TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Diabetes Care With Patient Decision Aids - A Randomized Controlled Trial in Community-based Primary Care
Brief Summary: Mounting evidence documents the positive impact of using patient decision aids (PtDA) to facilitate shared decision-making (SDM) between patients and physicians in preference sensitive contexts. But overall use of PtDAs across the broader US healthcare system remains low. More compelling evidence is needed to make the case for policies that would accelerate adoption of PtDAs in routine clinical practice in primary care settings that serve diverse and economically disadvantaged populations. The investigators believe that it is now time to move beyond the subjective evaluations of PtDAs that are commonly reported in clinical trials of PtDAs, to evaluate whether these tools can also change health behavior and improve health outcomes. Therefore, the investigators will build on their expertise in working with community-based physicians to evaluate a newly developed PtDA focused on diabetes, using a mixed-methods approach. The investigators patient sample will be drawn from primary care practices serving African American, Latino and Caucasian patients. The investigators will conduct a 2-group randomized controlled trial to evaluate the effects of the diabetes PtDA, combined with telephone coaching, in increasing patient self-care and self-efficacy, increasing diabetes knowledge and improving clinical measures including glycosylated hemoglobin A1c, lipids and blood pressure. The investigators will also explore variation in effects of the patient decision aid, comparing African American, Latino and Caucasian patients and conduct in-depth interviews with a randomly selected subset of trial participants to explore patient perceptions of the decision aid and variation across racial/ethnic groups. The investigators hypothesize that, compared to the control condition, participants assigned to receiving the video PtDA program and telephone coaching will report: greater self-efficacy and diabetes knowledge, more engagement in self-care behaviors, better glycemic control as measured by hemoglobin A1c, as well as lower quantitative LDL and blood pressure levels. The conceptual model guiding the investigators trial is the Integrative Model of Behavior Change. The model includes three primary determinants of behavior:

1. attitudes toward performing the behavior
2. perceived social norms about performing the behavior
3. self-efficacy. The investigators expect the diabetes PtDA to affect each of these constructs directly or indirectly.


Options:
A: Changes of glycosilated haemoglobin (HbA1c) (At least 12 weeks from baseline (visit 3))
B: Rate of LDL cholesterol control (< 100 mg/dL) (12 months); Rate of blood pressure control (< 130/80 mmHg) (12 months); Rate of HbA1c control (<7%) (12 months)
C: Death and/or ESRD defined as need for dialysis or plasma creatinine 500mmol/l (May 2003 - Dec 2007)
D: Hemoglobin A1c (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Diabetes Care With Patient Decision Aids - A Randomized Controlled Trial in Community-based Primary Care
Brief Summary: Mounting evidence documents the positive impact of using patient decision aids (PtDA) to facilitate shared decision-making (SDM) between patients and physicians in preference sensitive contexts. But overall use of PtDAs across the broader US healthcare system remains low. More compelling evidence is needed to make the case for policies that would accelerate adoption of PtDAs in routine clinical practice in primary care settings that serve diverse and economically disadvantaged populations. The investigators believe that it is now time to move beyond the subjective evaluations of PtDAs that are commonly reported in clinical trials of PtDAs, to evaluate whether these tools can also change health behavior and improve health outcomes. Therefore, the investigators will build on their expertise in working with community-based physicians to evaluate a newly developed PtDA focused on diabetes, using a mixed-methods approach. The investigators patient sample will be drawn from primary care practices serving African American, Latino and Caucasian patients. The investigators will conduct a 2-group randomized controlled trial to evaluate the effects of the diabetes PtDA, combined with telephone coaching, in increasing patient self-care and self-efficacy, increasing diabetes knowledge and improving clinical measures including glycosylated hemoglobin A1c, lipids and blood pressure. The investigators will also explore variation in effects of the patient decision aid, comparing African American, Latino and Caucasian patients and conduct in-depth interviews with a randomly selected subset of trial participants to explore patient perceptions of the decision aid and variation across racial/ethnic groups. The investigators hypothesize that, compared to the control condition, participants assigned to receiving the video PtDA program and telephone coaching will report: greater self-efficacy and diabetes knowledge, more engagement in self-care behaviors, better glycemic control as measured by hemoglobin A1c, as well as lower quantitative LDL and blood pressure levels. The conceptual model guiding the investigators trial is the Integrative Model of Behavior Change. The model includes three primary determinants of behavior:

1. attitudes toward performing the behavior
2. perceived social norms about performing the behavior
3. self-efficacy. The investigators expect the diabetes PtDA to affect each of these constructs directly or indirectly.


Options:
A: Hemoglobin A1c (6 months)
B: Patient knowledge (Immediately after patient visit)
C: Test if Chest Pain Choice Safely Improves Patient Knowledge. (Directly following intervention (on day 1))
D: The following dependant variables were measured in this study;; Diabetes medical error in the 12 months post-intervention, Glycated hemoglobin (A1c) values and A1c test rates in the 12 months post-intervention, and; LDL-cholesterol levels and test rates in the 12 months post-intervention.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Diabetes Care With Patient Decision Aids - A Randomized Controlled Trial in Community-based Primary Care
Brief Summary: Mounting evidence documents the positive impact of using patient decision aids (PtDA) to facilitate shared decision-making (SDM) between patients and physicians in preference sensitive contexts. But overall use of PtDAs across the broader US healthcare system remains low. More compelling evidence is needed to make the case for policies that would accelerate adoption of PtDAs in routine clinical practice in primary care settings that serve diverse and economically disadvantaged populations. The investigators believe that it is now time to move beyond the subjective evaluations of PtDAs that are commonly reported in clinical trials of PtDAs, to evaluate whether these tools can also change health behavior and improve health outcomes. Therefore, the investigators will build on their expertise in working with community-based physicians to evaluate a newly developed PtDA focused on diabetes, using a mixed-methods approach. The investigators patient sample will be drawn from primary care practices serving African American, Latino and Caucasian patients. The investigators will conduct a 2-group randomized controlled trial to evaluate the effects of the diabetes PtDA, combined with telephone coaching, in increasing patient self-care and self-efficacy, increasing diabetes knowledge and improving clinical measures including glycosylated hemoglobin A1c, lipids and blood pressure. The investigators will also explore variation in effects of the patient decision aid, comparing African American, Latino and Caucasian patients and conduct in-depth interviews with a randomly selected subset of trial participants to explore patient perceptions of the decision aid and variation across racial/ethnic groups. The investigators hypothesize that, compared to the control condition, participants assigned to receiving the video PtDA program and telephone coaching will report: greater self-efficacy and diabetes knowledge, more engagement in self-care behaviors, better glycemic control as measured by hemoglobin A1c, as well as lower quantitative LDL and blood pressure levels. The conceptual model guiding the investigators trial is the Integrative Model of Behavior Change. The model includes three primary determinants of behavior:

1. attitudes toward performing the behavior
2. perceived social norms about performing the behavior
3. self-efficacy. The investigators expect the diabetes PtDA to affect each of these constructs directly or indirectly.


Options:
A: HbA1c level (6 months)
B: Blood pressure at target level (140/85 or lower), total cholesterol at target level (4.5 mmol/l or lower), LDL cholesterol at target level (2.5 mmol/l or below), waist circumference at target level (<=94 men, <=80 cm women) (12 months from start of intervention); For patients with diabetes: blood HbA1c at target level (7% or less) (12 months from start of intervention)
C: N/A
D: Hemoglobin A1c (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Vascular Findings Between Symptomatic and Asymptomatic Postmenopausal Women Before and During Hormone Therapy: A Randomized, Placebo-controlled Prospective Study
Brief Summary: Recent large randomized, placebo-controlled studies assessing the health effects of HT question the overall benefits of long term HT, especially with respect to cardiovascular disease. However, recently menopausal women with severe hot flushes were mostly excluded from these trials. This was unfortunate since vasomotor symptoms may reflect different vascular sensitivity to estrogen or its deficiency, and therefore, the vascular responses to HT in women with and without hot flushes can differ.

Aims of the present project are

1. to compare vascular, cardiac and sympathetic function in recently menopausal women with or without severe vasomotor symptoms
2. in a randomized placebo controlled clinical trial investigate vascular response to oral and trans-dermal HT.


Options:
A: Vascular function (0 and 6 months)
B: To evaluate the effects of Bazedoxifene/Conjugate Estrogens (CE) combinations on the incidence of endometrial hyperplasia in postmenopausal women. (one year)
C: female sexual function index score (8 weeks)
D: Change From Baseline in the Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear at Week 12 (Baseline and Week 12); Change From Baseline in the Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear at Week 12 (Baseline and Week 12); Change From Baseline in the Vaginal pH at Week 12 (Baseline and Week 12); Change From Baseline in the Severity of Self-reported Most Bothersome Symptom (MBS) of Vaginal Dryness at Week 12 (Baseline and Week 12); Number of Participants With Adverse Events (From the first dose of study drug up to 14 days after the last dose; 14 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Follow-up Study to Evaluate Sustained Clearance Rates of Actinic Keratoses up to One Year After Completion of Studies GW01-0702, GW01-0703, GW01-0704, and GW01-0705
Brief Summary: The objective of this study was to obtain long-term sustained clearance rates for subjects previously treated with imiquimod creams in studies GW01-0702, GW01-0703, GW01-0704 and GW01-0705.


Options:
A: Complete Clearance of Actinic Keratoses (AK) Lesions (baseline and 57 days)
B: Patients With Complete Clearance of Actinic Keratosis (AKs) (57 days)
C: Number of Participants With Recurrence of AK Lesions (Up to one year)
D: Proportion of Patients With Complete Clearance of Actinic Keratoses (AK) Lesions (57 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Fase IV Clinical Trial to Evaluate Chondroitin Sulphate Efficacy and Safety in Patients With Knee Osteoarthritis and Psoriasis
Brief Summary: The purpouse of this study is to determine the efficacy and safety of chondroitin sulphate conventional treatment in patients with both knee osteoarthritis and plaque psoriasis.


Options:
A: Lequesne Index
B: Huskisson Visual Analogue Scale (Monthly); Psoriasis Area and Severity Index (Monthly)
C: Change in Global Spontaneous Pain Intensity of Target Hand (6 months); Change in Functional Index for Hand Osteoarthritis Dreiser's Score (FIHOA) in the Target Hand (6 month)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Intracoronary Stem Cell Therapy in Patients With Acute Myocardial Infarction - A Randomized, Double-blind, Placebo Controlled Trial (SCAMI)
Brief Summary: Autologous stem cells may improve myocardial regeneration after intracoronary administration in patients with acute myocardial infarction. The primary hypothesis of this prospective, placebo-controlled, double-blind trial is that the increase of ejection fraction determined by magnetic resonance imaging between baseline and 6 months follow-up is superior in active treated patients compared to patients receiving placebo. The study includes an integrated pilot phase of 40 patients for evaluation of left ventricular ejection fraction determined by cardiac magnetic resonance imaging. Based on the data of this analysis the final sample size will be calculated. The primary endpoint is the improvement in left ventricular ejection fraction with an assumed 2.5% higher improvement in the cell treated population compared to the placebo treated group.


Options:
A: Comparison of treatment adverse event rates between the 0.5, 1.6 and 5.0 million mesenchymal stem cells per kilogram dose cohorts and placebo groups. (6 months)
B: Global Left Ventricular Function (Measured at Baseline and Month 6); Regional Left Ventricular Function (Infarct Zone Wall Motion) (Measured at Baseline and Month 6); Regional Left Ventricular Function (Border Zone Wall Motion) (Measured at Baseline and Month 6)
C: Arrhythmia risk variables; left ventricular function; restenosis assessed by IVUS
D: difference in left ventricular ejection fraction measured by magnetic resonance imaging at baseline and 6 months follow-up (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Rescue Antenatal Steroids and Lung Volumes in Preterm Infants
Brief Summary: One course of steroids given to a mother before a premature delivery helps the lungs of the premature infant and decreases breathing problems. One course of antenatal steroids is the standard of care for threatened premature deliveries. It is unclear as to how long the benefit of one course of steroids last. The most benefit to the baby's lungs seem to occur if the steroids are given at least 24 hours before but within 7 days of a premature delivery. It is difficult to predict the timing of a preterm delivery so deliveries often do not occur within this time period. We hypothesize that the benefits of the steroids to the lungs wear off if the steroids are given more than 14 days before a preterm delivery, and that in these circumstances an extra course of steroids will help the premature baby's lungs and the premature baby will have less breathing problems as shown by lung function testing.


Options:
A: Measurements of Functional Residual Capacity in Preterm Infants. (Within first 72 hours after birth); Measurements of Respiratory Compliance (Crs) in Preterm Infants. (Within first 72 hours after birth)
B: Neonatal Composite Outcome (72 hours of life)
C: Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity) (Birth to 28 days)
D: Composite outcome: including neonatal mortality/stillbirth, severe RDS, chronic lung disease, grade III/IV IVH, PVL

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Rescue Antenatal Steroids and Lung Volumes in Preterm Infants
Brief Summary: One course of steroids given to a mother before a premature delivery helps the lungs of the premature infant and decreases breathing problems. One course of antenatal steroids is the standard of care for threatened premature deliveries. It is unclear as to how long the benefit of one course of steroids last. The most benefit to the baby's lungs seem to occur if the steroids are given at least 24 hours before but within 7 days of a premature delivery. It is difficult to predict the timing of a preterm delivery so deliveries often do not occur within this time period. We hypothesize that the benefits of the steroids to the lungs wear off if the steroids are given more than 14 days before a preterm delivery, and that in these circumstances an extra course of steroids will help the premature baby's lungs and the premature baby will have less breathing problems as shown by lung function testing.


Options:
A: Incidence of respiratory morbidity (72 hours after birth)
B: Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity) (Birth to 28 days)
C: Measurements of Functional Residual Capacity in Preterm Infants. (Within first 72 hours after birth); Measurements of Respiratory Compliance (Crs) in Preterm Infants. (Within first 72 hours after birth)
D: neonatal respiratory distress (neonatal period (28 days of life))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Rescue Antenatal Steroids and Lung Volumes in Preterm Infants
Brief Summary: One course of steroids given to a mother before a premature delivery helps the lungs of the premature infant and decreases breathing problems. One course of antenatal steroids is the standard of care for threatened premature deliveries. It is unclear as to how long the benefit of one course of steroids last. The most benefit to the baby's lungs seem to occur if the steroids are given at least 24 hours before but within 7 days of a premature delivery. It is difficult to predict the timing of a preterm delivery so deliveries often do not occur within this time period. We hypothesize that the benefits of the steroids to the lungs wear off if the steroids are given more than 14 days before a preterm delivery, and that in these circumstances an extra course of steroids will help the premature baby's lungs and the premature baby will have less breathing problems as shown by lung function testing.


Options:
A: Neonatal Composite Outcome (72 hours of life)
B: Measurements of Functional Residual Capacity in Preterm Infants. (Within first 72 hours after birth); Measurements of Respiratory Compliance (Crs) in Preterm Infants. (Within first 72 hours after birth)
C: Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity) (Birth to 28 days)
D: neonatal respiratory distress (neonatal period (28 days of life))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Rescue Antenatal Steroids and Lung Volumes in Preterm Infants
Brief Summary: One course of steroids given to a mother before a premature delivery helps the lungs of the premature infant and decreases breathing problems. One course of antenatal steroids is the standard of care for threatened premature deliveries. It is unclear as to how long the benefit of one course of steroids last. The most benefit to the baby's lungs seem to occur if the steroids are given at least 24 hours before but within 7 days of a premature delivery. It is difficult to predict the timing of a preterm delivery so deliveries often do not occur within this time period. We hypothesize that the benefits of the steroids to the lungs wear off if the steroids are given more than 14 days before a preterm delivery, and that in these circumstances an extra course of steroids will help the premature baby's lungs and the premature baby will have less breathing problems as shown by lung function testing.


Options:
A: Intact survival without RDS and/or severe (gr 3-4) ICH; Follow-up study at corrected age of two years
B: MACS: Perinatal or neonatal mortality or serious neonatal morbidity; MACS-5: Mortality or survival with severe neuro-morbidities at 5 years of age
C: Measurements of Functional Residual Capacity in Preterm Infants. (Within first 72 hours after birth); Measurements of Respiratory Compliance (Crs) in Preterm Infants. (Within first 72 hours after birth)
D: Composite outcome: including neonatal mortality/stillbirth, severe RDS, chronic lung disease, grade III/IV IVH, PVL

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Rescue Antenatal Steroids and Lung Volumes in Preterm Infants
Brief Summary: One course of steroids given to a mother before a premature delivery helps the lungs of the premature infant and decreases breathing problems. One course of antenatal steroids is the standard of care for threatened premature deliveries. It is unclear as to how long the benefit of one course of steroids last. The most benefit to the baby's lungs seem to occur if the steroids are given at least 24 hours before but within 7 days of a premature delivery. It is difficult to predict the timing of a preterm delivery so deliveries often do not occur within this time period. We hypothesize that the benefits of the steroids to the lungs wear off if the steroids are given more than 14 days before a preterm delivery, and that in these circumstances an extra course of steroids will help the premature baby's lungs and the premature baby will have less breathing problems as shown by lung function testing.


Options:
A: Measurements of Functional Residual Capacity in Preterm Infants. (Within first 72 hours after birth); Measurements of Respiratory Compliance (Crs) in Preterm Infants. (Within first 72 hours after birth)
B: Intact survival without RDS and/or severe (gr 3-4) ICH; Follow-up study at corrected age of two years
C: MACS: Perinatal or neonatal mortality or serious neonatal morbidity; MACS-5: Mortality or survival with severe neuro-morbidities at 5 years of age
D: Composite outcome: including neonatal mortality/stillbirth, severe RDS, chronic lung disease, grade III/IV IVH, PVL

Answer: A