TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Look AHEAD: Action for Health in Diabetes
Brief Summary: The Look AHEAD study is a multi-center, randomized clinical trial to examine the long-term effects of a lifestyle intervention designed to achieve and maintain weight loss. The study will investigate the effects of the intervention on heart attacks, stroke and cardiovascular-related death in individuals with type 2 diabetes who are also overweight or obese.


Options:
A: Fat mass, lean mass, bone mass (BMD, BMC), total mass (measured via DXA scan) (Measured at weeks 0, 8 and 16)
B: body weight (12 months)
C: First Occurrence of a Severe Cardiovascular Event (up to 11 years)
D: Dietary intake (6 month)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Look AHEAD: Action for Health in Diabetes
Brief Summary: The Look AHEAD study is a multi-center, randomized clinical trial to examine the long-term effects of a lifestyle intervention designed to achieve and maintain weight loss. The study will investigate the effects of the intervention on heart attacks, stroke and cardiovascular-related death in individuals with type 2 diabetes who are also overweight or obese.


Options:
A: Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI) or Nonfatal Stroke (from randomization until study cut-off date (median duration of follow-up: 6.2 years)); Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Revascularization Procedure or Hospitalization for Heart Failure (HF) (from randomization until study cut-off date (median duration of follow-up: 6.2 years))
B: Blood Pressure (24-hour Ambulatory Blood Pressure Monitoring, ABPM)) (one year)
C: First Occurrence of a Severe Cardiovascular Event (up to 11 years)
D: Change in cognitive scores; Change in insulin sensitivity

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Look AHEAD: Action for Health in Diabetes
Brief Summary: The Look AHEAD study is a multi-center, randomized clinical trial to examine the long-term effects of a lifestyle intervention designed to achieve and maintain weight loss. The study will investigate the effects of the intervention on heart attacks, stroke and cardiovascular-related death in individuals with type 2 diabetes who are also overweight or obese.


Options:
A: Change in weight from baseline (12- and 24-months)
B: First Occurrence of a Severe Cardiovascular Event (up to 11 years)
C: weight (6 months and 1 year); body mass index (6 months and 1 year); % body fat (6 months and 1 year); lipids (6 months and 1 year); blood pressure (6 months and 1 year); glucose (6 months and 1 year); insulin (6 months and 1 year); HOMA index (6 months and 1 year)
D: incidence rate of DM (Follow-up in 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Look AHEAD: Action for Health in Diabetes
Brief Summary: The Look AHEAD study is a multi-center, randomized clinical trial to examine the long-term effects of a lifestyle intervention designed to achieve and maintain weight loss. The study will investigate the effects of the intervention on heart attacks, stroke and cardiovascular-related death in individuals with type 2 diabetes who are also overweight or obese.


Options:
A: Weight (baseline, 1, 2, 3 years)
B: Body mass index (BMI) at 1 year.
C: First Occurrence of a Severe Cardiovascular Event (up to 11 years)
D: Percent Change From Baseline Weight (Baseline, 2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Look AHEAD: Action for Health in Diabetes
Brief Summary: The Look AHEAD study is a multi-center, randomized clinical trial to examine the long-term effects of a lifestyle intervention designed to achieve and maintain weight loss. The study will investigate the effects of the intervention on heart attacks, stroke and cardiovascular-related death in individuals with type 2 diabetes who are also overweight or obese.


Options:
A: Weight gain during pregnancy (From 14 weeks pregnancy to delivery)
B: treatment failure (use of drug therapy for symptom control, surgical intervention, symptom deterioration of 3 points or more measured with the I-PSS, acute urinary retention, or death)
C: First Occurrence of a Severe Cardiovascular Event (up to 11 years)
D: Change in the number of incontinence episodes over 7 days, with 95% confidence intervals, between baseline and 6 weeks (6 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Heart Failure Adherence and Retention Trial (HART)
Brief Summary: This study will test whether a self-management (SM) intervention, compared to usual care, will reduce the risk for adverse clinical outcome in patients with mild to moderate heart failure.


Options:
A: Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire (Change from Baseline AFEQT at the 13th week (after the intervention) and 6 months (follow up))
B: Patient Activation Measure questionnaire (Patient Activation Measure measured at 18 months)
C: Time until all-cause death or heart-failure hospitalization (Measured over the two years of study follow-up.)
D: Cardiac Rehabilitation Enrollment (12 weeks after patient is discharged from hospital)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Heart Failure Adherence and Retention Trial (HART)
Brief Summary: This study will test whether a self-management (SM) intervention, compared to usual care, will reduce the risk for adverse clinical outcome in patients with mild to moderate heart failure.


Options:
A: HF-specific quality of life (baseline, midpoint, endpoint, 6mo); functional capacity (baseline and endpoint); Walking Test (baseline, midpoint, endpoint)
B: Time until all-cause death or heart-failure hospitalization (Measured over the two years of study follow-up.)
C: change in 6 minute walk test (3 months)
D: functional capacity (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Heart Failure Adherence and Retention Trial (HART)
Brief Summary: This study will test whether a self-management (SM) intervention, compared to usual care, will reduce the risk for adverse clinical outcome in patients with mild to moderate heart failure.


Options:
A: Time until all-cause death or heart-failure hospitalization (Measured over the two years of study follow-up.)
B: N/A
C: N/A
D: proportion of patients who successfully complete TB treatment and achieve cure.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Combined Nortriptyline and Transdermal Nicotine for Smoking Cessation
Brief Summary: Treatment of smokers with a tricyclic antidepressant, nortriptyline, can reduce tobacco withdrawal symptoms and increases long term cessation rates when combined with transdermal nicotine and a behavioral cessation programs. The study is a placebo-controlled, randomized, parallel group trial in which smokers aged 18-70 will be subject to the combination of oral and patch treatments.


Options:
A: N/A
B: Validated smoking cessation (6 months)
C: Quit Rate (4 months)
D: 7-day Prevalence of Abstinence From Cigarette Smoking at 12 Weeks (12 weeks); 7 Day Prevalence of Abstinence From Cigarette Smoking at 24 Weeks (24 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Combined Nortriptyline and Transdermal Nicotine for Smoking Cessation
Brief Summary: Treatment of smokers with a tricyclic antidepressant, nortriptyline, can reduce tobacco withdrawal symptoms and increases long term cessation rates when combined with transdermal nicotine and a behavioral cessation programs. The study is a placebo-controlled, randomized, parallel group trial in which smokers aged 18-70 will be subject to the combination of oral and patch treatments.


Options:
A: Continuous Abstinence Rate (CAR) From Week 9 Through Week 12 (Week 9 through Week 12)
B: biologically verified smoking cessation or reduction (8 weeks and delivery)
C: Seven-day point prevalence and treatment or treatment strategy (At week 6); Main effects of varenicline and nicotine patch + lozenge on smokers who remain on these medications throughout the trial as documented in questionnaires (Up to 12 weeks); Probability of response at week 12 conditional on response at week 6 and continuation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and continuation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and augmentation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and treatment switching (At 12 weeks); Probability that treatment continuation, switching, or augmentation confers benefit conditional upon failing to quit after the initial treatment with nicotine patch + lozenge for six weeks (12 weeks); Probability that treatment continuation, switching, or augmentation confers benefit conditional upon failing to quit after initial treatment with varenicline for six weeks (12 weeks)
D: Validated smoking cessation (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Combined Nortriptyline and Transdermal Nicotine for Smoking Cessation
Brief Summary: Treatment of smokers with a tricyclic antidepressant, nortriptyline, can reduce tobacco withdrawal symptoms and increases long term cessation rates when combined with transdermal nicotine and a behavioral cessation programs. The study is a placebo-controlled, randomized, parallel group trial in which smokers aged 18-70 will be subject to the combination of oral and patch treatments.


Options:
A: Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking (Week 15 - 24)
B: Proportion of Cocaine Positive Urine Tests Per Week (Weekly Measures over 12 weeks)
C: Smoking Abstinence (12 months)
D: Validated smoking cessation (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Combined Nortriptyline and Transdermal Nicotine for Smoking Cessation
Brief Summary: Treatment of smokers with a tricyclic antidepressant, nortriptyline, can reduce tobacco withdrawal symptoms and increases long term cessation rates when combined with transdermal nicotine and a behavioral cessation programs. The study is a placebo-controlled, randomized, parallel group trial in which smokers aged 18-70 will be subject to the combination of oral and patch treatments.


Options:
A: Validated smoking cessation (6 months)
B: Smoking Status (at week 48)
C: tobacco abstinence (6 months)
D: Survival abstinence rate with maintenance treatment (48 weeks after start of treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Combined Nortriptyline and Transdermal Nicotine for Smoking Cessation
Brief Summary: Treatment of smokers with a tricyclic antidepressant, nortriptyline, can reduce tobacco withdrawal symptoms and increases long term cessation rates when combined with transdermal nicotine and a behavioral cessation programs. The study is a placebo-controlled, randomized, parallel group trial in which smokers aged 18-70 will be subject to the combination of oral and patch treatments.


Options:
A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Baseline up to 30 days after last dose of study treatment or up to Week 16); Number of Participants With Psychiatric Adverse Events (Baseline up to Week 24); Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Total Score (Baseline to Week 12); Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Total Score (Baseline to Week 24); Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score (Baseline to Week 12); Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score (Baseline to Week 24); Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score (Baseline to Week 12); Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score (Baseline to Week 24); Change From Baseline to Week 12 in Simpson Angus Rating Scale (SARS) (Baseline to Week 12); Change From Baseline to Week 24 in Simpson Angus Rating Scale (SARS) (Baseline to Week 24); Number of Participants With Suicidal Behavior and / or Ideation ("Yes" Response) on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Treatment Phase (Week 1 to Week 12 (Treatment phase)); Number of Participants With Suicidal Behavior or Suicical Ideation ("Yes" Response ) on the Columbia Suicide-Severity Rating Scale (C-SSRS) During the Post Treatment Phase (Week 13 to Week 24 (Post treatment phase)); Number of Participants With Shift From Baseline to Week 12 in Clinical Global Impressions Scale-Severity (CGI-S) Score (Baseline (Bsl) to Week 12); Number of Participants With Shift From Baseline to Week 24 in Clinical Global Impressions Scale-Severity (CGI-S) Score (Baseline to Week 24); Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 1 (Baseline, Week 1); Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 12 (Baseline, Week 12); Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 24 (Baseline, Week 24)
B: Days of abstinence following the programmed lapse (7 days)
C: Validated smoking cessation (6 months)
D: Change in Smoking Behavior (Change in cigarettes per day from Week 2 to Week 5)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Fluoxetine as a Quit Smoking Aid for Depression-Prone Smokers
Brief Summary: This project is a treatment-matching study to test whether adding antidepressant pharmacotherapy to behavioral cessation treatment improves the depression-prone smoker's ability to quit, while not undermining cessation goals for the smoker who lacks a history of depression. The study target is to randomize 120 smokers with a prior history of depression and 120 smokers who lack such a history to a double-blind treatment with either 60 mg fluoxetine or placebo, while they undergo cognitive behavioral treatment to quit smoking.


Options:
A: N/A
B: tobacco abstinence (6 months)
C: The primary efficacy outcome is smoking abstinence for any continuous 4-week period (4-week CQR) during the study treatment phase.
D: 4 week continuous quit rate (CQR) at Weeks 9-12 and Weeks 4-7

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Fluoxetine as a Quit Smoking Aid for Depression-Prone Smokers
Brief Summary: This project is a treatment-matching study to test whether adding antidepressant pharmacotherapy to behavioral cessation treatment improves the depression-prone smoker's ability to quit, while not undermining cessation goals for the smoker who lacks a history of depression. The study target is to randomize 120 smokers with a prior history of depression and 120 smokers who lack such a history to a double-blind treatment with either 60 mg fluoxetine or placebo, while they undergo cognitive behavioral treatment to quit smoking.


Options:
A: tobacco abstinence (6 months)
B: Continuous Nicotine Abstinence (8 weeks)
C: Comparison of Prolonged Abstinence (up to12 weeks post-quit)
D: Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers. (3 months); Point Prevalence Abstinence at 3 Months. (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Fluoxetine as a Quit Smoking Aid for Depression-Prone Smokers
Brief Summary: This project is a treatment-matching study to test whether adding antidepressant pharmacotherapy to behavioral cessation treatment improves the depression-prone smoker's ability to quit, while not undermining cessation goals for the smoker who lacks a history of depression. The study target is to randomize 120 smokers with a prior history of depression and 120 smokers who lack such a history to a double-blind treatment with either 60 mg fluoxetine or placebo, while they undergo cognitive behavioral treatment to quit smoking.


Options:
A: tobacco abstinence (6 months)
B: continuous abstinence (CAR) from weeks 9 to 12 of treatment (3 months)
C: Treatment Satisfaction (End of treatment (seven weeks after baseline))
D: The Fagerstrom Test for Nicotine Dependence, expired CO level, and urine cotinine will be used to determine if bupropion SR, when used as an adjunct to antipsychotic medication, is superior to placebo for helping patients with schizophrenia improve their (Expired CO weekly, Fagerstrom baseline and end of study, Urine cotinine baseline, week 2 and week 8); Neuropsychological testing will be used to determine the effects of smoking cessation on patient's attention and memory function. (Beginning and end of study)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Fluoxetine as a Quit Smoking Aid for Depression-Prone Smokers
Brief Summary: This project is a treatment-matching study to test whether adding antidepressant pharmacotherapy to behavioral cessation treatment improves the depression-prone smoker's ability to quit, while not undermining cessation goals for the smoker who lacks a history of depression. The study target is to randomize 120 smokers with a prior history of depression and 120 smokers who lack such a history to a double-blind treatment with either 60 mg fluoxetine or placebo, while they undergo cognitive behavioral treatment to quit smoking.


Options:
A: tobacco abstinence (6 months)
B: Number of Participants Completing Continuous Four-week Abstinence From Smoking Between the 8-week and 11-week Post Quit Day Visits (Period between 8-week and 11-week visits post target Quit Day)
C: Continuous Nicotine Abstinence (8 weeks)
D: Biologically-verified 7-day Point Prevalence Smoking Abstinence (End of treatment (week 6))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Fluoxetine as a Quit Smoking Aid for Depression-Prone Smokers
Brief Summary: This project is a treatment-matching study to test whether adding antidepressant pharmacotherapy to behavioral cessation treatment improves the depression-prone smoker's ability to quit, while not undermining cessation goals for the smoker who lacks a history of depression. The study target is to randomize 120 smokers with a prior history of depression and 120 smokers who lack such a history to a double-blind treatment with either 60 mg fluoxetine or placebo, while they undergo cognitive behavioral treatment to quit smoking.


Options:
A: Number of Subjects With Four Week Continuous Quit Rate (CQR) (Week 9 through Week 12)
B: Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking (Week 15 - 24)
C: tobacco abstinence (6 months)
D: Proportion of Daily Cigarettes Smoked in the 4 Hours After Receiving Methadone Dose (7 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Integrated Intervention for Substance Abusers With Depressive Disorders
Brief Summary: This study is a randomized clinical trial comparing outcomes of Integrated Cognitive Behavioral Treatment plus standard medications for veterans with both substance use disorders, depressive disorders versus the most commonly administered form of therapy for substance use disorders and depression, Twelve Step Facilitation (AA/NA model) group treatment plus medications.


Options:
A: Alcohol consumption (12 weeks); Time to lapse (12 weeks); amount of alcohol consumption (12 weeks)
B: Percent Medication Adherence at 3-month Follow-up Assessment (3-month assessment); Percent Medication Adherence at 12-month Follow-up Assessment (12-month follow-up assessment)
C: Stimulant drug use as measured by urine analysis (Treatment phase: 12 weeks (3 measurements a week), Follow Up Phase: 3 months (1 measuresment a month))
D: Hamilton Depression Scale, Timeline Follow-back (substance measure) (18 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of SSRI-Resistant Depression in Adolescents (TORDIA)
Brief Summary: The purpose of the study is to determine how best to treat adolescents with depression that is "resistant" to the first SSRI antidepressant they have tried. Participants receive one of three other antidepressant medications, either alone or in combination with cognitive behavioral therapy.


Options:
A: Hamilton Depression Scale (HAM-D) - continuous (End point week 19 and Week 24)
B: N/A
C: BeckDepression Inventory : A questionnaire with 23 items to measure symptoms of depression
D: Depressive symptoms as measured by the HRSD (24-item Hamilton Rating Scale of Depression) (20 weeks after randomization (after acute treatment phase))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of SSRI-Resistant Depression in Adolescents (TORDIA)
Brief Summary: The purpose of the study is to determine how best to treat adolescents with depression that is "resistant" to the first SSRI antidepressant they have tried. Participants receive one of three other antidepressant medications, either alone or in combination with cognitive behavioral therapy.


Options:
A: Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 4 (Baseline and Week 4)
B: N/A
C: Frequency of subsequent episodes of deliberate self harm and time elapsed to future episodes of deliberate self harm (16 weeks and 68 weeks); Severity of suicidal ideation, level of depressive symptoms (16 weeks and 68 weeks)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of SSRI-Resistant Depression in Adolescents (TORDIA)
Brief Summary: The purpose of the study is to determine how best to treat adolescents with depression that is "resistant" to the first SSRI antidepressant they have tried. Participants receive one of three other antidepressant medications, either alone or in combination with cognitive behavioral therapy.


Options:
A: Mood Severity Index (Measured at Months 6 and 12)
B: Relapse of depressive symptoms (Measured at Months 3 and 9)
C: N/A
D: recurrence of depression (52 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of SSRI-Resistant Depression in Adolescents (TORDIA)
Brief Summary: The purpose of the study is to determine how best to treat adolescents with depression that is "resistant" to the first SSRI antidepressant they have tried. Participants receive one of three other antidepressant medications, either alone or in combination with cognitive behavioral therapy.


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

Answer: A