TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Canadian Methotrexate and Etanercept Outcome Study: An Open Label Randomized Trial of Etanercept and Methotrexate Versus Etanercept Alone in the Treatment of Rheumatoid Arthritis (CAMEO)
Brief Summary: The purpose of the study is to evaluate the use of etanercept in the treatment of rheumatoid arthritis with or without methotrexate treatment over a 24 month period


Options:
A: Percentage of Participants With a Response as Determined by American College of Rheumatology (ACR) 20% Improvement (ACR20) (Week 48)
B: Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 14 (Week 0 to Week 14)
C: MRI synovitis, bone edema and erosions score (baseline, week 18 and 52)
D: Change From Month 6 to Month 12 in Disease Activity Sscore 28 (DAS28) (Month 6 (randomization) and Month 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Canadian Methotrexate and Etanercept Outcome Study: An Open Label Randomized Trial of Etanercept and Methotrexate Versus Etanercept Alone in the Treatment of Rheumatoid Arthritis (CAMEO)
Brief Summary: The purpose of the study is to evaluate the use of etanercept in the treatment of rheumatoid arthritis with or without methotrexate treatment over a 24 month period


Options:
A: Baseline change in disease activity, assessed as the Disease Activity Score (DAS28) and erythrocyte sedimentation rate, or DAS28-(4)-ESR (Day 85); Incidence and severity of adverse events and clinical laboratory abnormalities as a measure of safety and tolerability of MLTA3698A (Length of study (through Day 85))
B: ACR 20% response (Week 14)
C: Change in disease activity. (6 months)
D: Change From Month 6 to Month 12 in Disease Activity Sscore 28 (DAS28) (Month 6 (randomization) and Month 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Canadian Methotrexate and Etanercept Outcome Study: An Open Label Randomized Trial of Etanercept and Methotrexate Versus Etanercept Alone in the Treatment of Rheumatoid Arthritis (CAMEO)
Brief Summary: The purpose of the study is to evaluate the use of etanercept in the treatment of rheumatoid arthritis with or without methotrexate treatment over a 24 month period


Options:
A: The Proportion of Participants Meeting the American College of Rheumatology (ACR) Criteria of 20% Improvement (ACR20) After 12 Months of Treatment - Intent to Treat Population (Day 1 to Day 365)
B: Proportion of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14 (Week 14)
C: Number of Subjects Experiencing Any Adverse Event (throughout entire study (61 +/- 28.9 weeks on average)); Number of Subjects Experiencing Serious Adverse Event (throughout entire study (61 +/- 28.9 weeks on average)); Number of Subjects Experiencing Any Infection (throughout entire study (61 +/- 28.9 weeks on average))
D: Change From Month 6 to Month 12 in Disease Activity Sscore 28 (DAS28) (Month 6 (randomization) and Month 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind Phase III Study to Evaluate the Efficacy of BI 1356 5 mg and 10 mg vs. Placebo for 12 Weeks and vs. Voglibose 0.6 mg for 26 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control, Followed by an Extension Study to 52 Weeks to Evaluate Long-term Safety
Brief Summary: The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (BI 1356) (5 mg or 10 mg / once daily) compared to placebo given for 12 weeks and voglibose for 26 weeks as mono therapy in patients with type 2 diabetes mellitus with insufficient glycaemic control. Furthermore, long-term safety is evaluated with an extension treatment to 52 weeks.


Options:
A: Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment (Baseline and 52 weeks); Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment (Baseline and 76 weeks)
B: Change From Baseline in HbA1c at Week 12 (12 weeks); Change From Baseline in HbA1c at Week 26 (26 weeks); Examination of Long-term Safety of Linagliptin (52-week Treatment) (52 weeks)
C: Percentage of Participants Achieving and Maintaining Individualized Glycated Hemoglobin A1c (HbA1c) Targets Without Clinically Significant Hypoglycemia (Baseline to last participant visit (up to 72 weeks))
D: Absolute Change in the Endothelial Progenitor Cell (EPC) Number (V0, V2 (month 4), V4 (12 month))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-Blind, Multicenter, Trial to Assess the Effect of High & Low Doses of ZD4522 on Progression of Carotid Artery Atheroma in Moderately Hypercholesterolemic Subjects With Asymptomatic Carotid Stenosis After 24 Months of Dosing.
Brief Summary: The purpose of this study is to examine the changes in the carotid artery when subjects receive high or low doses of rosuvastatin.


Options:
A: Change in intima media thickness as measured by carotid ultrasound
B: Changes in carotid wall volume as measured by MRI scan (At 40 weeks and 104 weeks)
C: Percent Change From Baseline in Mean Wall Thickness (24 months); Change From Baseline in Target (Plaque) to Background (Blood) Ratio From an Index Vessel. (6 months)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-Blind, Multicenter, Trial to Assess the Effect of High & Low Doses of ZD4522 on Progression of Carotid Artery Atheroma in Moderately Hypercholesterolemic Subjects With Asymptomatic Carotid Stenosis After 24 Months of Dosing.
Brief Summary: The purpose of this study is to examine the changes in the carotid artery when subjects receive high or low doses of rosuvastatin.


Options:
A: Assess the effects of rosuvastatin treatment on the change in the mean maximum intima media thickness (IMT) of the 12 vessel segments: the near & far walls of the CCA, the carotid bulb & the ICA
B: Changes in carotid wall volume as measured by MRI scan (At 40 weeks and 104 weeks)
C: Venous thrombosis and/or pulmonary embolism (PE) (Postoperative 4 weeks)
D: Change in intima media thickness as measured by carotid ultrasound

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-Blind, Multicenter, Trial to Assess the Effect of High & Low Doses of ZD4522 on Progression of Carotid Artery Atheroma in Moderately Hypercholesterolemic Subjects With Asymptomatic Carotid Stenosis After 24 Months of Dosing.
Brief Summary: The purpose of this study is to examine the changes in the carotid artery when subjects receive high or low doses of rosuvastatin.


Options:
A: Changes in carotid wall volume as measured by MRI scan (At 40 weeks and 104 weeks)
B: Incidence of venous thromboembolism detected by imaging (30 days)
C: Mortality and days free of organ support (21 days)
D: 28-days ICU mortality (28 days from ICU-admission)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open Label, Randomized, Multi-Center, Phase IIIB, Parallel Group Switching Study to Compare the Efficacy and Safety of Lipid Lowering Agents Atorvastatin and Simvastatin With Rosuvastatin in High Risk Subjects With Type IIa and IIb Hypercholesterolemia.
Brief Summary: The purpose of this study is to determine whether treatment with rosuvastatin following atorvastatin or simvastatin treatment will improve health outcomes for patients at high risk of Coronary heart disease compared to atorvastatin and simvastatin alone.


Options:
A: The change of LDL-C (Baseline to 12 weeks)
B: Percent Change From Baseline (Week 6) in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Week 12 (Baseline (Week 6), Week 12)
C: Low density Lipoprotein cholesterol level - reaching internationally recognised LDL cholesterol goal levels. (16 weeks)
D: Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period (Baseline and Week 8)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open Label, Randomized, Multi-Center, Phase IIIB, Parallel Group Switching Study to Compare the Efficacy and Safety of Lipid Lowering Agents Atorvastatin and Simvastatin With Rosuvastatin in High Risk Subjects With Type IIa and IIb Hypercholesterolemia.
Brief Summary: The purpose of this study is to determine whether treatment with rosuvastatin following atorvastatin or simvastatin treatment will improve health outcomes for patients at high risk of Coronary heart disease compared to atorvastatin and simvastatin alone.


Options:
A: Percentage of Subjects Reporting Adverse Events During Combination Therapy, Either in the Preceding Double-blind Studies or in This Open-label Study (Anytime after initiation of combination therapy (either in the double-blind or open-label study) to within 30 days after the last dose of combination therapy)
B: Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline (Day 0) to the End of the 12-week Double-blind Treatment Phase (12 weeks)
C: Mean Percent Change From Baseline to the Final Visit in High-density Lipoprotein Cholesterol (HDL-C) (Full Analysis Set) (Baseline to 12 Weeks); Mean Percent Change From Baseline to the Final Visit in Triglycerides (Full Analysis Set) (Baseline to 12 Weeks); Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set) (Baseline to 12 Weeks)
D: Low density Lipoprotein cholesterol level - reaching internationally recognised LDL cholesterol goal levels. (16 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Exercise Rehabilitation of Younger and Older People With Claudication
Brief Summary: The purpose of this study is to examine the effect of age and the effect of exercise intensity of rehabilitation programs on claudication pain symptoms and leg circulation of younger and older patients with intermittent claudication.


Options:
A: Total Walking Distance (12 weeks)
B: Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain. (6 months)
C: maximal walking distance
D: Six-minute walk distance (Measured at baseline and follow-up study visits); Summary performance score (Measured at baseline and follow-up study visits)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Exercise Rehabilitation of Younger and Older People With Claudication
Brief Summary: The purpose of this study is to examine the effect of age and the effect of exercise intensity of rehabilitation programs on claudication pain symptoms and leg circulation of younger and older patients with intermittent claudication.


Options:
A: MWD change score (Measured at 6 months); MWD change score (Measured at 6 months); MWD change score (Measured at 6 months)
B: Treadmill maximum walking distance (2 weeks); EACH-Q walking questionnaire score (2 weeks)
C: Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain. (6 months)
D: Combined outcome of ability to walk 400 m without the use of an assistive device or adjudicated evidence of inability to walk 400 m or death; Drop-in, drop-out, and loss to follow-up rates; Established Populations for Epidemiologic Studies of the Elderly (EPESE) physical performance score; 4 m gait speed; 400 m gait speed; Self-reported disability scale

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 2 Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study to Determine the Safety, Pharmacokinetics, and Effectiveness of LDP-02 in Patients With Mildly to Moderately Active Crohn's Disease
Brief Summary: The objectives of this study were to assess the safety and tolerability of LDP-02 in patients with active Crohn's disease who were not receiving corticosteroids or immunosuppressives, to assess the ability of LDP-02 to reduce Crohn's disease activity, and to obtain pharmacokinetic (PK) and pharmacodynamic(PD)information for LDP-02 in patients with active Crohn's disease.


Options:
A: Induction Phase: Percentage of Participants With Crohn's Disease Activity Index (CDAI)-100 Response (Week 10); Maintenance Phase: Percentage of Participants With Clinical Remission (Week 60); Number of Participants Who Experienced at Least One or More Treatment-Emergent Adverse Events (TEAEs) (From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)); Number of Participants With TEAE Related to Body Weight (Weight Decreased) (From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)); Number of Participants With TEAE Related to Vital Signs (From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)); Number of Participants With TEAE Related to Electrocardiogram (ECG) [Bundle Branch Block Right] (From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)); Number of Participants With Markedly Abnormal Values of Laboratory Parameters Values (From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks))
B: remission without corticosteroids and without surgical resection (month 6 and 12 after inclusion)
C: Induction Phase: Percentage of Participants Achieving Clinical Remission at Week 6 (Week 6); Induction Phase: Percentage of Participants With Enhanced Clinical Response at Week 6 (Baseline and Week 6); Maintenance Phase: Percentage of Participants Achieving Clinical Remission at Week 52 (Week 52)
D: The primary outcome measure was the proportion of patients with a clinical response, defined as a reduction from baseline in the CDAI score of at least 70 points at Day 57 (Days 1-57)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Neuroscience-Guided Cognitive Remediation in Adolescents at Risk for Psychosis
Brief Summary: This study will evaluate the effectiveness of intensive computerized cognitive training in preventing the onset of psychotic disorder and improving adaptive functioning in adolescents at high risk of schizophrenia.


Options:
A: Work Activity (6 month and 12 month)
B: Change in Spatial Cognition (Multiple scores are aggregated to arrive at a single composite score) (At 6 weeks and At 12 weeks); Change in Performance on the UCSD Performance-based Skills Assessment (Co-Primary Composite Measure) (At 6 weeks and At 12 weeks)
C: Change from Baseline Social Cognition at 6 months (Baseline (Intake)/6 months follow-up after trianing completion)
D: Cognitive performance, as measured by a neuropsychological battery (Measured at baseline, Weeks 8 and Month 6, 12, 18, and 24 follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Neuroscience-Guided Cognitive Remediation in Adolescents at Risk for Psychosis
Brief Summary: This study will evaluate the effectiveness of intensive computerized cognitive training in preventing the onset of psychotic disorder and improving adaptive functioning in adolescents at high risk of schizophrenia.


Options:
A: Scale Of Prodromal Symptoms total score (8 weeks)
B: Incidence of Remission From Attenuated Psychosis Syndrome (APS) Within a 52-week Timeframe (Up to 52 weeks.)
C: Cognitive performance, as measured by a neuropsychological battery (Measured at baseline, Weeks 8 and Month 6, 12, 18, and 24 follow-up)
D: Change in subthreshold psychotic (positive and negative) symptoms (Change from pretreatment (assessed for the 3 months prior to randomization) to 12 month reassessment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: GvHD Prophylaxis With ATG-Fresenius S in Allogeneic Stem Cell Transplantation From Matched Unrelated Donors: A Randomized Phase III Multicenter Trial Comparing a Standard GvHD Prophylaxis With Cyclosporine A and Methotrexate With Additional Pretransplant ATG-Fresenius S
Brief Summary: The study aim is to evaluate the influence of the anti-T-lymphocyte globulin ATG-Fresenius S given pre-transplant in addition to standard GvHD prophylaxis with cyclosporine A and a short course of methotrexate with respect to efficacy and safety.


Options:
A: Number of participants with cGVHD as assessed by chronic graft versus host disease grading criteria (refer to NIH criteria) (three years)
B: Incidence of acute GVHD, and chronic GVHD (2 years)
C: Incidence of Epstein-Barr virus(EBV) viremia (1 year)
D: Primary: Early treatment failure defined by the occurrence of severe acute GvHD (°III-°IV) or early mortality within 100 days post transplantation. (100 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo-controlled Study of the Effect of RO4607381 on Progression or Regression of Atherosclerotic Plaque in Patients With Coronary Heart Disease (CHD) Including Patients With Other CHD Risk Factors
Brief Summary: This study will assess the effect of RO4607381, compared to placebo, on atherosclerotic plaque in patients with coronary heart disease (CHD) including patients with other CHD risk factors. After a pre-randomisation period during which positron emission tomography computed tomography (PET/CT) and MRI will be conducted, patients will be randomized to receive either RO4607381 600mg po daily, or placebo po daily. PET/CT and MRI scans will be taken at intervals during the study. The anticipated time on study treatment is 2 years, and the target sample size is 100 individuals.


Options:
A: Percent Change From Baseline in Mean Wall Thickness (24 months); Change From Baseline in Target (Plaque) to Background (Blood) Ratio From an Index Vessel. (6 months)
B: The time to first occurrence of a major cardiovascular disease event
C: The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death (For each participant, the first occurrence of the composite primary efficacy outcome after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.); The First Occurrence of the Primary Safety Outcome Major Bleeding Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria (For each participant, the first occurrence of modified ISTH major bleeding after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.)
D: Prevention of Type 2 Diabetes (2.4 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Proof-of-concept Study to Evaluate the Benefit From add-on Therapy With Montelukast Versus Salmeterol in Children With Asthma Carrying the Arg/Arg-16 beta2-receptor Genotype
Brief Summary: The purpose of this study is to determine whether patients with asthma who carry a genotype associated with adverse outcomes with long-acting beta-2 agonists like salmeterol show greater benefit from the use of an asthma drug that works via alternative pathways like montelukast.


Options:
A: Pulmonary Function as Measured by Normalized FEV1 Over a 4-6 Year Period (At the end of treatment, 4-6 years from baseline assessment)
B: Oral montelukast is associated with reduced school absences in comparison to inhaled salmeterol over a period of 1 year in Arg/Arg-16 asthmatic children (Every 3 months)
C: Treatment Failure (16 weeks)
D: Change in Forced Expiratory Volume in 1 s(FEV-1) from Baseline (Week 0) to Week 12. (Week 0 and 12 visits); Discontinuation due to lack of efficacy. (Whole duration of study)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Proof-of-concept Study to Evaluate the Benefit From add-on Therapy With Montelukast Versus Salmeterol in Children With Asthma Carrying the Arg/Arg-16 beta2-receptor Genotype
Brief Summary: The purpose of this study is to determine whether patients with asthma who carry a genotype associated with adverse outcomes with long-acting beta-2 agonists like salmeterol show greater benefit from the use of an asthma drug that works via alternative pathways like montelukast.


Options:
A: Treatment Failure (16 weeks)
B: N/A
C: Oral montelukast is associated with reduced school absences in comparison to inhaled salmeterol over a period of 1 year in Arg/Arg-16 asthmatic children (Every 3 months)
D: To evaluate distal airway function using high-resolution CT and lung function test (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects on Growth and Tolerance of Hydrolyzed Formulas Fed to Term Infants
Brief Summary: A study to evaluate the growth and development of term infants fed either an extensively hydrolyzed formula with probiotics, a partially hydrolyzed formula with probiotics, or an extensively hydrolyzed formula without probiotics


Options:
A: Intestinal permeability will be determined at the age of 3, 6, 9 and 12 months with the lactulose/mannitol test Intestinal permeability at the age of 9 months assessed with the lactulose/mannitol test (3, 6, 9 and 12 months)
B: infants' intake, length of feeding and patterning of feeding of Nutramigen relative to Enfamil (infant-led feeding condition) (0.5-8.5 months)
C: Number of Participants With Type 1 Diabetes Mellitus (12 and 18 months and annually from 2 years up to 14 years)
D: Growth (weight) (106 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects on Growth and Tolerance of Hydrolyzed Formulas Fed to Term Infants
Brief Summary: A study to evaluate the growth and development of term infants fed either an extensively hydrolyzed formula with probiotics, a partially hydrolyzed formula with probiotics, or an extensively hydrolyzed formula without probiotics


Options:
A: Beta-cell autoantibodies (3,6,12,24,36,48,60,72 months)
B: Number of Participants With Type 1 Diabetes Mellitus (12 and 18 months and annually from 2 years up to 14 years)
C: Growth (weight) (106 days)
D: Number of infants who discontinue from study formula due to formula intolerance as documented by the investigator (60 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects on Growth and Tolerance of Hydrolyzed Formulas Fed to Term Infants
Brief Summary: A study to evaluate the growth and development of term infants fed either an extensively hydrolyzed formula with probiotics, a partially hydrolyzed formula with probiotics, or an extensively hydrolyzed formula without probiotics


Options:
A: Growth (weight) (106 days)
B: Beta-cell autoantibodies (3,6,12,24,36,48,60,72 months)
C: Number of Participants With Type 1 Diabetes Mellitus (12 and 18 months and annually from 2 years up to 14 years)
D: infants' intake, length of feeding and patterning of feeding of Nutramigen relative to Enfamil (infant-led feeding condition) (0.5-8.5 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double Blind, Crossover, Placebo-Controlled Clinical Trial to Assess the Effects of a Mouthwash Containing Chlorine Dioxide on Oral Malodor
Brief Summary: A mouthwash containing chlorine dioxide would be effective to reduce oral malodor.


Options:
A: Volatile sulfur compounds (VSCs) (5 weeks)
B: Oral malodor (7 days)
C: Oral malodor was evaluated at before rinsing, right after rinsing and follows up every 30 minutes till 4 hours with organoleptic measurements. (4 hours)
D: Periodontal Pocket Depth (PPD) (30 day.)

Answer: C