TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Haemorrhagia Postpartum: an Implementation Study on the NVOG Guidelines and MOET Instructions
Brief Summary: The objectives of this study is first to asses to what extent the guidelines of the Dutch Society of Obstetrics and Gynaecology (NVOG) and the MOET (Management of Obstetric and Emergencies and Trauma) instructions for haemorrhagia postpartum have been implemented in current care in the Dutch practice. Second to study barriers and facilitators for guideline adherence and to develop and test a tailored implementation strategy, based on these findings.


Options:
A: control of postpartum hemorrhage (within 20 minutes of administration)
B: actual care study: the primary outcome measure is the adherence to the quality indicators (derived from the NVOG guideline on HPP and the MOET instructions). (1 year); feasibility study: the primary outcome measure regarding effectiveness is the adherence to developed quality indicators. (1 years); barrier analysis (1 year)
C: Uterine Tone (at 10 minutes following administration of the first study drug)
D: Difference in differences: change in use of oxytocin for prevention of postpartum hemorrhage (Baseline, Midline (6 months), Endline (12 months))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Prospective Randomized Trial on the Use of Prothrombin Complex and Fresh Frozen Plasma in Patients With Intracerebral Hemorrhage Related to Vitamin K Antagonists
Brief Summary: Intracerebral haemorrhage (ICH) is the most feared complication in patients on vitamin K antagonists (VKA). VKA related ICH occurs 8-10 times more frequently and the mortality is 2 times higher than in non-anticoagulated patients. Mortality may rise up to 67%. The higher mortality rate may in part be due to the higher rate of haematoma expansion (HE) over a longer period after symptom onset. International guidelines recommend treatment of VKA-ICH with prothrombin complex (PCC) or fresh-frozen plasma (FFP) both in combination with Vitamin-K. But these recommendations are not based on randomized controlled trials. It is known that these drugs lower the INR, and thus it is assumed that normalization of coagulopathy may lead to haemostasis and reduction of HE. Safety and efficacy of these treatments have never been studied in a prospective controlled trial.

The investigators' questions are: How potent are PCC and FFP in normalization of the INR? What is the safety profile of each of these drugs?


Options:
A: INR ≤ 1.2 within 3 hours after start of drug infusion (3 hours)
B: ICH size (24 hours)
C: Modified Rankin Scale (mRS) (180 days)
D: Number of Study Subjects With Life-threatening Thromboembolic Complications (through day 4 after completion of study drug administration); Number of Subjects With Hematoma Growth Among Spot Sign Positive Subjects at 24 Hours. (From baseline to 24 hours); The Sensitivity of the Spot Sign for Predicting Hematoma Growth (Baseline head CT scan within 5 hours of stroke, followed by a CT angiogram. Hematoma growth determined by comparison with a head CT scan performed at 24 hours.); The Specificity of the Spot Sign for Predicting Hematoma Growth (Baseline head CT scan within 5 hours of stroke, followed by a CT angiogram. Hematoma growth determined by comparison with a head CT scan performed at 24 hours.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Clinical and Cost-effectiveness of Mindfulness Based Cognitive Therapy, Maintenance Antidepressant Medication and Its Combination in the Prevention of Relapse in Patients With Recurrent Depression
Brief Summary: The purpose of this study is to investigate the (cost)effectiveness of mindfulness based cognitive therapy (MBCT) compared to that of antidepressant medication, and its combination with regard to the prevention of relapse or recurrence in patients with recurrent depression.


Options:
A: N/A
B: Paid Work Hours at Week 12 (Week 12); Paid Work Hours at Week Baseline (Baseline)
C: Hamilton Depression Rating Scale (HDRS) - 24 Total Score (Week 10); Hamilton Depression Rating Scale (HDRS) - 24 Total Score (Baseline)
D: Relapse/recurrence of Major Depressive Episode (3, 6, 9, 12, 15 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Clinical and Cost-effectiveness of Mindfulness Based Cognitive Therapy, Maintenance Antidepressant Medication and Its Combination in the Prevention of Relapse in Patients With Recurrent Depression
Brief Summary: The purpose of this study is to investigate the (cost)effectiveness of mindfulness based cognitive therapy (MBCT) compared to that of antidepressant medication, and its combination with regard to the prevention of relapse or recurrence in patients with recurrent depression.


Options:
A: Number of Participants in Remission According to the Longitudinal Interval Follow-up Evaluation (LIFE) and the Hamilton Rating Scale for Depression (HRSD) (Through month 18 of treatment); Number of Participants in Recovery According to the LIFE and HRSD (Through 36 months of treatment); Number of Participants in Recurrence According to the LIFE and HRSD (Measured up to Month 36 from recovery)
B: Relapse/recurrence of Major Depressive Episode (3, 6, 9, 12, 15 months)
C: Stimulant drug use as measured by urine analysis (Treatment phase: 12 weeks (3 measurements a week), Follow Up Phase: 3 months (1 measuresment a month))
D: Hamilton Depression Rating Scale - Grid version (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Clinical and Cost-effectiveness of Mindfulness Based Cognitive Therapy, Maintenance Antidepressant Medication and Its Combination in the Prevention of Relapse in Patients With Recurrent Depression
Brief Summary: The purpose of this study is to investigate the (cost)effectiveness of mindfulness based cognitive therapy (MBCT) compared to that of antidepressant medication, and its combination with regard to the prevention of relapse or recurrence in patients with recurrent depression.


Options:
A: Relapse/recurrence of Major Depressive Episode (3, 6, 9, 12, 15 months)
B: Changes in Neuropsychiatric Inventory (24 weeks); Changes in Cornell's Depression Scale (24 weeks); Changes in UPDRS subscale (24 weeks)
C: Number of patients who fully discontinued their antidepressant medication after 6 months. (6 months)
D: Hamilton Anxiety Rating Scale (56 weeks); Penn State Worry Questionnaire (56 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-week Treatment, Randomized, Double-blind, Placebo-controlled, With Open-label Tiotropium, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Glycopyrronium Bromide (NVA237) in Patients With Chronic Obstructive Pulmonary Disease
Brief Summary: This study was designed to investigate the 1 year efficacy and safety of the 50 µg once daily (od) dose of glycopyrronium bromide (NVA237) in patients with moderate to severe chronic obstructive pulmonary disease.


Options:
A: FEV1 AUC 0-12 on Day 7 (Day 7)
B: Change From Baseline Trough in 24-hour Weighted-mean FEV1 on Treatment Day 84 (Baseline and Day 84)
C: Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (Week 12)
D: Number of Participants With Death (Both on and Off Treatment) Due to Any Cause, Time up to or on the Pre-determined Common End Date (From the date of randomization until date of death due to any cause (average of 2 study years))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Study of the Effect of Maintenance Therapy With Bevacizumab + Capecitabine Versus Bevacizumab Alone on Progression-free Survival in Patients With HER2-negative Metastatic Breast Cancer That Has Not Progressed During First-line Docetaxel Plus Bevacizumab Therapy
Brief Summary: This randomized study will compare maintenance therapy with Avastin (bevacizumab) + Xeloda (capecitabine) versus Avastin alone, in patients with HER2-negative metastatic breast cancer who have not progressed during first-line therapy with docetaxel + Avastin. Eligible patients will receive up to 6 x 3 week cycles of treatment with Avastin (15 mg/mg IV on Day 1 of each cycle) + docetaxel (75-100 mg/m2 IV on Day 1 of each cycle). Those patients who do not progress will be randomized to 3 week cycles of either a) Avastin (15 mg/kg IV on Day 1 of each cycle) + Xeloda (1000 mg/m2 po bid on Days 1-14 of each cycle) or b) Avastin alone. Study treatment will continue until disease progression, unacceptable toxicity, patient request for withdrawal or end of study, and the target sample size is 100-500 individuals.


Options:
A: Disease-free survival (DFS) at 5 years
B: Percentage of Participants With Disease Progression or Death (Maintenance Phase Data Cutoff October 4, 2013) (Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years); Progression Free Survival (Maintenance Phase Data Cutoff October 4, 2013) (Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years)
C: Pathologic complete response
D: Overall Survival (From date of randomization until death from any cause)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing Physical Activity Adherence After Breast Cancer Diagnosis (BEAT Cancer Study II)
Brief Summary: The purpose of the study is to compare the effects of one exercise/counseling protocol with usual care on long term exercise adherence and on changes in health related outcomes after breast cancer diagnosis.


Options:
A: QoL: Physical Well-Being (FACT-L) (assessed after 12 weeks of enrolement); General Fatigue (MFI) (assessed after 12 weeks of enrolement)
B: Cardiorespiratory Fitness will be determined using a incremental treadmill test with 12-lead ECG monitoring. (6 months)
C: Feasibility of a planned Nordic life style intervention (Five years)
D: change in physical activity (baseline to 3 months); change in physical activity (3 mos to 6 months); change in physical activity (6 months to 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing Physical Activity Adherence After Breast Cancer Diagnosis (BEAT Cancer Study II)
Brief Summary: The purpose of the study is to compare the effects of one exercise/counseling protocol with usual care on long term exercise adherence and on changes in health related outcomes after breast cancer diagnosis.


Options:
A: Changes in body composition, waist circumference, blood pressure, and serum levels of insulin, glucose, lipids, C-reactive protein, and HbA1c (At week 16); Improvement of physical fitness, cardiorespiratory fitness, and muscle strength (At week 16); Feasibility of a supervised exercise program for cancer survivors (At week 16); Maintain positive benefits of an exercise intervention (12 weeks post-intervention)
B: Menopausal symptoms (6 months)
C: change in physical activity (baseline to 3 months); change in physical activity (3 mos to 6 months); change in physical activity (6 months to 12 months)
D: quality of life, fatigue, and body weight (baseline, 6 months, 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Head-to-Head, Single-Blind Study to Compare the Efficacy and Safety of Subcutaneous Abatacept Versus Subcutaneous Adalimumab, Both With Background Methotrexate, in Biologic-Naive Subjects With Rheumatoid Arthritis
Brief Summary: The purpose of this study is demonstrate that subcutaneous abatacept is non-inferior (no worse than) to subcutaneous adalimumab in the treatment of subjects with rheumatoid arthritis who are biologic naive


Options:
A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 (Week 12)
B: Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 16 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 16); Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 8 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 8); Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 4 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 4); Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 2 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 2); Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 1 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 1)
C: 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)
D: Percentage of Participants Who Responded to ≥ 6 of 12 Anti-pneumococcal Antibody Serotypes (Baseline (Week 3) and Week 8 (5 weeks post-vaccination))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Head-to-Head, Single-Blind Study to Compare the Efficacy and Safety of Subcutaneous Abatacept Versus Subcutaneous Adalimumab, Both With Background Methotrexate, in Biologic-Naive Subjects With Rheumatoid Arthritis
Brief Summary: The purpose of this study is demonstrate that subcutaneous abatacept is non-inferior (no worse than) to subcutaneous adalimumab in the treatment of subjects with rheumatoid arthritis who are biologic naive


Options:
A: Percent of Participants Achieving an American College of Rheumatology (ACR) 20% Response Rate (At 12 Weeks)
B: Mean 48-week Change in DAS28 (48 weeks after baseline assessment)
C: 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)
D: 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)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Head-to-Head, Single-Blind Study to Compare the Efficacy and Safety of Subcutaneous Abatacept Versus Subcutaneous Adalimumab, Both With Background Methotrexate, in Biologic-Naive Subjects With Rheumatoid Arthritis
Brief Summary: The purpose of this study is demonstrate that subcutaneous abatacept is non-inferior (no worse than) to subcutaneous adalimumab in the treatment of subjects with rheumatoid arthritis who are biologic naive


Options:
A: Proportion of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14 (Week 14)
B: Change in disease activity. (6 months)
C: 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)
D: 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)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Head-to-Head, Single-Blind Study to Compare the Efficacy and Safety of Subcutaneous Abatacept Versus Subcutaneous Adalimumab, Both With Background Methotrexate, in Biologic-Naive Subjects With Rheumatoid Arthritis
Brief Summary: The purpose of this study is demonstrate that subcutaneous abatacept is non-inferior (no worse than) to subcutaneous adalimumab in the treatment of subjects with rheumatoid arthritis who are biologic naive


Options:
A: Percentage of patients with ACR 20 response (Week 24)
B: 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)
C: Disease Activity Score Erythrocyte Sedimentation Rate(DAS28-ESR) (Change of the Mean of DAS28-ESR between weeks 48 - 102.)
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: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Head-to-Head, Single-Blind Study to Compare the Efficacy and Safety of Subcutaneous Abatacept Versus Subcutaneous Adalimumab, Both With Background Methotrexate, in Biologic-Naive Subjects With Rheumatoid Arthritis
Brief Summary: The purpose of this study is demonstrate that subcutaneous abatacept is non-inferior (no worse than) to subcutaneous adalimumab in the treatment of subjects with rheumatoid arthritis who are biologic naive


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: Percentage of Participants Achieving 28 Joint Disease Activity Score (DAS28) Less Than or Equal to (≤) 3.2 at Week 88 (Week 88)
C: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 (Month 6); Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3 (Baseline, Month 3); Percentage of Participants 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: Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response at Week 24 (Week 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Inpatient Attending Physician Rotation Duration Study
Brief Summary: The investigators are testing the effects of a change in teaching attending physicians' rotations (from 4- to 2-week blocks) on patient outcomes (unplanned urgent visits to the health care system, inpatient mortality, and length-of-stay), the educational experiences of residents and medical students and on the quality of the professional lives of the attending physicians.


Options:
A: change in self reported Stress symptoms (Baseline, 1 month, 3 months)
B: Patients' unplanned urgent visits to the health care system. (30 days after discharge)
C: Stress Mindset Measure - General (SMM-G) (Change from Baseline SMM-G score at 6-months post CAR Training)
D: Perceived Stress Scale (PSS) (Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitive Remediation in the Schizophrenia Trials Network
Brief Summary: This study will test whether a cognitive remediation program to treat people with schizophrenia can be successfully implemented in a network of research clinics.


Options:
A: Cognitive performance, as measured by a neuropsychological battery (Measured at baseline, Weeks 8 and Month 6, 12, 18, and 24 follow-up)
B: Change from Baseline Social Cognition at 6 months (Baseline (Intake)/6 months follow-up after trianing completion)
C: Cognitive Function Measured by MCCB Composite Score (4-6 month period); Cognitive Function as Measured by the University of California, San Diego, Performance-Based Skills Assessment-Brief (UPSA-B) Scale (4-6 month period)
D: Feasibility of a multisite trial using cognitive remediation (Measured at post-treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Inadequately Controlled on Inhaled Corticosteroids
Brief Summary: This is a randomized, double-blind, placebo-controlled study to evaluate the effects of lebrikizumab in patients with asthma who remain inadequately controlled while on chronic therapy with inhaled corticosteroids (ICS).


Options:
A: Incidence of Adverse Events (Days 0 - 150); Incidence of Serious Adverse Events (Days 0 - 150)
B: The primary objective is to evaluate the efficacy of AMG 317 compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) symptom scores from baseline to week 12. (12 weeks)
C: Change in forced expiratory volume in 1 second (FEV1) (From baseline to Week 12)
D: Integrated Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline) (Baseline, 12 Months)

Answer: C