TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of Volatile Anesthetics for Long-Term Sedation In Critically Ill Patients
Brief Summary: Heavy sedation or sleep is a common problem within the intensive care unit (ICU) using our standard intravenous medications. This commonly leads to confusion, low blood pressure, slow wake up and removal of the artificial breathing tube (extubation), which prolongs ICU stay. Using inhaled volatile anesthetic agents are likely to improve these patient outcomes. This unique project is the first North American study looking at using volatiles for patients who need longer-term ICU sedation. This project has excellent potential at lowering these complications and improving quality of care, which will lower patient ICU stay and healthcare costs.


Options:
A: time to successful extubation (This will be the length of time that the patient remains on continuous infusions of sedation and/or analgesia in the ICU. At 60 days, all study interventions will terminate, but patients will be followed for outcomes.)
B: atmospheric volatile concentration (daily); Sedation (daily); Feasibility (2 years); Education Tool (2 years); serum fluoride levels (every 2 days)
C: the rate of hematological remission; the rate of molecular remission; the kinetics of the MRD of PML/RARa during and after ATO
D: Number of patients returning to independent functional status: defined as ability to perform 6 activities of daily living (ADL's)(bathing, dressing, eating, grooming, transfer from bed to chair, toileting) and independent ambulation (Hospital Discharge)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Improved Cardiovascular Risk Reduction to Enhance Rural Primary Care
Brief Summary: The trial will examine whether a centralized Prevention Health \& Cardiovascular Risk Service (PHCVRS) run by clinical pharmacists at the University of Iowa can be implemented in primary care offices and whether it can improve the care delivered to patients at risk for developing cardiovascular disease.


Options:
A: Multiple CVD risk factor control targets (42 months after randomization)
B: HbA1c, Triglycerides, Cholesterol, Urine Microalbumin, Blood Pressure,
C: Adherence of medical regimen/treatment to all of the Guideline Advantage criteria that apply. (12 months for each participant)
D: HbA1c (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Improved Cardiovascular Risk Reduction to Enhance Rural Primary Care
Brief Summary: The trial will examine whether a centralized Prevention Health \& Cardiovascular Risk Service (PHCVRS) run by clinical pharmacists at the University of Iowa can be implemented in primary care offices and whether it can improve the care delivered to patients at risk for developing cardiovascular disease.


Options:
A: To assess the difference in frequency and severity of clinically significant DDIs in control arm and interventional arm between admission and discharge (90 days)
B: Blood Pressure Control (Baseline, 6 months, 12 months, 18 months); Mean Systolic Blood Pressure (Baseline, 6 months, 12 months, 18 months, 54 months); Mean Diastolic Blood Pressure (Baseline, 6 months, 12 months, 18 months, 54 months)
C: Adherence of medical regimen/treatment to all of the Guideline Advantage criteria that apply. (12 months for each participant)
D: The proportion of subjects who attain "optimal BP and lipid control" (defined as systolic BP < 140 mm Hg AND fasting LDL cholesterol < 2.0 mmol/L) compared to baseline. (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Immediate Effect of Acupuncture on Pain, Cervical Range of Motion and Electromyographic Activity of the Upper Trapezius Muscle in Patients With Nonspecific Neck Pain: Randomized, Single-blinded, Sham-controlled Study.
Brief Summary: The aim of the proposed study is to evaluate the immediate effect of acupuncture on pain, cervical range of motion and electromyographic activity of the upper trapezius muscle in patients with nonspecific neck pain.Twelve patients with nonspecific neck pain and 12 healthy subjects will be enrolled in a randomized, single-blind, crossover study. Each patient will receive two forms of treatment in random order: a single session of traditional acupuncture and sham acupuncture. To eliminate carry-over treatment effects, a one-week wash-out period will be respected between sessions. Surface electromyography will be used to determine motor control in the upper trapezius muscle before and after treatment. The outcome measures in the group with neck pain will be a numerical pain rating scale (range: 0 \[no pain\] to 10 \[maximum pain\]), documentation of the pain area on a body chart and cervical range of motion. Linear regression analysis will be applied for each individual to investigate associations between the sEMG variables and force (excluding the sixth step). The slopes of the regression lines will be used to measure the sensitivity of the sEMG variables regarding changes in force. The Shapiro-Wilk test will be used to test the normality of the data distribution regarding RMS and MDF values in the third and sixth step of the step contraction. Paired samples (Student's t-test or Wilcoxon test) will be used to test differences between third and sixth contraction step. A mixed linear model will be used to analyze and compare the sEMG data during sustained contraction (five steps) between pre-acupuncture (EMG-1) and post-acupuncture (EMG-2) evaluations. These comparisons will demonstrate whether acupoints TE-5 and LI-11 affect the activity of the upper trapezius muscle, as hypothesized. The pain (NRS, PPT and area) and cervical ROM data collected during the four evaluations will also be compared using a mixed linear model. The Statistical Package for Social Sciences (SPSS, version 19.0 for Windows) will be employed for the statistical analysis, with the level of significance set to 5% (p \< 0.05).


Options:
A: Pain Scores on the Visual Analogue Scale(VAS) (7 week)
B: muscle contractility (30 minutes)
C: electromyographic activity (1 Year)
D: Immediate reduction in pain intensity (at ED discharge (within 3 hours from ED admission))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open Cluster-randomized, 18 Month Trial to Compare the Effectiveness of Educational Outreach Visits With Usual Guideline Dissemination to Improve Family Physician Prescribing
Brief Summary: Background: The Portuguese National Health Directorate has issued clinical practice guidelines on prescription of anti-inflammatory drugs and COX-2 inhibitors, acid suppressive therapy and proton pump inhibitors, and anti-platelets. However, their effectiveness in changing actual practice is unknown. The objectives will be to compare the effectiveness of educational outreach visits in the implementation of clinical guidelines in primary care in Portugal against usual implementation strategies and to conduct a cost-effectiveness analysis of this method.

Methods: The trial will be a parallel, cluster-randomized, unblinded, trial in primary care, with a 1:1 allocation ratio. This study will assess the effect of educational outreach visits on physician compliance with prescription guidelines. The general study hypothesis is whether educational outreach visits are superior to usual implementation of guidelines regarding the reduction of inappropriate prescribing (compliance with prescription guidelines). All National Health Service primary care units in the Lisbon (Portugal) region will be invited to participate. Units will be eligible if they are using an Electronic Health Record to issue prescriptions and have at least four doctors willing to participate. Doctors in intervention units will receive three educational outreach visits (one for each guideline) during a six months period, while the control group doctors will be offered an unrelated group training session (on using the international classification for primary care). Intervention visits will be one on one 15 minutes discussions conducted by guideline authors or trained family physicians at the physician's workplace. There are two primary outcomes, measured at the physician's level. One is the proportion of COX-2 inhibitors prescribed within the entire NSAID class, in defined daily doses 18 months after the intervention. The other is the proportion of omeprazole within the entire proton pump inhibitors class, in defined daily doses at 18 months post-intervention. Prescription data will be collected from the regional pharmacy claims database.


Options:
A: Proportion of admitted injured adolescents receiving each element of the alcohol screening, brief intervention and referral to treatment (SBIRT) protocol (54 months)
B: Cumulative Incidence of ART Initiation 14 Days After Clinical Eligibility in Treatment Eligible HIV-infected Patients (14 days)
C: Proportion of COX-2 inhibitors prescribed within the entire NSAID class (18 months); Proportion of omeprazole prescribed within the entire proton pump inhibitors class (18 months)
D: Composite measure representing improvement in cholesterol-related secondary prevention consisting of (1) provision of a statin sample (2) provision of a statin prescription or (3) dosage increase of a statin within the first 6 months post-angiogram.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Administered as Monotherapy or in Combination With Bevacizumab Versus Sunitinib in Patients With Untreated Advanced Renal Cell Carcinoma
Brief Summary: This multicenter, randomized, open-label study will evaluate the efficacy, safety and tolerability of atezolizumab as monotherapy or in combination with bevacizumab versus sunitinib in participants with histologically confirmed, inoperable, locally advanced or metastatic renal cell carcinoma who have not received prior systemic therapy either in the adjuvant or metastatic setting.


Options:
A: Progression Free Survival First-Line (PFS 1-L) (based on radiological assessments every 3 months until disease progression, start of another antineoplastic therapy or for any other reason up to 35 months)
B: progression-free rate (at 48 weeks post-treatment)
C: Percentage of Participants With Disease Progression Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Via Independent Review Committee (IRC) Assessment or Death in Intent-to-Treat (ITT) Population (From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)); Progression-Free Survival (PFS) Per RECIST v1.1 Via IRC Assessment in ITT Population (From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)); Percentage of Participants With Disease Progression Per RECIST v1.1 Via IRC Assessment or Death in Immune Cell 1/2/3 (IC1/2/3) Population (From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)); PFS Per RECIST v1.1 Via IRC Assessment in IC1/2/3 Population (From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years))
D: Progression free survival in first-line treatment (Time of progression in first line treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Administered as Monotherapy or in Combination With Bevacizumab Versus Sunitinib in Patients With Untreated Advanced Renal Cell Carcinoma
Brief Summary: This multicenter, randomized, open-label study will evaluate the efficacy, safety and tolerability of atezolizumab as monotherapy or in combination with bevacizumab versus sunitinib in participants with histologically confirmed, inoperable, locally advanced or metastatic renal cell carcinoma who have not received prior systemic therapy either in the adjuvant or metastatic setting.


Options:
A: Percentage of Participants With Disease Progression Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Via Independent Review Committee (IRC) Assessment or Death in Intent-to-Treat (ITT) Population (From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)); Progression-Free Survival (PFS) Per RECIST v1.1 Via IRC Assessment in ITT Population (From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)); Percentage of Participants With Disease Progression Per RECIST v1.1 Via IRC Assessment or Death in Immune Cell 1/2/3 (IC1/2/3) Population (From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)); PFS Per RECIST v1.1 Via IRC Assessment in IC1/2/3 Population (From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years))
B: Progression Free Survival First-Line (PFS 1-L) (based on radiological assessments every 3 months until disease progression, start of another antineoplastic therapy or for any other reason up to 35 months)
C: Progression-Free Survival (PFS) (Baseline up to 24 Months)
D: Treatment failure rate (progressive disease, treatment withdrawal due to unacceptable toxicities, or any death) (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Combining Cabergoline and Coasting in Gonadotropin Releasing Hormone(GnRH)Agonist Protocol in Intracytoplasmic Sperm Injection (ICSI) to Prevent Ovarian Hyperstimulation Syndrome (OHSS): a Randomized Clinical Trial
Brief Summary: The effectiveness of cabergoline to prevent moderate-severe OHSS to coasting.


Options:
A: Rate and degree of OHSS (composite outcome) (14 days)
B: Moderate or severe ovarian hyperstimulation syndrome (Within 4 weeks of HCG adminstration)
C: risk of ovarian hyperstimulation syndrome (12 days)
D: OHSS (41 days after hCG injection)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Randomized, Multicenter Study to Evaluate the Safety and Efficacy of Evolocumab, Compared With Ezetimibe, in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor Due to Muscle Related Side Effects
Brief Summary: The primary objective of this study was to evaluate the effect of 24 weeks of evolocumab administered subcutaneously (SC) every month, compared with ezetimibe, on low-density lipoprotein cholesterol (LDL-C) levels in adults with high cholesterol who are unable to tolerate an effective dose of a statin due to muscle-related side effects (MRSE).


Options:
A: Percent Change From Baseline in LDL-C at the Mean of Weeks 22 and 24 (Baseline and weeks 22 and 24); Percent Change From Baseline in LDL-C at Week 24 (Baseline and week 24)
B: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis (From Baseline to Week 24)
C: The incidence of treatment-emergent adverse events in subjects treated with REGN727 or placebo, reported from the administration of study drug on day 1 to the completion of the study on day 106 (106 days)
D: The primary endpoint in the study is the incidence of treatment-emergent adverse events in subjects treated with REGN727 or placebo, reported from the administration of study drug on day 1 to the completion of the study on day 106. (106 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Randomized, Multicenter Study to Evaluate the Safety and Efficacy of Evolocumab, Compared With Ezetimibe, in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor Due to Muscle Related Side Effects
Brief Summary: The primary objective of this study was to evaluate the effect of 24 weeks of evolocumab administered subcutaneously (SC) every month, compared with ezetimibe, on low-density lipoprotein cholesterol (LDL-C) levels in adults with high cholesterol who are unable to tolerate an effective dose of a statin due to muscle-related side effects (MRSE).


Options:
A: Percent Change From Baseline in LDL-C at the Mean of Weeks 22 and 24 (Baseline and weeks 22 and 24); Percent Change From Baseline in LDL-C at Week 24 (Baseline and week 24)
B: Time to First Occurrence of Cardiovascular Death, Major Coronary Event, or Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event) (Up to approximately 9 years)
C: Percent Change From Baseline in Calculated LDL-C at Week 24 - ITT Analysis (From Baseline to Week 52)
D: Assessment of the serum concentrations of alirocumab SAR236553 (REGN727) after a single subcutaneous administration at 3 different injection sites in healthy subjects as a measure of the pharmacokinetics of this investigational medicinal product. (Up to 12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2a Double-Blind Placebo-Controlled 2-Period Crossover Study to Evaluate the Safety and Efficacy of BCX4161 as a Prophylactic Treatment to Reduce the Frequency of Attacks in Subjects With Hereditary Angioedema
Brief Summary: The purpose of this study is to determine whether BCX4161 given as a daily oral prophylactic treatment is safe and effective in reducing the number of acute attacks in patients with hereditary angioedema.


Options:
A: Number of acute angioedema attacks (Over 28 days of treatment)
B: Time to Beginning of Substantial Relief of the Defining Symptom (Within 4 hours after initial treatment)
C: Person-time Incidence Rates (Subject Based) (Up to 146 weeks.); The Person-time Incidence Rates (Event Based) (Up to 146 weeks.)
D: The mean acute angioedema attack rate (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness and Cost-effectiveness of Telemedicine for Chronic Obstructive Pulmonary Disease: The Danish "TeleCare North" Pragmatic Cluster-randomized Trial.
Brief Summary: There are two main aims in this study. The first objective is to evaluate whether a particular telehealth solution, in addition to standard treatment and care, lead to a significant decrease in the mortality and an increase in health related quality of life for patients suffering from COPD that may benefit from telehealth compared with only standard treatment and care. The second objective is to examine the additional costs of the telehealth solution and assess whether this solution is a cost-effective way to care for patients with COPD across patients and municipality districts.

It is hypothesized that telehealth care will increase patients quality adjusted life years at both the cluster and individual level compared to usual practice, since no difference in mortality and a higher health related quality of life is expected. Furthermore, it is hoped that there will be a 30% reduction in the number of admissions and readmissions to hospitals and a 30% reduction in the number of outpatient visits resulting in fewer costs for hospitals. However, it is uncertain as to whether these savings are offset by other costs such as more visits to general practitioners, community care or the implementation costs.


Options:
A: AECOPD-related hospital admissions (For a period of 12 months post randomisation)
B: Follow-up with primary care provider (90 days)
C: Health related quality of life (12 month follow-up); Incremental cost-effectiveness ratio (ICER) (12 month follow-up)
D: Chronic Obstructive Pulmonary Disease Self-Efficacy Scale (from baseline and at the end of the third months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness and Cost-effectiveness of Telemedicine for Chronic Obstructive Pulmonary Disease: The Danish "TeleCare North" Pragmatic Cluster-randomized Trial.
Brief Summary: There are two main aims in this study. The first objective is to evaluate whether a particular telehealth solution, in addition to standard treatment and care, lead to a significant decrease in the mortality and an increase in health related quality of life for patients suffering from COPD that may benefit from telehealth compared with only standard treatment and care. The second objective is to examine the additional costs of the telehealth solution and assess whether this solution is a cost-effective way to care for patients with COPD across patients and municipality districts.

It is hypothesized that telehealth care will increase patients quality adjusted life years at both the cluster and individual level compared to usual practice, since no difference in mortality and a higher health related quality of life is expected. Furthermore, it is hoped that there will be a 30% reduction in the number of admissions and readmissions to hospitals and a 30% reduction in the number of outpatient visits resulting in fewer costs for hospitals. However, it is uncertain as to whether these savings are offset by other costs such as more visits to general practitioners, community care or the implementation costs.


Options:
A: Health related quality of life (12 month follow-up); Incremental cost-effectiveness ratio (ICER) (12 month follow-up)
B: 30 day readmission rate (30 days)
C: Dyspnea with ADL (3, 6, and 12 months); Exercise and functional performance (3, 6, and 12 months); Exercise adherence (3, 6, and 12 months); Acute COPD exacerbations (3, 6, and 12 months)
D: Daily number of steps (changes from baseline to 3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness and Cost-effectiveness of Telemedicine for Chronic Obstructive Pulmonary Disease: The Danish "TeleCare North" Pragmatic Cluster-randomized Trial.
Brief Summary: There are two main aims in this study. The first objective is to evaluate whether a particular telehealth solution, in addition to standard treatment and care, lead to a significant decrease in the mortality and an increase in health related quality of life for patients suffering from COPD that may benefit from telehealth compared with only standard treatment and care. The second objective is to examine the additional costs of the telehealth solution and assess whether this solution is a cost-effective way to care for patients with COPD across patients and municipality districts.

It is hypothesized that telehealth care will increase patients quality adjusted life years at both the cluster and individual level compared to usual practice, since no difference in mortality and a higher health related quality of life is expected. Furthermore, it is hoped that there will be a 30% reduction in the number of admissions and readmissions to hospitals and a 30% reduction in the number of outpatient visits resulting in fewer costs for hospitals. However, it is uncertain as to whether these savings are offset by other costs such as more visits to general practitioners, community care or the implementation costs.


Options:
A: Health related quality of life (12 month follow-up); Incremental cost-effectiveness ratio (ICER) (12 month follow-up)
B: Number of Participants with Hospital Readmission at 6 months (6 months)
C: Change in Adherence of each participant (3 months, 6 months and 12 months); Change in Adherence of each participant (3 months, 6 months and 12 months); Change in Adherence of each participant (3 months, 6 months and 12 months); Change in Adherence of each participant (3 months, 6 months and 12 months)
D: Patient's perception of the variability of symptoms due to severe stable state COPD throughout the day, the week and the year (Once)

Answer: A