TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Clinical Trial of S-1 Plus Cisplatin Versus 5-FU Plus Cisplatin in Patients With Unresectable or Advanced Gastric Cancer
Brief Summary: The purpose of this study is to evaluate the effectiveness and safety of s-1 plus cisplatin versus 5-FU plus cisplatin as first-line therapy in the treatment of patients with advanced gastric cancer.


Options:
A: Time to progression (The time from randomization until objective tumor progression or death)
B: Recurrence of the original cancer (From the beginning to end of the study); Development of a new gastric cancer (From beginning to end of study); Death due to any cause (From the beginning to the end of study); Adverse events (From beginning to end of study); Clinical laboratory tests (From beginning to end of study)
C: Progression free survival (8 weeks)
D: Percentage of Participants With PD or Death as Assessed by an Independent Review Committee (IRC) (From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)); Progression-free Survival (PFS) as Assessed by an IRC (Co-primary Endpoint) (From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)); Percentage of Participants Who Died: Second Interim Analysis (From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months)); Overall Survival: Second Interim Analysis (Co-primary Endpoint) (From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months)); Percentage of Participants Who Died: Final Analysis (From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months)); Overall Survival: Final Analysis (From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months)); Percentage of Participants Who Were Alive at Year 1 (Year 1); Percentage of Participants Who Were Alive at Year 2 (Year 2)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Clinical Trial of S-1 Plus Cisplatin Versus 5-FU Plus Cisplatin in Patients With Unresectable or Advanced Gastric Cancer
Brief Summary: The purpose of this study is to evaluate the effectiveness and safety of s-1 plus cisplatin versus 5-FU plus cisplatin as first-line therapy in the treatment of patients with advanced gastric cancer.


Options:
A: Progression-free survival (PFS) in all patients (Up to 18 months); Progression-free survival (PFS) in patients with Met-positive tumors (Up to 18 months)
B: Overall Survival (OS) (From the date of randomization until disease progression or death, cut-off date: 15 August 2014 (approximately 40 months))
C: Time to progression (The time from randomization until objective tumor progression or death)
D: Time to Progression (every 8 weeks up to a maximum of 36 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase IV Study for Effect of Intensive Blood-Pressure Control Using Anti-hypertensive Agents in Essential Hypertension With History of Stroke
Brief Summary: 1. Objectives and Hypothesis

   1. Objectives:

      This study evaluates whether strict BP management is useful for the prevention of recurrent stroke.

      Hypertensive patients with history of stroke are treated with stepwise multi-drug therapy to achieve stricter BP target \<120/80 mmHg in the strict BP control group and less stricter BP target \<140/90 mmHg or \<130/80 mmHg for patients with current DM/CKD/MI in the standard BP control group. The participants under the BP treatment achieving their respective BP target will be followed for recurrence of stroke. The study continues until the number of patients with the first recurrent stroke reaches a total of 330 between the two groups. The occurrence rates of recurrent stroke will be compared between the two groups.
   2. Hypotheses The incidence of recurrent stroke will be lower in a strict BP control group having lower BP target: \<120/80 mmHg\* than in a standard BP control group having BP target \<140/90 mmHg or \<130/80 mmHg for current DM/CKD/MI in patients with hypertension.
2. Study design This will be a multicenter, randomized, open-label study. The study consists of a screening period, a titration period and a follow-up period. The screening period is a period between the date of consent and the enrollment date. Hypertensive patients with history of stroke are randomly assigned to either the strict BP control group having the target of \<120/80 mmHg or the standard BP control group having the target of \<140/90 mmHg without current DM, CKD or MI and \<130/80 mmHg with current DM, CKD or MI. The titration period is the period finding a treatment which achieves target BP, and 24 weeks at maximum. Patients will be treated with stepwise multi-drug therapy using an angiotensin-receptor antagonist, diuretic, calcium channel blocker and aldosterone antagonist. The participants will be observed under the BP management for their respective BP target. The study will be continued until the number of patients with the first recurrent stroke reaches a total of 330 between two groups. The follow-up period will be 3 years.

The recurrent rates of stroke in both groups will be compared from various aspects, and strict BP management will be investigated on the usefulness in prevention of recurrent stroke.


Options:
A: the prevention of recurrent stroke. (Until the first recurrent stroke reaches a total of 339 between the two groups)
B: First occurrence of death or nonfatal myocardial infarction (MI) or nonfatal stroke
C: Recurrent stroke (five years)
D: First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. (4.9 years); First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. (4.7 years); First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. (4.7 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase IV Study for Effect of Intensive Blood-Pressure Control Using Anti-hypertensive Agents in Essential Hypertension With History of Stroke
Brief Summary: 1. Objectives and Hypothesis

   1. Objectives:

      This study evaluates whether strict BP management is useful for the prevention of recurrent stroke.

      Hypertensive patients with history of stroke are treated with stepwise multi-drug therapy to achieve stricter BP target \<120/80 mmHg in the strict BP control group and less stricter BP target \<140/90 mmHg or \<130/80 mmHg for patients with current DM/CKD/MI in the standard BP control group. The participants under the BP treatment achieving their respective BP target will be followed for recurrence of stroke. The study continues until the number of patients with the first recurrent stroke reaches a total of 330 between the two groups. The occurrence rates of recurrent stroke will be compared between the two groups.
   2. Hypotheses The incidence of recurrent stroke will be lower in a strict BP control group having lower BP target: \<120/80 mmHg\* than in a standard BP control group having BP target \<140/90 mmHg or \<130/80 mmHg for current DM/CKD/MI in patients with hypertension.
2. Study design This will be a multicenter, randomized, open-label study. The study consists of a screening period, a titration period and a follow-up period. The screening period is a period between the date of consent and the enrollment date. Hypertensive patients with history of stroke are randomly assigned to either the strict BP control group having the target of \<120/80 mmHg or the standard BP control group having the target of \<140/90 mmHg without current DM, CKD or MI and \<130/80 mmHg with current DM, CKD or MI. The titration period is the period finding a treatment which achieves target BP, and 24 weeks at maximum. Patients will be treated with stepwise multi-drug therapy using an angiotensin-receptor antagonist, diuretic, calcium channel blocker and aldosterone antagonist. The participants will be observed under the BP management for their respective BP target. The study will be continued until the number of patients with the first recurrent stroke reaches a total of 330 between two groups. The follow-up period will be 3 years.

The recurrent rates of stroke in both groups will be compared from various aspects, and strict BP management will be investigated on the usefulness in prevention of recurrent stroke.


Options:
A: Recurrent stroke (five years)
B: the prevention of recurrent stroke. (Until the first recurrent stroke reaches a total of 339 between the two groups)
C: Major cardiovascular events (5 years)
D: Stroke event (Up to four years of follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase IV Study for Effect of Intensive Blood-Pressure Control Using Anti-hypertensive Agents in Essential Hypertension With History of Stroke
Brief Summary: 1. Objectives and Hypothesis

   1. Objectives:

      This study evaluates whether strict BP management is useful for the prevention of recurrent stroke.

      Hypertensive patients with history of stroke are treated with stepwise multi-drug therapy to achieve stricter BP target \<120/80 mmHg in the strict BP control group and less stricter BP target \<140/90 mmHg or \<130/80 mmHg for patients with current DM/CKD/MI in the standard BP control group. The participants under the BP treatment achieving their respective BP target will be followed for recurrence of stroke. The study continues until the number of patients with the first recurrent stroke reaches a total of 330 between the two groups. The occurrence rates of recurrent stroke will be compared between the two groups.
   2. Hypotheses The incidence of recurrent stroke will be lower in a strict BP control group having lower BP target: \<120/80 mmHg\* than in a standard BP control group having BP target \<140/90 mmHg or \<130/80 mmHg for current DM/CKD/MI in patients with hypertension.
2. Study design This will be a multicenter, randomized, open-label study. The study consists of a screening period, a titration period and a follow-up period. The screening period is a period between the date of consent and the enrollment date. Hypertensive patients with history of stroke are randomly assigned to either the strict BP control group having the target of \<120/80 mmHg or the standard BP control group having the target of \<140/90 mmHg without current DM, CKD or MI and \<130/80 mmHg with current DM, CKD or MI. The titration period is the period finding a treatment which achieves target BP, and 24 weeks at maximum. Patients will be treated with stepwise multi-drug therapy using an angiotensin-receptor antagonist, diuretic, calcium channel blocker and aldosterone antagonist. The participants will be observed under the BP management for their respective BP target. The study will be continued until the number of patients with the first recurrent stroke reaches a total of 330 between two groups. The follow-up period will be 3 years.

The recurrent rates of stroke in both groups will be compared from various aspects, and strict BP management will be investigated on the usefulness in prevention of recurrent stroke.


Options:
A: First occurrence of death or nonfatal myocardial infarction (MI) or nonfatal stroke
B: Number of Participants With First Occurrence of a Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Stroke, Heart Failure (HF), or CVD Death (6 years)
C: Ischemic Lesion Volume Change in the Whole Forebrain on Fluid Attenuation Inversion Recovery (FLAIR) Magnetic Resonance Imaging (MRI) (Screening to 24 weeks)
D: the prevention of recurrent stroke. (Until the first recurrent stroke reaches a total of 339 between the two groups)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity, Reactogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Taiwanese Infants Who Received Hepatitis B Immunoglobulin After Birth.
Brief Summary: The purpose of this study is to assess immunogenicity and safety of Rotarix TM when administered in healthy Taiwanese infants (aged 6 to 12 weeks at the time of first vaccination) who received Hepatitis B immunoglobulin after birth.


Options:
A: Number of Participants With Vaccine Induced Reactions (7 days following each dose); Number of Participants With Serious Adverse Events (within 28 days of a study dose and at any time); Number of Participants Reporting Any Non-Serious Adverse Event (6 mo following first vaccination); Number/Percentage of Infant Participants With Anti-P2-VP8 IgA to P[8] Seroresponse. (Baseline to day 84); Number/Percentage of Infants With Anti-P2-VP8 IgG to P[8] Seroresponses (Baseline to day 84); Number/Percentage of Infants With Neutralizing Antibody Response to WA Strain (G1[P8]) (Baseline to Day 84)
B: occurrence of Severe Rotavirus Gastroenteritis (Up to 2 years of age of participants)
C: Demonstrate that coadministration with HRV vaccine does not impair the immune response to all antigens contained in each of the routine infant vaccines.
D: Number of Seroconverted Subjects for Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody. (2 months post-Dose 2 (at study Month 4))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity, Reactogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Taiwanese Infants Who Received Hepatitis B Immunoglobulin After Birth.
Brief Summary: The purpose of this study is to assess immunogenicity and safety of Rotarix TM when administered in healthy Taiwanese infants (aged 6 to 12 weeks at the time of first vaccination) who received Hepatitis B immunoglobulin after birth.


Options:
A: Number of Seroconverted Subjects for Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody. (2 months post-Dose 2 (at study Month 4))
B: Occurrence of Severe Clinical Rotavirus Disease Caused by Any Rotavirus Serotype More Than 14 Days Following the Third Dose (At least 14 days following the third vaccination)
C: Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the WC3 IgA Assay (3-6 weeks after the last vaccination); Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the 89-12 IgA Assay (3-6 weeks after the last vaccination); Geometric Mean Serum Anti-rotavirus IgA Titer (3-6 weeks after the last dose of vaccine)
D: Endpoints : Safety/immunogenicity.Immunogenicity of GSK Biologicals' HRV vaccine in terms of anti-rotavirus IgA antibody seroconversion at Visit 6 in the group receiving of HRV vaccine concomitantly with OPV versus placebo group.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial for Overweight and Obese Parents to Prevent Childhood Obesity
Brief Summary: To study whether a targeted intervention can prevent the development of overweight and obesity among pre-school children in families with either one obese or two overweight parents.


Options:
A: Infant weight for height (One year after study entry)
B: Change in vegetable intake (Measured at child age of 4-6 months (prior to intervention), 18 months (directly after intervention) and at child age of 24 and 36 months (6 and 18 months follow-up)); Change in vegetable liking (Measured at child age of 4-6 months (prior to intervention), 18 months (directly after intervention) and at child age of 24 and 36 months (6 and 18 months follow-up)); Child self-regulation of energy intake (Measured at child age of 18 months); Change in child self-regulation of energy intake (Measured at child age of 4-6 months (prior to intervention), 18 months (directly after intervention) and at child age of 24 and 36 months (6 and 18 months follow-up))
C: Change in BMIz score (Baseline to 6 months)
D: Body Mass Index score(BMI sds) at the age 6 years to monitor the effectiveness of the intervention (5 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial for Overweight and Obese Parents to Prevent Childhood Obesity
Brief Summary: To study whether a targeted intervention can prevent the development of overweight and obesity among pre-school children in families with either one obese or two overweight parents.


Options:
A: Body Mass Index score(BMI sds) at the age 6 years to monitor the effectiveness of the intervention (5 years)
B: fasting blood glucose (Baseline to 10 months postpartum); weight (body mass index) (Baseline to 10 months postpartum)
C: Infant weight for height (One year after study entry)
D: BMI percentile at 3 years (3 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial for Overweight and Obese Parents to Prevent Childhood Obesity
Brief Summary: To study whether a targeted intervention can prevent the development of overweight and obesity among pre-school children in families with either one obese or two overweight parents.


Options:
A: Child BMI
B: Body Mass Index score(BMI sds) at the age 6 years to monitor the effectiveness of the intervention (5 years)
C: Mean Nutrition Environment Score (Measures collected 3-12 weeks prior to start of intervention (Baseline) and 1-8 weeks post-12-month intervention (Follow-up)); Mean Physical Activity Environment Score (Measures collected 3-12 weeks prior to start of intervention (Baseline) and 1-8 weeks post-12-month intervention (Follow-up))
D: Change in Child Body Mass Index (BMI Z-score) (Change from Baseline at 12 and 21 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial for Overweight and Obese Parents to Prevent Childhood Obesity
Brief Summary: To study whether a targeted intervention can prevent the development of overweight and obesity among pre-school children in families with either one obese or two overweight parents.


Options:
A: Change in glycemic control, change in dietary intake (18 months)
B: Intake of vegetables and fruit (One month)
C: BMI variation from baseline (12 months)
D: Body Mass Index score(BMI sds) at the age 6 years to monitor the effectiveness of the intervention (5 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial for Overweight and Obese Parents to Prevent Childhood Obesity
Brief Summary: To study whether a targeted intervention can prevent the development of overweight and obesity among pre-school children in families with either one obese or two overweight parents.


Options:
A: % Body Fat (Boys) (Baseline and 3 years); BMI Z-score (Boys) (Baseline and three years); % Body Fat (Girls) (Baseline and 3 years); BMI Z-score (Girls) (Baseline and three years)
B: This investigation is an equivalency trial to determine whether weight loss differs between subjects consuming beverages containing no calorie sweeteners as compared to water drinkers at 12 weeks. (Data will be measured at 12 weeks.)
C: N/A
D: Body Mass Index score(BMI sds) at the age 6 years to monitor the effectiveness of the intervention (5 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial for Overweight and Obese Parents to Prevent Childhood Obesity
Brief Summary: To study whether a targeted intervention can prevent the development of overweight and obesity among pre-school children in families with either one obese or two overweight parents.


Options:
A: Parent and child health behaviors (Baseline, 6 months); TV Viewing Time (Baseline, 6 months)
B: Overweight (one school year)
C: body mass index (three years)
D: Body Mass Index score(BMI sds) at the age 6 years to monitor the effectiveness of the intervention (5 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial for Overweight and Obese Parents to Prevent Childhood Obesity
Brief Summary: To study whether a targeted intervention can prevent the development of overweight and obesity among pre-school children in families with either one obese or two overweight parents.


Options:
A: 1-year, and 3-year changes from baseline in questionaires scores for knowledge, attitudes, and habits of children, parents and teachers in regards to a healthy lifestyle. (3 years)
B: BMI percentile at 3 years (3 years)
C: Body Mass Index score(BMI sds) at the age 6 years to monitor the effectiveness of the intervention (5 years)
D: Vitamin D plasma concentrations (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Targeted Approaches to Weight Control for Young Adults
Brief Summary: Obesity represents a chronic disease associated with significant cardiovascular disease (CVD) morbidity and mortality. Weight gain in young adults adversely impacts the development of CVD risk factors. Further, there is a clear relationship between weight loss in obese persons and reduction in these CVD risk factors. Unfortunately, young adults are at high risk for weight gain. Although the scientific literature contains a number of reports regarding successful weight loss efficacy studies, young adults are typically underrepresented.

Cigarette smoking is the leading preventable cause of morbidity and mortality, but quitting smoking frequently results in significant weight gain. Proactive tobacco quit lines using behavioral smoking cessation interventions combined with nicotine replacement therapy (NRT) have been shown to help persons quit smoking. However, concerns about post-cessation weight gain have been reported as a significant barrier to quitting for many smokers particularly young adults.

If an efficacious behavioral weight loss program could be combined with an efficacious behavioral smoking cessation program that prevented or significantly attenuated post-cessation weight gain, then a large public health benefit may result. Such a combined weight loss/ weight gain prevention / smoking cessation program that used targeted intervention strategies to young adults, removed barriers to participation, and utilize interactive technology should be appealing to this age group. To date such a combined program has not been tested in young adult cigarette smokers. Therefore, the objective of this clinical trial is to develop and test a behavioral weight loss / weight gain prevention intervention delivered through interactive technology that can be used in conjunction with an efficacious tobacco quit line. A total of 330 participants will be necessary to adequately address the following specific aims.


Options:
A: Continuous abstinence from smoking from week 9 to week 48 without the use of any other smoking cessation treatments other than trials' treatment (from week 9 to week 48)
B: Body Mass Index (24 months after randomization)
C: 30-day point prevalence tobacco abstinence (6 months); Change in weight (6 months)
D: Efficacy: Smoking abstinence rate (1 year); Efficiency: Incremental Cost-Effectiveness Ratio (1 year)

Answer: B