TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Framing Messages for Smoking Cessation With Buproprion
Brief Summary: This is a randomized study of message framing in individuals beginning a smoking cessation program utilizing bupropion SR and brief counseling, videos, and pamphlets.


Options:
A: effectiveness (2 years)
B: Days to Relapse (4 weeks)
C: Smoking Cessation at 7 days (7-day point prevalence abstinence); Continuous Smoking Abstinence at 6 weeks (6 weeks)
D: to assess the continuous abstinence from tobacco smoking at every visit during the last four weeks of treatment through direct inquiry of patients; exhaled carbon monoxide testing; and plasma cotinine measurements

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Framing Messages for Smoking Cessation With Buproprion
Brief Summary: This is a randomized study of message framing in individuals beginning a smoking cessation program utilizing bupropion SR and brief counseling, videos, and pamphlets.


Options:
A: continuous abstinence (CAR) from weeks 9 to 12 of treatment (3 months)
B: Smoking Cessation at 7 days (7-day point prevalence abstinence); Continuous Smoking Abstinence at 6 weeks (6 weeks)
C: Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 12 (12 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 24 (24 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 52 (52 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 64 (64 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 104 (104 weeks following treatment initiation)
D: Smoking status at 6 months after enrollment (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Framing Messages for Smoking Cessation With Buproprion
Brief Summary: This is a randomized study of message framing in individuals beginning a smoking cessation program utilizing bupropion SR and brief counseling, videos, and pamphlets.


Options:
A: N/A
B: Smoking Cessation at 7 days (7-day point prevalence abstinence); Continuous Smoking Abstinence at 6 weeks (6 weeks)
C: 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)
D: Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale (1 week)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Framing Messages for Smoking Cessation With Buproprion
Brief Summary: This is a randomized study of message framing in individuals beginning a smoking cessation program utilizing bupropion SR and brief counseling, videos, and pamphlets.


Options:
A: Smoking Abstinence - Serum/Urine Measurements (Week 12); Smoking Abstinence - Number of Cigarettes Smoked (Week 12); Smoking Abstinence - Exhaled Carbon Monoxide (Week 12)
B: N/A
C: Smoking Cessation at 7 days (7-day point prevalence abstinence); Continuous Smoking Abstinence at 6 weeks (6 weeks)
D: The primary outcome measure for alcohol use will be the number of drinks/week at the end of the treatment phase, relative to baseline and during-treatment data. (8 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Framing Messages for Smoking Cessation With Buproprion
Brief Summary: This is a randomized study of message framing in individuals beginning a smoking cessation program utilizing bupropion SR and brief counseling, videos, and pamphlets.


Options:
A: Primary result is percent not using NRT and not smoking at 12 weeks (point prevalence last 7 days) verified by self-declaration combined with a CO < 8 ppm and a p-cotinine < 15 ng/ml (12 weeks +/- 1 week)
B: Percent days abstinent of tobacco, alcohol and drugs (Past 90 days)
C: Change from baseline prevalence of tobacco use at one week and at 2 years [Questionnaire] (One week and Two years after the completion of the intervention)
D: Smoking Cessation at 7 days (7-day point prevalence abstinence); Continuous Smoking Abstinence at 6 weeks (6 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open Label, Active Controlled Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous Bisphosphonates
Brief Summary: The purpose of this trial is to determine the effectiveness of AMG 162 in reducing urinary N-telopeptide in advanced cancer subjects with bone metastases.


Options:
A: Overall survival (1:Not applicable)
B: uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 13 (13 weeks)
C: Time to the First On-Study SRE (Non-inferiority) (Up to 40.5 months)
D: Time to First Skeletal Related Event (Up to 10 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open Label, Active Controlled Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous Bisphosphonates
Brief Summary: The purpose of this trial is to determine the effectiveness of AMG 162 in reducing urinary N-telopeptide in advanced cancer subjects with bone metastases.


Options:
A: Overall survival (1:Not applicable)
B: Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24 (24 months)
C: N/A
D: uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 13 (13 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Phase III Trial Comparing an Association of Hormonal Treatment and Docetaxel Versus the Hormonal Treatment Alone in Metastatic Prostate Cancers
Brief Summary: RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as goserelin, may stop the adrenal glands from making androgens. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving hormone therapy together with docetaxel may be an effective treatment for prostate cancer. It is not yet known whether giving hormone therapy together with docetaxel is more effective than hormone therapy alone in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying hormone therapy and docetaxel to see how well they work compared to hormone therapy alone in treating patients with metastatic prostate cancer.


Options:
A: Radiographic Progression-Free Survival (PFS) (Up to 44 months); Overall Survival (OS) (Up to 66 months)
B: Overall Survival (Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry)
C: Time to treatment failure (TTF)
D: Overall survival at 36 months; Progression-free survival (biological progression and/or clinical progression) at 24 months; Quality of life; Treatment costs; Toxicity and tolerance; Tumor profiles of gene expression as measured by biochips with DNA and tissue microarrays

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) Study: Two Randomized Trials to Compare the Efficacy and Safety of Intravitreal Injection(s) of Triamcinolone Acetonide With Standard Care to Treat Macular Edema
Brief Summary: The SCORE Study will compare the effectiveness and safety of standard care to intravitreal injection(s) of triamcinolone for treating macular edema (swelling of the central part of the retina) associated with central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO).


Options:
A: Visual acuity gain (2 years)
B: Percentage of Patients With a Best Corrected Visual Acuity (BCVA) Improvement of ≥15 Letters From Baseline in the Study Eye (Baseline, Month 39/Final Visit)
C: Percentage of Patients With a Best Corrected Visual Acuity (BCVA) Improvement of ≥15 Letters From Baseline in the Study Eye (Baseline, Month 39/Final Visit)
D: The Number of Study Participants Experiencing an Improvement by 15 or More Letters From Baseline in Best-corrected ETDRS Visual Acuity Score at the 12-month Visit (Change from baseline to 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) Study: Two Randomized Trials to Compare the Efficacy and Safety of Intravitreal Injection(s) of Triamcinolone Acetonide With Standard Care to Treat Macular Edema
Brief Summary: The SCORE Study will compare the effectiveness and safety of standard care to intravitreal injection(s) of triamcinolone for treating macular edema (swelling of the central part of the retina) associated with central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO).


Options:
A: change in central retinal thickness (six months compared to baseline)
B: Best corrected visual acuity (At 12 week); Macular thickness by OCT (At 12 week)
C: N/A
D: The Number of Study Participants Experiencing an Improvement by 15 or More Letters From Baseline in Best-corrected ETDRS Visual Acuity Score at the 12-month Visit (Change from baseline to 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) Study: Two Randomized Trials to Compare the Efficacy and Safety of Intravitreal Injection(s) of Triamcinolone Acetonide With Standard Care to Treat Macular Edema
Brief Summary: The SCORE Study will compare the effectiveness and safety of standard care to intravitreal injection(s) of triamcinolone for treating macular edema (swelling of the central part of the retina) associated with central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO).


Options:
A: Integrity of retinal layers (End of study)
B: N/A
C: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at 6 Months (Baseline and 6 months)
D: The Number of Study Participants Experiencing an Improvement by 15 or More Letters From Baseline in Best-corrected ETDRS Visual Acuity Score at the 12-month Visit (Change from baseline to 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study of Aripiprazole in Patients With Major Depressive Disorder
Brief Summary: The purpose of this 14 week, randomized, double-blind, placebo controlled study is to assess the safety and efficacy of aripiprazole to placebo as adjunctive treatment to an assigned open-label marketed antidepressant therapy (ADT) in patients with Major Depressive Disorder who demonstrate an incomplete response to a prospective eight week trial of the same assigned open-label marketed antidepressant therapy.


Options:
A: MADRS score (weeks 0 (randomization); 8, 9, 10, 12, 14, 16, 18, and 20)
B: N/A
C: Mean Change in the Montgomery Åsberg Depression Rating Scale (MADRS) (Baseline (Week 8) and Week 14)
D: Montgomery and Asberg Scale for Depression (8 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Moderate to Severe Crohn's Disease Who Have Lost Response or Are Intolerant to Infliximab
Brief Summary: The goal of this study is to test whether adalimumab can induce clinical remission in subjects with active Crohn's disease who have been initially treated with infliximab and either lost response or discontinued its use as a result of intolerance to the drug.


Options:
A: Number of Participants Who Achieved Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission Over Time (Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408); Number of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score Over Time (Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408)
B: Induction of clinical remission (CDAI score < 150 at Week 4)
C: Number of Participants Who Had Clinical Remission at Week 52 of Double-blind Treatment (Week 52 of double-blind treatment)
D: Percent of Participants With Clinical Remission as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score ≤ 10 at Week 26 (Week 26)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of EASYcare-based Geriatric Intermediate Care
Brief Summary: The purpose of this study is to study the effects of nursing home visits in independently living elderly people on their functional performance and health-related quality of life. The general practitioner (GP) can refer elderly people to this intervention model after identification of a problem in cognition, mood, behavior, mobility, or nutrition. A specialist geriatric nurse visits the patients at home up to six times and coaches the patient in cooperation with the GP and geriatrician.


Options:
A: Functional performance (independent) activities of daily living measured using Groningen Activity Restriction Scale (3 months); Mental health using subscale mental health MOS-20 (3 months); Informal caregiver burden using Zarit Burden Interview (3 months)
B: Health Care Consumption (1 year); Dependence in Activities of Daily Living (1 year); Satisfaction With Health and Social Care (1 year)
C: Health related quality of life (quality adjusted life years [QALYs]) (baseline, 6 months, 12 months)
D: Overall functioning (18 months); Incremental cost-effectiveness ratio (ICER) (18 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized, Placebo-controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma
Brief Summary: The purpose of the study is: Find out if patients receiving sorafenib will live longer. Find out if sorafenib has any effect on patient reported outcomes. Find out if sorafenib prevents the growth of or shrinks liver tumors and/or their metastases. Determine the pharmacokinetics (PK) in patients with liver cancer.


Options:
A: overall survival (5 years)
B: Time to Progression (TTP). (Patients will be followed over a 2 years period.)
C: Time to Progression (TTP) - Independent Radiological Review (Primary Analysis) (From randomization of the first participant until 28 months later (cut-off date))
D: Overall Survival (OS) (from randomization to death due to any cause until an average 7.2 months later up to the data cut-off date approximately 19 months after start of enrollment); Time to Symptomatic Progression (TTSP) (from randomization to the first documented symptomatic progression until an average 4.8 months later up to the data cut-off date approximately 19 months after start of enrollment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study to Evaluate the Clinical and Microbial Efficacy and Safety of 1.0 % AzaSite Compared to Vehicle in the Treatment of Bacterial Conjunctivitis
Brief Summary: The purpose of this study is to evaluate the clinical and microbial efficacy and safety of AzaSite compared to vehicle for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye may be eligible. Subjects will be randomly assigned to receive either 1.0 % AzaSite or Vehicle. Three visits will be required for this study.


Options:
A: Clinical Cure at the Day 4 (EOT)/Exit Visit (Day 4)
B: Clinical Resolution (Visit 2); Microbial Eradication (Visit 2)
C: Clinical Resolution of Baseline Bacterial Conjunctivitis (Day 5 +/- 1 day); Microbial Eradication of Baseline Bacterial Infection (Day 5 +/- 1 day)
D: Participants Who Achieved Clinical Resolution (Visit 3 (Days 6-7))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study of the Effect of Daily Treatment With MPC-7869 on Measures of Cognition, Activities of Daily Living and Global Function in Subjects With Mild Dementia of the Alzheimer's Type
Brief Summary: The purpose of the study is to evaluate the change in cognitive ability and activities of daily living in patients with Alzheimer's disease (AD) as measured by specific evaluations during 18 months of dosing.


Options:
A: To evaluate the effects of celecoxib in reducing the proportion of subjects with new colorectal adenomas post baseline polypectomy after Month 13 (Year 1) and Month 37 (Year 3) of study drug administration. (3 years)
B: N/A
C: Cognition and activities of daily living (18 mos)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Telemedicine Intervention to Improve Depression Care in Rural CBOCs
Brief Summary: We adapted the collaborative care model using telemedicine (e.g., telephone, interactive video, electronic medical records) to support antidepressant therapy initiated by primary care providers in small rural practices and evaluated the effectiveness and cost-effectiveness of telemedicine-based collaborative care.


Options:
A: Change From Baseline in Glycosylated Hemoglobin (%) (Baseline to 12 months)
B: Geriatric Depression Scale (12 months); Physical Performance Test (PPT) (12 months); SF-36 Health Survey (12 months); Mental Mental Status Exam (MMSE) (12 months); Hospitalization (12 month enrollment period); Hospital Days (12 Month Enrollment Period); Emergency Department Visits (12 month Enrollment Period); Medicare Costs (12 Month Enrollment Period)
C: Medication Appropriateness Index (MAI) score (Change from baseline MAI score at 6 months)
D: 1) Antidepressant prescribing, 2) Medication adherence, 3) Treatment response and remission, 4) Health status and health related quality of life

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Telemedicine Intervention to Improve Depression Care in Rural CBOCs
Brief Summary: We adapted the collaborative care model using telemedicine (e.g., telephone, interactive video, electronic medical records) to support antidepressant therapy initiated by primary care providers in small rural practices and evaluated the effectiveness and cost-effectiveness of telemedicine-based collaborative care.


Options:
A: Percentage of Participants With Depression Treatment Response (6 months)
B: Adherence to Antidepressant Medication (At 3 and 6 months)
C: Number of Patients Who Initiated Hepatitis C Antiviral Treatment Within 12 Months of Enrollment (12 months); Depression Care: Treatment Response (Baseline and 12 months); Depression Care: Depression Remission (Baseline and 12 months); Depression Care: Change From Baseline in Number of Depression Free Days (DFDs) at 12 Months (From Baseline to 12 months)
D: 1) Antidepressant prescribing, 2) Medication adherence, 3) Treatment response and remission, 4) Health status and health related quality of life

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Telemedicine Intervention to Improve Depression Care in Rural CBOCs
Brief Summary: We adapted the collaborative care model using telemedicine (e.g., telephone, interactive video, electronic medical records) to support antidepressant therapy initiated by primary care providers in small rural practices and evaluated the effectiveness and cost-effectiveness of telemedicine-based collaborative care.


Options:
A: Compare the effectiveness of a culturally tailored intervention with the effectiveness of a standard intervention by evaluating its impact on patient outcomes (remission of depression, depression symptom level, functional status) at 6 and 12 months.
B: Rates of Adequate Depression Treatment at Discharge (5 days after enrollment)
C: 1) Antidepressant prescribing, 2) Medication adherence, 3) Treatment response and remission, 4) Health status and health related quality of life
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Study to Lower Veterans Blood Pressure: Patient/Physician Intervention
Brief Summary: This four and a half year trial is evaluating both a patient and a provider intervention in a primary care setting among diagnosed hypertensive veterans. The two primary hypotheses are: 1) the proportion of veterans with BP control who receive either the provider-directed decision support or the patient health education and behavioral intervention will be increased by 10% as compared to usual care; and 2) the proportion of veterans with BP control who receive both the provider-directed decision support and the patient health education and behavioral intervention will be increased by 25% as compared to usual care.


Options:
A: BP control at primary care visit; Systolic and diastolic BPs as recorded at each primary care provider visit during 24 month enrollment period.
B: Physical Function as Measured by Telephone Version of FIM (6-month)
C: Comparison of HbA1c mean between the 3 groups (at 6 months)
D: Number of patients with serious adverse events detected during and at the end of an 18 months follow-up period is compared for the two groups (18 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Study to Lower Veterans Blood Pressure: Patient/Physician Intervention
Brief Summary: This four and a half year trial is evaluating both a patient and a provider intervention in a primary care setting among diagnosed hypertensive veterans. The two primary hypotheses are: 1) the proportion of veterans with BP control who receive either the provider-directed decision support or the patient health education and behavioral intervention will be increased by 10% as compared to usual care; and 2) the proportion of veterans with BP control who receive both the provider-directed decision support and the patient health education and behavioral intervention will be increased by 25% as compared to usual care.


Options:
A: Composite measure of psychological quality of life, composite index of all cause mortality and COPD-related hospitalization. (4 years)
B: Change in Weight (Baseline to 30 months)
C: BP control at primary care visit; Systolic and diastolic BPs as recorded at each primary care provider visit during 24 month enrollment period.
D: Validated 7-day point prevalence tobacco abstinence (6 months after discharge)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Well-being Among Veterans Enhancement Study (WAVES)
Brief Summary: In spite of the impact on veteran�s health status and treatment cost, depression is under-diagnosed and under-treated. The goal of this study is to learn how to implement a previously tested, effective collaborative care model for improving the quality of depression care across multiple Veterans Integrated Service Networks (VISNs). To achieve this goal, we are conducting a randomized controlled trial of evidence-based quality improvement (EBQI), a dissemination method that relies on expert design and local implementation of evidence-based practice interventions. We hypothesize that EBQI will result in increased rates of assessment and appropriate management of depression. Results will be useful in designing realistic chronic care programs and performance measures for continuing care improvement.


Options:
A: At set time points the following will be measured: Recovery from depression Patient quality of life 1 year before and after: Clinic depression treatment utilization and costs
B: Youth functioning (One year)
C: Practice-level colon cancer screening rate (12-months post baseline)
D: Child BMI (3 years)

Answer: A