TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind Comparison of LY2140023, Olanzapine, and Placebo in the Treatment of Patients With Schizophrenia
Brief Summary: Assess the efficacy of a new drug (a receptor agonist that modulates the glutamatergic activity) in the treatment of schizophrenia.

The primary objective of this study is to determine if a mGlu2/3 agonist dosed for 28 days is superior to placebo in the treatment of patients with schizophrenia as measured by the Positive and Negative Symptom Scales (PANSS) total score.


Options:
A: Positive and Negative Syndrome Scale (PANSS) total score (over 4 weeks of treatment)
B: Time to Relapse or Impending Relapse (Up to 26 weeks post-randomization)
C: Composite MATRICS Consensus Cognitive Battery Score (4 weeks)
D: To determine if a mGlu2/3 agonist (LY2140023) dosed for 28 days is superior to placebo in the treatment of patients with schizophrenia as measured by the Positive and Negative Symptom Scales (PANSS) total score (28 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Can Pro-brain-natriuretic Peptide Guided Therapy of Chronic Heart Failure Improve Heart Failure Morbidity and Mortality?
Brief Summary: The purpose of this study is to determine whether NT-proBNP guided treatment of chronic congestive heart failure will reduce heart failure related morbidity and mortality compared to therapy guided by standard clinical judgement.


Options:
A: CV Death or Heart Failure Hospitalization (24 Months)
B: Difference in total number of days alive and outside the hospital between the NT-proBNP guided and the clinical guided group. (minimum of one year)
C: Prevalence and severity of LVD (5 year)
D: Number of Participants With First Occurrence of Any Component of the Composite of Major Adverse Cardiovascular Events (Cardiovascular [CV] Death, Non-fatal Myocardial Infarction [MI] or Non-fatal Stroke) During the Time Period for Follow-up of CV Events (From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Can Pro-brain-natriuretic Peptide Guided Therapy of Chronic Heart Failure Improve Heart Failure Morbidity and Mortality?
Brief Summary: The purpose of this study is to determine whether NT-proBNP guided treatment of chronic congestive heart failure will reduce heart failure related morbidity and mortality compared to therapy guided by standard clinical judgement.


Options:
A: Prevalence and severity of LVD (5 year)
B: Effect of Standard of Care therapy versus Standard of Care plus NT-proBNP targeted therapy on total cardiovascular events (One year)
C: To use the Triage touch to determine the optimal frequency of home BNP testing and the changes in BNP concentrations that correlate with clinical HF decompensations and related adverse events in at-risk HF patients. (Day 5, Day 30 and Day 60)
D: Difference in total number of days alive and outside the hospital between the NT-proBNP guided and the clinical guided group. (minimum of one year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Social Support and Education in Asthma Follow-up (SSEA)
Brief Summary: We will evaluate the effect of an eighteen-month asthma coaching intervention for parents/caregivers of children with asthma to reduce asthma morbidity. The primary objective is to determine if asthma coaching will significantly reduce asthma morbidity as measured by a reduction in the number of ED visits and hospitalizations for the children during the 18 months of active coaching and during the 18 months after the coaching stops.

We will provide half of the subjects (parents/caregivers) with access to assistance from an asthma coach for 18 months (including 2 contacts with an asthma nurse during the first 6 months). The other half of the subjects will not have an asthma coach, but their children will have their usual routine care with their primary care providers. The nurse and coach will help the subjects learn more about caring for their children's asthma and improving interactions with the primary care providers for their children.


Options:
A: ER visits (18 months)
B: Change in FDI (Functional Disability Inventory) Scores at End of Study (Baseline and 6 months (end of study))
C: Adherence (beginning at baseline - week 20)
D: Metabolic Control: Hemoglobin A1c (HbA1c) (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Social Support and Education in Asthma Follow-up (SSEA)
Brief Summary: We will evaluate the effect of an eighteen-month asthma coaching intervention for parents/caregivers of children with asthma to reduce asthma morbidity. The primary objective is to determine if asthma coaching will significantly reduce asthma morbidity as measured by a reduction in the number of ED visits and hospitalizations for the children during the 18 months of active coaching and during the 18 months after the coaching stops.

We will provide half of the subjects (parents/caregivers) with access to assistance from an asthma coach for 18 months (including 2 contacts with an asthma nurse during the first 6 months). The other half of the subjects will not have an asthma coach, but their children will have their usual routine care with their primary care providers. The nurse and coach will help the subjects learn more about caring for their children's asthma and improving interactions with the primary care providers for their children.


Options:
A: Change in FDI (Functional Disability Inventory) Scores at End of Study (Baseline and 6 months (end of study))
B: Metabolic Control: Hemoglobin A1c (HbA1c) (2 years)
C: Parental asthma-related quality of life (one year); Urgent care events for asthma (One year)
D: ER visits (18 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Social Support and Education in Asthma Follow-up (SSEA)
Brief Summary: We will evaluate the effect of an eighteen-month asthma coaching intervention for parents/caregivers of children with asthma to reduce asthma morbidity. The primary objective is to determine if asthma coaching will significantly reduce asthma morbidity as measured by a reduction in the number of ED visits and hospitalizations for the children during the 18 months of active coaching and during the 18 months after the coaching stops.

We will provide half of the subjects (parents/caregivers) with access to assistance from an asthma coach for 18 months (including 2 contacts with an asthma nurse during the first 6 months). The other half of the subjects will not have an asthma coach, but their children will have their usual routine care with their primary care providers. The nurse and coach will help the subjects learn more about caring for their children's asthma and improving interactions with the primary care providers for their children.


Options:
A: Emergency Department Visits - 1st time point (12 months prior to baseline interview); Emergency Department Visits - 2nd time point (Interval between baseline and 9 months); Emergency Department Visits - 3rd time point (interval between 9 month and 18 month telephone interview)
B: Follow-up with a Primary Care Physician (PCP) (4 weeks, 3 months and 6 months after Emergency Department visit)
C: medication adherence (on year)
D: ER visits (18 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Social Support and Education in Asthma Follow-up (SSEA)
Brief Summary: We will evaluate the effect of an eighteen-month asthma coaching intervention for parents/caregivers of children with asthma to reduce asthma morbidity. The primary objective is to determine if asthma coaching will significantly reduce asthma morbidity as measured by a reduction in the number of ED visits and hospitalizations for the children during the 18 months of active coaching and during the 18 months after the coaching stops.

We will provide half of the subjects (parents/caregivers) with access to assistance from an asthma coach for 18 months (including 2 contacts with an asthma nurse during the first 6 months). The other half of the subjects will not have an asthma coach, but their children will have their usual routine care with their primary care providers. The nurse and coach will help the subjects learn more about caring for their children's asthma and improving interactions with the primary care providers for their children.


Options:
A: ER visits (18 months)
B: Parent report measures (5 years); Teen self-report measures (5 years)
C: symptoms of recurrent abdominal pain (measured one week following treatment and again in 3, 6 and 12 months); disability (measured one week following treatment and again in 3, 6 and 12 months)
D: Parent Report Measures (4 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: To improve asthma outcomes by developing and evaluating strategies for enhancing the clinic-patient partnership. To develop a model of shared decision-making for asthma treatment, and to evaluate it in a two-year randomized clinical trial in 342 adults aged 18-70 years with sub-optimally controlled persistent asthma.


Options:
A: Change in walking activity from admission to discharge from rehabilitation (Admission and discharge from in-patient rehabilitation (approx. 4-6 weeks)); Change in control of walking (Admission and discharge from in-patient rehabilitation (approx. 4-6 weeks))
B: N/A
C: N/A
D: Change in performance on COPM (pre, post, 3 month follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: To improve asthma outcomes by developing and evaluating strategies for enhancing the clinic-patient partnership. To develop a model of shared decision-making for asthma treatment, and to evaluate it in a two-year randomized clinical trial in 342 adults aged 18-70 years with sub-optimally controlled persistent asthma.


Options:
A: Asthma Quality of Life Questionnaire (Baseline, 6 weeks, 3 months, 6 months)
B: N/A
C: N/A
D: Symptom-free days; Quality of Life Questionnaire (AQLQ, PAQLQ); Rate of asthma-related hospitalizations over 18 months of enrollment; Rate of asthma-related emergency room (ER) visits over 18 months of enrollment

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: To improve asthma outcomes by developing and evaluating strategies for enhancing the clinic-patient partnership. To develop a model of shared decision-making for asthma treatment, and to evaluate it in a two-year randomized clinical trial in 342 adults aged 18-70 years with sub-optimally controlled persistent asthma.


Options:
A: Change from baseline in asthma knowledge at 2 months, measured by QCALF score (Visit 1 (baseline) and visit 2 (2-month follow-up)); Change from baseline in decisional conflict at 2 months, measured by DCS score (Visit 1 (baseline) and visit 2 (2-month follow-up))
B: N/A
C: quality of life (9 months)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: To improve asthma outcomes by developing and evaluating strategies for enhancing the clinic-patient partnership. To develop a model of shared decision-making for asthma treatment, and to evaluate it in a two-year randomized clinical trial in 342 adults aged 18-70 years with sub-optimally controlled persistent asthma.


Options:
A: N/A
B: MEMS Adherence (12 months follow up)
C: Percentage of Participants With Depression Treatment Response (6 months)
D: Virologic suppression at 6 months (6 months); Virologic failure at all time intervals from ART initiation (these primary outcomes added to expanded trial protocol November 2007) (Typically every 24 weeks); Adherence measured by pill counts (this primary outcome added to expanded trial protocol November 2007) (Typically weekly to monthly)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: To improve asthma outcomes by developing and evaluating strategies for enhancing the clinic-patient partnership. To develop a model of shared decision-making for asthma treatment, and to evaluate it in a two-year randomized clinical trial in 342 adults aged 18-70 years with sub-optimally controlled persistent asthma.


Options:
A: change in asthma control between baseline and six months as measured by ACQ.24 The ACQ measures clinical goals of asthma management on a scale: 0 (good control) to 6, is responsive to change,24 with a intra-individual minimum important difference (6 months)
B: N/A
C: Number of Participants With Unscheduled Use of Healthcare (1 year)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: To improve asthma outcomes by developing and evaluating strategies for enhancing the clinic-patient partnership. To develop a model of shared decision-making for asthma treatment, and to evaluate it in a two-year randomized clinical trial in 342 adults aged 18-70 years with sub-optimally controlled persistent asthma.


Options:
A: Adherence rate to daily inhaled steroids, reported as the ratio of the sum of number of recorded over prescribed activation per day during the 28 days following the index visit.
B: N/A
C: N/A
D: Change in baseline asthma self efficacy after 3 weeks (participants will be followed for an average of 4 weeks, with this measure collect at the beginning of the period and after 3 weeks of reminders.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: To improve asthma outcomes by developing and evaluating strategies for enhancing the clinic-patient partnership. To develop a model of shared decision-making for asthma treatment, and to evaluate it in a two-year randomized clinical trial in 342 adults aged 18-70 years with sub-optimally controlled persistent asthma.


Options:
A: Processes of clinical care for diabetes; Cardiovascular risk as determined by UKPDS Risk; Metabolic outcomes (HgbA1c); Metabolic outcomes (LDL Cholesterol); Metabolic Outcomes (Systolic Blood Pressure)
B: N/A
C: Blood pressure at target level (140/85 or lower), total cholesterol at target level (4.5 mmol/l or lower), LDL cholesterol at target level (2.5 mmol/l or below), waist circumference at target level (<=94 men, <=80 cm women) (12 months from start of intervention); For patients with diabetes: blood HbA1c at target level (7% or less) (12 months from start of intervention)
D: HbA1c level (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: To improve asthma outcomes by developing and evaluating strategies for enhancing the clinic-patient partnership. To develop a model of shared decision-making for asthma treatment, and to evaluate it in a two-year randomized clinical trial in 342 adults aged 18-70 years with sub-optimally controlled persistent asthma.


Options:
A: N/A
B: Trough (AM pre-dose and pre-rescue bronchodilator) FEV1 (at the end of the 6 week treatment period.)
C: Oral montelukast is associated with reduced school absences in comparison to inhaled salmeterol over a period of 1 year in Arg/Arg-16 asthmatic children (Every 3 months)
D: Morning Peak Expiratory Flow

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: To improve asthma outcomes by developing and evaluating strategies for enhancing the clinic-patient partnership. To develop a model of shared decision-making for asthma treatment, and to evaluate it in a two-year randomized clinical trial in 342 adults aged 18-70 years with sub-optimally controlled persistent asthma.


Options:
A: Morning peak expiratory flow
B: Maximum Post-exercise Percent (%) Fall in FEV1 (4 weeks (Weeks 0 to 4 or Weeks 6 to 10))
C: N/A
D: Treatment Failure (16 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Zinc Therapy in Zinc Deficient HIV Positive Drug Users
Brief Summary: Zinc deficiency is prevalent in HIV infected individuals who abuse drugs. The purpose of this study is to determine if zinc therapy will prevent immune failure in HIV infected individuals who abuse drugs and have low plasma zinc levels.


Options:
A: Reduction in duration of diarrhoea; Reeudction in total stool volume
B: Preventive effect of zinc therapy on diarrhoea during the subsequent three month 14 days of enrollment; Assess the acceptability of zinc therapy during diarrhoea in young children.
C: Immune failure (For at least 6 months)
D: Change in length and length-for-age Z-score (9 to 18 mo of age); Change in weight and weight-for-age Z-score (9 to 18 mo of age); Incidence of diarrhea and laboratory-confirmed malaria infection (9 to 18 mo of age); Change in plasma zinc concentration (9 to 18 mo of age); Change in body composition (9 to 18 mo of age)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Zinc Therapy in Zinc Deficient HIV Positive Drug Users
Brief Summary: Zinc deficiency is prevalent in HIV infected individuals who abuse drugs. The purpose of this study is to determine if zinc therapy will prevent immune failure in HIV infected individuals who abuse drugs and have low plasma zinc levels.


Options:
A: Safety (12 weeks); Efficacy of the Two Doses (4000 and 7000 IU/d) (12 weeks)
B: Weight Gain (18 months); Immune Reconstitution (18 months); Improved Quality of Life (18 months)
C: Immune failure (For at least 6 months)
D: Change in Endothelial Function (Baseline and 12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Soft Drink, Milk and Obesity in Chilean Children
Brief Summary: The primary aim of this randomized controlled trial is to evaluate the effects of replacing habitual consumption of sugar-sweetened soft drinks with milk over 16 weeks.


Options:
A: Change in percent body fat by DXA scan
B: Change in physical activity (Participants' physical activity will be measure over the course of 5 consecutive school days pre-intervention and 5 consecutive school days post-intervention)
C: Purchase of sugar-sweetened beverages (4 months)
D: Body Mass Index score(BMI sds) at the age 6 years to monitor the effectiveness of the intervention (5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Adolescents With Anorexia Nervosa
Brief Summary: This study will compare the effectiveness of family-based therapy versus individual psychotherapy for the treatment of adolescent anorexia nervosa.


Options:
A: Scores on the Eating Disorders Examination (Measured at Year 1 of treatment and Year 1 of follow-up)
B: Percent Ideal Body Weight (%IBW) (9-months and 21-months)
C: Diet Energy Density and Variety score (Measured before treatment and at Months 1, 2, 3, 4, 5, and 6)
D: Eating Disorder Interview (change from baseline to one month post-intervention); Eating Disorder Inventory (Change from baseline to one month post-intervention); Eating Disorder Interview (Change from baseline to 6 mos post-intervention); Eating Disorder Interview (Change from baseline to 12 months post-intervention); Eating Disorder Inventory (Change from baseline to 6 mos post-intervention); Eating Disorder Inventory (Change from baseline to 12 mos post-intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo-Controlled, Double-Blind Trial of Asenapine in the Prevention of Relapse After Long-Term Treatment of Schizophrenia
Brief Summary: Schizophrenia is a brain disease. The condition may be associated with acute psychotic episodes and long-term disability despite remission from the acute symptoms. Current management of schizophrenia focuses on the treatment of acute symptoms as well as long-term treatment aimed at preventing relapse after patients have experienced an improvement in acute symptoms. Patients who discontinue treatment have a high likelihood of experiencing relapse within 1-2 years after an acute episode of schizophrenia. Patients who remain on antipsychotic treatment have lower rates of relapse and have milder courses of exacerbation when relapse occurs.The symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily dopamine and serotonin, which enables brain cells to communicate with each other. Asenapine may help to correct the imbalance in dopamine and serotonin. The purpose of this clinical trial is to evaluate the efficacy of asenapine in preventing relapse/impending relapse (hereafter referred to as 'relapse') in subjects who have been treated with asenapine for symptoms of schizophrenia for 26 weeks. In addition, to determine the safety and tolerability of asenapine for up to 1-year of treatment.


Options:
A: Time From Randomization to Exacerbation of Psychotic Symptoms/Impending Relapse in Phase C. (From randomization to time of exacerbation of psychotic symptoms/impending relapse - up to 52 weeks)
B: Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time (Baseline, Month 6, month 12, month 18 and month 24)
C: Time From Baseline to the First Symptom Relapse During the Double-blind Phase (Up to 34 Weeks and Bi-Weekly thereafter until Week 92)
D: Time to Relapse or an Impending Relapse (time of first relapse up to Day 182 (double blind phase))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Oral Sucrose Analgesia During Routine Immunizations at 6 Weeks and 4 Months of Age
Brief Summary: The study explores the potential benefits of a sugar water solution for decreasing pain in infants during routine immunizations.


Options:
A: - Infant pain score during the newborn screening test, assessed by the Premature Infant Pain Profile (PIPP), or individual parameters of PIPP (facial grimace, heart rate, oxygen saturation)
B: Neonatal pain scales: Neonatal infant pain Scale (NIPS), Neonatal Facial Coding System (NFCS) and Premature Infant Pain Profile (PIPP) (before the pain procedure (atrest), during cleaning of the region, at injection, and 2 minutes after injection)
C: Premature Infant Pain Profile (PIPP) scale rate (0-21) (15 seconds before and Within 30 seconds after heel lance)
D: The University of Wisconsin Children's Hospital Pain Scale will measure the primary outcome acute behavioral pain response. Measure will be recorded at baseline, immediately after immunizations and 3 minutes following immunizations

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Twelve-Week Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety and Efficacy of a Flexible-Dosing Strategy for CP-526,555 ( 0.5 mg to 2.0 mg Total Daily Dose ) in Smoking Cessation
Brief Summary: The purpose of the study was to measure the safety and efficacy of a 12-week flexible dosing strategy of CP-526,555 compared with placebo for smoking cessation. Post-treatment follow-up of smoking status to one year from randomization was performed in a non-treatment extension Protocol A3051019


Options:
A: Summarization of safety data in smokers treated with either varenicline or placebo.
B: Changes in endothelial function between baseline and during medically-aided smoking cessation program. (Baseline, 1 month, 3 months, 6 months and 12 months.)
C: 4-week continuous quit rate (CQR) at Weeks 4-7 and 9-12 .
D: Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt) (weeks 9 through 12)

Answer: C