TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone/Salmeterol Multidose Dry Powder Inhaler in Adolescent and Adult Patients With Persistent Asthma Symptomatic Despite Inhaled Corticosteroid Therapy
Brief Summary: The primary objective of this study was to evaluate the efficacy of fluticasone propionate (Fp) multidose dry powder inhaler (MDPI) and fluticasone propionate/salmeterol xinafoate (FS) MDPI when administered over 12 weeks in patients 12 years of age and older with persistent asthma.


Options:
A: morning peak expiratory flow (PEF) daily measured by patients
B: FEV1 peak0-3 Change From Baseline (Baseline and 24 weeks)
C: Change in evening PEF (Daily throughout the 12 week treatment period)
D: Standardized Baseline-Adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time Zero to 12 Hours PostDose (FEV1 AUEC0-12) at Week 12 (Day 1 (predose, baseline), Week 12 and was performed at the following times relative to the administration of study drug (±5 minutes): 15 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, and 12 hours); Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (Day 1 (predose, baseline), Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone/Salmeterol Multidose Dry Powder Inhaler in Adolescent and Adult Patients With Persistent Asthma Symptomatic Despite Inhaled Corticosteroid Therapy
Brief Summary: The primary objective of this study was to evaluate the efficacy of fluticasone propionate (Fp) multidose dry powder inhaler (MDPI) and fluticasone propionate/salmeterol xinafoate (FS) MDPI when administered over 12 weeks in patients 12 years of age and older with persistent asthma.


Options:
A: Standardized Baseline-Adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time Zero to 12 Hours PostDose (FEV1 AUEC0-12) at Week 12 (Day 1 (predose, baseline), Week 12 and was performed at the following times relative to the administration of study drug (±5 minutes): 15 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, and 12 hours); Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (Day 1 (predose, baseline), Week 12)
B: Percentage of Participants Who Have Either an Asthma Control Test (ACT) Total Score of >=20 or an Increase From Baseline of >=3 in ACT Total Score at Week 24. (Baseline (Day 0) and Week 24)
C: Change From Baseline in Weighted Mean Forced Expiratory Volume in One Second (FEV1) Over 0 to 24 Hours Post-dose at the End of the 12-week Treatment Period (Baseline and Week 12)
D: The Number of All Randomized Subjects Reporting Adverse Events (AEs). (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone/Salmeterol Multidose Dry Powder Inhaler in Adolescent and Adult Patients With Persistent Asthma Symptomatic Despite Inhaled Corticosteroid Therapy
Brief Summary: The primary objective of this study was to evaluate the efficacy of fluticasone propionate (Fp) multidose dry powder inhaler (MDPI) and fluticasone propionate/salmeterol xinafoate (FS) MDPI when administered over 12 weeks in patients 12 years of age and older with persistent asthma.


Options:
A: Asthma exacerbation rate per patient per year
B: For FS MDPI Versus Fp MDPI: Change From Baseline in 1-Hour Postdose Percent Predicted Morning Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (Baseline, Week 12); For Fp MDPI Versus Placebo: Change From Baseline in Weekly Average of the Percent Predicted Trough Morning FEV1 at Week 12 (Baseline, Week 12)
C: Number of Participants Experiencing an Event in the Composite Endpoint (Asthma-related Death, Asthma-related Intubation or Asthma-related Hospitalization) (Up to 27 weeks); Number of Participants Experiencing an Event Included in the Definition of Asthma Exacerbation (Up to 26 weeks)
D: Standardized Baseline-Adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time Zero to 12 Hours PostDose (FEV1 AUEC0-12) at Week 12 (Day 1 (predose, baseline), Week 12 and was performed at the following times relative to the administration of study drug (±5 minutes): 15 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, and 12 hours); Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (Day 1 (predose, baseline), Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a Multi-level Clinic and Family Asthma Intervention With a Randomized Control Trial
Brief Summary: The aim of this group-randomized trial was to test the effectiveness of a new comprehensive program, which the investigators called CALMA -plus, in increasing controller medication use and reducing asthma symptoms. CALMA-plus involved the CALMA home-based family intervention, plus educational training of physicians and nurses, as well as screening for asthma in clinics serving Medicaid island Puerto Rican children with asthma. Because the provider training was expected to have an impact on the entire clinical setting where trained providers work, as well as the patients using that setting, the investigators randomized clinic groups rather than individual patients. The investigators compared the CALMA-Plus intervention to a CALMA-only group, which the investigators expected to obtain the same benefits as the investigators have previously documented.


Options:
A: Safety and toxicity profile: Unacceptable Serious Adverse Events (6 weeks (up to 12 weeks))
B: Change in Percentage of participants using controller medications for asthma from baseline to 12 month follow-up (Baseline, 12)
C: FEV1 peak0-3 Change From Baseline (Baseline and 24 weeks)
D: Airway response to inhaled allergen (at time of allergen inhalation challenge and for 7 hours after)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a Multi-level Clinic and Family Asthma Intervention With a Randomized Control Trial
Brief Summary: The aim of this group-randomized trial was to test the effectiveness of a new comprehensive program, which the investigators called CALMA -plus, in increasing controller medication use and reducing asthma symptoms. CALMA-plus involved the CALMA home-based family intervention, plus educational training of physicians and nurses, as well as screening for asthma in clinics serving Medicaid island Puerto Rican children with asthma. Because the provider training was expected to have an impact on the entire clinical setting where trained providers work, as well as the patients using that setting, the investigators randomized clinic groups rather than individual patients. The investigators compared the CALMA-Plus intervention to a CALMA-only group, which the investigators expected to obtain the same benefits as the investigators have previously documented.


Options:
A: glycemic control (1/2006-3/2009); treatment adherence (1/2006-3/2009)
B: Parent report measures (5 years); Teen self-report measures (5 years)
C: Change in Percentage of participants using controller medications for asthma from baseline to 12 month follow-up (Baseline, 12)
D: ER visits (18 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a Multi-level Clinic and Family Asthma Intervention With a Randomized Control Trial
Brief Summary: The aim of this group-randomized trial was to test the effectiveness of a new comprehensive program, which the investigators called CALMA -plus, in increasing controller medication use and reducing asthma symptoms. CALMA-plus involved the CALMA home-based family intervention, plus educational training of physicians and nurses, as well as screening for asthma in clinics serving Medicaid island Puerto Rican children with asthma. Because the provider training was expected to have an impact on the entire clinical setting where trained providers work, as well as the patients using that setting, the investigators randomized clinic groups rather than individual patients. The investigators compared the CALMA-Plus intervention to a CALMA-only group, which the investigators expected to obtain the same benefits as the investigators have previously documented.


Options:
A: Change in Percentage of participants using controller medications for asthma from baseline to 12 month follow-up (Baseline, 12)
B: Patient Adherence to Inhaled Corticosteroids (ICS) (1 year)
C: Adherence to inhaled corticosteroid medication (12 months)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Diffusion Weighted Imaging (DWI) or Computerized Tomography Perfusion (CTP) Assessment With Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing Neurointervention (DAWN)
Brief Summary: The purpose of the study is to evaluate the hypothesis that Trevo thrombectomy plus medical management leads to superior clinical outcomes at 90 days as compared to medical management alone in appropriately selected subjects experiencing an acute ischemic stroke when treatment is initiated within 6-24 hours after last seen well.


Options:
A: Weighted Modified Rankin Scale (mRS) Score, Lead Co-Primary Efficacy Outcome (90 days); Functional Independence (mRS 0-2), Nested Co-Primary Efficacy Outcome (90 days); Stroke-related Mortality, Primary Safety Outcome (90 days)
B: objective signs of tissue or neurovascular injury (180 days after treatment); levels of plasma biomarkers (180-day)
C: changes in brain lesions (0-24 months)
D: Salvage index (%): Difference in infarct growth (PWI-DWI) after 24 hours among patients treated with preconditioning and those not treated. (February 2012)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Diffusion Weighted Imaging (DWI) or Computerized Tomography Perfusion (CTP) Assessment With Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing Neurointervention (DAWN)
Brief Summary: The purpose of the study is to evaluate the hypothesis that Trevo thrombectomy plus medical management leads to superior clinical outcomes at 90 days as compared to medical management alone in appropriately selected subjects experiencing an acute ischemic stroke when treatment is initiated within 6-24 hours after last seen well.


Options:
A: To assess whether local intra-arterial (LIA) recombinant tissue plasminogen activator rt-PA, as compared to intravenous (IV) rt-PA, increases survival free of disability (modified Rankin score of 0 or 1) . (3 months)
B: Distribution of the modified Rankin Scale scores (shift analysis) (90 days)
C: Weighted Modified Rankin Scale (mRS) Score, Lead Co-Primary Efficacy Outcome (90 days); Functional Independence (mRS 0-2), Nested Co-Primary Efficacy Outcome (90 days); Stroke-related Mortality, Primary Safety Outcome (90 days)
D: Feasibility of enrolling 12 subjects with major vessel occlusion within 1 year and random 1:1 assignment to treatment with IV (N=6) and IA (N=6) IA Activase using the following criteria: Time to clinical and radiological assessments (3 years); Time to IA Activase treatment (3 years); Preliminary safety assessment: 24 hour symptomatic ICH (3 years); Resources utilized and risk-benefit of IA Activase treatment. (3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Diffusion Weighted Imaging (DWI) or Computerized Tomography Perfusion (CTP) Assessment With Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing Neurointervention (DAWN)
Brief Summary: The purpose of the study is to evaluate the hypothesis that Trevo thrombectomy plus medical management leads to superior clinical outcomes at 90 days as compared to medical management alone in appropriately selected subjects experiencing an acute ischemic stroke when treatment is initiated within 6-24 hours after last seen well.


Options:
A: Occurrence of appropriate ICD intervention (shock or antitachycardia pacing) for spontaneous ventricular tachyarrhythmias, or all-cause mortality
B: Weighted Modified Rankin Scale (mRS) Score, Lead Co-Primary Efficacy Outcome (90 days); Functional Independence (mRS 0-2), Nested Co-Primary Efficacy Outcome (90 days); Stroke-related Mortality, Primary Safety Outcome (90 days)
C: Major cardiovascular events, which comprises fatal cardiovascular diseases (CVD), non-fatal myocardial infarction, non-fatal cardiac arrest, non-fatal stroke and cardiac interventions (PCI and CABG) (monitored during intervention)
D: Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect (baseline and 12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Diffusion Weighted Imaging (DWI) or Computerized Tomography Perfusion (CTP) Assessment With Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing Neurointervention (DAWN)
Brief Summary: The purpose of the study is to evaluate the hypothesis that Trevo thrombectomy plus medical management leads to superior clinical outcomes at 90 days as compared to medical management alone in appropriately selected subjects experiencing an acute ischemic stroke when treatment is initiated within 6-24 hours after last seen well.


Options:
A: Randomization potential (20 weeks)
B: Weighted Modified Rankin Scale (mRS) Score, Lead Co-Primary Efficacy Outcome (90 days); Functional Independence (mRS 0-2), Nested Co-Primary Efficacy Outcome (90 days); Stroke-related Mortality, Primary Safety Outcome (90 days)
C: Score on the modified Rankin scale (3 months)
D: modified rankin score（mRS） (post-procedural 90 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Diffusion Weighted Imaging (DWI) or Computerized Tomography Perfusion (CTP) Assessment With Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing Neurointervention (DAWN)
Brief Summary: The purpose of the study is to evaluate the hypothesis that Trevo thrombectomy plus medical management leads to superior clinical outcomes at 90 days as compared to medical management alone in appropriately selected subjects experiencing an acute ischemic stroke when treatment is initiated within 6-24 hours after last seen well.


Options:
A: Weighted Modified Rankin Scale (mRS) Score, Lead Co-Primary Efficacy Outcome (90 days); Functional Independence (mRS 0-2), Nested Co-Primary Efficacy Outcome (90 days); Stroke-related Mortality, Primary Safety Outcome (90 days)
B: Shift in the mRS score, defined by a proportional odds model. (90 days)
C: Feasibility of enrolling 12 subjects with major vessel occlusion within 1 year and random 1:1 assignment to treatment with IV (N=6) and IA (N=6) IA Activase using the following criteria: Time to clinical and radiological assessments (3 years); Time to IA Activase treatment (3 years); Preliminary safety assessment: 24 hour symptomatic ICH (3 years); Resources utilized and risk-benefit of IA Activase treatment. (3 years)
D: Primary Efficacy Endpoint (acute/procedural); Primary Safety Endpoint (within 24 hours of procedure)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Diffusion Weighted Imaging (DWI) or Computerized Tomography Perfusion (CTP) Assessment With Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing Neurointervention (DAWN)
Brief Summary: The purpose of the study is to evaluate the hypothesis that Trevo thrombectomy plus medical management leads to superior clinical outcomes at 90 days as compared to medical management alone in appropriately selected subjects experiencing an acute ischemic stroke when treatment is initiated within 6-24 hours after last seen well.


Options:
A: Cerebral vasospasms: Symptomatic vasospasm defined as documented arterial vasospasm consistent with new neurological deterioration. New low-density areas on CT scans associated with vasospasm. (Between 4 and 30 days after the onset of SAH)
B: Occurrence of appropriate ICD intervention (shock or antitachycardia pacing) for spontaneous ventricular tachyarrhythmias, or all-cause mortality
C: Composite of CV Death, Nonfatal MI (Including Silent MI), Nonfatal Stroke, Coronary Revascularization, or Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization. (Total follow-up time of up to approximately 6 years.)
D: Weighted Modified Rankin Scale (mRS) Score, Lead Co-Primary Efficacy Outcome (90 days); Functional Independence (mRS 0-2), Nested Co-Primary Efficacy Outcome (90 days); Stroke-related Mortality, Primary Safety Outcome (90 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Diffusion Weighted Imaging (DWI) or Computerized Tomography Perfusion (CTP) Assessment With Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing Neurointervention (DAWN)
Brief Summary: The purpose of the study is to evaluate the hypothesis that Trevo thrombectomy plus medical management leads to superior clinical outcomes at 90 days as compared to medical management alone in appropriately selected subjects experiencing an acute ischemic stroke when treatment is initiated within 6-24 hours after last seen well.


Options:
A: Efficacy (90 day after stroke); Safety (90 day after stroke)
B: Rate of Good Functional Outcomes Measured by Modified Rankin Score (mRS) (90 days)
C: Weighted Modified Rankin Scale (mRS) Score, Lead Co-Primary Efficacy Outcome (90 days); Functional Independence (mRS 0-2), Nested Co-Primary Efficacy Outcome (90 days); Stroke-related Mortality, Primary Safety Outcome (90 days)
D: Utility-weighted 90-day Modified Rankin Score (90 days post randomization)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparative Study Between Duct to Mucosa and Invagination Pancreaticojejunostomy After Pancreaticoduodenectomy: A Prospective Randomized Study
Brief Summary: Postoperative pancreatic fistula (POPF) remains a challenge even at specialized centers, and also affect significantly the surgical outcomes . The incidence of POPF after pancreaticoduodenectomy among different studies, ranging from 5 to 30%.Morbidity and mortality after pancreaticoduodenectomy are usually related to surgical management of the pancreatic stump. The safe pancreatic reconstruction after pancreaticoduodenectomy continues to be a challenge at high volume centers. The variety of reconstruction is a reflection of the lack of ideal one.Duct to mucosa and invagination are two classic PJ techniques. Many studies compared both techniques, but their surgical outcomes still unclear.The aim of the study was to assess the effectiveness and surgical outcomes of both techniques of PJ after pancreaticoduodenectomy.


Options:
A: The frequency of pancreatic fistula including ISGPF grade B and C (Ninety days after operation)
B: POPF (up to 30 days)
C: The primary endpoint will be the pancreatic fistula rate. (1 year)
D: the postoperative pancreatic fistula(POPF) rate (30 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Dietary Protein From Meat vs. Dairy on Infant Growth, Body Composition and Gut Health
Brief Summary: Current research shows that dairy protein accelerates infant weight gain, which is a risk factor for later on obesity and metabolic syndrome. However, dietary protein from other sources haven't been studied yet. This longitudinal study will compare two complementary feeding regimens with dietary protein mainly from 1) meat; 2) dairy on infant growth, body composition and gut microbiome from 5 to 12 months of age in formula fed infants. Healthy infants at approximately 5 months of age will be randomized to either a meat protein, or a dairy protein group with complementary protein mainly from meat or dairy. Infants will consume one of these diets for 7 months (6-12 months of age) and infant growth, body composition, growth biomarkers and gut microbiome will be measured to compare between groups and over time.


Options:
A: Linear Growth (6-18 mos of age)
B: Incidence of Stunting of Linear Growth (18 months of age)
C: Change of linear growth (6 months)
D: Linear growth velocity (6 to 18 months of age)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Open-Label Phase III Trial of Pembrolizumab Versus Platinum Based Chemotherapy in 1L Subjects With PD-L1 Strong Metastatic Non-Small Cell Lung Cancer
Brief Summary: This is a study to assess the efficacy and safety of pembrolizumab (MK-3475/SCH 900475) compared to standard of care (SOC) platinum-based chemotherapies in the treatment of participants with previously untreated stage IV, programmed cell death ligand 1 (PD-L1) strong expressing Non-Small Cell Lung Cancer (NSCLC). The primary hypothesis of this study is that participants with PD-L1 strong NSCLC will have a longer Progression Free Survival (PFS), as assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) when treated with pembrolizumab than when treated with SOC platinum-based chemotherapies.

With Amendment 09 (20 December 2017), once participants have achieved the study objective or the study has ended, participants will be discontinued from this study and enrolled in an extension study to continue protocol-defined assessments and treatment.


Options:
A: Overall survival (1-year)
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: Progression Free Survival (PFS), as Determined by the Investigator in Arm B Versus Arm C in the Teff-high WT Population and ITT-WT Population (Baseline until disease progression or death, whichever occurs first until data cut-off on 15 September 2017 (up to approximately 29 months)); Overall Survival (OS) in Arm B Versus Arm C in ITT-WT Population (Baseline until death until data cut-off on 22 January 2018 (up to approximately 34 months)); Overall Survival (OS) in Arm A Versus Arm C in ITT-WT Population (Baseline until death (up approximately 53 months))

Answer: B