TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Fondaparinux Compared With Heparin to Prevent Thrombotic Complications and Graft Failure in Patients Undergoing Coronary Artery Bypass Graft Surgery
Brief Summary: (i) Main Research Question(s): What is the effect of fondaparinux on coronary graft patency, heart attack, stroke, and death in patients who have undergone coronary artery bypass grafting (CABG)? To reliably answer this question requires a large randomised trial. We propose a pilot study to demonstrate the feasibility of recruiting patients into this study and of performing CT angiograms to measure graft patency at 30 days.

(ii) Why is this research important? Coronary artery bypass surgery has made a very important contribution to improving the health and survival of patients with advanced coronary artery disease but still has many problems. One in 10 patients experiences a heart attack at the time of surgery, 1 in 20 experiences a heart attack, stroke, or death during hospitalization, and 1 in 4 patients has at least 1 blocked graft within 1 year of surgery. Fondaparinux, a relatively new anticoagulant drug, has been shown to significantly reduce cardiovascular events and death in patients who have suffered a recent heart attack. Compared to established anticoagulant therapies for acute myocardial infarction, fondaparinux has been shown to be more effective with similar or lower risks of bleeding.

Fondaparinux, unlike the most commonly used anticoagulants, does not cause Heparin Induced Thrombocytopenia (HIT), a rare condition with extremely high morbidity and mortality.

This drug has never been studied in CABG patients. Our pilot study will provide key information about feasibility that will help us to design and perform a large definitive study in the future.

(iii) What is being studied? We will be looking at blood flow in bypass grafts, heart attack, stroke, venous thromboembolism and death. For safety we will be looking at bleeding, transfusion, and need for further surgery because of bleeding. We will also perform laboratory tests for HIT antibodies as their levels are prognostic for the development of HIT and are also related to morbidity and mortality. The incidence of actual HIT cases will also be recorded.


Options:
A: Efficacy: Percent Change From Baseline in Anti-fXa Activity at the Nadir (Parts I and II) (Baseline to +2 minutes or +5 minutes following the end of andexanet/placebo bolus (Part I), or 10 minutes prior to end of andexanet/placebo continuous infusion or 5 minutes after the end of andexanet/placebo continuous infusion (Part II))
B: The Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE) (From Day 1 to Day 90 (±7 days))
C: Graft patency (28 days)
D: Symptomatic recurrent PE/DVT during the 6-month study treatment period.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Oscillation for ARDS Treated Early (OSCILLATE) Trial Pilot Study
Brief Summary: Acute respiratory distress syndrome (ARDS) is a common and catastrophic complication of critical illness related to burns, motor vehicle accidents, or overwhelming infection. ARDS kills 40-70% of affected patients. Patients with ARDS require life support in the form of a ventilator to breathe for them while their lungs heal. Ironically, ventilators can cause further damage to the lungs. We are conducting a study comparing 2 methods to protect the lungs from further damage. One method uses standard mechanical ventilators and the other uses a new type of ventilator, called a high frequency oscillator. We propose to test whether this high frequency oscillation will reduce the relative risk of dying from ARDS. 72 patients from 12 intensive care units in Canada and Saudi Arabia will participate in this preliminary study to test the feasibility of our study methods. If feasible, we plan to move on and conduct a large multinational study to definitively answer this question.


Options:
A: Survival to days 28 and 60 post-randomization, and to Hospital Discharge (28 days to more than 60 days post-randomization)
B: adherence to our explicit mechanical ventilation protocols; (duration of mechanical ventilation); to measure and understand the reasons for crossovers between groups (duration of mechanical ventilation); to estimate the rate of patient recruitment, and understand barriers to recruitment; to document our ability to achieve close to complete follow-up for mortality and quality of life in the 6 months following enrolment
C: Mortality (at 28 days)
D: Physiological variables (i.e. ventilation pressures and oxygenation) during the first 7-10 days following randomization (8-10 days post-randomization); Survival to days 28 and 60 post-randomization and to Hospital Discharge (28 days to more than 60 days post-randomization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Oscillation for ARDS Treated Early (OSCILLATE) Trial Pilot Study
Brief Summary: Acute respiratory distress syndrome (ARDS) is a common and catastrophic complication of critical illness related to burns, motor vehicle accidents, or overwhelming infection. ARDS kills 40-70% of affected patients. Patients with ARDS require life support in the form of a ventilator to breathe for them while their lungs heal. Ironically, ventilators can cause further damage to the lungs. We are conducting a study comparing 2 methods to protect the lungs from further damage. One method uses standard mechanical ventilators and the other uses a new type of ventilator, called a high frequency oscillator. We propose to test whether this high frequency oscillation will reduce the relative risk of dying from ARDS. 72 patients from 12 intensive care units in Canada and Saudi Arabia will participate in this preliminary study to test the feasibility of our study methods. If feasible, we plan to move on and conduct a large multinational study to definitively answer this question.


Options:
A: Mortality (at 28 days)
B: Mortality (Measured at Months 3, 6, 12, 24, 36, 48 and 60)
C: adherence to our explicit mechanical ventilation protocols; (duration of mechanical ventilation); to measure and understand the reasons for crossovers between groups (duration of mechanical ventilation); to estimate the rate of patient recruitment, and understand barriers to recruitment; to document our ability to achieve close to complete follow-up for mortality and quality of life in the 6 months following enrolment
D: 28-day mortality from all causes (28 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial Of Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced Renal Cell Carcinoma Who Have Failed First-Line Sunitinib Therapy
Brief Summary: This is an international, randomized, open-label, outpatient, multicenter study. Subjects will be assigned in a 1:1 ratio to 1 of 2 treatment arms: temsirolimus 25 mg once weekly by intravenous (IV) infusion or sorafenib 400 mg by mouth (PO) twice daily (BID). These investigational drugs will be administered in 6-week cycles for the duration of the study, up to 24 months. Subjects will be stratified by nephrectomy status, duration of response to sunitinib therapy, Memorial Sloan Kettering Cancer Center (MSKCC) prognostic group, and RCC tumor histology.


Options:
A: Progression-free Survival (PFS) (PFS is measured from the date of randomization until the date of first documented disease progression or date of death from any cause as determined by the Independent Radiology Committee (IRC) per RECIST 1.1, assessed for up to 17 months.)
B: Progression Free Survival (PFS) (From randomization to disease progression or death (up to approximately 2 years))
C: Percentage of Participants With Disease Progression as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Death From Any Cause in Programmed Death-Ligand 1 (PD-L1)-Selected Population (Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)); Progression-Free Survival (PFS) as Determined by the Investigator According to RECIST v1.1 in PD-L1-Selected Population (Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)); Percentage of Participants Who Died of Any Cause in ITT Population (Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months)); Overall Survival (OS) in ITT Population (Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months))
D: Progression-Free Survival (PFS) (Baseline up to 24 Months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of the Integrated Management of Neonatal and Childhood Illness Strategy on Neonatal and Infant Mortality in Haryana, India
Brief Summary: This study is a cluster-randomized trial being conducted in the state of Haryana in North India. Eighteen geographical areas served by Primary Health Centres (PHCs) have been randomized to intervention or comparison areas. In the intervention areas, all physicians, health workers and ICDS workers are being trained in the IMNCI. Each of these clusters has an approximate population of 30,000.

The IMNCI intervention includes three main components:

1. improvement in the case management skills of health staff
2. improvement in the overall health system to support its performance, and
3. improvement in family and community health care practices which include:

   * prevention and management of hypothermia
   * early initiation of breastfeeding and exclusive breastfeeding
   * community-based care of low birth weight infants
   * improved care-seeking for neonatal infections

The primary outcome measures of the study are neonatal and infant mortality. The study will also collect information on cause-specific neonatal mortality, ascertained using a standardized previously validated verbal autopsy instrument administered by trained, skilled health workers. All the other outcomes (including initiation of breastfeeding within 1 hour of birth; Exclusive breastfeeding at 4 weeks of age; Proportion of neonates identified to be sick by caregivers who sought care) are secondary outcomes.

The effectiveness of this comprehensive intervention will be measured by comparing the primary and secondary outcome measures in the intervention and comparison clusters, controlling for any baseline differences such as the predefined outcomes and/or socioeconomic status and demography.

The project will serve as a guide to the Government of India of how to best implement the IMNCI strategy and measure its impact.


Options:
A: Post day 1 Neonatal mortality (birth to 28 days of age) in the communities receiving the intervention(cohort of infants born to women identified through pregnancy surveillance) (Over 30 Months); Neonatal mortality (from birth to 28 days of age) in the cohort identified through pregnancy surveillance (Over 30 Months); Post day 1 neonatal mortality (1 to 28 days of age) in the population of newborns who are more likely to have greater impact from the intervention i.e. those born at home and available in the study area within 7 days of birth (30 months); Neonatal mortality (from birth to 28 days of age) in the population more likely to benefit from the intervention (30 months); Infant mortality (birth to 365 days) in the communities receiving the intervention. (30 months)
B: Number of death in children aged 6 to 59 months (12 months)
C: All cause Neonatal Mortality (2 years)
D: mortality (day 28)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of the Integrated Management of Neonatal and Childhood Illness Strategy on Neonatal and Infant Mortality in Haryana, India
Brief Summary: This study is a cluster-randomized trial being conducted in the state of Haryana in North India. Eighteen geographical areas served by Primary Health Centres (PHCs) have been randomized to intervention or comparison areas. In the intervention areas, all physicians, health workers and ICDS workers are being trained in the IMNCI. Each of these clusters has an approximate population of 30,000.

The IMNCI intervention includes three main components:

1. improvement in the case management skills of health staff
2. improvement in the overall health system to support its performance, and
3. improvement in family and community health care practices which include:

   * prevention and management of hypothermia
   * early initiation of breastfeeding and exclusive breastfeeding
   * community-based care of low birth weight infants
   * improved care-seeking for neonatal infections

The primary outcome measures of the study are neonatal and infant mortality. The study will also collect information on cause-specific neonatal mortality, ascertained using a standardized previously validated verbal autopsy instrument administered by trained, skilled health workers. All the other outcomes (including initiation of breastfeeding within 1 hour of birth; Exclusive breastfeeding at 4 weeks of age; Proportion of neonates identified to be sick by caregivers who sought care) are secondary outcomes.

The effectiveness of this comprehensive intervention will be measured by comparing the primary and secondary outcome measures in the intervention and comparison clusters, controlling for any baseline differences such as the predefined outcomes and/or socioeconomic status and demography.

The project will serve as a guide to the Government of India of how to best implement the IMNCI strategy and measure its impact.


Options:
A: Placental malaria (After delivery)
B: Neonatal mortality rate (deaths within 28 days of birth)
C: Post day 1 Neonatal mortality (birth to 28 days of age) in the communities receiving the intervention(cohort of infants born to women identified through pregnancy surveillance) (Over 30 Months); Neonatal mortality (from birth to 28 days of age) in the cohort identified through pregnancy surveillance (Over 30 Months); Post day 1 neonatal mortality (1 to 28 days of age) in the population of newborns who are more likely to have greater impact from the intervention i.e. those born at home and available in the study area within 7 days of birth (30 months); Neonatal mortality (from birth to 28 days of age) in the population more likely to benefit from the intervention (30 months); Infant mortality (birth to 365 days) in the communities receiving the intervention. (30 months)
D: mortality (day 28)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of the Integrated Management of Neonatal and Childhood Illness Strategy on Neonatal and Infant Mortality in Haryana, India
Brief Summary: This study is a cluster-randomized trial being conducted in the state of Haryana in North India. Eighteen geographical areas served by Primary Health Centres (PHCs) have been randomized to intervention or comparison areas. In the intervention areas, all physicians, health workers and ICDS workers are being trained in the IMNCI. Each of these clusters has an approximate population of 30,000.

The IMNCI intervention includes three main components:

1. improvement in the case management skills of health staff
2. improvement in the overall health system to support its performance, and
3. improvement in family and community health care practices which include:

   * prevention and management of hypothermia
   * early initiation of breastfeeding and exclusive breastfeeding
   * community-based care of low birth weight infants
   * improved care-seeking for neonatal infections

The primary outcome measures of the study are neonatal and infant mortality. The study will also collect information on cause-specific neonatal mortality, ascertained using a standardized previously validated verbal autopsy instrument administered by trained, skilled health workers. All the other outcomes (including initiation of breastfeeding within 1 hour of birth; Exclusive breastfeeding at 4 weeks of age; Proportion of neonates identified to be sick by caregivers who sought care) are secondary outcomes.

The effectiveness of this comprehensive intervention will be measured by comparing the primary and secondary outcome measures in the intervention and comparison clusters, controlling for any baseline differences such as the predefined outcomes and/or socioeconomic status and demography.

The project will serve as a guide to the Government of India of how to best implement the IMNCI strategy and measure its impact.


Options:
A: Neonatal mortality rate
B: Post day 1 Neonatal mortality (birth to 28 days of age) in the communities receiving the intervention(cohort of infants born to women identified through pregnancy surveillance) (Over 30 Months); Neonatal mortality (from birth to 28 days of age) in the cohort identified through pregnancy surveillance (Over 30 Months); Post day 1 neonatal mortality (1 to 28 days of age) in the population of newborns who are more likely to have greater impact from the intervention i.e. those born at home and available in the study area within 7 days of birth (30 months); Neonatal mortality (from birth to 28 days of age) in the population more likely to benefit from the intervention (30 months); Infant mortality (birth to 365 days) in the communities receiving the intervention. (30 months)
C: Treatment failure (within 7 days of enrolment)
D: mortality (day 28)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Controlled Multicenter Clinical Trial to Evaluate the Safety and Effectiveness of the IBV® Valve System for the Treatment of Severe Emphysema
Brief Summary: This trial is for men and women between the ages of 40 and 74 who have a confirmed diagnosis of emphysema. The objective of the trial is to determine the safety and effectiveness of the IBV Valve at redirecting airflow from diseased portions of the lung to healthier areas to achieve improvement in disease-related health status.


Options:
A: Lung Volume Change (30 Days)
B: Occurence of adverse events (serious and non-serious) secondary to the BTVA treatment procedure from initiation of treatment through completion of the six-month follow-up period (6 months)
C: Difference between responder rates of the treatment & control groups, responders defined as subjects with clinically meaningful improvements in disease-related health status (SGRQ) & regional lung volume changes as measured by quantitative CT scan. (6 months)
D: Pulmonary function testing at various time points through one year; Exercise tolerance at various time points through one year; Major complications at various time points through one year

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Delayed Nausea A Phase III Double-Blind Placebo-Controlled Clinical Trial
Brief Summary: RATIONALE: Antiemetic drugs, such as granisetron, dexamethasone, prochlorperazine, aprepitant, and palonosetron, may help lessen or prevent nausea. It is not yet known which combination of antiemetic drugs is more effective in preventing nausea caused by chemotherapy.

PURPOSE: This randomized phase III trial is comparing different combinations of granisetron, dexamethasone, prochlorperazine, aprepitant, and palonosetron to see how well they work in preventing nausea in patients undergoing chemotherapy for breast cancer.


Options:
A: No Emetic Episodes and No Rescue Medication (>24 to 120 hours post chemotherapy)
B: Home Record: Severity of Delayed Nausea (average of day 1 afternoon, evening and night, and all of days 2 and 3)
C: Percentage of Participants Who Achieved a Complete Response in the Overall Phase (0-120 Hours) Following Initiation of the First Cycle of an Oxaliplatin Based Moderately Emetogenic Chemotherapy (MEC) Regimen (0 to 120 hours in the first cycle of chemotherapy)
D: Complete Protection from Vomiting (ie.Complete Response in Preventing Vomiting) (0-24h, 24-120h , 0-120h following chemotherapy)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Low Molecular Weight Heparin on Survival of Stage I,II or IIIA Non Small Cell Lung Cancer. A Multicenter, Open, Randomized Controlled Trial.
Brief Summary: Experiments suggest that low molecular weight heparin (LMWH) inhibits tumor growth and metastasis. Studies in humans suggest that LMWH is associated with a higher survival in patients with cancer related thrombosis. Two recent studies suggest that LMWH may increase the survival of patients with cancer who do not have an associated thrombosis. The purpose of the study is to assess the effect of LMWH on the overall survival of patients with localized non-small cell lung cancer after complete surgical resection.


Options:
A: Thromboembolic events (during study treatment)
B: Incidence of venous thromboembolism reduction
C: Overall 3-year mortality (overall 3-years)
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: Effect of Low Molecular Weight Heparin on Survival of Stage I,II or IIIA Non Small Cell Lung Cancer. A Multicenter, Open, Randomized Controlled Trial.
Brief Summary: Experiments suggest that low molecular weight heparin (LMWH) inhibits tumor growth and metastasis. Studies in humans suggest that LMWH is associated with a higher survival in patients with cancer related thrombosis. Two recent studies suggest that LMWH may increase the survival of patients with cancer who do not have an associated thrombosis. The purpose of the study is to assess the effect of LMWH on the overall survival of patients with localized non-small cell lung cancer after complete surgical resection.


Options:
A: Percent Change in D-dimer Value (Baseline, 56 Day)
B: Overall 3-year mortality (overall 3-years)
C: Recurrent (symptomatic) vein thromboembolism, including pulmonary embolism and deep vein thrombosis (one year)
D: Progression free survival (5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Low Molecular Weight Heparin on Survival of Stage I,II or IIIA Non Small Cell Lung Cancer. A Multicenter, Open, Randomized Controlled Trial.
Brief Summary: Experiments suggest that low molecular weight heparin (LMWH) inhibits tumor growth and metastasis. Studies in humans suggest that LMWH is associated with a higher survival in patients with cancer related thrombosis. Two recent studies suggest that LMWH may increase the survival of patients with cancer who do not have an associated thrombosis. The purpose of the study is to assess the effect of LMWH on the overall survival of patients with localized non-small cell lung cancer after complete surgical resection.


Options:
A: 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)
B: Overall 3-year mortality (overall 3-years)
C: Significant increase of overall survival (At follow up 1 year after treatment)
D: Progression Free Survival (during chemotherapy and follow-up)

Answer: B