TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Adapting Tools to Implement Stroke Risk Management to Veterans
Brief Summary: The purpose of this study is to develop and evaluate the local adaptation of existing stroke prevention tools into practice. A stroke prevention program is a collection of materials including written materials like pamphlets and brochures, videotapes and training guides for stroke survivors and evidence based guidelines for the doctors that provide care for them. Other tools that may be used in a stroke prevention program include devices that help patients monitor medical symptoms at home like home blood pressure machines or blood sugar monitors and messaging devices that allow reporting symptoms from home to a health care provider.

We hypothesized Veterans with stroke who receive the Veteran Stroke Prevention Program would engage in better medication compliance and stroke specific quality of life compared to those who did not receive the program.


Options:
A: Stroke Specific Health Related Quality of Life (6 months for (SSQoL) and 3 months for Perceived Energy Subdomain); Self-Efficacy to Manage Stroke Symptoms (6 months)
B: Care Transition Measure-3 score (CTM-3) (30-days post discharge)
C: Qualitative description of process-related challenges and successes as assessed by observation and survey (3 months)
D: Impact of personalized risk information (baseline); Impact of personalized risk information (3 month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Adapting Tools to Implement Stroke Risk Management to Veterans
Brief Summary: The purpose of this study is to develop and evaluate the local adaptation of existing stroke prevention tools into practice. A stroke prevention program is a collection of materials including written materials like pamphlets and brochures, videotapes and training guides for stroke survivors and evidence based guidelines for the doctors that provide care for them. Other tools that may be used in a stroke prevention program include devices that help patients monitor medical symptoms at home like home blood pressure machines or blood sugar monitors and messaging devices that allow reporting symptoms from home to a health care provider.

We hypothesized Veterans with stroke who receive the Veteran Stroke Prevention Program would engage in better medication compliance and stroke specific quality of life compared to those who did not receive the program.


Options:
A: Recruitment rates (9 months); Patient Satisfaction Scales (9 months); Clinic based Blood Pressure (9 months); Retention rates (9 months)
B: Impact of personalized risk information (baseline); Impact of personalized risk information (3 month)
C: Major vascular event consisting of nonfatal stroke, nonfatal major coronary event and vascular death (Up to 6 years from inclusion)
D: Stroke Specific Health Related Quality of Life (6 months for (SSQoL) and 3 months for Perceived Energy Subdomain); Self-Efficacy to Manage Stroke Symptoms (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: SWiss Multicenter Intracoronary Stem Cells Study in Acute Myocardial Infarction (SWISS-AMI)
Brief Summary: Title: SWiss multicenter Intracoronary Stem cells Study in Acute Myocardial Infarction (SWISS-AMI).

Study population: Patients with acute myocardial infarction, treated with primary PCI.

Objective: To determine whether intracoronary infusion of BMCs improves recovery of left ventricular function after acute myocardial infarction treated by PCI

Design: Multi-center, randomized, controlled clinical trial with central core lab analysis for MRI.

Therapy: Intracoronary infusion of BMCs in the infarct related artery at 5-7 days or 3-4 weeks after successful primary PCI

Primary Endpoint: Change in global left ventricular ejection fraction (LVEF) at 4 months relative to baseline measured by quantitative MRI.

Secondary Endpoints:

* Change in LVEF at MRI at 12 months
* Change in regional left ventricular wall motion and thickness at 4 and 12 months.
* Change in infarct size at 4 and 12 months as assessed by "delayed enhancement" technique by MRI
* Analysis of the myocardial infarct size and transmurality, time to PCI and coronary flow characteristics after PCI as predictor of LV remodeling and change after cell therapy
* Change in myocardial perfusion at 4 and 12 months
* Change in serum level of amino-terminal pro-brain natriuretic peptide (NT pro-BNP)
* Major adverse cardiac events (MACE: death, myocardial infarction, TVR (ACBP or PCI, stroke, hospitalization for cardiac reasons) at 12 months

Interventions:

* Aspiration of 50 ml bone marrow (\<24 hours) prior to administration
* Intracoronary balloon-based infusion of 10 ml BMCs
* Cardiac MRI at baseline (resp. at hospital discharge), at 4 and 12 months

Therapy groups: Bone marrow-derived stem cells infusion in the successfully revascularized infarct related vessel at day 5-7 or day 21-28.

Control group: Management according to the "state of the art" medical therapy after successful primary PCI.

Safety: A study independent "safety committee" will analyze the clinical results after the first 60 patients.


Options:
A: whether intracoronary mBMC transplantation improve LVEF after AMI assessed by ECG-gated SPECT.
B: Cardiac function at 3 and 6 months follow-up will be compared to baseline measures obtained the day(s) before CD34+ cell product infusion. (3 & 6 Months)
C: myocardial flow (MF) (mL/g/min) evaluated by Positron Emission Tomography(PET) with Nitrogen-13 ammonia (13NH3),; Ejection fraction (%) evaluated by 2D echocardiography;
D: Change in global left ventricular ejection fraction (LVEF) at 4 months relative to baseline measured by quantitative MRI (4 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIb, Efficacy, and Safety Study of Rosuvastatin in Children 10-17 Years of Age With Heterozygous Familial Hypercholesterolemia: a 12-week, Double-blind, Randomized, Multicenter, Placebo-controlled Study With a 40-week, Open-label, Follow-up
Brief Summary: The primary objective of this study is to determine the efficacy of once-daily rosuvastatin in reducing LDL-C in children and adolescents aged 10-17 years with HeFH from baseline (Day 0) to the end of the 12-week double-blind treatment period.


Options:
A: Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline (Day 0) to the End of the 12-week Double-blind Treatment Phase (12 weeks)
B: Mean Percent Change in Triglycerides From Baseline to Final Visit (Baseline to 12 Weeks (Final Visit)); Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit (Baseline to 12 Weeks (Final Visit)); Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit (Baseline to 12 Weeks (Final Visit))
C: Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set) (Baseline to 8 weeks)
D: Mean Percent Change in Triglycerides From Baseline to Final Visit (Baseline to 12 Weeks); Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit (Baseline to 12 Weeks); Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit (Baseline to 12 Weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Randomised, Open-labeled, Trial Comparing Sirolimus-Containing Versus mTOR-Inhibitor-Free Immunosuppression in Patients Undergoing Liver Transplantation for Hepatocellular Carcinoma
Brief Summary: The purpose of this study is to determine the safety and efficacy of sirolimus-based immunosuppressive therapy in patients following orthotopic liver transplantation (OLT) for hepatocellular carcinoma (HCC), with regard to HCC recurrence-free patient survival.


Options:
A: Proportion of patients who can significantly decrease the doses of tacrolimus 1 year after transplantation (as defined by: tacrolimus administered on alternate days, or daily with trough levels below 5 ng/mL. (1 year)
B: Recurrence free survival (5 year follow up after last patient in)
C: Event-free survival time at the end of first year after living liver transplantation. (1 year)
D: Estimated Glomerular Filtration Rate (GFR) (month 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Azithromycin Combination Therapy for the Treatment of Uncomplicated Falciparum Malaria in Bangladesh: An Open Label Randomized Controlled Trial
Brief Summary: The purpose of this study is to investigate the efficacy of azithromycin combination therapy with artesunate for the treatment of uncomplicated falciparum malaria in Bangladesh.


Options:
A: Parasitological failure rates; Parasite clearance time; Fever clearance times; Incidence rate of adverse events
B: Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitologic Response (ACPR) at Day 28 in the Modified Intent-to-treat (mITT) Population (Day 28); Percentage of Participants With PCR-corrected ACPR at Day 28 in Per-Protocol (PP) Population (Day 28)
C: Parasitological failure by day 28 (Within 28 days of treatment.)
D: Primary clinical outcome is cure (ACPR as defined by WHO criteria) on Day 42. (42 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase IV Study of Determining the Efficacy of Ampicillin/Sulbactam Combination as Antibiotic Prophylaxis During Breast Cancer Surgery in Patients With a Body Mass Index (BMI) Over 25.
Brief Summary: This is a single center trial to compare the rate of surgical site infection (SSI) in normal (BMI equal to or less than 25; Control Group)) and overweight (BMI over 25) women who are undergoing breast cancer surgery. The overweight patients are further randomized into two groups; in one group patients receive prophylactic antibiotics (ampicillin/sulbactam; Prophylaxis Group), in the other they do not (No Prophylaxis Group).


Options:
A: Surgical Site infection (365 days after the procedure)
B: Drainage volume (7 days)
C: Number of Patients With Body Mass Index (BMI) Over 25 Who Developed Surgical Site Infection (SSI) in Groups Who Received Antibiotic Prophylaxis (Prophylaxis Group) and no Prophylaxis (No Prophylaxis Group). (1 month)
D: Surgical Site Infection (as defined by the Centers for Disease Control and Prevention) (Wounds were assessed on the first post-operative day, then patients were followed-up every week after discharge for the duration of 30 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Laparoscopic Sleeve Gastrectomy or Laparoscopic Proximal Roux-Y-gastric Bypass in the Treatment of Morbid Obesity
Brief Summary: The laparoscopic sleeve-gastrectomy (SG) compared to laparoscopic proximal Roux-Y-gastric bypass (PGB) is as successful in the treatment of morbid obesity in the majority of patients. In case of insufficient weight loss malabsorption can to be added by performing laparoscopic bilious-pancreatic diversion duodenal switch (BPD). The resection of the gastric fundus (LG) leads to changes in gastrointestinal hormones that are possibly different to bypassing the fundus (PGB).


Options:
A: Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6%. (1 year); Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6% With no Diabetes Medications (1 year)
B: effectiveness in terms of weight loss, reduction in co-morbidity and quality of life (5 years)
C: Improvement of co-morbidities (1-year after treatment start)
D: Total Weight Change From Baseline at 12 Weeks in kg (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Cognitive Enhancer May Facilitate Behavioral Exposure Therapy for Veterans With PTSD
Brief Summary: This study will determine whether a combination of virtual reality exposure therapy and D-cycloserine will reduce post-traumatic stress disorder symptoms in Iraq war veterans.


Options:
A: significant reduction in panic symptoms after completion of treatment
B: Snake Questionnaire (SNAQ) (2 weeks)
C: Clinician-Administered PTSD Scale (CAPS) (Baseline); Clinician-Administered PTSD Scale (CAPS) (Posttreatment, 8 weeks); Clinician-Administered PTSD Scale (CAPS) (Month 3); Clinician-Administered PTSD Scale (CAPS) (Month 6); Clinician-Administered PTSD Scale (CAPS) (Month 12)
D: Liebowitz Social Anxiety Scale (LSAS) (Week 13); CGI - Clinical Global Impression of Improvement (Week 13)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Open-label, Long-term Extension Study of Etanercept in the Treatment of Patients With Ankylosing Spondylitis Who Participated in Protocol 16.0037
Brief Summary: The purpose of this study was to evaluate extended safety and efficacy of etanercept in adults with Ankylosing Spondylitis.


Options:
A: Diagnosis of Spondyloarthritis (2 years)
B: Treatment Response (using ASAS criteria) of at least 20% and absolute improvement of at least 10 units on a 0-100 scale in at least 3 of the 4 domains (Up to 4 years); Absence of deterioration (using ASAS criteria) of at least 20% and absolute improvement of at least 10 units on a 0-100 scale in the potential remaining ASAS domain (Up to 4 years)
C: Number of Subjects With a Reduction in Signs and Symptoms as Measured by Assessments of Ankylosing Spondylitis (ASAS) 20 Response at Week 12 (Week 12); Mean Change in the Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) Compared Against a Historical Control Group (Outcomes in Ankylosing Spondylitis International Study [OASIS]) Using the ANCOVA Model Adjusting for Baseline mSASSS Score (Baseline and Week 104)
D: Number of Subjects With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs) (6 month treatment duration)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Family Strengthening in Native Communities Project
Brief Summary: The goals of this study are to evaluate the effects of an in-home parenting education program, called Family Spirit, on parenting knowledge and skills and decreasing alcohol and substance use compared to a breast-feeding education. In addition, we will assess aspects of mother/child interaction.


Options:
A: Sexually transmitted disease (Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum); Rapid repeat pregnancy (Measured at Month 12 postpartum); Sexual risk behavior (Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum); Perinatal outcomes (e.g., birth weight, gestational age) (Measured at Months 6 and 12 postpartum)
B: Iodine deficiency (36 weeks of pregnancy); Iodine deficiency (24 weeks of pregnancy)
C: Improved understanding of preeclampsia (one week)
D: Increase in parent knowledge, measured at baseline, 2 weeks post-partum, 6 months post-partum and 12 months post-partum; Increase in parent skills, measured at baseline, 2 weeks post-partum, 6 months post-partum and 12 months post-partum; Decrease in parental high-risk behaviors, measured at baseline, 2 weeks post-partum, 6 months post-partum and 12 months post-partum; Increase in parental-child involvement, measured at baseline, 2 weeks post-partum, 6 months post-partum and 12 months post-partum

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Family Strengthening in Native Communities Project
Brief Summary: The goals of this study are to evaluate the effects of an in-home parenting education program, called Family Spirit, on parenting knowledge and skills and decreasing alcohol and substance use compared to a breast-feeding education. In addition, we will assess aspects of mother/child interaction.


Options:
A: Increase in parental competence at nine intervals over 39 month study period (birth-3 year postpartum)
B: Increase in parent knowledge, measured at baseline, 2 weeks post-partum, 6 months post-partum and 12 months post-partum; Increase in parent skills, measured at baseline, 2 weeks post-partum, 6 months post-partum and 12 months post-partum; Decrease in parental high-risk behaviors, measured at baseline, 2 weeks post-partum, 6 months post-partum and 12 months post-partum; Increase in parental-child involvement, measured at baseline, 2 weeks post-partum, 6 months post-partum and 12 months post-partum
C: Increase physical activity (2010); Increase the intake of fiber (2010); Decrease fat intake (2010); Decrease television and other screen time (2010); Decrease obesity (2010)
D: Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Baseline (Baseline); Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 1 (1 Year); Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 2 (2 Years); Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 3 (3 Years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Observational, Cross-over Study of the Positive Distending Pressure Generated by Humidified High Flow Nasal Cannula as Compared to Nasal Continuous Positive Airway Pressure
Brief Summary: The specific aims of this study are to evaluate the amount of high flow nasal cannula (HFNC) gas flow required to generate an equivalent positive distending pressure as that provided by nasal continuous positive airway pressure (NCPAP) of 6 cm H2O, assess the relationships between positive distending pressure, gas flow, oxygen requirement, and patient weight, and lastly, develop an appropriate protocol to be used in the NICU for transitioning patients from NCPAP to an equivalent amount of HFNC.


Options:
A: Number of participants with HFNC success (during hospitalization, approximatly 6 days); Number of participants with CPAP/NPPV success (during hospitalization, approximatly 6 days)
B: Number of eligible patients in Group A (step-up) and Group B (step-down) (Baseline); Number of parents/guardians who refuse prospective or deferred consent (Through study completion, an average of 24 hours); Randomising at least 50% of eligible patients (Baseline); Proportion of patients adherent to the study treatment (Through study completion, an average of 72 hours); Mean COMFORT score (72 hours); Number of parents completing the Parental Stressor Scale: PICU (PSS:PPICU) (24 hours)
C: Mean esophageal pressure (3.5 hours)
D: Treatment failure (24 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Observational, Cross-over Study of the Positive Distending Pressure Generated by Humidified High Flow Nasal Cannula as Compared to Nasal Continuous Positive Airway Pressure
Brief Summary: The specific aims of this study are to evaluate the amount of high flow nasal cannula (HFNC) gas flow required to generate an equivalent positive distending pressure as that provided by nasal continuous positive airway pressure (NCPAP) of 6 cm H2O, assess the relationships between positive distending pressure, gas flow, oxygen requirement, and patient weight, and lastly, develop an appropriate protocol to be used in the NICU for transitioning patients from NCPAP to an equivalent amount of HFNC.


Options:
A: Patient comfort (EDIN score) (48 h (CPAP 24 h and HFNC 24 h); cumulative EDIN score for each 24 epoch is calculated and a change between the two interventions are assessed)
B: The percent of infants who will fail NRS and need endotracheal ventilation or will be switched to another mode of NRS. (1 year)
C: Duration of oxygen use (3 months)
D: Mean esophageal pressure (3.5 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Observational, Cross-over Study of the Positive Distending Pressure Generated by Humidified High Flow Nasal Cannula as Compared to Nasal Continuous Positive Airway Pressure
Brief Summary: The specific aims of this study are to evaluate the amount of high flow nasal cannula (HFNC) gas flow required to generate an equivalent positive distending pressure as that provided by nasal continuous positive airway pressure (NCPAP) of 6 cm H2O, assess the relationships between positive distending pressure, gas flow, oxygen requirement, and patient weight, and lastly, develop an appropriate protocol to be used in the NICU for transitioning patients from NCPAP to an equivalent amount of HFNC.


Options:
A: Compare extubation success rate, defined as % infants remaining extubated for > 72 hrs, among infants managed with HHFNC versus nCPAP (72 hrs)
B: Mean esophageal pressure (3.5 hours)
C: Death or Chronic Lung Disease (at 36 weeks postmenstrual age); Death (36 weeks adjusted age)
D: Patient comfort (EDIN score) (48 h (CPAP 24 h and HFNC 24 h); cumulative EDIN score for each 24 epoch is calculated and a change between the two interventions are assessed)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Mechanisms of Erythropoietin Action in the Cardiorenal Syndrome
Brief Summary: Erythropoietin (EPO) treatment in patients with the severe cardiorenal syndrome increases cardiac performance and decreases progression of renal failure by dampening the main driving forces of the cardiorenal syndrome in part via non-erythropoietic pathways.

I. Does EPO administration to patients with the severe cardiorenal syndrome increase cardiac performance and decrease progression of renal disease?

II. Does EPO treatment affect the main driving forces of the cardiorenal connection, that is, dampen the activated renin-angiotensin system (RAS), attenuate increased reactive oxygen species (ROS), normalize increased sympathetic activity, and decrease inflammation?

III. Does EPO treatment positively affect the cell function of patients with the cardiorenal syndrome:

1. are gene expression signatures of leukocytes positively influenced by EPO treatment,
2. does EPO shift the Jak/STAT pathway to a less pro-inflammatory profile in monocytes, and
3. are function and number of endothelial progenitor cells (EPCs) affected by treatment with EPO in the cardiorenal syndrome?

IV. Can the direct actions of EPO be differentiated from the effects on hemoglobin levels?


Options:
A: To establish the therapeutic equivalence of GerEpo with the standard treatment Eprex® for a treatment period of 12 weeks in patients on Hemodialysis with respect to hemoglobin response.
B: changes in gene-arrays, EPC and biomarkers panels (14 days, 6 and 12 months)
C: Mean Change in Hemoglobin (Hb) Concentration From Baseline to Evaluation Period (Baseline, Week 29 to Week 36)
D: The primary outcome will be a composite consisting of mortality (all cause), myocardial infarction, stroke, and CHF hospitalization (not including those hospitalizations during which RRT occurs)

Answer: B