TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Physical Training Program in Patients Hospitalized for Community-acquired Pneumonia
Brief Summary: Hospitalized patients with community-acquired pneumonia (CAP) have reduced functional capacity, peripheral muscle strength and quality of life. Despite the high incidence and severity has not yet been demonstrated whether a physical training program can change these outcomes. Objectives: To evaluate the effects of an exercise training program in patients hospitalized for CAP, to compare this effects with traditional physical therapy and assess whether the inflammatory markers correlate with the functional status of the patient and type of treatment. Methods: A controlled, prospective, randomized clinical trial. Patients hospitalized for CAP, adults, conscious, hemodynamically stable and independent to walk will be studied. In the first day, a medical history, measured dyspnea, incremental shuttle walk test, Glittre test, measurement of peripheral muscle strength, spirometry, and the application of quality of life questionnaire Shor Form 36 will be held. The measurement of inflammatory markers (C-reactive protein and tumor necrosis factor) will also be held. Patients will be randomized into two groups: one will perform a program of physical training (stretching, active resistance exercises and aerobic exercises) and the other group held the traditional physical therapy (bronchial hygiene, breathing exercises and walking) for eight days. On the tenth day the same assessment will be carried out initially described.


Options:
A: Glittre test (up to 9 months)
B: Muscle strength (Participants will be followed for the duration of hospital stay, an expected average of 8 days); Exercise capacity (Participants will be followed for the duration of hospital stay, an expected average of 8 days)
C: treatment failure at 72h after initiation of antibiotics (Time from the first dose use of antibiotics to 72 hours); in-hospital treatment failure due to multiple causes (Time from date of admission to discharge up to 1 week)
D: Change in adventitious lung sounds (24 hours after hospital presentation (baseline) and 3 weeks after intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections With Pseudomonas Aeruginosa in Patients With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label Extension
Brief Summary: This study (ARD-3150-1202, ORBIT-4) will evaluate the safety and efficacy of inhaled Pulmaquin (ciprofloxacin dispersion for inhalation) compared to inhaled placebo in subjects who have a confirmed diagnosis of non-cystic fibrosis (non-CF) bronchiectasis with a history of pulmonary exacerbations and chronic P. aeruginosa infections.


Options:
A: Time to First Exacerbation Event Within 48 Weeks - Cipro 28 vs. Pooled Placebo (Up to Week 48); Time to First Exacerbation Event Within 48 Weeks - Cipro 14 vs. Pooled Placebo (Up to Week 48)
B: Change in QOL-B Respiratory Symptoms Score at Day 28 (Baseline to Day 28)
C: Change in QOL-B Respiratory Symptoms Score at Day 28 (Baseline to Day 28)
D: Time to first pulmonary exacerbation (from baseline) (48 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This research represents a randomized trial of a program to improve timely postnatal care, comparing post-natal check-ups performed by community health workers delivered either by phone or in person to a control group. The study hypothesis is that when community health workers check on women three days after their delivery we will see improvements in the detection of maternal and child complications, better knowledge of complications and an increase in behaviors that are expected to lead to improved maternal and child health.


Options:
A: Postpartum Clinic Attendance (assessed at 12 weeks postpartum)
B: DSS Investigated and Substantiated Child Maltreatment Rates (0 - 12 Years of Child Age)
C: Complications detected (3 days after delivery); Successful referrals (10 days after delivery (survey and administrative records)); Care Seeking Behavior around complications and well baby check-up (10 days after delivery (survey)); Knowledge of danger signs (10 days after delivery (survey)); Breastfeeding (10 days and 9 weeks after delivery (survey))
D: Use of unplanned maternal and child healthcare services (inpatient, Emergency Department (ED), urgent/acute care, primary care, and mental health) in the first 14 days after delivery (3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This research represents a randomized trial of a program to improve timely postnatal care, comparing post-natal check-ups performed by community health workers delivered either by phone or in person to a control group. The study hypothesis is that when community health workers check on women three days after their delivery we will see improvements in the detection of maternal and child complications, better knowledge of complications and an increase in behaviors that are expected to lead to improved maternal and child health.


Options:
A: Sexually transmitted disease (Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum); Rapid repeat pregnancy (Measured at Month 12 postpartum); Sexual risk behavior (Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum); Perinatal outcomes (e.g., birth weight, gestational age) (Measured at Months 6 and 12 postpartum)
B: Neurodevelopment as measured by the Protocol for Child Monitoring - Infant and Toddler version assessment (12 months of age)
C: delayed bathing of baby (24 months)
D: Complications detected (3 days after delivery); Successful referrals (10 days after delivery (survey and administrative records)); Care Seeking Behavior around complications and well baby check-up (10 days after delivery (survey)); Knowledge of danger signs (10 days after delivery (survey)); Breastfeeding (10 days and 9 weeks after delivery (survey))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This research represents a randomized trial of a program to improve timely postnatal care, comparing post-natal check-ups performed by community health workers delivered either by phone or in person to a control group. The study hypothesis is that when community health workers check on women three days after their delivery we will see improvements in the detection of maternal and child complications, better knowledge of complications and an increase in behaviors that are expected to lead to improved maternal and child health.


Options:
A: ANC (Assess the recommend number of ANC (4 ANC) coverage 18 months after intervention); PNC (Assess the recommend number of PNC (3 ANC) coverage 18 months after intervention); Contraceptive prevalence rate (CPR) (Assess the Contraceptive prevalence rate (CPR) at the end of intervention of 18 months.); EPI coverage (Assess the EPI vaccination coverage at the end of the intervention of 18 months)
B: Short-term Exclusive Breastfeeding (24-hour recall) (Measured at 1 month post-delivery via tablet based survey AND independent verification phone survey within one week); Long-term Exclusive Breastfeeding (24-hour recall) (Measured at 5 months post-delivery via tablet based survey AND independent verification phone survey within one week)
C: the first aim is to assess our ability to enroll at least 70% (N=90) of eligible parents in a text messaging program (up to 1 year)
D: Complications detected (3 days after delivery); Successful referrals (10 days after delivery (survey and administrative records)); Care Seeking Behavior around complications and well baby check-up (10 days after delivery (survey)); Knowledge of danger signs (10 days after delivery (survey)); Breastfeeding (10 days and 9 weeks after delivery (survey))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This research represents a randomized trial of a program to improve timely postnatal care, comparing post-natal check-ups performed by community health workers delivered either by phone or in person to a control group. The study hypothesis is that when community health workers check on women three days after their delivery we will see improvements in the detection of maternal and child complications, better knowledge of complications and an increase in behaviors that are expected to lead to improved maternal and child health.


Options:
A: Complications detected (3 days after delivery); Successful referrals (10 days after delivery (survey and administrative records)); Care Seeking Behavior around complications and well baby check-up (10 days after delivery (survey)); Knowledge of danger signs (10 days after delivery (survey)); Breastfeeding (10 days and 9 weeks after delivery (survey))
B: Linkage to HIV Care (Indicated by a HIV-related Laboratory Blood Test Within 8 Months) (Recruitment +8 months)
C: the first aim is to assess our ability to enroll at least 70% (N=90) of eligible parents in a text messaging program (up to 1 year)
D: Influenza Immunization: Pediatric (March 31, 2011); Influenza Immunization: Pregnant Women (by December 31, 2011); Influenza Immunization: Delayed Pediatric (March 31, 2012)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Long-Term Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh Cardiovascular Risk PatienTs With Hypertriglyceridemia (STRENGTH)
Brief Summary: The study is a randomized, double-blind, placebo-controlled (corn oil), parallel group design that will enroll approximately 13,000 patients with hypertriglyceridemia and low HDL and high risk for CVD to be randomized 1:1 to either corn oil + statin or Epanova + statin, once daily, for approximately 3-5 years as determined when the number of MACE outcomes is reached.


Options:
A: The primary objective is to compare the carotid plaque stability after placebo versus Omega-3 fatty acid treatment by assessing structural changes associated with plaque rupture and instability. The composite endpoint includes changes in; (1) the size of the lipid pool,; (2) the number of foam cells,; (3) the presence of haemorrhage,; (4) the number of macrophages in lesions and; (5) the overall density of inflammation in the plaque as a whole and; (6) in fibrous caps of lesions.
B: The Composite of Major Adverse Cardiovascular Events (MACE) (From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure)
C: modified Rankin scale (mRS) 0-1 (favourable outcome) at Day 90 (at day 90)
D: Major coronary events (sudden cardiac death, fatal and nonfatal myocardial infarction, unstable angina pectoris including hospitalization for ischemic episodes,events of angioplasty/ stenting or coronary artery bypass grafting)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Phase 3 Trial Of Accelerated Partial Breast Irradiation Using Intensity Modulated Radiotherapy Versus Whole Breast Irradiation
Brief Summary: The aim of this Phase 3 randomised trial is to compare the efficacy and safety of whole breast radiotherapy to accelerated partial breast irradiation using intensity-modulated radiotherapy technique in selected early breast cancer patients after breast conserving surgery.


Options:
A: Ipsilateral Breast Tumor Recurrence (5-year)
B: Local control (5-years, 10 ten-years)
C: Number of local relapses (5 YEARS)
D: Local relapse within the treated breast. (3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 72, 84, 96, 108, 120 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Phase 3 Trial Of Accelerated Partial Breast Irradiation Using Intensity Modulated Radiotherapy Versus Whole Breast Irradiation
Brief Summary: The aim of this Phase 3 randomised trial is to compare the efficacy and safety of whole breast radiotherapy to accelerated partial breast irradiation using intensity-modulated radiotherapy technique in selected early breast cancer patients after breast conserving surgery.


Options:
A: Local relapse within the treated breast. (3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 72, 84, 96, 108, 120 months)
B: Number of local relapses (5 YEARS)
C: Local control (5-years, 10 ten-years)
D: Ipsilateral Breast Tumor Recurrence (5-year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Case Series Clinical Study of the Reversal of the Anticoagulant Effects of Dabigatran by Intravenous Administration of 5.0g Idarucizumab (BI 655075) in Patients Treated Wtih Dabigatran Etexilate Who Have Uncontrolled Bleeding or Require Emergency Surgery or Procedures.RE-VERSE AD (A Study of the RE-VERSal Effects of Idarucizumab on Active Dabigatran) Trial
Brief Summary: Evaluate the reversal of the anticoagulant effects of dabigatran by IV administration of 5.0g idarucizumab in patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures.


Options:
A: Co-primary endpoints of Major Adverse Cardiovascular Events (MACE) and major bleeding (12 months)
B: Event Rate of All-Cause Mortality, Myocardial Infarction (MI), or Stroke (Up to Global treatment end date (approximately 54 months)); Event Rate of Either Fatal Bleeding or Bleeding Into a Critical Space With Potential for Permanent Disability (Up to 227 Weeks)
C: Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of dTT or ECT (from the end of the first infusion up to 4 hours after the last infusion on Day 1)
D: Number of Participants With First Event of Ischemic/Unspecified Stroke, Hemorrhagic Stroke, or Systemic Embolism (SE) During the Intended Treatment Period (Time to first event in "Intended Treatment Period": started on day of randomization, ended at efficacy cut-off date (date target number of primary efficacy events [448] was expected to have occurred; set to 30-Jan-2011, prior to unblinding).); Rate of Adjudicated Stroke or Systemic Embolism (SE) During the Intended Treatment Period ("Intended Treatment Period" started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding).)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Case Series Clinical Study of the Reversal of the Anticoagulant Effects of Dabigatran by Intravenous Administration of 5.0g Idarucizumab (BI 655075) in Patients Treated Wtih Dabigatran Etexilate Who Have Uncontrolled Bleeding or Require Emergency Surgery or Procedures.RE-VERSE AD (A Study of the RE-VERSal Effects of Idarucizumab on Active Dabigatran) Trial
Brief Summary: Evaluate the reversal of the anticoagulant effects of dabigatran by IV administration of 5.0g idarucizumab in patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures.


Options:
A: Primary outcome:time to the first occurrence of stroke, non-CNS systemic embolism, myocardial infarction or vascular death (during approximately three years of follow-up)
B: Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Superiority for Composite of Stroke and Systemic Embolic Events (SEE). (overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up)
C: Time to First Adjudicated ISTH MBE or CRNMBE (up to 30 months)
D: Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of dTT or ECT (from the end of the first infusion up to 4 hours after the last infusion on Day 1)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Delivery of Patient-Centered Cardiac Rehabilitation
Brief Summary: The long-term goal of this research is to improve patient-centered outcomes in patients with coronary heart disease (CHD), the leading cause of death in the world. Exercise-based cardiac rehabilitation (CR) programs decrease mortality and improve quality of life in patients with CHD. Published guidelines recommend exercise-based CR following hospitalization for myocardial infarction, coronary artery bypass grafting, or percutaneous coronary revascularization.

Despite these compelling benefits, CR programs are vastly underutilized, with less than a third of eligible patients participating. One promising solution is greater implementation of home-based CR. Both home and center-based CR programs have equal benefits on cardiovascular risk factors and quality of life. However, similar efficacy does not necessarily translate into similar effectiveness. If patients are more likely to participate in home- vs. center-based therapy, then greater participation could lead to greater clinical effectiveness. We are therefore conducting a quasi-experimental, controlled trial at two VA medical centers to determine the comparative effectiveness of referral to home- vs. center-based CR in patients with CHD.

Aim 1: Determine whether automatic referral to home- vs. center-based CR increases patient participation in CR after hospitalization for myocardial infarction or coronary revascularization.

Aim 2: Among patients who choose to participate in CR, compare the effectiveness of home- vs. center-based CR on six-minute walk distance, quality of life, and healthcare expenditures.

Aim 3: Determine whether the effects of home vs. center-based CR differ by age, gender, race, ethnicity, employment, socioeconomic status, social support, comorbid conditions, or patient preference.

Results from this study will (a) help policy makers determine the effect of covering home CR on healthcare expenditures in patients with CHD; (b) help providers understand the potential benefits and harms of home- vs. center-based CR; and (c) help patients answer questions like, "Given my personal circumstances and preferences, which of these options will improve the outcomes most important to me".


Options:
A: Change from baseline peak VO2 (ml/kg/min) at 12 week (Baseline, 12 week); Change from baseline MLHFQ at 12 week (Baseline,12 week)
B: Change in the levels of physical fitness (Baseline, 12 week follow - up (end of intervention), 6 months after the completion of the intervention)
C: Percentage of subjects who completed all tasks in the application. (Baseline to 3 months)
D: Participation in Cardiac Rehabilitation (12 Months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized Study Comparing the Effects of Selective Laser Trabeculoplasty and Travoprost on the Circadian Intraocular Pressure Variation
Brief Summary: The investigators conduct this study to access the effect of selective laser trabeculoplasty on 24-hour circadian tension curves of patients with open-angle glaucoma, normal tension glaucoma and ocular hypertension. This treatment effect is compared with that of the prostaglandin analogue, travoprost.


Options:
A: Change of circadian intraocular pressure (Six weeks after recieving treatment)
B: Intraocular Pressure (12 months post operatively)
C: Intraocular pressure reduction
D: The difference between the two treatment groups between the mean baseline IOP and the mean IOP after the treatment (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Treatment-Naïve Subjects With Chronic HCV GT1, GT4, and GT6 Infection.
Brief Summary: This was an efficacy and safety study of grazoprevir (MK-5172) in combination with elbasvir (MK-8742) in treatment-naive participants with chronic hepatitis C virus (HCV) genotype (GT) 1, 4, or 6 infection. Participants were randomly assigned (3:1 ratio) to immediate treatment or deferred treatment (placebo control). The primary efficacy hypothesis was that the proportion of participants receiving combination therapy in the Immediate Treatment Arm who achieve sustained viral response at 12 weeks after the end of study treatment (SVR12) is superior to 73%.


Options:
A: Number of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels 24 Weeks After Last Planned Dose of Study Treatment (24 weeks after last planned dose of study treatment (up to Week 72))
B: Percentage of Participants Achieving RVR (Week 4); Number of Participants Experiencing an Adverse Event (AE) (Up to Day 42); Number of Participants Discontinuing From Study Therapy Due to AEs (Day 1 to Day 28)
C: Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks After the End of Treatment (SVR12) (Week 24 (12 weeks after the end of treatment)); Percentage of Participants Experiencing at Least One Adverse Event (Up to Week 14 (14 days after the Blinded Treatment was completed)); Percentage of Participants Discontinued From Study Treatment Because of an Adverse Event (Up to Week 12 (end of Blinded Treatment))
D: Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12 (A Weeks 4 and 12)

Answer: C