TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: UH3 Pragmatic Trial of Population-based Programs to Prevent Suicide Attempt
Brief Summary: This pragmatic clinical trial will evaluate the effectiveness of two population-based outreach programs for preventing suicide attempts among patients identified as at-risk. The study will be conducted at Kaiser Permanente (KP) Washington (the lead site) and at HealthPartners, KP Colorado and KP Northwest. Electronic health records will be used to identify outpatients aged 18 or older who respond to a routinely administered PHQ depression questionnaire by reporting thoughts of death or self-harm "most of the days" or "nearly every day". This trial will be limited to patients receiving care from one of the four participating health systems. Eligible patients will be automatically assigned to continue in usual care (1/3) or to either of the two intervention programs (1/3 each). Those assigned to usual care will not be contacted at all by study staff and will continue to receive usual care from treating primary care and mental health providers. Both intervention programs involve outreach by Epic secure messaging (with optional telephone outreach for those not reading messages). The Care Management intervention includes routine outreach to assess ongoing risk of suicide attempt and care management to monitor and facilitate ongoing engagement in outpatient follow-up. The Care Manager will coordinate care with treatment by primary and behavioral health care providers using Epic Staff Messaging (or telephone contacts if necessary). The Skills Training intervention uses an online skills training program to support patients in developing and using self-management skills for emotion regulation and crisis management. A Coach will monitor each participant's use of the program and send periodic messages (using Epic secure messaging) to encourage and support use of the program and practice of program skills. Each intervention continues for up to one year. In all three groups (Usual Care, Care Management, and Skills Training) virtual data warehouse data will be used to identify likely suicide attempts over 18 months following randomization. Analyses will compare risk of suicide attempt among all those randomized, regardless of response to the initial invitation or level of participation in the intervention programs. Comparison of all those randomized is the only scientifically valid method for assessing the overall impact of either program on population-level risk of suicide attempt.


Options:
A: Change in the Intensity of Suicidal Ideation Between Intake and End of Treatment (16 weeks (end of treatment)); Change in the Severity of Depression Symptoms Between Intake and End of Treatment (16 weeks (end of treatment))
B: Occurrence of suicidal event assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) (6 months)
C: Repeated fatal or non fatal suicidal act (one year)
D: Time to Fatal or Non-fatal Suicide Attempt or Self-Harm (18 Months after randomization)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Effectiveness of the Program of Mindfulness - Based Relapse Prevention (MBRP) as an Assistant Strategy to the Treatment of Tobacco Dependence
Brief Summary: The dependence on tobacco is a predictable leading cause of death. The treatment based on the cognitive-behavioral therapy, including relapse prevention, became standard for tobacco dependents; yet scientific advances are still needed. Accordingly, the Mindfulness-Based Relapse Prevention (MBRP) program, adjunct to treatment, has shown promising results. The purpose of this project is to evaluate the effectiveness of the program MBRP as an adjunct in the treatment of smoking cessation instituted by the Ministry of Health, through the Instituto Nacional do Câncer (INCA) in Brazil.There will be a randomized clinical trial, with a simple random allocation. 60 patients will participate in this study receiving treatment (INCA'S standard) randomized between two groups: the MBRP Group (EG), which will undergo eight sessions of MBRP; and the Control Group (CG) that will undergo eight sessions of the traditional model of Relapse Prevention.This study will be conducted at Ambulatory benchmark to smoking cessation treatment in the city of Juiz de Fora (Minas Gerais State- Brazil). Changes will be evaluated on several variables such as cessation of smoking, anxiety, depression, craving, positive and negative affects and will investigate the association of levels of mindfulness with smoking cessation. The data will be assessed at baseline (T0) and four other times: 1 (T1), 3 (T2), 6 (T3) and 12 months (T4) after the initiation of the study, besides being subjected to evaluations of regularly planned maintenance in the protocol of Ministry of Health. For data analysis there will be used Analysis of Variance with Repeated Measures and Longitudinal Logistic Regression, in order to evaluate the effect of two types of intervention on the evolution of comorbidities and abstinence of patients.


Options:
A: Smoking Abstinence (24 weeks post quit day)
B: Smoking behavior (6 months)
C: Self-report of not having smoked for the past 7 days (At 6th month after the initial intervention)
D: 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)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Effectiveness of the Program of Mindfulness - Based Relapse Prevention (MBRP) as an Assistant Strategy to the Treatment of Tobacco Dependence
Brief Summary: The dependence on tobacco is a predictable leading cause of death. The treatment based on the cognitive-behavioral therapy, including relapse prevention, became standard for tobacco dependents; yet scientific advances are still needed. Accordingly, the Mindfulness-Based Relapse Prevention (MBRP) program, adjunct to treatment, has shown promising results. The purpose of this project is to evaluate the effectiveness of the program MBRP as an adjunct in the treatment of smoking cessation instituted by the Ministry of Health, through the Instituto Nacional do Câncer (INCA) in Brazil.There will be a randomized clinical trial, with a simple random allocation. 60 patients will participate in this study receiving treatment (INCA'S standard) randomized between two groups: the MBRP Group (EG), which will undergo eight sessions of MBRP; and the Control Group (CG) that will undergo eight sessions of the traditional model of Relapse Prevention.This study will be conducted at Ambulatory benchmark to smoking cessation treatment in the city of Juiz de Fora (Minas Gerais State- Brazil). Changes will be evaluated on several variables such as cessation of smoking, anxiety, depression, craving, positive and negative affects and will investigate the association of levels of mindfulness with smoking cessation. The data will be assessed at baseline (T0) and four other times: 1 (T1), 3 (T2), 6 (T3) and 12 months (T4) after the initiation of the study, besides being subjected to evaluations of regularly planned maintenance in the protocol of Ministry of Health. For data analysis there will be used Analysis of Variance with Repeated Measures and Longitudinal Logistic Regression, in order to evaluate the effect of two types of intervention on the evolution of comorbidities and abstinence of patients.


Options:
A: 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)
B: Progression of albuminuria (1,2,3,4 and 5 year)
C: Change in impulsive eating (TFEQ-R18 "uncontrolled eating" subscale) (From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.)
D: Point prevalence abstinence at 6 months (6 months after beginning treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Effectiveness of the Program of Mindfulness - Based Relapse Prevention (MBRP) as an Assistant Strategy to the Treatment of Tobacco Dependence
Brief Summary: The dependence on tobacco is a predictable leading cause of death. The treatment based on the cognitive-behavioral therapy, including relapse prevention, became standard for tobacco dependents; yet scientific advances are still needed. Accordingly, the Mindfulness-Based Relapse Prevention (MBRP) program, adjunct to treatment, has shown promising results. The purpose of this project is to evaluate the effectiveness of the program MBRP as an adjunct in the treatment of smoking cessation instituted by the Ministry of Health, through the Instituto Nacional do Câncer (INCA) in Brazil.There will be a randomized clinical trial, with a simple random allocation. 60 patients will participate in this study receiving treatment (INCA'S standard) randomized between two groups: the MBRP Group (EG), which will undergo eight sessions of MBRP; and the Control Group (CG) that will undergo eight sessions of the traditional model of Relapse Prevention.This study will be conducted at Ambulatory benchmark to smoking cessation treatment in the city of Juiz de Fora (Minas Gerais State- Brazil). Changes will be evaluated on several variables such as cessation of smoking, anxiety, depression, craving, positive and negative affects and will investigate the association of levels of mindfulness with smoking cessation. The data will be assessed at baseline (T0) and four other times: 1 (T1), 3 (T2), 6 (T3) and 12 months (T4) after the initiation of the study, besides being subjected to evaluations of regularly planned maintenance in the protocol of Ministry of Health. For data analysis there will be used Analysis of Variance with Repeated Measures and Longitudinal Logistic Regression, in order to evaluate the effect of two types of intervention on the evolution of comorbidities and abstinence of patients.


Options:
A: Smoking Abstinence (End of Treatment (8 weeks))
B: 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)
C: Number of Participants With Smoking Abstinence (4 weeks post quit day (one week following the end of treatment)); Smoking Abstinence (26 weeks post quit day); Smoking Abstinence (4 weeks post quit day (one week following the end of treatment))
D: 30-day point prevalence abstinence (12 month post randomization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of Repeated Allergen Challenge and the Effects of Ibuprofen on the Inflammatory Process
Brief Summary: The study will assess airway responses in mild atopic asthmatics undergoing repeat allergen challenge testing and will investigate whether ibuprofen changes the response.


Options:
A: Change in Percentage of participants using controller medications for asthma from baseline to 12 month follow-up (Baseline, 12)
B: Safety and toxicity profile: Unacceptable Serious Adverse Events (6 weeks (up to 12 weeks))
C: FEV1 peak0-3 Change From Baseline (Baseline and 24 weeks)
D: Airway response to inhaled allergen (at time of allergen inhalation challenge and for 7 hours after)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevenção do Diabetes em Mulheres Com Diabetes Gestacional prévio: Estudo multicêntrico de mudanças Intensivas de Estilo de Vida: LINDA-Brasil
Brief Summary: Randomized trial aiming to investigate the effectiveness of a lifestyle intervention program implemented within the first year after a pregnancy complicated by gestational diabetes (GDM), in delaying or preventing the development of type 2 diabetes.


Options:
A: Incident diabetes mellitus (Up to 5 years)
B: Diabetes Incidence (Baseline through end of follow-up (mean follow-up time = 3 years))
C: Change in weight from baseline (12- and 24-months)
D: Fasting Glucose (Change from Baseline at 6, 12, 18, 24, 36, 42, 48, 54, 60, 66, 72 and 78 months from randomization)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Physical Activity for Older Adults With Chronic Low Back Pain: PACe-LBP
Brief Summary: Chronic low back pain (cLBP) is one of the most common and disabling conditions among US military Veterans. Although physical activity can improve cLBP outcomes, the majority of Veterans with cLBP are inactive. Therefore the VA is in need of effective programs that can help older Veterans with cLBP to increase their physical activity and improve associated outcomes. This is particularly relevant for older Veterans with cLBP who are at greater risk for functional limitations. The proposed project will be a pilot study of a telephone-based physical activity program or physical activity combined with cognitive behavioral pain management for older adult Veterans with cLBP. Older Veterans are of particular interest because prior studies of physical activity for cLBP have not addressed this vulnerable patient group. This study will also inform the VA about whether certain patients with cLBP, who have greater pain sensitivity, may benefit from other treatment to supplement a physical activity program.


Options:
A: Pain Scores (Baseline, Midtreatment, Posttreatment, 3 month follow-up, 6 month follow-up)
B: Timed Get-Up-And Go (Change from baseline to 12-week follow-up); PROMIS Health Assessment Questionnaire (Change from baseline to 12-week follow-up)
C: Pain Intensity (2 months after randomisation); Disability (2 months after randomisation)
D: Sickness absence days (Low back (LB) specific, other than LB, total) (6, 12, 24, 36, 48 months); Low back pain (VAS) (0, 3, 6, 12, 24 months); Disability (Roland Morris 18) (0, 3, 6, 12, 24 months); Quality of Life (15-D) (0, 3, 6, 12, 24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of a Mindfulness Intervention for Labor-Related Pain and Fear
Brief Summary: The purpose of this small randomized controlled trial (RCT) is to compare the impact of a brief (16 hour) 3rd trimester mindfulness-based childbirth education program, "Mind in Labor (MIL): Working with Pain in Childbirth," with a standard care/"treatment as usual" (TAU) active control condition of standard hospital- and community-based childbirth education. The MIL group is expected to demonstrate a reduction in fear of labor (less pain catastrophizing and greater childbirth self-efficacy), less perceived pain in labor, less use of pain medication in labor, greater birth satisfaction, and better prenatal and postpartum psychological adjustment compared to the TAU group.


Options:
A: Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ-A) (Change from the Wijma Delivery Expectancy/Experience Questionnaire Version A scores at pre-education and post-education (4 weeks later).); Childbirth Self-Efficacy Inventory (CBSEI) (Change from the Childbirth Self-efficacy Inventory scores at pre-education and post-education (4 weeks later).); The depression anxiety and stress scale (DASS-21) (Change from the Depression Anxiety and Stress Scale scores at pre- education, post-education (4 weeks later) and postpartum 6-8 weeks.); The Wijma Delivery Expectancy/Experience Questionnaire B version (W-DEQ-B) (Change from The Wijma Delivery Expectancy/Experience Questionnaire B version (W-DEQ-B) scores at postpartum 6-8 weeks.)
B: Fear of childbirth (pregnancy 12-24 weeks); Fear of childbirth (pregnancy 32-36 weeks); Fear of childbirth (postpartum 1 week)
C: Change in Fear of labor (childbirth self-efficacy and pain catastrophizing) (Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth)); Perceived labor pain (Postpartum (average of 6 weeks post-birth)); Pain medication use during labor (Labor (during childbirth)); Childbirth satisfaction (Postpartum (average of 6 weeks post-birth)); Change in Depression (Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth); Postpartum (average of 6 weeks postbirth); Follow-up (1-2 years post-birth))
D: The use of epidural analgesia during birth (At birth)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Study on the Psychological Behavior Intervention Technology of Attention Deficit Hyperactivity Disorder
Brief Summary: ADHD children have executive function (EF) impairments,so we randomize the children to the training or a waitlist to improve EF ,adding contingent reinforcement to ascertain whether EF deficits are amenable to the training in children with ADHD.


Options:
A: N/A
B: ADHD core symptoms: measured by Conners 3 index: 'Hyperactivity- Impulsivity Scale' (teacher rated.) (3 month); ADHD core symptoms: measured by Conners 3 index: 'Hyperactivity- Impulsivity Scale' (teacher rated.) (6 month)
C: change in ADHD-rating scale (baseline,after the training (12week))
D: Rule Violations During Direct Classroom Observation at Endpoint (Week 8) (Endpoint (Week 8))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical & Visual Outcomes of Collagen Cross Linking for Fungal Keratitis
Brief Summary: The study is a randomised control trial to assess the visual and clinical outcomes of collagen cross linking in fungal keratitis. Fungal keratitis is a major cause of corneal blindness in India and the therapeutic options available are minimal to handle the advanced complications and sequalae caused by the disease.The antimicrobial and tissue remodeling role of corneal cross linking was demonstrated by several studies earlier,we anted to specifically assess the role of corneal cross linking in non resolving fungal keratitis in prevention of perforation and enhancement of healing process.


Options:
A: size of infiltrate or scar, corneal structural integrity (6 months)
B: time of complete healing (days) (180 days)
C: Clinical stabilisation of keratoconus one year after CXL (1 year)
D: Time to Re-epithelialization (Day 1, day 2, day 3, day 4, day 5, day 6, day 7, week 2, and subsequent weekly assessments until re-epithelialization is complete)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial to Reduce Harm From Tobacco
Brief Summary: Using the NIH-funded Way to Health platform, the investigators will conduct this smoking cessation RCT among Vitality/Discovery beneficiaries. The investigators will be able to determine the effectiveness of 4 different interventions aimed at smoking cessation, two of which are incentive structures that are each grounded in behavioral economic principles. The other interventions will determine the effectiveness of various cessation aids, including electronic cigarettes and text messaging, on smoking cessation. This study will be conducted as an opt-out procedure where participants are automatically enrolled in the program but have the choice to unenroll if they so chose. This pragmatic approach will allow us to investigate the effects of such programs in an employee based population that can be easily mimicked in other employee based populations.


Options:
A: Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers. (3 months); Point Prevalence Abstinence at 3 Months. (3 months)
B: verified abstinence 6 months (6 months)
C: To assess the continuous abstinence from tobacco smoking at every visit during the last 4 weeks of treatment period, i.e. from week 4 to week 7, through direct inquiry of patients, exhaled carbon monoxide (CO) testing, and plasma cotinine measurements
D: effectiveness (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial to Reduce Harm From Tobacco
Brief Summary: Using the NIH-funded Way to Health platform, the investigators will conduct this smoking cessation RCT among Vitality/Discovery beneficiaries. The investigators will be able to determine the effectiveness of 4 different interventions aimed at smoking cessation, two of which are incentive structures that are each grounded in behavioral economic principles. The other interventions will determine the effectiveness of various cessation aids, including electronic cigarettes and text messaging, on smoking cessation. This study will be conducted as an opt-out procedure where participants are automatically enrolled in the program but have the choice to unenroll if they so chose. This pragmatic approach will allow us to investigate the effects of such programs in an employee based population that can be easily mimicked in other employee based populations.


Options:
A: verified abstinence 6 months (6 months)
B: urine carcinogen biomarker of exposure, NNAL (week 24)
C: Endothelial dysfunction (up to 24 weeks); Oxidative stress (up to 24 weeks)
D: Change in Weight (Baseline, 3 months, 6 months, 9 months, 12 months and 1 year post program follow up); Change in the 6 minute walk test (Baseline, 3 months, 6 monhts, 9 months, 12 months, and 1 year post program completion follow up); Change in Days of Abstinence-Timeline follow back interview for tobacco smokers (Baseline, 3 months, 6 months, 9 months, 12 months, and 1 year post program completion follow up); Change in Carbon Monoxide Level (Baseline, 3 months, 6 months, 9 months, 12 months, and 1 year post program completion follow up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial to Reduce Harm From Tobacco
Brief Summary: Using the NIH-funded Way to Health platform, the investigators will conduct this smoking cessation RCT among Vitality/Discovery beneficiaries. The investigators will be able to determine the effectiveness of 4 different interventions aimed at smoking cessation, two of which are incentive structures that are each grounded in behavioral economic principles. The other interventions will determine the effectiveness of various cessation aids, including electronic cigarettes and text messaging, on smoking cessation. This study will be conducted as an opt-out procedure where participants are automatically enrolled in the program but have the choice to unenroll if they so chose. This pragmatic approach will allow us to investigate the effects of such programs in an employee based population that can be easily mimicked in other employee based populations.


Options:
A: Smoking Abstinence - Serum/Urine Measurements (Week 12); Smoking Abstinence - Number of Cigarettes Smoked (Week 12); Smoking Abstinence - Exhaled Carbon Monoxide (Week 12)
B: To Determine the Safety of Varenicline in PLWH Who Smoke (3 months)
C: verified abstinence 6 months (6 months)
D: Toxicant Exposure (6 weeks)

Answer: C