TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Extended-Release Niacin on Saphenous Vein Graft Atherosclerosis: The Atherosclerosis Lesion Progression Intervention Using Niacin Extended Release in Saphenous Vein Grafts (ALPINE-SVG) Pilot Trial
Brief Summary: Intermediate saphenous vein graft (SVG) lesions are common, have high rates of progression to severe lesions or occlusion, and are associated with high incidence of adverse clinical outcomes.

The ALPINE-SVG trial is a randomized-controlled trial of extended-release niacin vs. placebo in patients with intermediate saphenous vein graft lesions. The main hypothesis of the study is that compared to placebo, niacin administration will result in reduction in percent atheroma volume at 12-month follow-up angiography.


Options:
A: change in percent atheroma volume at 12 months intravascular ultrasonography (12 months)
B: Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Baseline and 24 Weeks); Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Baseline and 24 weeks)
C: Regression of artheriosclerotic plaque measured using functional magnetic resonance imaging.
D: Triglycerides (Measured at 24 weeks); Non-HDL-C (Measured at 24 weeks); HDL-C (Measured at 24 weeks); Total Cholesterol (Measured at 24 weeks); Total Cholesterol : HDL-C Ratio (Measured at 24 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Support From Hospital to Home for Elders: A Randomized Controlled Study
Brief Summary: The investigators will randomize 700 non-psychiatric, non-obstetric, non-surgical patients aged 55 years and older at San Francisco General Hospital (SFGH) to usual care (ten days of prescription medication, discharge summary sent to primary care provider (PCP), and outpatient appt made for patient, and patient's nurse reviews discharge plan,) or usual care plus a peridischarge intervention (a visit with specialized in-hospital discharge nurse, development of personalized discharge plan, two phone calls from a nurse practitioner(NP)/physician assistant (PA) after discharge and availability of additional calls back from NP/PA, upon patient request, to help answer questions and assist patient's transition to outpatient care, and communication with primary care/subspecialty providers). The usual care and usual care plus intervention groups will be assessed for differences in mortality and rates of rehospitalization and emergency department use 30, 90 and 180 days following discharge from the hospital.

The discharge process from the hospital to home is frequently marked by poor quality and high risk of adverse events and readmissions. It has been hypothesized that better coordinated care, personalized patient education, and follow-up calls to identify potential sources of adverse events, such as medical complications and medication errors can reduce rehospitalization and emergency room visits following discharge from the hospital. Although these interventions have been shown to reduce combined hospital readmissions and emergency department visits in English-speaking patients, none has focused on elderly patients in a diverse urban public hospital setting that includes non-English-speakers, who might benefit more than other populations from enhanced services during and after discharge from the hospital. Further, these labor-intensive interventions are costly to implement, and it is unknown whether opportunity cost of providing additional services in a limited-resource environment such as San Francisco General Hospital (SFGH) outweighs the unknown clinical benefits.


Options:
A: Overall Screening Adherence (12 months)
B: Change in blood pressure measurement at baseline and at one year follow-up (Baseline and one year follow-up)
C: Combined Emergency Department Visits and Inpatient Readmissions (30 days after discharge from hospital); Combined Emergency Department Visits and Inpatient Readmissions (90 days after discharge from hospital); Combined Emergency Department Visits and Inpatient Readmissions (180 days after discharge from hospital)
D: Patient-centered Outcome Measure = Self-reported Hunger (12 months follow-up); Medical Outcome Measure = Body Weight (12 months follow-up); Meal Satisfaction Yesterday (12 months follow-up); Feeling Full After Last Meal Yesterday (12 months follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Support From Hospital to Home for Elders: A Randomized Controlled Study
Brief Summary: The investigators will randomize 700 non-psychiatric, non-obstetric, non-surgical patients aged 55 years and older at San Francisco General Hospital (SFGH) to usual care (ten days of prescription medication, discharge summary sent to primary care provider (PCP), and outpatient appt made for patient, and patient's nurse reviews discharge plan,) or usual care plus a peridischarge intervention (a visit with specialized in-hospital discharge nurse, development of personalized discharge plan, two phone calls from a nurse practitioner(NP)/physician assistant (PA) after discharge and availability of additional calls back from NP/PA, upon patient request, to help answer questions and assist patient's transition to outpatient care, and communication with primary care/subspecialty providers). The usual care and usual care plus intervention groups will be assessed for differences in mortality and rates of rehospitalization and emergency department use 30, 90 and 180 days following discharge from the hospital.

The discharge process from the hospital to home is frequently marked by poor quality and high risk of adverse events and readmissions. It has been hypothesized that better coordinated care, personalized patient education, and follow-up calls to identify potential sources of adverse events, such as medical complications and medication errors can reduce rehospitalization and emergency room visits following discharge from the hospital. Although these interventions have been shown to reduce combined hospital readmissions and emergency department visits in English-speaking patients, none has focused on elderly patients in a diverse urban public hospital setting that includes non-English-speakers, who might benefit more than other populations from enhanced services during and after discharge from the hospital. Further, these labor-intensive interventions are costly to implement, and it is unknown whether opportunity cost of providing additional services in a limited-resource environment such as San Francisco General Hospital (SFGH) outweighs the unknown clinical benefits.


Options:
A: Any Hospital Readmission (180-day from indexed hospital discharge)
B: NIHSS Stroke Scale, relapse rate (360 days)
C: drug related problems (DRP) (7 days after patient discharge)
D: Combined Emergency Department Visits and Inpatient Readmissions (30 days after discharge from hospital); Combined Emergency Department Visits and Inpatient Readmissions (90 days after discharge from hospital); Combined Emergency Department Visits and Inpatient Readmissions (180 days after discharge from hospital)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Double-blind, Randomized, Placebo-controlled Study of the Safety and Effectiveness of AA4500 Administered Twice Per Treatment Cycle for up to Four Treatment Cycles (2 x 4) in Men With Peyronie's Disease
Brief Summary: This study is a Phase 3, double-blind, randomized, placebo-controlled study of the safety and efficacy of AA4500 0.58 mg in subjects with Peyronie's disease. Approximately 400 (267 AA4500 and 133 placebo) men will be randomized. Subjects will be screened for study eligibility within 21 days before the initial injection of study drug in the first treatment cycle.

Before dosing, subjects will be stratified by degree of penile curvature deformity (ie, 30º to 60º or 61º to 90º) and then randomized into two treatment groups to receive in a 2:1 ratio either AA4500 0.58 mg or placebo.

In this study, qualified subjects may receive up to four treatment cycles; each cycle will be separated by a period of 42 days (± 5 days). During each treatment cycle, subjects will receive two injections of study drug with at least 24 hours but not more than 72 hours between injections. After the final injection of each treatment cycle, the investigator or qualified designee will model the penile plaque in an attempt to stretch or elongate the plaque. If the subject's penile curvature is reduced to \<15 degrees after the first, second, or third cycle of injections or if further treatment is not clinically indicated, subsequent treatment cycles will not be administered.

Following the maximum of four treatment cycles, each subject will be followed for additional safety and efficacy assessments on Days 169 (± 7 days), 232 (± 7 days), 295 (± 7 days), 365 (± 7 days) (nominal weeks 24, 33, 42 and 52). Subjects randomized to placebo may receive open-label AA4500 treatment after completing this study as part of another protocol.


Options:
A: Percentage Change From Baseline in Penile Curvature (Baseline and Week 52); Change From Baseline in the Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ) (Baseline and Week 52)
B: Percentage of subjects in each group who attain degree change in penile curvature. (7 months); Percentage of subjects achieving any decrease in PDQ sub-domain scores (Psychological and Physical Symptoms, Symptom Bother). (7 months)
C: Adverse Events at Baseline (Baseline); Adverse Events at 3 Months (3 months); Adverse Events at 6 Months (6 months); Adverse Events at 9 Months (9 months)
D: Percentage Change From Baseline in Penile Curvature (Baseline and Week 36); Change From Baseline in the Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ) (Baseline and Week 36)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Effectiveness of AA4500 Administered Twice Per Treatment Cycle for Up to Four Treatment Cycles (2 x 4) in Men With Peyronie's Disease
Brief Summary: This study is a Phase 3, double-blind, randomized, placebo-controlled study of the safety and efficacy of AA4500 0.58 mg in subjects with Peyronie's disease. Approximately 300 (200 AA4500 and 100 placebo) men will be randomized. Subjects will be screened for study eligibility within 21 days before the initial injection of study drug in the first treatment cycle.

Before dosing, subjects will be stratified by degree of penile curvature (ie, 30º to 60º or 61º to 90º) and then randomized into two treatment groups to receive in a 2:1 ratio either AA4500 0.58 mg or placebo.

In this study, qualified subjects may receive up to four treatment cycles; each cycle will be separated by a period of 42 days (± 5 days). During each treatment cycle, subjects will receive two injections of study drug with at least 24 hours but not more than 72 hours between injections. After the final injection of each treatment cycle, the investigator or qualified designee will model the penile plaque in an attempt to stretch or elongate the plaque. If the subject's penile curvature is reduced to \< 15 degrees after the first, second, or third cycle of injections or if the investigator determines further treatment is not clinically indicated (eg, adverse events; allergic reaction), subsequent treatment cycles will not be administered.

Following the maximum of four treatment cycles, each subject will be followed for additional safety and efficacy assessments on Days 169 (± 7 days), 232 (± 7 days), 295 (± 7 days), 365 (± 7 days) (nominal weeks 24, 33, 42 and 52). Subjects randomized to placebo may receive open-label AA4500 treatment after completing this study as part of another protocol.


Options:
A: Percentage Change From Baseline in Penile Curvature (Baseline and Week 36); Change From Baseline in the Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ) (Baseline and Week 36)
B: Adverse Events at Baseline (Baseline); Adverse Events at 3 Months (3 months); Adverse Events at 6 Months (6 months); Adverse Events at 9 Months (9 months)
C: Percentage Change From Baseline in Penile Curvature (Baseline and Week 52); Change From Baseline in the Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ) (Baseline and Week 52)
D: Percentage Change From Baseline in Penile Curvature (Baseline and Week 52); Change From Baseline in the Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ) (Baseline and Week 52)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Multicenter Study Comparing 6xFEC With 3xFEC-3xDoc in High-risk Node-negative Patients With Operable Breast Cancer: Comparison of Efficacy and Evaluation of Clinico-pathological and Biochemical Markers as Risk Selection Criteria
Brief Summary: In low-risk node-negative breast cancer patients adjuvant chemotherapy should be spared. The identification of this subgroup can be based either on clinical and pathological or on tumour-biological criteria. Due to their high prognostic impact, the tumour-biological invasion markers uPA/PAI-1 (urokinase-type plasminogen activator and its inhibitor PAI-1) are potential candidates to effectively assess the risk of relapse in node-negative breast cancer. This study is aimed to compare the risk assessment by the traditional clinico-pathological factors and by tumour-biological factors. The second study question refers to the comparison between an adjuvant combination treatment with FE100C\*6 and a sequential treatment with FE100C\*3 and Docetaxel\*3.


Options:
A: Number of Participants With Disease-Free Survival Events (up to 10 year follow-up)
B: Relapse Free Survival (RFS) 4 vs. 6 Cycles (from baseline up to 4 years); Duration of Disease Free Survival (RFS) (from baseline up to 6.4 years)
C: Disease-Free Survival (after 10 years follow up)
D: disease free survival (at 5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial
Brief Summary: This is a randomized placebo controlled trial to evaluate whether antenatal corticosteroids can decrease the rate of neonatal respiratory support, thus decreasing the rate of NICU admissions and improving short-term outcomes in the late preterm infant. The use of antenatal corticosteroids has been shown to be beneficial in women at risk for preterm delivery prior to 34 weeks but has not been evaluated in those likely to deliver in the late preterm period


Options:
A: Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity) (Birth to 28 days)
B: Incidence of respiratory morbidity (72 hours after birth)
C: To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform manner (Longitudinal database currently funded through 3/31/2030)
D: Neonatal Composite Outcome (72 hours of life)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial
Brief Summary: This is a randomized placebo controlled trial to evaluate whether antenatal corticosteroids can decrease the rate of neonatal respiratory support, thus decreasing the rate of NICU admissions and improving short-term outcomes in the late preterm infant. The use of antenatal corticosteroids has been shown to be beneficial in women at risk for preterm delivery prior to 34 weeks but has not been evaluated in those likely to deliver in the late preterm period


Options:
A: Neonatal Composite Outcome (72 hours of life)
B: Respiratory distress syndrome; Intraventricular hemorrhage; Neonatal mortality
C: Incidence of respiratory morbidity (72 hours after birth)
D: Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity) (Birth to 28 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial
Brief Summary: This is a randomized placebo controlled trial to evaluate whether antenatal corticosteroids can decrease the rate of neonatal respiratory support, thus decreasing the rate of NICU admissions and improving short-term outcomes in the late preterm infant. The use of antenatal corticosteroids has been shown to be beneficial in women at risk for preterm delivery prior to 34 weeks but has not been evaluated in those likely to deliver in the late preterm period


Options:
A: Neonatal Composite Outcome (72 hours of life)
B: MACS: Perinatal or neonatal mortality or serious neonatal morbidity; MACS-5: Mortality or survival with severe neuro-morbidities at 5 years of age
C: Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity) (Birth to 28 days)
D: Intact survival without RDS and/or severe (gr 3-4) ICH; Follow-up study at corrected age of two years

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial
Brief Summary: This is a randomized placebo controlled trial to evaluate whether antenatal corticosteroids can decrease the rate of neonatal respiratory support, thus decreasing the rate of NICU admissions and improving short-term outcomes in the late preterm infant. The use of antenatal corticosteroids has been shown to be beneficial in women at risk for preterm delivery prior to 34 weeks but has not been evaluated in those likely to deliver in the late preterm period


Options:
A: neonatal respiratory distress (neonatal period (28 days of life))
B: Measurements of Functional Residual Capacity in Preterm Infants. (Within first 72 hours after birth); Measurements of Respiratory Compliance (Crs) in Preterm Infants. (Within first 72 hours after birth)
C: Incidence of respiratory morbidity (72 hours after birth)
D: Neonatal Composite Outcome (72 hours of life)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial
Brief Summary: This is a randomized placebo controlled trial to evaluate whether antenatal corticosteroids can decrease the rate of neonatal respiratory support, thus decreasing the rate of NICU admissions and improving short-term outcomes in the late preterm infant. The use of antenatal corticosteroids has been shown to be beneficial in women at risk for preterm delivery prior to 34 weeks but has not been evaluated in those likely to deliver in the late preterm period


Options:
A: Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity) (Birth to 28 days)
B: Neonatal Composite Outcome (72 hours of life)
C: To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform manner (Longitudinal database currently funded through 3/31/2030)
D: Incidence of respiratory morbidity (72 hours after birth)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial
Brief Summary: This is a randomized placebo controlled trial to evaluate whether antenatal corticosteroids can decrease the rate of neonatal respiratory support, thus decreasing the rate of NICU admissions and improving short-term outcomes in the late preterm infant. The use of antenatal corticosteroids has been shown to be beneficial in women at risk for preterm delivery prior to 34 weeks but has not been evaluated in those likely to deliver in the late preterm period


Options:
A: Neonatal Composite Outcome (72 hours of life)
B: neonatal respiratory distress (neonatal period (28 days of life))
C: Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity) (Birth to 28 days)
D: Measurements of Functional Residual Capacity in Preterm Infants. (Within first 72 hours after birth); Measurements of Respiratory Compliance (Crs) in Preterm Infants. (Within first 72 hours after birth)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial
Brief Summary: This is a randomized placebo controlled trial to evaluate whether antenatal corticosteroids can decrease the rate of neonatal respiratory support, thus decreasing the rate of NICU admissions and improving short-term outcomes in the late preterm infant. The use of antenatal corticosteroids has been shown to be beneficial in women at risk for preterm delivery prior to 34 weeks but has not been evaluated in those likely to deliver in the late preterm period


Options:
A: Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity) (Birth to 28 days)
B: combined rate of mortality and neurodevelopmental disability in survivors at a corrected age of 18 months. (corrected age of 18 months)
C: Incidence of respiratory morbidity (72 hours after birth)
D: Neonatal Composite Outcome (72 hours of life)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial
Brief Summary: This is a randomized placebo controlled trial to evaluate whether antenatal corticosteroids can decrease the rate of neonatal respiratory support, thus decreasing the rate of NICU admissions and improving short-term outcomes in the late preterm infant. The use of antenatal corticosteroids has been shown to be beneficial in women at risk for preterm delivery prior to 34 weeks but has not been evaluated in those likely to deliver in the late preterm period


Options:
A: The Neonatal Pain, Agitation, and Sedation scale (8 month)
B: Ductus diameter mm/kg (at postnatal age of 5 days); Cumulative dosage of morphine (at postnatal age of 5 days)
C: Neonatal Composite Outcome (72 hours of life)
D: The primary efficacy variable for this study will be the pain scores obtained during the study period. Procedural pain will be measured once a day by the PIPP scale. Chronic pain will be evaluated through the application of the EDIN scale 3 times a day. (7 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial
Brief Summary: This is a randomized placebo controlled trial to evaluate whether antenatal corticosteroids can decrease the rate of neonatal respiratory support, thus decreasing the rate of NICU admissions and improving short-term outcomes in the late preterm infant. The use of antenatal corticosteroids has been shown to be beneficial in women at risk for preterm delivery prior to 34 weeks but has not been evaluated in those likely to deliver in the late preterm period


Options:
A: Death or Chronic Lung Disease (at 36 weeks postmenstrual age); Death (36 weeks adjusted age)
B: Survival Without Bronchopulmonary Dysplasia (BPD) (36 weeks); Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery) (55 weeks)
C: Need for mechanical ventilation (Death or discharge from the NICU)
D: Neonatal Composite Outcome (72 hours of life)

Answer: D