TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter Randomized Controlled Trial of Epidural Steroid Injections for Spinal Stenosis in Persons 50 and Older
Brief Summary: The broad, long-term objective of this research protocol is to improve the quality of life for patients suffering from lumbar spinal stenosis. This objective will be met by examining the safety and clinical efficacy of epidural steroid injections for treatment of pain associated with lumbar spinal stenosis. This prospective, randomized, double-blind controlled trial (RCT) will test the hypothesis that the effectiveness of epidural steroid injections (ESI) plus local anesthetic (LA) is greater than epidural injections of LA alone in older adults with lumbar spinal stenosis.


Options:
A: Roland Morris (6 weeks)
B: To evaluate for differences between the patients in various groups in the physical function and pain at 1, 3, 6, and 12 months post treatment (1,3,6,12 months)
C: Average Leg Pain at 1 Month Measured Using the Numeric Pain Scale (1 month after the start of treatment); Average Leg Pain at 3 Months Measured Using the Numeric Pain Scale (3 months from the start of treatment); Worst Leg Pain at 1 Month Measured Using the Numeric Pain Scale (1 month from the start of treatment); Worst Leg Pain at 3 Months Measured Using the Numeric Pain Scale (3 months from the start of treatment)
D: Numerical Rating Leg Pain Score (1 month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Guanfacine for the Treatment of Hyperactivity in Pervasive Developmental Disorder
Brief Summary: The purpose of this study is to determine whether guanfacine (trade name Intuniv) by itself or in combination with methylphenidate (also known as Ritalin) is helpful for treating hyperactivity in children and adolescents with a Pervasive Developmental Disorders (PDDs).


Options:
A: Clinical Global Impression - Severity (Week 12); Clinical Global Impression - Improvement (Week 12)
B: Aberrant Behavior Checklist Hyperactivity Subscale (Week 8)
C: Clinical Global Impressions Scale - Improvement - Social (6 Weeks); Repetitive Behavior Scale - Revised (6 Weeks); Diagnostic Analysis of Nonverbal Accuracy, Paralanguage Test (6 Weeks)
D: hyperactivity, impulsiveness, and distractibility

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Guanfacine for the Treatment of Hyperactivity in Pervasive Developmental Disorder
Brief Summary: The purpose of this study is to determine whether guanfacine (trade name Intuniv) by itself or in combination with methylphenidate (also known as Ritalin) is helpful for treating hyperactivity in children and adolescents with a Pervasive Developmental Disorders (PDDs).


Options:
A: Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) T-Score After Treatment. (Baseline; Week 4)
B: Buss-Durkee Hostility Inventory; Barratt Impulsiveness Scale
C: N/A
D: Aberrant Behavior Checklist Hyperactivity Subscale (Week 8)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Guanfacine for the Treatment of Hyperactivity in Pervasive Developmental Disorder
Brief Summary: The purpose of this study is to determine whether guanfacine (trade name Intuniv) by itself or in combination with methylphenidate (also known as Ritalin) is helpful for treating hyperactivity in children and adolescents with a Pervasive Developmental Disorders (PDDs).


Options:
A: Change From Baseline in Social Communication Deficits as Measured by Social Responsiveness Scale 2 (SRS-2) (Baseline, Week 12); Percentage of Participants with Suicidality, as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) (Baseline up to Week 12); Percentage of Participants With Adverse Events (From Baseline up to Week 18)
B: Aberrant Behavior Checklist Hyperactivity Subscale (Week 8)
C: To evaluate the effects of twice-daily oral buspirone on core features of autism in autistic children 2-6 years measuring the change from baseline in ADOS (Autism Diagnostic Observation Schedule) Composite Total scores compared to placebo at 6 months. (Baseline 1, Week 24)
D: Percentage of Participants Who Were Attention Deficit Hyperactivity Disorder (ADHD) Respondents (week 10); Percentage of Participants Who Were Autism Spectrum Disorder Respondents (week 10)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I/II Study of Pazopanib (GW786034) and Cyclophosphamide in Patients With Platinum-resistant Recurrent, Pre-treated Ovarian Cancer
Brief Summary: The current trial shall clarify the potential of the multitarget antiangiogenic tyrosinkinase inhibitor GW 786034 (pazopanib) in combination with oral cyclophosphamide as salvage treatment in patients with recurrent, pretreated ovarian cancer.


Options:
A: Progression free survival (30 months)
B: To determine if AMG 386 plus PLD is superior to placebo plus PLD as measured by progression-free survival, defined as the time from randomization to the earliest of the dates of first radiologic disease progression per RECIST 1.1 with modifications (Radiological imaging will be performed 8 weeks ± 1 week, starting from date of randomization for the first 64 weeks, then every 16 weeks ± 1 week for the next 32 weeks, and then every 24 weeks ± 4 weeks thereafter.)
C: Progression Free Survival (PFS) (Radiologic scans performed at weeks 9 and 18 (+/-1 week) and every 12 weeks thereafter relative to the date of randomisation until the primary analysis (approximately 20 months))
D: Determination of the optimal doses for pazopanib (phase I) (42 months); Overall response rate according to RECIST criteria / clinical benefit (stable disease or partial response or complete response) (phase II) (12 weeks after start of treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Response Variability in Children With ADHD
Brief Summary: Children with Attention Deficit Hyperactivity Disorder (ADHD) have numerous areas of neuropsychological dysfunction including response inhibition, working memory, and attention. One neuropsychological outcome measure that consistently reveals between-group differences is response variability. However, until recently, differences in response variability have been reported as an ancillary finding or viewed as a nuisance in the analyses. The specific aims of the present study are to 1) Examine response variability in ADHD patients across neuropsychological tasks to understand the breadth of this specific deficit and to understand the relation between response variability and other neuropsychological outcome measures; 2) Assess whether response variability deficits are specific to either or both of the two most prevalent ADHD subtypes (i.e., Combined Type \[CT\] and Predominantly Inattentive Type \[PIT\]); 3) Determine whether response variability in ADHD patients is affected by either medication or a variety of environmental manipulations (e.g., reward); and 4) Understand the relationship between neuropsychological measures of response variability and naturalistic instances of variable performance. Forty-five children (aged 7-11) with ADHD-CT, 45 children with ADHD-PIT, and 45 normal controls will be recruited to examine response variability across a wide range of neuropsychological tests. Task parameters such as event rate, stimulus saliency, and the presence of operant reward will be modified on each test to determine the conditions under which response variability is manifested in children with ADHD. In addition, all children with ADHD will participate in a placebo-controlled, randomized medication trial with a psychostimulant medication to assess the effects of medication on response variability. Advanced analytic methods utilizing non-Gaussian distributions and fast Fourier Transforms of the reaction time data will be used to conduct detailed analyses of RT patterns across the ADHD and normal control groups. Further, the effects of task parametric manipulations and medication on response variability will be examined. Finally, relations between response variability on neuropsychological tests and response variability in a variety of real-world analog situations will be examined to evaluate the ecological validity of these deficits.


Options:
A: Attention Deficit / Hyperactivity Disorder Total Sum Score of All 18 ADHD Symptom Items (end of first week, end of second week, end of third week, end of fourth week. Total of 4 weeks.)
B: Total score on the Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale, evaluated by the investigator at the end of the Double-Blind Phase.
C: Number of days of use of cannabis (12 weeks)
D: The primary objective of this study is to evaluate, under controlled conditions, the safety and efficacy of SPD485 (MTS) compared to placebo with reference to CONCERTA®, as determined by the change in the clinician completed ADHD-RS-IV at each visit. (7 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial to Evaluate Efficacy of Nebulized Hypertonic Saline vs. Normal Saline in the Treatment of Hospitalized Children With Bronchiolitis
Brief Summary: The purpose of this study is to evaluate the efficacy of hypertonic saline vs. normal saline in the treatment of infants hospitalized for bronchiolitis, regarding length of hospital stay, oxygen requirements and clinical outcome.


Options:
A: Admission Rate (1 day); Length of Stay (1 month); Change in RDAI Score (1 Hour)
B: Difference in mean Respiratory Assessment Change Score (RACS) between groups in every time considered (Every 4h for three consecutive times beginning in the moment of inclusion in the study and after every 8h for three consecutive times (average of 36h))
C: Hospitalization Days (Participants will be followed for the duration of hospitalization, an expected average of 4 days)
D: Time to 'fit for discharge' (This was judged to be when the infant was feeding adequately [taking >75% of usual intake] and was in air with a saturation of at least 92% for 6 hours, to reflect clinical practice.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma
Brief Summary: The primary objective of the study is to evaluate the effect of multiple-dose subcutaneous administrations of MEDI-563 on adults with uncontrolled asthma.


Options:
A: To understand the mechanisms driving eosinophilia and disease pathogenesis in patients with a wide range of eosinophilic disorders (Ongoing assessment)
B: Annual Asthma Exacerbation Rate (AER) for Eosinophilic Phenotype (EOS+) Participants (Week 1 up to Week 52)
C: Number of Participants With Reduction In Daily Oral Corticosteroid (OCS) Dose During Weeks 20-24 As Compared to the Optimized Dose At Baseline (Baseline (Day 1), Weeks 20-24)
D: Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Screening (Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Screening (Day -14)); Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Day 14 (Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Day 14); Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Day 35 (Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Day 35)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma
Brief Summary: The primary objective of the study is to evaluate the effect of multiple-dose subcutaneous administrations of MEDI-563 on adults with uncontrolled asthma.


Options:
A: Frequency of Clinical Asthma Exacerbations (CAEs) During 12 Months of Treatment (Day 1 to Week 52); Frequency of Each of the Two Criteria for Clinical Asthma Exacerbations (CAEs) (Day 1 to Week 52)
B: Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Screening (Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Screening (Day -14)); Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Day 14 (Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Day 14); Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Day 35 (Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Day 35)
C: Number of Participants With the Indicated Percent Reduction From Baseline in Oral Corticosteroid (OCS) Dose During Weeks 20 to 24 While Maintaining Asthma Control (Baseline; Weeks 20 to 24)
D: Annual Asthma Exacerbation Rate (AER) for Eosinophilic Phenotype (EOS+) Participants (Week 1 up to Week 52)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma
Brief Summary: The primary objective of the study is to evaluate the effect of multiple-dose subcutaneous administrations of MEDI-563 on adults with uncontrolled asthma.


Options:
A: Annual Asthma Exacerbation Rate (AER) for Eosinophilic Phenotype (EOS+) Participants (Week 1 up to Week 52)
B: Identifying new patient subtypes and endpoints for COPD (3 years)
C: Annualized Incidence Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) (Day 1 up to 393)
D: Percentage decrease of sputum eosinophils from baseline (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Parallel, Double-Blind Efficacy and Safety Study of Biphentin Methylphenidate HCl Extended Release Capsules Compared to Placebo in Children and Adolescents 6 to 18 Years With Attention Deficit Hyperactivity Disorder (ADHD)
Brief Summary: This multi-center parallel study is designed to study the efficacy and safety of fixed doses of methylphenidate extended release (ER) capsules of four dose levels compared with a placebo group in pediatric patients with Attention Deficit Hyperactivity Disorder (ADHD) who are between 6 and 18 years old.


Options:
A: Systolic Blood Pressure (Baseline and 6 months); Diastolic Blood Pressure (Baseline and 6 months); Pulse Rate (Baseline and 6 months); Electrocardiogram Results (QTcF Interval) (Baseline and 6 months); Post Sleep Questionnaire (PSQ) Quality of Sleep (6 months); Weight (Baseline and 6 months); Dermal Reactions (6 months)
B: N/A
C: Change in ADHD-RS-IV Total Score From Baseline (Visit 2) to the End of the Double-Blind Phase (Visit 3) (From baseline (visit 2) to end of of Double-Blind phase (visit 3))
D: Total score on the Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale, evaluated by the investigator at the end of the Double-Blind Phase.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Parallel, Double-Blind Efficacy and Safety Study of Biphentin Methylphenidate HCl Extended Release Capsules Compared to Placebo in Children and Adolescents 6 to 18 Years With Attention Deficit Hyperactivity Disorder (ADHD)
Brief Summary: This multi-center parallel study is designed to study the efficacy and safety of fixed doses of methylphenidate extended release (ER) capsules of four dose levels compared with a placebo group in pediatric patients with Attention Deficit Hyperactivity Disorder (ADHD) who are between 6 and 18 years old.


Options:
A: Conners' Global Index - Parent Version (CGI-P) (Once weekly during the medication trial); Conner's Global Index - Teacher Version (CGI-T) (Once weekly during the medication trial)
B: N/A
C: Change in pain ratings (0-100) to a suprathreshold heat pain stimulus (3.5 Minutes after end of infusion)
D: Change in ADHD-RS-IV Total Score From Baseline (Visit 2) to the End of the Double-Blind Phase (Visit 3) (From baseline (visit 2) to end of of Double-Blind phase (visit 3))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Culturally Focused Psychiatric Consultation Service for Asian American and Latino American Primary Care Patients With Depression
Brief Summary: The purpose of this study is to determine if a culturally focused psychiatric (CFP) consultation service can improve depressive symptoms and increase diagnosis and treatment of depression in Asian American and Latino American primary care patients at the Massachusetts General Hospital.


Options:
A: Brief Pain Inventory Interference (Measured at Year 1); HSCL-20 Depression Severity (Measured at Year 1)
B: To determine if a culturally focused psychiatric (CFP) consultation service can improve depressive symptoms and increase diagnosis and treatment of depression in Asian American and Latino American primary care patients at MGH. (6 months after baseline assessment)
C: Compare the effectiveness of a culturally tailored intervention with the effectiveness of a standard intervention by evaluating its impact on patient outcomes (remission of depression, depression symptom level, functional status) at 6 and 12 months.
D: Recovery from Common Mental Disorder (defined by ICD10) (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Research Plan for a Randomised, Single-blind, Parallel Group Controlled Trial in Rural Malawi, Testing the Health Effects of Supplementing Maternal Diet During Pregnancy and Lactation and Infant Diet From 6 to 18 Months of Age With High-energy, Micronutrient Fortified Lipid-based Nutrient Supplements (LNS)
Brief Summary: The use of lipid-based nutrients (LNS), such as Nutributter or fortified spread (FS), have been associated with improved growth and development outcomes among infants in Ghana and Malawi. Modified versions of such supplements have been developed to improve their nutrient density and quality and to lower their costs. Such modified products have proven acceptable to pregnant women in Malawi and Ghana. In the present trial, the investigators aim to test the effect of LNS on pregnancy and child outcomes, when given during pregnant and lactating women and their infants from 6 to 18 months of age. In control groups, participants will receive either iron+folate tables during pregnancy only or multiple micronutrient tablets during pregnancy and first six months of lactations. The main hypothesis to be tested suggests that the mean length-for-age Z-score (LAZ) of 18-month-old infants who received LNS between 6 and 18 months of age and whose mothers were provided with LNS during pregnancy and the first 6 months of lactation is higher than the mean LAZ score of same age infants who received no dietary supplements and whose mothers received iron-folate supplementation during pregnancy only.

To detect the long-term effect of the LNS supplementation, we now propose to conduct a follow-up study when the children are 9 years old, to see if the intervention had effect on children's growth, cardiometabolic and respiratory status and neurocognitive development.


Options:
A: Change in length-for-age Z-score (LAZ, based on WHO 2005 MGRS) between enrollment and 18 months of age (Primarily 12 months after enrollment (age 18 months), secondarily 36 months after enrollment (age 42 months)); Incidence of serious adverse events during the study period (12 months after enrollment (age 18 months))
B: Birth weight (approx 20 weeks after enrollment (within 48 hours)); Newborn length (At 1 week of age); Length for age Z-score (LAZ) at 18 months of age (12 months after enrollment (age 18 months))
C: Infant length at 18 months (18 months of age. Protocol and Statistical Analysis Plan are available at https://osf.io/w93hy.); Infant hemoglobin at 18 months (18 months)
D: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence (Measured 12 and 24 months after intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Research Plan for a Randomised, Single-blind, Parallel Group Controlled Trial in Rural Malawi, Testing the Health Effects of Supplementing Maternal Diet During Pregnancy and Lactation and Infant Diet From 6 to 18 Months of Age With High-energy, Micronutrient Fortified Lipid-based Nutrient Supplements (LNS)
Brief Summary: The use of lipid-based nutrients (LNS), such as Nutributter or fortified spread (FS), have been associated with improved growth and development outcomes among infants in Ghana and Malawi. Modified versions of such supplements have been developed to improve their nutrient density and quality and to lower their costs. Such modified products have proven acceptable to pregnant women in Malawi and Ghana. In the present trial, the investigators aim to test the effect of LNS on pregnancy and child outcomes, when given during pregnant and lactating women and their infants from 6 to 18 months of age. In control groups, participants will receive either iron+folate tables during pregnancy only or multiple micronutrient tablets during pregnancy and first six months of lactations. The main hypothesis to be tested suggests that the mean length-for-age Z-score (LAZ) of 18-month-old infants who received LNS between 6 and 18 months of age and whose mothers were provided with LNS during pregnancy and the first 6 months of lactation is higher than the mean LAZ score of same age infants who received no dietary supplements and whose mothers received iron-folate supplementation during pregnancy only.

To detect the long-term effect of the LNS supplementation, we now propose to conduct a follow-up study when the children are 9 years old, to see if the intervention had effect on children's growth, cardiometabolic and respiratory status and neurocognitive development.


Options:
A: 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)
B: N/A
C: Birth weight (approx 20 weeks after enrollment (within 48 hours)); Newborn length (At 1 week of age); Length for age Z-score (LAZ) at 18 months of age (12 months after enrollment (age 18 months))
D: Maternal primary outcome is child length at birth (0 - 48 hr after birth); Child primary outcome is child length-for-age Z-score (LAZ, based on WHO 2006 growth standards) at 18 months of age (18 months after birth)

Answer: C