araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 63-year-old female with aortic aneurysm; genetic feature: ACTA2

Clinical trial: Endurant™ Stent Graft System in the Treatment of Infra-renal Abdominal Aortic Aneurysms (ENDURANT France)

Summary: The purpose of this study is to assess the benefits of endovascular repair with Endurant Stent Graft System by documenting overall mortality, complications, the rate of conversion to open surgical repair, and the development and rupture of the aneurysm on a long term, i.e. at 5 years, in a cohort of patients representative of the population treated under real-life conditions of use in France.

Detailed description: Data regarding the use under routine practice of abdominal aortic stent grafts in France are expected by the French National Authority for Health (HAS). Therefore, in its opinion report from July 13, 2010, HAS makes the maintenance of reimbursement approval of each stent graft dependent on the presentation of results of a specific follow-up study carried out in a cohort of patients representative of the French population treated under real-life conditions of use. This prospective cohort study must involve at least 150 patients implanted after registration on the LPPR (List of Products and Services qualifying for Reimbursement). The results of the follow-up study must be forwarded to the National Committee for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) for examination once a year. The assessment of this follow-up could lead to the recommendation by CNEDiMTS to continue or stop the reimbursement of the concerned stent graft.
  In France, The Endurant™ Stent Graft System is registered on the LPPR for a period of 3 years since September 13, 2011. In order to comply with HAS expectations, Medtronic Bakken Research Center is setting up this long term non-interventional study on the Endurant stent graft.

Eligibility: Inclusion Criteria:
  -  Patient with age ≥18 years, who is able to understand the information given by the investigator regarding the collection and release of his/her personal information and who is able to oppose to this collection and release.
  -  Any patient requiring placement of an abdominal aortic stent graft for the treatment of a non-ruptured infra-renal abdominal aortic aneurysm.
  -  Patient not opposed to the collection and release of his/her personal information
  -  Intention of physician to implant electively the Endurant™ Stent Graft System
  Exclusion Criteria:
  -  Patient in whom clinical follow-up will not be possible i.e. patient not able to come back for follow-up visits (ex. patient living abroad)

Relevance to patient case: not relevant
Patient case: 63-year-old female with aortic aneurysm; genetic feature: ACTA2

Clinical trial: Zenith® Spiral-Z® AAA Iliac Leg Graft Post-market Registry

Summary: The purpose of this registry is to obtain case reports of physician experience with the Spiral-Z® graft under routine clinical care.


Eligibility: Inclusion Criteria:
  -  Patient is implanted with Zenith® Spiral-Z® AAA Iliac Leg Graft.
  Exclusion Criteria:
  -  Patients for whom this device would not normally be considered standard of care.

Relevance to patient case: not relevant
Patient case: 63-year-old female with aortic aneurysm; genetic feature: ACTA2

Clinical trial: Studying Gene Expression in Samples From Younger Patients With Neuroblastoma

Summary: RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors find better ways to treat cancer.
  PURPOSE: This research trial studies gene expression in samples from younger patients with neuroblastoma.

Detailed description: OBJECTIVES:
  -  Determine whether TβRIII expression and TGF-β signaling decrease in advanced-stage neuroblastoma (NBL) and whether these changes are confined to the Schwannian stroma.
  -  Determine whether sTβRIII levels and TGF-β signaling correlate with NBL stage, tumor stroma content, surface TβRIII expression, and TGF-β signaling.
  OUTLINE: Archived paraffin-embedded tissue and plasma samples are analyzed for TβRIII expression, TGF-β signaling, and SMAD3 expression and phosphorylation by immunohistochemistry, enzyme-linked immunosorbent assay (ELISA), and other assays. Surface expression of TβRIII in the neuroblastic and stromal tumor components are correlated with matched circulating levels of soluble TβRIII. Results are then correlated with each patient's outcome data, including stage.

Eligibility: DISEASE CHARACTERISTICS:
  -  Tissue samples and matched plasma samples available from 1 of the following groups:
  -  Patients with low-stage (International Neuroblastoma Staging System [INSS] stage 1 or 2) neuroblastoma (NBL)
  -  Patients with advanced-stage (INSS stage 3 or 4) NBL
  -  Patients with stage 4S NBL
  -  Clinical and/or outcome data associated with the tissue and plasma samples including INSS stage, age, MYCN amplification status, chromosomal alterations, and 5-year survival, if known
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 63-year-old female with aortic aneurysm; genetic feature: ACTA2

Clinical trial: Prospective Follow-up Study of the Aortic Diameter in Patients With Giant Cell Arteritis

Summary: Giant cell arteritis (GCA) is the most frequent vasculitis in patients above 50 years of age. The disease has limited mortality, mostly due to the development of aortic aneurysms, leading to dissection and rupture. The probability to develop this complication is 17 x higher at the level of the thoracic aorta and 2,4 x at the level of the abdominal aorta in patients with GCA when compared with a control group. Therefore, follow-up of the aortic diameter in patients with GCA is part of good clinical practice. Previous retrospective research showed a link between FDG-uptake at the level of the thoracic aorta, on positron-emission-tomography (PET) at the time of diagnosis, and the increase of diameter and volume of the thoracic aorta during follow-up (on computed tomography (CT)).
  The purpose of this prospective study is to follow-up on the aortic diameter, and to correlate these measures with FDG-PET uptake at diagnosis. Ideally, this would allow us to define a group of patients at high risk to develop an aortic aneurysm, already at the time of diagnosis.

Detailed description: As standard care, all patients with a suspicion of GCA undergo a biopsy of the temporal artery and a PET scintigraphy to evaluate the presence of large vessel vasculitis. Patients with proven GCA on biopsy and/or scintigraphy undergo a computed tomography (CT) of the aorta without the administration of contrast, at diagnosis and yearly thereafter (every 12 +/- 3 months) for 10 years.
  Measurements include the diameter of the ascending aorta, aortic arch, descending aorta, suprarenal, juxtarenal and infrarenal aorta, and the volume of the thoracic and the abdominal aorta. These measurements are correlated with FDG-uptake at the level of the aorta on PET-scintigraphy at the time of diagnosis. All patients will be treated according to accepted guidelines and standard care in our center (methylprednisolone started at 32 mg/day, with slowly declining doses until stop after 1 to 1,5 years of treatment).

Eligibility: Inclusion Criteria:
  -  patients with a first episode of biopsy and/or scintigraphy proven giant cell arteritis
  -  patients with a previous diagnosis of giant cell arteritis, in whom a yearly computed tomography of the aorta is available can opt to participate in this study
  -  informed consent form has to be signed by all patients
  Exclusion Criteria:
  -  patients already treated with steroids before performance of PET-scintigraphy
  -  earlier episodes of giant cell arteritis, without documentation of the aortic diameter at that moment

Relevance to patient case: not relevant
Patient case: 63-year-old female with aortic aneurysm; genetic feature: ACTA2

Clinical trial: Screening Cardiovascular Patients for Aortic Aneurysms

Summary: Screening studies for Abdominal Aortic Aneurysms (AAA) in 65 to 79 years aged men, have shown a significant reduction in AAA related mortality. In addition, the cost-effectiveness of screening for AAA in men in the Netherlands has been demonstrated by using a Markov model. Screening might be even more (cost-) effective if targeted on high risk groups, such as patients with a particular cardiovascular disease with a known increased risk of having an AAA.
  Project SCAN (Screening CardioVascular patients for Aortic aNeurysms) is a project focused on targeted AAA screening to proactively diagnose patients at high risk of having an aneurysm that eventually may rupture. This pilot project aims to study the value of a screening protocol in daily practice to detect AAA's in high risk patients.

Detailed description: 1. Offering PAD and CAD patients a non-invasive abdominal ultrasound after a careful process of shared-decision making
  2. Recording data on aneurysm detection on all PAD and CAD patients screened:
  1. General information (age, gender)
  2. Medical history on CardioVascular risk factors (such as smoking history, hypertension, and other cardiovascular medical conditions - only information that is already recorded in the patient's medical history chart)
  3. AAA - Yes/ No (Yes if ≥3 cm AAA)
  4. If ≥3 cm aneurysm, record exact size and outcome in time (surveillance, treatment, no treatment)
  5. If treated, record treatment type (EVAR or Open) and outcome

Eligibility: Inclusion Criteria:
  -  male and female patients
  -  peripheral arterial disease (ankle brachial index < 0,90 and/or reduction of > 0.15 after exercise test) or a carotid stenosis (stenosis ≥ 50%)
  -  age > 55 year
  Exclusion Criteria:
  -  Patients unfit for endovascular or open surgery (as judged by vascular surgeon)
  -  Failure to master the dutch language

Relevance to patient case: not relevant
Patient case: 63-year-old female with aortic aneurysm; genetic feature: ACTA2

Clinical trial: Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft Clinical Study

Summary: The Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft Single-Center Study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft in the treatment of abdominal aortic aneurysms.


Eligibility: Inclusion Criteria:
  -  Abdominal aortic aneurysm > 5.0 cm or 2 times the normal aortic diameter
  -  Abdominal aortic aneurysm with history of growth > 0.5 cm in 6 months
  -  Penetrating juxtarenal aortic ulcer > 10 mm in depth and 20 mm in diameter
  Exclusion Criteria:
  -  Age < 18 years
  -  Life expectancy < 2 years
  -  Pregnant or breast feeding
  -  Inability or refusal to give informed consent
  -  Unwilling or unable to comply with the follow-up schedule
  -  Additional medical restrictions as specified in the Clinical Investigation Plan
  -  Additional anatomical restrictions as specified in the Clinical Investigation Plan

Relevance to patient case: not relevant
Patient case: 63-year-old female with aortic aneurysm; genetic feature: ACTA2

Clinical trial: Point-of-Care Focused Cardiac Ultrasound in Assessing the Thoracic Aorta

Summary: The purpose of this prospective study is to compare point-of-care focused cardiac ultrasound (FOCUS) to thoracic computed tomographic angiography (CTA) in the measurement of ascending aortic dimensions. We hypothesize that FOCUS will demonstrate good agreement with CTA in the measurement of ascending aortic dimensions and accurately detect dilation and aneurysmal disease.

Detailed description: Nonspecific chest pain is frequently encountered in the emergency department. Accounting for over 13,000 deaths annually, aortic aneurysmal disease is a potential cause of chest pain.There are multiple diagnostic imaging modalities in practice to interrogate the thoracic aorta, with the most common being computed tomographic angiography (CTA), trans-thoracic echocardiography (TTE) and trans-esophageal echocardiography (TEE), each with its own advantages and limitations. In the ED setting, point-of-care (POC) focused cardiac ultrasound (FOCUS) is increasingly being used as an adjunct to the emergency physician's (EP) workup of undifferentiated chest pain. Based on prior retrospective data FOCUS and CTA appear to have good agreement. This studies aims to confirm these findings through prospective evaluation
  Specific Aims
  Aim 1: To prospectively compare Point of Care (POC) Focused Cardiac Ultrasound (FOCUS) to thoracic computed tomographic angiography (CTA) in the measurement of ascending aortic dimensions.
  Maximal diameter measurements of the ascending thoracic aorta by FOCUS will be compared to CTA. Bland Altman plots with 95% limits of agreement will be used to determine clinical and statistical significance.
  Hypothesis: 95% limits of agreement between FOCUS and CTA will be within +/- 5 mm.
  Aim 2: To determine the diagnostic accuracy of Point-of-Care Focused Cardiac Ultrasound for the detection of thoracic aortic dilation and aneurysm with computed tomographic angiography as the reference standard
  Sensitivity, Specificity and Accuracy of FOCUS will be computed with CTA as the reference standard.

Eligibility: Inclusion Criteria:
  -  All patients aged 18 years and older presenting to the ED for whom a thoracic CTA has been ordered.
  Exclusion Criteria:
  -  Refusal of verbal consent for ultrasound.
  -  Inability to obtain informed written consent for data collection from either the patient or the patients decision-making surrogate

Relevance to patient case: not relevant
Patient case: 63-year-old female with aortic aneurysm; genetic feature: ACTA2

Clinical trial: Screening for Abdominal Aortic Aneurysm and Abdominal Aortic Atherosclerosis by Hand-Held Ultrasonography

Summary: The purpose of this study is to determine the prevalence of abdominal aortic aneurysm (AAA) and abdominal aortic atheromatosis (AA-At) using a hand-held ultrasound by a general practitioner in Primary Health Care.

Detailed description: Pilot study that prospectively study a cohort of men over 50 years with cardiovascular risk factors: active smokers, former smokers, or hypertensive patients, attended in primary health care center. General Practitioner complete an ultrasonography training in an Ultrasound Unit under supervision of experienced radiologists using an standard ultrasound equipment and hand-held ultrasound (Trademark: VScan®, Manufacturer: General Electric, USA). All images and video recorded are blindly evaluated by a radiologist in order to establish the concordance in the interpretation of images between general practitioner and radiologist. Kappa index is calculated to study the agreement on the presence or absence of AAA and AA-At. Logistic regression analysis is used to determine the factors that influence the presence of AA-At

Eligibility: Inclusion Criteria:
  -  Smokers
  -  Former smokers.
  -  Hypertensive patients

Relevance to patient case: not relevant
Patient case: 63-year-old female with aortic aneurysm; genetic feature: ACTA2

Clinical trial: Haemodynamic Response to Aortic Surgery

Summary: Open elective abdominal aortic surgery is a high risk procedure involving clamping of the aorta. Indications include abdominal aortic aneurysm (AAA) or aortic occlusive disease (AOD) causing lower limb ischaemia.
  These patients are often regarded as one entity in postoperative study settings. However, previous studies indicate that risk profiles, inflammatory activity, and haemodynamic capacity may differ between these groups. The first aim of this study was to evaluate postoperative ICU-requirements after open elective abdominal aortic surgery, hypothesising that AAA-patients had longer ICU-stays and needed more mechanical ventilation or acute dialysis than did patients with AOD.
  The investigators see a relatively high incidence of postoperative acute kidney injury (AKI) following aortic surgery. Neutrophil Gelatinase Associated Lipocalcin (NGAL) may be useful in the early diagnosis of postopeative AKI. However, NGAL is also known as a marker of inflammatory activation. The ischaemia-reperfusion injury and subsequent inflammatory response to aortic cross clamping may per se induce a rise in NGAL despite intact renal function. Therefore NGAL may not be a reliable marker of AKI after AAS.
  The second aim of this study is to describe the changes in NGAL after AAS in patients with and without postoperative dialysis-dependent AKI.


Eligibility: Inclusion Criteria:
  -  CT verified aortic aneurysm or aortic occlusive disease
  Exclusion Criteria:
  -  age<18 y
  -  contraindications to the use of oesophagus doppler monitor, eg mycosis, perforation, stenosis.

Relevance to patient case: not relevant
Patient case: 63-year-old female with aortic aneurysm; genetic feature: ACTA2

Clinical trial: Performance and Safety of a Second Generation Antimicrobial Graft in Abdominal Position

Summary: Safety and performance of an anti-microbial vascular graft in the treatment of aneurysmal and occlusive disease of the abdominal aorta.

Detailed description: The purpose of this multi center, single arm study is to demonstrate the safety and performance of the Second Generation Anti-Microbial (InterGard Synergy) vascular graft in the treatment of aneurismal and occlusive diseases of the abdominal aorta.
  The primary endpoint is the assessment of primary and secondary graft patency. The secondary endpoints were the assessment of adverse events and the assessment of triclosan and silver contents in the serum over the time.

Eligibility: Inclusion Criteria:
  Patient aged 18-85 years
  Patient presenting with an aorto-iliac occlusion (obstruction of flow) or stenosis, or aorto-iliac aneurysm and eligible for a revascularization with a bifurcated graft
  Exclusion Criteria:
  Patient treated as an emergency
  Patient included in another investigation
  Patient pregnant or lactating or woman of childbearing potential
  Patient with a known allergy to the material device used (collagen, triclosan, silver)
  Patient with previous aorto-iliac bypass or replacement

Relevance to patient case: not relevant
Patient case: 63-year-old female with aortic aneurysm; genetic feature: ACTA2

Clinical trial: Pharmacokinetics of CRD007 in Patients With Abdominal Aorta Aneurisms.

Summary: The purpose of the study is to determine the plasma levels of CRD007 in patients with abdominal aortic aneurysms after the administration of single doses of tablets containing 10, 25 and 40 mg CRD007.


Eligibility: Inclusion Criteria:
  -  Infra-renal abdominal aortic aneurysm
  Exclusion Criteria:
  -  Significant concurrent disease or medical conditions that are deemed to interfere with the pharmacokinetics or the safety of CRD007 conduct of the trial

Relevance to patient case: not relevant
Patient case: 63-year-old female with aortic aneurysm; genetic feature: ACTA2

Clinical trial: Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix® System

Summary: The objective of this study is to assess the safety and effectiveness of the Endologix Nellix® System for the endovascular repair of infrarenal abdominal aortic aneurysms (AAA).

Detailed description: This study will evaluate the safety and effectiveness of the Nellix System among a wide range of physicians and in consecutively enrolled subjects to assess outcomes generalizability. Following appropriate government and ethics committee/IRB approval the Nellix® EndoVascular Sealing System will be implanted into eligible patients who are adequately informed and have consented to join the study. Enrolled patients will undergo a high resolution, contrast-enhanced computed tomography angiography (CT) scan of the relevant aortic and aortoiliac vasculature within three months of the scheduled procedure and at specified follow-up intervals post-implantation. Follow-up visits will occur at 30 days, 6 months, and annually to 5 years to assess aneurysm morphology, the status of the implanted devices, and relevant laboratory test results.

Eligibility: Inclusion Criteria:
  -  Male or female at least 18 years old;
  -  Informed consent understood and signed;
  -  Patient agrees to all follow-up visits;
  -  Have AAA with sac diameter ≥5.0cm, or ≥4.5 cm which has increased by >1.0cm in the past year.
  -  Anatomic eligibility for the Nellix System per the instructions for use:
  -  Adequate iliac/femoral access compatible with the required delivery systems (diameter ≥6 mm);
  -  Aneurysm blood lumen diameter ≤60mm;
  -  Most caudal renal artery to aortoiliac bifurcation length ≥100mm;
  -  Proximal non-aneurysmal aortic neck: length ≥10mm; lumen diameter 18 to 32mm; angle ≤60° to the aneurysm sac;
  -  Common iliac artery lumen diameter between 9 and 35mm with blood lumen diameter ≤35mm;
  -  Ability to preserve at least one hypogastric artery.
  Exclusion Criteria:
  -  Life expectancy <2 years;
  -  Psychiatric or other condition that may interfere with the study;
  -  Participating in enrollment of another clinical study
  -  Known allergy to device any device component;
  -  Coagulopathy or uncontrolled bleeding disorder;
  -  Ruptured, leaking or mycotic aneurysm;
  -  Serum creatinine level >2.0mg/dL;
  -  CVA or MI within three months of enrollment/treatment;
  -  Aneurysmal disease of the descending thoracic aorta;
  -  Clinically significant infrarenal mural thrombus (>5mm thickness over >50% circumference);
  -  Connective tissue diseases (e.g., Marfan Syndrome)
  -  Unsuitable vascular anatomy;
  -  Pregnant (females of childbearing potential only).

Relevance to patient case: not relevant