TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Omega-3 for Depression and Other Cardiac Risk Factors
Brief Summary: This study will determine the effects of omega-3 fatty acid (FA) augmentation of sertraline on depression and cardiac endpoints after myocardial infarction (MI).


Options:
A: Beck Depression Inventory-II (Measured at Baseline and 10 weeks)
B: Change in depressive symptoms as a result of intervention effects (Baseline, 3, 6 and 12 months); Change in intervention effects on depressive symptoms moderated by perceived stigma (Baseline, 3, 6, and 12 months); Change in intervention effects on depressive symptoms moderated by sex (Baseline, 3, 6, and 12 months)
C: Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c (Baseline to 12 months); Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); Systolic Blood Pressure at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); LDL Cholesterol at Baseline and 12 Months (Measured at Baseline and 12 months); Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 months and 12 months)
D: Recruitment Feasibility: Percent of Participants Screened Eligible (6 months); Recruitment Feasibility: Percent of Participants Enrolled (6 months); MBCT Feasibility: Percent of Participants Retained (6 months); Mindfulness Based Cognitive Therapy (MBCT) Feasibility: Percent of Participants Adherent to Treatment (6 months); Mindfulness Based Cognitive Therapy (MBCT) Feasibility: Percent of Participants Adherent to Home Practice (6 months); Control Group Feasibility: Percent of Participants Retained (6 months); Control Group Feasibility: Percent of Participants Adherent to Treatment (6 months); Control Group Feasibility: Percent of Participants Adherent to Home Practice (6 months); Videoconferencing Feasibility: Number of Sessions Missed Due to Technical Problems (6 months); Blood Spot Feasibility: Percent of Blood Spot Samples Submitted at Baseline (At Baseline (Month 0)); Blood Spot Feasibility: Percent of Blood Spot Samples Submitted at Post-intervention (At Post Intervention (Month 3)); Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Ratings of Intervention Satisfaction (At post intervention (Month 3)); Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Percent of Participants Who Plan to Continue Using the Skills (6 months); Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Percent of Participants Who Would Recommend the Program (6 months); Control Group Acceptability: Ratings of Intervention Satisfaction (6 months); Control Group Acceptability: Percent of Participants Who Plan to Continue Using the Skills (6 months); Control Group Acceptability: Percent of Participants Who Would Recommend the Program (6 months); Videoconferencing Acceptability: Ratings of Videoconferencing Satisfaction (6 months); Blood Spot Acceptability: Blood Spot Collection Ease (6 months); Blood Spot Acceptability: Blood Spot Collection Comfort (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Omega-3 for Depression and Other Cardiac Risk Factors
Brief Summary: This study will determine the effects of omega-3 fatty acid (FA) augmentation of sertraline on depression and cardiac endpoints after myocardial infarction (MI).


Options:
A: N/A
B: Endpoint Hamilton Depression Rating Scale (HAMD) Scores Adjusted for Age, Sex, Treatment Site, and Baseline HAMD Scores. (Week 12); Endpoint Red Blood Cell/Plasma EPA Values Adjusted for Age, Sex, Treatment Site, and Baseline Red Blood Cell/Plasma EPA Values. (Week 12)
C: Beck Depression Inventory-II (Measured at Baseline and 10 weeks)
D: Hamilton Depression Rating Scale 17 (HDRS-17) Scores (Baseline, Weeks 1, 2, 4, 6, 8, 10 and 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Omega-3 for Depression and Other Cardiac Risk Factors
Brief Summary: This study will determine the effects of omega-3 fatty acid (FA) augmentation of sertraline on depression and cardiac endpoints after myocardial infarction (MI).


Options:
A: Hamilton Rating Scale for Depression (HAM-D-17) (12 weeks post-randomization)
B: Symptoms of depression (3 months)
C: Generic Mental Health-Related Quality of Life (Measured 8 months post-CABG)
D: Beck Depression Inventory-II (Measured at Baseline and 10 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Periodontal Infection and Prematurity Study
Brief Summary: This research project is a multi-center double-blind, parallel, randomized, controlled clinical trial design comparing the efficacy of dental scaling and root planing to control treatment (superficial cleaning) for the prevention of preterm birth in pregnant women with periodontal disease.


Options:
A: Rate of pre-term birth
B: Whether screening and treating periodontal disease using scaling and root planing early in pregnancy can reduce the incidence of spontaneous preterm birth <35 weeks (9 months)
C: Gestational age at birth (At delivery)
D: Birth at less than 37 weeks gestational age (37 weeks gestational age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Cross-Over Comparative Study of Inhaled Mannitol, Alone and in Combination With Daily rhDNase, in Children With Cystic Fibrosis
Brief Summary: The purpose of this study is to determine the medium term efficacy and safety profile of inhaled mannitol, on its own and also as an additional therapy to rhDNase (pulmozyme). In particular, we will assess the impact on: lung function; airway inflammation; sputum microbiology; exacerbations; quality of life; adverse events; exercise tolerance; total costs of hospital and community care; and cost-effectiveness.


Options:
A: Comparison of the judgement on global pleasure of the inhalation between the two treatment groups (The outcome measure was assessed at day 1, day 7, day 14, day 21, and day 28 of the four-weeks treatment period. For each time-point we operated a comparison between the two groups.); Comparison of the symptom cough between the two treatment groups (The outcome measure was assessed at day 1, day 7, day 14, day 21, and day 28 of the four-weeks treatment period. For each time-point we operated a comparison between the two groups.); Comparison of the sensation of saltiness between the two treatment groups (The outcome measure was assessed at day 1, day 7, day 14, day 21, and day 28 of the four-weeks treatment period. For each time-point we operated a comparison between the two groups.); Comparison of the sensation of throat irritation between the two treatment groups (The outcome measure was assessed at day 1, day 7, day 14, day 21, and day 28 of the four-weeks treatment period. For each time-point we operated a comparison between the two groups.)
B: Change in FEV1 Percentage Predicted From Baseline (14 days)
C: FEV1 after 12 weeks of each of the following treatment regimens: *mannitol only *rhDNase only *mannitol + rhDNase (12 weeks)
D: Number of Participants Eligible to be Assessed for Sub-study Enrollment (2-week run-in period)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Cross-Over Comparative Study of Inhaled Mannitol, Alone and in Combination With Daily rhDNase, in Children With Cystic Fibrosis
Brief Summary: The purpose of this study is to determine the medium term efficacy and safety profile of inhaled mannitol, on its own and also as an additional therapy to rhDNase (pulmozyme). In particular, we will assess the impact on: lung function; airway inflammation; sputum microbiology; exacerbations; quality of life; adverse events; exercise tolerance; total costs of hospital and community care; and cost-effectiveness.


Options:
A: Variations in the Sino-nasal-outcome test SNOT-20 adapt CF (primary nasal parameters: obstruction of nasal breathing, sneeze stimulus, permanent nose running, thick-mucous nasal discharge, earaches) (day 1, 29, 57 and 85)
B: FEV1
C: FEV1 after 12 weeks of each of the following treatment regimens: *mannitol only *rhDNase only *mannitol + rhDNase (12 weeks)
D: To determine the effects of 400 mg twice-daily administration of IDPM on FEV1 in patients with CF compared to control (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Cross-Over Comparative Study of Inhaled Mannitol, Alone and in Combination With Daily rhDNase, in Children With Cystic Fibrosis
Brief Summary: The purpose of this study is to determine the medium term efficacy and safety profile of inhaled mannitol, on its own and also as an additional therapy to rhDNase (pulmozyme). In particular, we will assess the impact on: lung function; airway inflammation; sputum microbiology; exacerbations; quality of life; adverse events; exercise tolerance; total costs of hospital and community care; and cost-effectiveness.


Options:
A: FEV1 after 12 weeks of each of the following treatment regimens: *mannitol only *rhDNase only *mannitol + rhDNase (12 weeks)
B: FEV1
C: Stability of Lung Function: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) (At the end of each 2-week treatment period); Safety: Number of Participants With Adverse Events During Each Treatment Period (4 Weeks)
D: To determine the effects of 400 mg twice-daily administration of IDPM on FEV1 in patients with CF compared to control (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Cross-Over Comparative Study of Inhaled Mannitol, Alone and in Combination With Daily rhDNase, in Children With Cystic Fibrosis
Brief Summary: The purpose of this study is to determine the medium term efficacy and safety profile of inhaled mannitol, on its own and also as an additional therapy to rhDNase (pulmozyme). In particular, we will assess the impact on: lung function; airway inflammation; sputum microbiology; exacerbations; quality of life; adverse events; exercise tolerance; total costs of hospital and community care; and cost-effectiveness.


Options:
A: FEV1 after 12 weeks of each of the following treatment regimens: *mannitol only *rhDNase only *mannitol + rhDNase (12 weeks)
B: To determine the effects of 400 mg twice-daily administration of IDPM on FEV1 in patients with CF compared to control (6 months)
C: FEV1
D: Change in Absolute FEV1 From Baseline Over 26 Weeks (26 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Cross-Over Comparative Study of Inhaled Mannitol, Alone and in Combination With Daily rhDNase, in Children With Cystic Fibrosis
Brief Summary: The purpose of this study is to determine the medium term efficacy and safety profile of inhaled mannitol, on its own and also as an additional therapy to rhDNase (pulmozyme). In particular, we will assess the impact on: lung function; airway inflammation; sputum microbiology; exacerbations; quality of life; adverse events; exercise tolerance; total costs of hospital and community care; and cost-effectiveness.


Options:
A: FEV1
B: FEV1 after 12 weeks of each of the following treatment regimens: *mannitol only *rhDNase only *mannitol + rhDNase (12 weeks)
C: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
D: To determine the effects of 400 mg twice-daily administration of IDPM on FEV1 in patients with CF compared to control (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Cross-Over Comparative Study of Inhaled Mannitol, Alone and in Combination With Daily rhDNase, in Children With Cystic Fibrosis
Brief Summary: The purpose of this study is to determine the medium term efficacy and safety profile of inhaled mannitol, on its own and also as an additional therapy to rhDNase (pulmozyme). In particular, we will assess the impact on: lung function; airway inflammation; sputum microbiology; exacerbations; quality of life; adverse events; exercise tolerance; total costs of hospital and community care; and cost-effectiveness.


Options:
A: Reduction in bacterial load (1 year)
B: Number of pulmonary exacerbations (One year)
C: 24 hour sputum clearance (24 hours / 12 weeks); Quality of Life SGRQ (12 weeks)
D: FEV1 after 12 weeks of each of the following treatment regimens: *mannitol only *rhDNase only *mannitol + rhDNase (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind Study Comparing the Clinical Effects of Intravenous Montelukast With Placebo in Pediatric Patients (Ages 6 to 14 Years) With Acute Asthma
Brief Summary: This study will attempt to find out if the addition of an intravenous form of a drug that is already used for treating asthma in children will help resolve asthma attacks faster than using the current standard care alone.


Options:
A: Improvement in FEV1 (Forced Expiratory Volume in 1 Second) Over the First 60 Minutes After Administration (Baseline and (time weighted average over) 60 Minutes)
B: FEV1
C: Airway responsiveness as a measure of salbutamol bronchoprotection (ten minutes post 200mcg salbutamol on day 1); Airway responsiveness as a measure of salbutamol bronchoprotection (ten minutes post 200mcg salbutamol on day 3); Airway responsiveness as a measure of bronchoprotection. The primary outcome is to determine the onset of this tolerance. (ten minutes post 200mcg salbutamol on day 5); Airway responsiveness as a measure of salbutamol bronchoprotection (ten minutes post 200mcg salbutamol on day 7)
D: Improvement in forced expiratory volume in 1 second [FEV1] within the first 60 minutes after administration (within the first 60 minutes after administration)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind Study Comparing the Clinical Effects of Intravenous Montelukast With Placebo in Pediatric Patients (Ages 6 to 14 Years) With Acute Asthma
Brief Summary: This study will attempt to find out if the addition of an intravenous form of a drug that is already used for treating asthma in children will help resolve asthma attacks faster than using the current standard care alone.


Options:
A: N/A
B: Improvement in forced expiratory volume in 1 second [FEV1] within the first 60 minutes after administration (within the first 60 minutes after administration)
C: Improvement in FEV1 (Forced Expiratory Volume in 1 Second) Over the First 60 Minutes After Administration (Baseline and (time weighted average over) 60 Minutes)
D: Reduction in modified pulmonary index score (MPIS) to less than 9 at the end of 4 hours. (4 hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind Study Comparing the Clinical Effects of Intravenous Montelukast With Placebo in Pediatric Patients (Ages 6 to 14 Years) With Acute Asthma
Brief Summary: This study will attempt to find out if the addition of an intravenous form of a drug that is already used for treating asthma in children will help resolve asthma attacks faster than using the current standard care alone.


Options:
A: N/A
B: Mean Change From Baseline at Endpoint in Morning Peak Expiration Flow (PEF) for Intent-to-Treat Population (Baseline to Endpoint (weeks 3-4)); Mean Change From Baseline at Endpoint in Morning Peak Expiratory Flow (PEF) for Per Protocol Population (Baseline to Endpoint (weeks 3-4))
C: Improvement in FEV1 (Forced Expiratory Volume in 1 Second) Over the First 60 Minutes After Administration (Baseline and (time weighted average over) 60 Minutes)
D: Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Participants (8 Week treatment period initiated at the beginning of a school year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Safety, Tolerability and Impact on Biomarkers of Anti-Oxidant Treatment of Mild to Moderate Alzheimer's Disease
Brief Summary: The purpose of this study is to examine the safety and effectiveness of two anti-oxidant treatment regimens in patients with mild to moderate Alzheimer's disease. The anti-oxidant treatments include vitamin E + C + alpha-lipoic acid, and Coenzyme Q (CoQ).


Options:
A: effect on cerebrospinal fluid (CSF) biomarkers related to oxidative damage (baseline and 4 months)
B: Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Mini-Mental State Examination Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Neuropsychiatric Inventory Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Caregiver Activity Survey Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline)
C: Major fatal and non fatal ischemic cardiovascular events; Cancer any kind except for basal cell skin carcinoma
D: Regression of white matter lesion load in terms of numbers and size in the brain (1 to 2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Safety, Tolerability and Impact on Biomarkers of Anti-Oxidant Treatment of Mild to Moderate Alzheimer's Disease
Brief Summary: The purpose of this study is to examine the safety and effectiveness of two anti-oxidant treatment regimens in patients with mild to moderate Alzheimer's disease. The anti-oxidant treatments include vitamin E + C + alpha-lipoic acid, and Coenzyme Q (CoQ).


Options:
A: Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Mini-Mental State Examination Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Neuropsychiatric Inventory Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Caregiver Activity Survey Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline)
B: Cognitive Measures (6 months)
C: cognitive improvement or maintenance of cognitive performance (within 3 months of treatment)
D: effect on cerebrospinal fluid (CSF) biomarkers related to oxidative damage (baseline and 4 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Anti-IgE Antibody Omalizumab (Xolair) on Patients With Chronic Sinusitis and a Positive Allergen Test
Brief Summary: The purpose of this study is to determine if treatment with the anti-IgE antibody, Xolair (omalizumab), will improve objective and subjective evidence of chronic sinusitis.


Options:
A: Mucosal thickness on CT scan (after 6 months of treatment)
B: Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: Intent-to-Treat (ITT) Population (Baseline to Week 52); Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12: ITT Population (Baseline, Week 12)
C: Change From Baseline in Bilateral Endoscopic Nasal Polyp Score (NPS) at Week 16 (Baseline, Week 16)
D: Frequency of Clinical Asthma Exacerbations (CAEs) During 12 Months of Treatment (Day 1 to Month 12); Frequency of Each of the Two Criteria for Clinical Asthma Exacerbations (CAEs) (Day 1 to Month 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Anti-IgE Antibody Omalizumab (Xolair) on Patients With Chronic Sinusitis and a Positive Allergen Test
Brief Summary: The purpose of this study is to determine if treatment with the anti-IgE antibody, Xolair (omalizumab), will improve objective and subjective evidence of chronic sinusitis.


Options:
A: Mucosal thickness on CT scan (after 6 months of treatment)
B: Change From Baseline at Week 24 in Nasal Congestion/Obstruction Symptom Severity Score (Baseline, Week 24); Change From Baseline at Week 24 in Nasal Polyp Score (Baseline, Week 24)
C: Change From Baseline in Bilateral Endoscopic Nasal Polyp Score (NPS) at Week 16 (Baseline, Week 16)
D: Frequency of Clinical Asthma Exacerbations (CAEs) During 12 Months of Treatment (Day 1 to Month 12); Frequency of Each of the Two Criteria for Clinical Asthma Exacerbations (CAEs) (Day 1 to Month 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Open-label, Multi-centre Phase II Study of BAY43-9006 (Sorafenib) Versus Standard Treatment With Interferon Alpha-2a in Patients With Unresectable and/or Metastatic Renal Cell Carcinoma.
Brief Summary: The purpose of the study is to:

* Find out if patients receiving BAY43-9006 will live longer without tumor progression than those receiving standard therapy with interferon alpha-2a
* Find out if a higher dose of BAY43-9006 can inhibit tumor progression in patients who progressed during standard dose treatment with BAY43-9006, and for how long these patients live without progression
* Find out how long patients live without progression who receive BAY43-9006 after failing to respond to standard therapy with interferon alpha-2a
* Find out in how many percent of patients BAY43-9006 prevents the growth of or shrinks kidney tumors and/or their metastases depending on treatment and dosage
* Find out if BAY43-9006 has any effect on the quality of life of patients with kidney cancer
* Find out the level of BAY43-9006 in the blood once per month and any changes in this level
* Find out whether BAY43-9006 effects are associated with specific biomarkers


Options:
A: Progression Free Survival (2 3/4 years)
B: Progression-Free Survival (PFS), Core Radiology Assessment (Day 28 of each 6-week cycle: duration of treatment phase); Progression-Free Survival (PFS), Investigator's Assessment (Day 28 of each 6-week cycle: duration of treatment phase)
C: Progression-free Survival (PFS) Based on Independent Radiological Review for the First Intervention Period (From randomization of the first subject until 15 months later, assessed every 8 weeks)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Dose-Selection Study of Ad2/Hypoxia Inducible Factor (HIF)-1α/VP16 in Patients With Intermittent Claudication
Brief Summary: The purpose of this Phase 2 clinical research study is to examine the safety of an experimental gene transfer agent, Ad2/HIF-1α/VP16, and its ability to stimulate the growth of new blood vessels from existing blood vessels (a process called angiogenesis) in an attempt to improve the flow of blood in the legs of patients with peripheral arterial disease (PAD).

Specifically, this study will enroll patients with severe intermittent claudication (IC) which is the stage of PAD in which a patient's walking ability is severely limited, causing pain in the legs upon exercise due to inadequate blood flow to the muscles of the lower limbs.


Options:
A: Primary efficacy parameter: ulcer healing.; Ulcers will be evaluated at each visit primarily by collecting quantitative and qualitative information.
B: Enhancement of vessel formation accessed by Nuclear Perfusion Scan in critical limb ischemia. (4 months)
C: Change from baseline in Absolute Claudication Distance (ACD) evaluated by treadmill test at week 13 (13 weeks)
D: Peak Walking Time (at 6 months)

Answer: D