TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: B-LONG: An Open-Label, Multicenter Evaluation of the Safety, Pharmacokinetics, and Efficacy of Recombinant, Long-acting Coagulation Factor IX Fc Fusion Protein (rFIXFc) in the Prevention and Treatment of Bleeding in Previously Treated Subjects With Severe Hemophilia B
Brief Summary: The primary objectives of the study were: to evaluate the safety and tolerability of rFIXFc; to evaluate the efficacy of rFIXFc in all treatment arms; to evaluate the effectiveness of prophylaxis over on-demand (episodic) therapy by comparing the annualized number of bleeding episodes between participants receiving rFIXFc on each prevention (prophylaxis) regimen and participants receiving rFIXFc on an episodic regimen. The secondary objectives of the study were: to evaluate and assess the pharmacokinetic (PK) parameter estimates of rFIXFc and rFIX (BeneFIX®) at baseline in the Sequential PK subgroup as well as rFIXFc at Week 26 (±1 week); to evaluate participants' response to treatment; to evaluate rFIXFc consumption.


Options:
A: Annualized Bleeding Rate (ABR) (9 months)
B: Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (up to 52 weeks ± 1 week); Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) (up to 52 weeks + 30 days ± 1 week); Number of Participants With Non-serious Treatment-emergent Adverse Events (TEAEs) During the Surgical / Rehabilitation Period (up to 52 weeks + 30 days ± 1 week); Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) During the Surgical / Rehabilitation Period (up to 52 weeks + 30 days ± 1 week); Incidence Rate of FIX Inhibitor Development (up to 52 weeks ± 1 week); Annualized Bleeding Rate (up to 52 weeks ± 1 week (efficacy period as defined in description)); Comparison of Annualized Bleeding Rates (up to 52 weeks ± 1 week (efficacy period as defined in description))
C: To assess the safety of systemic administration of a novel self-complementary AAV vector in adults with severe hemophilia B at up to four different dosage levels. (15 years)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck (VIMS, Danish Acronym)
Brief Summary: Musculoskeletal disorders are frequent among office workers especially in the neck/shoulder area.

The hypothesis is, that specific strength training of the neck/shoulder muscles will alleviate the pain.

The two sub-hypotheses are

1. Alleviation of pain is independent of training frequency
2. Alleviation of pain is higher following supervised training vs training with initial instruction only


Options:
A: Neck Pain (Up to 10 months)
B: pain and disability at 3 and 6 weeks and at 6 months
C: Pain of the neck and shoulders (At week 0 (baseline) and week 20 (follow-up)); Pain in the arm/hand (At week 0 (baseline) and week 20 (follow-up))
D: neck/shoulder pain, selfreported (20 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Simplified Antibiotic Regimens for the Management of Sepsis in Young Infants in First-level Facilities: Randomized Controlled Trial
Brief Summary: This trial evaluates primary care clinic-based simplified antibiotic therapy options for young infants, 0-59 days old in high neonatal mortality settings in peri-urban Karachi where hospital referral is frequently refused by families.


Options:
A: Reduction in perinatal and neonatal mortality (3 years)
B: % of mothers who know at last 3 danger signs (2 years); % of VHSG who know 6 danger signs (2 years); % of families who seek care from an appropriate facility (2 years); Time between onset of suspected danger signs and referral to appropriate facility (2 years); Improved hygiene behavior by family (2 years); Improved infection control behavior among HC staff (2 years)
C: Treatment failure (within 7 days of enrolment)
D: Neurodevelopment as measured by the Protocol for Child Monitoring - Infant and Toddler version assessment (12 months of age)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Simplified Antibiotic Regimens for the Management of Sepsis in Young Infants in First-level Facilities: Randomized Controlled Trial
Brief Summary: This trial evaluates primary care clinic-based simplified antibiotic therapy options for young infants, 0-59 days old in high neonatal mortality settings in peri-urban Karachi where hospital referral is frequently refused by families.


Options:
A: Neonatal mortality rate
B: Treatment failure (Seven days)
C: All cause Neonatal Mortality (2 years)
D: Treatment failure (within 7 days of enrolment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation Treatment for Methadone Maintenance Patients
Brief Summary: Patients in substance abuse treatment smoke four times more than non-substance abusers, and suffer high rates of tobacco-related disease and death. While many quit smoking treatments exist that have been shown to help non-substance abusers quit smoking, little is known about what treatments work for patients in substance abuse treatment. The drug varenicline (Chantix) has been shown to be more effective at helping people quit smoking than nicotine replacement therapy, bupropion or placebo. However, varenicline has not yet been studied in patients in substance abuse treatment. The study aims to evaluate the feasibility, effectiveness and safety of varenicline, in combination with counseling, in methadone maintained smokers. It also aims to evaluate the link between quitting smoking and alcohol and illicit drug use in methadone maintained smokers. We hypothesize that participants receiving varenicline will have higher abstinence from smoking than participants receiving placebo and that participants taking varenicline will not have significantly more adverse reactions than were described in the general population in other studies. We also hypothesize that compared to continued smokers, tobacco abstainers will be more likely to be abstinent from alcohol or illicit drugs.


Options:
A: Number of Participants With Smoking Abstinence at Month 6 (Month 6)
B: Number of Participants With Cotinine-confirmed 7-day Point Prevalence Abstinence at the End of Treatment (7 days at end of treatment); Number of Participants Experiencing Treatment-emergent Adverse Events (26 weeks (12 weeks of treatment plus full post-treatment follow-up))
C: Number of Participants With Continuous Abstinence at End-of-Treatment (EOT) as Assessed by Self-Report and Bio-verification (Self-report Treatment Weeks 12-15; bio-verification ~Week 16)
D: Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. (Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation Treatment for Methadone Maintenance Patients
Brief Summary: Patients in substance abuse treatment smoke four times more than non-substance abusers, and suffer high rates of tobacco-related disease and death. While many quit smoking treatments exist that have been shown to help non-substance abusers quit smoking, little is known about what treatments work for patients in substance abuse treatment. The drug varenicline (Chantix) has been shown to be more effective at helping people quit smoking than nicotine replacement therapy, bupropion or placebo. However, varenicline has not yet been studied in patients in substance abuse treatment. The study aims to evaluate the feasibility, effectiveness and safety of varenicline, in combination with counseling, in methadone maintained smokers. It also aims to evaluate the link between quitting smoking and alcohol and illicit drug use in methadone maintained smokers. We hypothesize that participants receiving varenicline will have higher abstinence from smoking than participants receiving placebo and that participants taking varenicline will not have significantly more adverse reactions than were described in the general population in other studies. We also hypothesize that compared to continued smokers, tobacco abstainers will be more likely to be abstinent from alcohol or illicit drugs.


Options:
A: Traditional smoking cessation rate (5 years); Change from baseline in the number of traditional cigarette smoked (6, 12, 24, 36 and 60 months.)
B: Continuous Abstinence Rate (CAR) From Week 9 Through Week 12 (Week 9 through Week 12)
C: Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. (Week 12)
D: Tobacco use (Six-month follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation Treatment for Methadone Maintenance Patients
Brief Summary: Patients in substance abuse treatment smoke four times more than non-substance abusers, and suffer high rates of tobacco-related disease and death. While many quit smoking treatments exist that have been shown to help non-substance abusers quit smoking, little is known about what treatments work for patients in substance abuse treatment. The drug varenicline (Chantix) has been shown to be more effective at helping people quit smoking than nicotine replacement therapy, bupropion or placebo. However, varenicline has not yet been studied in patients in substance abuse treatment. The study aims to evaluate the feasibility, effectiveness and safety of varenicline, in combination with counseling, in methadone maintained smokers. It also aims to evaluate the link between quitting smoking and alcohol and illicit drug use in methadone maintained smokers. We hypothesize that participants receiving varenicline will have higher abstinence from smoking than participants receiving placebo and that participants taking varenicline will not have significantly more adverse reactions than were described in the general population in other studies. We also hypothesize that compared to continued smokers, tobacco abstainers will be more likely to be abstinent from alcohol or illicit drugs.


Options:
A: Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. (Week 12)
B: Biochemically-confirmed 7-Day Point-Prevalence Abstinence at 26 Weeks (Assessed 26 weeks after the target quit day.)
C: 4 week continuous quit rate ( 4 week CQR ) for weeks 9 -12
D: Proportion of Cocaine Positive Urine Tests Per Week (Weekly Measures over 12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation Treatment for Methadone Maintenance Patients
Brief Summary: Patients in substance abuse treatment smoke four times more than non-substance abusers, and suffer high rates of tobacco-related disease and death. While many quit smoking treatments exist that have been shown to help non-substance abusers quit smoking, little is known about what treatments work for patients in substance abuse treatment. The drug varenicline (Chantix) has been shown to be more effective at helping people quit smoking than nicotine replacement therapy, bupropion or placebo. However, varenicline has not yet been studied in patients in substance abuse treatment. The study aims to evaluate the feasibility, effectiveness and safety of varenicline, in combination with counseling, in methadone maintained smokers. It also aims to evaluate the link between quitting smoking and alcohol and illicit drug use in methadone maintained smokers. We hypothesize that participants receiving varenicline will have higher abstinence from smoking than participants receiving placebo and that participants taking varenicline will not have significantly more adverse reactions than were described in the general population in other studies. We also hypothesize that compared to continued smokers, tobacco abstainers will be more likely to be abstinent from alcohol or illicit drugs.


Options:
A: Days to Relapse (4 weeks)
B: urine carcinogen biomarker of exposure, NNAL (week 24)
C: Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. (Week 12)
D: A significant percentage of surgical patients will be receptive to smoking cessation interventions in the preadmission clinic and will refrain from smoking at 24 and 52 weeks after starting the treatment. (2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation Treatment for Methadone Maintenance Patients
Brief Summary: Patients in substance abuse treatment smoke four times more than non-substance abusers, and suffer high rates of tobacco-related disease and death. While many quit smoking treatments exist that have been shown to help non-substance abusers quit smoking, little is known about what treatments work for patients in substance abuse treatment. The drug varenicline (Chantix) has been shown to be more effective at helping people quit smoking than nicotine replacement therapy, bupropion or placebo. However, varenicline has not yet been studied in patients in substance abuse treatment. The study aims to evaluate the feasibility, effectiveness and safety of varenicline, in combination with counseling, in methadone maintained smokers. It also aims to evaluate the link between quitting smoking and alcohol and illicit drug use in methadone maintained smokers. We hypothesize that participants receiving varenicline will have higher abstinence from smoking than participants receiving placebo and that participants taking varenicline will not have significantly more adverse reactions than were described in the general population in other studies. We also hypothesize that compared to continued smokers, tobacco abstainers will be more likely to be abstinent from alcohol or illicit drugs.


Options:
A: Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. (Week 12)
B: The four-week continuous quit rate over the last four weeks of treatment (Last 4 weeks of therapy)
C: Biochemically Confirmed 7-day Point Prevalence Abstinence From Tobacco (12 weeks following start of medication)
D: 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)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation Treatment for Methadone Maintenance Patients
Brief Summary: Patients in substance abuse treatment smoke four times more than non-substance abusers, and suffer high rates of tobacco-related disease and death. While many quit smoking treatments exist that have been shown to help non-substance abusers quit smoking, little is known about what treatments work for patients in substance abuse treatment. The drug varenicline (Chantix) has been shown to be more effective at helping people quit smoking than nicotine replacement therapy, bupropion or placebo. However, varenicline has not yet been studied in patients in substance abuse treatment. The study aims to evaluate the feasibility, effectiveness and safety of varenicline, in combination with counseling, in methadone maintained smokers. It also aims to evaluate the link between quitting smoking and alcohol and illicit drug use in methadone maintained smokers. We hypothesize that participants receiving varenicline will have higher abstinence from smoking than participants receiving placebo and that participants taking varenicline will not have significantly more adverse reactions than were described in the general population in other studies. We also hypothesize that compared to continued smokers, tobacco abstainers will be more likely to be abstinent from alcohol or illicit drugs.


Options:
A: The primary outcome measure for alcohol use will be the number of drinks/week at the end of the treatment phase, relative to baseline and during-treatment data. (8 weeks)
B: 6 Month Smoking Abstinence (6 months after smoking quit date); 12 Month Smoking Abstinence (12 months after smoking quit date)
C: Smoking Abstinence (12 weeks); Smoking Abstinence (2 weeks)
D: Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. (Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation Treatment for Methadone Maintenance Patients
Brief Summary: Patients in substance abuse treatment smoke four times more than non-substance abusers, and suffer high rates of tobacco-related disease and death. While many quit smoking treatments exist that have been shown to help non-substance abusers quit smoking, little is known about what treatments work for patients in substance abuse treatment. The drug varenicline (Chantix) has been shown to be more effective at helping people quit smoking than nicotine replacement therapy, bupropion or placebo. However, varenicline has not yet been studied in patients in substance abuse treatment. The study aims to evaluate the feasibility, effectiveness and safety of varenicline, in combination with counseling, in methadone maintained smokers. It also aims to evaluate the link between quitting smoking and alcohol and illicit drug use in methadone maintained smokers. We hypothesize that participants receiving varenicline will have higher abstinence from smoking than participants receiving placebo and that participants taking varenicline will not have significantly more adverse reactions than were described in the general population in other studies. We also hypothesize that compared to continued smokers, tobacco abstainers will be more likely to be abstinent from alcohol or illicit drugs.


Options:
A: 7 Day Point Prevalence of Cigarette Abstinence (6-month follow up); 7 Day Point Prevalence of Cigarette Abstinence (Week 8)
B: Smoking behavior (after 5 hrs abstinence)
C: Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. (Week 12)
D: Treatment Satisfaction (End of treatment (seven weeks after baseline))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation Treatment for Methadone Maintenance Patients
Brief Summary: Patients in substance abuse treatment smoke four times more than non-substance abusers, and suffer high rates of tobacco-related disease and death. While many quit smoking treatments exist that have been shown to help non-substance abusers quit smoking, little is known about what treatments work for patients in substance abuse treatment. The drug varenicline (Chantix) has been shown to be more effective at helping people quit smoking than nicotine replacement therapy, bupropion or placebo. However, varenicline has not yet been studied in patients in substance abuse treatment. The study aims to evaluate the feasibility, effectiveness and safety of varenicline, in combination with counseling, in methadone maintained smokers. It also aims to evaluate the link between quitting smoking and alcohol and illicit drug use in methadone maintained smokers. We hypothesize that participants receiving varenicline will have higher abstinence from smoking than participants receiving placebo and that participants taking varenicline will not have significantly more adverse reactions than were described in the general population in other studies. We also hypothesize that compared to continued smokers, tobacco abstainers will be more likely to be abstinent from alcohol or illicit drugs.


Options:
A: Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking (Week 15 - 24)
B: Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. (Week 12)
C: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12
D: Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers. (3 months); Point Prevalence Abstinence at 3 Months. (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation Treatment for Methadone Maintenance Patients
Brief Summary: Patients in substance abuse treatment smoke four times more than non-substance abusers, and suffer high rates of tobacco-related disease and death. While many quit smoking treatments exist that have been shown to help non-substance abusers quit smoking, little is known about what treatments work for patients in substance abuse treatment. The drug varenicline (Chantix) has been shown to be more effective at helping people quit smoking than nicotine replacement therapy, bupropion or placebo. However, varenicline has not yet been studied in patients in substance abuse treatment. The study aims to evaluate the feasibility, effectiveness and safety of varenicline, in combination with counseling, in methadone maintained smokers. It also aims to evaluate the link between quitting smoking and alcohol and illicit drug use in methadone maintained smokers. We hypothesize that participants receiving varenicline will have higher abstinence from smoking than participants receiving placebo and that participants taking varenicline will not have significantly more adverse reactions than were described in the general population in other studies. We also hypothesize that compared to continued smokers, tobacco abstainers will be more likely to be abstinent from alcohol or illicit drugs.


Options:
A: 7-day point-prevalence abstinence rate at 52 weeks after quit date (at 52 weeks after the agreed quit date)
B: Rating of urges to smoke 1-week after the target quit (1 week)
C: Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. (Week 12)
D: 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)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation Treatment for Methadone Maintenance Patients
Brief Summary: Patients in substance abuse treatment smoke four times more than non-substance abusers, and suffer high rates of tobacco-related disease and death. While many quit smoking treatments exist that have been shown to help non-substance abusers quit smoking, little is known about what treatments work for patients in substance abuse treatment. The drug varenicline (Chantix) has been shown to be more effective at helping people quit smoking than nicotine replacement therapy, bupropion or placebo. However, varenicline has not yet been studied in patients in substance abuse treatment. The study aims to evaluate the feasibility, effectiveness and safety of varenicline, in combination with counseling, in methadone maintained smokers. It also aims to evaluate the link between quitting smoking and alcohol and illicit drug use in methadone maintained smokers. We hypothesize that participants receiving varenicline will have higher abstinence from smoking than participants receiving placebo and that participants taking varenicline will not have significantly more adverse reactions than were described in the general population in other studies. We also hypothesize that compared to continued smokers, tobacco abstainers will be more likely to be abstinent from alcohol or illicit drugs.


Options:
A: Number of smokers referred to tobacco cessation website (12 months)
B: 7-day Point Prevalence Abstinence From Smoking at 6 Months (6 months)
C: Biochemically/pharmacologically-confirmed 12-month continuous abstinence as evidenced by self-reports of nonsmoking status in all interviews (i.e., at 3, 6, and 12 months) (12 months)
D: Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. (Week 12)

Answer: D