TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Statin Therapy In Cardiac Surgery
Brief Summary: The purpose of STICS trial (Statin Therapy In Cardiac Surgery) is to test whether perioperative treatment with Rosuvastatin 20 mg once daily prevents post-operative atrial fibrillation and reduces perioperative irreversible myocardial damage in patients undergoing elective cardiac surgery.


Options:
A: SOFA Score (24 hours before until day 9 post-surgery)
B: Reduction of systemic inflammatory response (Through study completion, an average of 1 year)
C: Composite endpoint of mortality, myocardial infarction, stroke, renal failure and prolonged mechanical ventilation (> 48h) (30 days postoperatively)
D: 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)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Statin Therapy In Cardiac Surgery
Brief Summary: The purpose of STICS trial (Statin Therapy In Cardiac Surgery) is to test whether perioperative treatment with Rosuvastatin 20 mg once daily prevents post-operative atrial fibrillation and reduces perioperative irreversible myocardial damage in patients undergoing elective cardiac surgery.


Options:
A: 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)
B: troponin (within the first 7 days after surgery); ejection fraction (within two years)
C: to evaluate whether 2 years of treatment with 40 mg rosuvastatin results in regression of coronary artery atheroma burden via the total atheroma volume in the most diseased segment or the percent atheroma volume, as measured by IVUS
D: The primary objective of this study is to determine whether rosuvastatin reduces the combined endpoint of cardiovascular death or non-fatal myocardial infarction (MI) or non-fatal stroke (time to first event).

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: PREvention of VENous Thromboembolism In Hemorrhagic Stroke Patients
Brief Summary: Patients with cerebral hemorrhage (ICH) have a high risk of venous thromboembolism. Intermittent pneumatic compression combined with elastic stockings have been shown to be superior to elastic stockings alone in reducing the rate of asymptomatic deep vein thrombosis after ICH in a randomized trial (4.7% vs. 15.9%). Graduated compression stockings alone are ineffective in preventing deep vein thrombosis in patients with ischemic or hemorrhagic stroke. Less clear is the role of anticoagulation in the prevention of venous thromboembolism in patients with ICH because the use of anticoagulants may cause an enlargement of the hematoma. In a multicenter, randomized trial, the investigators will assess the efficacy and safety of enoxaparin in the prevention of venous thromboembolism in patients with spontaneous intracerebral hemorrhage. Enoxaparin (40 mg once daily) or standard therapy (graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization) will be given subcutaneously for not less than 10 days beginning after 72 hours from stroke onset.


Options:
A: Number of Participants With Symptomatic and Asymptomatic Venous Thromboembolism (10 days)
B: Composite of all fatal or non-fatal major cardiovascular/cerebrovascular ischaemic or haemorrhagic intracranial/extracranial events (within 24 months after randomization.)
C: Recurrent Stroke (Average of 6 years)
D: Number of Participants With a Composite Endpoint of Stroke and Systemic Embolic Events (SEE) in Participants Who Were Administered DU-176b Compared With Placebo (Randomization up to the time of onset of the initial composite event of stroke or systemic embolic event, or study discontinuation, or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time)); Number of Participants With Stroke and Systemic Embolic Events (SEE), Including Subcomponents of Stroke and Composite Event of Ischemic Stroke and SEE in Participants Who Were Administered DU-176b Compared With Placebo (Randomization up to the time of onset of the initial composite event of stroke or systemic embolic event, or study discontinuation, or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Ischemic Stroke and Early Vertical Positioning, the SEVEL Study: a Randomised Controlled Trial Comparing the 3 Months Rankin Score Outcome in Ischemic Stroke Patients; in Whom Early or Delayed Mobilization is Performed
Brief Summary: Even if it is a daily questioning for the stroke physician, no concrete recommendation exists regarding the time-point of the mobilization of stroke patients. In this study, we will compare two mobilisation strategies: early versus delayed "verticalisation". 400 ischemic stroke patients will be included in this prospective randomized controlled trial, equally distributed in two groups. In the early mobilisation procedure the patient is allowed to go and sit outside of the bed the day after the stroke onset, whereas in the other arm, this procedure is delayed to the third day after stroke onset. The outcome in both groups will be assessed by the modified Rankin Scale at 3 months, which is commonly used in stroke study to investigate the functional outcome of the patients.


Options:
A: To demonstrate that functional modified Rankin score at 3 months after stroke onset is better with an earlier mobilization protocol (Rankin score) (3 months)
B: Evolution of the motor control deficiency assessed by the Fugl Meyer (FM) scale modified by LINDMARK (between day 0 and month 3)
C: modified Rankin Score (3 months)
D: Shift ('improvement') in death or disability according to the modified Rankin Scale (mRS) (90 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Double-Blind Placebo Controlled Study of Testosterone in the Adjuvant Treatment of Postmenopausal Women With Aromatase Inhibitor Induced Arthralgias
Brief Summary: This randomized phase III trial studies testosterone to see how well it works compared to placebo in treating postmenopausal patients with arthralgia (joint pain) caused by anastrozole or letrozole. Testosterone may help relieve moderate or severe arthralgia associated with the use of aromatase inhibitors, such as anastrozole or letrozole.


Options:
A: Change in Item #3 (Average) of the Brief Pain Inventory (BPI) Average Pain From Baseline to Month 3 (From baseline to 3 months); Improvement in BPI Average Pain From Baseline to Month 3 (Up to 3 months); Change in BPI Average Change From Baseline Pain Score to Month Six Average Pain Score (Baseline and 6 months); Change in BPI Average Pain From Baseline to Month 1-6 (Baseline and months 1-6)
B: assess efficacy of duloxetine (QD) vs placebo on pain in patients, w/ or w/o MDD during a 6-month therapy phase; evaluate change in pain measured by Brief Pain Inventory score; evaluate endpoint of patient-reported improvement on the Patient's Global Impression of Improvement scale
C: Week 12 Brief Pain Inventory (BPI) Worst Pain/Stiffness Score (12 weeks post-registration)
D: Disease-free Survival (5-year estimate reported at a median follow-up of 72 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Fast Muscle Activation and Stepping Training (FAST) on Balance and Mobility Post-stroke
Brief Summary: The purpose of this study is to determine whether FAST (Fast muscle Activation and Stepping Training) exercises will improve walking balance in individuals after stroke to a greater extent than usual care.

Hypothesis: The primary hypothesis is that improvements in walking balance will be larger following 12 sessions of FAST exercise retraining compared to usual care in persons in the sub-acute phase after stroke.


Options:
A: Percentage of Patients Who Successfully Improved Functional Level of Walking at 1 Year Post-stroke (12 months post-stroke); Walking Speed: Measured During a 10-meter Walk (Baseline and 12 months post-stroke)
B: Functional Independence measured by Barthel Index (Change for functional independence at 4 months)
C: Community Balance and Mobility Scale (Pre treatment and Post treatment (6 weeks))
D: Change in Behavioural Inattention Test (BIT) (6 months post intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Fast Muscle Activation and Stepping Training (FAST) on Balance and Mobility Post-stroke
Brief Summary: The purpose of this study is to determine whether FAST (Fast muscle Activation and Stepping Training) exercises will improve walking balance in individuals after stroke to a greater extent than usual care.

Hypothesis: The primary hypothesis is that improvements in walking balance will be larger following 12 sessions of FAST exercise retraining compared to usual care in persons in the sub-acute phase after stroke.


Options:
A: Percentage of Patients Who Successfully Improved Functional Level of Walking at 1 Year Post-stroke (12 months post-stroke); Walking Speed: Measured During a 10-meter Walk (Baseline and 12 months post-stroke)
B: Balance - Measured With the Berg Balance Scale (2 months)
C: Wolf Motor Function Test (WMFT) Log-transformed Time (Baseline to 1 year post-randomization); Wolf Motor Function Test Time (Baseline to 1 year post-randomization); Stroke Impact Scale (SIS) Hand Function Subscale Score. (Baseline to 1 year post-randomization); Stroke Impact Scale (SIS), Hand Function Subscale, Percentage of Participants That Improved at Least 25 Points From Baseline to End-of-study (One Year Post-randomization) (Baseline to 1 year post-randomization)
D: Community Balance and Mobility Scale (Pre treatment and Post treatment (6 weeks))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Fast Muscle Activation and Stepping Training (FAST) on Balance and Mobility Post-stroke
Brief Summary: The purpose of this study is to determine whether FAST (Fast muscle Activation and Stepping Training) exercises will improve walking balance in individuals after stroke to a greater extent than usual care.

Hypothesis: The primary hypothesis is that improvements in walking balance will be larger following 12 sessions of FAST exercise retraining compared to usual care in persons in the sub-acute phase after stroke.


Options:
A: Trunk Impairment Scale Norwegian Version (12 weeks); ActiGraph WgtX-BT (13 weeks)
B: Change from baseline in Cognitive Function at 3 months (Baseline, Month 3); Change from baseline in Functional Performance at 3 months (Baseline, Month 3); Change from baseline in Muscle Function at 3 months (Baseline, Month 3)
C: Community Balance and Mobility Scale (Pre treatment and Post treatment (6 weeks))
D: upper limb motor function (6 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Randomized, Double-blind, Dose-ranging Study to Evaluate GSK573719 in Combination With Fluticasone Furoate, Fluticasone Furoate Alone, and an Active Control of Fluticasone Furoate/Vilanterol Combination in Subjects With Asthma
Brief Summary: Brief Summary: The purpose of this study is to characterize the dose response of GSK573719 in combination with Fluticasone furoate 100mcg in patients with asthma. Treatment with inhaled Fluticasone furoate and Fluticasone furoate/Vilanterol are included as an active control.

Detailed Description: Long acting muscarinic receptor antagonists (anti-cholinergic bronhcodilator) exert their effects via distinct and complementary bronchodilator mechanisms on large and small airways. Most of the experience with older anti-cholinergics had been with acute use and little is known about their effect in chronic use in asthma. This is a multicenter, randomized, double-blind, crossover study to evaluate 5 doses of inhaled GSK573719 inhaled over 14 days in patients with asthma. Fluticasone furoate (100 mcg) and Fluticasone furoate/Vilanterol (100/59mcg) will be included as an active comparator. Each eligible subject will receive a sequence of 3 of 7 potential treatments for a total of 3 treatment periods per subject. The total duration of subject participation is approximately 14 weeks.


Options:
A: Change From Baseline in Daily Pre-dose Evening (PM) Peak Expiratory Flow (PEF) From Participant Electronic Daily Diary Averaged Over the 4-week Treatment Period (Baseline; Week 1 up to Week 4)
B: Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period (Baseline and Week 24); Change From Baseline in Weighted Mean Serial FEV1 Over 0-24 Hours Post-dose at Week 24 (Baseline and Week 24)
C: General safety and tolerability as measured by ECG, blood pressure, pulse rate and blood and urine tests. Repeated measures on Day 1, 7 and 14 (Repeated measures on Day 1, 7 and 14)
D: Model Predicted Change From Baseline Trough Force Expiratory Volume in 1 Second (FEV1) (Baseline (Day 1) and Day 15 of each treatment period); Percentage of Chance That FF 100 mcg Alone Corrected Change From Baseline FEV1 Response Would Exceed a Target Response by Dose of UMEC Combined With FF 100 mcg (Baseline (Day 1) and Day 15 of each treatment period); Mean Change From Baseline in Trough FEV1 on Day 15 of Each of the 3 Treatment Periods (Baseline (Day 1) and Day 15 of each treatment period)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Randomized, Double-blind, Dose-ranging Study to Evaluate GSK573719 in Combination With Fluticasone Furoate, Fluticasone Furoate Alone, and an Active Control of Fluticasone Furoate/Vilanterol Combination in Subjects With Asthma
Brief Summary: Brief Summary: The purpose of this study is to characterize the dose response of GSK573719 in combination with Fluticasone furoate 100mcg in patients with asthma. Treatment with inhaled Fluticasone furoate and Fluticasone furoate/Vilanterol are included as an active control.

Detailed Description: Long acting muscarinic receptor antagonists (anti-cholinergic bronhcodilator) exert their effects via distinct and complementary bronchodilator mechanisms on large and small airways. Most of the experience with older anti-cholinergics had been with acute use and little is known about their effect in chronic use in asthma. This is a multicenter, randomized, double-blind, crossover study to evaluate 5 doses of inhaled GSK573719 inhaled over 14 days in patients with asthma. Fluticasone furoate (100 mcg) and Fluticasone furoate/Vilanterol (100/59mcg) will be included as an active comparator. Each eligible subject will receive a sequence of 3 of 7 potential treatments for a total of 3 treatment periods per subject. The total duration of subject participation is approximately 14 weeks.


Options:
A: Forced Expiratory Volume in One Second (FEV1) Area Under the Curve 0-24 Hours (AUC0-24h) Response (10 minutes (min) prior to first dose (baseline) and -10 min, 30 min, 60 min, 2 hours (h) , 3 h, 4 h , 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose at week 4)
B: Forced Expiratory Volume in One Second (FEV1) Peak Within 0-3 Hours Post-dose Response (10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h after drug administration)
C: Model Predicted Change From Baseline Trough Force Expiratory Volume in 1 Second (FEV1) (Baseline (Day 1) and Day 15 of each treatment period); Percentage of Chance That FF 100 mcg Alone Corrected Change From Baseline FEV1 Response Would Exceed a Target Response by Dose of UMEC Combined With FF 100 mcg (Baseline (Day 1) and Day 15 of each treatment period); Mean Change From Baseline in Trough FEV1 on Day 15 of Each of the 3 Treatment Periods (Baseline (Day 1) and Day 15 of each treatment period)
D: Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial (baseline and after 16 weeks of treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The GREEN (Growing Right: Eating Eco-Friendly & Nutritious) Project Lunch Box Study
Brief Summary: The central hypothesis of The GREEN Project Lunch Box Study is that a school-based communication campaign that combines healthy eating and eco-friendly messages will improve the quality of foods that children bring from home to school more than a healthy eating campaign alone and compared to a control/delayed intervention condition at the end of one school year.


Options:
A: Changes in the quantity of fruit and vegetables brought from home to school (6 months)
B: Body fat (At the end of the intervention and at a six month follow-up)
C: Change in the selection of meal components (Selection of entrees, milk, fruits, and vegetables) (baseline, up to 3 months post-implementation, and up to 7 months post-implementation); Change in the consumption of meal components (consumption of entrees, milk, fruits, and vegetables) (baseline, up to 3 months post-implementation, and up to 7 months post-implementation)
D: Employee purchases of healthy (green-labeled) items (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Intratumoral Genetic Therapy for Lung Cancer
Brief Summary: The purpose of this study is to determine the dose that the vaccine can be given safely to patients when injected directly into the lung tumor, without any serious side effects.


Options:
A: Overall Survival (Up to 66 months)
B: Maximum Tolerated Dose (MTD) (28 Days)
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 Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 13 Feb 2017 DCO; up to a maximum of approximately 3 years.); Overall Survival (From baseline until death due to any cause. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Odense Overweight Intervention Study (OOIS): A Randomized Controlled Trial on Overweight Prevention in Children.
Brief Summary: Strong and consistent evidence have shown that overweight, including obesity, is an important risk factor for the development of cardiovascular disease (CVD) in adults. Several studies have found an association between overweight in childhood and increased risk of morbidity and mortality later in life. The prevalence of overweight in children and adolescents has increased in recent years, and consequently it is important to identify effective approaches in the prevention and treatment of overweight in young individuals.

Approaches such as resident weight loss camps have shown promising results. A residential camp setting provides an opportunity to increase and control exposure to, for instance, particular foodstuffs, beverages and physical activity opportunities. However, well-designed studies with sufficient participants are still needed on the reversal of overweight in childhood with increased focus on documenting predictors of behavior changes associated with decreases in overweight.

This study is carried through as a randomized controlled trial which investigates the effect of participating in a 6 week health promoting resident for overweight fifth grade children camp followed by 46 weeks of family support.

The study hypothesis is that participating in a 6 week resident camp and a following period of 46 weeks of child and family support will induce a reduction in body mass index (BMI). In addition it is expected that the intensity and duration intervention program is sufficient to cause changes in physiological parameters related to a reduced risk of lifestyle diseases.


Options:
A: Metabolic syndrome score (Change during 3 month of intervention compared with change during 3 month control period); Concentration Performance (Change during 3 month of intervention compared with change during 3 month control period)
B: Our outcome measure was reduction of screen time (4 waves of data)
C: Change in BMI From Baseline to 12 Months Follow up. (Assessed on 2 occasions: 1) Baseline measurements: 4 - 6 weeks before initiation of interventions. 2) 2nd follow up: 52-53 weeks (12 months) after initiation of interventions.)
D: Change from baseline in weekly time in moderate-to-vigorous physical activity at 4 months (baseline and after 4-months of intervention); Change from baseline in the daily time using TV/computer/video games at 4 months (baseline and after 4-months of intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Odense Overweight Intervention Study (OOIS): A Randomized Controlled Trial on Overweight Prevention in Children.
Brief Summary: Strong and consistent evidence have shown that overweight, including obesity, is an important risk factor for the development of cardiovascular disease (CVD) in adults. Several studies have found an association between overweight in childhood and increased risk of morbidity and mortality later in life. The prevalence of overweight in children and adolescents has increased in recent years, and consequently it is important to identify effective approaches in the prevention and treatment of overweight in young individuals.

Approaches such as resident weight loss camps have shown promising results. A residential camp setting provides an opportunity to increase and control exposure to, for instance, particular foodstuffs, beverages and physical activity opportunities. However, well-designed studies with sufficient participants are still needed on the reversal of overweight in childhood with increased focus on documenting predictors of behavior changes associated with decreases in overweight.

This study is carried through as a randomized controlled trial which investigates the effect of participating in a 6 week health promoting resident for overweight fifth grade children camp followed by 46 weeks of family support.

The study hypothesis is that participating in a 6 week resident camp and a following period of 46 weeks of child and family support will induce a reduction in body mass index (BMI). In addition it is expected that the intensity and duration intervention program is sufficient to cause changes in physiological parameters related to a reduced risk of lifestyle diseases.


Options:
A: Body mass index (One school year)
B: Change in BMI From Baseline to 12 Months Follow up. (Assessed on 2 occasions: 1) Baseline measurements: 4 - 6 weeks before initiation of interventions. 2) 2nd follow up: 52-53 weeks (12 months) after initiation of interventions.)
C: N/A
D: Metabolic syndrome score (Change during 3 month of intervention compared with change during 3 month control period); Concentration Performance (Change during 3 month of intervention compared with change during 3 month control period)

Answer: B