TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot of Customized Continuous Care Management of Obesity in Pre-Diabetics
Brief Summary: The purpose of the E-LITE Study is to evaluate the feasibility and potential effectiveness of two lifestyle interventions in a community based primary care setting. The study aims to assess how changes in diet, exercise, and behavioral self-management affect weight and related risk factors for adults at risk for diabetes and cardiovascular disease.


Options:
A: Body Mass Index (Baseline, 3-, 6- and 15- month follow-up)
B: Change in ambulatory activity (walking) (12 months)
C: First Occurrence of a Severe Cardiovascular Event (up to 11 years)
D: Development of Diabetes. (Outcomes were assessed from 1996-2008 (approximately 12 years including 6 years of DPP).); Prevalence of Aggregate Microvascular Complication (Outcomes were assessed from 2012-2013 (approximately 2 years).); Total Cancer Except Non-melanoma Skin Cancer (Outcomes were assessed from 1996-2020 (approximately 24 years).); Major Adverse Cardiovascular Events (MACE): Myocardial Infarction (MI), Stroke, or Cardiovascular Death (CVD) (Outcomes were assessed from 1996-2025 (approximately 29 years).)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Dental Brushing for Preventing Ventilator-Associated Pneumonia
Brief Summary: Poor oral hygiene is associated with respiratory pathogen colonization and secondary lung infection.The possible association between oral care and incidence of VAP, and the role of dental plaque, mouth and tracheal colonization have not been firmly established. The investigators' hypothesis was that improving oral care with electrical toothbrushing might be effective in reducing the incidence of VAP.


Options:
A: Ventilator-Associated Pneumonia (VAP) (28 days)
B: Intensive Care Unit (ICU) Mortality (14 months)
C: Development of Ventilator Acquired Pneumonia (During the period of intubation)
D: Development of VAP (Clinical Pulmonary Infection Score) (Baseline up to 5 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Dental Brushing for Preventing Ventilator-Associated Pneumonia
Brief Summary: Poor oral hygiene is associated with respiratory pathogen colonization and secondary lung infection.The possible association between oral care and incidence of VAP, and the role of dental plaque, mouth and tracheal colonization have not been firmly established. The investigators' hypothesis was that improving oral care with electrical toothbrushing might be effective in reducing the incidence of VAP.


Options:
A: Development of Ventilator Acquired Pneumonia (During the period of intubation)
B: Ventilator-Associated Pneumonia (VAP) (28 days)
C: N/A
D: Prevention of ventilator-associated pneumonia (60 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Dengue Vaccine in Healthy Children Aged 4 to 11 Years in Thailand
Brief Summary: The primary objective of the study was to assess the efficacy of CYD dengue vaccine after three injections in preventing symptomatic virologically-confirmed dengue (VCD) cases, regardless of the severity, due to any of the four serotypes in children aged 4 to 11 years at the time of inclusion.

Secondary objectives included to assess:

* Vaccine efficacy against severe VCD cases
* Vaccine efficacy against VCD cases following at least two injections with CYD dengue vaccine
* Immune response to CYD dengue vaccine
* Safety profile of CYD dengue vaccine. Safety assessments include solicited reactions within 7 or 14 days after each injection, unsolicited adverse events within 28 days after each injection, and serious adverse events during the study period.

Other objectives included:

* Vaccine efficacy against VCD cases following at least one injection with CYD dengue vaccine
* Vaccine efficacy against VCD cases due to each serotype
* Participants with clinical signs and symptoms for VCD


Options:
A: Number of Symptomatic Virologically Confirmed Dengue (VCD) Cases Due to Any Serotype During the Active Phase Post-dose 3 Following Injection With Either CYD Dengue Vaccine or a Placebo (28 days and up to 13 months post-injection 3)
B: Number of Symptomatic Virologically-Confirmed Dengue (VCD) Cases During the Active Phase Post-dose 3 Following Inj. With Either CYD Dengue Vaccine or a Placebo (28 days Post-Inj. 3 up to the end of Active Phase (up to 13 months Post-Inj. 3, i.e. up to 25 months))
C: Number of Symptomatic Virologically Confirmed Dengue (VCD) Cases Due to Any Serotype During the Active Phase Post-dose 3 Following Injection (Inj.) With Either CYD Dengue Vaccine or a Placebo (28 days and up to 13 months post-dose 3)
D: Odds ratio of Wolbachia exposure distribution among laboratory-confirmed reported dengue cases compared to test-negative controls (Up to 3 years); Laboratory-confirmed reported dengue case counts normalized by population size in intervention versus non-intervention clusters (Up to 3 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pharmacological Management of Delirium
Brief Summary: The purpose of this study is to develop and test the feasibility of using a specific pharmacological protocol to reduce delirium burden among older adults in the Intensive Care Unit (ICU). The study will test the efficacy of a pharmacological intervention in reducing delirium severity and duration as well as length of stay and mortality compared to usual care.


Options:
A: Reduction of ICU delirium duration assessed by ICDSC checklist (during stay at ICU, an average of 3 days; Delirium duration assessed every 8 hours starting with patient's ICU admission until delirium has subsided)
B: Days Free of Delirium and Coma (Admission through day 8 of stay)
C: Time from the commencement of treatment to extubation (days)
D: Duration of delirium (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Controlled, Randomized, Patient and Evaluator Blinded Study to Evaluate Pain and Recovery in Patients Undergoing Laparoscopic Umbilical Hernia Repair by Fixing the Mesh With Tisseel Versus Tackers
Brief Summary: The purpose of this study is to determine whether mesh fixation in laparoscopic umbilical hernia repair with fibrin glue is superior to tacks in terms of postoperative pain and recovery.


Options:
A: Pain (1 measurement, 2nd postoperative day)
B: Postoperative pain VAS 0-100 mm (1 year)
C: recurrence rate after hernia surgery (5 years)
D: Postoperative pain recorded in SF-36 (3 weeks after surgery)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Comparison of Two Internet Supported Natural Family Planning Methods
Brief Summary: The purpose of this research study is to compare the effectiveness of two natural family planning (NFP) methods that are provided over the internet by the Marquette University Institute for Natural Family Planning. One of the NFP methods is the use of a hand held electronic hormonal fertility monitor. The other method involves the self-observation of cervical mucus to track fertility. Both of the methods will involve placing information about fertility into an online charting system that automatically displays the days of fertility and infertility. The investigators are also interested in the influence of mutual motivation by the woman and her partner in using these methods to avoid pregnancy. The investigators hypothesize that there will be lower unintended pregnancy rates among those couples who use the electronic hormonal fertility monitor and among those couples who have a strong motivation to avoid pregnancy.


Options:
A: Cortisol Measurement (Twice monthly)
B: Collection of early pregnancy urine samples. (60 days)
C: Unintended Pregnancies (1, 3, 6, and 12 months)
D: Ultrasound (Participants will be followed for one menstrual cycle, anticipated average of four weeks.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Fibroblast Growth Factor-23 Reduction in Predialysis Chronic Kidney Disease
Brief Summary: The investigators would like to study the role of phosphorus metabolism in the development of certain hormonal problems in people with chronic kidney disease (CKD). More specifically, the goals of the research are (1) to understand the cause of hyperparathyroidism - a hormone problem that often develops in patients who have kidney disease and (2) to test whether decreasing phosphorus intake could help improve or prevent hyperparathyroidism.


Options:
A: electron-beam CT coronary artery calcification AGATSTON score (change at 12 mo from baseline)
B: Total phosphorus bound and entrapped per piece of chewing gum (60 minutes)
C: Correlation between fasting salivary phosphorus and estimated glomerular filtration rate (single value between 7-11 am); Correlation between post meal salivary phosphorus and estimated glomerular filtration rate (single value after meal between 1-4 pm)
D: Percentage Changes in Fibroblast Growth Factor-23 (FGF-23) Levels (Week 0 - 12); Percentage Changes in Parathyroid Hormone (PTH) Levels (Week 0 - 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Fibroblast Growth Factor-23 Reduction in Predialysis Chronic Kidney Disease
Brief Summary: The investigators would like to study the role of phosphorus metabolism in the development of certain hormonal problems in people with chronic kidney disease (CKD). More specifically, the goals of the research are (1) to understand the cause of hyperparathyroidism - a hormone problem that often develops in patients who have kidney disease and (2) to test whether decreasing phosphorus intake could help improve or prevent hyperparathyroidism.


Options:
A: The change in plasma phosphorus after 8 weeks of niacinamide versus placebo (8 weeks)
B: Correlation between fasting salivary phosphorus and estimated glomerular filtration rate (single value between 7-11 am); Correlation between post meal salivary phosphorus and estimated glomerular filtration rate (single value after meal between 1-4 pm)
C: To determine the effect of a phosphorus additives educational intervention on serum phosphorus levels. (3 months)
D: Percentage Changes in Fibroblast Growth Factor-23 (FGF-23) Levels (Week 0 - 12); Percentage Changes in Parathyroid Hormone (PTH) Levels (Week 0 - 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Telemedicine for Smoking Cessation in Rural Primary Care
Brief Summary: People who smoke cigarettes and live in rural areas may not have access to a wide variety of resources to help them stop smoking. This study will evaluate two smoking cessation programs-an Internet-based telemedicine program and a telephone-based quitline program-among rural residents.


Options:
A: 30 days prolonged abstinence (6-months postpartum)
B: Validated 7-day point prevalence tobacco abstinence (6 months after discharge)
C: 7-day point prevalence abstinence (Measured at Months 3, 6, and 12)
D: 30-day point prevalence tobacco abstinence (6 months); Change in weight (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Telemedicine for Smoking Cessation in Rural Primary Care
Brief Summary: People who smoke cigarettes and live in rural areas may not have access to a wide variety of resources to help them stop smoking. This study will evaluate two smoking cessation programs-an Internet-based telemedicine program and a telephone-based quitline program-among rural residents.


Options:
A: Quit Rate (30-day Follow-Up); Quit Rate (6-Month Follow-Up)
B: Reproductive rate (30 days)
C: 7-day point prevalence abstinence (Measured at Months 3, 6, and 12)
D: Change in tobacco smoking (6 months); Change in level of physical activity (6 months); Change in diet quality (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Telemedicine for Smoking Cessation in Rural Primary Care
Brief Summary: People who smoke cigarettes and live in rural areas may not have access to a wide variety of resources to help them stop smoking. This study will evaluate two smoking cessation programs-an Internet-based telemedicine program and a telephone-based quitline program-among rural residents.


Options:
A: Validated 7-day point prevalence tobacco abstinence (6 months after discharge)
B: 7-day point prevalence abstinence (Measured at Months 3, 6, and 12)
C: Number of Participants With Abstinence (6-month follow-up)
D: Self-reported Quit Attempts - The Primary Outcome is the Number of Veteran's Who Make a Self-reported Quit Attempt (as Defined as a 24-hour Point Prevalence Rate). (During 90-session intervention period); Number of Participants Who Progressed Along the Stage of Change Toward Action as Measured by the Transtheoretical Model of Change (Short Form) Questionnaire. This Will Identify Current Stage of Change for Each Subject. (During 90-session intervention period); Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days. (During 90-session intervention period); Self-reported Quit Attempts - The Primary Outcome is the Number of Veteran's Who Make a Self-reported Quit Attempt (as Defined as a 24-hour Point Prevalence Rate). (During the 6-month follow-up period); Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days. (During the 6-month follow-up period); Number of Participants Who Progressed Along the Stage of Change Toward Action as Measured by the Transtheoretical Model of Change (Short Form) Questionnaire. This Will Identify Current Stage of Change for Each Subject. (During the 6-month follow-up period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of LY451395 for Neuropsychiatric Symptoms of Aggression and Agitation in Alzheimer's Disease
Brief Summary: The purpose of this study is to determine whether this drug can help symptoms of aggression and agitation in participants with Alzheimer's disease.


Options:
A: Relapse by Study Week 32 (0-16 weeks in Phase B (16-32 weeks in study))
B: Mean Change From Baseline in the 4-Item Agitation/Aggression Subscale of the Neuropsychiatric Inventory (NPI-4 A/A) at Week 12 (Baseline, Week 12)
C: Apathy (at baseline); Apathy (after 8 weeks of treatment)
D: Presence of Agitation and/or Psychosis Measured by the Neuropsychiatric Inventory (NPI) Combined With an Assessment of the Clinical Significance of Behavioral Change Rated by the Study Clinician (24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of an Integrative Medicine Approach to the Management of Asthma in Adults on Quality of Life and Clinical Outcomes
Brief Summary: The overall aim of this research project is to test the effectiveness of an integrative program, using journaling, yoga breathing instruction, and nutritional manipulation and supplementation, on quality of life and clinical outcomes in adults with asthma. An additional aim is to determine whether an integrative approach to asthma management leads to cost savings when compared to standard clinical care.Patients will be randomly assigned to either the intervention condition or a waitlist control condition. For the intervention group, all measures will be obtained at baseline, immediately after the treatment protocol is completed, and then at three month and six month intervals after the completion of the intervention. For the control group, data will be collected at the same times as the intervention group, with one exception: data collected at the completion of the treatment protocol will be replaced with data collection at six weeks post-baseline for the control group. Data will be collected using measures of quality of life (Asthma Quality of Life Questionnaire and SF-12), pulmonary function and health care utilization and expenditures.

Participants assigned to the treatment group will begin in groups of ten. The treatment protocol will consist of six 1-2 hour sessions over a six-week period as follows:

1. Subjects will attend a two-session class on healthy eating focused on reducing inflammation-promoting foods in the diet. All subjects will also be started on fish oil and vitamin C supplements, as well as on a supplement called Kaprex, which is an extract from hops and rosemary with anti-inflammatory action. Supplements willl be provided free of charge. Subjects will be provided with a take home supply to begin using.
2. Subjects will attend two classes at CCHH in yoga breathing techniques and will then be provided with a CD for home study and practice
3. Subjects will attend two guided journaling sessions at CCHH in which subjects will be asked to write for a 30-minute period about the most traumatic or stressful life experience to date.


Options:
A: N/A
B: Symptom-free days; Quality of Life Questionnaire (AQLQ, PAQLQ); Rate of asthma-related hospitalizations over 18 months of enrollment; Rate of asthma-related emergency room (ER) visits over 18 months of enrollment
C: Asthma Quality of Life Questionnaire (Baseline, 6 weeks, 3 months, 6 months)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of an Integrative Medicine Approach to the Management of Asthma in Adults on Quality of Life and Clinical Outcomes
Brief Summary: The overall aim of this research project is to test the effectiveness of an integrative program, using journaling, yoga breathing instruction, and nutritional manipulation and supplementation, on quality of life and clinical outcomes in adults with asthma. An additional aim is to determine whether an integrative approach to asthma management leads to cost savings when compared to standard clinical care.Patients will be randomly assigned to either the intervention condition or a waitlist control condition. For the intervention group, all measures will be obtained at baseline, immediately after the treatment protocol is completed, and then at three month and six month intervals after the completion of the intervention. For the control group, data will be collected at the same times as the intervention group, with one exception: data collected at the completion of the treatment protocol will be replaced with data collection at six weeks post-baseline for the control group. Data will be collected using measures of quality of life (Asthma Quality of Life Questionnaire and SF-12), pulmonary function and health care utilization and expenditures.

Participants assigned to the treatment group will begin in groups of ten. The treatment protocol will consist of six 1-2 hour sessions over a six-week period as follows:

1. Subjects will attend a two-session class on healthy eating focused on reducing inflammation-promoting foods in the diet. All subjects will also be started on fish oil and vitamin C supplements, as well as on a supplement called Kaprex, which is an extract from hops and rosemary with anti-inflammatory action. Supplements willl be provided free of charge. Subjects will be provided with a take home supply to begin using.
2. Subjects will attend two classes at CCHH in yoga breathing techniques and will then be provided with a CD for home study and practice
3. Subjects will attend two guided journaling sessions at CCHH in which subjects will be asked to write for a 30-minute period about the most traumatic or stressful life experience to date.


Options:
A: Asthma Quality of Life Questionnaire (Baseline, 6 weeks, 3 months, 6 months)
B: Episodes of Poor Asthma Control (EPAC) From Diary Cards, According to Definition That Did Not Include Use of Beta-agonists as a Criterion (Baseline to 24 Weeks)
C: Number of Participants With Major Cardiovascular Events (a Combined Endpoint of Nonfatal Myocardial Infarction, Nonfatal Stroke, and Total Cardiovascular Death) (Average follow-up 10.1 years); Number of Participants With Cancer, Excluding Nonmelanoma Skin Cancer (Average follow-up 10.1 years)
D: asthma free days (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of an Integrative Medicine Approach to the Management of Asthma in Adults on Quality of Life and Clinical Outcomes
Brief Summary: The overall aim of this research project is to test the effectiveness of an integrative program, using journaling, yoga breathing instruction, and nutritional manipulation and supplementation, on quality of life and clinical outcomes in adults with asthma. An additional aim is to determine whether an integrative approach to asthma management leads to cost savings when compared to standard clinical care.Patients will be randomly assigned to either the intervention condition or a waitlist control condition. For the intervention group, all measures will be obtained at baseline, immediately after the treatment protocol is completed, and then at three month and six month intervals after the completion of the intervention. For the control group, data will be collected at the same times as the intervention group, with one exception: data collected at the completion of the treatment protocol will be replaced with data collection at six weeks post-baseline for the control group. Data will be collected using measures of quality of life (Asthma Quality of Life Questionnaire and SF-12), pulmonary function and health care utilization and expenditures.

Participants assigned to the treatment group will begin in groups of ten. The treatment protocol will consist of six 1-2 hour sessions over a six-week period as follows:

1. Subjects will attend a two-session class on healthy eating focused on reducing inflammation-promoting foods in the diet. All subjects will also be started on fish oil and vitamin C supplements, as well as on a supplement called Kaprex, which is an extract from hops and rosemary with anti-inflammatory action. Supplements willl be provided free of charge. Subjects will be provided with a take home supply to begin using.
2. Subjects will attend two classes at CCHH in yoga breathing techniques and will then be provided with a CD for home study and practice
3. Subjects will attend two guided journaling sessions at CCHH in which subjects will be asked to write for a 30-minute period about the most traumatic or stressful life experience to date.


Options:
A: Asthma Quality of Life Questionnaire (Baseline, 6 weeks, 3 months, 6 months)
B: Episodes of Poor Asthma Control (EPAC) From Diary Cards, According to Definition That Did Not Include Use of Beta-agonists as a Criterion (Baseline to 24 Weeks)
C: asthma free days (12 weeks)
D: 7-item Juniper Asthma Control Questionnaire (ACQ) (6-months post-randomizaton)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Program of TCM on Early Rehabilitation and Secondary Prevention of Ischemic Stroke
Brief Summary: Complex project of Traditional Chinese Medicine (TCM) with Western Medicine (WM) project under stroke unit mode contrast,assuming that the efficiency of TCM on early rehabilitation and secondary prevention of ischemic stroke is same or better than that of WM.


Options:
A: Change in daytime PaCO2 (Baseline, 6 months)
B: mortality (6 months)
C: NIHSS Stroke Scale, relapse rate (360 days)
D: Mortality, dependence, psychoscial outcome; Mortality, dependence and psychosocial outcome (6 months endpoint)

Answer: C