TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Controlled, 2-arm Parallel Group, Multi-center Study, to Evaluate Biological and Functional Changes in Healthy Smokers Switching to Tobacco Heating System 2.2 (THS 2.2) Compared to Continuing Smoking Conventional Cigarettes for 26 Weeks in an Ambulatory Setting
Brief Summary: The aim of the study is to demonstrate clinical, biological and functional health changes in smokers switching to the candidate modified risk tobacco product: Tobacco Heating System 2.2 (THS 2.2) as compared to smokers continuing smoking their conventional cigarettes (CC) over a 26-week period.

To characterize the study as successful, at least 5 clinical risk endpoints should move in the direction of smoking cessation and these results would be statistically significant. The main analysis will be defined a priori (using the Hailperin-Ruger approach) and will be made between THS 2.2 use and CC use as "per actual product used" and product use categories.


Options:
A: Levels of High Density Lipoprotein C (HDL-C). (26 Weeks); Levels of White Blood Cells (WBC). (26 Weeks); Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1). (26 Weeks); Concentrations of Soluble Intercellular Adhesion Molecule 1 (sICAM-1). (26 Weeks); Concentrations of 11-dehydrothromboxane B2 (11-DTXB2). (26 Weeks); Concentrations of 8-epi-prostaglandin F2α (8-epi-PGF2α). (26 Weeks); Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL). (26 Weeks); Percent Change From Baseline of Carboxyhemoglobin (COHb) (26 Weeks)
B: Concentration of Monohydroxybutenylmercapturic Acid (MHBMA) (5 days); Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA) (5 days); Concentration of S-phenylmercapturic Acid (S-PMA) (5 days); Levels of Total 4-(Methylnitrosamino)-1-(3- Pyridyl)-1-butanol (Total NNAL) (90 days); Levels of Carboxyhemoglobin (COHb) (5 days)
C: Number of Participants With Smoking Cessation (12 WEEK)
D: Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA) (5 days); Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA) (5 days); Concentration of S-phenylmercapturic Acid (S-PMA) (5 days); Levels of Carboxyhemoglobin (COHb) (5 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Using Telehealth to Deliver Mental Health Services in Primary Care Settings for Children in Underserved Areas
Brief Summary: In partnership with a multi-site, Los Angeles-area community clinic consortium, North East Valley Health Corporation (NEVHC), the investigators will use telehealth to integrate pediatric developmental, behavioral and mental health (DB/MH) services into primary care for low-income, publicly insured children. During Project Year 1, the investigators used qualitative methods to conduct and analyze interviews with parents, clinicians, and staff at NEVHC to assess their perspectives on the delivery of child DB/MH services and on a potential telehealth-based patient visit, coordination, and clinician education system for the provision of DB/MH specialty care in primary care settings to children ages 5-12. This data was used in a stakeholder-engaged process to customize a telehealth-based delivery system for pediatric DB/MH services that can be integrated into primary care settings.

During Project Years 2-3, the investigators will conduct a cluster randomized controlled trial (RCT) to compare the customized telehealth-based patient visit, coordination, and clinician education system to the usual in-person, community- based referral system at NEVHC. This study will examine whether a telehealth developmental, behavioral and mental health delivery model can be an effective, efficient, and family-centered way to provide integrated DB/MH services to children in low-income communities.


Options:
A: Child BMI (3 years)
B: glycosylated hemoglobin (36 months)
C: Access to specialty services- Referral time (6 month post-enrollment); Access to specialty services- Travel (6 month post-enrollment); Access to specialty services- Missed school/work (6 month post enrollment); Access to specialty services- Out of pocket cost (6 month post-enrollment); Access to specialty services- Visits (6 month post-enrollment)
D: Practice-level colon cancer screening rate (12-months post baseline)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: miPlan: A Randomized Controlled Trial of miPlan Intervention vs. Standard of Care
Brief Summary: Using our experience in digital media, behavior theory, client-centered interventions, and family planning, we have prototyped a digital application ("app")-miPlan-to be used in the clinic waiting room prior to a contraceptive visit. The goal of this research is to refine the app and conduct a randomized controlled trial of the miPlan intervention vs. standard care. The aim of this study is to understand miPlan's impact. The primary outcome is LARC uptake at clinic discharge. The secondary outcomes are contraceptive use at discharge, self-efficacy and decisional balance for highly effective contraception post-app use, contraceptive satisfaction, and intention to continue method use. The research will consist of baseline activities as well as a three-month follow-up call.


Options:
A: Differences in the Screen IVF questionaire between the intervention groups (through study completion, an average of 2 years)
B: Highly-effective contraceptive use (6 months postpartum)
C: Smoking status by collecting an expired carbon monoxide breath sample (3-Month Follow-Up)
D: LARC uptake (at time of intervention (baseline (0 weeks))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Intervention of HIV, Drug Use and the Criminal Justice System in Malaysia
Brief Summary: The purpose of this study is to evaluate the relative impact a medical drug (methadone) or behavioral counseling program (Holistic Health Recovery Program) or both (methadone and Holistic Health Recovery Program) has on reducing HIV-related risk behaviors and illicit drug use among opioid-dependent, HIV-infected individuals in prison when given 90 to 180 days prior to leaving prison.


Options:
A: Illicit opioid abstinence (12 weeks)
B: HIV Risk Events (Change from Baseline in HIV Risk Events at Months 3, 6, 9 and 12)
C: Number of biological samples negative/positive for opioid agonists (Week 1-12 post discharge); Retention (Week 1-12 post discharge); Days of use or abstinence from opioids (Week 1-12 post discharge)
D: Opiate abstinence

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Active-controlled, Clinical Trial Comparing Effects of Mindfulness and Interpersonal Effectiveness Skills in Borderline Personality Disorder
Brief Summary: The purpose of the study was to determine whether mindfulness training could be more effective than another active intervention in reducing borderline personality disorder (BPD) symptoms. The main hypothesis was that patients allocated to the mindfulness group would show a greater improvement on global BPD symptomatology. As a second objective, we explored some of the possible underlying mechanisms of both active treatments. For that purpose, changes in decentering, mindfulness facets and cognitive processing of social interactions were also evaluated.


Options:
A: Self-harm as measured by the self-harm sub scale of the Risk-taking and Self-harm Inventory for Adolescents (Vrouva et al, 2010) (12 weeks); Self-harm and related hospital use as reported in National Health Service patient records (12 weeks)
B: Suicidal thoughts or attempts (Measured at Year 2)
C: change from baseline in borderline symptoms after a 10 week intervention (10 weeks)
D: The Zanarini Rating Scale for Borderline Personality Disorder (Weeks 0, 2, 4, 6, 8, 10, 12); Borderline Evaluation of Severity over Time (BEST) (Weeks 0,2,4,6,8,10,12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Active-controlled, Clinical Trial Comparing Effects of Mindfulness and Interpersonal Effectiveness Skills in Borderline Personality Disorder
Brief Summary: The purpose of the study was to determine whether mindfulness training could be more effective than another active intervention in reducing borderline personality disorder (BPD) symptoms. The main hypothesis was that patients allocated to the mindfulness group would show a greater improvement on global BPD symptomatology. As a second objective, we explored some of the possible underlying mechanisms of both active treatments. For that purpose, changes in decentering, mindfulness facets and cognitive processing of social interactions were also evaluated.


Options:
A: MHS heavy use (2 years)
B: The acceptability of the intervention to patients (within 6 months of study completion); The feasibility of intervention delivery at the ER setting (within 6 months of study completion); Patient recruitment (Baseline); The proportion of participating patients who can be reached by telephone contact at the 3-month follow-up. (3 months); The proportion of participating patients who can be reached by telephone contact at the 6-month follow-up. (6 months); The proportion of participating patients who can be traced from the hospital record at the 3-month. (3 months); The proportion of participating patients who can be traced from the hospital record at the 6-month. (6 months); The proportion of participating patients whose identity card number can be linked to the nationwide self-harm registry at the 6-month. (6 months); The proportion of participating patients whose identity card number can be linked to the nationwide self-harm registry at the 3-month. (3 months); Change in scores on a self-report suicidal behaviors assessment from baseline to 3 months (Baseline, 3 months); Change in scores on a self-report suicidal behaviors assessment from baseline to 6 months (Baseline, 6 months); Number of repeat self-harm episodes per person in 3 months after intervention based on hospital records (3 months); Number of repeat self-harm episodes per person in 3 months after intervention recorded in the nationwide self-harm registry (3 months); Number of repeat self-harm episodes per person in 6 months after intervention based on hospital records (6 months); Number of repeat self-harm episodes per person in 6 months after intervention recorded in the nationwide self-harm registry (6 months); Time to next self-harm repetition (in days) following randomization (6 months)
C: Suicide Attempts (Assessed bimonthly)
D: change from baseline in borderline symptoms after a 10 week intervention (10 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Active-controlled, Clinical Trial Comparing Effects of Mindfulness and Interpersonal Effectiveness Skills in Borderline Personality Disorder
Brief Summary: The purpose of the study was to determine whether mindfulness training could be more effective than another active intervention in reducing borderline personality disorder (BPD) symptoms. The main hypothesis was that patients allocated to the mindfulness group would show a greater improvement on global BPD symptomatology. As a second objective, we explored some of the possible underlying mechanisms of both active treatments. For that purpose, changes in decentering, mindfulness facets and cognitive processing of social interactions were also evaluated.


Options:
A: Drop-out (1 year); Suicidality (Suicide Attempts) (1 year)
B: change from baseline in borderline symptoms after a 10 week intervention (10 weeks)
C: NICU health professional resilience (10 days, 1 month, 6 months, 12 months)
D: Clinical Global Impression (CGI): Improvement (1-7): score 3 ( a little better) associated with a hopelessness scale score < 8 (this means that the suicide risk is low)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Active-controlled, Clinical Trial Comparing Effects of Mindfulness and Interpersonal Effectiveness Skills in Borderline Personality Disorder
Brief Summary: The purpose of the study was to determine whether mindfulness training could be more effective than another active intervention in reducing borderline personality disorder (BPD) symptoms. The main hypothesis was that patients allocated to the mindfulness group would show a greater improvement on global BPD symptomatology. As a second objective, we explored some of the possible underlying mechanisms of both active treatments. For that purpose, changes in decentering, mindfulness facets and cognitive processing of social interactions were also evaluated.


Options:
A: change from baseline in borderline symptoms after a 10 week intervention (10 weeks)
B: Change in mindfulness (Baseline and after 12-weeks); Change in borderline symptom severity (Baseline and after 12-weeks); Change in overall psychiatric symptom severity (Baseline and after 12-weeks); Change in severity in symptoms of depression (Baseline and after 12-weeks)
C: Repetition of self-harm (Three months); Change scores on the Suicide Behaviors Questionnaire from baseline (Baseline and three months)
D: Parasuicidal behaviour (intermittent)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impact of Different Treatment Strategies on the Transmission Dynamics of Soil-transmitted Helminths: a Cluster Randomised Trial in Kenya
Brief Summary: The mainstay of control of soil-transmitted helminths (STH) is school-based deworming but recent modelling has highlights that in all but low very transmission settings, the treatment of school-aged children is unlikely to interrupt transmission, and that new treatment strategies are required. This study seeks to answer the question: is it possible to interrupt the transmission of STH and if so, what is the most cost-effective treatment strategy and delivery system to achieve this goal? In this study, two paired community cluster randomised trials in different settings in Kenya will evaluate the impact and cost-effectiveness of annual school-based deworming, annual community-based deworming, and biannual community-based deworming. The interventions are (i) annual mass anthelmintic treatment delivered either to pre-school and school-aged children, as part of a national school-based deworming programme, or to the entire community delivered by community health workers. The primary outcome measure is the prevalence of hookworm infection (the most common STH species), assessed by periodic cross-sectional, age-stratified parasitological surveys. Secondary outcomes include intensity of hookworm, prevalence and intensity of Ascaris lumbricoides, treatment coverage, and among a randomly selected sub-sample of participants who will be followed longitudinally, worm burden and proportion of eggs unfertilised. A nested process evaluation, using semi-structured interviews, focus group discussions and a stakeholder analysis will investigate the community acceptability, feasibility given the local and regional health system structures and processes, and scale-up of the interventions.


Options:
A: parasite cleared and reduced up to 80% at day 42 (42 days)
B: Validation of the performance of FECPAKG2 to assess drug efficacy (up to 12 months); In depth evaluation of the FECPAKG2 technique to assess drug efficacy (up to 12 months); Validation of b-tubulin gene as a molecular marker for benzimidazole resistance (up to 24 months)
C: intestinal parasitic infections (6 months)
D: Prevalence of hookworm in community members (Endline survey conducted, approximately 24 months after starting the intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of Repeated-Dose Intravenous Ketamine for PTSD
Brief Summary: The purpose of this study is to study new ways to treat post-traumatic stress disorder (PTSD). Current treatments for PTSD do not work for everyone and it can take time to determine whether a person responds to a chosen treatment. The purpose of this study is to see whether ketamine, when given repeatedly intravenously can produce a quick and persistent improvement in PTSD symptoms. At higher doses, ketamine has been used for many years as an anesthetic for medical procedures, and at lower doses may be an effective treatment in patients with major depression and PTSD. Ketamine given for PTSD is investigational, which means that the FDA has not yet approved the drug for treating this condition. In this study, the effects of ketamine will be compared to those of midazolam. Midazolam has similar acute anesthetic effects compared to ketamine but has not been shown to treat or alleviate any symptoms of PTSD. This makes midazolam an appropriate substance to gauge whether ketamine can treat or alleviate PTSD symptoms thereby acting as what we call an active control.


Options:
A: Efficacy, Measured by Change in the Clinician-Administered PTSD Scale (CAPS) Score (Baseline, Week 6)
B: CAPS Recurrent Distressing Dreams Item (This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.); Pittsburgh Sleep Quality Index (PSQI) (This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.); Clinical Global Impression of Change (CGIC) (This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.)
C: Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) (2 weeks after the first infusion)
D: Symptoms of post-traumatic stress disorder (Measured at Month 3); Symptoms of depression (Measured at Month 3)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Supporting Dyads Affected by Heart Failure - A Randomised Controlled Study Evaluating a Psychoeducational Intervention
Brief Summary: The aim of this randomized controlled trial was to evaluate the effects of an integrated dyad care program with education and psychosocial support to patients with chronic heart failure and their partners during a post-discharge period after acute deterioration of heart failure.

Methods: One hundred fifty five patient-caregiver dyads has been randomized to usual care or a psycho-education intervention delivered in three modules through nurse-led face-to-face counseling, computer-based education and other written teaching materials to assist dyads develop problem-solving skills. Follow-up assessments has been completed after 3, 12 and 24 months to assess perceived control, perceived health, depressive symptoms, self-care, knowledge, caregiver burden and health care utilization.


Options:
A: Perceived control measure by Control Attitude Scale (3 months)
B: Anxiety (Baseline); Anxiety (14 weeks); Anxiet (26 weeks); Anxiety (52 weeks)
C: Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c (Baseline to 12 months); Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); Systolic Blood Pressure at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); LDL Cholesterol at Baseline and 12 Months (Measured at Baseline and 12 months); Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 months and 12 months)
D: Death (4 months); Death (8 months); Death (12 months); Death (16 months); Death (20 months); Death (24 months); Death (3 years); Death (4 years); Stroke/Systemic embolism (SE) (4 months); Stroke/Systemic embolism (SE) (8 months); Stroke/Systemic embolism (SE) (12 months); Stroke/Systemic embolism (SE) (16 months); Stroke/Systemic embolism (SE) (20 months); Stroke/Systemic embolism (SE) (24 months); Stroke/Systemic embolism (SE) (3 years); Stroke/Systemic embolism (SE) (4 years); Major bleeding (4 months); Major bleeding (8 months); Major bleeding (12 months); Major bleeding (16 months); Major bleeding (20 months); Major bleeding (24 months); Major bleeding (3 years); Major bleeding (4 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Supporting Dyads Affected by Heart Failure - A Randomised Controlled Study Evaluating a Psychoeducational Intervention
Brief Summary: The aim of this randomized controlled trial was to evaluate the effects of an integrated dyad care program with education and psychosocial support to patients with chronic heart failure and their partners during a post-discharge period after acute deterioration of heart failure.

Methods: One hundred fifty five patient-caregiver dyads has been randomized to usual care or a psycho-education intervention delivered in three modules through nurse-led face-to-face counseling, computer-based education and other written teaching materials to assist dyads develop problem-solving skills. Follow-up assessments has been completed after 3, 12 and 24 months to assess perceived control, perceived health, depressive symptoms, self-care, knowledge, caregiver burden and health care utilization.


Options:
A: Motivation (12 weeks); Needs Satisfaction (12 weeks)
B: Cardiac Rehabilitation Enrollment (12 weeks after patient is discharged from hospital)
C: Perceived control measure by Control Attitude Scale (3 months)
D: The primary outcome was a composite end-point of a first visit to the emergency department (lasting less than 24 hours), or a first hospital readmission (> 24h) or all-cause death, assessed during the first 6 months of follow-up. (Up to 36 months.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Supporting Dyads Affected by Heart Failure - A Randomised Controlled Study Evaluating a Psychoeducational Intervention
Brief Summary: The aim of this randomized controlled trial was to evaluate the effects of an integrated dyad care program with education and psychosocial support to patients with chronic heart failure and their partners during a post-discharge period after acute deterioration of heart failure.

Methods: One hundred fifty five patient-caregiver dyads has been randomized to usual care or a psycho-education intervention delivered in three modules through nurse-led face-to-face counseling, computer-based education and other written teaching materials to assist dyads develop problem-solving skills. Follow-up assessments has been completed after 3, 12 and 24 months to assess perceived control, perceived health, depressive symptoms, self-care, knowledge, caregiver burden and health care utilization.


Options:
A: Low-density lipoprotein (LDL)cholesterol (Baseline and 12 months); Blood pressure (baseline and 12 months); Body Mass Index (baseline and 12 months); Psychological Well-Being (Baseline and 12 months)
B: Re-hospitalization and death rates (Measured at Month 12); Total hospitalizations (Measured at Month 12); HF-specific quality of life (Measured at Months 6 and 12)
C: Perceived control measure by Control Attitude Scale (3 months)
D: composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke (every six months for an average of 5.4 years)

Answer: C