TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing Retention in PMTCT/MNCH Services and Facility Delivery in Tabora, Tanzania
Brief Summary: The goal of this proposed intervention study is to increase the proportion of HIV positive and HIV negative pregnant women who deliver in a facility, the proportion of HIV exposed infants (HEI) who receive nevirapine (NVP) within 48 hours of delivery, and the proportion of HEI who are bled for HIV polymerase chain reaction (PCR) deoxyribonucleic acid (DNA) testing within 8 weeks of age.


Options:
A: HPV completion rate (One Year)
B: Exclusive breastfeeding (6 months postpartum)
C: Attendance for Early infant diagnosis (EID) of HIV (1 year); Early identification of HEI at Reproductive and Child Health (RCH) Clinic (1 year); Antenatal care (ANC) visits (1 year); Facility delivery (1 year); Post natal care (PNC) visits (1 year); Nevirapine (NVP) at delivery (1 year)
D: Exclusive breastfeeding duration (Six months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing Retention in PMTCT/MNCH Services and Facility Delivery in Tabora, Tanzania
Brief Summary: The goal of this proposed intervention study is to increase the proportion of HIV positive and HIV negative pregnant women who deliver in a facility, the proportion of HIV exposed infants (HEI) who receive nevirapine (NVP) within 48 hours of delivery, and the proportion of HEI who are bled for HIV polymerase chain reaction (PCR) deoxyribonucleic acid (DNA) testing within 8 weeks of age.


Options:
A: Attendance for Early infant diagnosis (EID) of HIV (1 year); Early identification of HEI at Reproductive and Child Health (RCH) Clinic (1 year); Antenatal care (ANC) visits (1 year); Facility delivery (1 year); Post natal care (PNC) visits (1 year); Nevirapine (NVP) at delivery (1 year)
B: Difference in Number and proportion of adults responding to standard appointment versus intense follow up. (2 weeks)
C: Count of Women Who Have Excess Gestational Weight Gain (Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation))
D: Receipt of 2nd Dose of the Influenza Vaccine. (by April 30th after receipt of first dose (up to 8 months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing Retention in PMTCT/MNCH Services and Facility Delivery in Tabora, Tanzania
Brief Summary: The goal of this proposed intervention study is to increase the proportion of HIV positive and HIV negative pregnant women who deliver in a facility, the proportion of HIV exposed infants (HEI) who receive nevirapine (NVP) within 48 hours of delivery, and the proportion of HEI who are bled for HIV polymerase chain reaction (PCR) deoxyribonucleic acid (DNA) testing within 8 weeks of age.


Options:
A: Attendance for Early infant diagnosis (EID) of HIV (1 year); Early identification of HEI at Reproductive and Child Health (RCH) Clinic (1 year); Antenatal care (ANC) visits (1 year); Facility delivery (1 year); Post natal care (PNC) visits (1 year); Nevirapine (NVP) at delivery (1 year)
B: The primary outcome will measure the number of children who got vaccinated for routine immunization scheduled at 6, 10 and 14 weeks of life (Vaccination status at 20th week of life of the particpants)
C: Improved immunization coverage (At the completion of all recruitment and follow ups which will take an average time of 1 year)
D: Proportion of fully immunized children (When the participants reach 2 years of age)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing Retention in PMTCT/MNCH Services and Facility Delivery in Tabora, Tanzania
Brief Summary: The goal of this proposed intervention study is to increase the proportion of HIV positive and HIV negative pregnant women who deliver in a facility, the proportion of HIV exposed infants (HEI) who receive nevirapine (NVP) within 48 hours of delivery, and the proportion of HEI who are bled for HIV polymerase chain reaction (PCR) deoxyribonucleic acid (DNA) testing within 8 weeks of age.


Options:
A: Smoking status by collecting an expired carbon monoxide breath sample (3-Month Follow-Up)
B: Attendance for Early infant diagnosis (EID) of HIV (1 year); Early identification of HEI at Reproductive and Child Health (RCH) Clinic (1 year); Antenatal care (ANC) visits (1 year); Facility delivery (1 year); Post natal care (PNC) visits (1 year); Nevirapine (NVP) at delivery (1 year)
C: Contraceptive uptake (10 weeks postpartum; 24 weeks postpartum); Facility Delivery (Postpartum); Exclusive Breastfeeding (24 weeks postpartum)
D: Proportion of Patients Who Receive a Pap Test at End of Follow up (18 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Scale Up Evaluation of a Physical Activity Program for Adults With Physical Disability
Brief Summary: The study uses a theory-driven eHealth platform and innovative physical activity (PA) program referred to as movement-to-music (M2M) to deliver a customized, home-based PA intervention for adults with physical disability (PWD). Participants will be recruited through a large physical medicine and rehabilitation network of clinics specializing in treating patients with physical disability. Participants will be randomized to one of three groups: a) M2M; b) M2M plus social networking (M2Mplus); and c) attention control (AC). Participants will be followed for 48 weeks to obtain objective measures on physical activity, fitness and self-reported measures on health at four time points. The study will compare the effectiveness of M2M and M2Mplus in increasing physical activity and adherence compared to the AC group, estimate the improvements in health of M2M and M2Mplus compared to the AC group, and examine the mediators and moderators of the hypothesized treatment effect to understand for whom and how the intervention is effective. This multi-level, scalability study will strengthen our understanding of the potential benefits of eHealth to eliminate barriers to PA participation among PWD.


Options:
A: Physical Activity (48 weeks); Completing program content (48 weeks)
B: Change from baseline peak VO2 (ml/kg/min) at 12 week (Baseline, 12 week); Change from baseline MLHFQ at 12 week (Baseline,12 week)
C: Composite of COPD Hospital Readmission/Death Within 6 Month of Discharge (6 months post-discharge from hospitalization following COPD exacerbation)
D: Change in VO2peak (day1); Change in VO2peak (month 2 + 14 days); Change in VO2peak (month 4 + 14 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation Following Text Message Intervention in Pregnant Women
Brief Summary: The investigators propose an 18-month, randomized, open-label evaluation of the impact of texting to pregnant, underserved, cigarette smokers on smoking cessation rates. Patients will be eligible if they have a confirmed pregnancy, are English speaking, at least 18 years of age, are in the preparation stage of change and willing to set a quit date within 30 days and before 35 weeks gestation, and have a cellular phone that is capable of receiving text messages. Patients will be randomized to either the texting group or control group. A baseline carbon monoxide level will be obtained. The patient, regardless of group, will have the standard of care smoking cessation visit. If the pharmacist, physician, and patient deem that pharmacotherapy is appropriate, patient will receive nicotine replacement therapy patches or bupropion free of charge in 2-week intervals. Patients in the intervention group will receive text messages focused on smoking cessation and pregnancy. Patients will be seen on a bi-weekly schedule to obtain additional vouchers for patches or for bupropion, meet with the pharmacist, and complete a carbon monoxide exhalation test. These visits will be continued until the pharmacotherapy course is complete.


Options:
A: MV Coverage at 12 months of age (12 months of age)
B: Exhaled Carbon Monoxide Levels (1 month)
C: Adherence to PrEP (Baseline to Week 48)
D: Unprotected sex, no contraceptive (6-week post-baseline (in the past 6 weeks)); Unprotected sex, no highly effective contraceptive (6-week post-baseline (in the past 6 weeks))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation Following Text Message Intervention in Pregnant Women
Brief Summary: The investigators propose an 18-month, randomized, open-label evaluation of the impact of texting to pregnant, underserved, cigarette smokers on smoking cessation rates. Patients will be eligible if they have a confirmed pregnancy, are English speaking, at least 18 years of age, are in the preparation stage of change and willing to set a quit date within 30 days and before 35 weeks gestation, and have a cellular phone that is capable of receiving text messages. Patients will be randomized to either the texting group or control group. A baseline carbon monoxide level will be obtained. The patient, regardless of group, will have the standard of care smoking cessation visit. If the pharmacist, physician, and patient deem that pharmacotherapy is appropriate, patient will receive nicotine replacement therapy patches or bupropion free of charge in 2-week intervals. Patients in the intervention group will receive text messages focused on smoking cessation and pregnancy. Patients will be seen on a bi-weekly schedule to obtain additional vouchers for patches or for bupropion, meet with the pharmacist, and complete a carbon monoxide exhalation test. These visits will be continued until the pharmacotherapy course is complete.


Options:
A: Exhaled Carbon Monoxide Levels (1 month)
B: Use of long acting and reversible contraceptive at 4 months (4 months)
C: contraceptive continuation (6 months)
D: Measles - 2 Completion (When the participants reach 2 years of age)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation Following Text Message Intervention in Pregnant Women
Brief Summary: The investigators propose an 18-month, randomized, open-label evaluation of the impact of texting to pregnant, underserved, cigarette smokers on smoking cessation rates. Patients will be eligible if they have a confirmed pregnancy, are English speaking, at least 18 years of age, are in the preparation stage of change and willing to set a quit date within 30 days and before 35 weeks gestation, and have a cellular phone that is capable of receiving text messages. Patients will be randomized to either the texting group or control group. A baseline carbon monoxide level will be obtained. The patient, regardless of group, will have the standard of care smoking cessation visit. If the pharmacist, physician, and patient deem that pharmacotherapy is appropriate, patient will receive nicotine replacement therapy patches or bupropion free of charge in 2-week intervals. Patients in the intervention group will receive text messages focused on smoking cessation and pregnancy. Patients will be seen on a bi-weekly schedule to obtain additional vouchers for patches or for bupropion, meet with the pharmacist, and complete a carbon monoxide exhalation test. These visits will be continued until the pharmacotherapy course is complete.


Options:
A: Postpartum Contraceptive Uptake (Through study completion, an average of six months); Skilled Birth (Through study completion, an average of six months); Immunisation (Through study completion, an average of six months)
B: MV Coverage at 12 months of age (12 months of age)
C: Exhaled Carbon Monoxide Levels (1 month)
D: Completion of 3 Doses of Pentavalent Vaccine (8 months of age)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation Following Text Message Intervention in Pregnant Women
Brief Summary: The investigators propose an 18-month, randomized, open-label evaluation of the impact of texting to pregnant, underserved, cigarette smokers on smoking cessation rates. Patients will be eligible if they have a confirmed pregnancy, are English speaking, at least 18 years of age, are in the preparation stage of change and willing to set a quit date within 30 days and before 35 weeks gestation, and have a cellular phone that is capable of receiving text messages. Patients will be randomized to either the texting group or control group. A baseline carbon monoxide level will be obtained. The patient, regardless of group, will have the standard of care smoking cessation visit. If the pharmacist, physician, and patient deem that pharmacotherapy is appropriate, patient will receive nicotine replacement therapy patches or bupropion free of charge in 2-week intervals. Patients in the intervention group will receive text messages focused on smoking cessation and pregnancy. Patients will be seen on a bi-weekly schedule to obtain additional vouchers for patches or for bupropion, meet with the pharmacist, and complete a carbon monoxide exhalation test. These visits will be continued until the pharmacotherapy course is complete.


Options:
A: Contraceptive uptake (10 weeks postpartum; 24 weeks postpartum); Facility Delivery (Postpartum); Exclusive Breastfeeding (24 weeks postpartum)
B: Full on time early vaccination coverage (OPV0 and BCG) (First month of life)
C: Exhaled Carbon Monoxide Levels (1 month)
D: 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)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation Following Text Message Intervention in Pregnant Women
Brief Summary: The investigators propose an 18-month, randomized, open-label evaluation of the impact of texting to pregnant, underserved, cigarette smokers on smoking cessation rates. Patients will be eligible if they have a confirmed pregnancy, are English speaking, at least 18 years of age, are in the preparation stage of change and willing to set a quit date within 30 days and before 35 weeks gestation, and have a cellular phone that is capable of receiving text messages. Patients will be randomized to either the texting group or control group. A baseline carbon monoxide level will be obtained. The patient, regardless of group, will have the standard of care smoking cessation visit. If the pharmacist, physician, and patient deem that pharmacotherapy is appropriate, patient will receive nicotine replacement therapy patches or bupropion free of charge in 2-week intervals. Patients in the intervention group will receive text messages focused on smoking cessation and pregnancy. Patients will be seen on a bi-weekly schedule to obtain additional vouchers for patches or for bupropion, meet with the pharmacist, and complete a carbon monoxide exhalation test. These visits will be continued until the pharmacotherapy course is complete.


Options:
A: Exhaled Carbon Monoxide Levels (1 month)
B: Skilled delivery attendance (From inclusion to 42 days after delivery. Asssessed at delivery and confirmed 42 days after delivery)
C: Linkage to HIV Care (Indicated by a HIV-related Laboratory Blood Test Within 8 Months) (Recruitment +8 months)
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: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of the Oral Stimulation Program in Extreme Preterm Infants: A Randomized Clinical Trial
Brief Summary: The purpose of this study is to determine whether oral stimulation program are effective to improve oral feeding efficiency. The sample size estimated in 74 preterm, randomized classification of the subjects into to experimental and a control group.


Options:
A: Oral feeding performance (20 minutes)
B: Salivary gene expression (Quantify gene expression probability from salivary samples beginning at 30 wks post-menstrual age, and repeated sampling every 3 days thereafter during the infant's stay in neonatal intensive care unit (NICU) for an average of 14 samples, up to 60 days.)
C: N/A
D: The Median Breast Feeding Score (36-48 hours by video recording)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Intradialytic Pedalling Exercise and Vascular Hemodynamic Parameters Among Prevalent Hemodialysis Population
Brief Summary: The purpose of this pilot study is to evaluate 1) the effect of intradialytic pedaling exercise on arterial stiffness and other arterial hemodynamic parameters over 4 months, and 2) the longer-term effect of pedaling on arterial stiffness and other arterial hemodynamic parameters 4 months after finishing the exercise intervention (8 months after study initiation).

The investigators also aim to examine the impact of intradialytic pedaling exercise on general health, anthropometric measures, physical function, and routine laboratory blood markers as secondary outcome measures, as well as to assess feasibility, safety and adverse events associated with the intradialytic pedalling exercise.

Recruitment of more participants in the future will be considered if warranted.


Options:
A: Physical Activity (Baseline and 12 weeks)
B: The composite risk score (at entry and after 10 months)
C: Quantify toxin removal (6 months)
D: Change in non-invasive measures of arterial stiffness using applanation tonometry. (4 months and 8 months after study initiation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-week Open-label (Sponsor-blind), Randomized, Active-controlled, Parallel-group, Multi-center Study to Evaluate the Efficacy and Safety of Daprodustat Compared to Recombinant Human Erythropoietin in Subjects With Anemia Associated With Chronic Kidney Disease Who Are Initiating Dialysis
Brief Summary: The purpose of this multi-center study is to evaluate the efficacy and safety of daprodustat in subjects with anemia associated with CKD.


Options:
A: Rate of rise in hemoglobin (g/dL/week) (Baseline and at Week-6)
B: Percentage of Participants With a Hemoglobin (Hb) Response to Treatment at Two Consecutive Visits During the First 24 Weeks of Treatment Without Rescue Therapy Prior to Hb Response (Baseline to week 24); Hb Change From Baseline (BL) to the Average Hb in Weeks 28-52 Regardless of Rescue Therapy (Baseline and weeks 28 to 52)
C: Mean Change From Baseline in Hemoglobin (Hgb) During Evaluation Period (Week 28 to Week 52) (Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52))
D: Hemoglobin maintenance using FG-4592 dosing regimen in ESRD subjects. Number of subjects who hemoglobin levels are maintained at no lower than 0.5 g/dL below their mean baseline value during weeks 6 and 7. (Week 7)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-label Study to Evaluate the Effect of Daprodustat on Blood Pressure in Subjects With Anemia Associated With Chronic Kidney Disease on Hemodialysis Switched From a Stable Dose of an Erythropoiesis-stimulating Agent
Brief Summary: This will be an open-label, randomized, parallel-group study in hemodialysis-dependent (HD) participants with anemia associated with chronic kidney disease (CKD), designed to compare the effects of daprodustat to epoetin alfa on blood pressure (BP). Participants will be screened for eligibility within 7 and 30 days prior to erythropoesis-stimulating agent (ESA) washout. Following a 2-week ESA washout period, on Day 1 participants will be randomized 1:1 and stratified by prior ESA dose before they undergo Acute Challenge 1, a single dose challenge to compare the acute effects on BP of the highest planned once-daily maintenance dose of daprodustat (24 milligrams \[mg\]) to the highest starting dose of epoetin alfa (100 units/kilogram \[U/kg\]). This will be followed by an 8-week hemoglobin (Hgb)-maintenance period, where doses of either daprodustat or epoetin alfa will be administered and adjusted. At the end of Hgb maintenance period, on Day 57 an Acute Challenge 2 will be repeated utilizing the same treatment dose administered in Acute Challenge 1; there will be a follow-up visit within 14+/-3 days after completing treatment.


Options:
A: Average of Systolic Blood Pressure (SBP) Measured by Ambulatory Blood Pressure Monitoring (ABPM) Over 6-hour Post Dosing on Day 57 (Up to 6 hours post dose on Day 57)
B: Change in FBF Ratio in Response to Acetylcholine (Day 1 to Day 42) (Day 1 to Day 42)
C: Number of Participants With Week 7 Hb ≥ Baseline Hb - 0.5 g/dL, Among Normoresponder Participants Treated for 6 Weeks Only (Week 7); Number of Participants With Week 7 Hb ≥ Baseline Hb - 0.5 g/dL, Among Hyporesponsive Participants Treated for at Least 6 Weeks (Week 7); Number of Participants With a Mean Hb Above 11 g/dL When the Mean Hb Values at Weeks 17, 18, 19, and 20 Were Averaged, Among Participants Treated for 19 Weeks (Weeks 17, 18, 19, and 20)
D: Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period (Baseline and weeks 14 to 17)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: ENGAGED 2 Study: Experiences With Mammography Screening and Breast Density 2
Brief Summary: This trial will test a decision support web based intervention for women at increased risk for breast cancer due to breast density and other risk factors (age, race/ethnicity, family history of breast cancer, history of prior breast biopsies), and to consider MRI and/or chemoprevention to manage their breast cancer risk.


Options:
A: Glycosylated Hemoglobin (HbA1c): (baseline and at the end of 12 months post index date)
B: Percentage uptake of PPIUD (Within approximately 24 hours postpartum, before discharge from the hospital.)
C: Uptake of chemoprevention gathered via health plan pharmacy records at 12 months (12 months)
D: Definitive surgery choice as measured by self-reported and medical record verification at 6 months after randomization (1, 6, and 12 months); Quality of life as measured by functional assessment of cancer therapy for breast cancer (FACT-B) at 1, 6, and 12 months after randomization (1, 6, and 12 months); Distress as measured by Impact of Events Scale Brief Symptom Inventory at 1, 6, and 12 months after randomization (1, 6, and 12 months); Knowledge as assessed by Genetic Testing Knowledge Measure at 1 month after randomization (1 month); Decision outcomes as assessed by Decisional Conflict Scale Satisfaction with Decision Scale at 1 and 6 months after randomization (1 and 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1, Randomized, Double Blind, Placebo Controlled, Dose Escalation, and Bioavailability Study Evaluating the Safety and Pharmacokinetics of VX-659 in Healthy Subjects and in Subjects With Cystic Fibrosis
Brief Summary: Evaluate the safety and tolerability of VX-659 in healthy subjects


Options:
A: Safety and Tolerability (Over 7 treatment days and 7 days of follow-up)
B: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
C: Safety and Tolerability assessments as determined by number of subjects with adverse events (AEs) and serious adverse events (SAEs) (from baseline up to Day 50)
D: Absolute Change From Baseline in Percent-predicted Forced Expiratory Volume in One Second (ppFEV1) at Week 48 (From Baseline to Week 48)

Answer: C