TrialPanorama/Dataset huggingface dataset:
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 In Subjects With Moderate To Severe Chronic Plaque Psoriasis
Brief Summary: The main objective of this study is to compare the effects of CP-690,550 with the effects of placebo in patients being treated for moderate to severe chronic plaque psoriasis. This one-year study will also evaluate the safety and tolerability of CP-690,550 versus placebo.


Options:
A: 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)
B: Visual Analog Scale (6 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 Who Achieved Success in Investigator's Static Global Assessment (ISGA) Score at Day 29 (Day 29); Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) (AEs: Baseline (Day 1) up to Day 29, SAEs: Baseline (Day 1) up to Day 36); Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings at Day 8 (Baseline, Day 8); Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Day 36 (Baseline (Day 1), Day 36); Number of Participants With Clinically Significant Laboratory Values (Baseline up to Day 36); Percentage of Participants With Local Tolerability Symptoms at Baseline (Baseline (Day 1)); Percentage of Participants With Local Tolerability Symptoms at Day 8 (Day 8); Percentage of Participants With Local Tolerability Symptoms at Day 15 (Day 15); Percentage of Participants With Local Tolerability Symptoms at Day 22 (Day 22); Percentage of Participants With Local Tolerability Symptoms at Day 29 (Day 29); Percentage of Participants With Local Tolerability Symptoms at Day 36 (Day 36)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Immunogenicity of Monovalent H5N1 Vaccine GSK1557484A in Children 6 Months to < 18 Years of Age
Brief Summary: This study will assess safety and immunogenicity of GSK Biologicals' H5N1 flu candidate vaccine GSK1557484A in children 6 months to \< 18 years of age.


Options:
A: Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain. (At Day 42.)
B: Number of Subjects (Unprimed) 6 to <36 Months Age With Local and Systemic Reactions After Any Vaccination for All Seasons, Comparison of Adjuvanted Trivalent Influenza Vaccine (aTIV) and Flu Vaccine Control. (7 days post-vaccination); Percentage of Subjects (Unprimed) Aged 6 to <36 Months With Virus-Confirmed Influenza, Comparison of aTIV and Non-flu Vaccine Control (Men C/TBE Vaccine) (3 weeks after 2nd vaccination)
C: The primary efficacy endpoint of this study is the relative efficacy of CAIV-T; compared to TIV against the incidence of culture-confirmed symptomatic influenza infection caused by community-acquired wild-type strains antigenically similar to those contained in the vaccine, occurring during the; influenza surveillance period and at least 14 days after the last required vaccination
D: Laboratory-confirmed influenza infection. (up to 3 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-centre, Open-labeled, Randomized, Parallel Study on Liver Fat Content and Visceral Fat Mass in Overweight and Obese Type 2 Diabetes Patients After 26 Weeks Treatment With Insulin Detemir Once Daily Versus Insulin NPH Once Daily
Brief Summary: Primary objective:

To compare the change in liver fat content and visceral fat mass (cm2) assessed by MRS (Magnetic Resonance Spectroscopy) and MRI (Magnetic Resonance Image), after 26 weeks of treatment with insulin detemir once daily or insulin NPH once daily both with metformin in overweight and obese type 2 diabetic subjects.

Secondary objectives:

To compare the two treatments with respect to:

1. Efficacy:

   * MRI: abdominal subcutaneous fat mass(cm2), Calculated Visceral/Subcutaneous Adipose Tissue Ratio.
   * Change in HbA1c from baseline at 12 and 26 weeks of treatment.
   * Change in Fasting plasma glucose from baseline at 12 and 26 weeks of treatment.
   * Weight
   * Waist and hip circumference
2. Safety:

   * Incidence of hypoglycaemia in the 26 weeks of treatment with insulin detemir versus NPH
   * Lipid profile at the start and after 26 weeks of treatment
   * Incidence of Adverse events during the trial
   * Safety profile as measured by laboratory safety parameters (haematology, biochemistry) and physical examination/vital signs before and at the end of treatment


Options:
A: The change in liver fat content and visceral fat mass (After 26 weeks of treatment)
B: Change in HbA1c (percentage %) (Baseline to 6 Months)
C: Glycemic variability (24 weeks)
D: Body weight loss (after 26 weeks of treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: RENEWING HEALTH Large-scale Real-life Study in Finland
Brief Summary: The purpose of this trial is to determine if by structured telephone based health coaching programme supported by remote monitoring system among type 2 diabetes, coronary artery disease and heart failure patients the investigators are able to improve their quality of life as measured by the SF-36 questionnaire and reduce a value of HbA1c under 6,5 % among those type 2 diabetes patients who had elevated value of HbA1c when recruited.


Options:
A: Change in self-care behaviour measured with the validated European Heart Failure Self Care Behaviour Scale(EHFScB scale) (at 3, 6 and 12 months); Change in health related quality of life measured with the generic short-form health survey with 36 questions (SF36), EuroQol five Dimensions (EQ-5D) and the disease-specific Minnesota Living with Heart Failure Questionnaire (MLHFQ) (at 3, 6 and 12 months)
B: days alive and out of hospital (up to 2 years)
C: Lifestyle (3 months); Quality of Life (QoL) (3 months); Behavioral flexibility (3 months)
D: Health related quality of life (12 months); HbA1c change over time (participants with T2DM only) (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: RENEWING HEALTH Large-scale Real-life Study in Finland
Brief Summary: The purpose of this trial is to determine if by structured telephone based health coaching programme supported by remote monitoring system among type 2 diabetes, coronary artery disease and heart failure patients the investigators are able to improve their quality of life as measured by the SF-36 questionnaire and reduce a value of HbA1c under 6,5 % among those type 2 diabetes patients who had elevated value of HbA1c when recruited.


Options:
A: Health related quality of life (12 months); HbA1c change over time (participants with T2DM only) (12 months)
B: Hemoglobin A1c (12 months); Systolic Blood Pressure (12 months)
C: Change in the proportion of patients achieving glycaemic and BP control (1 year)
D: Insulin Prescription Rate - the Number of Insulin-eligible Patients Per 12 Months Who Are Prescribed Insulin in Each Family Physician (FP) Practice (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: RENEWING HEALTH Large-scale Real-life Study in Finland
Brief Summary: The purpose of this trial is to determine if by structured telephone based health coaching programme supported by remote monitoring system among type 2 diabetes, coronary artery disease and heart failure patients the investigators are able to improve their quality of life as measured by the SF-36 questionnaire and reduce a value of HbA1c under 6,5 % among those type 2 diabetes patients who had elevated value of HbA1c when recruited.


Options:
A: Rate of Recurrence of Atrial Arrhythmias (Six months); Time to Treatment for Recurrence of Atrial Arrhythmia (Six months); Number of Intervention and Control Group Patients Treated for Recurrent Atrial Arrhythmia (6 months)
B: Reduction of Non-HDL cholesterol (6 months)
C: Brain Natriuretic Peptide values (Baseline, 6 months); Self-care practices measured through Self-Care of Heart Failure Index scores and interviews (baseline, 6 months); Health related quality of life measured through the Minnesota Living with Heart Failure Questionnaire scores and interviews (baseline, 6 months)
D: Health related quality of life (12 months); HbA1c change over time (participants with T2DM only) (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Therapy for Acute Gout: Does Initial Use of Allopurinol Effect Duration and/or Recurrence Rate of Acute Attacks
Brief Summary: Medical teaching suggests allopurinol should not be initiated in the setting of an acute attack of gout, as rapid lowering of serum urate may exacerbate the attack. This study tests the hypothesis that there is no difference in patient reported daily pain or flair occurrences with early versus delayed institution of allopurinol during an acute gout attack.


Options:
A: Daily pain scores and recurrence attack rate. (30 days after initiation of treatment)
B: Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL). (Last 3 visits (any last 3 visits up to week 28))
C: Percentage of Subjects Whose Serum Urate Level is <6.0 Milligrams Per Deciliter (mg/dL) at the Final Visit. (Last Visit on treatment (up to 6 months))
D: Number of Gout Flares Per Participant Assessed From Day 1 to Day 84 (Week 12) (Day 1 (Baseline) to Day 84 (Week 12))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-Center, Randomized, Double-Blind Phase II Study Comparing Cediranib (AZD2171) Plus Gefitinib (Iressa, ZD1839) With Cediranib Plus Placebo in Subjects With Recurrent/Progressive Glioblastoma (DORIC Trial)
Brief Summary: RATIONALE: Cediranib Maleate and gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether cediranib maleate given together with gefitinib is more effective than cediranib maleate given alone in treating patients with recurrent or progressive glioblastoma.

PURPOSE: This randomized phase II trial is studying the side effects of giving cediranib maleate together with gefitinib and to see how well it works compared with giving cediranib maleate together with a placebo in treating patients with recurrent or progressive glioblastoma.


Options:
A: Maximum Tolerated Dose (MTD) DNX-2401 (Assessed during 14 day waiting period between doses (every 28 days).)
B: Progression Free Survival (PFS) time (5 years)
C: Progression-free Survival (from the date of randomisation to the date of first progression or death due to any cause, until 6 months from the date the last patient finished trial treatment (the day after the date that the last trial drug was taken))
D: Overall Survival (at 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-Center, Randomized, Double-Blind Phase II Study Comparing Cediranib (AZD2171) Plus Gefitinib (Iressa, ZD1839) With Cediranib Plus Placebo in Subjects With Recurrent/Progressive Glioblastoma (DORIC Trial)
Brief Summary: RATIONALE: Cediranib Maleate and gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether cediranib maleate given together with gefitinib is more effective than cediranib maleate given alone in treating patients with recurrent or progressive glioblastoma.

PURPOSE: This randomized phase II trial is studying the side effects of giving cediranib maleate together with gefitinib and to see how well it works compared with giving cediranib maleate together with a placebo in treating patients with recurrent or progressive glioblastoma.


Options:
A: Percentage of Participants Alive 6 Months After Start of Treatment (6 months); Overall Survival (OS) (Baseline until death (up to 691 days))
B: 1. Percentage of patients with a histologically confirmed malignant glioma (grade III or IV -WHO) without definite residual contrast agent-accumulating tumour in the early post-operative control MRI (within 72 hours of the operation). (Within 72 hours after surgery); 2. Progression-free survival 6 months after primary surgical treatment of a malignant gli-oma in patients with histologically confirmed malignant glioma (grade III or IV -WHO). (Within 6 month after surgery)
C: Progression-free Survival (from the date of randomisation to the date of first progression or death due to any cause, until 6 months from the date the last patient finished trial treatment (the day after the date that the last trial drug was taken))
D: Overall Survival (2.5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-Center, Randomized, Double-Blind Phase II Study Comparing Cediranib (AZD2171) Plus Gefitinib (Iressa, ZD1839) With Cediranib Plus Placebo in Subjects With Recurrent/Progressive Glioblastoma (DORIC Trial)
Brief Summary: RATIONALE: Cediranib Maleate and gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether cediranib maleate given together with gefitinib is more effective than cediranib maleate given alone in treating patients with recurrent or progressive glioblastoma.

PURPOSE: This randomized phase II trial is studying the side effects of giving cediranib maleate together with gefitinib and to see how well it works compared with giving cediranib maleate together with a placebo in treating patients with recurrent or progressive glioblastoma.


Options:
A: Progression-free Survival (from the date of randomisation to the date of first progression or death due to any cause, until 6 months from the date the last patient finished trial treatment (the day after the date that the last trial drug was taken))
B: Progression-Free Survival (PFS) (Randomization until progressive disease (PD) or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks))
C: Progression free survival (12 months)
D: Overall Survival (OS) (From randomization to date of death or last follow-up. Analysis occurs after all 390 deaths have been reported.); Progression-free Survival (PFS) (From randomization to date of progression, death, or last follow-up for progression-free survival. Analysis occurs after all 390 deaths have been reported.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Double Blind, Randomized, Prospective Trial of Impact of Pain Scores on Intrauterine Lidocaine vs Normal Saline Infusion Before IUD Placement.
Brief Summary: The study hypothesis is that infusion of 2% lidocaine at the time of IUD placement will reduce pain scores related to that procedure. In a double blinded randomized trial of 60 women receiving either normal saline or lidocaine infused through an endometrial aspirator, pain scores will be obtained for each step of the IUD placement procedure and for the total experience.


Options:
A: Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale (VAS) (Immediately post IUD insertion)
B: Mean Pain Score During IUD Insertion (Day 1)
C: Pain Scores During Overall IUD Placement (Before patient left the examination room at conclusion of procedure); Pain During Tenaculum Placement (Immediately following tenaculum placement); Pain Measurement During Liquid Infusion/Sounding (Recorded at the end of the infusion); Pain During IUD Placement (Immediately after IUD placement)
D: The primary outcome measure is worst perceived pain during the IUD insertion procedure, on a 100 mm visual analogue scale (after IUD insertion)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Using Group Commitment for Smoking Cessation
Brief Summary: This study proposes a novel behavioral intervention to help smokers in Thailand to achieve their goals of quitting. Smoking treatment programs are rare throughout most of Asia and unlikely to meet the impending demand for quitting that tobacco control regulations is stimulating. New approaches are needed.

The present study is a randomized controlled trial to test the effectiveness of a novel, scalable approach to smoking cessation that is targeted toward rural Southeast Asian communities. Thailand is used as a test case to explore if pairs of smokers quit successfully after making financially-backed commitments and receiving cash incentives to quit. The control group receives education and counseling about quitting. In addition to education and counseling about quitting, the intervention includes two key components:

1. Each participant is encouraged to deposit his "cigarette money" on a weekly basis, to be returned only if the smoker quits successfully within three months. Such commitment contracts, based on theory from behavioral economics, are designed to help a person to maintain self-control and motivation in the face of temptation.
2. Each participant is paired with another study participant. If both quit, each receives a cash bonus. The joint incentives are designed to lead partners to support each other throughout the quit attempt.

Thus, group commitment contracts marshal a robust blend of elements: financial commitment, social support, peer pressure, and monetary rewards. A larger, follow-up evaluation will clarify the relative importance of each of these elements.


Options:
A: smoking quit rate change from baseline at 3-month follow-up (3-month follow-up); smoking quit rate change from baseline at 6-month follow-up (6-month follow-up)
B: Urinary Cotinine (Change from baseline: weekly in treatment phase 1; between 0 to 16 times during treatment phase 2 (non-responders meet 16 times; responders meet 0 or 6 times depending on group); Follow-up interviews (Post-phase 1, Post-phase 2, 6-months and 12-months)); Longest Duration of Continuous Abstinence (Change from baseline: Weekly through treatment phase 1; between 0 to 16 times during treatment phase 2 (non-responders meet 16 times; responders meet 0 or 6 times depending on group)); Seven-Day Point-Prevalence (Follow-up interviews: Post-phase 1, Post-phase 2, 6-months and 12-months after treatment initiation.); Carbon Monoxide Results (Change from baseline: weekly in treatment phase 1; between 0 to 16 times during treatment phase 2 (non-responders meet 16 times; responders meet 0 or 6 times depending on group); Follow-up interviews (Post-phase 1, Post-phase 2, 6-months and 12-months))
C: Biochemical verification of smoking status. (15 months)
D: Smoking Status at 6 Months (6 months after enrollment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Using Group Commitment for Smoking Cessation
Brief Summary: This study proposes a novel behavioral intervention to help smokers in Thailand to achieve their goals of quitting. Smoking treatment programs are rare throughout most of Asia and unlikely to meet the impending demand for quitting that tobacco control regulations is stimulating. New approaches are needed.

The present study is a randomized controlled trial to test the effectiveness of a novel, scalable approach to smoking cessation that is targeted toward rural Southeast Asian communities. Thailand is used as a test case to explore if pairs of smokers quit successfully after making financially-backed commitments and receiving cash incentives to quit. The control group receives education and counseling about quitting. In addition to education and counseling about quitting, the intervention includes two key components:

1. Each participant is encouraged to deposit his "cigarette money" on a weekly basis, to be returned only if the smoker quits successfully within three months. Such commitment contracts, based on theory from behavioral economics, are designed to help a person to maintain self-control and motivation in the face of temptation.
2. Each participant is paired with another study participant. If both quit, each receives a cash bonus. The joint incentives are designed to lead partners to support each other throughout the quit attempt.

Thus, group commitment contracts marshal a robust blend of elements: financial commitment, social support, peer pressure, and monetary rewards. A larger, follow-up evaluation will clarify the relative importance of each of these elements.


Options:
A: Salivary cotinine or anabasine testing (metabolites of nicotine) (at 6 months following the patient selected target quit date.)
B: Smoking Behavior (Self-report Confirmed by Expired Breath CO) (8 week follow up); Urinary Cotinine (8 week follow-up)
C: Smoking Status at 6 Months (6 months after enrollment)
D: Continuous smoking abstinence since target quit date until last visit before delivery. (Last 6 months of pregnancy)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Simplified Tai Chi for Reducing Fibromyalgia Pain
Brief Summary: Data from two recent Tai chi studies have found that Tai Chi yields symptomatic benefit in patients with fibromyalgia (FM). The purpose of this study is to confirm those findings in a larger randomized, controlled clinical trial in a community-based setting. We also sought to extend this line of inquiry by closely examining Tai chi's effect on physical function, specifically postural stability. Towards these ends, we conducted a single-blind, randomized controlled clinical trial of an FM modified 8-form Yang-style Tai chi program compared to standard education. Subjects in both conditions meet in small groups two times weekly for 60 minutes over 12 weeks.


Options:
A: The primary outcome measure will be the change in mean daily pain diary score from baseline (average pain score over 7 days pre-treatment) to the final week of Qigong treatment. (7 days)
B: Fibromyalgia Impact Questionnaire (Assessed following 12 week intervention)
C: Ambulatory Pain (Higher Values Indicate Greater Pain) (Baseline and after 12-weeks); Ambulatory Fatigue, Higher Values Indicate Greater Fatigue (Baseline and after 12-weeks)
D: Visual Analog Scale for Pain (baseline, after 16 weeks and after 32 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Simplified Tai Chi for Reducing Fibromyalgia Pain
Brief Summary: Data from two recent Tai chi studies have found that Tai Chi yields symptomatic benefit in patients with fibromyalgia (FM). The purpose of this study is to confirm those findings in a larger randomized, controlled clinical trial in a community-based setting. We also sought to extend this line of inquiry by closely examining Tai chi's effect on physical function, specifically postural stability. Towards these ends, we conducted a single-blind, randomized controlled clinical trial of an FM modified 8-form Yang-style Tai chi program compared to standard education. Subjects in both conditions meet in small groups two times weekly for 60 minutes over 12 weeks.


Options:
A: pain; disability; fatigue; psychological distress at post treatment and 6 month follow-up
B: Pain (10 sessions, in 5 weeks, 2 times a week)
C: Pain severity (Week 3)
D: Fibromyalgia Impact Questionnaire (Assessed following 12 week intervention)

Answer: D