TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Does the Wording of Text Message Reminders Improve Uptake in Breast Screening? A Randomised Controlled Trial
Brief Summary: Breast screening is a service offered by the NHS to help detect breast cancer and precancerous changes early at a time when treatment is more likely to be curative. An effective service must reach the 'at risk' but asymptomatic population. Breast screening uptake in London, consistently falls below the national target and is well below the national average. Uptake in West London is particularly low, with boroughs in Inner North West London having the some of lowest uptake rates in the country.

Routine text message reminders have proven effective at improving uptake of breast screening appointments. However little attention is paid to the content of the messages. Previous studies of text message reminders in other clinical areas have shown that the content of these messages matters and some text messages are more effective than others.

This protocol describes the design of a randomized controlled trial to investigate the effect of differently worded text messages on the engagement with breast screening in West London.

Two intervention arms were designed taking into consideration results of a 1000 woman survey to highlight the behavioural barriers that most predict attendance. The survey tested 15 behavioural constructs and the two that most strongly predicted history of attendance were used to inform the text message content of the intervention arms for this trial.

To this end, this randomised controlled trial (RCT) will test the current standard practice text message reminder against two intervention text message trial arms informed by the above described survey.

The setting is West of London Breast Screening Service and women aged 47-73 who are due for screening will be randomized to receive one of the three trial arms.

The primary outcome is the difference in uptake between trial arms. Further statistical analysis will analyse the difference in uptake by age group, deprivation score and previous attendance status.

Result will inform how small changes to the word content may have significant effects on attendance at screening mammogram appointments.


Options:
A: Proportion of Patients Who Receive a Pap Test at End of Follow up (18 months)
B: Use of long acting and reversible contraceptive at 4 months (4 months)
C: Percentage of Women With Triage Pap Smears at 120 Days After HPV Results (120 days)
D: Uptake of the timed appointment provided by the screening service (Usually within a month (Individual timed appointment is provided by the screening service))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Novel Worksite Smoking Cessation Intervention for Hispanic Construction Workers
Brief Summary: Construction workers have the highest rate of smoking among all occupations, and are frequently exposed to a wide range of workplace hazards (e.g. toxins), which interact with smoking to increase their health risks. Minority construction workers, in particular, have higher smoking and lower cessation rates compared to other groups, and they generally show lower access and participation in cessation and health promotion services. The number of Hispanic workers employed in the construction industry in the US has tripled in the past decade to 2.6 million (23% of all construction workers). This study will develop, administer, and evaluate a novel smoking cessation program in a hard-to-reach and underserved population of Hispanic male construction workers using using pilot cluster randomized clinical trial (RCT) to test the developed intervention for feasibility and potential efficacy.


Options:
A: Smoking Cessation: 7 Day Point Prevalence Abstinence (6 months); Continuous Abstinence From Smoking Since Discharge (6 months); Time to Smoking Relapse (6 months); Time to Smoking Lapse (6 months)
B: Prolonged Abstinence Rates (6-month)
C: Three month point-prevalence abstinence from cigarettes (3 months post-intervention)
D: Participants Abstinent From Cigarettes (Two years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-masked, Randomized, Placebo-controlled Study of the Nocturnal and Diurnal IOP-lowering Effect of Netarsudil Ophthalmic Solution 0.02% in Habitual Positions Over a 24-hour Period.
Brief Summary: To evaluate effect of Netarsudil Ophthalmic Solution 0.02% on Nocturnal and Diurnal Intraocular Pressure.


Options:
A: Intraocular Pressure (IOP) (29 Days)
B: Intraocular Pressure (IOP) (3 months)
C: Intraocular Pressure (IOP) (Primary efficacy endpoint measured for 3 months (data collected at 08:00, 10:00 and 16:00 hours at Day 15, Day 43 and Day 90))
D: Change in Intraocular Pressure (IOP) Over Nocturnal Time Period (Assessed over 24 hours at 9 pm, midnight, 3 am and 6 am on days 1/2 and 8/9)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study of the Effect of Lumacaftor/Ivacaftor Combination Therapy on Exercise Tolerance in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
Brief Summary: This is a Phase 4, randomized, double-blind, placebo-controlled, parallel-group study in subjects aged 12 years and older with CF who are homozygous for the F508del-CFTR mutation. This study is designed to evaluate the effect of LUM/IVA on exercise tolerance in subjects with CF, homozygous for the F508del-CFTR mutation.


Options:
A: The basis of analysis for the primary outcome measure will be the comparison of data from both the standard CF NPD protocol compared to a modified NPD protocol including the perfusion of Genistein. (All visits)
B: Relative (Percent) Change From Baseline in Maximal Oxygen Consumption (VO2max) During Cardiopulmonary Exercise Testing (CPET) at Week 24 (Baseline, Week 24)
C: Safety and Tolerability of N91115 (21 Days); Pharmacokinetics: Day 1 AUClast (Day 1); Pharmacokinetics: AUCtau Day 14 (Day 14); Pharmacokinetics: Day 1 Plasma Cmax Values (Day 1); Pharmacokinetics: Plasma Cmax Values on Day 14 (Day 14)
D: Absolute Change From Study Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Through Week 8 (Study Baseline, Through Week 8)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study of the Effect of Lumacaftor/Ivacaftor Combination Therapy on Exercise Tolerance in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
Brief Summary: This is a Phase 4, randomized, double-blind, placebo-controlled, parallel-group study in subjects aged 12 years and older with CF who are homozygous for the F508del-CFTR mutation. This study is designed to evaluate the effect of LUM/IVA on exercise tolerance in subjects with CF, homozygous for the F508del-CFTR mutation.


Options:
A: Change in sputum viscoelasticity (G*) over a broad frequency range (1-100 rad.s-1) (Baseline - immediately post exercise - 45min post exercise)
B: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 24 (Baseline, Week 16 and 24)
C: Relative (Percent) Change From Baseline in Maximal Oxygen Consumption (VO2max) During Cardiopulmonary Exercise Testing (CPET) at Week 24 (Baseline, Week 24)
D: Change in glucose tolerance (Measured at baseline, after 8 and 16 weeks.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Balanced Solution Versus Saline in Intensive Care Study
Brief Summary: A 2x2 factorial randomized study to evaluate the effect of a balanced crystalloid solution compared with 0.9% saline, and of rapid vs. slow infusion on clinical outcomes of critically ill patients


Options:
A: Mortality (90 days)
B: Proportion of Isotonic Crystalloid Which is 0.9% Saline (30 days)
C: Quality of Recovery-40 Score at 24 Hours (24 hours after ED visit)
D: Incidence of hyperchloremic acidosis during the 2 first days of acute cranial traumatism. (J1 and J2)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: DD-study: Diet or Diuretics for Salt-sensitivity in Chronic Kidney Disease
Brief Summary: In this clinical study the anti-hypertensive response to dietary salt restriction is compared with the anti-hypertensive response to the diuretics hydrochlorothiazide/amiloride in adult patients with chronic kidney disease.


Options:
A: 24-hourly urinary sodium excretion (up to 9 months)
B: 24 hour blood pressure (Two weeks after start of each intervention)
C: C-reactive protein (up to 16 weeks); interleukin-6 (up to 16 weeks); alpha tumor necrosis serum concetrations (up to 16 weeks)
D: Quality of life (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: DD-study: Diet or Diuretics for Salt-sensitivity in Chronic Kidney Disease
Brief Summary: In this clinical study the anti-hypertensive response to dietary salt restriction is compared with the anti-hypertensive response to the diuretics hydrochlorothiazide/amiloride in adult patients with chronic kidney disease.


Options:
A: 24 hour blood pressure (Two weeks after start of each intervention)
B: ∆Albuminuria by 24-hour Urine Protein Excretion (changes from week 8 at week 16 (week 8 - week 16))
C: Time Specific Interdialytic Weight Gain (Baseline) (Baseline); Time Specific Interdialytic Weight Gain (8 Weeks) (8 weeks); Time Specific Interdialytic Weight Gain (12 Weeks) (12 weeks); Time Specific Interdialytic Weight Gain (16 Weeks) (16 weeks); Time Specific Dietary Sodium Intake (Baseline) (Baseline); Time Specific Dietary Sodium Intake (8 Weeks) (8 weeks); Time Specific Dietary Sodium Intake (16 Weeks) (16 weeks); Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 8 Weeks) (Baseline to 8 weeks); Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 16 Weeks) (Baseline to 16 weeks)
D: Mean systematic blood pressure level (October 2010 - December 2012); 24 hour urinary sodium (October -December 2012)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessing the Risk of Wrong-Patient Errors in an Electronic Health Record That Allows Multiple Records Open
Brief Summary: This study is designed to achieve the following aims:

1. Assess the relationship between the number of records open at the time of placing an order, and the risk of placing an order on the wrong patient.
2. Compare the incidence of wrong-patient orders in a "restricted environment" that limits its providers to only one record open at a time to an "unrestricted environment" where users can open a maximum of four records at once.
3. The results of this study will help inform decisions on how to safely implement EHR systems.
4. The results of this study will inform a larger scale health IT implementation research project evaluating the balance between the wrong-patient error risks and potential efficiency gains of having multiple records open at once, with rigorous research methodologies.


Options:
A: N/A
B: Number of patients with at least one preventable medication error (Day 1 (medical prescription at hospital admission)); Number of patients with at least one preventable medication error (Phase 2 (maximum 105 days))
C: Wrong-patient Order Sessions, Defined as Order Sessions That Include at Least One Wrong-Patient Retract-and-Reorder (RAR) Event, As-randomized Analysis (19-month study period. All order sessions placed by randomized clinicians during the study period were included in the analysis. The time frame for each participant varied.)
D: Mean Severity-weighted Admission Medication History (AMH) Error Score (Attempted to obtain the day after admission)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Randomized, Open-label (Sponsor-blind), Active-controlled, Parallel-group, Multi-center, Event Driven Study in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease to Evaluate the Safety and Efficacy of Daprodustat Compared to Darbepoetin Alfa
Brief Summary: The purpose of this multi-center event-driven study in non-dialysis (ND) participants with anemia associated with chronic kidney disease (CKD) is to evaluate the safety and efficacy of daprodustat compared to darbepoetin alfa.


Options:
A: Change in FBF Ratio in Response to Acetylcholine (Day 1 to Day 42) (Day 1 to Day 42)
B: Change from baseline in the average Hemoglobin (Hb) (Baseline and Weeks 18 to 24)
C: 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)
D: Time to First Occurrence of Adjudicated Major Adverse Cardiovascular Event (MACE) During Cardiovascular (CV) Events Follow-up Time Period (Non-inferiority Analysis) (Up to 4.3 person-years for CV follow-up time period); Mean Change From Baseline in Hgb Levels Over the Evaluation Period (Week 28 to Week 52) (Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Evaluation of the Summer Electronic Benefits for Children Demonstration
Brief Summary: The Summer Electronic Benefit for Children (SEBTC) demonstration provided food assistance to households with school-aged children during the summer through electronic benefit transfer (EBT) procedures used by the Supplemental Nutrition Assistance Program (SNAP) and Special Supplemental Nutrition Program for Women, Infants and Children (WIC) programs. The evaluation design included two components: an impact study and an implementation study. The evaluation assessed the impact of SEBTC on children's food security and nutritional status, household food expenditures and purchasing behaviors, parental perceptions, and participation in nutrition assistance programs. The implementation study analyzed SEBTC use patterns using administrative data, and described demonstration implementation and costs.


Options:
A: 1-year, and 3-year changes from baseline in questionaires scores for knowledge, attitudes, and habits of children, parents and teachers in regards to a healthy lifestyle. (3 years)
B: Number of parents engaging with the HENRY programme measured using Centre level process data (12 month post randomisation (allowing 3 months for Optimisation intervention implementation and collecting data from 1- 2 HENRY courses per site).)
C: Very low food security among children according to the U.S. Household Food Security Survey Module, 30-day reference period (Between 30 and 120 days after SEBTC benefits were issued)
D: Change in mother daily fruit and vegetable intake in the past month between baseline, immediate-post intervention and 6-months post-intervention, assessed using the NCI Fruit and Vegetable All-Day Screener (Baseline, 4 months, 10 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Evaluation of the Summer Electronic Benefits for Children Demonstration
Brief Summary: The Summer Electronic Benefit for Children (SEBTC) demonstration provided food assistance to households with school-aged children during the summer through electronic benefit transfer (EBT) procedures used by the Supplemental Nutrition Assistance Program (SNAP) and Special Supplemental Nutrition Program for Women, Infants and Children (WIC) programs. The evaluation design included two components: an impact study and an implementation study. The evaluation assessed the impact of SEBTC on children's food security and nutritional status, household food expenditures and purchasing behaviors, parental perceptions, and participation in nutrition assistance programs. The implementation study analyzed SEBTC use patterns using administrative data, and described demonstration implementation and costs.


Options:
A: Change in Observed Child Dietary Intake (8 Months); Change in Measured Child Physical Activity in Child Care (8 months); Change in Observed Child Dietary Intake (12 Months); Change in Measured Child Physical Activity in Child Care (12 Months)
B: Change of BMI Z-score for preschoolers (Baseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-up)
C: Change from baseline in energy dense food consumption at 12 months (12 months); Change from baseline in nutrient dense food consumption at 12 months (12 months)
D: Very low food security among children according to the U.S. Household Food Security Survey Module, 30-day reference period (Between 30 and 120 days after SEBTC benefits were issued)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2b Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants
Brief Summary: The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy preterm infants who are between 29 and 35 weeks gestational age (GA) and entering their first Respiratory Syncytial Virus (RSV) season.


Options:
A: Incidence of medically significant RSV LRTI with either hypoxemia (SpO2 <95% at sea level or <92% at altitudes >1800 meters) or tachypnea in infants through 90 days of life (Delivery to 90 days after delivery)
B: Number of Participants With Medically Attended Respiratory Syncytial Virus (RSV) Confirmed Lower Respiratory Tract Infection (LRTI) (From Day 1 through Day 151)
C: Cumulative incidence of recurrent wheezing confirmed by physicians (two years)
D: Number of Subjects Reporting Serious Adverse Events (SAEs) (Day 0 - Day 150); Number of Subjects Reporting Adverse Events (AEs) (Day 0 - Day 150); Number of Subjects With Changes in Laboratory Chemistry Values Reported as AEs. (Day 0 - Day 150)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Vascular Effects of Regular Cigarettes Versus electronIc Cigarette Use
Brief Summary: The purpose of this study is to assess the effects of electronic cigarettes-nicotine and electronic cigarette-nicotine free on endothelial function as compared to traditional cigarettes. Due to ethical reasons, we cannot fully randomise all particpants to the three arms.

Participants who wish to quit smoking will be randomized to

1. Switch to electronic cigarettes containing nicotine plus flavor
2. Switch to electronic cigarettes containing flavor alone Those who do not wish to quit smoking will continue on the Tobacco Cigarette arm Treatment period will be 28 days


Options:
A: The primary outcome will be the biochemically confirmed (exhaled CO < 10 ppm) self-reported continuous abstinence for weeks 12 to 26. (26 weeks)
B: Change in Flow mediated Dilation (FMD) between the TC group and the EC-nicotine and EC-nicotine free groups (Baseline and 1 month)
C: Amount of Tobacco Product Used (6 weeks)
D: Cotinine Level (Baseline, 4 weeks, 8 weeks); Change From Baseline in Cognitive Performance (basline and 8 weeks (or end of study iif patient ended participation before the 8-weeks))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Vascular Effects of Regular Cigarettes Versus electronIc Cigarette Use
Brief Summary: The purpose of this study is to assess the effects of electronic cigarettes-nicotine and electronic cigarette-nicotine free on endothelial function as compared to traditional cigarettes. Due to ethical reasons, we cannot fully randomise all particpants to the three arms.

Participants who wish to quit smoking will be randomized to

1. Switch to electronic cigarettes containing nicotine plus flavor
2. Switch to electronic cigarettes containing flavor alone Those who do not wish to quit smoking will continue on the Tobacco Cigarette arm Treatment period will be 28 days


Options:
A: Number of Participants With Smoking Cessation (12 WEEK)
B: urine carcinogen biomarker of exposure, NNAL (week 24)
C: smoking status (baseline, 3, 6, 12, and 18 months follow-up); commitment to abstinence (baseline, 3, 6, 12, and 18 months); quit attempts (3, 6, 12, and 18 months follow-up)
D: Change in Flow mediated Dilation (FMD) between the TC group and the EC-nicotine and EC-nicotine free groups (Baseline and 1 month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Vascular Effects of Regular Cigarettes Versus electronIc Cigarette Use
Brief Summary: The purpose of this study is to assess the effects of electronic cigarettes-nicotine and electronic cigarette-nicotine free on endothelial function as compared to traditional cigarettes. Due to ethical reasons, we cannot fully randomise all particpants to the three arms.

Participants who wish to quit smoking will be randomized to

1. Switch to electronic cigarettes containing nicotine plus flavor
2. Switch to electronic cigarettes containing flavor alone Those who do not wish to quit smoking will continue on the Tobacco Cigarette arm Treatment period will be 28 days


Options:
A: Change in Flow mediated Dilation (FMD) between the TC group and the EC-nicotine and EC-nicotine free groups (Baseline and 1 month)
B: Smoking abstinence at 6 months after inclusion (yes/no) (6 months after inclusion)
C: 7 Day Point Prevalence Abstinence From All Forms of Tobacco (4 weeks after beginning study)
D: Rate of Smoking Abstinence (18 months & 24 months post study enrollment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Vascular Effects of Regular Cigarettes Versus electronIc Cigarette Use
Brief Summary: The purpose of this study is to assess the effects of electronic cigarettes-nicotine and electronic cigarette-nicotine free on endothelial function as compared to traditional cigarettes. Due to ethical reasons, we cannot fully randomise all particpants to the three arms.

Participants who wish to quit smoking will be randomized to

1. Switch to electronic cigarettes containing nicotine plus flavor
2. Switch to electronic cigarettes containing flavor alone Those who do not wish to quit smoking will continue on the Tobacco Cigarette arm Treatment period will be 28 days


Options:
A: Change in Biomarker Concentrations: Nicotine Equivalents (Baseline, Week 6); Change in Biomarker Concentrations: NNAL (Baseline, Week 6)
B: smoking cessation (52 weeks)
C: Rate of Smoking Abstinence (18 months & 24 months post study enrollment)
D: Change in Flow mediated Dilation (FMD) between the TC group and the EC-nicotine and EC-nicotine free groups (Baseline and 1 month)

Answer: D