TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: STAMPEDE: Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently
Brief Summary: The aim of the study is to compare the relative clinical outcomes between advanced medical therapy alone or advanced medical therapy combined with bariatric surgery \[either Roux-en-Y gastric bypass (RYGBP) or laparoscopic sleeve gastrectomy\] in patients with type 2 diabetes and a body mass index (BMI) between 27 and 43 kg/m2. The study will examine the short and long term effects of each intervention on biochemical resolution of diabetes, diabetic complications, and end-organ damage.


Options:
A: Measure sugar levels, HbA1c levels, and medication needed. OGTT, MGTT. (1st, 2nd, 3rd, 4th, 5th, 6th, 9th, 12th months)
B: Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6%. (1 year); Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6% With no Diabetes Medications (1 year)
C: Total Weight Change From Baseline at 12 Weeks in kg (12 weeks)
D: BMI (5 y); Metabolic normalization (5y); Gastro-intestinal side effects (5y)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Bosentan on Exercise Capacity at High Altitude
Brief Summary: This study is to determine whether bosentan will alter exercise capacity after rapid ascent to high altitude.

We hypothesize that bosentan administration will improve arterial oxygenation and exercise capacity.


Options:
A: Time to tumor progression (TTP) or death (progression free survival) after initiation of treatment. Tumor progression is defined per RECIST criteria. (6 weekly)
B: Exercise Capacity; Pulmonary artery systolic pressure
C: Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Core (6 months); Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Extension (72 months); Change From Baseline of Six Minute Walk Test - Total Distance Walked at Different Time Periods (Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)); Change From Baseline of Six Minute Walk Test - Number of Stops at Different Time Periods (Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)); Change From Baseline of Six Minute Walk Test - Total Duration of Stops at Different Time Periods (Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24))
D: exercise capacity (Baseline to end of study); cardiac hemodynamics (Baseline to end of study)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Bosentan on Exercise Capacity at High Altitude
Brief Summary: This study is to determine whether bosentan will alter exercise capacity after rapid ascent to high altitude.

We hypothesize that bosentan administration will improve arterial oxygenation and exercise capacity.


Options:
A: Change from baseline to End-of-Study in 6-minute walk distance.
B: The primary endpoint is a fall in pulmonary vascular resistance (PVR) of 20% over 16 weeks. (16 weeks)
C: Number of Participants With First Adjudicated Clinical Failure (CF) Event, Death, Hospitalisation for Worsening PAH, Disease Progression, Unsatisfactory Long-term Clinical Response, All Through FAV (From Baseline up to the Final Assessment Visit (FAV) (average of 609 days))
D: Exercise Capacity; Pulmonary artery systolic pressure

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of NIPPV to Increase Survival Without Bronchopulmonary Dysplasia in Extremely Low Birth Weight Infants
Brief Summary: The machines and oxygen used to help very premature babies breathe can have side-effects, such as bronchopulmonary dysplasia (BPD). Infants with BPD get more complications (a higher death rate, a longer time in intensive care and on assisted ventilation, more hospital readmissions in the first year of life, and more learning problems) than infants who do not develop BPD. Doctors try to remove the tube in the wind-pipe that links the baby to the breathing machine as soon as possible. However, small babies get tired, and still require help to breathe. One of the standard and common techniques to help them breathe without a tube in the wind-pipe is to use simple pressure support, nasal continuous positive airway pressure or nCPAP. This supports breathing a little, but it is often not enough to prevent the need to go back on the breathing machine.

Nasal intermittent positive pressure ventilation (NIPPV) is similar to nCPAP, but also gives some breaths, or extra support, to babies through a small tube in the nose. NIPPV is safe and effective, and already in use as an alternate "standard" therapy.

The main research question: After being weaned from the breathing machine, is NIPPV better than nCPAP in preventing BPD in premature babies weighing 999 grams or less at birth?


Options:
A: combined rate of mortality and neurodevelopmental disability in survivors at a corrected age of 18 months. (corrected age of 18 months)
B: Duration of NIV Support (10 days); Failure of NIV Support (10 days)
C: Composite of survival to 36 weeks gestational age, free of moderate-severe bronchopulmonary dysplasia (36 weeks gestational age)
D: Extubation failure (apnea rate and respiratory failure.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of NIPPV to Increase Survival Without Bronchopulmonary Dysplasia in Extremely Low Birth Weight Infants
Brief Summary: The machines and oxygen used to help very premature babies breathe can have side-effects, such as bronchopulmonary dysplasia (BPD). Infants with BPD get more complications (a higher death rate, a longer time in intensive care and on assisted ventilation, more hospital readmissions in the first year of life, and more learning problems) than infants who do not develop BPD. Doctors try to remove the tube in the wind-pipe that links the baby to the breathing machine as soon as possible. However, small babies get tired, and still require help to breathe. One of the standard and common techniques to help them breathe without a tube in the wind-pipe is to use simple pressure support, nasal continuous positive airway pressure or nCPAP. This supports breathing a little, but it is often not enough to prevent the need to go back on the breathing machine.

Nasal intermittent positive pressure ventilation (NIPPV) is similar to nCPAP, but also gives some breaths, or extra support, to babies through a small tube in the nose. NIPPV is safe and effective, and already in use as an alternate "standard" therapy.

The main research question: After being weaned from the breathing machine, is NIPPV better than nCPAP in preventing BPD in premature babies weighing 999 grams or less at birth?


Options:
A: Extubation failure (apnea rate and respiratory failure.)
B: Composite of survival to 36 weeks gestational age, free of moderate-severe bronchopulmonary dysplasia (36 weeks gestational age)
C: Trigger Delay (last 5-min of each 15-min trial)
D: Failure of assignmed non-invasive mode post randomization to NIHFV or BP-CPAP (72 hours)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of NIPPV to Increase Survival Without Bronchopulmonary Dysplasia in Extremely Low Birth Weight Infants
Brief Summary: The machines and oxygen used to help very premature babies breathe can have side-effects, such as bronchopulmonary dysplasia (BPD). Infants with BPD get more complications (a higher death rate, a longer time in intensive care and on assisted ventilation, more hospital readmissions in the first year of life, and more learning problems) than infants who do not develop BPD. Doctors try to remove the tube in the wind-pipe that links the baby to the breathing machine as soon as possible. However, small babies get tired, and still require help to breathe. One of the standard and common techniques to help them breathe without a tube in the wind-pipe is to use simple pressure support, nasal continuous positive airway pressure or nCPAP. This supports breathing a little, but it is often not enough to prevent the need to go back on the breathing machine.

Nasal intermittent positive pressure ventilation (NIPPV) is similar to nCPAP, but also gives some breaths, or extra support, to babies through a small tube in the nose. NIPPV is safe and effective, and already in use as an alternate "standard" therapy.

The main research question: After being weaned from the breathing machine, is NIPPV better than nCPAP in preventing BPD in premature babies weighing 999 grams or less at birth?


Options:
A: Need for Endotracheal Ventilation in the First 72 hs of Life (first 72 hs of life); Mechanical Ventilation Within the First 72h of Life in the Two Study Groups.(NIPPV vs NCPAP) (first 3 days of life(72hours))
B: The rate of successful extubation with either mode of NCPAP (Day 7 post primary extubation)
C: Incidence of Mechanical Ventilation via endotracheal tube after non-invasive respiratory support. (At 7 days after non-invasive respiratorynsupport.)
D: Composite of survival to 36 weeks gestational age, free of moderate-severe bronchopulmonary dysplasia (36 weeks gestational age)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of NIPPV to Increase Survival Without Bronchopulmonary Dysplasia in Extremely Low Birth Weight Infants
Brief Summary: The machines and oxygen used to help very premature babies breathe can have side-effects, such as bronchopulmonary dysplasia (BPD). Infants with BPD get more complications (a higher death rate, a longer time in intensive care and on assisted ventilation, more hospital readmissions in the first year of life, and more learning problems) than infants who do not develop BPD. Doctors try to remove the tube in the wind-pipe that links the baby to the breathing machine as soon as possible. However, small babies get tired, and still require help to breathe. One of the standard and common techniques to help them breathe without a tube in the wind-pipe is to use simple pressure support, nasal continuous positive airway pressure or nCPAP. This supports breathing a little, but it is often not enough to prevent the need to go back on the breathing machine.

Nasal intermittent positive pressure ventilation (NIPPV) is similar to nCPAP, but also gives some breaths, or extra support, to babies through a small tube in the nose. NIPPV is safe and effective, and already in use as an alternate "standard" therapy.

The main research question: After being weaned from the breathing machine, is NIPPV better than nCPAP in preventing BPD in premature babies weighing 999 grams or less at birth?


Options:
A: Need for Endotracheal Ventilation in the First 72 hs of Life (first 72 hs of life); Mechanical Ventilation Within the First 72h of Life in the Two Study Groups.(NIPPV vs NCPAP) (first 3 days of life(72hours))
B: Composite of survival to 36 weeks gestational age, free of moderate-severe bronchopulmonary dysplasia (36 weeks gestational age)
C: Trigger Delay (last 5-min of each 15-min trial)
D: The rate of successful extubation with either mode of NCPAP (Day 7 post primary extubation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Corticosteroids, Glucose Control, and Depth-of-Anesthesia on Perioperative Inflammation and Morbidity From Major Non-cardiac Surgery (Dexamethasone, Light Anesthesia and Tight Glucose Control (DeLiT Trial))
Brief Summary: Evidence thus suggests that steroid administration, tight glucose control, and avoidance of deep anesthesia may decrease perioperative morbidity by reducing the inflammatory response to surgery. Using a three-way factorial approach, the investigators thus propose to test the primary hypotheses that major perioperative morbidity is reduced by: 1) low-dose dexamethasone; 2) intensive perioperative glucose control; and 3) lighter anesthesia.

Secondary hypotheses include that each intervention reduces circulating concentrations of the inflammatory marker CRP, and that there is a correlation between C-reactive protein (CRP) and post-operative complications. Anesthetic sensitivity predicts major and minor complications, and delirium Other secondary hypotheses are that each intervention, reduces minor surgical complications, reduces postoperative nausea and vomiting (PONV), reduces postoperative delirium, speeds hospital discharge, improves quality of life (SF-12v2 Health Survey, Christensen's VAS fatigue score), and reduces all-cause one-year mortality.


Options:
A: Evaluation of analgesic effect by 11-NRS scale (4th postoperative day)
B: Major Perioperative Morbidity (30 day after surgery)
C: pain during coughing (day 1)
D: Pain score by numeric rating scale (At 8 hours postoperatively)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Corticosteroids, Glucose Control, and Depth-of-Anesthesia on Perioperative Inflammation and Morbidity From Major Non-cardiac Surgery (Dexamethasone, Light Anesthesia and Tight Glucose Control (DeLiT Trial))
Brief Summary: Evidence thus suggests that steroid administration, tight glucose control, and avoidance of deep anesthesia may decrease perioperative morbidity by reducing the inflammatory response to surgery. Using a three-way factorial approach, the investigators thus propose to test the primary hypotheses that major perioperative morbidity is reduced by: 1) low-dose dexamethasone; 2) intensive perioperative glucose control; and 3) lighter anesthesia.

Secondary hypotheses include that each intervention reduces circulating concentrations of the inflammatory marker CRP, and that there is a correlation between C-reactive protein (CRP) and post-operative complications. Anesthetic sensitivity predicts major and minor complications, and delirium Other secondary hypotheses are that each intervention, reduces minor surgical complications, reduces postoperative nausea and vomiting (PONV), reduces postoperative delirium, speeds hospital discharge, improves quality of life (SF-12v2 Health Survey, Christensen's VAS fatigue score), and reduces all-cause one-year mortality.


Options:
A: Pain score by numeric rating scale (At 8 hours postoperatively)
B: Evaluation of analgesic effect by 11-NRS scale (4th postoperative day)
C: Nausea (0-72 hours postoperative)
D: Major Perioperative Morbidity (30 day after surgery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Protocol F1J-MC-HMFG Duloxetine 60 to 120 mg Versus Placebo in the Treatment of Patients With Osteoarthritis Knee Pain
Brief Summary: The primary purpose of this study is to determine if duloxetine reduces pain severity in patients with osteoarthritis knee pain.


Options:
A: McGill Pain Questionnaire - Short Form (Collected at 2 visits over 11 weeks: Visit 1 and Visit 3.); PamSys Actigraph Data (48 hours after visit 3); Pain Anxiety Symptoms Scale (PASS) (Collected at 2 visits over 11 weeks: Visit 1 and Visit 3.); Pain Disability Index (PDI) (Collected at 2 visits over 11 weeks: Visit 1 and Visit 3.); Center for Epidemiological Studies Depression Scale CESD-10 (CES-D 10) (Collected at 2 visits over 11 weeks: Visit 1 and Visit 3.); Pain Visual Analogue Scale (Collected at 2 visits over 11 weeks: Visit 1 and Visit 3.)
B: Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary (Over 13 Weeks)
C: Change From Baseline to 12 Weeks in Brief Pain Inventory 24-hour Average Pain Score (baseline, 12 weeks)
D: Change in Brief Pain Inventory (BPI) 24-hour Average Rating (Baseline, Week 4, Week 7, Week 13)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: COMPASS 3: An Open-label, Multi-Center Study Employing a Targeted 6-Minute Walk Test (6-MWT) Distance Threshold Approach to Guide Bosentan-Based Therapy and to Assess the Utility of Magnetic Resonance Imaging (MRI) on Cardiac Remodeling
Brief Summary: An open label, non-comparative study design is appropriate for this Phase 4 study designed to assess whether a core therapy of bosentan, either as monotherapy or with the addition of sildenafil, enables patients with pulmonary arterial hypertension (PAH) to achieve a 6-minute walk distance (6 MWD) of ≥380 meters after 28 weeks of therapy This design is also appropriate to pioneer the utility of cardiac MRI in assessing improved functional capacity in PAH and exploring its correlation with other parameters.


Options:
A: Number of Patients Reaching a 6-Minute Walk Test (6MWT) Distance ≥ 380 Meters (at 16 weeks and at 28 weeks of a stepped approach to therapy)
B: Endurance time (3 months)
C: Combined Outcome End-Point: all-cause mortality or hospital admission for heart failure, worsening of World Health Organization (WHO) functional class, or of the patient global assessment score (Six months)
D: Reduction of mean PAP and PVR (60 minutes)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The H10 EORTC/GELA/IIL Randomized Intergroup Trial on Early FDG-PET Scan Guided Treatment Adaptation Versus Standard Combined Modality Treatment in Patients With Supradiaphragmatic Stage I/II Hodgkin's Lymphoma
Brief Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Diagnostic procedures, such as fludeoxyglucose F 18 positron emission tomography (FDG-PET scan), may help doctors predict a patient's response to treatment and help plan the best treatment. It is not yet known whether FDG-PET scan-guided therapy is more effective than standard therapy in treating Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying FDG-PET scan-guided therapy to see how well it works compared with standard therapy in treating patients with previously untreated stage I or stage II Hodgkin's lymphoma.


Options:
A: progression-free survival (PFS) (3 year)
B: Progression-free survival
C: Progression Free Survival (5 years)
D: Progression free survival (5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The H10 EORTC/GELA/IIL Randomized Intergroup Trial on Early FDG-PET Scan Guided Treatment Adaptation Versus Standard Combined Modality Treatment in Patients With Supradiaphragmatic Stage I/II Hodgkin's Lymphoma
Brief Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Diagnostic procedures, such as fludeoxyglucose F 18 positron emission tomography (FDG-PET scan), may help doctors predict a patient's response to treatment and help plan the best treatment. It is not yet known whether FDG-PET scan-guided therapy is more effective than standard therapy in treating Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying FDG-PET scan-guided therapy to see how well it works compared with standard therapy in treating patients with previously untreated stage I or stage II Hodgkin's lymphoma.


Options:
A: Progression free survival (5 years)
B: 3-year progression-free survival (3 years)
C: Progression-free survival
D: Progression-free Survival by Independent Review (Up to approximately 4 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The H10 EORTC/GELA/IIL Randomized Intergroup Trial on Early FDG-PET Scan Guided Treatment Adaptation Versus Standard Combined Modality Treatment in Patients With Supradiaphragmatic Stage I/II Hodgkin's Lymphoma
Brief Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Diagnostic procedures, such as fludeoxyglucose F 18 positron emission tomography (FDG-PET scan), may help doctors predict a patient's response to treatment and help plan the best treatment. It is not yet known whether FDG-PET scan-guided therapy is more effective than standard therapy in treating Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying FDG-PET scan-guided therapy to see how well it works compared with standard therapy in treating patients with previously untreated stage I or stage II Hodgkin's lymphoma.


Options:
A: Failure-free Survival at 5 Years (Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5)
B: Progression-free survival
C: Overall survival; Reduction of late treatment-related toxicity; Maintenance of failure-free survival rate
D: Freedom from first progression at 5 years (After a median of 5 years from start of the study)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The H10 EORTC/GELA/IIL Randomized Intergroup Trial on Early FDG-PET Scan Guided Treatment Adaptation Versus Standard Combined Modality Treatment in Patients With Supradiaphragmatic Stage I/II Hodgkin's Lymphoma
Brief Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Diagnostic procedures, such as fludeoxyglucose F 18 positron emission tomography (FDG-PET scan), may help doctors predict a patient's response to treatment and help plan the best treatment. It is not yet known whether FDG-PET scan-guided therapy is more effective than standard therapy in treating Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying FDG-PET scan-guided therapy to see how well it works compared with standard therapy in treating patients with previously untreated stage I or stage II Hodgkin's lymphoma.


Options:
A: Event-free Survival (5 years)
B: Survival (12 years)
C: Progression free survival (PFS) (5 years)
D: Progression-free survival

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Epilepsy Phase III Trial
Brief Summary: The purpose of this study is to demonstrate that RWJ-333369 is safe and effective as add-on treatment of partial onset seizures.


Options:
A: N/A
B: The primary outcome is the change in seizure frequency of all simple partial motor, complex partial, or secondarily generalized seizures from the pretreatment baseline phase compared with the double-blind treatment phase.
C: The primary outcome is the change in seizure frequency of all simple partial motor, complex partial, or secondarily generalized seizures from the pretreatment baseline phase compared with the double-blind treatment phase.
D: Adverse events (Up to 1 year or until carisbamate is available by prescription or the study is terminated by the sponsor); Clinical laboratory test values (Up to 1 year or until carisbamate is available by prescription or the study is terminated by the sponsor); 12-lead ECG recordings (Up to 1 year or until carisbamate is available by prescription or the study is terminated by the sponsor); Vital sign measurements (Up to 1 year or until carisbamate is available by prescription or the study is terminated by the sponsor)

Answer: B