TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Mindfulness Training for Stress Management: A Two-centre Randomised Controlled Study of Medical and Psychology Students With Long-term Follow up
Brief Summary: This study will assess the short and long term effects of a group-based mindfulness programme (Mindfulness-Based Stress Reduction, MBSR) on first year medical and psychology students at the Universities of Oslo and Tromso.

The primary outcome variables are mental distress, student stress and subsequent work stress, subjective wellbeing, empathy, mindfulness and spirituality. The investigators will also study explanatory moderator and mediator variables.

The study will be a two-centre randomized controlled study involving 288 medical and psychology students from the University of Oslo and from the University of Tromso. The sample size calculation is based on a reduction in mental distress and perceived medical/psychology school stress of 20% in the intervention group. The control group will not receive an intervention. After the initial seven week course (taking place in 2009 and 2010) the intervention group will receive a follow-up session of 1.5 hours twice a year throughout their study course of 5-6 years. The follow-up period will last until 1 year after graduation in the Oslo cohort and until 3 years after graduation in the Tromso cohort.


Options:
A: Perceived Stress Scale (At the end of five days retreat); Self-compassion (At the end of five days retreat)
B: Connor-Davidson's Resilience Scale (CDRISC; Connor and Davidson, 2003) (Up to 3 months)
C: Physician burnout (September 2010 - June 2012)
D: 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)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Mindfulness Training for Stress Management: A Two-centre Randomised Controlled Study of Medical and Psychology Students With Long-term Follow up
Brief Summary: This study will assess the short and long term effects of a group-based mindfulness programme (Mindfulness-Based Stress Reduction, MBSR) on first year medical and psychology students at the Universities of Oslo and Tromso.

The primary outcome variables are mental distress, student stress and subsequent work stress, subjective wellbeing, empathy, mindfulness and spirituality. The investigators will also study explanatory moderator and mediator variables.

The study will be a two-centre randomized controlled study involving 288 medical and psychology students from the University of Oslo and from the University of Tromso. The sample size calculation is based on a reduction in mental distress and perceived medical/psychology school stress of 20% in the intervention group. The control group will not receive an intervention. After the initial seven week course (taking place in 2009 and 2010) the intervention group will receive a follow-up session of 1.5 hours twice a year throughout their study course of 5-6 years. The follow-up period will last until 1 year after graduation in the Oslo cohort and until 3 years after graduation in the Tromso cohort.


Options:
A: 7-day point prevalence by self report (at 6 months)
B: 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)
C: Change from Baseline CORE-OM measure at post-intervention and 4-month follow-up. (It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.)
D: Change from baseline in ED staff burn out using the Maslach Burnout Inventory (MBI) (Week 8 and 20)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Mindfulness Training for Stress Management: A Two-centre Randomised Controlled Study of Medical and Psychology Students With Long-term Follow up
Brief Summary: This study will assess the short and long term effects of a group-based mindfulness programme (Mindfulness-Based Stress Reduction, MBSR) on first year medical and psychology students at the Universities of Oslo and Tromso.

The primary outcome variables are mental distress, student stress and subsequent work stress, subjective wellbeing, empathy, mindfulness and spirituality. The investigators will also study explanatory moderator and mediator variables.

The study will be a two-centre randomized controlled study involving 288 medical and psychology students from the University of Oslo and from the University of Tromso. The sample size calculation is based on a reduction in mental distress and perceived medical/psychology school stress of 20% in the intervention group. The control group will not receive an intervention. After the initial seven week course (taking place in 2009 and 2010) the intervention group will receive a follow-up session of 1.5 hours twice a year throughout their study course of 5-6 years. The follow-up period will last until 1 year after graduation in the Oslo cohort and until 3 years after graduation in the Tromso cohort.


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: Professional Quality of Life Scale-IV (ProQoL), "change" is being assessed. (Change from Baseline up to 1 year); Perceived Stress Scale, "change" is being assessed. (Change from Baseline up to 1 year); Resilience Scale for Adults, "change" is being assessed. (Change from Baseline up to 1 year)
C: Change from baseline Perceived Stress Scale (PSS) score at 4, 8 weeks (Baseline and after 4, 8 weeks later)
D: Job satisfaction (baseline to 3 month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase I/Randomized Phase II Double Blind Study of Either Dasatinib or Placebo Combined With Bevacizumab in Recurrent Glioblastoma
Brief Summary: RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also block the growth of the tumor by blocking blood flow to the tumor. It is not yet known whether bevacizumab together with dasatinib are more effective than a placebo in treating patients with recurrent or progressive high-grade glioma or glioblastoma multiforme.

PURPOSE: This randomized phase I/II trial (Phase I completed) is studying the side effects and best dose of dasatinib when given together with bevacizumab and to see how well it works compared to placebo in treating patients with recurrent or progressive high-grade glioma or glioblastoma multiforme.


Options:
A: Maximum Tolerated Dose (MTD) DNX-2401 (Assessed during 14 day waiting period between doses (every 28 days).)
B: Number of Participants With Dose Limiting Toxicities to Determine Maximum Tolerated Dose (MTD) of Dasatinib in Combination With Bevacizumab (Phase I) (14 days); Progression-free Survival at 6 Months (PFS6) (Phase II) (6 months)
C: Overall survival (Date of randomization to date of death from any cause estimated up to 2 years)
D: Overall Survival (7 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Phase II Trial of Pemetrexed vs. Pemetrexed/Bevacizumab vs. Pemetrexed/Carboplatin/Bevacizumab in Patients With Stage IIIB/IV Non-Small-Cell Lung Cancer and ECOG Performance Status 2
Brief Summary: The purpose of this trial is to evaluate three treatment regimens in patients with stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) with a performance status of 2 and who were not previously treated.


Options:
A: Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint (Randomization until 199 deaths, up to November 2014, approximately 25 months); Overall Survival (OS) Rate in All Randomized Participants (Randomization to 18 months post-randomization, up to June 2015); Number of Deaths From Any Cause in All Randomized Participants at Primary Endpoint (Randomization until 199 deaths, up to November 2014, approximately 25 months)
B: Overall survival (OS) (approximately 48 months); Progression-free Survival (PFS) as determined by blinded independent central review (BICR) (approximately 40 months)
C: overall survival (one year)
D: Progression Free Survival (PFS) (18 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity & Safety Study of GSK Biologicals' 208136 Vaccine Formulated With New Measles and Rubella Working Seeds
Brief Summary: This study is undertaken to generate clinical data on GSK Biologicals' combined measles-mumps-rubella-varicella vaccine manufactured with measles and rubella obtained from newly established working seed viruses which are one passage further than the current working seed viruses. The measles-mumps-rubella-varicella vaccine manufactured with the current working seed viruses will serve as comparator.

A seed lot system is a system according to which successive batches of a vaccine are derived from the same master seed virus. For routine production, a working seed lot is prepared from the master seed virus.


Options:
A: Number of Subjects With Booster Responses to Diphteria and Tetanus (One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.); Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (FHA) and Anti-pertactin (Anti-PRN) Booster Responses, Measured in Enzyme-Linked Immunosorbent Assay Units Per Milliliter (EL.U/mL) (One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.); Geometric Mean Titers (GMTs) for Antibodies to Poliovirus Types 1, 2 and 3 (One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.)
B: Seropositivity rate & antibody titers for MMRV at 1, 2 & 3 year; Occurrence of breakthrough cases & contacts with MMRV disease(s) for 3 years after vaccination
C: Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series (One month after the 3-dose infant series (7 months of age)); Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose (1 Month After the Toddler Dose); Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series (One Month After the Infant Series (7 months of age)); Percentage of Participants Reporting Pre-specified Systemic Events (Within 7 days after each dose); Percentage of Participants Reporting Pre-specified Local Reactions (Within 7 days after each dose)
D: Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies Greater Than or Equal to (≥) the Cut-off Value. (At 42-56 days after the first dose of study vaccine (Week 6))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial of Single Port Laparoscopic Cholecystectomy Versus Four Port Laparoscopic Cholecystectomy
Brief Summary: This is a single-institution, prospective, one-to-one randomized controlled research study. Subjects medically determined to need a cholecystectomy will be consented for surgery and study participation prior to enrolment in this study. Patients will then be randomized to receive either a single port laparoscopic cholecystectomy or a four port laparoscopic cholecystectomy.


Options:
A: Postoperative Quality of Life (QoL) (one month)
B: Post-operative pain scores (visual analogue pain scale from 0-10) (Before surgery (baseline) and 2 hrs, 4 hrs, 6hrs, 12hrs, 24hrs and 48hrs after surgery)
C: Post-operative pain scores (visual analogue pain scale from 0-10)assessed on post-operative day 1 and at the post-operative follow up visit in clinic. The mean pain scores will be compared using student's t-test. (3-6 weeks)
D: SILS cholecystectomy, except the invisible scar, has significantly less abdominal and shoulder pain scores

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Primary Prevention of Rapid Weight Gain in Early Childhood: a Randomised Controlled Trial
Brief Summary: Obesity is one of the biggest threats to health in the 21st century. Rapid weight gain in the first year of life tends to lead to overweight in children, which in turn leads to overweight in adults. This rapid early weight gain occurs most often at weaning when eating patterns emerge. Infant sleep problems also appear to be associated with the risk of becoming overweight, and contribute to maternal post-natal depression. We propose to undertake a 4-arm randomised controlled trial to determine whether extra education and support for families around weaning and development of early food and activity habits, with or without intervention to improve infant sleep, will decrease the current risk patterns of rapid excessive early childhood weight gain in New Zealand. This would provide strong evidence for the value of such a strategy in the long term control of the obesity epidemic and its consequent complications.

This is a two-year intervention with follow-ups at 3.5, 5 and 11 years of age.


Options:
A: BMI z score (24 months (end of intervention)); BMI z score (60 months of age (followup at 5 years of age)); BMI z score (Follow-up at 11 years of age)
B: Mother BMI (Baseline, 6 months, 12 months); Infant Weight (Baseline, 6 months, 12 months)
C: Group differences in percentage of mothers who meet breastfeeding and complementary feeding recommendations and percentage of mothers who introduce sugar sweetened beverages over time as assessed by the Child Feeding Assessment. (2 weeks - 24 months postpartum); Group differences in mean scores for infant feeding style subscales assessed using the Infant Feeding Behavior Questionnaire. (2 months-12 months postpartum); Group differences in in mean scores for toddler feeding style subscales assessed using the Toddler Feeding Behavior Questionnaire (TFBQ). (24 months postpartum); Group differences in children's fruit and vegetable intake, sugar sweetened beverage (SSB) consumption, snacks, and desserts over time. (6 and 24 months postpartum); Group differences in children's physical activity levels as assessed by accelerometry. (18 months-24 months postpartum); Group differences in children's reported physical activity, screen time and other sedentary activities over time as assessed by the Child Physical Activity Assessment. (2 weeks-24 months postpartum); Group differences in children's mean BMI z-scores over time as assessed through child weight and length measurements over time. (2 weeks-24 months postpartum)
D: 1-year, and 3-year changes from baseline in questionaires scores for knowledge, attitudes, and habits of children, parents and teachers in regards to a healthy lifestyle. (3 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Primary Prevention of Rapid Weight Gain in Early Childhood: a Randomised Controlled Trial
Brief Summary: Obesity is one of the biggest threats to health in the 21st century. Rapid weight gain in the first year of life tends to lead to overweight in children, which in turn leads to overweight in adults. This rapid early weight gain occurs most often at weaning when eating patterns emerge. Infant sleep problems also appear to be associated with the risk of becoming overweight, and contribute to maternal post-natal depression. We propose to undertake a 4-arm randomised controlled trial to determine whether extra education and support for families around weaning and development of early food and activity habits, with or without intervention to improve infant sleep, will decrease the current risk patterns of rapid excessive early childhood weight gain in New Zealand. This would provide strong evidence for the value of such a strategy in the long term control of the obesity epidemic and its consequent complications.

This is a two-year intervention with follow-ups at 3.5, 5 and 11 years of age.


Options:
A: BMI percentile at 3 years (3 years)
B: Child BMI
C: BMI z score (24 months (end of intervention)); BMI z score (60 months of age (followup at 5 years of age)); BMI z score (Follow-up at 11 years of age)
D: % Body Fat (Boys) (Baseline and 3 years); BMI Z-score (Boys) (Baseline and three years); % Body Fat (Girls) (Baseline and 3 years); BMI Z-score (Girls) (Baseline and three years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Primary Prevention of Rapid Weight Gain in Early Childhood: a Randomised Controlled Trial
Brief Summary: Obesity is one of the biggest threats to health in the 21st century. Rapid weight gain in the first year of life tends to lead to overweight in children, which in turn leads to overweight in adults. This rapid early weight gain occurs most often at weaning when eating patterns emerge. Infant sleep problems also appear to be associated with the risk of becoming overweight, and contribute to maternal post-natal depression. We propose to undertake a 4-arm randomised controlled trial to determine whether extra education and support for families around weaning and development of early food and activity habits, with or without intervention to improve infant sleep, will decrease the current risk patterns of rapid excessive early childhood weight gain in New Zealand. This would provide strong evidence for the value of such a strategy in the long term control of the obesity epidemic and its consequent complications.

This is a two-year intervention with follow-ups at 3.5, 5 and 11 years of age.


Options:
A: Karitane parenting confidence scale, KPCS. Change is being assessed. (measured at 2 weeks, 3 and 9 months post partum); Infant Care Index (measured 4 months post partum); Ages & States questionnarie, ASQ-SE. Change is being assessed. (measured at 2 weeks, 3 and 9 months post partum)
B: Mean weight-for-length z-score at 15 months of age (15 months of age)
C: Exclusive breastfeeding (6 months postpartum)
D: BMI z score (24 months (end of intervention)); BMI z score (60 months of age (followup at 5 years of age)); BMI z score (Follow-up at 11 years of age)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Primary Prevention of Rapid Weight Gain in Early Childhood: a Randomised Controlled Trial
Brief Summary: Obesity is one of the biggest threats to health in the 21st century. Rapid weight gain in the first year of life tends to lead to overweight in children, which in turn leads to overweight in adults. This rapid early weight gain occurs most often at weaning when eating patterns emerge. Infant sleep problems also appear to be associated with the risk of becoming overweight, and contribute to maternal post-natal depression. We propose to undertake a 4-arm randomised controlled trial to determine whether extra education and support for families around weaning and development of early food and activity habits, with or without intervention to improve infant sleep, will decrease the current risk patterns of rapid excessive early childhood weight gain in New Zealand. This would provide strong evidence for the value of such a strategy in the long term control of the obesity epidemic and its consequent complications.

This is a two-year intervention with follow-ups at 3.5, 5 and 11 years of age.


Options:
A: Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment (0, 3 months); Change in Children´s Time of Physical Activity From Baseline to 3 Months by Intervention Assignment (0, 3 months); Change in Score z of Body Mass Index From Baseline to 3 Months by Intervention Assignment (0, 3 month)
B: Mother BMI (Baseline, 6 months, 12 months); Infant Weight (Baseline, 6 months, 12 months)
C: Satisfaction and Exit Survey Composite Scale Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE (6 weeks)
D: BMI z score (24 months (end of intervention)); BMI z score (60 months of age (followup at 5 years of age)); BMI z score (Follow-up at 11 years of age)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Primary Prevention of Rapid Weight Gain in Early Childhood: a Randomised Controlled Trial
Brief Summary: Obesity is one of the biggest threats to health in the 21st century. Rapid weight gain in the first year of life tends to lead to overweight in children, which in turn leads to overweight in adults. This rapid early weight gain occurs most often at weaning when eating patterns emerge. Infant sleep problems also appear to be associated with the risk of becoming overweight, and contribute to maternal post-natal depression. We propose to undertake a 4-arm randomised controlled trial to determine whether extra education and support for families around weaning and development of early food and activity habits, with or without intervention to improve infant sleep, will decrease the current risk patterns of rapid excessive early childhood weight gain in New Zealand. This would provide strong evidence for the value of such a strategy in the long term control of the obesity epidemic and its consequent complications.

This is a two-year intervention with follow-ups at 3.5, 5 and 11 years of age.


Options:
A: Child anthropometry (Baseline. Up to 12 months. Up to 24 months.); Child food intake (Baseline. Up to 12 months. Up to 24 months.); Child health (Baseline. Up to 12 months. Up to 24 months.); Distribution of food intake within the household (Baseline. Up to 12 months. Up to 24 months.); Household food security (Baseline. Up to 12 months. Up to 24 months.); Maternal nutrition knowledge (Baseline. Up to 12 months. Up to 24 months.)
B: BMI percentile at 3 years (3 years)
C: BMI z score (24 months (end of intervention)); BMI z score (60 months of age (followup at 5 years of age)); BMI z score (Follow-up at 11 years of age)
D: BMI and aerobic fitness (1 schoolyear)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Primary Prevention of Rapid Weight Gain in Early Childhood: a Randomised Controlled Trial
Brief Summary: Obesity is one of the biggest threats to health in the 21st century. Rapid weight gain in the first year of life tends to lead to overweight in children, which in turn leads to overweight in adults. This rapid early weight gain occurs most often at weaning when eating patterns emerge. Infant sleep problems also appear to be associated with the risk of becoming overweight, and contribute to maternal post-natal depression. We propose to undertake a 4-arm randomised controlled trial to determine whether extra education and support for families around weaning and development of early food and activity habits, with or without intervention to improve infant sleep, will decrease the current risk patterns of rapid excessive early childhood weight gain in New Zealand. This would provide strong evidence for the value of such a strategy in the long term control of the obesity epidemic and its consequent complications.

This is a two-year intervention with follow-ups at 3.5, 5 and 11 years of age.


Options:
A: BMI z score (24 months (end of intervention)); BMI z score (60 months of age (followup at 5 years of age)); BMI z score (Follow-up at 11 years of age)
B: Change in child sugar-sweetened beverage consumption from baseline to 6 months (Baseline, 6 months)
C: Body Mass Index score(BMI sds) at the age 6 years to monitor the effectiveness of the intervention (5 years)
D: For adults: body weight loss maintenance (6 Month)

Answer: A