File size: 4,000 Bytes
c0447d4
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65
66
67
68
69
70
71
72
73
74
75
76
77
78
79
80
81
82
83
84
85
86
87
88
89
90
91
92
93
94
95
96
97
98
99
100
101
102
103
104
105
106
107
108
109
110
111
112
113
114
115
116
117
118
119
120
121
122
123
124
125
126
127
128
129
130
131
132
133
134
135
136
{
  "version": "1.1.0",
  "fields": [
    {
      "name": "nct_id",
      "type": "str",
      "description": "ClinicalTrials.gov unique identifier (NCT######)"
    },
    {
      "name": "title",
      "type": "str",
      "description": "Brief title of the clinical study"
    },
    {
      "name": "official_title",
      "type": "str | None",
      "description": "Full official title of the study"
    },
    {
      "name": "status",
      "type": "str",
      "description": "Overall recruitment status (e.g. COMPLETED, RECRUITING)"
    },
    {
      "name": "start_date",
      "type": "str | None",
      "description": "Study start date (YYYY-MM-DD)"
    },
    {
      "name": "completion_date",
      "type": "str | None",
      "description": "Primary completion date (YYYY-MM-DD)"
    },
    {
      "name": "sponsor_name",
      "type": "str",
      "description": "Lead sponsor organization name"
    },
    {
      "name": "sponsor_class",
      "type": "str | None",
      "description": "Sponsor classification (INDUSTRY, NIH, OTHER_GOV, etc.)"
    },
    {
      "name": "conditions",
      "type": "list[str]",
      "description": "Medical conditions or diseases studied"
    },
    {
      "name": "study_type",
      "type": "str | None",
      "description": "Study type: INTERVENTIONAL or OBSERVATIONAL"
    },
    {
      "name": "phases",
      "type": "list[str]",
      "description": "Clinical trial phases (e.g. PHASE3)"
    },
    {
      "name": "enrollment",
      "type": "int | None",
      "description": "Target or actual enrollment count"
    },
    {
      "name": "allocation",
      "type": "str | None",
      "description": "Allocation method: RANDOMIZED or NON_RANDOMIZED"
    },
    {
      "name": "masking",
      "type": "str | None",
      "description": "Blinding type (e.g. DOUBLE, OPEN_LABEL)"
    },
    {
      "name": "interventions",
      "type": "list[dict]",
      "description": "Interventions with type, name, and description"
    },
    {
      "name": "primary_outcomes",
      "type": "list[dict]",
      "description": "Primary outcome measures with measure and time_frame"
    },
    {
      "name": "secondary_outcomes",
      "type": "list[dict]",
      "description": "Secondary outcome measures with measure and time_frame"
    },
    {
      "name": "minimum_age",
      "type": "str | dict | None",
      "description": "Minimum participant age (parsed value and unit)"
    },
    {
      "name": "maximum_age",
      "type": "str | dict | None",
      "description": "Maximum participant age (parsed value and unit)"
    },
    {
      "name": "sex",
      "type": "str | None",
      "description": "Eligible sex: ALL, FEMALE, or MALE"
    },
    {
      "name": "results_available",
      "type": "bool",
      "description": "Whether results have been posted to ClinicalTrials.gov"
    },
    {
      "name": "locations_count",
      "type": "int | None",
      "description": "Number of study sites / locations"
    },
    {
      "name": "countries",
      "type": "list[str]",
      "description": "Countries where the study is conducted"
    },
    {
      "name": "trial_duration_days",
      "type": "int | None",
      "description": "Days from start_date to completion_date. Null if either date missing."
    },
    {
      "name": "therapeutic_area",
      "type": "str",
      "description": "Disease area classification: Oncology, Cardiovascular, Neurology / CNS, Infectious Disease, Metabolic / Endocrine, Immunology / Rheumatology, Respiratory, Gastroenterology, Dermatology, Ophthalmology, Rare Disease / Orphan, Other."
    },
    {
      "name": "primary_endpoint_met",
      "type": "str",
      "description": "Whether the primary endpoint was achieved: 'true', 'false', or 'unknown'. Coverage: ~45% of records (those with posted results on ClinicalTrials.gov). Extracted by LLM from the results section."
    }
  ],
  "schema_hash": "5db9cfdee697b897f9a28d792fa1813a00d321ca97d7fea6e4c0507b237ef923"
}