TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Web-based Self-management Intervention to Increase Level of Physical Activity and Decrease Use of Health Care for People With COPD, in Primary Care: A Protocol for a Randomized Controlled Clinical Trial
Brief Summary: This study evaluates the effects of the COPD Web (KOLwebben), an interactive web-based tool directed towards people with chronic obstructive pulmonary disease (COPD). The COPD Web include tools that improve health literacy with a specific focus on 1) increased physical activity and 2) use of appropriate self-management strategies. This randomized clinical trial aims to generate evidence on the effect and usability of the COPD Web in a properly powered cohort of patients in primary care context.


Options:
A: Effectiveness of an Tele Respiratory Rehabiltation program (TeleRehab) in the maintenance of benefits after an intensive respiratory rehabilitation program evaluated through the 6 m Walking test and health quality questionnaires after 12 months (One Year)
B: Combined number of hospitalizations and emergency department presentations (Two years)
C: Treatment Adherence (10 months)
D: Change in level of objectively measured physical activity (7 Days at baseline, 7 days at 3- and 12- months after baseline)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Web-based Self-management Intervention to Increase Level of Physical Activity and Decrease Use of Health Care for People With COPD, in Primary Care: A Protocol for a Randomized Controlled Clinical Trial
Brief Summary: This study evaluates the effects of the COPD Web (KOLwebben), an interactive web-based tool directed towards people with chronic obstructive pulmonary disease (COPD). The COPD Web include tools that improve health literacy with a specific focus on 1) increased physical activity and 2) use of appropriate self-management strategies. This randomized clinical trial aims to generate evidence on the effect and usability of the COPD Web in a properly powered cohort of patients in primary care context.


Options:
A: Number of Participants with Hospital Readmission at 6 months (6 months)
B: Change in 6-minute walk test (Baseline, 8 weeks and 12 months)
C: Change in level of objectively measured physical activity (7 Days at baseline, 7 days at 3- and 12- months after baseline)
D: Composite measure of psychological quality of life, composite index of all cause mortality and COPD-related hospitalization. (4 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Group Focused Psychosocial Support to Improve the Psychosocial Well-being and Functioning of Adults Affected by Humanitarian Crisis in Nepal
Brief Summary: This is an effectiveness study of group problem management plus, a low-intensity psychological intervention, delivered in five sessions to adults affected by humanitarian crises. The current study will evaluate the effectiveness of Group Problem Management Plus (PM+).


Options:
A: General psychological distress - General Health Questionnaire (20-weeks after baseline)
B: Change in Grief Intensity (Baseline, 2 months post-intervention); Change in Mental Health (Baseline, 2 months post-intervention)
C: Depression - Patient Health Questionnaire (1 week post-intervention)
D: Diabetes-related distress (6-week (immediate post-intervention) [T1]); Diabetes-related distress (6-month [T2]); Diabetes-related distress (12-month [T3])

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Group Focused Psychosocial Support to Improve the Psychosocial Well-being and Functioning of Adults Affected by Humanitarian Crisis in Nepal
Brief Summary: This is an effectiveness study of group problem management plus, a low-intensity psychological intervention, delivered in five sessions to adults affected by humanitarian crises. The current study will evaluate the effectiveness of Group Problem Management Plus (PM+).


Options:
A: Recovery from Common Mental Disorder (defined by ICD10) (6 months)
B: General psychological distress - General Health Questionnaire (20-weeks after baseline)
C: Post Traumatic Stress Disorder- Reaction Index (RI) (Baseline and Follow-up within one month of treatment completion. For controls follow up was 4 months post baseline.)
D: Reduction in Post-traumatic Stress Reaction Symptoms Among Participants (1-week before intervention, 3-weeks later)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Group Focused Psychosocial Support to Improve the Psychosocial Well-being and Functioning of Adults Affected by Humanitarian Crisis in Nepal
Brief Summary: This is an effectiveness study of group problem management plus, a low-intensity psychological intervention, delivered in five sessions to adults affected by humanitarian crises. The current study will evaluate the effectiveness of Group Problem Management Plus (PM+).


Options:
A: Number of Participants With Combined Common Mental Disorders (CMDs, i.e. Anxiety and Depression). (6 weeks postpartum)
B: Depressive symptom change (baseline, 3-, 6-, and 12-month follow up)
C: General psychological distress - General Health Questionnaire (20-weeks after baseline)
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: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Adding a Personalised Smoking Cessation Intervention to a Lung Cancer Screening Programme
Brief Summary: Lung cancer rates are higher in Yorkshire than the rest of the UK, and this is due to higher rates of smoking. Deaths from lung cancer can be reduced using regular lung scans (screening) and by helping people stop smoking. As well as detecting cancers, scans can also show evidence of damage to lungs (emphysema) and heart arteries (calcification). This study will test whether people can be encouraged to quit smoking by giving them pictures from their own scans showing possible lung and heart damage, along with information about how stopping smoking reduces their risk of cancer and heart attacks.


Options:
A: Prolonged Smoking Abstinence at End of 12 Weeks of Varenicline Treatment (12 weeks)
B: Rating of Urges to Smoke 24 Hours and One Week After the Target Quit Date Assessed by Mood and Physical Symptoms Scale (24 hours and 7 days after quit date (week 4))
C: 7-day point prevalent CO validated smoking cessation. (Three months after lung screening)
D: Change of ExpiredCO Level From Baseline (Weekly for 12 weeks); Level of Nicotine Dependence by Treatment Assignment (Weekly for 12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Adding a Personalised Smoking Cessation Intervention to a Lung Cancer Screening Programme
Brief Summary: Lung cancer rates are higher in Yorkshire than the rest of the UK, and this is due to higher rates of smoking. Deaths from lung cancer can be reduced using regular lung scans (screening) and by helping people stop smoking. As well as detecting cancers, scans can also show evidence of damage to lungs (emphysema) and heart arteries (calcification). This study will test whether people can be encouraged to quit smoking by giving them pictures from their own scans showing possible lung and heart damage, along with information about how stopping smoking reduces their risk of cancer and heart attacks.


Options:
A: Number of participants with 7-day point prevalence smoking abstinence (52 weeks)
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: Traditional smoking cessation rate (5 years); Change from baseline in the number of traditional cigarette smoked (6, 12, 24, 36 and 60 months.)
D: 7-day point prevalent CO validated smoking cessation. (Three months after lung screening)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Adding a Personalised Smoking Cessation Intervention to a Lung Cancer Screening Programme
Brief Summary: Lung cancer rates are higher in Yorkshire than the rest of the UK, and this is due to higher rates of smoking. Deaths from lung cancer can be reduced using regular lung scans (screening) and by helping people stop smoking. As well as detecting cancers, scans can also show evidence of damage to lungs (emphysema) and heart arteries (calcification). This study will test whether people can be encouraged to quit smoking by giving them pictures from their own scans showing possible lung and heart damage, along with information about how stopping smoking reduces their risk of cancer and heart attacks.


Options:
A: reducers (week-24 from baseline)
B: Number of Subjects With Four Week Continuous Quit Rate (CQR) (Week 9 through Week 12)
C: 7-day point prevalent CO validated smoking cessation. (Three months after lung screening)
D: Number of cigarettes smoked per day (End of 6 week intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Adding a Personalised Smoking Cessation Intervention to a Lung Cancer Screening Programme
Brief Summary: Lung cancer rates are higher in Yorkshire than the rest of the UK, and this is due to higher rates of smoking. Deaths from lung cancer can be reduced using regular lung scans (screening) and by helping people stop smoking. As well as detecting cancers, scans can also show evidence of damage to lungs (emphysema) and heart arteries (calcification). This study will test whether people can be encouraged to quit smoking by giving them pictures from their own scans showing possible lung and heart damage, along with information about how stopping smoking reduces their risk of cancer and heart attacks.


Options:
A: reducers (week-24 from baseline)
B: 7-day point prevalent CO validated smoking cessation. (Three months after lung screening)
C: Change in Biomarker Concentrations: Nicotine Equivalents (Baseline, Week 6); Change in Biomarker Concentrations: NNAL (Baseline, Week 6)
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: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Adding a Personalised Smoking Cessation Intervention to a Lung Cancer Screening Programme
Brief Summary: Lung cancer rates are higher in Yorkshire than the rest of the UK, and this is due to higher rates of smoking. Deaths from lung cancer can be reduced using regular lung scans (screening) and by helping people stop smoking. As well as detecting cancers, scans can also show evidence of damage to lungs (emphysema) and heart arteries (calcification). This study will test whether people can be encouraged to quit smoking by giving them pictures from their own scans showing possible lung and heart damage, along with information about how stopping smoking reduces their risk of cancer and heart attacks.


Options:
A: smoking cessation (52 weeks)
B: Toxicant Exposure (6 weeks)
C: 7-day point prevalent CO validated smoking cessation. (Three months after lung screening)
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: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Direct Selective Laser Trabeculoplasty (DSLT) In Open Angle Glaucoma (POAG): A Randomized Controlled Trial
Brief Summary: Glaucoma is an eye disease that results in damage to the optic nerve that progresses over time. One of the main risk factors in glaucoma is an increase in intraocular pressure, caused by a build-up of fluid in the eye. Glaucoma can result in blindness if left untreated and as such it is extremely important to diagnose and treat the condition.

Selective Laser Trabeculoplasty (SLT) is a laser treatment that facilitates the outflow of fluid from inside the eye. This has the potential of reducing the intraocular pressure within the eye (the main way in which this disease is treated since there is no cure) and may assist in helping to control the progression of this disease.

SLT (standard treatment) is a technique routinely carried out by glaucoma specialists. It is conducted using a special type of lens (goniolens) that gently sits on the front surface of the eye. The procedure takes approximately 5 minutes in duration.

This new treatment, Direct Selective Laser Trabeculoplasty (DSLT) is performed directly, without there being any need to use a goniolens which sits on the eye, and it is a shorter and simpler technique to conduct when compared to the standard SLT technique.

The purpose of this study is to assess the hypothesis that the treatment by new automated device for DSLT is not worse in comparison with the standard SLT and determine that it is effective in reducing intraocular pressure.


Options:
A: Change of circadian intraocular pressure (Six weeks after recieving treatment)
B: Intraocular pressure reduction
C: Intraocular Pressure (12 months post operatively)
D: The difference between the two treatment groups between the mean baseline IOP and the mean IOP after the treatment (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Human Controlled Infection Study to Establish a Safe, Reproducible and Practical Human Bordetella Pertussis Colonisation Model for the Identification of Correlates of Protection Against Colonisation (BPCCS)
Brief Summary: This is a prospective controlled human challenge study consisting of two phases; Phase A: Development of a B. pertussis human challenge model; pilot to establish the standard inoculum Phase B: Development of a modified B. pertussis human challenge model


Options:
A: Phase A - Inoculum Dose Determination (Up to volunteer visit Day 14)
B: Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) (1 month post-Dose 3)
C: kinetics of Pertussis toxin (PT) IgG titers in infants (from birth until 19 months of age); kinetics of Filamentous haemagglutinin (FHA) IgG titers in infants (from birth until 19 months of age); kinetics of Pertactin (Prn) IgG titers in infants (from birth until 19 months of age)
D: Diagnosis of IgE-mediated food allergy (birth-15 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating the Impact of Assessing During Peer Review the CONSORT Checklist Submitted by Authors: a Randomised Controlled Trial
Brief Summary: Randomised trials are considered the gold standard in medical research. The CONSORT (Consolidated Standards of Reporting Trials) Statement aims to improve the quality of reporting of randomised trials. Without transparent reporting, readers cannot judge the reliability and validity of trial findings, and therefore these findings cannot inform clinical practice. Different stakeholders, including biomedical journals, have taken different actions to try to improve author adherence to CONSORT. The most popular action among biomedical journals is to instruct authors to submit a completed RG checklist with page numbers indicating where the CONSORT items are addressed when they submit their manuscript. However, this measure alone has been proven not to be effective. In this study, the investigators intend to evaluate in a real editorial context whether assessing during peer review the consistency between the submitted CONSORT checklist and the information reported in the manuscripts of randomised trials, as well as to provide feedback to authors on the inconsistencies found, improves the completeness of reporting of published trials.


Options:
A: Overall completeness of reporting (Following manuscript revision (usually 2-3 months))
B: Completeness of reporting (Through study completion, an average of 1 year)
C: Completeness of reporting (Through study completion, an average of 1 year)
D: the mean number of items accurately classified per manuscript (through study completion, an average of 6 month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunological and Genomic Effects of an Online Mindfulness Program for Stress Management
Brief Summary: This is a prospective parallel non-blinded randomized study with two arms, an intervention group and an active control group.

Sixty healthy, but stressed nurses will be randomly assigned to either participate in a 6-week internet-based mindfulness meditation program produced by the Cleveland Clinic called Stress Free Now for Healers or to listen to relaxing music for at least 5 minutes a day for 6 weeks, and pre-post comparisons will be made for RNA expression profiles, plasma cytokine concentrations, telomerase activity, 6-point salivary cortisol and several self-reported assessments of physical and mental health.


Options:
A: Change in level of stress per Perceived Stress Scale (PSS) (Baseline and at 2 months (immediately post-intervention))
B: Pre-/post-intervention changes in mRNA transcript abundance across the entire transcriptome of circulating immune cells in the intervention group relative to the control group. (6 weeks); Pre-/post-intervention changes in IL-6 (6 weeks); Pre-/post-intervention changes in IL-8 (6 weeks); Pre-/post-intervention changes in IL-10 (6 weeks); Pre-/post-intervention changes in TNF-α (6 weeks); Pre-/post-intervention changes in IFN-γ (6 weeks); Pre-/post-intervention changes in peripheral blood mononuclear cell (PBMC) telomerase activity (6 weeks)
C: Change in Stress (baseline, 8wks (post-intervention),12-month follow-up)
D: Job satisfaction (baseline to 3 month)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunological and Genomic Effects of an Online Mindfulness Program for Stress Management
Brief Summary: This is a prospective parallel non-blinded randomized study with two arms, an intervention group and an active control group.

Sixty healthy, but stressed nurses will be randomly assigned to either participate in a 6-week internet-based mindfulness meditation program produced by the Cleveland Clinic called Stress Free Now for Healers or to listen to relaxing music for at least 5 minutes a day for 6 weeks, and pre-post comparisons will be made for RNA expression profiles, plasma cytokine concentrations, telomerase activity, 6-point salivary cortisol and several self-reported assessments of physical and mental health.


Options:
A: Pre-/post-intervention changes in mRNA transcript abundance across the entire transcriptome of circulating immune cells in the intervention group relative to the control group. (6 weeks); Pre-/post-intervention changes in IL-6 (6 weeks); Pre-/post-intervention changes in IL-8 (6 weeks); Pre-/post-intervention changes in IL-10 (6 weeks); Pre-/post-intervention changes in TNF-α (6 weeks); Pre-/post-intervention changes in IFN-γ (6 weeks); Pre-/post-intervention changes in peripheral blood mononuclear cell (PBMC) telomerase activity (6 weeks)
B: Change in executive function: National Institutes of Health Examiner battery (Baseline; post-intervention (9-10wk after baseline), 6 months follow-up.)
C: 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)
D: Stress Mindset Measure - General (SMM-G) (Change from Baseline SMM-G score at 6-months post CAR Training)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunological and Genomic Effects of an Online Mindfulness Program for Stress Management
Brief Summary: This is a prospective parallel non-blinded randomized study with two arms, an intervention group and an active control group.

Sixty healthy, but stressed nurses will be randomly assigned to either participate in a 6-week internet-based mindfulness meditation program produced by the Cleveland Clinic called Stress Free Now for Healers or to listen to relaxing music for at least 5 minutes a day for 6 weeks, and pre-post comparisons will be made for RNA expression profiles, plasma cytokine concentrations, telomerase activity, 6-point salivary cortisol and several self-reported assessments of physical and mental health.


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: Pre-/post-intervention changes in mRNA transcript abundance across the entire transcriptome of circulating immune cells in the intervention group relative to the control group. (6 weeks); Pre-/post-intervention changes in IL-6 (6 weeks); Pre-/post-intervention changes in IL-8 (6 weeks); Pre-/post-intervention changes in IL-10 (6 weeks); Pre-/post-intervention changes in TNF-α (6 weeks); Pre-/post-intervention changes in IFN-γ (6 weeks); Pre-/post-intervention changes in peripheral blood mononuclear cell (PBMC) telomerase activity (6 weeks)
C: Stress Mindset Measure - General (SMM-G) (Change from Baseline SMM-G score at 6-months post CAR Training)
D: Suicide Attempt Behavior (12-month observation period)

Answer: B