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Both cohorts the primary trial apply the topical intervention for approximately every 4-6 hours every day for a week of the study. | INTERVENTION 1:
Arm I (Curcumin-based Gel)
Patients apply curcumin-based gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.
Curcumin-based Gel: Applied topically
Laboratory Biomarker Analysis: Correlat... | Entailment |
the primary trial recorded half as many patients vomiting as the secondary trial. | Adverse Events 1:
Nausea 1/20 (5.00%)
Adverse Events 1:
Nausea/vomiting 4/39 (10.26%) | Contradiction |
Cohort 2 of the primary trial recieves Doxorubicin only during cycles 1-4, and then Doxorubicin, cyclophosphamide, Herceptin and docetaxel during Cycle 5 of the study. | INTERVENTION 2:
AC Followed by Docetaxel + Herceptin (AC→TH)
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. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly start... | Contradiction |
Only Chinese women with stage 4 or Unresectable, locally recurrent cancer breast cancer are eligible for the primary trial. | Inclusion Criteria:
Female patients of Chinese origin with histologically or cytologically proven diagnosis of breast cancer.
Unresectable, locally recurrent breast cancer or stage IV disease. | Entailment |
Participants of cohort 1 in the primary trial received more Dasatinib and Paclitaxel than those in cohort 2. | INTERVENTION 1:
Phase I: Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2
Cohort 1: Eligible patients were enrolled and treated with 4-week cycles of trastuzumab 2 mg/kg IV weekly (following a loading dose of 4 mg/kg in cycle 1) and paclitaxel 80 mg/m2 weekly x 3 weeks followed by a rest period of 7 days. Das... | Contradiction |
the primary trial recorded 23 adverse events. | Adverse Events 1:
Total: 0/23 (0.00%) | Contradiction |
There were no adverse event in the primary trial which affected more than 10% of a particular patient cohort. | Adverse Events 1:
Febrile neutropenia 30/280 (10.71%) | Contradiction |
Patients with pure ductal carcinoma in situ (DCIS) or Melanoma are eligible for both the secondary trial and the primary trial, and are able to participate in these trials alongside other drug trials, up to a maximum of 3. | Inclusion Criteria:
The patient is currently not participating in another investigational drug study.
Patients with pure ductal carcinoma in situ (DCIS) or non-invasive carcinoma if lymph node biopsy is part of the surgical plan.
Inclusion Criteria:
Ductal or Infiltrating Ductal Carcinoma | Contradiction |
Patients must have histologically or cytologically confirmed PR+ invasive breast cancer, with Primary tumor > 2 cm in diameter TO PARTICIPATE in the primary trial. | Inclusion Criteria:
Patients must have histologically or cytologically confirmed primary invasive breast cancer
Primary tumor is larger than 2 cm in diameter (T2) as measured by caliper or ultrasound
Overexpression and/or amplification of HER2 is confirmed by immunohistochemistry (IHC) 3+ or fluorescence in situ ... | Contradiction |
There was 16.67% more cases of hemorrhaging in the primary trial than in the secondary trial. | Adverse Events 1:
Total: 7/15 (46.67%)
Cardiac arrest * 1/15 (6.67%)
Chest pain - cardiac * 1/15 (6.67%)
Diarrhea * 1/15 (6.67%)
Duodenal hemorrhage * 1/15 (6.67%)
Fatigue * 1/15 (6.67%)
Fever * 1/15 (6.67%)
Sudden death NOS * 1/15 (6.67%)
Sepsis * 1/15 (6.67%)
Skin infection * 1/15 (6.67%)
Neutro... | Contradiction |
In the primary trial, Dasatinib, 70 mg, Twice Daily results in a better median PFS than Dasatinib, 100 mg, Daily. The opposite was true in the secondary trial. | Outcome Measurement:
Progression-free Survival
RECIST progression defined as 20% increase in the sum of longest diameters of target measurable lesions over the smallest sum observed, unequivocal progression of non-measurable disease, the appearance of any new lesion/site, death due to disease without prior documen... | Contradiction |
Between both of the patient cohorst of the primary trial and the secondary trial there was only a single patient who suffered heart failure. | Adverse Events 1:
Total: 56/199 (28.14%)
AGRANULOCYTOSIS 1/199 (0.50%)
ANAEMIA 1/199 (0.50%)
BONE MARROW FAILURE 1/199 (0.50%)
FEBRILE NEUTROPENIA 11/199 (5.53%)
LEUKOPENIA 1/199 (0.50%)
NEUTROPENIA 1/199 (0.50%)
PANCYTOPENIA 1/199 (0.50%)
ACUTE MYOCARDIAL INFARCTION 1/199 (0.50%)
ATRIAL FLUTTER 1/1... | Contradiction |
At least one participant in the primary trial receiving an oral treatment of film-coated Afatinib tablet at a starting dose of 40 milligram (mg) once daily and weekly 10 minutes intravenous infusions of Vinorelbine 25 mg/meter^2 (meter=m) had a PFS over 9 months. | Outcome Measurement:
Progression-free Survival (PFS)
PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by investigator according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). RECIST is a set of published rules that define when tumors in ... | Entailment |
the primary trial and the secondary trial do not have any overlapping inclusion or exclusion criteria. | 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 ... | Entailment |
A patient who underwent T-cell transfer therapy in the past 2 weeks would be excluded from the primary trial. | Must be 4 weeks since all of the following treatments (recovered from toxicity of prior treatment to Grade 1, excluding alopecia):
immunotherapy; | Entailment |
Patients with Cancer that has spread from a breast tumor to their bone marrow are excluded from the primary trial. | No histologically proven bone marrow metastasis | Entailment |
Cohort 2 of the primary trial and the secondary trial are test groups. | INTERVENTION 1:
Glutamine
10 grams three times a day (orally) for four days and then stop
glutamine: 10 grams three times a day (orally) for four days and then stop
INTERVENTION 2:
Placebo
10 grams three times a day (orally) for four days and then stop
Placebo: 10 grams three times a day (orally) for four... | Contradiction |
the secondary trial has more patients cohorts than the primary trial. | INTERVENTION 1:
Electronic Brachytherapy
Radiation therapy was delivered using the 510(k) cleared Xoft Axxent System. Accelerated partial breast irradiation is the method of radiation therapy administration that has been commonly used by physicians using Iridium-192, but was FDA cleared for use prior to commencing... | Entailment |
Patients will have to undergo an MRI scan for before entry for both the secondary trial and the primary trial, for the primary trial patients will also need to have a brain MR and PET imaging, after study entry. | Inclusion Criteria:
Ability to undergo brain MR and PET imaging
Subjects with prior resection of brain metastases with progressions on brain MRI.
Inclusion Criteria:
clinical and imaging complete or near-complete response on MRI | Entailment |
histologically confirmed invasive ductal breast cancer would result in exclusion from the primary trial, but not from the secondary trial. | Exclusion Criteria:
No histologic evidence of EIC | Contradiction |
the primary trial uses a 3 week cycle for SB-715992 administration. | INTERVENTION 1:
SB-715992
The eligible participants were administered Ispinesib, intravenously as a one-hour infusion on Day 1 of every 21-day treatment cycle, at a dose of 18 mg/m^2. The dosing was repeated for up to multiple cycles, until disease progression or removal from treatment due to an unacceptable toxic... | Entailment |
Not all subjects in the primary trial and the secondary trial will be adminstered 4-8 mCi Tc-99m sestamibi. | INTERVENTION 1:
Overall Population
Each subject served as her own control, with imaging of each mass by both the test and control modalities. Specificity difference is a single measure for the overall ITD population.
INTERVENTION 1:
Molecular Breast Imaging
Molecular breast imaging performed after injection ... | Entailment |
Women of any age can participate in the primary trial or the secondary trial. | 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 5 mm) OR ... | Contradiction |
Nausea and Death are two of the most common adverse events for patients in cohort 1 of the primary trial | Adverse Events 1:
Total: 7/26 (26.92%)
Febrile neutropenia 1/26 (3.85%)
Neutropenia 0/26 (0.00%)
Thrombocytopenia 0/26 (0.00%)
Cardiac failure congestive 0/26 (0.00%)
Extrasystoles 0/26 (0.00%)
Nausea 1/26 (3.85%)
Abdominal pain 0/26 (0.00%)
Constipation 0/26 (0.00%)
Gastrointestinal haemorrhage 0/2... | Entailment |
the primary trial recorded a multitude of patients with chest pain, whereas the secondary trial observed only one patient with abdominal pain. | Adverse Events 1:
Angina pectoris * 1/298 (0.34%)
Adverse Events 1:
Abdominal pain 1/38 (2.63%) | Contradiction |
Cohort 1 and 2 of the primary trial recorded exactly the same number of each type of adverse events. | Adverse Events 1:
Total: 17/94 (18.09%)
Anaemia 2/94 (2.13%)
Lymphadenopathy 0/94 (0.00%)
Angina pectoris 0/94 (0.00%)
Ischaemic cardiomyopathy 0/94 (0.00%)
Myocardial infarction 1/94 (1.06%)
Haemorrhoids 1/94 (1.06%)
Ileus 1/94 (1.06%)
Nausea 1/94 (1.06%)
Vomiting 1/94 (1.06%)
Asthenia 1/94 (1.06... | Entailment |
the primary trial is a phase II trial in which all participants will recieve topical fluocinonide 0.05% cream to apply to their genitalia twice daily for two weeks. | INTERVENTION 1:
Supportive Care (Fluocinonide Cream)
This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.
All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to th... | Entailment |
the primary trial has a 5 year long intervention, the duration of the secondary trial is only a single day after removal of the drains. | 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 days for 5 years; or surgical o... | Contradiction |
the secondary trial and the primary trial both have a placebo arm and a test arm. | INTERVENTION 2:
Fulvestrant & Placebo
Fulvestrant Day 1 & 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus placebo daily x 12 cycles.
Fulvestrant: Fulvestrant 500 mg Day 1 & 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles).
If no evide... | Contradiction |
Throughout the duration of the primary trial, pariticpants receive increasing doses of Fulvestrant. | INTERVENTION 1:
Fulvestrant 250 mg + Tipifarnib 300 mg
Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity | Contradiction |
Patients that have previously been trated with bevacizumab are not eligible for the primary trial. | Exclusion Criteria:
Prior treatment with Abraxane®, carboplatin or bevacizumab, or any taxane for metastatic breast cancer; | Entailment |
the secondary trial and the primary trial both use Pathologic complete response (pCR) as their outcome measure, and use a 6 month time frame. | Outcome Measurement:
Clinical Benefit Rate (CR + PR + SD > 6 Months).
To determine the clinical benefit rate (Complete Response + Partial Response + Stable Disease > 6 months) per Response Evaluation Criteria in Solid tumors (RECIST version 1.0). of MPA monotherapy and MPA + low dose oral cyclophosphamide and meth... | Contradiction |
Patients with stage 3 Cervical carcinoma are excluded from the primary trial. | Inclusion Criteria:
no prior or current neoplasm except for non-melanoma skin cancer, or in situ cancer of the cervix; | Entailment |
2 of the patients in the primary trial were either symptomatic, but able to swallow a modified diet; symptomatic and unable to aliment or hydrate orally or had symptoms associated with life-threatening consequences. | Outcome Measurement:
Number of Participants With Stomatitis Grade 2
The incidence of grade 2 stomatitis was reported. Grade 1 = minimal symptoms, normal diet; grade 2 = symptomatic, but able to swallow a modified diet; grade 3 = symptomatic and unable to aliment or hydrate orally; and grade 4 = symptoms associat... | Entailment |
Between all cohorts in the primary trial and the secondary trial Omega-3-fatty Acids are only used in one cohort. | 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: Participants will receive rad... | Entailment |
Cohort 2 of the primary trial receive a higher dose of Ixabepilone, at a higher frequency, than cohort 1, | INTERVENTION 1:
Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2
Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
INTERVENTION 2:
Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2
Participants received 30 mg/m^2 Ixabepilone as... | Contradiction |
There results section indicates there were no patients in the primary trial with 0 adverse events. | Outcome Measurement:
Number of Participants With Adverse Events (AEs)
Number of participants with any grade of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Daratumumab
Time frame: From first dose to 30 days po... | Entailment |
The interventions in the primary trial and the secondary trial are so different that it is not possible or useful to compare them. | INTERVENTION 1:
Molecular Breast Imaging
Molecular breast imaging performed after injection of 4 mCi Tc-99m sestamibi and again after 8 mCi Tc-99m sestamibi.
INTERVENTION 1:
Control Arm
Mail
Standard Reminder Postcard
INTERVENTION 2:
Family Physician Reminder Letter Arm
Mail
Standard Reminder Postca... | Entailment |
There was over 14 weeks difference in Progression-free Survival between the minimum and maximum PFS in the primary trial. | Outcome Measurement:
Progression-free Survival (PFS)
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Kaplan-Me... | Entailment |
Patients that are not willing to sign and give written informed consent for participation of the primary trial or the secondary trial will not be made to take part. | Inclusion Criteria:
Women >=18 years of age
HER2-negative metastatic breast cancer
Previous adjuvant chemotherapy or hormonal treatment
>=1 measurable target lesion
Exclusion Criteria:
Previous treatment with chemotherapy, an anti-angiogenic agent, or a biologic therapy for advanced or metastatic cancer
Rad... | Entailment |
The Median length of time that a patient in Arm A of the primary trial survived after receiving a TNBC diagnosis was 6 months. | Outcome Measurement:
Progression-free Survival (PFS)
Analysis of the primary endpoint, PFS, will be performed using Cox regression with treatment group as a single covariate.
Time frame: From randomization to the earliest date of documentation of disease progression, up to 5 years
Results 1:
Arm/Group Title: ... | Contradiction |
The majority of patients in the primary trial experienced at least one adverse event. | Adverse Events 1:
Total: 20/88 (22.73%) | Contradiction |
In total more than 5 patients in the primary trial and the secondary trial experienced Earache. | Adverse Events 1:
Total: 107/383 (27.94%)
Anaemia 4/383 (1.04%)
Febrile neutropenia 7/383 (1.83%)
Haemoytique anaemia 0/383 (0.00%)
Leukopenia 1/383 (0.26%)
Neutropenia 6/383 (1.57%)
Thrombocytopenia 2/383 (0.52%)
Anginal pectoris 1/383 (0.26%)
Cardiomyopathy 0/383 (0.00%)
Ear pain 0/383 (0.00%)
A... | Contradiction |
the primary trial and the secondary trial recorded the exact same number of cases of nausea. | Adverse Events 1:
Nausea 1/23 (4.35%)
Adverse Events 1:
Nausea * 1/52 (1.92%) | Entailment |
Candidates for the primary trial do not need to meet a specific life expectancy criteria. | Life expectancy
Not specified | Entailment |
Patients in the primary trial will not be made to take Herceptin© (trastuzumab) or paclitaxel intravenously like those in the secondary trial. | INTERVENTION 1:
Diagnostic (18F-FLT)
Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of resi... | Entailment |
Patients must have a life expectancy over half a year to participate in the primary trial. | Inclusion Criteria:
Patient who have estimated life expectancy of more than six months | Entailment |
A 30% of patients in the primary trial suffered a life-threatening reaction to an infection. | Adverse Events 1:
Total: 9/90 (10.00%)
Febrile neutropenia 2/90 (2.22%)
Ascites 0/90 (0.00%)
Nausea 0/90 (0.00%)
Vomiting 0/90 (0.00%)
Death NOS 1/90 (1.11%)
Fever 0/90 (0.00%)
Other general disorders, administration site conditions 0/90 (0.00%)
Other hepatobiliary disorders 1/90 (1.11%)
Lung infect... | Contradiction |
The only adverse event observed in Patients from both the secondary trial and the primary trial, was Endocervical cancer. | Adverse Events 1:
Total: 14/69 (20.29%)
Febrile neutropenia 0/69 (0.00%)
Anaemia 0/69 (0.00%)
Atrial fibrillation 1/69 (1.45%)
Cardiopulmonary failure 0/69 (0.00%)
Supraventricular extrasystoles 1/69 (1.45%)
Abdominal pain 1/69 (1.45%)
Intestinal obstruction 0/69 (0.00%)
Vomiting 1/69 (1.45%)
... | Contradiction |
Patients with HER2 negative tumours are eligible for the primary trial but not for the secondary trial | Inclusion Criteria:
Inoperable estrogen receptor positive and HER2 negative breast cancer.
Inclusion Criteria:
Patients with newly diagnosed stage I (T>1cm), II or III triple negative breast cancer who have not had definitive breast surgery or received systemic chemotherapy | Contradiction |
the secondary trial and the primary trial do not require participants to be of a particular ethnicity, to be able to speak a specific language or to be above a certain height threshold. | Inclusion criteria:
Female patients >=18 years with proven diagnosis of HER2-overexpressing, histologically confirmed breast cancer
Locally advanced or metastatic disease
Must have disease that can be evaluated according to RECIST 1.1 (Response Evaluation Criteria for Solid Tumours version 1.1)
For trastuzumab ... | Entailment |
Intervention 1 of the primary trial require participants to take 300 mg alpelisib once daily. | INTERVENTION 1:
Alpelisib + Letrozole
Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily. | Entailment |
the primary trial and the secondary trial have the same number of study groups, and are both testing the effectiveness of Full-Field Digital Mammography. | INTERVENTION 1:
FFDM Plus DBT
Breast Images with FFDM and DBT FFDM Plus DBT: FujiFilm Aspire Cristalle System.
This endpoint will be evaluated qualitatively. The Pass Criteria require adequate performance in non-cancer cases (recall rate) and in cancer cases (detection rate).
INTERVENTION 2:
Full-Field Digita... | Contradiction |
Patients under the age of 18, wanting to participate in the primary trial, must discontinue any Antitumoral hormonal treatment prior to study entry, and have a life expectancy of more than 3 months. | Inclusion Criteria:
Antitumoral hormonal treatment must be discontinued prior to enrollment.
Estimated life expectancy of at least 3 months.
Female participants must be at least 18 years of age. | Contradiction |
Females over the age of 20 with no prior chemotherapy with therapeutic intent for current cancer, are eligible for the primary trial. | Inclusion Criteria:
No prior chemotherapy, endocrine therapy or radiation therapy with therapeutic intent for this cancer
Female subjects age 18 - 70 years | Entailment |
Cohort 2 of the primary trial recieves Doxorubicin, cyclophosphamide, Herceptin and docetaxel throughout the cycles of the study. | INTERVENTION 2:
AC Followed by Docetaxel + Herceptin (AC→TH)
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. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly start... | Entailment |
At least 400 participants in the primary trial receiving an oral treatment of film-coated Afatinib tablet at a starting dose of 40 milligram (mg) once daily and weekly 10 minutes intravenous infusions of Vinorelbine 25 mg/meter^2 (meter=m) had a PFS over 9 months. | Outcome Measurement:
Progression-free Survival (PFS)
PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by investigator according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). RECIST is a set of published rules that define when tumors in ... | Contradiction |
Patients with unexplained fever below thirty eight degrees Celsius may be included in the secondary trial and the primary trial. | Exclusion Criteria:
Active infection or unexplained fever >38.5°C during screening.
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:
li... | Contradiction |
Patients must have ductal carcinoma, that can be felt by touch to be eligible for the primary trial. | Inclusion Criteria:
Histologic diagnosis of palpable invasive breast cancer or ductal carcinoma in situ | Contradiction |
the secondary trial and the primary trial do not both use Clinical Benefit Rate as their outcome measure, and they do not use the same time frame. | Outcome Measurement:
Clinical Benefit Rate (CR + PR + SD > 6 Months).
To determine the clinical benefit rate (Complete Response + Partial Response + Stable Disease > 6 months) per Response Evaluation Criteria in Solid tumors (RECIST version 1.0). of MPA monotherapy and MPA + low dose oral cyclophosphamide and meth... | Entailment |
Patients with histologically confirmed, newly diagnosed stage 0 bilateral breast cancer cannot take part in the primary trial, but may still be eligible for the secondary trial. | Patient has bilateral breast cancer or metastatic disease or inflammatory breast cancer
Inclusion Criteria:
Survivors: Latina, has been diagnosed with breast cancer, speaks English or Spanish, has a Caregiver who is willing to participate.
Caregivers: a primary caregiver for a Latina breast cancer survivor, spea... | Entailment |
Patients in the primary trial and the secondary trial are administered daily oral medication. | INTERVENTION 1:
Usual Care
Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.
INTERVENTION 2:
BreastCARE Intervention
Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.
Intervention... | Contradiction |
No less than 2 patients from either cohorts of the primary trial felt nauseous. | Adverse Events 1:
NAUSEA 1/101 (0.99%)
Adverse Events 2:
NAUSEA 0/103 (0.00%) | Contradiction |
There were 2 instances of patients with Atrial tachycardia in the primary trial. | Adverse Events 1:
Total: 3/31 (9.68%)
Edema: limb * 2/31 (6.45%)
Neutrophils/granulocytes (ANC/AGC) * 0/31 (0.00%)
Cardiac General - Other (Specify, __) * [1]0/31 (0.00%)
Cardiac General - Other (Specify, __) * [2]0/31 (0.00%)
Left ventricular diastolic dysfunction * 0/31 (0.00%)
Supraventricular and no... | Contradiction |
10 of the patients in Cohort 1 of the primary trial suffered from Hypotension. | Adverse Events 1:
Hypotension 0/50 (0.00%) | Contradiction |
Only people who have previously been diagnosed with cancer and have no signs of cancer after finishing treatment are eliglbe for the primary trial, as long as they are over the age of 20. | Inclusion Criteria:
breast cancer survivors over 20 years-old | Entailment |
the secondary trial and the primary trial both used MRI and Letrozole for their interventions. | INTERVENTION 1:
Letrozole, Breast Enhancement, Safety
Single arm of healthy postmenopausal women to have two breast MRI (baseline and post-treatment). Letrozole of 12.5 mg/day is given for three successive days just prior to the second MRI.
INTERVENTION 1:
Healthy Volunteers
Healthy women will be screened fo... | Contradiction |
Patients must have a confirmed Postmenopausal status, defined as a lack of menses for over a year, if they are to take part in the primary trial. | Postmenopausal status defined as cessation of menses for >1 year or FSH > 20 mIU/mL (within the past month) | Entailment |
Any patients with breast cancer above stage, currently receiving radiation therapy or biotherapy are excluded from the primary trial. | Exclusion Criteria:
Patients with stage IV breast cancer or undergoing chemotherapy, radiation therapy, immunotherapy, or biotherapy for current breast cancer. | Entailment |
the primary trial and the secondary trial are both evaluating patient assisted imaging interventions. | INTERVENTION 1:
All Study Participants, PA Compression Image Sets
All image sets (30 patient-assisted compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers.
INTERVENTION 2:
All Study Participants, TC Compression Image Sets
All image sets (30 TC compressi... | Contradiction |
the secondary trial and the primary trial do not test the same modalities of cancer treatments. | INTERVENTION 1:
Lapatinib Plus Capecitabine
Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and admini... | Entailment |
The difference in Percentage of Participants With At Least 1 Adverse Event (AE) During the Treatment Period in both cohorts of the primary trial is less than 1%. | Outcome Measurement:
Percentage of Participants With At Least 1 Adverse Event (AE) During the Treatment Period
Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/un... | Entailment |
Although there is a much higher percentage of patients with Thrombocytopenia in the secondary trial than in cohort 1 of the primary trial, no robust comparisons can be made due to the significant differences in cohort sizes. | Adverse Events 1:
Total: 59/199 (29.65%)
Anaemia 7/199 (3.52%)
Thrombocytopenia 2/199 (1.01%)
Adverse Events 1:
Total: 6/8 (75.00%)
Thrombocytopenia 1/8 (12.50%) | Entailment |
Men with Left ventricular ejection fraction > 50% are excluded from participating in the primary trial. | LVEF 50% as measured by echocardiogram or MUGA scan
Male or female | Contradiction |
The highest number of occurences for any adverse event in both the primary trial and the secondary trial was 2. | Adverse Events 1:
Total: 39/2240 (1.74%)
Supraven.arrhyth. Atrial fibrillation 1/2240 (0.04%)
Cardiac ischemia/infarction 2/2240 (0.09%)
Valvular heart disease 1/2240 (0.04%)
Cardiac General - Other 2/2240 (0.09%)
Endocrine - Other 1/2240 (0.04%)
Ocular - Other 1/2240 (0.04%)
Colitis 2/2240 (0.09%)
Di... | Entailment |
the secondary trial exclusively uses radiotherapy in its intervention, whereas the primary trial gives its patient cohorts Stem Cell Transplants on the first day of the study. | INTERVENTION 1:
High-dose Chemotherapy
Carboplatin + Cyclophosphamide + Thiotepa
Carboplatin : Target AUC of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion.
Thiotepa : 120 mg/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.
Stem Cell Transplant : ... | Contradiction |
Patients with Cervical carcinoma in situ are excluded from the primary trial. | Inclusion Criteria:
no prior or current neoplasm except for non-melanoma skin cancer, or in situ cancer of the cervix; | Contradiction |
There were no patients with paranasal sinus reactions in the primary trial. | Adverse Events 1:
Total: 21/107 (19.63%)
Febrile neutropenia * 10/107 (9.35%)
Neutropenia * 1/107 (0.93%)
Left ventricular dysfunction * 0/107 (0.00%)
Angina pectoris * 0/107 (0.00%)
Cardiac failure congestive * 0/107 (0.00%)
Diarrhoea * 2/107 (1.87%)
Abdominal strangulated hernia * 0/107 (0.00%)
Duod... | Entailment |
Patients with cytologically confirmed, metastatic, early stage invasive breast cancer with an Allred score of 3 are eligible for the primary trial. | Inclusion Criteria:
Patients must have histologically or cytologically confirmed early stage, ER-positive (Allred score 3), invasive breast cancer that is not either locally advanced by criteria other than size or inflammatory, and is not metastatic. - Patients must be candidates for surgical removal of the tumor by ... | Contradiction |
the primary trial administers the placebo and Urea/Lactic Acid Cream in the same frequency and on the same areas of the skin. | INTERVENTION 1:
Urea/Lactic Acid Cream
Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily.
INTERVENTION 2:
Placebo Cream
Patients receive placebo cream applied to palms and soles twice daily. | Entailment |
In order to participate in the primary trial, participants must be aware of where they are, and what day it is. | Inclusion Criteria:
Cognitively oriented to time, place, and person (determined via nurse recruiter) | Entailment |
There was a dental adverse event in the primary trial. | Adverse Events 1:
Total: 20/52 (38.46%)
Febrile bone marrow aplasia * 5/52 (9.62%)
Febrile neutropenia * 6/52 (11.54%)
Leukopenia * 6/52 (11.54%)
Atrial tachycardia * 1/52 (1.92%)
Vomiting * 1/52 (1.92%)
Tooth loss * 1/52 (1.92%)
Hyperthermia * 1/52 (1.92%)
Malaise * 1/52 (1.92%)
Pyrexia * 1/52 (1.9... | Entailment |
Neither the primary trial or the secondary trial require participants to practice yoga while Wearing a Fitbit activity monitoring device. | INTERVENTION 1:
Group I (SparkPeople Program)
Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.
Participants receive weekly motivational reminders to log into the we... | Entailment |
Patients in the primary trial receive an Infusion of Perflutren Lipid Microspheres, whereas in the secondary trial subjects are implanted with a Meso BioMatrix Acellular Peritoneum Matrix. | INTERVENTION 1:
Definity Infusion
Infusion of Definity (Perflutren Lipid Microspheres)
Definity infusion: 3 ml of Perflutren Lipid Microspheres (Definity) mixed in 50 ml of saline is infused at a rate of approximately 4ml/min
INTERVENTION 1:
Meso BioMatrix Acellular Peritoneum Matrix
All subjects had the M... | Entailment |
Cohort 1 of the primary trial recieves less than 60% of cohort 2's dose of LA-EP2006. | INTERVENTION 1:
Neratinib 40 mg
Neratinb 40 mg qd
INTERVENTION 2:
Neratinib 80 mg
Neratinib 80 mg qd | Entailment |
There were 0 observed cases of Tibia or Fibula fractures in the primary trial or the secondary trial. | Adverse Events 1:
Total: 16/149 (10.74%)
Anaemia 0/149 (0.00%)
Febrile neutropenia 7/149 (4.70%)
Neutropenia 1/149 (0.67%)
Pancytopenia 1/149 (0.67%)
Atrial fibrillation 2/149 (1.34%)
Cardiac failure congestive 0/149 (0.00%)
Abdominal pain 0/149 (0.00%)
Diarrhoea 2/149 (1.34%)
Dyspepsia 0/149 (0.00%... | Contradiction |
In order to be eligible for the primary trial, patients must not have prior radiation, anthracycline or systemic anticancer therapy , and must have T1-4, N1 and M1 bilateral breast cancer. | Exclusion Criteria:
Prior systemic anticancer therapy for breast cancer (immunotherapy, hormonotherapy, chemotherapy).
Prior anthracycline therapy or taxoids (paclitaxel, docetaxel) for any malignancy.
Prior radiation therapy for breast cancer.
Any T4 or N1-3 or M1 breast cancer. | Contradiction |
In total Over 82% patient in the primary trial achieve Recurrence-free Survival after 5 years. | Outcome Measurement:
Recurrence-free Survival
2 years for the primary analysis + 3 additional years for secondary analysis (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)
Time frame: 5 years
Results 1:
Ar... | Entailment |
INR of 1.35 is enough for participation in the primary trial and the secondary trial. | Inclusion Criteria:
International normalized ratio (INR) <=1.5 or prothrombin time (PT)/partial
Inclusion Criteria:
Female subjects participating in FMSU004A protocol with known clinical status
Exclusion Criteria:
Subjects with unknown clinical status not participating in FMSU004A protocol. | Contradiction |
One patient in cohort 2 of the primary trial crashed their motorbike. | Adverse Events 2:
Total: 8/537 (1.49%)
Hypertension 1/537 (0.19%)
Acoustic Neuroma 0/537 (0.00%)
Diarrhea 1/537 (0.19%)
Colitis 0/537 (0.00%)
Elevated ALT or AST enzyme 0/537 (0.00%)
Diagnosis of Uterine Cancer 2/537 (0.37%)
Motorcycle accident 1/537 (0.19%)
Fall 1/537 (0.19%)
Surgery 2/537 (0.37%) | Entailment |
There was over 10 more cases of adverse events in cohort 2 than in cohort 1 of the primary trial. | Adverse Events 1:
Total: 2/15 (13.33%)
Adverse Events 2:
Total: 11/35 (31.43%) | Contradiction |
A higher percentage of cohort 1 of the primary trial showed signs of fever, compared to cohort 2. | Adverse Events 1:
Fever * 2/41 (4.88%)
Adverse Events 2:
Fever * 0/5 (0.00%) | Entailment |
59% of Arm A of the primary trial achieved a best overall response, classified as a complete or partial (confirmed) tumor response or stable disease for at least 6 months. | Outcome Measurement:
Clinical Benefit Response (Independent Reviewer-assessed)
CBR is defined as the percentage of participants receiving at least one dose of study medication who achieved a best overall response classified as a complete or partial (confirmed) tumor response or stable disease for at least 6 months... | Entailment |
There is the same number of cases of Diplopia in the primary trial as anemia in the secondary trial. | Adverse Events 1:
Total: 1/6 (16.67%)
Angina pectoris 0/6 (0.00%)
Pericardial effusion 0/6 (0.00%)
Diplopia 0/6 (0.00%)
Abdominal pain 0/6 (0.00%)
Colitis 0/6 (0.00%)
Gastritis 0/6 (0.00%)
Nausea 0/6 (0.00%)
Vomiting 0/6 (0.00%)
Fatigue 0/6 (0.00%)
General physical health deterioration 0/6 (0.00%)... | Entailment |
the primary trial studies the effects of CTX/IMQ/RT and Epothilone on Central Nervous System (CNS) Progression-free Survival(PFS), 9 weeks after the start of treatment. | Outcome Measurement:
Systemic Tumor Response Rates (Complete Response+Partial Response)
The systemic tumor response refers to the response at the time of best overall response. The response criteria are specially adapted from Response Evaluation Criteria in Solid Tumor for Immunotherapies (Wolchok, et al., 2009).
... | Contradiction |
Patients diagnosed with intradural tumors are excluded from the primary trial. | Exclusion Criteria:
No metastatic disease to the Central Nervous System | Entailment |
the primary trial participants will receive either Lapatinib, WBRT or Herceptin. | INTERVENTION 1:
Lapatinib,Whole Brain Radiation,Herceptin
Lapatinib before and during Whole Brain Radiation Therapy (WBRT), then Herceptin 4mg/kg IV weekly | Contradiction |
There was less than a 5% difference in the results from the 9 mg and 18 mg group in the primary trial. | Outcome Measurement:
Clinical Benefit Rate, in Centrally Confirmed Androgen Receptor (AR)+ Subjects
To estimate the clinical benefit rate (defined as complete response, partial response, or stable disease) according to RECIST 1.1, in subjects with estrogen receptor positive/androgen receptor positive (ER+/AR+) BC ... | Entailment |
the primary trial has a topical intervention, whereas the secondary trial has both oral and IV interventions. | INTERVENTION 1:
Mometasone
Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
INTERVENTION 2:
Placebo
Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.
INTERVENTION 1: ... | Entailment |
All patients in the Letrozole group of the primary trial had a decreased Bone Mineral Density of the Lumbar Spine after 3 years. | 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 years and annually... | Contradiction |
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