TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I Study of the Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine RSV ΔNS2 Δ1313 I1314L, Lot RSV#006A, Delivered as Nose Drops to RSV-Seropositive Children 12 to 59 Months of Age, RSV-Seronegative Infants and Children 6 to 24 Months of Age, and Infants 4 to 6 Months of Age
Brief Summary: Human respiratory syncytial virus (RSV) is a common cause of respiratory illness in infants and children around the world. This study will evaluate the safety and immune response to a RSV vaccine in three groups of participants: healthy children who have already had an RSV infection (RSV seropositive), healthy infants and children who have not already had an RSV infection (RSV seronegative), and healthy younger infants who have not been screened for prior RSV infection.


Options:
A: Frequency of vaccine-related reaction events and other adverse events in each cohort (Throughout study); Amount of vaccine virus shed by each participant (Throughout study); Amount of serum antibody and mucosal antibody induced by the vaccine in each participant (Throughout study)
B: Incidence of Skin and Soft Tissue Infection (SSTI) (At the end of the 20 month study); Incidence of Methicillin-resistant Staphylococcus Aureus (MRSA)-Associated SSTI (At the end of the 20 month study)
C: Percentage of Participants With Solicited Symptoms (Day 1 to Day 7); Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) (From Day 1 to Day 29); Percentage of Participants With Treatment-emergent Serious Adverse Events (From Day 1 to Day 361); Percentage of Participants With New Onset Chronic Diseases (NOCDs) (From Day 1 to Day 361); Percentage of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESI) (From Day 1 to Day 361)
D: Frequency and severity of vaccine-related solicited adverse events (AEs) that occur during the intensive monitoring phase of the study (Measured at Days 0-10 for seropositive children and Days 0-28 for seronegative infants and children); Proportion of participants that develop 4-fold or greater rises in RSV neutralizing antibody titer following vaccination (Measured through follow-up period, up to 1 year after study entry)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Cluster Randomized Trial of the Implementation of the NHLBI Expert Panel Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents
Brief Summary: This is a cluster randomized trial of pediatric cardiovascular risk reduction guideline implementation in 32 clinical practices


Options:
A: Change in percentage overweight (Baseline, Week 12 (post-intervention), Week 24)
B: Body Mass Index score(BMI sds) at the age 6 years to monitor the effectiveness of the intervention (5 years)
C: Motor skills (1 school year)
D: Summary composite measure of practice performance and exposure (One year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Primary Care Internet Based Depression Prevention for Adolescents (Promoting AdolescenT Health-PATH)
Brief Summary: The purpose of this randomized multiple-site clinical study is to determine whether a revised CATCH-IT (Internet-based depression prevention program) is more effective than a general health education Internet intervention (Health Education)on teens ages 13-18 (inclusive). It is hypothesized that teens in CATCH-IT will exhibit lower levels of depressed mood and/or maintain lower depressive scores over 2 years long-term follow up as compared to teens in Health Education group.


Options:
A: Major Depressive Episode (major and sub-threshold) (0, 2, 6, 12, 18 and 24 months)
B: Presence or absence of a depressive episode (child) (T4 (9 months after completion of the programme))
C: use of Internet site (2 months)
D: Depressive symptoms (Pre-, post-monitoring, 6-week follow up & 6 month follow-up); Emotional Self Awareness (Pre-, post-, 6-weeks post- and 6-months post-test)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Discharge Planning for Older Adults in the Emergency Department: Use of a Brief Phone Call After Discharge to Decrease Return Visits to the Emergency Department and Re-admissions to the Hospital
Brief Summary: The purpose of this study is to determine whether a phone call from a nurse within 1-3 days after discharge from the Emergency Department (ED) decreases return visits to the ED/ hospital admissions/ death (combined outcome) in patients age 65 and above. As secondary outcomes, time to follow up appointment with physician and economic impact of this intervention will be assessed.

Patients 65 years of age and older will be randomized following discharge from the ED into one of two groups. Group 1(Intervention) will receive a phone call collecting information about understanding of ED discharge instructions and guiding patient through the discharge instructions, and Group 2 (Placebo) will receive a follow up phone call for a satisfaction survey.

We hypothesize return visits to the ED and readmission to the hospital will decrease as a result of the nurse phone call intervention.


Options:
A: Re-hospitalization (90 days)
B: HbA1c (12month); Blood pressure (12 month); Lipid profile (12 months); quality of life (12month)
C: Time to the first occurrence of hospital readmission, emergency department visit, or death. (0-35 days)
D: Safety: All-cause mortality (6 weeks); Safety: Readmission for any of CHF, unstable angina, arrhythmia, re-infarction, revascularization, stroke, or major bleeding requiring transfusion (6 weeks); Feasibility: Proportion of patients in the intervention group discharged within 72 hours ("feasible" if >= 70%); Feasibility: Proportion of patients in the intervention group who saw nurse practitioner within 3 days of discharge ("feasible" if >= 80%); Feasibility: Proportion of patients in the intervention group who saw nurse practitioner within 5 days of discharge ("feasible" if >= 90%)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of an Intensive Lifestyle Intervention on Reproductive Outcomes in Obese, Subfertile Women
Brief Summary: This is a study to determine whether a low calorie diet using meal replacement shakes compared to current counseling about diet, followed by 3 cycles of clomiphene citrate (if needed) will result in: 1) improvements in ability to ovulate and achieve pregnancy either spontaneously or during 3 clomiphene citrate cycles 2) greater weight loss with reductions in waist and hip circumferences and improvements in hormones that are involved in allowing pregnancy to occur and hormones that are involved in metabolism, such as insulin and glucose (sugar) 3) improvements in other health conditions such as blood pressure, and emotional and physical well-being.

Women eligible to participate will be between the ages of 18-35 with a BMI (ratio of weight in kg divided by height in m2) of ≥ 35≤45 kg/m2 who are seeking help for anovulatory infertility including women with a diagnosis of polycystic ovarian syndrome (PCOS).


Options:
A: Improvement in ovulatory cycling (24 months)
B: Laboratory pregnancy, live pregnancy at 12 weeks, take home baby rate (4 weeks to 9 month)
C: Cumulative ongoing pregnancy rate (COPR) within 12 months after randomisation (12 months)
D: Clinical Pregnancy Rates (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of an Intensive Lifestyle Intervention on Reproductive Outcomes in Obese, Subfertile Women
Brief Summary: This is a study to determine whether a low calorie diet using meal replacement shakes compared to current counseling about diet, followed by 3 cycles of clomiphene citrate (if needed) will result in: 1) improvements in ability to ovulate and achieve pregnancy either spontaneously or during 3 clomiphene citrate cycles 2) greater weight loss with reductions in waist and hip circumferences and improvements in hormones that are involved in allowing pregnancy to occur and hormones that are involved in metabolism, such as insulin and glucose (sugar) 3) improvements in other health conditions such as blood pressure, and emotional and physical well-being.

Women eligible to participate will be between the ages of 18-35 with a BMI (ratio of weight in kg divided by height in m2) of ≥ 35≤45 kg/m2 who are seeking help for anovulatory infertility including women with a diagnosis of polycystic ovarian syndrome (PCOS).


Options:
A: Improvement in ovulatory cycling (24 months)
B: Clinical Pregnancy Rate (up to 18 weeks - in average, two weeks after the end of the in vitro fertilization cycle)
C: The main outcome was change in body weight. (Patient's body weight was measured at the base point and after 12 weeks of clinical trial.)
D: Clinical pregnancy (within 6 calendar months of randomisation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Brief Prescription Opioid Overdose Intervention in an Emergency Department
Brief Summary: Unintentional poisoning is a developing public health problem in the U.S. Unintentional poisoning (or "overdose") deaths increased 157% among adults between 1999 and 2008. There were \~700,000 emergency department (ED) visits due to overdoses in 2007. Medication-related overdoses, particularly prescription opioid overdoses, have accounted for much of this increase. There have been parallel increases in sales of opioids (with a 6 fold increase between 1997 and 2007), as well as both medical and non-medical use of prescription opioids. Prescription opioids are now among the most common of drugs used non-medically in the U.S.

The specific aims of this project are to: 1) Develop an ED-based tailored brief prescription opioid overdose prevention intervention. We will examine therapeutic alliance, perceived satisfaction, and perceived utility of the intervention; 2) Examine intervention effects on precursors of overdose risk behavioral change immediately post-intervention. We will compare intervention and control participants on knowledge, self-efficacy, readiness to change, and behavioral intentions regarding overdose risk behavior; and 3) Examine intervention effects on overdose risk behaviors six months post-intervention. We will compare intervention and control participants on: 1) use of high dose/quantity of opioids; 2) using opioids in combinations with certain psychoactive substances (i.e., alcohol, heroin, cocaine, and sedatives); and, 3) route of administration.


Options:
A: Proportion of Risky Drinkers Measured by AUDIT-C (6 weeks); Proportion of Patients Attending to Specialized Treatment (6 weeks)
B: Days of Primary Substance Use (4 weeks post randomization); Number of Substance-related problems (4 weeks post randomization); Times engaging in risky behaviors (4 weeks post randomization); Days of Substance Use Treatment (4 weeks post randomization); ART Medication Adherence (4 weeks post randomization)
C: alcohol use (6 months); HIV risk taking (6 months)
D: Overdose Risk Behavior (6 months post-baseline); Overdose Knowledge (6 months post-baseline); Behavioral Intentions (6 months post-baseline)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Mobile Phone One Way Short Message Service (SMS) Versus SMS Dialogue for Women's and Child Health (Mobile WACh) in Kenya: A Randomized Control Trial
Brief Summary: With the increased prevalence of cellular phones, mobile technology provides an important tool to reach underserved populations in low to middle income countries. mHealth interventions offer promise to improve maternal child health throughout the reproductive health continuum if they contribute to increasing skilled birth attendance, family planning and exclusive breastfeeding. We propose a randomized clinical trial to determine effect of using mobile phones to deliver SMS (one-way) versus an interactive SMS dialogue (two-way) on uptake of reproductive and neonatal health services and maternal and infant outcomes


Options:
A: Contraceptive uptake (10 weeks postpartum; 24 weeks postpartum); Facility Delivery (Postpartum); Exclusive Breastfeeding (24 weeks postpartum)
B: 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)
C: ANC (Assess the recommend number of ANC (4 ANC) coverage 18 months after intervention); PNC (Assess the recommend number of PNC (3 ANC) coverage 18 months after intervention); Contraceptive prevalence rate (CPR) (Assess the Contraceptive prevalence rate (CPR) at the end of intervention of 18 months.); EPI coverage (Assess the EPI vaccination coverage at the end of the intervention of 18 months)
D: Highly-effective contraceptive use (6 months postpartum)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Mobile Phone One Way Short Message Service (SMS) Versus SMS Dialogue for Women's and Child Health (Mobile WACh) in Kenya: A Randomized Control Trial
Brief Summary: With the increased prevalence of cellular phones, mobile technology provides an important tool to reach underserved populations in low to middle income countries. mHealth interventions offer promise to improve maternal child health throughout the reproductive health continuum if they contribute to increasing skilled birth attendance, family planning and exclusive breastfeeding. We propose a randomized clinical trial to determine effect of using mobile phones to deliver SMS (one-way) versus an interactive SMS dialogue (two-way) on uptake of reproductive and neonatal health services and maternal and infant outcomes


Options:
A: Intention to treat analysis (13 months)
B: Vaccines received (Electronic Health Record) (up to a year of follow up)
C: HIV self-testing-Number of participants who request an HIV self-testing kit (Measured during the intervention)
D: Contraceptive uptake (10 weeks postpartum; 24 weeks postpartum); Facility Delivery (Postpartum); Exclusive Breastfeeding (24 weeks postpartum)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Mobile Phone One Way Short Message Service (SMS) Versus SMS Dialogue for Women's and Child Health (Mobile WACh) in Kenya: A Randomized Control Trial
Brief Summary: With the increased prevalence of cellular phones, mobile technology provides an important tool to reach underserved populations in low to middle income countries. mHealth interventions offer promise to improve maternal child health throughout the reproductive health continuum if they contribute to increasing skilled birth attendance, family planning and exclusive breastfeeding. We propose a randomized clinical trial to determine effect of using mobile phones to deliver SMS (one-way) versus an interactive SMS dialogue (two-way) on uptake of reproductive and neonatal health services and maternal and infant outcomes


Options:
A: Smoking Abstinence (3 months)
B: Proportion of men failing to return for a post-operative clinic visit at 7 days. (7 days); Proportion of men who report resumption of sexual activity before 42 days post-circumcision. (42 days)
C: Contraceptive uptake (10 weeks postpartum; 24 weeks postpartum); Facility Delivery (Postpartum); Exclusive Breastfeeding (24 weeks postpartum)
D: Prevalence of Influenza Vaccination of those who do receive text message reminders compared to those who do not. (Up to 5 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Mobile Phone One Way Short Message Service (SMS) Versus SMS Dialogue for Women's and Child Health (Mobile WACh) in Kenya: A Randomized Control Trial
Brief Summary: With the increased prevalence of cellular phones, mobile technology provides an important tool to reach underserved populations in low to middle income countries. mHealth interventions offer promise to improve maternal child health throughout the reproductive health continuum if they contribute to increasing skilled birth attendance, family planning and exclusive breastfeeding. We propose a randomized clinical trial to determine effect of using mobile phones to deliver SMS (one-way) versus an interactive SMS dialogue (two-way) on uptake of reproductive and neonatal health services and maternal and infant outcomes


Options:
A: Proportion of fully immunized children (When the participants reach 2 years of age)
B: To assess the effectiveness of SMS reminders on cell phones in improving the compliance of subsequent visits for routine immunization for children in Pakistan (10 Months)
C: Highly-effective contraceptive use (6 months postpartum)
D: Contraceptive uptake (10 weeks postpartum; 24 weeks postpartum); Facility Delivery (Postpartum); Exclusive Breastfeeding (24 weeks postpartum)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Mobile Phone One Way Short Message Service (SMS) Versus SMS Dialogue for Women's and Child Health (Mobile WACh) in Kenya: A Randomized Control Trial
Brief Summary: With the increased prevalence of cellular phones, mobile technology provides an important tool to reach underserved populations in low to middle income countries. mHealth interventions offer promise to improve maternal child health throughout the reproductive health continuum if they contribute to increasing skilled birth attendance, family planning and exclusive breastfeeding. We propose a randomized clinical trial to determine effect of using mobile phones to deliver SMS (one-way) versus an interactive SMS dialogue (two-way) on uptake of reproductive and neonatal health services and maternal and infant outcomes


Options:
A: Contraceptive uptake (10 weeks postpartum; 24 weeks postpartum); Facility Delivery (Postpartum); Exclusive Breastfeeding (24 weeks postpartum)
B: Proportion of fully immunized children (When the participants reach 2 years of age)
C: 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)
D: Vaccines received (Electronic Health Record) (up to a year of follow up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open Label, Randomised, Four-Period Crossover, Single Dose Study in Healthy Volunteers to Evaluate the Pharmacokinetics of FF/UMEC/VI Combination Administered at Dose Levels 100/62.5/25 mcg and 100/125/25 mcg and in Comparison With FF/VI (100/25 mcg) and UMEC/VI (62.5/25 mcg).
Brief Summary: This study will evaluate the pharmacokinetics of FF, UMEC and VI administered from one inhaler (at two different strengths of UMEC (125 and 62.5microgram \[mcg\]) and FF/VI (ICS/LABA) and UMEC/VI (LAMA/LABA).

Subjects will receive each of the four treatments once, separated by a wash-out period of 7-21 days between doses in a four way crossover design. There will be 4 treatment periods in total. During each treatment period, subjects will attend the clinical unit on Day -1 for standard safety assessments in addition to familiarization with the inhaler. Each subject will remain resident in the unit until at least 24 hours after the dose given on Day 1. Following completion of all four treatment periods, a follow up visit will take place 7 to 21 days following the final dose of study medication.


Options:
A: Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24) (Baseline and Day 169)
B: Cmax (5 months); tmax (5 months); tlast (5 months); AUC0-t (5 months); t1/2 (5 months); CL/F (5 months); Vd/F (5 months); AUC0-inf (5 months); AUC0-t' (5 months); C τ (5 months); AUC0-τ (5 months); Ro (5 months); RCmax (5 months); DF (5 months)
C: Composite of Pharmacokinetic (PK) Parameters as a measure of systemic exposure. (PK Blood samples will be collected at Predose, 3, 5, 7, 10, 15, 12, 15, 30, 45 minutes, 1hour, 1.5, 2, 4, 6, 8, 12, 24 hours post dose on Day 1 of each treatment period); Systemic exposure of FF and UMEC and VI following single inhaled doses (four inhalations) of FF/UMEC/VI 100mcg /62.5mcg /25mcg compared with FF/VI 100mcg /25mcg and UMEC/VI 62.5mcg /25mcg (PK Blood samples will be collected at Day 1 Predose, 3, 5, 7, 10, 15, 12, 15, 30, 45 minutes, 1hour, 1.5, 2, 4, 6, 8, 12, 24 hours post dose.)
D: General safety and tolerability endpoints: Adverse Events (AE), HR, BP, 12- lead ECG and lung function (FEV1) and clinical laboratory safety tests (Various)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The disparity between supply and demand for organs has stimulated the development of strategies to increase the availability of kidney grafts. Such strategy involves the use of kidneys with expanded donor criteria (EDC). This is a study initiated by the investigator, open, prospective, randomized, single center designed to compare the safety and efficacy of two immunosuppressive regimens based on thymoglobulin, tacrolimus and everolimus versus thymoglobulin, tacrolimus and mycophenolate sodium in renal transplant recipients with donor criteria expanded.


Options:
A: Number of Participants With Composite Efficacy Endpoints - 12 Month Analysis (12 months); Non-inferiority Analysis on Percentage of Participants With Composite Efficacy Endpoints (12 months)
B: Glomular Filtration Rate (GFR) mL/Min Via Nankivell Method at Month 12 - Standard Regimen vs Certican Regimens (One year post transplant)
C: Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2. (Month 12 is Primary, Month 24 secondary)
D: Incidence of CMV disease (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Time-Restricted Feeding to Improve Glucose Tolerance and Vascular Condition
Brief Summary: The purpose of this pilot study is to find out what eating meals in a short time period early in the day (time-restricted feeding) versus eating meals spread out during the day (grazing) does to the body's ability to control blood sugar and to the health of its blood vessels.

The investigators hypothesize that time-restricted feeding will be more effective at improving glucose tolerance and vascular condition (inflammation and micro- and macro-vascular function) than grazing.


Options:
A: Body weight (12 weeks)
B: Insulin Sensitivity (HOMA-IR) (4 weeks (from Baseline to 4 weeks)); Insulin Sensitivity (QUICKI) (4 weeks (from Baseline to 4 weeks)); Insulin Sensitivity (ISI-Index) (4 weeks (from Baseline to 4 weeks)); Insulin Sensitivity (Matsuda-Index) (4 weeks (from Baseline to 4 weeks))
C: Change in Glucose Tolerance (Before and after 5 weeks on each feeding schedule)
D: Endothelium Dependent Dilation (6 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A, Randomized Comparative, Open-Label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by High Single Dose In-fusions or Standard Medical Care in Women After Postpartum Haemorrhage
Brief Summary: The primary purpose of this study is to compare the efficacy of IV high single dose infusion of iron isomaltoside 1000 to standard medical care in women with PPH evaluated as physical fatigue.


Options:
A: Mortality at the 45th day (45 days)
B: Physical Fatigue (on day 3 postpartum)
C: Physical fatigue (From exposure to 12 weeks post-exposure)
D: Number of Subjects Who Achieved 'Success' Meaning a ≥ 2.0 Increase in Hemoglobin (anytime between baseline and the end of study or time to intervention)

Answer: C