TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Trial Comparing Nicotine Inhaler Versus Bupropion Versus Nicotine Inhaler Plus Bupropion For Smoking Cessation Efficacy And Relapse Prevention
Brief Summary: RATIONALE: Use of a nicotine inhaler and/or bupropion may be effective in helping people stop smoking and prevent them from starting smoking again. It is not yet known whether a nicotine inhaler or bupropion are more effective alone or combined for stopping smoking.

PURPOSE: Randomized phase III trial to compare the effectiveness of the nicotine inhaler or bupropion alone to that of the nicotine inhaler combined with bupropion in helping people to stop smoking and prevent starting smoking again.


Options:
A: Biochemically Verified 7-day Point Prevalence Abstinence (End of Treatment (week 24))
B: Prevention in relapse (Up to 6 months)
C: Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking (Week 15 - 24)
D: Continuous 4-week Abstinence From Smoking Between Weeks 8-11 After the Quit Date (Through the End of Treatment) (weeks 8-11 after quit date)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Trial Comparing Nicotine Inhaler Versus Bupropion Versus Nicotine Inhaler Plus Bupropion For Smoking Cessation Efficacy And Relapse Prevention
Brief Summary: RATIONALE: Use of a nicotine inhaler and/or bupropion may be effective in helping people stop smoking and prevent them from starting smoking again. It is not yet known whether a nicotine inhaler or bupropion are more effective alone or combined for stopping smoking.

PURPOSE: Randomized phase III trial to compare the effectiveness of the nicotine inhaler or bupropion alone to that of the nicotine inhaler combined with bupropion in helping people to stop smoking and prevent starting smoking again.


Options:
A: Prevention in relapse (Up to 6 months)
B: Percent Treatment Sessions Attended (52 weeks)
C: Quit Rate (4 months)
D: 7-day Point Prevalence All Tobacco Abstinence (12 weeks - end of treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Double-Blind Study Of Depot Octreotide Versus Placebo In The Prevention Of Acute Diarrhea In Patients Receiving Pelvic Radiation Therapy
Brief Summary: RATIONALE: Octreotide may be effective in preventing or controlling diarrhea in patients who are undergoing radiation therapy to the pelvis. It is not yet known whether octreotide is effective for diarrhea.

PURPOSE: Randomized phase III trial to determine the effectiveness of octreotide in preventing diarrhea in patients who are undergoing radiation therapy to the pelvis.


Options:
A: Reduction of diarrhea as measured by NCI CTC version 2.0 weekly during pelvic radiotherapy (Up to 2 years)
B: 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)
C: 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)
D: Effect of Soy Isoflavones on Serum Testosterone Levels. (Two weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized Study Of High Dose 3D-CRT/IMRT Versus Standard Dose 3D-CRT/IMRT In Patients Treated For Localized Prostate Cancer
Brief Summary: RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which dose of radiation therapy is more effective in treating stage II prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different doses of specialized radiation therapy in treating patients who have stage II prostate cancer.


Options:
A: N/A
B: Biochemical or clinical progression-free survival at 5 years (5 years)
C: Conventional Radiotherapy (CIMRT) Versus Hypofractionated Radiotherapy (HIMRT) (8.5 years)
D: Overall Survival (From randomization to date of failure (death) or last follow-up. Analysis occurs after all patients have been potentially followed for 8 years.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Randomized Phase III Study of Adjuvant Oncophage® Versus Observation in Subjects With High Risk of Recurrence After Surgical Treatment for Renal Cell Carcinoma
Brief Summary: Determine whether patients receiving adjuvant HSPPC-96 treatment after surgically resected, locally advanced renal cell carcinoma have improved recurrence-free survival as compared to subjects with no adjuvant treatment.


Options:
A: Immune-related Progression Free Survival (irPFS) at 20 Weeks in MSI Positive and Negative Colorectal Adenocarcinoma Participants Using Immune Related Response Criteria (irRC) During Stages 1 and 2 (20 weeks); Immune-related Objective Response Rate in MSI Positive and Negative Colorectal Adenocarcinoma Participants Using Immune Related Response Criteria (irRC) During Stages 1 and 2 (28 months); Immune-related Progression Free Survival (irPFS) at 20 Weeks in MSI Positive Non-colorectal Adenocarcinoma Participants Using Immune Related Response Criteria (irRC) During Stages 1 and 2 (20 weeks); Objective Response Rate in MSI Positive Solid Tumor Malignancies Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (28 months); Progression Free Survival (PFS) at 20 Weeks in MSI Positive Solid Tumor Malignancies Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (20 weeks)
B: N/A
C: Clinical antitumor activity will be assessed as an objective tumor response as defined by RECIST. Tumor response is documented using standard definitions of CR and must be confirmed no less than 4 weeks after the criteria for response are first met. (24 weeks)
D: Progression-Free Survival (PFS), Core Radiology Assessment (Day 28 of each 6-week cycle: duration of treatment phase); Progression-Free Survival (PFS), Investigator's Assessment (Day 28 of each 6-week cycle: duration of treatment phase)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Open-Label, Comparative Study to Compare the Efficacy and Safety of Levofloxacin and Standard of Care Therapy in the Treatment of Children With Community-Acquired Pneumonia in the Hospitalized or Outpatient Setting
Brief Summary: The purpose of this study is to determine the safety and efficacy of levofloxacin in the treatment of children with community acquired pneumonia.


Options:
A: Primary outcome:; Clinical Cure: Respiratory rate below age specific cut-off (<50 bpm in infants <12 months and <40 bpm in 12 - 59 months of age).
B: length of stay at pediatric ward. (3 years)
C: The development of clinical treatment failure at day 6 among those children initially evaluated for ARI needing assessment (ANA) by a LHW at the domiciliary level. (At day 6)
D: Clinical cure rate (cured or not cured) at 10-17 days after the last dose of study medication.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy and Safety of Risperidone in Adolescents With Schizophrenia: a Comparison of Two Dose Ranges of Risperidone
Brief Summary: A clinical study to compare the safety and effectiveness of two different dose ranges of risperidone solution in the treatment of adolescents with a diagnosis of schizophrenia.


Options:
A: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at 8 Weeks (8 weeks); Change From Baseline in PANSS Positive Symptom Subscale Score at 8 Weeks. (8 weeks); Change From Baseline in PANSS Negative Symptom Subscale at Week 8 (8 weeks)
B: transition to subthreshold psychosis (and psychosis or schizophrenia)
C: Change in Weight (Baseline, 3-, 6-, 9-, 12-, and 18-months)
D: Change in total PANSS (Positive and Negative Syndrome Scale for Schizophrenia) from baseline to the 8-week endpoint

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy and Safety of Risperidone in Adolescents With Schizophrenia: a Comparison of Two Dose Ranges of Risperidone
Brief Summary: A clinical study to compare the safety and effectiveness of two different dose ranges of risperidone solution in the treatment of adolescents with a diagnosis of schizophrenia.


Options:
A: Change in Positive and Negative Syndrome Scale (PANSS) Total Score (Baseline and Day 42)
B: Assess the efficacy of a flexible dose of olanzapine compared to placebo in the treatment of adolescents (ages 13 - 17) with schizophrenia using the BPRS-C
C: Change in total PANSS (Positive and Negative Syndrome Scale for Schizophrenia) from baseline to the 8-week endpoint
D: Medication dose, Remission and response rate, exBPRSvs4, SANS, CGI - I, CGI - S, CDSS, GAF and QoL scale

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Randomized Pilot Study to Evaluate the Effects of Galantamine and Donepezil on Sleep and Attention and Gastrointestinal (GI) Tolerance in Patients With Mild to Moderate Alzheimer's Disease (AD)
Brief Summary: The purpose of this study is to evaluate the relative effects of galantamine compared to donepezil (both cholinesteraste inhibitors), on sleep, attention, and gastrointestinal tolerance in patients with Alzheimer's disease.


Options:
A: Sleep Efficiency (Post-intervention, up to 3 weeks); Sleep Minutes (post-intervention, up to 3 weeks)
B: To measure the differences between galantamine and donepazil for sleep and attention, explore methods of measuring sleep in patients with Alzheimer's Disease (AD)and their caregivers and attention in AD patients; GI tolerance
C: Change from Baseline in Nighttime Total Sleep Time (Baseline, 14 days follow-up)
D: Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog) (Quarterly over 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Safety and Efficacy Trial of LJP 394 in Systemic Lupus Erythematosus (SLE) Patients With a History of Renal Disease
Brief Summary: The purpose of this study is to determine whether LJP 394 (abetimus sodium) is safe and effective in delaying and reducing renal flares in patients with lupus nephritis.


Options:
A: Safety evaluation: Subject incidence of treatment-emergent adverse events, clinically significant changes in vital signs, physical examination endpoints, clinical laboratory safety tests, ECGs and the development of anti-AMG811 antibodies (197 days)
B: remission rate (month 6)
C: To assess the efficacy of FK506 combined with MMF versus intravenous CTX pulses in treatment of LN (18 months)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Study of Olanzapine Plus Fluoxetine in Combination for Treatment-Resistant Depression Without Psychotic Features
Brief Summary: The purposes of this study are to determine:

* Whether olanzapine plus fluoxetine in combination will help patients with treatment-resistant major depression.
* The safety of olanzapine plus fluoxetine in combination, plus and any side effects that might be associated with the combination.
* The effectiveness of olanzapine plus fluoxetine compared to olanzapine and fluoxetine alone.


Options:
A: Suicide completion and acts of deliberate self harm (DSH) will constitute the composite primary outcome (One year)
B: To assess the efficacy of up to 8 weeks of treatment with OFC versus olanzapine and fluoxetine monotherapies, in patients with recurrent MDD without psychotic features; who meet study criteria for TRD, as measured by last observation carried forward (LOCF) mean change from baseline to endpoint in the MADRS total score; Treatment-resistant depression will be defined as:historic failure to achieve satisfactory response to an antidepressant (other than fluoxetine) during the current MDD episode; when treated with an acceptable antidepressant drug and dose for at least 6 weeks; prospective failure to achieve a satisfactory response to fluoxetine monotherapy during the 8 week study lead-in phase
C: Mean Change From the End of Phase A (Week 8 Visit) to Phase B (Week 14 Visit) in the Montgomery-Asberg Depression Rating Scale for the Efficacy Sample Set (Baseline and Week 14); Mean Change in MADRS Total Score From Baseline End of Week 8 to Week 14 for the Efficacy Sample Per Final Protocol (Baseline and Week 14)
D: Mean Change in the Montgomery Åsberg Depression Rating Scale (MADRS) (Baseline (Week 8) and Week 14)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this clinical research study is to support earlier observations that Glucovance controls glucose levels after a mean, and improves overall glucose control better than metformin or glyburide therapy alone in adults with type 2 diabetes.


Options:
A: Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24 (Week 24)
B: Composite of cardiovascular events which were defined as death from a cardiovascular cause, death from any cause, nonfatal myocardial infarction, nonfatal stroke or arterial revascularization
C: N/A
D: ß-cell Response Measured by Hyperglycemic Clamp (3-months after medication washout (Month 15)); M/I (3-months after a medication washout)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Research Study in Patients With Persistent Macular Edema Due to Diabetic Retinopathy, Retinal Vein Occlusion, Uveitis, or Irvine-Gass Syndrome
Brief Summary: The purpose of this clinical research study is to evaluate the safety and effectiveness of an investigational medication to treat macular edema that persists despite current treatment methods. Participants will be evaluated for improvement in vision and side effects.

Macular edema is a condition that affects the back of the eye (retina). It frequently occurs in people who have a history of diabetes, and is also associated with high blood pressure, uveitis, and previous eye surgery. The main symptom of macular edema is decreased vision, generally a blurring of central vision.

There are no direct costs to participants for assessments and treatment as defined in the study protocol. All candidates must be available for required scheduled visits during the trial's 6-month follow-up period. Although the disease called age-related macular degeneration (AMD) affects the same region of the eye as macular edema, they are not the same condition and AMD is not studied in this research trial.


Options:
A: N/A
B: Change in Best-corrected Visual Acuity (Change in the Numbers of Letters Read From a Standard ETDRS Eye Chart) From Baseline to 24 Months in Eyes With Uveitis (24 months)
C: Recurrence of uveitis before and after implantation. (34 weeks pre-implantation; 34 weeks, 1 year, 2 years and 3 years post-implantation)
D: Time to first occurrence of uveitis in the study eye. (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Research Study in Patients With Persistent Macular Edema Due to Diabetic Retinopathy, Retinal Vein Occlusion, Uveitis, or Irvine-Gass Syndrome
Brief Summary: The purpose of this clinical research study is to evaluate the safety and effectiveness of an investigational medication to treat macular edema that persists despite current treatment methods. Participants will be evaluated for improvement in vision and side effects.

Macular edema is a condition that affects the back of the eye (retina). It frequently occurs in people who have a history of diabetes, and is also associated with high blood pressure, uveitis, and previous eye surgery. The main symptom of macular edema is decreased vision, generally a blurring of central vision.

There are no direct costs to participants for assessments and treatment as defined in the study protocol. All candidates must be available for required scheduled visits during the trial's 6-month follow-up period. Although the disease called age-related macular degeneration (AMD) affects the same region of the eye as macular edema, they are not the same condition and AMD is not studied in this research trial.


Options:
A: N/A
B: Visual acuity; Central macular thickness
C: visual acuity; central macular thickness
D: 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])

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Research Study in Patients With Persistent Macular Edema Due to Diabetic Retinopathy, Retinal Vein Occlusion, Uveitis, or Irvine-Gass Syndrome
Brief Summary: The purpose of this clinical research study is to evaluate the safety and effectiveness of an investigational medication to treat macular edema that persists despite current treatment methods. Participants will be evaluated for improvement in vision and side effects.

Macular edema is a condition that affects the back of the eye (retina). It frequently occurs in people who have a history of diabetes, and is also associated with high blood pressure, uveitis, and previous eye surgery. The main symptom of macular edema is decreased vision, generally a blurring of central vision.

There are no direct costs to participants for assessments and treatment as defined in the study protocol. All candidates must be available for required scheduled visits during the trial's 6-month follow-up period. Although the disease called age-related macular degeneration (AMD) affects the same region of the eye as macular edema, they are not the same condition and AMD is not studied in this research trial.


Options:
A: Mean Change in Best Corrected Visual Acuity (BCVA) at Month 6 (6 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: N/A
D: Best Corrected Visual Acuity (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Research Study in Patients With Persistent Macular Edema Due to Diabetic Retinopathy, Retinal Vein Occlusion, Uveitis, or Irvine-Gass Syndrome
Brief Summary: The purpose of this clinical research study is to evaluate the safety and effectiveness of an investigational medication to treat macular edema that persists despite current treatment methods. Participants will be evaluated for improvement in vision and side effects.

Macular edema is a condition that affects the back of the eye (retina). It frequently occurs in people who have a history of diabetes, and is also associated with high blood pressure, uveitis, and previous eye surgery. The main symptom of macular edema is decreased vision, generally a blurring of central vision.

There are no direct costs to participants for assessments and treatment as defined in the study protocol. All candidates must be available for required scheduled visits during the trial's 6-month follow-up period. Although the disease called age-related macular degeneration (AMD) affects the same region of the eye as macular edema, they are not the same condition and AMD is not studied in this research trial.


Options:
A: N/A
B: Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 14 Weeks (baseline to 14 weeks)
C: Percentage of Patients With a Best Corrected Visual Acuity (BCVA) Improvement of ≥15 Letters From Baseline in the Study Eye (Baseline, Month 39/Final Visit)
D: Change in Central Subfield Retinal Thickness From Baseline Over All Study Visits (Baseline to 3,6,9, and 12 weeks); Percentage of Participants With <250 Microns or ≥ 50% Reduction in Retinal Thickening From Baseline Over All Study Visits (Baseline to 3,6,9, and 12 Weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Research Study in Patients With Persistent Macular Edema Due to Diabetic Retinopathy, Retinal Vein Occlusion, Uveitis, or Irvine-Gass Syndrome
Brief Summary: The purpose of this clinical research study is to evaluate the safety and effectiveness of an investigational medication to treat macular edema that persists despite current treatment methods. Participants will be evaluated for improvement in vision and side effects.

Macular edema is a condition that affects the back of the eye (retina). It frequently occurs in people who have a history of diabetes, and is also associated with high blood pressure, uveitis, and previous eye surgery. The main symptom of macular edema is decreased vision, generally a blurring of central vision.

There are no direct costs to participants for assessments and treatment as defined in the study protocol. All candidates must be available for required scheduled visits during the trial's 6-month follow-up period. Although the disease called age-related macular degeneration (AMD) affects the same region of the eye as macular edema, they are not the same condition and AMD is not studied in this research trial.


Options:
A: N/A
B: Proportion of Subjects With Recurrence of Uveitis in the Study Eye and Overall Summary of Number of Participants With Ocular Treatment-Emergent Adverse Events for the Study Eye Through Month 36 Visit (36 months)
C: Recurrence of uveitis before and after implantation. (34 weeks pre-implantation; 34 weeks, 1 year, 2 years and 3 years post-implantation)
D: Time to first occurrence of uveitis in the study eye. (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Research Study in Patients With Persistent Macular Edema Due to Diabetic Retinopathy, Retinal Vein Occlusion, Uveitis, or Irvine-Gass Syndrome
Brief Summary: The purpose of this clinical research study is to evaluate the safety and effectiveness of an investigational medication to treat macular edema that persists despite current treatment methods. Participants will be evaluated for improvement in vision and side effects.

Macular edema is a condition that affects the back of the eye (retina). It frequently occurs in people who have a history of diabetes, and is also associated with high blood pressure, uveitis, and previous eye surgery. The main symptom of macular edema is decreased vision, generally a blurring of central vision.

There are no direct costs to participants for assessments and treatment as defined in the study protocol. All candidates must be available for required scheduled visits during the trial's 6-month follow-up period. Although the disease called age-related macular degeneration (AMD) affects the same region of the eye as macular edema, they are not the same condition and AMD is not studied in this research trial.


Options:
A: N/A
B: Time to first occurrence of uveitis in the study eye. (2 years)
C: Change in Best-corrected Visual Acuity (Change in the Numbers of Letters Read From a Standard ETDRS Eye Chart) From Baseline to 24 Months in Eyes With Uveitis (24 months)
D: Percentage of Patients With Vitreous Haze (Ocular Inflammation) Score of Zero (Week 8)

Answer: A