TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Preoperative Methylprednisolone to Patients Suspected of Appendicitis Undergoing Laparoscopy
Brief Summary: To test whether 125 mg preoperative methylprednisolone intravenously can reduce postoperative pain after laparoscopy for suspected appendicitis and to test whether preoperative methylprednisolone can reduce postoperative fatigue, increase quality of sleep, reduce nausea or vomiting, reduce duration of convalescence and increase overall quality of recovery after laparoscopy for suspected appendicitis.


Options:
A: Incidence or intensity of PONV (during postoperative hospital stays (2 days))
B: Pain at rest during the first 3 postoperative days on a 11-point NRS (6 hours, 12 hours, postoperative day (POD) 1, POD2 and POD3)
C: Nausea (0-72 hours postoperative)
D: Cumulative 24 Hour Oral Morphine Equivalent Consumption (24 hours (Day 1))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Managing Adolescent Obesity at Local Level by Combining Primary and Secondary Intervention
Brief Summary: The objective of the project is to develop, implement and evaluate a prevention program for obesity among adolescents in Brazil combining the primary care health system implemented in the country in recent decades with primary prevention at schools.


Options:
A: BMI z score (24 months (end of intervention)); BMI z score (60 months of age (followup at 5 years of age)); BMI z score (Follow-up at 11 years of age)
B: Body Mass Index (BMI)-for-age percentile (one year)
C: Body Mass Index (one year)
D: Overweight and obesity according to IOTF references (0-1-2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Stroke Prevention Rehabilitation Intervention Trial of Exercise - SPRITE - A Feasibility and Pilot Study
Brief Summary: BACKGROUND - Approximately 1,700 transient ischaemic attacks (TIAs) occur annually in NI with TIA survivors often being left with considerable functional impairment. TIA and strokes share common risk factors with cardiovascular disease. Cardiac rehabilitation post-myocardial infarction has shown significant reductions in morbidity and mortality, with home-based programmes producing better adherence and similar outcomes to hospital-and community-based programmes. However, the value of rehabilitation programmes for stroke prevention following a TIA or minor stroke is unclear.

AIMS - to determine if a novel rehabilitation programme, 'The Healthy Brain Rehabilitation Manual', for TIA/minor stroke patients can be developed, using MRC guidelines for developing complex health service interventions, from an approved home-based cardiac rehabilitation programme (the 'Heart Manual') and to undertake feasibility and pilot studies of the novel programme.

METHODS-All patients attending a TIA clinic in Belfast within 4 weeks of their first TIA/mild stroke will be invited to participate. The novel home-based programme manual will be developed following systematic reviews of the literature and qualitative exploration with the target population, using focus groups. A feasibility study will initially be undertaken lasting 6 weeks and then developed into a pilot trial of 12 weeks duration. The feasibility will recruit to 3 different treatments: (1) standard care; (2) standard care plus the manual; (3) standard care, manual plus a pedometer. Whilst for the pilot study there will also be 3 arms but this will include: 1) control group; 2) manual and pedometer supported by telephone follow-up with a GP; 3) manual and pedometer supported by telephone follow-up with a stroke nurse. Interviews and focus groups will be employed to assess the interventions' acceptability. The intervention, 'The Healthy Brain Rehabilitation Manual' will be refined and modified at all stages of the research.

CONCLUSIONS - The findings will inform the development of a novel secondary prevention programme, 'The Healthy Brain Rehabilitation Manual', for TIA/minor stroke patients and of a trial to test its effectiveness and longer-term potential to improve outcomes for TIA/stroke patients.


Options:
A: Difference in physical activity scale for the elderly (24 months)
B: blood pressure (12 months)
C: Rate of recruitment to the studies (12 weeks (pilot study))
D: Depressive symptoms: Patient Health Questionnaire Depression Scale (PHQ-9) (Change in depressive symptoms from baseline to 8 weeks); Caregiving-related negative life changes: Bakas Caregiving Outcomes Scale (BCOS) (Change in caregiving-related negative life changes from baseline to 8 weeks); Unhealthy days: Unhealthy Days (UD) (Change in unhealthy days from baseline to 8 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Stroke Prevention Rehabilitation Intervention Trial of Exercise - SPRITE - A Feasibility and Pilot Study
Brief Summary: BACKGROUND - Approximately 1,700 transient ischaemic attacks (TIAs) occur annually in NI with TIA survivors often being left with considerable functional impairment. TIA and strokes share common risk factors with cardiovascular disease. Cardiac rehabilitation post-myocardial infarction has shown significant reductions in morbidity and mortality, with home-based programmes producing better adherence and similar outcomes to hospital-and community-based programmes. However, the value of rehabilitation programmes for stroke prevention following a TIA or minor stroke is unclear.

AIMS - to determine if a novel rehabilitation programme, 'The Healthy Brain Rehabilitation Manual', for TIA/minor stroke patients can be developed, using MRC guidelines for developing complex health service interventions, from an approved home-based cardiac rehabilitation programme (the 'Heart Manual') and to undertake feasibility and pilot studies of the novel programme.

METHODS-All patients attending a TIA clinic in Belfast within 4 weeks of their first TIA/mild stroke will be invited to participate. The novel home-based programme manual will be developed following systematic reviews of the literature and qualitative exploration with the target population, using focus groups. A feasibility study will initially be undertaken lasting 6 weeks and then developed into a pilot trial of 12 weeks duration. The feasibility will recruit to 3 different treatments: (1) standard care; (2) standard care plus the manual; (3) standard care, manual plus a pedometer. Whilst for the pilot study there will also be 3 arms but this will include: 1) control group; 2) manual and pedometer supported by telephone follow-up with a GP; 3) manual and pedometer supported by telephone follow-up with a stroke nurse. Interviews and focus groups will be employed to assess the interventions' acceptability. The intervention, 'The Healthy Brain Rehabilitation Manual' will be refined and modified at all stages of the research.

CONCLUSIONS - The findings will inform the development of a novel secondary prevention programme, 'The Healthy Brain Rehabilitation Manual', for TIA/minor stroke patients and of a trial to test its effectiveness and longer-term potential to improve outcomes for TIA/stroke patients.


Options:
A: Jette Late Life Functional and Disability Instrument (LLFDI) (3 months)
B: Global measure of lifestyle behavior (Health Promoting Lifestyle Profile II) (End of program (6 months))
C: Rate of recruitment to the studies (12 weeks (pilot study))
D: Change in walking activity from admission to discharge from rehabilitation (Admission and discharge from in-patient rehabilitation (approx. 4-6 weeks)); Change in control of walking (Admission and discharge from in-patient rehabilitation (approx. 4-6 weeks))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Blinded, Parallel Group, Multi-center Dose-finding Study, to Assess the Efficacy, Safety and Tolerability of Different Doses of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection
Brief Summary: The purpose of this study was to support the selection of a safe and tolerable tobramycin inhalation powder (TIP) dose, and regimen that exhibits effective bacterial reduction of P. aeruginosa in non-cystic fibrosis bronchiectasis (BE) patients with P. aeruginosa colonization.


Options:
A: Change in QOL-B Respiratory Symptoms Score at Day 28 (Baseline to Day 28)
B: Change From Baseline to Day 29 in Pseudomonas Aeruginosa (P. Aeruginosa) Density in Sputum (log10 CFUs) (Baseline (Visit 101/Day 1), Visit 102 (Day 8), Visit 103 (Day 29))
C: Time to first pulmonary exacerbation (from baseline) (48 weeks)
D: Time to First Exacerbation Event Within 48 Weeks (Up to Week 48)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Adapting and Implementing the Blended Collaborative Care Model in CBOCs
Brief Summary: Integrating mental health treatments into the primary care delivered at Community Based Outpatient Clinics(CBOCs) that are geographically accessible to rural Veterans is a major priority for the Department of Veterans Affairs. However, there is no scientific evidence that integrating mental health and primary care is clinically effective at smaller CBOCs that have limited mental health staffing. The goal of this proposed project is to implement a "blended" combination of integrated care models that have been adapted for smaller CBOCs using telemedicine technologies, and evaluate the acceptability and effectiveness of the blended, telemedicine-based, integrated care model. If clinical outcomes are improved compared to usual care, findings will be used to justify and facilitate the implementation of this telemedicine-based integrated care model at smaller CBOCs in order to increase rural Veterans' access to effective mental health treatments.


Options:
A: Relative dose intensity (Assessed every 30 days from randomization up to 6 months)
B: Change in VR-12 Mental Component Summary Scores (Six months)
C: healing time for leg ulcer and/or diabetes related foot ulcer (one year)
D: Total Number of Participants That Successfully Completed Remote Follow up (1 year 4 months); Total Number of Participants Who Ever Completed Remote Follow-up Requests (1 year 4 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Palliative Care to Improve Quality of Life in CHF and COPD
Brief Summary: Chronic heart failure (CHF), chronic obstructive pulmonary disease (COPD), and interstitial lung disease (i.e., pulmonary fibrosis) are common serious illnesses. Despite disease-specific medical care, people with these illnesses often left with poor quality of life (i.e., burdensome symptoms, impaired function). Furthermore, while these illnesses are leading causes of hospitalization and mortality, few people with these illnesses engage in advance care planning, the process of considering and communicating healthcare values and goals. The investigators are conducting a randomized clinical trial to study a symptom management, psychosocial care and advance care planning intervention to improve quality of life. The study is important because it aims to improve quality of life and provision of care according to peoples' goals and preferences in common, burdensome illnesses. Furthermore, this study will generate information that supports the broader dissemination and implementation of the intervention and informs the development of future palliative care and team-based interventions in the VA.


Options:
A: efficacy of PC-ACP
B: Proportion of patients receiving end of life care consistent with their stated preferences (one year)
C: quality of communication (1 month after intervention completed)
D: Function Assessment of Chronic Illness Therapy-General (FACT-G) (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Liberal Oxygenation Versus Conservative Oxygenation in Patients With Acute Respiratory Distress Syndrome : Impact on Mortality (LOCO2 Study)
Brief Summary: No clear recommendation exists for the level of oxygenation of intensive care patients. In Acute Respiratory Distress Syndrome (ARDS), pulsed oxymetry (SpO2) have to be kept between 88 and 95 percent and oxygen alveolar pressure between 55 and 80 mmHg (PaO2). These recommendations are common but do not lie on high scientific knowledge and level of proof. In the major studies of these fifteen last years that changed ARDS management, PaO2 was kept around 85 and 90 mmHg despite current recommendations of 55 to 80 mmHg of PaO2.

Many recent review and cohort studies pointed the risk of excessive oxygenation especially following cardiac arrest, stroke or traumatic brain injury. However, these data come in majority from cohort or database study without strong definition of hyperoxia. Data coming from prospective studies are scarce and tend to show better outcome of patients with lower objectives of oxygenation in ICU.

High oxygen (O2) level may be deleterious especially on inflammatory lungs. It could enhance injuries due to mechanical ventilation. O2 could be responsable of " hyperoxia induced lung injury ".

The investigators showed in a precedent study that comparing a restrictive oxygenation versus a liberal oxygenation was feasable and do not expose patients to major adverse events. More, mortality at 60 days has tendency to be lower. The investigators therefore ask if a lower objectives of PaO2 in comparison with the level usually seen in last studies on ARDS could improve ARDS patients outcome.

The aim of this study is to show that a restrictive oxygenation in comparison with a liberal oxygenation strategy in patients with ARDS would lower mortality at 28 days.


Options:
A: Myocardial salvage index (Day 4-6 after the acute PCI)
B: All-cause mortality or severe anoxic brain injury (3 months after OHCA.)
C: Composite Primary Outcomes (30 days)
D: Death (Day 28)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Wisconsin Tobacco Quit Line Centers for Medicaid Services Striving To Quit Evaluation Project
Brief Summary: The study is designed to test the hypotheses that financial incentives can increase both participation in smoking cessation treatment and resulting cessation rates, when they are offered to BadgerCare Plus (Medicaid) smokers as part of their health care.


Options:
A: Abstinence From Smoking (Measured 6 months after enrollment at follow-up assessment)
B: Salivary cotinine or anabasine testing (metabolites of nicotine) (at 6 months following the patient selected target quit date.)
C: Urinary Cotinine (3 weeks)
D: Biochemically verified smoking cessation rates at 6 months post-quit date

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Adjuvant Stereotactic Fractionated Radiotherapy to the Resection Cavity in Recurrent Glioblastoma
Brief Summary: This multi-center randomized controlled phase II trial will investigate the impact of stereotactic fractionated radiotherapy to the resection cavity of complete resected recurrent glioblastoma on progression free survival. As secondary endpoints, overall survival, safety and toxicity as well as early response criteria on MRI, quality of life and neurocognitive function will be assessed. Chemotherapy will not be part of the protocol, however, additional treatment will be possible upon investigators best choice.


Options:
A: Progression free survival (PFS) at 12 months (1 year)
B: The primary end point was 6-month progression-free survival rate (PFS-6) (6 months)
C: Survival 6 mo (Proportion of alive participants at 6 months)
D: Progression Free Survival (PFS) (Baseline at 6 weeks and then every 6 weeks to discontinuation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Healthy Eating and Active Playtime by Connecting Preschool Children to Nature
Brief Summary: Recent research suggests a majority of Hong Kong's toddlers (aged 2 to 4) are much less active than is recommended and are increasingly engaged in sedentary behaviour, which places them at risk of becoming overweight or obese. The proposed project will test whether connecting families to nature positively influences physical activity (that is, active playtime) and healthy eating routines in children aged 2 to 4. The investigators have recently conducted a pilot study Play \& Grow (P\&G), a programme based on the most successful international preschool interventions described in the literature. In addition to adopting healthy eating and physical activity intervention elements, the programme was enhanced by including a novel third element: connectedness to nature (CN). To test the effectiveness of this enhanced intervention, the plan is to run a family-based randomised controlled trial (RCT). The intervention will include 240 families with children aged 2 to 4, will take the form of one-hour activity sessions for parents and children held once a week for 10 weeks. The investigators will assess lifestyle-related habits before, immediately after the completion the intervention, at 6 months and one year after the intervention. Created for this purpose, a novel measuring tool for connectedness to nature, Nature Relatedness Scale (NRS), will be validated and tested for reliability prior to the RTC. The results of RCT are intended to be used to understand which components of the intervention were most effective. The objectives of this project will be achieved over a 36-month period, and it is expected to contribute to a close examination of key components of successful healthy lifestyle promotion programme during early childhood. The investigators predict that is that the new element CN will significantly improve the intervention. Finally, the overall aim is that connecting families to nature will result in sustainable lifestyle changes that remain with them for a lifetime.


Options:
A: Exhibited emotion, Feeding decisions, self-reported attitudes, beliefs and intentions; perceptual responses (At lab visit)
B: Eating habits (3 years); Physical activity (3 years); Nature relatedness (3 years)
C: Body fat (At the end of the intervention and at a six month follow-up)
D: Vitamin D plasma concentrations (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Healthy Eating and Active Playtime by Connecting Preschool Children to Nature
Brief Summary: Recent research suggests a majority of Hong Kong's toddlers (aged 2 to 4) are much less active than is recommended and are increasingly engaged in sedentary behaviour, which places them at risk of becoming overweight or obese. The proposed project will test whether connecting families to nature positively influences physical activity (that is, active playtime) and healthy eating routines in children aged 2 to 4. The investigators have recently conducted a pilot study Play \& Grow (P\&G), a programme based on the most successful international preschool interventions described in the literature. In addition to adopting healthy eating and physical activity intervention elements, the programme was enhanced by including a novel third element: connectedness to nature (CN). To test the effectiveness of this enhanced intervention, the plan is to run a family-based randomised controlled trial (RCT). The intervention will include 240 families with children aged 2 to 4, will take the form of one-hour activity sessions for parents and children held once a week for 10 weeks. The investigators will assess lifestyle-related habits before, immediately after the completion the intervention, at 6 months and one year after the intervention. Created for this purpose, a novel measuring tool for connectedness to nature, Nature Relatedness Scale (NRS), will be validated and tested for reliability prior to the RTC. The results of RCT are intended to be used to understand which components of the intervention were most effective. The objectives of this project will be achieved over a 36-month period, and it is expected to contribute to a close examination of key components of successful healthy lifestyle promotion programme during early childhood. The investigators predict that is that the new element CN will significantly improve the intervention. Finally, the overall aim is that connecting families to nature will result in sustainable lifestyle changes that remain with them for a lifetime.


Options:
A: Eating habits (3 years); Physical activity (3 years); Nature relatedness (3 years)
B: Infant weight for height (One year after study entry)
C: Body Mass Index score(BMI sds) at the age 6 years to monitor the effectiveness of the intervention (5 years)
D: fasting blood glucose (Baseline to 10 months postpartum); weight (body mass index) (Baseline to 10 months postpartum)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Healthy Eating and Active Playtime by Connecting Preschool Children to Nature
Brief Summary: Recent research suggests a majority of Hong Kong's toddlers (aged 2 to 4) are much less active than is recommended and are increasingly engaged in sedentary behaviour, which places them at risk of becoming overweight or obese. The proposed project will test whether connecting families to nature positively influences physical activity (that is, active playtime) and healthy eating routines in children aged 2 to 4. The investigators have recently conducted a pilot study Play \& Grow (P\&G), a programme based on the most successful international preschool interventions described in the literature. In addition to adopting healthy eating and physical activity intervention elements, the programme was enhanced by including a novel third element: connectedness to nature (CN). To test the effectiveness of this enhanced intervention, the plan is to run a family-based randomised controlled trial (RCT). The intervention will include 240 families with children aged 2 to 4, will take the form of one-hour activity sessions for parents and children held once a week for 10 weeks. The investigators will assess lifestyle-related habits before, immediately after the completion the intervention, at 6 months and one year after the intervention. Created for this purpose, a novel measuring tool for connectedness to nature, Nature Relatedness Scale (NRS), will be validated and tested for reliability prior to the RTC. The results of RCT are intended to be used to understand which components of the intervention were most effective. The objectives of this project will be achieved over a 36-month period, and it is expected to contribute to a close examination of key components of successful healthy lifestyle promotion programme during early childhood. The investigators predict that is that the new element CN will significantly improve the intervention. Finally, the overall aim is that connecting families to nature will result in sustainable lifestyle changes that remain with them for a lifetime.


Options:
A: Eating habits (3 years); Physical activity (3 years); Nature relatedness (3 years)
B: Change in mother daily fruit and vegetable intake in the past month between baseline, immediate-post intervention and 6-months post-intervention, assessed using the NCI Fruit and Vegetable All-Day Screener (Baseline, 4 months, 10 months)
C: Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment (0, 3 months); Change in Children´s Time of Physical Activity From Baseline to 3 Months by Intervention Assignment (0, 3 months); Change in Score z of Body Mass Index From Baseline to 3 Months by Intervention Assignment (0, 3 month)
D: 1 Year change in insulin resistance via HOMA-IR (Change during first year); 2 year change in insulin resistance via HOMA-IR (Change during 2 years)

Answer: A