TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Two-period, Three-sequence, Partial Crossover Study to Evaluate the Efficacy and Safety of Subcutaneous Administration of 2000 IU of C1 Esterase Inhibitor [Human] Liquid for Injection for the Prevention of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema
Brief Summary: The purpose of this study is to assess the efficacy and safety of subcutaneous administration of a liquid formulation of C1 esterase inhibitor for the prevention of angioedema attacks in adolescent and adult subjects with hereditary angioedema.


Options:
A: Time-Normalized Number of Attacks (NNA) for Participants During a Treatment Period (Weeks 1 to 14 for treatment period 1 and 2)
B: Number of Participants With Serious Adverse Events (SAE) and Treatment-Emergent Adverse Events (TEAE) (From Day 1 up to final follow-up (Day 123))
C: Part 1: The Rate of Investigator-confirmed HAE Attacks During Dosing in the Entire 24-week Treatment Period (Day 1 to Day 168) (24 weeks); Part 2 & 3: To Evaluate the Long-term Safety and Tolerability of Berotralstat 110 and 150 mg in Subjects With HAE (Part 2: 24 weeks (Days 169 to 337). Part 3: 48 weeks (Days 338 to 674).)
D: Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attacks During Treatment Period (From Day 0 to Day 182)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimizing Text Messaging to Improve Adherence to Web-Based Cessation Treatment
Brief Summary: This study is comprised of 2 phases to study the impact of a text message system on overall adherence to a web-based smoking cessation program. Phase I uses a full factorial design to identify the most optimal text message intervention to maximize adherence to the BecomeAnEX.org smoking cessation program. Phase II is a randomized controlled trial that compares regular BecomeAnEX users to those who will receive the optimized text message intervention (from Phase I) in conjunction with BecomeAnEX for impact on long-term abstinence.


Options:
A: 7-day point prevalence abstinence at 3 months (3 months post baseline); 7-day point prevalence abstinence at 6 months (6 months post baseline); 7-day point prevalence abstinence at 12 months (12 months post baseline)
B: Self-reported 7-day Point Prevalence Abstinence From Smoking That Was Sustained at 60 Days After the Quit Date (60 days after quit date)
C: Phase I - Composite adherence metric (3 months); Phase II - 30-day point prevalence abstinence (9 months post randomization)
D: Change in tobacco smoking (6 months); Change in level of physical activity (6 months); Change in diet quality (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimizing Text Messaging to Improve Adherence to Web-Based Cessation Treatment
Brief Summary: This study is comprised of 2 phases to study the impact of a text message system on overall adherence to a web-based smoking cessation program. Phase I uses a full factorial design to identify the most optimal text message intervention to maximize adherence to the BecomeAnEX.org smoking cessation program. Phase II is a randomized controlled trial that compares regular BecomeAnEX users to those who will receive the optimized text message intervention (from Phase I) in conjunction with BecomeAnEX for impact on long-term abstinence.


Options:
A: Validated 7-day point prevalence tobacco abstinence (6 months after discharge)
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: Point prevalence abstinence at 6 months (6 months after beginning treatment)
D: Phase I - Composite adherence metric (3 months); Phase II - 30-day point prevalence abstinence (9 months post randomization)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimizing Text Messaging to Improve Adherence to Web-Based Cessation Treatment
Brief Summary: This study is comprised of 2 phases to study the impact of a text message system on overall adherence to a web-based smoking cessation program. Phase I uses a full factorial design to identify the most optimal text message intervention to maximize adherence to the BecomeAnEX.org smoking cessation program. Phase II is a randomized controlled trial that compares regular BecomeAnEX users to those who will receive the optimized text message intervention (from Phase I) in conjunction with BecomeAnEX for impact on long-term abstinence.


Options:
A: Phase I - Composite adherence metric (3 months); Phase II - 30-day point prevalence abstinence (9 months post randomization)
B: Self-reported 7-day Point Prevalence Abstinence From Smoking That Was Sustained at 60 Days After the Quit Date (60 days after quit date)
C: Smoking abstinence (Six months post-treatment)
D: Smoking cessation (Change in smoking status from baseline at 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Open Label Study Evaluating the Safety of Apixaban in Subjects With Cancer Related Venous Thromboembolism
Brief Summary: This randomized phase III trial studies the side effects of and compares apixaban and dalteparin in reducing blood clots in patients with cancer-related venous thromboembolism. Venous thromboembolism is a condition in which a blood clot forms in a vein and then breaks off and moves through the bloodstream. Patients with cancer are at increased risk for venous thromboembolism. Apixaban and dalteparin are drugs used to prevent blood clots from forming or to treat blood clots that have formed. It is not yet known whether apixaban or dalteparin is more effective in reducing blood clots in patients with cancer related venous thromboembolism.

ADAM-VTE


Options:
A: Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period (6 months)
B: 6 Month Bleeding Rate (Up to 6 months)
C: Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE (For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180))
D: Composite of Recurrent VTE or VTE Death at 36 Months (36 months); Composite of Recurrent VTE or VTE Death at 18 Months (18 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Open Label Study Evaluating the Safety of Apixaban in Subjects With Cancer Related Venous Thromboembolism
Brief Summary: This randomized phase III trial studies the side effects of and compares apixaban and dalteparin in reducing blood clots in patients with cancer-related venous thromboembolism. Venous thromboembolism is a condition in which a blood clot forms in a vein and then breaks off and moves through the bloodstream. Patients with cancer are at increased risk for venous thromboembolism. Apixaban and dalteparin are drugs used to prevent blood clots from forming or to treat blood clots that have formed. It is not yet known whether apixaban or dalteparin is more effective in reducing blood clots in patients with cancer related venous thromboembolism.

ADAM-VTE


Options:
A: 6 Month Bleeding Rate (Up to 6 months)
B: Incidence of Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or VTE-Related Death During 6 Months of Treatment (Day 1 to Week 24 + 2 Days or 355 days (Discontinued Early))
C: Recurrent deep venous thrombosis or venous thromboembolism (6 months); Occurrence of fatal or major bleeding (6 months); Mortality related to massive pulmonary embolism (6 months)
D: Composite Primary Endpoint (From the time of randomisation until Week 12, 84 days after randomisation including a visit window of 7 days.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Open Label Study Evaluating the Safety of Apixaban in Subjects With Cancer Related Venous Thromboembolism
Brief Summary: This randomized phase III trial studies the side effects of and compares apixaban and dalteparin in reducing blood clots in patients with cancer-related venous thromboembolism. Venous thromboembolism is a condition in which a blood clot forms in a vein and then breaks off and moves through the bloodstream. Patients with cancer are at increased risk for venous thromboembolism. Apixaban and dalteparin are drugs used to prevent blood clots from forming or to treat blood clots that have formed. It is not yet known whether apixaban or dalteparin is more effective in reducing blood clots in patients with cancer related venous thromboembolism.

ADAM-VTE


Options:
A: Number of participants with newly onset of symptomatic venous thromboembolism (VTE) (Up to 12 months); Number of clinically relevant bleedings (Up to 2 days after last dose)
B: Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE (For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180))
C: 6 Month Bleeding Rate (Up to 6 months)
D: Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment (3-, 6- or 12-month study treatment period)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3, Prospective, Randomized, Multi-center Clinical Study Comparing the Safety and Efficacy of BAX 855 Following PK-guided Prophylaxis Targeting Two Different FVIII Trough Levels in Subjects With Severe Hemophilia A
Brief Summary: 1. To compare the efficacy and safety of pharmacokinetic (PK)-guided treatment with BAX 855 targeting FVIII trough levels of 1-3% and approximately 10% (8-12%)
2. To further characterize pharmacokinetic (PK) and pharmacodynamic (PD) parameters of BAX 855


Options:
A: Percentage of Participants With a Total Annualized Bleeding Rate (ABR) of Zero for Second Six Months (Day 183 to Day 364 (6 months))
B: Part A - Area Under the Drug Concentration-time Curve (AUC) (Samples taken at pre-injection, and at 0.25, 0.5, 1, 3, 6, 8, 24, 30 and 48 hours post injection. AUC calculated from time of injection to infinity.); Part A - Half-life (t 1/2) (Samples taken at pre-injection, and at 0.25, 0.5, 1, 3, 6, 8, 24, 30 and 48 hours post injection.); Part B - Annualized Number of Total Bleeds (12 months after randomization)
C: Incidence Rate of FVIII Inhibitor Development (up to 52 weeks ± 2 weeks); Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) (up to 52 weeks + 30 days ± 1 week); Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values From Baseline (up to 52 weeks ± 2 weeks); Number of Participants With Clinically Relevant Abnormalities in Vital Signs or Relevant Changes From Baseline in Vital Signs (up to 52 weeks ± 2 weeks); Annualized Bleeding Rate (up to 52 weeks ± 2 weeks (efficacy period as defined in description)); Comparison of Annualized Bleeding Rates: Arm 1 Versus Arm 3 (up to 52 weeks ± 2 weeks (efficacy period as defined in description)); Area Under the Curve (AUC) Per Dose (One-stage Clotting Assay) (See Measure Description for complete time frame.); Elimination Half Life (t1/2; One-stage Clotting Assay) (See Measure Description for complete time frame.); Clearance (CL; One-stage Clotting Assay) (See Measure Description for complete time frame.); Mean Residence Time (MRT; One-stage Clotting Assay) (See Measure Description for complete time frame.); Incremental Recovery (One-stage Clotting Assay) (See Measure Description for complete time frame.)
D: Number of adverse events (AEs) (From first trial drug administration (day 1) to 11 weeks after the first trial product administration)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke 3
Brief Summary: This is a study to evaluate the hypothesis that FDA cleared thrombectomy devices plus medical management leads to superior clinical outcomes in acute ischemic stroke patients at 90 days when compared to medical management alone in appropriately selected subjects with the Target mismatch profile and an MCA (M1 segment) or ICA occlusion who can be randomized and have endovascular treatment initiated between 6-16 hours after last seen well.


Options:
A: Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2. (at 90 days post randomization); Death Due to Any Cause (within 90 days post randomization); Symptomatic Intracranial Hemorrhage (within the first 30 hours post IV rt-PA)
B: The Distribution of Scores on the Modified Rankin Scale (mRS) at Day 90 (Day 90)
C: Weighted Modified Rankin Scale (mRS) Score, Lead Co-Primary Efficacy Outcome (90 days); Functional Independence (mRS 0-2), Nested Co-Primary Efficacy Outcome (90 days); Stroke-related Mortality, Primary Safety Outcome (90 days)
D: To assess whether IA thrombolysis, as compared to IV rt-PA, increases survival free of disability (modified Rankin score of zero or 1) at 3 months. (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke 3
Brief Summary: This is a study to evaluate the hypothesis that FDA cleared thrombectomy devices plus medical management leads to superior clinical outcomes in acute ischemic stroke patients at 90 days when compared to medical management alone in appropriately selected subjects with the Target mismatch profile and an MCA (M1 segment) or ICA occlusion who can be randomized and have endovascular treatment initiated between 6-16 hours after last seen well.


Options:
A: Score on the modified Rankin scale (3 months)
B: Shift in the mRS score, defined by a proportional odds model. (90 days)
C: The Distribution of Scores on the Modified Rankin Scale (mRS) at Day 90 (Day 90)
D: composite of functional independence at 3 months and absence of medical complication occurring by day 7 after endovascular therapy for anterior circulation AIS (Day 90)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke 3
Brief Summary: This is a study to evaluate the hypothesis that FDA cleared thrombectomy devices plus medical management leads to superior clinical outcomes in acute ischemic stroke patients at 90 days when compared to medical management alone in appropriately selected subjects with the Target mismatch profile and an MCA (M1 segment) or ICA occlusion who can be randomized and have endovascular treatment initiated between 6-16 hours after last seen well.


Options:
A: The Distribution of Scores on the Modified Rankin Scale (mRS) at Day 90 (Day 90)
B: Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2. (at 90 days post randomization); Death Due to Any Cause (within 90 days post randomization); Symptomatic Intracranial Hemorrhage (within the first 30 hours post IV rt-PA)
C: modified Rankin scale (mRS) 0-1 (favourable outcome) at Day 90 (at day 90)
D: Shift in the mRS score, defined by a proportional odds model. (90 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke 3
Brief Summary: This is a study to evaluate the hypothesis that FDA cleared thrombectomy devices plus medical management leads to superior clinical outcomes in acute ischemic stroke patients at 90 days when compared to medical management alone in appropriately selected subjects with the Target mismatch profile and an MCA (M1 segment) or ICA occlusion who can be randomized and have endovascular treatment initiated between 6-16 hours after last seen well.


Options:
A: Modified Rankin Scale (mRS) 0-1 (3 months)
B: The Distribution of Scores on the Modified Rankin Scale (mRS) at Day 90 (Day 90)
C: Assessment of modified Rankin Scale shift analysis at 90 days after onset (90 days)
D: Modified Rankin Scale 0-1 (90 days after stroke onset)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of a Supervised Versus Non-supervised Exercise Program on Adherence and Functional Outcomes in Colorectal Cancer Patients
Brief Summary: Investigation into prehabilitation by increasing the supervision of exercise in patients undergoing colorectal resection for cancer and comparing with patients involved in a rehabilitation group receiving exercise after surgery.


Options:
A: Six Minute Walk Test (6MWT) (up to 8 weeks after surgery)
B: The incidence of postoperative complications, classified by Clavien Scale (Time Frame: 30days or the postoperative hospital stay if longer than 30 days)
C: 6 minute walk test (6MWT) (up to 8 weeks after surgery)
D: Oxygen consumption (VO2) (4 weeks (before surgery))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of a Supervised Versus Non-supervised Exercise Program on Adherence and Functional Outcomes in Colorectal Cancer Patients
Brief Summary: Investigation into prehabilitation by increasing the supervision of exercise in patients undergoing colorectal resection for cancer and comparing with patients involved in a rehabilitation group receiving exercise after surgery.


Options:
A: six minute walk test (baseline, preop, 4 weeks, 8weeks postop)
B: Maintain or improve physical fitness (anaerobic threshold measured by CPET)after treatment with neoadjuvant chemoradiotherapy in colorectal cancer patients. (3 years)
C: Oswestry Disability Index (ODI) (Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery)
D: Six Minute Walk Test (6MWT) (up to 8 weeks after surgery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: HELP Study: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate DX-2930 For Long-Term Prophylaxis Against Acute Attacks of Hereditary Angioedema (HAE)
Brief Summary: This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of DX-2930 in preventing acute angioedema attacks in patients with Type I and Type II HAE.


Options:
A: Normalized Number of Angioedema Attacks During the Treatment Period (From Visit 1 (Week 1) up to Visit 16 (Week 8) during each treatment period)
B: Part 1: The Rate of Investigator-confirmed HAE Attacks During Dosing in the Entire 24-week Treatment Period (Day 1 to Day 168) (24 weeks); Part 2 & 3: To Evaluate the Long-term Safety and Tolerability of Berotralstat 110 and 150 mg in Subjects With HAE (Part 2: 24 weeks (Days 169 to 337). Part 3: 48 weeks (Days 338 to 674).)
C: Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attacks During Treatment Period (From Day 0 to Day 182)
D: The Mean Time Normalized Number of HAE Attacks Per Month in Subjects With C1-INH HAE During Treatment Period 1 (13 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Investigation of the Gather mHealth Platform on Diabetics' Behavior and Health Outcomes.
Brief Summary: The purpose of this trial is to explore the impact of the Gather Health diabetes management platform diabetics' health behaviors and health outcomes and how providers and diabetics interact with the Gather Health platform.


Options:
A: Change in HbA1c (6 months)
B: Blood pressure at target level (140/85 or lower), total cholesterol at target level (4.5 mmol/l or lower), LDL cholesterol at target level (2.5 mmol/l or below), waist circumference at target level (<=94 men, <=80 cm women) (12 months from start of intervention); For patients with diabetes: blood HbA1c at target level (7% or less) (12 months from start of intervention)
C: Change From Baseline in Glycosylated Hemoglobin (%) (Baseline to 12 months)
D: Diabetes Control (Baseline, 3months, 6months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Multi-center Phase III Clinical Study to Assess the Efficacy and Safety of Surufatinib Compared to Placebo in Patients With Advanced Extrapancreatic Neuroendocrine Tumors
Brief Summary: A randomized, double-blind, placebo controlled, multi-center Phase III study to assess the efficacy of Surufatinib 300 mg once a day in treating advanced extrapancreatic neuroendocrine tumors.


Options:
A: Proportion of Patients Alive and Progression-free at 6 Months (6 months)
B: Time to Progression Free Survival (PFS) Based as Per Investigator Using Kaplan-Meier Methodology (Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010)
C: Progression Free Survival (PFS) (9 months after the last patient enrolled)
D: Change From Baseline in the Number of Bowel Movements (BMs) Per Day Averaged Over 12 Weeks (Baseline and 12 Weeks); Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Treatment Period (First dose of study drug to within 30 days of last dose of study drug in the Double-Blind Treatment Period (Up to 17.6 Weeks)); Number of Participants With TEAEs in the Open-Label Extension Period (First dose of study drug to within 30 days of last dose of study drug in the Open-Label Extension Period (Up to 54.3 Weeks))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome: Study Protocol for a Randomized, Placebo-controlled Trial
Brief Summary: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) affects many adult men worldwide. So far, available therapies offer little or no proven benefit to CP/CPPS. The investigators design and implement this study is to assess efficacy of acupuncture therapy performed in the CP/CPPS .


Options:
A: Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Crude Rate Approach) (Years 1-2, Years 3-4, and Overall (Years 1-4)); Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Modified Crude Rate Approach) (Years 1-2, Years 3-4, and Overall (Years 1-4)); Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Restricted Crude Rate Approach) (Years 1-2, Years 3-4, and Overall (Years 1-4))
B: Number consenting to join study out of eligible patients approached (6 months); Number of times therapists adhered to prescribed therapeutic protocol (12 weeks)
C: NIH-CPSI total score and change from baseline (baseline, week 1-8)
D: Six point drop in NIH-CPSI total Score

Answer: C