TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Prospective, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate Smoking Cessation With Varenicline Tartrate Compared With Placebo In The Setting Of Patient Self-Selected (Flexible) Quit Date
Brief Summary: The hypothesis is that varenicline will be effective (compared with placebo) for smoking cessation when subjects are allowed to set their own quit date within the first 5 weeks of treatment.


Options:
A: Cotinine Level (Baseline, 4 weeks, 8 weeks); Change From Baseline in Cognitive Performance (basline and 8 weeks (or end of study iif patient ended participation before the 8-weeks))
B: Primary Patient Acceptability A: Rate of Patient Wanting Provider to Use QA-DDS (Immediately Post-Consultation up to 1 week); Primary Patient Acceptability B: Rate of Patient Wanting to Use QA-DDS Patient Portal (1-Month Follow-Up); Primary Patient Feasibility A: Rate of Patient Completion of 1-Month Follow-Up Survey (1-Month Follow-Up)
C: Self-reported continuous abstinence of smoking and exhaled carbon monoxide levels less than 10 ppm as measured and recorded by the research nurse at weeks 12 and 52. (1 year)
D: Percentage of Participants With 4-week Continuous Abstinence (CA) (Week 9 through Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Prospective, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate Smoking Cessation With Varenicline Tartrate Compared With Placebo In The Setting Of Patient Self-Selected (Flexible) Quit Date
Brief Summary: The hypothesis is that varenicline will be effective (compared with placebo) for smoking cessation when subjects are allowed to set their own quit date within the first 5 weeks of treatment.


Options:
A: Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. (Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).)
B: Percentage of Participants With 4-week Continuous Abstinence (CA) (Week 9 through Week 12)
C: Change in Smoking Behavior (Change in cigarettes per day from Week 2 to Week 5)
D: continuous abstinence (CAR) from weeks 9 to 12 of treatment (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Brief Summary: Compare the efficacy of ABT-874 versus etanercept in subjects with moderate to severe plaque psoriasis


Options:
A: 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)
B: 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)
C: Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) . (12 wks); Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12 (12 wks)
D: Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (Week 12); Percentage of PASI Improvement From Baseline to 12 Week Endpoint (Baseline to Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Brief Summary: Compare the efficacy of ABT-874 versus etanercept in subjects with moderate to severe 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: 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)
C: 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)
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: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Brief Summary: Compare the efficacy of ABT-874 versus etanercept in subjects with moderate to severe plaque psoriasis


Options:
A: Proportion of subjects with clinical response relative to Baseline PASI score (Week 12, Week 40 and Week 60)
B: Percentage of Participants With Psoriasis Area Sensitivity Index 75 (PASI-75) Response at Week 12 (Base Study) (Week 12 (or end of trial if prior to Week 12)); Percentage of Participants With a Physician's Global Assessment (PGA) Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 12 (Base Study) (Baseline and Week 12 (or end of trial if prior to Week 12)); Number of Participants Experiencing an Adverse Event Up to Week 12 (Base Study) (Up to 12 weeks); Number of Participants Discontinuing Study Drug Due to an Adverse Event Up to Week 12 (Base Study) (Up to 12 weeks); Number of Participants Discontinuing Study Drug Due to a Drug-Related Adverse Event (Base Study) (Up to 12 weeks)
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: Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0) (Week 0 and Week 16)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Brief Summary: Compare the efficacy of ABT-874 versus etanercept in subjects with moderate to severe plaque psoriasis


Options:
A: Number of Subjects With Physician's Global Assessment of Psoriasis (PGA) of Clear or Almost Clear at Week 16 (Week 16)
B: 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)
C: 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)
D: Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 (Week 12); Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 by Anti-adalimumab Antibody Status (Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Study for Prostate Cancer, Randomizing Between Two Radiation Dose Levels (68 Gy vs. 78 Gy) and Utilizing Three Dimensional Conformal Radiotherapy
Brief Summary: 3-D conformal radiotherapy offers the opportunity to reach higher tumor doses with acceptable complication rates compared to conventional radiotherapy. There are retrospective and preliminary prospective reports of a better local control / disease free survival (including PSA control) using higher tumor doses. A prospective randomised phase III study is required to validate these reports. The purpose of this randomized phase III study is to investigate and compare the tumor control and toxicity in prostate cancer patients treated to 68 Gy and 78 Gy;


Options:
A: Interval before biochemical failure (10 years)
B: Disease specific mortality (Median 15 years follow up)
C: Biochemical or clinical progression-free survival at 5 years (5 years)
D: Freedom from failure

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Approaches to Correcting Vitamin D Inadequacy and Maintaining Adequacy
Brief Summary: Vitamin D is available in two forms, vitamin D2 and vitamin D3. It has previously been assumed that these two forms maintain blood vitamin D equally. However, this may not be the case. This study will evaluate whether D2 and D3 produce equal elevation of blood vitamin D. Additionally, it will evaluate whether once per month vitamin D dosing is as effective in maintaining blood vitamin D levels as daily dosing.


Options:
A: Incidence of spontaneous falls. (24 months.)
B: Chang in Disposition Index, a Measure of Beta Cell Function (baseline and 4 months)
C: The primary outcome measure is change in 25OHD with various D2 and D3 dosing regimens. (12 months)
D: Number of Participants With the Indicated Components of the Composite Cardiovascular Outcome for Thiazolidinedione (TZD) (From Randomization at Visit 3 up to the Final Visit (average of 162 days)); Number of Participants With the Indicated Components of the Composite Outcome for Vitamin D (From Randomization at Visit 3 to Final Visit (up to 162 days))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Approaches to Correcting Vitamin D Inadequacy and Maintaining Adequacy
Brief Summary: Vitamin D is available in two forms, vitamin D2 and vitamin D3. It has previously been assumed that these two forms maintain blood vitamin D equally. However, this may not be the case. This study will evaluate whether D2 and D3 produce equal elevation of blood vitamin D. Additionally, it will evaluate whether once per month vitamin D dosing is as effective in maintaining blood vitamin D levels as daily dosing.


Options:
A: AUC for increment in serum 25(OH)D (12 weeks)
B: Change in body weight (Baseline and at 16 weeks)
C: Serum calcium (at each dose change)
D: The primary outcome measure is change in 25OHD with various D2 and D3 dosing regimens. (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Family Based Intervention for Adolescent Suicide Attempters
Brief Summary: This study will evaluate the effectiveness of an individually tailored suicide prevention treatment program called SAFETY in reducing suicide and suicide attempts in adolescents.


Options:
A: First recurrent suicide behavior (suicide attempted and completed suicide) (Minimum 1.5 year)
B: Suicide Attempt (3-months); Suicide-related hospitalizations (Measured at month 3)
C: Suicide repetition (or death by suicide) (12 months)
D: Acceptability of the intervention assessed by the number of therapy sessions completed by participants in the intervention arm. (2 years); Incidence of Treatment-Emergent Adverse Events as assessed by the adverse experiences in psychotherapy self-reported measure (2 years); Feasibility of the intervention assessed by the number of assessments completed by participants in the intervention arm (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pain, Sexual Dysfunction and Depression in Hemodialysis Patients
Brief Summary: This study is seeking to identify the most effective strategy to manage pain, sexual dysfunction, and depression in patients receiving chronic hemodialysis therapy.


Options:
A: Overall Screening Adherence (12 months)
B: To determine the effect of a phosphorus additives educational intervention on serum phosphorus levels. (3 months)
C: Time Specific Interdialytic Weight Gain (Baseline) (Baseline); Time Specific Interdialytic Weight Gain (8 Weeks) (8 weeks); Time Specific Interdialytic Weight Gain (12 Weeks) (12 weeks); Time Specific Interdialytic Weight Gain (16 Weeks) (16 weeks); Time Specific Dietary Sodium Intake (Baseline) (Baseline); Time Specific Dietary Sodium Intake (8 Weeks) (8 weeks); Time Specific Dietary Sodium Intake (16 Weeks) (16 weeks); Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 8 Weeks) (Baseline to 8 weeks); Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 16 Weeks) (Baseline to 16 weeks)
D: Change in Pain, Sexual Dysfunction, and Depression Symptoms (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Pain, Sexual Dysfunction and Depression in Hemodialysis Patients
Brief Summary: This study is seeking to identify the most effective strategy to manage pain, sexual dysfunction, and depression in patients receiving chronic hemodialysis therapy.


Options:
A: The primary outcome for this study is the proportion of enrolled patients with live donor kidney transplants. (one year)
B: To determine the effect of a phosphorus additives educational intervention on serum phosphorus levels. (3 months)
C: Comparison of Average Immunosuppressant Therapy Adherence for 12-month Study Period (12 months)
D: Change in Pain, Sexual Dysfunction, and Depression Symptoms (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Diet Composition - Metabolic Regulation and Long-term Compliance
Brief Summary: This study will compare a high-protein/low-carbohydrate diet (modified paleolithic diet, MPD) with a diet high in slow carbohydrates (Nordic Nutrition Recommendations, NNR). The diets will be compared with respect effects on weight reduction, metabolic regulation, and long-term compliance to the diet regimes. Seventy-two postmenopausal overweight healthy women have been recruited and will be followed for two years.

The following variables will be studied:

* Anthropometry
* DEXA
* OGTT
* Liver fat content measured with 1H-MRS
* Hepatic 11β-HSD1 activity, measured with cortisone/cortisol conversion test


Options:
A: LDL size (baseline and after each of 6 interventions)
B: Body Weight (12 weeks); Body Composition (12 weeks); Energy Intake (12 weeks); Appetite (12 weeks); Energy Expenditure (12 weeks)
C: Laboratory findings and body composition (2 years)
D: Liver fat (Sept 2008)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Diet Composition - Metabolic Regulation and Long-term Compliance
Brief Summary: This study will compare a high-protein/low-carbohydrate diet (modified paleolithic diet, MPD) with a diet high in slow carbohydrates (Nordic Nutrition Recommendations, NNR). The diets will be compared with respect effects on weight reduction, metabolic regulation, and long-term compliance to the diet regimes. Seventy-two postmenopausal overweight healthy women have been recruited and will be followed for two years.

The following variables will be studied:

* Anthropometry
* DEXA
* OGTT
* Liver fat content measured with 1H-MRS
* Hepatic 11β-HSD1 activity, measured with cortisone/cortisol conversion test


Options:
A: Liver fat (Sept 2008)
B: N/A
C: weight loss
D: body weight in kilograms as measured by a calibrated scale (0,1,2,3,4,5,and 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Personal Patient Profile Prostate (P4) Randomized, Multisite Trial
Brief Summary: The purpose of this study is to determine whether or not participation in an experimental program called the "P4 program" is useful to men who are faced with choices about treatment for their early stage prostate cancer. The P4 program consists of a series of questions and information for the participant.

Before seeing the cancer specialist, participants will answer several questionnaires on a computer. This will take about 20-30 minutes. Participants may choose to do this on a computer at home or on a touch-screen computer in the clinic. Half the participants will then be shown several highly rated informational websites about prostate cancer treatments. The other half, based on the individual participant's answers, will receive the P4 program's customized written and on-screen information. Reading the information and watching videos will take about 20 minutes.

About one month later, and again 6 months, participants will complete follow-up questionnaires electronically or by mail. These questionnaires will help us understand how each participant's decision for treatment of their prostate cancer went. Answering these questionnaires should take about 20 minutes each time.


Options:
A: Patient knowledge (Immediately after patient visit)
B: Evidence of success of decision aid to providers and patients, which leads to improved knowledge, reduced decisional conflict and enhanced satisfaction with the decision, and enhanced adherence to medication. (Directly following intervention.)
C: Discussion with provider about CHD risk reduction; Stated plans for CHD risk reduction
D: Decisional Conflict (Baseline to 6 months); Decisional Satisfaction (Baseline to 6 months); Satisfaction with Preparation for Decision Making (Baseline to 1 month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Standard vs. Washed Blood Cell Transfusions in Pediatric Cardiac Surgery: Impact on Post-operative Inflammation as Evidenced by the IL-6 to IL-10 Ratio.
Brief Summary: Background: Children having open heart surgery to repair congenital heart defects demonstrate a large inflammatory response to the heart-lung machine and to surgery itself. In general, the more intense their inflammatory response, the more critically ill they are following surgery. These children routinely require large numbers of blood transfusions during and following surgery as part of their medical management that adds to their heightened inflammatory state. Whether additional steps to "wash" blood products and remove the substances contributing to post-transfusion inflammation will limit this response, and improve the health of children following open heart surgery, remains to be studied.

Aims: To compare the inflammatory response in children having open heart surgery who receive washed versus unwashed blood transfusions.

Methods: We will randomly assign children having open heart surgery to one of two groups: group 1 will receive blood transfusions per the current standard of care, group 2 will receive blood transfusions that have been washed in addition to the current standard of care. We will then use blood tests to measure the inflammatory response in children of each group. We will compare the results to determine whether washing blood transfusions decreases inflammation and post-operative complications following open heart surgery.

Conclusion: We believe that washing blood transfusions given to children following open heart surgery will decrease their inflammatory response and improve their overall health.


Options:
A: The Change in the Composite Multiple Organ Dysfunction Score (MODS) From the Pre-operative Baseline. The Worst Post-operative Values of Each Component of MODS Will be Used to Calculate the Change in MODS. (Through post-operative day 7, hospital discharge, or death, whichever occurs first)
B: 12 Hour Plasma Interleukin (IL)-6 to IL-10 Ratio (12 hours post-cardiopulmonary bypass)
C: Combined mortality or survival to tertiary hospital discharge without severe morbidity (BPD, severe ROP or brain injury) (neonatal phase); Combined mortality or survival with neurodevelopmental disability (non-ambulatory cerebral palsy, blindness, deafness, cognitive delay) (follow-up phase 18 months corrected age)
D: Serum lactate levels (measured 1 hour after surgery); Developmental outcome (measured by Bayley Scales of Infant Development at age 1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Controlled Comparative Study of the Efficacy of SARNA Sensitive Lotion for Treatment of Uremic Pruritus in Adult Hemodialysis Patients
Brief Summary: The purpose of this research study is to evaluate the efficacy of SARNA Sensitive Lotion in the treatment of uremic pruritus in adult hemodialysis patients in a double-blind Controlled comparative trial.


Options:
A: Reduction of Itch Intensity as Assessed by the Percentage of Patients Achieving an Improvement From Baseline ≥3 Points With Respect to the Weekly Mean of the Daily 24-hour Worst Itching Intensity Numerical Rating Scale (NRS) Score at Week 12 (Week 12)
B: Investigator Global Assessment (Disease severity assessed at baseline and 4 weeks, week 4 reported)
C: Reduction of Itch Intensity as Assessed by the Percentage of Patients Achieving an Improvement From Baseline ≥3 Points With Respect to the Weekly Mean of the Daily 24-hour Worst Itching Intensity Numerical Rating Scale (NRS) Score at Week 12 (Week 12)
D: VAS change from baseline (the change in VAS between visit 2 (week 0) and visits 3, 4, 5, and 6 (weeks 2, 4, 8, 10))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: International Study to Predict Optimised Treatment - in Depression
Brief Summary: The aim of this study is to identify genetic, physical (brain) and psychological (cognitive) markers (or combinations of them) that predict specific response to a range of antidepressants treatment (Escitalopram, Venlafaxine, Sertraline) in patients diagnosed with major depressive disorder. This study is focused on outcomes which may impact on how "personalised medicine" is implemented in depression.


Options:
A: Primary outcomes were MADRS (depression), HAM-A (anxiety), CERAD (cognitive test) and alcohol consumption (time line follow backup).
B: Subjects self-report of alcohol use, measured by the Timeline Followback (TLFB), and depressive symptoms measured by scores on the Beck Depression Inventory (BDI) and Hamilton Rating Scale for Depression (HRSD). (14 weeks)
C: Change in Mean Score on the Hamilton Rating Scale for Depression -- 17 Items (HAM-D-17) (From baseline visit to Week 12 (or early discontinuation visit)); Total Drinking Days on the Alcohol Timeline Followback (TLFB) (From Baseline visit to Week 12 (or early discontinuation visit)); Total Drinks Consumed Per Week on the TLFB (From Baseline visit to Week 12 (or early discontinuation visit)); Total Drinks Consumed Per Drinking Day on the TLFB (From Baseline visit to Week 12 (or early discontinuation visit))
D: To determine whether the genetic-brain-cognition function markers (or combination of markers) 'normalise' with acute drug treatment in MDD (Week 8)

Answer: D