TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of a Polyphenol Rich Diet on Vascular and Platelet Function- a Randomised Control Trial
Brief Summary: Previous work has shown that increasing fruit and vegetable intake in patients with high blood pressure improves cardiovascular function. Research indicates that this may be partly owing to compounds called polyphenols, which are found in abundance in fruits and vegetables and other foods such as wine, tea and dark chocolate. The investigators now wish to test if consuming fruits and vegetables (including berries which are very rich in polyphenols), as well as dark chocolate, has further benefits for cardiovascular function. A total of 110 subjects with high blood pressure will be recruited and asked to follow a low polyphenol diet (2 portions of fruit and vegetables daily and no berries or dark chocolate) for four weeks (a washout period). They will then be randomised to continue this diet or to consume 6 portions of fruits and vegetables (to include 1 portion berries) and 1 portion of dark chocolate daily for 8 weeks. The fruit, vegetables and dark chocolate will be provided free of charge and delivered to the homes of the participants who are randomised to the high fruit and vegetable arm of the study.

Assessment of microvascular and platelet function will be undertaken before and after consuming this diet. Improvements in these tests of cardiovascular function have previously been linked to reduced risks of heart disease in people with high blood pressure. This study will provide evidence as to whether or not a polyphenol rich diet can reduce the risk of developing heart disease.


Options:
A: Change in cardiovascular disease risk indictaors - including carotid intima-media thickness (CIMT), total plaque volume (TPV) (at the carotid bifurcation), pulse wave velocity (PWV) and biomarkers of risk in blood samples . (6 months - 1 year)
B: Augmentation index (Changes in augmentation index at 1 week, according to glycemic index of the breakfast)
C: Vascular function (Measured at weeks 4 and 12)
D: Endothelial function (Time points: day 0 [baseline], and day 30 each 0 and 2h.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Effect of the Association of Noninvasive Ventilation and High Flow Nasal Oxygen Therapy in Resuscitation of Patients With Acute Lung Injury. A Randomised Study (FLORALI Study)
Brief Summary: The aim of the study is to compare, in patients with acute respiratory failure/acute lung injury the efficacy of three different methods of oxygenation to prevent endotracheal intubation :

1. conventional oxygen therapy (O2 conventional)
2. high flow nasal oxygen therapy (O2-HFN)
3. association of high flow nasal oxygen therapy with non invasive positive pressure ventilation (O2-HFN/NPPV).


Options:
A: Oxygenation (PaO2/FiO2 ratio) (Up to 48 hours after extubation)
B: To compare the number of patients in each group who require endotracheal intubation with mechanical ventilation (at day 28)
C: The decrease of diaphragmatic workload (thickening fraction of the diaphragm) (30 minutes)
D: mortality rates (day 28)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Effect of the Association of Noninvasive Ventilation and High Flow Nasal Oxygen Therapy in Resuscitation of Patients With Acute Lung Injury. A Randomised Study (FLORALI Study)
Brief Summary: The aim of the study is to compare, in patients with acute respiratory failure/acute lung injury the efficacy of three different methods of oxygenation to prevent endotracheal intubation :

1. conventional oxygen therapy (O2 conventional)
2. high flow nasal oxygen therapy (O2-HFN)
3. association of high flow nasal oxygen therapy with non invasive positive pressure ventilation (O2-HFN/NPPV).


Options:
A: Post-extubation respiratory failure and Reintubation rate (3 months)
B: Respiratory failure after extubation (72 hours)
C: To compare the number of patients in each group who require endotracheal intubation with mechanical ventilation (at day 28)
D: Tidal variation (Twenty minutes after each oxygen therapy. (At the end of each oxygen therapy))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Clinical Trial of a Vitamin/Nutriceutical Formulation for Alzheimer's Disease
Brief Summary: Based on prior published pilot studies, the investigators have initiated a larger, multi-site placebo-controlled clinical trial with Alzheimer's disease (AD) patients and individuals diagnosed with Mild Cognitive Impairment (MCI), with the hopes of (1) confirming (or denying) the above promising clinical findings, and (2) determining whether or not our formulation can delay MCI "conversion" to AD.


Options:
A: effect on cerebrospinal fluid (CSF) biomarkers related to oxidative damage (baseline and 4 months)
B: cognitive improvement or maintenance of cognitive performance (within 3 months of treatment)
C: Frequency of adverse events (baseline, monthly for 1 year, then 15 and 18 months)
D: Number of Participants With Prostate Cancer (Every six months for 7 to 12 years depending on when the participant was randomized.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Clinical Trial of a Vitamin/Nutriceutical Formulation for Alzheimer's Disease
Brief Summary: Based on prior published pilot studies, the investigators have initiated a larger, multi-site placebo-controlled clinical trial with Alzheimer's disease (AD) patients and individuals diagnosed with Mild Cognitive Impairment (MCI), with the hopes of (1) confirming (or denying) the above promising clinical findings, and (2) determining whether or not our formulation can delay MCI "conversion" to AD.


Options:
A: The goal is to determine the effects of the vitamin C and vitamin E on surrogate markers of atherosclerosis following an atherogenic meal in type 2 diabetes (2 months)
B: Prostate cancer (Ongoing); Total cancer (Ongoing); Major cardiovascular events (Ongoing)
C: Regression of white matter lesion load in terms of numbers and size in the brain (1 to 2 years)
D: cognitive improvement or maintenance of cognitive performance (within 3 months of treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: CBT for Social Anxiety Disorder Delivered by School Counselors
Brief Summary: This 5-year study addresses the unmet needs of adolescents with social phobia through the testing of a 12-week cognitive-behavioral, school-based group intervention delivered by trained school counselors compared to a nonspecific school counseling program. A secondary goal is to provide further examination of the efficacy of the CBT program delivered by school counselors as compared to the same program delivered by psychologists.


Options:
A: Pediatric Anxiety Rating Scale. (Post-treatment, which is an average of 16 weeks after Baseline)
B: Composite Clinician Severity Rating (CSR) on the Anxiety Disorders Interview Schedule (ADIS) for DSM-IV for primary anxiety diagnosis (Measured at Month 6 and Years 1, 2, 3, and 4 post-treatment)
C: Pediatric Anxiety Rating Scale (Measures the Severity of Anxiety Symptoms) (After an average of 16 weeks (Post-treatment))
D: Change in Diagnostic severity of social anxiety disorder (ADIS CSR score) (2 week and 6-month follow-up); Change in Treatment response/non-response (a CGI-I of Improved or better, ratings of 1-3, 3 = Improved) (2 week and 6-month follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Recovery After an Initial Schizophrenia Episode (RAISE): RAISE Early Treatment Program
Brief Summary: The purpose of this study is to determine how services should be provided to reduce symptoms and improve life functioning for adolescents and adults who have been recently diagnosed with schizophrenia.


Options:
A: Decisional conflict regarding the treatment for Generalized Anxiety Disorder, measured by the Decisional Conflict Scale (DCS) (Change from Baseline at 3 months after intervention)
B: Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time (Baseline, Month 6, month 12, month 18 and month 24)
C: Number of Participants Who Adhered to Physician Recommended Treatment (12 weeks)
D: Recruitment (From date of approaching surrogate decision maker for consent until the date of the first documented goals-of-care family meeting, assessed up to 1 month after admission.); Participation (1-36 hours after family meeting); Retention (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Recovery After an Initial Schizophrenia Episode (RAISE): RAISE Early Treatment Program
Brief Summary: The purpose of this study is to determine how services should be provided to reduce symptoms and improve life functioning for adolescents and adults who have been recently diagnosed with schizophrenia.


Options:
A: Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time (Baseline, Month 6, month 12, month 18 and month 24)
B: Rehospitalizations and psychotic relapse at two years
C: Number of Patients Hospitalized (1 year after enrollment)
D: Negative symptoms, measured with Schedule for Assessment of Negative Symptoms in Schizophrenia, (SANS) (3 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Recovery After an Initial Schizophrenia Episode (RAISE): RAISE Early Treatment Program
Brief Summary: The purpose of this study is to determine how services should be provided to reduce symptoms and improve life functioning for adolescents and adults who have been recently diagnosed with schizophrenia.


Options:
A: Time to Exacerbation of Psychotic Symptoms/Impending Relapse (Baseline of the depot maintenance phase to the end of the study (Week 52))
B: Time to Relapse or Impending Relapse (Up to 26 weeks post-randomization)
C: Time to Relapse During the Double-Blind Phase (Approximately Week 60)
D: Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time (Baseline, Month 6, month 12, month 18 and month 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Recovery After an Initial Schizophrenia Episode (RAISE): RAISE Early Treatment Program
Brief Summary: The purpose of this study is to determine how services should be provided to reduce symptoms and improve life functioning for adolescents and adults who have been recently diagnosed with schizophrenia.


Options:
A: transition to subthreshold psychosis (and psychosis or schizophrenia)
B: Perceived burden of care (Chinese version of the 25-item Family Burden Interview Schedule) (6 months (for Phases 1 and 2) after completion of intervention); Perceived burden of care (Chinese version of the 25-item Family Burden Interview Schedule) (12 months (for Phases 1 and 2) after completion of intervention); Perceived burden of care (Chinese version of the 25-item Family Burden Interview Schedule) (24 months (for Phase 2 only) after completion of intervention); Coping style (42-item Revised Ways of Coping Checklist) (6 months (for Phases 1 and 2) after completion of intervention); Coping style (42-item Revised Ways of Coping Checklist) (12 months (for Phases 1 and 2) after completion of intervention); Coping style (42-item Revised Ways of Coping Checklist) (24 months (for Phase 2 only) after completion of intervention)
C: Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time (Baseline, Month 6, month 12, month 18 and month 24)
D: Change in subthreshold psychotic (positive and negative) symptoms (Change from pretreatment (assessed for the 3 months prior to randomization) to 12 month reassessment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Recovery After an Initial Schizophrenia Episode (RAISE): RAISE Early Treatment Program
Brief Summary: The purpose of this study is to determine how services should be provided to reduce symptoms and improve life functioning for adolescents and adults who have been recently diagnosed with schizophrenia.


Options:
A: First recurrent suicide behavior (suicide attempted and completed suicide) (Minimum 1.5 year)
B: Brief Psychiatric Rating Scale, Expanded Version (BPRS-E) (12 months post-randomisation (18 months for secondary outcome))
C: Diabetes Distress - Change in Patient Reported Outcomes (PROs) (At end of 6 group visits (time differs by practice, up to 6 months))
D: Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time (Baseline, Month 6, month 12, month 18 and month 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Recovery After an Initial Schizophrenia Episode (RAISE): RAISE Early Treatment Program
Brief Summary: The purpose of this study is to determine how services should be provided to reduce symptoms and improve life functioning for adolescents and adults who have been recently diagnosed with schizophrenia.


Options:
A: Prognosis of patients. (6 months)
B: Functioning (social and occupational) (baseline, 6-month, 12-month, 24-month, 36-month, 48-month)
C: Negative symptoms, measured with Schedule for Assessment of Negative Symptoms in Schizophrenia, (SANS) (3 years)
D: Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time (Baseline, Month 6, month 12, month 18 and month 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Recovery After an Initial Schizophrenia Episode (RAISE): RAISE Early Treatment Program
Brief Summary: The purpose of this study is to determine how services should be provided to reduce symptoms and improve life functioning for adolescents and adults who have been recently diagnosed with schizophrenia.


Options:
A: UCSD Performance-based Skills Assessment Total Score (Measures Functional Capacity) (3 months)
B: Labor Market Participation in Ordinary Paid Employment, or Education. (1 year (2016))
C: Obtain Competitive Employment (1 calendar year)
D: Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time (Baseline, Month 6, month 12, month 18 and month 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Equitable Acces and Adherence to Secondary Prevention Therapy With a Fixed-Dose Combination Drug
Brief Summary: The aim of the FOCUS project is to test the Fixed Dose Combination concept for cardiovascular prevention in populations of different socio-economic characteristics. At the same time, FOCUS aims to understand the factors determining inappropriate prescribing for secondary cardiovascular prevention and those for poor patients adherence to treatment. This will allow FOCUS to establish recommendations for a better use of medication in patients with ischemic heart disease. In addition, after a successful completion of FOCUS, secondary prevention medication will be available and affordable for a large number of patients in both developed as well as developing countries.

There are two Phases in this study:

Phase 1: Is a descriptive, non interventional study. Phase 2: Is an interventional, randomized trial with prospective economic evaluation.


Options:
A: First occurrence of fatal or non-fatal acute MI, unstable angina, stroke, congestive heart failure, or revascularization (coronary bypass, stent insertion, or angioplasty) (2.5 years)
B: Adherence to the decision to use or not to use statins
C: Proportion of patients receiving AAS, an ACE inhibitor and a statin among those without contraindications to any of these drugs Adherence to treatment measured by: Morinsky-Green test and Pill accountability. (18 months); Adherence to treatment measured by the Morisky-Green questionnaire (18 months); Treatment adherence measured by: Morisky-Green test: (Good adherence score 16-20) at 1 and 9 months. (18 months); Treatment adherence measured by: Pill counts at 1-4-9 months. (Good adherence 80-110% PC) (18 months)
D: Change in proportion of pills taken compared to baseline (0-2months) at 8months; Between-group comparison of medication persistence at 14months

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Equitable Acces and Adherence to Secondary Prevention Therapy With a Fixed-Dose Combination Drug
Brief Summary: The aim of the FOCUS project is to test the Fixed Dose Combination concept for cardiovascular prevention in populations of different socio-economic characteristics. At the same time, FOCUS aims to understand the factors determining inappropriate prescribing for secondary cardiovascular prevention and those for poor patients adherence to treatment. This will allow FOCUS to establish recommendations for a better use of medication in patients with ischemic heart disease. In addition, after a successful completion of FOCUS, secondary prevention medication will be available and affordable for a large number of patients in both developed as well as developing countries.

There are two Phases in this study:

Phase 1: Is a descriptive, non interventional study. Phase 2: Is an interventional, randomized trial with prospective economic evaluation.


Options:
A: Reduction in blood Pressure (12 weeks); reduction in Heart Rate (12 weeks); modify lipids (12 weeks)
B: Proportion of patients receiving AAS, an ACE inhibitor and a statin among those without contraindications to any of these drugs Adherence to treatment measured by: Morinsky-Green test and Pill accountability. (18 months); Adherence to treatment measured by the Morisky-Green questionnaire (18 months); Treatment adherence measured by: Morisky-Green test: (Good adherence score 16-20) at 1 and 9 months. (18 months); Treatment adherence measured by: Pill counts at 1-4-9 months. (Good adherence 80-110% PC) (18 months)
C: LDL cholesterol (polypill evening vs polypill morning) (24 weeks); Mean 24 hour ambulatory systolic BP (polypill evening vs morning) (24 weeks)
D: Reduction of the Estimated 10-year Total Cardiovascular Risk Score (Six months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Equitable Acces and Adherence to Secondary Prevention Therapy With a Fixed-Dose Combination Drug
Brief Summary: The aim of the FOCUS project is to test the Fixed Dose Combination concept for cardiovascular prevention in populations of different socio-economic characteristics. At the same time, FOCUS aims to understand the factors determining inappropriate prescribing for secondary cardiovascular prevention and those for poor patients adherence to treatment. This will allow FOCUS to establish recommendations for a better use of medication in patients with ischemic heart disease. In addition, after a successful completion of FOCUS, secondary prevention medication will be available and affordable for a large number of patients in both developed as well as developing countries.

There are two Phases in this study:

Phase 1: Is a descriptive, non interventional study. Phase 2: Is an interventional, randomized trial with prospective economic evaluation.


Options:
A: Reduction in blood Pressure (12 weeks); reduction in Heart Rate (12 weeks); modify lipids (12 weeks)
B: Reduction of the Estimated 10-year Total Cardiovascular Risk Score (Six months)
C: Proportion of patients receiving AAS, an ACE inhibitor and a statin among those without contraindications to any of these drugs Adherence to treatment measured by: Morinsky-Green test and Pill accountability. (18 months); Adherence to treatment measured by the Morisky-Green questionnaire (18 months); Treatment adherence measured by: Morisky-Green test: (Good adherence score 16-20) at 1 and 9 months. (18 months); Treatment adherence measured by: Pill counts at 1-4-9 months. (Good adherence 80-110% PC) (18 months)
D: To evaluate the number of patients who reach target blood pressure (BP) and; LDL-C targets as defined by their governing guidelines.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A POPULATION-BASED DIRECT-TO-SMOKER OUTREACH OFFERING TOBACCO TREATMENT IN A HEALTH CARE SETTING: A RANDOMIZED CONTROLLED TRIAL
Brief Summary: Tobacco use is the leading preventable cause of death in the United States. Effective treatment for tobacco dependence exists and includes counseling and pharmacotherapy with nicotine replacement, bupropion, or varenicline. The health care system is a key channel for delivering this treatment to smokers. Brief clinical interventions delivered at office visits increase smoking cessation rates, are among the most cost-effective of medical interventions, and are recommended by U.S. Public Health Service. However, physicians and other clinicians often fail to provide them. Clinicians' rates of providing tobacco treatment in ambulatory care can be improved, but even when successful, clinicians can only reach smokers who make an office visit.

A health care system might improve its delivery of tobacco treatment by supplementing visit-based efforts with a population-based strategy, using methods proven effective in public health settings. A population of smokers could be identified from electronic health records and offered treatment proactively in a way that maximizes convenience and minimizes barriers such the cost of pharmacotherapy. This study tests the effectiveness of a population-based Direct-to-Smoker (DTS) outreach program provided to smokers in one community health center in Revere, MA, that is part of an integrated health care system. It uses the system's population management tools to identify smokers and proactively offers them evidence-based tobacco treatment that is free and does require making an office visit. A randomized controlled trial will compare the effectiveness of the DTS program to usual primary care. The hypothesis is that adding the DTS program to usual primary care will increase the proportion of smokers who use tobacco dependence treatment and thereby stop smoking.


Options:
A: Cotinine-validated 7-day point prevalence tobacco abstinence at 1 year follow-up; Cotinine-validated 7-day point prevalence tobacco abstinence at 3 month follow-up (end of treatment)
B: Safety: All-cause mortality (6 weeks); Safety: Readmission for any of CHF, unstable angina, arrhythmia, re-infarction, revascularization, stroke, or major bleeding requiring transfusion (6 weeks); Feasibility: Proportion of patients in the intervention group discharged within 72 hours ("feasible" if >= 70%); Feasibility: Proportion of patients in the intervention group who saw nurse practitioner within 3 days of discharge ("feasible" if >= 80%); Feasibility: Proportion of patients in the intervention group who saw nurse practitioner within 5 days of discharge ("feasible" if >= 90%)
C: Medication adherence; Exacerbation of heart failure; Health-related quality of life
D: proportion of participants who reported using any tobacco dependence treatment during the 3-month study period (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Diabetes Education During Retinal Ophthalmology Visits on Diabetes Control
Brief Summary: The purpose of this study is to assess whether glycemic control (assessed with HbA1c measurement) in individuals with type 1 or type 2 diabetes can be improved with a point-of-care measurement of HbA1c in the ophthalmologist's office combined with a personalized risk assessment for diabetic retinopathy and other complications of diabetes.


Options:
A: Change in HbA1c (12 Months)
B: Hemoglobin A1c (Baseline, 6 months)
C: Primary Process Outcome: A composite score counting the number of appropriate processes achieved for patients within appropriate time-frames, including laboratory testing, blood pressure measurements and active prescriptions (24 months); Primary Disease-Related Outcomes: mean BP and mean LDL level. (24 months)
D: Change from baseline in HbAlc level; percentage of subjects reaching or maintaining the risk target (represented by a combination of LBGI<=2.5 together with HBGI<=5). (Visit 5 (52 weeks after Visit 1 +/- 2 weeks).)

Answer: A