TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Varenicline and Placebo for Smoking Cessation in Schizophrenia
Brief Summary: The purpose of this proposed pilot study is to examine the use of varenicline in people with schizophrenia to specifically assess tolerability and efficacy for smoking cessation. Specifically, The primary objective of this pilot study is to determine if taking of varenicline along with an individual smoking cessation supportive program is a safe and effective treatment of nicotine addiction in schizophrenic patients. We hypothesize that the varenicline treated patients will achieve higher rates of smoking cessation than those who receive placebo and individual support.


Options:
A: The primary efficacy outcome is smoking abstinence for any continuous 4-week period (4-week CQR) during the study treatment phase.
B: Continuous abstinence (Russell Standard) (Six months post quit date)
C: Change of ExpiredCO Level From Baseline (Weekly for 12 weeks); Level of Nicotine Dependence by Treatment Assignment (Weekly for 12 weeks)
D: Percent Compliance With Chantix (Months 1, 2, 3)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Varenicline and Placebo for Smoking Cessation in Schizophrenia
Brief Summary: The purpose of this proposed pilot study is to examine the use of varenicline in people with schizophrenia to specifically assess tolerability and efficacy for smoking cessation. Specifically, The primary objective of this pilot study is to determine if taking of varenicline along with an individual smoking cessation supportive program is a safe and effective treatment of nicotine addiction in schizophrenic patients. We hypothesize that the varenicline treated patients will achieve higher rates of smoking cessation than those who receive placebo and individual support.


Options:
A: Change of ExpiredCO Level From Baseline (Weekly for 12 weeks); Level of Nicotine Dependence by Treatment Assignment (Weekly for 12 weeks)
B: Continuous 4-week Abstinence From Smoking Between Weeks 8-11 After the Quit Date (Through the End of Treatment) (weeks 8-11 after quit date)
C: 4 week continuous quit rate ( 4 week CQR ) for weeks 9 -12
D: Quit Rate (4 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Varenicline and Placebo for Smoking Cessation in Schizophrenia
Brief Summary: The purpose of this proposed pilot study is to examine the use of varenicline in people with schizophrenia to specifically assess tolerability and efficacy for smoking cessation. Specifically, The primary objective of this pilot study is to determine if taking of varenicline along with an individual smoking cessation supportive program is a safe and effective treatment of nicotine addiction in schizophrenic patients. We hypothesize that the varenicline treated patients will achieve higher rates of smoking cessation than those who receive placebo and individual support.


Options:
A: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)
B: Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt) (weeks 9 through 12)
C: Change of ExpiredCO Level From Baseline (Weekly for 12 weeks); Level of Nicotine Dependence by Treatment Assignment (Weekly for 12 weeks)
D: Number of Subjects With Four Week Continuous Quit Rate (CQR) (Week 9 through Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Varenicline and Placebo for Smoking Cessation in Schizophrenia
Brief Summary: The purpose of this proposed pilot study is to examine the use of varenicline in people with schizophrenia to specifically assess tolerability and efficacy for smoking cessation. Specifically, The primary objective of this pilot study is to determine if taking of varenicline along with an individual smoking cessation supportive program is a safe and effective treatment of nicotine addiction in schizophrenic patients. We hypothesize that the varenicline treated patients will achieve higher rates of smoking cessation than those who receive placebo and individual support.


Options:
A: Varenicline Adherence as Measured by Pill Count (Weeks 0-1, 1-2, 2-3, 4-6, 7-9, 10-12)
B: Change of ExpiredCO Level From Baseline (Weekly for 12 weeks); Level of Nicotine Dependence by Treatment Assignment (Weekly for 12 weeks)
C: Treatment Satisfaction (End of treatment (seven weeks after baseline))
D: Biochemically-confirmed 7-Day Point-Prevalence Abstinence at 26 Weeks (Assessed 26 weeks after the target quit day.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Varenicline and Placebo for Smoking Cessation in Schizophrenia
Brief Summary: The purpose of this proposed pilot study is to examine the use of varenicline in people with schizophrenia to specifically assess tolerability and efficacy for smoking cessation. Specifically, The primary objective of this pilot study is to determine if taking of varenicline along with an individual smoking cessation supportive program is a safe and effective treatment of nicotine addiction in schizophrenic patients. We hypothesize that the varenicline treated patients will achieve higher rates of smoking cessation than those who receive placebo and individual support.


Options:
A: The primary outcome measure for alcohol use will be the number of drinks/week at the end of the treatment phase, relative to baseline and during-treatment data. (8 weeks)
B: Treatment Satisfaction (End of treatment (seven weeks after baseline))
C: Change of ExpiredCO Level From Baseline (Weekly for 12 weeks); Level of Nicotine Dependence by Treatment Assignment (Weekly for 12 weeks)
D: Change in Smoking Behavior (Change in cigarettes per day from Week 2 to Week 5)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Varenicline and Placebo for Smoking Cessation in Schizophrenia
Brief Summary: The purpose of this proposed pilot study is to examine the use of varenicline in people with schizophrenia to specifically assess tolerability and efficacy for smoking cessation. Specifically, The primary objective of this pilot study is to determine if taking of varenicline along with an individual smoking cessation supportive program is a safe and effective treatment of nicotine addiction in schizophrenic patients. We hypothesize that the varenicline treated patients will achieve higher rates of smoking cessation than those who receive placebo and individual support.


Options:
A: Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt) (weeks 9 through 12)
B: effectiveness (2 years)
C: Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 12 (12 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 24 (24 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 52 (52 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 64 (64 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 104 (104 weeks following treatment initiation)
D: Change of ExpiredCO Level From Baseline (Weekly for 12 weeks); Level of Nicotine Dependence by Treatment Assignment (Weekly for 12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Varenicline and Placebo for Smoking Cessation in Schizophrenia
Brief Summary: The purpose of this proposed pilot study is to examine the use of varenicline in people with schizophrenia to specifically assess tolerability and efficacy for smoking cessation. Specifically, The primary objective of this pilot study is to determine if taking of varenicline along with an individual smoking cessation supportive program is a safe and effective treatment of nicotine addiction in schizophrenic patients. We hypothesize that the varenicline treated patients will achieve higher rates of smoking cessation than those who receive placebo and individual support.


Options:
A: Change of ExpiredCO Level From Baseline (Weekly for 12 weeks); Level of Nicotine Dependence by Treatment Assignment (Weekly for 12 weeks)
B: Percent Compliance With Chantix (Months 1, 2, 3)
C: Days to Relapse (4 weeks)
D: Days of abstinence following the programmed lapse (7 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Varenicline and Placebo for Smoking Cessation in Schizophrenia
Brief Summary: The purpose of this proposed pilot study is to examine the use of varenicline in people with schizophrenia to specifically assess tolerability and efficacy for smoking cessation. Specifically, The primary objective of this pilot study is to determine if taking of varenicline along with an individual smoking cessation supportive program is a safe and effective treatment of nicotine addiction in schizophrenic patients. We hypothesize that the varenicline treated patients will achieve higher rates of smoking cessation than those who receive placebo and individual support.


Options:
A: Change of ExpiredCO Level From Baseline (Weekly for 12 weeks); Level of Nicotine Dependence by Treatment Assignment (Weekly for 12 weeks)
B: 7-Day Point Prevalence Smoking Abstinence (24 weeks); Continuous Smoking Abstinence (24 weeks)
C: Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint (Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.); Estimated NPS AE Rate (%), by Cohort (Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.)
D: Smoking cessation (point prevalence, both self reported as biochemical verified) (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Phase II Feasibility Study of Docetaxel (Taxotere®) Plus Prednisolone vs. Docetaxel (Taxotere®) Plus Prednisolone Plus Zoledronic Acid (Zometa®) vs. Docetaxel (Taxotere®) Plus Prednisolone Plus Strontium-89 vs. Docetaxel (Taxotere®) Plus Prednisolone Plus Zoledronic Acid (Zometa®) Plus Strontium-89 in Hormone Refractory Prostate Cancer Metastatic to Bone.
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisolone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Zoledronic acid may help relieve some of the symptoms caused by bone metastases. Radioactive substances, such as strontium chloride Sr 89, may help relieve bone pain caused by prostate cancer. Giving docetaxel together with prednisolone with or without zoledronic acid and/or strontium chloride Sr 89 may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying the side effects and how well giving docetaxel together with prednisolone works with or without zoledronic acid and/or strontium chloride Sr 89 in treating patients with prostate cancer metastatic to bone that has not responded to hormone therapy.


Options:
A: Time to treatment failure (TTF) (6 years)
B: Safety; Toxicity and tolerability of docetaxel and zoledronic acid; Toxicity and tolerability of docetaxel and strontium chloride Sr 89; Toxicity and tolerability of docetaxel, zoledronic acid, and strontium chloride Sr 89
C: N/A
D: Time to First Skeletal Related Event (Up to 10 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Belatacept as First Line Immunosuppression in De Novo Liver Transplant Recipients
Brief Summary: The purpose of this clinical research study is to evaluate the effects of belatacept, relative to tacrolimus, on the incidence of rejection, graft loss and death in subjects receiving a liver transplant


Options:
A: Estimated Glomerular Filtration Rate (GFR) (month 12)
B: Recurrence free survival (5 year follow up after last patient in)
C: Percentage of Participants Who Experienced at Least One Episode of Acute Rejection (AR), Graft Loss, or Death by 6 Months Post-transplant (At 6 months posttransplant); Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data) (Day 1 (randomization) to Week 104 + within 56 Days after the last infusion/dose, Deaths were monitored up to database lock (20-June-2011)); Number of Participants Who Had AEs of Special Interest During the LTE (Day 1 (randomization) through database lock (20-June-2011)); Number of Participants With Marked Hematology Abnormalities During the LTE (Every 4 weeks from Week 53 to Week 104.); Number of Participants With Marked Liver and Kidney Function Abnormalities During the LTE (Every 4 weeks from Week 53 to Week 104.); Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities During the LTE (Every 4 weeks from Week 53 to Week 104.)
D: Proportion of patients who can significantly decrease the doses of tacrolimus 1 year after transplantation (as defined by: tacrolimus administered on alternate days, or daily with trough levels below 5 ng/mL. (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing Caregiver Support for Patients With Heart Failure
Brief Summary: Informal caregivers, assisted by health information technology may help to fill the gaps in VA care management of heart failure patients by enhancing support for patients' treatment adherence, behavior changes, and symptom monitoring.


Options:
A: Health-related Quality of Life (SF-36v2-acute Form) (9 weeks)
B: Heart Failure-specific Quality of Life (twelve-month followup)
C: Time until all-cause death or heart-failure hospitalization (Measured over the two years of study follow-up.)
D: Total steps (last 30 days of intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing Caregiver Support for Patients With Heart Failure
Brief Summary: Informal caregivers, assisted by health information technology may help to fill the gaps in VA care management of heart failure patients by enhancing support for patients' treatment adherence, behavior changes, and symptom monitoring.


Options:
A: Change in Chronic Heart Failure Health Status Between Baseline and 12 Months. (12 months)
B: Medication Adherence (3 Months)
C: Brain Natriuretic Peptide values (Baseline, 6 months); Self-care practices measured through Self-Care of Heart Failure Index scores and interviews (baseline, 6 months); Health related quality of life measured through the Minnesota Living with Heart Failure Questionnaire scores and interviews (baseline, 6 months)
D: Heart Failure-specific Quality of Life (twelve-month followup)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing Caregiver Support for Patients With Heart Failure
Brief Summary: Informal caregivers, assisted by health information technology may help to fill the gaps in VA care management of heart failure patients by enhancing support for patients' treatment adherence, behavior changes, and symptom monitoring.


Options:
A: Heart Failure-specific Quality of Life (twelve-month followup)
B: Number of Health risk behaviors (3 months); Number of risk behaviors counseled on during primary care appointment (1 day)
C: Trial feasibility measured with number of patients recruited for study who have consented and participate for the duration of the study. (1 year)
D: To investigate whether the use of QOL questionnaires during the assessment and management of lung cancer patients results in improved quality of life

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Staccato® Loxapine for Inhalation in Subjects on Chronic, Stable Antipsychotic Regimens
Brief Summary: The objectives of this trial are to assess the safety, tolerability, and pharmacokinetics of multiple inhaled doses of Staccato Loxapine.


Options:
A: change from baseline in Positive and Negative Syndrome Scale (PANSS) total scores (The PANSS was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).)
B: Positive Syndrome Scale (PANSS) Total Score (Variable change from baseline to week 12); Negative Syndrome Scale (PANSS) Total Score (Variable change from baseline to week 12)
C: Symptomatic improvement of schizophrenia after 8 weeks of treatment in comparison to time of inclusion of patient measured py Positive and Negative Symptom Scale (PANSS) (8 weeks)
D: PK parameters: tmax, Cmax, AUClast, AUCinf, ke, t1/2 and clearance will be estimated for each subject and for the population using noncompartmental methods. (48 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Buprenorphine Maintenance vs. Detoxification in Prescription Opioid Dependence
Brief Summary: The aim of the study is to determine whether buprenorphine/naloxone maintenance versus detoxification using buprenorphine/naloxone, in prescription opioid dependent patients receiving primary care management and drug counseling in an office-based setting, leads to decreased illicit opioid use.


Options:
A: Hepatic Safety (24 Weeks)
B: Self-reported Engagement in Formal Substance Abuse Treatment at 30 Days (Verified by Contact With the Treatment Program) (30 days post randomization)
C: Illicit Opioid Use (18 weeks)
D: Analgesia (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Buprenorphine Maintenance vs. Detoxification in Prescription Opioid Dependence
Brief Summary: The aim of the study is to determine whether buprenorphine/naloxone maintenance versus detoxification using buprenorphine/naloxone, in prescription opioid dependent patients receiving primary care management and drug counseling in an office-based setting, leads to decreased illicit opioid use.


Options:
A: Percentage of patients in each group successfully inducted onto Vivitrol (Completion of 7-day detoxification)
B: Percent of Participants Using Drugs (2 weeks following discharge)
C: Illicit Opioid Use (18 weeks)
D: The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition at End of Phase 1 (12 weeks); The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition, Phase 2 End of Treatment (12 weeks in Phase 2 period (i.e., 24 weeks into the study))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Longitudinal Assessment of Clinical Course and BIOmarkers in Severe Chronic AIRway Disease
Brief Summary: The aim of the project is to study pathogenetic mechanisms in severe asthma and compare those mechanisms in chronic obstructive pulmonary disease (COPD) in order to test the hypothesis that severe asthma and COPD develop into similar chronic degenerative changes.


Options:
A: Number of exacerbations (one year)
B: Asthma Exacerbations (end of 48 week treatment period)
C: Rate of Asthma Exacerbations Per Year (monthly through study completion an average of 15 months)
D: The Number of Participants With a Differential Response to the Three Step-up Therapies Based on Fixed Threshold Criteria for the Following Three Asthma Control Measures: Use of Oral Prednisone for Acute Asthma Exacerbations, Asthma Control Days and FEV1. (Measured during the last 12 weeks of each 16-week treatment period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Can a Behavioural Modifying Intervention Increase the Self-care and the Effect of the Diabetes Treatment in Chronically Ill Patients With Diabetes
Brief Summary: Diabetes is a common condition associated with increased morbidity and mortality. Non-pharmacological intervention strategies focusing on factors to improve self-management skills are considered an important part of the treatment in individuals with diabetes. Because of the increasing incidence in diabetes with costs (both physical, psychological and financial) for both patients and society it is important to investigate interventions that successfully promote self-care behaviour in patient with diabetes. Further research is needed to develop interventions effective in maintaining long-term glycemic control.

The aim of this project is to study the long-term effect of a motivational intervention program with an individual approach based on cognitive-behavioural strategies in chronically ill patients with diabetes. The effect will be evaluated on both physiological and psychosocial parameters including patient's experienced self-care competence.

The study will also provide an overview of what kind of non-pharmacological interventions that have been applied in relation to the treatment of type 2 diabetes and assess the effect of the various non-pharmacological interventions in randomised controlled trials.


Options:
A: Glucose Monitoring Adherence at Acute Outcome (Measured at Month 4); Percent Medication Adherence Via MEMS (month 4); Clinician Rated Depression (MADRS) at the Acute Timepoint (month 4); Depression on the CGI at Acute Outcome (Month 4)
B: Hemoglobin A1c (6 and 12 months)
C: HbA1c (one year)
D: Weight loss (18-months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Multi-Center, Double-Blind, Parallel-Group, Placebo-Controlled Study of NRP104 in Children Aged 6-12 Years With Attention Deficit Hyperactivity Disorder
Brief Summary: This study is designed to assess efficacy and safety of NRP-104 administered as a daily dose of 30mg, 50mg or 70mg compared to placebo in the treatment of children aged 6-12 years with ADHD.


Options:
A: Change score from baseline of the ADHD-RS (4 weeks)
B: Medication Event Monitoring System (MEMS®) Dosage Adherence (The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)); Medication Event Monitoring System (MEMS®) Regimen Adherence (The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)); Medication Event Monitoring System (MEMS®) Time Adherence (The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks))
C: Attention Deficit Hyperactivity Disorder- Rating Scale (ADHS-RS) (12 weeks)
D: Last Three Weeks of Cocaine Abstinence Based on Urine Toxicology Results and Self Reported Use (weekly for 14 weeks of trial or for length of participation); ADHD Symptoms Based on ADHD Rating Scale (measured once per week for 14 weeks or length of study participation)

Answer: A