TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-centre, Randomised, Double-blind Study to Compare the Efficacy and Safety of Chlorproguanil-dapsone-artesunate Versus Chlorproguanil-dapsone in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Children, Adolescents and Adults in Africa.
Brief Summary: CDA is a combination of chlorproguanil, dapsone and artesunate, being developed in a public-private partnership with the Medicines for Malaria Venture (MMV), World Health Organisation (WHO-TDR) and academic partners from the London School of Hygiene and Tropical Medicine, University of Liverpool and the Liverpool School of Tropical Medicine as a treatment for acute uncomplicated P. falciparum malaria.

The combination of chlorproguanil HCl (CPG) and dapsone (DDS) as chlorproguanil-dapsone has already been shown to be efficacious against P.falciparum in adults and children in Sub-Sahara Africa. The addition of artesunate to LAPDAP has been demonstrated to increase the parasite kill rate as demonstrated in the phase II study, and reduce the chance of any parasites escaping treatment over the 3-day course. The addition of artesunate is also anticipated to have the population benefit of protection against the development of resistant strains of P.falciparum, although it will not be possible to demonstrate this in a clinical trial. One further population benefit of the artemisinin drugs are their ability to suppress the sexual forms of the parasite (gametocytes), which should reduce infectivity after antimalarial treatment and potentially lower transmission rates with widespread use, including the spread of any parasites resistant to the partner drug.

The aims of this phase III study are to compare the efficacy of a fixed ratio combination tablet of CDA to chlorproguanil-dapsone, and collect supporting safety data. This will be a multi-centre, double-blind, double-dummy, randomised trial, in children, adolescents and adults, with chlorproguanil-dapsone as a comparator.


Options:
A: Mean number of days to gametocyte clearance (gametocyte clearance time, GCT) (14 days); Mean (+/- SD) maximal fall in Hb (g/dL) from enrollment to day 28 of follow-up (28 days)
B: Parasitological cure rate, PCR-corrected, at day 28, in the per-protocol population. Parasitological cure rate is defined as the clearance of the initial malaria infection by day 7 and remaining free of this infection to the day of assessment.
C: Prevalence of P. falciparum gametocyte carriers (QT-NASBA) (Day 7)
D: Gametocyte carriage (14 days during follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-centre, Randomised, Double-blind Study to Compare the Efficacy and Safety of Chlorproguanil-dapsone-artesunate Versus Chlorproguanil-dapsone in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Children, Adolescents and Adults in Africa.
Brief Summary: CDA is a combination of chlorproguanil, dapsone and artesunate, being developed in a public-private partnership with the Medicines for Malaria Venture (MMV), World Health Organisation (WHO-TDR) and academic partners from the London School of Hygiene and Tropical Medicine, University of Liverpool and the Liverpool School of Tropical Medicine as a treatment for acute uncomplicated P. falciparum malaria.

The combination of chlorproguanil HCl (CPG) and dapsone (DDS) as chlorproguanil-dapsone has already been shown to be efficacious against P.falciparum in adults and children in Sub-Sahara Africa. The addition of artesunate to LAPDAP has been demonstrated to increase the parasite kill rate as demonstrated in the phase II study, and reduce the chance of any parasites escaping treatment over the 3-day course. The addition of artesunate is also anticipated to have the population benefit of protection against the development of resistant strains of P.falciparum, although it will not be possible to demonstrate this in a clinical trial. One further population benefit of the artemisinin drugs are their ability to suppress the sexual forms of the parasite (gametocytes), which should reduce infectivity after antimalarial treatment and potentially lower transmission rates with widespread use, including the spread of any parasites resistant to the partner drug.

The aims of this phase III study are to compare the efficacy of a fixed ratio combination tablet of CDA to chlorproguanil-dapsone, and collect supporting safety data. This will be a multi-centre, double-blind, double-dummy, randomised trial, in children, adolescents and adults, with chlorproguanil-dapsone as a comparator.


Options:
A: Parasitological outcome after 28 days follow-up (28 days)
B: Development of sexual stages of P.falciparum (42 days post treatment)
C: P.falciparum parasitaemia detected by PCR on days 3,7 and 14. (14 days from start of treatment)
D: Parasitological cure rate, PCR-corrected, at day 28, in the per-protocol population. Parasitological cure rate is defined as the clearance of the initial malaria infection by day 7 and remaining free of this infection to the day of assessment.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-centre, Randomised, Double-blind Study to Compare the Efficacy and Safety of Chlorproguanil-dapsone-artesunate Versus Chlorproguanil-dapsone in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Children, Adolescents and Adults in Africa.
Brief Summary: CDA is a combination of chlorproguanil, dapsone and artesunate, being developed in a public-private partnership with the Medicines for Malaria Venture (MMV), World Health Organisation (WHO-TDR) and academic partners from the London School of Hygiene and Tropical Medicine, University of Liverpool and the Liverpool School of Tropical Medicine as a treatment for acute uncomplicated P. falciparum malaria.

The combination of chlorproguanil HCl (CPG) and dapsone (DDS) as chlorproguanil-dapsone has already been shown to be efficacious against P.falciparum in adults and children in Sub-Sahara Africa. The addition of artesunate to LAPDAP has been demonstrated to increase the parasite kill rate as demonstrated in the phase II study, and reduce the chance of any parasites escaping treatment over the 3-day course. The addition of artesunate is also anticipated to have the population benefit of protection against the development of resistant strains of P.falciparum, although it will not be possible to demonstrate this in a clinical trial. One further population benefit of the artemisinin drugs are their ability to suppress the sexual forms of the parasite (gametocytes), which should reduce infectivity after antimalarial treatment and potentially lower transmission rates with widespread use, including the spread of any parasites resistant to the partner drug.

The aims of this phase III study are to compare the efficacy of a fixed ratio combination tablet of CDA to chlorproguanil-dapsone, and collect supporting safety data. This will be a multi-centre, double-blind, double-dummy, randomised trial, in children, adolescents and adults, with chlorproguanil-dapsone as a comparator.


Options:
A: Cure rate (63 days)
B: Parasitological cure rate, PCR-corrected, at day 28, in the per-protocol population. Parasitological cure rate is defined as the clearance of the initial malaria infection by day 7 and remaining free of this infection to the day of assessment.
C: Mean number of days to gametocyte clearance (gametocyte clearance time, GCT) (14 days); Mean (+/- SD) maximal fall in Hb (g/dL) from enrollment to day 28 of follow-up (28 days)
D: P.falciparum parasitaemia detected by PCR on days 3,7 and 14. (14 days from start of treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Multinational Study Of Efficacy And Safety Of Varenicline Tartrate For Smoking Cessation
Brief Summary: To investigate safety and efficacy of varenicline tartrate in helping people quit smoking


Options:
A: To demonstrate an increase in smoking abstinence rate (12 months)
B: 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)
C: Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. (Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).)
D: 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.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Multinational Study Of Efficacy And Safety Of Varenicline Tartrate For Smoking Cessation
Brief Summary: To investigate safety and efficacy of varenicline tartrate in helping people quit smoking


Options:
A: smoking cessation (52 weeks)
B: The primary outcome will be the biochemically confirmed (exhaled CO < 10 ppm) self-reported continuous abstinence for weeks 12 to 26. (26 weeks)
C: 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.
D: Safety (Baseline (week 0), Weeks 1-9, End of trial (Week 10)); Smoking cessation (End of trial (Week 10))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Multinational Study Of Efficacy And Safety Of Varenicline Tartrate For Smoking Cessation
Brief Summary: To investigate safety and efficacy of varenicline tartrate in helping people quit smoking


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: 7-day point prevalence abstinence measured at 6 months (6 months)
C: 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))
D: 7-day Point Prevalence Smoking Abstinence at End of Treatment (Week 8) (8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Multinational Study Of Efficacy And Safety Of Varenicline Tartrate For Smoking Cessation
Brief Summary: To investigate safety and efficacy of varenicline tartrate in helping people quit smoking


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: Change in Carbon Monoxide Level (Baseline, 2 week, 4 week, 6 week, 8 week, 13 week, 26 week); Change in Cancer Related Toxin, 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol or NNAL (Baseline, 4 week, 8 week, 13 week, 26 week); Change in the use of e-cigarettes (Baseline, 2 week, 4 week, 6 week, 8 week, 13 week, 26 week)
C: Traditional smoking cessation rate (5 years); Change from baseline in the number of traditional cigarette smoked (6, 12, 24, 36 and 60 months.)
D: The primary outcome will be the biochemically confirmed (exhaled CO < 10 ppm) self-reported continuous abstinence for weeks 12 to 26. (26 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Multinational Study Of Efficacy And Safety Of Varenicline Tartrate For Smoking Cessation
Brief Summary: To investigate safety and efficacy of varenicline tartrate in helping people quit smoking


Options:
A: Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period
B: Comparison of Prolonged Abstinence (up to12 weeks post-quit)
C: Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking (Week 15 - 24)
D: 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.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Multinational Study Of Efficacy And Safety Of Varenicline Tartrate For Smoking Cessation
Brief Summary: To investigate safety and efficacy of varenicline tartrate in helping people quit smoking


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: continuous abstinence (CAR) from weeks 9 to 12 of treatment (3 months)
C: 4-week continuous quit rate (CQR) for Weeks 9-12
D: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Multinational Study Of Efficacy And Safety Of Varenicline Tartrate For Smoking Cessation
Brief Summary: To investigate safety and efficacy of varenicline tartrate in helping people quit smoking


Options:
A: 7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed (6 months post quit date)
B: seven-day point prevalence of smoking reduction, defined as 50 % reduction in serum cotinine levels compared to baseline (end of treatment)
C: Primary result is percent not using NRT and not smoking at 12 weeks (point prevalence last 7 days) verified by self-declaration combined with a CO < 8 ppm and a p-cotinine < 15 ng/ml (12 weeks +/- 1 week)
D: 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.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Multinational Study Of Efficacy And Safety Of Varenicline Tartrate For Smoking Cessation
Brief Summary: To investigate safety and efficacy of varenicline tartrate in helping people quit smoking


Options:
A: 7-day Point Prevalence Quit Rate at End-of-Treatment (EOT) (Week 11)
B: Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale (1 week)
C: Primary result is percent not using NRT and not smoking at 12 weeks (point prevalence last 7 days) verified by self-declaration combined with a CO < 8 ppm and a p-cotinine < 15 ng/ml (12 weeks +/- 1 week)
D: 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.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Multinational Study Of Efficacy And Safety Of Varenicline Tartrate For Smoking Cessation
Brief Summary: To investigate safety and efficacy of varenicline tartrate in helping people quit smoking


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: 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: The four-week continuous quit rate over the last four weeks of treatment (Last 4 weeks of therapy)
D: The Fagerstrom Test for Nicotine Dependence, expired CO level, and urine cotinine will be used to determine if bupropion SR, when used as an adjunct to antipsychotic medication, is superior to placebo for helping patients with schizophrenia improve their (Expired CO weekly, Fagerstrom baseline and end of study, Urine cotinine baseline, week 2 and week 8); Neuropsychological testing will be used to determine the effects of smoking cessation on patient's attention and memory function. (Beginning and end of study)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Multinational Study Of Efficacy And Safety Of Varenicline Tartrate For Smoking Cessation
Brief Summary: To investigate safety and efficacy of varenicline tartrate in helping people quit smoking


Options:
A: Patient report (Within 3 days of the dental encounter)
B: 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)
C: Number of Participants Reporting Continuous Smoking Abstinence in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions. (Last 4 weeks of treatment); Mean Percentage of Heavy Drinking Days Comparing Participants in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions (First 3 weeks (pretreatment))
D: 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.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Multinational Study Of Efficacy And Safety Of Varenicline Tartrate For Smoking Cessation
Brief Summary: To investigate safety and efficacy of varenicline tartrate in helping people quit smoking


Options:
A: Comparison of Prolonged Abstinence (up to12 weeks post-quit)
B: 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))
C: Continuous abstinence Weeks 13 -24.
D: 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.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Unsafe Drinking in HIV Primary Care
Brief Summary: The main aim of this study is to test an intervention to reduce unsafe drinking among HIV-positive primary care patients. The intervention consists of a brief motivational interview, which is combined with daily alcohol monitoring through the use of an interactive voice response system IVR (automated telephone system). Subjects who receive the enhanced motivational interview are expected to show greater improvements in drinking than individuals who receive the standard motivational interview or view a DVD on HIV self-care.


Options:
A: Alcohol consumption in the last 30 days, assessed at baseline and repeatedly during follow-up so that change can be analyzed. (Baseline, 30, 60 days (end-of-treatment), 3, 6, 12 months)
B: Number of Times Used Alcohol (Past 3 months)
C: Overdose Risk Behavior (6 months post-baseline); Overdose Knowledge (6 months post-baseline); Behavioral Intentions (6 months post-baseline)
D: Discontinuation of consumption of prescription drugs (one year); Reduction of consumption of prescription drugs (one year); Utilization of formal help (one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Unsafe Drinking in HIV Primary Care
Brief Summary: The main aim of this study is to test an intervention to reduce unsafe drinking among HIV-positive primary care patients. The intervention consists of a brief motivational interview, which is combined with daily alcohol monitoring through the use of an interactive voice response system IVR (automated telephone system). Subjects who receive the enhanced motivational interview are expected to show greater improvements in drinking than individuals who receive the standard motivational interview or view a DVD on HIV self-care.


Options:
A: Frequency of consumption (6 months and 12 months); Usual number of drinks per occasion (6 months and 12 months); Frequency of consuming 5 or more drinks on one occasion (6 months and 12 months); Typical weekly consumption (6 months and 12 months); Highest number of drinks on one occasion (6 months and 12 months)
B: Alcohol consumption in the last 30 days, assessed at baseline and repeatedly during follow-up so that change can be analyzed. (Baseline, 30, 60 days (end-of-treatment), 3, 6, 12 months)
C: proportion of negative breath samples submitted (Week 4)
D: Change in estimated Blood Alcohol Concentration (eBAC) (6, 12 and 18 weeks); Alcohol Use Disorders Identification Test (AUDIT) (6, 12 and 18 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Unsafe Drinking in HIV Primary Care
Brief Summary: The main aim of this study is to test an intervention to reduce unsafe drinking among HIV-positive primary care patients. The intervention consists of a brief motivational interview, which is combined with daily alcohol monitoring through the use of an interactive voice response system IVR (automated telephone system). Subjects who receive the enhanced motivational interview are expected to show greater improvements in drinking than individuals who receive the standard motivational interview or view a DVD on HIV self-care.


Options:
A: Alcohol consumption in the last 30 days, assessed at baseline and repeatedly during follow-up so that change can be analyzed. (Baseline, 30, 60 days (end-of-treatment), 3, 6, 12 months)
B: Changes in Diabetes Self-management Behaviors as Measured by Summary of Diabetes Self-Care Activities (SDSCA) Scale (Baseline and 1 year); Changes in Minutes of Moderate Physical Activity (Baseline and 1 year); Changes in Minutes of Vigorous Exercise (Baseline and 1 year)
C: Rate of all-cause hospital readmission or death during the 6-month follow-up period. (6 months)
D: Change from baseline in depression outcome at 6-months (6-months from enrollment)

Answer: A