TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Randomized Study of Multicolumn Implantable Lead Stimulation for Predominant Low Back Pain
Brief Summary: The purpose of this study is to compare the effectiveness of spinal cord stimulation (SCS) using the Medtronic Specify® 5-6-5 multicolumn surgical lead plus optimal medical management (OMM) versus OMM alone in patients suffering from predominant low back pain due to failed back surgery syndrome (FBSS).


Options:
A: Visual Analogue Scales for pain back, pain limb, pain general and paresthesia
B: The difference of Visual-analogue scale (VAS) between the experimental group and the control group (13 weeks)
C: Composite of Safety and Effectiveness (3 months)
D: Compare Proportion of Subjects With ≥50% Reduction in Low Back Pain Intensity Between the Treatment Groups (6 months post randomization)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Randomized Study of Multicolumn Implantable Lead Stimulation for Predominant Low Back Pain
Brief Summary: The purpose of this study is to compare the effectiveness of spinal cord stimulation (SCS) using the Medtronic Specify® 5-6-5 multicolumn surgical lead plus optimal medical management (OMM) versus OMM alone in patients suffering from predominant low back pain due to failed back surgery syndrome (FBSS).


Options:
A: Change in regional cerebral blood flow measured with 15O-water Positron Emission. Tomography (PET) (PET is performed at study day 0 (baseline), day 14 and day 35.)
B: Pain intensity according to numeric rating scale (NRS) (3 months after implantation)
C: Compare Proportion of Subjects With ≥50% Reduction in Low Back Pain Intensity Between the Treatment Groups (6 months post randomization)
D: Number of Participants With Composite Endpoint Success (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Motivational Text Messaging Walking Program for Older African Americans
Brief Summary: This study examined the impact of using a motivational mobile text messaging intervention to increase step count among older community-dwelling African Americans. Secondary aims were to study the effects of text messaging on self-reported leisure time exercise behavior.

Hypothesis:

Participants in the motivational mobile text messaging group will have an increase step count after 6-weeks.


Options:
A: Feasibility and acceptability of intervention (2 months)
B: Step Watch - Physical Activity Minutes (12 weeks between baseline and post-intervention follow up)
C: Primary outcome measure was step count (6-weeks)
D: body weight (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Motivational Text Messaging Walking Program for Older African Americans
Brief Summary: This study examined the impact of using a motivational mobile text messaging intervention to increase step count among older community-dwelling African Americans. Secondary aims were to study the effects of text messaging on self-reported leisure time exercise behavior.

Hypothesis:

Participants in the motivational mobile text messaging group will have an increase step count after 6-weeks.


Options:
A: Feasibility of Using Facebook and Text Messaging to Deliver a Physical Activity Program to African American Women (Post Intervention (up to 8 weeks))
B: Measured Body Weight (3 months after the 16-week intervention (T3))
C: Adherence to the pedometer-based physical activity regimen (24 weeks post baseline)
D: Primary outcome measure was step count (6-weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Randomized, Double-blind, 52-week Study to Assess the Safety of NVA237 Compared to QAB149 in Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Have Moderate to Severe Airflow Limitation
Brief Summary: The purpose of the study is to provide long term safety data of NVA237. This study will assess the safety and tolerability of a single dose strength of NVA237.


Options:
A: Safety of Treatment With NVA237 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (28 days)
B: Percentage of Participants Reporting Safety and Tolerability in Terms of Adverse Event (AE) Reporting Rate (52 weeks)
C: Change From Baseline Trough in 24-hour Weighted-mean FEV1 on Treatment Day 84 (Baseline (Day 1) and Day 84)
D: Change From Baseline Trough in 24-hour Weighted-mean FEV1 on Treatment Day 84 (Baseline and Day 84)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Cluster Randomised Trial to Compare Effectiveness of the Combined Use of Indoor Residual Spraying (IRS) and Long-lasting Insecticidal Nets (LLINs) to LLINs Alone for Malaria Prevention in Muleba District, Kagera Region, Tanzania
Brief Summary: The study is a cluster randomised trial to compare the effectiveness of indoor residual spraying (IRS) combined with the use of long lasting insecticidal nets (LLINs) with the effectiveness of LLINs alone for preventing malaria infection and morbidity. The primary outcome measure is prevalence of parasitaemia and anaemia in children aged 0.5-10 years, measured in cross sectional surveys. Secondary outcomes include relative population density for each mosquito vector species, malaria transmission as measured by entomological inoculation rates (EIR) by mosquito vector species, monitoring of resistance markers including kdr, and user acceptability of LLINs compared with IRS.

Findings from this study are expected to inform decision making so that resource utilization can be optimised.


Options:
A: Difference in prevalence of malaria infection in children 0.5-14 years between intervention arms (up to 36 months); Difference in Entomological Inoculation Rate (up to 36 months)
B: Prevalence of malarial infection in children 6 months to 10 years (9 months post randomisation)
C: Cost per case averted in children five years of age and under at health facility level by adding Actellic-IRS (24 months)
D: Malaria Incidence (3 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Cluster Randomised Trial to Compare Effectiveness of the Combined Use of Indoor Residual Spraying (IRS) and Long-lasting Insecticidal Nets (LLINs) to LLINs Alone for Malaria Prevention in Muleba District, Kagera Region, Tanzania
Brief Summary: The study is a cluster randomised trial to compare the effectiveness of indoor residual spraying (IRS) combined with the use of long lasting insecticidal nets (LLINs) with the effectiveness of LLINs alone for preventing malaria infection and morbidity. The primary outcome measure is prevalence of parasitaemia and anaemia in children aged 0.5-10 years, measured in cross sectional surveys. Secondary outcomes include relative population density for each mosquito vector species, malaria transmission as measured by entomological inoculation rates (EIR) by mosquito vector species, monitoring of resistance markers including kdr, and user acceptability of LLINs compared with IRS.

Findings from this study are expected to inform decision making so that resource utilization can be optimised.


Options:
A: Prevalence of malarial infection in children 6 months to 10 years (9 months post randomisation)
B: Malaria Incidence (3 years)
C: Difference in prevalence of malaria infection in children 0.5-14 years between intervention arms (up to 36 months); Difference in Entomological Inoculation Rate (up to 36 months)
D: Cost per case averted in children five years of age and under at health facility level by adding Actellic-IRS (24 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of a Limited Versus Traditional Oxygen Strategy During Resuscitation in Premature Newborns
Brief Summary: Preterm infants are born with immature lungs and often require help with breathing shortly after birth. This traditionally involves administering 100% oxygen. Unfortunately, delivery of high oxygen concentrations leads to the production of free radicals that can injure many organ systems. Term and near-term newborns deprived of oxygen during or prior to birth respond as well or better to resuscitation with room air (21% oxygen) compared to 100% oxygen. However, a static concentration of 21% oxygen may be inappropriate for preterm infants with lung disease.Purpose of the study is to investigate if preterm neonates where resuscitation is initiated with 21% fiO2 and adjusted to meet transitional goal saturations (Limited oxygen strategy or LOX) would have less oxidative stress as measured by the oxidative balance ratio of biological antioxidant potential/total hydroperoxide compared to infants where resuscitation is initiated with pure oxygen and titrated for targeted saturations of 85-94% (Traditional oxygen strategy or TOX). Secondary outcomes of interest included need for other delivery room resuscitation measures, respiratory support and ventilation/oxygenation status upon neonatal intensive care unit (NICU) admission, survival to hospital discharge, bronchopulmonary dysplasia and other short-term morbidities.


Options:
A: Survival Without Bronchopulmonary Dysplasia (BPD) (36 weeks); Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery) (55 weeks)
B: composite outcome of death or major disability by 18-24 months corrected age (by 18-24 months corrected age (gestational age plus chronological age))
C: Survival without severe neurosensory disability to 18 to 21 months (corrected for prematurity) (18-21 months corrected for prematurity)
D: Reduction in mean oxidative balance ratio at 1 hour of life (Cord blood and at 1 hour of life)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: How Volunteer Programs Affect Health and Well-being in Low-income Youth
Brief Summary: This study tested whether getting youth engaged in helping others (volunteering) would benefit youth's physical health. 106 predominantly minority and low socioeconomic status (SES) youth were randomized to either volunteer weekly with elementary school children in after school programs or to a wait-list control group. The investigators hypothesized that cardiovascular risk markers of C-reactive protein (CRP), interleukin-6 (IL-6), total cholesterol, and body mass index (BMI) would be lower at post-intervention (4 months after baseline) in the volunteer group compared to the control group. The investigators also hypothesized that the intervention might work through pathways such as reducing negative mood, improving self esteem, and increasing prosocial behaviors (empathy, altruism).


Options:
A: Change in Physical activity (3 months)
B: Number and Proportion of Participants With Baseline BMI <85th Percentile Who Developed Overweight or Obesity by the End of the Study (Baseline to two years); Change in Physical Activity (Baseline to two years); Change in Reported Added Sugar Intake (Baseline to two years); Change in Reported Fruit, Vegetables, and Legume Intake (Not Including Potatoes) (Baseline to two years); Change in BMI Z-score (Baseline to two years); Change in HOMA-IR (Baseline to two years)
C: Body mass index (Baseline-adjusted post-intervention scores at 4 months); C-reactive protein (Baseline-adjusted post-intervention scores at 4 months); Interleukin-6 (Baseline-adjusted post-intervention scores at 4 months); Total Cholesterol (Baseline-adjusted post-intervention scores at 4 months)
D: Change in Body Mass Index (Baseline, 2, 4, 6, 8, 10, 12, 14, 16, 18, 24 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Negative Pressure Dressing to Decrease the Incidence of Leg Wound Complications After CABG
Brief Summary: This study will test the effectiveness of negative pressure wound therapy (using the VAC Prevena device, KCI Canada Inc.) applied to the saphenous vein harvest site after Coronary Artery Bypass Grafting (CABG). When initiated immediately after surgery, this intervention may decrease the incidence of wound infection and non-infectious wound complications. It may decrease wound discomfort and improve mobility and functional recovery of the leg.


Options:
A: Groin Wound Complication (30 days)
B: Postoperative Surgical Site Infection (SSI) (30 days following operation)
C: Number of Participants With Wound Complications (Four weeks after cesarean section)
D: Change from baseline ASEPSIS score of wound healing at 6 weeks. (Baseline and 6 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Negative Pressure Dressing to Decrease the Incidence of Leg Wound Complications After CABG
Brief Summary: This study will test the effectiveness of negative pressure wound therapy (using the VAC Prevena device, KCI Canada Inc.) applied to the saphenous vein harvest site after Coronary Artery Bypass Grafting (CABG). When initiated immediately after surgery, this intervention may decrease the incidence of wound infection and non-infectious wound complications. It may decrease wound discomfort and improve mobility and functional recovery of the leg.


Options:
A: Number of Participants With Wound Complications (Four weeks after cesarean section)
B: Post-operative Seroma Formation (Two weeks following drain removal)
C: Change from baseline ASEPSIS score of wound healing at 6 weeks. (Baseline and 6 weeks)
D: Incisional Dehiscence (last post operative visit, up to 2 years); Post operative infection (last post operative visit, up to 2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Negative Pressure Dressing to Decrease the Incidence of Leg Wound Complications After CABG
Brief Summary: This study will test the effectiveness of negative pressure wound therapy (using the VAC Prevena device, KCI Canada Inc.) applied to the saphenous vein harvest site after Coronary Artery Bypass Grafting (CABG). When initiated immediately after surgery, this intervention may decrease the incidence of wound infection and non-infectious wound complications. It may decrease wound discomfort and improve mobility and functional recovery of the leg.


Options:
A: Number of Participants With Wound Complications (Four weeks after cesarean section)
B: Surgical Site Infection (30 days)
C: Change from baseline ASEPSIS score of wound healing at 6 weeks. (Baseline and 6 weeks)
D: Number of Participants With Wound Complication (Day of surgery to 30 days postoperative); Number of Participants With Classification of Wound Morbidity (Day of Surgery to 30 days postoperative)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Negative Pressure Dressing to Decrease the Incidence of Leg Wound Complications After CABG
Brief Summary: This study will test the effectiveness of negative pressure wound therapy (using the VAC Prevena device, KCI Canada Inc.) applied to the saphenous vein harvest site after Coronary Artery Bypass Grafting (CABG). When initiated immediately after surgery, this intervention may decrease the incidence of wound infection and non-infectious wound complications. It may decrease wound discomfort and improve mobility and functional recovery of the leg.


Options:
A: Surgical site infection rate (30 days)
B: Post-operative wound infection (6 weeks post-operative)
C: Postoperative Surgical Site Infection (SSI) (30 days following operation)
D: Change from baseline ASEPSIS score of wound healing at 6 weeks. (Baseline and 6 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a Multifactorial Falls Prevention Program in Community-dwelling Older People When Compared to Usual Care: A Randomized, Controlled Trial
Brief Summary: This study is a clinical trial designed to evaluate the effectiveness of a multifactorial falls prevention program in reducing the rate of falls.

A multifactorial falls prevention program consisting of an individualized medical management of the modifiable risk factors, a progressive on-site body balance exercise plus a home-based exercise program, an educational/behavioral intervention and a fall prevention booklet will reduce the number of falls and fall rates when compared with usual care.


Options:
A: rate of falls (12 months); proportion of fallers (12 months)
B: Reduction of frailty (12 months); Frailty score (continuous variable) (12 months); Measures of frailty components (BMI, fast gait speed test, knee extension, exhaustion score and time spent on physical activities per day). (12 months)
C: Falls events (6-months)
D: fall incidence rate

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Open-Label Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
Brief Summary: The purpose of this one year extension (follow-up) study is to gather additional safety data in hypogonadal men treated with oral TU or AndroGel who have completed the 12-month Phase III study CLAR-09007.


Options:
A: Absolute Change From Baseline in T Cholesterol (Approximately 365 days); Absolute Change From Baseline in HDL (Approximately 365 days); Absolute Change From Baseline in LDL (Approximately 365 days); Absolute Change From Baseline in Hgb (Approximately 365 days); Absolute Change From Baseline in Hct (Approximately 365 days); Absolute Change From Baseline in Prostate Volume (Approximately 365 days)
B: Insulin Resistance (40 weeks)
C: Change from baseline on the total score of the AMS rating scale (Month 6)
D: Lean body mass (approximately three years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Physical Activity and Academic Achievement Across the Curriculum (A+PAAC)
Brief Summary: There is currently considerable interest in both improving academic achievement (No Child Left Behind) and reducing the rates of obesity and its associated negative health consequences in elementary school students. Increased physical activity (PA) offers a potential intervention to address both issues. Evidence is available which suggests an association of PA with both academic achievement and obesity, and an association between obesity and academic achievement.

To provide increased PA while maintaining academic instruction time, we developed a program we call "Physical Activity Across the Curriculum" (PAAC) in which regular classroom teachers were trained to deliver academic lessons using moderate to vigorous physical activity (MVPA) for 20 minutes/d, 5 days/wk. This study is looking to compare academic achievement between students in elementary schools that participate in academic lessons taught through MVPA (PAAC) to students that do not (CON).


Options:
A: Changes in Academic Achievement in Elementary Students (Baseline to 3 Years)
B: Skin-fold thickness (1 year)
C: Change in Demographic data (Evaluation at three time points: 0 months, 2 months and 8 months); Goal setting tool (Evaluation at three time points: 0 months, 2 months and 8 months); Changes in 24-hour dietary intake recall (Evaluation at three time points: 0 months, 2 months and 8 months); Changes in 3-day dietary intake record (Evaluation at three time points: 0 months, 2 months and 8 months); Changes in 24-hour physical activity recall (Evaluation at three time points: 0 months, 2 months and 8 months); Changes in 3-day physical activity record (Evaluation at three time points: 0 months, 2 months and 8 months); Changes in Anthropometric measurements (Evaluation at three time points: 0 months, 2 months and 8 months); Changes in Social Cognitive Theory (SCT) variables (Evaluation at three time points: 0 months, 2 months and 8 months); Changes in blood pressure (BP) measurements (Evaluation at three time points: 0 months, 2 months and 8 months)
D: 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).)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Physical Activity and Academic Achievement Across the Curriculum (A+PAAC)
Brief Summary: There is currently considerable interest in both improving academic achievement (No Child Left Behind) and reducing the rates of obesity and its associated negative health consequences in elementary school students. Increased physical activity (PA) offers a potential intervention to address both issues. Evidence is available which suggests an association of PA with both academic achievement and obesity, and an association between obesity and academic achievement.

To provide increased PA while maintaining academic instruction time, we developed a program we call "Physical Activity Across the Curriculum" (PAAC) in which regular classroom teachers were trained to deliver academic lessons using moderate to vigorous physical activity (MVPA) for 20 minutes/d, 5 days/wk. This study is looking to compare academic achievement between students in elementary schools that participate in academic lessons taught through MVPA (PAAC) to students that do not (CON).


Options:
A: Our outcome measure was reduction of screen time (4 waves of data)
B: Area Under the Curve (niAUC) of Perceived Hunger, Fullness, Desire to Eat, and Prospective Food Consumption (5 weeks); Area Under the Curve (AUC) of Plasma Total Ghrelin and Ln Peptide YY (PYY) (5 weeks); Brain Regions Displaying Differential Activation Prior to Dinner in Response to Food vs Nonfood Stimuli From Food Cue-stimulate fMRI Brain Scans (5 weeks)
C: Changes in Academic Achievement in Elementary Students (Baseline to 3 Years)
D: Change in Body Mass Index Percentage (BMI%) (Change from Baseline to 12-Month Post intervention); Change in Healthy Lifestyle Behaviors (Change from Baseline to 12-Month Post intervention); Change in Depression and Anxiety Symptoms (Change from Baseline to 15-Week Post intervention); Social Skills (15-Week Post); Academic Performance (15-Week Post); Change in Body Mass Index Percentile (%) (Change from Baseline to 6-Month post intervention); Change in Healthy Lifestyle Behaviors (Change from Baseline to 6-Month Post intervention); Change in Depression and Anxiety Symptoms (Change from Baseline to 6-Month Post intervention); Change in Depression and Anxiety Symptoms (Change from Baseline to 12-Month Post intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Physical Activity and Academic Achievement Across the Curriculum (A+PAAC)
Brief Summary: There is currently considerable interest in both improving academic achievement (No Child Left Behind) and reducing the rates of obesity and its associated negative health consequences in elementary school students. Increased physical activity (PA) offers a potential intervention to address both issues. Evidence is available which suggests an association of PA with both academic achievement and obesity, and an association between obesity and academic achievement.

To provide increased PA while maintaining academic instruction time, we developed a program we call "Physical Activity Across the Curriculum" (PAAC) in which regular classroom teachers were trained to deliver academic lessons using moderate to vigorous physical activity (MVPA) for 20 minutes/d, 5 days/wk. This study is looking to compare academic achievement between students in elementary schools that participate in academic lessons taught through MVPA (PAAC) to students that do not (CON).


Options:
A: Changes in Academic Achievement in Elementary Students (Baseline to 3 Years)
B: BMI and aerobic fitness (1 schoolyear)
C: Change from baseline in weekly time in moderate-to-vigorous physical activity at 4 months (baseline and after 4-months of intervention); Change from baseline in the daily time using TV/computer/video games at 4 months (baseline and after 4-months of intervention)
D: BMI will be assessed during lifestyle intervention in (1) children and adolescents and (2) adults vs. placebo (21 months)

Answer: A