TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy (CAT) Regimen of Inhaled Antibiotics for the Treatment of Chronic Pulmonary Pseudomonas Aeruginosa Infection in Subjects With Cystic Fibrosis
Brief Summary: The primary objective of this study is to evaluate the safety and efficacy of a CAT regimen with aztreonam for inhalation solution (AZLI) and tobramycin inhalation solution (TIS) in adult and pediatric subjects with cystic fibrosis (CF) and pulmonary Pseudomonas aeruginosa (PA) infection. Participants will be enrolled in a 28 day TIS run-in phase, and will be eligible for randomization in the comparative phase if they have not received non-study oral antibiotics for a respiratory event, or IV or inhaled antibiotics for any indication between Visits 2 and 3, have not developed a condition requiring hospitalization or other change in clinical status which, in the opinion of the investigator would preclude their ability to continue in the study, and have demonstrated at least 50% TIS compliance. Participants enrolled in the comparative phase will be randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI or placebo for 28 days followed by TIS for 28 days.


Options:
A: Rate of Protocol-defined Exacerbations (PDE) From Baseline Through Week 24 (Baseline in the comparative phase to the end of study (average time on study during the Comparative Phase: 155.4 days))
B: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (From start of study until end of the study (up to 168 days)); Relative Change From Baseline in Percent Predicted Forced Expiratory Volume in One Second (FEV1) (Baseline, day 28)
C: Time to Recurrence of Pseudomonas (P.) Aeruginosa (Any Genotype) in Sputum or Deep Throat Cough Swab (From 1 month after the end of treatment (Day 56 for the 28-day treatment group and Month 3 for the 56-day treatment group) until the end of the study (Month 27))
D: To better define risk factors for first isolation of Pa from respiratory culture, as well as for emergence of mucoid Pa and antibiotic-resistant Pa. (over the two-to-five-year observational period); To better define clinical outcomes associated with acquisition of Pa, as well as outcomes associated with emergence of mucoid Pa and antibiotic-resistant Pa. (over the two-to-five-year observational period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Multicenter, Adaptive Phase II/III Study To Evaluate The Efficacy And Safety Of Trastuzumab Emtansine (T-DM1) Versus Taxane (Docetaxel Or Paclitaxel) In Patients With Previously Treated Locally Advanced Or Metastatic HER2-Positive Gastric Cancer, Including Adenocarcinoma Of The Gastroesophageal Junction
Brief Summary: This multicenter, randomized, adaptive Phase II/III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) compared to standard taxane (docetaxel or paclitaxel) treatment in participants with human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer. At the start of the trial (stage 1), participants will be randomized with a ratio 2:2:1 to one of three treatment arms: Arm A: trastuzumab emtansine 3.6 milligram per kilogram (mg/kg) per intravenous injection (IV) every 3 weeks; Arm B: trastuzumab emtansine 2.4 mg/kg IV every week; Arm C: standard taxane therapy (docetaxel 75 milligram per meter square \[mg/m\^2\] IV every 3 weeks or paclitaxel 80 mg/m\^2 kg IV every week per investigator choice). At the end of the first stage of the study, the dose and schedule of trastuzumab emtansine that will be used in the second stage of the study will be selected by an Independent Data Monitoring Committee (IDMC). The regimen selection analysis will be made after approximately 100 participants across all three study arms have been treated for at least 12 weeks.

Once a trastuzumab emtansine regimen has been selected, Stage I participants who were assigned to the treatment arm which was selected for Stage II of the study and participants who were in the standard taxane group will continue to receive their assigned treatment regimen. Stage I participants who were assigned to the regimen that was not selected for further evaluation will continue to receive their assigned regimen and will continue to be followed for efficacy and safety. In Stage II of the study, additional participants will be recruited and randomized with a ratio 2:1 to either the selected regimen of trastuzumab emtansine or to the standard taxane therapy. Participants will receive study treatment until disease progression, unacceptable toxicity, initiation of another cancer therapy or withdrawal.


Options:
A: Progression-free Survival (Treatment will continue until disease progression or intolerable toxicity, up to 2 years)
B: Failure-free survival (six months)
C: Overall Survival (OS) (From the date of randomization until disease progression or death, cut-off date: 15 August 2014 (approximately 40 months))
D: Overall Survival (OS)- Phase 3 (Date of randomization until death (up to 2 years 3 months)); Overall Survival (OS) - Phase 2 (Dose Selection Portion of the Study) (Date of randomization until death (up to 1 year))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label Randomized Phase III Trial of BMS-936558 (Nivolumab) Versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC)
Brief Summary: The purpose of the study is to compare the overall survival of BMS-936558 as compared with Docetaxel in subjects with squamous cell non-small cell lung cancer (NSCLC), after failure of prior platinum-based chemotherapy.


Options:
A: Progression-Free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the ITT-WT Population (Up to approximately 35 months after first patient enrolled); Overall Survival (OS) in the ITT-WT Population (Up to approximately 35 months after first patient enrolled)
B: Overall Survival (OS) (Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)); Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)); Percentage of Participants Experiencing Adverse Events (AEs) (Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)); Percentage of Participants Discontinuing Study Drug Due to AEs (Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months))
C: Progression Free Survival (PFS) Rate at Month 6 (Month 6)
D: Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint (Randomization until 199 deaths, up to November 2014, approximately 25 months); Overall Survival (OS) Rate in All Randomized Participants (Randomization to 18 months post-randomization, up to June 2015); Number of Deaths From Any Cause in All Randomized Participants at Primary Endpoint (Randomization until 199 deaths, up to November 2014, approximately 25 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label Randomized Phase III Trial of BMS-936558 (Nivolumab) Versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC)
Brief Summary: The purpose of the study is to compare the overall survival of BMS-936558 as compared with Docetaxel in subjects with squamous cell non-small cell lung cancer (NSCLC), after failure of prior platinum-based chemotherapy.


Options:
A: Progression Free Survival (PFS) (18 months)
B: Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint (Randomization until 413 deaths, up to March 2015 (approximately 29 months))
C: Toxicity Rate (Date of patient registration until 6 months after the administration of the last treatment (a maximum of 2 years treatment and 6 months followup after end of treatment)); Durable Clinical Benefit (≥18 weeks, up to maximum of 2 years)
D: Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint (Randomization until 199 deaths, up to November 2014, approximately 25 months); Overall Survival (OS) Rate in All Randomized Participants (Randomization to 18 months post-randomization, up to June 2015); Number of Deaths From Any Cause in All Randomized Participants at Primary Endpoint (Randomization until 199 deaths, up to November 2014, approximately 25 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label Randomized Phase III Trial of BMS-936558 (Nivolumab) Versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC)
Brief Summary: The purpose of the study is to compare the overall survival of BMS-936558 as compared with Docetaxel in subjects with squamous cell non-small cell lung cancer (NSCLC), after failure of prior platinum-based chemotherapy.


Options:
A: Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death (From first dose to 30 days after the last dose of study drug (assessed up to July 2016, approximately 55 months)); Number of Participants Who Experienced Selected Adverse Events (From first dose to 30 days after the last dose of study drug (assessed up to July 2016, approximately 55 months)); Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests (From first dose to 30 days following last dose of study drug (assessed up to July 2016, approximately 55 months)); Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests (From first dose to 30 days following last dose of study drug (assessed up to July 2016, approximately 55 months))
B: Progression Free Survival (PFS) Rate at Month 6 (Month 6)
C: Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint (Randomization until 413 deaths, up to March 2015 (approximately 29 months))
D: Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint (Randomization until 199 deaths, up to November 2014, approximately 25 months); Overall Survival (OS) Rate in All Randomized Participants (Randomization to 18 months post-randomization, up to June 2015); Number of Deaths From Any Cause in All Randomized Participants at Primary Endpoint (Randomization until 199 deaths, up to November 2014, approximately 25 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label Randomized Phase III Trial of BMS-936558 (Nivolumab) Versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC)
Brief Summary: The purpose of the study is to compare the overall survival of BMS-936558 as compared with Docetaxel in subjects with squamous cell non-small cell lung cancer (NSCLC), after failure of prior platinum-based chemotherapy.


Options:
A: Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint (Randomization until 199 deaths, up to November 2014, approximately 25 months); Overall Survival (OS) Rate in All Randomized Participants (Randomization to 18 months post-randomization, up to June 2015); Number of Deaths From Any Cause in All Randomized Participants at Primary Endpoint (Randomization until 199 deaths, up to November 2014, approximately 25 months)
B: Investigator-assessed Objective Progression-free Survival (PFS) (Date of randomization to the date of measured PD or date of death from any cause (up to 19.3 months))
C: Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death (From first dose to 30 days after the last dose of study drug (assessed up to July 2016, approximately 55 months)); Number of Participants Who Experienced Selected Adverse Events (From first dose to 30 days after the last dose of study drug (assessed up to July 2016, approximately 55 months)); Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests (From first dose to 30 days following last dose of study drug (assessed up to July 2016, approximately 55 months)); Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests (From first dose to 30 days following last dose of study drug (assessed up to July 2016, approximately 55 months))
D: Overall Survival (OS) in Participants With a Tumor Proportion Score (TPS) of ≥50% (Up to approximately 44 months); Overall Survival (OS) in Participants With a Tumor Proportion Score (TPS) of ≥20% (Up to approximately 44 months); Overall Survival (OS) in Participants With a Tumor Proportion Score (TPS) of ≥1% (Up to approximately 44 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label Randomized Phase III Trial of BMS-936558 (Nivolumab) Versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC)
Brief Summary: The purpose of the study is to compare the overall survival of BMS-936558 as compared with Docetaxel in subjects with squamous cell non-small cell lung cancer (NSCLC), after failure of prior platinum-based chemotherapy.


Options:
A: Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint (Randomization until 199 deaths, up to November 2014, approximately 25 months); Overall Survival (OS) Rate in All Randomized Participants (Randomization to 18 months post-randomization, up to June 2015); Number of Deaths From Any Cause in All Randomized Participants at Primary Endpoint (Randomization until 199 deaths, up to November 2014, approximately 25 months)
B: N/A
C: Local Regional Control Rate at 2 Years (from study day 1 to 2 years)
D: Local Regional Control Rate at 2 Years (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Oral Budesonide Suspension (OBS) in Adolescent and Adult Subjects (11-40 Years of Age)With Eosinophilic Esophagitis: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study With an Open Label Extension
Brief Summary: This is a clinical trial to test an experimental drug for the treatment of Eosinophilic Esophagitis (EoE)


Options:
A: Tissue Eosinophil Counts (8 weeks)
B: Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤6 Eosinophils Per High-power Field (Eos/Hpf) in All Three Regions at Week 24 (At week 24); Absolute Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Total Score at Week 24 (Baseline and week 24)
C: Percent of Participants Who Were Histologic Responders (Week 16); Change From Baseline in The Dysphagia Symptom Questionnaire (DSQ) Score at The Final Treatment Period Evaluation (Baseline, Week 16)
D: 1. Reduction of eosinophils in the oesophagus 2. Safety and tolerability of mepolizumab

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Investigation of Motivational Interviewing and Prevention Consults to Achieve Cardiovascular Targets
Brief Summary: The objective of IMPACT (Investigation of Motivational Interviewing and Prevention Consults to Achieve Cardiovascular Targets) is to determine the best management strategy for patients undergoing cardiovascular intervention. IMPACT is a prospective randomized trial that will enroll 400 patients post-cardiovascular intervention. The study will compare different cardiovascular prevention strategies: (1) usual care, (2) cardiovascular prevention consult, and (3) cardiovascular prevention consult with a behavioral intervention program over a 6-month period. The trial hypothesis is that for patients undergoing a cardiovascular intervention, a prevention consult and behavioral intervention is superior to usual care in reducing cardiovascular risk. The primary endpoint will be non-HDL cholesterol. Secondary endpoints include other lipid values, metabolic risk, smoking cessation, physical activity, nutritional status, medication adherence and quality of life. IMPACT is scheduled to begin enrollment in the June of 2012.


Options:
A: Reduction of Non-HDL cholesterol (6 months)
B: Smoking Cue Reactivity on Quit Day (4-weeks)
C: Self-reported prolonged abstinence and cotinine-validated point-prevalence abstinence at 1 year follow-up (1 year)
D: Prolonged abstinence from all tobacco (3 months and 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Investigation of Motivational Interviewing and Prevention Consults to Achieve Cardiovascular Targets
Brief Summary: The objective of IMPACT (Investigation of Motivational Interviewing and Prevention Consults to Achieve Cardiovascular Targets) is to determine the best management strategy for patients undergoing cardiovascular intervention. IMPACT is a prospective randomized trial that will enroll 400 patients post-cardiovascular intervention. The study will compare different cardiovascular prevention strategies: (1) usual care, (2) cardiovascular prevention consult, and (3) cardiovascular prevention consult with a behavioral intervention program over a 6-month period. The trial hypothesis is that for patients undergoing a cardiovascular intervention, a prevention consult and behavioral intervention is superior to usual care in reducing cardiovascular risk. The primary endpoint will be non-HDL cholesterol. Secondary endpoints include other lipid values, metabolic risk, smoking cessation, physical activity, nutritional status, medication adherence and quality of life. IMPACT is scheduled to begin enrollment in the June of 2012.


Options:
A: Change in systolic blood pressure (12-months from baseline)
B: Reduction of Non-HDL cholesterol (6 months)
C: medication adherence (one month)
D: Brain Natriuretic Peptide values (Baseline, 6 months); Self-care practices measured through Self-Care of Heart Failure Index scores and interviews (baseline, 6 months); Health related quality of life measured through the Minnesota Living with Heart Failure Questionnaire scores and interviews (baseline, 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinic, Family & Community Collaboration to Treat Overweight and Obese Children
Brief Summary: Stanford GOALS is a large-scale, community-based randomized controlled trial of an innovative, interdisciplinary, multi-component, multi-level, multi-setting (MMM) approach to treating overweight and obese children. Primary Research Question: Will a 3-year, innovative, interdisciplinary, multi-component, multi-level, multi-setting (MMM) community-based intervention to treat overweight and obese children significantly reduce BMI compared to an enhanced standard care/health and nutrition education active comparison intervention?


Options:
A: Event-related brain potentials (Change from baseline, 36-40 weeks); Task Performance (Change from baseline, 36-40 weeks); Academic Achievement (Change from baseline, 36-40 weeks)
B: body mass index trajectory (change) (baseline, 1, 2 and 3 years)
C: Changes in Brain function and structure using magnetic resonance imaging (MRI) (20 days during baselines and Post-evaluations (after intervention).); Brain and cognitive functioning assessment by electroencephalogram (EEG) (20 days during baselines and Post-evaluations (after intervention).); Cognitive performance (DKEFS test battery) (20 days during baselines and Post-evaluations (after intervention).); Academic achievement (20 days during baselines and Post-evaluations (after intervention).)
D: BMI will be assessed during lifestyle intervention in (1) children and adolescents and (2) adults vs. placebo (21 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinic, Family & Community Collaboration to Treat Overweight and Obese Children
Brief Summary: Stanford GOALS is a large-scale, community-based randomized controlled trial of an innovative, interdisciplinary, multi-component, multi-level, multi-setting (MMM) approach to treating overweight and obese children. Primary Research Question: Will a 3-year, innovative, interdisciplinary, multi-component, multi-level, multi-setting (MMM) community-based intervention to treat overweight and obese children significantly reduce BMI compared to an enhanced standard care/health and nutrition education active comparison intervention?


Options:
A: Our outcome measure was reduction of screen time (4 waves of data)
B: Change in BMI From Baseline to 12 Months Follow up. (Assessed on 2 occasions: 1) Baseline measurements: 4 - 6 weeks before initiation of interventions. 2) 2nd follow up: 52-53 weeks (12 months) after initiation of interventions.)
C: body mass index trajectory (change) (baseline, 1, 2 and 3 years)
D: Area Under the Curve (niAUC) of Perceived Hunger, Fullness, Desire to Eat, and Prospective Food Consumption (5 weeks); Area Under the Curve (AUC) of Plasma Total Ghrelin and Ln Peptide YY (PYY) (5 weeks); Brain Regions Displaying Differential Activation Prior to Dinner in Response to Food vs Nonfood Stimuli From Food Cue-stimulate fMRI Brain Scans (5 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Trial in Subjects Suspected to Have Tuberculosis, Comparing the Diagnostic Performance of C-Tb to QuantiFERON®-TB Gold In-Tube, in Combination With a Double Blind Randomized Split Body Safety Assessment of C-Tb Versus 2 T.U. Tuberculin PPD RT23 SSI (PPD)
Brief Summary: Tuberculosis (TB) continues to be one of the most serious bacterial infections worldwide and therefore new improved diagnostic tests are needed to help doctors in diagnosing TB.

The new skin test is named C-Tb. Like the current tuberculin skin test, PPD, the C-Tb test is injected just under the skin and will, when positive, show redness and/or swelling at the injection site while a negative test will leave no reactions. The investigators hope that this new C-Tb skin test will be more precise (specific) than the PPD test, as the PPD test e.g. may show a reaction if the person tested is BCG vaccinated.

The aim of this trial is to test the C-Tb skin test in volunteers suspected of having TB disease.

With focus on age, HIV status and CD4 count the following analyses are done (in an overall perspective):

* To compare the C-Tb test to a blood test, the QuantiFERON test.
* To compare the C-Tb test to the PPD test that is currently being used.
* To assess the safety of the C-Tb test.


Options:
A: To evaluate the diagnostic performance of C-Tb in relation to age, HIV and CD4 counts (Onset between the injections and 28 days after the injections); To evaluate the clinical safety of C-Tb, with emphasis on children and HIV positive participants (Onset between the injections and 28 days after the injections)
B: To compare the size of induration of C-Tb and PPD RT 23 if injected alone or concomitantly in Tuberculosis infected patients (HIV positives and HIV negatives) (Onset from the injection(s) to 28 days after the injections); To assess if concomitant injections of C-Tb and PPD RT 23 influence the tests abilities to identify positive results of Tuberculosis in Tuberculosis infected patients (Onset from the injection(s) to 28 days after the injections)
C: Treatment Initiation Ratio in Facility Versus Contact Investigation Clinics (18 months); Comparative Treatment Initiation Ratio in the Incentive-based Versus Household-based Contact Investigation Arms (36 months)
D: Tuberculosis diagnostic algorithm (3 years)

Answer: A