TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects on Colesevelam HC1 (WelChol®) on Insulin Sensitivity in Subjects With Type 2 Diabetes Mellitus
Brief Summary: This study is designed to test whether WelChol (colesevelam HC1) improves blood sugar control in patients with type 2 diabetes by making their own insulin work more efficiently.


Options:
A: - To assess the additional lowering of HbA1c achieved by; addition of WelChol® to current antidiabetic therapy
B: First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. (4.9 years); First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. (4.7 years); First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. (4.7 years)
C: Percent Change of Hemoglobin A1C (HbA1C) From Baseline to 16 Weeks When Given as Initial Therapy to Drug-naïve, Diabetic Subjects. (Baseline to 16 weeks); Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) in Pre-Diabetic Subjects From Baseline to 16 Weeks (Baseline to 16 Weeks)
D: To evaluate the effect of 8 weeks treatment with WelChol on insulin sensitivity,as measured by the hyperinsulinemic-euglycemic clamp method, i.e., placebo-corrected change from baseline in M-value. (8 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Brief Summary: The purpose of this study is to assess the clinical effectiveness and safety of golimumab intravenous (IV) infusions every 12 weeks with or without Methotrexate (MTX), compared with MTX alone, in patients with active rheumatoid arthritis (RA) despite concurrent MTX treatment. In addition, the safety of subcutaneous (SC) golimumab injections following transition from IV golimumab infusions will also be evaluated.


Options:
A: American College of Rheumatology (ACR)-20 responder rate at Week 24 (24 weeks)
B: American college of Rheumatolofy (ACR)-20 responder rate at Week 24
C: Change From Baseline to Week 24 in the Disease Activity Score 28 (DAS28) (Baseline to Week 24)
D: Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 14 (Week 0 to Week 14)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Brief Summary: The purpose of this study is to assess the clinical effectiveness and safety of golimumab intravenous (IV) infusions every 12 weeks with or without Methotrexate (MTX), compared with MTX alone, in patients with active rheumatoid arthritis (RA) despite concurrent MTX treatment. In addition, the safety of subcutaneous (SC) golimumab injections following transition from IV golimumab infusions will also be evaluated.


Options:
A: 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 Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3 (Month 3)
B: American College of Rheumatology 20% (ACR20) Response at Week 12 (Baseline, Week 12)
C: Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 14 (Week 0 to Week 14)
D: Percentage of Participants Who Achieved Remission by Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) Criteria at Month 12 and at Both Months 12 and 18 (Randomization to Months 12 and 18)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Brief Summary: The purpose of this study is to assess the clinical effectiveness and safety of golimumab intravenous (IV) infusions every 12 weeks with or without Methotrexate (MTX), compared with MTX alone, in patients with active rheumatoid arthritis (RA) despite concurrent MTX treatment. In addition, the safety of subcutaneous (SC) golimumab injections following transition from IV golimumab infusions will also be evaluated.


Options:
A: Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 14 (Week 0 to Week 14)
B: 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 Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3 (Month 3)
C: Change From Month 6 to Month 12 in Disease Activity Sscore 28 (DAS28) (Month 6 (randomization) and Month 12)
D: 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)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Acoustic Assessment of Nebulized Epinephrine Versus Albuterol for RSV Bronchiolitis- a Double Blind Study
Brief Summary: Bronchiolitis is a common disease of infancy and a main reason for infants' hospital admissions in the first 2 years of life. The main cause of bronchiolitis is RSV (respiratory syncytial virus). Though, Treatment is mainly supportive, the treatment benefit of nebulized epinephrine or albuterol has been largely debated for the past years. Most of the clinical studies used clinical parameters to detect and compare the effectiveness of such medical interventions. In this study we will use non invasive computerized method of wheeze and crackles quantification to compare the effectiveness of nebulized epinephrine vs albuterol in RSV Bronchiolitis.


Options:
A: Respiratory Assessment Change Score (RACS) (Baseline and 1 hour)
B: respiratory clinical score; computerized quantification of wheezing and crackles
C: Successful hospital discharge at three days
D: Change in Modified Wood's Clinical Asthma Score (M-WCAS) From Baseline to 240 Minutes (240 Minutes)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of the 'Mother and Baby' Program on New Mothers' Psychological and Physical Well-Being.
Brief Summary: The study investigates the effect of the 'Mother and Baby' (M\&B) program on the psychological health and well-being of new mothers 6-10 weeks following the birth of their baby. The M\&B program is an 8-week program of group exercise and education sessions provided by various health professionals. The design of the study is a comprehensive cohort design, including a randomised controlled trial. The primary outcome measure is the Affect Balance Scale. The hypotheses are:

1. The M\&B program has a positive effect on new mothers' psychological health and well-being.
2. The M\&B program increases participation in regular physical activity.
3. the M\&B program benefits first time mothers more than women who have had more than one child.


Options:
A: Body weight (12 weeks)
B: Infant weight for height (One year after study entry)
C: Affect Balance Scale (4 weeks)
D: BMI change from baseline to 12 months post-intervention (24 months postpartum) will be assessed via self-report and validated by in-person weight measurement. The proportion of women who lose 10% of baseline BMI

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A One-Year, Randomized, Open-Label, Parallel-Arm, Phase 3 Long-Term Safety Trial, With Controlled Adjustment of Dose, of Multiple Doses of CG5503 PR and Oxycodone CR in Subjects With Chronic Pain
Brief Summary: The purpose of this study is to evaluate the safety profile of tapentadol (CG5503) PR at doses of 100 mg - 250 mg administered twice daily over a maximum one year period to patients with at least a 3-month history of low back pain, or pain caused by knee or hip osteoarthritis.


Options:
A: Number of Participants That Responded to Treatment (6 weeks)
B: Number of Participants With Treatment-emergent Adverse Events (TEAE) (52 weeks)
C: 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)
D: Change From Baseline of the Average Pain Intensity Overall in the 12-week Maintenance Period of the Daily Pain Intensity on an 11-point Numeric Rating Scale (NRS). (Change from baseline over the 12 week Maintenance Period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A One-Year, Randomized, Open-Label, Parallel-Arm, Phase 3 Long-Term Safety Trial, With Controlled Adjustment of Dose, of Multiple Doses of CG5503 PR and Oxycodone CR in Subjects With Chronic Pain
Brief Summary: The purpose of this study is to evaluate the safety profile of tapentadol (CG5503) PR at doses of 100 mg - 250 mg administered twice daily over a maximum one year period to patients with at least a 3-month history of low back pain, or pain caused by knee or hip osteoarthritis.


Options:
A: Average Daily Pain Scores - BS11 Pain Scores. (every day over a 12 week study duration.)
B: Change From Baseline in Knee Pain Intensity Measured by Numeric Rating Scale (NRS) at Week 12 (Baseline, Week 12); Change From Baseline in Knee Pain Intensity Measured by Visual Analog Scale (VAS) at Week 12 (Baseline, Week 12); Change From Baseline in Western Ontario and McMaster (WOMAC) Osteoarthritis Index Pain Subscale Score at Week 12 (Baseline, Week 12); Change From Baseline in Western Ontario and McMaster (WOMAC) Osteoarthritis Index Physical Function Subscale Score at Week 12 (Baseline, Week 12); Change From Baseline in Western Ontario and McMaster (WOMAC) Osteoarthritis Index Stiffness Subscale Score at Week 12 (Baseline, Week 12); Change From Baseline in Western Ontario and McMaster (WOMAC) Osteoarthritis Index Total Score at Week 12 (Baseline, Week 12); Change From Baseline in Knee Adduction Moment at Week 12 (Baseline, Week 12); Change From Baseline in Quadriceps Inhibition at Week 12 (Baseline, Week 12); Change From Baseline in Peak Ground Reaction Force at Week 12 (Baseline, Week 12); Change From Baseline in Total Ground Reaction Force at Week 12 (Baseline, Week 12); Change From Baseline in Stride Length at Week 12 (Baseline, Week 12); Change From Baseline in Walking Speed at Week 12 (Baseline, Week 12); Change From Baseline in Cadence at Week 12 (Baseline, Week 12); Change From Baseline in Patient Global Assessment of Arthritic Condition (PGAAC) Score at Week 12 (Baseline, Week 12)
C: Number of Participants With Treatment-emergent Adverse Events (TEAE) (52 weeks)
D: 5-Day Sum of Pain Intensity Difference (SPID5) (Day 1 to Day 5); Spontaneous Bowel Movements Per Week (SBMs/Week) (Week 1 to Week 2)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicentre, Randomised, Double-Blind, Double Dummy, Parallel Group, 104-week Study to Compare the Effect of the Salmeterol/Fluticasone Propionate Combination Product (SERETIDE*) 50/500mcg Delivered Twice Daily Via the DISKUS*/ACCUHALER* Inhaler With Tiotropium Bromide 18 mcg Delivered Once Daily Via the HandiHaler Inhalation Device on the Rate of Health Care Utilisation Exacerbations in Subjects With Severe Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: This is a comparator study to assess the relative efficacy of the combination product fluticasone propionate/salmeterol 50/500 and tiotropium bromide on the rate of exacerbations of chronic obstructive pulmonary disease (COPD) over a two year study interval.


Options:
A: Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24) (Baseline and Day 169)
B: Rate of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in QVA149 and NVA237 Treatment Arms During the Treatment Period. (64 weeks)
C: Rate of healthcare utilisation based exacerbations of COPD
D: Change From Baseline Trough in 24-Hour Weighted Mean FEV1 on Treatment Day 84 (Baseline (Day 1) and Day 84)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicentre, Randomised, Double-Blind, Double Dummy, Parallel Group, 104-week Study to Compare the Effect of the Salmeterol/Fluticasone Propionate Combination Product (SERETIDE*) 50/500mcg Delivered Twice Daily Via the DISKUS*/ACCUHALER* Inhaler With Tiotropium Bromide 18 mcg Delivered Once Daily Via the HandiHaler Inhalation Device on the Rate of Health Care Utilisation Exacerbations in Subjects With Severe Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: This is a comparator study to assess the relative efficacy of the combination product fluticasone propionate/salmeterol 50/500 and tiotropium bromide on the rate of exacerbations of chronic obstructive pulmonary disease (COPD) over a two year study interval.


Options:
A: Change in trough FEV1 for tiotropium compared to placebo when added to formoterol/budesonide combination (2 weeks)
B: All cause mortality at 3 years
C: Rate of healthcare utilisation based exacerbations of COPD
D: Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years (From day 30 to 4 years); Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years (From day 30 to 4 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicentre, Randomised, Double-Blind, Double Dummy, Parallel Group, 104-week Study to Compare the Effect of the Salmeterol/Fluticasone Propionate Combination Product (SERETIDE*) 50/500mcg Delivered Twice Daily Via the DISKUS*/ACCUHALER* Inhaler With Tiotropium Bromide 18 mcg Delivered Once Daily Via the HandiHaler Inhalation Device on the Rate of Health Care Utilisation Exacerbations in Subjects With Severe Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: This is a comparator study to assess the relative efficacy of the combination product fluticasone propionate/salmeterol 50/500 and tiotropium bromide on the rate of exacerbations of chronic obstructive pulmonary disease (COPD) over a two year study interval.


Options:
A: Trough Forced Expiratory Volume in one second (FEV1) response determined at the end of the 12- week treatment period (week 12)
B: Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) (Baseline to Endpoint (13 weeks)); Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1 (Baseline to Endpoint (13 weeks))
C: Rate of healthcare utilisation based exacerbations of COPD
D: Change in trough FEV1 after 12 weeks of treatment. (week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicentre, Randomised, Double-Blind, Double Dummy, Parallel Group, 104-week Study to Compare the Effect of the Salmeterol/Fluticasone Propionate Combination Product (SERETIDE*) 50/500mcg Delivered Twice Daily Via the DISKUS*/ACCUHALER* Inhaler With Tiotropium Bromide 18 mcg Delivered Once Daily Via the HandiHaler Inhalation Device on the Rate of Health Care Utilisation Exacerbations in Subjects With Severe Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: This is a comparator study to assess the relative efficacy of the combination product fluticasone propionate/salmeterol 50/500 and tiotropium bromide on the rate of exacerbations of chronic obstructive pulmonary disease (COPD) over a two year study interval.


Options:
A: Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years (From day 30 to 4 years); Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years (From day 30 to 4 years)
B: Rate of healthcare utilisation based exacerbations of COPD
C: First Occurrence of (Moderate or Severe) COPD Exacerbation (52 weeks)
D: Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year (52 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicentre, Randomised, Double-Blind, Double Dummy, Parallel Group, 104-week Study to Compare the Effect of the Salmeterol/Fluticasone Propionate Combination Product (SERETIDE*) 50/500mcg Delivered Twice Daily Via the DISKUS*/ACCUHALER* Inhaler With Tiotropium Bromide 18 mcg Delivered Once Daily Via the HandiHaler Inhalation Device on the Rate of Health Care Utilisation Exacerbations in Subjects With Severe Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: This is a comparator study to assess the relative efficacy of the combination product fluticasone propionate/salmeterol 50/500 and tiotropium bromide on the rate of exacerbations of chronic obstructive pulmonary disease (COPD) over a two year study interval.


Options:
A: All cause mortality at 3 years
B: Rate of healthcare utilisation based exacerbations of COPD
C: Pre-dose and 1-hour post-dose FEV1 over the 6 months treatment period
D: CRP (4 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impact of the Nutritional Fatty Acids During Pregnancy and Lactation for Early Human Adipose Tissue Development
Brief Summary: Pregnant and lactating women receive n-3 fatty acids starting from week 15 of gestation until 4 months post-partum (pp) in comparison to a control group, who only gets information about adequately healthy nutrition during pregnancy and lactation.

The amount of fat in newborns is measured through skinfold thickness, ultrasound, and magnetic resonance imaging (MRI).

It is hypothesised that a reduction in arachidonic acid intake and an increase of n-3 LC PUFAs (long chain polyunsaturated fatty acids) via supplements containing docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) could lead to less expansive fat tissue development in the first year of life.


Options:
A: amount of fat mass in the offspring (at birth, 6 weeks, 4 months, 1 year postpartum)
B: Growth; Body composition; Intestinal microbiota; Blood pressure; Plasma lipid profile; Insulin - glucose; Erythrocyte fatty acid composition; Ex vivo cytokine production; IGF-1 and IGFBP-3; Adipokines; Plasma CRP; Plasma IgE
C: Reduction in discharge rate of small-for-gestational age very low birth weight infants (6 months corrected age)
D: Cognitive development

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impact of the Nutritional Fatty Acids During Pregnancy and Lactation for Early Human Adipose Tissue Development
Brief Summary: Pregnant and lactating women receive n-3 fatty acids starting from week 15 of gestation until 4 months post-partum (pp) in comparison to a control group, who only gets information about adequately healthy nutrition during pregnancy and lactation.

The amount of fat in newborns is measured through skinfold thickness, ultrasound, and magnetic resonance imaging (MRI).

It is hypothesised that a reduction in arachidonic acid intake and an increase of n-3 LC PUFAs (long chain polyunsaturated fatty acids) via supplements containing docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) could lead to less expansive fat tissue development in the first year of life.


Options:
A: Persistent wheeze 0 to 3 years of age (3 years)
B: amount of fat mass in the offspring (at birth, 6 weeks, 4 months, 1 year postpartum)
C: Heart Rate (24, 32 and 36 weeks gestational age)
D: Occurrence of Early Preterm Birth (<34 weeks gestation) (Baseline to 34 Weeks); Occurrence of Early Preterm Birth (<34 weeks gestation) (Baseline to 34 weeks); Maternal and infant adverse and serious adverse events (Enrollment to 30 days past last birth)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impact of the Nutritional Fatty Acids During Pregnancy and Lactation for Early Human Adipose Tissue Development
Brief Summary: Pregnant and lactating women receive n-3 fatty acids starting from week 15 of gestation until 4 months post-partum (pp) in comparison to a control group, who only gets information about adequately healthy nutrition during pregnancy and lactation.

The amount of fat in newborns is measured through skinfold thickness, ultrasound, and magnetic resonance imaging (MRI).

It is hypothesised that a reduction in arachidonic acid intake and an increase of n-3 LC PUFAs (long chain polyunsaturated fatty acids) via supplements containing docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) could lead to less expansive fat tissue development in the first year of life.


Options:
A: Primary outcome is measuring of infant CNS maturity to 18 months of age (18 months)
B: Omega-3 fatty acid status in maternal and umbilical cord plasma (Weeks 20, 34 and 38 of pregnancy and at birth (in cord))
C: amount of fat mass in the offspring (at birth, 6 weeks, 4 months, 1 year postpartum)
D: percentage contribution of docosahexaenoic acid (DHA) to total phospholipid fatty acids in cord blood (labour)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impact of the Nutritional Fatty Acids During Pregnancy and Lactation for Early Human Adipose Tissue Development
Brief Summary: Pregnant and lactating women receive n-3 fatty acids starting from week 15 of gestation until 4 months post-partum (pp) in comparison to a control group, who only gets information about adequately healthy nutrition during pregnancy and lactation.

The amount of fat in newborns is measured through skinfold thickness, ultrasound, and magnetic resonance imaging (MRI).

It is hypothesised that a reduction in arachidonic acid intake and an increase of n-3 LC PUFAs (long chain polyunsaturated fatty acids) via supplements containing docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) could lead to less expansive fat tissue development in the first year of life.


Options:
A: Gestational diabetes (20 and 36 weeks pregnancy and 3 months post partum); Gestational diabetes (18 months postpartum)
B: Maternal gestational weight gain (40-42 weeks)
C: amount of fat mass in the offspring (at birth, 6 weeks, 4 months, 1 year postpartum)
D: Postpartum weight retention (no more than 1.5 years)

Answer: C