TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Treatment for Active Alcoholic Smokers
Brief Summary: Alcohol dependence is a significant and prevalent public health problem affecting approximately 4% of the U.S. adult population. Individuals with alcohol dependence actively seek treatment annually, and long-term alcohol abstinence varies from 40-60%. Because of the high smoking prevalence and trends toward heavier smoking, alcoholic smokers are at high risk for both morbidity and mortality related to alcohol consumption and tobacco dependence. Although several studies have evaluated pharmacotherapy for tobacco dependence in recovering alcoholic smokers, few have evaluated pharmacotherapy for tobacco dependence among currently drinking alcoholic smokers.

Varenicline is the most effective medication currently available for treating tobacco dependence. While some randomized trials have included recovering alcoholics, active alcoholism has been an exclusion criteria for these trials. Thus, this proposal would be the first such clinical trial in currently drinking alcoholic smokers. In addition to helping smokers to stop smoking, varenicline has also been shown to reduce alcohol consumption in rats. The goal of this proposal is to explore the potential efficacy of varenicline for treating tobacco dependence and reducing drinking among alcohol dependent smokers.

The investigators hypothesize that 12 weeks of treatment with varenicline, a partial nicotinic acetylcholine receptor agonist will be more effective than placebo in treating tobacco dependence and reducing nicotine withdrawal symptoms in currently drinking alcoholic smokers. The investigators will also explore whether varenicline has an effect on drinking behavior among currently drinking alcoholics. The investigators propose the following specific aims to test these hypotheses in 70 currently drinking alcoholic smokers recruited at the Mayo Clinic in Rochester, Minnesota.


Options:
A: Prevention in relapse (Up to 6 months)
B: Tobacco-cessation rates (30-day point prevalence) at one year.
C: Smoking Behavior (Nine weeks)
D: Prolonged Smoking Abstinence at End of 12 Weeks of Varenicline Treatment (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Treatment for Active Alcoholic Smokers
Brief Summary: Alcohol dependence is a significant and prevalent public health problem affecting approximately 4% of the U.S. adult population. Individuals with alcohol dependence actively seek treatment annually, and long-term alcohol abstinence varies from 40-60%. Because of the high smoking prevalence and trends toward heavier smoking, alcoholic smokers are at high risk for both morbidity and mortality related to alcohol consumption and tobacco dependence. Although several studies have evaluated pharmacotherapy for tobacco dependence in recovering alcoholic smokers, few have evaluated pharmacotherapy for tobacco dependence among currently drinking alcoholic smokers.

Varenicline is the most effective medication currently available for treating tobacco dependence. While some randomized trials have included recovering alcoholics, active alcoholism has been an exclusion criteria for these trials. Thus, this proposal would be the first such clinical trial in currently drinking alcoholic smokers. In addition to helping smokers to stop smoking, varenicline has also been shown to reduce alcohol consumption in rats. The goal of this proposal is to explore the potential efficacy of varenicline for treating tobacco dependence and reducing drinking among alcohol dependent smokers.

The investigators hypothesize that 12 weeks of treatment with varenicline, a partial nicotinic acetylcholine receptor agonist will be more effective than placebo in treating tobacco dependence and reducing nicotine withdrawal symptoms in currently drinking alcoholic smokers. The investigators will also explore whether varenicline has an effect on drinking behavior among currently drinking alcoholics. The investigators propose the following specific aims to test these hypotheses in 70 currently drinking alcoholic smokers recruited at the Mayo Clinic in Rochester, Minnesota.


Options:
A: Continuous Abstinence Rate (CAR) From Week 9 Through Week 12 (Week 9 through Week 12)
B: Prolonged Smoking Abstinence at End of 12 Weeks of Varenicline Treatment (12 weeks)
C: Biochemically confirmed continuous 30-day abstinence from smoking (12 weeks post-Target Quit Day (TQD))
D: Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. (Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Controlled Trial Using a TELEmedicine Solution to Improve MEDication Adherence in Chronic Heart Failure (TELEMED-HF)
Brief Summary: TELEMED-HF is a randomized, controlled clinical intervention trial designed to: (1) examine the efficacy of an electronic Medication Adherence Support System (MASS) in improving and monitoring patients' medication adherence; to (2) i determine the effect of medication adherence on hospitalization and health care consumption.


Options:
A: BP control at primary care visit; Systolic and diastolic BPs as recorded at each primary care provider visit during 24 month enrollment period.
B: Treatment Completion (13 weeks); PTSD Checklist-Military (PCL-M) (26 weeks); Beck Depression Inventory-II (BDI-II) (26 weeks)
C: Change in medication adherence (Baseline, 6 months, 9 months, 12 months, 15 months, and 18 months); Change in number of hospitalizations (costs) (Baseline, 6 months, 9 months, 12 months, 15 months, and 18 months)
D: Rate of all-cause hospital readmission or death during the 6-month follow-up period. (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Danish Palliative Care Trial (DanPaCT): A Randomised Clinical Multi-centre Trial Investigating the Effect of Specialised Palliative Care on Symptoms, Survival, Economical Factors and Satisfaction in Patients With Cancer Reporting Palliative Needs
Brief Summary: Specialised palliative care (SPC) seeks to relieve suffering and improve quality of life in patients with a life threatening disease such as advanced cancer. Many patients with advanced cancer are not in contact with SPC. Previous studies have shown that among advanced cancer patients not referred to SPC there is a significant prevalence of symptoms, problems and needs. The aims of the present study are to investigate whether patients with metastatic cancer, who report palliative needs in a screening, will benefit from being referred to SPC and to investigate the economical consequences of such a referral.


Options:
A: N/A
B: Patient Heath Related Quality of Life (HRQL) as measured by the FACT-G, QUAL-E and FACIT-Sp. (Three months after enrollment.)
C: Assess the impact of early integration with palliative care on QOL in patients with advanced NSCLC. (3 years)
D: Reduction in the EORTC QLQ-C30 scale that constitutes the patient's primary need (Baseline, 3 weeks and 8 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Danish Palliative Care Trial (DanPaCT): A Randomised Clinical Multi-centre Trial Investigating the Effect of Specialised Palliative Care on Symptoms, Survival, Economical Factors and Satisfaction in Patients With Cancer Reporting Palliative Needs
Brief Summary: Specialised palliative care (SPC) seeks to relieve suffering and improve quality of life in patients with a life threatening disease such as advanced cancer. Many patients with advanced cancer are not in contact with SPC. Previous studies have shown that among advanced cancer patients not referred to SPC there is a significant prevalence of symptoms, problems and needs. The aims of the present study are to investigate whether patients with metastatic cancer, who report palliative needs in a screening, will benefit from being referred to SPC and to investigate the economical consequences of such a referral.


Options:
A: length of stay hospital, intensive care unit and emergency admissions (1 year)
B: 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)
C: Quality of life and quality of mental health at 6 weeks and 12 weeks as compared from baseline (at baseline, 6 weeks and 12 weeks)
D: Reduction in the EORTC QLQ-C30 scale that constitutes the patient's primary need (Baseline, 3 weeks and 8 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label Assessment of Safety and Efficacy of Ruxolitinib (INCB018424) in Subjects With Primary Myelofibrosis, Post- Essential Thrombocythemia Myelofibrosis, and Post-Polycythemia Vera Myelofibrosis Who Have Platelet Counts of 50 × 10^9/L to 100 × 10^9/L
Brief Summary: To evaluate the effects of treatment with ruxolitinib (INCB018424) on spleen volume, symptoms and potential side effects in participants with PMF, PPV-MF and PET-MF who have platelet counts of 50 x 10\^9/L to 100 x 10\^9/L. It is anticipated that individualized dose optimization from the starting ruxolitinib level of 5 mg bid will be associated with reductions in splenomegaly, MF-associated symptoms and inflammatory cytokine levels.


Options:
A: Overall Response Rate (Assessed at the end of cycle 3)
B: Percent Change From Baseline in Spleen Volume at Week 24 by Final Titrated Dose (Baseline and Week 24); Percent Change From Baseline in Total Symptom Score (TSS) as Measured by the Modified Myelofibrosis Symptom Assessment Form (MFSAF) V2.0 Diary at Week 24 by Final Titrated Dose (Baseline and Week 24); Percentage of Participants With Treatment-emergent Adverse Events (TEAE) (Up to Week 156); Percentage of Participants With New Onset Grade 4 Thrombocytopenia Events as Assessed by Common Terminology Criteria for Adverse Events Version 4.03 (CTCAE V4.03) (Up to Week 156); Percentage of Participants With New Onset Grade 2 or Higher Hemorrhage as Assessed by CTCAE V4.03 (Up to Week 156)
C: Number of Participants With Adverse Events (AEs) (From Baseline to the interim clinical cut-off date (31 December 2009). The median time on study was 14.8 months, with a range of 26 days to 29.7 months. As of March 1, 2011 the total exposure to ruxolitinib was 269 patient-years.); Percentage of Participants With Clinical Improvement (CI) Over Time (Week 12, 24, 36, 48 and 60)
D: Number of Patients With Objective Response (Complete and Partial Response + Hematological Improvement) (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This is a single-institution, prospective, randomized controlled trial. Subjects determined to need a cholecystectomy will be consented for surgery and study participation prior to enrollment in this study. Patients will then be randomized to receive either a single port laparoscopic cholecystectomy or a four port laparoscopic cholecystectomy.


Options:
A: Post-operative pain scores (visual analogue pain scale from 0-10)assessed on post-operative day 1 and at the post-operative follow up visit in clinic. The mean pain scores will be compared using student's t-test. (3-6 weeks)
B: Post-operative pain scores (visual analogue pain scale from 0-10) (Before surgery (baseline) and 2 hrs, 4 hrs, 6hrs, 12hrs, 24hrs and 48hrs after surgery)
C: overall morbidity rate (at 60 days from surgery) (60 days)
D: Postoperative pain (24h)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This is a single-institution, prospective, randomized controlled trial. Subjects determined to need a cholecystectomy will be consented for surgery and study participation prior to enrollment in this study. Patients will then be randomized to receive either a single port laparoscopic cholecystectomy or a four port laparoscopic cholecystectomy.


Options:
A: Post-operative pain scores (visual analogue pain scale from 0-10) (Before surgery (baseline) and 2 hrs, 4 hrs, 6hrs, 12hrs, 24hrs and 48hrs after surgery)
B: Post-operative pain 4 hours (4 hours post-operative); Post-operative pain 24 hours (24 hours post-operative); Post-operative pain 14 days (14 days post-operative); Post-operative pain 6 months (6 months post-operative)
C: number of patients with improvement in semen parameters and resolution of testicular pain (2 years)
D: minor complications (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study was to see whether a brief intervention given in adolescence has an effect on smoking in adulthood. The investigators also wanted to clarify the significance of some known psychosocial risk factors of smoking in adulthood.


Options:
A: Patient report (Within 3 days of the dental encounter)
B: being a smoker (29 years)
C: To assess the primary outcome of provider adherence to tobacco use treatment guidelines, we will conduct patient exit interviews with 80 smokers pre and post-intervention at each of the 18 study sites (2880 smokers pre and post). (prior to and approximately 12 months following each site's enrollment in the study); Compare the effectiveness of the three intervention arms on provider behavior for aiding patient's tobacco cessation (June 2013-June 2017)
D: Our primary outcome measures are patient-reported provider delivered tobacco screening and tobacco cessation advice. (Baseline, 8-months post-intervention, and 24-months post-intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Facebook-based Physical Activity Intervention for Young Adult Cancer Survivors: the FITNET Randomized Pilot Study
Brief Summary: The purpose of this study is to determine the feasibility and efficacy of a behavioral intervention, delivered through an existing social networking website (Facebook), on physical activity (moderate-intensity minutes per week) among young adult cancer survivors compared to a self-help education condition. For this research study, investigators will conduct a 12-week randomized trial. After a baseline survey, weekly messages, a pedometer, goal-setting tool, physical activity log and discussion prompts will be delivered to the intervention group. Comparison group participants will receive links to websites with self-help education materials. After 12 weeks, a follow-up survey will be given to both groups. Changes in physical activity, quality of life and psychosocial factors will be examined. The investigators hypothesize that those receiving the intervention will have improved physical activity behaviors at 12-week follow-up relative to those in the comparison group.


Options:
A: Primary study outcome measures at the participant level will be minutes of moderate-intensity physical activity per week and exercise in MET-hrs/week. (Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.)
B: Overall survival (two years)
C: Possible (neuro)physiological determinants of postcancer fatigue (The measurements will be performed at baseline and comparable measurements will be performed 6 months later (after 6 months cognitive behavior therapy or 6 months waiting list condition))
D: Composite of all-cause mortality and all-cause hospitalization rates (measured at Year 3) (Measured as events occur during the lifespan of the trial.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Early MRSA Therapy in CF - Culture Based vs. Observant Therapy (Treat or Observe) (Star-TOO - STaph Aureus Resistance - Treat or Observe)
Brief Summary: Purpose: There has been a recent, rapid increase in prevalence of Methicillin-resistant Staphylococcus aureus (MRSA) among patients with Cystic Fibrosis (22% across US CF centers in 2009). Some epidemiologic studies suggest possible worse outcomes, a recent analyses showing this with chronic but not intermittent MRSA. Given the chronic difficult to treat lung infections in CF it is unclear how the onset of MRSA should be approached. This randomized, controlled, interventional study seeks to determine if an early eradication protocol is effective for eradication of MRSA and will provide an opportunity to obtain data regarding early clinical impact of new isolation of MRSA.

Participants: Cystic fibrosis patients with new isolation of MRSA from their respiratory culture on a routine clinic visit.

Procedures (methods): Randomized, open-label, multi-center study comparing use of an eradication protocol to an observational group who receives the current standard of care i.e. treatment for MRSA only with pulmonary exacerbations.


Options:
A: Number of Patients MRSA Free by Induced Sputum Respiratory Tract Culture (Day 58 (Visit 5), approximately 1 month after completion of the MRSA treatment protocol)
B: Change in P. Aeruginosa Density (from baseline to end of treatment (28 days))
C: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
D: MRSA Culture Status (Day 28)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Early MRSA Therapy in CF - Culture Based vs. Observant Therapy (Treat or Observe) (Star-TOO - STaph Aureus Resistance - Treat or Observe)
Brief Summary: Purpose: There has been a recent, rapid increase in prevalence of Methicillin-resistant Staphylococcus aureus (MRSA) among patients with Cystic Fibrosis (22% across US CF centers in 2009). Some epidemiologic studies suggest possible worse outcomes, a recent analyses showing this with chronic but not intermittent MRSA. Given the chronic difficult to treat lung infections in CF it is unclear how the onset of MRSA should be approached. This randomized, controlled, interventional study seeks to determine if an early eradication protocol is effective for eradication of MRSA and will provide an opportunity to obtain data regarding early clinical impact of new isolation of MRSA.

Participants: Cystic fibrosis patients with new isolation of MRSA from their respiratory culture on a routine clinic visit.

Procedures (methods): Randomized, open-label, multi-center study comparing use of an eradication protocol to an observational group who receives the current standard of care i.e. treatment for MRSA only with pulmonary exacerbations.


Options:
A: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
B: Change in P. Aeruginosa Density (from baseline to end of treatment (28 days))
C: Number of Patients MRSA Free by Induced Sputum Respiratory Tract Culture (Day 58 (Visit 5), approximately 1 month after completion of the MRSA treatment protocol)
D: MRSA Culture Status (Day 28)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Screening for Hepatocellular Carcinoma With Triphasic Helical CT vs. US With Alpha-fetoprotein in Patients With Advanced Liver Disease
Brief Summary: The purpose of this study is to determine whether ultrasound or CT scanning is more effective at detecting early liver cancer in patients with advanced liver disease.


Options:
A: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Up to 24 weeks)
B: Efficacy of screening measure to detect very early/early stage HCC (Barcelona Clinic Liver Cancer Staging System) (6-12 months)
C: PIVKA-II (Day one)
D: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Intramyocardial Stem Cell Therapy in Patients With Dilated Cardiomyopathy
Brief Summary: BACKGROUND. In patients with non-ischemic dilated cardiomyopathy, intracoronary stem cell transplantation has been shown to improve exercise capacity, reduce ventricular remodelling and improve 1-year survival. Pre-clinical data demonstrate that stem cell effects on the diseased heart can be further enhanced by direct intramyocardial delivery route.

AIMS.

1. To evaluate safety and efficacy of intramyocardial stem cell therapy in patients with non-ischemic dilated cardiomyopathy.
2. To directly compare clinical effects of intracoronary and intramyocardial stem cell delivery.

METHODS. Of 60 patients with dilated cardiomyopathy, 30 will be randomized to intramyocardial transplantation of CD34+ cells (Study Group), and 30 will receive intracoronary stem cell therapy (Control Group). In both groups peripheral blood stem cells will be mobilised by daily subcutaneous injections of filgrastim; CD34+ cells will be collected via apheresis and labelled with technetium. In the Study Group electromechanical mapping will be used to identify viable myocardium and intramyocardial injections in the target areas will be performed with NOGA catheter. In the Control group patients will undergo myocardial perfusion scintigraphy and CD34+ cells will be injected intracoronary in the artery supplying segments of reduced viability. Patients will be followed for 1 year. Primary endpoints will include changes in left ventricular ejection fraction and left ventricular dimensions (measured by echocardiography). Secondary endpoints will include changes in exercise capacity and changes in NT-proBNP values.

HYPOTHESES.

1. At 1 year, intramyocardial stem cell therapy will be associated with improved left ventricular ejection fraction, reduced left ventricular dimensions, improved exercise capacity and reduced levels of NT-proBNP.
2. Beneficial effects of intramyocardial stem cell therapy will be superior to those observed with intracoronary stem cell delivery.


Options:
A: Longitudinal change in left ventricular function (ejection fraction) (1 year)
B: Changes in left ventricular ejection fraction and dimensions (1 year)
C: Safety will be assessed by: post-procedure assessments, physical exam, vital signs, laboratory tests, and adverse events including MACE (Major Adverse Cardiac Event) occurrences. (Outcome measures will generally be assessed at baseline, Month 1, Month 3, Month 6 and Month 12)
D: Efficacy between groups post-index procedure (39 weeks post-index)

Answer: B