TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter Study With a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Maintenance Dosing Period and a Long- Term Extension Period to Evaluate the Efficacy and Safety of LY2439821 in Patients With Moderate-to-Severe Plaque Psoriasis
Brief Summary: This study will assess the safety and efficacy of LY2439821 compared to placebo in participants with moderate to severe, chronic plaque psoriasis.


Options:
A: Proportion of patients with at least 75% improvement in PASI from baseline (PASI75) at Week 16. (Baseline to week 16)
B: PASI 75 (16 weeks); Physician Global Assessment, PGA (16 weeks)
C: Percentage of Participants With Static Physician Global Assessment (sPGA) of 0 or 1 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA) (Week 12); Percentage of Participants Achieving ≥75% Improvement in Ps Area and Severity Index (PASI75) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: PASI) (Week 12)
D: The changes in the target (atherosclerotic plaque) to background (blood) ratio (TBR) from the carotid artery and ascending aorta in patients randomized to adalimumab as compared to patients randomized to standard non-systemic therapy. (Day -10 to -1, Day 105)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter Study With a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Maintenance Dosing Period and a Long- Term Extension Period to Evaluate the Efficacy and Safety of LY2439821 in Patients With Moderate-to-Severe Plaque Psoriasis
Brief Summary: This study will assess the safety and efficacy of LY2439821 compared to placebo in participants with moderate to severe, chronic plaque psoriasis.


Options:
A: Percentage of Participants With a Static Physician Global Assessment (sPGA) of (0,1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA]) (Week 12); Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) ≥75% (PASI75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI]) (Week 12)
B: Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) by Drug Delivery Device (Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)); PK: Area Under the Concentration Time Curve From Time Zero to Last Measured Concentration Value (AUC 0-[Tlast]) by Drug Delivery Device (Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration))
C: Percentage of Participants With Static Physician Global Assessment (sPGA) of 0 or 1 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA) (Week 12); Percentage of Participants Achieving ≥75% Improvement in Ps Area and Severity Index (PASI75) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: PASI) (Week 12)
D: Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16 (Week 16); Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16 (Week 16)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter Study With a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Maintenance Dosing Period and a Long- Term Extension Period to Evaluate the Efficacy and Safety of LY2439821 in Patients With Moderate-to-Severe Plaque Psoriasis
Brief Summary: This study will assess the safety and efficacy of LY2439821 compared to placebo in participants with moderate to severe, chronic plaque psoriasis.


Options:
A: The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously in Patients With Moderate to Severe Chronic Plaque-type Psoriasis With Respect to PASI 75 Achievement After 12 Weeks of Treatment, Compared to Placebo. (13 weeks)
B: Change in PASI score from baseline in the two groups (12 weeks)
C: Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 (Week 12); Participants With IGA Mod 2011 0 or 1 at Week 12 (Week 12)
D: Percentage of Participants With Static Physician Global Assessment (sPGA) of 0 or 1 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA) (Week 12); Percentage of Participants Achieving ≥75% Improvement in Ps Area and Severity Index (PASI75) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: PASI) (Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter Study With a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Maintenance Dosing Period and a Long- Term Extension Period to Evaluate the Efficacy and Safety of LY2439821 in Patients With Moderate-to-Severe Plaque Psoriasis
Brief Summary: This study will assess the safety and efficacy of LY2439821 compared to placebo in participants with moderate to severe, chronic plaque psoriasis.


Options:
A: Percentage of Participants With Static Physician Global Assessment (sPGA) of 0 or 1 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA) (Week 12); Percentage of Participants Achieving ≥75% Improvement in Ps Area and Severity Index (PASI75) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: PASI) (Week 12)
B: Percentage of Participants With a Psoriasis Area and Severity Index (PASI)75 Response at Week 16 (Week 16); Number of Participants Experiencing Adverse Events (Up to 72 weeks); Number of Particpants Discontinuing Study Treatment Due to Adverse Events (Up to 52 weeks)
C: Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16 (Baseline and Week 16)
D: Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score (Week 16)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter Study With a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Maintenance Dosing Period and a Long- Term Extension Period to Evaluate the Efficacy and Safety of LY2439821 in Patients With Moderate-to-Severe Plaque Psoriasis
Brief Summary: This study will assess the safety and efficacy of LY2439821 compared to placebo in participants with moderate to severe, chronic plaque psoriasis.


Options:
A: Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16 During the Placebo-Controlled Phase (Baseline and Week 16 of the placebo-controlled phase)
B: Number of Participants Achieving American College of Rheumatology 20 (ACR20) Response Criteria (Week 24)
C: Percentage of Participants With Static Physician Global Assessment (sPGA) of 0 or 1 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA) (Week 12); Percentage of Participants Achieving ≥75% Improvement in Ps Area and Severity Index (PASI75) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: PASI) (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 Phase 3b Multicenter, Double-blind, Randomized, Placebo-controlled Cross-over Efficacy And Safety Study Of Pregabalin In The Treatment Of Patients With Painful Diabetic Peripheral Neuropathy And Pain On Walking
Brief Summary: The intent of this study is to treat subjects with painful Diabetic Peripheral Neuropathy (DPN) who also have pain on walking and to determine whether or not pregabalin demonstrates improvement relative to placebo on the following: reducing DPN pain, reducing pain on walking, and providing other benefits associated with daily activities and quality of life.


Options:
A: Average Diabetic Peripheral Neuropathy (DPN) Pain Based on a Numeric Rating Scale (NRS) Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period) (End of Period (includes both Visits 6 and 11)); DPN Pain on Walking Based on a 11-point NRS of Each Treatment Period (Week 6 of Each Treatment Period) (End of Period (includes both Visits 6 and 11))
B: Whether there is a reduction in subjective pain as assessed by the Brief Pain Inventory. (December 2008)
C: Total pain intensity as measured by numeric rating scale 0-10 points. (Median of ratings from last week of each treatment period)
D: Daily Pain Rating Scale (DPRS)- Mean Pain Score (ITT Population) (Endpoint- Week 8 or Early Discontinuation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Asthma and Health Literacy in Newcomer Communities in the Greater Vancouver Area (GVA): A Population-based Qualitative Study
Brief Summary: In this study, the investigators aim to develop and test the effectiveness of culturally appropriate asthma videos and other educational materials based on knowledge from this study and the investigators' previous studies. By culturally appropriate materials the investigators mean to develop health information (in the format of video and written materials) in the community own language and applied the most appealing cultural beliefs and practices in the Chinese and Punjabi communities. The investigators also aim to recommend a practical framework and to develop a measure of asthma knowledge and health literacy among immigrants from the Punjabi and Chinese communities in BC. The investigators' definition of health literacy in this study is the capability of a person to navigate and access to asthma-related information, as well as to understand, evaluate, and communicate the obtained information to improve his/her health status. The investigators' hypothesis is that audio-visual based asthma information in a subject's native language would improve a patient's knowledge and self-management of asthma in comparison to printed information.


Options:
A: ART adherence (Every 3 months up to 12 months); HIV-1 viral load (Every 3 months up to 12 months); Sexual risks (Every 3 months up to 12 months); Clinic visit adherence (Every 3 months up to 12 months)
B: medication adherence (on year)
C: adherence to dietary sodium targets as assessed from 3-day food recalls (baseline and 4 months); average daily interdialytic weight gain (IDWG) (IDWG gathered with each dialysis treatment); average pulse pressure from pre-dialysis blood pressures (with each dialysis treatment)
D: Glycemic Control (12 months.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Asthma and Health Literacy in Newcomer Communities in the Greater Vancouver Area (GVA): A Population-based Qualitative Study
Brief Summary: In this study, the investigators aim to develop and test the effectiveness of culturally appropriate asthma videos and other educational materials based on knowledge from this study and the investigators' previous studies. By culturally appropriate materials the investigators mean to develop health information (in the format of video and written materials) in the community own language and applied the most appealing cultural beliefs and practices in the Chinese and Punjabi communities. The investigators also aim to recommend a practical framework and to develop a measure of asthma knowledge and health literacy among immigrants from the Punjabi and Chinese communities in BC. The investigators' definition of health literacy in this study is the capability of a person to navigate and access to asthma-related information, as well as to understand, evaluate, and communicate the obtained information to improve his/her health status. The investigators' hypothesis is that audio-visual based asthma information in a subject's native language would improve a patient's knowledge and self-management of asthma in comparison to printed information.


Options:
A: Percentage of Participants With MDI Misuse From Baseline to 30 Days Post-Discharge (1 month)
B: Change in inhaler, turbuhaler, and diskus technique (Baseline and 1-month follow-up)
C: Adherence rate (at three months)
D: medication adherence (on year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Asthma and Health Literacy in Newcomer Communities in the Greater Vancouver Area (GVA): A Population-based Qualitative Study
Brief Summary: In this study, the investigators aim to develop and test the effectiveness of culturally appropriate asthma videos and other educational materials based on knowledge from this study and the investigators' previous studies. By culturally appropriate materials the investigators mean to develop health information (in the format of video and written materials) in the community own language and applied the most appealing cultural beliefs and practices in the Chinese and Punjabi communities. The investigators also aim to recommend a practical framework and to develop a measure of asthma knowledge and health literacy among immigrants from the Punjabi and Chinese communities in BC. The investigators' definition of health literacy in this study is the capability of a person to navigate and access to asthma-related information, as well as to understand, evaluate, and communicate the obtained information to improve his/her health status. The investigators' hypothesis is that audio-visual based asthma information in a subject's native language would improve a patient's knowledge and self-management of asthma in comparison to printed information.


Options:
A: Follow-up with a Primary Care Physician (PCP) (4 weeks, 3 months and 6 months after Emergency Department visit)
B: medication adherence (on year)
C: Emergency Department Visits - 1st time point (12 months prior to baseline interview); Emergency Department Visits - 2nd time point (Interval between baseline and 9 months); Emergency Department Visits - 3rd time point (interval between 9 month and 18 month telephone interview)
D: ER visits (18 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I/II Study of Cellular Immunotherapy With Donor Central Memory-derived Virus-specific CD8+ T-cells Engineered to Target CD19 for CD19+ Malignancies After Allogeneic Hematopoietic Stem Cell Transplant
Brief Summary: This phase I/II trial studies the safety and toxicity of post-transplant treatment with donor T cells engineered to express a chimeric antigen receptor (CAR) targeting CD19 in patients who have had a matched related allogeneic hematopoietic stem cell transplant for a CD19+ B cell malignancy.


Options:
A: Percent of participants recieving pembrolizumab per protocol schedule (21 days after first pembrolizumab infusion); Dose Timing part: Incidence of dose limiting toxicities (DLTs) (21 days after first pembrolizumab infusion); Expansion part: Overall response rate (ORR) (3 month post tisagenlecleucel infusion)
B: Safety and toxicity assessment of study treatment (Up to day 42 after the T cell infusion); Feasibility assessment of study treatment (Up to 5 years)
C: Event-free survival (EFS) (Approximately 3 years)
D: Adverse events attributed to Tcm adoptive transfer as reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Up to 15 years); MTD of CD19-CAR-specific/truncated EGFR lentiviral vector-transduced autologous T cells based on dose limiting toxicities (Up to day 28)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Step Monitoring to Improve ARTERial Health
Brief Summary: Many people with diabetes and/or high blood pressure (hypertension) are not very active. When people are more active, they can reduce the chances of having a heart attack or stroke. Walking more is a cheap and effective way to be more active and to lower the risk of heart attacks and strokes. The problem is that many people do not walk enough! The investigators will study if people with diabetes and/or hypertension walk more when the doctor gives them a prescription with the number of steps they should be walking every day. The investigators will compare this group, called 'active', to another group, called 'control', in which doctors and their patients do what they usually do, over a period of one year.

The investigators will measure the number of steps the investigators walk everyday with a step counter or pedometer. In the step count prescription group, the doctors will give to the 'active' group a pedometer, a step count record book, and step count prescriptions. The overall goal is to gradually increase daily steps. The speed of the increase in step count will be slower for less active people. At each visit the doctor will look at the step count record book. The doctor will then give a new step count prescription to the patients. Patients of the two groups will see their doctor about four times during the year, which is how often they usually see their doctor. At the end of one year, the investigators will see the difference in the hardness of the arteries between the 'active' and the 'control' groups, using simple and safe measurements, similar to ultrasound in pregnant ladies. People with hard arteries are more likely to have a heart attack or stroke.

The investigators suspect that patients who get the step count prescriptions will walk more and their arteries will be less hard than the control group. Our study will help find out if this is true. In that case, doctors should take the time to prescribe steps for all their patients with diabetes and/or hypertension.


Options:
A: Aerobic fitness (before and after the 10 week intervention)
B: Physical activity level (At the begining of the intervention and after 9 months.); Cardiovascular risk. (At the begining of the intervention and after 9 months); Biochemical analysis. (At the begining of the intervention and after 9 months.); Antropometric measurements. (At the begining of the intervention and after 9 months.); Frequency of food consumption (At the begining of the intervention and after 9 months.); Health related quality of life (At the begining of the intervention and after 9 months.)
C: change in arterial stiffness (one year)
D: Resting systolic blood pressure (3 Months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity and Safety of Different Sequential Schedules of Inactivated Poliomyelitis Vaccine (IMOVAX Polio®) Followed by Oral Poliomyelitis Vaccine in Healthy Infants in China Versus Oral Poliomyelitis Vaccine Alone.
Brief Summary: The purpose of this study is to generate data to support the registration extension of IMOVAX Polio to be used in a sequential vaccination.

Primary objective:

* To demonstrate the non-inferiority of Inactivated Poliomyelitis Vaccine (IPV)-(Oral Poliomyelitis Vaccine) (OPV)-OPV (Sequential 1) and IPV-IPV-OPV (sequential 2) poliovirus vaccine administrations versus OPV-OPV-OPV (Reference) in terms of seroprotection rate 28 to 42 days after the third dose of the primary vaccination series.

Secondary objectives:

* To evaluate the safety profile of the investigational vaccines after each administration in each group.
* To describe the humoral immune response to poliovirus serotypes (types 1, 2 and 3) before the first dose and 28 to 42 days after the third primary series dose of vaccine in each group.
* To describe the persistence of antibodies against poliovirus serotypes (types 1, 2 and 3) after the third primary series dose administration, at 18 months of age in each group.


Options:
A: Mortality by sex
B: Number of Subjects With Any and Grade 3 Solicited Local Symptoms (During the 4-day (Days 0-3) post-vaccination period); Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms (During the 4-day (Days 0-3) post-vaccination period); Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) (During the 31-day (Days 0-30) post-vaccination period); Number of Subjects With Serious Adverse Events (SAEs) (During the entire study period (from Day 0 to Month 1))
C: Neutralizing antibody titers ≥8 (1/dil) against each of the 3 poliovirus serotypes (types 1, 2 and 3) after the 3 dose primary vaccination series. (1 month post-dose 3 (primary vaccination series))
D: Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 (At Month 3, one month after the third vaccine dose)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: REPLACE (Randomized Evaluation of Fibrinogen Versus Placebo in Complex Cardiovascular Surgery): a Prospective, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Study for the Use of Fibrinogen Concentrate (Human) (FCH) in Complex Cardiovascular Surgery
Brief Summary: The purpose of this study is to demonstrate that Fibrinogen Concentrate (Human)(FCH) can reduce the amount of donor blood products needed during complex cardiovascular surgery, and that it is safe and well tolerated. Subjects in this study will get either a FCH or placebo infusion during surgery. This will be in addition to the standard treatment, which is donor blood or blood products. Placebo does not contain any effective medicine.

The study is randomised. This means that the likelihood that subjects will get FCH or placebo is 50%. To make the comparison between FCH and placebo as fair as possible, the study is "double blind". This means that neither the subjects nor the study doctor will know if FCH or placebo is administered. If necessary, the study doctor can find out which treatment the subjects are receiving.


Options:
A: To evaluate safety of prophylactic fibrinogen infusion in patients with fibrinogen levels in the lower normal range undergoing cardiac surgery (2 years); Blood loss first 12 postoperative hours (12h)
B: Multiple Organ Failure (MOF) (Variable until 24h on ICU at the end of the IMP-administration)
C: Total units of allogeneic blood products (Up to 24 hours after investigational medicinal product (IMP) administration)
D: To determine whether fibrinogen concentrate infusion reduces perioperative blood loss. (within 12 hours.)

Answer: C