TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Group Interventions for Suicidal African Americans
Brief Summary: The investigator is conducting a hybrid efficacy-effectiveness randomized controlled trial with low-income African American suicide attempters. Guided by the Theory of Triadic Influence (TTI), this pilot randomized controlled trial aims:

1. to determine if psychosocial group intervention (PGI) is more effective than enhanced treatment as usual (ETAU) in reducing suicidal behavior (ideation, attempts; primary outcome) and improving its correlates (depressive symptoms, hopelessness, quality of life) (secondary outcomes) in low-income African Americans with a recent attempt.
2. to determine if PGI is more effective than ETAU at bolstering intrapersonal (I), social/situational (SS), and cultural/environmental (CE) risk and protective factors that mediate the condition-suicidal behavior and correlates link and thus serve as mechanisms of change.
3. to determine I, SS, and CE variables that moderate the condition-suicidal behavior link and thus serve as predictors of intervention outcome.

Hypothesis for Aim 1: At post-intervention and follow-up, PGI participants will evidence greater improvements in suicidal behavior and its correlates than those in ETAU.

Hypothesis for Aim 2: Changes in these risk and protective factors will account for condition effects on outcomes: (1) psychological distress, aggression, impulsivity, substance abuse, low self-esteem, and suicide acceptability (I-risk); (2) perceived burdensomeness and thwarted belongingness, relationship discord, intimate partner violence perpetration and victimization (SS-risk); (3) access to a weapon and barriers to service utilization (CE-risk); (4) reasons for living, optimism, positive ethnic identity, effective coping, and spiritual well-being (I-protective); (5) overall family health and social support from family and friends (SS-protective); and (6) religious involvement and effectiveness of obtaining resources (CE-protective).

Hypothesis for Aim 3: Individuals (1) having fewer Diagnostic and Statistical Manual of Mental Disorders (DSM) disorders and attachment styles characterized by positivity toward the self and others (I); (2) children and more limited trauma histories (SS); and (3) more daily hassles and less exposure to community disorder (CE) will evidence greater reductions in suicidal behavior and its correlates and greater enhancements in quality of life at post-intervention and follow-up.


Options:
A: Suicide repetition (or death by suicide) (12 months)
B: Change in scores on Beck Scale for Suicidal Ideation (Baseline, post-therapy, 6 months and 12 months after therapy)
C: Impact of omega-3 HUFA supplementation on suicidal behaviors and thinking among adults. (6 months)
D: Change in Number of Deaths by Suicide and/or Re-Presentations to Any Emergency Department (ED) in Ontario for Self-Harm - Data from the Institute for Clinical Evaluative Sciences (ICES) (Baseline; 12 Months.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Group Interventions for Suicidal African Americans
Brief Summary: The investigator is conducting a hybrid efficacy-effectiveness randomized controlled trial with low-income African American suicide attempters. Guided by the Theory of Triadic Influence (TTI), this pilot randomized controlled trial aims:

1. to determine if psychosocial group intervention (PGI) is more effective than enhanced treatment as usual (ETAU) in reducing suicidal behavior (ideation, attempts; primary outcome) and improving its correlates (depressive symptoms, hopelessness, quality of life) (secondary outcomes) in low-income African Americans with a recent attempt.
2. to determine if PGI is more effective than ETAU at bolstering intrapersonal (I), social/situational (SS), and cultural/environmental (CE) risk and protective factors that mediate the condition-suicidal behavior and correlates link and thus serve as mechanisms of change.
3. to determine I, SS, and CE variables that moderate the condition-suicidal behavior link and thus serve as predictors of intervention outcome.

Hypothesis for Aim 1: At post-intervention and follow-up, PGI participants will evidence greater improvements in suicidal behavior and its correlates than those in ETAU.

Hypothesis for Aim 2: Changes in these risk and protective factors will account for condition effects on outcomes: (1) psychological distress, aggression, impulsivity, substance abuse, low self-esteem, and suicide acceptability (I-risk); (2) perceived burdensomeness and thwarted belongingness, relationship discord, intimate partner violence perpetration and victimization (SS-risk); (3) access to a weapon and barriers to service utilization (CE-risk); (4) reasons for living, optimism, positive ethnic identity, effective coping, and spiritual well-being (I-protective); (5) overall family health and social support from family and friends (SS-protective); and (6) religious involvement and effectiveness of obtaining resources (CE-protective).

Hypothesis for Aim 3: Individuals (1) having fewer Diagnostic and Statistical Manual of Mental Disorders (DSM) disorders and attachment styles characterized by positivity toward the self and others (I); (2) children and more limited trauma histories (SS); and (3) more daily hassles and less exposure to community disorder (CE) will evidence greater reductions in suicidal behavior and its correlates and greater enhancements in quality of life at post-intervention and follow-up.


Options:
A: Change in scores on Beck Scale for Suicidal Ideation (Baseline, post-therapy, 6 months and 12 months after therapy)
B: Clinical changes after 16 sessions of Dialectical Behavioral Therapy. (4 months); Neural changes after 16 sessions of Dialectical Behavioral Therapy. (4 months); Neuropsychological changes after 16 sessions of Dialectical Behavioral Therapy. (4 months)
C: Suicide Mortality Rates (Study Completion (2 years))
D: First recurrent suicide behavior (suicide attempted and completed suicide) (Minimum 1.5 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Primary Hyperparathyroidism: Short-term Calcimimetics Treatment - Relevance for Parathyroid Surgery Decisions?
Brief Summary: Patients with primary hyperparathyroidism (pHPT) often present with fatigue, psychological and cognitive symptoms. Improvement in these symptoms after parathyroid adenomectomy (PTX) has been reported. But physicians lack a method to attribute the symptoms to pHPT and to predict the reversibility after PTX.

This study aims to evaluate short-term calcimimetic treatment as a tool for predicting the outcome of PTX on muscle strength, quality of life, psychological symptoms, and cognitive function in patients with pHPT.

Material and Methods: 118 patients scheduled for PTX at Karolinska University Hospital, Sweden, will have a four week treatment with calcimimetics (Mimpara®) before undergoing surgery. Biochemicals, muscle strength, quality of life, psychological symptoms and cognitive function will be analysed at baseline, after four week follow-up and postoperatively.

Hypothesis: The outcome of short-term calcimimetic treatment can predict the outcome of PTX on muscle strength, quality of life, psychological symptoms, and cognitive function in patients with pHPT


Options:
A: Decrease in arterial stiffness after parathyroidectomy (3 month)
B: postoperative parathyroid hormone level (3 months); ambulatory blood pressure (one year)
C: Predictive outcome in Quality of Life after parathyroidectomy (after four weeks of calcimimetic treatment and postoperatively)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Addition of Evacetrapib to Atorvastatin Compared to Placebo, High Intensity Atorvastatin, and Atorvastatin With Ezetimibe to Evaluate LDL-C Lowering in Patients With Primary Hyperlipidemia - The ACCENTUATE Study
Brief Summary: The purpose of the ACCENTUATE study is to evaluate whether the study drug known as evacetrapib is effective in treating participants with high cholesterol and atherosclerotic cardiovascular disease (ASCVD) and/or diabetes.


Options:
A: Switching to a combination tablet of ezetimibe 10 mg plus simvastatin 20 mg is superior to doubling the statin dose as demonstrated by the percentage of patients reaching goal after 12 weeks of treatment. (after 12 weeks of treatment)
B: the percent change in coronary plaque volume the percent change in integrated backscatter signal obtained by integrated backscatter IVUS (9-11 month)
C: Change in ultrasound-determined average carotid artery intima-media thickness (IMT) on a per subject basis between baseline and endpoint. (24 months)
D: Percent Change From Baseline to 3 Months in Low-Density Lipoprotein Cholesterol (LDL-C) (Baseline, 3 Months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Alcohol, Suicide, and HIV Prevention for Teens in Mental Health Treatment
Brief Summary: This study examines whether an integrated alcohol/substance abuse, suicide, and HIV prevention protocol is associated with lower onset and frequency of alcohol and other drug use, suicidal behavior, and high risk sexual behavior among adolescents receiving community based mental health care.


Options:
A: adolescent alcohol use and binge drinking (any, number of days, number of related problems) (change from baseline to 6 months (prior 3 months)); adolescent suicidal ideation and behavior (severity of suicidal ideation and presence of any suicidal ideation or suicidal behavior) (change from baseline to 6 months (prior month to 6 months)); adolescent HIV risk behavior (any sexual behavior, number of sexual partners, number of unprotected sexual acts) (change from baseline to 6 months (prior 3 months)); adolescent marijuana use (any use, number of days, related problems) (change from baseline to 6 months (prior 3 months)); adolescent alcohol use and binge drinking (any, number of days, number of related problems) (change from baseline to 12 months (prior 3 months)); adolescent suicidal ideation and behavior (severity of suicidal ideation and presence of any suicidal ideation or suicidal behavior) (change from baseline to 12 months (prior month to 6 months)); adolescent HIV risk behavior (any sexual behavior, number of sexual partners, number of unprotected sexual acts) (change from baseline to 12 months (prior 3 months)); adolescent marijuana use (any use, number of days, related problems) (change from baseline to 12 months (prior 3 months))
B: Non-suicidal self-harm (6 months); Suicidal ideation (6 months); suicide attempts (6 months)
C: Suicide Attempt (3-months); Suicide-related hospitalizations (Measured at month 3)
D: suicide/attempted suicide (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Nurse-led Care Program on Quality of Life and Health Care Utilization for Cancer Patients in a Chemotherapy Day Center: A Randomized Controlled Trial
Brief Summary: A nurse-led care program for cancer patients receiving chemotherapy in an outpatient setting was formulated. The aim of the study was to assess the effect of this nurse-led care program on cancer patients who received neo-adjuvant/adjuvant chemotherapy in a chemotherapy day center in terms of quality of life, symptom experiences, self-efficacy, health care utilization, and satisfaction with care. Specifically, the objectives are:

* To compare the differences of health care utilization between the two arms.
* To compare the differences of cancer patients' satisfaction with care between the two arms.
* To explore the experiences of cancer patients in the intervention arm.
* To understand the experiences of the intervention nurses of the program and their opinions on further development.


Options:
A: The efficacy of Mindfulness Based Stress Reduction on mood disorders (up to 5 years follow up)
B: Change in quality of life (T0: before chemotherapy (week 0); T1: in the middle of chemotherapy (i.e. week 4 to 10); T2: three weeks after last cycle of chemotherapy (i.e. week 13 to 20).)
C: Recurrence event (Ten years); Recurrence time (Ten years)
D: Physical Well-being a Subcale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) (Baseline and 6 month assessment); Social/Family Well-being a Subcale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) (Baseline and 6 month assessment); Emotional Well-being a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) (Baseline and 6 month assessment); Breast Cancer Concerns a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) (Baseline and 6 month assessment); Enjoyment of Life a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) (Baseline and 6 month assessment); Total Score of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) (Baseline and 6 month assessment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Study on the Tailored Intervention Strategy of Childhood Obesity Based on Monitoring Physical Activities and Dietary Behaviors
Brief Summary: The project aims at developing the tailored intervention strategy of childhood obesity based on monitoring physical activities with accelerometer and dietary behaviors using diary. It probably raise the passion of obese children to control weight, form healthy life style, be effective in sustaining weight loss and early prevent adulthood diseases.


Options:
A: Change in body mass index (BMI) (Baseline, Month 3)
B: Change in body mass index (Baseline, 1-year post-intervention)
C: MET-weighted MVPA: Daily Minutes of Moderate-to-vigorous Physical Activity (MVPA) Weighted by Metabolic Equivalent of Task (MET) (Post-2 year intervention); MET-weighted MVPA: Daily Minutes of Moderate-to-vigorous Physical Activity (MVPA) Weighted by Metabolic Equivalent of Task (MET) (Post-3 year intervention)
D: Smoking prevalence of adolescents in each group (six years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of the Walking Intervention Walkadoo: A Randomized Controlled Pilot Trial in an Employee Population
Brief Summary: This study evaluates the product Walkadoo to determine whether it effectively increases walking behavior in healthy adults.


Options:
A: Change in sedentary behavior during the workday (Baseline - week 8)
B: To assess the effectiveness of a 6-month primary care intervention to reduce diary hours of Sitting time in overweight and obese patients, as well as to increase their weekly caloric spend (Baseline-6-9-12 and 18 month)
C: Average steps per day (6 weeks)
D: Incidence of CHD and other lifestyle related diseases after ten years (2012)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of the Walking Intervention Walkadoo: A Randomized Controlled Pilot Trial in an Employee Population
Brief Summary: This study evaluates the product Walkadoo to determine whether it effectively increases walking behavior in healthy adults.


Options:
A: Change in sedentary behavior during the workday (Baseline - week 8)
B: change in physical activity (4 months)
C: Average steps per day (6 weeks)
D: sitting time (one week); self-reported context-specific sitting time (one week); standing time (one week); breaks from sitting (one week)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Identification and Intervention for Dementia in Elderly Africans (IDEA) Study: CST Trial
Brief Summary: This trials of cognitive stimulation therapy (CST) in Tanzania is part of the larger Identification and Intervention for Dementia in Elderly Africans (IDEA) study.

The overall aim of the IDEA study is to set up and evaluate sustainable programmes to facilitate diagnosis of, and therapy for, people with dementia led by local communities in sub-Saharan Africa. We aim seek to improve quality of life for people with dementia and their caregivers.

Within this trial of CST, we hypothesise that CST can significantly improve the quality of people with dementia and their carers living in Africa


Options:
A: World Health Organization Brief Quality of Life Scale (Baseline); World Health Organization Brief Quality of Life Scale (Immediately post-intervention)
B: Cognitive state evaluated through Mini-Mental State Examination (Pre-intervention); Change in cognitive state evaluated through Mini-Mental State Examination (6 months after the beginning of the intervention); Change in cognitive state evaluated through Mini-Mental State Examination (12 months after the beginning of the intervention); Cognitive performance evaluated through Montreal Cognitive Assessment (Pre-intervention); Change in cognitive performance evaluated through Montreal Cognitive Assessment (6 months after the beginning of the intervention); Change in cognitive performance evaluated through Montreal Cognitive Assessment (12 months after the beginning of the intervention)
C: N/A
D: Change from Baseline in the elderly participant's Cognition (Post-intervention assessment (week 13)); Change from Baseline in the elderly participant's Quality of Life (Post-intervention assessment (week 13)); Change from Baseline in the caregiver's overall health (Post-intervention assessment (week 13))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Abelmoschus Manihot for IgA Nephropathy: a Multicentre, Double-blind, Double-dummy, Randomized Controlled Trial
Brief Summary: -IgA nephropathy is the most common primary glomerular disease in China, Huangkui Capsule is a single medicament of traditional Chinese medicine consists of Abelmoschus manihot and has been widely used to treat kidney disease. The purpose of this study is to evaluate the safety and efficacy of Abelmoschus manihot for treating IgA nephropathy in large scale samples with long time take.


Options:
A: First occurrence of 40% decrease in eGFR from baseline (Baseline, until the first occurrence or 3 years); First occurrence of progression to continuous renal replacement (Until occurrence or 3 years); Death due to renal disease (Until occurrence or 3 years)
B: urinary protein loss whithin 24 hours (2-3years)
C: Change in 24-h proteinuria from baseline after treatment (Baseline(week 0), week 4, week 12, week 24, week 36, week 48)
D: ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months); ONTARGET. 3-fold Composite Endpoint of Doubling of Serum Creatinine, Progression to End Stage Renal Disease (ESRD) and All-cause Mortality in Diabetic Nephropathy Patients (56 months); TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Open-Label Study of Nivolumab Combined With Ipilimumab Versus Sunitinib Monotherapy in Subjects With Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma
Brief Summary: The purpose of this study is to compare the objective response rate, progression free survival and the overall survival of Nivolumab combined with Ipilimumab to Sunitinib monotherapy in patients with previously untreated Renal Cell Cancer.


Options:
A: Investigator-assessed Objective Response Rate(ORR) in Intermediate/Poor Risk Participants Per IRRC Using RECIST v1.1 (From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to June 2017, approximately 31 months)); Overall Survival (OS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC) (From the date of randomization to the date of death (assessed up to June 2017, approximately 31 months)); Progression-Free Survival (PFS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC) (From date of first dose to date of documented disease progression or death due to any cause, whichever occurs first (assessed up to June 2017, approximately 31 months))
B: Anti-tumor Activity as Measured by Median Progression Free Survival Time (24 Months)
C: progression-free rate (at 48 weeks post-treatment)
D: Progression free survival, PFS (This is defined as the time between date of randomisation and the first date of documented disease progression or date of death due to any cause.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Open-Label Study of Nivolumab Combined With Ipilimumab Versus Sunitinib Monotherapy in Subjects With Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma
Brief Summary: The purpose of this study is to compare the objective response rate, progression free survival and the overall survival of Nivolumab combined with Ipilimumab to Sunitinib monotherapy in patients with previously untreated Renal Cell Cancer.


Options:
A: Phase 1b: Number of Participants With Dose-limiting Toxicity (DLT) (First dose of study drug (Cycle 1 Day 1) to end of first 4 weeks of therapy (Cycle 1)); Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 (RP2) Dose (First dose of study drug (Cycle 1 Day 1) to end of Cycle 2 (1 cycle = 28 days/4 weeks)); Phase 2: Progression-Free Survival (PFS) (Date of randomization into Phase 2 (Cycle 1 Day 1) to the date of first documentation of disease progression or death (whichever occurred first), assessed up to data cutoff date (13 Jun 2014), up to approximately 2 years and 3 months)
B: Investigator-assessed Objective Response Rate(ORR) in Intermediate/Poor Risk Participants Per IRRC Using RECIST v1.1 (From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to June 2017, approximately 31 months)); Overall Survival (OS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC) (From the date of randomization to the date of death (assessed up to June 2017, approximately 31 months)); Progression-Free Survival (PFS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC) (From date of first dose to date of documented disease progression or death due to any cause, whichever occurs first (assessed up to June 2017, approximately 31 months))
C: Progression Free Survival First-Line (PFS 1-L) (based on radiological assessments every 3 months until disease progression, start of another antineoplastic therapy or for any other reason up to 35 months)
D: Progression Free Survival (PFS) (From randomization to disease progression or death (up to approximately 2 years))

Answer: B