TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicentre, Randomized, Parallel-group, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis
Brief Summary: This randomized, parallel group, double-blind, placebo controlled study will evaluate the efficacy and safety of ocrelizumab in participants with primary progressive multiple sclerosis. Eligible participants will be randomized 2 : 1 to receive either ocrelizumab or placebo.


Options:
A: Montgomery-Asberg Depression Rating Scale (MADRS) (baseline to 3 months)
B: Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 12 Weeks During the Double-Blind Treatment Period (Maximal follow up: 216 weeks for Placebo arm and 217 weeks for Ocrelizumab arm)
C: Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks In Double Blind Period (Week 96)
D: Time to onset of a first UTI within one year of treatment. (one year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicentre, Randomized, Parallel-group, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis
Brief Summary: This randomized, parallel group, double-blind, placebo controlled study will evaluate the efficacy and safety of ocrelizumab in participants with primary progressive multiple sclerosis. Eligible participants will be randomized 2 : 1 to receive either ocrelizumab or placebo.


Options:
A: Relapse Rate: Number of Confirmed Relapses During the Double Blind Study Period (Up to Month 24)
B: Proportion of Participants who are overall disease activity-free at Months 12 and 24 (Baseline and Months 12 and 24); Proportion of participants who are clinical disease activity-free at Months 36 and 48 (Baseline and Months 36 and 48)
C: Time to First Relapse (Baseline up to 96 weeks)
D: Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 12 Weeks During the Double-Blind Treatment Period (Maximal follow up: 216 weeks for Placebo arm and 217 weeks for Ocrelizumab arm)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Smoking Cessation Advice Combined With a Detailed Discussion of the Spirometric Results With the Primary Care Practitioner on the Smoking Habit in Adult Smokers (ESPITAP)
Brief Summary: The purpose of this study is to evaluate the effectiveness of the spirometric results information advice about the smoking habit the investigators designed an intervention trial in primary care.

Hypothesis: In adult smokers, smoking cessation advice combined with a discussion of the spirometric tests on the part of the practitioner achieves a higher rate of tobacco reduction and abandonment than just smoking cessation advice.

Expected results: In adult smokers, a detailed discussion of the results yielded by spirometry tests together with brief smoking cessation advice on the part of the primary care practitioner can facilitate tobacco reduction and abandonment.


Options:
A: Smoking cessation (point prevalence, both self reported as biochemical verified) (12 months)
B: smoking abstinence: self reported abstinence (12 or more months) (12 months)
C: Smoking abstinence: self reported abstinence (12 or more months smoking free. (24 months after last recruitment)
D: Smoking abstinence as measured by 7-day point prevalence abstinence at 12 months following treatment (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Smoking Cessation Advice Combined With a Detailed Discussion of the Spirometric Results With the Primary Care Practitioner on the Smoking Habit in Adult Smokers (ESPITAP)
Brief Summary: The purpose of this study is to evaluate the effectiveness of the spirometric results information advice about the smoking habit the investigators designed an intervention trial in primary care.

Hypothesis: In adult smokers, smoking cessation advice combined with a discussion of the spirometric tests on the part of the practitioner achieves a higher rate of tobacco reduction and abandonment than just smoking cessation advice.

Expected results: In adult smokers, a detailed discussion of the results yielded by spirometry tests together with brief smoking cessation advice on the part of the primary care practitioner can facilitate tobacco reduction and abandonment.


Options:
A: Motivation to quit smoking, utilization of available resources, smoking cessation rate (1 year)
B: Number of subjects versus controls who are non-smokers at 4 weeks and six months after completion of smoking cessation clinic (Nine months (from recruitment to completion))
C: Impact of personalized risk information (baseline); Impact of personalized risk information (3 month)
D: smoking abstinence: self reported abstinence (12 or more months) (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Smoking Cessation Advice Combined With a Detailed Discussion of the Spirometric Results With the Primary Care Practitioner on the Smoking Habit in Adult Smokers (ESPITAP)
Brief Summary: The purpose of this study is to evaluate the effectiveness of the spirometric results information advice about the smoking habit the investigators designed an intervention trial in primary care.

Hypothesis: In adult smokers, smoking cessation advice combined with a discussion of the spirometric tests on the part of the practitioner achieves a higher rate of tobacco reduction and abandonment than just smoking cessation advice.

Expected results: In adult smokers, a detailed discussion of the results yielded by spirometry tests together with brief smoking cessation advice on the part of the primary care practitioner can facilitate tobacco reduction and abandonment.


Options:
A: Smoking abstinence rate (At 12 months); Cost-effectiveness (At 12 months)
B: Self-reported Quit Attempts - The Primary Outcome is the Number of Veteran's Who Make a Self-reported Quit Attempt (as Defined as a 24-hour Point Prevalence Rate). (During 90-session intervention period); Number of Participants Who Progressed Along the Stage of Change Toward Action as Measured by the Transtheoretical Model of Change (Short Form) Questionnaire. This Will Identify Current Stage of Change for Each Subject. (During 90-session intervention period); Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days. (During 90-session intervention period); Self-reported Quit Attempts - The Primary Outcome is the Number of Veteran's Who Make a Self-reported Quit Attempt (as Defined as a 24-hour Point Prevalence Rate). (During the 6-month follow-up period); Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days. (During the 6-month follow-up period); Number of Participants Who Progressed Along the Stage of Change Toward Action as Measured by the Transtheoretical Model of Change (Short Form) Questionnaire. This Will Identify Current Stage of Change for Each Subject. (During the 6-month follow-up period)
C: 7-day point-prevalence abstinence at 2 weeks and 6 month follow-up
D: smoking abstinence: self reported abstinence (12 or more months) (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIb, 24-week, Randomised, Placebo-controlled, Double-blinded, Efficacy and Safety Study of Linagliptin (BI 1356) in Black/African American Patients With Type 2 Diabetes With a MTT Sub-study
Brief Summary: Study of linagliptin vs. placebo in Black/African American patients with T2DM with a MTT sub-study


Options:
A: Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks (baseline, 24 weeks)
B: Rate of loss of creatinine clearance (18 months)
C: Change From Baseline in HbA1c After 24 Weeks (Baseline and 24 weeks)
D: First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. (4.9 years); First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. (4.7 years); First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. (4.7 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label, Multi-center Clinical Trial of Eculizumab in Adult Patients With Atypical Hemolytic-uremic Syndrome
Brief Summary: The record Primary purpose is to assess the efficacy of eculizumab in adult patients with Atypical Hemolytic- Uremic Syndrome (aHUS) to control Thrombotic Microangiopathy (TMA) as characterized by thrombocytopenia, hemolysis and renal impairment.


Options:
A: Percentage Of Complement Inhibitor Treatment-naïve Participants With Complete Thrombotic Microangiopathy (TMA) Response at Week 26 (Week 26)
B: Percentage Of Participants With Complete Thrombotic Microangiopathy (TMA) Response at Week 26 (Week 26)
C: Percentage of Patients With Complete TMA Response (Through 26 weeks); Percentage of Patients With Modified Complete TMA Response (Through 26 weeks)
D: The effect of OMS721 as measured by platelet count change from baseline (26 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Low Intensity Pulmonary Outpatient Rehabilitation in Moderate to Severe COPD
Brief Summary: This randomised-controlled study is undertaken to investigate the effects of a long term low intensity outpatient training program on physical fitness and quality of life in moderate to severe COPD patients.


Options:
A: An increase of the six-minute walking distance by more than 50 m with an improvement in health-related quality-of-life.
B: The two primary outcomes are disease-specific quality of life assessed with the St. George's Respiratory Questionnaire (SGRQ) and the total number of exacerbations
C: Number of hospital admissions for exacerbations of COPD
D: 6-Minute walk distance (Six months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Low Intensity Pulmonary Outpatient Rehabilitation in Moderate to Severe COPD
Brief Summary: This randomised-controlled study is undertaken to investigate the effects of a long term low intensity outpatient training program on physical fitness and quality of life in moderate to severe COPD patients.


Options:
A: Self-management and Activation (6 Months)
B: 6-Minute walk distance (Six months)
C: Change in the distance walked at a 6MWT measured at week 12 (12 weeks)
D: Health related quality of life (12 month follow-up); Incremental cost-effectiveness ratio (ICER) (12 month follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of an Electronic Nicotine Delivery Device (ENDD) on Smoking Cessation and Reduction: a Pilot Study
Brief Summary: The study's major aim is to investigate the ability of a commercial Electronic Nicotine Delivery Device (ENDD) to induce long-term smoking reduction/abstinence in smokers unwilling to quit. Secondary aims are to monitor adverse events and measure participants' perception and acceptance of the product.

This pilot study will evaluate smoking reduction/abstinence effects, product preferences, and adverse events of a currently marketed device in Italy ("Categoria" electronic cigarette - "ORIGINAL" 7.2 mg nicotine cartridges). The primary hypothesis is that the E-Cigarette is a safe device that allows smoking reduction or abstinence in smokers.


Options:
A: Continuous and complete smoking abstinence of the pregnant women from the first administration of nicotine/placebo patch until delivery. (from the first administration of nicotine/placebo patch until delivery)
B: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12
C: Sustained 50% Reduction in the Number of Cig/Day at Week-24 From Baseline (Reducers) (number of cigarettes/day as assessed at week 24)
D: Number of Participants Who Self Report an Average of Zero Cigarettes Smoked Per Day in Preceding 7 Days (32-34 weeks gestation (Visit 6))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of an Electronic Nicotine Delivery Device (ENDD) on Smoking Cessation and Reduction: a Pilot Study
Brief Summary: The study's major aim is to investigate the ability of a commercial Electronic Nicotine Delivery Device (ENDD) to induce long-term smoking reduction/abstinence in smokers unwilling to quit. Secondary aims are to monitor adverse events and measure participants' perception and acceptance of the product.

This pilot study will evaluate smoking reduction/abstinence effects, product preferences, and adverse events of a currently marketed device in Italy ("Categoria" electronic cigarette - "ORIGINAL" 7.2 mg nicotine cartridges). The primary hypothesis is that the E-Cigarette is a safe device that allows smoking reduction or abstinence in smokers.


Options:
A: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
B: Tobacco use (Six-month follow-up)
C: Sustained 50% Reduction in the Number of Cig/Day at Week-24 From Baseline (Reducers) (number of cigarettes/day as assessed at week 24)
D: Number of Participants With 4-week Continuous Abstinence (Weeks 9 through 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of an Electronic Nicotine Delivery Device (ENDD) on Smoking Cessation and Reduction: a Pilot Study
Brief Summary: The study's major aim is to investigate the ability of a commercial Electronic Nicotine Delivery Device (ENDD) to induce long-term smoking reduction/abstinence in smokers unwilling to quit. Secondary aims are to monitor adverse events and measure participants' perception and acceptance of the product.

This pilot study will evaluate smoking reduction/abstinence effects, product preferences, and adverse events of a currently marketed device in Italy ("Categoria" electronic cigarette - "ORIGINAL" 7.2 mg nicotine cartridges). The primary hypothesis is that the E-Cigarette is a safe device that allows smoking reduction or abstinence in smokers.


Options:
A: reducers (week-24 from baseline)
B: Sustained 50% Reduction in the Number of Cig/Day at Week-24 From Baseline (Reducers) (number of cigarettes/day as assessed at week 24)
C: Continuous smoking abstinence rate (Weeks 9 to 12)
D: Change in pulmonary health (dry cough, breath shortness, mouth irritation) index (baseline, 6 months, 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of an Electronic Nicotine Delivery Device (ENDD) on Smoking Cessation and Reduction: a Pilot Study
Brief Summary: The study's major aim is to investigate the ability of a commercial Electronic Nicotine Delivery Device (ENDD) to induce long-term smoking reduction/abstinence in smokers unwilling to quit. Secondary aims are to monitor adverse events and measure participants' perception and acceptance of the product.

This pilot study will evaluate smoking reduction/abstinence effects, product preferences, and adverse events of a currently marketed device in Italy ("Categoria" electronic cigarette - "ORIGINAL" 7.2 mg nicotine cartridges). The primary hypothesis is that the E-Cigarette is a safe device that allows smoking reduction or abstinence in smokers.


Options:
A: continuous abstinence (CAR) from weeks 9 to 12 of treatment (3 months)
B: Sustained 50% Reduction in the Number of Cig/Day at Week-24 From Baseline (Reducers) (number of cigarettes/day as assessed at week 24)
C: Continuous Abstinence Rate (CAR) From Week 9 Through Week 12 (Week 9 through Week 12)
D: reducers (week-24 from baseline)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of an Electronic Nicotine Delivery Device (ENDD) on Smoking Cessation and Reduction: a Pilot Study
Brief Summary: The study's major aim is to investigate the ability of a commercial Electronic Nicotine Delivery Device (ENDD) to induce long-term smoking reduction/abstinence in smokers unwilling to quit. Secondary aims are to monitor adverse events and measure participants' perception and acceptance of the product.

This pilot study will evaluate smoking reduction/abstinence effects, product preferences, and adverse events of a currently marketed device in Italy ("Categoria" electronic cigarette - "ORIGINAL" 7.2 mg nicotine cartridges). The primary hypothesis is that the E-Cigarette is a safe device that allows smoking reduction or abstinence in smokers.


Options:
A: smoking status (baseline, 3, 6, 12, and 18 months follow-up); commitment to abstinence (baseline, 3, 6, 12, and 18 months); quit attempts (3, 6, 12, and 18 months follow-up)
B: Sustained 50% reduction in the number of cigarettes smoked per day at week-12 from baseline (week-12); Sustained smoking abstinence at week-12 (week 12)
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: Sustained 50% Reduction in the Number of Cig/Day at Week-24 From Baseline (Reducers) (number of cigarettes/day as assessed at week 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of an Electronic Nicotine Delivery Device (ENDD) on Smoking Cessation and Reduction: a Pilot Study
Brief Summary: The study's major aim is to investigate the ability of a commercial Electronic Nicotine Delivery Device (ENDD) to induce long-term smoking reduction/abstinence in smokers unwilling to quit. Secondary aims are to monitor adverse events and measure participants' perception and acceptance of the product.

This pilot study will evaluate smoking reduction/abstinence effects, product preferences, and adverse events of a currently marketed device in Italy ("Categoria" electronic cigarette - "ORIGINAL" 7.2 mg nicotine cartridges). The primary hypothesis is that the E-Cigarette is a safe device that allows smoking reduction or abstinence in smokers.


Options:
A: Sustained 50% Reduction in the Number of Cig/Day at Week-24 From Baseline (Reducers) (number of cigarettes/day as assessed at week 24)
B: verified abstinence 6 months (6 months)
C: Number of participants with 7-day point prevalence smoking abstinence (52 weeks)
D: urine carcinogen biomarker of exposure, NNAL (week 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of an Electronic Nicotine Delivery Device (ENDD) on Smoking Cessation and Reduction: a Pilot Study
Brief Summary: The study's major aim is to investigate the ability of a commercial Electronic Nicotine Delivery Device (ENDD) to induce long-term smoking reduction/abstinence in smokers unwilling to quit. Secondary aims are to monitor adverse events and measure participants' perception and acceptance of the product.

This pilot study will evaluate smoking reduction/abstinence effects, product preferences, and adverse events of a currently marketed device in Italy ("Categoria" electronic cigarette - "ORIGINAL" 7.2 mg nicotine cartridges). The primary hypothesis is that the E-Cigarette is a safe device that allows smoking reduction or abstinence in smokers.


Options:
A: Sustained 50% Reduction in the Number of Cig/Day at Week-24 From Baseline (Reducers) (number of cigarettes/day as assessed at week 24)
B: Determine Levels of nicotine effectively delivered by various types and brands of ENDS to the bloodstream and compare them to levels delivered from conventional cigarettes (Up to 1 year); Levels of nicotine effectively delivered by various types and brands of ENDS to the bloodstream and compare them to levels delivered from conventional cigarettes (Up to 1 year); Levels of nicotine effectively delivered by various types and brands of ENDS to the bloodstream and compare them to levels delivered from conventional cigarettes (up to 1 year); Changes in withdrawal symptoms (up to 1 year); Subjective nicotine effect will be analyzed (up to 1 year); Changes in feelings and emotions (up to 1 year)
C: Sustained 50% reduction in the number of cigarettes smoked per day at week-12 from baseline (week-12); Sustained smoking abstinence at week-12 (week 12)
D: Continuous abstinence (Russell Standard) (Six months post quit date)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of an Electronic Nicotine Delivery Device (ENDD) on Smoking Cessation and Reduction: a Pilot Study
Brief Summary: The study's major aim is to investigate the ability of a commercial Electronic Nicotine Delivery Device (ENDD) to induce long-term smoking reduction/abstinence in smokers unwilling to quit. Secondary aims are to monitor adverse events and measure participants' perception and acceptance of the product.

This pilot study will evaluate smoking reduction/abstinence effects, product preferences, and adverse events of a currently marketed device in Italy ("Categoria" electronic cigarette - "ORIGINAL" 7.2 mg nicotine cartridges). The primary hypothesis is that the E-Cigarette is a safe device that allows smoking reduction or abstinence in smokers.


Options:
A: smoking cessation (52 weeks)
B: reducers (week-24 from baseline)
C: urine carcinogen biomarker of exposure, NNAL (week 24)
D: Sustained 50% Reduction in the Number of Cig/Day at Week-24 From Baseline (Reducers) (number of cigarettes/day as assessed at week 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Six Month Randomized Controlled Dietary Intervention Study of the New Nordic Diet vs Average Danish Diet in Adults (18-65y) Using the Shop Model for Optimal Dietary Adherence
Brief Summary: The objective is to investigate whether New Nordic Diet (NND) versus Average Danish Diet (ADD) in adults (18-65 y) with central obesity and components of the metabolic syndrome can improve body weight loss and risk markers of the metabolic syndrome, type 2 diabetes and cardiovascular diseases.


Options:
A: N/A
B: weight change (Change from baseline to 24 months)
C: N/A
D: Change in body weight (kg) (26 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Six Month Randomized Controlled Dietary Intervention Study of the New Nordic Diet vs Average Danish Diet in Adults (18-65y) Using the Shop Model for Optimal Dietary Adherence
Brief Summary: The objective is to investigate whether New Nordic Diet (NND) versus Average Danish Diet (ADD) in adults (18-65 y) with central obesity and components of the metabolic syndrome can improve body weight loss and risk markers of the metabolic syndrome, type 2 diabetes and cardiovascular diseases.


Options:
A: Changes in glucose metabolism, changes in transcriptomic and metabolomic profiles (By 2010)
B: Blood pressure (4 months)
C: Change in body weight (kg) (26 weeks)
D: Combined apparition of hard cardiovascular events (myocardial infarction, revascularization, ischemic stroke, documented peripheral artery disease or cardiovascular death) after a median follow-up of 7 years. (Seven Years)

Answer: C