1+;Darker 2+;Darker 3+;Very severe 4+ (Darker);Paler 1+;Paler 2+;Paler 3+;Very severe 4+ (Paler) Well pigmented;Darker 1+;Darker 2+;Darker 3+;Very severe 4+ (Darker);Paler 1+;Paler 2+;Paler 3+;Very severe 4+ (Paler) Alphanumeric

Striatum atrophy

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C17755 Striatum atrophy claustrum atrophy status StrAtrophyClaustrumAtrophyStat Status of atrophy in the claustrum Status of atrophy in the claustru Claustrum atrophy Absent;Present Absent;Present Alphanumeric

Striatum atrophy

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C15053 Brain atrophy substantia nigra pars compacta neuronal loss indicator BrAtSubNigraParsCompNeurLosInd Indicator of neuronal loss in the pars compacta of the substantia nigra Indicator of neuronal loss in the pars compacta of the substantia nigr Pars compacta Neuronal loss No neuronal loss;Yes neuronal loss No neuronal loss;Yes neuronal loss Alphanumeric

Substantia nigra

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C15064 Brain atrophy nucleus coeruleus globosum neuronal tangles (GNT) severity result BrAtNucCoerGloNeurTanSevReslt Quantitative result of the severity of GNT in the nucleus coeruleus Quantitative result of the severity of GNT in the nucleus coeruleu Present Mild 1+;Moderate 2+;Severe 3+;Very severe 4+ Mild 1+;Moderate 2+;Severe 3+;Very severe 4+ Alphanumeric

Nucleus coeruleus

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C14972 Macroscopical examination fixed brain source MacroExamFixedBrainSource The part(s) of the fixed brain used for macroscopical examination The part(s) of the fixed brain used for macroscopical examination Macroscopical examination Fixed Whole brain;Left half brain;Right half brain;Not available;Other, specify Whole brain;Left half brain;Right half brain;Not available;Other, specify Alphanumeric

Indicate the parts selected for evaluation

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C15096 Hemorrhages single or multiple vascular territories name HemSingMultiVascTerrName Name of the vascular territories where hemorrhages occur Name of the vascular territories where hemorrhages occur Vascular territories (ACA anterior cerebral artery; MCA middle cerebral artery; PCA posterior cerebral artery) ACA;MCA;PCA;Combined ACA=anterior cerebral artery;MCA=middle cerebral artery;PCA=posterior cerebral artery; Alphanumeric

No additional instructions

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C15032 Brain atrophy hippocampal formation neuronal loss severity result BrAtHippocFormNeurLossSevReslt Quantitative result of the severity of neuronal loss in the hippocampal formation Quantitative result of the severity of neuronal loss in the hippocampal formation Yes, neuronal loss 1+/4+;2+/4+;3+/4+;4+/4+ 1+/4+=Mild;2+/4+=Moderate;3+/4+=Severe;4+/4+=Very severe Alphanumeric

This question is answered if 'Yes, neuronal loss' is answered for 'Hippocampal formation neuronal loss'

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C04802 Death date and time DeathDateTime Date (and time, if known) of participant's/subject's death Date (and time, if known) of participant's/subject's death Date of Death; Time of Death Date or Date & Time

Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).

ISO 8601 - http://www.iso.org/iso/iso_catalogue.htm Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Neuropathology Data Form Other Clinical Data Assessments and Examinations

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2004152
C08157 Photograph macroscopic indicator PhotographsMacroscopicInd Indicator of whether macroscopic photographs were taken Indicator of whether macroscopic photographs were taken Are macroscopic photographs available? Yes;No Yes;No Alphanumeric

If YES is answered explain what macroscopic photographs were taken

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C15075 Brain atrophy cerebellum cortical neuronal loss in receptive layer indicator BrAtCerebCortNeurLossRecLayInd Indicator of cortical neuronal loss in the receptive layer (granular) of the cerebellum Indicator of cortical neuronal loss in the receptive layer (granular) of the cerebellum Receptive layer (granular) No, neuronal loss;Yes, neuronal loss No, neuronal loss;Yes, neuronal loss Alphanumeric

Cerebellum; Cortical neuronal loss

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C14983 Brain atrophy coronal sections amygdala status BrAtCorSecAmygdalaStat Status of amygdala atrophy of the coronal sections upon gross examination Status of amygdala atrophy of the coronal sections upon gross examinatio Amygdala atrophy Absent;Present Absent;Present Alphanumeric

Coronal slices: On gross examination of the coronal sections

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C15107 Huntingtons Disease diagnosis grade HDDiagnosGrade The grade of severity of HD or amyloid angiopathy severity The grade of severity of HD or amyloid angiopathy severity Final Clinicopathological Diagnosis Grade 1;Grade 2;Grade 3;Grade 4 Grade 1;Grade 2;Grade 3;Grade 4 Alphanumeric

Only answered if "Huntington disease" or "Cerebral amyloid angiopathy" are answered for Final Clinicopathological diagnoses

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C15043 Brain atrophy thalamus neuronal loss indicator BrAtThalamusNeurLossInd Indicator of neuronal loss in the thalamus Indicator of neuronal loss in the thalamu Thalamus Neuronal loss No neuronal loss;Yes neuronal loss No neuronal loss;Yes neuronal loss Alphanumeric

No additional instructions

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C08173 Ischemic hemorrhagic or vascular pathology indicator IschHemVasclPathInd Indicator of the presence of ischemic, hemorrhagic, or vascular pathology Indicator of the presence of ischemic, hemorrhagic, or vascular pathology Are there ischemic or hemorrhagic changes? Yes;No;Unknown;Not assessed Yes;No;Unknown;Not assessed Alphanumeric

If 'No' is answered for ischemic or hemorrhagic changes, skip to question 43.

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C18667 Data source other text DataSourcOTH The free-text field related to 'Data source' specifying other text. Source of the data provided on the case report form The free-text field related to 'Data source' specifying other text. Source of the data provided on the case report form Other, specify Alphanumeric

No additional instructions

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C15086 Ischemic or hemorrhagic changes event category IschHemChangesEventCat Category of the ischemic or hemorrhagic changes Category of the ischemic or hemorrhagic changes Yes, present Single;Multiple Single;Multiple Alphanumeric

No additional instructions

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Single Pre-Defined Value Selected

C15022 Brain atrophy nucleus coeruleus appearance grade BrAtNucleusCoeruleusAppGrade Grade of pigmentation of the nucleus coeruleus Grade of pigmentation of the nucleus coeruleus Nucleus coeruleus Well pigmented;Darker 1+;Darker 2+;Darker 3+;Very severe 4+ (Darker);Paler 1+;Paler 2+;Paler 3+;Very severe 4+ (Paler) Well pigmented;Darker 1+;Darker 2+;Darker 3+;Very severe 4+ (Darker);Paler 1+;Paler 2+;Paler 3+;Very severe 4+ (Paler) Alphanumeric

Striatum atrophy

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C17756 Striatum atrophy claustrum atrophy severity result StrAtrophyClauAtrophySevReslt Quantitative result of the severity of atrophy located in the claustrum Quantitative result of the severity of atrophy located in the claustr Present Mild 1+;Moderate 2+;Severe 3+;Very severe 4+ Mild 1+;Moderate 2+;Severe 3+;Very severe 4+ Alphanumeric

Striatum atrophy

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C15054 Brain atrophy substantia nirgra pars compacta neuronal loss severity result BrAtSubNiParsCoNeuLossSevReslt Quantitative result of the severity of neuronal loss in the pars compacta Quantitative result of the severity of neuronal loss in the pars compact Yes, neuronal loss Mild 1+;Moderate 2+;Severe 3+;Very severe 4+ Mild 1+;Moderate 2+;Severe 3+;Very severe 4+ Alphanumeric

Substantia nigra

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C15065 Brain atrophy pons neuronal loss indicator BrAtPonsNeurLossInd Indicator of neuronal loss in the pons Indicator of neuronal loss in the pon Pons Neuronal loss No neuronal loss;Yes neuronal loss No neuronal loss;Yes neuronal loss Alphanumeric

Pons: Neuronal loss

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Single Pre-Defined Value Selected

C14973 Microscopical examination blocks source MicroExamBlocksSource The source of blockage based on microscopical examination of brain The source of blockage based on microscopical examination of brain Microscopical examination Source of blocks Not available;Other, specify;Bilateral;Left half of brain;Right half of brain Not available;Other, specify;Bilateral;Left half of brain;Right half of brain Alphanumeric

Indicate the parts selected for evaluation

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C15097 Single or multiple hemorrhages description text SingMultiHemDescriptTxt The text description of the hemorrhages The text description of the hemorrhages Describe Alphanumeric

Answer for each vascular territory and event category

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C15033 Brain atrophy amygdala neuronal loss indicator BrAtAmygdalaNeurLossInd Indicator of neuronal loss in the amygdala Indicator of neuronal loss in the amygdal Amygdala Neuronal Loss No neuronal loss;Yes neuronal loss No neuronal loss;Yes neuronal loss Alphanumeric

No additional instructions

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C06005 Data collected date and time DataCollDateTime Date (and time, if applicable and known) the data were collected. This may be the date/time a particular examination or procedure was performed Date (and time, if applicable and known) the data were collected. This may be the date/time a particular examination or procedure was performe Date form completed Date or Date & Time

Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).

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C08158 Brain weight measurement BrainWgtMeasr Weight of the participant's/subject's brain in grams Weight of the participant's/subject's brain in grams Brain weight-Part weighed Numeric Values

This value should be recorded in grams (g) for all brain tissue weighed

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gram
C15076 Brain atrophy cerebellum cortical neuronal loss in receptive layer severity result BrAtCerCortNeuLosRecLaSevReslt Quantitative result of the severity of cortical neuronal loss in the receptive layer of the cerebellum Quantitative result of the severity of cortical neuronal loss in the receptive layer of the cerebellum Yes, neuronal loss Mild 1+;Moderate 2+;Severe 3+;Very severe 4+ Mild 1+;Moderate 2+;Severe 3+;Very severe 4+ Alphanumeric

Cerebellum; Cortical neuronal loss

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C14984 Brain atrophy coronal sections amygdala severity result BrAtCorSecAmygdalaSevReslt Quantitative result of the severity of amygdala atrophy in the coronal sections of the brain Quantitative result of the severity of amygdala atrophy in the coronal sections of the brain Present Mild 1+;Moderate 2+;Severe3+;Very severe 4+ Mild 1+;Moderate 2+;Severe3+;Very severe 4+ Alphanumeric

Coronal slices: On gross examination of the coronal sections

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C15108 Diagnoses final clinicopathological severity scale DiagnosFinClinicopathSevScale Scale of the severity or intensity of the diagnosis Scale of the severity or intensity of the diagnosis Final Clinicopathological Diagnosis Mild;Moderate;Severe Mild;Moderate;Severe Alphanumeric

Only answered if "Encephalopathy of hypoxic-ischemic type, acute", "Alzheimer changes", or "Status cribrosus and lacunaris" are answered for Final Clinicopathological diagnoses

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C15044 Brain atrophy thalamus neuronal loss severity result BrAtThalamusNeurLossSevReslt Quantitative result of the severity of neuronal loss in the thalamus Quantitative result of the severity of neuronal loss in the thalamus Yes, neuronal loss Mild 1+;Moderate 2+;Severe 3+;Very severe 4+ Mild 1+;Moderate 2+;Severe 3+;Very severe 4+ Alphanumeric

This question is answered if "Yes, neuronal loss" is answered for 'Thalamus: neuronal loss"

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C08175 Cortical microinfarct indicator CortclMicroinfarcInd Indicator of the presence of one or more infarcts that are detected microscopically (including "granular atrophy") and may not be grossly visible, or may appear to the naked eye as cortical granularity Indicator of the presence of one or more infarcts that are detected microscopically (including "granular atrophy") and may not be grossly visible, or may appear to the naked eye as cortical granularity Are there single or multiple cortical microinfarcts (each, <1.5cm in greatest dimension, including "granular atrophy")? Yes;No;Unknown;Not assessed Yes;No;Unknown;Not assessed Alphanumeric

Cortical microinfarcts are defined as

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C18669 Diagnosis final clinical death other text DiagnosFinalClinDeathOTH The free-text field related to 'Diagnosis final clinical death type' specifying other text. Physician's final clinical diagnosis for the participant/subject The free-text field related to 'Diagnosis final clinical death type' specifying other text. Physician's final clinical diagnosis for the participant/subject Other, specify Alphanumeric

No additional instructions

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C15087 Ischemic or hemorrhagic vascular territories name IschHemVasclTerritoriesName Name of the vascular territories where ischemic or hemorrhagic changes occur Name of the vascular territories where ischemic or hemorrhagic changes occur Vascular territories (ACA anterior cerebral artery; MCA middle cerebral artery; PCA posterior cerebral artery) ACA;MCA;PCA;Combined ACA=anterior cerebral artery;MCA=middle cerebral artery;PCA=posterior cerebral artery; Alphanumeric

No additional instructions

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Single Pre-Defined Value Selected

C15023 Brain atrophy striatum brainstem status BrAtStriatumBrainstemStat Status of brainstem atrophy in the striatum Status of brainstem atrophy in the striatu Brainstem atrophy Absent;Present Absent;Present Alphanumeric

Striatum atrophy

Kemper TL. Neuroanatomical and Neuropathological changes during aging and dementia, Second edn., Oxford University Press, New York, 1994, 3-67. Esiri MM and Morris JH. Practical approach to pathological diagnosis. In: Esiri MM, Lee VM-Y, Trojanowski JQ, eds. The neuropathology of dementia. First ed. Cambridge CB2 2RU, UK: Cambridge University Press; 2004:48-74. Adult Supplemental 3.00 2013-07-14 19:48:50.273 Neuropathology Data Form Other Clinical Data Assessments and Examinations

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C17757 Striatum atrophy hypothalamus atrophy status StrAtrophyHypothAtrophyStat Status of atrophy in the hypothalamus Status of atrophy in the hypothalamu Hypothalamus atrophy Absent;Present Absent;Present Alphanumeric

Striatum atrophy

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C15055 Brain atrophy substantia nigra pars reticulata neuronal loss indicator BrAtSubNiParsReticNeurLosInd Indicator of neuronal loss in the pars reticulata of the substantia nigra Indicator of neuronal loss in the pars reticulata of the substantia nigr Pars reticulata Neuronal loss No neuronal loss;Yes neuronal loss No neuronal loss;Yes neuronal loss Alphanumeric

Substantia nigra

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C15066 Brain atrophy pons neuronal loss severity result BrAtPonsNeurLossSevReslt Quantitative result of the severity of neuronal loss in the pons Quantitative result of the severity of neuronal loss in the pons Yes, neuronal loss Mild 1+;Moderate 2+;Severe 3+;Very severe 4+ Mild 1+;Moderate 2+;Severe 3+;Very severe 4+ Alphanumeric

Pons: Neuronal loss

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Single Pre-Defined Value Selected

C14974 Brain atrophy surface status BrainAtrophySurfStat Status of cerebral atrophy on external surface of the brain upon gross examination Status of cerebral atrophy on external surface of the brain upon gross examination On gross examination of the external surface of the brain, cerebral atrophy Absent;Present Absent;Present Alphanumeric

No additional instructions

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Single Pre-Defined Value Selected

C15098 Cortical laminar necrosis single or multiple event category CortLaminNecSingMultiEvntCat Category of the cortical laminar necrosis Category of the cortical laminar necrosis Yes Single;Multiple Single;Multiple Alphanumeric

No additional instructions

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Single Pre-Defined Value Selected

C15034 Brain atrophy amygdala neuronal loss severity result BrAtAmygdalaNeurLossSevReslt Quantitative result of the severity of neuronal loss in the amygdala Quantitative result of the severity of neuronal loss in the amygdal Yes, neuronal loss 1+/4+;2+/4+;3+/4+;4+/4+ 1+/4+=Mild;2+/4+=Moderate;3+/4+=Severe;4+/4+=Very severe Alphanumeric

This question is answered if 'Yes, neuronal loss' is answered for 'Amygdala neuronal loss'

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Single Pre-Defined Value Selected

C08147 Data source DataSource Source of the data provided on the case report form Source of the data provided on the case report form DATA SOURCE Participant/subject;Mother;Father;Sister;Brother;Son;Daughter;Family, specify relation;Friend;Physician;Chart/Medical record;Other, specify;Unknown;Spouse Participant/subject;Mother;Father;Sister;Brother;Son;Daughter;Family, specify relation;Friend;Physician;Chart/Medical record;Other, specify;Unknown;Spouse Alphanumeric

No additional instructions

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Multiple Pre-Defined Values Selected

C08160 Brain tissue weigh type BrainTissWeighedTyp Type of brain tissue weighed Type of brain tissue weighed Brain weight-Part weighed Fresh whole brain;Fixed whole brain;Fixed not available;Other;Fixed left half;Fixed right half;Fresh left half;Fresh not available;Fresh right half Fresh whole brain;Fixed whole brain;Fixed not available;Other;Fixed left half;Fixed right half;Fresh left half;Fresh not available;Fresh right half Alphanumeric

No additional instructions

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Single Pre-Defined Value Selected

C15077 Brain atrophy cerebellum cortical neuronal loss in effective layer indicator BrAtCerebCortNeurLossEffLayInd Indicator of cortical neuronal loss in the effective layer (Purkinje cells) of the cerebellum Indicator of cortical neuronal loss in the effective layer (Purkinje cells) of the cerebellum Effective layer (Purknje cells) No, neuronal loss;Yes, neuronal loss No, neuronal loss;Yes, neuronal loss Alphanumeric

Cerebellum; Cortical neuronal loss

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Single Pre-Defined Value Selected

C14985 Brain atrophy striatum status BrAtStriatumStat Status of striatum (caudate nucleus [CN], putamen, globus pallidus, and nucleus accumbens) atrophy Status of striatum (caudate nucleus [CN], putamen, globus pallidus, and nucleus accumbens) atrophy Striatum (caudate nucleus [CN], putamen, globus pallidus, and nucleus accumbens) atrophy Absent;Present Absent;Present Alphanumeric

Striatum (caudate nucleus [CN], putamen, globus pallidus, and nucleus accumbens) atrophy

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Single Pre-Defined Value Selected

C15109 Abnormality no diagnosis type AbnrmlyNoDiagTyp The diagnosis if there is no abnormality recognized The diagnosis if there is no abnormality recognized There is no diagnostic abnormality recognized Control brain;Huntington disease, grade 0 Control brain=If without neurological and psychiatric troubles, and without HD-IT15 CAG repeat expansion;Huntington disease, grade 0=If without neurological and psychiatric troubles, but with HD-IT15 CAG repeat expansion Alphanumeric

This question is answered only if "There is no diagnostic abnormality recognized" is answered for Final clinicopathological diagnosis.

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Single Pre-Defined Value Selected

C15045 Brain atrophy thalamus neuronal loss nuclei name BrAtThalamusNeurLossNucName Name of the nuclei in the thalamus involved in the neuronal loss Name of the nuclei in the thalamus involved in the neuronal loss If Yes, specify nuclei that are mainly involved Motor nuclei ventral anterior;Motor nuclei ventral lateral;Centrum medianum;Limbic nuclei anterior;Limbic nuclei dorso-median;Other, specify Motor nuclei ventral anterior;Motor nuclei ventral lateral;Centrum medianum;Limbic nuclei anterior;Limbic nuclei dorso-median;Other, specify Alphanumeric

No additional instructions

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Multiple Pre-Defined Values Selected

C08176 Lacunes single or multiple indicator LacunesSingMultiInd Indicator of the presence of one or more cystic/old infarcts or hemorrhages 1-cm or less in diameter that are usually grossly identified and in the distribution of small parenchymal vessels, most often in basal ganglia, thalamus, pons, cerebellum and cerebral white matter Indicator of the presence of one or more cystic/old infarcts or hemorrhages 1-cm or less in diameter that are usually grossly identified and in the distribution of small parenchymal vessels, most often in basal ganglia, thalamus, pons, cerebellum and cerebral white matte Are there single or multiple lacunes (each > 1,5cm, but = 2c, small artery infarcts Yes;No;Unknown;Not assessed Yes;No;Unknown;Not assessed Alphanumeric

Lacunes are defined as > 1.5cm each but = 2 cm small artery infarcts.

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Single Pre-Defined Value Selected

C18741 Other pathology ischemic vascular disease specify text OthrPathlgyIschmcVasclrDisST The free-text field related to 'Other pathology ischemic vascular disease indicator'. Indicator of the presence of another ischemic or vascular disease not specifically mentioned previously The free-text field related to 'Other pathology ischemic vascular disease indicator'. Indicator of the presence of another ischemic or vascular disease not specifically mentioned previously Other, specify Alphanumeric

If yes, specify other

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CSV