TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Multi-centre, Open-label, follow-on Study to CDP870-027, to Assess the Efficacy and Safety of Lyophilized CDP870 an Engineered Human Anti-TNF PEG Conjugate, as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and Preventing Structural Damage in Patients With Active Rheumatoid Arthritis
Brief Summary: An open ended study in which patients who completed the double-blind study CDP870-027 \[NCT00152386\] are given Certolizumab Pegol (CZP) and assessed for signs and symptoms of Rheumatoid Arthritis (RA).


Options:
A: Number of Participants With American College of Rheumatology 20 Response at Week 24 (Week 24)
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 28 Joint Disease Activity Score (DAS28) Less Than or Equal to (≤) 3.2 at Week 88 (Week 88)
D: Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years (From first dose of CZP to the end of the open-label study (approximately 7 years)); Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years (From first dose of CZP to the end of the open-label study (approximately 7 years)); Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study (From Entry Visit (Week 0) to the end of the study (approximately 6.5 years))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Multi-centre, Open-label, follow-on Study to CDP870-027, to Assess the Efficacy and Safety of Lyophilized CDP870 an Engineered Human Anti-TNF PEG Conjugate, as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and Preventing Structural Damage in Patients With Active Rheumatoid Arthritis
Brief Summary: An open ended study in which patients who completed the double-blind study CDP870-027 \[NCT00152386\] are given Certolizumab Pegol (CZP) and assessed for signs and symptoms of Rheumatoid Arthritis (RA).


Options:
A: American College of Rheumatology 20% (ACR20) Response at Week 12 (Baseline, Week 12)
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: Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years (From first dose of CZP to the end of the open-label study (approximately 7 years)); Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years (From first dose of CZP to the end of the open-label study (approximately 7 years)); Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study (From Entry Visit (Week 0) to the end of the study (approximately 6.5 years))
D: Number of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24 (Week 24); Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 52 (Baseline and Week 52)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Multi-centre, Open-label, follow-on Study to CDP870-027, to Assess the Efficacy and Safety of Lyophilized CDP870 an Engineered Human Anti-TNF PEG Conjugate, as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and Preventing Structural Damage in Patients With Active Rheumatoid Arthritis
Brief Summary: An open ended study in which patients who completed the double-blind study CDP870-027 \[NCT00152386\] are given Certolizumab Pegol (CZP) and assessed for signs and symptoms of Rheumatoid Arthritis (RA).


Options:
A: Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years (From first dose of CZP to the end of the open-label study (approximately 7 years)); Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years (From first dose of CZP to the end of the open-label study (approximately 7 years)); Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study (From Entry Visit (Week 0) to the end of the study (approximately 6.5 years))
B: Percentage of patients with ACR 20 response (Week 24)
C: Number of Participants Meeting the American College of Rheumatology 20 (ACR 20) Response at Week 16 (Week 16)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Multi-centre, Open-label, follow-on Study to CDP870-027, to Assess the Efficacy and Safety of Lyophilized CDP870 an Engineered Human Anti-TNF PEG Conjugate, as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and Preventing Structural Damage in Patients With Active Rheumatoid Arthritis
Brief Summary: An open ended study in which patients who completed the double-blind study CDP870-027 \[NCT00152386\] are given Certolizumab Pegol (CZP) and assessed for signs and symptoms of Rheumatoid Arthritis (RA).


Options:
A: American college of Rheumatolofy (ACR)-20 responder rate at Week 24
B: Disease Activity Score Erythrocyte Sedimentation Rate(DAS28-ESR) (Change of the Mean of DAS28-ESR between weeks 48 - 102.)
C: Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years (From first dose of CZP to the end of the open-label study (approximately 7 years)); Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years (From first dose of CZP to the end of the open-label study (approximately 7 years)); Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study (From Entry Visit (Week 0) to the end of the study (approximately 6.5 years))
D: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 (Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Therapeutic Confirmatory, Open-label, Multi-center, Randomized 2 Parallel Groups, Community-based Trial Studying the Efficacy and Safety of Levetiracetam (1000 to 3000 mg/Day Oral Tablets 250-500 mg b.i.d.) Compared to Sodium Valproate (1000 to 2000 mg/Day Oral ER Tablets 300-500 mg b.i.d.) and Carbamazepine (600 to 1600 mg/Day Oral CR Tablets 200-400 mg b.i.d.) as Monotherapy in Subjects With Newly Diagnosed Epilepsy.
Brief Summary: Study N01175 was to compare overall effectiveness (efficacy and safety) of levetiracetam (LEV) versus the 2 older antiepileptic drugs (AEDs), sodium valproate extended release (VPA-ER) and carbamazepine controlled release (CBZ-CR) in the treatment of subjects with newly diagnosed epilepsy.


Options:
A: 58-week Retention Rate Measured by the Number of Drop Outs Due to Adverse Events or Seizures From Day 1 of Treatment (58 weeks)
B: N/A
C: Time to withdrawal from study medication (starting at V1) as a measure of combined efficacy and safety (Visit 1 to End of Study (approximately 52 weeks))
D: The primary outcome parameter is the time to first seizure during the double blind phase of the study. The statistical evaluation will analyze if there is a significant difference in the proportion of patients being seizure free between both medications.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Therapeutic Confirmatory, Open-label, Multi-center, Randomized 2 Parallel Groups, Community-based Trial Studying the Efficacy and Safety of Levetiracetam (1000 to 3000 mg/Day Oral Tablets 250-500 mg b.i.d.) Compared to Sodium Valproate (1000 to 2000 mg/Day Oral ER Tablets 300-500 mg b.i.d.) and Carbamazepine (600 to 1600 mg/Day Oral CR Tablets 200-400 mg b.i.d.) as Monotherapy in Subjects With Newly Diagnosed Epilepsy.
Brief Summary: Study N01175 was to compare overall effectiveness (efficacy and safety) of levetiracetam (LEV) versus the 2 older antiepileptic drugs (AEDs), sodium valproate extended release (VPA-ER) and carbamazepine controlled release (CBZ-CR) in the treatment of subjects with newly diagnosed epilepsy.


Options:
A: Rate of seizure-free patients (in the first 6 weeks of the trial)
B: 58-week Retention Rate Measured by the Number of Drop Outs Due to Adverse Events or Seizures From Day 1 of Treatment (58 weeks)
C: Assessment and comparative analysis of initial and follow-up Neuropsychological evaluation in both treated groups. (Levetiracetam and Carbamazepine) (52 weeks)
D: Time to withdrawal from study medication (starting at V1) as a measure of combined efficacy and safety (Visit 1 to End of Study (approximately 52 weeks))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Therapeutic Confirmatory, Open-label, Multi-center, Randomized 2 Parallel Groups, Community-based Trial Studying the Efficacy and Safety of Levetiracetam (1000 to 3000 mg/Day Oral Tablets 250-500 mg b.i.d.) Compared to Sodium Valproate (1000 to 2000 mg/Day Oral ER Tablets 300-500 mg b.i.d.) and Carbamazepine (600 to 1600 mg/Day Oral CR Tablets 200-400 mg b.i.d.) as Monotherapy in Subjects With Newly Diagnosed Epilepsy.
Brief Summary: Study N01175 was to compare overall effectiveness (efficacy and safety) of levetiracetam (LEV) versus the 2 older antiepileptic drugs (AEDs), sodium valproate extended release (VPA-ER) and carbamazepine controlled release (CBZ-CR) in the treatment of subjects with newly diagnosed epilepsy.


Options:
A: Time to withdrawal from study medication (starting at V1) as a measure of combined efficacy and safety (Visit 1 to End of Study (approximately 52 weeks))
B: 58-week Retention Rate Measured by the Number of Drop Outs Due to Adverse Events or Seizures From Day 1 of Treatment (58 weeks)
C: The primary outcome parameter is the time to first seizure during the double blind phase of the study. The statistical evaluation will analyze if there is a significant difference in the proportion of patients being seizure free between both medications.
D: The primary efficacy variable will be the proportion of subjects in the PP set who are seizure free for the entire 26-week Evaluation Period at the last received dose level. (26 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-blind, Randomized, Placebo-controlled, 3 Parallel Groups, Dose-ranging Trial Evaluating the Efficacy and Safety of Ucb 34714 Used as Adjunctive Treatment at Doses of 50 and 150 mg/Day in b.i.d. Administration (Oral Capsules of 25 mg) for a Maximum of 12 Weeks in Subjects From 16 to 65 Years With Refractory Epilepsy Suffering From Partial Onset Seizures Whether or Not Secondarily Generalized
Brief Summary: This trial will evaluate the efficacy and safety of brivaracetam (at doses of 50 and 150 mg/day in twice a day administration) as add on therapy in subjects with focal epilepsy


Options:
A: Partial Onset Seizure Frequency Per Week During the 7-week Treatment Period (During the 7-week Treatment Period)
B: Time to Next Seizure (Per Clinical Observation With Electroencephalogram [EEG] Confirmation) or Rescue Medication (During the Treatment Period (Day 1) until Safety Follow-Up Visit (Day 2))
C: Partial onset seizure frequency (Type I) per week over the 7-week maintenance period (7-week maintenance period)
D: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) (From Entry Visit (Month 0) until the Last Visit (up to 84 months)); Percentage of Participants Who Withdrew Due to Adverse Events (AEs) (From Entry Visit (Month 0) until the Last Visit (up to 84 months)); Percentage of Participants With at Least One Serious Adverse Event (SAE) (From Entry Visit (Month 0) until the Last Visit (up to 84 months))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-blind, Randomized, Placebo-controlled, 3 Parallel Groups, Dose-ranging Trial Evaluating the Efficacy and Safety of Ucb 34714 Used as Adjunctive Treatment at Doses of 50 and 150 mg/Day in b.i.d. Administration (Oral Capsules of 25 mg) for a Maximum of 12 Weeks in Subjects From 16 to 65 Years With Refractory Epilepsy Suffering From Partial Onset Seizures Whether or Not Secondarily Generalized
Brief Summary: This trial will evaluate the efficacy and safety of brivaracetam (at doses of 50 and 150 mg/day in twice a day administration) as add on therapy in subjects with focal epilepsy


Options:
A: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) (From Entry Visit (Month 0) until the Last Visit (up to 84 months)); Percentage of Participants Who Withdrew Due to Adverse Events (AEs) (From Entry Visit (Month 0) until the Last Visit (up to 84 months)); Percentage of Participants With at Least One Serious Adverse Event (SAE) (From Entry Visit (Month 0) until the Last Visit (up to 84 months))
B: Partial onset seizure frequency (Type I) per week over the 7-week maintenance period (7-week maintenance period)
C: Percentage of Subjects With at Least One Adverse Event During the 16-week Treatment Period (Week 2 to the end of the Treatment Period (Week 16)); Partial Onset Seizure (Type I) Frequency Per Week Over the 16-week Treatment Period (Baseline (Week 0) to the end of the Treatment Period (Week 16))
D: Percent Reduction Over Placebo for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration (12 week Treatment Period); 50% Responder Rate for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration (Baseline to 12 week Treatment Period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-blind, Randomized, Placebo-controlled, 3 Parallel Groups, Dose-ranging Trial Evaluating the Efficacy and Safety of Ucb 34714 Used as Adjunctive Treatment at Doses of 50 and 150 mg/Day in b.i.d. Administration (Oral Capsules of 25 mg) for a Maximum of 12 Weeks in Subjects From 16 to 65 Years With Refractory Epilepsy Suffering From Partial Onset Seizures Whether or Not Secondarily Generalized
Brief Summary: This trial will evaluate the efficacy and safety of brivaracetam (at doses of 50 and 150 mg/day in twice a day administration) as add on therapy in subjects with focal epilepsy


Options:
A: Percent Change From Baseline in 28-day Seizure Frequency at Week 21. (6 weeks Baseline, 21 weeks through End of MP for 27 weeks)
B: Partial onset seizure frequency (Type I) per week over the 7-week maintenance period (7-week maintenance period)
C: Log Transformed (Loge) 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Treatment Phase (Week 0 to Week 14)
D: Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period (Baseline to 12-week Treatment Period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Controlled Trial of Risperidone and Divalproex Sodium With MRI Assessment of Affected Circuitry in Pre and Post Treatment in Pediatric Bipolar
Brief Summary: The study is to examine the null hypothesis that risperidone and divalproex sodium are equally effective in treating/stabilizing pediatric bipolar disorder.


Options:
A: To test the superiority of olanzapine compared with divalproex in improving overall manic symptomatology in patients with mild to moderate; mania associated with bipolar I disorder, as measured by reductions on the Young Mania Rating Scale (YMRS) total score from baseline to the endpoint of Study Period II (3-week acute therapy phase).
B: Change from baseline to the final evaluation for the MRS from the SADS-C for the intent-to-treat dataset.
C: Young Mania Rating Scale (YMRS) (Six week study with assessment at baseline and end of the study (at the end of 6 weeks or earlier if they ended the study before 6 week end point).)
D: Safety outcome measures

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: There is an increasing incidence of overweight children in Germany, due to a lack of physical activity.

The aim of this study is to improve physical fitness and activity in school children. Two classes in different schools are provided with additional sport lessons over a period of one year.


Options:
A: Change in minutes spent in moderate to vigorous physical activity in after school programs from baseline to end of intervention (7 months) and 1 year after end of intervention. (Baseline, end of intervention (7 months), 1 year after intervention)
B: Change in Demographic data (Evaluation at three time points: 0 months, 2 months and 8 months); Goal setting tool (Evaluation at three time points: 0 months, 2 months and 8 months); Changes in 24-hour dietary intake recall (Evaluation at three time points: 0 months, 2 months and 8 months); Changes in 3-day dietary intake record (Evaluation at three time points: 0 months, 2 months and 8 months); Changes in 24-hour physical activity recall (Evaluation at three time points: 0 months, 2 months and 8 months); Changes in 3-day physical activity record (Evaluation at three time points: 0 months, 2 months and 8 months); Changes in Anthropometric measurements (Evaluation at three time points: 0 months, 2 months and 8 months); Changes in Social Cognitive Theory (SCT) variables (Evaluation at three time points: 0 months, 2 months and 8 months); Changes in blood pressure (BP) measurements (Evaluation at three time points: 0 months, 2 months and 8 months)
C: Fitness (Day 0, Day 120)
D: Improvement of maximal oxygen uptake

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: There is an increasing incidence of overweight children in Germany, due to a lack of physical activity.

The aim of this study is to improve physical fitness and activity in school children. Two classes in different schools are provided with additional sport lessons over a period of one year.


Options:
A: Total Body Bone Mineral Density (TBBMD) (Baseline, 1 year, and 2 years)
B: To evaluate and compare in overweight children the effectiveness of the following interventions: a parent-centered dietary modification program; a physical activity skill development program; and a parent-centered dietary modification + physical activity skill development program.
C: Cardiovascular disease risk factors (obesity, blood pressure, blood lipid & lipoprotein) (6 Months)
D: Improvement of maximal oxygen uptake

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: There is an increasing incidence of overweight children in Germany, due to a lack of physical activity.

The aim of this study is to improve physical fitness and activity in school children. Two classes in different schools are provided with additional sport lessons over a period of one year.


Options:
A: Body Mass Index score(BMI sds) at the age 6 years to monitor the effectiveness of the intervention (5 years)
B: Improvement of maximal oxygen uptake
C: BMI change at 6 month post assessment (Baseline and 6 month post assessment); BMI change at 1 year post assessment (Baseline to 1 year post assessment)
D: Body fat percentage (One year (interim analysis))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Three Months of Aerobic Exercise Training on Exercise Capacity and Peripheral Maladaptations in Patients With Severe Chronic Heart Failure (NYHA III b)
Brief Summary: Patients with heart failure are limited in their exercise capacity due to skeletal muscle alteration and an impairment of peripheral perfusion. Regular physical exercise training has been shown to partially correct these peripheral maladaptations in patients with stable heart failure, which was associated with an improvement in exercise capacity. However, it is unknown so far, whether regular physical activity also exerts beneficial effects in patients with severe chronic heart failure.

Aim of the trial is therefore to assess the effects of aerobic exercise training on exercise capacity, muscle maladaptations and peripheral perfusion in patients with severe chronic heart failure according to NYHA class III b.


Options:
A: Peak exercise capacity (16 weeks)
B: Composite of all-cause mortality and all-cause hospitalization rates (measured at Year 3) (Measured as events occur during the lifespan of the trial.)
C: Peak oxygen uptake
D: HF-specific quality of life (baseline, midpoint, endpoint, 6mo); functional capacity (baseline and endpoint); Walking Test (baseline, midpoint, endpoint)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Three Months of Aerobic Exercise Training on Exercise Capacity and Peripheral Maladaptations in Patients With Severe Chronic Heart Failure (NYHA III b)
Brief Summary: Patients with heart failure are limited in their exercise capacity due to skeletal muscle alteration and an impairment of peripheral perfusion. Regular physical exercise training has been shown to partially correct these peripheral maladaptations in patients with stable heart failure, which was associated with an improvement in exercise capacity. However, it is unknown so far, whether regular physical activity also exerts beneficial effects in patients with severe chronic heart failure.

Aim of the trial is therefore to assess the effects of aerobic exercise training on exercise capacity, muscle maladaptations and peripheral perfusion in patients with severe chronic heart failure according to NYHA class III b.


Options:
A: 6 Minute Walk Test (up to 3 months)
B: Peak oxygen uptake
C: functional capacity (6 months)
D: functional capacity (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Adjunctive Galantamine for Treatment of Cognitive Impairments in Patients With Schizophrenia
Brief Summary: The purpose of this study is to examine whether adjunctive galantamine is effective in the treatment of cognitive impairments in patients with schizophrenia.


Options:
A: Overall Cognitive Improvement Z-score (12 weeks)
B: 7 day point prevalence of cigarette abstinence (End of trial (week 10))
C: The Fagerstrom Test for Nicotine Dependence, expired CO level, and urine cotinine will be used to determine if bupropion SR, when used as an adjunct to antipsychotic medication, is superior to placebo for helping patients with schizophrenia improve their (Expired CO weekly, Fagerstrom baseline and end of study, Urine cotinine baseline, week 2 and week 8); Neuropsychological testing will be used to determine the effects of smoking cessation on patient's attention and memory function. (Beginning and end of study)
D: To examine the effects of varenicline treatment used concomitantly with antipsychotic medications, on cognitive dysfunction in people with schizophrenia. (8 weeks)

Answer: A