TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: To Assess Safety, Reactogenicity & Immunogenicity of a Booster Dose of Pneumococcal Conjugate Vaccine, Co-admin With GSK Biologicals' MMRV Vaccine in Children (2nd yr of Life) Primed With the Pneumococcal Conjugate Vaccine in Study 105553.
Brief Summary: This study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of the pneumococcal conjugate vaccine, co-admin with a 1st dose or a 2nd dose of MMRV vaccine at 12-14 or respectively 14-16 months of age in children primed with the pneumococcal conjugate vaccine in study 105553. Antibody persistence will be evaluated at 8-10 months after completion of the 3-dose immunization course in study 105553. The immunogenicity, safety and reactogenicity of the 1st and 2nd dose of MMRV vaccine will also be evaluated when co-admin with the pneumococcal conjugate vaccine between 12-16 months of age.

The study has 3 groups.

* The 1st group will receive the booster dose of pneumococcal conjugate vaccine + 1st dose of MMRV vaccine at 12-14 mo of age and the booster dose of Infanrix hexa™+ 2nd dose of MMRV vaccine at 14-16 mo of age.
* The 2nd group will receive the booster dose of Infanrix hexa™ + 1st dose of MMRV vaccine at 12-14 mo of age and the booster dose of pneumococcal conjugate vaccine + 2nd dose of MMRV vaccine at 14-16 mo of age.
* The 3rd group will receive the booster dose of pneumococcal conjugate vaccine + the booster dose of Infanrix hexa™ at 12-14 mo. Subjects will be offered one dose of Priorix™ and Varilrix™ at 14-16 mo of age, outside the study.


Options:
A: Phase A: Number of Subjects With Confirmed Varicella Case (From 42 days post dose 2 until the end of Phase A)
B: Anti-hepatitis A Virus (HAV) Antibody Concentrations in HAV and HAV+MMR+V Groups. (31 days following the second dose of Havrix®); Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentration Equal or Above the Cut-off Value in HAV and HAV+MMR+V Groups (31 days following the second dose of Havrix®); Number of Subjects Seroconverted for Anti-measle, Anti-mumps and Anti-varicella Antibodies in HAV+MMR+V and MMR+V→HAV Groups (42 days following the administration of M-M-R®II and VARIVAX®); Number of Subjects With Vaccine Response for Anti-rubella Antibodies in HAV+MMR+V and MMR+V→HAV Groups (42 days following administration of M-M-R®II and VARIVAX®)
C: Post vacc: rectal fever >39°C
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Noradrenalin vs Terlipressin in Patients With Hepatorenal Syndrome.A Prospective, Randomized Study
Brief Summary: The purpose of this study is to determine whether noradrenalin is as effective and safe as terlipressin in the treatment of hepatorenal syndrome


Options:
A: Treatment Success (Day 14)
B: Survival
C: Percentage of Participants With Confirmed Hepatorenal Syndrome (HRS) Reversal (within 14 days)
D: Renal function at the beginning and at the end of therapy (two weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Noradrenalin vs Terlipressin in Patients With Hepatorenal Syndrome.A Prospective, Randomized Study
Brief Summary: The purpose of this study is to determine whether noradrenalin is as effective and safe as terlipressin in the treatment of hepatorenal syndrome


Options:
A: Percentage of Participants With Confirmed Hepatorenal Syndrome (HRS) Reversal (within 14 days)
B: Renal function at the beginning and at the end of therapy (two weeks)
C: Treatment Success (Day 14)
D: The primary end point of the study was serum creatinine less than 1.5 mg (15 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Noradrenalin vs Terlipressin in Patients With Hepatorenal Syndrome.A Prospective, Randomized Study
Brief Summary: The purpose of this study is to determine whether noradrenalin is as effective and safe as terlipressin in the treatment of hepatorenal syndrome


Options:
A: Percentage of Participants With Confirmed Hepatorenal Syndrome (HRS) Reversal (within 14 days)
B: Treatment Success (Day 14)
C: Renal function at the beginning and at the end of therapy (two weeks)
D: The primary end point of the study was serum creatinine less than 1.5 mg (15 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled Phase III Study, to Evaluate the Efficacy, Safety and Tolerability of Eltrombopag Olamine (SB-497115-GR), a Thrombopoietin Receptor Agonist, Administered for 6 Months as Oral Tablets Once Daily in Adult Subjects With Previously Treated Chronic ITP.
Brief Summary: The rationale for this Phase III study is to evaluate the 6 month safety and efficacy of eltrombopag in the treatment of previously treated subjects with chronic ITP. The starting dose of eltrombopag, 50 mg, once daily was selected based upon the observed efficacy, safety and pharmacokinetics in a dose-finding Study (TRA100773). This Phase III study is a randomized, double-blind, placebo-controlled, Phase III study, to evaluate efficacy, safety and tolerability of eltrombopag, initially administered as 50 mg oral tablets once daily for six months in adult subjects with previously treated chronic ITP. Subjects will be randomized 2:1, eltrombopag to placebo, and will be stratified based upon splenectomy status, use of ITP medication at baseline and baseline platelet count less than or equal to 15,000/µL. Subjects will receive study medication for 6 months, during which the dose of study medication may be adjusted based upon individual platelet counts. In addition, subjects may taper off concomitant ITP medications and may receive any rescue treatments as dictated by local standard of care. After discontinuation of study medication, subjects will complete follow-up visits at weeks 1, 2, 4 and months 3 and 6.


Options:
A: Treatment response, assessed by the proportion of patients with platelet counts of =50, 000/µL (compared with baseline count of <30, 000/µL) after 42 days of treatment.
B: Percentage of Responders (Baseline; each on-therapy treatment day; Weeks 10, 14, 18, 22, and 26; and Weeks 1, 2, and 4 post-treatment)
C: Number of Participants With Adverse Events (From first dose of study drug through 8 weeks (Part A) or 6 weeks (Part B) after last dose of study drug; 78 days); Number of Participants With Anti-romiplostim or Anti-endogenous Thrombopoietin Neutralizing Antibodies (Assessed on day 29 (Part A only), day 43 (Part B only), and day 78)
D: Number of Participants With Adverse Events (Duration of treatment plus 8 weeks (up to 285 weeks))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to compare the efficacy and safety of intravitreal injection of bevacizumab alone versus bevacizumab combined with triamcinolone for treatment of refractory diabetic macular edema.


Options:
A: Change from Baseline in Visual Acuity (VA) to Month 12 (Baseline, Month 12); Change from Baseline in Visual Acuity (VA) to Month 24 (Baseline, Month 24)
B: Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Month 24 (Baseline to Month 24)
C: Overall Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year (Baseline to 1-year); Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year: Baseline Visual Acuity Letter Score <69 (Baseline to 1-year); Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year: Baseline Visual Acuity Letter Score 78-69 (Baseline to 1-year)
D: Visual acuity; Central macular thickness

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to compare the efficacy and safety of intravitreal injection of bevacizumab alone versus bevacizumab combined with triamcinolone for treatment of refractory diabetic macular edema.


Options:
A: Visual acuity gain (2 years)
B: Visual acuity; Central macular thickness
C: Mean Change in Visual Acuity Letter Score (24 weeks after randomization)
D: visual acuity; central macular thickness

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to compare the efficacy and safety of intravitreal injection of bevacizumab alone versus bevacizumab combined with triamcinolone for treatment of refractory diabetic macular edema.


Options:
A: Visual acuity; Central macular thickness
B: N/A
C: Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Month 24 (Baseline to Month 24)
D: Mean Change in Best Corrected Visual Acuity (BCVA) at Month 6 (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised, Double Blind, Parallel Group Study to Assess the Bronchodilative and Bronchoprotective Properties of SERETIDE DISKUS® Inhaler 50/100 mcg Twice Daily vs FLIXOTIDE® Inhaler 200 mcg Twice Daily
Brief Summary: Comparison of two asthma treatments by lung function measures.


Options:
A: Inflammation: localisation, numbers and profile of neutrophils, eosinophils, macrophages, and CD8+T cells in bronchial biopsy specimens after 6 months and 2.5 years treatment.
B: Eosinophils in induced sputum (as % of Total Cell Count), change from the start of the exacerbation to the end of 14 days treatment
C: Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) (Baseline to Endpoint (13 weeks)); Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1 (Baseline to Endpoint (13 weeks))
D: Specific airway resistance (sRAW kPa.L.s) measured before the study medication dose at the end of treatment (week 4)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised, Double Blind, Parallel Group Study to Assess the Bronchodilative and Bronchoprotective Properties of SERETIDE DISKUS® Inhaler 50/100 mcg Twice Daily vs FLIXOTIDE® Inhaler 200 mcg Twice Daily
Brief Summary: Comparison of two asthma treatments by lung function measures.


Options:
A: Pre-dose FEV1 (Forced Expiratory Volume in the first second) (Week 26); Reduction of moderate and severe asthma exacerbations rate (Week 0 to Week 52)
B: Asthma exacerbations, ECG and Holter monitors, lung function, adverse events, requirement of other asthma therapies and other routine safety assessments. (7 assessments within 12 month treatment period)
C: Specific airway resistance (sRAW kPa.L.s) measured before the study medication dose at the end of treatment (week 4)
D: The primary efficacy endpoint is the change in pre dose Forced Expiratory Volume in one second (FEV1) from baseline to 2-hours post dose FEV1 at Week 12. (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised, Double Blind, Parallel Group Study to Assess the Bronchodilative and Bronchoprotective Properties of SERETIDE DISKUS® Inhaler 50/100 mcg Twice Daily vs FLIXOTIDE® Inhaler 200 mcg Twice Daily
Brief Summary: Comparison of two asthma treatments by lung function measures.


Options:
A: Specific airway resistance (sRAW kPa.L.s) measured before the study medication dose at the end of treatment (week 4)
B: Trough Forced Expiratory Volume in 1 Second (FEV1) at End of Treatment (Week 12) (End of treatment (Week 12))
C: Rate of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in QVA149 and NVA237 Treatment Arms During the Treatment Period. (64 weeks)
D: Trough Forced Expiratory Volume in one second (FEV1) response determined at the end of the 12- week treatment period (week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised, Double Blind, Parallel Group Study to Assess the Bronchodilative and Bronchoprotective Properties of SERETIDE DISKUS® Inhaler 50/100 mcg Twice Daily vs FLIXOTIDE® Inhaler 200 mcg Twice Daily
Brief Summary: Comparison of two asthma treatments by lung function measures.


Options:
A: Inflammation: localisation, numbers and profile of neutrophils, eosinophils, macrophages, and CD8+T cells in bronchial biopsy specimens after 6 months and 2.5 years treatment.
B: Specific airway resistance (sRAW kPa.L.s) measured before the study medication dose at the end of treatment (week 4)
C: Eosinophils in induced sputum (as % of Total Cell Count), change from the start of the exacerbation to the end of 14 days treatment
D: Pre-dose and 1-hour post-dose FEV1 over the 12 months treatment period

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Randomised, Parallel Groups Investigation Into the Effects of Pregabalin, Duloxetine and Amitriptyline on Aspects of Pain, Sleep, and Next Day Performance in Patients Suffering From Diabetic Peripheral Neuropathy
Brief Summary: The purpose of this study is to assess the effectiveness of pregabalin, duloxetine and amitriptyline compared with placebo in reducing pain in diabetic patients as assessed by Brief Pain Inventory (BPI).


Options:
A: Change From Baseline in the Weekly Mean of the 24-Hour Average Pain Score at 8 Weeks (Baseline, 8 weeks (blinded endpoint))
B: Whether there is a reduction in subjective pain as assessed by the Brief Pain Inventory. (December 2008)
C: Visual Analogue Scale for Pain (Baseline, Week 1, 2,4, and 6 weeks); Changes in The Fatigue Severity Scale (FSS) (Baseline, Week 1, 2,4, and 6 weeks); Composite Brief Assessment of Cognition (BAC) Score (Baseline, Week 6)
D: Change in Mean Pain Severity Score From Baseline to 13 Weeks (Baseline and 13 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Randomised, Parallel Groups Investigation Into the Effects of Pregabalin, Duloxetine and Amitriptyline on Aspects of Pain, Sleep, and Next Day Performance in Patients Suffering From Diabetic Peripheral Neuropathy
Brief Summary: The purpose of this study is to assess the effectiveness of pregabalin, duloxetine and amitriptyline compared with placebo in reducing pain in diabetic patients as assessed by Brief Pain Inventory (BPI).


Options:
A: Number of Awakenings After Sleep Onset (NAASO) (4-Week maintenance treatment with milnacipran and placebo); Sleep Efficiency (SE) (4-Week maintenance treatment with milnacipran and placebo); Wake After Sleep Onset (WASO) (4-Week maintenance treatment with milnacipran and placebo)
B: Percent days abstinent from alcohol (PDA) (12 and 24 weeks)
C: Whether there is a reduction in subjective pain as assessed by the Brief Pain Inventory. (December 2008)
D: Mean two-week sleep log estimate of post-treatment sleep continuity (An average of two-weeks post-treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Randomised, Parallel Groups Investigation Into the Effects of Pregabalin, Duloxetine and Amitriptyline on Aspects of Pain, Sleep, and Next Day Performance in Patients Suffering From Diabetic Peripheral Neuropathy
Brief Summary: The purpose of this study is to assess the effectiveness of pregabalin, duloxetine and amitriptyline compared with placebo in reducing pain in diabetic patients as assessed by Brief Pain Inventory (BPI).


Options:
A: Change From Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Average Pain Score During the 8-week Treatment Period (Day 1 through 8 weeks); Change From Baseline in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Week 8 (Baseline, 8 weeks)
B: Change From Baseline (Week 8) in Brief Pain Inventory (BPI) 24-hour Average Pain Item Score at Week 34 Endpoint (Baseline (Week 8), Week 34)
C: Whether there is a reduction in subjective pain as assessed by the Brief Pain Inventory. (December 2008)
D: Patient's Global Impressions of Improvement (PGI-I) at Week 12 (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Randomised, Parallel Groups Investigation Into the Effects of Pregabalin, Duloxetine and Amitriptyline on Aspects of Pain, Sleep, and Next Day Performance in Patients Suffering From Diabetic Peripheral Neuropathy
Brief Summary: The purpose of this study is to assess the effectiveness of pregabalin, duloxetine and amitriptyline compared with placebo in reducing pain in diabetic patients as assessed by Brief Pain Inventory (BPI).


Options:
A: Whether there is a reduction in subjective pain as assessed by the Brief Pain Inventory. (December 2008)
B: Total pain intensity as measured by numeric rating scale 0-10 points. (Median of ratings from last week of each treatment period)
C: Mean Pain Score at Endpoint as Measured by Daily Pain Rating Scale (DPRS) (Up to Week 12)
D: Average Diabetic Peripheral Neuropathy (DPN) Pain Based on a Numeric Rating Scale (NRS) Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period) (End of Period (includes both Visits 5 and 9))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: to compare the effect of intravitreal bevacizumab alone or in combination with triamcinolone acetonide with laser photocoagulation on clinically significant macular edema (CSME)


Options:
A: 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])
B: Change from Baseline in Visual Acuity (VA) to Month 12 (Baseline, Month 12); Change from Baseline in Visual Acuity (VA) to Month 24 (Baseline, Month 24)
C: visual acuity; central macular thickness
D: Overall Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year (Baseline to 1-year); Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year: Baseline Visual Acuity Letter Score <69 (Baseline to 1-year); Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year: Baseline Visual Acuity Letter Score 78-69 (Baseline to 1-year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: to compare the effect of intravitreal bevacizumab alone or in combination with triamcinolone acetonide with laser photocoagulation on clinically significant macular edema (CSME)


Options:
A: Mean Change in Visual Acuity Letter Score (24 weeks after randomization)
B: visual acuity; central macular thickness
C: Visual acuity gain (2 years)
D: Visual acuity; Central macular thickness

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: to compare the effect of intravitreal bevacizumab alone or in combination with triamcinolone acetonide with laser photocoagulation on clinically significant macular edema (CSME)


Options:
A: Change From Baseline in Visual-acuity Score (Continuous) (Baseline and 1 Year)
B: N/A
C: 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])
D: visual acuity; central macular thickness

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Prospective, Double-Blind Controlled Evaluation of the Effectiveness of Caudal Epidural Injections in Lumbar Disc Herniations, Spinal Stenosis, Discogenic Pain, and Post-Lumbar Laminectomy Syndrome
Brief Summary: To demonstrate clinically significant improvements or lack thereof in the caudal epidural patients with our without steroids.

To evaluate differences in outcomes in patients receiving steroids compared to those patients randomized to the local anesthetic group who did not receive steroids.

To assess improvements among patients and compare steroid groups with each other and local anesthetic group.

To evaluate and compare the adverse event profile in all patients


Options:
A: Radicular Pain Visual Analogue Scale (VAS) Score change from baseline (Baseline, 4 weeks, 8 weeks, 12 weeks post injection)
B: Roland Morris (6 weeks)
C: To evaluate for differences between the patients in various groups in the physical function and pain at 1, 3, 6, and 12 months post treatment (1,3,6,12 months)
D: Numerical Rating Leg Pain Score (1 month)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Intravitreal Bevasizumab VS Sham Treatment in Acute BRVO: A Randomized Clinical Trial
Brief Summary: In this study we intend to evaluate the outcome of intravitreal avastin on improving the visual acuity and macular edema and late complications of BRVO like NVD and NVE


Options:
A: Best corrected visual acuity (At 12 week); Macular thickness by OCT (At 12 week)
B: change in central retinal thickness (six months compared to baseline)
C: Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO) (Baseline, 6 Months)
D: Changes in best spectacle-corrected visual acuity (BSCVA) (from baseline to month 6)

Answer: A