TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of a Training Program in Mindfulness and Self-Compassion of 4 Sessions in Front of the 8 Sessions to Reduce Work Stress and Burnout in Professionals of Medicine and Nursing (MINDUUDD Project)
Brief Summary: The objective is to check whether a training program in mindfulness and self-pity based on a 4-session intervention (abbreviated program) is as effective as the standard 8-session MBSR program in reducing work stress and burnout in tutors and residents of Medicine and Family and Community Nursing.

It is a controlled clinical trial, randomized by cluster, of three parallel arms, multicentric. Six teaching units (ratio 1: 1: 1) will be randomized to one of the three study groups: 1) Experimental Group-8 (EG8); 2) Experimental Group-4 (EG4); 3) Control group (CG).

At least 132 subjects will participate, 44 in the EG8, 44 in the EG4 and 44 in the CG.

The interventions will be based on the MBSR (Mindfulness Based Stress Reduction) program, to which some of the practices of the MSC (Mindful Self-Compassion) program will be added.

The EG8 intervention will be carried out during 8 weekly sessions of 2.5 hours, while the EG4 intervention will be of 4 sessions of 2.5 hours. The participants will have to practice at home for 30 minutes / day in the EG8 and 15 minutes / day in the EG4.

In the 3 groups the questionnaires FFMQ (mindfulness), SCS (self-pity), ordinal scale (0-10) and questionnaire PSQ (perceived stress) and MBI (burnout) will be passed. Empathy will also be measured, through the EEMJ, anxiety and depression disorders (EADG) and self-perceived health status.


Options:
A: The Anxiety Disorder Scale (A week); The Grief Inventory (A week); The Coping Mechanisms Scale (A week); The Psychiatric Morbidity Scale (A week); The Physical Symptoms Scale (A week); The Insomnia Scale (A week); The Binge Eating Scale (A week); The Burnout Inventory (A week); Alcohol use (A week); Drug use (A week)
B: Degree of occupational stress (Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG)); Degree of occupational stress (Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG)); Degree of burnout (Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG)); Degree of Self-Compassion (Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG))
C: Changes in subjective symptoms of well-being at work (baseline, 4 weeks, 8 weeks); Changes in subjective symptoms of stress (baseline, 4 weeks, 8 weeks)
D: Change in level of stress per Perceived Stress Scale (PSS) (Baseline and at 2 months (immediately post-intervention))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of a Training Program in Mindfulness and Self-Compassion of 4 Sessions in Front of the 8 Sessions to Reduce Work Stress and Burnout in Professionals of Medicine and Nursing (MINDUUDD Project)
Brief Summary: The objective is to check whether a training program in mindfulness and self-pity based on a 4-session intervention (abbreviated program) is as effective as the standard 8-session MBSR program in reducing work stress and burnout in tutors and residents of Medicine and Family and Community Nursing.

It is a controlled clinical trial, randomized by cluster, of three parallel arms, multicentric. Six teaching units (ratio 1: 1: 1) will be randomized to one of the three study groups: 1) Experimental Group-8 (EG8); 2) Experimental Group-4 (EG4); 3) Control group (CG).

At least 132 subjects will participate, 44 in the EG8, 44 in the EG4 and 44 in the CG.

The interventions will be based on the MBSR (Mindfulness Based Stress Reduction) program, to which some of the practices of the MSC (Mindful Self-Compassion) program will be added.

The EG8 intervention will be carried out during 8 weekly sessions of 2.5 hours, while the EG4 intervention will be of 4 sessions of 2.5 hours. The participants will have to practice at home for 30 minutes / day in the EG8 and 15 minutes / day in the EG4.

In the 3 groups the questionnaires FFMQ (mindfulness), SCS (self-pity), ordinal scale (0-10) and questionnaire PSQ (perceived stress) and MBI (burnout) will be passed. Empathy will also be measured, through the EEMJ, anxiety and depression disorders (EADG) and self-perceived health status.


Options:
A: The primary outcome variables are mental distress (GHQ12, SCL5 and MBI), student stress (PMSS) and subsequent work stress, subjective wellbeing (SWB), empathy (JPSE), mindfulness (FFMS) (9 years)
B: 30 day point prevalence abstinence (12 months)
C: Change in the maintenance of abstinence from Cessation of tobacco use through assessment interviews (self-report and CO monitor will be used), and the point prevalence (baseline and twelve months)
D: Degree of occupational stress (Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG)); Degree of occupational stress (Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG)); Degree of burnout (Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG)); Degree of Self-Compassion (Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase Ib Study of Tisagenlecleucel in Combination With Pembrolizumab in Relapsed/Refractory (r/r) Diffuse Large B-cell Lymphoma (DLBCL) Patients.
Brief Summary: A multi-center, open-label, phase Ib study to evaluate the safety and efficacy of the administration of tisagenlecleucel in combination with pembrolizumab in patients with r/r DLBCL who have received 2 or more lines of systemic therapy, including an anti-CD20 and anthracycline based chemotherapy and having failed to or are not candidates for ASCT. The study will consist of 2 parts: dose timing selection part and expansion part.


Options:
A: Phase I - Identification of the dose limiting toxicity (DLT) (4 weeks after CAR T cell infusion); Phase II - Efficacy (4 weeks after CAR T cell infusion)
B: Overall Response Rate (ORR) Per Independent Review Committee in Cohorts 1, 2 and 3 (From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)); Overall Response Rate (ORR) Per Investigator in Cohort 4 (From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)); Overall Response Rate (ORR) Per Investigator in Cohort 5 (From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)); Number of Participants With Adverse Events in Cohort 7 (From leukapheresis to end of study (up to approximately 63 months)); Number of Participants With Serious Adverse Events (SAEs) in Cohort 7 (From leukapheresis to end of study (up to approximately 63 months)); Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohort 7 (At Baseline and Day 29 after JCAR017 infusion); Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohort 7 (At Baseline and Day 29 after JCAR017 infusion)
C: Percent of participants recieving pembrolizumab per protocol schedule (21 days after first pembrolizumab infusion); Dose Timing part: Incidence of dose limiting toxicities (DLTs) (21 days after first pembrolizumab infusion); Expansion part: Overall response rate (ORR) (3 month post tisagenlecleucel infusion)
D: Percentage of Participants With Overall Remission Rate (ORR) as Determined by Independent Review Committee (IRC) Assessment. (during the 3 months after tisagenlecleucel administration)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effectiveness of a Low-intensity, Lay Counsellor-delivered, Problem-solving Intervention for Common Mental Health Problems in School-going Adolescents in New Delhi, India: the PRIDE Study Protocol for a Randomized Controlled Trial
Brief Summary: We will conduct a two-arm individually randomized controlled trial in six Government-run secondary schools in New Delhi. The targeted sample is 240 adolescents in grades 9-12 with persistent, elevated mental health difficulties and associated impact. Participants will receive either a brief problem-solving intervention delivered by lay counsellors (intervention), or enhanced usual care comprised of problem-solving booklets (control). Self-reported adolescent mental health difficulties and idiographic problems will be assessed at 6 weeks (co-primary outcomes) and again at 12 weeks post-randomization. In addition, adolescent-reported impact of mental health difficulties, perceived stress, mental wellbeing and clinical remission, as well as parent-reported adolescent mental health difficulties and impact scores, will be assessed at 6 and 12 weeks post-randomization. Parallel process evaluation, including estimations of the costs of delivering the interventions, will be conducted.


Options:
A: Appetitive aggression (sumscore; 0-60 indicating higher levels) (Change from baseline to 3-5 and 6-9 months post treatment); Current violent behavior (sumscore; 0-96 indicating more acts) (Change from baseline to 3-5 and 6-9 months post treatment)
B: Mental health symptoms (6 weeks); Idiographic problems (6 weeks)
C: CD4 count (6-monthly); RNA viral load (6-monthly); Haemoglobin (6-monthly); self-reported adherence (CASE index) (6-monthly); health-related quality of life (EQ-5D/EQ-VAS) (6-monthly); anthropometrics (monthly to 6-monthly); food security (USDA scales) (6-monthly); time allocation/physical activity levels (6-monthly); household welfare (6-monthly)
D: Primary Outcome Measure(s) evaluate the efficacy and cost-effectiveness of the intervention in reducing carer burden, improving behaviour problems in elderly persons with dementia and reducing the costs of illness. (by the end of the study)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effectiveness of a Low-intensity, Lay Counsellor-delivered, Problem-solving Intervention for Common Mental Health Problems in School-going Adolescents in New Delhi, India: the PRIDE Study Protocol for a Randomized Controlled Trial
Brief Summary: We will conduct a two-arm individually randomized controlled trial in six Government-run secondary schools in New Delhi. The targeted sample is 240 adolescents in grades 9-12 with persistent, elevated mental health difficulties and associated impact. Participants will receive either a brief problem-solving intervention delivered by lay counsellors (intervention), or enhanced usual care comprised of problem-solving booklets (control). Self-reported adolescent mental health difficulties and idiographic problems will be assessed at 6 weeks (co-primary outcomes) and again at 12 weeks post-randomization. In addition, adolescent-reported impact of mental health difficulties, perceived stress, mental wellbeing and clinical remission, as well as parent-reported adolescent mental health difficulties and impact scores, will be assessed at 6 and 12 weeks post-randomization. Parallel process evaluation, including estimations of the costs of delivering the interventions, will be conducted.


Options:
A: Mental health symptoms (6 weeks); Idiographic problems (6 weeks)
B: Change in Health of Nations Outcomes Scale (HoNOS) score from baseline (Baseline, 6 months and 12 months); Change in Clinical Interview Schedule Revised (CIS-R) score from baseline (Baseline, 6 months and 12 months)
C: depression symptom severity (3-6 months)
D: Rate of Maternal HIV Viral Suppression (Two months post pregnancy); Mean Maternal Antiretroviral (ART) Adherence (Past 6 months, assessed at 2 months after the completion of pregnancy); Rate of Prevention of Mother-to-child-transmission (PMTCT) Care Retention (through study completion, an average of 48 weeks); Rate of Delivery in Health Facility (two months post pregnancy); Rate of Infant Use of ART (First 6 weeks of life)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo Controlled, Double Blind, Double Dummy, Multicenter Trial Comparing Electronic Cigarettes With Nicotine to Varenicline and to Electronic Cigarettes Without Nicotine.
Brief Summary: Background:

Electronic cigarettes (EC) mainly containing nicotine (88-95 % of users) are widely and growingly used worldwide. It is estimated that there were 1.7 million daily users in France in 2016. Although the number of publications about its use is increasing exponentially, there are no evidence based, unbiased, head-to-head comparison data about its efficacy as an aid to smoking cessation. As of today, only two head-to-head randomized studies have been published, both reported negative results at the main endpoint but they used first and second generation EC delivering nicotine with low or unknown bioavailability. Recent EC deliver nicotine with largely improved bioavailability.

One of the randomized studies compared EC with and without nicotine to nicotine patch and reported similar smoking cessation rate at main outcome. However, there is no published, double blind study comparing EC use with a well-studied, licensed smoking cessation medication.

Superiority of EC with nicotine compared to EC without nicotine and to a reference smoking cessation medication while collecting also straightforward information about safety, would allow proposing EC with nicotine to the large population of smokers who intend to quit and situate it among the approved smoking cessation treatments.

The clinical study's hypothesis:

EC containing nicotine can be considered as a nicotine replacement therapy having, probably, a better bioavailability of nicotine than the marketed pharmaceutical NRTs, first line medications of smoking cessation. It is therefore of interest to compare EC containing nicotine to EC without nicotine but also to a reference medication with demonstrated efficacy in smoking cessation. We hypothesize that EC with nicotine provides a higher smoking abstinence rate than EC without nicotine and may be as good as varenicline, our reference medication.


Options:
A: Continuous smoking abstinence rate (Weeks 9 to 12)
B: Quit Rate (4 months)
C: Number of Participants Reporting Continuous Smoking Abstinence in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions. (Last 4 weeks of treatment); Mean Percentage of Heavy Drinking Days Comparing Participants in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions (First 3 weeks (pretreatment))
D: 4 week continuous quit rate (CQR) at Weeks 9-12 and Weeks 4-7

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo Controlled, Double Blind, Double Dummy, Multicenter Trial Comparing Electronic Cigarettes With Nicotine to Varenicline and to Electronic Cigarettes Without Nicotine.
Brief Summary: Background:

Electronic cigarettes (EC) mainly containing nicotine (88-95 % of users) are widely and growingly used worldwide. It is estimated that there were 1.7 million daily users in France in 2016. Although the number of publications about its use is increasing exponentially, there are no evidence based, unbiased, head-to-head comparison data about its efficacy as an aid to smoking cessation. As of today, only two head-to-head randomized studies have been published, both reported negative results at the main endpoint but they used first and second generation EC delivering nicotine with low or unknown bioavailability. Recent EC deliver nicotine with largely improved bioavailability.

One of the randomized studies compared EC with and without nicotine to nicotine patch and reported similar smoking cessation rate at main outcome. However, there is no published, double blind study comparing EC use with a well-studied, licensed smoking cessation medication.

Superiority of EC with nicotine compared to EC without nicotine and to a reference smoking cessation medication while collecting also straightforward information about safety, would allow proposing EC with nicotine to the large population of smokers who intend to quit and situate it among the approved smoking cessation treatments.

The clinical study's hypothesis:

EC containing nicotine can be considered as a nicotine replacement therapy having, probably, a better bioavailability of nicotine than the marketed pharmaceutical NRTs, first line medications of smoking cessation. It is therefore of interest to compare EC containing nicotine to EC without nicotine but also to a reference medication with demonstrated efficacy in smoking cessation. We hypothesize that EC with nicotine provides a higher smoking abstinence rate than EC without nicotine and may be as good as varenicline, our reference medication.


Options:
A: Electronic cigarette use (weekly measurements from baseline to 10 weeks and a final assessment at 24 weeks); electronic cigarette acceptability (Baseline, week 2, week6, week 10 and week 24); Respiratory symptoms (weekly measures from baseline to 10 weeks and at 24 weeks); Cotinine (Baseline, week 2, 6, 10 and 24); Nitrosamines (Baseline and at 6 week); Side effects of antipsychotics (weekly the first 10 weeks and at 24 weeks); Withdrawal symptoms (weekly the first 10 weeks and at 24 weeks); Respiratory symptoms (weekly the first 10 weeks and at 24 weeks)
B: Traditional smoking cessation rate (5 years); Change from baseline in the number of traditional cigarette smoked (6, 12, 24, 36 and 60 months.)
C: Continuous smoking abstinence rate (Weeks 9 to 12)
D: 7-day point prevalent CO validated smoking cessation. (Three months after lung screening)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo Controlled, Double Blind, Double Dummy, Multicenter Trial Comparing Electronic Cigarettes With Nicotine to Varenicline and to Electronic Cigarettes Without Nicotine.
Brief Summary: Background:

Electronic cigarettes (EC) mainly containing nicotine (88-95 % of users) are widely and growingly used worldwide. It is estimated that there were 1.7 million daily users in France in 2016. Although the number of publications about its use is increasing exponentially, there are no evidence based, unbiased, head-to-head comparison data about its efficacy as an aid to smoking cessation. As of today, only two head-to-head randomized studies have been published, both reported negative results at the main endpoint but they used first and second generation EC delivering nicotine with low or unknown bioavailability. Recent EC deliver nicotine with largely improved bioavailability.

One of the randomized studies compared EC with and without nicotine to nicotine patch and reported similar smoking cessation rate at main outcome. However, there is no published, double blind study comparing EC use with a well-studied, licensed smoking cessation medication.

Superiority of EC with nicotine compared to EC without nicotine and to a reference smoking cessation medication while collecting also straightforward information about safety, would allow proposing EC with nicotine to the large population of smokers who intend to quit and situate it among the approved smoking cessation treatments.

The clinical study's hypothesis:

EC containing nicotine can be considered as a nicotine replacement therapy having, probably, a better bioavailability of nicotine than the marketed pharmaceutical NRTs, first line medications of smoking cessation. It is therefore of interest to compare EC containing nicotine to EC without nicotine but also to a reference medication with demonstrated efficacy in smoking cessation. We hypothesize that EC with nicotine provides a higher smoking abstinence rate than EC without nicotine and may be as good as varenicline, our reference medication.


Options:
A: Continuous smoking abstinence rate (Weeks 9 to 12)
B: Number of participants reported adverse events of e-cigarettes or nicotine pouches (60 Weeks); Change in the number of combustible cigarettes per day (60 Weeks); Point-prevalence abstinence (60 Weeks)
C: Continuous smoking abstinence (1) (6 months post quit date)
D: Proportion of Daily Cigarettes Smoked in the 4 Hours After Receiving Methadone Dose (7 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo Controlled, Double Blind, Double Dummy, Multicenter Trial Comparing Electronic Cigarettes With Nicotine to Varenicline and to Electronic Cigarettes Without Nicotine.
Brief Summary: Background:

Electronic cigarettes (EC) mainly containing nicotine (88-95 % of users) are widely and growingly used worldwide. It is estimated that there were 1.7 million daily users in France in 2016. Although the number of publications about its use is increasing exponentially, there are no evidence based, unbiased, head-to-head comparison data about its efficacy as an aid to smoking cessation. As of today, only two head-to-head randomized studies have been published, both reported negative results at the main endpoint but they used first and second generation EC delivering nicotine with low or unknown bioavailability. Recent EC deliver nicotine with largely improved bioavailability.

One of the randomized studies compared EC with and without nicotine to nicotine patch and reported similar smoking cessation rate at main outcome. However, there is no published, double blind study comparing EC use with a well-studied, licensed smoking cessation medication.

Superiority of EC with nicotine compared to EC without nicotine and to a reference smoking cessation medication while collecting also straightforward information about safety, would allow proposing EC with nicotine to the large population of smokers who intend to quit and situate it among the approved smoking cessation treatments.

The clinical study's hypothesis:

EC containing nicotine can be considered as a nicotine replacement therapy having, probably, a better bioavailability of nicotine than the marketed pharmaceutical NRTs, first line medications of smoking cessation. It is therefore of interest to compare EC containing nicotine to EC without nicotine but also to a reference medication with demonstrated efficacy in smoking cessation. We hypothesize that EC with nicotine provides a higher smoking abstinence rate than EC without nicotine and may be as good as varenicline, our reference medication.


Options:
A: Continuous smoking abstinence rate (Weeks 9 to 12)
B: verified abstinence 6 months (6 months)
C: Change in Carbon Monoxide Level (Baseline, 2 week, 4 week, 6 week, 8 week, 13 week, 26 week); Change in Cancer Related Toxin, 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol or NNAL (Baseline, 4 week, 8 week, 13 week, 26 week); Change in the use of e-cigarettes (Baseline, 2 week, 4 week, 6 week, 8 week, 13 week, 26 week)
D: Traditional smoking cessation rate (5 years); Change from baseline in the number of traditional cigarette smoked (6, 12, 24, 36 and 60 months.)

Answer: A