TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Blinded, Double Dummy, Multi-center, Placebo Controlled, 3 Period, Crossover Study to Assess the Effect of QVA149 (110/50 µg o.d.) on Exercise Endurance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Tiotropium as an Active Control.
Brief Summary: This study assessed the effect of once-daily indacaterol and glycopyrronium bromide (QVA149) on exercise endurance in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).


Options:
A: First Occurrence of (Moderate or Severe) COPD Exacerbation (52 weeks)
B: Change From Baseline in Clinic Visit Trough Forced Expiratory Volume in One Second (FEV1) at Day 169 (Baseline and Day 169)
C: Exercise Tolerance Comparison Between QVA149 and Placebo Groups (3 weeks)
D: Rate of COPD Exacerbations (52 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Blinded, Double Dummy, Multi-center, Placebo Controlled, 3 Period, Crossover Study to Assess the Effect of QVA149 (110/50 µg o.d.) on Exercise Endurance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Tiotropium as an Active Control.
Brief Summary: This study assessed the effect of once-daily indacaterol and glycopyrronium bromide (QVA149) on exercise endurance in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).


Options:
A: Exercise Tolerance Comparison Between QVA149 and Placebo Groups (3 weeks)
B: Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 (Week 26)
C: FEV1 AUC0-24 on Day 29 (Day 29)
D: Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) After 12 Weeks (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised-controlled Trial of Switching to Alternative Tumour-necrosis Factor (TNF)-Blocking Drugs or Abatacept or Rituximab in Patients With Rheumatoid Arthritis Who Have Failed an Initial TNF-blocking Drug
Brief Summary: The principal aim of this study is to fill a clear knowledge gap and provide guidance for rheumatologists and reassurance to the patient group on a management challenge faced daily in rheumatology practice. Specifically, it aims to provide robust evidence on the optimal management of patients with established RA that have failed an anti-TNF therapy (the first of the biological therapies to be introduced); in particular, the investigators wish to address whether the currently licensed but non NICE-approved treatment options, TNF-blocking drug or abatacept, are equivalent to the NICE-approved treatment, rituximab. If so, the intention is to broaden treatment options and target these specific therapies to disease sub-groups.


Options:
A: Percentage of Subjects Without Baseline Protective Titers Achieving a ≥ 2-fold Titer Increase in ≥ 3 of 6 Pneumococcal Antigens (6B, 9V, 14, 18C, 19F, and 23F) at Week 6. (Baseline, End of single blind period (Week 6)); Percentage of Subjects Without Baseline Protective Titers Achieving a ≥ 4-fold Titer Increase in ≥ 2 of 3 Influenza Antigens (2009/2010 Composition) at Week 6. (Baseline, End of single blind period (Week 6))
B: American College of Rheumatology 20% (ACR20) Response at Week 12 (Baseline, Week 12)
C: Change in disease activity. (6 months)
D: To assess the efficacy of CDP870 in combination with Methotrexate in the treatment of Rheumatoid Arthritis and prevention of structural damage by measuring the ACR20 response at week 24 and change from Baseline

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised-controlled Trial of Switching to Alternative Tumour-necrosis Factor (TNF)-Blocking Drugs or Abatacept or Rituximab in Patients With Rheumatoid Arthritis Who Have Failed an Initial TNF-blocking Drug
Brief Summary: The principal aim of this study is to fill a clear knowledge gap and provide guidance for rheumatologists and reassurance to the patient group on a management challenge faced daily in rheumatology practice. Specifically, it aims to provide robust evidence on the optimal management of patients with established RA that have failed an anti-TNF therapy (the first of the biological therapies to be introduced); in particular, the investigators wish to address whether the currently licensed but non NICE-approved treatment options, TNF-blocking drug or abatacept, are equivalent to the NICE-approved treatment, rituximab. If so, the intention is to broaden treatment options and target these specific therapies to disease sub-groups.


Options:
A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 (Month 6); Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3 (Baseline, Month 3); Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6 (Month 6)
B: Double-blind Withdrawal (DBW) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Antibody Responses by Enzyme-Linked Immunosorbent Assay (ELISA) at Day 169 (Day 169); Re-introduction (RI) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA at Day 253, by DBW Period Groups (Day 253 (short term))
C: Percentage of ACR20 (American College of Rheumatology 20% Improvement) Responders at Week 34 in Patients Randomized at Week 18 (Baseline, Week 34)
D: Change in disease activity. (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised-controlled Trial of Switching to Alternative Tumour-necrosis Factor (TNF)-Blocking Drugs or Abatacept or Rituximab in Patients With Rheumatoid Arthritis Who Have Failed an Initial TNF-blocking Drug
Brief Summary: The principal aim of this study is to fill a clear knowledge gap and provide guidance for rheumatologists and reassurance to the patient group on a management challenge faced daily in rheumatology practice. Specifically, it aims to provide robust evidence on the optimal management of patients with established RA that have failed an anti-TNF therapy (the first of the biological therapies to be introduced); in particular, the investigators wish to address whether the currently licensed but non NICE-approved treatment options, TNF-blocking drug or abatacept, are equivalent to the NICE-approved treatment, rituximab. If so, the intention is to broaden treatment options and target these specific therapies to disease sub-groups.


Options:
A: The Number of Participants Achieving Remission As Measured by a Disease Activity Score for 28 Joints (DAS 28) < 2.6. (12 months); Year 1 Participants Having an Annualized Modified Total Sharp Score (mTSS) < 0.5. (12 months)
B: Percentage of Participants With American College of Rheumatology-ACR20 Response (Baseline, Week 24); Change From Baseline in Modified Total Sharp-Genant Score at Week 52 (Baseline, Week 52); Change in Physical Function as Measured by the Area Under the Curve (AUC) for the Change From Baseline in the Health Assessment Questionnaire (HAQ) Disability Index at Week 52 (Baseline to Week 52); Change From Baseline in the Modified Total Sharp-Genant Score at Week 104 (Baseline, Week 104); Change in Physical Function as Measured by the Area Under the Curve for the Change From Baseline in the Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 104 (Baseline to Week 104)
C: Change in disease activity. (6 months)
D: Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response at Week 24 (Week 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised-controlled Trial of Switching to Alternative Tumour-necrosis Factor (TNF)-Blocking Drugs or Abatacept or Rituximab in Patients With Rheumatoid Arthritis Who Have Failed an Initial TNF-blocking Drug
Brief Summary: The principal aim of this study is to fill a clear knowledge gap and provide guidance for rheumatologists and reassurance to the patient group on a management challenge faced daily in rheumatology practice. Specifically, it aims to provide robust evidence on the optimal management of patients with established RA that have failed an anti-TNF therapy (the first of the biological therapies to be introduced); in particular, the investigators wish to address whether the currently licensed but non NICE-approved treatment options, TNF-blocking drug or abatacept, are equivalent to the NICE-approved treatment, rituximab. If so, the intention is to broaden treatment options and target these specific therapies to disease sub-groups.


Options:
A: Change From Baseline to Week 24 in the Disease Activity Score 28 (DAS28) (Baseline to Week 24)
B: Change in disease activity. (6 months)
C: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 (Month 6); Changes From Baseline in Modified Total Sharp Score (mTSS) at Month 6 (Baseline, Month 6); Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 (Baseline, Month 3); Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6 (Month 6)
D: Proportion of subjects achieving a good or moderate DAS28 response (as defined by the EULAR28 response criteria) at Week 12

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Internet-based Physical Activity Intervention
Brief Summary: The purpose of this study is to determine whether access to a website with personalized feedback on physical activity level and suggestions to increase physical activity results in improvements in self-reported physical activity, anthropometrics and physiological measurements


Options:
A: Time spent being physically active (2 months); Time spent sitting (2 months); Changes in food consumption (2 months)
B: Number of myPAtHS exercise sessions. (12 weeks & 24 weeks); Time spent doing the myPAtHS exercise programme. (12 weeks & 24 weeks)
C: Change in Hours of Sitting Time (12 weeks)
D: Self reported physical activity (after 3 month); Self reported physical activity (After 6 month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Sugar Sweetened Beverages And Cardiovascular Disease Risk
Brief Summary: The overall aim of the study is to compare the effects of three types of beverages - sugar-sweetened (SSB), artificially sweetened (ASB), and unsweetened (USB) - on cardiovascular disease (CVD) risk factors and body weight among young adults.


Options:
A: Dietary intake (6 month)
B: Change in body weight from baseline (4 weeks)
C: Cardiovascular Disease Prevention based on dietary approach. (Two years)
D: Ratio of Serum Triglyceride to HDL-cholesterol Concentration (TG:HDLC) (12 Month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Investigator Initiated, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Humira® (Adalimumab) For The Treatment of Interstitial Cystitis(IC)
Brief Summary: The purpose of this study is to evaluate an investigational treatment for interstitial cystitis. Interstitial cystitis is a chronic bladder disease that includes the following symptoms: Urinary frequency during the day,urinary frequency at night, urinary urgency and bladder discomfort relieved by voiding.

Presently, there is no cure for interstitial cystitis. The response to current treatments is poor. Patients with interstitial cystitis have a poorer quality of life. The cause of interstitial cystitis is unknown. This study is evaluating the drug Humira® (adalimumab) for improving the symptoms of patients with interstitial cystitis. Humira® is an injectable anti-inflammatory medication that has been available for use since December 31, 2002. Humira® has been FDA approved for the treatment of rheumatoid arthritis, psoriasis, ankylosing spondylitis, and Crohn's disease. These diseases have similar characteristics to interstitial cystitis. This study will evaluate an investigational use of Humira® for the treatment of interstitial cystitis.


Options:
A: Change From Baseline in Mean Average Daily Pain Score at Week 8 (Baseline, Week 8)
B: Change From Baseline in Treatment Response as Measured by the Total Score on the O'Leary-Sant Questionnaire (Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported)
C: Proportion of responders moderately or markedly improved on a 7-point global response assessment (GRA) scale (12 Weeks)
D: O'Leary-Santa Interstitial Cystitis Symptom Index and Problem Index (OSPI) Score (Baseline/12 Weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Perioperative Effect of Corticosteroid Prophylaxis on the Cardiopulmonary Bypass-Induced Systemic Inflammatory Response
Brief Summary: To observe the effect of glucocorticoid on the dynamic changes of monocyte subsets in the peripheral blood of valve disease patients undergoing cardiopulmonary bypass perioperatively.


Options:
A: Composite endpoint of mortality, myocardial infarction, stroke, renal failure and prolonged mechanical ventilation (> 48h) (30 days postoperatively)
B: Post operative atrial fibrillation detected on continuous ECG monitoring. (Monitoring will commence soon after surgery and will be continued until the end of post operative day 5); Myocardial injury assessed by Troponin release (Serial blood samples for Troponin assay will be collected at 6, 24, 48 and 120 hours after surgery)
C: recovery of monocyte subsets (baseline, day1, 3, 5, 7 postoperative)
D: Evolution of pro-inflammatory and anti-inflammatory cytokines [TNF-alfa, IL-1, IL-6, IL-8 and IL-10 (1) before induction of anesthesia; 2)at the end of CPB; 3) at the end of surgical procedure; 4) 24 h; 5) 48 h; 6) 5th postoperative day); only for Study group-1 h after start of CPB: 7)from blood entering CytoSorb and 8)from blood leaving CytoSorb); Evolution of complement C5a (1) before induction of anesthesia; 2)at the end of CPB; 3) at the end of surgical procedure; 4) 24 h; 5) 48 h; 6) 5th postoperative day); only for Study group-1 h after start of CPB: 7)from blood entering CytoSorb and 8)from blood leaving CytoSorb); Evolution of CD 64 and CD 163 markers (1) before induction of anesthesia; 2)at the end of CPB; 3) at the end of surgical procedure; 4) 24 h; 5) 48 h; 6) 5th postoperative day); only for Study group-1 h after start of CPB: 7)from blood entering CytoSorb and 8)from blood leaving CytoSorb); Evolution of miRNA (1) before induction of anesthesia; 2)at the end of CPB; 3) at the end of surgical procedure; 4) 24 h; 5) 48 h; 6) 5th postoperative day); only for Study group-1 h after start of CPB: 7)from blood entering CytoSorb and 8)from blood leaving CytoSorb); Evolution of PON1, HDL and LDL (1) before induction of anesthesia; 2)at the end of CPB; 3) at the end of surgical procedure; 4) 24 h; 5) 48 h; 6) 5th postoperative day); only for Study group-1 h after start of CPB: 7)from blood entering CytoSorb and 8)from blood leaving CytoSorb)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: DEMOnstration Area for Primary Prevention of Type 2 Diabetes, JUAN Mina and Barranquilla, Colombia
Brief Summary: The main aim of this study is to investigate to what extent it is possible to reach normal glucose metabolism and optimal cardiovascular disease (CVD) risk factor levels with early lifestyle interventions in people at high risk of type 2 diabetes compared with those who receive standard therapy (usual care) only.

The project will show the effect of these interventions for the first time in people of low socio-economic levels living in a Caribbean environment.


Options:
A: Weight Change From Baseline to 12 Months (12 months)
B: The proportion of patients who reach normal levels of all glycaemic parameters. (Month 24 of the intervention)
C: Cardiovascular mortality (Sept 2010); MI (non fatal) (Sept 2010); Stroke (non fatal) (Sept 2010); Revascularisation (operating procedures) (Sept 2010); Amputations, non traumatic (Sept 2010)
D: To contribute to the ADDITION-Europe study, to assess screening and intensive treatment on 5 year cardiovascular outcomes (At end of study)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Regular Reporting of Spirometric Results Combined With a Smoking Cessation Advice by a Primary Care Physician on Smoking Quit Rate in Adult Smokers: a Randomized Controlled Trial.
Brief Summary: The purpose of this study is to evaluate the effectiveness of regular reporting of spirometric results combined with smoking cessation advice on smoking quit rate in adult smokers in primary care.

Hypothesis: In adult smokers, regular reporting of spirometric test results in addition with smoking cessation advice will increase smoking quit rate.

Expected outcome: increase of smoking cessation rate .


Options:
A: Smoking abstinence as measured by 7-day point prevalence abstinence at 12 months following treatment (12 months)
B: Smoking abstinence: self reported abstinence (12 or more months smoking free. (24 months after last recruitment)
C: Smoking cessation (point prevalence, both self reported as biochemical verified) (12 months)
D: Reduction in number of cigarettes smoked as measured by the Timeline Follow-back. (Baseline, Pre Counseling Sessions 1-5, Weeks 8, 12, 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Regular Reporting of Spirometric Results Combined With a Smoking Cessation Advice by a Primary Care Physician on Smoking Quit Rate in Adult Smokers: a Randomized Controlled Trial.
Brief Summary: The purpose of this study is to evaluate the effectiveness of regular reporting of spirometric results combined with smoking cessation advice on smoking quit rate in adult smokers in primary care.

Hypothesis: In adult smokers, regular reporting of spirometric test results in addition with smoking cessation advice will increase smoking quit rate.

Expected outcome: increase of smoking cessation rate .


Options:
A: Motivation to quit smoking, utilization of available resources, smoking cessation rate (1 year)
B: Smoking abstinence: self reported abstinence (12 or more months smoking free. (24 months after last recruitment)
C: Cessation of tobacco consumption at 12 months. (12 months)
D: Preoperative Carbon Monoxide Levels (the morning of surgery); Exhaled CO Level Measured Immediately Prior to Surgery (The median time from study assessment at POE to surgery was 1 day with an interquartile range of 1 to 3 days.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Tailored Internet-administrated Treatment of Panic Symptoms - A Randomised Controlled Trial
Brief Summary: The purpose of this study is to determine whether tailored internet-administrated CBT is a feasible approach in the treatment of panic symptoms and comorbid anxiety and depressive symptoms.


Options:
A: Leibowitz Social Anxiety Scale - Self Report (LSAS-SR) (pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)); Social Phobia Inventory (SPIN) (pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37))
B: Panic Disorder Severity Scale (PDSS) (Pre, post at 6-month follow-up)
C: Panic Disorder Severity Scale (PDSS) (Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment)
D: Measure of social anxiety and avoidance - Liebowitz Social Anxiety Scale (LSAS) (5-year follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Tailored Internet-administrated Treatment of Panic Symptoms - A Randomised Controlled Trial
Brief Summary: The purpose of this study is to determine whether tailored internet-administrated CBT is a feasible approach in the treatment of panic symptoms and comorbid anxiety and depressive symptoms.


Options:
A: Panic Disorder Severity Scale (PDSS) (Pre, post at 6-month follow-up)
B: Leibowitz Social Anxiety Scale - Self Report (LSAS-SR) (pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)); Social Phobia Inventory (SPIN) (pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37))
C: Health Anxiety Inventory (3 days before treatment start); Health Anxiety Inventory (12 weeks after pre asessment); Health Anxiety Inventory (6 months after post assessment); Health Anxiety Inventory (12 months after post assessment)
D: Panic Disorder Severity Scale (PDSS) (Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Can Exercise Improve Cancer Associated Cognitive Dysfunction?
Brief Summary: Following chemotherapy, some breast cancer survivors report alterations in their ability to remember, concentrate, or think, which can have significant emotional, psychological, and economic impact on their lives. Survivors have also reported feeling frustrated by the response of the medical community, who either may not acknowledge their symptoms or have no treatment options to suggest. Exercise may be a promising treatment, as improvements in cognitive function with exercise have been demonstrated in older adults and other clinical populations.

The investigators will recruit women who have completed chemotherapy for breast cancer (within the past 2 years) and report cognitive changes. Women will be randomly assigned to either a 24-week aerobic exercise intervention or delayed exercise control (offered the same exercise program following the study). At the start and end of the study the investigators will measure: i) performance on four standard neuropsychological tests that measure working memory, learning, and problem solving; ii) a questionnaire on cognitive function and its impact on quality of life; iii) functional magnetic resonance imaging (fMRI) during two of the standard neuropsychological tests which provides information on how the brain is working during the tests.

To knowledge of the investigators this is the first study to examine the effect of an exercise intervention on cognitive function in breast cancer survivors. In addition, the use of fMRI imaging is a new way to approach this research question, and may be more sensitive to change than traditional measures of cognitive function.


Options:
A: Stroop Test (Change from baseline at 6 months)
B: Change from baseline in numbers of goal behaviors at 3 months (Baseline (pre-treatment) and after 12 weeks of intervention (post-treatment))
C: Cardiorespiratory Fitness will be determined using a incremental treadmill test with 12-lead ECG monitoring. (6 months)
D: Specific aim 1: To determine whether there are any changes in lymphedema in breast cancer survivors who participate in a one-year randomized exercise intervention of twice-weekly strength training, as compared to a non-exercising group. (1 year)

Answer: A