TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Temozolomide Plus Bevacizumab Chemotherapy in Supratentorial Glioblastoma in 70 Years and Older Patients With an Impaired Functional Status (KPS<70)
Brief Summary: The optimal treatment of glioblastoma multiforme (GBM) in patients aged ≥70 years with a Karnofsky performance status (KPS) \<70 is unestablished. This clinical trial evaluated the efficacy and safety of upfront temozolomide (TMZ) and bevacizumab (Bev) in patients aged ≥70 years and a KPS \<70.


Options:
A: Survival (assessed every 6 weeks for 42 weeks, then every 4 months for one year, followed by every 6 months for years 2 through 5)
B: Median Overall Survival (OS) (OS calculated from the date of surgery until death or up to 36 months.)
C: Progression Free Survival (PFS) time (5 years)
D: Survival

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, 52-week, Placebo Controlled Efficacy and Safety Study of Dupilumab, in Patients With Bilateral Nasal Polyposis on a Background Therapy With Intranasal Corticosteroids
Brief Summary: Primary Objective:

To evaluate the efficacy of dupilumab 300 mg every 2 weeks (q2w) compared to placebo on a background of mometasone furoate nasal spray (MFNS) in reducing nasal congestion (NC)/obstruction severity and endoscopic nasal polyp score (NPS) in participants with bilateral nasal polyps (NP). In addition for Japanese participants, reduction in computed tomography (CT) scan opacification of the sinuses was a co-primary objective.

Secondary Objectives:

* To evaluate the efficacy of dupilumab in improving total symptoms score.
* To evaluate the efficacy of dupilumab in improving sense of smell.
* To evaluate the efficacy of dupilumab in reducing CT scan opacification of the sinuses (primary objective for Japanese participants).
* To evaluate ability of dupilumab in reducing proportion of participants who required treatment with systemic corticosteroids (SCS) or surgery for NP.
* To evaluate the effect of dupilumab on participant reported outcomes and health related quality of life.
* To evaluate the efficacy of dupilumab 300 mg q2w up to Week 52.
* To evaluate the efficacy of dupilumab 300 mg q2w up to Week 24 followed by 300 mg every 4 weeks (q4w) up to Week 52.
* To evaluate the effect of dupilumab in the subgroups of participants with prior surgery and comorbid asthma including non-steroid anti-inflammatory drug exacerbated respiratory disease.
* To evaluate the safety of dupilumab in participants with bilateral NP.
* To evaluate functional dupilumab concentrations (systemic exposure) and incidence of treatment emergent anti-drug antibodies.


Options:
A: Change in Nasal Polyp Score (Week 5 and Week 25)
B: Change From Baseline at Week 24 in Nasal Congestion/Obstruction Symptom Severity Score (Baseline, Week 24); Change From Baseline at Week 24 in Nasal Polyp Score (Baseline, Week 24)
C: Change From Baseline at Week 24 in Nasal Congestion/Obstruction Symptom Severity Score (Baseline, Week 24); Change From Baseline at Week 24 in Nasal Polyp Score (Baseline, Week 24)
D: Frequency of Clinical Asthma Exacerbations (CAEs) During 12 Months of Treatment (Day 1 to Week 52); Frequency of Each of the Two Criteria for Clinical Asthma Exacerbations (CAEs) (Day 1 to Week 52)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, 52-week, Placebo Controlled Efficacy and Safety Study of Dupilumab, in Patients With Bilateral Nasal Polyposis on a Background Therapy With Intranasal Corticosteroids
Brief Summary: Primary Objective:

To evaluate the efficacy of dupilumab 300 mg every 2 weeks (q2w) compared to placebo on a background of mometasone furoate nasal spray (MFNS) in reducing nasal congestion (NC)/obstruction severity and endoscopic nasal polyp score (NPS) in participants with bilateral nasal polyps (NP). In addition for Japanese participants, reduction in computed tomography (CT) scan opacification of the sinuses was a co-primary objective.

Secondary Objectives:

* To evaluate the efficacy of dupilumab in improving total symptoms score.
* To evaluate the efficacy of dupilumab in improving sense of smell.
* To evaluate the efficacy of dupilumab in reducing CT scan opacification of the sinuses (primary objective for Japanese participants).
* To evaluate ability of dupilumab in reducing proportion of participants who required treatment with systemic corticosteroids (SCS) or surgery for NP.
* To evaluate the effect of dupilumab on participant reported outcomes and health related quality of life.
* To evaluate the efficacy of dupilumab 300 mg q2w up to Week 52.
* To evaluate the efficacy of dupilumab 300 mg q2w up to Week 24 followed by 300 mg every 4 weeks (q4w) up to Week 52.
* To evaluate the effect of dupilumab in the subgroups of participants with prior surgery and comorbid asthma including non-steroid anti-inflammatory drug exacerbated respiratory disease.
* To evaluate the safety of dupilumab in participants with bilateral NP.
* To evaluate functional dupilumab concentrations (systemic exposure) and incidence of treatment emergent anti-drug antibodies.


Options:
A: Absolute Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12: High Eosinophils -Intent to Treat (HEos-ITT) Population (Baseline, Week 12); Absolute Change From Baseline in FEV1 at Week 12: ITT Population (Baseline, Week 12)
B: Change From Baseline at Week 24 in Nasal Congestion/Obstruction Symptom Severity Score (Baseline, Week 24); Change From Baseline at Week 24 in Nasal Polyp Score (Baseline, Week 24)
C: Frequency of Clinical Asthma Exacerbations (CAEs) During 12 Months of Treatment (Day 1 to Month 12); Frequency of Each of the Two Criteria for Clinical Asthma Exacerbations (CAEs) (Day 1 to Month 12)
D: Change From Baseline at Week 24 in Nasal Congestion/Obstruction Symptom Severity Score (Baseline, Week 24); Change From Baseline at Week 24 in Nasal Polyp Score (Baseline, Week 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation Intervention for Women With HIV/AIDS
Brief Summary: As people with HIV/AIDS live longer, the burden of non-AIDS-related health problems such as cardiovascular diseases and cancers on these people have consistently increased. Smoking is one of the major contributing factors to these health problems and rates of cigarette smoking in this group are substantially higher than those of the general population: 40-70% vs. 17-10%. Especially, women living with HIV/AIDS seem to be more susceptible to the negative consequence of smoking than their male counterparts. They are also less likely to see tobacco dependence treatment for dual stigma associated with both conditions: HIV infection and nicotine addiction. This is a pilot study to develop smoking cessation intervention for these women.


Options:
A: Number of Participants With Abstinence (6-month follow-up)
B: Physician performance on refering patients that smoke cigarettes to the web intervention (pre-intervention, 6 months, 12 months and 24 months); Of the smokers who are referred to the web intervention, the number who go to the site (preintervention, 6 months, 12 months, 24 months); Point prevalence smoking cessation (6 months)
C: Self-reported Quit Attempts - The Primary Outcome is the Number of Veteran's Who Make a Self-reported Quit Attempt (as Defined as a 24-hour Point Prevalence Rate). (During 90-session intervention period); Number of Participants Who Progressed Along the Stage of Change Toward Action as Measured by the Transtheoretical Model of Change (Short Form) Questionnaire. This Will Identify Current Stage of Change for Each Subject. (During 90-session intervention period); Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days. (During 90-session intervention period); Self-reported Quit Attempts - The Primary Outcome is the Number of Veteran's Who Make a Self-reported Quit Attempt (as Defined as a 24-hour Point Prevalence Rate). (During the 6-month follow-up period); Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days. (During the 6-month follow-up period); Number of Participants Who Progressed Along the Stage of Change Toward Action as Measured by the Transtheoretical Model of Change (Short Form) Questionnaire. This Will Identify Current Stage of Change for Each Subject. (During the 6-month follow-up period)
D: 7-day point prevalence abstinence (Measured at Months 3, 6, and 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Open Label Trial of Nivolumab in Combination With Ipilimumab Versus Pemetrexed With Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma
Brief Summary: The purpose of this study is to test the effectiveness and tolerability of the combination of Nivolumab and Ipilimumab compared to Pemetrexed and Cisplatin or Carboplatin in patients with unresectable pleural mesothelioma.


Options:
A: Overall Survival (OS) (From date of randomisation until death from any cause, assessed up to 58 months)
B: Overall Survival (OS) (From randomization to the date of death (Up to 40 Months))
C: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v.4.0) in Participants With Solid Tumors (Parts A and A1) (Up to 28 days in Cycle 1); Number of Participants Who Experienced an Adverse Event (AE) (Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018)); Overall Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Integrated Radiology and Oncology (IRO): Melanoma Participants (Parts B Plus D) (Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015)); ORR According to RECIST 1.1 as Assessed by Independent Review Committee (IRC): Non-Small Cell Lung Cancer (NSCLC) Participants (Parts C Plus F) (Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015))
D: Response Rate (approximately 18 months); Overall Survival Phase 3 Interim Analysis (Approximately 18 months); Overall Survival (18 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects With Moderate-to- Severe Plaque Psoriasis
Brief Summary: The main purpose of this study is to evaluate the efficacy of the study drug mirikizumab in participants with moderate to severe plaque psoriasis.


Options:
A: Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) (Week 16)
B: Number of Participants With an American College of Rheumatology (ACR) 20 Response at Week 12 (Week 0 to Week 12)
C: Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16 During the Placebo-Controlled Phase (Baseline and Week 16 of the placebo-controlled phase)
D: Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks) (Baseline to 20 Weeks); Number of subjects prematurely discontinuing due to a Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks) (Baseline to 20 Weeks); Number of subjects reporting at least 1 Serious Adverse Event (SAE) during the Treatment Period (20 Weeks) (Baseline to 20 Weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects With Moderate-to- Severe Plaque Psoriasis
Brief Summary: The main purpose of this study is to evaluate the efficacy of the study drug mirikizumab in participants with moderate to severe plaque psoriasis.


Options:
A: 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)
B: Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16 (Baseline and Week 16)
C: N/A
D: Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) (Week 16)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects With Moderate-to- Severe Plaque Psoriasis
Brief Summary: The main purpose of this study is to evaluate the efficacy of the study drug mirikizumab in participants with moderate to severe plaque psoriasis.


Options:
A: Achievement of 75% or greater improvement from baseline in the Psoriasis Area and Severity Index (PASI) after 12 weeks of double-blind treatment.
B: Long-term Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, and AEs of Interest (From Day 169 to Day 729); Short-term Period: Number of Participants With ACR 20 Response at Day 169 (At Day 169 from Baseline)
C: Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) (Week 16)
D: Number of Participants Achieving a Greater Than or Equal to 75 Percentage Improvement From Baseline in Psoriasis Area and Severity Index (PASI 75) Score at Week 12 (Baseline and Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects With Moderate-to- Severe Plaque Psoriasis
Brief Summary: The main purpose of this study is to evaluate the efficacy of the study drug mirikizumab in participants with moderate to severe plaque psoriasis.


Options:
A: Percentage of Participants With a PASI 75 Response at Week 12 (Baseline and week 12)
B: Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16 (Week 16)
C: Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24 (Efficacy of Ixekizumab in Participants With Active Psoriatic Arthritis. Measure: American College of Rheumatology 20 Index [ACR20]) (Week 24)
D: Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) (Week 16)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Multicenter Randomized Controlled Trial of Efficacy and Safety of Renal Denervation for Resistant Hypertension
Brief Summary: Hypertension represents a significant global public health problem, contributing to vascular and renal morbidity, cardiovascular mortality, and economic burden. For a mostly asymptomatic disease, there is a huge challenge to maintain a good adherence and longtime persistence of drug use so as to adequately control it. Even so, a significant proportion of patients will develop resistant hypertension. In recent years, renal denervation has been argued as an effective means to address blood pressure problem in several non-Chinese clinical trials. The technique is to deliver low level radiofrequency energy through the renal artery wall to target the sympathetic nervous system and then modulate blood pressure.

Shanghai WiseGain Medical Devices Co., LTD has developed the WiseGo Catheter System, which is an irrigated radiofrequency ablation Catheter. With this Catheter, it is expected to improve blood pressure status among patients with resistant hypertension failing polypharmacy. The purpose of this randomized control trial is to obtain an assessment of the efficacy and safety of WiseGo renal denervation technique in the presence of three standard antihypertensive medications in Chinese patients.


Options:
A: office BP (baseline, 6 months); 24-ABPM (baseline, 6 months); Magnetic resonance imaging (MRI) (baseline, 3 and 6 months); Albuminuria (baseline, 6 months); Systemic RAS activity (baseline, 6 months); Vascular structure and function of large and small arteries (baseline, 6 months); Local RAS activity (baseline, 6 months)
B: To provide confirmation that renal denervation is safe and feasible. (3 years)
C: Change in average 24-hour systolic blood pressure by ambulatory blood pressure monitoring from baseline (3 months post-randomization)
D: Change in Systolic Blood Pressure From Baseline to 6 Months on 24-h Ambulatory Measurement (Follow-up Minus Baseline Measurement) (The primary endpoint has been assessed 6 months after randomization.); Change in Glomerular Filtration Rate (This endpoint has been assessed 6 months after randomization.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Contribution of a Smartphone Application to Acceptance and Commitment Therapy Group Treatment for Smoking Cessation: a Randomised Controlled Trial Investigating Its Efficacy, Mediators and Moderators
Brief Summary: The purpose of this study is to evaluate the efficacy of a smartphone application in enhancing Acceptance and Commitment Therapy group treatment for smoking cessation. This study also aims to elucidate the processes through which the treatment promotes smoking cessation and for whom it is most effective.


Options:
A: smoking cessation: 7-day point prevalence abstinence (6 months)
B: 30-day point prevalence abstinence (12 month post randomization)
C: Seven-day point-prevalence abstinence (6 weeks after beginning treatment); Seven-day point-prevalence abstinence (6 months after beginning treatment)
D: Point prevalence abstinence at 6 months (6 months after beginning treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Shortened Regimens for First Diagnosed Smear Positive Drug Susceptible Pulmonary Tuberculosis: a Randomised Controlled Non-inferiority Trial
Brief Summary: The purpose of the study is to evaluate the safety and efficacy of two shortened regimens for newly diagnosed smear positive drug susceptible pulmonary tuberculosis in comparison to World Health Organization recommended standard 6-month regimen.


Options:
A: To evaluate the safety and tolerability of ascending oral doses of PNU-100480 administered as extemporaneously prepared suspension (EPS) over 14 and 28 days in healthy adult volunteers. (Monitor adverse events daily; safety eval pre-dose, specified times , discharge, follow-up/as needed)
B: Evaluation of safety and tolerability of escalating single oral doses of PNU-100480. (Daily, Days 1-3 or 4, and 7-14 days after dosing.)
C: The percentage of participants with TB recurrence/relapse by 24 months after the end of treatment. (24 months after treatment completion for all 3 groups); Percentage of participants with treatment failure at either 4.5 months or 6 months after randomization. (4.5 months after randomization for experimental group1 and 2; 6 months after randomization for control group)
D: The Rate of Change in Colony Forming Units (CFUs) Using Non-linear Mixed Effects Modeling of the Serial Sputum Colony Counts (SSCC) Over 8 Weeks of Treatment. (8 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Multi-Center, Randomized, Double-Blind, 24-Week, Parallel Group, Placebo-Controlled Study to Investigate the Efficacy and Safety of Balovaptan (RO5285119) in Children and Adolescents Age 5-17 With Autism Spectrum Disorder (ASD)
Brief Summary: For participants enrolled prior to Version 6 of the protocol: This was a Phase II multi-center, randomized, double-blind, 24-week, 3-arm, parallel group, placebo-controlled study to investigate the efficacy, safety, and pharmacokinetics of balovaptan in children and adolescents aged 5-17 years with ASD who are high functioning (intelligence quotient \[IQ\] greater than or equal to \[\>=\] 70).

For participants enrolled according to Version 6 of the protocol: This was a Phase II multi-center, randomized, double-blind, 24-week, parallel group, placebo-controlled, 2-arm study with participants assigned either to a 10 milligram (mg) or equivalent dose of balovaptan, or placebo. All other study parameters remained as stated above.

There are three parts to this study: PK Part (Study part 1) included up to 8 weeks of treatment, Main Treatment Part (Study part 2) included 24 week of treatment, and the Open Label Extension Part (Study part 3) included Week 24 to Week 76 of treatment.

All participants that completed the 24-week treatment period were eligible to participate in an optional 52-week open-label extension (OLE) during which they received balovaptan treatment.


Options:
A: Aberrant Behavior Checklist- 2nd Edition (ABC-2): Irritability subscale raw score (Baseline to Week 12)
B: Change From Baseline in Vineland™-II Adaptive Behavior Scale Two Domain Composite (2DC) Score at Week 24 for Balovaptan (R05285119) 10 mg Equivalent Compared to Placebo (Baseline, Week 24)
C: Change in Clinical Global Impressions (CGI) Global Improvement (Change from Baseline at 8 Weeks); Change in Clinical Global Impressions (CGI) Global Improvement (Change from Open-Label Baseline at 8 Weeks); Change in Lethargy Subscale of the Aberrant Behavior Checklist (ABC) (Change from Baseline at 8 Weeks.); Change in Lethargy Subscale of the Aberrant Behavior Checklist (ABC) (Change from Open-Label Baseline at 8 Weeks)
D: Number of Participants With Improvement on the Clinical Global Impression-Improvement (CGI-I) Scale (6 Weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: REU-stop - Effect of Intensive Smoking Cessation Intervention on Smoking Cessation and Disease Activity in Patients With Rheumatoid Arthritis.
Brief Summary: This study aims to test the effect of an intensive smoking cessation intervention (motivational counseling combined with nicotine replacement) on smoking cessation and disease activity in patients with Rheumatoid Arthritis (RA). Half of the patients will participate in a smoking cessation intervention; the other half will receive usual treatment.


Options:
A: Self-reported continuous smoking cessation validated by exhaled carbon-monoxide at 3 months follow-up (3 months post-intervention); EULAR clinical response (an improvement in DAS28 of >0.6) at 3 months follow-up (3 months post-intervention)
B: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
C: Smoking Abstinence (12 months)
D: Prolonged Smoking Abstinence: 4 Weeks Post Quit-Date (4 Weeks Following Smoking Quit Date (Study week 7)); Prolonged Smoking Abstinence: 12 Weeks Post Quit-Date (12 Weeks Following Smoking Quit Date (Study week 15)); 7-Day Point Prevalence Smoking Abstinence: 4 Weeks Post Quit-Date (4 Weeks Following Smoking Quit Date (Study week 7)); 7-Day Point Prevalence Smoking Abstinence: 12 Weeks Post Quit-Date (12 Weeks Following Smoking Quit Date (Study week 15)); 7-Day Point Prevalence Smoking Abstinence: 26 Weeks Post Quit-Date (26 Weeks Following Smoking Quit Date (Study week 29)); 7-Day Point Prevalence Smoking Abstinence: 52 Weeks Post Quit-Date (52 Weeks Following Smoking Quit Date (Study week 55))

Answer: A