TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Concurrent Bupropion / Varenicline for Smoking Cessation
Brief Summary: This study focuses on the first step in developing an algorithm for maximizing quit-smoking success based on an adaptive approach, which changes treatment from the initial nicotine replacement therapy (NRT) when that treatment alone may not be sufficient. These NRT "non-responders" are switched (in double-blind fashion) before the quit date to receive either varenicline alone or varenicline paired with bupropion. Some participants who would otherwise have failed at their quit smoking attempt could be "rescued" by switching to alternative pharmacotherapies. The proposed study will evaluate the combination treatment against varenicline alone in an adaptive trial design


Options:
A: 4 week continuous quit rate ( 4 week CQR ) for weeks 9 -12
B: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)
C: To examine the effects of varenicline treatment used concomitantly with antipsychotic medications, on cognitive dysfunction in people with schizophrenia. (8 weeks)
D: Long term abstinence (one year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Concurrent Bupropion / Varenicline for Smoking Cessation
Brief Summary: This study focuses on the first step in developing an algorithm for maximizing quit-smoking success based on an adaptive approach, which changes treatment from the initial nicotine replacement therapy (NRT) when that treatment alone may not be sufficient. These NRT "non-responders" are switched (in double-blind fashion) before the quit date to receive either varenicline alone or varenicline paired with bupropion. Some participants who would otherwise have failed at their quit smoking attempt could be "rescued" by switching to alternative pharmacotherapies. The proposed study will evaluate the combination treatment against varenicline alone in an adaptive trial design


Options:
A: Percent Compliance With Chantix (Months 1, 2, 3)
B: Safety (Baseline (week 0), Weeks 1-9, End of trial (Week 10)); Smoking cessation (End of trial (Week 10))
C: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)
D: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Concurrent Bupropion / Varenicline for Smoking Cessation
Brief Summary: This study focuses on the first step in developing an algorithm for maximizing quit-smoking success based on an adaptive approach, which changes treatment from the initial nicotine replacement therapy (NRT) when that treatment alone may not be sufficient. These NRT "non-responders" are switched (in double-blind fashion) before the quit date to receive either varenicline alone or varenicline paired with bupropion. Some participants who would otherwise have failed at their quit smoking attempt could be "rescued" by switching to alternative pharmacotherapies. The proposed study will evaluate the combination treatment against varenicline alone in an adaptive trial design


Options:
A: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)
B: Will bupropion reduce relapse to smoking compared to placebo (52 weeks and 76 weeks)
C: Number of Participants With Smoking Abstinence at Month 6 (Month 6)
D: Smoking Abstinence (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Concurrent Bupropion / Varenicline for Smoking Cessation
Brief Summary: This study focuses on the first step in developing an algorithm for maximizing quit-smoking success based on an adaptive approach, which changes treatment from the initial nicotine replacement therapy (NRT) when that treatment alone may not be sufficient. These NRT "non-responders" are switched (in double-blind fashion) before the quit date to receive either varenicline alone or varenicline paired with bupropion. Some participants who would otherwise have failed at their quit smoking attempt could be "rescued" by switching to alternative pharmacotherapies. The proposed study will evaluate the combination treatment against varenicline alone in an adaptive trial design


Options:
A: Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt) (weeks 9 through 12)
B: 7-day Prevalence of Abstinence From Cigarette Smoking at 12 Weeks (12 weeks); 7 Day Prevalence of Abstinence From Cigarette Smoking at 24 Weeks (24 weeks)
C: Smoking Behaviour (56 weeks post participant start date)
D: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Concurrent Bupropion / Varenicline for Smoking Cessation
Brief Summary: This study focuses on the first step in developing an algorithm for maximizing quit-smoking success based on an adaptive approach, which changes treatment from the initial nicotine replacement therapy (NRT) when that treatment alone may not be sufficient. These NRT "non-responders" are switched (in double-blind fashion) before the quit date to receive either varenicline alone or varenicline paired with bupropion. Some participants who would otherwise have failed at their quit smoking attempt could be "rescued" by switching to alternative pharmacotherapies. The proposed study will evaluate the combination treatment against varenicline alone in an adaptive trial design


Options:
A: Participants Abstinent From Cigarettes (Two years)
B: Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint (Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.); Estimated NPS AE Rate (%), by Cohort (Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.)
C: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)
D: The primary outcome variable for the study was biochemically verified 7-day point prevalence smoking cessation at 6 months, defined as having smoked no cigarettes - not even a puff - for the previous 7 days. (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Concurrent Bupropion / Varenicline for Smoking Cessation
Brief Summary: This study focuses on the first step in developing an algorithm for maximizing quit-smoking success based on an adaptive approach, which changes treatment from the initial nicotine replacement therapy (NRT) when that treatment alone may not be sufficient. These NRT "non-responders" are switched (in double-blind fashion) before the quit date to receive either varenicline alone or varenicline paired with bupropion. Some participants who would otherwise have failed at their quit smoking attempt could be "rescued" by switching to alternative pharmacotherapies. The proposed study will evaluate the combination treatment against varenicline alone in an adaptive trial design


Options:
A: Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 6 Months (6 months)
B: Smoking behavior (after 5 hrs abstinence)
C: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
D: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Concurrent Bupropion / Varenicline for Smoking Cessation
Brief Summary: This study focuses on the first step in developing an algorithm for maximizing quit-smoking success based on an adaptive approach, which changes treatment from the initial nicotine replacement therapy (NRT) when that treatment alone may not be sufficient. These NRT "non-responders" are switched (in double-blind fashion) before the quit date to receive either varenicline alone or varenicline paired with bupropion. Some participants who would otherwise have failed at their quit smoking attempt could be "rescued" by switching to alternative pharmacotherapies. The proposed study will evaluate the combination treatment against varenicline alone in an adaptive trial design


Options:
A: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)
B: Number of Participants With 4-week Continuous Abstinence (Weeks 9 through 12)
C: Number of Subjects With Four Week Continuous Quit Rate (CQR) (Week 9 through Week 12)
D: Long term abstinence (one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Concurrent Bupropion / Varenicline for Smoking Cessation
Brief Summary: This study focuses on the first step in developing an algorithm for maximizing quit-smoking success based on an adaptive approach, which changes treatment from the initial nicotine replacement therapy (NRT) when that treatment alone may not be sufficient. These NRT "non-responders" are switched (in double-blind fashion) before the quit date to receive either varenicline alone or varenicline paired with bupropion. Some participants who would otherwise have failed at their quit smoking attempt could be "rescued" by switching to alternative pharmacotherapies. The proposed study will evaluate the combination treatment against varenicline alone in an adaptive trial design


Options:
A: Biochemically Verified 7-day Point Prevalence Abstinence (End of Treatment (week 24))
B: 7-day point prevalence abstinence measured at 6 months (6 months)
C: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)
D: 7 Day Point Prevalence of Cigarette Abstinence (6-month follow up); 7 Day Point Prevalence of Cigarette Abstinence (Week 8)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Concurrent Bupropion / Varenicline for Smoking Cessation
Brief Summary: This study focuses on the first step in developing an algorithm for maximizing quit-smoking success based on an adaptive approach, which changes treatment from the initial nicotine replacement therapy (NRT) when that treatment alone may not be sufficient. These NRT "non-responders" are switched (in double-blind fashion) before the quit date to receive either varenicline alone or varenicline paired with bupropion. Some participants who would otherwise have failed at their quit smoking attempt could be "rescued" by switching to alternative pharmacotherapies. The proposed study will evaluate the combination treatment against varenicline alone in an adaptive trial design


Options:
A: Validated smoking cessation (6 months)
B: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)
C: 4 week continuous quit rate ( 4 week CQR ) for weeks 9 -12
D: 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)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Concurrent Bupropion / Varenicline for Smoking Cessation
Brief Summary: This study focuses on the first step in developing an algorithm for maximizing quit-smoking success based on an adaptive approach, which changes treatment from the initial nicotine replacement therapy (NRT) when that treatment alone may not be sufficient. These NRT "non-responders" are switched (in double-blind fashion) before the quit date to receive either varenicline alone or varenicline paired with bupropion. Some participants who would otherwise have failed at their quit smoking attempt could be "rescued" by switching to alternative pharmacotherapies. The proposed study will evaluate the combination treatment against varenicline alone in an adaptive trial design


Options:
A: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)
B: Treatment Satisfaction (End of treatment (seven weeks after baseline))
C: effectiveness (2 years)
D: The primary efficacy outcome is smoking abstinence for any continuous 4-week period (4-week CQR) during the study treatment phase.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-Randomized Multi-Center Study Demonstrating the Efficacy of Terminal Complement Inhibition in Patients With Cold Agglutinin Disease Using Eculizumab
Brief Summary: Evaluation of the efficacy and safety of eculizumab in symptomatic or transfusion-dependent patients with untreated or refractory hemolytic cold agglutinin disease(CAD)


Options:
A: LDH (From baseline to 26 weeks)
B: Frequency of complete and partial responses (CR/PR) (6 months)
C: overall response (month +2)
D: Percentage of Participants Achieving Durable Response of Improvement in Hemoglobin (Hgb) (Up to Week 20 of the double-blind period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Virtual Reality Intervention for Stroke Rehabilitation
Brief Summary: In Israel approximately 16,000 people have a stroke each year. Most of these people suffer from weakness or paralysis of half of their body which leads to difficulties performing basic activities of daily life (BADL) such as dressing and walking. Due to the stroke, these individuals need to undergo intensive rehabilitation. After rehabilitation, physical activity has been strongly recommended to maintain their functional level which was achieved during rehabilitation. In addition regular physical activity can prevent secondary condition However, recent findings suggest that people with stroke do not perform enough physical activity with their upper and lower extremities.

The use of Virtual Reality (VR) for rehabilitation has been found to have potential for encouraging active purposeful movement. Many researchers have assessed the feasibility \& usability of different VR systems and environments for individuals with stroke. Costly VR systems in addition to off-the-shelf video game consoles (e.g. Sony PlayStation EyeToy, Nintendo Wii) have been found to have great potential to encourage active purposeful movement. However, to date, only a limited number of studies have investigated the effectiveness of VR therapy post-stroke.

Since physical activity is important after stroke and the fact that individuals with stroke are not participating sufficiently in physical activity, I suggest to carry out this study.

The overall aim of this study is to assess the effectiveness of using novel technology of VR therapy to promote the participation in daily physical activity of individuals with stroke. A 'Community based' VR program will be compared to a traditional therapy program in promoting daily physical activity of the lower and upper extremities.

It is hypothesized that the VR intervention will be more efficient than the traditional therapy in promoting physical activity (walking and use of the weak upper extremity).


Options:
A: Adherence (8 weeks)
B: Reach (Follow-up (week 16)); Retention (Follow-up (week 16)); Satisfaction with program (Post-intervention (week 9))
C: Difference in physical activity scale for the elderly (24 months)
D: Physical activity of the lower and upper extremities (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Virtual Reality Intervention for Stroke Rehabilitation
Brief Summary: In Israel approximately 16,000 people have a stroke each year. Most of these people suffer from weakness or paralysis of half of their body which leads to difficulties performing basic activities of daily life (BADL) such as dressing and walking. Due to the stroke, these individuals need to undergo intensive rehabilitation. After rehabilitation, physical activity has been strongly recommended to maintain their functional level which was achieved during rehabilitation. In addition regular physical activity can prevent secondary condition However, recent findings suggest that people with stroke do not perform enough physical activity with their upper and lower extremities.

The use of Virtual Reality (VR) for rehabilitation has been found to have potential for encouraging active purposeful movement. Many researchers have assessed the feasibility \& usability of different VR systems and environments for individuals with stroke. Costly VR systems in addition to off-the-shelf video game consoles (e.g. Sony PlayStation EyeToy, Nintendo Wii) have been found to have great potential to encourage active purposeful movement. However, to date, only a limited number of studies have investigated the effectiveness of VR therapy post-stroke.

Since physical activity is important after stroke and the fact that individuals with stroke are not participating sufficiently in physical activity, I suggest to carry out this study.

The overall aim of this study is to assess the effectiveness of using novel technology of VR therapy to promote the participation in daily physical activity of individuals with stroke. A 'Community based' VR program will be compared to a traditional therapy program in promoting daily physical activity of the lower and upper extremities.

It is hypothesized that the VR intervention will be more efficient than the traditional therapy in promoting physical activity (walking and use of the weak upper extremity).


Options:
A: Fugl_Meyer Upper Extremity scale (F-M UE) (20 min)
B: Physical activity of the lower and upper extremities (6 months)
C: Fugl-meyer assessment_upper extremity (Change from baseline in Fugl-Meyer assessment at 4 weeks after intervention)
D: Length of outpatient rehab stay (LOS) (From admission to discharge, an expected average of 5 weeks.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Intranasal (IN) Ketamine in Treatment-Resistant Depression (TRD)
Brief Summary: The objective of the current study is to investigate the safety and efficacy of a single dose of intranasal (IN) ketamine in treatment-resistant depression (TRD).


Options:
A: Montgomery-Asberg Depression Rating Score (MADRS) (Baseline & week 8)
B: Part 1: Number of Participants With Moderate Intensity Adverse Events (AEs) (Up to 7 days following the last dose of study drug (Up to 23 days)); Part 1: Number of Participants With Serious Adverse Events (SAEs) (Up to 30 days following the last dose of study drug (Up to 46 days)); Part 1: Number of Participants With AEs Leading to Discontinuation of Study Drug (Up to the last dose of study drug (Up to 16 days)); Part 2: Number of Participants With AEs (Up to 7 days following the last dose of study drug (Up to 35 days)); Part 2: Number of Participants With AEs Leading to Discontinuation of Study Drug (Up to the last dose of study drug (Up to 28 days))
C: Montgomery-Asberg Depression Rating Scale (MADRS) (24 hours)
D: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Day 28 in the Double-blind Induction Phase- Mixed-Effects Model Using Repeated Measures (MMRM) Analysis (Baseline up to Day 28 of Double-blind Induction Phase); Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- Analysis of Covariance (ANCOVA) Analysis (Baseline up to Endpoint (Double-blind Induction Phase [Day 28]))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Intranasal (IN) Ketamine in Treatment-Resistant Depression (TRD)
Brief Summary: The objective of the current study is to investigate the safety and efficacy of a single dose of intranasal (IN) ketamine in treatment-resistant depression (TRD).


Options:
A: Change From Baseline to Day 1: 4-Hour Post-dose in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Double-blind Phase) (Baseline (Day 1-Predose) to Day 1: 4-hours post-dose)
B: Panel A and B: Change From Baseline (Day 1) in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Day 8- Analysis of Covariance (ANCOVA) Analysis (Baseline (Day 1) and Endpoint (Day 8) of Period 1); Panel A and B: Change From Baseline (Day 8) in Montgomery Asberg Depression Rating Scale Total Score at Day 15- ANCOVA Analysis (Baseline (Day 8) and Endpoint (Day 15) of Period 2)
C: Montgomery-Asberg Depression Rating Scale (MADRS) (24 hours)
D: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Day 28 of Double- Blind Induction Phase- Mixed- Effects Model Using Repeated Measures (MMRM) Analysis (Baseline up to Day 28 of Double-blind Induction Phase); Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis (Baseline up to Double-blind Endpoint (Day 28))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Integrated Cardiac Care and Palliative Homecare for Patients With Severe Heart Failure
Brief Summary: Patients with severe heart failure have as many symptoms as many patients with cancer but yet do not have equal access to supportive and palliative care. They have an unpredictable course of illness, which makes difficult to judge when the palliative stage has been reached. The Heart failure and Palliative care Programme is a three-year project in Sweden financed by the Swedish Association of Local Authorities and Regions (SALAR). The overall aim is to develop, implement and evaluate a model that integrates cardiac care and palliative advanced home care for patients with severe chronic heart failure. The primary aim is to study the effects on patients' symptom burden, quality of life and activities of daily living. A randomized controlled clinical study is planned.

Patients (n=62) with a confirmed diagnosis in accordance with the criteria proposed by the European Society of Cardiology and with NYHA III-IV symptoms and at least one of following criteria will be included;

1. At least one episode of worsening heart failure that resolved with injection / infusion of diuretics or the addition of other heart failure treatment in the last 6 months and regarded optimally treated according to the responsible physician.
2. Need for infusions-treatment.
3. Chronic poor quality of life (VAS \< 50)
4. Signs of cardiac cachexia (involuntary non-oedematous weight loss ≥ 6% of total body weight within the last 6-12 months)
5. less than one year life expectancy The participants will be randomized to intervention or control group. The intervention consist of a multidisciplinary approach and collaboration between specialist palliative and heart failure (HF) caregivers, in a shared structured person-centred and identity-promoting care at home during six months. Usual care is performed for the control group.


Options:
A: Change in Score on the Edmonton Symptom Assessment for patients (At baseline and 1- and 2- months following baseline); Change in Score on Hospital Anxiety and Depression Scale (HADS) for patients (At baseline and 1- and 2- months following baseline)
B: changes from baseline values of symptom scores on the the Edmonton assessment scale (ESAS) after intervention of 4, 12 and 24 weeks (baseline and after 4, 16 and 24 weeks)
C: Patient Heath Related Quality of Life (HRQL) as measured by the FACT-G, QUAL-E and FACIT-Sp. (Three months after enrollment.)
D: Healthcare utilization (up to 12 months)

Answer: B