id stringlengths 36 36 | Type stringclasses 2
values | Section_id stringclasses 4
values | Primary_id stringlengths 11 11 | Secondary_id stringlengths 11 11 ⌀ | Statement stringlengths 48 301 | Label stringclasses 2
values | Primary_evidence_index listlengths 1 39 | Secondary_evidence_index listlengths 1 68 ⌀ | Primary_Document dict | Primary_Section listlengths 2 55 | Secondary_Document dict | Secondary_Section listlengths 2 68 ⌀ | reasoning_types listlengths 1 3 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
9f978634-637c-472f-a588-6f4bb2fb121f | Comparison | Eligibility | NCT01129622 | NCT01156987 | Women suffering from both claustrophobia and IBS or not eligible for either the primary trial or the secondary trial. | Contradiction | [
2,
3
] | [
2,
9
] | {
"Adverse Events": [
"Adverse Events 1:",
" Total: 0/14 (0.00%)"
],
"Eligibility": [
"Inclusion Criteria:",
" Women are eligible to participate if they are 40 years or older and have been menopausal (had no menstrual bleeding during the past 12 months)",
"Exclusion Criteria:",
" Histor... | [
"Inclusion Criteria:",
" Women are eligible to participate if they are 40 years or older and have been menopausal (had no menstrual bleeding during the past 12 months)",
"Exclusion Criteria:",
" History of bilateral mastectomy, osteoporosis or renal impairment."
] | {
"Adverse Events": [
"Adverse Events 1:",
" Total: 0/8 (0.00%)",
"Adverse Events 2:",
" Total: 0/23 (0.00%)"
],
"Eligibility": [
"Inclusion Criteria:",
" Women with a clinically or mammographically identified suspicious breast mass that is likely to be biopsied or surgically removed.",... | [
"Inclusion Criteria:",
" Women with a clinically or mammographically identified suspicious breast mass that is likely to be biopsied or surgically removed.",
"Exclusion Criteria:",
" Pregnancy",
" Ferromagnetic implants",
" History of shotgun wounds and shrapnel",
" Obesity (>250 pounds)",
" Car... | [
"Clinical",
"Existence"
] |
20b34e62-97c2-4ca0-bb1d-7824dab0b8bb | Single | Eligibility | NCT00322374 | null | There are no conditions on mental mental health, bodyweight, size of tumours, Karnofsky/ECOG score or Estimated life expectancy that need to be met in order to be eligible for the primary trial | Entailment | [
0,
1,
2,
3,
4,
5
] | null | {
"Adverse Events": [
"Adverse Events 1:",
" Total: 2/6 (33.33%)",
" ANAEMIA 0/6 (0.00%)",
" NEUTROPENIA 0/6 (0.00%)",
" FEBRILE NEUTROPENIA 0/6 (0.00%)",
" FEBRILE BONE MARROW APLASIA 0/6 (0.00%)",
" NAUSEA 0/6 (0.00%)",
" VOMITING 1/6 (16.67%)",
" PYREXIA 0/6 (0.00%)",
... | [
"Inclusion Criteria:",
" Women 18 years",
" Histologically or cytologically confirmed diagnosis of metastatic breast cancer",
" Measurable or nonmeasurable disease defined by Response Evaluation Criteria In Solid Tumors (RECIST)",
"Exclusion Criteria:",
" Number of prior chemotherapy lines of treatmen... | null | null | [
"Paraphrase",
"Existence"
] |
893a5337-2aa9-4a87-a020-4c2f03cd4aea | Comparison | Eligibility | NCT00122369 | NCT03069313 | the secondary trial requires patients to be over a certain age, but the primary trial does not specify an age range for participation. | Entailment | [
0,
1,
2,
3,
4,
5
] | [
0,
1,
2,
3,
4,
5,
6,
7
] | {
"Adverse Events": [
"Adverse Events 1:",
" Total: 0/76 (0.00%)",
"Adverse Events 2:",
" Total: "
],
"Eligibility": [
"Inclusion Criteria:",
" Patients presenting for large core breast biopsy in the Radiology Department at the Beth Israel Deaconess Medical Center Boston.",
"Exclusi... | [
"Inclusion Criteria:",
" Patients presenting for large core breast biopsy in the Radiology Department at the Beth Israel Deaconess Medical Center Boston.",
"Exclusion Criteria:",
" Patients are excluded if :",
" They are unable to give informed consent, or pass screening for impaired mental function or p... | {
"Adverse Events": [
"Adverse Events 1:",
" Total: 0/36 (0.00%)"
],
"Eligibility": [
"Inclusion Criteria:",
" Sign informed consent and Pain level > 4 in the BPI scale,",
" Stage I-III",
"Exclusion Criteria:",
" <18 yrs",
" Stage IV",
" BPI Score <4",
"Zubrod score >... | [
"Inclusion Criteria:",
" Sign informed consent and Pain level > 4 in the BPI scale,",
" Stage I-III",
"Exclusion Criteria:",
" <18 yrs",
" Stage IV",
" BPI Score <4",
"Zubrod score >2"
] | [
"Paraphrase"
] |
d401affc-f081-4eee-bd61-d109cc88f6de | Comparison | Eligibility | NCT04080297 | NCT00929240 | Patients currently taking part in the secondary trial are not eligible to enroll in the primary trial at the same time | Entailment | [
12
] | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9
] | {
"Adverse Events": [
"Adverse Events 1:",
" Total: 0/10 (0.00%)",
" Breast pain 0/10 (0.00%)",
"Adverse Events 2:",
" Total: 1/11 (9.09%)",
" Breast pain 1/11 (9.09%)"
],
"Eligibility": [
"Inclusion Criteria:",
" Be a female of any race between the ages of 30-70 years.",
... | [
"Inclusion Criteria:",
" Be a female of any race between the ages of 30-70 years.",
" History of breast cancer and presently taking an aromatase inhibitor or tamoxifen.",
" Naturally menopausal: 12 months spontaneous amenorrhea or > 6 but < 12 months amenorrhea with a serum follicle stimulating hormone (F... | {
"Adverse Events": [
"Adverse Events 1:",
" Total: 78/284 (27.46%)",
" Febrile neutropenia * 28/284 (9.86%)",
" Neutropenia * 217/284 (5.99%)",
" Leukopenia * 23/284 (1.06%)",
" Anaemia * 22/284 (0.70%)",
" Thrombocytopenia * 20/284 (0.00%)",
" Myocardial infarction * 20/284 (0... | [
"Inclusion Criteria:",
" adult patients, >=18 years of age;",
" HER2-negative metastatic breast cancer",
" candidates for taxane-based chemotherapy;",
" ECOG performance status of 0 or 1.",
"Exclusion Criteria:",
" previous chemotherapy for metastatic breast cancer;",
" prior adjuvant/neo-adjuva... | [
"Paraphrase"
] |
791790a6-187b-4e4b-be5f-9e5304e9ec2c | Comparison | Intervention | NCT01301729 | NCT00021255 | HER2 + Patients in the primary trial receive the same dosage of Trastuzumab as patients in cohort 2 of the secondary trial throughout the entire duration of the trial | Contradiction | [
0,
1,
2
] | [
3,
4,
5
] | {
"Adverse Events": [
"Adverse Events 1:",
" Total: 5/32 (15.63%)",
" Leukopenia 1/32 (3.13%)",
" Neutropenia 1/32 (3.13%)",
" Cataract 1/32 (3.13%)",
" Infection 1/32 (3.13%)",
" Upper respiratory tract infection 1/32 (3.13%)",
" Completed suicide 1/32 (3.13%)"
],
"Eligibil... | [
"INTERVENTION 1: ",
" Trastuzumab",
" Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or pac... | {
"Adverse Events": [
"Adverse Events 1:",
" Total: 218/1018 (21.41%)",
" ANEMIA 1/1018 (0.10%)",
" LEUKOPENIA 21/1018 (2.06%)",
" LYMPHEDEMA 0/1018 (0.00%)",
" PANCYTOPENIA 1/1018 (0.10%)",
" THROMBOCYTOPENIA 0/1018 (0.00%)",
" ANGINA PECTORIS 0/1018 (0.00%)",
" AORTIC STE... | [
"INTERVENTION 1: ",
" Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)",
" Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycl... | [
"Numerical_Comp",
"Paraphrase"
] |
b95b7438-ec16-4d4d-826d-5891e7982b36 | Comparison | Adverse Events | NCT00766532 | NCT01468675 | There are no cases of anorexia, hypothermia or hallucinations recorded in the Aes of the primary trial or the secondary trial. | Entailment | [
0,
1
] | [
0,
1,
2,
3
] | {
"Adverse Events": [
"Adverse Events 1:",
" Total: 0/10 (0.00%)"
],
"Eligibility": [
"Inclusion Criteria:",
" Women at least 5 years past menopause, defined as date of last menses or bilateral oophorectomy",
" Newly diagnosed breast cancer and starting an AI as initial adjuvant therapy",
... | [
"Adverse Events 1:",
" Total: 0/10 (0.00%)"
] | {
"Adverse Events": [
"Adverse Events 1:",
" Total: 0/1699 (0.00%)",
"Adverse Events 2:",
" Total: 0/2004 (0.00%)"
],
"Eligibility": [
"Inclusion Criteria:",
" Adults 18 - 75 Years old",
" English or Spanish speaking",
" Recent visit to a participating primary care practice",
... | [
"Adverse Events 1:",
" Total: 0/1699 (0.00%)",
"Adverse Events 2:",
" Total: 0/2004 (0.00%)"
] | [
"Numerical_Comp"
] |
4988cb16-7dbb-4847-84e0-4a7957b32c72 | Comparison | Eligibility | NCT01256567 | NCT00429182 | a patient that has received an organ transplant within the last month, and is still bedridden would be excluded from the primary trial but may be eligible for the secondary trial | Contradiction | [
13,
28
] | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23
] | {
"Adverse Events": [
"Adverse Events 1:",
" Total: 7/7 (100.00%)",
" Febrile neutropenia 3/7 (42.86%)",
" Cardiac failure 1/7 (14.29%)",
" Neutrophil count decreased 1/7 (14.29%)",
" Muscular weakness 1/7 (14.29%)",
" Epistaxis 1/7 (14.29%)",
" Interstitial lung disease 1/7 (14... | [
"Inclusion Criteria:",
" The participant is Japanese",
" The participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1",
" The participant has a histopathologically or cytologically confirmed diagnosis of breast adenocarcinoma that is now metastatic or locally-recurrent and ... | {
"Adverse Events": [
"Adverse Events 1:",
" Total: 2/32 (6.25%)",
" Thrombocytopenia 1/32 (3.13%)",
" Death 1/32 (3.13%)"
],
"Eligibility": [
"Inclusion Criteria:",
" 18 to 55 years old",
" Metastatic breast carcinoma.",
" Histological confirmation of invasive breast carcino... | [
"Inclusion Criteria:",
" 18 to 55 years old",
" Metastatic breast carcinoma.",
" Histological confirmation of invasive breast carcinoma",
" Complete or partial response to pre-transplant standard-dose chemotherapy, or hormonal therapy. For bone disease, stable disease (SD) is allowed.",
" Patient mus... | [
"Clinical"
] |
e244fc3a-53b3-4158-99c5-a45afc726af6 | Comparison | Eligibility | NCT01205503 | NCT01286168 | Any patients with Documented allergy to cephalosporin or trimethoprim/sulfamethoxazole will not be eligible for the secondary trial and documented allergy to levofloxacin or celecoxib will also result in exclusion from the primary trial. | Contradiction | [
24
] | [
9
] | {
"Adverse Events": [
"Adverse Events 1:",
" Total: 1/32 (3.13%)",
" Non-cardiac chest pain *1/32 (3.13%)",
" MRSA positive infection in toe *0/32 (0.00%)",
" Lung Infection *0/32 (0.00%)",
" Blood bilirubin increased *0/32 (0.00%)",
" White blood cell decreased *0/32 (0.00%)",
"... | [
"Inclusion Criteria:",
" Participants must have histologically or cytologically confirmed breast cancer or non-hodgkin lymphoma and independent of protocol eligibility be determined to require one of the chemotherapy regimens listed below",
" Participants must require as standard-of-care treatment a chemother... | {
"Adverse Events": [
"Adverse Events 1:",
" Total: 0/104 (0.00%)"
],
"Eligibility": [
"Inclusion Criteria:",
" Females or males age 18-90 able to give informed consent",
" Undergoing bilateral mastectomy with immediate expander reconstruction or immediate implant reconstruction",
" Ma... | [
"Inclusion Criteria:",
" Females or males age 18-90 able to give informed consent",
" Undergoing bilateral mastectomy with immediate expander reconstruction or immediate implant reconstruction",
" May have either malignant or benign breast condition",
"Exclusion Criteria:",
" Antibiotic use in the fou... | [
"Clinical",
"Paraphrase"
] |
56530063-b408-47f2-8421-6be825f5559c | Single | Intervention | NCT00104650 | null | The Interventions in the primary trial are administered through different routes. | Entailment | [
0,
1,
2,
3,
4,
5
] | null | {
"Adverse Events": [
"Adverse Events 1:",
" Total: 19/35 (54.29%)",
" Anaemia 4/35 (11.43%)",
" Bone marrow failure 1/35 (2.86%)",
" Coagulopathy 0/35 (0.00%)",
" Leukopenia 2/35 (5.71%)",
" Neutropenia 2/35 (5.71%)",
" Thrombocytopenia 2/35 (5.71%)",
" Cardio-respiratory ... | [
"INTERVENTION 1: ",
" Bisphosphonate IV Q4W",
" Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)",
"INTERVENTION 2: ",
" Denosumab 180 mg Q12W",
" Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)"
] | null | null | [
"Clinical"
] |
d3379655-55b7-4e58-88c2-c3cd3e8cb557 | Comparison | Eligibility | NCT01783444 | NCT03346161 | Women with Newly diagnosed stage IV breast cancer, confirmed as ER+ Considering a mastectomy are eligible for the primary trial and the secondary trial | Contradiction | [
0,
1,
2,
3
] | [
0,
1,
2,
3,
4,
5,
6,
7
] | {
"Adverse Events": [
"Adverse Events 1:",
" Total: 37/104 (35.58%)",
" Anaemia 1/104 (0.96%)",
" Febrile neutropenia 0/104 (0.00%)",
" Leukopenia 0/104 (0.00%)",
" Neutropenia 0/104 (0.00%)",
" Pancytopenia 0/104 (0.00%)",
" Thrombocytopenia 0/104 (0.00%)",
" Atrial fibril... | [
"Key Inclusion Criteria:",
" - Women with locally advanced, recurrent, or metastatic breast cancer along with confirmation of estrogen-receptor positive (ER+). Measurable disease defined as at least one lesion 10 mm by CT or MRI that can be accurately measured in at least one dimension (CT scan slice thickness ... | {
"Adverse Events": [
"Adverse Events 1:",
" Total: 0/60 (0.00%)",
"Adverse Events 2:",
" Total: 0/60 (0.00%)"
],
"Eligibility": [
"Newly diagnosed or recurrent breast cancer",
" Considering a referral or already referred to a plastic surgeon by their surgical oncologist for possible re... | [
"Newly diagnosed or recurrent breast cancer",
" Considering a referral or already referred to a plastic surgeon by their surgical oncologist for possible reconstruction",
" Considering or completing a mastectomy.",
" Does not have known distant metastatic disease (stage IV disease) at the time of recruitme... | [
"Clinical"
] |
7bf988b4-5e6f-41c4-bef6-7b3549dd58d9 | Comparison | Eligibility | NCT00321464 | NCT01963481 | Patients with histologically confirmed stage 4 breast adenocarcinoma that is either ER positive, PR positive, or HER2/neu negative are eligible for both the secondary trial and the primary trial. | Contradiction | [
0,
1,
2,
3,
4,
5,
6,
7,
8
] | [
1,
2,
3,
4
] | {
"Adverse Events": [
"Adverse Events 1:",
" Total: 471/1013 (46.50%)",
" Anaemia 32/1013 (3.16%)",
" Bone marrow failure 0/1013 (0.00%)",
" Coagulopathy 0/1013 (0.00%)",
" Disseminated intravascular coagulation 2/1013 (0.20%)",
" Febrile neutropenia 22/1013 (2.17%)",
" Haemolyt... | [
"Inclusion Criteria:",
" Adults with histologically or cytologically confirmed breast adenocarcinoma",
" radiographic evidence of at least one bone mets",
" Easter Cooperative Oncology Group status of 0, 1 or 2;",
" adequate organ function",
"Exclusion Criteria:",
" Current or prior IV bisphosphona... | {
"Adverse Events": [
"Adverse Events 1:",
" Total: 10/23 (43.48%)",
" pulmonary embolism 10/23 (43.48%)"
],
"Eligibility": [
"Inclusion Criteria:",
" Patients must have histologically confirmed breast cancer that is ER positive and/or PR positive, and HER2/neu negative and have disease th... | [
"Inclusion Criteria:",
" Patients must have histologically confirmed breast cancer that is ER positive and/or PR positive, and HER2/neu negative and have disease that is metastatic (stage IV)",
" HER2/neu negative disease determined using commercially available/approved assay in local institutional or referen... | [
"Paraphrase"
] |
84915e35-a8c9-4d26-ad09-4b1df48a6df8 | Comparison | Results | NCT00956813 | NCT00320541 | the secondary trial and the primary trial results contain completely different outcome measures | Entailment | [
0,
1,
2,
3,
4,
5
] | [
0,
1,
2,
3
] | {
"Adverse Events": [
"Adverse Events 1:",
" Total: 0/101 (0.00%)",
"Adverse Events 2:",
" Total: "
],
"Eligibility": [
"Bothersome hot flashes, defined by their occurrence 28 times per week and of sufficient severity to make the patient desire therapeutic intervention",
" Presence of ... | [
"Outcome Measurement: ",
" To Evaluate the Efficacy of Flaxseed on Hot Flash Scores in Women as Measured by a Daily Prospective Hot Flash Diary.",
" The intra-patient difference in hot flash activity between baseline (study week 1) and treatment termination (study week 7) is the primary endpoint. The hot flas... | {
"Adverse Events": [
"Adverse Events 1:",
" Total: 27/94 (28.72%)",
" Anaemia 2/94 (2.13%)",
" Febrile neutropenia 2/94 (2.13%)",
" Leukopenia 1/94 (1.06%)",
" Neutropenia 0/94 (0.00%)",
" Thrombocytopenia 1/94 (1.06%)",
" Arrhythmia 0/94 (0.00%)",
" Atrial fibrillation 0/... | [
"Outcome Measurement: ",
" Overall Response Rate (ORR)",
" Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% i... | [
"Common sense",
"Clinical"
] |
64df451c-f868-49e6-9b4e-a325e62ce837 | Single | Intervention | NCT00365365 | null | the primary trial participants do not receive any vaccines | Entailment | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10
] | null | {
"Adverse Events": [
"Adverse Events 1:",
" Total: 23/78 (29.49%)",
" Febrile neutropenia * 4/78 (5.13%)",
" Neutropenia * 1/78 (1.28%)",
" Thrombocytopenia * 0/78 (0.00%)",
" Acute coronary syndrome * 1/78 (1.28%)",
" Cardiac failure congestive * 1/78 (1.28%)",
" Myocardial in... | [
"INTERVENTION 1: ",
" Stratum 1 (AC->T + Bevacizumab)",
" HER2-negative participants administered",
" doxorubicin and cyclophosphamide (AC) + bevacizumab for 4 cycles followed by",
" docetaxel (T) + bevacizumab for 4 cycles followed by",
" bevacizumab maintenance therapy for total of 52 weeks from da... | null | null | [
"Existence"
] |
dc4765a3-6168-4594-969b-3ce5ea7dc02a | Single | Intervention | NCT00753415 | null | Cohort A and B of the primary trial are administered the same Three electroporation injections of LD V934 | Contradiction | [
0,
1,
2,
3,
4,
5
] | null | {
"Adverse Events": [
"Adverse Events 1:",
" Total: 1/3 (33.33%)",
" Pericardial effusion 0/3 (0.00%)",
" Coronary artery stenosis 1/3 (33.33%)",
" Upper gastrointestinal haemorrhage 0/3 (0.00%)",
" Cellulitis 0/3 (0.00%)",
" Lobar pneumonia 0/3 (0.00%)",
" Pneumonia 1/3 (33.33%... | [
"INTERVENTION 1: ",
" Part A: V935 LD",
" Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.",
"INTERVENTION 2: ",
" Part A: V934 LD(3)+V935 LD",
" Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. ... | null | null | [
"Clinical"
] |
9c2ca035-d531-4d44-876e-6ed9f2d3f76b | Comparison | Results | NCT02038218 | NCT02187783 | the secondary trial and the primary trial use different units of measure in their results. | Entailment | [
11
] | [
9
] | {
"Adverse Events": [
"Adverse Events 1:",
" Total: 0/22 (0.00%)",
"Adverse Events 2:",
" Total: "
],
"Eligibility": [
"Inclusion Criteria:",
" Patients must have histological proof of a cancer - melanoma, breast, or lung cancer - which has spread to the CNS or glioblastoma (GBM) or oth... | [
"Outcome Measurement: ",
" Tumor Diameter",
" Tumor Diameter from patient scans",
" Time frame: Until remission or off treatment due to progression",
"Results 1: ",
" Arm/Group Title: DM-CHOC-PEN - Arm 1",
" Arm/Group Description: Cohort 1: Patients without liver involvement or history of liver dis... | {
"Adverse Events": [
"Adverse Events 1:",
" Total: 40/106 (37.74%)",
" Anaemia 1/106 (0.94%)",
" Febrile neutropenia 1/106 (0.94%)",
" Thrombocytopenia 1/106 (0.94%)",
" Atrial fibrillation 1/106 (0.94%)",
" Cardio-respiratory arrest 1/106 (0.94%)",
" Palpitations 1/106 (0.94%)... | [
"Outcome Measurement: ",
" Number of Participants With Solid Tumor Response 16 Weeks for Based Upon Local Investigator Assessments",
" Clinical benefit (CB) for patients with solid tumors were assessed using RECIST 1.1 and included responses of Complete Response (CR) or Partial Response (PR) or Stable Diseas... | [
"Clinical"
] |
7238ddd4-eade-4b88-8933-0c3df5be9875 | Comparison | Results | NCT00756496 | NCT00825682 | There were no significant differences in the results from the groups in the primary trial, and the Reflexology Group and control group in the secondary trial produced identical results. | Contradiction | [
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17
] | [
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20
] | {
"Adverse Events": [
"Adverse Events 1:",
" Total: 0/442 (0.00%)",
"Adverse Events 2:",
" "
],
"Eligibility": [
"Inclusion Criteria:",
" Female",
" > 40 years",
"Exclusion Criteria:",
" Pregnant women, or women who may become pregnant",
" Mammographic evidence of br... | [
"Outcome Measurement: ",
" Area Under the Receiver Operating Characteristic (ROC) Curve to Compare Diagnostic Accuracy of 2 Algorithms in Breast Cancer Diagnosis",
" The primary objective of this study was to demonstrate non-inferiority of the Siemens' processing algorithm to Lorad's processing algorithm with... | {
"Adverse Events": [
"Adverse Events 1:",
" Total: 0/47 (0.00%)",
"Adverse Events 2:",
" Total: 0/25 (0.00%)"
],
"Eligibility": [
"Inclusion Criteria:",
" Breast cancer adult patients scheduled to receive adjuvant radiation therapy",
"Exclusion Criteria:",
" Open wounds or evi... | [
"Outcome Measurement: ",
" The Lee Fatigue Scale",
" The Lee Fatigue Scale consists of 18 items related to fatigue and energy: 13 items in the fatigue subscale and 5 items in the energy subscale. The mean of the 13 items in the fatigue subscale (range from 0-10) and the mean of the 5 items in the energy subsc... | [
"Numerical_Comp",
"Common sense"
] |
aeddc485-09b1-4ddc-9a45-3a8bf0bec2c3 | Single | Results | NCT02988986 | null | Over 6 weeks of TAK-228 Plus Tamoxifen treatment patients in the primary trial experienced a 5% reduction in the Percentage of cells with Ki67 expression | Entailment | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13
] | null | {
"Adverse Events": [
"Adverse Events 1:",
" Total: 1/28 (3.57%)",
" hyperglycemia 1/28 (3.57%)"
],
"Eligibility": [
"Inclusion Criteria:",
" Female or male 18 years of age.",
" Newly diagnosed ER-positive, HER2-negative breast cancer. ER-positive is defined as 1% immunohistochemica... | [
"Outcome Measurement: ",
" Ki67 Expression",
" Ki67 expression change from baseline to 6 weeks",
" Time frame: Baseline to 6 weeks",
"Results 1: ",
" Arm/Group Title: TAK-228 Plus Tamoxifen",
" Arm/Group Description: TAK-228 will be orally administered at 30 mg weekly for 16 weeks.",
" Tamoxifen... | null | null | [
"Numerical_Op",
"Paraphrase"
] |
204d5293-d6e5-452a-8961-3b76d6be35c9 | Comparison | Results | NCT01766102 | NCT01664091 | Arm 2 of the primary trial had higher Operative Time than Arm 1, therefore Intra-operative Mammography performed better than the Standard Mammography in this regard. In the secondary trial there is no control group against which we can compare. | Entailment | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19
] | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9
] | {
"Adverse Events": [
"Adverse Events 1:",
" Total: 0/0",
"Adverse Events 2:",
" Total: 0/0"
],
"Eligibility": [
"Inclusion Criteria:",
" Newly diagnosed with a breast abnormality undergoing an excisional biopsy with wire localization or newly diagnosed with invasive breast cancer or du... | [
"Outcome Measurement: ",
" Comparison of Operative Time Savings",
" To compare the overall operative time savings using intra-operative digital mammography compared with standard specimen mammography.",
" Time frame: At the time of the procedure (approximately 1 week after randomization)",
"Results 1: ",... | {
"Adverse Events": [
"Adverse Events 1:",
" Total: 4/31 (12.90%)",
" Infection 1/31 (3.23%)",
" Deflation 1/31 (3.23%)",
" Asymmetry 1/31 (3.23%)",
" Delayed Healing Wound 1/31 (3.23%)"
],
"Eligibility": [
"Inclusion Criteria:",
" Patients must have newly diagnosed, clin... | [
"Outcome Measurement: ",
" Success Rate",
" Success rate was defined as the percentage of participants experiencing all of the following: 1) completion of PMRT and placement of the permanent implant and/or flap reconstruction; 2) no major complications (infection requiring hospitalization, major revisions, ea... | [
"Numerical_Comp",
"Common sense"
] |
4ed1c5fd-58e5-4fe8-97b1-59ed509ccb10 | Single | Adverse Events | NCT01702571 | null | there are several different instances of cardiac related AE recorded for cohort 1 of the primary trial | Entailment | [
8,
9,
10,
11
] | null | {
"Adverse Events": [
"Adverse Events 1:",
" Total: 427/2002 (21.33%)",
" ANAEMIA 13/2002 (0.65%)",
" BONE MARROW FAILURE 1/2002 (0.05%)",
" DISSEMINATED INTRAVASCULAR COAGULATION 1/2002 (0.05%)",
" FEBRILE NEUTROPENIA 1/2002 (0.05%)",
" THROMBOCYTOPENIA 11/2002 (0.55%)",
" ACUT... | [
"Adverse Events 1:",
" Total: 427/2002 (21.33%)",
" ANAEMIA 13/2002 (0.65%)",
" BONE MARROW FAILURE 1/2002 (0.05%)",
" DISSEMINATED INTRAVASCULAR COAGULATION 1/2002 (0.05%)",
" FEBRILE NEUTROPENIA 1/2002 (0.05%)",
" THROMBOCYTOPENIA 11/2002 (0.55%)",
" ACUTE CORONARY SYNDROME 3/2002 (0.15%)",
... | null | null | [
"Numerical_Op",
"Clinical"
] |
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