TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Short and Long-term Effects of Exercise and Education as Self-management in Women With Fibromyalgia
Brief Summary: The overall objective of this work is to improve treatment outcomes for persons with fibromyalgia by optimizing the approach to self-management. The purpose of this research project is to evaluate and compare, in a randomized, controlled trial involving 200 women, the short and long-term effectiveness of four approaches to fibromyalgia self-management for improving health and functional status, self-efficacy, and symptom severity. Additionally, we will also examine the effect of each intervention on health care usage. We will assess the following 16-week interventions:

* cardiovascular and flexibility exercise
* strength training, cardiovascular and flexibility exercise
* Arthritis Foundation's Fibromyalgia Self-Help course
* a combination of the Fibromyalgia Self-Help Course and strength training exercise interventions


Options:
A: Six-minute Walk Test (15 weeks); Change of Pain Level From Baseline. (15 weeks)
B: Fibromyalgia Impact Questionnaire (Baseline, 16 wks and 10 months)
C: Visual Analog Scale for Pain (baseline, after 16 weeks and after 32 weeks)
D: pain; disability; fatigue; psychological distress at post treatment and 6 month follow-up

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Short and Long-term Effects of Exercise and Education as Self-management in Women With Fibromyalgia
Brief Summary: The overall objective of this work is to improve treatment outcomes for persons with fibromyalgia by optimizing the approach to self-management. The purpose of this research project is to evaluate and compare, in a randomized, controlled trial involving 200 women, the short and long-term effectiveness of four approaches to fibromyalgia self-management for improving health and functional status, self-efficacy, and symptom severity. Additionally, we will also examine the effect of each intervention on health care usage. We will assess the following 16-week interventions:

* cardiovascular and flexibility exercise
* strength training, cardiovascular and flexibility exercise
* Arthritis Foundation's Fibromyalgia Self-Help course
* a combination of the Fibromyalgia Self-Help Course and strength training exercise interventions


Options:
A: Six-minute Walk Test (15 weeks); Change of Pain Level From Baseline. (15 weeks)
B: Fibromyalgia Impact Questionnaire (Baseline, 16 wks and 10 months)
C: Overall impact of fibromyalgia (Participants will be followed over 24 weeks)
D: Ambulatory Pain (Higher Values Indicate Greater Pain) (Baseline and after 12-weeks); Ambulatory Fatigue, Higher Values Indicate Greater Fatigue (Baseline and after 12-weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Short and Long-term Effects of Exercise and Education as Self-management in Women With Fibromyalgia
Brief Summary: The overall objective of this work is to improve treatment outcomes for persons with fibromyalgia by optimizing the approach to self-management. The purpose of this research project is to evaluate and compare, in a randomized, controlled trial involving 200 women, the short and long-term effectiveness of four approaches to fibromyalgia self-management for improving health and functional status, self-efficacy, and symptom severity. Additionally, we will also examine the effect of each intervention on health care usage. We will assess the following 16-week interventions:

* cardiovascular and flexibility exercise
* strength training, cardiovascular and flexibility exercise
* Arthritis Foundation's Fibromyalgia Self-Help course
* a combination of the Fibromyalgia Self-Help Course and strength training exercise interventions


Options:
A: Change in Fibromyalgia Impact Questionnaire (FIQ) from baseline to 24 weeks (Week 0, Week 24)
B: Measure the effects of exercise-based MI intervention improving exercise adherence. (This is a five year study, each subject will participate in a 9-month study sequence)
C: Visual Analog Scale for Pain (baseline, after 16 weeks and after 32 weeks)
D: Fibromyalgia Impact Questionnaire (Baseline, 16 wks and 10 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Short and Long-term Effects of Exercise and Education as Self-management in Women With Fibromyalgia
Brief Summary: The overall objective of this work is to improve treatment outcomes for persons with fibromyalgia by optimizing the approach to self-management. The purpose of this research project is to evaluate and compare, in a randomized, controlled trial involving 200 women, the short and long-term effectiveness of four approaches to fibromyalgia self-management for improving health and functional status, self-efficacy, and symptom severity. Additionally, we will also examine the effect of each intervention on health care usage. We will assess the following 16-week interventions:

* cardiovascular and flexibility exercise
* strength training, cardiovascular and flexibility exercise
* Arthritis Foundation's Fibromyalgia Self-Help course
* a combination of the Fibromyalgia Self-Help Course and strength training exercise interventions


Options:
A: Mean Change From Baseline of Fibromyalgia Impact Questionnaire Score (wks 12)
B: Decrease of pain and use of specific medicine for fibromyalgia (16 weeks)
C: Fibromyalgia Impact Questionnaire (Baseline, 16 wks and 10 months)
D: Six-minute Walk Test (15 weeks); Change of Pain Level From Baseline. (15 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Short and Long-term Effects of Exercise and Education as Self-management in Women With Fibromyalgia
Brief Summary: The overall objective of this work is to improve treatment outcomes for persons with fibromyalgia by optimizing the approach to self-management. The purpose of this research project is to evaluate and compare, in a randomized, controlled trial involving 200 women, the short and long-term effectiveness of four approaches to fibromyalgia self-management for improving health and functional status, self-efficacy, and symptom severity. Additionally, we will also examine the effect of each intervention on health care usage. We will assess the following 16-week interventions:

* cardiovascular and flexibility exercise
* strength training, cardiovascular and flexibility exercise
* Arthritis Foundation's Fibromyalgia Self-Help course
* a combination of the Fibromyalgia Self-Help Course and strength training exercise interventions


Options:
A: Decrease of pain and use of specific medicine for fibromyalgia (16 weeks)
B: Fibromyalgia Impact Questionnaire (Baseline, 16 wks and 10 months)
C: Six-minute Walk Test (15 weeks); Change of Pain Level From Baseline. (15 weeks)
D: Change in Fibromyalgia Impact Questionnaire (FIQ) from baseline to 24 weeks (Week 0, Week 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter Randomized, Double-Blind, Controlled Study of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy
Brief Summary: The purpose of the study was to assess the efficacy and safety of NGX-4010 applied for 30 or 60 minutes for the treatment of painful HIV-associated neuropathy.


Options:
A: Pain change capsaicin vs. placebo patch treatment (Pain intensity assessed at baseline and at 1,2,3 months follow-up)
B: Endpoint mean pain score derived from the subject's daily pain diary (Endpoint); Patient Global Assessment (Patient Global Impression of Change) at Termination Visit (Weeks 5 and 13); Change from baseline in functioning (score created from the Short Form-36 [SF-36] Social and Physical Functioning, Fibromyalgia Impact Questionnaire [FIQ]-Total Score, and Sheehan Disability Scale [SDS] Total Score) at Termination Visit (Baseline and Weeks 5, 9, and 13)
C: The Primary Measure of Efficacy Was the Percent Change in the "Average Pain for the Past 24 Hours" Numeric Pain Rating Scale (NPRS) Score From Baseline During Weeks 2 to 12. (Weeks 2-12)
D: Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 8 (Baseline to between Weeks 2 to 8)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of Romiplostim (AMG 531) Treatment of Subjects With Low or Intermediate Risk Myelodysplastic Syndrome (MDS) Receiving Hypomethylating Agents
Brief Summary: The purpose of this study is to evaluate the effect of Romiplostim (AMG 531) on the incidence of clinically significant thrombocytopenic events (grade 3 or 4 and/or receipt of platelet transfusions) in subjects with low or intermediate risk Myelodysplastic Syndrome (MDS) receiving hypomethylating agents. It is hypothesized that Romiplostim administration, at the appropriate dose and schedule, will result in reduction in the incidence of clinically significant thrombocytopenic events in low or intermediate risk MDS subjects receiving hypomethylating agents.


Options:
A: Safety and tolerability parameters (week 26)
B: Occurrence of a Clinically Significant Thrombocytopenic Event (Treatment period (up to 20 weeks))
C: The Portion of Drug Responders as Defined by Hematologic Improvements (12-16 weeks)
D: Part A: Number of Participants With Adverse Events (Treatment period (4 weeks) plus treatment extension (1 year)); Part B: Number of Participants With Adverse Events (Treatment period (8 weeks) plus treatment extension (1 year))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of Romiplostim (AMG 531) Treatment of Subjects With Low or Intermediate Risk Myelodysplastic Syndrome (MDS) Receiving Hypomethylating Agents
Brief Summary: The purpose of this study is to evaluate the effect of Romiplostim (AMG 531) on the incidence of clinically significant thrombocytopenic events (grade 3 or 4 and/or receipt of platelet transfusions) in subjects with low or intermediate risk Myelodysplastic Syndrome (MDS) receiving hypomethylating agents. It is hypothesized that Romiplostim administration, at the appropriate dose and schedule, will result in reduction in the incidence of clinically significant thrombocytopenic events in low or intermediate risk MDS subjects receiving hypomethylating agents.


Options:
A: Occurrence of a Clinically Significant Thrombocytopenic Event (Treatment period (up to 20 weeks))
B: How Many WAS Patients Will Achieve Platelet Counts Above 50,000/ul. (12 weeks)
C: reduction in numbers of platelet transfusion by 25 % in the experimental arm (therapeutic transfusion strategy)compared with the standard arm (prophylactic transfusion strategy) (2010)
D: Evaluate the relative bioavailability of a PfOS formulation relative to the commercial eltrombopag 25 mg tablet formulation in healthy adult subjects. (72 hours x 2 periods); Evaluate the effect of a high calcium, moderate fat and calorie meal on the pharmacokinetics of a single oral 25 mg dose of eltrombopag PfOS in healthy adult subjects when eltrombopag is administered concurrently, two hours before, or two hours afte (72 hours x 3 periods)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of Romiplostim (AMG 531) Treatment of Subjects With Low or Intermediate Risk Myelodysplastic Syndrome (MDS) Receiving Hypomethylating Agents
Brief Summary: The purpose of this study is to evaluate the effect of Romiplostim (AMG 531) on the incidence of clinically significant thrombocytopenic events (grade 3 or 4 and/or receipt of platelet transfusions) in subjects with low or intermediate risk Myelodysplastic Syndrome (MDS) receiving hypomethylating agents. It is hypothesized that Romiplostim administration, at the appropriate dose and schedule, will result in reduction in the incidence of clinically significant thrombocytopenic events in low or intermediate risk MDS subjects receiving hypomethylating agents.


Options:
A: Occurrence of a Clinically Significant Thrombocytopenic Event (Treatment period (up to 20 weeks))
B: Kaplan-Meier Estimates for Median Time to Death From Any Cause (Day 1 (randomization) to 42 months); Summary of Subgroup Analyses for Kaplan-Meier Estimates for Time to Death From Any Cause (Day 1 (randomization) to 42 months); Number of Participants Who Died (42 months)
C: Part A: Number of Participants With Adverse Events (Treatment period (4 weeks) plus treatment extension (1 year)); Part B: Number of Participants With Adverse Events (Treatment period (8 weeks) plus treatment extension (1 year))
D: Occurrence of a Clinically Significant Thrombocytopenic Event (Treatment period through interim follow-up visit (up to 16 weeks))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Patient-Spouse Intervention for Self-Managing High Cholesterol
Brief Summary: We examined the effect of a patient-spouse intervention to lower LDL-C by increasing patient treatment adherence. A randomized controlled trial compared a one-year, telephone-based patient-spouse intervention to usual care. The primary outcome was LDL-C measured three times (baseline, 6 months, 11 months); secondary outcomes were adherence to medication, diet, and exercise, also assessed at baseline, 6 months, and 11 months.


Options:
A: body weight
B: Framingham Risk Score (15 months)
C: Body Mass Index (Baseline, 3-, 6- and 15- month follow-up)
D: Low-density Lipoprotein Cholesterol (11-month follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase 2 Trial Of Erlotinib With Or Without PF-3512676 For The Treatment Of Patients With Advanced EGFR-Positive Non-Small Cell Lung Cancer After Failure Of At Least One Prior Chemotherapy Regimen
Brief Summary: To assess the efficacy and safety of PF-3512676 administered in combination with erlotinib in patients with advanced EGFR-positive non-small cell lung cancer after failure of at least one prior chemotherapy regimen.


Options:
A: Number of Patients Reporting Confirmed Non-small-cell Lung Cancer (NSCLC) Recurrence (Over a median follow-up time of 28 months post-Dose 1)
B: Overall Survival (OS) Time (From the date of randomization until death, assessed up to 5.6 years)
C: Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs (Day 1 to 70 days following last dose of study drug up to June 2013, approximately 4 years); Number of Participants With Abnormal Serum Chemistry Laboratory Values (Day 1 up to June 2013, approximately 4 years); Number of Participants With Abnormal Hematology Laboratory Values (Day 1 up to June 2013, approximately 4 years)
D: Progression-Free Survival (50Events)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Examine the Efficacy and Safety of Early Pramipexole (PPX) Treatment Versus Delayed Pramipexole Treatment in Patients With New Onset Parkinson's Disease.
Brief Summary: This is a double blind, placebo-controlled clinical trial of 15 months duration designed to examine early Mirapex (pramipexole) treatment vs. delayed Mirapex (pramipexole) treatment in patients with new onset Parkinsons disease


Options:
A: Time "on" defined by tapping speed
B: Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline (12w, 24w, 36w, 42w, 48w, 54w, 60w, 66w, 72w)
C: UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment (6 months)
D: Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15 (Baseline and Month 15)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Porcine-Derived Small Intestine Submucosa Graft-Augmented Rectocele Repair-A Randomized Trial
Brief Summary: The purpose of this study is to determine whether adding a graft during a rectocele repair will improve the success rate of the repair.


Options:
A: Does Avaulta Plus reduce the recurrence rate defined as a POP-Q Aa <-2 cm at follow-up after 1 yr. (one year)
B: Anatomic cure defined by standardized POPQ measures (12 months)
C: Recurrence of anterior vaginal wall prolapse
D: Prolapse by "Pelvic Organ Prolapse Quantification System" (POP-Q), at 12 Months (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-label Study of the Effect of NeoRecormon on Reduction of Cardiovascular Risk in Patients With Chronic Renal Anemia Who Are Not on Renal Replacement Therapy.
Brief Summary: This study will evaluate whether anemia prevention with NeoRecormon has an additional impact on reducing cardiovascular risk over conventional anemia treatment in patients mostly with stage IV chronic kidney disease and renal anemia. The anticipated time on study treatment is 2+ years and the target sample size is 500+ individuals.


Options:
A: Change From Baseline in Left Ventricle Mass Index (LVMI) at Month 15 (Baseline, Month 15)
B: Median Time to First Cardiovascular Event (Up to 4 years)
C: Hemoglobin level
D: Time to All-cause Mortality or Cardiovascular (CV) Events Including Hospitalization Due to Acute Myocardial Ischemia, Congestive Heart Failure (CHF), Myocardial Infarction (MI), and Cerebrovascular Accident (CVA) (Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first); Time to All-cause Mortality or End Stage Renal Disease (ESRD) (Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-label Study of the Effect of NeoRecormon on Reduction of Cardiovascular Risk in Patients With Chronic Renal Anemia Who Are Not on Renal Replacement Therapy.
Brief Summary: This study will evaluate whether anemia prevention with NeoRecormon has an additional impact on reducing cardiovascular risk over conventional anemia treatment in patients mostly with stage IV chronic kidney disease and renal anemia. The anticipated time on study treatment is 2+ years and the target sample size is 500+ individuals.


Options:
A: Percent change in left ventricular volume index (LVVI) at Week 96.
B: Median Time to First Cardiovascular Event (Up to 4 years)
C: Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen (From Baseline (Day -28 to Day 1) to EOIT (Week 19 or Week 21))
D: Time to All Cause Death or First Hospitalization for Worsening Heart Failure (From randomization to the end of study; maximum time on study was 73 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-label Study of the Effect of NeoRecormon on Reduction of Cardiovascular Risk in Patients With Chronic Renal Anemia Who Are Not on Renal Replacement Therapy.
Brief Summary: This study will evaluate whether anemia prevention with NeoRecormon has an additional impact on reducing cardiovascular risk over conventional anemia treatment in patients mostly with stage IV chronic kidney disease and renal anemia. The anticipated time on study treatment is 2+ years and the target sample size is 500+ individuals.


Options:
A: Median Time to First Cardiovascular Event (Up to 4 years)
B: Change in hemoglobin (Hb) from baseline to the end of the study; Primarily interested in the change in Hb between Q2W vs Q4W groups. Protocol Addendum: Hb change from baseline to end of open-label extension (no more than 36 weeks)
C: Change in Hb Concentration (g/dL) From Baseline to the Average of the Last 8 Weeks of Treatment Through Week 22 (From baseline through Week 22)
D: The primary outcome will be a composite consisting of mortality (all cause), myocardial infarction, stroke, and CHF hospitalization (not including those hospitalizations during which RRT occurs)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-label Study of the Effect of NeoRecormon on Reduction of Cardiovascular Risk in Patients With Chronic Renal Anemia Who Are Not on Renal Replacement Therapy.
Brief Summary: This study will evaluate whether anemia prevention with NeoRecormon has an additional impact on reducing cardiovascular risk over conventional anemia treatment in patients mostly with stage IV chronic kidney disease and renal anemia. The anticipated time on study treatment is 2+ years and the target sample size is 500+ individuals.


Options:
A: Percentage of Participants Who Maintained Their Mean Hemoglobin Concentration Within +/- 1.0 Gram/Deciliter of Their Reference Hemoglobin Concentration and Between 10.0 and 12.0 Gram/Deciliter During the Efficacy Evaluation Period (EEP (Week 16 to Week 24))
B: Median Time to First Cardiovascular Event (Up to 4 years)
C: Percentage of Participants Maintaining Average Hemoglobin Concentration Within +\- 1 Gram/Deciliter of Their Reference Hb and Between 10.5 and 12.5 Gram/Deciliter During EEP (EEP (Week 16 to Week 24))
D: The Percentage of Participants Maintaining Average Haemoglobin (Hb) Concentration During the Efficacy Evaluation Period (EEP) Within the Target Range (Weeks 16-28)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-label Study of the Effect of NeoRecormon on Reduction of Cardiovascular Risk in Patients With Chronic Renal Anemia Who Are Not on Renal Replacement Therapy.
Brief Summary: This study will evaluate whether anemia prevention with NeoRecormon has an additional impact on reducing cardiovascular risk over conventional anemia treatment in patients mostly with stage IV chronic kidney disease and renal anemia. The anticipated time on study treatment is 2+ years and the target sample size is 500+ individuals.


Options:
A: Mean Change in Hemoglobin Between Baseline and the Evaluation Period (Baseline to Weeks 29-36)
B: Local pain due to s.c. injection (by VAS). (After each injection)
C: Median Time to First Cardiovascular Event (Up to 4 years)
D: Percentage of Participants With Lesser Than or Equal to One Gram Per Deciliter Decrease in Average Hemoglobin From Baseline and Maintaining Average Hemoglobin Level Greater Than or Equal to 10.5 g/dL Over Evaluation Period (Baseline (Week -4 to Week -1) and Evaluation period (Weeks 50 to 53))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial of Early Physical and Occupational Therapy in Mechanically Ventilated, Critically Ill Patients
Brief Summary: To study all ICU patients with an independent baseline functional status, who experience a critical illness requiring intubation and mechanical ventilation, evaluating the role of protocol-directed, early physical and occupational therapy on the incidence of critical illness associated functional debilitation. Our goal is to hasten the recovery of independent physical functioning as well as to reduce ICU delirium in the group of patients who begin this intervention from the earliest hours of ventilator dependence.


Options:
A: Time from the commencement of treatment to extubation (days)
B: delirium- and coma-free days (within the first 14 days after randomisation)
C: Delirium (Daily)
D: Number of patients returning to independent functional status: defined as ability to perform 6 activities of daily living (ADL's)(bathing, dressing, eating, grooming, transfer from bed to chair, toileting) and independent ambulation (Hospital Discharge)

Answer: D