TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Role Of Omega-3 Fatty Acids In Adolescent Depression
Brief Summary: The purpose of this study is to examine the effects of a 10-week Omega-3 Fatty Acid treatment phase on brain chemistry of adolescents with major depressive disorder (MDD) using proton magnetic resonance imaging.


Options:
A: Serum Fasting Blood Sugar(FBS) (Change from baseline at 10 weeks)
B: Depression rating scale score on HAM-D 17, SCID Mood Module (Both measured at Week 8)
C: ACC Glx/Water (baseline and 10-weeks); ACC GABA/Water (baseline and 10-weeks)
D: Major cardiovascular events, which comprises fatal cardiovascular diseases (CVD), non-fatal myocardial infarction, non-fatal cardiac arrest, non-fatal stroke and cardiac interventions (PCI and CABG) (monitored during intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The European Quality of Care Pathways Study: The Impact of a Care Pathway for Proximal Femur Fracture (PFF) : an International Cluster Randomized Controlled Trial." (Www.E-P-A.Org)
Brief Summary: Care pathways, a complex intervention to (re)organise, standardize and evaluate care processes, are used worldwide and in different kinds of settings. Although their international use, the impact is unclear. The European Quality of Care Pathways Study is the first international cluster Randomized Controlled Trial on the effect of care pathways for proximal femur fracture patients (PFF).

The hypothesis is that teams who work with care pathways for PFF patients deliver care that is more compliant to evidence based key interventions, have better patient outcomes and higher scores on team indicators than teams who do not work with care pathways.


Options:
A: Change in the performance-based Short physical performance battery (SPPB) (Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery)
B: Montebello Rehabilitation Factor Score (MRFS) (1 day At discharge); Montebello Rehabilitation Factor Score (MRFS) (At 6 months); Montebello Rehabilitation Factor Score (MRFS) (At 1 year); Proportions of patients achieving pre-morbid ambulatory status (1 day At discharge); Proportions of patients achieving pre-morbid ambulatory status (At 6 months); Proportions of patients achieving pre-morbid ambulatory status (At 1 year); Length of stay in hospital (1 day At discharge); Percentage of patients admitted to nursing home (Up to 1 year after discharge)
C: Mortality (6 month)
D: Quality of life (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Transfers of Fresh and Thawed Embryos in High Responder Patients
Brief Summary: This study tests the hypothesis that controlled ovarian stimulation impairs endometrial receptivity in high responders.


Options:
A: cumulative live birth rate of a single PGD treatment (1 year)
B: Pregnancy rate (8 weeks after inclusion)
C: Clinical pregnancy (fetal heartbeat observed on ultrasound at 7 weeks gestation) (7 weeks gestation)
D: Ongoing pregnancy rates (Two years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Transfers of Fresh and Thawed Embryos in High Responder Patients
Brief Summary: This study tests the hypothesis that controlled ovarian stimulation impairs endometrial receptivity in high responders.


Options:
A: Ongoing pregnancy (12 weeks of gestation)
B: Clinical pregnancy (fetal heartbeat observed on ultrasound at 7 weeks gestation) (7 weeks gestation)
C: Clinical pregnancy (fetal heartbeat observed on ultrasound at 7 weeks gestation) (7 weeks gestation)
D: Clinical pregnancy rates (7 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Transfers of Fresh and Thawed Embryos in High Responder Patients
Brief Summary: This study tests the hypothesis that controlled ovarian stimulation impairs endometrial receptivity in high responders.


Options:
A: live birth rate (10 months for group A, 12 months for group B)
B: Percentage of Participants With ≥1 Vital Pregnancy (Cumulative Vital Pregnancy Rate) (Assessed at least 35 days after ET in COS cycle in Base Study P06029 or an FTET cycle in Follow-Up Study P06031 (up to 2 years))
C: implantation rate (4 weeks)
D: Clinical pregnancy (fetal heartbeat observed on ultrasound at 7 weeks gestation) (7 weeks gestation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Transfers of Fresh and Thawed Embryos in Normal Responder Patients
Brief Summary: This study tests the hypothesis that controlled ovarian stimulation impairs endometrial receptivity in normal responders.


Options:
A: Clinical pregnancy (fetal heartbeat observed on ultrasound at 7 weeks gestation) (7 weeks gestation)
B: live birth rate (10 months for group A, 12 months for group B)
C: Pregnancy rate (8 weeks after inclusion)
D: Ongoing pregnancy rates (Two years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Transfers of Fresh and Thawed Embryos in Normal Responder Patients
Brief Summary: This study tests the hypothesis that controlled ovarian stimulation impairs endometrial receptivity in normal responders.


Options:
A: Clinical pregnancy rates (7 weeks)
B: Clinical pregnancy (fetal heartbeat observed on ultrasound at 7 weeks gestation) (7 weeks gestation)
C: Percentage of Participants With ≥1 Vital Pregnancy (Cumulative Vital Pregnancy Rate) (Assessed at least 35 days after ET in COS cycle in Base Study P06029 or an FTET cycle in Follow-Up Study P06031 (up to 2 years))
D: Clinical pregnancy (fetal heartbeat observed on ultrasound at 7 weeks gestation) (7 weeks gestation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Transfers of Fresh and Thawed Embryos in Normal Responder Patients
Brief Summary: This study tests the hypothesis that controlled ovarian stimulation impairs endometrial receptivity in normal responders.


Options:
A: live birth rate (10 months for group A, 12 months for group B)
B: Clinical pregnancy (fetal heartbeat observed on ultrasound at 7 weeks gestation) (7 weeks gestation)
C: Clinical pregnancy (fetal heartbeat observed on ultrasound at 7 weeks gestation) (7 weeks gestation)
D: Percentage of Participants With ≥1 Vital Pregnancy (Cumulative Vital Pregnancy Rate) (Assessed at least 35 days after ET in COS cycle in Base Study P06029 or an FTET cycle in Follow-Up Study P06031 (up to 2 years))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Partially-blind Study on the Safety, Tolerability and Effect on Virological Response of Treatment With the HCV Protease Inhibitor RO5190591 in Combination With Pegasys and Copegus, Versus Pegasys and Copegus Alone, in Treatment-Naïve Patients With Hepatitis C Genotype 1 Virus Infectio
Brief Summary: This 2 part study will evaluate the efficacy and safety of 12 and 24 weeks treatment with RO5190591 (danoprevir) in combination with Pegasys and Copegus, compared to Pegasys and Copegus alone, in treatment-naive patients with chronic hepatitis C genotype 1 virus infection.In Part 1 of the study, patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours, 2) RO5190591 600mg po every 12 hours, 3) RO5190591 900mg po every 12 hours or 4) placebo, in combination with standard doses of Pegasys and Copegus. If the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours or 600mg po every 12 hours or 900mg po every 12 hours or 2)placebo, in combination with standard doses of Pegasys and Copegus. The anticipated time on study treatment is 24-48 weeks, and the target sample size is 100-500 individuals.


Options:
A: Phase 2a and Phase 2b: Safety, as measured by the frequency of SAEs and discontinuations due to AEs (12 weeks after first dose); Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA (Week 4); Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA (Week 12); Phase 2b only: Antiviral activity, as determined by the proportion of HCV genotype 1 subjects with 24-week sustained virologic response (SVR24), defined as undetectable HCV RNA (at follow-up Week 24)
B: Sustained virological response (24 weeks after end of treatment)
C: Percentage of Participants in Arms A, B and C With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) (12 weeks after the last actual dose of study drug)
D: Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12) (Post-treatment Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Partially-blind Study on the Safety, Tolerability and Effect on Virological Response of Treatment With the HCV Protease Inhibitor RO5190591 in Combination With Pegasys and Copegus, Versus Pegasys and Copegus Alone, in Treatment-Naïve Patients With Hepatitis C Genotype 1 Virus Infectio
Brief Summary: This 2 part study will evaluate the efficacy and safety of 12 and 24 weeks treatment with RO5190591 (danoprevir) in combination with Pegasys and Copegus, compared to Pegasys and Copegus alone, in treatment-naive patients with chronic hepatitis C genotype 1 virus infection.In Part 1 of the study, patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours, 2) RO5190591 600mg po every 12 hours, 3) RO5190591 900mg po every 12 hours or 4) placebo, in combination with standard doses of Pegasys and Copegus. If the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours or 600mg po every 12 hours or 900mg po every 12 hours or 2)placebo, in combination with standard doses of Pegasys and Copegus. The anticipated time on study treatment is 24-48 weeks, and the target sample size is 100-500 individuals.


Options:
A: Proportion of treated subjects with SVR12, defined as HCV RNA < LOQ at post treatment Week 12, for subjects who are prior null or partial responders to P/R or are treatment-naive (At 12 weeks post-treatment)
B: Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment-Naïve HCV-Infected Participants (Cohort 1 and 2, Panel A) (Week 4); Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment-Naïve HCV-Infected Participants (Cohort 1 and 2, Panel B) (Week 4); Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment-Experienced HCV-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D) (Week 4)
C: The Percentage of Participants Achieving a Sustained Virologic Response at the End of Treatment (EOT) and 24 Weeks After the EOT (SVR24) (Week 72)
D: Sustained virological response (24 weeks after end of treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Intracerebral Hemorrhage Acutely Decreasing Arterial Pressure Trial
Brief Summary: Rationale: Management of blood pressure (BP) in the acute phase of intracerebral hemorrhage (ICH) remains controversial. Although it has been established that there is a transient moderate reduction of perihematoma cerebral blood flow (CBF) in acute ICH, the effect of BP treatment is unknown. The potential for exacerbation of CBF has precluded routine aggressive BP reduction.

Aim and Hypothesis: The primary study aim is to demonstrate the feasibility and safety of acute BP reduction to \< 150 mmHg systolic using a standardized protocol in ICH patients. It is hypothesized that CTP will not demonstrate evidence of perihematoma ischemia following acute BP reduction.

Design: ICH ADAPT is a randomized blinded endpoint trial. Acutely hypertensive ICH patients are randomized to a target systolic BP of \< 150 mmHg or \< 180 mmHg. Patients are treated with intravenous (IV) labetalol/hydralazine/enalapril.

Study Outcomes: The primary outcome is cerebral blood flow in the perihematoma region, measured with CT perfusion, 2 hours after randomization. Secondary outcomes include the difference in BP at 1 and 2 hours post-randomization in the two treatment groups and hematoma expansion rates at 24 hours.

Discussion: ICH ADAPT is the only randomized trial designed specifically to identify any hemodynamic changes in the perihematoma region secondary to aggressive BP management. The results of this trial will facilitate ongoing and future studies aimed at determining the efficacy of rapid BP reduction in acute ICH.


Options:
A: Combination death and dependency, according to a 3-6 scores on the modified Rankin Score. (3 months)
B: Death or major disability (defined by the modified Rankin scale) at 6 months (6 months); The composite event "vascular" death, myocardial infarction, or stroke during the first 6 months (6 months)
C: The primary outcome is cerebral blood flow in the perihematoma region, measured with CT perfusion, 2 hours after randomization. (2 hours post randomization)
D: Number of participants enrolled per month (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of High Intensity Aerobic Interval Training in Cardiac Rehabilitation
Brief Summary: The purpose of the study is to compare home-based aerobic interval training with supervised interval training performed in groups or on a treadmill at the hospital.


Options:
A: Participation in Cardiac Rehabilitation (12 Months)
B: Change in dietary and physical activity behavior (self-report) (Baseline to 8 weeks later)
C: Lifestyle (3 months); Quality of Life (QoL) (3 months); Behavioral flexibility (3 months)
D: VO2peak (baseline, after 12 weeks and after 1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of High Intensity Aerobic Interval Training in Cardiac Rehabilitation
Brief Summary: The purpose of the study is to compare home-based aerobic interval training with supervised interval training performed in groups or on a treadmill at the hospital.


Options:
A: Physical Fitness (Measured after 12 weeks and after one year); Physical Activity Level (PAL) (measured after 12 weeks and after one year)
B: Psychologic aspect (8 weeks); Functional capacity (8 weeks); Disability level (8 weeks); Quality of life (8 weeks)
C: VO2peak (baseline, after 12 weeks and after 1 year)
D: Composite of all-cause mortality and all-cause hospitalization rates (measured at Year 3) (Measured as events occur during the lifespan of the trial.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of High Intensity Aerobic Interval Training in Cardiac Rehabilitation
Brief Summary: The purpose of the study is to compare home-based aerobic interval training with supervised interval training performed in groups or on a treadmill at the hospital.


Options:
A: VO2peak (baseline, after 12 weeks and after 1 year)
B: Reduction of the SCORE Risk Score (6 months after the intervention)
C: Absolute Composite Stress Score (Baseline; 12 weeks); Change From Baseline to 12 Weeks in Individual Scaled Scores (Baseline; 12 weeks)
D: Change in total volume of weekly active energy expenditure (3 and 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of CVD Education and Problem-Solving Training in Urban Diabetics
Brief Summary: The purpose of this study is to determine if patient education and problem-solving training, delivered in self-study, group, and individual intervention modalities, will produce substantial improvements in CVD risk profile via improved self management in urban African Americans with type 2 diabetes and a high CVD risk profile.


Options:
A: Incidence choice for eSET (after embryo transfer)
B: HbA1C (Screening, 3 months post intervention, 6 months post-intervention)
C: Assessment of Pre-implementation, Post-implementation With Decision Coaching, and Post-implementation Without Decision Coaching (30 months)
D: Decision Self Efficacy (post intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Antidepressants in Chronic Back Pain
Brief Summary: This 12 week placebo controlled clinical trial tests the individual and combined effects of an antidepressant medication and cognitive behavioral therapy for chronic back pain.


Options:
A: Change in Weekly Average Pain Intensity (Baseline and Week 21clinic visits)
B: Mechanical and Heat Hyperalgesia (2 week intervals)
C: Composite Syndrome Responder Status (At the end of the three-month stable dose treatment phase); Composite Pain Responder Status (At the end of three-month stable dose treatment phase)
D: Intent-toTreat Analysis of Descriptor Differential Scale (DDS) of Pain Intensity (12 weeks after baseline (or last observation carried forward))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Antidepressants in Chronic Back Pain
Brief Summary: This 12 week placebo controlled clinical trial tests the individual and combined effects of an antidepressant medication and cognitive behavioral therapy for chronic back pain.


Options:
A: Intent-toTreat Analysis of Descriptor Differential Scale (DDS) of Pain Intensity (12 weeks after baseline (or last observation carried forward))
B: Brief Pain Inventory-Intensity (BPI-Intensity) (Post-treatment (10-weeks) and follow-up (6 months))
C: Change in time spent awake during the night. (Change from baseline to the two study follow-ups (immediately and 3-months following treatment)); Change in mood. (Change from baseline to the two follow-up periods (immediately and 3-months following treatment))
D: Quality of life is measured with the FIQ and the EuroQol-5D. (1, 2, 6 and 12 months later)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Nadroparin Anticoagulation for Continuous Venovenous Hemofiltration (CVVH), a Randomized Cross-over Trial Comparing Hemostasis Between Two Hemofiltration Rates
Brief Summary: The low molecular weight heparin nadroparin is used for anticoagulation of the extracorporeal hemofiltration circuit. Continuous hemofiltration is a renal replacement modality for intensive care patients with acute renal failure. Up to now it is not known whether nadroparin is removed by hemofiltration or not. Accumulation would increase the risk of bleeding.

Aim of the present study is to determine

1. whether nadroparin accumulates in plasma
2. whether nadroparin is removed by filtration and whether removal depends on hemofiltration dose
3. the effects of nadroparin during critical illness on coagulation and anticoagulation


Options:
A: To compare the clearance of urea and creatinine by renal replacement therapy (RRT) using continuous venovenous hemofiltration versus continuous venovenous hemodialysis. (48 hours)
B: We will study the feasibility of recruiting ther target population, administering the study therapies according to pre-defined protocols and following patients for clinical endpoints. (60 days)
C: The incidence of premature interruptions of the dialysis procedure attributed to hemofilter clotting. (6 hours after starting dialysis)
D: Accumulation of anti-Xa activity in plasma and removal of anti-Xa activity by filtration. (24 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Nadroparin Anticoagulation for Continuous Venovenous Hemofiltration (CVVH), a Randomized Cross-over Trial Comparing Hemostasis Between Two Hemofiltration Rates
Brief Summary: The low molecular weight heparin nadroparin is used for anticoagulation of the extracorporeal hemofiltration circuit. Continuous hemofiltration is a renal replacement modality for intensive care patients with acute renal failure. Up to now it is not known whether nadroparin is removed by hemofiltration or not. Accumulation would increase the risk of bleeding.

Aim of the present study is to determine

1. whether nadroparin accumulates in plasma
2. whether nadroparin is removed by filtration and whether removal depends on hemofiltration dose
3. the effects of nadroparin during critical illness on coagulation and anticoagulation


Options:
A: Accumulation of anti-Xa activity in plasma and removal of anti-Xa activity by filtration. (24 hours)
B: Renal replacement therapy proportion (28 days)
C: Death (90 days)
D: Death from all causes at 30 days after randomisation (30 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Nadroparin Anticoagulation for Continuous Venovenous Hemofiltration (CVVH), a Randomized Cross-over Trial Comparing Hemostasis Between Two Hemofiltration Rates
Brief Summary: The low molecular weight heparin nadroparin is used for anticoagulation of the extracorporeal hemofiltration circuit. Continuous hemofiltration is a renal replacement modality for intensive care patients with acute renal failure. Up to now it is not known whether nadroparin is removed by hemofiltration or not. Accumulation would increase the risk of bleeding.

Aim of the present study is to determine

1. whether nadroparin accumulates in plasma
2. whether nadroparin is removed by filtration and whether removal depends on hemofiltration dose
3. the effects of nadroparin during critical illness on coagulation and anticoagulation


Options:
A: Functions of inflammatory cells (24 hours); Regulation of inflammatory reactions and and opsonization in microorganisms (24 hours); Activity of acute phase protein during acute inflammation (24 hours)
B: Accumulation of anti-Xa activity in plasma and removal of anti-Xa activity by filtration. (24 hours)
C: 60-day All-cause Mortality (60 days)
D: Mean daily dialysis delivered dose during intensive care stay (dialysis days during intensive care stay)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Nadroparin Anticoagulation for Continuous Venovenous Hemofiltration (CVVH), a Randomized Cross-over Trial Comparing Hemostasis Between Two Hemofiltration Rates
Brief Summary: The low molecular weight heparin nadroparin is used for anticoagulation of the extracorporeal hemofiltration circuit. Continuous hemofiltration is a renal replacement modality for intensive care patients with acute renal failure. Up to now it is not known whether nadroparin is removed by hemofiltration or not. Accumulation would increase the risk of bleeding.

Aim of the present study is to determine

1. whether nadroparin accumulates in plasma
2. whether nadroparin is removed by filtration and whether removal depends on hemofiltration dose
3. the effects of nadroparin during critical illness on coagulation and anticoagulation


Options:
A: Accumulation of anti-Xa activity in plasma and removal of anti-Xa activity by filtration. (24 hours)
B: 60-day All-cause Mortality (60 days)
C: N/A
D: Death from all causes at 90 days after randomisation. (Within 90 days after randomisation)

Answer: A