TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: GlObal Secondary Prevention strategiEs to Limit Event Recurrence After Myocardial Infarction. GOSPEL Study
Brief Summary: Cardiac rehabilitation programmes are a proven treatment for individuals with recent myocardial infarction, resulting in reduced morbidity and mortality compared to usual care. Unfortunately, following completion of a cardiac rehabilitation programme, risk factors and lifestyle behaviours may deteriorate. The GOSPEL study investigates the benefits of a programme of continued educational and behavioural intervention to achieve optimal long-term secondary prevention goals.


Options:
A: Duration and Intensity of Physical Activity (1 month, 3 months and 12 months after discharge)
B: change in physical activity (4 months)
C: cardiovascular mortality; non fatal re-MI; angina requiring hospitalization; urgent revascularization procedures; hospitalization for heart failure; non fatal stroke
D: Phase 1: patient who've received interventions based on evidence proportion informed by the indicators (9 months); Phase 2: increase of prescription of evidence based treatment in clinical practice (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: GlObal Secondary Prevention strategiEs to Limit Event Recurrence After Myocardial Infarction. GOSPEL Study
Brief Summary: Cardiac rehabilitation programmes are a proven treatment for individuals with recent myocardial infarction, resulting in reduced morbidity and mortality compared to usual care. Unfortunately, following completion of a cardiac rehabilitation programme, risk factors and lifestyle behaviours may deteriorate. The GOSPEL study investigates the benefits of a programme of continued educational and behavioural intervention to achieve optimal long-term secondary prevention goals.


Options:
A: Physical activity: measured at baseline (day of hospital discharge), 6 months and 12 months via: (Baseline, 6 and 12 months)
B: Proportion of Patients With Hospital Length of Stay Greater Than 7 Days. (Post-surgery (approximately 9 weeks after baseline))
C: cardiovascular mortality; non fatal re-MI; angina requiring hospitalization; urgent revascularization procedures; hospitalization for heart failure; non fatal stroke
D: Change in Coronary Flow Reserve following the diet or training intervention and a maintenance period (0, 12 and 52 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Double-Blind, Placebo- and Active-Control, Parallel-arm, Phase III Trial With Controlled Adjustment of Dose to Evaluate the Efficacy and Safety of CG5503 Extended-Release (ER) in Patients With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee
Brief Summary: The purpose of this trial is to evaluate the effectiveness (level of pain control) and safety of orally administered tapentadol (CG5503) Extended Release (ER) (base) at doses of 100-250 mg twice daily in patients with moderate to severe chronic pain due to osteoarthritis of the knee, in comparison with placebo and Oxycodone Controlled Release (CR).


Options:
A: Change From Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale(NRS) Over the Last Week of the Maintenance Period at Week 12. (Baseline and 12 weeks (Primary endpoint is the average pain intensity score during the last week of the maintenance period).)
B: Number of Participants That Responded to Treatment (6 weeks)
C: Number of Participants With Treatment-emergent Adverse Events (TEAE) (52 weeks)
D: Change From Baseline (at Randomization) in Average Pain Intensity on an 11-point Numerical Rating Scale (NRS) Over the Last Week of the Double-blind Maintenance Period at Week 12 (Baseline and 12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Multicentre, Long-Term Extension Study of Etanercept in Ankylosing Spondylitis
Brief Summary: The primary objective of this study was to determine the long-term safety of etanercept in adults with AS who had completed study 0881A3-311-EU.


Options:
A: Proportion of subjects achieving a good or moderate DAS28 response (as defined by the EULAR28 response criteria) at Week 12
B: N/A
C: remission without corticosteroids and without surgical resection (month 6 and 12 after inclusion)
D: Visual analogue scale pain score, Oswestry disability index, medication intake (7 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes: A 20-week Randomised, Double-blind, Placebo-controlled, Six Armed Parallel Group, Multi-centre, Multinational Trial With an Open Label Orlistat Comparator Arm and With an 84-week Extension Period
Brief Summary: This trial is conducted in Europe. The purpose of the 20-week trial is to investigate the efficacy of liraglutide to induce body weight loss and the purpose of the extension is to evaluate the long term safety and tolerability of liraglutide.

Trial has the following trial periods: A 20-week randomised, double-blind, placebo-controlled, six-armed parallel-group, multi-centre, multinational trial with an open label orlistat comparator arm followed by an 84 week extension period.


Options:
A: Change From Baseline in Apnoea-hypopnoea Index (AHI) (Week 0, Week 32)
B: Change in Weight Reported at 14 Weeks (Baseline and 14 weeks)
C: Mean Change From Baseline in Body Weight at Week 20 (Week 0, week 20)
D: Change in Body Weight (24 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes: A 20-week Randomised, Double-blind, Placebo-controlled, Six Armed Parallel Group, Multi-centre, Multinational Trial With an Open Label Orlistat Comparator Arm and With an 84-week Extension Period
Brief Summary: This trial is conducted in Europe. The purpose of the 20-week trial is to investigate the efficacy of liraglutide to induce body weight loss and the purpose of the extension is to evaluate the long term safety and tolerability of liraglutide.

Trial has the following trial periods: A 20-week randomised, double-blind, placebo-controlled, six-armed parallel-group, multi-centre, multinational trial with an open label orlistat comparator arm followed by an 84 week extension period.


Options:
A: Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26 (Week 0, Week 26); Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (Week 0, Week 52); Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78 (Week 0, Week 78); Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78 (Week 52, Week 78)
B: Mean Change From Baseline in Body Weight at Week 20 (Week 0, week 20)
C: Change in Glycosylated A1c (HbA1c) at Week 26 (week 0, week 26); Change in Glycosylated A1c (HbA1c) at Week 104 (week 0, week 104)
D: HbA1c (after 26 weeks of treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Comparative (Double-blind, Double-dummy) Randomised, Multi-centre Study to Assess the Efficacy of Pyronaridine Artesunate (180:60mg) Versus Coartem® (Artemether Lumefantrine) in Children & Adult Patients With Falciparum Malaria
Brief Summary: The primary objective of this phase III study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (Pyramax®, PA) with that of Coartem® (artemether lumefantrine, AL) in children and adults with uncomplicated P falciparum malaria in Africa and South East Asia.


Options:
A: PCR-corrected adequate clinical and parasitological response (ACPR) (day 28 after initial dose)
B: PCR-Corrected Adequate Clinical and Parasitological Response (ACPR) Rate on Day 28 (Day 28)
C: Crude Cure Rate on Day 14 (Day 14)
D: Percentage of Participants With PCR-Corrected ACPR on Day 28 (Day 28)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Comparative (Double-blind, Double-dummy) Randomised, Multi-centre Study to Assess the Efficacy of Pyronaridine Artesunate (180:60mg) Versus Coartem® (Artemether Lumefantrine) in Children & Adult Patients With Falciparum Malaria
Brief Summary: The primary objective of this phase III study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (Pyramax®, PA) with that of Coartem® (artemether lumefantrine, AL) in children and adults with uncomplicated P falciparum malaria in Africa and South East Asia.


Options:
A: Percentage of Participants With PCR-Corrected ACPR on Day 28 (Day 28)
B: PCR-Corrected Adequate Clinical and Parasitological Response (ACPR) Rate on Day 28 (Day 28)
C: parasite clearance times in relation to artesunate/DHA plasma concentrations (PK-PD) (June 2008)
D: Percentage of Subjects With PCR-corrected Adequate Clinical and Parasitological Response (ACPR) on Day 28 (Day 28)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Comparative (Double-blind, Double-dummy) Randomised, Multi-centre Study to Assess the Efficacy of Pyronaridine Artesunate (180:60mg) Versus Coartem® (Artemether Lumefantrine) in Children & Adult Patients With Falciparum Malaria
Brief Summary: The primary objective of this phase III study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (Pyramax®, PA) with that of Coartem® (artemether lumefantrine, AL) in children and adults with uncomplicated P falciparum malaria in Africa and South East Asia.


Options:
A: PCR-Corrected ACPR at Day 28 (Day 28)
B: Percentage of Participants With PCR-Corrected ACPR on Day 28 (Day 28)
C: Percentage of Subjects With PCR-corrected Adequate Clinical and Parasitological Response (ACPR) on Day 28 (Day 28)
D: PCR-Corrected Adequate Clinical and Parasitological Response (ACPR) Rate on Day 28 (Day 28)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Eight-Week, Randomized, Double Blind, Two Parallel Groups, Study to Assess Clinical Response of Duloxetine 60 mg and 120 Per Day in Patients Hospitalized for Severe Depression
Brief Summary: An eight-week, randomized, double blind, two parallel groups, study to assess clinical response of duloxetine 60 milligrams (mg) and 120 mg per day in patients hospitalized for severe depression.


Options:
A: Change From Baseline to 4 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (Baseline to Week 4)
B: Change From Baseline (End of Phase A [Week 8]) to Week 14 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score for the Efficacy Sample. (Baseline and Week 14); Change From Baseline (End of Phase A [Week 8]) to Week 14 in MADRS Total Score for the Efficacy Sample Per the Final Protocol. (Baseline and Week 14)
C: Mean Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (Baseline (the end of the SSRI/SNRI treatment period), at completion of administration)
D: Mean Change in the Montgomery Åsberg Depression Rating Scale (MADRS) (Baseline (Week 8) and Week 14)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-Label Study in the Asia-Pacific Region Comparing the Safety and Efficacy of Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis
Brief Summary: The purpose of this study is to compare the efficacy of etanercept with usual disease-modifying anti-rheumatic drug (DMARD) therapy in the treatment of moderate to severe rheumatoid arthritis (RA) over 16 weeks in the Asia Pacific region.


Options:
A: Double-blind Period: Mean Synovitis Scores at Baseline As Measured by the Rheumatoid Arthritis Clinical Trials 6 (OMERACT 6) Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) (At baseline); Double-blind Period: Mean Change From Baseline in OMERACT 6 Wrist Synovitis Score: Planned Analysis Using Non-Parametric ANCOVA (Baseline to Day 113); Double-blind Period: Mean Change From Baseline in OMERACT 6 Wrist Synovitis Score: Post Hoc Sensitivity Analysis Using Parametric ANCOVA Analysis (Baseline to Day 113)
B: 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))
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: Change From Baseline in Adjusted Mean of American College of Rheumatology Response (ACR-N) Area Under Curve (AUC) Over 16 Weeks (16 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-Label Study in the Asia-Pacific Region Comparing the Safety and Efficacy of Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis
Brief Summary: The purpose of this study is to compare the efficacy of etanercept with usual disease-modifying anti-rheumatic drug (DMARD) therapy in the treatment of moderate to severe rheumatoid arthritis (RA) over 16 weeks in the Asia Pacific region.


Options:
A: Number of Participants Who Achieved American College of Rheumatology (ACR) 20 Response at Week 14 (Week 14); Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 24 (Baseline (Week 0) and Week 24)
B: Percentage of patients with ACR 20 response (Week 24); AEs, laboratory parameters, vital signs, ECGs. (Throughout study)
C: Number of patients who achieve a DAS28 < 3.2 (0, 1, 3, 6, 9, 12 and 24 months (DAS28))
D: Change From Baseline in Adjusted Mean of American College of Rheumatology Response (ACR-N) Area Under Curve (AUC) Over 16 Weeks (16 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-Label Study in the Asia-Pacific Region Comparing the Safety and Efficacy of Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis
Brief Summary: The purpose of this study is to compare the efficacy of etanercept with usual disease-modifying anti-rheumatic drug (DMARD) therapy in the treatment of moderate to severe rheumatoid arthritis (RA) over 16 weeks in the Asia Pacific region.


Options:
A: Change from Baseline in the Disease Activity Score (C-reactive protein) [DAS28(CRP)] for CDP6038 and placebo (Baseline, Week 12)
B: Percentage of Patients With an Improvement of at Least 50% in American College of Rheumatology (ACR) Score (ACR50) From Baseline at Week 24 (Baseline to Week 24)
C: Change From Baseline in Adjusted Mean of American College of Rheumatology Response (ACR-N) Area Under Curve (AUC) Over 16 Weeks (16 weeks)
D: Clinical Disease Activity Index (CDAI) Remission (≤2.8) at Both Week 20 and Week 24 (Week 20 and Week 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-Label Study in the Asia-Pacific Region Comparing the Safety and Efficacy of Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis
Brief Summary: The purpose of this study is to compare the efficacy of etanercept with usual disease-modifying anti-rheumatic drug (DMARD) therapy in the treatment of moderate to severe rheumatoid arthritis (RA) over 16 weeks in the Asia Pacific region.


Options:
A: EULAR Good Response (at 24 weeks); ACR50 Response Rate (at 24 weeks); Radiographic Progression Defined by Change in Van Der Heijde-modified Total Sharp Score (at 52 weeks)
B: N/A
C: Change From Baseline in Adjusted Mean of American College of Rheumatology Response (ACR-N) Area Under Curve (AUC) Over 16 Weeks (16 weeks)
D: Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports (Includes laboratory test abnormality data for all visits and adverse event data up to 999 days after last dose of study drug); Extension Period: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) (Baseline (Day 1 at Entry of Extension Period) up to 28 days after last study drug dose in Extension Period (13 Months)); Extension Period: Number of Participants With Laboratory Test Abnormalities (Baseline (Day 1 at Entry of Extension Period) up to 28 days after last study drug dose in Extension Period (13 Months)); Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis (Includes AEs for every visit and up to 999 days after last dose of study drug); Extension Period: Percentage of Participants With Adverse Events and Who Discontinued Treatment Due to Adverse Events to Assess Long-term Safety and Tolerability of Tofacitinib (Baseline (Day 1 at Entry of Extension Period) up to Month 6 of Extension Period; Month 6 of Extension Period to Month 12 of Extension Period)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Randomized, Double-Blind, Parallel-Group Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel Compared With Adapalene Topical Gel, 0.1%; Benzoyl Peroxide Topical Gel, 2.5% and Topical Gel Vehicle in Subjects With Acne Vulgaris
Brief Summary: This was a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations were performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a participant should remain the same during the study.

The primary objective was to demonstrate the superiority in efficacy and assess safety of adapalene/benzoyl peroxide topical gel (adapalene/benzoyl peroxide gel) versus adapalene topical gel, 0.1% (adapalene monad); benzoyl peroxide topical gel, 2.5% (benzoyl peroxide monad) and topical gel vehicle (gel vehicle) in the treatment of acne vulgaris for up to 12 weeks.


Options:
A: Percentage of Participants Who Achieved Success Rate 0 (Clear) or 1 (Almost Clear) on the Investigator Global Assessment (IGA) Scale at Week 12 (Last Observation Carried Forward) (At Week 12); Change in Inflammatory Lesion Count From Baseline to Week 12 (Baseline to Week 12); Change in Noninflammatory Lesion Count From Baseline to Week 12 (Baseline to Week 12)
B: Mean Change From Baseline in Erythema at Weeks 1, 2, 4, 8, and 12 (Baseline and Weeks 1, 2, 4, 8, and 12); Mean Change From Baseline in Dryness at Weeks 1, 2, 4, 8, and 12 (Baseline and Weeks 1, 2, 4, 8, and 12); Mean Change From Baseline in Peeling at Weeks 1, 2, 4, 8, and 12 (Baseline and Weeks 1, 2, 4, 8, and 12); Mean Change From Baseline in Burning/Stinging at Weeks 1, 2, 4, 8, and 12 (Baseline and Weeks 1, 2, 4, 8, and 12); Mean Change From Baseline in Itching at Weeks 1, 2, 4, 8, and 12 (Baseline and Weeks 1, 2, 4, 8, and 12); Mean Change From Baseline in Oiliness at Weeks 1, 2, 4, 8, and 12 (Baseline and Weeks 1, 2, 4, 8, and 12); Mean Change From Baseline in Skin Overall Comfort at Weeks 1, 2, 4, 8, and 12 (Baseline and Weeks 1, 2, 4, 8, and 12)
C: Success Rate (Week 12); Changes From Baseline in Inflammatory Lesion Counts (Baseline - Week12); Changes From Baseline in Non-Inflammatory Lesion Counts (Baseline - Week 12)
D: Part 1: Total Atrophic Acne Scar Count Per Half-face (Week 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind Study to Evaluate the Effect of Various Re-treatment Regimens of MabThera in Combination With Methotrexate on Treatment Response in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate.
Brief Summary: This study will evaluate the efficacy and safety of various treatment and retreatment regimens of MabThera. All patients will receive concomitant methotrexate, 10-25mg once weekly either orally or parenterally. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.


Options:
A: Percentage of Participants With a Response as Determined by American College of Rheumatology (ACR) 20% Improvement (ACR20) (Week 48)
B: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 (Month 6); Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 (Baseline, Month 3); Percentage of Participants Achieving 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)
C: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3 (Month 3); 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 3 (Month 3)
D: Clinical Disease Activity Index (CDAI) Remission (≤2.8) at Both Week 20 and Week 24 (Week 20 and Week 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind Study to Evaluate the Effect of Various Re-treatment Regimens of MabThera in Combination With Methotrexate on Treatment Response in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate.
Brief Summary: This study will evaluate the efficacy and safety of various treatment and retreatment regimens of MabThera. All patients will receive concomitant methotrexate, 10-25mg once weekly either orally or parenterally. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.


Options:
A: Percentage of Participants With a Response as Determined by American College of Rheumatology (ACR) 20% Improvement (ACR20) (Week 48)
B: Double-blind Period: Number of Participants Achieving American College of Rheumatology (ACR) 20 Response at Day 169 (Day 169); Anti-TNF Failure Sub-Study Double Blind Period : Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Response in Anti-TNF Failure Population (Days 85, and 169 and postvisits on Days 28, 56, and 85)
C: Change From Baseline in Adjusted Mean of American College of Rheumatology Response (ACR-N) Area Under Curve (AUC) Over 16 Weeks (16 weeks)
D: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 6 (Week 6)

Answer: A