TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Intervention for Risk Factors in Pregnant Women in Washington, D.C. (DC-HOPE)
Brief Summary: The purpose of this study is to determine if an integrated intervention addressing active smoking, environmental tobacco smoke exposure, depression and intimate partner violence, would improve pregnancy outcome among African American women.


Options:
A: Reducing children's exposure to Intimate Partner Violence (Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.); Patterns of Intimate Partner Violence (Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.); Reducing Intimate Partner Violence (Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.)
B: Child cognitive development, behavior, and health (At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years); Child social-emotional development (At-risk sample: Up to 6 years; Not-at risk sample: Up to 1 year); Child depression (At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years)
C: Reduction of risk behaviors:; Active smoking; Environmental Tobacco Smoke Exposure; Depression; Intimate Partner Violence
D: Incident Gender-Based Violence (GBV) (3 months postpartum); Incident GBV (6 months postpartum)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D Dose-Response Study to Establish Dietary Requirements in Infants
Brief Summary: The research team is comprised of an expert nutrition scientist and a pediatrician with expertise in endocrinology. Both have world-class experience in assessing bone mass in infancy. Together they have designed a study to determine how much dietary vitamin D is needed to optimize health in infants. This is important since many infants are born with vitamin D deficiency. At present the dosage of vitamin D that is optimal for infant health is unclear and recent research suggests that vitamin D status very early in life has long lasting effects on bone mass and other health issues. Therefore, in a group of healthy infants, this research team will test which dosage of vitamin D is needed to achieve optimal vitamin D status. Optimal vitamin D status will be based on growth, biomarkers of vitamin D and bone status in blood and also general health. The infants will all be breastfed and begin the study at about 2 weeks of age. At 3 months intervals over the first year of life, each infant will be measured for growth, duration of breastfeeding and supplement use plus have a bone density scan to determine changes in bone growth. The data will be helpful to guide health care professionals in providing the best care possible for their infants. It will also be important to the health of populations since dietary recommendations for vitamin D are used to guide fortification of foods and development of evidence based policy around nutrient recommendations and their implementation.


Options:
A: Vitamin D plasma concentrations (12 months)
B: Body Mass Index score(BMI sds) at the age 6 years to monitor the effectiveness of the intervention (5 years)
C: BMI z-score (via measured weight and height) of preschooler (~2 years post baseline)
D: Group differences in percentage of mothers who meet breastfeeding and complementary feeding recommendations and percentage of mothers who introduce sugar sweetened beverages over time as assessed by the Child Feeding Assessment. (2 weeks - 24 months postpartum); Group differences in mean scores for infant feeding style subscales assessed using the Infant Feeding Behavior Questionnaire. (2 months-12 months postpartum); Group differences in in mean scores for toddler feeding style subscales assessed using the Toddler Feeding Behavior Questionnaire (TFBQ). (24 months postpartum); Group differences in children's fruit and vegetable intake, sugar sweetened beverage (SSB) consumption, snacks, and desserts over time. (6 and 24 months postpartum); Group differences in children's physical activity levels as assessed by accelerometry. (18 months-24 months postpartum); Group differences in children's reported physical activity, screen time and other sedentary activities over time as assessed by the Child Physical Activity Assessment. (2 weeks-24 months postpartum); Group differences in children's mean BMI z-scores over time as assessed through child weight and length measurements over time. (2 weeks-24 months postpartum)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D Dose-Response Study to Establish Dietary Requirements in Infants
Brief Summary: The research team is comprised of an expert nutrition scientist and a pediatrician with expertise in endocrinology. Both have world-class experience in assessing bone mass in infancy. Together they have designed a study to determine how much dietary vitamin D is needed to optimize health in infants. This is important since many infants are born with vitamin D deficiency. At present the dosage of vitamin D that is optimal for infant health is unclear and recent research suggests that vitamin D status very early in life has long lasting effects on bone mass and other health issues. Therefore, in a group of healthy infants, this research team will test which dosage of vitamin D is needed to achieve optimal vitamin D status. Optimal vitamin D status will be based on growth, biomarkers of vitamin D and bone status in blood and also general health. The infants will all be breastfed and begin the study at about 2 weeks of age. At 3 months intervals over the first year of life, each infant will be measured for growth, duration of breastfeeding and supplement use plus have a bone density scan to determine changes in bone growth. The data will be helpful to guide health care professionals in providing the best care possible for their infants. It will also be important to the health of populations since dietary recommendations for vitamin D are used to guide fortification of foods and development of evidence based policy around nutrient recommendations and their implementation.


Options:
A: Serum 25-hydroxyvitamin D in pregnant women and cord blood (Change from 1st through 2nd trimester and at delivery)
B: Number of Infants With Recurrent Wheezing (up to 12 months adjusted age)
C: Equivalency of isoforms (3 months)
D: Vitamin D plasma concentrations (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D Dose-Response Study to Establish Dietary Requirements in Infants
Brief Summary: The research team is comprised of an expert nutrition scientist and a pediatrician with expertise in endocrinology. Both have world-class experience in assessing bone mass in infancy. Together they have designed a study to determine how much dietary vitamin D is needed to optimize health in infants. This is important since many infants are born with vitamin D deficiency. At present the dosage of vitamin D that is optimal for infant health is unclear and recent research suggests that vitamin D status very early in life has long lasting effects on bone mass and other health issues. Therefore, in a group of healthy infants, this research team will test which dosage of vitamin D is needed to achieve optimal vitamin D status. Optimal vitamin D status will be based on growth, biomarkers of vitamin D and bone status in blood and also general health. The infants will all be breastfed and begin the study at about 2 weeks of age. At 3 months intervals over the first year of life, each infant will be measured for growth, duration of breastfeeding and supplement use plus have a bone density scan to determine changes in bone growth. The data will be helpful to guide health care professionals in providing the best care possible for their infants. It will also be important to the health of populations since dietary recommendations for vitamin D are used to guide fortification of foods and development of evidence based policy around nutrient recommendations and their implementation.


Options:
A: Vitamin D plasma concentrations (12 months)
B: Maintenance of a Child's Body Mass Index as a result of the intervention (up to two years)
C: BMI z-score (via measured weight and height) of preschooler (~2 years post baseline)
D: Change in Child Physical Activity (Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.); Change in Child Dietary Intake (Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D Dose-Response Study to Establish Dietary Requirements in Infants
Brief Summary: The research team is comprised of an expert nutrition scientist and a pediatrician with expertise in endocrinology. Both have world-class experience in assessing bone mass in infancy. Together they have designed a study to determine how much dietary vitamin D is needed to optimize health in infants. This is important since many infants are born with vitamin D deficiency. At present the dosage of vitamin D that is optimal for infant health is unclear and recent research suggests that vitamin D status very early in life has long lasting effects on bone mass and other health issues. Therefore, in a group of healthy infants, this research team will test which dosage of vitamin D is needed to achieve optimal vitamin D status. Optimal vitamin D status will be based on growth, biomarkers of vitamin D and bone status in blood and also general health. The infants will all be breastfed and begin the study at about 2 weeks of age. At 3 months intervals over the first year of life, each infant will be measured for growth, duration of breastfeeding and supplement use plus have a bone density scan to determine changes in bone growth. The data will be helpful to guide health care professionals in providing the best care possible for their infants. It will also be important to the health of populations since dietary recommendations for vitamin D are used to guide fortification of foods and development of evidence based policy around nutrient recommendations and their implementation.


Options:
A: Vitamin D plasma concentrations (12 months)
B: Mortality (weekly); Incidence of disease requiring hospitalization; Morbidity and hospitalization (weekly)
C: incidence of pneumonia (18 months)
D: Serum vitamin D levels (6 months); Tuberculin Skin Test conversion (6 monhs)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D Dose-Response Study to Establish Dietary Requirements in Infants
Brief Summary: The research team is comprised of an expert nutrition scientist and a pediatrician with expertise in endocrinology. Both have world-class experience in assessing bone mass in infancy. Together they have designed a study to determine how much dietary vitamin D is needed to optimize health in infants. This is important since many infants are born with vitamin D deficiency. At present the dosage of vitamin D that is optimal for infant health is unclear and recent research suggests that vitamin D status very early in life has long lasting effects on bone mass and other health issues. Therefore, in a group of healthy infants, this research team will test which dosage of vitamin D is needed to achieve optimal vitamin D status. Optimal vitamin D status will be based on growth, biomarkers of vitamin D and bone status in blood and also general health. The infants will all be breastfed and begin the study at about 2 weeks of age. At 3 months intervals over the first year of life, each infant will be measured for growth, duration of breastfeeding and supplement use plus have a bone density scan to determine changes in bone growth. The data will be helpful to guide health care professionals in providing the best care possible for their infants. It will also be important to the health of populations since dietary recommendations for vitamin D are used to guide fortification of foods and development of evidence based policy around nutrient recommendations and their implementation.


Options:
A: Child anthropometry (Baseline. Up to 12 months. Up to 24 months.); Child food intake (Baseline. Up to 12 months. Up to 24 months.); Child health (Baseline. Up to 12 months. Up to 24 months.); Distribution of food intake within the household (Baseline. Up to 12 months. Up to 24 months.); Household food security (Baseline. Up to 12 months. Up to 24 months.); Maternal nutrition knowledge (Baseline. Up to 12 months. Up to 24 months.)
B: Increase physical activity (2010); Increase the intake of fiber (2010); Decrease fat intake (2010); Decrease television and other screen time (2010); Decrease obesity (2010)
C: Body Mass Index score(BMI sds) at the age 6 years to monitor the effectiveness of the intervention (5 years)
D: Vitamin D plasma concentrations (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D Dose-Response Study to Establish Dietary Requirements in Infants
Brief Summary: The research team is comprised of an expert nutrition scientist and a pediatrician with expertise in endocrinology. Both have world-class experience in assessing bone mass in infancy. Together they have designed a study to determine how much dietary vitamin D is needed to optimize health in infants. This is important since many infants are born with vitamin D deficiency. At present the dosage of vitamin D that is optimal for infant health is unclear and recent research suggests that vitamin D status very early in life has long lasting effects on bone mass and other health issues. Therefore, in a group of healthy infants, this research team will test which dosage of vitamin D is needed to achieve optimal vitamin D status. Optimal vitamin D status will be based on growth, biomarkers of vitamin D and bone status in blood and also general health. The infants will all be breastfed and begin the study at about 2 weeks of age. At 3 months intervals over the first year of life, each infant will be measured for growth, duration of breastfeeding and supplement use plus have a bone density scan to determine changes in bone growth. The data will be helpful to guide health care professionals in providing the best care possible for their infants. It will also be important to the health of populations since dietary recommendations for vitamin D are used to guide fortification of foods and development of evidence based policy around nutrient recommendations and their implementation.


Options:
A: Gene Expression (Baseline and Final Visits)
B: To evaluate the effects of supplemental vitamin D in enhancing calcium absorption in healthy children 4 to 8 yrs of age. (End of the study)
C: Vitamin D plasma concentrations (12 months)
D: Change in Serum Hepcidin With Vitamin D Intervention for Children With Chronic Kidney Disease (change from baseline to up to three months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Antibiotic Prophylaxis After Acute Pyelonephritis for Prevention of Urinary Tract Infections in Children With Vesico-Ureteral Reflux.
Brief Summary: The aim of this study is to assess the effectiveness of antibiotic prophylaxis in preventing pyelonephritis and in avoiding the appearance of new scars in a sample of children under 36 months with vesico-ureteral reflux (VUR).


Options:
A: The primary end-point is UTI Recurrence Rate during the 12-month observation period and the Development of renal damage (parenchymal scar) after 12 months.
B: 1. Duration of fever (>38°),; 2. Sterilization of the urine,; 3. Reduction of the blood inflammatory indices,; 4. Incidence of renal scarring documented at 12 month.
C: Recurrent Febrile or Symptomatic Urinary Tract Infection During 2-year Follow-up (2 years)
D: Recurrence of pyelonephritis (up to 4 years after enrollment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Antibiotic Prophylaxis After Acute Pyelonephritis for Prevention of Urinary Tract Infections in Children With Vesico-Ureteral Reflux.
Brief Summary: The aim of this study is to assess the effectiveness of antibiotic prophylaxis in preventing pyelonephritis and in avoiding the appearance of new scars in a sample of children under 36 months with vesico-ureteral reflux (VUR).


Options:
A: Recurrence of pyelonephritis (up to 4 years after enrollment)
B: Recurrent Febrile or Symptomatic Urinary Tract Infection During 2-year Follow-up (2 years)
C: 1. Duration of fever (>38°),; 2. Sterilization of the urine,; 3. Reduction of the blood inflammatory indices,; 4. Incidence of renal scarring documented at 12 month.
D: The primary end-point is UTI Recurrence Rate during the 12-month observation period and the Development of renal damage (parenchymal scar) after 12 months.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Evaluation of the Addition of Intraoperative Intravenous Lidocaine Infusion to General Anesthetic in Total Abdominal Hysterectomy.
Brief Summary: The purpose of this study is to evaluate the efficacy of intravenous lidocaine infusion administered during general anesthesia in:

1. Reducing length of hospital stay following total abdominal hysterectomy
2. Reducing postoperative analgesic requirement following total abdominal hysterectomy.

Hypothesis:

The addition of an intraoperative lidocaine infusion to a balanced anesthetic technique will result in up to 50% of patients being discharged after postoperative day 2 compared with the current 21%. Also, it will result in a 30% reduction in opiod consumption during the first 48 hours following total abdominal hysterectomy.

Assumption:

Patients in the intervention and control groups will be titrated to approximately equal analgesia because they will self-administer enough pain-controlling medications to make their postoperative pain experience the same.

Primary outcomes:

1. Length of hospital stay
2. Total opioid use at 48 hours postoperatively

Secondary outcomes. The following data will be collected and analyzed:

1. Intraoperative data: BIS scores (to control depth of anesthesia); intraoperative serum lidocaine levels; intraoperative opioid use
2. Opioid use in the recovery room
3. Patient Controlled Analgesia (PCA) morphine requirements postoperatively up to 48 hours
4. Oral pain controlling medication use up to 48 hours postoperatively if IV PCA discontinued before 48 hours
5. Verbal Analogue Scale (VAS) pain scores in recovery room and during first 2 days post-operatively
6. Incidence of side effects that can be attributed to local anesthetic toxicity
7. Incidence of nausea and vomiting and anti-emetic use up to 48 hours postoperatively
8. Time of first flatus and first bowel movement.


Options:
A: time from end of surgery to first sign of bowel function (stool or flatus) (follow-up after surgery)
B: Postoperative pain measured using Visual analogue scale at postoperative 2hour (post op 2hour)
C: Length of hospital stay; Total opioid use at 48 hours postoperatively
D: The primary endpoint of this study was the QoR 40 (24 hours after the operation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Studying the Effects of Phosphatidylserine Enriched With Omega-3 Fatty Acids on Symptoms of Attention-Deficit/Hyperactivity Disorder in Children
Brief Summary: To determine whether supplementation of omega-3 long-chain polyunsaturated fatty acid conjugated to phosphatidylserine rather than triglycerides (fish oil) could affect Attention-deficit/hyperactivity disorder symptoms in children.


Options:
A: Change in ADHD RS-IV total score (Baseline, month 4, and month 6)
B: Laboratory assessment of inattention and impulsivity with Test of Variables of Attention (TOVA); Blood lipids profile
C: Change in reading ability (0, 3 and 6 months)
D: Cognitive control task - functional MRI (change over 16 week intervention period (pre/post))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase II Study of Docetaxel in Combination With Oxaliplatin With or Without 5-FU or Capecitabine in Metastatic or Locally Recurrent Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease
Brief Summary: This phase II study addressed the use of docetaxel in combination with oxaliplatin with or without 5-FU or capecitabine in metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease. Prior to this study a pilot phase I (part I) determined the optimal dose by assessing the safety and tolerability of 2 dose levels in each arm. The optimal dose was administered in the Part II study. Participants who received the optimal dose in each treatment arm in Part I were included in the Part II analysis population.

Primary objective:

* To assess the time to progression (TTP) of Docetaxel in combination with Oxaliplatin with or without 5-Fluorouracil (5-FU) or Capecitabine in metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease (part II).

Secondary objectives:

* To establish the safety profile.
* To assess the Overall Response Rate (ORR) based on the World Health Organization (WHO) criteria
* To assess the Overall Survival (OS)


Options:
A: Time to Progression (every 8 weeks up to a maximum of 36 months)
B: Recurrence of the original cancer (From the beginning to end of the study); Development of a new gastric cancer (From beginning to end of study); Death due to any cause (From the beginning to the end of study); Adverse events (From beginning to end of study); Clinical laboratory tests (From beginning to end of study)
C: median overall survival (2 years follow-up)
D: Number of Participants Experiencing Adverse Events (AEs) (Serious AEs: Up to 90 days after last dose of treatment (Up to 28 months); nonserious AEs: Up to 30 days after last dose of treatment (Up to 26 months) - through final analysis (FA) cutoff date 26 Apr 2016 (Cohorts: A, B, B2, D) & 01 Sep 2015 (Cohort C)); Number of Participants Discontinuing From Study Treatment Due to an AE (Up to last dose of study treatment (Up to approximately 25 months) - through FA cutoff date 26 Apr 2016 (Cohorts: A, B, B2, D) & 01 Sep 2015 (Cohort C)); Overall Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Response Rate Based on Blinded Independent Central Radiology (BICR) Review (Cohorts A, B, C, and D) (Every 8 weeks until disease progression (Cohorts A, B, D: Up to ~ 35 months; Cohort C: Up to ~ 28 months) - through FA cutoff date 26 Apr 2016 (Cohorts: A, B, D) & 01 Sep 2015 (Cohort C)); Overall RECIST 1.1 Response Rate Based on BICR Review for Participants in Cohort B2 (Every 8 weeks until disease progression (Up to ~ 35 months) - through FA cutoff date 26 Apr 2016)

Answer: A