TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 409306 Film-coated Tablets Given Orally q.d. for 14 Days in Patients With Schizophrenia (Randomized, Parallel-group, Double-blind, Placebo-controlled Study)
Brief Summary: The primary objective of the current study is to investigate the safety and tolerability of BI 409306 in schizophrenic patients following oral administration of multiple low, medium, and high doses over 14 days.

A secondary objective is the exploration of the pharmacokinetics and pharmacodynamics of BI 409306 in schizophrenic patients.


Options:
A: Number of Participants With Drug-related Adverse Events (From first drug administration until 30 days after last drug administration, up to 44 days.)
B: Time to Relapse or an Impending Relapse (time of first relapse up to Day 182 (double blind phase))
C: Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria by the End of Week 26 (Baseline to Week 26)
D: Poor clinical outcome (In one month previous to the final assessment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Double Blind Placebo-controlled Study to Demonstrate That Antibiotics Are Not Needed in Moderate Acute Exacerbations of COPD - The ABACOPD Study
Brief Summary: The ultimate goal is to reduce unnecessary antibiotic prescriptions which drive the development of antibiotic resistance in the community. The primary objective of ABACOPD is to demonstrate in a sufficiently sized clinical study that there is no relevant increase in the "failure-rate" for patients with acute moderate exacerbations of COPD (AE-COPD) treated with placebo instead of antibiotic treatment both on top of standard of care. A patient is classified as treatment failure if additional antibiotic therapy is required during treatment period or until the test of cure visit (TOC at day 30, primary endpoint).


Options:
A: Number of exacerbations after 48 weeks of intermittent pulse treatment (After 48 weeks of treatment)
B: Clinical efficacy at the end of treatment
C: Additional antibiotic therapy to study medication during treatment period or until the test of cure visit (at day 30) (up to day 30)
D: Number of Patients Who Were Cured (Day 9-11)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Tailored Tobacco Intervention
Brief Summary: The project is designed to examine the effectiveness of strategies to increase access to treatment for tobacco use and dependence among rural Veteran smokers. In addition, it will examine whether tailored treatment that is designed to address common comorbid conditions that are related to cigarette smoking enhances success with quitting relative to enhanced standard of care. The investigators hypothesize that participants assigned to the tailored tobacco cessation intervention will report greater cessation rates at six months. The investigators also anticipate more favorable outcomes on measures of depressive symptoms, alcohol use, and body weight.


Options:
A: Toxicant Exposure (6 weeks)
B: Tobacco use (Six-month follow-up)
C: Pharmacokinetic parameters: Population mean estimate for apparent plasma clearance (CL/F), central volume of distribution (V2/F) and steady-state volume of distribution (Vss/F).
D: Continuous abstinence (Russell Standard) (Six months post quit date)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Tailored Tobacco Intervention
Brief Summary: The project is designed to examine the effectiveness of strategies to increase access to treatment for tobacco use and dependence among rural Veteran smokers. In addition, it will examine whether tailored treatment that is designed to address common comorbid conditions that are related to cigarette smoking enhances success with quitting relative to enhanced standard of care. The investigators hypothesize that participants assigned to the tailored tobacco cessation intervention will report greater cessation rates at six months. The investigators also anticipate more favorable outcomes on measures of depressive symptoms, alcohol use, and body weight.


Options:
A: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
B: Tobacco use (Six-month follow-up)
C: 7-day point prevalence of abstinence, 9-12 week continuous abstinence, 9-26 week continuous abstinence (9-12 weeks; 9-26)
D: to assess the continuous abstinence from tobacco smoking at every visit during the last four weeks of treatment through direct inquiry of patients; exhaled carbon monoxide testing; and plasma cotinine measurements

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Tailored Tobacco Intervention
Brief Summary: The project is designed to examine the effectiveness of strategies to increase access to treatment for tobacco use and dependence among rural Veteran smokers. In addition, it will examine whether tailored treatment that is designed to address common comorbid conditions that are related to cigarette smoking enhances success with quitting relative to enhanced standard of care. The investigators hypothesize that participants assigned to the tailored tobacco cessation intervention will report greater cessation rates at six months. The investigators also anticipate more favorable outcomes on measures of depressive symptoms, alcohol use, and body weight.


Options:
A: 7-day Prevalence of Abstinence From Cigarette Smoking at 12 Weeks (12 weeks); 7 Day Prevalence of Abstinence From Cigarette Smoking at 24 Weeks (24 weeks)
B: Tobacco use (Six-month follow-up)
C: Continuous abstinence (Russell Standard) (Six months post quit date)
D: Self-reported continuous abstinence of smoking and exhaled carbon monoxide levels less than 10 ppm as measured and recorded by the research nurse at weeks 12 and 52. (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Tailored Tobacco Intervention
Brief Summary: The project is designed to examine the effectiveness of strategies to increase access to treatment for tobacco use and dependence among rural Veteran smokers. In addition, it will examine whether tailored treatment that is designed to address common comorbid conditions that are related to cigarette smoking enhances success with quitting relative to enhanced standard of care. The investigators hypothesize that participants assigned to the tailored tobacco cessation intervention will report greater cessation rates at six months. The investigators also anticipate more favorable outcomes on measures of depressive symptoms, alcohol use, and body weight.


Options:
A: Prolonged Smoking Abstinence at End of 12 Weeks of Varenicline Treatment (12 weeks)
B: Tobacco use (Six-month follow-up)
C: Quit Rate (4 months)
D: Weight Gain in Treatment Completers (baseline and 12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Tailored Tobacco Intervention
Brief Summary: The project is designed to examine the effectiveness of strategies to increase access to treatment for tobacco use and dependence among rural Veteran smokers. In addition, it will examine whether tailored treatment that is designed to address common comorbid conditions that are related to cigarette smoking enhances success with quitting relative to enhanced standard of care. The investigators hypothesize that participants assigned to the tailored tobacco cessation intervention will report greater cessation rates at six months. The investigators also anticipate more favorable outcomes on measures of depressive symptoms, alcohol use, and body weight.


Options:
A: Smoking Abstinence (week 7, week 11 and week 24 after scheduled quit day)
B: Success rates and safety at week 24 in the varenicline vs placebo. Success rates will be defined as the Continuous Quit Rate since last visit. Maintain abstinence during this period of time with end-expiratory exhaled CO measurements ≤ 10 ppm. (week 24)
C: Tobacco use (Six-month follow-up)
D: Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale (1 week)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Tailored Tobacco Intervention
Brief Summary: The project is designed to examine the effectiveness of strategies to increase access to treatment for tobacco use and dependence among rural Veteran smokers. In addition, it will examine whether tailored treatment that is designed to address common comorbid conditions that are related to cigarette smoking enhances success with quitting relative to enhanced standard of care. The investigators hypothesize that participants assigned to the tailored tobacco cessation intervention will report greater cessation rates at six months. The investigators also anticipate more favorable outcomes on measures of depressive symptoms, alcohol use, and body weight.


Options:
A: To examine the effects of varenicline treatment used concomitantly with antipsychotic medications, on cognitive dysfunction in people with schizophrenia. (8 weeks)
B: Prolonged Smoking Abstinence at End of 12 Weeks of Varenicline Treatment (12 weeks)
C: Tobacco use (Six-month follow-up)
D: Smoking Status (at week 48)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Tailored Tobacco Intervention
Brief Summary: The project is designed to examine the effectiveness of strategies to increase access to treatment for tobacco use and dependence among rural Veteran smokers. In addition, it will examine whether tailored treatment that is designed to address common comorbid conditions that are related to cigarette smoking enhances success with quitting relative to enhanced standard of care. The investigators hypothesize that participants assigned to the tailored tobacco cessation intervention will report greater cessation rates at six months. The investigators also anticipate more favorable outcomes on measures of depressive symptoms, alcohol use, and body weight.


Options:
A: Tobacco use (Six-month follow-up)
B: Change from baseline prevalence of tobacco use at one week and at 2 years [Questionnaire] (One week and Two years after the completion of the intervention)
C: Complete Switching From Combustible Cigarettes to JUUL e-cigarette as measured by Exhaled carbon monoxide (CO) (After 8 weeks); Complete Switching From Combustible Cigarettes to JUUL e-cigarette as measured by change in Total urinary 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) (Baseline, Week 8, Week 12); Complete Switching From Combustible Cigarettes to JUUL e-cigarette as measured by change in self-report of daily cigarette and e-cigarette use (Daily from Week 2 to Week 12)
D: 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)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Tailored Tobacco Intervention
Brief Summary: The project is designed to examine the effectiveness of strategies to increase access to treatment for tobacco use and dependence among rural Veteran smokers. In addition, it will examine whether tailored treatment that is designed to address common comorbid conditions that are related to cigarette smoking enhances success with quitting relative to enhanced standard of care. The investigators hypothesize that participants assigned to the tailored tobacco cessation intervention will report greater cessation rates at six months. The investigators also anticipate more favorable outcomes on measures of depressive symptoms, alcohol use, and body weight.


Options:
A: Tobacco use (Six-month follow-up)
B: To Determine the Safety of Varenicline in PLWH Who Smoke (3 months)
C: 4-week continuous quit rate (CQR) for Weeks 9-12
D: Number of Participants With Smoking Abstinence at Month 6 (Month 6)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Randomized, Controlled Trial Comparing the Safety and Efficacy of AMDC-USR With Placebo in Female Subjects With Stress Urinary Incontinence
Brief Summary: This randomized, double-blind, placebo-controlled, multicenter, confirmatory study will evaluate the efficacy and safety of Cook MyoSite Incorporated Autologous Muscle-Derived Cells (generic name Iltamiocel) compared to a placebo (vehicle) control dose in the treatment of stress urinary incontinence (SUI) in adult female patients.


Options:
A: Participants With ≥ 50% Reduction in Stress Incontinence Episode Frequency From Baseline to 12 Months Post-treatment; as Assessed by 3 Day Diary (Baseline and 12 months)
B: Count of Treatment Responders in the Intent to Treat (ITT) Cohort (3 months)
C: Change from baseline in ovarian function as measured by Anti-Mullerian Hormone (AMH) (AMH blood samples collected prior to surgery at day 1 (the day of the surgery) and at 1 and 3 months after day 1.)
D: Menopause-related quality of life (Up to 5 years after last surgery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Tailored Implementation for Chronic Diseases.
Brief Summary: Background: Chronic Obstructive Pulmonary Disease (COPD) remains a major health problem, which is strongly related to smoking. Despite publication of guidelines on the prevention and treatment of COPD, not all COPD patients receive the best available healthcare. Investigators developed a tailored implementation strategy for improving primary care physicians' adherence to COPD management guidelines. The primary aim of the presented trial is to evaluate the effects of this strategy on physician's performance. The secondary aim is to examine the validity of the tailoring of implementation interventions.

Primary Trial Hypothesis: To study if the rate of adherence to the COPD guideline over a 1 year will increase among participants assigned to the intervention group in comparison to those assigned to the control group?

Methods/Design: A two-arm pragmatic cluster randomized trial is planned. A total of 540 patients with diagnosed COPD will be included from 18 general practices in Poland. A tailored implementation program will be offered to general practitioners. Participating physicians in the intervention practices (n=18) will receive training to provide brief anti-smoking counselling. An additional form containing COPD severity scale will be inserted into patient's medical records. The checklist with key information about the disease and its management while consulting a patient with COPD will be provided to practitioners. Investigators will provide practices with training inhaler devices for general practitioners (GPs) to teach patients in correct use of each device and to note this education/training in patient's medical records. The control practices will provide usual care.

Discussion: The results of this trial will be directly applicable to primary care in Poland and add to the growing body of evidence on interventions to improve chronic illness care.


Options:
A: The percentage of selected patients receiving anti-tabacco counseling recorded by the GPs in the labeled patients' medical records. (1 year)
B: Prevalence of latent heart failure and COPD. (6 months)
C: COPD Assessment Test (CAT) (Baseline and 6 months)
D: "Quality of care process" (one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Tailored Implementation for Chronic Diseases.
Brief Summary: Background: Chronic Obstructive Pulmonary Disease (COPD) remains a major health problem, which is strongly related to smoking. Despite publication of guidelines on the prevention and treatment of COPD, not all COPD patients receive the best available healthcare. Investigators developed a tailored implementation strategy for improving primary care physicians' adherence to COPD management guidelines. The primary aim of the presented trial is to evaluate the effects of this strategy on physician's performance. The secondary aim is to examine the validity of the tailoring of implementation interventions.

Primary Trial Hypothesis: To study if the rate of adherence to the COPD guideline over a 1 year will increase among participants assigned to the intervention group in comparison to those assigned to the control group?

Methods/Design: A two-arm pragmatic cluster randomized trial is planned. A total of 540 patients with diagnosed COPD will be included from 18 general practices in Poland. A tailored implementation program will be offered to general practitioners. Participating physicians in the intervention practices (n=18) will receive training to provide brief anti-smoking counselling. An additional form containing COPD severity scale will be inserted into patient's medical records. The checklist with key information about the disease and its management while consulting a patient with COPD will be provided to practitioners. Investigators will provide practices with training inhaler devices for general practitioners (GPs) to teach patients in correct use of each device and to note this education/training in patient's medical records. The control practices will provide usual care.

Discussion: The results of this trial will be directly applicable to primary care in Poland and add to the growing body of evidence on interventions to improve chronic illness care.


Options:
A: The percentage of selected patients receiving anti-tabacco counseling recorded by the GPs in the labeled patients' medical records. (1 year)
B: Time to Next Asthma or COPD Exacerbation up to 182 Days (182 days)
C: Overall Discrepancy Rate (4-week Treatment Period); Overall Quartile Discrepancy Rate (4-week Treatment Period); Overall Discrepancy Size (4-week Treatment Period); End of Use Agreement: Number of Inhalers With an End of Use Agreement of 0 (Completer Population) (4-week Treatment Period)
D: Short Form Chronic Respiratory Disease Questionnaire (CRQ-SF) Total Score (9 months); Dyspnea Domain Score of the Short Form of the Chronic Respiratory Disease Questionnaire (CRQ-SF) (9 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Tailored Implementation for Chronic Diseases.
Brief Summary: Background: Chronic Obstructive Pulmonary Disease (COPD) remains a major health problem, which is strongly related to smoking. Despite publication of guidelines on the prevention and treatment of COPD, not all COPD patients receive the best available healthcare. Investigators developed a tailored implementation strategy for improving primary care physicians' adherence to COPD management guidelines. The primary aim of the presented trial is to evaluate the effects of this strategy on physician's performance. The secondary aim is to examine the validity of the tailoring of implementation interventions.

Primary Trial Hypothesis: To study if the rate of adherence to the COPD guideline over a 1 year will increase among participants assigned to the intervention group in comparison to those assigned to the control group?

Methods/Design: A two-arm pragmatic cluster randomized trial is planned. A total of 540 patients with diagnosed COPD will be included from 18 general practices in Poland. A tailored implementation program will be offered to general practitioners. Participating physicians in the intervention practices (n=18) will receive training to provide brief anti-smoking counselling. An additional form containing COPD severity scale will be inserted into patient's medical records. The checklist with key information about the disease and its management while consulting a patient with COPD will be provided to practitioners. Investigators will provide practices with training inhaler devices for general practitioners (GPs) to teach patients in correct use of each device and to note this education/training in patient's medical records. The control practices will provide usual care.

Discussion: The results of this trial will be directly applicable to primary care in Poland and add to the growing body of evidence on interventions to improve chronic illness care.


Options:
A: The two primary outcomes are disease-specific quality of life assessed with the St. George's Respiratory Questionnaire (SGRQ) and the total number of exacerbations
B: Health related quality of life (12 month follow-up); Incremental cost-effectiveness ratio (ICER) (12 month follow-up)
C: Physical activity (Change between baseline (T0) and directly after the intervention, after 4-6 months from baseline (T1)); Physical activity (Change between T1 and T2: 3 months follow up)
D: The percentage of selected patients receiving anti-tabacco counseling recorded by the GPs in the labeled patients' medical records. (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Tailored Implementation for Chronic Diseases.
Brief Summary: Background: Chronic Obstructive Pulmonary Disease (COPD) remains a major health problem, which is strongly related to smoking. Despite publication of guidelines on the prevention and treatment of COPD, not all COPD patients receive the best available healthcare. Investigators developed a tailored implementation strategy for improving primary care physicians' adherence to COPD management guidelines. The primary aim of the presented trial is to evaluate the effects of this strategy on physician's performance. The secondary aim is to examine the validity of the tailoring of implementation interventions.

Primary Trial Hypothesis: To study if the rate of adherence to the COPD guideline over a 1 year will increase among participants assigned to the intervention group in comparison to those assigned to the control group?

Methods/Design: A two-arm pragmatic cluster randomized trial is planned. A total of 540 patients with diagnosed COPD will be included from 18 general practices in Poland. A tailored implementation program will be offered to general practitioners. Participating physicians in the intervention practices (n=18) will receive training to provide brief anti-smoking counselling. An additional form containing COPD severity scale will be inserted into patient's medical records. The checklist with key information about the disease and its management while consulting a patient with COPD will be provided to practitioners. Investigators will provide practices with training inhaler devices for general practitioners (GPs) to teach patients in correct use of each device and to note this education/training in patient's medical records. The control practices will provide usual care.

Discussion: The results of this trial will be directly applicable to primary care in Poland and add to the growing body of evidence on interventions to improve chronic illness care.


Options:
A: Adherence to guidelines G10 and G17 of the 2003 International Consensus Guidelines on nonvariceal upper GI bleeding. (1 year)
B: Incidence of adverse events (count incidence of Pressure Ulcers, Urinary Tract Infections, and Falls (nine months)
C: Changes in a set of predefined quality indicators measuring appropriateness of prescriptions for elderly out-patients (1 year)
D: The percentage of selected patients receiving anti-tabacco counseling recorded by the GPs in the labeled patients' medical records. (1 year)

Answer: D