TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: TAKE-IT: Teen Adherence in Kidney Transplant Effectiveness of Intervention Trial
Brief Summary: The broad aim of the proposed study is to improve medication adherence in adolescent kidney transplant recipients. The investigators hypothesize that a multi-component intervention will improve medication adherence in the adolescent kidney transplant population. The specific aims are to determine, in a randomized clinical trial, the efficacy of a structured, multi-component intervention in improving adherence to anti-rejection medications and graft outcomes, and to identify characteristics of healthcare systems that are independently associated with adherence.


Options:
A: Taking Adherence (12 months); Timing Adherence (12 months)
B: Medication Adherence (six months)
C: medication adherence (5 months)
D: basal assessment of adherence with immunosuppressive medication scale (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: TAKE-IT: Teen Adherence in Kidney Transplant Effectiveness of Intervention Trial
Brief Summary: The broad aim of the proposed study is to improve medication adherence in adolescent kidney transplant recipients. The investigators hypothesize that a multi-component intervention will improve medication adherence in the adolescent kidney transplant population. The specific aims are to determine, in a randomized clinical trial, the efficacy of a structured, multi-component intervention in improving adherence to anti-rejection medications and graft outcomes, and to identify characteristics of healthcare systems that are independently associated with adherence.


Options:
A: Knowledge of increased risk donor kidney transplants (1 week)
B: Taking Adherence (12 months); Timing Adherence (12 months)
C: Dialysis Within 7 Days (From start of AKI to 7 days later); Death (7 days of randomization); Relative Maximum Change in Creatinine (7 days of randomization)
D: Composite clinical outcome (1 year (plus 12 weeks for complete follow-up of technique failure))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: TAKE-IT: Teen Adherence in Kidney Transplant Effectiveness of Intervention Trial
Brief Summary: The broad aim of the proposed study is to improve medication adherence in adolescent kidney transplant recipients. The investigators hypothesize that a multi-component intervention will improve medication adherence in the adolescent kidney transplant population. The specific aims are to determine, in a randomized clinical trial, the efficacy of a structured, multi-component intervention in improving adherence to anti-rejection medications and graft outcomes, and to identify characteristics of healthcare systems that are independently associated with adherence.


Options:
A: Change in Anxiety and Depression (HADS) scores from baseline (Participants will be assessed at two time points: [T1] Baseline and [T2] 3 months post-randomization)
B: Taking Adherence (12 months); Timing Adherence (12 months)
C: Referral for Kidney Transplantation (One Year)
D: Deceased Donor Kidney Transplant (DDKT) and Living Donor Kidney Transplant (DDKT) Knowledge (9 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Open Label Extension Study of 8 mg PEG-uricase in Subjects Who Completed Protocols C0405 or C0406 for Symptomatic Gout
Brief Summary: This is an open-label extension phase of two double-blind, placebo-controled Phase 3 protocols evaluating PEG-uricase in the treatment of hyperuricemic subjects with symptomatic gout. The purpose of this study is to provide a continuation of treatment to subjects completing the double-blind studies and obtain long-term safety and efficacy data.


Options:
A: Uric Acid (mg/dL) (Week 13, Week 25, Week 53, Week 101)
B: Percentage of Subjects Whose Serum Urate Level is <6.0 Milligrams Per Deciliter (mg/dL) at the Final Visit. (Last Visit on treatment (up to 6 months))
C: Plasma Uric Acid (PUA) Responder (Months 3 and 6)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Low Molecular Weight Heparin (Enoxaparin Sodium) and Standard Unfractionated Heparin for Hemodialysis Anticoagulation
Brief Summary: Low-molecular weight heparins (LMWHs) as well as Unfractionated heparin (UFH) is used as anticoagulation during hemodialysis (HD) therapy. In this study the investigators have compared clinical efficacy and safety of LMWH and UFH, and their effect on lipid profile.


Options:
A: Levels of osteoprotegerin after administration of UFH or LMWH used as anticoagulant therapy for hemodialysis (during and after dialysis sessions)
B: Rate of major, clinically important non-major or minor bleeding (26 weeks)
C: Fibrin/clot formation in the dialyzer and Hemorrhage in Dialysis by visual inspection (3 month)
D: Ischemic stroke or systemic embolism (efficacy) (Up to 72 months); Intracranial bleeding (including hemorrhagic stroke) and fatal bleeding (safety) (Up to 72 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Use of Transcranial Direct Current Stimulation in the Recovery of Postural Control in Stroke
Brief Summary: This study investigates if transcranial Direct Current Stimulation (tDCS) is effective in the recovery of postural control in stroke rehabilitation.


Options:
A: Box and Block Test; Data Collected = Number of Blocks Moved (Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)); Fugl-Meyer Upper Extremity Motor Test (Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)); Fractionated Reaction Time (Baseline/pretest; posttest given between days 17-22 (posttest days 3-8))
B: Change in Modified Rivermead Mobility Index Score (12 weeks)
C: Trunk Impairment Scale (reporting a change on trunk performance at baseline, after 1 month and after two months) (baseline, after 1 month, After 2 months); Rivermead Motor Assessment Battery (RMAB) (reporting a change on motricity of gross function, arm, leg and trunk at baseline, after 1 month and after two months) (baseline, after 1 month, After 2 months); Tinetti Test (reporting a change on balance and gait tasks at baseline, after 1 month and after two months) (baseline, after 1 month, After 2 months)
D: Behavioural Inattention Test (BIT) (Assessed at the recruitment interview (week 0) and at the exit interview (8 weeks after the intervention)); Neglect Test Battery (Assessed at 2 separate pre-intervention baseline sessions at least 1 week apart. Re-assessed following the intervention at intervals of 1, 2, 4 and 8 weeks.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Use of Transcranial Direct Current Stimulation in the Recovery of Postural Control in Stroke
Brief Summary: This study investigates if transcranial Direct Current Stimulation (tDCS) is effective in the recovery of postural control in stroke rehabilitation.


Options:
A: Change scores of Fugl-Meyer Assessment (FMA) (Baseline, 2 weeks, 4 weeks, 16 weeks, and 28 weeks); Change scores of Wolf Motor Function Test (WMFT) (Baseline, 2 weeks, and 4 weeks); Change scores of Motor Activity Log (MAL) (Baseline, 2 weeks, and 4 weeks, 16 weeks, and 28 weeks); Change scores of Stroke Impact Scale Version 3.0 (SIS 3.0) (Baseline, 2 weeks, and 4 weeks, 16 weeks, and 28 weeks); Change scores of Revised Nottingham Sensory Assessment (rNSA) (Baseline, and 4 weeks)
B: Upper Extremity Component of Fugl-Meyer Assessment (week 0, week 2, week 4)
C: Trunk Impairment Scale (reporting a change on trunk performance at baseline, after 1 month and after two months) (baseline, after 1 month, After 2 months); Rivermead Motor Assessment Battery (RMAB) (reporting a change on motricity of gross function, arm, leg and trunk at baseline, after 1 month and after two months) (baseline, after 1 month, After 2 months); Tinetti Test (reporting a change on balance and gait tasks at baseline, after 1 month and after two months) (baseline, after 1 month, After 2 months)
D: maximum voluntary isometric strength of knee extensors (2 hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Diagnostic Value of 3-T MRI in Suspected Prostate Cancer
Brief Summary: The purpose of the study is to evaluate the usefulness of 3-T magnetic resonance imaging (MRI) in the evaluation of suspected prostate cancer. Men with suspected prostate cancer based on serum prostate-specific antigen antigen (PSA) value are included. Men are randomized to pre-biopsy MRI or no MRI groups in ratio 1:1. Standard transrectal ultrasound guided biopsies will be taken in addition to extra biopsies from lesions suspicious based on MRI evaluation. Hypothesis is that more prostate cancers will be found after MRI evaluation.


Options:
A: Detection of "clinically significant cancer" (using definition A, i.e. Gleason ≥7 cancers) in at least one core of SB or TB. (Between 1 and 4 months after the enrollment)
B: Number of Prostate Cancer Diagnoses in MRI and no MRI Groups (at the end of the study (up to 1 year))
C: Proportion of men with clinically significant detected (When histology results available, at an expected average of 30 days post-biopsy)
D: Safety of multiparametric magnetic resonance imaging (MP-MRI); Recruitment; Proportion of men who could safely avoid biopsy as determined by specificity and negative predictive values; Proportion of men correctly identified by MP-MRI to have clinically significant prostate cancer as determined by sensitivity and positive predictive values

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Nonpharmacologic Management of Challenging Behaviors in Veterans With Dementia
Brief Summary: The Tailored Activity Program - Veterans Administration is a Phase III efficacy trial designed to reduce behavioral symptoms in Veterans with dementia living with their caregivers in the community. The study uses a randomized two group parallel design with 160 diverse Veterans and caregivers. The experimental group receives a transformative patient-centric intervention designed to reduce the burden of behavioral symptoms in Veterans with dementia. An occupational therapist conducts an assessment to identify a Veteran's preserved capabilities, deficit areas, previous roles, habits, and interests to develop activities tailored to the Veteran. Family caregivers are then trained to incorporate activities into daily care. The attention-control group receives bi-monthly telephone contact where education on topics relevant to dementia is provided to caregivers. Key outcomes include reduced frequency and severity of behavioral symptoms using the 12-item Neuropsychiatric Inventory (primary endpoint), reduced caregiver burden, enhanced skill acquisition, efficacy using activities, and time spent providing care at 4 months; and long-term effects (8 months) on the Veteran's quality of life and frequency and severity of behavioral symptoms, and caregiver use of activities. The programs' impact of Veterans Administration cost is also examined. Study precision will be increased through face-to-face research team trainings with procedural manuals and review of audio-taped interviews and intervention sessions.


Options:
A: The Neuropsychiatric Inventory (NPI). Measures the Frequency and Severity of Behavioral Symptoms in Dementia. (Baseline, 4 month (short-term follow-up), 8 month (long-term))
B: Behavioral occurrence; Care recipient depressive mood; Caregiver upset
C: Admittance to nursing home care (24 months)
D: Frequency by severity of Agitated and Aggressive Behavior in person with dementia (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating the Effectiveness of an In-home Self-management Intervention to Prevent Psychological Distress in Frail Older People Living in the Community
Brief Summary: The main objectives of this study are:

1. an effect evaluation of an in-home multicomponent cognitive behavioural program on concerns about falling and related avoidance of activity (primary outcomes), as well as disability, fall incidents (secondary outcomes) and several additional outcomes in frail community-dwelling older people,
2. a process evaluation of the feasibility of the program, with the following main outcomes: population reached, performance according to protocol, exposure and engagement, opinion on the program of participants and facilitators, perceived benefit or achievement, and experienced barriers and potential solutions, and
3. an economical evaluation on the impact of the program on healthcare utilization and related costs.


Options:
A: Change from baseline in Geriatric Depression Scale (GDS) (Pre-treatment, posttreatment (expected average of 9 months after protreatment), 6- and 12-months follow-up)
B: Primary outcomes are number of falls and falls rates as well as number and incidence of injurious falls measured by monthly fall calendars (24 months)
C: First Adjudicated Serious Fall-Related Injury (Enrollment through last completed follow-up or death interview (max 44 months))
D: concerns about falling (baseline, 5 months and 12 months); avoidance of activities due concerns about falling (baseline, 5 months and 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Emergency Department-Based Palliative Care for Advanced Cancer Patients
Brief Summary: The purpose of this study is to: 1) identify the palliative care needs of Emergency Department patients with advanced cancer, and determine if these needs can be rapidly assessed in the ED; 2) determine whether early palliative care consultation improves survival, quality of life and other burdensome symptoms and decreases utilization as compared to usual care.


Options:
A: Change from baseline in depression symptoms on the HADS-D and PHQ-9 at day 90. (Baseline, Day 90.); Change from baseline in satisfaction with care on the FAMCARE-patient scale at days Days 45, 90, 120 and 180. (Baseline, Days 45, 90, 120 and 180.); Descriptive results about feasibility of the study. (Average duration in minutes of each intervention session (both regarding Palliative Care consultation and Psychological session); number of non-attendance to the interventions (absences); reasons reported by patients for missing.)
B: Quality of life as measured by Functional Assessment of Cancer Therapy-Palliative care version (FACT-Pal) at baseline, one month, and every three months thereafter (Baseline, one month, every three months); Symptom management as measured by Edmunton Symptom Assessment Scale at baseline, one month, and every three months thereafter (Baseline, one month, every three months); Health care utilization by a chart review of days in hospital, ICU, ER visits at baseline, one month, and every three months thereafter (Baseline, one month, every three months); Correlate preferences for care and care received as measured by After Death Bereaved Family Member Interview with a family member of the deceased (Baseline, one month, every three months)
C: Quality of life and quality of mental health at 6 weeks and 12 weeks as compared from baseline (at baseline, 6 weeks and 12 weeks)
D: Assess the impact of early integration with palliative care on QOL in patients with advanced NSCLC. (3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Double-dummy, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy After Twelve Weeks of Treatment, Compared to Placebo and Etanercept, and to Assess the Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
Brief Summary: This study will assess the safety and efficacy of secukinumab compared to placebo and etanercept in patients that have moderate to severe, chronic, plaque-type psoriasis.


Options:
A: Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16 (Week 16)
B: Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) . (12 wks); Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12 (12 wks)
C: Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 (12 weeks); Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 (12 weeks); Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12 (12 Weeks)
D: Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 at Week 12 (0-12 weeks); Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 (0 - 12 Weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Double-dummy, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy After Twelve Weeks of Treatment, Compared to Placebo and Etanercept, and to Assess the Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
Brief Summary: This study will assess the safety and efficacy of secukinumab compared to placebo and etanercept in patients that have moderate to severe, chronic, plaque-type psoriasis.


Options:
A: Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) . (12 wks); Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12 (12 wks)
B: Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12 (12 weeks)
C: Psoriasis Area and Severity Index (PASI) 75 Response and Investigators' Global Assessment (IGA) Mod 2011 0 or 1 Response (12 weeks)
D: Number of Participants With Psoriasis Area and Severity Index (PASI) Score of 75 Percent or Above at Week 12 (Week 0 to Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Double-dummy, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy After Twelve Weeks of Treatment, Compared to Placebo and Etanercept, and to Assess the Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
Brief Summary: This study will assess the safety and efficacy of secukinumab compared to placebo and etanercept in patients that have moderate to severe, chronic, plaque-type psoriasis.


Options:
A: Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 (Week 12); Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 by Anti-adalimumab Antibody Status (Week 12)
B: Number of Patients Achieving "Clear" or "Almost Clear" on Physician Global Assessment (PGA) of Psoriasis (12 weeks)
C: Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) . (12 wks); Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12 (12 wks)
D: Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 16 (Week 16)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Double-dummy, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy After Twelve Weeks of Treatment, Compared to Placebo and Etanercept, and to Assess the Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
Brief Summary: This study will assess the safety and efficacy of secukinumab compared to placebo and etanercept in patients that have moderate to severe, chronic, plaque-type psoriasis.


Options:
A: Subject incidence of serious adverse events, including serious infections, non-melanoma skin cancer, and all malignancies, and all adverse events.
B: Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 (Week 12); Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 by Anti-adalimumab Antibody Status (Week 12)
C: Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) . (12 wks); Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12 (12 wks)
D: Percentage of Participants With Physician's Global Assessment (PGA) Score of "Clear" or "Almost Clear" at Week 16 (Week 16); Percentage of Participants Achieving at Least a 75% Reduction in PASI (PASI75) at Week 16 (Week 16)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Double-dummy, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy After Twelve Weeks of Treatment, Compared to Placebo and Etanercept, and to Assess the Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
Brief Summary: This study will assess the safety and efficacy of secukinumab compared to placebo and etanercept in patients that have moderate to severe, chronic, plaque-type psoriasis.


Options:
A: Number of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA) (Week 12); Number of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI) (Week 12)
B: Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) . (12 wks); Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12 (12 wks)
C: Aortic Vascular Inflammation as Measured by FDG-PET/CT (baseline, 12 weeks)
D: Achievement of ≥90% Reduction From Baseline PASI Score (PASI90) at Week 12 (Baseline and Week 12)

Answer: B