TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Age-Related Eye Disease Study 2 (AREDS2): A Multi-center, Randomized Trial of Lutein, Zeaxanthin and Omega-3 Long-Chain Polyunsaturated Fatty Acids (Docosahexaenoic Acid [DHA] and Eicosapentaenoic Acid [EPA]) in Age-Related Macular Degeneration
Brief Summary: Oral supplementation with the Age-Related Eye Disease Study (AREDS) formulation (antioxidant vitamins C and E, beta carotene, and zinc) has been shown to reduce the risk of progression to advanced age-related macular degeneration (AMD). Observational data suggest that increased dietary intake of lutein + zeaxanthin (carotenoids), omega-3 long-chain polyunsaturated fatty acids (docosahexaenoic acid \[DHA\] + eicosapentaenoic acid \[EPA\]), or both might further reduce this risk. AREDS2 was designed to test whether adding lutein + zeaxanthin, DHA + EPA, or lutein + zeaxanthin and DHA + EPA to the AREDS formulation might further reduce the risk of progression to advanced AMD. A secondary goal was to test the effects of eliminating beta carotene and reducing zinc dose in the AREDS formulation.


Options:
A: Survival free of atrial fibrillation (12 months)
B: Development of Advanced AMD in People at Moderate to High Risk for Progression. (5 years of follow-up)
C: N/A
D: time to clinical relapse (52 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Age-Related Eye Disease Study 2 (AREDS2): A Multi-center, Randomized Trial of Lutein, Zeaxanthin and Omega-3 Long-Chain Polyunsaturated Fatty Acids (Docosahexaenoic Acid [DHA] and Eicosapentaenoic Acid [EPA]) in Age-Related Macular Degeneration
Brief Summary: Oral supplementation with the Age-Related Eye Disease Study (AREDS) formulation (antioxidant vitamins C and E, beta carotene, and zinc) has been shown to reduce the risk of progression to advanced age-related macular degeneration (AMD). Observational data suggest that increased dietary intake of lutein + zeaxanthin (carotenoids), omega-3 long-chain polyunsaturated fatty acids (docosahexaenoic acid \[DHA\] + eicosapentaenoic acid \[EPA\]), or both might further reduce this risk. AREDS2 was designed to test whether adding lutein + zeaxanthin, DHA + EPA, or lutein + zeaxanthin and DHA + EPA to the AREDS formulation might further reduce the risk of progression to advanced AMD. A secondary goal was to test the effects of eliminating beta carotene and reducing zinc dose in the AREDS formulation.


Options:
A: Percentage of Liver Fat (Baseline and 18 months); Liver Fibrosis Score (Baseline and 18 months); NAFLD Fibrosis Score (Baseline and 18 months)
B: Cumulative incidence of Major depressive Disorder (12 months)
C: Time to first relapse of atrial fibrillation (After a three weeks loading phase)
D: Development of Advanced AMD in People at Moderate to High Risk for Progression. (5 years of follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Age-Related Eye Disease Study 2 (AREDS2): A Multi-center, Randomized Trial of Lutein, Zeaxanthin and Omega-3 Long-Chain Polyunsaturated Fatty Acids (Docosahexaenoic Acid [DHA] and Eicosapentaenoic Acid [EPA]) in Age-Related Macular Degeneration
Brief Summary: Oral supplementation with the Age-Related Eye Disease Study (AREDS) formulation (antioxidant vitamins C and E, beta carotene, and zinc) has been shown to reduce the risk of progression to advanced age-related macular degeneration (AMD). Observational data suggest that increased dietary intake of lutein + zeaxanthin (carotenoids), omega-3 long-chain polyunsaturated fatty acids (docosahexaenoic acid \[DHA\] + eicosapentaenoic acid \[EPA\]), or both might further reduce this risk. AREDS2 was designed to test whether adding lutein + zeaxanthin, DHA + EPA, or lutein + zeaxanthin and DHA + EPA to the AREDS formulation might further reduce the risk of progression to advanced AMD. A secondary goal was to test the effects of eliminating beta carotene and reducing zinc dose in the AREDS formulation.


Options:
A: Development of Advanced AMD in People at Moderate to High Risk for Progression. (5 years of follow-up)
B: Change in body weight (measured at Year 2)
C: Weight loss (1 year)
D: The Primary endpoint will be improvement in a composite score of histological injury as measured by the NASH Activity Score (NAS). (approximately 12 months from enrollment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Age-Related Eye Disease Study 2 (AREDS2): A Multi-center, Randomized Trial of Lutein, Zeaxanthin and Omega-3 Long-Chain Polyunsaturated Fatty Acids (Docosahexaenoic Acid [DHA] and Eicosapentaenoic Acid [EPA]) in Age-Related Macular Degeneration
Brief Summary: Oral supplementation with the Age-Related Eye Disease Study (AREDS) formulation (antioxidant vitamins C and E, beta carotene, and zinc) has been shown to reduce the risk of progression to advanced age-related macular degeneration (AMD). Observational data suggest that increased dietary intake of lutein + zeaxanthin (carotenoids), omega-3 long-chain polyunsaturated fatty acids (docosahexaenoic acid \[DHA\] + eicosapentaenoic acid \[EPA\]), or both might further reduce this risk. AREDS2 was designed to test whether adding lutein + zeaxanthin, DHA + EPA, or lutein + zeaxanthin and DHA + EPA to the AREDS formulation might further reduce the risk of progression to advanced AMD. A secondary goal was to test the effects of eliminating beta carotene and reducing zinc dose in the AREDS formulation.


Options:
A: Development of Advanced AMD in People at Moderate to High Risk for Progression. (5 years of follow-up)
B: N/A
C: The Change in Best-corrected Visual Acuity (BCVA) From Baseline to Year 2 for All Participants. (2 years)
D: Retinal blood flow (in total 8x on 2 study days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Age-Related Eye Disease Study 2 (AREDS2): A Multi-center, Randomized Trial of Lutein, Zeaxanthin and Omega-3 Long-Chain Polyunsaturated Fatty Acids (Docosahexaenoic Acid [DHA] and Eicosapentaenoic Acid [EPA]) in Age-Related Macular Degeneration
Brief Summary: Oral supplementation with the Age-Related Eye Disease Study (AREDS) formulation (antioxidant vitamins C and E, beta carotene, and zinc) has been shown to reduce the risk of progression to advanced age-related macular degeneration (AMD). Observational data suggest that increased dietary intake of lutein + zeaxanthin (carotenoids), omega-3 long-chain polyunsaturated fatty acids (docosahexaenoic acid \[DHA\] + eicosapentaenoic acid \[EPA\]), or both might further reduce this risk. AREDS2 was designed to test whether adding lutein + zeaxanthin, DHA + EPA, or lutein + zeaxanthin and DHA + EPA to the AREDS formulation might further reduce the risk of progression to advanced AMD. A secondary goal was to test the effects of eliminating beta carotene and reducing zinc dose in the AREDS formulation.


Options:
A: COPD exacerbations in the past year over the course of the study (at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year); Airflow obstruction/change in pulmonary function (pre-randomization and after 2 years follow-up); Pneumonia in the past year over the course of the study (at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year)
B: Changes from baseline in global cognitive composite score (2 years); Changes from baseline in macular degeneration (2 years)
C: Cumulative incidence of Major depressive Disorder (12 months)
D: Development of Advanced AMD in People at Moderate to High Risk for Progression. (5 years of follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Age-Related Eye Disease Study 2 (AREDS2): A Multi-center, Randomized Trial of Lutein, Zeaxanthin and Omega-3 Long-Chain Polyunsaturated Fatty Acids (Docosahexaenoic Acid [DHA] and Eicosapentaenoic Acid [EPA]) in Age-Related Macular Degeneration
Brief Summary: Oral supplementation with the Age-Related Eye Disease Study (AREDS) formulation (antioxidant vitamins C and E, beta carotene, and zinc) has been shown to reduce the risk of progression to advanced age-related macular degeneration (AMD). Observational data suggest that increased dietary intake of lutein + zeaxanthin (carotenoids), omega-3 long-chain polyunsaturated fatty acids (docosahexaenoic acid \[DHA\] + eicosapentaenoic acid \[EPA\]), or both might further reduce this risk. AREDS2 was designed to test whether adding lutein + zeaxanthin, DHA + EPA, or lutein + zeaxanthin and DHA + EPA to the AREDS formulation might further reduce the risk of progression to advanced AMD. A secondary goal was to test the effects of eliminating beta carotene and reducing zinc dose in the AREDS formulation.


Options:
A: N/A
B: N/A
C: change in best-corrected visual acuity (6 months)
D: Development of Advanced AMD in People at Moderate to High Risk for Progression. (5 years of follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Cluster Randomised Controlled Trial of the Effect of the Introduction of an Acute Wheeze/Asthma Integrated Care Pathway on Patient Outcome
Brief Summary: Integrated care pathways (ICP) coalesce medical and nursing work practices, unifying and directing care in line with current best practice and guidelines. We wish to examine the introduction of an ICP for children with wheeze/asthma admitted to our hospital. We will determine whether more rigid, but guided care results in faster recovery, quicker discharge with better education and fewer prescribing errors, but also determine whether staff feel alienated by the rigidity of practice, and parents perceive any benefit to the changes introduced.This will be a cluster randomised trial (random weeks) of standard or ICP care in 180 patients admitted to Sick Kids with wheeze/asthma. Parents will be asked to complete a questionnaire on admission and contacted at 10-14 days post discharge and asked to recall education provided at discharge; no other patient or parent intervention will be required.It is expected to take 40 weeks to recruit 180 patients.


Options:
A: Length of stay in hospital
B: Improvement in forced expiratory volume in 1 second [FEV1] within the first 60 minutes after administration (within the first 60 minutes after administration)
C: Improvement in FEV1 (Forced Expiratory Volume in 1 Second) Over the First 60 Minutes After Administration (Baseline and (time weighted average over) 60 Minutes)
D: Reduction in modified pulmonary index score (MPIS) to less than 9 at the end of 4 hours. (4 hours)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Decision Aid for Adult Cystic Fibrosis Patients Considering Bilateral Lung Transplantation
Brief Summary: In 2006, the International Patient Decision Aids Collaboration (IPDAS) reached agreement on criteria for evaluation. Accordingly, the primary outcome is 'decision quality' 3 weeks after using the decision aid. Decision quality is defined as the extent to which a patient decision aid improves the match between the chosen option and the features that matter most to the informed patient. Measures include: a) patients' knowledge of essential facts \[options, benefits, harms, and outcome probabilities\]; and b. the congruence between the option chosen and patients' informed values regarding benefits and risks.

In the past twenty years lung transplantation has become the most widely accepted option of treating cystic fibrosis patients with severe lung disease. Lung transplantation can be a good experience for many patients, improving their quality of life and their survival. However there are potential risks of lung transplantation including infection, organ rejection and early death. Cystic fibrosis patients are often faced with making a choice of whether to be referred for lung transplantation when they are very sick and there is the immediate need to survive. Our group has developed a tool called a decision aid which we hope will assist the patient and family in making this choice. The decision aid guides the patient through a series of steps where they weigh the benefits and risks of being referred for lung transplantation and the benefits and risks of receiving 'usual care' without the option of referral.


Options:
A: The primary outcome involves evaluation of the decision process leading to decision quality as assessed by the Decisional Conflict Scale (DCS). The DCS is a validated scale that has been used in more than 30 PtDA studies across different decisions. (1 Day)
B: Knowledge, realistic expectations and decisional conflict 3 weeks after using the decision aid.
C: Feasibility of subject recruitment; feasibility of delivery of the CHD intervention and surveys in a busy practice setting; feasibility of measuring study outcomes (Measured at the end of the study period (approximately 2 years))
D: Clinical inertia (12 month post intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Decision Aid for Adult Cystic Fibrosis Patients Considering Bilateral Lung Transplantation
Brief Summary: In 2006, the International Patient Decision Aids Collaboration (IPDAS) reached agreement on criteria for evaluation. Accordingly, the primary outcome is 'decision quality' 3 weeks after using the decision aid. Decision quality is defined as the extent to which a patient decision aid improves the match between the chosen option and the features that matter most to the informed patient. Measures include: a) patients' knowledge of essential facts \[options, benefits, harms, and outcome probabilities\]; and b. the congruence between the option chosen and patients' informed values regarding benefits and risks.

In the past twenty years lung transplantation has become the most widely accepted option of treating cystic fibrosis patients with severe lung disease. Lung transplantation can be a good experience for many patients, improving their quality of life and their survival. However there are potential risks of lung transplantation including infection, organ rejection and early death. Cystic fibrosis patients are often faced with making a choice of whether to be referred for lung transplantation when they are very sick and there is the immediate need to survive. Our group has developed a tool called a decision aid which we hope will assist the patient and family in making this choice. The decision aid guides the patient through a series of steps where they weigh the benefits and risks of being referred for lung transplantation and the benefits and risks of receiving 'usual care' without the option of referral.


Options:
A: Knowledge, realistic expectations and decisional conflict 3 weeks after using the decision aid.
B: Health related self-efficacy (8 months)
C: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
D: The primary outcome measure was total medical costs (capped at $200,000 per individual per year) and pharmacy costs.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An International, Multicenter, Randomized, Double-blind, Double-dummy, Parallel Group, Study of 3-month or 6-month Treatment With SSR126517E (3.0 mg s.c. Once-weekly) Versus Oral INR-adjusted Warfarin in the Treatment of Patients With Symptomatic Pulmonary Embolism With or Without Symptomatic Deep Venous Thrombosis
Brief Summary: Objectives are to evaluate whether idrabiotaparinux sodium (SSR126517E) is as least as effective as a standard warfarin treatment to prevent recurrence of venous thromboembolic events (VTE) in patients with symptomatic pulmonary embolism (PE) with or without symptomatic deep venous thrombosis (DVT) and to assess its safety (bleedings) versus warfarin.


Options:
A: Number of Participants With Venous Thromboembolisms and/or Major Hemorrhages to Day 11 (11 days)
B: symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months.
C: Number of Participants With at Least on Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 47 (Baseline to Day 47)
D: Recurrence of symptomatic, fatal or not, VTE (PE or DVT) as confirmed by a Central Independent Adjudication Committee (CIAC) (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An International, Multicenter, Randomized, Double-blind, Double-dummy, Parallel Group, Study of 3-month or 6-month Treatment With SSR126517E (3.0 mg s.c. Once-weekly) Versus Oral INR-adjusted Warfarin in the Treatment of Patients With Symptomatic Pulmonary Embolism With or Without Symptomatic Deep Venous Thrombosis
Brief Summary: Objectives are to evaluate whether idrabiotaparinux sodium (SSR126517E) is as least as effective as a standard warfarin treatment to prevent recurrence of venous thromboembolic events (VTE) in patients with symptomatic pulmonary embolism (PE) with or without symptomatic deep venous thrombosis (DVT) and to assess its safety (bleedings) versus warfarin.


Options:
A: Symptomatic recurrent PE/DVT during the 6-month study treatment period.
B: The Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE) (From Day 1 to Day 90 (±7 days))
C: Recurrence of symptomatic, fatal or not, VTE (PE or DVT) as confirmed by a Central Independent Adjudication Committee (CIAC) (3 months)
D: Graft patency (28 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: ECLIPSE Trial - Ensure's Vascular Closure Device Speeds Hemostasis Trial
Brief Summary: The purpose of this study is to determine whether the Ensure Medical Vascular Closure Device is more effective than standard manual compression at sealing the puncture made in the femoral artery following a cardiac or peripheral diagnostic or interventional procedure while maintaining the same level of safety.


Options:
A: Treatment Success as Defined as the Composite of Procedural Technical Success, Absence of Vascular Complications, and Absence of Major Adverse Events as Determined by the Independent Clinical Events Committee (CEC). (30 days)
B: Time to Hemostasis (TTH) (From when the introducer sheath was removed to the time hemostasis was first observed); Time to Ambulation (TTA) (From when the introducer sheath was removed to 30 days post-procedure); Percentage of Patients Who Experience Any Vascular Closure Related Major Adverse Events During the 30 Days Post-procedure (From post-procedure to 30 days follow up)
C: Composite of arterial access related complications (30 days)
D: Rate of ipsilateral palpable groin hematomas with largest diameter exceeding 5 cm. (20 minutes, 1 hour and at discharge, pooled)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: EValuation Of Cinacalcet Hydrochloride (HCl) Therapy to Lower CardioVascular Events
Brief Summary: The purpose of this study is to evaluate the effects of cinacalcet (cinacalcet HCl or Sensipar®/Mimpara®) on cardiovascular events and death in chronic kidney disease (CKD) patients with secondary hyperparathyroidism (HPT) who are receiving dialysis.


Options:
A: Number of Participants With Mean PTH ≤ 300 pg/mL (Efficacy Assessment Phase (weeks 17 to 23))
B: Proportion of subjects with a mean reduction of greater than or equal to 30% in iPTH at 32 weeks
C: The Number of Participants Who Achieve a Mean Intact Parathyroid Hormone (iPTH) Value Between 150 to 300 pg/mL During the Evaluation Period (Weeks 21 to 28). (Weeks 21 to 28)
D: Time to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitalization for Unstable Angina, Heart Failure or Peripheral Vascular Event) (From date of randomization until date of first confirmed primary composite endpoint event, assessed up to 5.4 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3, Open, Age-stratified Study to Assess Immunogenicity and Safety of GSK Biologicals' HPV-16/18 Vaccine Administered Intramuscularly According to 3-dose Schedule (0,1,6 Months) in Healthy Female Subjects Aged 15 - 55 Years and Long Term Follow-up
Brief Summary: Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. The infection of the cervix by certain oncogenic types of HPV, if not cleared, can lead to cervical cancer in women. This study will evaluate the immunogenicity and safety of the HPV-16/18 L1 VLP AS04 vaccine.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Options:
A: Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) and HPV-18 (One month after third vaccination (Month 7))
B: Number of Subjects Who Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies (At Month 7)
C: HPV-6 Antibody Level (Geometric Mean Titer of HPV-6) (Week 28); HPV-11 Antibody Level (Geometric Mean Titer of HPV-11) (Week 28); HPV-16 Antibody Level (Geometric Mean Titer of HPV-16) (Week 28); HPV-18 Antibody Level (Geometric Mean Titer of HPV-18) (Week 28)
D: Number of Subjects With Injection Site Adverse Experiences (Days 1-5 following any vaccination visit)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Quite Smoking Program for Lung Cancer Patients' Families
Brief Summary: The purpose of this study is to evaluate the impact of delivering a coping-focused intervention as an adjunct to a self-help program to promote smoking cessation among relatives of lung cancer patients.


Options:
A: 7-day point-prevalence abstinence at 2 weeks and 6 month follow-up
B: Treatment Acceptability (6 months); Long-term Point Prevalence Abstinence (PPA; Pilot RCT Phase) (6 months); Short-term Point Prevalence Abstinence (PPA; Pilot RCT Phase) (10 weeks)
C: Smoking Cessation: 7 Day Point Prevalence Abstinence (6 months); Continuous Abstinence From Smoking Since Discharge (6 months); Time to Smoking Relapse (6 months); Time to Smoking Lapse (6 months)
D: 7-Day Point Prevalence Abstinence From Smoking by Intervention (26 weeks after the target quit smoking date); 7-Day Point Prevalence Abstinence From Smoking by Nicotine Replacement Therapy (NRT) Group (26 weeks after the target quit smoking date)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Quite Smoking Program for Lung Cancer Patients' Families
Brief Summary: The purpose of this study is to evaluate the impact of delivering a coping-focused intervention as an adjunct to a self-help program to promote smoking cessation among relatives of lung cancer patients.


Options:
A: Smoking abstinence as measured by 7-day point prevalence abstinence at 12 months following treatment (12 months)
B: 7-day point-prevalence abstinence at 2 weeks and 6 month follow-up
C: N/A
D: 30-day point prevalence tobacco abstinence (6 months); Change in weight (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Quite Smoking Program for Lung Cancer Patients' Families
Brief Summary: The purpose of this study is to evaluate the impact of delivering a coping-focused intervention as an adjunct to a self-help program to promote smoking cessation among relatives of lung cancer patients.


Options:
A: 7-day point-prevalence abstinence at 2 weeks and 6 month follow-up
B: Reduction in number of cigarettes smoked as measured by the Timeline Follow-back. (Baseline, Pre Counseling Sessions 1-5, Weeks 8, 12, 24)
C: Quit Attempt(s) (Any time within 26 weeks)
D: smoking abstinence: self reported abstinence (12 or more months) (12 months)

Answer: A