TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Purified n-3 Fatty Acids on Serum Fibrosis Markers and Cardiovascular Risk Markers in a Randomized Placebo Controlled Trial in Patients With Non Alcoholic Fatty Liver Disease
Brief Summary: Non alcoholic fatty liver disease (NAFLD) imposes a high and increasing burden on the NHS, yet there is presently no licensed treatment or validated approach to management. NAFLD predisposes to increased risk of type 2 diabetes, increased risk of cardiovascular disease and may progress to chronic irreversible liver disease.

In NAFLD patients, the investigators will test the hypothesis that treatment with long chain n-3 fatty acid supplementation for 18 months favourably influences bio-markers for NAFLD and risk factors for cardiovascular disease and type 2 diabetes.


Options:
A: cardiovascular deaths and hospitalization for cardiovascular causes (5 years)
B: Percentage of Liver Fat (Baseline and 18 months); Liver Fibrosis Score (Baseline and 18 months); NAFLD Fibrosis Score (Baseline and 18 months)
C: Cumulative incidence of Major depressive Disorder (12 months)
D: Occurrence of appropriate ICD intervention (shock or antitachycardia pacing) for spontaneous ventricular tachyarrhythmias, or all-cause mortality

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Parent-Implemented Intervention for Toddlers With Autism Spectrum (The ESI Study)
Brief Summary: This study will compare the effectiveness of two parent-based programs for helping young children at risk of autism.


Options:
A: Child measures of autism symptoms, social communication, developmental level, and adaptive behavior (Measured before treatment, at crossover, and after treatment; some of these measures also will be taken every other month)
B: Cognitive Assessment - Mullen Scales of Early Learning (MSEL) (Before treatment begins and at the 6 month follow up); Language Assessment - Reynell Developmental Language Scales (Before treatment begins and at 6 month follow up)
C: Receptive language skills (Pre-tx, Post-tx, and 6 month follow up); Expressive language skills (Pre-tx, Post-tx, and 6 month follow up)
D: Number of words used spontaneously during language sample (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The AZIthromycin in Severe ASThma (AZISAST) Study: a Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Efficacy, Safety and Cost-effectiveness of Azithromycin as add-on Therapy in Adult Subjects With Severe Persistent Asthma, Who Remain Inadequately Controlled Despite GINA (2006) Step 4 or 5 Therapy
Brief Summary: The purpose of this study is to evaluate the efficacy, safety and cost-effectiveness of azithromycin as add-on therapy in adult subjects with severe persistent asthma, who remain inadequately controlled despite GINA (2006) step 4 or 5 therapy.


Options:
A: Number of exacerbations after 48 weeks of intermittent pulse treatment (After 48 weeks of treatment)
B: Overall Survival (Up to 9 years); Progression-free Survival (From the date of enrollment to first progression or death or last contact, if alive and progression free.)
C: Proportion of Participants With Severe Asthma Exacerbations (from baseline to week 26)
D: Reduction in number of exacerbations (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The AZIthromycin in Severe ASThma (AZISAST) Study: a Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Efficacy, Safety and Cost-effectiveness of Azithromycin as add-on Therapy in Adult Subjects With Severe Persistent Asthma, Who Remain Inadequately Controlled Despite GINA (2006) Step 4 or 5 Therapy
Brief Summary: The purpose of this study is to evaluate the efficacy, safety and cost-effectiveness of azithromycin as add-on therapy in adult subjects with severe persistent asthma, who remain inadequately controlled despite GINA (2006) step 4 or 5 therapy.


Options:
A: Diary card summary symptom score (10 days after randomisation)
B: Progression to Clinically Significant Lower Respiratory Tract Symptoms (14 days after initiation of APRIL therapy); OCELOT: Pediatric Respiratory Assessment Measure (36-72 hours after initiation of OCELOT therapy)
C: Percentage Reduction From Baseline in Oral Corticosteroids (OCS) Dose at Week 24 While Maintaining Asthma Control (Baseline, Week 24); Supplementary Presentation of Primary Outcome Measure Data: Median Percentage Reduction From Baseline in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control (Baseline, Week 24)
D: Proportion of Participants With Severe Asthma Exacerbations (from baseline to week 26)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The AZIthromycin in Severe ASThma (AZISAST) Study: a Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Efficacy, Safety and Cost-effectiveness of Azithromycin as add-on Therapy in Adult Subjects With Severe Persistent Asthma, Who Remain Inadequately Controlled Despite GINA (2006) Step 4 or 5 Therapy
Brief Summary: The purpose of this study is to evaluate the efficacy, safety and cost-effectiveness of azithromycin as add-on therapy in adult subjects with severe persistent asthma, who remain inadequately controlled despite GINA (2006) step 4 or 5 therapy.


Options:
A: Proportion of Participants With Severe Asthma Exacerbations (from baseline to week 26)
B: Product Evaluation (Once per module (One Evaluation per week for seven weeks))
C: Change from Baseline in adherence rate to entire treatment period (From baseline to end of participation (up to 3 months))
D: Proportion of Days Covered (PDC) (6 months post start of intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The AZIthromycin in Severe ASThma (AZISAST) Study: a Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Efficacy, Safety and Cost-effectiveness of Azithromycin as add-on Therapy in Adult Subjects With Severe Persistent Asthma, Who Remain Inadequately Controlled Despite GINA (2006) Step 4 or 5 Therapy
Brief Summary: The purpose of this study is to evaluate the efficacy, safety and cost-effectiveness of azithromycin as add-on therapy in adult subjects with severe persistent asthma, who remain inadequately controlled despite GINA (2006) step 4 or 5 therapy.


Options:
A: Forced Expiratory Volume in one second z score (FEV1) (12 months)
B: Proportion of Participants With Severe Asthma Exacerbations (from baseline to week 26)
C: Time to clinical failure (Will be assessed between day 1 (from 1 hour after first drug intake) till day 90 (24 hours after last study drug intake))
D: All-cause Mortality Rate in Children Aged 1-60 Months (24 Months); All-cause Mortality Rate in Children Aged 1-60 Months (36 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Music to Reduce Pain and Anxiety in the Pediatric Emergency Department: a Randomized Controlled Trial of Children 3-6 Years Undergoing Intravenous Placement
Brief Summary: Many medical procedures aimed at helping children can cause them pain and distress. If children experience certain levels of pain or distress, it can have long lasting negative effects. The emergency department can be a particularly stressful place for children and their parents. There are also many procedures that children may have in the emergency department that can cause pain and distress. These include procedures such as needle pokes, stitches, or setting a broken bone. Two common methods of managing a child's pain in the emergency department are drugs and distraction. Drugs are not always practical and may come with unwanted side effects. Distraction is often used formally or informally and by parents or the health professionals. One form of distraction involves listening to music. This can lower the child's pain and distress by moving their attention from the painful stimulus, for example a needle poke, to a more pleasant sensation such as familiar children's songs. This study will test whether music is useful to help lower pain and distress for young children (ages 3 to 6 years) who are visiting an emergency department and need an intravenous line. Music is safe and pleasant for children. The results from this study could be important for many children receiving medical care.


Options:
A: Faces Pain Scale-Revised (5 mins before and immediate after vaccination)
B: Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children Measure by m-YPAS. (24 hours before surgery)
C: Patient's level of anxiety (at day 1)
D: Observation Scale of Behavioral Distress-Revised (OSBD-R)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: To Verify the Efficacy of Z-338 in Subjects With Functional Dyspepsia, Focusing on the Assessment of Subjective Symptoms
Brief Summary: The purpose of this study is to verify the superior efficacy of Z-338 to placebo in subjects with Functional Dyspepsia, focusing on the assessment of subjective symptoms.


Options:
A: General impression at last visit in treatment period (4 week); Elimination rate of post-prandial fullness, upper abdominal bloating and early satiety at last visit in treatment period (4 week)
B: The primary outcome is whether the patient is a responder or not after 8 weeks treatment.; The primary efficacy outcome is based on symptom score recorded daily during the study in a patient diary.; The patient will judge their symptoms of pain or burning centered in the upper abdomen on a four-graded scale (none, mild, moderate or severe).
C: Response rate of overall symptom improvement after 4-weeks treatment (4 weeks)
D: After 8 weeks of treatment:; Change of the severity of functional dyspepsia symptoms assessed by the Leeds Dyspepsia Questionnaire); Patient's global assessment of efficacy (proportion of patients symptom-free or markedly improved); Improvement of pain and/or fullness by at least one grade on a 5-grade scale.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Single-blind, Placebo-controlled, 4-Week Treatment Study of the Safety and Biologic Activity of Escalating Multiple Oral Doses of FG-4592 in Subjects With Chronic Kidney Disease Not Requiring Dialysis
Brief Summary: The primary objective of the study is to evaluate the safety, tolerability, and pharmacodynamic effects of different oral doses of roxadustat administered 2 times a week (BIW) or 3 times a week (TIW) for up to 4 weeks to participants with chronic kidney disease (CKD) not requiring dialysis.


Options:
A: Number of Participants With Week 7 Hb ≥ Baseline Hb - 0.5 g/dL, Among Normoresponder Participants Treated for 6 Weeks Only (Week 7); Number of Participants With Week 7 Hb ≥ Baseline Hb - 0.5 g/dL, Among Hyporesponsive Participants Treated for at Least 6 Weeks (Week 7); Number of Participants With a Mean Hb Above 11 g/dL When the Mean Hb Values at Weeks 17, 18, 19, and 20 Were Averaged, Among Participants Treated for 19 Weeks (Weeks 17, 18, 19, and 20)
B: Percentage of Participants With a Hemoglobin (Hb) Response to Treatment at Two Consecutive Visits During the First 24 Weeks of Treatment Without Rescue Therapy Prior to Hb Response (Baseline to week 24); Hb Change From Baseline (BL) to the Average Hb in Weeks 28-52 Regardless of Rescue Therapy (Baseline and weeks 28 to 52)
C: Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36) (Baseline; Weeks 24 to 36); Median Time to First Major Adverse Cardiovascular Event (MACE) (Up to Week 208)
D: Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) (Baseline up to Week 16 (End of Study (EoS])); Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Day 26-29 (End of Treatment) (Baseline, End of Treatment (EoT) (Day 26 for TIW Dosing or Day 29 for BIW Dosing)); Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Week 8 (2 Weeks of Follow Up) (Baseline, Week 8 (2 Weeks of Follow Up))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Fixation Using Alternative Implants for the Treatment of Hip Fractures: A Multi-Centre Randomized Trial Comparing Sliding Hip Screws and Cancellous Screws on Revision Surgery Rates and Quality of Life in the Treatment of Femoral Neck Fractures
Brief Summary: Each year, hip fracture, an injury that can impair independence and quality of life, occurs in about 280,000 Americans and 36,000 Canadians. The annual healthcare costs associated with this injury are expected to soon reach $9.8 billion in the United States and $650 million in Canada. It is important to have in place optimal practice guidelines for the surgical handling of this injury. One type of hip fracture, called a femoral neck fracture, is often treated with a surgical procedure called internal fixation. When performing internal fixation, most orthopaedic surgeons favor using multiple small diameter screws over using a single large diameter screw with a sliding plate. However, use of the sliding hip screw might in fact result in fewer complications after surgery and reduce the need for a second surgery, called a revision surgery. This study will compare the two different surgical procedures to determine which one results in better outcomes after surgery.


Options:
A: Number of Participants With Revision Surgery (Measured 2 years after original surgery)
B: Dislocation (1 year after index surgery)
C: Revision Surgery (Measured 2 years after original surgery)
D: Composite variable comprising reoperation rate and mortality (1 to 2-year post-surgery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Autologous Bone Marrow Stem Cells in Middle Cerebral Artery Acute Stroke Treatment
Brief Summary: The aim of the study is to determine the safety and efficacy on an autologous CD34+ subset bone marrow stem cell infusion into the middle cerebral artery in patients who have suffered acute middle cerebral artery stroke.


Options:
A: Functional Independence Measure (6 months)
B: Barthel index score (six month post randomization)
C: Categorical shift in modified Rankin scale (mRS) (90 days after the cell treatment)
D: Absence of new neurological deficits and adverse effects during the timeframe. (Duration of study)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Oral Viscous Budesonide Suspension (MB-7) in Subjects With Eosinophilic Esophagitis: A Randomized, Placebo-Controlled, Dose-Ranging Study in Children and Adolescents
Brief Summary: This is a randomized, placebo-controlled, parallel-arm, dose-ranging study in subjects with eosinophilic esophagitis, 2-18 years of age. Eligible subjects will be randomized into one of four treatment groups. The Treatment Period will be 12 weeks during which subjects will visit the clinic at study weeks 0 (Baseline Visit), 2, 4, 8 and 12 (Final Treatment Evaluation) for clinical symptom assessment and safety evaluation (including adverse events and vital signs). All study treatments (active drug and placebo) will be administered orally twice daily during the Treatment Period, once in the morning after breakfast and once in the evening at bedtime.


Options:
A: Number of Participants With Improvement of Espohageal Eosinophilia (3 Months)
B: Rate of histological remission (2 weeks (LOCF)); Change in the mean numbers of eos (2 weeks (LOCF))
C: Post-Treatment Maximum Eosinophil Count (Aim 1) (8 weeks); Post-treatment Dysphagia Score (Aim 1) (8 weeks)
D: Percent of Participants Who Responded to Therapy (12 weeks after the start of treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Long Term Effects of Lutein/Zeaxanthin and Omega-3- Supplementation on Optical Density of AMD Patients (LUTEGA)
Brief Summary: The primary objective of LUTEGA is it to determine the long term effect (about 1 year) of the supplementation with a fixed combination of lutein/zeaxanthin and omega-3- fatty acids on the optical density (OD) of macular pigment in patients with non- exudative age related maculopathy.

Furthermore, it is to be examined whether changes of the optical density are different dosages dependent. Possible changes of lipofuscin content and effect on drusen in AMD patients are studied. The measurement of optical density of macular pigment uses the 1- wavelength reflection method recording reflection images at 460 nm by a fundus camera. The patients are investigated at baseline and are followed up over one year in four more visits. In addition to the OD- measurement each examination includes standardized visual acuity test (ETDRS), amsler- grid, slit lamp biomicroscopy, fundus photography (color and autofluorescence) and a blood sample.


Options:
A: COPD exacerbations in the past year over the course of the study (at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year); Airflow obstruction/change in pulmonary function (pre-randomization and after 2 years follow-up); Pneumonia in the past year over the course of the study (at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year)
B: Cumulative incidence of Major depressive Disorder (12 months)
C: MRI disease activity measured by the number of new T1-enhancing lesions during the six months of treatment.; MRI disease activity measured by the number of new T1-hypo-intensive lesions (black holes) after 24 months of treatment.
D: Optical density of macular pigment (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Long Term Effects of Lutein/Zeaxanthin and Omega-3- Supplementation on Optical Density of AMD Patients (LUTEGA)
Brief Summary: The primary objective of LUTEGA is it to determine the long term effect (about 1 year) of the supplementation with a fixed combination of lutein/zeaxanthin and omega-3- fatty acids on the optical density (OD) of macular pigment in patients with non- exudative age related maculopathy.

Furthermore, it is to be examined whether changes of the optical density are different dosages dependent. Possible changes of lipofuscin content and effect on drusen in AMD patients are studied. The measurement of optical density of macular pigment uses the 1- wavelength reflection method recording reflection images at 460 nm by a fundus camera. The patients are investigated at baseline and are followed up over one year in four more visits. In addition to the OD- measurement each examination includes standardized visual acuity test (ETDRS), amsler- grid, slit lamp biomicroscopy, fundus photography (color and autofluorescence) and a blood sample.


Options:
A: Development of Advanced AMD in People at Moderate to High Risk for Progression. (5 years of follow-up)
B: Occurrence of appropriate ICD intervention (shock or antitachycardia pacing) for spontaneous ventricular tachyarrhythmias, or all-cause mortality
C: Histological Response Defined by Change From Baseline in Standardized Scoring of Liver Biopsies (12 months); Alanine Transaminase (ALT) Levels (3 month endpoint); Alanine Transaminase (ALT) Levels (6 months)
D: Optical density of macular pigment (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Long Term Effects of Lutein/Zeaxanthin and Omega-3- Supplementation on Optical Density of AMD Patients (LUTEGA)
Brief Summary: The primary objective of LUTEGA is it to determine the long term effect (about 1 year) of the supplementation with a fixed combination of lutein/zeaxanthin and omega-3- fatty acids on the optical density (OD) of macular pigment in patients with non- exudative age related maculopathy.

Furthermore, it is to be examined whether changes of the optical density are different dosages dependent. Possible changes of lipofuscin content and effect on drusen in AMD patients are studied. The measurement of optical density of macular pigment uses the 1- wavelength reflection method recording reflection images at 460 nm by a fundus camera. The patients are investigated at baseline and are followed up over one year in four more visits. In addition to the OD- measurement each examination includes standardized visual acuity test (ETDRS), amsler- grid, slit lamp biomicroscopy, fundus photography (color and autofluorescence) and a blood sample.


Options:
A: Optical density of macular pigment (12 months)
B: cardiovascular deaths and hospitalization for cardiovascular causes (5 years)
C: MRI disease activity measured by the number of new T1-enhancing lesions during the six months of treatment.; MRI disease activity measured by the number of new T1-hypo-intensive lesions (black holes) after 24 months of treatment.
D: Survival free of atrial fibrillation (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Validation of a Predictive Model to Estimate the Risk of Conversion to Clinically Significant Macular Edema and/or Vision Loss in Mild Nonproliferative Diabetic Retinopathy in Diabetes Type 2
Brief Summary: This project aims to validate a predictive model of diabetic retinopathy progression to clinically significant macular edema (CSME) needing photocoagulation and/or vision loss. The Coimbra Predictive Model (CPM), based on retinal thickness, microaneurysms number, HbA1C and LDL levels, established on a set of 52 diabetic patients, will be tested on a population of 400 patients/eyes to be enrolled into the study. These patients will perform 2 visits at 6-month interval (V0 and V6) to classify each patient into one of the 3 previously established phenotypes. Two years after (V24) patients will be reexamined. The occurrence of end-points, achieved by the patients, are expected to validate our predictive model.


Options:
A: Change in the central subfield of the ETDRS grid measured by OCT. (1 Year)
B: Core Study: Difference Between the Baseline Level of Visual Acuity (Letters) of the Study Eye and the Mean Visual Acuity Averaged Over All Monthly Post-baseline Assessments From Month 1 to Month 12 (Baseline through the end of study (Month 12)); Extension Study: Percentage of Participants With Ocular Adverse Events (AEs) in the Study Eye in the 24 Month Extension Study (Extension baseline (Month 12 -end of core study) to Month 36 (end of extension study) [24 Months]); Extension Study: Percentage of Participants With Non-Ocular Adverse Events (AEs) in the 24 Month Extension Study (Extension baseline (Month 12 -end of core study) to Month 36 (end of extension study) [24 Months])
C: Difference Between the Baseline Level of Visual Acuity (Letters) of the Study Eye and the Mean Visual Acuity Averaged Over All Monthly Post-baseline Assessments From Month 1 to Month 12 (Baseline through the end of study (Month 12)); Mean Change From Baseline in Visual Acuity (Letters) of the Study Eye at Month 12 (Baseline through the end of study (Month 12))
D: CSME needing Photocoagulation (24 months)

Answer: D