TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Monitoring Adherence Using Mobile Technology
Brief Summary: This study plans to learn more about how children use their asthma medicines. The investigators would like to see if special electronic monitoring devices that connect to smartphones and computers can help children to better manage their asthma


Options:
A: Number of patient participants that rate the devices as easy to use (3 months); Number of provider participants that rate the devices as easy to use (3 months)
B: Objective Adherence to ICS (Baseline); Change in objective adherence to ICS (Change from baseline in objective adherence to ICS at 1 month); Change in objective adherence to ICS (Continuous change over time from baseline in objective adherence to ICS at 2 months in intervention compared to control); Change in objective adherence to ICS (Continuous change over time from baseline in objective adherence to ICS at 3 months in intervention compared to control); Change in objective adherence to ICS (Continuous change over time from baseline in objective adherence to ICS at 4 months in intervention compared to control); Change in objective adherence to ICS (Continuous change over time from baseline in objective adherence to ICS at 5 months in intervention compared to control); Feasibility, Acceptability and Usability of the Text Messaging Website (At time of text messaging intervention); Feasibility, Acceptability and Usability of the Text Messaging Website (up to 1 month after receiving text messages); Feasibility, Acceptability and Usability of the Text Messaging Website (up to 2 months after receiving text messages); Feasibility, Acceptability and Usability of the Text Messaging Website (up to 3 months after receiving text messages)
C: Adherence rate (at three months)
D: Asthma control - as measured by the Asthma Control Test (Measured at Year 1)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Telemedical Support for Prehospital Emergency Medical Service - a Prospective Randomized Controlled Trial
Brief Summary: The purpose of this study is to evaluate the safety and quality of a pre-hospital holistic multifunctional teleconsultation system. This system consists of on-line transmissions of vital parameters, audio- and video-signals from the scene to a telemedicine centre, where a trained emergency physician (tele-EMS physician) uses software-based guideline conform algorithms for diagnosis and treatment.

At the prehospital emergency scene half of the patients will receive this telemedicine-based approach and the other half the conventional emergency physician-based care.


Options:
A: Intervention-related adverse events (1 day)
B: Safety and quality of health care (1 year)
C: Changes in mean SBP (From baseline (T1) to 12 months (T3))
D: Relative dose intensity (Assessed every 30 days from randomization up to 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1B Multiple Dose Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER-287 in Subjects With Mild-to-Moderate Ulcerative Colitis
Brief Summary: A Multiple Dose Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER-287 in Subjects with Mild-to-Moderate Ulcerative Colitis.


Options:
A: Total PUCAI (Pediatric Ulcerative Colitis Activity Index) score (at day 5 after treatment (compared between the two treatment groups).)
B: Safety and Tolerability of SER-287 (Day 246); Composition of the Intestinal Microbiome (Baseline and 8 weeks); Engraftment of SER-287 Bacteria in All Treatment Arms (Baseline and 8 weeks)
C: Response rate at 8 weeks defined as a drop in PCDAI (Pediatric Crohn's Disease Activity Index ) of at least 12.5 points (or remission without steroids, intention to treat principle) (8 weeks)
D: Clinical response as defined by the Oxford's criteria (48 hours)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of High Flow Oxygenation Therapy and CPAP in Children With Bronchiolitis.
Brief Summary: Bronchiolitis in infants and young children often requires respiraty support. In Denmark Continous Positive Airway Pressure ( CPAP) are routinely used in children with moderate-severe bronchiolitis. The aim of the study is to compare CPAP and High Flow Oxygenation Therapy (HFOT) as tools of respiratory support in infants and young children with bronchiolitis.

Infants and young children with moderate-severe bronchiolitis and are randomized to either CPAP or HFOT.


Options:
A: Number of eligible patients in Group A (step-up) and Group B (step-down) (Baseline); Number of parents/guardians who refuse prospective or deferred consent (Through study completion, an average of 24 hours); Randomising at least 50% of eligible patients (Baseline); Proportion of patients adherent to the study treatment (Through study completion, an average of 72 hours); Mean COMFORT score (72 hours); Number of parents completing the Parental Stressor Scale: PICU (PSS:PPICU) (24 hours)
B: The primary aim of this study is to show an improvement of the average levels of postextubation PaCO2 in infants less than 18 months of age and post-bypass surgery (Final outcome measure is assessed when 80 patients have been recruited.Outcome measure is assessed at the end of 48 hours postextubation and when the patient is discharged from the ICU.)
C: respiration rate (after 6 12 18 24 and 48 hour of intervention); PCo2 (after 6 12 24 and 48 hours of intervention); Modified asthma score (MWAS) (Once daily as long as intervention precedes ( 1-14 days))
D: Patient respiratory effort and tidal volume (Vt) (1h20)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The aims of this study were to compare health related quality of life, comforts degrees，retention effectiveness, and failure rates as well as survival times between two clear overlay retainers with different thicknesses, thus to provide basis information regarding appropriate selections of the thickness of clear overlay retainers.


Options:
A: Oral Health-Related Quality Of Life (6 month)
B: Compliance of retainer wear (3 months)
C: Survival times via recording to the patients' re-visit (one year)
D: Relapse tendency (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Cross-sectional Population Representative Internet Survey to Estimate Prevalence of Lower Urinary Tract Symptoms (LUTS) in China, Taiwan and South Korea
Brief Summary: The purpose of the study is to determine prevalence of lower urinary tract symptoms in population aged 40 years or over, in China, Taiwan and South Korea using latest ICS definition.


Options:
A: Collection of Post-treatment Catheterization for Safety (Cath within first 3 days post-procedure which extended beyond 7 days, up to 12 days); Comparison of IPSS for Efficacy (3 month); Mean UroLift Improvement in IPSS at 12 Months (12 months)
B: Responder Analysis: A Subject is a Responder at the 12 Month Follow-up Time Point if All 6 Thresholds of the BPH-6 Endpoint Are Met (Month 12)
C: The prevalence of lower urinary tract symptoms using ICS 2002 symptom definition (At enrollment)
D: Efficacy: Change From Baseline in the International Prostate Symptom Score (IPSS) at 3 Month Follow-Up (3 Month Follow-up Visit); Safety: Device Related Serious Complications (3 Months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Intravenous Versus Combined Oral and Intravenous Antimicrobial Prophylaxis for the Prevention of Surgical Site Infection in Elective Colorectal Surgery: A Double-blinded Multicenter Prospective Randomized Controlled Trial
Brief Summary: To assess the effects of a combined antimicrobial prophylaxis using oral ornidazole (the day before surgery) and intravenous cephalosporin (before surgical incision) with that of intravenous cephalosporin alone (standard of care) in combination with oral placebo on the incidence of SSI within 30 days after elective colorectal surgery.


Options:
A: Incidence of post-operative surgical site infection (SSI) including superficial/incisional, deep, and organ space, anastomotic dehiscence and leak (Up to 30 days post operation)
B: occurrence of any SSI within 30 days after surgery. (30 days after surgery)
C: Rate of Surgical Site Infection (0 to 30 days)
D: Surgical Site Infections (30 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Home Rehabilitation Via Telemonitoring of Vital Signs to Prevent Exacerbations in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: COPD is the fourth leading cause of death in the world and is the only one of the top five illnesses whose death rate is still increasing. It is mainly caused by smoking. Greece has a higher prevalence and death rate for COPD than many other countries in Europe. The disease is incurable so treatment is aimed at alleviating symptoms and slowing progression. Despite maximal medication and strategies such as pulmonary rehabilitation and home nurse support, many patients remain vulnerable, socially isolated and report difficulty in accessing their local health services. Research has shown that patients have worsening symptoms for an average of three to four days before they are admitted to hospital with an exacerbation of COPD. This suggests a window of opportunity to intervene. Early warning and contact via innovative technology may treat symptoms earlier, improve patient confidence / quality of life and simultaneously reduce health care visits or admissions. However, there is a large gap between the postulated and empirically demonstrated benefits of electronic Health Technologies. In addition, there is a lack of robust research on the risks of implementing these technologies and their cost-effectiveness has yet to be demonstrated, despite being frequently promoted by policymakers as if this was a given issue. In addition, the evidence-base for telehealth is not well-reported in peer reviewed journals and hence there continue to be difficulties experienced in convincing clinicians, hospital managers and stakeholders that investment in such technologies will enable reductions in other aspects of healthcare delivery over time.

This project attempts to provide robust justification of the effectiveness of telerehabilitation by the implementation of a randomized controlled trial blindly assigning COPD patients to: i) a home care and telerehabilitation group remotely monitored by a specialised private health care centre (Filoktitis - group A) or ii) a hospital-based rehabilitation group managed at a regular base through weekly visits by personnel at a state University rehabilitation centre (group B). iii) A third group that receives usual care (group C: control group; i.e.: neither home monitoring nor hospital based rehabilitation) is also included.


Options:
A: Number of exacerbations (12 months)
B: Change From Baseline in Inspiratory Capacity (IC) at Isotime (baseline, six weeks of treatment)
C: Exercise behavior (3 & 6 Months)
D: Walking time in daily life and the amount of time spent in moderate intense activities

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Home Rehabilitation Via Telemonitoring of Vital Signs to Prevent Exacerbations in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: COPD is the fourth leading cause of death in the world and is the only one of the top five illnesses whose death rate is still increasing. It is mainly caused by smoking. Greece has a higher prevalence and death rate for COPD than many other countries in Europe. The disease is incurable so treatment is aimed at alleviating symptoms and slowing progression. Despite maximal medication and strategies such as pulmonary rehabilitation and home nurse support, many patients remain vulnerable, socially isolated and report difficulty in accessing their local health services. Research has shown that patients have worsening symptoms for an average of three to four days before they are admitted to hospital with an exacerbation of COPD. This suggests a window of opportunity to intervene. Early warning and contact via innovative technology may treat symptoms earlier, improve patient confidence / quality of life and simultaneously reduce health care visits or admissions. However, there is a large gap between the postulated and empirically demonstrated benefits of electronic Health Technologies. In addition, there is a lack of robust research on the risks of implementing these technologies and their cost-effectiveness has yet to be demonstrated, despite being frequently promoted by policymakers as if this was a given issue. In addition, the evidence-base for telehealth is not well-reported in peer reviewed journals and hence there continue to be difficulties experienced in convincing clinicians, hospital managers and stakeholders that investment in such technologies will enable reductions in other aspects of healthcare delivery over time.

This project attempts to provide robust justification of the effectiveness of telerehabilitation by the implementation of a randomized controlled trial blindly assigning COPD patients to: i) a home care and telerehabilitation group remotely monitored by a specialised private health care centre (Filoktitis - group A) or ii) a hospital-based rehabilitation group managed at a regular base through weekly visits by personnel at a state University rehabilitation centre (group B). iii) A third group that receives usual care (group C: control group; i.e.: neither home monitoring nor hospital based rehabilitation) is also included.


Options:
A: "Quality of care process" (one year)
B: Number of exacerbations (12 months)
C: Composite score of changes in general self-efficacy (baseline, 3, 6, 12, 24 months)
D: COPD Assessment Test (CAT) (Baseline and 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Home Rehabilitation Via Telemonitoring of Vital Signs to Prevent Exacerbations in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: COPD is the fourth leading cause of death in the world and is the only one of the top five illnesses whose death rate is still increasing. It is mainly caused by smoking. Greece has a higher prevalence and death rate for COPD than many other countries in Europe. The disease is incurable so treatment is aimed at alleviating symptoms and slowing progression. Despite maximal medication and strategies such as pulmonary rehabilitation and home nurse support, many patients remain vulnerable, socially isolated and report difficulty in accessing their local health services. Research has shown that patients have worsening symptoms for an average of three to four days before they are admitted to hospital with an exacerbation of COPD. This suggests a window of opportunity to intervene. Early warning and contact via innovative technology may treat symptoms earlier, improve patient confidence / quality of life and simultaneously reduce health care visits or admissions. However, there is a large gap between the postulated and empirically demonstrated benefits of electronic Health Technologies. In addition, there is a lack of robust research on the risks of implementing these technologies and their cost-effectiveness has yet to be demonstrated, despite being frequently promoted by policymakers as if this was a given issue. In addition, the evidence-base for telehealth is not well-reported in peer reviewed journals and hence there continue to be difficulties experienced in convincing clinicians, hospital managers and stakeholders that investment in such technologies will enable reductions in other aspects of healthcare delivery over time.

This project attempts to provide robust justification of the effectiveness of telerehabilitation by the implementation of a randomized controlled trial blindly assigning COPD patients to: i) a home care and telerehabilitation group remotely monitored by a specialised private health care centre (Filoktitis - group A) or ii) a hospital-based rehabilitation group managed at a regular base through weekly visits by personnel at a state University rehabilitation centre (group B). iii) A third group that receives usual care (group C: control group; i.e.: neither home monitoring nor hospital based rehabilitation) is also included.


Options:
A: Hospitalization or Emergency Department Visit for COPD (1 yr); Hospitalization or ED Visit for COPD (Mean Cumulative Frequency) (1 yr)
B: Smoking cessation (point prevalence, both self reported as biochemical verified) (12 months)
C: Dyspnea; Exercise adherence and performance; Pulmonary exacerbations
D: Number of exacerbations (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Home Rehabilitation Via Telemonitoring of Vital Signs to Prevent Exacerbations in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: COPD is the fourth leading cause of death in the world and is the only one of the top five illnesses whose death rate is still increasing. It is mainly caused by smoking. Greece has a higher prevalence and death rate for COPD than many other countries in Europe. The disease is incurable so treatment is aimed at alleviating symptoms and slowing progression. Despite maximal medication and strategies such as pulmonary rehabilitation and home nurse support, many patients remain vulnerable, socially isolated and report difficulty in accessing their local health services. Research has shown that patients have worsening symptoms for an average of three to four days before they are admitted to hospital with an exacerbation of COPD. This suggests a window of opportunity to intervene. Early warning and contact via innovative technology may treat symptoms earlier, improve patient confidence / quality of life and simultaneously reduce health care visits or admissions. However, there is a large gap between the postulated and empirically demonstrated benefits of electronic Health Technologies. In addition, there is a lack of robust research on the risks of implementing these technologies and their cost-effectiveness has yet to be demonstrated, despite being frequently promoted by policymakers as if this was a given issue. In addition, the evidence-base for telehealth is not well-reported in peer reviewed journals and hence there continue to be difficulties experienced in convincing clinicians, hospital managers and stakeholders that investment in such technologies will enable reductions in other aspects of healthcare delivery over time.

This project attempts to provide robust justification of the effectiveness of telerehabilitation by the implementation of a randomized controlled trial blindly assigning COPD patients to: i) a home care and telerehabilitation group remotely monitored by a specialised private health care centre (Filoktitis - group A) or ii) a hospital-based rehabilitation group managed at a regular base through weekly visits by personnel at a state University rehabilitation centre (group B). iii) A third group that receives usual care (group C: control group; i.e.: neither home monitoring nor hospital based rehabilitation) is also included.


Options:
A: Steps per day as mean over one week from baseline until the treatment end (Every day for 6 months)
B: Number of exacerbations (12 months)
C: COPD Assessment Test (CAT) (Baseline and 6 months)
D: Change from baseline in Shuttle Walk test at 6 weeks (6 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Home Rehabilitation Via Telemonitoring of Vital Signs to Prevent Exacerbations in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: COPD is the fourth leading cause of death in the world and is the only one of the top five illnesses whose death rate is still increasing. It is mainly caused by smoking. Greece has a higher prevalence and death rate for COPD than many other countries in Europe. The disease is incurable so treatment is aimed at alleviating symptoms and slowing progression. Despite maximal medication and strategies such as pulmonary rehabilitation and home nurse support, many patients remain vulnerable, socially isolated and report difficulty in accessing their local health services. Research has shown that patients have worsening symptoms for an average of three to four days before they are admitted to hospital with an exacerbation of COPD. This suggests a window of opportunity to intervene. Early warning and contact via innovative technology may treat symptoms earlier, improve patient confidence / quality of life and simultaneously reduce health care visits or admissions. However, there is a large gap between the postulated and empirically demonstrated benefits of electronic Health Technologies. In addition, there is a lack of robust research on the risks of implementing these technologies and their cost-effectiveness has yet to be demonstrated, despite being frequently promoted by policymakers as if this was a given issue. In addition, the evidence-base for telehealth is not well-reported in peer reviewed journals and hence there continue to be difficulties experienced in convincing clinicians, hospital managers and stakeholders that investment in such technologies will enable reductions in other aspects of healthcare delivery over time.

This project attempts to provide robust justification of the effectiveness of telerehabilitation by the implementation of a randomized controlled trial blindly assigning COPD patients to: i) a home care and telerehabilitation group remotely monitored by a specialised private health care centre (Filoktitis - group A) or ii) a hospital-based rehabilitation group managed at a regular base through weekly visits by personnel at a state University rehabilitation centre (group B). iii) A third group that receives usual care (group C: control group; i.e.: neither home monitoring nor hospital based rehabilitation) is also included.


Options:
A: Self-management and Activation (6 Months)
B: 6 minute walk test (measured at week 8)
C: Number of exacerbations (12 months)
D: Clinical COPD Questionnaire (CCQ) (Up to 3 weeks); Timed Up & Go test (TUG) (Up to 3 weeks); The five time sit to stand test (FTSST) (Up to 3 weeks); Patients' falls during training (Up to 3 weeks); Need for acute contact to the general practitioner (Up to 3 weeks); Patient subjective perception (Up to 3 weeks); Costs per patient participating in the telemedicine rehabilitation (Up to 3 weeks); Reimbursement to the hospital (Up to 3 weeks); Focus Group interview (Up to 3 weeks)

Answer: C