TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Culturally-Appropriate Childhood Obesity Prevention Program for Hispanic Families
Brief Summary: The purpose of this study is to evaluate the efficacy of a culturally-appropriate childhood obesity intervention with Hispanic families. The program aims at preventing childhood obesity by targeting parents to address nutrition, physical activity, and sedentary behaviors in their children.


Options:
A: Body Mass Index (BMI)-for-age percentile (one year)
B: Change in Child Body Mass Index (BMI Z-score) (Change from Baseline at 12 and 21 months)
C: Body Mass Index score(BMI sds) at the age 6 years to monitor the effectiveness of the intervention (5 years)
D: Changes in BMI z-score (Measured at Month 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Tobacco Treatment Outreach to Reduce Disparities for Primary Care Populations
Brief Summary: The objectives of this project are to develop and evaluate a multi-level approach to tobacco treatment for low-SES and minority patients. The components of this intervention would include Integrated Voice Response(IVR)-facilitated systematic outreach, linkage to a tobacco treatment specialist, free Nicotine Replacement Therapy (NRT) directed at the patient, and integration of this program with both an individual's primary care physician through an electronic health record (EHR), as well as referral to community resources to address the socio-contextual barriers to tobacco cessation. To achieve these objectives, this intervention will test an innovative model of systematic outreach to low-SES and minority smokers using systematic phone outreach (including cell phones which are particularly prevalent among minority and low-SES groups), coordinated with the PCP, using both a cost-effective technology and a dedicated tobacco treatment specialist to increase smoking cessation in these populations. The proposed intervention will have multiple levels of influence (patient, PCP) and provide linkages to community resources. If successful, this model could be generalized to other health systems with an EHR, which are increasingly being promoted to improve the safety and quality of health care.

Hypothesis 1 (Reach and Effectiveness): An EHR-linked, IVR-mediated personalized treatment program for low-SES and minority smokers can reach these patients to increase quit rates and use of tobacco treatment effectively.

Hypothesis 2 (Adoption and Implementation): An EHR-linked, IVR-mediated personalized treatment program for low-SES and minority smokers can be adopted across a variety of practice settings and be consistently implemented across diverse patient populations.


Options:
A: Self-reported prolonged abstinence and cotinine-validated point-prevalence abstinence at 1 year follow-up (1 year)
B: 7-day point prevalence of smoking six months following completion of the intervention protocol (nine months post randomization). (2 years)
C: Results in Abstinence Rates (1 Year)
D: Blood Pressure, Health-Related Quality of Life(Medical outcome Study Short Form-36) (Baseling, 12month, 24month)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Tobacco Treatment Outreach to Reduce Disparities for Primary Care Populations
Brief Summary: The objectives of this project are to develop and evaluate a multi-level approach to tobacco treatment for low-SES and minority patients. The components of this intervention would include Integrated Voice Response(IVR)-facilitated systematic outreach, linkage to a tobacco treatment specialist, free Nicotine Replacement Therapy (NRT) directed at the patient, and integration of this program with both an individual's primary care physician through an electronic health record (EHR), as well as referral to community resources to address the socio-contextual barriers to tobacco cessation. To achieve these objectives, this intervention will test an innovative model of systematic outreach to low-SES and minority smokers using systematic phone outreach (including cell phones which are particularly prevalent among minority and low-SES groups), coordinated with the PCP, using both a cost-effective technology and a dedicated tobacco treatment specialist to increase smoking cessation in these populations. The proposed intervention will have multiple levels of influence (patient, PCP) and provide linkages to community resources. If successful, this model could be generalized to other health systems with an EHR, which are increasingly being promoted to improve the safety and quality of health care.

Hypothesis 1 (Reach and Effectiveness): An EHR-linked, IVR-mediated personalized treatment program for low-SES and minority smokers can reach these patients to increase quit rates and use of tobacco treatment effectively.

Hypothesis 2 (Adoption and Implementation): An EHR-linked, IVR-mediated personalized treatment program for low-SES and minority smokers can be adopted across a variety of practice settings and be consistently implemented across diverse patient populations.


Options:
A: Composite Assessment of Function and Survival (CAFS) at 12 Months (12 months); Death up to 12 Months (CAFs Individual Component) (12 months); Change From Baseline in ALSFRS-R at 12 Months (CAFs Individual Component) (12 months)
B: Participation in exercise (weekly minutes of exercise) at 6 months.
C: Weight (Measured at Month 24)
D: 7-day point prevalence of smoking six months following completion of the intervention protocol (nine months post randomization). (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Tobacco Treatment Outreach to Reduce Disparities for Primary Care Populations
Brief Summary: The objectives of this project are to develop and evaluate a multi-level approach to tobacco treatment for low-SES and minority patients. The components of this intervention would include Integrated Voice Response(IVR)-facilitated systematic outreach, linkage to a tobacco treatment specialist, free Nicotine Replacement Therapy (NRT) directed at the patient, and integration of this program with both an individual's primary care physician through an electronic health record (EHR), as well as referral to community resources to address the socio-contextual barriers to tobacco cessation. To achieve these objectives, this intervention will test an innovative model of systematic outreach to low-SES and minority smokers using systematic phone outreach (including cell phones which are particularly prevalent among minority and low-SES groups), coordinated with the PCP, using both a cost-effective technology and a dedicated tobacco treatment specialist to increase smoking cessation in these populations. The proposed intervention will have multiple levels of influence (patient, PCP) and provide linkages to community resources. If successful, this model could be generalized to other health systems with an EHR, which are increasingly being promoted to improve the safety and quality of health care.

Hypothesis 1 (Reach and Effectiveness): An EHR-linked, IVR-mediated personalized treatment program for low-SES and minority smokers can reach these patients to increase quit rates and use of tobacco treatment effectively.

Hypothesis 2 (Adoption and Implementation): An EHR-linked, IVR-mediated personalized treatment program for low-SES and minority smokers can be adopted across a variety of practice settings and be consistently implemented across diverse patient populations.


Options:
A: Comparison of change in diabetes quality of care between intervention and usual care group. (6 months follow-up)
B: Body weight change (baseline and after 4weeks of lifestyle intervention)
C: The proportion of control and intervention subjects who are current on EACH individual indicated preventive service (Annual for three years); The proportion of control and intervention subjects who are current on ALL indicated preventive services (Annual for three years); The mean score for intervention and control subjects for quality of clinician communication (CAPHS-CGS questions 14-20); and frequency with which patients report sharing medical decisions (CAHPS questions SD 1-3) (Annual for three years)
D: 7-day point prevalence of smoking six months following completion of the intervention protocol (nine months post randomization). (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Tobacco Treatment Outreach to Reduce Disparities for Primary Care Populations
Brief Summary: The objectives of this project are to develop and evaluate a multi-level approach to tobacco treatment for low-SES and minority patients. The components of this intervention would include Integrated Voice Response(IVR)-facilitated systematic outreach, linkage to a tobacco treatment specialist, free Nicotine Replacement Therapy (NRT) directed at the patient, and integration of this program with both an individual's primary care physician through an electronic health record (EHR), as well as referral to community resources to address the socio-contextual barriers to tobacco cessation. To achieve these objectives, this intervention will test an innovative model of systematic outreach to low-SES and minority smokers using systematic phone outreach (including cell phones which are particularly prevalent among minority and low-SES groups), coordinated with the PCP, using both a cost-effective technology and a dedicated tobacco treatment specialist to increase smoking cessation in these populations. The proposed intervention will have multiple levels of influence (patient, PCP) and provide linkages to community resources. If successful, this model could be generalized to other health systems with an EHR, which are increasingly being promoted to improve the safety and quality of health care.

Hypothesis 1 (Reach and Effectiveness): An EHR-linked, IVR-mediated personalized treatment program for low-SES and minority smokers can reach these patients to increase quit rates and use of tobacco treatment effectively.

Hypothesis 2 (Adoption and Implementation): An EHR-linked, IVR-mediated personalized treatment program for low-SES and minority smokers can be adopted across a variety of practice settings and be consistently implemented across diverse patient populations.


Options:
A: Reduction in number of cigarettes smoked as measured by the Timeline Follow-back. (Baseline, Pre Counseling Sessions 1-5, Weeks 8, 12, 24)
B: 7-day point prevalence of smoking six months following completion of the intervention protocol (nine months post randomization). (2 years)
C: 7-day Point Prevalence Abstinence From Cigarettes (24 months)
D: Long-term Smoking Abstinence (30-day Point Prevalence Abstinence) (6 months after enrollment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Tobacco Treatment Outreach to Reduce Disparities for Primary Care Populations
Brief Summary: The objectives of this project are to develop and evaluate a multi-level approach to tobacco treatment for low-SES and minority patients. The components of this intervention would include Integrated Voice Response(IVR)-facilitated systematic outreach, linkage to a tobacco treatment specialist, free Nicotine Replacement Therapy (NRT) directed at the patient, and integration of this program with both an individual's primary care physician through an electronic health record (EHR), as well as referral to community resources to address the socio-contextual barriers to tobacco cessation. To achieve these objectives, this intervention will test an innovative model of systematic outreach to low-SES and minority smokers using systematic phone outreach (including cell phones which are particularly prevalent among minority and low-SES groups), coordinated with the PCP, using both a cost-effective technology and a dedicated tobacco treatment specialist to increase smoking cessation in these populations. The proposed intervention will have multiple levels of influence (patient, PCP) and provide linkages to community resources. If successful, this model could be generalized to other health systems with an EHR, which are increasingly being promoted to improve the safety and quality of health care.

Hypothesis 1 (Reach and Effectiveness): An EHR-linked, IVR-mediated personalized treatment program for low-SES and minority smokers can reach these patients to increase quit rates and use of tobacco treatment effectively.

Hypothesis 2 (Adoption and Implementation): An EHR-linked, IVR-mediated personalized treatment program for low-SES and minority smokers can be adopted across a variety of practice settings and be consistently implemented across diverse patient populations.


Options:
A: Smoking abstinence: Self reported abstinence (6 or more months without smoking) confirmed by an expired air carbon monoxide concentration of 6 parts per millions or less (12 months after initiation of study)
B: 7-day point prevalence of smoking six months following completion of the intervention protocol (nine months post randomization). (2 years)
C: Participants Abstinent From Cigarettes (Two years)
D: 7-day Point Prevalence Abstinence From Cigarettes (24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pulmonary Hypertension Secondary to Heart Failure With Preserved Systolic Function: a Target of Phosphodiesterase - 5 Inhibition in a 1- Year Duration Study
Brief Summary: Prevalence of heart failure (HF) with left ventricular (LV) diastolic dysfunction and preserved ejection fraction (EF) (HFpEF) is increasing. Prognosis worsens with development of pulmonary vasoconstriction and hypertension (PH) and right ventricular (RV) failure. The investigators aimed at modulating pulmonary vascular tone and RV burden in HFpEF due to high blood pressure (HBP), by using the phosphodiesterase-5 (PDE5) inhibitor sildenafil.


Options:
A: Change in 6-minute Walk Test (0 - 6 months)
B: Pulmonary hemodynamics (1 year)
C: Percent Change From Baseline in Peak Volume of Oxygen (VO2) Consumed : Intent To Treat Population (Baseline, Week 16); Percent Change From Baseline in Peak Volume of Oxygen (VO2) Consumed : Per Protocol Population (Baseline, Week 16)
D: Number of Patients Reaching a 6-Minute Walk Test (6MWT) Distance ≥ 380 Meters (at 16 weeks and at 28 weeks of a stepped approach to therapy)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Five-Treatment, Four 6-Week Period Cross-Over, Multi-Center Study to Evaluate the Effect of Adding GSK2190915 100mg, GSK2190915 300mg, Montelukast 10mg or Placebo Tablets Once Daily or Salmeterol 50mcg Inhalation Powder Twice Daily to Fluticasone Propionate 100mcg Inhalation Powder Twice Daily in Uncontrolled Asthmatic Subjects ≥ 12 Years of Age
Brief Summary: The primary objective of this study is to evaluate the efficacy and safety of adding GSK2190915 100mg, GSK2190915 300mg or placebo tablets administered once daily to fluticasone propionate 100mcg inhalation administered twice daily in uncontrolled asthmatic subjects \> or = 12 years of age over the course of 6 weeks treatment.

The secondary objectives are to undertake an exploratory analysis of the efficacy and safety of adding montelukast 10mg administered once daily or salmeterol 50mcg administered twice daily to fluticasone propionate 100mcg inhalation administered twice daily and to investigate the pharmacokinetics and pharmacodynamics of GSK2190915 in uncontrolled asthmatic subjects \> or = 12 years of age over the course of 6 weeks treatment.


Options:
A: The Number of Participants With a Differential Response to the Three Step-up Therapies Based on Fixed Threshold Criteria for the Following Three Asthma Control Measures: Use of Oral Prednisone for Acute Asthma Exacerbations, Asthma Control Days and FEV1. (Measured during the last 12 weeks of each 16-week treatment period)
B: N/A
C: To evaluate distal airway function using high-resolution CT and lung function test (6 months)
D: Trough (AM Pre-dose and Pre-rescue Bronchodilator) Forced Expiratory Volume in 1 Second (FEV1) at the End of the 6-week Treatment Period (End of Week 6)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of an School-based Intervention in Eating Habits and Physical Activity in Schoolchildren: the AVall Study.
Brief Summary: The objective of the study is to evaluate the efficacy of an intervention on food habits and physical activity in school-age children.


Options:
A: Anthropometric Variables (every two years)
B: Effectiveness of a nutrition advice programme in exclusive breastfeeding. (1 year); Effectiveness of a nutrition advice programme in dietary intake (1 year); Effectiveness of a nutrition advice programme in dietary intake (4 years); Effectiveness of a nutrition advice programme in dietary intake (8 years); Effectiveness of a nutrition advice programme in dietary intake (12 years)
C: Diet plan recall directly after visit (On day of primary visit); Activity plan recall directly after visit (On day of primary visit, directly after seeing physician)
D: Body mass index BMI: derived from measured body height (m) and body weight (kg) as body weight / height² (At age 11 years and 18 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicentre, Clinical Study Investigating the Efficacy and Safety of 3-months Open-label Treatment With PGL4001, Followed by a Randomised, Double-blind Placebo Controlled Period of 10 Days Treatment With Progestin, in Subjects With Myomas and Heavy Uterine Bleeding.
Brief Summary: This is a multicentre, Phase III, efficacy and safety open-label study with PGL4001 10mg once daily for 3 months, blinded towards the administration of progestin or placebo after end of PGL4001 treatment.


Options:
A: Percentage of Subjects With Reduction of Uterine Bleeding at Week 13 Visit Defined as Pictorial Blood-loss Assessment Chart (PBAC) Score < 75 at End-of-treatment Visit (Week 13 Visit) (3 months); Co-primary Safety Endpoint: Serum Estradiol Levels at End of Treatment Visit (Week 13 Visit) for PGL4001 Compared With GnRHagonist (Week 13 visit); Co-primary Safety Endpoint: % of Subjects Reporting Moderate or Severe Hot Flushes as Adverse Events Throughout the Treatment Period for PGL4001 Compared With GnRH-agonist (Up to week 17)
B: Shrinkage of Fibroids - Size of Fibroids (3 months (baseline to end of treatment))
C: Co-primary Endpoint: Percentage of Subjects With Reduction in Uterine Bleeding Defined as a Pictorial Blood-loss Assessment Chart (PBAC) Score <75 at End-of-treatment Visit (Week 13) (Week 13 visit); Co-primary Endpoint: Percent Change in Total Myoma Volume Assessed by Magnetic Resonance Imaging (MRI) From Screening to End of Treatment Visit (Week 13 Visit) (Week 13)
D: Efficacy endpoints (From baseline to end of PGL4001 treatment (3months treatment) and to approximately 2 weeks after double blind treatment with progestin/placebo.); Number and proportion of subjects experiencing open label treatment-emergent adverse events (From baseline to end of PGL4001 treatment (3months treatment))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicentre, Clinical Study Investigating the Efficacy and Safety of 3-months Open-label Treatment With PGL4001, Followed by a Randomised, Double-blind Placebo Controlled Period of 10 Days Treatment With Progestin, in Subjects With Myomas and Heavy Uterine Bleeding.
Brief Summary: This is a multicentre, Phase III, efficacy and safety open-label study with PGL4001 10mg once daily for 3 months, blinded towards the administration of progestin or placebo after end of PGL4001 treatment.


Options:
A: Volume of the uterine leiomyomata with 2,5mg vs 5 mg daily of mifepristone after 3 months of treatment (3 months)
B: Efficacy endpoints (From baseline to end of PGL4001 treatment (3months treatment) and to approximately 2 weeks after double blind treatment with progestin/placebo.); Number and proportion of subjects experiencing open label treatment-emergent adverse events (From baseline to end of PGL4001 treatment (3months treatment))
C: Percent change from baseline in uterine volume and volume of the largest fibroid. (Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6.); Duration of amenorrhea (Day 1 to 1st post treatment menses)
D: Percentage of Subjects Who Are in Amenorrhea at the End of All Four Treatment Courses (18 months study duration per subject (4 3-month intermittent treatment courses))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Care Guides: Can Trained Laypersons Help Manage Chronic Disease? A Randomized Trial.
Brief Summary: Trained lay persons ("care guides") working with chronic disease patients and their providers can help outpatients with diabetes, hypertension, and congestive heart failure achieve standard clinical care goals


Options:
A: Change in HbA1c (12 Months)
B: change in number of care goals met (one year)
C: Blood Pressure and Hemaglobin A1c
D: HBA1c Glycosylated hemoglobin (one year for every patient)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Care Guides: Can Trained Laypersons Help Manage Chronic Disease? A Randomized Trial.
Brief Summary: Trained lay persons ("care guides") working with chronic disease patients and their providers can help outpatients with diabetes, hypertension, and congestive heart failure achieve standard clinical care goals


Options:
A: change in number of care goals met (one year)
B: Change in performance on COPM (pre, post, 3 month follow-up)
C: N/A
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Care Guides: Can Trained Laypersons Help Manage Chronic Disease? A Randomized Trial.
Brief Summary: Trained lay persons ("care guides") working with chronic disease patients and their providers can help outpatients with diabetes, hypertension, and congestive heart failure achieve standard clinical care goals


Options:
A: Proportion of Participants that Receive Annual Eye Exam (Baseline; Change from Baseline at 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years (number of follow-up exams depends on number of years enrolled in the study))
B: Death or non-fatal myocardial infarction (Up to 10 months)
C: change in number of care goals met (one year)
D: Outcome and process measures from the danish diabetes guideline (1/3 2007-1/6 2008)

Answer: C