TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Eight Weeks Treatment, Single Step Titration, Open Label Study Assessing the Percentage of Korean Diabetic Dyslipidemic Patients Achieving LDL Cholesterol Target With Atorvastatin Starting Dose 10mg, 20mg, 40mg
Brief Summary: Because Diabetes Mellitus is one of the major risk factors for CV disease and lots of related evidences have been published including CARDS study that showed definite benefit of statin treatment in DM patients and influenced ADA guideline. \& NCEP ATP III update. However, there are large unmet medical needs for DM patients who don't reach their target LDL-C level defined NCEPT ATP III update because of physicians usually start with the lowest dose of statin and then titrate to the goal. Thus, we are curious about changing our prescription pattern into more tailored way; selecting starting dose based on the individual risk factors and concomitant status will impact the goal achieving rate for DM patients. Besides that, we are going to find out preliminary data about other markers change; small dense LDL and adiponectine;. Small dense LDL-C is more inflammatory and atherogenic LDL-C that may explain the impact of triglyceride. Adiponectin is another good marker related with obesity and metabolic syndrome.


Options:
A: The change of LDL-C (Baseline to 12 weeks)
B: Percentage of subjects in the total LDL cholesterol group achieving their LDL cholesterol target after 8 weeks of treatment. (8 weeks)
C: Percentages changes of the hs-CRP between baseline (means between week-2 to -1 and week 0 (V2) values) and week 26 (V5).
D: Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period (Baseline and Week 8)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Randomized Trial Designed to Evaluate the Applicability of the Guidelines of the Italian Society of Diabetology for the Prevention of Cardiovascular Diseases in Type 2 Diabetes
Brief Summary: Despite several clinical trials have clearly demonstrated that the correction of a single cardiovascular risk factor in patients with type 2 diabetes decreases the incidence of myocardial infarction and other cardiovascular disease (CVD) events, only the Steno study has been evaluating the effect of a multifactorial intervention strategy on macrovascular complications of diabetes. For this reason, the disease management approach currently endorsed by international guidelines (i.e correction of all major CVD risk factors to target levels usually lower than lower risk populations) has not been extensively investigated in terms of prevalence of application in current clinical practice and in terms of real efficacy.

The Multifactorial INtervention in type 2 Diabetes - ITaly (MIND.IT) is a multicentric two-phase study involving 9 Diabetes Care Units throughout Italy with the overall aims of: (1) investigating the degree of application of the international guidelines for CVD prevention in type 2 diabetic patients and (2) verifying whether the application of an intensive multi-factorial intervention inspired by these guidelines is feasible and effective in decreasing the incidence of new CVD events.


Options:
A: Cardiovascular events (5 years of follow up)
B: Treatment according to evidence-based diabetes goals (September 2010 - July 2013); Drug intensification (September 2010 - July 2013); Number of risky prescribing events (September 2010 - July 2013)
C: Multiple CVD risk factor control targets (42 months after randomization)
D: Hemoglobin A1C (Baseline, 6 months and 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Maternal Oral Vitamin D Supplementation Via Daily or Monthly Regimens and the Effect on Levels of Vitamin D in Human Milk and Infant Serum
Brief Summary: Adequate vitamin D is essential for proper infant growth and development. However, human milk is low in vitamin D, and most infants do not receive recommended supplementation. Our aim is to assess the feasibility of providing adequate vitamin D to breastfed infants through maternal vitamin D supplementation. Forty non-pregnant, lactating women at least 18 years of age with exclusively breastfed infants between the ages of 1 and 6 months will be randomized to receive oral vitamin D as either 5,000 IU daily for 28 days or 150,000 IU as a single dose. Maternal serum calcium, phosphorus, vitamin D and 25(OH)D; maternal urinary calcium; maternal milk vitamin D and 25(OH)D will be measured on days 0, 1, 3, 7, 14, and 28 of the study; and infant serum vitamin D and 25(OH)D will be measured on days 0 and 28.


Options:
A: Microbiologically confirmed viral acute respiratory infection (URTI and/or LRTI) (0 to 6 months)
B: The number of days of detectable milk vitamin D concentrations (28 days)
C: serum 25-hydroxyvitamin D concentration, (3 time poits up to 6 months (0-3-6 months))
D: 25-Hydroxyvitamin D Levels for Postpartum Mother 7 Months After Delivery (to 7 months postpartum)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Intravenous GLutamine Supplementation IN Trauma Patients Receiving Enteral Nutrition Study Protocol (GLINT Study): A Prospective, Blinded, Randomized, Placebo-controlled Clinical Trial
Brief Summary: The purpose of this trial is to investigate if pharmacologically safe dose intravenous glutamine dipeptide supplementation to multiple trauma patients receiving enteral nutrition is associated with improved clinical outcomes in terms of decreased organ dysfunction, infectious complications, and other secondary outcomes


Options:
A: -Expression of TLR2 and TLR4 in peripheral blood monocytes was determined by flow cytometry
B: 28-day Mortality (Day 28)
C: The change in daily total Sequential Organ Failure Assessment Score (SOFA)each day over 10 days. (daily until discharge from intensive care unit, death or maximum duration of 10 days.)
D: Time to Discharge Alive (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Metformin Versus Insulin in Gestational Diabetes. A Randomized Controlled Single Center Trial.
Brief Summary: Gestational diabetes is traditionally treated with insulin. Metformin is a peroral drug used worldwide in the treatment of type 2 diabetes and also in a few studies on patients with gestational diabetes. The investigators aim is to compare insulin and metformin in the treatment of gestational diabetes. The investigators hypothesis is that there is no difference between insulin and metformin treated mothers in the main outcome criteria (birth weight, neonatal complications).


Options:
A: Birth Weight Per Arm (delivery)
B: Alive baby (At birth, up to 28 days after birth); Neonatal morbidity (at birth upto 28 days after birth)
C: Number of Participants With Composite Neonatal Morbidity (Delivery through discharge of infant from hospital up to 120 days); Number of Children at the 5-10 Year Followup With BMI ≥ 95th Percentile for Age and Sex (Age 5-10 years)
D: 3rd trimester glycated hemoglobin (3rd trimester of pregnancy); total maternal weight gain (during pregnancy); severe maternal hypoglycemia (from enrollment to delivery); preeclampsia (during pregnancy or puerperium); cesarean section (at the end of pregnancy); gestational age at birth (at birth); preterm birth (at birth); birthweight (at birth); macrosomia (at birth); large-for-gestational age newborn (at birth); small-for-gestational age newborn (at birth); neonatal hypoglycemia (in the neonatal period); perinatal mortality (in the perinatal period); insulin treatment (from enrollment to delivery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An International Phase IV Randomised Trial for Medical and Medico-economic Evaluations of Home-based Disease Management Program in Patients With Gold III/IV Chronic Obstructive Pulmonary Disease.
Brief Summary: The goal of the study is to evaluate a Home-Based Disease Management program specifically developed for patients with Gold III/IV COPD.

By improving disease knowledge, awareness of significant clinical deterioration and self-management skills for patients, this Home-Based COPD Management Program is expected to reduce the severity of exacerbations, the need for emergency hospitalisations, thus demonstrating the efficacy and the cost effectiveness of this intervention.


Options:
A: Number of unscheduled hospital days (up to 12 months)
B: Change in Respiratory Specific Health Related Quality of life (HRQoL) (3 months)
C: Changes in COPD-patients self reported-health, their evaluation of the health system and in the distribution of health resources. (14 months)
D: The proportion of elderly patients hospitalized with the J-44 code as a main reason for admission after interventions vs. control. (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An International Phase IV Randomised Trial for Medical and Medico-economic Evaluations of Home-based Disease Management Program in Patients With Gold III/IV Chronic Obstructive Pulmonary Disease.
Brief Summary: The goal of the study is to evaluate a Home-Based Disease Management program specifically developed for patients with Gold III/IV COPD.

By improving disease knowledge, awareness of significant clinical deterioration and self-management skills for patients, this Home-Based COPD Management Program is expected to reduce the severity of exacerbations, the need for emergency hospitalisations, thus demonstrating the efficacy and the cost effectiveness of this intervention.


Options:
A: Chronic Respiratory Disease Questionnaire (6, 12, and 18 months); 6-minute walk (6, 12, and 18 months)
B: Changes in rate of remission of depression (At 12 months of follow-up)
C: To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of COPD related re-hospitalizations in the intervention versus the control group . (12 months); To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of the composite outcome, COPD related hospitalizations or death in the intervention versus the control group. (12 months)
D: Number of unscheduled hospital days (up to 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An International Phase IV Randomised Trial for Medical and Medico-economic Evaluations of Home-based Disease Management Program in Patients With Gold III/IV Chronic Obstructive Pulmonary Disease.
Brief Summary: The goal of the study is to evaluate a Home-Based Disease Management program specifically developed for patients with Gold III/IV COPD.

By improving disease knowledge, awareness of significant clinical deterioration and self-management skills for patients, this Home-Based COPD Management Program is expected to reduce the severity of exacerbations, the need for emergency hospitalisations, thus demonstrating the efficacy and the cost effectiveness of this intervention.


Options:
A: Health related quality of life (12 month follow-up); Incremental cost-effectiveness ratio (ICER) (12 month follow-up)
B: Number of unscheduled hospital days (up to 12 months)
C: Change in 6-Minute Walk Test Distance (6MWT) (baseline (before intervention), after 10 weeks, after 22 weeks (average of 3 month follow up))
D: Quadriceps Muscle Strength Testing Change (measured at baseline and at ten weeks); Six Minute Walk Test (measured at baseline and at ten weeks); Health-related Quality of Life Assessments Change (measured at baseline and ten weeks); Participant Satisfaction Survey (measured at ten weeks (study completion))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An International Phase IV Randomised Trial for Medical and Medico-economic Evaluations of Home-based Disease Management Program in Patients With Gold III/IV Chronic Obstructive Pulmonary Disease.
Brief Summary: The goal of the study is to evaluate a Home-Based Disease Management program specifically developed for patients with Gold III/IV COPD.

By improving disease knowledge, awareness of significant clinical deterioration and self-management skills for patients, this Home-Based COPD Management Program is expected to reduce the severity of exacerbations, the need for emergency hospitalisations, thus demonstrating the efficacy and the cost effectiveness of this intervention.


Options:
A: Number of hospitalizations (2011)
B: Number of unscheduled hospital days (up to 12 months)
C: Number of hospitalizations due to exacerbation of COPD avoided (1 year)
D: Self-management and Activation (6 Months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An International Phase IV Randomised Trial for Medical and Medico-economic Evaluations of Home-based Disease Management Program in Patients With Gold III/IV Chronic Obstructive Pulmonary Disease.
Brief Summary: The goal of the study is to evaluate a Home-Based Disease Management program specifically developed for patients with Gold III/IV COPD.

By improving disease knowledge, awareness of significant clinical deterioration and self-management skills for patients, this Home-Based COPD Management Program is expected to reduce the severity of exacerbations, the need for emergency hospitalisations, thus demonstrating the efficacy and the cost effectiveness of this intervention.


Options:
A: Number of hospital admissions for exacerbations of COPD
B: Number of unscheduled hospital days (up to 12 months)
C: Hospitalization or Emergency Department Visit for COPD (1 yr); Hospitalization or ED Visit for COPD (Mean Cumulative Frequency) (1 yr)
D: COPD Assessment Test (CAT) (1 Year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multi Site, Randomized, Double Blind, Placebo Controlled, Parallel Group Study Of The Efficacy And Safety Of 2 Oral Doses Of CP- 690,550 And 1 Subcutaneous Dose Of Etanercept In Subjects With Moderate To Severe Chronic Plaque Psoriasis
Brief Summary: To evaluate the efficacy of CP-690,550 as compared to etanercept and the safety of CP-690,550 for treatment of moderate to severe chronic plaque psoriasis.


Options:
A: Percentage of Participants With a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12 (Week 12); Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 (Week 12)
B: Number of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75% Improvement at Week 12 (Week 12)
C: Proportion of subjects who achieve a PGA of 0 or 1 response relative to baseline at Week 12 (12 Weeks); Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 12 (12 Weeks)
D: Number of Subjects With Physician's Global Assessment of Psoriasis (PGA) of Clear or Almost Clear at Week 16 (Week 16)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multi Site, Randomized, Double Blind, Placebo Controlled, Parallel Group Study Of The Efficacy And Safety Of 2 Oral Doses Of CP- 690,550 And 1 Subcutaneous Dose Of Etanercept In Subjects With Moderate To Severe Chronic Plaque Psoriasis
Brief Summary: To evaluate the efficacy of CP-690,550 as compared to etanercept and the safety of CP-690,550 for treatment of moderate to severe chronic plaque psoriasis.


Options:
A: Subject incidence of serious adverse events, including serious infections, non-melanoma skin cancer, and all malignancies, and all adverse events.
B: Psoriasis Area and Severity Index (PASI) 75 Response and Investigators' Global Assessment (IGA) Mod 2011 0 or 1 Response (12 weeks)
C: Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI 90) - ITT (112 and 140 days)
D: Percentage of Participants With a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12 (Week 12); Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 (Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multi Site, Randomized, Double Blind, Placebo Controlled, Parallel Group Study Of The Efficacy And Safety Of 2 Oral Doses Of CP- 690,550 And 1 Subcutaneous Dose Of Etanercept In Subjects With Moderate To Severe Chronic Plaque Psoriasis
Brief Summary: To evaluate the efficacy of CP-690,550 as compared to etanercept and the safety of CP-690,550 for treatment of moderate to severe chronic plaque psoriasis.


Options:
A: Percentage of Participants With a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12 (Week 12); Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 (Week 12)
B: Part B: PASI (Psoriasis Area and Severity Index) Score Mean Percentage of Change Through Day 43 (Through day 43); Part B: All Treatment Adverse Events Reported for Safety Evaluation (85 days); Part A: All Treatment Adverse Events Reported for Safety Evaluation (Cohort 1-4 43 days, Cohort 5-8 64 days)
C: N/A
D: The Number of Visits at Which Participants Achieved a Static Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) (Up to 24 weeks (Week 88 up to Week 112 [total 7 visits]))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multi Site, Randomized, Double Blind, Placebo Controlled, Parallel Group Study Of The Efficacy And Safety Of 2 Oral Doses Of CP- 690,550 And 1 Subcutaneous Dose Of Etanercept In Subjects With Moderate To Severe Chronic Plaque Psoriasis
Brief Summary: To evaluate the efficacy of CP-690,550 as compared to etanercept and the safety of CP-690,550 for treatment of moderate to severe chronic plaque psoriasis.


Options:
A: Part B: PASI (Psoriasis Area and Severity Index) Score Mean Percentage of Change Through Day 43 (Through day 43); Part B: All Treatment Adverse Events Reported for Safety Evaluation (85 days); Part A: All Treatment Adverse Events Reported for Safety Evaluation (Cohort 1-4 43 days, Cohort 5-8 64 days)
B: Number of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA) (Week 12); Number of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI) (Week 12)
C: Percentage of Participants With a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12 (Week 12); Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 (Week 12)
D: Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks) (Baseline to 20 Weeks); Number of subjects prematurely discontinuing due to a Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks) (Baseline to 20 Weeks); Number of subjects reporting at least 1 Serious Adverse Event (SAE) during the Treatment Period (20 Weeks) (Baseline to 20 Weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-Label, Phase 3 Study of Telaprevir Administered Twice Daily or Every 8 Hours in Combination With Pegylated Interferon Alfa-2a and Ribavirin in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus Infection
Brief Summary: The purpose of this study is to evaluate the effectiveness of telaprevir administered twice daily versus every 8 hours in combination with Peg-IFN-alfa-2a and ribavirin in treatment-naïve participants with chronic HCV genotype 1 infection.


Options:
A: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Drugs (SVR12 Planned) (End of trial, 12 weeks after last planned dose)
B: Number of Participant Achieving Rapid Virological Response (RVR) at Day 28, Nominal Analysis (Day 28); Number of Participant Achieving RVR at Day 28, (Primary and Supportive Analyses) (Day 28); Probability of Participants With HCV Genotype 1 Achieving RVR At Day 28, Nominal Analysis (Day 28); Probability of Participants With HCV Genotype 1 Achieving RVR at Day 28, Primary and Supportive Analyses (Day 28); Number of Participants With HCV Genotype 1 With Virologic Response (Day 7, 14 and 21); Change From Baseline in HCV Viral Load During 24 Hour (h) Following a Single Dose of GSK2336805 on the Log 10 Scale (Day 1 (Baseline [Pre-dose], 1, 2, 4, 6, and 8 and 24 h)); Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Event (SAE) During Treatment Period (Up to Day 28); Change From Baseline in QTcF Interval at Day 2 and 28 (Baseline (Day 1, Pre-dose ), Day 2 and Day 28)
C: Sustained Virological Response 12 Weeks Post-treatment (SVR12) (12 weeks post treatment, up to 60 weeks)
D: Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment-Naïve HCV-Infected Participants (Cohort 1 and 2, Panel A) (Week 4); Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment-Naïve HCV-Infected Participants (Cohort 1 and 2, Panel B) (Week 4); Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment-Experienced HCV-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D) (Week 4)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-Label, Phase 3 Study of Telaprevir Administered Twice Daily or Every 8 Hours in Combination With Pegylated Interferon Alfa-2a and Ribavirin in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus Infection
Brief Summary: The purpose of this study is to evaluate the effectiveness of telaprevir administered twice daily versus every 8 hours in combination with Peg-IFN-alfa-2a and ribavirin in treatment-naïve participants with chronic HCV genotype 1 infection.


Options:
A: Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks After the End of Treatment (SVR12) (Week 24 (12 weeks after the end of treatment)); Percentage of Participants Experiencing at Least One Adverse Event (Up to Week 14 (14 days after the Blinded Treatment was completed)); Percentage of Participants Discontinued From Study Treatment Because of an Adverse Event (Up to Week 12 (end of Blinded Treatment))
B: Part 1: Rapid Virological Response (RVR) (4 weeks); Part 2: Sustained Virological Response (SVR) (From drug administration until 12 weeks after end of treatment, up to 52 weeks); Part 3 and 4: Sustained Virological Response (SVR) (From drug administration until 12 weeks after end of treatment, up to 36 weeks)
C: Number of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Planned End of Treatment (EOT) (Week 12 and 24 (for the arms treated for 12 weeks) or Week 24 and 36 (for the arms treated for 24 weeks))
D: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Drugs (SVR12 Planned) (End of trial, 12 weeks after last planned dose)

Answer: D