TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IV, Randomized, Single Center, Parallel Group Trial of Human Fibrinogen Concentrate (Haemocomplettan) in the Treatment of Dilutional Coagulopathy During Major Pediatric Surgery
Brief Summary: The purpose of this study is to compare two different thromboelastometry (ROTEM) trigger levels for administration of human fibrinogen concentrate (Haemocomplettan P) in the treatment of perioperative dilutional coagulopathy during major pediatric surgery. The study hypothesis is that administration of fibrinogen concentrate triggered by a ROTEM FibTEM MCF \< 13 mm might reduce the total amount of transfused red cell concentrate during 24 hours after start of surgery as compared to a trigger level of ROTEM FibTEM MCF \< 8 mm.


Options:
A: Change from baseline ROTEM® measurements after the administration of heparin
B: amount of transfused red blood cell concentrates (24 h after begin of surgical intervention)
C: Graft patency at 3 months (3 months)
D: Total amount of transfused red cell concentrate (24 hours after start of surgery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Study of the Use of Human Milk Cream as a Caloric Supplement in a Subset of Very Low Birth Weight Pre-Term Infants
Brief Summary: Human milk is commonly considered to have 20 calories per ounce (kcal/oz). However, studies show that up to 65% of human milk may be less than the expected 20 kcal/oz which can greatly affect an infant's growth. The investigators now have the ability to measure caloric density of human milk and add human milk cream to any human milk (mother's own or donor human milk) that is less than 20 kcal/oz to bring it up to that amount.


Options:
A: Daily growth velocity (g/kg/day) (From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks))
B: Weight gain (From birth - to the end of study intervention (anticipated to be on average 1 week before discharge home at approx 37 weeks PMA))
C: Weight gain (g/d) between full strength fortification with full volume intake (day 1) through 21 days of study after that day. (21 days)
D: Caloric content of human milk (Daily until 36 weeks corrected gestational age)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Study of the Use of Human Milk Cream as a Caloric Supplement in a Subset of Very Low Birth Weight Pre-Term Infants
Brief Summary: Human milk is commonly considered to have 20 calories per ounce (kcal/oz). However, studies show that up to 65% of human milk may be less than the expected 20 kcal/oz which can greatly affect an infant's growth. The investigators now have the ability to measure caloric density of human milk and add human milk cream to any human milk (mother's own or donor human milk) that is less than 20 kcal/oz to bring it up to that amount.


Options:
A: growth (from inclusion at postmentrual age <32 weeks until 36 weeks)
B: Weight gain (From birth - to the end of study intervention (anticipated to be on average 1 week before discharge home at approx 37 weeks PMA))
C: Daily growth velocity (g/kg/day) (From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks))
D: Caloric content of human milk (Daily until 36 weeks corrected gestational age)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Study of the Use of Human Milk Cream as a Caloric Supplement in a Subset of Very Low Birth Weight Pre-Term Infants
Brief Summary: Human milk is commonly considered to have 20 calories per ounce (kcal/oz). However, studies show that up to 65% of human milk may be less than the expected 20 kcal/oz which can greatly affect an infant's growth. The investigators now have the ability to measure caloric density of human milk and add human milk cream to any human milk (mother's own or donor human milk) that is less than 20 kcal/oz to bring it up to that amount.


Options:
A: growth (from inclusion at postmentrual age <32 weeks until 36 weeks)
B: Caloric content of human milk (Daily until 36 weeks corrected gestational age)
C: Weight gain due to fat mass (4 weeks)
D: Weight gain (29 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Efficacy, Safety and Pharmacokinetic Study on the Short-term and Long-term Use of Metformin in Obese Children and Adolescents
Brief Summary: The purpose of this study is to determine whether metformin is effective in reducing BMI and insulin resistance in obese children and adolescents.


Options:
A: Change in BMI from baseline (18 months and 36 months); Change in Insulin resistance from baseline (3; 6; 9; 12; 15; 18; 24; 30 and 36 months)
B: Change in Hemoglobin A1c From Baseline to 26 Weeks, Adjusted for Baseline Hemoglobin A1c. (0-26 weeks)
C: Percent Change From Baseline in Body Mass Index at 3-months (Baseline and 3-months)
D: Risk of Experiencing a Primary Outcome Event (POE) (i.e., Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, Resuscitated Cardiac Arrest, Cardiovascular [CV] Death) (From randomization up to 6 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Parallel-group, Active-controlled, Flexible Dose Study Evaluating the Effects of [Vortioxetine] Lu AA21004 Versus Agomelatine in Adult Patients Suffering From Major Depressive Disorder With Inadequate Response to Antidepressant Treatment
Brief Summary: The objective of the present study is to evaluate whether vortioxetine (10 or 20 mg/day) is at least as effective as agomelatine (25 to 50 mg/day) in patients with depressive symptoms that showed inadequate response to Serotonin Reuptake Inhibitors (SRI) antidepressants.


Options:
A: Change From Baseline in MADRS Total Score After 6 Weeks of Treatment (Baseline and Week 6)
B: Change From Baseline in MADRS Total Score at Week 8 (Baseline and Week 8)
C: Change From Baseline in MADRS Total Score at Week 8 (Baseline and Week 8)
D: Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score (Baseline and Week 8)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Parallel-group, Active-controlled, Flexible Dose Study Evaluating the Effects of [Vortioxetine] Lu AA21004 Versus Agomelatine in Adult Patients Suffering From Major Depressive Disorder With Inadequate Response to Antidepressant Treatment
Brief Summary: The objective of the present study is to evaluate whether vortioxetine (10 or 20 mg/day) is at least as effective as agomelatine (25 to 50 mg/day) in patients with depressive symptoms that showed inadequate response to Serotonin Reuptake Inhibitors (SRI) antidepressants.


Options:
A: Change From Baseline in MADRS Total Score at Week 8 (Baseline and Week 8)
B: The Primary Outcome Measure Will be Response Rates (50% Decrease in HAM-D-17 Scores) During Phase 2 (8 Weeks)
C: Change in the Montgomery-Asberg Depression (From baseline (end of Phase A [Week 8]) to week 14)
D: Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 8 (Baseline to Week 8)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Trial of Cetuximab and Dasatinib in Patients With Cetuximab-resistant, Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck and Low Serum IL-6
Brief Summary: This is a single-arm, non-masked, open-label, Phase II study of cetuximab + dasatinib in recurrent Squamous Cell Carcinoma of The Head and Neck (SCCHN) that has recurred after cetuximab-containing therapy (please see attached schema).

The primary endpoint 12-week PFS.


Options:
A: The primary endpoints are comprised of a panel of tumor proteins to be obtained before after administration of the study drugs. (2-3 week preoperative period of drug administration)
B: Progression-free Survival (PFS) According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Independent Radiology Plus Oncology Review (IRO) (Up to approximately 12 months (through first pre-specified statistical analysis cut-off date of 03-Sep-2014)); Percentage of Participants With Overall Survival (OS) at 12 Months (Month 12)
C: Overall Response Rate (ORR) (Up to 36 months); Response to Treatment (Up to 36 months)
D: Disease free survival (3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose is to determine if the consumption of study product has an effect on acute respiratory infections and/or diarrheal disease.


Options:
A: N/A
B: Evaluate the efficacy of fermented milk and rice administered daily for a total duration of 3 months on the appearance of common respiratory and gastrointestinal infections in schoolchildren aged between 12 and 48 months. (3 months)
C: Body composition (4 months)
D: Acute respiratory infections and diarrheal disease (28 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose is to determine if the consumption of study product has an effect on acute respiratory infections and/or diarrheal disease.


Options:
A: Common infections
B: Acute respiratory infections and diarrheal disease (28 weeks)
C: Number of participants with allergic disease (Up to 13 years); Weight gain (Up to 13 years); Number of patients with chronic inflammatory disease (Up to 13 years)
D: The mean number of episodes and duration of acute diarrheal disease (24 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Controlled, Randomized Clinical Trial of Nebulized Hypertonic Saline for Hospitalized Infants With Viral Bronchiolitis
Brief Summary: The purpose of this study is to determine if nebulized hypertonic saline (or extra salty water mist) helps infants less than 12 months old hospitalized with bronchiolitis (or bad chest colds) get better enough to be discharged from the hospital sooner than those infants given nebulized normal saline (or regular salty water mist).


Options:
A: Length of Stay in the Study-LOS--Intention to Treat Analysis (Time of first study treatment until time of discharge); Length of Stay in the Study-LOS by Per Protocol Analysis (Time of first study treatment until time of discharge)
B: Respiratory Assessment Change Score (RACS) (Baseline and 1 hour)
C: Mean pre-nebulization bronchiolitis severity score for each treatment group at 48 hours (2 years)
D: Time to 'fit for discharge' (This was judged to be when the infant was feeding adequately [taking >75% of usual intake] and was in air with a saturation of at least 92% for 6 hours, to reflect clinical practice.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Controlled, Randomized Clinical Trial of Nebulized Hypertonic Saline for Hospitalized Infants With Viral Bronchiolitis
Brief Summary: The purpose of this study is to determine if nebulized hypertonic saline (or extra salty water mist) helps infants less than 12 months old hospitalized with bronchiolitis (or bad chest colds) get better enough to be discharged from the hospital sooner than those infants given nebulized normal saline (or regular salty water mist).


Options:
A: Length of Stay in the Study-LOS--Intention to Treat Analysis (Time of first study treatment until time of discharge); Length of Stay in the Study-LOS by Per Protocol Analysis (Time of first study treatment until time of discharge)
B: Mean Change in Clinical Severity Score (2 hours)
C: Change in Bronchiolitis Severity Score (Baseline and up to 24 hours of hospital stay)
D: Mean pre-nebulization bronchiolitis severity score for each treatment group at 48 hours (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of the Level of Dietary Protein on Infant Growth and Body Composition in the First Year of Life - Three and Five Year Growth and Body Composition Follow-up
Brief Summary: The purpose of this study is to determine if toddlers and children who were fed breast milk or infant formulas at different levels of protein between 3 and 12 months of age have differences in growth and body composition at 3 and 5 years of age.


Options:
A: Comparison of the compositions of the intestinal microbiota of infants fed formula and breast milk by high-throughput sequencing (up to 8 months)
B: Mean weight gain (3 years); Mean weight gain (5 years)
C: Body mass index BMI: derived from measured body height (m) and body weight (kg) as body weight / height² (At age 11 years and 18 years)
D: Infant weight gain (Between ages 14 weeks (+/- 1 week) and 12 months (+/- 2 weeks))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prompt Panretinal Photocoagulation Versus Intravitreal Ranibizumab With Deferred Panretinal Photocoagulation for Proliferative Diabetic Retinopathy
Brief Summary: The primary objective of the protocol is to determine if visual acuity outcomes at 2 years in eyes with proliferative diabetic retinopathy (PDR) that receive anti-vascular endothelial growth factor (anti-VEGF) therapy with deferred panretinal photocoagulation (PRP) are non-inferior to those in eyes that receive standard prompt PRP therapy.

Secondary objectives include:

* Comparing other visual function outcomes (including Humphrey visual field testing and study participant self-reports of visual function) in eyes receiving anti-VEGF with deferred PRP with those in eyes receiving prompt PRP.
* Determining percent of eyes not requiring PRP when anti-VEGF is given in the absence of prompt PRP.
* Comparing safety outcomes between treatment groups.
* Comparing associated treatment and follow-up exam costs between treatment groups.


Options:
A: Number of Participants With Progression of Diabetic Retinopathy of at Least 3 Stages on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale, or Development of Proliferative Diabetic Retinopathy Necessitating Photocoagulation Therapy or Vitrectomy (Measured at Year 4)
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: Development of PDR and/or DME (Whichever Came First) (2 years); Change in Visual Acuity From Baseline (2 years)
D: Mean Change in Visual Acuity From Baseline (2-years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prompt Panretinal Photocoagulation Versus Intravitreal Ranibizumab With Deferred Panretinal Photocoagulation for Proliferative Diabetic Retinopathy
Brief Summary: The primary objective of the protocol is to determine if visual acuity outcomes at 2 years in eyes with proliferative diabetic retinopathy (PDR) that receive anti-vascular endothelial growth factor (anti-VEGF) therapy with deferred panretinal photocoagulation (PRP) are non-inferior to those in eyes that receive standard prompt PRP therapy.

Secondary objectives include:

* Comparing other visual function outcomes (including Humphrey visual field testing and study participant self-reports of visual function) in eyes receiving anti-VEGF with deferred PRP with those in eyes receiving prompt PRP.
* Determining percent of eyes not requiring PRP when anti-VEGF is given in the absence of prompt PRP.
* Comparing safety outcomes between treatment groups.
* Comparing associated treatment and follow-up exam costs between treatment groups.


Options:
A: Functional Macular Evaluation (24 weeks)
B: Mean Change in Visual Acuity From Baseline (2-years)
C: fluorescein angiography leakage area (from baseline to week 48.)
D: Mean Change From Baseline in BCVA Letter Score at Week 24, in Treatment-Naive Participants (Baseline, Week 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prompt Panretinal Photocoagulation Versus Intravitreal Ranibizumab With Deferred Panretinal Photocoagulation for Proliferative Diabetic Retinopathy
Brief Summary: The primary objective of the protocol is to determine if visual acuity outcomes at 2 years in eyes with proliferative diabetic retinopathy (PDR) that receive anti-vascular endothelial growth factor (anti-VEGF) therapy with deferred panretinal photocoagulation (PRP) are non-inferior to those in eyes that receive standard prompt PRP therapy.

Secondary objectives include:

* Comparing other visual function outcomes (including Humphrey visual field testing and study participant self-reports of visual function) in eyes receiving anti-VEGF with deferred PRP with those in eyes receiving prompt PRP.
* Determining percent of eyes not requiring PRP when anti-VEGF is given in the absence of prompt PRP.
* Comparing safety outcomes between treatment groups.
* Comparing associated treatment and follow-up exam costs between treatment groups.


Options:
A: Primary Major Macrovascular Events (Post baseline time to the first major macrovascular event up to 82 months)
B: Mean Change in Visual Acuity From Baseline (2-years)
C: 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)
D: Number of Participants With Progression of Diabetic Retinopathy of at Least 3 Stages on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale, or Development of Proliferative Diabetic Retinopathy Necessitating Photocoagulation Therapy or Vitrectomy (Measured at Year 4)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-centre, Randomized, Double-blind, Placebo-controlled, Parallel-group, 9 Month, Equivalence Trial Comparing the Efficacy and Safety and Tolerability of GTR (Synthon BV) to Copaxone® (Teva) in Subjects With Relapsing Remitting Multiple Sclerosis Followed by an Open-label 15 Month GTR Treatment Part Evaluating the Long-term GTR Treatment Effects
Brief Summary: The purpose of this study is demonstrate that efficacy and safety of Synthon's glatiramer acetate (GTR) is equivalent to Copaxone® (Teva) in patients with relapsing remitting multiple sclerosis


Options:
A: Estimated Annualized Aggregate Relapse Rate (ARR) in the Core Phase of the Study (Baseline to Month 12)
B: Core Treatment Period: Overview of Failures (Core treatment period between 48 and 118 weeks depending on when the participant was enrolled); Core Treatment Period: Time to Failure: Kaplan-Meier Estimates of the Rate of Failure at Timepoints (Core treatment period between 48 and 118 weeks depending on when the participant was enrolled)
C: The Number of T1-Gadolinium Enhancing Lesions During Months 7-9 (9 months)
D: Percentage of Participants With Sustained Accumulation of Disability (SAD) (Up to 2 years); Annualized Relapse Rate (Up to 2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-centre, Randomized, Double-blind, Placebo-controlled, Parallel-group, 9 Month, Equivalence Trial Comparing the Efficacy and Safety and Tolerability of GTR (Synthon BV) to Copaxone® (Teva) in Subjects With Relapsing Remitting Multiple Sclerosis Followed by an Open-label 15 Month GTR Treatment Part Evaluating the Long-term GTR Treatment Effects
Brief Summary: The purpose of this study is demonstrate that efficacy and safety of Synthon's glatiramer acetate (GTR) is equivalent to Copaxone® (Teva) in patients with relapsing remitting multiple sclerosis


Options:
A: Adjusted Annualized Relapse Rate Between Baseline and Week 52 (Baseline through Week 52)
B: Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From first dose to two weeks after last dose of study drug (Up to 98 weeks)); Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities (From first dose to two weeks after last dose of study drug (Up to 98 weeks)); Number of Participants With Potentially Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities (From first dose to two weeks after last dose of study drug (Up to 98 weeks)); Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Score at Any Post-Baseline Visit (Up to 98 weeks); Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (From first dose to two weeks after last dose of study drug (Up to 98 weeks))
C: The Number of T1-Gadolinium Enhancing Lesions During Months 7-9 (9 months)
D: Annualized Relapse Rate (ARR) at 1 Year (1 Year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Interest of a Steroid Pre-treatment Prior to IVF Protocol With Ovarian Stimulation by Recombinant FSH and With LH Surge Blockage by Daily GnRH Antagonist
Brief Summary: The purpose of this study is to assess whether estrogen pre-treatment can allow retrieval of 2 additional oocytes in GnRH antagonist protocol.


Options:
A: number of retrieved oocytes (at the ovarian puncture, 36 hours post HCG administration)
B: Total Number of Oocytes (12 weeks)
C: Percentage of Participants With an Ongoing Pregnancy (Ongoing Pregnancy Rate) (Assessed at least 10 weeks after embryo transfer (up to 1 year)); Mean Number of Oocytes Retrieved (Up to 36 hours after administration of hCG (up to 1 year))
D: clinical pregnancy rate confirmed by ultrasound evidence of fetal heart activity (12 weeks after embryo transfer)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Blinded, Double-dummy, Placebo-controlled, 3-period Cross-over Study to Evaluate the Effect of QVA149 on Patient Reported Dyspnea in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Tiotropium as an Active Control
Brief Summary: This study assessed the effect of QVA149 on patient-reported dyspnea in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) patients.


Options:
A: Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Placebo (Baseline and 6 weeks)
B: Change From Baseline Trough in 24-Hour Weighted Mean FEV1 on Treatment Day 84 (Baseline (Day 1) and Day 84)
C: The primary efficacy variable was forced expiratory volume in one second (FEV1). There were two co-primary endpoints: FEV1 area under the curve for the time period 0 to 12 hours [FEV1 AUC (0-12)] and peak FEV1 measured after 6 weeks of treatment.
D: Change From Baseline in Morning -Pre-dose Trough FEV1 Over 52 Weeks (Baseline and Weeks 2 to 52)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Blinded, Double-dummy, Placebo-controlled, 3-period Cross-over Study to Evaluate the Effect of QVA149 on Patient Reported Dyspnea in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Tiotropium as an Active Control
Brief Summary: This study assessed the effect of QVA149 on patient-reported dyspnea in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) patients.


Options:
A: Trough Forced Expiratory Volume at 1 Second (FEV1) (12 weeks)
B: Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 (Baseline and at Week 24)
C: Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Placebo (Baseline and 6 weeks)
D: Number of Participants With Any On-treatment Adverse Event (AE) or Any Serious Adverse Event (SAE) (From the start of study drug up to 52 weeks)

Answer: C