TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Temozolomid (One Week on/One Week Off) Versus Strahlentherapie in Der Primärtherapie Anaplastischer Astrozytome Und Glioblastome Bei älteren Patienten: Eine Randomisierte Phase III-Studie (Methvsalem)
Brief Summary: The study aims to optimize the treatment of elderly subjects (\> 65) with anaplastic astrocytoma and glioblastoma. Current treatment policies tend to be no more than palliative. There is no consensus as to how radical the surgery should be. Involved-field radiotherapy is the treatment most likely to be accepted apart from supportive and palliative measures. The role of chemotherapy is barely defined. Study data available to date does not suggest that this patient population would benefit from combined radiochemotherapy. The aim of the study is to verify the hypothesis that first-line chemotherapy with one week on/one week off temozolomide is not inferior to extended-field radiotherapy in the first-line treatment of anaplastic astrocytoma and glioblastoma in the elderly (\> 65 age group). The primary endpoint is median survival, as life expectancy is limited to several months. Secondary endpoints are response rates in both arms (CR, PR, MacDonald et al. 1990), median progression-free survival, 1-year and 2-year survival rates, definition of MGMT as molecular genetic prognostic or predictive markers, and quality of life. Theoretically, it should be possible to preserve quality of life in the first-line chemotherapy arm of the study.


Options:
A: To determine the rate of non-progressive disease at 6 months after inclusion in each arms (after half of each arms has been completed at 6 months of treatment)
B: Progression Free Survival (PFS) (Baseline at 6 weeks and then every 6 weeks to discontinuation)
C: Survival (assessed every 6 weeks for 42 weeks, then every 4 months for one year, followed by every 6 months for years 2 through 5)
D: Overall survival (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Temozolomid (One Week on/One Week Off) Versus Strahlentherapie in Der Primärtherapie Anaplastischer Astrozytome Und Glioblastome Bei älteren Patienten: Eine Randomisierte Phase III-Studie (Methvsalem)
Brief Summary: The study aims to optimize the treatment of elderly subjects (\> 65) with anaplastic astrocytoma and glioblastoma. Current treatment policies tend to be no more than palliative. There is no consensus as to how radical the surgery should be. Involved-field radiotherapy is the treatment most likely to be accepted apart from supportive and palliative measures. The role of chemotherapy is barely defined. Study data available to date does not suggest that this patient population would benefit from combined radiochemotherapy. The aim of the study is to verify the hypothesis that first-line chemotherapy with one week on/one week off temozolomide is not inferior to extended-field radiotherapy in the first-line treatment of anaplastic astrocytoma and glioblastoma in the elderly (\> 65 age group). The primary endpoint is median survival, as life expectancy is limited to several months. Secondary endpoints are response rates in both arms (CR, PR, MacDonald et al. 1990), median progression-free survival, 1-year and 2-year survival rates, definition of MGMT as molecular genetic prognostic or predictive markers, and quality of life. Theoretically, it should be possible to preserve quality of life in the first-line chemotherapy arm of the study.


Options:
A: Overall Survival (7 years)
B: Overall survival (12 months)
C: N/A
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Patients' Knowledge and Understanding of Cancer Clinical Trials - a Randomised Study of Audio Recorded Information
Brief Summary: The purpose of this study is to test if cancer patients who are informed about, and offered participation in a cancer clinical trial, are more knowledgeable about cancer clinical trials if they have access to an audio recording of their information visit.


Options:
A: Patients' knowledge about clinical trials measured by the questionnaire Quality of Informed Consent (The questionnaire is sent to patients within a week after consenting to the trial.)
B: N/A
C: Safety (local and systemic reactogenicity, lab tests, AEs)
D: safety (local and systemic reactogenicity, lab tests, AEs)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Translation of Comparative Effectiveness of Depression Medications Into Practice
Brief Summary: The purpose of this study is to determine whether the Depression Medication Choice decision aid is effective in involving patients with depression in making deliberate choices when considering medication treatment.


Options:
A: Primary Outcomes(composite): i) decision aid development, and ii) decision aid evaluation. (Phase 1-2 (1- year))
B: 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)
C: Differences in patient-reported satisfaction between treatment groups (6 weeks); Differences in decision regret between treatment groups (6 weeks)
D: Quality of Decision Making (Immediately following each patient's index visit and before they leave the clinic on that day, typically within 10 minutes of completing the clinical encounter.); Knowledge Transfer (Immediately following each patient's index visit and before they leave the clinic on that day, typically within 10 minutes of completing the clinical encounter.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Translation of Comparative Effectiveness of Depression Medications Into Practice
Brief Summary: The purpose of this study is to determine whether the Depression Medication Choice decision aid is effective in involving patients with depression in making deliberate choices when considering medication treatment.


Options:
A: Quality of Decision Making (Immediately following each patient's index visit and before they leave the clinic on that day, typically within 10 minutes of completing the clinical encounter.); Knowledge Transfer (Immediately following each patient's index visit and before they leave the clinic on that day, typically within 10 minutes of completing the clinical encounter.)
B: Shared Decision Making (OPTION) Independent Blind Coder Assessment Scores (Follow-up assessment (2 months)); Shared Decision Making Questionnaire (SDM-Q-9 Patient Version) (End-of-intervention Assessment (5 months)); Provider Shared Decision Making in Behavioral Health (SDM -BH) Provider Version (Follow-up Assessment (2 months)); Shared Decision Making Questionnaire (SDM-Q-9 Provider Version) (Follow-up Assessment (2 months)); Perceptions of Care Survey - Global Evaluation of Care Scale (PoC) (End-of-intervention Assessment (5 months)); Patient Shared Decision Making in Behavioral Health (SDM -BH)- Patient Version (End-of-intervention Assessment (5 months))
C: Proportion of women prescribed potentially teratogenic medications with documented use of contraception (1 year)
D: PTSD Symptoms (Post-treatment, ten weeks); Depression Symptoms (Measured at Post-Treatment, at 10 weeks); State Anxiety (Measured at Post-Treatment, at 10 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Translation of Comparative Effectiveness of Depression Medications Into Practice
Brief Summary: The purpose of this study is to determine whether the Depression Medication Choice decision aid is effective in involving patients with depression in making deliberate choices when considering medication treatment.


Options:
A: Patient knowledge (Immediately after patient visit)
B: Change in severity of depression symptoms: Centre for Epidemiologic Studies Depression Scale (CES-D) (Baseline, 3 months, 6 months)
C: Quality of Decision Making (Immediately following each patient's index visit and before they leave the clinic on that day, typically within 10 minutes of completing the clinical encounter.); Knowledge Transfer (Immediately following each patient's index visit and before they leave the clinic on that day, typically within 10 minutes of completing the clinical encounter.)
D: Efficacy of the PCI Choice Decision aid vs. Usual Care assessed by Patient and Provider Surveys, and encounter Video/Audio Recordings (Baseline to Three Months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Parent-Led Interventions in Reducing Infant Hypersensitivity to Pain: A Longitudinal Randomized Controlled Trial
Brief Summary: The aim of this study is to find out the effects of routinely using different types of pain-relieving strategies during routine immunization injections performed in infants.


Options:
A: Post-operative pain score (Daily average for 7 days); Change in post-operative pain score with intervention (Daily for 7 days); Heart rate (Daily average for 7 days); Respiratory rate (Daily average for 7 days); Oxygen saturation (Daily average for 7 days); Change in heart rate with intervention (Daily for 7 days); Change in respiratory rate with intervention (Daily for 7 days); Change in oxygen saturation with intervention (Daily for 7 days)
B: Hypersensitivity to pain (At 15 month vaccination (Visit 5))
C: technical quality of the LP, classified as success or failure. (immediate)
D: To measure analgesic effectiveness of the 5 S's (swaddling, side/stomach position, shushing, swinging, and sucking) alone and combined with sucrose, during routine immunizations at 2 and 4 month well child visits. (every 15 sec)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Noninvasive Brain Stimulation for Stroke Improvement
Brief Summary: Noninvasive brain stimulations will be used in acute and chronic stroke patients to improve a variety of functions.


Options:
A: Change from Baseline in the motor impairment as assessed by the Fugl-Meyer Motor Assessment Scale (upper extremity subsection) (6 weeks)
B: Quantify of variability of the center-of-mass movement (30 minutes)
C: Change from baseline Fugl Meyer Assessment(FMA)upper extremities subscale after intervention (Assessed at the baseline section (within 3 days ahead to the 1st intervention section), and then again immediately following the 8 weeks intervention (within 3 days after the latest intervention section)); Change from baseline Active joint activity after intervention (Assessed at the baseline section (within 3 days ahead to the 1st intervention section), and then again immediately following the 8 weeks intervention (within 3 days after the latest intervention section)); Change from baseline Muscle tone after intervention (Assessed at the baseline section (within 3 days ahead to the 1st intervention section), and then again immediately following the 8 weeks intervention (within 3 days after the latest intervention section))
D: change in function before/after tDCS (Before intervention, immediately after intervention, 10-20-30-40-50-60 min after intervention; long-term after intervention : 1-2-3-4 weeks, 2-3-4-5-6-7-8-9-10-11-12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Noninvasive Brain Stimulation for Stroke Improvement
Brief Summary: Noninvasive brain stimulations will be used in acute and chronic stroke patients to improve a variety of functions.


Options:
A: Jebsen Taylor Hand Function Test (2 weeks); Cortical Excitability (1 hour); Cortical Oscillations - EEG (15 minutes)
B: Change in Upper Limb function (Baseline and posttest (an average of 2 weeks from baseline))
C: Change of Fugl-Meyer assessment (FMA) score (Change from baseline in FMA score on the 3rd intervention day; change from baseline in FMA score at 1 week post intervention)
D: change in function before/after tDCS (Before intervention, immediately after intervention, 10-20-30-40-50-60 min after intervention; long-term after intervention : 1-2-3-4 weeks, 2-3-4-5-6-7-8-9-10-11-12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Noninvasive Brain Stimulation for Stroke Improvement
Brief Summary: Noninvasive brain stimulations will be used in acute and chronic stroke patients to improve a variety of functions.


Options:
A: Change in Fugl-Meyer assessment of paretic upper limb motor function (baseline, after sessions, 30 and 90 days)
B: Change from baseline in Upper Extremity Fugl Meyer Assessment (Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks)
C: JTT (crossover design, four different sessions with four different interventions)
D: change in function before/after tDCS (Before intervention, immediately after intervention, 10-20-30-40-50-60 min after intervention; long-term after intervention : 1-2-3-4 weeks, 2-3-4-5-6-7-8-9-10-11-12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Bioefficacy of Vitamin D2 and Vitamin D3: Randomized Trial With Human Volunteers
Brief Summary: The aim of this study is to investigate the bioavailability of vitamin D2 and D3 as measured by the increase of the specific hydroxy forms in serum (25(OH)D2 and 25(OH)D3, respectively, and by total 25(OH)D.


Options:
A: Breast Cancer Recurrence (Lifetime)
B: Number of Participants Who Develop Hypercalcemia (6 months)
C: Colorectal Adenomas (1 to 10 years)
D: change of 25-hydroxvitamin D (after 4 and 8 weeks of supplementation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Stage 2 Cognitive-behavioral Trial: Reduce Alcohol First in Kenya Intervention
Brief Summary: This study will determine whether a group cognitive-behavioral therapy intervention that demonstrates preliminary evidence of reducing alcohol use among HIV-infected outpatients in western Kenya is effective when compared against a group health education intervention in a large sample over a longer period of time. It will be delivered by paraprofessionals, individuals with limited formal education and little or no relevant professional experience. This approach is consistent with successful cost-effective models of service delivery in resource-limited settings in which paraprofessionals (e.g., clinical officers, traditional birth attendants and peer counselors) are trained.


Options:
A: Change on Beck Depression Inventory-II (Screening; baseline, 6-8 weeks after baseline and 4 months after baseline)
B: quantity and frequency of alcohol use (30 days post-treatment)
C: Timeline Followback alcohol use (percent drinking days) (longitudinal alcohol use from baseline (past 30 days) to 9 month post-intervention follow up)
D: Depression (6 Months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Girls on the Move Intervention
Brief Summary: The purpose of this school-based trial is to test the efficacy of an intervention to increase moderate to vigorous physical activity (MVPA) among middle school girls. The 17-week "Girls on the Move" (GOTM) intervention has 3 components. Two individual-level components occurring during school hours include: (1) two face-to-face motivational, individually tailored counseling sessions with a school nurse, and (2) an interactive Internet-based session during which each girl receives motivational, individually tailored feedback messages (at 9 weeks). A group-level component, 90-minute Physical Activity (PA) Club provides an important venue after school that includes activities to assist girls in establishing a behavioral pattern of MVPA. The control condition will complete data collection activities and receive their usual school offerings.

The investigators hypothesize that immediately post-intervention, minutes of MVPA will be greater by 16 min./wk. in the intervention than control group; At 9 months post-intervention follow-up, minutes of MVPA will be greater in the intervention than control group; and immediately post-intervention, cardiovascular (CV) fitness will be higher and body mass index (BMI) and percent body fat will be lower in the intervention than control group.


Options:
A: Intake of unhealthy foods, unhealthy drinks, healthy foods assessed by a photo-based method (volume) (6 months post baseline); Intake of unhealthy foods, unhealthy drinks, healthy foods assessed by a photo-based method (volume) (18 months post baseline)
B: Change in body mass index (BMI). (Baseline through Follow-up: Grades 5-6-7-8)
C: change in physical activity (change from baseline to follow-ups at 6, 12, 18 months)
D: Minutes of Moderate to Vigorous Physical Activity (MVPA) Post-intervention (Minutes of moderate to vigorous physical activity per hour at post-intervention (after 17-week intervention))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Girls on the Move Intervention
Brief Summary: The purpose of this school-based trial is to test the efficacy of an intervention to increase moderate to vigorous physical activity (MVPA) among middle school girls. The 17-week "Girls on the Move" (GOTM) intervention has 3 components. Two individual-level components occurring during school hours include: (1) two face-to-face motivational, individually tailored counseling sessions with a school nurse, and (2) an interactive Internet-based session during which each girl receives motivational, individually tailored feedback messages (at 9 weeks). A group-level component, 90-minute Physical Activity (PA) Club provides an important venue after school that includes activities to assist girls in establishing a behavioral pattern of MVPA. The control condition will complete data collection activities and receive their usual school offerings.

The investigators hypothesize that immediately post-intervention, minutes of MVPA will be greater by 16 min./wk. in the intervention than control group; At 9 months post-intervention follow-up, minutes of MVPA will be greater in the intervention than control group; and immediately post-intervention, cardiovascular (CV) fitness will be higher and body mass index (BMI) and percent body fat will be lower in the intervention than control group.


Options:
A: Minutes of Moderate to Vigorous Physical Activity (MVPA) Post-intervention (Minutes of moderate to vigorous physical activity per hour at post-intervention (after 17-week intervention))
B: Overweight and obesity according to IOTF references (0-1-2 years)
C: BMI-for-age z-score and percentiles (measured weight and height, self-reported gender and date of birth)and Body composition (Dual Energy X-ray Absorptiometry, and Bioelectrical Impedance Analysis) (2 years)
D: Change in Body Mass Index From T1 to T3 (T1 (Baseline) to T3 (9 months-post baseline)); Change in Total Body Weight From T1 to T3 (T1 (baseline) to T3 (9-month post baseline)); Change in Pounds of Body Fat From T1 to T3 (T1 ( Baseline) to T3 (9-months post baseline))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Definitive Phase III Study of the Effects of Ferric Citrate on Serum Phosphate in Subjects With End Stage Renal Disease
Brief Summary: The purpose of the study is to determine the effect and optimum dose and evaluate the safety of ferric citrate, administered three times daily (TID) immediately after meals for a total daily dose of 4 or 6 grams for 56 days, on serum phosphate (PO4) levels in subjects with end stage renal disease (ESRD).


Options:
A: Change in Serum Inorganic Phosphorus at the End of Treatment From Baseline (baseline and end of the chewing treatment during three week treatment period)
B: Change in serum phosphorus at Day 56 as compared to baseline (Day 56)
C: Composite end-point of Ca, P, Ca*P within K/DOQI recommendation (12 months)
D: Evaluate the change from baseline in 72-hour serum phosphate levels of 4 different doses of SBR759 versus placebo over 4 weeks of treatment (6 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Simplified Cardiovascular Management Study: A Cluster-Randomized Trial to Evaluate the Effects of a Simplified Cardiovascular Management Program in Tibet, China and Haryana, India
Brief Summary: The goal of this study is to develop, pilot test, and evaluate a highly simplified but guideline-based program for cardiovascular management for application in resource-scarce settings. The study aims to assess the effects of implementing a simple low-cost cardiovascular management program for high-risk individuals, delivered by primary care providers (PCPs) or community health workers (CHWs), on the proportion of patients appropriately treated with diuretics as well as a number of secondary outcomes in resource-scarce Tibet, China and Haryana India.


Options:
A: Composite Outcome Measure: Mean Percentage of CDPS Actions at Baseline That Are Subsequently Met at Follow-up (Six months)
B: Composite outcome of multiple cardiovascular risk factors (2 year)
C: Physical activity (4 years); Modelled cardiovascular risk (4 years); Health related quality of life (4 years); Functional capacity (4 years)
D: Net Difference in Proportion Treated with Low-dose Diuretics (baseline and at one year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Simplified Cardiovascular Management Study: A Cluster-Randomized Trial to Evaluate the Effects of a Simplified Cardiovascular Management Program in Tibet, China and Haryana, India
Brief Summary: The goal of this study is to develop, pilot test, and evaluate a highly simplified but guideline-based program for cardiovascular management for application in resource-scarce settings. The study aims to assess the effects of implementing a simple low-cost cardiovascular management program for high-risk individuals, delivered by primary care providers (PCPs) or community health workers (CHWs), on the proportion of patients appropriately treated with diuretics as well as a number of secondary outcomes in resource-scarce Tibet, China and Haryana India.


Options:
A: The comparison of change in vascular monitoring process total score (proportion of process targets met in group) between intervention and control groups. (6 months to 1 year)
B: Change in serum LDL-cholesterol level (at 6 months post disclosure of CAD risk)
C: percentage of participants with increase of the adequacy of lipid-lowering prescription (up to 24 months)
D: Net Difference in Proportion Treated with Low-dose Diuretics (baseline and at one year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Simplified Cardiovascular Management Study: A Cluster-Randomized Trial to Evaluate the Effects of a Simplified Cardiovascular Management Program in Tibet, China and Haryana, India
Brief Summary: The goal of this study is to develop, pilot test, and evaluate a highly simplified but guideline-based program for cardiovascular management for application in resource-scarce settings. The study aims to assess the effects of implementing a simple low-cost cardiovascular management program for high-risk individuals, delivered by primary care providers (PCPs) or community health workers (CHWs), on the proportion of patients appropriately treated with diuretics as well as a number of secondary outcomes in resource-scarce Tibet, China and Haryana India.


Options:
A: motivation (2 years)
B: extent to which a computer-based clinical decision-support system (accompanying computerized provider order-entry) can improve the quality of medication ordering and monitoring (two years)
C: %patients at ATP III goals (one year after intervention)
D: Net Difference in Proportion Treated with Low-dose Diuretics (baseline and at one year)

Answer: D