TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing the Pro-ischaemic Effects of Ambient Particulate Air Pollution in Patients With Coronary Heart Disease Using a Simple Face Mask Intervention
Brief Summary: Air pollution is a major cause of cardiorespiratory morbidity and mortality. The exact components of air pollution that underlie the cardiovascular effects are not yet known, but combustion-derived particulate matter is suspected to be the major cause. Epidemiological studies have shown that exposure to air pollution causes exacerbation of existing cardiorespiratory conditions leading to increased hospital admissions and death. The investigators have recently conducted a series of controlled exposure studies to urban particulate matter and diesel exhaust in healthy volunteers and patients with coronary heart disease. The investigators found that controlled exposure to dilute diesel exhaust in patients with prior myocardial infarction induced asymptomatic myocardial ischaemia with an increase in electrocardiographic measures of myocardial ischaemia. Whilst important, further questions remain: (i) does air pollution exposure exacerbate ischaemia and reduce exercise tolerance in patients with symptomatic angina pectoris, (ii) do "real world" exposures as encountered in the urban environment of major cities have similar effects, and (iii) can a simple face mask intervention to reduce exposure to particulate air pollution improve health outcomes in patients with coronary heart disease?


Options:
A: the frequency of exacerbation of COPD per year (3 year)
B: Comparison of Asthma Control Test (ACT) questionnaire score between the no intervention group and the intervention groups in asthmatic children during the high DDS period of 2019 (4 months); Comparison of Asthma Control Test (ACT) questionnaire score between the no intervention group and the intervention groups in asthmatic children during the high DDS period of 2020 (4 months); Comparison of the number and duration of high atrial frequency episode between the no intervention group and the intervention groups in adults with AF during the high DDS period of 2019. (6 months); Comparison of the number and duration of high atrial frequency episode between the no intervention group and the intervention groups in adults with AF during the high DDS period of 2020. (6 months)
C: Myocardial ischaemic burden determined using continuous electrographic monitoring (During 2 hour walk and subsequent 24 hour period)
D: Asthma control using the asthma control diary (After 1 month); Severe asthma exacerbations (1 year & preliminary analysis after 1 month); Moderate asthma exacerbations (1 year & preliminary analysis after 1 month)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Randomised Study of Automated Versus Mercury Blood Pressure Recordings in Pregnancy
Brief Summary: The aim of the PRAM study was to determine whether women diagnosed with hypertension in pregnancy, using the traditional mercury device, have the same pregnancy outcomes when blood pressure is measured by either an automated device or a mercury device throughout the pregnancy.


Options:
A: Time from recruitment to diagnosis of raised blood pressure (From study entry to delivery i.e. up to approximately 25 weeks from recruitment); Mean systolic blood pressure (From study entry to delivery i.e. up to 40 weeks)
B: Gestational age (GA) (Throug study completion, from the first contact with the gynaecologist (after fertilization) untill 34 weeks of gestation.); hospitalization (From 32 weeks of gestation until 34 weeks of gestation); Changes in CV physiological parameters - electrocardiogram (ECT) with Doppler ultrasonography (Month 3 to month 9); changes in CV physiological parameters - impedance cardiography (Month 3 to month 9); changes in CV physiological parameters - bio impedance (Month 3 to month 9); Arterial parameters - pulse transit time (Month 3 to month 9); Arterial parameters - pulsatility index (Month 3 to month 9); Arterial parameters - resistivity index of the left and right arcuate arteries (Month 3 to month 9); venous parameters - venous pulse transit time of the hepatic and left and right renal veins (Month 3 to month 9); venous parameters - hepatic vein impedance index (Month 3 to month 9); venous parameters - left and right renal interlobar vein impedance indices (Month 3 to month 9); systolic blood pressure (Month 3 to month 9); diastolic blood pressure (Month 3 to month 9); Mean arterial blood pressure (Month 3 to month 9); Total body water (Month 3 to month 9); extracellular water (Month 3 to month 9); intracellular water (Month 3 to month 9); ECW/ICW ratio (Month 3 to month 9); stroke volume (Month 3 to month 9); hear rate (beats/min) (Month 3 to month 9); cardiac output (l/min) (Month 3 to month 9); velocity index (1/1,000/s) (Month 3 to month 9); acceleration index (1/100/s²) (Month 3 to month 9); total peripheral resistance (dyn·s·cm-5) (Month 3 to month 9)
C: The primary maternal outcome measure was the number of women having any episode of severe hypertension (BP ³ 170/110mmHg).
D: Niccomo measurement (10 weeks of pregnancy); Niccomo measurement (20 weeks of pregnancy); Systolic and Diastolic Blood pressure monitoring (10 weeks of pregnancy); Systolic and Diastolic Blood pressure monitoring (20 weeks of pregnancy); a maternal Venous Doppler Echochraphy (10 weeks of pregnancy); Maltron measurement (10 weeks of pregnancy); a maternal Venous Doppler Echochraphy (20 weeks of pregnancy); Maltron measurement (20 weeks of pregnancy); Activity tracker (10 weeks of pregnancy); Weight (10 weeks of pregnancy); Activity tracker (20 weeks of pregnancy); Weight (20 weeks of pregnancy)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D AND Cardiovascular Disease
Brief Summary: In this study the investigators want to compare glucose handling (insulin secretion and insulin sensitivity) in 100 persons with low and 50 persons with normal-high levels of vitamin D, using a hyperglycemic clamp technique, were sugar is given intravenously for 3 hours in order to keep the blood sugar level at 10 mmol/L. Those with low vitamin D levels will be randomized to treatment with vitamin D3 (cholecalciferol) 40 000 IU/week or placebo for 6 months before a new clamp is performed.

The study hypothesis is that persons with low vitamin D levels have impaired glucose handling which might be improved by vitamin D supplementation.


Options:
A: insulin secretion and sensitivity as assessed by an hyperglycemic clamp (6 months); intraocular pressure (6 months)
B: median time to next exacerbation. (1 year)
C: Bone Density of the hip
D: AUC for increment in serum 25(OH)D (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Contingency Management of Psychostimulant Abuse in the Severely Mentally Ill
Brief Summary: The purpose of this study is to determine the effectiveness of a behavioral treatment, contingency management, in reducing stimulant use in persons with serious mental illness.


Options:
A: Stimulant drug use as measured by urine analysis (Treatment phase: 12 weeks (3 measurements a week), Follow Up Phase: 3 months (1 measuresment a month))
B: abused drug abstinence measured by observed urine specimen testing weeks 1-52, and bimonthly months 13-18
C: Change from Baseline Craving for ATS assessed by Visual Analog Scales (VAS) at 1 month , 3 month and 6 months (Baseline, 1 month, 3 month and 6 months)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Contingency Management of Psychostimulant Abuse in the Severely Mentally Ill
Brief Summary: The purpose of this study is to determine the effectiveness of a behavioral treatment, contingency management, in reducing stimulant use in persons with serious mental illness.


Options:
A: Remission (Measured at Week 6 or 22)
B: Stimulant drug use as measured by urine analysis (Treatment phase: 12 weeks (3 measurements a week), Follow Up Phase: 3 months (1 measuresment a month))
C: BeckDepression Inventory : A questionnaire with 23 items to measure symptoms of depression
D: Number of Participants in Remission According to the Longitudinal Interval Follow-up Evaluation (LIFE) and the Hamilton Rating Scale for Depression (HRSD) (Through month 18 of treatment); Number of Participants in Recovery According to the LIFE and HRSD (Through 36 months of treatment); Number of Participants in Recurrence According to the LIFE and HRSD (Measured up to Month 36 from recovery)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Contingency Management of Psychostimulant Abuse in the Severely Mentally Ill
Brief Summary: The purpose of this study is to determine the effectiveness of a behavioral treatment, contingency management, in reducing stimulant use in persons with serious mental illness.


Options:
A: Stimulant drug use as measured by urine analysis (Treatment phase: 12 weeks (3 measurements a week), Follow Up Phase: 3 months (1 measuresment a month))
B: N/A
C: Change in Cocaine Use by Self Report (12 weeks); Change in Cocaine Use by Urine Toxicology Results (12 weeks)
D: abused drug abstinence measured by observed urine specimen testing weeks 1-52, and bimonthly months 13-18

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Contingency Management of Psychostimulant Abuse in the Severely Mentally Ill
Brief Summary: The purpose of this study is to determine the effectiveness of a behavioral treatment, contingency management, in reducing stimulant use in persons with serious mental illness.


Options:
A: Expired Carbon Monoxide (Baseline and treatment phases, 2-mont and 6-month follow up.)
B: Percent Medication Adherence at 3-month Follow-up Assessment (3-month assessment); Percent Medication Adherence at 12-month Follow-up Assessment (12-month follow-up assessment)
C: Targeted risk and protective factors, substance use, delinquency, violence (Baseline through thirteen-year follow-up (age 23)); CTC coalition functioning, prevention system transformation, evidence-based program (EBP) implementation (Baseline through eight-year follow-up (age 18))
D: Stimulant drug use as measured by urine analysis (Treatment phase: 12 weeks (3 measurements a week), Follow Up Phase: 3 months (1 measuresment a month))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Contingency Management of Psychostimulant Abuse in the Severely Mentally Ill
Brief Summary: The purpose of this study is to determine the effectiveness of a behavioral treatment, contingency management, in reducing stimulant use in persons with serious mental illness.


Options:
A: Percent negative CO readings; Percent negative cotinine readings; Longest period of continuous abstinence
B: Stimulant-free Weeks Assessed by Self-report and Twice-weekly Urine Drug Screens (Week 16)
C: verified abstinence 6 months (6 months)
D: Stimulant drug use as measured by urine analysis (Treatment phase: 12 weeks (3 measurements a week), Follow Up Phase: 3 months (1 measuresment a month))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Contingency Management of Psychostimulant Abuse in the Severely Mentally Ill
Brief Summary: The purpose of this study is to determine the effectiveness of a behavioral treatment, contingency management, in reducing stimulant use in persons with serious mental illness.


Options:
A: First recurrent suicide behavior (suicide attempted and completed suicide) (Minimum 1.5 year)
B: Repeated fatal or non fatal suicidal act (one year)
C: Stimulant drug use as measured by urine analysis (Treatment phase: 12 weeks (3 measurements a week), Follow Up Phase: 3 months (1 measuresment a month))
D: Negative symptoms, measured with Schedule for Assessment of Negative Symptoms in Schizophrenia, (SANS) (3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Contingency Management of Psychostimulant Abuse in the Severely Mentally Ill
Brief Summary: The purpose of this study is to determine the effectiveness of a behavioral treatment, contingency management, in reducing stimulant use in persons with serious mental illness.


Options:
A: Stimulant drug use as measured by urine analysis (Treatment phase: 12 weeks (3 measurements a week), Follow Up Phase: 3 months (1 measuresment a month))
B: Cognitive/Affective Functional Outcomes (Baseline, 6-month, 12-month and 18 month)
C: Substance use and function questionnaire (2 years)
D: Addiction severity

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse With Methadone Maintained Individuals
Brief Summary: We are testing to see if Galantamine, a learning enhancing medication, will help methadone maintained cocaine abusers with their learning and memory specific to CBT using an innovative CBT computer program.


Options:
A: Cocaine Use (12 weeks); Cocaine Abstinence (12 weeks)
B: Change from Baseline Craving for ATS assessed by Visual Analog Scales (VAS) at 1 month , 3 month and 6 months (Baseline, 1 month, 3 month and 6 months)
C: N/A
D: Non-concordant unprotected anal intercourse (Baseline, 6, 12, 18, 24 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Event-Driven Multicenter Study to Evaluate the Efficacy and Safety of Rivaroxaban in Subjects With a Recent Acute Coronary Syndrome
Brief Summary: The purpose of this study is to determine whether rivaroxaban in addition to standard care reduces the risk of the composite of cardiovascular death, myocardial infarction, or stroke in patients with a recent acute coronary syndrome compared with placebo.


Options:
A: The Composite Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Non-Inferiority) (Up to 4 years); The Composite of Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Superiority) (Up to 4 years); The Composite Event of Major/Non-major Clinically Relevant Bleeding Events: Primary Safety (Up to 4 years)
B: The Percentage of Patients With the Composite Endpoint of Cardiovascular Death, Myocardial Infarction, or Stroke (From the time of randomization (Day 1) up to completion of the treatment phase (Month 6))
C: Co-primary endpoints of Major Adverse Cardiovascular Events (MACE) and major bleeding (12 months)
D: Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death), Myocardial Infarction (MI) or Stroke Within 3 Years From Randomization (Randomization up to 47 months); Kaplan-Meier Estimate of the Percentage of Patients Who Experienced a TIMI Major Bleeding Within 3 Years From First Dose of Study Drug Units: Percentage of Patients (First dosing up to 48 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Event-Driven Multicenter Study to Evaluate the Efficacy and Safety of Rivaroxaban in Subjects With a Recent Acute Coronary Syndrome
Brief Summary: The purpose of this study is to determine whether rivaroxaban in addition to standard care reduces the risk of the composite of cardiovascular death, myocardial infarction, or stroke in patients with a recent acute coronary syndrome compared with placebo.


Options:
A: Event Rate of Cardiovascular Death, Myocardial Infarction, or Ischemic Stroke During the Intended Treatment Period - Randomized Participants (Randomization (Day 1) to first event (CV death, MI, ischemic stroke), up to March 2011, approximately 2 years); Event Rate of Confirmed Major Bleeding Using Thrombolysis in Myocardial Infarction (TIMI) Criteria During the Treatment Period - Treated Participants (From first dose to first occurrence of event (TIMI major bleeding) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years)
B: The Percentage of Patients With the Composite Endpoint of Cardiovascular Death, Myocardial Infarction, or Stroke (From the time of randomization (Day 1) up to completion of the treatment phase (Month 6))
C: The Composite Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Non-Inferiority) (Up to 4 years); The Composite of Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Superiority) (Up to 4 years); The Composite Event of Major/Non-major Clinically Relevant Bleeding Events: Primary Safety (Up to 4 years)
D: 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)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-centre, Randomised, Prospective, Single-blinded, Controlled Study to Investigate the Efficacy and Safety of a Standardised Maintenance Dosage Regimen of Intravenous Ferric Carboxymaltose (FERINJECT®) Versus Placebo in Patients With Iron Deficiency Caused by Inflammatory Bowel Disease
Brief Summary: The aim of this study is to evaluate the treatment of iron deficiency in IBD patients.


Options:
A: The primary endpoint of the IRON-HF study is to assess the impact of iron supplementation alone (IV or PO) on changes in oxygen maximal consumption (peak VO2) assessed by ergospirometry over a 3-month follow-up period.
B: Reduce red-cell transfusion packs (60 days after hospital discharge)
C: Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5 (Baseline (Day 1) through Week 5)
D: Efficacy of maintenance treatment of iron deficiency (8 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Two Different Treatment Strategies in Patients With Major Depressive Disorder Not Exhibiting Improvement on Escitalopram Treatment: Early vs. Delayed Intervention Strategy
Brief Summary: This study investigates two different approaches to the change in antidepressant treatment when an initial treatment is not effective: early intervention or delayed intervention.

Two hypothesis will be tested:

1. that time to confirmed response is shorter in the early intervention strategy vs. delayed intervention strategy
2. that the time to confirmed remission is shorter in the early intervention strategy compared to delayed intervention strategy.


Options:
A: Time to Confirmed Response by ≥ 50% Change From Baseline Reduction in the Hamilton Depression Rating Scale-17 Items (HAMD-17) (Week 4 through Week 16); Estimated Probability of Not Reaching Confirmed Response at 12 Weeks Based on the Survival Function for the Time to Confirmed Response (Week 4 through Week 16); Time to Confirmed Remission by a Hamilton Depression Rating Scale-17 Items (HAMD-17) Score of ≤ 7 That is Maintained for Two Consecutive Visits (Week 4 through Week 16); Estimated Probability of Not Reaching Confirmed Remission at 12 Weeks Based on the Survival Function for the Time to Confirmed Remission (Week 4 through Week 16)
B: Mean Change From the End of Phase A (Week 8 Visit) to Phase B (Week 14 Visit) in the Montgomery-Asberg Depression Rating Scale for the Efficacy Sample Set (Baseline and Week 14); Mean Change in MADRS Total Score From Baseline End of Week 8 to Week 14 for the Efficacy Sample Per Final Protocol (Baseline and Week 14)
C: To evaluate the efficacy of quetiapine fumarate sustained release; (Seroquel SR™) in combination with an antidepressant versus an antidepressant alone in patients with Major Depressive Disorder.
D: To evaluate the efficacy of quetiapine SR in combination with an antidepressant versus an antidepressant alone in MDD patients with inadequate response to an antidepressant treatment as assessed by the change from randomization to week 6 in the MADRS

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Placebo-controlled Study of Two Treatment Strategies Based on Tocilizumab (TCZ) With or Without Methotrexate (MTX) and Possible Addition of Other Disease-modifying Anti-rheumatic Drugs (DMARDs) in Patients...
Brief Summary: This 2 arm study will compare 2 treatment strategies based on tocilizumab in combination with methotrexate or placebo in patients with moderate to severe rheumatoid arthritis. Patients receiving methotrexate treatment will be randomized to receive either a) tocilizumab 8 mg intravenous (iv) every 4 weeks + methotrexate orally (po) weekly or b) tocilizumab 8 mg iv every 4 weeks + placebo po weekly. After the first 24 weeks of blinded treatment, treatment adjustments (increase or decrease of treatment intensity) may be introduced at intervals, based on response. The anticipated time on study treatment is up to 3 years, and the target sample size is approximately 470 patients.


Options:
A: Percentage of Participants With Disease Activity Score 28 Joints (DAS28) Remission at Week 24 (Week 24)
B: Percentage of Patients With an Improvement of at Least 50% in American College of Rheumatology (ACR) Score (ACR50) From Baseline at Week 24 (Baseline to Week 24)
C: Percentage of Participants Who Responded to ≥ 6 of 12 Anti-pneumococcal Antibody Serotypes (Baseline (Week 3) and Week 8 (5 weeks post-vaccination))
D: American College of Rheumatology 20% (ACR20) Response at Week 12 (Baseline, Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Placebo-controlled Study of Two Treatment Strategies Based on Tocilizumab (TCZ) With or Without Methotrexate (MTX) and Possible Addition of Other Disease-modifying Anti-rheumatic Drugs (DMARDs) in Patients...
Brief Summary: This 2 arm study will compare 2 treatment strategies based on tocilizumab in combination with methotrexate or placebo in patients with moderate to severe rheumatoid arthritis. Patients receiving methotrexate treatment will be randomized to receive either a) tocilizumab 8 mg intravenous (iv) every 4 weeks + methotrexate orally (po) weekly or b) tocilizumab 8 mg iv every 4 weeks + placebo po weekly. After the first 24 weeks of blinded treatment, treatment adjustments (increase or decrease of treatment intensity) may be introduced at intervals, based on response. The anticipated time on study treatment is up to 3 years, and the target sample size is approximately 470 patients.


Options:
A: Percentage of Participants With Disease Activity Score 28 Joints (DAS28) Remission at Week 24 (Week 24)
B: Percentage of Patients With an American College of Rheumatology 20 (ACR20) Response at Week 24 (Baseline to Week 24)
C: Double-blind Period: Mean Synovitis Scores at Baseline As Measured by the Rheumatoid Arthritis Clinical Trials 6 (OMERACT 6) Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) (At baseline); Double-blind Period: Mean Change From Baseline in OMERACT 6 Wrist Synovitis Score: Planned Analysis Using Non-Parametric ANCOVA (Baseline to Day 113); Double-blind Period: Mean Change From Baseline in OMERACT 6 Wrist Synovitis Score: Post Hoc Sensitivity Analysis Using Parametric ANCOVA Analysis (Baseline to Day 113)
D: N/A

Answer: A