TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Safety, Tolerability and Immunogenicity of Adjuvanted Candidate Vaccines Against Pandemic Influenza A (H1N1)
Brief Summary: This is a prospective phase I study to evaluate the safety, tolerability and immunogenicity of nine adjuvanted candidate vaccines against pandemic influenza A (H1N1) virus.


Options:
A: Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. (At Day 0 and Day 21)
B: Adverse Pregnancy Outcomes (0-28 days postpartum)
C: Serum anti pneumococcal polysaccharide IgG antibody at 20 weeks of age; local and systemic reactions within 2 weeks of vaccination
D: the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay (21 days after each vaccination)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo-Controlled, Parallel Group, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of Tramadol HCl/Acetaminophen Extended Release Tablet in Subjects With Chronic Low Back Pain
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of extended release (ER) tramadol hydrochloride (HCl)/acetaminophen compared with placebo in participants with chronic (lasting a long time) low-back pain.


Options:
A: Percentage of Participants With Reduction in Pain Intensity (Baseline up to Day 29); Change From Baseline in Pain Intensity at Day 29 (Baseline and Day 29)
B: Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 16: Baseline Observation Carried Forward (BOCF) (Baseline, Week 16)
C: Decreased pain (Baseline, 2 weeks, 4 weeks)
D: SF-36, Roland Morris Disability Questionnaire, Quebec back pain disability (before intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Breast Cancer Recurrence With Weight Loss: A Vanguard Trial
Brief Summary: The purpose of the ENERGY trial is to explore whether two different programs that are focused on weight management, through increased exercise and a healthy diet, are feasible, and have an impact on body weight, quality of life and fatigue. Since obesity among breast cancer survivors is associated with recurrence and other co-morbidities, those will be assessed and their impact calculated. Blood samples will be collected to enable analysis of potential mechanisms and differential response across subgroups.


Options:
A: Weight loss (2 years)
B: Physical function as assessed by Short-Form Health Survey (SF-36) with physical function subscale and late effects lower body subscales at baseline and years 1 and 2 following study completion (one year)
C: Quality of life as measured by Functional Assessment of Cancer Therapy for General Cancer (FACT-G) and Functional Assessment of Cancer Therapy for Fatigue (FACT-F) at baseline, 3, 6, and 12 months (baseline, 3, 6, and 12 months); Weight loss as measured by weight, body mass index (BMI), waist circumference, Weight Efficacy Life Style Questionnaire, Three Factor Eating Inventory Questionnaire, and Leisure Score index at baseline, 3, 6, and 12 months (baseline, 3, 6, and 12 months); Functional status as measured by ECOG performance status, and short-form health survey with 36 questions (SF-36) (baseline, 3, 6, and 12 months); Comorbidities as measured by Charlson Co-Morbidity Score at baseline, 3, 6, and 12 months (baseline, 3, 6, and 12 months)
D: Weight loss (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Breast Cancer Recurrence With Weight Loss: A Vanguard Trial
Brief Summary: The purpose of the ENERGY trial is to explore whether two different programs that are focused on weight management, through increased exercise and a healthy diet, are feasible, and have an impact on body weight, quality of life and fatigue. Since obesity among breast cancer survivors is associated with recurrence and other co-morbidities, those will be assessed and their impact calculated. Blood samples will be collected to enable analysis of potential mechanisms and differential response across subgroups.


Options:
A: Physical function as assessed by Short-Form Health Survey (SF-36) with physical function subscale and late effects lower body subscales at baseline and years 1 and 2 following study completion (one year)
B: Change in FACIT-TS questionnaire score (Baseline, 6 months)
C: Weight loss maintenance (6 - 18 months)
D: Weight loss (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Breast Cancer Recurrence With Weight Loss: A Vanguard Trial
Brief Summary: The purpose of the ENERGY trial is to explore whether two different programs that are focused on weight management, through increased exercise and a healthy diet, are feasible, and have an impact on body weight, quality of life and fatigue. Since obesity among breast cancer survivors is associated with recurrence and other co-morbidities, those will be assessed and their impact calculated. Blood samples will be collected to enable analysis of potential mechanisms and differential response across subgroups.


Options:
A: Quality of life as measured by Functional Assessment of Cancer Therapy for General Cancer (FACT-G) and Functional Assessment of Cancer Therapy for Fatigue (FACT-F) at baseline, 3, 6, and 12 months (baseline, 3, 6, and 12 months); Weight loss as measured by weight, body mass index (BMI), waist circumference, Weight Efficacy Life Style Questionnaire, Three Factor Eating Inventory Questionnaire, and Leisure Score index at baseline, 3, 6, and 12 months (baseline, 3, 6, and 12 months); Functional status as measured by ECOG performance status, and short-form health survey with 36 questions (SF-36) (baseline, 3, 6, and 12 months); Comorbidities as measured by Charlson Co-Morbidity Score at baseline, 3, 6, and 12 months (baseline, 3, 6, and 12 months)
B: Recruitment Rate (Percentage of Potentially Eligible Participants Who Were Enrolled to the Study) (6 months)
C: Physical function as assessed by Short-Form Health Survey (SF-36) with physical function subscale and late effects lower body subscales at baseline and years 1 and 2 following study completion (one year)
D: Weight loss (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Breast Cancer Recurrence With Weight Loss: A Vanguard Trial
Brief Summary: The purpose of the ENERGY trial is to explore whether two different programs that are focused on weight management, through increased exercise and a healthy diet, are feasible, and have an impact on body weight, quality of life and fatigue. Since obesity among breast cancer survivors is associated with recurrence and other co-morbidities, those will be assessed and their impact calculated. Blood samples will be collected to enable analysis of potential mechanisms and differential response across subgroups.


Options:
A: Change in weight (6 months); change in weight (12 months)
B: Changes of health-related physical fitness components (1). (Changes from baseline aerobic capacity at 12 weeks); Changes of health-related physical fitness components (2). (Changes from baseline muscular endurance at 12 weeks); Changes of health-related physical fitness components (3). (Changes from baseline muscular strength at 12 weeks); Changes of health-related physical fitness components (4). (Changes from baseline muscular power at 12 weeks); Changes of health-related physical fitness components (5). (Changes from baseline agility at 12 weeks); Changes of health-related physical fitness components (6). (Changes from baseline flexibility at 12 weeks); Changes of anthropometric parameters (1). (Changes from baseline waist circumference at 12 weeks); Changes of anthropometric parameters (2). (Changes from baseline BMI at 12 weeks); Changes of body composition parameters (1). (Changes from baseline body fat mass at 12 weeks); Changes of body composition parameters (2). (Changes from baseline lean body mass at 12 weeks); Changes of body composition parameters (3). (Changes from baseline percentage body fat at 12 weeks); Changes of serum levels of Wnt signaling-related molecules (1). (Changes from baseline serum levels of DKK1 at 12 weeks); Changes of serum levels of Wnt signaling-related molecules (2). (Changes from baseline serum levels of Sclerostin at 12 weeks); Changes of serum levels of Wnt signaling-related molecules (3). (Changes from baseline serum levels of SFRP1 at 12 weeks); Changes of serum levels of Wnt signaling-related molecules (4). (Changes from baseline serum levels of β-catenin at 12 weeks); Changes of serum levels of Wnt signaling-related molecules (5). (Changes from baseline serum levels of WISP-1 at 12 weeks)
C: Weight loss (2 years)
D: Proportion of participants with completed assessments at 6 months (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D Dose-response Study Throughout Pregnancy and Lactation
Brief Summary: Background: Vitamin D is vital throughout pregnancy and lactation for both maternal and infant health. Health Canada recommends women take the AI of 5ug/day of vitamin D during pregnancy, however, it is unknown how much vitamin D is necessary to ensure both mother and baby reach a vitamin D serum concentration of 25OHD\>75nmol/L.


Options:
A: Persistent wheeze 0 to 3 years of age (3 years)
B: 25(OH)D Plasma Concentrations (18 weeks gestation for mother); 25(OH)D Plasma Concentrations (28 weeks gestation for mother); 25(OH)D Plasma Concentrations (36 weeks gestation for mother); 25(OH)D Plasma Concentrations (16 weeks post-partum for mother & infant)
C: Serum 25-hydroxyvitamin D in pregnant women and cord blood (Change from 1st through 2nd trimester and at delivery)
D: Weight, length and Rohrer index at birth, and gestational duration in single pregnancies. (At birth); Mortality, morbidity and growth during the first year of life (Monthly during infancy)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D Dose-response Study Throughout Pregnancy and Lactation
Brief Summary: Background: Vitamin D is vital throughout pregnancy and lactation for both maternal and infant health. Health Canada recommends women take the AI of 5ug/day of vitamin D during pregnancy, however, it is unknown how much vitamin D is necessary to ensure both mother and baby reach a vitamin D serum concentration of 25OHD\>75nmol/L.


Options:
A: 25(OH)D Plasma Concentrations (18 weeks gestation for mother); 25(OH)D Plasma Concentrations (28 weeks gestation for mother); 25(OH)D Plasma Concentrations (36 weeks gestation for mother); 25(OH)D Plasma Concentrations (16 weeks post-partum for mother & infant)
B: Infant Length-for-Age Z-Scores with Prenatal Supplementation (1 year of age); Infant Length-for-Age Z-Scores with Postpartum Supplementation (1 year of age)
C: Microbiologically confirmed viral acute respiratory infection (URTI and/or LRTI) (0 to 6 months)
D: The proportions of women who will reach the IOM defined desirable 25(OH)D level ≥20ng/ml. (At delivery); Infant bone mineral content (BMC) (one to six weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D Dose-response Study Throughout Pregnancy and Lactation
Brief Summary: Background: Vitamin D is vital throughout pregnancy and lactation for both maternal and infant health. Health Canada recommends women take the AI of 5ug/day of vitamin D during pregnancy, however, it is unknown how much vitamin D is necessary to ensure both mother and baby reach a vitamin D serum concentration of 25OHD\>75nmol/L.


Options:
A: Infant Length-for-Age Z-Scores with Prenatal Supplementation (1 year of age); Infant Length-for-Age Z-Scores with Postpartum Supplementation (1 year of age)
B: 25(OH)D Plasma Concentrations (18 weeks gestation for mother); 25(OH)D Plasma Concentrations (28 weeks gestation for mother); 25(OH)D Plasma Concentrations (36 weeks gestation for mother); 25(OH)D Plasma Concentrations (16 weeks post-partum for mother & infant)
C: Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement (12, 16, 28 weeks and at maternal delivery and neonatal birth)
D: Differences in maternal bone mass changes postpartum between supplemented and placebo groups (2, 5 and 12 months postpartum); Differences in fetal growth and infant bone mass between supplemented and placebo groups (2nd and 3rd trimester gestation and 2 mo postpartum)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impact of Acupuncture as an Adjunct to Pulmonary Rehabilitation
Brief Summary: The hypothesis of this study was that acupuncture in conjunction with standard care of pulmonary rehabilitation improves outcome measures compared to pulmonary rehabilitation alone.


Options:
A: Proactive tool (clinical visit version) (7 days)
B: Change in Health Related quality-of-life: St. George Respiratory Questionnaire (Up to 9 months)
C: Quality of life score, St George's Quality of Life score (Initial, 8 weeks and 3 months)
D: pulmonary function（FEV1） (Change from Baseline in FEV1 at Week 26 and 52 of the treatment phase, Week 26 and 52 of the followup phase); the frequency of exacerbation (Change from Baseline in the frequency of exacerbation at Week 26 and 52 of the treatment phase, Week 26 and 52 of the followup phase)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impact of Acupuncture as an Adjunct to Pulmonary Rehabilitation
Brief Summary: The hypothesis of this study was that acupuncture in conjunction with standard care of pulmonary rehabilitation improves outcome measures compared to pulmonary rehabilitation alone.


Options:
A: The two primary outcomes are disease-specific quality of life assessed with the St. George's Respiratory Questionnaire (SGRQ) and the total number of exacerbations
B: Number of hospital admissions for exacerbations of COPD
C: Quality of life score, St George's Quality of Life score (Initial, 8 weeks and 3 months)
D: An increase of the six-minute walking distance by more than 50 m with an improvement in health-related quality-of-life.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1 Randomized Double-Blind Placebo-Crossover Safety Trial of DAS181 (Fludase®) in Adult Subjects With Well-Controlled Asthma or Bronchiectasis
Brief Summary: The primary objective is to evaluate whether DAS181 is safe in subjects with well-controlled asthma or bronchiectasis.


Options:
A: FEV1 peak0-3 Change From Baseline (Baseline and 24 weeks)
B: Change in Percentage of participants using controller medications for asthma from baseline to 12 month follow-up (Baseline, 12)
C: Airway response to inhaled allergen (at time of allergen inhalation challenge and for 7 hours after)
D: Safety and toxicity profile: Unacceptable Serious Adverse Events (6 weeks (up to 12 weeks))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Combined Use of Oxytocin and Misoprostol in the Prevention of Post Partum Haemorrhage
Brief Summary: To demonstrate that the combined used of oxytocin and misoprostol prevent from post partum haemorrhage better than oxytocin alone, following vaginal birth at 36 to 42 weeks.


Options:
A: postpartum hemorrhage-1 (after delivery of baby); postpartum hemorrhage-2 (after delivery of the baby); postpartum hemorrhage-3 (after delivery of the baby)
B: Occurrence of post partum hemorrhage > 500mL in 1 hour (1 HOUR)
C: postpartum bleeding in the third stage of labour (participants will be followed for the duration of hospital stay, an expected average of 48 hours)
D: Number of Subjects Reporting Uterine Atony or Postpartum Hemorrhage Requiring Medical (Medication or Blood Transfusion), Surgical or Other Interventional Treatment (baseline to discharge (2 - 3 days)); Women in Each Group With Risk Factors for Atony or Postpartum Hemorrhage (Initial hospital discharge (2-3 days)); Risk to Using Increasing Doses of Oxytocin Based on Pre-specified Risk Factors (baseline to discharge (2-3 days))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Combined Use of Oxytocin and Misoprostol in the Prevention of Post Partum Haemorrhage
Brief Summary: To demonstrate that the combined used of oxytocin and misoprostol prevent from post partum haemorrhage better than oxytocin alone, following vaginal birth at 36 to 42 weeks.


Options:
A: Occurrence of post partum hemorrhage > 500mL in 1 hour (1 HOUR)
B: The amount of blood loss in the third and fourth stages (the fourth stage of labor begins with delivery of the placenta and ends 2 hours after delivery) of labor. (2 hours)
C: Maximal uterine tone (within the first 5 minutes after cord clamping)
D: To evaluate the efficacy of buccal misoprostol in the prevention of uterine atony and postpartum hemorrhage (PPH) after caesarean section (an expected average 1 week)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Combined Use of Oxytocin and Misoprostol in the Prevention of Post Partum Haemorrhage
Brief Summary: To demonstrate that the combined used of oxytocin and misoprostol prevent from post partum haemorrhage better than oxytocin alone, following vaginal birth at 36 to 42 weeks.


Options:
A: screening of Cessation of bleeding (screening until 24 hours after placenta disconnection); time duration to stop bleeding in the case of post-cesarean section (24 hours)
B: Mean change in hemoglobin (during 3rd trimester and 1-3 days postpartum)
C: Estimated Blood loss (24 hours)
D: Occurrence of post partum hemorrhage > 500mL in 1 hour (1 HOUR)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Decision Making About Feeding Options for Dementia
Brief Summary: This study is a randomized trial to test whether a decision aid can help to improve the quality of decision making about feeding options in care of patients with dementia.


Options:
A: Patient's satisfaction and confidence with the information given. (Within two weeks after receiving the information and after 3 months.)
B: Understanding (Directly proceeding the clinical encounter); Decisional Conflict (Directly proceeding the clinical visit); Treatment Action, adherence (Directly proceeding the clinical encounter, 6 months after the clinical encounter)
C: Decisional Conflict Scale (3 months)
D: Clinical inertia (12 month post intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Decision Making About Feeding Options for Dementia
Brief Summary: This study is a randomized trial to test whether a decision aid can help to improve the quality of decision making about feeding options in care of patients with dementia.


Options:
A: Documented Decisions to Forgo Hospitalization (by six months)
B: Change From Baseline in Severe Impairment Battery (SIB) at Week 24 (LOCF) (Baseline to week 24); Clinician's Interview-Based Impression of Change With Caregiver Input (CIBIC-plus) at Week 24 (LOCF) (Week 24)
C: Decisional Conflict Scale (3 months)
D: Change in scores from baseline to week 26 on measuring cognition Severe Impairment Battery test and the Minimum Data Set Activities of Daily Living test.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Decision Making About Feeding Options for Dementia
Brief Summary: This study is a randomized trial to test whether a decision aid can help to improve the quality of decision making about feeding options in care of patients with dementia.


Options:
A: Change in scores from baseline to week 26 on measuring cognition Severe Impairment Battery test and the Minimum Data Set Activities of Daily Living test.
B: Change From Baseline in Severe Impairment Battery (SIB) at Week 24 (LOCF) (Baseline to week 24); Clinician's Interview-Based Impression of Change With Caregiver Input (CIBIC-plus) at Week 24 (LOCF) (Week 24)
C: Decisional Conflict Scale (3 months)
D: Changes in Neuropsychiatric Inventory (24 weeks); Changes in Cornell's Depression Scale (24 weeks); Changes in UPDRS subscale (24 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Decision Making About Feeding Options for Dementia
Brief Summary: This study is a randomized trial to test whether a decision aid can help to improve the quality of decision making about feeding options in care of patients with dementia.


Options:
A: Change in serum LDL-cholesterol level (at 6 months post disclosure of CAD risk)
B: Decisional Conflict Scale (3 months)
C: Mean Patient-centered Communication in Advanced Cancer Score (3 years)
D: Glycaemic control measured by HbA1c (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Exercise Conditioning in Elderly Patients With Heart Failure
Brief Summary: The purpose of this study is :

* To determine if aerobic exercise conditioning can improve symptoms, cardiovascular function and quality of life in elderly patients with congestive heart failure.
* To describe the baseline clinical characteristics, cardiovascular function and neurohumoral function in elderly patients with congestive heart failure.
* To determine the specific cardiovascular and noncardiovascular mechanisms by which symptoms and quality of life may improve following exercise conditioning in elderly patients with congestive heart failure.


Options:
A: Peak exercise capacity (16 weeks)
B: HF-specific quality of life (baseline, midpoint, endpoint, 6mo); functional capacity (baseline and endpoint); Walking Test (baseline, midpoint, endpoint)
C: Peak oxygen uptake
D: Composite of all-cause mortality and all-cause hospitalization rates (measured at Year 3) (Measured as events occur during the lifespan of the trial.)

Answer: A