TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Daily Whole-Body Vibration on Tibial Trabecular Bone Mineral Density in Osteopenic Postmenopausal Women
Brief Summary: This study will examine whether whole-body vibration slows down bone loss in healthy postmenopausal women with osteopenia. Whole-body vibration is a promising novel therapy that involves standing on a platform which produces extremely small and fast up-and-down movements. Some but not all research studies have found that whole-body vibration slowed down bone loss in postmenopausal women. One of the reasons why different studies found different results may be because they used various speeds of vibration. This study looks at how different speeds of whole-body vibration influence bone mineral density differently in postmenopausal women who have osteopenia. Two hundred postmenopausal women will take part in this 12-month study. Women will be randomly assigned into three groups (67 women per group) and these groups will be compared. Group 1 will receive very fast whole-body vibration, Group 2 will receive fast whole-body vibration, and Group 3 will not receive whole-body vibration. We will look at various bone mineral density and bone quality measurements, obtained with three different types of technologies, at the beginning of the study and at 12 months of follow-up. The hypothesis of this study is that the in comparison to Group 3 (no vibration), Groups 1 and 2 will experience reduced bone loss over 12 months, and that the greatest reduction in bone loss will be experienced by Group 1. The results of this study will help us determine whether whole-body vibration at different speeds produces variable effects on bone, hence explaining the inconsistency of the results obtained in previous studies.


Options:
A: Change in body weight (Baseline and at 16 weeks)
B: C peptide
C: Trabecul volumetric bone mineral density (BMD) of the lower tibia (using peripheral quantitative computed tomography; pQCT)) (Baseline and 12 months)
D: fractures (4 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Lifestyle Change and Quality of Life in Obese Endometrial Cancer Survivors
Brief Summary: RATIONALE: Exercise and dietary counseling may affect weight loss and improve the quality of life of obese endometrial cancer patients and may help them live longer and more comfortably.

PURPOSE: This randomized clinical trial is studying the effects of exercise and dietary counseling on weight loss and quality of life of obese patients with stage I or stage II endometrial cancer in remission.


Options:
A: change in fasting glucose (12 weeks); change in fasting insulin (12 weeks); change in fasting beta-hydroxybutyrate (12 weeks)
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: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Lifestyle Change and Quality of Life in Obese Endometrial Cancer Survivors
Brief Summary: RATIONALE: Exercise and dietary counseling may affect weight loss and improve the quality of life of obese endometrial cancer patients and may help them live longer and more comfortably.

PURPOSE: This randomized clinical trial is studying the effects of exercise and dietary counseling on weight loss and quality of life of obese patients with stage I or stage II endometrial cancer in remission.


Options:
A: Change from Baseline in Body Composition (At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis)
B: Weight loss maintenance (6 - 18 months)
C: Changes from Baseline in Exercise, Diet, and Posttraumatic Growth Inventory(PTGI) (baseline, 3month, 6month, and 12month)
D: 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)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Lifestyle Change and Quality of Life in Obese Endometrial Cancer Survivors
Brief Summary: RATIONALE: Exercise and dietary counseling may affect weight loss and improve the quality of life of obese endometrial cancer patients and may help them live longer and more comfortably.

PURPOSE: This randomized clinical trial is studying the effects of exercise and dietary counseling on weight loss and quality of life of obese patients with stage I or stage II endometrial cancer in remission.


Options:
A: Weight loss (2 years)
B: 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)
C: Weight loss (2 years)
D: Recruitment Rate (Percentage of Potentially Eligible Participants Who Were Enrolled to the Study) (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 6-Month, Phase IIIA, Multi-Center,Randomised,Double-Blind, Double-Dummy, Parallel-Group Study of the Efficacy and Safety of Symbicort® Turbuhaler®+ Bricasol® pMDI Compared With Pulmicort® Turbuhaler®+Bricasol® pMDI in Chinese Patients With COPD
Brief Summary: This study aims at evaluating efficacy and safety of Symbicort® Turbuhaler® in Chinese COPD patients as defined by GOLD treatment guidelines in order to obtain an approval for indication of COPD from Chinese State Food and Drug Administration.


Options:
A: Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) (Baseline to Endpoint (13 weeks)); Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1 (Baseline to Endpoint (13 weeks))
B: Post-study medication FEV1 (1 hour after medication)
C: Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) (Baseline to Endpoint (13 weeks)); Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1 (Baseline to Endpoint (13 weeks))
D: Inflammation: localisation, numbers and profile of neutrophils, eosinophils, macrophages, and CD8+T cells in bronchial biopsy specimens after 6 months and 2.5 years treatment.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 6-Month, Phase IIIA, Multi-Center,Randomised,Double-Blind, Double-Dummy, Parallel-Group Study of the Efficacy and Safety of Symbicort® Turbuhaler®+ Bricasol® pMDI Compared With Pulmicort® Turbuhaler®+Bricasol® pMDI in Chinese Patients With COPD
Brief Summary: This study aims at evaluating efficacy and safety of Symbicort® Turbuhaler® in Chinese COPD patients as defined by GOLD treatment guidelines in order to obtain an approval for indication of COPD from Chinese State Food and Drug Administration.


Options:
A: Post-study medication FEV1 (1 hour after medication)
B: The primary efficacy endpoint is defined as area under the curve of change in FEV1 from baseline for the time period from pre-dose to 2 hours post dose (AUC0 2hFEV1) after 12 weeks of randomised treatment. (week 12)
C: Trough FEV1 (L) at 28 Weeks on Treatment (Week 28); Trough Forced Expiratory Volume in the First Second (FEV1) (L) at 12 Weeks on Treatment (Week 12)
D: Annual Rate of Moderate and Severe COPD Exacerbations Expressed as Least Square Mean (From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 6-Month, Phase IIIA, Multi-Center,Randomised,Double-Blind, Double-Dummy, Parallel-Group Study of the Efficacy and Safety of Symbicort® Turbuhaler®+ Bricasol® pMDI Compared With Pulmicort® Turbuhaler®+Bricasol® pMDI in Chinese Patients With COPD
Brief Summary: This study aims at evaluating efficacy and safety of Symbicort® Turbuhaler® in Chinese COPD patients as defined by GOLD treatment guidelines in order to obtain an approval for indication of COPD from Chinese State Food and Drug Administration.


Options:
A: Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) (Baseline to Endpoint (13 weeks)); Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1 (Baseline to Endpoint (13 weeks))
B: Pre-dose and 1-hour post-dose FEV1 over the 12 months treatment period
C: Post-study medication FEV1 (1 hour after medication)
D: Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) (Baseline to Endpoint (13 weeks)); Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1 (Baseline to Endpoint (13 weeks))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: A lack of public awareness about entitled health and social services may contribute to poor delivery of services in developing countries. We sought to determine the impact of educating villagers about entitled services.


Options:
A: Change in Infant immunization status; Change in Infant well child care status
B: visits by nurse midwife; prenatal exams, tetanus vaccinations, & iron tablets received by pregnant women; infant vaccinations; educational scholarships and fees for children; occurrence of village council meetings; development work in villages
C: EPI vaccines and other health interventions coverage (1 year); Molecular makers of resistance of P. falciparum to Sulfaxodine- pyrimethamine (1 year)
D: seasonal influenza vaccination (up to 4 months following reminder notification)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: A lack of public awareness about entitled health and social services may contribute to poor delivery of services in developing countries. We sought to determine the impact of educating villagers about entitled services.


Options:
A: EPI vaccines and other health interventions coverage (1 year); Molecular makers of resistance of P. falciparum to Sulfaxodine- pyrimethamine (1 year)
B: Exhaled Carbon Monoxide Levels (1 month)
C: visits by nurse midwife; prenatal exams, tetanus vaccinations, & iron tablets received by pregnant women; infant vaccinations; educational scholarships and fees for children; occurrence of village council meetings; development work in villages
D: The primary outcome will measure the number of children who got vaccinated for routine immunization scheduled at 6, 10 and 14 weeks of life (Vaccination status at 20th week of life of the particpants)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: A lack of public awareness about entitled health and social services may contribute to poor delivery of services in developing countries. We sought to determine the impact of educating villagers about entitled services.


Options:
A: Proportion of Children Under 5 Years in Vulnerable Households That Have a Birth Certificate (1 year); Proportion of Children Under 5 Years in Vulnerable Households That Have Up-to-date Vaccinations (1 year); Proportion of Children Aged 6-12 Years That Attended Primary School 80% of Days in the Last Month (1 year)
B: visits by nurse midwife; prenatal exams, tetanus vaccinations, & iron tablets received by pregnant women; infant vaccinations; educational scholarships and fees for children; occurrence of village council meetings; development work in villages
C: EPI vaccines and other health interventions coverage (1 year); Molecular makers of resistance of P. falciparum to Sulfaxodine- pyrimethamine (1 year)
D: Completion of 3 Doses of Pentavalent Vaccine (8 months of age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Endovascular Versus Transabdominal Treatment of the Abdominal Aortic Aneurysm: the Dutch Randomised Endovascular Aneurysm Management (DREAM-) Trial
Brief Summary: The purpose of this trial is to assess whether the new endovascular repair technique of the abdominal aortic aneurysm (AAA) is an adequate substitute of the conventional AAA repair.


Options:
A: combined operative mortality and morbidity (5-8 years)
B: Number of Subjects That Experienced Rupture or Aneurysm Related Death (3 years)
C: all cause mortality at 3 years (3 years)
D: All-cause Mortality (Participants were followed for the duration of the study, up to 9 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Endovascular Versus Transabdominal Treatment of the Abdominal Aortic Aneurysm: the Dutch Randomised Endovascular Aneurysm Management (DREAM-) Trial
Brief Summary: The purpose of this trial is to assess whether the new endovascular repair technique of the abdominal aortic aneurysm (AAA) is an adequate substitute of the conventional AAA repair.


Options:
A: combined operative mortality and morbidity (5-8 years)
B: Death and major adverse events (4 years)
C: All-cause Mortality (Participants were followed for the duration of the study, up to 9 years)
D: all cause mortality at 3 years (3 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Endovascular Versus Transabdominal Treatment of the Abdominal Aortic Aneurysm: the Dutch Randomised Endovascular Aneurysm Management (DREAM-) Trial
Brief Summary: The purpose of this trial is to assess whether the new endovascular repair technique of the abdominal aortic aneurysm (AAA) is an adequate substitute of the conventional AAA repair.


Options:
A: Mortality at 30 days after the treatment(endovascular repair versus conventional repair) (30 days after the treatment)
B: all cause mortality at 3 years (3 years)
C: All-cause Mortality (Participants were followed for the duration of the study, up to 9 years)
D: combined operative mortality and morbidity (5-8 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Endovascular Versus Transabdominal Treatment of the Abdominal Aortic Aneurysm: the Dutch Randomised Endovascular Aneurysm Management (DREAM-) Trial
Brief Summary: The purpose of this trial is to assess whether the new endovascular repair technique of the abdominal aortic aneurysm (AAA) is an adequate substitute of the conventional AAA repair.


Options:
A: Number of Subjects That Experienced Rupture or Aneurysm Related Death (3 years)
B: all cause mortality at 3 years (3 years)
C: combined operative mortality and morbidity (5-8 years)
D: All-cause Mortality (Participants were followed for the duration of the study, up to 9 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled, Parallel Group, Single Blinded, Phase 1 Study That Investigates the Effects of Regular Daily Intake of Small Amounts of Dark or White Chocolate on Blood Pressure in Elderly Individuals With Mild Hypertension
Brief Summary: Regular intake of cocoa-containing foods is linked to a considerably lower cardiovascular and all-cause mortality in observational studies. Short-term intervention studies indicate that high doses of cocoa improve endothelial function and reduce blood pressure (BP), but the clinical impact of long-term intake of small dietary amounts of cocoa on BP and the underlying BP lowering mechanisms are unclear. We hypothesized that cocoa consumption lowers blood pressure by augmentation of the circulating vasodilative nitric oxide (NO) pool due to the action of the cocoa polyphenols at the vascular endothelium.

To test this hypothesis, we will conduct a randomized single-blind, parallel group study in subjects with mild essential hypertension to evaluate the effects of polyphenol-rich dark chocolate versus polyphenol-free white chocolate on blood pressure and plasma levels of cocoa phenols, circulating bioactive nitric oxide, and plasma markers of oxidative stress. After a 7 day cocoa-free run-in period, 44 subjects will be 1:1 randomized to receive over 18 weeks daily doses of either dark chocolate (6.3 g per day with a total of 30 mg of polyphenols and 30 kcal) or polyphenol free white chocolate (5.6 g per day with 30 kcal, containing similar amounts of macronutrients, electrolytes and vitamins). Subjects will be counseled to maintain an isocaloric diet and to abstain from other cocoa products during the study. Blood pressure and plasma parameters will be assessed in each subject after the run-in period and after 6, 12, and 18 weeks of treatment.


Options:
A: An improvement of endothelial function as measured by flow-mediated dilation (FMD) (1 month)
B: changes in systolic and diastolic blood pressure
C: N/A
D: Vascular function (Measured at weeks 4 and 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Contention Alone Versus Anticoagulation for Symptomatic Calf Vein Thrombosis Diagnosed by Ultrasonography
Brief Summary: CACTUS-PTS is a randomized, placebo-controlled, double-blind study which aims primarily to determine the effectiveness of a 6 week course of therapeutic-dose LMWH (nadroparine) injections vs. placebo in patients with a first symptomatic isolated distal (calf) deep-vein thrombosis (IDDVT), as measured by rate of proximal DVT and symptomatic PE at 6 weeks. Additionally, the study aims to determine if the 6 week course of treatment with therapeutic-dose LMWH (nadroparine) injections, compared to placebo, decreases the frequency of post-thrombotic syndrome (PTS) at 1 year.


Options:
A: Patency after 6 months (6 months); Post-thrombotic syndrome after 2 years (yrs) (2 years)
B: Improvement of Total EKOS Thrombus Score, a specifically developed venographic scoring system (After 15 hours of CDT)
C: Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale) (Between 6 and 24 months after randomization)
D: Composite of rate of extension of distal DVT to proximal deep veins (includes ipsilateral extension or new contralateral proximal DVT) or symptomatic PE at 6 weeks (6 weeks); Rate of post-thrombotic syndrome (PTS) (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Trial Assessing the Efficacy and Safety of Grazax in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis With or Without Asthma
Brief Summary: The trial is performed to evaluate the efficacy and safety of specific immunotherapy with Grazax for treatment of grass pollen induced allergy.


Options:
A: change in symptom score active versus placebo
B: Average Adjusted Symptom Score (Year 2 of treatment)
C: determine the proportion of patients who achieve well-controlled asthma with SLIT compared to placebo (September 2009)
D: Recording of allergy symptoms (Grass pollen season 2007)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Trial Assessing the Efficacy and Safety of Grazax in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis With or Without Asthma
Brief Summary: The trial is performed to evaluate the efficacy and safety of specific immunotherapy with Grazax for treatment of grass pollen induced allergy.


Options:
A: Average Adjusted Symptom Score (Year 2 of treatment)
B: Pharmacodynamics - Immunological assessments (Pre- and post treatment)
C: Combined Score (CS) (Pollen period (average of 42.8 days))
D: Recording of allergy symptoms (Grass pollen season 2007)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Trial of Zinc and Micronutrients in Tanzanian Children
Brief Summary: A randomized clinical trial of multiple micronutrients, zinc, zinc + micronutrients, or placebo among 2400 children born to HIV-negative Tanzanian mothers.


Options:
A: Infant neurodevelopment (9 Month of infant age)
B: Change in concentrations of biomarkers of vitamin B12 in mother-child pairs (Baseline and 6 months postpartum); Vaccine specific immunity in infants (6 months); Cognitive, Language and Motor Composite Score (12 months); Nuroinflammatory cytokines (12 months)
C: Number of episodes diarrhea (all, severe, prolonged) and pneumonia (ALRI, Clinical pneumonia) (6 months); Prevalence of diarrhea (6 months)
D: Incidence of diarrhea (from ages 6 weeks to 18 months); respiratory tract infections (from ages 6 weeks to 18 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Trial of Zinc and Micronutrients in Tanzanian Children
Brief Summary: A randomized clinical trial of multiple micronutrients, zinc, zinc + micronutrients, or placebo among 2400 children born to HIV-negative Tanzanian mothers.


Options:
A: Death among children 1-36 months of age
B: Incidence of diarrhea (from ages 6 weeks to 18 months); respiratory tract infections (from ages 6 weeks to 18 months)
C: IQ score (Aug 2007-Jan 2008)
D: Linear growth velocity (6 to 18 months of age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Trial of Zinc and Micronutrients in Tanzanian Children
Brief Summary: A randomized clinical trial of multiple micronutrients, zinc, zinc + micronutrients, or placebo among 2400 children born to HIV-negative Tanzanian mothers.


Options:
A: Incidence of diarrhea (from ages 6 weeks to 18 months); respiratory tract infections (from ages 6 weeks to 18 months)
B: cognitive development(visual attention, executive processing, vigilance) (6, 9, 12, and 18 months)
C: All-cause mortality and diarrheal morbidity (age 6 weeks to age 24 months)
D: Number of episodes diarrhea (all, severe, prolonged) and pneumonia (ALRI, Clinical pneumonia) (6 months); Prevalence of diarrhea (6 months)

Answer: A