TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Placebo Controlled, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) Compared to Placebo in Patients With Locally Advanced and/or Metastatic Renal Cell Carcinoma
Brief Summary: To evaluate efficacy and safety of pazopanib compared to placebo in patients with locally advanced and/ or metastatic renal cell carcinoma (RCC). Approximately 350-400 eligible patients will be stratified and randomized in a 2:1 ratio to receive either 800 mg pazopanib once daily or matching placebo. The study treatment will continue until patients experience disease progression, unacceptable toxicity or death. Primary objective of the study is to evaluate and compare the two treatment arms for progression-free survival. Principal secondary objective is to evaluate and compare the two treatment arms with respect to overall survival. Other objectives are overall response rate \[complete response (CR) + partial response (PR)\], rate of CR + PR + 6 months stable disease, and the incidence, severity and causality of adverse events and serious adverse events. Safety and efficacy assessments will be regularly performed on all patients. An Independent Data Monitoring Committee will be established to monitor safety during the course of the study and to evaluate interim efficacy data on overall survival.


Options:
A: 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))
B: Overall survival (2015 (estimated))
C: Immune-related Progression Free Survival (irPFS) at 20 Weeks in MSI Positive and Negative Colorectal Adenocarcinoma Participants Using Immune Related Response Criteria (irRC) During Stages 1 and 2 (20 weeks); Immune-related Objective Response Rate in MSI Positive and Negative Colorectal Adenocarcinoma Participants Using Immune Related Response Criteria (irRC) During Stages 1 and 2 (28 months); Immune-related Progression Free Survival (irPFS) at 20 Weeks in MSI Positive Non-colorectal Adenocarcinoma Participants Using Immune Related Response Criteria (irRC) During Stages 1 and 2 (20 weeks); Objective Response Rate in MSI Positive Solid Tumor Malignancies Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (28 months); Progression Free Survival (PFS) at 20 Weeks in MSI Positive Solid Tumor Malignancies Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (20 weeks)
D: Progression-free Survival (Randomization until progression (up to 2 years))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Placebo Controlled, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) Compared to Placebo in Patients With Locally Advanced and/or Metastatic Renal Cell Carcinoma
Brief Summary: To evaluate efficacy and safety of pazopanib compared to placebo in patients with locally advanced and/ or metastatic renal cell carcinoma (RCC). Approximately 350-400 eligible patients will be stratified and randomized in a 2:1 ratio to receive either 800 mg pazopanib once daily or matching placebo. The study treatment will continue until patients experience disease progression, unacceptable toxicity or death. Primary objective of the study is to evaluate and compare the two treatment arms for progression-free survival. Principal secondary objective is to evaluate and compare the two treatment arms with respect to overall survival. Other objectives are overall response rate \[complete response (CR) + partial response (PR)\], rate of CR + PR + 6 months stable disease, and the incidence, severity and causality of adverse events and serious adverse events. Safety and efficacy assessments will be regularly performed on all patients. An Independent Data Monitoring Committee will be established to monitor safety during the course of the study and to evaluate interim efficacy data on overall survival.


Options:
A: Progression Free Survival (PFS) (From randomization to disease progression or death (up to approximately 2 years))
B: Progression Free Survival First-Line (PFS 1-L) (based on radiological assessments every 3 months until disease progression, start of another antineoplastic therapy or for any other reason up to 35 months)
C: Progression-free Survival (Randomization until progression (up to 2 years))
D: Progression-free Survival (PFS) of Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab (Time from randomization to the date of radiological progressive disease as per independent central review, death from any cause, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cutoff date.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Neoadjuvant Chemotherapy and Extrapleural Pneumonectomy of Malignant Pleural Mesothelioma (MPM) With or Without Hemithoracic Radiotherapy. A Randomized Multicenter Phase II Trial
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This randomized phase II trial is studying how well giving pemetrexed disodium together with cisplatin followed by surgery with or without radiation therapy works in treating patients with malignant pleural mesothelioma.


Options:
A: Feasibility in terms of 90-day progression-free survival
B: % of patients with controled disease (responder and stable patients) at 6 months (3-month)
C: Objective tumor response by modified Response Evaluation Criteria in Solid Tumor (RECIST) (Weeks 24)
D: Complete macroscopic resection (part 1) (After surgery (15 weeks after trial registration)); Loco-regional relapse-free survival (part 2) (From surgery until the first occurrence of loco-regional relapse)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Neoadjuvant Chemotherapy and Extrapleural Pneumonectomy of Malignant Pleural Mesothelioma (MPM) With or Without Hemithoracic Radiotherapy. A Randomized Multicenter Phase II Trial
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This randomized phase II trial is studying how well giving pemetrexed disodium together with cisplatin followed by surgery with or without radiation therapy works in treating patients with malignant pleural mesothelioma.


Options:
A: Overall Survival (OS) (approximately 3 years 8 months (From Study start date [27 May 2011] up to final analysis data cut-off [05 January 2015])
B: Overall Survival (OS) (From date of treatment start until date of death from any cause, up to 5 years 5 months)
C: Complete macroscopic resection (part 1) (After surgery (15 weeks after trial registration)); Loco-regional relapse-free survival (part 2) (From surgery until the first occurrence of loco-regional relapse)
D: Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 12 (Part B) (Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Assess the Immunogenicity of 3 Doses of Pediarix®, Prevnar® & ActHIB® Given to Healthy Infants When Administered With GSK Biologicals' 2 Dose Oral Live Attenuated Human Rotavirus Vaccine Given During the Same Vaccination Visit or Separately
Brief Summary: The aim of this this study is to confirm absence of immune interference between HRV vaccine and routine infant vaccinations currently in use in the USA.


Options:
A: Demonstrate that coadministration with HRV vaccine does not impair the immune response to all antigens contained in each of the routine infant vaccines.
B: Occurrence of RV GE
C: occurrence of Severe Rotavirus Gastroenteritis (Up to 2 years of age of participants)
D: Presence of Rotavirus Vaccine Strain in Any Stool Sample From Twin Receiving Placebo. (On the day of each vaccine/placebo dose, then three times weekly for 6 consecutive weeks starting after each vaccine/placebo dose and on the day of Visit 3.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Assess the Immunogenicity of 3 Doses of Pediarix®, Prevnar® & ActHIB® Given to Healthy Infants When Administered With GSK Biologicals' 2 Dose Oral Live Attenuated Human Rotavirus Vaccine Given During the Same Vaccination Visit or Separately
Brief Summary: The aim of this this study is to confirm absence of immune interference between HRV vaccine and routine infant vaccinations currently in use in the USA.


Options:
A: occurrence of Severe Rotavirus Gastroenteritis (Up to 2 years of age of participants)
B: To assess immunogenicity of a new rotavirus vaccine Rotavin-M1 in terms of anti-rotavirus IgA antibody seroconversion 1 month after complete the vaccination schedule (up to 7 months)
C: Demonstrate that coadministration with HRV vaccine does not impair the immune response to all antigens contained in each of the routine infant vaccines.
D: Presence of Rotavirus Vaccine Strain in Any Stool Sample From Twin Receiving Placebo. (On the day of each vaccine/placebo dose, then three times weekly for 6 consecutive weeks starting after each vaccine/placebo dose and on the day of Visit 3.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Assess the Immunogenicity of 3 Doses of Pediarix®, Prevnar® & ActHIB® Given to Healthy Infants When Administered With GSK Biologicals' 2 Dose Oral Live Attenuated Human Rotavirus Vaccine Given During the Same Vaccination Visit or Separately
Brief Summary: The aim of this this study is to confirm absence of immune interference between HRV vaccine and routine infant vaccinations currently in use in the USA.


Options:
A: Seroprotection for each polio serotype 1 month after the 3rd dose.
B: Demonstrate that coadministration with HRV vaccine does not impair the immune response to all antigens contained in each of the routine infant vaccines.
C: Immunogenicity (7 months)
D: Number of Subjects Reporting Grade "2" or Grade "3" Fever, Vomiting or Diarrhea (Within the 15-day solicited follow-up period after any dose)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Masked, Placebo Controlled Study to Assess the Safety and Efficacy of Darbepoetin Alfa Administered to Preterm Infants
Brief Summary: Infants born prematurely do not increase production of the primary red cell growth factor, erythropoietin (Epo), and often develop an anemia called the "anemia of prematurity." The anemia of prematurity is the most common anemia seen in neonates, and is due to a failure of Epo production. Human recombinant Epo (rHuEpo), given three to five times a week, is successful in treating the anemia of prematurity. A slightly modified, long-acting version of rHuEpo, called darbepoetin alfa (darbepoetin), is now available and has proven effective in increasing hematocrit (red blood cell levels) in adults. In addition to its red cell stimulating properties, recent evidence has shown that rHuEpo is protective in the developing or injured brain. We have designed a randomized, masked, placebo-controlled study to determine the safety and short and long term efficacy of darbepoetin. At this time, darbepoetin has been studied primarily in adults and pediatric patients, but there is evidence from pilot studies that darbepoetin would be useful in the neonatal setting as well. It also may well improve neurodevelopmental outcomes in preterm neonates. We hypothesize that: 1. The administration of darbepoetin to preterm infants 500 to 1,250 grams birth weight will result in increased reticulocyte counts and decreased transfusions compared to placebo; and 2. The administration of darbepoetin will be associated with an increased mental developmental index at 18-22 months compared to placebo.


Options:
A: Full Scale IQ, Performance IQ, Verbal IQ, Executive Function (42-48 months and 66-72 months)
B: Death or Neurodevelopment Impairment (18-22 Months Corrected Age)
C: Mental developmental index (Bayley II) and motor, visual and hearing impairment (at age of 24 months corrected for prematurity.)
D: Number of Transfusions During Hospitalization (From birth to 36 weeks gestational age); Composite Cognitive Score at 18-22 Months Corrected Age (18-22 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Masked, Placebo Controlled Study to Assess the Safety and Efficacy of Darbepoetin Alfa Administered to Preterm Infants
Brief Summary: Infants born prematurely do not increase production of the primary red cell growth factor, erythropoietin (Epo), and often develop an anemia called the "anemia of prematurity." The anemia of prematurity is the most common anemia seen in neonates, and is due to a failure of Epo production. Human recombinant Epo (rHuEpo), given three to five times a week, is successful in treating the anemia of prematurity. A slightly modified, long-acting version of rHuEpo, called darbepoetin alfa (darbepoetin), is now available and has proven effective in increasing hematocrit (red blood cell levels) in adults. In addition to its red cell stimulating properties, recent evidence has shown that rHuEpo is protective in the developing or injured brain. We have designed a randomized, masked, placebo-controlled study to determine the safety and short and long term efficacy of darbepoetin. At this time, darbepoetin has been studied primarily in adults and pediatric patients, but there is evidence from pilot studies that darbepoetin would be useful in the neonatal setting as well. It also may well improve neurodevelopmental outcomes in preterm neonates. We hypothesize that: 1. The administration of darbepoetin to preterm infants 500 to 1,250 grams birth weight will result in increased reticulocyte counts and decreased transfusions compared to placebo; and 2. The administration of darbepoetin will be associated with an increased mental developmental index at 18-22 months compared to placebo.


Options:
A: Full Scale IQ, Performance IQ, Verbal IQ, Executive Function (42-48 months and 66-72 months)
B: Number of Transfusions During Hospitalization (From birth to 36 weeks gestational age); Composite Cognitive Score at 18-22 Months Corrected Age (18-22 months)
C: Mental developmental index (Bayley II) and motor, visual and hearing impairment (at age of 24 months corrected for prematurity.)
D: The times taken to establish quarter, half, three quarters, and full enteral feeding after the drug treatment (at least 150ml/kg/day). (one month); Time to stop parentral nutrition (one month); Day of onset of weight gain (one month); Duration of hospitalization (2 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double-Blind, Multi-Center, Placebo-Controlled, Parallel-Group, Forced Dose Titration, Safety and Efficacy Study of NRP104 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)
Brief Summary: The purpose of this study is to evaluate the safety and effectiveness of NRP104 administered as a daily morning dose (30, 50, and 70mg/day) compared to placebo in adults (18-55 years of age inclusive) diagnosed with moderate to severe Attention Deficit Hyperactivity Disorder (ADHD).


Options:
A: Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Counts (study endpoint- end of period II (between subjects trial)); Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Percentages (study endpoint- end of period II (between subjects trial))
B: Change score from baseline of the ADHD-RS (4 weeks)
C: Attention Deficit Hyperactivity Disorder- Rating Scale (ADHS-RS) (12 weeks)
D: Clinician-administered ADHD-rating scale (ADHD-RS) performed using adult DSM-IV prompts (weekly over a period of 4 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Well Being of Obstetric Patients on Minimal Blood Transfusions
Brief Summary: Postpartum haemorrhage (PPH) is one of the top five causes of maternal mortality in developed and developing countries. The most important treatment of PPH is red blood cell (RBC) transfusion. The decision whether to prescribe RBC transfusion is mostly based on postpartum haemoglobin (Hb) values. RBC transfusion should be aimed to reduce morbidity and especially to improve Health Related Quality of Life (HRQoL). The goal of the WOMB study is to assess the effect of RBC transfusion on HRQoL and to confirm the role of HRQoL in deciding whether RBC transfusion is necessary.


Options:
A: Timed Up and Go-test (TUG)in seconds. (30 days)
B: Methodology of the pilot study (up to 30 days)
C: Randomization Rate (12 months)
D: Physical Fatigue (on day 3 postpartum)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Well Being of Obstetric Patients on Minimal Blood Transfusions
Brief Summary: Postpartum haemorrhage (PPH) is one of the top five causes of maternal mortality in developed and developing countries. The most important treatment of PPH is red blood cell (RBC) transfusion. The decision whether to prescribe RBC transfusion is mostly based on postpartum haemoglobin (Hb) values. RBC transfusion should be aimed to reduce morbidity and especially to improve Health Related Quality of Life (HRQoL). The goal of the WOMB study is to assess the effect of RBC transfusion on HRQoL and to confirm the role of HRQoL in deciding whether RBC transfusion is necessary.


Options:
A: Physical Fatigue (on day 3 postpartum)
B: Number of Subjects Who Achieved 'Success' Meaning a ≥ 2.0 Increase in Hemoglobin (anytime between baseline and the end of study or time to intervention)
C: Physical fatigue (From exposure to 12 weeks post-exposure)
D: Mortality at the 45th day (45 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Well Being of Obstetric Patients on Minimal Blood Transfusions
Brief Summary: Postpartum haemorrhage (PPH) is one of the top five causes of maternal mortality in developed and developing countries. The most important treatment of PPH is red blood cell (RBC) transfusion. The decision whether to prescribe RBC transfusion is mostly based on postpartum haemoglobin (Hb) values. RBC transfusion should be aimed to reduce morbidity and especially to improve Health Related Quality of Life (HRQoL). The goal of the WOMB study is to assess the effect of RBC transfusion on HRQoL and to confirm the role of HRQoL in deciding whether RBC transfusion is necessary.


Options:
A: Hemoglobin difference (14 days)
B: Myocardial Injury (Upto 60 days)
C: Physical Fatigue (on day 3 postpartum)
D: Number of Units of Packed Red Blood Cell Transfused (duration of the protocol, an average of 15 days); Percentage of Transfused Patients in Each Group (duration of the protocol, an average of 15 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Well Being of Obstetric Patients on Minimal Blood Transfusions
Brief Summary: Postpartum haemorrhage (PPH) is one of the top five causes of maternal mortality in developed and developing countries. The most important treatment of PPH is red blood cell (RBC) transfusion. The decision whether to prescribe RBC transfusion is mostly based on postpartum haemoglobin (Hb) values. RBC transfusion should be aimed to reduce morbidity and especially to improve Health Related Quality of Life (HRQoL). The goal of the WOMB study is to assess the effect of RBC transfusion on HRQoL and to confirm the role of HRQoL in deciding whether RBC transfusion is necessary.


Options:
A: Primary outcomes are related to feasibility and include recruitment rate, protocol adherence & difference in mean Hb concentration and RBC exposure between the 2 groups. (60 days following randomisation)
B: Tolerance of low transfusion threshold as assessed by the percentage of participants who crossed over from the low arm to the high arm. (60 days)
C: Physical Fatigue (on day 3 postpartum)
D: To compare mortality between groups 28 day after ICU admission (28 days after ICU admission)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Well Being of Obstetric Patients on Minimal Blood Transfusions
Brief Summary: Postpartum haemorrhage (PPH) is one of the top five causes of maternal mortality in developed and developing countries. The most important treatment of PPH is red blood cell (RBC) transfusion. The decision whether to prescribe RBC transfusion is mostly based on postpartum haemoglobin (Hb) values. RBC transfusion should be aimed to reduce morbidity and especially to improve Health Related Quality of Life (HRQoL). The goal of the WOMB study is to assess the effect of RBC transfusion on HRQoL and to confirm the role of HRQoL in deciding whether RBC transfusion is necessary.


Options:
A: Hemoglobin Concentration (In-hospital up to 30 days post randomization); Red Blood Cell Transfusion (In-hospital up to 30 days post randomization)
B: Core Temperature and blood loss (intraoperative)
C: Physical Fatigue (on day 3 postpartum)
D: Incidence of death or major neurodevelopmental impairment (24 months of age corrected for prematurity)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Well Being of Obstetric Patients on Minimal Blood Transfusions
Brief Summary: Postpartum haemorrhage (PPH) is one of the top five causes of maternal mortality in developed and developing countries. The most important treatment of PPH is red blood cell (RBC) transfusion. The decision whether to prescribe RBC transfusion is mostly based on postpartum haemoglobin (Hb) values. RBC transfusion should be aimed to reduce morbidity and especially to improve Health Related Quality of Life (HRQoL). The goal of the WOMB study is to assess the effect of RBC transfusion on HRQoL and to confirm the role of HRQoL in deciding whether RBC transfusion is necessary.


Options:
A: Physical Fatigue (on day 3 postpartum)
B: The primary purpose of this study is to compare clinical outcomes after cardiac surgery in patients submitted to different strategies of red blood cell transfusion (30 days after surgery)
C: Quality of Life (QOL)/Function based on the FACT-BMT scale (3 years)
D: Overall adherence to the transfusion strategies defined as adherence to the transfusion strategies in 90% of patients in more than 90% of their days in hospital. (Day of surgery through to hospital discharge.)

Answer: A