TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Combined Lifestyle and Medication Intervention to Reduce CVD Risk
Brief Summary: Cardiovascular disease (CVD), including heart disease and stroke, is the leading cause of death in the US. Every year, more than one million Americans have a heart attack, and nearly 800,000 have a stroke. In 2010, heart disease alone is expected to cost the country more than $316 billion in health care and lost productivity.

Both lifestyle changes and medication can reduce the risk of CVD, and this project combines these approaches in the hopes of identifying a practical intervention for use in primary care medical offices. The project combines two previously tested interventions and updates them to meet current guidelines for diet and use of aspirin and cholesterol-controlling drugs (statins).

The research team is delivering the combined intervention in two formats: web-based and counselor-based. Each format has the same content, but the web-based advice is accessed through the Internet by clients at home, a community site, or a primary care office. The other format involves sessions delivered to clients by a counselor either in person at a primary care office or over the telephone. The researchers will compare how effective each format is in reducing participants' risk of coronary heart disease. They will also determine the interventions' effect on participants' diet, physical activity, smoking status, medication adherence, and other health indicators. In addition, the team will compare the two formats' cost-effectiveness and how well the patients, office staff, and clinicians accept the interventions.

Recruited from five family practices, 600 patients representing the geographic and ethnic diversity of North Carolina are taking part in this study. Half the participants are randomly assigned to the web-based intervention; the other half to the counselor-based version. Both groups will also get information on local resources, such as gyms and farmers markets, that can help participants maintain a healthy lifestyle.


Options:
A: Reach of Intervention (Baseline 2 (post-education: average 3 days after enrollment)); Effectiveness of Intervention: Knowledge (Baseline 1 (enrollment), Baseline 2 (post-education: average 3 days after enrollment)); Adoption of Intervention (At time of intervention phase start); Implementation of Intervention (Baseline 2 (post-education: average 3 days after enrollment)); Maintenance of Intervention (6 months after study enrollment end date); Effectiveness of Intervention: Values-Choice Concordance (Baseline 1 (enrollment) and 1 Month Follow-Up)
B: Incidence choice for eSET (after embryo transfer)
C: Knowledge, risk perception, stigma, perceived control (immediately post intervention and 1 month post intervention)
D: Predicted 10-year CHD risk (4-month follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Randomized, Double-blinded Trial of the Efficacy and Safety of Different Doses and Duration of Low Molecular Weight Heparin (Dalteparin) in Superficial Vein Thrombosis
Brief Summary: The aim of the study is to establish whether treatment of superficial vein thrombosis (SVT) with low-molecular-weight heparin in preventive or therapeutic doses prevents disease progression and thromboembolic events (deep vein thrombosis and pulmonary embolism), whether efficacy of low-molecular-weight heparin differs with regard to the dosage used (prevention, treatment), and to recognize groups of patients in which treatment with heparin is most efficient, as well as to determine factors that influence the efficacy of SVT treatment with heparin.


Options:
A: Thrombosis Progression and Venous Thromboembolism (VTE) (Day 14); Thrombosis Progression or Venous Thromboembolism (VTE) at 3 Months (3 months)
B: To assess the efficacy and safety of low-molecular-weight heparin - dalteparin in patients with ST (3 months); Combined end-point: occurrence of symptomatic or asymptomatic deep vein thrombosis, symptomatic pulmonary embolism or ultrasonographic blood clot progression or relapse of ST (3 months); Clinically relevant bleeding occurring (during treatment)
C: Number of Participants With at Least on Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 47 (Baseline to Day 47)
D: Rate of Objectively Confirmed VTE Complications (45 +/- 5 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An International, Prospective, Randomized, Multicenter, Controlled Head-to-Head Comparison of Conservative, Plate Fixation and Prosthesis in Treatment of Displaced 2, 3, and 4 Part Fractures of Proximal Humerus of 60 Years and Older Patients
Brief Summary: This trial is designed to compare head-to-head conservative with operative treatment in 2 stratum. Stratum 1: In 2 part fractures the comparison is between conservative treatment and operative treatment with plate fixation with Philos. Stratum 2: In multi-fragmented fractures (MFF) meaning 3 and 4 part fractures, the comparison is between conservative treatment, operative treatment with Philos plate and operative treatment with Epoca prosthesis. Subgroup analysis will be performed in an effort to obtain limit values for specific treatment of different age and fracture groups. A cost-effectiveness analysis and comparison between different treatment modalities will be carried out. The primary outcome measure will be the DASH score and the secondary outcome measure the EQ-5D value. Recruitment period is 3 years and follow-up 2 years.


Options:
A: Quick-DASH (2 years)
B: Shoulder function (score /100) (Pre-intervention: 1 to 3 weeks post fracture (T1) and Post-intervention: after the 8-week intervention (T2))
C: DASH (6 months); DASH (1 year); DASH (2 year)
D: Change in disability of the arm, shoulder and hand (DASH) (DASH will be assessed before randomisation and followed up after completing an intervention period of 3 weeks and additionally after 3, 6 and 12 months for assessing the change)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Naltrexone for Opioid Dependent Released Human Immunodeficiency Virus Positive (HIV+) Criminal Justice Populations
Brief Summary: Specific Aim: To conduct a randomized, placebo-controlled trial of extended release-naltrexone (XR-NTX) among Human Immunodeficiency Virus (HIV) infected prisoners meeting Diagnostic Statistical Manual IV (DSM-IV) criteria for opioid dependence who are transitioning from the structure of a correctional setting to the community.

Hypotheses:

i. XR-NTX will result in improved HIV clinical outcomes, including lower changes in HIV-1 RNA levels, higher CD4 counts and higher rates of retention in care.

ii. XR-NTX will result in improved opioid treatment outcomes, including longer time to opioid relapse, lower addiction severity and lower craving for opioid.

iii. XR-NTX will result in reduced drug- and sex-related HIV risk behaviors compared to the control group.

iv. XR-NTX will result in decreased rates of reincarceration after 12 months of release to the community.


Options:
A: Participants Who Had Undetectable HIV-1 RNA Levels at Less Than 400 Copies/mL at Six Month (6 months)
B: Recurrence of intimate partner violence (18 months); Health-specific quality of life (18 months); Harms of screening and/or usual care (18 months)
C: Primary Outcome Measure (3 years)
D: Number of Case Management Sessions Completed (6-month follow-up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Naltrexone for Opioid Dependent Released Human Immunodeficiency Virus Positive (HIV+) Criminal Justice Populations
Brief Summary: Specific Aim: To conduct a randomized, placebo-controlled trial of extended release-naltrexone (XR-NTX) among Human Immunodeficiency Virus (HIV) infected prisoners meeting Diagnostic Statistical Manual IV (DSM-IV) criteria for opioid dependence who are transitioning from the structure of a correctional setting to the community.

Hypotheses:

i. XR-NTX will result in improved HIV clinical outcomes, including lower changes in HIV-1 RNA levels, higher CD4 counts and higher rates of retention in care.

ii. XR-NTX will result in improved opioid treatment outcomes, including longer time to opioid relapse, lower addiction severity and lower craving for opioid.

iii. XR-NTX will result in reduced drug- and sex-related HIV risk behaviors compared to the control group.

iv. XR-NTX will result in decreased rates of reincarceration after 12 months of release to the community.


Options:
A: Participants Who Had Undetectable HIV-1 RNA Levels at Less Than 400 Copies/mL at Six Month (6 months)
B: Relapse (6 months)
C: Acceptability (Study months 21 through 34)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Supported Home-based Exercise Training Versus Usual Care After Cardiac Rehabilitation. A Randomized Controlled Study
Brief Summary: It is known that organized cardiac rehabilitation is effective in improving exercise capacity in coronary heart disease patients. Less is known about the long-term results after cardiac rehabilitation. Earlier studies have shown that many patients quit exercising when no longer attending formal rehabilitation. The investigators wish to investigate the effect of a maintenance program after ending a rehabilitation program, and to compare this to usual care. The investigators hypothesis is that the maintenance program will result in higher exercise capacity and more physical activity compared to usual care.


Options:
A: coronary collateral blod flow (4 weeks)
B: exercise capacity as reported in total time on the exercise test using the BRUCE protocol (16 months)
C: Glucometabolic state (12 months); Atherosclerosis (12 months)
D: Peak oxygen uptake (baseline and 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A PHASE 2A, MULTI-SITE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF THE PILOT EFFICACY, SAFETY, AND PHARMACOKINETICS OF 2 OINTMENT FORMULATIONS OF CP-690,550 IN SUBJECTS WITH MILD TO MODERATE CHRONIC PLAQUE PSORIASIS
Brief Summary: The study is being conducted to see whether CP-690,550 ointment has potential as a safe and effective treatment for adult patients with mild to moderate chronic plaque psoriasis.


Options:
A: Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4 (Baseline, Week 4)
B: Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) . (12 wks); Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12 (12 wks)
C: Achievement of ≥90% Reduction From Baseline PASI Score (PASI90) at Week 12 (Baseline and Week 12)
D: Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score (Week 16)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A PHASE 2A, MULTI-SITE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF THE PILOT EFFICACY, SAFETY, AND PHARMACOKINETICS OF 2 OINTMENT FORMULATIONS OF CP-690,550 IN SUBJECTS WITH MILD TO MODERATE CHRONIC PLAQUE PSORIASIS
Brief Summary: The study is being conducted to see whether CP-690,550 ointment has potential as a safe and effective treatment for adult patients with mild to moderate chronic plaque psoriasis.


Options:
A: Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4 (Baseline, Week 4)
B: The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously in Patients With Moderate to Severe Chronic Plaque-type Psoriasis With Respect to PASI 75 Achievement After 12 Weeks of Treatment, Compared to Placebo. (13 weeks)
C: Number of Subjects With Physician's Global Assessment of Psoriasis (PGA) of Clear or Almost Clear at Week 16 (Week 16)
D: Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) by Drug Delivery Device (Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)); PK: Area Under the Concentration Time Curve From Time Zero to Last Measured Concentration Value (AUC 0-[Tlast]) by Drug Delivery Device (Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A PHASE 2A, MULTI-SITE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF THE PILOT EFFICACY, SAFETY, AND PHARMACOKINETICS OF 2 OINTMENT FORMULATIONS OF CP-690,550 IN SUBJECTS WITH MILD TO MODERATE CHRONIC PLAQUE PSORIASIS
Brief Summary: The study is being conducted to see whether CP-690,550 ointment has potential as a safe and effective treatment for adult patients with mild to moderate chronic plaque psoriasis.


Options:
A: Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4 (Baseline, Week 4)
B: Change in PASI score from baseline in the two groups (12 weeks)
C: Achievement of 75% or greater improvement from baseline in the Psoriasis Area and Severity Index (PASI) after 12 weeks of double-blind treatment.
D: Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 12 (Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A PHASE 2A, MULTI-SITE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF THE PILOT EFFICACY, SAFETY, AND PHARMACOKINETICS OF 2 OINTMENT FORMULATIONS OF CP-690,550 IN SUBJECTS WITH MILD TO MODERATE CHRONIC PLAQUE PSORIASIS
Brief Summary: The study is being conducted to see whether CP-690,550 ointment has potential as a safe and effective treatment for adult patients with mild to moderate chronic plaque psoriasis.


Options:
A: Percentage of Participants Achieving a 75% Reduction in the Psoriasis Area and Severity Index (PASI75) at Week 12 (Week 12); Percentage of Participants Achieving a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12 (Week 12)
B: Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4 (Baseline, Week 4)
C: Mean Percentage Change From Baseline in the Product of BSA (%) and the sPGA Which is Considered as the Total Psoriasis Severity Index at Week 16 (Baseline to Week 16 (end of phase))
D: Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 at Week 12 (0-12 weeks); Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 (0 - 12 Weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A PHASE 2A, MULTI-SITE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF THE PILOT EFFICACY, SAFETY, AND PHARMACOKINETICS OF 2 OINTMENT FORMULATIONS OF CP-690,550 IN SUBJECTS WITH MILD TO MODERATE CHRONIC PLAQUE PSORIASIS
Brief Summary: The study is being conducted to see whether CP-690,550 ointment has potential as a safe and effective treatment for adult patients with mild to moderate chronic plaque psoriasis.


Options:
A: Percentage of Participants With a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12 (Week 12); Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 (Week 12)
B: Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) Score (PASI90) From Baseline to Week 16 (Baseline, Week 16); Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Week 16); Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52 (Week 52)
C: Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) at Week 24 (Week 24)
D: Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4 (Baseline, Week 4)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Placebo-Controlled, Double-Blind Phase 2 Study of mFOLFOX6 Chemotherapy Plus Ramucirumab Drug Product(IMC-1121B) Versus mFOLFOX6 Plus Placebo for Advanced Adenocarcinoma of the Esophagus, Gastroesophageal Junction or Stomach
Brief Summary: The purpose of this study is to determine whether ramucirumab when used in conjunction with chemotherapy treatment can help participants with stomach, esophagus, and gastroesophageal cancer.


Options:
A: Overall Survival in Patients With Limited Metastatic Gastric Carcinoma: Arm I (12 weeks up to 3 years); Overall Survival in Patients With Limited Metastatic Gastric Carcinoma: Arm II (12 weeks up to 3 years)
B: Overall Survival (From randomization until death, up to 26 months)
C: Overall Survival (OS)- Phase 3 (Date of randomization until death (up to 2 years 3 months)); Overall Survival (OS) - Phase 2 (Dose Selection Portion of the Study) (Date of randomization until death (up to 1 year))
D: Progression-Free Survival (PFS) (Randomization to measured PD or date of death from any cause (up to Month 25.0))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Nebulized Hypertonic Saline for Acute Bronchiolitis in the Emergency Department
Brief Summary: The purpose of this study is to determine whether nebulized 3% hypertonic saline (HS) improves respiratory distress in children 2-23 months presenting to the emergency department (ED) with acute bronchiolitis with persistent respiratory distress after initial therapy with a trial of nebulized albuterol.


Options:
A: length of hospital stay (2 years)
B: Respiratory Assessment Change Score (RACS) (Baseline and 1 hour)
C: Admission Rate (1 day); Length of Stay (1 month); Change in RDAI Score (1 Hour)
D: Length of Stay in the Study-LOS--Intention to Treat Analysis (Time of first study treatment until time of discharge); Length of Stay in the Study-LOS by Per Protocol Analysis (Time of first study treatment until time of discharge)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Nebulized Hypertonic Saline for Acute Bronchiolitis in the Emergency Department
Brief Summary: The purpose of this study is to determine whether nebulized 3% hypertonic saline (HS) improves respiratory distress in children 2-23 months presenting to the emergency department (ED) with acute bronchiolitis with persistent respiratory distress after initial therapy with a trial of nebulized albuterol.


Options:
A: Change in Modified Wood's Clinical Asthma Score (M-WCAS) From Baseline to 240 Minutes (240 Minutes)
B: Respiratory Assessment Change Score (RACS) (Baseline and 1 hour)
C: Successful hospital discharge at three days
D: respiratory clinical score; computerized quantification of wheezing and crackles

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Nebulized Hypertonic Saline for Acute Bronchiolitis in the Emergency Department
Brief Summary: The purpose of this study is to determine whether nebulized 3% hypertonic saline (HS) improves respiratory distress in children 2-23 months presenting to the emergency department (ED) with acute bronchiolitis with persistent respiratory distress after initial therapy with a trial of nebulized albuterol.


Options:
A: compare the rate of admission to hospital between the study and control groups (1 hour after treatment ends)
B: Respiratory Assessment Change Score (RACS) (Baseline and 1 hour)
C: Difference in mean Respiratory Assessment Change Score (RACS) between groups in every time considered (Every 4h for three consecutive times beginning in the moment of inclusion in the study and after every 8h for three consecutive times (average of 36h))
D: Admission rate (24 hours)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Adherence to HAART Using Mobile Phone Text Messages
Brief Summary: The investigators hypothesize that sending weekly motivational text messages to people infected with HIV will encourage them to take their medication, compared to usual care.


Options:
A: Adherence (Change from baseline at 6 months)
B: Plasma HIV-1 viral load (six months)
C: Self-reported completion of a full course of PEP medications and receipt of a final HIV test result from their nPEP provider 12 weeks after the index exposure (12 weeks)
D: Adherence to PrEP (Baseline to Week 48)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Adherence to HAART Using Mobile Phone Text Messages
Brief Summary: The investigators hypothesize that sending weekly motivational text messages to people infected with HIV will encourage them to take their medication, compared to usual care.


Options:
A: Linkage to Care - Participants Who Received Cluster of Differentiation 4 (CD4) T-cell Count Test Result Within 3 Months of Testing HIV-positive (Binary) (3 months); Timely Antiretroviral Therapy (ART) Initiation (Participants Eligible for ART Who Initiate Treatment Within 3 Months of Diagnosis) (3 months); Retention in Care - ART Eligible (Participants Eligible for ART Who Initiated ART and Who Remain on Treatment) (12 months); Retention in Care - Non-ART (Participants Who Return for Repeat CD4 Testing Within 12 Months of Diagnosis) (12 months); Adherence to ART - Objective (Viral Load Test Results <400 Copies/mL) (12 months); Adherence to ART - Subjective (Self-reported Ability to Take ART as Prescribed in Last Month) (12 months)
B: Contraceptive knowledge score (1 year)
C: Biometrically confirmed abstinence (3-6 months); Quitline call rates (1-6 months); Knowledge as measured by survey items (1-6 months)
D: Adherence (Change from baseline at 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Multicentric Trial Comparing Accelerated Partial Breast Irradiation (APBI) Versus Standard or Hypofractionated Whole Breast Irradiation in Low Risk of Local Recurrence of Breast Cancer
Brief Summary: The standard treatment for localized breast cancer is based on conservative surgery (when possible) followed by radiation therapy (RT) delivered to the whole breast. The recommended total RT dose is 45 to 50 Gy delivered in 4.5 to 5 weeks followed by a 10 to 16 Gy boost to the tumor bed for 1 to 1.5 weeks. The rationale for the development of APBI was based on the difficulty for many patients to reach RT centers to receive standard whole breast irradiation (WBI) after conservative surgery. APBI offers decreased overall treatment time and several theoretical advantages over WBI, including a decrease in dose delivered to uninvolved portions of the breast and adjacent organs. If equivalence between the two treatments can be shown, then APBI will be considered as a historic evolution in breast cancer management.

In this phase III trial, designed in postmenopausal women \>50 years of age, the objective is to compare the effectiveness and safety of APBI compared with whole breast irradiation. This study is also designed to ensure high quality criteria for surgery, pathology and RT techniques in the 3 arms and will allow to provide data on economics and costs.


Options:
A: rate of local recurrence (5 years)
B: Number of local relapses (5 YEARS)
C: Local control (5-years, 10 ten-years)
D: Local relapse within the treated breast. (3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 72, 84, 96, 108, 120 months)

Answer: A