TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Open Label Phase II Study of Weekly Gemcitabine Plus Pazopanib Versus Weekly Gemcitabine Alone in the Treatment of Patients With Persistent or Relapsed Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma
Brief Summary: Ovarian cancer is the leading cause of gynecologic cancer deaths, and the fifth most common cause of cancer deaths in women. While approximately 75% of patients with epithelial ovarian cancer will respond to first-line chemotherapy with platinum and paclitaxel, most patients with advanced stage epithelial ovarian cancer will experience disease recurrence. Pazopanib is a novel agent has recently been approved for the treatment of subjects with advanced renal cell carcinoma (RCC), and preclinical studies suggest it may be effective in other cancers such as ovarian cancer. Therefore, the purpose of this study is to test the efficacy and safety of a novel agent, pazopanib, as an adjunct to a standard treatment, gemcitabine, for recurrent or persistent ovarian cancer. This is an open label study in which subjects will be randomized 1:1 to receive 4 cycles of either gemcitabine, or gemcitabine with pazopanib. Gemcitabine will be administered as an IV infusion weekly on days 1 and 8 of a 21 day cycle. Subjects randomized to receive pazopanib will take 800 mg daily during the 21 day cycle. All subjects will be monitored for toxicity and other indicators of safety (labs, physical exams, vitals) at intervals throughout the treatment cycles. Subjects will be followed for up to 5 years following the conclusion of treatment to evaluate efficacy. The primary endpoints of the study are progression free survival and overall survival, which will be assessed at three years.


Options:
A: ORR (Up to 2 years); PFS (Up to 2 years)
B: Peritoneal adhesion ORR (pORR) (3weeks after the last treatment)
C: Progression Free Survival (PFS) (Assessed frequently during the trial until observation of 586 PFS events or three years after Last Patient In, whichever occurs earlier)
D: Progression-free Survival (3 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Center for Advancing Equity in Clinical Preventive Services Project 2: Reducing Disparities in Primary Prevention of Cardiovascular Disease
Brief Summary: Cardiovascular disease (CVD) is the leading cause of disparities in years of life lost by race and low socioeconomic status. Statins have been shown to decrease the risk of cardiovascular events among individuals with high CVD risk. Yet, despite increased statin use and overall declining CVD rates, disparities in statin use and disparities in the control of high cholesterol by race, ethnicity, and socioeconomic status have persisted.

Objective: To improve the appropriate use of statins for primary cardiovascular disease prevention among high risk individuals at community health centers through a system of population health management that uses electronic health record (EHR) data to identify patients for targeted education and outreach.

Aim 1: Conduct a randomized controlled trial among individuals with 10-year risk for myocardial infarction or coronary death of 10% or higher to determine if the population health management intervention, compared to usual care, results in higher rates of documented statin treatment discussions within 6 months (primary process outcome), higher rates of statin prescribing within 6 months (secondary process outcome), and higher rates of significant low-density lipoprotein cholesterol (LDL-C) lowering defined as a follow up LDL-C ≥30 mg/dL lower than baseline (primary clinical outcome).

Aim 2: Interview patients who received the intervention to identify barriers to success

Aim 3: Assess the overall costs of the intervention and the costs per each patient who achieves significant LDL-C lowering compared to patient who received usual care.


Options:
A: Incidence of CHD and other lifestyle related diseases after ten years (2012)
B: Discussion between provider and patient about statin treatment (within 6 months of randomization)
C: Greater reduction in CHD risk in case group vs. control (6 months)
D: The mean percent of applicable Guideline Advantage standards of care that are met at 12 months (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Expecting Success: Personalized Management of Body Weight During Pregnancy
Brief Summary: The purpose of this study is to determine how to help manage weight gain during pregnancy. This study is part of the National Consortium 'LIFE-Moms: Lifestyle interventions in expectant moms'. LIFE-Moms is 7 studies funded to test different lifestyle interventions in overweight and obese pregnant women.


Options:
A: Short-term Exclusive Breastfeeding (24-hour recall) (Measured at 1 month post-delivery via tablet based survey AND independent verification phone survey within one week); Long-term Exclusive Breastfeeding (24-hour recall) (Measured at 5 months post-delivery via tablet based survey AND independent verification phone survey within one week)
B: Count of Women Who Have Excess Gestational Weight Gain (Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation))
C: Highly-effective contraceptive use (6 months postpartum)
D: Smoking Abstinence (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Expecting Success: Personalized Management of Body Weight During Pregnancy
Brief Summary: The purpose of this study is to determine how to help manage weight gain during pregnancy. This study is part of the National Consortium 'LIFE-Moms: Lifestyle interventions in expectant moms'. LIFE-Moms is 7 studies funded to test different lifestyle interventions in overweight and obese pregnant women.


Options:
A: Count of Women Who Have Excess Gestational Weight Gain (Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation))
B: Gestational Weight Gain (Delivery)
C: Child body mass standard deviation score (On average 2.9 years of age)
D: The investigators primary outcome is the rate of adherence to the IOM guidelines between our study groups. (3 - 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Expecting Success: Personalized Management of Body Weight During Pregnancy
Brief Summary: The purpose of this study is to determine how to help manage weight gain during pregnancy. This study is part of the National Consortium 'LIFE-Moms: Lifestyle interventions in expectant moms'. LIFE-Moms is 7 studies funded to test different lifestyle interventions in overweight and obese pregnant women.


Options:
A: Attendance at Cervical Cancer Screening at clinics included in Trial (within 60 days from recruitment into study)
B: HIV propensity score (0, 6 and 12 months)
C: Count of Women Who Have Excess Gestational Weight Gain (Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation))
D: contraceptive continuation (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Expecting Success: Personalized Management of Body Weight During Pregnancy
Brief Summary: The purpose of this study is to determine how to help manage weight gain during pregnancy. This study is part of the National Consortium 'LIFE-Moms: Lifestyle interventions in expectant moms'. LIFE-Moms is 7 studies funded to test different lifestyle interventions in overweight and obese pregnant women.


Options:
A: Adherence to ART via report on visual analogue scale (prior 30 days)
B: Smoking Abstinence (3 months)
C: Mammogram receipt (1 week)
D: Count of Women Who Have Excess Gestational Weight Gain (Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Expecting Success: Personalized Management of Body Weight During Pregnancy
Brief Summary: The purpose of this study is to determine how to help manage weight gain during pregnancy. This study is part of the National Consortium 'LIFE-Moms: Lifestyle interventions in expectant moms'. LIFE-Moms is 7 studies funded to test different lifestyle interventions in overweight and obese pregnant women.


Options:
A: Count of Women Who Have Excess Gestational Weight Gain (Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation))
B: Smoking Abstinence (3 months)
C: Initiation of Long acting reversible contraception method (6 months)
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: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Expecting Success: Personalized Management of Body Weight During Pregnancy
Brief Summary: The purpose of this study is to determine how to help manage weight gain during pregnancy. This study is part of the National Consortium 'LIFE-Moms: Lifestyle interventions in expectant moms'. LIFE-Moms is 7 studies funded to test different lifestyle interventions in overweight and obese pregnant women.


Options:
A: Percent of children immunized (Up to 12 months of age)
B: Effect of SMS intervention on attendance rate to follow-up screening appointment (up to 14 months)
C: Neonatal death (28 days)
D: Count of Women Who Have Excess Gestational Weight Gain (Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II, Randomised, Placebo Controlled, Multicentre, Feasibility Study of Low Dose (Metronomic) Cyclophosphamide With and Without Nintedanib (BIBF 1120) in Advanced Ovarian Cancer
Brief Summary: The primary objective is to explore the efficacy and safety of an all oral combination of BIBF 1120 (an inhibitor of angiogenic signalling) and metronomic cyclophosphamide in patients with multiply-relapsed advanced ovarian cancer, who have completed a minimum of two lines of previous chemotherapy and who for any reason are not suitable for further 'standard' intravenous chemotherapy treatments.


Options:
A: 90% confidence interval of the relative mean Cmax, AUC0-t, AUC0-∞, of the test and reference product (2 cycles)
B: Progression-free Survival (PFS) According to RECIST v1.1 in Molecularly-defined HRD (Homologous Recombination Deficiency) Subgroups (Part 1 of Study) (Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.); Objective Response Rate (ORR) by RECIST v1.1 in Molecularly-defined HRD Subgroups (Part 2 of Study) (Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.)
C: Overall survival (After follow-up is complete (year 3-4 of the trial))
D: Progression-free survival

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II, Randomised, Placebo Controlled, Multicentre, Feasibility Study of Low Dose (Metronomic) Cyclophosphamide With and Without Nintedanib (BIBF 1120) in Advanced Ovarian Cancer
Brief Summary: The primary objective is to explore the efficacy and safety of an all oral combination of BIBF 1120 (an inhibitor of angiogenic signalling) and metronomic cyclophosphamide in patients with multiply-relapsed advanced ovarian cancer, who have completed a minimum of two lines of previous chemotherapy and who for any reason are not suitable for further 'standard' intravenous chemotherapy treatments.


Options:
A: Progression-free Survival (PFS) (From randomization until evidence of progressive disease or death, whichever occurred first (average of 15.2 months))
B: Objective Response Rate (ORR) - LEAD IN STAGE, RDT Cohorts and NRE Ovarian Cohort Only (From initial dose through final study visit up to 44 months); Bone Scan Response (BSR) - NRE, CRPC (From initial dose through final study visit up to 15 months); Progression-Free Survival (PFS) - Randomized Stage, RDT Cohorts Only (From initial dose through final study visit up to 44 months)
C: Overall survival (After follow-up is complete (year 3-4 of the trial))
D: Event Free Survival (The duration of time from study entry to time to progression or death,or begining a subsequent therapy, whichever occurs first, assessed up to 32 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II, Randomised, Placebo Controlled, Multicentre, Feasibility Study of Low Dose (Metronomic) Cyclophosphamide With and Without Nintedanib (BIBF 1120) in Advanced Ovarian Cancer
Brief Summary: The primary objective is to explore the efficacy and safety of an all oral combination of BIBF 1120 (an inhibitor of angiogenic signalling) and metronomic cyclophosphamide in patients with multiply-relapsed advanced ovarian cancer, who have completed a minimum of two lines of previous chemotherapy and who for any reason are not suitable for further 'standard' intravenous chemotherapy treatments.


Options:
A: Disease Progression According to RECIST Version 1.1, as Assessed by the Investigator, or Death From Any Cause (Investigator Progression Free Survival as Per invPFS) (Every 12 calendar weeks (within 7 days prior is permitted) after start of treatment until treatment discontinuation due to disease progression. Total follow-up was up to approximately 3 years.)
B: Progression Free Survival (PFS) - in non-tBRCA HRD positive patients (Approximately 4 years); Progression Free Survival (PFS) - in all non-tBRCA patients (Approximately 4 years)
C: Efficacy by progression free survival (PFS1) (phase up to a total of 15 months)
D: Overall survival (After follow-up is complete (year 3-4 of the trial))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-blind, Placebo-controlled Phase 3 Study of Ibrutinib, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Combination With Bendamustine and Rituximab (BR) in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Brief Summary: The purpose of this study is to examine the safety and efficacy of Ibrutinib administered in combination with bendamustine and rituximab in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).


Options:
A: Progression-free Survival (PFS) (Up to 5 years)
B: N/A
C: Progression-free Survival (PFS) as Assessed by Independent Review Committee (IRC) (From the randomization date up to 60 months post the randomization date.)
D: Overall response rate (ORR) (84 days after start of the last induction cycle)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Randomized, Placebo-controlled, Double Blind Study of Venlafaxine to Prevent Oxaliplatin-Induced Neuropathy
Brief Summary: You are being asked to take part in this research study because you are going to be treated with oxaliplatin chemotherapy as part of your standard care. Oxaliplatin commonly causes neuropathy (numbing, tingling and/or pain).The purpose of this study is to compare the effects, good and/or bad, of venlafaxine with a placebo (an inactive agent) on oxaliplatin-induced neuropathy (numbing, tingling and/or pain)


Options:
A: Cycle 1 Sensory Neuropathy Score (Items 31-36, 39, 40 and 48) of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-CIPN20 (Up to 2 weeks)
B: HADS Anxiety (2-4 weeks prior to drug administration); HADS Anxiety (1 day prior to drug administration 1); HADS Anxiety (1 day post drug administration 1); HADS Anxiety (6 weeks post drug administration 1); HADS Anxiety (1 day prior to drug administration 2); HADS Anxiety (6 weeks post drug administration 2); HADS Anxiety (26 weeks post drug administration 2); State-Trait Anxiety Inventory (STAI) State (2-4 weeks prior to drug administration/ Baseline); STAI State (1 day prior to drug administration 1); STAI State (1 day post drug administration 1); HADS Depression (2-4 weeks prior to drug administration/ Baseline); STAI State (6 weeks post drug administration 1); STAI State (1 day prior to drug administration 2); STAI State (1 day post drug administration 2); STAI State (6 weeks post drug administration 2); STAI State (26 weeks post drug administration 2); STAI Trait (2-4 weeks prior to drug administration/ Baseline); STAI Trait (1 day prior to drug administration 1); STAI Trait (1 day post drug administration 1); STAI Trait (6 weeks post drug administration 1); STAI Trait (1 day prior to drug administration 2); STAI Trait (1 day post drug administration 2); STAI Trait (6 weeks prior to drug administration 2); STAI Trait (6 weeks post drug administration 2); HADS Depression (1 day prior to drug administration 1); HADS Depression (1 day post drug administration 1); HADS Depression (6 weeks post drug administration 1); HADS Anxiety (1 day post drug administration 2); HADS Depression (1 day post drug administration 2); HADS Depression (6 weeks post drug administration 2); HADS Depression (26 weeks post drug administration 2)
C: GRID-HAM-D-17 -- Structured Interview Guide for the Hamilton Depression Scale. (Baseline, 5 weeks post session 1 and 2, 6-month follow-up); HAM-A Assessed With the SIGH-A -- a Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A). (Baseline, 5 weeks post session 1 and 2, 6-month follow-up)
D: Hot Flash Symptom Severity Score (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Randomized, Placebo-controlled, Double Blind Study of Venlafaxine to Prevent Oxaliplatin-Induced Neuropathy
Brief Summary: You are being asked to take part in this research study because you are going to be treated with oxaliplatin chemotherapy as part of your standard care. Oxaliplatin commonly causes neuropathy (numbing, tingling and/or pain).The purpose of this study is to compare the effects, good and/or bad, of venlafaxine with a placebo (an inactive agent) on oxaliplatin-induced neuropathy (numbing, tingling and/or pain)


Options:
A: serial dexamethasone/CRH tests (week 0, 1, and 5)
B: Overall Response Rate (ORR) (6 weeks)
C: Hot Flash Symptom Severity Score (12 weeks)
D: Cycle 1 Sensory Neuropathy Score (Items 31-36, 39, 40 and 48) of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-CIPN20 (Up to 2 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Redesigning Medication Intensification Effectiveness Study for Diabetes
Brief Summary: The proposed research study aims to determine whether applying the University of Pittsburgh Medical Center Nurse-Directed Diabetes Management Protocols (NDMPs) leads to improved clinical outcome and process measures as recommended by American Diabetes Association (ADA), quality of life, treatment satisfaction and medication adherence for adults with diabetes, and favorable providers' satisfaction as compared to usual diabetes care. Furthermore, the cost-effectiveness of performing the NDMPs compared to usual diabetes care in primary care settings will also be assessed.


Options:
A: Change in systolic blood pressure; change in Hemoglobin A1C; change in low density lipoprotein (12 months)
B: Patients Indicated for ACE/ARB and Statin Who Had an Active Prescription for Both (Percent of clinic patients prescribed guideline-concordant cardioprotective medications, as of the 1st day of each month, from up to 36 months)
C: Change in HbA1c (12 Months)
D: Glycated hemoglobin (A1C) (1 year); Blood pressure (systolic and diastolic blood pressure (1 year); Lipids (LDLc, HDLc, cholesterol, and triglyceride) (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimal Timing of Foley Catheter Removal in Patients Undergoing Thoracic Surgery With Epidural Analgesia: A Randomized, Controlled Trial
Brief Summary: Is the early removal of Foley catheter safe in patients undergoing general thoracic surgery with an epidural catheter in place?


Options:
A: Need for insertion of catheter after Foley removed. (participants will be followed for the duration of hospital stay, an expected average of 5 weeks)
B: Hospital stay (4 weeks)
C: Number of Participants With Acute Urinary Retention (Postoperative day 1 or postpoperative 3 depending on group randomization)
D: time to return of normal bladder function (5 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Profilo Degli Acidi Grassi Omega-3 Dei Globuli Rossi in Neonati Sani Alimentati Con Una Formula Per l'Infanzia Contenente Una Miscela di Grassi Del Latte e Oli Vegetali
Brief Summary: The objective of this study is to determine whether the use of a mix of dairy lipids and plant oils in infant formula can increase the sum of omega-3 fatty acids levels in membrane phospholipids of red blood cells (RBC) in 4 month-old infants compared with a formula containing only lipids of plant origin.


Options:
A: amount of fat mass in the offspring (at birth, 6 weeks, 4 months, 1 year postpartum)
B: Average duration of exposure to PN (including Intralipid, IL) between the initial feeding and bowel reanastomosis (up to three years)
C: Sum of omega-3 fatty acid levels in membrane phospholipids of RBC (after 4 months of consumption)
D: visual development

Answer: C