TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Patterned Experience for Preterm Infants
Brief Summary: The PEPI study is designed to provide a patterned feeding experience. By using a regularly occurring and necessary caregiving event, feeding, as the vehicle for the patterned experience, the intervention should be effective at promoting and reinforcing neuronal growth and connections that are critical for neurobehavioral and cognitive function while at the same time being cost effective in its delivery.


Options:
A: Oral feeding performance (20 minutes)
B: Neurobehavioral Assessment of the Preterm Infant (NAPI) (Birth, Transition to by mouth feeding, hospital discharge, 2 mo corrected age)
C: N/A
D: The Median Breast Feeding Score (36-48 hours by video recording)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Adolescent Vaccination in the Medical Home: Established and Innovative Strategies
Brief Summary: In this project, the investigators will develop, implement, and evaluate an adolescent vaccination quality improvement program, with the program designed to encourage adolescents to visit their usual primary care provider to receive vaccinations and other recommended preventive health services. This study will be conducted in different types of primary care settings, such as public, private, and managed care clinics serving adolescent patients of diverse backgrounds, and will provide important information to help guide future public health efforts to achieve high rates of immunization in adolescents.


Options:
A: Percent of adolescents who received ≥ 1 or more needed vaccines or well-care visits (6 months)
B: HPV completion rate (One Year)
C: 1 Dose Coverage of the HPV vaccine series at End of Study Period (12 months); 3 Dose Coverage of the HPV vaccine series at End of Study Period (12 months)
D: 1) Change in up-to-date rates for 19- to 35-month-olds (who needed an immunization at baseline) in collaborative population-based counties compared to practice-based intervention counties (every 6 months for 2 years); 2) Change in percent of children (who needed an immunization at baseline) who received any additional vaccines in each type of intervention county. (every 6 months for two years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Stress Management Among Latinos With Type 2 Diabetes Mellitus
Brief Summary: The primary aims of this study are to:

1. Tailor a diabetes stress management intervention for delivery by community health workers (CHWs) serving an urban Latino population.
2. Investigate the efficacy of the stress management intervention on glycemic control.

   Secondary aims of this study are to:
3. Investigate the efficacy of the stress management intervention on stress hormones, psychosocial functioning, and stress-glucose reactivity.

Study hypothesis:

A CHW-led group-based diabetes education model enhanced with stress management education will improve glycemic control more than CHW-led group-based diabetes education alone.


Options:
A: Change in HbA1c at 12 months (12 months)
B: Hemoglobin A1c (Baseline); Hemoglobin A1c (9 weeks); Hemoglobin A1c (6 months)
C: Change in Glycemic Control (HbA1c) (6 months (baseline to 6 months))
D: Program satisfaction, behavioral and emotional outcomes. (3, 6, 9, 12 months after implementation of intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre, Stratified, Open, Randomized, Comparator-controlled, Parallel-group Phase III Study Comparing Treatment With 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in Patients With Inoperable, Progressive, Somatostatin Receptor Positive Midgut Carcinoid Tumours
Brief Summary: This was a multicenter, stratified, open, randomized, comparator-controlled, parallel-group phase III study comparing treatment with Lutathera plus best supportive care (30 mg Octreotide LAR) to treatment with high dose (60 mg) Octreotide LAR in participants with metastasized or locally advanced, inoperable, somatostatin receptor positive, histologically proven midgut carcinoid tumours with progression despite LAR treatment.


Options:
A: Percentage of Days With Subcutaneous Octreotide as Rescue Medication (16-week DB phase)
B: Progression-Free Survival (PFS) (From randomisation up to the last tumour assessment (scheduled at 96 weeks). Radiological scans were performed every 12 weeks during the first year and every 24 weeks during the second year)
C: Progression Free Survival (PFS) (From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached on 24July2015, assessed up to approximately 34 months)
D: Time to Progression Free Survival (PFS) Based as Per Investigator Using Kaplan-Meier Methodology (Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pelvic Floor Muscle Training Included in General Fitness Classes is Effective in Primary Prevention of Urinary Incontince in Pregnancy. A Randomized Controlled Trial
Brief Summary: To investigate the effect of pelvic floor muscle training taught in a general exercise class during pregnancy to prevent urinary incontinence in nulliparous continent pregnant women.


Options:
A: Change from baseline in ICIQ-Urinary Incontinence Short Form Questionnaire (Week 10-14 gestation (baseline), week 36-39 (after intervention))
B: Body mass index of the offsprings (0-24 postpartum months); Fetus body composition (0-24 postpartum months); Change from baseline in Maternal gestational weight gain (40-42 weeks of gestation); Changes in Baby motor development (0-24 postpartum months); Recovery time to pre-gestational weight (6-12 postpartum months); Glycemia level of the offsprings (0-24 postpartum months); Postpartum depression (0-12 postpartum months); Change from baseline in Body image satisfaction (up to 36 weeks); Changes from baseline in maternal quality of life (up to 36 weeks); Placenta measurements (At delivery)
C: Acceptability of the iball intervention (via qualitative data collection) (16 weeks)
D: Primary outcomes are overall weight gain during pregnancy and proportion of participants exceeding weight gain above IOM recommendations. (week 36-38 of pregnancy)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pelvic Floor Muscle Training Included in General Fitness Classes is Effective in Primary Prevention of Urinary Incontince in Pregnancy. A Randomized Controlled Trial
Brief Summary: To investigate the effect of pelvic floor muscle training taught in a general exercise class during pregnancy to prevent urinary incontinence in nulliparous continent pregnant women.


Options:
A: Change from baseline in ICIQ-Urinary Incontinence Short Form Questionnaire (Week 10-14 gestation (baseline), week 36-39 (after intervention))
B: Proportion of Women Who Meet Definition of Success (8 months)
C: Change in Frequency of Urination After 6-week Intervention (Last Observation Carried Forward) (From Baseline to 6 Weeks); Change in Frequency of Urination From 6 Weeks to 12 Weeks (Last Observation Carried Forward) (Change from 6 weeks to 12 weeks); Change in Frequency of Urination From Baseline to 12 Weeks (Last Observation Carried Forward) (Baseline to 12 weeks)
D: Urinary Incontinence (Prevalence) (6 months postpartum (end of intervention))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pelvic Floor Muscle Training Included in General Fitness Classes is Effective in Primary Prevention of Urinary Incontince in Pregnancy. A Randomized Controlled Trial
Brief Summary: To investigate the effect of pelvic floor muscle training taught in a general exercise class during pregnancy to prevent urinary incontinence in nulliparous continent pregnant women.


Options:
A: Gestational diabetes (20 and 36 weeks pregnancy and 3 months post partum); Gestational diabetes (18 months postpartum)
B: Fecal Incontinence Quality of Life (FIQOL) (baseline (2-weeks post delivery) to completion (12-weeks post delivery))
C: Difference in scores on a pelvic floor knowledge questionnaire at 6 weeks postpartum between intervention and control groups (At 6 weeks post-partum)
D: Change from baseline in ICIQ-Urinary Incontinence Short Form Questionnaire (Week 10-14 gestation (baseline), week 36-39 (after intervention))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-Label, Phase 3 Trial of Brentuximab Vedotin(SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Patients With CD30-Positive Cutaneous T-Cell Lymphoma
Brief Summary: The purpose of this study is to determine objective response rate (ORR), lasting at least 4 months (ORR4), with brentuximab vedotin in participants with cluster of differentiation antigen 30 positive (CD30+) cutaneous T-cell lymphoma \[mycosis fungoides (MF) and primary cutaneous anaplastic large cell lymphoma (pcALCL) \]compared to that achieved with therapy in the control arm.


Options:
A: Percentage of Participants Achieving an Objective Response That Lasts at Least 4 Months (ORR4) (Each Cycle until disease progression, death End of treatment (Median overall follow-up 38.8 months))
B: Overall response rate (complete clinical response [CCR) and partial response [PR]) (35 months after first patient in)
C: Ratio of Response Rates Based on CAILS (Assessment made at Day 1 and every subsequent visit during treatment)
D: overall response rate (every 3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Medication Safety of Elderly Patients in Hospital and Ambulatory Setting Considering the Transitions of Care for Home-cared Patients and Nursing Home Residents
Brief Summary: The purpose of this study is to determine whether additional pharmaceutical care for elderly patients (home-cared patients, nursing-home residents) has a positive impact on drug-related readmissions.


Options:
A: Hospital readmission (30 days)
B: Effects on hospital visits (1 year)
C: Days outside hospital until an eventual first readmission (12 months after hospital discharge)
D: Drug-related readmission (one year after discharge from the cooperating ward)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter Randomized Placebo-controlled Trial to Evaluate the Efficacy of the ELTGOL Technique in the Drainage of Secretions in Patients With Bronchiectasis
Brief Summary: The ELTGOL technique improves mucociliary clearance in adult patients with bronchiectasis.

Primary objective:

-To evaluate the efficacy of ELTGOL in stable state patients with bronchiectasis compared to placebo.

Secondary objectives:

* To evaluate the level of knowledge of airway clearance techniques and adherence to them in patients with bronchiectasis.
* To assess the side effects during the procedure: oxygen desaturation, increased dyspnea and hemoptysis.


Options:
A: To evaluate the efficacy of ELTGOL in stable state patients with bronchiectasis compared to placebo (1 year)
B: Incremental Shuttle Walk Test Chronic Respiratory Disease questionnaire (July 2011)
C: Number of steps on the ActiGraph GT3X+ activity monitor (Seven days)
D: 24 hour sputum volume and assessment of cough severity (Leicester Cough Questionnaire) (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Brief Summary: The purpose of the study is to evaluate whether treatment with ibrutinib as a monotherapy results in a clinically significant improvement in progression free survival (PFS) as compared to treatment with ofatumumab in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)


Options:
A: Progression-free survival (PFS) based on independent review committee (up to 6 years)
B: PFS (Progression Free Survival) by Independent Review Committee (IRC), Limited to the Time of Primary Analysis 06 November 2013 (Analysis was conducted after observing approximately 117 PFS events, which occurred about 18 months after the first subject was enrolled.)
C: Overall response rate (ORR) (84 days after start of the last induction cycle)
D: progression free survival (48 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Salpingectomy During Laparoscopic Hysterectomy on Ovarian Function
Brief Summary: The purpose of this study is to assess the feasibility of performing a randomized clinical trial evaluating the effect of salpingectomy (removal of the fallopian tubes) during laparoscopic hysterectomy on ovarian function. The hypothesis is that removal of the tubes can prevent diseases of the fallopian tubes such as infection, hydrosalpinx (fluid-filled tubes)and additional invasive procedures such as further imaging work-ups and further surgery related to the tubes.


Options:
A: Menopause-related quality of life (Up to 5 years after last surgery)
B: Count of Treatment Responders in the Intent to Treat (ITT) Cohort (3 months)
C: Change from baseline in ovarian function as measured by Anti-Mullerian Hormone (AMH) (AMH blood samples collected prior to surgery at day 1 (the day of the surgery) and at 1 and 3 months after day 1.)
D: Participants With ≥ 50% Reduction in Stress Incontinence Episode Frequency From Baseline to 12 Months Post-treatment; as Assessed by 3 Day Diary (Baseline and 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind Placebo-controlled Study Of The Maintenance Of Efficacy Of Etanercept Plus Dmard(s) Compared With Dmard(s) Alone In Subjects With Rheumatoid Arthritis After Achieving An Adequate Response With Etanercept Plus Dmard(s)
Brief Summary: To compare the maintenance of efficacy of the combination of etanercept 50 mg once weekly plus methotrexate with or without other disease modifying antirheumatic drugs therapy with that of methotrexate with or without other disease modifying antirheumatic drugs therapy at Week 52 in subjects with moderately to severely active rheumatoid arthritis who have achieved low disease activity after 24 weeks of therapy with open label etanercept 50 mg once weekly plus MTX with or without other disease modifying antirheumatic drugs therapy.


Options:
A: RA inflammatory activity over 18 months based on repeated DAS28 measures (over 18 months)
B: Percentage of Subjects With Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) <= 3.2 at Week 104 in RA0055 Period 2 Without Flaring (Week 104 in RA0055 Period 2)
C: Percentage of Participants Who Remained in Low Disease Activity (LDA) (Disease Activity Score in 28 Joints-erythrocyte Sedimentation Rate [DAS28-ESR] <3.2) at Week 52. (Baseline and Week 52)
D: Percentage of Participants Achieving 28 Joint Disease Activity Score (DAS28) Less Than or Equal to (≤) 3.2 at Week 88 (Week 88)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Gum Chewing on Postoperative Ileus After Gynecologic Surgery.
Brief Summary: The investigators are randomizing patients to receive chewing gum (Extra Sugar Free, Spearment) every 4 hours during waking hours for 15 minutes versus standard postoperative care. The investigators then have them fill out a survey in house and 1 week after their surgery that record time to first flatus, hunger, toleration of clear liquids and food and some information about pain, satisfaction, and quality of life. The investigators contact them via phone and email a maximum of three times in order to collect this information. 30 days postoperatively the investigators also contact them and perform a chart review for any postoperative complications.


Options:
A: Time to first bowel movement (patients postoperative in hospital stay (mean 6 days))
B: Time to return to active bowel movements (participants will be followed for the duration of hospital stay)
C: time to flatus (two days)
D: Time to flatus (30 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Program SI! for Preschool Education: A School-Based Randomized Controlled Trial
Brief Summary: Cardiovascular disease continues to be the principal cause of death in the world. At present, the risk factors for cardiovascular disease continue to appear at an earlier age permitting prevention activities and the promotion of healthy habits to focus on children. Numerous studies have shown that these factors can be controlled in children through school-based interventions. At the same time, data shows that there is a persistence of unhealthy lifestyles (ie sedentary lifestyles, the use of tobacco, etc...) that begin in childhood and are perpetuated until adulthood. Therefore, the acquisition of healthy lifestyles should begin as early as possible. The SI Program for Preschool Education is an intervention that is both school and home based designed to improve the habits, knowledge and attitudes in four key areas: Food (diet), Physical Activity, Knowledge of the Body and Managing Emotions. This intervention will be implemented in children from three to five years of age, in their parents and in their teachers. To evaluate the efficacy of this intervention, the principal aim of the phase of evaluations is to quantify the behavior changes in the three groups/populations mentioned. The evaluation has been designed according to the controlled intervention model, in which twenty-four schools from the Community of Madrid will be randomized to implement the Program si! for Preschool Education or to function as control schools.


Options:
A: Mathematical attainment: as measured using the level 13 Progress in Maths test (provided at GL assessment) at the end of the school year (June 2018). (1 hour: Last month of the study (June 2018).)
B: Physical activity opportunities delivered (minutes/week); School environment scores; Height (cm); Weight (kg); Body mass index (kg/m^2); Physical fitness (Fitnessgram (C)); Children's leisure time physical activity (PAQ-C); Children's dietary intake; Physical activity interventions planned
C: Our outcome measure was reduction of screen time (4 waves of data)
D: 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)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Program SI! for Preschool Education: A School-Based Randomized Controlled Trial
Brief Summary: Cardiovascular disease continues to be the principal cause of death in the world. At present, the risk factors for cardiovascular disease continue to appear at an earlier age permitting prevention activities and the promotion of healthy habits to focus on children. Numerous studies have shown that these factors can be controlled in children through school-based interventions. At the same time, data shows that there is a persistence of unhealthy lifestyles (ie sedentary lifestyles, the use of tobacco, etc...) that begin in childhood and are perpetuated until adulthood. Therefore, the acquisition of healthy lifestyles should begin as early as possible. The SI Program for Preschool Education is an intervention that is both school and home based designed to improve the habits, knowledge and attitudes in four key areas: Food (diet), Physical Activity, Knowledge of the Body and Managing Emotions. This intervention will be implemented in children from three to five years of age, in their parents and in their teachers. To evaluate the efficacy of this intervention, the principal aim of the phase of evaluations is to quantify the behavior changes in the three groups/populations mentioned. The evaluation has been designed according to the controlled intervention model, in which twenty-four schools from the Community of Madrid will be randomized to implement the Program si! for Preschool Education or to function as control schools.


Options:
A: BMI and aerobic fitness (1 schoolyear)
B: 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)
C: Change of BMI Z-score for preschoolers (Baseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-up)
D: Difference Between Interventions in Vegetable Intake (One meal per week for each intervention (Study weeks 1, 2, 3, and 4))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Program SI! for Preschool Education: A School-Based Randomized Controlled Trial
Brief Summary: Cardiovascular disease continues to be the principal cause of death in the world. At present, the risk factors for cardiovascular disease continue to appear at an earlier age permitting prevention activities and the promotion of healthy habits to focus on children. Numerous studies have shown that these factors can be controlled in children through school-based interventions. At the same time, data shows that there is a persistence of unhealthy lifestyles (ie sedentary lifestyles, the use of tobacco, etc...) that begin in childhood and are perpetuated until adulthood. Therefore, the acquisition of healthy lifestyles should begin as early as possible. The SI Program for Preschool Education is an intervention that is both school and home based designed to improve the habits, knowledge and attitudes in four key areas: Food (diet), Physical Activity, Knowledge of the Body and Managing Emotions. This intervention will be implemented in children from three to five years of age, in their parents and in their teachers. To evaluate the efficacy of this intervention, the principal aim of the phase of evaluations is to quantify the behavior changes in the three groups/populations mentioned. The evaluation has been designed according to the controlled intervention model, in which twenty-four schools from the Community of Madrid will be randomized to implement the Program si! for Preschool Education or to function as control schools.


Options:
A: fasting blood glucose (Baseline to 10 months postpartum); weight (body mass index) (Baseline to 10 months postpartum)
B: 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)
C: Change in glycemic control, change in dietary intake (18 months)
D: Change in fruit, vegetable, whole grain in the lunch sack from baseline to 6 weeks, 22 weeks, and 28 weeks (Baseline, 6 weeks, 22 weeks, 28 weeks)

Answer: B