TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Success of Tocilizumab in RA Patients With Remission Induction and Sustained Efficacy After Discontinuation
Brief Summary: The objective of this study is to investigate the efficacy and safety of the humanized anti-human IL-6 receptor monoclonal antibody tocilizumab (TCZ) either in monotherapy or in combination therapy with methotrexate (MTX) in patients with an inadequate response to treatment with MTX.

Furthermore, in patients who have been able to achieve control of disease activity via the above therapy, we investigate the possibility of stopping TCZ and verify safety when TCZ is restarted after disease recurrence.


Options:
A: Double-blind Period: Mean Synovitis Scores at Baseline As Measured by the Rheumatoid Arthritis Clinical Trials 6 (OMERACT 6) Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) (At baseline); Double-blind Period: Mean Change From Baseline in OMERACT 6 Wrist Synovitis Score: Planned Analysis Using Non-Parametric ANCOVA (Baseline to Day 113); Double-blind Period: Mean Change From Baseline in OMERACT 6 Wrist Synovitis Score: Post Hoc Sensitivity Analysis Using Parametric ANCOVA Analysis (Baseline to Day 113)
B: DAS28-ESR remission at 24 weeks (at 24 week); Changes over time in the number of patients maintaining discontinuation (maintenance rate) (Week 52 to Week 104)
C: American College of Rheumatology 20 Response (ACR20) (12 weeks)
D: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 (Month 6); Changes From Baseline in Modified Total Sharp Score (mTSS) at Month 6 (Baseline, Month 6); Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 (Baseline, Month 3); Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6 (Month 6)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 64-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Active Controlled Study to Evaluate the Effect of QVA149 (110/50 μg o.d.) vs NVA237 (50 μg o.d.) and Open-label Tiotropium (18 μg o.d.) on COPD Exacerbations in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: This study is designed to assess the effect of once-daily QVA149 on COPD exacerbations in patients with severe to very severe COPD.


Options:
A: Percentage of Patients to Experience at Least One Treatment-emergent Adverse Event (TEAE) (Up to study Week 56 ± 3 days)
B: Rate of COPD Exacerbations (52 weeks)
C: Rate of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in QVA149 and NVA237 Treatment Arms During the Treatment Period. (64 weeks)
D: FEV1 AUC0-3h Response at 12 Weeks; Defined as Change From Baseline to Week 12 (baseline and 12 weeks); Trough FEV1 Response at 12 Weeks; Defined as Change From Baseline to Week 12 (baseline and 12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 64-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Active Controlled Study to Evaluate the Effect of QVA149 (110/50 μg o.d.) vs NVA237 (50 μg o.d.) and Open-label Tiotropium (18 μg o.d.) on COPD Exacerbations in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: This study is designed to assess the effect of once-daily QVA149 on COPD exacerbations in patients with severe to very severe COPD.


Options:
A: Change in serum C-reactive protein levels over 3 months between treatment groups.
B: Trough Forced Expiratory Volume in 1 Second (FEV1) Assessed by Spirometry 24 Hour Post Dose After 12 Weeks of Treatment (after 12 weeks of treatment)
C: Rate of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in QVA149 and NVA237 Treatment Arms During the Treatment Period. (64 weeks)
D: Trough FEV1 (L) at 28 Weeks on Treatment (Week 28); Trough Forced Expiratory Volume in the First Second (FEV1) (L) at 12 Weeks on Treatment (Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 64-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Active Controlled Study to Evaluate the Effect of QVA149 (110/50 μg o.d.) vs NVA237 (50 μg o.d.) and Open-label Tiotropium (18 μg o.d.) on COPD Exacerbations in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: This study is designed to assess the effect of once-daily QVA149 on COPD exacerbations in patients with severe to very severe COPD.


Options:
A: Exercise Tolerance Comparison Between QVA149 and Placebo Groups (3 weeks)
B: Rate of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in QVA149 and NVA237 Treatment Arms During the Treatment Period. (64 weeks)
C: FEV1 AUC0-3h Response (baseline and 12 weeks); Trough FEV1 Response (Change From Baseline) (baseline and 12 weeks); St. George's Respiratory Questionnaire (SGRQ) Total Score Based on Data From This Individual Study (12 weeks treatment); St. George's Respiratory Questionnaire (SGRQ) Total Score Based on Combined Dataset From This Study and the Replicate Study NCT01964352 (12 weeks treatment)
D: Change From Baseline in 1-hour Morning Post-dose Forced Expiratory Volume in One Second (FEV1) (Week 24 of treatment); Change From Baseline in Morning Trough Forced Expiratory Volume in One Second (FEV1) (Week 24 of treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Project 3: Identifying Optimal Strategies of Increasing Smokers' Adherence to Cessation Medications
Brief Summary: Many smokers fail to take their smoking cessation medication as recommended. This research is designed to identify treatments that improve the use of cessation medications and to determine whether an increase in medication use results in increased cessation success. This research will also identify treatments that help people stay quit after a quit attempt and will pioneer more efficient research methods.


Options:
A: Point Prevalence Abstinence (5 month follow-up)
B: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
C: Self-Reported 7-Day Point-Prevalence Abstinence (Assessed at 52 weeks after target quit day)
D: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Project 3: Identifying Optimal Strategies of Increasing Smokers' Adherence to Cessation Medications
Brief Summary: Many smokers fail to take their smoking cessation medication as recommended. This research is designed to identify treatments that improve the use of cessation medications and to determine whether an increase in medication use results in increased cessation success. This research will also identify treatments that help people stay quit after a quit attempt and will pioneer more efficient research methods.


Options:
A: Self-reported, Prolonged Abstinence From Smoking Between a Quit Date and 6 Months Afterwards. (6 months from participant's quit date)
B: 7-day point prevalence abstinence from smoking (6 months after enrollment)
C: Smoking abstinence rate (At 12 months); Cost-effectiveness (At 12 months)
D: Self-Reported 7-Day Point-Prevalence Abstinence (Assessed at 52 weeks after target quit day)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Project 3: Identifying Optimal Strategies of Increasing Smokers' Adherence to Cessation Medications
Brief Summary: Many smokers fail to take their smoking cessation medication as recommended. This research is designed to identify treatments that improve the use of cessation medications and to determine whether an increase in medication use results in increased cessation success. This research will also identify treatments that help people stay quit after a quit attempt and will pioneer more efficient research methods.


Options:
A: Self-Reported 7-Day Point-Prevalence Abstinence (Assessed at 52 weeks after target quit day)
B: Number of Subjects With Four Week Continuous Quit Rate (CQR) (Week 9 through Week 12)
C: Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt) (weeks 9 through 12)
D: 7-day Point Prevalence Smoking Abstinence at End of Treatment (Week 8) (8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicener, Randomised, Double-blind, Placebo-controlled Study, to Assess the Long Term Safety of 52 Weeks Treatment With QVA149 (110 ug Indacaterol/50ug Glycopyrrolate) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The study is designed to provide long-term safety data for QVA149 in patients with moderate to severe chronic obstructive pulmonary disease (COPD).


Options:
A: Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) (Baseline to Endpoint (13 weeks)); Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1 (Baseline to Endpoint (13 weeks))
B: Change From Baseline in Morning Pre-dose Trough FEV1 (At Week 24)
C: Number of Participants With Adverse Events, Serious Adverse Events or Death (52 weeks + Follow-up (Up to Day 394))
D: Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (0-3h) Response on Day 169. (1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 169.); Trough FEV1 Response on Day 170. (1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 23 h and at 23 h 50 min after inhalation of study medication on Day 170); Saint George's Respiratory Questionnaire (SGRQ) Total Score on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287) (Day 169)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicener, Randomised, Double-blind, Placebo-controlled Study, to Assess the Long Term Safety of 52 Weeks Treatment With QVA149 (110 ug Indacaterol/50ug Glycopyrrolate) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The study is designed to provide long-term safety data for QVA149 in patients with moderate to severe chronic obstructive pulmonary disease (COPD).


Options:
A: Inspiratory Capacity at Rest Measured at 60 Minutes Post-dose (Day 43, 60 minutes post-dose after 6 weeks of each treatment)
B: Percentage of Patients to Experience at Least One Treatment-emergent Adverse Event (TEAE) (Up to study Week 56 ± 3 days)
C: Inspiratory Capacity at Rest Before Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap (6 weeks); Endurance Time During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap (6 weeks)
D: Number of Participants With Adverse Events, Serious Adverse Events or Death (52 weeks + Follow-up (Up to Day 394))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: LUX-Lung 6: A Randomized, Open-label, Phase III Study of BIBW 2992 Versus Chemotherapy as First-line Treatment for Patients With Stage IIIB or IV Adenocarcinoma of the Lung Harbouring an EGFR Activating Mutation
Brief Summary: To investigate the efficacy and safety of BIBW 2992 compared to standard first-line chemotherapy in patients with stage IIIB or IV adenocarcinoma of the lung harbouring an EGFR activating mutation


Options:
A: Progression Free-survival (From the date of randomization to the date of last follow up, assessed up to 24 months)
B: Progression-free Survival (Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 168)
C: Median Progression Free Survival (PFS) (Months) (At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomisation until progression); Percentage of Participants in Progression Free Survival at 6, 12, and 18 Months (At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomisation until progression)
D: Overall Survival Time (OS) (Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Randomized Trial of the Polo-like Kinase 1 Inhibitor BI 6727 Monotherapy Versus Investigator´s Choice Chemotherapy in Ovarian Cancer Patients Resistant or Refractory to Platinum-based Cytotoxic Therapy
Brief Summary: This is an international, randomized phase II trial. The aim is to assess the efficacy and the safety of BI 6727 Versus investigator's best choice single agent cytotoxic in recurrent third and fourth lines platinum resistant/refractory ovarian cancer.

100 patients will be randomised at the study entry to receive either BI 6727 (Arm A: 50 patients) or non-platinum single agent cytotoxic (Arm B: 50 patients) Treatment will be continued until disease progression or unacceptable toxicity. Primary endpoint: disease control rate at week 24 according to Response Evaluation Criteria In Solid Tumours version 1.1.

Secondary endpoints: efficacy (progression free survival, overall survival, biological tumour response, biological progression free survival assessed by serum CA 125 according to Gynecologic Cancer Intergroup criteria, safety according to the NCI CTCAE v.3, disease symptoms control assessed by the EORTC QLQ-C30, QLQ-OV28 and individual symptoms questionnaires, pharmacokinetics of BI 6727.

Others endpoints: biomarkers and pharmacogenetics analysis (optional)


Options:
A: Disease Control Rate (DCR) at Week 24 According to Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1 (Week 24)
B: To demonstrate superiority in progression-free survival of TLK286 in combination with liposomal doxorubicin as compared with the active control arm liposomal doxorubicin (Once 244 planned pts. received at least 2 cycles of study treatment(s))
C: Progression-free Survival (PFS) Differences Between Ixabepilone Alone and Ixabepilone + Bevacizumab (Up to 37 months)
D: Overall Survival (OS) (From date of randomizationrandomization to date of death from any cause assessed up to 40 months); Progression-free survival (From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs earlier, assessed up to 40 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Randomized Trial of the Polo-like Kinase 1 Inhibitor BI 6727 Monotherapy Versus Investigator´s Choice Chemotherapy in Ovarian Cancer Patients Resistant or Refractory to Platinum-based Cytotoxic Therapy
Brief Summary: This is an international, randomized phase II trial. The aim is to assess the efficacy and the safety of BI 6727 Versus investigator's best choice single agent cytotoxic in recurrent third and fourth lines platinum resistant/refractory ovarian cancer.

100 patients will be randomised at the study entry to receive either BI 6727 (Arm A: 50 patients) or non-platinum single agent cytotoxic (Arm B: 50 patients) Treatment will be continued until disease progression or unacceptable toxicity. Primary endpoint: disease control rate at week 24 according to Response Evaluation Criteria In Solid Tumours version 1.1.

Secondary endpoints: efficacy (progression free survival, overall survival, biological tumour response, biological progression free survival assessed by serum CA 125 according to Gynecologic Cancer Intergroup criteria, safety according to the NCI CTCAE v.3, disease symptoms control assessed by the EORTC QLQ-C30, QLQ-OV28 and individual symptoms questionnaires, pharmacokinetics of BI 6727.

Others endpoints: biomarkers and pharmacogenetics analysis (optional)


Options:
A: Determination of the optimal doses for pazopanib (phase I) (42 months); Overall response rate according to RECIST criteria / clinical benefit (stable disease or partial response or complete response) (phase II) (12 weeks after start of treatment)
B: 6-month Progression-Free Rate (6 months after initiation of study treatment)
C: Disease Control Rate (DCR) at Week 24 According to Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1 (Week 24)
D: Progression-Free Survival (PFS): Independent Radiologist Review (From the date of randomization until the date of disease progression or death, as assessed for approximately 3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Parallel-Group, Randomized, 10-Week, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of 50 mg Of DVS SR In The Treatment Of Peri- And Postmenopausal Women With Major Depressive Disorder
Brief Summary: A multicenter, 10-week study to evaluate the efficacy and safety of 50 mg of desvenlafaxine succinate sustained-release formulation (DVS SR) versus placebo in the treatment of peri- and postmenopausal women with major depressive disorder


Options:
A: Return to work (at 6, 12, 24 and 60 months)
B: Change in the Montgomery-Asberg Depression (From baseline (end of Phase A [Week 8]) to week 14)
C: Change From Baseline in Hamilton Depression Scale (HAM-D17) at Week 8 (Baseline, Week 8)
D: Time to return to work (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Venue-Based Recruitment and HIV Prevention for Alcohol and Other Drug (AOD) Using Couples in South Africa
Brief Summary: Couples who use alcohol and other drugs (AOD) in South Africa are at high risk for engaging in risky sex behavior within their relationships and with other sexual partners. In addition, high levels of gender-based violence (GBV) in the Cape Town area intersect with AOD abuse and sex behavior. All of these interconnections raise concern for the importance of HIV prevention strategies within or surrounding drinking venues, where many of these behaviors occur.

The specific aims of this study are as follows:

Aim 1. To characterize the types of drinking venues (e.g., licensure status, size, plumbing, type of alcohol provided), their immediate context (e.g., observed availability and use of other drugs, observable violence and sexual activity), and surrounding neighborhood characteristics (e.g., quality of streets, building structures, and availability of electricity and plumbing) in the sampled neighborhood blocks in several large Black/African and Coloured communities in Cape Town, South Africa.

Aim 2. To refine through qualitative methods the proposed interventions in relation to skills-building to address gender-role expectations, sexual partnering, gender and power, violence, and environments where drinking and sexual risk behaviors occur.

Aim 3. To conduct a randomized group trial to compare the relative efficacy of a comprehensive intervention (Condition 3: Enhanced Couples) to the gender-focused intervention (Condition 2: Gender) and to (Condition 1: Men's Control and Women's CoOp) on reducing alcohol and other drug (AOD) use, sexual risk behavior, and gender-based violence at 6 month follow-ups. Aim 4. To assess the mechanisms through which the intervention effects may occur (e.g., mediators involving self-efficacy and condom mastery, negotiation, and communication skills) and to identify groups for whom the interventions have the greatest effect (e.g., partner characteristics such as race, gender, and age and neighborhood factors such as poverty) on study outcomes of AOD use, sexual risk, and gender-based violence.


Options:
A: Percentage of Women Who Test Ethyl Glucuronide (EtG) Negative (3-, 6-, and 9-month post-baseline)
B: Reduced alcohol use (6 month follow up)
C: Alcohol use and STI/HIV infection (up to 12 months)
D: Change in Alcohol Use Disorders Identification Test (AUDIT) Scale Score From Baseline to 6-month Post-baseline. (Baseline and 6 months post-baseline)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase III Study of 5-Fluorouracil-based Regimen With or Without Oxaliplatin as 2nd Line Treatment of Advanced or Metastatic Pancreatic Cancer in Patients Who Have Previously Received Gemcitabine-based Chemotherapy
Brief Summary: Primary Objective:

To demonstrate that the addition of oxaliplatin to 5-Fluorouracil (5-FU) and Leucovorin (LV) will improve the Progression-Free Survival (PFS). Progression is based on RECIST (Response Evaluation Criteria In Solid Tumors) criteria or death

Secondary Objective:

To evaluate other measures of tumor responses, safety, quality of life (QoL), and health utility assessment.


Options:
A: Progression-Free Survival (PFS) (Within the 3 months of study treatment)
B: Overall Survival (From randomization until death due to any cause or until the data cutoff of 15-March-2013 (up to 24 months))
C: Overall Survival (OS) (Baseline of Phase 2 to death or until at least 1 year after the randomization of the last participant)
D: Determine if the Treatment of AMG 479 at 12 mg/kg and/or 20 mg/kg in Combination With Gemcitabine Improves Overall Survival as Compared With Placebo in Combination With Gemcitabine in Subjects With Metastatic Adenocarcinoma of the Pancreas (From randomization up to 20 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Multi-center Observational Study With Blinded, Nested Case:Control Analyses to Evaluate the Performance of the Verinata Health Prenatal Aneuploidy Diagnostic Test
Brief Summary: The primary objective of this study is to determine the performance characteristics (sensitivity and specificity) of the Verinata Health Test to detect fetal Trisomy 21 (T21) compared to karyotype results obtained by amniocentesis or chorionic villus sampling (CVS).

Secondary objectives are to assess performance of the test to detect male gender (XY) and other less common aneuploidies (Trisomy 13 (T13), Trisomy 18 (T18), and Turner Syndrome (45, X)) compared to clinical fetal karyotype.


Options:
A: Difference in sensitivity and specificity of Ariosa Harmony™ Prenatal Test (AUCt) and combined first-trimester screening for detection of T21. (Enrollment to delivery)
B: Comparison of screen positive rates between investigational testing results and conventional screening results (standard of care). (12 months)
C: Classification of fetal status as affected or not affected for Trisomy 21 based on Artemis Health Test on maternal blood. (10 months)
D: The RNA study is an observational trial whose primary aim is to document the performance (sensitivity and specificity) of a laboratory developed test (LDT), using fetal nucleic acid in maternal plasma to identify Down syndrome in early pregnancy. (Within 1st and 2nd trimesters)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Sustaining Tobacco Abstinence After Incarceration
Brief Summary: The purpose of this study is to determine the extent to which an Intentional Behavioral Intervention will increase tobacco quit rates post release among incarcerated men and women.


Options:
A: Smoking abstinence (2 years)
B: Quit Attempt(s) (Any time within 26 weeks)
C: Point prevalence abstinence
D: smoking cessation (6-months)

Answer: A