TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Collaborative Management of Hypertension
Brief Summary: The purpose of this study is to test whether blood pressure control can be improved by physician education and feedback provided through the development of physician/pharmacist collaborative teams.


Options:
A: Adherence to hypertension guidelines (Measured for two 6 month periods: the first is prior to the participant's enrollment in the study and the second is while the participant is enrolled in the study)
B: The number of patients that complete recommended laboratory monitoring within one week and twenty five days after intervention.; The study will evaluate the time to completion of the recommended labs.; The study will also evaluate PCP and patient experiences with the interventions in order to refine the interventions in the future.
C: Blood pressure control (Measured by zero blood pressure measurements at baseline and 2, 4, 6, 8, and 9 months)
D: Medication adherence; Exacerbation of heart failure; Health-related quality of life

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Tailored Asthma Management for Urban Teens
Brief Summary: The purpose of this project is to refine and further evaluate an online asthma management and education program for urban teenagers. This project is a continuation of Puff City I, a project piloting and evaluating a tailored, school-based, computerized asthma education program for urban teenagers. In this second phase of research, a new version of software (Puff City II) will be created that will target resistance to change and relapse, and using a tested, theory-based approach to student recruitment, conduct a randomized trial to test the efficacy of this new software.


Options:
A: Asthma-related morbidity (Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest)
B: Change in baseline asthma self efficacy after 3 weeks (participants will be followed for an average of 4 weeks, with this measure collect at the beginning of the period and after 3 weeks of reminders.)
C: Quality of life (6 months); Asthma Control (6 months)
D: Forced Expiratory Volume in the first second (FEV1 %) predicted value (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Tailored Asthma Management for Urban Teens
Brief Summary: The purpose of this project is to refine and further evaluate an online asthma management and education program for urban teenagers. This project is a continuation of Puff City I, a project piloting and evaluating a tailored, school-based, computerized asthma education program for urban teenagers. In this second phase of research, a new version of software (Puff City II) will be created that will target resistance to change and relapse, and using a tested, theory-based approach to student recruitment, conduct a randomized trial to test the efficacy of this new software.


Options:
A: Asthma-related morbidity (Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest)
B: Number of Unscheduled Healthcare Visits (UHCV) (4 months)
C: Asthma Exacerbations (12 months)
D: Appropriate use of asthma controller medications (Measured at Year 1); Number of asthma symptom days (Measured at Year 1)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Hypertension Improvement Project (HIP)
Brief Summary: This study will test the separate and combined effects of a continuous quality improvement (CQI) intervention for physicians (MDs) and a behavioral intervention for patients on blood pressure control.


Options:
A: Change in systolic blood pressure (6 months)
B: decreased of occured of iatrogenic event in ICU (one month)
C: EFFECT AMI Composite Quality Indicator in the year after report cards published (April 1, 2004 - March 31, 2005); EFFECT CHF Composite Quality Indicator in the year after report cards published (April 1, 2004 - March 31, 2005)
D: Extent of guideline adherence after approximately one year (measured by a specific set of guideline-derived indicators, formulated beforehand by the research group) (half year after intervention); Costs of both Implementation strategies (half year after intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial of GM-CSF in Patients With ALI/ARDS
Brief Summary: This study will test the hypothesis that administration of granulocyte-macrophage colony stimulating factor (GM-CSF) to patients with acute lung injury/acute respiratory distress syndrome (ALI/ARDS) will improve the clinical course and outcome by shortening the duration of mechanical ventilation for these patients.


Options:
A: Ventilator-free Days During Days 1-28 (Measured at Day 28)
B: change in extravascular lung water within 7 days of treatment (change from baseline - day 7)
C: N/A
D: Hospital Mortality to Day 60. (60 days after randomization)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Safety and Efficacy of the STARFlex® Septal Closure System Versus Best Medical Therapy in Patients With a Stroke and/or Transient Ischemic Attack Due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale
Brief Summary: The primary objective of the study is to determine whether the STARFlex® septal closure system will safely and effectively prevent a recurrent embolic stroke/transient ischemic attack (TIA) and mortality in patients with a PFO and to demonstrate superiority of the STARFlex® device compared to best medical therapy.


Options:
A: Two (2) year incidence of stroke or Hard TIA (2 years); All cause mortality for the first 30 days of follow up/discharge, whichever is longer (30 days); Neurological mortality from 31 days of follow up (F/U) or longer (31 days)
B: Evidence of clinically defined ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI (Mean follow up of 4 years); Evidence of hemorrhagic stroke; a neurologic deficit associated with intraparenchymal or subarachnoid space lesion on CT/MRI or cerebral hemorrhage demonstrated by surgery or autopsy. (within mean follow-up of 4 years)
C: Percentage of patients with the 3-month new vascular events, defined as any event of the following: Any stroke (ischemic or hemorrhage) (3 months)
D: Number of Participants With Composite of Stroke/MI/Death (From randomization up to 97 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of Stabilizing Exercises and Effect on Anticipatory Muscle Control in Patients With Subacute and Chronic Low Back Pain
Brief Summary: Muscular stability is essential to the spinal column to avoid harmful strain and injury to its structures. Sudden postural disturbances impose reactive internal forces through the spine. If the muscles do not react before the internal reactive forces propagate through the spine, there is a short fraction of time where the spinal column may lack sufficient muscular support. Studies have shown that in patients with low back pain deep abdominal and back muscle have a delayed response to reactive forces. The purpose of this study is to verify these findings and to investigate whether tailored interventions can improve the reaction time in stabilizing muscle around the lower spinal column i patients with subacute and chronic low back pain.


Options:
A: Average pain intensity (up to 12 weeks); Modified Roland Morris Disability Questionnaire for back pain-specific disability (up to 12 weeks)
B: Muscle activity onset in transversus abdominal muscle (1 year)
C: Timed Get-Up-And Go (Change from baseline to 12-week follow-up); PROMIS Health Assessment Questionnaire (Change from baseline to 12-week follow-up)
D: Pain (visual analogical scale and McGill pain questionnaire) (Six weeks); Functional disability (Oswestry disability questionnaire) (Six weeks); TrA muscle activation capacity (Pressure Biofeedback Unit = PBU) (Six weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of Stabilizing Exercises and Effect on Anticipatory Muscle Control in Patients With Subacute and Chronic Low Back Pain
Brief Summary: Muscular stability is essential to the spinal column to avoid harmful strain and injury to its structures. Sudden postural disturbances impose reactive internal forces through the spine. If the muscles do not react before the internal reactive forces propagate through the spine, there is a short fraction of time where the spinal column may lack sufficient muscular support. Studies have shown that in patients with low back pain deep abdominal and back muscle have a delayed response to reactive forces. The purpose of this study is to verify these findings and to investigate whether tailored interventions can improve the reaction time in stabilizing muscle around the lower spinal column i patients with subacute and chronic low back pain.


Options:
A: Muscle activity onset in transversus abdominal muscle (1 year)
B: Pain VAS
C: Pain (Visual Analog Scale) at baseline, weeks 4,12,26,52
D: Pain (6 weeks); Functional Disability (6 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of Stabilizing Exercises and Effect on Anticipatory Muscle Control in Patients With Subacute and Chronic Low Back Pain
Brief Summary: Muscular stability is essential to the spinal column to avoid harmful strain and injury to its structures. Sudden postural disturbances impose reactive internal forces through the spine. If the muscles do not react before the internal reactive forces propagate through the spine, there is a short fraction of time where the spinal column may lack sufficient muscular support. Studies have shown that in patients with low back pain deep abdominal and back muscle have a delayed response to reactive forces. The purpose of this study is to verify these findings and to investigate whether tailored interventions can improve the reaction time in stabilizing muscle around the lower spinal column i patients with subacute and chronic low back pain.


Options:
A: Pain Intensity (2 months after randomisation); Disability (2 months after randomisation)
B: Episodes of low back pain (2 years); Duration of low back pain (2 years); Severity of low back pain (2 years)
C: Pain VAS
D: Muscle activity onset in transversus abdominal muscle (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of the Effects of Titrated Oral Tolvaptan Tablets in Patients With Hyponatremia, Study 2
Brief Summary: This study's purpose is to determine whether tolvaptan can safely and effectively return the body's balance of sodium and water toward normal, and to characterize and quantify the potential clinical benefits of this treatment.


Options:
A: Dyspnea Improvement Measured by Likert Scale at 8 and 24 Hours (8 and 24 hours)
B: Number and time of recurrences of therapeutic paracenteses (up to 12 weeks)
C: The average daily area under the curve of change from baseline in serum sodium level up to Day 4 within the double-blind on therapy period.; and/or; The average daily area under the curve of change from baseline in serum sodium level up to Day 30 within the double-blind on therapy period.
D: The average daily area under the curve of change from baseline in serum sodium level up to Day 4 within the double-blind on therapy period. and/or; The average daily area under the curve of change from baseline in serum sodium level up to Day 30 within

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating the Effectiveness of Protocol Directed Sedation Management With Non-Protocol Directed Sedation Management on Mechanically Ventilated Patients in an Australian Intensive Care Unit.
Brief Summary: Sedation is an important treatment when caring for the critically ill patient on a respirator. Adequate sedation has been found to reduce stress, promote relaxation, induce amnesia, improve the tolerance of the respirator, and generally assist nursing care. However all sedation produces side effects for the patients. The aim of this study is to measure the effectiveness of two approaches to sedation management in an Australian Intensive Care unit.


Options:
A: Length of weaning from mechanical ventilation that corresponds to the time from Time 0 to the first extubation. (first extubation or 28 days)
B: achieving target sedation level (Patients will receive study drug for a maximum of 120 hours (5 days))
C: Duration of Ventilation
D: time to successful extubation (This will be the length of time that the patient remains on continuous infusions of sedation and/or analgesia in the ICU. At 60 days, all study interventions will terminate, but patients will be followed for outcomes.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating the Effectiveness of Protocol Directed Sedation Management With Non-Protocol Directed Sedation Management on Mechanically Ventilated Patients in an Australian Intensive Care Unit.
Brief Summary: Sedation is an important treatment when caring for the critically ill patient on a respirator. Adequate sedation has been found to reduce stress, promote relaxation, induce amnesia, improve the tolerance of the respirator, and generally assist nursing care. However all sedation produces side effects for the patients. The aim of this study is to measure the effectiveness of two approaches to sedation management in an Australian Intensive Care unit.


Options:
A: time to successful extubation (This will be the length of time that the patient remains on continuous infusions of sedation and/or analgesia in the ICU. At 60 days, all study interventions will terminate, but patients will be followed for outcomes.)
B: Ventilator free days
C: Duration of Ventilation
D: Duration of Mechanical Ventilation; ICU and Hospital Lengths of stay

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Usefulness of Nasal CPAP Treatment in Patients With a First Ever Stroke and Sleep Apnea Syndrome
Brief Summary: MAIN AIMS: to analyze the efficacy of nasal CPAP treatment in patients with ischemic first-ever stroke and Sleep Apnea Syndrome (SAS) in terms of: early neurological outcome, functional recovery, quality of life influence, stroke recurrence and survival.

SECONDARY AIMS: to evaluate the feasibility of the treatment in this type of patients at short and long time.

DESIGN: clinical randomized case-control study.

PATIENTS: younger than 75 years with a First-Ever stroke with at least one of the following criteria: snoring, observed apnea, Hypertension or Ischemic Cardiopathy.

MEASUREMENTS: protocol to define subtype stroke and parenchymatous and vascular location; sleep questionnaire (including Epworth Sleepiness Scale); Respiratory Polysomnography (RPSG). If RPSG shows an AHI \> 20, with predominant obstructive events, patients will be randomized in a CONTROL GROUP (conventional treatment) and a TREATMENT GROUP (with Nasal CPAP). Follow up for both groups at 1, 3, 12 and 24 months will include: early neurological outcome, body mass index (BMI), blood pressure (BP), functional recovery (Barthel Index/Canadian Scale), quality of life (SF36), recurrences, vital status. Nasal CPAP titration will be performed by means of an automatic system (Autoset Portable ST). Compliance will be recorded. If a negative RPSG is obtained (AHI \< 10) (NO SAS GROUP) or with AHI \< 20 (mild SAS) the usual treatment and the same follow up protocol will be established.

STATISTICS: the sample size is initially calculated in 10 patients for each group, considering this is part of a multicenter study including 8 centers. If no differences are found, depending on the statistical power the investigators will consider including more patients. The different groups will be compared for the analyzed variables with the corresponding tests.


Options:
A: Efficacy in reducing the mean AHI (12 months)
B: N/A
C: Apnea-hypopnea Index (AHI), Defined as the Number of Apneas and Hypopneas Per Hour of Sleep (48 hours after delivery)
D: Neurologic recovering; Quality of life; Recurrences

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3 Study of Changing of Lifestyle by Persons in Risk of Type 2 Diabetes
Brief Summary: We know that changing lifestyle can prevent type 2 diabetes. The challenge is how to help people changing their lifestyle. We have people in 2 groups: half of them is meeting in grops of 10 persons (interventiongroup), the other ones are just visiting their doctor (controlgroup).


Options:
A: Weigtreduction; Increase in maximum oxygen uptake; Change in foodintake; Change in self-reported activity
B: Postpartum weight retention (no more than 1.5 years)
C: Diabetes Incidence (Baseline through end of follow-up (mean follow-up time = 3 years))
D: Cesarean Section (At delivery); Preeclampsia/Pregnancy Induced Hypertension (Delivery); Gestational Diabetes Mellitus (Delivery); Large for Gestational Age (Delivery); Neonatal Intensive Care Unit (Within 1 month postpartum); Gestational Weight Gain (Gestational week 35)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Placebo-Controlled, Double-Blinded, Randomized Clinical Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Korean Patients With Active Rheumatoid Arthritis Despite Methotrexate
Brief Summary: Prior to the first infusion, patients will be randomized into one of two groups (placebo or infliximab). All patients will continue to receive the same does of methotrexate (MTX) during the study as received prior to the study. The objective of the study is to evaluate the efficacy and safety result of infliximab with Korean patients in reducing clinical signs and symptoms of rheumatoid arthritis (RA) at 30 weeks following the onset of treatment and to review whether the result is comparable to the result of the ATTRACT trial.


Options:
A: EULAR individual response (12 months)
B: Number of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24 (Week 24); Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 52 (Baseline and Week 52)
C: Achievement of a clinical response (according to the ACR criteria) at the 30-week follow-up visit. (30-week follow-up visit.)
D: Number of Participants With American College of Rheumatology 20 Response at Week 24 (Week 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Placebo-Controlled, Double-Blinded, Randomized Clinical Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Korean Patients With Active Rheumatoid Arthritis Despite Methotrexate
Brief Summary: Prior to the first infusion, patients will be randomized into one of two groups (placebo or infliximab). All patients will continue to receive the same does of methotrexate (MTX) during the study as received prior to the study. The objective of the study is to evaluate the efficacy and safety result of infliximab with Korean patients in reducing clinical signs and symptoms of rheumatoid arthritis (RA) at 30 weeks following the onset of treatment and to review whether the result is comparable to the result of the ATTRACT trial.


Options:
A: MRI synovitis, bone edema and erosions score (baseline, week 18 and 52)
B: Achievement of a clinical response (according to the ACR criteria) at the 30-week follow-up visit. (30-week follow-up visit.)
C: Number of Participants Meeting the American College of Rheumatology 20 (ACR 20) Response at Week 16 (Week 16)
D: Double-blind Period: Mean Synovitis Scores at Baseline As Measured by the Rheumatoid Arthritis Clinical Trials 6 (OMERACT 6) Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) (At baseline); Double-blind Period: Mean Change From Baseline in OMERACT 6 Wrist Synovitis Score: Planned Analysis Using Non-Parametric ANCOVA (Baseline to Day 113); Double-blind Period: Mean Change From Baseline in OMERACT 6 Wrist Synovitis Score: Post Hoc Sensitivity Analysis Using Parametric ANCOVA Analysis (Baseline to Day 113)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Placebo-Controlled, Double-Blinded, Randomized Clinical Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Korean Patients With Active Rheumatoid Arthritis Despite Methotrexate
Brief Summary: Prior to the first infusion, patients will be randomized into one of two groups (placebo or infliximab). All patients will continue to receive the same does of methotrexate (MTX) during the study as received prior to the study. The objective of the study is to evaluate the efficacy and safety result of infliximab with Korean patients in reducing clinical signs and symptoms of rheumatoid arthritis (RA) at 30 weeks following the onset of treatment and to review whether the result is comparable to the result of the ATTRACT trial.


Options:
A: Achievement of a clinical response (according to the ACR criteria) at the 30-week follow-up visit. (30-week follow-up visit.)
B: Percentage of Participants Achieving 28 Joint Disease Activity Score (DAS28) Less Than or Equal to (≤) 3.2 at Week 88 (Week 88)
C: Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response at Week 24 (Week 24)
D: American College of Rheumatology 20% (ACR20) Response at Week 12 (Baseline, Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Placebo-Controlled, Double-Blinded, Randomized Clinical Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Korean Patients With Active Rheumatoid Arthritis Despite Methotrexate
Brief Summary: Prior to the first infusion, patients will be randomized into one of two groups (placebo or infliximab). All patients will continue to receive the same does of methotrexate (MTX) during the study as received prior to the study. The objective of the study is to evaluate the efficacy and safety result of infliximab with Korean patients in reducing clinical signs and symptoms of rheumatoid arthritis (RA) at 30 weeks following the onset of treatment and to review whether the result is comparable to the result of the ATTRACT trial.


Options:
A: Double-blind Period: Mean Synovitis Scores at Baseline As Measured by the Rheumatoid Arthritis Clinical Trials 6 (OMERACT 6) Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) (At baseline); Double-blind Period: Mean Change From Baseline in OMERACT 6 Wrist Synovitis Score: Planned Analysis Using Non-Parametric ANCOVA (Baseline to Day 113); Double-blind Period: Mean Change From Baseline in OMERACT 6 Wrist Synovitis Score: Post Hoc Sensitivity Analysis Using Parametric ANCOVA Analysis (Baseline to Day 113)
B: Change From Baseline in Modified Total Sharp Score (mTSS) From Screening at Week 52 (Baseline and week 52)
C: Achievement of a clinical response (according to the ACR criteria) at the 30-week follow-up visit. (30-week follow-up visit.)
D: American College of Rheumatology (ACR) 20 Response at Week 14. (Week 14)

Answer: C