TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment for Adolescents With Depression Study (TADS)
Brief Summary: TADS is designed to compare the effectiveness of established treatments for teenagers suffering from major depressive disorder (MDD). The treatments are: psychotherapy ("talking therapy"); medication; and the combination of psychotherapy and medication. Altogether, 432 teenagers (both males and females) ages 12 to 17, will take part in this study at 12 sites in the United States.

The TADS design will provide answers to the following questions: What is the long-term effectiveness of medication treatment of teenagers who have major depression? What is the long-term effectiveness of a specific psychotherapy ("talking therapy) in the treatment of teenagers who have major depression? How does medication treatment compare with psychotherapy in terms of effectiveness, tolerability and teenager and family acceptance? And, What is the cost-effectiveness of medication, psychotherapy and combined treatments?

The medication being used in this study is called fluoxetine. Fluoxetine is also known as Prozac. Research has shown that medications like Prozac help depression in young persons. Fluoxetine has been approved by the FDA for use in the treatment of child and adolescent (ages 7 to 17 years) depression.

The psychotherapy or "talking therapy" being used in this study is called Cognitive Behavioral Therapy (CBT). CBT is a talking therapy that will teach both the teenager and his or her family member (e.g., parent) new skills to cope better with depression. Specific topics include education about depression and the causes of depression, setting goals, monitoring mood, increasing pleasant activities, social problem-solving, correcting negative thinking, negotiation, compromise and assertiveness. CBT sessions may also help with resolving disagreements as they affect families.


Options:
A: Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 4 (Baseline and Week 4)
B: N/A
C: N/A
D: Suicidal Ideation Questionnaire - JR (SIQ-JR) (Baseline, 6 weeks, 12 weels, 24 weeks); Beck Depression Inventory - II (BDI-II) (Baseline, 6 weeks, 12 weeks, 24 weeks); Scale for Suicidal Ideation (SSI) (baseline, 6 weeks, 12 weeks, 24 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment for Adolescents With Depression Study (TADS)
Brief Summary: TADS is designed to compare the effectiveness of established treatments for teenagers suffering from major depressive disorder (MDD). The treatments are: psychotherapy ("talking therapy"); medication; and the combination of psychotherapy and medication. Altogether, 432 teenagers (both males and females) ages 12 to 17, will take part in this study at 12 sites in the United States.

The TADS design will provide answers to the following questions: What is the long-term effectiveness of medication treatment of teenagers who have major depression? What is the long-term effectiveness of a specific psychotherapy ("talking therapy) in the treatment of teenagers who have major depression? How does medication treatment compare with psychotherapy in terms of effectiveness, tolerability and teenager and family acceptance? And, What is the cost-effectiveness of medication, psychotherapy and combined treatments?

The medication being used in this study is called fluoxetine. Fluoxetine is also known as Prozac. Research has shown that medications like Prozac help depression in young persons. Fluoxetine has been approved by the FDA for use in the treatment of child and adolescent (ages 7 to 17 years) depression.

The psychotherapy or "talking therapy" being used in this study is called Cognitive Behavioral Therapy (CBT). CBT is a talking therapy that will teach both the teenager and his or her family member (e.g., parent) new skills to cope better with depression. Specific topics include education about depression and the causes of depression, setting goals, monitoring mood, increasing pleasant activities, social problem-solving, correcting negative thinking, negotiation, compromise and assertiveness. CBT sessions may also help with resolving disagreements as they affect families.


Options:
A: N/A
B: N/A
C: N/A
D: recurrence of depression (52 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment for Adolescents With Depression Study (TADS)
Brief Summary: TADS is designed to compare the effectiveness of established treatments for teenagers suffering from major depressive disorder (MDD). The treatments are: psychotherapy ("talking therapy"); medication; and the combination of psychotherapy and medication. Altogether, 432 teenagers (both males and females) ages 12 to 17, will take part in this study at 12 sites in the United States.

The TADS design will provide answers to the following questions: What is the long-term effectiveness of medication treatment of teenagers who have major depression? What is the long-term effectiveness of a specific psychotherapy ("talking therapy) in the treatment of teenagers who have major depression? How does medication treatment compare with psychotherapy in terms of effectiveness, tolerability and teenager and family acceptance? And, What is the cost-effectiveness of medication, psychotherapy and combined treatments?

The medication being used in this study is called fluoxetine. Fluoxetine is also known as Prozac. Research has shown that medications like Prozac help depression in young persons. Fluoxetine has been approved by the FDA for use in the treatment of child and adolescent (ages 7 to 17 years) depression.

The psychotherapy or "talking therapy" being used in this study is called Cognitive Behavioral Therapy (CBT). CBT is a talking therapy that will teach both the teenager and his or her family member (e.g., parent) new skills to cope better with depression. Specific topics include education about depression and the causes of depression, setting goals, monitoring mood, increasing pleasant activities, social problem-solving, correcting negative thinking, negotiation, compromise and assertiveness. CBT sessions may also help with resolving disagreements as they affect families.


Options:
A: N/A
B: Relapse of depressive symptoms (Measured at Months 3 and 9)
C: Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score (Baseline to end of week 8)
D: recurrence of depression (52 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pharmacological Association of the Angiotensin-Converting Enzyme Insertion/Deletion Polymorphism on Blood Pressure and Cardiovascular Risk in Relation to Anti-hypertensive Treatment
Brief Summary: To examine whether the association between selected hypertensive genes and combined fatal coronary heart disease and nonfatal myocardial infarction in high-risk hypertensives is modified by the type of antihypertensive treatment, leading to differential risks of coronary heart disease.


Options:
A: Blood Pressure (baseline and six month)
B: Cognitive Assessment: Trail Making Test Part B (Baseline-12 months); Cognitive Assessment: Hopkins Verbal Learning- Immediate Recall (Baseline-12 months); Cognitive Assessment: Forward Digit Span Test (Baseline-12 months)
C: N/A
D: Composite of cardiovascular death, fatal and nonfatal stroke, fatal and nonfatal myocardial infarction (heart attack)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes
Brief Summary: The BARI 2D trial is a multicenter study that uses a 2x2 factorial design, with 2400 patients being assigned at random to initial elective revascularization with aggressive medical therapy or aggressive medical therapy alone with equal probability, and simultaneously being assigned at random to an insulin providing or insulin sensitizing strategy of glycemic control (with a target value for HbA1c of less than 7.0% for all patients).

SPECIFIC AIMS

A. Primary Aim

The primary aim of the BARI 2D trial is to test the following two hypotheses of treatment efficacy in 2400 patients with Type 2 diabetes mellitus and documented stable CAD, in the setting of uniform glycemic control and intensive management of all other risk factors including dyslipidemia, hypertension, smoking, and obesity:

1. Coronary Revascularization Hypothesis: a strategy of initial elective revascularization of choice (surgical or catheter-based) combined with aggressive medical therapy results in lower 5-year mortality compared to a strategy of aggressive medical therapy alone;
2. Method of Glycemic Control Hypothesis: with a target HbA1c level of less than 7.0%, a strategy of hyperglycemia management directed at insulin sensitization results in lower 5-year mortality compared to a strategy of insulin provision.

B. Secondary Aims

The secondary aims of the BARI 2D trial include: a) comparing the death, myocardial infarction or stroke combined endpoint event rate between the revascularization versus medical therapy groups and between the insulin sensitization versus insulin provision groups; b) comparing rates of myocardial infarction, other ischemic events, angina and quality of life associated with each revascularization and hyperglycemia management strategy; c) evaluating the relative economic costs associated with the trial treatment strategies, d) exploring the effect of glycemic control strategy on the progression and mechanism of vasculopathy including changes in PAI-1 gene expression.


Options:
A: Change in Mean Pain Severity Score From Baseline to 13 Weeks (Baseline and 13 weeks)
B: Change From Baseline in Mean Pain Score on the Numeric Rating Scale (NRS). (Baseline and 9 months)
C: Number of Participants With All-Cause Mortality (five years)
D: Primary Major Macrovascular Events (Post baseline time to the first major macrovascular event up to 82 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes
Brief Summary: The BARI 2D trial is a multicenter study that uses a 2x2 factorial design, with 2400 patients being assigned at random to initial elective revascularization with aggressive medical therapy or aggressive medical therapy alone with equal probability, and simultaneously being assigned at random to an insulin providing or insulin sensitizing strategy of glycemic control (with a target value for HbA1c of less than 7.0% for all patients).

SPECIFIC AIMS

A. Primary Aim

The primary aim of the BARI 2D trial is to test the following two hypotheses of treatment efficacy in 2400 patients with Type 2 diabetes mellitus and documented stable CAD, in the setting of uniform glycemic control and intensive management of all other risk factors including dyslipidemia, hypertension, smoking, and obesity:

1. Coronary Revascularization Hypothesis: a strategy of initial elective revascularization of choice (surgical or catheter-based) combined with aggressive medical therapy results in lower 5-year mortality compared to a strategy of aggressive medical therapy alone;
2. Method of Glycemic Control Hypothesis: with a target HbA1c level of less than 7.0%, a strategy of hyperglycemia management directed at insulin sensitization results in lower 5-year mortality compared to a strategy of insulin provision.

B. Secondary Aims

The secondary aims of the BARI 2D trial include: a) comparing the death, myocardial infarction or stroke combined endpoint event rate between the revascularization versus medical therapy groups and between the insulin sensitization versus insulin provision groups; b) comparing rates of myocardial infarction, other ischemic events, angina and quality of life associated with each revascularization and hyperglycemia management strategy; c) evaluating the relative economic costs associated with the trial treatment strategies, d) exploring the effect of glycemic control strategy on the progression and mechanism of vasculopathy including changes in PAI-1 gene expression.


Options:
A: Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (week 0, week 52); Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 104 (week 0, week 104); Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 156 (week 0, week 156)
B: Primary Major Macrovascular Events (Post baseline time to the first major macrovascular event up to 82 months)
C: Full Epithelialization of the Wound (3 months of treatment with vildagliptin); Capillary Density (3 months of treatment with vildagliptin)
D: Number of Participants With All-Cause Mortality (five years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes
Brief Summary: The BARI 2D trial is a multicenter study that uses a 2x2 factorial design, with 2400 patients being assigned at random to initial elective revascularization with aggressive medical therapy or aggressive medical therapy alone with equal probability, and simultaneously being assigned at random to an insulin providing or insulin sensitizing strategy of glycemic control (with a target value for HbA1c of less than 7.0% for all patients).

SPECIFIC AIMS

A. Primary Aim

The primary aim of the BARI 2D trial is to test the following two hypotheses of treatment efficacy in 2400 patients with Type 2 diabetes mellitus and documented stable CAD, in the setting of uniform glycemic control and intensive management of all other risk factors including dyslipidemia, hypertension, smoking, and obesity:

1. Coronary Revascularization Hypothesis: a strategy of initial elective revascularization of choice (surgical or catheter-based) combined with aggressive medical therapy results in lower 5-year mortality compared to a strategy of aggressive medical therapy alone;
2. Method of Glycemic Control Hypothesis: with a target HbA1c level of less than 7.0%, a strategy of hyperglycemia management directed at insulin sensitization results in lower 5-year mortality compared to a strategy of insulin provision.

B. Secondary Aims

The secondary aims of the BARI 2D trial include: a) comparing the death, myocardial infarction or stroke combined endpoint event rate between the revascularization versus medical therapy groups and between the insulin sensitization versus insulin provision groups; b) comparing rates of myocardial infarction, other ischemic events, angina and quality of life associated with each revascularization and hyperglycemia management strategy; c) evaluating the relative economic costs associated with the trial treatment strategies, d) exploring the effect of glycemic control strategy on the progression and mechanism of vasculopathy including changes in PAI-1 gene expression.


Options:
A: Change From Baseline in Hemoglobin A1c (A1C) at Week 24 (Baseline, Week 24)
B: Diabetic nephropathy (Four years); Combined cardiovascular endpoint (Eight years); Total mortality (13 years); Years of life years gained (21 years)
C: Number of Participants With All-Cause Mortality (five years)
D: HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment (Baseline and 24 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Trial to Determine the Efficacy of AIDSVAX B/E Vaccine in Intravenous Drug Users in Bangkok, Thailand
Brief Summary: The purpose of this study is to determine if the vaccine, AIDSVAX B/E, will protect intravenous drug users from becoming infected with HIV.


Options:
A: N/A
B: Recurrence of intimate partner violence (18 months); Health-specific quality of life (18 months); Harms of screening and/or usual care (18 months)
C: Primary Outcome Measure (3 years)
D: Post-Release Opioid Relapse (Four weeks post-release)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Trial to Determine the Efficacy of AIDSVAX B/E Vaccine in Intravenous Drug Users in Bangkok, Thailand
Brief Summary: The purpose of this study is to determine if the vaccine, AIDSVAX B/E, will protect intravenous drug users from becoming infected with HIV.


Options:
A: N/A
B: prevalence of non-users of street opioid after one year of treatment will be compared between arms. (one year)
C: Primary Outcome Measure (5 years); Primary Outcome Measure (5 years); Primary Outcome Measure (5 years)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Concomitant and Adjuvant Temozolomide and Radiotherapy for Newly Diagnosed Glioblastoma Multiforme - A Randomized Phase III Study
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if radiation therapy is more effective with or without temozolomide for glioblastoma multiforme.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without temozolomide in treating patients who have newly diagnosed glioblastoma multiforme.


Options:
A: median overall survival (1 year)
B: To determine the rate of non-progressive disease at 6 months after inclusion in each arms (after half of each arms has been completed at 6 months of treatment)
C: N/A
D: Overall Survival (OS) (From randomization to date of death or last follow-up. Analysis occurs after all 390 deaths have been reported.); Progression-free Survival (PFS) (From randomization to date of progression, death, or last follow-up for progression-free survival. Analysis occurs after all 390 deaths have been reported.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Concomitant and Adjuvant Temozolomide and Radiotherapy for Newly Diagnosed Glioblastoma Multiforme - A Randomized Phase III Study
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if radiation therapy is more effective with or without temozolomide for glioblastoma multiforme.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without temozolomide in treating patients who have newly diagnosed glioblastoma multiforme.


Options:
A: Evaluation of the treatment impact on progression-free survival (5 years)
B: N/A
C: Overall survival (12 months)
D: Overall Survival (During treatment and every three months from end of treatment through end of study or approximately up to 5 years.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Concomitant and Adjuvant Temozolomide and Radiotherapy for Newly Diagnosed Glioblastoma Multiforme - A Randomized Phase III Study
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if radiation therapy is more effective with or without temozolomide for glioblastoma multiforme.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without temozolomide in treating patients who have newly diagnosed glioblastoma multiforme.


Options:
A: N/A
B: Progression-free Survival (from the date of randomisation to the date of first progression or death due to any cause, until 6 months from the date the last patient finished trial treatment (the day after the date that the last trial drug was taken))
C: Overall Survival (7 years)
D: Survival (assessed every 6 weeks for 42 weeks, then every 4 months for one year, followed by every 6 months for years 2 through 5)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Concomitant and Adjuvant Temozolomide and Radiotherapy for Newly Diagnosed Glioblastoma Multiforme - A Randomized Phase III Study
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if radiation therapy is more effective with or without temozolomide for glioblastoma multiforme.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without temozolomide in treating patients who have newly diagnosed glioblastoma multiforme.


Options:
A: N/A
B: Reduction in the EORTC QLQ-C30 scale that constitutes the patient's primary need (Baseline, 3 weeks and 8 weeks)
C: Change in patient's quality of living over time (baseline, 6,12,18,24,36 and every 12 weeks until death or end of study); Quality of end of life care (chart review at time of death and caregiver proxy interview 2-3 months after patient death); Estimate and compare the hazard ratios and median survival before and after 1 year from enrollment (From enrollment until patient death or end of study); Change in caregiver quality of life, burden and grief over time (baseline, 6,12,18,24,36, and every 12 weeks until patient death or end of study)
D: Patient Heath Related Quality of Life (HRQL) as measured by the FACT-G, QUAL-E and FACIT-Sp. (Three months after enrollment.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Concomitant and Adjuvant Temozolomide and Radiotherapy for Newly Diagnosed Glioblastoma Multiforme - A Randomized Phase III Study
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if radiation therapy is more effective with or without temozolomide for glioblastoma multiforme.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without temozolomide in treating patients who have newly diagnosed glioblastoma multiforme.


Options:
A: N/A
B: Overall survival (12 months)
C: N/A
D: Overall Survival (7 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Selenium and Vitamin E Cancer Prevention Trial (SELECT) for Prostate Cancer
Brief Summary: RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. It is not yet known which regimen of selenium and/or vitamin E may be more effective in preventing prostate cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of selenium and vitamin E, either alone or together, in preventing prostate cancer.


Options:
A: Cardiovascular disease; Cancer
B: Possible effects of B-vitamin treatment on risk of developing cancer during the trial periods (completed by 2004 and 2005) and during post-trial follow-up. (1998-2014)
C: Number of Participants With Prostate Cancer (Every six months for 7 to 12 years depending on when the participant was randomized.)
D: Prostate cancer (Ongoing); Total cancer (Ongoing); Major cardiovascular events (Ongoing)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Selenium and Vitamin E Cancer Prevention Trial (SELECT) for Prostate Cancer
Brief Summary: RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. It is not yet known which regimen of selenium and/or vitamin E may be more effective in preventing prostate cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of selenium and vitamin E, either alone or together, in preventing prostate cancer.


Options:
A: Number of Participants With Prostate Cancer (Every six months for 7 to 12 years depending on when the participant was randomized.)
B: cognitive improvement or maintenance of cognitive performance (within 3 months of treatment)
C: Frequency of adverse events (baseline, monthly for 1 year, then 15 and 18 months)
D: Prostate cancer (Ongoing); Total cancer (Ongoing); Major cardiovascular events (Ongoing)

Answer: A