TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Treating Co-Occurring Substance Use and Mental Disorders Among Jail Inmates
Brief Summary: Treatment adaptation and implementation study for adult jail inmates with co-occurring substance use disorders.


Options:
A: Time to post release treatment engagement (30 days post release); Reduction of HIV risk behaviors (12 months); Time to relapse (30 days post release); Cost effectiveness (12 months)
B: Acceptability (Study months 21 through 34)
C: A reduction in the use of drugs and alcohol (12 months)
D: Percentage of Those Maintain or Improve to HIV RNA-1 Viral Load Less Then 400 Copies/mL (Baseline to month 6 post release)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Dispensing Study to Assess Visual Performance of Prototype Contact Lenses
Brief Summary: The aim of this study is to assess visual performance of prototype soft contact lens designs compared to commercially available contact lenses over one-week of lens wear.


Options:
A: Tear film osmolarity (3 months)
B: Visual acuity on a LogMAR (logarithm of the minimum angle of resolution) scale (Approximately 1 week after lens fitting)
C: Change in visual performance over 1-week lens wear (after about 20 minutes of lens wear and after about 1 week of lens wear)
D: Number of Participants Developing a Corneal Inflammatory Event (CIE) (up to 1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: LATCH: Lactation Advice Thru Texting Can Help
Brief Summary: The purpose of this study is to find out if a two-way texting platform to be used as an adjunct tool for breastfeeding peer counselors can improve breastfeeding behaviors among women enrolled in the WIC program in Connecticut. The hypothesis of the study is that providing additional information and support through text messaging starting in pregnancy and continuing after the birth of the child will increase exclusive breastfeeding rates during the first six months of life.


Options:
A: Self-reported completion of a full course of PEP medications and receipt of a final HIV test result from their nPEP provider 12 weeks after the index exposure (12 weeks)
B: Change in Exclusive Breastfeeding Rate (2 weeks after birth); Change in Exclusive Breastfeeding Rate (3 months after birth); Change in Exclusive Breastfeeding Rate (6 months after birth)
C: Count of Women Who Have Excess Gestational Weight Gain (Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation))
D: Linkage to HIV Care (Indicated by a HIV-related Laboratory Blood Test Within 8 Months) (Recruitment +8 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: LATCH: Lactation Advice Thru Texting Can Help
Brief Summary: The purpose of this study is to find out if a two-way texting platform to be used as an adjunct tool for breastfeeding peer counselors can improve breastfeeding behaviors among women enrolled in the WIC program in Connecticut. The hypothesis of the study is that providing additional information and support through text messaging starting in pregnancy and continuing after the birth of the child will increase exclusive breastfeeding rates during the first six months of life.


Options:
A: Change in number of health behavior risks from Baseline at third trimester, 1 month post delivery, and 4 months post delivery (Third trimester of pregnancy, 1 month post delivery, 4 months post delivery); Change in number of minutes spent on stress management each day from Baseline at third trimester, 1 month post delivery, and 4 months post delivery (Third trimester of pregnancy, 1 month post delivery, 4 months post delivery); Change in number of servings of fruits and vegetables consumed each day from Baseline at third trimester, 1 month post delivery, and 4 months post delivery (Third trimester of pregnancy, 1 month post delivery, 4 months post delivery)
B: Change in Exclusive Breastfeeding Rate (2 weeks after birth); Change in Exclusive Breastfeeding Rate (3 months after birth); Change in Exclusive Breastfeeding Rate (6 months after birth)
C: Exclusive breastfeeding (6 months postpartum)
D: The Number of Condomless Sex Acts at 3-months Post-intervention (3-months post-intervention); Percent of Boys Reporting Abstinence at 3-months Post-intervention (3-months post-intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: LATCH: Lactation Advice Thru Texting Can Help
Brief Summary: The purpose of this study is to find out if a two-way texting platform to be used as an adjunct tool for breastfeeding peer counselors can improve breastfeeding behaviors among women enrolled in the WIC program in Connecticut. The hypothesis of the study is that providing additional information and support through text messaging starting in pregnancy and continuing after the birth of the child will increase exclusive breastfeeding rates during the first six months of life.


Options:
A: Short-term Exclusive Breastfeeding (24-hour recall) (Measured at 1 month post-delivery via tablet based survey AND independent verification phone survey within one week); Long-term Exclusive Breastfeeding (24-hour recall) (Measured at 5 months post-delivery via tablet based survey AND independent verification phone survey within one week)
B: Neonatal death (28 days)
C: Change in Exclusive Breastfeeding Rate (2 weeks after birth); Change in Exclusive Breastfeeding Rate (3 months after birth); Change in Exclusive Breastfeeding Rate (6 months after birth)
D: Self-reported adherence on antiretroviral therapy (12 months post-partum); Adherence on antiretroviral therapy (12 months post-partum); Adherence on antiretroviral therapy (infant) (12 months post-partum); Retention in care (12 months post-partum); Adherence on antiretroviral therapy (dried blood spots) (12 months post-partum)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: LATCH: Lactation Advice Thru Texting Can Help
Brief Summary: The purpose of this study is to find out if a two-way texting platform to be used as an adjunct tool for breastfeeding peer counselors can improve breastfeeding behaviors among women enrolled in the WIC program in Connecticut. The hypothesis of the study is that providing additional information and support through text messaging starting in pregnancy and continuing after the birth of the child will increase exclusive breastfeeding rates during the first six months of life.


Options:
A: Count of Women Who Have Excess Gestational Weight Gain (Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation))
B: The rate of the Exclusive Breastfeeding (from birth of baby to 6 months post birth)
C: Change in Exclusive Breastfeeding Rate (2 weeks after birth); Change in Exclusive Breastfeeding Rate (3 months after birth); Change in Exclusive Breastfeeding Rate (6 months after birth)
D: Proportion of timely and complete vaccine uptake after ISAP SMS Intervention (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: LATCH: Lactation Advice Thru Texting Can Help
Brief Summary: The purpose of this study is to find out if a two-way texting platform to be used as an adjunct tool for breastfeeding peer counselors can improve breastfeeding behaviors among women enrolled in the WIC program in Connecticut. The hypothesis of the study is that providing additional information and support through text messaging starting in pregnancy and continuing after the birth of the child will increase exclusive breastfeeding rates during the first six months of life.


Options:
A: Linkage to Care - Participants Who Received Cluster of Differentiation 4 (CD4) T-cell Count Test Result Within 3 Months of Testing HIV-positive (Binary) (3 months); Timely Antiretroviral Therapy (ART) Initiation (Participants Eligible for ART Who Initiate Treatment Within 3 Months of Diagnosis) (3 months); Retention in Care - ART Eligible (Participants Eligible for ART Who Initiated ART and Who Remain on Treatment) (12 months); Retention in Care - Non-ART (Participants Who Return for Repeat CD4 Testing Within 12 Months of Diagnosis) (12 months); Adherence to ART - Objective (Viral Load Test Results <400 Copies/mL) (12 months); Adherence to ART - Subjective (Self-reported Ability to Take ART as Prescribed in Last Month) (12 months)
B: Smoking status by collecting an expired carbon monoxide breath sample (3-Month Follow-Up)
C: Change in Exclusive Breastfeeding Rate (2 weeks after birth); Change in Exclusive Breastfeeding Rate (3 months after birth); Change in Exclusive Breastfeeding Rate (6 months after birth)
D: Influenza Immunization: Pediatric (March 31, 2011); Influenza Immunization: Pregnant Women (by December 31, 2011); Influenza Immunization: Delayed Pediatric (March 31, 2012)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: MEDication Focused Outpatient Care for Underutilization of Secondary Prevention
Brief Summary: The study tested whether a pharmacist-run cardiovascular risk service (CVRS) at the University of Iowa can increase use of national standards of care in clinics


Options:
A: The mean percent of applicable Guideline Advantage standards of care that are met at 12 months (12 months)
B: Reduction in total cholesterol in the entire SHCS population (18 months)
C: Discussion with provider about CHD risk reduction; Stated plans for CHD risk reduction
D: Processes of clinical care for diabetes; Cardiovascular risk as determined by UKPDS Risk; Metabolic outcomes (HgbA1c); Metabolic outcomes (LDL Cholesterol); Metabolic Outcomes (Systolic Blood Pressure)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Double Dummy, Comparative, Multicenter Study to Assess the Incidence of Hemolysis, Safety, and Efficacy of Tafenoquine (SB-252263, WR238605) Versus Primaquine in the Treatment of Subjects With Plasmodium Vivax Malaria
Brief Summary: This is a prospective, double-blind, double-dummy, multicenter, comparative study. A total of 300 subjects will be randomized to treatment on Day 1, of which a minimum of 50 female subjects must be enrolled that display moderate glucose-6-phosphate dehydrogenase (G6PD) deficiency (\>=40% - \<70% of the site median G6PD value). Subjects must have a blood smear that is positive for P. vivax at entry. Subjects will be randomized 2:1 to receive tafenoquine (TQ)/chloroquine(CQ) or the active comparator primaquine (PQ)/CQ. All subjects will receive CQ on Days 1 to 3, followed by TQ or PQ and matching placebo beginning on Day 1 or 2. Tafenoquine, or matching placebo, will be given as a single, 300mg dose. Subjects will receive PQ (15mg once daily) or matching placebo for 14 days. The duration of the study is 180 days, including screening and randomization to treatment (Day 1), three in-hospital days (Days 1-3), four out-patient visits while on treatment with study medication (Days 5, 8, 11 and 15) and seven follow-up visits (Days 22, 29, 60, 90, 120, 150 and 180).

The primary safety data collected in this study will help to understand the hemolysis risk to both G6PD-normal and G6PD-deficient subjects. The efficacy data produced from this study will support the results for sister study TAF112582, the pivotal phase III efficacy and safety study of the TQ program.


Options:
A: Number of Participants With Recurrence-free Efficacy at 6 Months Post Dose (6 months post dose)
B: Adequate Clinical Response (ACR) of Tafenoquine: 28 Day Cure Rate (28 Days)
C: Proportion of participants in the TQ group having retinal changes from Baseline in Central subfield thickness and Central retinal lesion thickness (Baseline and Day 90(follow-up)); Proportion of participants in the TQ group having retinal changes from Baseline in Total macular volume (Baseline and Day 90(follow-up)); Proportion of participants in the TQ group having retinal changes from Baseline in Ellipsoid zone disruption (Baseline and Day 90(follow-up)); Proportion of participants in the TQ group having retinal changes from Baseline in abnormal auto-fluorescence patterns (Baseline and Day 90(follow-up))
D: Percentage of Participants With Clinically Relevant Hemolysis. (Up to Day 180); Percentage of Female Participants With Moderate Glucose-6 Phosphate Dehydrogenase (G6PD) Deficiency Experiencing Clinically Relevant Hemolysis. (Up to Day 180)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Center Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder (OAB)
Brief Summary: The purpose of this study was to assess the efficacy, safety and tolerability of mirabegron versus placebo in the treatment of older adult subjects with OAB.


Options:
A: Change From Baseline to End of Treatment (EOT) in Mean Number of Micturitions Per 24 Hours (Baseline and EOT (up to 12 weeks)); Change From Baseline to EOT in Mean Number of Incontinence Episodes Per 24 Hours (Baseline and EOT (up to 12 weeks))
B: Change in appropriateness of anticholinergic medication prescribing practices. (Two years)
C: Successful medication discontinuation (4 months)
D: Total standardized daily dose (TSDD) - from medical records (12 months); Total standardized daily dose (TSDD) - self-report medication inventory (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomization of Endovascular Treatment With Stent-retriever and/or Thromboaspiration vs. Best Medical Therapy in Acute Ischemic Stroke Due to Large VEssel OcclusioN Trial
Brief Summary: Prospective, multi-center, randomized, controlled, open, blinded-endpoint trial with a sequential design. The randomization employs a 1:1 ratio of mechanical thrombectomy with stentriever and/or Thromboaspiration versus medical management alone. Randomization will be done under a minimization process using age, baseline NIHSS, use of IV tpa, vessel occlusion site and hospital. To evaluate the hypothesis that mechanical thrombectomy is superior to medical management alone in achieving more favorable outcomes in the distribution of the modified Rankin Scale scores at 90 days in subjects presenting with acute large vessel ischemic stroke \<8 hours from symptom onset. Subjects are either ineligible for IV alteplase or have received IV alteplase therapy without recanalization. Sample size is projected to be 690 patients for a difference in treatment effect of 10%.


Options:
A: modified Rankin Scale (mRS) (at 90 days from randomization)
B: Distribution of the modified Rankin Scale scores (shift analysis) (90 days)
C: Weighted Modified Rankin Scale (mRS) Score, Lead Co-Primary Efficacy Outcome (90 days); Functional Independence (mRS 0-2), Nested Co-Primary Efficacy Outcome (90 days); Stroke-related Mortality, Primary Safety Outcome (90 days)
D: Reperfusion at 24 hours (CT or MR perfusion imaging) (24 hours post stroke onset); Favourable clinical response at 3 days(National Institutes of Health Stroke Score - NIHSS) (3 days post stroke onset)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Nephrotic Syndrome Relapse With Low Steroid Dose
Brief Summary: Background- Idiopathic Nephrotic syndrome is the common glomerular disease in childhood. conventional treatment is steroid treatment and nearly 90% response to this treatment well.

Response to this treatment is the most important prognostic factor and this patients has a benign disease course.

60-70% among patients that response to steroid treatment,will suffer a relapse of NS.repeated steroids courses can lead to serious adverse events in children such as low bone density,weight gain ,growth slow down ,elevated blood pressure and eye pressure.there is side effect corelation between steroid dose and treatment duration.

guidelines for steroid dose for NS relapse are not based on retrospective clinical research but only on Nephrologists and experts opinion.

Rational- What would be the optimal low dose steroids and the shortest time of treatment in Nephrotic syndrome relapse?


Options:
A: Time to first relapse (5 months); Assessment of steroid induced morbidity (5 months)
B: Complete remission (24 hour urine protein < 0.3 g) (at 6 months)
C: Relapse of nephrotic syndrome during 12 months after randomization (12 month period following randomization)
D: Nephrotic Syndrome Remission (3 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Increasing Vegetable Intake in Children
Brief Summary: The purpose of this study is to test the feasibility of an innovative approach to increase the amount of vegetable's (V) intake consumed by preschool children who are predominately African-American (AA) and Hispanic-American (HA).


Options:
A: Vegetable Intake in Preschool Children (1 year 11 months)
B: Change in child adiposity from baseline measured via BMI z-score (Enrollment, 6 months, 12 months, 18 months, 24 months); Change in adult adiposity from baseline measured via BMI (Enrollment, 12 months, 24 months)
C: Change in EPAO-SR Scores from Baseline to Post-intervention (Measures collected at baseline (2-4 weeks prior to the intervention) and post-intervention (1-3 weeks following the intervention))
D: BMI and aerobic fitness (1 schoolyear)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Increasing Vegetable Intake in Children
Brief Summary: The purpose of this study is to test the feasibility of an innovative approach to increase the amount of vegetable's (V) intake consumed by preschool children who are predominately African-American (AA) and Hispanic-American (HA).


Options:
A: fasting blood glucose (Baseline to 10 months postpartum); weight (body mass index) (Baseline to 10 months postpartum)
B: 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
C: Vegetable Intake in Preschool Children (1 year 11 months)
D: Body mass index (2005, 2006, 2007, 2008); nutrition behavior (2005, 2006, 2007, 2008); physical activity (2005, 2006, 2007, 2008)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Increasing Vegetable Intake in Children
Brief Summary: The purpose of this study is to test the feasibility of an innovative approach to increase the amount of vegetable's (V) intake consumed by preschool children who are predominately African-American (AA) and Hispanic-American (HA).


Options:
A: body mass index (three years)
B: Vegetable Intake in Preschool Children (1 year 11 months)
C: Body Mass Index score(BMI sds) at the age 6 years to monitor the effectiveness of the intervention (5 years)
D: child nutritional status (Burundi: 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Increasing Vegetable Intake in Children
Brief Summary: The purpose of this study is to test the feasibility of an innovative approach to increase the amount of vegetable's (V) intake consumed by preschool children who are predominately African-American (AA) and Hispanic-American (HA).


Options:
A: Vegetable Intake in Preschool Children (1 year 11 months)
B: Body mass index (2005, 2006, 2007, 2008); nutrition behavior (2005, 2006, 2007, 2008); physical activity (2005, 2006, 2007, 2008)
C: fasting blood glucose (Baseline to 10 months postpartum); weight (body mass index) (Baseline to 10 months postpartum)
D: 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.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Increasing Vegetable Intake in Children
Brief Summary: The purpose of this study is to test the feasibility of an innovative approach to increase the amount of vegetable's (V) intake consumed by preschool children who are predominately African-American (AA) and Hispanic-American (HA).


Options:
A: Vegetable Intake in Preschool Children (1 year 11 months)
B: Change in Percentage of Children Meeting Physical Activity Policy (Spring of Year 1, Year 2, and Year 3)
C: 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
D: Satisfaction and Exit Survey Composite Scale Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE (6 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Eeva™ Pregnancy Pilot Study (PPS)
Brief Summary: The purpose of this clinical investigation is to gather pilot data to evaluate the impact of using Eeva™, a time-lapse enabled embryo test, in combination with traditional morphology on clinical pregnancy rates.


Options:
A: live birth rate (10 months for group A, 12 months for group B)
B: Clinical Pregnancy (7-8 weeks gestation)
C: Live birth rate (up to 24 weeks)
D: Clinical pregnancy rates (7 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Developing a Smartphone App With Mindfulness Training for Teen Smoking Cessation
Brief Summary: The recent Surgeon General's Report calls for effective and readily available treatment approaches to help adolescent smokers interested in quitting. Schools are an ideal venue for connecting adolescent smokers with smoking cessation assistance. This study will adapt the Craving to Quit (C2Q) smartphone app, which integrates mindfulness training into a smoking cessation program, for teen smokers (C2Q-Teen). We will test how well this novel app helps teens stop smoking compared to another teen smoking cessation app that does not include mindfulness training, and to written cessation information alone. If effective, the C2Q-Teen would be relatively easy to disseminate widely and have tremendous public health significance


Options:
A: Number of Participants Who Stopped Smoking by 6 Month Post Treatment (6 months)
B: Assess emotional states of depression, anxiety and stress. (At 3 months); Assess emotional states of depression, anxiety and stress. (At 6 months); Assess emotional states of depression, anxiety and stress. (At 24 months)
C: Smoking Abstinence Rate (Baseline up to 6 weeks)
D: Feasibility of study recruitment into the three interventions (Baseline); Feasibility of retention of participants at 3-month follow-up (3-month follow-up); Feasibility of retention of participants at 6-month follow-up (6-month follow-up); Acceptability of the three interventions (3-month follow-up)

Answer: D