TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Postoperative Antibiotic Requirements Following Immediate Breast Reconstruction
Brief Summary: Antibiotics are used routinely in postoperative tissue expander based breast reconstruction (TE) and autologous flap (AF) breast reconstruction procedures. Closed suction drains are also used routinely in immediate breast reconstruction to prevent fluid accumulation and seroma formation at the surgical sites. Antibiotics are most often prescribed as a precaution since drains can be a source for infection by creating open channels to outside contaminants. Plastic surgery patients without closed suction drainage devices are usually not placed on prolonged postoperative antibiotics. Current preoperative surgical antibiotic prophylaxis is recommended for up to 24 hours only. These recommendations do not take into account the increased risk of indwelling closed suction drains. A recent survey of plastic surgeons, conducted by SBUMC investigators, (IRB# 129415) found that Plastic Surgeons are divided as to extended outpatient administration following TE breast reconstruction.

The study plans to prospectively enroll patients who will undergo immediate breast reconstruction with TE or AF based breast reconstruction. Using the above data and the current protocol, the investigators will investigate the optimal antibiotic discontinuation period for these patients. The investigators hypothesize that the use of 24-hour perioperative antibiotics in TE or AF based immediate breast reconstruction with closed suction drainage, does not result in an increased infection rate compared to prolonged postoperative antibiotic administration.


Options:
A: Surgical Site Infection (as defined by the Centers for Disease Control and Prevention) (Wounds were assessed on the first post-operative day, then patients were followed-up every week after discharge for the duration of 30 days)
B: Number of Patients With Body Mass Index (BMI) Over 25 Who Developed Surgical Site Infection (SSI) in Groups Who Received Antibiotic Prophylaxis (Prophylaxis Group) and no Prophylaxis (No Prophylaxis Group). (1 month)
C: Surgical Site infection (365 days after the procedure)
D: Drainage volume (7 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Randomized, Open-Label, Dose Titration, Efficacy and Safety Study of FG-4592 (Roxadustat) in Non-Dialysis Chronic Kidney Disease Patients With Anemia
Brief Summary: The primary purpose of this study is to evaluate efficacy and safety of roxadustat in the correction of anemia in participants with non-dialysis chronic kidney disease.


Options:
A: Change From Baseline (BL) to the Average Hemoglobin (Hb) in Weeks 28-36 Without Rescue Therapy [EU (EMA)] (Baseline and weeks 28 to 36); Change From BL to the Average Hb in Weeks 28 to 52 Regardless of Rescue Therapy [US (FDA)] (Baseline and weeks 28 to 52)
B: Number of participants with adverse events (Approximately 9 weeks); Blood pressure (Approximately 9 weeks); Heart rate (Approximately 9 weeks); Cmax (Pre-dose and up to 48 h post-dose); Cmax/D (Pre-dose and up to 48 h post-dose); AUC (Pre-dose and up to 48 h post-dose); AUC/D (Pre-dose and up to 48 h post-dose); Heart rate over 1 min (Pre-dose and up to 24 h post-dose); Standing blood pressure procedure (Starting from 2 h post-dose and up to 4 h post-dose); Impedance cardiography (Pre-dose and up tp 8 h post-dose)
C: Number (%) of Participants With an Hb Response by Week 17 (Up to Week 17)
D: Mean Hb (Hemoglobin) level (From week 30 to 36); Change in hemoglobin level from baseline to the average during the evaluation period (Baseline and week 30 to 36)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Life Goals Behavioral Change to Improve Outcomes for Veterans With SMI
Brief Summary: Persons with serious mental illness are at increased risk of cardiovascular disease. The goals of this study are to test a treatment, Life Goals Collaborative Care to help promote health behavior change and to get feedback from patients and providers on what is needed to help better coordinate and physical and mental health care of these patients.


Options:
A: global Framingham Risk Score (18 months)
B: Number of relapses during intervention (During the entire 6 months study period)
C: overall health-related quality of life (6 months)
D: Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time (Baseline, Month 6, month 12, month 18 and month 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Long-term Study to Evaluate the Safety and Tolerability of Fluticasone Furoate (FF)/GW642444 Inhalation Powder and FF Inhalation Powder in Japanese Subjects With Asthma
Brief Summary: The primary purpose of the study is to assess the safety and tolerability of 52-week teatment with fluticasone furoate/GW642444 inhalation powder once-daily and FF inhalation powder once-daily in Japanese adult subjects with asthma.


Options:
A: Change From Baseline in Evening (Post Meridiem [PM]) Forced Expiratory Volume in One Second (FEV1) Using Intent-to-Treat (ITT) Population (Baseline and Week 24); Change From Baseline in PM FEV1 Using Per Protocol (PP) Population (Baseline and Week 24)
B: Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) (From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD]))
C: Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24 (24 Weeks); Rate of severe asthma exacerbations (Up to 52 Weeks)
D: Change From Baseline in Weighted Mean Forced Expiratory Volume in One Second (FEV1) Over 0 to 24 Hours Post-dose at the End of the 12-week Treatment Period (Baseline and Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of a Water Beverage Intervention Trial for Reducing Risk Factors of Metabolic Syndrome in Young Mexican Free Living Women
Brief Summary: Research Question: Does replacing Sugar Sweetened (SS) beverages with water consumption promote a decrease in triglycerides blood levels over 9 months in overweight women? The primary outcome variable is the triglycerides blood level. In addition, the investigators will consider as secondary outcome variables the following parameters of metabolic syndrome: weight, fasting insulin and glucose, HOMA, HDL-cholesterol, systolic and diastolic blood pressure, and waist circumference. The investigators will also consider as an outcome variable glycosylated (or glycated) hemoglobin (HbA1c).

Design: Two groups randomized controlled trial, with an intervention group (water and education provision) and control group (education provision only).

The investigators propose to recruit young adult women aged \>18-\<45 y who are overweight or obese (BMI \>25 and \<39), and consume at least 250 calories per day from caloric beverages (e.g., includes soft drinks, juices, sports drinks, sweetened tea or coffee, and alcoholic beverages) The intervention group (water and education provision) will be compared with a control condition (education provision only). The intervention has been proposed to be carried out for 9 months period with objective measurements of body weight and fat, total cholesterol, LDL-C, HDL-C, fasting blood glucose, HbA1C, hydration status, blood pressure, and 24 hrs dietary recalls at baseline, 3,6 and 9 months


Options:
A: Triglycerides blood level (baseline); Triglycerides blood levels (3 months); Triglycerides blood Levels (6 months); Triglycerides blood levels (9 months)
B: Overweight (one school year)
C: Body mass index (BMI) >= 85th percentile, adjusted for gender and age (baseline, end of 7th grade, end of study); Fasting glucose (mg/dL) (baseline, end of study); Fasting insulin (mU/mL) (baseline, end of study)
D: Employee purchases of healthy (green-labeled) items (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized, Open-label Study Comparing GSK1120212 to Chemotherapy in Subjects With Advanced or Metastatic BRAF V600E/K Mutation-positive Melanoma
Brief Summary: This is a two-arm, open-label, randomized Phase III study comparing single agent GSK1120212 to chemotherapy (either dacarbazine or paclitaxel) in subjects with Stage IIIc or Stage IV malignant cutaneous melanoma. All subjects must have a BRAF mutation-positive tumour sample. Subjects who have received up to one prior regimen of chemotherapy in the advanced or metastatic melanoma setting will be enrolled into the study. Subjects with any prior BRAF or MEK inhibitor use will be excluded. Approximately 297 subjects will be enrolled with 2:1 randomization (198 subjects into the GSK1120212 arm and 99 subjects into the chemotherapy arm). The primary endpoint for the statistical analysis will be a comparison of progression free survival for subjects receiving GSK1120212 compared to chemotherapy. Subjects who have progression on chemotherapy will be offered the option to receive GSK1120212.


Options:
A: Progression-free Survival in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases as Assessed by the Investigator and Independent Review (Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months))
B: Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 in Combination With gp 100 Melanoma Peptide Vaccine Versus gp 100 Melanoma Peptide Vaccine Alone (From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks))
C: Progression-free Survival (Baseline to the 21 July 2019 data cut-off (up to 7 years, 6 months))
D: Major Pathologic Response (MPR) (54 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Deep Brain Stimulation of the Nucleus Accumbens as a Novel Treatment in Severe Opioid Addiction
Brief Summary: The main objective of this study is to assess the efficacy of bilateral deep brain stimulation (DBS) of the Nucleus accumbens (NAc) as a novel treatment in severe opioid addiction. The included patients have been treated so far with a substitute in form of methadone.

Our hypothesis is that bilateral DBS of the NAc will significantly reduce the craving for heroin and thus enable the patients to decrease their Levomethadone-dosage substantially.


Options:
A: cognitive improvement (one- year)
B: Reduction of Levomethadone (seven month)
C: Number of Participants With a 40% Reduction in Total Tics on the Yale Global Tic Severity Scale (YGTSS) With CDBS (Period 1) (Baseline to 6 months post-surgery)
D: Safety: Time to Reach a 4 Point Increase (Worsening) in Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score (baseline to 24 months); Levodopa Equivalents, Change From Baseline (baseline to 24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Fixed-dose Combination Therapy (PolyPill) in Prevention of Cardiovascular Disease in Middle-aged and Elderly Iranians - Focus on Liver-Related Variables.
Brief Summary: The primary purpose of this study is to determine the effects of a fixed dose combination of valsartan, hydrochlorothiazide, atorvastatin and aspirin (PolyPill) on prevention of cardiovascular events in adults older than 50.

Various liver-related variables will also be recorded which will allow studying the effects of PolyPill on the liver and the effect of liver diseases such as nonalcoholic steatohepatitis on cardiovascular events and the protective effect of PolyPill.


Options:
A: Liver Histological improvement (48 weeks)
B: Percentage of Responders With Disappearance of Steatohepatitis Without Worsening of Fibrosis (ie, Participants no Longer Meeting the Criteria for Steatohepatitis) (Baseline (Visit 2; Week 0) to Visit 8 (Week 52))
C: Major Cardiovascular Events (5 years)
D: Improved metabolic parameters(glucose, lipid, liver enzymes, etc.) (16 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Fixed-dose Combination Therapy (PolyPill) in Prevention of Cardiovascular Disease in Middle-aged and Elderly Iranians - Focus on Liver-Related Variables.
Brief Summary: The primary purpose of this study is to determine the effects of a fixed dose combination of valsartan, hydrochlorothiazide, atorvastatin and aspirin (PolyPill) on prevention of cardiovascular events in adults older than 50.

Various liver-related variables will also be recorded which will allow studying the effects of PolyPill on the liver and the effect of liver diseases such as nonalcoholic steatohepatitis on cardiovascular events and the protective effect of PolyPill.


Options:
A: Proportion of patients receiving AAS, an ACE inhibitor and a statin among those without contraindications to any of these drugs Adherence to treatment measured by: Morinsky-Green test and Pill accountability. (18 months); Adherence to treatment measured by the Morisky-Green questionnaire (18 months); Treatment adherence measured by: Morisky-Green test: (Good adherence score 16-20) at 1 and 9 months. (18 months); Treatment adherence measured by: Pill counts at 1-4-9 months. (Good adherence 80-110% PC) (18 months)
B: Major Cardiovascular Events (5 years)
C: Profile of Pharmacokinetics (0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72 hours post-dose)
D: Number of patients who reach target blood pressure (From baseline to the end of the 3-month study period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Early vs. Later Palliative Cancer Care: Clinical and Biobehavioral Outcomes
Brief Summary: ENABLE III is a randomized clinical trial that evaluates a phone-based palliative care intervention designed to improve quality of life, mood, and symptom management for patients with an advanced stage cancer and their caregivers.

The primary aims of this clinical trial are to determine whether a palliative care intervention (introduced immediately or 12 weeks after diagnosis) can improve survival, quality of life, mood, symptom intensity and end-of-life care.


Options:
A: Patient Heath Related Quality of Life (HRQL) as measured by the FACT-G, QUAL-E and FACIT-Sp. (Three months after enrollment.)
B: Reduction in the EORTC QLQ-C30 scale that constitutes the patient's primary need (Baseline, 3 weeks and 8 weeks)
C: N/A
D: Change in patient's quality of living over time (baseline, 6,12,18,24,36 and every 12 weeks until death or end of study); Quality of end of life care (chart review at time of death and caregiver proxy interview 2-3 months after patient death); Estimate and compare the hazard ratios and median survival before and after 1 year from enrollment (From enrollment until patient death or end of study); Change in caregiver quality of life, burden and grief over time (baseline, 6,12,18,24,36, and every 12 weeks until patient death or end of study)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Early vs. Later Palliative Cancer Care: Clinical and Biobehavioral Outcomes
Brief Summary: ENABLE III is a randomized clinical trial that evaluates a phone-based palliative care intervention designed to improve quality of life, mood, and symptom management for patients with an advanced stage cancer and their caregivers.

The primary aims of this clinical trial are to determine whether a palliative care intervention (introduced immediately or 12 weeks after diagnosis) can improve survival, quality of life, mood, symptom intensity and end-of-life care.


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

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Combined Lifestyle and Medication Intervention to Reduce CVD Risk
Brief Summary: Cardiovascular disease (CVD), including heart disease and stroke, is the leading cause of death in the US. Every year, more than one million Americans have a heart attack, and nearly 800,000 have a stroke. In 2010, heart disease alone is expected to cost the country more than $316 billion in health care and lost productivity.

Both lifestyle changes and medication can reduce the risk of CVD, and this project combines these approaches in the hopes of identifying a practical intervention for use in primary care medical offices. The project combines two previously tested interventions and updates them to meet current guidelines for diet and use of aspirin and cholesterol-controlling drugs (statins).

The research team is delivering the combined intervention in two formats: web-based and counselor-based. Each format has the same content, but the web-based advice is accessed through the Internet by clients at home, a community site, or a primary care office. The other format involves sessions delivered to clients by a counselor either in person at a primary care office or over the telephone. The researchers will compare how effective each format is in reducing participants' risk of coronary heart disease. They will also determine the interventions' effect on participants' diet, physical activity, smoking status, medication adherence, and other health indicators. In addition, the team will compare the two formats' cost-effectiveness and how well the patients, office staff, and clinicians accept the interventions.

Recruited from five family practices, 600 patients representing the geographic and ethnic diversity of North Carolina are taking part in this study. Half the participants are randomly assigned to the web-based intervention; the other half to the counselor-based version. Both groups will also get information on local resources, such as gyms and farmers markets, that can help participants maintain a healthy lifestyle.


Options:
A: Predicted 10-year CHD risk (4-month follow-up)
B: Change in proportion of pills taken compared to baseline (0-2months) at 8months; Between-group comparison of medication persistence at 14months
C: Changes in decisional conflict (baseline and 3 month post intervention)
D: Geriatric Depression Scale (12 months); Physical Performance Test (PPT) (12 months); SF-36 Health Survey (12 months); Mental Mental Status Exam (MMSE) (12 months); Hospitalization (12 month enrollment period); Hospital Days (12 Month Enrollment Period); Emergency Department Visits (12 month Enrollment Period); Medicare Costs (12 Month Enrollment Period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Combined Lifestyle and Medication Intervention to Reduce CVD Risk
Brief Summary: Cardiovascular disease (CVD), including heart disease and stroke, is the leading cause of death in the US. Every year, more than one million Americans have a heart attack, and nearly 800,000 have a stroke. In 2010, heart disease alone is expected to cost the country more than $316 billion in health care and lost productivity.

Both lifestyle changes and medication can reduce the risk of CVD, and this project combines these approaches in the hopes of identifying a practical intervention for use in primary care medical offices. The project combines two previously tested interventions and updates them to meet current guidelines for diet and use of aspirin and cholesterol-controlling drugs (statins).

The research team is delivering the combined intervention in two formats: web-based and counselor-based. Each format has the same content, but the web-based advice is accessed through the Internet by clients at home, a community site, or a primary care office. The other format involves sessions delivered to clients by a counselor either in person at a primary care office or over the telephone. The researchers will compare how effective each format is in reducing participants' risk of coronary heart disease. They will also determine the interventions' effect on participants' diet, physical activity, smoking status, medication adherence, and other health indicators. In addition, the team will compare the two formats' cost-effectiveness and how well the patients, office staff, and clinicians accept the interventions.

Recruited from five family practices, 600 patients representing the geographic and ethnic diversity of North Carolina are taking part in this study. Half the participants are randomly assigned to the web-based intervention; the other half to the counselor-based version. Both groups will also get information on local resources, such as gyms and farmers markets, that can help participants maintain a healthy lifestyle.


Options:
A: Adherence to the decision to use or not to use statins
B: The proportion of high-risk individuals that have been assessed for cardiovascular risk (12 months after intevention); The proportion of individuals with correct knowledge about the effects of behavioural determinants of the risk of cardiovascular disease (12 months from intervention)
C: Low-density Lipoprotein Cholesterol (Measured at 1 year); Systolic Blood Pressure (Measured at 1 year); HbA1c (Measured at 1 year)
D: Predicted 10-year CHD risk (4-month follow-up)

Answer: D