TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Pitavastatin Evaluation of Atherosclerosis Regression by Intensive Cholesterol-Lowering Therapy
Brief Summary: This study is aimed to analyze the effects of aggressive and conventional lipid lowering therapy with Pravastatin on carotid intima-media thickness (IMT) in patients with hyperlipidemia and abnormal thickening of IMT.


Options:
A: absolute changes in carotid intima-media thickness from baseline to final visit (12 months)
B: Assess the effects of rosuvastatin treatment on the change in the mean maximum intima media thickness (IMT) of the 12 vessel segments: the near & far walls of the CCA, the carotid bulb & the ICA
C: Anti-factor Xa plasma levels (within 3 days after surgery)
D: Change in intima media thickness as measured by carotid ultrasound

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pitavastatin Evaluation of Atherosclerosis Regression by Intensive Cholesterol-Lowering Therapy
Brief Summary: This study is aimed to analyze the effects of aggressive and conventional lipid lowering therapy with Pravastatin on carotid intima-media thickness (IMT) in patients with hyperlipidemia and abnormal thickening of IMT.


Options:
A: absolute changes in carotid intima-media thickness from baseline to final visit (12 months)
B: Death (through study completion, an average of 1 month)
C: D-dimer level (7 days post randomization); Seven-category ordinal scale recommended by the WHO (7 days post randomization)
D: Mortality (30 Days post intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Does EPA or DHA Prevent Depressive Symptoms in Pregnancy and Postpartum?
Brief Summary: This study is designed to test whether an alternative medicine treatment, fish oil, will prevent depressive symptoms in pregnant and postpartum women who have been found to be at risk for depression. Epidemiologists have observed that people who live in countries where people on average eat a diet high in fish have a lower risk of depression than people who live in populations that eat less fish. Postpartum depression is also less common in these countries. The omega-3 fatty acids found in fish oil are thought to be responsible for this beneficial effect of eating fish. The two major omega-3 fatty acids found in fish are eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). DHA is an essential building block of the brain and nerve tissue. EPA may act to optimize the electrical signals between nerve cells and brain cells and may help the immune system to function well.

Some researchers have treated people who are already suffering from depression with fish oil. Some of these studies have shown a benefit for the fish oil treatment and others have not. These studies have tested EPA and DHA alone and in various combinations. Currently, it is not known whether EPA or DHA is more effective in preventing and treating depression. Some of the researchers involved in this study have learned how to identify mothers who are most at risk for developing depression during and after pregnancy. This study is designed to learn whether EPA-rich and DHA-rich fish oil supplements will prevent depressive symptoms in women who are at risk to develop depression.


Options:
A: Beck Depression Inventory (6 - 8 weeks postpartum)
B: Gestational Diabetes Mellitus (GDM) (24-28 weeks of gestation); Macrosomia (At birth); Prevalence of insulin resistance (At birth)
C: Persistent wheeze 0 to 3 years of age (3 years)
D: percentage contribution of docosahexaenoic acid (DHA) to total phospholipid fatty acids in cord blood (labour)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Does EPA or DHA Prevent Depressive Symptoms in Pregnancy and Postpartum?
Brief Summary: This study is designed to test whether an alternative medicine treatment, fish oil, will prevent depressive symptoms in pregnant and postpartum women who have been found to be at risk for depression. Epidemiologists have observed that people who live in countries where people on average eat a diet high in fish have a lower risk of depression than people who live in populations that eat less fish. Postpartum depression is also less common in these countries. The omega-3 fatty acids found in fish oil are thought to be responsible for this beneficial effect of eating fish. The two major omega-3 fatty acids found in fish are eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). DHA is an essential building block of the brain and nerve tissue. EPA may act to optimize the electrical signals between nerve cells and brain cells and may help the immune system to function well.

Some researchers have treated people who are already suffering from depression with fish oil. Some of these studies have shown a benefit for the fish oil treatment and others have not. These studies have tested EPA and DHA alone and in various combinations. Currently, it is not known whether EPA or DHA is more effective in preventing and treating depression. Some of the researchers involved in this study have learned how to identify mothers who are most at risk for developing depression during and after pregnancy. This study is designed to learn whether EPA-rich and DHA-rich fish oil supplements will prevent depressive symptoms in women who are at risk to develop depression.


Options:
A: Depression severity and response status after 8 weeks of treatment
B: Change in depression ratings (HAMD, SIGH-ADS) (5 weeks)
C: 17-item Hamilton Depression Rating Scale (8 weeks)
D: Beck Depression Inventory (6 - 8 weeks postpartum)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Entry Into Comprehensive Methadone Treatment Via Interim Maintenance
Brief Summary: The purpose of the study is to determine whether one of three levels of counseling intensity will be associated with better treatment outcomes when combined with methadone maintenance treatment for heroin-addicted adults drawn from a methadone treatment program waiting list.


Options:
A: Three consecutive weeks of negative urine tests (benzoyl ecgonine) for cocaine use (no slips allowed). (These must be the last three weeks (7,8,9) of the trial.)
B: Percentage of Those Maintain or Improve to HIV RNA-1 Viral Load Less Then 400 Copies/mL (Baseline to month 6 post release)
C: Opioid positive drug tests (4 and 12 months post-baseline)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysine For Inhalation in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa (AIR-CF4)
Brief Summary: The purpose of this study was to evaluate the safety and efficacy of a 28-day course of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF), mild lung disease (forced expiratory volume in 1 second \[FEV1\] \>75% predicted, and Pseudomonas aeruginosa (PA) infection.


Options:
A: Change From Baseline in Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score at Day 28 (Day 0 to Day 28)
B: Change in P. Aeruginosa Density (from baseline to end of treatment (28 days))
C: Rate of Protocol-defined Exacerbations (PDE) From Baseline Through Week 24 (Baseline in the comparative phase to the end of study (average time on study during the Comparative Phase: 155.4 days))
D: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (From start of study until end of the study (up to 168 days)); Relative Change From Baseline in Percent Predicted Forced Expiratory Volume in One Second (FEV1) (Baseline, day 28)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysine For Inhalation in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa (AIR-CF4)
Brief Summary: The purpose of this study was to evaluate the safety and efficacy of a 28-day course of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF), mild lung disease (forced expiratory volume in 1 second \[FEV1\] \>75% predicted, and Pseudomonas aeruginosa (PA) infection.


Options:
A: To better define risk factors for first isolation of Pa from respiratory culture, as well as for emergence of mucoid Pa and antibiotic-resistant Pa. (over the two-to-five-year observational period); To better define clinical outcomes associated with acquisition of Pa, as well as outcomes associated with emergence of mucoid Pa and antibiotic-resistant Pa. (over the two-to-five-year observational period)
B: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (From start of study until end of the study (up to 168 days)); Relative Change From Baseline in Percent Predicted Forced Expiratory Volume in One Second (FEV1) (Baseline, day 28)
C: Pulmonary Function Test: Forced Expiratory Volume in 1 Second (FEV1) (Baseline to168 days)
D: Change From Baseline in Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score at Day 28 (Day 0 to Day 28)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysine For Inhalation in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa (AIR-CF4)
Brief Summary: The purpose of this study was to evaluate the safety and efficacy of a 28-day course of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF), mild lung disease (forced expiratory volume in 1 second \[FEV1\] \>75% predicted, and Pseudomonas aeruginosa (PA) infection.


Options:
A: Change From Baseline in Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score at Day 28 (Day 0 to Day 28)
B: Number of Participants With a Pulmonary Exacerbation Requiring IV Antibiotics or Hospitalization (Measured over the 18 month study)
C: Time to Recurrence of Pseudomonas (P.) Aeruginosa (Any Genotype) in Sputum or Deep Throat Cough Swab (From 1 month after the end of treatment (Day 56 for the 28-day treatment group and Month 3 for the 56-day treatment group) until the end of the study (Month 27))
D: Clinically Significant Laboratory Abnormalities. (28 Days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysine For Inhalation in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa (AIR-CF4)
Brief Summary: The purpose of this study was to evaluate the safety and efficacy of a 28-day course of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF), mild lung disease (forced expiratory volume in 1 second \[FEV1\] \>75% predicted, and Pseudomonas aeruginosa (PA) infection.


Options:
A: Number of Participants With Treatment-Emergent Adverse Events (56 days)
B: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
C: Change From Baseline in Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score at Day 28 (Day 0 to Day 28)
D: to assess safety profile in terms of incidence of adverse events/adverse drug reactions, frequency of cystic fibrosis exacerbations, audiometric test, laboratory parameters (hematology and blood chemistry), vitals signs (hr and bp), physical examination. (up to 48 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysine For Inhalation in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa (AIR-CF4)
Brief Summary: The purpose of this study was to evaluate the safety and efficacy of a 28-day course of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF), mild lung disease (forced expiratory volume in 1 second \[FEV1\] \>75% predicted, and Pseudomonas aeruginosa (PA) infection.


Options:
A: Change From Baseline to End of the Treatment Period of Forced Expiratory Volume in 1 Second (FEV1), Expressed as Percentage of Predicted Normal (Day 0 (baseline), Week 4)
B: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (From start of study until end of the study (up to 168 days)); Relative Change From Baseline in Percent Predicted Forced Expiratory Volume in One Second (FEV1) (Baseline, day 28)
C: Change From Baseline in Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score at Day 28 (Day 0 to Day 28)
D: to assess safety profile in terms of incidence of adverse events/adverse drug reactions, frequency of cystic fibrosis exacerbations, audiometric test, laboratory parameters (hematology and blood chemistry), vitals signs (hr and bp), physical examination. (up to 48 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysine For Inhalation in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa (AIR-CF4)
Brief Summary: The purpose of this study was to evaluate the safety and efficacy of a 28-day course of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF), mild lung disease (forced expiratory volume in 1 second \[FEV1\] \>75% predicted, and Pseudomonas aeruginosa (PA) infection.


Options:
A: Number of Participants With a Pulmonary Exacerbation Requiring IV Antibiotics or Hospitalization (Measured over the 18 month study)
B: Relative Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted at Day 28 (Baseline and end of treatment Course 1 (Day 28)); Mean Actual Change From Baseline in FEV1 Percent Predicted Across 3 Treatment Courses (Baseline, and end of treatment Courses 1 (Week 4), 2 (Week 12), and 3 (Week 20))
C: Change From Baseline in Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score at Day 28 (Day 0 to Day 28)
D: Time to Recurrence of Pseudomonas (P.) Aeruginosa (Any Genotype) in Sputum or Deep Throat Cough Swab (From 1 month after the end of treatment (Day 56 for the 28-day treatment group and Month 3 for the 56-day treatment group) until the end of the study (Month 27))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Multicentre Trial for Lymphadenectomy In Ovarian Neoplasms
Brief Summary: To assess the efficacy of systematic pelvic and para-aortic lymphadenectomy in patients with advanced ovarian cancer and intra-abdominal complete debulking.

Secondary: progression-free survival, complications and quality of life; Exploratory: Role of number of resected lymph nodes for primary and secondary objectives


Options:
A: Disease free survival (5 years from surgery)
B: Overall Survival (time from randomization until death)
C: Stage 1: Return to usual activities (12 months from surgery); Stage 2: Disease Free Survival (4.5 years from surgery)
D: Estimate the Sensitivity of the Sentinel Lymph Node (3 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Multicentre Trial for Lymphadenectomy In Ovarian Neoplasms
Brief Summary: To assess the efficacy of systematic pelvic and para-aortic lymphadenectomy in patients with advanced ovarian cancer and intra-abdominal complete debulking.

Secondary: progression-free survival, complications and quality of life; Exploratory: Role of number of resected lymph nodes for primary and secondary objectives


Options:
A: proportion of clinical complete remission
B: Overall Survival (time from randomization until death)
C: Evaluation and comparison of early surgical complications of primary surgery and Interval debulking surgery. (thirty days); Evaluation and comparison of late surgical complications of primary surgery and Interval debulking surgery (six months); Evaluation of the progression free survival (PFS) (Thirty-six months)
D: overall survival (OS) (Patients will be followed up for a minimum of 5 years after registration/randomisation or until death)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Gabapentin Extended Release (G-ER) Tablets in the Treatment of Patients With Painful Diabetic Peripheral Neuropathy
Brief Summary: The purpose of this study is to determine whether a new Gabapentin tablet, is safe and effective for the treatment of painful diabetic peripheral neuropathy.


Options:
A: Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at End of Maintenance Treatment (EOMT) Using Last Observation Carried Forward (LOCF) Data (Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit))
B: Change in pain and symptoms (Up to 14 weeks)
C: The primary study objective is to assess the relative efficacy of G-ER versus placebo in reducing the mean daily pain score from the baseline week to end of efficacy treatment period (Treatment Week 4) in patients with DPN. (4 weeks)
D: Change From Baseline to End of Study in LOCF VAS (8 weeks (Baseline and Week 8))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Gabapentin Extended Release (G-ER) Tablets in the Treatment of Patients With Painful Diabetic Peripheral Neuropathy
Brief Summary: The purpose of this study is to determine whether a new Gabapentin tablet, is safe and effective for the treatment of painful diabetic peripheral neuropathy.


Options:
A: Changes in a Pain Rating Scale After 3 Weeks of Blinded Treatment. (Baseline and Post-randomization Day 22); Number of Participants With Treatment-emergent Adverse Events (Randomization to Post-randomization Day 29 (includes dose reduction))
B: The primary study objective is to assess the relative efficacy of G-ER versus placebo in reducing the mean daily pain score from the baseline week to end of efficacy treatment period (Treatment Week 4) in patients with DPN. (4 weeks)
C: The primary study objective is to assess the relative efficacy of G-ER versus placebo in reducing the average daily pain score from the baseline week to the final week of the efficacy treatment period (Treatment Week 10) in patients with PHN; Daily pain scores will be measured using an electronic diary.
D: Alteration of pain intensity after treatment (5 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: ITAREPS Trial: A Prospective Randomized Double-blind Controlled Study in IT-aided Mobile Phone-based Relapse Prevention Program in Schizophrenia.
Brief Summary: Information Technology-aided Program of Relapse Prevention in Schizophrenia (ITAREPS) will decrease the number of hospitalizations in patients with schizophrenia or schizoaffective disorder who are treated in the outpatient psychiatric setting, as evidenced by the reduction of the total number of hospitalizations due to relapse of psychosis at the end of the 12-months follow-up period in the active ITAREPS group compared to the control (treatment-as-usual) group.


Options:
A: The reduction of the number of hospitalizations for psychotic relapses in patients diagnosed with schizophrenia and schizoaffective disorder (November 2008-November 2009)
B: to determine the impact of a site-independent, remote, telemedicine consultation system on decision making in the Emergency Department, regarding the decision to treat or not to treat with thrombolytics (90 days); to assess the numbers of patients who receive thrombolytics and the time to treatment in patients evaluated by telemedicine versus telephone only (90 days); to assess the appropriateness of thrombolytic treatment decisions in telemedicine versus telephone-only consultations (90 days); to assess the completeness of the data collection in telemedicine versus telephone-only consultations. (90 days)
C: Time Per Patient From a Clinical Event to a Clinical Decision in Response to Arrhythmias, Cardiovascular (CV) Disease Progression, and Device Issues (Enrollment to last visit (up to 15 month post-implant))
D: hemoglobin A1c (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: ITAREPS Trial: A Prospective Randomized Double-blind Controlled Study in IT-aided Mobile Phone-based Relapse Prevention Program in Schizophrenia.
Brief Summary: Information Technology-aided Program of Relapse Prevention in Schizophrenia (ITAREPS) will decrease the number of hospitalizations in patients with schizophrenia or schizoaffective disorder who are treated in the outpatient psychiatric setting, as evidenced by the reduction of the total number of hospitalizations due to relapse of psychosis at the end of the 12-months follow-up period in the active ITAREPS group compared to the control (treatment-as-usual) group.


Options:
A: rate of patients with therapeutic INR levels on day six without anticoagulation-related complications during the loading period (after 30 days)
B: The 2 different doses used are non-inferior to each other
C: The Percent of Out of Range (OOR) International Normalized Prothrombin Time Ratio (INRs) in the Standard and Modified Pharmacogenetic Arms. (1 month (from day 3 to day 30)); The Percent of Out of Range (OOR) INRs in Pharmacogenetic-guided Patients and Parallel Controls (1 month (from day 3 to day 30)); The Percent of Time in Therapeutic Range (TTR) for the Standard and Modified Pharmacogenetic Algorithms. (1 month (from baseline to day 30)); The Time in Therapeutic Range (TTR) for the Pharmacogenetic-guided Patients and Parallel Controls (1 month (from baseline to day 30))
D: The reduction of the number of hospitalizations for psychotic relapses in patients diagnosed with schizophrenia and schizoaffective disorder (November 2008-November 2009)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double Blind, Placebo Controlled, Phase IIb Dose Ranging Study (With Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate.
Brief Summary: This study is being carried out to investigate if AZD5672 is effective in treating Rheumatoid Arthritis (RA) and if so how it compares to placebo (a substance which does not have any action) and etanercept (a medicine already available to treat Rheumatoid Arthritis) when added to treatment with methotrexate. The purpose of this study is also to find out which dose of AZD5672 is the most effective at treating RA and to find out how well the body tolerates AZD5672 when taken for up to 12 weeks.


Options:
A: The objective of this study is to evaluate the therapeutic response including radiographic changes and safety of etanercept alone, methotrexate (MTX) alone, and the combination of etanercept and MTX in patients with rheumatoid arthritis (RA)
B: Proportion of subjects achieving a good or moderate DAS28 response (as defined by the EULAR28 response criteria) at Week 12
C: American College of Rheumatology 20 Response (ACR20) (12 weeks)
D: The Number of Participants Achieving Remission As Measured by a Disease Activity Score for 28 Joints (DAS 28) < 2.6. (12 months); Year 1 Participants Having an Annualized Modified Total Sharp Score (mTSS) < 0.5. (12 months)

Answer: C