TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Randomized, Controlled Arm Study Comparing the Coverage of the Zotarolimus-eluting Stent vs Bare Metal Stent Implanted in ST- Elevation Myocardial Infarction (STEMI).
Brief Summary: The objective of this study is to evaluate the completeness of struts coverage and vessel wall response (strut malapposition, neointima disomogeneities in texture) to the ENDEAVOR drug-eluting stent vs the DRIVER stent (bare metal stent of identical metallic platform) implanted for the treatment of the culprit lesion in ST-elevation acute myocardial infarction (STEMI). To investigate the completeness of the coverage as well as the number of uncovered stent struts per section (embedded, uncovered, malapposed) and the neointima texture, high resolution (\~ 10-15 µm axial) intracoronary optical coherence tomography (OCT)will be used.


Options:
A: Pharmacology Arm - Major Adverse Ischemic Cardiac Events and Major Bleeding Events (30 Days); Stent Arm - Ischemic Target Lesion Revascularization (1 year); Stent Arm - Death, Reinfarction, Stroke, or Stent Thrombosis (1 year)
B: to determine the efficacy of paclitaxel eluting stent compared to conventional bare stent in terms of restenosis (12 months); to determine the effect of tirofiban administered prior to PCI but 120 minutes after thrombolytic on the epicardial and myocardial flow after mechanical revascularization in patients with STEMI (24 hours)
C: Non inferiority OCT Number of uncovered Stent struts for Endeavor drug eluting stent vs Driver BMSbare metal stent (6 months)
D: The evaluation of the degree of ST-segment resolution after the mechanical intervention. (90 minutes after last balloon inflation); The cumulative rate of death for any cause, reinfarction and target vessel revascularisation (8 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-week, Open Label, Multicenter, Titration Study, With a 12 Month Extension, to Determine the Optimal Titration Regimen for SBR759, Compared to Sevelamer HCl, in Lowering Serum Phosphate Levels in Asian Patients With Chronic Kidney Disease on Hemodialysis
Brief Summary: This study will determine the titration regimen for SBR759 compared to sevelamer HCl in lowering serum phosphate levels in Asian Chronic Kidney Disease patients on hemodialysis


Options:
A: Correlation between fasting salivary phosphorus and estimated glomerular filtration rate (single value between 7-11 am); Correlation between post meal salivary phosphorus and estimated glomerular filtration rate (single value after meal between 1-4 pm)
B: Natural Logarithm Transformed Serum Intact Fibroblast Growth Factor (FGF-23) Levels at Week 12 Last Observation Carried Forward (LOCF) (12 Weeks)
C: Responder rates achieving target serum phosphate levels. (Week 12)
D: Change in serum phosphorus (4 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Using Video Images in Dementia
Brief Summary: BACKGROUND: Advance care planning (ACP) is the process in which patients plan for future medical care under circumstances of impaired decision-making. Video is an underutilized medium that can assist clinicians in discussions of future health states, such as the state of advanced dementia. Video may enable patients to visualize the future by concisely providing complex information vital for ACP. This study will examine whether the use of video could facilitate a more comprehensive understanding of advanced dementia and inform clinician-patient discussions about the level of care a patient would want in the event of advanced dementia.

RESEARCH PLAN: We propose to conduct a randomized trial studying ACP for 200 elderly subjects using a video depiction of a patient with dementia compared to the traditional verbal narrative. Specific aims 1 and 2 assess the effect of a video of advanced dementia on the clinical decision making of elderly subjects compared to the traditional verbal narrative.


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: Receipt of colorectal cancer screening exam (fecal occult blood test, flexible sigmoidoscopy, or colonoscopy) within 4 months following delivery of an electronic message within the personal health record
C: Clinical inertia (12 month post intervention)
D: preferences (at time of interview)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Hyperandrogenism vs. Insulin Resistance in Infertile PCOS Women
Brief Summary: The goal of this three-armed randomized controlled trial is to establish the relative roles of treatment of hyperandrogenism versus obesity (as the largest modifiable factor contributing to insulin resistance) in treating infertility and improving pregnancy outcomes among obese PCOS women. The investigators hypothesize that the key to restoring ovulation leading to live birth is to correct hyperandrogenism with oral contraceptive pills, but the key to avoiding later pregnancy complications is to improve insulin sensitivity with weight loss.


Options:
A: Live Birth Rate (Participants were followed for 4 months of attempted conception and those who conceived were then followed for the duration of their pregnancy, approximately 9 months.)
B: insulin resistance (10 weeks)
C: Pregnancy rate (six months)
D: change of BMI-SDS (20 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Families First Edmonton: The Comparative Effects and Expense of Four Models of Augmenting Services for Low-income Families
Brief Summary: This study is designed to provide clear evidence for health and social policymakers about the influence of alternate service-delivery models and practices on enhancing and sustaining low-income family linkages to available services. A challenge faced by Canadian health and social service providers is to promote health for low-income families in a proactive and cost-effective manner. Families with low incomes experience an array of health and social barriers that compromise their resilience, lead to negative family outcomes, and act as barriers to available services. Family barriers are compounded by service delivery barriers and result in reduced opportunities for effective, primary-level services and in increased use of secondary-level services (e.g., emergency room visits, emergency intervention, police involvement), with the obvious increase in costs. Randomized-controlled trials are rare in community-based intervention research.

This Families First Edmonton randomized-controlled trial (RCT) will enable testing of innovative service-delivery models and provide an opportunity for evidence-based decision making for Canadian policy makers. Critical information will be provided about

1. optimizing cost effectiveness for public systems
2. the long-term effects on the health of low-income family members
3. mechanisms that intervene between the interventions and their effect on the health of low-income family members
4. building on previous research and on community-based initiatives
5. promoting knowledge transfer


Options:
A: Frequency of Evidence Based Strategies (Discharge or 7 days after admission); Composite Adherence Score (Discharge or 7 days after admission)
B: Change in Child Body Mass Index (BMI) Z-score (Post intervention (9 months after baseline))
C: Referral for Kidney Transplantation (One Year)
D: Increased linkages between low income families and established services in their communities (Baseline, 12-month, 24-month, 36-month follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Safety and Efficacy Study of Boceprevir in Previously Untreated Subjects With Chronic Hepatitis C Genotype 1
Brief Summary: This study involves treatment with boceprevir or placebo in combination with PegIntron (PEG) + Ribavirin (RBV) (weight-based dosing \[WBD\]) in previously untreated adult participants with chronic hepatitis C (CHC) genotype 1. It is hypothesized that the addition of a third active anti- Hepatitis C Virus (anti-HCV) drug may lead to more rapid viral response than therapy with two drugs, and therefore, the addition of boceprevir to PegIntron plus ribavirin therapy after a 4-week lead-in period may allow for both increased rates of sustained virologic response (SVR) and shorter treatment durations (in some populations) than treatment with PegIntron plus ribavirin alone.

The study includes two separate cohorts, Cohort I (White participants) and Cohort II (Black participants). Participants from each cohort are assigned (randomized) to one of three study arms, all of which have a 4-week lead-in period with (PEG + RBV).


Options:
A: The Percentage of Participants Achieving a Sustained Virologic Response at the End of Treatment (EOT) and 24 Weeks After the EOT (SVR24) (Week 72)
B: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Noninferiority Analyses of Each Treatment Arm Compared to Historical Rate (12 weeks after last dose of study drug)
C: Proportion of treated subjects in each of the naive arms with sustained virologic response (SVR12) (Post treatment 12 week)
D: Sustained Virologic Response (SVR) Rate (At Follow-up Week (FW) 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Safety and Efficacy Study of Boceprevir in Previously Untreated Subjects With Chronic Hepatitis C Genotype 1
Brief Summary: This study involves treatment with boceprevir or placebo in combination with PegIntron (PEG) + Ribavirin (RBV) (weight-based dosing \[WBD\]) in previously untreated adult participants with chronic hepatitis C (CHC) genotype 1. It is hypothesized that the addition of a third active anti- Hepatitis C Virus (anti-HCV) drug may lead to more rapid viral response than therapy with two drugs, and therefore, the addition of boceprevir to PegIntron plus ribavirin therapy after a 4-week lead-in period may allow for both increased rates of sustained virologic response (SVR) and shorter treatment durations (in some populations) than treatment with PegIntron plus ribavirin alone.

The study includes two separate cohorts, Cohort I (White participants) and Cohort II (Black participants). Participants from each cohort are assigned (randomized) to one of three study arms, all of which have a 4-week lead-in period with (PEG + RBV).


Options:
A: Sustained Virologic Response (SVR) Rate (At Follow-up Week (FW) 24)
B: Sustained virologic response (SVR) at 12 weeks post-treatment (SVR12) (12 weeks post-treatment)
C: Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24) (Post-treatment Week 24); Percentage of Participants Who Experienced Adverse Events (Baseline (Day 1) to post-treatment Day 30)
D: Proportion of Randomized Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Dose of Study Treatment (SVR24) (24 weeks after the last planned dose of study treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Safety and Efficacy Study of Boceprevir in Previously Untreated Subjects With Chronic Hepatitis C Genotype 1
Brief Summary: This study involves treatment with boceprevir or placebo in combination with PegIntron (PEG) + Ribavirin (RBV) (weight-based dosing \[WBD\]) in previously untreated adult participants with chronic hepatitis C (CHC) genotype 1. It is hypothesized that the addition of a third active anti- Hepatitis C Virus (anti-HCV) drug may lead to more rapid viral response than therapy with two drugs, and therefore, the addition of boceprevir to PegIntron plus ribavirin therapy after a 4-week lead-in period may allow for both increased rates of sustained virologic response (SVR) and shorter treatment durations (in some populations) than treatment with PegIntron plus ribavirin alone.

The study includes two separate cohorts, Cohort I (White participants) and Cohort II (Black participants). Participants from each cohort are assigned (randomized) to one of three study arms, all of which have a 4-week lead-in period with (PEG + RBV).


Options:
A: Sustained Virologic Response (SVR) Rate (At Follow-up Week (FW) 24)
B: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) (Baseline to Week 12)
C: N/A
D: Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned (Week 72)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Safety and Efficacy Study of Boceprevir in Previously Untreated Subjects With Chronic Hepatitis C Genotype 1
Brief Summary: This study involves treatment with boceprevir or placebo in combination with PegIntron (PEG) + Ribavirin (RBV) (weight-based dosing \[WBD\]) in previously untreated adult participants with chronic hepatitis C (CHC) genotype 1. It is hypothesized that the addition of a third active anti- Hepatitis C Virus (anti-HCV) drug may lead to more rapid viral response than therapy with two drugs, and therefore, the addition of boceprevir to PegIntron plus ribavirin therapy after a 4-week lead-in period may allow for both increased rates of sustained virologic response (SVR) and shorter treatment durations (in some populations) than treatment with PegIntron plus ribavirin alone.

The study includes two separate cohorts, Cohort I (White participants) and Cohort II (Black participants). Participants from each cohort are assigned (randomized) to one of three study arms, all of which have a 4-week lead-in period with (PEG + RBV).


Options:
A: Proportion of Randomized Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Dose of Study Treatment (SVR24) (24 weeks after the last planned dose of study treatment)
B: Number of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels 24 Weeks After Last Planned Dose of Study Treatment (24 weeks after last planned dose of study treatment (up to Week 72))
C: Sustained Virologic Response (SVR) Rate (At Follow-up Week (FW) 24)
D: Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned (Week 72)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Safety and Efficacy Study of Boceprevir in Previously Untreated Subjects With Chronic Hepatitis C Genotype 1
Brief Summary: This study involves treatment with boceprevir or placebo in combination with PegIntron (PEG) + Ribavirin (RBV) (weight-based dosing \[WBD\]) in previously untreated adult participants with chronic hepatitis C (CHC) genotype 1. It is hypothesized that the addition of a third active anti- Hepatitis C Virus (anti-HCV) drug may lead to more rapid viral response than therapy with two drugs, and therefore, the addition of boceprevir to PegIntron plus ribavirin therapy after a 4-week lead-in period may allow for both increased rates of sustained virologic response (SVR) and shorter treatment durations (in some populations) than treatment with PegIntron plus ribavirin alone.

The study includes two separate cohorts, Cohort I (White participants) and Cohort II (Black participants). Participants from each cohort are assigned (randomized) to one of three study arms, all of which have a 4-week lead-in period with (PEG + RBV).


Options:
A: Sustained Virologic Response (SVR) Rate (At Follow-up Week (FW) 24)
B: Safety Outcome Measures (Safety and tolerability assessments will be performed for a period of 7 days after administration of a single dose)
C: Percentage of Participants With Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12) (12 Weeks After the Planned End of Treatment (EOT: Week 48))
D: Percentage of Participants Achieving Sustained Virologic Response (SVR)12 (Posttreatment Week 12); Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug (Baseline to Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Safety and Efficacy Study of Boceprevir in Previously Untreated Subjects With Chronic Hepatitis C Genotype 1
Brief Summary: This study involves treatment with boceprevir or placebo in combination with PegIntron (PEG) + Ribavirin (RBV) (weight-based dosing \[WBD\]) in previously untreated adult participants with chronic hepatitis C (CHC) genotype 1. It is hypothesized that the addition of a third active anti- Hepatitis C Virus (anti-HCV) drug may lead to more rapid viral response than therapy with two drugs, and therefore, the addition of boceprevir to PegIntron plus ribavirin therapy after a 4-week lead-in period may allow for both increased rates of sustained virologic response (SVR) and shorter treatment durations (in some populations) than treatment with PegIntron plus ribavirin alone.

The study includes two separate cohorts, Cohort I (White participants) and Cohort II (Black participants). Participants from each cohort are assigned (randomized) to one of three study arms, all of which have a 4-week lead-in period with (PEG + RBV).


Options:
A: Progression of Liver Disease as Indicated by Death, Hepatic Decompensation, Hepatocellular Carcinoma, or for Patients With Noncirrhotic Fibrosis at Baseline, an Increase in the Ishak Hepatic Fibrosis Score of 2 or More Points (1400 days (3.85 years) post randomization); Increase in Ishak Fibrosis Score by 2 Points or More at 2 or 4 Year Biopsies (1400 days (3.85 years) post randomization); Death From Any Cause (1400 days (3.85 years) post randomization); Development of Hepatocellular Carcinoma (HCC) (1400 days (3.85 years) post randomization); Child-Turcotte-Pugh (CTP) Score of 7 or Higher at Two Consecutive Study Visits (1400 days (3.85 years) post randomization); Variceal Hemorrhage (1400 days (3.85 years) post randomization); Ascites (1400 days (3.85 years) post randomization); Spontaneous Bacterial Peritonitis (1400 days (3.85 years) post randomization); Hepatic Encephalopathy (1400 days (3.85 years) post randomization)
B: Time to Observation of the First Clinical Event Experienced by a Subject (Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event)
C: Number of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels 24 Weeks After Last Planned Dose of Study Treatment (24 weeks after last planned dose of study treatment (up to Week 72))
D: Sustained Virologic Response (SVR) Rate (At Follow-up Week (FW) 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Cluster Randomized Controlled Evaluation of the Impact of Zinc and / or Micronutrient Supplementation on Intestinal Flora, Diarrheal Disease Burden, Intestinal Mucosal Integrity and Growth Among Cohorts of Children in Pakistan
Brief Summary: Information on the mechanisms of zinc is still in developing phase. Ecological and biological implications of long term zinc supplementation at population level requires assessment. The trial aims to assess the impact of routine supplementation of zinc among young growing children and evaluate its impact on intestinal microbial flora and relationship with gut mucosa integrity and co-morbidities.


Options:
A: Episodes of Diarrhea and additional morbidity such as acute lower respiratory tract infection, pneumonia and days with severe illness. (2 years)
B: Change in length and length-for-age Z-score (36 weeks); Change in weight and weight-for-age Z-score (36 weeks); Incidence of diarrhea (36 weeks); Change in hemoglobin concentration (32 weeks); Change in micronutrient status (32 weeks); Innate and adaptive immune defense (32 weeks)
C: Hemoglobin concentration (End of the 30-day fortification period)
D: Proportion of children with Weight-for-height and/or Height-for-age ZScore <-2 (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Cluster Randomized Controlled Evaluation of the Impact of Zinc and / or Micronutrient Supplementation on Intestinal Flora, Diarrheal Disease Burden, Intestinal Mucosal Integrity and Growth Among Cohorts of Children in Pakistan
Brief Summary: Information on the mechanisms of zinc is still in developing phase. Ecological and biological implications of long term zinc supplementation at population level requires assessment. The trial aims to assess the impact of routine supplementation of zinc among young growing children and evaluate its impact on intestinal microbial flora and relationship with gut mucosa integrity and co-morbidities.


Options:
A: Perinatal mortality, i.e., the number of stillbirths (fetal deaths of 28 weeks or more of gestation) and the number of deaths within the first 0-6 days of life per 1000 births (live births and stillbirths) (20 weeks gestation to 6 days postpartum)
B: Episodes of Diarrhea and additional morbidity such as acute lower respiratory tract infection, pneumonia and days with severe illness. (2 years)
C: Hemoglobin (February 2007-February 2008)
D: Frequency of Consumption of the Calcium Vehicle (Change from Baseline in Consumption of the Calcium Vehicle at day 22)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Cluster Randomized Controlled Evaluation of the Impact of Zinc and / or Micronutrient Supplementation on Intestinal Flora, Diarrheal Disease Burden, Intestinal Mucosal Integrity and Growth Among Cohorts of Children in Pakistan
Brief Summary: Information on the mechanisms of zinc is still in developing phase. Ecological and biological implications of long term zinc supplementation at population level requires assessment. The trial aims to assess the impact of routine supplementation of zinc among young growing children and evaluate its impact on intestinal microbial flora and relationship with gut mucosa integrity and co-morbidities.


Options:
A: Episodes of Diarrhea and additional morbidity such as acute lower respiratory tract infection, pneumonia and days with severe illness. (2 years)
B: Stunting-reduction in stunted children in intervention group (2 Years)
C: Product sales and use (coverage) (Every 2 weeks)
D: gut microbiota composition (Fecal sample after 2 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Cluster Randomized Controlled Evaluation of the Impact of Zinc and / or Micronutrient Supplementation on Intestinal Flora, Diarrheal Disease Burden, Intestinal Mucosal Integrity and Growth Among Cohorts of Children in Pakistan
Brief Summary: Information on the mechanisms of zinc is still in developing phase. Ecological and biological implications of long term zinc supplementation at population level requires assessment. The trial aims to assess the impact of routine supplementation of zinc among young growing children and evaluate its impact on intestinal microbial flora and relationship with gut mucosa integrity and co-morbidities.


Options:
A: Change in Length for Age (Once per month for 6 months, then once after 12 months.)
B: L:M ratio at 1.5 months (1.5 months)
C: Episodes of Diarrhea and additional morbidity such as acute lower respiratory tract infection, pneumonia and days with severe illness. (2 years)
D: The mean number of episodes and duration of acute diarrheal disease (24 weeks)

Answer: C