TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Stepped Wedge Trial of an Intervention to Support Proxy Decision Makers in ICUs
Brief Summary: This is a stepped wedged randomized controlled trial comparing the PARTNER intervention with usual care in 5 Intensive Care Units. The overarching goal of this research project to ensure patient-centered decisions about the use of intensive treatments for patients with advanced critical illness. In a prior project, the investigators developed the PARTNER program (PAiring Re-engineered ICU Teams with Nurse-driven Education and OutReach), a 4-facet, team-based intervention that re-engineers how surrogates are supported in ICUs, including: 1) changing care "defaults" to ensure clinician-family meetings within 48 hours of enrollment and frequently thereafter; 2) protocolized, nurse-administered coaching and emotional support of surrogates before and during clinician-family meetings, 3) increased use of palliative care services for patients with a poor prognosis. The investigators propose to begin deployment of the PARTNER II program in the spring of 2015 enrolling 690 surrogate decision makers in 5 ICUs using a stepped wedge design. The investigators expect to achieve the following project goals:

1. To increase the patient-centeredness of end-of-life decisions, and to increase the quality of clinician-family communication.
2. To decrease the psychological burden on family members acting as surrogates.
3. To reduce total health care costs by decreasing the duration of use of burdensome, invasive treatments at the end of life.


Options:
A: Decision support quality audit using simulated patients measured by the validated and reliable Decision Support Analysis Tool (6 month)
B: Occurrence of Discussion About Goals of Care at Target Visit (2 weeks after target visit)
C: Quality of Communication (QOC) scale (At 6 months)
D: Place of care and death (Up to 4.5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Phase 3 Trial of Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer: ENZAMET
Brief Summary: The purpose of this study is to determine the effectiveness of enzalutamide, versus a conventional non-steroidal anti androgen (NSAA), when combined with a luteinizing hormone releasing hormone analog (LHRHA) or surgical castration, as first line androgen deprivation therapy (ADT) for newly diagnosed metastatic prostate cancer.


Options:
A: Overall Survival (Up to 60 months)
B: Overall survival (1:Not applicable)
C: Overall Survival Time (3 years)
D: Overall Survival (From randomization (Day 1) up to end of study (Month 60)); Radiographic Progression-free Survival (rPFS) (From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 6-month, Open Label, Randomised, Efficacy Study to Evaluate Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) Inhalation Powder Delivered Once Daily Via the Dry Powder Inhaler ELLIPTA™ Compared With Usual ICS/LABA Maintenance Therapy Delivered by Dry Powder Inhaler in Subjects With Persistent Asthma
Brief Summary: The combination of FF, an ICS and VI, an orally inhaled LABA has been developed as a once-daily combination therapy for the long-term maintenance treatment of asthma in adults and children \>=12 years of age. Pivotal phase III studies have demonstrated the safety and efficacy of FF/VI in asthma. However, it is increasingly acknowledged that randomised clinical trials tend to be highly controlled and enrol a more highly selected subject population than is expected to be prescribed the medication post-approval. There is a need for data in a more representative population in close to a 'real life' conditions, where physicians have the ability to choose the best treatment in their view for any individual subject and adapt treatments to subjects' characteristics and response. This multi-center, open-label, randomized, parallel group study will evaluate the efficacy and safety of FF/VI compared with two usual ICS/LABA fixed combination (fluticasone propionate/salmeterol \[FP/S\] or budesonide/formoterol \[BUD/F\]) in subjects with persistent asthma, in a "close to real life" settings. FF/VI will be administered once-daily (QD) via ELLIPTA dry powder inhaler (DPI) and FP/S or BUD/F will be administered twice daily (BID) via DISKUS™ and TURBUHALER™ DPI respectively. ELLIPTA is a new powder inhaler designed to be easy to use. The total duration of subject participation will be approximately 6 months (24 weeks). ELLIPTA and DISKUS are registered trademarks of the GSK group of companies. TURBUHALER is a registered trademark of AstraZeneca.


Options:
A: Change From Baseline in Asthma Control Test (ACT) Total Score at Week 12 (Baseline and Week 12)
B: Pre-dose FEV1 (Forced Expiratory Volume in the first second) (at Week 26); Reduction of moderate and severe asthma exacerbations rate (Week 0 to Week 52)
C: Change From Baseline in Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) at Week 12 (Baseline and Week 12)
D: The primary efficacy endpoint is the change in pre dose Forced Expiratory Volume in one second (FEV1) from baseline to 2-hours post dose FEV1 at Week 12. (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Study Comparing Single-Agent Olaparib or the Combination of Cediranib and Olaparib to Standard Platinum-Based Chemotherapy in Women With Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Brief Summary: This phase III trial studies olaparib or cediranib maleate and olaparib to see how well they work compared with standard platinum-based chemotherapy in treating patients with platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer that has come back. Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cediranib maleate may stop the growth of ovarian, fallopian tube, or primary peritoneal cancer by blocking the growth of new blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as carboplatin, paclitaxel, gemcitabine hydrochloride, and pegylated liposomal doxorubicin hydrochloride work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether olaparib or cediranib maleate and olaparib is more effective than standard platinum-based chemotherapy in treating patients with platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer.


Options:
A: Overall survival (Approximately 36 months after last patient randomized and observation of 244 events)
B: 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.)
C: Progression Free Survival Determined Using Response Evaluation Criteria in Solid Tumors Version 1.1 Criteria (The protocol required lesion assessments every 9 weeks from cycle 1, day 1 for the first year, then every 12 weeks thereafter until disease progression. An average of approximately 10 months.)
D: Progression Free Survival (PFS) (Radiologic scans performed at weeks 9 and 18 (+/-1 week) and every 12 weeks thereafter relative to the date of randomisation until the primary analysis (approximately 20 months))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Study Comparing Single-Agent Olaparib or the Combination of Cediranib and Olaparib to Standard Platinum-Based Chemotherapy in Women With Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Brief Summary: This phase III trial studies olaparib or cediranib maleate and olaparib to see how well they work compared with standard platinum-based chemotherapy in treating patients with platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer that has come back. Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cediranib maleate may stop the growth of ovarian, fallopian tube, or primary peritoneal cancer by blocking the growth of new blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as carboplatin, paclitaxel, gemcitabine hydrochloride, and pegylated liposomal doxorubicin hydrochloride work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether olaparib or cediranib maleate and olaparib is more effective than standard platinum-based chemotherapy in treating patients with platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer.


Options:
A: Progression free survival (30 months)
B: objective response rate (24month)
C: Stage 1: Dose Limiting Toxicities (Up to 12 months); Stage 2: Progression Free Survival (Up to 24 months)
D: Progression Free Survival Determined Using Response Evaluation Criteria in Solid Tumors Version 1.1 Criteria (The protocol required lesion assessments every 9 weeks from cycle 1, day 1 for the first year, then every 12 weeks thereafter until disease progression. An average of approximately 10 months.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Study Comparing Single-Agent Olaparib or the Combination of Cediranib and Olaparib to Standard Platinum-Based Chemotherapy in Women With Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Brief Summary: This phase III trial studies olaparib or cediranib maleate and olaparib to see how well they work compared with standard platinum-based chemotherapy in treating patients with platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer that has come back. Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cediranib maleate may stop the growth of ovarian, fallopian tube, or primary peritoneal cancer by blocking the growth of new blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as carboplatin, paclitaxel, gemcitabine hydrochloride, and pegylated liposomal doxorubicin hydrochloride work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether olaparib or cediranib maleate and olaparib is more effective than standard platinum-based chemotherapy in treating patients with platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer.


Options:
A: Progression Free Survival Determined Using Response Evaluation Criteria in Solid Tumors Version 1.1 Criteria (The protocol required lesion assessments every 9 weeks from cycle 1, day 1 for the first year, then every 12 weeks thereafter until disease progression. An average of approximately 10 months.)
B: To show superiority of patupilone in overall survival compared to doxorubicin in taxane/platinum resistant patients with ovarian cancer (every 8 weeks)
C: Progression-free Survival (PFS) (From randomization until evidence of progressive disease or death, whichever occurred first (average of 15.2 months))
D: Progression-free survival (Apr 2013)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Study Comparing Single-Agent Olaparib or the Combination of Cediranib and Olaparib to Standard Platinum-Based Chemotherapy in Women With Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Brief Summary: This phase III trial studies olaparib or cediranib maleate and olaparib to see how well they work compared with standard platinum-based chemotherapy in treating patients with platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer that has come back. Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cediranib maleate may stop the growth of ovarian, fallopian tube, or primary peritoneal cancer by blocking the growth of new blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as carboplatin, paclitaxel, gemcitabine hydrochloride, and pegylated liposomal doxorubicin hydrochloride work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether olaparib or cediranib maleate and olaparib is more effective than standard platinum-based chemotherapy in treating patients with platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer.


Options:
A: Progression Free Survival Determined Using Response Evaluation Criteria in Solid Tumors Version 1.1 Criteria (The protocol required lesion assessments every 9 weeks from cycle 1, day 1 for the first year, then every 12 weeks thereafter until disease progression. An average of approximately 10 months.)
B: ORR (Up to 2 years); PFS (Up to 2 years)
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 (PFS) Differences Between Ixabepilone Alone and Ixabepilone + Bevacizumab (Up to 37 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Cracking the Egg Potential: Improving Young Child Nutrition in Ecuador
Brief Summary: The proposed study will fill an important gap in the literature by examining, through a randomized controlled trial, the effect of egg consumption on biochemical markers of choline, vitamin B-12, lipids, and amino acids in young children in a poor rural area of Ecuador. Children from Cotopaxi Province, Ecuador (n=180) will be randomized into one of two groups: 1) intervention, receiving one egg per day for six months; or 2) control. Baseline and endline data on socio-economic factors, and child diet, morbidities, and anthropometry will be collected. Blood will also be drawn from the children at these time points for nutrient biomarker analyses. Through qualitative research the proposed study will provide insight into the attitudes, beliefs, and use of eggs by mothers and other caregivers during the complementary feeding period. The University of San Francisco in Quito (USFQ) will be the lead field coordinator of the research working in partnership with Washington University in St. Louis, Pan-American Health Organization (PAHO) and University of California, Davis.


Options:
A: Serum/plasma concentrations of B12, choline, and betaine (6 months); Serum/plasma concentrations of polyunsaturated fatty acids (PUFAs) and amino acids (6 months)
B: Change of linear growth (6 months)
C: Linear growth velocity (6 to 18 months of age)
D: Linear Growth (6-18 mos of age)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Self-Administered Lidocaine Gel for Pain Management With First Trimester Surgical Abortion: A Randomized Controlled Trial
Brief Summary: Despite global efforts to decrease discomfort during surgical abortion, pain remains a limiting factor in where and how procedures are performed. Several studies have investigated different methods of delivering cervical anesthesia prior to abortion, however to the best of the investigators' knowledge, there is no published data that 1) rigorously examines the effect of a time interval between local anesthetic administration and procedure initiation, or 2) explores whether adequate pain relief is possible through self-administered, non-invasive means alone. Research in this area has a significant public health impact, given the large number of women worldwide who seek abortions.

The investigators propose to explore the effect of a locally applied vaginal lidocaine gel in place of the traditional paracervical block prior to first trimester surgical abortion. They hypothesize that lidocaine gel is no worse than paracervical block at decreasing abortion related pain at a variety of time points throughout the procedure. This is a non-inferiority, open label, randomized controlled trial.

If self-administered vaginal gel is acceptable and effective, it would increase options for pain control during abortion and other gynecologic procedures.


Options:
A: Difference in Pain Level at Time of Cervical Dilation as Measured by a Visual Analog Scale (At time of cervical dilation, 30 minutes after lidocaine administration)
B: Pain scale
C: Pain reported with cervical dilation (1 Year)
D: Patient Perception of Pain (At time of uterine aspiration (baseline))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Clinical Trial to Investigate the Management for the Integral Assessment Model of Chronic Disease Supported in Information Technology and Communication.
Brief Summary: Controlled and Randomized Clinical trial with 3 parallel groups (intervention group with a health platform NOMHADchronic, phone-based care group, usual care group) developed in the Valencia La Fe Health Department. 495 high-complexity chronic patients will be included according to a combined recruitment based on a risk predictive model plus clinical opinion. Patients will be followed-up during 12 months in order to evaluate health-related quality of life, mortality, health consumption, health direct cost and treatment satisfaction.


Options:
A: Evaluation of effects (T1: Initial evaluation; T2: after three months; T3: one year after T1)
B: Health Related Quality of Life according to EuroQoL (5 questions, 3 levels) (12 months)
C: Composite: Proportion of patients with any risk factor as defined in secondary outcome measures to 9, who have received any high risk prescriptions of anti-inflammatory drugs or antiplatelets as defined in secondary outcome measures 1 to 9 (8 weeks)
D: The assumed role in the decision making process, and the preferred and chosen options. (3 to 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Long Term Cocoa Flavanol Intake on Blood Pressure and Platelet Function in Healthy Adults, Part 1
Brief Summary: Flavanols are plant-derived compounds commonly present in the human diet. Examples of flavanol-containing foods and beverages are apples, chocolate, tea, wine, berries, pomegranate and nuts. The consumption of flavanol-containing foods and beverages has been associated with improvements in cardiovascular health. In this study, the investigators hope to learn more about the effects of the consumption of increasing amounts of cocoa flavanols on blood pressure, platelet function and other metabolic parameters in healthy humans. This study was followed by a second study that aimed at investigating the effects of long term consumptions of cocoa flavanols on blood pressure, platelet function and other metabolic parameters in healthy humans.


Options:
A: Changes in systolic and diastolic blood pressure (8 weeks)
B: Changes in endothelial function and blood pressure (within the first 12 weeks of chocolate intake (week 12 and baseline))
C: percentage reduction of women with metabolic syndrome (at baseline and after 6 months.)
D: Change in blood pressure (Baseline (day 0) and 14, 28, 42 and 56 days after intervention); Change in platelet function (Baseline and 14, 28, 42 and 56 days after intervention); Change in metabolic parameters in blood (Baseline (day 0) and 14, 28, 42 and 56 days after intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Cocoa Flavanol Intake on Blood Pressure and Platelet Function in Healthy Adults, Part 2
Brief Summary: Flavanols are plant-derived compounds commonly present in the human diet. Examples of flavanol-containing foods and beverages are apples, chocolate, tea, wine, berries, pomegranate and nuts. The consumption of flavanol-containing foods and beverages has been associated with improvements in cardiovascular health. In this study, the investigators hope to learn more about the effects of long term consumptions of cocoa flavanols on blood pressure, platelet function and other metabolic parameters in healthy humans. This study is a continuation of a previous study investigating the consumptions of increasing amounts of cocoa flavanols on blood pressure, platelet function and other metabolic parameters in healthy humans


Options:
A: Vascular function (Measured at weeks 4 and 12)
B: Change from baseline of Plasma Oxidized LDL (Baseline and 4 weeks)
C: Change in blood pressure (Baseline (day 0) and 6,12 and 14 weeks after intervention)
D: Blood lipids (after 4 weeks intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Characterizing Variability in Hearing Aid Outcomes Among Older Adults
Brief Summary: The goal of this project is to find out if the way a hearing aid processes a sound signal should be determined in part by an individual's cognitive characteristics. We anticipate that the outcome of this work will be a battery of assessments that will guide hearing aid processing for older patients with hearing loss.


Options:
A: To investigate whether the use of QOL questionnaires during the assessment and management of lung cancer patients results in improved quality of life
B: Change in Patient Quality of Life at Baseline and 8 Months (Baseline and 8 months)
C: Change from Baseline to 12 months after inclusion of Perceived efficacy by the patient of patient-physician interactions (PEPPI) (Baseline and Month 12)
D: Speech Intelligibility Score (6 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Healthy Nutrition and Energy Restriction as Cancer Prevention Strategies: a Randomized Controlled Intervention Trial
Brief Summary: This study evaluates the effect of intermittent calorie restriction versus continued calorie restriction on weight loss, gene expression profile of subcutaneous adipose tissue and abdominal fat distribution.


Options:
A: Revised QUICKI (RQUICKI) (Baseline); RQUICKI (day 29); RQUICKI (day 31)
B: Fat loss and lean mass retention (14 weeks); Weight loss (14 weeks); Absolute changes in body composition (14 weeks)
C: Changes in body weight (Kilograms) (Baseline and 16 weeks); Change in insulin resistance (Baseline and 16 weeks)
D: Changes in gene expression in subcutaneous adipose tissue measured by whole genome sequencing (Assessments at baseline (week 0), and after the intervention phase (week 13))

Answer: D