TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Early Palliative Care on Quality of Life of Patients With Advanced Cancer: a Randomised Controlled Trial.
Brief Summary: The World Health Organization (WHO) defines palliative care as an approach to improve the quality of life of patients and their families facing life-threatening illness, through prevention and relief of pain and of physical, psychosocial and spiritual problems. The WHO stresses that palliative care is applicable early in the course of the illness together with other therapies that are intended to cure or prolong life, such as chemotherapy or radiation therapy. For the benefit of the patient, palliative care is however often given (too) late in the course of the disease of incurably ill patients.

The aim of our study is to measure the effect of interventional palliative care on quality of life, mood and end-of-life care of patients with advanced cancer and their families. These patients have a limited life expectancy and a high symptom burden, this leads us to suggest that these patients may be benefited with palliative care soon after diagnosis of metastatic disease (interventional palliative care).

The research design of this study is a randomized controlled trial with, on the one hand, an intervention group in which patients and their families receive interventional palliative care in combination with standard cancer care and on the other hand a control group in which patients and their families receive only standard oncologic care. Participants in the intervention group will meet the palliative support team shortly after diagnosis. Afterwards, the palliative support will meet them at least once a month. This intervention focuses on topics such illness understanding, symptom management, decision making and coping with the disease. Participants in the control group will only meet with the palliative support team at the patient's own request or after referral by the oncologist or the nursing staff.


Options:
A: Quality of life of the patient and his family caregiver at baseline. (at baseline); Quality of life of the patient and his family caregiver at 12 weeks. (at 12 weeks); Quality of life of the patient and his family caregiver, 6-weekly after 12 weeks. (6-weekly after 12 weeks)
B: Reduction in the EORTC QLQ-C30 scale that constitutes the patient's primary need (Baseline, 3 weeks and 8 weeks)
C: Change in patient's quality of living over time (baseline, 6,12,18,24,36 and every 12 weeks until death or end of study); Quality of end of life care (chart review at time of death and caregiver proxy interview 2-3 months after patient death); Estimate and compare the hazard ratios and median survival before and after 1 year from enrollment (From enrollment until patient death or end of study); Change in caregiver quality of life, burden and grief over time (baseline, 6,12,18,24,36, and every 12 weeks until patient death or end of study)
D: length of stay hospital, intensive care unit and emergency admissions (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase I/II Study of Immunotherapy for Advanced CD19+ Chronic Lymphocytic Leukemia, Acute Lymphoblastic Leukemia/Lymphoma and Non-Hodgkin Lymphoma With Defined Subsets of Autologous T Cells Engineered to Express a CD19-Specific Chimeric Antigen Receptor
Brief Summary: This phase I/II trial studies the side effects and best dose of laboratory treated T cells to see how well they work in treating patients with chronic lymphocytic leukemia, non-Hodgkin lymphoma, or acute lymphoblastic leukemia that have come back or have not responded to treatment. T cells that are treated in the laboratory before being given back to the patient may make the body build an immune response to kill cancer cells.


Options:
A: Treatment-related adverse events (AEs) as assessed by CTCAE v4.03 (Up to 730 days after the final JCAR017 infusion); Dose-limiting toxicities of JCAR017 (28 days after first (single-dose schedule) or second (2-dose schedule) JCAR017 infusion); Objective response rate (ORR) (24 months)
B: Response rate and toxicity (6 months)
C: Death Within 8 Weeks of the Study Cell Infusion Thought to be Definitely or Probably Related to Chimeric Antigen Receptor (CAR) T Cell Therapy (Within 8 weeks of the study cell infusion); Dose Limiting Toxicities (30 days); Objective Response Rate of Complete Response and Partial Response (Up to 1 year); Overall Survival (Up to 1 year); Progression Free Survival (Up to 1 year)
D: Safety as assessed by dose limiting toxicities (DLTs) (28 days); Safety as assessed by determination of the maximum tolerated dose (MTD) (24 months); Safety as assessed by determination of the recommended phase 2 dose (RP2D) (24 months); Safety as assessed by and adverse events, laboratory assessments and physical examinations (24 months); Safety as assessed by mini-mental state examination (MMSE) (24 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Controlled Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma That Has Progressed After Prior VEGFR Tyrosine Kinase Inhibitor Therapy
Brief Summary: The purpose of this study is to evaluate the effect of Cabozantinib (XL184) compared with Everolimus (Afinitor) on progression-free survival (PFS) and overall survival (OS) in subjects with advanced renal cell cancer that has progressed after prior VEGFR tyrosine kinase inhibitor therapy.


Options:
A: Progression free survival (Randomization until earliest date of disease progression (according RECIST 1.1 criteria) or death, an expected average of one year)
B: 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.)
C: 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.)
D: Percentage of Participants With Disease Progression Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Via Independent Review Committee (IRC) Assessment or Death in Intent-to-Treat (ITT) Population (From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)); Progression-Free Survival (PFS) Per RECIST v1.1 Via IRC Assessment in ITT Population (From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)); Percentage of Participants With Disease Progression Per RECIST v1.1 Via IRC Assessment or Death in Immune Cell 1/2/3 (IC1/2/3) Population (From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)); PFS Per RECIST v1.1 Via IRC Assessment in IC1/2/3 Population (From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Naltrexone for Antipsychotic-Induced Weight Gain
Brief Summary: This study is designed to look at the effects of naltrexone on weight loss in individuals treated with antipsychotic medications. Naltrexone is an FDA approved medication for the management of alcohol dependence and drug dependence, but has not been fully evaluated for its effect on weight loss in individuals with severe mental illness (i.e. schizophrenia, schizoaffective disorder, bipolar disorder etc.) The purpose of this study is to find out how effective two different doses of oral naltrexone is on reducing body weight when compared to placebo (an inactive substance or "sugar pill").


Options:
A: Change in Weight From Baseline (Baseline and 52 weeks); Percent of Subjects Who Lost More Than 5% of Body Weight From Baseline (52 weeks)
B: Time from randomization to recurrence of a mood event
C: Evaluate the main and interactional effects of risperidone and olanzapine on body mass index (BMI), other measures of obesity, and other health-related factors, including total cholesterol, lipid panels, blood glucose, glycohemoglobin, and prolactin (twelve months)
D: Mean Change From Baseline to 52 Weeks in Body Mass Index (BMI) for All Participants (Baseline, 52 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: MAM'Out Project - Evaluation of Multiannual and Seasonal Cash Transfers to Prevent Acute Malnutrition
Brief Summary: The MAM'Out research project aims at evaluating a seasonal and multi-annual cash transfer program in the framework of a safety net to prevent acute malnutrition by children under 24 months, in terms of effectiveness and cost-effectiveness in the Tapoa province (East region of Burkina Faso, Africa). The program will be targeted to economically vulnerable households with children less than 1 year old at the time of inclusion and the cash distributed to mothers. The transfers will be assimilated to unconditional ones, leading to beneficiaries' self-determination on the use that will be made of cash. This study will be designed as a two-arm cluster randomized intervention trial, based on randomization of rural villages of the Tapoa province. One arm will receive the intervention and one will be a control arm. The main outcomes will be the cumulative incidence of acute malnutrition (or wasting) and the cost-effectiveness. Anthropometric measures (height, weight and MUAC) will be measured, as well as indicators of dietary diversity, food security, health center frequentation, families' expenses and morbidities. Questionnaires and 24-hour food recalls will also be analyzed. Finally, based on a model theory framework built a priori, the pathways used by the cash to have an effect on the prevention of under-nutrition will be assessed.


Options:
A: Growth (Measurements will be made for children between the ages of 3 and 12 months of age at baseline and then 2 years later, at endline, when the children are between the ages of 23 and 40 months); Hemoglobin (Measurements will be made for children between the ages of 3 and 12 months of age at baseline and then 2 years later, at endline, when the children are between the ages of 23 and 40 months)
B: Change from Baseline in nutritionally related biochemical measures at 22 months (At baseline and 22 months)
C: Child nutritional status
D: Cumulative incidence of child wasting (3-monthly until 24 months after inclusion); Incremental cost-effectiveness ratio (24 months after inclusion)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: MAM'Out Project - Evaluation of Multiannual and Seasonal Cash Transfers to Prevent Acute Malnutrition
Brief Summary: The MAM'Out research project aims at evaluating a seasonal and multi-annual cash transfer program in the framework of a safety net to prevent acute malnutrition by children under 24 months, in terms of effectiveness and cost-effectiveness in the Tapoa province (East region of Burkina Faso, Africa). The program will be targeted to economically vulnerable households with children less than 1 year old at the time of inclusion and the cash distributed to mothers. The transfers will be assimilated to unconditional ones, leading to beneficiaries' self-determination on the use that will be made of cash. This study will be designed as a two-arm cluster randomized intervention trial, based on randomization of rural villages of the Tapoa province. One arm will receive the intervention and one will be a control arm. The main outcomes will be the cumulative incidence of acute malnutrition (or wasting) and the cost-effectiveness. Anthropometric measures (height, weight and MUAC) will be measured, as well as indicators of dietary diversity, food security, health center frequentation, families' expenses and morbidities. Questionnaires and 24-hour food recalls will also be analyzed. Finally, based on a model theory framework built a priori, the pathways used by the cash to have an effect on the prevention of under-nutrition will be assessed.


Options:
A: Number of Participants With HIV Viral Load < 40 Copies/ML at 1 Year (1 year); Change From Baseline in CD4 Count at 1 Year (1 year)
B: Cumulative incidence of child wasting (3-monthly until 24 months after inclusion); Incremental cost-effectiveness ratio (24 months after inclusion)
C: Growth (Measurements will be made for children between the ages of 3 and 12 months of age at baseline and then 2 years later, at endline, when the children are between the ages of 23 and 40 months); Hemoglobin (Measurements will be made for children between the ages of 3 and 12 months of age at baseline and then 2 years later, at endline, when the children are between the ages of 23 and 40 months)
D: Child nutritional status

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: MAM'Out Project - Evaluation of Multiannual and Seasonal Cash Transfers to Prevent Acute Malnutrition
Brief Summary: The MAM'Out research project aims at evaluating a seasonal and multi-annual cash transfer program in the framework of a safety net to prevent acute malnutrition by children under 24 months, in terms of effectiveness and cost-effectiveness in the Tapoa province (East region of Burkina Faso, Africa). The program will be targeted to economically vulnerable households with children less than 1 year old at the time of inclusion and the cash distributed to mothers. The transfers will be assimilated to unconditional ones, leading to beneficiaries' self-determination on the use that will be made of cash. This study will be designed as a two-arm cluster randomized intervention trial, based on randomization of rural villages of the Tapoa province. One arm will receive the intervention and one will be a control arm. The main outcomes will be the cumulative incidence of acute malnutrition (or wasting) and the cost-effectiveness. Anthropometric measures (height, weight and MUAC) will be measured, as well as indicators of dietary diversity, food security, health center frequentation, families' expenses and morbidities. Questionnaires and 24-hour food recalls will also be analyzed. Finally, based on a model theory framework built a priori, the pathways used by the cash to have an effect on the prevention of under-nutrition will be assessed.


Options:
A: Cumulative incidence of child wasting (3-monthly until 24 months after inclusion); Incremental cost-effectiveness ratio (24 months after inclusion)
B: Proportion of Children Under 5 Years in Vulnerable Households That Have a Birth Certificate (1 year); Proportion of Children Under 5 Years in Vulnerable Households That Have Up-to-date Vaccinations (1 year); Proportion of Children Aged 6-12 Years That Attended Primary School 80% of Days in the Last Month (1 year)
C: Recovery rate in the outpatient therapeutic program (At 6 week)
D: Food security as measured by the value of food consumption through a household questionnaire (6 months); Dietary diversity as measured by dietary diversity index and food consumption score through a household questionnaire (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: MAM'Out Project - Evaluation of Multiannual and Seasonal Cash Transfers to Prevent Acute Malnutrition
Brief Summary: The MAM'Out research project aims at evaluating a seasonal and multi-annual cash transfer program in the framework of a safety net to prevent acute malnutrition by children under 24 months, in terms of effectiveness and cost-effectiveness in the Tapoa province (East region of Burkina Faso, Africa). The program will be targeted to economically vulnerable households with children less than 1 year old at the time of inclusion and the cash distributed to mothers. The transfers will be assimilated to unconditional ones, leading to beneficiaries' self-determination on the use that will be made of cash. This study will be designed as a two-arm cluster randomized intervention trial, based on randomization of rural villages of the Tapoa province. One arm will receive the intervention and one will be a control arm. The main outcomes will be the cumulative incidence of acute malnutrition (or wasting) and the cost-effectiveness. Anthropometric measures (height, weight and MUAC) will be measured, as well as indicators of dietary diversity, food security, health center frequentation, families' expenses and morbidities. Questionnaires and 24-hour food recalls will also be analyzed. Finally, based on a model theory framework built a priori, the pathways used by the cash to have an effect on the prevention of under-nutrition will be assessed.


Options:
A: Proportion of Children Under 5 Years in Vulnerable Households That Have a Birth Certificate (1 year); Proportion of Children Under 5 Years in Vulnerable Households That Have Up-to-date Vaccinations (1 year); Proportion of Children Aged 6-12 Years That Attended Primary School 80% of Days in the Last Month (1 year)
B: Food security as measured by the value of food consumption through a household questionnaire (6 months); Dietary diversity as measured by dietary diversity index and food consumption score through a household questionnaire (6 months)
C: Sexually Transmitted Infections (18 months); Schooling (12 months/24 months)
D: Cumulative incidence of child wasting (3-monthly until 24 months after inclusion); Incremental cost-effectiveness ratio (24 months after inclusion)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: MAM'Out Project - Evaluation of Multiannual and Seasonal Cash Transfers to Prevent Acute Malnutrition
Brief Summary: The MAM'Out research project aims at evaluating a seasonal and multi-annual cash transfer program in the framework of a safety net to prevent acute malnutrition by children under 24 months, in terms of effectiveness and cost-effectiveness in the Tapoa province (East region of Burkina Faso, Africa). The program will be targeted to economically vulnerable households with children less than 1 year old at the time of inclusion and the cash distributed to mothers. The transfers will be assimilated to unconditional ones, leading to beneficiaries' self-determination on the use that will be made of cash. This study will be designed as a two-arm cluster randomized intervention trial, based on randomization of rural villages of the Tapoa province. One arm will receive the intervention and one will be a control arm. The main outcomes will be the cumulative incidence of acute malnutrition (or wasting) and the cost-effectiveness. Anthropometric measures (height, weight and MUAC) will be measured, as well as indicators of dietary diversity, food security, health center frequentation, families' expenses and morbidities. Questionnaires and 24-hour food recalls will also be analyzed. Finally, based on a model theory framework built a priori, the pathways used by the cash to have an effect on the prevention of under-nutrition will be assessed.


Options:
A: HIV Viral Suppression (12 months)
B: Cumulative incidence of child wasting (3-monthly until 24 months after inclusion); Incremental cost-effectiveness ratio (24 months after inclusion)
C: Percent of Patients Taking Thiazide Diuretics and at BP Goal at Index Visit and 6 Months (index visit and 6 months)
D: Number of Participants Who Present Children for HIV Testing (2 months); Number of Days Participants Take to Bring Children for HIV Testing (2 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Combating Maternal Mortality in Uganda: An Assessment of the Role of Misoprostol in Prevention of Post-Partum Hemorrhage
Brief Summary: Null hypothesis: 10 IU Oxytocin is better than sublingual misoprostol 600µg in management of third stage of labor Alternative hypothesis: Sublingual misoprostol 600µg is non- inferior to 10 IU oxytocin and will not be more than 6% worse \[than 10 IU oxytocin\] in management of third stage of labor


Options:
A: Occurrence of post partum hemorrhage > 500mL in 1 hour (1 HOUR)
B: To evaluate the efficacy of buccal misoprostol in the prevention of uterine atony and postpartum hemorrhage (PPH) after caesarean section (an expected average 1 week)
C: Estimated Blood loss (24 hours)
D: Incidence of PPH (24 hours after birth)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Combating Maternal Mortality in Uganda: An Assessment of the Role of Misoprostol in Prevention of Post-Partum Hemorrhage
Brief Summary: Null hypothesis: 10 IU Oxytocin is better than sublingual misoprostol 600µg in management of third stage of labor Alternative hypothesis: Sublingual misoprostol 600µg is non- inferior to 10 IU oxytocin and will not be more than 6% worse \[than 10 IU oxytocin\] in management of third stage of labor


Options:
A: screening of Cessation of bleeding (screening until 24 hours after placenta disconnection); time duration to stop bleeding in the case of post-cesarean section (24 hours)
B: To evaluate the efficacy of buccal misoprostol in the prevention of uterine atony and postpartum hemorrhage (PPH) after caesarean section (an expected average 1 week)
C: Estimated Blood loss (24 hours)
D: Uterine tone. (2 minutes)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Controlled, Three-Arm, Phase III Study to Evaluate the Safety and Efficacy of Two Dosing Schedules of Pembrolizumab (MK-3475) Compared to Ipilimumab in Patients With Advanced Melanoma
Brief Summary: This study will evaluate the safety and efficacy of 2 different dosing schedules of pembrolizumab (MK-3475), every 2 weeks (Q2W) and every 3 weeks (Q3W), and compare the 2 schedules to treatment with ipilimumab in ipilimumab-naïve participants with unresectable or metastatic melanoma. The primary hypotheses are that pembrolizumab is superior to ipilimumab with respect to progression-free survival (PFS) and overall survival (OS).


Options:
A: Objective Response Rate (ORR) - BRAF Wild-type (WT) Participants (From 12 weeks after Randomization, assessed every 6 weeks up to Week 49 of study treatment and then every 12 weeks until disease progression (up to approximately 76 months))
B: Overall Response Rate (ORR) (Up to 36 months); Response to Treatment (Up to 36 months)
C: Progression-free Survival (PFS) According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Independent Radiology Plus Oncology Review (IRO) (Up to approximately 12 months (through first pre-specified statistical analysis cut-off date of 03-Sep-2014)); Percentage of Participants With Overall Survival (OS) at 12 Months (Month 12)
D: Disease free survival (3 years)

Answer: C