TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: A Randomised, Double-blind, Placebo Controlled, Parallel Group, Multi-centre, Multinational Trial With Stratification of Subject to Either 56 or 160 Weeks of Treatment Based on Pre-diabetes Status at Randomisation
Brief Summary: This trial is conducted in Africa, Asia, Europe, Oceania, North America and South America.

The aim of this clinical trial is to evaluate the potential of liraglutide to induce and maintain weight loss over 56 weeks in obese subjects or overweight subjects with co-morbidities. Furthermore, the aim is to investigate the long term potential of liraglutide to delay the onset of type 2 diabetes in subjects diagnosed with pre-diabetes at baseline.

Based on body mass index (BMI) and pre-diabetes status, subjects will be randomised to either 68 weeks (56 weeks of randomised treatment followed by a 12 week re-randomised treatment period) or 160 weeks of treatment (160 week treatment will only be applicable to subjects with pre-diabetes status at baseline).


Options:
A: Change From Baseline in Fasting Body Weight (Week 0, Week 56); Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight. (At Week 56); Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight (At 56 weeks); Proportion of Subjects With Onset of Type 2 Diabetes (At 160 weeks)
B: Change in HbA1c From Baseline to Week 26 (Day 1 (Baseline) and Week 26)
C: Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death. (Up to 38.2 months)
D: Adjusted Mean Change in HbA1c Levels (Baseline to Week 24); Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit (Baseline to week 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Infant Nutrition: Evaluation of an Educational Touchscreen Computer Program for Use in a Spanish-speaking Population of Caregivers of Young Children (APA Phase II)
Brief Summary: The investigators are recruiting participants for a randomized controlled trial to evaluate the usability and educational value of a nutrition education touchscreen computer program targeting Spanish-speaking Latina caregivers of children 2 and under.

Participants will be randomized to the intervention group - use the computer program and the control group - do not use the program. They will be asked basic demographic questions, nutrition knowledge questions and computer users will be asked usability questions.

Objectives are

1. Evaluate the subjective and objective usability of the touchscreen computer.
2. Determine whether health knowledge on nutrition topics is enhanced through the use of the computer modules.


Options:
A: To determine the effect of a phosphorus additives educational intervention on serum phosphorus levels. (3 months)
B: HbA1c (30 Weeks)
C: Number of participants who adhere to mammography and Papanicolaou(Pap) test screening guidelines (6 months)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Infant Nutrition: Evaluation of an Educational Touchscreen Computer Program for Use in a Spanish-speaking Population of Caregivers of Young Children (APA Phase II)
Brief Summary: The investigators are recruiting participants for a randomized controlled trial to evaluate the usability and educational value of a nutrition education touchscreen computer program targeting Spanish-speaking Latina caregivers of children 2 and under.

Participants will be randomized to the intervention group - use the computer program and the control group - do not use the program. They will be asked basic demographic questions, nutrition knowledge questions and computer users will be asked usability questions.

Objectives are

1. Evaluate the subjective and objective usability of the touchscreen computer.
2. Determine whether health knowledge on nutrition topics is enhanced through the use of the computer modules.


Options:
A: N/A
B: Linear growth: Mean change from baseline in length-for-age Z-scores at at 9-, 12- and 15-months-old (Length-for-age Z-scores: Baseline (6 months-old), Month 9, Month 12 and Month 15)
C: Breastfeeding Initiation (Three days postpartum); Positive parenting behavior (Parent Child Observation Guide) (4 months postpartum)
D: Exclusive breastfeeding (EBF) among children 0-6 months of age (4 years after baseline); Child anthropometry (height, weight) among children 24-48 months of age (4 years after baseline); Complementary feeding among children 6-23.9 months of age (4 years after baseline); Anemia among children 6-23.9 months (4 years after baseline)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Azithromycin for Preventing the Development of Upper Respiratory Tract Illness Into Lower Respiratory Tract Symptoms in Children and Oral Corticosteroids for Treating Episodes of Significant Lower Respiratory Tract Symptoms in Children
Brief Summary: This protocol is comprised of two separate, but linked, clinical trials for treating preschool-aged children with recurrent severe episodes of wheezing. The first study (APRIL) will try to prevent wheezing illness from developing using azithromycin. If a wheezing illness does occur, the second trial (OCELOT) will try to decrease the severity of symptoms using oral corticosteroids.


Options:
A: Diary card summary symptom score (10 days after randomisation)
B: To measure and compare reduction in the concentration of lower airway bacteria in patients with COPD between three different antibiotic regimes and placebo (Week 14 post treatment)
C: Percentage Reduction From Baseline in Oral Corticosteroids (OCS) Dose at Week 24 While Maintaining Asthma Control (Baseline, Week 24); Supplementary Presentation of Primary Outcome Measure Data: Median Percentage Reduction From Baseline in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control (Baseline, Week 24)
D: Progression to Clinically Significant Lower Respiratory Tract Symptoms (14 days after initiation of APRIL therapy); OCELOT: Pediatric Respiratory Assessment Measure (36-72 hours after initiation of OCELOT therapy)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Azithromycin for Preventing the Development of Upper Respiratory Tract Illness Into Lower Respiratory Tract Symptoms in Children and Oral Corticosteroids for Treating Episodes of Significant Lower Respiratory Tract Symptoms in Children
Brief Summary: This protocol is comprised of two separate, but linked, clinical trials for treating preschool-aged children with recurrent severe episodes of wheezing. The first study (APRIL) will try to prevent wheezing illness from developing using azithromycin. If a wheezing illness does occur, the second trial (OCELOT) will try to decrease the severity of symptoms using oral corticosteroids.


Options:
A: Airflow decline (AFD)-free survival (2 year after allogeneic HSCT)
B: Re-hospitalization or Death (6 months)
C: Progression to Clinically Significant Lower Respiratory Tract Symptoms (14 days after initiation of APRIL therapy); OCELOT: Pediatric Respiratory Assessment Measure (36-72 hours after initiation of OCELOT therapy)
D: Comparison of number of participants with very good partial response or better response after three courses of VCD combined with clarithromycin or placebo (10 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Rehabilitation and Coping of Effects After Curative Radiotherapy for Prostate
Brief Summary: This project will test and evaluate a rehabilitation programme, which will empower the mens health and give them resources to face at new everyday life.

The project examines if a focused interdisciplinary intervention has influence of the patients generic and specified quality of life after curative radiotherapy due to prostate cancer.

The intervention contains nursing consultation with information about late side effects, an individual plan and counselling in toilet habits, smoking cessation, weight control and psychological problems after treatment. Furthermore the patients are having physiotherapy with pelvic floor examinations. The nurse can refer to other collaborators.


Options:
A: HRQOL urinary irritative score (12 month)
B: self reported continence (no need for wearing a pad)at 3 months (One year)
C: Percent Change in Incontinence Episodes on Bladder Diary (2 months); Percent Change in Incontinence Episodes Per Week on Bladder Diary (1 year)
D: Erectile function score by a validated symptom questionnaire (IIEF) (At 3 months, 6 months and 1 year); Time to continence after surgery (At 3 months, 6 months and 1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Rehabilitation and Coping of Effects After Curative Radiotherapy for Prostate
Brief Summary: This project will test and evaluate a rehabilitation programme, which will empower the mens health and give them resources to face at new everyday life.

The project examines if a focused interdisciplinary intervention has influence of the patients generic and specified quality of life after curative radiotherapy due to prostate cancer.

The intervention contains nursing consultation with information about late side effects, an individual plan and counselling in toilet habits, smoking cessation, weight control and psychological problems after treatment. Furthermore the patients are having physiotherapy with pelvic floor examinations. The nurse can refer to other collaborators.


Options:
A: Cancer patient's quality of life (QOL) as measured by the FACT-G global summary score (At baseline and 4, 27, and 52 weeks)
B: HRQOL urinary irritative score (12 month)
C: Fatigue measured by Fatigue Assessment Questionnaire (FAQ) (change between baseline and week 13 (end of intervention))
D: feasibility of isometric exercise in vertebral bony metastases (12 weeks post completion of radiotherapy)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial of Oxygen Therapy in Acute Myocardial Infarction (AVOID - Air Verses Oxygen In myocarDial Infarction Study)
Brief Summary: - Aim

The AVOID (Air Verses Oxygen In myocardial infarction) trial is designed to determine if the withholding of routine oxygen therapy in patients with acute heart attack leads to reduced heart damage compared to the current practice of routine inhaled oxygen for all patients.

- Background

There is evidence supporting and refuting the current practice of providing oxygen to all patients with acute heart attack. A recent summary of clinical trials suggested that oxygen may increase the degree of heart damage during heart attack. It also highlighted that the few trials into oxygen therapy were performed before the use of modern medications and procedures to treat heart attack and that further studies were urgently needed, using contemporary practices.

- Design

A total of 334 patients will participate in this randomized controlled trial. Patients in this study will receive the best current management and care for their condition. Patients will be randomized to routine pre-hospital care with oxygen therapy vs pre-hospital care without oxygen therapy. Patients will then receive standard hospital care, aside from allocated oxygen or no oxygen therapy. The primary outcome measure of heart damage will be investigated using routine blood tests. With additional information gathered from other aspects of routine heart care including coronary angiogram, electrocardiograms and complications of hospital stay. Patients will be followed up at 6 months to determine any longer term effects of treatment.


Options:
A: Myocardial Infarct Size (At 72 hours post infarct)
B: Mortality in ICU (30 days)
C: Surgical wound infection (14 days after surgery)
D: all-cause mortality (day 28)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial of Oxygen Therapy in Acute Myocardial Infarction (AVOID - Air Verses Oxygen In myocarDial Infarction Study)
Brief Summary: - Aim

The AVOID (Air Verses Oxygen In myocardial infarction) trial is designed to determine if the withholding of routine oxygen therapy in patients with acute heart attack leads to reduced heart damage compared to the current practice of routine inhaled oxygen for all patients.

- Background

There is evidence supporting and refuting the current practice of providing oxygen to all patients with acute heart attack. A recent summary of clinical trials suggested that oxygen may increase the degree of heart damage during heart attack. It also highlighted that the few trials into oxygen therapy were performed before the use of modern medications and procedures to treat heart attack and that further studies were urgently needed, using contemporary practices.

- Design

A total of 334 patients will participate in this randomized controlled trial. Patients in this study will receive the best current management and care for their condition. Patients will be randomized to routine pre-hospital care with oxygen therapy vs pre-hospital care without oxygen therapy. Patients will then receive standard hospital care, aside from allocated oxygen or no oxygen therapy. The primary outcome measure of heart damage will be investigated using routine blood tests. With additional information gathered from other aspects of routine heart care including coronary angiogram, electrocardiograms and complications of hospital stay. Patients will be followed up at 6 months to determine any longer term effects of treatment.


Options:
A: oxygen saturation ≥90% (baseline)
B: Surgical wound infection (14 days after surgery)
C: Neuron-specific enolase (NSE) serum concentration (48 hour after cardiac arrest)
D: Myocardial Infarct Size (At 72 hours post infarct)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial of Oxygen Therapy in Acute Myocardial Infarction (AVOID - Air Verses Oxygen In myocarDial Infarction Study)
Brief Summary: - Aim

The AVOID (Air Verses Oxygen In myocardial infarction) trial is designed to determine if the withholding of routine oxygen therapy in patients with acute heart attack leads to reduced heart damage compared to the current practice of routine inhaled oxygen for all patients.

- Background

There is evidence supporting and refuting the current practice of providing oxygen to all patients with acute heart attack. A recent summary of clinical trials suggested that oxygen may increase the degree of heart damage during heart attack. It also highlighted that the few trials into oxygen therapy were performed before the use of modern medications and procedures to treat heart attack and that further studies were urgently needed, using contemporary practices.

- Design

A total of 334 patients will participate in this randomized controlled trial. Patients in this study will receive the best current management and care for their condition. Patients will be randomized to routine pre-hospital care with oxygen therapy vs pre-hospital care without oxygen therapy. Patients will then receive standard hospital care, aside from allocated oxygen or no oxygen therapy. The primary outcome measure of heart damage will be investigated using routine blood tests. With additional information gathered from other aspects of routine heart care including coronary angiogram, electrocardiograms and complications of hospital stay. Patients will be followed up at 6 months to determine any longer term effects of treatment.


Options:
A: Myocardial Infarct Size (At 72 hours post infarct)
B: A single SPECT scan will be used to determine whether or not the treatment results in a significant reduction in infarct size in the treatment group. The scan is performed 14 days post-event. (14 +/- 7 days); Safety will be determined by comparing 30-day MACE (Major Adverse Cardiac Events) rates, where MACE is comprised by the combined incidence of death, stroke, repeat MI, and target vessel revascularization. (30 days)
C: Chest pain measured with VAS (1 h)
D: 1-year all-cause mortality (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial of Oxygen Therapy in Acute Myocardial Infarction (AVOID - Air Verses Oxygen In myocarDial Infarction Study)
Brief Summary: - Aim

The AVOID (Air Verses Oxygen In myocardial infarction) trial is designed to determine if the withholding of routine oxygen therapy in patients with acute heart attack leads to reduced heart damage compared to the current practice of routine inhaled oxygen for all patients.

- Background

There is evidence supporting and refuting the current practice of providing oxygen to all patients with acute heart attack. A recent summary of clinical trials suggested that oxygen may increase the degree of heart damage during heart attack. It also highlighted that the few trials into oxygen therapy were performed before the use of modern medications and procedures to treat heart attack and that further studies were urgently needed, using contemporary practices.

- Design

A total of 334 patients will participate in this randomized controlled trial. Patients in this study will receive the best current management and care for their condition. Patients will be randomized to routine pre-hospital care with oxygen therapy vs pre-hospital care without oxygen therapy. Patients will then receive standard hospital care, aside from allocated oxygen or no oxygen therapy. The primary outcome measure of heart damage will be investigated using routine blood tests. With additional information gathered from other aspects of routine heart care including coronary angiogram, electrocardiograms and complications of hospital stay. Patients will be followed up at 6 months to determine any longer term effects of treatment.


Options:
A: Myocardial Infarct Size (At 72 hours post infarct)
B: 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
C: %/type Surgical wound infections rated per infection classifications of NNIS/CDC (with in 30 days post-op)
D: Surgical wound infection (14 days after surgery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitive-Behavioral Treatment for Patients With Mild Alzheimer's Dementia: A Randomized Controlled Trial
Brief Summary: The purpose of this study is to determine whether a comprehensive cognitive-behavioral therapy-based, multi-component treatment programme is effective in the treatment of neuropsychiatric symptoms of patients with mild Alzheimer's dementia.


Options:
A: Fear of falling (Prospective change from baseline to end of intervention (8 weeks)); Functional mobility (Prospective change from baseline to end of intervention (8 weeks))
B: Change from baseline in Geriatric Depression Scale (GDS) (Pre-treatment, posttreatment (expected average of 9 months after protreatment), 6- and 12-months follow-up)
C: Primary outcomes are number of falls and falls rates as well as number and incidence of injurious falls measured by monthly fall calendars (24 months)
D: First Adjudicated Serious Fall-Related Injury (Enrollment through last completed follow-up or death interview (max 44 months))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitive-Behavioral Treatment for Patients With Mild Alzheimer's Dementia: A Randomized Controlled Trial
Brief Summary: The purpose of this study is to determine whether a comprehensive cognitive-behavioral therapy-based, multi-component treatment programme is effective in the treatment of neuropsychiatric symptoms of patients with mild Alzheimer's dementia.


Options:
A: Incidence of depression or anxiety disorders (15 months)
B: Change in psychological flexibility measured with the Acceptance and action questionnaire (AAQ2) (Measurement 1: 1 week prior to the intervention. Measurement 2: Change in AAQ2 from pre-intervention at 1 week post-intervention. Measurement 3: Change in AAQ2 from 1 week post-intervention at 6-month post intervention.)
C: Change from baseline in Geriatric Depression Scale (GDS) (Pre-treatment, posttreatment (expected average of 9 months after protreatment), 6- and 12-months follow-up)
D: Minutes of exercise per week (Change from baseline in number of minutes of exercise each week during treatment phase of study, weeks 7-12); Restricted Activity Days (Baseline); Restricted Activity Days (Change from Baseline to Pre-Treatment (6 weeks)); Restricted Activity Days (Change from Baseline to Post- Treatment 1 (13 weeks)); Restricted Activity Days (Change from Baseline to Post-Treatment 2 (30 weeks)); Restricted Days of Activity (Change from Baseline to 13 Month Follow-Up); Independence/Residential Status (Change from Baseline to 13 Month Follow-Up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate Efficacy and Safety of Treatment With CNTO 136 Administered Intravenously in Subjects With Active Lupus Nephritis
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of CNTO 136 administered intravenously in patients with active, International Society of Nephrology/Renal Pathology Society Class III and IV Lupus Nephritis (LN).


Options:
A: Efficacy of enteric-coated Mycophenolate Sodium at 12 months in the treatment of lupus nephritis (12 months)
B: Assessment of Primary Renal Response (12 months)
C: remission rate (month 6)
D: Number of patients with reduction in proteinuria (measurement of total urine protein greater than 0.5 g/24-hours, or a urine protein to creatinine ratio greater than 0.5 mg/mg) (Baseline to Week 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Steroids in Pediatric Acute Lung Injury/ARDS Trial: A Blinded, Placebo-controlled, Randomized Clinical Trial
Brief Summary: Acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) are devastating disorders associated with lung inflammation, low oxygen levels and respiratory failure in children. Prevalence of ALI ranges from 2.2 to 12 per 100,000 children per year. Using these estimates, up to 9,000 children each year will develop ALI/ARDS, which may cause upto 2,000 deaths per year. Currently, there are no specific therapies directed against ARDS/ALI in children. In adult patients, use of steroids early in the course of ARDS appears promising. There are no published clinical trials examining the use of steroids for the treatment of ALI/ARDS in children.

Hypothesis:

Subjects with ALI/ARDS receiving steroids early in the course of disease (within 72 hours) and longer than 7 days will have improved clinical outcomes as compared to placebo control group as defined by (a) a decreased duration of mechanical ventilation and (b) significantly increased PaO2/FiO2 ratios.


Options:
A: rate of hospital acquired pneumonia (day-28)
B: Number of patients who do not receive any more catecholamine 4 days after the beginning of the shock
C: 28-day Mortality (28 days)
D: Duration of mechanical ventilation (0-28 days)

Answer: D