TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Secondary Prevention of Small Subcortical Strokes (SPS3) Trial
Brief Summary: The goal of this study is to learn if combination antiplatelet therapy (aspirin and clopidogrel) is more effective than aspirin alone for the prevention of recurrent stroke and cognitive decline, and if intensive blood pressure control is associated with fewer recurrent strokes and cognitive decline.

On July 21, 2011 the DSMB recommended terminating the anti platelet arm of the study due to an imbalance of overall and major non-CNS hemorrhagic SAE's and total deaths in the investigational anti platelet combination of aspirin + clopidogrel and an interim statistical analysis that demonstrated futility in the investigational anti platelet arm. It was recommended that patients be continued on standard care of aspirin mono therapy until their study close-out visit. Also, recommended the continuation and completion of the plood pressure arm following the protocol.


Options:
A: Ischemic Lesion Volume Change in the Whole Forebrain on Fluid Attenuation Inversion Recovery (FLAIR) Magnetic Resonance Imaging (MRI) (Screening to 24 weeks)
B: Time to cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure [ Time Frame: From randomization; for approximately a median of 3.5 years ] (From randomization; for approximately a median of 3.5 years)
C: Evidence of clinically defined ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI (Mean follow up of 4 years); Evidence of hemorrhagic stroke; a neurologic deficit associated with intraparenchymal or subarachnoid space lesion on CT/MRI or cerebral hemorrhage demonstrated by surgery or autopsy. (within mean follow-up of 4 years)
D: Mobility - Measured by Change in Gait Speed (Change from baseline to 36 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Secondary Prevention of Small Subcortical Strokes (SPS3) Trial
Brief Summary: The goal of this study is to learn if combination antiplatelet therapy (aspirin and clopidogrel) is more effective than aspirin alone for the prevention of recurrent stroke and cognitive decline, and if intensive blood pressure control is associated with fewer recurrent strokes and cognitive decline.

On July 21, 2011 the DSMB recommended terminating the anti platelet arm of the study due to an imbalance of overall and major non-CNS hemorrhagic SAE's and total deaths in the investigational anti platelet combination of aspirin + clopidogrel and an interim statistical analysis that demonstrated futility in the investigational anti platelet arm. It was recommended that patients be continued on standard care of aspirin mono therapy until their study close-out visit. Also, recommended the continuation and completion of the plood pressure arm following the protocol.


Options:
A: Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only) (time since randomization; follow-up period is 1.5 to 4.4 years); Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Telmisartan vs. Placebo Only) (time since randomization; follow-up period is 1.5 to 4.4 years)
B: Evidence of clinically defined ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI (Mean follow up of 4 years); Evidence of hemorrhagic stroke; a neurologic deficit associated with intraparenchymal or subarachnoid space lesion on CT/MRI or cerebral hemorrhage demonstrated by surgery or autopsy. (within mean follow-up of 4 years)
C: Volume of white matter changes (WMCs) (baseline, week 104)
D: The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death (For each participant, the first occurrence of the composite primary efficacy outcome after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.); The First Occurrence of the Primary Safety Outcome Major Bleeding Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria (For each participant, the first occurrence of modified ISTH major bleeding after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Secondary Prevention of Small Subcortical Strokes (SPS3) Trial
Brief Summary: The goal of this study is to learn if combination antiplatelet therapy (aspirin and clopidogrel) is more effective than aspirin alone for the prevention of recurrent stroke and cognitive decline, and if intensive blood pressure control is associated with fewer recurrent strokes and cognitive decline.

On July 21, 2011 the DSMB recommended terminating the anti platelet arm of the study due to an imbalance of overall and major non-CNS hemorrhagic SAE's and total deaths in the investigational anti platelet combination of aspirin + clopidogrel and an interim statistical analysis that demonstrated futility in the investigational anti platelet arm. It was recommended that patients be continued on standard care of aspirin mono therapy until their study close-out visit. Also, recommended the continuation and completion of the plood pressure arm following the protocol.


Options:
A: Evidence of clinically defined ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI (Mean follow up of 4 years); Evidence of hemorrhagic stroke; a neurologic deficit associated with intraparenchymal or subarachnoid space lesion on CT/MRI or cerebral hemorrhage demonstrated by surgery or autopsy. (within mean follow-up of 4 years)
B: Any stroke at 90 days; Stroke severity
C: The combined end point of minor, moderate or major bleeding complications during the initial hospitalization & one year follow-up. (TIMI & GUSTO criteria). (1 year)
D: The combined event of death from all vascular causes, nonfatal stroke, nonfatal myocardial infarction or major bleeding complication, whichever happens first during follow-up

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Secondary Prevention of Small Subcortical Strokes (SPS3) Trial
Brief Summary: The goal of this study is to learn if combination antiplatelet therapy (aspirin and clopidogrel) is more effective than aspirin alone for the prevention of recurrent stroke and cognitive decline, and if intensive blood pressure control is associated with fewer recurrent strokes and cognitive decline.

On July 21, 2011 the DSMB recommended terminating the anti platelet arm of the study due to an imbalance of overall and major non-CNS hemorrhagic SAE's and total deaths in the investigational anti platelet combination of aspirin + clopidogrel and an interim statistical analysis that demonstrated futility in the investigational anti platelet arm. It was recommended that patients be continued on standard care of aspirin mono therapy until their study close-out visit. Also, recommended the continuation and completion of the plood pressure arm following the protocol.


Options:
A: Evidence of clinically defined ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI (Mean follow up of 4 years); Evidence of hemorrhagic stroke; a neurologic deficit associated with intraparenchymal or subarachnoid space lesion on CT/MRI or cerebral hemorrhage demonstrated by surgery or autopsy. (within mean follow-up of 4 years)
B: First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. (4.9 years); First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. (4.7 years); First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. (4.7 years)
C: First occurrence of death or nonfatal myocardial infarction (MI) or nonfatal stroke
D: Mobility - Measured by Change in Gait Speed (Change from baseline to 36 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Trial of Male Circumcision to Reduce HIV Incidence
Brief Summary: The Luo tribe of Kisumu, Kenya, does not traditionally practice male circumcision (MC). This study will work with the Luo tribe to test the effectiveness of MC on reducing the risk of HIV infections in young men.


Options:
A: Measure the protective effect of medicalized male circumcision on HIV infection (M3, M12 and M21)
B: HIV sero-incidence (24 months post-baseline)
C: HIV incidence (2 years); surgical complications (2 years)
D: Kaplan-Meier Estimate of HIV-1 Infection Rate in Intent to Treat Population (42 Months); Vaccine Efficacy as Determined by Acquisition of Infection in the Per-protocol Population (42 Months); Changes in HIV-1 Viral Load in Volunteers Developing HIV Infection During the Trial for the MITT Population (42 months); Changes in HIV-1 Viral Load in Volunteers Developing HIV Infection During the Trial for the Per Protocol Population (42 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Trial of Male Circumcision to Reduce HIV Incidence
Brief Summary: The Luo tribe of Kisumu, Kenya, does not traditionally practice male circumcision (MC). This study will work with the Luo tribe to test the effectiveness of MC on reducing the risk of HIV infections in young men.


Options:
A: Pain scores on the Visual Analog Scale (Within the first 48 hours after circumcision); Number of Participants with Adverse Events as a Measure of Safety and Tolerability (Up to six weeks after surgery)
B: The study's primary goal is to compare the PrePex™ circumcision procedure with one of the approved WHO methods of surgical circumcision. (9 weeks)
C: HIV incidence (2 years); surgical complications (2 years)
D: HIV acquisition; safety of circumcision

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Increased Access to Emergency Contraceptive Pills
Brief Summary: This study will evaluate the effect of easy access to emergency contraceptive pills (ECPs) on the rates of pregnancy and sexually transmitted infections (STIs).


Options:
A: N/A
B: Initiation of long term contraception with 6 month postpartum (6 month)
C: Pregnancy (efficacy) (until follow-up about one week after next menses)
D: Pregnancy rates in first month after IUD insertion (4 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Increased Access to Emergency Contraceptive Pills
Brief Summary: This study will evaluate the effect of easy access to emergency contraceptive pills (ECPs) on the rates of pregnancy and sexually transmitted infections (STIs).


Options:
A: HIV incidence
B: rates of STIs (Baseline, 6 and 12 months); computer-assisted survey results (baseline, 1 week, 3, 6, & 12 months); - score on self-report of frequency of risky sexual and substance use behaviors (baseline, 1 week, 3, 6, & 12 months)
C: N/A
D: Incidence of vaginal sexual intercourse measured (Measured at Months 3 and 12 post-treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Increased Access to Emergency Contraceptive Pills
Brief Summary: This study will evaluate the effect of easy access to emergency contraceptive pills (ECPs) on the rates of pregnancy and sexually transmitted infections (STIs).


Options:
A: N/A
B: Pregnancy rates in first month after IUD insertion (4 weeks)
C: Initiation of long term contraception with 6 month postpartum (6 month)
D: Pregnancy (efficacy) (until follow-up about one week after next menses)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety and Efficacy of AMG0001 to Improve Perfusion in Critical Leg Ischemia
Brief Summary: The primary purpose of this study was to assess the overall safety of different dose regimens of AMG0001 (HGF transferred via plasmid vector) as well as evaluate the improvement of blood perfusion in subjects with critical limb ischemia (CLI). This study also evaluated the improvement in wound healing without adverse effects on the quality of life, as well as the potential reduction of amputation, mortality and rest pain in the CLI population.


Options:
A: Tissue perfusion as measured by TcPO2 (6 months)
B: Enhancement of vessel formation accessed by Nuclear Perfusion Scan in critical limb ischemia. (4 months)
C: adverse events (6 months); ankle-brachial systolic pressure index (3 mo); transcutaneous oxygen value (mm Torr) (3 mo); quality of life (questionnaires) (3 mo)
D: Primary efficacy parameter: ulcer healing.; Ulcers will be evaluated at each visit primarily by collecting quantitative and qualitative information.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety and Efficacy of AMG0001 to Improve Perfusion in Critical Leg Ischemia
Brief Summary: The primary purpose of this study was to assess the overall safety of different dose regimens of AMG0001 (HGF transferred via plasmid vector) as well as evaluate the improvement of blood perfusion in subjects with critical limb ischemia (CLI). This study also evaluated the improvement in wound healing without adverse effects on the quality of life, as well as the potential reduction of amputation, mortality and rest pain in the CLI population.


Options:
A: Time to major amputation of the treated leg or death from any cause, whichever comes first (From randomization up to 12 months)
B: Tissue perfusion as measured by TcPO2 (6 months)
C: Change in the measurement of pain-free walking distance (PWD) on treadmill (3 months and 6 months after the first injection of Neovasculgen®.)
D: Peak Walking Time (at 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Inpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder
Brief Summary: The purpose of this study is to determine the safety and effectiveness of Depakote ER compared to placebo in the treatment of bipolar disorder, manic or mixed type in adults.


Options:
A: Change from baseline to the final evaluation for the MRS from the SADS-C for the intent-to-treat dataset.
B: Sedation Score (Day 4, Day 9, Day 15, and then Weekly from Week 3 to Week 9); Young Mania Rating Scale (YMRS) Scores (Day 4, Day 9, Day 15, and then Weekly from Week 3 to Week 9)
C: The primary outcome measure will be change in hypomanic/manic symptoms from baseline to endpoint. (8 weeks)
D: To test the superiority of olanzapine compared with divalproex in improving overall manic symptomatology in patients with mild to moderate; mania associated with bipolar I disorder, as measured by reductions on the Young Mania Rating Scale (YMRS) total score from baseline to the endpoint of Study Period II (3-week acute therapy phase).

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: SAINT (Stroke - Acute Ischemic - NXY Treatment) A Double Blind, Randomized, Placebo Controlled, Parallel Group, Multicenter, Phase IIb/III Study to Assess the Efficacy and Safety of Intravenous NXY-059 in Acute Ischemic Stroke
Brief Summary: This study will determine if NXY-059 will improve recovery from an acute stroke. The study is designed to look at both overall recovery and recovery of motor function, for example muscle strengthen and coordination.


Options:
A: the improvement ratio of Fugl-Meyer assessment (after 3 weeks)
B: Modified Rankin Scale score at day 90 (or earlier in the event of patient withdrawal). (Day 90)
C: National Institutes of Health Stroke Scale Score (At 11-day and 21-day after therapy)
D: Global disability on modified Rankin scale at 90 days.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: SAINT (Stroke - Acute Ischemic - NXY Treatment) A Double Blind, Randomized, Placebo Controlled, Parallel Group, Multicenter, Phase IIb/III Study to Assess the Efficacy and Safety of Intravenous NXY-059 in Acute Ischemic Stroke
Brief Summary: This study will determine if NXY-059 will improve recovery from an acute stroke. The study is designed to look at both overall recovery and recovery of motor function, for example muscle strengthen and coordination.


Options:
A: Change From Baseline in Alzheimer's Disease Assessment Scale Cognitive Subpart (Extended Version) (ADAS-COG+) at Week 28 (baseline and week 28); Clinical Interview-based Impression of Change (CIBIC+) Score (week 28)
B: the improvement ratio of Fugl-Meyer assessment (after 3 weeks)
C: Modified Rankin Scale score at day 90 (or earlier in the event of patient withdrawal). (Day 90)
D: Global disability on modified Rankin scale at 90 days.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: SAINT (Stroke - Acute Ischemic - NXY Treatment) A Double Blind, Randomized, Placebo Controlled, Parallel Group, Multicenter, Phase IIb/III Study to Assess the Efficacy and Safety of Intravenous NXY-059 in Acute Ischemic Stroke
Brief Summary: This study will determine if NXY-059 will improve recovery from an acute stroke. The study is designed to look at both overall recovery and recovery of motor function, for example muscle strengthen and coordination.


Options:
A: National Institutes of Health Stroke Scale Score (At 11-day and 21-day after therapy)
B: the improvement ratio of Fugl-Meyer assessment (after 3 weeks)
C: Global disability on modified Rankin scale at 90 days.
D: Modified Rankin Scale score at day 90 (or earlier in the event of patient withdrawal). (Day 90)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: SAINT (Stroke - Acute Ischemic - NXY Treatment) A Double Blind, Randomized, Placebo Controlled, Parallel Group, Multicenter, Phase IIb/III Study to Assess the Efficacy and Safety of Intravenous NXY-059 in Acute Ischemic Stroke
Brief Summary: This study will determine if NXY-059 will improve recovery from an acute stroke. The study is designed to look at both overall recovery and recovery of motor function, for example muscle strengthen and coordination.


Options:
A: Modified Rankin Scale (90 days after start of treatment); Barthel Index (90 days after start of treatment); NIH Stroke Scale (90 days after start of treatment)
B: National Institutes of Health Stroke Scale Score (At 11-day and 21-day after therapy)
C: Modified Rankin Scale score at day 90 (or earlier in the event of patient withdrawal). (Day 90)
D: Global disability on modified Rankin scale at 90 days.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of Pediatric CI Therapy
Brief Summary: Pediatric Constraint-Induced (CI) Movement therapy is a rehabilitation program designed to improve motor function in children with partial paralysis. Children with cerebral palsy may have one arm that has significantly greater function (good arm) than the other (bad arm). Restricting the use of the good arm may improve the use of the bad arm. In pediatric CI therapy, the good arm is put in a sling to force increased use of the bad arm. The bad arm is also trained each day for several weeks. This study will test the ability of pediatric CI therapy to improve motor function in children with cerebral palsy.


Options:
A: Canadian Occupational Performance Measure (COPM). (Completed 2 weeks or less before treatment day 1); Canadian Occupational Performance Measure (COPM) (Completed day 5 after treatment day 10); Canadian Occupational Performance Measure (COPM) (Completed 2 months after treatment day 10); Canadian Occupational Performance Measure (COPM) (Completed 6 months after treatment day 10)
B: N/A
C: Hand function assessment (Pretest, posttest)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Maternal to Infant HIV Transmission in India
Brief Summary: Infants who are breast-fed by HIV infected mothers have an increased risk of becoming infected with HIV. Standard therapy for the prevention of HIV infections in infants included zidovudine (ZDV) prior to the onset of labor, a single dose of nevirapine (NVP) for women during labor, and a single dose of NVP for newborns given 72 hours after birth. This study will determine if giving low dose daily NVP to breastfed infants of HIV infected mothers, in addition to standard therapy, will be more effective than standard therapy alone at preventing HIV infections in these infants.


Options:
A: 1. To estimate the cumulative risk of infant infection at 6 weeks, 9 months, and 18 months of age among breast fed infants. The anticipated outcome is a transmission rate of <6% at 6 weeks and <8% at 18 months of age. (6 weeks, 9 months, 18 months)
B: HIV PCR (1 month)
C: HIV infection rate of infants (6 months of age); Safety of the regimens for HIV-infected mothers and their breast-fed infants (Through 12 months post-partum)
D: Outcome 1: Serial HIV-1 RNA Levels in Breastmilk. (Weeks 0, 1, 2, 3 and 4)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Maternal to Infant HIV Transmission in India
Brief Summary: Infants who are breast-fed by HIV infected mothers have an increased risk of becoming infected with HIV. Standard therapy for the prevention of HIV infections in infants included zidovudine (ZDV) prior to the onset of labor, a single dose of nevirapine (NVP) for women during labor, and a single dose of NVP for newborns given 72 hours after birth. This study will determine if giving low dose daily NVP to breastfed infants of HIV infected mothers, in addition to standard therapy, will be more effective than standard therapy alone at preventing HIV infections in these infants.


Options:
A: HIV PCR (1 month)
B: Infant HIV infection status (At Months 6 and 12)
C: HIV infection detected by 4 months among children with no evidence of HIV infection at birth. (24 months of age); Magnitude of the reduction in mother-to-child HIV transmission and the magnitude of the increase in non-HIV-related under-2-year mortality, attributable to cessation of breastfeeding at 4 months.
D: HIV infection rate of infants (6 months of age); Safety of the regimens for HIV-infected mothers and their breast-fed infants (Through 12 months post-partum)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Randomized, Double Masked, Active Treatment-Controlled Study of the Efficacy and Safety of rhuFab V2 (Ranibizumab) Compared With Verteporfin (Visudyne) Photodynamic Therapy in Subjects With Predominantly Classic Subfoveal Neovascular Age-Related Macular Degeneration
Brief Summary: This is a phase III, multicenter, randomized, double-masked, active treatment-controlled study of intravitreally administered ranibizumab compared with verteporfin (Visudyne) photodynamic therapy (PDT) in treating subfoveal neovascular mascular degeneration.


Options:
A: Change From Baseline in Visual-acuity Score (Continuous) (Baseline and 1 Year)
B: N/A
C: Percentage of Patients Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF) (Baseline and at week 52)
D: Percentage of Participants Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF) (At week 52)

Answer: B