TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Stroke Health and Risk Education (SHARE)
Brief Summary: Stroke is a disease with tremendous individual, family, and societal impact. It is the number one cause of adult disability and third leading cause of death in the United States. Between now and the year 2050, the cost of stroke in the United States will exceed 2 trillion dollars. There is a tremendous ethnic disparity with respect to stroke in the United States. Mexican Americans are much more likely to have a stroke compared with European Americans. In Mexican Americans strokes occur at younger ages, are more likely to recur and have the same severity as they do in European Americans. Mexican Americans are the overwhelming largest sub-population of Hispanic Americans, the nation's largest minority group. This proposal, a scientifically-based rigorous behavioral education intervention trial, seeks to aggressively prevent stroke, especially in Mexican Americans.

Faith and family are strong components of Mexican American culture. This project works with these positive fundamental elements in order to affect stroke prevention. This project will take place in Nueces County, Texas. The project investigators have worked in this community for the past 14 years and have published extensively regarding the stroke health disparity in this stable, non-immigrant community of Mexican Americans and European Americans. We have established a strong partnership with the Catholic Diocese of Corpus Christi and assembled a team with tremendous experience at successful health behavior intervention research. Together, a proposal has been crafted that will directly speak to aggressive stroke risk factor reduction in Mexican Americans and European Americans in this representative United States community.

The significance of such research is tremendous. As the Mexican American population grows and ages, the stroke impact will be felt with greater and greater intensity. Now is the time to develop aggressive, scientifically tested interventions to limit the burden of this disease on this important segment of the United States population, and to reduce the costs of this disease to the country as a whole, in keeping with the Government Performance and Results Act (GPRA) goal to "identify culturally appropriate, effective stroke prevention programs for nationwide implementation in minority communities" by FY2010.


Options:
A: Feasibility of Using Facebook and Text Messaging to Deliver a Physical Activity Program to African American Women (Post Intervention (up to 8 weeks))
B: Change in Fruit and Vegetable Intake (Baseline, 6 and 12 months); Change in Fruit and Vegetable Intake (Baseline, 6 and 12 months)
C: Primary outcome measure was step count (6-weeks)
D: Sodium intake (12 months); Fruit/vegetable intake (12 months); Physical activity (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Peritoneal Lavage With Clindamycin-gentamicin Solution on Infection in Elective Surgery
Brief Summary: Intrabdominal antibiotic irrigation will reduce wound and intrabdominal infection.


Options:
A: Surgical site infection (30 days)
B: Drainage volume (7 days)
C: The Number of Participants With Re-operations (All Subsequent Operative Procedures to Treat an Infection, a Wound Healing Problem, or a Nonunion). (one year)
D: Post-operative infection (6 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Peritoneal Lavage With Clindamycin-gentamicin Solution on Infection in Elective Surgery
Brief Summary: Intrabdominal antibiotic irrigation will reduce wound and intrabdominal infection.


Options:
A: Number of Participants With Surgical Wound Infections From Surgery Through Post-operative Day 60 (assessed at Postop Day 1, 2, 3, 7, 30 & 60)
B: Incidence of incisional surgical site infection (SSI)
C: Surgical site infection (30 days)
D: Surgical site infection following elective colorectal surgery based on surgical site assessment.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Smoking Cessation Treatment for Methadone Maintenance Patients
Brief Summary: This randomized trial will evaluate whether varenicline directly observed therapy provided at a methadone clinic is more efficacious than self-administered varenicline for promoting smoking cessation and enhancing adherence.


Options:
A: Summarization of safety data in smokers treated with either varenicline or placebo.
B: Varenicline Adherence as Measured by Pill Count (Weeks 0-1, 1-2, 2-3, 4-6, 7-9, 10-12)
C: The primary outcome will be measured at 5, 10, 22, and 52 weeks after the target quit date and include: CO confirmed continuous abstinence from 5-10 weeks, 5-22 weeks and 5-52 weeks. (5-10 weeks, 5-22 weeks, and 5-52 weeks post target quit date)
D: Continuous abstinence from smoking from week 9 to week 48 without the use of any other smoking cessation treatments other than trials' treatment (from week 9 to week 48)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Smoking Cessation Treatment for Methadone Maintenance Patients
Brief Summary: This randomized trial will evaluate whether varenicline directly observed therapy provided at a methadone clinic is more efficacious than self-administered varenicline for promoting smoking cessation and enhancing adherence.


Options:
A: Tobacco use (Six-month follow-up)
B: A significant percentage of surgical patients will be receptive to smoking cessation interventions in the preadmission clinic and will refrain from smoking at 24 and 52 weeks after starting the treatment. (2 years)
C: Varenicline Adherence as Measured by Pill Count (Weeks 0-1, 1-2, 2-3, 4-6, 7-9, 10-12)
D: Percentage of Participants With a Four-Week Continuous Quit Rate (CQR) (Week 9 through Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Smoking Cessation Treatment for Methadone Maintenance Patients
Brief Summary: This randomized trial will evaluate whether varenicline directly observed therapy provided at a methadone clinic is more efficacious than self-administered varenicline for promoting smoking cessation and enhancing adherence.


Options:
A: Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt) (weeks 9 through 12)
B: Varenicline Adherence as Measured by Pill Count (Weeks 0-1, 1-2, 2-3, 4-6, 7-9, 10-12)
C: Seven-day point prevalence smoking abstinence at end of trial (abstinence based on self-reported smoking abstinence verified by CO levels < 10 ppm) (9 weeks)
D: 7 Day Point Prevalence of Cigarette Abstinence (6-month follow up); 7 Day Point Prevalence of Cigarette Abstinence (Week 8)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Smoking Cessation Treatment for Methadone Maintenance Patients
Brief Summary: This randomized trial will evaluate whether varenicline directly observed therapy provided at a methadone clinic is more efficacious than self-administered varenicline for promoting smoking cessation and enhancing adherence.


Options:
A: 7-day Point Prevalence Smokeless Tobacco Abstinence Biochemically Confirmed With Urine Cotinine at the End of 12 Weeks of Treatment. (At the end of treatment (12 weeks))
B: Prolonged Smoking Abstinence at End of 12 Weeks of Varenicline Treatment (12 weeks)
C: Varenicline Adherence as Measured by Pill Count (Weeks 0-1, 1-2, 2-3, 4-6, 7-9, 10-12)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Smoking Cessation Treatment for Methadone Maintenance Patients
Brief Summary: This randomized trial will evaluate whether varenicline directly observed therapy provided at a methadone clinic is more efficacious than self-administered varenicline for promoting smoking cessation and enhancing adherence.


Options:
A: Safety (Baseline (week 0), Weeks 1-9, End of trial (Week 10)); Smoking cessation (End of trial (Week 10))
B: Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking (Week 15 - 24)
C: Number of Participants With a Quit Attempt (6 months)
D: Varenicline Adherence as Measured by Pill Count (Weeks 0-1, 1-2, 2-3, 4-6, 7-9, 10-12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Smoking Cessation Treatment for Methadone Maintenance Patients
Brief Summary: This randomized trial will evaluate whether varenicline directly observed therapy provided at a methadone clinic is more efficacious than self-administered varenicline for promoting smoking cessation and enhancing adherence.


Options:
A: Varenicline Adherence as Measured by Pill Count (Weeks 0-1, 1-2, 2-3, 4-6, 7-9, 10-12)
B: Emotional Reactivity By Pharmacotherapy (Baseline to 1 month); Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele (Baseline to 1 month)
C: Days of abstinence following the programmed lapse (7 days)
D: Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 12 (12 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 24 (24 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 52 (52 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 64 (64 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 104 (104 weeks following treatment initiation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Smoking Cessation Treatment for Methadone Maintenance Patients
Brief Summary: This randomized trial will evaluate whether varenicline directly observed therapy provided at a methadone clinic is more efficacious than self-administered varenicline for promoting smoking cessation and enhancing adherence.


Options:
A: Number of Participants With 4-week Continuous Abstinence (Weeks 9 through 12)
B: Varenicline Adherence as Measured by Pill Count (Weeks 0-1, 1-2, 2-3, 4-6, 7-9, 10-12)
C: 7-day Prevalence of Abstinence From Cigarette Smoking at 12 Weeks (12 weeks); 7 Day Prevalence of Abstinence From Cigarette Smoking at 24 Weeks (24 weeks)
D: 4 week continuous quit rate ( 4 week CQR ) for weeks 9 -12

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Smoking Cessation Treatment for Methadone Maintenance Patients
Brief Summary: This randomized trial will evaluate whether varenicline directly observed therapy provided at a methadone clinic is more efficacious than self-administered varenicline for promoting smoking cessation and enhancing adherence.


Options:
A: seven-day point prevalence of smoking reduction, defined as 50 % reduction in serum cotinine levels compared to baseline (end of treatment)
B: Seven-day point prevalence and treatment or treatment strategy (At week 6); Main effects of varenicline and nicotine patch + lozenge on smokers who remain on these medications throughout the trial as documented in questionnaires (Up to 12 weeks); Probability of response at week 12 conditional on response at week 6 and continuation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and continuation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and augmentation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and treatment switching (At 12 weeks); Probability that treatment continuation, switching, or augmentation confers benefit conditional upon failing to quit after the initial treatment with nicotine patch + lozenge for six weeks (12 weeks); Probability that treatment continuation, switching, or augmentation confers benefit conditional upon failing to quit after initial treatment with varenicline for six weeks (12 weeks)
C: Quit Rate (Study weeks 6 through 9)
D: Varenicline Adherence as Measured by Pill Count (Weeks 0-1, 1-2, 2-3, 4-6, 7-9, 10-12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Smoking Cessation Treatment for Methadone Maintenance Patients
Brief Summary: This randomized trial will evaluate whether varenicline directly observed therapy provided at a methadone clinic is more efficacious than self-administered varenicline for promoting smoking cessation and enhancing adherence.


Options:
A: Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period
B: Varenicline Adherence as Measured by Pill Count (Weeks 0-1, 1-2, 2-3, 4-6, 7-9, 10-12)
C: Patient report (Within 3 days of the dental encounter)
D: Self-reported continuous abstinence of smoking and exhaled carbon monoxide levels less than 10 ppm as measured and recorded by the research nurse at weeks 12 and 52. (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Smoking Cessation Treatment for Methadone Maintenance Patients
Brief Summary: This randomized trial will evaluate whether varenicline directly observed therapy provided at a methadone clinic is more efficacious than self-administered varenicline for promoting smoking cessation and enhancing adherence.


Options:
A: 7 Day Point Prevalence Abstinence From All Forms of Tobacco (4 weeks after beginning study)
B: Long term abstinence (one year)
C: Varenicline Adherence as Measured by Pill Count (Weeks 0-1, 1-2, 2-3, 4-6, 7-9, 10-12)
D: Continuous Nicotine Abstinence (8 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The CORAL Study of a Decision Aid Tool Regarding Disclosure of Mental Health Status to an Employer: Proof of Concept Randomised Control Trial
Brief Summary: A decision aid tool (DAT) to assist mental health service users in reaching disclosure decisions in the context of employment was developed in a previous study (IRAS REC ref: 07/Q0706/21). The initial feasibility and acceptability was assessed in a group of 15 mental health service users with mean decisional conflict scores reduced from 51.98 to 35.52 after completion. 60% of participants reported that the DAT was quick to complete, 40% that it was easy, 60% that it was relevant and 80% that they would definitely or probably use it in making disclosure decisions. This current study (CORAL: Proof of concept RCT) aims to determine whether a full randomised controlled trial of the DAT is justifiable and feasible, and to optimise its design. This will consider: 1) effects of the intervention; 2) baseline predictors of disclosure; and 3) exploration of the relationship between use of the DAT and the rate of disclosure.

Eighty people who are on the caseload of a vocational specialist working with people with mental illness will be included in this study. All participants will be receiving treatment from an Improving Access to Psychological Therapies (IAPT) service or a Community Mental Health Team (CMHT). An equal number from each group will be allocated to receive either the DAT intervention or treatment as usual. Individuals from both groups will complete baseline assessment and 3month followup assessments. Those allocated to the intervention will also complete an assessment immediately following the intervention. Qualitative interviews will also be conducted at 3 months with a maximum of 15 people from the intervention group and 6 people from the control group.


Options:
A: Test if Chest Pain Choice Safely Improves Patient Knowledge. (Directly following intervention (on day 1))
B: N/A
C: decisional conflict scale (Change from baseline in decisional conflict at 3 months)
D: Feasibility of subject recruitment; feasibility of delivery of the CHD intervention and surveys in a busy practice setting; feasibility of measuring study outcomes (Measured at the end of the study period (approximately 2 years))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The CORAL Study of a Decision Aid Tool Regarding Disclosure of Mental Health Status to an Employer: Proof of Concept Randomised Control Trial
Brief Summary: A decision aid tool (DAT) to assist mental health service users in reaching disclosure decisions in the context of employment was developed in a previous study (IRAS REC ref: 07/Q0706/21). The initial feasibility and acceptability was assessed in a group of 15 mental health service users with mean decisional conflict scores reduced from 51.98 to 35.52 after completion. 60% of participants reported that the DAT was quick to complete, 40% that it was easy, 60% that it was relevant and 80% that they would definitely or probably use it in making disclosure decisions. This current study (CORAL: Proof of concept RCT) aims to determine whether a full randomised controlled trial of the DAT is justifiable and feasible, and to optimise its design. This will consider: 1) effects of the intervention; 2) baseline predictors of disclosure; and 3) exploration of the relationship between use of the DAT and the rate of disclosure.

Eighty people who are on the caseload of a vocational specialist working with people with mental illness will be included in this study. All participants will be receiving treatment from an Improving Access to Psychological Therapies (IAPT) service or a Community Mental Health Team (CMHT). An equal number from each group will be allocated to receive either the DAT intervention or treatment as usual. Individuals from both groups will complete baseline assessment and 3month followup assessments. Those allocated to the intervention will also complete an assessment immediately following the intervention. Qualitative interviews will also be conducted at 3 months with a maximum of 15 people from the intervention group and 6 people from the control group.


Options:
A: Change of Social Support Scale (Changes from Baseline Social Support Scale at 4 months); Change of Chinese Health Questionnaire-12 (Change from Baseline Chinese Health Questionnaire-12 at 4 months); Change of Brief Psychiatric Rating Scale-18 (Change from Baseline Brief Psychiatric Rating Scale-18 at 4 months); Change of Global Assessment of Function (Change from Baseline Global Assessment of Function at 4 months); Change of Chinese version of the Social Functioning Scale (Change from Baseline Chinese version of the Social Functioning Scale at 4 months)
B: decisional conflict scale (Change from baseline in decisional conflict at 3 months)
C: Recruitment rates (Through study completion, an average of 1 year); Enrollment rates (Through study completion, an average of 1 year)
D: Shared Decision Making Questionnaire (CollaboRATE) (Level of Shared Decision Making at end of treatment (this will be at approximately week 8))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of a Single-dose Mebendazole Against Soil-transmitted Helminths in School Children
Brief Summary: Objectives:

The overall objective is to monitor efficacy of mebendazole (MBZ) against Soil-Transmitted Helminths (STH).

The primary objective is:

(1) to monitor the efficacy a single dose 500 mg of mebendazole (MBZ) against Soil-Transmitted Helminths (STH) infections by means of Faecal Egg Count Reduction (FECR) and Cure Rate (CR).

The secondary objectives are:

1. to assess the occurrence of Necator americanus and Ancylostoma duodenal.
2. to assess the occurrence of β-tubulin mutations related to resistance before and after drug administration.
3. to evaluate the role of dogs and pigs as reservoir for zoonotic transmission.


Options:
A: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence (Measured 12 and 24 months after intervention)
B: Change in markers of HIV-1 disease progression (12 weeks); CD4 count (12 weeks); HIV-1 RNA level (12 weeks); Genital HIV-1 RNA levels (12 weeks)
C: Reduction of fecal egg counts at 14 days post-intervention. (At 14 days post-intervention.)
D: CD4 count (every 6 months for 24 months (enrollment and months 6, 12, 18, and 24 )); HIV-1 RNA level (enrollment, 12, and 24 months.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Probiotics Supplementation and Nutritional Benefit in Premature Infants
Brief Summary: The main objective is to assess the nutritional benefit of probiotics supplementation on premature infants growth. As secondary objectives, different parameters related to probiotics tolerance will be measured.


Options:
A: Weight (g) (From 4 to 6 weeks after inclusion)
B: Number of deaths and episodes of nosocomial sepsis among probiotic exposed and non-exposed preterm infants (From birth to discharge from the NICU or death. Average time 2 months.)
C: Success if Patient reaches 50% of Nutritional needs by Enteral Nutrition (at D14 and D21.)
D: Stool Microbiome (4 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Probiotics Supplementation and Nutritional Benefit in Premature Infants
Brief Summary: The main objective is to assess the nutritional benefit of probiotics supplementation on premature infants growth. As secondary objectives, different parameters related to probiotics tolerance will be measured.


Options:
A: Weight (g) (From 4 to 6 weeks after inclusion)
B: Number of participants with allergic disease (Up to 13 years); Weight gain (Up to 13 years); Number of patients with chronic inflammatory disease (Up to 13 years)
C: Necrotizing enterocolitis (8 weeks)
D: Number of deaths and episodes of nosocomial sepsis among probiotic exposed and non-exposed preterm infants (From birth to discharge from the NICU or death. Average time 2 months.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect on Gait and Activity Level of a Physiotherapy Intervention Aimed at Improving Mediolateral Stability 4 Months After a Hip Fracture
Brief Summary: To evaluate the effect on gait and activity of a home based physiotherapy intervention 4-6 months after the fracture. The investigators hypothesis is that exercises performed after the initial rehabilitation, which focuses on specific components of gait control will improve gait and increase level of activity.


Options:
A: Knee-extension strength in the fractured limb in comparison with the non-fractured limb. (At inclusion, at postoperative day 10 and/or at discharge.)
B: Change in the performance-based Short physical performance battery (SPPB) (Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery)
C: Analysis of feasibility (Up to 4 weeks)
D: change in gait speed (4,6 and 12 months postfracture)

Answer: D