TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Depression After Coronary Bypass Surgery
Brief Summary: This randomized controlled trial will test the efficacy of (1) cognitive behavior therapy and (2) supportive stress management as treatments for depression in people who have recently undergone coronary artery bypass graft surgery.


Options:
A: Admission to hospital for recurrent CHD event (8 years)
B: Hamilton Rating Scale for Depression (HAM-D-17) (12 weeks post-randomization)
C: Psychological distress (Within one year after the treatment)
D: Low-density lipoprotein (LDL)cholesterol (Baseline and 12 months); Blood pressure (baseline and 12 months); Body Mass Index (baseline and 12 months); Psychological Well-Being (Baseline and 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Depression in Macular Degeneration
Brief Summary: This study will evaluate the effectiveness of a Problem Solving Treatment in preventing depression in elderly patients with age-related macular degeneration (AMD).


Options:
A: Depression (4 months)
B: Depression as Assessed by the Quick Inventory of Depressive Symptomatology-Self Rated 16 (QIDS-SR-16) (Measured pre-treatment and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 28)
C: Depression (6 Months)
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: Preventing Depression in Macular Degeneration
Brief Summary: This study will evaluate the effectiveness of a Problem Solving Treatment in preventing depression in elderly patients with age-related macular degeneration (AMD).


Options:
A: Core Study: Difference Between the Baseline Level of Visual Acuity (Letters) of the Study Eye and the Mean Visual Acuity Averaged Over All Monthly Post-baseline Assessments From Month 1 to Month 12 (Baseline through the end of study (Month 12)); Extension Study: Percentage of Participants With Ocular Adverse Events (AEs) in the Study Eye in the 24 Month Extension Study (Extension baseline (Month 12 -end of core study) to Month 36 (end of extension study) [24 Months]); Extension Study: Percentage of Participants With Non-Ocular Adverse Events (AEs) in the 24 Month Extension Study (Extension baseline (Month 12 -end of core study) to Month 36 (end of extension study) [24 Months])
B: Depression (6 Months)
C: VA LV VFQ-48 Reading Domain Scores (4 months from baseline)
D: Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Month 24 (Baseline to Month 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Study of Liposomal Doxorubicin Plus Carboplatin Versus Carboplatin in Platinum-Sensitive Patients With Recurrent Epithelial Ovarian and Peritoneal Carcinoma After Failure of Initial Platinum-Based Chemotherapy
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known if carboplatin is more effective with or without liposomal doxorubicin in treating recurrent ovarian epithelial or primary peritoneal cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of carboplatin with or without liposomal doxorubicin in treating patients who have recurrent ovarian epithelial or primary peritoneal cancer.


Options:
A: Number of Participants With Progression-free Survival Incidence at Week 24 (Week 24)
B: Percentage of Participants With an Overall Response Rate (an average of 126 days for ovarian; 71 days for TNBC; for crossover intervention, pts stayed on study for an avg of 134 days for ovarian; 50 days for TNBC.); Progression Free Survival (Ovarian cancer patients stayed on study for an average of 126 days and triple-negative breast cancer patients for an average of 71 days.)
C: Progression-Free Survival (The timeframe is from enrollment onto the study up to 3 years following enrollment.)
D: overall survival (ten years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Childhood Social Phobia
Brief Summary: This 4-year study will compare the long-term effectiveness of behavioral treatment, fluoxetine (Prozac®), and placebo for treatment of social phobia in children and adolescents.


Options:
A: DSM-IV criteria for Separation Anxiety Disorder (December 2009); Global Success Rating (GSR) (December 2009); Separation Anxiety Inventory for Children (SAI) (December 2009)
B: N/A
C: Clinical Global Impression - Improvement Scale (Measured at Week 12)
D: Score on anxiety diagnostic interview after treatment or waitlist (post-treatment); Score on anxiety rating scale after treatment or waitlist (post-treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Childhood Social Phobia
Brief Summary: This 4-year study will compare the long-term effectiveness of behavioral treatment, fluoxetine (Prozac®), and placebo for treatment of social phobia in children and adolescents.


Options:
A: Evidence of therapy effects on anxiety symptoms are established by assessments of clinical status, symptoms, affective style, sleep,parent-child interactions using rating scales, self-report measures, and behavioral observations. (16 weeks)
B: Anxiety Disorders Interview Schedule for DSM-IV: Parent & Child interview schedule (ADIS/CP). (Change from baseline interview results at 14 weeks); Anxiety Disorders Interview Schedule for DSM-IV: Parent & Child interview schedule (ADIS/CP). (Change from baseline interview results at 3 months)
C: N/A
D: Pediatric Anxiety Rating Scale. (Post-treatment, which is an average of 16 weeks after Baseline)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Bupropion as a Smoking Cessation Aid in Alcoholics
Brief Summary: The purpose of this study is to test the use of time-released bupropion (Wellbutrin) in patients receiving treatment for alcohol abuse/dependence as an aid to stop smoking. Patients will receive either a time-released bupropion or placebo. Both groups will receive nicotine replacement therapy during the 9 week study. A final followup assessment will be conducted 6 months from the start of treatment.


Options:
A: 7 Day Point Prevalence of Cigarette Abstinence (6-month follow up); 7 Day Point Prevalence of Cigarette Abstinence (Week 8)
B: N/A
C: Biochemically-confirmed 7-Day Point-Prevalence Abstinence at 26 Weeks (Assessed 26 weeks after the target quit day.)
D: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Bupropion as a Smoking Cessation Aid in Alcoholics
Brief Summary: The purpose of this study is to test the use of time-released bupropion (Wellbutrin) in patients receiving treatment for alcohol abuse/dependence as an aid to stop smoking. Patients will receive either a time-released bupropion or placebo. Both groups will receive nicotine replacement therapy during the 9 week study. A final followup assessment will be conducted 6 months from the start of treatment.


Options:
A: Tobacco use (Six-month follow-up)
B: Smoking Abstinence (12 months)
C: N/A
D: 7 day point prevalence of cigarette abstinence; measured at Week 13 and on a weekly basis (Weekly, and 13 weeks after beginning study medication (Week 13).)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Bupropion as a Smoking Cessation Aid in Alcoholics
Brief Summary: The purpose of this study is to test the use of time-released bupropion (Wellbutrin) in patients receiving treatment for alcohol abuse/dependence as an aid to stop smoking. Patients will receive either a time-released bupropion or placebo. Both groups will receive nicotine replacement therapy during the 9 week study. A final followup assessment will be conducted 6 months from the start of treatment.


Options:
A: Rating of urges to smoke 1-week after the target quit (1 week)
B: N/A
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: Complete Switching From Combustible Cigarettes to JUUL e-cigarette as measured by Exhaled carbon monoxide (CO) (After 8 weeks); Complete Switching From Combustible Cigarettes to JUUL e-cigarette as measured by change in Total urinary 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) (Baseline, Week 8, Week 12); Complete Switching From Combustible Cigarettes to JUUL e-cigarette as measured by change in self-report of daily cigarette and e-cigarette use (Daily from Week 2 to Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Bupropion as a Smoking Cessation Aid in Alcoholics
Brief Summary: The purpose of this study is to test the use of time-released bupropion (Wellbutrin) in patients receiving treatment for alcohol abuse/dependence as an aid to stop smoking. Patients will receive either a time-released bupropion or placebo. Both groups will receive nicotine replacement therapy during the 9 week study. A final followup assessment will be conducted 6 months from the start of treatment.


Options:
A: Biochemically/pharmacologically-confirmed 12-month continuous abstinence as evidenced by self-reports of nonsmoking status in all interviews (i.e., at 3, 6, and 12 months) (12 months)
B: N/A
C: 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)
D: 7-day Point Prevalence All Tobacco Abstinence (12 weeks - end of treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Bupropion as a Smoking Cessation Aid in Alcoholics
Brief Summary: The purpose of this study is to test the use of time-released bupropion (Wellbutrin) in patients receiving treatment for alcohol abuse/dependence as an aid to stop smoking. Patients will receive either a time-released bupropion or placebo. Both groups will receive nicotine replacement therapy during the 9 week study. A final followup assessment will be conducted 6 months from the start of treatment.


Options:
A: Smoking Cessation at 7 days (7-day point prevalence abstinence); Continuous Smoking Abstinence at 6 weeks (6 weeks)
B: Change in Smoking Behavior (Change in cigarettes per day from Week 2 to Week 5)
C: Number of Participants With a Quit Attempt (6 months)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Switching Antipsychotic Medications
Brief Summary: This study will evaluate the effectiveness of switching medications in decreasing schizophrenia symptoms in individuals who are currently taking an antipsychotic medication for the treatment of schizophrenia.


Options:
A: Evaluate effect on patient weight of adjunctive therapy of aripiprazole with clozapine versus clozapine mono-therapy in schizophrenic patients who are not optimally controlled on clozapine.; The mean change from baseline in patient weight at Week 16 (LOCF) will be compared between the 2 groups.
B: the time the patients remain stable (1 year)
C: Time to Exacerbation of Psychotic Symptoms/Impending Relapse (Baseline of the depot maintenance phase to the end of the study (Week 52))
D: Number Who Discontinued Medication Within First 6 Study Months (Measured at Six Months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Switching Antipsychotic Medications
Brief Summary: This study will evaluate the effectiveness of switching medications in decreasing schizophrenia symptoms in individuals who are currently taking an antipsychotic medication for the treatment of schizophrenia.


Options:
A: Change in the Positive and Negative Syndrome Scale (PANSS) Total Score for Schizophrenia (Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks))
B: Number Who Discontinued Medication Within First 6 Study Months (Measured at Six Months)
C: Time to Relapse (Day 1 to relapse); Time in Remission (Day 1 to last PANSS measurement)
D: The change in the total score of the Positive and Negative Syndrome Scale (PANSS) from the beginning to the end of the double-blind treatment period or to the last post-randomization assessment.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Switching Antipsychotic Medications
Brief Summary: This study will evaluate the effectiveness of switching medications in decreasing schizophrenia symptoms in individuals who are currently taking an antipsychotic medication for the treatment of schizophrenia.


Options:
A: Successful medication discontinuation (4 months)
B: Number of patients with medications discontinued, reduced dose or changed. (baseline, 3, 6 and 12 months); Number of discontinued medications, changed or changing doses. (baseline, 3, 6 and 12 months)
C: Number Who Discontinued Medication Within First 6 Study Months (Measured at Six Months)
D: Medication adherence (One month after patients receive intervention materials)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Switching Antipsychotic Medications
Brief Summary: This study will evaluate the effectiveness of switching medications in decreasing schizophrenia symptoms in individuals who are currently taking an antipsychotic medication for the treatment of schizophrenia.


Options:
A: change from baseline in Positive and Negative Syndrome Scale (PANSS) total scores (The PANSS was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).)
B: 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
C: Risperidone effectiveness is measured by time to relapse within the 52 week period.
D: Number Who Discontinued Medication Within First 6 Study Months (Measured at Six Months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Three-Arm, Multicenter Comparison of 1 Year and 2 Years of Herceptin Versus No Herceptin in Women With HER2-Positive Primary Breast Cancer Who Have Completed Adjuvant Chemotherapy
Brief Summary: The purpose of this trial is to evaluate Herceptin treatment for 1 year and 2 years (versus observation/no Herceptin) in women with HER2-overexpressing primary breast cancer who have completed (neo-)adjuvant systemic chemotherapy, definitive surgery, and radiotherapy, if applicable. Efficacy and safety will be assessed for 10 years from randomization for each participant. All participants will continue to be followed for survival until 10 years after enrollment of the last participant.


Options:
A: Pathologic complete response
B: Percentage of Participants With Disease-Free Survival (DFS) Events in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up (From Baseline until time of event (median of 1 year)); Percentage of Participants With DFS Events in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up (From Baseline until time of event (median of 1 year)); DFS Rate According to Kaplan-Meier Analysis in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up (Year 2); DFS Rate According to Kaplan-Meier Analysis in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up (Year 2); Percentage of Participants With DFS Events Compared to Observation: 8-Year Median Follow-Up (From Baseline until time of event (median of 8 years)); DFS Rate at Year 3 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up (Year 3); DFS Rate at Year 5 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up (Year 5); DFS Rate at Year 7 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up (Year 7); DFS Rate at Year 8 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up (Year 8); Percentage of Participants With DFS Events Compared to Observation: 10-Year Maximum Follow-Up (From Baseline until time of event (maximum of 10 years)); DFS Rate at Year 3 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up (Year 3); DFS Rate at Year 5 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up (Year 5); DFS Rate at Year 7 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up (Year 7); DFS Rate at Year 8 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up (Year 8); DFS Rate at Year 9 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up (Year 9); DFS Rate at Year 10 According to Kaplan-Meier Analysis Compared to Observation: 10-Year Maximum Follow-Up (Year 10)
C: Percentage of Participants With Disease Free Survival at 5 Years (From randomization until relapse or death or up to 5 years)
D: Disease-free survival; Overall survival

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Acute and Continuation Phase Study of the Comparative Efficacy Study of Venlafaxine ER (Effexor® XR) and Fluoxetine (Prozac®) in Achieving and Sustaining Remission (Wellness) in Patients With Recurrent Unipolar Major Depression; Followed by a Long Term Randomized, Placebo-Controlled Maintenance Treatment Study in Patients Treated Initially With Venlafaxine ER
Brief Summary: The purpose of this study is to review the long-term comparative efficacy of venlafaxine ER in achieving and sustaining remission (wellness) in patients with recurrent major depression


Options:
A: Relapse/recurrence of Major Depressive Episode (3, 6, 9, 12, 15 months)
B: N/A
C: Hamilton Rating Scale for Depression (Change from Baseline in HAM-D at 8 weeks)
D: Paid Work Hours at Week 12 (Week 12); Paid Work Hours at Week Baseline (Baseline)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Acute and Continuation Phase Study of the Comparative Efficacy Study of Venlafaxine ER (Effexor® XR) and Fluoxetine (Prozac®) in Achieving and Sustaining Remission (Wellness) in Patients With Recurrent Unipolar Major Depression; Followed by a Long Term Randomized, Placebo-Controlled Maintenance Treatment Study in Patients Treated Initially With Venlafaxine ER
Brief Summary: The purpose of this study is to review the long-term comparative efficacy of venlafaxine ER in achieving and sustaining remission (wellness) in patients with recurrent major depression


Options:
A: Total Discontinuation - Emergent Signs and Symptoms (DESS) Score Over the First 2 Weeks of the Double-blind Phase (Double-blind phase: Week 1 (Study Day 175), Week 2 (Study Day 182))
B: Time to Relapse Following Randomization to the Double-blind (DB) Phase: Estimated Probability (Percent) of Relapse at DB Day 185 (Double-blind phase Baseline (Study Day 140) up to DB Day 185 (Study Day 325))
C: N/A
D: Number of patients who fully discontinued their antidepressant medication after 6 months. (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to evaluate whether zoledronic acid given once yearly for two years to men and women after surgical repair of a recent hip fracture will significantly reduce the rate of all re-occurring (new) osteoporotic fractures. All patients will receive vitamin D and calcium.


Options:
A: Percent change in lumbar spine Bone Mineral Density at Month 12 relative to baseline.
B: Significant reduction in rate of clinical fractures after surgical repair of hip fracture
C: Percentage Change in Lumbar Spine Bone Mineral Density (BMD) at Month 24 Relative to Baseline, by Stratum (Baseline, Month 24)
D: To compare % change in Lumbar Spine BMD from Baseline to Month 24 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic male populations

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to evaluate whether zoledronic acid given once yearly for two years to men and women after surgical repair of a recent hip fracture will significantly reduce the rate of all re-occurring (new) osteoporotic fractures. All patients will receive vitamin D and calcium.


Options:
A: Incidence of hip fxs; Incidence of new vertebral fxs
B: Percent change in lumbar spine Bone Mineral Density at Month 12 relative to baseline.
C: Percentage Change in Lumbar Spine Bone Mineral Density (BMD) at Month 24 Relative to Baseline, by Stratum (Baseline, Month 24)
D: Significant reduction in rate of clinical fractures after surgical repair of hip fracture

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Trial of Concurrent Radiation and Chemotherapy for Advanced Head and Neck Carcinomas
Brief Summary: RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways and combining it with chemotherapy before surgery may kill more tumor cells. It is not yet known which radiation therapy regimen combined with chemotherapy with or without surgery is more effective for head and neck cancer.

PURPOSE: Randomized phase III trial to compare two different radiation therapy regimens combined with cisplatin with or without surgery in treating patients who have stage III or stage IV head and neck cancer.


Options:
A: Survival rate (Up to 5 years)
B: Quality of Life (1-year post treatment)
C: Overall Survival (5 years)
D: Overall Survival (Percentage of Participants Alive) (From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.)

Answer: D