TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Study of 2 Dose Regimens of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment-Naive Subjects With Genotype 1 Chronic Hepatitis C
Brief Summary: A Phase 3 study to evaluate the efficacy and safety of two dosing regimens of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV).


Options:
A: Percentage of Participants With Sustained Viral Response (SVR) at Week 72 (Week 72)
B: Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) (At follow-up Week 12)
C: Proportion of treated subjects with SVR12, defined as HCV RNA < LOQ at post treatment Week 12, for subjects who are prior null or partial responders to P/R or are treatment-naive (At 12 weeks post-treatment)
D: Number of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels 24 Weeks After Last Planned Dose of Study Treatment (24 weeks after last planned dose of study treatment (up to Week 72))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Study of 2 Dose Regimens of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment-Naive Subjects With Genotype 1 Chronic Hepatitis C
Brief Summary: A Phase 3 study to evaluate the efficacy and safety of two dosing regimens of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV).


Options:
A: Time to Observation of the First Clinical Event Experienced by a Subject (Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event)
B: Number of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels 24 Weeks After Last Planned Dose of Study Treatment (24 weeks after last planned dose of study treatment (up to Week 72))
C: Progression of Liver Disease as Indicated by Death, Hepatic Decompensation, Hepatocellular Carcinoma, or for Patients With Noncirrhotic Fibrosis at Baseline, an Increase in the Ishak Hepatic Fibrosis Score of 2 or More Points (1400 days (3.85 years) post randomization); Increase in Ishak Fibrosis Score by 2 Points or More at 2 or 4 Year Biopsies (1400 days (3.85 years) post randomization); Death From Any Cause (1400 days (3.85 years) post randomization); Development of Hepatocellular Carcinoma (HCC) (1400 days (3.85 years) post randomization); Child-Turcotte-Pugh (CTP) Score of 7 or Higher at Two Consecutive Study Visits (1400 days (3.85 years) post randomization); Variceal Hemorrhage (1400 days (3.85 years) post randomization); Ascites (1400 days (3.85 years) post randomization); Spontaneous Bacterial Peritonitis (1400 days (3.85 years) post randomization); Hepatic Encephalopathy (1400 days (3.85 years) post randomization)
D: Sustained Virologic Response (SVR) Rate (At Follow-up Week (FW) 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Controlled Trial of Regular Sildenafil Citrate in the Prevention of Altitude Illness
Brief Summary: The purpose of this study is to determine whether regular oral use of sildenafil citrate can prevent or attenuate high altitude illnesses.


Options:
A: Effect of study treatment on 24 h ambulatory systolic blood pressure at high altitude (After 6 weeks of study treatment, during high altitude visit)
B: acute mountain sickness (during ascent)
C: Change in Optic Nerve Sheath Diameter by Ultrasonography (Optic Nerve Sheath Diameter: baseline, 24 hours.)
D: Pulmonary Artery Systolic Pressure (PASP)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Controlled Trial of Regular Sildenafil Citrate in the Prevention of Altitude Illness
Brief Summary: The purpose of this study is to determine whether regular oral use of sildenafil citrate can prevent or attenuate high altitude illnesses.


Options:
A: Time to First Confirmed Morbidity or Mortality Event up to the End of Treatment (Kaplan-Meier Estimate of Patients Without a Morbidity or Mortality Event) (Up to end of treatment (data presented up to month 36))
B: 6 minutes walking distance
C: Pulmonary Artery Systolic Pressure (PASP)
D: Endurance time (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Parallel-Group Study of the Safety of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 6 Months to 11 Months With Symptoms of Allergic Rhinitis or Chronic Urticaria.
Brief Summary: To determine the safety of levocetirizine in children ages 6-11 months with symptoms of allergic rhinitis or chronic idiopathic urticaria.


Options:
A: Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR) (Baseline, 14 days); Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval (Baseline, 14 days); Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval (Baseline, 14 days); Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration (Baseline, 14 days); Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval (Baseline, 14 days); Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) (Baseline, 14 days); Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 3 (Day 7) (7 days); Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) (14 days)
B: Reduction in size of existing spontaneous urticaria lesions (wheal and flare) as assessed by thermography. (5 hours)
C: Change From Baseline in the Weekly Itch Severity Score at Week 12 (Baseline, Week 12)
D: Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR) (Baseline, 14 days); Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval (Baseline, 14 days); Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval (Baseline, 14 days); Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration (Baseline, 14 days); Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval (Baseline, 14 days); Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) (Baseline, 14 days); Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 3 (Day 7) (7 days); Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) (14 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Tandem Colonoscopy Study of Narrow Band Imaging Versus White Light Examination to Compare Neoplasia Miss Rates
Brief Summary: The purpose of the study is to determine if colonoscopic examination using a colonoscope with a narrow band imaging light is more effective at detecting polyps compared to a colonoscope with standard full spectrum white light.


Options:
A: Neoplasm Miss Rate (same day)
B: The primary outcome is whether the patient is a responder or not after 8 weeks treatment.; The primary efficacy outcome is based on symptom score recorded daily during the study in a patient diary.; The patient will judge their symptoms of pain or burning centered in the upper abdomen on a four-graded scale (none, mild, moderate or severe).
C: Number of patients with at least one adenoma; after white light endoscopy compared with the number of patients; with at least one adenoma after white light NBI in the right colon.
D: adenoma detection rate (number of polyps/number of patients examined) (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation in Patients With COPD (SMOCC) in General Practice
Brief Summary: Background: Smoking cessation is the key element in the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD). The role of the general practice in assisting these patients with successful quitting smoking was suboptimal. Therefore we evaluated the effectiveness of two smoking cessation programs (counseling and nicotine replacement) for smokers with COPD in routine general practice, one with (CNB) and one without (CN) the combination with bupropion-SR, compared to usual care (UC) and explored the role of COPD symptoms in successful smoking cessation.

Method: RCT with 667 patients with COPD, 68 general practices were randomly allocated. The usual care group (UC) consisted of 148 patients (22 practices), the first intervention group (counseling plus nicotine replacement (CN) of 243 patients (21 practices) and the second intervention group of 276 patients (25 practices. Main outcome measure was (biochemically verified) point prevalence.


Options:
A: Number of Participants With Smoking Abstinence at Month 6 (Month 6)
B: Proportion of Cocaine Positive Urine Tests Per Week (Weekly Measures over 12 weeks)
C: Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking (Week 15 - 24)
D: Smoking cessation (point prevalence, both self reported as biochemical verified) (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation in Patients With COPD (SMOCC) in General Practice
Brief Summary: Background: Smoking cessation is the key element in the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD). The role of the general practice in assisting these patients with successful quitting smoking was suboptimal. Therefore we evaluated the effectiveness of two smoking cessation programs (counseling and nicotine replacement) for smokers with COPD in routine general practice, one with (CNB) and one without (CN) the combination with bupropion-SR, compared to usual care (UC) and explored the role of COPD symptoms in successful smoking cessation.

Method: RCT with 667 patients with COPD, 68 general practices were randomly allocated. The usual care group (UC) consisted of 148 patients (22 practices), the first intervention group (counseling plus nicotine replacement (CN) of 243 patients (21 practices) and the second intervention group of 276 patients (25 practices. Main outcome measure was (biochemically verified) point prevalence.


Options:
A: Smoking cessation (point prevalence, both self reported as biochemical verified) (12 months)
B: COPD Assessment Test (CAT) (Baseline and 6 months)
C: Change in exercise tolerance (Up to 6 months); Change in lung microbiota (Up to 6 months)
D: Difference i patients' assessment of Clinical COPD Questionnaire (CCQ) before the intervention and 18 months later. (1-2 months before the intervention and 18 months after the intervention); Difference in questionnaire about knowledge in COPD (questionnaire created by the research group)among the general practitioners that receive the education. (Immediately before the intervention and 12 months later.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation in Patients With COPD (SMOCC) in General Practice
Brief Summary: Background: Smoking cessation is the key element in the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD). The role of the general practice in assisting these patients with successful quitting smoking was suboptimal. Therefore we evaluated the effectiveness of two smoking cessation programs (counseling and nicotine replacement) for smokers with COPD in routine general practice, one with (CNB) and one without (CN) the combination with bupropion-SR, compared to usual care (UC) and explored the role of COPD symptoms in successful smoking cessation.

Method: RCT with 667 patients with COPD, 68 general practices were randomly allocated. The usual care group (UC) consisted of 148 patients (22 practices), the first intervention group (counseling plus nicotine replacement (CN) of 243 patients (21 practices) and the second intervention group of 276 patients (25 practices. Main outcome measure was (biochemically verified) point prevalence.


Options:
A: Change in SGRQ (12 months)
B: Change from baseline at 12 month in Annual systematic chronic disease follow up consultations (Month 4, 3, 2 before baseline and month 13,14,15 after baseline (after intervention))
C: Smoking cessation (point prevalence, both self reported as biochemical verified) (12 months)
D: The primary endpoint will be change from baseline in the dyspnoea domain of the Chronic Respiratory Questionnaire (CRQ). (14 Months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation in Patients With COPD (SMOCC) in General Practice
Brief Summary: Background: Smoking cessation is the key element in the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD). The role of the general practice in assisting these patients with successful quitting smoking was suboptimal. Therefore we evaluated the effectiveness of two smoking cessation programs (counseling and nicotine replacement) for smokers with COPD in routine general practice, one with (CNB) and one without (CN) the combination with bupropion-SR, compared to usual care (UC) and explored the role of COPD symptoms in successful smoking cessation.

Method: RCT with 667 patients with COPD, 68 general practices were randomly allocated. The usual care group (UC) consisted of 148 patients (22 practices), the first intervention group (counseling plus nicotine replacement (CN) of 243 patients (21 practices) and the second intervention group of 276 patients (25 practices. Main outcome measure was (biochemically verified) point prevalence.


Options:
A: Smoking abstinence: self reported abstinence (12 or more months smoking free. (24 months after last recruitment)
B: Reduction in number of cigarettes smoked as measured by the Timeline Follow-back. (Baseline, Pre Counseling Sessions 1-5, Weeks 8, 12, 24)
C: smoking abstinence: self reported abstinence (12 or more months) (12 months)
D: Smoking cessation (point prevalence, both self reported as biochemical verified) (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation in Patients With COPD (SMOCC) in General Practice
Brief Summary: Background: Smoking cessation is the key element in the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD). The role of the general practice in assisting these patients with successful quitting smoking was suboptimal. Therefore we evaluated the effectiveness of two smoking cessation programs (counseling and nicotine replacement) for smokers with COPD in routine general practice, one with (CNB) and one without (CN) the combination with bupropion-SR, compared to usual care (UC) and explored the role of COPD symptoms in successful smoking cessation.

Method: RCT with 667 patients with COPD, 68 general practices were randomly allocated. The usual care group (UC) consisted of 148 patients (22 practices), the first intervention group (counseling plus nicotine replacement (CN) of 243 patients (21 practices) and the second intervention group of 276 patients (25 practices. Main outcome measure was (biochemically verified) point prevalence.


Options:
A: Prolonged Smoking Abstinence at End of 12 Weeks of Varenicline Treatment (12 weeks)
B: Change in sputum eosinophile-% from >1% to normal or neutrophile-% from >61% to normal, from baseline (week 0) to week 12. (Time frame for primary outcome: 0-12 weeks (total study duration 24 weeks))
C: Smoking cessation (point prevalence, both self reported as biochemical verified) (12 months)
D: Weight Gain in Treatment Completers (baseline and 12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation in Patients With COPD (SMOCC) in General Practice
Brief Summary: Background: Smoking cessation is the key element in the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD). The role of the general practice in assisting these patients with successful quitting smoking was suboptimal. Therefore we evaluated the effectiveness of two smoking cessation programs (counseling and nicotine replacement) for smokers with COPD in routine general practice, one with (CNB) and one without (CN) the combination with bupropion-SR, compared to usual care (UC) and explored the role of COPD symptoms in successful smoking cessation.

Method: RCT with 667 patients with COPD, 68 general practices were randomly allocated. The usual care group (UC) consisted of 148 patients (22 practices), the first intervention group (counseling plus nicotine replacement (CN) of 243 patients (21 practices) and the second intervention group of 276 patients (25 practices. Main outcome measure was (biochemically verified) point prevalence.


Options:
A: The Fagerstrom Test for Nicotine Dependence, expired CO level, and urine cotinine will be used to determine if bupropion SR, when used as an adjunct to antipsychotic medication, is superior to placebo for helping patients with schizophrenia improve their (Expired CO weekly, Fagerstrom baseline and end of study, Urine cotinine baseline, week 2 and week 8); Neuropsychological testing will be used to determine the effects of smoking cessation on patient's attention and memory function. (Beginning and end of study)
B: Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers. (3 months); Point Prevalence Abstinence at 3 Months. (3 months)
C: Biologically-verified 7-day Point Prevalence Smoking Abstinence (End of treatment (week 6))
D: Smoking cessation (point prevalence, both self reported as biochemical verified) (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation in Patients With COPD (SMOCC) in General Practice
Brief Summary: Background: Smoking cessation is the key element in the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD). The role of the general practice in assisting these patients with successful quitting smoking was suboptimal. Therefore we evaluated the effectiveness of two smoking cessation programs (counseling and nicotine replacement) for smokers with COPD in routine general practice, one with (CNB) and one without (CN) the combination with bupropion-SR, compared to usual care (UC) and explored the role of COPD symptoms in successful smoking cessation.

Method: RCT with 667 patients with COPD, 68 general practices were randomly allocated. The usual care group (UC) consisted of 148 patients (22 practices), the first intervention group (counseling plus nicotine replacement (CN) of 243 patients (21 practices) and the second intervention group of 276 patients (25 practices. Main outcome measure was (biochemically verified) point prevalence.


Options:
A: Point prevalence abstinence
B: Number of Subjects With Four Week Continuous Quit Rate (CQR) (Week 9 through Week 12)
C: Smoking cessation (point prevalence, both self reported as biochemical verified) (12 months)
D: "Quality of care process" (one year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation in Patients With COPD (SMOCC) in General Practice
Brief Summary: Background: Smoking cessation is the key element in the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD). The role of the general practice in assisting these patients with successful quitting smoking was suboptimal. Therefore we evaluated the effectiveness of two smoking cessation programs (counseling and nicotine replacement) for smokers with COPD in routine general practice, one with (CNB) and one without (CN) the combination with bupropion-SR, compared to usual care (UC) and explored the role of COPD symptoms in successful smoking cessation.

Method: RCT with 667 patients with COPD, 68 general practices were randomly allocated. The usual care group (UC) consisted of 148 patients (22 practices), the first intervention group (counseling plus nicotine replacement (CN) of 243 patients (21 practices) and the second intervention group of 276 patients (25 practices. Main outcome measure was (biochemically verified) point prevalence.


Options:
A: To Determine the Safety of Varenicline in PLWH Who Smoke (3 months)
B: 4 week continuous quit rate (CQR) at Weeks 9-12 and Weeks 4-7
C: Number of Participants With a Quit Attempt (6 months)
D: Smoking cessation (point prevalence, both self reported as biochemical verified) (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation in Patients With COPD (SMOCC) in General Practice
Brief Summary: Background: Smoking cessation is the key element in the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD). The role of the general practice in assisting these patients with successful quitting smoking was suboptimal. Therefore we evaluated the effectiveness of two smoking cessation programs (counseling and nicotine replacement) for smokers with COPD in routine general practice, one with (CNB) and one without (CN) the combination with bupropion-SR, compared to usual care (UC) and explored the role of COPD symptoms in successful smoking cessation.

Method: RCT with 667 patients with COPD, 68 general practices were randomly allocated. The usual care group (UC) consisted of 148 patients (22 practices), the first intervention group (counseling plus nicotine replacement (CN) of 243 patients (21 practices) and the second intervention group of 276 patients (25 practices. Main outcome measure was (biochemically verified) point prevalence.


Options:
A: Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period
B: Number of Participants Reporting Continuous Smoking Abstinence in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions. (Last 4 weeks of treatment); Mean Percentage of Heavy Drinking Days Comparing Participants in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions (First 3 weeks (pretreatment))
C: Number of Subjects With a 4 Week Continuous Quit Rate (CQR) From Smokeless Tobacco (Weeks 9 through 12)
D: Smoking cessation (point prevalence, both self reported as biochemical verified) (12 months)

Answer: D