TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Double-blind,Randomized, Placebo-controlled,Parallel-group Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 In Subjects With Primary Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events
Brief Summary: This study is a multicenter, randomized study in subjects with high cholesterol receiving highly effective statins to assess the efficacy, safety and tolerability of Bococizumab (PF-04950615;RN316) to lower LDL-C.


Options:
A: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis (From Baseline to Week 24)
B: Number of Participants With Adverse Events (48 weeks in the SOC-controlled period and up to 2 years in the All-IP period)
C: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis (From Baseline to Week 52)
D: Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12 (Baseline, Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Double-blind, Randomized, Placebo-controlled, Parallel-group Study To Assess The Efficacy, Long-term Safety And Tolerability Of Pf-04950615 In Subjects With Primary Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events
Brief Summary: This study is a multicenter, randomized study in subjects with high cholesterol receiving highly effective statins to assess the efficacy, safety and tolerability of Bococizumab (PF-04950615;RN316) to lower LDL-C.


Options:
A: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 (Baseline, Week 12)
B: Percentage of Participants Who Experienced Adverse Events (AEs) (Up to 10 weeks after last study drug administration (maximum of 86 weeks))
C: Percent Change From Baseline at Week 12 in Fasting Low Density Lipoprotein Cholesterol (LDL-C) Level for Bococizumab 150 mg Dose Group and Matched Placebo (Baseline, Week 12); Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 0 (Day 1) (Week 0 (Day 1)); Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 2 (Week 2); Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 4 (Week 4); Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 6 (Week 6); Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 8 (Week 8); Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 10 (Week 10)
D: Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 (Baseline, Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Double-blind, Randomized, Placebo-controlled, Parallel-group Study To Assess The Efficacy, Long-term Safety And Tolerability Of Pf-04950615 In Subjects With Primary Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events
Brief Summary: This study is a multicenter, randomized study in subjects with high cholesterol receiving highly effective statins to assess the efficacy, safety and tolerability of Bococizumab (PF-04950615;RN316) to lower LDL-C.


Options:
A: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis (From Baseline to Week 52)
B: Percent Change From Baseline in LDL-C at Week 52 (Baseline and Week 52)
C: The incidence of treatment-emergent adverse events in subjects treated with REGN727 or placebo, reported from the administration of study drug on day 1 to the completion of the study on day 106 (106 days)
D: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 (Baseline, Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52 Week, Phase 3 Double-blind, Randomized, Placebo-controlled, Parallel-group Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 In Subjects With Heterozygous Familial Hypercholesterolemia
Brief Summary: This is a multicenter, randomized study in subjects with heterozygous familial hypercholesterolemia receiving highly effective statins to assess the safety, efficacy and tolerability of Bococizumab (PF-04950615; RN316) to lower LDL-C.


Options:
A: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis (From Baseline to Week 52)
B: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 (Baseline, Week 12)
C: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis (From Baseline to Week 52)
D: Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 (Baseline, Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52 Week, Phase 3 Double-blind, Randomized, Placebo-controlled, Parallel-group Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 In Subjects With Heterozygous Familial Hypercholesterolemia
Brief Summary: This is a multicenter, randomized study in subjects with heterozygous familial hypercholesterolemia receiving highly effective statins to assess the safety, efficacy and tolerability of Bococizumab (PF-04950615; RN316) to lower LDL-C.


Options:
A: Percent Change From Baseline at Week 12 in Fasting Low Density Lipoprotein Cholesterol (LDL-C) Level for Bococizumab 150 mg Dose Group and Matched Placebo (Baseline, Week 12); Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 0 (Day 1) (Week 0 (Day 1)); Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 2 (Week 2); Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 4 (Week 4); Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 6 (Week 6); Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 8 (Week 8); Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 10 (Week 10)
B: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 (Baseline, Week 12)
C: Event Rate Per 100 Participant-Years For First Occurrence of Major Cardiovascular (CV) Event (From baseline until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 3.4 years))
D: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 (Baseline, Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy Basics of Bihemispheric Motorcortex Stimulation After Stroke
Brief Summary: The aim of the study is to investigate whether the combination of bihemispheric ("dual") transcranial direct current stimulation (tDCS) and motor training on 5 consecutive days facilitates motor recovery in chronic stroke. Results will be compared to a matched group of patients undergoing anodal tDCS as well as a control group receiving sham tDCS. Functional and structural magnetic resonance imaging (MRI) before/after the intervention and during a 3 month follow-up will help investigating neural correlates of expected changes in motor function of the affected upper extremity.


Options:
A: Fugl-Meyer Upper Extremity (A week prior to treatment beginning)
B: Motor Function of the Affected Upper Extremity (Change from baseline after 5 days (immediately after intervention)); Motor Function of the Affected Upper Extremity (change from baseline after 3 months)
C: Change in Upper Extremity Fugl Meyer Assessment (6 weeks from baseline); Percentage of Sessions With Adverse Events (Post treatment (6 weeks from baseline).)
D: Change in Modified Rivermead Mobility Index Score (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy Basics of Bihemispheric Motorcortex Stimulation After Stroke
Brief Summary: The aim of the study is to investigate whether the combination of bihemispheric ("dual") transcranial direct current stimulation (tDCS) and motor training on 5 consecutive days facilitates motor recovery in chronic stroke. Results will be compared to a matched group of patients undergoing anodal tDCS as well as a control group receiving sham tDCS. Functional and structural magnetic resonance imaging (MRI) before/after the intervention and during a 3 month follow-up will help investigating neural correlates of expected changes in motor function of the affected upper extremity.


Options:
A: Motor Function of the Affected Upper Extremity (Change from baseline after 5 days (immediately after intervention)); Motor Function of the Affected Upper Extremity (change from baseline after 3 months)
B: Fugl Meyer Assessment (Upper extremity) of motor recovery following stroke (assessed at one baseline session (day 4), and then again immediately following the last day of the intervention (day 18), 2 weeks (day 32), 1 month, 3 months and 6 months later.)
C: Change in Upper Limb function (Baseline and posttest (an average of 2 weeks from baseline))
D: Change in Upper Extremity Fugl Meyer Assessment (6 weeks from baseline); Percentage of Sessions With Adverse Events (Post treatment (6 weeks from baseline).)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Shared Decision Making in the Emergency Department: The Chest Pain Choice Trial
Brief Summary: Our long-term goal is to promote evidence-based patient-centered evaluation in the acute setting to more closely tailor testing to disease risk. To compare the use of risk stratification tools with usual clinical approaches to treatment selection or administration, we propose the following:

1. Test if Chest Pain Choice safely improves validated patient-centered outcome measures in a pragmatic parallel patient randomized trial.

   Hypothesis: The intervention will significantly increase patient knowledge, engagement, and satisfaction with no increase in adverse events.
2. Test if the decision aid has an effect on healthcare utilization within 30 days after enrollment.

Hypothesis: The intervention will significantly reduce the rate of hospital admission, rate of cardiac testing, and total healthcare utilization.


Options:
A: Test if Chest Pain Choice Safely Improves Patient Knowledge. (Directly following intervention (on day 1))
B: Adherence to the decision to use or not to use statins
C: The primary outcome measure was total medical costs (capped at $200,000 per individual per year) and pharmacy costs.
D: Receipt of colorectal cancer screening (24 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Shared Decision Making in the Emergency Department: The Chest Pain Choice Trial
Brief Summary: Our long-term goal is to promote evidence-based patient-centered evaluation in the acute setting to more closely tailor testing to disease risk. To compare the use of risk stratification tools with usual clinical approaches to treatment selection or administration, we propose the following:

1. Test if Chest Pain Choice safely improves validated patient-centered outcome measures in a pragmatic parallel patient randomized trial.

   Hypothesis: The intervention will significantly increase patient knowledge, engagement, and satisfaction with no increase in adverse events.
2. Test if the decision aid has an effect on healthcare utilization within 30 days after enrollment.

Hypothesis: The intervention will significantly reduce the rate of hospital admission, rate of cardiac testing, and total healthcare utilization.


Options:
A: Men's understanding that prostate cancer screening requires a decision (baseline, post intervention, post clinical visit); Men's knowledge about prostate cancer and prostate cancer screening (baseline, post intervention, post clinical visit); Men's participation in the decision about prostate cancer screening with their clinician at their preferred level (baseline, post intervention, post clinical visit)
B: Test if Chest Pain Choice Safely Improves Patient Knowledge. (Directly following intervention (on day 1))
C: Patient knowledge (Immediately after patient visit)
D: Change in severity of depression symptoms: Centre for Epidemiologic Studies Depression Scale (CES-D) (Baseline, 3 months, 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Subpopulations and Intermediate Outcome Measures in COPD Study
Brief Summary: SPIROMICS I and SPIROMICS II are observational studies of Chronic Obstructive Pulmonary Disease (COPD).

SPIROMICS I had two main aims: (1) To find groups of patients with COPD who share certain characteristics; (2) To find new ways of measuring whether or not COPD is getting worse and so provide new ways of testing whether a new treatment is working.

SPIROMICS II has three primary aims. Aim 1 is to define the natural history of "Smokers with symptoms despite preserved spirometry" and characterize the airway mucus abnormalities underlying this condition. Aim 2 is to determine the radiographic precursor lesion(s) for emphysema, and identify the molecular phenotypes underlying airway disease and emphysema. Aim 3 is to advance understanding of the biology of COPD exacerbations through analysis of predisposing baseline phenotypes, exacerbation triggers and host inflammatory response.


Options:
A: Morbidity (Up to end of follow-up (data presented up to 15 years)); Lung Function (Up to end of follow-up (data presented up to 15 years)); Mortality (Up to end of follow-up (data presented up to 15 years))
B: 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)
C: all-cause mortality (one year)
D: Bronchiectasis Exacerbation (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Intravesical Botulinum Toxin A Injection in Treatment of Interstitial Cystitis Refractory to Conventional Treatment - A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial
Brief Summary: This study was designed in a multicenter, randomized, double-blind, placebo controlled trial to test the actual therapeutic effects of intravesical BoNTA injection. The results of this study might provide clinical evidence for a better therapeutic regimen in the treatment of IC/PBS.


Options:
A: Net change of Patient Perception of Visual Analogue Scale (VAS) (Baseline and 8 weeks)
B: The change in the average pain intensity score. (The change from baseline to the end of the double-blind phase in the mean average pain intensity score (12 weeks).)
C: Number of Participants With Interstitial Cystitis Symptom Improvement (12 weeks)
D: O'Leary-Santa Interstitial Cystitis Symptom Index and Problem Index (OSPI) Score (Baseline/12 Weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: College and University Student Intervention to Increase Consent for Organ Donation
Brief Summary: The purpose of this study is to determine the effect of brief organ donation video interventions on consent for organ donation among college and university students. Our hypothesis is that the organ donation video interventions will be superior to lay health websites for increasing organ donation consent.


Options:
A: Donor registration status at 7 days (7 days)
B: enhancing rates of family communication, donor evaluations, and transplantation (6 months)
C: Proportion of students who agreed to consent to donation on the state electronic donor registry (One day)
D: Knowledge and understanding of the opportunities for and process, risks, and benefits of living kidney donation and LDKT (Up to 1 week after the transplant education day)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparing the Efficacy of Two Frequently Used Doses of Enoxaparin for VTE Prophylaxis After Bariatric Surgery
Brief Summary: Approximately two thirds of the adult population in developed countries is categorized as over-weight or obese (BMI\>30). In spite of worldwide increasing awareness, obesity is a major health concern. In the presence of numerous diets, medical therapies, and robust research, bariatric surgery remains the most effective means of weight reduction in morbidly obese patients (BMI\>40, or BMI\>35 with co-morbidities). However, bariatric surgery harbors a relatively high risk for postoperative complications; of them, venous thromboembolic events (VTE) are not common, but potentially lethal. Taken together with the propensity of morbidly obese patients to develop VTE, perioperative thromboprophylaxis is mandatory.

To date, low molecular weight heparins (LMWH) are most commonly used for VTE prophylaxis in the aforementioned population. Due to the pharmacologic properties of LMWH and the characteristics of surgically treated obese patients, the optimal dose that is to be utilized for VTE prophylaxis in this population remains unclear. Assessment of anti-FXa levels in the patients' plasma can be used in order to monitor LMWH activity. Levels of 0.2-0.5 U/ml have been proposed by some authors for VTE prophylaxis.

Few studies have compared different dosing regimens of enoxaparin (between 30mg-60mg q/12h) for VTE prophylaxis in the population undergoing bariatric surgery; nevertheless, these were small non- randomized trials, containing numerous methodological weaknesses. Hence, the optimal regimen of enoxaparin to be used for the prevention of VTE in the discussed population remains unclear.

The aim of the present study is to evaluate plasma levels of anti-FXa activity, comparing two most commonly used enoxaparin prophylactic regimens (40mg vs 60mg q/24h) in a large and homogenous cohort of sleeve gastrectomy patients. Although universally used by bariatric surgeons, the pharmacologic efficacy of these regimens has not been evaluated in patients undergoing bariatric surgery.


Options:
A: hospital care (21 days since start of trial participation); days of hospital care (21 days since start of trial participation); days of need suplemental oxigen (21 days since the start of trial participation); serum level of d-dimmer (change betwen basal level and at 14 day follow-up); serum level of creatinine (change between basal level ans at 14 day followup)
B: Anti-factor Xa plasma levels (within 3 days after surgery)
C: Number of Participants Who Are Alive and Free of Invasive Mechanical Ventilation or ECMO Through Day 28 (Day 1 to Day 28 (28 days))
D: D-dimer level (7 days post randomization); Seven-category ordinal scale recommended by the WHO (7 days post randomization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparing the Efficacy of Two Frequently Used Doses of Enoxaparin for VTE Prophylaxis After Bariatric Surgery
Brief Summary: Approximately two thirds of the adult population in developed countries is categorized as over-weight or obese (BMI\>30). In spite of worldwide increasing awareness, obesity is a major health concern. In the presence of numerous diets, medical therapies, and robust research, bariatric surgery remains the most effective means of weight reduction in morbidly obese patients (BMI\>40, or BMI\>35 with co-morbidities). However, bariatric surgery harbors a relatively high risk for postoperative complications; of them, venous thromboembolic events (VTE) are not common, but potentially lethal. Taken together with the propensity of morbidly obese patients to develop VTE, perioperative thromboprophylaxis is mandatory.

To date, low molecular weight heparins (LMWH) are most commonly used for VTE prophylaxis in the aforementioned population. Due to the pharmacologic properties of LMWH and the characteristics of surgically treated obese patients, the optimal dose that is to be utilized for VTE prophylaxis in this population remains unclear. Assessment of anti-FXa levels in the patients' plasma can be used in order to monitor LMWH activity. Levels of 0.2-0.5 U/ml have been proposed by some authors for VTE prophylaxis.

Few studies have compared different dosing regimens of enoxaparin (between 30mg-60mg q/12h) for VTE prophylaxis in the population undergoing bariatric surgery; nevertheless, these were small non- randomized trials, containing numerous methodological weaknesses. Hence, the optimal regimen of enoxaparin to be used for the prevention of VTE in the discussed population remains unclear.

The aim of the present study is to evaluate plasma levels of anti-FXa activity, comparing two most commonly used enoxaparin prophylactic regimens (40mg vs 60mg q/24h) in a large and homogenous cohort of sleeve gastrectomy patients. Although universally used by bariatric surgeons, the pharmacologic efficacy of these regimens has not been evaluated in patients undergoing bariatric surgery.


Options:
A: Anti-factor Xa plasma levels (within 3 days after surgery)
B: Combined endpoint: all-cause mortality and/ or venous thromboem-bolism and/ or arterial thromboembolism (42 days)
C: Venous thromboembolic events (VTE) (Within 30 days from randomization); Mechanical ventilation free-survival (Within 30 days from randomization); Major Adverse Cardiovascular Events (MACE) (Within 30 days from randomization); Out-of-hospital death not attributed to major injury (Within 30 days from randomization)
D: hospitalizations (30 days); all-cause death (30 days)

Answer: A