TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancement of Presence, Compassion and Resilience Bringing the Practice of Mindfulness Into Nature - Preventing Mental Fatigue in Healthcare Professionals.
Brief Summary: The purpose of the study is to determine whether a five day mindfulness retreat in nature can increase measures of attention and self-compassion, and reduce stress among bachelor students at Danish Universities and University Colleges. Secondary whether the expression of inflammatory markers can be reduced .

It is the hypothesis that perceived stress is reduced and the expression of genetic markers of inflammation is reduced after a five day mindfulness retreat.


Options:
A: The primary aim of the study is to evaluate the effectiveness of problem-solving training provided to mothers of children with newly diagnosed cancer in decreasing negative affectivity; e.g. depression, anxiety, and increasing satisfaction with resource utilization
B: Perceived Stress Scale (At the end of five days retreat); Self-compassion (At the end of five days retreat)
C: Change from baseline Perceived Stress Scale (PSS) score at 4, 8 weeks (Baseline and after 4, 8 weeks later)
D: Return to work (at 6, 12, 24 and 60 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancement of Presence, Compassion and Resilience Bringing the Practice of Mindfulness Into Nature - Preventing Mental Fatigue in Healthcare Professionals.
Brief Summary: The purpose of the study is to determine whether a five day mindfulness retreat in nature can increase measures of attention and self-compassion, and reduce stress among bachelor students at Danish Universities and University Colleges. Secondary whether the expression of inflammatory markers can be reduced .

It is the hypothesis that perceived stress is reduced and the expression of genetic markers of inflammation is reduced after a five day mindfulness retreat.


Options:
A: Perceived Stress Scale (At the end of five days retreat); Self-compassion (At the end of five days retreat)
B: 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.)
C: Change in Stress (baseline, 8wks (post-intervention),12-month follow-up)
D: 30-day Point Prevalence Abstinence, Complete-case (12 months post randomization)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Self-Monitoring Assessment in Real Time: 2-SMART
Brief Summary: The purpose of the study is to test the effectiveness of two different methods of mobile dietary self-monitoring for weight loss. Both of these interventions will provide weight loss information through twice weekly audio podcasts. In addition to the podcasts, participants will be asked to track their diet using an assigned mobile applications (for their smartphone), which will be randomly assigned.


Options:
A: Change in Weight (Baseline, 1 month, 3 months)
B: Body Mass Index (BMI) (baseline and 6 months)
C: Number of days diet is self-monitored (6 months)
D: Weight change (Baseline, 6, 12, and 24 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Integrating Behavioral Health and Primary Care for Comorbid Behavioral and Medical Problems
Brief Summary: Behavioral problems are part of many of the chronic diseases that cause the majority of illness, disability and death. Tobacco, diet, physical inactivity, alcohol, drug abuse, failure to take treatment, sleep problems, anxiety, depression, and stress are major issues, especially when chronic medical problems such as heart disease, lung disease, diabetes, or kidney disease are also present. These behavioral problems can often be helped, but the current health care system doesn't do a good job of getting the right care to these patients.

Behavioral health includes mental health care, substance abuse care, health behavior change, and attention to family and other psychological and social factors. Many people with behavioral health needs present to primary care and may be referred to mental health or substance abuse specialists, but this method is often unacceptable to patients. Two newer ways have been proposed for helping these patients. In co-location, a behavioral health clinician (such as a Psychologist or Social Worker) is located in or near the primary practice to increase the chance that the patient will make it to treatment. In Integrated Behavioral Health (IBH), a Behavioral Health Clinician is specially trained to work closely with the medical provider as a full member of the primary treatment team.

The research question is: Does increased integration of evidence-supported behavioral health and primary care services, compared to simple co-location of providers, improve outcomes? The key decision affected by the research is at the practice level: whether and how to use behavioral health services.

The investigators plan to do a randomized, parallel group clustered study of 3,000 subjects in 40 practices with co-located behavioral health services. Practices randomized to the active intervention will convert to IBH using a practice improvement method that has helped in other settings. The investigators will measure the health status of patients in each practice before and after they start using IBH. The investigators will compare the change in those outcomes to health status changes of patients in practices who have not yet started using IBH.

The investigators plan to study adults who have both medical and behavioral problems, and get their care in Family Medicine clinics, General Internal Medicine practices, and Community Health Centers.


Options:
A: COPD Assessment Test (CAT) (Baseline and 6 months)
B: Changes in COPD-patients self reported-health, their evaluation of the health system and in the distribution of health resources. (14 months)
C: The proportion of elderly patients hospitalized with the J-44 code as a main reason for admission after interventions vs. control. (12 months)
D: PROMIS-29 v2 (24 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Acceptability, Feasibility, and Impact of Telelactation Among Rural Mothers
Brief Summary: The investigators will conduct a randomized controlled trial (RCT) to generate data on the impact of direct-to-consumer "telelactation" (virtual breastfeeding support) services. We will explore the feasibility, acceptability, and impact of these services. Postpartum mothers age 18 and older who have initiated breastfeeding will be recruited at a critical access hospital without access to IBCLCs in rural Pennsylvania and randomized into two study arms: 1) outpatient telelactation services via video calls on personal devices or 2) usual care. Data on breastfeeding duration and exclusivity, as well as perceptions and satisfaction with breastfeeding, will be captured via surveys and in-depth interviews and compared across groups.


Options:
A: Any breastfeeding (yes/no) at 3 months (Three months); Exclusive breastfeeding (yes/no) at 3 months (Three months)
B: Study the effect of a standard two-encounter postnatal lactation counseling protocol on the initiation and maintenance of exclusive breastfeeding in mothers
C: Change in Length-for-age Z scores (LAZ) at 3, 6, 12, 18 and 24 months age of children in intervention vs. comparison arms, compared to the baseline LAZ at 7 days of birth. (1, 3, 6, 9, 12, 15, 18, 21 and 24 months of child's age)
D: Exclusive breastfeeding rate at 6 months postpartum (6 months postpartum); Full breastfeeding rate at 6 months postpartum (6 months postpartum)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Bladder Directed and Pelvic Floor Therapy in Women with Interstitial Cystitis/Bladder Pain Syndrome
Brief Summary: Women with interstitial cystitis/bladder pain syndrome (IC/BPS) have debilitating urinary frequency and urgency, and chronic pelvic or bladder pain perceived to be related to the bladder. Although many clinicians think that IC/BPS symptoms result from a bladder problem, tight pelvic floor muscles can cause similar symptoms and might be responsible for ICBPS symptoms instead of the bladder. Inadequate assessment of the problem leads to delays in treatment and often years of suffering. This clinical trial will test a bladder directed therapy (bladder instillations) compared to a course of pelvic floor physical therapy (PFPT) to assess the role of the pelvic floor as a major contributor to pelvic pain and voiding dysfunction in adult women with non-ulcerative IC/BPS. Early assessment of the pelvic floor muscles in patients with IC/BPS symptoms may prevent common delays in proper diagnosis and allow for early, more effective treatment.


Options:
A: Change From Baseline in Treatment Response as Measured by the Total Score on the O'Leary-Sant Questionnaire (Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported)
B: Pain reduction or resolution within 10 treatment sessions, evaluated with the 0-10 Numeric Pain Rating Scale (0-10NPRS) (10 weeks or earlier on resolution)
C: Markedly/Moderately Improved on Global Response Assessments (Week 9 (one week after last treatment))
D: Change from baseline in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score. (12 WEEKS); Change from baseline in worst daily pain severity score as measured by an 11-point Numerical Rating Scale (NRS). (12 WEEKS)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Dose-ranging, Parallel-group Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BCX7353 as a Preventative Treatment to Reduce the Frequency of Attacks in Subjects With Hereditary Angioedema
Brief Summary: This 3-part study will evaluate the safety and efficacy of an oral treatment, BCX7353, in preventing angioedema attacks in subjects with hereditary angioedema (HAE). In Part 1 of the study, eligible subjects will be randomized to receive oral BCX7353 or placebo for 4 weeks. Assuming successful completion of Part 1, additional subjects will be randomized in Part 2 to one of 2 lower doses of BCX7353 or placebo. Part 3 will enroll additional subjects into one of three doses of BCX7353 or placebo. The study will compare the number of acute attacks in each treatment group, as well as a number of other clinical and pharmacologic outcomes, and the safety and tolerability of each dose of BCX7353 compared to placebo.


Options:
A: The Mean Time Normalized Number of HAE Attacks Per Month in Subjects With C1-INH HAE During Treatment Period 1 (13 weeks)
B: Normalized Number of Angioedema Attacks During the Treatment Period (From Visit 1 (Week 1) up to Visit 16 (Week 8) during each treatment period)
C: Number of HAE Attacks (28 days)
D: Number of Confirmed HAE Attacks (Investigators collected data from patient diaries from the first day of dosing through to Day 29 or last day of dosing +24 hrs (the effective dosing period).); Proportion of Subjects Who Were HAE Attack-free During the Entire Dosing Period (Investigators collected data from patient diaries from the first day of dosing through to Day 29 or last day of dosing +24 hrs (the effective dosing period).)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of a Peer-led Walking In ScHools Intervention on Physical Activity Levels of Adolescent Girls: a School-based Cluster Randomised Controlled Trial
Brief Summary: Children and young people are recommended to undertake at least 60 minutes of moderate to vigorous intensity physical activity each day. However recent findings have indicated that only 51% of children aged 7 years were meeting these guidelines. Previous research has also highlighted girls are significantly less active than. Furthermore, children living in Northern Ireland are least likely to meet the guidelines, with only 43.4% of children here reaching the recommended ≥ 60 minutes a day. The development of interventions which can successfully increase levels of physical activity in adolescent girls in Northern Ireland is of key importance. The aim of this intervention is to investigate whether or not girls (aged 11-13 years) can increase their daily levels of physical activity over a 12 week period by taking part in a school-based brisk walking intervention. The impact of participating in a school-based brisk walking intervention on a range of other outcome measures will also be investigated. A total sample of 200 adolescent females will be recruited onto the study, with recruitment of participants taking place at the school level. Following written consent from parents/guardians and assent from participants, participants will be randomised at the school level to either participate in the walking intervention or to act as controls. Objective physical activity will be assessed at 3 time points using an Actigraph accelerometer. At baseline, post-intervention (12 weeks) and follow up (4 months post-intervention) participants will also undergo measurements of height, weight, waist and hip circumference, bloody pressure, and cardiorespiratory fitness. Participants will also complete questionnaires assessing levels of physical activity and a number of psychosocial variables at each time point. Following completion of follow up measurements, a sub-sample of participants (n=45) will be invited to take part in focus groups to evaluate their experiences of the intervention.


Options:
A: Weight in Kilograms (Baseline, 12 weeks); Weight z Score (Baseline, 12 weeks); BMI Calculated as "Weight (kg) / Height (m^2)" (Baseline, 12 weeks); BMI z Score (Baseline, 12 weeks); Body Fat Percentage as Determined by Siri Formula From Skinfold Thicknesses (Baseline, 12 weeks)
B: Total daily physical activity (Change between baseline and post-intervention (12 weeks) and 4-months post-intervention)
C: Change from baseline in physical activity as assessed by Actigraph accelerometer (Baseline, 6 months and 1 year)
D: Moderate-to-vigorous physical activity (MVPA) time during activity breaks (Year 3)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of a Peer-led Walking In ScHools Intervention on Physical Activity Levels of Adolescent Girls: a School-based Cluster Randomised Controlled Trial
Brief Summary: Children and young people are recommended to undertake at least 60 minutes of moderate to vigorous intensity physical activity each day. However recent findings have indicated that only 51% of children aged 7 years were meeting these guidelines. Previous research has also highlighted girls are significantly less active than. Furthermore, children living in Northern Ireland are least likely to meet the guidelines, with only 43.4% of children here reaching the recommended ≥ 60 minutes a day. The development of interventions which can successfully increase levels of physical activity in adolescent girls in Northern Ireland is of key importance. The aim of this intervention is to investigate whether or not girls (aged 11-13 years) can increase their daily levels of physical activity over a 12 week period by taking part in a school-based brisk walking intervention. The impact of participating in a school-based brisk walking intervention on a range of other outcome measures will also be investigated. A total sample of 200 adolescent females will be recruited onto the study, with recruitment of participants taking place at the school level. Following written consent from parents/guardians and assent from participants, participants will be randomised at the school level to either participate in the walking intervention or to act as controls. Objective physical activity will be assessed at 3 time points using an Actigraph accelerometer. At baseline, post-intervention (12 weeks) and follow up (4 months post-intervention) participants will also undergo measurements of height, weight, waist and hip circumference, bloody pressure, and cardiorespiratory fitness. Participants will also complete questionnaires assessing levels of physical activity and a number of psychosocial variables at each time point. Following completion of follow up measurements, a sub-sample of participants (n=45) will be invited to take part in focus groups to evaluate their experiences of the intervention.


Options:
A: BMI (6 months)
B: Change in Stress (3 months); Change in Stress (1 month)
C: Total daily physical activity (Change between baseline and post-intervention (12 weeks) and 4-months post-intervention)
D: Change in Body Mass Index (Baseline, 2, 4, 6, 8, 10, 12, 14, 16, 18, 24 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Integrated Mental Health Care and Vocational Rehabilitation to Individuals on Sick Leave Due to Anxiety and Depression in Denmark (the Danish IBBIS Study): A Multi-center Randomized Controlled Trial
Brief Summary: The purpose of this study is to investigate the efficacy of 1) a stepped mental health care intervention and 2) an integrated mental health care and vocational rehabilitation intervention for people on sick leave because of depression and anxiety in Denmark


Options:
A: N/A
B: Time to return to work (12 months)
C: Change from baseline Hamilton Rating Scale for Depression at 12 months (12 months)
D: HAM-D17 (Before and after 3 months intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Does the Wording of Text Message Reminders Improve Uptake in Breast Screening? A Randomised Controlled Trial
Brief Summary: Breast screening is a service offered by the NHS to help detect breast cancer and precancerous changes early at a time when treatment is more likely to be curative. An effective service must reach the 'at risk' but asymptomatic population. Breast screening uptake in London, consistently falls below the national target and is well below the national average. Uptake in West London is particularly low, with boroughs in Inner North West London having the some of lowest uptake rates in the country.

Routine text message reminders have proven effective at improving uptake of breast screening appointments. However little attention is paid to the content of the messages. Previous studies of text message reminders in other clinical areas have shown that the content of these messages matters and some text messages are more effective than others.

This protocol describes the design of a randomized controlled trial to investigate the effect of differently worded text messages on the engagement with breast screening in West London.

Two intervention arms were designed taking into consideration results of a 1000 woman survey to highlight the behavioural barriers that most predict attendance. The survey tested 15 behavioural constructs and the two that most strongly predicted history of attendance were used to inform the text message content of the intervention arms for this trial.

To this end, this randomised controlled trial (RCT) will test the current standard practice text message reminder against two intervention text message trial arms informed by the above described survey.

The setting is West of London Breast Screening Service and women aged 47-73 who are due for screening will be randomized to receive one of the three trial arms.

The primary outcome is the difference in uptake between trial arms. Further statistical analysis will analyse the difference in uptake by age group, deprivation score and previous attendance status.

Result will inform how small changes to the word content may have significant effects on attendance at screening mammogram appointments.


Options:
A: Uptake of the timed appointment provided by the screening service (Usually within a month (Individual timed appointment is provided by the screening service))
B: Rate of Enrollment (Month 12); Acceptability of the mHealth application (Month 12)
C: Differences in the Screen IVF questionaire between the intervention groups (through study completion, an average of 2 years)
D: Clinic attendance for pills pick up (six months.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Does the Wording of Text Message Reminders Improve Uptake in Breast Screening? A Randomised Controlled Trial
Brief Summary: Breast screening is a service offered by the NHS to help detect breast cancer and precancerous changes early at a time when treatment is more likely to be curative. An effective service must reach the 'at risk' but asymptomatic population. Breast screening uptake in London, consistently falls below the national target and is well below the national average. Uptake in West London is particularly low, with boroughs in Inner North West London having the some of lowest uptake rates in the country.

Routine text message reminders have proven effective at improving uptake of breast screening appointments. However little attention is paid to the content of the messages. Previous studies of text message reminders in other clinical areas have shown that the content of these messages matters and some text messages are more effective than others.

This protocol describes the design of a randomized controlled trial to investigate the effect of differently worded text messages on the engagement with breast screening in West London.

Two intervention arms were designed taking into consideration results of a 1000 woman survey to highlight the behavioural barriers that most predict attendance. The survey tested 15 behavioural constructs and the two that most strongly predicted history of attendance were used to inform the text message content of the intervention arms for this trial.

To this end, this randomised controlled trial (RCT) will test the current standard practice text message reminder against two intervention text message trial arms informed by the above described survey.

The setting is West of London Breast Screening Service and women aged 47-73 who are due for screening will be randomized to receive one of the three trial arms.

The primary outcome is the difference in uptake between trial arms. Further statistical analysis will analyse the difference in uptake by age group, deprivation score and previous attendance status.

Result will inform how small changes to the word content may have significant effects on attendance at screening mammogram appointments.


Options:
A: Uptake of the timed appointment provided by the screening service (Usually within a month (Individual timed appointment is provided by the screening service))
B: Differences in the Screen IVF questionaire between the intervention groups (through study completion, an average of 2 years)
C: Rate of Premature birth (before 37 weeks gestation)
D: Exclusive breastfeeding duration (Six months)

Answer: A