TrialPanorama/Dataset huggingface dataset:
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: Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke (Randomization up to 12 months); Participants With Any Major Bleeding Event (First dosing up to 12 months)
B: Release of troponin evaluated by the peak of troponin during the hospital phase (during the hospital phase)
C: The composite of all-cause mortality, myocardial (re)infarction, disabling stroke and re-hospitalization for cardiovascular causes or severe bleeding within 1 yr. (1 year)
D: Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke (Randomization up to 15 months)

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: The composite of cardiovascular death, myocardial infarction (MI) and stroke
B: Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment (6- or 12-month study treatment period)
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: The primary efficacy endpoint was the composite of symptomatic recurrent DVT or symptomatic fatal and non-fatal PE at 12 weeks and deterioration in thrombotic burden, as assessed by CUS and PLS, at baseline and at 12 weeks. (12 weeks)

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: Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only) (time since randomization; follow-up period is 1.5 to 4.4 years); Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Telmisartan vs. Placebo Only) (time since randomization; follow-up period is 1.5 to 4.4 years)
B: acomposite of mortality, nonfatal myocardial infarction and nonfatal stroke (30 months intake; 12-42 months follow-up)
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: Occurrence of myocardial infarction,stroke or cardiovascular death.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitive Impairment in the ICU: Evaluation and Outcomes
Brief Summary: The purpose of this study is to determine the impact of a new RN/RRT (Registered Nurse/Registered Respiratory Therapist) directed 2-step protocol to wean patients off of a ventilator. This protocol involves daily attempts to halt sedation (spontaneous awakening trials) combined with daily assessments of patients while they are breathing on their own (spontaneous breathing trials).


Options:
A: Duration of Ventilation
B: Duration of Mechanical Ventilation; ICU and Hospital Lengths of stay
C: time to successful extubation (This will be the length of time that the patient remains on continuous infusions of sedation and/or analgesia in the ICU. At 60 days, all study interventions will terminate, but patients will be followed for outcomes.)
D: Ventilator free days

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitive Impairment in the ICU: Evaluation and Outcomes
Brief Summary: The purpose of this study is to determine the impact of a new RN/RRT (Registered Nurse/Registered Respiratory Therapist) directed 2-step protocol to wean patients off of a ventilator. This protocol involves daily attempts to halt sedation (spontaneous awakening trials) combined with daily assessments of patients while they are breathing on their own (spontaneous breathing trials).


Options:
A: Time receiving mechanical ventilation, total intensive care and hospital length of stay.
B: Ventilator free days
C: Proportion of time during sedative infusion with a Richmond Agitation Sedation Scale (RASS) score within the individually-prescribed target range; Time from ICU admission to discharge
D: achieving target sedation level (Patients will receive study drug for a maximum of 120 hours (5 days))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitive Impairment in the ICU: Evaluation and Outcomes
Brief Summary: The purpose of this study is to determine the impact of a new RN/RRT (Registered Nurse/Registered Respiratory Therapist) directed 2-step protocol to wean patients off of a ventilator. This protocol involves daily attempts to halt sedation (spontaneous awakening trials) combined with daily assessments of patients while they are breathing on their own (spontaneous breathing trials).


Options:
A: Time From Study Drug Initiation to Tracheal Extubation (Duration of ICU stay, for up to 24 weeks)
B: 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)
C: Ventilator free days
D: Proportion of time during sedative infusion with a Richmond Agitation Sedation Scale (RASS) score within the individually-prescribed target range; Time from ICU admission to discharge

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: MOTOR: Maternal Oral Therapy to Reduce Obstetric Risk
Brief Summary: The purpose of this study is to determine whether maternal periodontal therapy (tooth cleaning) decreases the rate of preterm deliveries at \<37 weeks gestation and to determine the effects of maternal periodontal therapy on the birth weight of infants born less than 37 weeks gestation.


Options:
A: Birth at less than 37 weeks gestational age (37 weeks gestational age)
B: Whether screening and treating periodontal disease using scaling and root planing early in pregnancy can reduce the incidence of spontaneous preterm birth <35 weeks (9 months)
C: Gestational age at birth (At delivery)
D: Rate of pre-term birth

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: VITATOPS - A Study of VITAmins TO Prevent Stroke
Brief Summary: The VITATOPS study is a multi-center, randomized, double blind, placebo-controlled secondary stroke prevention trial to determine whether the addition of vitamin supplements (B12 500 ug, B6 25 mg, Folate 2 mg) to best medical/surgical management (including modification of risk factors) will reduce the combined incidence of recurrent vascular events (stroke, myocardial infarction) and vascular death in patients with recent stroke or transient ischemic attack (TIA). All patients presenting to one of the participating neurologists or general physicians within seven months of stroke (ischemic or hemorrhagic) or TIA (eye or brain) are eligible for this trial. Eligible patients will be randomized in a double-blind fashion to receive multi-vitamins or placebo, 1 tablet daily. The primary outcome event is the composite event "stroke, myocardial infarction, or death from any vascular cause", whichever occurs first. Our target is to recruit a total of 8,000 patients over the next two years with a median follow-up of 2.5 years. Recruitment to the trial began in November 1998 and is planned to continue until December 2005. We aim to complete final follow-up by the end of 2006. However, the Steering Committee will be flexible in dictating the need for ongoing recruitment and continuing follow-up, depending on the overall rate of the primary outcome event in the entire cohort at each interim analysis.


Options:
A: Major Depression Inventory (MDI) (Depression at one point in the study (not including baseline) out of 6 measurements at app. day 14.); Major Depression Inventory (MDI) (Depression at one point in the study (not including baseline) out of 6 measurements at app. day 28); Major Depression Inventory (MDI) (Depression at one point in the study (not including baseline) out of 6 measurements at app. day 42); Major Depression Inventory (MDI) (Depression at one point in the study (not including baseline) out of 6 measurements at app. day 56); Major Depression Inventory (MDI) (Depression at one point in the study (not including baseline) out of 6 measurements at app. day 70); Major Depression Inventory (MDI) (Depression at one point in the study (not including baseline) out of 6 measurements at app. day 84)
B: Depression (4 months)
C: Non-fatal Stroke, Non-fatal Myocardial Infarction or Death Due to Vascular Causes (The primary outcome was measured over a median follow-up period of 3.4 years (interquartile range IQR 1.0-5.5 years).)
D: Hamilton Depression Scale; International Classification of Diseases, Revision 10 (ICD-10) Mood Disorder Diagnosis

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: VITATOPS - A Study of VITAmins TO Prevent Stroke
Brief Summary: The VITATOPS study is a multi-center, randomized, double blind, placebo-controlled secondary stroke prevention trial to determine whether the addition of vitamin supplements (B12 500 ug, B6 25 mg, Folate 2 mg) to best medical/surgical management (including modification of risk factors) will reduce the combined incidence of recurrent vascular events (stroke, myocardial infarction) and vascular death in patients with recent stroke or transient ischemic attack (TIA). All patients presenting to one of the participating neurologists or general physicians within seven months of stroke (ischemic or hemorrhagic) or TIA (eye or brain) are eligible for this trial. Eligible patients will be randomized in a double-blind fashion to receive multi-vitamins or placebo, 1 tablet daily. The primary outcome event is the composite event "stroke, myocardial infarction, or death from any vascular cause", whichever occurs first. Our target is to recruit a total of 8,000 patients over the next two years with a median follow-up of 2.5 years. Recruitment to the trial began in November 1998 and is planned to continue until December 2005. We aim to complete final follow-up by the end of 2006. However, the Steering Committee will be flexible in dictating the need for ongoing recruitment and continuing follow-up, depending on the overall rate of the primary outcome event in the entire cohort at each interim analysis.


Options:
A: Non-fatal Stroke, Non-fatal Myocardial Infarction or Death Due to Vascular Causes (The primary outcome was measured over a median follow-up period of 3.4 years (interquartile range IQR 1.0-5.5 years).)
B: Recurrent stroke (3 years); Myocardial infarction (3 years); Death due to other vascular causes (3 years)
C: Major fatal and non fatal ischemic cardiovascular events; Cancer any kind except for basal cell skin carcinoma
D: Change in Clinical Dementia Rating Scale (CDR) (Change from baseline in CDR at month 9, 18, 27)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: VITATOPS - A Study of VITAmins TO Prevent Stroke
Brief Summary: The VITATOPS study is a multi-center, randomized, double blind, placebo-controlled secondary stroke prevention trial to determine whether the addition of vitamin supplements (B12 500 ug, B6 25 mg, Folate 2 mg) to best medical/surgical management (including modification of risk factors) will reduce the combined incidence of recurrent vascular events (stroke, myocardial infarction) and vascular death in patients with recent stroke or transient ischemic attack (TIA). All patients presenting to one of the participating neurologists or general physicians within seven months of stroke (ischemic or hemorrhagic) or TIA (eye or brain) are eligible for this trial. Eligible patients will be randomized in a double-blind fashion to receive multi-vitamins or placebo, 1 tablet daily. The primary outcome event is the composite event "stroke, myocardial infarction, or death from any vascular cause", whichever occurs first. Our target is to recruit a total of 8,000 patients over the next two years with a median follow-up of 2.5 years. Recruitment to the trial began in November 1998 and is planned to continue until December 2005. We aim to complete final follow-up by the end of 2006. However, the Steering Committee will be flexible in dictating the need for ongoing recruitment and continuing follow-up, depending on the overall rate of the primary outcome event in the entire cohort at each interim analysis.


Options:
A: Cardiovascular disease; Cancer
B: Non-fatal Stroke, Non-fatal Myocardial Infarction or Death Due to Vascular Causes (The primary outcome was measured over a median follow-up period of 3.4 years (interquartile range IQR 1.0-5.5 years).)
C: Major fatal and non fatal ischemic cardiovascular events; Cancer any kind except for basal cell skin carcinoma
D: Depression (Baseline, 6 weeks, 6-, 12-, 48-, and 51 month followups.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: VITATOPS - A Study of VITAmins TO Prevent Stroke
Brief Summary: The VITATOPS study is a multi-center, randomized, double blind, placebo-controlled secondary stroke prevention trial to determine whether the addition of vitamin supplements (B12 500 ug, B6 25 mg, Folate 2 mg) to best medical/surgical management (including modification of risk factors) will reduce the combined incidence of recurrent vascular events (stroke, myocardial infarction) and vascular death in patients with recent stroke or transient ischemic attack (TIA). All patients presenting to one of the participating neurologists or general physicians within seven months of stroke (ischemic or hemorrhagic) or TIA (eye or brain) are eligible for this trial. Eligible patients will be randomized in a double-blind fashion to receive multi-vitamins or placebo, 1 tablet daily. The primary outcome event is the composite event "stroke, myocardial infarction, or death from any vascular cause", whichever occurs first. Our target is to recruit a total of 8,000 patients over the next two years with a median follow-up of 2.5 years. Recruitment to the trial began in November 1998 and is planned to continue until December 2005. We aim to complete final follow-up by the end of 2006. However, the Steering Committee will be flexible in dictating the need for ongoing recruitment and continuing follow-up, depending on the overall rate of the primary outcome event in the entire cohort at each interim analysis.


Options:
A: The composite of cardiovascular death, myocardial infarction (MI) and stroke
B: N/A
C: Non-fatal Stroke, Non-fatal Myocardial Infarction or Death Due to Vascular Causes (The primary outcome was measured over a median follow-up period of 3.4 years (interquartile range IQR 1.0-5.5 years).)
D: Common carotid artery intima media thickness; Brachial artery flow mediated vasodilatation

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness and Safety of Intermittent Antimicrobial Therapy for the Treatment of New Onset Pseudomonas Aeruginosa Airway Infection in Young Patients With Cystic Fibrosis
Brief Summary: Cystic fibrosis (CF) is a chronic disease that significantly affects an individual's lung function. Antibiotic medications have been proven effective at reducing Pseudomonas aeruginosa (PA) infection, which is one of the main causes of death in individuals with CF. The purpose of this study is to compare the effectiveness of treatment based on quarterly culture results versus consistent quarterly antibiotic treatment at reducing PA infection in children with CF.


Options:
A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (From start of study until end of the study (up to 168 days)); Relative Change From Baseline in Percent Predicted Forced Expiratory Volume in One Second (FEV1) (Baseline, day 28)
B: Feasibility of using the CFF National Patient Registry (28 days from time of start of IV antibiotic therapy.)
C: Number of Participants With a Pulmonary Exacerbation Requiring IV Antibiotics or Hospitalization (Measured over the 18 month study)
D: To better define risk factors for first isolation of Pa from respiratory culture, as well as for emergence of mucoid Pa and antibiotic-resistant Pa. (over the two-to-five-year observational period); To better define clinical outcomes associated with acquisition of Pa, as well as outcomes associated with emergence of mucoid Pa and antibiotic-resistant Pa. (over the two-to-five-year observational period)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness and Safety of Intermittent Antimicrobial Therapy for the Treatment of New Onset Pseudomonas Aeruginosa Airway Infection in Young Patients With Cystic Fibrosis
Brief Summary: Cystic fibrosis (CF) is a chronic disease that significantly affects an individual's lung function. Antibiotic medications have been proven effective at reducing Pseudomonas aeruginosa (PA) infection, which is one of the main causes of death in individuals with CF. The purpose of this study is to compare the effectiveness of treatment based on quarterly culture results versus consistent quarterly antibiotic treatment at reducing PA infection in children with CF.


Options:
A: Change in P. Aeruginosa Density (from baseline to end of treatment (28 days))
B: Clinically Significant Laboratory Abnormalities. (28 Days)
C: Time to a Protocol-defined Pulmonary Exacerbation (Over the 18-month study period)
D: Number of Participants With a Pulmonary Exacerbation Requiring IV Antibiotics or Hospitalization (Measured over the 18 month study)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness and Safety of Intermittent Antimicrobial Therapy for the Treatment of New Onset Pseudomonas Aeruginosa Airway Infection in Young Patients With Cystic Fibrosis
Brief Summary: Cystic fibrosis (CF) is a chronic disease that significantly affects an individual's lung function. Antibiotic medications have been proven effective at reducing Pseudomonas aeruginosa (PA) infection, which is one of the main causes of death in individuals with CF. The purpose of this study is to compare the effectiveness of treatment based on quarterly culture results versus consistent quarterly antibiotic treatment at reducing PA infection in children with CF.


Options:
A: Change in P. Aeruginosa Density (from baseline to end of treatment (28 days))
B: Time to Recurrence of Pseudomonas (P.) Aeruginosa (Any Genotype) in Sputum or Deep Throat Cough Swab (From 1 month after the end of treatment (Day 56 for the 28-day treatment group and Month 3 for the 56-day treatment group) until the end of the study (Month 27))
C: To better define risk factors for first isolation of Pa from respiratory culture, as well as for emergence of mucoid Pa and antibiotic-resistant Pa. (over the two-to-five-year observational period); To better define clinical outcomes associated with acquisition of Pa, as well as outcomes associated with emergence of mucoid Pa and antibiotic-resistant Pa. (over the two-to-five-year observational period)
D: Number of Participants With a Pulmonary Exacerbation Requiring IV Antibiotics or Hospitalization (Measured over the 18 month study)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness and Safety of Intermittent Antimicrobial Therapy for the Treatment of New Onset Pseudomonas Aeruginosa Airway Infection in Young Patients With Cystic Fibrosis
Brief Summary: Cystic fibrosis (CF) is a chronic disease that significantly affects an individual's lung function. Antibiotic medications have been proven effective at reducing Pseudomonas aeruginosa (PA) infection, which is one of the main causes of death in individuals with CF. The purpose of this study is to compare the effectiveness of treatment based on quarterly culture results versus consistent quarterly antibiotic treatment at reducing PA infection in children with CF.


Options:
A: To better define risk factors for first isolation of Pa from respiratory culture, as well as for emergence of mucoid Pa and antibiotic-resistant Pa. (over the two-to-five-year observational period); To better define clinical outcomes associated with acquisition of Pa, as well as outcomes associated with emergence of mucoid Pa and antibiotic-resistant Pa. (over the two-to-five-year observational period)
B: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
C: Number of Participants With a Pulmonary Exacerbation Requiring IV Antibiotics or Hospitalization (Measured over the 18 month study)
D: Time to a Protocol-defined Pulmonary Exacerbation (Over the 18-month study period)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness and Safety of Intermittent Antimicrobial Therapy for the Treatment of New Onset Pseudomonas Aeruginosa Airway Infection in Young Patients With Cystic Fibrosis
Brief Summary: Cystic fibrosis (CF) is a chronic disease that significantly affects an individual's lung function. Antibiotic medications have been proven effective at reducing Pseudomonas aeruginosa (PA) infection, which is one of the main causes of death in individuals with CF. The purpose of this study is to compare the effectiveness of treatment based on quarterly culture results versus consistent quarterly antibiotic treatment at reducing PA infection in children with CF.


Options:
A: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
B: Number of Participants With a Pulmonary Exacerbation Requiring IV Antibiotics or Hospitalization (Measured over the 18 month study)
C: Change From Baseline to End of the Treatment Period of Forced Expiratory Volume in 1 Second (FEV1), Expressed as Percentage of Predicted Normal (Day 0 (baseline), Week 4)
D: Rate of Protocol-defined Exacerbations (PDE) From Baseline Through Week 24 (Baseline in the comparative phase to the end of study (average time on study during the Comparative Phase: 155.4 days))

Answer: B