TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients With Active Ulcerative Colitis
Brief Summary: The purpose of this study is to evaluate the effectiveness and safety of infliximab (Remicade) in patients with Ulcerative Colitis. Infliximab (Remicade) targets specific proteins in the body's immune system to help control the development of inflammation to help reduce painful disease.


Options:
A: Rate of clinical remission (defined by CAI <= 4, with stool frequency and rectal bleeding subscores of ´0´) at week 8 (LOCF) (week 8 (LOCF))
B: Clinical and Endoscopic Remission. (8 weeks)
C: The proportion of patients with clinical response, defined as a decrease from baseline in the Mayo score by = 30% and = 3 points, with a decrease in the rectal bleeding subscore of = 1 or a rectal bleeding subscore of 0 or 1, at week 8 .
D: The proportion of patients with clinical response, defined as a decrease from baseline in the Mayo score by = 30% and = 3 points, with a decrease in the rectal bleeding subscore of = 1 or a rectal bleeding subscore of 0 or 1, at week 8.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients With Active Ulcerative Colitis
Brief Summary: The purpose of this study is to evaluate the effectiveness and safety of infliximab (Remicade) in patients with Ulcerative Colitis. Infliximab (Remicade) targets specific proteins in the body's immune system to help control the development of inflammation to help reduce painful disease.


Options:
A: Remission defined as a decrease in Mayo score to ≤ 2 points at week 4 (week 4)
B: Induction Phase: Percentage of Participants With a Clinical Response at Week 6 (Baseline and Week 6); Maintenance Phase: Percentage of Participants in Clinical Remission at Week 52 (Week 52)
C: The proportion of patients with clinical response, defined as a decrease from baseline in the Mayo score by = 30% and = 3 points, with a decrease in the rectal bleeding subscore of = 1 or a rectal bleeding subscore of 0 or 1, at week 8 .
D: Number of Participants With Clinical Response at Week 6 (Baseline, Week 6)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Placebo-Controlled Study of Ethyl Eicosapentanoic Acid (Ethyl-EPA) in Major Depressive Disorder
Brief Summary: The purpose of this study is to examine the effectiveness of ethyl-eicosapentanoic acid (ethyl-EPA), an omega-3 fatty acid, in treating depression.


Options:
A: Alleviation of depressive symptoms
B: ACC Glx/Water (baseline and 10-weeks); ACC GABA/Water (baseline and 10-weeks)
C: Beck Depression Inventory-II (Measured at Baseline and 10 weeks)
D: Percentage of Participants with major depressive episode (for Study 1); Changes in Hamilton Depression Rating Scale (HDRS) (for Study 2) (Weeks 0 to 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Delirium in the ICU: a Prospective, Randomized, Trial of Placebo vs. Haloperidol vs. Ziprasidone
Brief Summary: Delirium is associated with increased risk of death, prolonged stay, higher cost of care, and likely long-term brain deficits in survivors. This form of brain dysfunction occurs in intensive care unit (ICU) patients in epidemic proportions, and the scope of this problem is likely to worsen in upcoming years due to the aging of our population and increased utilization of the ICU. Currently, delirium goes unrecognized and untreated in the vast majority of circumstances in the ICU unless the patient presents with hyperactive delirium and agitation. In the latter circumstance, a commonly used typical antipsychotic called haloperidol is considered the principal agent for treating delirium based largely on anecdotal evidence to support its usefulness, though no placebo controlled trials exist. There are no FDA approved medications for delirium. The atypical antipsychotics provide a promising alternative for the treatment of delirium due to their enhanced beneficial effects on positive (agitated) and negative (quiet) symptoms proven in mania and schizophrenia, reduced risk for side effects common to haloperidol such as extrapyramidal symptomatology, and less potentially lethal heart rhythm disturbances. It is imperative that well-designed phase II studies to determine proof of principle be conducted. A pilot study of feasibility to begin assessing the role of antipsychotics in the management of ICU delirium.


Options:
A: Duration of delirium (3 months)
B: Days alive and free of delirium and coma (delirium and coma free days) (enrollment to day 21)
C: Reduction of ICU delirium duration assessed by ICDSC checklist (during stay at ICU, an average of 3 days; Delirium duration assessed every 8 hours starting with patient's ICU admission until delirium has subsided)
D: The percentage of time spent within the protocol specified sedation range (Richmond Agitation-Sedation Scale [RASS] range of -2 to +1) (Preinfusion, Treatment period: every 10min for 30min, 1 & 4 hr after infusion starts, every 4 hrs, prior to end of infusion & extubation. Follow-up Period (48hrs): every 10min for 1st 30min after drug discontinuation, 1, 4, 8,12, 24 & 48 hr post infusion)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Delirium in the ICU: a Prospective, Randomized, Trial of Placebo vs. Haloperidol vs. Ziprasidone
Brief Summary: Delirium is associated with increased risk of death, prolonged stay, higher cost of care, and likely long-term brain deficits in survivors. This form of brain dysfunction occurs in intensive care unit (ICU) patients in epidemic proportions, and the scope of this problem is likely to worsen in upcoming years due to the aging of our population and increased utilization of the ICU. Currently, delirium goes unrecognized and untreated in the vast majority of circumstances in the ICU unless the patient presents with hyperactive delirium and agitation. In the latter circumstance, a commonly used typical antipsychotic called haloperidol is considered the principal agent for treating delirium based largely on anecdotal evidence to support its usefulness, though no placebo controlled trials exist. There are no FDA approved medications for delirium. The atypical antipsychotics provide a promising alternative for the treatment of delirium due to their enhanced beneficial effects on positive (agitated) and negative (quiet) symptoms proven in mania and schizophrenia, reduced risk for side effects common to haloperidol such as extrapyramidal symptomatology, and less potentially lethal heart rhythm disturbances. It is imperative that well-designed phase II studies to determine proof of principle be conducted. A pilot study of feasibility to begin assessing the role of antipsychotics in the management of ICU delirium.


Options:
A: decrease in delirium rating scale and clinical global improvement (7 days)
B: Days alive and free of delirium and coma (delirium and coma free days) (enrollment to day 21)
C: Time from the commencement of treatment to extubation (days)
D: Ventilator-free hours (7 days following randomisation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Differences in Cognitive Function Due to Acute Sedative Effects of Risperidone and Quetiapine in Stable Bipolar I Out-Patients.
Brief Summary: The purpose of this study is to determine whether the sedating (causing sleepiness) effects of risperidone or quetiapine alter cognitive (person's ability to think, perceive, recognize, remember, judge, and reason) functioning in subjects with stable Bipolar I Disorder.


Options:
A: Reduction of PANSS total score (Admission, discharge/ 6 weeks if not discharged, 3, 6, 12, 24 months after admittance.)
B: To compare the treatment effects of risperidone and quetiapine on cognitive function due to sedation
C: Acute efficacy: Change in Young Mania Rating Scale (YMRS) total score from baseline to endpoint of 3 weeks of acute treatment period.
D: Mood symptom improvement. (Baseline to exit); Cocaine or methamphetamine cravings and use. (Baseline to exit)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Estrogen Use in Protection From Cognitive Decline
Brief Summary: This study is designed to assess the effects of estrogen therapy among postmenopausal women at risk for cognitive decline.


Options:
A: N/A
B: Changes in cognition and brain metabolism (Baseline and 24 months)
C: Rate of change of carotid intimal medial thickness by ultrasound (Measured at screening, 12, 24, 36, and 48 months)
D: Global disease activity throughout the follow-up period, estimated as the area under the SLEDAI-curve

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Efficacy of Insulin Aspart Versus Insulin Lispro in Insulin Pumps in Children and Adolescents With Type 1 Diabetes
Brief Summary: This trial is conducted in the United States of America (USA). It is demonstrated that intensive insulin therapy resulting in good glycaemic control can reduce or delay the incidence of complications secondary to Type 1 Diabetes. Insulin Aspart (NovoLog®) is an ideal insulin to use in an intensive insulin regimen using continuous subcutaneous insulin injection (CSII) therapy in the pediatric and adolescent age population. This trial compares the safety and efficacy of Insulin Aspart (NovoLog®) and Insulin Lispro (Humalog®) delivered by CSII in children and adolescents with type 1 diabetes.


Options:
A: Relative risk of major maternal hypoglycaemia (after 24 hours)
B: Hemoglobin A1C (HbA1C) (After 16 weeks of treatment)
C: HbA1c (After 16 weeks treatment)
D: Mean Blood Glucose Concentration (hospital stay days 2-10)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: RCT of Antioxidant Therapy to Prevent Preeclampsia in Brazil
Brief Summary: The perinatal morbidity and mortality rates for Brazil are five to ten-fold higher than those reported for upper income countries. This study tests the likelihood that the joint administration of antioxidants vitamin C (1000 mg) and vitamin E (400 IU) will reduce the incidence of preeclampsia among chronically hypertensive pregnant patients and patients with a past history of preeclampsia/eclampsia.


Options:
A: Birth weight; 3-month infant mortality
B: Recurrence of cleft lip and palate (3 months)
C: Weight, length and Rohrer index at birth, and gestational duration in single pregnancies. (At birth); Mortality, morbidity and growth during the first year of life (Monthly during infancy)
D: Incidence of preeclampsia

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: RCT of Misoprostol for Postpartum Hemorrhage in India
Brief Summary: Death rates for pregnant women in rural India are approximately forty-five times higher than in the United States. Bleeding after the birth of a child and underlying anemia are the primary causes of mothers' deaths and sickness in rural India. This study assesses the effectiveness of an oral drug, misoprostol, given in the late stage of labor to reduce the incidence of maternal bleeding following births assisted by midwives in selected sites in Belgaum District, Karnataka, India.


Options:
A: Need for additional treatment after initial PPH study treatment (all additional interventions recorded following initial uterotonic treatment)
B: Incidence of acute postpartum hemorrhage: blood loss ≥ 500 ml within two hours of delivery
C: Blood loss =>500 mls within one hour after enrollment
D: Blood loss greater than or equal to 500 mls after enrolment (Blood loss measured for minimum of 1 hour or until active bleeding ceased)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: RCT of Misoprostol for Postpartum Hemorrhage in India
Brief Summary: Death rates for pregnant women in rural India are approximately forty-five times higher than in the United States. Bleeding after the birth of a child and underlying anemia are the primary causes of mothers' deaths and sickness in rural India. This study assesses the effectiveness of an oral drug, misoprostol, given in the late stage of labor to reduce the incidence of maternal bleeding following births assisted by midwives in selected sites in Belgaum District, Karnataka, India.


Options:
A: Mean change in hemoglobin (during 3rd trimester and 1-3 days postpartum)
B: the amount of blood loss in third and fourth stages of labor (The end of the delivery to 2 hours after birth.)
C: The change in hemoglobin as a measure of blood loss. The change in hemoglobin is defined as the difference between the predelivery hemoglobin value and the postpartum value (1 year)
D: Incidence of acute postpartum hemorrhage: blood loss ≥ 500 ml within two hours of delivery

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: RCT of Misoprostol for Postpartum Hemorrhage in India
Brief Summary: Death rates for pregnant women in rural India are approximately forty-five times higher than in the United States. Bleeding after the birth of a child and underlying anemia are the primary causes of mothers' deaths and sickness in rural India. This study assesses the effectiveness of an oral drug, misoprostol, given in the late stage of labor to reduce the incidence of maternal bleeding following births assisted by midwives in selected sites in Belgaum District, Karnataka, India.


Options:
A: Uterine tone. (2 minutes)
B: The amount of blood loss in the third and fourth stages (the fourth stage of labor begins with delivery of the placenta and ends 2 hours after delivery) of labor. (2 hours)
C: Incidence of acute postpartum hemorrhage: blood loss ≥ 500 ml within two hours of delivery
D: Maximal uterine tone (within the first 5 minutes after cord clamping)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab (Mabthera/Rituxan) in Adults With Relapsing Remitting Multiple Sclerosis
Brief Summary: This is a Phase II, randomized, double-blind, parallel group, placebo controlled, multicenter study to evaluate the safety and efficacy of Rituximab in adults with RRMS.


Options:
A: To investigate the efficacy of rituximab compared with placebo, as measured by MRI scans of the brain for the total number of lesions observed, and to evaluate the safety and tolerability of rituximab in subjects with RRMS.
B: Analysis of Changes in CSF CXCL13 Induced by Active Treatment (Rituximab) Measured 3 Months After 1st Drug Administration (3 months); Analysis of Changes in CSF BAFF Induced by Active Treatment (Rituximab) Measured 3 Months After 1st Drug Administration (3 months)
C: Percentage of Participants Aware of Known and Potential Risks of Infection Associated with Rituximab (Up to 10 months); Percentage of Participants Using Rituximab Off-Label (Up to 10 months)
D: Time to Confirmed Disease Progression (CDP) (96 weeks (from Screening to Week 96, and at least 12 weeks after initial progression)); Percentage of Participants With CDP (96 weeks (from Screening to Week 96, and at least 12 weeks after initial progression))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab (Mabthera/Rituxan) in Adults With Relapsing Remitting Multiple Sclerosis
Brief Summary: This is a Phase II, randomized, double-blind, parallel group, placebo controlled, multicenter study to evaluate the safety and efficacy of Rituximab in adults with RRMS.


Options:
A: remission without corticosteroids and without surgical resection (month 6 and 12 after inclusion)
B: Visual analogue scale pain score, Oswestry disability index, medication intake (7 months)
C: Percentage of Participants With an American College of Rheumatology 20 (ACR20) Response (Baseline to the end of the retreatment period (up to 7 years, 6 months))
D: To investigate the efficacy of rituximab compared with placebo, as measured by MRI scans of the brain for the total number of lesions observed, and to evaluate the safety and tolerability of rituximab in subjects with RRMS.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab (Mabthera/Rituxan) in Adults With Relapsing Remitting Multiple Sclerosis
Brief Summary: This is a Phase II, randomized, double-blind, parallel group, placebo controlled, multicenter study to evaluate the safety and efficacy of Rituximab in adults with RRMS.


Options:
A: Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core) (Month 6 (Core)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 12 (Month 12 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 60 (Month 60 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at End of Study (Last observation (Up to 80 months in average))
B: Time to Conversion to Multiple Sclerosis (MS) According to the McDonald Criteria (2005) (Various time points from randomization up to 24 months); Time to Conversion to Multiple Sclerosis (MS) According to the McDonald Criteria (2005) (Various time points from randomization up to 36 months)
C: Confirmed Annualized Relapse Rate (up to 12 months)
D: To investigate the efficacy of rituximab compared with placebo, as measured by MRI scans of the brain for the total number of lesions observed, and to evaluate the safety and tolerability of rituximab in subjects with RRMS.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Aripiprazole Monotherapy in the Treatment of Acutely Manic Patients With Bipolar I Disorder
Brief Summary: The purpose of this research study is to confirm the safety and effectiveness of aripiprazole therapy over 12 weeks in subjects with bipolar disorder experiencing symptoms of mania.


Options:
A: Change from baseline to endpoint in a mania rating scale
B: Scores in the Young Mania Rating Scale (BD); Scores in the SNAP-IV (ADHD); Weight
C: Scores in the SNAP-IV (ADHD); Scores in the Young Mania Rating Scale (BD); Weight
D: Change in a mania rating scale at endpoint

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Comparison of CS-747 and Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention
Brief Summary: The sponsors of this investigational drug are developing prasugrel (also known as CS-747) as a possible treatment for patients with acute coronary syndrome (heart attack or chest pain) who need, or are expected to need, a percutaneous coronary intervention (PCI; also called a balloon angioplasty). Prasugrel was compared with Clopidogrel to determine which drug is better at reducing deaths, future heart attacks, or stroke.


Options:
A: MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT (18 months (12-30 months post-index procedure)); Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT (18 months (12-30 months post-index procedure)); GUSTO Severe or Moderate Bleeding - Randomized DES ITT (18 months (12-30 months post-index procedure))
B: Composite of death, myocardial infarction, definite stent thrombosis, stroke or major bleeding. (9 months)
C: Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke (Randomization up to 15 months)
D: Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Superiority for Composite of Stroke and Systemic Embolic Events (SEE). (overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Comparison of CS-747 and Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention
Brief Summary: The sponsors of this investigational drug are developing prasugrel (also known as CS-747) as a possible treatment for patients with acute coronary syndrome (heart attack or chest pain) who need, or are expected to need, a percutaneous coronary intervention (PCI; also called a balloon angioplasty). Prasugrel was compared with Clopidogrel to determine which drug is better at reducing deaths, future heart attacks, or stroke.


Options:
A: Composite of All-cause Mortality and Nonfatal MI (30 days); All-cause Mortality and Nonfatal MI (1 year)
B: Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke (Randomization up to 15 months)
C: Percentage of Participants With a Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke (Randomization through end of study (30-month visit))
D: Changes in renal function in diabetic patients treated with aspirin (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Comparison of CS-747 and Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention
Brief Summary: The sponsors of this investigational drug are developing prasugrel (also known as CS-747) as a possible treatment for patients with acute coronary syndrome (heart attack or chest pain) who need, or are expected to need, a percutaneous coronary intervention (PCI; also called a balloon angioplasty). Prasugrel was compared with Clopidogrel to determine which drug is better at reducing deaths, future heart attacks, or stroke.


Options:
A: Occurrence of myocardial infarction,stroke or cardiovascular death.
B: The composite of cardiac death or MI in the intent-to-treat population (1 year after randomization)
C: Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke (Randomization up to 15 months)
D: Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR) (randomization through 48 hours after randomization)

Answer: C