TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Go NAP SACC: A Pilot Study Evaluating the Nutrition Tool of the Web-based Tool Based on the NAP SACC Program
Brief Summary: The purpose of this project is to evaluate the effectiveness of Go NAP SACC (Get online with Nutrition and Physical Activity Self-Assessment for Child Care), a suite of web-based tools designed to help child care programs improve their nutrition environment (specifically classrooms serving 3-5 year olds) over the course of 4 months.


Options:
A: Caloric intake in the Eating in the Absence of Hunger (EAH) paradigm (week 4)
B: Change in Observed Child Dietary Intake (8 Months); Change in Measured Child Physical Activity in Child Care (8 months); Change in Observed Child Dietary Intake (12 Months); Change in Measured Child Physical Activity in Child Care (12 Months)
C: Change in Body Mass Index (Baseline, 8 months, 21 months)
D: Change in EPAO-SR Scores from Baseline to Post-intervention (Measures collected at baseline (2-4 weeks prior to the intervention) and post-intervention (1-3 weeks following the intervention))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Go NAP SACC: A Pilot Study Evaluating the Nutrition Tool of the Web-based Tool Based on the NAP SACC Program
Brief Summary: The purpose of this project is to evaluate the effectiveness of Go NAP SACC (Get online with Nutrition and Physical Activity Self-Assessment for Child Care), a suite of web-based tools designed to help child care programs improve their nutrition environment (specifically classrooms serving 3-5 year olds) over the course of 4 months.


Options:
A: Change in EPAO-SR Scores from Baseline to Post-intervention (Measures collected at baseline (2-4 weeks prior to the intervention) and post-intervention (1-3 weeks following the intervention))
B: Change in BMIz (Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).)
C: Child percent body fat after the 8-month intervention period, controlling for baseline percent body fat. Percent body fat will be calculated using Dezenberg's equation which takes into account child height, weight, gender, race, and tricep skinfolds. (baseline, 8 months and 14 months)
D: Change in Percentage of Children Meeting Physical Activity Policy (Spring of Year 1, Year 2, and Year 3)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Go NAP SACC: A Pilot Study Evaluating the Nutrition Tool of the Web-based Tool Based on the NAP SACC Program
Brief Summary: The purpose of this project is to evaluate the effectiveness of Go NAP SACC (Get online with Nutrition and Physical Activity Self-Assessment for Child Care), a suite of web-based tools designed to help child care programs improve their nutrition environment (specifically classrooms serving 3-5 year olds) over the course of 4 months.


Options:
A: 1-year, and 3-year changes from baseline in questionaires scores for knowledge, attitudes, and habits of children, parents and teachers in regards to a healthy lifestyle. (3 years)
B: Change in EPAO-SR Scores from Baseline to Post-intervention (Measures collected at baseline (2-4 weeks prior to the intervention) and post-intervention (1-3 weeks following the intervention))
C: Change in The Environment and Policy Assessment and Observation tool (EPAO) score (3 years)
D: Change in Child BMI-z score (Collected at the beginning and end of each academic year (i.e., fall, spring) for 3 years (BL, Y1, Y2) rather than 4 years as planned); Modified change in BMI z-score (Collected at the beginning and end of each academic year (i.e., fall, spring) for 3 years (BL, Y1, Y2))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Go NAP SACC: A Pilot Study Evaluating the Nutrition Tool of the Web-based Tool Based on the NAP SACC Program
Brief Summary: The purpose of this project is to evaluate the effectiveness of Go NAP SACC (Get online with Nutrition and Physical Activity Self-Assessment for Child Care), a suite of web-based tools designed to help child care programs improve their nutrition environment (specifically classrooms serving 3-5 year olds) over the course of 4 months.


Options:
A: Change in EPAO-SR Scores from Baseline to Post-intervention (Measures collected at baseline (2-4 weeks prior to the intervention) and post-intervention (1-3 weeks following the intervention))
B: Intake of vegetables and fruit (One month)
C: Change in vegetable intake (Measured at child age of 4-6 months (prior to intervention), 18 months (directly after intervention) and at child age of 24 and 36 months (6 and 18 months follow-up)); Change in vegetable liking (Measured at child age of 4-6 months (prior to intervention), 18 months (directly after intervention) and at child age of 24 and 36 months (6 and 18 months follow-up)); Child self-regulation of energy intake (Measured at child age of 18 months); Change in child self-regulation of energy intake (Measured at child age of 4-6 months (prior to intervention), 18 months (directly after intervention) and at child age of 24 and 36 months (6 and 18 months follow-up))
D: Growth trajectories (using BMI, waist circumference), body composition (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Go NAP SACC: A Pilot Study Evaluating the Nutrition Tool of the Web-based Tool Based on the NAP SACC Program
Brief Summary: The purpose of this project is to evaluate the effectiveness of Go NAP SACC (Get online with Nutrition and Physical Activity Self-Assessment for Child Care), a suite of web-based tools designed to help child care programs improve their nutrition environment (specifically classrooms serving 3-5 year olds) over the course of 4 months.


Options:
A: 1-year, and 3-year changes from baseline in questionaires scores for knowledge, attitudes, and habits of children, parents and teachers in regards to a healthy lifestyle. (3 years)
B: Change in EPAO-SR Scores from Baseline to Post-intervention (Measures collected at baseline (2-4 weeks prior to the intervention) and post-intervention (1-3 weeks following the intervention))
C: Change in BMIz (Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).)
D: Primary Outcome Measure: BMI (6 months, 1 year, 2 year, 5 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Go NAP SACC: A Pilot Study Evaluating the Nutrition Tool of the Web-based Tool Based on the NAP SACC Program
Brief Summary: The purpose of this project is to evaluate the effectiveness of Go NAP SACC (Get online with Nutrition and Physical Activity Self-Assessment for Child Care), a suite of web-based tools designed to help child care programs improve their nutrition environment (specifically classrooms serving 3-5 year olds) over the course of 4 months.


Options:
A: Change in Nutrition and Physical Activity Policies (Baseline, Year 1, Year 2)
B: Change in EPAO-SR Scores from Baseline to Post-intervention (Measures collected at baseline (2-4 weeks prior to the intervention) and post-intervention (1-3 weeks following the intervention))
C: Change in Minutes of Moderate-to- Vigorous Physical Activity (MVPA) (Measured at baseline and 10 months for each wave of data collection)
D: Change in The Environment and Policy Assessment and Observation tool (EPAO) score (3 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Culturally-tailored Narrative Intervention to Target Disparities in Obesity
Brief Summary: The purpose of this study is to determine the efficacy of a community-based behavioral intervention (H2GO!) on decreasing sugar-sweetened beverage consumption and promoting water consumption among school-aged youth and parents/caregivers. We hypothesize that participants in the intervention site will demonstrate reduced sugar-sweetened beverage intake intake and increased water intake compared to participants in the comparison site at 2 and 6 months follow-up.


Options:
A: Change from baseline in Total Kilocalorie intake at 16 weeks (16 weeks); Change from baseline in reported levels of household food security at 16 weeks (16 weeks); Change from baseline in Healthy Eating Index (HEI) Score at 16 weeks (16 weeks); Change from baseline in daily servings of fruits and vegetable (added together) at 16 weeks (16 weeks); Change from baseline in daily total, in grams, of added sugars at 16 weeks (16 weeks)
B: N/A
C: Employee purchases of healthy (green-labeled) items (6 months)
D: Sugar-sweetened beverage consumption (Change from baseline to 6 months); Water consumption (Change from baseline to 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Innovative Incentive Strategies for Sustainable HIV Testing and Antiretroviral Treatment
Brief Summary: The success of combination HIV prevention efforts, including HIV treatment as prevention, hinges on universal, routine HIV testing with effective treatment after HIV diagnosis. The proposed study will evaluate the comparative effectiveness and sustainability of innovative incentive strategies, informed directly by behavioral economics and decision psychology, to promote HIV testing among men and HIV treatment among HIV-infected adults in rural Uganda.


Options:
A: Number of Participants Who Present Children for HIV Testing (2 months); Number of Days Participants Take to Bring Children for HIV Testing (2 months)
B: 7-day point prevalence abstinence at 3 months (3 months post baseline); 7-day point prevalence abstinence at 6 months (6 months post baseline); 7-day point prevalence abstinence at 12 months (12 months post baseline)
C: Proportion of participants who receive an HIV test at a community health campaign between intervention groups (6-8 weeks after enrollment; annually); Proportion of participants with HIV RNA <400 copies/mL between intervention groups (6 months after enrollment); Proportion of participants randomized to loss aversion trial who make a deposit (At enrollment); Proportion of participants who complete all HIV retest visits at study venue (6 months)
D: Number of Participants With HIV Viral Load < 40 Copies/ML at 1 Year (1 year); Change From Baseline in CD4 Count at 1 Year (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Feasibility Study on the Impact of Economic Incentives for Weight Loss to Improve the Management of Type 2 Diabetes Mellitus: REDEEM Feasibility Study
Brief Summary: This feasibility study aims to compare the implementation process of three different interventions that use economic incentives to promote lifestyle behavioral changes in patients with type 2 diabetes mellitus, and to identify barriers and facilitators linked to the process of implementing each of the interventions. The interventions are based on economic incentives directed to the patient (individual incentives) or a team comprised by the patient and a partner (mixed incentives).

Design: Three-month randomized control feasibility study to test the feasibility of implementing three types of intervention with economic incentives in patients with diabetes mellitus.

Setting: Diabetes outpatient clinics from a public hospital in Peru.


Options:
A: HbA1c (1 year)
B: Change from baseline in HbAlc level; percentage of subjects reaching or maintaining the risk target (represented by a combination of LBGI<=2.5 together with HBGI<=5). (Visit 5 (52 weeks after Visit 1 +/- 2 weeks).)
C: HbA1c (Last measurement within 12 months before - and 15 months after nurse participation in the course)
D: Change in Glycated Hemoglobin (Baseline and 3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study of a Symptom Monitoring Intervention for Hospitalized Patients With Cancer
Brief Summary: The purpose of this research study is to address the challenge of symptom management for hospitalized patients with cancer.


Options:
A: proportion of patients in both groups with diseased quality of life (<50 points in at least one dimension) (1 year after the date of primary surgery for colorectal cancer)
B: UWQOL v4 QoL (Post-Treatment 1 Year Review Clinic)
C: Child Distress - unrelieved symptoms (20 weeks); Trends of PedsQL Total Scores (20 weeks); Trends of MSAS total scores (20 weeks); Trends of MSAS physical scores (20 weeks); Trends of MSAS psychological scores (20 weeks); Trends of PedsQL Physical Subscale Scores (20 weeks); Trends of PedsQL Emotional Subscale Scores (20 weeks)
D: Rates of participant completion of >2 symptom reports (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3, Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Maintenance Treatment of Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) (INNO2VATE-CONVERSION)
Brief Summary: A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in participants with dialysis-dependent chronic kidney disease (DD-CKD)


Options:
A: Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36) (Baseline; Weeks 24 to 36); Median Time to First Major Adverse Cardiovascular Event (MACE) (Up to 170 weeks)
B: Mean Hb (Hemoglobin) level (From week 30 to 36); Change in hemoglobin level from baseline to the average during the evaluation period (Baseline and week 30 to 36)
C: Modeled Hgb Change From Baseline Over 4 Weeks of Treatment (Baseline (average of Week -2, -1 and Day 1) and Week 4)
D: The mean Hb level during the evaluation period (From week 33 to 36); The change in mean Hb level during the evaluation period from baseline (Baseline and week 33 to 36)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Randomized, 12-week Treatment, Doubleblind Study to Assess the Efficacy and Safety of QMF149 (150/80 Microgram) Compared With MF Twisthaler® (200 Microgram) in Adult and Adolescent Patients With Asthma
Brief Summary: The purpose of the trial was to evaluate efficacy and safety of QMF149 150/80 microgram o.d.

delivered via Concept1 compared to MF 200 microgram o.d., delivered via Twisthaler® in terms of lung function and symptom control in poorly (ie inadequately) controlled asthma patients. This study was to assess contribution of LABA as an add-on therapy to low dose ICS monotherapy.


Options:
A: Mean Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 24 (Baseline (pre-dose at Day 1) and Week 24)
B: Trough FEV1 (week 12)
C: The primary efficacy endpoint is the change in pre dose Forced Expiratory Volume in one second (FEV1) from baseline to 2-hours post dose FEV1 at Week 12. (12 weeks)
D: Model Predicted Change From Baseline Trough Force Expiratory Volume in 1 Second (FEV1) (Baseline (Day 1) and Day 15 of each treatment period); Percentage of Chance That FF 100 mcg Alone Corrected Change From Baseline FEV1 Response Would Exceed a Target Response by Dose of UMEC Combined With FF 100 mcg (Baseline (Day 1) and Day 15 of each treatment period); Mean Change From Baseline in Trough FEV1 on Day 15 of Each of the 3 Treatment Periods (Baseline (Day 1) and Day 15 of each treatment period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: PCAR-119 Bridge Immunotherapy Prior to Stem Cell Transplant in Treating Patients With CD19 Positive Relapsed or Refractory Leukemia and Lymphoma
Brief Summary: The purpose of this study is to evaluate the safety and optimal dose of PCAR-119 in patients who are going to receive stem cell transplantation but without available treatment to achieve complete remission prior to the transplant.


Options:
A: Phase I Escalation - Safety (incidence of Grade 3-5 toxicities) and identification of recommended Phase II dose and schedule. (Within 75 days of AUTO3 infusion); Phase I Expansion - Safety (incidence of Grade 3-5 toxicities) in the outpatient / ambulatory care setting (Within 75 days of AUTO3 infusion); Phase II - Overall response rate as per Lugano criteria (Up to 2 years)
B: Adverse events attributed to the administration of the anti-CD19 CAR-NK cells (2 years)
C: Death Within 8 Weeks of the Study Cell Infusion Thought to be Definitely or Probably Related to Chimeric Antigen Receptor (CAR) T Cell Therapy (Within 8 weeks of the study cell infusion); Dose Limiting Toxicities (30 days); Objective Response Rate of Complete Response and Partial Response (Up to 1 year); Overall Survival (Up to 1 year); Progression Free Survival (Up to 1 year)
D: Phase 1: Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0 (4 weeks); Phase 2: Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm (8 weeks); Phase 2: Comparison of overall complete remission rate for the two arms (One year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: ED Ultrasonographic Regional Anesthesia to Prevent Incident Delirium in Hip Fracture Patients (EDU-RAPID) Multi-center Stepped Wedge Cluster Randomized Trial
Brief Summary: Hip fractures are common, costly and affect older people - Canadians spend 1 billion dollars to treat hip fractures each year. Unfortunately, as many as two-thirds of hip fracture cases suffer a complication known as delirium, or acute confusion. Patients with delirium may become frightened and agitated. This in turn leads to other serious problems. Having delirium doubles the chances of dying or can increase the need for admission into a nursing home. People with delirium spend an extra week in hospital on average.

Using ultrasound to locate and 'freeze' or block specific nerves can stop hip fracture pain almost immediately, and use of this technique is known to reduce delirium when administered by Anaesthetists to patients at the time of their hip operation. Unfortunately, patients with hip fractures commonly wait hours or even days in the Emergency Department (ED) prior to their operation. Currently, these patients are given narcotic pain killers like morphine to dull their pain, as most ED physicians have not been trained in using this 'freezing' technique and Anaesthetists are rarely able to leave the operating room to administer freezing to patient in the ED.

The EDU-RAPID study will test whether training ED physicians on how to use the nerve freezing technique will reduce the number of patients who develop delirium after a hip fracture. To study this, ED physicians will be trained at 6 hospitals in small groups every 6 weeks over 18 months. The study will look at how patients who are treated by ED physician who has been trained compare to patients treated by a ED physician who has not yet been trained. Also, the study will see if the training motivates ED physicians to use the block regularly.

If correct, this study could significantly improve the comfort, quality of life, and independence of patients who suffer a hip fracture. In addition, if the study shows a reduction in delirium rates, this could represent a significant cost reduction to the health care system.


Options:
A: Consumption of opioids
B: Overall rate of incident delirium (Time of injury to post-injury day 7); Time to onset of incident delirium (Time of injury to post-injury day 7)
C: Pain (3 hours)
D: Pain score during positioning (Group 1: 20 minutes after intervention (block), Group 2: 5 minutes after intervention (fentanyl))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Double Blind Comparison of Atosiban in Patients With Repeated Implantation Failure Undergoing IVF Treatment
Brief Summary: This study intends to carry out a prospective, randomized, double blind and controlled study to compare the influence of Atosiban and placebo on uterine contraction frequency, endometrial blood flow perfusion, oxytocin and serum concentration of PGF2α, embryo implantation rate and clinical pregnancy rate on the RIF population after fresh embryo transfer, so as to further clarify the curative effect of Atosiban in the treatment of RIF and provide evidence-based basis for Atosiban for application in RIF population.


Options:
A: Clinical pregnancy rate (4 weeks after embryo transfer)
B: A difference in the term (37 completed weeks of gestation), singleton live birth rate in women undergoing IVF/ICSI treatment following endometrial biopsy versus control subjects. (Approximately 9 months after completion of the last procedure of the last study participant.)
C: PRIMARY OUTCOME MEASURE:IMPLANTATION RATE; (9 MONTHS)
D: Ongoing pregnancy with fetal heart beat at 10 weeks (10 weeks post ET day)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Double Blind Comparison of Atosiban in Patients With Repeated Implantation Failure Undergoing IVF Treatment
Brief Summary: This study intends to carry out a prospective, randomized, double blind and controlled study to compare the influence of Atosiban and placebo on uterine contraction frequency, endometrial blood flow perfusion, oxytocin and serum concentration of PGF2α, embryo implantation rate and clinical pregnancy rate on the RIF population after fresh embryo transfer, so as to further clarify the curative effect of Atosiban in the treatment of RIF and provide evidence-based basis for Atosiban for application in RIF population.


Options:
A: Rate of OHSS (one month)
B: To investigate whether four months of Metformin treatment before IVF (in-vitro-fertilisation) or ICSI (intra-cytoplasmic sperm injection) will increase clinical pregnancy rate in normal weight PCOS-women (Vaginal ultrasound in pregnancy week 7)
C: Clinical pregnancy rate (4 weeks after embryo transfer)
D: Pregnancy rates (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: MOTIVATional intErviewing to Improve Self-care in Heart Failure Patients (MOTIVATE-HF): Study Protocol of a Three-arm Multicenter Randomized Controlled Trial
Brief Summary: The aims of this study will be to evaluate the effect of motivational interviewing (MI) to improve self-care in heart failure (HF) patients and caregiver contributions to HF self-care. Also this study will evaluate the effect of MI on the following secondary outcomes: In HF patients: HF somatic symptom perception, generic and specific quality of life, anxiety and depression, sleep quality, mutuality with caregiver, hospitalizations, use of emergency services, and mortality; In caregivers: generic quality of life, anxiety and depression, mutuality with patient, preparedness, social support and sleep quality.


Options:
A: Self-care Maintenance in Patients (3 months from the intervention)
B: 1 -Year Survival Probability Rate: Vascular Readmissions or Death (Date of enrollment + 12 months)
C: Patient Activation Measure questionnaire (Patient Activation Measure measured at 18 months)
D: Changes from baseline in patient self-management (Health Education Impact Questionnaire v3.0) every 6 months until study end. (At baseline (0 years) and followed for 2.5 years, for a total of 2 to 6 assessments per subject)

Answer: A