TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Randomized, Double Masked, Active Treatment-Controlled Study of the Efficacy and Safety of rhuFab V2 (Ranibizumab) Compared With Verteporfin (Visudyne) Photodynamic Therapy in Subjects With Predominantly Classic Subfoveal Neovascular Age-Related Macular Degeneration
Brief Summary: This is a phase III, multicenter, randomized, double-masked, active treatment-controlled study of intravitreally administered ranibizumab compared with verteporfin (Visudyne) photodynamic therapy (PDT) in treating subfoveal neovascular mascular degeneration.


Options:
A: Change from baseline in the total area of the GA lesion(s) (24 months)
B: N/A
C: Adjusted Annualized Relapse Rate (ARR) at the End of Month 24 (At the end of month 24)
D: Change of geographic atrophy size to baseline (24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Randomized, Double Masked, Active Treatment-Controlled Study of the Efficacy and Safety of rhuFab V2 (Ranibizumab) Compared With Verteporfin (Visudyne) Photodynamic Therapy in Subjects With Predominantly Classic Subfoveal Neovascular Age-Related Macular Degeneration
Brief Summary: This is a phase III, multicenter, randomized, double-masked, active treatment-controlled study of intravitreally administered ranibizumab compared with verteporfin (Visudyne) photodynamic therapy (PDT) in treating subfoveal neovascular mascular degeneration.


Options:
A: N/A
B: N/A
C: N/A
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Randomized, Double Masked, Active Treatment-Controlled Study of the Efficacy and Safety of rhuFab V2 (Ranibizumab) Compared With Verteporfin (Visudyne) Photodynamic Therapy in Subjects With Predominantly Classic Subfoveal Neovascular Age-Related Macular Degeneration
Brief Summary: This is a phase III, multicenter, randomized, double-masked, active treatment-controlled study of intravitreally administered ranibizumab compared with verteporfin (Visudyne) photodynamic therapy (PDT) in treating subfoveal neovascular mascular degeneration.


Options:
A: Mean Change From Baseline Through Week 54 in Distance Visual Acuity (VA) in Subjects With Early and Established CNV Lesions (Baseline through Week 54)
B: Change of visual acuity over time (12 months)
C: N/A
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Randomized, Double Masked, Active Treatment-Controlled Study of the Efficacy and Safety of rhuFab V2 (Ranibizumab) Compared With Verteporfin (Visudyne) Photodynamic Therapy in Subjects With Predominantly Classic Subfoveal Neovascular Age-Related Macular Degeneration
Brief Summary: This is a phase III, multicenter, randomized, double-masked, active treatment-controlled study of intravitreally administered ranibizumab compared with verteporfin (Visudyne) photodynamic therapy (PDT) in treating subfoveal neovascular mascular degeneration.


Options:
A: N/A
B: Mean Visual Acuity; Total number of treatments
C: Preservation of 5Ve isopter Goldmann visual field versus baseline at 1 year (12 and 24 months); Estimate the % of subjects progressing to neovascular glaucoma requiring pan-retinal photocoagulation or glaucoma surgery after treatment with ranibizumab (comparing 0.3mg to 0.5mg doses) (12 and 24 mponths)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Comparative, Open Label Phase III Trial on Efficacy & Safety of Long-term Treatment With ICL670 Compared to Deferoxamine in Beta-thalassemia Patients With Transfusional Hemosiderosis
Brief Summary: The purpose of this study is to deterimine if the new orally active iron chelator, ICL670, is as effective and as safe as deferoxamine in preventing accumulation of iron in the body while a patient is undergoing repeated blood transfusions.


Options:
A: Clinical efficacy (Iron balance and liver iron concentration) (At baseline and at 12 months)
B: Demonstrate non-inferiority to deferoxamine in its effects on liver iron content (LIC)
C: Core Study: Change From Baseline in Myocardial T2* (Magnetic Resonance T2-star (T2*) Technique for the Measurement of Tissue Iron) After 12 Months Treatment (12 Month)
D: Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event (up to 5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Comparative, Open Label Phase III Trial on Efficacy & Safety of Long-term Treatment With ICL670 Compared to Deferoxamine in Beta-thalassemia Patients With Transfusional Hemosiderosis
Brief Summary: The purpose of this study is to deterimine if the new orally active iron chelator, ICL670, is as effective and as safe as deferoxamine in preventing accumulation of iron in the body while a patient is undergoing repeated blood transfusions.


Options:
A: Clinical efficacy (Iron balance and liver iron concentration) (At baseline and at 12 months)
B: Myocardial T2*
C: Demonstrate non-inferiority to deferoxamine in its effects on liver iron content (LIC)
D: difference between multiple observations of the serum ferritin concentrations (five-year treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Comparative, Open Label Phase III Trial on Efficacy & Safety of Long-term Treatment With ICL670 Compared to Deferoxamine in Beta-thalassemia Patients With Transfusional Hemosiderosis
Brief Summary: The purpose of this study is to deterimine if the new orally active iron chelator, ICL670, is as effective and as safe as deferoxamine in preventing accumulation of iron in the body while a patient is undergoing repeated blood transfusions.


Options:
A: Area Under the Curve of Deferasirox After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose); Half-Life of Deferasirox (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose.); Volume of Distribution/Bioavailability of Deferasirox After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose); Volume of Distribution/Bioavailability of Deferasirox After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose); Clearance/Bioavailability of Deferasirox in Patients With Poor Response to Deferasirox Compared to Patients With Good Response After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose.)
B: Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event (up to 5 years)
C: to assess efficacy of combining DFP and deferasirox compared to combined DFP and DFO in decreasing the serum ferritin level in conditions with severe chronic iron overload. (12 months)
D: Demonstrate non-inferiority to deferoxamine in its effects on liver iron content (LIC)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double Blind Study to Evaluate the Efficacy and Safety of Two Atypical Antipsychotics vs. Placebo in Patients With an Acute Exacerbation of Either Schizophrenia or Schizoaffective Disorder
Brief Summary: A study to evaluate the efficacy and safety of two atypical antipsychotics vs. placebo in patients with an acute exacerbation of either schizophrenia or schizoaffective disorder


Options:
A: 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)
B: PANSS-total score
C: Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score (Baseline, Week 6)
D: Efficacy of combined risperidone and quetiapine groups versus placebo based on change in psychotic symptoms scale from baseline to two weeks.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This project will determine whether exposing youths to a "fitogenic" after-school environment that emphasizes vigorous exercise and healthy snacks will have a favorable effect on body composition (i.e., less fat tissue and more lean tissue), cardiovascular fitness and cardiovascular disease risk profile. The environmental intervention will be provided in nine schools in Augusta, Georgia, with another nine schools serving as non-intervention comparison schools. Children in the 3rd grade will be recruited to participate. They will be followed for 3 years, through the 5th grade. Measurements will be made at the beginning and end of each school year. The 2-hour after-school intervention will be offered every school day. It will consist of three components: (1) homework assistance; (2) a healthy snack; and (3) exercise designed to improve skills and fitness.


Options:
A: N/A
B: Change in BMI z-score (Baseline (0 months) and 9 months)
C: Change in physical activity (Participants' physical activity will be measure over the course of 5 consecutive school days pre-intervention and 5 consecutive school days post-intervention)
D: Change in proportion of children meeting physical activity policy (Baseline, Fall of Year 2, and Fall of Year 3)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This project will determine whether exposing youths to a "fitogenic" after-school environment that emphasizes vigorous exercise and healthy snacks will have a favorable effect on body composition (i.e., less fat tissue and more lean tissue), cardiovascular fitness and cardiovascular disease risk profile. The environmental intervention will be provided in nine schools in Augusta, Georgia, with another nine schools serving as non-intervention comparison schools. Children in the 3rd grade will be recruited to participate. They will be followed for 3 years, through the 5th grade. Measurements will be made at the beginning and end of each school year. The 2-hour after-school intervention will be offered every school day. It will consist of three components: (1) homework assistance; (2) a healthy snack; and (3) exercise designed to improve skills and fitness.


Options:
A: Growth trajectories (using BMI, waist circumference), body composition (3 months)
B: N/A
C: Skin-fold thickness (1 year)
D: Body fat percentage (One year (interim analysis))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Trial Of Single Agent Doxorubicin Versus Doxorubicin Plus Ifosfamide In The First Line Treatment Of Advanced Or Metastatic Soft Tissue Sarcoma
Brief Summary: RATIONALE: Drugs used in chemotherapy such as doxorubicin and ifosfamide use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors, such as pegfilgrastim, cause the body to make blood cells. It is not yet known whether doxorubicin alone is more effective with or without ifosfamide and pegfilgrastim in treating soft tissue sarcoma.

PURPOSE: This randomized phase III trial is studying giving doxorubicin alone to see how well it works compared to giving doxorubicin together with ifosfamide and pegfilgrastim in treating patients with locally advanced or metastatic soft tissue sarcoma.


Options:
A: N/A
B: Overall survival
C: Progression Free Survival rate at 6 months (6 months from registration into the study)
D: Event-free Survival (5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Intensity Modulated Radiotherapy Dose Escalation Trial for Prostate Cancer Using Hypofractionation
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays and other sources of radiation to kill tumor cells. It is not yet known which radiation therapy regimen is more effective in treating prostate cancer.

PURPOSE: This randomized phase III trial is comparing two different regimens of radiation therapy to see how well they work in treating patients with stage II or stage III prostate cancer.


Options:
A: Maximum Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After Radiotherapy (RT) (During radiation therapy and up to 6 weeks post radiation therapy)
B: proctitis and cystitis (3 years)
C: Freedom from biochemical and/or disease failure rates (weekly during treatment, at 3 months, 6 months or 2 years then yearly)
D: testing the efficacy of probiotics Bifilact®, in comparison to a placebo to assess its ability to prevent or delay the incidence of moderate or severe symptoms of diarrhea during the period of treatment by radiotherapy (day 1-60)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Niacin ER/Lovastatin on Peak Walking Time and Claudication Onset Time in Patients With Intermittent Claudication
Brief Summary: The purpose of this study is to evaluate if Niacin ER/Lovastatin, at two different doses, compared to diet control (this group will receive a tablet containing 50 mg. of immediate-release niacin) is a safe and effective medicine in subjects with leg pain caused by a narrowing of their leg arteries, a condition called intermittent claudication.

At least 366 subjects with leg pain caused by a narrowing of their leg arteries will participate in this study.

Niacin ER/Lovastatin is a combination of two FDA (United States Food and Drug Administration) approved cholesterol modifying medications: Niaspan® (extended-release niacin) and lovastatin, a statin (the same medicine found in Mevacor®). Niacin ER/Lovastatin was approved by the FDA under the name of Advicor® for use in the treatment of elevated cholesterol. The use of Niacin ER/Lovastatin in the treatment of peripheral arterial disease and symptomatic relief of intermittent claudication is considered investigational. An investigational use is one that is not approved by the FDA.


Options:
A: Percent Change at Week (Wk) 12 Compared to Baseline (Bl) in Low-density Lipoprotein Cholesterol in Patients With Type 2 Diabetes When Compared to Placebo (Baseline and 12 Weeks)
B: Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Baseline and 24 Weeks); Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Baseline and 24 weeks)
C: Regression of artheriosclerotic plaque measured using functional magnetic resonance imaging.
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Van Gogh-PE Trial, a Multicenter, International, Randomized, Open-Label, Assessor-Blind, Non-Inferiority Study Comparing the Efficacy and Safety of Once-Weekly Subcutaneous SR34006 With the Combination of (LMW)Heparin and Vitamin K Antagonist (VKA) in the Treatment of Acute Symptomatic Pulmonary Embolism
Brief Summary: Patients who have a pulmonary embolism (blood clot in the lung) will be treated in this study. The purpose of the study is to compare the safety and effectiveness of a new injectable anticoagulant (blood-thinning) drug, SR34006, with the standard way of treating a pulmonary embolism. The standard treatment includes injections or infusions of an anticoagulant drug, (LMW)heparin, for about a week followed by anticoagulant tablets (warfarin or acenocoumarol) which are taken by mouth.

Assignment to either SR34006 or (LMW)heparin plus warfarin or acenocoumarol will be purely by chance and will be known by both patients and their doctors.


Options:
A: symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months.
B: Number of Participants With Venous Thromboembolisms and/or Major Hemorrhages to Day 11 (11 days)
C: Bioequipotency sub-study: idrabiotaparinux/idraparinux ratio for pharmacodynamic exposure parameters (Day 183); Avidin neutralizing effect substudy: decrease in anti-Xa activity between the start and end of the avidin infusion (Day 183 to Day 188)
D: Incidence of Any Adjudicated Bleeding Events (14 days); Incidence of Adverse Events (1 month); Incidence of Adverse Drug Reactions (1 month); Plasma Concentration of DU-176b (14 days); Plasma Concentration of D21-2393 (14 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Van Gogh-PE Trial, a Multicenter, International, Randomized, Open-Label, Assessor-Blind, Non-Inferiority Study Comparing the Efficacy and Safety of Once-Weekly Subcutaneous SR34006 With the Combination of (LMW)Heparin and Vitamin K Antagonist (VKA) in the Treatment of Acute Symptomatic Pulmonary Embolism
Brief Summary: Patients who have a pulmonary embolism (blood clot in the lung) will be treated in this study. The purpose of the study is to compare the safety and effectiveness of a new injectable anticoagulant (blood-thinning) drug, SR34006, with the standard way of treating a pulmonary embolism. The standard treatment includes injections or infusions of an anticoagulant drug, (LMW)heparin, for about a week followed by anticoagulant tablets (warfarin or acenocoumarol) which are taken by mouth.

Assignment to either SR34006 or (LMW)heparin plus warfarin or acenocoumarol will be purely by chance and will be known by both patients and their doctors.


Options:
A: Recurrence of symptomatic, fatal or not, VTE (PE or DVT) as confirmed by a Central Independent Adjudication Committee (CIAC) (3 months)
B: Bioequipotency sub-study: idrabiotaparinux/idraparinux ratio for pharmacodynamic exposure parameters (Day 183); Avidin neutralizing effect substudy: decrease in anti-Xa activity between the start and end of the avidin infusion (Day 183 to Day 188)
C: symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months
D: symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Generic Database: A Survey of Morbidity and Mortality in Very Low Birth Weight Infants
Brief Summary: The Generic Database (GDB) is a registry of very low birth weight infants born alive in NICHD Neonatal Research Network (NRN) centers. The GDB collects observational baseline data on both mothers and infants, and the therapies used and outcomes of the infants. The information collected is not specific to a disease or treatment (i.e., it is "generic"). Data are analyzed to find associations and trends between baseline information, treatments, and infant outcome, and to develop future NRN trials.


Options:
A: To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform manner (Longitudinal database currently funded through 3/31/2030)
B: Heart rate (Change from Baseline Heart rate at 3 minutes before, during, and at the first and 10th minute after heel lance procedure); Respiratory rate (Change from Baseline Respiratory rate at 3 minutes before, during, and at the first and 10th minute after heel lance procedure); Oxygen Saturation (Change from Baseline Oxygen Saturation at 3 minutes before, during, and at the first and 10th minute after heel lance procedure); Respond of Pain (Change from Baseline Pain at 3 minutes before, during, and at the first and 10th minute after heel lance procedure)
C: Change in Heart Rate Variability (Pre intervention (baseline), during the intervention and immediately after the intervention)
D: Feasibility and acceptability of the NeuroN-QI and the study procedures as assessed by a self-completed questionnaire (mothers) and a logbook (RA) (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Generic Database: A Survey of Morbidity and Mortality in Very Low Birth Weight Infants
Brief Summary: The Generic Database (GDB) is a registry of very low birth weight infants born alive in NICHD Neonatal Research Network (NRN) centers. The GDB collects observational baseline data on both mothers and infants, and the therapies used and outcomes of the infants. The information collected is not specific to a disease or treatment (i.e., it is "generic"). Data are analyzed to find associations and trends between baseline information, treatments, and infant outcome, and to develop future NRN trials.


Options:
A: Neonatal Composite Outcome (72 hours of life)
B: Incidence of respiratory morbidity (72 hours after birth)
C: Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity) (Birth to 28 days)
D: To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform manner (Longitudinal database currently funded through 3/31/2030)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Generic Database: A Survey of Morbidity and Mortality in Very Low Birth Weight Infants
Brief Summary: The Generic Database (GDB) is a registry of very low birth weight infants born alive in NICHD Neonatal Research Network (NRN) centers. The GDB collects observational baseline data on both mothers and infants, and the therapies used and outcomes of the infants. The information collected is not specific to a disease or treatment (i.e., it is "generic"). Data are analyzed to find associations and trends between baseline information, treatments, and infant outcome, and to develop future NRN trials.


Options:
A: Adverse event rates occurring in the pilot study population will be compared between the cord blood cell recipients and historical controls. (during infusions: first 18 postnatal days)
B: Number of subjects with Adverse Drug Reaction (at corrected age of 21 months (±3 months))
C: To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform manner (Longitudinal database currently funded through 3/31/2030)
D: Number of participant with adverse reaction (12 weeks from the day of treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Generic Database: A Survey of Morbidity and Mortality in Very Low Birth Weight Infants
Brief Summary: The Generic Database (GDB) is a registry of very low birth weight infants born alive in NICHD Neonatal Research Network (NRN) centers. The GDB collects observational baseline data on both mothers and infants, and the therapies used and outcomes of the infants. The information collected is not specific to a disease or treatment (i.e., it is "generic"). Data are analyzed to find associations and trends between baseline information, treatments, and infant outcome, and to develop future NRN trials.


Options:
A: Incidence of respiratory morbidity (72 hours after birth)
B: To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform manner (Longitudinal database currently funded through 3/31/2030)
C: Neonatal Composite Outcome (72 hours of life)
D: Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity) (Birth to 28 days)

Answer: B