TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Feasibility of Correcting Refractive Error From a Limited Inventory of Ready-made Spectacles: Wearer Retention, Vision Function, Quality of Life and Cost
Brief Summary: This research project will compare two methods of correcting refractive error (long or short-sightedness) with spectacle lenses. The primary outcome is the proportion of the population requiring spectacle correction who's needs are met through each scheme. Secondary outcomes are the cost effectiveness of these schemes and development of guidelines for identification of those amongst the population suitable for 'ready-made' spectacles.

There are two sites involved in this research. Those with uncorrected refractive error will be identified by their distance vision. Those who have impaired vision (at least 20/40) which improves with spectacles will be invited to participate in this research. Participants will be randomly allocated to one of two groups. The first group will receive spectacles with full correction in both eyes and the second group will receive spectacles from a limited inventory. The two schemes will be compared by how many people continue to use the spectacles, vision with the new spectacles, change in the level of visual functioning and quality of life after wearing new spectacles for one month. At the one month visit, if the spectacles provided are not useful, one new pair of custom spectacles will be dispensed.


Options:
A: Wearer retention (% wearing at 1 month), vision (logMAR), visual function (0-100), quality of life (0-100) (a 1-month period of spectacle wear)
B: Axial Length of the Eye (Baseline and every 6 months post-baseline up to 18 months); Spherical Equivalent Refractive Error (Baseline and every 6 months up to 18 months)
C: Change in Axial Length (Baseline, 7 months, and 14 months after baseline)
D: Cycloplegic refraction (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Liposomal Doxorubicin Versus Carboplatin/Paclitaxel in Patients With Ovarian Cancer Recurrence Between 6 and 12 Months After Previous Platinum Based Therapy: Phase III Randomized Multicenter Study Amendment Title Protocol Version 2.0: Phase III International Multicenter Randomized Study Testing the Effect on Survival of Prolonging Platinum-free Interval in Patients With Ovarian Cancer Recurring Between 6 and 12 Months After Previous Platinum Based Chemotherapy.
Brief Summary: This study aims to test the hypothesis that the artificial prolongation of the platinum-free interval with a non-platinum treatment will improve the effectiveness of overall therapy in patients with ovarian cancer progression occurring 6-12 months after first-line treatment with a platinum-derivative.


Options:
A: overall survival (18 months)
B: Progression free survival (30 months)
C: Overall Survival (OS) (From date of randomizationrandomization to date of death from any cause assessed up to 40 months); Progression-free survival (From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs earlier, assessed up to 40 months)
D: Progression-free Survival (Duration of time from start of treatment to time of progression, approximately 4 years and 6 months.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Double-Blind Comparative Trial of Bicalutamide (Casodex™) Versus Placebo in Patients With Early Prostate Cancer.
Brief Summary: The purpose of this trial is to study the effect - in terms of time to progression and overall survival - of 2 years of adjuvant bicalutamide 150mg monotherapy, versus placebo, in subjects with histologically or cytologically confirmed non-metastatic adenocarcinoma of the prostate gland.


Options:
A: Quality of life (using Rand 36-Item Health Survey SF-36) (3 monthly for 1 year)
B: Time to clinical progression (Throughout study period); Overall patient survival (Throughout study period)
C: Survival (Throughout study period); Time to clinical progression (Throughout study period)
D: Time to clinical progression (Throughout study period); Tolerability in terms of adverse events and laboratory parameters (Throughout study period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Double-Blind Comparative Trial of Bicalutamide (Casodex™) Versus Placebo in Patients With Early Prostate Cancer.
Brief Summary: The purpose of this trial is to study the effect - in terms of time to progression and overall survival - of 2 years of adjuvant bicalutamide 150mg monotherapy, versus placebo, in subjects with histologically or cytologically confirmed non-metastatic adenocarcinoma of the prostate gland.


Options:
A: Time to clinical progression (Throughout study period); Overall patient survival (Throughout study period)
B: Death from any cause at 8 years
C: Time to clinical progression (Throughout study period); Tolerability in terms of adverse events and laboratory parameters (Throughout study period)
D: Survival (Throughout study period); Time to clinical progression (Throughout study period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-month, Multicenter, Randomized, Open-label Study to Investigate Efficacy and Safety of Concentration Controlled Everolimus With Reduced Dose Cyclosporine A Versus Mycophenolate Mofetil With Standard Dose Cyclosporine A in de Novo Renal Transplant Adult Recipients Treated With Basiliximab and Corticosteroids
Brief Summary: The 12 Month Core Study (CRAD001A1202) was designed to evaluate the efficacy and safety comparing concentration-controlled everolimus (1.5 mg/day starting dose) with reduced dose cyclosporine and corticosteroids versus 2 g/day mycophenolate mofetil (MMF) with standard dose cyclosporine and corticosteroids in de novo renal transplant recipients.

Extension Study (CRAD001A1202E1): Until 24 months after renal transplantation, the study was designed to evaluate the long-term safety and efficacy comparing concentration-controlled everolimus with reduced dose cyclosporine (Neoral®) and corticosteroids versus mycophenolate mofetil with standard dose Neoral® and corticosteroids in de novo renal transplant recipients. Beyond 24 months after renal transplantation, the study was designed to provide everolimus treatment for patients in everolimus group until everolimus is approved and marketed in Japan.


Options:
A: Core Study: Number of Patients With Composite Efficacy Endpoint (12 months); Extension Study: Renal Function Measured by Calculated Glomerular Filtration Rate (cGFR) Using the Modification of Diet in Renal Disease (MDRD) Formula (Month 24); Extension Study: Renal Function Measured by Calculated Glomerular Filtration Rate (cGFR) Using the Modification of Diet in Renal Disease (MDRD) Formula (Month 48)
B: Number of Participants With Incidence of Composite Efficacy Failure (12 Months)
C: incidence of CMV infection or disease (1 year)
D: Plasma Creatinine (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-month, Multicenter, Randomized, Open-label Study to Investigate Efficacy and Safety of Concentration Controlled Everolimus With Reduced Dose Cyclosporine A Versus Mycophenolate Mofetil With Standard Dose Cyclosporine A in de Novo Renal Transplant Adult Recipients Treated With Basiliximab and Corticosteroids
Brief Summary: The 12 Month Core Study (CRAD001A1202) was designed to evaluate the efficacy and safety comparing concentration-controlled everolimus (1.5 mg/day starting dose) with reduced dose cyclosporine and corticosteroids versus 2 g/day mycophenolate mofetil (MMF) with standard dose cyclosporine and corticosteroids in de novo renal transplant recipients.

Extension Study (CRAD001A1202E1): Until 24 months after renal transplantation, the study was designed to evaluate the long-term safety and efficacy comparing concentration-controlled everolimus with reduced dose cyclosporine (Neoral®) and corticosteroids versus mycophenolate mofetil with standard dose Neoral® and corticosteroids in de novo renal transplant recipients. Beyond 24 months after renal transplantation, the study was designed to provide everolimus treatment for patients in everolimus group until everolimus is approved and marketed in Japan.


Options:
A: Core Study: Number of Patients With Composite Efficacy Endpoint (12 months); Extension Study: Renal Function Measured by Calculated Glomerular Filtration Rate (cGFR) Using the Modification of Diet in Renal Disease (MDRD) Formula (Month 24); Extension Study: Renal Function Measured by Calculated Glomerular Filtration Rate (cGFR) Using the Modification of Diet in Renal Disease (MDRD) Formula (Month 48)
B: Plasma Creatinine (6 months)
C: Reduced Exposure Cyclosporine in Renal Transplant Recipients (12 months after the time of kidney transplantation)
D: Equivalence of graft survival at month 12

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multinational, Randomised, Double-blind, Fixed-dose, Bifeprunox Study Combining a 12-Week Placebo-controlled, Quetiapine-referenced Phase With a 12-month Quetiapine-controlled Phase in Patients With Schizophrenia
Brief Summary: The primary purpose of the study is to evaluate the efficacy of bifeprunox in the maintenance phase of schizophrenia compared to placebo.


Options:
A: relapse (at least one year)
B: Time to Exacerbation of Psychotic Symptoms/Impending Relapse (Baseline of the depot maintenance phase to the end of the study (Week 52))
C: The difference in change from baseline to the 12-week time point between bifeprunox and placebo using the Positive and Negative Syndrome Scale (PANSS). (12 weeks)
D: The difference in change from baseline to the 12-week time point between bifeprunox and placebo using the Positive and Negative Syndrome Scale (PANSS). (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Controlled, Superiority Evaluation of Fibrin Patch as an Adjunct to Control Soft Tissue Bleeding During Abdominal, Retroperitoneal, Pelvic, and Thoracic Surgery
Brief Summary: The effectiveness objective of this study is to evaluate whether Fibrin Patch is superior to SURGICEL™ as an adjunct to achieving hemostasis during surgical procedures involving soft tissue bleeding in abdominal, pelvic, retroperitoneal and (non-cardiac) thoracic surgery.


Options:
A: Intraoperative blood loss (End of surgery (last suture))
B: Proportion of Subjects Achieving Hemostatic Success (Intra-operative)
C: Death in hospital within four weeks of injury (causes of death will be described to assess whether deaths were due to haemorrhage or vascular occlusion). (Death, discharge or four weeks post randomisation whichever occurs first.)
D: Blood transfusion rate (Hospital stay (3-7 days))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Controlled, Open Label Study of the Safety and Efficacy of a Topical Gentamicin Collagen Sponge Combined With An Antibiotic Compared to Antibiotic Therapy Alone in Diabetic Patients With Moderately Infected Foot Ulcers
Brief Summary: The purpose of this study is to determine whether the gentamicin-collagen sponge when combined with standard daily wound care and an oral antibiotic (levofloxacin) is safe and effective in treating moderately infected skin ulcers compared to treatment only with standard daily wound care and an oral antibiotic (levofloxacin).


Options:
A: Number of Participants With a Clinical Cure at Visit 3 (Day 7) (Day 7 of treatment)
B: Reduction in clinical signs and symptoms of infection (Study day 10)
C: Number of healing patients (12 weeks)
D: Reduction in clinical signs and symptoms of the infection (Study day 10)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Effects of MEDI-563, A Humanized Anti-Interleukin-5 Receptor Alpha Monoclonal Antibody, on Airway Eosinophils in Adults With Atopic Asthma
Brief Summary: Evaluate the safety and tolerability of MEDI-563 in adults with asthma and the effects of MEDI-563 on eosinophil counts in airway mucosal biopsies


Options:
A: Percentage Reduction in Final OCS Dose Compared With Baseline While Maintaining Asthma Control (Week 28)
B: Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (L) at Week 12 (Baseline, Week 4, Week 8 and Week 12)
C: Safety and tolerability in healthy volunteers.Assessed using clinical safety assessments and blood and urine analysis (Throughout the study); Safety and tolerability in mild asthmatics.Assessed using clinical safety assessments and blood and urine analysis. (Throughout the study)
D: Evaluate the safety and tolerability of MEDI-563 in adults with atopic asthma and evaluate the effects of MEDI-563 on eosinophil counts in airway mucosal biopsies 28 days after completion of dosing in adults with atopic asthma. (Study Day 84 or Day 140 - (dose-driven))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Effects of MEDI-563, A Humanized Anti-Interleukin-5 Receptor Alpha Monoclonal Antibody, on Airway Eosinophils in Adults With Atopic Asthma
Brief Summary: Evaluate the safety and tolerability of MEDI-563 in adults with asthma and the effects of MEDI-563 on eosinophil counts in airway mucosal biopsies


Options:
A: Change From Baseline In Forced Expiratory Volume In 1 Second (FEV1) Over 16 Weeks Using Mixed Model for Repeated Measures (Day 0 (baseline, pre-dose), Weeks 4, 8, 12 and 16)
B: Evaluate the safety and tolerability of MEDI-563 in adults with atopic asthma and evaluate the effects of MEDI-563 on eosinophil counts in airway mucosal biopsies 28 days after completion of dosing in adults with atopic asthma. (Study Day 84 or Day 140 - (dose-driven))
C: Number of Participants With the Indicated Percent Reduction From Baseline in Oral Corticosteroid (OCS) Dose During Weeks 20 to 24 While Maintaining Asthma Control (Baseline; Weeks 20 to 24)
D: Rate of asthma exacerbations during the 52-week placebo-controlled period (weeks 0-52)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Single Arm, Open Label Study to Assess the Efficacy, Safety, and Tolerability of Once-Monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia
Brief Summary: This single-arm study will assess the efficacy and safety of monthly administration of intravenous methoxy polyethylene glycol-epoetin beta (CERA/Mircera) for the maintenance of hemoglobin (Hb) levels in participants on dialysis with chronic renal anemia in routine clinical practice in Hungary. Participants currently receiving maintenance treatment with intravenous epoetin or darbepoetin will receive monthly injections of Mircera, with the starting dose derived from the erythropoiesis-stimulating agent (ESA) dose they had been receiving.


Options:
A: Percentage of Participants Maintaining Average Hemoglobin Concentration Within +/-1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range (Week 17 up to Week 24)
B: Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb or Within Target Range During the Efficacy Evaluation Period (EEP) (At Weeks -4, -3, -2, -1, 0; pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24)
C: Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb and Within Target Range During the Efficacy Evaluation Period (EEP) (Weeks -4, -3, -2, and -1; pre-dose (0 hours) during Weeks 18, 20, 22, and 24)
D: Percentage of Participants Who Maintained Average Hemoglobin (Hb) Concentration Within Plus Minus (+/-) 1 Grams Per Deciliter (g/dL) of Their Reference Hb and Between 10 and 12 g/dL During the EEP (EEP (Week 16 to 23))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Event-driven, Phase III Study to Assess the Effects of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension
Brief Summary: The AC-055-302/SERAPHIN study will be an event-driven Phase III study, comparing two different doses of macitentan (ACT-064992) (3 and 10 mg) vs placebo in patients with symptomatic PAH. The main study objective is to demonstrate that macitentan (ACT-064992) prolongs time to the first morbidity or mortality event, and to evaluate the benefit/risk profile of macitentan (ACT-064992) in the treatment of patients with symptomatic PAH.


Options:
A: Safety; Standard safety data; Efficacy; 6-Minute Walk Test; BORG Dyspnoea Score; WHO Functional Class; Quality of Life SF-36 and EQ-5D
B: Combined Outcome End-Point: all-cause mortality or hospital admission for heart failure, worsening of World Health Organization (WHO) functional class, or of the patient global assessment score (Six months)
C: Percent Change in Mean Pulmonary Artery Pressure in the Whole Cohort. (Baseline and 60 minutes after drug administered)
D: Time to First Confirmed Morbidity or Mortality Event up to the End of Treatment (Kaplan-Meier Estimate of Patients Without a Morbidity or Mortality Event) (Up to end of treatment (data presented up to month 36))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Event-driven, Phase III Study to Assess the Effects of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension
Brief Summary: The AC-055-302/SERAPHIN study will be an event-driven Phase III study, comparing two different doses of macitentan (ACT-064992) (3 and 10 mg) vs placebo in patients with symptomatic PAH. The main study objective is to demonstrate that macitentan (ACT-064992) prolongs time to the first morbidity or mortality event, and to evaluate the benefit/risk profile of macitentan (ACT-064992) in the treatment of patients with symptomatic PAH.


Options:
A: Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Core (6 months); Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Extension (72 months); Change From Baseline of Six Minute Walk Test - Total Distance Walked at Different Time Periods (Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)); Change From Baseline of Six Minute Walk Test - Number of Stops at Different Time Periods (Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)); Change From Baseline of Six Minute Walk Test - Total Duration of Stops at Different Time Periods (Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24))
B: change from baseline in 6-min-walk distance (6-MWD) (12 weeks)
C: 6 minutes walking distance
D: Time to First Confirmed Morbidity or Mortality Event up to the End of Treatment (Kaplan-Meier Estimate of Patients Without a Morbidity or Mortality Event) (Up to end of treatment (data presented up to month 36))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Using the Telephone to Improve Care in Childhood Asthma
Brief Summary: Asthma is the most common chronic disease of childhood and a major cause of morbidity in the United States. If asthma symptoms are controlled, a child with asthma can stay well and lead a normal life. Daily use of inhaled steroids controls symptoms and reduces morbidity and emergent health care utilization in children with persistent asthma, and is safe for long-term use. However, inhaled steroids are underused in community asthma care.

The Telephone Asthma Program (TAP) is a series of brief, telephone calls with a trained coach to help the parent manage the child's asthma care. The coach will teach self-management skills, help the parent to use the child's asthma medicines effectively, provide support and remind the parent to go for follow-up care with the pediatrician. We hypothesized that the Telephone Asthma Program will reduce the incidence of acute exacerbations of asthma that require emergent care, improve the quality of life of children with asthma and their parents, and increase the daily use of inhaled steroids in children with persistent asthma. We evaluated the Telephone Asthma Program in a randomized controlled trial involving 362 children aged 5 to 12 years old cared for by community pediatricians. Eligible children were randomized to the TAP program or usual care by their pediatrician.


Options:
A: Change in baseline of Diabetes Knowledge (Baseline and 14 weeks)
B: Parental asthma-related quality of life (one year); Urgent care events for asthma (One year)
C: Change in Percentage of participants using controller medications for asthma from baseline to 12 month follow-up (Baseline, 12)
D: Parent Report Measures (4 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Using the Telephone to Improve Care in Childhood Asthma
Brief Summary: Asthma is the most common chronic disease of childhood and a major cause of morbidity in the United States. If asthma symptoms are controlled, a child with asthma can stay well and lead a normal life. Daily use of inhaled steroids controls symptoms and reduces morbidity and emergent health care utilization in children with persistent asthma, and is safe for long-term use. However, inhaled steroids are underused in community asthma care.

The Telephone Asthma Program (TAP) is a series of brief, telephone calls with a trained coach to help the parent manage the child's asthma care. The coach will teach self-management skills, help the parent to use the child's asthma medicines effectively, provide support and remind the parent to go for follow-up care with the pediatrician. We hypothesized that the Telephone Asthma Program will reduce the incidence of acute exacerbations of asthma that require emergent care, improve the quality of life of children with asthma and their parents, and increase the daily use of inhaled steroids in children with persistent asthma. We evaluated the Telephone Asthma Program in a randomized controlled trial involving 362 children aged 5 to 12 years old cared for by community pediatricians. Eligible children were randomized to the TAP program or usual care by their pediatrician.


Options:
A: Emergency department visits - 1st time point (12months prior to baseline interview); Emergency Department Visits -2nd time point (Interval between baseline interview and 12 month interview); Emergency Department Visits - 3rd time point (Interval between 12 month and 24 month telephone interview)
B: change in asthma control between baseline and six months as measured by ACQ.24 The ACQ measures clinical goals of asthma management on a scale: 0 (good control) to 6, is responsive to change,24 with a intra-individual minimum important difference (6 months)
C: Parental asthma-related quality of life (one year); Urgent care events for asthma (One year)
D: Percentage Changed in Adherence Score (Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores); Number of Symptom-free Days (Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores)

Answer: C