TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: DREAM-GLOBAL: Diagnosing hypeRtension - Engaging Action and Management in Getting LOwer Bp in Aboriginal and LMIC - A Research Proposal
Brief Summary: Heart disease and stroke are the number one killers world-wide. When someone has hypertension, the constantly elevated blood pressure damages their blood vessels and the organs that they supply blood to. This causes stroke, heart attack, heart failure, kidney failure and dementia. Finding and lowering high blood pressure to normal with lifestyle changes and if necessary medications, lowers the risk of these outcomes. Canada has high rates of blood pressure control compared to other countries in the world, due in large part to the successful dissemination of hypertension guidelines. However remote and disadvantaged communities have not been as successful and need additional measures to help achieve the same level of blood pressure control as the rest of the country. The DREAM-GLOBAL team has extensive experience working with Canada's Aboriginal Communities and a large community in Tanzania. The DREAM-GLOBAL project will integrate innovations in technology with the implementation of guidelines-based blood pressure control and through partnerships with experts in government and industry, overcome barriers to lowering blood pressure in Canada's Aboriginal Communities, and in a community in Tanzania. Tools will be developed and tested that will close the circle of care around people with hypertension by bringing measurement data to the medical record and health care provider and also sending useful medical feedback to the person with hypertension via secure data servers and routine SMS messaging on cell phones. The system will be tested for effectiveness of diagnosing and also for managing hypertension. To begin the process of preventing hypertension, the team will also explore with an Aboriginal community how to create policies to reduce the sodium content in their food. If proven effective, DREAM-GLOBAL can also become a platform for managing other chronic diseases.


Options:
A: Clinician Detection (probable, sub-clinical, confirmed) of major depression or generalized anxiety or post-traumatic stress disorder or alcohol dependence (Day 1); Patient discussion on mental health (Day 1)
B: Blood Pressure (one year)
C: antiretroviral treatment (primary) (6 months)
D: healing time for leg ulcer and/or diabetes related foot ulcer (one year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Medically Ill Patient Assessment of Rivaroxaban Versus Placebo in Reducing Post-Discharge Venous Thrombo-Embolism Risk
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of rivaroxaban compared with placebo in the prevention of symptomatic venous thromboembolism (VTE) events and VTE-related death post-hospital discharge in high-risk, medically ill patients.


Options:
A: Number of Participants With Grade 3 and Grade 4 Adverse Events (AEs) Through Day 35 (Up to Day 35); Number of Participants With AEs Resulting in Study Intervention Discontinuation Through Day 35 (Up to Day 35); Number of Participants With Serious Adverse Events Through Day 35 (Up to Day 35); Number of Participants Who Progressed to Moderate or Severe Disease or Higher Based on the Gates MRI Ordinal Scale Through Day 28 (Up to Day 28)
B: Time From Randomization to First Occurrence of Composite of All Symptomatic Venous Thromboembolism (VTE) and VTE Related Death Adjudicated by Clinical Event Committee (CEC) (Up to Day 45); Event Rate Based on Time From Randomization to the First Occurrence of Major Bleeding Adjudicated by CEC (From randomization to 2 days after the last dose (Day 45))
C: mortality (Until patient is discharged or up to 4 weeks whichever comes first); occurrence of venous and/or arterial thrombosis (Until patient is discharged or up to 4 weeks whichever comes first)
D: Patency after 6 months (6 months); Post-thrombotic syndrome after 2 years (yrs) (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing the Burden of Depression on Employment: Improving Function and Work
Brief Summary: The purpose of this research study is to test the effectiveness of a new telephone counseling program for employed Veterans with depression called the Veterans Work and Health Initiative (V-WHI) using the Be Well at Work (BWAW) intervention. 250 participants will be recruited and randomly assigned to one of two groups: the V-WHI experimental group or usual mental health care. The V-WHI counselors will address mental health and job-related issues that interfere with working. This counseling is provided solely over the phone with sessions every 2 weeks for 4 months (eight sessions total). At 8 months post-baseline, the V-WHI group is provided with a booster session. Participants in both groups are administered follow-up questionnaires at two time-points: month four and month nine.


Options:
A: Hamilton Depression Rating Scale (HAMD-17) (Baseline, 4, 8, 24, 36, 52 week)
B: Improvement in Work Related Disability Post Intervention (4 months post randomization)
C: Depression symptoms as assessed by the Patient Health Questionnaire-9 (PHQ-9) (10 week follow-up)
D: HAMD-17

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Thinking Healthy Program - Peer Delivered in Pakistan
Brief Summary: The rates of perinatal depression in South Asian women are reported to be amongst the highest in the world, ranging from 18%-30% in urban areas and 28%-36% in rural areas. In addition to its profound impact on women's health, disability and functioning, perinatal depression is associated with poor child health outcomes such as pre-term birth, infant under-nutrition and stunting. There is robust evidence that perinatal depression can be effectively managed with psychological treatments delivered by non-specialist health care workers. Our previous research conducted in Pakistan led to the development of the Thinking Healthy Program (THP). THP is a psychological treatment delivered by community health workers (CHWs) which more than halved the rate of perinatal depression among mothers and led to significant improvements in child health outcomes. To enhance access to such evidence-based psychological treatments, there is a need to examine the potential role of other human resources such as lay persons in delivering psychological treatments such as THP in poor resource settings.


Options:
A: physical violence (Assessed at 10-week follow-up)
B: Changes in thyroid morphology and thyroid function tests in morbidly obese patients following significant weight loss after bariatric surgery (> 3 month or when relevant weight loss has been achieved)
C: Remission (i.e. recovery from depression) (6 months post child birth)
D: Baby's health status (6 days after birth; 6 months after birth; 12 months after birth)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Thinking Healthy Program - Peer Delivered in Pakistan
Brief Summary: The rates of perinatal depression in South Asian women are reported to be amongst the highest in the world, ranging from 18%-30% in urban areas and 28%-36% in rural areas. In addition to its profound impact on women's health, disability and functioning, perinatal depression is associated with poor child health outcomes such as pre-term birth, infant under-nutrition and stunting. There is robust evidence that perinatal depression can be effectively managed with psychological treatments delivered by non-specialist health care workers. Our previous research conducted in Pakistan led to the development of the Thinking Healthy Program (THP). THP is a psychological treatment delivered by community health workers (CHWs) which more than halved the rate of perinatal depression among mothers and led to significant improvements in child health outcomes. To enhance access to such evidence-based psychological treatments, there is a need to examine the potential role of other human resources such as lay persons in delivering psychological treatments such as THP in poor resource settings.


Options:
A: Remission (i.e. recovery from depression) (6 months post child birth)
B: Score Difference in Symptoms of Anxiety, Depression and Post-traumatic Stress Disorders. (Within the fifteen (15) days after finishing the intervention, either Common Elements Treatment Approach (CETA) or Narrative Community Group Therapy (NCGT). In the control group, 12 weeks after the baseline assessment.)
C: Self-Reporting Questionnaire 20 (SRQ-20) (Two months)
D: Severity of Trauma. This will be the difference in group mean score of severity of depression based on a sum of ratings of various standard depression symptoms from the Hopkins Symptom Checklist and locally defined symptoms. (After 12 counseling , 4-5 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Patient-centered Care Transitions in Heart Failure: A Pragmatic Cluster
Brief Summary: Heart failure (HF) is the most common cause of hospitalization in older adults. The month after hospital discharge represents a vulnerable period, when patients are at increased risk of death and readmission to hospital. Research has shown that certain discharge-planning services can reduce death and readmissions, but these have not been widely implemented. In this study, we will group evidence-informed discharge-planning services into 'Patient-centered Care Transitions in HF' (PACT-HF), a model of care that will prepare patients for their transition from hospital to home. Through PACT-HF, patients will benefit from a comprehensive assessment of their health care needs, learn to recognize and manage symptoms of HF, and receive the information and follow-up care needed to optimize their health. We will introduce PACT-HF to 10 Ontario hospitals over a number of time periods using a stepped wedge cluster trial design. We will compare the outcomes (hierarchically ordered) of patients in hospitals with PACT-HF to those in hospitals without PACT-HF. We anticipate that patients hospitalized at the sites with PACT-HF will have fewer readmissions, emergency visits, and deaths after discharge; report a better quality of life; and feel more prepared for discharge. We also anticipate that overall, PACT-HF will reduce health system costs.


Options:
A: Quality of life (At inclusion (baseline), change from baseline at 3, 6 and 12 months)
B: Time to composite all-cause readmissions/emergency department (ED) visits/death at 3 months (Within 3 months of hospital discharge); Time to composite all-cause readmissions/emergency department (ED) visits/death at 30 days (Within 30 days of hospital discharge)
C: CR Program Adherence (6 months)
D: Change in Chronic Heart Failure Health Status Between Baseline and 12 Months. (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Patient-centered Care Transitions in Heart Failure: A Pragmatic Cluster
Brief Summary: Heart failure (HF) is the most common cause of hospitalization in older adults. The month after hospital discharge represents a vulnerable period, when patients are at increased risk of death and readmission to hospital. Research has shown that certain discharge-planning services can reduce death and readmissions, but these have not been widely implemented. In this study, we will group evidence-informed discharge-planning services into 'Patient-centered Care Transitions in HF' (PACT-HF), a model of care that will prepare patients for their transition from hospital to home. Through PACT-HF, patients will benefit from a comprehensive assessment of their health care needs, learn to recognize and manage symptoms of HF, and receive the information and follow-up care needed to optimize their health. We will introduce PACT-HF to 10 Ontario hospitals over a number of time periods using a stepped wedge cluster trial design. We will compare the outcomes (hierarchically ordered) of patients in hospitals with PACT-HF to those in hospitals without PACT-HF. We anticipate that patients hospitalized at the sites with PACT-HF will have fewer readmissions, emergency visits, and deaths after discharge; report a better quality of life; and feel more prepared for discharge. We also anticipate that overall, PACT-HF will reduce health system costs.


Options:
A: Combined Emergency Department Visits and Inpatient Readmissions (30 days after discharge from hospital); Combined Emergency Department Visits and Inpatient Readmissions (90 days after discharge from hospital); Combined Emergency Department Visits and Inpatient Readmissions (180 days after discharge from hospital)
B: Hospital readmission rate (all cause) (90 days)
C: Time to composite all-cause readmissions/emergency department (ED) visits/death at 3 months (Within 3 months of hospital discharge); Time to composite all-cause readmissions/emergency department (ED) visits/death at 30 days (Within 30 days of hospital discharge)
D: Any Hospital Readmission (180-day from indexed hospital discharge)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Multi Center, Study to Evaluate the Safety and Efficacy of the VasQ External Support Device for Brachiocephalic Arteriovenous Fistula
Brief Summary: This study is a prospective, multi center, randomized, controlled study of the VasQ in arteriovenous fistulas. The VasQ constraints and directs the geometrical parameters of the fistula as well as the vascular diameter and gradient in the vicinity of the AV shunt. These geometrical constraints direct flow and influence hemodynamics, and hence minimize turbulence and promote laminar flow. The device is designed to improve short term maturation and long term patency of the fistula. The VasQ is a permanent implant intended for use as a subcutaneous arteriovenous conduit support for vascular access.


Options:
A: N/A
B: Time to AVF Primary Unassisted Patency (Days from AVF creation until the first occurrence of either access thrombosis or procedure to restore or maintain patency, assessed up to 1 year); Kaplan-Meier Estimate of Secondary AVF Patency (Median time from AVF creation until AVF abandonment (secondary patency), assessed up to 1 year)
C: Change to diameter of vein (Initial assessment and 6 weeks after surgery)
D: Primary safety endpoint: Freedom from severe (i.e. performance of daily activities is compromised) or unanticipated device related adverse events (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Can Vitamin D Supplementation Prevent Food Allergy in Infants? the VITALITY Trial
Brief Summary: We report that Australia has the highest prevalence of Immunoglobulin(Ig)E-mediated food allergy in the world, with 10% of infants having challenge-proven food allergy in Melbourne. There has been a 5-fold increase in hospital admissions for life-threatening anaphylaxis. These changes are most pronounced in children less than 5 years, suggesting a causal role for early life determinants. We have primary data to inform hypotheses for the rise in food allergy, which appears to result from potentially modifiable factors related to the modern lifestyle, particularly Vitamin D insufficiency (VDI). We propose an intervention study to assess if infant Vitamin D supplementation during the first year of life significantly decreases the risk of early-onset food allergy and other allergic disease at 12 months (part 1) and 6 years of age (part 2). Australia is ideally placed to answer this important question since, unlike the USA, Canada and Europe, there are no population recommendations for routine infant supplementation with Vitamin D and we are one of the few developed countries that do not supplement the food chain supply with Vitamin D.


Options:
A: Serum interleukin-6 (At trial entry and 7 days after daily vitamin D supplementation therapy); Serum tumor necrosis-alpha (At trial entry and 7 days after daily vitamin D supplementation therapy)
B: The prevalence of challenge-proven food allergy at 12 months of age (At 12 months of age); The occurrence of definite food allergy or tolerance at 6 years of age (At 6 years of age)
C: serum 25-hydroxyvitamin D concentration, (3 time poits up to 6 months (0-3-6 months))
D: Number of Infants With Recurrent Wheezing (up to 12 months adjusted age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Can Vitamin D Supplementation Prevent Food Allergy in Infants? the VITALITY Trial
Brief Summary: We report that Australia has the highest prevalence of Immunoglobulin(Ig)E-mediated food allergy in the world, with 10% of infants having challenge-proven food allergy in Melbourne. There has been a 5-fold increase in hospital admissions for life-threatening anaphylaxis. These changes are most pronounced in children less than 5 years, suggesting a causal role for early life determinants. We have primary data to inform hypotheses for the rise in food allergy, which appears to result from potentially modifiable factors related to the modern lifestyle, particularly Vitamin D insufficiency (VDI). We propose an intervention study to assess if infant Vitamin D supplementation during the first year of life significantly decreases the risk of early-onset food allergy and other allergic disease at 12 months (part 1) and 6 years of age (part 2). Australia is ideally placed to answer this important question since, unlike the USA, Canada and Europe, there are no population recommendations for routine infant supplementation with Vitamin D and we are one of the few developed countries that do not supplement the food chain supply with Vitamin D.


Options:
A: SCORAD score (May - August 2012 (3 months))
B: Mean Annual Rate of Respiratory Events (Up to 2 years)
C: Serum 25-Hydroxyvitamin D [25(OH)D] Levels (30 days)
D: The prevalence of challenge-proven food allergy at 12 months of age (At 12 months of age); The occurrence of definite food allergy or tolerance at 6 years of age (At 6 years of age)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of the Effectiveness of a Nurse-led Self-efficacy Enhancing Stroke Self-management Program for Community-dwelling Stroke Survivors
Brief Summary: The aim of this study is to examine the effectiveness of a nurse-led self-efficacy enhancing stroke self-management program on recovery of community-dwelling stroke survivors.


Options:
A: Self-efficacy in performing stroke self-management behaviors (One month after the program)
B: Stroke Specific Health Related Quality of Life (6 months for (SSQoL) and 3 months for Perceived Energy Subdomain); Self-Efficacy to Manage Stroke Symptoms (6 months)
C: blood pressure (12 months)
D: Rate of recruitment to the studies (12 weeks (pilot study))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Various Oral Hygiene Procedures on the Reduction of Oral Malodor in Periodontally Healthy Patients
Brief Summary: The purpose of the study is to evaluate the effect of various oral hygiene procedures on reduction of oral malodor.


Options:
A: Periodontal Pocket Depth (PPD) (30 day.)
B: Oral malodor (7 days)
C: Oral malodor was evaluated at before rinsing, right after rinsing and follows up every 30 minutes till 4 hours with organoleptic measurements. (4 hours)
D: Volatile sulfur compounds (VSCs) (5 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Eosinophilic Esophagitis With Mometason Furoat Aerosol: a Randomised, Placebo-controled Phase II Study for Evaluation of Treatment Effect on Group Level Including Symtom Questionnaires
Brief Summary: Background:

Eosinophilic esophagitis ( EoE ) is a disease entity which has been properly recognized only within the past two decades.(1) A prevalence of nearly 1% means that almost 20,000 people in the Region of Western Sweden may be affected.(2 ) The main symptom is swallowing difficulty and food may be stuck, which typically require acute hospital care with operational action under general anesthesia.( 3,4 ) The standard treatment today is local treatment with steroids by mouth several times a day for a few weeks.( 5 ) In adults and large teenagers, there is only one randomized study which has shown that budesonide has a significant effect exaggerating that of placebo. However, the main end-point in this study was the degree of tissue inflammation.(6) In a separate study using validated questionnaires , we have shown that patients with EoE have distinct organ-specific symptoms and a lowered quality of life . These symptoms nearly disappeared, after treatment with mometasone furoate. However, as that study was not randomized or placebo controlled no causal conclusions could be drawn regarding the treatment effect, but the method of validated questionnaires proved sensitive to changes in symptomatology.(7) Purpose The primary purpose of this study is to evaluate the effect of local steroid treatment with mometasone furoate on swallowing problems in patients with EoE . Secondarily, to evaluate the effect on patient quality of life and the presence of side effects.


Options:
A: Proportion of Participants Who Had Relapse During the Entire Week 36 Period (Week 36)
B: Percent of Participants Who Were Histologic Responders (Week 16); Change From Baseline in The Dysphagia Symptom Questionnaire (DSQ) Score at The Final Treatment Period Evaluation (Baseline, Week 16)
C: Percent of Participants Who Responded to Therapy (12 weeks after the start of treatment)
D: Watson Dysphagia Scale Score (WDS) (Two months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Creating Health and Safety Communities of Practice for Home Care Workers
Brief Summary: The current project is a safety and health intervention for home care workers conducted within the Oregon Healthy Workforce Center (OHWC), a NIOSH Center of Excellence in Total Worker Health.

The objective of this five-year project is to create sustainable health and safety "communities of practice" within a population of typically isolated home care workers. The intervention is a team-based, peer-led scripted curriculum that integrates health promotion and protection topics, as well as proven elements of social support groups for caregivers. The investigators hypothesize that this intervention will increase measures of experienced community of practice, well-being, and diet, exercise, and safety behaviors, as compared to a usual practices control condition.


Options:
A: Biochemically verified smoking cessation rates at 6 months post-quit date
B: Quit Rate (30-day Follow-Up); Quit Rate (6-Month Follow-Up)
C: Physical Activity (Measured 5 times over 13 months, for seven days each time. Time points = baseline, 1-2weeks, 3 months, 6 months and 12 months)
D: Change from baseline in experienced community of practice at 6 and 12 months. Post intervention maintenance from 12 to 24 months. (Baseline, 6 months, 12 months, 24 months); Change from baseline in well-being at 6 and 12 months. Post intervention maintenance from 12 to 24 months. (Baseline, 6 months, 12 months, 24 months); Change from baseline in dietary behaviors at 6 and 12 months. Post intervention maintenance from 12 to 24 months. (Baseline, 6 months, 12 months, 24 months); Change from baseline in exercise behaviors at 6 and 12 months. Post intervention maintenance from 12 to 24 months. (Baseline, 6 months, 12 months, 24 months); Change from baseline in safety behavior counts at 6 and 12 months, Post intervention maintenance from 12 to 24 months. (Baseline, 6 months, 12 months, 24 months); Change from baseline safety behavior consistency at 6 and 12 months, Post intervention maintenance from 12 to 24 months. (Baseline, 6 months, 12 months, 24 months)

Answer: D