TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Guelph Family Health Study: Pilot Study
Brief Summary: The overall objective of the proposed study is to test, among Canadian families, the comparative effectiveness of 2 different versions (doses) of a family-based obesity prevention intervention that is tailored to families' behavioural risk profile.

To achieve this objective, we will conduct a randomized controlled trial of families with children aged 18 months- 5 years. Families will be randomized to 1 of 3 conditions: 1) Monthly emails with general health information (Attention Control), 2) Tailored weekly emails and 2 home visits with a health educator (Email +2), 3) Tailored weekly emails and 4 home visits (Email +4). The intervention will last 6 months, with follow-up at 12-months post-intervention (18 months from baseline). We will examine the impact of the intervention on the children's body composition, weight-related behaviours, and biomarkers of diabetes and cardiovascular disease risk.

We hypothesize that, compared to children in the Attention Control, children in the Email +2 and Email +4 conditions will achieve:

1. a smaller increase in adiposity (primary outcome), age- and gender-specific body mass index (BMI),over a 6-month intervention period.
2. higher frequency of family meals, child's sleep duration, physical activity, and fruit and vegetable intake and lower child's sugar-sweetened beverage intake, and sedentary behaviour over a 6-month intervention period. (secondary outcomes)
3. lower diastolic blood pressure, glycosylated hemoglobin, fasting glucose, fasting insulin, Low Density Lipoprotein (LDL) cholesterol, triglycerides, C-reactive protein, trans and saturated fats, and higher High Density Lipoprotein (HDL) cholesterol over a 6-month intervention period.

We further hypothesize that there will be no significant difference in these outcomes between children in the conditions with 2 (Email +2) or 4 (Email +4) home visits.


Options:
A: Vegetable Flavor Acceptance [Infants' Intake] (6- to 10-month-old weaned infants (3 separate test days )); Taste Liking Ratings of Vegetable Flavors [Mothers]. (Monthly, 0.5 to 4.5 months); Vegetable Flavor Acceptance (Infants' Rate of Feeding) (6- to 10-month-old weaned infants (3 separate test days))
B: Maintenance of a Child's Body Mass Index as a result of the intervention (up to two years)
C: Food intake (1 month)
D: change in adiposity (baseline, 6 month follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Guelph Family Health Study: Pilot Study
Brief Summary: The overall objective of the proposed study is to test, among Canadian families, the comparative effectiveness of 2 different versions (doses) of a family-based obesity prevention intervention that is tailored to families' behavioural risk profile.

To achieve this objective, we will conduct a randomized controlled trial of families with children aged 18 months- 5 years. Families will be randomized to 1 of 3 conditions: 1) Monthly emails with general health information (Attention Control), 2) Tailored weekly emails and 2 home visits with a health educator (Email +2), 3) Tailored weekly emails and 4 home visits (Email +4). The intervention will last 6 months, with follow-up at 12-months post-intervention (18 months from baseline). We will examine the impact of the intervention on the children's body composition, weight-related behaviours, and biomarkers of diabetes and cardiovascular disease risk.

We hypothesize that, compared to children in the Attention Control, children in the Email +2 and Email +4 conditions will achieve:

1. a smaller increase in adiposity (primary outcome), age- and gender-specific body mass index (BMI),over a 6-month intervention period.
2. higher frequency of family meals, child's sleep duration, physical activity, and fruit and vegetable intake and lower child's sugar-sweetened beverage intake, and sedentary behaviour over a 6-month intervention period. (secondary outcomes)
3. lower diastolic blood pressure, glycosylated hemoglobin, fasting glucose, fasting insulin, Low Density Lipoprotein (LDL) cholesterol, triglycerides, C-reactive protein, trans and saturated fats, and higher High Density Lipoprotein (HDL) cholesterol over a 6-month intervention period.

We further hypothesize that there will be no significant difference in these outcomes between children in the conditions with 2 (Email +2) or 4 (Email +4) home visits.


Options:
A: change in adiposity (baseline, 6 month follow-up)
B: Breastfeeding Initiation (first month after birth of child)
C: Primary Outcome Measure: BMI (6 months, 1 year, 2 year, 5 year)
D: child nutritional status (Burundi: 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Cluster Randomized Trial to Evaluate the Increase in Usage of Evidence-based Practices for Stroke Treatment Using a Multifaceted Strategy
Brief Summary: Phase 1: An observational study ( registry) will be conducted with the objective of documenting the practice of stroke treatment in brazilian and latin american hospitals.

Phase 2: A cluster randomized trial aiming to evaluate the effect of a multifaceted strategy to increase evidence based treatments usage for stroke patients. The hospitals will be randomized into two groups: the multifaceted strategy group and the usual care group.


Options:
A: Frequency of Evidence Based Strategies (Discharge or 7 days after admission); Composite Adherence Score (Discharge or 7 days after admission)
B: Appropriate treatment of malaria, pneumonia and diarrhoea in children under five years of age (1 year)
C: Proportion of eligible pregnant women who initiate ART for purposes of PMTCT (18 months)
D: Reach (Entire 6 month early or delayed implementation phase); Effectiveness - Ask (6 month early implementation phase); Effectiveness - Goal Setting (6 month early implementation phase); Effectiveness - Assistance (6 month early implementation phase); Effectiveness - Referred (6 month early implementation phase)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving the Health of South African Women With Traumatic Stress in HIV Care
Brief Summary: In this study, the investigators propose to develop Improving AIDS Care after Trauma (ImpACT), an intervention based on theories of stress and coping and evidence-based treatment for traumatic stress. The intervention will target women in South Africa who have histories of sexual trauma and are newly initiating antiretroviral therapy (ART) in order to reduce avoidant coping and traumatic stress, improve care engagement, and reduce HIV risk behaviors.


Options:
A: Self-efficacy (Change from Baseline in Self efficacy at 6 months)
B: Posttraumatic Diagnostic Scale (PDS/PSS-I). (Symptoms will be assessed at pre-treatment-point and post-treatment-point (up to 6-month follow-ups)); The Patient Health Questionnaire-9 (PHQ-9) (At pre-treatment-point, post-treatment-point, and 3- and 6-month follow-ups); The Hopkins Symptom Checklist-25 (HSCL-25) (At pre-treatment-point, post-treatment-point, and 3- and 6-month follow-ups); Perceived Stress Scale-4 (At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups)
C: Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5; Weathers et al., 2013) (Baseline, changes from baseline at 1 week post-treatment, 3 months post-treatment, and 6 months post-treatment)
D: PTSD Symptoms (90 Days, 180 days); HIV Medication Adherence (% Adherent) (180 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Evaluation of Systemic Moxifloxacin Compared to Amoxicillin Plus Metronidazole Adjunct to Non-surgical Treatment in Generalized Aggressive Periodontitis: A Randomized Clinical Trial
Brief Summary: The objective of this randomized clinical study was to evaluate the effect of systemic administration of moxifloxacin compared to amoxicillin plus metronidazole combined with non-surgical treatment in patients with generalized aggressive periodontitis (GAgP) in 6-month follow-up.

A total of 40 systemically healthy patients with GAgP will evaluate in this randomized clinical trial. Periodontal parameters (plaque index, gingival index, probing depth, bleeding on probing, clinical attachment level) will be recorded at baseline, 1st, 3rd and 6th month. Patients will receive either 400 mg moxifloxacin per os once daily or 500 mg metronidazole and 500 mg amoxicillin per os three times daily for 7 days consecutively.


Options:
A: The Primary Outcome Variable Was Probing Depth. (6-months)
B: Periodontal Attachment Level (5 years post-treatment)
C: probing depth (six months)
D: Change in probing pocket depth (PD) (baseline, 4weeks, 8weeks and 12weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Evaluation of Systemic Moxifloxacin Compared to Amoxicillin Plus Metronidazole Adjunct to Non-surgical Treatment in Generalized Aggressive Periodontitis: A Randomized Clinical Trial
Brief Summary: The objective of this randomized clinical study was to evaluate the effect of systemic administration of moxifloxacin compared to amoxicillin plus metronidazole combined with non-surgical treatment in patients with generalized aggressive periodontitis (GAgP) in 6-month follow-up.

A total of 40 systemically healthy patients with GAgP will evaluate in this randomized clinical trial. Periodontal parameters (plaque index, gingival index, probing depth, bleeding on probing, clinical attachment level) will be recorded at baseline, 1st, 3rd and 6th month. Patients will receive either 400 mg moxifloxacin per os once daily or 500 mg metronidazole and 500 mg amoxicillin per os three times daily for 7 days consecutively.


Options:
A: The Primary Outcome Variable Was Probing Depth. (6-months)
B: Change in Clinical Attachment Level (CAL) (Baseline, 3 and 6 months)
C: Percentage of sites showing attachment loss ≥ 1.3 mm over a 27.5-months period (27.5-months period (six measurements))
D: Clinical Attachment Level (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Can Early Introduction of Specialized Palliative Care Limit Intensive Care, Emergency and Hospital Admissions in Patients With Severe and Very Severe COPD? A Randomized Study
Brief Summary: Chronic obstructive pulmonary disease (COPD) is a common and, despite existing treatment options, progressive lung disease. Patients with COPD often have only limited access to palliative care. The goal of this research project is to improve the quality of life of patients with COPD.

Background In many cases, the symptoms of advanced COPD (including shortness of breath, pain and depression) are insufficiently alleviated. In addition, often in connection with an infection, patients frequently suffer from respiratory decompensation; this may lead to invasive interventions as well as the admission to the emergency room or an intensive care unit. It may ultimately lead to the death of the patient.

Aim This study aims to show that early palliative care can reduce the number of necessary invasive interventions and improve the quality of life of patients with COPD. For this purpose, a group of patients receiving early, standardized palliative care will be compared to a group of patients receiving customary treatment only, without systematic intervention by palliative care experts.

Significance The results of this study should make it possible to efficiently use the medical resources which are required for the appropriate care of patients with COPD. The goal is the best possible quality of life and better coordination of the measures taken, especially with regard to the area of acute care and the wishes of the patient.


Options:
A: Overall quality of life and psychological distress (1 year after study enrollment); Symptom control (1 year after study enrollment); Geriatric assessment outcomes as measured by OARS Instrumental Activities of Daily Living, MOS Activities of Daily Living, MOS Social Activities Limitation Scale, Hospital Anxiety and Depression Scale scores, and Karnofsky performance scale (1 year after study enrollment); Resource use as measured by chart audits (1 year after study enrollment); Identification of subgroups of patients who benefit most from the palliative care intervention in relation to sociodemographic characteristics, treatment factors, and geriatric assessment predictors at week 12 (Week 12 after study enrollment)
B: length of stay hospital, intensive care unit and emergency admissions (1 year)
C: Quality and cost of care
D: Quality of life of the patient and his family caregiver at baseline. (at baseline); Quality of life of the patient and his family caregiver at 12 weeks. (at 12 weeks); Quality of life of the patient and his family caregiver, 6-weekly after 12 weeks. (6-weekly after 12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of a Physical Activity Counseling Program Immediately After an Exacerbation in Patients With COPD.
Brief Summary: Severe exacerbations are prevalent in a subgroup of patients with COPD and generally warrant a hospitalization. During the hospitalization, patients are extremely physically inactive with only a limited recovery one month after discharge. Physical inactivity is associated with negative health benefits. Therefore intervening in the period after and exacerbation seems useful to improve the levels of physical activity. Physical activity counseling and real-time feedback have already been applied in stable patients with COPD, with beneficial effects.The present study will investigate whether this specific intervention will help to improve the activity level in patients after an acute exacerbation. Further we investigated the effects of the intervention on improvements in functional exercise capacity.


Options:
A: The benefits of resistance training during exacerbation of COPD on peripheral muscle strength during hospitalization (Will be evaluated on the second day of hospitalization, the day of hospital discharge (this time interval must be longer than five days))
B: Change in physical activity (Baseline and 12 months follow-up)
C: Change From Baseline in Inspiratory Capacity (IC) at Isotime (baseline, six weeks of treatment)
D: Improvement in physical activity (1 month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of a Physical Activity Counseling Program Immediately After an Exacerbation in Patients With COPD.
Brief Summary: Severe exacerbations are prevalent in a subgroup of patients with COPD and generally warrant a hospitalization. During the hospitalization, patients are extremely physically inactive with only a limited recovery one month after discharge. Physical inactivity is associated with negative health benefits. Therefore intervening in the period after and exacerbation seems useful to improve the levels of physical activity. Physical activity counseling and real-time feedback have already been applied in stable patients with COPD, with beneficial effects.The present study will investigate whether this specific intervention will help to improve the activity level in patients after an acute exacerbation. Further we investigated the effects of the intervention on improvements in functional exercise capacity.


Options:
A: Change in 6-minute walk test (Baseline, 8 weeks and 12 months)
B: Improvement in physical activity (1 month)
C: Number of exacerbations (12 months)
D: Exercise behavior (3 & 6 Months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Clinical Study Comparing Symbicort 'as Needed' With Pulmicort Twice Daily Plus Terbutaline 'as Needed' in Adult and Adolescent Patients With Asthma
Brief Summary: The purpose of this study is to test if Symbicort (budesonide/formoterol) Turbuhaler is effective in treating asthma when used 'as needed' in patients with milder asthma. The efficacy of Symbicort 'as needed' will be compared with Pulmicort (budesonide) Turbuhaler twice daily plus terbutaline Turbuhaler 'as needed'


Options:
A: Number of Participants Experiencing an Event in the Composite Endpoint (Asthma-related Death, Asthma-related Intubation or Asthma-related Hospitalization) (Up to 27 weeks); Number of Participants Experiencing an Event Included in the Definition of Asthma Exacerbation (Up to 26 weeks)
B: The Number of Participants With a Differential Response to the Three Step-up Therapies Based on Fixed Threshold Criteria for the Following Three Asthma Control Measures: Use of Oral Prednisone for Acute Asthma Exacerbations, Asthma Control Days and FEV1. (Measured during the last 12 weeks of each 16-week treatment period)
C: Annual Severe Asthma Exacerbation Rate - Non-inferiority Analysis (up to 52 weeks); Annual Severe Asthma Exacerbation Rate - Superiority Analysis (up to 52 weeks)
D: Evaluation of the efficacy and safety of a fixed-dose, single capsule budesonide-formoterol combination in comparison with budesonide alone in patients with uncontrolled asthma (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Clinical Study Comparing Symbicort 'as Needed' With Pulmicort Twice Daily Plus Terbutaline 'as Needed' in Adult and Adolescent Patients With Asthma
Brief Summary: The purpose of this study is to test if Symbicort (budesonide/formoterol) Turbuhaler is effective in treating asthma when used 'as needed' in patients with milder asthma. The efficacy of Symbicort 'as needed' will be compared with Pulmicort (budesonide) Turbuhaler twice daily plus terbutaline Turbuhaler 'as needed'


Options:
A: Annual Severe Asthma Exacerbation Rate - Non-inferiority Analysis (up to 52 weeks); Annual Severe Asthma Exacerbation Rate - Superiority Analysis (up to 52 weeks)
B: Evaluation of the efficacy and safety of a fixed-dose, single capsule budesonide-formoterol combination in comparison with budesonide alone in patients with uncontrolled asthma (12 weeks)
C: The primary outcome for comparison across treatment groups was the mean value of morning PEF measured during the last 2 weeks of treatment (weeks 23-24)
D: Time to first severe asthma exacerbation (At each clinic visit)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Veterans Back to Health: A Study Comparing Yoga and Education for Veterans With Chronic Low Back Pain
Brief Summary: Chronic low back pain (cLBP) is the most common pain condition in the military, causing substantial physical and psychological suffering, reduction in force readiness, and high economic cost. Yoga has been studied in 10 RCTs in civilian populations with cLBP suggesting it may be effective in reducing pain intensity, improving back-related function, and lowering pain medication use. Multiple differences exist between civilian and military populations with cLBP, making it necessary to adapt and test yoga for cLBP in military populations. This study's primary aim is to evaluate the effectiveness of yoga for reducing pain in military personnel and Veterans with cLBP through a structured, reproducible 12-week series of hatha yoga classes, supplemented with home practice, compared to an education group. Additionally, the enormous mental health burden often shouldered by returning military personnel presents another important distinguishing factor. Thus, the study's secondary aim is to assess yoga's capacity to reduce post-traumatic stress symptoms (PTSS). The third aim is to evaluate the cost-effectiveness of yoga for cLBP at 3 months and 6 months from the perspective of the provider, the Veteran, and the Veterans Health Administration. The fourth and final aim is to evaluate the effect of back pain and yoga on marital and family functioning. The proposed RCT will (1) establish a structured reproducible yoga protocol uniquely suited to Veterans populations with cLBP; (2) develop web-based delivery systems to assist Veterans in yoga home practice; (3) increase our knowledge of the feasibility and impact of yoga for Veterans' cLBP and psychological comorbidities. These results will help determine whether yoga is an effective modality for addressing cLBP in a Veteran population.


Options:
A: Change from baseline in low back pain (Baseline, 6 weeks, 12 weeks, 24 weeks); Change from baseline in back-related function (Baseline, 6 weeks, 12 weeks, 24 weeks)
B: N/A
C: Number of Days on Sick Leave (12 MONTHS)
D: Pain Scores (Baseline, Midtreatment, Posttreatment, 3 month follow-up, 6 month follow-up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Including Fitness Testing in Preventive Health Checks on Cardiorespiratory Fitness and Motivation to Change Physical Activity Behaviour
Brief Summary: The purpose of this study is to investigate if including fitness testing in preventive health checks increase cardiorespiratory fitness and motivation to change physical activity behavior compared with preventive health checks without fitness testing.


Options:
A: All cause mortality (3, 5, and 10 years)
B: The percentage of participants attending the health check compared between the groups (one-year recruitment)
C: Cardiovascular mortality (Sept 2010); MI (non fatal) (Sept 2010); Stroke (non fatal) (Sept 2010); Revascularisation (operating procedures) (Sept 2010); Amputations, non traumatic (Sept 2010)
D: Cardiorespiratory fitness (One-year follow up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Exercise Training on Cardiac Structure and Function
Brief Summary: Exercise training, as part of cardiac rehabilitation, is effective in improving functional capacity and quality of life in patients with coronary artery disease. Other cardiovascular and non-cardiovascular benefits have been reported, namely in glucose metabolism, skeletal muscle function, oxidative stress, vascular function, pulmonary circulation, ischaemia-reperfusion lesion and ventricular remodelling.

However, the benefit of exercise training on systolic and diastolic function is controversial especially after acute myocardial infarction where no longitudinal study has evaluated diastolic function using modern echocardiographic parameters.

The hypothesis is that a structured program of exercise training can improve systolic and diastolic function in patients after myocardial infarction.


Options:
A: exercise capacity as reported in total time on the exercise test using the BRUCE protocol (16 months)
B: flow mediated dilation, serum concentrations of biomarkers, restenosis-rate/ late luminal loss, heart rate variability in SDNN (6 months)
C: functional capacity at 6- and 12-months after CR in pts older than 75 years randomly allocated to Home-Based exercise program or usual care. (6 and 12 months)
D: Myocardial early diastolic velocity at mitral annulus by tissue Doppler (E' velocity) (4 months)

Answer: D