TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Implementation and Evaluation of a Medical Reconciliation Protocol
Brief Summary: An incomplete understanding of patients' preadmission medications and failure to reconcile these with medications ordered in the hospital and at discharge are major, previously unappreciated, causes of adverse drug events (ADEs). The Joint Commission for Accreditation of Healthcare Organizations has now mandated a process for reconciling all medications at hospital admission and discharge. The best ways to implement medication reconciliation and the impact on patient outcomes are unknown. We, the researchers at at Brigham and Women's Hospital, will design and implement a medication reconciliation process with two major components: 1) information technology to integrate medication reconciliation into the current workflow at Brigham and Women's Hospital (BWH); and 2) process re-design involving physicians, nurses, and pharmacists to ensure that reconciliation takes place. We will then conduct a randomized controlled trial on the General Medical Service of BWH to evaluate the effects of this new process on reducing medication reconciliation errors with the potential to cause patient harm (potential ADEs).


Options:
A: Number of patients with at least one preventable medication error (Day 1 (medical prescription at hospital admission)); Number of patients with at least one preventable medication error (Phase 2 (maximum 105 days))
B: Improvement in proportion of quality indicators achieved, for target diseases as a most responsible or primary diagnosis, between groups. (in hospital)
C: N/A
D: The probability of developing medication errors over a certain period of time and recommendations to avoid such errors. (2 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Implementation and Evaluation of a Medical Reconciliation Protocol
Brief Summary: An incomplete understanding of patients' preadmission medications and failure to reconcile these with medications ordered in the hospital and at discharge are major, previously unappreciated, causes of adverse drug events (ADEs). The Joint Commission for Accreditation of Healthcare Organizations has now mandated a process for reconciling all medications at hospital admission and discharge. The best ways to implement medication reconciliation and the impact on patient outcomes are unknown. We, the researchers at at Brigham and Women's Hospital, will design and implement a medication reconciliation process with two major components: 1) information technology to integrate medication reconciliation into the current workflow at Brigham and Women's Hospital (BWH); and 2) process re-design involving physicians, nurses, and pharmacists to ensure that reconciliation takes place. We will then conduct a randomized controlled trial on the General Medical Service of BWH to evaluate the effects of this new process on reducing medication reconciliation errors with the potential to cause patient harm (potential ADEs).


Options:
A: Mean Severity-weighted Admission Medication History (AMH) Error Score (Attempted to obtain the day after admission)
B: N/A
C: Effects on hospital visits (1 year)
D: Number of Serious Medication Errors as Determined by Interview and Medical Chart Review (Measured at Day 30)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Triple-Dummy, Placebo-Controlled, Parallel Group, Four-Week Study Assessing the Efficacy of Fluticasone Propionate Aqueous Nasal Spray 200mcg QD Versus Montelukast 10mg QD in Adolescent and Adult Subjects With Asthma and Seasonal Allergic Rhinitis Who Are Receiving ADVAIR DISKUS® 100/50mcg BID or Placebo BID
Brief Summary: This study will last up to 6 weeks. Subjects will visit the clinic up to 5 times. Certain clinic visits will include a physical examination, medical history review, and lung function tests. All study related medications and medical examinations will be provided at no cost to the subject. The drugs used in this study are approved for the age group under study.


Options:
A: N/A
B: Mean Change From Baseline at Endpoint in Morning Peak Expiration Flow (PEF) for Intent-to-Treat Population (Baseline to Endpoint (weeks 3-4)); Mean Change From Baseline at Endpoint in Morning Peak Expiratory Flow (PEF) for Per Protocol Population (Baseline to Endpoint (weeks 3-4))
C: Trough (AM pre-dose and pre-rescue bronchodilator) FEV1 (at the end of the 6 week treatment period.)
D: Maximum Post-exercise Percent (%) Fall in FEV1 (4 weeks (Weeks 0 to 4 or Weeks 6 to 10))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Triple-Dummy, Placebo-Controlled, Parallel Group, Four-Week Study Assessing the Efficacy of Fluticasone Propionate Aqueous Nasal Spray 200mcg QD Versus Montelukast 10mg QD in Adolescent and Adult Subjects With Asthma and Seasonal Allergic Rhinitis Who Are Receiving ADVAIR DISKUS® 100/50mcg BID or Placebo BID
Brief Summary: This study will last up to 6 weeks. Subjects will visit the clinic up to 5 times. Certain clinic visits will include a physical examination, medical history review, and lung function tests. All study related medications and medical examinations will be provided at no cost to the subject. The drugs used in this study are approved for the age group under study.


Options:
A: Mean Change From Baseline at Endpoint in Morning Peak Expiration Flow (PEF) for Intent-to-Treat Population (Baseline to Endpoint (weeks 3-4)); Mean Change From Baseline at Endpoint in Morning Peak Expiratory Flow (PEF) for Per Protocol Population (Baseline to Endpoint (weeks 3-4))
B: Daily asthma symptom score
C: N/A
D: The Number of Participants With a Differential Response to the Three Step-up Therapies Based on Fixed Threshold Criteria for the Following Three Asthma Control Measures: Use of Oral Prednisone for Acute Asthma Exacerbations, Asthma Control Days and FEV1. (Measured during the last 12 weeks of each 16-week treatment period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Triple-Dummy, Placebo-Controlled, Parallel Group, Four-Week Study Assessing the Efficacy of Fluticasone Propionate Aqueous Nasal Spray 200mcg QD Versus Montelukast 10mg QD in Adolescent and Adult Subjects With Asthma and Seasonal Allergic Rhinitis Who Are Receiving ADVAIR DISKUS® 100/50mcg BID or Placebo BID
Brief Summary: This study will last up to 6 weeks. Subjects will visit the clinic up to 5 times. Certain clinic visits will include a physical examination, medical history review, and lung function tests. All study related medications and medical examinations will be provided at no cost to the subject. The drugs used in this study are approved for the age group under study.


Options:
A: N/A
B: Morning Peak Expiratory Flow
C: The Number of Participants With a Differential Response to the Three Step-up Therapies Based on Fixed Threshold Criteria for the Following Three Asthma Control Measures: Use of Oral Prednisone for Acute Asthma Exacerbations, Asthma Control Days and FEV1. (Measured during the last 12 weeks of each 16-week treatment period)
D: 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)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Triple-Dummy, Placebo-Controlled, Parallel Group, Four-Week Study Assessing the Efficacy of Fluticasone Propionate Aqueous Nasal Spray 200mcg QD Versus Montelukast 10mg QD in Adolescent and Adult Subjects With Asthma and Seasonal Allergic Rhinitis Who Are Receiving ADVAIR DISKUS® 100/50mcg BID or Placebo BID
Brief Summary: This study will last up to 6 weeks. Subjects will visit the clinic up to 5 times. Certain clinic visits will include a physical examination, medical history review, and lung function tests. All study related medications and medical examinations will be provided at no cost to the subject. The drugs used in this study are approved for the age group under study.


Options:
A: Morning Peak Expiratory Flow
B: Daily asthma symptom score
C: N/A
D: Asthma Control (8 weeks (from Week 0 to Week 8))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Tobacco Dependence: Treatment and Outcomes; Pharmacotherapies: Effectiveness in Primary Care
Brief Summary: The information gathered in this study may help to develop more effective ways to help people quit smoking and stay quit in the future.


Options:
A: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
B: 6 Month Self-reported Abstinence From Smoking (6 months)
C: Smoking Abstinence (3 months); Smoking Abstinence (6 months); Smoking Abstinence (12 months)
D: Change in lung function values in smokers without previous respiratory disease (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Tobacco Dependence: Treatment and Outcomes; Pharmacotherapies: Effectiveness in Primary Care
Brief Summary: The information gathered in this study may help to develop more effective ways to help people quit smoking and stay quit in the future.


Options:
A: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)
B: 7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed (6 months post quit date)
C: Smoking Abstinence (12 months)
D: 6 Month Self-reported Abstinence From Smoking (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Tobacco Dependence: Treatment and Outcomes; Pharmacotherapies: Effectiveness in Primary Care
Brief Summary: The information gathered in this study may help to develop more effective ways to help people quit smoking and stay quit in the future.


Options:
A: percent of patients eligible for quality measures (ABCS) (1 year)
B: smoking status (six month followup)
C: Results in Abstinence Rates (1 Year)
D: 6 Month Self-reported Abstinence From Smoking (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Tobacco Dependence: Treatment and Outcomes; Pharmacotherapies: Effectiveness in Primary Care
Brief Summary: The information gathered in this study may help to develop more effective ways to help people quit smoking and stay quit in the future.


Options:
A: 6 Month Self-reported Abstinence From Smoking (6 months)
B: The primary outcome will be measured at 5, 10, 22, and 52 weeks after the target quit date and include: CO confirmed continuous abstinence from 5-10 weeks, 5-22 weeks and 5-52 weeks. (5-10 weeks, 5-22 weeks, and 5-52 weeks post target quit date)
C: Biochemically Verified 7-day Point Prevalence Abstinence (End of Treatment (week 24))
D: 6 Month Smoking Abstinence (6 months after smoking quit date); 12 Month Smoking Abstinence (12 months after smoking quit date)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Tobacco Dependence: Treatment and Outcomes; Pharmacotherapies: Effectiveness in Primary Care
Brief Summary: The information gathered in this study may help to develop more effective ways to help people quit smoking and stay quit in the future.


Options:
A: 7-day smoking abstinence (7 days); 6-month smoking abstinence (6 months); cost-effectiveness (6 months)
B: 6 Month Self-reported Abstinence From Smoking (6 months)
C: 7-day Point Prevalence Smokeless Tobacco Abstinence Biochemically Confirmed With Urine Cotinine at the End of 12 Weeks of Treatment. (At the end of treatment (12 weeks))
D: Biologically-verified 7-day Point Prevalence Smoking Abstinence (End of treatment (week 6))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Tobacco Dependence: Treatment and Outcomes; Pharmacotherapies: Effectiveness in Primary Care
Brief Summary: The information gathered in this study may help to develop more effective ways to help people quit smoking and stay quit in the future.


Options:
A: 4-week continuous quit rate (CQR) for Weeks 9-12
B: 6 Month Self-reported Abstinence From Smoking (6 months)
C: 7 day point prevalence of cigarette abstinence (End of trial (week 10))
D: Continuous Nicotine Abstinence (8 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Tobacco Dependence: Treatment and Outcomes; Pharmacotherapies: Effectiveness in Primary Care
Brief Summary: The information gathered in this study may help to develop more effective ways to help people quit smoking and stay quit in the future.


Options:
A: 6 Month Self-reported Abstinence From Smoking (6 months)
B: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
C: Cotinine-validated 7-day point prevalence tobacco abstinence at 1 year follow-up; Cotinine-validated 7-day point prevalence tobacco abstinence at 3 month follow-up (end of treatment)
D: Smoking cessation (point prevalence, both self reported as biochemical verified) (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Posttraumatic Stress Symptoms and Behavioral Problems in Children and Adolescents After Road Traffic Accidents: a Randomized Controlled Trial
Brief Summary: The purpose of this study is to study the effectiveness of an early psychological intervention 7-10 days after a road traffic accident on posttraumatic stress and behavior of children and adolescents


Options:
A: CAPS-CA (10 days, 2 months, 6 months after intervention); CBCL (10 days, 2 months, 6 months after intervention); DIKJ (10 days, 2 months, 6 months after intervention)
B: Post Traumatic Stress Disorder- Reaction Index (RI) (Baseline and Follow-up within one month of treatment completion. For controls follow up was 4 months post baseline.)
C: Change in scores on the Oxford Measure of Psychosocial Adjustment & World Health Organization Disability Assessment Schedule, 2.0 (WHODAS 2.0) (Administered at 4 timepoints: (1) baseline; (2) within 15 days of YRI completion; (3) 6 months post-YRI; (4) 12 months post-YRI)
D: UCLA PTSD Reaction Index (Pre-treatment, post-treatment, and at 4-month follow-up); Depression Self-Rating Scale (Pre-treatment, post-treatment, and 4-month follow-up); UCLA Grief Scale (Pre-treatment, post-treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Posttraumatic Stress Symptoms and Behavioral Problems in Children and Adolescents After Road Traffic Accidents: a Randomized Controlled Trial
Brief Summary: The purpose of this study is to study the effectiveness of an early psychological intervention 7-10 days after a road traffic accident on posttraumatic stress and behavior of children and adolescents


Options:
A: CAPS-CA (10 days, 2 months, 6 months after intervention); CBCL (10 days, 2 months, 6 months after intervention); DIKJ (10 days, 2 months, 6 months after intervention)
B: Major Depressive Episode (major and sub-threshold) (0, 2, 6, 12, 18 and 24 months)
C: use of Internet site (2 months)
D: Adolescents' depressive symptoms by self-report (Measured at baseline, post-treatment, and 6-month follow-ups); Adolescents' symptoms of anxiety by self-report (Measured at baseline, post-treatment, and 6-month follow-ups); Adolescents' symptoms of depression and anxiety, including clinical levels of symptoms, as assessed by diagnostic interview (Measured at baseline and 6, 18, and 30-month follow-ups)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: School-Based Asthma Therapy: Stage 2 Effectiveness Study
Brief Summary: Asthma is the most common chronic illness of childhood, and hospitalization rates are increasing. In the US, impoverished children and children from minority ethnic and racial backgrounds suffer disproportionately from asthma. While National Heart, Lung, and Blood Institute (NHLBI) guidelines recommend daily preventive medications for all children with mild persistent to severe persistent asthma, studies indicate that many children in the US who should receive preventive medications are not receiving them. The overall goal of this project is to target an ethnically diverse population of inner-city schoolchildren with asthma and explore a school-based program to reduce asthma morbidity. We hypothesize that children receiving a comprehensive school-based intervention will experience less asthma-related morbidity compared to children receiving usual care. Our comprehensive school-based intervention consists of both administration of recommended preventive asthma medications in school (with dose adjustments according to NHLBI guidelines) and an environmental tobacco smoke (ETS) reduction program in the home for smoke-exposed children. Our secondary hypothesis is that, among the subgroup of smoke-exposed children, those who receive the school-based intervention with ETS reduction will experience less asthma morbidity than those who receive usual care.


Options:
A: Pediatric Asthma Quality of Life Questionnaire (PAQLQ) (9 months post camp); Asthma Control Questions (9 months post camp)
B: Forced Expiratory Volume in the first second (FEV1 %) predicted value (2 years)
C: Number of Symptom Free Days (Average Symptom Free Days, over 2 weeks, during peak asthma season (November-February))
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: School-Based Asthma Therapy: Stage 2 Effectiveness Study
Brief Summary: Asthma is the most common chronic illness of childhood, and hospitalization rates are increasing. In the US, impoverished children and children from minority ethnic and racial backgrounds suffer disproportionately from asthma. While National Heart, Lung, and Blood Institute (NHLBI) guidelines recommend daily preventive medications for all children with mild persistent to severe persistent asthma, studies indicate that many children in the US who should receive preventive medications are not receiving them. The overall goal of this project is to target an ethnically diverse population of inner-city schoolchildren with asthma and explore a school-based program to reduce asthma morbidity. We hypothesize that children receiving a comprehensive school-based intervention will experience less asthma-related morbidity compared to children receiving usual care. Our comprehensive school-based intervention consists of both administration of recommended preventive asthma medications in school (with dose adjustments according to NHLBI guidelines) and an environmental tobacco smoke (ETS) reduction program in the home for smoke-exposed children. Our secondary hypothesis is that, among the subgroup of smoke-exposed children, those who receive the school-based intervention with ETS reduction will experience less asthma morbidity than those who receive usual care.


Options:
A: exposure to environmental tobacco smoke (6 months)
B: Air Nicotine Levels (Measured at Baseline, 3, 6 and 12 months)
C: Number of Symptom Free Days (Average Symptom Free Days, over 2 weeks, during peak asthma season (November-February))
D: Child exposure to tobacco smoke - hair nicotine (Baseline, 6 months post-intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Roflumilast on Exacerbation Rate in Patients With COPD. The AURA Study
Brief Summary: The aim of the study is to investigate the effect of roflumilast on exacerbation rate and pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily in the morning at one dose level. The study duration will last up to 56 weeks. The study will provide further data on safety and tolerability of roflumilast.

For additional information (for US patients only) see www.COPDSTUDY.net or dial 866-788-2673 (toll free).


Options:
A: Number of CD8+ Inflammatory Cells in Bronchial Biopsy Tissue. (16 weeks); Change in Number of CD8+ Inflammatory Cells in Bronchial Biopsy Tissue (Baseline to 16 weeks)
B: Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) (Change from baseline over 24 weeks of treatment)
C: Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) (Change from baseline over 52 weeks of treatment); COPD Exacerbation Rate (Moderate or Severe) (52 weeks treatment period)
D: The frequency of patients experiencing at least one moderate or severe exacerbation during the treatment period.; Change in FEV1 from baseline during the treatment period.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Roflumilast on Exacerbation Rate in Patients With COPD. The AURA Study
Brief Summary: The aim of the study is to investigate the effect of roflumilast on exacerbation rate and pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily in the morning at one dose level. The study duration will last up to 56 weeks. The study will provide further data on safety and tolerability of roflumilast.

For additional information (for US patients only) see www.COPDSTUDY.net or dial 866-788-2673 (toll free).


Options:
A: Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) (Change from baseline over 52 weeks of treatment); COPD Exacerbation Rate (Moderate or Severe) (52 weeks treatment period)
B: Change from baseline in forced expiratory volume in 1 second (FEV1) compared to placebo
C: Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) (Change from baseline over 52 weeks of treatment); COPD Exacerbation Rate (Moderate or Severe) (52 weeks treatment period)
D: change in FEV1 from baseline during the treatment period; number of COPD exacerbations.

Answer: A