TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunizing Infants Against Pain: a Hospital-based Postnatal Parent Education Intervention About Infant Immunizations
Brief Summary: Immunization injections are the most common recurring painful medical procedure undertaken in childhood. Numerous evidence-based and feasible interventions are available to mitigate immunization pain, however, there is low uptake of these interventions in clinical practice, revealing a knowledge-to-care gap between what is known about pain and pain management. This is a 4-year single-centre, randomized, parallel 3-group add-on trial that will enrol 3420 mothers hospitalized following the birth of an infant at Mount Sinai Hospital (MSH) in Toronto. The trial will evaluate and compare the impact of two levels of intensity of maternal education about pain management during infant immunizations ('low': pamphlet vs. 'high': pamphlet + video) compared to placebo control after the birth of an infant on maternal behaviour during future infant immunizations at up to 6 months of age (use of analgesic interventions), maternal knowledge and attitudes about pain and pain management up to 6 months after birth.


Options:
A: Analgesic utilization (Up to 6 months)
B: The primary outcome: Feasibility and acceptability of study procedure (after the study completion (4 months after the baseline survey))
C: recovery after inguinal hernia surgery = time to restore normal activities after surgery (one week)
D: Hypersensitivity to pain (At 15 month vaccination (Visit 5))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Citalopram Treatment in Acute Stroke
Brief Summary: We wish to conduct a prospective, randomized, double blind, placebo controlled multi center study of the combined neuroprotective and antithrombotic effects of SSRI treatment after stroke.

Hypotheses:

SSRI treatment commenced in the acute phase of stroke (day 0-7) protects against new thromboembolic events and leads to better rehabilitation. 600 stroke patients will be randomized in a 1:1 ratio.

The treatment and follow up period is 6 months. During these 6 months there will be 2 clinical follow up visits, one telephone control and one visit to evaluate compliance regarding medication.


Options:
A: Incidence of depressive disorders in the study population (Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18)
B: Peak treadmill speed (4 weeks)
C: Vascular death, Transient Ischemic Attack (TIA)/stroke and myocardial infarction (combined) (6 months); Functional status at 6-months (6 months)
D: Changes in Motor Function (Jebsen-Taylor Task) (baseline and 90 days); Changes in Fugl-Meyer Assessment (FMA) Scale (baseline and 90 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Citalopram Treatment in Acute Stroke
Brief Summary: We wish to conduct a prospective, randomized, double blind, placebo controlled multi center study of the combined neuroprotective and antithrombotic effects of SSRI treatment after stroke.

Hypotheses:

SSRI treatment commenced in the acute phase of stroke (day 0-7) protects against new thromboembolic events and leads to better rehabilitation. 600 stroke patients will be randomized in a 1:1 ratio.

The treatment and follow up period is 6 months. During these 6 months there will be 2 clinical follow up visits, one telephone control and one visit to evaluate compliance regarding medication.


Options:
A: Peak treadmill speed (4 weeks)
B: Vascular death, Transient Ischemic Attack (TIA)/stroke and myocardial infarction (combined) (6 months); Functional status at 6-months (6 months)
C: Progression in the Fugl-Meyer Motor Scale (M3 (3 months))
D: Fugl Meyer Motor Scale score (Baseline and 90 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Airway Infection, Inflammatory Markers and Exercise Capacity in Patients With Cystic Fibrosis and at Least One G551D Mutation Taking VX770 (Ivacaftor)
Brief Summary: Ivacaftor will restore CFTR function in treated CF patients with the G551D mutation. Improvement in ventilation, salt balance and well-being will contribute to better exercise capacity at all levels of lung function. While potential improvements may be variable across the spectrum of lung function, even small gains at low levels of FEV1 may have significant benefit for some subjects.


Options:
A: Change From Baseline in Total Chloride Transport at Day 14 of Cycles 1 and 2 (Baseline of Cycle 1 and Cycle 2, Day 14 of Cycle 1 and Cycle 2 (1 cycle=28 days)); Number of Participants With a Chloride Transport Response at Day 14 of Cycles 1 and 2 (Day 14 of Cycle 1 and Cycle 2 (1 cycle=28 days)); Number of Participants With Normalization of Chloride Transport Between Baseline and Day 14 of Cycles 1 and 2 (Overall Baseline and Day 14 of Cycle 1 and Cycle 2 (1 cycle=28 days))
B: Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs) (Study 105: Day 1 up to Week 168)
C: exercise capacity (one month, 3 months)
D: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 24 (Baseline, Week 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Pantheris Optical Coherence Tomography Imaging Atherectomy System for Use in the Peripheral Vasculature
Brief Summary: A non-randomized, prospective, global clinical trial of the Avinger Pantheris System, an atherectomy device that provides directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque in diseased lower extremity arteries.


Options:
A: Freedom From Target Lesion Revascularization (TLR) (6 months); Freedom From Major Adverse Events (MAE) (30 days)
B: Event-free Survival Rate (12 months); Primary Patency (12 months)
C: The primary endpoint will be primary patency of the treated site at 6 months. Primary patency is defined as <50% loss of luminal diameter at the treated site on CT arteriography (CTA) without re-intervention in the interim. (6 months)
D: Primary Safety Endpoint (Day 0 through 6 Months); Primary Effectiveness Endpoint: Technical Success (Day 0)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Longitudinal Study to Assess if the Effectiveness of a Preschool Nutrition and Physical Activity Program is Sustained in Elementary School
Brief Summary: The Colorado Longitudinal Eating And Physical activity (LEAP) Study utilizes a social ecological approach to explore individual, family and environmental factors and their relationship to child weight status over a 3 year timeframe. Our primary research questions are as follows:

1. Are behavior changes (increased willingness to try new foods and gross motor skills) from a preschool nutrition and activity program, The Food Friends®, sustained through early elementary school?
2. Do The Food Friends® programs have an impact on reducing the percentage of children considered overweight and/or obese over a 3 year timeframe?
3. Do food preference and gross motor performance directly affect child weight status or are they mediators to dietary intake and physical activity?


Options:
A: Absolute change in mean accelerometry counts over 6 days (baseline, end of intervention, six months after end of intervention)
B: BMI z score (24 months (end of intervention)); BMI z score (60 months of age (followup at 5 years of age)); BMI z score (Follow-up at 11 years of age)
C: Body mass index (BMI) >= 85th percentile, adjusted for gender and age (baseline, end of 7th grade, end of study); Fasting glucose (mg/dL) (baseline, end of study); Fasting insulin (mU/mL) (baseline, end of study)
D: Change in Weight Status (baseline and 2 year follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Longitudinal Study to Assess if the Effectiveness of a Preschool Nutrition and Physical Activity Program is Sustained in Elementary School
Brief Summary: The Colorado Longitudinal Eating And Physical activity (LEAP) Study utilizes a social ecological approach to explore individual, family and environmental factors and their relationship to child weight status over a 3 year timeframe. Our primary research questions are as follows:

1. Are behavior changes (increased willingness to try new foods and gross motor skills) from a preschool nutrition and activity program, The Food Friends®, sustained through early elementary school?
2. Do The Food Friends® programs have an impact on reducing the percentage of children considered overweight and/or obese over a 3 year timeframe?
3. Do food preference and gross motor performance directly affect child weight status or are they mediators to dietary intake and physical activity?


Options:
A: Change in Nutrition and Physical Activity Policies (Baseline, Year 1, Year 2)
B: Change in Prevalence of Overweight and Obesity Using Body Mass Index Percentile for Age and Sex (Baseline, 24 months); Change in Waist Circumference (Baseline, 78 months); Prevalence of Acanthosis Nigricans (Baseline, 24 months); Change in Prevalence of Overweight and Obesity Using Body Mass Index Percentile for Age and Sex (Baseline, 78 months); Change in Waist Circumference (Baseline, 24 months); Prevalence of Acanthosis Nigricans (Baseline, 78 months)
C: To evaluate and compare in overweight children the effectiveness of the following interventions: a parent-centered dietary modification program; a physical activity skill development program; and a parent-centered dietary modification + physical activity skill development program.
D: Change in Weight Status (baseline and 2 year follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Primary Delivery of the Anterior Compared With the Posterior Shoulder on Perineal Trauma: a Randomized Controlled Trial
Brief Summary: It is unknown if primary delivery of the anterior or the posterior shoulder causes less perineal tear. The objective of this trial is to evaluate the incidence and degree of perineal trauma after primary delivery of the anterior shoulder compared to primary delivery of the posterior shoulder during vaginal birth in primiparous women in a randomized controlled trial. The hypothesis is that primary delivery of the posterior shoulder reduces the rate and degree of perineal trauma.


Options:
A: Perineal rupture grade III-IV (anal sphincter tears) (At delivery - within minutes - hours of randomization)
B: Episiotomy procedures (until completed the second stage of labour, about from 30 min to 24 h)
C: Grade I and II rupture during delivery (time at the delivery department (up to 12 months))
D: Number of patients with perineal tears (perineal tears are evaluated within 1 hour of delivery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Primary Delivery of the Anterior Compared With the Posterior Shoulder on Perineal Trauma: a Randomized Controlled Trial
Brief Summary: It is unknown if primary delivery of the anterior or the posterior shoulder causes less perineal tear. The objective of this trial is to evaluate the incidence and degree of perineal trauma after primary delivery of the anterior shoulder compared to primary delivery of the posterior shoulder during vaginal birth in primiparous women in a randomized controlled trial. The hypothesis is that primary delivery of the posterior shoulder reduces the rate and degree of perineal trauma.


Options:
A: PERINEAL LACERATION Primary outcome: 1. Perineal laceration - present or absent (1 hour postpartum)
B: Grade I and II rupture during delivery (time at the delivery department (up to 12 months))
C: Number of patients with perineal tears (perineal tears are evaluated within 1 hour of delivery)
D: Number of women with obstetric anal sphincter injury (4 hour)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Mothers and Others: Family-based Obesity Prevention for Infants and Toddlers
Brief Summary: The purpose of this study is to conduct a randomized controlled trial among 468 Non-Hispanic black mothers and their families to test the efficacy of MOTHERS AND OTHERS, a multi-component home visitation program, compared to an attention control (child safety) in promoting appropriate weight gain during infancy.


Options:
A: Number of Participants Breastfeeding Without Formula Supplementation (Postpartum day number 2)
B: Mean weight-for-length z-score at 15 months of age (15 months of age)
C: Pain Sensitivity (Baseline); Genetic variations in COMT (Baseline)
D: Karitane parenting confidence scale, KPCS. Change is being assessed. (measured at 2 weeks, 3 and 9 months post partum); Infant Care Index (measured 4 months post partum); Ages & States questionnarie, ASQ-SE. Change is being assessed. (measured at 2 weeks, 3 and 9 months post partum)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Mothers and Others: Family-based Obesity Prevention for Infants and Toddlers
Brief Summary: The purpose of this study is to conduct a randomized controlled trial among 468 Non-Hispanic black mothers and their families to test the efficacy of MOTHERS AND OTHERS, a multi-component home visitation program, compared to an attention control (child safety) in promoting appropriate weight gain during infancy.


Options:
A: Mean weight-for-length z-score at 15 months of age (15 months of age)
B: Linear Growth (6-18 mos of age)
C: Nutritional status (baseline (before intervention), endline (6 months after intervention), and follow up (2 years after endline)); Child development (baseline (before intervention), endline (6 months after intervention), and follow up (2 years after endline))
D: Exclusive breastfeeding among children aged 0-5.9 months in the intervention areas only (2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017); Minimum dietary diversity among children aged 6-23.9 months (2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017); Minimum meal frequency of (semi) solid or soft foods among children aged 6-23.9 months (2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Preterm Infants' Paracetamol Study
Brief Summary: Present randomized, controlled, double-blind trial investigates the efficacy and safety of early (\<24 h) intravenous paracetamol therapy for pain medication in very small premature infants. This phase 2 drug study focuses on the efficacy and safety of short-term use. The pharmacokinetics and pharmacodynamics of paracetamol, as well as the long-term effects, are studied.

This study recruits preterm infants born less than 32 weeks gestational age and treated at the neonatal intensive care unit of Oulu University Hospital. The informed consent is asked from all parents. The first drug dose is given before 24 hours of age. Masked study drug is paracetamol infusion solution 10 mg/mL or placebo, 0.45% saline solution. The loading dose is 20 mg/kg, and the maintenance dose 7.5 mg/kg every 6 hours for 4 days. The exact date of the closure of ductus is studied by repeated echocardiographic examinations. The symptoms of pain are screened by a pain scale of preterm infants (NIAPAS). Patients are monitored for signs of possible side effects. After discharge from hospital, patients are examined at follow-up clinic for the first year every 3 months and at 2 years of age.


Options:
A: Number of Infants Who Undergo in Hospital PDA Ligations or Who Have an Open Ductus at the Time of Discharge (That Need Future Outpatient Cardiology Follow-up Visits) (through hospital discharge (approximately 6 months unless death occurs first))
B: Days Spent on Supplemental Oxygen During the First 28 Days. (28 days of life)
C: Ductus diameter mm/kg (at postnatal age of 5 days); Cumulative dosage of morphine (at postnatal age of 5 days)
D: 2-year survival without cerebral palsy (2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Preterm Infants' Paracetamol Study
Brief Summary: Present randomized, controlled, double-blind trial investigates the efficacy and safety of early (\<24 h) intravenous paracetamol therapy for pain medication in very small premature infants. This phase 2 drug study focuses on the efficacy and safety of short-term use. The pharmacokinetics and pharmacodynamics of paracetamol, as well as the long-term effects, are studied.

This study recruits preterm infants born less than 32 weeks gestational age and treated at the neonatal intensive care unit of Oulu University Hospital. The informed consent is asked from all parents. The first drug dose is given before 24 hours of age. Masked study drug is paracetamol infusion solution 10 mg/mL or placebo, 0.45% saline solution. The loading dose is 20 mg/kg, and the maintenance dose 7.5 mg/kg every 6 hours for 4 days. The exact date of the closure of ductus is studied by repeated echocardiographic examinations. The symptoms of pain are screened by a pain scale of preterm infants (NIAPAS). Patients are monitored for signs of possible side effects. After discharge from hospital, patients are examined at follow-up clinic for the first year every 3 months and at 2 years of age.


Options:
A: Ductus diameter mm/kg (at postnatal age of 5 days); Cumulative dosage of morphine (at postnatal age of 5 days)
B: 2-year survival without cerebral palsy (2 years)
C: closure of PDA (6 days)
D: dichotomous variable: survival without BPD at 36 weeks PMA. (add 8 to12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Preterm Infants' Paracetamol Study
Brief Summary: Present randomized, controlled, double-blind trial investigates the efficacy and safety of early (\<24 h) intravenous paracetamol therapy for pain medication in very small premature infants. This phase 2 drug study focuses on the efficacy and safety of short-term use. The pharmacokinetics and pharmacodynamics of paracetamol, as well as the long-term effects, are studied.

This study recruits preterm infants born less than 32 weeks gestational age and treated at the neonatal intensive care unit of Oulu University Hospital. The informed consent is asked from all parents. The first drug dose is given before 24 hours of age. Masked study drug is paracetamol infusion solution 10 mg/mL or placebo, 0.45% saline solution. The loading dose is 20 mg/kg, and the maintenance dose 7.5 mg/kg every 6 hours for 4 days. The exact date of the closure of ductus is studied by repeated echocardiographic examinations. The symptoms of pain are screened by a pain scale of preterm infants (NIAPAS). Patients are monitored for signs of possible side effects. After discharge from hospital, patients are examined at follow-up clinic for the first year every 3 months and at 2 years of age.


Options:
A: Cerebral tissue oxygen saturation during first 72 hours of life (during first 72 hours of life)
B: closure of PDA (6 days)
C: Efficacy and Safety of Oral Paracetamol Versus Oral Ibuprofen (Until discharge)
D: Ductus diameter mm/kg (at postnatal age of 5 days); Cumulative dosage of morphine (at postnatal age of 5 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin Administered in Subjects Infected With Chronic HCV Who Have Advanced Liver Disease or Are Post-Liver Transplant
Brief Summary: This study will evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) in participants with advanced liver disease or posttransplant and chronic genotype 1 or 4 hepatitis C virus (HCV) infection.

* Cohort A: decompensated cirrhosis (advanced liver disease), no prior liver transplant;
* Cohort B: post-liver transplant, with or without cirrhosis;
* Group assignment within cohorts is based on severity of liver impairment at screening (Child-Pugh-Turcotte (CPT) score for participants with cirrhosis; fibrosis; or presence of disease for fibrosing cholestatic hepatitis (FCH) groups)
* Randomization is 1:1 within groups to 12 or 24 weeks of LDV/SOF+RBV treatment.


Options:
A: PIVKA-II (Day one)
B: Efficacy of screening measure to detect very early/early stage HCC (Barcelona Clinic Liver Cancer Staging System) (6-12 months)
C: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Up to 24 weeks)
D: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Depression/Hypertension in Chinese Older Adults-Collaboration in Health
Brief Summary: This study will see if education of village doctors and aging workers in identification and management of hypertension and depression, using standardized procedures,consultation with a psychiatrist as needed, and collaborations between the village doctor and aging worker in care elderly patients in the village better achieve better outcomes for their depression and high blood pressure than usual care.


Options:
A: Severity of Trauma. This will be the difference in group mean score of severity of depression based on a sum of ratings of various standard depression symptoms from the Hopkins Symptom Checklist and locally defined symptoms. (After 12 counseling , 4-5 months)
B: Depressive symptom change (baseline, 3-, 6-, and 12-month follow up)
C: Hopkins Symptom Checklist-25 (HSCL-25) (Change from baseline assessment, at 1 week post-intervention assessment (6 weeks after baseline), change from post-assessment at 3 month post-intervention assessment (4-4.5 months after baseline), and change from at 12 month post intervention assessment)
D: Change of depression symptom from baseline at 3 and 6 months (0-3-6 months); Change of anxiety symptom from baseline at 3 and 6 months (0-3-6 months); Change of chronic pain symptom from baseline at 3 and 6 months (0-3-6 months); Change of anger from baseline at 3 and 6 months (0-3-6 months); Change of PTSD symptom from baseline at 3 and 6 months (0-3-6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of an Aquatic Physical Exercise Program on Glycemic Control and Perinatal Outcomes of Gestational Diabetes - a Randomized Clinical Trial
Brief Summary: The purpose of this study is to verify the efficacy of an aquatic physical exercise program on GDM control and adverse maternal and fetal outcomes.


Options:
A: Gestational diabetes diagnosis assessed through glucose tolerance test. (28 weeks gestational age)
B: Glycemic control (one year)
C: Serum fasting glucose values. (Fasting glucose will be measured at recruitment (24 weeks of gestation) and at the end of follow-up (38 weeks of gestation))
D: Number of Participants With Composite Neonatal Morbidity (Delivery through discharge of infant from hospital up to 120 days); Number of Children at the 5-10 Year Followup With BMI ≥ 95th Percentile for Age and Sex (Age 5-10 years)

Answer: B