TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Spinal Cord Burst Stimulation for Chronic Radicular Pain Following Lumbar Spine Surgery: A Randomized Double-blind Sham-controlled Crossover Trial
Brief Summary: Spinal cord stimulation (SCS) is a widely applied therapy to treat chronic neuropathic pain, and one of the most common indications is persisting radicular neuropathic pain following lumbar spine surgery. In traditional SCS therapies, the objective has been to replace the pain sensation with paresthesia. The anticipation is that the electrical current alters pain processing by masking the sensation of pain with a comfortable tingling or paresthesia. Although patients mostly cope with paresthesia, a significant proportion reports that the sensation is unpleasant.

'Burst' SCS utilizes complex programming to deliver high-frequency stimuli. This SCS technique seems to provide paresthesia-free stimulation, resulting in better pain relief of low back and leg pain then traditional tonic stimulation.

The widespread use of SCS has not been backed by solid evidence. The absence of placebo-controlled trials has long been an important point of criticism, but due to the nature of the intervention with sensation of paresthesia, studies with placebo control have so far not been considered possible. When 'burst' SCS is used the stimulation is often unnoticed by the patient, allowing comparison with placebo stimulation.

The aim of this randomized double-blind sham-controlled crossover trial is to evaluate the efficacy of 'burst' spinal cord stimulation for chronic radicular pain following spine surgery.


Options:
A: Proportion of Subjects With 50% or Greater Reduction in Overall Pain Intensity From Baseline (90 days post activation)
B: Change from baseline in disease-specific functional outcome between active burst stimulation and placebo stimulation periods (12 months)
C: Composite of Safety and Effectiveness (3 months)
D: Percent pain relief obtained during the one-month follow-up compared to baseline; The magnitude of change in other indexes of function, such as MPI, during the one-month follow-up period

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Antenatal Corticosteroid in Twin Neonates With Late Preterm Birth: Study Protocol for a Randomized Controlled Trial
Brief Summary: This study will be the first study that evaluates the effectiveness of antenatal corticosteroid (ACS) in late preterm twin neonates.


Options:
A: Incidence of respiratory morbidity (72 hours after birth)
B: Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity) (Birth to 28 days)
C: To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform manner (Longitudinal database currently funded through 3/31/2030)
D: Neonatal Composite Outcome (72 hours of life)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Antenatal Corticosteroid in Twin Neonates With Late Preterm Birth: Study Protocol for a Randomized Controlled Trial
Brief Summary: This study will be the first study that evaluates the effectiveness of antenatal corticosteroid (ACS) in late preterm twin neonates.


Options:
A: severe RDS defined as need for exogenous intra-tracheal surfactant in the first 48 hours of life (48 hours of life)
B: Neonatal Composite Outcome (72 hours of life)
C: Incidence of respiratory morbidity (72 hours after birth)
D: Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity) (Birth to 28 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Antenatal Corticosteroid in Twin Neonates With Late Preterm Birth: Study Protocol for a Randomized Controlled Trial
Brief Summary: This study will be the first study that evaluates the effectiveness of antenatal corticosteroid (ACS) in late preterm twin neonates.


Options:
A: MACS: Perinatal or neonatal mortality or serious neonatal morbidity; MACS-5: Mortality or survival with severe neuro-morbidities at 5 years of age
B: Intact survival without RDS and/or severe (gr 3-4) ICH; Follow-up study at corrected age of two years
C: Composite outcome: including neonatal mortality/stillbirth, severe RDS, chronic lung disease, grade III/IV IVH, PVL
D: Incidence of respiratory morbidity (72 hours after birth)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Antenatal Corticosteroid in Twin Neonates With Late Preterm Birth: Study Protocol for a Randomized Controlled Trial
Brief Summary: This study will be the first study that evaluates the effectiveness of antenatal corticosteroid (ACS) in late preterm twin neonates.


Options:
A: Measurements of Functional Residual Capacity in Preterm Infants. (Within first 72 hours after birth); Measurements of Respiratory Compliance (Crs) in Preterm Infants. (Within first 72 hours after birth)
B: Incidence of respiratory morbidity (72 hours after birth)
C: Neonatal Composite Outcome (72 hours of life)
D: Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity) (Birth to 28 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Antenatal Corticosteroid in Twin Neonates With Late Preterm Birth: Study Protocol for a Randomized Controlled Trial
Brief Summary: This study will be the first study that evaluates the effectiveness of antenatal corticosteroid (ACS) in late preterm twin neonates.


Options:
A: Neonatal Composite Outcome (72 hours of life)
B: Incidence of respiratory morbidity (72 hours after birth)
C: To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform manner (Longitudinal database currently funded through 3/31/2030)
D: Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity) (Birth to 28 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Antenatal Corticosteroid in Twin Neonates With Late Preterm Birth: Study Protocol for a Randomized Controlled Trial
Brief Summary: This study will be the first study that evaluates the effectiveness of antenatal corticosteroid (ACS) in late preterm twin neonates.


Options:
A: Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity) (Birth to 28 days)
B: Incidence of respiratory morbidity (72 hours after birth)
C: Neonatal Composite Outcome (72 hours of life)
D: combined rate of mortality and neurodevelopmental disability in survivors at a corrected age of 18 months. (corrected age of 18 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Antenatal Corticosteroid in Twin Neonates With Late Preterm Birth: Study Protocol for a Randomized Controlled Trial
Brief Summary: This study will be the first study that evaluates the effectiveness of antenatal corticosteroid (ACS) in late preterm twin neonates.


Options:
A: Neonatal Composite Outcome (72 hours of life)
B: Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity) (Birth to 28 days)
C: Incidence of respiratory morbidity (72 hours after birth)
D: Cerebral tissue oxygen saturation during first 72 hours of life (during first 72 hours of life)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Antenatal Corticosteroid in Twin Neonates With Late Preterm Birth: Study Protocol for a Randomized Controlled Trial
Brief Summary: This study will be the first study that evaluates the effectiveness of antenatal corticosteroid (ACS) in late preterm twin neonates.


Options:
A: Incidence of respiratory morbidity (72 hours after birth)
B: Need for mechanical ventilation
C: Death or Chronic Lung Disease (at 36 weeks postmenstrual age); Death (36 weeks adjusted age)
D: Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity) (Birth to 28 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Testing Means to Scale Early Childhood Development Interventions in Rural Kenya
Brief Summary: This study aims to experimentally test the effectiveness and cost-effectiveness of competing models of delivery of an Early Childhood Development (ECD) intervention in rural Kenya to determine how to maximize their reach to improve child cognitive, language and relevant psychosocial outcomes. The study will also include a longer-term evaluation of sustained impacts; an examination of the pathways of change leading to intervention impacts to inform policy; and examination of the role of paternal involvement on child development. Findings will provide policy makers with rigorous evidence of how best to expand ECD interventions in low-resource rural settings to improve child developmental outcomes for both the short-and longer-term.


Options:
A: Child Developmental Outcomes (Month 11/Endline after end of Phase 1's 16 biweekly sessions (Arm 1 with & without fathers, Arm 2 with and without fathers, and Arm 3). Arms A and B created after the Month 11/Endline survey.); Child Developmental Outcomes (Month 35-37/Follow-Up survey (Arms 3, A and B), two years after end of Phase 1's 16 biweekly sessions); Parenting Practices (HOME Observation for Measurement of the Environment - HOME) (Month 11/Endline survey (Arm 1 with and without fathers, Arm 2 with and without Fathers, Arm 3).); Parenting Practices (HOME Observation for Measurement of the Environment - HOME) (Month 35-37 Follow-up Survey (Arms 3, A and B).)
B: Change in Child Protection (Baseline, 12 months, 24 months); Change in Exposure to Child Abuse (Baseline, 12 months, 24 months)
C: Baby's health status (6 days after birth; 6 months after birth; 12 months after birth)
D: Diabetes-related distress (6-week (immediate post-intervention) [T1]); Diabetes-related distress (6-month [T2]); Diabetes-related distress (12-month [T3])

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Subject-Masked, Active-Controlled, Parallel-Arm Clinical Trial Comparing Erector Spinae and Paravertebral Nerve Blocks
Brief Summary: Following painful surgical procedures of the breast, postoperative analgesia is often provided with a paravertebral nerve block (PVB). For intense, but shorter-duration acute pain, a single-injection of local anesthetic is used with a duration of approximately 12 hours. The PVB has several limitations: it can decrease blood pressure, and very rare-but serious-complications have occurred, including neuraxial injection, neuraxial hematoma, and pleural puncture. An alternative block has been described: the erector spinae plane block. The theoretical benefits include ease of administration since it is a plane superficial to the PVB and therefore easier to identify and target with ultrasound (therefore increasing success rate); and an increased safety margin: there are few anatomic structures in the immediate area which could be injured with the needle; and, the target plane is much further from the intrathecal/epidural space relative to the PVB. Lastly, the plane may be easier to catheterize for continuous peripheral nerve blocks relative to the relatively-small volume PVB.

There are therefore multiple theoretical reasons to prefer the erector spinae plane block. Unfortunately, it remains unknown if the analgesia provided by this new technique is comparable to that provided with the PVB. The investigators therefore propose to compare these two techniques with a randomized, subject-masked, active-controlled, parallel-arm, human subjects clinical trial.


Options:
A: QoR 15 score (24 hours post operatively)
B: Numeric Rating Scale Pain Scores (1 day (PACU pain scores)); OR and PACU Opioid Consumption (up to 1 day, in the OR and PACU)
C: Morphine consumption (24 hours postoperatively.)
D: Morphine consumption (postoperative first 24 hour)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Subject-Masked, Active-Controlled, Parallel-Arm Clinical Trial Comparing Erector Spinae and Paravertebral Nerve Blocks
Brief Summary: Following painful surgical procedures of the breast, postoperative analgesia is often provided with a paravertebral nerve block (PVB). For intense, but shorter-duration acute pain, a single-injection of local anesthetic is used with a duration of approximately 12 hours. The PVB has several limitations: it can decrease blood pressure, and very rare-but serious-complications have occurred, including neuraxial injection, neuraxial hematoma, and pleural puncture. An alternative block has been described: the erector spinae plane block. The theoretical benefits include ease of administration since it is a plane superficial to the PVB and therefore easier to identify and target with ultrasound (therefore increasing success rate); and an increased safety margin: there are few anatomic structures in the immediate area which could be injured with the needle; and, the target plane is much further from the intrathecal/epidural space relative to the PVB. Lastly, the plane may be easier to catheterize for continuous peripheral nerve blocks relative to the relatively-small volume PVB.

There are therefore multiple theoretical reasons to prefer the erector spinae plane block. Unfortunately, it remains unknown if the analgesia provided by this new technique is comparable to that provided with the PVB. The investigators therefore propose to compare these two techniques with a randomized, subject-masked, active-controlled, parallel-arm, human subjects clinical trial.


Options:
A: Morphine consumption (24 hour postoperatively)
B: Numeric Rating Scale Pain Scores (1 day (PACU pain scores)); OR and PACU Opioid Consumption (up to 1 day, in the OR and PACU)
C: Morphine consumption (postoperative first 24 hour)
D: Pain scores (1st, 2nd, 4th, 8th, 16th, 24th and 48th hours after surgery)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Role of Low Lactose Infant Formula In The Management of Neonatal Abstinence Syndrome
Brief Summary: Currently Morphine and or Methadone are the most commonly used drugs in the treatment for NAS along with supportive care. Many care providers offer tolerance "low lactose" formula to these infants to alleviate gastrointestinal symptoms. There are no clinical studies to support this practice and it is currently unknown that low lactose formula really helps or not in management of NAS.

This is a Randomized Double Blind Clinical Trial to assess the role of low lactose formula versus standard (regular) formula in managing NAS.


Options:
A: Length of Hospital Stay (LOS) (Participants will be monitored during their entire hospitalization, expected mean 22 days.)
B: Hospital length of stay (Up to hospital discharge, an anticipated average of 4 weeks)
C: Length of Treatment With Opioid Medication (Up to 12 months)
D: Cumulative dose of morphine required to treat NAS. (14 days of age); Highest dose of morphine required to treat NAS. (14 days of age)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Role of Low Lactose Infant Formula In The Management of Neonatal Abstinence Syndrome
Brief Summary: Currently Morphine and or Methadone are the most commonly used drugs in the treatment for NAS along with supportive care. Many care providers offer tolerance "low lactose" formula to these infants to alleviate gastrointestinal symptoms. There are no clinical studies to support this practice and it is currently unknown that low lactose formula really helps or not in management of NAS.

This is a Randomized Double Blind Clinical Trial to assess the role of low lactose formula versus standard (regular) formula in managing NAS.


Options:
A: Sublingual Buprenorphine safety and tolerability in the neonate (Index hospitalization)
B: Number of Participants Administered Morphine Treatment (Participants will be monitored for the duration of their newborn nursery stay, which is an expected mean of 7 days); Cumulative Pharmacological Treatment- Morphine Dose (Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days); Hospitalization Length of Stay (Day of life infants discharged home, which is an expected mean of 21 days.); Hospitalization Length of Stay for Untreated Infants (Day of life untreated infants discharged home, which is an expected mean of 21 days.); Hospitalization Length of Stay for Treated Infants (Day of life treated infants discharged home, which is an expected mean of 21 days.); Length of Pharmacological Treatment-Duration (Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days); Trajectory of Symptom Severity Among Treated Infants (Day of life infant started morphine treatment); Velocity of Weight Gain (Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days); Neurobehavioral Outcomes Assessment (6 month and 12 months of life)
C: Child's Head Circumference Measurement (Measured at Birth) (birth); Child's Length of Hospital Stay (delivery until hospital discharge (min=2 days, max=79 days)); Number of Children Requiring Treatment for Neonatal Abstinence Signs (NAS) (From birth until hospital discharge (min=4 days, max=10, depending on site)); Child's Peak Daily Total NAS Score (minimum twice daily from birth until NAS no longer measured (min=10 days)); Total Amount of Morphine Sulfate That a Neonate Receives to Treat NAS (Start of NAS treatment until discontinuation of NAS treatment (min=0 days, max=76 days))
D: Cumulative dose of morphine required to treat NAS. (14 days of age); Highest dose of morphine required to treat NAS. (14 days of age)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Role of Low Lactose Infant Formula In The Management of Neonatal Abstinence Syndrome
Brief Summary: Currently Morphine and or Methadone are the most commonly used drugs in the treatment for NAS along with supportive care. Many care providers offer tolerance "low lactose" formula to these infants to alleviate gastrointestinal symptoms. There are no clinical studies to support this practice and it is currently unknown that low lactose formula really helps or not in management of NAS.

This is a Randomized Double Blind Clinical Trial to assess the role of low lactose formula versus standard (regular) formula in managing NAS.


Options:
A: Change in Infant Movement between Mattress ON and Mattress OFF (control) (Single sessions throughout course of hospitalization. Each session may last up to 24 hours.); Change in Infant Breathing between Mattress ON and Mattress OFF (control) (Single sessions throughout course of hospitalization. Each session may last up to 24 hours.); Change in Infant Heart Rate between Mattress ON and Mattress OFF(control) (Single sessions throughout course of hospitalization. Each session may last up to 24 hours.)
B: Change in Heart Rate (Change in average heart rate over the 20 minute sessions (both control and music therapy)); Change in Heart Rate Variability (Change in average heart rate variability over the 20 minute sessions (both control and music therapy)); Change in Sleeping Patterns (Change in phase of sleep over the 20 minute sessions (both control and music therapy)); Change in Feeding Patterns (Time from feeding to onset of sleep over the 20 minute session (both control and music therapy)); Morphine Utilization (From day of birth through day of discharge, up to 6 months); Total Length of Stay (From day of birth through day of discharge, up to 6 months)
C: Cumulative dose of morphine required to treat NAS. (14 days of age); Highest dose of morphine required to treat NAS. (14 days of age)
D: Child's Head Circumference Measurement (Measured at Birth) (birth); Child's Length of Hospital Stay (delivery until hospital discharge (min=2 days, max=79 days)); Number of Children Requiring Treatment for Neonatal Abstinence Signs (NAS) (From birth until hospital discharge (min=4 days, max=10, depending on site)); Child's Peak Daily Total NAS Score (minimum twice daily from birth until NAS no longer measured (min=10 days)); Total Amount of Morphine Sulfate That a Neonate Receives to Treat NAS (Start of NAS treatment until discontinuation of NAS treatment (min=0 days, max=76 days))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Physical Therapy Interventions Directed at the Low Back Versus Low Back and Hips for Individuals With a Primary Complaint of Low Back Pain: A Randomized Clinical Trial
Brief Summary: Low back pain (LBP) is the leading cause of disability worldwide and has substantial impacts on pain and function for an individual. Some individuals with LBP seek physical therapy for their condition. The purpose of the study is to determine whether individuals with LBP have improved pain and disability following physical therapy targeting either the low back only or low back plus hip(s).


Options:
A: Sick leave (2 years)
B: Change from baseline on the Modified Oswestry Disability Index (ODI) (Baseline, 2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months); Change from baseline on the Numeric Pain Rating Scale (NPRS) (Baseline, 2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months)
C: Oswestry Disability Index (3 months)
D: Modified Oswestry Disability Index (12 months)

Answer: B