TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Olanzapine in Patients With Borderline Personality Disorder: A Randomized Flexible Dose Double-Blind Comparison With Placebo
Brief Summary: The goals of this study are to determine: the safety of olanzapine and any side effects that might be associated with it, how olanzapine compares to placebo, whether olanzapine can help patients with symptoms of Borderline Personality Disorder (BPD), and how much olanzapine should be given to patients.


Options:
A: To assess the efficacy of olanzapine therapy (2.5 to 20.0 mg/day) compared with placebo in patients greater than or; equal to 18 years of age, with a diagnosis of BPD as defined by DSM-IV-TR criteria, in improving overall symptomatology as measured by the mean last observation; carried forward (LOCF) change in the ZAN-BPD; total score in up to 12 weeks of double-blind treatment.
B: CGI scale for use in borderline personality disorder (CGI-BPD) (12 weeks)
C: assessing change in number of suicide attempts/self-harming acts (baseline, 0, 12, 24 and 52 weeks after the start of the inpatient treatment)
D: Score of the Borderline Personality Disorder Severity Index (BPDSI) - The BPDSI is a semi-structured interview assessing the frequency and severity of manifestations of borderline personality disorder (BPD) during the last three months. (Changes from baseline to 3, 6 and 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Olanzapine in Patients With Borderline Personality Disorder: A Randomized Flexible Dose Double-Blind Comparison With Placebo
Brief Summary: The goals of this study are to determine: the safety of olanzapine and any side effects that might be associated with it, how olanzapine compares to placebo, whether olanzapine can help patients with symptoms of Borderline Personality Disorder (BPD), and how much olanzapine should be given to patients.


Options:
A: Zanarini Scale for Borderline personality disorder (ZAN-BPD) (8 weeks)
B: Change in Recovery Assessment Scale (Change from baseline in Recovery Assessment Scale at 12th meeting (6 up to 12 weeks))
C: To assess the efficacy of olanzapine therapy (2.5 to 20.0 mg/day) compared with placebo in patients greater than or; equal to 18 years of age, with a diagnosis of BPD as defined by DSM-IV-TR criteria, in improving overall symptomatology as measured by the mean last observation; carried forward (LOCF) change in the ZAN-BPD; total score in up to 12 weeks of double-blind treatment.
D: Change on the severity of borderline personality disorder measured by Borderline Personality Symptom List (BSL-23). (Baseline and up to 12 months after inclusion.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Bosentan in Patients With Mildly Symptomatic Pulmonary Arterial Hypertension (PAH)
Brief Summary: The present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) Class III and IV, to patients suffering from PAH Class II.


Options:
A: Change from Baseline to End of Study in 6MWT distance. A mean difference from placebo of at least 35 m is considered clinically relevant. (16 weeks)
B: Peak 6-minute Walk Distance (12 weeks)
C: exercise capacity (Baseline to end of study); cardiac hemodynamics (Baseline to end of study)
D: Change from baseline at Week 12 of six minute walk distance

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Bosentan in Patients With Mildly Symptomatic Pulmonary Arterial Hypertension (PAH)
Brief Summary: The present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) Class III and IV, to patients suffering from PAH Class II.


Options:
A: Mean Pulmonary Arterial Pressure Change From Baseline (baseline, 6 months)
B: Change From Baseline to End of Double-blind Treatment in Sitting Diastolic Blood Pressure at Trough (Baseline (Day 1) and end of double-blind treatment (Day 56))
C: 6 minutes walking distance
D: exercise capacity (Baseline to end of study); cardiac hemodynamics (Baseline to end of study)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Darbepoetin Alfa for the Treatment of Anemia of Cancer
Brief Summary: The purpose of this study is to evaluate the efficacy of darbepoetin alfa versus placebo in reducing the occurrences of red blood cell transfusions in subjects with anemia of cancer who are not receiving chemotherapy.


Options:
A: Incidence of red blood cell (RBC) transfusion from week 5 to End of Treatment Period (EOTP) (from week 5 to EOTP)
B: Occurrences of red blood cell transfusion (from study day 29 (week 5) to week 17)
C: Proportion of Patients With Major Erythroid Response (MER) (Assessed after completion of 16 weeks of treatment)
D: Incidence of adverse events (throughout study)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Darbepoetin Alfa for the Treatment of Anemia of Cancer
Brief Summary: The purpose of this study is to evaluate the efficacy of darbepoetin alfa versus placebo in reducing the occurrences of red blood cell transfusions in subjects with anemia of cancer who are not receiving chemotherapy.


Options:
A: Change in the patient-reported Pediatric Quality of Life Inventory (PedsQL Inventory) from baseline to the last assessment.
B: Incidence of adverse events (throughout study)
C: Incidence of red blood cell (RBC) transfusion from week 5 to End of Treatment Period (EOTP) (from week 5 to EOTP)
D: Occurrences of red blood cell transfusion (from study day 29 (week 5) to week 17)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Darbepoetin Alfa for the Treatment of Anemia of Cancer
Brief Summary: The purpose of this study is to evaluate the efficacy of darbepoetin alfa versus placebo in reducing the occurrences of red blood cell transfusions in subjects with anemia of cancer who are not receiving chemotherapy.


Options:
A: Incidence of adverse events (throughout study)
B: The primary objective of this study is to demonstrate that the administration of epoetin alfa to critically ill subjects reduces the proportion of subjects requiring red blood cell (RBC) transfusion as compared with placebo at Study Day 29.
C: Change in the patient-reported Pediatric Quality of Life Inventory (PedsQL Inventory) from baseline to the last assessment.
D: Occurrences of red blood cell transfusion (from study day 29 (week 5) to week 17)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of Epoetin Alfa in Critically Ill Subjects
Brief Summary: Erythropoietin (EPO) is a hormone produced in the kidney. Its function is to stimulate the production of red cells in the bone marrow. The purpose of this research study is to demonstrate that the administration EPO to critically ill subjects in the intensive care unit (ICU) reduces the number of patients requiring red blood cell (RBC) transfusion as compared with placebo (a liquid without active medicine).


Options:
A: The primary objective of this study is to demonstrate that the administration of epoetin alfa to critically ill subjects reduces the proportion of subjects requiring red blood cell (RBC) transfusion as compared with placebo at Study Day 29.
B: The primary outcome will be a composite consisting of mortality (all cause), myocardial infarction, stroke, and CHF hospitalization (not including those hospitalizations during which RRT occurs)
C: Incidence of adverse events (throughout study)
D: Change in the patient-reported Pediatric Quality of Life Inventory (PedsQL Inventory) from baseline to the last assessment.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of Epoetin Alfa in Critically Ill Subjects
Brief Summary: Erythropoietin (EPO) is a hormone produced in the kidney. Its function is to stimulate the production of red cells in the bone marrow. The purpose of this research study is to demonstrate that the administration EPO to critically ill subjects in the intensive care unit (ICU) reduces the number of patients requiring red blood cell (RBC) transfusion as compared with placebo (a liquid without active medicine).


Options:
A: Number of patients reaching a CPC (cerebral performance category) level 1 in each group (at day 60)
B: Changes in infarct size as assessed by magnetic resonance imaging 3 months after administration of study medication (within 3-7 days of administration of study medication)
C: Magnetic resonance imaging (MRI) determination of infarct size (12 weeks)
D: The primary objective of this study is to demonstrate that the administration of epoetin alfa to critically ill subjects reduces the proportion of subjects requiring red blood cell (RBC) transfusion as compared with placebo at Study Day 29.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial to Evaluate 2 Hours of Daily Patching for Amblyopia in Children 3 to <7 Years Old
Brief Summary: The objectives of the Spectacle Phase are:

* In previously untreated pure anisometropic patients (i.e. patients who have not used spectacles in the last year and who do not have strabismus), to determine

  1. the incidence of resolution of amblyopia with spectacle correction alone and
  2. the time course of visual acuity improvement with spectacle correction alone.
* In all other patients, to achieve maximal improvement with spectacle correction prior to entering the randomized trial.

The objectives of the Randomized Trial are:

* To determine whether 5 weeks of patching treatment (2 hours of patching per day of the sound eye combined with at least one concurrent hour of near activities), compared with a control group (using spectacle correction only), improves visual acuity in patients with moderate to severe amblyopia (20/40 to 20/400).
* To determine the maximal improvement and time course of improvement with this patching treatment regimen.


Options:
A: Visual acuity in the amblyopic eye (6 months)
B: Visual acuity (8 weeks)
C: Visual Acuity Mean Score in the Amblyopic Eye (18 weeks); Visual Acuity Distribution in the Amblyopic Eye (18 weeks); Mean Change in Visual Acuity in the Amblyopic Eye (baseline to 18 weeks); Distribution of Change in Visual Acuity in the Amblyopic Eye (baseline to 18 weeks)
D: maximal improvement in visual acuity

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial to Evaluate 2 Hours of Daily Patching for Amblyopia in Children 3 to <7 Years Old
Brief Summary: The objectives of the Spectacle Phase are:

* In previously untreated pure anisometropic patients (i.e. patients who have not used spectacles in the last year and who do not have strabismus), to determine

  1. the incidence of resolution of amblyopia with spectacle correction alone and
  2. the time course of visual acuity improvement with spectacle correction alone.
* In all other patients, to achieve maximal improvement with spectacle correction prior to entering the randomized trial.

The objectives of the Randomized Trial are:

* To determine whether 5 weeks of patching treatment (2 hours of patching per day of the sound eye combined with at least one concurrent hour of near activities), compared with a control group (using spectacle correction only), improves visual acuity in patients with moderate to severe amblyopia (20/40 to 20/400).
* To determine the maximal improvement and time course of improvement with this patching treatment regimen.


Options:
A: maximal improvement in visual acuity
B: Visual acuity improvement
C: Visual acuity
D: Visual acuity (8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Insulin Resistance Intervention After Stroke (IRIS) Trial
Brief Summary: The purpose of this study is to determine if pioglitazone is effective in preventing future strokes or heart attacks among non-diabetic persons who have had a recent ischemic stroke.


Options:
A: Reduction in systolic blood pressure (1 year)
B: Recurrent Fatal or Non-fatal Stroke, or Fatal or Non-fatal Myocardial Infarction (Up to 5 years)
C: Blood Pressure (12 months)
D: Difference in physical activity scale for the elderly (24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Insulin Resistance Intervention After Stroke (IRIS) Trial
Brief Summary: The purpose of this study is to determine if pioglitazone is effective in preventing future strokes or heart attacks among non-diabetic persons who have had a recent ischemic stroke.


Options:
A: Development of Diabetes. (Outcomes were assessed from 1996-2008 (approximately 12 years including 6 years of DPP).); Prevalence of Aggregate Microvascular Complication (Outcomes were assessed from 2012-2013 (approximately 2 years).); Total Cancer Except Non-melanoma Skin Cancer (Outcomes were assessed from 1996-2020 (approximately 24 years).); Major Adverse Cardiovascular Events (MACE): Myocardial Infarction (MI), Stroke, or Cardiovascular Death (CVD) (Outcomes were assessed from 1996-2025 (approximately 29 years).)
B: Percent Change From Baseline to Month 12 in Bone Mineral Density in the Total Proximal Femur by Dual-Energy-Ray Absorptiometry (DXA) (Baseline and Month 12.)
C: Recurrent Fatal or Non-fatal Stroke, or Fatal or Non-fatal Myocardial Infarction (Up to 5 years)
D: Liver Histology (Using Kleiner et al Criteria, Hepatology 2005) (At 18 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Insulin Resistance Intervention After Stroke (IRIS) Trial
Brief Summary: The purpose of this study is to determine if pioglitazone is effective in preventing future strokes or heart attacks among non-diabetic persons who have had a recent ischemic stroke.


Options:
A: Number of Participants With the Indicated Components of the Composite Cardiovascular Outcome for Thiazolidinedione (TZD) (From Randomization at Visit 3 up to the Final Visit (average of 162 days)); Number of Participants With the Indicated Components of the Composite Outcome for Vitamin D (From Randomization at Visit 3 to Final Visit (up to 162 days))
B: Recurrent Fatal or Non-fatal Stroke, or Fatal or Non-fatal Myocardial Infarction (Up to 5 years)
C: Time to the Composite of All Cause Mortality, Non-Fatal Myocardial Infarction, Stroke, Acute Coronary Syndrome, Major Leg Amputation, Cardiac Intervention, Bypass Surgery or Leg Revascularization. (At First Occurrence)
D: Effect on cardiovascular death, non-fatal myocardial infarction and non-fatal stroke (Throughout study, approximately 4.5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Depression Following Bypass Surgery
Brief Summary: The purpose of this study is to treat depression in patients who have undergone coronary artery bypass graft (CABG).


Options:
A: Generic Mental Health-Related Quality of Life (Measured 8 months post-CABG)
B: Change in Hospital Anxiety and Depression Scale (HADS) (Baseline pre treatment, four-month post baseline)
C: Perceived control measure by Control Attitude Scale (3 months)
D: Rates of Adequate Depression Treatment at Discharge (5 days after enrollment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Depression Following Bypass Surgery
Brief Summary: The purpose of this study is to treat depression in patients who have undergone coronary artery bypass graft (CABG).


Options:
A: Mean SCL-20 depression scores (6 & 12 months post-baseline); Depression treatment response, defined as greater than 50% decrease in SCL-20 score from baseline (6 & 12 months post-baseline); Complete depression remission defined as SCL-20 score less than 0.5. (6 & 12 months post-baseline)
B: Generic Mental Health-Related Quality of Life (Measured 8 months post-CABG)
C: N/A
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Depression Following Bypass Surgery
Brief Summary: The purpose of this study is to treat depression in patients who have undergone coronary artery bypass graft (CABG).


Options:
A: Re-hospitalization and death rates (Measured at Month 12); Total hospitalizations (Measured at Month 12); HF-specific quality of life (Measured at Months 6 and 12)
B: Changes from baseline to 18 months in depressive symptoms (HADS-D) (18 months)
C: Levels of proinflammatory cytokines (IL-1 and IL-6) (at baseline and after 8 weeks (at the completion of the intervention)); The soluble receptor for IL-6 (sIL-6) (at baseline and after 8 weeks (at the completion of the intervention)); Inflammatory markers c-reactive protein (CRP and sICAM-1) (at baseline and after 8 weeks (at the completion of the intervention))
D: Generic Mental Health-Related Quality of Life (Measured 8 months post-CABG)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Depression Following Bypass Surgery
Brief Summary: The purpose of this study is to treat depression in patients who have undergone coronary artery bypass graft (CABG).


Options:
A: Physical activity: measured at baseline (day of hospital discharge), 6 months and 12 months via: (Baseline, 6 and 12 months)
B: Phase 1: patient who've received interventions based on evidence proportion informed by the indicators (9 months); Phase 2: increase of prescription of evidence based treatment in clinical practice (6 months)
C: Duration and Intensity of Physical Activity (1 month, 3 months and 12 months after discharge)
D: Generic Mental Health-Related Quality of Life (Measured 8 months post-CABG)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Depression Following Bypass Surgery
Brief Summary: The purpose of this study is to treat depression in patients who have undergone coronary artery bypass graft (CABG).


Options:
A: Health-related Quality of Life - Mental Health Component Score (Change from Baseline in Quality of Life at 12-months); Reduced Mood Disorder Symptoms (Change from Baseline in Mood Disorder Symptoms at 12-months)
B: Generic Mental Health-Related Quality of Life (Measured 8 months post-CABG)
C: Veterans RAND-12 Mental Component Score (VR-12 MCS) (one year)
D: Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c (Baseline to 12 months); Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); Systolic Blood Pressure at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); LDL Cholesterol at Baseline and 12 Months (Measured at Baseline and 12 months); Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 months and 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Depression Following Bypass Surgery
Brief Summary: The purpose of this study is to treat depression in patients who have undergone coronary artery bypass graft (CABG).


Options:
A: Change in Depression (difference between the intervention and the control group) (At baseline and 3 months later (after intervention)); Change in Anxiety (difference between the intervention and the control group) (At baseline and 3 months later (after intervention))
B: Stage of change for coronary heart disease patients with depression (2 - days (T0) before discharge.); Process of change for coronary heart disease patients with depression (2 - days (T0) before discharge.); Decisional balance for coronary heart disease patients with depression (2 - days (T0) before discharge.); Self-efficacy for coronary heart disease patients with depression: scale (2 - days (T0) before discharge.); Hamilton Rating Scale for Depression (2 - days (T0) before discharge.)
C: Generic Mental Health-Related Quality of Life (Measured 8 months post-CABG)
D: Low-density lipoprotein (LDL)cholesterol (Baseline and 12 months); Blood pressure (baseline and 12 months); Body Mass Index (baseline and 12 months); Psychological Well-Being (Baseline and 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Program to Reduce Incontinence by Diet and Exercise
Brief Summary: PRIDE will evaluate the impact of weight loss on urinary incontinence in a randomized, controlled trial.


Options:
A: Changes in anthropometry (BMI, waist and hip cf) (3 years); Maximal oxygen uptake (VO2max) (3 years); Health-related quality of life (EQ 5D, SF-36) (3 years); Self-reported physical activity (3 years)
B: Carotid Intima Media Thickness (baseline and 12 months); Waist Circumference (baseline and 12 months); High Density Lipoprotein (HDL) (baseline and 12 months); Glucose (baseline and 12 months); Systolic Blood Pressure (baseline and 12 months); Coronary Artery Calcium Score (baseline and 12 months)
C: Change in the number of incontinent episodes (6 months)
D: area under the curve for glucose (AUC Glucose0-120) at the oral glucose tolerance test at baseline, 3 months and 6 months; area under the curve for insulin (AUC Insulin0-120) at the oral glucose tolerance test at baseline, 3 months and 6 months; HbA1C at baseline, 3 months and 6 months; weight at baseline, 3 months and 6 months; waist circumference at baseline, 3 months and 6 months

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Program to Reduce Incontinence by Diet and Exercise
Brief Summary: PRIDE will evaluate the impact of weight loss on urinary incontinence in a randomized, controlled trial.


Options:
A: recovery of urinary continence (one year); recovery of erectile function (two years)
B: Effects of transcutaneous perineal stimulation compared to anal stimulation (Baseline, 6 and 10 weeks)
C: Recovery of urinary continence (postoperative 1 month)
D: Change in the number of incontinent episodes (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Program to Reduce Incontinence by Diet and Exercise
Brief Summary: PRIDE will evaluate the impact of weight loss on urinary incontinence in a randomized, controlled trial.


Options:
A: urgencyepisodes (after 2 month (end of study)); urgeincontinence (after 2 month (studyend)); VAS score from ICI_OAB_Q (after 2 month (studyend))
B: Change in the number of incontinent episodes (6 months)
C: Proportion of Women Who Meet Definition of Success (8 months)
D: Urogenital Distress Inventory (UDI-6) (baseline to 6 or 8 weeks); Incontinence Impact Questionnaire (IIQ-7) (baseline to 6 or 8 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Program to Reduce Incontinence by Diet and Exercise
Brief Summary: PRIDE will evaluate the impact of weight loss on urinary incontinence in a randomized, controlled trial.


Options:
A: Change in the number of incontinence episodes over 7 days, with 95% confidence intervals, between baseline and 6 weeks (6 weeks)
B: Change in the number of incontinent episodes (6 months)
C: Weight gain during pregnancy (From 14 weeks pregnancy to delivery)
D: First Occurrence of a Severe Cardiovascular Event (up to 11 years)

Answer: B