TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of Subcutaneous Injections of ABT-874 vs. Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Brief Summary: The purpose of the study is to assess the safety and efficacy of ABT-874 in the treatment of moderate to severe chronic plaque psoriasis.


Options:
A: Percentage of Participants Achieving a 75% Reduction in the Psoriasis Area and Severity Index (PASI75) at Week 12 (Week 12); Percentage of Participants Achieving a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12 (Week 12)
B: Core Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in Psoriasis Area and Severity Index (PASI) at Week 16 (Week 0 and Week 16)
C: Proportion of subjects with clinical response relative to Baseline PASI score (Week 12, Week 40 and Week 60)
D: The changes in the target (atherosclerotic plaque) to background (blood) ratio (TBR) from the carotid artery and ascending aorta in patients randomized to adalimumab as compared to patients randomized to standard non-systemic therapy. (Day -10 to -1, Day 105)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of Subcutaneous Injections of ABT-874 vs. Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Brief Summary: The purpose of the study is to assess the safety and efficacy of ABT-874 in the treatment of moderate to severe chronic plaque psoriasis.


Options:
A: Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) (Week 16)
B: Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16 (Baseline and Week 16)
C: N/A
D: Proportion of subjects with clinical response relative to Baseline PASI score (Week 12, Week 40 and Week 60)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of Subcutaneous Injections of ABT-874 vs. Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Brief Summary: The purpose of the study is to assess the safety and efficacy of ABT-874 in the treatment of moderate to severe chronic plaque psoriasis.


Options:
A: Part B: PASI (Psoriasis Area and Severity Index) Score Mean Percentage of Change Through Day 43 (Through day 43); Part B: All Treatment Adverse Events Reported for Safety Evaluation (85 days); Part A: All Treatment Adverse Events Reported for Safety Evaluation (Cohort 1-4 43 days, Cohort 5-8 64 days)
B: Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4 (Baseline, Week 4)
C: Proportion of subjects who achieve a PGA of 0 or 1 response relative to baseline at Week 12 (12 Weeks); Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 12 (12 Weeks)
D: Proportion of subjects with clinical response relative to Baseline PASI score (Week 12, Week 40 and Week 60)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of Subcutaneous Injections of ABT-874 vs. Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Brief Summary: The purpose of the study is to assess the safety and efficacy of ABT-874 in the treatment of moderate to severe chronic plaque psoriasis.


Options:
A: Number of Patients Achieving "Clear" or "Almost Clear" on Physician Global Assessment (PGA) of Psoriasis (12 weeks)
B: The Number of Visits at Which Participants Achieved a Static Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) (Up to 24 weeks (Week 88 up to Week 112 [total 7 visits]))
C: Number of Participants Achieving Static Physician Global Assessment (sPGA) of Genitalia (0,1) (Week 12)
D: Proportion of subjects with clinical response relative to Baseline PASI score (Week 12, Week 40 and Week 60)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre 3 Year Longitudinal Prospective Study to Identify Novel Endpoints and Compare These With Forced Expiratory Volume in 1 Second (FEV1) for Their Ability to Measure and Predict COPD Severity and Its Progression Over Time
Brief Summary: This is a 3 year longitudinal study to identify novel endpoints and compare these with standard measures such as forced expiratory volume in 1 second (FEV1) for their ability to measure and predict COPD (Chronic Obstructive Pulmonary Disease) severity and its progression over time. Control subjects (smokers and never smokers) will be recruited as comparators with the COPD subjects.


Options:
A: Moderate and severe COPD exacerbation rate over 52 weeks of treatment (1 year)
B: Mean Change From Baseline in Post-dose Trough FEV1 (Baseline, 26 weeks)
C: Identifying new patient subtypes and endpoints for COPD (3 years)
D: Adjusted Rate of Moderate or Severe Exacerbations (52-week treatment period)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre 3 Year Longitudinal Prospective Study to Identify Novel Endpoints and Compare These With Forced Expiratory Volume in 1 Second (FEV1) for Their Ability to Measure and Predict COPD Severity and Its Progression Over Time
Brief Summary: This is a 3 year longitudinal study to identify novel endpoints and compare these with standard measures such as forced expiratory volume in 1 second (FEV1) for their ability to measure and predict COPD (Chronic Obstructive Pulmonary Disease) severity and its progression over time. Control subjects (smokers and never smokers) will be recruited as comparators with the COPD subjects.


Options:
A: Percentage of Patients to Experience at Least One Treatment-emergent Adverse Event (TEAE) (Up to study Week 56 ± 3 days)
B: Peak Forced Expiratory Volume in One Second (FEV1) at Week 24 (At Week 24)
C: Percentage of Patients to Experience Any Treatment-emergent Adverse Event (Baseline of lead-in study to follow-up call 14±3 days after last dose of investigational product (up to Week 52))
D: Identifying new patient subtypes and endpoints for COPD (3 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre 3 Year Longitudinal Prospective Study to Identify Novel Endpoints and Compare These With Forced Expiratory Volume in 1 Second (FEV1) for Their Ability to Measure and Predict COPD Severity and Its Progression Over Time
Brief Summary: This is a 3 year longitudinal study to identify novel endpoints and compare these with standard measures such as forced expiratory volume in 1 second (FEV1) for their ability to measure and predict COPD (Chronic Obstructive Pulmonary Disease) severity and its progression over time. Control subjects (smokers and never smokers) will be recruited as comparators with the COPD subjects.


Options:
A: Treatment failure defined as: death from any cause; admission to the intensive care unit; readmission to the hospital because of COPD; and the necessity to intensify pharmacologic treatment
B: Identifying new patient subtypes and endpoints for COPD (3 years)
C: Baseline Pre-bronchodilator FEV1 (L) (Day 1); End-value Pre-bronchodilator FEV1 (L) (up to week 12)
D: Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment (Baseline and Week 24); Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 12 on Treatment (Baseline and Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre 3 Year Longitudinal Prospective Study to Identify Novel Endpoints and Compare These With Forced Expiratory Volume in 1 Second (FEV1) for Their Ability to Measure and Predict COPD Severity and Its Progression Over Time
Brief Summary: This is a 3 year longitudinal study to identify novel endpoints and compare these with standard measures such as forced expiratory volume in 1 second (FEV1) for their ability to measure and predict COPD (Chronic Obstructive Pulmonary Disease) severity and its progression over time. Control subjects (smokers and never smokers) will be recruited as comparators with the COPD subjects.


Options:
A: All cause mortality at 3 years
B: lung oxygenation (over a period of 6-8 hours, from the time of induction of general anesthesia until time of patients discharge from the PACU.)
C: Measurements of forced vital capacity (FVC), forced expiratory volume (FEV1), functional residual capacity (FRC),maximal respiratory pressures,maximal oxygen consumption and maximal work load. (Immediatly after the end of IV infusion)
D: Identifying new patient subtypes and endpoints for COPD (3 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre 3 Year Longitudinal Prospective Study to Identify Novel Endpoints and Compare These With Forced Expiratory Volume in 1 Second (FEV1) for Their Ability to Measure and Predict COPD Severity and Its Progression Over Time
Brief Summary: This is a 3 year longitudinal study to identify novel endpoints and compare these with standard measures such as forced expiratory volume in 1 second (FEV1) for their ability to measure and predict COPD (Chronic Obstructive Pulmonary Disease) severity and its progression over time. Control subjects (smokers and never smokers) will be recruited as comparators with the COPD subjects.


Options:
A: Proportion of Participants With Severe Asthma Exacerbations (from baseline to week 26)
B: Number of exacerbations after 48 weeks of intermittent pulse treatment (After 48 weeks of treatment)
C: To measure and compare reduction in the concentration of lower airway bacteria in patients with COPD between three different antibiotic regimes and placebo (Week 14 post treatment)
D: Identifying new patient subtypes and endpoints for COPD (3 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre 3 Year Longitudinal Prospective Study to Identify Novel Endpoints and Compare These With Forced Expiratory Volume in 1 Second (FEV1) for Their Ability to Measure and Predict COPD Severity and Its Progression Over Time
Brief Summary: This is a 3 year longitudinal study to identify novel endpoints and compare these with standard measures such as forced expiratory volume in 1 second (FEV1) for their ability to measure and predict COPD (Chronic Obstructive Pulmonary Disease) severity and its progression over time. Control subjects (smokers and never smokers) will be recruited as comparators with the COPD subjects.


Options:
A: Hospitalization-free Survival - Time to Event (From randomization until date of first hospitalization for COPD, assessed up to 26 months); Hazard Ratio for First COPD Hospitalization (26 months)
B: Identifying new patient subtypes and endpoints for COPD (3 years)
C: CCQ-recovery time in the event of an exacerbation(Health status recovery time) (6-months)
D: Number of hospital admissions for exacerbations of COPD

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre 3 Year Longitudinal Prospective Study to Identify Novel Endpoints and Compare These With Forced Expiratory Volume in 1 Second (FEV1) for Their Ability to Measure and Predict COPD Severity and Its Progression Over Time
Brief Summary: This is a 3 year longitudinal study to identify novel endpoints and compare these with standard measures such as forced expiratory volume in 1 second (FEV1) for their ability to measure and predict COPD (Chronic Obstructive Pulmonary Disease) severity and its progression over time. Control subjects (smokers and never smokers) will be recruited as comparators with the COPD subjects.


Options:
A: Health related quality of life measured by the Chronic Respiratory Questionnaire
B: Change in the Score of the Functional Outcomes of Sleep Questionnaire at Baseline and Week 8 Treatment (8 weeks)
C: Identifying new patient subtypes and endpoints for COPD (3 years)
D: all-cause mortality (one year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre 3 Year Longitudinal Prospective Study to Identify Novel Endpoints and Compare These With Forced Expiratory Volume in 1 Second (FEV1) for Their Ability to Measure and Predict COPD Severity and Its Progression Over Time
Brief Summary: This is a 3 year longitudinal study to identify novel endpoints and compare these with standard measures such as forced expiratory volume in 1 second (FEV1) for their ability to measure and predict COPD (Chronic Obstructive Pulmonary Disease) severity and its progression over time. Control subjects (smokers and never smokers) will be recruited as comparators with the COPD subjects.


Options:
A: Forced expiratory volume in 1 second (FEV1) (Measured at baseline); Emphysema, as shown on chest CT scan (Measured at baseline); Airway wall thickness on chest CT scan (Measured at baseline); COPD status (COPD participants versus control group participants) (Measured at baseline)
B: Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years (From day 30 to 4 years); Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years (From day 30 to 4 years)
C: Identifying new patient subtypes and endpoints for COPD (3 years)
D: Bronchiectasis Exacerbation (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre 3 Year Longitudinal Prospective Study to Identify Novel Endpoints and Compare These With Forced Expiratory Volume in 1 Second (FEV1) for Their Ability to Measure and Predict COPD Severity and Its Progression Over Time
Brief Summary: This is a 3 year longitudinal study to identify novel endpoints and compare these with standard measures such as forced expiratory volume in 1 second (FEV1) for their ability to measure and predict COPD (Chronic Obstructive Pulmonary Disease) severity and its progression over time. Control subjects (smokers and never smokers) will be recruited as comparators with the COPD subjects.


Options:
A: All-cause mortality (from enrollment to 1252 deaths in R2 arm); All cause mortality or hospitalizations for any reason (from enrollment to 1252 deaths)
B: Change in CD45+ cells expression over study period (12 weeks); Change in gene expression over study period (12 weeks)
C: Identifying new patient subtypes and endpoints for COPD (3 years)
D: Rates of COPD Exacerbations (up to 37 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre 3 Year Longitudinal Prospective Study to Identify Novel Endpoints and Compare These With Forced Expiratory Volume in 1 Second (FEV1) for Their Ability to Measure and Predict COPD Severity and Its Progression Over Time
Brief Summary: This is a 3 year longitudinal study to identify novel endpoints and compare these with standard measures such as forced expiratory volume in 1 second (FEV1) for their ability to measure and predict COPD (Chronic Obstructive Pulmonary Disease) severity and its progression over time. Control subjects (smokers and never smokers) will be recruited as comparators with the COPD subjects.


Options:
A: Identifying new patient subtypes and endpoints for COPD (3 years)
B: Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years (From day 30 to 4 years); Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years (From day 30 to 4 years)
C: Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85 (Week 12 + 1 day, Day 85)
D: Baseline Pre-bronchodilator FEV1 (L) (Day 1); End-value Pre-bronchodilator FEV1 (L) (up to week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre 3 Year Longitudinal Prospective Study to Identify Novel Endpoints and Compare These With Forced Expiratory Volume in 1 Second (FEV1) for Their Ability to Measure and Predict COPD Severity and Its Progression Over Time
Brief Summary: This is a 3 year longitudinal study to identify novel endpoints and compare these with standard measures such as forced expiratory volume in 1 second (FEV1) for their ability to measure and predict COPD (Chronic Obstructive Pulmonary Disease) severity and its progression over time. Control subjects (smokers and never smokers) will be recruited as comparators with the COPD subjects.


Options:
A: Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Treatment Day 85 (Visit 8) (Baseline (BL) and Day 85)
B: Identifying new patient subtypes and endpoints for COPD (3 years)
C: Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85 (Baseline (BL) and Day 85)
D: General safety and tolerability endpoints: Adverse Events (AE), HR, BP, 12- lead ECG and lung function (FEV1) and clinical laboratory safety tests (Various)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre 3 Year Longitudinal Prospective Study to Identify Novel Endpoints and Compare These With Forced Expiratory Volume in 1 Second (FEV1) for Their Ability to Measure and Predict COPD Severity and Its Progression Over Time
Brief Summary: This is a 3 year longitudinal study to identify novel endpoints and compare these with standard measures such as forced expiratory volume in 1 second (FEV1) for their ability to measure and predict COPD (Chronic Obstructive Pulmonary Disease) severity and its progression over time. Control subjects (smokers and never smokers) will be recruited as comparators with the COPD subjects.


Options:
A: COPD Assessment Test, CAT, to assess symtoms of COPD (Assess change from baseline to 10 weeks, 6 month and 12 month follow-up)
B: To evaluate impact and costs on health care resources of a telemedicine programme (TM) for severe patients discharged with oxygen and/or home mechanical ventilation (HMV) with high risk of hospital readmission. (3 years)
C: Health related quality of life (12 month follow-up); Incremental cost-effectiveness ratio (ICER) (12 month follow-up)
D: Identifying new patient subtypes and endpoints for COPD (3 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre 3 Year Longitudinal Prospective Study to Identify Novel Endpoints and Compare These With Forced Expiratory Volume in 1 Second (FEV1) for Their Ability to Measure and Predict COPD Severity and Its Progression Over Time
Brief Summary: This is a 3 year longitudinal study to identify novel endpoints and compare these with standard measures such as forced expiratory volume in 1 second (FEV1) for their ability to measure and predict COPD (Chronic Obstructive Pulmonary Disease) severity and its progression over time. Control subjects (smokers and never smokers) will be recruited as comparators with the COPD subjects.


Options:
A: Identifying new patient subtypes and endpoints for COPD (3 years)
B: Percentage decrease of sputum eosinophils from baseline (6 months)
C: Annualized Incidence Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) (Day 1 up to 393)
D: Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL (Immediately following the first IP dose through week 56)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre 3 Year Longitudinal Prospective Study to Identify Novel Endpoints and Compare These With Forced Expiratory Volume in 1 Second (FEV1) for Their Ability to Measure and Predict COPD Severity and Its Progression Over Time
Brief Summary: This is a 3 year longitudinal study to identify novel endpoints and compare these with standard measures such as forced expiratory volume in 1 second (FEV1) for their ability to measure and predict COPD (Chronic Obstructive Pulmonary Disease) severity and its progression over time. Control subjects (smokers and never smokers) will be recruited as comparators with the COPD subjects.


Options:
A: Inflammation: localisation, numbers and profile of neutrophils, eosinophils, macrophages, and CD8+T cells in bronchial biopsy specimens after 6 months and 2.5 years treatment.
B: Identifying new patient subtypes and endpoints for COPD (3 years)
C: Rate of healthcare utilisation based exacerbations of COPD
D: CRP (4 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Vitamin D Requirements During Pregnancy
Brief Summary: The purpose of this study is to determine the effectiveness of vitamin D supplementation during pregnancy starting at the beginning of the second trimester. Mothers will be randomized to one of three vitamin D dosing groups: 400, 2,000 or 4,000 international units per day. It is hypothesized that the highest dosing regimen will result in a better vitamin D status of women regardless of their ethnicity or race.


Options:
A: Change in T-cell cytokine expression (16-20 wks, 26-28 wks, and 36 wks gestation)
B: 25-Hydroxyvitamin D Concentration (7 months)
C: Amount of calcium supplement ingested (8 weeks after ANC consultation, during which recruitment into the study occurred)
D: Change in Vitamin D status, infections and inflammation across pregnancy after Vitamin D supplementation (Entry into study, mid-gestation and delivery)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Vitamin D Requirements During Pregnancy
Brief Summary: The purpose of this study is to determine the effectiveness of vitamin D supplementation during pregnancy starting at the beginning of the second trimester. Mothers will be randomized to one of three vitamin D dosing groups: 400, 2,000 or 4,000 international units per day. It is hypothesized that the highest dosing regimen will result in a better vitamin D status of women regardless of their ethnicity or race.


Options:
A: 25-Hydroxyvitamin D Concentration (7 months)
B: Microbiologically confirmed viral acute respiratory infection (URTI and/or LRTI) (0 to 6 months)
C: Change in T-cell cytokine expression (16-20 wks, 26-28 wks, and 36 wks gestation)
D: Prevention of adverse pregnancy outcome, viz preeclampsia, small for gestational age (SGA), preterm labor (18 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Multicenter Trial of Antibiotic Prophylaxis in Elective Colorectal Surgery: Single-Dose Vs. Three Doses of Second-Generation Cephalosporin
Brief Summary: To determine the optimal prophylactic antibiotics administration method in elective colorectal surgery


Options:
A: Surgical site infection following elective colorectal surgery based on surgical site assessment.
B: Number of Participants With Surgical Wound Infections From Surgery Through Post-operative Day 60 (assessed at Postop Day 1, 2, 3, 7, 30 & 60)
C: Incidence of incisional surgical site infection (SSI)
D: Surgical site infection (30 days)

Answer: C