TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase III Multicenter Trial of Neoadjuvant Docetaxel (Taxotere) Plus Cisplatin Plus 5-Fluorouracil Versus Neoadjuvant Cisplatin Plus 5-Fluorouracil in Patients With Locally Advanced Inoperable Squamous Cell Carcinoma of the Head and Neck
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug and combining chemotherapy with radiation therapy may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective for advanced head and neck cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy plus radiation therapy in treating patients who have advanced head and neck cancer.


Options:
A: Phase II: Clinical objective response rate, at the end of inducted chemotherapy (groups A and B) and at the end of combined treatment (groups A, B and C). (16 weeks); Phase III: Surveillance with no progression after two years. (2 years)
B: Disease free survival (3 years)
C: N/A
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer
Brief Summary: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using raloxifene and tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells.

PURPOSE: Randomized double-blinded clinical trial to compare the effectiveness of raloxifene with that of tamoxifen in preventing breast cancer in postmenopausal women.


Options:
A: Incidence of invasive breast cancer; superiority of one of the therapies. (Time from randomization to the occurance of invasive breast cancer.)
B: Percentage of serum estradiol suppression in postmenopausal women at high risk for breast cancer (Baseline to week 30)
C: Number of Participants With Major Cardiovascular Events (a Combined Endpoint of Nonfatal Myocardial Infarction, Nonfatal Stroke, and Total Cardiovascular Death) (Average follow-up 10.1 years); Number of Participants With Cancer, Excluding Nonmelanoma Skin Cancer (Average follow-up 10.1 years)
D: The primary efficacy parameter was reduction in incident new vertebral fractures assessed by spinal radiographs (anterior-posterior and lateral) (3 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial Comparing the Safety and Efficacy of Adriamycin and Cyclophosphamide Followed by Taxol (AC-T) to That of Adriamycin and Cyclophosphamide Followed by Taxol Plus Herceptin (AC-T+H) in Node-Positive Breast Cancer Patients Who Have Tumors That Overexpress HER2
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy plus trastuzumab is more effective than combination chemotherapy alone for treating breast cancer.

PURPOSE: This randomized phase III trial is studying how well giving combination chemotherapy together with trastuzumab works compared to combination chemotherapy alone in treating women with node-positive stage II or stage IIIA breast cancer that overexpresses HER2.


Options:
A: Disease Free Survival (DFS) (Time from randomization through 5 years); Cardiotoxicity (time from randomization through 4 months)
B: Number of Participants With Scores of Either <2.5 or >=2.5 on the Breast Cancer Treatment Outcome Scale (BCTOS) Cosmesis (3 years after completing radiation therapy)
C: Change from baseline in pulmonary function and heart function tests (From end of treatment up to 3 years after treatment)
D: Duration of DFS (Time from registration to first adverse event, assessed up to 15 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Study of Doxorubicin-Cyclophosphamide Therapy Followed by Paclitaxel or Docetaxel Given Weekly or Every 3 Weeks in Patients With Axillary Node-Positive Breast Cancer
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective for breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of combination chemotherapy in treating women who have stage II or stage IIIA breast cancer that has spread to the lymph nodes.


Options:
A: Treatment success.Treatment success is defined as the ability to deliver 6 courses of chemotherapy without premature termination for progression, death or unacceptable toxicity (After 6 courses of chemotherapy i.e 4.5 to 6 months (depending on the arm))
B: Progression-free Survival (From study entry until first disease progression, death or date of last contact, up to 6 years)
C: Duration of recurrence free survival.
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Study of Doxorubicin-Cyclophosphamide Therapy Followed by Paclitaxel or Docetaxel Given Weekly or Every 3 Weeks in Patients With Axillary Node-Positive Breast Cancer
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective for breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of combination chemotherapy in treating women who have stage II or stage IIIA breast cancer that has spread to the lymph nodes.


Options:
A: Relapse Free Survival (RFS) 4 vs. 6 Cycles (from baseline up to 4 years); Duration of Disease Free Survival (RFS) (from baseline up to 6.4 years)
B: Disease-Free Survival (after 10 years follow up)
C: disease free survival (at 5 years)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Study of Purged Versus Unpurged Peripheral Blood Stem Cell Transplant Following Dose Intensive Induction Therapy for High Risk Neuroblastoma
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: This randomized phase III trial is studying peripheral stem cell transplantation with treated peripheral stem cells following combination chemotherapy to see how well it works compared to peripheral stem cell transplantation with untreated peripheral stem cells following combination chemotherapy in treating patients with neuroblastoma.


Options:
A: Event Free Survival (R1: MAT therapy) (Up to three years); Event Free Survival (immunotherapy) (Up to three years); Complete metastatic response (R3: Induction therapy) (Up to 95 days); Event free survival (R3: Induction therapy) (Up to three years)
B: Event-free survival rate (Time from study registration until the time of the first occurrence of either relapse, progression, secondary malignancy, or death, or until the time of last contact with the patient if none of these events occurs, assessed up to 6 years); Rate of occurrence of toxic (non disease-related) deaths where a toxic death will be "counted" if it occurs prior to the initiation of the immunotherapy (Up to day 42)
C: N/A
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Study of Purged Versus Unpurged Peripheral Blood Stem Cell Transplant Following Dose Intensive Induction Therapy for High Risk Neuroblastoma
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: This randomized phase III trial is studying peripheral stem cell transplantation with treated peripheral stem cells following combination chemotherapy to see how well it works compared to peripheral stem cell transplantation with untreated peripheral stem cells following combination chemotherapy in treating patients with neuroblastoma.


Options:
A: N/A
B: N/A
C: N/A
D: Event-free survival rate (Time from study registration until the time of the first occurrence of either relapse, progression, secondary malignancy, or death, or until the time of last contact with the patient if none of these events occurs, assessed up to 6 years); Rate of occurrence of toxic (non disease-related) deaths where a toxic death will be "counted" if it occurs prior to the initiation of the immunotherapy (Up to day 42)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Study to Evaluate Letrozole as Adjuvant Endocrine Therapy for Postmenopausal Women With Receptor (ER and/or PgR) Positive Tumors
Brief Summary: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by reducing the production of estrogen. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. If is not yet known which treatment regimen is most effective for breast cancer.

PURPOSE: Randomized double-blind phase III trial to compare the effectiveness of letrozole with that of tamoxifen in treating postmenopausal women who have breast cancer that has been surgically removed.


Options:
A: Disease free survival. (Up to end of year 2015)
B: Change in Item #3 (Average) of the Brief Pain Inventory (BPI) Average Pain From Baseline to Month 3 (From baseline to 3 months); Improvement in BPI Average Pain From Baseline to Month 3 (Up to 3 months); Change in BPI Average Change From Baseline Pain Score to Month Six Average Pain Score (Baseline and 6 months); Change in BPI Average Pain From Baseline to Month 1-6 (Baseline and months 1-6)
C: Change in Average Pain From Week 1 to Week 5, as Measured by the BPI-SF Average Pain Severity Item (Day 1 of Week 1 to Day 1 of Week 6)
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: Randomized Phase III Trial to Compare Radiation Therapy Alone With Radiation Therapy and Concomitant Anti-EGFr Antibody (C225) for Locally Advanced Squamous Cell Carcinomas of the Head and Neck
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known if radiation therapy is more effective with or without cetuximab for cancer of the oropharynx, hypopharynx, or larynx.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without cetuximab in treating patients who have stage III or stage IV cancer of the oropharynx, hypopharynx, or larynx.


Options:
A: rate of laryngeal preservation
B: 24-month Progression-free Survival (assessed within 14 days after delivery of the third cycle of induction therapy, and 8 weeks and 6 months after completion of concurrent therapy, then every 6 months until progression or until 3 years from study entry)
C: N/A
D: Overall Survival Time (OS) (time from randomization to death or last day known to be alive, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Phase III Trial to Compare Radiation Therapy Alone With Radiation Therapy and Concomitant Anti-EGFr Antibody (C225) for Locally Advanced Squamous Cell Carcinomas of the Head and Neck
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known if radiation therapy is more effective with or without cetuximab for cancer of the oropharynx, hypopharynx, or larynx.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without cetuximab in treating patients who have stage III or stage IV cancer of the oropharynx, hypopharynx, or larynx.


Options:
A: N/A
B: Event free-survival (3 years)
C: N/A
D: Overall Survival (OS) (From date of randomization to date of death (Up to approximately 18 months))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Phase III Trial to Compare Radiation Therapy Alone With Radiation Therapy and Concomitant Anti-EGFr Antibody (C225) for Locally Advanced Squamous Cell Carcinomas of the Head and Neck
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known if radiation therapy is more effective with or without cetuximab for cancer of the oropharynx, hypopharynx, or larynx.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without cetuximab in treating patients who have stage III or stage IV cancer of the oropharynx, hypopharynx, or larynx.


Options:
A: N/A
B: The primary endpoints are comprised of a panel of tumor proteins to be obtained before after administration of the study drugs. (2-3 week preoperative period of drug administration)
C: Disease free survival (3 years)
D: Comparison of the Percentage of Participants With a Complete Response in Each Treatment Arm (12 weeks after the completion of therapy)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: OBJECTIVES: I. Evaluate the safety of ascending doses of CPX administered to adult patients with mild cystic fibrosis.

II. Evaluate the pharmacokinetics of ascending doses of CPX in this patient population.


Options:
A: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 24 (Baseline, Week 16 and 24)
B: Number of Participants With Treatment-Emergent Adverse Events (First administration (Day 1) through Follow-up (Day 43))
C: N/A
D: Safety assessments based on clinical evaluations, laboratory assessments, and adverse events. (28 Days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: OBJECTIVES: I. Evaluate the safety of ascending doses of CPX administered to adult patients with mild cystic fibrosis.

II. Evaluate the pharmacokinetics of ascending doses of CPX in this patient population.


Options:
A: N/A
B: CFTR activity as assessed by nasal transepithelial potential difference (TEPD) (84 days)
C: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
D: Change From Baseline in Total Chloride Transport at Day 14 of Cycles 1 and 2 (Baseline of Cycle 1 and Cycle 2, Day 14 of Cycle 1 and Cycle 2 (1 cycle=28 days)); Number of Participants With a Chloride Transport Response at Day 14 of Cycles 1 and 2 (Day 14 of Cycle 1 and Cycle 2 (1 cycle=28 days)); Number of Participants With Normalization of Chloride Transport Between Baseline and Day 14 of Cycles 1 and 2 (Overall Baseline and Day 14 of Cycle 1 and Cycle 2 (1 cycle=28 days))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Randomized Study of SYNSORB Pk in Children With E. Coli-Associated
Brief Summary: OBJECTIVES: I. Determine the effect of SYNSORB Pk therapy on mortality and frequency of severe extrarenal complications observed in children with acute stage E. coli-associated hemolytic uremic syndrome.

II. Determine the effect of SYNSORB Pk therapy on the need for the duration of dialysis in these patients.

III. Determine the effect of SYNSORB Pk therapy on the recovery of renal function and resolution of urinary abnormalities in these patients.


Options:
A: Time to death or serious extrarenal events (60 days); Time to dialysis (60 days)
B: Safety and Tolerability: Evaluation of number and type of adverse events and serious adverse events between arms and dosage cohorts (Up to 1 year)
C: Number of children enrolled in the study protocol (at the end of the 24 month study recruiting period)
D: Incidence of HUS development (4 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: OBJECTIVES:

I. Determine the safety and efficacy of a short course (72 hours) of intravenous acetylcysteine in patients with acute liver failure for whom no antidote or specific treatment is available.


Options:
A: Overall survival rate (3 weeks)
B: Proportion of patients developing an increase in serum creatinine greater than 25% from baseline to peak level within first five postoperative days.
C: Rise in creatinine above baseline (7 days postoperatively)
D: Absolute change in serum creatinine from baseline to peak level within the first five postoperative days.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: OBJECTIVES: I. Evaluate the efficacy of fluoxetine on social and language deficits, global severity and compulsive dimensions of children and adolescents with autism.

II. Assess the effectiveness of this treatment regimen on neurocognitive deficits in this patient population.

III. Compare the baseline compulsive severity and treatment outcome in these patients.


Options:
A: Efficacy: Behavior assessments (up to 24 hours post-dose); Safety: Incidence of adverse events (up to 24 hours post-dose)
B: N/A
C: Changes in the Autism Diagnostic Observation Schedule (ADOS) (At baseline and after 12 weeks of treatment); Clinical Global Impression Scale (CGI) (At baseline and every 4 week up to 12 weeks)
D: Change in Aberrant Behavior Checklist-Modified Social Withdrawal Subscale ABC-mSW, a Measure of Social Reciprocity (Least Mean Squares Double-blind phase: change from baseline to week 24); Change in Aberrant Behavior Checklist-Modified Social Withdrawal Subscale ABC-mSW, a Measure of Social Reciprocity (Least mean squares for Open Label: Change between weeks 24-48)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: OBJECTIVES: I. Evaluate the efficacy of fluoxetine on social and language deficits, global severity and compulsive dimensions of children and adolescents with autism.

II. Assess the effectiveness of this treatment regimen on neurocognitive deficits in this patient population.

III. Compare the baseline compulsive severity and treatment outcome in these patients.


Options:
A: Change in Aberrant Behavior Checklist (ABC) Irritability Subscale Score at Week 6 (Baseline to 6 Weeks)
B: N/A
C: Clinical Global Impression - Severity (Week 12); Clinical Global Impression - Improvement (Week 12)
D: Changes in the Irritability Subscale of the Larger ABC (Abberent Behavior Checklist) That Occur From Baseline to 10 Weeks (baseline to 10 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: OBJECTIVES: I. Evaluate the efficacy of fluoxetine on social and language deficits, global severity and compulsive dimensions of children and adolescents with autism.

II. Assess the effectiveness of this treatment regimen on neurocognitive deficits in this patient population.

III. Compare the baseline compulsive severity and treatment outcome in these patients.


Options:
A: Change From Baseline in Aberrant Behavior Checklist Irritability Subscale (ABC-I) (Baseline and 7 days.)
B: N/A
C: Number of Participants With Improvement on the Clinical Global Impression-Improvement (CGI-I) Scale (6 Weeks)
D: Mean Conners' Teacher ADHD Index T Score by Dose (Measured at each dosing week of the drug trial (placebo, low, medium, high)); Mean Continuous Performance Test (CPT)-Commission Errors by Dose (Measured at each dosing week of the drug trial (placebo, low, medium, high))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Sertraline for Alcohol Dependence and Depression
Brief Summary: This study will examine depressed alcoholic outpatients to assess whether combining naltrexone (Revia) and sertraline (Zoloft) will result in greater reductions in both drinking and depression over either medication alone or placebo. A secondary aim is to determine whether certain patient features will predict response to sertraline, naltrexone or the combination of the two drugs. Subjects will be randomized into treatment groups for 14 weeks. The followup phase includes two visits at 6 and 9 months after treatment.


Options:
A: The primary outcome measure is remission. It will be evaluated using the Hamilton Depression Rating Scale (HDRS-17 < 8)and Montgomery Asberg Depression Rating Scale (MADRS) (2 to 6 weeks)
B: N/A
C: To determine whether the genetic-brain-cognition function markers (or combination of markers) 'normalise' with acute drug treatment in MDD (Week 8)
D: Subjects self-report of alcohol use, measured by the Timeline Followback (TLFB), and depressive symptoms measured by scores on the Beck Depression Inventory (BDI) and Hamilton Rating Scale for Depression (HRSD). (14 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Occluded Artery Trial (OAT) - Randomized Comparative Effectiveness Trial of PCI and Medical Therapy Only Post MI
Brief Summary: The purpose of this study is to determine whether opening an occluded infarcted artery 3-28 days after an acute myocardial infarction in high-risk asymptomatic patients reduces the composite endpoint of mortality, recurrent myocardial infarction, and hospitalization for class IV congestive heart failure over an average 2.9-year follow-up with extended follow up for an average of six years. Long term follow-up of patients were completed in March 2010. Final collection of all regulatory documentation was completed June 2011.


Options:
A: Primary outcome:time to the first occurrence of stroke, non-CNS systemic embolism, myocardial infarction or vascular death (during approximately three years of follow-up)
B: Number of Patients That Had a First Occurrence of the Primary End Point (Composite of Death From Any Cause, Nonfatal MI, or Class IV HF) (Measured over a maximum 9-year follow-up period - 6 year median)
C: Number of Participants With Surgical Wound Infections From Surgery Through Post-operative Day 90 (90 days post cardiac surgery)
D: death, myocardial infarction or refractory (up to and including Day 9); major bleeding (Up to Day 9)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Cyclophosphamide Versus Placebo in Scleroderma Lung Study
Brief Summary: To evaluate the efficacy and safety of cyclophosphamide versus placebo for the prevention and progression of symptomatic pulmonary disease in patients with systemic sclerosis.


Options:
A: Forced Vital Capacity (FVC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value (Measured at study Baseline and Months 3, 6, 12, 15, 18, 21, and 24)
B: Global Rank Composite Score (GRCS) (Month 54, ITT) (54 Months Post-Randomization)
C: Time to Treatment Failure (12 months); Disease Improvement (12 months)
D: Forced Vital Capacity (12 months)

Answer: D