TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Open-Label Controlled Trial of a 4-Month Gatifloxacin-Containing Regimen Versus Standard Regimen for the Treatment of Adult Patients With Pulmonary Tuberculosis
Brief Summary: Tuberculosis is currently treated with a 6-month course regimen. During this time many patients might fail to adhere to treatment and default, increasing the risk of recurrent disease which might be multidrug resistant. A shorter duration of treatment is expected to provide improved patient compliance and at least equal or better clinical outcome. The aim of the trial is to evaluate the efficacy and safety of a gatifloxacin-containing regimen of four months duration for the treatment of pulmonary tuberculosis,


Options:
A: The Time to Sputum Culture Conversion at Week 8 (Stage 1) (Week 8, Stage 1); The Time to Sputum Culture Conversion at Week 24 (Stage 2) (Week 24, Stage 2)
B: Efficacy: Percentage of relapses by 24 months following treatment cure; Safety: Percentage of adverse events
C: Proportion of Patients With Sterile Sputum Cultures (8 weeks)
D: Early Bactericidal Activity (EBA) Measured as the Mean Rate of Change of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 0-14). (14 consecutive days of treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Open-Label Controlled Trial of a 4-Month Gatifloxacin-Containing Regimen Versus Standard Regimen for the Treatment of Adult Patients With Pulmonary Tuberculosis
Brief Summary: Tuberculosis is currently treated with a 6-month course regimen. During this time many patients might fail to adhere to treatment and default, increasing the risk of recurrent disease which might be multidrug resistant. A shorter duration of treatment is expected to provide improved patient compliance and at least equal or better clinical outcome. The aim of the trial is to evaluate the efficacy and safety of a gatifloxacin-containing regimen of four months duration for the treatment of pulmonary tuberculosis,


Options:
A: The Rate of Change in Colony Forming Units (CFUs) Using Non-linear Mixed Effects Modeling of the Serial Sputum Colony Counts (SSCC) Over 8 Weeks of Treatment. (8 weeks)
B: Evaluation of safety and tolerability of escalating single oral doses of PNU-100480. (Daily, Days 1-3 or 4, and 7-14 days after dosing.)
C: Efficacy: Percentage of relapses by 24 months following treatment cure; Safety: Percentage of adverse events
D: The Time to Sputum Culture Conversion at Week 8 (Stage 1) (Week 8, Stage 1); The Time to Sputum Culture Conversion at Week 24 (Stage 2) (Week 24, Stage 2)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: CONSTATRE: Risperdal Consta Trial Of Relapse Prevention And Effectiveness
Brief Summary: The purpose of this study is to investigate whether a long-acting injectable formulation of risperidone provides better effectiveness over 2 years, as measured by the time to relapse, compared with quetiapine tablets in a routine psychiatric care setting. Aripiprazole will be investigated in a descriptive manner.


Options:
A: Mean Relapse Free Period(Risperidone LAI Versus Quetiapine) (Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Week 104 or earlier))
B: Change Over Time in Frequency of Heavy Drinking Days (Used to Evaluate Treatment Efficacy) (6 months)
C: Acute efficacy: Change in Young Mania Rating Scale (YMRS) total score from baseline to endpoint of 3 weeks of acute treatment period.
D: Mood symptom improvement. (Baseline to exit); Cocaine or methamphetamine cravings and use. (Baseline to exit)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Severe Alzheimer's Disease in a Residential Home, Nursing Home, or Geriatric Residential Setting: Evaluation of Efficacy and Safety of Galantamine Hydrobromide in a Randomised, Doubleblind, Placebo-Controlled Study.
Brief Summary: The purpose of this study is to assess the effectiveness and safety of galantamine hydrobromide treatment in patients with severe Alzheimer's disease.


Options:
A: Change in scores from baseline to week 26 on measuring cognition Severe Impairment Battery test and the Minimum Data Set Activities of Daily Living test.
B: Change From Baseline in Severe Impairment Battery (SIB) at Week 24 (LOCF) (Baseline to week 24); Clinician's Interview-Based Impression of Change With Caregiver Input (CIBIC-plus) at Week 24 (LOCF) (Week 24)
C: Decisional Conflict Scale (3 months)
D: Change From Baseline in the Mini-Mental State Examination (MMSE) Score (Baseline, Month 24); The Number of Deaths Reported in Participants (Up to 2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Severe Alzheimer's Disease in a Residential Home, Nursing Home, or Geriatric Residential Setting: Evaluation of Efficacy and Safety of Galantamine Hydrobromide in a Randomised, Doubleblind, Placebo-Controlled Study.
Brief Summary: The purpose of this study is to assess the effectiveness and safety of galantamine hydrobromide treatment in patients with severe Alzheimer's disease.


Options:
A: Changes in Neuropsychiatric Inventory (24 weeks); Changes in Cornell's Depression Scale (24 weeks); Changes in UPDRS subscale (24 weeks)
B: Decisional Conflict Scale (3 months)
C: Change From Baseline in Severe Impairment Battery (SIB) at Week 24 (LOCF) (Baseline to week 24); Clinician's Interview-Based Impression of Change With Caregiver Input (CIBIC-plus) at Week 24 (LOCF) (Week 24)
D: Change in scores from baseline to week 26 on measuring cognition Severe Impairment Battery test and the Minimum Data Set Activities of Daily Living test.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Calcipotriol Plus Betamethasone Dipropionate Gel Compared to Betamethasone Dipropionate in the Gel Vehicle and Calcipotriol in the Gel Vehicle in Scalp Psoriasis
Brief Summary: The purpose of the study is to evaluate whether once daily topical treatment for up to 8 weeks of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel is safe and more effective than betamethasone 0.5 mg/g (as dipropionate) in the gel vehicle and calcipotriol 50 mcg/g in the gel vehicle in patients with scalp psoriasis.

The primary response criterion is the number of patients with absence of disease and very mild disease after 8 weeks of treatment.


Options:
A: Number of Subjects With Treatment Success, Assessed Per the Investigator's Static Global Assessment (ISGA) (8 weeks)
B: - Patients with "Controlled disease" ("Absence of disease" or "Very mild disease") according to investigator's global assessment of disease severity at week 8.
C: Difference in percent reduction in Psoriasis Area and Severity Index (PASI) Scores between treatment arms (12 weeks of treatment)
D: Number of Subjects With Treatment Success, Assessed Per the Investigator's Static Global Assessment (8 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Statin Choice Decision Aid and Its Effects on Statin Decisions in Patients With Type 2 Diabetes Mellitus. A Clustered Randomized Trial
Brief Summary: Background- Statins are a safe and effective therapy to reduce cardiovascular risk in patients with type 2 diabetes; however some patients are not prescribed statins, others do not take it even after being prescribed, and others stop therapy prematurely. Lack of knowledge or misinformation about statins may be responsible for inadequate statin use.

Objective- To test the hypothesis that a formal, structured decision aid could correct deficiencies in the current decision-making process, increase statin use, and improve outcomes in patients with type 2 diabetes.

Methods - The investigators will develop a decision aid called STATIN CHOICE and will pilot its efficacy in a blinded randomized controlled trial enrolling 98 type 2 diabetes patients.

Outcomes- Primary outcomes: adherence to the decision to use or not to use statins three months after using STATIN CHOICE. Secondary outcomes: acceptability of STATIN CHOICE, knowledge about options, satisfaction with decisions, decisional conflict, encounter duration, and quality of life.

Expected results- The investigators anticipate that this work will yield an effective and innovative decision aid for statin use in type 2 diabetes patients. STATIN CHOICE, along with a detailed users manual, will be directly applicable in clinical practice. Data and experience from this project will inform the planning and conduct of a randomized multicenter trial of the effectiveness of STATIN CHOICE in diverse practice settings.

Significance- Patient participation in decision-making resulting in informed treatment decisions, as proposed in this study, will likely lead to improved quality of decision-making, more appropriate use of statins, and improved patient outcomes.


Options:
A: Development and testing of a decision aid that describes the risks and benefits of taking tamoxifen citrate to prevent primary breast cancer
B: Adherence to the decision to use or not to use statins
C: N/A
D: Physical Activity (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Statin Choice Decision Aid and Its Effects on Statin Decisions in Patients With Type 2 Diabetes Mellitus. A Clustered Randomized Trial
Brief Summary: Background- Statins are a safe and effective therapy to reduce cardiovascular risk in patients with type 2 diabetes; however some patients are not prescribed statins, others do not take it even after being prescribed, and others stop therapy prematurely. Lack of knowledge or misinformation about statins may be responsible for inadequate statin use.

Objective- To test the hypothesis that a formal, structured decision aid could correct deficiencies in the current decision-making process, increase statin use, and improve outcomes in patients with type 2 diabetes.

Methods - The investigators will develop a decision aid called STATIN CHOICE and will pilot its efficacy in a blinded randomized controlled trial enrolling 98 type 2 diabetes patients.

Outcomes- Primary outcomes: adherence to the decision to use or not to use statins three months after using STATIN CHOICE. Secondary outcomes: acceptability of STATIN CHOICE, knowledge about options, satisfaction with decisions, decisional conflict, encounter duration, and quality of life.

Expected results- The investigators anticipate that this work will yield an effective and innovative decision aid for statin use in type 2 diabetes patients. STATIN CHOICE, along with a detailed users manual, will be directly applicable in clinical practice. Data and experience from this project will inform the planning and conduct of a randomized multicenter trial of the effectiveness of STATIN CHOICE in diverse practice settings.

Significance- Patient participation in decision-making resulting in informed treatment decisions, as proposed in this study, will likely lead to improved quality of decision-making, more appropriate use of statins, and improved patient outcomes.


Options:
A: Quality of care process index = ∑ of recommended services received by patient/ ∑ of the recommended services for which the patient was eligible (5 years)
B: Predicted 10-year CHD risk (4-month follow-up)
C: Physical activity (4 years); Modelled cardiovascular risk (4 years); Health related quality of life (4 years); Functional capacity (4 years)
D: Adherence to the decision to use or not to use statins

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Statin Choice Decision Aid and Its Effects on Statin Decisions in Patients With Type 2 Diabetes Mellitus. A Clustered Randomized Trial
Brief Summary: Background- Statins are a safe and effective therapy to reduce cardiovascular risk in patients with type 2 diabetes; however some patients are not prescribed statins, others do not take it even after being prescribed, and others stop therapy prematurely. Lack of knowledge or misinformation about statins may be responsible for inadequate statin use.

Objective- To test the hypothesis that a formal, structured decision aid could correct deficiencies in the current decision-making process, increase statin use, and improve outcomes in patients with type 2 diabetes.

Methods - The investigators will develop a decision aid called STATIN CHOICE and will pilot its efficacy in a blinded randomized controlled trial enrolling 98 type 2 diabetes patients.

Outcomes- Primary outcomes: adherence to the decision to use or not to use statins three months after using STATIN CHOICE. Secondary outcomes: acceptability of STATIN CHOICE, knowledge about options, satisfaction with decisions, decisional conflict, encounter duration, and quality of life.

Expected results- The investigators anticipate that this work will yield an effective and innovative decision aid for statin use in type 2 diabetes patients. STATIN CHOICE, along with a detailed users manual, will be directly applicable in clinical practice. Data and experience from this project will inform the planning and conduct of a randomized multicenter trial of the effectiveness of STATIN CHOICE in diverse practice settings.

Significance- Patient participation in decision-making resulting in informed treatment decisions, as proposed in this study, will likely lead to improved quality of decision-making, more appropriate use of statins, and improved patient outcomes.


Options:
A: First occurrence of fatal or non-fatal acute MI, unstable angina, stroke, congestive heart failure, or revascularization (coronary bypass, stent insertion, or angioplasty) (2.5 years)
B: Adherence to medication; self-reported current use of antiplatelet, statin and combination (≥ 2) blood pressure lowering therapy (End of trial follow-up); Change in blood pressure (End of trial follow-up); Change in LDL cholesterol (End of trial follow-up)
C: 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)
D: Adherence to the decision to use or not to use statins

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Statin Choice Decision Aid and Its Effects on Statin Decisions in Patients With Type 2 Diabetes Mellitus. A Clustered Randomized Trial
Brief Summary: Background- Statins are a safe and effective therapy to reduce cardiovascular risk in patients with type 2 diabetes; however some patients are not prescribed statins, others do not take it even after being prescribed, and others stop therapy prematurely. Lack of knowledge or misinformation about statins may be responsible for inadequate statin use.

Objective- To test the hypothesis that a formal, structured decision aid could correct deficiencies in the current decision-making process, increase statin use, and improve outcomes in patients with type 2 diabetes.

Methods - The investigators will develop a decision aid called STATIN CHOICE and will pilot its efficacy in a blinded randomized controlled trial enrolling 98 type 2 diabetes patients.

Outcomes- Primary outcomes: adherence to the decision to use or not to use statins three months after using STATIN CHOICE. Secondary outcomes: acceptability of STATIN CHOICE, knowledge about options, satisfaction with decisions, decisional conflict, encounter duration, and quality of life.

Expected results- The investigators anticipate that this work will yield an effective and innovative decision aid for statin use in type 2 diabetes patients. STATIN CHOICE, along with a detailed users manual, will be directly applicable in clinical practice. Data and experience from this project will inform the planning and conduct of a randomized multicenter trial of the effectiveness of STATIN CHOICE in diverse practice settings.

Significance- Patient participation in decision-making resulting in informed treatment decisions, as proposed in this study, will likely lead to improved quality of decision-making, more appropriate use of statins, and improved patient outcomes.


Options:
A: Adherence to the decision to use or not to use statins
B: Quality of Decision Making (Immediately following each patient's index visit and before they leave the clinic on that day, typically within 10 minutes of completing the clinical encounter.); Knowledge Transfer (Immediately following each patient's index visit and before they leave the clinic on that day, typically within 10 minutes of completing the clinical encounter.)
C: Understanding (Directly proceeding the clinical encounter); Decisional Conflict (Directly proceeding the clinical visit); Treatment Action, adherence (Directly proceeding the clinical encounter, 6 months after the clinical encounter)
D: Efficacy of the PCI Choice Decision aid vs. Usual Care assessed by Patient and Provider Surveys, and encounter Video/Audio Recordings (Baseline to Three Months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial To Assess Safety And Efficacy Of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) In Adults Aged 60 Years And Older CAIV-T, Liquid Formulation
Brief Summary: The purpose of this study is to determine the efficacy, safety and tolerability of the liquid formulation of CAIV-T against culture confirmed influenza illness in adults aged 60 years and older. In addition this study aims to demonstrate superiority of CAIV-T when compared with placebo and the effect on economic resources.


Options:
A: Evaluate immunogenicity and safety of influenza A （H1N1）vaccines in elders, adults, adolescent and children . (July 2009- Sept. 2009)
B: The appearance among patients of symptomatic laboratory-confirmed influenza. (Influenza season Nov-Apr. Within 72 hours of illness onset throat swab specimens will be obtained from participants with influenza like illness (ILI).)
C: The primary study endpoint was the comparison of efficacy of CAIV-T versus placebo against culture-confirmed influenza-illness caused by community-acquired influenza subtypes that were antigenically similar to those contained in the vaccine.
D: Hemagglutination inhibition antibody titer (D0,D21,D35)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: To evaluate a model of shared decision-making for asthma treatment, appropriate to the needs of African American, Latino, Chinese, and other Asian and low income Caucasian patients to adherence to asthma controller medications in a two-year randomized clinical trial in 302 minority and low-income adults, 18-70 years of age, with suboptimally controlled, persistent asthma, paralleling a simultaneous evaluation being conducted in 311 Caucasian and Asian/Pacific Island adults, (total n=613), and to examine psychological mechanisms mediating the effects of the intervention on adherence and of adherence on asthma outcomes.


Options:
A: N/A
B: N/A
C: Step-count bout ratio = 7 day average of steps taken during 10 minute bouts in one day divided by total steps taken during the same day
D: Change in systolic blood pressure; change in Hemoglobin A1C; change in low density lipoprotein (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: To evaluate a model of shared decision-making for asthma treatment, appropriate to the needs of African American, Latino, Chinese, and other Asian and low income Caucasian patients to adherence to asthma controller medications in a two-year randomized clinical trial in 302 minority and low-income adults, 18-70 years of age, with suboptimally controlled, persistent asthma, paralleling a simultaneous evaluation being conducted in 311 Caucasian and Asian/Pacific Island adults, (total n=613), and to examine psychological mechanisms mediating the effects of the intervention on adherence and of adherence on asthma outcomes.


Options:
A: N/A
B: Symptom-free days; Quality of Life Questionnaire (AQLQ, PAQLQ); Rate of asthma-related hospitalizations over 18 months of enrollment; Rate of asthma-related emergency room (ER) visits over 18 months of enrollment
C: N/A
D: Asthma Quality of Life Questionnaire (Baseline, 6 weeks, 3 months, 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: To evaluate a model of shared decision-making for asthma treatment, appropriate to the needs of African American, Latino, Chinese, and other Asian and low income Caucasian patients to adherence to asthma controller medications in a two-year randomized clinical trial in 302 minority and low-income adults, 18-70 years of age, with suboptimally controlled, persistent asthma, paralleling a simultaneous evaluation being conducted in 311 Caucasian and Asian/Pacific Island adults, (total n=613), and to examine psychological mechanisms mediating the effects of the intervention on adherence and of adherence on asthma outcomes.


Options:
A: N/A
B: Patient Perception of Shared Decision Making (18 months)
C: quality of life (9 months)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: To evaluate a model of shared decision-making for asthma treatment, appropriate to the needs of African American, Latino, Chinese, and other Asian and low income Caucasian patients to adherence to asthma controller medications in a two-year randomized clinical trial in 302 minority and low-income adults, 18-70 years of age, with suboptimally controlled, persistent asthma, paralleling a simultaneous evaluation being conducted in 311 Caucasian and Asian/Pacific Island adults, (total n=613), and to examine psychological mechanisms mediating the effects of the intervention on adherence and of adherence on asthma outcomes.


Options:
A: Medication adherence (At Month 12)
B: MEMS Adherence (12 months follow up)
C: N/A
D: Blood Pressure and Hemaglobin A1c

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: To evaluate a model of shared decision-making for asthma treatment, appropriate to the needs of African American, Latino, Chinese, and other Asian and low income Caucasian patients to adherence to asthma controller medications in a two-year randomized clinical trial in 302 minority and low-income adults, 18-70 years of age, with suboptimally controlled, persistent asthma, paralleling a simultaneous evaluation being conducted in 311 Caucasian and Asian/Pacific Island adults, (total n=613), and to examine psychological mechanisms mediating the effects of the intervention on adherence and of adherence on asthma outcomes.


Options:
A: N/A
B: Number of Participants With Unscheduled Use of Healthcare (1 year)
C: N/A
D: change in asthma control between baseline and six months as measured by ACQ.24 The ACQ measures clinical goals of asthma management on a scale: 0 (good control) to 6, is responsive to change,24 with a intra-individual minimum important difference (6 months)

Answer: A