id stringlengths 1 3 | type stringclasses 2
values | text stringlengths 231 7.37k | entities listlengths 1 41 | relations listlengths 0 30 |
|---|---|---|---|---|
1 | silver | Outcome definitions
The primary outcome was the clinical recovery rate at 7 days from the beginning of treatment. Clinical recovery was defined as continuous (>72 hours) recovery of body temperature, respiratory rate, oxygen saturation and cough relief after treatment, with following quantitative criteria: axillary te... | [
{
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"type": "PrimaryOutcome",
"offsets": [
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49,
71
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],
"text": "clinical recovery rate"
},
{
"id": "T2",
"type": "TimeFrame",
"offsets": [
[
72,
113
]
],
"text": "at 7 days from the beginning of treatment... | [
{
"id": "R1",
"type": "MeasuredAt",
"arg1": "T1",
"arg2": "T2"
},
{
"id": "R2",
"type": "DefinedAs",
"arg1": "T1",
"arg2": "T3"
},
{
"id": "R3",
"type": "DefinedAs",
"arg1": "T9",
"arg2": "T13"
}
] |
100 | silver | Outcomes
Outcomes were assessed at 28 days after randomisation, with further analyses specified at 6 months. The primary outcome was 28-day all-cause mortality. Secondary outcomes were time to discharge from hospital and, among patients not on invasive mechanical ventilation at randomisation, post-enrolment use of inva... | [
{
"id": "T1",
"type": "TimeFrame",
"offsets": [
[
32,
107
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"text": "at 28 days after randomisation, with further analyses specified at 6 months"
},
{
"id": "T2",
"type": "PrimaryOutcome",
"offsets": [
[
140,
159
]
],... | [
{
"id": "R1",
"type": "MeasuredAt",
"arg1": "T3",
"arg2": "T1"
},
{
"id": "R2",
"type": "MeasuredAt",
"arg1": "T4",
"arg2": "T1"
},
{
"id": "R3",
"type": "MeasuredAt",
"arg1": "T2",
"arg2": "T10"
},
{
"id": "R4",
"type": "MeasuredAt",
"arg1": "... |
101 | silver | Outcomes
The primary clinical endpoint was the necessity for intubation and invasive mechanical ventilation. Secondary outcomes were time of invasive mechanical ventilation, admission to the ICU, length of ICU stay, and mortality. | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
48,
108
]
],
"text": "necessity for intubation and invasive mechanical ventilation"
},
{
"id": "T2",
"type": "SecondaryOutcome",
"offsets": [
[
134,
173
]
],
"te... | [] |
102 | silver | Outcomes
The primary outcome was a composite of mechanical ventilation, hospitalization >14 days or in-hospital death.
Secondary outcomes included: days of mechanical ventilation, days of high-flow nasal cannula (HFNC), days of oxygen requirement, time to respiratory failure development (PaO2/FiO2<200), the severity... | [
{
"id": "T2",
"type": "SecondaryOutcome",
"offsets": [
[
151,
181
]
],
"text": "days of mechanical ventilation"
},
{
"id": "T3",
"type": "SecondaryOutcome",
"offsets": [
[
183,
221
]
],
"text": "days of high-flow nas... | [
{
"id": "R1",
"type": "MeasuredAt",
"arg1": "T6",
"arg2": "T7"
},
{
"id": "R2",
"type": "MeasuredAt",
"arg1": "T10",
"arg2": "T11"
},
{
"id": "R3",
"type": "MeasuredAt",
"arg1": "T12",
"arg2": "T13"
},
{
"id": "R4",
"type": "MeasuredAt",
"arg1"... |
103 | silver | Outcomes
The primary outcome was the cumulative lung lesion remission rate (lung CT examination indicated absorption of lung inflammation). Secondary outcomes were the improvement of clinical symptoms (cough, diarrhea, dyspnea, fever, myalgia) before and after treatment; the changes of blood routine test and IL-6; cha... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
38,
75
]
],
"text": "cumulative lung lesion remission rate"
},
{
"id": "T2",
"type": "OutcomeDefinition",
"offsets": [
[
77,
138
]
],
"text": "lung CT examinatio... | [
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"id": "R1",
"type": "DefinedAs",
"arg1": "T1",
"arg2": "T2"
},
{
"id": "R2",
"type": "MeasuredAt",
"arg1": "T3",
"arg2": "T6"
},
{
"id": "R3",
"type": "MeasuredAt",
"arg1": "T7",
"arg2": "T8"
}
] |
104 | silver | Outcomes
The primary outcome was the variation in gas exchange over time evaluated through the ratio of partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2) at baseline, 7, and 14 days after randomization. This ratio was blindly calculated using the result of the arterial blood gas (AB... | [
{
"id": "T2",
"type": "TimeFrame",
"offsets": [
[
191,
238
]
],
"text": "at baseline, 7, and 14 days after randomization"
},
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
39,
74
]
],
"text": "variation in ga... | [
{
"id": "R1",
"type": "DefinedAs",
"arg1": "T1",
"arg2": "T3"
},
{
"id": "R2",
"type": "MeasuredAt",
"arg1": "T1",
"arg2": "T2"
},
{
"id": "R3",
"type": "MeasuredAt",
"arg1": "T5",
"arg2": "T6"
},
{
"id": "R4",
"type": "DefinedAs",
"arg1": "T5"... |
105 | silver | End points
The primary endpoints were the achievement of two successive negative SARS-CoV-2 PCR analysis tests 48 h apart by nasopharyngeal swab, normalization of body temperature for 48 h, improvement of radiological abnormalities at Day 14 and the hospital discharge rate. The secondary endpoints were the normalizat... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
44,
112
]
],
"text": "achievement of two successive negative SARS-CoV-2 PCR analysis tests"
},
{
"id": "T2",
"type": "PrimaryOutcome",
"offsets": [
[
148,
181
]
],
... | [
{
"id": "R1",
"type": "MeasuredAt",
"arg1": "T1",
"arg2": "T5"
},
{
"id": "R2",
"type": "MeasuredAt",
"arg1": "T2",
"arg2": "T6"
},
{
"id": "R3",
"type": "MeasuredAt",
"arg1": "T3",
"arg2": "T7"
}
] |
106 | silver | Outcomes
2.8.1. Primary outcome
The primary endpoint was time to clinical improvement, defined as the days from randomization until normalization. Clinical improvement was assessed by five components including body temperature, respiratory rate, oxygen saturation, alleviation of cough, and absorption of pulmonary inf... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
59,
87
]
],
"text": "time to clinical improvement"
},
{
"id": "T2",
"type": "OutcomeDefinition",
"offsets": [
[
100,
147
]
],
"text": "the days from randomizatio... | [
{
"id": "R1",
"type": "DefinedAs",
"arg1": "T1",
"arg2": "T2"
},
{
"id": "R2",
"type": "DefinedAs",
"arg1": "T1",
"arg2": "T3"
},
{
"id": "R3",
"type": "MeasuredAt",
"arg1": "T8",
"arg2": "T9"
},
{
"id": "R4",
"type": "DefinedAs",
"arg1": "T5",... |
107 | silver | Primary clinical outcome
There was a significant difference in the 28-day mortality, no patient died (0%) in the treatment group, while five patients died (12.8%) in the standard group; P= 0.027 (Fig. 3). Among patients in the treatment arm with bromhexine, two patients were admitted to ICU (5.1%) while in the standar... | [
{
"id": "T2",
"type": "SecondaryOutcome",
"offsets": [
[
952,
1022
]
],
"text": "Improvement of cardinal respiratory symptoms such as cough and dyspnea"
},
{
"id": "T3",
"type": "TimeFrame",
"offsets": [
[
1023,
1039
]
]... | [
{
"id": "R1",
"type": "MeasuredAt",
"arg1": "T2",
"arg2": "T3"
},
{
"id": "R2",
"type": "MeasuredAt",
"arg1": "T10",
"arg2": "T13"
},
{
"id": "R3",
"type": "MeasuredAt",
"arg1": "T12",
"arg2": "T13"
},
{
"id": "R4",
"type": "MeasuredAt",
"arg1"... |
108 | silver | Outcomes
The primary endpoint was the timing to achieve viral RNA negative conversion for SARS-CoV-2 in all three specimens, including nasopharyngeal swabs, throat swabs and stool swabs. When a COVID-19 patient was discharged from hospital, the viral RNA negative conversion of all three specimens needed to be conside... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
40,
187
]
],
"text": "timing to achieve viral RNA negative conversion for SARS-CoV-2 in all three specimens, including nasopharyngeal swabs, throat swabs and stool swabs"
},
{
"id": "T2",
"type": "Seco... | [
{
"id": "R1",
"type": "DefinedAs",
"arg1": "T2",
"arg2": "T3"
},
{
"id": "R2",
"type": "DefinedAs",
"arg1": "T4",
"arg2": "T7"
}
] |
11 | gold | Main outcome measure Negative conversion of severe acute respiratory syndrome coronavirus 2 by 28 days, analysed according to the intention to treat principle. Adverse events were analysed in the safety population in which hydroxychloroquine recipients were participants who received at least one dose of hydroxychloroqu... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
482,
515
]
],
"text": "negative conversion of SARS-CoV-2"
},
{
"id": "T2",
"type": "PrimaryOutcome",
"offsets": [
[
573,
593
]
],
"text": "clinical improvement"
... | [
{
"id": "R2",
"type": "MeasuredAt",
"arg1": "T2",
"arg2": "T4"
},
{
"id": "R3",
"type": "DefinedAs",
"arg1": "T1",
"arg2": "T5"
},
{
"id": "R1",
"type": "MeasuredAt",
"arg1": "T3",
"arg2": "T7"
},
{
"id": "R4",
"type": "MeasuredAt",
"arg1": "T8... |
116 | gold | Study arms and treatment plans
Patients were randomly divided into two treatment groups, a case group comprising 56 patients and a control group comprising 55 patients. On the first day of admission, laboratory studies including complete blood count and erythrocyte sedimentation rate (ESR) were performed. The case gro... | [
{
"id": "T1",
"type": "OtherOutcome",
"offsets": [
[
230,
250
]
],
"text": "complete blood count"
},
{
"id": "T2",
"type": "OtherOutcome",
"offsets": [
[
255,
291
]
],
"text": "erythrocyte sedimentation rate (ESR)"
... | [
{
"id": "R1",
"type": "DefinedAs",
"arg1": "T3",
"arg2": "T4"
},
{
"id": "R2",
"type": "MeasuredAt",
"arg1": "T5",
"arg2": "T9"
},
{
"id": "R3",
"type": "MeasuredAt",
"arg1": "T6",
"arg2": "T9"
},
{
"id": "R4",
"type": "MeasuredAt",
"arg1": "T7... |
117 | gold | Outcome measures
The primary outcome of this study was the rate of hospitalization. Secondary outcomes were clinical improvements (e.g., resolution of fever, cough and dyspnea) and improvement of CT findings at days 14 after initiation of the treatment. Patients were assessed clinically (e.g., temperature, respiratory... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
60,
83
]
],
"text": "rate of hospitalization"
},
{
"id": "T2",
"type": "SecondaryOutcome",
"offsets": [
[
109,
177
]
],
"text": "clinical improvements (e.g., res... | [
{
"id": "R1",
"type": "MeasuredAt",
"arg1": "T2",
"arg2": "T4"
},
{
"id": "R2",
"type": "MeasuredAt",
"arg1": "T3",
"arg2": "T4"
},
{
"id": "R3",
"type": "DefinedAs",
"arg1": "T3",
"arg2": "T5"
},
{
"id": "R4",
"type": "MeasuredAt",
"arg1": "T2... |
12 | gold | Primary outcomes and Secondary outcomes
The primary outcome of this study was the SOFA Score, and the secondary outcome was the all-cause mortality up to 30 days. All outcomes were determined by an independent clinical endpoint determination committee.
| [
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83,
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],
"text": "SOFA Score"
},
{
"id": "T2",
"type": "SecondaryOutcome",
"offsets": [
[
129,
148
]
],
"text": "all-cause mortality"
},
{
"id": "T3",... | [
{
"id": "R1",
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"arg1": "T2",
"arg2": "T3"
}
] |
126 | gold | Abstract. The COVID-19 pandemic is showing an exponential growth, mandating an urgent need to develop an effective treatment. Indeed, to date, a well-established therapy is still lacking. We aimed to evaluate the safety and efficacy of hydroxychloroquine (HCQ) added to standard care in patients with COVID-19. This was... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
763,
771
]
],
"text": "recovery"
},
{
"id": "T2",
"type": "PrimaryOutcome",
"offsets": [
[
788,
819
]
],
"text": "need for mechanical ventilation"
},
{
"... | [
{
"id": "R1",
"type": "MeasuredAt",
"arg1": "T1",
"arg2": "T4"
}
] |
13 | gold | Clinical study
Patients
The study was initially designed as a multi-center study across hospitals in Changsha city and in other cities of Hunan Province,
China. However, per a government order, all patients from hospitals in Changsha city had to be relocated to the First Hospital of Changsha, a designated treatment cen... | [
{
"id": "T1",
"type": "OtherOutcome",
"offsets": [
[
3194,
3235
]
],
"text": "SARS-CoV-2 clearance in COVID-19 patients"
},
{
"id": "T2",
"type": "TimeFrame",
"offsets": [
[
3016,
3051
]
],
"text": "on day three, day... | [
{
"id": "R1",
"type": "MeasuredAt",
"arg1": "T1",
"arg2": "T2"
},
{
"id": "R2",
"type": "DefinedAs",
"arg1": "T1",
"arg2": "T3"
},
{
"id": "R3",
"type": "DefinedAs",
"arg1": "T4",
"arg2": "T5"
},
{
"id": "R4",
"type": "MeasuredAt",
"arg1": "T6"... |
14 | gold | Outcomes
The primary clinical endpoint was time to clinical improvement within 28 days after randomisation. Clinical improvement was defined as a two-point reduction in patients' admission status on a six-point ordinal scale, or live discharge from the hospital, whichever came first. The six-point scale was as follows... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
44,
72
]
],
"text": "time to clinical improvement"
},
{
"id": "T2",
"type": "TimeFrame",
"offsets": [
[
73,
107
]
],
"text": "within 28 days after randomisation"... | [
{
"id": "R1",
"type": "DefinedAs",
"arg1": "T1",
"arg2": "T3"
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{
"id": "R2",
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"arg1": "T1",
"arg2": "T4"
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{
"id": "R3",
"type": "MeasuredAt",
"arg1": "T5",
"arg2": "T6"
},
{
"id": "R4",
"type": "MeasuredAt",
"arg1": "T7"... |
15 | gold | Outcomes
Primary and Secondary Outcomes
The primary efficacy end point was the percentage of subjects with viral negative by Day 14 and the time from randomization to clinical improvement, defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordi... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
80,
122
]
],
"text": "percentage of subjects with viral negative"
},
{
"id": "T2",
"type": "TimeFrame",
"offsets": [
[
123,
132
]
],
"text": "by Day 14"
},
{... | [
{
"id": "R1",
"type": "MeasuredAt",
"arg1": "T1",
"arg2": "T2"
},
{
"id": "R2",
"type": "DefinedAs",
"arg1": "T3",
"arg2": "T4"
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{
"id": "R3",
"type": "MeasuredAt",
"arg1": "T5",
"arg2": "T6"
},
{
"id": "R4",
"type": "MeasuredAt",
"arg1": "T7... |
16 | gold | Outcomes
The primary endpoint was time to achieve a negative RT-PCR result for SARS-CoV-2 in a nasopharyngeal swab sample. Secondary clinical endpoints were time to resolution of symptoms defined as a NEWS2 of 0 maintained for 24 h; daily NEWS2 and sequential organ failure assessment (SOFA) score; length of hospital st... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
34,
121
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],
"text": "time to achieve a negative RT-PCR result for SARS-CoV-2 in a nasopharyngeal swab sample"
},
{
"id": "T2",
"type": "SecondaryOutcome",
"offsets": [
[
157,
... | [
{
"id": "R1",
"type": "DefinedAs",
"arg1": "T2",
"arg2": "T3"
},
{
"id": "R2",
"type": "MeasuredAt",
"arg1": "T8",
"arg2": "T9"
},
{
"id": "R3",
"type": "DefinedAs",
"arg1": "T7",
"arg2": "T13"
},
{
"id": "R4",
"type": "MeasuredAt",
"arg1": "T6... |
19 | gold | Outcomes
The primary outcome was the time to recovery, defined as the first day, during the 28 days after enrollment, on which a patient met the criteria for category 1, 2, or 3 on the eight-category ordinal scale. The categories are as follows: 1, not hospitalized and no limitations of activities; 2, not hospitalize... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
39,
55
]
],
"text": "time to recovery"
},
{
"id": "T2",
"type": "OutcomeDefinition",
"offsets": [
[
68,
215
]
],
"text": "the first day, during the 28 days after... | [
{
"id": "R1",
"type": "DefinedAs",
"arg1": "T1",
"arg2": "T2"
},
{
"id": "R2",
"type": "MeasuredAt",
"arg1": "T3",
"arg2": "T4"
},
{
"id": "R3",
"type": "DefinedAs",
"arg1": "T3",
"arg2": "T5"
},
{
"id": "R4",
"type": "MeasuredAt",
"arg1": "T7"... |
2 | gold | A 4.5 mm fibreoptic bronchoscope (UE Medical Company Ltd, Zhejiang, China) loaded with a lubricated reinforced Parker Flex-Tip® tracheal tube (Well Lead Medical Company Ltd., Guangzhou, China) was inserted until the carina was visualised, and the tube was advanced over the bronchoscope into the trachea. During attempts... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
689,
713
]
],
"text": "total time of intubation"
},
{
"id": "T2",
"type": "OutcomeDefinition",
"offsets": [
[
726,
837
]
],
"text": "the sum of the time spent fr... | [
{
"id": "R1",
"type": "DefinedAs",
"arg1": "T1",
"arg2": "T2"
},
{
"id": "R2",
"type": "MeasuredAt",
"arg1": "T8",
"arg2": "T9"
}
] |
23 | gold | End Points
The primary efficacy end point was clinical status assessed on day 14 on a 7-point ordinal scale consisting of the following categories: 1, death; 2, hospitalized, receiving invasive mechanical ventilation or ECMO; 3, hospitalized, receiving noninvasive ventilation or high-flow oxygen devices; 4, hospitali... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
48,
63
]
],
"text": "clinical status"
},
{
"id": "T2",
"type": "TimeFrame",
"offsets": [
[
73,
82
]
],
"text": "on day 14"
},
{
"id": "T3",
"type": "... | [
{
"id": "R1",
"type": "DefinedAs",
"arg1": "T1",
"arg2": "T3"
},
{
"id": "R2",
"type": "MeasuredAt",
"arg1": "T4",
"arg2": "T5"
},
{
"id": "R3",
"type": "DefinedAs",
"arg1": "T6",
"arg2": "T7"
},
{
"id": "R4",
"type": "DefinedAs",
"arg1": "T8",... |
24 | gold | Outcomes
The primary efficacy end point was the time to clinical improvement, defined as the time from randomization (D0) to an improvement of 2 points on a 7-category ordinal scale or live discharge from the hospital (Dend), and improvement rate of follow-up CT scans at D14. The 7-category ordinal scale has been use... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
50,
78
]
],
"text": "time to clinical improvement"
},
{
"id": "T2",
"type": "OutcomeDefinition",
"offsets": [
[
95,
270
]
],
"text": "time from randomization (D0... | [
{
"id": "R1",
"type": "DefinedAs",
"arg1": "T1",
"arg2": "T2"
},
{
"id": "R2",
"type": "MeasuredAt",
"arg1": "T1",
"arg2": "T3"
},
{
"id": "R3",
"type": "DefinedAs",
"arg1": "T4",
"arg2": "T5"
},
{
"id": "R4",
"type": "MeasuredAt",
"arg1": "T4"... |
25 | silver | ABSTRACT
To the best of our knowledge, there is no published study on the use of interferon-1a (IFN-1a) in the treatment of severe COVID-19. In this randomized clinical trial, the efficacy and safety of IFN-1a were evaluated in patients with severe COVID-19. Forty-two patients in the interferon group received IFN-1a i... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
698,
729
]
],
"text": "time to reach clinical response"
},
{
"id": "T2",
"type": "SecondaryOutcome",
"offsets": [
[
755,
780
]
],
"text": "duration of hospital s... | [
{
"id": "R1",
"type": "MeasuredAt",
"arg1": "T5",
"arg2": "T4"
}
] |
26 | gold | Main Outcomes and Measures Primary outcome was time to clinical improvement within 28 days, defined as patient discharged alive or reduction of 2 points on a 6-point disease severity scale (ranging from 1 [discharge] to 6 [death]). Secondary outcomes included 28-day mortality, time to discharge, and the rate of viral... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
49,
77
]
],
"text": "time to clinical improvement"
},
{
"id": "T2",
"type": "TimeFrame",
"offsets": [
[
78,
92
]
],
"text": "within 28 days"
},
{
"id": "... | [
{
"id": "R1",
"type": "MeasuredAt",
"arg1": "T1",
"arg2": "T2"
},
{
"id": "R2",
"type": "DefinedAs",
"arg1": "T1",
"arg2": "T3"
},
{
"id": "R3",
"type": "MeasuredAt",
"arg1": "T6",
"arg2": "T7"
},
{
"id": "R4",
"type": "DefinedAs",
"arg1": "T5"... |
3 | gold | Outcomes
The primary outcome was the rate of positive-to-negative conversion of SARS-CoV-2 nucleic acid from the initiation of treatment to day 21, with the enrollment day as the first day of treatment. The secondary outcomes were: 1) the rate of positive-to-negative conversion of SARS-CoV-2 nucleic acid at day 14; 2) ... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
37,
103
]
],
"text": "rate of positive-to-negative conversion of SARS-CoV-2 nucleic acid"
},
{
"id": "T2",
"type": "TimeFrame",
"offsets": [
[
104,
146
]
],
"tex... | [
{
"id": "R1",
"type": "MeasuredAt",
"arg1": "T1",
"arg2": "T2"
},
{
"id": "R2",
"type": "MeasuredAt",
"arg1": "T3",
"arg2": "T4"
},
{
"id": "R3",
"type": "DefinedAs",
"arg1": "T5",
"arg2": "T6"
},
{
"id": "R4",
"type": "MeasuredAt",
"arg1": "T5... |
34 | gold | Outcome Measures
The primary outcome was all-cause mortality within 28 days after randomization; further analyses were specified at 6 months. Secondary outcomes were the time until discharge from the hospital and, among patients not receiving invasive mechanical ventilation at the time of randomization, subsequent re... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
43,
62
]
],
"text": "all-cause mortality"
},
{
"id": "T2",
"type": "TimeFrame",
"offsets": [
[
63,
142
]
],
"text": "within 28 days after randomization; further ... | [
{
"id": "R1",
"type": "MeasuredAt",
"arg1": "T1",
"arg2": "T2"
},
{
"id": "R3",
"type": "DefinedAs",
"arg1": "T5",
"arg2": "T10"
}
] |
37 | gold | Outcomes
The primary outcome measurement for this study was time to clinical recovery (TTCR), defined as the number of days from randomization to clinical recovery. Maximum TTCR was 28 days. Patients were considered to have achieved clinical recovery when they had met all of the following criteria for at least 48 hou... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
62,
94
]
],
"text": "time to clinical recovery (TTCR)"
},
{
"id": "T2",
"type": "OutcomeDefinition",
"offsets": [
[
107,
165
]
],
"text": "the number of days fro... | [
{
"id": "R1",
"type": "DefinedAs",
"arg1": "T1",
"arg2": "T2"
},
{
"id": "R2",
"type": "DefinedAs",
"arg1": "T1",
"arg2": "T3"
},
{
"id": "R3",
"type": "MeasuredAt",
"arg1": "T1",
"arg2": "T5"
},
{
"id": "R4",
"type": "DefinedAs",
"arg1": "T6",... |
4 | gold | Outcome Measures
The primary end point was the time to clinical improvement, defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever came first. The end point of clinical improvement was u... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
48,
76
]
],
"text": "time to clinical improvement"
},
{
"id": "T2",
"type": "OutcomeDefinition",
"offsets": [
[
93,
275
]
],
"text": "time from randomization to ... | [
{
"id": "R1",
"type": "DefinedAs",
"arg1": "T1",
"arg2": "T2"
},
{
"id": "R2",
"type": "DefinedAs",
"arg1": "T3",
"arg2": "T4"
},
{
"id": "R3",
"type": "MeasuredAt",
"arg1": "T3",
"arg2": "T5"
},
{
"id": "R4",
"type": "MeasuredAt",
"arg1": "T6"... |
43 | gold | Main Outcomes and Measures Primary end points were (1) maximum high-sensitivity cardiac troponin level; (2) time for C-reactive protein to reach more than 3 times the upper reference limit; and (3) time to deterioration by 2 points on a 7-grade clinical status scale, ranging from able to resume normal activities to d... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
57,
104
]
],
"text": "maximum high-sensitivity cardiac troponin level"
},
{
"id": "T2",
"type": "PrimaryOutcome",
"offsets": [
[
110,
190
]
],
"text": "time for ... | [
{
"id": "R2",
"type": "MeasuredAt",
"arg1": "T11",
"arg2": "T12"
},
{
"id": "R1",
"type": "DefinedAs",
"arg1": "T14",
"arg2": "T15"
},
{
"id": "R3",
"type": "MeasuredAt",
"arg1": "T14",
"arg2": "T9"
}
] |
45 | gold | Intervention, primary and secondary endpoints
Patients were randomly assigned via a web-based system at a 1:1 ratio to the current standard of care at each hospital with or without the addition of 300ml of ConvP, the standard volume of one plasma unit produced by Sanquin Blood Supply, was administered intravenously on... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
934,
951
]
],
"text": "overall mortality"
},
{
"id": "T2",
"type": "TimeFrame",
"offsets": [
[
952,
1046
]
],
"text": "until discharge from the hospital or a max... | [
{
"id": "R1",
"type": "MeasuredAt",
"arg1": "T1",
"arg2": "T2"
},
{
"id": "R2",
"type": "MeasuredAt",
"arg1": "T5",
"arg2": "T4"
},
{
"id": "R3",
"type": "MeasuredAt",
"arg1": "T3",
"arg2": "T8"
}
] |
47 | silver | End Points
The primary end point was viral clearance rate at day 7 after randomization. After randomization, respiratory samples were collected every 1–2 days until viral clearance. Viral clearance was defined as reverse transcriptase polymerase chain reaction (RT-PCR) negative on at least 2 consecutive oropharyngeal ... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
38,
58
]
],
"text": "viral clearance rate"
},
{
"id": "T2",
"type": "TimeFrame",
"offsets": [
[
59,
87
]
],
"text": "at day 7 after randomization"
},
{
"... | [
{
"id": "R1",
"type": "MeasuredAt",
"arg1": "T1",
"arg2": "T2"
},
{
"id": "R2",
"type": "DefinedAs",
"arg1": "T1",
"arg2": "T3"
},
{
"id": "R3",
"type": "MeasuredAt",
"arg1": "T4",
"arg2": "T5"
},
{
"id": "R4",
"type": "MeasuredAt",
"arg1": "T6... |
48 | silver | Outcome measures
Outcomes were assessed at 28 days after randomization, with further analyses specified at 6 months. The primary outcome was all-cause mortality. Secondary outcomes were time to discharge from hospital and, among patients not on invasive mechanical ventilation at randomization, invasive mechanical venti... | [
{
"id": "T1",
"type": "TimeFrame",
"offsets": [
[
40,
115
]
],
"text": "at 28 days after randomization, with further analyses specified at 6 months"
},
{
"id": "T3",
"type": "PrimaryOutcome",
"offsets": [
[
141,
160
]
],... | [
{
"id": "R1",
"type": "MeasuredAt",
"arg1": "T3",
"arg2": "T1"
},
{
"id": "R3",
"type": "MeasuredAt",
"arg1": "T4",
"arg2": "T1"
},
{
"id": "R5",
"type": "MeasuredAt",
"arg1": "T5",
"arg2": "T1"
},
{
"id": "R7",
"type": "MeasuredAt",
"arg1": "T... |
49 | silver | Outcomes
The primary outcome was the reduction of viral RNA load in nasopharyngeal swabs at days 3 and 7 after treatment start. The secondary outcomes were clinical progression measured using a simplified version of the WHO progression scale [17] (1, not hospitalized with or without resumption of normal activities; 2... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
39,
66
]
],
"text": "reduction of viral RNA load"
},
{
"id": "T2",
"type": "TimeFrame",
"offsets": [
[
91,
128
]
],
"text": "at days 3 and 7 after treatment star... | [
{
"id": "R1",
"type": "MeasuredAt",
"arg1": "T1",
"arg2": "T2"
},
{
"id": "R2",
"type": "MeasuredAt",
"arg1": "T4",
"arg2": "T5"
},
{
"id": "R3",
"type": "DefinedAs",
"arg1": "T4",
"arg2": "T6"
},
{
"id": "R4",
"type": "DefinedAs",
"arg1": "T7"... |
5 | silver | Abstract
Objective: To evaluate the efficacy and safety of hydroxychloroquine (HCQ) in the treatment of patients with moderate coronavirus disease 2019 (COVID-19). Methods: We prospectively enrolled 30 treatment-naïve patients with confirmed COVID-19 after informed consent at Shanghai Public Health Clinical Center. ... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
582,
628
]
],
"text": "negative conversion rate of SARS-CoV-2 nucleic"
},
{
"id": "T2",
"type": "TimeFrame",
"offsets": [
[
665,
694
]
],
"text": "on days 7 afte... | [
{
"id": "R1",
"type": "MeasuredAt",
"arg1": "T1",
"arg2": "T2"
}
] |
50 | silver | Measurements:
Symptoms and severity at baseline and then at days 3, 5, 10, and 14 using a 10-point visual analogue scale. The primary end point was change in overall symptom severity over 14 days.
Study End Points
The initial primary outcome was an ordinal outcome by day 14 of not hospitalized, hospitalized, or inte... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
1047,
1081
]
],
"text": "change in overall symptom severity"
},
{
"id": "T2",
"type": "TimeFrame",
"offsets": [
[
1082,
1094
]
],
"text": "over 14 days"
},
{... | [
{
"id": "R1",
"type": "MeasuredAt",
"arg1": "T1",
"arg2": "T2"
},
{
"id": "R2",
"type": "MeasuredAt",
"arg1": "T3",
"arg2": "T4"
},
{
"id": "R3",
"type": "MeasuredAt",
"arg1": "T5",
"arg2": "T6"
},
{
"id": "R4",
"type": "MeasuredAt",
"arg1": "T... |
51 | silver | Outcomes
The primary outcome was clinical status at 15 days, evaluated with the use of a seven-level ordinal scale. Scores on the scale were defined as follows: a score of 1 indicated not hospitalized with no limitations on activities; 2, not hospitalized but with limitations on activities; 3, hospitalized and not re... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
35,
50
]
],
"text": "clinical status"
},
{
"id": "T2",
"type": "TimeFrame",
"offsets": [
[
51,
61
]
],
"text": "at 15 days"
},
{
"id": "T3",
"type": ... | [
{
"id": "R1",
"type": "MeasuredAt",
"arg1": "T1",
"arg2": "T2"
},
{
"id": "R2",
"type": "DefinedAs",
"arg1": "T1",
"arg2": "T3"
},
{
"id": "R3",
"type": "MeasuredAt",
"arg1": "T4",
"arg2": "T5"
},
{
"id": "R4",
"type": "MeasuredAt",
"arg1": "T6... |
52 | silver | Abstract
Background. Interventions mitigating progression to mechanical ventilation in COVID 19 would markedly improve outcome and reduce healthcare utilization. We hypothesized that immunomodulation with IVIG would improve oxygenation and reduce length of hospital stay and progression to mechanical ventilation in COV... | [
{
"id": "T1",
"type": "OtherOutcome",
"offsets": [
[
1628,
1650
]
],
"text": "mechanical ventilation"
},
{
"id": "T2",
"type": "OtherOutcome",
"offsets": [
[
3369,
3402
]
],
"text": "Alveolar arterial (A a) gradients... | [] |
53 | silver | Outcomes assessment: The primary outcomes included virological and clinical evaluations.
Time to SARS-CoV-2 RNA negativization (absence of the virus according to the RT-PCR) in positive patients after starting antiviral therapy was the virological endpoint. It was expressed as the percentage of patients negative to SA... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
90,
127
]
],
"text": "Time to SARS-CoV-2 RNA negativization"
},
{
"id": "T2",
"type": "OutcomeDefinition",
"offsets": [
[
128,
173
]
],
"text": "(absence of the ... | [
{
"id": "R1",
"type": "DefinedAs",
"arg1": "T1",
"arg2": "T2"
},
{
"id": "R2",
"type": "DefinedAs",
"arg1": "T1",
"arg2": "T3"
},
{
"id": "R3",
"type": "MeasuredAt",
"arg1": "T1",
"arg2": "T4"
},
{
"id": "R4",
"type": "DefinedAs",
"arg1": "T5",... |
54 | silver | The objective of the pilot stage of the study was a preliminary assessment of the efficacy and safety of AVIFAVIR, and to select the optimal dosing regimen for further evaluation at the pivotal stage (Phase III). The primary efficacy endpoint at the pilot stage was the elimination of SARS-CoV-2 by Day 10 (defined as tw... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
270,
295
]
],
"text": "elimination of SARS-CoV-2"
},
{
"id": "T2",
"type": "TimeFrame",
"offsets": [
[
296,
305
]
],
"text": "by Day 10"
},
{
"id": "T3",... | [
{
"id": "R1",
"type": "MeasuredAt",
"arg1": "T1",
"arg2": "T2"
},
{
"id": "R2",
"type": "DefinedAs",
"arg1": "T1",
"arg2": "T3"
},
{
"id": "R3",
"type": "MeasuredAt",
"arg1": "T6",
"arg2": "T7"
},
{
"id": "R4",
"type": "MeasuredAt",
"arg1": "T8... |
55 | silver | Outcome measurement
The primary endpoint was to evaluate the efficacy of HCQ with respect to time to negative rRT-PCR assessments from randomization up to 14 days. The secondary endpoints were to evaluate the proportion of negative viral rRT-PCR on hospital day 14, the resolution of clinical symptoms (time to clinical... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
62,
130
]
],
"text": "efficacy of HCQ with respect to time to negative rRT-PCR assessments"
},
{
"id": "T2",
"type": "TimeFrame",
"offsets": [
[
131,
163
]
],
"t... | [
{
"id": "R1",
"type": "MeasuredAt",
"arg1": "T1",
"arg2": "T2"
},
{
"id": "R2",
"type": "MeasuredAt",
"arg1": "T3",
"arg2": "T4"
},
{
"id": "R3",
"type": "MeasuredAt",
"arg1": "T6",
"arg2": "T7"
}
] |
56 | silver | Outcomes
The primary outcome was the difference in the interval from baseline (initiation of antiviral treatment) to SARS-CoV-2 nucleic acid negativity by nasopharyngeal swab among the three antiviral treatment groups, with each of these two tests at least 24 h apart. The secondary outcomes included the differences am... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
38,
218
]
],
"text": "difference in the interval from baseline (initiation of antiviral treatment) to SARS-CoV-2 nucleic acid negativity by nasopharyngeal swab among the three antiviral treatment groups"
},
{
... | [
{
"id": "R1",
"type": "MeasuredAt",
"arg1": "T2",
"arg2": "T7"
},
{
"id": "R2",
"type": "MeasuredAt",
"arg1": "T3",
"arg2": "T8"
},
{
"id": "R3",
"type": "DefinedAs",
"arg1": "T1",
"arg2": "T9"
}
] |
57 | silver | Methods:
Trial Design and Participants:
It is an open label, randomized clinical trial conducted at Bahria International Hospital, Lahore, to evaluate the effects of a combination therapy including Dexamethasone and Aprepitant in hospitalized patients with Covid-19. The trial was conducted in accordance with the princ... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
1274,
1296
]
],
"text": "total in hospital days"
},
{
"id": "T2",
"type": "PrimaryOutcome",
"offsets": [
[
1305,
1324
]
],
"text": "duration of disease"
},
{... | [] |
59 | silver | Outcomes
The primary outcome was 28-day mortality. Secondary endpoints included early mortality (Days 7 and 14), the need for orotracheal intubation by Day 7, and the proportion of patients with an oxygenation index (PaO2/FiO2) < 100 by Day 7. Post hoc exploratory analyses were for mortality rates in subgroups (wheth... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
42,
51
]
],
"text": "mortality"
},
{
"id": "T2",
"type": "SecondaryOutcome",
"offsets": [
[
82,
97
]
],
"text": "early mortality"
},
{
"id": "T3",
"t... | [
{
"id": "R1",
"type": "MeasuredAt",
"arg1": "T2",
"arg2": "T3"
},
{
"id": "R2",
"type": "MeasuredAt",
"arg1": "T4",
"arg2": "T5"
},
{
"id": "R3",
"type": "MeasuredAt",
"arg1": "T6",
"arg2": "T7"
},
{
"id": "R4",
"type": "MeasuredAt",
"arg1": "T... |
6 | silver | Endpoints
5 days after enrollment or severe adverse reactions appeared was the observation endpoint. Changes in time to clinical recovery (TTCR) and clinical characteristics of patients were evaluated after administration. TTCR is defined as the return of body temperature and cough relief, maintained for more than 72 ... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
11,
71
]
],
"text": "5 days after enrollment or severe adverse reactions appeared"
},
{
"id": "T2",
"type": "OtherOutcome",
"offsets": [
[
102,
145
]
],
"text": ... | [
{
"id": "R1",
"type": "DefinedAs",
"arg1": "T2",
"arg2": "T4"
},
{
"id": "R2",
"type": "MeasuredAt",
"arg1": "T5",
"arg2": "T6"
},
{
"id": "R3",
"type": "DefinedAs",
"arg1": "T5",
"arg2": "T7"
}
] |
60 | silver |
Outcomes
The primary outcomes were the rate of nucleic acid negativity conversion of SARS-CoV-2 and the negativity conversion time. Nucleic acid conversion rate was defined as the ratio of patients with negativity nucleic acid testing in FNC group to all patients in FNC group at a certain point in the follow-up proc... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
42,
98
]
],
"text": "rate of nucleic acid negativity conversion of SARS-CoV-2"
},
{
"id": "T2",
"type": "PrimaryOutcome",
"offsets": [
[
107,
133
]
],
"text": "n... | [
{
"id": "R1",
"type": "DefinedAs",
"arg1": "T1",
"arg2": "T3"
},
{
"id": "R2",
"type": "DefinedAs",
"arg1": "T4",
"arg2": "T7"
}
] |
61 | silver | End points
All AEs, serious and non-serious, were to be reported. Immediately reportable serious adverse events included adverse events that resulted in death and new life-threatening events. The primary outcome was defined as relative change (%) from baseline (day 1 prior to study drug administration at ± 1h of rando... | [
{
"id": "T1",
"type": "OtherOutcome",
"offsets": [
[
12,
44
]
],
"text": "All AEs, serious and non-serious"
},
{
"id": "T2",
"type": "PrimaryOutcome",
"offsets": [
[
228,
367
]
],
"text": "relative change (%) from ba... | [
{
"id": "R1",
"type": "MeasuredAt",
"arg1": "T2",
"arg2": "T3"
}
] |
62 | silver | Outcomes
Reductions of C reactive protein levels at day 5 and 8 after randomization were chosen as primary outcome. Secondary outcomes included admission to ICU within 15 and 30 days from randomization, occurrence of mechanical ventilation within 15 and 30 days from randomization, death within 15 and 30 days from rand... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
10,
49
]
],
"text": "Reductions of C reactive protein levels"
},
{
"id": "T2",
"type": "TimeFrame",
"offsets": [
[
50,
84
]
],
"text": "at day 5 and 8 after rand... | [
{
"id": "R1",
"type": "MeasuredAt",
"arg1": "T1",
"arg2": "T2"
},
{
"id": "R2",
"type": "MeasuredAt",
"arg1": "T3",
"arg2": "T4"
},
{
"id": "R3",
"type": "MeasuredAt",
"arg1": "T5",
"arg2": "T6"
},
{
"id": "R4",
"type": "MeasuredAt",
"arg1": "T... |
63 | silver | Outcomes. The primary outcome was the time to clinical improvement (TTCI) as defined by the Cap-China Network 57, which was employed in the LOTUS China trial 11 and recommended by the World Health Organization. TTCI refers to the time from randomization to an improvement of two points on the seven-category ordinal sca... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
39,
74
]
],
"text": "time to clinical improvement (TTCI)"
},
{
"id": "T2",
"type": "OutcomeDefinition",
"offsets": [
[
78,
777
]
],
"text": "defined by the Cap-C... | [
{
"id": "R1",
"type": "DefinedAs",
"arg1": "T1",
"arg2": "T2"
},
{
"id": "R2",
"type": "MeasuredAt",
"arg1": "T3",
"arg2": "T4"
},
{
"id": "R3",
"type": "DefinedAs",
"arg1": "T10",
"arg2": "T11"
}
] |
64 | silver | Main Outcomes and Measures The primary end point was clinical status on day 11 on a 7-point ordinal scale ranging from death (category 1) to discharged (category 7). Differences between remdesivir treatment groups and standard care were calculated using proportional odds models and expressed as odds ratios. An odds r... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
55,
70
]
],
"text": "clinical status"
},
{
"id": "T2",
"type": "TimeFrame",
"offsets": [
[
71,
80
]
],
"text": "on day 11"
},
{
"id": "T3",
"type": "... | [
{
"id": "R1",
"type": "DefinedAs",
"arg1": "T1",
"arg2": "T3"
},
{
"id": "R2",
"type": "MeasuredAt",
"arg1": "T1",
"arg2": "T2"
},
{
"id": "R3",
"type": "MeasuredAt",
"arg1": "T4",
"arg2": "T5"
},
{
"id": "R4",
"type": "MeasuredAt",
"arg1": "T6... |
65 | silver | Methods A randomized, controlled, open-label study of Auxora was conducted in adults with severe or critical COVID-19 pneumonia. Patients were randomized 2:1 to receive three doses of once-daily Auxora versus standard of care (SOC) alone. The primary objective was to assess the safety and tolerability of Auxora. Foll... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
281,
314
]
],
"text": "safety and tolerability of Auxora"
}
] | [] |
66 | silver | Outcomes
The primary endpoint of this trial was clinical recovery within 14 days of enrolment. Clinical recovery was defined as normalization of fever (≤37.2°C), respiratory rate (≤24/min) and oxygen saturation (≥94%) without supplementary oxygen therapy sustained for at least 24 h. If patients maintained these crite... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
50,
67
]
],
"text": "clinical recovery"
},
{
"id": "T2",
"type": "TimeFrame",
"offsets": [
[
68,
95
]
],
"text": "within 14 days of enrolment"
},
{
"id":... | [
{
"id": "R1",
"type": "MeasuredAt",
"arg1": "T1",
"arg2": "T2"
},
{
"id": "R2",
"type": "DefinedAs",
"arg1": "T1",
"arg2": "T3"
}
] |
67 | silver | Outcome
The primary outcome measure was a composite endpoint that included in-hospital all-cause mortality, escalation to ICU admission, or progression of respiratory insufficiency that required non-invasive ventilation (NIV).
The secondary outcomes were the effects on the individual components of the composite endpoi... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
76,
226
]
],
"text": "in-hospital all-cause mortality, escalation to ICU admission, or progression of respiratory insufficiency that required non-invasive ventilation (NIV)"
},
{
"id": "T2",
"type": "S... | [
{
"id": "R1",
"type": "MeasuredAt",
"arg1": "T3",
"arg2": "T4"
},
{
"id": "R2",
"type": "MeasuredAt",
"arg1": "T2",
"arg2": "T4"
}
] |
68 | silver | Clinical outcome assessment
The patients were observed for 2 weeks after hUC-MSC infusion, and clinical symptoms, laboratory tests, and radiological results were recorded and confirmed by experienced physicians. The primary clinical outcomes included the incidence of progression from severe to critical illness and th... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
257,
313
]
],
"text": "incidence of progression from severe to critical illness"
},
{
"id": "T2",
"type": "PrimaryOutcome",
"offsets": [
[
322,
394
]
],
"text": ... | [
{
"id": "R1",
"type": "MeasuredAt",
"arg1": "T3",
"arg2": "T4"
}
] |
69 | silver | Outcomes
The primary outcome of the study was length of hospital stay. Secondary outcomes included the frequency of ICU admission, invasive mechanical ventilation, duration of ICU admission, mechanical ventilation and, finally, the frequency and time to recovery, defined as hospital discharge alive. | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
48,
71
]
],
"text": "length of hospital stay"
},
{
"id": "T2",
"type": "SecondaryOutcome",
"offsets": [
[
105,
131
]
],
"text": "frequency of ICU admission"
},... | [
{
"id": "R1",
"type": "DefinedAs",
"arg1": "T6",
"arg2": "T7"
}
] |
70 | silver | Data collection and management
Baseline data, which included demographics, anthropometrics, comorbid conditions, vital signs, Acute Physiology and Chronic Health Evaluation II (APACHE II) scores, and Glasgow coma scale (GCS) scores, were obtained on the day of randomization. Laboratory data, sequential organ failure ... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
529,
543
]
],
"text": "IMV- free days"
},
{
"id": "T2",
"type": "TimeFrame",
"offsets": [
[
544,
554
]
],
"text": "in 28 days"
},
{
"id": "T3",
"type... | [
{
"id": "R1",
"type": "MeasuredAt",
"arg1": "T1",
"arg2": "T2"
},
{
"id": "R2",
"type": "DefinedAs",
"arg1": "T8",
"arg2": "T13"
},
{
"id": "R3",
"type": "DefinedAs",
"arg1": "T10",
"arg2": "T14"
},
{
"id": "R4",
"type": "DefinedAs",
"arg1": "T... |
71 | silver | Main Outcomes and Measures The primary outcome, treatment failure on day 21, was defined as death or persistent dependency on mechanical ventilation or high-flow oxygen therapy. Prespecified secondary outcomes included the need for tracheal intubation (among patients not intubated at baseline); cumulative incidences (... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
49,
66
]
],
"text": "treatment failure"
},
{
"id": "T2",
"type": "TimeFrame",
"offsets": [
[
67,
76
]
],
"text": "on day 21"
},
{
"id": "T3",
"type":... | [
{
"id": "R1",
"type": "MeasuredAt",
"arg1": "T1",
"arg2": "T2"
},
{
"id": "R2",
"type": "DefinedAs",
"arg1": "T1",
"arg2": "T3"
},
{
"id": "R3",
"type": "MeasuredAt",
"arg1": "T6",
"arg2": "T7"
},
{
"id": "R4",
"type": "MeasuredAt",
"arg1": "T9... |
72 | silver | Main Outcomes and Measures The primary end point was organ support–free days (days alive and free of ICU-based respiratory or cardiovascular support) within 21 days, where patients who died were assigned –1 day. The primary analysis was a bayesian cumulative logistic model that included all patients enrolled with sev... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
55,
78
]
],
"text": "organ support–free days"
},
{
"id": "T2",
"type": "OutcomeDefinition",
"offsets": [
[
80,
150
]
],
"text": "days alive and free of ICU-based... | [
{
"id": "R1",
"type": "DefinedAs",
"arg1": "T1",
"arg2": "T2"
},
{
"id": "R2",
"type": "MeasuredAt",
"arg1": "T1",
"arg2": "T3"
},
{
"id": "R3",
"type": "MeasuredAt",
"arg1": "T9",
"arg2": "T10"
}
] |
73 | silver | Procedures and Outcomes
Patients were registered, after giving informed consent to participate, in a web-based eCRF (ORACLE clinical), their baseline clinical data collected and then randomly assigned 1:1 to the investigational treatment, stratified by study site. CP had to be administered immediately after randomizat... | [
{
"id": "T1",
"type": "PrimaryOutcome",
"offsets": [
[
976,
1022
]
],
"text": "proportion of patients in categories 5, 6 or 7"
},
{
"id": "T2",
"type": "TimeFrame",
"offsets": [
[
1023,
1045
]
],
"text": "at day 15 o... | [
{
"id": "R1",
"type": "MeasuredAt",
"arg1": "T1",
"arg2": "T2"
},
{
"id": "R2",
"type": "DefinedAs",
"arg1": "T1",
"arg2": "T3"
},
{
"id": "R4",
"type": "MeasuredAt",
"arg1": "T16",
"arg2": "T17"
},
{
"id": "R5",
"type": "MeasuredAt",
"arg1": "... |
End of preview. Expand in Data Studio
Primary and Secondary Outcomes Manually Annotated Corpus
Corpus :
86 COVID-19 Randomized Controlled Trials articles. For each article, a part of the full text or abstract supposed to contain information about Clinical Trial Outcomes have been extracted using Entrez API , a XML parser for the Entrez article format, and then multiple regular expression to detect outcome sections. The goal was to annotate entities and relations useful for the detection of discrepancies between clinical trial registration and publication, which includes :
- Change in timing of the assessment of the primary outcome
- New primary outcome introduced in the paper
- Registered primary outcome not reported in the paper
- Registered primary endpoint reported as secondary outcome in the paper
- Registered secondary outcome reported as a primary outcome in the paper
Annotators :
2 Master students in Epidemiology and Statistics annotated Entities and Relations using brat. A third annotator (PhD Student in NLP, with basic knowledge about clinical trials) did the adjudication.
Associated resources
The code used to process this corpus is available publicly on github
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