TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: IntegRAted Chronic Care Program at a Specialized Atrial Fibrillation (AF) Clinic Versus Usual CarE in Patients With Atrial Fibrillation, an Investigator-initiated, Prospective, Randomised, Open Label, Blinded Outcome Assessment (PROBE) Controlled Multi-center Study
Brief Summary: Rationale: The treatment of patients with atrial fibrillation is often inadequate due to poor guideline adherence. An integrated chronic care program (ICCP) at a specialized AF-clinic was found to be superior to usual care provided by a cardiologist in terms of cardiovascular hospitalizations and cardiovascular mortality.

Hypothesis: treatment at a specialized AF clinic is superior to usual care in terms of cardiovascular mortality and cardiovascular hospitalizations, cost-effectiveness, quality of life and guideline adherence.

Objectives: primary objective is to show that an ICCP reduces cardiovascular hospitalizations and mortality.

Study design: randomized controlled trial with two study arms: usual care provided by cardiologists (control) versus integrated chronic care program at a specialized AF clinic (intervention) in 8 hospitals in the Netherlands. The RACE4 is an event driven study. A total number of 246 events is needed. In total 1716 patients with newly diagnosed AF will be included. Total duration of the study is 5 years and 10 months with a minimal follow up of 1 year. Data is collected at inclusion, after 3, 6, 12 months, every year thereafter and at the end of the study.

Study population: Patients older than 18 year with newly diagnosed AF.

Intervention: The intervention is delivered through the specialized outpatient AF clinic. The multidisciplinary team at the AF clinic consists of a nurse practitioner or physician assistant or specialised cardiovascular nurse, cardiologist, and is guided by guidelines-based decision support software program based on the applicable ESC guideline recommendations. The use of a web-based patient centered management of patient's own medication (Medication manager TM) was optional. A standardized diagnostic, treatment and follow-up pathway was performed within the ICCP.


Options:
A: Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire (Change from Baseline AFEQT at the 13th week (after the intervention) and 6 months (follow up))
B: The primary endpoint is a composite of unplanned admission to the hospital for any cardiovascular reason and cardiovascular death. (Follow up with minimum of 1 year and a maximum of 5 years and 10 months)
C: Composite of heart failure, thromboembolic complications, bleeding, severe adverse effects of drugs and death from cardiovascular causes. (minimum of 1 year)
D: Time to First Event (Death, Stroke, Major Bleed) (Time to event)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: EVALUATION OF THE PILLCAM™ COLON CAPSULE ENDOSCOPY (PCCE) IN PEDIATRIC ULCERATIVE COLITIS
Brief Summary: This prospective pilot study of 30 pediatric subjects, that are indicated for standard colonoscopy due to follow-up of ulcerative colitis (UC), examines the Given Diagnostic System and the PillCam Colon Capsule in comparison to standard colonoscopy.

This study aims

1. To evaluate and compare the accuracy of PillCam ™ Colon capsule endoscopy (PCCE) with standard colonoscopy in the evaluation of colon in pediatric ulcerative colitis.
2. To evaluate the safety of PillCam ™ Colon capsule endoscopy (PCCE) in pediatric age.


Options:
A: To evaluate and compare the accuracy of PillCam ™ Colon capsule endoscopy (PCCE) with standard colonoscopy in the evaluation of colon in pediatric ulcerative colitis. (Day 3 (after colonoscopy and CCE-2))
B: Rate of clinical remission
C: Change in Mayo score at Day 57 compared with Screening (Day 57)
D: Disease Activity Index score (baseline, week 4)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 1b, Randomized, Double-Blind, Multiple-Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of GS-5816 in Subjects With Chronic Hepatitis C Virus Infection
Brief Summary: The primary objective of the study is to evaluate the safety, tolerability, and antiviral activity of velpatasvir (formerly GS-5816) in HCV treatment naive participants with genotypes 1-6.


Options:
A: Safety Outcome Measures (Safety and tolerability assessments will be performed for a period of 7 days after administration of a single dose)
B: Percentage of Participants Experiencing Treatment Emergent Adverse Events (First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing)); Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities (First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing)); Antiviral Activity of Velpatasvir as Measured by Change in Plasma HCV RNA From Baseline (Baseline; Days 4, 5, 6, 7, 8, 10, and 17)
C: Percentage of Participants Achieving Sustained Viral Response (SVR) at Follow-up Week 24 (FW24) Among Randomized Participants Who Received At Least One Dose of Trial Medication (Up to Week 72)
D: Safety and Tolerability (40 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 1b, Randomized, Double-Blind, Multiple-Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of GS-5816 in Subjects With Chronic Hepatitis C Virus Infection
Brief Summary: The primary objective of the study is to evaluate the safety, tolerability, and antiviral activity of velpatasvir (formerly GS-5816) in HCV treatment naive participants with genotypes 1-6.


Options:
A: Number of Participant Achieving Rapid Virological Response (RVR) at Day 28, Nominal Analysis (Day 28); Number of Participant Achieving RVR at Day 28, (Primary and Supportive Analyses) (Day 28); Probability of Participants With HCV Genotype 1 Achieving RVR At Day 28, Nominal Analysis (Day 28); Probability of Participants With HCV Genotype 1 Achieving RVR at Day 28, Primary and Supportive Analyses (Day 28); Number of Participants With HCV Genotype 1 With Virologic Response (Day 7, 14 and 21); Change From Baseline in HCV Viral Load During 24 Hour (h) Following a Single Dose of GSK2336805 on the Log 10 Scale (Day 1 (Baseline [Pre-dose], 1, 2, 4, 6, and 8 and 24 h)); Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Event (SAE) During Treatment Period (Up to Day 28); Change From Baseline in QTcF Interval at Day 2 and 28 (Baseline (Day 1, Pre-dose ), Day 2 and Day 28)
B: Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12 (A Weeks 4 and 12)
C: Percentage of Participants Experiencing Treatment Emergent Adverse Events (First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing)); Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities (First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing)); Antiviral Activity of Velpatasvir as Measured by Change in Plasma HCV RNA From Baseline (Baseline; Days 4, 5, 6, 7, 8, 10, and 17)
D: Proportion of Participants With Sustained Virologic Response 12 (SVR-12) (12 weeks post-therapy)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Perioperative Selective Decontamination of the Digestive Tract (SDD) in Elective Colorectal Cancer Patients: a Multicenter Randomized Clinical Trial
Brief Summary: The primary objectives of this randomized clinical trial are to evaluate if perioperative SDD can reduce clinical anastomotic leakage rate and its septic consequences as well as other infectious complications. By reduction of septic complications long-term oncological outcome might simultaneously improve.


Options:
A: Surgical Site Infections (30 days)
B: anastomotic leakage and/or abscess (30 days postoperatively)
C: %/type Surgical wound infections rated per infection classifications of NNIS/CDC (with in 30 days post-op)
D: Surgical site infection incidence (30 days after surgery)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The investigators aimed to compare the efficacy of nasal intermittent mandatory ventilation (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant treatment in preterm infants.


Options:
A: Efficacy of nasal intermittent mandatory ventilation (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant treatment in preterm infants (3 months)
B: Trigger Delay (last 5-min of each 15-min trial)
C: Composite of survival to 36 weeks gestational age, free of moderate-severe bronchopulmonary dysplasia (36 weeks gestational age)
D: The percent of infants who will fail NRS and need endotracheal ventilation or will be switched to another mode of NRS. (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The investigators aimed to compare the efficacy of nasal intermittent mandatory ventilation (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant treatment in preterm infants.


Options:
A: Extubation failure (apnea rate and respiratory failure.)
B: Trigger Delay (last 5-min of each 15-min trial)
C: Failure of assignmed non-invasive mode post randomization to NIHFV or BP-CPAP (72 hours)
D: Efficacy of nasal intermittent mandatory ventilation (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant treatment in preterm infants (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The investigators aimed to compare the efficacy of nasal intermittent mandatory ventilation (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant treatment in preterm infants.


Options:
A: Efficacy of nasal intermittent mandatory ventilation (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant treatment in preterm infants (3 months)
B: Death or Chronic Lung Disease (at 36 weeks postmenstrual age); Death (36 weeks adjusted age)
C: need for mechanical ventilation after the procedure (72hours)
D: Survival Without Bronchopulmonary Dysplasia (BPD) (36 weeks); Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery) (55 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Biobehavioral Bases & Management of Metabolic Syndrome
Brief Summary: The metabolic syndrome is increasingly being recognized as a major threat to good health - especially cardiovascular health - and its frequency appears to be increasing in relation to the current epidemic of obesity. The objective of this study is to determine whether a program of enhanced lifestyle intervention can, compared to standard care, reduce the frequency and severity of the metabolic syndrome as assessed by clinical, metabolic, inflammatory and vascular outcome measures. EC will consist of a 17-session structured, lifestyle intervention plan, directed at achieving weight reduction and increasing physical activity change through education, behavior modification and stress management, and conducted in groups. It will comprise a 3-month Core Curriculum of 8 sessions, followed by a Maintenance phase with 9 monthly sessions delivered by lifestyle counselors, experienced in breaking through barriers in working with socioeconomically disadvantaged members of minority groups. All participants will have baseline, 6-monthly and 1-year assessments. This project, Project 2, entitled Community Health Approaches to Reducing Risk in the Metabolic Syndrome (CHARMS), seeks to study psychosocial and behavioral (lifestyle) variables that may contribute to the progression or amelioration of atherosclerotic processes underlying the pathogenesis of coronary heart disease (CHD).


Options:
A: Change From Baseline in Fasting Body Weight (Week 0, Week 56); Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight. (At Week 56); Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight (At 56 weeks); Proportion of Subjects With Onset of Type 2 Diabetes (At 160 weeks)
B: Changes in gene expression in subcutaneous adipose tissue measured by whole genome sequencing (Assessments at baseline (week 0), and after the intervention phase (week 13))
C: Insulin sensitivity (8 weeks)
D: Weight loss (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Monetary Incentive on Survey Response for Vulnerable Children and Youth
Brief Summary: ABSTRACT The purpose of the study is to investigate if a monetary incentive can increase the response rate for vulnerable children and youth in a postal survey. A secondary purpose is to test if monetary incentive has an effect on the content of answers in a postal survey. The study is a randomized controlled trial where participants will be randomly allocated to receive a questionnaire together with a €15 voucher for a supermarket or to only receive a questionnaire. Data are taken from an intervention study aiming at creating network for different groups of vulnerable children and youth aged 8-23 years. The questionnaire survey in the present study is a follow up survey of the original study which are performed 1-2½ years after the participant have left the study. Recruitment to the original study is still ongoing and the investigators expect the total participation to be around 250. In the primary analysis the investigators will estimate the relative risk (RR) to assess whether there is a difference between group allocation and questionnaire response rate. The investigators will adjust for age in the analysis. In the secondary analyses the investigators will test whether scores on the five SDQ scales are different between group allocations. The investigators will adjust for the covariates age and gender, since the scores may depend on age and gender (4).


Options:
A: Overall response rate (Up to 3 months (from February 3 2017 to maxium Maj 5 2017))
B: Proportion of individuals receiving a standardized program of pretest education who then proceed to genetic testing (Up to 1 year); Proportions of individuals who choose to receive the results through their primary care providers or through the study-provided expert staff (Up to 1 year); Psychosocial impact of genetic population screening utilizing a digital health solution (Up to 1 year); Facilitators and barriers to engaging primary care providers (PCPs) in the BRCA1/2 results disclosure process (Up to 1 year); Participant health updates in personal familial cancer diagnosis and genetic testing depending on method of results communication (Up to 1 year)
C: Knowledge of Consent Information (At baseline (time zero))
D: Response rate (up to 10 weeks after receiving the questionnaire)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effectiveness of a Need-based Nutritional Intervention Strategy to Improve the Nutritional Status of Elderly Nursing Home Residents
Brief Summary: To examine the effectiveness of a "need-based nutritional intervention" strategy in improving the nutritional and physical functional status of nursing home elderly.


Options:
A: Assessment of nutritional status with the Mini nutritional Assessment (MNA) (Baseline and every 4 weeks, up to 24 weeks)
B: survival free of an abnormal diet at 6 months
C: cognitive decline (33 months)
D: The primary outcome measure is Quality of Life (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: ADVANCE THERAPY ASPERGILLOSIS INVASIVE IN PATIENTS HIGH RISK ONCOHEMATOLOGICAL PCR USING FOR EARLY DETECTION OF ASPERGILLUS
Brief Summary: ADVANCE THERAPY ASPERGILLOSIS INVASIVE BY PCR DETECTION


Options:
A: Efficacy of PCR technique for detection of Aspergillus DNA versus the standard technique for the determination of galactomannan Antigen (AGA) in serum (18-20 months)
B: Calculation of sensitivity, Specificity, positive predictive value, negative predictive value and diagnostic odds ratio (3 months)
C: The proportion of patients treated with at least 1 course of empiric antifungal therapy as per protocol definition at 26 weeks following randomisation (26 weeks of follow-up)
D: Prevention of possible, probable or proven fungal infection. (Completion of Induction Chemotherapy or successful recovery of ANC > 1000/mm3)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Strategies and Opportunities to Stop Colon Cancer in Priority Populations
Brief Summary: Only an estimated 50 million US adults aged 50-75 are up-to-date on colorectal cancer (CRC) screening according to guidelines set by the federal government. CRC is 90% curable with timely detection and appropriate treatment of precancerous polyps; increased screening could reduce incidence by up to 50%. Groups least likely to undergo screening, those with minimal education, low income, low access to health care, recent immigrants or Hispanics, are the same people who frequently receive care at Federally Qualified Healthcare Center's (FQHCs). The use of fecal occult blood tests (FOBT) and fecal immunochemical tests (FIT) is exceedingly low in FQHCs (7-9% of patients in the past year) and far below national averages and target rates. Our results will provide valuable information on how to use electronic health record (EHR) resources to optimize guideline-based screening in FQHC clinics whose patient populations have disproportionately low CRC screening rates.

This project, in conjunction with the research team, will use an advisory panel to direct the research activities. The advisory panel will be made up of clinicians, leaders, researchers, and patients. The panel and team will guide the development of materials, the outreach to patients, and the research protocol to best reach FQHC patients who are due for colorectal cancer screening.

This project will be conducted in two phases, Phase I is conducting a pilot at two FQHC's, and Phase II is rolling out the intervention to between 20-30 clinics.


Options:
A: Individual Physical Function and Mental Health domains from SF-36 (for participants who complete the phone surveys); 6-minute walk distance and memory evaluation (for participants who attend the study visits) (Measured at Months 6 and 12)
B: Change in dietary and physical activity behavior (self-report) (Baseline to 8 weeks later)
C: FIT Completion (Completed FIT kits sent back within 12 months)
D: Proportion of respondents who will complete the 3-month follow-up (Finish all telephone survey by Jan 2018)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-Blind Switch Study of Vilazodone in the Treatment of Major Depressive Disorder Following Partial Response to or Inability to Tolerate a Generic SSRI
Brief Summary: The purpose of this study is to evaluate the safety and effectiveness of vilazodone for the treatment of major depressive disorder versus citalopram. Doctors want to determine if vilazodone is effective for the treatment of major depressive disorder in those who have not responded to generic selective serotonin reuptake inhibitors (SSRI), which is a class of anti-depressant drugs such as Prozac, Lexapro, Paxil, or Zoloft. Both vilazodone and citalopram have been approved for the treatment of major depressive disorder. This research is being done because the researchers want to find out if vilazodone works in reducing the symptoms of depression significantly more than a generic SSRI.


Options:
A: Montgomery-Åsberg Depression Rating Scale (MADRS) (Baseline and final MADRS scores during the double-blind phase.)
B: Change From Baseline (End of Phase A [Week 8]) to Week 14 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score for the Efficacy Sample. (Baseline and Week 14); Change From Baseline (End of Phase A [Week 8]) to Week 14 in MADRS Total Score for the Efficacy Sample Per the Final Protocol. (Baseline and Week 14)
C: Change in Total MADRS Scores From Baseline to Week 8 (Baseline, Week 8); Change in the Discontinuation Emergent Signs and Symptoms Check List (DESS) (Baseline, week 9); Change in Safety as Assessed by the Arizona Sexual Experience Scale (ASEX) (Baseline, Weeks 8)
D: Mean Change From the End of Phase A (Week 8 Visit) to Phase B (Week 14 Visit) in the Montgomery-Asberg Depression Rating Scale for the Efficacy Sample Set (Baseline and Week 14); Mean Change in MADRS Total Score From Baseline End of Week 8 to Week 14 for the Efficacy Sample Per Final Protocol (Baseline and Week 14)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pharmacist Intervention Programme in Secondary Care to Improve Medication Adherence in Patients With Hypertension
Brief Summary: Patients with hypertension have an increased risk of stroke and myocardial infarction. However, poor adherence to treatment with antihypertensives and lipid-lowering agents occurs frequently within this patient group. The purpose of this study is to investigate whether a complex tailored intervention in a hospital setting will lead to increased medication adherence and fewer cardiovascular events when compared to a usual care group. Interventions focus on motivational interviewing, medication review and telephone follow up.


Options:
A: Primary composite endpoint combined with: - Percentage of all-cause mortality - Percentage of Unplanned hospital admission - Percentage of Emergency visits. - Percentage of Institutionalization (At 12 months)
B: Percent of patients that are at least 80% adherent (Medication possession rate > 0.8) to antihypertensives and statins (One year from inclusion)
C: Change in proportion of pills taken compared to baseline (0-2months) at 8months; Between-group comparison of medication persistence at 14months
D: Success Rate of standard medical management (1 year after enrolled)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pharmacist Intervention Programme in Secondary Care to Improve Medication Adherence in Patients With Hypertension
Brief Summary: Patients with hypertension have an increased risk of stroke and myocardial infarction. However, poor adherence to treatment with antihypertensives and lipid-lowering agents occurs frequently within this patient group. The purpose of this study is to investigate whether a complex tailored intervention in a hospital setting will lead to increased medication adherence and fewer cardiovascular events when compared to a usual care group. Interventions focus on motivational interviewing, medication review and telephone follow up.


Options:
A: Blood pressure control (Measured by zero blood pressure measurements at baseline and 2, 4, 6, 8, and 9 months)
B: 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)
C: Percent of patients that are at least 80% adherent (Medication possession rate > 0.8) to antihypertensives and statins (One year from inclusion)
D: systolic blood pressure (6 months)

Answer: C