TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: PeRioperative OXygen Fraction - Effect on Surgical Site Infection and Pulmonary Complications After Abdominal Surgery (The PROXI-trial)
Brief Summary: Aim: To investigate the effect of high intra- and postoperative oxygen concentration (80%, as opposed to normally 30%) on surgical wound infection and pulmonary complications after abdominal surgery.

Background: Surgical wound infection is a common and serious complication. Tissue oxygen tension is often low after surgery and the resistance against infection depends on this factor through bacterial killing by neutrophils. Oxygen is a substrate in this reaction, and it is hypothesized that by increasing the arterial oxygen tension, the risk of surgical wound infection is reduced. Previous studies to test this hypothesis have shown entirely different results. Hence, the clinical decision between high and normal oxygen concentration is still controversial.

Primary hypothesis of study: Use of 80% oxygen decreases the incidence of surgical wound infection after abdominal surgery.

Secondary objectives: To investigate the effect 80% oxygen on pulmonary complications (atelectasis, pneumonia, respiratory insufficiency), second operation, mortality and length of postoperative hospitalization and admission to intensive care unit after abdominal surgery.


Options:
A: Daily Delta Sequential Organ Failure Assessment Score (14 days)
B: All-cause mortality or severe anoxic brain injury (3 months after OHCA.)
C: Surgical wound infection (14 days after surgery)
D: Ventilator-free Days (VFDs) to Study Day 28 (28 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: PeRioperative OXygen Fraction - Effect on Surgical Site Infection and Pulmonary Complications After Abdominal Surgery (The PROXI-trial)
Brief Summary: Aim: To investigate the effect of high intra- and postoperative oxygen concentration (80%, as opposed to normally 30%) on surgical wound infection and pulmonary complications after abdominal surgery.

Background: Surgical wound infection is a common and serious complication. Tissue oxygen tension is often low after surgery and the resistance against infection depends on this factor through bacterial killing by neutrophils. Oxygen is a substrate in this reaction, and it is hypothesized that by increasing the arterial oxygen tension, the risk of surgical wound infection is reduced. Previous studies to test this hypothesis have shown entirely different results. Hence, the clinical decision between high and normal oxygen concentration is still controversial.

Primary hypothesis of study: Use of 80% oxygen decreases the incidence of surgical wound infection after abdominal surgery.

Secondary objectives: To investigate the effect 80% oxygen on pulmonary complications (atelectasis, pneumonia, respiratory insufficiency), second operation, mortality and length of postoperative hospitalization and admission to intensive care unit after abdominal surgery.


Options:
A: Chest pain measured with VAS (1 h)
B: Myocardial Infarct Size (At 72 hours post infarct)
C: Surgical wound infection (14 days after surgery)
D: Neuron-specific enolase (NSE) serum concentration (48 hour after cardiac arrest)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: PeRioperative OXygen Fraction - Effect on Surgical Site Infection and Pulmonary Complications After Abdominal Surgery (The PROXI-trial)
Brief Summary: Aim: To investigate the effect of high intra- and postoperative oxygen concentration (80%, as opposed to normally 30%) on surgical wound infection and pulmonary complications after abdominal surgery.

Background: Surgical wound infection is a common and serious complication. Tissue oxygen tension is often low after surgery and the resistance against infection depends on this factor through bacterial killing by neutrophils. Oxygen is a substrate in this reaction, and it is hypothesized that by increasing the arterial oxygen tension, the risk of surgical wound infection is reduced. Previous studies to test this hypothesis have shown entirely different results. Hence, the clinical decision between high and normal oxygen concentration is still controversial.

Primary hypothesis of study: Use of 80% oxygen decreases the incidence of surgical wound infection after abdominal surgery.

Secondary objectives: To investigate the effect 80% oxygen on pulmonary complications (atelectasis, pneumonia, respiratory insufficiency), second operation, mortality and length of postoperative hospitalization and admission to intensive care unit after abdominal surgery.


Options:
A: Myocardial Infarct Size (At 72 hours post infarct)
B: Surgical wound infection (14 days after surgery)
C: Surgical wound infection (30 days)
D: The primary endpoint is hospital length of stay (LOS), defined from the start of surgery until actual hospital discharge. Patients transferred to another hospital will be tracked until final discharge to home (or other final destination). LOS is likely

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label, Multicenter, Randomized Study to Determine Dose Conversion Factors at Different Frequencies of Administration After Switching From Maintenance Treatment With Subcutaneous Epoetin Alfa or Beta to Maintenance Treatment With Subcutaneous RO0503821 in Dialysis Patients With Chronic Renal Anemia
Brief Summary: This study will determine the appropriate dose and frequency of administration of sc Mircera maintenance therapy in dialysis patients with chronic renal anemia who were previously receiving sc epoetin alfa or beta. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.


Options:
A: Percentage of Participants With Lesser Than or Equal to One Gram Per Deciliter Decrease in Average Hemoglobin From Baseline and Maintaining Average Hemoglobin Level Greater Than or Equal to 10.5 g/dL Over Evaluation Period (Baseline (Week -4 to Week -1) and Evaluation period (Weeks 50 to 53))
B: Mean Change in Hemoglobin Concentration (g/dL) From Baseline to Evaluation Period (Baseline (Week -4 to Week -1) and Evaluation Period (Week 29 to Week 36))
C: Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen (From Baseline (Day -28 to Day 1) to EOIT (Week 19 or Week 21))
D: changes in gene-arrays, EPC and biomarkers panels (14 days, 6 and 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label, Multicenter, Randomized Study to Determine Dose Conversion Factors at Different Frequencies of Administration After Switching From Maintenance Treatment With Subcutaneous Epoetin Alfa or Beta to Maintenance Treatment With Subcutaneous RO0503821 in Dialysis Patients With Chronic Renal Anemia
Brief Summary: This study will determine the appropriate dose and frequency of administration of sc Mircera maintenance therapy in dialysis patients with chronic renal anemia who were previously receiving sc epoetin alfa or beta. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.


Options:
A: The primary outcome will be a composite consisting of mortality (all cause), myocardial infarction, stroke, and CHF hospitalization (not including those hospitalizations during which RRT occurs)
B: Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen (From Baseline (Day -28 to Day 1) to EOIT (Week 19 or Week 21))
C: Median Time to First Cardiovascular Event (Up to 4 years)
D: Cost of Erythropoiesis Stimulating Agent (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label, Multicenter, Randomized Study to Determine Dose Conversion Factors at Different Frequencies of Administration After Switching From Maintenance Treatment With Subcutaneous Epoetin Alfa or Beta to Maintenance Treatment With Subcutaneous RO0503821 in Dialysis Patients With Chronic Renal Anemia
Brief Summary: This study will determine the appropriate dose and frequency of administration of sc Mircera maintenance therapy in dialysis patients with chronic renal anemia who were previously receiving sc epoetin alfa or beta. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.


Options:
A: Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen (From Baseline (Day -28 to Day 1) to EOIT (Week 19 or Week 21))
B: Percentage of Participants With Lesser Than or Equal to One Gram Per Deciliter Decrease in Average Hemoglobin From Baseline and Maintaining Average Hemoglobin Level Greater Than or Equal to 10.5 g/dL Over Evaluation Period (Baseline (Week -4 to Week -1) and Evaluation period (Weeks 50 to 53))
C: Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb and Within Target Range During the Efficacy Evaluation Period (EEP) (Weeks -4, -3, -2, and -1; pre-dose (0 hours) during Weeks 18, 20, 22, and 24)
D: Percentage of Participants Maintaining Average Hemoglobin Concentration Within +/-1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range (Week 17 up to Week 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label, Multicenter, Randomized Study to Determine Dose Conversion Factors at Different Frequencies of Administration After Switching From Maintenance Treatment With Subcutaneous Epoetin Alfa or Beta to Maintenance Treatment With Subcutaneous RO0503821 in Dialysis Patients With Chronic Renal Anemia
Brief Summary: This study will determine the appropriate dose and frequency of administration of sc Mircera maintenance therapy in dialysis patients with chronic renal anemia who were previously receiving sc epoetin alfa or beta. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.


Options:
A: Mean Change in Hemoglobin Between Baseline and the Evaluation Period (Baseline and Weeks 29-36)
B: Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen (From Baseline (Day -28 to Day 1) to EOIT (Week 19 or Week 21))
C: Mean Change in Hemoglobin Between Baseline and the Evaluation Period (Baseline and Weeks 25-36)
D: Percentage of Participants With Lesser Than or Equal to One Gram Per Deciliter Decrease in Average Hemoglobin From Baseline and Maintaining Average Hemoglobin Level Greater Than or Equal to 10.5 g/dL Over Evaluation Period (Baseline (Week -4 to Week -1) and Evaluation period (Weeks 50 to 53))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Post-Traumatic Stress Disorder (PTSD) Treatment in Cardiac Patients
Brief Summary: This study will evaluate the safety and efficacy of cognitive behavioral therapy in treating people who are experiencing post-traumatic stress disorder after a heart attack.


Options:
A: Admission to hospital for recurrent CHD event (8 years)
B: Average blood pressure (Measured at Months 2 and 6); Impact of Event Scales (IES) (Measured at Months 2 and 6)
C: Depressive Symptom Reduction (Change from depression at baseline to depression at 6-months); Cost for Healthcare Utilization (Psychiatric Medications, Hospitalizations, Cardiac Procedures, Outpatient Services) (6 months after randomization)
D: Clinician-rated posttraumatic stress level (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Otitis and Literacy and Attention at 9 to 11 Years
Brief Summary: Middle-ear disease (infection and fluid) is the most common illness in young children after the common cold. Because hearing loss accompanies middle-ear disease, and because early life is a period of rapid development, concern has existed that sustained periods of middle-ear disease might cause lasting impairments of learning, speech development, language development, or behavior and social adjustment. Earlier phases of this research found that the insertion of ear tubes in children younger than 3 years of age with persistent middle-ear disease did not affect their development at 3, 4, or 6 years of age. This study examines the children's literacy, attention, and related abilities at 9 to 11 years of age.


Options:
A: All measures at 9 to 11 years of age:; Woodcock Reading Mastery Tests-Revised-Normative Update; Number of words in a grade-level passage read correctly in one minute; Dictation Samples subtest of the Woodcock-Johnson III Tests of Achievement, Standard Battery; Writing Samples subtests of the Woodcock-Johnson III Tests of Achievement, Standard Battery; Elision and Rapid Letter Naming subtests of the Comprehensive Test of Phonological Processing; Children's version of the Hearing in Noise Test; Disruptive Behavior Disorders Rating Scale; Child Behavior Checklist, parent report; Child Behavior Checklist, teacher report; Impairment Rating Scales, parent report; Impairment Rating Scales, teacher report; Computerized visual continuous performance test; Computerized auditory continuous performance test; Wechsler Abbreviated Scale of Intelligence; Computational subtest of the Woodcock-Johnson III Tests of Achievement, Standard Battery
B: Number of visits to health clinic (Two years after randomisation)
C: - number of acute otitis media; - quality of life issues
D: Number of Subjects With Complete Normalization of Abnormal Tympanometry, Regardless of Additional Treatment (6 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Otitis and Literacy and Attention at 9 to 11 Years
Brief Summary: Middle-ear disease (infection and fluid) is the most common illness in young children after the common cold. Because hearing loss accompanies middle-ear disease, and because early life is a period of rapid development, concern has existed that sustained periods of middle-ear disease might cause lasting impairments of learning, speech development, language development, or behavior and social adjustment. Earlier phases of this research found that the insertion of ear tubes in children younger than 3 years of age with persistent middle-ear disease did not affect their development at 3, 4, or 6 years of age. This study examines the children's literacy, attention, and related abilities at 9 to 11 years of age.


Options:
A: All measures at 9 to 11 years of age:; Woodcock Reading Mastery Tests-Revised-Normative Update; Number of words in a grade-level passage read correctly in one minute; Dictation Samples subtest of the Woodcock-Johnson III Tests of Achievement, Standard Battery; Writing Samples subtests of the Woodcock-Johnson III Tests of Achievement, Standard Battery; Elision and Rapid Letter Naming subtests of the Comprehensive Test of Phonological Processing; Children's version of the Hearing in Noise Test; Disruptive Behavior Disorders Rating Scale; Child Behavior Checklist, parent report; Child Behavior Checklist, teacher report; Impairment Rating Scales, parent report; Impairment Rating Scales, teacher report; Computerized visual continuous performance test; Computerized auditory continuous performance test; Wechsler Abbreviated Scale of Intelligence; Computational subtest of the Woodcock-Johnson III Tests of Achievement, Standard Battery
B: Non B type tympanogram (one month)
C: Proportion of children with middle ear effusion (end of intervention); Proportion of study visits at which middle ear effusion detected (during intervention)
D: Number of visits to health clinic (Two years after randomisation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Otitis and Literacy and Attention at 9 to 11 Years
Brief Summary: Middle-ear disease (infection and fluid) is the most common illness in young children after the common cold. Because hearing loss accompanies middle-ear disease, and because early life is a period of rapid development, concern has existed that sustained periods of middle-ear disease might cause lasting impairments of learning, speech development, language development, or behavior and social adjustment. Earlier phases of this research found that the insertion of ear tubes in children younger than 3 years of age with persistent middle-ear disease did not affect their development at 3, 4, or 6 years of age. This study examines the children's literacy, attention, and related abilities at 9 to 11 years of age.


Options:
A: Non B type tympanogram (one month)
B: All measures at 9 to 11 years of age:; Woodcock Reading Mastery Tests-Revised-Normative Update; Number of words in a grade-level passage read correctly in one minute; Dictation Samples subtest of the Woodcock-Johnson III Tests of Achievement, Standard Battery; Writing Samples subtests of the Woodcock-Johnson III Tests of Achievement, Standard Battery; Elision and Rapid Letter Naming subtests of the Comprehensive Test of Phonological Processing; Children's version of the Hearing in Noise Test; Disruptive Behavior Disorders Rating Scale; Child Behavior Checklist, parent report; Child Behavior Checklist, teacher report; Impairment Rating Scales, parent report; Impairment Rating Scales, teacher report; Computerized visual continuous performance test; Computerized auditory continuous performance test; Wechsler Abbreviated Scale of Intelligence; Computational subtest of the Woodcock-Johnson III Tests of Achievement, Standard Battery
C: Proportion of children with middle ear effusion (end of intervention); Proportion of study visits at which middle ear effusion detected (during intervention)
D: Treatment response (1 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Otitis and Literacy and Attention at 9 to 11 Years
Brief Summary: Middle-ear disease (infection and fluid) is the most common illness in young children after the common cold. Because hearing loss accompanies middle-ear disease, and because early life is a period of rapid development, concern has existed that sustained periods of middle-ear disease might cause lasting impairments of learning, speech development, language development, or behavior and social adjustment. Earlier phases of this research found that the insertion of ear tubes in children younger than 3 years of age with persistent middle-ear disease did not affect their development at 3, 4, or 6 years of age. This study examines the children's literacy, attention, and related abilities at 9 to 11 years of age.


Options:
A: Number of Subjects With Complete Normalization of Abnormal Tympanometry, Regardless of Additional Treatment (6 weeks)
B: Proportion of children with middle ear effusion (end of intervention); Proportion of study visits at which middle ear effusion detected (during intervention)
C: All measures at 9 to 11 years of age:; Woodcock Reading Mastery Tests-Revised-Normative Update; Number of words in a grade-level passage read correctly in one minute; Dictation Samples subtest of the Woodcock-Johnson III Tests of Achievement, Standard Battery; Writing Samples subtests of the Woodcock-Johnson III Tests of Achievement, Standard Battery; Elision and Rapid Letter Naming subtests of the Comprehensive Test of Phonological Processing; Children's version of the Hearing in Noise Test; Disruptive Behavior Disorders Rating Scale; Child Behavior Checklist, parent report; Child Behavior Checklist, teacher report; Impairment Rating Scales, parent report; Impairment Rating Scales, teacher report; Computerized visual continuous performance test; Computerized auditory continuous performance test; Wechsler Abbreviated Scale of Intelligence; Computational subtest of the Woodcock-Johnson III Tests of Achievement, Standard Battery
D: Number of visits to health clinic (Two years after randomisation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Otitis and Literacy and Attention at 9 to 11 Years
Brief Summary: Middle-ear disease (infection and fluid) is the most common illness in young children after the common cold. Because hearing loss accompanies middle-ear disease, and because early life is a period of rapid development, concern has existed that sustained periods of middle-ear disease might cause lasting impairments of learning, speech development, language development, or behavior and social adjustment. Earlier phases of this research found that the insertion of ear tubes in children younger than 3 years of age with persistent middle-ear disease did not affect their development at 3, 4, or 6 years of age. This study examines the children's literacy, attention, and related abilities at 9 to 11 years of age.


Options:
A: Proportion of children with middle ear effusion (end of intervention); Proportion of study visits at which middle ear effusion detected (during intervention)
B: All measures at 9 to 11 years of age:; Woodcock Reading Mastery Tests-Revised-Normative Update; Number of words in a grade-level passage read correctly in one minute; Dictation Samples subtest of the Woodcock-Johnson III Tests of Achievement, Standard Battery; Writing Samples subtests of the Woodcock-Johnson III Tests of Achievement, Standard Battery; Elision and Rapid Letter Naming subtests of the Comprehensive Test of Phonological Processing; Children's version of the Hearing in Noise Test; Disruptive Behavior Disorders Rating Scale; Child Behavior Checklist, parent report; Child Behavior Checklist, teacher report; Impairment Rating Scales, parent report; Impairment Rating Scales, teacher report; Computerized visual continuous performance test; Computerized auditory continuous performance test; Wechsler Abbreviated Scale of Intelligence; Computational subtest of the Woodcock-Johnson III Tests of Achievement, Standard Battery
C: Treatment response (1 months)
D: - number of acute otitis media; - quality of life issues

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Parallel-group, Open-label, Multinational Trial Comparing the Safety and Efficacy of Insulin Aspart (NovoRapid®) Versus Human Insulin (Actrapid®), Used in a Multiple Injection Regimen, in the Treatment of Pregnant Women With Type 1 Diabetes, Focusing on Maternal Hypoglycaemia and Pregnancy Outcomes
Brief Summary: This trial was conducted in Europe, Middle East, North America and South America.

The aim of this trial was to compare the use of an intensified insulin treatment with insulin aspart (NovoRapid®) versus human insulin (Actrapid®) in pregnancy.


Options:
A: Number of Participants With a 2-step or Greater Increase in Early Treatment Diabetic Retinopathy Study (ETDRS) Severity Scale. (From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.)
B: Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale (From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.)
C: Relative risk of major maternal hypoglycaemia (after 24 hours)
D: Glycosylated Haemoglobin (HbA1c) for Full Analysis Set (Pregnant Subjects) at GW 36 (At gestational week (GW) 36); Glycosylated Haemoglobin (HbA1c) for Per Protocol Analysis Set (Pregnant Subjects) at GW 36 (At gestational week (GW) 36)

Answer: C