TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Early In-hospital Initiation of Pharmacotherapy for Smoking Cessation, Concomitant With Nurse-Led Support, in Patients After an Acute Coronary Syndrome (ACS)
Brief Summary: The hypothesis of this study is that combination of Varenicline treatment with nurse-led hospital support during hospitalization and after discharge will result in clinically significant higher long term abstinence rates in smokers with ACS, as compared with nurse led support and placebo, without a significant increase in the risk of adverse events.


Options:
A: Primary efficacy and Safety endpoint: (within 12 month from enrollment)
B: 7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed (6 months post quit date)
C: 6 Month Self-reported Abstinence From Smoking (6 months)
D: 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))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-blind, Placebo-controlled, Multicenter Study Comparing Ciprofloxacin DPI 32.5 mg BID (Twice a Day) Intermittently Administered for 28 Days on / 28 Days Off or 14 Days on / 14 Days Off Versus Placebo to Evaluate the Time to First Pulmonary Exacerbation and Frequency of Exacerbations in Subjects With Non-Cystic Fibrosis Bronchiectasis.
Brief Summary: The purpose of this study is to evaluate if the time to first pulmonary exacerbation of bronchiectasis or its frequency can be prolonged by inhalation of ciprofloxacin for 28 days every other 28 days or for 14 days every other 14 days over 48 weeks.


Options:
A: Time to First Exacerbation Event Within 48 Weeks (Up to Week 48)
B: 24 hour sputum clearance (24 hours / 12 weeks); Quality of Life SGRQ (12 weeks)
C: Reduction in bacterial load (1 year)
D: Time to First Exacerbation Event Within 48 Weeks - Cipro 28 vs. Pooled Placebo (Up to Week 48); Time to First Exacerbation Event Within 48 Weeks - Cipro 14 vs. Pooled Placebo (Up to Week 48)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-blind, Placebo-controlled, Multicenter Study Comparing Ciprofloxacin DPI 32.5 mg BID (Twice a Day) Intermittently Administered for 28 Days on / 28 Days Off or 14 Days on / 14 Days Off Versus Placebo to Evaluate the Time to First Pulmonary Exacerbation and Frequency of Exacerbations in Subjects With Non-Cystic Fibrosis Bronchiectasis.
Brief Summary: The purpose of this study is to evaluate if the time to first pulmonary exacerbation of bronchiectasis or its frequency can be prolonged by inhalation of ciprofloxacin for 28 days every other 28 days or for 14 days every other 14 days over 48 weeks.


Options:
A: Reduction in bacterial load (1 year)
B: The primary endpoint of this study is improvement in exercise tolerance from an incremental walk test. (8 weeks)
C: Incremental Shuttle Walk Test Chronic Respiratory Disease questionnaire (July 2011)
D: Time to First Exacerbation Event Within 48 Weeks - Cipro 28 vs. Pooled Placebo (Up to Week 48); Time to First Exacerbation Event Within 48 Weeks - Cipro 14 vs. Pooled Placebo (Up to Week 48)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-blind, Placebo-controlled, Multicenter Study Comparing Ciprofloxacin DPI 32.5 mg BID (Twice a Day) Intermittently Administered for 28 Days on / 28 Days Off or 14 Days on / 14 Days Off Versus Placebo to Evaluate the Time to First Pulmonary Exacerbation and Frequency of Exacerbations in Subjects With Non-Cystic Fibrosis Bronchiectasis.
Brief Summary: The purpose of this study is to evaluate if the time to first pulmonary exacerbation of bronchiectasis or its frequency can be prolonged by inhalation of ciprofloxacin for 28 days every other 28 days or for 14 days every other 14 days over 48 weeks.


Options:
A: Time to First Exacerbation Event Within 48 Weeks - Cipro 28 vs. Pooled Placebo (Up to Week 48); Time to First Exacerbation Event Within 48 Weeks - Cipro 14 vs. Pooled Placebo (Up to Week 48)
B: Change From Baseline in Total Bacterial Load in the Sputum at End of Treatment (Day 29). (Baseline and 29 days)
C: Reduction in bacterial load (1 year)
D: Time to First Exacerbation Event Within 48 Weeks (Up to Week 48)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-blind, Placebo-controlled, Multicenter Study Comparing Ciprofloxacin DPI 32.5 mg BID (Twice a Day) Intermittently Administered for 28 Days on / 28 Days Off or 14 Days on / 14 Days Off Versus Placebo to Evaluate the Time to First Pulmonary Exacerbation and Frequency of Exacerbations in Subjects With Non-Cystic Fibrosis Bronchiectasis.
Brief Summary: The purpose of this study is to evaluate if the time to first pulmonary exacerbation of bronchiectasis or its frequency can be prolonged by inhalation of ciprofloxacin for 28 days every other 28 days or for 14 days every other 14 days over 48 weeks.


Options:
A: Time to First Exacerbation Event Within 48 Weeks - Cipro 28 vs. Pooled Placebo (Up to Week 48); Time to First Exacerbation Event Within 48 Weeks - Cipro 14 vs. Pooled Placebo (Up to Week 48)
B: Time to first exacerbation (One Year)
C: Change From Baseline to Day 29 in Pseudomonas Aeruginosa (P. Aeruginosa) Density in Sputum (log10 CFUs) (Baseline (Visit 101/Day 1), Visit 102 (Day 8), Visit 103 (Day 29))
D: Time to first pulmonary exacerbation (from baseline) (48 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Short Message System (SMS) Monitoring Intended for the Suicidal Patients: Study of Efficiency
Brief Summary: The study wants to prove that SMS monitoring reduced the number of suicide attempts in six months according to the beginning of its implementation in the group of the patients benefiting SMS compared with the group of patients benefiting from the usual care.


Options:
A: The acceptability of the intervention to patients (within 6 months of study completion); The feasibility of intervention delivery at the ER setting (within 6 months of study completion); Patient recruitment (Baseline); The proportion of participating patients who can be reached by telephone contact at the 3-month follow-up. (3 months); The proportion of participating patients who can be reached by telephone contact at the 6-month follow-up. (6 months); The proportion of participating patients who can be traced from the hospital record at the 3-month. (3 months); The proportion of participating patients who can be traced from the hospital record at the 6-month. (6 months); The proportion of participating patients whose identity card number can be linked to the nationwide self-harm registry at the 6-month. (6 months); The proportion of participating patients whose identity card number can be linked to the nationwide self-harm registry at the 3-month. (3 months); Change in scores on a self-report suicidal behaviors assessment from baseline to 3 months (Baseline, 3 months); Change in scores on a self-report suicidal behaviors assessment from baseline to 6 months (Baseline, 6 months); Number of repeat self-harm episodes per person in 3 months after intervention based on hospital records (3 months); Number of repeat self-harm episodes per person in 3 months after intervention recorded in the nationwide self-harm registry (3 months); Number of repeat self-harm episodes per person in 6 months after intervention based on hospital records (6 months); Number of repeat self-harm episodes per person in 6 months after intervention recorded in the nationwide self-harm registry (6 months); Time to next self-harm repetition (in days) following randomization (6 months)
B: Change in the self-rating of affective reactivity (ARI-S) (Assessed at Baseline, at week 5, week 10 and week 11.); Clinical Global Impression - Improvement (CGI-I) total score of 1 or 2 (much improved, very much improved). (assessed at weeks 5, 10, and 11.)
C: Change from Baseline Adult Suicide Ideation Questionnaire score at 6 and 12 months (Baseline, 6 month and 12 month follow up)
D: Number of suicide reattempts in every group (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Short Message System (SMS) Monitoring Intended for the Suicidal Patients: Study of Efficiency
Brief Summary: The study wants to prove that SMS monitoring reduced the number of suicide attempts in six months according to the beginning of its implementation in the group of the patients benefiting SMS compared with the group of patients benefiting from the usual care.


Options:
A: Columbia Suicide Severity Rating Scale (CSSRS) Suicide Ideation (Baseline, 4 months post baseline, 12 months post baseline)
B: Clinical Global Impression (CGI) (Day 0); Suicide Intent Scale (Day 0); Montgomery-Asberg depression rating scale (Day 0)
C: Number of suicide reattempts in every group (6 months)
D: Change in Beck Scale for Suicide Ideation Score (Baseline, Week 10, Post-treatment Months 6 and 12); Change in Suicide Attempt Index (Baseline, Week 10, Post-treatment Months 6 and 12); Change in Index of Spouse Abuse Score (Baseline, Week 10, Post-treatment Months 6 and 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Short Message System (SMS) Monitoring Intended for the Suicidal Patients: Study of Efficiency
Brief Summary: The study wants to prove that SMS monitoring reduced the number of suicide attempts in six months according to the beginning of its implementation in the group of the patients benefiting SMS compared with the group of patients benefiting from the usual care.


Options:
A: Change in self-injury attentional bias as measured by a Dot Probe Paradigm (The Dot Probe Paradigm will be administered immediately preceding the mindfulness or control conditions and immediately following the mindfulness or control conditions)
B: Beck scale for suicidal ideation (six months)
C: Number of suicide reattempts in every group (6 months)
D: Non-suicidal self-harm (6 months); Suicidal ideation (6 months); suicide attempts (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Short Message System (SMS) Monitoring Intended for the Suicidal Patients: Study of Efficiency
Brief Summary: The study wants to prove that SMS monitoring reduced the number of suicide attempts in six months according to the beginning of its implementation in the group of the patients benefiting SMS compared with the group of patients benefiting from the usual care.


Options:
A: Number of suicide reattempts in every group (6 months)
B: Parasuicidal behaviour (intermittent)
C: Beck scale for suicidal ideation (six months)
D: Suicidal behaviour (2-year follow-up); Suicidal behaviour (1-year follow-up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Nasal High-flow vs Venturi Mask Oxygen Therapy on Weaning Outcome: a Multicenter, Randomized, Controlled Trial
Brief Summary: The purpose of this study is to determine whether, as compared with the Venturi mask, a nasal, high-flow oxygenation device (Optiflow) may reduce the extubation failure rate in patients needing oxygen therapy after extubation.


Options:
A: Measurement of safe apnea time (Maximum up to 6 minutes)
B: The partial pressure of carbon dioxide (pCO2) (From start to end of THRIVE(20 minutes)); The partial pressure of oxygen(PO2) (From start to end of THRIVE(20 minutes))
C: Reintubation (within 72 hours after extubation or at ICU discharge)
D: Successful First Attempt at Endotracheal Intubation (Defined by Confirmed Placement of an Endotracheal Tube in the Trachea During First Laryngoscopy Attempt) After Controlling for the Operator's Past Number of Procedures With the Equipment Used. (1 hour); Arterial Oxygen Saturation Nadir (Defined as Lowest Noninvasive Oxygenation Saturation Value Observed Between the Administration of Sedation and/or Neuromuscular Blockade and 2 Minutes After Successfully Secured Airway or Death). (1 hour)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Azithromycin in Treatment of Bronchiectasis
Brief Summary: Bronchiectasis is a chronic lung condition characterised primarily by dilatation of the airways. Only a small number of clinical studies have been conducted investigating the use of macrolides to treat non-cystic fibrosis bronchiectasis. The purpose of this study is to determine the efficacy of 12 weeks treatment with azithromycin in adult patients with non-cystic fibrosis bronchiectasis.


Options:
A: Reduction in bacterial load (1 year)
B: Time Until First Occurrence of Acute Chronic Obstructive Pulmonary Disease (COPD) Exacerbation (Measured monthly through 13 months)
C: 24 Hour Sputum Volume (Visit 3 (Baseline); Visit 6 (Week 12); Visit 8 (Week 24))
D: Does prolonged antibiotic treatment with AZM reduce the number of bacterial exacerbations in patients with bronchiectasis? (1 year); Does treatment with AZM increase lung function parameters (Δ FEV1, Δ FVC )? (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Azithromycin in Treatment of Bronchiectasis
Brief Summary: Bronchiectasis is a chronic lung condition characterised primarily by dilatation of the airways. Only a small number of clinical studies have been conducted investigating the use of macrolides to treat non-cystic fibrosis bronchiectasis. The purpose of this study is to determine the efficacy of 12 weeks treatment with azithromycin in adult patients with non-cystic fibrosis bronchiectasis.


Options:
A: Change From Baseline in Total Bacterial Load in the Sputum at End of Treatment (Day 29). (Baseline and 29 days)
B: 24 Hour Sputum Volume (Visit 3 (Baseline); Visit 6 (Week 12); Visit 8 (Week 24))
C: Does prolonged antibiotic treatment with AZM reduce the number of bacterial exacerbations in patients with bronchiectasis? (1 year); Does treatment with AZM increase lung function parameters (Δ FEV1, Δ FVC )? (1 year)
D: Time to First Exacerbation Event Within 48 Weeks (Up to Week 48)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Azithromycin in Treatment of Bronchiectasis
Brief Summary: Bronchiectasis is a chronic lung condition characterised primarily by dilatation of the airways. Only a small number of clinical studies have been conducted investigating the use of macrolides to treat non-cystic fibrosis bronchiectasis. The purpose of this study is to determine the efficacy of 12 weeks treatment with azithromycin in adult patients with non-cystic fibrosis bronchiectasis.


Options:
A: 24 Hour Sputum Volume (Visit 3 (Baseline); Visit 6 (Week 12); Visit 8 (Week 24))
B: Rate of Graded Pulmonary Exacerbations (52 weeks)
C: Bronchiectasis Exacerbation (1 year)
D: The primary endpoint of this study is improvement in exercise tolerance from an incremental walk test. (8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Azithromycin in Treatment of Bronchiectasis
Brief Summary: Bronchiectasis is a chronic lung condition characterised primarily by dilatation of the airways. Only a small number of clinical studies have been conducted investigating the use of macrolides to treat non-cystic fibrosis bronchiectasis. The purpose of this study is to determine the efficacy of 12 weeks treatment with azithromycin in adult patients with non-cystic fibrosis bronchiectasis.


Options:
A: Presence of malaria parasites on thick blood smear or Rapid Diagnostic Test (RDT) in children 1-60 months (Each site will report outcomes at 24 months; Niger will also report outcomes at 48 months); Fraction of isolates of pneumococcus exhibiting macrolide resistance by nasopharyngeal swabs in children 1-60 months (Each site will report outcomes at 24 months; Niger will also report outcomes at 36 months); Prevalence of macrolide resistance in the stool as determined by genetic determinants or phenotypic testing (Each site will report outcomes at 24 months; Niger will also report outcomes at 48 months); Fraction of conjunctival swabs yielding ocular chlamydia in children 1-60 months (24 months); Height over time in children aged 1-60 months (Each site will report outcomes at 24 months; Niger will also report outcomes at 48 months); Weight for Height over time in children aged 1-60 months (Each site will report outcomes at 24 months; Niger will also report outcomes at 48 months)
B: 24 Hour Sputum Volume (Visit 3 (Baseline); Visit 6 (Week 12); Visit 8 (Week 24))
C: Estimation of crude mortality by any reason of each study group; Estimation of attributable mortality by VAP of each study group; 7-day mortality rate of each group; 28-mortality rate of each group; Rate of progression to multiple organ failure and septic shock (and number of failing organs) of each study group; Time to progression to multiple organ failure and septic shock of each study group; Days of resolution of VAP; Days in ICU after diagnosis of VAP
D: Reduction in number of exacerbations (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Communication for Cancer Treatment: Addressing Concerns of Older Cancer Patients and Caregivers
Brief Summary: Over 60% of cancers occur in older persons, and the number of older persons with cancer is expected to grow as the population ages. Oncology clinical trials have traditionally excluded older patients with advanced cancer and chronic health conditions. In this context, where data is limited and risk from treatment is high, older patients with advanced cancer and their caregivers must understand how cancer treatment can affect quality of life in light of underlying health status. Better communication about age-related health conditions between oncologists, older patients with advanced cancer, and their caregivers may improve decision-making for cancer treatment and quality of life. A geriatric assessment (GA), a validated set of patient-centered outcomes, has been shown to identify concerns (e.g., function, cognition) important to older persons with cancer and their caregivers. In this cluster randomized clinical trial we examined whether providing a web-generated GA summary with targeted recommendations to older patients with advanced cancer, their caregivers, and their oncologists can improve communication about age-related concerns that could affect efficacy and tolerance of cancer treatment. We also determined whether the intervention improves patient-reported quality of life and patient and caregiver satisfaction.


Options:
A: Mean Patient-centered Communication in Advanced Cancer Score (3 years)
B: Direct Communication About Age-related Concerns: Number of Discussions Related to the Geriatric Assessment That Occur in the Clinic Visit Between the Patient, Oncology Physician, and Caregiver. [Patient-Centered Outcomes Research Institute Specified] (Baseline); Patient Satisfaction With Communication About Age-related Concerns: Measured by Health Care Climate Questionnaire (HCCQ). [NCI Specified] (Within 1-7 days of the baseline audio-recorded clinic consultation)
C: Enhanced goal-consistent care (up to 2 years); PEACE (up to 2 years)
D: Caregiver Perceptions of Pain Medicine Questionaire (Every 14 days until the death of the patient for an average of 45 days-Only measure used in analysis is the last completed measure)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Twice-Weekly Intense Aerobic Exercise in Early Subacute Stroke: A Randomized Controlled Trial.
Brief Summary: The purpose of this study was to investigate the effects of early intensive aerobic exercise regarding aerobic capacity, gait and balance, Health Related Quality of Life and participation.


Options:
A: Percentage of Patients Who Successfully Improved Functional Level of Walking at 1 Year Post-stroke (12 months post-stroke); Walking Speed: Measured During a 10-meter Walk (Baseline and 12 months post-stroke)
B: Aerobic capacity (Baseline,3month)
C: Wolf Motor Function Test (WMFT) Log-transformed Time (Baseline to 1 year post-randomization); Wolf Motor Function Test Time (Baseline to 1 year post-randomization); Stroke Impact Scale (SIS) Hand Function Subscale Score. (Baseline to 1 year post-randomization); Stroke Impact Scale (SIS), Hand Function Subscale, Percentage of Participants That Improved at Least 25 Points From Baseline to End-of-study (One Year Post-randomization) (Baseline to 1 year post-randomization)
D: Change from baseline in mobility at 2 and 4 months (before the intervention, month 2 and month 4); Change from baseline in Balance at 2 and 4 months (before the intervention, month 2 and month 4)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Twice-Weekly Intense Aerobic Exercise in Early Subacute Stroke: A Randomized Controlled Trial.
Brief Summary: The purpose of this study was to investigate the effects of early intensive aerobic exercise regarding aerobic capacity, gait and balance, Health Related Quality of Life and participation.


Options:
A: Change from baseline in Cognitive Function at 3 months (Baseline, Month 3); Change from baseline in Functional Performance at 3 months (Baseline, Month 3); Change from baseline in Muscle Function at 3 months (Baseline, Month 3)
B: Aerobic capacity (Baseline,3month)
C: modified Rankin Score (3 months)
D: Steps Per Day (Change from Baseline to 3 months (Post)); Steps Per Day (Change from 3 months (Post) to 6 months); Steps Per Day (Change from 3 months (Post) to 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label Safety and Efficacy Study for Patients With Nonsense Mutation Cystic Fibrosis Previously Treated With Ataluren (PTC124)
Brief Summary: The primary objective of this study is to determine the long-term safety and tolerability of ataluren in participants with nonsense mutation cystic fibrosis (nmCF) who completed participation in the double-blind study PTC124-GD-009-CF (NCT00803205), as assessed by adverse events and laboratory abnormalities. The secondary objective of this study includes the assessment of the efficacy of ataluren, as measured by forced expiratory volume in 1 second (FEV1) and pulmonary exacerbation rate, and other safety parameters (for example, 12-lead electrocardiogram \[ECG\] measurements, vital signs).


Options:
A: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (Baseline (Day 1) up to end of study (Week 196)); Number of Participants With Clinically Significant Laboratory Abnormalities (Baseline (Day 1) up to end of study (Week 196))
B: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 24 (Baseline, Week 16 and 24)
C: Relative (Percent) Change From Baseline in Maximal Oxygen Consumption (VO2max) During Cardiopulmonary Exercise Testing (CPET) at Week 24 (Baseline, Week 24)
D: Safety and Tolerability (Over 7 treatment days and 7 days of follow-up)

Answer: A