TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity of GlaxoSmithKline Biologicals' MMRV Vaccine (208136) vs. ProQuad®, When Coadministered With Hepatitis A and Pneumococcal Conjugate Vaccines to Children 12-14 Months of Age.
Brief Summary: The purpose of this observer blinded study is to provide information on vaccine immunogenicity and reactogenicity in comparison with the US standard of care (ProQuad®) when administered with Hepatitis A vaccine and Pneumococcal vaccine.


Options:
A: Frequencies of Glycoprotein E (gE)-Specific Cluster of Differentiation 4 (CD4) / CD8 T Cells With at Least Two Antigen-specific Cytokines: Interferon Gamma (IFN-γ), Interleukin 2 (IL-2), Tumor Necrosis Factor Alpha (TNF-α), CD 40 Ligand (CD40L). (At Month 30 after the first vaccination.); Frequencies of Varicella Zoster Virus (VZV)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). (At Month 30 after the first vaccination); Frequencies of Glycoprotein E (gE)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). (At Month 42 after the first vaccination); Frequencies of Varicella Zoster Virus (VZV)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). (At Month 42 after the first vaccination)
B: Number of Subjects With Seroresponse for Antibodies to Varicella Virus (VZV) (At Day 42 after vaccination); Concentration of Antibodies to Varicella Virus (VZV) (At Day 42 after vaccination); Number of Subjects With Seroresponse for Antibodies to Mumps Virus (At Day 42 after vaccination); Number of Subjects With Seroresponse for Antibodies to Measles Virus (At Day 42 after vaccination); Number of Subjects With Seroresponse for Antibodies to Rubella Virus (At Day 42 after vaccination); Concentration of Antibodies to Hepatitis A Virus (HAV) (At Day 42 after vaccination); Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (At Day 42 after vaccination)
C: Frequency of Glycoprotein E (gE)-Specific Cluster of Differentiation (CD4) T-cells Expressing at Least Two Different Activation Markers (One month after the second vaccination (Month 3)); Frequency Odds Ratio of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers (One month after the second vaccination (Month 3)); Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers (One month after the second vaccination (Month 3))
D: Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies Greater Than or Equal to (≥) the Cut-off Value. (At 42-56 days after the first dose of study vaccine (Week 6))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity and Safety Study of GSK Biologicals' HPV Vaccine (GSK-580299) Co-administered With a Commercially Available Vaccine in Healthy Female Adolescents
Brief Summary: Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical cancer, and so HPV vaccination could complement the existing pre-adolescent/adolescent vaccination programs. Therefore, this Phase IIIb study is designed to evaluate the safety and immunogenicity of co-administering a commercially available vaccine with GSK Biologicals' HPV-16/18 L1 AS04 (Cervarix ®) vaccine as compared to the administration of either vaccine alone. This Protocol Posting has been updated in order to comply with the FDA AA, Sept 2007.


Options:
A: Number of Subjects Seroconverted for Anti-hepatitis A (Anti-HAV) Antibodies (At Month 7); Anti-Heptatis A (HAV) Antibody Titers. (At Month 7); Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies (At Month 7); Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies (At Month 7); Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers (At Month 7)
B: Number of Seroconverted Subjects for Anti-human Papillomavirus (HPV)-16 and 18 Antibodies (At Month 7); Geometric Mean Titers (GMTs) of Anti-HPV-16 and Anti-HPV-18 Antibodies (At Month 7)
C: Seroconversion rates to HPV-16 and HPV-18 as assessed by enzyme-linked immunosorbent assay (ELISA) (At Month 7)
D: Comparison of Antibody Response to HPV Type 16 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule. (25 months); Comparison of Antibody Response to HPV Type 18 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule. (25 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Long Term Study of Ambrisentan in Pulmonary Arterial Hypertension Subjects Having Completed AMB-320 (NCT00423748) or AMB-321 (NCT00423202)
Brief Summary: AMB-320/321-E was designed to provide long-term, controlled monitoring of pulmonary arterial hypertension (PAH) patients treated with ambrisentan (AMB) in order to properly define the adverse event profile associated with this endothelin receptor antagonist (ERA), including the incidence and severity of elevated serum liver function tests (LFTs). In addition, this study continued the efficacy assessments of the previous studies, examined long-term AMB treatment success, and compared long-term survival of subjects treated with AMB to the NIH registry of patients with PAH.


Options:
A: Exercise Capacity; Pulmonary artery systolic pressure
B: Frequently Reported (15% or More Overall) Adverse Events by Severity (Baseline to Week 295); Serum Aminotransferases Relative to the Upper Limit of the Normal Range (ULN) (Baseline to Week 295)
C: Digital Micro-vascular Flow (Baseline and 12 weeks)
D: Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Core (6 months); Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Extension (72 months); Change From Baseline of Six Minute Walk Test - Total Distance Walked at Different Time Periods (Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)); Change From Baseline of Six Minute Walk Test - Number of Stops at Different Time Periods (Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)); Change From Baseline of Six Minute Walk Test - Total Duration of Stops at Different Time Periods (Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Long Term Study of Ambrisentan in Pulmonary Arterial Hypertension Subjects Having Completed AMB-320 (NCT00423748) or AMB-321 (NCT00423202)
Brief Summary: AMB-320/321-E was designed to provide long-term, controlled monitoring of pulmonary arterial hypertension (PAH) patients treated with ambrisentan (AMB) in order to properly define the adverse event profile associated with this endothelin receptor antagonist (ERA), including the incidence and severity of elevated serum liver function tests (LFTs). In addition, this study continued the efficacy assessments of the previous studies, examined long-term AMB treatment success, and compared long-term survival of subjects treated with AMB to the NIH registry of patients with PAH.


Options:
A: Change From Baseline to Week 16 in Pulmonary Vascular Resistance (PVR) at Rest. (From baseline to Week 16)
B: Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Core (6 months); Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Extension (72 months); Change From Baseline of Six Minute Walk Test - Total Distance Walked at Different Time Periods (Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)); Change From Baseline of Six Minute Walk Test - Number of Stops at Different Time Periods (Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)); Change From Baseline of Six Minute Walk Test - Total Duration of Stops at Different Time Periods (Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24))
C: Change from Baseline to End of Study in 6MWT distance. A mean difference from placebo of at least 35 m is considered clinically relevant. (16 weeks)
D: Frequently Reported (15% or More Overall) Adverse Events by Severity (Baseline to Week 295); Serum Aminotransferases Relative to the Upper Limit of the Normal Range (ULN) (Baseline to Week 295)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Wiser Choices in Osteoporosis Trial: The OSTEOPOROSIS CHOICE Decision Aid to Support the Decision to Use or Not Use Bisphosphonates in Postmenopausal Women at Risk of Osteoporotic Fractures.
Brief Summary: To develop a decision aid to support the decision to use (or not use) bisphosphonates in postmenopausal women at risk for osteoporotic fractures, and to assess the impact of the decision aid on start and six month adherence to bisphosphonates.


Options:
A: Evidence of success of decision aid to providers and patients, which leads to improved knowledge, reduced decisional conflict and enhanced satisfaction with the decision, and enhanced adherence to medication. (Directly following intervention.)
B: Feasibility of Data Collection at Month 12 (Data collection occurred at month 12)
C: Decisional Conflict Scale (3 months)
D: Primary Outcomes(composite): i) decision aid development, and ii) decision aid evaluation. (Phase 1-2 (1- year))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Wiser Choices in Osteoporosis Trial: The OSTEOPOROSIS CHOICE Decision Aid to Support the Decision to Use or Not Use Bisphosphonates in Postmenopausal Women at Risk of Osteoporotic Fractures.
Brief Summary: To develop a decision aid to support the decision to use (or not use) bisphosphonates in postmenopausal women at risk for osteoporotic fractures, and to assess the impact of the decision aid on start and six month adherence to bisphosphonates.


Options:
A: Patient's satisfaction and confidence with the information given. (Within two weeks after receiving the information and after 3 months.)
B: Mean Patient-centered Communication in Advanced Cancer Score (3 years)
C: Evidence of success of decision aid to providers and patients, which leads to improved knowledge, reduced decisional conflict and enhanced satisfaction with the decision, and enhanced adherence to medication. (Directly following intervention.)
D: Decision Self Efficacy (post intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Preoperative Treatment With Mifepristone on Uterine Fibroids and Breast Tissue
Brief Summary: Uterine fibroids are a benign but common condition among women in reproductive age. It is one of the most common reasons for hysterectomy since it often causes bleeding problems sometimes leading to anemia. Several alternative treatment regimens have been investigated that could replace surgery. The antiprogesterone, mifepristone, is one of the most promising drugs that have been tested. In addition to the inhibiting effect on the growth of uterine fibroids antiprogestins have been proposed to have an antiproliferative effect on breast tissue.

The purpose of the present study is to evaluate the effect of mifepristone on the volume of uterine fibroids. The study will also address the effect of mifepristone on the breast tissue


Options:
A: Shrinkage of Fibroids - Size of Fibroids (3 months (baseline to end of treatment))
B: Myoma size (2004 to 2007)
C: Efficacy endpoints (From baseline to end of PGL4001 treatment (3months treatment) and to approximately 2 weeks after double blind treatment with progestin/placebo.); Number and proportion of subjects experiencing open label treatment-emergent adverse events (From baseline to end of PGL4001 treatment (3months treatment))
D: percentage of subjects in amennorrhoea at the end of each PGL4001 treatment course received (From baseline to end of each PGL4001 treatment (3months treatment))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Preoperative Treatment With Mifepristone on Uterine Fibroids and Breast Tissue
Brief Summary: Uterine fibroids are a benign but common condition among women in reproductive age. It is one of the most common reasons for hysterectomy since it often causes bleeding problems sometimes leading to anemia. Several alternative treatment regimens have been investigated that could replace surgery. The antiprogesterone, mifepristone, is one of the most promising drugs that have been tested. In addition to the inhibiting effect on the growth of uterine fibroids antiprogestins have been proposed to have an antiproliferative effect on breast tissue.

The purpose of the present study is to evaluate the effect of mifepristone on the volume of uterine fibroids. The study will also address the effect of mifepristone on the breast tissue


Options:
A: Volume of the uterine leiomyomata with 2,5mg vs 5 mg daily of mifepristone after 3 months of treatment (3 months)
B: Myoma size (2004 to 2007)
C: Percent change from baseline in uterine volume and volume of the largest fibroid. (Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6.); Duration of amenorrhea (Day 1 to 1st post treatment menses)
D: percentage of subjects in amennorrhoea at the end of each PGL4001 treatment course received (From baseline to end of each PGL4001 treatment (3months treatment))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Immediate Versus Delayed Cord Clamping in the Preterm Neonate
Brief Summary: To determine the short and long term effects of placental transfusion at birth by milking and delayed cord clamping of the umbilical cord in neonates born between 24 weeks 0 days and 34 weeks 0 days weeks' gestation.


Options:
A: Superior Vena Cava Flow (6 hours)
B: Hematologic status at 6 months of age; Iron status at 6 months of age
C: To determine the short and long term effects of placental transfusion at birth by milking and delayed cord clamping of the umbilical cord in neonates born between 24 weeks 0 days and 34 weeks 0 days weeks' gestation. (2 years)
D: Motor function (18-22 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Assessor-blind, Non-inferiority Study Comparing the Efficacy and Safety of Once-weekly Subcutaneous Biotinylated Idraparinux (SSR126517E) With Oral Adjusted-dose Warfarin in the Prevention of Stroke and Systemic Thromboembolic Events in Patients With Atrial Fibrillation
Brief Summary: The objective is to evaluate whether once weekly subcutaneous (SC) injection of idrabiotaparinux sodium (biotinylated idraparinux) is at least as efficient to prevent clots in brain and in the other organs than oral international normalized ratio (INR) adjusted-dose warfarin in patients with atrial fibrillation (AF).


Options:
A: Composite of all fatal or non-fatal strokes or non central nervous system (CNS) systemic embolic events (SE) (From randomization up to the end of the treatment period (minimum of 6 months))
B: major bleeding (up to 48 hours from last injection)
C: Symptomatic recurrent PE/DVT during the 6-month study treatment period.
D: Composite of all strokes and non-CNS systemic embolism.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Assessor-blind, Non-inferiority Study Comparing the Efficacy and Safety of Once-weekly Subcutaneous Biotinylated Idraparinux (SSR126517E) With Oral Adjusted-dose Warfarin in the Prevention of Stroke and Systemic Thromboembolic Events in Patients With Atrial Fibrillation
Brief Summary: The objective is to evaluate whether once weekly subcutaneous (SC) injection of idrabiotaparinux sodium (biotinylated idraparinux) is at least as efficient to prevent clots in brain and in the other organs than oral international normalized ratio (INR) adjusted-dose warfarin in patients with atrial fibrillation (AF).


Options:
A: Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE (12 months from time of randomization)
B: Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Superiority for Composite of Stroke and Systemic Embolic Events (SEE). (overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up)
C: Incidence of major and clinically relevant non-major bleeding events (Double-blind treatment period (variable, up to 16 months))
D: Composite of all fatal or non-fatal strokes or non central nervous system (CNS) systemic embolic events (SE) (From randomization up to the end of the treatment period (minimum of 6 months))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIa Randomized, Partially Blinded Trial of Telaprevir (VX-950) in Treatment-Naive Subjects With Chronic Genotype 4 Hepatitis C Infection
Brief Summary: The purpose of this study is to evaluate the activity and safety of telaprevir on Hepatitis C Virus (HCV) Genotype 4, alone or in combination with standard therapy, that is, pegylated-interferon-alfa-2a and ribavirin in treatment-naive (never been treated before with antiretroviral therapy) participants.


Options:
A: Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Day 15 (Baseline and Day 15)
B: Percentage of Participants Achieving RVR (Week 4); Number of Participants Experiencing an Adverse Event (AE) (Up to Day 42); Number of Participants Discontinuing From Study Therapy Due to AEs (Day 1 to Day 28)
C: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug (Up to 12 weeks)
D: Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12) (12 weeks after end of therapy (up to 30 weeks)); Percentage of Participants Experiencing at Least One Adverse Event (AE) During the Treatment Period and First 14 Follow-up Days (From Day 1 [post-dose] through 14 days following last dose of study drug (up to 20 weeks)); Percentage of Participants Discontinuing Study Therapy Due to an AE During the Treatment Period and First 14 Follow-up Days (From Day 1 [post-dose] through 14 days following last dose of study drug (up to 20 weeks))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIa Randomized, Partially Blinded Trial of Telaprevir (VX-950) in Treatment-Naive Subjects With Chronic Genotype 4 Hepatitis C Infection
Brief Summary: The purpose of this study is to evaluate the activity and safety of telaprevir on Hepatitis C Virus (HCV) Genotype 4, alone or in combination with standard therapy, that is, pegylated-interferon-alfa-2a and ribavirin in treatment-naive (never been treated before with antiretroviral therapy) participants.


Options:
A: Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Day 15 (Baseline and Day 15)
B: Sustained Virological Response 12 Weeks Post-treatment (SVR12) (12 weeks post treatment, up to 60 weeks)
C: Percentage of Participants With Sustained Virologic Response at Post Treatment Week 12 (SVR12) (Follow-up Week 12)
D: Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12 (A Weeks 4 and 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIb Open-label run-in Double-blind, Placebo Controlled, Randomized Study to Evaluate the Safety/Efficacy of Certolizumab Pegol Administered Concomitantly With Stable-dose Methotrexate in Patients With Active Rheumatoid Arthritis.
Brief Summary: During the run-in period, CZP will be administered at 400 mg (2 injections) at Wks 0, 2, and 4 and 200 mg with placebo (1 injection placebo, 1 injection CZP) at Wks 6, 8, 10, 12, 14 and 16. At Wk 18 patients will be grouped as responders or non-responders based on results of the ACR20 at Week 16.


Options:
A: Change in disease activity. (6 months)
B: Percentage of Subjects Without Baseline Protective Titers Achieving a ≥ 2-fold Titer Increase in ≥ 3 of 6 Pneumococcal Antigens (6B, 9V, 14, 18C, 19F, and 23F) at Week 6. (Baseline, End of single blind period (Week 6)); Percentage of Subjects Without Baseline Protective Titers Achieving a ≥ 4-fold Titer Increase in ≥ 2 of 3 Influenza Antigens (2009/2010 Composition) at Week 6. (Baseline, End of single blind period (Week 6))
C: American College of Rheumatology 20% (ACR20) Response at Week 12 (Baseline, Week 12)
D: Percentage of ACR20 (American College of Rheumatology 20% Improvement) Responders at Week 34 in Patients Randomized at Week 18 (Baseline, Week 34)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIb Open-label run-in Double-blind, Placebo Controlled, Randomized Study to Evaluate the Safety/Efficacy of Certolizumab Pegol Administered Concomitantly With Stable-dose Methotrexate in Patients With Active Rheumatoid Arthritis.
Brief Summary: During the run-in period, CZP will be administered at 400 mg (2 injections) at Wks 0, 2, and 4 and 200 mg with placebo (1 injection placebo, 1 injection CZP) at Wks 6, 8, 10, 12, 14 and 16. At Wk 18 patients will be grouped as responders or non-responders based on results of the ACR20 at Week 16.


Options:
A: Number of Subjects Experiencing Any Adverse Event (throughout entire study (61 +/- 28.9 weeks on average)); Number of Subjects Experiencing Serious Adverse Event (throughout entire study (61 +/- 28.9 weeks on average)); Number of Subjects Experiencing Any Infection (throughout entire study (61 +/- 28.9 weeks on average))
B: Change From Baseline in Adjusted Mean of American College of Rheumatology Response (ACR-N) Area Under Curve (AUC) Over 16 Weeks (16 weeks)
C: Percentage of ACR20 (American College of Rheumatology 20% Improvement) Responders at Week 34 in Patients Randomized at Week 18 (Baseline, Week 34)
D: American College of Rheumatology 20% (ACR20) Response at Week 12 (Baseline, Week 12)

Answer: C