TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A 28-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center, Study in Recombinant Human Erythropoietin (rhEPO) naïve Non-dialysis Participants With Anemia Associated With Chronic Kidney Disease to Evaluate the Efficacy, Safety and Effects on Quality of Life of Daprodustat Compared to Placebo
Brief Summary: The purpose of this multi-center study in non-dialysis participants with anemia associated with CKD is to evaluate safety, efficacy and quality of life of daprodustat compared to placebo.


Options:
A: Change in hemoglobin (Hb) between Baseline (average pretreatment Hb) and the primary evaluation period (average Hb from Weeks 20 to 26, inclusive) (Baseline; Weeks 20 to 26)
B: Mean Change in Hemoglobin From Baseline and Over the Evaluation Period (Mean Over Week 24 and 28) (Baseline (Day 1) and Week 24 to Week 28)
C: Change from baseline in the average hemoglobin (Hb) (Baseline and Weeks 18 to 24)
D: The mean Hb level during the evaluation period (From week 33 to 36); The change in mean Hb level during the evaluation period from baseline (Baseline and week 33 to 36)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Community-based Assessment of Skin Care, Allergies, and Eczema
Brief Summary: Atopic dermatitis (AD) affects over 9 million children in the U.S. and often heralds the development of asthma, food allergy, skin infections and neurodevelopmental disorders. Recent advances identify skin barrier dysfunction to be the key initiator of AD and possibly allergic sensitization.

Our central hypothesis is that daily emollient use from birth can prevent the development of AD in a community setting and into newborns unselected for risk. The results of a community-based clinical trial utilizing a pragmatic trial design will be immediately applicable to the population at large and will establish a new standard of care for all newborns.


Options:
A: Proportion of eligible families screened who are willing and able to be randomised. (Before birth)
B: Atopic dermatitis (AD) (AD 0-12 months, with follow-up investigations at 2 and 3 yrs and at intervals up to year 2044, provided funding); Food allergy to any intervention allergen (0-36 months, assessed first at 36 months, with follow-up investigations at intervals up to year 2044, provided funding)
C: Presence of eczema (12 months of age.); Confirmed diagnosis of food allergy at 12 months (52 weeks). (12 months of age)
D: Cumulative incidence of provider-diagnosed AD (up to 24 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Community-based Assessment of Skin Care, Allergies, and Eczema
Brief Summary: Atopic dermatitis (AD) affects over 9 million children in the U.S. and often heralds the development of asthma, food allergy, skin infections and neurodevelopmental disorders. Recent advances identify skin barrier dysfunction to be the key initiator of AD and possibly allergic sensitization.

Our central hypothesis is that daily emollient use from birth can prevent the development of AD in a community setting and into newborns unselected for risk. The results of a community-based clinical trial utilizing a pragmatic trial design will be immediately applicable to the population at large and will establish a new standard of care for all newborns.


Options:
A: Number of Participants With Peanut Allergy at 60 Months of Age - by Skin Prick Test Stratum (60 months); Number of Participants With Peanut Allergy at 60 Months of Age - Both Strata Combined (60 months)
B: Cumulative incidence of provider-diagnosed AD (up to 24 months)
C: Hospital Acquired Blood Stream Infection (28 days of life)
D: Proportion of eligible families screened who are willing and able to be randomised. (Before birth)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Single-arm Phase II Trial of Intra-operative Application of HEMOPATCH to the Pancreatic Stump to Prevent Post-operative Pancreatic Fistula Following Distal Pancreatectomy
Brief Summary: Despite improvements and advances in pancreas surgery, about 30-35% of patients who have pancreas surgery develop a type of complication called a pancreatic fistula. A pancreatic fistula occurs when fluid produced by the pancreas leaks into the abdomen after pancreas surgery. Patients who develop a pancreatic fistula can have poor short-term and long-term consequences.We are studying the effect of a medical device named HEMOPATCH on the development and seriousness of pancreatic fistulas. HEMOPATCH is a thin, flexible bovine protein-based pad that may improve tissue sealing where it is applied during surgery. Some small studies called case studies of between 2 and 7 patients, and two clinical trials have shown that HEMOPATCH is effective at stopping bleeding and reducing drain output after some types of surgery. However, there have been no completed clinical trials using HEMOPATCH to prevent or reduce pancreatic fistulas in patients having pancreas surgery, so we don't know if it works in this setting. Health Canada has approved the use of HEMOPATCH as a device to stop bleeding or seal other bodily fluids for procedures in which the control of bleeding or leakage of other body fluids or air by standard surgical techniques are either ineffective or impractical.


Options:
A: Pancreatic fistula development post distal pancreatectomy (30 days post surgery)
B: The rate of pancreatic fistula between groups (postoperative 3rd day)
C: Rate of postoperative complications of grade > II according to Dindo-Clavien classification (90 days); Rate of overall postoperative complications (90 days); Rate of postoperative mortality (90 days)
D: Number of Participants With a Clinically Significant Post-operative Pancreatic Fistula (POPF) (Within 90 days post-operatively)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Study With an Initial Treatment Period Followed by a Randomized-Withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Brief Summary: Phase 3 study to compare the efficacy of bimekizumab versus placebo in the treatment of subjects with moderate to severe chronic plaque psoriasis.


Options:
A: Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16 (At Week 16); Percentage of Participants With an Investigator's Global Assessment (IGA) Response at Week 16 (At Week 16)
B: Proportion of patients with at least 75% improvement in PASI from baseline (PASI75) at Week 16. (Baseline to week 16)
C: Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) by Drug Delivery Device (Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)); PK: Area Under the Concentration Time Curve From Time Zero to Last Measured Concentration Value (AUC 0-[Tlast]) by Drug Delivery Device (Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration))
D: Percentage of Participants Achieving 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI 100) (Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Study With an Initial Treatment Period Followed by a Randomized-Withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Brief Summary: Phase 3 study to compare the efficacy of bimekizumab versus placebo in the treatment of subjects with moderate to severe chronic plaque psoriasis.


Options:
A: Proportion of patients in remission defined by disease specific composite scores Study part A (30 weeks); Sustained disease control throughout the study period without disease worsening defined by disease specific composite scores Study part B (52 weeks)
B: Percentage of Participants With a PASI 75 Response at Week 12 (Baseline and week 12)
C: Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16 (At Week 16); Percentage of Participants With an Investigator's Global Assessment (IGA) Response at Week 16 (At Week 16)
D: Number of Patients Experiencing One or More Adverse Events Occurring From Week 0 Through Week 12 (from week 0 to week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Targeting Balance Confidence as a Strategy to Increase Integration and Improve Outcomes in Users of Lower-Limb Prostheses
Brief Summary: Low balance confidence occurs when an individual perceives they have limited ability to maintain their balance while performing a specific task of daily living. It is a prevalent problem in lower limb prosthesis users and is a strong predictor of prosthesis use and community participation. Balance confidence is not necessarily related to functional abilities. It is possible to improve functional ability as a result of rehabilitation, without concurrently improving balance confidence. Interventions to address low balance confidence may need to target both functional abilities as well as beliefs regarding these abilities. The purpose of this study is to test whether, for users of lower limb prostheses, an intervention combining physical therapy exercise to improve function with cognitive behavioral therapy to address fears and thoughts associated with low confidence can improve balance confidence and promote community participation.


Options:
A: Community integration (24 weeks)
B: Timed Up-and-Go Test (Baseline, 12-weeks, and 24 weeks)
C: Timed Up & Go Test (TUG) (6 weeks)
D: Pre-intervention:10 Meter Walk Test (10MWT) (Week 12-13); Pre-intervention: 6 Minute Walk Test (6MWT) (Week 12-13); Pre-intervention: Berg Balance Scale Test (Week 12-13); Post-intervention:10 Meter Walk Test (10MWT) (Week 24-25); Post-intervention: 6 Minute Walk Test (6MWT) (Week 24-25); Post-intervention: Berg Balance Scale Test (Week 24-25); Delayed post-intervention:10 Meter Walk Test (10MWT) (Week 40-41); Delayed post-intervention: 6 Minute Walk Test (6MWT) (Week 40-41); Delayed post-intervention: Berg Balance Scale Test (Week 40-41)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Efficacy of Addition of Hyaluronidase to Lidocaine and Bupivacaine in Scalp Nerves Block in Elective Craniotomy Operations, Comparative Study
Brief Summary: Safety and efficacy of addition of hyaluronidase to lidocaine and bupivacaine in scalp nerves block in elective craniotomy operations,Comparative study


Options:
A: Post-operative pain evaluation (up to 24 hours postoperatively)
B: Narcotic Requirement After Surgery (48 hours)
C: Quality of Recovery (24 hours)
D: Subjectively-rated pain intensity, using a 0-10 NRS (0=no pain, 10 = unbearable pain) (8 h)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: MesoTRAP: A Pilot Clinical Trial and Feasibility Study Comparing Video-assisted Thoracoscopic Partial Pleurectomy/Decortication With Indwelling Pleural Catheter in Patients With Trapped Lung Due to Malignant Pleural Mesothelioma Designed to Address Recruitment and Randomisation Uncertainties and Sample Size Requirements for a Phase III Trial.
Brief Summary: Malignant pleural mesothelioma is a cancer, caused by asbestos, which currently affects 2500 people in the UK each year. The main symptom is breathlessness caused by fluid building up in the space between the lung and the chest wall (pleural effusion). Treatment involves draining the fluid to allow the lung to re-expand (pleurodesis). However, sometimes tumour growth over the surface of the lung can prevent it from re-expanding. This 'trapped' lung results in fluid re-accumulation and repeated drainage which can lead to discomfort and multiple hospital visits.

One approach to dealing with 'trapped' lung in mesothelioma is to insert a thin tube (Indwelling Pleural Catheter - IPC) into the space around the lung. The tube can stay in place for a long time allowing patients to drain off fluid at home.

Another approach is a keyhole surgical operation (video-assisted thoracoscopic partial pleurectomy/decortication - VAT-PD) to remove as much tumour as possible from the lining of the lung to allow it to re-expand.

While both approaches are currently offered in clinical practice, it is not known which of the two is most effective at relieving breathlessness. The only way to find out is to conduct a research trial comparing the two. The Investigators plan to do this, but first of all need to carry out a small pilot study to collect information necessary to help plan the full study.


Options:
A: Feasibility of recruiting 30 patients within 12 months and randomising them to either EDIT Management or Standard Care (12 months)
B: Radiological lung expansion after talc pleurodesis and clinical outcome (6 months)
C: Survival at 1 year after treatment (1 year)
D: To measure the standard deviation of Visual Analogue Scale scores for breathlessness (Daily from randomisation to 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-Blind Study With an Active-Controlled Initial Treatment Period Followed by a Dose-Blind Maintenance Treatment Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Brief Summary: This is a study to compare the efficacy of bimekizumab versus adalimumab in the treatment of subjects with moderate to severe chronic plaque psoriasis (PSO).


Options:
A: Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 at Week 16 (At Week 16); Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 16 (At Week 16)
B: Aortic Vascular Inflammation as Measured by FDG-PET/CT (baseline, 12 weeks)
C: Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0) (Week 0 and Week 16)
D: Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16 (Week 16); Percentage of Participants With an Investigator's Global Assessment (IGA) Response (Clear or Almost Clear With at Least 2-Category Improvement Relative to Baseline) at Week 16 (Week 16)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-Blind Study With an Active-Controlled Initial Treatment Period Followed by a Dose-Blind Maintenance Treatment Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Brief Summary: This is a study to compare the efficacy of bimekizumab versus adalimumab in the treatment of subjects with moderate to severe chronic plaque psoriasis (PSO).


Options:
A: Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16 During the Placebo-Controlled Phase (Baseline and Week 16 of the placebo-controlled phase)
B: Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16 (Week 16); Percentage of Participants With an Investigator's Global Assessment (IGA) Response (Clear or Almost Clear With at Least 2-Category Improvement Relative to Baseline) at Week 16 (Week 16)
C: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A) (Week 16); Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Part A) (Week 16); Percentage of Participants Who Were Re-Randomized to Receive Either Adalimumab or Risankizumab in Part B Achieving PASI90 at Week 44 (Part B) (Week 44)
D: Change from baseline in the target (atherosclerotic plaque) to background (blood) ratio (TBR) from the ascending aorta at Week 16 for patients randomized to adalimumab as compared to patients randomized to placebo (Baseline, Week 16 and Week 52 or 68)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of a Mobile Phone Text Messages Intervention on the Secondary Prevention of Cardiovascular Events After Acute Coronary Syndrome
Brief Summary: The study is a two-arm, parallel, randomized clinical trial. The purpose of the study is to evaluate the effectiveness of automated mobile phone text message-based intervention for secondary prevention after acute coronary syndrome hospitalization. Text messages will include information about lifestyle modifications, medication adherence and cardiovascular risk factor control. The participants will be randomized into intervention and control groups in a 1:1 ratio. The intervention group will receive 4 pre-designed and semi-personalized text messages per week in addition to usual care for 6 months, while the control group will receive usual care.


Options:
A: Change in medication adherence over 12 months (12 months); Change in medication adherence over 12 months (12 months); Change in medication adherence at 12 months (12 months); Change in medication adherence at 12 months (12 months); Change in medication adherence at 12 months (12 months)
B: systolic blood pressure (change from baseline to 12-month of follow-up)
C: Medication Adherence (12 months after intervention); Mean Proportion of Days Covered Relative to Usual Care (12 months)
D: Escore of combined risk factor control (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of a Mobile Phone Text Messages Intervention on the Secondary Prevention of Cardiovascular Events After Acute Coronary Syndrome
Brief Summary: The study is a two-arm, parallel, randomized clinical trial. The purpose of the study is to evaluate the effectiveness of automated mobile phone text message-based intervention for secondary prevention after acute coronary syndrome hospitalization. Text messages will include information about lifestyle modifications, medication adherence and cardiovascular risk factor control. The participants will be randomized into intervention and control groups in a 1:1 ratio. The intervention group will receive 4 pre-designed and semi-personalized text messages per week in addition to usual care for 6 months, while the control group will receive usual care.


Options:
A: Escore of combined risk factor control (6 months)
B: Lifestyle (3 months); Quality of Life (QoL) (3 months); Behavioral flexibility (3 months)
C: Autonomic Function (Change from Baseline in Autonomic Function at 8 weeks of Cardiac Rehabilitation Program)
D: flow mediated dilation, serum concentrations of biomarkers, restenosis-rate/ late luminal loss, heart rate variability in SDNN (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Granulocyte Colony Stimulating Factor in Decompensated Cirrhosis: an Open Label Study
Brief Summary: Globally, cirrhosis is the fifth commonest cause of mortality. Its natural history is typified by an initial, largely asymptomatic, "compensated" phase followed by "decompensation" due to complications of raised portal pressures and hepatocellular dysfunction.

Currently the only definitive treatment option for cirrhosis is liver transplantation which is limited in its applicability due to donor shortage, exorbitant costs and lack of widespread availability. The need for long term immunosuppression and its attendant complications are a further drawback. The ability of stem cells to differentiate into multiple cellular lineages makes one speculate that they can be used for tissue repair and regeneration when tissue-resident stem cells become overwhelmed. Bone marrow derived stem cells have amazing plasticity. They can "home" to the liver in response to injury and help in liver regeneration by trans-differentiation, cell fusion and augmentation of tissue- resident stem cell mediated repair. Two methods are available for the mobilisation of stem cells from the bone marrow to the liver. One involves the administration of cytokines like granulocyte-colony stimulating factor (G-CSF) and the other is the isolation of stem cells from the marrow followed by their injection into the hepatic artery or portal vein after purification. The latter is probably more cumbersome and may be potentially risky due to the underlying coagulation abnormalities in cirrhotic patients .

G-CSF has been shown to mobilise bone marrow stem cells and even increase survival in patients of severe alcoholic steatohepatitis and ACLF. There is conflicting evidence on the role of G-CSF in decompensated cirrhosis with some studies showing improved survival while others have shown a lack of clinical or biochemical benefit. Many of these studies have used a single course of G-CSF. Verma et al, in a recent study published in 2018, elegantly demonstrated the beneficial effect of multiple courses of G-CSF in improving mortality and transplant free survival in decompensated cirrhotics.

The investigators too speculate that multiple cycles of G-CSF could result in better outcomes in decompensated cirrhosis by causing more prolonged and sustained stem cell homing to the liver. Thus, this study is being undertaken to further evaluate the safety and efficacy of multiple cycles of G-CSF in decompensated cirrhotics.


Options:
A: Primary end point- Survival at the end of 90 days (90 days)
B: Transplant-free survival up to 90 days (death or transplant count as events) (90 days)
C: Survival (One year)
D: transplant free survival at 1 year (3 Months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D Intervention in Children With Sickle Cell Disease: A Pilot Randomized Controlled Trial
Brief Summary: Sickle cell disease (SCD) is a genetic disease characterized by abnormal hemoglobin, the main constituent of red blood cells. People with SCD have nutritional deficiencies, and vitamin D deficiency is one of the most common. Symptoms of vitamin D deficiency are similar to those of SCD and include chronic pain and bone complications. Correcting vitamin D nutrition of children with SCD represents a treatment that will improve their health. A single oral high-dose of vitamin D3 will be given to SCD children during one of their follow-up visits at the SCD clinic of CHU Sainte-Justine, Montreal, Canada. This mode of administration was chosen to ensure a better adherence to the treatment. The investigators will determine whether this dose is safe and its administration feasible in clinic. The impact of this dose on blood vitamin D and calcium, urinary calcium, growth, inflammation, bone health, pain and quality of life will also be assessed. This study intends to propose a new intervention to improve the nutrition of children with this disease.


Options:
A: Number of Occurrences of Painful Sickle Cell Crises (From Week 0 through Week 48 (cumulative))
B: Mean change in total serum 25-hydroxyvitamin D levels (3 months)
C: Red Blood Cell Folate Concentration (12 weeks); Red Blood Cell Folate Concentration (36 weeks)
D: Incidence of infection (12 months)

Answer: B