TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Multi-Center Controlled Clinical Trial of Eculizumab in Adolescent Patients With Plasma Therapy-Resistant Atypical Hemolytic Uremic Syndrome (aHUS)
Brief Summary: The purpose of this study is to determine whether eculizumab is safe and effective in the treatment of adolescent patients with plasma therapy-resistant Atypical Hemolytic-Uremic Syndrome (aHUS).


Options:
A: Percentage of Patients With TMA Event-free Status (Through 26 weeks); Percentage of Patients With Hematologic Normalization (Through 26 weeks); Percentage of Patients With Complete TMA Response (Through 26 weeks)
B: Platelet Count Change From Baseline to 26 Weeks (From Baseline to 26 weeks); Percentage of Patients With Platelet Count Normalization (Through 26 weeks); Percentage of Patients With Hematologic Normalization (Through 26 weeks)
C: Percentage of Patients With TMA Event-free Status (Through 26 weeks); Percentage of Patients With Hematologic Normalization (Through 26 weeks); Percentage of Patients With Complete TMA Response (Through 26 weeks)
D: [Safety] Expressed frequency and severity of incidence of AE/SAEs after treatment with investigational product. (6 months); [Efficacy] Proportion of subjects who reach a score of FG2 or lower on the Hughes functional grading scale at week 4（Response Rate） (4 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Study to Assess the Efficacy and Safety of Olanzapine and Fluoxetine Combination Versus Placebo in Patients Ages 10-17 in the Treatment of Major Depressive Episodes Associated With Bipolar I Disorder
Brief Summary: The main goal of this study is to help answer the following research question(s) and not to treat the child's illness.

* Can this study drug make children with bipolar depression feel better?
* Does this study drug work better than a placebo (sugar pill)?
* Does this study drug cause side effects in children who take it?
* Is this drug safe to use in children? (The study drug is a mixture of olanzapine and fluoxetine)


Options:
A: The primary objective is to compare the antidepressant efficacy, safety, and tolerability of DVS-SR in subjects receiving daily doses of 50 mg or 100 mg of DVS SR versus subjects receiving placebo.
B: Change From Baseline in the Children's Depression Rating Scale Revised (CDRS-R) Total Score at Week 8 (Baseline, Week 8)
C: Measured throughout the study: Relapse; Time to relapse
D: Percentage of Participants Experiencing a Treatment Emergent Adverse Event (Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Safety and Efficacy Study of Boceprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Peginterferon/Ribavirin
Brief Summary: Based on previous experience with peginterferon alfa-2b/ribavirin in combination with boceprevir, the combination with peginterferon alfa-

2a/ribavirin and boceprevir is expected to be safe and well tolerated. Given the wide utilization of both peginterferons and the clear benefit of the

addition of boceprevir to peginterferon alfa-2b/ribavirin, it is important to demonstrate the safety and efficacy of boceprevir in combination with

peginterferon alfa-2a/ribavirin.


Options:
A: Sustained Virologic Response (SVR) Rate in Full Analysis Set (FAS) Population. (Follow-up Week 24)
B: Sustained Virological Response (SVR12) (60 weeks)
C: Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks After the End of Treatment (SVR12) (Week 24 (12 weeks after the end of treatment)); Percentage of Participants Experiencing at Least One Adverse Event (Up to Week 14 (14 days after the Blinded Treatment was completed)); Percentage of Participants Discontinued From Study Treatment Because of an Adverse Event (Up to Week 12 (end of Blinded Treatment))
D: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event (Up to 24 weeks)

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 Combination With Peginterferon Alfa-2a and Ribavirin in Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Peginterferon/Ribavirin
Brief Summary: Based on previous experience with peginterferon alfa-2b/ribavirin in combination with boceprevir, the combination with peginterferon alfa-

2a/ribavirin and boceprevir is expected to be safe and well tolerated. Given the wide utilization of both peginterferons and the clear benefit of the

addition of boceprevir to peginterferon alfa-2b/ribavirin, it is important to demonstrate the safety and efficacy of boceprevir in combination with

peginterferon alfa-2a/ribavirin.


Options:
A: Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned (Week 72)
B: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Adverse Events Leading to Permanent Discontinuation of Study Drug(s) (Up to 24 weeks)
C: Percentage of Participants With Virologic Response at Week 12 (End of treatment (EOT) (up to Week 48))
D: Sustained Virologic Response (SVR) Rate in Full Analysis Set (FAS) Population. (Follow-up Week 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Internet- Versus Group-Administered Cognitive Behavior Therapy for Panic Disorder in a Psychiatric Setting: A Randomized Equivalence Trial
Brief Summary: Panic Disorder with or without agoraphobia (PD/A) is a common, and unless it is treated, often chronic psychiatric disorder. The are effective pharmacological as well as psychological treatments for PD/A. Because of the lack of availability of the most effective psychological treatment, cognitive behavior therapy (CBT), self-help based CBT treatments have been developed. One of those are Internet-based CBT. The aim of this study is to compare the effectiveness of Internet and group CBT for PD/A in a regular psychiatric setting. 113 patients are consecutively and randomly assigned to either treatment (both lasting 10 weeks). The main outcome measure is the Panic Disorder Severity Scale(PDSS). The study hypothesis is that treatments will show equal effectiveness.


Options:
A: Panic Disorder Severity Scale (PDSS) (Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment)
B: The Generalised Anxiety Disorder 7-item (GAD-7) (Change from baseline at: [1] day 24 and [2] day 48 into the 10-week treatment period; [3] 0-1 week after the treatment period; follow-ups at [4] month 12 and [5] month 36 after the treatment period.)
C: Change from baseline in Clinical Outcome in Routine Evaluation - Outcome Measure (CORE-OM) (Two weeks pre treatment (baseline), two weeks post treatment, and 12 months post treatment)
D: Panic Disorder Severity Scale (PDSS) (Pre, post at 6-month follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Internet- Versus Group-Administered Cognitive Behavior Therapy for Panic Disorder in a Psychiatric Setting: A Randomized Equivalence Trial
Brief Summary: Panic Disorder with or without agoraphobia (PD/A) is a common, and unless it is treated, often chronic psychiatric disorder. The are effective pharmacological as well as psychological treatments for PD/A. Because of the lack of availability of the most effective psychological treatment, cognitive behavior therapy (CBT), self-help based CBT treatments have been developed. One of those are Internet-based CBT. The aim of this study is to compare the effectiveness of Internet and group CBT for PD/A in a regular psychiatric setting. 113 patients are consecutively and randomly assigned to either treatment (both lasting 10 weeks). The main outcome measure is the Panic Disorder Severity Scale(PDSS). The study hypothesis is that treatments will show equal effectiveness.


Options:
A: Measure of social anxiety and avoidance - Liebowitz Social Anxiety Scale (LSAS) (5-year follow-up)
B: Panic Disorder Severity Scale (PDSS) (Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment)
C: Panic Disorder Severity Scale (PDSS) (Pre, post at 6-month follow-up)
D: Health Anxiety Inventory (3 days before treatment start); Health Anxiety Inventory (12 weeks after pre asessment); Health Anxiety Inventory (6 months after post assessment); Health Anxiety Inventory (12 months after post assessment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIb Multicenter, 52 Week Treatment, Randomized, Blinded, Double Dummy, Parallel Group Efficacy Study Comparing the Effect of Inhaled Indacaterol 150 µg o.d. vs Inhaled Tiotropium 18 µg o.d. on Lung Function, Rate of Exacerbations and Related Outcomes in Patients With COPD
Brief Summary: This study compares indacaterol with tiotropium in terms of bronchodilation over 52 weeks


Options:
A: Aera under curve FEV1 AUC 0-12h (day 1 and 7 of treatment period)
B: Mean Number of Exacerbations Per Year: Negative Binomial Model (Baseline through Week 52); Mean Number of Exacerbations Per Year: Poisson Model (Baseline through Week 52)
C: Trough Forced Expiratory Volume in 1 Second (FEV1). (12 weeks)
D: Annual Rate of Moderate and Severe COPD Exacerbations Expressed as Least Square Mean (From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIb Multicenter, 52 Week Treatment, Randomized, Blinded, Double Dummy, Parallel Group Efficacy Study Comparing the Effect of Inhaled Indacaterol 150 µg o.d. vs Inhaled Tiotropium 18 µg o.d. on Lung Function, Rate of Exacerbations and Related Outcomes in Patients With COPD
Brief Summary: This study compares indacaterol with tiotropium in terms of bronchodilation over 52 weeks


Options:
A: Annual Rate of On-treatment Moderate/Severe Exacerbations Comparing FF/UMEC/VI With UMEC/VI and FF/VI (Up to Week 52)
B: Baseline Pre-bronchodilator FEV1 (L) (Day 1); End-value Pre-bronchodilator FEV1 (L) (Measured at clinic visits: 1, 4, 8 and 12 weeks)
C: Rate of healthcare utilisation based exacerbations of COPD
D: Trough Forced Expiratory Volume in 1 Second (FEV1). (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Local Injury to Endometrium on the Day of Oocyte Retrieval in First IVF Cycle on Implantation Rate.
Brief Summary: Local injury on two sights of endometrium are performed in 60 patients in their first IVF cycle and implantation rate are compared with fresh cycles without local injury.


Options:
A: Clinical pregnancy rate (6 months)
B: Implantation Rate,Chemical pregnancy rate, Clinical pregnancy rate (One year)
C: implantation rate (4 weeks)
D: Live Birth (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Local Injury to Endometrium on the Day of Oocyte Retrieval in First IVF Cycle on Implantation Rate.
Brief Summary: Local injury on two sights of endometrium are performed in 60 patients in their first IVF cycle and implantation rate are compared with fresh cycles without local injury.


Options:
A: ongoing pregnancy rate (1 year)
B: implantation rate (4 weeks)
C: Live Birth (1 year)
D: Participants With Cycle Cancellation Due to Risk of Ovarian Hyperstimulation Syndrome (OHSS) Between Weeks 1 - 3 (weeks 1-3)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Local Injury to Endometrium on the Day of Oocyte Retrieval in First IVF Cycle on Implantation Rate.
Brief Summary: Local injury on two sights of endometrium are performed in 60 patients in their first IVF cycle and implantation rate are compared with fresh cycles without local injury.


Options:
A: improvement in ongoing implantation rates (When a fetal heartbeat is detected for each patient. (8 weeks after implantation).)
B: Delivery rate (2 years)
C: Live Birth (up to 9 months or time of birth)
D: implantation rate (4 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Local Injury to Endometrium on the Day of Oocyte Retrieval in First IVF Cycle on Implantation Rate.
Brief Summary: Local injury on two sights of endometrium are performed in 60 patients in their first IVF cycle and implantation rate are compared with fresh cycles without local injury.


Options:
A: A difference in the term (37 completed weeks of gestation), singleton live birth rate in women undergoing IVF/ICSI treatment following endometrial biopsy versus control subjects. (Approximately 9 months after completion of the last procedure of the last study participant.)
B: Live Birth (1 year)
C: implantation rate (4 weeks)
D: live birth rate (9 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Controlled, Parallel-group, 12-week Study to Compare the Efficacy and Safety of the Combination of Indacaterol 150 µg Once Daily With Open Label Tiotropium 18 µg Once Daily Versus Open Label Tiotropium 18 µg Once Daily in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease
Brief Summary: This study assessed the efficacy and safety of indacaterol (150 µg once daily \[od\]) when combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients with chronic obstructive pulmonary disease (COPD)


Options:
A: Change From Baseline (BL) in 0 to 24 Hour Weighted Mean Serial Forced Expiratory Volume in One Second (FEV1) at Day 84 (Baseline and Day 84)
B: 24-hour Post-dose Trough Forced Expiratory Volume in 1 Second (FEV1) After 14 Days of Treatment (23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 15 of each treatment period)
C: Post-dose TGV(FRC) (After 8 Weeks) (8 weeks); Endurance Time (After 8 Weeks) (8 weeks)
D: Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose at the End of Treatment (Week 12) (From 5 minutes to 8 hours post-dose at the end of treatment (Week 12, Day 84))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Controlled, Parallel-group, 12-week Study to Compare the Efficacy and Safety of the Combination of Indacaterol 150 µg Once Daily With Open Label Tiotropium 18 µg Once Daily Versus Open Label Tiotropium 18 µg Once Daily in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease
Brief Summary: This study assessed the efficacy and safety of indacaterol (150 µg once daily \[od\]) when combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients with chronic obstructive pulmonary disease (COPD)


Options:
A: Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment (after 12 weeks)
B: Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85 (Week 12 + 1 day, Day 85)
C: Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose at the End of the Study (Week 12, Day 84) (From 5 minutes to 8 hours post-dose at the end of the study (Week 12, Day 84))
D: Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose at the End of Treatment (Week 12) (From 5 minutes to 8 hours post-dose at the end of treatment (Week 12, Day 84))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-label, Cross-over Study Comparing Two Vitamin D Supplements for Infants: Liquid Versus D-Strips.
Brief Summary: Vitamin D supplementation (400 IU/d) is recommended for all breastfed infants in Canada. Such recommendation is grounded in the fact that the prevalence of rickets in Canada is higher than desirable, likely due to low maternal-fetal transfer and low intakes postpartum.

There is little data about adherence to supplementation in Canada, but one study shows that in primiparous mothers (n=1937) in Quebec, 58.1 % of those exclusively breast-feeding gave their infant vitamin D supplements in the first six months and 62.1 % of those feeding formula did not. For the Canadian situation, it is not clear if the modality of the supplementation is a barrier to providing the supplement. Thus the overall aim of this study is to test a new delivery system for parental preference and infant acceptance compared to a standard vitamin D supplement.


Options:
A: Number of Laboratory confirmed upper respiratory tract infections (Up to 8 months)
B: XR healing of rickets (6 months)
C: Parental and infant preference for a new vitamin D delivery system over the standard of care supplement in syrup form. (21 days)
D: Bacille-Calmette-Guerin (BCG) vaccine efficacy (2 months); Bacille-Calmette-Guerin (BCG) vaccine efficacy (6 months); Bacille-Calmette-Guerin (BCG) vaccine efficacy (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Collaborative Care Program to Improve Depression Treatment in Cardiac Patients
Brief Summary: Depression in cardiac patients is common, persistent, and deadly. However, the vast majority of cardiac patients with depression go unrecognized and untreated, despite the existence of treatments that clearly improve depressive symptoms and may favorably impact survival. Our research group and others have found that depression recognition and treatment appears particularly limited among patients with acute cardiac illness, though this population may be the most vulnerable to the deleterious effects of depression. We propose a project, building on successful collaborative care depression management programs in outpatient settings, to address this important issue.

The specific hypotheses behind the proposed research are that a collaborative care depression management program can be successfully adapted to inpatient cardiac units, and that such a program will lead to greater rates of adequate depression treatment and improvements in secondary outcomes.

The following specific aims capture the stepwise goals of this program:

1. To determine whether a collaborative care depression management program ('Enhanced Care') leads to significantly increased rates of adequate depression treatment compared to usual care (screening and feedback) (Primary Aim).
2. To assess whether this Enhanced Care program has a lasting impact on adequate depression treatment, depressive symptoms, health-related quality of life, and adherence to medical recommendations at 6 weeks, 12 weeks, and 6 months, compared to usual care.


Options:
A: Rates of Adequate Depression Treatment at Discharge (5 days after enrollment)
B: Reduction in symptoms of major depression (Measured at Months 12, 18, and 24)
C: Neuropsychiatric Inventory; Cornell Depression in Dementia Scale; Activities of Daily Living
D: Adjusted Change in Pain-related Function (Roland Disability Score) (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Collaborative Care Program to Improve Depression Treatment in Cardiac Patients
Brief Summary: Depression in cardiac patients is common, persistent, and deadly. However, the vast majority of cardiac patients with depression go unrecognized and untreated, despite the existence of treatments that clearly improve depressive symptoms and may favorably impact survival. Our research group and others have found that depression recognition and treatment appears particularly limited among patients with acute cardiac illness, though this population may be the most vulnerable to the deleterious effects of depression. We propose a project, building on successful collaborative care depression management programs in outpatient settings, to address this important issue.

The specific hypotheses behind the proposed research are that a collaborative care depression management program can be successfully adapted to inpatient cardiac units, and that such a program will lead to greater rates of adequate depression treatment and improvements in secondary outcomes.

The following specific aims capture the stepwise goals of this program:

1. To determine whether a collaborative care depression management program ('Enhanced Care') leads to significantly increased rates of adequate depression treatment compared to usual care (screening and feedback) (Primary Aim).
2. To assess whether this Enhanced Care program has a lasting impact on adequate depression treatment, depressive symptoms, health-related quality of life, and adherence to medical recommendations at 6 weeks, 12 weeks, and 6 months, compared to usual care.


Options:
A: composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke (every six months for an average of 5.4 years)
B: Re-hospitalization and death rates (Measured at Month 12); Total hospitalizations (Measured at Month 12); HF-specific quality of life (Measured at Months 6 and 12)
C: 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)
D: Rates of Adequate Depression Treatment at Discharge (5 days after enrollment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Masked Clinical Trial of Phacoemulsification Compared With Phacoemulsification and Micro-Bypass Stent Implantation in Patients With POAG
Brief Summary: This was a prospective, double-masked, 15-month clinical trial comparing efficacy of phacoemulsification alone to combined phacoemulsification and implantation of the iStent® trabecular micro-bypass stent in patients with primary open-angle glaucoma.


Options:
A: Change from screening in mean diurnal IOP (mm Hg) at the Month 12 visit. (12 months)
B: Primary outcomes included IOP and reduction in medication use. (15 month)
C: Intraocular Pressure (Measured in mm Hg) Less or Equal to 21 mm Hg on no Topical Hypotensive Meds (12 months)
D: Efficacy (24 months)

Answer: B