TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-center, Open-label, Prospective, Randomized, Parallel Group Study Investigating a CNI-free Regimen With Enteric-Coated Mycophenolate Sodium (EC-MPS) and Everolimus in Comparison to Standard Therapy With Enteric-Coated Mycophenolate Sodium (EC-MPS) and Cyclosporine Microemulsion in de Novo Renal Transplant Patients
Brief Summary: The purpose of this study is to assess whether a calcineurin inhibitor (CNI)-free regimen with enteric-coated mycophenolate sodium (EC-MPS) and everolimus is as safe and well-tolerated as the standard regimen containing enteric-coated mycophenolate sodium (EC-MPS) and cyclosporine microemulsion, but results in better renal function.


Options:
A: GFR calculated from the serum creatinine with the Cockcroft-Gault formula at 12 months posttransplantation
B: Renal Function (Nankivell Formula) at Month 12 Post Transplantation. (at Month 12 post transplantation)
C: Equivalence of graft survival at month 12
D: Renal Function Assessed by Change in Estimated Glomerular Filtration Rate(eGFR) (Baseline and Month 6)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Liraglutide on Glycaemic Control in Subjects With Type 2 Diabetes.
Brief Summary: This trial is conducted in Europe. The trial is designed to show the effect of treatment with liraglutide or placebo on blood glucose control after 14 weeks in subjects with type 2 diabetes. Liraglutide or placebo is administered by injection once daily in the evening. The trial is a multi-national trial with treatment concealed to participating subjects, investigators and the sponsor. Treatment allocation is random with equal chance of being assigned to each group.


Options:
A: HbA1c (after 26 weeks of treatment)
B: HbA1c (after 14 weeks treatment)
C: Change in Glycosylated A1c (HbA1c) at Week 26 (week 0, week 26); Change in Glycosylated A1c (HbA1c) at Week 104 (week 0, week 104)
D: Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26 (Week 0, Week 26); Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (Week 0, Week 52); Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78 (Week 0, Week 78); Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78 (Week 52, Week 78)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Community-based Helicobacter Pylori Eradication With Two Sequential Antibiotic Regimens for the Residents and Migrants From a High-risk Area for Gastric Cancer
Brief Summary: Based on a universal eradication of H. pylori in an offshore island (Matsu) with a high prevalence of gastric cancer as well as premalignant gastric lesion, we first examined the infection rate of H. pylori. Secondly, we evaluated the efficacy of clarithromycin-based triple therapy with a levofloxacin-based rescue treatment. And thirdly, we tested the hypothesis that whether the cure of H. pylori can reverse the premalignant gastric lesion. Fourth, we determine the cost-effectiveness of this intervention. The gene-environment interaction will be addressed regarding gastric cancer carcinogenesis. Finally, the incident rate of gastric cancer would be followed in this cohort.


Options:
A: Successful helicobacter eradication, change in premalignant gastric lesion, and change in gastric cancer incidence rate (12 years)
B: Effect of eradication of Helicobacter pylori on incidence of metachronous gastric carcinoma after endoscopic resection of gastric tumor. (we set the time frame as at least three years.)
C: Improvement (histological) of glandular atrophy (3 years after enrollment); Incidence of metachronous gastric cancer (3 years after last patient enrollment)
D: Gastric cancer mortality (15 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Cognitive-Behavioral Therapy on Sleep Disturbance in Peritoneal Dialysis Patients
Brief Summary: Sleep disturbance is prevalent in chronic dialysis patients and there is a negative correlation between the quality of life and overall survival and sleep disturbance in them. Cognitive-behavioral therapy is an effective behavioral therapy for insomnia clinically. In previous studies, cognitive-behavioral therapy can redress anxiety in chronic hemodialysis patients. This study tries to elucidate its therapeutic effect on the sleep disturbance in chronic peritoneal dialysis patients.


Options:
A: Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen (From Baseline (Day -28 to Day 1) to EOIT (Week 19))
B: composite of 12 month mortality and the change over 12 months in left ventricular mass by cine-MRI, (12 months); a composite of 12 month mortality and the change over 12 months in the SF-36 RAND physical health composite (12 months)
C: Check Pittsburgh Sleep Quality Index and restless leg syndrome index: in 1st and 3rd months
D: Changes in Fatigue Symptom Inventory (FSI) (Baseline and week 4); Changes in Fatigue Symptom Inventory (FSI) (Baseline and week 8); Changes in Fatigue Symptom Inventory (FSI) (Baseline and week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial of Hypofractionated Radiotherapy Post-Lumpectomy in Women With Node Negative Breast Cancer
Brief Summary: To determine if hypofractionated radiotherapy to the whole breast (4,250 cGy/16 fractions over 22 days) is equally effective to standard fractionated radiotherapy (5,000 cGy/25 fractions over 35 days) in women with node negative breast cancer who have undergone lumpectomy.

The primary outcome is local breast recurrence and secondary outcomes include morbidity and cost effectiveness.


Options:
A: Local breast recurrence (Indefinitely)
B: Number of Participants With Scores of Either <2.5 or >=2.5 on the Breast Cancer Treatment Outcome Scale (BCTOS) Cosmesis (3 years after completing radiation therapy)
C: Change from baseline in pulmonary function and heart function tests (From end of treatment up to 3 years after treatment)
D: Disease Free Survival (DFS) (Time from randomization through 5 years); Cardiotoxicity (time from randomization through 4 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 14-Week, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study To Evaluate The Safety And Efficacy Of Pregabalin (150mg-600mg/Day) Using A Flexible Optimal Dose Schedule In Patients With Painful Diabetic Peripheral Neuropathy (DPN).
Brief Summary: A study of pregabalin efficacy and safety in a racially and culturally diverse group of subjects with painful diabetic peripheral neuropathy (DPN).


Options:
A: Mean pain score
B: Nerve conduction measurements; Pain scores from patient diaries
C: Patient's Global Impression of Change (PGIC)
D: Onset meaningful pain reduction

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 14-Week, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study To Evaluate The Safety And Efficacy Of Pregabalin (150mg-600mg/Day) Using A Flexible Optimal Dose Schedule In Patients With Painful Diabetic Peripheral Neuropathy (DPN).
Brief Summary: A study of pregabalin efficacy and safety in a racially and culturally diverse group of subjects with painful diabetic peripheral neuropathy (DPN).


Options:
A: Change From Baseline to Study Endpoint in Mean Weekly Pain Scores (From baseline to Week 13 or up to study discontinuation (Study Endpoint)); Change From Baseline to Study Endpoint in Mean Weekly Pain Scores by Groups of Subjects With Expected Similar Plasma Concentrations (From baseline to Week 13 or up to study discontinuation (Study Endpoint)); Number of Responders (From baseline to Week 13 or up to study discontinuation (Study Endpoint)); Change From Baseline at Week 1 in Mean Weekly Pain Scores (From baseline to Week 1); Change From Baseline at Week 2 in Mean Weekly Pain Scores (From baseline to Week 2); Change From Baseline at Week 3 in Mean Weekly Pain Scores (From baseline to Week 3); Change From Baseline at Week 4 in Mean Weekly Pain Scores (From baseline to Week 4); Change From Baseline at Week 5 in Mean Weekly Pain Scores (From baseline to Week 5); Change From Baseline at Week 6 in Mean Weekly Pain Scores (From baseline to Week 6); Change From Baseline at Week 7 in Mean Weekly Pain Scores (From baseline to Week 7); Change From Baseline at Week 8 in Mean Weekly Pain Scores (From baseline to Week 8); Change From Baseline at Week 9 in Mean Weekly Pain Scores (From baseline to Week 9); Change From Baseline at Week 10 in Mean Weekly Pain Scores (From baseline to Week 10); Change From Baseline at Week 11 in Mean Weekly Pain Scores (From baseline to Week 11); Change From Baseline at Week 12 in Mean Weekly Pain Scores (From baseline to Week 12); Change From Baseline at Week 13 in Mean Weekly Pain Scores (From baseline to Week 13)
B: A mean of 24-hour average pain score measured by an 11-point Numeric Rating Scale (NRS) based on subject's daily diary (Weekly started at Baseline, Week 1, Week 2, Week 4, and Week 6 (End of Study))
C: Mean pain score
D: Onset meaningful pain reduction

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Fixed-Dose, 6-Week Trial of the Efficacy and Safety of Asenapine Compared With Placebo Using Haloperidol Positive Control in Subjects With an Acute Exacerbation of Schizophrenia
Brief Summary: Schizophrenia is a brain disease. The primary features of schizophrenia are characterized by Positive symptoms (symptoms that should not be there, inability to think clearly, to distinguish reality from fantasy i.e., hearing voices) and Negative symptoms (a reduction or absence of normal behaviors or emotions, i.e., unable to manage emotions, make decisions and relate to others). Other symptoms include reduced ability to recall and learn new information, difficulty with problem solving, or maintaining productive employment. The symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily dopamine and serotonin, which enables brain cells to communicate with each other.

Asenapine is an investigational drug that may help to correct the inbalance in dopamine and serotonin. This is a 6-week trial to test the efficacy and safety of asenapine, compared with placebo, using an active comparator agent (haloperidol) in the treatment of patients with an acute exacerbation of schizophrenia. Patients who complete the 6-week trial will have the option of continuing in an additional one year extension trial.


Options:
A: Change From Baseline to Week 6 in the PANSS Total Score (Baseline to Week 6)
B: A change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score in overall schizophrenia population (baseline, up to 7 weeks of treatment); A change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score in a genetic subgroup of schizophrenia patients (baseline, up to 7 weeks of treatment)
C: Improvement in schizophrenia (change in total PANSS score) from baseline to endpoint (LOCF/MMRM) (Primary outcome measured weekly for 6 weeks)
D: Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score (Baseline, Week 6)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Fixed-Dose, 6-Week Trial of the Efficacy and Safety of Asenapine Compared With Placebo Using Olanzapine Positive Control in Subjects With an Acute Exacerbation of Schizophrenia
Brief Summary: Schizophrenia is a brain disease. The primary features of schizophrenia are characterized by Positive symptoms (symptoms that should not be there, inability to think clearly, to distinguish reality from fantasy i.e., hearing voices) and Negative symptoms (a reduction or absence of normal behaviors or emotions, i.e., unable to manage emotions, make decisions and relate to others). Other symptoms include reduced ability to recall and learn new information, difficulty with problem solving, or maintaining productive employment. The symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily dopamine and serotonin, which enables brain cells to communicate with each other.

Asenapine is an investigational drug that may help to correct the imbalance in dopamine and serotonin. This is a 6 week study to test the efficacy and safety of asenapine and a comparator agent (olanzapine) in the treatment of patients with schizophrenia. Patients that complete this trial will have the option of continuing in an additional one year extension trial.


Options:
A: Improvement in schizophrenia (change in total PANSS score) from baseline to endpoint (LOCF/MMRM) (Primary outcome measured weekly for 6 weeks)
B: PANSS-total score
C: Change in total PANSS score at endpoint (6-week double-blind or last assessment after baseline) from baseline (Screen, baseline, Days 4,7,14,21,28,35,42)
D: Positive and Negative Syndrome Scale (PANSS) total score (Change from baseline to Day 28)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Effectiveness of Antibiotic Prophylaxis in Children With a History of Upper Urinary Tract Infections:a Multicentre Randomised Study
Brief Summary: Our hypothesis is that long-term antimicrobial prophylaxis does not reduce the recurrence of infection and the risk of appearance of kidney scars in children with a documented previous upper UTI.


Options:
A: 1. Duration of fever (>38°),; 2. Sterilization of the urine,; 3. Reduction of the blood inflammatory indices,; 4. Incidence of renal scarring documented at 12 month.
B: The primary end-point is UTI Recurrence Rate during the 12-month observation period and the Development of renal damage (parenchymal scar) after 12 months.
C: Recurrence of pyelonephritis (up to 4 years after enrollment)
D: Recurrent Febrile or Symptomatic Urinary Tract Infection During 2-year Follow-up (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries (Thunder - Trial)
Brief Summary: The Thunder Trail is a randomized , double-blinded, placebo controlled German multi-centre study on the efficacy of local paclitaxel for prevention of restenosis in the superficial and popliteal artery.


Options:
A: Late lumen loss of vessel segment following dilatation after 6 months
B: Target Lesion Percent Stenosis (at 1 Year)
C: angiographic late lumen loss (6 months)
D: Event-free Survival Rate (12 months); Primary Patency (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study on Gait & Motor Function in MS Using BWS Treadmill Training
Brief Summary: The primary purpose of this study is to collect preliminary and pilot data to begin to determine whether the use of body weight support treadmill therapy (BWSTT) with and without driven-gait-orthotics (DGO), results in improved motor recovery and ambulation MS patients with gait impairment


Options:
A: Feasibility of task-oriented circuit class therapy (12 months)
B: Self-reported fatigue (10 weeks); Upright postural control (10 weeks); Walking capacity (10 weeks)
C: Exercise compliance (Exercise compliance is registered immediatly after all planned exercise sessions during the 4 week intervention); Drop out rate (Number of participants who drop out is registered at the post measurement just after the intervention.)
D: Mean changes and variances in ambulation, motor, fatigue and quality of life (Baseline, cross-over, study endpoint)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial
Brief Summary: This research study will compare the treatment effects of three different asthma medications in asthma subjects whose asthma is well controlled when they take fluticasone, an inhaled corticosteroid. The treatments are fluticasone, montelukast (an anti?leukotriene drug), and a combination therapy of fluticasone and salmeterol (a long-acting beta-agonist). Fluticasone, montelukast, and the combination therapy of fluticasone and salmeterol (Advair Diskus®) are all approved for the treatment of asthma. We are looking at whether the three treatments are equally effective for reducing the number and the severity of asthma attacks in subjects with mild to moderately severe asthma.


Options:
A: Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period (Day 1 to Week 26 of the Treatment Period)
B: Total Number of Asthma Exacerbations Reported During the Treatment Period (From Baseline (Week 1) until the end of treatment (up to Week 16))
C: Treatment Failure (16 weeks)
D: Peak FEV1 Within 3 Hours Post-dose Response (24 weeks); Trough FEV1 Response (24 weeks); The Responder Rate as Assessed by the ACQ From the Two Twin Trials 205.418 (NCT01172808) and the Present 205.419 (NCT01172821) (24 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial
Brief Summary: This research study will compare the treatment effects of three different asthma medications in asthma subjects whose asthma is well controlled when they take fluticasone, an inhaled corticosteroid. The treatments are fluticasone, montelukast (an anti?leukotriene drug), and a combination therapy of fluticasone and salmeterol (a long-acting beta-agonist). Fluticasone, montelukast, and the combination therapy of fluticasone and salmeterol (Advair Diskus®) are all approved for the treatment of asthma. We are looking at whether the three treatments are equally effective for reducing the number and the severity of asthma attacks in subjects with mild to moderately severe asthma.


Options:
A: Oral montelukast is associated with reduced school absences in comparison to inhaled salmeterol over a period of 1 year in Arg/Arg-16 asthmatic children (Every 3 months)
B: Percentage of Symptom-free Days During the Last 10 Weeks of the Treatment Period (Last 10 weeks of the treatment period (Weeks 16-26))
C: Treatment Failure (16 weeks)
D: Change in Forced Expiratory Volume in 1 s(FEV-1) from Baseline (Week 0) to Week 12. (Week 0 and 12 visits); Discontinuation due to lack of efficacy. (Whole duration of study)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial
Brief Summary: This research study will compare the treatment effects of three different asthma medications in asthma subjects whose asthma is well controlled when they take fluticasone, an inhaled corticosteroid. The treatments are fluticasone, montelukast (an anti?leukotriene drug), and a combination therapy of fluticasone and salmeterol (a long-acting beta-agonist). Fluticasone, montelukast, and the combination therapy of fluticasone and salmeterol (Advair Diskus®) are all approved for the treatment of asthma. We are looking at whether the three treatments are equally effective for reducing the number and the severity of asthma attacks in subjects with mild to moderately severe asthma.


Options:
A: Oral montelukast is associated with reduced school absences in comparison to inhaled salmeterol over a period of 1 year in Arg/Arg-16 asthmatic children (Every 3 months)
B: To evaluate distal airway function using high-resolution CT and lung function test (6 months)
C: Rate of Asthma Exacerbations Over the 48 Week Treatment Period (48 weeks)
D: Treatment Failure (16 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial
Brief Summary: This research study will compare the treatment effects of three different asthma medications in asthma subjects whose asthma is well controlled when they take fluticasone, an inhaled corticosteroid. The treatments are fluticasone, montelukast (an anti?leukotriene drug), and a combination therapy of fluticasone and salmeterol (a long-acting beta-agonist). Fluticasone, montelukast, and the combination therapy of fluticasone and salmeterol (Advair Diskus®) are all approved for the treatment of asthma. We are looking at whether the three treatments are equally effective for reducing the number and the severity of asthma attacks in subjects with mild to moderately severe asthma.


Options:
A: Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Participants (8 Week treatment period initiated at the beginning of a school year)
B: Treatment Failure (16 weeks)
C: Change (%) From Baseline in FcεRI (High-affinity IgE Receptor) Expression on Blood Basophils and Dendritic Cells After 16 Weeks of Treatment With Omalizumab as Compared With Placebo (Baseline and Week 16); Change (%) From Baseline in Mean Fluorescence Intensity of FcεRI After 16 Weeks of Treatment With Omalizumab as Compared With Placebo (Baseline and Week 16)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Prophylactic Micronutrient Supplementation of Morbidity and Growth in HIV-infected and HIV-uninfected Children in South Africa
Brief Summary: The purpose of the study is to see if giving vitamin and mineral supplements helps to protect infants and children from diarrhea, which vitamins and minerals help to improve a child's weight and growth, and if the same results occur in infants and children with HIV. HIV is the virus that causes AIDS. Study participants will include 516 infants aged 4-6 months. Participants will include: (1) HIV-infected children, (2) HIV-uninfected children with HIV-infected mothers, and (3) HIV-uninfected children with HIV-uninfected mothers. Subjects will have an equal chance of receiving one of three different vitamin and/or mineral supplements during the study. Study procedures will include up to 7 blood samples and stool samples every 3 months and body composition every 6 months. Participants will be involved in the study for up to 18 months.


Options:
A: childhood mortality rate at age 1-6
B: N/A
C: Mortality; Morbidity; All outcomes are investigated for interactions between vitamin A, sex, and last vaccine received
D: Exclusive Breastfeeding Rates in Burkina Faso (at 3 months of age); Infant Morbidity, 2 Week Diarrhoea Prevalence (at 3 months of age); Exclusive Breastfeeding Rates in Uganda (at 3 months of age); Exclusive Breastfeeding Rates in South Africa (at 3 months of age)

Answer: B