TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase III Trial of Paraplatin (Carboplatin) + Gemzar Versus Gemzar Alone in Patients With Advanced Non-Small Cell Lung Cancer
Brief Summary: To determine and compare the median survival produced by combined Gemcitabine plus Paraplatin versus Gemcitabine as a single-agent in patients with NSCLC and a PS equal to 2.


Options:
A: Progression-Free Survival (PFS) (Randomization to PD or death (up to 24 months))
B: To determine and compare the median survival produced by combined Gemcitabine plus Paraplatin versus Gemcitabine as a single-agent in patients with NSCLC and a PS equal to 2.
C: Overall survival (From date of randomization until the date of date of death from any cause, whichever came first, assessed up to 3 years maximum)
D: Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (Up to approximately 19 months); Overall Survival (OS) (Up to approximately 19 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Dose Response Study of Duloxetine Versus Placebo in the Treatment of Fibromyalgia Syndrome
Brief Summary: To assess the efficacy of Duloxetine compared with placebo in the treatment of pain in patients with Fibromyalgia syndrome, with or without major depressive disorder.


Options:
A: Mechanical and Heat Hyperalgesia (2 week intervals)
B: Change From Baseline to 12 Weeks in the Weekly Mean of the 24-Hour Average Pain Score on the 11-Point Numeric Rating Scale (NRS) (Baseline, Week 12)
C: Pressure Pain Threshold. (Difference between baseline (prior to treatment) compared with 10 weeks of 60 mg/daily duloxetine compared with placebo)
D: Assess efficacy of duloxetine versus placebo on the treatment of pain in patients with fibromyalgia syndrome

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Dose Response Study of Duloxetine Versus Placebo in the Treatment of Fibromyalgia Syndrome
Brief Summary: To assess the efficacy of Duloxetine compared with placebo in the treatment of pain in patients with Fibromyalgia syndrome, with or without major depressive disorder.


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: Assess efficacy of duloxetine versus placebo on the treatment of pain in patients with fibromyalgia syndrome
C: To assess the long-term safety of milnacipran used for the treatment of FMS at doses of 100 mg, 150 mg and 200 mg daily (12 months)
D: Change in Weekly Average Pain Intensity (Baseline and Week 21clinic visits)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Dose Response Study of Duloxetine Versus Placebo in the Treatment of Fibromyalgia Syndrome
Brief Summary: To assess the efficacy of Duloxetine compared with placebo in the treatment of pain in patients with Fibromyalgia syndrome, with or without major depressive disorder.


Options:
A: Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Pregabalin Compared With Duloxetine (baseline, 12 weeks)
B: Change From Week 8 to Week 16 Endpoint in 24 Hour Average Pain Item Score on the Brief Pain Inventory (BPI) Modified Short Form (Week 8, Week 16)
C: Assess efficacy of duloxetine versus placebo on the treatment of pain in patients with fibromyalgia syndrome
D: Whether there is a reduction in subjective pain as assessed by the Brief Pain Inventory. (December 2008)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Dose Response Study of Duloxetine Versus Placebo in the Treatment of Fibromyalgia Syndrome
Brief Summary: To assess the efficacy of Duloxetine compared with placebo in the treatment of pain in patients with Fibromyalgia syndrome, with or without major depressive disorder.


Options:
A: Week 12 Brief Pain Inventory (BPI) Worst Pain/Stiffness Score (12 weeks post-registration)
B: Assess efficacy of duloxetine versus placebo on the treatment of pain in patients with fibromyalgia syndrome
C: Assessment of arthralgia scores and patients' compliance within the first year of anastrozole treatment, stratified by upfront and switch therapy as well as assessment of the relationship between compliance and arthralgia scores. (12 months)
D: Disease free survival. (Up to end of year 2015)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind Comparison of LY686017, Paroxetine, and Placebo in the Treatment of Social Anxiety Disorder
Brief Summary: This study is a Phase 2 trial to test the efficacy of LY686017 in the treatment of Social Anxiety Disorder.


Options:
A: Change in Liebowitz Social Anxiety Scale (LSAS) - total score (Change from Baseline to Final Study Visit: minimum 1 week - maximum 12 weeks)
B: Superiority is defined as a statistically greater reduction of the mean change from baseline to endpoint (after 12 weeks of treatment) in the Liebowitz Social Anxiety Scale (LSAS) total score.
C: Subjective Unit of Discomfort Scale (Once before and again 10 minutes after intranasal dosing with PH94B spray, during exposure to a public speaking challenge)
D: Personal Report of Confidence as a Speaker (PRCS)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Multicenter Study of Immediate Postoperative Instillation of Gemcitabine in Patients With Superficial Transitional Cell Carcinoma of the Bladder
Brief Summary: A randomized, double-blind, placebo-controlled Phase 3 multicenter study to assess the efficacy and safety of intravesical instillation of gemcitabine versus placebo immediately after transurethral resection of the bladder tumor.


Options:
A: Proportion of Patients With Histologically Confirmed Malignancy Where Malignancy is Only Detected With Blue Light Cystoscopy With Cysview and Not White Light Cystoscopy (At time of cystoscopy procedure)
B: Proportion of Patients With Histologically Confirmed Recurrence Within One 1 Year. (1 year)
C: Number of Participants Without Grade ≥ 3 Adverse Event, Graded According to NCI CTCAE Version 4.03 (Two years)
D: Recurrence-Free Survival (RFS) (Surgery to recurrence or death (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimization of Growth Hormone Treatment in Short Children Born Small for Gestational Age Based on a Growth Prediction Model-The OPTIMA Trial
Brief Summary: Comparison of 2 different doses of human growth hormone treatment on change in height after 1 and 2 years of treatment.


Options:
A: Number of mature follicles in the study and control group.
B: Proportion of older ED patients who receive a potentially inappropriate medication (During discharge home from the ED)
C: rate of patients with therapeutic INR levels on day six without anticoagulation-related complications during the loading period (after 30 days)
D: The 2 different doses used are non-inferior to each other

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase III Trial of Gemzar Versus Doxil With Crossover Treatment Option for Patients With Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer Undergoing Second or Third-Line Chemotherapy
Brief Summary: This trial compares two chemotherapy agents for the treatment of recurrent ovarian, fallopian or primary peritoneal cancer in patients that have received and are no longer responding to Platinum based treatment. The purpose of this trial is to compare progression free survival between gemcitabine and liposomal doxorubicin. Progression free survival (PFS) is defined as the period from study entry until disease progression


Options:
A: Adverse events, clinically significant changes in laboratory results, ECG, and vital signs, to be measured throughout the study.; Pharmacokinetic Profile of AMG 386 - blood levels of AMG 386 to be measured throughout the study.
B: - Progression free survival (PFS) in patients who have failed one, but no more than two, prior treatments
C: Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1) (Radiologic scans performed at baseline then every 12 weeks up to 156 weeks, then every 24 weeks thereafter until objective radiological disease progression. DCO: 17 May 2018)
D: Progression free survival (up to 18 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Ten-Week, Randomized, Double-Blind Study Evaluating the Efficacy of Duloxetine 60mg Once Daily Versus Placebo in Outpatients With Major Depressive Disorder and Pain
Brief Summary: To determine the efficacy of Duloxetine vs. placebo on pain as determined by change in the Brief Pain Inventory (BPI) from baseline over 8 weeks of treatment


Options:
A: 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)
B: Assess efficacy of duloxetine versus placebo on the treatment of pain in patients with fibromyalgia syndrome
C: Compare efficacy of Duloxetine versus placebo on somatic complaints of pain in patients meeting criteria for major depressive disorder.
D: 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)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Switching to Duloxetine From Other Antidepressants: A Regional Multicentre Trial Comparing Two Switching Techniques
Brief Summary: A multicentre, randomised, open label study of out-patients with major depression who have failed to respond adequately to antidepressant treatment for their current episode of depression. The study compares outcomes associated with two methods of switching from current antidepressant to duloxetine


Options:
A: Change From Baseline in MADRS Total Score at Week 8 (Baseline and Week 8)
B: 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)
C: To test the hypothesis that the efficacy associated with direct switch from SSRI to duloxetine is non-inferior to start-taper switch
D: MADRS score (weeks 0 (randomization); 8, 9, 10, 12, 14, 16, 18, and 20)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase II Study Comparing Single Agent Gemcitabine Intravesical Therapy Versus Mitomycin C in Patients With Intermediate Risk Superficial Bladder Cancer
Brief Summary: Gemcitabine has been shown to be highly effective and well tolerated in the first and second line therapy, as a single agent or in combination therapy for treatment of metastatic transitional cell carcinoma. On the basis of Gemcitabine clinical activity and good tolerability this drug has been recently tested in intravesical therapy. we consider Gemcitabine as a good therapy candidate for patient with intermediate risk superficial bladder cancer. Based on the phase I/II clinical trials w are going to explore the efficacy and tolerability of Gemcitabine in this setting, and compare it to Mitomycin C which is widely used in this group of patients.


Options:
A: Compare the tumor recurrence rate at 12 months after TUR in patients with intermediate risk superficial bladder cancer treated with intravesical Gemcitabine or Mitomycin C.
B: Recurrence-Free Survival (RFS) (Up to 4 years)
C: Proportion of Patients With Histologically Confirmed Malignancy Where Malignancy is Only Detected With Blue Light Cystoscopy With Cysview and Not White Light Cystoscopy (At time of cystoscopy procedure)
D: Recurrence-Free Survival (RFS) (Surgery to recurrence or death (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IV Study to Evaluate the Effectiveness of Flumist (Influenza Vaccine, Live Intranasal) Vaccination in a School-Based Intervention Program
Brief Summary: To measure the effectiveness of influenza vaccination in school children by comparing, between target(i.e., children are offered FluMist) and control (i.e., children are not offered FluMist) school families.


Options:
A: Number of Participants With Fever Post Dose 1 (Days 1-8), Defined as an Oral Temperature ≥ 101°F (38.3°C). (Days 1-8); Number of Participants Who Experienced a Post Dose 1 (Day 15) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus (Day 1, Day 15); Number of Participants Who Experienced a Post Dose 1 (Day 29) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus (Day 1, Day 29); Number of Participants Who Experienced a Post Dose 2 (Day 57) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus (Day 1, Day 57)
B: The primary endpoint for efficacy is the first episode in the first season in a study child of a culture-confirmed influenza illness, caused by community-acquired subtypes antigenically similar to those contained in the vaccine.
C: To compare the families of children in the target schools with families of children in the control schools with respect to workdays lost by adults and school days lost by children. (7 days after each vaccination)
D: Number of Participants With Fever Post Dose 1 (Days 1-8), Defined as an Axillary Temperature ≥ 101°F (38.3°C). (Days 1- 8); Number of Participants Who Experience a Post Dose 1 (Day 15) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus (Day 1, Day 15); Number of Participants Who Experience a Post Dose 1 (Day 29) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus (Day 1, Day 29); Number of Participants Who Experience a Post Dose 2 (Day 57) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus (Day 1, Day 57)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IV Study to Evaluate the Effectiveness of Flumist (Influenza Vaccine, Live Intranasal) Vaccination in a School-Based Intervention Program
Brief Summary: To measure the effectiveness of influenza vaccination in school children by comparing, between target(i.e., children are offered FluMist) and control (i.e., children are not offered FluMist) school families.


Options:
A: The 4 Post-dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) in the Q/LAIV (MEDI3250) Arm Are Noninferior to Those in the Comparator FluMist Group. (Day 28-35)
B: To compare the families of children in the target schools with families of children in the control schools with respect to workdays lost by adults and school days lost by children. (7 days after each vaccination)
C: Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months (Pre-vaccination (Day 0) and 21 days post-vaccination); Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months (Pre-vaccination (Day 0) and Day 21 post-vaccination); Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months (Pre-vaccination (Day 0) and 21 days post-vaccination); Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years (Pre-vaccination (Day 0) and 21 days post-vaccination); Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years (Pre-vaccination (Day 0) and Day 21 post-vaccination); Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years (Pre-vaccination (Day 0) and Day 21 post-vaccination); Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months (Days 0 to 7 post-vaccination); Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months (Days 0 to 7 post-vaccination); Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years (Days 0 to 7 post vaccination)
D: Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Vaccine-matched Strains). (Through 7 to 9 months post-vaccination)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial to Compare the Safety, Tolerability, Immunogenicity and Efficacy of One Dose and Two Doses of a Liquid Formulation of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) Compared With Placebo in Healthy Children
Brief Summary: The purpose of this study is to determine the efficacy of the liquid formulation of CAIV-T against culture confirmed influenza illness in healthy children aged at least 6 months and less than 36 months.


Options:
A: To compare the families of children in the target schools with families of children in the control schools with respect to workdays lost by adults and school days lost by children. (7 days after each vaccination)
B: Number of Participants With Fever Post Dose 1 (Days 1-8), Defined as an Oral Temperature ≥ 101°F (38.3°C). (Days 1-8); Number of Participants Who Experienced a Post Dose 1 (Day 15) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus (Day 1, Day 15); Number of Participants Who Experienced a Post Dose 1 (Day 29) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus (Day 1, Day 29); Number of Participants Who Experienced a Post Dose 2 (Day 57) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus (Day 1, Day 57)
C: Number of Participants With Fever Post Dose 1 (Days 1-8), Defined as an Axillary Temperature ≥ 101°F (38.3°C). (Days 1- 8); Number of Participants Who Experience a Post Dose 1 (Day 15) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus (Day 1, Day 15); Number of Participants Who Experience a Post Dose 1 (Day 29) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus (Day 1, Day 29); Number of Participants Who Experience a Post Dose 2 (Day 57) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus (Day 1, Day 57)
D: The primary endpoint for efficacy is the first episode in the first season in a study child of a culture-confirmed influenza illness, caused by community-acquired subtypes antigenically similar to those contained in the vaccine.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial to Compare the Safety, Tolerability, Immunogenicity and Efficacy of One Dose and Two Doses of a Liquid Formulation of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) Compared With Placebo in Healthy Children
Brief Summary: The purpose of this study is to determine the efficacy of the liquid formulation of CAIV-T against culture confirmed influenza illness in healthy children aged at least 6 months and less than 36 months.


Options:
A: The 4 Post-dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) in the Q/LAIV (MEDI3250) Arm Are Noninferior to Those in the Comparator FluMist Group. (Day 28-35)
B: Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months (Pre-vaccination (Day 0) and 21 days post-vaccination); Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months (Pre-vaccination (Day 0) and Day 21 post-vaccination); Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months (Pre-vaccination (Day 0) and 21 days post-vaccination); Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years (Pre-vaccination (Day 0) and 21 days post-vaccination); Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years (Pre-vaccination (Day 0) and Day 21 post-vaccination); Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years (Pre-vaccination (Day 0) and Day 21 post-vaccination); Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months (Days 0 to 7 post-vaccination); Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months (Days 0 to 7 post-vaccination); Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years (Days 0 to 7 post vaccination)
C: The primary endpoint for efficacy is the first episode in the first season in a study child of a culture-confirmed influenza illness, caused by community-acquired subtypes antigenically similar to those contained in the vaccine.
D: Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Vaccine-matched Strains). (Through 7 to 9 months post-vaccination)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial to Compare the Safety, Tolerability, Immunogenicity and Efficacy of One Dose and Two Doses of a Liquid Formulation of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) Compared With Placebo in Healthy Children
Brief Summary: The purpose of this study is to determine the efficacy of the liquid formulation of CAIV-T against culture confirmed influenza illness in healthy children aged at least 6 months and less than 36 months.


Options:
A: Number of Subjects (Unprimed) 6 to <36 Months Age With Local and Systemic Reactions After Any Vaccination for All Seasons, Comparison of Adjuvanted Trivalent Influenza Vaccine (aTIV) and Flu Vaccine Control. (7 days post-vaccination); Percentage of Subjects (Unprimed) Aged 6 to <36 Months With Virus-Confirmed Influenza, Comparison of aTIV and Non-flu Vaccine Control (Men C/TBE Vaccine) (3 weeks after 2nd vaccination)
B: The primary endpoint for efficacy is the first episode in the first season in a study child of a culture-confirmed influenza illness, caused by community-acquired subtypes antigenically similar to those contained in the vaccine.
C: Laboratory-confirmed influenza infection. (up to 3 years)
D: Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain. (At Day 42.)

Answer: B