TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Venous and Arterial Thromboembolism, in Cancer Patients Undergoing Chemotherapy, With a Low Molecular Weight Heparin (Nadroparin Calcium). A Randomized, Placebo-controlled, Double-blind, Multicenter Phase III Study.
Brief Summary: In this phase III, multicenter study, 1200 patients with lung, breast, gastrointestinal (stomach, colon-rectum, pancreas), ovarian or head and neck cancer undergoing chemotherapy will be randomly assigned (at the beginning of cytotoxic therapy) in a 2:1 ratio and in double-blind conditions to a treatment with subcutaneous low molecular weight heparin (nadroparin calcium, one injection/day) or placebo for the overall duration of chemotherapy or up to a maximum of 4 months (+/- 10 days).


Options:
A: Significant increase of overall survival (At follow up 1 year after treatment)
B: Cumulative incidence of symptomatic venous and arterial thromboembolism, in patients with metastatic or locally advanced solid tumors undergoing chemotherapy (Events occurring during the four months of treatment plus 10 days)
C: Incidence of NCI CTC Toxicity III°/IV° and severe bleedings (minimum of 3 months)
D: Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or VTE-related Death (From randomization up to 3 days after last study drug injection); Time-to-first Occurrence of VTE or VTE-related Death (Cumulative Incidence Function) (From randomization up to 3 days after last study drug injection)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Venous and Arterial Thromboembolism, in Cancer Patients Undergoing Chemotherapy, With a Low Molecular Weight Heparin (Nadroparin Calcium). A Randomized, Placebo-controlled, Double-blind, Multicenter Phase III Study.
Brief Summary: In this phase III, multicenter study, 1200 patients with lung, breast, gastrointestinal (stomach, colon-rectum, pancreas), ovarian or head and neck cancer undergoing chemotherapy will be randomly assigned (at the beginning of cytotoxic therapy) in a 2:1 ratio and in double-blind conditions to a treatment with subcutaneous low molecular weight heparin (nadroparin calcium, one injection/day) or placebo for the overall duration of chemotherapy or up to a maximum of 4 months (+/- 10 days).


Options:
A: Percentage of Patients With Venous Thromboembolisms (12 weeks); Percentage of Patients Who Experienced Clinically Significant Bleeding Events. (13 weeks)
B: Thromboembolic events (during study treatment)
C: Cumulative incidence of symptomatic venous and arterial thromboembolism, in patients with metastatic or locally advanced solid tumors undergoing chemotherapy (Events occurring during the four months of treatment plus 10 days)
D: DVT/TVE event rate (After 12 events and after 24 events or after 540 pts recruited)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Venous and Arterial Thromboembolism, in Cancer Patients Undergoing Chemotherapy, With a Low Molecular Weight Heparin (Nadroparin Calcium). A Randomized, Placebo-controlled, Double-blind, Multicenter Phase III Study.
Brief Summary: In this phase III, multicenter study, 1200 patients with lung, breast, gastrointestinal (stomach, colon-rectum, pancreas), ovarian or head and neck cancer undergoing chemotherapy will be randomly assigned (at the beginning of cytotoxic therapy) in a 2:1 ratio and in double-blind conditions to a treatment with subcutaneous low molecular weight heparin (nadroparin calcium, one injection/day) or placebo for the overall duration of chemotherapy or up to a maximum of 4 months (+/- 10 days).


Options:
A: efficacy: progression-free survival in months (measurements of the size of the effect will be done using the Kaplan Meier method and the difference between the means of this time) (efficacy); safety: will be the incidence, during randomized treatment period (from day 1 to the last day of treatment + 7 days), of major bleedings. (safety)
B: Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or VTE-related Death (From randomization up to 3 days after last study drug injection); Time-to-first Occurrence of VTE or VTE-related Death (Cumulative Incidence Function) (From randomization up to 3 days after last study drug injection)
C: Percentage of Patients With Venous Thromboembolisms (12 weeks); Percentage of Patients Who Experienced Clinically Significant Bleeding Events. (13 weeks)
D: Cumulative incidence of symptomatic venous and arterial thromboembolism, in patients with metastatic or locally advanced solid tumors undergoing chemotherapy (Events occurring during the four months of treatment plus 10 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Venous and Arterial Thromboembolism, in Cancer Patients Undergoing Chemotherapy, With a Low Molecular Weight Heparin (Nadroparin Calcium). A Randomized, Placebo-controlled, Double-blind, Multicenter Phase III Study.
Brief Summary: In this phase III, multicenter study, 1200 patients with lung, breast, gastrointestinal (stomach, colon-rectum, pancreas), ovarian or head and neck cancer undergoing chemotherapy will be randomly assigned (at the beginning of cytotoxic therapy) in a 2:1 ratio and in double-blind conditions to a treatment with subcutaneous low molecular weight heparin (nadroparin calcium, one injection/day) or placebo for the overall duration of chemotherapy or up to a maximum of 4 months (+/- 10 days).


Options:
A: Cumulative incidence of symptomatic venous and arterial thromboembolism, in patients with metastatic or locally advanced solid tumors undergoing chemotherapy (Events occurring during the four months of treatment plus 10 days)
B: symptomatic objectively confirmed VTE, asymptomatic ultrasonography-confirmed DVT or VTE-related death (30 days)
C: efficacy: progression-free survival in months (measurements of the size of the effect will be done using the Kaplan Meier method and the difference between the means of this time) (efficacy); safety: will be the incidence, during randomized treatment period (from day 1 to the last day of treatment + 7 days), of major bleedings. (safety)
D: Incidence of venous thromboembolism reduction

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhanced Acute Medical Rehabilitation for Disablement
Brief Summary: This study will develop and test a new program of enhanced medical rehabilitation for elderly people who have had an acute disabling medical event and are admitted to a skilled nursing facility for post-acute rehabilitation.


Options:
A: Major Adverse Events related to treatment / residential status / immobilization (From surgery up to 1 year follow-up)
B: functional recovery (baseline, end of nursing home admission)
C: Self-rated degree of patient participation in rehabilitation (At discharge from in-patienten rehabilitation, on average 14 days)
D: Mobility (1, 4 and 12 months after surgery)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Preparation and Patient Education to Reduce Postpartum Depressive Symptoms
Brief Summary: This study will test an intervention that aims to prevent postpartum depression by providing new mothers with information on and resources for dealing with the disorder.


Options:
A: HIV-related transmission acts (18 months); Baby's health status (18 months); Maternal adherence to HIV-related and general health routines (18 months); Mental health (18 months); Social support (18 months)
B: Depressive symptoms (Measured at baseline); Depressive symptoms (Measured at 3 weeks); Depressive symptoms (Measured at 3 months); Depressive symptoms (Measured at 6 months)
C: Child cognitive development, behavior, and health (At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years); Child social-emotional development (At-risk sample: Up to 6 years; Not-at risk sample: Up to 1 year); Child depression (At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years)
D: Mothers' scores on a postnatal depression scale (baseline, and when the child is 3, 6 and 12 months old) (baseline, and when the child is 3, 6 and 12 months old); Parental competencies (when the child is 3, 12 and 18 months old) (when the child is 3, 12 and 18 months old); Child mental health (when the child is 18 and 24 months old) (when the child is 18 and 24 months old)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Acute Chest Syndrome by Transfusion Feasibility Study( PROACTIVE Feasibility Study)
Brief Summary: Acute chest syndrome (ACS) is similar to severe pneumonia and is a common cause of hospitalizations for people with sickle cell disease (SCD). Blood transfusions are one treatment option for ACS. High levels of an enzyme called secretory phospholipase A2 (sPLA2) may be present in people before they develop ACS. This study will determine how well sPLA2 levels can predict the onset of ACS and whether identifying high sPLA2 levels allows enough time to prevent ACS with blood transfusions. Results from this study will help to determine the feasibility of conducting a larger study that would further examine the use of sPLA2 levels and blood transfusions to prevent ACS in people with SCD.


Options:
A: Acute Chest Syndrome (Chest x-rays (CXR) were ordered for trial eligibility, as a result of clinical indications, or at discharge or 72 hours if no prior CXR.)
B: N/A
C: Number of Vaso-Occlusive Crisis (VOC) Events Per Participant Per Year (Rate of VOC) (Randomization through 24 Months)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Acute Chest Syndrome by Transfusion Feasibility Study( PROACTIVE Feasibility Study)
Brief Summary: Acute chest syndrome (ACS) is similar to severe pneumonia and is a common cause of hospitalizations for people with sickle cell disease (SCD). Blood transfusions are one treatment option for ACS. High levels of an enzyme called secretory phospholipase A2 (sPLA2) may be present in people before they develop ACS. This study will determine how well sPLA2 levels can predict the onset of ACS and whether identifying high sPLA2 levels allows enough time to prevent ACS with blood transfusions. Results from this study will help to determine the feasibility of conducting a larger study that would further examine the use of sPLA2 levels and blood transfusions to prevent ACS in people with SCD.


Options:
A: Acute Chest Syndrome (Chest x-rays (CXR) were ordered for trial eligibility, as a result of clinical indications, or at discharge or 72 hours if no prior CXR.)
B: Change from baseline to all assessed time points in 6MWT, in Borg dyspnea index, and in modified NYHA functional class.
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: 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)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Acute Chest Syndrome by Transfusion Feasibility Study( PROACTIVE Feasibility Study)
Brief Summary: Acute chest syndrome (ACS) is similar to severe pneumonia and is a common cause of hospitalizations for people with sickle cell disease (SCD). Blood transfusions are one treatment option for ACS. High levels of an enzyme called secretory phospholipase A2 (sPLA2) may be present in people before they develop ACS. This study will determine how well sPLA2 levels can predict the onset of ACS and whether identifying high sPLA2 levels allows enough time to prevent ACS with blood transfusions. Results from this study will help to determine the feasibility of conducting a larger study that would further examine the use of sPLA2 levels and blood transfusions to prevent ACS in people with SCD.


Options:
A: Recurrence of an Infarct, Defined as a Stroke or a New or Enlarged Silent Cerebral Infarct (From study entry to study exit)
B: Acute Chest Syndrome (Chest x-rays (CXR) were ordered for trial eligibility, as a result of clinical indications, or at discharge or 72 hours if no prior CXR.)
C: Treatment Differences of the Change in Qualitative Splenic Function From Baseline (Before initiation of treatment and at 2 years)
D: Difference in TCD Time-averaged Mean Velocity (TAMV) on the Index Side (Since the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 24 Months).)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Acute Chest Syndrome by Transfusion Feasibility Study( PROACTIVE Feasibility Study)
Brief Summary: Acute chest syndrome (ACS) is similar to severe pneumonia and is a common cause of hospitalizations for people with sickle cell disease (SCD). Blood transfusions are one treatment option for ACS. High levels of an enzyme called secretory phospholipase A2 (sPLA2) may be present in people before they develop ACS. This study will determine how well sPLA2 levels can predict the onset of ACS and whether identifying high sPLA2 levels allows enough time to prevent ACS with blood transfusions. Results from this study will help to determine the feasibility of conducting a larger study that would further examine the use of sPLA2 levels and blood transfusions to prevent ACS in people with SCD.


Options:
A: Acute Chest Syndrome (Chest x-rays (CXR) were ordered for trial eligibility, as a result of clinical indications, or at discharge or 72 hours if no prior CXR.)
B: 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)
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: Change from baseline to all assessed time points in 6MWT, in Borg dyspnea index, and in modified NYHA functional class.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Personalized and Targeted Feedback in the ACTION-Registry-GWTG
Brief Summary: This project is designed to examine the impact of tailored feedback on site performance.

The investigators' objective is to evaluate whether a 'personalized and targeted' feedback, education and performance improvement intervention has a greater impact on adherence to recommended guidelines than standard feedback.

The investigators hypothesize that a site-specific report with centrally identified targets for improvement paired with target specific interventions will enable sites to quickly identify and prioritize salient problem areas, have ready access to an analysis of factors that underlie problems, and formulate an effective action plan. The investigators also hypothesize that those hospitals randomized to receive intervention will be more likely to improve their overall performance, as well as their target specific performance, during the period of observation in direct response to activated QI processes.

Outcomes:

The primary outcome is improvement in the overall composite of all metrics eligible for intervention regardless of their selection as targets.

The secondary outcome is improvement in the composite of targeted metrics.

Outcomes will be assessed in all participating sites, and in among relevant performance subgroups (low performers, academic centers, full service, and among medication versus process metrics).


Options:
A: The proportion of subjects who fail to attend at least one outpatient adult endocrinology visit during the second year after transition to adult diabetes care. (30 months)
B: The primary outcome is improvement in the overall composite of all metrics eligible for intervention regardless of their selection as targets. (12 months)
C: Personal Health Partner (PHP) assessment with electronic health record (EHR) data exchange before pediatric primary care visits (2 week -1day before doctor's appointment and 1 week after appointment)
D: Percentage of patients up-to-date (UTD) for colorectal cancer (CRC) screening (18 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled Study of the JAK Inhibitor INCB018424 Tablets Administered Orally to Subjects With Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis or Post-Essential Thrombocythemia Myelofibrosis
Brief Summary: This was a randomized, double-blind study comparing the efficacy and safety of ruxolitinib (INCB018424) tablets to matching placebo tablets in patients diagnosed with Myelofibrosis (either Primary Myelofibrosis (PMF) or Post-Polycythemia Vera Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia Myelofibrosis (PET-MF).


Options:
A: Number of Participants Achieving ≥ 35% Reduction in Spleen Volume From Baseline to Week 24 (Baseline and Week 24)
B: Number of Patients With Objective Response (Complete and Partial Response + Hematological Improvement) (6 months)
C: Number of Participants With Adverse Events (AEs) (From Baseline to the interim clinical cut-off date (31 December 2009). The median time on study was 14.8 months, with a range of 26 days to 29.7 months. As of March 1, 2011 the total exposure to ruxolitinib was 269 patient-years.); Percentage of Participants With Clinical Improvement (CI) Over Time (Week 12, 24, 36, 48 and 60)
D: Number of Participants With Objective Response (Response assessed after each 3 cycles (cycle = 30 days))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Physiology Study Investigating the Effects of Supplementation and Depletion of Iron on Hypoxia-related Pulmonary Hypertension
Brief Summary: The study hypothesis is that body iron levels are important in determining the increase in lung blood pressure that occurs in response to low oxygen levels. The purpose of this study is to determine whether this is true at high altitude, where oxygen levels are low.


Options:
A: Change in Peak VO2 (mL/kg/min) from baseline to Week 24 (Week 24)
B: Self-reported patient global assessment (PGA) and NYHA functional status 24 weeks after initiation of therapy (24 weeks)
C: Iron bio-availability from oral iron supplementation (%) (up to 4 weeks); Serum hepcidin concentrations (1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 17, 19, 21, 23, 25 and 27 days)
D: Change in pulmonary artery systolic pressure (One week (SLR arm) and one month (CMS arm))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Multi-center, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial to Study the Safety, Tolerability and Efficacy of MK0869/Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated With High-Dose Cisplatin
Brief Summary: This study will demonstrate and confirm the efficacy and safety of MK0869 for the treatment of chemotherapy-induced nausea and vomiting in Chinese patients.


Options:
A: complete response (CR) (acute phase (within 24 hrs after onset of chemotherapy))
B: Patient vomiting
C: Complete response (CR: no emetic episodes and no rescue medication) rate in acute and delayed nausea and vomiting
D: Proportion of Participants With Complete Response 120 Hours Following Initiation of High-dose Cisplatin Chemotherapy in the Overall Phase of Cycle 1 (0 to 120 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity and Safety of Multiple Formulations of an A/H1N1 Pandemic Vaccine in Healthy Subjects Aged 6 Months to 9 Years
Brief Summary: The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine in toddlers and children.

Primary Objectives:

* To describe the immunogenicity of the candidate vaccines after each injection.
* To describe the safety of the candidate vaccines after each injection.


Options:
A: Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months (Pre-vaccination (Day 0) and 21 days post-vaccination); Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months (Pre-vaccination (Day 0) and Day 21 post-vaccination); Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months (Pre-vaccination (Day 0) and 21 days post-vaccination); Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years (Pre-vaccination (Day 0) and 21 days post-vaccination); Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years (Pre-vaccination (Day 0) and Day 21 post-vaccination); Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years (Pre-vaccination (Day 0) and Day 21 post-vaccination); Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months (Days 0 to 7 post-vaccination); Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months (Days 0 to 7 post-vaccination); Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years (Days 0 to 7 post vaccination)
B: The proportions of subjects and household contacts with serology-confirmed influenza infection during follow-up among the 2 intervention arms. (nine months)
C: laboratory-confirmed influenza infection (Dec to June each year for 3 years)
D: The primary endpoint for efficacy is the first episode in the first season in a study child of a culture-confirmed influenza illness, caused by community-acquired subtypes antigenically similar to those contained in the vaccine.

Answer: A