TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Single Center, Prospective, Randomized, Partly-Double Blinded, Controlled Trial to Assess the Safety and Feasibility of Intracoronary Cell Infusion Mobilized With G-CSF and Darbepoetin and Their Effects on Improvement of Cardiac Function in Patients With Myocardial Infarction: Myocardial Regeneration and Angiogenesis in Myocardial Infarction With G-CSF and Erythropoietin Mobilization and Intra-Coronary Cell Infusion -5-Combination Cytokine Therapy Trial
Brief Summary: Combination use of darbepoetin and G-CSF will improve left ventricular systolic function in patients with acute myocardial infarction who receive intracoronary infusion of mobilized peripheral blood stem cell in comparison with patient who treated with conventional measures and who received intracoronary infusion of mobilized peripheral blood stem cell by G-CSF alone.


Options:
A: increase in global LV ejection fraction fraction; evaluation by magnetic resonance (MRI) after 4 months
B: Global Left Ventricular Function (Measured at Baseline and Month 6); Regional Left Ventricular Function (Infarct Zone Wall Motion) (Measured at Baseline and Month 6); Regional Left Ventricular Function (Border Zone Wall Motion) (Measured at Baseline and Month 6)
C: change of left ventricular ejection fraction measured by cardiac MRI (6, 12, and 24month)
D: Global Left Ventricular Ejection Fraction change (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Single Center, Prospective, Randomized, Partly-Double Blinded, Controlled Trial to Assess the Safety and Feasibility of Intracoronary Cell Infusion Mobilized With G-CSF and Darbepoetin and Their Effects on Improvement of Cardiac Function in Patients With Myocardial Infarction: Myocardial Regeneration and Angiogenesis in Myocardial Infarction With G-CSF and Erythropoietin Mobilization and Intra-Coronary Cell Infusion -5-Combination Cytokine Therapy Trial
Brief Summary: Combination use of darbepoetin and G-CSF will improve left ventricular systolic function in patients with acute myocardial infarction who receive intracoronary infusion of mobilized peripheral blood stem cell in comparison with patient who treated with conventional measures and who received intracoronary infusion of mobilized peripheral blood stem cell by G-CSF alone.


Options:
A: Neurological/functional outcome as measured by the Barthel Index (BI) (day 90)
B: Left ventricular ejection fraction measured by magnetic resonance imaging (4-6 months)
C: change of left ventricular ejection fraction measured by cardiac MRI (6, 12, and 24month)
D: Glasgow Outcome Scale (at 6 months after injury)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An International, Open, Randomized, Controlled Study to Evaluate the Efficacy of Combining Prophylactic Curosurf® With Early Nasal CPAP Versus Early Nasal CPAP Alone in Very Preterm Infants at Risk of Respiratory Distress Syndrome
Brief Summary: The primary objective of this study is to compare two methods of post-delivery stabilization and subsequent early respiratory care for reducing the need for MV and related secondary complications, such as BPD, in premature babies at high risk of RDS:

1. Early stabilization on nCPAP
2. Intubation, prophylactic surfactant (Curosurf®) administration shortly after delivery, and rapid extubation to nCPAP.

The data obtained from this comparison will be applied to test the hypothesis that preterm neonates at risk of RDS who are treated with prophylactic surfactant + nCPAP show less need for MV when compared to infants who receive nCPAP alone.


Options:
A: Need for mechanical ventilation
B: Survival Without Bronchopulmonary Dysplasia (BPD) (36 weeks); Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery) (55 weeks)
C: Need for MV (Within the first 5 days of life)
D: Death or Chronic Lung Disease (at 36 weeks postmenstrual age); Death (36 weeks adjusted age)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An International, Open, Randomized, Controlled Study to Evaluate the Efficacy of Combining Prophylactic Curosurf® With Early Nasal CPAP Versus Early Nasal CPAP Alone in Very Preterm Infants at Risk of Respiratory Distress Syndrome
Brief Summary: The primary objective of this study is to compare two methods of post-delivery stabilization and subsequent early respiratory care for reducing the need for MV and related secondary complications, such as BPD, in premature babies at high risk of RDS:

1. Early stabilization on nCPAP
2. Intubation, prophylactic surfactant (Curosurf®) administration shortly after delivery, and rapid extubation to nCPAP.

The data obtained from this comparison will be applied to test the hypothesis that preterm neonates at risk of RDS who are treated with prophylactic surfactant + nCPAP show less need for MV when compared to infants who receive nCPAP alone.


Options:
A: Survival Without Bronchopulmonary Dysplasia (BPD) (36 weeks); Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery) (55 weeks)
B: Need for mechanical ventilation
C: Need for MV (Within the first 5 days of life)
D: Need for mechanical ventilation (Death or discharge from the NICU)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An International, Open, Randomized, Controlled Study to Evaluate the Efficacy of Combining Prophylactic Curosurf® With Early Nasal CPAP Versus Early Nasal CPAP Alone in Very Preterm Infants at Risk of Respiratory Distress Syndrome
Brief Summary: The primary objective of this study is to compare two methods of post-delivery stabilization and subsequent early respiratory care for reducing the need for MV and related secondary complications, such as BPD, in premature babies at high risk of RDS:

1. Early stabilization on nCPAP
2. Intubation, prophylactic surfactant (Curosurf®) administration shortly after delivery, and rapid extubation to nCPAP.

The data obtained from this comparison will be applied to test the hypothesis that preterm neonates at risk of RDS who are treated with prophylactic surfactant + nCPAP show less need for MV when compared to infants who receive nCPAP alone.


Options:
A: Need for mechanical ventilation (Death or discharge from the NICU)
B: Need for MV (Within the first 5 days of life)
C: Need for mechanical ventilation
D: Death or Chronic Lung Disease (at 36 weeks postmenstrual age); Death (36 weeks adjusted age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An International, Open, Randomized, Controlled Study to Evaluate the Efficacy of Combining Prophylactic Curosurf® With Early Nasal CPAP Versus Early Nasal CPAP Alone in Very Preterm Infants at Risk of Respiratory Distress Syndrome
Brief Summary: The primary objective of this study is to compare two methods of post-delivery stabilization and subsequent early respiratory care for reducing the need for MV and related secondary complications, such as BPD, in premature babies at high risk of RDS:

1. Early stabilization on nCPAP
2. Intubation, prophylactic surfactant (Curosurf®) administration shortly after delivery, and rapid extubation to nCPAP.

The data obtained from this comparison will be applied to test the hypothesis that preterm neonates at risk of RDS who are treated with prophylactic surfactant + nCPAP show less need for MV when compared to infants who receive nCPAP alone.


Options:
A: Need for MV (Within the first 5 days of life)
B: Need for mechanical ventilation (Death or discharge from the NICU)
C: Survival Without Bronchopulmonary Dysplasia (BPD) (36 weeks); Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery) (55 weeks)
D: Death or Chronic Lung Disease (at 36 weeks postmenstrual age); Death (36 weeks adjusted age)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Coccinia Cordifolia Extract in Improving Blood Glucose Levels of Newly Diagnosed Diabetic Patients
Brief Summary: The purpose of the study was to evaluate the effectiveness of Coccinia Cordifolia (synonym Coccinia indica) on the blood glucose levels of newly detected type 2 diabetic patients requiring only behavioral or lifestyle intervention. The hypothesis of the study is that there will be significant decrease in the blood glucose levels after a period of 90 days in the diabetic patients who consumed the coccinia extract.


Options:
A: - Primary outcomes include HbA1c, glucose, total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides levels. (3 months)
B: Fasting and Post Prandial Blood Glucose, Glycosylated Hemoglobin (90 days)
C: hemoglobin A1c
D: Relative risk of major maternal hypoglycaemia (after 24 hours)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Adjuvant Low-dose Interleukin-2 (IL2) Plus Interferone-alpha (IFN) in Operable Renal Cell Cancer (RCC). Phase III, Randomized, Multicenter Trial of the Italian Oncology Group for Clinical Research (GOIRC).
Brief Summary: The aim of this study is to compare the efficacy (in terms of event-free survival and overall survival) of an adjuvant therapy with IFN-alpha plus low-dose of IL2 vs a wait-and-see program in patient with radically operated renal cell carcinoma.


Options:
A: Overall Survival (OS) (Baseline up to Month 80)
B: Progression Free Survival (PFS) (From randomization to disease progression or death (up to approximately 2 years))
C: Progression Free Survival (2 3/4 years)
D: Recurrence-free survival: loco-regional, adrenal, kidney and distant-metastases were the events considered for event-free survival.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 4 Comparative Study of Pegasys vs Peg-Intron for Treatment of Chronic Hepatitis C Genotype 4
Brief Summary: Genotype 4 hepatitis C virus is the cause of approximately 20% of the 170 million cases of chronic hepatitis C in the world. Although rare in western nations, genotype 4 is the most common variant of the hepatitis C virus in Egypt and is also found throughout Africa and the Middle East. Early reports on the treatment of patients with genotype 4 chronic hepatitis C with interferon-alfa (IFN)-alfa monotherapy indicate poor rates of sustained viral response (SVR). With the introduction of ribavirin combination therapy and with pegylation of the IFN alfa molecule, however, response rates have improved dramatically, and current clinical trial data indicate that SVR rates between 43 and 79% are attainable in genotype 4 patients who are receiving pegylated IFN alfa plus ribavirin for 48 weeks. Clinical advances to optimize treatment for each patient have also been made, and tailored treatment options are now being developed that are comparable to the treatment approaches for genotype 1, 2, and 3 patients. A treatment duration of between 36 and 48 weeks appears to be optimal for most patients with chronic hepatitis C genotype 4.The aim of this study is to assess the efficacy and safety of pegylated interferon alpha 2a in patients with chronic hepatitis C genotype 4 in comparison to a historical cohort of patients treated with pegylated interferon alpha 2b


Options:
A: SVR, defined as undetectable serum HCV RNA (24 weeks after discontinuation of treatment)
B: Sustained Virologic Response (SVR) Rate (Assessed at the end of a 24-week post-treatment follow-up)
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: Change From Baseline in Viral Load (log10 Reduction) at Week 12 (From Baseline to Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Naltrexone and Varenicline: Weight Gain and Tolerability in Smokers
Brief Summary: The purpose of this study is to determine whether the combination of naltrexone (Depade) and varenicline (Chantix) minimizes post-smoking cessation weight gain and how well the combination is tolerated.


Options:
A: Emotional Reactivity By Pharmacotherapy (Baseline to 1 month); Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele (Baseline to 1 month)
B: Continuous smoking abstinence rate (Weeks 9 to 12)
C: Comparison of Prolonged Abstinence (up to12 weeks post-quit)
D: Weight Gain in Treatment Completers (baseline and 12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Naltrexone and Varenicline: Weight Gain and Tolerability in Smokers
Brief Summary: The purpose of this study is to determine whether the combination of naltrexone (Depade) and varenicline (Chantix) minimizes post-smoking cessation weight gain and how well the combination is tolerated.


Options:
A: Weight Gain in Treatment Completers (baseline and 12 weeks)
B: Comparison of Prolonged Abstinence (up to12 weeks post-quit)
C: Self- Reported 7-day Abstinence (6 Months); Carbon Monoxide (CO)-Confirmed 7-day Abstinence (6-Months); Rates of Smoking Cessation Continuous From First Quit Day to 6 Months (6-Months); Self-reported 7-day Abstinence (12 Months); CO-confirmed 7-day Abstinence (12 Months)
D: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Naltrexone and Varenicline: Weight Gain and Tolerability in Smokers
Brief Summary: The purpose of this study is to determine whether the combination of naltrexone (Depade) and varenicline (Chantix) minimizes post-smoking cessation weight gain and how well the combination is tolerated.


Options:
A: Seven-day point prevalence and treatment or treatment strategy (At week 6); Main effects of varenicline and nicotine patch + lozenge on smokers who remain on these medications throughout the trial as documented in questionnaires (Up to 12 weeks); Probability of response at week 12 conditional on response at week 6 and continuation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and continuation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and augmentation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and treatment switching (At 12 weeks); Probability that treatment continuation, switching, or augmentation confers benefit conditional upon failing to quit after the initial treatment with nicotine patch + lozenge for six weeks (12 weeks); Probability that treatment continuation, switching, or augmentation confers benefit conditional upon failing to quit after initial treatment with varenicline for six weeks (12 weeks)
B: Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 12 (12 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 24 (24 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 52 (52 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 64 (64 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 104 (104 weeks following treatment initiation)
C: Weight Gain in Treatment Completers (baseline and 12 weeks)
D: Self- Reported 7-day Abstinence (6 Months); Carbon Monoxide (CO)-Confirmed 7-day Abstinence (6-Months); Rates of Smoking Cessation Continuous From First Quit Day to 6 Months (6-Months); Self-reported 7-day Abstinence (12 Months); CO-confirmed 7-day Abstinence (12 Months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Naltrexone and Varenicline: Weight Gain and Tolerability in Smokers
Brief Summary: The purpose of this study is to determine whether the combination of naltrexone (Depade) and varenicline (Chantix) minimizes post-smoking cessation weight gain and how well the combination is tolerated.


Options:
A: N/A
B: Rating of urges to smoke 1-week after the target quit (1 week)
C: The primary outcome will be the biochemically confirmed (exhaled CO < 10 ppm) self-reported continuous abstinence for weeks 12 to 26. (26 weeks)
D: Weight Gain in Treatment Completers (baseline and 12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Naltrexone and Varenicline: Weight Gain and Tolerability in Smokers
Brief Summary: The purpose of this study is to determine whether the combination of naltrexone (Depade) and varenicline (Chantix) minimizes post-smoking cessation weight gain and how well the combination is tolerated.


Options:
A: Emotional Reactivity By Pharmacotherapy (Baseline to 1 month); Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele (Baseline to 1 month)
B: tobacco abstinence (6 months)
C: Weight Gain in Treatment Completers (baseline and 12 weeks)
D: Smoking status at 6 months after enrollment (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Naltrexone and Varenicline: Weight Gain and Tolerability in Smokers
Brief Summary: The purpose of this study is to determine whether the combination of naltrexone (Depade) and varenicline (Chantix) minimizes post-smoking cessation weight gain and how well the combination is tolerated.


Options:
A: Weight Gain in Treatment Completers (baseline and 12 weeks)
B: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
C: Percentage of Participants With a Four-Week Continuous Quit Rate (CQR) (Week 9 through Week 12)
D: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Naltrexone and Varenicline: Weight Gain and Tolerability in Smokers
Brief Summary: The purpose of this study is to determine whether the combination of naltrexone (Depade) and varenicline (Chantix) minimizes post-smoking cessation weight gain and how well the combination is tolerated.


Options:
A: Prevention in relapse (Up to 6 months)
B: Weight Gain in Treatment Completers (baseline and 12 weeks)
C: Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking (Week 15 - 24)
D: Proportion of Cocaine Positive Urine Tests Per Week (Weekly Measures over 12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Naltrexone and Varenicline: Weight Gain and Tolerability in Smokers
Brief Summary: The purpose of this study is to determine whether the combination of naltrexone (Depade) and varenicline (Chantix) minimizes post-smoking cessation weight gain and how well the combination is tolerated.


Options:
A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Baseline up to 30 days after last dose of study treatment or up to Week 16); Number of Participants With Psychiatric Adverse Events (Baseline up to Week 24); Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Total Score (Baseline to Week 12); Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Total Score (Baseline to Week 24); Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score (Baseline to Week 12); Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score (Baseline to Week 24); Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score (Baseline to Week 12); Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score (Baseline to Week 24); Change From Baseline to Week 12 in Simpson Angus Rating Scale (SARS) (Baseline to Week 12); Change From Baseline to Week 24 in Simpson Angus Rating Scale (SARS) (Baseline to Week 24); Number of Participants With Suicidal Behavior and / or Ideation ("Yes" Response) on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Treatment Phase (Week 1 to Week 12 (Treatment phase)); Number of Participants With Suicidal Behavior or Suicical Ideation ("Yes" Response ) on the Columbia Suicide-Severity Rating Scale (C-SSRS) During the Post Treatment Phase (Week 13 to Week 24 (Post treatment phase)); Number of Participants With Shift From Baseline to Week 12 in Clinical Global Impressions Scale-Severity (CGI-S) Score (Baseline (Bsl) to Week 12); Number of Participants With Shift From Baseline to Week 24 in Clinical Global Impressions Scale-Severity (CGI-S) Score (Baseline to Week 24); Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 1 (Baseline, Week 1); Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 12 (Baseline, Week 12); Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 24 (Baseline, Week 24)
B: Weight Gain in Treatment Completers (baseline and 12 weeks)
C: Determine the efficacy of combined therapy (VRN+nicotine patches) versus monotherapy (VRN+placebo patches) in smoking cessation assessed as continuous abstinence rate (CAR) from week 2 to week 12. (Participants will be followed for the duration of treatment, 12 weeks.)
D: The primary outcome variable for the study was biochemically verified 7-day point prevalence smoking cessation at 6 months, defined as having smoked no cigarettes - not even a puff - for the previous 7 days. (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Telemonitoring in Patients With Heart Failure
Brief Summary: The purpose of this study is to investigate if telemonitoring results in a decrease in hospital admissions, with equal quality of care defined as mortality, quality of life and unplanned visits with caregivers. Telemonitoring is expected to be more cost-effective than usual care in patients with heart failure.


Options:
A: To what extent does the use of Health Buddy result in a decrease in hospital admissions? (one year); To what extent is Health Buddy® more cost-effective than usual care? (one year); To what extent will the amount of planned contacts decrease without an increase of unplanned contacts? (one year)
B: Changes of glycosilated haemoglobin (HbA1c) (At least 12 weeks from baseline (visit 3))
C: Change in medication adherence (Baseline, 6 months, 9 months, 12 months, 15 months, and 18 months); Change in number of hospitalizations (costs) (Baseline, 6 months, 9 months, 12 months, 15 months, and 18 months)
D: Percentage of Participants With First Diagnosis of Clinically Actionable Events (CAE) at 12 Months (One year post-enrollment)

Answer: A