TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Testosterone Replacement to Augment Lifestyle Therapy in Obese Older Veterans
Brief Summary: The prevalence of obesity in Veterans is greater than in the general population, and even more so among users of the VA Health Care System. In addition, the population of obese older Veterans is rapidly increasing as more baby boomers become senior citizens. In older Veterans, obesity exacerbates the age- related decline in physical function and causes frailty which predisposes to admission to a VA chronic care facility. However, the optimal clinical approach to obesity in older adults is controversial because of the concern that weight loss therapy could be harmful by aggravating the age-related loss of muscle mass and bone mass. In fact, the MOVE (Managing Overweight/Obese Veterans) program does not have any guidelines for eligible Veterans if they are 70 or older. It is possible that the addition of testosterone replacement to lifestyle therapy will preserve muscle mass and bone mass and reverse frailty in obese older Veterans and thus prevent their loss of independence and decrease demand for VA health care services.


Options:
A: Sexual Function Trial - Change in Psychosexual Daily Questionnaire Question 4 (PDQ-Q4) From Baseline to Month 12 (1 year (change from baseline to month 3, 6, 9 and 12)); Physical Function Trial - The 6-Minute Walk Test - no./Total no. (%) (1 year (Number of participants who increased walk distance > or = 50 meters, change from baseline to month 3, 6, 9 and 12)); Vitality Trial - Increase in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score Greater Than or Equal to 4 - no./Total no. (%) (1 year (Number of participants who increased FACIT-Fatigue score > or = to 4, change from baseline to month 3, 6, 9 and 12)); Cardiovascular Trial - Assess Impact of Testosterone Treatment in Older Men on Noncalcified Plaque Volume (1 year (change in plaque volume measurement from baseline to month 12)); Bone Trial - Volumetric Bone Mineral Density (BMD) of Spine Trabecular Bone by Quantitative Computed Tomography (QCT) in Older Men With Low Testosterone (1 year (QCT measurement of BMD change between baseline and month 12)); Cognitive Function Trial - Delayed Paragraph Recall Wechsler Memory Scale Revised Logical Memory II (WMS-R LMII) (1 year (change from baseline to month 6 and month 12)); Anemia Trial - Effect of Testosterone on Hemoglobin Levels - Unexplained Anemia (1 year (change in hemoglobin g/dL from baseline to month 3, 6, 9 and 12))
B: Lean body mass (approximately three years)
C: Change from baseline on the total score of the AMS rating scale (Month 6)
D: Change in the Physical Performance Test (Baseline and 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Randomized Trial of an Automated Smoking Cessation Intervention Via Mobile Phone Text Messages as an Adjunct to Varenicline in Primary Care
Brief Summary: This study is evaluating the feasibility and short term smoking cessation outcomes of an automated smoking cessation intervention delivered via mobile phone text messaging as an adjunct to Varenicline in a primary care setting.


Options:
A: End-of-intervention Varenicline Adherence (4 Weeks)
B: Point prevalence abstinence at 6 months (6 months after beginning treatment)
C: Point Prevalence of 7-day Tobacco Abstinence Biochemically Validated by Exhaled CO < 10ppm at Visit 3 (12 Weeks After Target Quit Day) (12 weeks); Sustained Abstinence at the 12-week Follow up (12 weeks); Number of Days of Varenicline Use (12 weeks); Number of Active Smoking Cessation Activities Used (12 weeks)
D: Continuous Abstinence From Smoking Reported From 4 Weeks Post-randomisation Until Late Pregnancy, Biochemically Validated at Late Pregnancy. (36 weeks gestation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Randomized Trial of an Automated Smoking Cessation Intervention Via Mobile Phone Text Messages as an Adjunct to Varenicline in Primary Care
Brief Summary: This study is evaluating the feasibility and short term smoking cessation outcomes of an automated smoking cessation intervention delivered via mobile phone text messaging as an adjunct to Varenicline in a primary care setting.


Options:
A: Pharmacokinetic parameters: Population mean estimate for apparent plasma clearance (CL/F), central volume of distribution (V2/F) and steady-state volume of distribution (Vss/F).
B: Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers. (3 months); Point Prevalence Abstinence at 3 Months. (3 months)
C: To examine the effects of varenicline treatment used concomitantly with antipsychotic medications, on cognitive dysfunction in people with schizophrenia. (8 weeks)
D: Point Prevalence of 7-day Tobacco Abstinence Biochemically Validated by Exhaled CO < 10ppm at Visit 3 (12 Weeks After Target Quit Day) (12 weeks); Sustained Abstinence at the 12-week Follow up (12 weeks); Number of Days of Varenicline Use (12 weeks); Number of Active Smoking Cessation Activities Used (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Nab-Paclitaxel for Chemotherapy-Naive Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer
Brief Summary: This randomized Phase III, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 \[PD-L1\] antibody) in combination with carboplatin+nab-paclitaxel compared with treatment with carboplatin+nab-paclitaxel in chemotherapy-naive participants with Stage IV non-squamous NSCLC. Participants were randomized in a 2:1 ratio to Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) or Arm B (Nab-Paclitaxel+Carboplatin).


Options:
A: Percentage of Participants Who Died: PP-ITT (Baseline until death due to any cause (up to approximately 2.25 years)); Percentage of Participants Who Died: Tumor Cells (TC)1/2/3 or Tumor-Infiltrating Immune Cells (IC)1/2/3 Subgroup of PP (Baseline until death due to any cause (up to approximately 2.25 years)); Overall Survival (OS): PP-ITT (Baseline until death due to any cause (up to approximately 2.25 years)); OS: TC1/2/3 or IC1/2/3 Subgroup of PP (Baseline until death due to any cause (up to approximately 2.25 years)); OS: SP-ITT (Baseline until death due to any cause (up to approximately 2.87 years)); OS: TC1/2/3 Or IC1/2/3 Subgroup of SP (Baseline until death from any cause (approximately 2.87 years)); OS: TC2/3 or IC2/3 Subgroup of SP (Baseline until death due to any cause (up to approximately 2.87 years)); OS: TC3 or IC3 Subgroup of SP (Baseline until death due to any cause (up to approximately 2.87 years))
B: Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (Up to approximately 19 months); Overall Survival (OS) (Up to approximately 19 months)
C: Progression-Free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the ITT-WT Population (Up to approximately 35 months after first patient enrolled); Overall Survival (OS) in the ITT-WT Population (Up to approximately 35 months after first patient enrolled)
D: Overall survival (OS) (approximately 48 months); Progression-free Survival (PFS) as determined by blinded independent central review (BICR) (approximately 40 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing Cognitive Abilities With Comprehensive Training: A Large, Online, Randomized, Active-Controlled Trial
Brief Summary: The purpose of this study is to measure the efficacy of an online cognitive training program against an active control condition in a large, randomized trial.


Options:
A: Activity Compliance (Compliance with programmed activities will be assessed at the end of participation which is expected to be at 24 weeks)
B: Aggregate Cognitive Performance (Baseline to 10 weeks)
C: Useful Field of View Test (12 months)
D: STROOP-Negative Priming (Change from Baseline Stroop-Negative Priming task at 15 weeks and 30 weeks); ODDBALL (Change from Baseline oddball task at 15 weeks and 30 weeks); N-BACK (Change from Baseline N-back task at 15 weeks and 30 weeks); CORSI BLOCK (Participants with non-action video-game training, change from baseline Corsi block task at 15 weeks and 30 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing Cognitive Abilities With Comprehensive Training: A Large, Online, Randomized, Active-Controlled Trial
Brief Summary: The purpose of this study is to measure the efficacy of an online cognitive training program against an active control condition in a large, randomized trial.


Options:
A: Change in Global Cognition Assessed Using the ADASCog(13 and Plus Modalities). (baseline and at 20 weeks (after interventions finalised))
B: Cognitive impairment assessed with a Neuropsychological Test Battery, and Stroop and Trail Making tests. (2 years)
C: Aggregate Cognitive Performance (Baseline to 10 weeks)
D: Change scores of Montreal Cognitive Assessment (MoCA) (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Stroop test (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Dual-task test (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Timed up and go (TUG) test (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing Cognitive Abilities With Comprehensive Training: A Large, Online, Randomized, Active-Controlled Trial
Brief Summary: The purpose of this study is to measure the efficacy of an online cognitive training program against an active control condition in a large, randomized trial.


Options:
A: Aggregate Cognitive Performance (Baseline to 10 weeks)
B: Total Score on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) (Comparison in the change of RBANS total score from baseline (Week 1) to post-treatment (Week 8) in Intervention Group versus Wait-List Control group)
C: Useful Field of View Test (12 months)
D: Cognitive impairment assessed with a Neuropsychological Test Battery, and Stroop and Trail Making tests. (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing Cognitive Abilities With Comprehensive Training: A Large, Online, Randomized, Active-Controlled Trial
Brief Summary: The purpose of this study is to measure the efficacy of an online cognitive training program against an active control condition in a large, randomized trial.


Options:
A: Change in Global Cognition Assessed Using the ADASCog(13 and Plus Modalities). (baseline and at 20 weeks (after interventions finalised))
B: sleep measures (3-6 months)
C: The study investigates changes in a neuropsychological assessment battery pre-randomization; and upon the completion of training.
D: Aggregate Cognitive Performance (Baseline to 10 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Nutrition Education for Cardiovascular Disease Prevention in Individuals With Spinal Cord Injury
Brief Summary: This is a randomized controlled trial to study a nutrition education intervention in individuals with spinal cord injuries both in the acute rehabilitation setting (n = 100) and the community setting (n = 100). Participants in the treatment group will receive six interactive nutrition lectures based upon a successful program that has been used in older adults titled "Eat Smart, Stay Well". The goals of intervention are to improve whole-grain, fruit and vegetable, and low-fat dairy intake and reduce fat and saturated fat intake. Secondary outcomes will include improvements in waist circumference of body mass index and some biomarkers such as cholesterol and blood sugar.


Options:
A: Nutrition Behavior and Knowledge, measured by Likert scale (Change from baseline at three months, and 12 months)
B: Primary Outcome Measures Described Below (December 2011)
C: Advanced glycation end products levels (Six months)
D: improvement in insulin resistance measured by HOMA index (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The study aims to assess the clinical and economic impact of a pharmaceutical care program initiated in the Emergency Department versus conventional follow-up of patients with decompensated heart failure/COPD.


Options:
A: Incident adverse drug reactions (ADRs). at least one likely or certain, non-trivial hospital acquired ADR. (Day 14 of hospital stay or discharge, which ever comes first)
B: Drug Related Problems (DRP) (Participants will be followed for the duration of hospital stay, an expected average of 10 days); Mortality (6-month after inclusion); Average length of the hospital stay (Participants will be followed for the duration of hospital stay, an expected average of 10 days); Readmissions (6-month after inclusion); Average cost of hospital stay (Participants will be followed for the duration of hospital stay, an expected average of 10 days)
C: ADEs (Measured 30 and 90 days after hospital discharge); Medication appropriateness (Measured 30 and 90 days after hospital discharge by the Hanlon et al. Medication Appropriateness Index); Complications related to medications, including the number of hospital readmissions, unscheduled visits to emergency departments or urgent care facilities, and physician visits related to a medication problem or ADE (Measured 30 and 90 days after hospital discharge); Cost-effectiveness of the minimal or enhanced treatment compared to usual care (Measured 30 and 90 days after hospital discharge)
D: The primary outcome will be unintentional medication discrepancies in admission orders and discharge orders with potential for patient harm (6 months prior to implementation of intervention to 21 months during intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The study aims to assess the clinical and economic impact of a pharmaceutical care program initiated in the Emergency Department versus conventional follow-up of patients with decompensated heart failure/COPD.


Options:
A: Maximum Plasma Concentration at Steady-state (Cmax,ss) (Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 minutes (min) before study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 hour (h), 2 h, 4 h and 6 h post dosing.); Area Under the Curve 0 to 6 Hours at Steady-state (AUC0-6h,ss) (Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 minutes (min) before study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 hour (h), 2 h, 4 h and 6 h post dosing.)
B: Drug Related Problems (DRP) (Participants will be followed for the duration of hospital stay, an expected average of 10 days); Mortality (6-month after inclusion); Average length of the hospital stay (Participants will be followed for the duration of hospital stay, an expected average of 10 days); Readmissions (6-month after inclusion); Average cost of hospital stay (Participants will be followed for the duration of hospital stay, an expected average of 10 days)
C: Forced expiratory volume 1 second (FEV1) (16 weeks)
D: Insomnia (Up to 18 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The study aims to assess the clinical and economic impact of a pharmaceutical care program initiated in the Emergency Department versus conventional follow-up of patients with decompensated heart failure/COPD.


Options:
A: Drug Related Problems (DRP) (Participants will be followed for the duration of hospital stay, an expected average of 10 days); Mortality (6-month after inclusion); Average length of the hospital stay (Participants will be followed for the duration of hospital stay, an expected average of 10 days); Readmissions (6-month after inclusion); Average cost of hospital stay (Participants will be followed for the duration of hospital stay, an expected average of 10 days)
B: Improvement of drug prescribing (Participants will be followed for the duration of hospital stay, an expected average of 12 days)
C: All-cause Death, Heart Failure-related Re-hospitalizations, and a Composite Outcome of Both Death and Heart Failure-related Re-hospitalizations (2 year)
D: Emergency medical visits (12 months after hospital discharge)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Coping With Loss: A Bereavement Initiative for Adolescent Girls in the Free State, South Africa
Brief Summary: Coping with Loss is a randomized controlled trial to assess the effectiveness of a bereavement intervention targeting female adolescents who have experienced the death of someone important in their lives. Adolescents aged 12 and older in the Free State province of South Africa will be invited to participate in an 8-session school-based peer support group focused on coping with loss. Interventions will be implemented by Social Workers from Child Welfare Bloemfontein and Childline Free State (CWBFN \& CLFS) that have provided support services for orphans and vulnerable children (OVC) in the Free State Province since 2013. The study population will be identified through the CWBFN \& CLFS intake process and consist of bereaved female adolescents from up to 11 participating schools. Eligible adolescents will be randomly assigned to receive the intervention in 2015 or wait-listed for enrollment following the study period. Survey data will be collected from adolescents and caregivers before and two months following the completion of the interventions. Data will be analyzed to assess for pre- and post-test differences between the intervention and wait-listed group on key psychosocial outcomes, including measures of grief, resilience, mental health, social support, academic competence and adolescent-caregiver interactions.


Options:
A: Systolic blood Pressure (Baseline and 12 months); Glycated haemoglobin (HbA1c) (Baseline and 12 months)
B: Physical Violence From School Staff (2-year follow-up)
C: Change in COVID-19 knowledge (Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey); Change in COVID-19 protective behaviors (Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey); Change in depressive symptoms (Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey); Change in anxiety symptoms (Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey)
D: Change in Grief Intensity (Baseline, 2 months post-intervention); Change in Mental Health (Baseline, 2 months post-intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Transplant Social Worker Support for Live Kidney Donation in African Americans
Brief Summary: Talking About Live Kidney Donation Support (TALKS) will study the effectiveness of education, behavior, and financial support interventions to improve consideration of live kidney transplantation/live kidney donation among African Americans on the deceased kidney waiting list. We hypothesize that interventions to help potential kidney transplant recipients and their potential donors overcome barriers to live donor kidney transplant (including family discussions, financial, or logistical barriers) could improve potential recipients' receipt of live kidney transplants. The main outcomes of TALKS will include whether potential recipients (1) have potential live donors call into the transplant center on their behalf; (2) have potential donors evaluated for transplant; or (3) receive a live donor kidney transplant.


Options:
A: psychological distress (6 weeks post-donation); somatic/physical health perceptions (6 weeks post-donation); interpersonal relationship quality and distress (6 weeks post-donation); quality of life (6 weeks post-donation); psychological distress (3 months post-donation); somatic/physical health perceptions (3 months post-donation); interpersonal relationship quality and distress (3 months post-donation); quality of life (3 months post-donation)
B: Number of Participants With Live Kidney Donor Activation Events (24 months post randomization)
C: Organ Donation Registration (6 months)
D: Pursuit of Living Related Transplantation (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Transplant Social Worker Support for Live Kidney Donation in African Americans
Brief Summary: Talking About Live Kidney Donation Support (TALKS) will study the effectiveness of education, behavior, and financial support interventions to improve consideration of live kidney transplantation/live kidney donation among African Americans on the deceased kidney waiting list. We hypothesize that interventions to help potential kidney transplant recipients and their potential donors overcome barriers to live donor kidney transplant (including family discussions, financial, or logistical barriers) could improve potential recipients' receipt of live kidney transplants. The main outcomes of TALKS will include whether potential recipients (1) have potential live donors call into the transplant center on their behalf; (2) have potential donors evaluated for transplant; or (3) receive a live donor kidney transplant.


Options:
A: Taking Adherence (12 months); Timing Adherence (12 months)
B: Change in blood pressure measurement at baseline and at one year follow-up (Baseline and one year follow-up)
C: The primary outcome for this study is the proportion of enrolled patients with live donor kidney transplants. (one year)
D: Number of Participants With Live Kidney Donor Activation Events (24 months post randomization)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: International Postmarketing Surveillance Study of Pl-VEGF165 Safety and Efficacy in 210 Patients With Peripheral Arterial Disease
Brief Summary: Aim of the study is to gain more knowledge about efficacy and safety of Neovasculgen® in daily clinical practice and obtain information about the quality of life in patients treated with Neovasculgen®.


Options:
A: Primary efficacy parameter: ulcer healing.; Ulcers will be evaluated at each visit primarily by collecting quantitative and qualitative information.
B: Tissue perfusion as measured by TcPO2 (6 months)
C: Peak Walking Time (at 6 months)
D: Change in the measurement of pain-free walking distance (PWD) on treadmill (3 months and 6 months after the first injection of Neovasculgen®.)

Answer: D