TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women With Endocrine Responsive Breast Cancer
Brief Summary: RATIONALE: Estrogen can stimulate the growth of breast tumor cells. Ovarian function suppression combined with hormone therapy using tamoxifen or exemestane may fight breast cancer by reducing the production of estrogen. It is not yet known whether suppression of ovarian function plus either tamoxifen or exemestane is more effective than tamoxifen alone in preventing the recurrence of hormone-responsive breast cancer.

PURPOSE: This randomized phase III trial studies ovarian suppression with either tamoxifen or exemestane to see how well they work compared to tamoxifen alone in treating premenopausal women who have undergone surgery for hormone-responsive breast cancer.


Options:
A: Assessment of arthralgia scores and patients' compliance within the first year of anastrozole treatment, stratified by upfront and switch therapy as well as assessment of the relationship between compliance and arthralgia scores. (12 months)
B: Change from baseline in musculoskeletal pain and 250HD levels (3 monthly during one year)
C: assess efficacy of duloxetine (QD) vs placebo on pain in patients, w/ or w/o MDD during a 6-month therapy phase; evaluate change in pain measured by Brief Pain Inventory score; evaluate endpoint of patient-reported improvement on the Patient's Global Impression of Improvement scale
D: Disease-free Survival (5-year estimates, reported at a median follow-up of 67 months.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women With Endocrine Responsive Breast Cancer
Brief Summary: RATIONALE: Estrogen can stimulate the growth of breast tumor cells. Ovarian function suppression combined with hormone therapy using tamoxifen or exemestane may fight breast cancer by reducing the production of estrogen. It is not yet known whether suppression of ovarian function plus either tamoxifen or exemestane is more effective than tamoxifen alone in preventing the recurrence of hormone-responsive breast cancer.

PURPOSE: This randomized phase III trial studies ovarian suppression with either tamoxifen or exemestane to see how well they work compared to tamoxifen alone in treating premenopausal women who have undergone surgery for hormone-responsive breast cancer.


Options:
A: N/A
B: Disease-free Survival (5-year estimates, reported at a median follow-up of 67 months.)
C: all cause recurrence (the first 5 years after surgery)
D: Mammographic percentage density at 18months (18months after enrolled)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women With Endocrine Responsive Breast Cancer
Brief Summary: RATIONALE: Estrogen can stimulate the growth of breast tumor cells. Ovarian function suppression combined with hormone therapy using tamoxifen or exemestane may fight breast cancer by reducing the production of estrogen. It is not yet known whether suppression of ovarian function plus either tamoxifen or exemestane is more effective than tamoxifen alone in preventing the recurrence of hormone-responsive breast cancer.

PURPOSE: This randomized phase III trial studies ovarian suppression with either tamoxifen or exemestane to see how well they work compared to tamoxifen alone in treating premenopausal women who have undergone surgery for hormone-responsive breast cancer.


Options:
A: Change from Baseline in Arthralgia Severity (6 months); Change from Baseline in Arthralgia Severity (12 months)
B: Stimulated ln (TNF-a) (Immediately post-treatment and 3 months post-treatment); Stimulated ln (IL-6) (Immediately post-treatment and 3 months post-treatment); Stimulated ln (IL-1b) (Immediately post-treatment and 3 months post-treatment); MFSI-SF Fatigue (Immediately post-treatment and 3 months post-treatment); Vitality, SF-36 (Immediately post-treatment and 3 months post-treatment); CES-D (Immediately post-treatment and 3 months post-treatment)
C: Assessment of arthralgia scores and patients' compliance within the first year of anastrozole treatment, stratified by upfront and switch therapy as well as assessment of the relationship between compliance and arthralgia scores. (12 months)
D: Disease-free Survival (5-year estimates, reported at a median follow-up of 67 months.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women With Endocrine Responsive Breast Cancer
Brief Summary: RATIONALE: Estrogen can stimulate the growth of breast tumor cells. Ovarian function suppression combined with hormone therapy using tamoxifen or exemestane may fight breast cancer by reducing the production of estrogen. It is not yet known whether suppression of ovarian function plus either tamoxifen or exemestane is more effective than tamoxifen alone in preventing the recurrence of hormone-responsive breast cancer.

PURPOSE: This randomized phase III trial studies ovarian suppression with either tamoxifen or exemestane to see how well they work compared to tamoxifen alone in treating premenopausal women who have undergone surgery for hormone-responsive breast cancer.


Options:
A: Rate of Premature Ovarian Failure at 2 Years (2 years)
B: Chemotherapy-induced early menopause as measured by follicle-stimulating hormone, 17 beta estradiol levels, and menstrual activity resumption at 1 year following the completion of chemotherapy
C: Disease-free Survival (5-year estimate reported at a median follow-up of 72 months)
D: Disease-free Survival (5-year estimates, reported at a median follow-up of 67 months.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Trial Evaluating The Role Of Exemestane Plus GnRH Analogue As Adjuvant Therapy For Premenopausal Women With Endocrine Responsive Breast Cancer
Brief Summary: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using triptorelin, exemestane, and tamoxifen may fight breast cancer by blocking the use of estrogen. It is not yet known whether giving triptorelin together with exemestane is more effective than triptorelin and tamoxifen in treating hormone-responsive breast cancer.

PURPOSE: This randomized phase III trial is studying triptorelin and exemestane to see how well they work compared to triptorelin and tamoxifen in treating premenopausal women with hormone-responsive breast cancer.


Options:
A: Disease-free Survival (5-year estimate reported at a median follow-up of 72 months)
B: Average Joint Pain According to BPI-SF (Weeks 2, 6, 12, and 24; Week 12 reported)
C: assess efficacy of duloxetine (QD) vs placebo on pain in patients, w/ or w/o MDD during a 6-month therapy phase; evaluate change in pain measured by Brief Pain Inventory score; evaluate endpoint of patient-reported improvement on the Patient's Global Impression of Improvement scale
D: Disease free survival. (Up to end of year 2015)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Trial Evaluating The Role Of Exemestane Plus GnRH Analogue As Adjuvant Therapy For Premenopausal Women With Endocrine Responsive Breast Cancer
Brief Summary: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using triptorelin, exemestane, and tamoxifen may fight breast cancer by blocking the use of estrogen. It is not yet known whether giving triptorelin together with exemestane is more effective than triptorelin and tamoxifen in treating hormone-responsive breast cancer.

PURPOSE: This randomized phase III trial is studying triptorelin and exemestane to see how well they work compared to triptorelin and tamoxifen in treating premenopausal women with hormone-responsive breast cancer.


Options:
A: Disease-free Survival (5-year estimate reported at a median follow-up of 72 months)
B: all cause recurrence (the first 5 years after surgery)
C: DFS (5 Years)
D: Disease-free Survival (5-year estimates, reported at a median follow-up of 67 months.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Trial Evaluating The Role Of Exemestane Plus GnRH Analogue As Adjuvant Therapy For Premenopausal Women With Endocrine Responsive Breast Cancer
Brief Summary: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using triptorelin, exemestane, and tamoxifen may fight breast cancer by blocking the use of estrogen. It is not yet known whether giving triptorelin together with exemestane is more effective than triptorelin and tamoxifen in treating hormone-responsive breast cancer.

PURPOSE: This randomized phase III trial is studying triptorelin and exemestane to see how well they work compared to triptorelin and tamoxifen in treating premenopausal women with hormone-responsive breast cancer.


Options:
A: Disease-free Survival (5-year estimates, reported at a median follow-up of 67 months.)
B: Assessment of arthralgia scores and patients' compliance within the first year of anastrozole treatment, stratified by upfront and switch therapy as well as assessment of the relationship between compliance and arthralgia scores. (12 months)
C: Stimulated ln (TNF-a) (Immediately post-treatment and 3 months post-treatment); Stimulated ln (IL-6) (Immediately post-treatment and 3 months post-treatment); Stimulated ln (IL-1b) (Immediately post-treatment and 3 months post-treatment); MFSI-SF Fatigue (Immediately post-treatment and 3 months post-treatment); Vitality, SF-36 (Immediately post-treatment and 3 months post-treatment); CES-D (Immediately post-treatment and 3 months post-treatment)
D: Disease-free Survival (5-year estimate reported at a median follow-up of 72 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Trial Evaluating The Role Of Exemestane Plus GnRH Analogue As Adjuvant Therapy For Premenopausal Women With Endocrine Responsive Breast Cancer
Brief Summary: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using triptorelin, exemestane, and tamoxifen may fight breast cancer by blocking the use of estrogen. It is not yet known whether giving triptorelin together with exemestane is more effective than triptorelin and tamoxifen in treating hormone-responsive breast cancer.

PURPOSE: This randomized phase III trial is studying triptorelin and exemestane to see how well they work compared to triptorelin and tamoxifen in treating premenopausal women with hormone-responsive breast cancer.


Options:
A: Resumption of menstruation (1 year)
B: Disease-free Survival (5-year estimate reported at a median follow-up of 72 months)
C: Disease-free Survival (5-year estimates, reported at a median follow-up of 67 months.)
D: Chemotherapy-induced early menopause as measured by follicle-stimulating hormone, 17 beta estradiol levels, and menstrual activity resumption at 1 year following the completion of chemotherapy

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Excisional Surgery Versus Imiquimod 5% Cream for Nodular and Superficial Basal Cell Carcinoma
Brief Summary: RATIONALE: Biological therapies such as imiquimod use different ways to stimulate the immune system and stop cancer cells from growing. It is not yet known if topical imiquimod is more effective than surgery in treating basal cell skin cancer.

PURPOSE: This randomized phase III trial is studying how well topical imiquimod works compared to surgery in treating patients with basal cell skin cancer.


Options:
A: Objective Response Rate (ORR) Based on Central Review According to mRECIST (for Locally Advanced Basal Cell Carcinoma (laBCC)) and RECIST 1.1 (for Metastatic Basal Cell Carcinoma (mBCC)) Per Primary Efficacy Analysis Set (pEAS) (6 months); Objective Response Rate (ORR) Based on Central Review According to mRECIST (for Locally Advanced Basal Cell Carcinoma (laBCC)) and RECIST 1.1 (Metastatic Basal Cell Carcinoma (mBCC)) Per Full Analysis Set (FAS) (6 months)
B: Absence of local recurrence at 3 years after start of treatment
C: defect size after surgery (immediately after surgery)
D: Objective Response (OR) Determined by the Independent Review Facility (From study initiation (enrollment of first patient) through 9 months following the first treatment of the last enrolled patient (clinical cutoff date of 26 November 2010), up to 90 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Excisional Surgery Versus Imiquimod 5% Cream for Nodular and Superficial Basal Cell Carcinoma
Brief Summary: RATIONALE: Biological therapies such as imiquimod use different ways to stimulate the immune system and stop cancer cells from growing. It is not yet known if topical imiquimod is more effective than surgery in treating basal cell skin cancer.

PURPOSE: This randomized phase III trial is studying how well topical imiquimod works compared to surgery in treating patients with basal cell skin cancer.


Options:
A: Peer review of subject images using the Total Inflammatory Lesion Count at the end of active recruitment (6 months)
B: Absence of local recurrence at 3 years after start of treatment
C: Number of Participants With Suspicious Tumors Detected After Inspection of Problem Area and Inspection of the Full Body. (one year)
D: Objective Response (OR) Determined by the Independent Review Facility (From study initiation (enrollment of first patient) through 9 months following the first treatment of the last enrolled patient (clinical cutoff date of 26 November 2010), up to 90 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Excisional Surgery Versus Imiquimod 5% Cream for Nodular and Superficial Basal Cell Carcinoma
Brief Summary: RATIONALE: Biological therapies such as imiquimod use different ways to stimulate the immune system and stop cancer cells from growing. It is not yet known if topical imiquimod is more effective than surgery in treating basal cell skin cancer.

PURPOSE: This randomized phase III trial is studying how well topical imiquimod works compared to surgery in treating patients with basal cell skin cancer.


Options:
A: Sensitivity and Specificity (Within 120 days of Data Lock)
B: All-cause mortality (Until December 2015)
C: Objective Response (OR) Determined by the Independent Review Facility (From study initiation (enrollment of first patient) through 9 months following the first treatment of the last enrolled patient (clinical cutoff date of 26 November 2010), up to 90 weeks)
D: Absence of local recurrence at 3 years after start of treatment

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Excisional Surgery Versus Imiquimod 5% Cream for Nodular and Superficial Basal Cell Carcinoma
Brief Summary: RATIONALE: Biological therapies such as imiquimod use different ways to stimulate the immune system and stop cancer cells from growing. It is not yet known if topical imiquimod is more effective than surgery in treating basal cell skin cancer.

PURPOSE: This randomized phase III trial is studying how well topical imiquimod works compared to surgery in treating patients with basal cell skin cancer.


Options:
A: Sensitivity and Specificity (Within 120 days of Data Lock)
B: Absence of local recurrence at 3 years after start of treatment
C: All-cause mortality (Until December 2015)
D: Objective Response (OR) Determined by the Independent Review Facility (From study initiation (enrollment of first patient) through 9 months following the first treatment of the last enrolled patient (clinical cutoff date of 26 November 2010), up to 90 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Excisional Surgery Versus Imiquimod 5% Cream for Nodular and Superficial Basal Cell Carcinoma
Brief Summary: RATIONALE: Biological therapies such as imiquimod use different ways to stimulate the immune system and stop cancer cells from growing. It is not yet known if topical imiquimod is more effective than surgery in treating basal cell skin cancer.

PURPOSE: This randomized phase III trial is studying how well topical imiquimod works compared to surgery in treating patients with basal cell skin cancer.


Options:
A: Number of Participants With Suspicious Tumors Detected After Inspection of Problem Area and Inspection of the Full Body. (one year)
B: Objective Response (OR) Determined by the Independent Review Facility (From study initiation (enrollment of first patient) through 9 months following the first treatment of the last enrolled patient (clinical cutoff date of 26 November 2010), up to 90 weeks)
C: Absence of local recurrence at 3 years after start of treatment
D: All-cause mortality (Until December 2015)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Excisional Surgery Versus Imiquimod 5% Cream for Nodular and Superficial Basal Cell Carcinoma
Brief Summary: RATIONALE: Biological therapies such as imiquimod use different ways to stimulate the immune system and stop cancer cells from growing. It is not yet known if topical imiquimod is more effective than surgery in treating basal cell skin cancer.

PURPOSE: This randomized phase III trial is studying how well topical imiquimod works compared to surgery in treating patients with basal cell skin cancer.


Options:
A: All-cause mortality (Until December 2015)
B: Comparison between one stop shop using reflectance confocal microscopy in the surgical treatment of BCC and current standard of care using punch biopsy, by assessing incomplete surgical excision on the final pathology report. (Within the first week after surgical excision of suspected BCC lesion)
C: Absence of local recurrence at 3 years after start of treatment
D: Sensitivity and Specificity (Within 120 days of Data Lock)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Patients who have deep vein thrombosis (blood clot in the leg) will be treated in this study. The purpose of the study is to compare the safety and effectiveness of a new injectable anticoagulant (blood thinning) drug administered once each week, SanOrg34006, with the standard way of treating deep vein thrombosis. The standard treatment includes injections or infusions of an anticoagulant drug (Unfractionated Heparin or low molecular weight heparin) for about a week, followed by vitamin K antagonist (VKA) anticoagulant tablets (warfarin or acenocoumarol) which are taken by mouth. Eligible patients will be assigned to treatment with either SanOrg34006 or the combination of Unfractionated Heparin or low molecular weight heparin plus a VKA (warfarin or acenocoumarol) by random chance. Treatment will be known to both patients and their doctors.


Options:
A: Number of Participants With at Least on Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 47 (Baseline to Day 47)
B: Bioequipotency sub-study: idrabiotaparinux/idraparinux ratio for pharmacodynamic exposure parameters (Day 183); Avidin neutralizing effect substudy: decrease in anti-Xa activity between the start and end of the avidin infusion (Day 183 to Day 188)
C: Number of Participants With Venous Thromboembolisms and/or Major Hemorrhages to Day 11 (11 days)
D: symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Patients who have deep vein thrombosis (blood clot in the leg) will be treated in this study. The purpose of the study is to compare the safety and effectiveness of a new injectable anticoagulant (blood thinning) drug administered once each week, SanOrg34006, with the standard way of treating deep vein thrombosis. The standard treatment includes injections or infusions of an anticoagulant drug (Unfractionated Heparin or low molecular weight heparin) for about a week, followed by vitamin K antagonist (VKA) anticoagulant tablets (warfarin or acenocoumarol) which are taken by mouth. Eligible patients will be assigned to treatment with either SanOrg34006 or the combination of Unfractionated Heparin or low molecular weight heparin plus a VKA (warfarin or acenocoumarol) by random chance. Treatment will be known to both patients and their doctors.


Options:
A: symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months.
B: symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months
C: Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE) (From Day 1 to Day 90 (±7 days))
D: Symptomatic recurrent PE/DVT during the 6-month study treatment period.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Dipyridamole Plus Aspirin on Hemodialysis Graft Patency
Brief Summary: The objective of the study is to determine whether Aggrenox (Boehringer-Ingelheim) prolongs primary unassisted patency in newly created arteriovenous grafts. This record previously included information for both the GRAFT and FISTULA trials.


Options:
A: the rate of major adverse cardiovascular events (12 MONTHS)
B: Composite of death, myocardial infarction or stroke occurring in the time window from 31 days and up to 24 months after intervention. (24 months)
C: N/A
D: Percentage of Participants With a Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke (Randomization through end of study (30-month visit))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Dipyridamole Plus Aspirin on Hemodialysis Graft Patency
Brief Summary: The objective of the study is to determine whether Aggrenox (Boehringer-Ingelheim) prolongs primary unassisted patency in newly created arteriovenous grafts. This record previously included information for both the GRAFT and FISTULA trials.


Options:
A: Arteriovenous Fistulae Maturation (6 months)
B: Time to AVF Primary Unassisted Patency (Days from AVF creation until the first occurrence of either access thrombosis or procedure to restore or maintain patency, assessed up to 1 year); Kaplan-Meier Estimate of Secondary AVF Patency (Median time from AVF creation until AVF abandonment (secondary patency), assessed up to 1 year)
C: N/A
D: Primary safety endpoint: Freedom from severe (i.e. performance of daily activities is compromised) or unanticipated device related adverse events (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Dipyridamole Plus Aspirin on Hemodialysis Graft Patency
Brief Summary: The objective of the study is to determine whether Aggrenox (Boehringer-Ingelheim) prolongs primary unassisted patency in newly created arteriovenous grafts. This record previously included information for both the GRAFT and FISTULA trials.


Options:
A: N/A
B: N/A
C: Technical success (1 minute after the final balloon angioplasty); Primary patency (1 year)
D: Percent of Participants With Treatment Area Primary Patency (TAPP) (6 month follow-up)

Answer: B