TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Health Coaching to Reduce Disparities for Patients With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: This study examined whether health coaches can improve the management of chronic obstructive pulmonary disease (COPD) in a population of vulnerable patients cared for in 'safety-net' clinics. The study is designed as a randomized controlled trial for patients with moderate to severe COPD. Patients were randomized into a health coaching group and a usual care group. Those in the health coaching group received 9 months of active health coaching. Outcome variables were measured at baseline and after 9 months


Options:
A: Changes in EQ ED From Baseline to 3 Months Endpoint (Baseline and change at 3 months); Changes in the Symptom Burden of Disease From Baseline to 3 Months (Baseline with change at 3 months); Changes in Quality of Life (Mood) From Baseline to 3 Month Endpoint (Baseline and change at 3 months); Changes in Quality of Life (Anxiety) From Baseline to 3 Month Endpoint (Baseline and change at 3 months)
B: Change in physical activity (Baseline and 12 months follow-up)
C: Clinical health, including lung function and respiratory symptoms (Measured at baseline and every 3 months for 18 months)
D: Short Form Chronic Respiratory Disease Questionnaire (CRQ-SF) Total Score (9 months); Dyspnea Domain Score of the Short Form of the Chronic Respiratory Disease Questionnaire (CRQ-SF) (9 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment Adherence in Pediatric Multiple Sclerosis
Brief Summary: Disease modifying therapies (DMT) are widely used for children and adolescents with MS. Nonetheless, many pediatric patients continue to relapse and therefore require changes in therapy. We designed this research study to learn more about medication use in children and adolescents with MS. We are also interested in learning what a behavioral feedback intervention can tell us about adherence to medicine. Finally, we hope this research project will inform the way we provide clinical care for children and adolescents with MS.


Options:
A: Change in Level of Adherence in Subjects (Objective Measure) (Baseline, 3 months, 6 months); Change in Level of Adherence in Subjects (Parent- and Patient-Reported): MSTAQ (Baseline, 3 months, 6 months); Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Morisky (Baseline, 3 months, 6 months); Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Parental Involvement (Baseline, 3 months, 6 months)
B: Change in Functional Disability (Baseline, 8 weeks, 16 weeks, 10 months, 12 months)
C: PATIENT-RATED LOW BACK PAIN (3 and 12 months)
D: Feasibility and retention (8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Early Childhood Development in Zambia
Brief Summary: The purpose of this study is to evaluate the impact of a community-based early childhood development (ECD) program on children's physical and cognitive development. Under the program, targeted communities will be assigned a trained Child Development Agent (CDA) who will have four main tasks and responsibilities: 1) biweekly screening and management (including referral) of acute malnutrition in children; 2) encouragement of caregivers to utilize routine care services for children; 3) screening for symptoms of acute diseases including malaria, diarrhea, and pneumonia and referral for diagnosis and treatment; and 4) organization and mentoring of biweekly caregiver meetings to discuss parenting and promote early childhood cognitive stimulation. The investigators will enroll at baseline around 600 children ages 6 - 12 months and their caregivers, and randomize them at the community-level to receive the ECD program or to remain in the control group. The study period will be one year. At end line, the investigators will collect important indicators of child physical and cognitive development to assess program impact. If the program shows both feasibility and impact, there is the potential to integrate program interventions into existing national community-based health initiatives.

Amendment: the study period has been extended for a second year. After a five month gap when no intervention was provided, biweekly (i.e., fortnightly) community-based parenting groups were restarted in intervention clusters. In the second year of the intervention, CDAs no longer visit households.


Options:
A: Feasibility as assessed through the John Hopkins Implementation and Dissemination Science Scale (Immediately after the intervention); Acceptability as assessed through the John Hopkins Implementation and Dissemination Science Scale (Immediately after the intervention)
B: General psychological distress - General Health Questionnaire (20-weeks after baseline)
C: Stunting (One year starting with baseline (August-September 2014) and finishing with end line (September 2015); Amendment: also measured at year two (extension) endline); Cognitive function (End line (after one year); Amendment: BSID-III at year two (extension) endline)
D: Child development composite score (Change children's cognition, language and motor as composite score after one year intervention); Children's behavior and composite score (Change children's behaviour after one year intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Early Childhood Development in Zambia
Brief Summary: The purpose of this study is to evaluate the impact of a community-based early childhood development (ECD) program on children's physical and cognitive development. Under the program, targeted communities will be assigned a trained Child Development Agent (CDA) who will have four main tasks and responsibilities: 1) biweekly screening and management (including referral) of acute malnutrition in children; 2) encouragement of caregivers to utilize routine care services for children; 3) screening for symptoms of acute diseases including malaria, diarrhea, and pneumonia and referral for diagnosis and treatment; and 4) organization and mentoring of biweekly caregiver meetings to discuss parenting and promote early childhood cognitive stimulation. The investigators will enroll at baseline around 600 children ages 6 - 12 months and their caregivers, and randomize them at the community-level to receive the ECD program or to remain in the control group. The study period will be one year. At end line, the investigators will collect important indicators of child physical and cognitive development to assess program impact. If the program shows both feasibility and impact, there is the potential to integrate program interventions into existing national community-based health initiatives.

Amendment: the study period has been extended for a second year. After a five month gap when no intervention was provided, biweekly (i.e., fortnightly) community-based parenting groups were restarted in intervention clusters. In the second year of the intervention, CDAs no longer visit households.


Options:
A: Change in scores on the Oxford Measure of Psychosocial Adjustment & World Health Organization Disability Assessment Schedule, 2.0 (WHODAS 2.0) (Administered at 4 timepoints: (1) baseline; (2) within 15 days of YRI completion; (3) 6 months post-YRI; (4) 12 months post-YRI)
B: Change from baseline post traumatic stress symptoms at 6 months (baseline and 6 month follow up); Change from baseline depression symptoms at 6 months (baseline and 6 month follow up); Change from baseline hope at 6 months (baseline and 6 month follow up)
C: Stunting (One year starting with baseline (August-September 2014) and finishing with end line (September 2015); Amendment: also measured at year two (extension) endline); Cognitive function (End line (after one year); Amendment: BSID-III at year two (extension) endline)
D: Score Difference in Symptoms of Anxiety, Depression and Post-traumatic Stress Disorders. (Within the fifteen (15) days after finishing the intervention, either Common Elements Treatment Approach (CETA) or Narrative Community Group Therapy (NCGT). In the control group, 12 weeks after the baseline assessment.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Open-label, Active-controlled, Randomized Study to Evaluate the Efficacy and Safety of an age-and Body Weight-adjusted Rivaroxaban Regimen Compared to Standard of Care in Children With Acute Venous Thromboembolism
Brief Summary: The purpose of this study is to evaluate comparative efficacy and safety of rivaroxaban to standard of care in children with acute venous thromboembolism.


Options:
A: Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period (6 months)
B: Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment (3-, 6-, or 12-month study treatment period)
C: Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period (During the main study treatment period (i.e., 3 months, except for children with central venous catheter venous thromboembolism (CVC-VTE) aged <2 years for whom it was 1 month)); Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period (During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged <2 years for whom it was 1 month)); Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During Extended Treatment Period (During extended treatment period: up to month 12.); Number of Subjects With the Composite of All Symptomatic Recurrent Venous Thromboembolism During the 30 Days Post-study Treatment Period (i.e. >2 and ≤ 30 Days After Stop of Study Medication) (More than 2 and up to 30 days after stop of study medication); Incidence Rates of the Composite of Treatment Emergent Overt Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding During Main Treatment Period (During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged <2 years for whom it was 1 month)); Incidence Rates of the Composite of Treatment Emergent Overt Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding During Extended Treatment Period (During extended treatment period: up to month 12.)
D: Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations at Steady State (C Trough,ss) at Week 1 (Week 1); Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 2 (Week 2); Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 4 (Week 4); Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at End of Trial (EoT) at Week 12 (Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Open-label, Active-controlled, Randomized Study to Evaluate the Efficacy and Safety of an age-and Body Weight-adjusted Rivaroxaban Regimen Compared to Standard of Care in Children With Acute Venous Thromboembolism
Brief Summary: The purpose of this study is to evaluate comparative efficacy and safety of rivaroxaban to standard of care in children with acute venous thromboembolism.


Options:
A: Composite Primary Endpoint (From the time of randomisation until Week 12, 84 days after randomisation including a visit window of 7 days.)
B: Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE (For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180))
C: Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period (During the main study treatment period (i.e., 3 months, except for children with central venous catheter venous thromboembolism (CVC-VTE) aged <2 years for whom it was 1 month)); Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period (During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged <2 years for whom it was 1 month)); Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During Extended Treatment Period (During extended treatment period: up to month 12.); Number of Subjects With the Composite of All Symptomatic Recurrent Venous Thromboembolism During the 30 Days Post-study Treatment Period (i.e. >2 and ≤ 30 Days After Stop of Study Medication) (More than 2 and up to 30 days after stop of study medication); Incidence Rates of the Composite of Treatment Emergent Overt Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding During Main Treatment Period (During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged <2 years for whom it was 1 month)); Incidence Rates of the Composite of Treatment Emergent Overt Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding During Extended Treatment Period (During extended treatment period: up to month 12.)
D: Incidence of Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or VTE-Related Death During 6 Months of Treatment (Day 1 to Week 24 + 2 Days or 355 days (Discontinued Early))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Aldosterone Targeted Neurohormonal Combined With Natriuresis Therapy - HF (ATHENA-HF)
Brief Summary: The primary objective of this study is to test the hypothesis that high-dose spironolactone will lead to greater proportional reduction in NT-proBNP levels from randomization to 96 hours over standard of care.


Options:
A: Percentage of Participants With a Relative Decrease in NT-proBNP of More Than 30% From Baseline to Day 90 (Baseline and Day 90)
B: 96 Hour Change in NT-proBNP (Randomization to 96 hours)
C: Urinary albumin excretion (18 months)
D: Change of of Systolic Blood Pressure (4 months); Change of Diastolic Blood Pressure (4 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: iChoose Kidney Decision Aid for Treatment Options Among End-Stage Renal Disease (ESRD) Patients
Brief Summary: The investigators developed iChoose Kidney -- a shared decision-making support tool accessible through iPad, iPhone, or the web -- to provide ESRD patients and their providers with a simple, standardized, easily accessible, statistically robust tool for use in the clinic to guide patient education and healthcare decision-making about treatment options of dialysis or kidney transplantation. The iChoose Kidney decision aid provides patients with estimates of their individualized 1 and 3-year risks of mortality on dialysis vs. transplantation, based on previous national data. The tool has the potential to improve communication and decision-making between patients and their healthcare providers and improve access to kidney transplantation among patients with ESRD.

This will be a two-arm, randomized study, and will be conducted at 3 large transplant centers with diverse patient populations. One group of patients will receive standard education alone during their scheduled transplant evaluation. The second group will receive the standard education as well have the provider use the iChoose Kidney aid with them. The project timeline will be a total of 24 months inclusive of enrollment, follow-up, data analysis, and outcome evaluation.

This study will assess how well the iChoose decision aid works in improving patient knowledge, preferences for treatment, and patient access to transplant. The study will also assess whether providers find the tool useful for providing ways to share information with patients about ways to treat their kidney disease.


Options:
A: Effectiveness of the iChoose Kidney intervention to improve knowledge and shared decision-making between patients and physicians regarding ESRD treatment options. (Up to 19 months)
B: Deceased Donor Kidney Transplant (DDKT) and Living Donor Kidney Transplant (DDKT) Knowledge (9 months)
C: Consent to psychological screen rate using self-report measures of depression (PHQ-9) and anxiety (GAD-7) (Baseline recruitment/screening)
D: medication adherence (5 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: iChoose Kidney Decision Aid for Treatment Options Among End-Stage Renal Disease (ESRD) Patients
Brief Summary: The investigators developed iChoose Kidney -- a shared decision-making support tool accessible through iPad, iPhone, or the web -- to provide ESRD patients and their providers with a simple, standardized, easily accessible, statistically robust tool for use in the clinic to guide patient education and healthcare decision-making about treatment options of dialysis or kidney transplantation. The iChoose Kidney decision aid provides patients with estimates of their individualized 1 and 3-year risks of mortality on dialysis vs. transplantation, based on previous national data. The tool has the potential to improve communication and decision-making between patients and their healthcare providers and improve access to kidney transplantation among patients with ESRD.

This will be a two-arm, randomized study, and will be conducted at 3 large transplant centers with diverse patient populations. One group of patients will receive standard education alone during their scheduled transplant evaluation. The second group will receive the standard education as well have the provider use the iChoose Kidney aid with them. The project timeline will be a total of 24 months inclusive of enrollment, follow-up, data analysis, and outcome evaluation.

This study will assess how well the iChoose decision aid works in improving patient knowledge, preferences for treatment, and patient access to transplant. The study will also assess whether providers find the tool useful for providing ways to share information with patients about ways to treat their kidney disease.


Options:
A: Pursuit of Living Related Transplantation (6 months)
B: Knowledge about the disease (3 months); Satisfaction about the treatment (3 months); Self-esteem (3 months)
C: Number of Adverse Events Reported During the Study. (Thru the Month 24 Visit); Change in C-peptide (Baseline to the Month 6 Visit)
D: Effectiveness of the iChoose Kidney intervention to improve knowledge and shared decision-making between patients and physicians regarding ESRD treatment options. (Up to 19 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Folic Acid Supplementation Lowering Arsenic in a Chronic, Low-level Exposed Arsenic Population: a Randomized, Double-blind, Placebo Controlled Clinical Trial.
Brief Summary: The purpose of this study is to determine whether folic acid supplementation are effective on arsenic lowering in a chronic, low-level arsenic exposed population.


Options:
A: Infant Mortality Through 6 mo of Age (6-months post-birth)
B: Change of urine arsenic metabolites between baseline and week 8 (baseline, week 8)
C: Change in arsenic methylation (Up to 12 Weeks); Change in in blood arsenic (Up to 12 Weeks); Change in blood monomethyl arsenic (Up to 12 Weeks)
D: blood arsenic concentrations (24 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Brief Skills Training Intervention for Suicidal Individuals
Brief Summary: A significant percentage of individuals who die by suicide do not seek mental health services in the time preceding their death. This population is underserved and it is unclear what barriers keep them from seeking treatment. In order to begin a line of research aimed at addressing this high-risk population, this proposal rests on the hypothesis that suicidal individuals who do not seek treatment prior to attempting suicide experience the same psychopathological difficulties as suicidal individuals who do seek treatment - namely, severe emotion dysregulation. However, these non-treatment-seeker s will likely require more creative recruitment strategies and briefer interventions than treatment-seeking individuals. As such, this application proposes to use wide-reaching recruitment efforts throughout the community to locate and enroll individuals who are suicidal but not seeking treatment. Further, there is a paucity of empirical support for interventions targeting suicidal individuals. Dialectical Behavior Therapy (DBT) is one of the few treatments that have been demonstrated to be effective with a suicidal population and is the only treatment whose effectiveness has been replicated. Previous research has suggested that an abbreviated version of the skills that are taught in DBT skills training have effectively reduced emotion dysregulation (i.e., depression and anxiety) in problem drinkers and the format of the proposed intervention is derived from this evidence-based emotion dysregulation intervention. As such, the proposed research is a randomized, controlled pilot trial of a very brief, one-time, skills-based intervention targeting difficulties in emotion regulation and distress tolerance.

This research aims to evaluate the safety of the intervention, the feasibility of the research methods (including the appropriateness of the relaxation training control condition), and to preliminarily estimate the immediate (one week) and long-term (one and three month) changes resulting from the DBT Brief Skills Intervention (DBT-BSI) relative to a relaxation training control on the primary outcomes of suicide ideation and emotion dysregulation as well as a number of secondary outcomes. These results will inform the design of a subsequent full-scale randomized controlled trial of the DBT-BSI.


Options:
A: Scale for Suicidal Ideation (12-weeks of follow-up); Difficulties in Emotion Regulation Scale (12-weeks of follow-up); DBT Ways of Coping Scale (12-weeks of follow-up)
B: Repeat suicide attempts (Measured during treatment and 1, 3, 6, 12, 18, and 24 months after study completion)
C: Change in suicidal ideation severity as measured by the Suicidal Ideation Questionnaire - Jr (Screening, 6 weeks, 24 weeks)
D: 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)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Complementary Therapies Delivered Via Mobile Technologies on Surgical Patients' Reports of Anxiety, Pain, and Self-Efficacy in Healing: A Pilot Randomized Controlled Trial in Iceland
Brief Summary: The purpose of this study is to determine the effects of complementary therapies delivered via mobile technologies have a therapeutic effect on surgical patients' anxiety, pain, and self-efficacy in healing reports before, following, and at 10-day follow-up.


Options:
A: Change from baseline state anxiety via the State Trait Anxiety Scale (STAI) (Ten days)
B: SCL-90r Depression and anxiety subscales (baseline - 12 months)
C: Physiotherapeutic Rehabilitation after THA. (15 days after discharge)
D: change from baseline in perceived health status at six months (baseline and six months)

Answer: A