TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Lunch in the Bag: Packing More Fruit, Vegetables, Grain in Preschool Sack Lunches
Brief Summary: Lunch is in the Bag is an intervention designed to increase fruits, vegetables, and whole grains in sack lunches prepared for preschool children. Lunch is in the Bag includes 5 weeks of parent handouts, classroom activities related to topics in the handouts, parent and child activities to reinforce behavioral constructs, and a one week booster 22 weeks later.

The primary study hypothesis is that Lunch is in the Bag will increase fruit, vegetables, and whole grains in sack lunches. Additional hypotheses are that lunches at child care centers where the program is used will have higher dietary quality than centers without the program and that children at the centers where the program is used will have a smaller increase in body mass index than children at centers with the program.

The study will also look at the child's home environment and the childcare center. Hypotheses for this research question include

1. Children at centers with Lunch is in the Bag will have greater frequency of eating fruits, vegetables, and whole grains at home than those at centers without the program.
2. Compared to parents at centers without the program, parents of children at centers with Lunch is in the Bag will have

   1. Greater knowledge, expected benefits, support, intentions, and belief in their ability for packing fruit, vegetables, and whole grain in their child's sack lunch daily.
   2. Availability of fruit, vegetable, and whole grain in the home pantry.
   3. Number of lunches with temperature in the safe range at time of service.


Options:
A: Intake of nutrients; Serum lipid and lipoprotein concentrations; Growth and development; Smoking; Physical activity level and fitness; Intima-media thickness of arteries and rate of NO-induced vasodilatation
B: Physical Activity Level (The intervention spans a period of 6 months. Outcomes are measured before and after intervention.); Physical Literacy (The intervention spans a period of 6 months. Outcomes are measured before and after intervention.); Dietary Intake (The intervention spans a period of 6 months. Outcomes are measured before and after intervention.)
C: Body Mass Index score(BMI sds) at the age 6 years to monitor the effectiveness of the intervention (5 years)
D: Change in fruit, vegetable, whole grain in the lunch sack from baseline to 6 weeks, 22 weeks, and 28 weeks (Baseline, 6 weeks, 22 weeks, 28 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Lunch in the Bag: Packing More Fruit, Vegetables, Grain in Preschool Sack Lunches
Brief Summary: Lunch is in the Bag is an intervention designed to increase fruits, vegetables, and whole grains in sack lunches prepared for preschool children. Lunch is in the Bag includes 5 weeks of parent handouts, classroom activities related to topics in the handouts, parent and child activities to reinforce behavioral constructs, and a one week booster 22 weeks later.

The primary study hypothesis is that Lunch is in the Bag will increase fruit, vegetables, and whole grains in sack lunches. Additional hypotheses are that lunches at child care centers where the program is used will have higher dietary quality than centers without the program and that children at the centers where the program is used will have a smaller increase in body mass index than children at centers with the program.

The study will also look at the child's home environment and the childcare center. Hypotheses for this research question include

1. Children at centers with Lunch is in the Bag will have greater frequency of eating fruits, vegetables, and whole grains at home than those at centers without the program.
2. Compared to parents at centers without the program, parents of children at centers with Lunch is in the Bag will have

   1. Greater knowledge, expected benefits, support, intentions, and belief in their ability for packing fruit, vegetables, and whole grain in their child's sack lunch daily.
   2. Availability of fruit, vegetable, and whole grain in the home pantry.
   3. Number of lunches with temperature in the safe range at time of service.


Options:
A: Change in fruit, vegetable, whole grain in the lunch sack from baseline to 6 weeks, 22 weeks, and 28 weeks (Baseline, 6 weeks, 22 weeks, 28 weeks)
B: Physical Activity Level (The intervention spans a period of 6 months. Outcomes are measured before and after intervention.); Physical Literacy (The intervention spans a period of 6 months. Outcomes are measured before and after intervention.); Dietary Intake (The intervention spans a period of 6 months. Outcomes are measured before and after intervention.)
C: Vegetable Flavor Acceptance [Infants' Intake] (6- to 10-month-old weaned infants (3 separate test days )); Taste Liking Ratings of Vegetable Flavors [Mothers]. (Monthly, 0.5 to 4.5 months); Vegetable Flavor Acceptance (Infants' Rate of Feeding) (6- to 10-month-old weaned infants (3 separate test days))
D: Mean Nutrition Environment Score (Measures collected 3-12 weeks prior to start of intervention (Baseline) and 1-8 weeks post-12-month intervention (Follow-up)); Mean Physical Activity Environment Score (Measures collected 3-12 weeks prior to start of intervention (Baseline) and 1-8 weeks post-12-month intervention (Follow-up))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Lunch in the Bag: Packing More Fruit, Vegetables, Grain in Preschool Sack Lunches
Brief Summary: Lunch is in the Bag is an intervention designed to increase fruits, vegetables, and whole grains in sack lunches prepared for preschool children. Lunch is in the Bag includes 5 weeks of parent handouts, classroom activities related to topics in the handouts, parent and child activities to reinforce behavioral constructs, and a one week booster 22 weeks later.

The primary study hypothesis is that Lunch is in the Bag will increase fruit, vegetables, and whole grains in sack lunches. Additional hypotheses are that lunches at child care centers where the program is used will have higher dietary quality than centers without the program and that children at the centers where the program is used will have a smaller increase in body mass index than children at centers with the program.

The study will also look at the child's home environment and the childcare center. Hypotheses for this research question include

1. Children at centers with Lunch is in the Bag will have greater frequency of eating fruits, vegetables, and whole grains at home than those at centers without the program.
2. Compared to parents at centers without the program, parents of children at centers with Lunch is in the Bag will have

   1. Greater knowledge, expected benefits, support, intentions, and belief in their ability for packing fruit, vegetables, and whole grain in their child's sack lunch daily.
   2. Availability of fruit, vegetable, and whole grain in the home pantry.
   3. Number of lunches with temperature in the safe range at time of service.


Options:
A: Body fat (At the end of the intervention and at a six month follow-up)
B: Change in Child Body Mass Index (BMI Z-score) (Change from Baseline at 12 and 21 months)
C: Change in fruit, vegetable, whole grain in the lunch sack from baseline to 6 weeks, 22 weeks, and 28 weeks (Baseline, 6 weeks, 22 weeks, 28 weeks)
D: Number of parents engaging with the HENRY programme measured using Centre level process data (12 month post randomisation (allowing 3 months for Optimisation intervention implementation and collecting data from 1- 2 HENRY courses per site).)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Lunch in the Bag: Packing More Fruit, Vegetables, Grain in Preschool Sack Lunches
Brief Summary: Lunch is in the Bag is an intervention designed to increase fruits, vegetables, and whole grains in sack lunches prepared for preschool children. Lunch is in the Bag includes 5 weeks of parent handouts, classroom activities related to topics in the handouts, parent and child activities to reinforce behavioral constructs, and a one week booster 22 weeks later.

The primary study hypothesis is that Lunch is in the Bag will increase fruit, vegetables, and whole grains in sack lunches. Additional hypotheses are that lunches at child care centers where the program is used will have higher dietary quality than centers without the program and that children at the centers where the program is used will have a smaller increase in body mass index than children at centers with the program.

The study will also look at the child's home environment and the childcare center. Hypotheses for this research question include

1. Children at centers with Lunch is in the Bag will have greater frequency of eating fruits, vegetables, and whole grains at home than those at centers without the program.
2. Compared to parents at centers without the program, parents of children at centers with Lunch is in the Bag will have

   1. Greater knowledge, expected benefits, support, intentions, and belief in their ability for packing fruit, vegetables, and whole grain in their child's sack lunch daily.
   2. Availability of fruit, vegetable, and whole grain in the home pantry.
   3. Number of lunches with temperature in the safe range at time of service.


Options:
A: Maintenance of a Child's Body Mass Index as a result of the intervention (up to two years)
B: Stunting in Children at 18 mo (18 months of age)
C: Change in fruit, vegetable, whole grain in the lunch sack from baseline to 6 weeks, 22 weeks, and 28 weeks (Baseline, 6 weeks, 22 weeks, 28 weeks)
D: Change in BMIz (Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of 2% Lidocaine Gel for IUD Insertion
Brief Summary: The intrauterine device (IUD) is a long-acting, highly effective, reversible contraceptive that may be underutilized due to fear of pain during insertion. Although providers frequently prescribe non-steroidal anti-inflammatory drugs (NSAIDs) for IUD insertion, there is no evidence for any pain reduction. In fact, no interventions evaluated in randomized controlled trials have been shown to be effective in reducing pain during IUD insertion. While many women tolerate IUD insertion well, others have moderate to severe pain. This double-blind randomized controlled trial of 150 women aims to estimate the efficacy of intracervical 2% lidocaine gel compared to placebo (KY jelly) to reduce IUD insertion pain. Our hypothesis is that women who are treated with 2% lidocaine gel prior to IUD insertion will have reduced pain as measured on a 0 mm to 100 mm Visual Analog Scale (VAS). We will be able to detect a 15 mm difference on the VAS with our sample size. Other data to be collected include information regarding age, BMI, obstetric history, lactation status, time since pregnancy or delivery, last menstrual period, history of cervical conization, anxiety levels, anticipated pain levels, insertion characteristics (time, difficulty, complications), side effects, and satisfaction with pain control. If 2% lidocaine gel is effective, then a viable, easily administered option for pain control will be available to providers and patients.


Options:
A: The primary outcome measure is worst perceived pain during the IUD insertion procedure, on a 100 mm visual analogue scale (after IUD insertion)
B: Provider Perceived Ease of Insertion on a 100 Point Visual Analogue Scale (assessed immediately post IUD insertion)
C: Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale (VAS) (Immediately post IUD insertion)
D: Mean Pain Score During IUD Insertion (Day 1)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Randomized, Double-blind, Dose-ranging, Placebo-controlled Study to Evaluate the Efficacy, Response Duration and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria Who Remain Symptomatic Despite Antihistamine Treatment (H1)
Brief Summary: The study is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged 12-75 who have been diagnosed with refractory CIU and who remain symptomatic despite standard-dosed H1 antihistamine treatment.


Options:
A: Reduction in size of existing spontaneous urticaria lesions (wheal and flare) as assessed by thermography. (5 hours)
B: Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR) (Baseline, 14 days); Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval (Baseline, 14 days); Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval (Baseline, 14 days); Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration (Baseline, 14 days); Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval (Baseline, 14 days); Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) (Baseline, 14 days); Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 3 (Day 7) (7 days); Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) (14 days)
C: Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR) (Baseline, 14 days); Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval (Baseline, 14 days); Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval (Baseline, 14 days); Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration (Baseline, 14 days); Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval (Baseline, 14 days); Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) (Baseline, 14 days); Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 3 (Day 7) (7 days); Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) (14 days)
D: Change From Baseline in the Weekly Itch Severity Score at Week 12 (Baseline, Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Adapted Cognitive/Affective Remediation for Cannabis Misuse in Schizophrenia
Brief Summary: This study will integrate and adapt a cognitive remediation (Cognitive Enhancement Therapy \[CET\]) and an affect regulation (Personal Therapy \[PT\]) intervention for 50 individuals with schizophrenia that misuse cannabis. Participants will be randomized to CET/PT plus treatment as usual (TAU) or TAU alone and treated for 18 months.


Options:
A: Health of Nations Outcome Scale (HONOS) (Baseline, 6 months, 12 months, 18 months,)
B: longest continuous period of cocaine abstinence (Week 8)
C: Cognitive/Affective Functional Outcomes (Baseline, 6-month, 12-month and 18 month)
D: Stimulant drug use as measured by urine analysis (Treatment phase: 12 weeks (3 measurements a week), Follow Up Phase: 3 months (1 measuresment a month))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Acute Inhalation of Hypertonic Saline Does Not Improve Mucociliary Clearance in All Children With Cystic Fibrosis
Brief Summary: Previously, the investigators and others have shown that mucociliary clearance (MCC) is defective in patients with cystic fibrosis (CF) and it is now thought that alterations in airway mucus rheology figure prominently in the impairment. Mucociliary clearance works by trapping toxic particles, bacteria and viruses in the lung mucus and then quickly removing the mucus out of the lungs. Defects in MCC typically lead to the accumulation of mucus in the airways, and this in turn is associated with acute infections, chronic bacterial colonization and chronic inflammation. One treatment strategy that is gaining acceptance as an important therapy for improving MCC in adults with CF is the inhalation of the osmotic stimulus, hypertonic saline (HS). A number of studies have shown that acute inhalation of HS (7% saline) significantly improves MCC in adults with CF and results from a recent study indicate that two weeks of inhaling HS leads to a significant increase in MCC that is sustained for 8 hours post inhalation and is associated with significant improvements in FEV1, FVC and FEF25-75 values. Since MCC in patients with CF appears to be impaired by adulthood, any drug that disrupts or slows the impairment in childhood could prove enormously beneficial in the long-term prognosis of the disease. Nevertheless, no studies have been conducted to determine if HS treatment improves MCC in children with CF. This is most problematic for physicians who care for children with CF who have normal FEV1 and FVC values, since it is unclear if they should treat these children with HS or not. This research study is designed to begin to answer this question. The investigators hypothesize that acute inhalation of hypertonic saline (7%) will improve MCC in CF children with normal pulmonary function. Our hypothesis will be tested in a one-year clinical trial that will be randomized and placebo-controlled. Twelve children with CF who are 7-12 years old and have normal FEV1 and FVC values will participate. Our goal will be to compare MCC in these children on two study visits after acute inhalations of placebo (0.12% saline) or hypertonic saline (HS) (7% saline) aerosol. The investigators predict that MCC values after acute inhalation of 7% HS aerosol will be statistically significantly greater than after placebo inhalation.


Options:
A: The rate of protocol-defined pulmonary exacerbations requiring treatment with oral, inhaled or intravenous antibiotics between subjects randomized to HS and IS (during the 48 week treatment period)
B: Percent Mucociliary Clearance at 60 Minutes (60 minutes)
C: Change in LCI from baseline to end of treatment in hypertonic saline treated patients versus patients receiving placebo (isotonic saline) (Duration of patient's involvement in study)
D: Change in Mucociliary Clearance Rate (Baseline versus after completion of 4 week treatment period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Acute Inhalation of Hypertonic Saline Does Not Improve Mucociliary Clearance in All Children With Cystic Fibrosis
Brief Summary: Previously, the investigators and others have shown that mucociliary clearance (MCC) is defective in patients with cystic fibrosis (CF) and it is now thought that alterations in airway mucus rheology figure prominently in the impairment. Mucociliary clearance works by trapping toxic particles, bacteria and viruses in the lung mucus and then quickly removing the mucus out of the lungs. Defects in MCC typically lead to the accumulation of mucus in the airways, and this in turn is associated with acute infections, chronic bacterial colonization and chronic inflammation. One treatment strategy that is gaining acceptance as an important therapy for improving MCC in adults with CF is the inhalation of the osmotic stimulus, hypertonic saline (HS). A number of studies have shown that acute inhalation of HS (7% saline) significantly improves MCC in adults with CF and results from a recent study indicate that two weeks of inhaling HS leads to a significant increase in MCC that is sustained for 8 hours post inhalation and is associated with significant improvements in FEV1, FVC and FEF25-75 values. Since MCC in patients with CF appears to be impaired by adulthood, any drug that disrupts or slows the impairment in childhood could prove enormously beneficial in the long-term prognosis of the disease. Nevertheless, no studies have been conducted to determine if HS treatment improves MCC in children with CF. This is most problematic for physicians who care for children with CF who have normal FEV1 and FVC values, since it is unclear if they should treat these children with HS or not. This research study is designed to begin to answer this question. The investigators hypothesize that acute inhalation of hypertonic saline (7%) will improve MCC in CF children with normal pulmonary function. Our hypothesis will be tested in a one-year clinical trial that will be randomized and placebo-controlled. Twelve children with CF who are 7-12 years old and have normal FEV1 and FVC values will participate. Our goal will be to compare MCC in these children on two study visits after acute inhalations of placebo (0.12% saline) or hypertonic saline (HS) (7% saline) aerosol. The investigators predict that MCC values after acute inhalation of 7% HS aerosol will be statistically significantly greater than after placebo inhalation.


Options:
A: Percent Mucociliary Clearance at 60 Minutes (60 minutes)
B: Lung function (FEV1, FVC, FEF25-75)
C: Change in FEV1 (in liters) from baseline (At the end of the 14 day treatment period); Adverse events such as gastrointestinal complaints, wheezing, hepatitis or shortness of breath (70 weeks)
D: Wet sputum production (45 minutes)

Answer: A