TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Program SI! for Cardiovascular Health Promotion for Elementary Students Aged 6 to 11: a Cluster Randomized Trial
Brief Summary: The objective of the study is to evaluate the effects of Program SI! for Elementary in different times of exposure for childrens and their immediate environment (teachers and parents). For this purpose, 48 public schools from the Community of Madrid-South Area (Spain) were randomly assigned to Program SI! during 3 or 6 academic years (intervention group) or keep their normal curriculum (control group). The main outcome is 3-year, and 6-year changes from baseline of questionnaire scoring of children, their parents and teachers in regards to a healthy lifestyle. For children were included 3-year, and 6-year changes of cardiovascular markers derived from blood pressure and anthropometry.


Options:
A: Percent Body Fat (Baseline and One year)
B: BMD total body, femoral neck and lumbar spine (L2-L4) measured by Dual Energy X Ray Absorbtiometry (15 years)
C: Total daily physical activity (Change between baseline and post-intervention (12 weeks) and 4-months post-intervention)
D: Difference between control and intervention groups in the mean change in questionnaire's scoring from baseline to 3-year and 6-year intervention for children. (3-year, and 6-year changes from baseline of questionnaire scoring for children); Cardiovascular health markers (blood pressure, height, weight, waist circumference and triceps and subscapular skinfold thickness) of children from baseline to 3-year and 6-year intervention. (3-year, and 6-year changes from baseline on cardiovascular health markers of children)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Lao Zinc Study: The Effects of Two Forms of Daily Preventive Zinc Supplementation Versus Therapeutic Zinc Supplementation for Diarrhea on Young Children's Physical Growth and Risk of New Episodes of Diarrhea
Brief Summary: The study will be conducted as a community-based, randomized, placebo-controlled, trial with four study groups. The overall objective of the study is to determine the optimal method for delivering zinc to young children, both for the prevention of zinc deficiency and treatment of diarrhea. In particular, the investigators plan to compare the impact on physical growth, morbidity, micronutrient status, immune function, environmental enteric dysfunction, parasite burden and hair cortisol concentration of: 1) daily preventive zinc supplementation as a micronutrient powder (MNP); 2) placebo powders; 3) daily preventive zinc supplementation as dispersible tablets; 4) therapeutic zinc supplementation as dispersible tablets given in relation to episodes of diarrhea.

In addition to the major outcomes mentioned above, the investigators will monitor adherence to the interventions, neuro-behavioral development, and the occurrence of any adverse events.


Options:
A: Hemoglobin (Start of study (T=0), End of study (T=4months))
B: "negative nutritional outcome" of a child (6 months follow-up)
C: Change in length and length-for-age Z-score (36 weeks); Change in weight and weight-for-age Z-score (36 weeks); Incidence of diarrhea (36 weeks); Change in hemoglobin concentration (32 weeks); Change in micronutrient status (32 weeks); Innate and adaptive immune defense (32 weeks)
D: Birth weight (Within 48 hours (or back calculated from later measurements).); Birth length (Within 48 hours (or back calculated from later measurements)); Child linear growth status at 24 months (24 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Lao Zinc Study: The Effects of Two Forms of Daily Preventive Zinc Supplementation Versus Therapeutic Zinc Supplementation for Diarrhea on Young Children's Physical Growth and Risk of New Episodes of Diarrhea
Brief Summary: The study will be conducted as a community-based, randomized, placebo-controlled, trial with four study groups. The overall objective of the study is to determine the optimal method for delivering zinc to young children, both for the prevention of zinc deficiency and treatment of diarrhea. In particular, the investigators plan to compare the impact on physical growth, morbidity, micronutrient status, immune function, environmental enteric dysfunction, parasite burden and hair cortisol concentration of: 1) daily preventive zinc supplementation as a micronutrient powder (MNP); 2) placebo powders; 3) daily preventive zinc supplementation as dispersible tablets; 4) therapeutic zinc supplementation as dispersible tablets given in relation to episodes of diarrhea.

In addition to the major outcomes mentioned above, the investigators will monitor adherence to the interventions, neuro-behavioral development, and the occurrence of any adverse events.


Options:
A: L:M ratio at 1.5 months (1.5 months)
B: Change in length and length-for-age Z-score (36 weeks); Change in weight and weight-for-age Z-score (36 weeks); Incidence of diarrhea (36 weeks); Change in hemoglobin concentration (32 weeks); Change in micronutrient status (32 weeks); Innate and adaptive immune defense (32 weeks)
C: Fetal loss, low birth weight and pre-term birth. (Delivery)
D: - To measure the impact of zinc and vitamin A on the duration of diarrheal illness (Weekly home visits for 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Text Message Reminders for Influenza Vaccine in Pregnancy
Brief Summary: Influenza virus accounts for numerous cases (epidemics) of respiratory illnesses each year worldwide and affects people of all ages. These epidemics typically occur in the winter months, and can result in substantial morbidity and mortality in persons at risk. Pregnant women may be more susceptible to morbidity and mortality associated with influenza infection. This increased risk may result from several factors including increased heart rate, stroke volume, and oxygen consumption, decreased lung capacity, and changes in immunologic function. Immunization of women during pregnancy can help to prevent infection in the woman herself and may also offer protection to the infant in two ways: by the passage of antibodies from mother to the fetus during pregnancy, and by preventing infection in the mother and therefore decreasing the infant's exposure risk after birth. In Canada, the National Advisory Committee on Immunization (NACI) recommends the vaccine for pregnant women who are expected to deliver during influenza season because they will become household contacts of their newborn. Ideal timing of vaccination occurs in October or November since influenza outbreaks typically occur throughout the winter months. Despite the Canadian and American guidelines for influenza vaccination during pregnancy, it is unclear how many women are offered and/or actually receive the vaccine while pregnant. There is, however, evidence that women will accept the vaccine if offered. Specifically, in the Women's Health Care Centre at St. Michael's Hospital, it was found that 42% of women not only accepted but also received the influenza vaccination when offered. Innovative techniques will be required to continue to increase vaccination rates among vulnerable populations, including pregnant women. The purpose of the present study is to determine if the use of electronic reminders (text messages) increases the likelihood of receiving the influenza vaccine among pregnant women.


Options:
A: Influenza Immunization: Pediatric (March 31, 2011); Influenza Immunization: Pregnant Women (by December 31, 2011); Influenza Immunization: Delayed Pediatric (March 31, 2012)
B: Prevalence of Influenza Vaccination of those who do receive text message reminders compared to those who do not. (Up to 5 months)
C: the first aim is to assess our ability to enroll at least 70% (N=90) of eligible parents in a text messaging program (up to 1 year)
D: new immunization doses (within 60 days of reminder notification)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Text Message Reminders for Influenza Vaccine in Pregnancy
Brief Summary: Influenza virus accounts for numerous cases (epidemics) of respiratory illnesses each year worldwide and affects people of all ages. These epidemics typically occur in the winter months, and can result in substantial morbidity and mortality in persons at risk. Pregnant women may be more susceptible to morbidity and mortality associated with influenza infection. This increased risk may result from several factors including increased heart rate, stroke volume, and oxygen consumption, decreased lung capacity, and changes in immunologic function. Immunization of women during pregnancy can help to prevent infection in the woman herself and may also offer protection to the infant in two ways: by the passage of antibodies from mother to the fetus during pregnancy, and by preventing infection in the mother and therefore decreasing the infant's exposure risk after birth. In Canada, the National Advisory Committee on Immunization (NACI) recommends the vaccine for pregnant women who are expected to deliver during influenza season because they will become household contacts of their newborn. Ideal timing of vaccination occurs in October or November since influenza outbreaks typically occur throughout the winter months. Despite the Canadian and American guidelines for influenza vaccination during pregnancy, it is unclear how many women are offered and/or actually receive the vaccine while pregnant. There is, however, evidence that women will accept the vaccine if offered. Specifically, in the Women's Health Care Centre at St. Michael's Hospital, it was found that 42% of women not only accepted but also received the influenza vaccination when offered. Innovative techniques will be required to continue to increase vaccination rates among vulnerable populations, including pregnant women. The purpose of the present study is to determine if the use of electronic reminders (text messages) increases the likelihood of receiving the influenza vaccine among pregnant women.


Options:
A: Difference in Number and proportion of adults responding to standard appointment versus intense follow up. (2 weeks)
B: Prevalence of Influenza Vaccination of those who do receive text message reminders compared to those who do not. (Up to 5 months)
C: Excessive weight gain (0-6 months)
D: contraceptive continuation (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Text Message Reminders for Influenza Vaccine in Pregnancy
Brief Summary: Influenza virus accounts for numerous cases (epidemics) of respiratory illnesses each year worldwide and affects people of all ages. These epidemics typically occur in the winter months, and can result in substantial morbidity and mortality in persons at risk. Pregnant women may be more susceptible to morbidity and mortality associated with influenza infection. This increased risk may result from several factors including increased heart rate, stroke volume, and oxygen consumption, decreased lung capacity, and changes in immunologic function. Immunization of women during pregnancy can help to prevent infection in the woman herself and may also offer protection to the infant in two ways: by the passage of antibodies from mother to the fetus during pregnancy, and by preventing infection in the mother and therefore decreasing the infant's exposure risk after birth. In Canada, the National Advisory Committee on Immunization (NACI) recommends the vaccine for pregnant women who are expected to deliver during influenza season because they will become household contacts of their newborn. Ideal timing of vaccination occurs in October or November since influenza outbreaks typically occur throughout the winter months. Despite the Canadian and American guidelines for influenza vaccination during pregnancy, it is unclear how many women are offered and/or actually receive the vaccine while pregnant. There is, however, evidence that women will accept the vaccine if offered. Specifically, in the Women's Health Care Centre at St. Michael's Hospital, it was found that 42% of women not only accepted but also received the influenza vaccination when offered. Innovative techniques will be required to continue to increase vaccination rates among vulnerable populations, including pregnant women. The purpose of the present study is to determine if the use of electronic reminders (text messages) increases the likelihood of receiving the influenza vaccine among pregnant women.


Options:
A: Prevalence of Influenza Vaccination of those who do receive text message reminders compared to those who do not. (Up to 5 months)
B: Smoking Abstinence (3 months)
C: Patient retention in care (12 months)
D: Proportion of women who received a Pap smear within 6 months from the date when the study randomization began. (6 months after randomization of study)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Grenada Heart Project - Community Health Action to Encourage Healthy Behaviors
Brief Summary: The Grenada Heart Project (GHP) conducted an observational study within a randomly selected adult sample of Grenadians in 2008-2009. The aim of the study was to assess the clinical, biological and psychosocial determinants of the cardiovascular health in Grenada, in order to develop and implement a nationwide cardiovascular health promotion program.

The sample of 2,827 adults was randomly selected from the national electronic voter list. The main outcome measures were self-reported cardiovascular disease and behavioral risk factors, anthropometric measures, blood pressure (BP), point-of-care testing for glucose and lipids, and ankle-brachial index. Analysis of the data revealed prevalence rates of obesity, hypertension and diabetes significantly exceeding those seen in the U.S.

Since the completion of this assessment, an additional effort has contributed significantly to the current project. A parallel community health-promotion project was carried out in Cardona, Spain called the "Cardona Integral Fifty-Fifty" project with 80 subjects. The preliminary results of the Cardona study have a shown that peer motivation may significantly improve healthy behaviors and thus modify cardiovascular risk.

The GHP CHANGE community -based intervention aims to promote positive behaviors and focus more on what creates health, rather than what prevents sickness. It is built on the foundations of social support, assessing whether people going through similar challenges will support each other, work together to identify and address barriers to success, and motivate each other to move forward. In this program we test for the impact of promotion of healthy lifestyle behaviors through peer motivation on blood pressure, physical activity, eating behavior, weight, and smoking.


Options:
A: The proportion of participants who have a response to treatment when assessed by change in the symptoms of depressive symptoms measured by Beck Depression Inventory (0 months, 1 month, 6 months)
B: Appetitive aggression (sumscore; 0-60 indicating higher levels) (Change from baseline to 3-5 and 6-9 months post treatment); Current violent behavior (sumscore; 0-96 indicating more acts) (Change from baseline to 3-5 and 6-9 months post treatment)
C: Medical students' empathy (3 months)
D: Composite GHP outcomes health score (baseline); Composite GHP outcomes health score (6 months); Composite GHP outcomes health score (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Community-based Rehabilitation Training After Stroke: a Pilot Randomised Controlled Trial
Brief Summary: A pilot study that will evaluate the feasibility and acceptability of procedures to inform the design and delivery of a definitive RCT of ReTrain (which would assess the clinical and cost effectiveness of ReTrain for stroke survivors).


Options:
A: Timed "up and go" test (the day after intervention completion (max 5 weeks))
B: Change in Rivermead Mobility index (Baseline, 6 months, 9 months); Change in Timed Up and Go Test (Baseline, 6 months, 9 months); Change in Modified Patient Specific Functional Scale (Baseline, 6 months, 9 months); Change in Physical Activity Diary (Baseline, 6 months, 9 months); Change in Physical activity - 7-day accelerometry (Baseline, 6 months, 9 months)
C: VO2-peak, strength, walking, activities of daily living (baseline , after 12 weeks training. Follow-up measurements after 6 months, 1 and 2 years after baseline.)
D: Change in the mean number of steps per day (Baseline, 4 months, 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Community-based Rehabilitation Training After Stroke: a Pilot Randomised Controlled Trial
Brief Summary: A pilot study that will evaluate the feasibility and acceptability of procedures to inform the design and delivery of a definitive RCT of ReTrain (which would assess the clinical and cost effectiveness of ReTrain for stroke survivors).


Options:
A: Will include the accuracy (defined as the difference between the straight line connecting the origin and the target and the line followed by the subject) during reaching. One of the additional outcomes is the time to complete a reaching task.
B: Change of TMS (transcranial magnetic stimulation) measurement of cortical excitability (within 1 month from stroke, 6-8 weeks post-stroke, 6 months post-stroke)
C: Upper Extremity Component of Fugl-Meyer Assessment (week 0, week 2, week 4)
D: Change in Rivermead Mobility index (Baseline, 6 months, 9 months); Change in Timed Up and Go Test (Baseline, 6 months, 9 months); Change in Modified Patient Specific Functional Scale (Baseline, 6 months, 9 months); Change in Physical Activity Diary (Baseline, 6 months, 9 months); Change in Physical activity - 7-day accelerometry (Baseline, 6 months, 9 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Community-based Rehabilitation Training After Stroke: a Pilot Randomised Controlled Trial
Brief Summary: A pilot study that will evaluate the feasibility and acceptability of procedures to inform the design and delivery of a definitive RCT of ReTrain (which would assess the clinical and cost effectiveness of ReTrain for stroke survivors).


Options:
A: Change in Reintegration to Normal Living Index score (Baseline, average of 14 weeks, and 6 months)
B: Functionality in Activities of Daily Living (Changes in Scores Approach) (Baseline, 6 months and 12 months); Quality of Life (Changes in Scores Approach) (Baseline, 6 months and 12 months); Quality of Life (Clinically Significance Approach) (Baseline, 6 months and 12 months)
C: Conners Continuous Performance Test (CPT-II) (1 day); Rey Auditory Verbal Learning Test (RAVLT) (1 day); Spanish phonemic fluency test- PMR (1 day); Digit Span forward Subtest from the Wechsler Adult Intelligence Scale (WAIS-III) (1 day); Digit Span backward Subtest from the Wechsler Adult Intelligence Scale (WAIS-III) (1 day); Letter-Number Sequencing Subtest from the Wechsler Adult Intelligence Scale (WAIS-III) (1 day); Rating Scale for Attentional Behavior (RSAB) (1 week); Prospective and Retrospective Memory Questionnaire (PRMQ) (1 week); Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) (1 week)
D: Change in Rivermead Mobility index (Baseline, 6 months, 9 months); Change in Timed Up and Go Test (Baseline, 6 months, 9 months); Change in Modified Patient Specific Functional Scale (Baseline, 6 months, 9 months); Change in Physical Activity Diary (Baseline, 6 months, 9 months); Change in Physical activity - 7-day accelerometry (Baseline, 6 months, 9 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Community-based Rehabilitation Training After Stroke: a Pilot Randomised Controlled Trial
Brief Summary: A pilot study that will evaluate the feasibility and acceptability of procedures to inform the design and delivery of a definitive RCT of ReTrain (which would assess the clinical and cost effectiveness of ReTrain for stroke survivors).


Options:
A: Ambulatory function measured by the Six Minute Walk Test (Rehabilitation discharge (average 4-5 weeks post admission))
B: Change scores of Montreal Cognitive Assessment (MoCA) (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Wechsler Memory Scale - Third Edition (WMS-III) (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Wechsler Adult Intelligence Scale - Third Edition (WAIS-III) (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Useful Field of View (UFOV) (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Stroop Color-Word 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))
C: Change in Rivermead Mobility index (Baseline, 6 months, 9 months); Change in Timed Up and Go Test (Baseline, 6 months, 9 months); Change in Modified Patient Specific Functional Scale (Baseline, 6 months, 9 months); Change in Physical Activity Diary (Baseline, 6 months, 9 months); Change in Physical activity - 7-day accelerometry (Baseline, 6 months, 9 months)
D: Change in the Reintegration to Normal Living Index (RNL) from baseline (baseline, 12 weeks, 24 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Preparing Family Caregivers of Very Ill Patients for End-of-Life Decision Making
Brief Summary: The overarching goal of the project is to improve the process and experience of surrogate decision-making by family caregivers. Since feeling unprepared to make surrogate decisions is a major contributor to caregiver stress, the primary outcome is caregiver self-efficacy --i.e., caregivers' assessment of how well prepared they feel to serve effectively as a surrogate decision-maker. Through follow-on Renewal funding, we are now also qualitatively examining family caregivers' experience with surrogate decision-making.


Options:
A: Number of Participants Who Used Dual Contraception or Safer Conception Method (Month 12)
B: Self-efficacy (6 weeks)
C: Contraceptive Continuation (4 and 7 months post-enrollment)
D: Change from baseline in asthma knowledge at 2 months, measured by QCALF score (Visit 1 (baseline) and visit 2 (2-month follow-up)); Change from baseline in decisional conflict at 2 months, measured by DCS score (Visit 1 (baseline) and visit 2 (2-month follow-up))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Purpose: to investigate the postoperative outcomes of Retrograde intrarenal surgery versus percutaneous nephrolithotomy in 2 to 4 cm kidney stones.


Options:
A: SFR (3 month)
B: Analgesic demand (Postoperative 24 hours); Stone clearance (3 months)
C: Number of patients stone free SFR 4 (1 month from treatment)
D: The change in urine NGAL/Cr value (2 hours preoperative and 2 hours postoperatively)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Purpose: to investigate the postoperative outcomes of Retrograde intrarenal surgery versus percutaneous nephrolithotomy in 2 to 4 cm kidney stones.


Options:
A: Analgesic demand (Postoperative 24 hours); Stone clearance (3 months)
B: SFR (3 month)
C: Proportion of Patients Passing Their Stone Within 28 Days by Self Report (28 days)
D: The primary objective of this study is to compare the stone-free status after Extracorporeal Shock Wave Lithotripsy (ESWL) and Percutaneous Nephrolithotomy (PCNL) for kidney stones 10-20 mm in size. (Within 3 months of enrollment)

Answer: A