TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Trial to Assess the Use of the Cypher TM Stent in Acute Myocardial Infarction Treated With Balloon Angioplasty
Brief Summary: The main objective of this study is to assess the effectiveness and safety of the CYPHER™ (CYPHER SELECT™) (Sirolimus-eluting) stent in reducing the occurrence of a composite endpoint of target vessel failure (TVF) in subjects treated for acute myocardial infarction as compared to a bare metal stent.


Options:
A: N/A
B: Composite of target vessel failure (TVF) defined as target vessel revascularization, recurrent myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vesselpost-procedure. (1 and 6 months and at 1, 3, 4, and 5 years post-procedure.)
C: The primary end point was target lesion revascularization (TLR) at 1-year follow-up (1 year)
D: Pharmacology Arm - Major Adverse Ischemic Cardiac Events and Major Bleeding Events (30 Days); Stent Arm - Ischemic Target Lesion Revascularization (1 year); Stent Arm - Death, Reinfarction, Stroke, or Stent Thrombosis (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III, Prospective, Open Label, Multicenter, Randomized Trial of Melphalan, Prednisone and Thalidomide Versus Melphalan and Prednisone as First Line Therapy in Myeloma Patients Aged >65.
Brief Summary: The purpose of this study is to determine whether the association of Thalidomide to Melphalan and Prednisone is effective in the treatment of newly diagnosed elderly multiple myeloma.


Options:
A: Time to progression
B: Response Rate; Progression Free Survival; Event Free Survival
C: Progression-Free Survival (From date of initial registration to date of progression/relapse of disease or death from any cause, whichever came first, up to 5 years)
D: The primary objective is to analyze and compare the efficacy, the response rate, the CR and the response rate duration of both induction treatments and both maintenance treatments (5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Duloxetine 60/120mg Versus Placebo in the Treatment of Fibromyalgia Syndrome
Brief Summary: To test the hypothesis that the efficacy and safety of duloxetine has beneficial effects of the reduction of pain severity as measured by the average pain item of the BPI and the PGI-I in patients with fibromyalgia syndrome.


Options:
A: assess efficacy of duloxetine (QD) vs placebo on pain in patients, w/ or w/o MDD during a 6-month therapy phase; evaluate change in pain measured by Brief Pain Inventory score; evaluate endpoint of patient-reported improvement on the Patient's Global Impression of Improvement scale
B: Patient's Global Impressions of Improvement (PGI-I) at Week 12 (12 weeks)
C: Change From Week 8 to Week 16 Endpoint in 24 Hour Average Pain Item Score on the Brief Pain Inventory (BPI) Modified Short Form (Week 8, Week 16)
D: Whether there is a reduction in subjective pain as assessed by the Brief Pain Inventory. (December 2008)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Duloxetine 60/120mg Versus Placebo in the Treatment of Fibromyalgia Syndrome
Brief Summary: To test the hypothesis that the efficacy and safety of duloxetine has beneficial effects of the reduction of pain severity as measured by the average pain item of the BPI and the PGI-I in patients with fibromyalgia syndrome.


Options:
A: Assessment of arthralgia scores and patients' compliance within the first year of anastrozole treatment, stratified by upfront and switch therapy as well as assessment of the relationship between compliance and arthralgia scores. (12 months)
B: Change in Musculoskeletal Symptom Sub-scale on the Breast Cancer Prevention Trial Symptom Scale (baseline to 6 months); Change in Hand Grip Strength (baseline to 6 months)
C: assess efficacy of duloxetine (QD) vs placebo on pain in patients, w/ or w/o MDD during a 6-month therapy phase; evaluate change in pain measured by Brief Pain Inventory score; evaluate endpoint of patient-reported improvement on the Patient's Global Impression of Improvement scale
D: Change in pain score based on the Brief Pain Inventory (BPI) (Baseline to up to 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: To evaluate the effectiveness of a Head Start-based early intervention for designed to improve asthma management skill and practices of parents, pre-school children and Head Start staff.


Options:
A: Percentage of Symptom-free Days During the Last 10 Weeks of the Treatment Period (Last 10 weeks of the treatment period (Weeks 16-26))
B: 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
C: N/A
D: Change From Baseline in Morning Peak Expiratory Flow (PEF) (Baseline and Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: To evaluate the effectiveness of a Head Start-based early intervention for designed to improve asthma management skill and practices of parents, pre-school children and Head Start staff.


Options:
A: Time until all-cause death or heart-failure hospitalization (Measured over the two years of study follow-up.)
B: Drug adherence in patients (daily proportion of patients taking one tablet of the prescribed hypertensive therapy as prescribed)
C: Percentage of Participants With Depression Treatment Response (6 months)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: To evaluate the effectiveness of a Head Start-based early intervention for designed to improve asthma management skill and practices of parents, pre-school children and Head Start staff.


Options:
A: N/A
B: Follow-up with a Primary Care Physician (PCP) (4 weeks, 3 months and 6 months after Emergency Department visit)
C: N/A
D: Symptom-free days; Quality of Life Questionnaire (AQLQ, PAQLQ); Rate of asthma-related hospitalizations over 18 months of enrollment; Rate of asthma-related emergency room (ER) visits over 18 months of enrollment

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: To evaluate the effectiveness of a Head Start-based early intervention for designed to improve asthma management skill and practices of parents, pre-school children and Head Start staff.


Options:
A: Change in Percentage of participants using controller medications for asthma from baseline to 12 month follow-up (Baseline, 12)
B: N/A
C: N/A
D: number of subjects who achieved Total asthma Control: Period 2 (Up to Week 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: CHD Lifestyle Modification for Latinas With Diabetes
Brief Summary: The Viva Bien! trial will comprehensively evaluate a multiple risk factor intervention (diet, physical activity, stress management, social support, and smoking cessation) in a randomized effectiveness trial, which will be offered in English and Spanish to diabetic Latinas.


Options:
A: Salivary Cotinine (12 months posttreatment)
B: Adherence to the Mediterranean Diet, physical activity, stress management, and smoking cessation protocols (Measured at baseline, 6, 12, and 24 months); Hemoglobin A1c (Measured at baseline, 6, 12, and 24 months)
C: Smoking Cue Reactivity on Quit Day (4-weeks)
D: Percentage of Participants Who Abstained From Smoking at 10 and 30 Weeks Post Quit Day (End of treatment (10 weeks post quit day) and 30-week follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT) in Extremely Low Birth Weight Infants
Brief Summary: This study compared the use of continuous positive airway pressure initiated at birth with the early administration of surfactant administered through a tube in the windpipe within 1 hour of birth for premature infants born at 24 to 27 weeks gestation. In addition, these infants within 2 hours of birth, had a special pulse oximeter placed to continuously monitor their oxygen saturation in two different target ranges (85-89% or 91-95%). This study helped determine whether or not these two management strategies affect chronic lung disease and survival of premature infants.


Options:
A: Survival without severe neurosensory disability to 18 to 21 months (corrected for prematurity) (18-21 months corrected for prematurity)
B: Percentage of Positive-Pressure Ventilation Inflations Between 4 - 8 Mls/kg (the first 15 minutes of resuscitation)
C: Proportion of time with SpO2 within target range (16 hours); Proportion of Time with SpO2 within target range (16 hours)
D: Survival Without Bronchopulmonary Dysplasia (BPD) (36 weeks); Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery) (55 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT) in Extremely Low Birth Weight Infants
Brief Summary: This study compared the use of continuous positive airway pressure initiated at birth with the early administration of surfactant administered through a tube in the windpipe within 1 hour of birth for premature infants born at 24 to 27 weeks gestation. In addition, these infants within 2 hours of birth, had a special pulse oximeter placed to continuously monitor their oxygen saturation in two different target ranges (85-89% or 91-95%). This study helped determine whether or not these two management strategies affect chronic lung disease and survival of premature infants.


Options:
A: Need for mechanical ventilation
B: Need for MV (Within the first 5 days of life)
C: Need for mechanical ventilation (Death or discharge from the NICU)
D: Survival Without Bronchopulmonary Dysplasia (BPD) (36 weeks); Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery) (55 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT) in Extremely Low Birth Weight Infants
Brief Summary: This study compared the use of continuous positive airway pressure initiated at birth with the early administration of surfactant administered through a tube in the windpipe within 1 hour of birth for premature infants born at 24 to 27 weeks gestation. In addition, these infants within 2 hours of birth, had a special pulse oximeter placed to continuously monitor their oxygen saturation in two different target ranges (85-89% or 91-95%). This study helped determine whether or not these two management strategies affect chronic lung disease and survival of premature infants.


Options:
A: Survival Without Bronchopulmonary Dysplasia (BPD) (36 weeks); Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery) (55 weeks)
B: Need for mechanical ventilation
C: Need for MV (Within the first 5 days of life)
D: Death or Chronic Lung Disease (at 36 weeks postmenstrual age); Death (36 weeks adjusted age)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT) in Extremely Low Birth Weight Infants
Brief Summary: This study compared the use of continuous positive airway pressure initiated at birth with the early administration of surfactant administered through a tube in the windpipe within 1 hour of birth for premature infants born at 24 to 27 weeks gestation. In addition, these infants within 2 hours of birth, had a special pulse oximeter placed to continuously monitor their oxygen saturation in two different target ranges (85-89% or 91-95%). This study helped determine whether or not these two management strategies affect chronic lung disease and survival of premature infants.


Options:
A: Need for mechanical ventilation (Death or discharge from the NICU)
B: Need for mechanical ventilation
C: Need for MV (Within the first 5 days of life)
D: Survival Without Bronchopulmonary Dysplasia (BPD) (36 weeks); Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery) (55 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT) in Extremely Low Birth Weight Infants
Brief Summary: This study compared the use of continuous positive airway pressure initiated at birth with the early administration of surfactant administered through a tube in the windpipe within 1 hour of birth for premature infants born at 24 to 27 weeks gestation. In addition, these infants within 2 hours of birth, had a special pulse oximeter placed to continuously monitor their oxygen saturation in two different target ranges (85-89% or 91-95%). This study helped determine whether or not these two management strategies affect chronic lung disease and survival of premature infants.


Options:
A: need for mechanical ventilation after the procedure (72hours)
B: Survival Without Bronchopulmonary Dysplasia (BPD) (36 weeks); Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery) (55 weeks)
C: Efficacy of nasal intermittent mandatory ventilation (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant treatment in preterm infants (3 months)
D: Death or physiological bronchopulmonary dysplasia (36 weeks post menstrual age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT) in Extremely Low Birth Weight Infants
Brief Summary: This study compared the use of continuous positive airway pressure initiated at birth with the early administration of surfactant administered through a tube in the windpipe within 1 hour of birth for premature infants born at 24 to 27 weeks gestation. In addition, these infants within 2 hours of birth, had a special pulse oximeter placed to continuously monitor their oxygen saturation in two different target ranges (85-89% or 91-95%). This study helped determine whether or not these two management strategies affect chronic lung disease and survival of premature infants.


Options:
A: Survival Without Bronchopulmonary Dysplasia (BPD) (36 weeks); Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery) (55 weeks)
B: change of medical management elicited by cerebral oxygenation out of range (0-72 hours of life)
C: Cerebral tissue oxygen saturation (crSO2) (15 minutes)
D: The burden of hypo- and hyperoxia (0-72 hours of life)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT) in Extremely Low Birth Weight Infants
Brief Summary: This study compared the use of continuous positive airway pressure initiated at birth with the early administration of surfactant administered through a tube in the windpipe within 1 hour of birth for premature infants born at 24 to 27 weeks gestation. In addition, these infants within 2 hours of birth, had a special pulse oximeter placed to continuously monitor their oxygen saturation in two different target ranges (85-89% or 91-95%). This study helped determine whether or not these two management strategies affect chronic lung disease and survival of premature infants.


Options:
A: Need for mechanical ventilation (Death or discharge from the NICU)
B: Death or Chronic Lung Disease (at 36 weeks postmenstrual age); Death (36 weeks adjusted age)
C: Survival Without Bronchopulmonary Dysplasia (BPD) (36 weeks); Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery) (55 weeks)
D: Need for MV (Within the first 5 days of life)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT) in Extremely Low Birth Weight Infants
Brief Summary: This study compared the use of continuous positive airway pressure initiated at birth with the early administration of surfactant administered through a tube in the windpipe within 1 hour of birth for premature infants born at 24 to 27 weeks gestation. In addition, these infants within 2 hours of birth, had a special pulse oximeter placed to continuously monitor their oxygen saturation in two different target ranges (85-89% or 91-95%). This study helped determine whether or not these two management strategies affect chronic lung disease and survival of premature infants.


Options:
A: Reduction in mean oxidative balance ratio at 1 hour of life (Cord blood and at 1 hour of life)
B: Survival without severe neurosensory disability to 18 to 21 months (corrected for prematurity) (18-21 months corrected for prematurity)
C: Survival Without Bronchopulmonary Dysplasia (BPD) (36 weeks); Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery) (55 weeks)
D: composite outcome of death or major disability by 18-24 months corrected age (by 18-24 months corrected age (gestational age plus chronological age))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT) in Extremely Low Birth Weight Infants
Brief Summary: This study compared the use of continuous positive airway pressure initiated at birth with the early administration of surfactant administered through a tube in the windpipe within 1 hour of birth for premature infants born at 24 to 27 weeks gestation. In addition, these infants within 2 hours of birth, had a special pulse oximeter placed to continuously monitor their oxygen saturation in two different target ranges (85-89% or 91-95%). This study helped determine whether or not these two management strategies affect chronic lung disease and survival of premature infants.


Options:
A: The primary outcome measure is reaching or not reaching failure criterion (FiO2= 65% while receiving nasal CPAP). (96 Hours)
B: Composite outcome of either a) early neonatal death or b) neonatal encephalopathy (Day 7 of life)
C: Survival Without Bronchopulmonary Dysplasia (BPD) (36 weeks); Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery) (55 weeks)
D: Number of Participants Failing to Avoid Invasive Mechanical Ventilation (120 hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT) in Extremely Low Birth Weight Infants
Brief Summary: This study compared the use of continuous positive airway pressure initiated at birth with the early administration of surfactant administered through a tube in the windpipe within 1 hour of birth for premature infants born at 24 to 27 weeks gestation. In addition, these infants within 2 hours of birth, had a special pulse oximeter placed to continuously monitor their oxygen saturation in two different target ranges (85-89% or 91-95%). This study helped determine whether or not these two management strategies affect chronic lung disease and survival of premature infants.


Options:
A: Incidence of respiratory morbidity (72 hours after birth)
B: Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity) (Birth to 28 days)
C: Survival Without Bronchopulmonary Dysplasia (BPD) (36 weeks); Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery) (55 weeks)
D: Neonatal Composite Outcome (72 hours of life)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Comparative, Controlled Phase III, Multicenter Study of Hexvix Fluorescence Cystoscopy and White Light Cystoscopy in the Detection Of Papillary Bladder Cancer and the Early Recurrence Rate in Patients With Bladder Cancer
Brief Summary: The purpose of this study is to document the additional detection of papillary bladder cancer and the reduced early recurrence due to the improved detection and resection of these tumors after Hexvix cystoscopy compared to standard cystoscopy in patients with papillary bladder cancer.


Options:
A: Compare the tumor recurrence rate at 12 months after TUR in patients with intermediate risk superficial bladder cancer treated with intravesical Gemcitabine or Mitomycin C.
B: Proportion of Patients With >= 1 Ta or T1 Tumor Detected With Blue Light and Not White Light (Day 0); Comparison of the Proportions of Patients in the White Light Cystoscopy and Hexvix Groups Who Underwent TURB for a Histologically-confirmed Ta or T1 Tumor Who Had a Recurrence ( CIS, Ta, T1 or T2-T4 Tumor) Within 9 Months. (9 months)
C: Proportion of Patients With Histologically Confirmed Malignancy Where Malignancy is Only Detected With Blue Light Cystoscopy With Cysview and Not White Light Cystoscopy (At time of cystoscopy procedure)
D: Number of Participants Without Grade ≥ 3 Adverse Event, Graded According to NCI CTCAE Version 4.03 (Two years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Placebo Controlled Double Blind Dose Ranging Study of the Efficacy and Safety of SSR149744C 50, 100, 200, or 300 mg OD, With Amiodarone as Calibrator for the Maintenance of Sinus Rhythm in Patients With Recent Atrial Fibrillation/Flutter
Brief Summary: Double blind study to evaluate the efficacy and tolerability of SSR149744C and select a dose to be further investigated in the maintenance of sinus rhythm after electrical, pharmacological or spontaneous conversion of AF/AFL.


Options:
A: Time to first documented recurrence of symptomatic sustained AF. (Time to first documented recurrence of symptomatic sustained AF within Day 90 of dosing); Safety assessments- Vital signs, safety laboratory assays, ECG parameters, physical examinations, and frequency of adverse events (Safety assessments within Day 120 of dosing)
B: The primary efficacy endpoint is the rate of conversion to sinus rhythm documented by ECG just before the planned electrical cardioversion on D3 i.e. after 48 hours following the first study drug administration.
C: Freedom from atrial arrhythmias, lasting more than 24 hours or requiring cardioversion. (1-year follow-up)
D: The primary endpoint is the time from randomization to first documented AF/AFL recurrence indicated by 12-lead ECG or trans-telephonic ECG monitoring tracings showing AF/AFL.

Answer: D