TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Mixed Methods Investigation of Brief Mindfulness Training and Self-injury Attentional Bias Among Self-injuring Adolescents
Brief Summary: My study will employ a convergent mixed methods two-arm parallel randomized controlled design. The qualitative strand will primarily rely on semi-structured interview procedures to answer the following questions: (1) How do adolescents perceive and experience the phenomenon of nonsuicidal self-injury (NSSI)? (2) What do adolescents believe needs to be done to address NSSI? The quantitative strand will primarily rely on clinical interview data, self-report measures, and an experimental task protocol to answer the following question: What is the impact of a brief mindfulness induction (versus a control condition) on self-injury attentional bias among self-injuring adolescents?


Options:
A: Changes in Stages of Change Questionnaire, which measures motivation (3 months); Changes in Reasons for Living Inventory (3 months); Changes in State Hope Scale (3 months); Changes in Interpersonal Needs Questionnaire, which measures constructs of thwarted belongingness and perceived burdensomeness. (3 months); Changes in Beck Scale for Suicide Ideation (3 months); Suicide Attempt Self-Injury Count (3 months)
B: The primary clinical endpoint is the duration (in days) of a suicide reattempt-free follow-up period (12 months)
C: Change in self-injury attentional bias as measured by a Dot Probe Paradigm (The Dot Probe Paradigm will be administered immediately preceding the mindfulness or control conditions and immediately following the mindfulness or control conditions)
D: Social Processing (Cyberball) fMRI Task: fMRI Responses (Pre-treatment (baseline) and post-treatment (up to 2 weeks)); Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior (One week before tDCS (baseline), two weeks during tDCS (during tDCS), one week post-tDCS (post-tDCS)); Self Injurious Thoughts and Behaviors Inventory Part 1 (Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline)); Ecological Momentary Assessment (EMA): NSSI Urges and Behavior (One week before tDCS (baseline), two weeks during tDCS (during tDCS), one week post-tDCS (post-tDCS)); Self Injurious Thoughts and Behaviors Inventory Part 2 (pre-treatment (baseline) and post-treatment (up to 2 weeks)); Self Injurious Thoughts and Behaviors Inventory Part 3 (Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline)); Self Injurious Thoughts and Behaviors Inventory Part 4 (Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Mixed Methods Investigation of Brief Mindfulness Training and Self-injury Attentional Bias Among Self-injuring Adolescents
Brief Summary: My study will employ a convergent mixed methods two-arm parallel randomized controlled design. The qualitative strand will primarily rely on semi-structured interview procedures to answer the following questions: (1) How do adolescents perceive and experience the phenomenon of nonsuicidal self-injury (NSSI)? (2) What do adolescents believe needs to be done to address NSSI? The quantitative strand will primarily rely on clinical interview data, self-report measures, and an experimental task protocol to answer the following question: What is the impact of a brief mindfulness induction (versus a control condition) on self-injury attentional bias among self-injuring adolescents?


Options:
A: Change in self-injury attentional bias as measured by a Dot Probe Paradigm (The Dot Probe Paradigm will be administered immediately preceding the mindfulness or control conditions and immediately following the mindfulness or control conditions)
B: Suicide Attempt Self-Injury Interview (SASII) (4 months, 8 months and 12 months)
C: Acceptability- attendance rates (Five weeks); Safety- adverse experiences (Five weeks); Feasibility - completion rate of assessments (Five weeks)
D: Existence of a suicide (6 months); Existence of a suicide (13 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Behavioral Activation for Dementia Caregivers: Scheduling Pleasant Events and Enhancing Communications
Brief Summary: This project was designed to test a model targeted intervention for dementia caregivers telephone program consisting of both psychoeducation and behavioral activation components to reduce the burden of caregivers. The program is delivered by telephone to increase accessibility and sustainability for caregivers.


Options:
A: Depressive Symptoms (Change from baseline through study completion, an average of about 5 months)
B: Perceived stress (every 3 months (between 0 and 6 months))
C: Mental Component Summary of the General Health Questionaires Short Form 12 (SF-12) (3 months)
D: Beck Depression Inventory II (Beck, Steer & Brown, 1996) (Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention); Primary Outcome: Beck Depression Inventory II (Beck, Steer & Brown, 1996) (Post-intervention, assessed 4-14 days after final intervention session.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Behavioral Activation for Dementia Caregivers: Scheduling Pleasant Events and Enhancing Communications
Brief Summary: This project was designed to test a model targeted intervention for dementia caregivers telephone program consisting of both psychoeducation and behavioral activation components to reduce the burden of caregivers. The program is delivered by telephone to increase accessibility and sustainability for caregivers.


Options:
A: Depressive Symptoms (Change from baseline through study completion, an average of about 5 months)
B: Change from Baseline in Health Related Quality of Life at One, Three and Six Months (One, three and six months)
C: Effects of the WeCareAdvisor Tool on Caregiver Upset (4 weeks); Effect of the WeCareAdvisor Tool on Caregiver Confidence (4 weeks)
D: Change from baseline in subjective burden using the Zarit Burden Interview (ZBI) (Baseline, Month 3, Month 6)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Child Mental Health Problems in Southeastern Europe - Adapt, Optimize, Test and Extend Parenting for Lifelong Health
Brief Summary: The aim of this study is to develop an adapted version of a low-cost parenting program (Parenting for Lifelong Health for Young Children, PLH) to the specific needs of families in three low- and middle income countries (LMICs) in southeastern Europe (Romania, FYR of Macedonia and Republic of Moldova). The investigators want systematically evaluate key barriers and facilitators at the local, national and international levels that impact prevention of child behavioral disorders.

The investigators will prepare training materials adapted to Romanian, Moldovian, Albanian, Macedonian, and Russian and train facilitators and mentor coaches in the delivery of the PLH program in each country. Also, a pre-post study will be conducted testing the feasibility of the program and the evaluation and implementation methods with 40 families at each country site. This includes examination of outcomes related to implementation fidelity, program acceptability, and preliminary program effectiveness on reducing child behavior problems and associated risk factors.

This feasibility study is part of a larger implementation project. Developed on the MOST framework (the multiphase optimization strategy), this specific study will reflect the implementation of the first phase. There are two more phases to come: the Parenting for Lifelong Health for Young Children program will be optimized within the three countries by determining which components are most efficacious and cost-effective (phase 2). The optimized PLH programs will be tested in three RCTS in the countries (phase 3).


Options:
A: Change in Child Protection (Baseline, 12 months, 24 months); Change in Exposure to Child Abuse (Baseline, 12 months, 24 months)
B: Change in Grief Intensity (Baseline, 2 months post-intervention); Change in Mental Health (Baseline, 2 months post-intervention)
C: Change in levels of externalizing problem behavior in children: Child Behavior Checklist (CBCL) 11/2-5 and 6-18, parent-report, Externalizing Scale (Pre-Post (approximately 16 - 20 weeks after pre-assessment)); Change in Prevalence of Oppositional Defiant Disorder (ODD) and Conduct Disorder (CD)) in children: The Mini International Neuropsychiatric Interview for Children and Adolescents - Parent Version; MINI-KID-P Clinician-rated (Pre-Post (approximately 16 - 20 weeks after pre-assessment))
D: Mental health symptoms (6 weeks); Idiographic problems (6 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Alirocumab for Thin-cap fIbroatheroma in Patients With Coronary Artery Disease Estimated by Optical Coherence Tomography: Single Center, Randomized, Open-label, Trial
Brief Summary: the purpose of this study is to show that alirocumab with statin therapy have a s tronger stabilizing effect on vulnerable plaque in coronary artery disease than statin alone administration


Options:
A: Number of Participants With Adverse Events (52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; actual median duration of treatment in the All-IP period was 46.9 months.)
B: the change in fibrous cap thickness (9 month)
C: Percent Change From Baseline in LDL-C at Week 52 (Baseline and Week 52)
D: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis (From Baseline to Week 52)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Open-label Parallel-group Trial is to Analyze the Efficacy and the Efficiency of the Social-Local-Mobile (So-Lo-Mo) Intervention Applied to the Smoking Cessation Process.
Brief Summary: This is a randomized open-label parallel-group trial. 240 subjects will be recruited during 8 months and a 12 months follow-up will be carried out for each one of them. The sample will split in two groups: control group (n=120) who will receive usual psycho-pharmacological therapy and the intervention group (n=120) who will receive usual therapy plus So-Lo-Mo app.


Options:
A: Efficacy: Smoking abstinence rate (1 year); Efficiency: Incremental Cost-Effectiveness Ratio (1 year)
B: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)
C: Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking (Week 15 - 24)
D: Smoking Abstinence (3 months); Smoking Abstinence (6 months); Smoking Abstinence (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Adjuvant Therapy With Pembrolizumab Versus Placebo in Resected High-risk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study (KEYNOTE-716)
Brief Summary: This 2-part study will evaluate the safety and efficacy of pembrolizumab (MK-3475) compared to placebo in participants with surgically resected high-risk Stage II melanoma. Participants in Part 1 will receive either pembrolizumab or placebo in a double-blind design every 3 weeks (Q3W) for up to 17 cycles/\~1 year (each cycle = 21 days). Participants who complete the initial treatment of 17 cycles of pembrolizumab in Part 1 and experience disease recurrence may be eligible for re-challenge with pembrolizumab at the same dose and schedule of 200 mg Q3W (21-day cycles) for up to 35 cycles (up to \~2 years) in Part 2 in an open label design. Participants who complete the initial treatment of placebo and experience disease recurrence may be eligible to switch over to pembrolizumab 200 mg Q3W (21-day cycles) for up to 35 cycles (up to \~2 years) in Part 2 in an open label design. The primary hypothesis of this study is that pembrolizumab increases recurrence-free survival (RFS) compared to placebo.

Per protocol, response/ progression or adverse events (AEs) during re-challenge/switch-over in Part 2 will not be counted towards the RFS outcome measure or safety outcome measures respectively.


Options:
A: Recurrence-free Survival (RFS) (Up to ~32.7 months)
B: Major Pathologic Response Rate (MPR) (Every 6 weeks from start of study treatment, up to 52 weeks)
C: Progression-free Survival (PFS) as Assessed by the Investigator (Time interval between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause (up to 9.9 months)); Progression-free Survival (PFS) as Assessed by an Independent Radiologist: Randomized Phase (Time interval between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause (up to 9.9 months))
D: Safety of patients as measured by the adherence to the timelines in the study protocol (6 months); Feasability of patients as measured by the adherence to the timelines in the study protocol (6 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Memantine for the Treatment of Social Deficits in Youth with Disorders of Impaired Social Interactions: a Randomized-controlled Trial
Brief Summary: This study is a 12-week randomized-controlled trial of memantine hydrochloride (Namenda) for the treatment of social impairment in youth with Non-Verbal Learning Disorder, High-Functioning Autism Spectrum Disorder, and related conditions. Eligible participants will be males and females ages 8-18.

This study consists of up to 6 visits to Massachusetts General Hospital.


Options:
A: Clinical Global Impression-Improvement Scale (CGI-I) (Baseline to 12 weeks)
B: Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score (Week 8)
C: Clinical Global Improvement (Week 12)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Memantine for the Treatment of Social Deficits in Youth with Disorders of Impaired Social Interactions: a Randomized-controlled Trial
Brief Summary: This study is a 12-week randomized-controlled trial of memantine hydrochloride (Namenda) for the treatment of social impairment in youth with Non-Verbal Learning Disorder, High-Functioning Autism Spectrum Disorder, and related conditions. Eligible participants will be males and females ages 8-18.

This study consists of up to 6 visits to Massachusetts General Hospital.


Options:
A: Aberrant Behavior Checklist- 2nd Edition (ABC-2): Irritability subscale raw score (Baseline to Week 12)
B: Clinical Global Impression-Improvement Scale (CGI-I) (Baseline to 12 weeks)
C: N/A
D: Change From Baseline in Aberrant Behavior Checklist Irritability Subscale (ABC-I) (Baseline and 7 days.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Memantine for the Treatment of Social Deficits in Youth with Disorders of Impaired Social Interactions: a Randomized-controlled Trial
Brief Summary: This study is a 12-week randomized-controlled trial of memantine hydrochloride (Namenda) for the treatment of social impairment in youth with Non-Verbal Learning Disorder, High-Functioning Autism Spectrum Disorder, and related conditions. Eligible participants will be males and females ages 8-18.

This study consists of up to 6 visits to Massachusetts General Hospital.


Options:
A: Change in Clinical Global Impressions (CGI) Global Improvement (Change from Baseline at 8 Weeks); Change in Clinical Global Impressions (CGI) Global Improvement (Change from Open-Label Baseline at 8 Weeks); Change in Lethargy Subscale of the Aberrant Behavior Checklist (ABC) (Change from Baseline at 8 Weeks.); Change in Lethargy Subscale of the Aberrant Behavior Checklist (ABC) (Change from Open-Label Baseline at 8 Weeks)
B: Clinical Global Impression-Improvement Scale (CGI-I) (Baseline to 12 weeks)
C: Aberrant Behavior Checklist - Social Withdrawal Subscale (Phase 1 - Week 4 and 12, Phase 2 - Week 4 and 8)
D: The primary measure will be a global composite derived by calculating the z scores on each measure other than CGI from published norms (or from the baseline descriptives, then averaging the z scores of the various outcome measures for each individual. (Baseline, weeks 2, 4, 6, 8, 10,12, and 14.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Memantine for the Treatment of Social Deficits in Youth with Disorders of Impaired Social Interactions: a Randomized-controlled Trial
Brief Summary: This study is a 12-week randomized-controlled trial of memantine hydrochloride (Namenda) for the treatment of social impairment in youth with Non-Verbal Learning Disorder, High-Functioning Autism Spectrum Disorder, and related conditions. Eligible participants will be males and females ages 8-18.

This study consists of up to 6 visits to Massachusetts General Hospital.


Options:
A: Social Responsiveness Scale (SRS) Change (Completed at Baseline and Week 11); Social Responsiveness Scale (SRS) at Follow-Up (Completed at Week 22)
B: Extent of Absorption of Memantine (Part One) (Baseline to 144 hours. Measurements were taken 0 (predose), 4, 8, 24, 30, 48, 96 and 144 hours post-dose); Change in Total Raw Score of Social Responsiveness Scale (From Baseline to Week 12)
C: Treatment Responder (12 Weeks (from Baseline [Week 0] to Endpoint [Week 12]))
D: Clinical Global Impression-Improvement Scale (CGI-I) (Baseline to 12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Momentum Trial: The Efficacy of Using a Smartphone Application to Support Shared Decision Making Through Patient Activation in People With a Diagnosis of Schizophrenia in Outpatient Treatment Settings
Brief Summary: This study investigates the effects of using a smartphone app to support shared decision making (SDM) for people with schizophrenia-spectrum disorders in an outpatient treatment setting. Patients are randomized to specialized early intervention treatment with the Momentum app or without the app. The primary objective is to investigate the effect of the app on patient activation 6 months after baseline. Secondary outcomes are positive and negative symptoms, level of functioning; working alliance; self-efficacy; treatment satisfaction; hope; level of SDM; and perceived efficacy in patient-provider interaction. Explorative outcomes are self-perceived usefulness of the Momentum app.


Options:
A: Time to First Treatment Failure (From date of randomization up to Month 15); Percentage of Participants in Each Event Category of First Treatment Failure (From date of randomization up to Month 15)
B: Change in patient activation measured with the Consumer Health Activation Index - Mental Health (CHAI-MH) (baseline, 3 months and end of intervention (6 months))
C: changes in cognitive insight over time (baseline, 3,6 and 12 month)
D: Patient Activation (Baseline, 30days, 90days); Patient Self-Management (Baseline, 30days, 90days); Engagement in mental health care (Six months following last research interview); Retention in mental health treatment (Six months following last research interview)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-Center Study of Sensory Stimulation to Improve Brain Function (Overture Study)
Brief Summary: The Overture Study is a randomized, controlled, single-blind multi-center clinical trial using the GammaSense Stimulation system to study safety, tolerability, and efficacy in people with mild to moderate cognitive impairment.


Options:
A: Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog) (Quarterly over 6 months)
B: Change in the Quality of Life in Alzheimer's Disease (QOL-AD) Scale (Baseline and 1 month)
C: Change From Baseline in Nighttime Total Sleep Time (Baseline, 14 days follow-up)
D: Change from baseline to Week 24 in the standard 11-item total score from the 13-item Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog). (Week 4, 12, and 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase III Trial of Platinum Chemotherapy Plus Paclitaxel With Bevacizumab and Atezolizumab Versus Platinum Chemotherapy Plus Paclitaxel and Bevacizumab in Metastatic (Stage IVB), Persistent, or Recurrent Carcinoma of the Cervix
Brief Summary: The study will integrate the efficacy of combining the anti programmed death-ligand 1 (anti-PD-L1) agent atezolizumab with the current standard of care in Stage IVB , persistent or recurrent carcinoma of the cervix, namely cisplatin or carboplatin/paclitaxel/bevacizumab. It will be explored the combination of bevacizumab plus atezolizumab, with no patient selection based on PD-L1 expression, allowing an all-comer assessment of atezolizumab activity.

The study is a randomized open label phase III trial to investigate the impact of atezolizumab in combination with bevacizumab and cisplatin or carboplatin /paclitaxel chemotherapy on overall survival and will employ the intent to treat principle, and random assignment to one of the 2 arms will be balanced according to disease histology (squamous cell carcinoma vs adenocarcinoma), prior platinum therapy as a radiation sensitizer (no prior cis-Radiotherapy (RT) versus prior cis-RT) and chemotherapy backbone (cisplatin vs carboplatin).

This trial will be run in an open label design due to the following considerations: the control arm is the standard of care for women diagnosed with metastatic, persistant or recurrent cervical cancer because of its impact on overall survival and the primary endpoint of the study is overall survival (OS), so blinding is not needed to ensure a robust assessment.


Options:
A: overall survival (During the study conduct)
B: Anti-tumor Activity as Measured by Surviving Progression-free (Progression-free survival at 6 months)
C: Progression-free survival (48 months); Overall survival (48 months)
D: Overall Survival (From entry into the study to death or the date of last contact, assessed up to 5 years); Progression-free Survival (From study entry until disease progression, death or date of last contact, assessed up to 5 years (During treatment: every 3 weeks if by physical exam, every 6 weeks by CXR, CT or MRI. In follow-up: quarterly for 2 years then semi-annually for 3 years)); Tumor Response (Every cycle (if assessed by physical exam), every other cycle (if assessed by imaging), after the final cycle, then every 3 months x 2 years, then every 6 months x 3 years up to 5 years.); To Determine and Compare the Frequency and Severity of Adverse Events as Assessed by CTCAE Version 3.0 for the Regimens Administered on This Study. (From date of enrollment until 30 days after treatment completion)

Answer: C