TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Aspirin/Folate Prevention of Large Bowel Polyps
Brief Summary: This is a randomized controlled trial of aspirin and/or folate supplementation for the prevention of the recurrence of neoplastic polyps (adenomas) of the large bowel.


Options:
A: The composite of cardiovascular death, myocardial infarction (MI) and stroke
B: 1 or more adenomas (For aspirin: follow-up years 1-3; For folate: follow-up years 1-3 and years 4-8)
C: The primary end point was a composite of; nonfatal myocardial infarction,; fatal myocardial infarction,; nonfatal stroke,; fatal stroke, and; sudden death attributed to coronary heart disease.
D: serum B12 status; serum folate status

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Aspirin/Folate Prevention of Large Bowel Polyps
Brief Summary: This is a randomized controlled trial of aspirin and/or folate supplementation for the prevention of the recurrence of neoplastic polyps (adenomas) of the large bowel.


Options:
A: 1 or more adenomas (For aspirin: follow-up years 1-3; For folate: follow-up years 1-3 and years 4-8)
B: Hemoglobin (February 2007-February 2008)
C: Birth Size (At birth); Gestational Age (At birth); Child growth (From birth through 24 months); Child development (Up to 7 years post enrollment); Weight-for-age Z score (WAZ) (Up to 7 years post enrollment); Height-for-age Z score (HAZ) (Up to 7 years post enrollment); Weight -for-Height Z (WHZ) or Body Mass Index Z score (BMIZ) (Up to 7 years post enrollment); Body composition (Lean mass/fat free mass index) (Up to 7 years post enrollment)
D: Use of Emergency Contraception (7 months); Use of Folate supplements (7 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Aspirin/Folate Prevention of Large Bowel Polyps
Brief Summary: This is a randomized controlled trial of aspirin and/or folate supplementation for the prevention of the recurrence of neoplastic polyps (adenomas) of the large bowel.


Options:
A: serum B12 status; serum folate status
B: 1 or more adenomas (For aspirin: follow-up years 1-3; For folate: follow-up years 1-3 and years 4-8)
C: Proportion recovered from moderate acute malnutrition (MAM) (up to 40 weeks); Maternal change in mid-upper arm circumference (MUAC) (up to 40 weeks); infant birth weight (up to 40 weeks); infant birth length (up to 40 weeks); premature delivery (up to 36 weeks)
D: red blood cell folate concentration at three time points (baseline, 8th week, 16th week)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Aspirin/Folate Prevention of Large Bowel Polyps
Brief Summary: This is a randomized controlled trial of aspirin and/or folate supplementation for the prevention of the recurrence of neoplastic polyps (adenomas) of the large bowel.


Options:
A: Recurrent colorectal adenoma (May 1996-March 2004)
B: Hemoglobin (February 2007-February 2008)
C: Birth weight; 3-month infant mortality
D: 1 or more adenomas (For aspirin: follow-up years 1-3; For folate: follow-up years 1-3 and years 4-8)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Clinical Inertia in Diabetes Care
Brief Summary: In this randomized trial we evaluate two conceptually distinct but potentially synergistic interventions designed to reduce clinical inertia in the outpatient care of adults with type 2 diabetes. The project addresses the following specific aims;

Specific Aim 1. Implement and assess two conceptually distinct but potentially synergistic interventions to reduce clinical inertia related to control of A1c, SBP, and LDL in adults with diabetes.

* Hypothesis 1. Patients of physicians who receive the Cognitive Behavioral Intervention (CBI) (Group 1) will subsequently have less Clinical Inertia than those who receive no intervention (Group 4).
* Hypothesis 2. Patients of physicians who receive the Office Systems Redesign intervention (CBI) (Group 2) will subsequently have less Clinical Inertia than those who receive no intervention (Group 4).
* Hypothesis 3. Patients of physicians who receive the combined CBI plus OSR intervention (Group 3) will subsequently have less Clinical Inertia than those who receive CBI alone (Group 1) or OSR alone (Group 2).

Specific Aim 2. Assess the impact of interventions to reduce clinical inertia on health care charges.

• Hypothesis 4. After adjustment for baseline measures of health care charges, those who receive no intervention (Group 4), will have higher total health care charges over a 24-month follow-up, relative to the patients of physicians in intervention Group 1, Group 2, or Group 3.


Options:
A: Patient Activation Measure (PAM) (Every 3 months during the 12-month trial)
B: N/A
C: Clinical inertia (12 month post intervention)
D: The following dependant variables were measured in this study;; Diabetes medical error in the 12 months post-intervention, Glycated hemoglobin (A1c) values and A1c test rates in the 12 months post-intervention, and; LDL-cholesterol levels and test rates in the 12 months post-intervention.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Clinical Inertia in Diabetes Care
Brief Summary: In this randomized trial we evaluate two conceptually distinct but potentially synergistic interventions designed to reduce clinical inertia in the outpatient care of adults with type 2 diabetes. The project addresses the following specific aims;

Specific Aim 1. Implement and assess two conceptually distinct but potentially synergistic interventions to reduce clinical inertia related to control of A1c, SBP, and LDL in adults with diabetes.

* Hypothesis 1. Patients of physicians who receive the Cognitive Behavioral Intervention (CBI) (Group 1) will subsequently have less Clinical Inertia than those who receive no intervention (Group 4).
* Hypothesis 2. Patients of physicians who receive the Office Systems Redesign intervention (CBI) (Group 2) will subsequently have less Clinical Inertia than those who receive no intervention (Group 4).
* Hypothesis 3. Patients of physicians who receive the combined CBI plus OSR intervention (Group 3) will subsequently have less Clinical Inertia than those who receive CBI alone (Group 1) or OSR alone (Group 2).

Specific Aim 2. Assess the impact of interventions to reduce clinical inertia on health care charges.

• Hypothesis 4. After adjustment for baseline measures of health care charges, those who receive no intervention (Group 4), will have higher total health care charges over a 24-month follow-up, relative to the patients of physicians in intervention Group 1, Group 2, or Group 3.


Options:
A: Participant-reported most important attribute from survey (1 day)
B: Clinical inertia (12 month post intervention)
C: Feasibility of subject recruitment; feasibility of delivery of the CHD intervention and surveys in a busy practice setting; feasibility of measuring study outcomes (Measured at the end of the study period (approximately 2 years))
D: Completion of colorectal cancer screening

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The SU.VI.MAX Study. A Randomized, Placebo-controlled Prevention Trial of the Health Effects of Antioxidant Vitamins and Minerals.
Brief Summary: It has been suggested that a low dietary intake of antioxidant vitamins and minerals increases the incidence rate of cardiovascular disease and cancer. To date, however, the published results of randomized, placebo-controlled trials of supplements containing antioxidant nutrients have not provided clear evidence of a beneficial effect. We tested the efficacy of nutritional doses of supplementation with a combination of antioxidant vitamins and minerals in reducing the incidence of cancer and ischemic cardiovascular disease in the general population.


Options:
A: Major fatal and non fatal ischemic cardiovascular events; Cancer any kind except for basal cell skin carcinoma
B: Change in mean carotid intima-media thickness; Change in maximum carotid intima-media thickness
C: Prostate cancer (Ongoing); Total cancer (Ongoing); Major cardiovascular events (Ongoing)
D: Recurrent stroke (3 years); Myocardial infarction (3 years); Death due to other vascular causes (3 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The SU.VI.MAX Study. A Randomized, Placebo-controlled Prevention Trial of the Health Effects of Antioxidant Vitamins and Minerals.
Brief Summary: It has been suggested that a low dietary intake of antioxidant vitamins and minerals increases the incidence rate of cardiovascular disease and cancer. To date, however, the published results of randomized, placebo-controlled trials of supplements containing antioxidant nutrients have not provided clear evidence of a beneficial effect. We tested the efficacy of nutritional doses of supplementation with a combination of antioxidant vitamins and minerals in reducing the incidence of cancer and ischemic cardiovascular disease in the general population.


Options:
A: Major fatal and non fatal ischemic cardiovascular events; Cancer any kind except for basal cell skin carcinoma
B: effect on cerebrospinal fluid (CSF) biomarkers related to oxidative damage (baseline and 4 months)
C: The goal is to determine the effects of the vitamin C and vitamin E on surrogate markers of atherosclerosis following an atherogenic meal in type 2 diabetes (2 months)
D: Prostate cancer (Ongoing); Total cancer (Ongoing); Major cardiovascular events (Ongoing)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The SU.VI.MAX Study. A Randomized, Placebo-controlled Prevention Trial of the Health Effects of Antioxidant Vitamins and Minerals.
Brief Summary: It has been suggested that a low dietary intake of antioxidant vitamins and minerals increases the incidence rate of cardiovascular disease and cancer. To date, however, the published results of randomized, placebo-controlled trials of supplements containing antioxidant nutrients have not provided clear evidence of a beneficial effect. We tested the efficacy of nutritional doses of supplementation with a combination of antioxidant vitamins and minerals in reducing the incidence of cancer and ischemic cardiovascular disease in the general population.


Options:
A: Cancer (Annually)
B: Major fatal and non fatal ischemic cardiovascular events; Cancer any kind except for basal cell skin carcinoma
C: Number of Participants With Prostate Cancer (Every six months for 7 to 12 years depending on when the participant was randomized.)
D: Cellular and Humoral Immune Response (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The SU.VI.MAX Study. A Randomized, Placebo-controlled Prevention Trial of the Health Effects of Antioxidant Vitamins and Minerals.
Brief Summary: It has been suggested that a low dietary intake of antioxidant vitamins and minerals increases the incidence rate of cardiovascular disease and cancer. To date, however, the published results of randomized, placebo-controlled trials of supplements containing antioxidant nutrients have not provided clear evidence of a beneficial effect. We tested the efficacy of nutritional doses of supplementation with a combination of antioxidant vitamins and minerals in reducing the incidence of cancer and ischemic cardiovascular disease in the general population.


Options:
A: Recurrent stroke (3 years); Myocardial infarction (3 years); Death due to other vascular causes (3 years)
B: Cardiovascular disease; Cancer
C: Major fatal and non fatal ischemic cardiovascular events; Cancer any kind except for basal cell skin carcinoma
D: Non-fatal Stroke, Non-fatal Myocardial Infarction or Death Due to Vascular Causes (The primary outcome was measured over a median follow-up period of 3.4 years (interquartile range IQR 1.0-5.5 years).)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The SU.VI.MAX Study. A Randomized, Placebo-controlled Prevention Trial of the Health Effects of Antioxidant Vitamins and Minerals.
Brief Summary: It has been suggested that a low dietary intake of antioxidant vitamins and minerals increases the incidence rate of cardiovascular disease and cancer. To date, however, the published results of randomized, placebo-controlled trials of supplements containing antioxidant nutrients have not provided clear evidence of a beneficial effect. We tested the efficacy of nutritional doses of supplementation with a combination of antioxidant vitamins and minerals in reducing the incidence of cancer and ischemic cardiovascular disease in the general population.


Options:
A: Change in body weight (measured at Year 2)
B: Major fatal and non fatal ischemic cardiovascular events; Cancer any kind except for basal cell skin carcinoma
C: Change in Liver Fat (baseline and 12 months); Change in Enhanced Liver Fibrosis Score (ELF) (baseline and 12 months); Change in NAFLD Fibrosis Score (baseline and 12 months); Change in Bifidobacterium Spp. (baseline and 12 months)
D: Rate of Change on the ADAS-Cog 11. (Baseline, 6, 12, 18 months); Rate of Change on CDR-SOB (18 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The SU.VI.MAX Study. A Randomized, Placebo-controlled Prevention Trial of the Health Effects of Antioxidant Vitamins and Minerals.
Brief Summary: It has been suggested that a low dietary intake of antioxidant vitamins and minerals increases the incidence rate of cardiovascular disease and cancer. To date, however, the published results of randomized, placebo-controlled trials of supplements containing antioxidant nutrients have not provided clear evidence of a beneficial effect. We tested the efficacy of nutritional doses of supplementation with a combination of antioxidant vitamins and minerals in reducing the incidence of cancer and ischemic cardiovascular disease in the general population.


Options:
A: The goal is to determine the effects of the vitamin C and vitamin E on surrogate markers of atherosclerosis following an atherogenic meal in type 2 diabetes (2 months)
B: Cognitive Measures (6 months)
C: Number of Participants With Prostate Cancer (Every six months for 7 to 12 years depending on when the participant was randomized.)
D: Major fatal and non fatal ischemic cardiovascular events; Cancer any kind except for basal cell skin carcinoma

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The SU.VI.MAX Study. A Randomized, Placebo-controlled Prevention Trial of the Health Effects of Antioxidant Vitamins and Minerals.
Brief Summary: It has been suggested that a low dietary intake of antioxidant vitamins and minerals increases the incidence rate of cardiovascular disease and cancer. To date, however, the published results of randomized, placebo-controlled trials of supplements containing antioxidant nutrients have not provided clear evidence of a beneficial effect. We tested the efficacy of nutritional doses of supplementation with a combination of antioxidant vitamins and minerals in reducing the incidence of cancer and ischemic cardiovascular disease in the general population.


Options:
A: The goal is to determine the effects of the vitamin C and vitamin E on surrogate markers of atherosclerosis following an atherogenic meal in type 2 diabetes (2 months)
B: Frequency of adverse events (baseline, monthly for 1 year, then 15 and 18 months)
C: Number of Participants With Prostate Cancer (Every six months for 7 to 12 years depending on when the participant was randomized.)
D: Major fatal and non fatal ischemic cardiovascular events; Cancer any kind except for basal cell skin carcinoma

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The SU.VI.MAX Study. A Randomized, Placebo-controlled Prevention Trial of the Health Effects of Antioxidant Vitamins and Minerals.
Brief Summary: It has been suggested that a low dietary intake of antioxidant vitamins and minerals increases the incidence rate of cardiovascular disease and cancer. To date, however, the published results of randomized, placebo-controlled trials of supplements containing antioxidant nutrients have not provided clear evidence of a beneficial effect. We tested the efficacy of nutritional doses of supplementation with a combination of antioxidant vitamins and minerals in reducing the incidence of cancer and ischemic cardiovascular disease in the general population.


Options:
A: Major fatal and non fatal ischemic cardiovascular events; Cancer any kind except for basal cell skin carcinoma
B: cardiovascular deaths and hospitalization for cardiovascular causes (5 years)
C: Number of Participants With All-cause Mortality, Cardiovascular Mortality, Stroke, and Myocardial Infarctions (1 year)
D: Changes from baseline in global cognitive composite score (2 years); Changes from baseline in macular degeneration (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The SU.VI.MAX Study. A Randomized, Placebo-controlled Prevention Trial of the Health Effects of Antioxidant Vitamins and Minerals.
Brief Summary: It has been suggested that a low dietary intake of antioxidant vitamins and minerals increases the incidence rate of cardiovascular disease and cancer. To date, however, the published results of randomized, placebo-controlled trials of supplements containing antioxidant nutrients have not provided clear evidence of a beneficial effect. We tested the efficacy of nutritional doses of supplementation with a combination of antioxidant vitamins and minerals in reducing the incidence of cancer and ischemic cardiovascular disease in the general population.


Options:
A: Number of Participants With Prostate Cancer (Every six months for 7 to 12 years depending on when the participant was randomized.)
B: Plasma selenoprotein P levels at 0, 4, 8, 12, 16, 20, 24, 32, and 40 weeks (40 weeks)
C: Major fatal and non fatal ischemic cardiovascular events; Cancer any kind except for basal cell skin carcinoma
D: Cellular and Humoral Immune Response (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: To evaluate current and novel therapies and management strategies for children with asthma. The emphasis is on clinical trials that help identify optimal therapy for children with different asthma phenotypes, genotypes, and ethnic backgrounds and children at different developmental stages.


Options:
A: Mean maximum symptom days per 2 weeks, as assessed by questionnaire (At Visits 3 and 8)
B: N/A
C: Pulmonary Function as Measured by Normalized FEV1 Over a 4-6 Year Period (At the end of treatment, 4-6 years from baseline assessment)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: To evaluate current and novel therapies and management strategies for children with asthma. The emphasis is on clinical trials that help identify optimal therapy for children with different asthma phenotypes, genotypes, and ethnic backgrounds and children at different developmental stages.


Options:
A: N/A
B: Participants Experiencing an Asthma Exacerbation That Requires Systemic Corticosteroid Therapy (Measured during the 44-week treatment period)
C: Pulmonary Function as Measured by Normalized FEV1 Over a 4-6 Year Period (At the end of treatment, 4-6 years from baseline assessment)
D: Change From Baseline in Morning Peak Expiratory Flow (PEF) (Baseline and Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Double-Blind, Randomized, Multi-Center, and Active Controlled Trial for Efficacy and Safety of Cilostazol in Acute Ischemic Stroke
Brief Summary: The purpose of this study is to study efficacy and safety of cilostazol use in patients with acute ischemic stroke.


Options:
A: Comparison of the frequency of mRS 0, 1, 2 at 90 days (at 90 days)
B: Telephone Modified Rankin Scale (Centralised, Blinded Assessment) (90 days)
C: Percentage of patients with the 3-month new vascular events, defined as any event of the following: Any stroke (ischemic or hemorrhage) (3 months)
D: Number of Participants With Composite of Stroke/MI/Death (From randomization up to 97 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Double-Blind, Randomized, Multi-Center, and Active Controlled Trial for Efficacy and Safety of Cilostazol in Acute Ischemic Stroke
Brief Summary: The purpose of this study is to study efficacy and safety of cilostazol use in patients with acute ischemic stroke.


Options:
A: Any stroke at 90 days; Stroke severity
B: Number of Patients With First Recurrent Cerebral Infarction (Fatal or Non-fatal) (Up to 124 weeks)
C: Comparison of the frequency of mRS 0, 1, 2 at 90 days (at 90 days)
D: Telephone Modified Rankin Scale (Centralised, Blinded Assessment) (90 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: International Study of Improving Treatment for the Most Severely Ill With Schizophrenia
Brief Summary: This is a 9 week, multicentre, randomized, double-blind, placebo-controlled trial with two parallel groups. There is also an open-label extension phase of 18 weeks. Both medications to be used in the study, clozapine and risperidone, are fully approved for the treatment of schizophrenia.


Options:
A: Withdrawal from allocated treatment within 3 months.
B: Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria by the End of Week 26 (Baseline to Week 26)
C: PK parameters: tmax, Cmax, AUClast, AUCinf, ke, t1/2 and clearance will be estimated for each subject and for the population using noncompartmental methods. (48 hours)
D: For 100 subjects with incomplete response to adequate treatment with clozapine, the primary objective is to determine if risperidone augmentation of clozapine is superior to augmentation with placebo, using the outcome measure of total PANSS score

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: International Study of Improving Treatment for the Most Severely Ill With Schizophrenia
Brief Summary: This is a 9 week, multicentre, randomized, double-blind, placebo-controlled trial with two parallel groups. There is also an open-label extension phase of 18 weeks. Both medications to be used in the study, clozapine and risperidone, are fully approved for the treatment of schizophrenia.


Options:
A: For 100 subjects with incomplete response to adequate treatment with clozapine, the primary objective is to determine if risperidone augmentation of clozapine is superior to augmentation with placebo, using the outcome measure of total PANSS score
B: Withdrawal from allocated treatment within 3 months.
C: Brief Psychotic Rating Scale (BPRS): Measure of efficacy will be changes in BPRS total and subscale scores from baseline to 8th week endpoint. Follow-up evaluation will be made every 6th month till 1 year after 8th week end point. (one year); Schedule for Assessment of Negative Symptoms (SANS): Measure of efficacy will be changes in SANS total and subscale scores from baseline to 8th week endpoint. Follow-up evaluation will be made at 6 month and 12 month after 8th week end point. (one year); Serum Prolactin Level (one year); Body Mass Index & Abdominal Circumference (one year); Lipid Panel with LDL Cholesterol (one year); FBS-PP & HbA1c (one year)
D: the time the patients remain stable (1 year)

Answer: A