TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy/Effectiveness of Unhealthy Drug Use Screening/Brief Intervention Models
Brief Summary: The objective of this study is to test whether screening and brief intervention for drug use among primary care patients leads to improved drug-related outcomes (such as decreased drug use and consequences).


Options:
A: Drinks per drinking day (6 months); Rate of effective contraception (6 months)
B: Substance use and function questionnaire (2 years)
C: Linkage to Alcohol Behavioral Therapy Counseling (i.e., "Aftercare") (1 month)
D: Drug use (Six Months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Exacerbation and Training - Study; a Randomized Controlled Study of the Effect of Resistance Training in Acute Exacerbations of COPD
Brief Summary: When patients with chronic obstructive lung disease (COPD) are admitted to the hospital with a severe exacerbation they lose muscle strength. This muscle weakness predisposes these patients to further hospital admissions. Resistance training is a potent countermeasure to prevent and treat muscle weakness. In the setting of an acute exacerbation this intervention however has not been validated.

The present study aims at investigating the safety and efficacy of resistance training (3x8 quadriceps extensions per day) to prevent muscle weakness. End points are quadriceps muscle strength and hospital readmission and functional status at discharge. Using the minimally invasive needle muscle biopsy technique described by Bergström the effects of resistance training on the skeletal muscle will be analyzed in detail.

After giving informed consent, patients will be randomized on admission into usual care or usual care plus resistance training. Patients will be followed-up using the clinical pathway for COPD (10 days). After one month patients will attend the outpatient clinic for a follow-up visit. Besides the measurement prescribed in the clinical path for COPD (including arterial blood gas measures, lung function, functional investigation of the patients), patients will undergo muscle strength measures and venous blood will be drawn for the analysis of systemic inflammatory and growth factors. Half of the patients will receive a resistance training program. At the end of the hospital admission, a needle biopsy of the vastus lateralis muscle will be obtained.


Options:
A: Change from baseline in dyspnea at 4th day (At baseline and at the 4th day of the study)
B: Reduction in the decline of muscle force during the exacerbation. (discharge Day 9)
C: Non-outpatient COPD related hospital attendance (A+E attendance, inpatient admission or death) (3-months)
D: To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of COPD related re-hospitalizations in the intervention versus the control group . (12 months); To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of the composite outcome, COPD related hospitalizations or death in the intervention versus the control group. (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Exacerbation and Training - Study; a Randomized Controlled Study of the Effect of Resistance Training in Acute Exacerbations of COPD
Brief Summary: When patients with chronic obstructive lung disease (COPD) are admitted to the hospital with a severe exacerbation they lose muscle strength. This muscle weakness predisposes these patients to further hospital admissions. Resistance training is a potent countermeasure to prevent and treat muscle weakness. In the setting of an acute exacerbation this intervention however has not been validated.

The present study aims at investigating the safety and efficacy of resistance training (3x8 quadriceps extensions per day) to prevent muscle weakness. End points are quadriceps muscle strength and hospital readmission and functional status at discharge. Using the minimally invasive needle muscle biopsy technique described by Bergström the effects of resistance training on the skeletal muscle will be analyzed in detail.

After giving informed consent, patients will be randomized on admission into usual care or usual care plus resistance training. Patients will be followed-up using the clinical pathway for COPD (10 days). After one month patients will attend the outpatient clinic for a follow-up visit. Besides the measurement prescribed in the clinical path for COPD (including arterial blood gas measures, lung function, functional investigation of the patients), patients will undergo muscle strength measures and venous blood will be drawn for the analysis of systemic inflammatory and growth factors. Half of the patients will receive a resistance training program. At the end of the hospital admission, a needle biopsy of the vastus lateralis muscle will be obtained.


Options:
A: Hospital mortality (during hospitalization)
B: Number of patients returning to independent functional status: defined as ability to perform 6 activities of daily living (ADL's)(bathing, dressing, eating, grooming, transfer from bed to chair, toileting) and independent ambulation (Hospital Discharge)
C: Reduction in the decline of muscle force during the exacerbation. (discharge Day 9)
D: Diagnosis of CIPNM (June 2009)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The RNA (RNA-Based Noninvasive Aneuploidy) Study
Brief Summary: The study will examine the sensitivity and specificity of a circulating cell-free nucleic acid test (DNA/RNA) to identify Down syndrome between about 10 weeks and 21 weeks 6 days gestation. In addition, the new test may be used to identify trisomy 13 and 18 as part of a more complete laboratory developed test. We hypothesize that the new circulating cell-free fetal NA-based test will accurately and precisely measure specific fetal markers in maternal circulation and that measurement will lead to the ability to noninvasively identify with high sensitivity and specificity, fetal chromosome abnormalities, such as Down syndrome.


Options:
A: Classification of fetal status as affected or not affected for Trisomy 21 based on Artemis Health Test on maternal blood. (10 months)
B: Comparison of screen positive rates between investigational testing results and conventional screening results (standard of care). (12 months)
C: Difference in sensitivity and specificity of Ariosa Harmony™ Prenatal Test (AUCt) and combined first-trimester screening for detection of T21. (Enrollment to delivery)
D: The RNA study is an observational trial whose primary aim is to document the performance (sensitivity and specificity) of a laboratory developed test (LDT), using fetal nucleic acid in maternal plasma to identify Down syndrome in early pregnancy. (Within 1st and 2nd trimesters)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to evaluate the effects of Remote Ischemic Preconditioning on cognitive function in patients undergoing cardiac surgery compared to control intervention.


Options:
A: Composite structural and functional neurological outcome (7 days)
B: Composite of all-cause mortality, non-fatal myocardial infarction, any new stroke, and/or acute renal failure (In-hospital)
C: The primary outcome measure is postoperative neurocognitive dysfunction. (Preoperative, 1 week and 3 months after surgery)
D: Major adverse cardiac and cerebral events (One year post-surgery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Brief Intervention in Primary Care for Problem Drug Use and Abuse
Brief Summary: This study will examine the effectiveness of a brief intervention in a primary care setting to reduce drug use or abuse compared to enhanced care as usual.


Options:
A: Number of cannabis-abstinent days in past month (Baseline, 6 months, 10 months)
B: Use of illicit drugs in the past 30 days (baseline, 3, 6, 9, and 12 months); Enrollment in formal substance abuse treatment (baseline up to 2 years post-intervention); Medical, legal, employment, social, and psychiatric outcomes (baseline, 3, 6, 9, and 12 months)
C: the number of joints consumed per month (at 12 months)
D: abstinence, defined as no evidence of cannabis use during the past 4 weeks as evidenced by self report and a negative urine screen; number of times a cannabis product was used in the past 4 weeks; retention rate (at the end of treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Controlled, Parallel-group, 12-week Study to Compare the Efficacy and Safety of the Combination of Indacaterol 150 µg Once Daily With Open Label Tiotropium 18 µg Once Daily Versus Open Label Tiotropium 18 µg Once Daily in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease
Brief Summary: This study assessed the efficacy and safety of indacaterol (150 µg once daily \[od\]) when combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients with chronic obstructive pulmonary disease (COPD).


Options:
A: Mean Change From Baseline (BL) in Aortic Pulse Wave Velocity (aPWV) at the End of the 12-week Treatment Period (Day 84) (Baseline to Day 84 (Early Withdrawal))
B: Part A: Morning Predose (Trough) Forced Expiratory Volume in 1 Second (FEV1) (Change from baseline (Week 0) to Week 12); Part B: Morning Predose (Trough) FEV1 (Change from baseline (Week 0) to 52 Weeks)
C: Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Placebo (Baseline and 6 weeks)
D: Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose at the End of the Study (Week 12, Day 84) (From 5 minutes to 8 hours post-dose at the end of the study (Week 12, Day 84))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Controlled, Parallel-group, 12-week Study to Compare the Efficacy and Safety of the Combination of Indacaterol 150 µg Once Daily With Open Label Tiotropium 18 µg Once Daily Versus Open Label Tiotropium 18 µg Once Daily in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease
Brief Summary: This study assessed the efficacy and safety of indacaterol (150 µg once daily \[od\]) when combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients with chronic obstructive pulmonary disease (COPD).


Options:
A: Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85) (24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85))
B: Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment (after 12 weeks)
C: Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment (Week 12)
D: Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose at the End of the Study (Week 12, Day 84) (From 5 minutes to 8 hours post-dose at the end of the study (Week 12, Day 84))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Does Vaccinating Health Hutterite Children Against Influenza Prevent Influenza in Other Hutterite Colony Members: A Randomized Cluster Trial
Brief Summary: The goal of this randomized clinical trial is to determine whether immunizing children in Hutterite colonies with inactivated influenza vaccine can prevent influenza and its complications in other colony members. Furthermore, the study will assess the indirect benefit to Hutterites at high risk of complications. The study is a blinded, cluster randomized controlled trial among Hutterite colonies to test the hypothesis that high immunization rates (\>70%) of healthy children with inactivated influenza vaccine reduces transmission of influenza to other colony members. Randomization of these homogeneous, moderately sized colonies where there is regular spread facilitated by a communal lifestyle, but limited re-introduction because of relative isolation from outside community, represents a unique opportunity to test the hypothesis of indirect benefit under close to ideal conditions. The primary outcome will be laboratory-confirmed influenza. Secondary outcomes include influenza-like illness, otitis media, physician visits, antimicrobial prescriptions, absenteeism, lower respiratory tract infection, hospitalizations, and death.


Options:
A: laboratory-confirmed influenza infection (Dec to June each year for 3 years)
B: Number of Participants With Fever Post Dose 1 (Days 1-8), Defined as an Oral Temperature ≥ 101°F (38.3°C). (Days 1-8); Number of Participants Who Experienced a Post Dose 1 (Day 15) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus (Day 1, Day 15); Number of Participants Who Experienced a Post Dose 1 (Day 29) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus (Day 1, Day 29); Number of Participants Who Experienced a Post Dose 2 (Day 57) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus (Day 1, Day 57)
C: Number of Participants With Fever Post Dose 1 (Days 1-8), Defined as an Axillary Temperature ≥ 101°F (38.3°C). (Days 1- 8); Number of Participants Who Experience a Post Dose 1 (Day 15) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus (Day 1, Day 15); Number of Participants Who Experience a Post Dose 1 (Day 29) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus (Day 1, Day 29); Number of Participants Who Experience a Post Dose 2 (Day 57) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus (Day 1, Day 57)
D: The primary endpoint for efficacy is the first episode in the first season in a study child of a culture-confirmed influenza illness, caused by community-acquired subtypes antigenically similar to those contained in the vaccine.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Double-Blind, Multi-Center, Placebo-Controlled, Randomized Withdrawal, Safety and Efficacy Study of SPD489 in Adults Aged 18-55 With Attention-Deficit/Hyperactivity Disorder (ADHD)
Brief Summary: The primary objective of this study is to evaluate the maintenance of efficacy, as measured by Adult ADHD Rating Scale with Prompts (Adult ADHD-RS with prompts) and Clinical Global Impression - Severity (CGI-S) scores, through a randomized withdrawal design when subjects with ADHD have been on stable treatment with commercial SPD489 for a minimum of 6 months and are maintained on their screening dose of commercial SPD489.


Options:
A: Change From Baseline in Subject-reported Behavior Rating Inventory of Executive Function - Adult Version Global Executive Composite T-score (BRIEF-A GEC T) at up to 10 Weeks (Baseline and up to 10 weeks)
B: Clinician-administered ADHD-rating scale (ADHD-RS) performed using adult DSM-IV prompts (weekly over a period of 4 weeks)
C: Attention Deficit Hyperactivity Disorder- Rating Scale (ADHS-RS) (12 weeks)
D: Percent of Treatment Failures at up to 6 Weeks (Up to 6 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Follow-up Study to Evaluate the Long-term Immunogenicity and Safety of a HPV Vaccine (GSK 580299) in Healthy Female Subjects
Brief Summary: Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. This study is designed to evaluate the long-term immunogenicity and safety of the 580299 HPV vaccine up to 10 years after administration of the first dose of HPV vaccine (Month 0) administered in the primary study 580299/013. This protocol posting deals with objectives \& outcome measures of the extension phase from Month 60 to Month 120. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT00196924). The objectives \& outcome measures of the extension phase up to Month 48 are presented in a separate protocol posting (NCT00316706).


Options:
A: HPV-6 Antibody Level (Geometric Mean Titer of HPV-6) (Week 28); HPV-11 Antibody Level (Geometric Mean Titer of HPV-11) (Week 28); HPV-16 Antibody Level (Geometric Mean Titer of HPV-16) (Week 28); HPV-18 Antibody Level (Geometric Mean Titer of HPV-18) (Week 28)
B: Measurable antibody mediated neutralisation of HPV serotype 6, 11, 16, 18 and genetically related serotypes, especially 45 (18 months from enrollment)
C: Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values. (At Month 60); Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values. (At Month 72); Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values. (At Month 84); Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values. (At Month 96); Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers (At Month 60); Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers (At month 72); Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers (At Month 84); Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers (At Month 96); Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values. (At Month 108); Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers (At Month 108); Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers (At Month 120); Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values. (At Month 120)
D: Incidence of the Composite Endpoint of Human Papillomavirus (HPV) 16/18-related Cervical Intraepithelial Neoplasia (CIN) 2 or Worse in the Base Study (Up to 4 years); Incidence of the Composite Endpoint of Human Papillomavirus (HPV) 16/18-related Cervical Intraepithelial Neoplasia (CIN) 2 or Worse in the Long-term Follow-up (LTFU) Study (Up to 14 years since Vaccine Dose 1); Incidence of the Composite Endpoint of HPV16/18-related CIN 2 or Worse in the Long-term Follow-up (LTFU) Study (up to 22 years post Vaccination Dose 1)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitive Behavioral Therapy for Depression After Traumatic Brain Injury
Brief Summary: The purpose of this study is to test the effectiveness of a telephone-based and in-person Cognitive Behavioral Therapy (CBT) intervention for treating Major Depressive Disorder (MDD) following Traumatic Brain Injury. Participants are randomly assigned to receive one of the following: 1) Telephone-based CBT, 2) In-person CBT, or 3) Usual care (control).


Options:
A: Beck Depression Inventory - II (Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.)
B: Hamilton Rating Scale for Depression (HAM-D) (16 weeks, 24 weeks); Symptom Checklist-20 (SCL-20) (16 weeks, 24 weeks)
C: Measure: two composite measures - post-traumatic symptoms that develop or worsen after the injury - general health status (Six months)
D: Remission of depression (DSM-IV diagnosis no longer met) (baseline); Remission of depression (DSM-IV diagnosis no longer met) (one week after treatment completion); Remission of depression (DSM-IV diagnosis no longer met) (six months after treatment completion); Remission of depression (DSM-IV diagnosis no longer met) (one year after treatment completion)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Trial to Assess Catheter Ablation Versus Rate-Control in the Management of Persistent Atrial Fibrillation in Chronic Heart Failure
Brief Summary: It is still uncertain what the best treatment is for patients who have both atrial fibrillation (AF) and heart failure. The aim of the study is to help identify the optimal treatment for patients with these two significant medical conditions. This will be performed by comparing two alternative strategies for AF management: catheter ablation (to restore normal rhythm) and medical therapy (to control heart rate, but not aiming ro restore normal rhythm). After random assignment, the effect of each strategy will be assessed by looking for changes in exercise capacity, symptoms, heart pump function, and quality of life during 12 months of follow-up.


Options:
A: Peak oxygen consumption at cardiopulmonary exercise test (12 months)
B: Survival Free of Atrial Fibrillation (6 -12 months)
C: Difference in ejection fraction between groups (6 months)
D: Change in Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)% (baseline and 6 months); Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI) (Baseline); Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)at 6 Months (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Alberta Clinical Trial in Optimizing Hypertension: The RxAction Study
Brief Summary: The purpose of this study is to evaluate the effect of enhanced pharmacist care (patient identification, assessment, education, prescribing/titration of antihypertensive medications and close follow-up) on systolic blood pressure (BP) reduction in patients with poorly controlled hypertension in the community setting.


Options:
A: The difference in change in estimated cardiovascular risk between advanced care and usual care groups (3 months)
B: *change in mean diastolic, systolic, and combined diastolic and systolic BP.; *percent of patients with adequately controlled BP.
C: difference in change in systolic BP between the intervention and usual care groups (6 months)
D: Comparison of difference in change in systolic BP between enhanced care and usual care (24 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Alberta Clinical Trial in Optimizing Hypertension: The RxAction Study
Brief Summary: The purpose of this study is to evaluate the effect of enhanced pharmacist care (patient identification, assessment, education, prescribing/titration of antihypertensive medications and close follow-up) on systolic blood pressure (BP) reduction in patients with poorly controlled hypertension in the community setting.


Options:
A: Evaluate the effect of the pharmaceutical intervention on the disease control, treatment adherence and patient knowledge of his/her medication using the MEF, treatment adherence and patient knowledge of the medication indicators. (First a Pilot in 3 months and then the final study in 6 months)
B: Knowledge of Asthma (6 months after the first evaluation)
C: Comparison of difference in change in systolic BP between enhanced care and usual care (24 weeks)
D: Complete discontinuation of the targeted potentially inappropriate medication (e.g. benzodiazepines, oxybutynin) (6 months post-intervention)

Answer: C