TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Diabetes Through Primary Care Translation (IMPACT)
Brief Summary: The goal of our research program is to successfully translate empirical knowledge regarding diabetes treatment and management into sustainable clinical practice. The study hypothesis is that implementation of a multicomponent intervention will result in meaningful improvement in clinical performance measures at the clinic that include average A1c (Hemoglobin A1c), average systolic blood pressure, and national clinical performance measures at a reasonable cost to the health system.


Options:
A: doctor-confirmed dilated eye examination (3 and 6 months)
B: N/A
C: HbA1c, Triglycerides, Cholesterol, Urine Microalbumin, Blood Pressure,
D: Death or non-fatal myocardial infarction (Up to 10 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients With Active, Relapsing Forms of Multiple Sclerosis
Brief Summary: This research study is being conducted in the U.S. and Europe to evaluate the safety and efficacy of daclizumab for the treatment of multiple sclerosis (MS).


Options:
A: Annualized Relapse Rate (ARR) (Baseline up to 2.5 years)
B: Number of new or enlarged gadolinium contrast enhancing lesions (Gd-CELs) on monthly brain MRIs collected between Weeks 8 to 24 in daclizumab- vs. placebo-treated patients
C: Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks (Week 96)
D: Number of Patients Free of Gadolinium-enhanced T1-Weighted Magnetic Resonance Imaging (MRI) Lesions at Both Month 3 and Month 6 (Month 3 and Month 6)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients With Active, Relapsing Forms of Multiple Sclerosis
Brief Summary: This research study is being conducted in the U.S. and Europe to evaluate the safety and efficacy of daclizumab for the treatment of multiple sclerosis (MS).


Options:
A: Proportion of Subjects Relapsed (2 years)
B: Aggregate Annualized Relapse Rate (ARR) Estimate up to Month 24 (24 months)
C: Number of new or enlarged gadolinium contrast enhancing lesions (Gd-CELs) on monthly brain MRIs collected between Weeks 8 to 24 in daclizumab- vs. placebo-treated patients
D: Probability of Participants With Sustained Accumulation of Disability (SAD) (Up to 3 years); Annualized Relapse Rate (Up to 3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients With Active, Relapsing Forms of Multiple Sclerosis
Brief Summary: This research study is being conducted in the U.S. and Europe to evaluate the safety and efficacy of daclizumab for the treatment of multiple sclerosis (MS).


Options:
A: Primary objectives of this study are to determine if natalizumab is effective in reducing the rate of clinical relapse at 1 year and in slowing the progression of disability at 2 years as measured by EDSS. (1 year and 2 years)
B: Number of new or enlarged gadolinium contrast enhancing lesions (Gd-CELs) on monthly brain MRIs collected between Weeks 8 to 24 in daclizumab- vs. placebo-treated patients
C: Change in each participant's disease status, as measured by the Multiple Sclerosis Functional Composite score (MSFC) (Throughout study); Glatiramer acetate-specific cytokine secretion of IL-13 cytokine secretion and IFN-gamma secretion by glatiramer acetate-reactive T-cell lines (At Months 3, 6, and 12)
D: Core Treatment Period: Time to Conversion to Clinically Deﬁnite Multiple Sclerosis (CDMS) (Up to a maximum of 108 weeks depending on time of enrollment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Greenwich Lumbar Stenosis SLIP Study: A Multi-center, Randomized, Prospective Clinical Trial Comparing Spinal Laminectomy to Laminectomy With Instrumented Pedicle Screw Fusion for Lumbar Stenosis With Grade I Spondylolisthesis
Brief Summary: The purpose of the study is to determine the proper use of lower back screws and rods (instrumentation) and bony fusion in subjects with one level of degenerative spinal narrowing (stenosis) compressing nerves to the legs with one spinal bone slipping forward on another (spondylolisthesis). There are two types of operations that surgeons perform for this problem. Some spinal surgeons remove some bone in the back (laminectomy) to decompress the nerves. Other surgeons perform a laminectomy (decompression) as above, but feel that it is also important to strengthen the back by placing screws and rods into the spine and adding more bone to obtain a new bridge of bone away from the nerves (decompression with instrumented fusion). This study aims to test the hypothesis that adding instrumented fusion to a decompression for this spinal problem will improve long term patient outcomes.


Options:
A: SF-36 (physical component summary score) (2 year)
B: Changes in health-related quality of life as measured by the SF-36 health status questionnaire (Baseline, 6 wks, 3 and 6 mos, Annually thereafter)
C: Changes in health-related quality of life as measured by the SF-36 health status questionnaire (Baseline, 6 wks, 3 and 6 mos, Annually thereafter)
D: Oswestry Disability Index (ODI) (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Fast Assessment of Stroke and Transient Ischemic Attack to Prevent Early Recurrence (FASTER)
Brief Summary: Current management of patients with TIA (transient ischemic attack) or minor stroke includes the prompt investigation and treatment in the days and weeks after the event. However, new evidence shows patients are at the highest risk of stroke in the first few days after the TIA, with 50% of strokes which happen in the three months following TIA occurring within 48-72 hours. To date, there is no evidence to guide physicians on how to safely reduce this risk.

The FASTER trial is focusing on the initial period of high risk, starting patients on stroke prevention treatments in the hours following a TIA or minor stroke. The drugs to be tested have been shown to be effective in the similar setting of cardiology, reducing recurrent cardiac events in patients with unstable angina when commenced with the same speed after an event.

All patients will be on aspirin. The trial will see if adding another drug, clopidogrel, has an additional benefit in reducing the number of strokes after TIA or minor stroke within three months of TIA or minor stroke. It will also look if the very early introduction of simvastatin, a cholesterol lowering therapy, reduces stroke after TIA or minor stroke, both by itself and in addition to clopidogrel. The final aim of the trial is to ensure that these treatments are safe to be used in this population of patients.


Options:
A: Percentage of patients with the 3-month new vascular events, defined as any event of the following: Any stroke (ischemic or hemorrhage) (3 months)
B: Any stroke at 90 days; Stroke severity
C: Comparison of the frequency of mRS 0, 1, 2 at 90 days (at 90 days)
D: Composite of Ischemic Stroke, Myocardial Infarction, or Death From Ischemic Vascular Causes (Up to 90 days); Major Hemorrhage (Up to 90 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Fast Assessment of Stroke and Transient Ischemic Attack to Prevent Early Recurrence (FASTER)
Brief Summary: Current management of patients with TIA (transient ischemic attack) or minor stroke includes the prompt investigation and treatment in the days and weeks after the event. However, new evidence shows patients are at the highest risk of stroke in the first few days after the TIA, with 50% of strokes which happen in the three months following TIA occurring within 48-72 hours. To date, there is no evidence to guide physicians on how to safely reduce this risk.

The FASTER trial is focusing on the initial period of high risk, starting patients on stroke prevention treatments in the hours following a TIA or minor stroke. The drugs to be tested have been shown to be effective in the similar setting of cardiology, reducing recurrent cardiac events in patients with unstable angina when commenced with the same speed after an event.

All patients will be on aspirin. The trial will see if adding another drug, clopidogrel, has an additional benefit in reducing the number of strokes after TIA or minor stroke within three months of TIA or minor stroke. It will also look if the very early introduction of simvastatin, a cholesterol lowering therapy, reduces stroke after TIA or minor stroke, both by itself and in addition to clopidogrel. The final aim of the trial is to ensure that these treatments are safe to be used in this population of patients.


Options:
A: Any stroke at 90 days; Stroke severity
B: Platelet activation during and after the intervention (6-12 hours)
C: Number of participants with new ischemic lesions after the onset of acute atherothrombotic stroke (Within 30 days following the onset of acute atherothrombotic stroke)
D: Primary Outcome The composite of cardio-vascular death, MI, stent thrombosis, TVR and bleeding (minor or major) following randomly assigned DES implantation (12 months after stent implantation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Fast Assessment of Stroke and Transient Ischemic Attack to Prevent Early Recurrence (FASTER)
Brief Summary: Current management of patients with TIA (transient ischemic attack) or minor stroke includes the prompt investigation and treatment in the days and weeks after the event. However, new evidence shows patients are at the highest risk of stroke in the first few days after the TIA, with 50% of strokes which happen in the three months following TIA occurring within 48-72 hours. To date, there is no evidence to guide physicians on how to safely reduce this risk.

The FASTER trial is focusing on the initial period of high risk, starting patients on stroke prevention treatments in the hours following a TIA or minor stroke. The drugs to be tested have been shown to be effective in the similar setting of cardiology, reducing recurrent cardiac events in patients with unstable angina when commenced with the same speed after an event.

All patients will be on aspirin. The trial will see if adding another drug, clopidogrel, has an additional benefit in reducing the number of strokes after TIA or minor stroke within three months of TIA or minor stroke. It will also look if the very early introduction of simvastatin, a cholesterol lowering therapy, reduces stroke after TIA or minor stroke, both by itself and in addition to clopidogrel. The final aim of the trial is to ensure that these treatments are safe to be used in this population of patients.


Options:
A: Any stroke at 90 days; Stroke severity
B: Adjudicated Recurrent Stroke (From randomisation until full follow up period, approximately 43 months.); First Major Bleed (Adjudicated) (Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.)
C: Telephone Modified Rankin Scale (Centralised, Blinded Assessment) (90 days)
D: Composite of Subsequent Stroke or Death (From randomisation (day 1) to visit 3 (day 30-34))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Fast Assessment of Stroke and Transient Ischemic Attack to Prevent Early Recurrence (FASTER)
Brief Summary: Current management of patients with TIA (transient ischemic attack) or minor stroke includes the prompt investigation and treatment in the days and weeks after the event. However, new evidence shows patients are at the highest risk of stroke in the first few days after the TIA, with 50% of strokes which happen in the three months following TIA occurring within 48-72 hours. To date, there is no evidence to guide physicians on how to safely reduce this risk.

The FASTER trial is focusing on the initial period of high risk, starting patients on stroke prevention treatments in the hours following a TIA or minor stroke. The drugs to be tested have been shown to be effective in the similar setting of cardiology, reducing recurrent cardiac events in patients with unstable angina when commenced with the same speed after an event.

All patients will be on aspirin. The trial will see if adding another drug, clopidogrel, has an additional benefit in reducing the number of strokes after TIA or minor stroke within three months of TIA or minor stroke. It will also look if the very early introduction of simvastatin, a cholesterol lowering therapy, reduces stroke after TIA or minor stroke, both by itself and in addition to clopidogrel. The final aim of the trial is to ensure that these treatments are safe to be used in this population of patients.


Options:
A: The combined event of death from all vascular causes, nonfatal stroke, nonfatal myocardial infarction or major bleeding complication, whichever happens first during follow-up
B: Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke (Randomization up to 15 months)
C: Any stroke at 90 days; Stroke severity
D: acomposite of mortality, nonfatal myocardial infarction and nonfatal stroke (30 months intake; 12-42 months follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Monotherapy Versus Methotrexate Monotherapy in Patients With Moderate to Severe Active Rheumatoid Arthritis
Brief Summary: This 2 arm study will assess the safety and efficacy of tocilizumab monotherapy versus methotrexate in patients with active rheumatoid arthritis (RA). Patients will be randomized to receive tocilizumab 8mg/kg iv every 4 weeks plus placebo po weekly, or methotrexate 7.5-20mg po weekly plus placebo iv every 4 weeks. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.


Options:
A: Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years (From first dose of CZP to the end of the open-label study (approximately 7 years)); Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years (From first dose of CZP to the end of the open-label study (approximately 7 years)); Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study (From Entry Visit (Week 0) to the end of the study (approximately 6.5 years))
B: Percentage of patients with ACR 20 response (Week 24)
C: Number of patients who achieve a DAS28 < 3.2 (0, 1, 3, 6, 9, 12 and 24 months (DAS28))
D: DAS28-ESR remission at 24 weeks (at 24 week); Changes over time in the number of patients maintaining discontinuation (maintenance rate) (Week 52 to Week 104)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Monotherapy Versus Methotrexate Monotherapy in Patients With Moderate to Severe Active Rheumatoid Arthritis
Brief Summary: This 2 arm study will assess the safety and efficacy of tocilizumab monotherapy versus methotrexate in patients with active rheumatoid arthritis (RA). Patients will be randomized to receive tocilizumab 8mg/kg iv every 4 weeks plus placebo po weekly, or methotrexate 7.5-20mg po weekly plus placebo iv every 4 weeks. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.


Options:
A: Change From Baseline to Week 24 in the Disease Activity Score 28 (DAS28) (Baseline to Week 24)
B: Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 52 (Baseline and 52 Weeks); Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52 (Baseline and Week 52)
C: Percentage of patients with ACR 20 response (Week 24)
D: Mean 48-week Change in DAS28 (48 weeks after baseline assessment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Monotherapy Versus Methotrexate Monotherapy in Patients With Moderate to Severe Active Rheumatoid Arthritis
Brief Summary: This 2 arm study will assess the safety and efficacy of tocilizumab monotherapy versus methotrexate in patients with active rheumatoid arthritis (RA). Patients will be randomized to receive tocilizumab 8mg/kg iv every 4 weeks plus placebo po weekly, or methotrexate 7.5-20mg po weekly plus placebo iv every 4 weeks. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.


Options:
A: Percentage of patients with ACR 20 response (Week 24)
B: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 (Month 6); Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3 (Baseline, Month 3); Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6 (Month 6)
C: EULAR Good Response (at 24 weeks); ACR50 Response Rate (at 24 weeks); Radiographic Progression Defined by Change in Van Der Heijde-modified Total Sharp Score (at 52 weeks)
D: MRI synovitis, bone edema and erosions score (baseline, week 18 and 52)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Zinc Supplementation Impact on Child Mortality--Nepal
Brief Summary: The purpose of this study is to determine whether daily supplementation of young children in Nepal with either zinc, iron-folic acid, or both can reduce mortality and morbidity. Young children in Nepal have numerous nutritional deficiencies and high rates of morbidity and mortality. Zinc and/or iron supplementation may be a cost-effective method for reducing these risks.


Options:
A: Incidence of diarrhea (from ages 6 weeks to 18 months); respiratory tract infections (from ages 6 weeks to 18 months)
B: all cause hospitalizations in comparison to infants receiving placebo. (November 2004 to August 2007); illnesses requiring visits to healthcare providers. (November 2004 to August 2007)
C: IQ score (Aug 2007-Jan 2008)
D: Death among children 1-36 months of age

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Zinc Supplementation Impact on Child Mortality--Nepal
Brief Summary: The purpose of this study is to determine whether daily supplementation of young children in Nepal with either zinc, iron-folic acid, or both can reduce mortality and morbidity. Young children in Nepal have numerous nutritional deficiencies and high rates of morbidity and mortality. Zinc and/or iron supplementation may be a cost-effective method for reducing these risks.


Options:
A: Death among children 1-36 months of age
B: Time (hours) to resolution of clinical signs of pneumonia (31 months)
C: Time to cessation of severe pneumonia (Within 2 weeks after enrollment); The period starting from enrolment to the beginning of a 24-hour consecutive period of absence of lower chest indrawing, of hypoxia and of any danger signs. (Recovery from pneumonia within 2 weeks)
D: Preventive effect of zinc therapy on diarrhoea during the subsequent three month 14 days of enrollment; Assess the acceptability of zinc therapy during diarrhoea in young children.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Zinc Supplementation Impact on Child Mortality--Nepal
Brief Summary: The purpose of this study is to determine whether daily supplementation of young children in Nepal with either zinc, iron-folic acid, or both can reduce mortality and morbidity. Young children in Nepal have numerous nutritional deficiencies and high rates of morbidity and mortality. Zinc and/or iron supplementation may be a cost-effective method for reducing these risks.


Options:
A: all cause hospitalizations in comparison to infants receiving placebo. (November 2004 to August 2007); illnesses requiring visits to healthcare providers. (November 2004 to August 2007)
B: Death among children 1-36 months of age
C: N/A
D: Change in length and length-for-age Z-score (12 months); Change in weight and weight-for-age (12 months); Incidence of diarrhea and laboratory-confirmed malaria (12 months); Change in plasma zinc concentration (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Zinc Supplementation Impact on Child Mortality--Nepal
Brief Summary: The purpose of this study is to determine whether daily supplementation of young children in Nepal with either zinc, iron-folic acid, or both can reduce mortality and morbidity. Young children in Nepal have numerous nutritional deficiencies and high rates of morbidity and mortality. Zinc and/or iron supplementation may be a cost-effective method for reducing these risks.


Options:
A: Death among children 1-36 months of age
B: incidence of clinical malaria (if fever recorded a blood sample will be taken to determine parasite species and count) (5 months)
C: Isotope absorption into blood stream (Day 15); Isotope absorption into blood stream (Day 43)
D: Urine samples examined for schistsoma haematobium at month 0, 3. 6 and 9; Stool samples examined for schistsoma mansoni at mont 0, 3, 6 and 9; Blood samples examined for haemoglobin level mont 0 and month 9

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Zinc Supplementation Impact on Child Mortality--Nepal
Brief Summary: The purpose of this study is to determine whether daily supplementation of young children in Nepal with either zinc, iron-folic acid, or both can reduce mortality and morbidity. Young children in Nepal have numerous nutritional deficiencies and high rates of morbidity and mortality. Zinc and/or iron supplementation may be a cost-effective method for reducing these risks.


Options:
A: Death among children 1-36 months of age
B: Plasma zinc concentration (3 weeks)
C: Changes in Maternal Serum B12 Concentration From 1st to 3rd Trimester (from 1st to 3rd trimester)
D: L:M ratio at 1.5 months (1.5 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Zinc Supplementation Impact on Child Mortality--Nepal
Brief Summary: The purpose of this study is to determine whether daily supplementation of young children in Nepal with either zinc, iron-folic acid, or both can reduce mortality and morbidity. Young children in Nepal have numerous nutritional deficiencies and high rates of morbidity and mortality. Zinc and/or iron supplementation may be a cost-effective method for reducing these risks.


Options:
A: all cause hospitalizations in comparison to infants receiving placebo. (November 2004 to August 2007); illnesses requiring visits to healthcare providers. (November 2004 to August 2007)
B: Episodes of Diarrhea and additional morbidity such as acute lower respiratory tract infection, pneumonia and days with severe illness. (2 years)
C: Death among children 1-36 months of age
D: To assess if access to zinc treatment for diarrhea in the home in addition to zinc treatment of diarrhea in the clinic leads to a greater reduction in the prevalence of diarrhea than giving zinc for treatment of diarrhea in the clinic only (One year)

Answer: C