TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Care Management on Diabetes Outcomes
Brief Summary: The purpose of the study is to determine if a nurse managed, protocol driven, disease management process for diabetes results in improved attainment of therapeutic goals for diabetes compared to usual care. It is hypothesized that implementation of the disease management process will improve the percentage of diabetic individuals attaining all three therapeutic targets (HgbA1C\<8.0%, LDL\<100mg/dl, and BP\<130/80mmHG) by 10% compared to usual care.


Options:
A: Hemoglobin A1c (Baseline, 6 months)
B: HbA1c (6 months)
C: The percentage of participants reaching target control of HbA1c (7.0), and blood pressure (<140/80) and cholesterol (<4 mmol/l), (18 months)
D: Combined outcome of BP<130/80 mmHG, HgbA1C<8%, and LDL<100mg/dl at 1 year; the primary analysis will compare the intervention to usual care with respect to the percentage of diabetic individuals achieving all three therapeutic goals (one year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Care Management on Diabetes Outcomes
Brief Summary: The purpose of the study is to determine if a nurse managed, protocol driven, disease management process for diabetes results in improved attainment of therapeutic goals for diabetes compared to usual care. It is hypothesized that implementation of the disease management process will improve the percentage of diabetic individuals attaining all three therapeutic targets (HgbA1C\<8.0%, LDL\<100mg/dl, and BP\<130/80mmHG) by 10% compared to usual care.


Options:
A: Predicted 10-year CHD risk (4-month follow-up)
B: Combined outcome of BP<130/80 mmHG, HgbA1C<8%, and LDL<100mg/dl at 1 year; the primary analysis will compare the intervention to usual care with respect to the percentage of diabetic individuals achieving all three therapeutic goals (one year)
C: Change in serum LDL-cholesterol level (at 6 months post disclosure of CAD risk)
D: Low-density Lipoprotein Cholesterol (Measured at 1 year); Systolic Blood Pressure (Measured at 1 year); HbA1c (Measured at 1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Care Management on Diabetes Outcomes
Brief Summary: The purpose of the study is to determine if a nurse managed, protocol driven, disease management process for diabetes results in improved attainment of therapeutic goals for diabetes compared to usual care. It is hypothesized that implementation of the disease management process will improve the percentage of diabetic individuals attaining all three therapeutic targets (HgbA1C\<8.0%, LDL\<100mg/dl, and BP\<130/80mmHG) by 10% compared to usual care.


Options:
A: Percentage of Participans With A1c<7%, LDL Cholesterol <100mg/dL, Systolic Blood Pressure <130mm Hg and Diastolic Blood Pressure <80 mm Hg (4 months)
B: Combined outcome of BP<130/80 mmHG, HgbA1C<8%, and LDL<100mg/dl at 1 year; the primary analysis will compare the intervention to usual care with respect to the percentage of diabetic individuals achieving all three therapeutic goals (one year)
C: Blood pressure control (Measured by zero blood pressure measurements at baseline and 2, 4, 6, 8, and 9 months)
D: Anticoagulation-related quality of life (Four months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Microvascular Coronary Disease In Women: Impact Of Ranolazine
Brief Summary: 1. To evaluate the impact of ranolazine extended-release tablets in women with subendocardial ischemia due to microvascular endothelial dysfunction on myocardial ischemia (Cardiac Magnetic Resonance (CMR) extent, severity.
2. To evaluate the impact of ranolazine extended-release tablets in women with subendocardial ischemia due to microvascular endothelial dysfunction on the outcomes of angina (Seattle Angina Questionnaire (SAQ), WISE angina frequency, Duke Activity Status Inventory(DASI) and SF-36).


Options:
A: N/A
B: Cardiac Magnetic Resonance (CMRs) (4 weeks and 10 weeks)
C: Seattle Angina Questionnaire (SAQ) (2 weeks (first intervention) and 6 weeks (second intervention))
D: Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization (Baseline through end of study (average 90 weeks))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Trial to Reduce IDDM in the Genetically at Risk (TRIGR): the Pilot Study
Brief Summary: The overall objective of the study is to assess whether complete avoidance of cow's milk (CM) proteins, for at least the first 6 months of life, prevents type 1 diabetes (insulin-dependent diabetes mellitus, IDDM) in genetically susceptible children who have a mother, biological father or sibling affected by type 1 diabetes.


Options:
A: infants' intake, length of feeding and patterning of feeding of Nutramigen relative to Enfamil (infant-led feeding condition) (0.5-8.5 months)
B: Beta-cell autoantibodies (3,6,12,24,36,48,60,72 months)
C: Positivity for two or more diabetes-associated autoantibodies and/or clinical type 1 diabetes (10 years)
D: Number of Participants With Type 1 Diabetes Mellitus (12 and 18 months and annually from 2 years up to 14 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Trial to Reduce IDDM in the Genetically at Risk (TRIGR): the Pilot Study
Brief Summary: The overall objective of the study is to assess whether complete avoidance of cow's milk (CM) proteins, for at least the first 6 months of life, prevents type 1 diabetes (insulin-dependent diabetes mellitus, IDDM) in genetically susceptible children who have a mother, biological father or sibling affected by type 1 diabetes.


Options:
A: Positivity for two or more diabetes-associated autoantibodies and/or clinical type 1 diabetes (10 years)
B: Number of Participants With Type 1 Diabetes Mellitus (12 and 18 months and annually from 2 years up to 14 years)
C: Growth (weight) (106 days)
D: infants' intake, length of feeding and patterning of feeding of Nutramigen relative to Enfamil (infant-led feeding condition) (0.5-8.5 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Trial to Reduce IDDM in the Genetically at Risk (TRIGR): the Pilot Study
Brief Summary: The overall objective of the study is to assess whether complete avoidance of cow's milk (CM) proteins, for at least the first 6 months of life, prevents type 1 diabetes (insulin-dependent diabetes mellitus, IDDM) in genetically susceptible children who have a mother, biological father or sibling affected by type 1 diabetes.


Options:
A: Number of Participants With Type 1 Diabetes Mellitus (12 and 18 months and annually from 2 years up to 14 years)
B: Positivity for two or more diabetes-associated autoantibodies and/or clinical type 1 diabetes (10 years)
C: Beta-cell autoantibodies (3,6,12,24,36,48,60,72 months)
D: infants' intake, length of feeding and patterning of feeding of Nutramigen relative to Enfamil (infant-led feeding condition) (0.5-8.5 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Placebo-Controlled, Enriched-Enrollment, Randomized Withdrawal Study to Evaluate an Optimal Methodology for Conducting Proof of Concept Trials in Patients With Chronic Neuropathic Pain Syndromes Using Pregabalin as a Test Drug
Brief Summary: The purpose of this study is to determine the best way to conduct clinical trials in patients with neuropathic pain (nerve pain). This study will see if generic pregabalin has any effect on neuropathic pain.


Options:
A: Daily Pain Rating Scale (DPRS)- Mean Pain Score (ITT Population) (Endpoint- Week 8 or Early Discontinuation)
B: Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at End of Maintenance Treatment (EOMT) Using Last Observation Carried Forward (LOCF) Data (Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit))
C: Daily Evening Patient Reported Pain Intensity Scores (Baseline and 6 Weeks)
D: Average Diabetic Peripheral Neuropathy (DPN) Pain Based on a Numeric Rating Scale (NRS) Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period) (End of Period (includes both Visits 5 and 9))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Continuous Versus Cyclic Use of Combined Oral Contraceptive Pills
Brief Summary: The primary objective is to determine if continuous COC use leads to higher continuation rates over 12 months of follow up than use of the standard 28-day COC regimen.


Options:
A: Discontinuation rate by treatment group (at 12 months)
B: 12 month cumulative COC discontinuation probabilities (12 months)
C: Adherence Rate (Rate of Perfect Method Use) (For the first 3 months)
D: Pearl Index (Up to 1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Metformin HCl in Combination With Colesevelam HCl, Compared to Metformin HCl Alone, as Initial Therapy in Drug naïve Subjects With Type 2 Diabetes Mellitus, and the Effects of Colesevelam HCl on the Lipid Profile in Subjects With Pre Diabetes
Brief Summary: This is a 16-week double-blind, placebo-controlled (for colesevelam hydrochloride (HCl)) study in the type 2 diabetic subjects and pre-diabetic subjects. Diabetic participants will also be treated with open label, background,metformin HCl. Two-hundred sixty subjects with type 2 diabetes (T2DM) and 200 pre-diabetic subjects are planned to be be enrolled. Qualified subjects with T2DM will be randomized 1:1 to receive metformin HCl plus colesevelam HCl or metformin HCl plus placebo matching colesevelam HCl. Qualified pre-diabetic subjects will be randomized 1:1 to receive colesevelam HCl or matching placebo.


Options:
A: To assess the additional lowering of HbA1C achieved by addition of colesevelam hydrochloride to current antidiabetic therapy
B: Percent Change of Hemoglobin A1C (HbA1C) From Baseline to 16 Weeks When Given as Initial Therapy to Drug-naïve, Diabetic Subjects. (Baseline to 16 weeks); Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) in Pre-Diabetic Subjects From Baseline to 16 Weeks (Baseline to 16 Weeks)
C: Composite of non-fatal stroke, non-fatal myocardial infarction or death from any cardiovascular cause (July 2001 - December 2007); Composite of new or substantially worsening nephropathy or microvascular eye disease. (July 2001 - December 2007)
D: - To assess the additional lowering of HbA1c achieved by; addition of WelChol® to current antidiabetic therapy

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo Controlled, Multicentre Study to Determine the Effect of QVA149 on Lung Function in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: This study will evaluate the safety and efficacy of QVA149 in patients with moderate to severe COPD.


Options:
A: Number of Participants With Any On-treatment Adverse Event (AE) or Any Serious Adverse Event (SAE) (From the start of study drug up to 52 weeks)
B: Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 7 (Baseline, Day 7)
C: Change From Baseline in 1-hour Morning Post-dose Forced Expiratory Volume in One Second (FEV1) (Baseline and Week 24); Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1) (Baseline and Week 24)
D: Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (0-3h) Response on Day 169. (1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 169.); Trough FEV1 Response on Day 170. (1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 23 h and at 23 h 50 min after inhalation of study medication on Day 170); Saint George's Respiratory Questionnaire (SGRQ) Total Score on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287) (Day 169)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase II Trial Of Sunitinib Administered Daily For 4 Weeks, Followed By 2-Week Rest Vs. 2-Week On And 1-Week Off In Metastatic Renal Cell Carcinoma
Brief Summary: This study is to evaluate the efficacy, safety, and feasibility of sunitinib in 4/2 and 2/1 regimen in previously untreated metastatic RCC to select the most promising regimen, which should be used in further studies of this patient population.


Options:
A: Overall Survival (OS) at Primary Endpoint (Randomization until 398 deaths, up to May 2015 (approximately 30 months))
B: Treatment failure rate (progressive disease, treatment withdrawal due to unacceptable toxicities, or any death) (12 months)
C: Anti-tumor Activity as Measured by Median Progression Free Survival Time (24 Months)
D: Progression-free Survival (PFS) by Independent Imaging Review (IIR) (From the date of randomization to the date of the first documentation of PD or date of death, whichever occurred first or up to data cutoff date 28 Aug 2020 (up to approximately 46 months))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Supplementation With 2000 International Units (IU) Vitamin D, 1gm Calcium or Both on Calcium Absorption and Bone Mineralization in Children With Juvenile Rheumatoid Arthritis
Brief Summary: 2000 international units (IU) vitamin D, 1 gram (gm) calcium, or both given to children with Juvenile Rheumatoid Arthritis (JRA) may increase percent true calcium absorption, bone mineral turnover and/or bone mineralization.


Options:
A: Number of children dying during the study period; Average weight gain in each of the treatment groups
B: Percent true calcium absorption (After 6 months of treatment)
C: Change in CD4 percent associated with vitamin D supplementation in HIV-infected children (6 months)
D: All-cause mortality and diarrheal morbidity (age 6 weeks to age 24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Target-Controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by the Index Bispectral: Comparison Between Manual Perfusion and Automated Perfusion During Rigid Bronchoscopy
Brief Summary: The purpose of this study is to compare manual administration of propofol and remifentanil and dual closed-loop using bispectral index as the control variable during rigid bronchoscopy.


Options:
A: evaluation of intra-operative awareness in all the patients investigated (within 4 days after the general anesthesia)
B: The incidence of explicit recall of events during the surgical and anesthetic periods. (30 days)
C: Percentage of time with BIS in the desired range (During the procedure)
D: electroencephalographic (BIS) and functional cognitive recovery (24h)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Study Comparing Tissue Conservation in Conventional Versus Mohs' Surgery of Basal Cell Carcinoma
Brief Summary: We have compared to types of surgery to assess which one leaves the smaller surgical defect.


Options:
A: defect size after surgery (immediately after surgery)
B: Objective Response (OR) Determined by the Independent Review Facility (From study initiation (enrollment of first patient) through 9 months following the first treatment of the last enrolled patient (clinical cutoff date of 26 November 2010), up to 90 weeks)
C: Absence of local recurrence at 3 years after start of treatment
D: Objective Response Rate (ORR) Based on Central Review According to mRECIST (for Locally Advanced Basal Cell Carcinoma (laBCC)) and RECIST 1.1 (for Metastatic Basal Cell Carcinoma (mBCC)) Per Primary Efficacy Analysis Set (pEAS) (6 months); Objective Response Rate (ORR) Based on Central Review According to mRECIST (for Locally Advanced Basal Cell Carcinoma (laBCC)) and RECIST 1.1 (Metastatic Basal Cell Carcinoma (mBCC)) Per Full Analysis Set (FAS) (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Culturally Sensitive Depression Care Management for Latino Primary Care Patients
Brief Summary: The purpose of this study is to determine whether telephonic depression care management can improve depression outcomes for Latino primary care patients who are enrolled in Medicaid and are receiving an antidepressant from their primary care doctor.


Options:
A: Compare the effectiveness of a culturally tailored intervention with the effectiveness of a standard intervention by evaluating its impact on patient outcomes (remission of depression, depression symptom level, functional status) at 6 and 12 months.
B: Quick Inventory of Depressive Symptomatology - Clinician Administered (QIDS-C) (3 months)
C: Reduction in symptoms of major depression (Measured at Months 12, 18, and 24)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Continuous Infusion of Fentanyl for Pain Control in Preterm Newborn on Mechanical Ventilation
Brief Summary: The objective of this randomized, double-blind trial is to compare the efficacy and safety of 2 therapeutic regimens of fentanyl administration in a population of preterm newborns of GA \<= 32 weeks in MV:

* Group A) continuous infusion of Fentanyl + open label boluses of Fentanyl;
* Group B) continuous infusion of placebo + open label boluses of Fentanyl.


Options:
A: Ductus diameter mm/kg (at postnatal age of 5 days); Cumulative dosage of morphine (at postnatal age of 5 days)
B: Neonatal Composite Outcome (72 hours of life)
C: Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity) (Birth to 28 days)
D: The primary efficacy variable for this study will be the pain scores obtained during the study period. Procedural pain will be measured once a day by the PIPP scale. Chronic pain will be evaluated through the application of the EDIN scale 3 times a day. (7 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Randomized, Parallel-group Efficacy and Safety Study for the Prevention of Venous Thromboembolism in Hospitalized Medically Ill Patients Comparing Rivaroxaban With Enoxaparin. The MAGELLAN Study
Brief Summary: This study will evaluate if extended therapy with oral rivaroxaban can prevent blood clots in the leg and lung that can occur with patients hospitalized for acute medical illness, and compare these results with those of the standard enoxaparin dose and duration regimen. The safety of rivaroxaban will also be studied.


Options:
A: acomposite of mortality, nonfatal myocardial infarction and nonfatal stroke (30 months intake; 12-42 months follow-up)
B: Event Rate of All-Cause Mortality, Myocardial Infarction (MI), or Stroke (Up to Global treatment end date (approximately 54 months)); Event Rate of Either Fatal Bleeding or Bleeding Into a Critical Space With Potential for Permanent Disability (Up to 227 Weeks)
C: Percentage of Participants With Composite Endpoint of Venous Thromboembolism [VTE] (Any Deep Vein Thrombosis [DVT], Non Fatal Pulmonary Embolism [PE]) and VTE-related Death up to Day 35 + 6 Days (Up to Day 35 + 6 days); Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days (Up to Day 10 + 5 days)
D: Event Rate Per 100 Patient Years for Composite Endpoint of Ischemic Stroke, Intracerebral Hemorrhage, or Death (From date of randomization until the date of the first to occur of ischemic stroke, intracerebral hemorrhage, or death, up to 6 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Randomized, Parallel-group Efficacy and Safety Study for the Prevention of Venous Thromboembolism in Hospitalized Medically Ill Patients Comparing Rivaroxaban With Enoxaparin. The MAGELLAN Study
Brief Summary: This study will evaluate if extended therapy with oral rivaroxaban can prevent blood clots in the leg and lung that can occur with patients hospitalized for acute medical illness, and compare these results with those of the standard enoxaparin dose and duration regimen. The safety of rivaroxaban will also be studied.


Options:
A: During double blind treatment : Cumulative occurrence of VTE assessed by ultrasound for all patients at 28±4 days after randomization (or earlier if symptomatic VTE) and/or V/Q lung scan for symptomatic patients ; Major hemorrhagic complications.
B: Cumulative occurrence of VTE events (deep-vein thrombosis, pulmonary embolism) (10 ± 4 days following acute ischemic stroke)
C: Percentage of Participants With Composite Endpoint of Venous Thromboembolism [VTE] (Any Deep Vein Thrombosis [DVT], Non Fatal Pulmonary Embolism [PE]) and VTE-related Death up to Day 35 + 6 Days (Up to Day 35 + 6 days); Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days (Up to Day 10 + 5 days)
D: Safety of nadroparine or heparin (DAY 3,7,30,90); Efficacy of nadroparine or heparin (DAY 3,7, 30, 90)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Randomized, Parallel-group Efficacy and Safety Study for the Prevention of Venous Thromboembolism in Hospitalized Medically Ill Patients Comparing Rivaroxaban With Enoxaparin. The MAGELLAN Study
Brief Summary: This study will evaluate if extended therapy with oral rivaroxaban can prevent blood clots in the leg and lung that can occur with patients hospitalized for acute medical illness, and compare these results with those of the standard enoxaparin dose and duration regimen. The safety of rivaroxaban will also be studied.


Options:
A: During double blind treatment : Cumulative occurrence of VTE assessed by ultrasound for all patients at 28±4 days after randomization (or earlier if symptomatic VTE) and/or V/Q lung scan for symptomatic patients ; Major hemorrhagic complications.
B: Incidence of venous thromboembolism during treatment (proximal deep vein thrombosis, pulmonary embolism, death related to venous thromboembolism) (20 days)
C: Percentage of Participants With Composite Endpoint of Venous Thromboembolism [VTE] (Any Deep Vein Thrombosis [DVT], Non Fatal Pulmonary Embolism [PE]) and VTE-related Death up to Day 35 + 6 Days (Up to Day 35 + 6 days); Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days (Up to Day 10 + 5 days)
D: Incidence of Composite of Adjudicated Total Venous Thromboembolism (VTE) and VTE-related Death During the Intended Treatment Period - Primary Efficacy Population (Intended Treatment Period); Incidence of Major Bleeding During the Treatment Period in Treated Participants (Day 1, first dose of study drug, to last dose of study drug plus 2 days); Incidence of Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants (Day 1, first dose of study drug, to last dose of study drug plus 2 days); Incidence of Composite of Major or Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants (Day 1, first dose of study drug, to last dose of study drug plus 2 days); Incidence of All Bleeding During the Treatment Period in Treated Participants (Day 1, first dose of drug to last dose of drug plus 2 days)

Answer: C