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

Clinical trial: Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms

Summary: The purpose of the study is to assess the safety and effectiveness of the GORE® EXCLUDER® Conformable AAA Endoprosthesis to treat an infrarenal aneurysm located in the abdominal aorta. Performance of the GORE® EXCLUDER® Conformable AAA Endoprosthesis will be judged by separate performance goals.

Detailed description: The study design is a prospective, nonrandomized, international, multicenter study comprised of two parallel substudies. The total subject population will be 190 subjects with 80 subjects assigned to the Short Neck Substudy and 110 subjects to the High Neck Angulation Substudy.
  This clinical study will include fifty-six sites in the US. Each enrolled subject will undergo periodic follow-up evaluations involving physical exams and contrast-enhanced computed tomography (CT) scans at specific, protocol-defined intervals for a period of five years following the GORE® EXCLUDER® Conformable AAA Endoprosthesis implant. Each Substudy will be evaluated and reported independently from each other according to the Safety and Effectiveness Endpoints. No comparative analyses between these substudies are planned.

Eligibility: Inclusion Criteria:
  1. AAA meeting any of the following criteria:
  -  Maximum diameter ≥50 mm
  -  Rapid growth (>5 mm in a 6 month period)
  -  Non-ruptured AAA presenting with clinical symptoms
  2. Adequate anatomy to receive the GORE® EXCLUDER® Conformable AAA Endoprosthesis, including:
  -  Adequate iliac / femoral access
  -  Infrarenal aortic neck diameter 16-32 mm
  -  Infrarenal aortic neck length ≥10 mm
  -  Aortic neck angle ≤ 90˚
  -  Distal iliac artery seal zone ≥10 mm
  -  Iliac artery diameter 8-25 mm
  3. An Informed Consent Form (ICF) signed by Subject
  4. Male or infertile female
  5. Able to comply with Protocol requirements including following-up
  6. Life expectancy > 2 years
  7. Age ≥ 21 years
  Exclusion Criteria:
  1. Mycotic or ruptured aneurysm
  2. Known concomitant thoracic aortic aneurysm which requires surgical intervention
  3. Renal insufficiency defined as creatinine > 2.5 mg/dL or patient undergoing dialysis
  4. New York Heart Association (NYHA) class IV
  5. Aneurysmal, dissected, heavily calcified, or heavily thrombosed landing zone(s)
  6. Severely tortuous or stenotic iliac and / or femoral arteries
  7. Patient has body habitus or other medical condition which prevents adequate delineation of the aorta
  8. Participating in another investigational device or drug study within 1 year of treatment
  9. Systemic infection which may increase the risk of endovascular graft infection
  10. Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome
  11. Planned concomitant surgical procedure or major surgery within 30 days of treatment date
  12. Known history of drug abuse
  13. Known sensitivities or allergies to the device materials

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

Clinical trial: Post-market Clinical Follow-up Study With Magnetic Resonance Imaging Conditional Guide Wire

Summary: This is post-market clinical follow-up study on 25 consecutive patients in two centers to evaluate the safety and performance of magnetic resonance imaging conditional guide wire and the acceptability of identified risks in the clinical evaluation and to detect emerging risks on the basis of factorial evidence.The procedure will be done in patients with a clinical indication for cardiac magnetic resonance and conventional catheterisation.

Detailed description: This is post-market clinical follow-up study on 25 consecutive patients in two centers to evaluate the safety of a guide wire conditional for use in magnetic resonance imaging and the acceptability of identified risks in the clinical evaluation and to detect emerging risks on the basis of factorial evidence.
  The guidewire is used to access the patients central circulatory system and in particular for the introduction and exact placement of a pressure catheter to measure the pressure gradient over the aortic arch. The procedure will be done in patients with a clinical indication for cardiac magnetic resonance and conventional catheterisation.Patients need to have a body weight over 40 kg and the introduction of a 5 French catheter should be possible. The primary endpoint is the measurement of procedural success, defined as successful insertion, steerability and visibility in MRI, in the absence of device related adverse events such as damage to vessel wall. In addition structural integrity of the instruments is to be assessed.

Eligibility: Inclusion Criteria:
  -  patients with clinical indication for cardiac magnetic resonance and conventional diagnostic catheterisation
  -  patients with body weight of > 40 kg in which the introduction of an introducer of > 5 French is possible.
  -  subject provided written informed consent using the approved consent form or in case of a minor the subject provided written assent and its legal guardian provided written informed consent.
  Exclusion Criteria:
  -  major surgery in the last 42 days
  -  history of irreversible bleeding disorder
  -  contraindication to cardiac magnetic resonance
  -  Contraindications to guidewire procedures, such as evidence of active infection
  -  women of child-bearing potential who cannot provide a negative pregnancy test
  -  chronic total occlusion.

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

Clinical trial: GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Type IV Thoracoabdominal Aortic Aneurysms

Summary: This study will assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in the treatment of Aortic Aneurysms Involving the Visceral Branch Vessels.

Detailed description: This is a prospective, non-randomized study designed to assess the feasibility of the TAMBE Device in the treatment of patients with aortic aneurysms involving the visceral branch vessels. A maximum of 10 Subjects will be treated under this Protocol. This clinical study will include up to six sites in the US. Each enrolled subject will undergo periodic follow-up evaluations involving physical exams, contrast-enhanced computed tomography (CT) of chest, abdomen and pelvis, creatinine measurement, abdominal ultrasound (optional) at specific, protocol-defined intervals for a period of five years following the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis impant.

Eligibility: Inclusion Criteria:
  1. Aortic aneurysm involving the visceral vessels requiring treatment
  2. Adequate access for TAMBE Device components
  3. Appropriate aortic anatomy to receive the TAMBE Device
  4. Age ≥ 18 years at the time of informed consent signature
  5. Male or infertile female
  6. The patient is considered high risk for open repair as deemed by the treating physician
  7. Capable of complying with protocol requirements, including follow-up
  8. An Informed Consent Form signed by Subject or legal representative Note: Additional Inclusion Criteria may apply
  Exclusion Criteria:
  1. Prior aortic surgery
  2. Ruptured or leaking aortic aneurysm
  3. Aneurysmal dilatation due to chronic aortic dissection
  4. Infected aorta
  5. Mycotic aneurysm
  6. Life expectancy <2 years
  7. Myocardial infarction or stroke within 6 weeks of treatment
  8. Systemic infection which may increase risk of endovascular graft infection
  9. Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
  10. Participation in another drug or medical device study within 1 year of study enrollment
  11. History of drug abuse, e.g. cocaine or amphetamine or alcohol, within 1 year of treatment
  12. Tortuous or stenotic iliac and / or femoral arteries and the inability to use a conduit for vascular access
  13. Known sensitivities or allergies to the device materials
  14. Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin
  15. Patient has body habitus or other medical condition which prevents adequate fluoroscopic and CT visualization of the aorta
  16. Renal Insufficiency Note: Additional Exclusion Criteria may apply

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

Clinical trial: Risk of Rupture of Aneurysms of the Thoracic Ascending Aorta (ATA) From the Dynamic Imaging

Summary: Aneurysms of the thoracic ascending aorta are a serious pathology which may threatens life by rupture or dissection. Their incidence is estimated at 10.4 per 100,000 people. At present, the only parameter for assessing the risk of complication is the maximum diameter of the aneurysm. The only way to avoid a complication is a surgical replacement of the aneurysmal aorta by a prosthetic tube. This procedure is performed by sternotomy and with extracorporeal circulation and its death rate ranges between 3% and 5%. Surgical repair is indicated when the diameter of the aneurysm exceeds 5.5 cm for degenerative atheromatous aneurysms or 5 cm in a patient with genetic disorder of connective tissue (Marfan disease or Ehlers-Danlos syndrome). However, there are aneurysms with diameter greater than the surgical threshold which remain stable. Conversely, complications have been described for aneurysms less than 4.5 cm in diameter. The criterion of diameter appears therefore as inadequate to assess the risk of complication of an aneurysm of the ascending aorta.Multiple methods have been described in the literature. One of them relies on in vitro mechanical testing on healthy or aneurysmal tissue. Another method is the vivo analysis from imaging (CT, MRI or ultrasound). So far, no algorithm is robust enough for predicting the risk of complication better than the universally used criterion of diameter.
  The pathophysiology of these aneurysms has also been explored from histological studies. The investigators know that the microstructure of the aortic wall of an aneurysm is deteriorated with a degradation of elastin fibers and collagen that determine to a large extent its biomechanical behavior. Histological analysis appears inseparable from biomechanical analysis.


Eligibility: Inclusion Criteria:
  -  Diameter of ATA exceeds 5.5 cm
  -  Diameter of ATA exceeds 5 cm in a patient with genetic disorder of connective tissue (Marfan disease or Ehlers-Danlos syndrome)
  -  Diameter of ATA exceeds 5 cm in a patient with aortic valvulopathy
  -  Written consent
  Exclusion Criteria:
  -  Contra-indication to MRI
  -  Chronic insufficiency kidney

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

Clinical trial: Estimation of Biomechanical Aortic Wall Properties in Healthy and Aneurysmal Aortas Using Novel Imaging Techniques

Summary: The primary aim of this study is to establish the practicality of using two novel imaging modalities for the assessment of biomechanical properties of the aorta.

Detailed description: Patients with Abdominal Aortic Aneurysm, (AAA), will be identified within the vascular surgery practice. Those patients who meet standard indications for surgery including symptomatic AAA, size >5.0-5.5 cm, or rapidly enlarging >0.5 cm per 6 months will have standard pre-operative work-up which includes magnetic resonance angiogram (MRA) and Echocardiogram (ECHO). These pre-operative studies will be modified for the study patients to include electrocardiogram(ECG)-gating (coupled with MR angiogram) and 2-Dimensional speckle-tracking ultrasound of the abdominal aorta. Patients in the study will be followed for 1 year. Measurements will be analyzed for any relationship between aortic wall properties and clinical outcomes such as aneurysm growth, rupture risk or aortic dissection. This study will be comparing 3 groups of patients: no surgery (surveillance), open surgery, and endovascular aneurysm repair (EVAR).

Eligibility: Inclusion Criteria:
  -  Patients >18 years of age with ability to provide informed consent.
  -  Patients with either symptomatic or asymptomatic AAA as defined by aortic diameter ≥ 1.5x normal diameter.
  -  Patients with non-aneurysmal aortas who require aortic contrast imaging or echocardiography for preoperative planning or other reason.
  Exclusion Criteria:
  -  Patients with contraindication to IV contrast such as allergy or severe kidney dysfunction.
  -  Patients who do not require contrast imaging or echocardiogram as part of their care plan.
  -  Terminally ill patients, and patients with estimated life expectancy of ≤ 6 months.
  -  Patients unable to tolerate magnetic resonance imaging.

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

Clinical trial: Zenith® Low Profile AAA Endovascular Graft

Summary: This extended investigation is to provide continued physician access to the device and collect confirmatory safety and effectiveness data.


Eligibility: Inclusion Criteria:
  •Subject has at least one of the following
  -  Aortic or aortoiliac aneurysm
  -  Iliac aneurysm
  -  Aneurysm with a history of growth
  Exclusion Criteria:
  -  Less than 18 years of age
  -  Inability or refusal to give informed consent
  -  Life expectancy less than 2 years
  -  Pregnant of breastfeeding or planning on becoming pregnant with 60 months
  -  Unwilling to comply with the follow-up schedule

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

Clinical trial: Zenith® Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Continued Access Study

Summary: The Zenith®Fenestrated AAA Endovascular Graft Clinical Study is a clinical investigation approved by the US FDA to study the safety and effectiveness of the Zenith® Fenestrated AAA Endovascular Graft in the treatment of abdominal aortic and aorto-iliac aneurysms.


Eligibility: Inclusion Criteria:
  -  Abdominal aortic and aortoiliac aneurysms with diameter greater than or equal to 5 cm
  Exclusion Criteria:
  -  Proximal neck less than 4 mm or greater than or equal to 15 mm in length unless otherwise compromised to preclude seal
  -  Renal artery stenosis greater than 50 percent

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

Clinical trial: Neurophysiological Intraoperative Monitoring During Aortic Surgery

Summary: The primary objective of this study is to evaluate if the motor-evoked potentials/motor action potential amplitude ratio and motor action potential amplitude measurement are useful in detecting spinal cord ischemia during thoracoabdominal aortic aneurysms surgery.
  The secondary objective is to evaluate the presence of a correlation between neurophysiological changes and other factors (such as surgical maneuvers, anesthetic and physiologic changes) in order to find which factor is the most important in determining spinal cord ischemia.
  This study is an observational, single-center, prospective study on patients with thoracoabdominal aortic aneurysms undergoing surgical repair with intraoperative motor-evoked potentials and somatosensory evoked potentials monitoring.


Eligibility: Inclusion Criteria:
  -  satisfied criteria for Intraoperative neurophysiological monitoring;
  -  sign a written informed consent to participate in the study.
  Exclusion Criteria:
  -  No exclusion criteria

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

Clinical trial: A Study of Remote Ischaemic Preconditioning in Patients With Atherosclerosis Undergoing Vascular Surgery

Summary: The purpose of this study is to evaluate the effect of preoperative remote ischaemic preconditioning (RIPC) on organ damage and the functional characteristics of arteries in patients undergoing vascular surgery. In addition, we investigate the connection between RIPC and changes in the functional characteristics of arteries and low molecular weight metabolites.


Eligibility: Inclusion Criteria:
  -  patients who are willing to give full informed consent for participation and
  -  who are undergoing open abdominal aortic aneurysm repair or
  -  who are undergoing endovascular aortic aneurysm repair or
  -  who are undergoing lower limb revascularization surgery or
  -  who are undergoing carotid endarterectomy
  Exclusion Criteria:
  -  patients under age of 18
  -  patients who are pregnant
  -  patients with known malignancy during last 5 years
  -  patients with permanent atrial fibrillation or flutter
  -  patients with symptomatic upper limb atherosclerosis
  -  patients who require home oxygen therapy
  -  patients with eGFR < 30 ml/min/1.73 m2, measured preoperatively
  -  patients who have had myocardial infarction during last month
  -  patients who have had upper limb vein thrombosis
  -  patients who have undergone vascular surgery in the axillary region
  -  patients who are not able to follow the study regimen

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

Clinical trial: Using US to Evaluate Aortic Aneurysm Size Based on 3D Co-registration to Previous CT Scan

Summary: Examine a new method based on fusion between ultrasound (US) and previous ultrasound/computerized tomography(US/CT) studies to evaluate the size of abdominal aneurysm and measure the changes over time and following invasive repair procedure.

Detailed description: Selection test for assessing aortic aneurysm is CT angio, it performed after injection of contrast material and allows a complete demonstration of the blood vessels. This test exposes the patient to ionizing radiation and the injection of iodine contrast medium. Repeated tests pose a risk of developing a malignancy in the future due to the use of ionizing radiation and risk of renal impairment and allergic reactions due to the injection of contrast material. Ultrasound is another test that enables the detection and evaluation of aortic aneurysm. Patients with a known diagnosis of aortic aneurysm detected on CT are required to continuous monitoring in light of its growth over time and the risk of rupture.
  Using Co-registration over the US device will enable to conduct a US directed aorta examination, which uses the information produced from the CT as a "roadmap" for detection and localization of the aneurysm. That can theoretically improve detection capabilities and characteristics of the aneurysm and outcomes of the invasive treatment.

Eligibility: Inclusion Criteria:
  •Patients with abdominal aortic aneurysm diagnosis in clinical follow-up or after an invasive procedure to fix it.
  Exclusion Criteria:
  -  Inability to perform Ultrasound
  -  Pace maker
  -  Hemodynamic instability
  -  Inability to cooperate in US examination
  -  Pregnant Women - does not undergo CT

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

Clinical trial: Prevalence of Genetic Polymporphism on RNF213 rs112735431 Gene in Non-cardioemboli Ischemic Cerebrovascular Disease

Summary: To explore the prevalence of genetic polymorphism on RNF213 rs112735431 gene in non-cardioembolic ischemic cerebrovascular disease in Thai patients.

Detailed description: This is an cross-sectional observational study in Chulalongkorn hospital, to determine the prevalence of genetic polymorphism on RNF213 rs112735431 gene in non-cardioembolic ischemic cerebrovascular disease. Patients who are potentially eligible for study participation will be identified through a chart review of patients who were admitted in Chulalongkorn Hospital for acute ischemic stroke treatment.

Eligibility: Inclusion Criteria:
  -  Nationality in Thailand
  -  Age equal or more than 18 years
  -  Clinical and imaging diagnosis of acute ischemic stroke
  -  Patient consent to participate in the research
  Exclusion Criteria:
  -  High risk for cardioembolic stroke by TOAST classification
  -  Contraindication for venipuncture
  -  Pregnancy or breast feeding patient
  -  History of head and neck radiation
  -  Down's syndrome
  -  Marfan syndrome
  -  Autoimmune disease such as SLE
  -  Ongoing malignancy or remission of malignancy less than 1year

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

Clinical trial: CardiAQ-Edwards™ Transcatheter Mitral Valve Replacement (TMVR) Study

Summary: Clinical study to evaluate the safety and performance of the CardiAQ-Edwards™ Transcatheter Mitral Valve

Detailed description: The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the CardiAQ-Edwards™ Transcatheter Mitral Valve with transapical and transseptal delivery systems in patients with degenerative or functional/ischemic mitral regurgitation.

Eligibility: Inclusion Criteria:
  -  NYHA ≥ II
  -  Moderate/severe or severe mitral regurgitation
  -  Prohibitive risk for open-heart surgery
  -  Meets anatomical criteria
  Exclusion Criteria:
  -  Unsuitable anatomy
  -  Need for emergent or urgent surgery
  -  Prior mechanical aortic valve replacement
  -  Any prior surgical or transcatheter repair (excluding balloon valvuloplasty) or replacement of the mitral valve
  -  Preexisting device in the left ventricular apex
  -  Clinically significant, untreated coronary artery disease
  -  Limited life expectancy (< 12 months)
  -  Active infection

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

Clinical trial: Evaluation of Aortic Aneurysms With Focus on Wall Stress and Wall Rupture Risk

Summary: Retrospective study to evaluate the impact of computational wall stress analysis based on computed tomography (CT) of ruptured and not-ruptured aortic aneurysms as an additional predictor for rupture with dedicated software.

Detailed description: In patients with known aortic aneurysm who received clinically indicated CT during a time period from 01/2004-12/2013 the CT data was evaluated with dedicated software, A4clinics, VASCOPS GmbH, Graz, Austria. The following parameters will be evaluated: exterior and luminal diameter, intraluminal thrombus (ILT) thickness, vessel-, luminal- and intraluminal thrombus volume, peak wall stress (PWS), peak wall rupture risk (PWRR), von Mises-stress and rupture risk-index in the ILT.

Eligibility: Inclusion Criteria:
  Clinical indicated CT data from patients with known aortic aneurysms.
  Clinical indication was:
  -  Follow up CT examination by known aortic aneurysm
  -  Patient with known aortic aneurysm with new acute clinical symptoms
  -  Patients with clinical suspicion of aortic aneurysm
  Exclusion Criteria:
  -  known exclusion criteria for CT examination as known allergy to iodine or contrast media
  -  known pregnancy

Relevance to patient case: not relevant