TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Multicenter, Phase 2 Study to Compare the Efficacy of Panitumumab in Combination With mFOLFOX6 to the Efficacy of Bevacizumab in Combination With mFOLFOX6 in Patients With Previously Untreated, KRAS Wild-Type, Unresectable, Metastatic Colorectal Cancer
Brief Summary: The primary objective of this study is to estimate the treatment effect on progression-free survival (PFS) of panitumumab relative to bevacizumab in combination with mFOLFOX6 chemotherapy as first-line therapy in patients with tumors expressing wild-type KRAS, unresectable mCRC.


Options:
A: Progression-free Survival (PFS) (From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.)
B: Progression-free Survival (PFS) (From randomization until the data cut-off date of 8 April 2008. Maximum follow-up time was 17 months.); Overall Survival (From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months)
C: Overall survival
D: progression-free survival (3 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Study of Standard Fractionation Radiotherapy With Concurrent High-Dose Cisplatin Versus Accelerated Fractionation Radiotherapy With Panitumumab in Patients With Locally Advanced Stage III and IV Squamous Cell Carcinoma of the Head and Neck
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in higher doses over a shorter period of time may kill more tumor cells and have fewer side effects. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving standard radiation therapy together with high-dose cisplatin is more effective than giving higher-dose radiation therapy together with panitumumab in treating patients with locally advanced head and neck cancer.

PURPOSE: This randomized phase III trial is comparing two radiation therapy regimens to see how well they work when given together with cisplatin or panitumumab in treating patients with locally advanced stage III or stage IV head and neck cancer.


Options:
A: Efficacy (18 weeks)
B: Progression-free Survival (PFS) Rate (6.2 years)
C: Overall survival (5 years)
D: Progression free survival (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 74 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: KIDNET vs Meditation/Relaxation - a Dissemination Randomized Controlled Treatment Trial for Children in Sri Lanka Traumatized by the War and the Tsunami
Brief Summary: The purpose of this study is to assess the efficacy of KIDNET versus a Meditation/Relaxation protocol in treating traumatized children in Sri Lanka when applied by locally trained teacher counsellors.


Options:
A: depression (pre, post and 6 months post treatment)
B: Change in adolescent mental health symptoms (baseline, 4 month followup, and 12 month followup); Change in parent mental health symptoms (baseline, 4 month followup, 12 month followup); Change in parent-child conflict (baseline, 4 month followup, 12 month followup); Change in parent-child relationship quality (baseline, 4 month followup, 12 month followup)
C: Change in scores on the Oxford Measure of Psychosocial Adjustment & World Health Organization Disability Assessment Schedule, 2.0 (WHODAS 2.0) (Administered at 4 timepoints: (1) baseline; (2) within 15 days of YRI completion; (3) 6 months post-YRI; (4) 12 months post-YRI)
D: PTSD Symptom Severity according to UPID; DSM IV Diagnosis of Posttraumatic Stress disorder (pre-treatment, 1 month post, 6 months follow up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a Web-Assisted Quitline for Smokeless Tobacco Users
Brief Summary: The purpose of this record is to test whether (a) participants who receive a Web-based smokeless tobacco cessation intervention will be more likely to be abstinent than participants who do not receive this intervention, and (b) whether participants who receive a telephone quitline intervention will be more likely to be abstinent than participants who are not in a quitline intervention.


Options:
A: Prolonged abstinence from all tobacco (3 months and 6 months)
B: Long-term Smoking Abstinence (30-day Point Prevalence Abstinence) (6 months after enrollment)
C: Change in Weight (Baseline, 3 months, 6 months, 9 months, 12 months and 1 year post program follow up); Change in the 6 minute walk test (Baseline, 3 months, 6 monhts, 9 months, 12 months, and 1 year post program completion follow up); Change in Days of Abstinence-Timeline follow back interview for tobacco smokers (Baseline, 3 months, 6 months, 9 months, 12 months, and 1 year post program completion follow up); Change in Carbon Monoxide Level (Baseline, 3 months, 6 months, 9 months, 12 months, and 1 year post program completion follow up)
D: Number of Participants With Prolonged Abstinence Through 6 Months Verified by Carbon Monoxide Measurement (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a Web-Assisted Quitline for Smokeless Tobacco Users
Brief Summary: The purpose of this record is to test whether (a) participants who receive a Web-based smokeless tobacco cessation intervention will be more likely to be abstinent than participants who do not receive this intervention, and (b) whether participants who receive a telephone quitline intervention will be more likely to be abstinent than participants who are not in a quitline intervention.


Options:
A: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
B: Prolonged abstinence from all tobacco (3 months and 6 months)
C: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12
D: Number of Subjects With a 4 Week Continuous Quit Rate (CQR) From Smokeless Tobacco (Weeks 9 through 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Controlled Trial of Rectal Indomethacin in the Prevention of Post-ERCP Pancreatitis in High Risk Patients.
Brief Summary: Pancreatitis (inflammation of the pancreas) is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP), a procedure for the diagnosis and treatment of disorders of the pancreas and bile duct.

Preliminary data has shown that non-steroidal antiinflammatory drugs, when administered rectally, can reduce the risk of pancreatitis after ERCP. This study is intended to definitively determine whether rectally administered indomethacin (a non-steroidal antiinflammatory drug)is effective at preventing pancreatitis after ERCP.


Options:
A: The primary safety endpoint was the number of bleedings, and the primary efficacy endpoint was the change in SOFA between the start of the drug (day 0) and day 5. (0-60 days)
B: Change in C-Reactive Protein (CRP) (baseline, Day 1, Day 3); Change in Tumor Necrosis Factor (TNF)-Alpha (baseline, Day 1, Day 3); Change in Interleukin (IL) IL-6 (baseline, Day 1, Day 3); Changes in Interleukin (IL) IL-8 (baseline, Day 1, Day 3)
C: Reduction of the CRP by 20% from the control group (Day 7 post infusion)
D: Post-ERCP Pancreatitis (5 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Controlled Trial of Rectal Indomethacin in the Prevention of Post-ERCP Pancreatitis in High Risk Patients.
Brief Summary: Pancreatitis (inflammation of the pancreas) is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP), a procedure for the diagnosis and treatment of disorders of the pancreas and bile duct.

Preliminary data has shown that non-steroidal antiinflammatory drugs, when administered rectally, can reduce the risk of pancreatitis after ERCP. This study is intended to definitively determine whether rectally administered indomethacin (a non-steroidal antiinflammatory drug)is effective at preventing pancreatitis after ERCP.


Options:
A: Post-ERCP pancreatitis (30 days after ERCP)
B: post ERCP pancreatitis rate (up to 4 weeks)
C: The Number of Participants With Acute Pancreatitis After ERCP as Assessed by Worsening Abdominal Pain Plus Either Elevated Amylase or Lipase 3 x Upper Limit of Normal (30 days after ERCP); The Number of Participants With Acute Pancreatitis After ERCP as Assessed by Worsening Abdominal Pain Plus Imaging Suggestive of Acute Pancreatitis (30 days after ERCP)
D: Post-ERCP Pancreatitis (5 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Endoscopic Sclerotherapy and/or Ligation Versus Portacaval Shunt for Bleeding
Brief Summary: In unselected cirrhotic patients with bleeding gastric varices to compare the influence on mortality rate, duration of life, control of bleeding, quality of life, and economic costs of treatment of: portacaval shunt, endoscopic variceal sclerotherapy and/or variceal ligation.


Options:
A: Number of patients with controlled bleeding (6 months)
B: Treatment failure (5 days)
C: Combined: bleeding + absence of severe adverse events + survival (15 days)
D: Survival (10 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Endoscopic Sclerotherapy and/or Ligation Versus Portacaval Shunt for Bleeding
Brief Summary: In unselected cirrhotic patients with bleeding gastric varices to compare the influence on mortality rate, duration of life, control of bleeding, quality of life, and economic costs of treatment of: portacaval shunt, endoscopic variceal sclerotherapy and/or variceal ligation.


Options:
A: Number of survival without liver transplantation (2 years)
B: Survival (10 years)
C: Number of participants with variceal rebleeding (4 years)
D: Survival (One Year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Protein Levels and Caloric Density on the Growth of Formula Fed Infants From Overweight or Obese Mothers
Brief Summary: The purpose of this study is to determine whether infants, from overweight or obese mothers, fed a formula with proteins and calories different than a standard infant formula have a different growth


Options:
A: Body mass index BMI: derived from measured body height (m) and body weight (kg) as body weight / height² (At age 11 years and 18 years)
B: BMI-for-age z-score (Age 24 months)
C: mean weight gain (3 months)
D: Weight gain (1- 365 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Agitation in the Nursing Home
Brief Summary: The purpose of this study is to examine the efficacy of non-pharmacological ways to treat agitated behaviors in nursing home residents with dementia. The hypothesis is that non-pharmacological interventions will be more effective than placebo in decreasing such behaviors.


Options:
A: Agitation Behavior Mapping Instrument (ABMI) (10 days of intervention vs. 10 days of baseline)
B: N/A
C: Antipsychotic Efficacy (Day 43)
D: Antipsychotic dispensing (6 months post-intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Agitation in the Nursing Home
Brief Summary: The purpose of this study is to examine the efficacy of non-pharmacological ways to treat agitated behaviors in nursing home residents with dementia. The hypothesis is that non-pharmacological interventions will be more effective than placebo in decreasing such behaviors.


Options:
A: Change in the Cornell Scale for Depression in Dementia (CSDD) (Week -2, week 0, week 6 and week 13)
B: Cohen-Mansfield Agitation Inventory - long form (CMAI) (CMAI will be used during the screening/inclusion process, at week 2, 4, 8, and 12.)
C: Change from Baseline in Pain at 3 months (3 months); Change from Baseline in Pain at 6 months (6 months post intervention)
D: Agitation Behavior Mapping Instrument (ABMI) (10 days of intervention vs. 10 days of baseline)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Agitation in the Nursing Home
Brief Summary: The purpose of this study is to examine the efficacy of non-pharmacological ways to treat agitated behaviors in nursing home residents with dementia. The hypothesis is that non-pharmacological interventions will be more effective than placebo in decreasing such behaviors.


Options:
A: Agitation (During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period); Passivity (During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period)
B: Composite: Proportion of patients with any risk factor as defined in secondary outcome measures to 9, who have received any high risk prescriptions of anti-inflammatory drugs or antiplatelets as defined in secondary outcome measures 1 to 9 (8 weeks)
C: Engagement between the 1st minute - 10th minute of each session (through study completion for 8 weeks); Engagement between the 25th minute - 35th minute of each session (through study completion for 8 weeks); Engagement between the 50th minute - 60th minute of each session (through study completion for 8 weeks); Affect between the 1st minute - 10th minute of each session (through study completion for 8 weeks); Affect between the 25th minute - 35th minute of each session (through study completion for 8 weeks); Affect between the 50th minute - 60th minute of each session (through study completion for 8 weeks)
D: Agitation Behavior Mapping Instrument (ABMI) (10 days of intervention vs. 10 days of baseline)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Agitation in the Nursing Home
Brief Summary: The purpose of this study is to examine the efficacy of non-pharmacological ways to treat agitated behaviors in nursing home residents with dementia. The hypothesis is that non-pharmacological interventions will be more effective than placebo in decreasing such behaviors.


Options:
A: Agitation Behavior Mapping Instrument (ABMI) (10 days of intervention vs. 10 days of baseline)
B: Agitation (During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period); Passivity (During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period)
C: Composite: Proportion of patients with any risk factor as defined in secondary outcome measures to 9, who have received any high risk prescriptions of anti-inflammatory drugs or antiplatelets as defined in secondary outcome measures 1 to 9 (8 weeks)
D: Neuropsychiatric Inventory (At baseline in the 2 weeks prior to the music therapy intervention, then at weeks 11-12, weeks 21-22 and as a follow-up at week 27-28.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Vehicle-Controlled, Rising Dose, Safety, Tolerability, Pharmacokinetic and Preliminary Efficacy Study of Ruxolitinib Phosphate Cream When Applied to Patients With Plaque Psoriasis
Brief Summary: The study is comprised of two parts. The first portion of this study will be a double-blind, Sponsor-unblinded, vehicle-controlled study with application of ruxolitinib or vehicle to paired lesions at least 15 cm apart in patients with active but stable plaque psoriasis. Part 2 of the study is a double-blind, sponsor unblinded, comparison of ruxolitinib with two FDA approved products in patients with active but stable plaque psoriasis.


Options:
A: Percentage of Participants With Static Physician Global Assessment (sPGA) of 0 or 1 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA) (Week 12); Percentage of Participants Achieving ≥75% Improvement in Ps Area and Severity Index (PASI75) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: PASI) (Week 12)
B: Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline (Baseline, Days 8, 15, 22, 28 and 56); Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline (Baseline, Days 8, 15, 22, 28 and 56); Number of Participants With Treatment Emergent Adverse Events (3 months); Pharmacokinetics Parameter : Skin Flux of INCB018424 (Days 8, 15, 22, and 28); Pharmacokinetics Parameter : Bioavailability of INCB018424 (Days 8, 15, 22, and 28)
C: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16 (Week 16); Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 90 Response at Week 16 (Week 16)
D: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A) (Week 16); Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A) (Week 16)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Vehicle-Controlled, Rising Dose, Safety, Tolerability, Pharmacokinetic and Preliminary Efficacy Study of Ruxolitinib Phosphate Cream When Applied to Patients With Plaque Psoriasis
Brief Summary: The study is comprised of two parts. The first portion of this study will be a double-blind, Sponsor-unblinded, vehicle-controlled study with application of ruxolitinib or vehicle to paired lesions at least 15 cm apart in patients with active but stable plaque psoriasis. Part 2 of the study is a double-blind, sponsor unblinded, comparison of ruxolitinib with two FDA approved products in patients with active but stable plaque psoriasis.


Options:
A: Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline (Baseline, Days 8, 15, 22, 28 and 56); Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline (Baseline, Days 8, 15, 22, 28 and 56); Number of Participants With Treatment Emergent Adverse Events (3 months); Pharmacokinetics Parameter : Skin Flux of INCB018424 (Days 8, 15, 22, and 28); Pharmacokinetics Parameter : Bioavailability of INCB018424 (Days 8, 15, 22, and 28)
B: Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 (12 weeks); Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 (12 weeks); Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12 (12 Weeks)
C: Number of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA) (Week 12); Number of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI) (Week 12)
D: Proportion of patients with at least 75% improvement in PASI from baseline (PASI75) at Week 16. (Baseline to week 16)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Vehicle-Controlled, Rising Dose, Safety, Tolerability, Pharmacokinetic and Preliminary Efficacy Study of Ruxolitinib Phosphate Cream When Applied to Patients With Plaque Psoriasis
Brief Summary: The study is comprised of two parts. The first portion of this study will be a double-blind, Sponsor-unblinded, vehicle-controlled study with application of ruxolitinib or vehicle to paired lesions at least 15 cm apart in patients with active but stable plaque psoriasis. Part 2 of the study is a double-blind, sponsor unblinded, comparison of ruxolitinib with two FDA approved products in patients with active but stable plaque psoriasis.


Options:
A: Mean Percentage Change From Baseline in the Product of BSA (%) and the sPGA Which is Considered as the Total Psoriasis Severity Index at Week 16 (Baseline to Week 16 (end of phase))
B: Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline (Baseline, Days 8, 15, 22, 28 and 56); Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline (Baseline, Days 8, 15, 22, 28 and 56); Number of Participants With Treatment Emergent Adverse Events (3 months); Pharmacokinetics Parameter : Skin Flux of INCB018424 (Days 8, 15, 22, and 28); Pharmacokinetics Parameter : Bioavailability of INCB018424 (Days 8, 15, 22, and 28)
C: Number of Patients Achieving "Clear" or "Almost Clear" on Physician Global Assessment (PGA) of Psoriasis (12 weeks)
D: Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (Week 12); Percentage of PASI Improvement From Baseline to 12 Week Endpoint (Baseline to Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Vehicle-Controlled, Rising Dose, Safety, Tolerability, Pharmacokinetic and Preliminary Efficacy Study of Ruxolitinib Phosphate Cream When Applied to Patients With Plaque Psoriasis
Brief Summary: The study is comprised of two parts. The first portion of this study will be a double-blind, Sponsor-unblinded, vehicle-controlled study with application of ruxolitinib or vehicle to paired lesions at least 15 cm apart in patients with active but stable plaque psoriasis. Part 2 of the study is a double-blind, sponsor unblinded, comparison of ruxolitinib with two FDA approved products in patients with active but stable plaque psoriasis.


Options:
A: Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline (Baseline, Days 8, 15, 22, 28 and 56); Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline (Baseline, Days 8, 15, 22, 28 and 56); Number of Participants With Treatment Emergent Adverse Events (3 months); Pharmacokinetics Parameter : Skin Flux of INCB018424 (Days 8, 15, 22, and 28); Pharmacokinetics Parameter : Bioavailability of INCB018424 (Days 8, 15, 22, and 28)
B: Number of Patients Achieving "Clear" or "Almost Clear" on Physician Global Assessment (PGA) of Psoriasis (12 weeks)
C: Change in PASI score from baseline in the two groups (12 weeks)
D: Percentage of Participants With a Psoriasis Area and Severity Index (PASI)75 Response at Week 16 (Week 16); Number of Participants Experiencing Adverse Events (Up to 72 weeks); Number of Particpants Discontinuing Study Treatment Due to Adverse Events (Up to 52 weeks)

Answer: A