TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Childhood Asthma Research and Education (CARE) Network Trial - Treating Children to Prevent Exacerbations of Asthma (TREXA)
Brief Summary: Asthma is a common, serious illness among children in the United States. It can be effectively controlled through the use of preventative medications and "rescue" medications, which are used to control symptoms. This study will evaluate the impact and severity of asthma exacerbations that occur in children with mild persistent asthma who are receiving various combinations of medications for daily and rescue use.


Options:
A: Participants Experiencing an Asthma Exacerbation That Requires Systemic Corticosteroid Therapy (Measured during the 44-week treatment period)
B: The Percentage of Participants Who Had Experienced Asthma Exacerbation(s) at the End of the Study (week 52)
C: Asthma control assessed by asthma exacerbations (Continuosly throughout the treatment period)
D: Change in PD20 histamine

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Childhood Asthma Research and Education (CARE) Network Trial - Treating Children to Prevent Exacerbations of Asthma (TREXA)
Brief Summary: Asthma is a common, serious illness among children in the United States. It can be effectively controlled through the use of preventative medications and "rescue" medications, which are used to control symptoms. This study will evaluate the impact and severity of asthma exacerbations that occur in children with mild persistent asthma who are receiving various combinations of medications for daily and rescue use.


Options:
A: time to first moderate or severe asthma exacerbation. (24 weeks)
B: Participants Experiencing an Asthma Exacerbation That Requires Systemic Corticosteroid Therapy (Measured during the 44-week treatment period)
C: N/A
D: Subject's height measured w. standard stadiometry techniques. 4 acceptable serial measurements taken at each visit on same equipment by a qualified technician.Median of 4 measurements used the subject's stadiometer height data

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Childhood Asthma Research and Education (CARE) Network Trial - Treating Children to Prevent Exacerbations of Asthma (TREXA)
Brief Summary: Asthma is a common, serious illness among children in the United States. It can be effectively controlled through the use of preventative medications and "rescue" medications, which are used to control symptoms. This study will evaluate the impact and severity of asthma exacerbations that occur in children with mild persistent asthma who are receiving various combinations of medications for daily and rescue use.


Options:
A: The proportion of upper respiratory tract infections (URTIs) in each group requiring treatment with systemic corticosteroids as confirmed by review of medical records and pharmacy records of prescriptions dispensed.
B: Participants Experiencing an Asthma Exacerbation That Requires Systemic Corticosteroid Therapy (Measured during the 44-week treatment period)
C: Change in PD20 histamine
D: Time to first severe asthma exacerbation

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Childhood Asthma Research and Education (CARE) Network Trial - Treating Children to Prevent Exacerbations of Asthma (TREXA)
Brief Summary: Asthma is a common, serious illness among children in the United States. It can be effectively controlled through the use of preventative medications and "rescue" medications, which are used to control symptoms. This study will evaluate the impact and severity of asthma exacerbations that occur in children with mild persistent asthma who are receiving various combinations of medications for daily and rescue use.


Options:
A: The Number of Participants With a Differential Response to the Three Step-up Therapies Based on Fixed Threshold Criteria for the Following Three Asthma Control Measures: Use of Oral Prednisone for Acute Asthma Exacerbations, Asthma Control Days and FEV1. (Measured during the last 12 weeks of each 16-week treatment period)
B: time to first moderate or severe asthma exacerbation. (24 weeks)
C: Participants Experiencing an Asthma Exacerbation That Requires Systemic Corticosteroid Therapy (Measured during the 44-week treatment period)
D: The proportion of upper respiratory tract infections (URTIs) in each group requiring treatment with systemic corticosteroids as confirmed by review of medical records and pharmacy records of prescriptions dispensed.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: DOUBLE BLIND, MULTINATIONAL, MULTICENTRE, PARALLEL-GROUP DESIGN CLINICAL TRIAL OF THE EFFICACY AND TOLERABILITY OF CHF 1535 (BECLOMETHASONE DIPROPIONATE 100 µg + FORMOTEROL 6 µg) pMDI VIA HFA-134a vs. FLUTICASONE 125 µg + SALMETEROL 25 µg pMDI (SERETIDE®) IN THE 12-WEEK TREATMENT OF ADULT PATIENTS WITH MODERATE TO SEVERE PERSISTENT ASTHMA
Brief Summary: The aim of this study was to compare the efficacy and tolerability of the fixed combination beclomethasone/formoterol pMDI with that of fluticasone/salmeterol pMDI in patients with moderate to severe asthma


Options:
A: morning peak expiratory flow (PEF) daily measured by patients
B: Change From Baseline in Asthma Control Test (ACT) Total Score at Week 12 (Baseline and Week 12)
C: Change From Baseline in Clinic Visit Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period (Baseline and Week 24)
D: Percentage of Participants Who Have Either an Asthma Control Test (ACT) Total Score of >=20 or an Increase From Baseline of >=3 in ACT Total Score at Week 24. (Baseline (Day 0) and Week 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: DOUBLE BLIND, MULTINATIONAL, MULTICENTRE, PARALLEL-GROUP DESIGN CLINICAL TRIAL OF THE EFFICACY AND TOLERABILITY OF CHF 1535 (BECLOMETHASONE DIPROPIONATE 100 µg + FORMOTEROL 6 µg) pMDI VIA HFA-134a vs. FLUTICASONE 125 µg + SALMETEROL 25 µg pMDI (SERETIDE®) IN THE 12-WEEK TREATMENT OF ADULT PATIENTS WITH MODERATE TO SEVERE PERSISTENT ASTHMA
Brief Summary: The aim of this study was to compare the efficacy and tolerability of the fixed combination beclomethasone/formoterol pMDI with that of fluticasone/salmeterol pMDI in patients with moderate to severe asthma


Options:
A: morning peak expiratory flow (PEF) daily measured by patients
B: Time-to-First Serious Asthma Outcomes (SAO): Number of First SAO in the MF/F vs MF Arms (26 weeks, or 7 days after the last treatment dose, whichever occurred later)
C: The Area Under the Curve From 0 to 12 Hours [AUC](0-12 hr) of the Change From Baseline to the Week 12 Endpoint in Forced Expiratory Volume in One Second (FEV1) (Baseline to Week 12)
D: Asthma control assessed by asthma exacerbations (Continuosly throughout the treatment period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: DOUBLE BLIND, MULTINATIONAL, MULTICENTRE, PARALLEL-GROUP DESIGN CLINICAL TRIAL OF THE EFFICACY AND TOLERABILITY OF CHF 1535 (BECLOMETHASONE DIPROPIONATE 100 µg + FORMOTEROL 6 µg) pMDI VIA HFA-134a vs. FLUTICASONE 125 µg + SALMETEROL 25 µg pMDI (SERETIDE®) IN THE 12-WEEK TREATMENT OF ADULT PATIENTS WITH MODERATE TO SEVERE PERSISTENT ASTHMA
Brief Summary: The aim of this study was to compare the efficacy and tolerability of the fixed combination beclomethasone/formoterol pMDI with that of fluticasone/salmeterol pMDI in patients with moderate to severe asthma


Options:
A: Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period (Baseline and Week 24); Change From Baseline in Weighted Mean Serial FEV1 Over 0-24 Hours Post-dose at Week 24 (Baseline and Week 24)
B: Change From Baseline in Weighted Mean Forced Expiratory Volume in One Second (FEV1) Over 0 to 24 Hours Post-dose at the End of the 12-week Treatment Period (Baseline and Week 12)
C: morning peak expiratory flow (PEF) daily measured by patients
D: Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total Score (Baseline and Week 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparative Trial Between Insulin Glargine Plus Supplemental Glulisine (Apidra) Versus Sliding Scale Regular Insulin In Hospitalized Patients With Type 2 Diabetes
Brief Summary: High blood glucose levels in hospitalized patients with diabetes are associated with increased risk of medical complications. Improved glucose control with insulin injections may improve clinical outcome and prevent some of the hospital complications. It is not known; however, what is the best insulin regimen in hospitalized patients. The use of repeated injections of regular insulin (known as sliding scale regimen) is one of the most commonly used insulin regimen for glucose control in hospitalized patients with diabetes. Recently, the combination of basal and rapid acting insulins has been shown to improve glucose control with lower rate of hypoglycemia (low blood sugar).


Options:
A: Mean Blood Glucose Concentration (hospital stay days 2-10)
B: The primary outcome to be studied is the frequency and severity of hyperglycemia and hypoglycemia in each group; Time to mean 24 hour plasma glucose < 180 mg/dl
C: Number of Participants With a Favorable Modified Rankin Scale (Yes/No) (90 days (-14/+30 days)); Number of Participants With Severe Hypoglycemia (Blood Glucose < 40mg/dL) (72 hours)
D: blood glucose control (During hospitalization)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessing Novel Methods of Improving Patient Education of Nutrition: eHealth, Health Literacy and Chronic Kidney Disease
Brief Summary: The relationship between elevated phosphorus levels and morbidity and mortality in patients with chronic kidney disease (CKD) is well recognized, and dietary phosphorus restriction is a mainstay of phosphate management. Current study is an effort to test the effect of a web-based nutritional educational intervention, Kidney School(KS), to improve phosphorous knowledge and control phosphorous intake in CKD patients.


Options:
A: Gain in phosphorus knowledge as assessed by the chronic kidney disease Knowledge Assessment Tool (CKDKAT) of nutrition. (4 to 8 weeks post intial questionnaire/survey); Compliance with dietary phosphorous will be measured by serum phosphorous level. (4 to 8 weeks after initial questionnaire/survey appointment); Compliance with dietary phosphorous will be measured by serum calcium level (4 to 8 weeks after initial questionaire/survey appointment); Compliance with dietary phosphorous will be measured by para thyroid hormone (PTH) level (4 to 8 weeks after initial questionnaire/survey appointment); Compliance with dietary phosphorous will be measured by serum calcium phosphorus product. (4 to 8 weeks after initial questionnaire/survey appointment); Compliance with dietary phosphorus intake will be measured by using 24 hour recall diary. (4 to 8 weeks after initial questionnaire/survey appointment)
B: Body weight (4 months); Physical activity (4 months); Caloric intake (4 month)
C: Change in blood pressure measurement at baseline and at one year follow-up (Baseline and one year follow-up)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessing Novel Methods of Improving Patient Education of Nutrition: eHealth, Health Literacy and Chronic Kidney Disease
Brief Summary: The relationship between elevated phosphorus levels and morbidity and mortality in patients with chronic kidney disease (CKD) is well recognized, and dietary phosphorus restriction is a mainstay of phosphate management. Current study is an effort to test the effect of a web-based nutritional educational intervention, Kidney School(KS), to improve phosphorous knowledge and control phosphorous intake in CKD patients.


Options:
A: Number of Control and Intervention Participants on Skin Self-examination Performance at Follow-up 1 Month After Intervention (1 month)
B: Change in Medication Knowledge Score from baseline to 3 months (Baseline and 3 months)
C: enhancing rates of family communication, donor evaluations, and transplantation (6 months)
D: Gain in phosphorus knowledge as assessed by the chronic kidney disease Knowledge Assessment Tool (CKDKAT) of nutrition. (4 to 8 weeks post intial questionnaire/survey); Compliance with dietary phosphorous will be measured by serum phosphorous level. (4 to 8 weeks after initial questionnaire/survey appointment); Compliance with dietary phosphorous will be measured by serum calcium level (4 to 8 weeks after initial questionaire/survey appointment); Compliance with dietary phosphorous will be measured by para thyroid hormone (PTH) level (4 to 8 weeks after initial questionnaire/survey appointment); Compliance with dietary phosphorous will be measured by serum calcium phosphorus product. (4 to 8 weeks after initial questionnaire/survey appointment); Compliance with dietary phosphorus intake will be measured by using 24 hour recall diary. (4 to 8 weeks after initial questionnaire/survey appointment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Resuscitation Outcomes Consortium (ROC) Prehospital Resuscitation Using an Impedance Valve and Early Versus Delayed Analysis
Brief Summary: The purpose of this study is to look at two different treatments during a cardiac arrest that occurs outside of the hospital and whether either or both treatments will increase the number of people who live to hospital discharge. A cardiac arrest is when the heart stops pumping blood to the body.


Options:
A: Survival to Hospital Discharge With Satisfactory Function (Modified Rankin Scale [MRS] of Less Than or Equal to 3). (Hospital discharge or death prior to discharge)
B: Four hour survival from successful restoration of spontaneous circulation. (Four hours survival)
C: Hospital admission defined as being alive four hours after the call for assistance to the emergency dispatch center.
D: Number of Patients Who Survived to Hospital Discharge With Favorable Neurologic Function Defined as MRS Score <=3 (When the subject is discharged from the hospital; an average of 12 days after cardiac arrest for subjects surviving to hospital discharge)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Lumbar Disc Prosthesis Versus Multidisciplinary Rehabilitation Program in Patients With Chronic Low Back Pain and Degenerative Disc. A Prospective Randomized Clinical Multicentre Trial.
Brief Summary: Surgical methods offered to patients with chronic low back pain are controversial. In addition, new and expensive treatment methods like total disc replacemet (TDR) are a challenge for the health care services. At present, ongoing randomized studies in both Europe and USA are comparing TDR to fusion. However, to our knowledge, no randomized trials have compared TDR to non-surgical treatment. The aim of the present study is to evaluate the effect of a comprehensive and structured non-surgical treatment with TDR surgery in patients with chronic low back pain and localized degenerative disc changes.

Main hypothesis: There is no difference in treatment effect between surgery with lumbar total disc prosthesis and a multidisciplinary rehabilitation program measured by Oswestry Disability Index after 1 and 2 years.

Secondary hypothesis: There is no difference in cost - effectiveness between surgery with lumbar disc prosthesis and a multidisciplinary rehabilitation program after 1 and 2 years.


Options:
A: Oswestry Disability Index; Cost-effectiveness (full economic analysis)
B: Return-to-work=the proportion of patients who during 1-18 months regained a degree of work ability>0 for at least 30 days in succession. (18 months.)
C: Pain intensity (Measured at Week 4 and Month 6); Pain-related disability (Measured at Week 4 and Month 6)
D: pain; disability; fatigue; psychological distress at post treatment and 6 month follow-up

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Lumbar Disc Prosthesis Versus Multidisciplinary Rehabilitation Program in Patients With Chronic Low Back Pain and Degenerative Disc. A Prospective Randomized Clinical Multicentre Trial.
Brief Summary: Surgical methods offered to patients with chronic low back pain are controversial. In addition, new and expensive treatment methods like total disc replacemet (TDR) are a challenge for the health care services. At present, ongoing randomized studies in both Europe and USA are comparing TDR to fusion. However, to our knowledge, no randomized trials have compared TDR to non-surgical treatment. The aim of the present study is to evaluate the effect of a comprehensive and structured non-surgical treatment with TDR surgery in patients with chronic low back pain and localized degenerative disc changes.

Main hypothesis: There is no difference in treatment effect between surgery with lumbar total disc prosthesis and a multidisciplinary rehabilitation program measured by Oswestry Disability Index after 1 and 2 years.

Secondary hypothesis: There is no difference in cost - effectiveness between surgery with lumbar disc prosthesis and a multidisciplinary rehabilitation program after 1 and 2 years.


Options:
A: Return-to-work=the proportion of patients who during 1-18 months regained a degree of work ability>0 for at least 30 days in succession. (18 months.)
B: Pain VAS
C: Oswestry Disability Index; Cost-effectiveness (full economic analysis)
D: Adjusted Change in Pain-related Function (Roland Disability Score) (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Surgical Procedures in Vulvar and Vaginal Dysplasias
Brief Summary: 1. To compare the recurrence rate between the use of laser vaporization and ultrasonic surgical aspiration in the treatment of vulvar and vaginal dysplasias
2. To compare healing related complications, post-operative pain, and scarring between the two procedures.


Options:
A: Proportion of Patients With Regression of Perianal High-grade Squamous Intraepithelial Lesions (HSIL) (6 weeks after treatment discontinuation); Safety and Tolerability of Topical Cidofovir as Assessed by NCI CTCAE v3.0 (Every 2 weeks on study, 6 weeks after treatment discontinuation)
B: Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN)(Any Grade), Adenocarcinoma In Situ (AIS) or Cervical Cancer (Follow-up through end of study (4 years)); Incidence of HPV 6/11/16/18-related External Genital Lesions (EGL) [Genital Warts, Vulvar/Vaginal Intraepithelial Neoplasia (Any Grade), Vulvar/Vaginal Cancer] (Follow-up through end of study (4 years))
C: recurrence rate
D: Incidence of the Composite Endpoint of Human Papillomavirus (HPV) 16/18-related Cervical Intraepithelial Neoplasia (CIN) 2 or Worse in the Base Study (Up to 4 years); Incidence of the Composite Endpoint of Human Papillomavirus (HPV) 16/18-related Cervical Intraepithelial Neoplasia (CIN) 2 or Worse in the Long-term Follow-up (LTFU) Study (Up to 14 years since Vaccine Dose 1); Incidence of the Composite Endpoint of HPV16/18-related CIN 2 or Worse in the Long-term Follow-up (LTFU) Study (up to 22 years post Vaccination Dose 1)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-label, Multicentric Parallel Group Study to Assess the Impact of Supportive Measures on the Drug Adherence of Patients With Essential Hypertension Treated With Valsartan or Valsartan Plus HCTZ for 34 Weeks With or Without Respective Measures
Brief Summary: The purpose of this study is to assess the impact of supportive measures on the drug adherence of patients with essential hypertension


Options:
A: Impact of personalized risk information (baseline); Impact of personalized risk information (3 month)
B: Average number of missed pills per cycle (3 months)
C: Understanding (Directly proceeding the clinical encounter); Decisional Conflict (Directly proceeding the clinical visit); Treatment Action, adherence (Directly proceeding the clinical encounter, 6 months after the clinical encounter)
D: Drug adherence in patients (daily proportion of patients taking one tablet of the prescribed hypertensive therapy as prescribed)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Controlled, Open Label, Multicenter, Parallel-group Study to Compare the Effect of Mircera With That of Darbepoetin Alfa, Administered Intravenously at Extended Dosing Intervals, for the Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Who Are on Hemodialysis
Brief Summary: This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa, administered at extended dosing intervals, in the maintenance treatment of anemia in patients with chronic kidney disease (CKD) who are on hemodialysis. Eligible patients receiving once-weekly intravenous (IV) darbepoetin alfa maintenance treatment will be randomized to receive either intravenous Mircera once a month (at a starting dose of 120, 200 or 360 micrograms/month, depending on the weekly dose of darbepoetin alfa prior to start of study) or intravenous darbepoetin alfa every 2 weeks before switching to once monthly administration. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Options:
A: Change From Baseline in Left Ventricle Mass Index (LVMI) at Month 15 (Baseline, Month 15)
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: 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))
D: Time to All-cause Mortality or Cardiovascular (CV) Events Including Hospitalization Due to Acute Myocardial Ischemia, Congestive Heart Failure (CHF), Myocardial Infarction (MI), and Cerebrovascular Accident (CVA) (Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first); Time to All-cause Mortality or End Stage Renal Disease (ESRD) (Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first)

Answer: C