TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-week, Multicenter, Randomized, Double-Blind, Parallel-Group Study of the Combination of ABT-335 and Rosuvastatin Compared to ABT-335 and Rosuvastatin Monotherapy in Subjects With Type IIa and IIb Dyslipidemia
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of ABT-335 and rosuvastatin calcium combination therapy to monotherapy in subjects with dyslipidemia.


Options:
A: Median Percent Change in Triglycerides From Baseline to Week 8. (Baseline to 8 weeks)
B: Mean Percent Change From Baseline to the Final Visit in High-density Lipoprotein Cholesterol (HDL-C) (Full Analysis Set) (Baseline to 12 Weeks); Mean Percent Change From Baseline to the Final Visit in Triglycerides (Full Analysis Set) (Baseline to 12 Weeks); Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set) (Baseline to 12 Weeks)
C: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks Combination Treatment (Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward))
D: Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline (Day 0) to the End of the 12-week Double-blind Treatment Phase (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Comparative Effects and Expenses of a Proactive Nurse-Led, Multifactorial and Interdisciplinary Team Approach to Falls Prevention for Older At-Risk Home Care Clients
Brief Summary: With an aging population, an associated increase in the number of falls and fall injuries, there is a need to examine how health care services, such as home care, can best prevent falls among older people. This project will directly address this area by evaluating the effects and expense of an innovative approach to home care service delivery for older people at-risk for falls.


Options:
A: Number of self-reported falls: Falls surveillance report (10 minutes)
B: Primary outcomes are number of falls and falls rates as well as number and incidence of injurious falls measured by monthly fall calendars (24 months)
C: Fall incidence (3 months)
D: fall incidence rate

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Comparative Effects and Expenses of a Proactive Nurse-Led, Multifactorial and Interdisciplinary Team Approach to Falls Prevention for Older At-Risk Home Care Clients
Brief Summary: With an aging population, an associated increase in the number of falls and fall injuries, there is a need to examine how health care services, such as home care, can best prevent falls among older people. This project will directly address this area by evaluating the effects and expense of an innovative approach to home care service delivery for older people at-risk for falls.


Options:
A: Number of self-reported falls: Falls surveillance report (10 minutes)
B: Physical activity measured by pedometer. (2 years); Healthy eating index quantified by the Food Frequency Questionnaire. (2 years)
C: Time to Service Disengagement (12 months)
D: a weight loss of 7% in at least 19% of the subjects (one year); reduced body weight of at least 5.6 kg in at least 25% of the subjects (one year); an increase in the level of physical activity by at least 150 minutes per week in at least 29% of the subjects (one year); a reduced daily caloric intake of at least 450 kcal/jour in at least 25% of the subjects (one year); a reduced percentage of the calories introduced in the form of fat of at least 6.6%, in absolute value, in at least 25% of the subjects (one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Single-dose, Dose-ascending, Double Blind, Placebo-controlled, 5-way Crossover Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled Doses of GW642444M With Magnesium Stearate in Asthmatic Patients
Brief Summary: This study will involve the use of a new compound, GW642444 that is being developed for the treatment of asthma and chronic obstructive pulmonary disease (COPD). It works by acting on cells in the lungs, causing some of the muscles around the lungs to relax and open up better (bronchodilation), making breathing easier. When a medicine is made into a form ready to be given to patients, the active ingredient is often prepared with another ingredient called a salt to help make it stable, and inactive ingredients are often added. Inactive ingredients might be used to help a medicine work better, to make it easier to produce the medicine, or to make it easier to get an accurate dose of medicine. In previous studies the study drug has been given as a dry powder containing either the "H" salt (with the inactive ingredient lactose), or containing the "M" salt (with the inactive ingredients lactose and cellobiose octaacetate). The "M" salt form of the study drug has been altered to contain lactose and a new inactive ingredient called magnesium stearate (instead of cellobiose octaacetate).

Participants in this study will receive both the "H" salt (GW642444H) and the new "M" salt (GW642444M) containing magnesium stearate. This study will be the first time the new "M" salt form of the study drug will be given to asthmatic patients.


Options:
A: Mean Annual Rate of Moderate or Severe COPD Exacerbations (Up to 54 weeks)
B: General safety and tolerability of the new formulation of GW642444 as measured by ECG, blood pressure, pulse rate and blood and urine tests. Serial measurements are made over 24 hours on 5 separate occasions (separated by 1 - 2 weeks). (Serial measurements are made over 24 hours on 5 separate occasions (separated by 1 - 2 weeks).)
C: Safety：adverse events, vital sign, ECGs, and clinical laboratory test; PK：Cmax, tmax and AUC(0-t)
D: Change in evening PEF (Daily throughout the 12 week treatment period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Magnesium Sulfate Versus Placebo for Tocolysis in Preterm Premature Rupture of Membranes
Brief Summary: Study compares the outcomes of women between 26 and 32 wks gestation with rupture of membranes. Women randomized to receive tocolysis with magnesium sulfate x 48 hrs or placebo of saline IV x 48 hrs. Antibiotics and antenatal steroids given to both groups.


Options:
A: The time of delivery (6 months)
B: Time to delivery (through study completion, approximately 1 year); Gestational age (through study completion, approximately 1 year)
C: N/A
D: hours of latency to delivery (0 hours to > 168 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Topiramate for Treatment of Patients With Borderline Personality Disorder and Alcohol Dependence
Brief Summary: The objective of the present study is to evaluate the efficacy of topiramate (250mg/day) versus placebo in decreasing aggression and reducing alcohol consumption in patients with borderline personality disorder (BPD) and alcohol dependence (AD).


Options:
A: Parasuicidal behaviour (intermittent)
B: Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) (baseline, weekly until week 8); Montgomery-Åsberg Depression Rating Scale (MADRS) (baseline to 8 weeks); Borderline Evaluation of Severity Over Time (BEST) (Baseline to 8 weeks); Overt Aggression Scale - Modified (OAS-M) (Change from Baseline Overt Aggression Scale - Modified to 8 weeks); Global Assessment of Functioning Scale (GAF) (Change in Global Assessment of Functioning from Baseline to 8 weeks); Barratt Impulsiveness Scale (BIS) (Change in Impulsiveness from Baseline to 8 weeks); Symptom Checklist -90-Revised (SCL-90-R) (Change in psychological problems and symptoms from Baseline to 8 weeks); Young Mania Rating Scale (YMS) (Change in manic symptoms from Baseline to 8 weeks); Sheehan Disability Scale (SDS) (Change in functional impairment from Baseline to 8 weeks)
C: drinking - measured using the TLFB (12 weeks); craving - measured using the OCDS (12 weeks); aggression - measured using the STAE (12 weeks)
D: Suicide Attempt Self-Injury Interview (SASII) (4 months, 8 months and 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Topiramate for Treatment of Patients With Borderline Personality Disorder and Alcohol Dependence
Brief Summary: The objective of the present study is to evaluate the efficacy of topiramate (250mg/day) versus placebo in decreasing aggression and reducing alcohol consumption in patients with borderline personality disorder (BPD) and alcohol dependence (AD).


Options:
A: EPs during BART (Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS)
B: MHS heavy use (2 years)
C: Zanarini Rating Scale for Borderline Personality Disorder (Change from baseline through weeks 2-12, 6 month follow-up, 9 month follow-up, 12 month follow-up)
D: drinking - measured using the TLFB (12 weeks); craving - measured using the OCDS (12 weeks); aggression - measured using the STAE (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Phase II Trial With Cetuximab and Cisplatin in the Treatment of ER-negative, PgR-negative, HER2-negative Metastatic Breast Carcinoma ("Basal Like")
Brief Summary: The primary objective of this study is to determine whether overall response to cetuximab combined with cisplatin is better than overall response to cisplatin alone together with showing that the overall response for cetuximab and cisplatin was above a pre-specified threshold of 0.2 in the treatment of "triple negative" metastatic breast cancer.

The secondary objective of this study is to compare the differences between the two treatment groups using the following criteria : Progression-Free Survival (PFS) Time, Overall Survival (OS), Time to Response (TTR) and Safety.


Options:
A: Safety/Toxicity (End of treatment)
B: PFS (Progression Free Survival) (6 weeks)
C: Establish the safety and tolerability of AZD2281 in combination with cisplatin and gemcitabine in patients with solid tumors. Establish the maximum tolerated dose (MTD) for the combination of AZD2281 with cisplation and gemcitabine.
D: Best Overall Response (BOR) (Evaluations were performed every 6 weeks until progression reported between day of first participant randomized, 20 June 2007, until cut-off date, 31 July 2009)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to evaluate the effect of two different maintenance doses of Symbicort Maintenance And Reliever Therapy (SMART) in adult asthmatic patients. A 6 month treatment period


Options:
A: Number of Severe Asthma Exacerbations Per Participant. (6 months)
B: Time to first severe asthma exacerbation
C: The primary outcome for comparison across treatment groups was the mean value of morning PEF measured during the last 2 weeks of treatment (weeks 23-24)
D: Time to first severe asthma exacerbation

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to evaluate the effect of two different maintenance doses of Symbicort Maintenance And Reliever Therapy (SMART) in adult asthmatic patients. A 6 month treatment period


Options:
A: Time to first severe asthma exacerbation
B: Number of Severe Asthma Exacerbations Per Participant. (6 months)
C: Change in PD20 histamine
D: Time to first severe asthma exacerbation

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Multiple-Dose Pharmacokinetics, Safety and Tolerability of Varenicline in Healthy Adolescent Smokers
Brief Summary: This study will investigate the multiple dose pharmacokinetics, safety, and tolerability of two dose strengths of varenicline in adolescents aged 12 to 16 years who regularly smoke at least three cigarettes per day.


Options:
A: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
B: 52-Week Point-Prevalence Abstinence (Assessed 52 weeks after quit date)
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: Long term abstinence (one year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Multiple-Dose Pharmacokinetics, Safety and Tolerability of Varenicline in Healthy Adolescent Smokers
Brief Summary: This study will investigate the multiple dose pharmacokinetics, safety, and tolerability of two dose strengths of varenicline in adolescents aged 12 to 16 years who regularly smoke at least three cigarettes per day.


Options:
A: Long term abstinence (one year)
B: 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).
C: Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period
D: Hamilton Depression Rating Scale (Ham-D) (Week 8); Memory Saccadic Positional Error, Degrees (Week 8); Predictive Pursuit Gain (Week 8); Maintenance Pursuit Gain (Week 8); Digit Symbol Test (Week 0, Week 2 and Week 8); Conner's Continuous Performance Test (CPT) Detectability Score (Week 0, Week 2 and Week 8); Antisaccade Error Rates (Week 0, Week 2 and Week 8); P50 (Week 0, Week 2 and Week 8)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Multiple-Dose Pharmacokinetics, Safety and Tolerability of Varenicline in Healthy Adolescent Smokers
Brief Summary: This study will investigate the multiple dose pharmacokinetics, safety, and tolerability of two dose strengths of varenicline in adolescents aged 12 to 16 years who regularly smoke at least three cigarettes per day.


Options:
A: effectiveness (2 years)
B: 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).
C: Continuous Abstinence Rate (CAR) From Week 9 Through Week 12 (Week 9 through Week 12)
D: Smoking status at 6 months after enrollment (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Multiple-Dose Pharmacokinetics, Safety and Tolerability of Varenicline in Healthy Adolescent Smokers
Brief Summary: This study will investigate the multiple dose pharmacokinetics, safety, and tolerability of two dose strengths of varenicline in adolescents aged 12 to 16 years who regularly smoke at least three cigarettes per day.


Options:
A: To Determine the Safety of Varenicline in PLWH Who Smoke (3 months)
B: Smoking abstinence at 6 months after inclusion (yes/no) (6 months after inclusion)
C: Number of participants with 7-day point prevalence smoking abstinence (52 weeks)
D: 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).

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Multiple-Dose Pharmacokinetics, Safety and Tolerability of Varenicline in Healthy Adolescent Smokers
Brief Summary: This study will investigate the multiple dose pharmacokinetics, safety, and tolerability of two dose strengths of varenicline in adolescents aged 12 to 16 years who regularly smoke at least three cigarettes per day.


Options:
A: Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. (Week 12)
B: 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).
C: Varenicline Adherence as Measured by Pill Count (Weeks 0-1, 1-2, 2-3, 4-6, 7-9, 10-12)
D: Biochemically verified 7 day point prevalence abstinence from smoking.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Multiple-Dose Pharmacokinetics, Safety and Tolerability of Varenicline in Healthy Adolescent Smokers
Brief Summary: This study will investigate the multiple dose pharmacokinetics, safety, and tolerability of two dose strengths of varenicline in adolescents aged 12 to 16 years who regularly smoke at least three cigarettes per day.


Options:
A: Number of Participants With Smoking Abstinence at Month 6 (Month 6)
B: 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).
C: Smoking Cessation at 7 days (7-day point prevalence abstinence); Continuous Smoking Abstinence at 6 weeks (6 weeks)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Multiple-Dose Pharmacokinetics, Safety and Tolerability of Varenicline in Healthy Adolescent Smokers
Brief Summary: This study will investigate the multiple dose pharmacokinetics, safety, and tolerability of two dose strengths of varenicline in adolescents aged 12 to 16 years who regularly smoke at least three cigarettes per day.


Options:
A: Self reported quit status (Student identifies self as non-smoker and no smoking for 30 days) (End of program and 1, 3, 6 and 12 months later)
B: 6-months prolonged smoking abstinence at age 19 and at age 25 (6 months)
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: Abstinence from smoking in the past 30 days at 6 months and 1 year

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Multiple-Dose Pharmacokinetics, Safety and Tolerability of Varenicline in Healthy Adolescent Smokers
Brief Summary: This study will investigate the multiple dose pharmacokinetics, safety, and tolerability of two dose strengths of varenicline in adolescents aged 12 to 16 years who regularly smoke at least three cigarettes per day.


Options:
A: To compare 12 weeks of treatment with varenicline 1 mg BID to placebo for smoking cessation, and to evaluate continuous abstinence from smoking for 12 weeks after the treatment period.
B: Number of Subjects With Four Week Continuous Quit Rate (CQR) (Week 9 through Week 12)
C: 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)
D: 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).

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Multiple-Dose Pharmacokinetics, Safety and Tolerability of Varenicline in Healthy Adolescent Smokers
Brief Summary: This study will investigate the multiple dose pharmacokinetics, safety, and tolerability of two dose strengths of varenicline in adolescents aged 12 to 16 years who regularly smoke at least three cigarettes per day.


Options:
A: Smoking Abstinence (12 months)
B: 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).
C: 7 Day Point Prevalence of Cigarette Abstinence (6-month follow up); 7 Day Point Prevalence of Cigarette Abstinence (Week 8)
D: Rating of Urges to Smoke 24 Hours and One Week After the Target Quit Date Assessed by Mood and Physical Symptoms Scale (24 hours and 7 days after quit date (week 4))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Multiple-Dose Pharmacokinetics, Safety and Tolerability of Varenicline in Healthy Adolescent Smokers
Brief Summary: This study will investigate the multiple dose pharmacokinetics, safety, and tolerability of two dose strengths of varenicline in adolescents aged 12 to 16 years who regularly smoke at least three cigarettes per day.


Options:
A: efficacy of varied smoking cessation interventions (1 year)
B: seven-day point prevalence of smoking reduction, defined as 50 % reduction in serum cotinine levels compared to baseline (end of treatment)
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: Point prevalence tobacco abstinence at 3 and 6 months

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Multiple-Dose Pharmacokinetics, Safety and Tolerability of Varenicline in Healthy Adolescent Smokers
Brief Summary: This study will investigate the multiple dose pharmacokinetics, safety, and tolerability of two dose strengths of varenicline in adolescents aged 12 to 16 years who regularly smoke at least three cigarettes per day.


Options:
A: 4-week continuous quit rate (CQR) for Weeks 9-12
B: 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)
C: Number of Subjects With a 4 Week Continuous Quit Rate (CQR) From Smokeless Tobacco (Weeks 9 through 12)
D: 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).

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Multicentre Trial of a Brief Intervention (BI) Versus a BI Plus Cognitive Behavioural Treatment (CBT) Versus Nutritional Supplementation for Patients With Long-lasting Back Pain.
Brief Summary: CINS is a large multicentre study which aims to test out the effect of 4 different interventions, namely a brief cognitive intervention (BI), a more extensive cognitive behavioural intervention (CBT), and 2 different nutritional supplementations (seal oil and soy oil) in a population of chronic low back pain patients sicklisted for 2-10 months.


Options:
A: Return-to-work=the proportion of patients who during 1-18 months regained a degree of work ability>0 for at least 30 days in succession. (18 months.)
B: Modified Von Korff Pain Scale for low back pain (baseline 1&2, 6, 12, 18, 24, 39, 52 weeks); Modified Von Korff Disability Scale (baseline 1&2, 6, 12, 18, 24, 39, 52 weeks)
C: Re-operation within 12 months post initial surgery to treat an infection, manage a wound healing problem, or promote fracture healing. (within 12 months)
D: Sickness leave (2008-2020)

Answer: D