TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Multicenter Study Comparing MDX-010 Monotherapy, MDX-010 in Combination With a Melanoma Peptide Vaccine, and Melanoma Vaccine Monotherapy in HLA-A2*0201-Positive Patients With Previously Treated Unresectable Stage III or IV Melanoma
Brief Summary: The purpose of this study is to determine the safety and efficacy of MDX-010 (ipilimumab, BMS-734016) (anti-CTLA4) in combination with MDX-1379 (gp100, BMS-734019) in patients with previously treated, unresectable Stage III or IV melanoma. Survival time will be evaluated, as well as patient responses and time to disease progression. Eligible patients are those who in response to a single regimen containing interleukin-2 (IL-2), dacarbazine, and/or temozolomide, have 1) relapsed following an objective response (partial response/complete response \[PR/CR\]); 2) failed to demonstrate an objective response (PR/CR); or 3) could not tolerate such a regimen due to unacceptable toxicity. Patients will be randomized into one of three groups, and will receive one of the following treatments: MDX-010 alone, MDX-1379 alone, or MDX-010 in combination with MDX-1379.


Options:
A: Sensitivity and Specificity (Within 120 days of Data Lock)
B: Objective Response Rate (ORR) - BRAF Wild-type (WT) Participants (From 12 weeks after Randomization, assessed every 6 weeks up to Week 49 of study treatment and then every 12 weeks until disease progression (up to approximately 76 months))
C: Progression-free Survival (Baseline to the 21 July 2019 data cut-off (up to 7 years, 6 months))
D: Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 in Combination With gp 100 Melanoma Peptide Vaccine Versus gp 100 Melanoma Peptide Vaccine Alone (From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Multicenter Study Comparing MDX-010 Monotherapy, MDX-010 in Combination With a Melanoma Peptide Vaccine, and Melanoma Vaccine Monotherapy in HLA-A2*0201-Positive Patients With Previously Treated Unresectable Stage III or IV Melanoma
Brief Summary: The purpose of this study is to determine the safety and efficacy of MDX-010 (ipilimumab, BMS-734016) (anti-CTLA4) in combination with MDX-1379 (gp100, BMS-734019) in patients with previously treated, unresectable Stage III or IV melanoma. Survival time will be evaluated, as well as patient responses and time to disease progression. Eligible patients are those who in response to a single regimen containing interleukin-2 (IL-2), dacarbazine, and/or temozolomide, have 1) relapsed following an objective response (partial response/complete response \[PR/CR\]); 2) failed to demonstrate an objective response (PR/CR); or 3) could not tolerate such a regimen due to unacceptable toxicity. Patients will be randomized into one of three groups, and will receive one of the following treatments: MDX-010 alone, MDX-1379 alone, or MDX-010 in combination with MDX-1379.


Options:
A: Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 in Combination With gp 100 Melanoma Peptide Vaccine Versus gp 100 Melanoma Peptide Vaccine Alone (From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks))
B: Pathological response rate (From baseline to 6 weeks)
C: The primary endpoint is the margin of resection. Success is defined by an extralesional excision as from the first surgical procedure performed with a healthy tissue margin of 5 mm. (10 weeks)
D: Progression-free Survival in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases as Assessed by the Investigator and Independent Review (Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Multicenter Study Comparing MDX-010 Monotherapy, MDX-010 in Combination With a Melanoma Peptide Vaccine, and Melanoma Vaccine Monotherapy in HLA-A2*0201-Positive Patients With Previously Treated Unresectable Stage III or IV Melanoma
Brief Summary: The purpose of this study is to determine the safety and efficacy of MDX-010 (ipilimumab, BMS-734016) (anti-CTLA4) in combination with MDX-1379 (gp100, BMS-734019) in patients with previously treated, unresectable Stage III or IV melanoma. Survival time will be evaluated, as well as patient responses and time to disease progression. Eligible patients are those who in response to a single regimen containing interleukin-2 (IL-2), dacarbazine, and/or temozolomide, have 1) relapsed following an objective response (partial response/complete response \[PR/CR\]); 2) failed to demonstrate an objective response (PR/CR); or 3) could not tolerate such a regimen due to unacceptable toxicity. Patients will be randomized into one of three groups, and will receive one of the following treatments: MDX-010 alone, MDX-1379 alone, or MDX-010 in combination with MDX-1379.


Options:
A: Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 in Combination With gp 100 Melanoma Peptide Vaccine Versus gp 100 Melanoma Peptide Vaccine Alone (From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks))
B: Overall survival (Evaluated at regular intervals: every 3 months for 2 years, every 6 months up to 5 years and yearly up to 10 years following randomization. Actual median follow-up is 72.4 months)
C: distant-metastasis free-survival (DMFS) (from randomization)
D: Overall Survival (From randomization (initiated January 2010) to December 30 2010. Median follow-up time in the vemurafenib group was 3.75 months (range 0.3 to 10.8) and in the dacarbazine group was 2.33 months (range <0.1 to 10.3).); Progression-free Survival (From randomization (initiated January 2010) to December 30 2010.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Evaluation of Treatment of Amblyopia in 7 To <18 Year Olds
Brief Summary: The goals of this study are:

* To determine the response rate of treatment of amblyopia in 7 to \<18 year olds.
* To determine the frequency of recurrence of amblyopia in 7 to \<18 year olds after discontinuation of amblyopia treatment.


Options:
A: Change from baseline in visual acuity (6 weeks)
B: Visual acuity improvement
C: Mean Change in Amblyopic-eye Visual Acuity (VA) Older Cohort (Baseline and 4 weeks); Mean Visual Acuity (VA) in Amblyopic-eye (Older Cohort) (4 weeks); Mean Change in Amblyopic-eye Visual Acuity (VA) in Older Cohort (Baseline and 8 weeks); Mean Visual Acuity (VA) in Amblyopic-eye (Older Cohort) (8 weeks); Mean Change in Amblyopic-eye Visual Acuity (VA) Younger Cohort (baseline and 4 weeks); Mean Visual Acuity (VA) in Amblyopic-eye (Younger Cohort) (4 weeks); Mean Change in Amblyopic-eye Visual Acuity (VA) in Younger Cohort (Baseline and 8 weeks); Mean Visual Acuity (VA) in Amblyopic-eye (Younger Cohort) (8 weeks)
D: Best Corrected Visual Acuity, Stereopsis (30 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Evaluation of Treatment of Amblyopia in 7 To <18 Year Olds
Brief Summary: The goals of this study are:

* To determine the response rate of treatment of amblyopia in 7 to \<18 year olds.
* To determine the frequency of recurrence of amblyopia in 7 to \<18 year olds after discontinuation of amblyopia treatment.


Options:
A: Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks (17 weeks); Mean Visual Acuity in the Amblyopic Eye at 17 Weeks (17 weeks); Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks (Baseline to 17 weeks); Mean Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks (Baseline to 17 weeks)
B: maximal improvement in visual acuity
C: Visual acuity improvement
D: The primary outcome measure was logMAR visual acuity, measured 6-weekly for 18 weeks in refractive adaptation phase. In occlusion phase measured 2-weekly until no further gains

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Evaluation of Treatment of Amblyopia in 7 To <18 Year Olds
Brief Summary: The goals of this study are:

* To determine the response rate of treatment of amblyopia in 7 to \<18 year olds.
* To determine the frequency of recurrence of amblyopia in 7 to \<18 year olds after discontinuation of amblyopia treatment.


Options:
A: Distribution of Amblyopic Eye Visual Acuity at 10 Weeks (10 Weeks); Mean (SD) Distribution of Visual Acuity at 10 Weeks (10 Weeks); Distribution of Amblyopic Eye Visual Acuity Change From Baseline to 10 Weeks (baseline to 10 Weeks); Mean (SD) Change in Visual Acuity in the Amblyopic Eye at the 10 Week Primary Outcome Exam (baseline to 10 Weeks)
B: Visual acuity improvement
C: Visual acuity in the amblyopic eye (6 months)
D: Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks (17 weeks); Mean Visual Acuity in the Amblyopic Eye at 17 Weeks (17 weeks); Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks (Baseline to 17 weeks); Mean Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks (Baseline to 17 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Evaluation of Treatment of Amblyopia in 7 To <18 Year Olds
Brief Summary: The goals of this study are:

* To determine the response rate of treatment of amblyopia in 7 to \<18 year olds.
* To determine the frequency of recurrence of amblyopia in 7 to \<18 year olds after discontinuation of amblyopia treatment.


Options:
A: maximal improvement in visual acuity
B: The change of visual acuity from baseline to week six post randomisation visit between the two arms in each group. (6 weeks)
C: Visual acuity improvement
D: Visual acuity (8 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Everyday Memory in At-Risk Elderly
Brief Summary: The purpose of this study is to determine whether classes on memory training will help older adults to improve or maintain their daily activities.


Options:
A: Quality of life (Participants will be followed over 8 weeks)
B: Cognitive-psychosocial functions (3 and 6 months)
C: Fatigue as measured by the Brief Fatigue Inventory (prior to beginning of treatment and after treatment ends. Up to an average of 44 weeks.)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of MK0431 Compared With Sulfonylurea Therapy in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy
Brief Summary: The purpose of this investigational study is to determine the safety and effectiveness of an investigational drug in patients with type 2 diabetes mellitus (a specific type of diabetes).


Options:
A: Change From Baseline in Hemoglobin A1C (A1C) at Week 52: Excluding Rescue Approach (Baseline and Week 52); Percentage of Participants Experiencing An Adverse Event (AE) Up to Week 106 (Up to Week 106); Percentage of Participants Discontinuing Study Treatment Due to an AE Up to Week 104 (Up to Week 104)
B: Change From Baseline in HbA1c at Week 52 (Baseline and Week 52)
C: HbA1c Change From Baseline at Week 18 (Interim Analysis) (Baseline and week 18); HbA1c Change From Baseline at Week 18 (Final Analysis) (Baseline and week 18)
D: Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 104 (Baseline and Week 104)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind Study Comparing Adjunctive Risperidone Versus Placebo in Major Depressive Disorder That Is Not Responding to Standard Therapy
Brief Summary: The purpose of this trial is to evaluate the efficacy and safety of risperidone versus placebo in subjects with Major Depressive Disorder with sub-optimal response to antidepressant therapy.


Options:
A: Difference in therapeutic effect of risperidone and placebo as measured by change in depression rating scale (HAM-D) at end of week 4 of the double-blind phase.
B: Observer-rated depression severity (PHQ-9) (9 weeks)
C: Montgomery-Asberg Depression Rating Scale (MADRS) (Baseline (Week 8) to Week 16)
D: Percentage of Subjects Who Met Criteria for Remission Based on the Montgomery-Asberg Depression Rating Scale (MADRS) (12 weeks); Akathisia (12 weeks); Weight (Baseline through12 weeks); Parkinsonism (12weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve)
Brief Summary: The purpose of this clinical research study is to learn if Irbesartan is superior to placebo in reducing mortality and cardiovascular morbidity in subjects with heart failure with preserved systolic function. The safety of this treatment will also be studied.


Options:
A: The First Occurrence of the Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non Fatal Stroke, or Hospitalization for Heart Failure. (From randomization up until the first occurrence of the CV composite endpoint, or censoring at the end of the study, with an average study duration of 41 months.)
B: Percentage of Participants With First Occurrence of the Composite Outcome of Death (All Cause) or Protocol-Specified Cardiovascular (CV) Hospitalization at Given Timepoints (Year 1, Year 2, Year 3, Year 4, Year 5)
C: Change of of Systolic Blood Pressure (4 months); Change of Diastolic Blood Pressure (4 months)
D: Proteinuria reduction (bi-monthly)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind Trial in Ventilated ICU Patients Comparing Treatment With an Alpha2 Agonist Versus a Gamma Aminobutyric Acid (GABA)-Agonist to Determine Delirium Rates, Efficacy of Sedation, Analgesia and Discharge Cognitive Status
Brief Summary: Delirium has recently been shown as a predictor of death, increased cost, and longer length of stay in ventilated patients. Sedative and analgesic medications relieve anxiety and pain, but may contribute to patients' transitioning into delirium. It is possible that modifying the paradigm for sedation using novel therapies targeted at different receptors, such as dexmedetomidine targeting alpha2 receptors and sparing the GABA receptors, could provide efficacious sedation yet reduce the development, duration, and severity of acute brain dysfunction (delirium).


Options:
A: achieving target sedation level (Patients will receive study drug for a maximum of 120 hours (5 days))
B: Time from the commencement of treatment to extubation (days)
C: The percentage of time spent within the protocol specified sedation range (Richmond Agitation-Sedation Scale [RASS] range of -2 to +1) (Preinfusion, Treatment period: every 10min for 30min, 1 & 4 hr after infusion starts, every 4 hrs, prior to end of infusion & extubation. Follow-up Period (48hrs): every 10min for 1st 30min after drug discontinuation, 1, 4, 8,12, 24 & 48 hr post infusion)
D: Number of patients returning to independent functional status: defined as ability to perform 6 activities of daily living (ADL's)(bathing, dressing, eating, grooming, transfer from bed to chair, toileting) and independent ambulation (Hospital Discharge)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind Trial in Ventilated ICU Patients Comparing Treatment With an Alpha2 Agonist Versus a Gamma Aminobutyric Acid (GABA)-Agonist to Determine Delirium Rates, Efficacy of Sedation, Analgesia and Discharge Cognitive Status
Brief Summary: Delirium has recently been shown as a predictor of death, increased cost, and longer length of stay in ventilated patients. Sedative and analgesic medications relieve anxiety and pain, but may contribute to patients' transitioning into delirium. It is possible that modifying the paradigm for sedation using novel therapies targeted at different receptors, such as dexmedetomidine targeting alpha2 receptors and sparing the GABA receptors, could provide efficacious sedation yet reduce the development, duration, and severity of acute brain dysfunction (delirium).


Options:
A: Duration of Ventilation
B: Length of weaning from mechanical ventilation that corresponds to the time from Time 0 to the first extubation. (first extubation or 28 days)
C: All-cause Mortality (At day 28 after the beginning of mechanical ventilation)
D: achieving target sedation level (Patients will receive study drug for a maximum of 120 hours (5 days))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind Trial in Ventilated ICU Patients Comparing Treatment With an Alpha2 Agonist Versus a Gamma Aminobutyric Acid (GABA)-Agonist to Determine Delirium Rates, Efficacy of Sedation, Analgesia and Discharge Cognitive Status
Brief Summary: Delirium has recently been shown as a predictor of death, increased cost, and longer length of stay in ventilated patients. Sedative and analgesic medications relieve anxiety and pain, but may contribute to patients' transitioning into delirium. It is possible that modifying the paradigm for sedation using novel therapies targeted at different receptors, such as dexmedetomidine targeting alpha2 receptors and sparing the GABA receptors, could provide efficacious sedation yet reduce the development, duration, and severity of acute brain dysfunction (delirium).


Options:
A: Number of Patients With Incidence of Delirium Across All Patients at Baseline and Over Post-operative Days 1-3 (Delirium incidence on postoperative days 1-3, calculated by any positive CAM on any day for all patients)
B: achieving target sedation level (Patients will receive study drug for a maximum of 120 hours (5 days))
C: We will use a composite endpoint by these two instruments: Clinical Dementia Rating Scale (CDR), and the 10 words memory task from the Consortium to Establish a Registry for Alzheimer's Disease battery (CERAD) (4 and 12 months)
D: incidence of delirium (days in hospital)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind Trial in Ventilated ICU Patients Comparing Treatment With an Alpha2 Agonist Versus a Gamma Aminobutyric Acid (GABA)-Agonist to Determine Delirium Rates, Efficacy of Sedation, Analgesia and Discharge Cognitive Status
Brief Summary: Delirium has recently been shown as a predictor of death, increased cost, and longer length of stay in ventilated patients. Sedative and analgesic medications relieve anxiety and pain, but may contribute to patients' transitioning into delirium. It is possible that modifying the paradigm for sedation using novel therapies targeted at different receptors, such as dexmedetomidine targeting alpha2 receptors and sparing the GABA receptors, could provide efficacious sedation yet reduce the development, duration, and severity of acute brain dysfunction (delirium).


Options:
A: Number of patients returning to independent functional status: defined as ability to perform 6 activities of daily living (ADL's)(bathing, dressing, eating, grooming, transfer from bed to chair, toileting) and independent ambulation (Hospital Discharge)
B: All cause mortality (28-day)
C: achieving target sedation level (Patients will receive study drug for a maximum of 120 hours (5 days))
D: delirium (during admission at the critical care)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind Trial in Ventilated ICU Patients Comparing Treatment With an Alpha2 Agonist Versus a Gamma Aminobutyric Acid (GABA)-Agonist to Determine Delirium Rates, Efficacy of Sedation, Analgesia and Discharge Cognitive Status
Brief Summary: Delirium has recently been shown as a predictor of death, increased cost, and longer length of stay in ventilated patients. Sedative and analgesic medications relieve anxiety and pain, but may contribute to patients' transitioning into delirium. It is possible that modifying the paradigm for sedation using novel therapies targeted at different receptors, such as dexmedetomidine targeting alpha2 receptors and sparing the GABA receptors, could provide efficacious sedation yet reduce the development, duration, and severity of acute brain dysfunction (delirium).


Options:
A: Ventilator free days
B: Length of mechanical ventilation and ICU stay. Mortality
C: Duration of Mechanical Ventilation; ICU and Hospital Lengths of stay
D: achieving target sedation level (Patients will receive study drug for a maximum of 120 hours (5 days))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind Trial in Ventilated ICU Patients Comparing Treatment With an Alpha2 Agonist Versus a Gamma Aminobutyric Acid (GABA)-Agonist to Determine Delirium Rates, Efficacy of Sedation, Analgesia and Discharge Cognitive Status
Brief Summary: Delirium has recently been shown as a predictor of death, increased cost, and longer length of stay in ventilated patients. Sedative and analgesic medications relieve anxiety and pain, but may contribute to patients' transitioning into delirium. It is possible that modifying the paradigm for sedation using novel therapies targeted at different receptors, such as dexmedetomidine targeting alpha2 receptors and sparing the GABA receptors, could provide efficacious sedation yet reduce the development, duration, and severity of acute brain dysfunction (delirium).


Options:
A: achieving target sedation level (Patients will receive study drug for a maximum of 120 hours (5 days))
B: Ventilator free days
C: Time From Study Drug Initiation to Tracheal Extubation (Duration of ICU stay, for up to 24 weeks)
D: Depth of sedation using the RASS. The target RASS range (target depth of sedation) should be 0 to -3 for a patient to be included in the study. The target may be amended during the study treatment, if clinically required. (2 hourly and before each rescue treatment dose during the treatment period and the 48-hour follow-up); Duration of mechanical ventilation (Start and stop times of mechanical ventilation while the patient is treated in the ICU)

Answer: A