TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving the Population-Wide Effectiveness of U.S. Tobacco Cessation Quitlines
Brief Summary: Research shows that smoking cessation is the most significant preventable health behavior change that a person can make to lower cancer risk. In addition, telephone quitlines are an effective, science-based smoking cessation treatment that is universally accessible to smokers in the U.S. However, little research has explored promising approaches that could increase quitline use, improve quit rates, and inform resource allocation for quitline services. The proposed study will test three promising enhancements to the standard quitline treatment that typically consists of counseling and, possibly 2 weeks of a NRT medication. These enhancements are: 1) combination nicotine replacement therapy as recommended by the United States Public Health Service Clinical Practice Guideline on Treating Tobacco Use and Dependence; 2) extended duration of cessation medication use; and 3) an innovative counseling addition - cognitive medication adherence counseling - to optimize adherence to cessation medication. In addition, the cost-effectiveness of each intervention will be calculated. The findings of the proposed research have broad potential application and relevance to state quitlines, quitline service providers, and other purchasers of quitline services such as employers and insurers. Additionally, the study findings can potentially inform other telephone health behavior counseling programs.


Options:
A: 7-day point prevalence by self report (at 6 months)
B: 7-Day Point Prevalence Abstinence From Smoking by Intervention (26 weeks after the target quit smoking date); 7-Day Point Prevalence Abstinence From Smoking by Nicotine Replacement Therapy (NRT) Group (26 weeks after the target quit smoking date)
C: 7-day Point Prevalence Abstinence From Cigarettes (24 months)
D: 30 days prolonged abstinence (6-months postpartum)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving the Population-Wide Effectiveness of U.S. Tobacco Cessation Quitlines
Brief Summary: Research shows that smoking cessation is the most significant preventable health behavior change that a person can make to lower cancer risk. In addition, telephone quitlines are an effective, science-based smoking cessation treatment that is universally accessible to smokers in the U.S. However, little research has explored promising approaches that could increase quitline use, improve quit rates, and inform resource allocation for quitline services. The proposed study will test three promising enhancements to the standard quitline treatment that typically consists of counseling and, possibly 2 weeks of a NRT medication. These enhancements are: 1) combination nicotine replacement therapy as recommended by the United States Public Health Service Clinical Practice Guideline on Treating Tobacco Use and Dependence; 2) extended duration of cessation medication use; and 3) an innovative counseling addition - cognitive medication adherence counseling - to optimize adherence to cessation medication. In addition, the cost-effectiveness of each intervention will be calculated. The findings of the proposed research have broad potential application and relevance to state quitlines, quitline service providers, and other purchasers of quitline services such as employers and insurers. Additionally, the study findings can potentially inform other telephone health behavior counseling programs.


Options:
A: 6 Month Smoking Abstinence (6 months after smoking quit date); 12 Month Smoking Abstinence (12 months after smoking quit date)
B: 7-Day Point Prevalence Abstinence From Smoking by Intervention (26 weeks after the target quit smoking date); 7-Day Point Prevalence Abstinence From Smoking by Nicotine Replacement Therapy (NRT) Group (26 weeks after the target quit smoking date)
C: Biochemically-confirmed 7-Day Point-Prevalence Abstinence at 26 Weeks (Assessed 26 weeks after the target quit day.)
D: Biochemically Verified 7-day Point Prevalence Abstinence (End of Treatment (week 24))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving the Population-Wide Effectiveness of U.S. Tobacco Cessation Quitlines
Brief Summary: Research shows that smoking cessation is the most significant preventable health behavior change that a person can make to lower cancer risk. In addition, telephone quitlines are an effective, science-based smoking cessation treatment that is universally accessible to smokers in the U.S. However, little research has explored promising approaches that could increase quitline use, improve quit rates, and inform resource allocation for quitline services. The proposed study will test three promising enhancements to the standard quitline treatment that typically consists of counseling and, possibly 2 weeks of a NRT medication. These enhancements are: 1) combination nicotine replacement therapy as recommended by the United States Public Health Service Clinical Practice Guideline on Treating Tobacco Use and Dependence; 2) extended duration of cessation medication use; and 3) an innovative counseling addition - cognitive medication adherence counseling - to optimize adherence to cessation medication. In addition, the cost-effectiveness of each intervention will be calculated. The findings of the proposed research have broad potential application and relevance to state quitlines, quitline service providers, and other purchasers of quitline services such as employers and insurers. Additionally, the study findings can potentially inform other telephone health behavior counseling programs.


Options:
A: Point prevalence of smoking cessation (those who have quitted smoking and have not smoked in the past week prior to the assessment date). (52 weeks after starting the treatment)
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: 4-week continuous quit rate (CQR) for Weeks 9-12
D: 7-Day Point Prevalence Abstinence From Smoking by Intervention (26 weeks after the target quit smoking date); 7-Day Point Prevalence Abstinence From Smoking by Nicotine Replacement Therapy (NRT) Group (26 weeks after the target quit smoking date)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Local Anesthetic Use at Iliac Crest Bone Graft Site in Spinal Reconstructive Surgery
Brief Summary: The use of iliac crest bone graft (ICBG) remains the gold-standard in spinal reconstructive surgery for achieving fusion. Major complications from the harvesting of ICBG are rare, but chronic pain has been reported in 10-39%. Catheters implanted at the time of surgery have been used to provide local anesthetic at the harvest site for 24-48 hours after surgery. This has been shown to decrease chronic pain at 4 years post-operatively. A single application of local anesthetic at surgery has been shown to decrease pain at the harvest site for up to 5 days. No study has demonstrated a benefit to using a single application of local anesthetic at the ICBG site beyond 5 days. In current clinical practice, the use of a local anesthetic at the ICBG site is determined according to surgeon preference. The purpose of this study is to determine if a single application of bupivacaine at the ICBG site, as currently done in some cases, provides any pain relief beyond 5 days such as that demonstrated with longer infusions of local anesthetics.


Options:
A: occurrence of chronic pain (3 months)
B: Evaluation of chronic postsurgical pain. (After 3 and 12 months of surgery.)
C: Pain, Cumulative Visual Analog Score, 1st Follow Up (about 4 to 5 weeks after surgery); Pain, Cumulative Visual Analog Score, Final Follow up (about 18 to 20 weeks after surgery)
D: VAS and McGill PRI(R)2 scores for phantom and stump pain are recorded 48 and 24 hours before, and 4 and 10 days, 1 and 6 months after amputation. Phantom and stump pain intensity are the endpoints of the study. (six months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of the Innovative Neurotronics WalkAide Compared to Conventional Ankle-Foot Orthosis (AFO) in Stroke Patients (INSTRIDE)
Brief Summary: To establish equivalence or incremental benefit to standard of care Ankle-Foot Orthosis (AFO) for patients with foot drop due to stroke, and to assess the functional improvement of ambulation and improved activities of daily living.


Options:
A: Change in Action Research Arm Test (ARAT) Score (Baseline and 12 weeks)
B: Gait Velocity (6 months); Stroke Impact Scale (SIS) Composite Score (6 months); Device Related Serious Adverse Events (6 months)
C: Ten Meter Walk Test (10mWT) (Week 30)
D: Fugl-Meyer Motor Assessment (FMA) (Weeks 0, 12, 24, 36)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Levonorgestrel-Intrauterine System (LNG-IUS) Insertion in the Postpartum Period: A Prospective, Randomized Pilot Study of Three Time Intervals
Brief Summary: The investigators study is a prospective randomized trial of women undergoing the levonorgestrel intrauterine system (LNG-IUS: Mirena©, Bayer) at three separate time periods: immediate post placental (IPP) defined as insertion within 10 min delivery of placenta, early post partum (EP) defined as insertion after 10 min but within 72hrs postpartum, or interval (INT) insertion defined as insertion after 6wks postpartum. This is a pilot study in preparation for a multicenter, prospective randomized study of long-acting reversible contraception in the postpartum period.


Options:
A: IUD Use (6 months postpartum)
B: Continuation Rates of the LNG-IUS when placed postpartum at three time periods (at 6 months)
C: Use of the LNG-IUS for Contraception (12 months after cesarean delivery)
D: Implant utilization as measured by the proportion of women using LNG contraceptive implants at 6 months after delivery in women randomized to insertion within 5 days of delivery (immediate insertion) or 6-8 weeks after delivery (delayed insertion). (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Levonorgestrel-Intrauterine System (LNG-IUS) Insertion in the Postpartum Period: A Prospective, Randomized Pilot Study of Three Time Intervals
Brief Summary: The investigators study is a prospective randomized trial of women undergoing the levonorgestrel intrauterine system (LNG-IUS: Mirena©, Bayer) at three separate time periods: immediate post placental (IPP) defined as insertion within 10 min delivery of placenta, early post partum (EP) defined as insertion after 10 min but within 72hrs postpartum, or interval (INT) insertion defined as insertion after 6wks postpartum. This is a pilot study in preparation for a multicenter, prospective randomized study of long-acting reversible contraception in the postpartum period.


Options:
A: IUD Usage Rate at 6 Months (6 months after delivery)
B: Time (6 months)
C: 6 month IUD usage rates (6 months)
D: Continuation Rates of the LNG-IUS when placed postpartum at three time periods (at 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter Randomized Phase II Clinical Trial of Laparoscopy Assisted Versus Open Distal Gastrectomy With D2 Lymph Node Dissection for Advanced Gastric Cancer
Brief Summary: The purpose of this study is to evaluate the oncological feasibility of laparoscopy-assisted distal gastrectomy with D2 lymph node dissection for advanced gastric cancer.


Options:
A: 5 year disease free survival (1week, 1 month, 3 months, 6 months,1 year, 2 years, 3 years,4 years, & 5 years)
B: Post-operative hospital stay (During admission, an expected average of 2 weeks)
C: overall survival
D: noncompliance rate (postoperative 1 week)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Interplay of Social, Normative, and Legal Marijuana Environments and Marijuana and ATOD Use From Late Childhood to Young Adulthood
Brief Summary: The Community Youth Development Study is an experimental test of the Communities That Care (CTC) prevention planning system. It has been designed to find out if communities that were trained to use the CTC system improved public health by reducing rates of adolescent drug use, delinquency, violence, and risky sexual behavior when compared to communities that did not use this approach. The primary purpose of the current continuation study is to investigate whether CTC has long-term effects on substance use, antisocial behavior, and violence, as well as secondary effects on educational attainment, mental health, and sexual risk behavior in young adults at ages 26 and 28. The continuation study also examines (a) how the interaction of social, normative, and legal marijuana contexts creates variation in the permissiveness of individuals' marijuana environments from late childhood to young adulthood and (b) whether, when, and for whom permissive marijuana environments increase marijuana and ATOD use and misuse from age 11 to 28 and interfere with the adoption of adult roles.


Options:
A: 7-day Point Prevalence Smoking Abstinence at 8 Weeks (8 weeks); 7-day Point Prevalence Smoking Abstinence at 16 Weeks (16 Weeks); 7-day Point Prevalence Smoking Abstinence at 26 Weeks (26 Weeks)
B: child urine cotinine (baseline to 16 weeks)
C: Targeted risk and protective factors, substance use, delinquency, violence (Baseline through thirteen-year follow-up (age 23)); CTC coalition functioning, prevention system transformation, evidence-based program (EBP) implementation (Baseline through eight-year follow-up (age 18))
D: Increase in parental competence at nine intervals over 39 month study period (birth-3 year postpartum)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Interplay of Social, Normative, and Legal Marijuana Environments and Marijuana and ATOD Use From Late Childhood to Young Adulthood
Brief Summary: The Community Youth Development Study is an experimental test of the Communities That Care (CTC) prevention planning system. It has been designed to find out if communities that were trained to use the CTC system improved public health by reducing rates of adolescent drug use, delinquency, violence, and risky sexual behavior when compared to communities that did not use this approach. The primary purpose of the current continuation study is to investigate whether CTC has long-term effects on substance use, antisocial behavior, and violence, as well as secondary effects on educational attainment, mental health, and sexual risk behavior in young adults at ages 26 and 28. The continuation study also examines (a) how the interaction of social, normative, and legal marijuana contexts creates variation in the permissiveness of individuals' marijuana environments from late childhood to young adulthood and (b) whether, when, and for whom permissive marijuana environments increase marijuana and ATOD use and misuse from age 11 to 28 and interfere with the adoption of adult roles.


Options:
A: Diagnosis of mental health disorder (15 year follow-up)
B: Self-reported drunkenness (12 months); Self-reported drunkenness (30 months)
C: Targeted risk and protective factors, substance use, delinquency, violence (Baseline through thirteen-year follow-up (age 23)); CTC coalition functioning, prevention system transformation, evidence-based program (EBP) implementation (Baseline through eight-year follow-up (age 18))
D: Drug use frequency and quantity at 1-, 3- and 12-months post-intervention. (1 year post treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Interplay of Social, Normative, and Legal Marijuana Environments and Marijuana and ATOD Use From Late Childhood to Young Adulthood
Brief Summary: The Community Youth Development Study is an experimental test of the Communities That Care (CTC) prevention planning system. It has been designed to find out if communities that were trained to use the CTC system improved public health by reducing rates of adolescent drug use, delinquency, violence, and risky sexual behavior when compared to communities that did not use this approach. The primary purpose of the current continuation study is to investigate whether CTC has long-term effects on substance use, antisocial behavior, and violence, as well as secondary effects on educational attainment, mental health, and sexual risk behavior in young adults at ages 26 and 28. The continuation study also examines (a) how the interaction of social, normative, and legal marijuana contexts creates variation in the permissiveness of individuals' marijuana environments from late childhood to young adulthood and (b) whether, when, and for whom permissive marijuana environments increase marijuana and ATOD use and misuse from age 11 to 28 and interfere with the adoption of adult roles.


Options:
A: Fruit and vegetable intake (Up to one year)
B: the number and spacing of subsequent pregnancies and births (When first child is 12); the rates of marriage and cohabitation with the father of the child (When first child is 12); mothers' employment, career growth, economic self-sufficiency, and welfare dependence (When first child is 12); mothers' behavioral problems due to substance abuse (When first child is 12); children's academic achievement, placements in special education, rates of grade retention, conduct in school, and academic achievement (At age 12); rates of developmental disability, grade retention, placement in special education, and school disciplinary actions among subsequent children (At age 12); mothers' arrests for serious misdemeanors and felonies (When first child is 12)
C: Targeted risk and protective factors, substance use, delinquency, violence (Baseline through thirteen-year follow-up (age 23)); CTC coalition functioning, prevention system transformation, evidence-based program (EBP) implementation (Baseline through eight-year follow-up (age 18))
D: rates of pregnancy and out-of-wedlock child birth (At age 19); educational achievement, including graduation from high school and participation in various types of post-high school education (At age 19); participation in the work force, including enrollment in the armed services (At age 19); use of welfare (At age 19); use of substances (cigarettes, alcohol, and illegal drugs) (At age 19); involvement with the criminal justice system (arrests, convictions, incarcerations, etc.) (At age 19)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Interplay of Social, Normative, and Legal Marijuana Environments and Marijuana and ATOD Use From Late Childhood to Young Adulthood
Brief Summary: The Community Youth Development Study is an experimental test of the Communities That Care (CTC) prevention planning system. It has been designed to find out if communities that were trained to use the CTC system improved public health by reducing rates of adolescent drug use, delinquency, violence, and risky sexual behavior when compared to communities that did not use this approach. The primary purpose of the current continuation study is to investigate whether CTC has long-term effects on substance use, antisocial behavior, and violence, as well as secondary effects on educational attainment, mental health, and sexual risk behavior in young adults at ages 26 and 28. The continuation study also examines (a) how the interaction of social, normative, and legal marijuana contexts creates variation in the permissiveness of individuals' marijuana environments from late childhood to young adulthood and (b) whether, when, and for whom permissive marijuana environments increase marijuana and ATOD use and misuse from age 11 to 28 and interfere with the adoption of adult roles.


Options:
A: Weight loss. (1 year); HgbA1c (1 year)
B: Targeted risk and protective factors, substance use, delinquency, violence (Baseline through thirteen-year follow-up (age 23)); CTC coalition functioning, prevention system transformation, evidence-based program (EBP) implementation (Baseline through eight-year follow-up (age 18))
C: Blood Pressure (6 months post enrollment into trial); LDL Cholesterol (6 months post enrollment into trial); Use of Anti-thrombotic Medication (6 months post enrollment into trial)
D: Reach (RE-AIM Framework) (up to 12 months); Effectiveness (RE-AIM Framework) (up to 24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Acute Effect of Continuous Positive Airway Pressure on Left Ventricular Diastolic Function and Exercise Tolerance in Compensated Heart Failure
Brief Summary: Acute effects of CPAP on diastolic function in patients with compensated heart failure (CHF) are unknown. The investigators hypothesized that acutely CPAP improves diastolic function, which is associated with increases exercise tolerance.

Objective: To evaluate the acute effects of CPAP on functional capacity and diastolic indices of patients with CHF. This is a randomized trial including 44 patients with compensated heart failure (functional classes II or III, NYHA). Patients will be allocated in CPAP(CPAP with 10cmH2O) or simulated CPAP (null pressure) after computed randomization, in a 1:1 ratio. All subjects shall complete a 6-minute walk test (6MWT) before and after CPAP (30 minutes; 10 cm H2O pressure). Doppler-echocardiogram will be performed before and at the end of CPAP. Wilcoxon or paired t tests were used to compare results, with significance level at p \< 0.05.


Options:
A: Global Rank Endpoint (Baseline, 6 months)
B: Left ventricular ejection fraction confirmed by echocardiography (three months)
C: All Cause Mortality or Unplanned Hospitalisation/Prolongation of Hospitalisation for Worsening Heart Failure (time to first event, assessed for up to 70 weeks); Cardiovascular Mortality or Unplanned Hospitalisation/Prolongation of Hospitalisation for Worsening Heart Failure (time to first event, assessed for up to 70 weeks); All Cause Mortality or All Cause Unplanned Hospitalisation/Prolongation of Hospitalisation (time to first event, assessed for up to 70 weeks)
D: improvement of isovolumetric relaxation time (30 minutes)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label, Exploratory Study to Establish the Safety and Efficacy of 3 Months Treatment With Canakinumab in Patients With Colchicine Resistant Familial Mediterranean Fever
Brief Summary: Establish the safety and efficacy of 3 months treatment with canakinumab in patients with colchicine resistant Familial Mediterranean Fever.


Options:
A: To Assess the Efficacy of Rilonacept in Decreasing the Number of Acute FMF Attacks. (attacks were assessed at the end of each 3 month treatment course (overall up to 6 month of rilonacept and 6 months of placebo, each)); To Determine if There is a Medically Important Difference Between the Safety Profiles of Rilonacept vs. Placebo. (12 months of entire study length)
B: Mor severity scoring system (At baseline and every 12 weeks, up to 24 weeks. Change in disease severity as assessed by the Mor severity scoring system.); Adverse events (up to 24 weeks)
C: To measure the effect of canakinumab on the frequency of FMF attacks defined as percentage of patients with at least 50% reduction in the attack frequency during 3 month treatment period. (12 weeks)
D: Change From Baseline to Week-6 (Part A) Endpoint in Mean Key Symptom Score (KSS) (Baseline (Days -21 to -1) and Week 6 (Days 21-42)); Mean Change in Key Symptom Score (KSS) From Week 15 to Week 24 (During the Randomized Withdrawal Phase or Part B) (Week 15 through Week 24 (randomized withdrawal))

Answer: C