TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Complementary Feeding - A Global Network Cluster Randomized Controlled Trial
Brief Summary: The specific aims of this project is to determine the impact of a daily intake of one half ounce of lyophilized meat between 6-18 months of age (0.5 oz for 6-12 mo; 0.75 oz for 12-18 mo) on linear growth velocity, zinc and iron intakes and status, brain growth and neurocognitive development, and infectious disease morbidity in populations traditionally dependent on non-micronutrient fortified plant foods for complementary feeding.


Options:
A: Linear growth velocity (6 to 18 months of age)
B: IQ score (Aug 2007-Jan 2008)
C: proportion with treatment failures (Within 3 weeks after enrollment)
D: Preventive effect of zinc therapy on diarrhoea during the subsequent three month 14 days of enrollment; Assess the acceptability of zinc therapy during diarrhoea in young children.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Complementary Feeding - A Global Network Cluster Randomized Controlled Trial
Brief Summary: The specific aims of this project is to determine the impact of a daily intake of one half ounce of lyophilized meat between 6-18 months of age (0.5 oz for 6-12 mo; 0.75 oz for 12-18 mo) on linear growth velocity, zinc and iron intakes and status, brain growth and neurocognitive development, and infectious disease morbidity in populations traditionally dependent on non-micronutrient fortified plant foods for complementary feeding.


Options:
A: Mean birth weight (9 months)
B: Haemoglobin; Plasma Ferritin; Plasma Transferrin receptor
C: Hemoglobin (Start of study (T=0), End of study (T=4months))
D: Linear growth velocity (6 to 18 months of age)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Complementary Feeding - A Global Network Cluster Randomized Controlled Trial
Brief Summary: The specific aims of this project is to determine the impact of a daily intake of one half ounce of lyophilized meat between 6-18 months of age (0.5 oz for 6-12 mo; 0.75 oz for 12-18 mo) on linear growth velocity, zinc and iron intakes and status, brain growth and neurocognitive development, and infectious disease morbidity in populations traditionally dependent on non-micronutrient fortified plant foods for complementary feeding.


Options:
A: Incidence of Stunting of Linear Growth (18 months of age)
B: Linear growth velocity (6 to 18 months of age)
C: Linear Growth (6-18 mos of age)
D: Change of linear growth (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Complementary Feeding - A Global Network Cluster Randomized Controlled Trial
Brief Summary: The specific aims of this project is to determine the impact of a daily intake of one half ounce of lyophilized meat between 6-18 months of age (0.5 oz for 6-12 mo; 0.75 oz for 12-18 mo) on linear growth velocity, zinc and iron intakes and status, brain growth and neurocognitive development, and infectious disease morbidity in populations traditionally dependent on non-micronutrient fortified plant foods for complementary feeding.


Options:
A: Weight, length and Rohrer index at birth, and gestational duration in singleton pregnancies. (At birth); Mortality, morbidity and growth during the first year of life (Monthly during infancy)
B: Change From Baseline in Maximal Aerobic Capacity (VO2max)- 12 Inch Step Test After 4 Months (Baseline, after 4 months); Change From Baseline in Aerobic Capacity-shuttle Test (VO2peak) After 4 Months (Baseline, after 4 months); Change From Baseline in Time Taken for 40 Meter (m) Sprint After 4 Months (Baseline, after 4 months); Change From Baseline in Visual Reaction Time After 4 Months (Baseline, after 4 months)
C: Linear growth velocity (6 to 18 months of age)
D: Diarrhea; Pneumonia; Febrile illness; Growth; Development; Activity

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of Stress Levels in Consumers Using Ovulation Tests in Order to Conceive
Brief Summary: Approximately 150 female volunteers wishing to become pregnant will be recruited via web recruitment from around the UK and randomised 1:1 to receive Clearblue Digital ovulation tests (active arm) or no aid to conception (control arm) for 2 full menstrual cycles. All volunteers will complete study questionnaires and provide a urine sample at designated time points though out the menstrual cycle.

A sub-arm to this study, applied the same protocol to women in an infertility treatment setting; Royal Hallamshire Hospital, Sheffield. Additional exclusion criteria were applied to this cohort; had regular menstrual cycles between 25 and 35 days, and who did not have a diagnosis of bilateral or unilateral tubal blockage, documented anovulation or severe male-factor infertility (with \<5 million motile sperm per ejaculate). For this arm, the protocol was reviewed by Sheffield Research Ethics Committee 09/H1308/134.


Options:
A: Unintended Pregnancies (1, 3, 6, and 12 months)
B: Change in sexual functioning over the course of one year (T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later])
C: Cortisol Measurement (Twice monthly)
D: Collection of early pregnancy urine samples. (60 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Abstract

Background: Insulin resistance has an important role in the development of nonalcoholic fatty liver disease (NAFLD) and is involved in both pathological processes: hepatic steatosis and atherosclerosis. Therefore, treatment of NAFLD with insulin sensitizers is likely to have a favorable effect towards hepatic steatosis and cardiovascular outcomes.

Objectives: The present study investigated the effect of metformin on arterial properties, metabolic parameters and liver function in patients with NAFLD. Methods In randomized, placebo controlled study, 63 patients with NAFLD were assigned to one of two groups: Group 1 received daily metformin; Group 2 received placebo. Pulse wave velocity (PWV) and augmentation index (AI) were performed using SphygmoCor (version 7.1, AtCor Medical, Sydney, Australia) at baseline and at the end of 4-month treatment period.. Metabolic measures and serum adiponectin levels were determined.


Options:
A: Change in Liver Fat as Measured by MRI-PDFF (Baseline, 24 weeks)
B: N/A
C: The difference between initial and final liver triglyceride concentration (measured by NMRS) comparing the Aramchol and placebo treated patients. (3 months)
D: Improved metabolic parameters(glucose, lipid, liver enzymes, etc.) (16 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Healthy Homes/Healthy Kids: Pediatric Primary Care-based Obesity Prevention
Brief Summary: The pediatric primary care setting is a relatively untapped resource for addressing obesity prevention. The main goal of this study is to evaluate the efficacy of a relatively low cost pediatric primary-care based obesity prevention intervention. The intervention will consist of brief pediatrician counseling as well as phone coaching for parents with overweight children who are between the ages of five and nine. We propose to enroll and randomize 425 parent-child dyads with children who have a measured body mass index (BMI) the 75th and 95th percentile. They will be randomized one of into two groups, the (a) Healthy Eating/Physical Activity Intervention, or the (b) General Healthy/Safety/Injury Prevention Contact Control Intervention. Both groups will receive brief pediatrician counseling regarding their child's current BMI percentile status and recommendations for home environmental changes to achieve a healthy weight gain trajectory and to improve home safety and reduce injury risk. This will be paired with a 12 month home-based program delivered via phone by health behavior specialists to help parents make environmental changes specific to their group assignment.


Options:
A: Change in BMIz (Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).)
B: BMI percentile change (24 months)
C: Frequency of exclusive and total breastfeeding (First year)
D: BMI z-score (via measured weight and height) of preschooler (~2 years post baseline)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Transdermal Nicotine Therapy as an Adjunct to Behavioral Smoking Cessation Counseling in Syrian Primary Care Settings
Brief Summary: The study is a two-arm, parallel group, randomized, placebo-controlled, double blind trial, conducted at four primary health care centers in Aleppo, Syria, to test the efficacy of transdermal nicotine patch therapy vs. placebo patch therapy, when delivered with behavioral counseling, on smoking cessation rates.


Options:
A: Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint (Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.); Estimated NPS AE Rate (%), by Cohort (Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.)
B: Prolonged Abstinence (7 weeks, 6 months and 12 months)
C: 7-day Point Prevalence Quit Rate at End-of-Treatment (EOT) (Week 11)
D: The daily number of intakes during the first three weeks recorded with an electronic device fixed on the spray unit (microswitch-actuated metered-dose inhaler chronology, MDILog™, model MDC-511, Medtrac, Denver, Colorado). (first 3 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind (Test Products and Placebo), Chronic Dosing (7 Days), Four-Period, Eight-Treatment, Placebo-Controlled, Incomplete Block, Cross-Over, Multi-Center Study to Assess Efficacy and Safety of Two Doses of PT003, Two Doses of PT005 and One Dose of PT001 in Patients With Moderate to Very Severe COPD, Compared With Foradil® Aerolizer® (12 μg, Open-Label) and Spiriva® Handihaler® (18 μg, Open-Label) as Active Controls
Brief Summary: The purpose of this study is to evaluate, after 1 week of dosing, the efficacy and safety of PT003 compared with its individual components (PT001 and PT005), placebo and two active comparators to demonstrate superiority of the combination to its components, and to assess the relative contribution of the components compared with placebo, in patients with moderate to very severe COPD.


Options:
A: Inspiratory Capacity at Rest Before Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Work Capacity (6 weeks); Endurance Time During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap (6 weeks)
B: Change From Baseline in Clinic Visit Trough Forced Expiratory Volume in One Second (FEV1) at Day 169 (Baseline and Day 169)
C: Inspiratory Capacity (IC) Peak Value (Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours)
D: FEV1 AUC 0-12 on Day 7 ("Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 10, 11.5, and 12 hours post-dose on Day 7)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety of Adenosine 2A Agonist Lexiscan in Children and Adults With Sickle Cell Disease
Brief Summary: Sickle cell disease (SCD) is an inherited blood disorder that causes the red blood cells to change their shape from a round shape to a half-moon/crescent or sickled shape. People who have SCD have a different type of protein that carries oxygen in their blood (hemoglobin) then people without SCD. This different type of hemoglobin makes the red blood cells change into a crescent shape under certain conditions. Sickle-shaped cells are a problem because they often get stuck in blood vessels blocking the flow of blood, and cause inflammation and injury to the important areas in the body. Lexiscan is drug that may prevent this inflammation and injury caused by the sickle shaped cells. This drug is approved by the FDA to be used as a fast infusion during a heart stress test in people who are unable to exercise enough to put stress on their heart by making it beat faster. Lexiscan has never been studied in patients with SCD and has never been given as a long infusion.


Options:
A: Dose Limiting Toxicities as a Measure of Whether Infusional Lexiscan is Safe in Individuals With SCD. (30 to 54 hours plus 30-day follow-up)
B: Hospital Length of Stay (Hours) (From the time of the start of first study med infusion until hospital discharge or 12 hours after the last IV opioid, whichever occurs first, up to 10 days post enrollment)
C: Distribution of the Density of Hemoglobin SC Red Cells (measured 2 months after initiation of treatment)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety of Adenosine 2A Agonist Lexiscan in Children and Adults With Sickle Cell Disease
Brief Summary: Sickle cell disease (SCD) is an inherited blood disorder that causes the red blood cells to change their shape from a round shape to a half-moon/crescent or sickled shape. People who have SCD have a different type of protein that carries oxygen in their blood (hemoglobin) then people without SCD. This different type of hemoglobin makes the red blood cells change into a crescent shape under certain conditions. Sickle-shaped cells are a problem because they often get stuck in blood vessels blocking the flow of blood, and cause inflammation and injury to the important areas in the body. Lexiscan is drug that may prevent this inflammation and injury caused by the sickle shaped cells. This drug is approved by the FDA to be used as a fast infusion during a heart stress test in people who are unable to exercise enough to put stress on their heart by making it beat faster. Lexiscan has never been studied in patients with SCD and has never been given as a long infusion.


Options:
A: N/A
B: Dose Limiting Toxicities as a Measure of Whether Infusional Lexiscan is Safe in Individuals With SCD. (30 to 54 hours plus 30-day follow-up)
C: Hospital Length of Stay (Hours) (From the time of the start of first study med infusion until hospital discharge or 12 hours after the last IV opioid, whichever occurs first, up to 10 days post enrollment)
D: Length of stay in the hospital (Time frame determined by outcome)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Comparative, MultiCenter Clinical Study to Assess the Safety and Effectiveness of the Transcend CyPass Glaucoma Implant in Patients With Open Angle Glaucoma Undergoing Cataract Surgery
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of the CyPass Implant for lowering intraocular pressure (IOP) in patients with glaucoma who undergo cataract surgery.


Options:
A: Mean IOP at 6 months (6 months); Surgical complication rates (intraoperative and postoperative up to 12 months)
B: Change in Intraocular Pressure (Baseline to 5 years); Rate of Complications (5 years)
C: Number of Participants With > 20% Decrease in Mean Diurnal Intraocular Pressure (12 months); Number of Participants With > 20% Decrease in Diurnal Intraocular Pressure (24 months)
D: Proportion of Eyes With ≥ 20% Decrease in Intraocular Pressure (IOP) From Baseline to the Hypotensive Medication-free 24-month Postoperative Examination Using Non-responder Imputation for Missing Data (Baseline; Month 24 postoperative)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of a Pharmaceutical Intervention on the Level of Control of the Asthmatic Patient
Brief Summary: Measurement of disease control, treatment adherence and patient knowledge of his/her medication in patients that are receiving a pharmaceutical intervention compared with those patients who receive regular pharmaceutical care.


Options:
A: The primary outcome will be the difference in proportion of patients who receive ≥ 5 of the Arthritis Foundation's quality indicators during the six months of the study. (6 months); (Baseline, months 2 and 6 ) (Months 2 and 6)
B: Evaluate the effect of the pharmaceutical intervention on the disease control, treatment adherence and patient knowledge of his/her medication using the MEF, treatment adherence and patient knowledge of the medication indicators. (First a Pilot in 3 months and then the final study in 6 months)
C: Adherence to inhaled corticosteroid medication (12 months)
D: Quality of life. (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of a Pharmaceutical Intervention on the Level of Control of the Asthmatic Patient
Brief Summary: Measurement of disease control, treatment adherence and patient knowledge of his/her medication in patients that are receiving a pharmaceutical intervention compared with those patients who receive regular pharmaceutical care.


Options:
A: Evaluate the effect of the pharmaceutical intervention on the disease control, treatment adherence and patient knowledge of his/her medication using the MEF, treatment adherence and patient knowledge of the medication indicators. (First a Pilot in 3 months and then the final study in 6 months)
B: Anticoagulation-related quality of life (Four months)
C: systolic blood pressure (6 months)
D: Medication adherence; Exacerbation of heart failure; Health-related quality of life

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of a Pharmaceutical Intervention on the Level of Control of the Asthmatic Patient
Brief Summary: Measurement of disease control, treatment adherence and patient knowledge of his/her medication in patients that are receiving a pharmaceutical intervention compared with those patients who receive regular pharmaceutical care.


Options:
A: Change in inhaler, turbuhaler, and diskus technique (Baseline and 1-month follow-up)
B: Adherence rate (at three months)
C: Evaluate the effect of the pharmaceutical intervention on the disease control, treatment adherence and patient knowledge of his/her medication using the MEF, treatment adherence and patient knowledge of the medication indicators. (First a Pilot in 3 months and then the final study in 6 months)
D: Percentage of Participants With MDI Misuse From Baseline to 30 Days Post-Discharge (1 month)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of a Pharmaceutical Intervention on the Level of Control of the Asthmatic Patient
Brief Summary: Measurement of disease control, treatment adherence and patient knowledge of his/her medication in patients that are receiving a pharmaceutical intervention compared with those patients who receive regular pharmaceutical care.


Options:
A: Change in baseline asthma self efficacy after 3 weeks (participants will be followed for an average of 4 weeks, with this measure collect at the beginning of the period and after 3 weeks of reminders.)
B: Adherence rate to daily inhaled steroids, reported as the ratio of the sum of number of recorded over prescribed activation per day during the 28 days following the index visit.
C: Evaluate the effect of the pharmaceutical intervention on the disease control, treatment adherence and patient knowledge of his/her medication using the MEF, treatment adherence and patient knowledge of the medication indicators. (First a Pilot in 3 months and then the final study in 6 months)
D: medication adherence, parental involvement , perceived parent-adolescent conflict, associated health outcome

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blinded, Active-Controlled, Dose Ranging Study of CB-183,315 in Patients With Clostridium Difficile Infection.
Brief Summary: This is a randomized, double-blind, single-placebo, active-controlled, dose ranging parallel group design with 3 arms. Two dose regimens of CB-183,315 dosed twice daily will be compared with the active comparator oral vancomycin (125 milligrams (mg ) four times daily). Participants with diarrhea at risk for Clostridium difficile infection (CDI) \[for example, received prior or concomitant antibiotic(s)\] will be identified and tested for C. difficile toxin in stool using an enzyme immunoassay (EIA), or polymerase chain reaction (PCR) per the usual standard of care. Eligible participants will be consented, undergo baseline evaluations, and will be randomized in a blinded fashion to one of 3 treatment arms.

Participants will be randomized to receive either 125 mg CB-183,315 twice daily alternating with placebo tablets twice daily, 250 mg CB-183,315 twice daily alternating with placebo tablets twice daily or 125 mg oral vancomycin four times dailyover a period of 10 days in a 1:1:1 fashion.


Options:
A: Cure Rate at End of Therapy (Study day 10 (+/- 2 days))
B: Number of Participants With a Clinical Response Outcome of Clostridium Difficile Infection Cure at the End of Study Treatment (Baseline (Day 0) through Study Day 19); Number of Participants With a Clinical Response Outcome of Failure or Unable to Evaluate at the End of Study Treatment (Baseline (Day 0) through Study Day 19)
C: The evaluation of the safety of HBT (13 Weeks post HBT); To determine the cure rate without recurrence of CDI at 13 weeks from the last HBT. (13 Weeks post HBT)
D: Duration of diarrhea (4 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Procalcitonin-guided Algorithms of Antibiotic Stewardship in the Intensive Care Unit: Systematic Review and Meta-analysis
Brief Summary: Sepsis is common and is associated with significant mortality, morbidity and health-care costs. Unfortunately, its diagnosis is not straightforward because its signs and symptoms are neither specific nor sensitive; in addition, microbiological cultures lack specificity, sensitivity and are plagued by high turn-around times. Because the delay in the institution of antimicrobial therapy may be deleterious, broad-spectrum antibiotics are widely used in ICU-patients, even when they are not needed. Procalcitonin may not be the long sought for bio-marker to establish the diagnosis of sepsis but may help decrease the duration of the administered antibiotic courses once they are started.


Options:
A: Mortality (28 days); Consumption of antibiotics expressed as the Defined Daily Dosage and duration of antibiotic therapy expressed in days of therapy. (Between day 1 and D28); Mortality (1 year)
B: Duration of antibiotic treatment for the first episode of infection; Total duration of antibiotic therapy; Antibiotic-free days at 28 days after study enrollment
C: mortality/survival (28 day)
D: Exposition to antibiotics, defined by antibiotic-free days (assessed 28 days after inclusion); Mortality (at Day 28 and Day 60)

Answer: B