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36
Comparison
Intervention
NCT01928186
NCT00684983
All the primary trial participants do not receive any oral capecitabine, oral lapatinib ditosylate or cixutumumab IV, in conrast all the secondary trial subjects receive these.
Contradiction
[ "INTERVENTION 1: ", " Diagnostic (FLT PET)", " Patients with early stage, ER positive primary breast cancer undergo FLT PET scan at baseline and 1-6 weeks after the start of standard endocrine treatment. The surgery follows 1-7 days after the second FLT PET scan.", " Tracer used in the FLT PET (positron em...
[ "INTERVENTION 1: ", " Arm A", " Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO", "INTERVE...
5bc844fc-e852-4270-bfaf-36ea9eface3d
Single
Eligibility
NCT00662129
null
Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
Contradiction
[ "DISEASE CHARACTERISTICS:", " Histologically or cytologically confirmed infiltrating breast cancer", " Clinical evidence of metastatic disease", " Measurable disease, defined as at least one measurable lesion per RECIST criteria", " No non-measurable disease only, defined as all other lesions, including...
null
86b7cb3d-6186-4a04-9aa6-b174ab764eed
Comparison
Adverse Events
NCT00093145
NCT00703326
Heart-related adverse events were recorded in both the primary trial and the secondary trial.
Entailment
[ "Adverse Events 1:", " Total: 5/32 (15.63%)", " Febrile neutropenia 1/32 (3.13%)", " Supraventricular tachycardia 1/32 (3.13%)", " Hypersensitivity 2/32 (6.25%)", " Catheter site infection 1/32 (3.13%)", " Confusional state 1/32 (3.13%)" ]
[ "Adverse Events 1:", " Total: 285/752 (37.90%)", " Anaemia 2/752 (0.27%)", " Disseminated intravascular coagulation 2/752 (0.27%)", " Febrile neutropenia 51/752 (6.78%)", " Neutropenia 47/752 (6.25%)", " Thrombocytopenia 2/752 (0.27%)", " Atrial fibrillation 1/752 (0.13%)", " Atrial flutter ...
dbed5471-c2fc-45b5-b26f-430c9fa37a37
Single
Eligibility
NCT01097642
null
Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial.
Contradiction
[ "Inclusion Criteria:", " Patients with histologic confirmation of invasive breast carcinoma.", " Patients must have intact primary tumor.", " Patients greater than or equal to 18 years.", " Patients should have T1N1-3M0 or T2-4 N0-3M0.", " Patients with bilateral breast cancer are eligible.", " Pa...
null
20c35c89-8d23-4be3-b603-ac0ee0f3b4de
Comparison
Intervention
NCT00852930
NCT02308020
Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy.
Contradiction
[ "INTERVENTION 1: ", " Laser Therapy Alone", " therapist administered laser treatment", " laser: therapist administered laser", "INTERVENTION 2: ", " Mld Alone", " therapist administered manual lymphatic drainage", " manual lymphatic drainage: therapist administered massage therapy" ]
[ "INTERVENTION 1: ", " Part A Abemaciclib: HR+, HER2+ Breast Cancer", " Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET). Participants with hormone receptor positive HR+, HER2+ breast ...
f17cb242-419d-4f5d-bfa4-41494ed5ac0e
Comparison
Eligibility
NCT00971945
NCT01027416
Patients must have already participated in a specific clinical study to participate in the primary trial or the secondary trial.
Contradiction
[ "Inclusion Criteria:", " Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criter...
[ "Inclusion Criteria:", " The patient must consent to be in the study and must have signed an approved consent form conforming to institutional guidelines", " The patient must be 18 years or older.", " Core biopsy should definitively demonstrate invasive carcinoma.", " Invasive carcinoma should be ER-aph...
fc5c4554-7ce9-4c16-b374-a3cd9d15b021
Single
Eligibility
NCT00633750
null
Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial.
Contradiction
[ "Inclusion Criteria:", " Clinical stage I or II (T1 or T2, N0 or N1) invasive mammary carcinoma", " Diagnosis may be made by fine needle aspiration cytology or core biopsy", " A repeat core biopsy is not required for patients who have a paraffin embedded diagnostic core biopsy specimen available for immuno...
null
96b77cdd-aa9f-4770-8447-8a04d9ca5da7
Comparison
Intervention
NCT00003404
NCT00711529
the primary trial and the secondary trial have Hypnotherapy based interventions, the secondary trial also used pain medication in its intervention.
Contradiction
[ "INTERVENTION 1: ", " Adjuvant Radiotherapy", " Adjuvant radiation was started within 12 weeks of local excision or breast re-excision.", " Adjuvant Radiotherapy: Adjuvant radiation therapy" ]
[ "INTERVENTION 1: ", " Hypnotherapy", " Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.", "INT...
c73faed2-371b-4238-bf7d-293fae380203
Single
Eligibility
NCT00201773
null
Adele is an 85 year old woman with Stage II histologically confirmed ER+ breast cancer with an ECOG of 0, she is eligible for the primary trial
Entailment
[ "Inclusion Criteria:", " Must be female with histologically confirmed breast cancer", " Stage II-IV disease", " ER and/or PR positive", " ECOG Performance Status 0-1", " Tumor must be present following core needle biopsy as determined by physical exam or radiographic evaluation.", " Postmenopausal...
null
8765009d-ffc4-4395-ab7a-11ecdfd43a40
Comparison
Intervention
NCT02606708
NCT02504424
Only patients in the primary trial receive 40.5 Gy of brachytherapy, patients in the secondary trial receive no radiotherapy whatsoever.
Contradiction
[ "INTERVENTION 1: ", " Accelerated Intensity Modulated Radiation Therapy (AIMRT)", " All patients shall receive a total of 40.5 Gy to the entire breast in 2.7 Gy/fraction x 15 fractions, Monday to Friday for 3 weeks delivered prone in uniform daily doses through IMRT tangent fields. A concurrent boost to the o...
[ "INTERVENTION 1: ", " AeroForm Tissue Expander", " AeroForm Tissue Expansion inflation with carbon dioxide by remote control", " AeroForm Tissue Expander: The AeroForm Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon...
0ad7293d-df35-42e8-881d-f2afc3f7d3fd
Single
Eligibility
NCT00895414
null
Certain drinks are banned for patients undertaking the primary trial.
Entailment
[ "Inclusion Criteria:", " Tissue diagnosis of a breast carcinoma", " The oncologist must have prescribed doxorubicin as part of the planned chemotherapy regimen", " Have acceptable organ function within 14 days of enrollment defined as:", " liver function: total bilirubin, AST and ALT within normal insti...
null
2bc1e094-41a1-46d9-9b0c-b5a47f23323d
Single
Adverse Events
NCT00777049
null
Most of the cases of CHF in the primary trial, were in cohort 1.
Entailment
[ "Adverse Events 1:", " Total: 12/32 (37.50%)", " Anaemia 0/32 (0.00%)", " Neutropenia 1/32 (3.13%)", " Thrombocytopenia 4/32 (12.50%)", " Atrial fibrillation 1/32 (3.13%)", " Cardiac failure congestive 1/32 (3.13%)", " Myocardial ischaemia 1/32 (3.13%)", " Abdominal discomfort 0/32 (0.00%)",...
null
83b83400-1439-462d-bba3-42817b5b1fa1
Single
Eligibility
NCT00058058
null
Candidates for the primary trial must have a life expectancy over 6 months.
Contradiction
[ "DISEASE CHARACTERISTICS:", " Recently confirmed unilateral ductal carcinoma in situ or invasive cancer of the breast", " Confirmed by biopsy or fine needle aspiration (FNA) within the past 60 days", " Negative or benign mammogram (BI-RADS assessment 1 or 2) and negative or benign clinical breast exam of t...
null
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f
Single
Eligibility
NCT02964234
null
Patients eligible for the primary trial must live in the USA.
Entailment
[ "Inclusion Criteria:", " Age 52-75 years old;", " Identification as Latina/Hispanic/Chicana female;", " Residence in Pilsen, Little Village, East Side or South Chicago;", " No history of health volunteerism;", " No history of breast cancer; and", " Lack of a mammogram within the last two years", ...
null
17a821f8-5e68-4bf7-ac01-3f96ddfc5187
Comparison
Intervention
NCT02525718
NCT02606708
Patients in group 1 of the secondary trial and the primary trial do not receive the same dosage of AIMRT.
Entailment
[ "INTERVENTION 1: ", " Placebo", " Subjects will be randomly selected to receive saline (placebo), administered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery.", " Saline: If randomized to this arm, subjects will receive an intraoperative injection of saline. (...
[ "INTERVENTION 1: ", " Accelerated Intensity Modulated Radiation Therapy (AIMRT)", " All patients shall receive a total of 40.5 Gy to the entire breast in 2.7 Gy/fraction x 15 fractions, Monday to Friday for 3 weeks delivered prone in uniform daily doses through IMRT tangent fields. A concurrent boost to the o...
d76d6c7f-ba39-483c-a89e-152af5ae2878
Comparison
Intervention
NCT01669343
NCT00146172
the primary trial administers letrozole for 28 days, whereas the secondary trial administers is intervention over 4 cycles of 21 days.
Contradiction
[ "INTERVENTION 1: ", " Post-menopausal Women Using Adjuvant Letrozole", " Part A Routine Care Letrozole; Part B Double Dose Letrozole in overweight/obese participants", " Letrozole: Part A Monitor standard of care letrozole use for 28 days; measure blood levels of estrogens and vitamin D at start and end of...
[ "INTERVENTION 1: ", " Neratinib 40 mg", "Neratinb 40 mg qd", "INTERVENTION 2: ", " Neratinib 80 mg", "Neratinib 80 mg qd" ]
65f3e755-3e23-4e84-a218-87922759094d
Single
Eligibility
NCT00952692
null
Candidates for the primary trial must have adequate colon and liver function, and must not be currently receiving amiodarone or have received amiodarone in the last 28 day. Renal function is not relevant for inclusion.
Contradiction
[ "Inclusion Criteria:", " The following criteria are to be checked at the time of study entry. The patients may only be included in the study if ALL of the following statements are FULLFILLED:", " The patient (male or female) is at least 18 years old at the time of signature of the informed consent form.", "...
null
d3590771-806b-4754-a455-38113bfedfca
Comparison
Intervention
NCT00994279
NCT00545077
both the primary trial and the secondary trial administer Bevacizumab to every single HER2+ patient.
Contradiction
[ "INTERVENTION 1: ", " Arm 1: Yoga Intervention", " Yoga Intervention", " Yoga: Yoga sessions", "INTERVENTION 2: ", " Arm 2: Educational Wellness Group", " Educational Wellness Group", " Education: Educational Wellness Group" ]
[ "INTERVENTION 1: ", " Arm A: Endocrine Therapy (ET)", " Endocrine treatment consisting of either letrozole or fulvestrant. Patients will be randomized to receive bevacizumab 15mg/kg every 3 weeks plus endocrine treatment or endocrine treatment as a single agent. The patients will receive the assigned treatmen...
941b960f-8d57-4830-9d4c-8e96765ba76c
Comparison
Intervention
NCT01425268
NCT01373671
CO2 is utilised as part of the intervention in a single one of the study groups in the primary trial, and not used in either of the study groups in the secondary trial.
Entailment
[ "INTERVENTION 1: ", " AeroForm Tissue Expansion", " AeroForm Tissue Expansion inflation with carbon dioxide by remote control", " AeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release ...
[ "INTERVENTION 1: ", " FFDM and DBT", " FFDM exam and DBT scan on Siemens MAMMOMAT Inspiration", "INTERVENTION 2: ", " FFDM Only", "FFDM exam only" ]
f79a9011-0a68-4255-a40f-5d73af412bf0
Comparison
Adverse Events
NCT00777101
NCT00559845
There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial.
Entailment
[ "Adverse Events 1:", " Total: 31/116 (26.72%)", " Neutropenia 1/116 (0.86%)", " Thrombocytopenia 1/116 (0.86%)", " Acute myocardial infarction 1/116 (0.86%)", " Myocardial infarction 0/116 (0.00%)", " Pericardial effusion 0/116 (0.00%)", " Abdominal pain 3/116 (2.59%)", " Ascites 1/116 (0.86...
[ "Adverse Events 1:", " Total: 8/54 (14.81%)", " Anaemia 1/54 (1.85%)", " Febrile Neutropenia 1/54 (1.85%)", " Retinopathy Hypertensive 1/54 (1.85%)", " Febrile Infection 1/54 (1.85%)", " Postoperative Wound Complication 1/54 (1.85%)", " Cardiac Imaging Procedure Abnormal 1/54 (1.85%)", " Mal...
1b4f8828-cc7f-4831-a1c0-cc14e6ad23af
Comparison
Intervention
NCT00075270
NCT01781299
the primary trial is testing a chemotherapy treatment whereas the secondary trial is testing a physcotherapy course.
Contradiction
[ "INTERVENTION 1: ", " Lapatinib With Paclitaxel", " Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage ...
[ "INTERVENTION 1: ", " AlloDerm RTU", " Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement.", "AlloDerm RTU", "INTERVENTION 2: ", " SurgiMend PRS", " Participants within this arm will have the acellular dermal matrix Surg...
57f3a264-9119-4931-9f9c-9cb20e945973
Single
Results
NCT00305448
null
At least 4 patients in both cohorts of the primary trial achieved either complete response (CR) or partial response (PR).
Entailment
[ "Outcome Measurement: ", " Objective Response Rate (ORR)", " An objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR). A patient has best overall response of CR if she had overall response of CR or PR on one visit and met the c...
null
589e2f5b-9286-465b-8162-bb1549cd5ece
Single
Adverse Events
NCT03066947
null
Less than 1/4 patients in the primary trial experienced adverse events.
Contradiction
[ "Adverse Events 1:", " Total: 8/24 (33.33%)", " Restrictive Cardiomyopathy * 21/24 (4.17%)", " Palpitations * 21/24 (4.17%)", " GERD * 21/24 (4.17%)", " Fever * 21/24 (4.17%)", " Sepsis * 1/24 (4.17%)", " Urinary Tract Infection * 21/24 (4.17%)", " Influenza A * 21/24 (4.17%)", " Dehydrat...
null
8275f846-59b6-404d-a6d8-e01335279f1a
Single
Intervention
NCT01390064
null
The both Cohorts of the primary trial receive their treatment via Subcutaneous administration.
Entailment
[ "INTERVENTION 1: ", " Initial Cohort", " Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration 5 doses of 300 micrograms", " Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine vi...
null
b3c1f5d1-6f7f-4bab-a4e8-5d1dab597cc7
Single
Eligibility
NCT01142661
null
the primary trial does not accept patients with grade 1 alopecia.
Entailment
[ "Inclusion Criteria", " In order to receive eribulin under this protocol, the subjects oncologist must have documented experience treating subjects with eribulin in a prior clinical study. Subjects who meet all of the following criteria will be included in the treatment protocol:", " Recurrent, locally advanc...
null
18d9991c-ca96-4bab-93af-77654857a07f
Comparison
Intervention
NCT01925170
NCT00324259
Participant in cohort 1 of the primary trial undergo a Mammography, whereas patients in cohort 1 of the secondary trial receive 6 mg Estradiol as supplementation for the Mammography.
Contradiction
[ "INTERVENTION 1: ", " Mammography Only", " For this reporting arm, the interpretation and analysis was done with mammography only.", "INTERVENTION 2: ", " Mammography With Adjunct MBI", " For this reporting arm, the interpretation and analysis was done with both mammography and MBI together." ]
[ "INTERVENTION 1: ", " Arm 1 (6 mg Estradiol)", " 6 mg of estradiol daily (2 mg tid).", "INTERVENTION 2: ", " Arm 2 (30 mg Estradiol)", " 30 mg of estradiol. (10 mg tid)" ]
6fb9056d-277c-4dc2-9b45-d7661bb41831
Single
Adverse Events
NCT00129376
null
A single patient in the primary trial experienced a clinically significant inflammation of the back of the throat.
Entailment
[ "Adverse Events 1:", " Total: 12/63 (19.05%)", " Febrile neutropenia * [1]4/63 (6.35%)", " Congestive heart failure * [2]1/63 (1.59%)", " Cardiac-ischemia/infarction * 1/63 (1.59%)", " Vomiting * [1]1/63 (1.59%)", " Acute Pharyngitis * 1/63 (1.59%)", " Infection * 3/63 (4.76%)", " Neutrop...
null
52b23601-2276-4634-96c7-8b6e55596085
Single
Results
NCT00431067
null
More than 5% of the primary trial participants achieved partial response (PR).
Contradiction
[ "Outcome Measurement: ", " Objective Response (OR)", " Objective response (OR) including complete response (CR) and partial response (PR) according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria .", " Time frame: From first dose of study medication to response measurement, up to 34 ...
null
95e05332-4926-4381-90a4-87941269e7bf
Comparison
Intervention
NCT00054028
NCT02162719
Both the primary trial and the secondary trial at least partly administer their interventions orally.
Contradiction
[ "INTERVENTION 1: ", " Suramin and Paclitaxel", " Suramin will be infused weekly over 30 minutes. Four hours after the completion of the suramin infusion the 1 hour infusion of paclitaxel will begin." ]
[ "INTERVENTION 1: ", " Ipatasertib and Paclitaxel", " Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from t...
20d51467-b059-4f39-b636-d32f2dc692da
Single
Adverse Events
NCT01427933
null
Neutropenia affected the majority of patients in cohort 1 of the primary trial.
Contradiction
[ "Adverse Events 1:", " Total: 26/69 (37.68%)", " Anaemia 2/69 (2.90%)", " Febrile neutropenia 3/69 (4.35%)", " Neutropenia 4/69 (5.80%)", " Cardiac arrest 1/69 (1.45%)", " Cardiac failure congestive 1/69 (1.45%)", " Cardiac tamponade 1/69 (1.45%)", " Pericardial effusion 1/69 (1.45%)", " ...
null
15c83d26-f9ba-44cc-a920-6941781cdd8b
Comparison
Results
NCT01648322
NCT00436566
the primary trial has a shorter time frame than the secondary trial, both of these studies employ the same units of measure in their evaluation.
Contradiction
[ "Outcome Measurement: ", " Duration of Moderate Neurtopenia Post First Chemotherapy Administration", " Number of days In which the patient has had an absolute neutrophil count (ANC) Level < 2.0 x 10^9/L after first cycle of chemotherapy", " Time frame: The first of 4, 21 Day Chemotherapy Cycles", "Result...
[ "Outcome Measurement: ", " Number of Patients With Congestive Heart Failure (CHF) While on Active Treatment", " [Not Specified]", " Time frame: 6 months", "Results 1: ", " Arm/Group Title: AC/PTL", " Arm/Group Description: Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel...
e100212f-5bef-4f84-a3c1-d18a6b3e8355
Single
Intervention
NCT02286843
null
the primary trial is testing a novel radiotracer called 89Zr-trastuzumab to evaluate its use for visualization of HER2+ lesions.
Entailment
[ "INTERVENTION 1: ", " HER2-targeted PET/CT", " Pts with confirmed HER2- breast cancer will undergo HER2-targeted PET/CT. 89Zr-trastuzumab is a novel radiotracer which allows excellent visualization of HER2+ lesions. 89Zr-pertuzumab is a novel radiotracer which may allow for specific visualization of HER2+ les...
null
56d2a387-49dd-49b9-93bb-bcb092bf2714
Single
Intervention
NCT00300781
null
Participants of the primary trial are assigned an intervention depending on their prior treatments.
Entailment
[ "INTERVENTION 1: ", " Neratinib 240, Prior Trastuzumab", " Neratinib: 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen in participants with prior trastuzumab treatment.", "INTERVENTION 2: ", " Neratinib 240, No Prior Tr...
null
2485a3e1-7520-47d2-b941-32ebf91e5b65
Comparison
Eligibility
NCT00899574
NCT01007942
the primary trial and the secondary trial use different inclusion criteria for their cohorts, so patients may be eligible for one cohort, but not the other.
Contradiction
[ "Inclusion Criteria:", " Patients with biopsy-confirmed breast cancer (prior histological documentation is acceptable).", " Patients with measurable skin metastases (chest wall recurrence and/or non-chest wall skin metastases are eligible).", " Skin metastases not suitable for or patient refusing definitiv...
[ "Inclusion Criteria:", " Histologically or cytologically confirmed invasive breast carcinoma with locally recurrent or radiological evidence of metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent.", " HER2+ status defined as IHC 3+ staining or in situ hybridiza...
b97d9465-db14-43af-9451-4b824e67abb8
Single
Eligibility
NCT02010021
null
A patient has recently been receiving Tamoxifen to treat breast cancer, they are excluded from the primary trial.
Entailment
[ "Inclusion Criteria:", " Histologic Documentation of invasive breast cancer by core needle or incisional biopsy. Excess baseline biopsy tumor tissue sufficient to make three 5-micron sections must be available for molecular analyses as part of this study.", " The invasive cancer must be estrogen receptor alph...
null
798c0983-5265-47ea-bfcd-735738793482
Comparison
Intervention
NCT02176083
NCT03061175
Neither the primary trial or NCT0306117 use chemotherapy or radiotherapy in their intervention.
Entailment
[ "INTERVENTION 1: ", " Intervention", " Text message management prompts: YBCS will receive text message prompts on how to manage hot flashes and vaginal dryness", " Text message management prompts", "INTERVENTION 2: ", " Control", " Control YBCS will not receive text message prompts on managing hot ...
[ "INTERVENTION 1: ", " Arm I (Web-Based CPM-DA)", " Patients receive a website address, a secure username and password, and instructions for using the web-based CPM-DA.", " Internet-Based Intervention: Receive web-based CPM-DA", " Survey Administration: Ancillary studies", "INTERVENTION 2: ", " Arm ...
127e9179-6781-4b9a-abe9-080d2ffad591
Comparison
Eligibility
NCT00089479
NCT02964234
Agatha had her 50th birthday last week, she has a histologically confirmed adenocarcinoma of the breast, with no evidence of metastatic disease. She is eligible for the primary trial but not the secondary trial.
Entailment
[ "Inclusion Criteria:", " female patients 18-70 years of age;", " adenocarcinoma of the breast;", " previous invasive breast cancer if diagnosed >5 years before entering study;", " no evidence of metastatic disease.", "Exclusion Criteria:", " history of severe hypersensitivity reaction to Taxotere;"...
[ "Inclusion Criteria:", " Age 52-75 years old;", " Identification as Latina/Hispanic/Chicana female;", " Residence in Pilsen, Little Village, East Side or South Chicago;", " No history of health volunteerism;", " No history of breast cancer; and", " Lack of a mammogram within the last two years", ...
a54e1dfa-3975-4dc6-8530-c0adc79b1b0d
Single
Results
NCT01401166
null
several patients in cohort 1 of the primary trial Preferred oral tablets as a Method of Drug Administration.
Contradiction
[ "Outcome Measurement: ", " Percentage of Participants by Preferred Method of Drug Administration", " The preferred method of drug administration (IV or SC Herceptin) was assessed in trial-specific telephone interviews with each study participant. Participants were asked, \"All things considered, which method ...
null
16dc5a77-5758-4d19-9801-6e9932d9fbc9
Comparison
Adverse Events
NCT00190671
NCT00455533
In the primary trial cohort 2 had more patients with Leukopenia than cohort 1, whereas in the secondary trial cohort 1 had more than cohort 2. Cohort 1 of the primary trial had the highest proportion of patients with leukopenia.
Contradiction
[ "Adverse Events 1:", " Total: 6", " Agranulocytosis 0/42 (0.00%)", " Anaemia 2/42 (4.76%)", " Febrile neutropenia 1/42 (2.38%)", " Leukopenia 0/42 (0.00%)", " Neutropenia 1/42 (2.38%)", " Thrombocytopenia 1/42 (2.38%)", " Cardio-respiratory arrest 0/42 (0.00%)", " Pericardial effusion 1/4...
[ "Adverse Events 1:", " Total: 17/145 (11.72%)", " ANAEMIA 0/145 (0.00%)", " LEUKOPENIA 2/145 (1.38%)", " NEUTROPENIA 1/145 (0.69%)", " LEUKOCYTOSIS 1/145 (0.69%)", " THROMBOCYTOPENIA 1/145 (0.69%)", " FEBRILE NEUTROPENIA 1/145 (0.69%)", " THROMBOTIC THROMBOCYTOPENIC PURPURA 0/145 (0.00%)", ...
2ed770a0-fe98-4029-9511-ad04a94a1a69
Single
Adverse Events
NCT00863655
null
There were 7 more cases of Anaemia and 1 more case of Disseminated intravascular coagulation in cohort 1 of the primary trial compared to cohort 2.
Contradiction
[ "Adverse Events 1:", " Total: 158/482 (32.78%)", " Anaemia 7/482 (1.45%)", " Disseminated intravascular coagulation 1/482 (0.21%)", " Lymphadenopathy 0/482 (0.00%)", " Neutropenia 0/482 (0.00%)", " Thrombocytopenia 2/482 (0.41%)", " Anaemia 28/482 (1.66%)", " Disseminated intravascular coagu...
null
b4c97206-66fd-468b-8388-fac076222c10
Single
Eligibility
NCT00450723
null
There are several types of surgical and therapeutic treatments which are banned for patients wanting to take part in the primary trial.
Entailment
[ "DISEASE CHARACTERISTICS:", " Histologically confirmed breast cancer", " Stage I or II disease (T1-T2, N0, M0/MX disease)", " No chest wall invasion by tumor (T3 disease)", " Medially or centrally located lesion", " No multicentric disease", " Multifocal disease allowed", " No clinically positi...
null
6e22d118-af77-41bd-bd47-9385779f33aa
Single
Results
NCT01945775
null
The shortest PFS in the Talazoparib group of the primary trial was over a month shorter than the Median PFS for that group.
Entailment
[ "Outcome Measurement: ", " Progression-Free Survival (PFS): Independent Radiological Facility (IRF) Assessment", " IRF assessed PFS was defined as time (in months) from randomization until the date of first documented radiologic progressive disease per response evaluation criteria in solid tumors (RECIST) ver...
null
ccc5362a-33d0-4f1b-be46-d31729ba9194
Single
Intervention
NCT03765996
null
Participants in group 2 of the primary trial receive taping to anastomosis regions., but no Complex Decongestive Physiotherapy.
Contradiction
[ "INTERVENTION 1: ", " Decongestive Physiotherapy", " This group received Complex Decongestive Physiotherapy.", " Decongestive Physiotherapy: This group received CDP, which include MLD, short-stretch bandages, lymph-reducing exercises, and skin care. MLD was applied to the anterior trunk, posterior trunk, a...
null
fa530b28-9142-49f2-aa80-4d04fa532910
Single
Adverse Events
NCT00063570
null
None of the patients in cohort 1 of the primary trial had a platlet deficiency, and none of the patients in cohort 2 had Pyrexia.
Contradiction
[ "Adverse Events 1:", " Total: 17", " Anaemia 2/52 (3.85%)", " Febrile neutropenia 4/52 (7.69%)", " Pancytopenia 1/52 (1.92%)", " Thrombocytopenia 0/52 (0.00%)", " Abdominal pain 1/52 (1.92%)", " Constipation 1/52 (1.92%)", " Pyrexia 2/52 (3.85%)", " Hepatic failure 1/52 (1.92%)", " Hyp...
null
7cbe445f-2df6-4a87-be6b-7ecc1e80b08b
Comparison
Adverse Events
NCT00503906
NCT01142661
The adverse events in the primary trial where all equally prevalent, whereas in the secondary trial, alcohol poisoning was reported as the most common event.
Contradiction
[ "Adverse Events 1:", " Total: 8/29 (27.59%)", " Leukopenia [1]1/29 (3.45%)", " Thrombocytopenia [1]1/29 (3.45%)", " Abscess [1]1/29 (3.45%)", " Breast Abscess 1/29 (3.45%)", " Fever/Sepsis [1]1/29 (3.45%)", " Neutropenic Fever [2]1/29 (3.45%)", " Peripheral Neuropathy [1]1/29 (3.45%)",...
[ "Adverse Events 1:", " Total: 7/9 (77.78%)", " Febrile Neutropenia1/9 (11.11%)", " Neutropenia1/9 (11.11%)", " Tachycardia1/9 (11.11%)", " Hematemesis1/9 (11.11%)", " Small Bowel Obstruction1/9 (11.11%)", " Pneumonia1/9 (11.11%)", " Hypokalemia1/9 (11.11%)", " Alcohol Poisoning1/9 (11.11%...
41cf791e-ed7a-48e5-af84-eefc9fa41ba7
Single
Adverse Events
NCT00894504
null
There were only 3 adverse events in the primary trial which occurred more than twice.
Contradiction
[ "Adverse Events 1:", " Total: 10/71 (14.08%)", " ATRIAL FIBRILLATION 1/71 (1.41%)", " CARDIAC TAMPONADE 1/71 (1.41%)", " PERICARDIAL EFFUSION 1/71 (1.41%)", " SUPRAVENTRICULAR TACHYCARDIA 1/71 (1.41%)", " DIARRHOEA 1/71 (1.41%)", " NAUSEA 1/71 (1.41%)", " VOMITING 1/71 (1.41%)", " CHEST P...
null
d417aa7b-6d2c-46f8-812c-426ea60e0328
Single
Results
NCT00171704
null
Most patients in the Letrozole group of the primary trial had a decreased Bone Mineral Density of the Lumbar Spine after 24 months.
Entailment
[ "Outcome Measurement: ", " Percent Change From Baseline of Bone Mineral Density of the Lumbar Spine (L2-l4)", " Lumbar spine (L2-L4) BMD measurements by dual energy X-ray absorptiometry (DXA) were performed after surgery and within 2 weeks prior to randomization and repeated every 6 months for the first 2 yea...
null
2744cc0a-86e9-4764-ae1c-f10f635dc283
Single
Intervention
NCT02392611
null
In the primary trial cohort 1 patients must have failed or be intolerant to standard therapy, or have no standard therapy available, and cohort 2 patients must respond well to standard therapy.
Contradiction
[ "INTERVENTION 1: ", " Monotherapy: Alobresib 0.6 mg", " Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 0.6 mg orally once daily on Study Day 1 through C1D28 of 28 days ...
null
2e4717fd-b349-48a3-b751-88674dfaaa18
Comparison
Eligibility
NCT01237327
NCT00030823
the primary trial and the secondary trial do not have any overlapping inclusion criteria, apart from the mimimum age limit of 18.
Contradiction
[ "Inclusion Criteria:", " Previous participation in study 971-ONC-0028-080.", "Exclusion Criteria:", " Subjects who had not previously participated in study 971-ONC-0028-080." ]
[ "DISEASE CHARACTERISTICS:", " Diagnosis of breast cancer at high risk for recurrence, defined by one of the following:", " Stage IV that is free of all known disease after eradication by surgery, radiotherapy, or chemotherapy", " May or may not have elevated CA 15-3 or CEA levels", " Stage I, II, or III...
b0c65cd7-8cad-404d-8704-ee074e480f57
Single
Adverse Events
NCT00509769
null
1 patient in the primary trial had toxic hepatitis.
Entailment
[ "Adverse Events 1:", " Total: 30/112 (26.79%)", " Thrombocytopenia 1/112 (0.89%)", " Dysphagia 1/112 (0.89%)", " Haemorrhoidal haemorrhage 1/112 (0.89%)", " Oesophageal stenosis 1/112 (0.89%)", " Upper gastrointestinal haemorrhage 1/112 (0.89%)", " Asthenia 1/112 (0.89%)", " Disease progress...
null
28e20650-e100-4e30-a319-5eceb69a979d
Comparison
Results
NCT02336737
NCT01432886
the secondary trial is testing for the DLT of its interventions, whereas the primary trial is evaluating the efficacy of lymph node detection through the use of SentiMag and SiennaXP.
Entailment
[ "Outcome Measurement: ", " Number of Participants With Detected Lymph Nodes", " The proportion of lymph nodes detected intraoperatively by SentiMag and SiennaXP in relation the proportion of lymph nodes detected by the combination of Technetium Sulfur Colloid and Isosulfan blue dye", " Time frame: During s...
[ "Outcome Measurement: ", " Number of Participants With Dose Limiting Toxicity (DLT)", " For DLT evaluation, severity (grade) was classified according to common terminology criteria for adverse events version 4.0 (CTCAE v4.0). DLTs were defined as grade 4 neutropenia persisting for more than 7 days; grade 3 or...
8cf0c320-9486-4531-9212-bb3284b734f1
Single
Eligibility
NCT00317603
null
Participants of the primary trial must be older than 18, have histologically confirmed stage 4 breast cancer, ECOG<2 and a life expectancy exceeding 6 months.
Entailment
[ "Inclusion Criteria:", " Histologically confirmed Stage IV breast cancer", " Prior banked malignant effusion or significant malignant effusion for tumor harvest or surgically-accessible tumor nodule of at least 2cm in greatest diameter by physical exam, magnetic resonance imaging (MRI) or computed tomography ...
null
34a75478-e7cc-495e-86c3-d0accdaf1ddd
Comparison
Intervention
NCT00332709
NCT00659373
All the primary trial participants receive the same dose of Letrozole, and all patients in the secondary trial are administered the same dose of Tamoxifen.
Contradiction
[ "INTERVENTION 1: ", " Letrozole", " Letrozole 2.5 mg/day for 3 years", "INTERVENTION 2: ", " Letrozole + Zoledronic Acid", " Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months" ]
[ "INTERVENTION 1: ", " Tamoxifen", " Tamoxifen 20mg orally daily for 5 years", "INTERVENTION 2: ", " Ovarian Function Suppression", " Tamoxifen 20mg orally daily or Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 d...
47780450-1202-4934-8e50-b29416b124f5
Single
Adverse Events
NCT00179309
null
There were 2 cases of severe back pain observed in the primary trial.
Contradiction
[ "Adverse Events 1:", " Total: 3/25 (12.00%)", " Anemia 0/25 (0.00%)", " Sinus tachycardia 0/25 (0.00%)", " Pericardial effusion 1/25 (4.00%)", " Gastrointestinal disorders - Other, specify -stomatitis) 0/25 (0.00%)", " Vomiting 1/25 (4.00%)", " Fever 0/25 (0.00%)", " Injection site reaction ...
null
27421e64-e9f0-42a9-8070-bdfb0ce4ce7c
Comparison
Adverse Events
NCT01856543
NCT00365599
Across all cohorts of the secondary trial and the primary trial there was only a single recorded case of Myocarditis and Thrombosis.
Contradiction
[ "Adverse Events 1:", " Total: 3/73 (4.11%)", " Chest Pain - cardiac 1/73 (1.37%)", " Myocarditis 1/73 (1.37%)", " Pericarditis 1/73 (1.37%)", " Ventricular tachycardia 1/73 (1.37%)", " Skin infection 0/73 (0.00%)", " Dermatitis radiation 0/73 (0.00%)", " Dyspnea 1/73 (1.37%)", "Adve...
[ "Adverse Events 1:", " Total: 4/43 (9.30%)", " Hemoglobin [1]1/43 (2.33%)", " Hemorrhage/Bleeding [2]1/43 (2.33%)", " Neutrophils/granulocytes (ANC/AGC) [3]1/43 (2.33%)", " Platelets [4]1/43 (2.33%)", " Anorexia [5]1/43 (2.33%)", " Sodium, serum-low (hyponatremia) [1]1/43 (2.33%)", " T...
c5e6497a-2e2f-4663-97fd-e73ba8904b0c
Single
Intervention
NCT01105650
null
Participants in cohort 1 of the primary trial weighing less than 45 kg receive 5 million units/m^2 less of IL-2, than participants over 45 kg, but all participants will be administered Methylprednisolone 3 times per week for 6 doses.
Contradiction
[ "INTERVENTION 1: ", " Arm 1: CsA", " Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).", " Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.", "Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 thro...
null
c4dd814d-f525-465f-abe1-a7975771d57e
Single
Adverse Events
NCT00924352
null
One patient in the primary trial had abnormally low red blood cells, white blood cells, and platelets.
Entailment
[ "Adverse Events 1:", " Total: 11/56 (19.64%)", " Febrile Neutropenia * 3/56 (5.36%)", " Neutropenia * 1/56 (1.79%)", " Pancytopenia * 1/56 (1.79%)", " Atrial Fibrillation * 1/56 (1.79%)", " Coronary Artery Disease * 1/56 (1.79%)", " Constipation * 1/56 (1.79%)", " Chest Pain * 1/56 (1.79%)",...
null
cfd93077-87c5-458b-8712-e1896929309d
Comparison
Adverse Events
NCT00503906
NCT01142661
The adverse events in the primary trial where all equally prevalent, whereas in the secondary trial, progression of disease was reported as the most common event.
Entailment
[ "Adverse Events 1:", " Total: 8/29 (27.59%)", " Leukopenia [1]1/29 (3.45%)", " Thrombocytopenia [1]1/29 (3.45%)", " Abscess [1]1/29 (3.45%)", " Breast Abscess 1/29 (3.45%)", " Fever/Sepsis [1]1/29 (3.45%)", " Neutropenic Fever [2]1/29 (3.45%)", " Peripheral Neuropathy [1]1/29 (3.45%)",...
[ "Adverse Events 1:", " Total: 7/9 (77.78%)", " Febrile Neutropenia1/9 (11.11%)", " Neutropenia1/9 (11.11%)", " Tachycardia1/9 (11.11%)", " Hematemesis1/9 (11.11%)", " Small Bowel Obstruction1/9 (11.11%)", " Pneumonia1/9 (11.11%)", " Hypokalemia1/9 (11.11%)", " Alcohol Poisoning1/9 (11.11%...
a3faaf85-62c6-430f-acf2-9c5992ee5221
Comparison
Adverse Events
NCT01931163
NCT00274469
Less than 5% of cohort 1 of the primary trial had High blood sugar, 0% of the secondary trial patients were recorded as having High blood sugar.
Entailment
[ "Adverse Events 1:", " Total: 6/22 (27.27%)", " Thrombocytopenia 1/22 (4.55%)", " leucocytopenia 1/22 (4.55%)", " neutropenia 1/22 (4.55%)", " papilledema 1/22 (4.55%)", " Nausea 1/22 (4.55%)", " hyperglycemia 1/22 (4.55%)" ]
[ "Adverse Events 1:", " Total: 24/101 (23.76%)", " LYMPHADENOPATHY 0/101 (0.00%)", " FEBRILE NEUTROPENIA 20/101 (0.00%)", " ATRIAL FIBRILLATION 1/101 (0.99%)", " ARRHYTHMIA 20/101 (0.00%)", " CARDIAC FAILURE 22/101 (1.98%)", " CARDIAC FAILURE CONGESTIVE 20/101 (0.00%)", " CORONARY OSTIAL STEN...
65e3afbb-70f6-4e1a-89e6-d819f8b95ab6
Comparison
Intervention
NCT00574145
NCT03167359
Radiotherapy and healing touch therapy is used in all cohorts of the primary trial and the secondary trial.
Contradiction
[ "INTERVENTION 1: ", " Radiotherapy/Supportive Care (A)", " Patients receive radiotherapy and healing touch therapy from a healing-touch therapist once a week for the duration of their radiotherapy", "INTERVENTION 2: ", " Control ARM (B)", " Patients receive radiotherapy and sham healing touch therapy ...
[ "INTERVENTION 1: ", " Participants With Stage 0-III Breast Cancer", " Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks.", " Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participa...
335936e4-9eaa-43b3-84fe-6f112c0d0226
Single
Results
NCT02622074
null
There was 38% more patients with DLT in cohort 2 of the primary trial than in cohort 1.
Contradiction
[ "Outcome Measurement: ", " Number of Participants With Dose Limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.0 (NCI CTCAE v4.0)", " The following events, if considered to be study-treatment-related by the Investigator, were considered a DL...
null
19921113-538e-4fd2-81a6-6053f2dd6459
Single
Adverse Events
NCT00448279
null
In total there were 5x more adverse events in cohort 1 of the primary trial, than in cohort 2.
Contradiction
[ "Adverse Events 1:", " Total: 4/26 (15.38%)", " Febrile neutropenia * 1/26 (3.85%)", " Gastric volvulus * 20/26 (0.00%)", " General Malaise * 21/26 (3.85%)", " Hospitalisation for intrapleuric chemotherapy and thoracentesis * 21/26 (3.85%)", " Acute renal failure * 21/26 (3.85%)", "Adverse Event...
null
6a013bb4-0688-4f02-96c5-062f3ca67ae1
Comparison
Results
NCT01106040
NCT01441596
the primary trial and the secondary trial are not studying PFS, PBR or DLTs.
Contradiction
[ "Outcome Measurement: ", " Concordance of Blue Dye and Lymphoseek", " The proportion of lymph nodes detected intraoperatively by blue dye that were also detected by Lymphoseek.", " Time frame: Surgery after injections of Lymphoseek and blue dye", "Results 1: ", " Arm/Group Title: Intent-To-Treat", "...
[ "Outcome Measurement: ", " Patient Benefit Rate at 12 Weeks", " Percentage of patients with patient benefit at week 12. Patient benefit was defined by the absence of central nervous system (CNS) disease progression according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 in addition to ...
c103a786-0b1d-4124-aa5d-4945ded2c384
Comparison
Eligibility
NCT00274768
NCT00654836
Patients with at most stage 3 cancer are eligible for the secondary trial and the primary trial.
Contradiction
[ "DISEASE CHARACTERISTICS:", " Histologically or cytologically confirmed diagnosis of adenocarcinoma of the breast", " Evidence of metastatic involvement (stage IV disease)", " Patients must have measurable disease", " At least one measurable lesion as defined by the Response Evaluation Criteria in Solid...
[ "DISEASE CHARACTERISTICS:", " Histologically or cytologically confirmed primary adenocarcinoma of the breast", " Locally recurrent or metastatic disease", " Must have HER-2-negative breast cancer or, if HER-2-positive, must be unable to receive trastuzumab (Herceptin®) or have previously received trastuzum...
2746a75c-7f01-4dc3-a05e-5c7499e75555
Single
Eligibility
NCT00416572
null
Patients with a prior malignancy of skin cancer are excluded from the primary trial.
Contradiction
[ "INCLUSION CRITERIA (Disease Characteristics):", " Diagnosis of breast cancer", " Stage I or II disease", " No more than 10 positive lymph nodes", " First-time diagnosis", " Under the age of 50 at diagnosis", " Finished active treatment within the past 2 months", " English-speaking only", " ...
null
df64a4c5-08f3-40c7-a4e7-2a6271bc9e53
Single
Adverse Events
NCT00193037
null
None of the patients in Cohort 1 of the primary trial suffered from Hypotension.
Entailment
[ "Adverse Events 1:", " Total: 18/50 (36.00%)", " Hypotension 0/50 (0.00%)", " Bradycardia 0/50 (0.00%)", " Cardiac Arrest 1/50 (2.00%)", " Diarrhea 2/50 (4.00%)", " Pain - Abdominal 1/50 (2.00%)", " Hemorrhage - GI 1/50 (2.00%)", " Vomiting 0/50 (0.00%)", " Nausea 0/50 (0.00%)", " Dehy...
null
682f5e80-75c4-4a36-9bc1-b389a98ad160
Comparison
Eligibility
NCT02673918
NCT01042938
Only White and Asian patients are eligible for both the primary trial and the secondary trial.
Contradiction
[ "Inclusion Criteria:", " Diagnosis of breast cancer", " Part 1 only: Surgery for breast cancer within the past eight weeks (mastectomy or lumpectomy with either sentinel or axillar dissection), including those women with a history of previous surgery for breast cancer, radiation therapy or chemotherapy", " ...
[ "Inclusion Criteria:", " Female with a diagnosis of, non-inflammatory breast adenocarcinoma and be referred for post-operative radiotherapy without concurrent chemotherapy.", " Participants must be at least 21 years of age.", " Participants must not be pregnant.", " Participants can be from any racial o...
7028841e-28e6-4fd3-a27c-2ae2e7dc7b52
Single
Adverse Events
NCT00934856
null
In total, across both cohorts of the primary trial, there were at least 2 patients with a fever.
Entailment
[ "Adverse Events 1:", " Total: 2/6 (33.33%)", " Febrile neutropenia * 1/6 (16.67%)", " Neutropenia * 0/6 (0.00%)", " Thrombocytopenia * 1/6 (16.67%)", " Diarrhoea * 0/6 (0.00%)", " Pyrexia * 0/6 (0.00%)", " Thrombosis in device * 1/6 (16.67%)", " Fatigue * 0/6 (0.00%)", " Mucosal inflammat...
null
348c9273-6aa1-43a8-840d-3cf080874669
Single
Results
NCT00068588
null
We cannot compare results between the two Arms of the primary trial as there were no patients in cohort 1.
Entailment
[ "Outcome Measurement: ", " Maximum Tolerated Dose Determined by Dose-limiting Toxicities", " 1st 3 pts will be treated on arm 2. If 0/3 DLTs observed, the dose will be escalated to arm 3. If 1/3 DLTs onserved on arm 2, 3 more pts will be treated on arm 2. If no additional DLTs are observed on arm 2, the dose ...
null
dfe6228e-6bfb-49d3-b0b4-397aab177bea
Single
Results
NCT01302379
null
Only one patient cohort of the primary trial had a positive median Insulin change from baseline.
Contradiction
[ "Outcome Measurement: ", " Insulin", " Insulin measured as percent change from baseline", " Time frame: change from baseline to 6 months", "Results 1: ", " Arm/Group Title: Metformin + Lifestyle Intervention", " Arm/Group Description: Metformin: Week 1: 500 mg at dinner time Weeks 2-4: 1000 mg at d...
null
9f424ebb-63b8-4930-b2c1-cd46fff4d706
Single
Results
NCT00324259
null
Cohort 2 of the primary trial had one more patient with Stable disease than cohort 1.
Entailment
[ "Outcome Measurement: ", " Clinical Benefit Rate (CR Plus PR Plus SD)", " Complete response (CR) + partial response (PR) + stable disease (SD) using RECIST 1.0", " CR = disappearance of all target lesions", " PR = at least a 30% decrease in the sum of the longest diameter of target lesions taking as ref...
null
c1f8c7fb-22de-4501-af86-d9eb59542ae3
Single
Eligibility
NCT00331630
null
Left ventricular ejection fraction > 50% is required for participation in the primary trial.
Entailment
[ "DISEASE CHARACTERISTICS:", " Histologically confirmed breast cancer", " Clinical stage I-III disease", " Measurable disease defined as 1 unidimensionally measurable lesion 20 mm by conventional techniques OR 10 mm with spiral CT scan", " HER2/neu 3+ by immunohistochemistry or positive by fluorescent...
null
6630047b-7ebc-4435-8203-cf6bbe6b6ee7
Comparison
Eligibility
NCT00903162
NCT01674062
Patients with cancer in situ of the cervix are eligible for the primary trial and the secondary trial.
Entailment
[ "Inclusion Criteria:", " Women 18 years of age or older", " History of invasive ER+ or PR+ breast cancer treated with at least 4.5 years of tamoxifen", " No current evidence of recurrent invasive disease or metastatic disease. Patients may have a history of bilateral breast cancer", " Premenopausal (est...
[ "Inclusion Criteria:", " Females greater than or equal to ( ) 18 years of age, with histologically-confirmed HER2-positive breast cancer", " Metastatic breast cancer, with progression on trastuzumab-based therapy as last treatment for metastatic disease", " Less than or equal to ( ) 3 chemotherapy regime...
039c3fc2-f798-4d97-b904-9aa7d363eeef
Single
Eligibility
NCT00121134
null
the primary trial requires participants to have undergone PTR.
Entailment
[ "Inclusion Criteria:", " Histologically or cytologically confirmed invasive breast cancer, preoperative stages II-III per AJCC 6th edition, based on baseline evaluation by clinical examination and/or breast imaging", " Patients must have completed preoperative (neoadjuvant) chemotherapy with a standard chemot...
null
50a2a4a9-2b30-4901-b7bc-9c77b8ca870f
Comparison
Intervention
NCT00537771
NCT00354640
participants of cohort 1 in the primary trial and all participants of the secondary trial take 1 milligram of anastrozole and 40 milligrams of simvastatin PO QD.
Contradiction
[ "INTERVENTION 1: ", " Arimidex Group", " Anastrozole(ARIMIDEX): 1 mg once daily oral dose", "INTERVENTION 2: ", " TAM Group", " Tamoxifen : 20 mg once daily oral dose" ]
[ "INTERVENTION 1: ", " Anastrozole and Simvastatin", " adjuvant therapy : laboratory analysis", " pharmacological study : laboratory analysis", " simvastatin : 40 milligram tablet PO QD for 14 days", " anastrozole : 1 milligram tablet PO QD for 14 days" ]
f8028143-35d1-4cc3-895a-acb577db4715
Single
Eligibility
NCT00193180
null
A female patient over the age of 18 suffering from chronic viral hepatitis would be eligible for the primary trial.
Contradiction
[ "Inclusion Criteria:", " To be included in this study, you must meet the following criteria:", " Metastatic breast cancer confirmed by biopsy", " No more than one prior chemotherapy regimen for metastatic breast cancer", " Able to perform activities of daily living with minimal assistance", " Adequat...
null
907f7e56-b6ec-4a43-bf3a-14f93c644bc1
Single
Eligibility
NCT00853996
null
Women classified as high-risk of developing breast cancer within the next 5 years and within her lifetime by the Gail model are eligible for the primary trial.
Entailment
[ "Inclusion Criteria:", " Gail risk >= 1.7% and/or relative risk >= 3 times that for 5-year age group", " Premenopausal", " More than 6 months since initiating or discontinuing oral contraceptives", " At increased risk for breast cancer, as indicated by >= 1 of the following risk factors:", " BRCA1/2 ...
null
3fa58451-21ba-4ad9-8d13-6a9eefa17a5b
Single
Adverse Events
NCT01572727
null
Cohort 1 of the primary trial recorded more optical adversse events than cohort 2.
Contradiction
[ "Adverse Events 1:", " Total: 61/202 (30.20%)", " FEBRILE NEUTROPENIA 1/202 (0.50%)", " LEUKOPENIA 0/202 (0.00%)", " NEUTROPENIA 2/202 (0.99%)", " CARDIAC FAILURE CONGESTIVE 0/202 (0.00%)", " CARDIO-RESPIRATORY ARREST 1/202 (0.50%)", " PERICARDIAL EFFUSION 1/202 (0.50%)", " CATARACT 1/202 (0...
null
a41bf7b0-9a09-4ce0-8832-f13758581f20
Single
Adverse Events
NCT00130533
null
Less than 0.25% of patients in cohort 1 of the primary trial suffered from Hyperbilirrubinemia.
Entailment
[ "Adverse Events 1:", " Total: 23/436 (5.28%)", " Neutropenia G 3; Leucopenia G2 1/436 (0.23%)", " Hyperbilirrubinemia [1]1/436 (0.23%)", " Supraventricular arrhythmia NOS [2]1/436 (0.23%)", " Heart failure [2]0/436 (0.00%)", " Infarction and cardiac arrest 0/436 (0.00%)", " Ischemia cardiac/...
null
5f2d2015-eaf9-45a8-9583-fddbc9807287
Comparison
Eligibility
NCT03273426
NCT01091168
Patients with dementia or schizophrenia may be eligible for the primary trial and the secondary trial.
Contradiction
[ "Inclusion Criteria:", " Patients", " with unilateral primary cancer pathologically confirmed before neoadjuvant chemotherapy (NAC)", " who received NAC", " with detectable lesion / clip marker on ultrasound", " with cT1-T3 tumors", " clinical and imaging complete or near-complete response on MRI"...
[ "Inclusion Criteria:(main conditions)", " Female patients 18 to 75 years of age with metastatic breast cancer histologically/cytologically confirmed not amenable to curative surgery or radiotherapy and who have received at least two prior chemotherapy regimens including anthracyclines,taxanes,antimetabolite and ...
609ddd08-ebd5-4661-be43-874b65dbfe52
Comparison
Eligibility
NCT00322348
NCT00429572
the primary trial and the secondary trial use ECOG to evaluate potential candidates' performance status.
Contradiction
[ "Inclusion Criteria:", " Pre-menopausal women aged 18 years or over with histologically/cytologically-confirmed oestrogen receptor positive (ER +ve) breast cancer", " World Health Organization (WHO) performance status of 0, 1, or 2", " Provided written informed consent", "Exclusion Criteria:", " Treat...
[ "Inclusion Criteria:", " Recurrent or residual metastatic breast carcinoma", " Zubrod performance status less than 2", " 18-60 years old", " Related donor human leukocyte antigen (HLA)-compatible for allogeneic transplantation or unrelated HLA-compatible donor.", " No major organ dysfunction or activ...
b6ac985d-87ae-4e0f-83e1-38033c1db5cc
Single
Results
NCT00431067
null
More than 5% of the primary trial participants achieved Objective Response (OR).
Entailment
[ "Outcome Measurement: ", " Objective Response (OR)", " Objective response (OR) including complete response (CR) and partial response (PR) according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria .", " Time frame: From first dose of study medication to response measurement, up to 34 ...
null
43ff9425-5e6e-4a85-a8ca-0c0c67a96623
Single
Intervention
NCT00470301
null
Every patient in the primary trial is given tipifarnib PO, along with paclitaxel, doxorubicin hydrochloride and acyclophosphamide IV, but only a subset of participants undergo axillary lymph node dissection.
Contradiction
[ "INTERVENTION 1: ", " Arm I", " See Detailed Description", " tipifarnib: Given orally", " paclitaxel: Given IV", " doxorubicin hydrochloride: Given IV", " cyclophosphamide: Given IV", " pegfilgrastim: Given SC", " conventional surgery: surgical procedures performed on patients", " axillar...
null
b3ccde30-cdfc-4e18-aee0-8b3a921dde39
Comparison
Adverse Events
NCT00191815
NCT01301729
None of the patients in the primary trial or the secondary trial committed suicide.
Contradiction
[ "Adverse Events 1:", " Total: 6", " Atrial fibrillation 1/67 (1.49%)", " Ventricular fibrillation 1/67 (1.49%)", " Gastrointestinal perforation 1/67 (1.49%)", " Periproctitis 1/67 (1.49%)", " General physical health deterioration 1/67 (1.49%)", " Escherichia sepsis 1/67 (1.49%)", " Pneumonia...
[ "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%)" ]
8697a59e-0f1c-452a-b15a-6d24e2df387f
Single
Eligibility
NCT02721147
null
Stephanie has been living with her husband for 31 years, she is eligible for the primary trial.
Entailment
[ "Inclusion Criteria:", " Female", " Age > 21 years", " Has diagnosis of non-recurrent stage I-III breast cancer", " Completed active treatment (e.g., chemotherapy, radiation therapy, surgery) 6 months-5 years ago (current use of endocrine therapy is acceptable)", " Has a partner or spouse who is > 21...
null
4ab74186-5f4e-4139-af05-d4a9871a251d
Single
Adverse Events
NCT00432172
null
All of the adverse events recorded in the primary trial were cardiac related.
Contradiction
[ "Adverse Events 1:", " Total: 5/45 (11.11%)", " Neutrophils/granulocytes (ANC/AGC) * [1]0/45 (0.00%)", " Neutrophils/granulocytes (ANC/AGC) * [2]0/45 (0.00%)", " Diabetes decompensation * 0/45 (0.00%)", " Diarrhea * [2]0/45 (0.00%)", " Mucositis/stomatitis and Vomiting * [3]0/45 (0.00%)", " ...
null
082ee581-f420-4892-b098-ce82c6ad0210
Single
Eligibility
NCT00982319
null
Pre and Post menopausal women can enter the primary trial, as long as they do not have prior hormone replacement therapy.
Entailment
[ "Inclusion Criteria:", " Female 18 + years of age", " Confirmed diagnosis of DCIS on core or excisional/incisional biopsy and scheduled for definitive surgery", " Pre or Post menopausal women reporting no use of hormone replacement therapy, tamoxifen or raloxifene within the prior 6 months to eligibility s...
null
7bf084eb-873a-4011-9b98-3a899ee582ee
Comparison
Intervention
NCT01575522
NCT00181363
the primary trial and the secondary trial are testing completely different modalities of interventions, but utilising the same 21 day cycle.
Contradiction
[ "INTERVENTION 1: ", " Treatment (Tivantinib)", " Patients receive tivantinib PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant marke...
[ "INTERVENTION 1: ", " Prone", "Prone position", "INTERVENTION 2: ", " Supine", "Supine position" ]
ef0406b4-34ad-4cbd-83a4-dd0f118c4d5a
Single
Eligibility
NCT00741260
null
Patients with ERBB2 positive tumors are eligible for the primary trial.
Entailment
[ "INCLUSION CRITERIA", " PART 1:", " confirmed pathologic diagnosis of a solid tumor not curable with available therapies for which neratinib plus capecitabine is a reasonable treatment option.", " PART 2:", " confirmed histologically and/or cytologically confirmed diagnosis of breast cancer, metastatic ...
null
06bc9cff-e9fc-42c7-a2a3-c01a036e04c6
Single
Results
NCT01268150
null
Most patients in the primary trial treated with Eribulin Mesylate did not achieve complete response (CR) or partial response (PR).
Entailment
[ "Outcome Measurement: ", " Objective Response Rate (ORR)", " The ORR was defined as the percentage of participants with best overall response (BOR) of confirmed complete response (CR) or partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Targeted lesions were as...
null
f6c85ce8-e0fc-4186-a961-6207dd4cacd2
Single
Eligibility
NCT02321527
null
Patients with invasive breast cancer with a diameter of less than 4 cm are included in the primary trial.
Entailment
[ "Inclusion Criteria:", " 18 years or older.", " Ipsilateral biopsy-proven invasive breast cancer <5 cm in maximal dimension by Ultrasound or Mammography.", " No abnormal axillary nodes identified on grayscale AUS, or abnormal nodes with benign subsequent FNA biopsy.", "Exclusion Criteria:", " Pregnant...
null
5bdd61d9-aadf-4944-afe3-a04242d9c2b2
Single
Eligibility
NCT01252277
null
Fiona's sister, who is 34 years old was diagnosed with a ductal carcinoma, therefore fiona may be eligible for the primary trial.
Entailment
[ "Inclusion Criteria", " Subjects must be premenopausal and between the ages of 25 and 54 and must have had a menstrual period within the past 12 months. Women who are not menstruating regularly due to use of certain types of contraceptives may be entered with restrictions. Their estrogen progesterone, and follic...
null
b8ce7d6a-d707-48e0-816c-de7ac3a63823
Single
Adverse Events
NCT01498458
null
For some adverse event types in the primary trial, there were no recorded cases.
Contradiction
[ "Adverse Events 1:", " Total: 6/8 (75.00%)", " Thrombocytopenia 1/8 (12.50%)", " Hypertension 1/8 (12.50%)", " Hepatotoxicity 3/8 (37.50%)", " Pancreatectomy * 1/8 (12.50%)" ]
null
53d88010-e7d7-41c7-b20d-6328c8e507d1
Single
Adverse Events
NCT01416389
null
Cohort 1 of the primary trial had more cases of Hepatic encephalopathy and Pneumonia than cohort 2.
Contradiction
[ "Adverse Events 1:", " Total: 5/26 (19.23%)", " Febrile neutropenia 1/26 (3.85%)", " Abdominal pain 0/26 (0.00%)", " Constipation 0/26 (0.00%)", " Nausea 1/26 (3.85%)", " Pancreatitis 1/26 (3.85%)", " Vomiting 2/26 (7.69%)", " Pain 0/26 (0.00%)", " Pneumonia 0/26 (0.00%)", " Urinary tr...
null
8257bf5c-fae6-44c0-a86d-293746fdc468
Comparison
Eligibility
NCT00372424
NCT00041067
Patients with HER2 positive breast tumors are eligible for the primary trial, but excluded from the secondary trial.
Contradiction
[ "Inclusion Criteria:", " Breast cancer with evidence of unresectable, locally recurrent, or metastatic disease.", " Tumors over-expressing Her-2", " Candidate for treatment with docetaxel/trastuzumab", "Exclusion Criteria:", " Histology of inflammatory carcinoma", " AST and/or ALT >1.5 x ULN concom...
[ "DISEASE CHARACTERISTICS:", " Histologically confirmed stage IV breast cancer", " Metastasis to the ipsilateral supraclavicular lymph nodes allowed", " HER2-positive by fluorescence in situ hybridization (FISH) or immunohistochemistry 3+ staining confirmed in the adjuvant or metastatic setting", " No ef...
7ea00c54-b4a1-427b-8ef7-a8b3cb96e8c2
Comparison
Intervention
NCT03346161
NCT01000662
The intervention for the primary trial does not require patients to undergo any medical treatment during the study, whereas in the secondary trial, all patients receive Radiation Therapy.
Entailment
[ "INTERVENTION 1: ", " Arm 1: BREASTChoice (Decision Tool)", " Investigators recruited patients scheduled for a plastic/reconstruction consult. Investigators identified patients who completed a mastectomy, or were scheduled for one, and considering reconstruction, but didn't have an appointment with a plastic/...
[ "INTERVENTION 1: ", " ARM 1 Daily Boost", " Radiation Therapy", " Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). ...
974225b7-9089-499c-9550-0a7207fd28b2
Single
Eligibility
NCT01506609
null
Patients with cytologically confirmed breast cancer, who's Locally recurrent disease is amenable to radiation with curative intent are not eligible for the primary trial.
Entailment
[ "Inclusion Criteria:", " Histologically or cytologically confirmed breast cancer that is either locally recurrent or metastatic.", " Locally recurrent disease must not be amenable to surgical resection or radiation with curative intent.", " Must have a documented deleterious Breast Cancer Gene BRCA1 or BRC...
null
6f533f52-c8e4-4983-8968-69af03a9e34a
Single
Intervention
NCT00591864
null
the primary trial does not have an intervention section.
Entailment
[ "INTERVENTION 1: ", " Study Participants", " There are no arms or subgroups in this study." ]
null
690b8562-7d68-4642-bacb-601f227bb763
Single
Intervention
NCT03618017
null
the primary trial's intervention section does not describe the intervention dosage, frequency or duration for cohort 2, however cohort 1 recieves placebo twice daily for two months.
Contradiction
[ "INTERVENTION 1: ", " Recruitment Population", " Pre-randomization recruitment and enrollment" ]
null
75f94edd-dbde-4a19-be18-e67c767f6d8f
Comparison
Results
NCT00687440
NCT01307891
the primary trial had a higher percentage of patients with at least partial response than either cohort of the secondary trial.
Entailment
[ "Outcome Measurement: ", " Number of Participants Who Had a Tumor Response, According to Standard RECIST (Response Evaluation Criteria in Solid Tumors) Criteria", " Those who achieved either complete (disappearance of all target lesions) or partial (at least 30% decrease in the sum of the longest diameter (LD...
[ "Outcome Measurement: ", " Objective Response Rate", " Patient response rates will be measured by the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI. Responses include the following: Complete Response (CR) disappearance of all target lesions; Partial...
e37ed9ee-b312-4ea3-a6eb-3785fa94ccc4
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SemEval 2024 Task 2: Safe Biomedical Natural Language Inference for Clinical Trials

Dataset Details

Dataset Description

Compiled dataset for SemEval 2024 Task 2: Safe Biomedical Natural Language Inference for Clinical Trials.

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