TrialPanorama/Dataset huggingface dataset:
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: The primary endpoint will be change from baseline in the dyspnoea domain of the Chronic Respiratory Questionnaire (CRQ). (14 Months)
B: Steps per day as mean over one week from baseline until the treatment end (Every day for 6 months)
C: Number of exacerbations (12 months)
D: Exercise behavior (3 & 6 Months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Myocardial Ischemia and Transfusion: A Pilot, Multi-centre, Open-label Randomized Controlled Trial of Two Commonly Used Transfusion Strategies in Patients With Myocardial Infarction.
Brief Summary: MINT: A pilot, multi-centre, open-label randomized controlled trial of two commonly used transfusion strategies in patients with myocardial infarction.


Options:
A: Composite score of any one of the following: (1) all-cause mortality; (2) myocardial infarction; (3) new renal failure requiring dialysis; or (4) new focal neurological deficit (Up to hospital discharge or postoperative day 28 (whichever occurs first))
B: Overall adherence to the transfusion strategies defined as adherence to the transfusion strategies in 90% of patients in more than 90% of their days in hospital. (Day of surgery through to hospital discharge.)
C: Enrollment rate (Time Frame: 6 months); Non-adherence (30 days)
D: The primary purpose of this study is to compare clinical outcomes after cardiac surgery in patients submitted to different strategies of red blood cell transfusion (30 days after surgery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Myocardial Ischemia and Transfusion: A Pilot, Multi-centre, Open-label Randomized Controlled Trial of Two Commonly Used Transfusion Strategies in Patients With Myocardial Infarction.
Brief Summary: MINT: A pilot, multi-centre, open-label randomized controlled trial of two commonly used transfusion strategies in patients with myocardial infarction.


Options:
A: Timed Up and Go-test (TUG)in seconds. (30 days)
B: Enrollment rate (Time Frame: 6 months); Non-adherence (30 days)
C: Incidence of Blood Stream Infection (1 week after randomization and weekly thereafter through discarge from hospital)
D: Occurrence of a composite endpoint (90 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Myocardial Ischemia and Transfusion: A Pilot, Multi-centre, Open-label Randomized Controlled Trial of Two Commonly Used Transfusion Strategies in Patients With Myocardial Infarction.
Brief Summary: MINT: A pilot, multi-centre, open-label randomized controlled trial of two commonly used transfusion strategies in patients with myocardial infarction.


Options:
A: number of patients receiving the transfusion of at least one unit of allogeneic red blood cell (between the begining of surgery (day 1) and the eighth post-operative day (day 8))
B: A Composite of In-hospital Postoperative Morbidity and Mortality (After surgery until hosptal discharge)
C: Functional ability (Measured 10 days after surgery + repeated measurement during 90 days after surgery)
D: Enrollment rate (Time Frame: 6 months); Non-adherence (30 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Physical Exercise With Flow Restriction on the Diameter and the Flow of the Blood Vessels of the Forearm in Chronic Kidney Disease: a Randomized Clinical Trial
Brief Summary: The aim of this study is to analyze the effectiveness of physical exercise with blood flow restriction on the diameter and the flow of vessels, muscle strength and circumference of the forearm in patients with CKD prior to making FAV.


Options:
A: Hemodynamics in the fistula artery and vein, pre and post AV fistula formation (22 weeks)
B: Increasing the diameter of the cephalic vein (8 weeks of training for each patient)
C: Brachial artery flow-mediated dilatation (6 weeks)
D: Changes in blood flow of AVF draining vein (from Baseline to 3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Impact of Hypothermic Machine Perfusion in Renal Transplant Recipients
Brief Summary: This is a multi-centers prospective, randomized, controlled trial. This trial will investigate the clinical outcome of kidney transplant recipients whose kidneys are under two different forms of organ preservation--hypothermic machine perfusion vs. static cold storage. Factors during the machine perfusion, such as the pressure, flow rate, and resistance index will also be investigated.


Options:
A: The rate of Delayed graft function (the first week after transplant)
B: Delayed graft function (DGF) rate defined as the need to resort to dialysis during the first week after transplantation. The main dialysis factors retained are hydrosodic and/or hyperkalemic overload. (First week after transplantation)
C: Kidney function (After 6 months postoperatively)
D: Rate of graft loss (at 6 months postoperatively); Rate of Ischemic Type Biliary Lesions (ITBL) (at 6 months postoperatively)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of Fremanezumab (TEV-48125) Versus Placebo for the Preventive Treatment of Chronic Migraine
Brief Summary: The study is being conducted to evaluate two doses of TEV-48125 in adult patients with chronic migraine


Options:
A: Change in Frequency of Headache Days (Baseline, Week 24)
B: Change From Baseline in the Monthly Average Number of Headache Days of At Least Moderate Severity During the 12-Week Period After the First Dose of Study Drug (Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12)); Participants With Treatment-Emergent Adverse Events (TEAEs) (Day 1 to Week 12)
C: Change in Frequency of Headache Episodes (Baseline, Week 24)
D: 100 mm visual analog scale (VAS)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: New Technology and Child Health
Brief Summary: Background:

We are involved in testing new behavioral science methods and measures for future research projects. In the course of these evaluations, we will also test research questions related to parents psychological experiences and how these relate to the responses they have when they encounter different types of communication about child health. We are testing multiple research questions in the course of this research.

Objective:

- To learn about technologies and approaches to use in future research studies.

Eligibility:

- Parents (fathers and mothers) of children between the ages of 3-7.

Design:

As part of the main study, participants will do four tasks:

Task 1: Before participants arrive for an in-person visit, they will answer questions online about themselves, their child, and their thoughts and opinions related to health.

Task 2: At the in-person visit, participants will watch a short scene from a movie and answer some questions

Task 3: At the in-person visit, participants will read information about a child health topic and answer questions

Task 4: At the in-person visit, participants will use a virtual reality-based buffet restaurant simulation to make hypothetical food choices for their child...


Options:
A: Child anthropometry (Baseline. Up to 12 months. Up to 24 months.); Child food intake (Baseline. Up to 12 months. Up to 24 months.); Child health (Baseline. Up to 12 months. Up to 24 months.); Distribution of food intake within the household (Baseline. Up to 12 months. Up to 24 months.); Household food security (Baseline. Up to 12 months. Up to 24 months.); Maternal nutrition knowledge (Baseline. Up to 12 months. Up to 24 months.)
B: Primary Outcome Measure: BMI (6 months, 1 year, 2 year, 5 year)
C: Exhibited emotion, Feeding decisions, self-reported attitudes, beliefs and intentions; perceptual responses (At lab visit)
D: fasting blood glucose (Baseline to 10 months postpartum); weight (body mass index) (Baseline to 10 months postpartum)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: New Technology and Child Health
Brief Summary: Background:

We are involved in testing new behavioral science methods and measures for future research projects. In the course of these evaluations, we will also test research questions related to parents psychological experiences and how these relate to the responses they have when they encounter different types of communication about child health. We are testing multiple research questions in the course of this research.

Objective:

- To learn about technologies and approaches to use in future research studies.

Eligibility:

- Parents (fathers and mothers) of children between the ages of 3-7.

Design:

As part of the main study, participants will do four tasks:

Task 1: Before participants arrive for an in-person visit, they will answer questions online about themselves, their child, and their thoughts and opinions related to health.

Task 2: At the in-person visit, participants will watch a short scene from a movie and answer some questions

Task 3: At the in-person visit, participants will read information about a child health topic and answer questions

Task 4: At the in-person visit, participants will use a virtual reality-based buffet restaurant simulation to make hypothetical food choices for their child...


Options:
A: Mean Nutrition Environment Score (Measures collected 3-12 weeks prior to start of intervention (Baseline) and 1-8 weeks post-12-month intervention (Follow-up)); Mean Physical Activity Environment Score (Measures collected 3-12 weeks prior to start of intervention (Baseline) and 1-8 weeks post-12-month intervention (Follow-up))
B: body mass index (three years)
C: Change from Baseline in physical activity level of children at 1 and 4 months (After 1 and 4 months); Change from Baseline in sedentary behavior of children at 1 and 4 months (After 1 and 4 months); Change from Baseline in healthy diet of children at 1 and 4 months (After 1 and 4 months)
D: Exhibited emotion, Feeding decisions, self-reported attitudes, beliefs and intentions; perceptual responses (At lab visit)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Multicenter, Open-Label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Patients With Inhibitors
Brief Summary: This multicenter, open-label study will evaluate the safety, efficacy and pharmacokinetics of prophylactic emicizumab treatment in participants previously treated with episodic or prophylactic bypassing agents. Episodic bypassing agent participants will be randomized in a 2:1 fashion to receive emicizumab prophylaxis (Arm A) versus no prophylaxis (Arm B) and will be stratified across Arms A and B according to the number of bleeds they experienced over the last 24 weeks prior to study entry (less than \[\<\] 9 or greater than or equal to \[\>/=\] 9 bleeds); Arm B participants will have the opportunity to switch to emicizumab prophylaxis after at least 24 weeks on-study. Prophylactic bypassing agent participants will switch to emicizumab prophylaxis (Arm C) from the start of the trial; enrollment will be extended for 24 weeks after the last participant has enrolled in Arms A or B or until approximately 50 participants have enrolled in Arm C, whichever occurs first. Episodic bypassing agent participants who previously participated in the non-interventional study BH29768 (NCT02476942) who were unable to enroll in Arms A or B, or participants on prophylactic bypassing agents who were unable to enroll in Arm C, prior to their closure will have the opportunity to enroll in Arm D. Like participants in Arms A and C, Arm D participants will receive emicizumab prophylaxis from the start of the trial. All participants will continue to receive episodic bypassing agent therapy to treat breakthrough bleeds, preferably with recombinant activated factor VII (rFVIIa).


Options:
A: Annualized Number of Bleeding Episodes (Baseline up to Week 56)
B: Number of Bleeds During 6 Month Treatment Period (6 months)
C: Evaluate the efficacy, safety and pharmacoeconomic of long-term secondary prophylaxis with Kogenate Bayer in comparison to on-demand treatment with Kogenate Bayer in terms of joint bleeding episodes per year (Every 6 months)
D: Model-Based Annualized Bleed Rate (ABR) for Treated Bleeds, Arm A: Emicizumab Versus Arm B: No Prophylaxis (From Baseline up to 24 weeks (median [min-max] efficacy observation periods in Arm A vs. Arm B: 29.29 [0.1-48.9] weeks vs. 24.14 [23.0-26.0] weeks))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Weight Loss Through Diet and Exercise in Overweight Women With Breast Cancer: A Four-arm Randomized Trial
Brief Summary: The investigators aim to evaluate the effect of a 6-month intervention (counseling) focused on weight loss in a group of overweight or obese women previously treated for early breast cancer. Intervention is designed to improve adherence to a healthy diet or/and to increase physical activity and decrease sedentary time, taking advantage of a pedometer-like device.


Options:
A: Body weight reduction (baseline - 6 month)
B: Weight loss (2 years)
C: Weight loss (2 years)
D: Physical function as assessed by Short-Form Health Survey (SF-36) with physical function subscale and late effects lower body subscales at baseline and years 1 and 2 following study completion (one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: In Vivo Reflectance Confocal Microscopy, a Novel Non-invasive Tool for Diagnosing Skin Cancer - A Randomized Controlled Trial
Brief Summary: Skin cancer is the most common cancer and its incidence is increasing rapidly. The rising number of skin cancer may result in long waiting lists for consultation at departments for dermatological care and in increasing health care costs. In case of suspicion on skin cancer it is of utmost importance to diagnose and treat in an early phase, preferable in a patient friendly manner. Skin cancer comprises melanoma and non-melanoma skin cancer (NMSC: basal cell carcinoma (BCC), squamous cell carcinoma (SCC) and its precursors actinic keratosis (AK) and Bowen disease). As BCC is the most common skin cancer type with an estimated incidence of 51,000 new tumors in 2015 (The Netherlands), this study will focus on this skin cancer type. In case of suspicion on BCC, at present, the pathological examination of a biopsy is the gold standard for diagnosing a BCC. With the implementation of non invasive diagnosis by reflectance confocal microscopy (RCM) in routine patient care settings the diagnosis can be assessed at the first consultation in a non-invasive way and the patient can be treated instantly.

Overall, the aim of this study is to investigate whether reflectance confocal microscopy can correctly identify the subtype of basal cell carcinoma.

Study design: Randomized controlled trail. Comparison with usual care: punch biopsy and excision.


Options:
A: Objective Response (OR) Determined by the Independent Review Facility (From study initiation (enrollment of first patient) through 9 months following the first treatment of the last enrolled patient (clinical cutoff date of 26 November 2010), up to 90 weeks)
B: Absence of local recurrence at 3 years after start of treatment
C: The number of correctly identified basal cell carcinoma and the subtype by Reflectance confocal microscopy validated by histopathological examination of the excision specimen (Through study completion, an average of 3 years)
D: Comparison between one stop shop using reflectance confocal microscopy in the surgical treatment of BCC and current standard of care using punch biopsy, by assessing incomplete surgical excision on the final pathology report. (Within the first week after surgical excision of suspected BCC lesion)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: In Vivo Reflectance Confocal Microscopy, a Novel Non-invasive Tool for Diagnosing Skin Cancer - A Randomized Controlled Trial
Brief Summary: Skin cancer is the most common cancer and its incidence is increasing rapidly. The rising number of skin cancer may result in long waiting lists for consultation at departments for dermatological care and in increasing health care costs. In case of suspicion on skin cancer it is of utmost importance to diagnose and treat in an early phase, preferable in a patient friendly manner. Skin cancer comprises melanoma and non-melanoma skin cancer (NMSC: basal cell carcinoma (BCC), squamous cell carcinoma (SCC) and its precursors actinic keratosis (AK) and Bowen disease). As BCC is the most common skin cancer type with an estimated incidence of 51,000 new tumors in 2015 (The Netherlands), this study will focus on this skin cancer type. In case of suspicion on BCC, at present, the pathological examination of a biopsy is the gold standard for diagnosing a BCC. With the implementation of non invasive diagnosis by reflectance confocal microscopy (RCM) in routine patient care settings the diagnosis can be assessed at the first consultation in a non-invasive way and the patient can be treated instantly.

Overall, the aim of this study is to investigate whether reflectance confocal microscopy can correctly identify the subtype of basal cell carcinoma.

Study design: Randomized controlled trail. Comparison with usual care: punch biopsy and excision.


Options:
A: Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 in Combination With gp 100 Melanoma Peptide Vaccine Versus gp 100 Melanoma Peptide Vaccine Alone (From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks))
B: Overall Survival (OS) (Date of randomization to 37 months through 5-year follow-up and up to approximately 76 months)
C: The number of correctly identified basal cell carcinoma and the subtype by Reflectance confocal microscopy validated by histopathological examination of the excision specimen (Through study completion, an average of 3 years)
D: To determine whether wide excision of the primary with intraoperative lymphatic mapping (LM) followed by selective lymphadenectomy will effectively prolong overall survival compared to wide excision of the primary melanoma alone. (10 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Navigating High Risk Surgery: Empowering Older Adults to Ask Questions That Inform Decisions About Surgical Treatment
Brief Summary: The investigators will perform a multi-site cluster randomized trial that uses a stepped-wedged design to compare the effectiveness of a Question Prompt List (QPL) intervention to usual care for patients considering high-risk vascular (peripheral, cardiac, neuro) and oncologic operations. This 24-month study will use a time-dependent cluster randomization plan within each of the five study sites: the investigators will randomly assign time points for surgeons who perform high risk operations to cross over from usual care to QPL intervention. Study staff will audiotape the conversation between the patient and surgeon during one preoperative clinic visit; administer surveys to patients and family members at 24 hours, 6 weeks and 12 weeks after that visit; and record surgical decisions, treatments received and associated outcomes. The investigators will use stratified purposeful sampling to identify a subset of patients in each study arm who have experienced serious complications for qualitative interviews.


Options:
A: Change from baseline in prevalence of child wasting (baseline, and then at each study visit (every 6 months over 36 months))
B: Frequency of Evidence Based Strategies (Discharge or 7 days after admission); Composite Adherence Score (Discharge or 7 days after admission)
C: Appropriate treatment of malaria, pneumonia and diarrhoea in children under five years of age (1 year)
D: Patient Engagement in Decision Making Measured by Clinic Visit Transcript Coding for Number of and Types of Questions Raised (Within 2 hours of enrollment in the study); Change in Illness-related Stress Measured by Participant Self-report on MYCaW Instrument (24-48 hours after enrollment, 6-8 weeks post-enrollment and 3-4 months post-enrollment); Perceived Self-efficacy in Patient-physician Interactions Measured by Participant Self-report on the PEPPI-5 Scale (24-48 hours after enrollment); Post-treatment Regret Measured by a Specific Participant Self-report Survey Item (3-4 months post-enrollment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of Pedometers to Measure and Increase Walking Among Patients With ESRD
Brief Summary: Randomized controlled trial using pedometers to increase physical activity among patients on dialysis.


Options:
A: Change in non-invasive measures of arterial stiffness using applanation tonometry. (4 months and 8 months after study initiation)
B: Number of patients who correct the state of protein energy wasting in intervention group compared to a control group (at 6 months)
C: Physical Activity (Baseline and 12 weeks)
D: Change in Body Heat Storage (Changes from baseline at 7 months); Change in Insulin Resistance (Changes from baseline at 7 months); Change in Muscle Size (Changes from baseline at 7 months)

Answer: C