TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Intravitreous Anti-VEGF vs. Prompt Vitrectomy for Vitreous Hemorrhage From Proliferative Diabetic Retinopathy
Brief Summary: Although vitreous hemorrhage (VH) from proliferative diabetic retinopathy (PDR) can cause acute and dramatic vision loss for patients with diabetes, there is no current, evidence-based clinical guidance as to what treatment method is most likely to provide the best visual outcomes once intervention is desired. Intravitreous anti-vascular endothelial growth factor (anti-VEGF) therapy alone or vitrectomy combined with intraoperative PRP each provide the opportunity to stabilize or regress retinal neovascularization. However, clinical trials are lacking to elucidate the relative time frame of visual recovery or final visual outcome in prompt vitrectomy compared with initial anti-VEGF treatment. The Diabetic Retinopathy Clinical Research Network Protocol N demonstrated short-term trends consistent with a possible beneficial effect of anti-VEGF treatment in eyes with VH from PDR, including greater visual acuity improvement and reduced rates of recurrent VH as compared with saline injection. It is possible that a study with a longer duration of follow-up with structured anti-VEGF retreatment would demonstrate even greater effectiveness of anti-VEGF for VH to avoid vitrectomy and its attendant adverse events while also improving visual acuity. On the other hand, advances in surgical techniques leading to faster operative times, quicker patient recovery, and reduced complication rates may make prompt vitrectomy a more attractive alternative since it results in the immediate ability to clear hemorrhage and to perform PRP if desired, often as part of one procedure. This proposed study will evaluate the safety and efficacy of two treatment approaches for eyes with VH from PDR: prompt vitrectomy + PRP and intravitreous aflibercept injections.


Options:
A: N/A
B: E-ETDRS Visual Acuity Letter Score (Area Under the Curve From Baseline) (24 weeks)
C: amount of intraoperative intra-ocular bleeding (three weeks)
D: Mean best corrected visual acuity(BCVA) change in both groups. (9 months follow up.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Intravitreous Anti-VEGF vs. Prompt Vitrectomy for Vitreous Hemorrhage From Proliferative Diabetic Retinopathy
Brief Summary: Although vitreous hemorrhage (VH) from proliferative diabetic retinopathy (PDR) can cause acute and dramatic vision loss for patients with diabetes, there is no current, evidence-based clinical guidance as to what treatment method is most likely to provide the best visual outcomes once intervention is desired. Intravitreous anti-vascular endothelial growth factor (anti-VEGF) therapy alone or vitrectomy combined with intraoperative PRP each provide the opportunity to stabilize or regress retinal neovascularization. However, clinical trials are lacking to elucidate the relative time frame of visual recovery or final visual outcome in prompt vitrectomy compared with initial anti-VEGF treatment. The Diabetic Retinopathy Clinical Research Network Protocol N demonstrated short-term trends consistent with a possible beneficial effect of anti-VEGF treatment in eyes with VH from PDR, including greater visual acuity improvement and reduced rates of recurrent VH as compared with saline injection. It is possible that a study with a longer duration of follow-up with structured anti-VEGF retreatment would demonstrate even greater effectiveness of anti-VEGF for VH to avoid vitrectomy and its attendant adverse events while also improving visual acuity. On the other hand, advances in surgical techniques leading to faster operative times, quicker patient recovery, and reduced complication rates may make prompt vitrectomy a more attractive alternative since it results in the immediate ability to clear hemorrhage and to perform PRP if desired, often as part of one procedure. This proposed study will evaluate the safety and efficacy of two treatment approaches for eyes with VH from PDR: prompt vitrectomy + PRP and intravitreous aflibercept injections.


Options:
A: Mean Change in Visual Acuity From Baseline (2-years)
B: E-ETDRS Visual Acuity Letter Score (Area Under the Curve From Baseline) (24 weeks)
C: N/A
D: Mean Change From Baseline in BCVA Letter Score at Week 24, in Treatment-Naive Participants (Baseline, Week 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: SURV1VE-Trial - Sustained Inflation and Chest Compression Versus 3:1 Chest Compression to Ventilation Ratio During Cardiopulmonary Resuscitation of Asphyxiated Newborns: A Randomized Controlled Trial
Brief Summary: Research question In newborn infants requiring CPR, does CC superimposed by sustained inflation compared to 3:1 compression to ventilation ratio improves return of spontaneous circulation?

Overall objective: CC superimposed by sustained inflation will improve short- and long-term outcomes in preterm (\>28 weeks or older) and term newborns.

Hypothesis to be tested Primary hypothesis: By using CC superimposed by sustained inflation (CC+SI) during CPR the time needed to achieve return of spontaneous circulation (ROSC) compared to the current 3:1 compression to ventilation (C:V) will be reduced in asphyxiated newborns.


Options:
A: Difference in bronchopulmonary dysplasia (36 weeks corrected gestational age)
B: Combined Outcome of Death or Bronchopulmonary Dysplasia (36 weeks)
C: Time Needed to Achieve Return of Spontaneous Circulation (within the first 10 minutes after birth)
D: Return of Spontaneous Circulation (up to 60 Minutes of chest compression)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Two-Part, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Intravenous CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
Brief Summary: 2 Part Study: Part A will assess 3 different dosing levels of IV CR845 versus placebo in patient on hemodialysis who have moderate-to-severe itching due to uremic pruritus. Patients will receive either CR845 or placebo after each dialysis session for eight weeks. The safety and efficacy of CR845 will be monitored throughout the study. A sub-group of patients will also have pharmacokinetic assessments completed. Part B of the study will assess one dose of IVCR845 versus placebo for 12 weeks in patients on hemodialysis who have moderate-to-severe itching. The dose of CR845 used in Part B will be based on safety and efficacy found in Part A.


Options:
A: the longitudinal changes of itching (every week, up to 12 weeks.)
B: Primary efficacy endpoint is the change in worst itching intensity from baseline, compared to that in the last two weeks of the double blind, placebo controlled, randomized withdrawal period. (11 weeks)
C: Reduction of UP by more than 50% after Pregabalin administration (2012)
D: Change From Baseline in the Weekly Mean of the Daily 24-hour Worst Itching Intensity NRS Score During Week 8 (Baseline, Week 8)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Randomised, Open Label Study of Neoadjuvant Dabrafenib, Trametinib and / or Pembrolizumab in BRAF V600 Mutant Resectable Stage IIIB/C Melanoma
Brief Summary: This study aims to determine which of 3 drug combinations best reduces the size of tumour prior to surgery for advanced melanoma and prevents the recurrence of melanoma after surgery.


Options:
A: Pathological response rate (From baseline to 6 weeks)
B: The feasibility of treating patients with unresectable melanoma and palpable lymph node metastases that harbor the BRAF mutation with neoadjuvant vemurafenib. (24 months)
C: Recurrence-free survival (RFS) rate (1 year after randomization)
D: The alteration in magnitude of the neo-antigen specific T cell response in the time interval pre- to post-adjuvant therapy in peripheral blood (12 weeks from baseline); Safety as measured by SUSARs. (12 weeks from baseline); The alteration in breadth of the neo-antigen specific T cell response in the time interval pre- to post-adjuvant therapy in peripheral blood (12 weeks from baseline); Feasibility as measured adherence to the timelines in the study protocol. (12 weeks from baseline)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Randomised, Open Label Study of Neoadjuvant Dabrafenib, Trametinib and / or Pembrolizumab in BRAF V600 Mutant Resectable Stage IIIB/C Melanoma
Brief Summary: This study aims to determine which of 3 drug combinations best reduces the size of tumour prior to surgery for advanced melanoma and prevents the recurrence of melanoma after surgery.


Options:
A: The immune response disease control rate (irDCR) using the immune-related (ir) tumor response criteria of the combination of ipilimumab and fotemustine in patients with unresectable locally advanced or metastatic melanoma. (Weeks 24)
B: Number of Participants With BRAF V600E Mutation-positive Melanoma With Overall Intracranial Response (OIR), as Assessed by the Investigator (From the time of the Baseline assessment until disease progression or end of study treatment (average of 18.3 weeks))
C: Pathological response rate (From baseline to 6 weeks)
D: Progression-free Survival (PFS) as Assessed by the Investigator (Time interval between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause (up to 9.9 months)); Progression-free Survival (PFS) as Assessed by an Independent Radiologist: Randomized Phase (Time interval between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause (up to 9.9 months))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Augmentation of Patch Outcomes in Heavy Drinkers' Smoking Cessation
Brief Summary: The purpose of this study is to learn if the combination of a study drug and patch is more effective in helping heavy drinkers stop smoking than just the patch alone The study drug, varenicline, has been approved by the Food and Drug Administration (FDA) to help people stop smoking, but it is not known if the addition of varenicline to standard smoking cessation treatment with nicotine patches will help people stop smoking who are regular, frequent drinkers. This study is being done because cigarette smoking is the number one preventable cause of death and disease in the United States.


Options:
A: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12
B: Change From Baseline Smoking Abstinence Rates at 12 Weeks (12 weeks)
C: Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period
D: Continuous smoking abstinence rate (Weeks 9 to 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness and Cost-effectiveness of Telemedicine for Heart Failure: The Danish "TeleCare North" Pragmatic 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 Heart Failure 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 Heart Failure across patients and municipality districts.

It is hypothesized that telehealth care will increase patients quality adjusted life years 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: Change in dietary and physical activity behavior (self-report) (Baseline to 8 weeks later)
B: Mental health related quality of life (SF-36 questionnaire mental scores) (12 month follow-up); Incremental cost-effectiveness ratio (ICER) (12 month follow-up)
C: Improvement tolerance capacity (4 months and 6 months)
D: days alive and out of hospital (up to 2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Evaluation of Use of Prismocitrate 18 in Patients Undergoing Acute Continuous Renal Replacement Therapy (CRRT)
Brief Summary: The purpose of this research is to determine if an investigational new drug solution called Prismocitrate 18 lengthens extracorporeal circuit life in patients treated with continuous renal replacement therapy (CRRT). Patients who receive CRRT treatment with Prismocitrate 18 as the anticoagulant will be compared to patients who receive CRRT treatment with no anticoagulation.


Options:
A: Time to Occurrence of Selected Prismaflex® System Alarms/Conditions (Up to 120 hours post CRRT treatment initiation)
B: CRRT-filter life span in hours (during continuous renal replacement therapy up to 1 year); Overall survival in a 90day follow-up period (90 days)
C: Technical CRRT efficiency (72 hours)
D: Middle molecular weight molecules clearances (18 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Evaluation of Use of Prismocitrate 18 in Patients Undergoing Acute Continuous Renal Replacement Therapy (CRRT)
Brief Summary: The purpose of this research is to determine if an investigational new drug solution called Prismocitrate 18 lengthens extracorporeal circuit life in patients treated with continuous renal replacement therapy (CRRT). Patients who receive CRRT treatment with Prismocitrate 18 as the anticoagulant will be compared to patients who receive CRRT treatment with no anticoagulation.


Options:
A: Time to Occurrence of Selected Prismaflex® System Alarms/Conditions (Up to 120 hours post CRRT treatment initiation)
B: Mean running time of a maximum of two consecutive haemodialysis circuits (seven days starting at time of HIT suspicion)
C: mortality (2 years)
D: CRRT-filter life span in hours (during continuous renal replacement therapy up to 1 year); Overall survival in a 90day follow-up period (90 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Evaluation of Use of Prismocitrate 18 in Patients Undergoing Acute Continuous Renal Replacement Therapy (CRRT)
Brief Summary: The purpose of this research is to determine if an investigational new drug solution called Prismocitrate 18 lengthens extracorporeal circuit life in patients treated with continuous renal replacement therapy (CRRT). Patients who receive CRRT treatment with Prismocitrate 18 as the anticoagulant will be compared to patients who receive CRRT treatment with no anticoagulation.


Options:
A: Mg balance of CVVH treatment (1 month)
B: Mean running time of a maximum of two consecutive haemodialysis circuits (seven days starting at time of HIT suspicion)
C: Duration of event-free survival of the first non-tunneled hemodialysis catheter (defined at the time in days from catheter insertion to withdrawal whatever the reason) (up to 28 days)
D: Time to Occurrence of Selected Prismaflex® System Alarms/Conditions (Up to 120 hours post CRRT treatment initiation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Depressive Symptoms Among Rural African Americans
Brief Summary: Rural African Americans are disproportionately impacted by social stressors that place them at risk for experiencing elevated depressive symptoms. This project will test the effectiveness of a culturally adapted behavioral activation intervention (REJOICE) for use within rural African American churches. Further, this project will gather data on strategies necessary to promote the successful implementation of this intervention within rural African American churches.


Options:
A: PHQ9 Depression Score (3 months post-partm)
B: Change from baseline in Patient Health Questionnaire (PHQ-9) (Weekly during treatment period of 12 weeks); Change from baseline in Patient Health Questionnaire (PHQ-9) (24 hours); Change from baseline in Patient Health Questionnaire (PHQ-9) (12 months); Change from baseline in Patient Health Questionnaire (PHQ-9) (24 months); Change from baseline in Patient Health Questionnaire (PHQ-9) (Monthly, 0-24 months)
C: Patient Health Questionnaire (PHQ-9)- Change from baseline (Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment); Beck Depression Inventory (BDI)- Change from baseline (Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment)
D: Depressive Symptoms - Beck Depression Inventory (BDI-II) (Immediately upon completion of 8 week intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Nursing Home Team-Care Deprescribing Study
Brief Summary: This is a multi-centre study in Singapore nursing homes, investigating the factors that affecting deprescribing, and if a team-care based deprescribing standard practice gives superior health and pharmacoeconomic outcomes over current medication review practice.


Options:
A: Change from baseline in Fall Risk Assessment Tool (FRAT) score (Change from baseline in FRAT score at 3 months); Change from baseline in Fall Risk Assessment Tool (FRAT) score (Change from baseline in FRAT score at 6 months); Change from baseline in Fall Risk Assessment Tool (FRAT) score (Change from baseline in FRAT score at 12 months); Change from baseline in fall rate (Change from baseline in fall rate at 3 months); Change from baseline in fall rate (Change from baseline in fall rate at 6 months); Change from baseline in fall rate (Change from baseline in fall rate at 12 months)
B: The primary outcome measure will be the "improvement" of prescribing for efficacious therapies in patients with a chronic cardiovascular disease within six months of the intervention.
C: Medication adherence; Exacerbation of heart failure; Health-related quality of life
D: Health-related quality of life (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Nursing Home Team-Care Deprescribing Study
Brief Summary: This is a multi-centre study in Singapore nursing homes, investigating the factors that affecting deprescribing, and if a team-care based deprescribing standard practice gives superior health and pharmacoeconomic outcomes over current medication review practice.


Options:
A: N/A
B: Successful medication discontinuation (4 months)
C: Health-related quality of life as measured with 15D (16 weeks)
D: Change from baseline in Fall Risk Assessment Tool (FRAT) score (Change from baseline in FRAT score at 3 months); Change from baseline in Fall Risk Assessment Tool (FRAT) score (Change from baseline in FRAT score at 6 months); Change from baseline in Fall Risk Assessment Tool (FRAT) score (Change from baseline in FRAT score at 12 months); Change from baseline in fall rate (Change from baseline in fall rate at 3 months); Change from baseline in fall rate (Change from baseline in fall rate at 6 months); Change from baseline in fall rate (Change from baseline in fall rate at 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: COMRADE: Collaborative Care Management for Distress and Depression in Rural Diabetes
Brief Summary: The study will implement and evaluate, using a pragmatic comparative effectiveness trial, a unique collaborative, stepped-care intervention for patients with uncontrolled Type 2 diabetes and co-morbid distress and/or depression.


Options:
A: Qualitative description of process-related challenges and successes as assessed by observation and survey (3 months)
B: First occurrence of fatal or non-fatal acute MI, unstable angina, stroke, congestive heart failure, or revascularization (coronary bypass, stent insertion, or angioplasty) (2.5 years)
C: Care Transition Measure-3 score (CTM-3) (30-days post discharge)
D: Change From Baseline in Glycosylated Hemoglobin (%) (Baseline to 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: COMRADE: Collaborative Care Management for Distress and Depression in Rural Diabetes
Brief Summary: The study will implement and evaluate, using a pragmatic comparative effectiveness trial, a unique collaborative, stepped-care intervention for patients with uncontrolled Type 2 diabetes and co-morbid distress and/or depression.


Options:
A: Death or non-fatal myocardial infarction (Up to 10 months)
B: Change From Baseline in Glycosylated Hemoglobin (%) (Baseline to 12 months)
C: HbA1c (Last measurement within 12 months before - and 15 months after nurse participation in the course)
D: Glycemic relapse: increase in HbA1c by 1% over baseline and >8%

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I/II Prospective, Randomized, Multicenter, Double-Masked, Vehicle-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Corneal Collagen Cross-Linking of Keratoprosthesis Carrier Tissue in High-Risk Keratoprosthesis Implantation
Brief Summary: This is a phase I/II prospective, randomized, multi-center, double-masked, vehicle-controlled clinical trial evaluating the safety and efficacy of corneal collagen cross-linking the keratoprosthesis carrier tissue in subjects who are candidates for high-risk keratoprosthesis implantation but because of a history of corneal melts or autoimmune diseases are not candidate for a traditional corneal transplant.


Options:
A: Healing (Three months)
B: Microbiological Cure on Repeat Culture (4 to 24 hours after enrollment)
C: Time to Re-epithelialization (Day 1, day 2, day 3, day 4, day 5, day 6, day 7, week 2, and subsequent weekly assessments until re-epithelialization is complete)
D: Time From Surgery to Device Loss or Replacement (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Hospitalization at Home Pilot: The Acute Care Home Hospital Program for Adults
Brief Summary: The investigators propose a home hospital model of care that substitutes for treatment in an acute care hospital. Limited studies of the home hospital model have demonstrated that a sizeable proportion of acute care can be delivered in the home with equal quality and safety, reduced cost, and improved patient experience.


Options:
A: Walking time in daily life and the amount of time spent in moderate intense activities
B: Dyspnea (Chronic Respiratory Questionnaire (CRQ) domain) (Change from baseline to 12 months)
C: Change from baseline of time spent in at least moderate physical activity (3>METS equivalent) (8 weeks)
D: Total cost of hospitalization, $ (Day of admission to day of discharge)

Answer: D