TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Randomized, Double-Blind, Multi-Center Trial of Low Dose Vasopressin Versus Placebo in Traumatic Shock Resuscitation
Brief Summary: Hypothesis: We hypothesize that resuscitation regimens which minimize the total volume of resuscitation fluid, while restoring organ perfusion, will lead to lower morbidity and mortality in critically ill patients following trauma.


Options:
A: Hospital Mortality (prior to discharge or 60 days, whichever comes first)
B: The Primary Endpoint of This Study Will be Day 30 Mortality. (30 days)
C: Systemic hemodynamic and Microcirculatory flow index of small and medium vessels (MFI) (over a period of 6 hrs from the time of randomization); Oxygen transport variables (over a period of 6 from the time of randomization)
D: Standing Dose of Norepinephrine Which is Required to Maintain a Mean Arterial Pressure (MAP) of 65 mmHg - Hour 1 (1 hour after initiation of angiotensin II (ATII)); Standing Dose of Norepinephrine Which is Required to Maintain a MAP of 65 mmHg - Hour 2 (2 hours after initiation of ATII)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase IIIb, Double Blind, Randomised, Placebo-Controlled, Multi-Country/Centre, Study to Assess Safety, Reactogenicity & Immunogenicity of 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Pre-Term Infants
Brief Summary: This study is planned to evaluate the safety (in terms of occurrence of any serious adverse events), reactogenicity (any side effects) and immunogenicity (ability of the vaccine to develop antibodies that fight infection) of the HRV vaccine when used in pre-term infants aged between 6 and 14 weeks at the time of the first dose in Portugal, France and Poland and in pre-term infants aged between 6 and 12 weeks at the time of first dose in Spain. The study will be performed in four European countries (France, Poland, Spain, and Portugal). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Options:
A: Occurrence of Severe Clinical Rotavirus Disease Caused by Any Rotavirus Serotype More Than 14 Days Following the Third Dose (At least 14 days following the third vaccination)
B: Number of Subjects Reporting Any Serious Adverse Events (SAEs). (From Day 0 up to 1 month after Dose 2 of Rotarix vaccine/Placebo)
C: Mortality; Hospitalisations
D: Occurrence of severe RV GE caused by the wild RV strains from 2 weeks after Dose 2 until two years of age. Occurrence of definite IS cases within 31 days (Day 0 -Day 30) after each HRV vaccination dose.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase IIIb, Double Blind, Randomised, Placebo-Controlled, Multi-Country/Centre, Study to Assess Safety, Reactogenicity & Immunogenicity of 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Pre-Term Infants
Brief Summary: This study is planned to evaluate the safety (in terms of occurrence of any serious adverse events), reactogenicity (any side effects) and immunogenicity (ability of the vaccine to develop antibodies that fight infection) of the HRV vaccine when used in pre-term infants aged between 6 and 14 weeks at the time of the first dose in Portugal, France and Poland and in pre-term infants aged between 6 and 12 weeks at the time of first dose in Spain. The study will be performed in four European countries (France, Poland, Spain, and Portugal). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Options:
A: Percentage of subjects with vaccine take (At 2 months post-Dose 2)
B: Number of Subjects Reporting Any Serious Adverse Events (SAEs). (From Day 0 up to 1 month after Dose 2 of Rotarix vaccine/Placebo)
C: Number of Subjects Reporting Grade "2" or Grade "3" Fever, Vomiting or Diarrhea (Within the 15-day solicited follow-up period after any dose)
D: Occurrence of RV GE

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase IIIb, Double Blind, Randomised, Placebo-Controlled, Multi-Country/Centre, Study to Assess Safety, Reactogenicity & Immunogenicity of 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Pre-Term Infants
Brief Summary: This study is planned to evaluate the safety (in terms of occurrence of any serious adverse events), reactogenicity (any side effects) and immunogenicity (ability of the vaccine to develop antibodies that fight infection) of the HRV vaccine when used in pre-term infants aged between 6 and 14 weeks at the time of the first dose in Portugal, France and Poland and in pre-term infants aged between 6 and 12 weeks at the time of first dose in Spain. The study will be performed in four European countries (France, Poland, Spain, and Portugal). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Options:
A: Number of Subjects Reporting Any Serious Adverse Events (SAEs). (From Day 0 up to 1 month after Dose 2 of Rotarix vaccine/Placebo)
B: Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild Type (WT) Strains (From Month 1 ½ to Month 21)
C: Number of Seroconverted Subjects for Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody. (2 months post-Dose 2 (at study Month 4))
D: Safety of Rotavin-M1 vaccine in healthy adult volunteers (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2 Study of Telaprevir (VX-950) in Combination With Peginterferon Alfa-2a (Pegasys®), and Ribavirin (Copegus®) in Subjects With Genotype 1 Hepatitis C Who Have Not Achieved Sustained Viral Response With a Prior Course of Interferon Based Therapy
Brief Summary: The PROVE3 trial is a partially double blinded, randomized, Phase 2 research study of an investigational drug, Telaprevir (VX-950) or Placebo, with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a, Pegasys®), and Ribavirin (RBV, Copegus®) in people with genotype 1 hepatitis C who have not achieved a Sustained Viral Response (SVR) with a previous treatment of interferon therapy.


Options:
A: Percentage of Participants With Virologic Response at Week 12 (End of treatment (EOT) (up to Week 48))
B: Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing (24 weeks after the completion of study drug dosing (up to Week 72))
C: Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24) (Post-treatment Week 24); Percentage of Participants Who Experienced Adverse Events (Baseline (Day 1) to post-treatment Day 30)
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: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2 Study of Telaprevir (VX-950) in Combination With Peginterferon Alfa-2a (Pegasys®), and Ribavirin (Copegus®) in Subjects With Genotype 1 Hepatitis C Who Have Not Achieved Sustained Viral Response With a Prior Course of Interferon Based Therapy
Brief Summary: The PROVE3 trial is a partially double blinded, randomized, Phase 2 research study of an investigational drug, Telaprevir (VX-950) or Placebo, with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a, Pegasys®), and Ribavirin (RBV, Copegus®) in people with genotype 1 hepatitis C who have not achieved a Sustained Viral Response (SVR) with a previous treatment of interferon therapy.


Options:
A: Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing (24 weeks after the completion of study drug dosing (up to Week 72))
B: HCV RNA (At each clinic visit, throughout study); Adverse events, laboratory parameters, vital signs (At each clinic visit, throughout study)
C: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Study Drug (SVR12) (Posttreatment Week 12); Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug (Up to 24 weeks)
D: Number of Participants With Virologic Response Defined as >= 3 Log Drop in Viral Load From Baseline at Day 28 With no Evidence of Virologic Rebound During These 28 Days. Virologic Rebound is Defined as >= 1 Log Increase in Viral Load From Nadir. (Baseline and 4 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-label, Multi-center, Phase II/III Study on Treatment With ABR-217620/Naptumomab Estafenatox Combined With IFN-alpha vs. IFN-alpha Alone in Patients With Advanced Renal Cell Carcinoma.
Brief Summary: The drug ABR-217620/naptumomab estafenatox is a fusion of two proteins, one that recognizes tumor cells and one that triggers an attack on the tumor cells by activating some white blood cells belonging to the body's normal immune system. This results in an accumulation of white blood cells in the cancer that can fight the cancer. This study will compare the safety and effectiveness (assessed by tumor status and survival) of ABR-217620/naptumomab estafenatox when given with standard therapy IFN-alpha to IFN-alpha alone in patients with advanced renal cell carcinoma (RCC).


Options:
A: Time to death (every 12 weeks, including after a maximum of 18 months of study treatment)
B: Progression-Free Survival (PFS): Independent-Assessment (Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012))
C: progression-free rate (at 48 weeks post-treatment)
D: Progression Free Survival (PFS): First-Line Participants (Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)); Progression Free Survival (PFS): Second-Line Participants (Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Strategies for Transfusion of Platelets (SToP) [Formerly Titled "Evaluation of the Hemostatic Efficacy and Platelet Utilization Rates of Low Versus Standard Dose Platelet Therapy"]
Brief Summary: To evaluate the hemostatic efficacy of a low dose platelet transfusion strategy compared to a standard dose platelet transfusion strategy.


Options:
A: Daily hemostatic assessments will be conducted to determine presence of WHO Grade 2 bleeding or greater.
B: At Least One Day With Grade 2 or Higher Bleeding (From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first))
C: Bleeding within 24 hours after cvc application; other complications within the first 24 hours
D: reduction in numbers of platelet transfusion by 25 % in the experimental arm (therapeutic transfusion strategy)compared with the standard arm (prophylactic transfusion strategy) (2010)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Strategies for Transfusion of Platelets (SToP) [Formerly Titled "Evaluation of the Hemostatic Efficacy and Platelet Utilization Rates of Low Versus Standard Dose Platelet Therapy"]
Brief Summary: To evaluate the hemostatic efficacy of a low dose platelet transfusion strategy compared to a standard dose platelet transfusion strategy.


Options:
A: Daily hemostatic assessments will be conducted to determine presence of WHO Grade 2 bleeding or greater.
B: Maximum Tolerated Dose (MTD) of Eltrombopag (1.5 years)
C: Part A: Number of Participants With Adverse Events (Treatment period (4 weeks) plus treatment extension (1 year)); Part B: Number of Participants With Adverse Events (Treatment period (8 weeks) plus treatment extension (1 year))
D: At Least One Day With Grade 2 or Higher Bleeding (From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Strategies for Transfusion of Platelets (SToP) [Formerly Titled "Evaluation of the Hemostatic Efficacy and Platelet Utilization Rates of Low Versus Standard Dose Platelet Therapy"]
Brief Summary: To evaluate the hemostatic efficacy of a low dose platelet transfusion strategy compared to a standard dose platelet transfusion strategy.


Options:
A: reduction in numbers of platelet transfusion by 25 % in the experimental arm (therapeutic transfusion strategy)compared with the standard arm (prophylactic transfusion strategy) (2010)
B: Bleeding within 24 hours after cvc application; other complications within the first 24 hours
C: At Least One Day With Grade 2 or Higher Bleeding (From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first))
D: Daily hemostatic assessments will be conducted to determine presence of WHO Grade 2 bleeding or greater.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Strategies for Transfusion of Platelets (SToP) [Formerly Titled "Evaluation of the Hemostatic Efficacy and Platelet Utilization Rates of Low Versus Standard Dose Platelet Therapy"]
Brief Summary: To evaluate the hemostatic efficacy of a low dose platelet transfusion strategy compared to a standard dose platelet transfusion strategy.


Options:
A: reduction in numbers of platelet transfusion by 25 % in the experimental arm (therapeutic transfusion strategy)compared with the standard arm (prophylactic transfusion strategy) (2010)
B: Daily hemostatic assessments will be conducted to determine presence of WHO Grade 2 bleeding or greater.
C: At Least One Day With Grade 2 or Higher Bleeding (From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first))
D: Bleeding within 24 hours after cvc application; other complications within the first 24 hours

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation With Methotrexate and Adalimumab Combination Therapy in Patients With Early Rheumatoid Arthritis (OPTIMA)
Brief Summary: This study compared the safety and efficacy of combination therapy with adalimumab plus methotrexate (MTX) to that of MTX monotherapy (i.e., placebo plus MTX) in subjects with early rheumatoid arthritis (RA).


Options:
A: Number of Subjects With Low Disease Activity (DAS28 Less Than 3.2) and No Radiographic Progression From Baseline (Change in mTSS Less Than or Equal to 0.5) at Week 78, Arm 2 vs. Arm 4 (Week 78)
B: Percentage of Subjects With Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) <= 3.2 at Week 104 in RA0055 Period 2 Without Flaring (Week 104 in RA0055 Period 2)
C: Percentage of Participant Who Were Non-Failures (Week 48)
D: Percentage of Participants Who Remained in Low Disease Activity (LDA) (Disease Activity Score in 28 Joints-erythrocyte Sedimentation Rate [DAS28-ESR] <3.2) at Week 52. (Baseline and Week 52)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation With Methotrexate and Adalimumab Combination Therapy in Patients With Early Rheumatoid Arthritis (OPTIMA)
Brief Summary: This study compared the safety and efficacy of combination therapy with adalimumab plus methotrexate (MTX) to that of MTX monotherapy (i.e., placebo plus MTX) in subjects with early rheumatoid arthritis (RA).


Options:
A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 (Month 6); Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 (Baseline, Month 3); Percentage of Participants Achieving 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)
B: Percentage of Participants With American College of Rheumatology-ACR20 Response (Baseline, Week 24); Change From Baseline in Modified Total Sharp-Genant Score at Week 52 (Baseline, Week 52); Change in Physical Function as Measured by the Area Under the Curve (AUC) for the Change From Baseline in the Health Assessment Questionnaire (HAQ) Disability Index at Week 52 (Baseline to Week 52); Change From Baseline in the Modified Total Sharp-Genant Score at Week 104 (Baseline, Week 104); Change in Physical Function as Measured by the Area Under the Curve for the Change From Baseline in the Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 104 (Baseline to Week 104)
C: Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response at Week 24 (Week 24)
D: Number of Subjects With Low Disease Activity (DAS28 Less Than 3.2) and No Radiographic Progression From Baseline (Change in mTSS Less Than or Equal to 0.5) at Week 78, Arm 2 vs. Arm 4 (Week 78)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation With Methotrexate and Adalimumab Combination Therapy in Patients With Early Rheumatoid Arthritis (OPTIMA)
Brief Summary: This study compared the safety and efficacy of combination therapy with adalimumab plus methotrexate (MTX) to that of MTX monotherapy (i.e., placebo plus MTX) in subjects with early rheumatoid arthritis (RA).


Options:
A: Achievement of a clinical response (according to the ACR criteria) at the 30-week follow-up visit. (30-week follow-up visit.)
B: 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))
C: Number of Subjects With Low Disease Activity (DAS28 Less Than 3.2) and No Radiographic Progression From Baseline (Change in mTSS Less Than or Equal to 0.5) at Week 78, Arm 2 vs. Arm 4 (Week 78)
D: Percentage of patients with ACR 20 response (Week 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation With Methotrexate and Adalimumab Combination Therapy in Patients With Early Rheumatoid Arthritis (OPTIMA)
Brief Summary: This study compared the safety and efficacy of combination therapy with adalimumab plus methotrexate (MTX) to that of MTX monotherapy (i.e., placebo plus MTX) in subjects with early rheumatoid arthritis (RA).


Options:
A: Change From Baseline in Modified Total Sharp X-Ray Score at Week 26 (Baseline, Week 26)
B: The Number of Participants Achieving Remission As Measured by a Disease Activity Score for 28 Joints (DAS 28) < 2.6. (12 months); Year 1 Participants Having an Annualized Modified Total Sharp Score (mTSS) < 0.5. (12 months)
C: EULAR individual response (12 months)
D: Number of Subjects With Low Disease Activity (DAS28 Less Than 3.2) and No Radiographic Progression From Baseline (Change in mTSS Less Than or Equal to 0.5) at Week 78, Arm 2 vs. Arm 4 (Week 78)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation With Methotrexate and Adalimumab Combination Therapy in Patients With Early Rheumatoid Arthritis (OPTIMA)
Brief Summary: This study compared the safety and efficacy of combination therapy with adalimumab plus methotrexate (MTX) to that of MTX monotherapy (i.e., placebo plus MTX) in subjects with early rheumatoid arthritis (RA).


Options:
A: Number of Subjects With Low Disease Activity (DAS28 Less Than 3.2) and No Radiographic Progression From Baseline (Change in mTSS Less Than or Equal to 0.5) at Week 78, Arm 2 vs. Arm 4 (Week 78)
B: Percentage of Participants With American College of Rheumatology-ACR20 Response (Baseline, Week 24); Change From Baseline in Modified Total Sharp-Genant Score at Week 52 (Baseline, Week 52); Change in Physical Function as Measured by the Area Under the Curve (AUC) for the Change From Baseline in the Health Assessment Questionnaire (HAQ) Disability Index at Week 52 (Baseline to Week 52); Change From Baseline in the Modified Total Sharp-Genant Score at Week 104 (Baseline, Week 104); Change in Physical Function as Measured by the Area Under the Curve for the Change From Baseline in the Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 104 (Baseline to Week 104)
C: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 (Month 6); Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3 (Baseline, Month 3); Percentage of Participants 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)
D: American College of Rheumatology 20% (ACR20) Response at Week 12 (Baseline, Week 12)

Answer: A