TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Randomized Phase 3 Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Subjects With Chemotherapy-Naïve Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)
Brief Summary: The purpose of this study is to show that Nivolumab, or Nivolumab plus Ipilimumab, or Nivolumab plus Platinum-Doublet Chemotherapy improves progression free survival and/or overall survival compared with chemotherapy in patients with advanced lung cancer.


Options:
A: Overall survival (OS) (approximately 48 months); Progression-free Survival (PFS) as determined by blinded independent central review (BICR) (approximately 40 months)
B: Progression Free Survival (PFS), as Determined by the Investigator in Arm B Versus Arm C in the Teff-high WT Population and ITT-WT Population (Baseline until disease progression or death, whichever occurs first until data cut-off on 15 September 2017 (up to approximately 29 months)); Overall Survival (OS) in Arm B Versus Arm C in ITT-WT Population (Baseline until death until data cut-off on 22 January 2018 (up to approximately 34 months)); Overall Survival (OS) in Arm A Versus Arm C in ITT-WT Population (Baseline until death (up approximately 53 months))
C: Overall Survival (OS) in the TC3 or IC3-WT Populations (From randomization to death from any cause until data cut-off on 10 September 2018 (up to approximately 38 months)); Overall Survival (OS) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations (From randomization to death from any cause until data cut-off on 4 February 2020 (up to approximately 54.5 months))
D: Percentage of Participants Who Died: PP-ITT (Baseline until death due to any cause (up to approximately 2.25 years)); Percentage of Participants Who Died: Tumor Cells (TC)1/2/3 or Tumor-Infiltrating Immune Cells (IC)1/2/3 Subgroup of PP (Baseline until death due to any cause (up to approximately 2.25 years)); Overall Survival (OS): PP-ITT (Baseline until death due to any cause (up to approximately 2.25 years)); OS: TC1/2/3 or IC1/2/3 Subgroup of PP (Baseline until death due to any cause (up to approximately 2.25 years)); OS: SP-ITT (Baseline until death due to any cause (up to approximately 2.87 years)); OS: TC1/2/3 Or IC1/2/3 Subgroup of SP (Baseline until death from any cause (approximately 2.87 years)); OS: TC2/3 or IC2/3 Subgroup of SP (Baseline until death due to any cause (up to approximately 2.87 years)); OS: TC3 or IC3 Subgroup of SP (Baseline until death due to any cause (up to approximately 2.87 years))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Randomized Phase 3 Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Subjects With Chemotherapy-Naïve Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)
Brief Summary: The purpose of this study is to show that Nivolumab, or Nivolumab plus Ipilimumab, or Nivolumab plus Platinum-Doublet Chemotherapy improves progression free survival and/or overall survival compared with chemotherapy in patients with advanced lung cancer.


Options:
A: Toxicity Rate (Date of patient registration until 6 months after the administration of the last treatment (a maximum of 2 years treatment and 6 months followup after end of treatment)); Durable Clinical Benefit (≥18 weeks, up to maximum of 2 years)
B: Overall survival (OS) (approximately 48 months); Progression-free Survival (PFS) as determined by blinded independent central review (BICR) (approximately 40 months)
C: Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (Up to approximately 19 months); Overall Survival (OS) (Up to approximately 19 months)
D: Overall survival (From date of randomization until the date of date of death from any cause, whichever came first, assessed up to 3 years maximum)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Randomized Phase 3 Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Subjects With Chemotherapy-Naïve Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)
Brief Summary: The purpose of this study is to show that Nivolumab, or Nivolumab plus Ipilimumab, or Nivolumab plus Platinum-Doublet Chemotherapy improves progression free survival and/or overall survival compared with chemotherapy in patients with advanced lung cancer.


Options:
A: Investigator-assessed Objective Progression-free Survival (PFS) (Date of randomization to the date of measured PD or date of death from any cause (up to 19.3 months))
B: Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint (Randomization until 199 deaths, up to November 2014, approximately 25 months); Overall Survival (OS) Rate in All Randomized Participants (Randomization to 18 months post-randomization, up to June 2015); Number of Deaths From Any Cause in All Randomized Participants at Primary Endpoint (Randomization until 199 deaths, up to November 2014, approximately 25 months)
C: Overall survival (OS) (approximately 48 months); Progression-free Survival (PFS) as determined by blinded independent central review (BICR) (approximately 40 months)
D: Progression Free Survival (PFS) Rate at Month 6 (Month 6)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Randomized Phase 3 Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Subjects With Chemotherapy-Naïve Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)
Brief Summary: The purpose of this study is to show that Nivolumab, or Nivolumab plus Ipilimumab, or Nivolumab plus Platinum-Doublet Chemotherapy improves progression free survival and/or overall survival compared with chemotherapy in patients with advanced lung cancer.


Options:
A: Overall Survival (OS) (Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)); Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)); Percentage of Participants Experiencing Adverse Events (AEs) (Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)); Percentage of Participants Discontinuing Study Drug Due to AEs (Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months))
B: Overall survival (OS) (approximately 48 months); Progression-free Survival (PFS) as determined by blinded independent central review (BICR) (approximately 40 months)
C: Overall Survival (OS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab Monotherapy Vs SoC Chemotherapy and Durvalumab + Tremelimumab Vs SoC Chemotherapy (From baseline (Day 1, Week 0) until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years).); Progression-Free Survival (PFS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab + Tremelimumab Vs SoC Chemotherapy (Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).)
D: Investigator-assessed Objective Progression-free Survival (PFS) (Date of randomization to the date of measured PD or date of death from any cause (up to 19.3 months))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Randomized study to evaluate the efficacy and safety of nafamostat mesilate use during continuous renal replacement therapy in acute kidney injury patients at a high risk of bleeding.


Options:
A: 60-day All-cause Mortality (60 days)
B: Number of filters used per hour (24 months)
C: Survival at 2 weeks after RRT (2 weeks after RRT in follow-up)
D: bleeding complications (during administration of study anticoagulant); transfusion requirement (during administration of study anticoagulant); filter survival (during hemofiltration)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Randomized study to evaluate the efficacy and safety of nafamostat mesilate use during continuous renal replacement therapy in acute kidney injury patients at a high risk of bleeding.


Options:
A: 60-day All-cause Mortality (60 days)
B: Number of filters used per hour (24 months)
C: The incidence of premature interruptions of the dialysis procedure attributed to hemofilter clotting. (6 hours after starting dialysis)
D: Mortality (Day 28 after ICU admission)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Randomized study to evaluate the efficacy and safety of nafamostat mesilate use during continuous renal replacement therapy in acute kidney injury patients at a high risk of bleeding.


Options:
A: Number of filters used per hour (24 months)
B: bleeding complications (during administration of study anticoagulant); transfusion requirement (during administration of study anticoagulant); filter survival (during hemofiltration)
C: Accumulation of anti-Xa activity in plasma and removal of anti-Xa activity by filtration. (24 hours)
D: Mean running time of a maximum of two consecutive haemodialysis circuits (seven days starting at time of HIT suspicion)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of MK-3641, a Ragweed (Ambrosia Artemisiifolia) Sublingual Immunotherapy Tablet, in Children With a History of Ragweed-Induced Rhinoconjunctivitis With or Without Asthma
Brief Summary: The purpose of this study is to assess the efficacy and safety of short ragweed pollen allergen extract (MK-3641, SCH 039641, RAGWITEK™) sublingual immunotherapy tablets in children aged 5 to 17 years with ragweed-induced allergic rhinitis/rhinoconjunctivitis with or without asthma. The primary hypothesis of this study is that administration of short ragweed pollen allergen extract sublingual immunotherapy tablets to children 5 to 17 years of age, compared with placebo, will result in a significant reduction in the combination of rhinoconjunctivitis symptoms and medication use over the peak ragweed season (RS).


Options:
A: Total Combined Score (TCS) During the Peak Ragweed Season (RS) (The 15-day period during the ragweed season with the highest moving pollen average)
B: Changes of Symptom-Medication-Score (After 1 year of treatment)
C: Recording of allergy symptoms (Grass pollen season 2007)
D: Average Total Combined Rhinitis Score (TCRS) During Last 8 Weeks of Treatment (Last 8 weeks of treatment (Weeks 44 to 52)); Number of Participants Who Experience At Least One Adverse Event (AE) (Up to 54 weeks); Number of Participants Who Discontinue Study Drug Due to an AE (Up to 52 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Cluster Randomised Trial on the Impact of Integrating Early Infant HIV Diagnosis With the Expanded Programme on Immunization on Immunization and HIV Testing Rates in Rural Zambian Health Facilities
Brief Summary: This randomized evaluation measured the impact of two levels of support for the integration of infant and postpartum maternal HIV testing with routine immunization services in Southern Zambia on the number of postpartum maternal HIV tests, infant HIV tests, and 1st dose diphtheria, pertussis, and tetanus (DPT1) vaccines.


Options:
A: Immunization coverage (12 months); Timeliness of receipt of scheduled immunization (12 months)
B: Change in average monthly number of infant DBS HIV tests (Baseline and 6 mos (endline)); Change in average monthly number of maternal postpartum HIV tests (Baseline and 6 mos (endline)); Change in average monthly number of DPT1 doses administered (Baseline and 6 mos (endline))
C: 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)
D: Self-reported adherence on antiretroviral therapy (12 months post-partum); Adherence on antiretroviral therapy (12 months post-partum); Adherence on antiretroviral therapy (infant) (12 months post-partum); Retention in care (12 months post-partum); Adherence on antiretroviral therapy (dried blood spots) (12 months post-partum)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomized Trial on Laparoscopic Subtotal Hysterectomy During Sacral Colpopexy for the Treatment of Severe Pelvic Organ Prolapse (POP) With Bipolar Laparoscopic Loop/Bipolar Morcellator vs Conventional Monopolar Hook/Conventional Morcellator
Brief Summary: This prospective randomized pilot study is aimed to verify if the operative time of a standard laparoscopic sacral colpopexy associated to subtotal hysterectomy for the treatment of POP could be further reduced using PKS BILL: bipolar laparoscopic loop (a laparoscopic loop using advanced bipolar energy) (Olympus Medical Systems Corp, Tokyo) and PKS PlasmaSORD (Solid Organ Removal Device) vs. conventional monopolar hook and conventional mechanic morcellator.


Options:
A: Operative time for LPS subtotal hysterectomy and sacral colpopexy (participants will be followed for the duration of hospital stay, , an expected average of 5 weeks)
B: Comparison of surgical time (Up to four months (2 weeks before surgery until 3 months post-surgery).)
C: Cumulative Failure (6 Months through 36 Months)
D: Surgical Failure (6 months and 1, 2, 3, 4, and 5 years); Recruitment Into E-OPTIMAL (At 24 Months post OPTIMAL Treatment); Retention in E-OPTIMAL (3, 4, and 5 Years Post OPTIMAL Treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: mWELLCARE:An Integrated mHealth System for the Prevention and Care of Chronic Disease
Brief Summary: Major barriers to controlling cardiovascular diseases (CVDs) in India and elsewhere are: low detection rates, inadequate use of evidence based interventions and low adherence with these interventions. Primary health care is the appropriate setting for improving the prevention and management of these chronic conditions. The investigators will develop and evaluate an innovative mobile health (mHealth) software application -'m-WELLCARE'- which provides a patient health profile, decision support for clinical care, monitoring and feedback for use in Indian Community Health Centers (CHCs). The investigators will conduct this research following the steps proposed by the medical research council (MRC) for evaluation of complex interventions. Technical development of m-WELLCARE will be conducted, user acceptability appraised and potential barriers overcome. m-WELLCARE will be evaluated in CHCs of two states, Haryana and Karnataka. The use made of m-WELLCARE, its impact on patterns of health care received and changes in risk factors achieved will be evaluated.


Options:
A: Multiple CVD risk factor control targets (42 months after randomization)
B: Change in Glycated Hemoglobin (Baseline and 3 months)
C: Systolic blood Pressure (Baseline and 12 months); Glycated haemoglobin (HbA1c) (Baseline and 12 months)
D: Change in HbA1c (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: mWELLCARE:An Integrated mHealth System for the Prevention and Care of Chronic Disease
Brief Summary: Major barriers to controlling cardiovascular diseases (CVDs) in India and elsewhere are: low detection rates, inadequate use of evidence based interventions and low adherence with these interventions. Primary health care is the appropriate setting for improving the prevention and management of these chronic conditions. The investigators will develop and evaluate an innovative mobile health (mHealth) software application -'m-WELLCARE'- which provides a patient health profile, decision support for clinical care, monitoring and feedback for use in Indian Community Health Centers (CHCs). The investigators will conduct this research following the steps proposed by the medical research council (MRC) for evaluation of complex interventions. Technical development of m-WELLCARE will be conducted, user acceptability appraised and potential barriers overcome. m-WELLCARE will be evaluated in CHCs of two states, Haryana and Karnataka. The use made of m-WELLCARE, its impact on patterns of health care received and changes in risk factors achieved will be evaluated.


Options:
A: Psychosocial Stress: Insecurity (Regional Measure) (11 weeks); Psychosocial stress: Distress (Regional Measure) (11 weeks); Psychosocial Stress (International Measure) (11 weeks)
B: Child development composite score (Change children's cognition, language and motor as composite score after one year intervention); Children's behavior and composite score (Change children's behaviour after one year intervention)
C: The primary outcome is the number of outcomes out of 15 outcomes significantly favoring the intervention over the control (Harwood, Weiss & Comulada, 2017) (Baseline to 18 months)
D: Systolic blood Pressure (Baseline and 12 months); Glycated haemoglobin (HbA1c) (Baseline and 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: mWELLCARE:An Integrated mHealth System for the Prevention and Care of Chronic Disease
Brief Summary: Major barriers to controlling cardiovascular diseases (CVDs) in India and elsewhere are: low detection rates, inadequate use of evidence based interventions and low adherence with these interventions. Primary health care is the appropriate setting for improving the prevention and management of these chronic conditions. The investigators will develop and evaluate an innovative mobile health (mHealth) software application -'m-WELLCARE'- which provides a patient health profile, decision support for clinical care, monitoring and feedback for use in Indian Community Health Centers (CHCs). The investigators will conduct this research following the steps proposed by the medical research council (MRC) for evaluation of complex interventions. Technical development of m-WELLCARE will be conducted, user acceptability appraised and potential barriers overcome. m-WELLCARE will be evaluated in CHCs of two states, Haryana and Karnataka. The use made of m-WELLCARE, its impact on patterns of health care received and changes in risk factors achieved will be evaluated.


Options:
A: extent to which a computer-based clinical decision-support system (accompanying computerized provider order-entry) can improve the quality of medication ordering and monitoring (two years)
B: Degree of evidence-based guideline-concordant care for CKD (up to 3 years)
C: The primary outcome of this study will be focused on changes in doctor behavior and the comparison of the number of diagnostic tests ordered (chest x-rays) and antibiotics prescribed per patient encountered per diagnosis. (Comparisons between case and control ordering will be measured after a year of using the EMR tool)
D: Systolic blood Pressure (Baseline and 12 months); Glycated haemoglobin (HbA1c) (Baseline and 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: mWELLCARE:An Integrated mHealth System for the Prevention and Care of Chronic Disease
Brief Summary: Major barriers to controlling cardiovascular diseases (CVDs) in India and elsewhere are: low detection rates, inadequate use of evidence based interventions and low adherence with these interventions. Primary health care is the appropriate setting for improving the prevention and management of these chronic conditions. The investigators will develop and evaluate an innovative mobile health (mHealth) software application -'m-WELLCARE'- which provides a patient health profile, decision support for clinical care, monitoring and feedback for use in Indian Community Health Centers (CHCs). The investigators will conduct this research following the steps proposed by the medical research council (MRC) for evaluation of complex interventions. Technical development of m-WELLCARE will be conducted, user acceptability appraised and potential barriers overcome. m-WELLCARE will be evaluated in CHCs of two states, Haryana and Karnataka. The use made of m-WELLCARE, its impact on patterns of health care received and changes in risk factors achieved will be evaluated.


Options:
A: Primary composite outcome (4 years)
B: Systolic blood Pressure (Baseline and 12 months); Glycated haemoglobin (HbA1c) (Baseline and 12 months)
C: Medication Adherence (12 months after intervention); Mean Proportion of Days Covered Relative to Usual Care (12 months)
D: Combined adherence endpoint (at Visit 2 (follow-up visit after 3 months of intervention period))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: mWELLCARE:An Integrated mHealth System for the Prevention and Care of Chronic Disease
Brief Summary: Major barriers to controlling cardiovascular diseases (CVDs) in India and elsewhere are: low detection rates, inadequate use of evidence based interventions and low adherence with these interventions. Primary health care is the appropriate setting for improving the prevention and management of these chronic conditions. The investigators will develop and evaluate an innovative mobile health (mHealth) software application -'m-WELLCARE'- which provides a patient health profile, decision support for clinical care, monitoring and feedback for use in Indian Community Health Centers (CHCs). The investigators will conduct this research following the steps proposed by the medical research council (MRC) for evaluation of complex interventions. Technical development of m-WELLCARE will be conducted, user acceptability appraised and potential barriers overcome. m-WELLCARE will be evaluated in CHCs of two states, Haryana and Karnataka. The use made of m-WELLCARE, its impact on patterns of health care received and changes in risk factors achieved will be evaluated.


Options:
A: Target goal of HbA1c (< 7.0%) without hypoglycemia (24 weeks)
B: Systolic blood Pressure (Baseline and 12 months); Glycated haemoglobin (HbA1c) (Baseline and 12 months)
C: Estimated Percentage of Participants in Blood Pressure Control at Baseline (Baseline); Estimated Percentage of Participants in Blood Pressure Control at 6 Months (6month); Estimated Percentage of Participants in Blood Pressure Control at 12 Months (12 month); Estimated Percentage of Participants in Blood Pressure Control at 18 Months (18 month); Blood Pressure Averages Systolic & Diastolic (Baseline); Blood Pressure Averages Systolic & Diastolic (12-month)
D: Percentage of subjects with average day-time ambulatory blood pressure <135/85 mmHg (6 months); Percentage of subjects with average day-time ambulatory blood pressure <135/85 mmHg (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of a 5:2 Diet on Weight Loss and Cardiovascular Risk Factors in Obesity
Brief Summary: A randomized clinical trial comparing the effect on weight reduction and cardiometabolic risk factors of intermittent energy restriction and a isocaloric continuous energy restriction in obese subjects.


Options:
A: Fat mass (8 weeks); Fat-free mass (8 weeks); Body fat percentage (8 weeks); Upper body muscle hypertrophy (8 weeks); Lower body muscle hypertrophy (8 weeks)
B: Change in body weight (baseline, 8 weeks)
C: weight reduction (1 year)
D: Body weight (Change from baseline to week 24)

Answer: C